Regulatory Review

1. Regulatory Review What’s new? What’s different? October 21, 2011

2. Review CMS survey process requirements in surveillance, IP and quality assessment and performance improvement (QAPI) Describe important regulatory issues that may impact future surveillance practices Identify frequently-identified survey deficiencies in ambulatory care Objectives

3. Surveillance Serves Many Purposes Monitor adverse outcomes Detect clusters or outbreaks Assess and investigate prevention and control measures Inform QI program and staff training Supports compliance with best practices Ensure compliance with state/federal requirements and accreditation standards

4. What is our Surveillance Goal? • Shift emphasis from measurement of rates to prevention of infection • Integrate HAI prevention into an organizational culture of safety • Zero tolerance for preventable infections • If an infection is reported, find out why and respond – every time, every patient

5. Develop an Effective Surveillance Program 1.Select surveillance methodology 2. Assess and define population(s) to be studied 3. Choose indicators (events) to monitor 4. Determine time period for observation 5. Identify surveillance criteria

6. Develop an Effective Surveillance Program 6.Identify data elements to be collected 7. Determine methods for data analysis, collection and management 8. Calculate and analyze rates 9. Develop and disseminate reports 10.Use findings to improve practice

7. Complete a IC Risk Assessment Types of patients/clients served Most common diagnoses Types of surgical or other invasive procedures performed Risks of infection for procedures and treatments performed Which patients are at risk for infection Disease prevalence in the community and region

8. But … what does CMS require? §416.51(b): Infection Control Program • Conduct monitoring activities throughout entire facility in accordance with recognized infection control surveillance practices • Identify infection risks and communicable disease problems • Document monitoring/tracking activities, including measures selected for monitoring, and collection and analysis methods

9. From the CMS Interpretive Guidelines: §416.43(c) Program Activities Interpretive Guidelines: “If the ASC does not track measures related to infection control, it will not be in a position to determine whether or not its infection control program is working well or poorly, and thus will not be in a position to improve it.”

10. ASC Surveillance Methodology Standard Methods: Comprehensive (all infections, all sites) Priority directed (targeted) Combination of these CMS does not identify what surveillance methods the ASC must use. Benchmarks & other comparative data are extremely limited and may not be reliable. ASC surveillance reporting is considered very subjective.

11. Comprehensive Surveillance Monitors all infections in all patients, all procedures Labor intensive--required by some states Not sensitive enough to identify potential problems, monitor trends, or make comparisons

12. Priority Directed (Targeted) Surveillance Focuses on particular surgical procedures performed at ASC Focuses on significant organisms Focuses on high-risk, high volume Less labor intensive but can miss infections

13. Combination Targeted events in defined populations and Selected events in all patients Reminder:your surveillance methods should be included in the written descriptioon of your infection control program. CMS surveyors will look for evidence that are you conducting surevillance according to your plan.

14. What Does CMS Require? §416.51(b): Infection Control Program • Identifying Infections: • Monitoring includes follow-up of patients after discharge, in order to gather evidence of whether they have developed an infection associated with their stay in the ASC

15. Refer to ICWS for Specific Surveyor Questions 18. Does the ASC have a system to actively identify infections that may have been related to procedures performed at the ASC? 1 YES 2 NO 18a) If YES, how does the ASC obtain this information? (Check ALL that apply) 1 The ASC sends e-mails to patients after discharge 2 The ASC follows-up with their patients’ primary care providers after discharge 3 The ASC relies on the physician performing the procedure to obtain this information at a follow-up visit after discharge, and report it to the ASC 4 Other (please specify):

16. What Does CMS Require? §416.43 Condition for Coverage: Quality Assessment and Performance Improvement (QAPI) The ASC must develop, implement and maintain an ongoing, data-driven quality assessment and performance improvement (QAPI) program.

17. QAPI and Infection Control §416.51(b): Infection Control Program Must be integral part of ASC’s QAPI • Survey Procedures §416.51(b)(2) • Determine whether ASC’s QAPI program includes measures/indicators and activities related to IC on ongoing basis. • Determine if there is evidence that the QAPI IC activities result in specific actions designed to improve IC within the ASC

18. What CMS Requires: §416.43(a) Standard: Program Scope The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that include care and services furnished in the ASC

19. Surveillance Activities Should Reflect the Following QAPI Criteria §416.43(c) Standard: Program Activities The ASC must set priorities for its performance improvement activities that: (i) Focus on high risk, high volume, and problem-prone areas (ii) Consider incidence, prevalence and severity of problems in those areas (iii) Affect health outcomes, patient safety and quality of care

20. Types of Events to Monitor • Outcomes: • Result of health care • Patient-centered • Processes (or practices): • Actions, procedures, activities of health care • Includes quality control activities • Events of importance to the organization Interesting to note the CMS ICWS is being used to collect ASC process measures only, although the standard requires monitoring for outcomes

