[Facility] Dental Policy and Procedure Manual Template This document is a template for you to construct a comprehensive dental policy and procedure manual. This document CANNOT be used as is. You must examine each procedure and match the policy to your practices. Throughout the document you will see type in Bold and type in italics. Bold type usually means you must insert a specific name (facility, department, individual or State). Italicized type usually indicates an example. Check each policy for your facility’s unique requirements and practices. Many policies are based on professional organizations’ recommendation s or guidelines. Those policies include a statement such as: This facility adheres to the [Organization] guidelines for [topic]. According to the [organization’s] [Year] [position, policy or clinical guidelines]: You may elect to include this statement and then use the entire recommendation or guideline in quotes. It is recommended you use the authoritative source whenever possible. You may use the above statement and simply insert your facility’s name, the topic, the organization, date and type of recommendation in the bold sections. For more information or assistance in using this document contact: M. Catherine Hollister, RDH, MSPH, PhD Director-Nashville Area Dental Support Center United South and Eastern Tribes, Inc. 711 Stewarts Ferry Pike Nashville, TN 37214 mary.hollister@ihs.gov Original Template: Revised: 2009 2012 1 Acknowledgements: Thanks to all of the dental programs and individuals who have contributed to this document. Those who have contributed enitre policies, statements, recommendations or assisted in revising or editing include: Joyce Biberica, DDS, MS Cherokee Indian Hospital Authority Tim Ricks, DDS, MPH Nashville Area Office Harry Brown, MD Nashville Area Office Jeffrey Stuart, DDS Catawba Health Center Cherokee Indian Hospital Authority Dental Policy and Procedures Manual Michael Vito, DDS Cattauagus Health Center Seneca Nation Kit Grosch, MPH Nashville Area Office Cathy Hollister, RDH, MSPH, PhD United South and Eastern Tribes, Inc. Byron Jasper, DDS United South and Eastern Tribes, Inc Dana Johnson DDS Passamaquoddy Indian Township Health Center Northern Navajo Medical Center Shiprock, NM John Otteson, DDS Oneida Nation Health Center Pat Planck, RDH Oneida Nation Health Center Nick Porcello Lionel R. John Health Center Seneca Nation . 2 Sample Policy Authorization Formats Single Title Page to cover all policies [Tribe or Facility] Dental Policies and Procedure Manual Policy/Procedure Type: □ Administrative □ Interdepartmental Departmental Department(s): Dental Effective Date: Revision Date: Supersedes: Signatures: ___________________________/_____________ Date ___________________________/_____________ Date ___________________________/_____________ Date Header for each individual policy Policy & Procedure Statement Subject: Policy Name Effective Date: Revision Date: Supersedes: P&P Number: A.1 Signatures: 3 Table of Contents Sample Title Page with Signatures ................................................... 3 Section A: Administration A.1. Dental Program Policies and Procedures .................................. 6 A.2. Organizational Chart .................................................................. 9 A.3. Dental Program Summary ......................................................... 10 A.4. New Employee Orientation ........................................................ 12 A.5. Ordering/Requisitioning Supplies ............................................... 15 A.6. Privileging/Credentialing ............................................................ 16 A.7. Documentation........................................................................... 17 A.8. Pain Documentation .................................................................. 19 A.9. Medical Records ........................................................................ 22 A.10. Staff Assignments and Duties .................................................. 23 A.11. Staff Training ........................................................................... 24 A.12. Students, Trainees and Volunteers ......................................... 25 A.13. Leave ....................................................................................... 28 A.14. Dress Code .............................................................................. 30 A.14. Patient Satisfaction .................................................................. 31 Section B: Clinical Services B.1. Appointment Procedures ........................................................... 34 B.2. After Hours, Emergency Dental Care, and Triage ..................... 37 B.3. On Call ....................................................................................... 40 B.4. Guidelines for Prenatal Oral Health Care .................................. 41 B.5. Intoxicated Persons ................................................................... 42 B.6. Standing Orders for Dental Auxiliary Staff ................................. 43 B.7. Medical History .......................................................................... 44 B.8. Schedule of Services ................................................................. 46 B.9. Completed Treatment ................................................................ 51 B.10. Referral Procedures ................................................................. 52 B.11. Dental Laboratory ................................................................... 54 B.12. Protective Stabilization............................................................. 56 B.13. Caries Stabilization .................................................................. 58 B.14. Informed Consent .................................................................... 59 B.15. Radiography ............................................................................ 61 B.16. Pharmacy/Prescriptions ........................................................... 66 B.17. Dental Pain Management ........................................................ 67 B.18. Pharmacological Management of Oral Infections .................... 78 B.19. Extracted Teeth ....................................................................... 84 B.20. Hypertension Screening and Treatment Guidelines ................ 85 4 B.21. Premedication to Prevent Infective Endocarditis ..................... 86 B.22. Premedication for Patients with Complete Joint Replacement 89 B.23. Medical Emergencies in the Dental Clinic ................................ 96 B.24. Reporting Domestic Violence................................................... 99 B.25. Pathology ................................................................................. 101 B.26. Clinical Oral Disease Prevention/Health Promotion ................. 102 B.27. Nitrous Oxide ........................................................................... 103 B.28. Conscious Sedation ................................................................. 108 Section C: Environment C.1. Infection Control ........................................................................ 119 C.2. Radiological Protection .............................................................. 135 C.2. Equipment Maintenance and Product Recalls ........................... 136 C.3. Nitrous Oxide Safety .................................................................. 136 C.4. Fire Plan .................................................................................... 139 C.5. Mercury Hygiene........................................................................ 140 C.6. Safety ........................................................................................ 144 C.7. Precious Metal Recovery ........................................................... 146 C.8. Hazardous Communications...................................................... 147 Section D: Quality Assurance D.1. Continuous Quality Improvement (Clinical) ............................... 174 D.2. Risk Management/Program Monitoring ..................................... 177 Program Monitoring Tool .......................................................... 178 Sample Employee Training Tracking Form ............................... 194 Sample Facility Review Tracking Form ..................................... 195 Section E: Community Health E.1. Community Health Promotion/Disease Prevention .................... 196 E.2. Head Start/Preschool ................................................................. 199 E.3. Infection Control for Portable Settings ....................................... 200 E.4. Oral Health Surveillance ........................................................... 202 5 SECTION A—ADMINISTRATION A.1 DENTAL PROGRAM POLICIES AND PROCEDURES PURPOSE The purpose of the dental program is to provide quality clinical dental services in a professional and efficient manner to those eligible for care at [Facility] Health Department. This manual will act as a guide of policies to follow procedures set by the [Facility] Health Department, and the Dental Clinic. PROCEDURE Mission Statement The [Facility] Health Department is dedicated to the healing and well being of the individual, family and community. Vision Statement To commit ourselves to continuously improve all that we do. To provide our patients with the best possible health care and to support them in their healing process. To support healthy lifestyle choices and educate on health related issues. To focus our daily affairs on our staff and community in order to provide quality services and information in a trustworthy manner. The dental department will serve as an integral part of the [Facility] Health Department providing services in the diagnosis, treatment and prevention of oral disease. This treatment may include emergency care, preventive services, oral surgery, restorative procedures, root canal therapy and prosthetics. Services will be based on established priorities as listed in the Schedule of Oral Health Services for the Indian Health Service and on available appointments. The dental clinic will also serve as a referral center. Referrals will be made based on established priorities and available resources. Policy Implementation The policy of the dental department will be implemented through an organizational chart, (See Policy A.2), and through a series of policies and procedures that follow. This department is part of the entire facility and works within its guidelines. This department does not function independently. Many patients seen by the dental clinic and staff of the dental clinic require services from other departments of the facility. Organizational Integration The organizational structure of the facility and the department do not allow this department to work independently when delivery of care is comprehensive in its nature. The mouth and oral 6 structures are only a portion of the patient and the total patient is our concern. Medical complications, patient education, and treatment of that patient in the dental department are coordinated with all patient care delivery departments and support departments. The dental department is a portion of the clinical division of that is supervised by the health director. Scheduled meetings are held to discuss concerns and interaction with the Support Services Division. Organizational tables will outline this interaction and will follow this section. Short Range Goals: Short term planning looks at departmental activities over the next two to five years. Short-term goals are devised as a process to attain the Long Range Planning Goals. Short Range Planning include the following: Increased presence in community based activities such as schools, senior citizen facility, head start and other congregations of community members. Increased communications with tribal officials and community in addressing their concerns for dental care. Increase monitoring of services provided in the clinic and activities outside the dental clinic. Increase patient interaction and determination of treatment offered. Use of patient input to solve delivery of dental care inadequacies. Long Range Goals: Departmental planning is tied to resources and planning of the entire Facility. This planning includes annual review of equipment, personnel, and patient demand. This is actually a strategic planning procedure that is used to function within a five year plan. Additions and modifications to this plan affect both clinical and community components of the dental department. Plans for staffing, procurement and departmental renovation are submitted to facility administration for approval and funding. Committees of the departments or services involved accomplish planning for projects that concern or run jointly. This long-range plan includes: More aggressive third party participation. This includes Patient Registration, Benefits Coordination, Coding and Billing. Expansion of community contact to include screening and educational programs for target populations that include the elderly, the young, those with specific medical needs; for example diabetics and other groups requiring primary attention of this community. Continued interaction with the private and public sector dental colleges and organizations, including Federal and State. Become more patient oriented in action and policy. 7 Budget The departmental budget is developed each fiscal year. This planning includes the recurring allowance and expected expenditures for salary, transportation, training, supplies, and equipment. This budget is developed by the health director. Budgeted items that are planned by several departments are negotiated prior the beginning of the fiscal year. Staffing Staffing levels are determined by the tasks involved in delivery of oral health care to this community and these levels are also determined by a budgetary component with remote decisions affecting the number of employees in this department. Recommend staffing levels include (state desired staffing levels). Staff Competency Staff competency is measured by multiple means. Positions descriptions are in place for all staff. Each position also has a performance appraisal plan to measure the incumbent's performance and is done annually. Other factors include annual continuing education for all employees necessary to maintain licensure and as required by the [State] and the [Facility] Health Department. 8 A.2 ORGANIZATIONAL CHART [INSERT FACILITY ORGANIZATIONAL CHART] 9 A.3 DENTAL PROGRAM SUMMARY PURPOSE To identify staff lines of authority and responsibility, describe the physical components of the dental program, and general principles of oral health care delivery. PROCEDURE Description and Organization The [Facility] Dental Program is directly responsible to the health director. The Dental Program is the responsibility of the [individual]. Staff [Staff, eg. Dentist, dental assistant, hygienists, receptionist, others] staff the dental clinic. Referrals to private specialists are provided through contract health service funds or other funds identified by the [Facility] Health Department. Scope of Work The dental program is designed to provide basic preventive and restorative dental services to the entire family through education, disease prevention services, diagnosis and treatment of oral health problems. Each adult is responsible for his/her dental health. Parents/legal guardians are responsible for the dental health of their legal wards. Medically Necessary Care This facility adheres to the American Academy of Pediatric Dentistry’s (AAPD) guidelines for medically necessary care (MNC). According to the AAPD’s 2011 guidelines: MNC is defined as: “Medically necessary care (MNC) is the reasonable and essential diagnostic, preventive, and treatment services (including supplies, appliances, and devices) and follow-up care as determined by qualified health care providers in treating any condition, disease, injury, or congenital or developmental mal-formation. MNC includes all supportive health care services that, in the judgment of the attending dentist, are necessary for the provision of optimal quality therapeutic and preventive oral care. These services include, but are not limited to, seda-tion, general anesthesia, and utilization of surgical facilities. MNC must take into account the patient’s age, developmental status, and psychosocial well-being, in addition to the setting appropriate to meet the needs of the patient and family.” (AAPD, 2011. Available online at http://www.aapd.org/media/Policies_Guidelines/D_MedicallyNecessaryCare.pdf) Providing Medically Necessary Care: “Dental care is medically necessary to prevent and eliminate orofacial disease, infection, and pain, to restore the form and function of the dentition, and to correct facial disfiguration or dysfunction. MNC is based upon current preventive and therapeutic practice guidelines formulated by professional organizations with recognized clinical expertise. Expected benefits of MNC outweigh potential risks of treatment or no treatment. Early detection and management of oral conditions can improve a child’s oral health, general health and well-being, school readiness, and self-esteem. Early recognition, prevention, and intervention could result in savings of health care dollars for 10 individuals, community health care programs, and third party payors. Because a child’s risk for developing dental disease can change over time, continual professional reevaluation and preventive maintenance are essential for good oral health. Value of services is an important consideration, and all stakeholders should recognize that cost-effective care is not necessarily the least expensive treatment. The AAPD encourages: 1. oral health care to be included in the design and provision of individual and community-based health care pro-grams to achieve comprehensive health care. 2. establishment of a dental home for all children by 12 months of age in order to institute an individualized pre-ventive oral health program based upon each patient’s unique caries risk assessment. 3. health care providers who diagnose oral disease to either provide therapy or refer the patient to a primary care dentist or dental/medical specialist as dictated by the nature and complexity of the condition. Immediate intervention is necessary to prevent further dental destruction, as well as more widespread health problems. 4. evaluation and care provided for an infant, child, or adolescent by a cleft lip/palate, orofacial, or craniofacial de-formities team as the optimal way to coordinate and deliver such complex services. 5. the dentist providing oral health care for a patient to determine the medical indication and justification for treatment. The dental care provider must assess the patient’s developmental level and comprehension skills, as well as the extent of the disease process, to determine the need for advanced behavior guidance techniques such as sedation or general anesthesia.” (AAPD, 2011. Available online at: http://www.aapd.org/media/Policies_Guidelines/P_MedicallyNecessaryCare.pdf) These principles of Medically Necessary Care will be applied to all dental services for patients of all ages. Patient Rights Describe process of informing patients of their rights. Example: Upon registration patients are informed of their rights and responsibilities. Each patient or parent/guardian acknowledges understanding of these policies by signing a form which is kept in their patient registration chart. Protected Information The confidentiality of patient records will be maintained according to the Privacy Act of 1974 and Health Insurance Privacy and Accountability Act (HIPAA). Any release of patient information not covered under “Routine Uses” provision of the Privacy Act and/or HIPAA must be authorized by the patient, the patient's legal guardian or by court order. Patients are informed of their HIPAA rights at registration. Grievances Grievances concerning the dental program can be brought by patients directly to the [appropriate individual]. The grievance will be fully investigated and the patient informed of the findings in a timely manner. 11 A.4 NEW EMPLOYEE ORIENTATION PURPOSE To ensure each dental clinic employee receives personnel policies of [facility] and all information necessary to deliver quality dental care. PROCEDURE When reporting for duty the employee will be given the standard General Orientation form by their supervisor, other facility departments, and facility management. Dental orientation will consist of the following: [Revise as needed] Review the Dental Clinic Policy, Procedures, Rules and Regulations within seven days. Complete Dental Clinic Orientation Checklist within two weeks. A copy of the completed orientation form will be filed in the employee’s record. The standard orientation form can be obtained from the [personnel office]. Orientation will be conducted by [appropriate individual]. 12 ORIENTATION FOR DENTAL STAFF [Sample Orientation Checklist. Revise as needed] Name: _______________________________________ Employed On Date: _________________________ GENERAL FACILITY ORIENTATION FACILITY ORIENTATION PACKET GIVEN. ADMINISTRATIVE PAPER WORK FOR PAYROLL DEDUCTIONS, HOUSING ALLOWANCE, AND TRAVEL VOUCHER INTRODUCE NEW EMPLOYEE TO DENTAL STAFF, DENTAL CLINIC, DENTAL EQUIPMENT, EMERGENCY KIT, AND PROCEDURES. PROVIDE KEYS TO THE CLINIC. EXPLANATION OF COMMUNICATION PROCEDURES, P.A. SYSTEM, TELEPHONE POLICY. TOUR OF THE FACILITY AND INTRODUCTION TO THE STAFF. LEAVE POLICY INTRODUCTION TO CLINIC AND TRIBAL PERSONNEL INTRODUCTION AT EXECUTIVE COMMITTEE MEETING INTRODUCTION TO CHR'S, WIC, AND HEAD START PERSONNEL. 13 DATE GIVEN or NA ORGANIZATIONAL STRUCTURE FACILITY AND DEPARTMENTS. REVIEW OF FIRE PLAN. REVIEW OF DISASTER PLAN GRIEVANCE PROCEDURES PRIVACY ACT AND PATIENT RIGHTS FACILITY POLICY MANUAL PROPERTY CUSTODIAL PROCEDURES DENTAL DEPARTMENT ORIENTATION DENTAL POLICY AND PROCEDURES SYNOPSIS OF DENTAL PROGRAM WORK SCHEDULE REVIEW OF RECORD KEEPING REVIEW ORDERING OF SUPPLIES REVIEW ORAL HEALTH PROGRAM GUIDE COMPLETE STANDARDS OF PERFORMANCE REVIEW CLINICAL SPECIALTIES MANUAL 14 A.5 ORDERING/REQUISITIONING SUPPLIES PURPOSE To establish an efficient system for monitoring and procuring supplies necessary for the dental clinic and related community dental programs. PROCEDURE The [appropriate staff] will be responsible for maintaining the supply system, the [appropriate staff] shall act as the alternate. Ordering Supplies [Example] Supplies for the Clinic will come from three sources. One is (primary) the Central Supply Service Center at Ada, Oklahoma. The other sources are from (secondary) manufactures with GSA contracts and (tertiary) open purchasing supplies from the manufacturers. Monthly an issue book will be sent from Central Supply Service Center to the dental clinic. Within three days of receiving the book, the items needed should be recorded and the book returned to Central Supply. When Central Supply delivers the order the issue book will need to be signed and returned to the facility supply clerk. The staff dental officer shall keep a register of computer generated stock issues for each month with cost/quantity data on file in the clinic. Outside purchases should be obtained from vendors with a government contract or at the lowest possible price. Form 393 will need to be completed and submitted to the Chief Dental Officer for approval. After approval the form will be submitted to the facility administration for processing. Approval will be based on available funding resources. The staff dental officer shall maintain a register of all purchases utilizing direct issue funds. If a shortage of needed supplies should occur during the month, an emergency requisition may be prepared and have General Services process it with the Health Director's approval. Inventory Describe system of monitoring inventory 15 A.6 PRIVILEGING/CREDENTIALING PURPOSE The primary purpose of this process is to ensure that only practitioners who are qualified and competent to practice are delivering services to patients. The process not only helps to enhance patient safety, but it also helps to protect the health care organization from liability. Credentialing is the process of documenting the licensure, professional education and training, experience, current competence, and health status of a practitioner. Privileging is establishing the manner in which a practitioner is allowed to practice (i.e., the scope of practice and types of procedures carried out by the medical practitioner). PROCEDURE [Facility] Dental Program will follow Medical/Dental Staff Bylaws or other guidance established by the Facility’s Governing Body. Copies are on file [location]. Dental Privileges Request Forms and Application for Appointment to the Medical Staff are completed by each dentist, [and hygienist if Bylaws specify dental hygienists as providers] and a copy kept in [location]. All visiting and temporary staff will follow the guidelines outlined in the Medical Dental Staff Bylaws or other guidance established by the Governing Body. Credentials will be checked prior to any providers’ delivery of services. All non-licensed staff will be assigned to a mentor for direction and oversight. Each dental program should use a Core Dental Privileging Request Form. Dentists [and hygienists if appropriate] requesting privileges for clinical services must specify categories for which privileges are requested. Full or limited privileges will be granted or denied on the basis of the requesting the provider’s documented training and experience. Documentation of licensure, training and experience in the form of an appropriate training certificate or a letter specifying past experience from the requesting dental provider’s current or immediate past dental supervisor must accompany the Dental Privileges Request Form. [Insert Privileging Application form] 16 A.7 DOCUMENTATION PURPOSE To ensure adequate record keeping for all services provided by the dental clinic. PROCEDURE Dental Record The dental record may be maintained in a hard copy (paper chart) or in an electronic dental record. Regardless of format, the minimal requirements of the dental record are: 1. Medical history 2. Pain documentation 3. Progress notes including all clinical impressions, treatments, medications, procedure codes, and next visit needs 4. Examination and treatment plan form (for comprehensive care) 5. SOAP format (required for Emergency Care) 6. Consultations and referrals if needed 7. Laboratory prescriptions and results if needed 8. Radiographs and documentation that x-rays were read 9. Provider’s signature with credentials (may be an electronic signature for EDR) Documentation At every dental visit the dental provider will update and sign or initial the medical history. Medical history update may be done on the medical history form or in the progress note. All dental services will be documented in ink, contain the date and services provided, and contain the provider’s signature with credentials. Precautions needed for specific physical status will be noted as needed (e.g. appropriate premedication, laboratory test results, or blood pressure recorded for patients with a history of hypertension) Informed consent will be obtained for all routine services. See “Informed Consent” Policy B.13 for a full description of informed consent procedures. Pain Assessment and Documentation Progress notes will indicate the patient’s pain (0-10 scale) at each dental appointment. See Policy A.7 for complete pain assessment and documentation. 17 Emergency Visits The dentist will use the S.O.A.P. format for all emergency visits. 1. SUBJECTIVE S-COMPLAINT, PATEINT’S REPORT OF SYMPTOMS 2. OBJECTIVE O-OBSERVATION OF PROBLEM, RESULTS OF DIAGNOSTIC TESTS 3. ASSESSMENT A-DIAGNOSIS 4. PLAN P-TREATMENT PROVIDED Routine Care A comprehensive examination form will be completed at the initial dental exam, in the event of significant medical or dental changes, or at least every 3 years. The examination form will contain a record of findings in the oral cavity for hard and soft tissues, periodontal screening, temporomandibular joint health, orthodontic status, and documentation that radiographs have been read by the dentist, and radiographic results. A treatment plan based on the results of the examination will be completed. Updates or changes to the treatment plan will be dated and initialed by the dentist as needed. Upon completion of the examination form, the dental provider will explain the findings of the exam to the patient or parent/guardian and obtain informed consent for the proposed treatment plan. 18 A.8 PAIN DOCUMENTATION PURPOSE To establish consistent procedures for assessing and documenting patient’s pain, using an age appropriate assessment tool. PROCEDURE Progress notes will indicate the patient’s pain (0-10 scale) at each dental appointment. If pain is indicated, progress notes will include a description of pain intensity and quality (e.g. location, duration, exacerbating or relieving factors) and management strategies. (See Attached Adult and Pediatric Pain Scale Assessment tools) If a patient’s pain cannot be adequately managed by the treating dentist, the patient will be referred for appropriate assessment and treatment. (See Pain Management Policy #B.16) 19 Adult Pain Assessment Scale 0 No Pain 1 2 Mild Pain 3 4 Moderate Pain 5 6 Severe Pain 7 8 Very Severe Pain 9 10 Worst Possible Pain Pain Assessment Scale Key: 0 = No Pain 1-3 = Mild Pain – MILD PAIN ANNOYING – pain is present but does not limit activity 4-5 = Moderate Pain – NAGGING PAIN, UNCOMFORTABLE, TROUBLESOME – can do most activities with rest periods 6-7 = Severe Pain – MISERABLE, DISTRESSING – unable to do some activities because of pain 8-9 = Very Severe Pain – INTENSE, DREADFUL, HORRIBLE – unable to do most activities because of pain 10 = Worst Possible Pain – WORST PAIN POSSIBLE, UNBEARABLE – unable to do any activities because of pain 20 Pediatric Pain Assessment Scale 0 No Hurt 1 2 Hurts Little Bit 3 4 Hurts Little More 5 6 Hurts Even More 7 8 Hurts Whole Lot 9 10 Hurts Worst Pain Assessment Scale Key: 0 = No Hurt 1-3 = Hurts Little Bit – MILD PAIN ANNOYING – pain is present but does not limit activity 4-5 = Hurts Little More – NAGGING PAIN, UNCOMFORTABLE, TROUBLESOME – can do most activities with rest periods 6-7 = Hurts Even More – MISERABLE, DISTRESSING – unable to do some activities because of pain 8-9 = Hurts Whole Lot – INTENSE, DREADFUL, HORRIBLE – unable to do most activities because of pain 10 = Hurts Worst – WORST PAIN POSSIBLE, UNBEARABLE – unable to do any activities because of pain 21 A.9 MEDICAL RECORDS PURPOSE To ensure confidentiality and patient privacy and prevent loss, tampering and unauthorized access, the [Facility] Medical Records policies will be followed. PROCEDURE Confidentiality All patient information is confidential. Privacy Act and HIPAA training must be completed within 30 days of employment. Documentation of completed training will be placed in each employee’s personnel file. Information not covered under “Routine Uses” in the HIPAA rule can only be copied or removed from the dental file upon signed request from the patient. All information in a patient’s record is subject to HIPAA regulations. Records are not to be left open in patient areas and charts are not to be left in public areas unattended. Schedules with names and procedures will not be left in areas visible to patients. Computer terminals will be situated in such a manner that information cannot be seen by nonstaff. Computer terminals will not be left unattended while the employee is logged on (exception: employee uses computer “lock” function). Data (Hard Copy Charts) All patient visit data must be entered into the dental record by the end of the day of the patient visit. Charts must be monitored or kept in a secure location at all times. All charts must be filed by the end of each day with the exception of charts that are 'pulled' for future appointments. “Pulled” charts must be kept in a secure location. Patient visit data must be entered into the computer system no more than [## days] following the dental visit. Training in Information Management Training for dental documentation will be performed on-site or arranged off site to fulfill requirements for the facility or the department. This training will be documented by [CE coordinator]. 22 A.10 STAFF ASSIGNMENTS AND DUTIES PURPOSE To describe staff requirements necessary to provide quality oral health services. PROCEDURE [Develop your own Staffing requirements] Example: The full time, permanent Dental Clinic staff will consist of two general dentists and five auxiliary personnel. The auxiliary personnel will be composed of one dental assistant supervisor, one dental hygienist, two chair side dental assistants, and one dental receptionist. When available the dental hygienists will schedule patients through the dental receptionist. The hygienists will be responsible for starting new adult patients and seeing referrals from the dentists. New adult patients will be examined and treatment planned by the dentist assigned to exam duty. The hygienists will primarily work unassisted, but may be assigned an assistant depending upon staffing for the day. When available, contract dental personnel shall be assigned to any free operatory. The contract dental personnel shall see specialty dental assignments referred to them by the full time dentists Additional temporary providers, volunteers, and non-permanent employees will be assigned into the clinic schedule to expand services when available. Wednesday mornings no patients will be scheduled. Staff will use this time to attend meetings, stock dental units, complete required documents, or other administrative duties. Duties of the Staff The [Program Director] will develop, coordinate and evaluate the dental program. He/she will be responsible for the authorization, obligation and justification of funds for the contract dental care program. The [Program Director] will be responsible for career development activities of the dental staff under him/her. The [Program Director] will provide dental health services to the designated population according to clinical skills and privileges granted by the facility. The [appropriate staff] is responsible for assigning duties to the dental staff. Staff assignment duties may be delegated to [appropriate staff]. The [appropriate staff] will act as Program Director in the absence of the Director. [Appropriate staff] will serve as the Chairperson of the Dental Health Promotion / Disease Prevention committee. He/she will monitor ongoing HP/DP activities and make recommendations to the [Program Director] regarding clinical and community HP/DP activities. A [appropriate staff] will be responsible for ordering all necessary supplies and maintaining inventory and budget control. A [appropriate staff] will serve as a member on the [appropriate committees or work groups]. Include other staff assigned duties as needed. 23 A.11 STAFF TRAINING PURPOSE Training of employees is an indispensable portion of the function of the clinic. Training ensures that consistent quality procedures are provided in the dental clinic and community. PROCEDURE Training will be used to develop and improve abilities necessary to protect patients, provide high quality dental care, ensure effective programs and promote team cohesiveness to fulfill the mission of the department. Training may be provided through in-services at the facility, external continuing education (CE) courses, online CE courses, agency sponsored conference calls, or other distance learning mechanisms. In-Service This training will be arranged through the [CE coordinator]. This training will be specific and will fulfill specific objectives such as orientation, safety, infection control, Occupational Safety and Health Administration (OSHA) requirements, Privacy Act/HIPAA, hazardous situations, record keeping, and other required topics. Outside presenters will be obtained to provide training for those topics that cannot be provided by this facility. Continuing Education Continuing education (CE) will be provided annually as resources permit. If resources become limited, prioritization will be done by the [Program Director]. Preference for external CE will be given to staff members who must obtain continuing education to maintain licensure and/or certification. Employees are responsible for finding appropriate CE courses, determining if those CE courses fulfill State requirements, and requesting CE through the supervisor. Each licensed or certified dental staff member is responsible for completing adequate continuing education to maintain licensure or certification. Individual staff members are responsible for maintaining documentation of CE courses and reporting CE to the State licensing board as required. Training needs will be determined by employee performance evaluations. Training requests must be submitted to and approved by [appropriate individual]. Each staff will identify long and short term training goals. Training priorities will be set by: 1. Improvement of skills necessary for job performance. 2. New techniques to be used in assigned clinical duties. 3. New clinical duties. 4. Acquiring skills that are identified as needs of the facility or department. 24 A.12 STUDENTS, TRAINEES and VOLUNTEERS PURPOSE The [facility] may utilize students, trainees, and volunteers either in the provision of direct care or in direct support of health care services at the clinic. The purpose of this policy is to outline the guidelines at [facility] for the provision of care for student externs, trainees, and volunteer health care providers. PROCEDURE Each student, trainee, or volunteer (herein referred to as volunteer) who provides direct care at the [facility] shall secure authorization from the [facility] Medical Director prior to providing any direct care on patients. [Insert types of documentation required] shall be furnished at least [time period required for document submission] prior to reporting for work. All volunteers will comply with all [facility] policies and procedures. All volunteers will have a position description that includes qualifications and major duties; other duties may be assigned as appropriate to the position. All volunteers will be given an orientation that includes but is not limited to: Mission and goals of [facility]; HIPAA/Privacy Act; Role and responsibilities of the student/trainee; Employment policies governing volunteers; Clinic eligibility and appointment policies; Clinical policies pertinent to the volunteer’s scope of work; Working hours including lunch and other breaks; Required patient record documentation; Grievance Policy; Relationship of the various clinic departments; Organizational Chain of Command; Location of lunch area, restrooms, Director’s office, etc.; Infection Control and Safety policies. All volunteers will wear an identification badge while on site at [facility], and to return the identification badge [time when badge is to be returned] Example: at the end of the volunteer service, or upon final checkout. Volunteers Providing Direct Patient Care Services All volunteers providing direct care to patients will be introduced to the patient by the supervisor, or his/her designee, as a student/trainee/volunteer. The patient may refuse to be treated by the student/trainee/volunteer. The patient may accept to be treated by the student/trainee/volunteer by signing the Student Volunteer Form (attached). At all times when the student/trainee/volunteer is present, the supervisor is responsible for the provision of care, communication with the patient, and any follow-up care required. 