INTRODUCTION ___________________________________________________________________________________ 10
Terminology ______________________________________________________________________________________ 12
Acronyms / Abbreviations __________________________________________________________________________ 15
Module I
Governance Standards __________________________________________________________________________ 17
1 Regulatory Compliance__________________________________________________________________________ 19
1.1 General__________________________________________________________________________________ 19
2 Leadership ____________________________________________________________________________________ 20
2.1 Legal Authority and Governing Body __________________________________________________________ 20
2.2 Managing Director _________________________________________________________________________ 20
2.3 Medical Director __________________________________________________________________________ 21
2.4 Healthcare Providers _______________________________________________________________________ 21
2.5 Organizational Plan and Budget ______________________________________________________________ 21
2.6 Outsourced Services _______________________________________________________________________ 22
3 Organizational Ethics____________________________________________________________________________ 23
3.1 General__________________________________________________________________________________ 23
3.2 Discrimination and Work Environment_________________________________________________________ 24
4 Quality Management System _____________________________________________________________________ 25
4.1 General__________________________________________________________________________________ 25
4.2 Quality Management System Requirements ____________________________________________________ 26
4.3 Quality Policy, Mission, Vision, and Values______________________________________________________ 26
4.4 Control of Documented Information __________________________________________________________ 27
4.5 Quality Objectives and Plan__________________________________________________________________ 27
4.6 Measurement, Monitoring, and Analysis _______________________________________________________ 28
4.7 Management Review _______________________________________________________________________ 29
5 Utilization Review ______________________________________________________________________________ 31
5.1 Utilization Review Plan ______________________________________________________________________31
5.2 Scope and Frequency of Review _______________________________________________________________31
5.3 Department Scope of Service ________________________________________________________________ 32
6 Patient Safety System ___________________________________________________________________________ 33
6.1 General__________________________________________________________________________________ 33
6.2 Traceability_______________________________________________________________________________ 33
6.3 Opioid Oversight and Use Committee _________________________________________________________ 34
7 Staffing Management ___________________________________________________________________________ 36
7.1 Licensure, Registration and Certification _______________________________________________________ 36
7.2 Professional Scope_________________________________________________________________________ 36
7.3 Determining and Modifying Staffing___________________________________________________________ 36
7.4 Job Description____________________________________________________________________________ 36
7.5 Orientation_______________________________________________________________________________ 36
7.6 Staff Competence _________________________________________________________________________ 37
7.7 Awareness and Education ___________________________________________________________________ 37
7.8 Staff Evaluations __________________________________________________________________________ 38
7.9 Health Promotion__________________________________________________________________________ 38
8 Medical Staff __________________________________________________________________________________ 39
8.1 General__________________________________________________________________________________ 39
8.2 Medical Staff Organization, Accountability, and Responsibility _____________________________________ 39
8.3 Qualification Description of the Medical Staff ___________________________________________________ 40
8.4 Performance Data _________________________________________________________________________ 40
8.5 Continuing Education________________________________________________________________________41
8.6 Clinical Privileges ___________________________________________________________________________41
8.7 Temporary Clinical Privileges_________________________________________________________________ 42
8.8 Disciplinary or Rehabilitation Action___________________________________________________________ 43
8.9 History and Physical________________________________________________________________________ 43
8.10 Consultation______________________________________________________________________________ 43
9 Nursing Services _______________________________________________________________________________ 44
9.1 General__________________________________________________________________________________ 44
9.2 Personnel ________________________________________________________________________________ 44
9.3 Staffing and Delivery of Care_________________________________________________________________ 44
9.4 Licensure ________________________________________________________________________________ 45
9.5 Planning _________________________________________________________________________________ 45
10 Risk Management ______________________________________________________________________________ 47
10.1 Planning, Assessment, and Treatment _________________________________________________________ 47
10.2 Monitoring and Review _____________________________________________________________________ 48
Module II
Patient Focused Care____________________________________________________________________________ 49
11 Patient’s Rights ________________________________________________________________________________ 51
11.1 General___________________________________________________________________________________51
11.2 Informed Consent _________________________________________________________________________ 52
11.3 Patient Grievance__________________________________________________________________________ 53
11.4 Language and Communication _______________________________________________________________ 54
11.5 Family Member Notification _________________________________________________________________ 54
11.6 Right to Personal Privacy ____________________________________________________________________ 54
11.7 Safety ___________________________________________________________________________________ 55
11.8 Abuse, Harassment and Mobbing _____________________________________________________________ 55
11.9 Patient Property___________________________________________________________________________ 55
11.10 Confidentiality of Patient Records ____________________________________________________________ 55
11.11 Restraint and/or Seclusion __________________________________________________________________ 56
11.12 Order for Restraint or Seclusion ______________________________________________________________ 57
11.13 Staff Training for Restraint and/or Seclusion ____________________________________________________ 58
11.14 Quality Monitoring_________________________________________________________________________ 59
12 Planning, Admission and Discharge _______________________________________________________________ 60
12.1 General__________________________________________________________________________________ 60
12.2 Planning and Admission ____________________________________________________________________ 60
12.3 Discharge _________________________________________________________________________________61
12.4 Patient Transfer or Referral ___________________________________________________________________61
13 Outpatient Services_____________________________________________________________________________ 62
13.1 General__________________________________________________________________________________ 62
13.2 Organization______________________________________________________________________________ 62
14 Surgical Services _______________________________________________________________________________ 63
14.1 General__________________________________________________________________________________ 63
14.2 Organization and Staffing ___________________________________________________________________ 63
14.3 Delivery of Service _________________________________________________________________________ 64
