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SAFER, SMARTER, GREENERNATIONALINTEGRATEDACCREDITATION FORHEALTHCAREORGANIZATIONS (NIAHO ) Accreditation Requirements,Interpretive Guidelines and Surveyor Guidance ‐ Revision 18DNV GL Healthcare400 Techne Center Drive, Suite 100Milford, OH 45150Phone 513‐947‐8343 Fax 513‐947‐1250 Copyright 2005‐2018 DNV GL Healthcare USA, Inc.All Rights Reserved. No claim to U.S. Government work.
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018TABLE OF CONTENTSGLOSSARY .viiiQUALITY MANAGEMENT SYSTEM (QM) . 10QM.1 QUALITY MANAGEMENT SYSTEM. 10QM.2 ISO 9001 QUALITY MANAGEMENT SYSTEM . 10QM.3 QUALITY OUTLINE/PLAN. 11QM.4 MANAGEMENT REPRESENTATIVE . 12QM.5 DOCUMENTATION AND MANAGEMENT REVIEWS . 12QM.6 SYSTEM REQUIREMENTS . 12QM.7 MEASUREMENT, MONITORING, ANALYSIS. 13QM.8 PATIENT SAFETY SYSTEM . 14GOVERNING BODY (GB) . 16GB.1 LEGAL RESPONSIBILITY . 16GB.2 INSTITUTIONAL PLAN AND BUDGET . 16GB.3 CONTRACTED SERVICES . 17CHIEF EXECUTIVE OFFICER (CE) . 19CE.1 QUALIFICATIONS . 19CE.2 RESPONSIBILITIES . 19MEDICAL STAFF (MS). 20MS.1 ORGANIZED MEDICAL STAFF . 20MS.2 ELIGIBILITY . 20MS.3 ACCOUNTABILITY . 20MS.4 RESPONSIBILITY . 21MS.5 EXECUTIVE COMMITTEE . 23MS.6 MEDICAL STAFF PARTICIPATION. 23MS.7 MEDICAL STAFF BYLAWS . 24MS.8 APPOINTMENT . 25MS.9 PERFORMANCE DATA . 25MS.10 CONTINUING EDUCATION . 26MS.11 GOVERNING BODY ROLE. 26MS.12 CLINICAL PRIVILEGES . 27MS.13 TEMPORARY CLINICAL PRIVILEGES . 28MS.14 CORRECTIVE OR REHABILITATION ACTION . 29MS.15 ADMISSION REQUIREMENTS . 30MS.16 MEDICAL RECORD MAINTENANCE . 31MS.17 HISTORY AND PHYSICAL. 31MS.18 CONSULTATION . 33MS.19 AUTOPSY . 34MS.20 TELEMEDICINE . 34NURSING SERVICES (NS) . 36NS.1 NURSING SERVICE . 36NS.2 NURSE EXECUTIVE . 38NS.3 ASSESSMENT AND PLAN OF CARE . 39STAFFING MANAGEMENT (SM) . 42SM.1 LICENSURE OR CERTIFICATION . 42SM.2 PROFESSIONAL SCOPE . 42SM.3 DEPARTMENT SCOPE OF SERVICE . 42SM.4 DETERMINING AND MODIFYING STAFFING . 43SM.5 JOB DESCRIPTION . 43SM.6 ORIENTATION . 43SM.7 STAFF EVALUATIONS . 44MEDICATION MANAGEMENT (MM). 47MM.1 MANAGEMENT PRACTICES . 47MM.2 FORMULARY . 57MM.3 SCHEDULED DRUGS . 58MM.4 MEDICATION ORDERS . 59MM.5 REVIEW OF MEDICATION ORDERS . 60MM.6 OVERSIGHT GROUP . 63MM.7 AVAILABLE INFORMATION . 64SURGICAL SERVICES (SS) . 65SS.1 ORGANIZATION . 65SS.2 STAFFING AND SUPERVISION . 67Page iii of 228
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018SS.3 PRACTITIONER PRIVILEGES . 68SS.4 HISTORY AND PHYSICAL . 69SS.5 AVAILABLE EQUIPMENT . 71SS.6 OPERATING ROOM REGISTER . 72SS.7 POST-OPERATIVE CARE . 73SS.8 OPERATIVE REPORT . 74ANESTHESIA SERVICES (AS) . 77AS.1 ORGANIZATION . 77AS.2 ADMINISTRATION . 80AS.3 POLICIES AND PROCEDURES . 83LABORATORY SERVICES (LS) . 87LS.1 ORGANIZATION . 87LS.2 POTENTIALLY INFECTIOUS BLOOD AND PRODUCTS . 87LS.3 PATIENT NOTIFICATION . 90LS.4 GENERAL BLOOD SAFETY . 92RESPIRATORY CARE SERVICES (RC) . 94RC.1 ORGANIZATION . 94RC.2 ORDERS FOR TREATMENT AND INTERVENTIONS . 94RC.3 POLICIES OR PROTOCOLS . 95RC.4 TESTS OUTSIDE THE LABORATORY . 95MEDICAL IMAGING (MI) . 97MI.1 ORGANIZATION . 97MI.2 RADIATION PROTECTION . 