25 If the student is in a formal externship agreement, a Collaboration Agreement or Affiliation Agreement must be signed and approved by the [facility] Clinic Director prior to the student’s arrival. Attach Externship Agreement form(s) 26 DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service PATIENT CONSENT TO TREATMENT BY A VISITING DENTAL OR DENTAL HYGIENE STUDENT Clinical services at IHS dental facilities are sometimes provided by dental or dental hygiene students visiting the clinic. These students are in the process of earning a degree from a dental or dental hygiene school. I have been introduced to ________________________________________________________ (Name of student, plus title: “dental student” or “dental hygiene student”) Visiting from ___________________________________________________________________ (Name of Professional Institution) I understand this student will be providing clinical services for me today. I am aware this student has not yet earned a dental or dental hygiene license. I understand that all services provided by the student will be under the supervision of a licensed dentist or dental hygienist who is at this clinic while the student is treating me. I understand it is my right to stop a procedure at any time if I do not feel comfortable with the student, and I may ask for a second opinion from the supervising licensed dentist or dental hygienist. I understand I have the right to be treated by a licensed dentist or dental hygienist. I understand that I may revoke or withdraw my consent to treatment by this student at any time. I give my permission or consent to be treated by this dental or dental hygiene student. I agree that I have had the chance to ask any questions I have about these arrangements. __________________________________________________ (Signature of Patient) ____________________ (Date) __________________________________________________ (Signature of Legal Guardian, If necessary) ____________________ (Date) __________________________________________________ (Signature of Student) ____________________ (Date) __________________________________________________ (Signature or Supervising Dentist or Dental Hygienist) ____________________ (Date) IHS-950 (9/04) 27 A.13 LEAVE PURPOSE To ensure compliance with [facility] leave policies. PROCEDURE Annual Leave [Follow your Facility’s Personnel Policy for leave] Example: Approval of annual leave for dental personnel will be at the discretion of the supervisor. Annual leave greater than one hour will have to be applied for in advance. Extended annual leave must be applied for and approved in advance of scheduling patients in the clinic. This will usually require a minimum of three weeks notice of intent to take leave. Any employee who reports to work after 8:30 a.m. and has failed to call before 8:30 a.m. may be charged with Absent Without Leave (AWOL). When an employee reports 15 minutes or more late for work it will be charged against their leave record. This may be Annual Leave (AL), Leave Without Pay (LWOP), AWOL or Sick Leave (SL) based upon the circumstances involved in the late reporting. If an employee has not applied for annual leave and requests leave due to an emergency the following procedure will be used: Call the clinic and request the leave over the phone, and when possible: Report to the clinic by 9:00 a.m. and show cause for request of additional leave. If sufficient support staff is present additional leave may be granted. Complete and sign the SF-71 before going on leave. Sick Leave Example All telephone requests for sick leave will be made before 8:30 a.m. All requests for sick leave will be made to your immediate supervisor. The supervisor may request a physician's statement, as deemed appropriate. The physician's statement must be in writing stating the physician has examined the employee and found the employee unable to perform their duties. Sick leave for scheduled appointments must be applied for in advance. If a written physician's statement is requested and is not furnished when the employee returns to work, the employee may be charged with AWOL for the entire leave in question. 28 Absent Without Leave (AWOL) When an employee does not call to request leave or report to the clinic by 8:30 a.m. When a written physician's statement is requested and not furnished. Any time an employee is absent from work without approved leave. Tardiness When an employee reports 5-15 minutes late for work they will be counted as tardy. If an employee is habitually tardy they will be counseled. If after counseling the employee continues to be tardy they will be charged with AWOL. If after two counseling sessions the employee continues to be tardy a letter of reprimand will be issued or corrective disciplinary action will be proposed. Leave Without Pay (LWOP) Leave without pay will be considered on an individual basis within regulatory requirements. 29 A.14 DRESS CODE PURPOSE To ensure all employees are appropriately attired to deliver professional services in a safe and efficient manner. PROCEDURE Chairside dental personnel shall wear a full coverage water impervious gown. The gown must be either discarded daily or cleaned if it is not disposable. Gowns must not be worn outside of patient care areas. Medical scrubs, clean, casual dresses, slacks, shirts, etc. are acceptable; clothing such as jeans, sweatshirts, tank tops are not acceptable when working in patient care areas. Clean, polished shoes, clinical shoes, or athletic shoes are acceptable. At no time may open toed shoes be worn in patient care areas or dental laboratory. Finger nails should be smooth and not interfere with wearing gloves necessary for patient care. Rings or other jewelry must be smooth and not interfere with wearing gloves necessary for patient care. Hair should be clean, groomed and kept neat. [if applicable]Commissioned Officers shall follow all Local Authority Uniform Instructions when not working in patient care areas. 30 A.15 PATIENT SATISFACTION PURPOSE To solicit patient attitudes and level of satisfaction regarding oral health services provided by [facility] PROCEDURE [Frequency] patients will be asked to complete a Patient Satisfaction survey. Describe Process. Example: Patient satisfaction surveys forms will be given to patients who visit the dental clinic in the 1 st week of the April and the 1st week of September. Surveys will be distributed to patients as they check in with the instructions to complete the survey and deposit the form in a box at the reception desk. Attach Patient Satisfaction Form Results Results of the patient satisfaction survey will be communicated to facility administration and to each member of the dental staff and. Areas of poor satisfaction will be addressed in a staff meeting, through continuing education, or other appropriate means. 31 Sample Patient Satisfaction Survey Instructions: Please answer the following questions regarding your MOST RECENT visit to the dental clinic. Date of Visit ________________Provider_________________ Type of Visit (Circle One) Appointment Walk in How satisfied were you with: Length of your dental appointment Scheduling appointments Reminder Cards Staff timeliness Receiving appropriate dental treatment Receiving treatment options Dentist (courteous and professional) Dental hygienist (courteous and professional) Dental Assistant (courteous and professional) Receptionist (courteous and professional) Quality of dental care provided Ability to ask questions Receiving a follow up appointment Confidentiality Referral policy Pain control Overall Dental Care Compliments or Comments: 32 Good Fair Poor Section B: Clinical Services 33 B.1 APPOINTMENT PROCEDURES PURPOSE The purpose of this policy is to create a mechanism of efficient scheduling to ensure timely dental services for eligible recipients. PROCEDURE Definitions BROKEN APPOINTMENT: This is: (1) an appointment that is missed completely, (2) when the patient is more than 15 minutes late by the clinic clock and has not called one full day ahead of the appointment to reschedule. CANCELED APPOINTMENT: This is when a patient is unable to come for a scheduled appointment and phones one day in advance to reschedule their appointment. OPEN ACCESS Patients are seen without an appointment as they present to the clinic ROUTINE PATIENT: This is a patient that has received a scheduled appointment. SHORT CALL LIST: (When necessary based on demand) This is a list of patients who have been treatment planned for routine dental services. Due to the inability of the clinic to meet the demand for patient care in the past, the list will serve as a patient pool and will be called as soon as possible considering clinic demand. If time permits, adults are notified by letter and/or phone for the availability of routine care and given a 15-day period to respond and schedule their appointment. WALK-IN CLINIC: This clinic will care for acute emergencies on a daily basis [hours]. This clinic will also handle some treatment of routine patients. Open Access High risk groups of eligible beneficiaries including [insert current high risk groups such as Head Start children, children age 0-3, diabetes patients] will have Open Access to the dental clinic for preventive services including [insert services such as screening, fluoride varnish, OHI, exams]. Patients seen in Open Access will receive follow up care as needed according to the Patient Appointment procedures. Patients may report to Patient Registration before or after the Open Access visit. 34 Patient Appointments To receive an appointment the patient must first become registered for care at the facility. Patients must meet eligibility requirements as determined by [facility] in order to schedule a routine appointment. The registered patient will be given an appointment for [procedures that may be requested] when requested. Patients with scheduled appointments will report to the dental clinic and sign the dental register. The dental receptionist will check the posted appointment schedule and notify the dental auxiliary that a patient is waiting. When a chair is available a dental auxiliary will seat the patient. Patients reporting more than 15 minutes late for an appointment may have to be rescheduled. To avoid being charged with a broken appointment they may be given the option of waiting until all the other scheduled patients have had their planned treatment completed for that day. The dentist will then determine if enough time permits to provide some dental care for those patients who are waiting. If the patient decides to reschedule his/her appointment after coming in late he/she will be charged with a broken appointment. [This section should be based on a facility policy] Scheduling Priorities Describe priorities for dental appointments Example 1) Emergency dental needs (See Policy B.4) 2) Severe Medically compromised (e.g.,pre-organ transplant, or pre-chemo/radiation therapy) 3) Children 4) Deploying military personnel 5) Students (to accommodate school schedule/breaks) 6) Adults 35 B.2 AFTER HOURS, EMERGENCY DENTAL CARE, and TRIAGE PURPOSE To establish criteria and procedures for emergency dental treatment during and after routine dental clinic hours. PROCEDURE Definition A dental emergency may include but not be limited to one of the following: Severe pain that started within the past 2-3 days Severe pain that keeps the patient awake at night Facial swelling Fever due to an oral infection Excessive bleeding following dental treatment Teeth that have recently been loosened, knocked out or broken due to trauma A facial injury with possible maxillary or mandibular fracture. Intake Procedures (Describe procedures followed for emergency patient intake and processing) Example: Clinics with On Call Dentists When emergency patients call or present for treatment, medical or dental staff may use the triage questions listed above to determine if the patient can wait to be seen in the dental clinic or should be immediately referred to the Emergency Room. Patients to be seen in the dental clinic will sign the dental register at the reception window. Emergency care referrals will be made to the dental clinic by the Ambulatory Care clinics. These referrals will be presented by the use of a referral form during regular working hours. After regularly scheduled hours, verbal instructions will be taken by the dentist on call in order to assess patient needs. This dental provider will speak directly to the medical provider to ascertain the nature of the complaint. Appropriate transfer of the patient to dental referral services or delivery of dental care service will be determined by the dentist on call. Example: Clinics without On Call Dentists When emergency patients call or present for treatment, medical or dental staff may use the triage questions listed above to determine if the patient can wait to be seen in the dental clinic or should be immediately referred to the Emergency Room. Patients to be seen in the dental clinic will sign the dental register at the reception window. Emergency care referrals will be made to the dental clinic by the Ambulatory Care clinics. These referrals will be presented by the use of a referral form during regular working hours. After regularly scheduled hours, patients should report to the Emergency Room for assessment and emergency care based on the Triage Protocols. Appropriate transfer of the patient to dental referral services or [Facility] dental clinic during routine clinic hours will be determined by the attending physician. 36 Scheduling Emergency patients will be treated on a time available basis. Emergency patients will receive treatment the day they report to the clinic with their chief complaint, schedule permitting. The patient will be given medication for relief of pain and/or infection and rescheduled or referred if treatment cannot be rendered that day. Emergency patients will be seen in the Dental Clinic [hours]. Patients with dental emergencies after normal clinic hours will report to [appropriate location]. 37 Dental Triage Guide Medical or dental staff may triage patients to determine dental emergency needs and necessary immediate interventions. If patients call with an oral health complaint, the following triage protocol is suggested. Complaint Suggested Therapy Patient Disposition/Follow up Severe pain that started within the past 2-3 days Pain medication Emergency Dental Clinic or next available scheduled appointment Severe pain that keeps the patient awake at night Pain medication Emergency Dental Clinic or next available scheduled appointment Facial swelling (mild), w/o fever, no airway restriction Pain medication and antibiotics Emergency Dental Clinic or next available scheduled appointment Facial swelling(moderate-severe) w/ fever, no airway restriction Pain medication and antibiotics Emergency Dental Clinic (same day) or ER Airway sequelae (e.g.,unable to open mouth, and/or can’t stick out tongue, and/or sublingual swelling, and/or uvula deviation If Dentist available immediate dental evaluation. If no Dentist available, ER referral Immediate dental or ER evaluation Any airway restriction Immediate evaluation and treatment Immediate emergency care Oral bleeding If Dentist available immediate dental evaluation. If no Dentist available, ER referral Immediate dental or ER evaluation and treatment Trauma that leads to (e.g.,loose, broken, or avulsed teeth, or where facial fractures are suspected) If tooth knocked out, place tooth in milk (if possible) then ER referral for C spine/neurological clearance ER. After cleared by a physician, have the patient follow up with the dental clinic (Catawba Dental Clinic, Dr. Jeffrey Stuart, 2008) 38 B.3 ON CALL (include this policy only if your facility has an active “On Call” program. For those clinics without an “On Call” program, See Policy B.2 “After Hours, Emergency Care, and Triage”) PURPOSE: To provide for consultative services in the event of dental emergencies at the [Facility] during the hours that the dental clinic is closed. POLICY: The Dental Program shall have one Dentist in “on call” status at all times. The “on call” dentist will be available by cell phone at all times for the purposes of providing verbal consultation in regards to dentally related matters to other [Facility] professional staff members. PROCEDURES: (Describe Dental Call schedule and procedures) Example: 1. All dentists working within the [Facility] Dental Department are required to rotate pulling dental call for one week at a time. To ensure fairness, there will be a separate rotation for the 10 annual Federal Holidays. If a dentist has a conflict and cannot pull call for a week that they are scheduled to be on call, it is their responsibility to find another dentist to trade call weeks with. Such trades must be appropriately recorded on the call schedule and both dentists must agree to the trade. 2. The Deputy Chief of the Dental Program will have the responsibility of preparing and updating the dental call schedule. 3. Dental call will start at 8:00am on each Wednesday and end at 8:00am the following Wednesday. 4. The dentist on call should be available at all times by cell phone. Given that travel within the region, including to and from available housing, will often take dentists through areas without cell phone coverage, it is essential that dentists on call check their cell phone messages on a frequent and recurring basis. Any messages from the [Facility] in regards to a dental emergency must be returned as soon as possible. 5. Because the standard of care is often difficult or impossible to meet without a trained dental assistant and there are no dental assistants available after-hours, on call dentists are only available for phone consultation. The vast majority of general dental emergencies are easily treated with antibiotics and/or analgesics until the dental clinic opens the following day. Cases involving facial fractures or severe life threatening swellings or infections are beyond the scope of general dentists and should be referred directly to an oral surgeon. 6. A dental emergency kit is kept in the Emergency Room for use by the ER staff. On each Wednesday, the new on call dentist is responsible for: a. Restocking the ER’s dental emergency kit. b. Advising the ER staff that they are on call and giving them the appropriate contact information the ER staff will need in order to contact them in a timely manner. 39 B.4 GUIDELINES for PRENATAL ORAL HEALTH CARE PURPOSE To establish guidelines for the treatment and prevention of oral diseases during pregnancy and to promote the overall oral health of women and infants. PROCEDURE This facility adheres to the National Maternal and Child Oral Health Resource Center guidelines for treatment during pregnancy. Recommendations of the NMCOHRD’s 2008 guidelines include: General Dental Health Services: Oral hygiene and oral health during pregnancy is important to overall health of the mother and fetus Oral health care during pregnancy is safe and effective and is essential for the pregnant woman and the fetus Diagnosis (including necessary dental X-rays) and treatment for conditions requiring immediate attention are safe during the first trimester of pregnancy Necessary treatment can be provided throughout pregnancy; however the period between the 14th and 20th week of pregnancy is the best time to provide treatment Delaying necessary treatment could result in significant risk to the mother and indirectly to the fetus Dental provider will consult with the prenatal care Heath Professional in cases of: Deferring treatment because of pregnancy Co-morbid conditions or medication use (e.g. diabetes, hypertension, heparin use) that may affect management of oral problems Intravenous sedation or general anesthesia to complete dental procedures 40 B.5 INTOXICATED PERSONS PURPOSE To provide a protocol for the treatment of intoxicated persons who present themselves to the dental clinic requesting care. This policy is necessary for the following reasons: 1. Intoxicated patients are often unable to remember or to follow post-operative instructions. 2. Intoxicated patients are more likely to become nauseated during or after dental treatment. 3. Intoxicated patients cannot give adequate medical histories. 4. Intoxicated patients cannot be given appropriate pain medications due to the possible interactions between the pain medication and the intoxicating substance. 5. Intoxicated patients may become abusive, unmanageable and violent while receiving treatment. PROCEDURE Intoxicated individuals will not be treated in the dental clinic, except in cases of life threatening emergencies. If a patient, in the judgment of the treating dental provider, is under the influence of alcohol or other intoxicating substances, he/she will be asked to leave the clinic and return when no longer impaired for care. Security will be called to remove the intoxicated patient if he should become belligerent or abusive. Other dental staff such as receptionists who observe behavior believed to be caused by alcohol or other intoxicating substances will alert the dental provider who will then make the decision to treat the patient or defer treatment until the patient is no longer impaired. Patients who repeatedly present to the dental clinic in an intoxicated state will be referred to their medical provider or appropriate behavioral health program. 41 B.6 STANDING ORDERS FOR DENTAL AUXILIARY STAFF PURPOSE To establish authorization for dental auxiliary personnel to provide dental procedures allowed under the [State dental practice act or IHS regulations]. PROCEDURE Dental Receptionist The dental receptionist or dental staff member who checks patients or parent/guardian in for dental treatment will give all new patients and emergency patients a Dental Health History Form to complete. The dental staff member who seats the patient will check the form for completeness and help the patient complete the form if needed. Dental Assistants Dental assistants trained to take blood pressures will take and record in the patient’s health record blood pressures on all new patients 30 years old and older with a history of hypertension. This will be done on the patient's first visit of the year and on emergency patients 30 years old or older at each emergency visit if a reading taken within 30 days cannot be found in the patient’s medical or dental record. Dental assistants trained and certified in dental radiography shall take a periapical x-ray in the area of the chief complaint for emergency patients. The dentist shall be consulted in the case of "loose", exfoliating primary teeth prior to taking a periapical radiograph. Dental assistants who perform direct services for patients (e.g. oral hygiene instructions, patient counseling for tobacco cessation, sealants, fluoride treatments, etc.) shall have the charts reviewed and signed by the supervising dentists. Dental Hygienists Initial Treatment Dental hygienists will follow treatment plans determined at the initial exam and perform all services allowed by [IHS guidelines for sites following IHS guidelines, or State Practice acts for tribal sites.] [For States or IHS sites allowing unsupervised dental hygiene services or assessments, insert allowed services and procedures here.] Hygienists may assess for and place sealants on pits and fissures on teeth that have not been treatment planned for restoration. OR Hygienists may review medical history and provide appropriate basic preventive services including prophylaxis, fluoride treatments, and determine the need for and place sealants prior to a comprehensive dental examination. Recall The dental hygienist may determine the patient’s risk category and establish an appropriate recall schedule. For patients of record, X-rays and clinical services will be provided without a reassessment by a dentist. (See Radiography Policy B.14. for radiography frequency guidelines) Upon completion of treatment, dental hygienists will complete the patient record and sign the chart with name and credentials. No co-signature is needed for services provided by a dental hygienist. 42 B.7 MEDICAL HISTORY PURPOSE To ensure that appropriate precautions are provided according to each patient’s physical status as determined by medical history, physician’s recommendations, and/or risk factors. PROCEDURE All patients presenting to the Facility Dental Clinic will be given a medical history to complete. New patients or those patients that have not been seen in the past 12 months will be required to complete and sign and date this form. A new form must be completed at least every 24 months. As the patient enters the clinic, the receptionists will give them a blank form and instructions for completing the form. If the individual completing the form is unable to complete the form because of the nature of the question, they are instructed to leave it blank to be filled in on interview with the dental provider. Family members or staff members may assist patients with literacy, language or sight issues who cannot read or understand the form. The patient’s or parent/guardian signature on the Medical History form indicates that all statements are true and gives consent for the dental provider to initiate screening, examination and diagnostic services. Informed consent including a full discussion of treatment needs, risks, benefits and alternative treatments will be obtained following the completion of the examination form. (See Informed Consent Policy B.13) When the patient is seated in the dental operatory, the dental assistant and later the dental provider will interview the individual or their guardian as to the questions on the form. If there is inadequate information to determine appropriate precautions for dental treatment based on the responses or if there is a discrepancy in the replies to the dental provider’s questions, further investigation is initiated. If necessary the medical chart is obtained. If the dental provider is still unable to answer the question to his/her satisfaction, the patient will be referred to the [appropriate clinic or referral site] with a completed referral form indicating the specific medical evaluation request. The examination by the medical provider is followed by a routing of the results via [appropriate mechanism] or verbal consult with the dental provider to answer to the initial question. Dental procedures will not be initiated until there are no questions remaining in the health history. If medical alerts are found, precautions for those alerts are determined and initiated. These alerts and/or precautions are noted on the bottom of the Examination Form and a medical caution sticker is placed on the front of the individual's dental chart. Notation will also be made to print a current Health Summary at each dental visit. Patients for subsequent visits to the dental clinic, within one year of the initial completion of the medical history, are asked if there is any change in their health statues. The dental provider initials the form in the proper location. For EDR clinics: Completed and signed medical history forms are scanned into the Electronic Dental Record. [Delete this paragraph if not applicable] 43 Sedation patient's medical histories are examined prior to the suggestion or scheduling the individual for dental procedures. If there is any question, the patient is sent to the out patient clinic for examination and clearance. For these individuals, a pre-sedation appraisal of their health is determined. (See Sedation Policy B.25 for a full description of required documentation) 44 B.8 SCHEDULE OF SERVICES PURPOSE In order to provide dental services of the highest quality to the most people with the resources available to the Facility Dental Program, priorities must be established. The purpose of these priorities is to maximize the benefits of dental care to as many eligible patients as possible. This facility adheres to the IHS guidelines for service priorities. In accordance with the IHS’s 2007 Oral Health Program Guide, the following is a summary of available dental services in order of highest priority to lowest priority for the Facility, with examples of common services in each level. PROCEDURE Dental Service Priorities Schedule of Services (IHS Oral Health Guide: Section V) Level I — Emergency Care Includes those dental services which are necessary to relieve or control acute oral conditions, such as: serious bleeding, a potentially life-threatening difficulty, maxillo-facial fractures, and swelling and severe pain, or other signs of infection. Other conditions which the patient may determine to require urgent attention are also classified as Level I care (e.g., prosthodontic repairs). Procedures which are frequently reported in this category of care are listed below: • Emergency oral examination (limited to problem area) • One or more periapical radiographs associated with the problem • Simple tooth extractions • Temporary or sedative restorations • Palliative procedures • Prescription medications for pain and infection • Endodontic access preparations • Draining of oral abscesses • Denture repairs and other urgent repairs Level II — Primary (Preventive) Dental Care The procedures classified as primary care are those which prevent the onset of oral disease. Clinical services to individual patients and community health activities are included in Level II care. The primary care services most frequently provided are: • Adult prophylaxis with or w/o topical fluoride • Child prophylaxis with or w/o topical fluoride 45 • • • • • • • Sealants by tooth or quadrant Preventive (self-care) training Periodontal recall procedures Athletic mouthguards Water fluoridation activities Group education Tracking of number of children receiving supplemental fluorides per month Level III — Secondary Dental Care Level III services are those deemed necessary for routine diagnosis and treatment to control the early stages of disease. Level III procedures are generally not complicated in nature, and one or more of these services can usually be completed in one appointment. The Level III procedures commonly reported include the following: • Initial or periodic oral exam • Bitewing and panoramic radiographs • Diagnostic casts • Space maintainers • Amalgam restorations (1,2,3-surface) • Composite restorations (1,2,3-surface) • Stainless steel crowns (primary teeth only) • Therapeutic pulpotomy (primary teeth only) • Anterior endodontics (one canal) • Periodontal scaling/root planing • Biopsy, excision of lesion Level IV — Limited Rehabilitation Rehabilitative care is that which restores oral structures to an improved condition and form. Limited rehabilitation is defined by the IHS as those dental procedures which are more complex and costly to provide than Level III care in controlling disease and restoring function. The following Level IV services are those most frequently utilized: • Complex amalgams (4 or more surfaces) • Cast onlays or crowns with or w/o porcelain • Post and core restoration • Crown buildups • Acid etch (Maryland) bridge • Bicuspid endodontics (two canals) • Apicoectomy/retrograde filling • Gingivoplasty 46 • Limited/interceptive orthodontics Level V — Rehabilitation The dental services classified into this level are rehabilitative procedures which require more clinical chairtime, additional knowledge and skill of the care provider, and usually greater expense than the limited rehabilitative services listed under Level IV care. Level V services usually require multiple appointments to complete, are usually associated with a rehabilitative plan for the entire mouth, and generally require a substantial patient copayment to cover professional fees in dental insurance and other third party programs. The Level V services most frequently provided are: • Molar endodontics (3 or more canals) • Periodontal surgery (mucogingival and osseous) • Complete and partial dentures • Denture rebase (laboratory) • Fixed bridgework (retainers and pontics) • Surgical extractions (impactions) • Analgesia (e.g., nitrous oxide) Level VI — Complex Rehabilitation Level VI includes those services which usually require more time, skill, and cost than the rehabilitative procedures classified under Levels IV and V. A substantial portion of patients may require referral to specialists for complex rehabilitative treatment; however, referrals must be justified by special circumstances which warrant the associated higher costs. Level VI services may not predictably improve the overall prognosis of many patients. Thus, careful patient selection is a critical factor in the provision of Level VI care. Complex rehabilitation includes the following procedures: • Cephalometric or TMJ radiographs • Occlusal adjustment (complete) • Periodontal surgery – osseous or soft tissue grafts – repositioned flaps • Overdentures • Consultation for speciality services • Precision attachment prosthetics • Comprehensive orthodontics (Class I, II, or III) – case analysis & work-up – fixed appliances (usually full-banding) – orthodontic care follow-up visits – post-treatment stabilization • Surgical extractions (bony impactions) and unusual or complex oral surgery 47 • • Maxillo-facial prosthetics Intravenous (IV) sedation, general anesthesia Level X — Exclusions Level X comprises those services which are not classified as billable procedures in programs serving American Indians/Alaska Natives. Excluded services have one or more of the following characteristics, as determined by the Indian Health Service: • A highly variable rate of success • Difficult to monitor in terms of appropriateness or effectiveness • Not universally defined or accepted for reporting purposes • Included as part of other reportable services (thus they need not be reported separately) • Involve the use of materials or techniques which are obsolete or which may not be the most cost-beneficial • Codes used only for management purposes on an optional basis (e.g. broken appointments, non-clinical administrative activity) The following procedures are examples of exclusions which are frequently reported: • Caries susceptibility tests • Oral hygiene instruction (included in prophylaxis) • Removable unilateral space maintainers • Silicate restorations • Gold foil restorations • Cast inlay (2-surface) • Porcelain inlays or crowns • Full resin or resin/metal crowns • Direct pulp caps • Endodontic implants, hemisection • Gingival curettage • Coronal splinting • Unilateral cast partials • Chairside denture relines • Alveolar/mandibular implants • Prosthetic stress breakers 48 • • • • • • Tooth implant/transplant Myo-functional therapy Pulpotomy in permanent tooth Odontoplasty Behavior management Broken appointments 49 B.9 COMPLETED TREATMENT PURPOSE To establish a mechanism to ensure continuity of care for all dental patient who receive a comprehensive examination. PROCEDURE At the time a patient receives a comprehensive examination/[or initial assessment by a dental hygienist (if following IHS standards or permitted by the State practice Act)] a treatment plan is written by the dental provider. This treatment plan will list the procedures that will be done for that patient. These procedures will be based upon established priorities, the dental provider’s skills and available time and resources. [For dental clinics using RPMS or the IHS EDR] When the initial treatment plan is completed, a code of 9990 will be entered into the RPMS system. After scheduled treatment is completed, it is the patient’s responsibility to contact the dental clinic if further dental services are required. OR When all services in Level I-III have been completed, a code of 9990 will be entered in the dental record. (IHS recommendation) After scheduled treatment is completed, it is the patient’s responsibility to contact the dental clinic if further dental services are required. A dentist or hygienist may recall a patient as frequently as he/she feels it is necessary to maintain oral health. 50 B.10 REFERRAL PROCEDURES PURPOSE To establish a procedure for referrals for oral health services for eligible recipients. PROCEDURE Intra-Facility Referrals Emergency Patients Referred to Dental [Insert facility procedures] Sample: Regular Working Hours: Emergency patients are referred to the dental clinic during regular work hours from any medical care department or school-nursing department using a PCC or facility referral. This referral can come from Out-Patient Clinics, Community Health Nursing, WIC, or MCH. After Hours: Patients who are experiencing severe pain may go to an emergency room or dental treatment facility, but must notify the Facility’s CHS office immediately or at least within 72 hours from time of treatment. Only emergency treatment services should be provided by an emergency room or dental treatment facility. Routine Patients Referred to Dental These patients can be self referred or referred in the same manner as above. The patient may present to the dental receptionist with an "in-house" referral form or verbally request that an exam appointment be made. All Patients Referred from Dental All patient referrals made from the dental clinic to any department in the hospital are made using a PCC form. All demographic coding, dental subjective and objective findings must be completed. Inter-Facility Referrals (For programs with multiple dental clinics) Emergency Patients Referred to Dental These patients can receive care as above. They can also self refer. Routine Patients Referred to Dental These patients can receive an appointment for routine care via self-referral, telephone request, written request or as described above. All Patients Referred from Dental The dental records of that patient will accompany all patient referrals made from the dental clinic to another facility. HIPAA regulations that govern transfer of information within the facility network will be followed for information transfer. 51 Referrals to External Providers [This needs to be established by Facility Management and CHS Office] All Patients Referred from Dental to External Providers These patients must have a referral initiated, for work covered under the Facility’s Contract Health Guidelines, that includes the reason for referral, estimated cost, priority and third party eligibility entered on the form. The patient takes the form to Contract Health so that a contract can be written. Endodontics, Oral Surgery and Pedodontic services done by an external provider must have a referral for services to be provided. The [Dental Program Director] must first authorize emergency visits to external providers so that Contract Health Guidelines are met. To external provider: The dentist completes an HSA-199 listing the procedure(s) needed. The completed form is then given to the dental receptionist. Referrals will be made to contract providers. The [appropriate dental staff] calls the external provider and schedules an appointment. The [appropriate dental staff] completes the HSA-199 and forwards the original to the Contract Health Services (CHS) clerk, placing one copy in the patient's record. The CHS clerk will complete the HRSA 57 form and mail it and one copy of the referral form (HSA-199) to the external provider. Use of Contract Health Funds The Facility CHS Office will be responsible for the allocation of Dental CHS funds. When obligating these funds the following policies will be used: Revise as needed to comply with CHS policies. The patient must be registered for care at the facility to be eligible for contract funds. Contract money may be used to pay for laboratory services. Contract money will be used based on the Facility’s priorities for contract dental services. Contract money will not be used to provide orthodontic treatment. Contract funds will not be used to provide surgical TMJ "treatments" or care. 52 B.11 DENTAL LABORATORIES PURPOSE To establish procedures for using external dental laboratories and to establish guidelines for laboratory fees to be paid. PROCEDURE Use of Dental Laboratories Dental laboratories are used to fabricate dental appliances that cannot be fabricated in the Facility Dental Clinic. These appliances require a laboratory prescription and all cases must adhere to infection control policy and procedure, HIPAA requirements, and contract health guidelines. Because the dental laboratory is involved with the care of the patient, no HIPAA Business Associate Agreement is required. It is the responsibility of the dental laboratory to maintain confidentiality while the case in the laboratory and during shipment to the dental facility. Dental Laboratory Fees Laboratory cases are cleared prior to scheduling by the [appropriate individual] in charge of Contract Health. This will determine the correct resources prior to initiating treatment. The patient or parent/guardian is responsible for all dental laboratory costs. Lab fees vary. An estimate will be given to the patient or parent/guardian at the examination appointment or at the time the need for the service is determined. This is an estimate only; patients will be responsible for unforeseen laboratory charges. The estimated fee must be paid in advance by certified check or money order made out to the dental lab performing the service. Fees must be paid on or before the day of the dental appointment. If you arrive for your dental appointment and the lab fee has not been paid, the patient’s appointment will be rescheduled to allow more time to pay the fee. Lab fees are ONLY refundable before the case is sent to the lab. If the patient does not keep the appointment for the delivery of the device the lab fee will not be refunded. If the device must be remade, the patient is responsible for paying the additional laboratory fee. 53 Sample Handout to Patients Dental Laboratory Fees Your treatment includes work that must be completed at a dental laboratory. Because [Health Center Name] must pay the dental laboratory for this service, lab fees are not a covered benefit. If you would like to have this treatment completed, you must pay the laboratory fee. This only applies to services done at an external dental laboratory. Payment of dental laboratory fees will be made according to the following procedures. 1. The patient or parent/guardian is responsible for all dental laboratory costs. Lab fees vary. An estimate will be given to you at the examination appointment or at the time the need for the service is determined. This is an estimate only; patients will be responsible for unforeseen laboratory charges. 