HHS Action Plan to Prevent Healthcare-Associated Infections AMBULATORY

HHS Action Plan to Prevent Healthcare-Associated Infections: AMBULATORY SURGICAL CENTERS Progress Toward Eliminating Healthcare-Associated Infections Meeting September 24, 2010 Arlington, VA

I. INTRODUCTION q While initial HHA Action Plan focused on acute care, inpatien settings, the Steering Committee saw need to address HAI prevention more broadly q Ambulatory surgical centers (ASCs) were selected as a focus area for Tier 2 of the Action Plan q HHS interagency workgroup was formed § § q Centers for Medicare and Medicaid Services (CMS) Centers for Disease Control and Prevention (CDC) Agency for Healthcare Research and Quality (AHRQ) Indian Health Service (IHS) Draft Action Plan: update on progress made, remaining gap and recommendations for next steps

II. BACKGROUND q q ASCS are defined by CMS as distinct entities that exclusive provide surgical services to patients who do not require hospitalization and are not expected to need to stay in a surgical facility longer than 24 hours Currently, >5, 300 U. S. Medicare-certified ASCs § 54% increase since 2001 q 2007: over 6 million procedures performed in ASCs and paid for by Medicare at a cost of nearly $3 billion § Wide variety of procedures including endoscopy, injections to treat chronic pain, and dental surgery § Facilities are also heterogeneous re size, staffing, ownership type, chain or hospital affiliation , electronic health records

II. 1. Oversight of Medicare-Certified ASCs q ASCs are surveyed to measure compliance with Conditions f Coverage (Cf. Cs) § State Survey Agencies (SSA) § Accrediting Organization (AO) deemed by CMS • The Joint Commission (TJC) • Accreditation Association for Ambulatory Health Care (AAAHC) • American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) • American Osteopathic Association (AOA) q A minority (~20 -25%) of ASCs are accredited by an AO § Exempt from surveys conducted by SSA, except for: • Complaint surveys • Validation surveys

II. 2. Data on HAI Risks in ASCs is Lacking q National estimates regarding HAI risks associated with care provided in ASCs are not available § Surveillance infrastructure largely absent § Outbreak reports (e. g. , 2008 Las Vegas NV hepatitis C virus) q Little is known about infection control practices § To better assess practices , an enhanced inspection pilot activity was led by CMS with support from CDC* § In 2008, State Survey Agencies in Maryland, North Carolina, and Oklahoma) incorporated an infection control audit tool, based upon Standard Precautions, into their routine ASC survey process § Over two-thirds of the facilities surveyed in the pilot had lapses in infection control identified by surveyors * Schaefer et al. JAMA, June 9, 2010

II. 2. Data on HAI Risks in ASCs is Lacking q Government Accountability Office (GAO) Report (2009) “The increasing volume of procedures and evidence of infection control lapses in ASCs create a compelling need for current and nationally representative data on HAIs in ASCs in order to reduce their risk. Because HAIs generally only occur after a patient has left an ASC, data on the occurrence of these infections—outcome data—are difficult to collect. But data on the implementation of CDC-recommended infection control practices—process data—in ASCs can be collected more easily and can provide critical information on why HAIs are occurring and what can be done to help prevent them. ”

III. PROGRESS MADE 1. Expanded Cf. Cs for Infection Control / Prevention q q Revised ASC Conditions for Coverage, Interpretive Guideline and Survey Procedures (2009) For the first time, the Cf. Cs for ASCs specifically addressed th need for infection control programs, including: § Maintain an infection control program based upon nationally recognized infection control guidelines § The infection control program be under the direction of a designated healthcare professional with training in infection control § The infection control program be integrated into the ASC’s Quality Assessment and Performance Improvement Program (QAPI) § Prevent, identify and manage HAIs through its infection control program activities conducted in accordance with recognized infection control surveillance practices

III. PROGRESS MADE 2. Improved Inspection Frequency / Methodology q q q Historically, ASC surveys were infrequent (> 5 years) and did formally assess infection control American Recovery and Reinvestment Act (ARRA) funding enabled surveys of one third of all ASCs Routine survey process modified to use tracer methodology new Infection Control Worksheet

III. PROGRESS MADE 2. Improved Inspection Frequency / Methodology q Infection Control Worksheet § Section 1 – ASC characteristics • Type of ASC, scopes of services, organization of its infection control program, training/qualifications, use of nationally recognized standards and/or guidelines, surveillance methods § Section 2 – Infection Control Practices Assessment • Specific practices in five critical areas of infection control: o hand hygiene and use of personal protective equipment o injection safety and medication handling o equipment reprocessing (e. g. , sterilization and high-level disinfection) o environmental cleaning o handling of point-of-care devices (e. g. , blood glucose monitoring equipment)

III. PROGRESS MADE 3. Education and Training q q Increase in number and types of resources to support HAI prevention efforts in ASCs Surveyors § 2. 5 day training program for ASC surveyors (Oct 2009) § Web-based surveyor training course in development q Front-line ASC staff § Association for Professionals in Infection Control and Epidemiology (APIC) and Association of peri. Operative Registered Nurses (AORN), have developed education programs and conference content § ASC Quality Collaboration Toolkits § CDC and AHRQ websites § CDC hand hygiene and ASC training videos § Private continuing education providers

