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Accreditation & Regulatory Requirements for the Infection Prevention & Control Program Acute & Ambulatory Care Settings Russ Olmsted, MPH, CIC [email protected] Objectives Describe impact of value-based purchasing on awareness and focus on prevention of HAIs Describe at least one element of performance related to infection prevention accreditation requirements List at least one national patient safety goal that relates to infection prevention List at least one condition from CMS that applies to hospitals and ambulatory surgery centers Describe application of accreditation and regulatory requirements to healthcare facilities Platform for Performance Improvement The Vision of Health Care in the U.S. 2012 • Fragmented • Fee-for-service Volumedriven healthcare Cost VALUEdriven healthcare Quality • Connected • Bundled • Accountable Value Based PurchasingDefinition As part of the Affordable Care Act, congress has authorized the inpatient Value Based Purchasing Program, which provides a data reporting infrastructure for hospitals to help ensure quality patient outcomes http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/ hospital‐value‐based‐purchasing/index.html?redirect=/hospital‐value‐based‐purchasing Accessed on April 26, 2013 Crossing the Chasm: New Era of Accountability & Value-Based Care No facility is an “island” Acute Care Facility Home Care Outpatient/ Ambulatory Facility Tranquil Gardens Nursing Home Long Term Care Facility Making The Case for Jumping the Chasm: the portable patient! Interfacility sharing of patients, Orange County, California, 2005 Each hospital = unique color ; 29% of patients had > 2 admissions Of those with > 2 adms. 75% transferred between facilities Huang SS et al. Infect Cont Hosp Epidemiol 2010 The Portable Patient, continued. . 3 different phases of investigation of inter-facility trans. of carbapenemprod. K. pneumoniae 24 (60%) of 40 cases were linked to LTACH-A Won S Y et al. Clin Infect Dis. 2011;53:532-540 The Portable Patient, continued Microbial Highways: Networks of interfacility transmission of carbapenemaseprod. K. pneumoniae 4 adjacent counties, IN & IL 40 patients (11 [27.5%] Fatal infection) 24/60 (60%) cases assoc. with LTAC “A” Won SY, et al. Clin Infect Dis 2011 Cluster reached 14 Hosp., 2 LTAC, & 10 LTCFs. Case Study: George & C. difficile 1) Visits his primary care provider; receives Rx for antibiotic for LRI 2) Falls @ home and breaks his leg, admitted to “hospital A” acquires C. difficile 3) Transferred to inpatient rehab facility in hosp. A; develops acute, watery diarrhea + WBC incr + fever 4) Transferred back to progressive care unit in hospital A Rx. - oral vanco. 6) Too weak to return home….admitted to LTCF B CDC. Vital signs 2012: CDI External Drivers: Rise of Consumer Driven Legislation Action Plan to Prevent HAIs, June 2009 http://www.hhs.gov/ash/initiatives/hai/index.html Tier 1: Targets/Metrics – Acute Care Tier 2: Ambulatory Surgery Clinics, Dialysis Centers, Influenza vaccine for Healthcare Personnel Tier 3: Long Term Care American Recovery and Reinvestment Act (ARRA), 2009. Public Law 111-5 Wright D. HHS Roadmap to Elimination of HAIs http://www.hhs.gov/ash/initiatives/hai/actionplan/index.html Federal HAI Reporting To NHSN Under Inpt. Quality Reporting: Past/present & Future 2011 • CLABSI – Acute Care ICUs (Jan.) 2012 • • • • • CAUTI – Acute Care ICUs (except NICUs) (Jan.) CAUTI – LTCH, IRF, Cancer Hospitals (Oct) SSI – Colon Surgeries and Abdominal Hyst. – Acute Care (Jan) Dialysis Events – ESRD (Jan) CLABSI – LTCH, Cancer Hospitals (Oct) 2013 • • • • C. Diff LabID Events – Acute Care (Jan.) MRSA Bacteremia LabID Events – Acute Care (Jan.) HCP Influenza Vaccination – Acute Care (Jan.) HCP Influenza Vaccination – LTCH (Jan.) 2014 • HCP Influenza Vaccination – ASCs (Oct.) • SSI – Cancer Hospitals (Jan.) • HCP Influenza Vaccination – IRF (Oct.) 2015 • • • • CLABSI – Acute Care Med, Surg, Med/Surg Units (Jan.) CAUTI – Acute Care Med, Surg, Med/Surg Units (Jan.) MRSA Bacteremia LabID Events – LTCH (Jan.) C. Diff LabID Events – LTCH (Jan.) APIC. Federal HAI Reporting to NHSN resource update. www.apic.org 9/17/13 The Future of VBP Domains http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/ hospital‐value‐based‐purchasing/index.html?redirect=/hospital‐value‐based‐purchasing Accessed on April 26, 2013 2015 Clinical Process of Care Measures will Include: Patient Experience (HCAHPS) measures will stay the same http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/hospital‐value‐based‐purchasing/index.html? redirect=/hospital‐value‐based‐purchasing Accessed on April 26, 2013 2015 Outcome and Efficiency Measures: Outcome Measures AHRQ (PSI-90) Complication/patient safety for selected indicators (composite) CLABSI Central line-associated bloodstream infection, all locations – not just ICU CAUTI Catheter-associated urinary tract infection, all locations – not just ICU MRSA bacteremia Lab ID Methicillin-resistant S. aureus bacteremia using CDC’s National Healthcare Safety Network (NHSN), long term care hospital (LTCH) C. Diff Lab ID C. Difficile positive Lab. Test, NHSN, LTCH MORT-30-AMI Acute myocardial infarction 30-day mortality rate MORT-30-HF Heart Failure (HF) 30-day mortality rate MORT-30-PN Pneumonia (PN) 30-day mortality rate Efficiency Measures MSPB-1 Medicare spending per beneficary http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/hospital‐value‐based‐purchasing/index.ht ml?redirect=/hospital‐value‐based‐purchasing Accessed on April 26, 2013 Accreditation Agencies in U.S. Healthcare Facilities Founded by the American Osteopathic Association (AOA) Granted "Deeming Authority" to conduct accreditation surveys of acute care hospitals by the Centers for Medicare & Medicaid Services (CMS) 2009 Accreditation Requirements for Healthcare Facilities; More Details: http://www.hfap.org/ Accreditation Requirements in U.S. Healthcare Facilities Patient Safety Initiatives: 07.01.02 /19-Prevent central line-assoc. bloodstream infection 07.01.20 – Prevent Surgical Site Infections (SSIs) 07.01.21 Hand Hygiene Guidelines 07.01.02 Multidrug-resistant organism (MDRO) prevention 07.01.24 & 25; Influenza Vaccination – healthcare personnel 07.01.02 Care of the ventilated patient 07.01.03 Prevent catheter-associated UTI (CAUTI) Top cited condition level standards: 07.00.00 Infection Control CMS Condition of Participation: Infection Control. The 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. Accreditation Requirements Founded in 1951 by American College of Physicians, AHA, AMA, Canadian Medical Association, & American College of Surgeons Accreditation Programs for: Ambulatory, Behavioral Health Care, Critical Access Hospital, Disease-Specific Care, Home Care,Hospital, Lab, Long Term Care, Office-Based Surgery Granted "Deeming Authority" to conduct accreditation surveys by CMS http://www.jointcommission.org National Patient Safety Goals (NPSG), Hospital, 2012 NPSG.07.01.01: Comply with CDC or WHO Hand Hygiene Guidelines NPSG.07.03.01: Implement evidence-based practices to prevent health care–associated infections due to multidrugresistant organisms (MDROs) NPSG.07.04.01: Prevent central line–associated bloodstream infections (CLABSIs) NPSG.07.05.01: Preventing surgical site infections (SSIs). New NPSG 07.06.01; in full effect Jan. 2013: Preventing Catheter-associated UTIs (CAUTI) Accreditation Standards, 2012 IC.01.01.01:The [organization] identifies the individual(s) responsible for the infection prevention and control program Element(s) of Performance (EP): The hospital identifies the individual(s) with clinical authority over the infection prevention and control program. IC.01.02.01. Hospital leaders allocate needed resources for the infection prevention and control program. Information, resources, equipment & supplies Accreditation Standards, 2012 IC.01.03.01:The [organization] identifies risks for acquiring and transmitting infections EPs: Identify risks- acquiring and transmitting infections, based on: geographic location, community, and population served. Care, treatment, and services it provides. Analysis of surveillance activities and other infection control data. Review risks at least annually and whenever significant changes occur Prioritizes the identified risks Accreditation Standards, 2012 IC.01.04.01:Based on the identified risks, the hospital sets goals to minimize the possibility of transmitting infections EPs: The hospital's written infection prevention and control goals include the following: Addressing its