2. The estimated fee must be paid in advance by certified check or money order made out to the dental lab listed below. Fees must be paid on or before the day of the dental appointment. If you arrive for your dental appointment and the lab fee has not been paid, we will be happy to reschedule your appointment to allow you more time to pay the fee. 3. Lab fees are ONLY refundable before the case is sent to the lab. If you do not keep your appointment for the delivery of the device your lab fee will not be refunded. If you need to have the device remade you will have to pay another lab fee. _______________ Patient _________________ Chart Number __________ Date __________________________________________ __________________________ Procedure(s) Lab Fee Estimate ______________________________________________________ Dental Laboratory I have read and understand the above policy. I agree to pay the estimated lab fees before any dental treatment requiring laboratory work is done. _________________________________ Patient or Parent/Guardian Signature _______________________ Date _________________________________ Dentist Signature _______________________ Date 54 B.12 PROTECTIVE STABILIZATION PURPOSE To establish procedures for the safe protective stabilization of patients during dental treatment. PROCEDURE This facility adheres to the American Academy of Pediatrics Dentistry’s’ (AAPD) guidelines for protective stabilization. The policy will apply to all patients, regardless of age. According to the AAPD’s 2006 Guideline for Behavior Guidance for the Pediatric Dental Patient: The following is a statement by the American Academy of Pediatric Dentistry. Revise as needed for your facility. “The use of any protective stabilization in the treatment of infants, children, adolescents, or persons with special health care needs is a topic that concerns health care providers, care givers, and the public. The broad definition of protective stabilization is restriction of patient’s freedom of movement, with or without the patient’s permission, to decrease risk of injury while allowing safe completion of treatment. The restriction may involve another human(s), a patient stabilization device, or a combination thereof. The use of protective stabilization has the potential to produce serious consequences, such as physical or psychological harm, loss of dignity, violation of a patient’s rights, and even death. Because of the associated risks and possible consequences of use, the dentist is encouraged to evaluate thoroughly its use on each patient and possible alternatives. Partial or complete stabilization of the patient sometimes is necessary to protect the patient, practitioner, staff, or the parent from injury while providing dental care. Protective stabilization can be performed by the dentist, staff, or parent without the aid of restrictive device. The dentist should always use the least restrictive, but safe and effective, protective stabilization. The use of a mouthprop in a compliant patient is not considered protective stabilization. The need to diagnose, treat, and protect the safety of patient, practitioner, staff, and parent should be considered for the use of protective stabilization. The decision to use protective stabilization should take into consideration: 1. alternative behavior guidance modalities; 2. dental needs of the patient; 3. the effect on the quality of dental care; 4. the patient’s emotional development; 5. and the patient’s physical considerations. Protective stabilization, with or without a restrictive device, performed by the dental team requires informed consent from a parent. Informed consent must be obtained and documented in the patient’s record prior to the use of protective stabilization. Due to the possible aversive nature of the technique, informed consent should also be obtained prior to a parent’s performing protective stabilization during dental procedures. Furthermore, when appropriate, an explanation to the patient regarding the need for restraint, with an opportunity for the patient to respond, should occur. In the event of unanticipated reaction to dental treatment, it is incumbent upon the practitioner to protect the patient and staff from harm. Following immediate intervention to assure safety, if techniques must be altered to continue delivery of care, the dentist must have informed consent for the alternative methods. The patient’s record must include: 1. informed consent for stabilization; 55 2. 3. 4. 5. 6. indication for stabilization; type of stabilization; the duration of application of stabilization; frequency of stabilization evaluation and safety adjustments; behavior/evaluation rating during stabilization. Objectives: The objectives of patient stabilization are to: 1. reduce or eliminate untoward movement; 2. protect patient, staff, dentist, or parent from injury; 3. facilitate delivery of quality dental treatment. Indications: Patient stabilization is indicated when: 1. patients require immediate diagnosis and/or limited treatment and cannot cooperate due to lack of maturity; 2. patients requires immediate diagnosis and/or limited treatment and cannot cooperate due to mental or physical disability; 3. the safety of the patient, staff, dentist, or parent would be at risk without the use of protective stabilization; 4. sedated patients require limited stabilization to help reduce untoward movement. Contraindications: Patient stabilization is contraindicated for: 1. cooperative nonsedated patients; 2. patients who cannot be immobilized safely due to associated medical or physical conditions; 3. patients who have experienced previous physical or psychological trauma from protective stabilization (unless no other alternatives are available); 4. nonsedated patients with nonemergent treatment requiring lengthy appointments. Precautions: The following precautions should be taken prior to patient stabilization: 1. tightness and duration of the stabilization must be monitored and reassessed at regular intervals; 2. stabilization around extremities or the chest must not actively restrict circulation or respiration; 3. stabilization should be terminated as soon as possible in a patient who is experiencing severe stress or hysterics to prevent possible physical or psychological trauma. “ 56 B.13 CARIES STABILIZATION PURPOSE According to the American Academy of Pediatric Dentistry and endorsed by the Indian Health Service, caries stabilization using an Interim Therapeutic Restoration is an effective means of treating small carious lesions. Frequently these restorations remain in primary teeth until exfoliation. “The American Academy of Pediatric Dentistry (AAPD) recognizes that unique clinical circumstances can result in challenges in restorative care for infants, children, adolescents, and persons with special health care needs. When circumstances do not permit traditional cavity preparation and/or placement of traditional dental restorations or when caries control is necessary prior to placement of definitive restorations, interim therapeutic restorations (ITR)1 may be beneficial and are best utilized as part of comprehensive care in the dental home… The AAPD recognizes ITR as a beneficial provisional technique in contemporary pediatric restorative dentistry. ITR may be used to restore and prevent dental caries in young patients, uncooperative patients, patients with special health care needs, and situations in which traditional cavity preparation and/or placement of traditional dental restorations are not feasible. ITR may be used for caries control in children with multiple carious lesions prior to definitive restoration of the teeth.” (AAPD, 2008, available online at: http://www.aapd.org/media/Policies_Guidelines/P_ITR.pdf ) PROCEDURE: Goal of Interim Therapeutic Restorations To provide treatment without local anesthetic using fluoride-releasing glass ionomer on teeth diagnosed with neither necrotic nor irreversible pulpitis. This procedure can be done by general dentists and their staff, often avoiding dental treatment under general anesthesia. (IHS, 2012. Available online at: http://www.ihs.gov/doh/documents/ecc/NewECCPacket/Fillings.pdf ) Indications Interim Therapeutic Restorations are indicated for infants, children, adolescents and children with special health care needs when conventional restorative care is not available or needs to be deferred. (IHS, 2012) Placement and Follow Up The ITR procedure involves removal of caries using hand or slow speed rotary instruments with caution not to expose the pulp. Leakage of the restoration can be minimized with maximum caries removal from the periphery of the lesion. Following preparation, the tooth is restored with an adhesive restorative material such as self-setting or resin-modified glass ionomer cement.11 ITR has the greatest success when applied to single surface or small 2 surface restorations.12,13 Inadequate cavity preparation with subsequent lack of retention and insuf12 ficient bulk can lead to failure. Follow-up care with topical fluorides and oral hygiene instruction may improve the treatment outcome in high caries-risk dental populations. (AAPD, 2008) 57 B.14 INFORMED CONSENT PURPOSE According to the American Dental Association, “A consent form is a document that a patient has knowingly consented to a particular treatment. The key is the discussion between the dentist and the patient during which the treatment, its risks and benefits and alternatives, are all discussed. An informed consent form is evidence this discussion took place. It should be signed and dated by the patient.” The purpose of this policy is to identify procedures that require informed consent and to establish procedures for obtaining and documenting informed consent. PROCEDURE Following a comprehensive examination, the dentist will develop a proposed treatment plan. The dentist will explain the proposed treatment, risks and benefits of treatment, and consequences of non-treatment. The patient or parent/guardian will have the opportunity to ask questions about the proposed treatment. Slight and/or unanticipated protective stabilization may be included in the treatment plan. The patient’s (parent/guardian) signature on the treatment plan form will indicate informed consent for proposed routine treatment. A separate Informed consent form will be used for cases of: (List Procedures) IHS recommends consent forms for: Tooth extraction Invasive surgical intervention Endodontics Protective stabilization (with or without restrictive device) Nitrous oxide analgesia/anxiolysis Conscious sedation Complex pediatric cases (see following section) Use of extracted teeth or soft tissues to be used for educational or research purposes Any procedure requiring the need for specific informed consent will use the [form name or number] This form will be explained to the patient by the provider or dental assistant and signed by patient or parent/guardian, provider and a witness. Treatment of Minors Informed consent for dental treatment will be obtained in writing from all patients (18 years and older) or from the parent or legal guardian of a minor. In the case of a minor who is not accompanied by a parent or legal guardian, emergency care to treat bleeding, extreme pain, prevent the spread of infection or other severe conditions will be accomplished with minimal medical and/or surgical intervention required to stabilize the patient and prevent permanent 58 injury until legal written consent can be obtained. The forms will be kept in the patient’s dental chart. INSERT Appropriate Forms (Informed consent MUST INCLUDE benefits, risks, and alternatives) 59 B.15 RADIOGRAPHY PURPOSE To set general guidelines for prescribing dental radiographs. PROCEUDRE General Procedures 1. All dental radiographs will be taken using appropriate lead aprons with cervical collars. 2. Non-licensed staff taking radiographs will have documentation of appropriate Radiology training as required by [insert State or IHS]. Type and Frequency of Radiographs The following radiograph recommendations are consistent with the American Dental Association (ADA) 2004 guidelines for dental radiographic examinations. See http://www.ada.org/sections/professionalResources/pdfs/topics_radiography_examinations.pdf for the full ADA Guidelines for Prescribing Dental Radiographs document. 60 The recommendations are subject to clinical judgment and may not apply to every patient. Patient Age and Developmental Stage Type of Encounter Children with Primary Dentition (prior to the eruption of the 1st permanent tooth) Child with Transitional Dentition Adolescent Dentition (prior to the eruption of 3rd molars) New Patient* being evaluated for dental disease and/or dental development 1. Selected occlusal or periapical films 1. Panoramic film 1. Panoramic film Recall* with clinical caries or increased risk of caries** 1. Posterior bitewings at 6-12 month interval Recall with no clinical caries and not at increased risk for caries** 1. Posterior bitewings at 12-36 month intervals 2. Posterior bitewings 2. Posterior bitewings Adult Dentate or Partially Edentulous 2. Posterior bitewings as needed 3. Selected periapical films Edentulous Adult Individual exam based on clinical signs and symptoms 3. Selected periapical 2. Selected periapical films as needed 2. Selected periapical films as needed 61 Not applicable Not applicable Patient Age and Developmental Stage Type of Encounter Children Child with with Primary Transitional Dentition Dentition (prior to the eruption of the 1st permanent tooth) Adolescent Dentition (prior to the eruption of 3rd molars) Recall* with periodontal disease Clinical judgment as to the need for and type of radiographic images for the evaluation of periodontal disease. Not applicable Patient for monitoring growth and development Clinical judgment as to the type and need of radiographic images to monitor growth and development. Not applicable Patients with other circumstances Clinical judgment as to the type and need of radiographic images for evaluating and/or monitoring specific patient circumstances. Clinical judgment as to the type and need of radiographic images to monitor growth and development. Panoramic or periapical exam to assess development of third molars. Adult Dentate or Partially Edentulous Usually not indicated Edentulous Adult Note: A new patient is an individual who is new to the facility, has not received regular dental care, has had significant changes in medical or dental history, or has not received any dental services in the facility for a significant period of time. *Clinical situations for which radiographs may be indicated include but are not limited to: A. Positive Historical Findings 1. Previous periodontal or endodontic treatment 2. History of pain or trauma 3. Familial history of dental anomalies 4. Postoperative evaluation of healing 62 5. Remineralization monitoring 6. Presence of implants B. Positive Clinical Signs and Symptoms 1. Clinical evidence of periodontal disease 2. Large or deep restorations 3. Deep carious lesions 4. Malposed or clinically impacted teeth 5. Swelling 6. Evidence of dental/facial trauma 7. Mobility of teeth 8. Sinus tract (“fistula”) 9. Clinically suspected sinus pathology 10. Growth abnormalities 11. Oral involvement in known or suspected systemic disease 12. Positive neurologic findings in the head and neck 13. Evidence of foreign objects 14. Pain and/or dysfunction of the tempopomandibular joint 15. Facial asymmetry 16. Abutment for fixed or removable partial prosthesis 17. Unexplained bleeding 18. Unexplained sensitivity of teeth 19. Unusual eruption, spacing, or migration of teeth 20. Unusual morphology, calcification or color 21. Unexplained absence of teeth 22. Clinical erosion ** Factors for increased risk of caries may include but not be limited to: 1. High level of caries experience or demineralization 2. History of recurrent caries 3. High titers of cariogenic bacteria 4. Existing restoration(s) of poor quality 5. Poor oral hygiene 6. Inadequate fluoride exposure 7. Prolonged nursing (bottle or breast) 63 8. Frequent high sucrose content in diet 9. Poor family dental health 10. Developmental or acquired dental defects 11. Developmental or acquired disability 12. Xerostomia 13. Genetic abnormality of teeth 14. Many multisurface restorations 15. Chemo/radiation therapy 16. Eating disorders 17. Drug/alcohol abuse 18. Irregular dental care 64 B.16 PHARMACY/PRESCRIPTIONS PURPOSE To maintain adequate communication between the Pharmacy and Dental Department. PROCEDURE When it is determined by a dentist that a patient will require medication prior to or after treatment, a prescription shall be written on [appropriate form] and transported by [mechanism] to the pharmacy. The pharmacists will notify patients when the prescription is filled. The prescription shall be written in standard form in the outpatient notes or on the dental progress notes. Prescriptions shall be written utilizing medications available through the pharmacy and on the formulary. Prescriptions placed by phone to private pharmacies may occasionally be necessary. It will be the duty of the treating dentist to call the pharmacy chosen by the patient in the event this becomes a necessary course of action. Consultation with the Chief Pharmacist for the use of a DEA number will be the responsibility of the treating dentist. 65 B.17 DENTAL PAIN MANAGEMENT PURPOSE. The purpose of this document is to establish a policy for a Pain Management Program for the [Facility] Dental Program. BACKGROUND. Pain is a common part of the dental patient experience. There is a growing body of evidence that unrelieved pain carries with it great physiological and psychological risks, including increased metabolic rate, blood clotting, water retention, impaired immune function, anxiety, depression, loss of hope, and even suicide. Aggressive pain prevention and control can yield both short and long term benefits. Control of orofacial pain is not only a moral responsibility of the dental provider, but it is also a national priority within the DHHS. One strategy that has been used to assure optimal pain management is to develop formal means within dental programs to evaluate pain management practices and work to continuously improve outcomes. A) Each [Facility] Dental Program will develop a pain management policy that will include as a minimum, the following: 1) Philosophy of Care and Patient’s Rights for pain management and palliative care. If possible, this should be incorporated within the Patient Bill of Rights in each clinic, or if not incorporated, should be posted in a flyer in a conspicuous location in the dental clinic. (Exhibit 1) 2) An ad-hoc Pain Management Committee with an interdisciplinary approach to pain management utilizing non-pharmaceutical and pharmaceutical therapies should be developed for each [Facility] dental program. This may be a part of the Medical Staff bylaws and include all medical staff, but at a minimum under the auspices of a dental pain management plan, the committee should consist of the dental chief, the clinic pharmacist, the clinic Medical Director, and a patient advocate that may or may not be a staff member (but should not be a medical provider). This committee should meet at least on a quarterly basis to discuss (from a dental perspective) current pain management issues on patients. 3) A mechanism to document that dental staff review of the efficacy of treatment. This may range from noting the patient’s perceptions of pain management on the dental progress note to a more formal inquiry through a referral to another clinical provider. 4) Drug formulary appropriate for pain management and treatment of drug side effects. (Exhibit 2) 5) Identification of non-pharmaceutical and environmental therapies. (Exhibit 3) 6) Patient educational tools and sources for community resources for referrals. (Exhibit 4) 66 7) Identification of resources for assessment and management of addiction. (Exhibit 4) 8) Quality monitoring tools to evaluate the appropriateness and effectiveness of pain management. These may include: patient satisfaction, drug usage, length of therapy, and impact on quality of life, etc. (Exhibit 5) 9) Orientation plan for dental and other providers. B) Each [Facility] Dental Program will develop policies and procedures that address, as needed depending on services provided, safe medication prescriptions. DEFINITIONS (IHS). Pain: “An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.” Acute Pain: Acute pain is “the normal, predicted physiological response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma, and acute illness.” It is generally time-limited and responsive to pharmacotherapy or direct dental intervention. Examples in a dental setting where a patient may experience acute pain include, but are not limited to: severe orofacial trauma, vital tooth fracture, irreversible pulpitis with or without hyperemia, acute apical abscesses, or severe dental caries. Chronic Pain: “A pain state which is persistent (more a month) and in which the cause of the pain cannot be removed or otherwise treated.” Chronic pain may be associated with a long-term, incurable, or intractable medical conditions or diseases, or, in a dental setting, a chronic periodontal or pulpal infection, rampant tooth decay, or dentinal hypersensitivity (not all inclusive). Palliative Care: “An interdisciplinary approach to the study and care of patients with active, progressive, far advanced disease for whom the prognosis is limited and the focus of care is quality of life” (medical definition). In a dental setting, palliative care is offered to patients for whom the tooth condition is not easily diagnosed (e.g., cracked tooth syndrome), the condition may be reversible (e.g., pulpitis), or time to complete care is a limiting factor (e.g., walk-in patients). Examples of palliative care offered in a dental setting include the placement of a temporary or intermediate restorative material (pulpitis), root canal access (pulpitis), emergency extraction (acute infection, fractured root, etc.), or the prescribing of appropriate pharmacotherapies (for chronic infections or for pain relief). Physical Dependence: “Physical dependence on a controlled substance is a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence is expected with extended use of opioids and, by itself, does not equate with addiction.” In a dental setting, many of our patients may be on long-term pain management plans through their primary health care provider, and this may affect the efficacy of dental analgesic/anesthesia therapies. Addiction: “A primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, 67 compulsive use, continued use despite harm, and craving.” In a dental setting, it is important to not single-handedly make a diagnosis of “addiction” without first consulting the patient’s primary health care provider; some patients returning unexpectedly for additional analgesics or stronger medications may in fact be suffering from tolerance (see below) or pseudoaddiction (see below). Tolerance: “Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. This may include the need to increase the dose of an opioid to achieve the same level of analgesia. Such tolerance may or may not be evident during opioid treatment and does not equate with addiction.” Pseudoaddiction: “Pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management that can be mistaken for addiction.” This is a primary consideration of all dental providers, as often dental providers attribute a patient seeking additional analgesics to addiction. Substance Abuse: “Substance abuse is a maladaptive pattern of substance use manifested by recurrent and significant adverse consequences related to the repeated use of substances. It may include the use of any substance(s) for non-therapeutic purposes or use of medication for purposes other than those for which it is prescribed.” Signs of substance abuse in a dental setting may be demonstrated either through controlled analgesics or illegal drugs, and the dental care provider must recognize the signs of substance abuse and collaborate with other clinic health providers, mental health professionals, pharmacists, or substance abuse counselors if they perceive a problem (methamphetamine use, for example, creates the clinical “meth mouth” appearance, and other illicit drugs also have definitive clinical manifestations in the mouth). PROCEDURE The [Facility] Dental Program will promote and provide a standardized approach to the patient with pain that emphasizes a non-judgmental, multi-modal and individualized treatment plan. Such plans should increase access to known therapies, improve continuity of care, maximize communication and education for the relief of acute and chronic pain in all stages of a person’s life. Specifically, each dental program will consider the following guidelines in developing their pain management programs: A) Initial assessment and regular reassessment of pain. Pain screening and evaluation will be part of all dental patient encounters. When patient screening indicates the presence of pain, the patient’s self-report of the level of pain will be assessed (scale of 1-10 on the Dental Medical History Form). When pain is identified, the patient can be treated within the clinic or referred for treatment, depending on the professional judgment of the dental provider. The scope of treatment in a dental setting is based on a variety of factors - the setting, the services available, time available, staffing available. At a minimum, the dental provider should assess pain intensity and quality (for example, pain character, frequency, location, duration), based on both patient self-reporting and clinical measurements. An addiction history and/or assessment will be performed as indicated. Addiction is not a contraindication to treatment for pain, but can be a co-occurring condition that warrants medical attention. The potential for diversion of controlled 68 substances will not preclude their use but instead will mandate responsible and responsive health care. When assessing pain, the dental provider may perform a variety of clinical tests such as electric pulp testing (EPT), cold response (Endo-Ice), percussion sensitivity, palpation of the affected region, or, in some cases, access with a dental handpiece. B) Patient involvement in care decisions in order to facilitate effective management of the pain. Patient and provider must enter into a therapeutic alliance with mutual consent when pain is identified. Once a pattern of pain has been co-documented by the patient and provider, the standardized process for assessment and interdisciplinary treatment will be implemented and followed with documented evaluations for outcomes of relief of pain and improvement of functions. C) Education of patients, and families when appropriate, regarding risks and benefits and limitations of chosen pain relief modalities. Education of patients and families about their roles in effective pain management as well as side effects of pain treatment. D) Discussion about community and traditional beliefs and practices regarding pain, medication, and disability should be sought and respected by health care providers and administrators. E) Education of relevant practitioners in pain assessment and management. RESPONSIBILITIES A) [Facility] Dental Chief – will provide guidelines to [Facility] dental programs, and provide orientation to new dental staff. B) Clinic Dental Chief – will post pain policies in the clinic, train dental staff, and implement policies and procedures in collaboration with each clinic’s policies and the [Facility] dental policies. (1) The Dental Clinic Chief is responsible for the overall implementation and monitoring of the Pain Management/Palliative Care Program. Annual performance improvement reports documenting the on-going data collection and assessment process with impact of data analysis on improved outcomes will be prepared as part of each clinic’s reports to the [Facility] dental chief. (2) The Dental Clinic Chief is responsible for the formation of an interdisciplinary pain management/palliative care team that will develop the required [Facility] policy/procedures. The interdisciplinary team, at a minimum, will include a Medical Director of the facility, the pharmacist, the dental chief, and a patient advocate appointed by the clinic dental chief (may be a non-medical staff member). REFERENCES. Public Law 94-437; Health Care Improvement Act; Joint Commission of Accreditation of Healthcare Organizations Home Care/Hospice/Hospital/Ambulatory Care Standards; Patient Self Determination Act 1990; CFR 21-Food and Drugs – Volume 9, Part 1306 – Prescriptions; Model Guidelines for the Use of Controlled Substances for the Treatment of Pain; Federation of State Medical Boards of the U.S., Inc. 1998; American Academy of Pain Management; American Pain Society; American Society of Addiction 69 Medicine, 2001; Billings Area Pain Management/Palliative Medicine Program, Chronic Pain Management Strategies, both available at www.ihs.gov. (This item is optional. All policies may be updated and authorized on the Title page, or on each individual policy) EFFECTIVE DATE. This policy is effective upon date of signature of the [Facility] dental chief, and shall remain in effect until cancelled or superseded. SSU Dental Chief: ______________________________________ _____________ Reviewed by: (1) SSU Clinical Director: ____________________________ _____________ Date: Date: (2) SSU Chief Pharmacist: ____________________________ _____________ Date: (3) SSU CEO: ______________________________________ _____________ Date: (4) AAAHC Representative: ___________________________ _____________ Date: EXHIBITS. Exhibit 1 – philosophy of care/bill of rights Regarding dental pain management This patient Bill of Rights may be used in conjunction with each clinic’s published Bill of Rights, and should be posted in the dental clinic. *************** YOUR RIGHTS AS A PATIENT *************** 1. You have the right to appropriate assessment and management of orofacial pain. 2. You have the right to be treated as an individual with respect, concern, and dignity. 3. You have the right to uphold your cultural, psychosocial, spiritual, and ethical beliefs as these pertain to your state of health, your perception of your illness or injury, and to the health care provided, including medications prescribed by your dental provider. 4. You have the right to understand the nature of your illness, prognosis, the effects of the treatment, including full and prompt disclosure of adverse or unexpected outcomes to treatment, to ask for a second medical opinion concerning your state of illness and the type of treatment that is required and the risks involved. This means that you have the right to understand why medication is being prescribed for you. 70 5. You have the right to make a decision concerning your condition after you have been given the following under the informed consent clause (approval to do certain procedures/treatments): a. Complete information on the nature of your illness, treatments, alternatives, and the risks involved; b. The effects of the treatments/procedures as they may restrict you from normal activity; c. The name and qualification of the clinical provider performing the treatment; 6. You have the right to refuse treatment to the extent permitted by law, and to be informed of the risks involved in so doing. 7. You have the right to confidentiality, privacy, and security of your medical record and all other individually identifiable health information, including medications prescribed for your dental condition. You, or your legally designated representative, have the right to access information contained in your medical record, within limits of the law. 8. You have the right to know certain policies and protocols exist that apply to the identification of perceived painkiller addiction or tolerance, and that the dental provider may request additional resources from other providers to better be able to manage your orofacial pain. 9. You have the right to have your designee (you guardian, next of kin, or legally authorized responsible person) exercise, to the extent permitted by law, your rights if you have been judged incompetent in accordance with law, have been found by your physician to be medically incapable of understanding the proposed treatment or procedure or make a treatment decision, are unable to communicate your wishes regarding treatment, or are a non-emancipated minor. *************** YOUR RESPONSIBILITIES *************** In addition to your rights, you have certain responsibilities as a patient to contribute to your oral health care at the clinic. These responsibilities include: 1. Provide accurate and complete information about present complaints, past medical history, any medications you are or were taking, and other health matters as requested by the clinical provider, to the best of your knowledge. 2. Be compliant with the care plan and treatment recommended by the clinical provider, and agreed upon by you at the time of treatment. 3. Be responsible for your actions if you refuse treatment or are non-compliant with your care plan. 4. Make and keep your appointments. 5. Be ultimately responsible for your own health by taking necessary preventive steps, complying with medical treatment, and participating fully in your treatment plan. 6. Tell the dentist or dental staff if you have concerns about the management of your dental pain 71 so that effective changes can be made if possible. This dental facility is committed to providing you and your family with quality oral health care in a relaxed, respectful, and professional atmosphere. We believe that you and your health care provider are equal partners in your health care and that a favorable outcome can best be achieved by you fully participating in all aspects of your health care. Exhibit 2 – dental pain pharmaceutical protocol The following is the analgesic protocol for the [Facility] Dental Program. This protocol is only a recommendation, as it is the responsibility of the treating dentist to use his or her professional experience and the specific patient experience to determine the best course of therapy for that patient; it is inaccurate to assume that each and every patient should receive the same analgesics for the same dental condition. Each clinic is encouraged to devise a pain management plan customized to their clinical setting and patient population. Procedure Most common analgesic prescribed Other analgesic modalities Simple extraction (ADA Code 7140) Ibuprofen, 600mg, 20-30 tabs Tylenol #3, Vicodin 5/500 Acetominophen, 325mg, <30 Surgical extraction (ADA Code 7210) Ibuprofen, 600mg, 20-30 tabs + Tylenol #3, 12-20 tabs Vicodin 5/500 Acetominophen, 325mg, <30 Restorations-multiple Ibuprofen, 600 mg, 10-20 tabs (ADA Codes 2100) Acetominophen, 325, 10-20 Pulpitis-reversible Ibuprofen, 600 mg, 10-20 tabs + Dental therapy (IRM, Fl-, desensitizer) Acetominophen, 325, 10-20 Pulpitis-irreversible Or Abscess Ibuprofen, 600mg, 20-30 tabs + Tylenol #3, 12-20 tabs Vicodin 5/500 Acetominophen, 325mg, <30 TMJD Ibuprofen, 600mg, 20-30 tabs or more + Dental therapy (splint, manipulation) Steroid therapy (through medical department) Tooth fracture Ibuprofen, 600mg, 20-30 tabs or more + Tylenol #3, 12-20 tabs + Dental therapy (extraction, restoration) Vicodin 5/500 Acetominophen, 325mg, <30 Endodontic therapy Tylenol #3, 12-20 tabs Vicodin 5/500 72 (ADA Codes 3200) Acetominophen, 325mg, <30 Other potential pharmaceutical therapies for the relief of orofacial pain include Darvocet N-50 and N-100, Ultram 50-100 mg, and Percocet (for multiple extractions or large abscesses; however, as a Schedule II controlled substance, Percocet should rarely be used in a dental setting). Again, the above guidelines are only recommendations, as each provider has the autonomy to prescribe appropriate pharmaceutical therapies based on the level of pain, etc. Exhibit 3 – non-pharmaceutical dental therapies The following non-pharmaceutical dental therapies are available from [Facility] Dental Clinics for pain management (most actually include a pharmaceutical component, but do require a pharmacy prescription alone, although the dentist may combine “pharmaceutical” and “nonpharmaceutical” therapies for effective pain management): (1) Endodontic access – where pulpitis exists, the dentist has deemed the tooth salvageable, and the patient desires to save the tooth, the dentist may access the tooth pulp and remove the major dental nerves to the tooth, usually under local anesthesia. Limiting factors for this treatment option include time (usually more than 15 minutes is required to perform this procedure), diagnosis (irreversible pulpitis or necrosis/abscess), patient desires (to save tooth), medical condition (if a patient requires SBE prophylaxis prior to dental work, this procedure may not be done on a walk-in basis), staffing (a dental assistant and dentist must be present), and informed consent (the patient, if over age 18, or if under 18, the parent or LEGAL guardian must consent to the treatment). (2) Intermediate Restorative Material (IRM) – where pulpitis exists, but the dentist is unable to determine if it is reversible or irreversible, an IRM may be placed on the tooth with or without local anesthesia. Limiting factors for this treatment option include time (usually more than 10 minutes is required), diagnosis (reversible pulpitis), patient desires (to save tooth), medical condition (if anesthesia is to be done, and the patient requires SBE prophylaxis), staffing (a dentist must be present to diagnose the condition), availability of the material (IRM), and informed consent (see above). (3) Extraction – where pulpitis, necrosis/abscess, or severe periodontal disease is diagnosed, the dentist may extract the affected tooth to manage the patient’s pain. However, limiting factors for this treatment option include time (usually more than 15 minutes is required to extract a tooth), patient desires (to remove tooth), medical condition (see above), staffing (a dentist and dental assistant must be present), and informed consent (see above). In most [Facility] dental clinics, extractions are not usually the treatment of choice for dental walk-ins due to the time constraint. (4) Anesthesia – one short-term pain management is through the delivery of anesthesia to the affected site, although this is usually used in conjunction with another treatment modality. 73 (5) Temporo-mandibular joint manipulation – if pain is present in the TMJ, the dentist may either physically manipulate the TMJ or massage gently available muscles of mastication (temporalis, masseter, etc.). This may be combined with pharmaceutical therapy or may in itself relieve the patient’s pain. (6) Occlusal adjustment – if pain is present due to bruxism or occlusal trauma, the dentist may adjust the occlusion with a dental handpiece for effective pain management. (7) Denture adjustment – if pain is present in the edentulous patient, the dentist or dental assistant may adjust the patient’s denture, and the dentist may cauterize the ulcerated region of tissue affected by the ill-fitting denture (silver nitrate stick, etc.). (8) Other – the dentist, through his or her experience, may choose other nonpharmaceutical therapies that effectively manage pain. Exhibit 4 – community resources ([Facility] Dental program) Resources that may be available to assist patients with addiction problems: NAME OF FACILITY CONTACT Substance Abuse Programs: Other Tribal Resources: State and Local Resources: 74 phone Exhibit 5 – Quality Assurance Tool – Survey Each clinic is encouraged to periodically monitor patient satisfaction regarding dental policies on pain management. What follows is an example of a simple pain management survey that can be used or modified in order to assess current dental policies. The steps in quality assurance are: (1) identify a problem or issue (pain management); (2) assess the issue (through this survey); (3) discuss the survey and make recommendations for changes (through the Pain Management Committee at the clinic level); (4) implement the recommended changes (in policy or protocol); (5) re-assess the issue (through a follow-up survey instrument); (6) report reassessment and make further recommendations for changes (through the Pain Management Committee); and so on – the point is that quality assurance in pain management is a continuous process for the dental team. Instructions to patient: At your last dental visit, we provided you with pain medication or other therapies to relieve your pain. This short survey is designed to help us improve on how we treat pain in the dental office. Your honest and candid responses will help us review our existing policies on pain management for all of our valued patients. 