97MI.3 EQUIPMENT . 98MI.4 ORDER . 99MI.5 SUPERVISION . 99MI.6 STAFF. 100MI.7 RECORDS. 100MI.8 INTERPRETATION AND RECORDS . 100NUCLEAR MEDICINE SERVICES (NM) . 102NM.1 ORGANIZATION . 102NM.2 RADIOACTIVE MATERIALS . 102NM.3 EQUIPMENT AND SUPPLIES . 103NM.4 INTERPRETATION . 104REHABILITATION SERVICES (RS) . 105RS.1 ORGANIZATION . 105RS.2 MANAGEMENT AND SUPPORT . 105RS.3 TREATMENT PLAN/ORDERS . 106EMERGENCY DEPARTMENT (ED) . 107ED.1 ORGANIZATION . 107ED.2 STAFFING . 107ED.3 EMERGENCY SERVICES NOT PROVIDED . 108ED.4 OFF-CAMPUS DEPARTMENTS . 109OUTPATIENT SERVICES (OS) . 110OS.1 ORGANIZATION. 110OS.2 STAFFING . 110OS.3 SCOPE OF SERVICE . 110OS.4 ORDERS . 111DIETARY SERVICES (DS) . 113DS.1 ORGANIZATION . 113DS.2 SERVICES AND DIETS . 114DS.3 DIET MANUAL . 115PATIENT RIGHTS (PR) . 117PR.1 NONDISCRIMINATION . 117PR.2 SPECIFIC RIGHTS . 117PR.3 ADVANCE DIRECTIVE . 121PR.4 LANGUAGE AND COMMUNICATION . 123PR.5 INFORMED CONSENT . 123PR.6 GRIEVANCE PROCEDURE . 124PR.7 RESTRAINT OR SECLUSION . 126PR.8 RESTRAINT OR SECLUSION: STAFF TRAINING REQUIREMENTS. 138PR.9 RESTRAINT OR SECLUSION: REPORT OF DEATH . 140INFECTION PREVENTION AND CONTROL (IC) . 143Page iv of 228
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018IC.1 INFECTION PREVENTION and CONTROL SYSTEM . 143MEDICAL RECORDS SERVICE (MR) . 149MR.1 ORGANIZATION . 149MR.2 COMPLETE MEDICAL RECORD. 149MR.3 RETENTION . 150MR.4 CONFIDENTIALITY . 150MR.5 RECORD CONTENT . 151MR.6 IDENTIFICATION OF AUTHORS . 153MR.7 REQUIRED DOCUMENTATION . 154DISCHARGE PLANNING (DC) . 157DC.1 WRITTEN POLICIES . 157DC.2 DISCHARGE PLANNING EVALUATION . 158DC.3 PLAN IMPLEMENTATION. 159DC.4 EVALUATION . 160UTILIZATION REVIEW (UR) . 162UR.1 DOCUMENTED PLAN . 162UR.2 SAMPLING . 163UR.3 MEDICAL NECESSITY DETERMINATION . 163UR.4 EXTENDED STAY REVIEW. 164PHYSICAL ENVIRONMENT (PE) . 165PE.1 FACILITY . 165PE.2 LIFE SAFETY MANAGEMENT SYSTEM . 175PE.3 SAFETY MANAGEMENT SYSTEM . 178PE.4 SECURITY MANAGEMENT SYSTEM. 179PE.5 HAZARDOUS MATERIAL (HAZMAT) MANAGEMENT SYSTEM . 181PE.6 EMERGENCY MANAGEMENT SYSTEM . 182PE.7 MEDICAL EQUIPMENT MANAGEMENT SYSTEM. 186PE.8 UTILITY MANAGEMENT SYSTEM . 193ORGAN, TISSUE AND EYE PROCUREMENT (TO) . 197TO.1 PROCESS . 197TO.2 ORGAN PROCUREMENT ORGANIZATION (OPO) WRITTEN AGREEMENT. 197TO.3 ALTERNATIVE AGREEMENT . 199TO.4 RESPECT FOR PATIENT RIGHTS . 199TO.5 DOCUMENTATION . 200TO.6 ORGAN TRANSPLANTATION . 200TO.7 TRANSPLANT CANDIDATES . 200SWING BEDS (SB) . 202SB.1 FACILTY ELIGIBILITY . 202ADMISSION, TRANSFER AND DISCHARGE (TD) . 203TD.1 TRANSFER AND DISCHARGE REQUIREMENTS. 203TD.2 DOCUMENTATION . 204TD.3 NOTIFICATION . 204TD.4 ORIENTATION FOR TRANSFER OR DISCHARGE. 205TD.5 CHANGE OF ROOM IN COMPOSITE DISTINCT PART . 206TD.6 DISCHARGE SUMMARY . 206PLAN OF CARE (PC) . 207PC.1 ASSESSMENT . 207PC.2 CARE PLAN. 208RESIDENTS RIGHTS (RR) . 210RR.1 EXERCISE OF RIGHTS . 210RR.2 NOTICE OF RIGHTS AND SERVICES . 210RR.3 HEALTH CARE DECISIONS . 212RR.4 ADVANCE DIRECTIVES. 212RR.5 MEDICAID BENEFITS . 213RR.6 PERSONAL PRIVACY AND CONFIDENTIALITY . 213RR.7 RESTRAINTS . 215RR.8 FREEDOM FROM ABUSE, NEGLECT, AND EXPLOITATION . 215RR.9 WORK . 218FACILITY SERVICES (FS) . 220FS.1 PATIENT ACTIVITIES . 220FS.2 SOCIAL SERVICES . 221FS.3 DENTAL SERVICES . 222FS.4 SPECIALIZED REHABILITATIVE SERVICES . 223Page v of 228
