Problematic Compliance Issues Identified by The Joint Commission and CMS Dale Brown, RN, MSN Principal Consultant Kent & Associates Knoxville, Tennessee 2 Accreditation Decisions • Preliminary Accreditation • Accredited • Accredited with follow-up survey (30 days to 6 months) (Non-CMS issues) • Contingent Accreditation: follow up survey within 30 days • Preliminary Denial • Denial 3 Flow of Decision • Accreditation with follow-up survey (1st failed condition level deficiency) • Contingent accreditation (2nd failed CLD) • PDA: Immediate threat to life 4 Flow of Decision • Single or multiple instances • Nature and significance of findings • Failed On-site ESC • Decision rules triggered • Repeat findings 5 Condition Level Deficiencies • Determination based on manner and degree: ▫ Manner: prevalence, how pervasive, number frequency ▫ Degree: magnitude, how severe, how bad ▫ Collaboration among team members AND Central office staff 6 Survey Process Changes • Minimum of 30 records or 10% of ADC whichever is greater. • Small hospitals with ADC less than 20, then 20 records • Small hospital exception does not apply to specialty hospitals. 7 Condition Level Deficiencies • Noncompliance within the condition stem statement • Single requirement out of compliance which is of such magnitude to result in noncompliance with entire condition • Many requirements and standards noncompliant 8 Condition Level Deficiencies • Follow up survey MUST occur within 45 calendar days of last day of accreditation survey • If the problem remains a second follow up survey MUST occur within 30 days of first follow up survey 9 Condition Level Deficiencies • The follow up survey will focus on the RFIs that were determined to be the condition level deficiencies • The surveyors can score other issues that are identified during an onsite visit • Failure to clear a condition level deficiency after the second survey results in notification to CMS 10 Condition Level Deficiencies • Governing Body CoP: ▫ When any condition level deficiencies are identified during the survey, The Joint Commission is required to include a condition level deficiency in the leadership standards. Scoring Decisions 12 Scoring/Decision • The frequency of “Bulleted” points has been reduced. • Elements of Performance and other accreditation requirements will be tagged based on their “criticality” – immediacy of the impact on quality of care and patient safety as the result of noncompliance. • – Direct Impact requirements. • – Indirect Impact requirements. 13 Scoring/Decision • Potentially multiple submission deadlines based on the “immediacy” of risk. • – Direct Impact Requirements: ESC due within 45 days. • – Indirect Impact Requirements: ESC due within 60 days. Scoring/Decision •Partial compliance •Insufficient compliance is not resolved Progressively More Adverse Accreditation 16 Scoring/Decision • The Immediate Threat to Life process has been modified. Upon resolution of the threat, the accreditation status will change from Preliminary Denial of Accreditation (PDA) to Contingent Accreditation and include a follow-up survey. 17 Scoring/Decision • The report which is presented to the organization at the conclusion of the survey will be modified, as follows: • 1. Title changed to – “Summary of Survey Findings” • 2. The report is now sorted by chapters in the applicable Accreditation Manuals 18 Scoring/Decision • 3. The content includes the standards, elements of performance, and other accreditation requirements which have been found to be less than fully compliant at the time of survey, as well as the associated survey team observations. 19 Scoring/Decision • 4. The report does not include a potential accreditation decision. The “official” version of the report which is posted to the organization’s extranet site post-survey will contain the potential accreditation decision. • 5. The report will no longer include “Supplemental Findings” • Name of the survey team is no longer included 20 Scoring/Decision “Immediate Threat to Life” PDA “Situational Decision Rule” Conditional or PDA “Direct Impact Standards” Shorter time frame “Indirect Impact Standards” Longer time frame 21 Immediate Threat to Life • Situations, identified at the time of survey, which have or may potentially have a serious adverse effect on patient health and safety. • The Joint Commission President can issue an expedited Preliminary Denial of Accreditation (PDA) decision. 