1. At your last dental visit, what type of pain management therapy did the dentist perform? Please check ALL that apply. □ Pain medication (that you received from the pharmacy) □ Temporary filling was placed □ Tooth was pulled □ A root canal was started □ The dentist gave me anesthesia (a shot) □ The dentist adjusted my teeth or denture □ Nothing – the dentist did not attempt to relieve my pain 2. When you came into the dental office LAST TIME, how much pain did you have (on a scale from 1-10, with 10 being the highest)? ___ (write a number here) 3. When you left the dental office LAST TIME, how much pain did you have (on a scale from 110, with 10 being the highest)? ___ (write a number here) 4. Two to three days after your LAST dental visit, how much pain did you have (on a scale from 1-10, with 10 being the highest)? ___ (write a number here) 5. For the same tooth problem that you had last time, how much pain do you have TODAY (on a scale from 1-10, with 10 being the highest)? ___ (write a number here) 6. Based on your previous experiences with dental pain, how do you think the dental clinic/dentist managed your pain at your LAST VISIT? (Check only one box) □ Very good, pain was managed □ Good 75 □ Okay, about average □ Not good □ Poor, pain was not managed 7. What suggestions do you have for the dentist/dental staff regarding dental pain for patients at this clinic? ____________________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ ________ Answer these questions if you received a prescription for pain medicine at your last dental visit. 8. If you received pain medication at your LAST VISIT, was it enough to handle your pain (were enough pills given)? ___ YES ___ NO ___ NOT SURE 9. If you received pain medication at your LAST VISIT, was it strong enough to handle your pain? ___ YES ___ NO ___ NOT SURE 10. What suggestions do you have regarding the strength and amount of pain medication prescribed by the dentist to patients with dental pain? ____________________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ ________ Thank you for your participation in this survey. The results from this patient survey will be discussed with our Pain Management Committee, who may make recommendations for improving our pain management plan in the dental office. This survey will NOT affect the quality of care you receive in the dental office and is anonymous. If you wish to specifically discuss this survey or your own pain with your dental provider, however, you are welcome to talk with your dentist about this issue. 76 B.18 PHARMACOLOGIC MANAGEMENT of ORAL INFECTIONS Background The most common infections of the oral cavity can be attributed to resident oral microflora, namely Streptococcus and Staphylococcus species (gram positive bacteria). Oral infections may occur as tooth infections, pharyngeal infections, as post-surgical complications, or as unusual infections due to a patient’s immunocompromised status. When choosing an antibiotic, the dental provider must choose an antibiotic that targets the suspected microorganism, has low host toxicity, has low host sensitivity, is bacteriocidal, and has low resistance potential, all with a minimum of side effects to the patient. Indications/Contraindications for antibiotic therapy Antibiotics may be prescribed when all of the following conditions are met: 1. The patient presents to one of the service unit dental facilities or has previously been diagnosed by a service unit dentist with an oral infection (within the past month); 2. The dentist performs diagnostic tests to confirm a diagnosis of an abscess or cellulitis, to include at a minimum a clinical examination and radiographs or pulp testing if possible; or in the absence of a dentist on site, a medical provider performing diagnostic testing to confirm a diagnosis of oral infection; 3. The patient record contains an updated health history (either medical or dental forms) that details any allergies that the patient may have had in the past. Antibiotics may not be prescribed under the following conditions: 1. The patient does not present (show up) to the service unit dental or medical facility, and where there is no documentation to support antibiotic therapy (in other words, the dentist is precluded from making diagnoses by triaging the patient over the phone without a sufficient documented history of infection). 2. The patient presents to the clinic but the dentist (or in his/her absence, the medical provider) cannot make a definitive diagnosis of an oral infection based on the available clinical evidence (for example, if the patient is afebrile and diagnostic tests are negative). 3. The patient record does not contain an up-to-date health history (within the past year). Characteristics of common antibiotics Because most oral infections are caused by resident gram positive bacteria, a broad spectrum antibiotic that targets gram positive bacteria should be prescribed in most situations. Penicillin V with potassium (Pen VK) is THE drug of choice for most facial infections, according to the Centers for Disease Control and Prevention. Penicillin V is bactericidal, is acid stable (isn’t broken down easily by gastric acid), and is beta lactamase labile. Although the chemical composition of Penicillin V contains sulfur, it is safe to prescribe Pen V to patients with sulfur allergy as the sulfur is in elemental form. When prescribing penicillin, it is very important to have the patient take the antiobiotic on an empty stomach if possible to increase a rapid absorption, even though many pharmacists will encourage patients to take the antibiotics with food or water. In addition, Pen V should be prescribed in a manner to give the patient a maximum load at the beginning of therapy, and, since 75% of penicillin is excreted in the first four hours, patients should be encouraged to take the antibiotic every six hours, not simply four times daily – if the patient takes the antibiotic q.i.d., and takes the antibiotic at mealtimes only, two things will happen: absorption of Pen V will be delayed due to taking it with food, and there 77 will be no antibiotic coverage late in the evening (if the patient takes the last tablet at 9 p.m., for example, the patient would not have antibiotic coverage from 1 a.m. the next morning until they take the next tablet). Therefore, the prescription for Penicillin V would appear as: Rx: Penicillin V-K, 500 mg tablets Disp: 30 tablets Sig: Take two tablets to start, then one tablet every six hours until all tablets are gone Penicillin is contraindicated in those patients that report a history of an allergic reaction to it. Amoxicillin is a penicillin antiobiotic that is bacericidal, is of a broader spectrum than Penicillin V, is acide stable, and beta lactamase labile. It is not the drug of choice for most oral infections, although most dentists try to use it in this way. However, amoxillin is the preferable regimen for prophylaxis for subacute bacterial endocarditis (SBE), according to the American Heart Association. The SBE prophylaxis prescription for amoxillin would appear as: Rx: Amoxicillin, 500 mg tablets Disp: 4 tablets Sig: Take four tablets one hour before dental appointment For SBE prophylaxis, the AHA states that prophylactic antibiotics be taken one hour before a dental appointment. Dentists and pharmacists have questioned whether this time frame can be changed to say, 30 minutes. However, in the absence of clear, written guidance from the AHA or CDC regarding this, the dental provider must adhere to the one-hour timeline before any procedures are begun. What should be done when a patient does not respond to Pen V? Often, dentists immediately prescribe another class of antibiotics. However, two other choices are more appropriate if the patient does not respond to Pen V within 48 hours. First, the dentist may prescribe 875 or 1000 mg Augmentin (every 12 hours). Augmentin is also acid stable and bactericidal, is a broad spectrum antibiotic, and is a combination of amoxicillin and clavulanic acid. Secondly, the dentist may prescribe 500 Penicillin V plus a broad-spectrum antibiotic such as Flagyl (metronidazole). However, the dentist should be mindful of the potential adverse effects of Flagyl (see Metronidazole section). Cephalosporin antibiotics are bactericidal, broad spectrum, acid stable, and beta lactamase stable or labile (depending on cross-sensitivity with penicillin), but are NOT preferable antibiotics for oral infections. For patients with sensitivity to penicillin, 6-8% of those patients may have a delayed reaction to the cephalosporins (if the patient reported that they had a history of a “mild” reaction to penicillin), but >20% of the patients may have a Type I reaction (anaphylaxis) if they reported a similar Type I reaction to penicillin in the past. Therefore, the dentist should refrain from using cephalosporin antibiotics as an alternative to penicillin due to penicillin sensitivity. However, if the dentist does wish to prescribe a cephalosporin, a first generation cephalosporin (Keflex, Duricef) should be prescribed, such as an alternative to penicillin for SBE prophylaxis, the prescriptioon should be written such as follows: Rx: Cephalexin, 500 mg tablets Disp: 4 tablets Sig: Take four tablets by mouth one hour before dental appointment Bottom line: If a patient is allergic to penicillin, the dentist shouldn’t even attempt to prescribe cephalosporin, and should prescribe clindamycin as an alternative instead. 78 Erythromycin (Ery-tab) has no use in dentistry at all, according to Dr. Harold Crossley from the University of Maryland Dental School. Additionally, erythromycin is NOT one of the alternative antibiotics that can be used for SBE prophylaxis. Clindamycin (Cleocin) is bacteriostatic and bacteriocidal, is acid stable, and is a broad spectrum antibiotic. One published adverse effect of clindamycin is pseudomembranous colitis (PMC)/ulcerative colitis. Approximately 80% of PMC cases are nosocomial, and patients are at very low risk of having this side effect in a dental setting. However, if a patient reports diarrhea after starting clindamycin therapy, the dental provider should tell the patient to immediately cease taking the antibiotic, and if the diarrhea or GI symptoms continue (for 72 hours), the dentist should refer the patient to a physician (internist) for follow-up care. Clindamycin is the drug of choice for patients allergic to penicillin, and should be written as follows: Rx: Clindamycin, 300 mg capsules Disp: 16 capsules (or 32 if 150 mg capsules are prescribed) Sig: Take 2 (4) capsules to start, and then one capsule (2) every 12 hours for seven days The dentist may prescribe clindamycin for SBE prophylaxis as follows: Rx: Clindamycin, 300 mg capsules Disp: 2 capsules Sig: Take 2 capsules one hour before dental appointment Azithromycin is an extended spectrum antibiotic that can be used as an alternative regimen for SBE prophylaxis as follows: Rx: Azithromycin, 250 mg tablets Disp: 2 tablets Sig: Take 2 tablets one hour before dental appointment Tetracyclines are broad-spectrum bacteriostatic antibiotics that target gram positive and gram-negative bacterial infections. However, due to the many adverse reactions possible with tetracyclines, they should not be routinely be used for most oral infections. Adverse reactions possible include gastointestinal distress and nausea, hepatic and renal toxicity, tetragenecity in pregnant women, the possibility of superinfections such as candidiasis, and photosensitivity (even in subtherapeutic doses). Due to the GI problems, which may be as severe as esophagitis, patients receiving tetracyclines should drink lots of water when taking the antibiotic. Tetracycline is contraindicated for patients with orthopedic prostheses, and are contraindicated for patients taking penicillin (for example, if an adolescent is taking a tetracylcline for acne, the dentist should not prescribe a penicillin for that patient, but rather clindamycin). Tetracyclines are also contraindicated for patients on oral anticoagulant therapy (coumadin), and patients prescribed tetracycline in any dosage should be told to not take the antibiotic with antacids or with milk or other dairy products. For patients receiving the IHS Diabetic Protocol, the dentist should warn the patient of these adverse properties, and the prescription should look as follows: Rx: Doxycycline, 100 mg Disp: 28 tabs Sig: Take 1 tab every 12 hours for two weeks (while undergoing periodontal therapy) 79 Metronidazole (Flagyl) is a broad spectrum bacteriocidal antibiotic that also has several adverse effects possible. These include GI effects, oral effects (ulcerations, metallic taste), CNS effects, and renal toxicity. Most importantly, alcohol use (even swishing with an alcohol-based mouthwash) is contraindicated with metonidazole. Quinolones and fluoroquinolones (Cipro, Floxin) are broad spectrum, bacteriocidal antibiotics that are not routinely used to treat dental infections, especially in light of the fact that due to the 9/11 aftermath, there has been a 40% increase in bacterial resistance to these drugs just within the last two years. Fluconazole (Diflucan) is a systemic antifungal agent that is the drug of choice for oral candidiasis. It is important for the dental provider to also treat the denture of the edentulous patient when prescribing Diflucan, which may be prescribed as follows: Rx: Diflucan, 100mg tablets Disp: 15 tablets Sig: Take 2 tablets the first day, then 1 tablet daily for 13 days Acyclovir (Zovirax) is an antiviral drug that is the drug of choice for treating herpetic lesions, and can be prescribed as follows: Rx: Zovirax Ointment, 5% Disp: 15 g Sig: Apply small amount to affected area every three hours six times a day for 7 days At this time, there is inconclusive evidence of the efficacy of Acyclovir, and this drug is not on the service unit formulary. An alternative, Abreva (10% cream), is available as an over-the-counter topical preparation, but is quite expensive to the patient (around $17 per tube). Frequently asked questions (FAQ’s) 1. My patient is already taking antibiotics for an infection. How do I provide, or do I need to provide, SBE prophylaxis? The dentist will need to provide SBE prophylaxis as recommended by the AHA guidelines as if the patient weren’t taking other antibiotics, with one exception: if the patient has taken amoxicillin for seven days or more, then the dentist should prescribe an antibiotic other than amoxicillin for SBE prophylaxis. 2. If the patient’s physician dictates that a certain antibiotic be used for SBE prophylaxis, and this contradicts with current AHA guidelines, who do you follow? The AHA guidelines should be followed. 3. What antibiotics should never be used for SBE prophylaxis? Erythromycins and tetracyclines. 4. Should patients with total joint replacements, should SBE prophylaxis be provided? Although there is no conclusive evidence that prophylactic antibiotics are necessary for patients with total joint replacements, many physicians and orthopedists request prophylactic coverage for high-risk dental procedures. AHA and CDC guidelines state that high-risk patients be covered with prophylactic antibiotics before high-risk dental procedures. 80 5. Who is considered to be a high-risk patient in regard to prophylaxis for joint replacements? Patients that are otherwise immunocompromised – HIV, Type I diabetics, rheumatoid arthritis, joint replacement within the past two years. 6. What is considered to be a high-risk dental procedure in regard to prophylaxis for joint replacements? Extractions or other oral surgery, scaling and root planing, endodontics. Periodontal probing may be considered a high-risk dental procedure. 81 Schematic diagram for prescribing antibiotics for oral infections Patient presents to clinic with pain S/S of oral infection No S/S of oral infection Antibiotic prescription Continue to monitor Patient not allergic to penicillin Patient allergic to penicillin Patient taking tetracycline Pen V (500 mg) – 30 2 tabs to start, then q6h X 7 days Clindamycin (300 mg) - 30 2 tabs to start, then q6h X 7d Be aware of PMC! or Infection does not respond to Pen V Within 48 hours Azithromycin (250 mg) - 4 Once daily for 3-4 days Augmentin (875 mg) – 10 2 tabs to start, then q12h X 4 days or Ketek (800 mg) - 1 One tab for 1 day Not yet formulary item or Pen V (500 mg) + Flagyl (500mg)-28 Q6h X 7 days Be aware of alcohol! or Cephalexin (500) - 30 2 tabs to start, then q6h X7d Infection does not respond to either regimen or Amoxicillin (500) – 32 2 tabs to start, then tid X 10d 82 B.19 EXTRACTED TEETH PURPOSE To establish a policy for the disposal of teeth and soft tissue following dental treatment. PROCEDURE All patients will be offered the opportunity to keep their extracted teeth or oral tissue removed during a dental surgery (if the tooth or tissue is not being analyzed for pathology, See Policy B.22). If a patient wishes to save an extracted tooth it will be cleaned and surface-disinfected with an EPA-registered hospital disinfectant with intermediate-level activity and placed in a water-resistant bag or other suitable container. Disposal All oral hard and soft tissues shall be disposed of according to guidelines established by the Centers for Disease Control and prevention, and comply with regulations set forth by OSHA and the Environmental Protection Agency. Extracted teeth that are being discarded are subject to the containerization and labeling provisions outlined by OSHA's bloodborne pathogens standard. OSHA considers extracted teeth to be potentially infectious material that should be disposed in medical waste containers. Extracted teeth sent to a dental laboratory for shade or size comparisons should be cleaned, surface-disinfected with an EPA-registered hospital disinfectant with intermediate-level activity (i.e., tuberculocidal claim), and transported in a manner consistent with OSHA regulations. However, extracted teeth can be returned to patients on request, at which time provisions of the standard no longer apply. Extracted teeth containing dental amalgam should be placed in the “Contact Scrap Amalgam” container, which will be sent to an amalgam recycler. Teeth saved for educational purposes Extracted teeth are occasionally collected for use in pre-clinical educational training. Written consent from the patient shall be obtained for teeth collected for use in training or research. These teeth should be cleaned of visible blood and gross debris and maintained in a hydrated state in a well-constructed closed container during transport. The container should be labeled with the biohazard symbol. Because these teeth will be autoclaved before clinical exercises or study, use of the most economical storage solution (e.g., water or saline) is practical. Liquid chemical germicides can also be used but do not reliably disinfect both external surface and interior pulp tissue. Before being used in an educational setting, the teeth should be heat-sterilized to allow safe handling. Microbial growth can be eliminated by using an autoclave cycle for 40 minutes. 83 B.20 HYPERTENSION SCREENING AND TREATMENT GUIDELINES PURPOSE According to ADA recommendations, “BP [blood pressure] readings should be taken for all new patients and for all recall patients on at least an annual basis. People who have hypertension should have BP assessed at each visit in which significant dental procedures are accomplished”. (JADA, 2004;135: 576-584) The purpose of this policy is to establish protocols for monitoring blood pressure for dental patients in accordance with American Dental Association recommendations. PROCEDURE Blood pressure will be taken [state method such as: using an automated blood pressure monitor] on all new patients and for all recall patients on at least an annual basis. People who have hypertension will have BP assessed at each visit in which significant dental procedures are accomplished. A. Blood pressure will be recorded on the [appropriate form] or progress note in the chart. B. Referral: i. Emergency Treatment: Patients with Systolic over 180 and/or diastolic over 100 should have pain controlled with local anesthesia (without vasoconstrictor). If BP does not improve, call the [appropriate referral site] or the patient’s physician for a consultation. Following emergency dental treatment, the patient should be referred to [appropriate referral site] for evaluation. ii. Routine care (elective dental treatment, patient is not in pain): Patients with systolic over 180 and/or diastolic over 100, call the [appropriate referral site] clinic or the patient’s physician for a consultation. Appropriate dental care will be rendered according to physician’s recommendations. iii. Any patient with systolic over 200 and/or diastolic over 110 should be referred immediately to the[appropriate referral site]. (Dental provider should first call [referral site] for a phone consult and to advise the [referral site] a patient is being referred.) iv. Alternatively the dental provider may consult with the patient’s physician regarding need for treatment and/or dental considerations 84 B.21 PREMEDICATION TO PREVENT INFECTIVE ENDOCARDITIS PURPOSE The purpose of this policy is to set guidelines for premedicating dental patients to prevent Infective Endocarditis (IE) that may result from dental treatment. The policy adheres to the 2007 recommendations by the American Heart Association (AHA) and is endorsed by the American Dental Association. Primary reasons for revising IE Prophylaxis guidelines are: IE is much more likely to result from frequent exposure to random bacteremias associated with daily activities than from bacteremia caused by a dental, Gastro Intestinal (GI) tract or Gastro Urinary (GU) tract procedure. Prophylaxis may prevent an exceedingly small number of cases of IE, if any, in individuals who undergo a dental, GI tract, or GU tract procedure. The risk of antibiotic-associated adverse events exceeds the benefit, if any, from prophylactic antibiotic therapy. Maintenance of optimal oral health and hygiene may reduce the incidence of bacteremia from daily activities and is more important than prophylactic antibiotics for a dental procedure to reduce the risk of IE. PROCEDURE The 2007 AHA guidelines say patients who have taken prophylactic antibiotics routinely in the past but no longer need them include people with: mitral valve prolapse rheumatic heart disease bicuspid valve disease calcified aortic stenosis congenital heart conditions such as ventricular septal defect, atrial septal defect and hypertrophic cardiomyopathy. (The new guidelines are aimed at patients who would have the greatest danger of a bad outcome if they developed a heart infection.) 85 Procedures: 1. All dental patients or parent/guardian of dental patients will complete and sign a written medical history annually. The medical history will be reviewed at each appointment and updated as needed. 2. Patients with the following conditions will receive preventive antibiotics prior to a dental procedure that requires antibiotic prophylaxis: (see item #3): a. artificial heart valves b. a history of infective endocarditis c. certain specific, serious congenital (present from birth) heart conditions, including i. unrepaired or incompletely repaired cyanotic congenital heart disease, including those with palliative shunts and conduits ii. a completely repaired congenital heart defect with prosthetic material or device, whether placed by surgery or by catheter intervention, during the first six months after the procedure iii. any repaired congenital heart defect with residual defect at the site or adjacent to the site of a prosthetic patch or a prosthetic device d. a cardiac transplant that develops a problem in a heart valve. 3. Dental Procedures that require antibiotic prophylaxis: All dental procedures that involve manipulation of gingival tissue or the periapical region of teeth or perforation of the oral mucosa * *The following procedures and events do not need prophylaxis: routine anesthetic injections through noninfected tissue, taking dental radiographs, placement of removable prosthodontic or orthodontic appliances, adjustment of orthodontic appliances, placement of orthodontic brackets, shedding of deciduous teeth and bleeding from trauma to the lips or oral mucosa. 86 4. Premedication Regimen for Dental patients who meet the criteria listed in item #2: Situation Agent Oral Amoxicillin Unable to take oral medication Allergic to penicillins or ampicillin Oral Allergic to penicillins or ampicillin AND unable to take oral medication Regimen- Single dose 30-60 minutes before procedure Adults Children 2 gm 50 mg/kg Ampicillin OR Cefazolin or ceftriaxone Cephalexin** + OR Clindamycin OR Azithromycin or clarithromycin Cefazolin or ceftriaxone OR Clindamycin 2 g IM or IV* 50 mg/kg IM or IV 1 g IM or IV 50 mg/kg IM or IV 2g 50 mg/kg 600 mg 20 mg/kg 500 mg 15 mg/kg 1 g IM or IV 50 mg/kg IM or IV 600 mg IM or IV 20 mg/kg IM or IV * IM–intramuscular; IV–intravenous. ** or other first or second generation oral cephalosporin in equivalent adult or pediatric dosage. + Cephalosporins should not be used in an individual with a history of anaphylaxis, angioedema, or urticaria with penicillins or ampicillin 5. An antibiotic for prophylaxis should be administered in a single dose before the procedure. If the dosage of antibiotic is inadvertently not administered before the procedure, the dosage may be administered up to 2 hours after the procedure. However, administration of the dosage after the procedure should be considered only when the patient did not receive the pre-procedural dose. 6. If a patient is already receiving chronic antibiotic therapy with an antibiotic that is also recommended for IE prophylaxis for a dental procedure, whenever possible an antibiotic from a different class will be used rather than to increase the dosage of the current antibiotic. 7. Patients with congenital heart disease can have complicated circumstances. Prior beginning to any dental treatment requiring antibiotic prophylaxis, the dental provider should check with the patient’s cardiologist or primary care provider to determine antibiotic prophylaxis needs or other considerations pertaining to dental treatment or progression of oral disease. 87 B.22 PREMEDICATION FOR PATIENTS WITH COMPLETE JOINT REPLACEMENT PURPOSE The purpose of this policy is to set guidelines for premedicating dental patients to prevent joint infection that may result from dental treatment that may cause bacteremia. Note: The American Academy of Orthopaedic Surgeons and the Association of Oral and Maxillofacial Surgeons differ in their recommendation for antibiotic prophylaxis for patients with total joint replacement. The dental chief should consider each protocol, and in consultation with the facility’s medical staff, determine which protocol to follow. POLICY #1: American Academy of Orthopaedic Surgeons This facility adheres to the American Academy of Orthopaedic Surgeons guidelines for premedication of patient with total joint replacement. http://www.aaos.org/about/papers/advistmt/1033.asp According to the AAOS 2010 Information Statement and Clinical Guidelines: “More than 1,000,000 total joint arthroplasties are performed annually in the United States, of which approximately 7 percent are revision procedures. Deep infections of total joint replacements usually result in failure of the initial operation and the need for extensive revision, treatment and cost. Due to the use of perioperative antibiotic prophylaxis and other technical advances, deep infection occurring in the immediate postoperative period resulting from intraoperative contamination has been markedly reduced in the past 20 years. Bacteremia from a variety of sources can cause hematogenous seeding of bacteria onto joint implants, both in the early postoperative period and for many years following implantation. 2 In addition, bacteremia may occur in the course of normal daily life 3-5 and concurrently with dental, urologic and other surgical and medical procedures. The analogy of late prosthetic joint infections with infective endocarditis is invalid as the anatomy, blood supply, microorganisms and mechanisms of infection are all different. It is likely that bacteremia associated with acute infection in the oral cavity,skin, respiratory, gastrointestinal and urogenital systems and/or other sites can and do cause late implant infection. Practitioners should maintain a high index of suspicion for any change or unusual signs and symptoms (e.g. pain, swelling, fever, joint warm to touch) in patients with total joint prostheses. Any patient with an acute prosthetic joint infection should be vigorously treated with elimination of the source of the infection and appropriate therapeutic antibiotics. Patients with joint replacements who are having invasive procedures or who have other infections are at increased risk of hematogenous seeding of their prosthesis. Antibiotic prophylaxis may be considered, for those patients who have had previous prosthetic joint infections, and for those with other conditions that may predispose the patient to infection (Table 1). 8,10-16 There is evidence that some immunocompromised patients with total joint replacements may be at higher risk for hematogenous infections.10-18 However, patients with pins, plates and screws, or other orthopaedic hardware that is not within a synovial joint are not at increased risk for hematogenous seeding by microorganisms. 88 Given the potential adverse outcomes and cost of treating an infected joint replacement, the AAOS recommends that clinicians consider antibiotic prophylaxis for joint replacement patients with one or more of the following risk factors prior to any invasive procedure that may cause bacteremia. Table 1. Patients at Potential Increased Risk of Hematogenous Total Joint Infection8,10-16,18 All patients with prosthetic joint replacement Immunocompromised/immunosuppressed patients Inflammatory arthropathies (e.g.: rheumatoid arthritis, systemic lupus erythematosus) Drug-induced immunosuppression Radiation-induced immunosuppression Patients with co-morbidities (e.g.: diabetes, obesity, HIV, smoking) Previous prosthetic joint infections Malnourishment Hemophilia HIV infection Insulin-dependent (Type 1) diabetes Malignancy Megaprostheses Prophylactic antibiotics prior to any procedure that may cause bacteremia are chosen on the basis of its activity against endogenous flora that would likely to be encountered from any secondary other source of bacteremia, its toxicity, and its cost. In order to prevent bacteremia, an appropriate dose of a prophylactic antibiotic should be given prior to the procedure so that an effective tissue concentration is present at the time of instrumentation or incision in order to protect the patient’s prosthetic joint from a bacteremia induced periprosthetic sepsis. Current prophylactic antibiotic recommendations for these different procedures are listed in Table 2. 19 Occasionally, a patient with a joint prosthesis may present to a given clinician with a recommendation from his/her orthopaedic surgeon that is not consistent with these recommendations. This could be due to lack of familiarity with the recommendations or to special considerations about the patient's medical condition which are not known to either the clinician or orthopaedic surgeon. In this situation, the clinician is encouraged to consult with the orthopaedic surgeon to determine if there are any special considerations that might affect the clinician’s decision on whether or not to pre-medicate, and may wish to share a copy of these recommendations with the physician, if appropriate. After this consultation, the clinician may decide to follow the orthopaedic surgeon’s recommendation, or, if in the clinician’s professional judgment, antibiotic prophylaxis is not indicated, may decide to proceed without antibiotic prophylaxis.” Prophylactic antibiotics prior to any procedure that may cause bacteremia are chosen on the basis of its activity against endogenous flora that would likely to be encountered from any secondary other source of bacteremia, its toxicity, and its cost. In order to prevent bacteremia, an appropriate dose of a prophylactic antibiotic should be given prior to the procedure so that an 89 effective tissue concentration is present at the time of instrumentation or incision in order to protect the patient’s prosthetic joint from a bacteremia induced periprosthetic sepsis. Current prophylactic antibiotic recommendations for these different procedures are listed in Table 2. 19 Occasionally, a patient with a joint prosthesis may present to a given clinician with a recommendation from his/her orthopaedic surgeon that is not consistent with these recommendations. This could be due to lack of familiarity with the recommendations or to special considerations about the patient's medical condition which are not known to either the clinician or orthopaedic surgeon. In this situation, the clinician is encouraged to consult with the orthopaedic surgeon to determine if there are any special considerations that might affect the clinician’s decision on whether or not to pre-medicate, and may wish to share a copy of these recommendations with the physician, if appropriate. After this consultation, the clinician may decide to follow the orthopaedic surgeon’s recommendation, or, if in the clinician’s professional judgment, antibiotic prophylaxis is not indicated, may decide to proceed without antibiotic prophylaxis. 90 Table 2. 91 POLICY #2: American Dental Association and Association of Oral and Maxillofacial Surgeons This facility adheres to the American Dental Association (ADA) and Association of Oral and Maxillofacial Surgeons (AAOMS) guidelines for premedication of patient with total joint replacement. The [Facility] dental clinic will follow the ADA and AAOMS Advisory Statement and use the following clinical guidelines to determine the need for, drugs, and regimens of antibiotic prophylaxis for patients with total joint replacement. According to the ADA and AAOMS 2003 Advisory Statement: “There is limited evidence that some immunocompromised patients with total joint replacements (Table 1) may be at higher risk of experiencing hematogenous infections.12,16-23 Antibiotic prophylaxis for such patients undergoing dental procedures with a higher bacteremic risk (as defined in Table 2) should be considered using an empirical regimen (Table 3). In addition, antibiotic prophylaxis may be considered when the higher-risk dental procedures (again, as defined in Table 2) are performed on dental patients within two years post–implant surgery,3 on those who have had previous prosthetic joint infections and on those with some other conditions” JADA, Vol. 134, July 2003 p 895 (Table 1). PATIENTS AT POTENTIAL INCREASED RISK OF EXPERIENCING HEMOTOGENOUS TOTAL JOINT INFECTION* PATIENT TYPE All patients during first two years following CONDITION PLACING PATIENT AT RISK N/A† joint replacement Immunocompromised/immunosuppressed patients Inflammatory arthropathies such as rheumatoid arthritis, systemic lupus erythematosus Drug- or radiation-induced immunosuppression Patients with comorbidities‡ Previous prosthetic joint infections Malnourishment Hemophilia HIV infection Insulin-dependent (type 1) diabetes Malignancy * Based on Ching and colleagues,12 Brause,16 Murray and colleagues,17 Poss and colleagues,18 Jacobson and colleagues,19 Johnson and Bannister,20 Jacobson and colleagues21 and Berbari and colleagues.22 † N/A: Not applicable. ‡ Conditions shown for patients in this category are examples only; there may be additional conditions that place such patients at risk of experiencing hematogenous total joint infection. 92 Table 2 INCIDENCE STRATIFICATION OF BACTEREMIC DENTAL PROCEDURES Incidence Dental Procedure Higher Incidence* Dental extractions Periodontal procedures, including surgery, subgingival placement of antibiotic fibers/strips, scaling and root planing, probing, recall maintenance Dental implant placement and replantation of avulsed teeth Endodontic (root canal) instrumentation or surgery only beyond the apex Initial placement of orthodontic bands but not brackets Intraligamentary and intraosseous local anesthetic injections Prophylactic cleaning of teeth or implants where bleeding is anticipated Lower Incidence Restorative dentistry¶ (operative and prosthodontic) with/without retraction cord Local anesthetic injections (nonintraligamentary and nonintraosseous) Intracanal endodontic treatment; post placement and buildup Placement of rubber dam Postoperative suture removal Placement of removable prosthodontic/orthodontic appliances Taking of oral impressions Fluoride treatments Taking of oral radiographs Orthodontic appliance adjustment * Adapted with permission of the publisher from Dajani AS, Taubert KA, Wilson W, et al.23 † Prophylaxis should be considered for patients with total joint replacement who meet the criteria in Table 1. No other patients with orthopedic implants should be considered for antibiotic prophylaxis prior to dental treatment/procedures. ‡ Prophylaxis not indicated. § Clinical judgment may indicate antibiotic use in selected circumstances that may create significant bleeding. ¶ Includes restoration of carious (decayed) or missing teeth. 93 Table 3 SUGGESTED ANTIBIOTIC PROPHYLACXIS REGIMENS.* Patient Type Suggested Drug Patients not allergic to Cephalexin, cephradine or penicillin amoxicillin Patients not allergic to Cefazolin or ampicillin penicillin and unable to take oral medications Patients allergic to penicillin Clindamycin Regimen 2 grams orally 1 hour prior to dental procedure Cefazolin 1 g or ampicillin 2 g intramuscularly or intravenously 1 hour prior to the dental procedure 600 milligrams orally 1 hour prior to the dental procedure Patients allergic to penicillin Clindamycin 600 mg intravenously 1 hour and unable prior to the dental to take oral medications procedure* * No second doses are recommended for any of these dosing regimens. 94 B.23 MEDICAL EMERGENCIES IN THE DENTAL CLINIC PURPOSE Patients in the dental clinic should be protected while receiving dental care in the [Facility] dental clinic. To insure their safety, a policy will be in place to insure quick and efficient response to any emergency arising in the dental clinic. PROCEDURE Dental providers should be aware that urgent or emergent medical and dental situations might arise in their clinics. It is their responsibility to ensure that they themselves and their dental staffs are well prepared to cope efficiently, quickly, and appropriately on such occasions. Preparation and training must take place well in advance so that when action is needed in potentially life-threatening situations appropriate action will be taken. Training Basic Life Support (BLS) All dental staff will maintain certification in Basic Life Support (BLS). Certification may be sponsored by either the American Heart Association or the American Red Cross. When a patient, visitor or other individual is observed in distress, staff will respond according to current BLS recommendations. [Insert other specific requirements for emergency response] In-Service Training Annually the emergency response plan and staff assignments listed below will be held for all dental staff. In-service training will be provided as needed to review appropriate responses to medical emergencies including but not limited to: seizures, syncope (fainting), hyperventilation, cardiac and respiratory distress, chest pain, drug related emergencies, allergic or toxic reaction, asthma, insulin shock, diabetic coma or airway obstruction. Emergency Response Plan Staff Assignments In case of a medical emergency in the dental clinic, staff assignments are as follows: [Describe clinic specific procedures for response to medical emergencies] Example: 1. Provider treating the patient with the medical emergency will stay with the patient and call for help. The provider will monitor the patient’s vital signs and maintain airway, support breathing and monitor circulation until medical assistance arrives. 2. The nearest dental assistant will get the oxygen tank and set it up for the provider to administer oxygen to the patient. 3. The receptionist or nearest dental assistant will phone for help. 95 Equipment and Medications Equipment for providing supplemental oxygen to hypoxic patients should be available in all dental clinics. This equipment should provide capabilities for forced respiration through the use of an Ambu bag and a face mask that can produce an air tight seal around the patient's nose and mouth. An Ambu-bag is ideal for such purposes. Oxygen and ambu-bags are located [state location] Automated External Defibrillators (AED) will be available, in good repair, and maintained ready for use. Automated External Defibrillators are located [state location] [The Council on Scientific Affairs of the American Dental Association recommends that each dental office examine local needs and determine appropriate emergency kit needs. Kit contents should be based on individual practitioner training and requirements. Dental staff may elect to keep emergency drugs, or to defer to medical staff for emergency services. Select the procedures that best serve the facility. Some State Practice Acts specify required equipment or drugs be available to the dental staff. Check the appropriate State Dental Practice act for requirements] Emergency Drugs (For those clinics that elect to maintain an Emergency Drug Kit) Emergency medications will be checked monthly for expiration and a log will be maintained of Emergency Kit monitoring. Expired drugs will be replaced at least 2 months prior to the expiration date. Annually, the dental staff will have an in-service on all emergency kit drugs, dosage, and administration. The dental emergency kit will include: 1. Positive pressure oxygen 2. Ambu-bag 3. Sphygmomanometer and Stethoscope 4. Benadryl 50 mg/ml injectable 5. Tubex Hypodermic Syringe 6. 