prioritized risks. Limiting unprotected exposure to pathogens. Limiting the transmission of infections associated with: procedures use of medical equipment, devices, and supplies. Improving compliance with hand hygiene guidelines Accreditation Standards, 2012 IC.01.05.01:The [organization] has an infection prevention and control plan. Evidence-based national guidelines or, in the absence of such guidelines, expert consensus. The hospital’s infection prevention and control plan includes: a written description of the activities, including surveillance, etc. process to evaluate the infection prevention and control plan. The hospital describes, in writing, the process for investigating outbreaks of infectious disease. All hospital components and functions are integrated into infection prevention and control activities. Communicating responsibilities about prevention to independent practitioners, staff, visitors, patients, and families. Methods for reporting infection surveillance and control information to external organizations. Example of Annual Infection Prevention & Control Plan Site of Infection / focus Goal(s) Implementation Strategies Measurement Surgical Site Infections (SSI) prevention SSI SIR at or below 1.0 for applicable procedure groups. No razors Preop Abx timing SSI standardized infection ratio (SIR) Normothermia… Central LineAssociated Bloodstream Infections (CLABSI CLABSI at or below 1.0 CLABSI prevention bundle CHG cleansing… Analyze & Report monthly trend analysis of CLABSIs C. Difficile infection Rate of HA-CDI = 8.0/10,000 patient days Enhanced environmental disinfection Real time feedback Incidence of HACDI by inpatient unit Accreditation Standards, 2012 IC.01.06.01: The hospital prepares to respond to an influx of potentially infectious patients. Identify resources that can provide information about infections that could cause an influx of potentially infectious patients. Obtain current clinical and epidemiological information from its resources regarding new infections that could cause an influx of potentially infectious patients. Method for communicating critical information to licensed independent practitioners and staff about emerging infections that could cause an influx Describe, in writing, how it will respond to an influx of potentially infectious patients. Response plan for managing these patients over an extended period of time. See also, Emergency Management (EM) chapter; emergency operations plan, etc. Accreditation Standards, 2012 IC.02.01.01: The [organization] implements its infection prevention and control plan. Standard & transmission-based precautions Outbreak investigation Minimize risk of cross transmission from medical waste …communicate responsibilities for preventing and controlling infection to personnel, visitors, patients, and families, e.g. hand and respiratory hygiene practices Report findings from surveillance to appropriate personnel Transfer notification “infection requiring action”: Receiving organization, e.g. MDRO detected prior to discharge Referring organization, e.g. MDRO detected after admission Accreditation Standards, 2012 IC.02.02.01: The [organization] reduces the risk of infections associated with medical equipment, devices, and supplies. The hospital implements infection prevention and control activities when doing the following: Cleaning and disinfecting medical equipment, devices, and supplies. Sterilizing medical equipment, devices, and supplies. Disposing of medical equipment, devices, and supplies. Storing medical equipment, devices, and supplies. When reprocessing single-use devices, the hospital implements infection prevention and control activities that are consistent with regulatory and professional standards. The Case of the Unpackaged Laryngoscope Blade Blade = semicritical device; contact with mucous membrane The surveyor finding: unpackaged blades in a anesthesia cart drawer. Response Strategies; after cleaning: Handle = noncritical High level disinfection then package ea. blade in disposable, closable plastic bag …OR… Steam sterilize blades and then package each in closable, plastic bag…OR… Pre-packaged disposable blades – discard after each use Evid.