22 Immediate Threat to Life • PDA remains until corrective action is demonstrated, via an on-site validation survey. • PDA changes to Contingent Accreditation which includes a follow-up survey to assess sustained implementation 23 Situational Decision Rule • Examples: ▫ Unlicensed facility ▫ Unlicensed individual who requires a license ▫ Failure to implement LSC deficiencies • Some standards will trigger a situational decision rule directly and immediately Joint Commission CMS Relationship T J C C M S 25 TJC-CMS • CMS requires accreditation to participate in Medicare and Medicaid programs. • Accreditation can be granted by CMS, States surveying on behalf of CMS, TJC, HFAB, or DNV. 26 TJC-CMS • CMS issues Conditions of Participation. These are regulatory and compliance is not optional. • In order to be accredited, hospitals must comply with CMS Conditions of Participation. 27 TJC-CMS • By having a Joint Commission survey, Joint Commission is “deeming” the hospital to be compliant with CMS. • Not all Joint Commission standards are required by CMS. • Not all CMS Conditions of Participation are reflected in Joint Commission standards. 28 TJC-CMS • Recently Joint Commission has had to release new standards to more closely align itself with CMS, but the revisions are not complete. • Most CMS related TJC standards are “A” elements of performance, requiring 100% compliance. 29 TJC-CMS • If hospitals are found to be noncompliant at a standards level, accreditation can still be awarded. • If hospitals are found non-compliant at a “Condition Level”, then there must be an additional CMS and Joint Commission follow up survey. 30 TJC-CMS • Much focus in consulting is now on CMS in addition to Joint Commission compliance. • Hospitals must always be aware that reporting to external agencies occurs, including CMS, and DEA. • Condition level citations will result in a follow up survey. Three Year Surveys 32 Three Year Surveys • As of January 2011, all surveys will be conducted within a 3 year period (36 months from the last survey) rather than 39 months which was the previous practice. • Laboratory surveys will be continue to be conducted 24 months from the previous survey. 2012 2015 Revised Joint Commission Standards to Align with CMS TJC CMS 34 Changes to reflect the COP • Selected standards were revised to meet relevant Conditions of Participation (CMS) for psychiatric hospitals who use the Joint Commission for Deemed Status which became effective February 1, 2011. • Standards involved EC. 02.03.01, EC. 02.05.03, Emergency Management (EM 03.01.03), Information Management ( IM. 02.02.03), Leadership( 04.01.05), Life Safety Code (LS. 02.01.30), Provision of Care (PC 01.02.13, PC 01.03.01). 35 Environment of Care EC. 02.03.01-Managing Fire Risks • Applicable to Hospitals and Critical Access Hospitals • The organization must have a written fire plan ( LS. 02.01.70, EP. 4) • Cross referencing to the roles of staff, when and how to sound fire alarms , how to contain smoke and fire, fire extinguisher use and evacuation are also referenced at (EC. 03.01.01, EP.2 & HR. 01.04.01, EP 2) 36 Environment of Care EC.02.05.03-Reliable Emergency Electrical Power Source • EP’s 1-6 modified to reflect the change of the NFPA’99, 1999 edition (Section 12-3.3) versus Section 13-3.3 37 Emergency Management EM 03.01.03 • Special Note # 4- In order to satisfy the twicea-year requirement, the hospital must first evaluate the performance of the previous exercise and make any needed modification to its Emergency Operations plan before conducting the subsequent exercise in accordance with the EP’s 13-17. 38 Information Management IM 02.02.03 • The hospital retrieves, disseminates, and transmits health information in useful formats. • Revision: Hospitals that use CMS for deeming – The medical records system allows for timely retrieval of patient information by diagnosis and procedure. 39 Leadership LD. 04.01.05 • The hospital effectively manages its programs, services, sites or departments. • EP # 10 for those psychiatric hospitals that use the Joint Commission for deemed status must comply with having a Director of Social Work who monitors and evaluates the social work services furnished. 40 Life Safety Code LS. 02.01.30 • The note for EP # 6 was removed as follows: Unsealed spaces 1/8 inch wide or less around pipes, conduits, ducts and wires above the ceiling are permitted. • The note for EP # 25 was removed as follows: For The Joint Commission/s accepted amount of alcohol based hand rub permitted within a single smoke compartment was changed to http://www.jointcommisison.org/assets/1/18/accepta ble%20practices%20of%20using%20Alcohol2.pdf 41 Provision of Care PC. 01.02.13 • EP # 2- For psychiatric hospitals that use Joint Commission standards for Deemed Status purposes: Patient’s who receive treatment for emotional and behavioral disorders receive an assessment that includes the following : The reason for admission as stated by the patient and/or others significantly involved in the patient’s care. 42 Provision of Care PC. 01.02.13 • EP # 6- For psychiatric hospitals that use Joint Commission standards for Deemed Status purposes: Based on the patient’s age and needs, the assessment for patients who receive treatment for emotional and behavioral disorders include the following: A complete neurological examination when indicated. 