Problematic Compliance Issues Identified by The Joint Commission and CMS

1. 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 2

3. Flow of Decision Accreditation with follow-up survey (1st failed condition level deficiency) Contingent accreditation (2nd failed CLD) PDA: Immediate threat to life 3

4. Flow of Decision Single or multiple instances Nature and significance of findings Failed On-site ESC Decision rules triggered Repeat findings 4

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 5

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. 6

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 7

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 8

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 9

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. 10

11. 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. 12

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. 13

14. Scoring/Decision Partial compliance Insufficient compliance is not resolved

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. 16

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 17

18. 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 19

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 20

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. 21

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 22

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 23

24. Joint CommissionCMS Relationship

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. 25

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. 26

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. 27

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. 28

29. TJC-CMS If hospitals are found to be non-compliant 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. 29

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. 30

31. 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. 32

33. Revised Joint Commission Standards to Align with 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). 34

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) 35

36. Environment of CareEC.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 36

37. Emergency Management EM 03.01.03 Special Note # 4- In order to satisfy the twice-a-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. 37

38. Information ManagementIM 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. 38

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. 39

40. Life Safety CodeLS. 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/acceptable%20practices%20of%20using%20Alcohol2.pdf 40

41. Provision of CarePC. 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. 41

42. Provision of CarePC. 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. 42

43. Provision of CarePC. 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. 43

44. Testing Fire Protection Systems

45. EC. 02.03.05Maintenance 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) 45

46. EC. 02.03.05Maintenance 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. 46

47. EC. 02.03.05Maintenance 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) 47

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. 49

50. RADIOLOGY Training of all providers who operate radiology equipment: physicians and staff using C-Arm, Fluoroscopy. 50

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 52

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. 53

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. 54

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 55

56. ANESTHESIA Reference: S&C-10-09-Hospital Tag: A-1000 §482.52 56

57. 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 58

59. Governing Body & Relationship with Hospital

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. 60

61. Medical Staff 4). Hospital performs internal review of performance and sends to “distant site.” 5). Includes all adverse events and complaints. 61

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. 62

63. 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. 64

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. 65

66. 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:

67. RI.01.07.01 19-A: The hospital determines time frames for grievance review and response. 67

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). 68

69. Medical Staff

70. 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 re-privileging licensed independent practitioners, which may include the process for privileging and re-privileging other practitioners. (CMS CoP requirement)

71. 71

72. 72

73. 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. 74

75. PC. 02.01.03Elements 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). 75

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. 76

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. 77

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. 78

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. 79

80. PC.03.01.07Elements 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. 80

81. PC. 03.01.07Elements 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. 81

82. Restraints

83. 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.

84. 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; 85

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. 86

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; 87

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; 88

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; 89

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 90

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. 91

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; 92

94. RC.01.01.01The hospital maintains completeand accurate medical records. 94

95. LS.02.01.20The hospital maintains theintegrity of the means of egress 95

96. LS.02.01.10Building and Fire protection features are designed and maintained to minimize the effects of fire, smoke, and heat. 96

97. LS.02.01.30The hospital provides andmaintains building features to protectindividuals from the hazards of fire and smoke. 97

98. EC.02.03.05The hospital maintains fire safetyequipment and fire safety building features. 98

99. IC.02.02.01Infection risk: equipment, supplies, devices 99

100. RC.02.03.07Qualified staff receive and recordverbal orders 100

101. MM.03.01.01The hospital safely storesmedications. 101

102. LS. 02.01.35The hospital provides and maintains systems for extinguishing fires. 102

103. PC.01.02.03The hospital assesses and reassesses the patient and his or her condition according to defined time 103