ࡱ> zakW7{y3T( a( /0/ 00DArialngsRoH_b _bbv 0b( 0"DVerdanasRoH_b _bbv 0b( 0" DTimes New Roman _bbv 0b( 00DWingdingsRoman _bbv 0b( 0 a .  @n?" dd@  @@`` zV  ()  21         !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUV/X$Nr$kW7{y3TiN 0AA@8wʚ;ʚ;g4HdHdv 0bNppp@ <4dddd` 0b| _b <4!d!d4b 0bb80___PPT10 ? %O =jT9Centers for Combined Medicare and Medicaid Services (CMS)::$Appendix A  Survey Protocol Regulations and Interpretive GuidelinesChris Cahill MS, BS, RNjInfection Control Consultant California Department of Health Services Licensing and Certification Program  kZiSurvey ProtocolSurvey authority 42 CFR Part 488 Subpart A Refusal of access  OIG may exclude hospital from participation in all federal programs Survey generally performed by State agency surveyors, CMS surveyors may perform survey Types of Surveys JCAHO/CALS  Title 22, announced Licensing (non-JCAHO)  Title 22 some also use the federal regulations, unannounced Complaint  generally T 22, unannounced Complaint  also can be federal (CMS) survey, unannounced Local paper - ? Z$Validation Surveys Determined by CMS%%"Random announced post JCAHO Random unannounced Complaint State Licensing T22 convert to validation survey (need CMS approval) State paid by CMS for all federal surveys but not state licensing surveysZ Conditions of Participation24 Conditions of Participation (CoP) We do not survey Provision for Emergency Services by Non-Participating Hospitals or Utilization review Tag numbers  each section and subsection has Tag number for electronic data entry and retrieval Each CoP has regulation number Each Standard has a regulation number and letter (a)(1), (a)(2) OPOConditions of Participation482.11 Compliance with Federal, State and Local Laws 482.12 Governing Body 482.13 Patient s Rights 482.21 Quality Assessment and Performance Improvement 482.22 Medical Staff 482.23 Nursing Services Conditions of Participation482.24 Medical Records Services 482.25 Pharmaceutical Services 482.26 Radiological Services 482.27 Laboratory Services 482.28 Food and Dietetic Services 482.29 Utilization Review 482.41 Physical Environment 482.42 Infection Control ZConditions of Participation482.43 Discharge Planning 482.45 Organ, Tissue, Eye Procurement 482.51 Surgical Services 482.52 Anesthesia Services 482.53 Nuclear Medicine Services 482.54 Outpatient Services 482.55 Emergency Services 482.56 Rehabilitation Services 482.57 Respiratory Services P Sections of RegulationTag number (A=hospitals, F=SNF) Regulation number Regulatory language statement Standard (may be more than one for each regulation) Interpretive Guideline Survey protocol or procedure (sometimes) Interpretive Guidelines (IG)Written for each regulation Interpret and clarify CoP Contain authoritative interpretations of statutory and regulatory requirements and are used to determine compliance with specific regulation Do not impose new requirements  Regulation 482.11"CoP: Compliance with applicable state and federal regulations Regulation: The hospital must be in compliance with all applicable Federal laws related to health and safety of patients -OSHA Bloodborne Pathogens -OSHA TB Control 0  482.13 CoP: Patients Rights"vRegulation: Hospital must protect and promote each patient s rights Standard: The patient has a right to receive care in a safe setting IG: Care delivered in an environment that is safe   482.13 CoP: Patients RightsIG: Environment that a reasonable person considers safe Follow current standards of practice for environmental safety and infection control Survey Procedure: Review, analyze patient and staff incident and accident reports, review infection control minutes Z :CoP: Quality Assessment and Performance Improvement (QAPI);;"tRegulation: The hospital must develop, implement and maintain an effective, ongoing, data-driven, QAPI program -The hospital s governing body must ensure that the program reflects the complexity of the hospital s organization and services& -Must maintain and demonstrate evidence of QAPI program for review by CMS o; :CoP: Quality Assessment and Performance Improvement (QAPI);;"Standard (a): Program Scope (a)(1) Must include: Program shows measurable improvement in indicators for which there is evidence that it will improve health outcomes, and identify and reduce medical errors  :CoP: Quality Assessment and Performance Improvement (QAPI);;"tProgram Scope (a)(2)(con t) Must measure, analyze and track quality indicators including adverse patient events, other aspects of performance that assess processes of care, hospital service and operations Standard (b): Program Data Collect data to monitor effectiveness and safety of services and quality of care& .;;.*:CoP: Quality Assessment and Performance Improvement (QAPI);;"'Standard (b)(1): Program Data Incorporate quality indicator data.. Use data to (i) Monitor effectiveness and safety of services and quality of care (ii) identify opportunities for improvement and changes leading to improvement (b)(3) The frequency and detail of data specified by governing body E(:CoP: Quality Assessment and Performance Improvement (QAPI);;"Standard (c) Program Activities (1)The hospital must set priorities for its performance improvement activities that (ii) Focus on high-risk, high-volume or problem-prone areas; (ii) Consider incidence, prevalence and severity of problems; and (iii) Affect health outcomes and quality of care (iv) affect patient safety BB:CoP: Quality Assessment and Performance Improvement (QAPI);;" Standard (c)(2) Program Activities (con t) -Performance improvement activities must track medical errors and adverse patient events; -Analyze their causes -Implement preventive action and mechanisms that include feedback and learning throughout the hospital &:CoP: Quality Assessment and