5% Dextrose 7. Butterfly I-V set 8. Epinephrine 1:1000 Tubex x 2 9. Glucose Option for Dental Clinics that defer to Medical Department for Emergency Services Emergency Kit without Emergency Drugs The dental clinic will maintain an emergency kit containing an Epi pen and a source of glucose. No emergency drugs will be kept in the dental clinic. In case of an emergency, the dental staff will notify the medical department or call Emergency Services for medical support. The dental emergency kit will contain: 96 1. Positive pressure oxygen 2. Ambu-bag 3. Epi pen 4. Glucose Documentation All emergency procedures will be recorded in the patients chart including: symptoms, time of onset of symptoms, support services, drugs administered (time and dosage), referrals or calls for support services, progression of patient’s signs and symptoms and instructions given to the patient. 97 B.24 REPORTING DOMESTIC VIOLENCE and NEGLECT PURPOSE This policy is to ensure that appropriate medical care and emotional support be given to those experiencing abuse and mistreatment from others and to report this suspicion to the proper authorities. This policy is designed to protect those from civil and criminal liability if the report is made in good faith. (Check State laws to ensure protection from liability) PROCEDURE Willful physical abuse by adults is a significant cause of disability or death in young children. Reporting of suspected cases is mandatory. "In an attempt to protect children, the law requires care providers to report their suspicions to the police department or any special children's protective service operating in the community so that cases can be investigated and appropriate measures taken for the safety of the child. State law protects physicians and dentists against liability for reporting. Once suspicion of willful injury has been aroused or confirmed, protective hospitalization is mandatory to prevent possible repetition."[modify as needed to meet state requirements] The physician or dental provider will notify the [appropriate referral agency], Tribal Police Department and the Social Services Department of their suspicions. Circumstances Requiring Investigation Frequent visits to the Emergency Department with un-explained injuries Evasion, contraindications and conflicting statements about circumstances involved; especially if marked discrepancies between clinical findings and historical data are elicited. Observation of the appearance of neglect Poor or malnutrition Multiple fractures or soft tissue injuries from any source including cigarette burns, or belt buckle origin Unexplained head injuries Dental Neglect Severe dental decay in a child will not in itself be considered neglect, unless other circumstances lead the dental provider to suspect overall neglect. However, if the parent/guardian is informed of the child’s dental treatment needs and fails to complete treatment available through the [Facility] dental clinic or through CHS within a reasonable time, dental neglect may be suspected and reported. If Abuse or Neglect is Suspected: Provide appropriate medical care for an injury or illness that may be present. Obtain a history from patient, parents or appropriate source. Obtain essential laboratory test or radiological exam deemed necessary by the provider. Contact the proper authorities Social Services [Phone #] County Dept. of Social Services [Phone #] 98 Describe Reporting and Follow Up Procedures Example: Dental providers will refer cases to Social Services for investigation. OR Dental providers will refer cases to Community Health Representatives to encourage parents tot keep dental appointments. If unsuccessful, cases will be referred to Social Services for further investigation. OR Dental providers will request an examination by the medical staff. The medical provider will admit the child to the hospital if it is deemed necessary for treatment or if, in their judgment, there is danger of the child being further mistreatment upon returning to the home. This also applies to the elderly. When a child under 18 years of age is brought to the Facility and appears to have been neglected, battered or sexually assaulted, it is the responsibility of any professional person to report the incident to the [appropriate referral agency] County Department of Social Services. The individual calling Social Services will have to give their name, but law when reporting such cases protects the individual. In reporting suspected events, give only factual information from your observation. The [Agency] is responsible for investigating and notifying a local law enforcement agency. The hospital may retain the temporary custody of the child by order of a physician or the Hospital Administrator. Documentation Provider will record all pertinent information in the patient’s health record. Patient information that should be recorded: Health History, physical examination, clinical observations, history of the injury provided by all parties, laboratory tests, radiographs, and photographs of the injury. (Radiographs must only be taken when medically necessary, and never for the sole purpose of separating parent/guardian from the child to conduct separate interviews.) See IHS Circular No. 64.7 (5 Mar 1982). 99 B.25 PATHOLOGY PURPOSE To establish a uniform method of performing, documenting, and informing patients of the results of tissue biopsy. PROCEDURE Brush Biopsy The dentist will perform the brush biopsy according to manufacturer’s instructions. Samples are then sent to the Brush Biopsy manufacturer for analysis. Results are reported to the patients by phone or my mail if unavailable by phone. Reports are maintained in the patient’s chart. Excisional Biopsy Form [form #] Tissue Examination form will be completed and submitted with the tissue to the Department of Pathology at the Bethesda Naval Dental Unit, Bethesda, MD [or other appropriate laboratory] When the report is returned from the pathologist, the dentist will initial the report and one copy will be filed in the patient’s medical/dental chart. Notation will be entered in the tissue specimen log located [in the dental clinic]. 100 B.26 CLINICAL ORAL DISEASE PREVENTION/HEALTH PROMOTION PURPOSE To establish clinical oral health promotion/disease prevention (HP/DP) procedures consistent with current science and Indian Health Service priorities. Definitions Open Access: patients are seen without an appointment as they present to the clinic. High risk groups: target groups with known high oral disease rates Patients of record: patients with a comprehensive dental examination within the last 3 years PROCEDURE. High Risk Groups High risk groups including [insert current high risk groups such as Head Start children, children age 0-3, diabetes patients] will have Open Access to the dental clinic for preventive services including [insert services such as screening, fluoride varnish, OHI, exams]. Patients of Record 1. Examination results of hard and soft tissues, periodontal status and needs, orthodontic needs, risk for caries and periodontal disease, and other prevention needs will be recorded at the comprehensive examination appointment. 2. Patients will be assessed for caries risk, periodontal status, risk for traumatic injury (sport activities), or other oral health risk at the examination appointments. Elevated risk status will be documented on the examination form. Treatment plans will be developed as appropriate for risk category. 3. Supplemental fluoride will be based on the following**: Revised 1994 Age Birth to 6 months 6 months to 3 years 3 years to 6 years Breast fed Fluoride Level (Home Water) Less than 0.3 0.3 – 0.6 ppm ppm 0* 0 0.25 0 0.5 0.25 1.0 0.5 Greater than 0.6 ppm 0 0 0 0 *milligrams of fluoride per day 2.2 mg sodium fluoride = 1 mg fluoride (F ) ** Jointly endorsed by: American Academy of Pediatric Dentistry American Dental Association American Academy of Pediatrics 101 Patient’s home water supply will be tested for fluoride content prior to prescribing supplemental fluoride. Prescriptions will be refilled for a period of one year without further dental evaluation unless that patient changes addresses and water source. Sample: l mg. Fluoride daily #60 Refill 1 year 4 When fluoride rinse is indicated the patient will be given a recommendation for an overthe-counter daily rinse. It will be necessary for the patient to obtain the rinse at his/her own expense. Fluoride rinse will be used only for clients six (6) years or older. Moderate or high risk patients who cannot use a home rinse will receive fluoride varnish treatments appropriate to their risk category. 5 Unless medically contraindicated, all dentate dental patients will be advised to use fluoride toothpaste. 6 Topical fluoride may be applied using either a fluoride varnish or 1.23% acidulated phosphate gel. Patients considered moderate risk will be given a semi-annual topical fluoride treatment. Patients considered high risk will be given more frequent applications up to 4 treatments per year. Procedures: a. Gel: Topical fluoride application will consist of placing three pea size drops of fluoride gel on an upper disposable tray, three pea size drops of fluoride gel on a lower disposable tray, spreading these drops evenly over the tray surface, placing the tray over the teeth and allowing the tray to remain in place for four minutes. Patients will be instructed not to eat or drink for 30 minutes. B. Varnish: After removal of excessive plaque, teeth will be dried with 4x4 gauze, then varnish will be applied to all tooth surfaces. Patients should not drink hot liquids or eat for approximately 2 hours. 7 Teeth needing sealants will be marked with an "NS" on the examination form. Teeth with sealants in place will be marked with "S" on the examination form. Need for sealants will be based on caries risk. 8. Dietary counseling will be implemented for high risk patients. A referral shall be made to the clinic's nutritionist. Moderate risk patients will receive nutritional counseling by dental staff (coded D1310). All records of nutritional education and recommendations provided by dental staff will be maintained in the patient’s dental record. 9 CPITN (Community Periodontal Index Treatment Needs): Perio screening will be documented all new patients over the age of 12 for each sextant of the mouth based on the most severe pocket in the sextant. 10. Scaling will be done by the dentist or hygienist. All patients with type II and III periodontal status will receive appropriate periodontal services according to the IHS periodontal guidelines. 102 11 OHI will be re-evaluated at each subsequent dental visit. Appropriate educational services will be provided as needed. (e.g. Plaque removal, dietary instructions, completion of dental treatment plans, fluoride use, denture care.) 12 The patient will be informed of their periodontal status; if CPITN score is 3 or 4 the patient will be treated with non-surgical intervention and reassessed with recall appointments. Information on periodontal disease will be given to the patient. All education will be documented in the dental chart. 13 Patients age six to twenty (6 – 20) years will be informed of the need for orthodontic treatment, and that any orthodontic treatment will have to be at the patient’s or parent's expense 14. Patients who are at increased risk for caries or periodontal disease due to medical conditions will be given priority treatment. 15. Newly diagnosed diabetics or other special needs patients will be referred from the outpatient clinic. Upon receiving the referral an examination appointment will be given to the patients. At the first appointment the patient will be informed of the effect of diabetes on the oral tissues as well as receive the treatment given to all new patients. 16. Patients in a known high risk group may be included in community based prevention programs. In community based programs, all participants will receive identical services. Referrals will be based on individual risk assessment. 17. Recall intervals will be based on each patient’s risk category. Low Risk: 12 month recall Moderate Risk: 6-12 month recall High Risk: 2-3 month recall 103 B.27 NITROUS OXIDE PURPOSE To establish procedures for the safe and effective use of nitrous oxide in the Dental Clinic. PROCEDURE Patient Selection This facility adheres to the American Academy of Pediatric Dentistry (AAPD) guidelines for nitrous oxide. All sections of this policy will apply to patients of all ages. According to the AAPD’s 2005 guideline: The following are the patient selection and contraindication recommendations according to the American Academy of Pediatric Dentistry. If necessary, add any additional monitoring requirements of the facility. “Indications for use of nitrous oxide/oxygen analegesia/anxiolysis include: 1. a fearful, anxious or obstreperous patient 2. certain mentally, physically, or medically compromised patients 3. a patient whose gag reflex interferes with dental care 4. a patient for whom profound local anesthetic cannot be obtained 5. an uncooperative child undergoing a lengthy dental procedure Contraindications for Use of nitrous oxide/oxygen analgesia/anxiolysis 1. some chronic obstructive pulmonary diseases 2. severe emotional disturbances or drug related dependencies 3. first trimester of pregnancy 4. treatment with bleomycin sulfate” The patient’s medical provider must be consulted in cases with significant underlying medical conditions. Qualifications of Providers According to the AAPD’s 2009 Guideline, “The practitioner who utilized nitrous oxide anesthesia/analgesia for a pediatric dental patients shall possess appropriate training and skills and have available the proper facilities, personnel, and equipment to manage any reasonable foreseeable emergency. Training and certification in basic life support are required for all clinical personnel.” All dental providers using nitrous oxide must have a record stating that training was received in nitrous oxide. This will be filed [appropriate location]. Competency Describe procedures used to ensure provider competency, if any] Monitoring 104 According to the AAPD’s 2009 Guideline: If necessary, add any additional monitoring requirements of the facility. “The response of patients to commands during procedures performed with anxiolysis/analgesia serves as a guide to their level of consciousness. Clinical observation of the patient must be done during any dental procedure. During nitrous oxide/oxygen analgesia/anxiolysis, continual clinical observation of the patient’s responsiveness, color, and respiratory rate and rhythm must be performed. Spoken response provide an indication that the patient is breathing. If any other pharmacologic agent is used in addition to nitrous oxide/oxygen and a local anesthetic, monitoring guidelines for the appropriate level of sedation must be followed.” Documentation According to the AAPD’s 2009 Guideline: If necessary, add any additional monitoring requirements of the facility. “Informed consent must be obtained from the parent and documented in the patient’s record prior to the administration of nitrous oxide/oxygen. The practitioner should provide instructions to the parent regarding pretreatment dietary, if indicated. In addition, the patient’s record must include indication for use of nitrous oxide/oxygen inhalation, nitrous oxide dosage (ie. Percent of nitrous oxide/oxygen and/or flow rate), duration of the procedure, and posttreatment oxygenation procedures.” Equipment According to the AAPD’s 2009 Guideline, If necessary, add any additional monitoring requirements of the facility. “All newly installed facilities for delivering nitrous oxide/oxygen must be checked for proper gas delivery and fail safe function prior to use. Inhalation equipment must have the capacity for delivering 100% and never less than 30% oxygen concentration at a flow rate appropriate to the child’s size. Additionally, inhalation equipment must have a fail safe system that is checked and calibrated…” [inset manufacturer’s recommended calibration and maintenance schedule]. Nitrous Oxide scavenging mask and equipment must be working at the time of analgesia initiation. Nitrous Oxide equipment must be stored in a restricted area at all times when not in use. Maintenance of this equipment will be checked on a routine weekly inspection and before each usage. All rubber equipment will be checked for contaminated waste, and cracking. Back pressure will be tested for discovery of leaking hoses and manifolds. The scavenger system will always be utilized when administering nitrous oxide. The dental clinic will be locked at night and during the weekends to secure all nitrous oxide oxygen equipment. 105 The equipment, which is used to administer nitrous oxide-oxygen, should be checked weekly for gas leaks. Any hoses or bags that leak should be replaced. Each month, the hoses and bags will be checked. 106 B.28 CONSCIOUS SEDATION [if applicable for your clinic, Omit this section if Conscious Sedation is not used in the dental facility or retain only those procedures used in the facility] PURPOSE Pharmaco-sedation is a necessary adjunctive procedure for many dental procedures, most often for behavior management and/or surgical procedures. Specific training is required, and these guidelines are not meant to be a substitute for that training. Sedative techniques are subject to [accreditation agency, if applicable] review and facilities may restrict techniques for a variety of considerations. These guidelines are based on guidelines developed by the American Dental Association and the American Society of Anesthesiologists and the practitioner is urged to review the most recent guidelines. PROCEDURE The goals for the management of Pharmaco-sedation in the ambulatory patient are: Patient welfare Control of patient behavior Production of positive psychological response to treatment Return to pretreatment level of consciousness by time of discharge Definition of Terms For the purpose of this document the following definitions shall apply: ASA Classification: ASA stands for American Society of Anesthesiologists. In 1963 the ASA adopted a 5 category physical status classification system for assessing a patient before surgery. The first 4 classes are: 1) A normal healthy patient. 2) A patient with mild systemic disease. 3) A patient with severe systemic disease. 4) A patient with severe systemic disease that is a constant threat to life. Anxiolysis: A dissolution or reduction of anxiety through the use of the hypnotic dose of a sedative agent, i.e., light sedation Conscious Sedation: A drug induced depression of consciousness during which patients respond purposefully to verbal command, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Deep Sedation: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. 107 The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. . General Anesthesia: A drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. Moderate Sedation: Conscious sedation Nitrous Oxide/Oxygen Analgesia: The relative reduction of fear, anxiety, and pain response through the controlled delivery of nitrous oxide and oxygen through a dental inhalation sedation delivery system. Rescue: Rescue of a patient from a deeper level of sedation than intended is an intervention by a practitioner proficient in airway management and advanced life support. The qualified practitioner corrects adverse physiologic consequences of the deeper-than intended level of sedation (such as hypoventilation, hypoxia and hypotension) and returns the patient to the originally intended level of sedation. General Considerations Applicability: These guidelines should be considered as minimum guidelines. More stringent procedures may be required for individual patients. Practitioners. According to the ASA 2006 Guidelines, “Only physicians, dentists or podiatrists who are qualified by education, training and licensure to administer moderate sedation should supervise the administration of moderate sedation. Nonanesthesiologist sedation practitioners may directly supervise patient monitoring and the administration of sedative and analgesic medications by a supervised sedation professional. Alternatively, they may personally perform these functions, with the proviso that the individual monitoring the patient should be distinct from the individual performing the diagnostic or therapeutic procedure.” Local Anesthesia used in conjunction with pharmaco-sedation: All local anesthetic agents can become cardiac and central nervous system (CNS) depressants when administered in excessive doses. There is a potential interaction between local anesthetic and sedatives used in pediatric dentistry that can result in enhanced sedative effects and/or untoward events; therefore, particular attention should be paid to doses used in children. To avoid excessive doses, a maximum recommended dose in mg/kg or mg/lb. should be calculated for each patient and recorded prior to administration for all sedatives and local anesthetics used. (Table 1) Candidates: A preoperative physical examination should be completed the day of 108 treatment by a qualified practitioner for all patients undergoing sedation at levels deeper than anxiolysis. A medical consult may be appropriate. Patients who are ASA (American Society of Anesthesiologists) Class I or II may be considered candidates for conscious sedation or deep sedation. Patients in ASA Class III or IV present special problems and require individual consideration and should be treated in a hospital setting. General anesthesia requires consultation with an anesthesiologist, unless the person administering the general anesthesia has been adequately trained and privileged to assess the patient. Responsible Adult: The pediatric patient should be accompanied to and from the treatment facility by a parent, legal guardian, or other responsible adult who should be required to remain at the treatment facility for the entire treatment period. A responsible adult must accompany adult patients who receive moderate, deep or general anesthesia. An adult who receives only nitrous oxide/oxygen or local anesthesia need not be accompanied by another adult. Education and Training This facility adheres to the American Society of Anesthesiologist (ASA) guidelines for education and training for nonanesthesiologist sedation practitioners. According to the ASA’s 2006 guidelines: “The nonanesthesiologist sedation practitioner who is to supervise or personally administer medications for moderate sedation should have satisfactorily completed a formal training program in: (1) the safe administration of sedative and analgesic drugs used to establish a level of moderate sedation, and (2) rescue of patients who exhibit adverse physiologic consequences of a deeper-than-expected level of sedation. This training may be a part of a recently completed residency or fellowship training (e.g. within two years), or may be a separate educational program. A knowledge-based test may be used to verify the practitioner’s understanding of these concepts. The following subject areas should be included: 1) Contents of the following ASA documents that should be understood by practitioners who administer sedative and analgesic drugs to establish a level of moderate sedation: a. Practice Guidelines for Sedation and Analgesia by Nonanesthesiologists b. Continuum of Depth of Sedation—Definition of General Anesthesia and Levels of Sedation/Analgesia 2) Appropriate methods for obtaining informed consent through pre-procedure counseling of patients regarding risks, benefits, and alternatives to the administration of sedative and analgesic drugs to establish a level of moderate sedation. 3) Skills for obtaining the patient’s medical history and performing a physical examination to assess risks and co-morbidities, including assessment of the airway for anatomic and mobility characteristics suggestive of potentially difficult airway management. The nonanesthesiologist sedation practitioner should be able to recognize those patients whose medical condition suggests that sedation should be provided by an anesthesia professional. 4) Assessment of the patient’s risk for aspiration of gastric contents as described the ASA Practice Guidelines for Preoperative Fasting: ‘In urgent, emergent or other situations where gastric emptying is impaired, the potential for pulmonary aspiration of gastric contents must be considered in determining (1) the target level of sedation, (2) whether 109 the procedure should be delayed or (3) whether the trachea should be protected by intubation.’ 5) The pharmacology of (1) all sedative and analgesic drugs the practitioner requests privileges to administer to establish a level of moderate sedation, (2) pharmacological antagonists to the sedative and analgesic drugs and (3) vasoactive drugs and antiarrhythmics. 6) The benefits and risks of supplemental oxygen. 7) Proficiency of airway management with facemask and positive pressure ventilation. This training should include appropriately supervised experience in managing the airway of patients, or qualified instruction on an airway simulator (or both). 8) Monitoring of physiologic variables, including the following: a. Blood pressure b. Respiratory rate c. Oxygen saturation by pulse oximetry d. Electrocardiographic monitoring. Education in electrocardiographic (EKG) monitoring should include instruction in the most common arrythmias seen during sedation and anesthesia, their causes and their potential clinical implications (e.g. hypercapnia), as well as electrocardiographic signs of cardiac ischemia. e. Depth of sedation. The depth of sedation should be based on the ASA definitions of ‘moderate sedation’ and ‘deep sedation’. (See above) f. Capnography—if moderate sedation is to be administered in settings where patients’ ventilatory functions cannot be directly monitored (e.g. MRI suite). 9) The importance of continuous use of appropriately set audible alarms on physiologic monitoring equipment. 10) Documenting the drugs administered, the patient’s physiologic condition and the depth of sedation at regular intervals throughout the period of sedation and analgesia, using a graphical, tabular or automated record. 11) If moderate sedation is to be administered in a setting where individual(s) with advanced life support skills will not be immediately available (1-5 minutes; e.g., code team), then the nonanesthesiologist sedation practitioner should have advanced life support skills such as those required for American Heart Association certification in Advanced Cardiac Life Support (ACLS). When granting privileges to administer moderate sedation to pediatric patients, the nonanesthesiologist sedation practitioner should have advanced life support skills such as those required for certification in Pediatric Advanced Life Support (PALS). When the practitioner is being granted privileges to administer sedative and analgesic drugs to pediatric patients to establish a level of moderate sedation, the education and training requirements enumerated in #1-9 above should be appropriately tailored to qualify the practitioner to administer sedative and analgesic drugs to pediatric patients.” An individual trained and competent in the monitoring of sedated patients shall appropriately monitor any patient given a sedating agent in the clinic. Administration of agents with patients returning to the waiting room for onset of sedation is not acceptable. No medications for moderate or deeper levels of sedation should be administered outside of the clinical setting. Supplemental oxygen is recommended for all sedated patients (not including anxiolysis). Competency 110 Providers should demonstrate current competence via [insert facility’s competency evaluation procedures] Table 1 Local Anesthetic Dosages Generic Name Brand Name Lidocaine Mepivacaine Mepivacaine Prilocaine Bupivacaine Xylocaine Carbocaine Carbocaine Citanest Marcaine Max. Rec. Conc. (%) 2 2 3 4 0.5 Dose (Mg/Kg) 4.4 6.6 6.6 7.9 2.0 Mg per Carpule 36 36 54 72 9 Facilities Medical support: The Dental Supervisor and the Clinical Director may limit the use and type of dental sedation performed based upon the availability of medical support. Utilization of some sedation techniques, e.g., IV sedation techniques, may require the prior notification of a physician present in the facility to assure that adequate medical support is available. Staffing: The staff required to safely conduct a sedation procedure will vary with the technique used. (See education and training section above) Armamentarium: Basic emergency diagnostic and treatment equipment and an emergency drug kit must be readily available. This should include the following: sphygmomanometer, stethoscope, oxygen source, positive pressure ventilator, adequate suction apparatus with tonsillar suction tip, oral and nasal airways, and IV kits. The equipment and supplies should be appropriate for both pediatric and adult patients. If narcotic drugs are administered, Naloxone must be available in the emergency drug kit. If Midazolam is administered, flumazanil (reversal agent) must be available. An Automated External Defibrillator will be available. Additionally, strong consideration should be given to having a crash cart. Nitrous Oxide: See Section B.22. Emergency Services Back-up emergency services should be identified. See Section B-18 (Medical Emergencies in the Dental Clinic). Documentation Prior to Treatment 111 The practitioner must document each sedation procedure in the patient's record. Documentation should include the following: Informed consent: Each patient, parent, or other responsible individual is required to be informed regarding benefits, risks, and alternatives to sedation and to give consent. The patient record should document that appropriate informed consent was obtained according to the procedures of the facility. (See Section B.12.—Informed Consent) Instructions to parents or responsible individual: The practitioner should provide verbal and written instructions to the parents or responsible individual. Instructions should be explicit and include an explanation of pre- and post-sedation dietary precautions, potential or anticipated postoperative behavior, and limitation of activities. Dietary precautions: The administration of sedative drugs should be preceded by an evaluation of the patient's food and fluid intake. Intake of food and liquids should be as follows: (a) no milk or solids after midnight prior to scheduled procedure; (b) clear liquids up to 4 hr. before procedure for children ages 6 months to 3 years; (c) clear liquids up to 6 hr. before procedure for children ages 3 to 6 years; and (d) clear liquids up to 8 hr. before procedure for children aged 7 years or greater. No restrictions are necessary for anxiolysis or nitrous oxide/oxygen sedation. Preoperative health evaluation: Prior to the administration of sedatives, the practitioner should obtain and document information about the patient's current health status as detailed in the following sections concerning the various sedation modalities. Patient immobilization: See Section B.11. Prescriptions: See Section B. 14. General Requirements for the Monitoring and Documentation for Oral and Parental Conscious Sedation and Deep Sedation The patient should be monitored from the time of drug delivery until discharge. Vital signs: The patient's record should contain documentation of intermittent quantitative monitoring and recording of oxygen saturation (pulse oximetry), heart and respiratory rates, and blood pressure, as recommended for specific sedation techniques. Responsiveness of the patient should be monitored at specific intervals before and during the procedure and until the patient is discharged. Drugs: The patient's record should document the name, dose and route, site, and time of administration of all drugs administered. The maximum recommended dose per kilogram or pound should be calculated and the actual dose given shall be documented in appropriate units (e.g., fentanyl is administered in microgram doses, not milligrams). The concentrations flow rate, and duration of administration of oxygen and nitrous oxide should be documented. Patient immobilization: See Section B. 11. 112 The condition of the patient and the time of discharge from the treatment facility should be documented in the record. Documentation should include that appropriate discharge criteria have been met. The record should also identify the responsible adult to whose care the patient was discharged. (Table 2) 113 Table 2: The Modified Aldrete Scoring System for Determining when Patients are Ready for Discharge from the PACU. A Score = 9 was Considered Necessary for Discharge Activity: Able to move voluntarily or on command 4 extremities 2 2 extremities 1 0 extremities 0 Respiration Able to deep breathe and cough freely 2 Dyspnoea, shallow or limited breathing 1 Apnoeic 0 Circulation BP +/- 20 mm of pre anaesthetic level 2 BP +/- 20 to 50 mm of pre anaesthesia level 1 BP +/- 50 mm of pre anaesthesia level 0 Consciousness Fully awake 2 arousable on calling 1 not responding 0 O2 Saturation Able to maintain O2 saturation>92% on room air 2 Needs O2 inhalation to maintain O2 saturation>90% 1 O2 saturation<90% even with O2 supplementation 0 Aldrete JA The post anaesthesia recovery score revisited. (Letter) J. Clin. Anesth. (7) 1995 89-91 114 Sedation Techniques, Specific Criteria Anxiolysis Training -Documentation of training and pharmacology in the form of dental school transcripts or a letter attesting to training from the institution. Where anxiolysis was not taught, training should be [requirements according to IHS guidelines or State dental practice act]. Staffing -No additional staffs beyond those needed for the routine dental procedure are required Armamentarium -No additional armamentarium beyond the normal dental procedure set-up is required Pre-op evaluation -Only a review of the dental medical history form is required. Monitoring -No additional monitoring beyond visual and verbal monitoring is required Documentation -Documentation should include drug and dose used and its effectiveness. Moderate Sedation Training See Education and Training section above. -[Requirements according to State practice act, additional requirements of facility] Staffing -The dentist should have at least two dental assistants present for proper monitoring and support, one to assist in the dental procedure and one to monitor the patient. At least one assistant must be certified in basic life support. -The practitioner responsible for the treatment of the patient and/or the administration of drugs for conscious sedation must be appropriately trained in the use of such drugs and techniques, must provide for appropriate monitoring, and must be capable of managing any reasonably foreseeable complications. (See Education and Training section above) -In addition to the operating practitioner, an individual trained to monitor appropriate physiologic parameters and to assist in any supportive or resuscitation measures required should be present. Both individuals must have training in basic life support, should have specific assignments, and should have current knowledge of the emergency cart (kit) inventory. (See Education and Training section above) Armamentarium 115 -The operating facility used for the administration of conscious sedation should have available all facilities and equipment previously recommended. The minimum monitoring equipment for sedation shall be a pulse oximeter. A precordial/pretracheal stethoscope is highly desirable. ECG monitoring equipment should be considered but is not required. Pre-op evaluation -Health history -Review of systems -Vital signs, including heart rate, respiratory rate, and blood pressure. -Risk assessment (ASA guidelines) -Evaluation of airway patency -Evaluation of the respiratory and cardiac systems is needed Monitoring -Whenever drugs for conscious sedation are administered, the patient should be monitored continuously for responsiveness and airway patency. There should be continuous monitoring of oxygen saturation by pulse oximetry and of heart and respiratory rates. Respiratory rate alone may not be a reliable guide to oxygenation, especially when the rate is hard to determine and respirations are shallow. ECG monitoring is once again encouraged. A precordial/pretracheal stethoscope also may be used for obtaining additional information on heart and respiratory rates and for monitoring airway patency. Restraining devices should be checked periodically to prevent airway obstruction or chest restriction. The patient's head position should be checked frequently to ensure airway patency. A trained individual from the time the sedating agent is administered until discharge from the facility must constantly observe a sedated patient. Documentation -Oxygen saturation and heart and respiratory rates should be recorded intermittently on a time-based record throughout the procedure and until the patient is discharged. -After completion of the treatment procedures, vital signs should be recorded at specific intervals. Postoperative monitoring, of blood pressure, heart rate, pulse oximetry, and possibly ECG is prudent. The practitioner shall assess the patient's responsiveness and discharge the patient only when the appropriate discharge criteria have been met. General Anesthesia Policies and procedures for the provision of general anesthesia are the prerogative of the Medical Staff Committee or Anesthesia Department of the facility. The dental practitioner should make himself/herself aware of all applicable provisions. A qualified person on appropriate patients without medical consultation may administer General Anesthesia in an adequate facility, with provision for recovery. The dental practitioner will follow all Policies and Procedures of the facility regarding General Anesthesia. 116 SECTION C: ENVIRONMENT 117 C.1 INFECTION CONTROL Purpose: To establish policies and procedures to protect dental personnel from work related exposures to infectious diseases and to protect dental patients from exposures to infectious diseases resulting from dental treatment. Authority: 1. Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care settings-2003. MMWR 2003;52 (No. RR-17) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm 2. (Handpiece manufacturer name) recommendation for maintenance and sterilization of high speed and low speed handpieces 3. Atest manufacturer’s instructions 4. (Facility Name) infection control policies relating to ambulatory patient care 5. (Facility Name) safety policies relating to infection control 6. (Facility Name) personnel policies relating to infection control 7. HIPAA act of 1998 Procedure: 1. Policies are numbered as IC/D (Infection Control/ Dental). 2. All policies in the Dental Infection Control Policy Guide are consistent with manufacturer’s recommendations, CDC, IHS(if applicable), and (Facility Name) recommendations and regulations. 3. Authority for all policies can be located in one of the above listed sources 4. Whenever possible, policies will defer to (Facility name) wide policies. Specific questions should be directed to the (Facility Name) Safety Officer, the (Facility Name) Infection Control Officer, Medical Records Chief (HIPPA regulations), or other appropriate authorities at (Facility Name). 5. When updating policies and procedures, current authoritative sources should be referenced and if possible, copied and placed in this guide as a reference. 6. Guide should be updated annually or as soon as new recommendations become available 7. Copies of the Dental Infection Control Policy Guide will be maintained at (Facility(ies) Name(s)) 8. Periodic quality assurance studies will be conducted to ensure compliance with this guide. Lack of compliance or changes in procedures will be discussed at dental staff meetings. The Chief- Dental Services will approve changes to the guide prior to implementation 9. Recommendations may be classified by the following categories: 118 Category IA. Strongly recommended for implementation and strongly supported by welldesigned experimental, clinical, or epidemiologic studies. Category IB. Strongly recommended for implementation and supported by experimental, clinical, or epidemiologic studies and a strong theoretical rationale. Category IC. Required for implementation as mandated by federal or state regulation or standard. When IC is used, a second rating can be included to provide the basis of existing scientific data, theoretical rationale, and applicability. Because of state differences, the reader should not assume that the absence of a IC implies the absence of state regulations. Category II. Suggested for implementation and supported by suggestive clinical or epidemiologic studies or a theoretical rationale. Personnel Health Elements of of an Infection Control Program A. General Recommendations 1. Develop a written health program for DHCP that includes policies, procedures, and guidelines for education and training; immunizations; exposure prevention and postexposure management; medical conditions, work-related illness, and associated work restrictions; contact dermatitis and latex hypersensitivity; and maintenance of records, data management, and confidentiality (IB). 