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Reducing Medical Errors in POCT
Ohio POC
Christopher FETTERS
Global Manager, Upstream MarketingAbbott Point of Care
Point-of-carePoint-of-carePoint of Care:Point of Care:
Keeping “Humans” and “Errors” ApartKeeping “Humans” and “Errors” Apart
Point of Care:Point of Care:Keeping “Humans” and “Errors” ApartKeeping “Humans” and “Errors” Apart
© 2009. All Rights Reserved. Unauthorized duplication is a violation of applicable laws.© 2009. All Rights Reserved. Unauthorized duplication is a violation of applicable laws.
Reducing Medical Errors in POCT
Ohio POC
ObjectivesObjectives
• Understand Medical Errors Rates• Review Case Studies• Create Awareness• Share experiences• Inspire you to further research and
learning
• Not here to teach you how to perform an FMEA, Fault Trees, or Risk Analysis
Reducing Medical Errors in POCT
Ohio POC
Institute of MedicineInstitute of Medicine
Reducing Medical Errors in POCT
Ohio POC
To Err is Human - Building a Safer To Err is Human - Building a Safer Health SystemHealth SystemA Report From The National Academies of Science, Institute of MedicineA Report From The National Academies of Science, Institute of Medicine
• 44,000 – 98,000 patients killed each year by preventable medical mistakes
• Key Recommendations Focus greater attention on patient safety Center for patient safety National mandatory reporting Peer review protections FDA should increase attention to safe use of drugs
Reducing Medical Errors in POCT
Ohio POC
Principle of Risk CreepPrinciple of Risk Creep
• Risk Creep is when risks are accepted due to familiarity or saturation. This is a skewed perception. Result can be
a sudden crisis after years of acceptance.
• Example – highway injuries and fatalities. In 30 years, over one million deaths.
• People view nuclear power as a high risk, yet not a high risk statistically.
Reducing Medical Errors in POCT
Ohio POC
Nurse trainingNurse training
• Right Patient• Right Drug • Right Dose • Right Route• Right Time
770,000 untoward drug errors
Reducing Medical Errors in POCT
Ohio POC
It is not the strongest of the species that survives, not the most intelligent, but the one most responsive to change.
Charles Darwin
Reducing Medical Errors in POCT
Ohio POC
Causes of Medical MistakesCauses of Medical Mistakes
• 60-80% is human error Active errors
Latent errors
• 15-20% is mechanical failure
Reducing Medical Errors in POCT
Ohio POC
GoalGoal
• Goal in Point of Care?• Goal in the Laboratory?• Goal in the Hospital?
Golden Rule: Do unto others as you would
have them do unto your mother.
Golden Rule: Do unto others as you would
have them do unto your mother.
Reducing Medical Errors in POCT
Ohio POC
It can be simpleIt can be simple
• “er” – Season finale• Romano’s accident
Not this one
IDIOT
Reducing Medical Errors in POCT
Ohio POC
Three phases of laboratory testingThree phases of laboratory testing
• Pre-analytical
• Analytical
• Post-analytical
Reducing Medical Errors in POCT
Ohio POC
hile point-of-care testing (POCT)
has significantly improved the
timely
delivery of diagnostic information for
clinical
decision making, the wide range of
settings
and operators involved in POCT add a
layer
of complexity to an institution’s effort
to
ensure consistently high-quality
results.”
Gerald J. Kost, MD, PhD. “Using operator lockout to improve the performance of point-of-care blood glucose monitoring.” 2000.
WW
Reducing Medical Errors in POCT
Ohio POC
82% of Patient Data Still Manually 82% of Patient Data Still Manually RecordedRecorded
18%
82%
Downloaded Manually Entered
Source: 1999 EAC US Hospital POC Survey
Reducing Medical Errors in POCT
Ohio POC
Tighter Control=
Higher Quality=
Improved Safety=
Better Patient Care !!
Reducing Medical Errors in POCT
Ohio POC
Is 99.9% Good Enough?Is 99.9% Good Enough?• 1 hour of unsafe drinking water every month; • There will be no telephone, electricity or television for 15 minutes each day.
