Transcript Asking the Right Questions: Using Known HIT Safety Issues to

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-EventsInvolving-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 hyperenthusiasm 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