1. The Crisis of Non-Reporting: Where does this go JH Lange - Presenter Co-authors/contributors Luca Cegolon Giuseppe Mastrangelo

2. The Institute of Medicine (IOM) Report in 1999 To Err is Human Raised the issue of preventable deaths as related to medical care

3. The IOM report described two different systems for disclosing and reporting errors. There are two types of reporting systems: Mandatory reporting Voluntary reporting Marschev, et al., 2003

4. VOLUNTARY -Confidential -Fully protected -Improve patient safety and quality -Broad set of errors – usually no or minimal harm (used to detect weakness in systems) Marschev, et al., 2003

5. Mandatory -Serious/adverse events -State government collect data -Available to public publics right to information on unsafe conditions question how to protect the public Marschev, et al., 2003

6. Mandatory Requirements Greatly Vary Different definitions Different time frames Different information to be reported Different consequences (criminal, civil, administrative) Different confidentiality Health Compliance Association, 2008

7. Comparison of IOM recommendations for mandatory and voluntary systems What is purpose of system MandatoryAccountability VoluntaryQuality improvement Marschev, et al., 2003

8. Comparison of IOM recommendations for mandatory and voluntary systems Who administers system MandatoryState VoluntaryPrivate Marschev, et al., 2003

9. State reporting - Pennsylvania The Medical Care Availability and Reduction of Error (Mcare) Act. Act 13 of 2002, Act of March 185 2002, PX,. 5 No, 13 (40 P.S. §13G3-101- 1303,910),(also Act 52 of 2007) Tied to medical liability - Medical Professional Liability Catastrophe Loss Patient safety through Department of Health

10. State reporting - Pennsylvania Report serious events and incidents Applies to 525 health care facilities and 700 Nursing homes Comparing apples and oranges these are not all the same form of institution

11. Examples of errors - Pennsylvania Errors in the prescribing, transcribing, dispensing, administering, and monitoring of medications; Wrong drug, wrong strength, or wrong dose errors; Wrong patient errors; Confusion over look-alike/sound-alike drugs or similar packaging; Wrong route of administration errors; Calculation or preparation errors; and Misuse of medical equipment.

12. Examples of errors - Pennsylvania Requirements says, not limited to these types of errors This information is health care work product Disclosure requires identifiers removed Are rates reported uniform?

13. Federal Requirements Device users facility adverse events (21 CFR 803) Vaccines health care providers reports (42 USC 300aa-25) Blood products (7 CFR 606) Health Compliance Association, 2008

14. Balancing protection and disclosures

15. Blame for errors Mistakes happen Most put blame on an individual Common is intimidation – blame for error Protection of institution and management Lack of real/practical training Creates a culture of under-reporting Tied to punishment rather than improvement

16. Non-reporting - Nurses In nursing career recall error of medication was 2.2 For incident report, Nurse Managers rate of medication errors was 42.1 percent Where are the rest? – Bullying, Fear of Punishment, Lack of Training, Non-cooperation with Management Majd, 2007

18. Is reporting the real problem Hospitals capture and report only 14 percent of adverse events From a sample of 780 patients out of 1 million Medicare beneficiaries in 2008 Roehr, 2012

19. How much is really missed The issue is unquestionably under reported 50 to 96 percent unreported One million errors are preventable annually Medical judgment of what a medical error Chamberlain et al., 2012

20. Colorado – under reporting First two years – 17 reports Next ten years – 1,000 reports New York – 20,000 reports annually Journal Editorial Staff, 2008

21. Rate per resident/100,000 Indiana – 1.75 Minnesota – 2.25 Wyoming – 2.75 Washington – 2.85 Connecticut – 4.75 New Jersey – 5.20 Journal Editorial Staff, 2008 (approximate rates)

22. Variation in what is reported Hospital -Acquired infections California – not necessary (related to adverse event) Colorado – Yes Florida – No Indiana – Optional Pennsylvania – Yes, but through a separate system Journal Editorial Staff, 2008

23. Solutions to what is missed Capture-recapture method (CRM) used in epidemiology and ecology Determines ascertainment and undercounts Can provide a statistical confidence Lange, 2003

24. Capture-Recapture Method (CRM) Has been applied to counting hazardous waste sites Considered the gold standard for counting Has limitations Must have at least two independent sources of data (counts) Lange, 2003; 2003a

25. CRM - application Has been applied to identifying causes of deaths for an accurate estimate Could be used for Pharmacy errors – one source from end users and other from preparers Here the question is - how many missed medication errors occur (originating from Pharmacy) Could use subsamples of data Porapakkham, 2010

26. Harm What constitutes harm or even a near miss What is disclosure? Defining criteria for voluntary and mandatory Who does this?

27. Comparisons Possibly only trends for states Maybe comparisons among similar reporting items alone Acquired infectious diseases Colorado and Connecticut Do they both have the same infectious diseases?

28. Payment Systems Pay for performance California - None Florida - None Pennsylvania – Yes (Department of Welfare will provide quality improvement payment for facility with 10 percent reduction) Journal Editorial Staff, 2008

30. Mandatory Reporting 27 States require hospital reporting (2007 – 30 states had some form of reporting requirement) 17 State mandate Pharmacy quality improvement Brought about by IOM report (1999) Na tional Association of Boards of Pharmacy, 2011; Health Compliance Association, 2008

31. Funding Disparity in funding makes reporting inconsistent among states Pennsylvania – $5 million Minnesota - $410K Washington - $127K Nalder, 2010

32. Purpose of reporting system determines disclosure - Colorado Purpose of System “…to improve access to reliable, helpful, unbiased information concerning the quality of care and the safety of the environment offered by each health care facility.” Marschev, et al., 2003 Disclosure State disclosures facility-identified and individual incident data.