• 315 entries in Webster's Dictionary will be misspelled • 114,500 mismatched pairs of shoes will be shipped/year • 811,000 faulty rolls of 35MM film will be purchased this year.• 880,000 credit cards in circulation will turn out to have incorrect cardholder information
on their magnetic strips • 2,488,200 books will be shipped in the next 12 months with the wrong cover.• 5,517,200 cases of soft drinks produced in the next year will be flatter than a bad tire.
• 1,314 phone calls will be misplaced by telecommunications services every minute.• 18,322 pieces of mail will be mishandled/hour • 22,000 checks will be deducted from the wrong bank accounts in the next 60 minutes.• 2,000,000 documents will be lost by the IRS this year
• Your heart fails to beat 32,000 times each year. • Twelve babies will be given to the wrong parents each day.• 2,500 newborn babies will be dropped in the next month.• 107 incorrect medical procedures will be performed by the end of the day today.• 500 incorrect surgical operations each week; • 200,000 drug prescriptions will be filled incorrectly in the next 12 months.
• A typical day would be 24 hours long (give or take 86.4 seconds)Jeff Dewar
Reducing Medical Errors in POCT
Ohio POC
Healthcare Personnel Healthcare Personnel ShortagesShortages
As many as 168,000 hospital positions are unfilled in six selected job As many as 168,000 hospital positions are unfilled in six selected job categories. categories. Three out of four vacancies are nursing positionsThree out of four vacancies are nursing positions
Note: Other hospital professions include pharmacists, radiological technologists, laboratory technologists, billing/coders, and housekeeping/maintenance staff.
Other HospitalProfessions
25%
Registered Nurses75%
Reducing Medical Errors in POCT
Ohio POC
Harrisburg Sunday Patriot-News, September 9, 2001.
Reducing Medical Errors in POCT
Ohio POC
Three approaches to qualityThree approaches to quality
• Remedial Alleviate the symptoms of the existing
problem
• Corrective Eliminate the cause of existing problems
or undesirable situation to prevent recurrence
• Preventive Eliminate the cause of potential problems
Reducing Medical Errors in POCT
Ohio POC
Improving performance withoutchanging the process
is not process improvement, it’s performance improvement.
Tony Joseph
Reducing Medical Errors in POCT
Ohio POC
Quality PrinciplesQuality Principles
• Respect human limits in process design Avoid reliance on memory Use constraints and forcing functions
(eg, lockouts) Simplify and standardize the work process Anticipate the unexpected
• Adopt a proactive approach Design for recovery Improve access to accurate, timely
information Create a learning environment
Reducing Medical Errors in POCT
Ohio POC
Use Errors vs. User ErrorsUse Errors vs. User Errors
• Use error is repetitive and can be predicted.
• User error is due to fundamental errors by humans that has no possibility of prediction.
(Renamed Abnormal Use in the standards)
Reducing Medical Errors in POCT
Ohio POC
Use Error Examples from IEC Use Error Examples from IEC 6236662366• Operator confuses two buttons and presses the wrong button.• Operator misinterprets the icon and selects the wrong function.• Operator enters incorrect sequence and fails to initiate infusion.• Operator fails to detect a dangerous increase in heart rate because the
alarm limit is mistakenly set too high and operator is over-reliant on alarm system.
• Operator cracks catheter connector when tightening or loosening the connector.
• A centrifugal pump is cleaned with alcohol. It is made from material that is known to be incompatible with alcohol. It is reasonably foreseeable that alcohol might be used to clean the pump as alcohol is readily available in the hospital.
• Unintentional use of pipette out of its calibration range.• Analyser placed in direct sunlight causing higher reaction temperature than
specified.• Technician brings a steel oxygen tank into the presence of the magnet in
the MRI system suite and it moves swiftly across the room into the magnet.• Operator is under time pressure and uses a shortcut on excessively
lengthy instructions, procedures, pre-use checklist, etc, thereby abbreviating them.
Reducing Medical Errors in POCT
Ohio POC
Abnormal Use Examples from IEC Abnormal Use Examples from IEC 6236662366
The following abbreviated descriptions of events that occurred despite proper accompanying documents, proper design, and proper training, and were determined to be beyond any reasonable means of risk control by the manufacturer.
