Management of the Management of the Cytology LaboratoryCytology Laboratory

Teresa Alasio, MDTeresa Alasio, MD

August 22, 2007August 22, 2007

The Players And The RulesThe Players And The Rules

The Players and the RulesThe Players and the Rules

Centers for Medicare and Medicaid Centers for Medicare and Medicaid Services (CMS)Services (CMS)– Division of HHSDivision of HHS– CMS regulates clinical laboratory testing on CMS regulates clinical laboratory testing on

humanshumans

CMS is charged with implementing CLIA CMS is charged with implementing CLIA 8888

CLIA 88CLIA 88

Clinical Laboratory Improvement Act of Clinical Laboratory Improvement Act of 19881988– Passed by CongressPassed by Congress– Establishes standards for all clinical Establishes standards for all clinical

laboratory testinglaboratory testing

WSJ article began media attention to false WSJ article began media attention to false negative pap tests*negative pap tests*– Poor quality cytology labs, too many cases Poor quality cytology labs, too many cases

screened, physician carelessnessscreened, physician carelessness*Bogdanich W. Physician's carelessness with Pap tests is cited in procedure's high failure rate. Wall Street Journal, December 29, 1987

Why is CLIA Important?Why is CLIA Important?

$$$$!$$$$!

To bill for and receive Medicare or Medicaid To bill for and receive Medicare or Medicaid payments, a clinical lab must have a CLIA payments, a clinical lab must have a CLIA certificatecertificate

For a cytology laboratory to receive a CLIA For a cytology laboratory to receive a CLIA certificate, it must be accredited by JCAHO or by certificate, it must be accredited by JCAHO or by CAPCAP– In Washington, Oregon and New York, a lab may In Washington, Oregon and New York, a lab may

obtain a state license in lieu of a CLIA certificateobtain a state license in lieu of a CLIA certificate

Why is CLIA Important?Why is CLIA Important?

Laboratory validationLaboratory validation

CLIA performs validation surveys on laboratoriesCLIA performs validation surveys on laboratories– Random surveys or those labs that have complaints Random surveys or those labs that have complaints

with CMSwith CMS

Evaluates all facets of the lab’s operations and Evaluates all facets of the lab’s operations and reviews at least 100 pap casesreviews at least 100 pap cases

Between 1998 and 2000, a total of 440 labs Between 1998 and 2000, a total of 440 labs surveyed, 12% had CLIA certificates revokedsurveyed, 12% had CLIA certificates revoked

Why is CLIA Important?Why is CLIA Important?

Proficiency Testing (PT) using a glass slide testProficiency Testing (PT) using a glass slide test

Mandated by CLIA 88, but no national program Mandated by CLIA 88, but no national program yet institutedyet instituted– Hotly debated topic, no one can agreeHotly debated topic, no one can agree

State PT programs in NY and Maryland use State PT programs in NY and Maryland use glass slidesglass slides– Maryland is only state meeting CLIA requirementsMaryland is only state meeting CLIA requirements

?Computer-based PT program?Computer-based PT program

More PlayersMore Players

Joint Commission on Accreditation of Joint Commission on Accreditation of Healthcare Organizations (JCAHO)Healthcare Organizations (JCAHO)– Hospitals surveyed q3yHospitals surveyed q3y– Laboratories surveyed q2yLaboratories surveyed q2y

CAP – inspects >6000 labs every yearCAP – inspects >6000 labs every year– Surveys performed q3ySurveys performed q3y

Still More PlayersStill More Players

Council for Accreditation of Allied Health Council for Accreditation of Allied Health Education Programs (CAAHEP)Education Programs (CAAHEP)– Accredits cytotechnology training programs in the US Accredits cytotechnology training programs in the US

upon recommendation of Cytotechnology Programs upon recommendation of Cytotechnology Programs Review Committee of the ASCReview Committee of the ASC

Occupational Safety and Health Administration Occupational Safety and Health Administration (OSHA)(OSHA)– Created in 1971Created in 1971– ““safety bill of rights”safety bill of rights”

Prevent injuries, illness and deaths on jobPrevent injuries, illness and deaths on job– OSHA Bloodborne Pathogens Standard and OSHA OSHA Bloodborne Pathogens Standard and OSHA

Laboratory Standard are relevant to Cyto labsLaboratory Standard are relevant to Cyto labs

The List Goes On…The List Goes On…

Health Insurance Portability and Accountability Health Insurance Portability and Accountability Act of 1996 (HIPAA)Act of 1996 (HIPAA)– Regulates protection of health care coverage for Regulates protection of health care coverage for

those who change jobsthose who change jobs– Regulates protection of privacy of medical informationRegulates protection of privacy of medical information

Individually identifiable health information (PHI)Individually identifiable health information (PHI)

National Fire Protection Association (NFPA)National Fire Protection Association (NFPA)– International non-profit organization founded in 1896International non-profit organization founded in 1896

>100 countries involved>100 countries involved

– Premier advocate for fire protection and safety codesPremier advocate for fire protection and safety codes

Who is in the Cyto Lab?Who is in the Cyto Lab?