2. Establish referral arrangements with qualified health-care professionals to ensure prompt and appropriate provision of preventive services, occupationally related medical services, and postexposure management with medical follow-up (IB, IC). B. Education and Training 1. Provide DHCP 1) on initial employment, 2) when new tasks or procedures affect the employee's occupational exposure, and 3) at a minimum, annually, with education and training regarding occupational exposure to potentially infectious agents and infectioncontrol procedures/protocols appropriate for and specific to their assigned duties (IB, IC). 2. Provide educational information appropriate in content and vocabulary to the educational level, literacy, and language of DHCP (IB, IC). C. Immunization Programs 1. Develop a written comprehensive policy regarding immunizing DHCP, including a list of all required and recommended immunizations (IB). 2. Refer DHCP to a prearranged qualified health-care professional or to their own healthcare professional to receive all appropriate immunizations based on the latest recommendations as well as their medical history and risk for occupational exposure (IB). D. Exposure Prevention and Postexposure Management 1. Develop a comprehensive postexposure management and medical follow-up program (IB, IC). 119 a. Include policies and procedures for prompt reporting, evaluation, counseling, treatment, and medical follow-up of occupational exposures. b. Establish mechanisms for referral to a qualified health-care professional for medical evaluation and follow-up. c. Conduct a baseline TST, preferably by using a two-step test, for all DHCP who might have contact with persons with suspected or confirmed infectious TB, regardless of the risk classification of the setting (IB). E. Medical Conditions, Work-Related Illness, and Work Restrictions 1. Develop and have readily available to all DHCP comprehensive written policies regarding work restriction and exclusion that include a statement of authority defining who can implement such policies (IB). 2. Develop policies for work restriction and exclusion that encourage DHCP to seek appropriate preventive and curative care and report their illnesses, medical conditions, or treatments that can render them more susceptible to opportunistic infection or exposures; do not penalize DHCP with loss of wages, benefits, or job status (IB). 3. Develop policies and procedures for evaluation, diagnosis, and management of DHCP with suspected or known occupational contact dermatitis (IB). 4. Seek definitive diagnosis by a qualified health-care professional for any DHCP with suspected latex allergy to carefully determine its specific etiology and appropriate treatment as well as work restrictions and accommodations (IB). F. Records Maintenance, Data Management, and Confidentiality 1. Establish and maintain confidential medical records (e.g., immunization records and documentation of tests received as a result of occupational exposure) for all DHCP (IB, IC). 2. Ensure that the practice complies with all applicable federal, state, and local laws regarding medical recordkeeping and confidentiality (IC). Preventing Transmission of Bloodborne Pathogens A. HBV Vaccination 1. Offer the HBV vaccination series to all DHCP with potential occupational exposure to blood or other potentially infectious material (IA, IC). 2. Always follow U.S. Public Health Service/CDC recommendations for hepatitis B vaccination, serologic testing, follow-up, and booster dosing (IA, IC). 3. Test DHCP for anti-HBs 1--2 months after completion of the 3-dose vaccination series (IA, IC). 4. DHCP should complete a second 3-dose vaccine series or be evaluated to determine if they are HBsAg-positive if no antibody response occurs to the primary vaccine series (IA, IC). 5. Retest for anti-HBs at the completion of the second vaccine series. If no response to the second 3-dose series occurs, nonresponders should be tested for HBsAg (IC). 6. Counsel nonresponders to vaccination who are HBsAg-negative regarding their 120 susceptibility to HBV infection and precautions to take (IA, IC). 7. Provide employees appropriate education regarding the risks of HBV transmission and the availability of the vaccine. Employees who decline the vaccination should sign a declination form to be kept on file with the employer (IC). B. Preventing Exposures to Blood and OPIM 1. General recommendations a. Use standard precautions (OSHA's bloodborne pathogen standard retains the term universal precautions) for all patient encounters (IA, IC). b. Consider sharp items (e.g., needles, scalers, burs, lab knives, and wires) that are contaminated with patient blood and saliva as potentially infective and establish engineering controls and work practices to prevent injuries (IB, IC). c. Implement a written, comprehensive program designed to minimize and manage DHCP exposures to blood and body fluids (IB, IC). 2. Engineering and work-practice controls a. Identify, evaluate, and select devices with engineered safety features at least annually and as they become available on the market (e.g., safer anesthetic syringes, blunt suture needle, retractable scalpel, or needleless IV systems) (IC). b. Place used disposable syringes and needles, scalpel blades, and other sharp items in appropriate puncture-resistant containers located as close as feasible to the area in which the items are used (IA, IC). c. Do not recap used needles by using both hands or any other technique that involves directing the point of a needle toward any part of the body. Do not bend, break, or remove needles before disposal (IA, IC). d. Use either a one-handed scoop technique or a mechanical device designed for holding the needle cap when recapping needles (e.g., between multiple injections and before removing from a nondisposable aspirating syringe) (IA, IC). 3. Postexposure management and prophylaxis a. Follow CDC recommendations after percutaneous, mucous membrane, or nonintact skin exposure to blood or other potentially infectious material (IA, IC). Hand Hygiene A. General Considerations 1. Perform hand hygiene with either a nonantimicrobial or antimicrobial soap and water when hands are visibly dirty or contaminated with blood or other potentially infectious material. If hands are not visibly soiled, an alcohol-based hand rub can also be used. Follow the manufacturer's instructions (1A) 2. Indications for hand hygiene include a. when hands are visibly soiled b. after barehanded touching of inanimate objects likely to be contaminated by blood, saliva, or respiratory secretions (IA, IC); 121 c. before and after treating each patient (IB); d. before donning gloves (IB); and e. immediately after removing gloves (IB, IC) 3. For oral surgical procedures, perform surgical hand antisepsis before donning sterile surgeon's gloves. Follow the manufacturer's instructions by using either an antimicrobial soap and water, or soap and water followed by drying hands and application of an alcohol-based surgical hand-scrub product with persistent activity (IB) 4. Store liquid hand-care products in either disposable closed containers or closed containers that can be washed and dried before refilling. Do not add soap or lotion to (i.e., top off) a partially empty dispenser. B. Special Considerations for Hand Hygiene and Glove Use 1. Use hand lotions to prevent skin dryness associated with handwashing (IA). 2. Consider the compatibility of lotion and antiseptic products and the effect of petroleum or other oil emollients on the integrity of gloves during product selection and glove use (IB) 3. Keep fingernails short with smooth, filed edges to allow thorough cleaning and prevent glove tears (II) 4. Do not wear artificial fingernails or extenders when having direct contact with patients at high risk (e.g., those in intensive care units or operating rooms) (IA) 5. Use of artificial fingernails is usually not recommended (II) 6. Do not wear hand or nail jewelry if it makes donning gloves more difficult or compromises the fit and integrity of the glove (II) Personal Protective Equipment (PPE) A. Masks, Protective Eyewear, and Face Shields 1. Wear a surgical mask and eye protection with solid side shields or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures likely to generate splashing or spattering of blood or other body fluids (IB, IC). 2. Change masks between patients or during patient treatment if the mask becomes wet (IB). 3. Clean with soap and water, or if visibly soiled, clean and disinfect reusable facial protective equipment (e.g., clinician and patient protective eyewear or face shields) between patients (II). B. Protective Clothing 1. Wear protective clothing (e.g., reusable or disposable gown, laboratory coat, or uniform) that covers personal clothing and skin (e.g., forearms) likely to be soiled with blood, saliva, or OPIM (IB, IC). 2. Change protective clothing if visibly soiled; change immediately or as soon as feasible if penetrated by blood or other potentially infectious fluids (IB, IC). 3. Remove barrier protection, including gloves, mask, eyewear, and gown before 122 departing work area (e.g., dental patient care, instrument processing, or laboratory areas) (IC). C. Gloves 1. Wear medical gloves when a potential exists for contacting blood, saliva, OPIM, or mucous membranes (IB, IC). 2. Wear a new pair of medical gloves for each patient, remove them promptly after use, and wash hands immediately to avoid transfer of microorganisms to other patients or environments (IB). 3. Remove gloves that are torn, cut, or punctured as soon as feasible and wash hands before regloving (IB, IC). 4. Do not wash surgeon's or patient examination gloves before use or wash, disinfect, or sterilize gloves for reuse (IB, IC). 5. Ensure that appropriate gloves in the correct size are readily accessible (IC). 6. Use appropriate gloves (e.g., puncture- and chemical-resistant utility gloves) when cleaning instruments and performing housekeeping tasks involving contact with blood or OPIM (IB, IC). 7. Consult with glove manufacturers regarding the chemical compatibility of glove material and dental materials used (II). D. Sterile Surgeon's Gloves and Double Gloving During Oral Surgical Procedures 1. Wear sterile surgeon's gloves when performing oral surgical procedures (IB). 2. No recommendation is offered regarding the effectiveness of wearing two pairs of gloves to prevent disease transmission during oral surgical procedures. The majority of studies among HCP and DHCP have demonstrated a lower frequency of inner glove perforation and visible blood on the surgeon's hands when double gloves are worn; however, the effectiveness of wearing two pairs of gloves in preventing disease transmission has not been demonstrated (Unresolved issue). E. PPE Provided 1. (Facility name) will provide suitable gowns, eye protection, masks, gloves, hair covers, and shoe covers needed to provide dental treatment. F. Protection for Patients 1. Patients will be provided safety glasses to be worn throughout dental treatment. 2. When the introduction of minimal contaminants would compromise dental treatment, additional protection such as towel draped over the patient may be used. Contact Dermatitis and Latex Sensitivity 1. Educate DHCP regarding the signs, symptoms, and diagnoses of skin reactions associated with frequent hand hygiene and glove use (IB) 2. Screen all patients for latex allergy (e.g., take health history and refer for medical consultation when latex allergy is suspected) (IB) 3. Ensure a latex-safe environment for patients and DHCP with latex allergy (IB) 4. Have emergency treatment kits with latex-free products available at all times (II) 123 Sterilization and Disinfection of Patient-Care Items Definitions: Infection Control Categories of Patient-Care Instruments Category Critical Semicritical Noncritical Definition Penetrates soft tissues, contacts bone, enters into to contacts the blood stream or other normally sterile tissue. Contacts mucous membranes or nonintact skin; will not penetrate soft tissue, contact bone, enter into or contact the bloodstream or other normally sterile tissue. Contacts intact skin Dental Instrument or Item Surgical instruments, periodontal scalers, scalpel blades, surgical dental burs Dental mouth mirror, amalgam condenser, reusable dental impression trays, dental handpieces Radiograph head/cone, blood pressure cuff, facebow CDC, 2003, p. 20Levels of Sterilization and Disinfection Sterilization (autoclave)- used for heat-tolerant critical and semi-critical patient care items High-level disinfection- liquid immersion Intermediate-level disinfection- Liquid contact- EPA registered hospital disinfectant with lable claim of tuberculocidal activity (Chlorine containing products - 1:100 dilution (1/4 cup of 5.25% household chlorine bleach to 1 gallon of water) Alternative products may be biocide or Lysol-IC for surfaces that may be damaged by bleach products Low level disinfection- liquid contact- EPA registered disinfectant with no claim of tuberculocidal activity (soap and water, alcohol) CDC, 2003, p. 66 A. General Recommendations 1. Use only FDA-cleared medical devices for sterilization and follow the manufacturer's instructions for correct use (IB). 2. Clean and heat-sterilize critical dental instruments before each use (IA). 3. Clean and heat-sterilize semicritical items before each use (IB). 4. Allow packages to dry in the sterilizer before they are handled to avoid contamination (IB). 5. Use of heat-stable semicritical alternatives is encouraged (IB). 124 6. Reprocess heat-sensitive critical and semi-critical instruments by using FDA-cleared sterilant/high-level disinfectants or an FDA-cleared low-temperature sterilization method (e.g., ethylene oxide). Follow manufacturer's instructions for use of chemical sterilants/high-level disinfectants (IB). 7. Single-use disposable instruments are acceptable alternatives if they are used only once and disposed of correctly (IB, IC). 8. Do not use liquid chemical sterilants/high-level disinfectants for environmental surface disinfection or as holding solutions (IB, IC). 9. Ensure that . If visibly contaminated with blood, use an EPA-registered hospital disinfectant with a tuberculocidal claim (i.e., intermediate level) (IB). 10. Inform DHCP of all OSHA guidelines for exposure to chemical agents used for disinfection and sterilization. Using this report, identify areas and tasks that have potential for exposure (IC). B. Instrument Processing Area 1. Designate a central processing area. Divide the instrument processing area, physically or, at a minimum, spatially, into distinct areas for 1) receiving, cleaning, and decontamination; 2) preparation and packaging; 3) sterilization; and 4) storage. Do not store instruments in an area where contaminated instruments are held or cleaned (II). 2. Train DHCP to employ work practices that prevent contamination of clean areas (II). C. Receiving, Cleaning, and Decontamination Work Area 1. Minimize handling of loose contaminated instruments during transport to the instrument processing area. Use work-practice controls (e.g., carry instruments in a covered container) to minimize exposure potential (II). Clean all visible blood and other contamination from dental instruments and devices before sterilization or disinfection procedures (IA). 2. Use automated cleaning equipment (e.g., ultrasonic cleaner or washer-disinfector) to remove debris to improve cleaning effectiveness and decrease worker exposure to blood (IB). 3. Use work-practice controls that minimize contact with sharp instruments if manual cleaning is necessary (e.g., long-handled brush) (IC). 4. Wear puncture- and chemical-resistant/heavy-duty utility gloves for instrument cleaning and decontamination procedures (IB). 5. Wear appropriate PPE (e.g., mask, protective eyewear, and gown) when splashing or spraying is anticipated during cleaning (IC). D. Preparation and Packaging 1. Use an internal chemical indicator in each package. If the internal indicator cannot be seen from outside the package, also use an external indicator (II) . 2. Use a container system or wrapping compatible with the type of sterilization process used and that has received FDA clearance (IB). 125 3. Before sterilization of critical and semicritical instruments, inspect instruments for cleanliness, then wrap or place them in containers designed to maintain sterility during storage (e.g., cassettes and organizing trays) (IA). E. Sterilization of Unwrapped Instruments 1. Clean and dry instruments before the unwrapped sterilization cycle (IB). 2. Use mechanical and chemical indicators for each unwrapped sterilization cycle (i.e., place an internal chemical indicator among the instruments or items to be sterilized) (IB). 3. Allow unwrapped instruments to dry and cool in the sterilizer before they are handled to avoid contamination and thermal injury (II). 4. Semicritical instruments that will be used immediately or within a short time can be sterilized unwrapped on a tray or in a container system, provided that the instruments are handled aseptically during removal from the sterilizer and transport to the point of use (II). 5. Critical instruments intended for immediate reuse can be sterilized unwrapped if the instruments are maintained sterile during removal from the sterilizer and transport to the point of use (e.g., transported in a sterile covered container) (IB). 6. Do not sterilize implantable devices unwrapped (IB). 7. Do not store critical instruments unwrapped (IB). F. Sterilization Monitoring 1. Use mechanical, chemical, and biological monitors according to the manufacturer's instructions to ensure the effectiveness of the sterilization process (IB). 2. Monitor each load with mechanical (e.g., time, temperature, and pressure) and chemical indicators (II). 3. Place a chemical indicator on the inside of each package. If the internal indicator is not visible from the outside, also place an exterior chemical indicator on the package (II). 4. Place items/packages correctly and loosely into the sterilizer so as not to impede penetration of the sterilant (IB). 5. Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing (IB). 6. Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number) (IB). 7. Use a biological indicator for every sterilizer load that contains an implantable device. Verify results before using the implantable device, whenever possible (IB). 8. The following are recommended in the case of a positive spore test: a. Remove the sterilizer from service and review sterilization procedures (e.g., work practices and use of mechanical and chemical indicators) to determine whether operator error could be responsible (II). b. Retest the sterilizer by using biological, mechanical, and chemical indicators after correcting any identified procedural problems (II). c. If the repeat spore test is negative, and mechanical and chemical indicators are within normal limits, put the sterilizer back in service (II). 9. The following are recommended if the repeat spore test is positive: a. Do not use the sterilizer until it has been inspected or repaired or the exact reason for the positive test has been determined (II). 126 b. Recall, to the extent possible, and reprocess all items processed since the last negative spore test (II). c. Before placing the sterilizer back in service, rechallenge the sterilizer with biological indicator tests in three consecutive empty chamber sterilization cycles after the cause of the sterilizer failure has been determined and corrected (II) . 10. Maintain sterilization records (i.e., mechanical, chemical, and biological) in compliance with state and local regulations (IB) . G. Storage Area for Sterilized Items and Clean Dental Supplies 1. Implement practices on the basis of date- or event-related shelf-life for storage of wrapped, sterilized instruments and devices (IB). 2. Even for event-related packaging, at a minimum, place the date of sterilization, and if multiple sterilizers are used in the facility, the sterilizer used, on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure (IB). 3. Examine wrapped packages of sterilized instruments before opening them to ensure the barrier wrap has not been compromised during storage (II). 4. Reclean, repack, and resterilize any instrument package that has been compromised (II). 5. Store sterile items and dental supplies in covered or closed cabinets, if possible (II). Environmental Infection Control A. General Recommendations 1. Follow the manufacturers' instructions for correct use of cleaning and EPA-registered hospital disinfecting products (IB, IC). 2. Do not use liquid chemical sterilants/high-level disinfectants for disinfection of environmental surfaces (clinical contact or housekeeping) (IB, IC). 3. Use PPE, as appropriate, when cleaning and disinfecting environmental surfaces. Such equipment might include gloves (e.g., puncture- and chemical-resistant utility), protective clothing (e.g., gown, jacket, or lab coat), and protective eyewear/face shield, and mask (IC). B. Clinical Contact Surfaces 1. Use surface barriers to protect clinical contact surfaces, particularly those that are difficult to clean (e.g., switches on dental chairs) and change surface barriers between patients (II). 2. Clean and disinfect clinical contact surfaces that are not barrier-protected, by using an EPA-registered hospital disinfectant with a low- (i.e., HIV and HBV label claims) to intermediate-level (i.e., tuberculocidal claim) activity after each patient. Use an intermediate-level disinfectant if visibly contaminated with blood (IB). C. Housekeeping Surfaces 1. Clean housekeeping surfaces (e.g., floors, walls, and sinks) with a detergent and water or an EPA-registered hospital disinfectant/detergent on a routine basis, depending 127 on the nature of the surface and type and degree of contamination, and as appropriate, based on the location in the facility, and when visibly soiled (IB). 2. Clean mops and cloths after use and allow to dry before reuse; or use single-use, disposable mop heads or cloths (II). 3. Prepare fresh cleaning or EPA-registered disinfecting solutions daily and as instructed by the manufacturer. (II). 4. Clean walls, blinds, and window curtains in patient-care areas when they are visibly dusty or soiled (II). D. Spills of Blood and Body Substances 1. Clean spills of blood or OPIM and decontaminate surface with an EPA-registered hospital disinfectant with low- (i.e., HBV and HIV label claims) to intermediate-level (i.e., tuberculocidal claim) activity, depending on size of spill and surface porosity (IB, IC). E. Carpet and Cloth Furnishings 1. Avoid using carpeting and cloth-upholstered furnishings in dental operatories, laboratories, and instrument processing areas (II). F. Regulated Medical Waste 1. General Recommendations a. Develop a medical waste management program. Disposal of regulated medical waste must follow federal, state, and local regulations (IC). b. Ensure that DHCP who handle and dispose of regulated medical waste are trained in appropriate handling and disposal methods and informed of the possible health and safety hazards (IC). 2. Management of Regulated Medical Waste in Dental Health-Care Facilities a. Use a color-coded or labeled container that prevents leakage (e.g., biohazard bag) to contain nonsharp regulated medical waste (IC). b. Place sharp items (e.g., needles, scalpel blades, orthodontic bands, broken metal instruments, and burs) in an appropriate sharps container (e.g., puncture resistant, color-coded, and leakproof). Close container immediately before removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping (IC). c. Pour blood, suctioned fluids or other liquid waste carefully into a drain connected to a sanitary sewer system, if local sewage discharge requirements are met and the state has declared this an acceptable method of disposal. Wear appropriate PPE while performing this task (IC). Dental Waterlines, Biofilm, and Water Quality A. General Recommendations 1. Use water that meets EPA regulatory standards for drinking water (i.e., <500 CFU/mL of heterotrophic water bacteria) for routine dental treatment output water (IB, IC). 128 2. Consult with the dental unit manufacturer for appropriate methods and equipment to maintain the recommended quality of dental water (II). 3. Follow recommendations for monitoring water quality provided by the manufacturer of the unit or waterline treatment product (II). 4. Discharge water and air for a minimum of 20--30 seconds after each patient, from any device connected to the dental water system that enters the patient's mouth (e.g., handpieces, ultrasonic scalers, and air/water syringes) (II). 5. Consult with the dental unit manufacturer on the need for periodic maintenance of antiretraction mechanisms (IB). 6. Maintain a log of water line test results in the dental clinic. B. Boil-Water Advisories 1. The following apply while a boil-water advisory is in effect: a. Do not deliver water from the public water system to the patient through the dental operative unit, ultrasonic scaler, or other dental equipment that uses the public water system (IB, IC). b. Do not use water from the public water system for dental treatment, patient rinsing, or handwashing (IB, IC). c. For handwashing, use antimicrobial-containing products that do not require water for use (e.g., alcohol-based hand rubs). If hands are visibly contaminated, use bottled water, if available, and soap for handwashing or an antiseptic towelette (IB, IC). 2. The following apply when the boil-water advisory is cancelled: a. Follow guidance given by the local water utility regarding adequate flushing of waterlines. If no guidance is provided, flush dental waterlines and faucets for 1--5 minutes before using for patient care (IC). b. Disinfect dental waterlines as recommended by the dental unit manufacturer (II). Special Considerations A. Dental Handpieces and Other Devices Attached to Air and Waterlines 1. Clean and heat-sterilize handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units between patients (IB, IC). 2. Follow the manufacturer's instructions for cleaning, lubrication, and sterilization of handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units (IB). 3. Do not surface-disinfect, use liquid chemical sterilants, or ethylene oxide on handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units (IC). 4. Do not advise patients to close their lips tightly around the tip of the saliva ejector to evacuate oral fluids (II). 129 B. Dental Radiology 1. Wear gloves when exposing radiographs and handling contaminated film packets. Use other PPE (e.g., protective eyewear, mask, and gown) as appropriate if spattering of blood or other body fluids is likely (IA, IC). 2. Use heat-tolerant or disposable intraoral devices whenever possible (e.g., film-holding and positioning devices). Clean and heat-sterilize heat-tolerant devices between patients. At a minimum, high-level disinfect semicritical heat-sensitive devices, according to manufacturer's instructions (IB). 3. Transport and handle exposed radiographs in an aseptic manner to prevent contamination of developing equipment (II). 4. The following apply for digital radiography sensors: a. Use FDA-cleared barriers (IB). b. Clean and heat-sterilize, or high-level disinfect, between patients, barrierprotected semicritical items. If the item cannot tolerate these procedures then, at a minimum, protect with an FDA-cleared barrier and clean and disinfect with an EPA-registered hospital disinfectant with intermediate-level (i.e., tuberculocidal claim) activity, between patients. Consult with the manufacturer for methods of disinfection and sterilization of digital radiology sensors and for protection of associated computer hardware (IB). C. Aseptic Technique for Parenteral Medications 1. Do not administer medication from a syringe to multiple patients, even if the needle on the syringe is changed (IA). 2. Use single-dose vials for parenteral medications when possible (II). 3. Do not combine the leftover contents of single-use vials for later use (IA). 4. The following apply if multidose vials are used: a. Cleanse the access diaphragm with 70% alcohol before inserting a device into the vial (IA). b. Use a sterile device to access a multiple-dose vial and avoid touching the access diaphragm. Both the needle and syringe used to access the multidose vial should be sterile. Do not reuse a syringe even if the needle is changed (IA). c. Keep multidose vials away from the immediate patient treatment area to prevent inadvertent contamination by spray or spatter (II). d. Discard the multidose vial if sterility is compromised (IA). 5. Use fluid infusion and administration sets (i.e., IV bags, tubings and connections) for one patient only and dispose of appropriately (IB). D. Single-Use (Disposable) Devices 1. Use single-use devices for one patient only and dispose of them appropriately (IC). E. Preprocedural Mouth Rinses 1. No recommendation is offered regarding use of preprocedural antimicrobial mouth rinses to prevent clinical infections among DHCP or patients. Although studies have 130 demonstrated that a preprocedural antimicrobial rinse (e.g., chlorhexidine gluconate, essential oils, or povidone-iodine) can reduce the level of oral microorganisms in aerosols and spatter generated during routine dental procedures and can decrease the number of microorganisms introduced in the patient's bloodstream during invasive dental procedures, the scientific evidence is inconclusive that using these rinses prevents clinical infections among DHCP or patients (see discussion, Preprocedural Mouth Rinses) (Unresolved issue). F. Oral Surgical Procedures 1. The following apply when performing oral surgical procedures: a. Perform surgical hand antisepsis by using an antimicrobial product (e.g., antimicrobial soap and water, or soap and water followed by alcohol-based hand scrub with persistent activity) before donning sterile surgeon's gloves (IB). b. Use sterile surgeon's gloves (IB). c. Use sterile saline or sterile water as a coolant/irrigatant when performing oral surgical procedures. Use devices specifically designed for delivering sterile irrigating fluids (e.g., bulb syringe, single-use disposable products, and sterilizable tubing) (IB). G. Handling of Biopsy Specimens 1. During transport, place biopsy specimens in a sturdy, leakproof container labeled with the biohazard symbol (IC). 2. If a biopsy specimen container is visibly contaminated, clean and disinfect the outside of a container or place it in an impervious bag labeled with the biohazard symbol, (IC). H. Handling of Extracted Teeth 1. Dispose of extracted teeth as regulated medical waste unless returned to the patient (IC). 2. Do not dispose of extracted teeth containing amalgam in regulated medical waste intended for incineration (II). 3. Clean and place extracted teeth in a leakproof container, labeled with a biohazard symbol, and maintain hydration for transport to educational institutions or a dental laboratory (IC). 4. Heat-sterilize teeth that do not contain amalgam before they are used for educational purposes (IB). I. Dental Laboratory 1. Use PPE when handling items received in the laboratory until they have been decontaminated (IA, IC) 2. Before they are handled in the laboratory, clean, disinfect, and rinse all dental prostheses and prosthodontic materials (e.g., impressions, bite registrations, occlusal rims, and extracted teeth) by using an EPA-registered hospital disinfectant having at least an intermediate-level (i.e., tuberculocidal claim) activity (IB). 131 3. Consult with manufacturers regarding the stability of specific materials (e.g., impression materials) relative to disinfection procedures (II). 4. Include specific information regarding disinfection techniques used (e.g., solution used and duration), when laboratory cases are sent off-site and on their return (II). 5. Clean and heat-sterilize heat-tolerant items used in the mouth (e.g., metal impression trays and face-bow forks) (IB). 6. Follow manufacturers' instructions for cleaning and sterilizing or disinfecting items that become contaminated but do not normally contact the patient (e.g., burs, polishing points, rag wheels, articulators, case pans, and lathes). If manufacturer instructions are unavailable, clean and heat-sterilize heat-tolerant items or clean and disinfect with an EPA-registered hospital disinfectant with low- (HIV, HBV effectiveness claim) to intermediate-level (tuberculocidal claim) activity, depending on the degree of contamination (II). J. Laser/Electrosurgery Plumes/Surgical Smoke 1. No recommendation is offered regarding practices to reduce DHCP exposure to laser plumes/surgical smoke when using lasers in dental practice. Practices to reduce HCP exposure to laser plumes/surgical smoke have been suggested, including use of a) standard precautions (e.g., high-filtration surgical masks and possibly full face shields) (437); b) central room suction units with in-line filters to collect particulate matter from minimal plumes; and c) dedicated mechanical smoke exhaust systems with a highefficiency filter to remove substantial amounts of laser-plume particles. The effect of the exposure (e.g., disease transmission or adverse respiratory effects) on DHCP from dental applications of lasers has not been adequately evaluated (see previous discussion, Laser/Electrosurgery Plumes or Surgical Smoke) (Unresolved issue). K. Mycobacterium tuberculosis 1. General Recommendations a. Educate all DHCP regarding the recognition of signs, symptoms, and transmission of TB (IB). b. Conduct a baseline TST, preferably by using a two-step test, for all DHCP who might have contact with persons with suspected or confirmed active TB, regardless of the risk classification of the setting (IB). c. Assess each patient for a history of TB as well as symptoms indicative of TB and document on the medical history form (IB). d. Follow CDC recommendations for 1) developing, maintaining, and implementing a written TB infection-control plan; 2) managing a patient with suspected or active TB; 3) completing a community risk-assessment to guide employee TSTs and follow-up; and 4) managing DHCP with TB disease (IB). 2. The following apply for patients known or suspected to have active TB: a. Evaluate the patient away from other patients and DHCP. When not being evaluated, the patient should wear a surgical mask or be instructed to cover mouth and nose when coughing or sneezing (IB). b. Defer elective dental treatment until the patient is noninfectious (IB). 132 c. Refer patients requiring urgent dental treatment to a previously identified facility with TB engineering controls and a respiratory protection program (IB). L. Creutzfeldt-Jakob Disease (CJD) and Other Prion Diseases 1. No recommendation is offered regarding use of special precautions in addition to standard precautions when treating known CJD or vCJD patients. Potential infectivity of oral tissues in CJD or vCJD patients is an unresolved issue. Scientific data indicate the risk, if any, of sporadic CJD transmission during dental and oral surgical procedures is low to nil. Until additional information exists regarding the transmissibility of CJD or vCJD during dental procedures, special precautions in addition to standard precautions might be indicated when treating known CJD or vCJD patients; a list of such precautions is provided for consideration without recommendation (see Creutzfeldt-Jakob Disease and Other Prion Diseases) (Unresolved issue). Program Evaluation 1. Establish routine evaluation of the infection-control program, including evaluation of performance indicators, at an established frequency (II). 2. Monitoring Tool is included in the Quality Assurance Section 133 C.2 RADIOLOGICAL PROTECTION PURPOSE To establish procedures that ensure the safe operation of all radiology equipment, minimize radiation exposure to both patients and dental staff, and comply with State regulations. PROCEDURE Appropriate lead aprons will be placed over the patient for all radiographs. Lead aprons will be stored hanging; they will not be folded or creased when not in use, as this will increase the risk of holes or tears in the lead shield. Every year all lead aprons used for x-ray protection will be sent to [appropriate location] for evaluation. All aprons, which fail the inspection, will be discarded. Records of testing will be maintained by [appropriate staff]. [If the facility uses a monitoring service] Each staff member shall be shown the radiation detection report each quarter that it is issued. Each staff member will initial the report and the [appropriate staff] will keep a copy on file. "X-ray", will be loudly announced before any staff member begins to take any radiograph. This announcement will serve to inform all personnel in the area to stand clear of the path of the radiation beam. The operator will also inform patients who are moving to and from the operatories to stand clear of the path of the x-ray beam. All radiographs will be taken using a film positioner. At no time will a patient hold a film to position that film during x-ray exposure. A conspicuous sign shall be posted in the panoramic x-ray area announcing to all personnel that "WARNING! PERSONNEL SHOULD NOT BE IN THIS AREA DURING X-RAY USE". [Insert competency procedure} Example: The dental assistants shall yearly be evaluated on their clinical radiographs and radiological safety according to the IHS radiological criteria for quality care. X-Ray Machine Certification Insert appropriate State regulations and procedures 134 C.3 EQUIPMENT MAINTENANCE AND PRODUCT RECALLS PURPOSE To establish procedures that ensure the safe operation of all equipment, comply with facility safety policies, and comply with applicable State and federal regulations. PROCEDURE Maintenance Each dental unit will have a logbook pertaining to maintenance. Any maintenance that is required is entered into the book for that particular unit. The [appropriate individual] for maintenance required will check the logbooks weekly. If maintenance is required the [designated individual] will complete the necessary maintenance requests, refer them to [appropriate source for repairs such as :bio-medical engineering or refer them to maintenance personnel]. The [designated individual] will initial the logbook as the maintenance is completed. Should the bio-medical engineering be contacted, they will check the equipment and note in the logbook their findings. When the equipment is repaired the engineer will note the repair in the log. Alternative Procedure A contracted vendor makes quarterly maintenance visits. The vendor shall provide a copy of maintenance performed for each dental unit and the [designated individual] will maintain these records. Product Recalls When the dental department receives notice that a product is subject to a recall [designated individual] will check lot numbers, serial numbers or other product designators, gather all affected products, and comply with manufacturer’s instructions regarding the recall. 135 C.4 NITROUS OXIDE SAFETY PURPOSE To establish procedures for the safe and effective use of nitrous oxide/oxygen therapy to protect patients and facility employees. PROCEDURE The following National Institute for Occupational Safety and Health recommendations will be observed when using nitrous oxide/oxygen. System maintenance Inspect and maintain the anesthetic delivery system to prevent N2O leaks in all hoses, connections and fittings. Repair all leaks immediately. Ventilation Scavenging system used will maintain a flow rate of 45 LPM, measured by a calibrated flow device, and vented outdoors. Work Practices Select scavenging masks of proper size to fit patients. Prudent use of N2O to appropriately sedate patients is encouraged. Monitor the air concentration of N2O to insure Controls are effective in achieving low levels during dental operations. STEP BY STEP APPROACH FOR CONTROLLING N2O Step Procedure Control 1 Visually inspect all N2O equipment Replace defective equipment and/or parts. (reservoir bag, hoses, mask, connectors) for worn parts, cracks, holes, or tears. 2 Turn on the N2O tank and check all high to low pressure connections for leaks. Use a non-oil-based soap worn solution to check for bubbles at high pressure connectors, or use a portable infrared gas analyzer. Determine leak source and fix. If tank valve leaks, replace tank; if O-rings, gaskets, valves, hoses, or fittings, replace. Contact the manufacturer for parts tact the manufacturer for parts replacement. For threaded pipe fittings, use Teflon tape. Do not use this tape on compression fittings. 