Centers for Combined Medicare and Medicaid Services CMS

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Centers for Combined Medicare and Medicaid
Services (CMS)

• Appendix A Survey Protocol
• Regulations and Interpretive Guidelines

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Chris Cahill MS, BS, RN

• Infection Control Consultant
• California Department of Health Services
• Licensing and Certification Program

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Survey Protocol

• Survey 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

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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 - ?

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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 surveys

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Conditions of Participation

• 24 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)

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Conditions of Participation

• 482.11 Compliance with Federal, State and Local
  Laws
• 482.12 Governing Body
• 482.13 Patients Rights
• 482.21 Quality Assessment and Performance
  Improvement
• 482.22 Medical Staff
• 482.23 Nursing Services

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Conditions of Participation

• 482.24 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

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Conditions of Participation

• 482.43 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

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Sections of Regulation

• Tag number (Ahospitals, FSNF)
• Regulation number
• Regulatory language statement
• Standard (may be more than one for each
  regulation)
• Interpretive Guideline
• Survey protocol or procedure (sometimes)

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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

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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

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482.13 CoP Patients Rights

• Regulation Hospital must protect and promote
  each patients rights
• Standard The patient has a right to receive care
  in a safe setting
• IG Care delivered in an environment that is safe

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482.13 CoP Patients Rights

• IG Environment that a reasonable person
  considers safeFollow 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

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CoP Quality Assessment and Performance
Improvement (QAPI)

• Regulation The hospital must develop, implement
  and maintain an effective, ongoing, data-driven,
  QAPI program
• -The hospitals governing body must ensure that
  the program reflects the complexity of the
  hospitals organization and services-Must
  maintain and demonstrate evidence of QAPI program
  for review by CMS

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CoP Quality Assessment and Performance
Improvement (QAPI)

• Standard (a) Program Scope
• (a)(1) Must includeProgram shows measurable
  improvement in indicators for which there is
  evidence that it will improve health outcomes,
  and identify and reduce medical errors

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CoP Quality Assessment and Performance
Improvement (QAPI)

• Program Scope (a)(2)(cont)
• 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 DataCollect data to
  monitor effectiveness and safety of services and
  quality of care.

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CoP Quality Assessment and Performance
Improvement (QAPI)

• Standard (b)(1) Program DataIncorporate 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

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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

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CoP Quality Assessment and Performance
Improvement (QAPI)

• Standard (c)(2) Program Activities
  (cont)-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

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CoP Quality Assessment and Performance
Improvement (QAPI)

• Standard(c)(3) Program Activities (cont)-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

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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

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482.42 CoP Infection Control

• Regulation 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.

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482.42 CoP Infection Control

• IG -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)..

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482.42 CoP Infection Control

• IG (cont)
• -Active surveillance program
• -Measures for prevention, early detection,
  control, education, and investigation of
  infections
• -Evaluate the effectiveness of the program
• -Take corrective action

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482.42 CoP Infection Control

• IG (cont)-Implement of nationally recognized
  systems of infection control guidelinesCDC,
  OSHA, APIC
• -Policies that address-Definition of infections
  and communicable diseases (CD) -Measures to
  identify, investigate and report

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482.42 CoP Infection Control

• IG (cont)-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

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482.42 CoP Infection Control

• IG (cont)-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

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482.42 CoP Infection Control

• IG-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

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482.42 CoP Infection Control

• IG (cont)-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)

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482.42 CoP Infection Control

• IG (cont)-Reporting to local health
  department-Emergency preparedness-Program
  evaluation and revision
• Program is hospital-wide, includes all locations,
  campuses, departments and services

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482.42 CoP Infection Control

• Standard (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.

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482.42 CoP Infection Control

• The 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 PP developed and implemented

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482.42 CoP Infection Control

• Standard (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

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482.42 CoP Infection Control

• Standard (a)(1) (cont)
• IG System for identifying, investigating,
  reporting and preventing spread of infection and
  CD and outbreaks.

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482.42 CoP Infection Control

• Standard (a)(1) (cont) Cooperating
  with -Orientation and in-service education
  programs -Other departments and services in
  performance of quality assurance
  activities -With local health
  department Emergency preparedness

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482.42 CoP Infection Control

• Standard (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.

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482.42 CoP Infection Control

• Standard (a)(2) (cont)
• 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.

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482.42 CoP Infection Control

• (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

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482.42 CoP Infection Control

• (b) Standard Responsibilities of Chief Executive
  Officer, Medical Staff and Director of Nursing
  Services (cont)
• (2) Be responsible for the implementation of
  successful corrective action plans in affected
  problem areas

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482.42 CoP Infection Control

• IG 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. The plans should be evaluated for
  effectiveness and revised if needed and
  documentation should be maintained