Laboratory DirectorLaboratory Director

Responsibilities:Responsibilities:Overall operation and administration, including Overall operation and administration, including employment of personnelemployment of personnelMay also perform duties of the technical supervisor May also perform duties of the technical supervisor and general supervisorand general supervisor

QualificationsQualificationsLicensed to practice medicine or osteopathyLicensed to practice medicine or osteopathyAP certifiedAP certifiedMust possess a license as a laboratory director Must possess a license as a laboratory director issued by the state in which the laboratory is issued by the state in which the laboratory is located, if licensing is requiredlocated, if licensing is required

Technical SupervisorTechnical Supervisor

ResponsibilitiesResponsibilities– Establishing QC proceduresEstablishing QC procedures– Resolving technical proglemsResolving technical proglems– Evaluating competency of personnelEvaluating competency of personnel– Monitoring test resultsMonitoring test results– Performing semi-annual evaluations of CTsPerforming semi-annual evaluations of CTs– Establishing a workload limit for each CT and Establishing a workload limit for each CT and

reassessing it at least q6mreassessing it at least q6m

QualificationsQualifications– Licensed to practice medicine or osteopathyLicensed to practice medicine or osteopathy– AP certifiedAP certified

CytotechnologistCytotechnologist

ResponsibilitiesResponsibilities– Documenting slide interpretation resultsDocumenting slide interpretation results– Recording the number of slides examined each dayRecording the number of slides examined each day– Recording the number of hours worked each dayRecording the number of hours worked each day

Qualifications (at least 1 of the following)Qualifications (at least 1 of the following)– Graduated from a school of cytotechnology accredited Graduated from a school of cytotechnology accredited

by CAAHEPby CAAHEPBachelor’s degree needed Bachelor’s degree needed

– Certified in cytotechnology by an approved agency Certified in cytotechnology by an approved agency (ASCP)(ASCP)

““CT” and “SCT” certificates offeredCT” and “SCT” certificates offered– ““grandfathered” based on experience (prior to 1994)grandfathered” based on experience (prior to 1994)

Policies and ProceduresPolicies and Procedures

Policy and Procedure ManualsPolicy and Procedure Manuals

Two types of manuals to be maintainedTwo types of manuals to be maintained– Client service manual (CSM)Client service manual (CSM)– Laboratory procedure manual (LPM)Laboratory procedure manual (LPM)

Client Service ManualClient Service Manual

Written or electronic guide to providers on Written or electronic guide to providers on proper methods for obtaining, storing and proper methods for obtaining, storing and transporting specimens to the cyto labtransporting specimens to the cyto lab

Required policies in the CSM:Required policies in the CSM:– Preparation of patients (e.g. sputum, urine)Preparation of patients (e.g. sputum, urine)– Specimen collection (containers)Specimen collection (containers)– Specimen labeling Specimen labeling – Specimen preservation (fresh vs. fixed, refrigerated, Specimen preservation (fresh vs. fixed, refrigerated,

etc.)etc.)– Conditions for transportationConditions for transportation

Laboratory Procedure ManualLaboratory Procedure Manual

National Committee for Clinical Laboratory National Committee for Clinical Laboratory Standards (NCCLS) publishes a document Standards (NCCLS) publishes a document that outlines steps for preparing and that outlines steps for preparing and maintaining the manualmaintaining the manual– does not address many of specific policies does not address many of specific policies

and procedures of cytology laboratoriesand procedures of cytology laboratories

Laboratory Procedure ManualLaboratory Procedure Manual

Procedure manual must includeProcedure manual must include– Requirements for specimen collection and processingRequirements for specimen collection and processing– Criteria for specimen rejectionCriteria for specimen rejection– Procedures for microscopic examinationProcedures for microscopic examination– Step-by-step description of the performance of a Step-by-step description of the performance of a

procedureprocedure

Procedures must beProcedures must be– Approved, signed and dated by the directorApproved, signed and dated by the director– Re-approved, signed and dated if directorship Re-approved, signed and dated if directorship

changeschanges

Records of discontinued procedures must be Records of discontinued procedures must be kept for 2 yearskept for 2 years

WorkflowWorkflow

Specimen collection and transportationSpecimen collection and transportationAccessioningAccessioningSlide preparationSlide preparation– Separate staining of gyn and non-gyn Separate staining of gyn and non-gyn

