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RECOMMENDATIONS2nd opinion for:Non-emergent cases for which Rxmet donebased on outside tissue or cytology dxdx.Second opinion done at treating institution.Cases of dx discrepancy with outsideinstitution need to be resolved beforedefinitive Rxmet.Cost Benefit of SecondReview Decrease elective surgery in 11-19%casesy medical Decrease unnecessaryprocedures i.e., angiography Saved 2-4 for every 1 spent (secondreview)Kronz et alCancer 86: 2426, 1999Second Review of ProstateBiopsies 1.3% bx’s reclassified as benign prior toradical prostatectomy Atrophy & adenosis msdx. Cancelled surgery in 6/535 cases Savings 1.91 for every 1 spent on 2ndreview Cost savings – IHC, repeat bx’s, ultrasound,surgeryEpstein et al.AJSP 20:851, 199614

Pathology ErrorsWall Street Journal “Growing evidence that patients shouldalways seek a 2nd opinion on lab work whencancer is suspected or dx” Johns Hopkins (1.4%)(1 4%)Dana Farber prostate dx (10%)Northwestern (8% of breast CA)etc. on 2nd review of outside pathologyTara Parker-PopeWSJ Feb 8, 200515

Errors in Surgical Pathology Review of malpractice claims from 2 timeperiods (1995-97 & 1998 – 2003) (DoctorsCompany) 1995-97 – 218 SP claims; 1998 – 2003 – 272claimsTroxel. AJSP 28:1092, 2004SP Claims – 1995-97 54% systematic cognitive errors – 52% ofthese false neg. dx, & 33% false positive False neg. breast FNA (sampling);melanoma misdx as Spitz nevi; failure todx lymphoma in extranodal sites; frozensection misdxTroxel. AJSP 28:1092, 200416

SP Claims – 1998 - 2003 61% false neg. dx, 27% false positive Melanoma false neg.; breast bx’s,misdx ovarian tumorstumors, operationalerrors, extranodal lymphomas, F.S.Errors – Patterns & Trends Melanoma misdx increased from 11 – 16%of total claims – misdx as Spitz,unrecognized desmoplastic, etc. Breast bx, breast FNA, FS – most commoncause off pathologyth lmalpracticelti claimsl i Extranodal lymphomas Less FNA claims PAP smears decreased from 17 – 11% oftotal claims Operational errors increased from 1.8 – 8%17

Melanoma Pitfalls Doctors Company malpractice claims 19952001 – 13% involved msdx of melanoma; 2ndmost common following breast. 70% false negative. Problems – “classic” melanoma dx as nevus,nevoid melanoma, desmoplastic melanoma,dysplastic nevus, and Spitz nevus. Shave or punch biopsies.Troxel DBAJSP 27:1278, 2003Spitz Nevus Spitz nevus in adult ( 20 y.o.) send toconsultant. All Spitz nevi should be completelyexcised (in young and adult).adult)Troxel – CAPMeeting at USCAPMarch 200318

Where AP Errors OccurPre-analytic Clinician – wrong information, noinformation, wrong specimen,inadequate or wrong sampling Specimen delivery Accessioning errors Histology errorsErrors in APAnalytic Gross Room – Poor gross examination –sampling, description, measurement,margins, sectioning, wrong studies orderedor proper studies omitted Frozen Section Microscopic Diagnostic: Cognitive mistakesin msdx or omitted dx. S.P. Report: Incorrect wording, typo’s,formattingAnalytic Error AnalysisSLIP- wrong action to achieve goal- unintended automatic action- misapplying known knowledgeLAPSES- inadvertent omission of automatic action- skipping a slide- mixing up casesKnowledge gapsPoor judgment19

COGNITIVE DIAGNOSTIC ERRORS(Acad. Med. Aug 03) Anchoring: Lock-in too early/fail to adjust to laterinformationConfirmation: Look for confirming evidence to supportDx /not looking for refutationDiagnosis Momentum: One Dx label attached becomesstickier and stickierAscertainment Bias: Thinking shaped by priorexpectations/stereotypingAvailability: If things rapidly come to mind/recentexperience-more likely to occurBase rate neglect: Ignore prevalence of a diseaseCommission bias: tendency toward actionOverconfidence: Universal tendency to believe weknow more than we do COGNITIVE ERRORS (CONT’D) Premature Closure: “when the diagnosis is made,the thinking stops”Fundamental Attribution Error: comorbid medicalconditions overlookedRepresentativeness Restraint: Looking forprototypical manifestations of disease; leads tomissing atypical variantsSearch Satisfying: Call off search once something isfoundSutton’s Slip: When possibilities other than theobvious are not given sufficient considerationSunk Costs: The more you invest in a Dx, less likelyto release it, and consider alternativesVertical Line Failure: Thinking in Silo’s: inflexible:what else could it be?CASE 2SP consultation slide from outsidehospital 68 yr. old male, stomach Bx.20

