Implementation of Texas Healthcare-associated Infection and Preventable Adverse Event Reporting

1. Implementation of Texas Healthcare-associated Infection and Preventable Adverse Event Reporting Neil Pascoe RN BSN CIC Epidemiologist

2. Today • Federal Issues • State Process • Reporting (the who, what, when, and how)

3. Federal Healthcare Reform Currently No Mandate for HAI Reporting

4. Increasing Need for Public Health Approach Across the Continuum of Care Acute Care Facility Home Care Outpatient/ Ambulatory Facility Tranquil Gardens Nursing Home Long Term Care Facility

5. Current Landscape ofHAI Surveillance - Policy • Emphasis remains mandatory HAI reporting and public reporting of hospital-specific data • possible federal mandate • coupled with renewed interest in data validation • enabling greater public access to machine readable data sets

6. Current Landscape ofHAI Surveillance - Scientific Increasing interest in MDRO Clostridium difficile-associated disease HAIs in non-hospital settings LTCF and ASC Algorithmic detection of HAIs Risk modeling Use of observed-to-predicted (expected) ratios as summary statistics for comparative purposes (SIR)

7. Current Landscape ofHAI Surveillance -Technical • Renewed calls for system simplification • Increasing demand for technical solutions that make use of healthcare data in electronic form • Harmonizing data and reporting • Unprecedented federal support for healthcare information technology

8. Healthcare-Associated Infections (HAIs) Problem Bloodstream infections, urinary tract infections, pneumonia, surgical site infections Annual Impact 1.7 million HAIs in hospitals—unknown burden in other healthcare settings 99,000 deaths and $28-33 billion in added costs Solution Implementing what we know for prevention can lead to up to a 70% or more reduction in HAIs

9. National Initiatives • TJC- Patient Safety/NPSG/EOC • CMS- PAO/Reimbursement and Standards • AHRQ: improve the quality, safety, efficiency, and effectiveness of health care • NQF: setting priorities and goals for PI (SRE ≠ PAE) • PSO: The Patient Safety and Quality Improvement Act of 2005 • Consumer Advocates- Consumers Union- others • CDC: lead agency for many initiatives and coordination

11. HHS Action Plan to Prevent Healthcare-Associated Infections Development and Implementation

12. See: www.haitexas.org

13. Tier One Priorities HAI Priority Areas Catheter-Associated Urinary Tract Infections Central Line-Associated Bloodstream Infections Surgical Site Infections Ventilator-Associated Pneumonia MRSA Clostridium difficile Implementation Focus Hospitals

14. Measuring Success

15. Successful Implementation of Evidence-Based Guidelines Prevents Bloodstream Infections Successful Interventions • Sustained rates in Michigan hospitals for 5 years HHS Action Plan CLABSI Strategies • National Goal – 50% decline in 5 years • CDC – Develops guidelines • AHRQ – National expansion of proven effective interventions (Keystone/CUSP) • CMS – Report infection rates publicly on Hospital Compare • CDC & AHRQ – Standardize measures • CMS – Incorporate in Medicare Quality Improvement Organization portfolio 103 ICUs at 67 Michigan Hospitals BSIs per 1,000 Catheter Days Months Pronovost P. New Engl J Med 2006;355:2725-32

17. Caveats • There are some discrepancies in the legislation • There are staffing and funding issues • “RULES HAVE NOT BEEN WRITTEN” • Composition of the AP will change • We do not have all of the answers (or for that matter the questions)

18. Background • 78th legislative Session (2005) passed study bill • Advisory Panel • White paper • www.haitexas.org

19. Background • 79th legislative Session (2007) passed legislation (SB 288) • Advisory Panel • Reporting provisions • No appropriation • White paper • www.haitexas.org • www.texashai.org

20. Background • 80th legislative Session (2009) passed legislation (SB 203) (Amended SB 288 (aka Chapter 98 HSC) • Added two members to AP • PAE (28 NQF and CMS) • Causative agent • Medicaid reimbursement • Included appropriation

21. 81st Legislative Session: SB 203 • Originally a MRSA Reporting Bill • Finalized as ‘reporting pathogens’ per 80th legislative session SB 288 (public HAI reporting) … including MRSA, with • SB-7 didn’t become law; however, portions were “amended” into SB 203 (which was moving), eventually signed into law 6/19 • Therefore, SB 203 combines SB 288 law from last legislative session with SB-7 (not passed into law itself)