Cross-contaminationCross-contamination

Slide examinationSlide examination– All cytology slides must be evaluated on the premises of a lab All cytology slides must be evaluated on the premises of a lab

certified for cytologic testingcertified for cytologic testing– Slides may not be taken home for evaluationSlides may not be taken home for evaluation

Reporting resultsReporting resultsRecord retentionRecord retention– reports: 10 yearsreports: 10 years– Slides: 5 yearsSlides: 5 years

RequisitionsRequisitions

Samples must be accompanied by a requisition Samples must be accompanied by a requisition formformRequisition form must includeRequisition form must include– Patient name or unique identifierPatient name or unique identifier– Name of person ordering test or submitting specimenName of person ordering test or submitting specimen– Test to be performedTest to be performed– Date of specimen collectionDate of specimen collection– For Pap tests: age/dob, LMP, history of abnl pap, rx For Pap tests: age/dob, LMP, history of abnl pap, rx

or bxor bx– Any additional information relevant and necessary to Any additional information relevant and necessary to

assure accuracyassure accuracy

Must be retained for at least 2 yearsMust be retained for at least 2 years

Federal Retention Requirements Federal Retention Requirements for Cytology Laboratoriesfor Cytology Laboratories

RequisitionsRequisitions– 2 years2 years

WorksheetsWorksheets– 2 years2 years

SlidesSlides– 5 years5 years– Includes gyn, non-gyn, normal and abnormalIncludes gyn, non-gyn, normal and abnormal

ReportsReports– 10 years10 years

Money IssuesMoney Issues

Billing and CodingBilling and Coding

One of the most difficult aspects of cyto One of the most difficult aspects of cyto lab managementlab management

Rules for filing claims to government Rules for filing claims to government agencies (Medicare, Medicaid and agencies (Medicare, Medicaid and TriCare) set standardTriCare) set standard– Private insurers and managed care Private insurers and managed care

companies may be differentcompanies may be different

Submitting Claims toSubmitting Claims toGovernment AgenciesGovernment Agencies

Laboratory must submit a claim that includesLaboratory must submit a claim that includes– Information such as date and location of serviceInformation such as date and location of service– ICD-9 codeICD-9 code

Justifying medical necessityJustifying medical necessity

Published by HHS, mandatory for Medicare claimsPublished by HHS, mandatory for Medicare claims

– Procedure code (CPT code)Procedure code (CPT code)Describing what was doneDescribing what was done

CPT codes published by the AMACPT codes published by the AMA

Uniform language to accurately describe medical, surgical Uniform language to accurately describe medical, surgical and diagnostic servicesand diagnostic services

How Payment is DeterminedHow Payment is Determined

Every CPT code has a $$ amount attached called a fee Every CPT code has a $$ amount attached called a fee schedulescheduleHow is that amount determined?How is that amount determined?Resource-Based Relative Value System (RBRVS) set by Resource-Based Relative Value System (RBRVS) set by MedicareMedicare– Compares the relative value of medical services across all Compares the relative value of medical services across all

specialty lines, based on work, practice expense and other specialty lines, based on work, practice expense and other factorsfactors

$$ value of a service or procedure is determined by its $$ value of a service or procedure is determined by its composite relative weight, multiplied by a nationally set composite relative weight, multiplied by a nationally set dollar conversion factordollar conversion factorConversion factors and RVUs are set by CMS and Conversion factors and RVUs are set by CMS and published annuallypublished annuallyPayment(code) = RVU x Conversion FactorPayment(code) = RVU x Conversion Factor

Specific Tests and CodesSpecific Tests and Codes

Coding Pap TestsCoding Pap Tests

Paps are divided into 3 types for Medicare beneficiariesPaps are divided into 3 types for Medicare beneficiaries– Implications for payment to lab by MedicareImplications for payment to lab by Medicare

Screening Paps:Screening Paps:– No more than 1 test per 24 months is coveredNo more than 1 test per 24 months is covered

Screening, high risk: Screening, high risk: – No more than 1 test per 11 months coveredNo more than 1 test per 11 months covered

Diagnostic paps:Diagnostic paps:– Unlimited coverageUnlimited coverage

Only referring physician can classify paps as screening, Only referring physician can classify paps as screening, high risk or diagnostichigh risk or diagnostic– ““code jamming” – when a laboratory unilaterally classifies or code jamming” – when a laboratory unilaterally classifies or

reassigns codes – illegal activity!reassigns codes – illegal activity!