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Final DiagnosisBiopsy of stomach:- Invasive poorly differentiatedadenocarcinomaCASE 2 (continued)Patient then underwent resection ofstomach, spleen and tail of pancreasfor a 9.5 cm gastric mass22

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S100HMB45Melan AVimentinFinal Diagnosis--Metastatic malignant melanoma, invadinginto but not through the muscularis propriaof distal stomachEightg of nine lymphy p nodes positivepformetastatic malignant melanomaCASE 3 40 yr. old female, with history of leftbreast carcinoma, status-post radiationfollowing lumpectomy, underwentmastectomy24

Fat necrosis25

Final DiagnosisLeft breast mastectomy- Rare atypical glands, consistent withresidual ductal carcinoma, high nucleargrade- Extensive fat necrosisSMMH/P63Amended DiagnosisLeft Breast, mastectomy:- Rare atypical glands, consistent withradiation effect- ExtensiveE ti fatf t necrosisi26

CASE 4 81 yr. old male with history of bladdertumor underwent bladder neck andbladder biopsiesBladder neck tissue27

Bladder tissuePreliminary DiagnosisA. Left bladder neck tumor bx.:- invasive, moderately to poorlydifferentiated urothelial (transitionalcell) carcinoma with focal glandularmetaplasiat l iB. Bladder tissue:- Adenocarcinoma- Final diagnosis pendingimmunohistochemical studies28

ImmunostainsPSAP504SPAPCK20Amended DiagnosisA. Left Bladder neck tumor, Bx.:- Moderate to poorly differentiatedadenocarcinoma consistent withprostatic carcinomacarcinoma, Gleason scorescore,4 5:9B. Bladder tissue:- Prostatic adenocarcinoma GleasonScore 4 3:7CASE 5 50 yr. old female with history ofbilateral pneumothorax underwentedge resection of left upper andlower lobes29

Final DiagnosisA. Left lower lobe, wedge resection:- Emphysematous changes with blebformation- PleuralPll fibrosisfibi andd granulationl titissuetiB. Lt. upper lobe, tissue excision- Emphysematous bleb30

ImmunostainsSMAH-CaldesmomHMB-4531

Amended DiagnosisLymphangioleiomyomatosis oflungCASE 6 76 F with history of breast massunderwent rightg breast core bx32

Final DiagnosisRight breast core bx:- Invasive ductal carcinoma, NOS type,nuclear grade 3CASE 6 (continued) Patient then underwent core bx of 4.5cm left leg mass approximately 1 weeklater33

Preliminary Diagnosis Left leg soft tissue mass, touchpreparation and core Bx.:- PD malignacy- FinalFi l diagnosis,dii pendingdiimmunostainsit iS-100Melan-AAE1/3 Vimentin34

Final DiagnosisCore bx and left leg soft tissue mass- Poorly differentiated melanocyticmalignancylic.w. clearlcellll sarcoma(melanoma of soft parts)IHC then performed onbreast core bxS-100Melan AMITFAE1/335

Amended DiagnosisBreast bx: Metastatic malignantmelanocytic neoplasm c.w. metastaticmelanoma of soft partsCASE 7 7 y.o. male underwent cheek skin bxwhich was seen by pathologist /dermatopathologists36

DiagnosisSpitzp NevusCASE 7 (continued) Patient then underwent FNA ofparotid lymph node 1 1/2 years later37

Post-Analytic TATDeliveryCritical Value NotificationMisunderstood ReportClassification of Error in AP Henry Ford Hospital (2001-2003); 150,000 SPcases Amended report (2.3-3.3 amended reports/1,000cases) Pre-analytic – patient/tissue identified; grossdescriptions measurementsdescriptions,measurements, sampling (31-48%) Analytic – overcall/undercall; misclassified (2328%) Post-analytic – defective reports, typos,computer formatting errors (28-44%)Meier et al.Modern Pathol 185S:324A, 2005USCAP Abstract #150638

Surgeons Comprehensionof S.P. Report Questionnaires based on report given atsurgical conference with scoring ofattending physicians & trainees. SurgeonsSmisunderstoodid t d pathth reportt30% of the time. More experienced physicians did better.Powsner SM et al.Arch Pathol 124:1040, 2000Paul N. Valenstein, MD, Arch Pathol Lab Med. 132;84-94, 2008Challenge Converting data to useful information.Formatting the report.Grammar and word selection.Supporting text, comment, discussion.Ruby SGArchive Pathol 124:943, 2000(Editorial)39