22. HEALTH AND SAFETY CODE CHAPTER 98. REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS HEALTH AND SAFETY CODE TITLE 2. HEALTH SUBTITLE D. PREVENTION, CONTROL, AND REPORTS OF DISEASES CHAPTER 98. REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS Chapter 98, consisting of Secs. 98.001 to 98.151, was added by Acts 2007, 80th Leg., For another Chapter 98, consisting of Secs. 98.001 to 98.009, added by Acts 2007, 80th Leg., R.S., Ch. 671, Sec. 3, see Sec. 98.001 et seq., post. SUBCHAPTER A. GENERAL PROVISIONS Sec. 98.001. DEFINITIONS. In this chapter: (1) "Advisory panel" means the Advisory Panel on Health Care-Associated Infections. (2) "Ambulatory surgical center" means a facility licensed under Chapter 243. (3) "Commissioner" means the commissioner of state health services. (4) "Department" means the Department of State Health Services. (5) "Executive commissioner" means the executive commissioner of the Health and Human Services Commission. (6) "General hospital" means a general hospital licensed under Chapter 241 or a hospital that provides surgical or obstetrical services and that is maintained or operated by this state. The term does not include a comprehensive medical rehabilitation hospital. … and so on

23. What has to be reported • Bloodstream infections associated with central lines • Surgical Site Infections • 3 pediatric • 7 adult • Preventable Adverse Events • National Quality Forum (SRE) • Non-reimbursed Medicare event or condition

24. Acute Care Reporting • ..a health care facility…shall report to the department the incidence of surgical site infections occurring in the following procedures: • Colon surgeries • Hip arthroplasties • Knee arthroplasties • Abdominal hysterectomies • Vaginal hysterectomies • Coronary artery bypass grafts, and • Vascular procedures

25. CLABSI • NHSN definitions • Laboratory confirmed • include the causative organism • special care setting in hospital • ICU/CCU/BurnICU • Not NICU

26. Pediatric Reporting • Cardiac procedures, excluding thoracic cardiac procedures • Ventriculoperitoneal shunt procedures < • Spinal surgery with instrumentation • Incidence of inpatient RSV

27. Healthcare-associated Infections Patient and procedure information for each reportable surgery • More than 10 reportable surgeries • Each reportable surgery regardless of associated infections • Over 72,000 knee replacement surgeries performed annually in Texas • Over 38,000 hip replacement surgeries performed annually in Texas • Infections occur with 1-2% of these surgeries

28. Approximate number of reports based on 2008 3rd quarter administrative (hospital) data 53,676 x 4= 214,704

29. Chapter 98 • Confidentiality • Same protections as notifiable conditions • Legal protections • Enforcement • Regulatory/licensing

30. Who has to report • 500+ general hospitals • Includes LTAC • Includes Pediatric and Adolescent • Excludes long term rehab hospitals • 350 ambulatory surgical centers

31. What does DSHS need to do? • Establish a reporting system • Provide education and training • Prepare a summary by health care facility • Succinct facility comments • Publish a summary at least annually • Make summary available on a website • Accept reports from the public • Perform data validations--validation tools • Functionality to conduct and track audits at hospitals and ASCs**

32. SB 288 Funding (2007) For FY 2008 DSHS requested $4.5M, 36 FTEs LBB calculated $1.1M and 5 FTEs FY 2009 DSHS requested $3.7M LBB calculated $1.2M and 8 FTEs Other scenarios presented No appropriation

33. HAI - Funding • General appropriation • $2,173,452 for the biennium and four new FTEs • American Recovery and Reinvestment Act (ARRA) • Awarded $710,872 to build surveillance infrastructure • Provided funds for two FTEs

34. TexasFunded Amount: $1,233,977 • State Contact: • Wes Hodgson, MPAState Plan Project Coordinator Healthcare-Associated Infections (HAIs) Emerging and Acute Infectious Disease Branch Infectious Disease Control Unit Division of Prevention and Preparedness Texas Department of State Health Services PO Box 149347 Mail Code 1960, Room T-809 Austin, Texas 78714-9347 • Phone: (512) 458-7111, extension 6364Fax: (512) 458-7616 • Wesley.Hodgson@dshs.state.tx.us • www.haitexas.org • Summary of Activity: • Activity ATexas has appointed a state healthcare-associated Infections (HAI) coordinator. This coordinator managed the convening of a multi-disciplinary group in late October to assist the state in the development of a statewide HAI plan. Comments and suggestions from this group were incorporated into the final draft of the Texas HAI Plan. The plan will be distributed to applicable facilities pending final approval, which is expected by mid-2010. However, many plan activities began implementation in late 2009 and others will begin in early 2010. • Activity BBy the end of Year 2, Texas will target the enrollment of all Texas acute care hospitals (n=517) into the National Healthcare Safety Network (NHSN) system. Reporting will begin following administrative activities. Monthly NHSN conferences are planned to address questions and issues. Facility reporting will enable the collection of state baseline data. In Year 2, aggregate reports and validation will begin, electronic reporting of laboratory data will be enabled, and quarterly statewide reports will be generated. A public Web site with facility-specific report-card information on HAIs will be made available as required by Texas law. • Activity CTexas will convene a multi-disciplinary advisory group that will establish and demonstrate collaboration. Participating facilities will be defined and selected, and one multicenter prevention initiative will be initiated. Currently, Texas is planning to target two prevention initiatives: central line-associated bloodstream infection (CLABSI) and surgical site infection (SSI), although more specific information for prevention targets will be identified.

