Michael Laposata, M.D., Ph.D. Director of Clinical Laboratories ...

Michael Laposata, M.D., Ph.D.Director of Clinical LaboratoriesMassachusetts General HospitalProfessor, Harvard Medical School

Has the right testbeen ordered?Error between resultreceipt and action?ActionOrderingInterpretationCollectionReportingIdentificationAnalysisTransportationPreparationThe nine steps in the performance of any laboratorytest. The brain-to-brain turnaround time loop.Lundberg, 1981

What points in the process have thehighest incidence of errors ?Test selection by clinicians ?Interpretation of test resultsby clinicians?YES

Medical Errors: Likelihood for recognitionError•Administration ofthe incorrect drugor incorrect dose of drug•Technical error in asurgical procedure•Incorrect or insufficientlaboratory tests ordered•Misinterpretation of laboratory testresult, leading to misdiagnosis orinappropriate/inadequate treatmentLikelihoodModerate - HighHighLowLow

Test related errors outside MGH – which laterpresented at MGH and were detected at that timeYoung father accused of shaking his baby –child had significant bleeding disordermissed by ordering clinician who mistakenlyinterpreted test results forvon Willebrands disease.Outcome-Father imprisoned, parents divorced

Test related errors outside MGH – which laterpresented at MGH and were detected at that time33 year old pregnant woman told she hassevere risk for thrombosis because of lowProtein S value. Clinician did not knowProtein S is lowered in most pregnancieswithout risk of thrombosis.Outcome - Woman terminates a normalpregnancy she desperately wanted to keep.

Increased cost ofcare from lab tests& technologist laborDelay in time to diagnosiswith increased length ofstay for inpatientsINCORRECT LABORATORY TESTS ORDEREDOR MISINTERPRETATION OF TEST RESULTSPhysician time lostin assessment ofincorrect testsClinical consequences andemotional distress fromunnecessary procedureor misdiagnosis

Changes in the Scope of Care Providedby Primary Care PhysiciansPhysicians’ Assessments of the Appropriatenessof Primary Care Physicians’ Scope of CareScope of CarePrimaryCarePhysicians(N=7015)N. Engl. J. Med, Dec. 23, 1999Specialists(N=5092)Greater than itshould be24 + 0.8 38 + 0.8

STRATEGY #1Use reflex testing asmuch as possible toincrease appropriatenessof test selection

1 Check in Box for Prolonged PTT PanelInitiates Use of This Test Selection AlgorithmProlonged PTT EvaluationDegrade heparin in sample and repeat PTT -if the PTT normalizes, heparin is the causePTT mixing study (1:1 mix ofpatient:normal plasma)PTT NormalizesPTT remains prolongedFactor deficiencymeasurefactors VIII, IX,XI, and XIIInhibitor, most commonly Lupus anticoagulant;may be a Factor VIII inhibitorif PTT mixing study first normalizes andthen becomes prolongedPerform tests for specific inhibitorssuggested by results of PTT mixing study

MGH experience with detectable errors in testselection by cliniciansTest selection errors by commerciallaboratory clients for hypercoagulablestatesThe clients were not given the opportunityfor reflex testing and forced to selectindividual tests from a large test menu

Percentage of Total Requistions4035302520151050Interpretations Reduce Test Ordering ErrorsFirst 3 monthsAfter 2 years ofinterpretationsNone One Two Three Four None One Two Three FourNumber of Errors Per Requistion

STRATEGY #2Provide patient-specific narrativeinterpretations of the test results,as done in Anatomic Pathology andRadiology, for complex evaluationsin many areas of Laboratory Medicine,obtaining clinical information whennecessary to enhance the speed andaccuracy of the interpretation.

THE LIST OF LABORATORY MEDICINEINTERPRETIVE ROUNDS AT THE MGHCurrently active-CoagulationAutoimmune diseaseHemoglobinopathy/AnemiaTransfusion reactions &Complex transfusion casesSerum protein analysisTo be activated-HepatitisTo be reactivated-ToxicologyNeeded but not created-Endocrinology

1996 Survey of MGH physician experience withnarrative interpretations of complex laboratoryevaluations in coagulationOrdering physicians sent a narrativeinterpretation of one their own casesClinicians asked to respond to severalquestions about the interpretation46 0f 100 surveys returned

THIS INTERPRETATION SHORTENEDTHE TIME TO A DIAGNOSIS ?6.5%34.8%58.7%YESNONO ANSWER

THIS INTERPRETATION PROBABLYREDUCED THE NUMBER OFLABORATORY TESTS REQUIRED TOMAKE A DIAGNOSIS ?26.1%2.2%71.7%YESNONO ANSWER