III. PROGRESS MADE 4. Interagency Collaboration q Across HHS, steadily increasing levels of information exchan consultation, and collaboration between the Operating Divisions, including CMS, CDC, AHRQ, IHS, and the Food and Drug Administration (FDA) q CMS-CDC interagency agreement to enhance CMS expertise and capacity to provide oversight of infection control activit with initial focus on ASCs q AHRQ has identified ambulatory care as a high-priority area HAI prevention and surveillance research, as demonstrated recent funding initiatives

IV. REMAINING NEEDS AND PREVENTION OPPORTUNITIES q Unmet needs pertaining to HAI prevention in ASCs fall into three main categories: § Proactive HAI prevention at the clinic level § Sustain and expand improvements in oversight and monitoring § Develop meaningful HAI surveillance and reporting procedures

IV. NEEDS AND OPPORTUNITIES 1. Proactive HAI prevention at the clinic level q q q Oversight and regulation “necessary but not sufficient” Improved recognition and understanding of risks Survey process not designed to address education gaps Need for educational resources and training Potential benefit from regular access to a certified Infection Preventionist Can we move ASCs toward a culture of safety and increase focus on HAI prevention and risk reduction, without the threat of an impending survey or citation?

IV. NEEDS AND OPPORTUNITIES 2. Sustain and expand improvements in oversight an monitoring § Improved survey frequency and methodology represent step in the right direction • However, surveys are relatively infrequent and only offer “snapshots” • Systematic review and analysis of survey findings (CMSCDC) § Enhancements and continuation of current improvements seem desirable but may be challenging to sustain

IV. NEEDS AND OPPORTUNITIES 3. Develop meaningful HAI surveillance and reportin procedures § Build on progress made in process measurement to move toward surveillance of patient outcomes (i. e. , HAIs) • Link process measure compliance with improved outcomes § No “one size fits all solution” § Post-discharge follow-up methods including surgeon or patient reporting are problematic (see TABLE 1 in draft module) § Many high volume ASC procedures lack standardized HAI surveillance definitions § For some procedures that are under surveillance in hospitals, need research on translation to ASC setting • Several states requiring ASCs to report SSIs using NHSN o E. g. , Colorado: hernia procedures, hip/knee replacements

IV. 3. Develop meaningful HAI surveillance and reporting procedures (continued) § Novel approaches using electronic data sources to identify potential SSI events originating in ambulatory settings • Identify and describe ambulatory procedures resulting in surgical site infections based on a subsequent procedure or acute care hospitalization • E. g. , AHRQ-funded study in collaboration with CMS using administrative data from HCUP (Healthcare Cost and Utilization Project) o Quality indicator specifications o Pilot national ambulatory surgery database • E. g. , CDC-funded studies using automated data from a managed care organization and HCUP state ambulatory surgery databases o Pharmacy dispensing data

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS 1. Improve and consider expanding process measures 2. Establish surveillance criteria and associated strategies for outcomes measurement 3. Identify needs and opportunities for HAI reduction through improvements in the process of care 4. Disseminate evidence-based guidelines and training for infection control 5. Engage stakeholders to facilitate collaboration and promote culture of safety 6. Obtain consensus on measurable 5 -year goals 7. Extend HAI prevention actions developed for ASCs to other outpatient surgery venues

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS § Work with AOs to identify best practices to promote HAI prevention initiatives; measure benefits of accreditation in terms of HAI risk reduction; and assure timely and appropriate communication with SSAs, State Health Department officials, and CMS regarding ICWS and related inspection findings § Work with CMS Quality Improvement Organizations (QIOs), State HAI Programs, A Os, and other stakeholders to develop and promote a patient-centered culture of safety in the ASC setting § Use the AHRQ Medical Office Survey on Patient Safety Culture to obtain baseline cultural assessments and work with stakeholders to adapt the survey specifically to ASCs § Identify strategies to involve consumers and others on an ongoing basis

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Identify Needs and Opportunities for HAI Reduction Through Improvements in the Process of Care q Reviews of infection control deficiencies identified through inspections q Consultations with certified Infection Preventionists q Healthcare safety and human factors specialists q Risk assessment approaches optimized infection control procedures scalable process of care, device, or facility design improvements

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Disseminate Evidence-Based Guidelines and Training for Infect Control Uptake of infection control and prevention guidelines and understanding of underlying disease transmission principles is lacking q CDC Summary Guide to Standard Precautions and Basic Infection Control for Ambulatory Care Settings q Continue to increasing training opportunities, as described above