-based guidelines; Prev. of HC assoc. Pneu., 2003 A. Sterilization or Disinfection and Maintenance of Equipment and Devices 1. a. Thoroughly clean all equipment and devices to be sterilized or disinfected (category Ia) 1. b. After disinfection, proceed with appropriate rinsing, drying, and packaging,… (category Ia) See also: Manufacturer’s Instr. For Use (IFU) Accreditation Standards, 2012 IC.02.03.01: The [organization] works to prevent the transmission of infectious disease among [patient]s, licensed independent practitioners, and staff. The hospital makes screening for exposure and/or immunity to infectious disease available to licensed independent practitioners (LIPs) and staff who may come in contact with infections at the workplace. Referral mechanisms for LIPs or staff who have, or are suspected of having, an infectious disease that puts others at risk that provides them with or refers them for assessment, testing, immunization, prophylaxis/treatment, or counseling. Provide or refer for assessment, testing, immunization, prophylaxis/treatment, or counseling of personnel after occupational exposure or, if applicable, for patients exposed to infectious diseases. Accreditation Standards, 2012 IC.02.04.01: The [organization] offers vaccination against influenza to licensed independent practitioners and staff.The hospital makes screening for exposure and/or immunity to infectious disease available to licensed independent practitioners (LIPs) and staff who may come in contact with infections at the workplace. Annual influenza vaccination program that is offered to LIPs and staff. Education for LIPs and staff about: influenza vaccine; non-vaccine control and prevention measures; and the diagnosis, transmission, and impact of influenza. Provide influenza vaccination - make accessible Annual evaluation and increase vaccination rates Accreditation Standards, 2012 IC.03.01.01: The [organization] evaluates the effectiveness of its infection prevention and control plan. Evaluate the effectiveness of its infection prevention and control plan annually and whenever risks significantly change. The evaluation includes: infection prevention and control plan's prioritized risks. Goals Implementation of the infection prevention and control plan’s activities. Findings from the evaluation are communicated at least annually to the individuals or interdisciplinary group that manages the patient safety program. Use findings of its evaluation when revising the plan. Additional Accreditation AgenciesDet Norske Veritas (DNV) Healthcare, Inc http://www.dnv.com/industry/healthcare/ Accreditation Association for Ambulatory Health Care www.aaahc.org American Association for Accreditation of Ambulatory Surgery Facilities www.aaaasf.org CMS Conditions of Participation (CoP) and Conditions for Coverage (CfC) http://www.cms.gov/Regulations-andGuidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs /06_Hospitals.asp OR, closer to home: http://www.michigan. gov/lara/ Follow links to Bureau of Health Systems then hospitals, home Health, etc. Regulatory Requirements for IPC Program § 482.42 Condition of participation: Infection control. • The 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. Regulatory Requirements for IPC Program Revisions, 5/16/2012§ 482.42 Condition of participation: Infection control. a) Standard: Organization and policies. A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases. The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. §482.42 Condition of Participation: Infection Control; revisions, 5/16/12 Standards (A748-A756) • System developed by IC officer for identifying,reporting, investigating, and controlling infections and communicable diseases CEO, medical staff, and nursing director ensure QAPI* program address problems identified in infection prevention and control program Quality assessment and performance improvement (QAPI) (1) Ensure that the hospital-wide quality assessment and performance improvement (QAPI) program and training programs address problems identified by the infection control officer or officers; and § 482.41 Condition of participation: Physical environment The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. §482.42 Interpretive Guidelines -State Operations Manual, 12-22-2011 Infection Control Officer (ICO) incl. hospital epidemiologists (HEs) or ―infection control professionals (ICPs). (APIC & MSIPC = Infection Preventionist) a person(s) whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control. Designated in writing Qualified through education, training, experience, or certification (such as that offered by the Certification Board of Infection Control and Epidemiology Inc. (CBIC) – That’s why you are here! Number of IPs not specified but needs to be adequate for the IPC program New IP Competency Model, May 2012 issue of AJIC – tab 2 Supporting Principles • Competency is self defined • Competency is self assessed • Certification is necessary • Education supports all levels and aspects of competency CIC Matters: Pogorzelska M, et al AJIC 2012 or… CIC is more effective against MRSA than vancomycin, linezolid, & quinupristin/ dalfoprinstin combined! “Having a director with CIC was an independent predictor of lower MRSA BSI rates” See also the following studies that all found correlation between CIC and implementation of evidence based practices: • • • Krein SL, Hofer TP, Kowalski CP, et al. Use of central venous catheter-related bloodstream infection practices by US hospitals. Mayo Clin Proc. 2007;82(6):672-678. Krein SL, Kowalski CP, Damschroder L, et al. Preventing ventilator-associated pneumonia in the United States: A multicenter mixed-methods study. Infect Control Hosp Epidemiol 2008; 29:933-940 Saint S, Kowalski CP, Kaufman SR, et al. Preventing hospital-acquired urinary tract infection in the United States: A national study. Clin Infect Dis 2008; 46:243–50. Socio-Adaptive Skills : New Horizons for IPs in the 21st Century; Sanjay Saint, MD – U of M Patient Safety Enhancement Program , SHEA Annual Conference, 2011 Future training should ideally include: • Implementation science • Leadership and management • Communication skills • Teamwork • Negotiation • Human factors engineering • Organizational behavior and group psychology Will help us better deal with the reality of preventing infection in real-world settings CoP: Environment of Care A-0726 §482.41(c)(4) - There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas “… Temperature, humidity and airflow in anesthetizing locations must be maintained within acceptable standards to inhibit microbial growth, reduce risk of infection, control odor, and promote patient comfort ” Tools for Survey Readiness from CMS: Hospital Ambulatory Surgical Centers Growth in Ambulatory Care Shift in healthcare delivery from acute care settings to ambulatory care, long term care and free standing specialty care sites Approximately 1.2 billion outpatient visits / year Number of Dialysis Centers Infection control oversight often lacking 2008: 4,950 (72% increase since 1996) Number of Ambulatory Surgical Centers 2008: 5,100 (240% increase since 1996) 2007: More that 6 million surgeries performed in ASCs Increasing numbers of surgical procedures are moving from the inpatient to the outpatient setting Procedures (millions) Outpatient Settings Inpatient 1 9 8 1 Source: Avalere Health analysis of Verispan’s Diagnostic Imaging Center Profiling Solution, 2004, and American Hospital Association Annual Survey data for community hospitals, 1981-2004. *2005 values are estimates. 2005 Why Are Ambulatory Surgical Centers (ASCs) & Other Ambulatory Care Settings Under Scrutiny? Surgical Tech Sparks Hep C Outbreak Friday, July 17, 2009 State Health Department Posts Case Numbers Associated with Hepatitis C Investigation Nevada Field Investigation of Hepatitis C Transmission in Ambulatory Surgery Centers • Discovered reuse of syringes and single dose vials • Resulted in massive patient notification: risks of bloodborne viral infections due to unsafe injection practices HI AK DC ASC Conditions for Coverage (CfC) §416.51 Condition: Infection Control “The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases.” – effective 05/18/2009 Standards (Q241-Q245) Sanitary Environment Ongoing IC program following IC guidelines Qualified professional directs IC program IC program an integral part of QAPI IC program has a plan of action for combating infections and communicable diseases Sanitary Environment Needs Also Apply to ASC 19% of facilities did not appropriately clean high-touch surfaces in patient care areas Schaefer MK, et al. JAMA. 2010;303:2273-2279 Tools for Survey Readiness from CMS: ASC