33. Purpose of reporting system determines disclosure - Utah Purpose of System “…to help the Department and health care providers to understand patterns of systems’ failures in the health care delivery system.” Marschev, et al., 2003 Disclosure State limits access to identifiable information that facilities reports to the Department in order to enhance compliance and use data for state and system-wide improvement.”

34. Rhode Island Here the Department of Health wants to apply these hospital reports for license investigations and for purposes of allowing the public access to aggregated information for all hospitals to track trends The information would be included in health care quality reporting systems This is a some what epidemiological approach Marschev, et al., 2003

35. Mandatory reporting – What information is disclosed What type and amount of information provided? Individual Incident-specific Aggregate Marschev, et al., 2003

36. Type of Information Disclosed Type of report Colo Minn Penn Utah Periodic Aggregate reports XX X X Facility specific Aggregate information XX Individual Incidents X Marschev, et al., 2003

37. Comparison advantage of aggregate and individual incident reports Aggregate reports Show trends Enable consumers to see broad range of possible problems and thus ask appropriate questions about given procedures Marschev, et al., 2003 Incident-specific report Hold individual facilities accountable Give customers information that will facilitate choosing safest facility Provide sufficient detail to allow through analysis of case

38. Variation among states Individual reporting may be a result of no protections setup when first established This does create accountability Also depends on who can access information Why report to be listed Most state only report aggregate data Marschev, et al., 2003

39. Content of reports - Examples Content ColoradoUtah Description information X X Authority reporting system X Define reportable events X Number incidents reported X Number/type incidents-facil X Under-reporting as problem X Recommendation-improv X X Marschev, et al., 2003

40. Minnesota/Indiana – reportable events Has 28 types of events Categories Surgical Product or device Patient protection Case Management events Environmental events Criminal events

41. Patient Type of patient varies Type of facility varies Amount of services vary Conditions vary

42. How information released Website – Colorado (Individual report) Website – Most states (aggregate reports) Request for data – Freedom of Information Marschev, et al., 2003

43. Disclosure Barriers Concern data would be invalid and misleading due to underreporting Fear of malpractice litigation (creates opposition regarding disclosure) State establish cooperation and relationship that is not seen as punitive Marschev, et al., 2003

44. Under Reporting Lack of effective internal systems Unclear definitions or requirements Reporting burden and lack of perceived usefulness Fear of liability and negative publicity Lack of enforcement Marschev, et al., 2003

45. Why Protect Data To encourage full compliance Legal protections when reporting Business damage Fairness and due process Individual privacy Why really report – no benefit Marschev, et al., 2003

46. Common Data Protections HIPAA regulations Individual incident reports Provider identifiers (individual/institutional) Material generated in peer review Marschev, et al., 2003

47. Trend relating to greater protection Pre-1999Post-1999 Comprehensive ColoradoConnecticut Protection – specific FloridaGeorgia KansasMaine New YorkMinnesota Nevada Pennsylvania Tennessee Texas

48. Trend relating to greater protection Pre-1999Post-1999 Unprotected dataCaliforniaUtah Or depends on peerOhio ReviewMassachusetts New Jersey Rhode Island South Carolina South Dakota Washington Marschev, et al., 2003

49. Legal Protections – problem with comparison Colo PA Utah Data excluded from open X X X Record Not discoverable X X X Not subject to subpoena X X Admissible in disciplinary X X Procedure Data confidential X X X Marshev, 2008

50. Summary Personnel afraid to report Institution create culture for under-reporting Inconsistent criteria among states Lower rates hide problems

51. References Chamberlain CJ. (2012). Disclosure of “nonharmful” medical errors and other events: duty to disclose. Arch Surg 147:282-286. Health Compliance Association (2008). HCCA’s 12 th Annual Compliance Institute (April 13-16, 2008), New Orleans, LA (www.ebglaw.com/.../19269_health-event- anderson-hcca_compliance...)www.ebglaw.com/.../19269_health-event- anderson-hcca_compliance Journal Editorial Staff. (2008). A national survey of medical error reporting laws. Yale Journal of Health Policy, Law and Ethics. IX:1

52. Lange JH, Chang YF, LaPorte RE, Mastrangelo G.(2003). Hazardous waste site frequency: use of the capture-recapture method. Toxicol Ind Health. 2003;19:109-13. Lange JH, LaPorte RE. (2003a). Severe acute respiratory syndrome: capture-recapture method should be used to count how many cases of SARS really exist. BMJ. 21;326 (7403):1396.

53. Majd T et al., (2007). Rate, causes and reporting of medication errors in Jordan: nurses’ perspectives. J Nursing Mgt. 15:659-70. Marshev M, et al., (2003). How states report medical errors to the public: issues and barriers. National Academy for State Health Policy, Portland, (www.nashp.org)www.nashp.org Nalder E. (2010). Lawmaker: state’s medical-error reporting needs upgrade. www.seattlepi.com/.../Despite-law-medical-errors-likely- go-unreporte... National Association of Boards of Pharmacy (Jan., 2011). Medication error reporting: CQI programs offer avenue to vital follow-up. (NABP News Letter)

54. Porapakkham Y, Rao C, Pattaraarchachai J, Polprasert W, Vos T, Adair T, Lopez AD. (2010). Estimated causes of death in Thailand, 2005: implications for health policy. Popul Health Metr. 8:14 Roehr B. (2012). US hospital incident reporting systems do not capture adverse events. BMJ, Jan 13, 2012:e386