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Improve and Consider Expanding Process Measures q q Adapt/adopt CMS’ Surgical Care Improvement Project (SCIP)for procedu that are being performed in ASCs Currently, there are six National Quality Forum (NQF)-endorsed measur adopted by the ASC Quality Collaboration* § Additional measures that address HAI prevention are needed • In addition to the need for measures specific to surgical site infection prevention, endoscope reprocessing is a specific area that would likely benefit from quality measure development • Further evaluation and stakeholder input is needed in this area patient burn; prophylactic intravenous antibiotic timing; patient fall in the ASC; wrong site, side, patient, procedure, or implant; hospital transfer/admission; and appropriate surgical site hair removal *

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Establish Surveillance Criteria and Associated Strategies for Outcomes Measurement q q q Research is needed to inform how HAI surveillance can most effectively conducted in ASCs Determine which procedures are the highest priority for tracking of infectious complications Current and next steps: § Robust estimates of #s and types of ASC procedures § Research into SSI and other HAI surveillance methods including electronic data mining and clinical validation § Improve health department capacities for identifying potential infections and outbreaks among ambulatory surgery patients

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Obtain Consensus on Measurable 5 -Year Goals Process Measures (First Breakout Session) P 1. By December 31, 2015, all certified/accredited ambulatory surgical centers will demonstrate 100% adherence to the following measures contained within the current infection control worksheet: - Staff perform hand hygiene before performing invasive procedures (e. g. , placing an IV); - Needles and syringes are used only for one patient; - Single-dose vials, IV solutions, and IV tubing are used only for one patient; - Items undergoing sterilization and high-level disinfection are precleaned appropriately; and, - Any fingerstick testing is conducted using only a single-use autodisabling lancing device for each patient.

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Obtain Consensus on Measurable 5 -Year Goals Process Measures (First Breakout Session) P 2. By December 31, 2015, all certified/accredited ambulatory surgical centers will demonstrate 100% adherence to Surgical Care Improvement project/National Quality Forum infection process measures (i. e. , perioperative antibiotics, hair removal, postoperative glucose control, normothermia). P 3. By December 31, 2015, and within two years of National Quality Forum endorsement, all certified/accredited ambulatory surgical centers will have implemented any new applicable healthcare-associated infectionrelated measures (e. g. , endoscope reprocessing, immunization). P 4. By December 31, 2015, all certified/accredited ambulatory surgical centers will have on staff or on contract the services of a certified infection preventionist.

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Obtain Consensus on Measurable 5 -Year Goals Outcome Measures (Second Breakout Session) O 1. By December 31, 2011, identify selected common ambulatory surgical center surgical procedures for which surgical site infection definitions and methods should be developed and develop a multi-year plan and phased approach to support routine surveillance. O 2. By December 31, 2013, all certified/accredited ambulatory surgical centers will have in place a surveillance system for procedure-related adverse events, including no less than 30 days post-discharge surveillance for all patients.

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Obtain Consensus on Measurable 5 -Year Goals Outcome Measures (Second Breakout Session) O 3. By December 31, 2015, all certified/accredited ambulatory surgical centers will be reporting surveillance data in standardized formats to both Patient Safety Organizations and to the National Healthcare Safety Network. O 4. By December 31, 2015, all certified/accredited ambulatory surgical centers will have achieved a zero incidence of “Never Events” as defined by the National Quality Forum.

V. NEXT STEPS: COLLABORATIONS FOR SHARED SOLUTIONS Extend HAI Prevention Actions Developed for ASCs to Other Outpatient Surgery Venues q ASCs only represent a subset of the ambulatory care facilities performing surgical procedures q Physician-run, office-based surgical practices perform procedures that are identical or similar to those conducted in ASCs, but many of these facilities are not subject to any regulatory oversight beyond physician licensure and are not being evaluated through an inspection process q While little is known about infection control and HAI rates in ASCs, even less is known about what is occurring in these other types of facilities q Future efforts directed toward ASCs, particularly related to educational outreach, need to be mindful of this group

Submitting Written Comments q q q The Office of Healthcare Quality is soliciting public comment on the HHS Action Plan to Prevent Healthcare. Associated Infections draft Tier 2 Modules Comments on the draft Tier 2 Modules should be received no later than 5: 00 pm on October 11, 2010 Comments are preferred electronically and may be addressed to OHQ@hhs. gov. Written responses should be addressed to Department of Health and Human Services, Office of Healthcare Quality, 200 Independence Ave, S. W. , Room 719 B, Washington, D. C. 20201, Attention: Draft Tier 2 Modules http: //www. dhhs. gov/ophs/initiatives/hai/actionplan/index. html

Breakout 3—Strategies for Success q Please suggest activities/policies likely to facilitate implementation of evidence based-practices? Possibilities include: changing accreditation standards, staff training (requirements, minimal standards), performance and outcome measurement, third-party payer financial incentives and payment policies? q Improving surveillance of process and outcome measures is of vital importance for monitoring quality. What are the significant obstacles you foresee in implementing surveillance programs and state and/or national reporting in ASCs? How can these be overcome? q What do you think are the highest priorities for national action to help enhance HAI prevention in ASCs? q Within your specialty’s or your organization’s area of expertise and/or focus, what are some priorities you plan to focus on in the next 12 -24 months to help enhance HAI prevention in ASCs?

Thank you The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases