Federation of Electrodiagnostic Laboratory Accreditation Laboratory Accreditation Self Study PROVIDER Provider: The following criteria relate to provider requirements P-1. Each accredited laboratory must designate a provider with the title of Laboratory Director. Narrative: Build a case that the laboratory director is a competent director. Document clinical experience, training, leadership abilities/experience, board certification, continuing education, and other qualities the support the position of director. Comment on current patient case load (studies per month). Appendices P1: - CV of laboratory director which includes continuing education - Copy of state licensure, board certification certificate - Copy of any diploma or completion certificate(s) of residency or other significant formal training (see definition of formal training in the glossary) experience in clinical electrophysiology (as appropriate for other professional providers other than the director) - Copies of basic provider level CPR training Requirement Evidence (rows below for reviewer use only) Formal training Years of experience as a clinician (5 minimum) Years of experience as an Electromyographer (3 minimum) Board Certification (ABPTS* or ABEM+ required); Copies of license, certifications, and/or residencies completed Leadership experience Basic provider CPR *American Board of Physical Therapy Specialties + American Board of Electrodiagnostic Medicine P-2. Each accredited laboratory is permitted to employ professional providers to perform complete clinical electrophysiological examinations (as allowed by state law). Narrative: Summarize the state's scope of practice laws regarding providers in the laboratory that perform and interpret complete EMG/NCV studies. Appendices P2: - Excerpts from state practice acts that demonstrates EMG/NCV clinical practice is within the scope of the providers in the laboratory - Copy of state licensure, board certification certificate (as appropriate for other professional providers other than the director) - Copy of any diploma or completion certificate(s) of residency or other significant formal training (see definition of formal training in the glossary) experience in clinical electrophysiology (as appropriate for other professional providers other than the director) Copyright American Academy of Clinical Electrodiagnosis - Copies of basic provider level CPR training (as appropriate for other professional providers other than the director) Requirement State practice act is consistent with licenses/qualifications of providers Copies of license, certifications, residencies, and/or certificates of formal training of each provider (other than laboratory director) Basic provider CPR for each provider Evidence (Rows below for reviewer use only) P-3. Each accredited laboratory is permitted to employ certified technicians to perform nerve conduction studies under the direction and on-site supervision (see definition of direction and onsite supervision in the glossary) of the laboratory director or designee. The supervisor must be a professional, licensed health care provider, appropriately trained in EMG/NCV (meets either criteria in P-1 or P-2), and be immediately available to the technician. Narrative: Summarize the state's laws regarding performance of nerve conduction studies by a technician under on-site supervision of a licensed health care provider. Document the type of formal training (see definition of formal training in the glossary) the certified technician underwent. Comment whether or not the technician has had his/her competency evaluated by the laboratory director or his/her representative (must meet criteria in P1 or P2). Appendices P3: - Excerpts from state practice acts that demonstrates EMG/NCV clinical practice is within the scope of the providers in the laboratory (specifically technicians) - Copy of diploma or completion certificate with active technician certification number demonstrating certification in the performance of nerve conduction studies. - Copy of high school diploma or equivalent - Document that confirms competency in the various nerve conduction techniques (evaluation rubric or indicate the page number(s) in the policy and procedure manual that states how technician competency is determined) - Copies of Basic provider level CPR training Requirement Evidence (Rows below for reviewer use only) State law is consistent with laboratory's use of technicians Copy of diploma or completion certificate with active technician certification number for each technician Copy of high school diploma or equivalent for each technician Documentation of competency Copyright American Academy of Clinical Electrodiagnosis within the current laboratory Basic provider CPR for each provider P-4. Each accredited laboratory is permitted to employ non-certified technicians to perform nerve conduction studies under the direction and on-site supervision (see definition of direction and on-site supervision in the glossary) of the laboratory director or designee. The supervisor must be a professional, licensed health care provider, appropriately trained in EMG/NCV (meets either criteria in P-1 or P-2), and be immediately available to the technician. Narrative: Summarize the state's laws regarding performance of nerve conduction studies under direct supervision of a licensed health care provider. Document the type of formal training (see definition of formal training in the glossary) the technician underwent. Comment whether or not the technician has had his/her competency evaluated by the laboratory director or his/her representative (must meet criteria in P1 or P2). Appendices (P4): - Excerpts from