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018RESIDENT NUTRITION (RN) . 227RN.1 NUTRITIONAL STATUS. 227Page vi of 228
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018Use of NIAHO Accreditation Requirements, Interpretive Guidelines and Surveyor GuidanceEffective DateNIAHO Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance, Revision 18Effective Date: March 5, 2018.Supersedes NIAHO Revision 16 and all prior revisions. (Revision numbers now align with year of publication)National Professional Organizations- Standards of PracticeStandards of practice of the national professional organizations referenced in these NIAHO AccreditationRequirements, Interpretive Guidelines and Surveyor Guidance (NIAHO ) document are consultative and considered inthe accreditation decision.Federal Laws, Rules and RegulationsThe most current version of Federal law and the CFR referenced in this NIAHO document are incorporated herein byreference and constitute NIAHO accreditation requirements.This NIAHO document is based upon the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation42 CFR Section 482 and State Operations Manual Regulations and Interpretive Guidelines for Hospitals. TheseInterpretive Guidelines also are periodically updated based on notices distributed from CMS. Hospitals participating inthe Medicare and Medicaid program are expected to comply with current Conditions of Participation (CoP). When newor revised requirements are published, hospitals are expected to demonstrate compliance in a time frame consistentwith the effective date published by CMS in the Federal Register.Life Safety Code The Life Safety Code of the National Fire Protection Association referenced in this NIAHO document is incorporatedherein by reference and constitute NIAHO accreditation requirements.Page vii of 228
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018GLOSSARYAANAAmerican Association of Nurse AnesthetistsACSAmerican College of SurgeonsACIPCDC’s Advisory Committee on Immunization PracticesAOAAmerican Osteopathic AssociationAMAAmerican Medical AssociationAORNAssociation of perioperative Registered NursesAPICAssociation of Professionals in Infection Control and EpidemiologyAPPAdvanced Practice ProviderASAAmerican Society of AnesthesiologistsASHPAmerican Society of Health-System PharmacistsCDCCenters for Disease Control and PreventionCEOChief Executive OfficerCFRCode of Federal RegulationsCMSCenters for Medicare and Medicaid ServicesCoPCMS Conditions of Participation for Hospitals 42 C.F.R Section 482CRNACertified Registered Nurse AnesthetistDEADrug Enforcement Administration Federal Narcotics Registration CertificateDOTUnited States Department of TransportationFDAFood and Drug AdministrationHAIHealthcare Associated InfectionHHAHome Health AgencyHICPACCDC’s Healthcare Infection Control Practices Advisory CommitteeHVACHeating Ventilating and Air ConditioningISMPInstitute for Safe Medication PracticesISOInternational Organization of StandardizationLPNLicensed Practical NurseLVNLicensed Vocational NurseLSCLife Safety Code of the National Fire Protection AssociationMHAUSMalignant Hyperthermia Association of the United StatesNFPANational Fire Protection AssociationPage viii of 228