THIS INTERPRETATION HELPEDAVOID A MISDIAGNOSIS ?21.7%6.5%71.7%YESNONO ANSWER

DO YOU FIND THESEINTERPRETATIONS USEFULOR INFORMATIVE ?2.2%97.8%YESNO

2000 Survey of MGH physician experience withnarrative interpretations of complex laboratoryevaluations in coagulationOrdering physicians electronically sent anarrative interpretation of one their own casesClinicians asked to respond electronicallyto several questions about the interpretation100 of 100 surveys returned

Interpretation Impact - Physician OutcomesPercentage of Total Responses9080706050403020100Saved PhysicianTimeImpacted DifferentialDiagnosisReduced Time toDiagnosis

Interpretation ImpactMedical Utilization40Percentage of Total Responses3530252015105Reduced LabTestingReduced MedicalProceduresReducedAdmissionsReducedMedicationsReduced BloodProduct UsageReducedSpecialistConsultationIncreasedSpecialistConsultation0

Interpretation Impact - FinancialSavings per Year (Dollars)140000120000100000800006000040000200000OutpatientMedicalProceduresInpatient MedicalProceduresLab TestUtilizationBlood ProductUsage

CONSERVATIVE ESTIMATE OF SAVINGSFROM IMPLEMENTATION OF NARRATIVE REPORTYEAR# BILLED UNITS-ALL SERVICES# COAGINTERPS# COAG/ALL INTERPS199914189418028.2200016202508731.4200117710542330.6200220557516825.1

CONSERVATIVE ESTIMATE OF SAVINGSFROM IMPLEMENTATION OF NARRATIVE REPORTAverage % of billed units as coagulation interpretations:28.8 %Total quantifiable annual savings from coagulation service :$ 217,000Total quantifiable savings for all services by % of billable units :$ 753,472

REQUEST FOR IMPLEMENTATION OFPROGRAM TO REDUCE LABORATORY ERRORSFrom General Clinicians1. Make the service availableand easy to use2. Request for subspecialist cooperation3. Quality and efficiency are driving forces

BARRIERS TO IMPLEMENTATION OFPROGRAM TO REDUCE LABORATORY ERRORSFrom Pathologists1. Lack of expertise by pathologists2. Fear of subspecialist response3. No expectation of payment4. Complacency with canned comments5. Lack of interest by academic pathologists

BARRIERS TO IMPLEMENTATION OFPROGRAM TO REDUCE LABORATORY ERRORSFrom Administrators1. Cost of lab errors is not great2. Lack of trust regarding request tosupport a new service in pathology3. No expectation of payment or costsavings of magnitude

STRATEGY #3Create a national group ofexperts in the areas of LaboratoryMedicine to provide the narrativeinterpretations (A “Supreme Court”)and link the experts to the physiciansrequesting advice and theirpathologists through a web-basedInternet service

VIEWS OF PRACTICING PHYSICIANSAND THE PUBLIC ON MEDICAL ERRORS• Parallel national surveys of 831 practicingphysicians, who responded to mailedquestionnaires, and 1207 members of thepublic, who were interviewed by telephoneafter selection with the use of random-digitdialing.• Respondents asked about the causes of andsolutions to the problem of preventablemedical errors.N Engl J Med 2002; 347:1933-40

PERCEIVED CAUSES OFPREVENTABLE MEDICAL ERRORSPhysicians(N=831)Public(N=1207)P ValuepercentUnderstaffing of nurses in hospitals5365

Influence of HMOs and othermanaged-care plans ontreatment decisionsComplexity of medical carePERCEIVED CAUSES OFPREVENTABLE MEDICAL ERRORSPhysicians Public(N=831) (N=1207)percentInsufficient time spent by doctorswith patientsLack of computerized medicalrecords39383713N Engl J Med 2002; 347:193348627235P Value

POSSIBLE SOLUTIONS TO THE MEDICAL ERRORSRequiring hospitals to developsystems for preventing medicalerrorsIncreasing the number of nursesin hospitalsGiving physicians more time tospend with patientsPhysicians(N=831)555146percentPublic(N=1207)746978P Value

POSSIBLE SOLUTIONS TO THE MEDICAL ERRORSPhysicians(N=831)percentPublic(N=1207)P ValueLimiting certain high-riskprocedures to hospitals thatperform many proceduresImproving the training of healthprofessionals40364573