state practice acts that demonstrates EMG/NCV clinical practice is within the scope of the providers in the laboratory (specifically technicians) - Copy of high school diploma or equivalent - Document that confirms competency in the various nerve conduction techniques (evaluation rubric or indicate the page number(s) in the policy and procedure manual that states how technician competency is determined) - Copies of Basic provider level CPR training Requirement Evidence (Rows below for reviewer use only) State law is consistent with laboratory's use of technicians Documentation of formal training Copy of high school diploma or equivalent for each technician Documentation of competency within the current laboratory Basic provider CPR for each provider P-5. Licensed health care providers complete thorough reports of EMG/NCV studies Appendices P5: For each licensed health care provider who is NOT board certified by the American Board of Physical Therapy Specialties or the American Board of Electrodiagnostic Medicine, provide three complete reports to include one of each of the following: entrapment neuropathy, radiculopathy or plexopathy, and polyneuropathy. Requirement Copies of the following studies provided: entrapment neuropathy, radiculopathy or plexopathy, and polyneuropathy Evidence (Rows below for reviewer use only) Copyright American Academy of Clinical Electrodiagnosis Scores a minimum of 70% for each study on the score sheets (appendices) P-6. All licensed health care providers and technicians provide evidence of continuing education. Continuing education can be formal courses, journal club, or similar activities Appendices P6: Provide a listing of continuing education activities for each licensed health care provider. This can be presented in table format if desired. Twenty-four contact hours are the minimum required each three years. Requirement Continuing Education in EMG/NCV and/or neuromuscular related education (24 hours in last 3 years required). Provided for each clinician Evidence (Rows below for reviewer use only) Copyright American Academy of Clinical Electrodiagnosis SUPERVISION AND ADMINISTRATION Supervision and Administration: The following criteria relate to supervision and administration SA 1. There is a clearly communicated organizational chart so all personnel involved in the provision of EMG/NCV services understand the chain of command. Satellite facilities should be included in this organizational chart. Narrative: indicate where in the policy and procedure manual an organizational chart can be found. Requirement Organizational chart present that clearly depicts leadership and relationships among different clinics. Page # Evidence (rows below for reviewer use only) SA 2. There is a clear job description/responsibilities of each of the following types of providers (as appropriate for your laboratory): laboratory director, board certified provider, non-board certified provider, NCV technicians. Narrative: indicate where in the policy and procedure manual these job descriptions can be found. If the laboratory does not utilize some of the above providers, please indicate so. Requirement Page # Laboratory Director Position Description (PD) Board certified provider PD Non-board certified provider PD Technician provider PD PDs are consistent with supervision requirements noted in SA 3. Evidence (Rows below for reviewer use only) SA 3. Supervision requirements are clearly spelled out for technicians and non-board certified providers. Narrative: Technicians: Describe the process of a patient encounter when a nerve conduction technician is used. Include the following: 1) indicate when the patient is examined by a licensed provider, 2) who makes the decision as to what specific nerves will be tested, 3) when/how is the NCV data reviewed by the licensed provider, 4) when and if a needle EMG is performed and who performs the EMG exam, 5) the location of the supervising licensed provider when an NCV technician is Copyright American Academy of Clinical Electrodiagnosis performing the exam. Also describe how licensed providers respond to questions an NCV technician may have in the middle of an EMG/NCV exam. Non-board certified licensed health care providers: Comment on supervision of non-board certified licensed health care providers. Include whether supervision is on-site or distance; also include your peer review process of non-board certified licensed health care providers. Also indicate where these policies can be found in the policies and procedures manual. If the laboratory does not use NCV technicians and non-board certified providers, just indicate so. Requirement Supervision is direct and appropriate for technicians Supervision is appropriate for non-board certified licenses providers Evidence (Rows below for reviewer use only) SA 4. NCV technicians and non-board certified licensed providers have competency verified by board certified providers. Narrative: Describe how the laboratory verifies that an NCV technician and non-board certified providers are competent to perform various NCV and/or EMG procedures. Appendices SA 4: grading rubrics or check-off sheets used to document competency (may be the same documents used for criteria P3 and P4). Requirement Procedures to assure competency for technician providers is appropriate Procedures to assure competency for non-board certified licensed providers is appropriate Evidence (Rows below for reviewer use only) SA 5. There is a medical record retention policy in the facility. Narrative: Describe the medical record retention policy and indicate if the policy is consistent with state law (length of time held, method of storage, etc.). Indicate