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Asking the Right Questions_ Using Known HIT Safety Issues to

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									 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
              My presentation

• 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
Varied Perspectives:


    Clinical medicine
  Medical Informatics
Information Technology
          Safety
       R&D ethics
      Management
                        Health IT Risk:  
    Why Do We Need to Ask the Right Questions?


•   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
 Credo of Victor P. Satinsky, MD
      NSF SSTP Program
Hahnemann Medical College, 1972




 • Critical Thinking Always - Or
        Your Patient’s Dead
      Special Accommodation
• The health IT industry for decades has received 
  unprecedented special 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.
      Clearing up misconceptions 
that can impair needed caution– “EHR”
Reality:  complex enterprise Clinical Resource
Management and Workflow Control System – 
            many things can go wrong
Clinical IT is a proven technology.




     – No, it remains experimental.
         Luddites vs. “Ddulites”
• 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?
                                  “Anecdotes”
• 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 
                  Marketing Misinformation

• 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 
    More marketing misinformation
• "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 will improve caregivers’ decisions and 
       patients’ outcomes. Once patients experience the benefits of this 
       technology, they will demand nothing 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? 
           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)
                 IOM: Impediments to transparency




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.
Social impediment to transparency




             • Fear
    Rules of thumb on surveys and reporting

•   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.
                     Early hazard “taxomomies”: 
              Koppel (sociologist) – via direct observation

•   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. 
Taxonomy of health IT hazards – FDA (2010)
Taxonomy of hazards – AHRQ Health IT Hazard Manager (2012)    




                                            AHRQ Publication No.
                                            12-0058-EF, May 2012 
       Thinking critically…trust issues

• 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.
                 Recommendations (1)
•   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 (2)

•   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
                    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 
For more information

								
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