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018NIAHONational Integrated Accreditation for Healthcare OrganizationsNPDBNational Practitioner Data BankOIGOffice of Inspector General, Department of Health and Human ServicesOSHAOccupational Health and Safety AdministrationPRN (prn)Pro re nata, as the occasion arises, when necessaryQIOQuality Improvement OrganizationQMSQuality Management SystemQLPQualified Licensed PractitionerRNRegistered NurseSecretarySecretary of the Department of Health and Human ServicesSGNASociety of Gastroenterology Nurses and AssociatesSHEASociety for Healthcare Epidemiology of AmericaSMDASafe Medical Devices Act of 1990SNFSkilled Nursing FacilitySOPStandard Operating ProcedureSRStandard Requirement (accreditation requirement)Page ix of 228
NIAHOAccreditation Requirements, Interpretive Guidelines and Surveyor GuidanceRevision 18, 02-05-2018QUALITY MANAGEMENT SYSTEM (QM)QM.1 QUALITY MANAGEMENT SYSTEMThe governing body (or organized group or individual who assumes full legal authority and responsibility foroperations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuringthat the organization implements and maintains an effective quality management system. This quality managementsystem shall ensure that corrective and preventive actions taken by the organization are implemented, measuredand monitored.In addition to any other Quality Management System standard, the organization is required to comply with QM.1 atall times as a part of its Quality Management System. Until the organization achieves ISO 9001 Compliance/Certification, the organization shall follow at a minimum the ISO 9001 methodology specified in QM.2, SR.3.SR.1The organization must develop, implement, and maintain an ongoing system for managing qualityand patient safety.SR.1aAs a part of the QMS for addressing performance improvement and patient safety, theorganization must select projects or similar activities that focus attention on variousprocesses, functions and areas of the organization.SR.1a (1)The number and scope of these projects or similar activities will be conductedannually and be proportional to the scope and complexity of the organization’soperations and services offered.SR.1a (2)These projects or similar activities will be documented to include the rationale forselection and measurable progress achieved.SR.1a (3)If the organization participates in a Quality Improvement Organization (QIO)cooperative project, the organization must demonstrate
NIAHO National Integrated Accreditation for Healthcare Organizations . NPDB National Practitioner Data Bank . OIG Office of Inspector General, Department of Health and Human Services . OSHA Occupational Health and Safety Administration . PRN (prn) Pro re nata, as the occasion arises, when necessary