where in the policy and procedure manual this policy can be found. Also state whether medical records are electronic or paper. Requirement An appropriate medical retention policy is evident Evidence (Row below for reviewer use only) SA 6. There is a HIPAA compliance policy. At a minimum, the facility’s HIPAA Policies and Procedures should establish a formal information privacy and security training program and set forth the person who has responsibilities for determining training requirements and conducting the training, the content and frequency of training, and the proper documentation of attendance at Copyright American Academy of Clinical Electrodiagnosis training sessions. Note: the facility can establish the appropriate frequency of training for their facility unless changes in HIPAA policy occur. Narrative: Indicate where in the policy and procedure manual the HIPAA compliance policy can be found. Appendices SA 6: include documentation of HIPAA compliance training or all providers in the laboratory. Requirement An appropriate HIPAA policy is evident Evidence (Row below for reviewer use only) SA7: Each provider and staff person in the laboratory must have evidence of Fraud, Waste and Abuse Prevention compliance training every three years. There must be a clearly identified compliance officer or contact person for laboratory staff to report potential or real problems (the contact person may be a member of the clinic staff in which the laboratory is housed). Requirement Documentation of policy concerning fraud, waste and abuse compliance training in the policy and procedures manual Fraud, waste and abuse contact person identified Evidence of training of all laboratory personnel supplied Page # Evidence (Row below for reviewer use only) SA8: The facility must have a policy and process for managing supplies (ordering, replacing expired supplies, etc.) and indicate the person responsible for managing supplies/equipment. Narrative: Please state where this can be found in the in the policy and procedure manual. Requirement An appropriate supply management policy is evident Page # Evidence (Row below for reviewer use only) SA9: The facility must have a process for acquiring annual electrical checks and certification of electrical safety for all machines used by the main facility and satellite clinic(s). Note: All laboratories must provide documentation of at least one electrical check within the last year prior to accreditation. Narrative: Please state where the policy regarding electrical checks can be found in the in the policy and procedure manual. Copyright American Academy of Clinical Electrodiagnosis Appendices SA9: Provide documentation of an electrical check for each piece of equipment used for EMG/NCV testing within the last year. Requirement An appropriate electrical safety policy is evident Documentation of electrical check(s) are provided Page # Evidence (Row below for reviewer use only) SA10: For laboratories where more than one person is employed in the performance of EMG/NCV studies, there must be a human resources policy that indicates hiring and termination policies. These policies should also include: hours of work, probationary periods (if any), annual performance review requirements, grievance procedures, employment benefits, vacation and sick leave, workers compensation benefits, and similar policies. Appendices SA9: human resources manual (note: for laboratories where only one person is employed, this is not necessary). Requirement Human resource policies are evident and appropriate Evidence (Row below for reviewer use only) Copyright American Academy of Clinical Electrodiagnosis PATIENT CARE Patient Care: The following criteria relate to policies regarding patient care PC1: The facility has a procedure handbook that details the general procedures for performance of NCV and EMG procedures performed in the laboratory. This handbook (with references) should include general procedures for: Motor and sensory NCS, F-waves, H reflexes, mixed NCV studies, EMG, Blink reflex, others if performed by the clinic. Appendices PC1: include the procedures handbook. Requirement Procedures are consistent with current standards of care Evidence (Row below for reviewer use only) PC2: The facility has a document that details the normal values used for NCV and EMG procedures performed in the laboratory. Normal values must be referenced. Appendices PC2: include the normal values document. Requirement A referenced normal values table is provided Evidence (Row below for reviewer use only) PC3: The policy and procedure manual list the procedures followed during medical emergencies, who is responsible to perform emergency procedures, and what equipment is available for use in these situations (crash cart, de-fibrillator, etc.). Narrative: Indicate in the procedure manual where these policies can be found. Requirement Appropriate medical emergency procedures are evident Evidence (Row below are for reviewer use only) PC4: There is a universal precautions and blood borne pathogens policy in the policy and procedure manual. Narrative: Indicate in the procedure manual where these policies can be found. Requirement An appropriate universal precautions and blood borne pathogens policy is evident Evidence (Rows below for reviewer use only) PC5: Number and type of studies performed in the main clinic and satellite facilities. Narrative: State the approximate number of studies performed in the main clinic and each satellite facility. Also include the percentage of entrapment neuropathies, radiculopathies, polyneuropathies, and other (myopathy, NMJ disorder, plexopathy, etc.). Also indicate the percentage of studies that have both EMG and NCV procedures performed, percentage performed by a technician, and percentage where the studies are performed on site and interpreted offsite. A table with this data may be helpful to insert below. Copyright American Academy of Clinical Electrodiagnosis Requirement A minimum of 50 studies are performed each year by each licensed health care provider There is an adequate variety of patients (entrapment neuropathy, polyneuropathy, radiculopathy/plexopathy, myopathy/NMJ disorders) 90% of the studies have both EMG/NCV performed 90% of the studies are performed and interpreted on site (not interpreted by a 3rd party) Evidence (Rows below for reviewer use only) PC6: The laboratory monitors outcomes. Appendices: List the types of outcome assessment performed. This can include patient satisfaction surveys, referring physician satisfaction surveys, peer review, or similar activities. Requirement There is adequate monitoring of outcomes Evidence (Row below for reviewer use only) Copyright American Academy of Clinical Electrodiagnosis FACILITY Facility: The following criteria relate to facility requirements F1: State whether the laboratory is compliant with the American Disabilities Act Narrative: Describe how the facility (main and satellite clinics) are compliant. Requirement Laboratory is fully accessible and compliant with ADA Evidence (Row below for reviewer use only) F2: Describe the general types of facilities the main clinic and satellite clinics have. Narrative: State if the facility has the following: restrooms for patients and staff, number of exam rooms used for EMG/NCV, patient waiting room, secured file room for medical records, break room for staff, and secure areas to store personal belongings. Requirement The facility has all of the rooms/items noted in the criteria above Evidence (Row below for reviewer use only) F3: Provide a listing of all equipment used for EMG/NCV testing. Narrative: Include the following for capital expense equipment: manufacturer, model number, date put in use. For other supplies, indicate the types of electrodes used for EMG and NCV, and related supplies. A table may be helpful to display this data. Requirement The facility has necessary equipment/supplies to perform complete EMG/NCV studies. Evidence (Row below for reviewer use only) F4: Fire safety and evacuation plan for the main laboratory and any satellite laboratories. These policies must include: procedures for reporting fires and similar emergencies, evacuation routes, procedures to account for all employees and patients after an emergency evacuation has been conducted, and location of fire extinguisher(s) and maintenance plan. Note: the OSHA website may be helpful in developing these policies – www.osha.gov) Appendices F4: Include this emergency preparedness document. Requirement Emergency procedures are thorough and adequately described Evidence (Row below for reviewer use only) F5: The facility must have a plan for power outages and methods for surge protection. Note: if the facility has an uninterrupted electrical supply and surge protection in place, this statement is all that is needed. Copyright American Academy of Clinical Electrodiagnosis Narrative: Indicate whether or not the facility has an uninterrupted power supply and surge protection. Appendices F5: If the facility does not have uninterrupted power supply and/or surge protection, please include policies used when an electrical outage occurs or when there is potential for an electrical outage to occur (storm). Requirement The facility has an uninterrupted power supply (back up generator) and surge protection If the facility does not have an uninterrupted power supply, describe policies following when an electrical outage occurs. Evidence (Rows below for reviewer use only) Copyright American Academy of Clinical Electrodiagnosis Part Five – Glossary Formal Training: Structured learning activities that progress from simple to complex taught by board certified clinicians (American Board of Physical Therapy Specialties or American Board of Electrodiagnostic Medicine) or clinicians with a minimum of 5 years experience. The program must have stated objectives that cover all aspects of electrodiagnostic to include motor nerve conduction studies (NCS), sensory NCS, late response (F-waves, H reflexes), needle electromyography, classification and pathophysiology of peripheral neuromuscular disease, and critical thinking. The program must assess competency of the students in all aspects of electrodiagnostic as noted above. General Supervision: The supervisor can be off-site but is available by phone. Peer review of studies completed is completed on a regular basis. On-site supervision: The supervisor is in the same building where the trainee or supervised provider is performing clinical work. The supervisor can be in the same room as the supervised provider in less than 5 minutes. Qualifying continuing education: Structured learning activities taught by board certified clinicians or clinicians with a minimum of 5 years experience. The program must have stated objectives. Substantive Change: Any change that would significantly alter the function of the laboratory. Examples include: change of laboratory director, change of primary facility, and the addition of satellite facilities. Under the direction: The supervising clinician has detailed knowledge of the patient being assessed through taking a history and performing a physical examination. The supervising clinician then orders the licensed clinician or technician to perform specific nerve conduction tests and/or EMG testing, as applicable. Copyright American Academy of Clinical Electrodiagnosis