3 Select scavenging system and mask. Mask should come in various sizes to patients. Scavenging systems should operate Provide a range of mask sizes for patients. Check to see that noise levels at the mask are acceptable when the scavenging system exhaust rate is operated at 45 lpm. 136 at air flow rate of 45 lpm. 4 Connect mask to hose and turn on vacuum pump before turning on N2O. Scavenging system vacuum pump must have capacity to scavenge 45 lpm per dental operation. Determine proper vacuum pump size for maintaining 45 lpm flowrates, especially when interconnected with other dental scavenging systems. If undersized, replace pump. 5 Place mask on patient and assure a good, comfortable fit. Make sure reservoir bag is not over or under inflated while the patient is breathing. Secure mask with "slip" ring Secure mask with "slip" ring for "good activity" from patient breathing. 6 Check general ventilation for good room air mixing. Exhaust vents should not be close to air supply vents (use smoke tubes to observe air movement in room.) If smoke from smoke tubes indicate room air mixing is poor, then increase the airflow or redesign. If exhaust vents are close to air supply vents, relocate (check with ventilation engineers to make adjustments). 7 Conduct personal sampling of dentist and dental assistant for N2O exposure. Use diffusive sampler or infrared gas analyzer (see sampling methods). If personal exposures exceed 150 ppm during administration, improve mask fit and make sure it is secure over the patient's nose. Minimize patient talking while N2O is administered. 8 Repeat procedure in step 7. If personal exposures are less than 150 ppm but greater than 25 ppm, implement auxiliary exhaust ventilation near the patient's mouth. Capture distance should no greater than 10 inches from the patient's nose and mouth area and exhaust no less than 250 cfm at the hood opening. Avoid getting between the auxiliary exhaust hood and patient's mouth and nose area. 137 C.5 FIRE PLAN [Insert facility’s Policy Header Information] PURPOSE To establish procedures that ensure the safe evacuation in case of a fire, minimize risk of injury to both patients and dental staff, and comply with facility safety regulations. PROCEDURE FIRE EVACUATION PLAN The dental clinic will comply with all Fire Procedures set by the [Facility] Health Department. A copy of the [Facility] Fire Plan is located [location]. The evacuation of the dental clinic in care of fire is outlined in the Facility’s Fire and Safety Manual. A map of primary and secondary escape routes is posted [state location(s)]. All staff will become familiar with this map and evacuation procedures. A copy of the evacuation plan is located in the [location]. There are assigned locations of specific dental personnel as described in the plan When a fire is discovered in the dental area the person discovering the fire will [insert appropriate procedures]. If a fire is announced in another part of the facility [insert facility policies regarding response and evacuation procedures] Patients in the area will be moved out of the fire area following the primary exit. If that exit is not accessible, the secondary route will be used. All dental staff and dental patients will gather [state primary gathering location] to facilitate accounting for all persons present in the dental clinic at the time of the evacuation. 138 C.5 MERCURY HYGIENE PURPOSE To establish procedures that ensure the recycling of products containing mercury, minimize mercury exposure to both patients and dental staff, and comply with State regulations. PROCEDURE Dentists and their staff use certain toxic substances that may lead to the contamination of water systems and the environment. In order to prevent contamination, dental offices should implement proper waste management procedures. Subsequently Indian Health Service (IHS) has developed waste management guidelines for the use of mercury amalgam. Dental amalgam can contain up to 50 percent mercury. Although mercury in amalgam form is very stable, it should not be disposed of or rinsed down the drain. This is important because the amalgam waste could end up in municipal garbage, medical waste, or in the sewer system. If the waste is incinerated the mercury could be released to the environment, and if it reaches the sewer system it could contaminate drinking water or accumulate in fish. The best method of dealing with amalgam waste is by recycling it. Mercury can be recovered through a distillation process and reused in other products. If required by State regulations: “Amalgam waste will be collected using amalgam separators in wastewater.” The following document summarizes the different types of mercury amalgam wastes, management practices for dealing with amalgam waste that conform to IHS guidelines, and some Do’s and Don’ts when dealing with amalgam waste as outlined by the American Dental Association (ADA). Types of Amalgam Wastes Non-contact amalgam (scrap): Excess mixture that is left over after a dental procedure. Contact amalgam: Amalgam that has been in contact with the patient. Examples include extracted teeth with amalgam restorations, carving scrap collected at the chair, and amalgam captured by the chair side traps, filters or screens. Chair side traps: Amalgam that is captured during amalgam placement or removal procedures. Vacuum pump filters: Filters and traps contain amalgam sludge or water. Some recyclers will accept whole filters, while others may require special handling requirements for this material. Amalgam sludge: This is a mixture of liquid and solid material collected within the vacuum pump filters. Empty amalgam capsules: Amalgam that may be left over in the capsules after mixing the precapsulated dental amalgam. 139 Amalgam Waste Management Practices Scrap Amalgam Handling Dental scrap amalgam should be collected and stored in two designated, air-tight, widemouthed plastic containers. One should be labeled CONTACT AMALGAM (amalgam that has been in contact with the patient’s mouth), and the other should be labeled NONCONTACT AMALGAM. NOTE: some recyclers may require special handling requirements for extracted teeth such as shipping the tooth in a disinfectant. Make sure that the container lid is tightly sealed. Amalgam Capsule Handling Stock capsules in a variety of different sizes. After mixing the amalgam, place the empty capsules in a wide-mouthed, airtight container that is labeled AMALGAM CAPSULE WASTE. Capsules that cannot be emptied should also be placed in containers labeled AMALGAM CAPSULE WASTE. Make sure that the container lid is tightly sealed. Disposable chair-side traps Open the chair-side unit to expose the trap. Remove the trap and empty its contents into a wide-mouthed, airtight container that is marked CONTACT AMALGAM. Make sure that the container lid is tightly sealed. Chair-side traps that are only used for procedures not involving amalgam can be thrown in the regular garbage. Different states have different requirements for the disposal of infectious waste that is in the traps with the amalgam such as blood or saliva. Check with your local recycler or contact the Area Office of Environmental Health for the proper procedures. Reusable Chair-side Traps Open the chair-side unit to expose the trap. Remove the trap and empty its contents into a wide-mouthed, airtight container that is marked CONTACT AMALGAM. Make sure that the container lid is tightly sealed. DO NOT rinse the trap under running water. Replace the trap into the chair-side compartment. Different states have different requirements for the disposal of infectious waste that is in the traps with the amalgam such as blood or saliva. Check with your local recycler or contact the Area Office of Environmental Health for the proper procedures. Vacuum Pump Filters Change the filter to the manufacturers suggested schedule. Remove the filter. Hold the filter over a tray or another container that can catch any spills. Next pour out as much liquid as possible without losing any noticeable amalgam. The amalgam-free liquid can then be rinsed down the drain. Place the lid on the filter and put it in the box in which it was originally shipped. Once the box is full, the filters can be recycled. Line Cleaners Use only non-bleach, non-chlorine containing solutions when flushing the wastewater lines and vacuum systems. A list of ADA approved cleaners is posted at the end of this document. 140 American Dental Association (ADA) Do’s and Don’ts for Dealing with Amalgam Waste DO Do use precapsulated alloys and stock a variety of capsule sizes. Do recycle used disposable amalgam capsules. Do salvage, store, and recycle noncontact amalgam (scrap amalgam). Do salvage contact amalgam pieces from restorations after removal and recycle the amalgam waste. Do use side-chair traps to retain amalgam and recycle the contents. Do recycle contents retained by the vacuum pump filter or other amalgam collection devices, if they contain amalgam. Do recycle teeth that contain amalgam restorations. (Note: Ask your recycler whether or not extracted teeth with amalgam restorations require disinfection) Do manage amalgam waste through recycling as much as possible. Do use line cleaners that minimize the dissolution of amalgam. DON’T Don’t use bulk mercury. Don’t put used disposable amalgam capsules in biohazard containers, infectious waste containers (red bags) or regular garbage. Don’t put non-contact amalgam waste in biohazard containers, infectious waste containers (red bags), or regular garbage. Don’t put contact amalgam waste in biohazard containers, infectious waste containers (red bags), or regular garbage. Don’t rinse chair-side traps containing amalgam over drains or sinks. Don’t rinse vacuum pump filters containing amalgam or other amalgam collection devices over drains or sinks. Don’t dispose of extracted teeth that contain amalgam restorations in biohazard containers, infectious waste containers (red bags), sharps containers, or regular garbage. Don’t flush amalgam waste down the drain or toilet. Don’t use bleach or chlorine-containing cleaners to flush waste water lines. 141 Recycling As mentioned earlier the recommended method for amalgam disposal is by recycling the waste through an Environmental Protection Agency (EPA) approved vendor. The following actions should be taken to properly recycle your amalgam waste. Carry the amalgam capsules in a variety of different sizes to reduce the amount of waste produced. Personal protective equipment such as gloves, masks, and protective eyewear should be worn when handling amalgam waste. Some vendors have special requirements for the handling, storing, and transportation of amalgam waste, so be aware of any special conditions. Dental clinics that need to find a recycler should contact their county or local waste authority to inquire about an amalgam waste recycling program. Amalgam waste should be stored in covered plastic containers that are clearly labeled. Always store different types of amalgam waste (e.g., contact and noncontact) in separate containers. Do not store amalgam waste under liquid. This would require the liquid to be treated as hazardous waste. Storage in tight-fitting covered containers and routine recycling should minimize any occupational exposures. ADA Approved Line Cleaners The following line cleaners do not contain bleach or chlorine: Biocide (Biotrol International), BirexSe (Biotrol International), DRNA Vac (Dental Recycling North American Inc.), E-Vac (L&R Manufacturing Co.), Fresh-Vac (Huntington), GC Spray-Cide (GC America Inc.), Green and Clean (Metasys), Microstat 2 (Septodont USA), Patterson Brand Concentrated Ultrasonic Cleaner/Disinfectant Solution (Patterson Dental Supply, Inc.), ProE-Vac (Cottrell Ltd.), Pure-Vac (Sultan Chemists Inc.), Sani-Treet Plus (Enzyme Industries Inc.), SRG Evacuation (Icon Labs), Stay Clean (Apollo Dental Products), Turbo-Vac (Pinnacle Products), Vacusol Ultra (Biotrol International), Cavicide (Metrex Research Corp.), Vacuum Clean (Palmero Health Care). Use of a chlorine free cleaner will reduce the dissolution of amalgam. Check with your manufacturer to determine which line cleaner would be appropriate for use with your equipment. 142 C.6 SAFETY PURPOSE To establish procedures that ensure the safety of both patients and dental staff, and comply with facility safety regulations. PROCEDURE All dental personnel will have eye protection such as safety glasses, safety side shields for prescription glasses, full face shields, goggles or other eye protection approved by [Facility]. Eye protection will be worn when the individual is using the high or slow speed handpiece or is assisting when these headpieces are being used. The [program director] will delegate the authority of requiring protective wear for dental personnel to the provider in charge of their assigned area of dental care delivery. Appropriate eye protection will be provided to the employee and patients at no cost to the employee. Trays will be fabricated in the lab away from any open flames. The lathes in the dental lab will have protective shields on them. Filtered glasses will be furnished to the employee for working with the light source for light cured restorative materials. There will be no smoking in the dental clinic or in the dental offices. No open toed shoes will be worn in the patient care or dental laboratory areas (See Dress Code, Section A.12) The Facility Safety Policy and Procedure will be adhered to on all occasions and a copy of this document is found in [location]. All dental personnel will be familiar with Facility Fire, Safety and Disaster Plan. All dental personnel will know the emergency codes and how to report them to the correct location for emergency response. All dental personnel will adhere to protocol within the Infection Control Policies and Procedures manual. All job injury related incidents would be reported according to protocol set forth by [facility]. (see document [appropriate document]) All OSHA safety regulations will be strictly followed. Posted notification of guidelines will appear in the sterilization area and a copy of the regulations kept [location]. Eye wash stations are located [state location] for quick access as needed. Other Individuals in Treatment Areas The dental provider will determine if an individual not receiving dental treatment may be present in the dental operatory during treatment. Family, siblings, or other individuals who pose a safety threat to themselves or others, or who potentially interfere with safe and effective dental 143 treatment may be asked to wait outside the treatment area. Insert any instructions or handouts to parents/guardians. 144 C.7. PRECIOUS METAL RECOVERY PURPOSE To establish procedures that ensure the safe recovery and recycling of all precious metals used in dental clinic operations, minimize metal exposure to both patients and dental staff, and comply with State regulations. PROCEDURE The [appropriate individual] will be responsible for all scrap precious metal collected in the dental clinic to specific officials for their disposal. Amalgam See Mercury Hygiene Policy Silver (Omit this section if x-rays are not processed in the dental clinic) A silver recovery system will be installed on all X-ray film processors. The discharge from this system will be maintained by [appropriate individual] [frequency] according to manufacturer’s instructions. Recycling of recovered materials will be done according to manufacturer’s instructions and facility policies. To confirm that silver recovery is effective [appropriate individual] will test the effluent being discharged. Test papers and procedures will be obtained from silver recovery system manufacturer. All out of date and non-diagnostic radiographs will be collected and given to the [appropriate individual] for recycling. Gold All gold removed from a patient will be given to the patient. If the patient does not want the gold it will be placed with the amalgam scrap. [Check with your amalgam recycler to confirm gold may be accepted with scrap amalgam] 145 C.8 HAZARDOUS COMMUNICATIONS Review this policy to ensure conformity with general facility Hazardous Communications policies and forms. Forms or procedures covered in the General Facility Policies and Procedures may be omitted from the Dental Specific Policy and Procedure Manual. PURPOSE The purpose of this Written Hazard Communication program is to ensure that: 1. Hazardous substances present in the work place are properly identified and labeled. 2. Employees have access to information on the hazards of these substances. 3. Employees are provided with information on how to prevent injuries or illnesses due to exposure to these substances. 4. Identify by job title who has the responsibility for maintaining the program, the MSDS sheets, conduct training, etc. Note: This program will be available to all employees for review and a copy will be located in the following area(s): Location: 1. 2. 3. PROCEDURE The dental clinic will follow all Hazardous Communications policies and procedures in place at [facility]. [Insert dental specific HazCom procedures] (If the facility does not have a comprehensive Haz Com policy, or if the dental clinic chooses to have a separate policy, use the OHSA recommended procedures below.) AUTHORITY AND REFERENCE Occupational Safety and Health Administration (OSHA) 29 CFR 1910.1200 Dept. of Commerce (Chapter 32) (COMM) 32.15 HAZARD DETERMINATION A. A "hazardous substance" is a physical or health hazard that is listed as such in either: 1. 29 CFR Part 1910, Subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration. 2. Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment (latest edition), American Conference of Governmental Industrial Hygienists (ACGIH). B. A "hazardous substance" is regarded as a carcinogen or potential carcinogen if it is identified as such by: 1. National Toxicology Program (NTP), Annual Report on Carcinogens (latest edition). 2. International Agency for Research on Cancer (IARC) Monographs (latest edition). 3. 29 CFR Part 1910, Subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration. C. D. Manufacturers, importers and distributors will be relied upon to perform the appropriate hazard determination for the substances they produce or sell. The following materials are not covered by the Hazard Communication Standard: 1. Any hazardous waste as defined by the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, as amended (42 USC 6901 et seq.) when subject to regulations issued under that act by the Environmental Protection Agency. 2. Tobacco or tobacco products. 3. Wood or wood products. NOTE: Wood dust is not exempt since the hazards of wood dust are not "self-evident" as are the hazards of wood or wood products. 4. Consumer products (including pens, pencils, adhesive tape) used in the work place under typical consumer usage. 5. Articles (i.e. plastic chairs). 6. Foods, drugs, or cosmetics intended for personal consumption by employees while in the work place. 7. Foods, drugs, cosmetics, or alcoholic beverages in retail stores packaged for retail sale. 8. Any drug in solid form used for direct administration to the patient (i.e. tablets or pills). APPLICATION This program applies to the use of any hazardous substance which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency. RESPONSIBILITY FOR COMPLIANCE A. The administration of this program will be the responsibility of (person/position designated). The administrative responsibilities of this individual/position will include: 1. Identification of the employees to be included in the Hazard Communication Program. 2. Development and maintenance of a hazardous substance master inventory. 3. Coordination and supervision of employee training. 4. Coordination and supervision of the facility's container labeling program. 5. Coordination of any necessary exposure monitoring. 6. Coordination and supervision of required recordkeeping. 7. Periodic evaluation of the overall program. B. Employees are responsible for following all safe work practices and using proper precautions required by the guidelines in this program. HAZARDOUS SUBSTANCE INVENTORY A. (person/position designated) is responsible for compiling, maintaining, and updating, when necessary, a master list of hazardous substances used or produced in the facility. The inventory list will include the common identity or trade name of the product and the name and address of the manufacturer. Hazardous substances will be listed alphabetically by manufacturer. Substances which are not in containers will also be included on the inventory list, e.g., welding fumes, carbon monoxide from a fork lift, etc. (See Form #1) LABELING A. (person/position designated) is responsible for evaluating labels on incoming containers. Each label must contain the following information: 1. Identity of the substance. 2. Appropriate hazard warning. 3. Name and address of the manufacturer. B. If the label is not appropriate, (person/position designated) will notify the manufacturer (or supplier) that the label is not adequate. (See Form #2) (person/position designated) will send a second request to the manufacturer if the correct label is not received within 30 days. (See Form #3) (person/position designated) is responsible for preparing an appropriate label if one is not supplied by the manufacturer within the second 30 days. A container will not be released for use until an appropriate label is affixed to the container. C. Labels will be removed if they are incorrect. When the container is empty it may be used for other materials provided it is properly cleaned and relabled. D. Each department supervisor is responsible for ensuring that all containers used in his/her department are labeled properly and remain legible. Defacing labels or using them improperly is prohibited. E. Unlabled portable containers, such as pails and buckets, should be used by one employee and emptied at the end of each shift. If the secondary containers are used by more than one employee and/or its contents are not emptied at the end of the shift, the department supervisor is responsible for labeling the container with either a copy of the original label or with a generic label which has a space available for appropriate hazard warnings. *F. Piping systems shall be painted at access points and every 10 feet where the piping is 8 feet or closer to employee contact. 1. Piping shall be painted as follows: a. b. (substance)(color) (e.g., oxygen) (e.g., green) MATERIAL SAFETY DATA SHEETS A. MSDS's will be available to the employees on all hazardous substances to which there is potential or actual exposure. (person/position designated) is responsible for ensuring that MSDS are available on all incoming products. A product will not be released for use until a completed MSDS is on file. (See Form #4) If the MSDS is not available, (person/position designated) will notify the manufacturer that MSDS is needed. (See Form #5). (person/position designated) will send a second request to the manufacturer if the MSDS is not received within 30 days. (See Form #6) B. (person/position designated) is responsible for the review of all incoming MSDS's. If the MSDS is not complete, it will be returned to the manufacturer with a request for the missing information. (See Form #7) (person/position designated) will send a second request for the missing information if a complete MSDS is not received within 30 days. (See Form #8) *C. D. (person/position designated) will request an MSDS on the purchase orders of all new products. (See Form #9) (person/position designated) is responsible for compiling and updating the master MSDS file. This file will be kept at (Name of location). Copies of MSDS's will be kept in the following areas: Department Location [state department] [state location] E. Employees will have access to these MSDS's during all work shifts. Copies will be made available upon request to (person/position designated). (See Form #10) F. (person/position designated) is responsible for updating the data sheets to include new information as it is received. A notice will be posted to inform employees that revised information has been received. (See Form #11) EMPLOYEE TRAINING A. Prior to starting work with hazardous substances, each employee will attend a Hazard Communication Training Session where they will receive information on the following topics: 1. Policies and procedures related to the Hazard Communication Standard. 2. Location of the written Hazard Communication Program. 3. How to read and interpret an MSDS. 4. Location of MSDS's. 5. Physical and health hazards of hazardous substances in their work area. 6. Methods and observation techniques to determine the presence or release of hazardous chemicals. 7. Work practices that may result in exposure. 8. How to prevent or reduce exposure to hazardous substances. 9. Personal protective equipment. 10. Procedures to follow if exposure occurs. 11. Emergency response procedures for hazardous chemical spills. B. Upon completion of the training program, each employee will sign a form documenting that he/she has received the training. (See Form 12) C. Whenever a new employee is transferred or hired, he/she will be provided training regarding the Hazard Communication Standard. The training session will be conducted by _________________ before the start of his/her employment if possible. D. (person/position designated) is responsible for identifying and listing any non-routine hazardous task performed at this facility. (person/position designated) will conduct training on the specific hazards of the job and the appropriate personal protective equipment and safety precautions and procedures. (See Form 13) E. When a new substance is added to the inventory list, (person/position designated) is responsible for reviewing the MSDS for potential health effects. If the product presents a new health hazard (causes health effects unlike those covered in the training session), the ((person/position designated)) is responsible for notifying all affected employees about the new health effects which result from exposure to the new substance. *A copy of the new Material Safety Data Sheet (MSDS) will be posted by (person/position designated) for 30 days. Both the new Material Safety Data Sheet and the Employees New Substance Signature Form will be placed above or near the MSDS information binder. Each affected employee must read the MSDS and sign the signature form. (See Form #11) INFORMATION TO CONTRACTORS A. (person/position designated) is responsible for providing outside contractors with the following information: 1. Hazardous chemicals to which they may be exposed as a result of working in this facility. 2. Suggestions for appropriate protective measures. B. Contractors that are potentially exposed to hazardous chemicals present at the facility will not be allowed to begin work until they have been provided information concerning these hazards and have signed a form to document this exchange. (See Form #14) C. (person/position designated) is responsible for obtaining information from contractors on all hazardous substances to which State employees may be exposed as a result of the contractor's work at the facility. (See Form #15). (person/position designated) will notify affected employees about the health affects that may result from exposure to each substance. PERSONNEL POLICIES When an employee is not following safety and health rules regarding working with a hazardous substance, disciplinary action will be taken. RECORD KEEPING A. All MSDS's will be kept for a period of ____ years after the use of the substance has been discontinued. EXCEPTION: If an employee exposure to a particular hazardous chemical occurs, the MSDS for that product will become part of the employee's medical records. Medical records must be kept for 30 years. Note: “Exposure” or “exposed” means that an employee is subjected to a toxic substance or harmful physical agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorbtion, etc.), and includes past exposure, but does not include situations where the employer can demonstrate that the toxic substance or harmful physical agent is not used, handled, stored, generated, or present in the workplace in any manner different from typical non-occupational situations. *B. The master inventory list will also be kept for ____ years. COMMUNITY HAZARD COMMUNICATION (person/position designated) is responsible for responding to requests from members of the community on hazardous substances used in the facility. EMERGENCY RESPONSE PROCEDURES FOR HAZARDOUS CHEMICAL SPILLS A. When a hazardous chemical spill occurs, follow these procedures: 1. Move all employees away from spill to a safe environment. 2. Call 911 or the designated emergency response number in your area to notify the necessary response team for the hazardous chemical spill. 3. Retrieve the Hazard Communication Information Binder, if possible. a. Locate the MSDS for the hazardous chemical which spilled. b. If requested, provide the MSDS to the Emergency Response Team. Note: Do not try to contain the spill. The Emergency or Hazardous Material Response Team is trained to deal with hazardous chemical spills. PROGRAM EVALUATION [person/position designated] will conduct an evaluation of the Hazard Communication program annually. The individual responsible for the items identified for improvement will be notified in writing. It is expected that action will be taken to correct the item within five working days. (See Form #16) * At least annually, ___(indicate number) employees will be interviewed to determine the effectiveness of the Hazard Communication Program. Each interview will access the employee's retention of information given during the training session, use of MSDS's and response to chemical spills (if applicable). The results of each interview will be recorded on the Employee Interview Form. (See Form #17) The Employee Interview Form will be retained on file for 12 months. This written program has been developed by the Bureau of State Risk Management, Department of Administration and is available on computer disk. (File name a:\hazcom.doc). It may be adapted to fit the particular needs of your facility. The program was adapted from a written program originally developed by the Occupational Safety and Health Administration (OSHA). Note: When there is an asterisk (*) placed in front of a guideline, then this policy is not required by the Hazard Communication Standard or the Employees Right-To-Know Law. Form #1 HAZARDOUS SUBSTANCE INVENTORY Organization :_______________________________________________ Location: ____________________________________ Manufacturer Product Name Quantity MSDS Yes/No Work Area Completed By: _________________________________________________________Date: _____________________________ Form #2 TO: LETTER TO REQUEST A COMPLETE LABEL Chemical Manufacturer, Vendor, Distributor FROM: (Agency Name, Address) DATE: RE: Chemical Labels We are using (number) of your products and in evaluating the label(s) on (this/these) product(s), we determined that the label(s) (is/are) not appropriate for the following reason(s): Product Name Reason Label Is Not Appropriate Please clarify the wording on (this/these) label(s) or send (a) revised label(s). Your prompt attention is necessary for us to fully implement our Hazard Communication Program. Please respond to this request no later than (date 14 days after the date of this letter). Thank you for your cooperation. * A tickler file should be established to notify the responsible individual in 14 days that their request for a revised label has not been received and that a second notice is needed. 154 Form #3 TO: SECOND REQUEST FOR A COMPLETE LABEL Chemical Manufacturer, Vendor, Distributor FROM: (Agency Name, Address) DATE: RE: Labels On (date) we notified you that the warning label for your product(s) was incomplete. The label is not appropriate for the following reason(s): Product Name Reason Label Is Not Appropriate We requested that you supply us with this information by (date). Please clarify the wording on (this/these) label(s) or send (a) revised label(s). Your prompt attention is necessary for us to fully implement our Hazard Communication Program. Please respond to this request no later than (date 14 days after the date of this letter). Thank you for your cooperation. 155 CHECKLIST OF REQUIRED MSDS INFORMATION Form #4 The Hazard Communication Standard 1910.1200 requires that 13 items of information be included in Material Safety Data Sheets provided to purchasers. There is no specified order for these items; they may be found anywhere on the MSDS. If the preparer of the MSDS has found no relevant information for a given item, the MSDS must be marked to indicate that no applicable information was found. This checklist should be used to determine the completeness of the MSDS. It does not assess the accuracy of the information. Check Box If Item Is Complete 1. The identity used on the label. 2. Chemical and common names - may be the same as #1. 3. Physical and chemical characteristics of the hazardous ingredients (e.g., flash point, appearance and odor). 4. 5. Physical hazards (e.g., combustible, unstable). Health hazards (e.g., corrosive) plus signs and symptoms of exposure and medical conditions aggravated by exposure. 6. Primary route(s) of entry (e.g., inhalation). 7. Air exposure limits (e.g., PEL, TLV). 8. Carcinogenicity. 9. Precautions for safe handling and use (e.g., storage, waste disposal). 10. Control measures (e.g., personal protection). 11. Emergency and first aid procedures. 12. Date of preparation of MSDS. 13. Name/address/phone number of responsible party. PRODUCT: MANUFACTURER: DATE OF MSDS: CHECKED BY: 156 Form #5 TO: LETTER TO REQUEST MSDS Chemical Manufacturer, Vendor, Distributor FROM: (Agency Name, Address) DATE: RE: Material Safety Data Sheets (MSDS) We are using (number) of your products and need (a) Material Safety Data Sheet(s) in order to complete our Hazard Communication Program. Please send (a) Material Safety Data Sheet(s) on the following products: Your prompt attention is necessary for us to fully implement our Hazard Communication Program. Please send the MSDS(s) no later than (date 15 days after the date of this letter). Thank you for your cooperation. * A tickler file should be established to notify the responsible individual in 15 days that their request for an MSDS has not been received and that a second notice is needed. 157 Form #6 TO: SECOND REQUEST FOR MSDS Chemical Manufacturer, Vendor, Distributor FROM: (Agency Name, Address) DATE: RE: Material Safety Data Sheets (MSDS) On (date) we requested (an) Material Safety Data Sheet(s) on the following product(s): We have not received (it/them). Your prompt attention to this is necessary for us to complete our Hazard Communication Program. Please respond to this second request by (date 15 days after the date of this letter). Thank you for your cooperation. 158 Form #7 TO: LETTER TO REQUEST A COMPLETE MSDS Chemical Manufacturer, Vendor, Distributor FROM: (Agency Name, Address) DATE: RE: Material Safety Data Sheets (MSDS) In reviewing the Material Safety Data Sheet(s) for your product(s), the following required information (according to the OSHA Hazard Communication Standard 1910.1200) was not on the MSDS: Product Name Reason MSDS Is Not Complete Please supply us with this information. Your prompt attention to this is necessary for us to fully implement our Hazard Communication Program. Please send this information by (date 15 days after the date of this letter). Thank you for your cooperation. * A tickler file should be established to notify the responsible individual in 15 days that their request for a revised MSDS has not been received and that a second notice is needed. 159 Form #8 TO: SECOND REQUEST FOR A COMPLETE MSDS Chemical Manufacturer, Vendor, Distributor FROM: (Agency Name, Address) DATE: RE: Material Safety Data Sheets (MSDS) On (date) we notified you that the Material Safety Data Sheet(s) for your product(s) (was/were) incomplete. The following required information was not on the MSDS(s): Product Name Reason MSDS Is Not Complete We requested that you supply us with this information by (date) . We have not received this information. Your prompt attention to this is necessary for us to complete our Hazard Communication Program. Please respond to this second request by (date 15 days after the date of this letter). Thank you for your cooperation. 160 Form #9 LETTER TO ACCOMPANY PURCHASE ORDERS This is a notice to chemical vendors concerning the need for MSDS’s and container labeling. This letter should be attached to purchase orders for all chemicals or other hazardous substances. TO: Chemical Manufacturer, Vendor, Distributor FROM: Organization Name and Address DATE: RE: Hazard Communication Responsibilities Attached to this letter is a purchase order for the chemicals which we plan to utilize in our facility. Our receiving personnel have been instructed to accept only containers which have been properly labeled and identified. Improperly labeled containers will result in refusal of the shipment. We would appreciate your cooperation in this matter. We expect to receive Material Safety Data Sheets (MSDS) prior to receipt of our initial order and/or when an MSDS has been revised. If your policy is different, or has changed since our last order, please notify us as soon as possible. To assist us, we would appreciate if you would record the responsible party information on the shipping papers. If you have any questions, please do not hesitate to contact me. Thank you for your cooperation. I look forward to working with you in the future. Yours truly, (Name of Purchasing Director/Program Director) NOTE: THIS LETTER SHOULD BE ATTACHED TO THE INITIAL AND/OR TO EACH PURCHASE ORDER FOR CHEMICALS OR HAZARDOUS SUBSTANCES 161 Form #10 REQUEST FOR CHEMICAL HAZARD INFORMATION (Use a separate form for eachchemical/material) Name of Requester (S): Date: Social Security Number: Department: Name of Chemical/Material: Manufacturer: Description: (Please describe the material as completely as possible) Date Employee or Union Representative Signature Received copy of MSDS: Yes Copy provided by: No Date: 162 Form #11 EMPLOYEE'S NEW CHEMICAL/SUBSTANCE SIGNATURE FORM Name of New Chemical/Substance: Vendor's Name: Location: Date the Chemical Arrived: Date of Posting (MSDS) Form: This chemical may have health effects not covered during your initial Hazard Communication Training Session. Each affected employee is asked to read the attached Material Safety Data Sheet (MSDS) to understand the new health effects for the following chemical: Upon reading the Material Safety Data Sheet (MSDS), each employee must sign and date this form. 1. 6. 2. 7. 3. 8. 4. 9. 5. 10. 163 Form #12 EMPLOYEE HAZARD COMMUNICATION TRAINING RECORD The following employee(s) have completed training in Hazard Communication. Each trained employee is now knowledgeable in all 11 different training topics covered in the Hazard Communication Written Training Program. Policies and procedures related to the Hazard Communication Standard. Location of the written Hazard Communication Program. Physical and health hazards of hazardous substances in their work area. How to prevent or reduce exposure to hazardous substances. Personal protective equipment. Methods/observation/techniques to determine the presence or release of hazardous chemicals. How to read and interpret MSDS. Location of MSDS. Work practices that result in exposure. Procedures to follow if exposure occurs. Emergency response procedures for hazardous chemical spills. Employee's Name Employee's Signature Date of Training 164 Trainer Trainer's Signature Form #13 NON-ROUTINE HAZARDOUS TASK TRAINING DOCUMENTATION FORM The following employee(s) has/have been trained to perform work in what is considered a "non-routine hazardous task." Nonroutine Hazardous Task Employee(s) Name 165 Date of Training Trainer Form #14 DOCUMENTATION OF INFORMATION GIVEN TO CONTRACTORS PERTAINING TO HAZARD COMMUNICATION Facility: _____________________________________ Location: ________________________________________ Date Contractor Information Given 166 Contractor’s Signature Form #15 LETTER TO CONTRACTORS Subject: OSHA HAZARD COMMUNICATION STANDARD To Whom it May Concern: The Occupational Safety & Health Administration (OSHA) Hazard Communication Standard (29CFR 1910.1200) states that contractors/suppliers must be informed of the hazardous chemicals their employees may be exposed to while performing their work and any appropriate protective measures. In order to comply with this requirement, (Name of facility) has developed a list of all the hazardous chemicals known to be present in our facility. A Material Safety Data Sheet (MSDS) is also on file for each of these chemicals and/or hazardous substances. This information is available to you and to your employees upon request. In order to protect the safety and health of our own employes, contractors/suppliers must provide (upon request) an MSDS on any hazardous chemical(s) or material(s) which they bring into this facility. Failure to provide this information in a timely manner will result in the removal of the contractor/supplier from the premises. Each employer is also responsible for notifying any subcontractor they employ regarding the requirements of OSHA's Hazard Communication Standard and other provisions described in this letter. If we can be of any further assistance, please feel free to contact me at (phone number). Sincerely, 167 Form #16 HAZARD COMMUNICATION ANNUAL PROGRAM SUMMARY Training Number of Training Courses Presented: Number of Employees Trained: # of Different Hazardous Substances in Use: # of MSDS on File: New-employee training: Work-area-specific training: New-substance training: Other training: Total courses/employees Hazardous Substances Previous Total: New This Year: Revised Total: The following activities have been completed: Written plan is up to date. Hazardous substance inventory has been updated. All training is up to date. All MSDS are up to date. All products are properly labeled. All portable containers are properly labeled. If any of the above activities are not complete, explain: Completed By: __________________________________________ Date: ________________________ 168 Form #17 EMPLOYEE HAZARD COMMUNICATION INTERVIEW Date of Interview: Interview conducted by: Agency: Location: ________________________________________________________________________ 1. Do you feel that your organization's Hazard Communication Program is successful overall? Yes ____ No ____ Why? ______________________________________________________________________________ ______________________________________________________________________________ 2.What was the subject of the last training session you attended? _______________________________________________________________________ __________________________________________________________________________ 3.Have you applied the information from that session? Yes ____ No ______ If yes, how? _____________________________________________________________________ ________________________________________________________________________ 4. Have you had an occasion to refer to an MSDS in the last month? Yes ____ No _____ Which one? a. Was the MSDS easy to understand? Yes ____ No ____ b. Why did you refer to the MSDS? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ c. Did the MSDS have the information you were looking for? Yes ___ No ______ If no, what information was missing? ____________________________ ___________________________________________________________________ 5. Have all of the containers in your work area been properly labeled and marked? Yes ____ No ____ 169 6. Over the last six months, has your work area been involved in any chemical spill or emergency? Yes ____ No ____ If yes, describe 7. Were you prepared? Yes ____ No ____ If not, why not?____________________________ ________________________________________________________________________ ________________________________________________________________________ 170 Form # 18 HAZARD COMMUNICATION CHECKLIST Has a program for hazard communication training been established? Has a program for hazard communication procedures been established and is the program reviewed on an annual basis? Are chemical injuries tracked for program improvement? Have chemical hazard control procedures developed for each job? Has a chemical inventory of the facility been conducted? Are the procedures reviewed on an annual basis? Do the hazard communication procedures include the following: A statement of the intended use? Steps for labeling of containers? Steps for safe issuance, use, transfer and disposal of chemicals? Are control procedures inspected at least annually? Are periodic inspections conducted by a competent employee? Is the inspection designed to correct deviations or inadequacies? Is the inspection documented? Have MSDSs been produced in accordance with 29CFR 1910.1200? Have employees been informed of: The requirements of 29 CFR 1910.1200? Any operations in their work area where hazardous chemicals are present? The location and availability of the written HAZCOM program? The location and availability of the lists of hazardous chemicals? Does employee training include at least: Methods & means necessary to detect the presence or release of a chemical? The physical and health hazards of the chemicals in the work area? The steps employees can take to protect themselves from the chemicals? The details of the written program? Have criteria for recurrent training been developed? Is the training documented? Is the training conducted by a competent person? Is retraining required whenever there is a change in job assignments? 171 Yes No Section D: QUALITY ASSURANCE 172 D.1 CONTINUOUS QUALITY IMPROVEMENT (CQI): CLINICAL QUALITY PURPOSE The purpose of this CQI plan is to continuously improve the quality of care provided to patients by members of the Dental Department. This will be accomplished thought the efforts of the Dental Staff both inter- and intra- departmentally within [facility]. PROCEDURE Describe CQI plan including all activities, indicators, data collection, frequency of activities and reporting. For assistance with developing a CQI plan in an Indian Health Service/Tribal/Urban facility, contact your Dental Support Center or Area Dental Officer. Responsibility The individual responsible for the quality assurance and improvement activities of the Dental Department is [appropriate individual]. The [individual] may delegate this responsibility to other members of the dental staff. It shall also be the responsibility of the dental QA/QI Coordinator to coordinate interdepartmental activities with the CQI programs of those departments so as to provide for quality improvement throughout the facility. Indicators The dental staff as a group will develop a set of indicators of quality of care for each of the important aspects of care being monitored. Each indicator will be objective, measurable, and based on current knowledge and clinical experience. Indicators must be easily replicated in order to track improvement. Each indicator will specify a patient care activity, event, or outcome that is to be monitored and evaluated to determine if patient care conforms to current standards. Modifying Indicators Indictors will be reviewed regularly. Indicators that are consistently met may be considered to be removed and other issues examined. Sentinel Events Additionally, certain unpredictable occurrences in the dental clinic (usually small in number but with very high morbidity or mortality) are of such importance that all such occurrences must be carefully examined, even though objective criteria cannot be formulated in advance for them. Examples of such sentinel events would include: Deaths in the dental clinic Allergic reactions/anaphylactic reactions to medications. Formal complaints or lawsuits. In addition to other processes set into motion by such events, dentists review each sentinel event and a Quality Improvement Activities Summary submitted to the QA/QI Coordinator for the facility to be reviewed by the QA/QI Committee. 173 Threshold for Evaluation Each indicator in focused studies will have thresholds established based on QA documents, national averages, recommendations of appropriate experts, and other generally accepted sources. Comparison of the gathered data for each indicator with the appropriate threshold will then determine if further evaluation is indicated. Due to the high potential for morbidity or mortality, all sentinel events will be reviewed. All indicators appended to this plan will have the threshold and its source indicated. Collection and Organization of Data Routine collection of information in the Dental Department concerning important aspects of patient care will be made utilizing [identify routine reports such as Service Minutes, RVUs, equipment maintenance, others] [identify sources such as medical and dental records, monthly computer printouts, appointment logs, recall files, RPMS, environmental health reports, maintenance records, patient satisfaction surveys, etc]. The data source for each indicator is identified with the indicator, as is the frequency of collection and the responsibility for collection and analysis of the data. Evaluation of Data Once data have been collected and organized, they are evaluated to determine whether there is a problem and/or opportunity for care improvement. Evaluation of the data will determine if thresholds have been exceeded or if trends have been established. Other forms of feedback besides exceeded thresholds, such as staff or patient reports or suggestions, bench-marking with similar facilities in the Area, important single events, etc., can also be used to identify other opportunities to improve care. Corrective Actions If the evaluation identifies a problem, department staff should determine what action is necessary to solve the problem. A plan of corrective action identifies who or what is expected to change; who is responsible for implementing action; what action is appropriate in view of the problem's cause, scope, and severity; and when change is expected to occur. Emphasis will be placed on focusing actions on processes of care rather than of individuals. If a needed action exceeds the department's authority, recommendations are forwarded to the Facility QA/QI Committee. To be effective, corrective action must be appropriate for the problem's cause. Three common causes of problems are: Insufficient knowledge, skills or attitudes Defects in the system; Deficient behavior or performance. After an appropriate time has elapsed since a corrective action has been taken, reevaluation must occur to see if the corrective action was successful. This assessment of action and documentation will be used to show sustained (trend analysis) improvement in the quality of patient care. 174 Communication of Results to the Staff It is essential that monitoring and evaluation information be communicated to the necessary individuals and departments throughout the community. Such interaction of information will begin with dental department staff meetings. Minutes of these meetings will be kept, and reports will be forwarded to the [appropriate individual] and medical staff according to the bylaws and rules and regulations of the medical/dental staff. Integrating quality improvement information contributes to the detection of trends, performance patterns, or potential problems that affect more than one clinic or department of the facility. It also allows the information gathered to be used in granting and reassessing privileges and in conducting other performance evaluations such as employee performance standards. Annual Appraisal The effectiveness of the Dental Department's CQI Program will be evaluated annually by the [appropriate individual(s)]. This annual reappraisal of the CQI Program will include evaluation of the organization, including the scope, effectiveness, objectiveness, comprehensives of the current activities, and community input from tribal sources or patient satisfaction surveys. The results of this evaluation will be reported to the [appropriate individual]. Confidentiality All QI records shall be maintained in accordance with the Privacy Act, Freedom of Information Act, and other local confidentiality policies as applicable. 175 D.2 RISK MANAGEMENT/PROGRAM MONITORING [Insert facility’s Policy Header Information] PURPOSE The purpose of this Risk Management plan is to continuously improve the quality of dental program and reduce risk that may be introduced through dental care provided at [facility]. PROCEDURE Program Elements [Appropriate individual] will coordinate risk management with [administration or appropriate individual e.g. safety officer]. Incident and accident reports will be completed and processed as per Facility policy. Valid patient and employee complaints will be referred to the appropriate staff for appropriate management. A program review and infection control review will be conducted annually. Results will be submitted to [appropriate individual]. Deficiencies will be address in a staff meeting, through continuing education, or other appropriate means. See Attachment * for program review tools or forms. Tracking [CE coordinator or appropriate individual] will ensure appropriate certifications such as CPR, radiology, CE, and other mandatory certifications are maintained by dental staff. Additionally, dental staff is responsible for maintaining facility required training such as Electrical Safety, Fire Safety, Infection Control, MSDS, Blood Borne Pathogens, and Hazard Communications training as per facility safety guidelines [Frequency as required by the facility] quality assurance activity report will be submitted to the [appropriate individual]. 176 Nashville Area Dental Program Review Tool Nashville Area Dental Officer & USET Dental Support Center Tribe/Date: Reviewer: Executive Summary No recommendations for improvement Some minor improvements recommended Major improvements recommended Elements and ranked according to importance using industry and IHS standards. 1. Credentialing & Privileging 2. Patient Safety (Combined score for a-d below) a. Hazard Communications b. Infection Control c. Emergency Preparedness d. Other Considerations 3. Documentation 4. 5. 6. 7. 8. Policies and Procedures Quality Assurance & Improvement Productivity & Efficiency HP/DP Employee Development Top 3 program strengths 1. 2. 3. Top 3 program recommendations 1. 2. 3. 177 Score Summary Narrative I. II. III. IV. V. VI. VII. VIII. Credentialing and Privileging Patient Safety: Documentation Policies and Procedures Quality Improvement and Assurance HPDP Clinical Productivity Employee Development 178 Recommendations Checklist Category Recommendation Credentialing & Privileging Patient Safety Documentation Policies and Procedures Quality Improvement and Assurance HPDP 179 Completion Date Category Recommendation Productivity & Efficiency Employee Development 180 Completion Date Y e s Scoring Element a) All dentists in the facility have an active, unrestricted license to practice in their profession, with proof of licensure on record at the clinic. b) All dentists in the facility have been credentialed in accordance with the clinic’s credentialing policies. c) Credentialing files contain a NPDB query, a criminal background check, and verification of a DEA license, dental license, and dental degree(s). d) Continuing education is updated in the credentialing file, or according to clinic policies. e) All dentists in the facility have been granted privileges for the clinical procedures they perform by the facility’s governing body/health board; hygienists are either privileged or written scope of work. Providers that administer local anesthesia or nitrous oxide are privileged to do so. f) Re-credentialing and re-privileging procedures are completed on all dentists at least every two years. g) All dental assistants have been properly trained, certified, and current in the taking of radiographs and other services that they provide. h) Peer reviews are used to evaluate providers prior to recredentialing. Hazard Communications a) b) c) d) e) f) g) The program has a hazard communication program in the facility. Staff understands and can use the MSDS book. The program has an updated MSDS book, and a random sample of chemicals in the clinic shows no deficiencies. Staff receives annual Hazard Communication training per OSHA regulations. The program adheres to local environmental guidelines on the disposal of mercury. Staff can demonstrate what to do in a hazard spill. The program has practiced or discussed a hazard spill at least once in the past year. The program maintains incident reports on reportable events. Score 181 N o Notes Y e s Scoring Element Infection Control a) Facility has a written, updated Infection Control Policy b) Each employee has received training on infection control c) Facility has a written policy of required vaccinations d) Facility has a post-exposure management plan e) Facility has a policy regarding work related illnesses and work restrictions f) Facility has a policy for maintaining the confidentiality of employee medical records g) Each employee has received, is in process of receiving or has documentation of declination of Hepatitis B vaccination h) Standard precautions are used for all patients i) Used sharps are placed in a puncture resistant container j) Needles are recapped using either a one-handed scoop technique or a mechanical device designed for holding the needle cap k) Hands are washed with soap and water or cleaned with an alcohol gel before and after each patient l) Sterile gloves are used for appropriate procedures m) Fingernails and/or jewelry do not impair the proper use of gloves n) A surgical mask and eye protection with solid side shields or a face shield to protect mucous membranes of the eyes, nose, and mouth are worn during procedures likely to generate splashing or spattering of blood or other body fluids o) Masks are changed between patients or if the mask becomes wet p) Protective wear (gown, lab coat, uniform) is worn when skin or personal clothing is likely to become soiled q) Protective clothing is removed before leaving work area r) Gloves are worn when a potential exists for contacting blood, saliva, or mucous membrane s) Gloves are changed if they become torn and between each patient t) Patients are given protective eyewear when spatter is expected. u) Patients are screened for latex sensitivity v) The facility can provide a latex-free environment for patients with latex sensitivity w) The facility has an emergency kit with latex free items x) Critical and semi-critical items are heat sterilized before each use 182 N o Notes Y e s Scoring Element Infection Control y) Sterilized items are allowed to dry before handling z) Disposable items are not reused aa) Noncritical patient-care items are barrier-protected or cleaned, or if visibly soiled, cleaned and disinfected after each use with an EPA-registered hospital disinfectant. bb) Instrument processing area is divided into a “Clean” and “Dirty” area or measures are taken to avoid contamination of clean instruments cc) Instruments are debrided prior to sterilization dd) Puncture resistant gloves are used for instrument processing ee) Internal and external chemical indicators are used for each instrument package or load of unwrapped instruments ff) Container or wrapping system is compatible with method of sterilization gg) Unwrapped instruments are cleaned and dried prior to sterilization hh) Chemical and biological monitors are used ii) In the case of a positive spore test: problem is corrected, and another spore test is run to confirm sterilization effectiveness. All affected instruments are re-sterilized jj) Wrapped instruments are marked for date of sterilization, sterilizer, and load kk) Sterile packages are inspected before use, compromised packages are re-sterilized prior to use ll) Sterile packages are stored in a closed or covered cabinet mm) Cleaning and EPA-registered hospital disinfecting products are used correctly nn) Liquid chemical sterilants/high-level disinfectants for disinfection of environmental surfaces are not used for environmental surfaces oo) PPE, as appropriate, is used when cleaning and disinfecting environmental surfaces. pp) Surface barriers are used on surfaces difficult to clean and changed between patients qq) Contaminated environmental surfaces are appropriately cleaned rr) Spills of blood or other potentially infectious materials are cleaned and decontaminated with an EPAregistered hospital disinfectant with low- (i.e., HBV and HIV label claims) to intermediate-level (i.e., tuberculocidal claim) activity ss) Facility has an infected waste management plan 183 N o Notes Y e s Scoring Element Infection Control tt) Contaminated non-sharp waste is stored in a puncture resistant, color coded bag uu) Liquid waste is disposed of in a sanitary sewer system or in a manner in accordance with state regulations vv) Water used for routine dental treatment meets EPA standards for drinking water ww) Any device connected to a water system that enters the patient’s mouth is flushed for 20-30 seconds between patients xx) Water lines are monitored according to manufacturer’s instructions yy) Handpieces are removed, cleaned and sterilized between each patient zz) Patients are not instructed to close lips around suction devices aaa) Gloves are worn when exposing radiographs and when handling contaminated packets bbb) Radiography film holders are disposed of, heat sterilized or disinfected appropriately between patients ccc) Aseptic procedures are used when transporting and developing films ddd) Dispensing medication from multi-dose vials: a) sterile needles and syringe are used for each patient and b) vials are kept out of patient care areas. eee) Biopsy specimens are stored in a sterile, leakproof container labeled with the biohazard symbol fff) Extracted teeth are handled as regulated medical waste unless returned to the patient ggg) Extracted teeth to be used for educational purposes are appropriately sterilized hhh) Appropriate PPE is used for all laboratory procedures iii) Prostheses and impressions are sterilized before handled in the laboratory jjj) Facility conducts periodic infection control monitoring kkk) Practices not in compliance with infection control standards are addressed Score 184 N o Notes Y e s Scoring Element Emergency Preparedness a) The program has a written fire/disaster emergency plan. b) The program has a written medical emergency plan for the dental clinic, and staff has participated in at least 1 medical emergency drill in the past year in dental. c) Emergency codes are accessible and prominently displayed in the clinic and reviewed with staff. d) Emergency phone numbers are prominently displayed in the clinic. e) An emergency kit is readily available, appropriate to Dental Clinic needs. f) If drugs are kept in the clinic, all dental staff knows its location and how to use the contents. g) The expiration dates of the drugs in the emergency kit are current. h) An oxygen tank with an appropriate valve, tubing, and mask is available. Dental staff is familiar with its location and use. i) The oxygen/nitrous oxide tank is checked routinely for leaks and function and this is documented. j) All dental staff is currently BLS certified, and documentation is maintained of BLS certification. k) A crash cart is available in the facility. a) b) c) d) e) f) g) h) i) j) k) Score Other Safety Considerations X-ray machines are inspected at the required 3-year intervals. Deficiencies are corrected in a timely manner Lead aprons are used on all patients receiving radiographs. The aprons are x-rayed annually to assure that no damage occurred to the lead lining during storage and/or use. Radiograph frequency adheres to ADA guidelines. Film positioners are used. Neither patient nor staff holds the film during exposure. Staff and other patients are protected from scatter radiation during film exposure. The agitator of the amalgamator functions under a protective cover. Amalgam scrap is stored in tightly closed containers Amalgam scrap is recycled properly. Medication and product recalls are documented. Expired drugs are removed from inventory in a timely manner. Score 185 N o Notes Y e s Scoring Element a) A health questionnaire completed by the patient and signed by the provider within the past 12 months is present and documentation exists that it was reviewed at each visit with the changes or the phrase “no changes” recorded. Medical alerts are highlighted. b) Appropriate measures have been taken to ensure patient safety and appropriate treatment. (eg- blood pressure, blood sugar, consultations when necessary). c) Appropriate ADA codes are recorded (including tooth number, surface, or pocket depths when appropriate) and documentation exists in the progress note to justify all codes. d) Dental Progress Notes include: a. date of treatment b. signature of the provider(s) c. if signature is illegible, printed or stamped name of provider(s) d. degree of the provider(s) e. If the patient was seen as a dental emergency, the SOAP format was used e) Dental progress notes include a disposition (what the patient needs next) at the end of each visit. f) Informed consent contains risks, benefits, and alternate treatments, and in language the patient can understand. g) The informed consent form is signed by the dental provider and patient/parent/guardian. h) Pain documentation is included on the progress note. Documentation is consistent with the facility policies. If pain is indicated, additional information on the management, treatment, or referral for tx is included. i) All hard tissue findings (normal, pathology, or abnormalities) are recorded in the dental record. j) Documentation that radiographs have been read exists in the patient record. This may be either in the progress note or on the Exam Form. k) Evidence of soft tissue exam is present, either by listing of abnormalities or designation of “STN” (Soft Tissues Normal) or “WNL” (Within Normal Limits). l) Periodontal status (CPITN or PSR) and diagnosis for patients age 15 and older is noted on the dental exam. m) Orthodontic status (for patients ages 6 to 20) is noted on the dental exam sheet. Score (% yes) 186 N o Notes Y e s Scoring Element n) Written treatment plan exists for all patients receiving initial or recall dental exams. a. Treatment plan is easily understood b. Follows a logical sequence c. Is revised as needed, revisions are dated and initialed o) If a full scope of services is not available at the facility, a chart notation is made that the patient has been informed of his/her need for treatment at another facility. p) The patient is placed in a recall program based on his/her individual risks and clinic resources, rather than arbitrary time intervals. q) Pre-operative x-rays are evident for appropriate procedures. r) Documentation of the behavior for all children under the age of 6 is documented. s) Behavior management techniques used and their level of effectiveness are documented. t) When definitive periodontal therapy is planned for patients with CPITN/PSR of 2 “4’s”, a periodontal workup is conducted. This includes probing pocket depths, furca involvement, mobility, and occlusal features, with documentation. u) The dental record contains an individualized dental disease prevention plan. Score 187 N o Notes Chart Review Facility:_______________________ Provider: _____________ Record Number CRITERIA Y-Yes Note: Threshold for N- No success is 80% NA- Not Applicable A. Every Visit (Total=__) 1) 2) 3) 4) 5) 6) Completed and Signed Medical History, Updated Precautions appropriate for PS Appropriate Codes Complete progress notes(SOAP for Emer) Disposition Informed consent contains risks, benefits, and alternate treatments, and in language the patient can understand. 7) Informed consent is signed by provider and patient/parent/guardian. 8) Pain Documentation B. Exam and Treatment plan (Total=__) 1) 2) 3) 4) 5) 6) 7) 8) 9) Hard tissue findings recorded X-rays read Soft tissue findings recorded Periodontal status and diagnosis Orthodontic status Treatment Plan Complete Notation of needed, unavailable services Follow up/ recall consistent with patient needs The dental record includes an individualized dental disease prevention plan. C. Treatment Documentation 1) 1)Pre-operative x-rays are evident for appropriate procedures. 2) 2) Documentation of behavior is evident for all children under the age of 6. 3) Behavior management techniques used ant their level of effectiveness is documented. 4) When definitive periodontal therapy is planned for patients with CPITN/PSR of 2 quadrants of “4” or more, a periodontal workup is conducted. This includes probing pocket depths, furca involvement, mobility, and occlusal features with cumentation. 188 Y e s Scoring Element N o a) The facility has a policy and procedure manual for dental department. b) The policy manual must include the following critical policies/procedures: a. Patient eligibility including determination of eligibility for services and CHS is in the P&P Manual. b. Scope of services is included in the P&P Manual. c. Standing orders for auxiliaries are included in the P&P Manual. d. The clinic has an appointment/broken appointment policy. e. The clinic has a pain management policy. f. The clinic has a behavioral management/restraint policy and procedure. g. Identifies procedures for which a separate informed consent is required. h. Identifies management of patients with medical issues such as hypertension, diabetes, etc. i. Identifies documentation guidelines (required documentation for clinical care). c) The Policy and Procedure Manual is updated annually. d) Staff has received an update on Policies and Procedures within the last year. e) The dental program operates under a written, readily available, working copy of a P&P Manual. f) The clinic has standard protocols for common services. Additional Notes 189 Score Notes Y e s Scoring Element a) The clinic has a quality assurance and improvement plan. The clinic demonstrates local facility quality benchmarking against best practices, professional practice guidelines, overall health care goals, or performance measures. b) Department regularly monitors quality of care (delivery of care) through internal activities (quality assurance). c) The program has conducted at least one patient satisfaction/customer service survey in the past year. d) Nitrous oxide/oxygen administration is monitored annually for exposed workers and for leaks. e) The dental clinic has conducted at least one quality improvement program in the past year, with documentation of evaluation (PDSA or similar). f) The dental program actively participates in the facility’s quality assurance/improvement program. Additional Notes 190 N o Notes Score Y e s Scoring Element a) b) c) d) a) b) c) d) e) f) g) h) i) j) k) l) m) n) o) 3. Clinical Productivity and Efficiency Productivity The average number of patient visits in the year preceding the review is greater than 1,926 per dentist. More than 40% of registered users at the facility have utilized dental services in the past year (this is different than the GPRA user population). The average number of total services in the year preceding the review is greater than 7,000 per dentist. The average number of relative value units (RVUs) produced by the clinic in the year preceding the review is greater than 10,146 per dentist. Efficiency & Effectiveness The clinic has a dentist to population ratio of 1:1200 or better. The dental clinic has a full time equivalent (FTE) staff to population ratio of 1:500 or better. Excluding chairs dedicated solely to dental hygienists, the dental clinic has an operatory to dentist ratio of 2:1 or better. The dental clinic has a dental assistant to dentist ratio of 2:1 or better. The dental clinic produces at least an average of 5.3 RVUs per patient visit or more. The dental clinic produces 2,697 RVUs per FTE staff or more. The dental clinic produces 3,467 RVUs per operatory or more. The dental clinic has a broken appointment rate of 23% or lower. 63% or higher of patients seen in the dental clinic have been treatment planned. 48% or higher of patients receiving exams (0145, 0150, 0120) have completed treatment. The clinic produces 10.9 RVUs per patient. The clinic produces 792 or more patient visits per operatory per year. The average dentist productivity is 8.68 or higher patient visits per dentist per day. 80% or higher of all services were Level I-III (basic) services for the past year. The clinic produces a minimum of 5 RVU’s per dentist and 3.5 RVUs per hygienist per hour. 191 N o Not es Scoring Element Y e s N o Notes Y e s N o Notes a) The dental program has overall HP/DP goals or has identified high priority areas. b) At least one HP/DP program has been conducted in the past year by dental staff utilizing the POARE (Problem, Objectives, Activities, Results, and Evaluation) or similar program planning model or similar model. c) The program regularly evaluates community-based prevention activities. d) There is evidence of sharing goals and results of HP/DP programs conducted with tribal leaders, facility administration, dental staff, and the community. e) Dental staff is aware of the clinic’s HP/DP goals and current project(s). f) The dental program is actively collaborating with nondental staff (in the facility) on an HP/DP project. g) An ongoing fluoride program is established at the community level, involving non-health care partners. This includes water fluoridation or topical fluorides (i.e., fluoride varnish) and collaborative partners may include Head Start, schools, or the water resource department. h) The program has built collaborations within the community and facility (i.e., medical, Head Start, daycare, schools, WIC, etc.). i) The dental program achieved its access to care GPRA goal in the last reporting year. j) The dental program achieved its dental sealant GPRA goal in the last reporting year. k) The dental program achieved its fluoride GPRA goal in the last reporting year. Score Scoring Element a) The dental program has performance plans/individual development plans for all dental staff. b) The dental program provides evidence of regular dental staff meetings. c) All dental staff is given opportunities for continuing education during the year. d) Staff has received HIPAA and Privacy Act training in the past year. e) All licensed or certified dental staff has met continuing education requirements in the past year. Score 192 Sample Employee Training Tracking Form Employee Name___________________ Position _______________ ANNUAL (Year) Year Year Year CPR CERT RADIOLOGY CERT SAFETY INFECTION CONTROL M.S.D.S. MED EMERGENCY BLOOD BORNE PATHOGENS (List others) Comments: 193 Year Sample Facility Review Tracking Form Frequency QA REPORT PROGRAM REVIEW INFECTION CONTROL RADIOLOGY CERTIFICATION Comments: 194 SECTION E: COMMUNITY HEALTH 195 E.1 COMMUNITY ORAL HEALTH PROMOTION/DISEASE PREVENTION PURPOSE To establish community oral health promotion/disease prevention (HP/DP) procedures consistent with current science and Indian Health Service priorities. PROCEDURE 1. Written Plan: the dental staff will develop a written community HPDP plan that will include: a. Priorities: The dental staff will establish oral HP/DP priority areas based on local needs and IHS focus areas. b. Target Groups: The dental staff will determine high risk groups that will most benefit from community based HP/DP programs. c. Evidence Based Activities: The dental staff will select evidence based activities to address oral health needs for the priority areas and target groups. d. Evaluation: The dental staff will regularly monitor the effectiveness of the programs, collect data on the program operation and outcome, and revise the program as needed to ensure maximum effectiveness. 2. Annually, the dental staff will review the plan and revise as needed. Insert Community HPDP Plan 196 Example: [Facility] Dental Prevention Plan Oral Health Condition Partners Target Group ECC/ Caries Prevention Head Start teachers and staff Children age 3-4 4-9 Days /Year Caries, Perio, and Tobacco Prevention Elem School School Age Children 2-3 Days /Year Perio Prevention Medical dept Dietician DM Patients ECC Prevention/Perio Medical Dept Pregnant women and families Frequency 197 Services *Current #Planned *Annual Screening *Fluoride Varnish *OHI *Tobacco Prevention *Nutritional *Counseling *Health Advisory Committee #Performance Standard assessment #Teacher inservices *Annual Screening *Fluoride Varnish *OHI *Nutritional Counseling *Tobacco Prevention #Newly diagnosed pt screening #Current DM patient screening & Ed Funding Evaluation/Tracking USET MiniAward # of children seen Fluoride treatments Untreated decay Treatment urgency Education provided Dental budget # of children seen Untreated Decay Treatment Urgency Education provided #Prenatal education #Screening & OHI #Caries stabilization #Prevention services Dental budget Visit in last year (DM audit) Patients with urgent dental needs # Screened# w/urgent needs E.2 HEAD START/PRESCHOOL PURPOSE To support the IHS Head Start mission and goals, which are, “The mission of the Indian Health Service (IHS) Head Start Program is to promote healthy activities that will improve health outcomes for the Early Head Start and Head Start child, family, staff and community. Our goals will help to improve children's health, decrease health disparities, and increase health provider outreach.” (IHS 2012, Available online at: http://www.ihs.gov/headstart/) The IHS Head Start Program goals are: o To support the Office of Head Start, including its health objectives and Performance Standard requirements. o To assist American Indian/Alaska Native (AI/AN) recipients in the development of health programs for children, families, staff and community. o To assist AI/AN programs in developing local and community partnerships. o To develop programs that promote healthy lifestyles. PROCEDURE The dental clinic staff will provide training and technical support to the [IHS Head Start or Tribal preschool] to facilitate the use of IHS Best Practices for Head Start centers.( Available online at: http://www.ihs.gov/headstart/index.cfm?module=hs_resources) The dental clinic staff will assist Head Start staff maintain dental performance standards required by IHS Head Start. Insert other services provided to Head Start or preschools. Examples: Provide direct access to dental examinations in the dental clinic Screen Head Start children in the classroom and apply fluoride varnish Serve on Head Start Health Advisory Board Consult on classroom issues such as infection control for toothbrushing programs, oral health education, or healthy snacks 198 E.3 INFECTION CONTROL FOR PORTABLE SETTINGS PURPOSE To comply with Centers of Disease Control and Prevention (CDC) and Organization for Sterilization and Aseptic Procedures (OSAP) recommendations for infection control for portable settings. DEFINITIONS Portable dental settings: All procedures conducted outside of the dental clinic including but not limited to: operative dentistry, sealants, fluoride treatments, dental screenings, or oral hygiene instructions that fall within the levels of exposure. Levels of Exposure: Classification of anticipated exposure to saliva, blood, or bodily fluids., PROCEDURE 1. Levels of Exposure a. All infection control practices will conform to the recommendations according to the level of exposure anticipated in the procedures. i. Level I: Anticipated contact with the patient’s mucous membranes, blood or saliva visibly contaminated with blood. ii. Level II: Anticipated with the patient’s mucous membranes but not with blood or saliva visibly contaminated with blood. iii. Level III: No anticipated contact with the patient’s mucous membranes, blood, or saliva visibly contaminated with blood. 2. Personnel a. The dental program will appoint a point person responsible for site assessment, fielding questions, training all field personnel, and facilitating follow-up for exposures 3. Assessment a. The point person will conduct an infection control assessment prior to beginning any dental procedures. b. Assessment will follow current OSAP guidelines. Available online at: http://www.osap.org/resource/resmgr/Checklists/OSAP.checklist.portabledent a.pdf?hhSearchTerms=portable+and+dental+and+settings 199 4. Training a. The point person will review all portable site infection control procedures with all staff, volunteers, or other personnel present during the procedures 5. Documentation a. The point person will complete the site assessment worksheet before beginning a new program and at least annually thereafter. b. Exposures will be reported and followed up using the established procedures for the facility. 200 E.4 ORAL HEALTH SURVEILLANCE PURPOSE The purpose of local oral health surveillance is to establish a system that can be used within the community to measure the prevalence and severity of oral diseases, the oral disease burden on the (AI/AN) population, and the impact that our efforts in prevention, education, and early intervention and treatment has made on the population. The Surveillance Plan establishes the core health indicators which will be measured, the frequency of measurement, and comparability with other national oral health surveillance systems. Local surveillance should consider local, state or national data that may be used for comparison and/or determine oral health disparities. PROCEDURE 1. Determine local, state, or national data sources that may be used for comparison. (Consult the National Oral Health Surveillance System at http://www.cdc.gov/nohss/ to find data sources for your state) Possible sources: a. State Basic Screening Survey b. IHS National or Area survey 2. Determine surveillance frequency 3. Determine the target groups for surveillance 4. Determine oral health indicators to be measured and select survey tool such as: a. IHS Oral Health Survey form b. BSS Screening forms (Manual available online at http://www.astdd.org/docs/BSSChildren'sManual20081revised2.9.2010.pdf 5. Contact community partners to schedule screening days and times 6. Select consent (active or passive) methods and distribute appropriate forms 7. Conduct screening, record results, and calculate disease prevalence using simple percentages (This is not as accurate as a weighted sample, but it is within the capabilities of most local programs) 8. Report the findings to local partners, community groups, and clinic administration 201 202