• Deliberate, premeditated violation of instructions, procedures, pre-use checklist, calibration, or maintenance, etc., as specified in the accompanying documents.
• Failure to stop using an X-ray tube after having ignored the warning light that indicates it is overheating. The X-ray equipment subsequently stops operating or fails and that delays or prevents completion of a therapeutic procedure.
• Use of equipment prior to completing installation or the initial performance checks as specified by the accompanying documents.
• Deliberate failure to conduct prescribed device checks prior to each use as defined by the accompanying documents.
• Continued use of equipment beyond the prescribed maintenance interval as clearly defined in the accompanying documents as a result of user’s failure to arrange for maintenance.
• Contrary to the instructions for use, the equipment was not sterilized prior to implantation.• Use of electrosurgical device on a pacemaker patient while deliberately ignoring the clear warning in
the instructions for use to take proper precautions, resulting in the need to re-program the pacemaker or explant the device. A pacemaker programmer is not available.
• Patient harmed because user had not ensured that the operator was adequately trained. The equipment is working in accordance to specifications.
• During placement of a pacemaker lead, an untrained physician perforates the heart.• The labelling for a centrifugal pump clearly indicates that it is intended for use in by-pass operations of
less than 6 hours in duration. Finding no other pump available, the clinician decides to use the pump in a paediatric extra-corporeal membrane oxygenation (ECMO) procedure that can last several days. The pump fails due to fatigue cracking and the patient bleeds to death.
Reducing Medical Errors in POCT
Ohio POC
Point of Care ErrorsPoint of Care Errors
• MD Pocket Developer Distilled Water Sensa v. Non-sensa
• Documentation of ACT Results• Documentation of urines• Timing urine dipsticks• Wrong level of QC creates outliers• Bad Patient/Operator ID’s• Timeliness of data (docking)
• CHANGE THE PROCESS
Reducing Medical Errors in POCT
Ohio POC
Operator Action Taxonomy from IEC 60601-1-6 and IEC Operator Action Taxonomy from IEC 60601-1-6 and IEC 6236662366
Reducing Medical Errors in POCT
Ohio POC
Reducing Medical Errors in POCT
Ohio POC
It is necessary to create a culture of change that embraces patient safety through shared accountability within a blameless culture.
Rosina Jones, LHRM, CHRM
Reducing Medical Errors in POCT
Ohio POC
AS/NZ 4360:1995 Risk Management AS/NZ 4360:1995 Risk Management OverviewOverview
Reducing Medical Errors in POCT
Ohio POC
Risk Assessment – Key ConceptRisk Assessment – Key Concept
Risk = Severity X Probability of Occurrence
Reducing Medical Errors in POCT
Ohio POC
Some common errors / Some common errors / misconceptions in doing human misconceptions in doing human factors risk analysisfactors risk analysis
• “If the operator does that, it is not our responsibility.”
• Vague description of the fault / use error (e.g. “operator error”, “programming error”, “sample mishandled”)
• Not documenting a fault/ hazard because the mode of control is assumed effective.
• Not documenting a fault/ hazard because: “no one will ever do that !”
• Not documenting a fault / hazard because “we would be liable if it happens (and we don’t have a mode of control for it)”
Reducing Medical Errors in POCT
Ohio POC
Become an auto-didactBecome an auto-didact
• FMEA• Six-Sigma• LEAN
• IHI.org
Reducing Medical Errors in POCT
Ohio POC
POC Critical Success FactorsPOC Critical Success Factors
• Standardize the process• Open communication• Clear understanding of regulations• Positive feedback for successes• Immediate corrective action• Access to information• Lockouts and forcing functions• PMA
Reducing Medical Errors in POCT
Ohio POC
Your mission…Your mission…• Be aware
Institute of Medicine Institute for Healthcare Improvement
• Risk Analysis Job functions Pre-analytical, analytical, post-analytical
What steps? List what could go wrong? (Risk Analyis) Prioritize (Severity)
• Improvement Ramps Plan, Do, Study, Act Change the process / re-educate Audit Retool
Reducing Medical Errors in POCT
Ohio POC
Questions?Questions?
Christopher FettersChristopher FettersAbbott Point of Care(781) 330-1113