3ObjectivesUnderstand Medical Errors RatesReview Case StudiesCreate AwarenessShare experiencesInspire you to further research and learningNot here to teach you how to perform an FMEA, Fault Trees, or Risk Analysis
5To Err is Human - Building a Safer Health System A Report From The National Academies of Science, Institute of Medicine44,000 – 98,000 patients killed each year by preventable medical mistakesKey RecommendationsFocus greater attention on patient safetyCenter for patient safetyNational mandatory reportingPeer review protectionsFDA should increase attention to safe use of drugs
6Principle 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.
7Nurse training Right Patient Right Drug Right Dose Right Route Right Time770,000 untoward drug errors
8It is not the strongest of the species that survives, not the most intelligent, but the one most responsive to change.Charles Darwin
9Causes of Medical Mistakes 15-20% is mechanical failure60-80% is human errorActive errorsLatent errors
10Goal Goal in Point of Care? Goal in the Laboratory? Goal in the Hospital?Golden Rule: Do unto others as you wouldhave them do unto your mother.
11IDIOT Not this one It can be simple “er” – Season finale Romano’s accidentNot this oneIDIOT
12Three phases of laboratory testing Pre-analyticalAnalyticalPost-analytical
13hile 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.”WGerald J. Kost, MD, PhD. “Using operator lockout to improve the performance of point-of-care blood glucose monitoring.”
1482% of Patient Data Still Manually Recorded Source: 1999 EAC US Hospital POC Survey
15Tighter Control =Higher Quality =Improved Safety =Better Patient Care !!
16Is 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 misspelled114,500 mismatched pairs of shoes will be shipped/year811,000 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 strips2,488,200 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/hour22,000 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 yearYour 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
17Healthcare Personnel Shortages Other HospitalProfessions25%Registered Nurses75%As many as 168,000 hospital positions are unfilled in six selected job categories. Three out of four vacancies are nursing positionsNote: Other hospital professions include pharmacists, radiological technologists, laboratory technologists, billing/coders, and housekeeping/maintenance staff.
18Harrisburg Sunday Patriot-News, September 9, 2001.
19Three approaches to quality RemedialAlleviate the symptoms of the existing problemCorrectiveEliminate the cause of existing problems or undesirable situation to prevent recurrencePreventiveEliminate the cause of potential problems
20Improving performance without changing the process is not process improvement,it’s performance improvement.Tony Joseph
21Quality Principles Respect human limits in process design Avoid reliance on memoryUse constraints and forcing functions (eg, lockouts)Simplify and standardize the work processAnticipate the unexpectedAdopt a proactive approachDesign for recoveryImprove access to accurate, timely informationCreate a learning environment
22Use 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)FDA distinguishes between 2 kinds of errors.
23Use Error Examples from IEC 62366 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.Discuss these use error examples. Note that they are foreseeable and therefore predictable.
24Abnormal Use Examples from IEC 62366 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.Discuss:Examples of Abnormal Use
25Point of Care Errors MD Pocket Developer Documentation of ACT Results Distilled WaterSensa v. Non-sensaDocumentation of ACT ResultsDocumentation of urinesTiming urine dipsticksWrong level of QC creates outliersBad Patient/Operator ID’sTimeliness of data (docking)CHANGE THE PROCESS
26Operator Action Taxonomy from IEC 60601-1-6 and IEC 62366 Discuss what is below and above the dotted line which represents manufacturers responsibility.
30Risk Assessment – Key Concept Risk = Severity X Probability of Occurrence
31Some common errors / misconceptions in doing human factors 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)”Here are some common misconceptions / mistakes people make when dealing with human error.If a forseeable use error, it is the manufacturers responsibility.If too general, mitigations cannot be credibly applied to fixing the problem, and you are likely to overlook real hazards.Should strive to document all use error problems including those already taken care of. You should take credit for your designs.Should strive to document all use error problems including those with low probability.May be true, but if it is not addressed because of this fear, negligence can be another charge added. Also if not listed, there is much less a chance of ever addressing or mitigating the problem.
33POC Critical Success Factors Standardize the processOpen communicationClear understanding of regulationsPositive feedback for successesImmediate corrective actionAccess to informationLockouts and forcing functionsPMA
34Your mission… Be aware Risk Analysis Improvement Ramps Institute of MedicineInstitute for Healthcare ImprovementRisk AnalysisJob functionsPre-analytical, analytical, post-analyticalWhat steps?List what could go wrong? (Risk Analyis)Prioritize (Severity)Improvement RampsPlan, Do, Study, ActChange the process / re-educateAuditRetool
35Questions? Christopher Fetters Abbott Point of Care (781) 330-1113