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 Outpatient/ Ambulatory Facility Tranquil Gardens Nursing Home Home Care Acute Care Facility Long Term Care Facility

5. Current Landscape of HAI 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 of HAI 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 of HAI 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 HospitalsHospitals

14. Measuring Success MetricDataTarget Central line bloodstream infectionsNHSN ↓ 50% ↓ 50% Adherence to CLIPNHSN 100% 100% Hospitalizations with Clostridium difficileAdmin ↓ 30% > ↓ 30% Clostridium difficile infectionsNHSN ↓ 30% > ↓ 30% Catheter-associated urinary tract infectionsNHSN ↓ 25% > ↓ 25% MRSA incidence rate (healthcare- associated)EIP ↓ 50% > ↓ 50% MRSA bacteremia (healthcare facility-wide)NHSN ↓ 25% > ↓ 25% Surgical site infectionsNHSN ↓ 25% > ↓ 25% Surgical Care Improvement Program adherenceSCIP 95% > 95%

15. Successful Implementation of Evidence-Based Guidelines Prevents Bloodstream Infections BSIs per 1,000 Catheter Days Pronovost P. New Engl J Med 2006;355:2725-32 103 ICUs at 67 Michigan Hospitals Months 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

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 78 th legislative Session (2005) passed study bill –Advisory Panel White paper –www.haitexas.orgwww.haitexas.org

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

20. Background 80 th 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. 81 st Legislative Session: SB 203 Originally a MRSA Reporting Bill –Finalized as ‘reporting pathogens’ per 80 th 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. 53,676 x 4= 214,704 Approximate number of reports based on 2008 3 rd quarter administrative (hospital) data

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. Texas Funded Amount: $1,233,977 State Contact: Wes Hodgson, MPA State 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 6364 Fax: (512) 458-7616 Wesley.Hodgson@dshs.state.tx.us www.haitexas.org Summary of Activity: Activity A Texas 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 B By 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 C Texas 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.orgwww.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

51. Work Group Members and Liaisons NHSN sites – Elise McKee (CA), Teresa Accuntius (OH), Connie Steed (SC), Ellen Smith (CA), Dana Trocino (OR) State Health Departments – Rachel Stricof (NY), Steve Ostroff (PA), Neil Pascoe (TX) HICPAC – Russ Olmstead CDC – Chesley Richards, Joe Perz, Gautam Kesarinath, Ahmed Gomaa, Nancy Sonnenfeld CMS – Barry Straube (or Paul McGann) AHRQ- Bill Munier (or Amy Helwig) SHEA – Henry Blumberg (or Lisa Maragakis, Jesse Jacob) APIC – Patti Grant AHA – Kathy Ciccone (or Mary Therriault) CSTE – Marion Kainer ASTHO – James Kirkwood (or Belinda Haerum)

52. Projected NHSN Data flows

53. State-Summary Report of HAI Data Reported to NHSN As a Method of Measuring Progress Towards Elimination of HAIs

54. CDC State Summary Report Intent and Timeline First Report –Announcement of report in MMWR April 2 –CLABSI only report immediately available –Replace with CLABSI/SSI by May –Report on serial SIR, track progress –Evaluate possible impact of ARRA

55. Purpose of Report Enables CDC to evaluate progress using a summary statistic at the national, and State, level National Healthcare Safety Network (NHSN) used by hospitals in 50 States (plus Washington, DC and Puerto Rico); mandated in 21 American Recovery and Reinvestment Act of 2009 (ARRA) Included $50 million to support states in HAI prevention Requires regular reporting of impact HHS Action Plan towards the elimination of HAIs: http://www.hhs.gov/ophs/initiatives/hai/actionplan/index.html Enables states (without access to data) to gain insight into status of HAI/NHSN reporting, within current limitations of system Promote use of SIR as summary measure to HAI prevention community (other reports already in works)

56. Public report limited to states with mandate Sharing summary data with state officials Encouraging all facilities to work with state officials State Obscured Standardized Infection Ratio: No. expected / no. observed State-Summary Report of HAI Data Reported to NHSN

57. Data Tables in Report (DRAFT) ABCDEABCDE State B with mandate, high enrollment percent, and high data submission percent State D with no mandate, low enrollment percent, and high data submission percent

58. NHSN Performance and Usability Improvements

59. Performance Measurement Installed performance widgets on every page to measure user wait times as a function of time of day, request type, location and server load Currently monitoring this dataset and have a baseline from which to measure progress.

60. Performance Improvements (to be completed in the coming months) Re-engineer the NHSN database Reduce page sizes so that pages will load faster Streamline data input screens so that entering data will be easier Move away from the use of digital certificates to passwords Increase our ability to receive electronic messages to reduce manual data entry burden

62. The DSHS Data Display

63. Data Display

66. Roles of Local and Regional HD Education and Training Information and Data Validation Outbreak investigation Other activities???

67. Preventable Adverse Events Health care-associated adverse condition or event for which the Medicare program will not provide additional payment to the facility under a policy adopted by the federal Centers for Medicare and Medicaid Services; and Event included in the list of adverse events identified by the National Quality Forum that is not included under Subdivision (1). Different method for reporting Likely to have separate rules

68. Summary SB 203 went into effect 9/1/09 There will be more legislation Be watching in Texas Register for proposed and then adopted RULES to provide the ‘how to’ of these new laws

69. Thanks HAI and PAE AP (don’t you love acronyms?) Sharon Williamson, Patti Grant and NHSN HAI IPT TSICP

70. HAI Resources DSHS : www.haitexas.orgwww.haitexas.org Consumers ww.stophospitalinfections.org/ww.stophospitalinfections.org/ NHSN website: http://www.cdc.gov/nhsnhttp://www.cdc.gov/nhsn National Quality Forum: www.qualityforum.org/www.qualityforum.org/ AHRQ: http://www.ahrq.gov/http://www.ahrq.gov/ Centers for Medicare and Medicaid Services http://www.cms.gov/ HICPAC Guidance on Reporting HAIs http://www.cdc.gov/hicpac/pubReportGuide/pu blicReportingHAI.html

71. Questions or discussion?