14.4 Operating Room Record ____________________________________________________________________ 65
14.5 Post-surgical Anesthesia Care ________________________________________________________________ 65
14.6 Reporting and Documentation _______________________________________________________________ 65
15 Anesthesia Services_____________________________________________________________________________ 67
15.1 General__________________________________________________________________________________ 67
15.2 Rescue Capacity ___________________________________________________________________________ 68
15.3 Monitoring and Measuring Responsibility of Anesthesia Services ___________________________________ 69
15.4 Delivery of Services ________________________________________________________________________ 69
15.5 Organization and Staffing ___________________________________________________________________ 70
16 Emergency Services_____________________________________________________________________________ 72
16.1 General__________________________________________________________________________________ 72
16.2 Personnel ________________________________________________________________________________ 72
16.3 Emergency Services Not Provided_____________________________________________________________ 73
16.4 Off-campus Departments ___________________________________________________________________ 73
17 Obstetric Services ______________________________________________________________________________ 74
17.1 General__________________________________________________________________________________ 74
17.2 Obstetric Anesthesia Services ________________________________________________________________ 75
18 Radiologic and Nuclear Medicine Services __________________________________________________________ 76
18.1 General__________________________________________________________________________________ 76
18.2 Safety for Patients and Staff _________________________________________________________________ 76
18.3 Facilities _________________________________________________________________________________ 77
18.4 Order ___________________________________________________________________________________ 78
18.5 Personnel ________________________________________________________________________________ 78
18.6 Records__________________________________________________________________________________ 78
19 Psychiatric and Behavioral Services________________________________________________________________ 79
19.1 Medical Records___________________________________________________________________________ 79
19.2 Staffing and Facility Requirements ____________________________________________________________ 80
19.3 Social Services ____________________________________________________________________________ 81
20 Rehabilitation Services __________________________________________________________________________ 82
20.1 General__________________________________________________________________________________ 82
20.2 Organization and Control ___________________________________________________________________ 82
20.3 Rehabilitation Treatment Plan________________________________________________________________ 82
20.4 Rehabilitation Facilities _____________________________________________________________________ 83
21 Pharmaceutical Services _________________________________________________________________________ 84
21.1 General__________________________________________________________________________________ 84
21.2 Administration of Medications and Biologicals __________________________________________________ 84
21.3 Education, Monitoring and Measuring _________________________________________________________ 85
21.4 Policy and Procedure for Physician Orders______________________________________________________ 85
21.5 Medication Delivery and Schedule of Administration _____________________________________________ 86
21.6 Controlled and Non-controlled Medications Security _____________________________________________ 87
21.7 Medication Errors _________________________________________________________________________ 88
22 Infection Prevention and Control__________________________________________________________________ 90
22.1 General__________________________________________________________________________________ 90
22.2 Organization and Policies ___________________________________________________________________ 90
23 Medical Records _______________________________________________________________________________ 92
23.1 General__________________________________________________________________________________ 92
23.2 Organization and Staffing ___________________________________________________________________ 92
23.3 Medical Record Requirements _______________________________________________________________ 92
23.4 Identification of Authors ____________________________________________________________________ 93
23.5 Confidentiality ____________________________________________________________________________ 93
23.6 Content of Record _________________________________________________________________________ 93
24 Laboratory and Transfusion Management __________________________________________________________ 96
24.1 General__________________________________________________________________________________ 96
24.2 Adequacy of Services_______________________________________________________________________ 96
24.3 Blood Transfusion _________________________________________________________________________ 97
24.4 Blood Supply and Management ______________________________________________________________ 97
25 Pathology Services _____________________________________________________________________________ 98
25.1 General _________________________________________________________________________________ 98
25.2 Delivery of Services ________________________________________________________________________ 98
25.3 Reporting and Documentation _______________________________________________________________ 99
25.4 Autopsy _________________________________________________________________________________ 99
26 Organ, Tissue, and Eye Donation/Procurement _____________________________________________________ 100
26.1 General_________________________________________________________________________________ 100
Module III
Ancillary Services _____________________________________________________________________________ 103
27 Food and Dietetic Services ______________________________________________________________________ 105
27.1 General_________________________________________________________________________________ 105
27.2 Policy __________________________________________________________________________________ 105
27.3 Diets ___________________________________________________________________________________ 105
28 Physical Environment __________________________________________________________________________ 107
28.1 Facilities ________________________________________________________________________________ 107
28.2 Life and Fire Safety Process_________________________________________________________________ 107
28.3 Security Management Process ______________________________________________________________ 109
28.4 Emergency Management Process ____________________________________________________________ 109
28.5 Hazardous Materials (HAZMAT) Process_______________________________________________________ 110
28.6 Medical Equipment Process ________________________________________________________________ 111
28.7 Utility Systems Process ____________________________________________________________________ 112
29 Sterilization and Decontamination Services ________________________________________________________ 113
29.1 General_________________________________________________________________________________ 113
29.2 Selection of Medical Devices and Equipment___________________________________________________ 114
29.3 Storage, Segregation and Transport __________________________________________________________ 115
30 Information Security Management _______________________________________________________________ 116
30.1 General_________________________________________________________________________________ 116
30.2 Outsourcing _____________________________________________________________________________ 116
30.3 Equipment Security _______________________________________________________________________ 116
30.4 Access Control ___________________________________________________________________________ 117
30.5 Business Continuity Management____________________________________________________________ 117
COMPARATIVE TABLE
Version 6.0 to Version 5.0__________________________________________________________________________ 118
BIBLIOGRAPHY___________________________________________________________________________________ 124
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