Challenging Cases and NeedFor Effective Communication Dx should be based on accepted diagnosticcriteria, which should be stated in the report.Even if incorrect dx, written report may show“prudent,p, careful and informed” pathologist.pg Communicate differential dx. Recommend appropriate follow-up oradditional dx studies when appropriate. Document all verbal consultations withclinicians.Troxel. In J of SP 9:305, 2001Error IdentificationOpportunity to: Identify sources of systematic errors in SP Create strategies for eliminating errors Structure QA program to identify & correctrandom and systematic errors Improve the systemTroxel. AJSP 28:1092, 2004Error Prevention Build redundancyData collection to identify problemRoot cause analysisBenchmarkingDesign – simplification,standardization40

Error PreventionSystems approach:- Don’t consecutive accession same specimentypeput same typeyp of cases consecutivelyy in- Don’t ptray- Mandatory 2nd opinion on difficult/challengingtypes of cases- Eliminate or decrease distractions – phonecalls, physical plant improvement, etc.System Error Prevention(continued) Compare # of tissue fragments in block with #in slides. Block/slide correlation by 2nd histotech Gross description – dictate name or initials ofpatient. Don’t use “multiple” for gross # of fragments,unless 10. Bar-coding.JukicPCR 10:88, 2005Root Cause Analysis Root cause analysis helps identifywhat, how and why? Root causes are identifiable and allowfor generation of recommendationsrecommendations. The process involves data collection,cause charting, root causeidentification, recommendations andimplementation.41

Benchmarking Tools Q-Probes Proficiency testing (CAP PIP) Slide sets i.e., - California TumorR i tRegistry,etc.tSafety & Quality Q-Probes( 30 AP) Amended report (1997)Necessity of clinical information in S.P.S.P. specimen identification & accessioningFS/permanent section correlationFS TAT (1995)Routine biopsy TAT (1992, 1993)Complex S.P. TAT (1993)# of organ specific S.P. adequacy Q-ProbesAmended Reports 1.3/1000 S.P. reports amended 38.7% change final dx; 15.6% changepreliminary dx; 19.2% correct patientidentification errorserrors, 2626.5%5% - otherinformationCAP Q-probe of 3147/1,667,547 S.P.reports from 359 path departments;Arch Pathol 122:303, 199842

CAP Q-ProbeIdentification & AccessioningErrors 60,042/1,004, 115 cases (6%) Majority missing or inaccurate clinicalinfo Specimen identification (9.6%), faulty ormissing info (77%), specimen handling(3.6%)Nakhleh RE & Zarbo RJArch Pathol 120:227, 2996Quality ImprovementInitiative 1999 IOM report – wide rangingdisparities in quality of cancer care Improving quality of carecare, need highquality data High quality, reproducible data hasdecrease variationValue of Standardization andProtocol Use in Reporting Clinical utility - data/outcomeCompletenessAccurate – rules basedUniformityDecrease variation43

Pathology M & M1. Any case showing discrepancy betweenfrozen section and permanent diagnosis.2. Any case showing a discrepancy betweenpreliminary FNA and final diagnosis.3. Any case that has amended diagnosis withclinical significance.4. Any change in diagnosis, based on outsideconsultation.5. Any case showing significant discordancebetween cytology and surgical pathologydiagnosis.Silverman et al, Mod Path:1508, 200644

Pathology M & M (Continued)Any case having major intradepartmentaldifference of opinion based on internalconsultation, pathologists review forspecialty conference differing from primarypathologist of record, or 1 o’clock conferencedifferences, etc.A physicianAnyh i i complaintl i t concerningi a case.Any technical problems such as mislabeling,lost specimens, switch patient diagnosis, etc.Reporting issues.Terminology issuesStaging TNMSilverman et al, Mod Path:1508, 2006Impact of Monthly A&P Quality and SafetyConference in the Pathology Practice 18 month review, two time periods 0-9 mo.,9-18 mo. Improvement in incomplete examination,incorrect tumor classification/TNM staging.staging Total # of cases increased due toterminology/clerical problems. Most cases in follow-up were minordiscordance requiring no further action.Pereira, TC et al.Mod Pathol, 2006Critical Value Concept introduced by Lundberg (1972)– “pathophysiological derangement atsuch variance with normal as to be lifethreatening if therapy is not institutedimmediately” Standard of practice with wellestablished guidelines for clinicalpathology45

Critical Values (Clinical Path)ASCP practice Parameters (Guidelines) Generic critical values list derived from interlaboratory surveys – starting point Every lab must customize to meet the needs ofgtheir organization Strict semantic interpretation of critical limits Report by phone or alphanumeric page Initially Institutional Committee approve andperiodically review and reviseEmancipator K. AJCP 108:247, 1997 ASCP PracticeAssessment Committee & Board of DirectorsRepresentative ClinicalPathology Critical ValuesTestLow ValueHigh ValueCalcium 7 mg/dL 12 mg/dLGlucose 50 mg/dL 500 mg/dLPotassium 3.1 mmol/L 5.9 mmol/LSodium 121 mmol/L 159 mmol/LFibrinogen 50 mg/dLPT-INR 5.0Clinical LaboratoryImprovement Amendments of 1998(CLIA 88)Section 493.1109 (1) The laboratory must developand follow written procedures for reportingiimminentit life-threateninglif th t ilaboratoryl btresultslt orpanic values. In addition, the laboratory mustimmediately alert the individual or entity requestingthe test or the individual responsible for utilizingthe test results when any test results indicates animminent life-threatening condition.Lum G. Ann Clin Lab Sci. 28(5):261-71, 199846

