Asking the Right Questions: Using Known HIT Safety Issues to Improve Risk Reporting and Analysis

1. Asking the Right Questions:  Using Known HIT Safety Issues to Improve Risk Reporting and Analysis Scot M. Silverstein, MD Adjunct Professor, Institute for Healthcare Informatics College of Information Science & Technology Drexel University, Philadelphia, PA July 24, 2012

2. Industry special accommodation a major problem Clearing up health IT misconceptions and misinformation Impediments to transparency on risk Rules of thumb on surveys and reporting Taxonomies of healthcare IT risk Recommendations My presentation

3. Varied Perspectives: Clinical medicine Medical Informatics Information Technology Safety R&D ethics Management

4. Safety cannot be achieved through passive analysis of current data Transparency problems and marketing impair risk awareness Lack of risk awareness (and fear factors) impair reporting End result: marked under-reporting Health IT Risk: Why Do We Need to Ask the Right Questions?

5. Critical Thinking Always - Or Your Patient’s Dead Credo of Victor P. Satinsky, MDNSF SSTP ProgramHahnemann Medical College, 1972

6. The health IT industry for decades has received unprecedentedspecial regulatory accommodation compared to other healthcare sectors (e.g., pharma, tangible medical devices) as well as other safety-sensitive industries (aviation, automotive, energy etc.) This has not been earned, and is at odds with the ethics of modern medicine. Special Accommodation

7. Clearing up misconceptions that can impair needed caution– “EHR”

8. Reality: complex enterprise ClinicalResource Management and Workflow ControlSystem – many things can go wrong

9. No, it remains experimental. Clinical IT is a proven technology.

10. Do physicians/nurses resist clinical IT being pushed by reformers and modernists because they are Luddites (so ignore them)? OR: Are physicians/nurses in reality pragmatists resisting clinical IT being pushed by hyperenthusiasts (“Ddulites”) who ignore the downsides and ethical considerations? Luddites vs. “Ddulites”

11. Are case reports of health IT unintended consequences (UC’s) “anecdotal” and to be played down, while studies of health IT benefits to date solid science? OR: Are studies of health IT benefits to date mostly anecdotal (e.g., specialized settings, non-RCT’s) while reports of UC’s are risk management-relevant case report “red flags” pointing to possible systemic problems? See http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html “Anecdotes”

12. Clinical IT is always effective, beneficent and cost-saving. No: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist “Certification” of clinical IT is synonymous with proof of safety No: http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html Marketing Misinformation

13. "The 'Meaningful Use' Regulation for Electronic Health Records", Blumenthal D., Tavenner M. (NEJM, July 13, 2010) The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs willimprove caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demandnothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. Where is the list of peer reviewed, rigorous studies that back the assertions of certainty, and override the body of literature that cast doubt on these assertions? More marketing misinformation That acronym again!

14. FDA: Impediments to transparency (MAUDE) (Internal FDA memorandum of Feb. 23, 2010 ("not intended for public use") to Jeffrey Shuren on HIT risks, http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf)

15. IOM: Impediments to transparency No specific repository Hold Harmless Clause Gag clause IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press, pg. S-2.

16. Fear Social impediment to transparency

17. If you don’t ask the right questions, at the right time, and provide a venue for unbiased data provision, your results will be of diminished or no value. Passive analysis of clinical IT risk/harms data in an industry where lack of knowledge and misconceptions abound will produce suboptimal results. Ross Koppel, PhD - Feb. 25, 2010 ONC Policy Committee Adoption/Certification Workgroup on IT safety: "We don't know 99 percent of the medication ordering errors that are made [due to difficulty in recognition, lack of proper studies and other factors]. If 100 percent of the known errors were reported, that would be 1 percent of the [true] total. But the data suggests that the maximum on voluntary reporting is about 5 percent. So 5 percent of 1 percent that is what we know is reported...." Knowledge discovery techniques such as data mining can help, but cannot discover that which is not there - you can't data mine if you don't have relevant data points in the dataset. Rules of thumb on surveys and reporting

18. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203. Found that a widely used CPOE system facilitated 22 types of medication error risks. Examples include fragmented CPOE displays that prevent a coherent view of patients' medications, pharmacy inventory displays mistaken for dosage guidelines, ignored antibiotic renewal notices placed on paper charts rather than in the CPOE system, separation of functions that facilitate double dosing and incompatible orders, and inflexible ordering formats generating wrong orders. Three quarters of the house staff reported observing each of these error risks, indicating that they occur weekly or more often. Not a versioning issue. Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety. J Am Med Inform Assoc. 2008 Jul-Aug;15(4):408-23. The authors identified 31 types of causes of workarounds, such as unreadable medication barcodes (crinkled, smudged, torn, missing, covered by another label); malfunctioning scanners; unreadable or missing patient identification wristbands (chewed, soaked, missing); nonbarcoded medications; failing batteries; uncertain wireless connectivity; emergencies. The authors found nurses overrode BCMA alerts for 4.2% of patients charted and for 10.3% of medications charted. Possible consequences of the workarounds include wrong administration of medications, wrong doses, wrong times, and wrong formulations. Early hazard “taxomomies”: Koppel (sociologist) – via direct observation

19. Taxonomy of health IT hazards – FDA (2010)

20. Taxonomy of hazards – AHRQ Health IT Hazard Manager (2012) AHRQ Publication No. 12-0058-EF, May 2012

21. Taxonomies mostly observationally developed. Could have been done by industry a long time ago. That they are being developed only now is strong indication industry has done a poor job at self-policing (for > 30 years). Aware, or should have been aware, or should have made it their business to be aware. Thinking critically…trust issues

22. Reporting requirements of clinical IT risks, near misses, and harm events should be legislatively required. Set up or enhance state resource, e.g., PA-PSRS (Pennsylvania Patient Safety Reporting System) for facilities and clinicians to report problems they experience in a confidential manner, protected from vendor and hospital retaliation. (State should not wait for Federal database.) Make the resource known to the medical community. “Ask the right questions; don’t be passive.” Develop templates consistent with extant taxonomies, for use in education and reporting. Education on known risk modes for hospital executives, clinicians should be mandatory so that reports are most meaningful. Recommendations (1)

23. Legislatively prohibit “gag” clauses; provide retaliation remedies. End special accommodation. Act on reports as if acting on reports of medication, medical device, automotive, aviation etc. risks or accidents. Slow down – unfortunately,federal incentives and hyper-enthusiasm make that difficult. ? Informed consent – human subjects protections Recommendations (2)

24. More Reading • “Common Examples of Healthcare IT Difficulty.” http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ • Healthcare Renewal Blog (multi-author). http://hcrenewal.blogspot.com • “Reading List on Health IT”. http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist

25. For more information