21. Outcomes vs. Process Measures Outcomes measures Process measures # employees receiving flu shot this year Handwashing compliance Compliance with HLD policies • SSI following defined surgical procedure • Emergent transfers to higher level of care • Unanticipated high volume blood loss following procedure

22. “ASCs must track all patient adverse events … “ § 416.43(c) Program Activities Examples may include: Multidrug resistant organisms (MDROs) in community and area healthcare facilities Lapses in safe injection practices Reportable diseases staff and patients Positive biological indicator (sterilizer test) Failed preventive maintenance/quality control checks on equipment, including sterilizers Any patient who presents at admission with an active infection

23. CMS Surveyors will check . . . Survey Procedures §416.43(a) • At a minimum, do the indicators include measures appropriate for surgery and infection control measures? Hint: Can staff identify what measures/indicators you are tracking in your ASC? Can they describe whether or not you are making progress toward your goal? Can they explain why you selected those measures? Keep staff involved in surveillance & QAPI!

24. How surveillance is performed may change – are you ready? What’s up in Washington … HHS, CDC and AHRQ

25. ASCs in the HHS HAI Action Plan Tier Two work has been underway since Q 4 2009

26. HHS HAI Action Plan Q: What should be the appropriate targets and metrics in ASCs? A: What may have worked in acute care does not translate to ambulatory care

27. Will reporting become mandatory? We are on our way to increased and/or mandatory ambulatory reporting

28. National Healthcare Safety Network The National Healthcare Safety Network (NHSN) is a voluntary, secure, internet-based surveillance system that integrates patient and healthcare personnel safety surveillance systems managed by the Division of Healthcare Quality Promotion (DHQP) at CDC. During 2008, enrollment in NHSN was opened to all types of healthcare facilities, including acute care hospitals, long term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, outpatient dialysis centers, ambulatory surgery centers, and long term care facilities. The CDC NHSN currently supports > 3200 hospitals in 30 states. There is NO FEE to participate but a facility must enroll. www.cdc.gov/nhsn

29. New Research May Impact ASC Surveillance AHRQ funded projects in the pipeline: • Use of administrative (coding) data to identify possible infection trends, clusters in ASCs

30. Summary • Surveillance is required in IP and QAPI programs (CMS §416.43 and 416.51) • Surveillance is a data-driven process that may track processes, outcomes or both • A surveillance system is based on risk assessment and specific ASC monitoring priorities • Surveillance must meet the requirements of federal, state and accrediting agencies

31. Summary (continued) • The focus of surveillance should be on prevention rather than detection • National initiatives underway at HHS, CDC, AHRQ et al may impact how/what you do in the short-term future

32. Resources • APIC Infection Prevention Manual for Ambulatory Care – 2011 update www.apic.org/source/orders/index.cfm?section=store&task=3&CATEGORY=BOOKS&PRODUCT_TYPE=SALES&SKU=SLS9804 • www.disinfectionandsterilization.org

33. Resources • Visit www.aaahc.org: • Handbook specific to Medicare Deemed Status ASCs • 855B enrollment process • Physical Environment Checklist (PEC) • Chapter by chapter Resource section • “Analyzing Your QI and Creating Meaningful Studies” template • Sample Application for Medical Staff Privileges • Audit tools for Clinical, Personnel and Credential records

34. Resources • Visit www.aaahc.org (contd): • Link to CMS SOM, Appendix L • http://www.cms.gov/manuals/Downloads/som107ap_l_ambulatory.pdf • Infection Prevention links • Recall announcements • Subscribe to FDA Medwatch at: https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_46 • Simple signup for electronic Application for Survey and upload supporting documents

35. … and now … what you love most!

36. Top 10 survey deficiencies #10 Supplies improperly stored #9 Outdated inventory – supplies and medications #8 Lapses in recordkeeping of logs • Medication/vaccine refrigerators • Monitoring of HLD solutions #7 Untimely staff emergency drills #6 Regular use of immediate use sterilization

37. Top 10 survey deficiencies #5 Outdated medical staff credentials and/or staff records; lack of ongoing monitoring for expiration #4 Lack of documented annual competency verification for staff performing high risk tasks #3 Lack of documentation of Governing Body consideration and selection of nationally-recognized guidelines for HH, safe injection

38. Top 10 survey deficiencies #2 Breaks or gaps in firewall, a Life Safety Code violation

39. Top 10 survey deficiencies #1 Manufacturer instructions/manuals and/or ASC Policy regarding high risk equipment (AER, endoscopes, lasers) or environmental cleaning solutions (CHG, hospital grade cleaner) are … not immediately present, or … staff cannot locate, or … staff “has never seen them”

40. Questions? Marsha Wallander mwallander@aaahc.org