43 Provision of Care PC. 01.03.01-Planning Care • EP. # 5-For psychiatric hospitals that use Joint Commission standards for Deemed Status purposes: The written plan of care is based on patient’s goals and the time frames, setting, and services required to meet those goals. The patient’s goals include both short-term and long-term goals. • EP. #43-The plan of care includes the responsibilities of each member of the treatment team. Testing Fire Protection Systems 45 EC. 02.03.05 Maintenance of Fire Safety Equipment • Changes will be in effect July 1, 2011 unless otherwise dictated by CMS. • For hospitals using the Joint Commission for Deemed status purposes: • EP # 2-At least quarterly the hospital tests water-flow devices. (Was every 6 months) 46 EC. 02.03.05 Maintenance of Fire Safety Equipment • EP # 25-Documentation of maintenance, testing, and inspection activities for fire alarm and water-based fire protection systems includes the following: – Name of the activity – Date of the activity – Required frequency of the activity – Name and contact information, including affiliation of the person who performed the activity – Results of the activity. 47 EC. 02.03.05 Maintenance of Fire Safety Equipment • Additional guidance may be found at NFPA 24, 1998 edition (Section2-1.3) and NFPA 72. 1999 Edition (Section 7-5.2) CMS New Department Requirements 49 RADIOLOGY • New CMS requirements for oversight of radiology. • Policies and procedures must comply with nationally recognized standards: ACR • Physician supervision of all contrast administration (CT and MRI). • Physician must be permitted by director of radiology to use radiology equipment. 50 RADIOLOGY • Training of all providers who operate radiology equipment: physicians and staff using C-Arm, Fluoroscopy. ANESTHESIA 52 ANESTHESIA • • • 1: Director of Anesthesia Services 2: “Deep Sedation” now considered anesthesia and is referred to a Monitored Anesthesia Care. 3: MAC may only be administered only by an appropriate practitioner privileged by director of anesthesia services 53 ANESTHESIA • • • 4: Director of anesthesia responsible for all anesthetics (general to local). 5: Director of anesthesia services sets policies for all anesthetic use. 6: Director of anesthesia services decides on how to privilege for moderate sedation. 54 ANESTHESIA • • 7: Epidurals administered by CRNAs do not require direct supervision unless they become an anesthetic. 8: Post-anesthesia note may be written from the time a patient can participate until discharge or 48 hours whichever comes sooner. 55 ANESTHESIA • Practical effects: ▫ Nursing staff will no longer be able to administer anesthesia agents: Etomidate, Ketamine, Pentothal, or Propofol because this is MAC. ▫ Anesthesia will have to privilege for MAC (deep sedation), and recommend privileging process for moderate sedation 56 ANESTHESIA • Reference: S&C-10-09-Hospital • Tag: A-1000 • §482.52 Telemedicine CMS REQUIREMENTS 58 Definitions • Hospital: location where patient receives telemedicine services • Distant Site: where the physician is remotely who is providing services • Entity: a non-hospital providing location Governing Body & Relationship with Hospital Hospital Agreement with distant site Distant site is a “contractor” for services Governing Body Distant site provides services allowing hospital to be compliant Distant site responsible for compliance Local hospital may allow use of documents provided by distant site 60 Medical Staff Medical staff may rely on credentialing and privileging decision of distant site (proxy). • 1). Distant site must be Medicare-participating hospital. • 2). Privileged at distant site, and list provided to hospital. • 3). Individual holds license in state where patients are located. 61 Medical Staff • 4). Hospital performs internal review of performance and sends to “distant site.” • 5). Includes all adverse events and complaints. 62 Requirements of MEDICAL STAFF if the “distant site” is a non-Medicare participating “entity” • 1). Agreement requires that the services be furnished in a manner that permits the hospital to be in compliance with CMS requirements. • 2). Distant entity credentialing and privileging process meets CMS standards. • 3). Distant entity providers privilege list/delineations. • 4). Holds license in state where patient located. • 5). Hospital sends performance review to distant entity. • 6). Criteria for privileging established. Patient Rights 64 RI.01.07.01 The patient and his or her family have the right to have complaints and grievances reviewed by the organization. 