35. DSHS staffing • Currently 5+ IDCU staff work on HAI-related activities in addition to other duties • (marilyn felkner, gary heseltine, wes hodgson, sky newsome, neil pascoe, jeff taylor) • New staff not yet • PS VI- manager • PS V- clinical specialist (CIC) • Epidemiologist • Administrative Assistant • IT support (larry beard, andy mauney)

36. When to Report • January 1, 2011 • April 1, 2011 • July 1, 2011

37. How to Report • Health care facilities shall report to a secure, electronic interface designated by the Texas Department of State Health Services. • NHSN • Health care facilities shall meet data reporting requirements and timeframes and utilize definitions as required by the secure, electronic interface.

38. Education and Training GR funding will allow for contracted training • State meeting in October 2010 • See www.haitexas.org • CDC/NHSN training

39. Reporting Mechanisms Considered Plan A: Missouri Healthcare System Associated Infection Reporting System- large IT project Plan B: National Healthcare Safety Network initially viewed as complex and burdensome to ICP currently recommended by HAI panel DSHS build IT system to receive/display NHSN data Plan C: Use Texas Hospital Discharge Data Network Already reaches statewide except rural hospitals and will be expanded to all ASCs under existing legislation Problems include data definitions, legal ability to share, contracts Plan D – as needed Option for public to report suspected HAIs to DSHS Poses significant challenges, particularly validation

40. Reporting System Training • Texas Healthcare Infection and Preventable Adverse Events Reporting System • NHSN for HAI?? PAE??? • Training via contract (TSICP, APIC or ?) • Initial, annual training and updates • Separate Data Validation Contract

41. How will Facilities Report? (The Reporting System) • National Healthcare Safety Network • Used by over 2,000 healthcare facilities in 50 states (2456 as of 1/18/10) • Healthcare facilities may enter data on: • Device-associated adverse events • Procedure-associated adverse events • Medication-associated adverse events

42. What is NHSN? • National voluntary, confidential system for monitoring events associated with health care • Initial focus on infections in patients and healthcare personnel (NNISS) • Expanding to include noninfectious events (such as process measures) • Accessed through a secure, web-based interface • Open to all US healthcare entities at no charge

43. NHSN • Managed by the Division of Healthcare Quality Promotion (DHQP) at CDC. • Open to all types of healthcare facilities in the United States, including acute care hospitals, long term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, outpatient dialysis centers, ambulatory surgery centers, and long term care facilities.

44. Data Sharing in NHSN: Groups • CDC does not send NHSN data to state health departments or other entities • Health departments or others obtain data directly from NHSN facilities – By becoming a group in NHSN – Facilities join the group and confer rights to certain data • The group can analyze the data of its member facilities • Facilities may join multiple groups

45. NHSN Eligibility Criteria • US healthcare facility listed in or associated with a facility that is listed in one of the following national databases: • American Hospital Association (AHA) • Centers for Medicare and Medicaid Services (CMS) • Veteran’s Affairs (VA). • high-speed Internet access • digital certificate on computers • willing to follow the selected NHSN component protocols exactly • report complete and accurate data in a timely manner during months when reporting data for use by CDC • willing to share such data with CDC for the purposes stated above. • provide written consent from facility’s chief executive leadership (e.g., Chief Executive Officer).

46. Challenges of NHSN • Enrollment process takes time • Digital Certificate installation can be cumbersome and must be done annually • IT support can expedite this process. • Standard definitions do not imply standard interpretations. • For CLABSI: What is the meaning of “organism from blood not related to an infection at another site”?

47. Challenges of NHSN, cont’d • Facility data collection must be standardized i.e. device days daily, at the same time of day • Numerator and denominator data submitted within 30 days of the end of the month • Cannot participate in Procedure Associated Module unless all required data elements are entered for every procedure and there are many data elements required…

48. Advantages of NHSN • Training is very thorough and explains, in detail, the “rules” for complying with NHSN surveillance protocols. • Definitions of infections are standardized • Software is user-friendly - minimal time spent entering “event” data and device days • Only have to report one module for a minimum of 6 months to maintain membership • National comparative data is available when reporting infection rates

49. Advantages of NHSN, cont’d • Surgical denominator data can be downloaded if the user has an electronic surgical record and all required data elements are contained in each record • Members are able to contact NHSN regarding surveillance questions and are able to receive assistance quickly • Members have input into the “usability” of the definitions • Members get advanced notice of any changes coming to NHSN surveillance criteria • Likely the reporting mechanism for the State of Texas? • Vendors have developed compatible software for uploading facility data

50. NHSN Change Control Process