JCAHO & C.V. JCAHO Standard LD 3.2.1: Approvedcriteria are established for theimmediate notification of theresponsible practitioner when criticallimits of specified test results areexceeded.JCAHO 2005National Patient Safety Goals Improve the accuracy of patient identification Improve the effectiveness of communication amongcaregivers. Measure, assess and, if appropriate,take action to improve the timeliness of reporting,andd theth timelinessti lioff receipti t byb responsibleibl licenselicaregiver, of critical test results and values Improve the safety of using medications Eliminate wrong-site, wrong-patient, wrongprocedure surgery Improve the effectiveness of clinical alarm systems Reduce the risk of health care-associated infections2007 NPSGsGoal 1Improve the accuracy of patient identification.1A Use at least two patient identifiers when providing care,treatment or services.1BPrior to the start of any invasive procedure, conduct afinal verification process (such as “time out,”) to confirmpatient,, procedurepand site usingg activethe correct pnot passive communication techniques.Goal 2 Improve the effectiveness or communication amongcaregivers.2AorderFor verbal or telephone orders or for telephonicreporting of critical test results, verify the completeorder or test result by having the person receiving theinformation record and “read back” the completeor test result.47

2007 NPSGs (cont)2BStandardize a list of abbreviations, acronyms,symbols, and dose designations that are not to be usedthroughout the organization.2CMeasure, assess and, if appropriate, take action toimprove the timeliness of reporting, and the timeliness ofimprove the timeliness of reportingreporting, and the timeliness ofreceipt by the responsible licensed caregiver, of criticaltestresults and values.2EImplement a standardized approach to “hand off”communications, including an opportunity to ask andrespond to questions.CAP & C.V. CAP Laboratory Accreditation Program– Laboratory General Checklist: Doesthe laboratory have procedures forimmediate notification of a physician when results of certain tests are withinestablished “critical” ranges?Critical Values in SurgicalPathology In Clinical Pathology there are wellestablished “critical values”– Very low or high serum potassium– Very low serum glucoseglucose There are established guidelines tocontact the clinician or nurse No guidelines in surgical pathology orliterature48

Anatomic Pathology The diagnosis are not measured innumbers However, certain diagnoses could requireimmediate treatment or evaluation of thepatient:– Crescents in kidney biopsy– Absence of villi or trophoblasts in uterinecontents– Organisms in immunocompromisedPrevalence and Perceptions ofCritical Values in AP Surgical Pathology – (0.49%) based onreview of 2,659 S.P. reports. Surveyed 11 pathologists (6) AGHAGH, 5national senior surgical and 5clinicians.Pereira, TC, Silverman, JFAJCP 122: 201, 2004Conclusions CV in SP are uncommon but not rare Majority of SP CV cases no documentation ofphone call HX often not provided Range of opinions among pathologists,pathologists &between pathologists & clinicians about needfor STAT phone call & degree of urgency Lack of consensus in identifying CV cases. No previous articles addressing CV in SPcases, although mentioned in texts (Rosai), orspecific cases (fat in endo bx in Mazur &Kurman)49

Prevalence of Cytology CV2000 cytology reports from AGH and Mayo Clinic – 200GYN,400 non-GYN, 400 FNA each institutionCV cases: Unexpected malignancy, disagreement betweenpreliminary FNA & final dx, orgs. in non-GYN & FNA52 CV (2.6%),(2 6%) including 0.25%0 25% (1/400) GYN,GYN 1.88%1 88% (15/800)non-GYN & 4.5% (36/800) FNAMost (42 cases) were unexpected malignancies, 5 disagreement, 5orgs.30/52 documented phone callPereira, TC, et al, Di Cy 34:447, 2006Recommendations Currently CV cases managed onpersonal experience & commonsense Some labs may have written policies,no established national guidelines Consensus conference of leaders inAP & key clinical specialists wouldbe useful to establish guidelinesAJCP 122:201, 2004Di Cy 34:447, 2006ADASP AP Critical ValueSurvey ResultsSurgical Pathology Survey 225 ADASP members for grading 17 possible S.

mandatory review, but ¾ of academic centers require it (AJSP 24:280, 2000) Mandatory Interinstitutional Pathology Consultation (IPCs) a.k.a. – Second Opinion ADASP recommend adoption of IPC