65 RI.01.07.01 • 6-M,C: The hospital acknowledges receipt of a complaint that the hospital cannot resolve immediately and notifies the patient of follow up to the complaint. RI.01.07.01 18-M, D, C- In its resolution of complaints, the hospital provides, the individuals with a written notice of its decision, which contains the following: 11/3/2525 Dear Ms. Concern: Mr. Care (contact person) has been appointed the contact person for your situation. On your behalf, we have taken the following steps to investigate your situation… The results of this process are… As of November 3, 2525, we are now considering that this matter is resolved (date complaint process completed) 67 RI.01.07.01 • 19-A: The hospital determines time frames for grievance review and response. 68 RI.01.07.01 • 20-A: The process for resolving grievances includes a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the Quality Improvement Organization (QIO). Medical Staff MS. 01.01.01 • Many individual requirements to be found in the Medical Staff Bylaws. • EP # 12: The structure of the medical staff. (CMS CoP requirement) • EP #13: Qualifications for appointment to the medical staff. (CMS CoP requirement) • EP #14: The process for privileging and reprivileging licensed independent practitioners, which may include the process for privileging and re-privileging other practitioners. (CMS CoP requirement) 71 15: A statement of the duties and privileges related to each category of the medical staff (for example, active, courtesy). (CMS CoP requirement) Note: The word “privileges” can be interpreted in several ways. The Joint Commission interprets it, solely for the purposes of this element of performance, to mean the duties and prerogatives of each category, and not the clinical privileges to provide patient care, treatment, and services related to each category. The Joint Commission is in discussion with CMS to clarify this term’s meaning. 72 16: The requirements for completing and documenting medical histories and physical examinations. The medical history and physical examination are completed and documented by a physician, an oral maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. (CMS CoP requirement) Provision of Care, Treatment, and Services 74 PC. 02.01.03 The organization provides care, treatment, and services as ordered or prescribed, and in accordance with law and regulation. 75 PC. 02.01.03 Elements of Performance 1-DI, A: Prior to providing care, treatment, and services, the hospital obtains or renews orders (verbal or written) from a licensed independent practitioner in accordance with professional standards of practice and law and regulation. 7-DI, A: The hospital provides care, treatment, and services using the most recent patient order (s). 76 PC.02.01.03 14-DI, A: Respiratory services are provided only on, and in accordance with, the orders of a doctor of medicine or osteopathy. 77 PC.03.01.03 The organization provides the patient with care before initiating operative or other high-risk procedures, including those that require the administration of deep sedation or anesthesia. 78 PC.03.01.03 18-DI, A: A pre-anesthesia evaluation is completed and documented by an individual qualified to administer anesthesia within 48 hours prior to surgery or a procedure requiring anesthesia services. 79 PC. 03.01.07 The organization provides care to the patient after operative or other high-risk procedures and/or the administration of moderate or deep sedation or anesthesia. 80 PC.03.01.07 Elements of Performance 7-DI, A: A post-anesthesia evaluation is completed and documented by an individual qualified to administer anesthesia no later than 48 hours after surgery or a procedure requiring anesthesia services. 81 PC. 03.01.07 Elements of Performance 8-DI, A: The post-anesthesia evaluation for anesthesia recovery is completed in accordance with law and regulation and policies and procedures that have been approved by the medical staff. Restraints PC.03.05.03 The hospital uses restraint or seclusion safely • The use of restraint and seclusion is in accordance with a written modification to the patient's plan of care. Imminent Jeopardy CMS Examples Actual injury NOT required to occur for a citation 85 CMS: Abuse • Failure to protect from abuse • 1. Serious injuries such as head trauma or fractures; • 2. Non-consensual sexual interactions; e.g., sexual harassment, sexual coercion or sexual assault; • 3. Unexplained serious injuries that have not been investigated; 86 CMS: Abuse • 4. Staff striking or roughly handling an individual; • 5. Staff yelling, swearing, gesturing or calling an individual derogatory names; • 6. Bruises around the breast or genital area; or Suspicious injuries; e.g., black eyes, rope marks, cigarette burns, unexplained bruising. 87 CMS: Neglect • Lack of timely assessment of individuals after injury; • Lack of supervision for individual with known special needs; • Failure to carry out doctor’s orders • Repeated occurrences such as falls which place the individual at risk of harm without intervention; 88 CMS: Neglect • Access to chemical and physical hazards by individuals who are at risk; • Access to hot water of sufficient temperature to cause tissue injury; • Non-functioning call system without compensatory measures; • Unsupervised smoking by an individual with a known safety risk; 89 CMS: Neglect • Lack of supervision of cognitively impaired individuals with known elopement risk; • Failure to adequately monitor individuals with known severe self-injurious behavior; 90 CMS: Neglect • Failure to adequately monitor and intervene for serious medical/surgical conditions; • Use of chemical/physical restraints without adequate monitoring; • Lack of security to prevent abduction of infants; • Improper feeding/positioning of individual with known aspiration risk 91 CMS: Infection/Sterility • Pattern of ineffective infection control precautions; or • High number of nosocomial infections caused by cross contamination from staff and/or equipment/supplies. 92 CMS: Fire/Hazards • 5. Widespread lack of knowledge of emergency procedures by staff; • 6. Widespread infestation by insects/rodents; • 7. Lack of functioning ventilation, heating or cooling system placing individuals at risk; Frequently Cited Standards First 6 months 2011 Data 94 RC.01.01.01 The hospital maintains complete and accurate medical records. 2010 65% EP: 11,19 (Date/Time), EP 4, 9 (Patient ID, Continuity of Care) First 6 Months 2011 69% EP: 11,19 (Date/Time), EP 4, 9 (Patient ID, Continuity of Care) Factors: dating/timing entries: CMS requirement 95 LS.02.01.20 The hospital maintains the integrity of the means of egress 2010 51% EP 13, 30, 31 First 6 Months 2011 57% EP 13, 30, 31 Factors: Corridor storage, exit signs, 30 minute rule, “computers on wheels”. IMMEDIATE THREAT POTENTIAL 96 LS.02.01.10 Building and Fire protection features are designed and maintained to minimize the effects of fire, smoke, and heat. 2010 49% EP 4, 5 First 6 months 2011 57% EP 4, 5 Factors: Fire and smoke doors, penetrations IMMEDIATE THREAT POTENTIAL.. 97 LS.02.01.30 The hospital provides and maintains building features to protect individuals from the hazards of fire and smoke. 2010 40% EP: 2, 11, 18 First 6 months 2011 47% EP: 2, 11, 18 Factors: Hazardous areas like boiler rooms, flammable liquid storage rooms, laboratories, piped oxygen tank supply rooms, dampers, corridor doors 98 EC.02.03.05 The hospital maintains fire safety equipment and fire safety building features. 2010 42% All EPs First 6 months 2011 42% All EP’s Factors: inspecting, testing and maintaining various features of fire protection – Includes fire alarms, sprinklers, portable fire extinguishers, tamper switches, etc. 99 IC.02.02.01 Infection risk: equipment, supplies, devices 2010 29% EP: 2, 4 First 6 months 2011 36% EP: 2, 4 Factors: Flash autoclaving, cleaning, high level disinfecting, QC checks, and equipment storage. 100 RC.02.03.07 Qualified staff receive and record verbal orders 2010 33% EP: 4 First 6 months 2011 36% EP: 4 Factors: Authentication within 48 hours, Law and regulation. Un-authorized individuals taking and transmitting verbal orders. 101 MM.03.01.01 The hospital safely stores medications. 2010 31% EP 2, 3, 6 First 6 months 2011 34% EP 2, 3, 6 Factors: medication storage, manufacturer’s guidelines, security, potential for diversion, control between receipt and administration, expired medication 102 LS. 02.01.35 The hospital provides and maintains systems for extinguishing fires. Not a frequently scored Recommendation for Improvement in 2010 First 6 months 2011 33% EP: 2, 4, 5 Factors: Storage <18 inches from sprinkler heads, damaged sprinkler heads, Fire extinguishers within 30 ft of grease producing cooking devices 103 PC.01.02.03 The hospital assesses and reassesses the patient and his or her condition according to defined time Not a frequently First 6 months 2011 scored 33% Recommendation EP: 2, 4, 5 for Improvement in 2010 Factors: H&Ps present, H&Ps within 30 days, Updates with correct CMS wording.