Performance Improvement (QAPI);;"VStandard(c)(3): Program Activities (con t) -The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and, track performance to ensure that improvements are sustained Standard (d): Performance Improvement Projects& ,,$& 482.24 CoP: Medical Records Services''"Standard (c): Content of Record (c)(2)(iv)Documentation of complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia 482.42 CoP: Infection ControlRegulation: Hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control and investigation of infections and communicable diseases.482.42 CoP: Infection ControlIG: -Develop, implement and maintain program for prevention, control and investigation of infections (includes, but not limited to, nosocomial infections) & of patients (includes but is not limited to patient care staff)..482.42 CoP: Infection ControlIG: (con t) -Active surveillance program -Measures for prevention, early detection, control, education, and investigation of infections& -Evaluate the effectiveness of the program -Take corrective action 482.42 CoP: Infection ControlIG: (con t) -Implement of nationally recognized systems of infection control guidelines CDC, OSHA, APIC -Policies that address -Definition of infections and communicable diseases (CD) -Measures to identify, investigate and report "hZZ482.42 CoP: Infection ControlIG: (con t) -Identify, investigate, control outpatient post-op infections -Staff at risk for infection -Obtain reports on inpatients, outpatient and HCW (including contract staff) -Prevent infections caused by antibiotic-resistant microorganisms 482.42 CoP: Infection ControlIG: (con t) -Prevent device related infections -Prevent CD outbreaks (TB, SARS, BBP, foodborne, MRSA, VRE,etc) -Safe environment -Isolation -Standard Precautions -Education of family, caregivers -Evaluate aseptic technique practices Z>K !482.42 CoP: Infection ControlIG: -Hand washing, respiratory protection asepsis, sterilization, disinfection, food sanitation, housekeeping, fabric care, liquid and solid waste disposal, needle disposal, separation of clean and dirty -Authority and indications for culturing patients"482.42 CoP: Infection ControlIG (con t) -Disinfectants, antiseptics and germicides used according to manufacturer instructions -Orientation of new personnel to program -Screening HCW exposed to non-treated CD -Work related employee health (when they can work or return to work) Z#482.42 CoP: Infection Control~IG (con t) -Reporting to local health department -Emergency preparedness -Program evaluation and revision Program is hospital-wide, includes all locations, campuses, departments and services $ 482.42 CoP: Infection ControlStandard (a): Organization and Policies Regulation: A person or persons must be designated and infection control officer or officers to develop and implement policies governing control of infections and CD. IG: Designate in writing an individual or group of individuals, qualified through education, training, experience and certification or licensure, as infection control officer or officers. %!482.42 CoP: Infection Control0The infection control officer or officers must develop and implement policies governing control of infections and CD. Survey Procedure: -Interview -Verify and evaluate integration of program into QAPI program -Verify designated officer -Review officer personnel file -Verify P&P developed and implemented11&"482.42 CoP: Infection ControlStandard (a)(1): -Must develop a system for identifying, reporting, investigating and controlling infections and CD in patients and personnel, IG: Responsible for: -Implementing policies governing asepsis, sterilization and infection control .ZZdZ'#482.42 CoP: Infection ControlStandard (a)(1) (con t) IG: System for identifying, investigating, reporting and preventing spread of infection and CD and outbreaks. s($482.42 CoP: Infection ControlStandard (a)(1) (con t) Cooperating with: -Orientation and in-service education programs -Other departments and services in performance of quality assurance activities -With local health department Emergency preparedness Z)%482.42 CoP: Infection ControlStandard (a)(2) The infection control officer or officers must maintain a log of incidents related to infections and CD. IG: Maintain a log of all incidents related to infections and CD, including those identified through employee health services..3<*&482.42 CoP: Infection ControlStandard (a)(2) (con t) IG: The log is not limited only to nosocomial infections. All incidents of infections and CD must be included in the log. The log documents infections and CD of patients and all staff. This would include incidents of post-operative infections in inpatients who are discharged soon after surgery or outpatients who receive outpatient surgery. rZr\+'482.42 CoP: Infection Controlf(b) Standard (b): Responsibilities of Chief Executive Officer, Medical Staff and Director of Nursing Services Regulation: The chief executive officer, the medical staff, and the director of nursing services must: (1) Ensure that the hospital-wide quality assurance plan and training programs address problems identified by the infection control officer, and gg,(482.42 CoP: Infection Control(b) Standard: Responsibilities of Chief Executive Officer, Medical Staff and Director of Nursing Services (con t) (2) Be responsible for the implementation of successful corrective action plans in affected problem areas km-)482.42 CoP: Infection ControlIG:& Must assure that the hospital-wide QAPI program and staff in-service training programs address problems identified through the infection control program & Must be responsible for implementing corrective action plans to address infection control related problems. 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