Screening Pap - RoutineScreening Pap - Routine

No current sign, symptom or complaint referable to the cervixNo current sign, symptom or complaint referable to the cervixNo previous abnormal papNo previous abnormal papNo high-risk factors for cervical cancerNo high-risk factors for cervical cancerICD-9 code is V76.2ICD-9 code is V76.2

If screening pap comes back abnormal, case receives an extra ICD-If screening pap comes back abnormal, case receives an extra ICD-9 code for atypia and patient moves to high-risk category so that 9 code for atypia and patient moves to high-risk category so that Medicare will pay for more frequent papMedicare will pay for more frequent pap– Clinician must provide extra code, or else lab can be in trouble for Clinician must provide extra code, or else lab can be in trouble for

adding a “false claim” and being fraudulent!adding a “false claim” and being fraudulent!ABN – advance beneficiary noticeABN – advance beneficiary notice– Signed by patient to authorize lab to bill pt directly if service not covered Signed by patient to authorize lab to bill pt directly if service not covered

by Medicareby Medicare– Usually obtained and retained by clinician’s officeUsually obtained and retained by clinician’s office

Screening, High-risk PapScreening, High-risk Pap

Early onset of sexual activity (<16 years)Early onset of sexual activity (<16 years)

Multiple sex partners (>5/lifetime)Multiple sex partners (>5/lifetime)

History of STDs, including HIVHistory of STDs, including HIV

<3 negative paps in previous 7 years<3 negative paps in previous 7 years

Daughter of DES motherDaughter of DES mother

Abnormal pap in past 3 years (childbearing age Abnormal pap in past 3 years (childbearing age women only)women only)

ICD-9 code is V15.89 or V69.2 (early sexual ICD-9 code is V15.89 or V69.2 (early sexual activity)activity)

Diagnostic Pap TestDiagnostic Pap Test

Previously diagnosed cancer of vagina, cervix or uterusPreviously diagnosed cancer of vagina, cervix or uterusPrevious abnormal papPrevious abnormal papCurrent abnormal findings of vagina, cervix, uterus, Current abnormal findings of vagina, cervix, uterus, ovaries or adnexaeovaries or adnexaeSignificant complaint referable to the female repro Significant complaint referable to the female repro systemsystemAny sign or symptom that might be related to a gyn Any sign or symptom that might be related to a gyn disorderdisorderCommonly accepted ICD-9 Codes: 622.1 (dysplasia of Commonly accepted ICD-9 Codes: 622.1 (dysplasia of cervix, 795 (f/u to previous abn pap)cervix, 795 (f/u to previous abn pap)

Diagnostic pap test is covered by Medicare regardless of Diagnostic pap test is covered by Medicare regardless of whether or not it is abnormalwhether or not it is abnormal

Coding Non-gyn, Non-FNA casesCoding Non-gyn, Non-FNA cases

Every separate specimen receives its own billing codesEvery separate specimen receives its own billing codesNo bundling (e.g. direct smears, thinlayer smears and No bundling (e.g. direct smears, thinlayer smears and cell block slides are distinct preparations and are cell block slides are distinct preparations and are separately coded per specimenseparately coded per specimen– Right/left pleural fluids billed separately, bronchial washings and Right/left pleural fluids billed separately, bronchial washings and

brushings billed separatelybrushings billed separately

Charge codes based on preparation methodCharge codes based on preparation method– Direct smears, thinlayers, cell blocks, special stains, IHC, etc.Direct smears, thinlayers, cell blocks, special stains, IHC, etc.

““Extended cytology study” applies to cases:Extended cytology study” applies to cases:– Where there are >5 slides of same type, except cell blocksWhere there are >5 slides of same type, except cell blocks– Multiple routine stains are performed on preparations of same Multiple routine stains are performed on preparations of same

type, e.g. paps and diff-quiks on smearstype, e.g. paps and diff-quiks on smears

Coding FNAsCoding FNAs

Extraction code – 10021 Extraction code – 10021 – Fundamental unit is the specimen not the “pass”Fundamental unit is the specimen not the “pass”– Multiple passes, same anatomic site vs. separate anatomic sites Multiple passes, same anatomic site vs. separate anatomic sites

(separate extraction charge for each site)(separate extraction charge for each site)– Ok to bill if resident or fellow does FNA as long as senior Ok to bill if resident or fellow does FNA as long as senior

pathologist supervises procedurepathologist supervises procedure

Adequacy assessments – 88172Adequacy assessments – 88172– Can be performed by pathologist or techCan be performed by pathologist or tech– Applies even if clinician performs procedureApplies even if clinician performs procedure

FNA diagnosis code – 88173FNA diagnosis code – 88173– When final report is signed outWhen final report is signed out

Never apply “extended cytology study” code, no matter Never apply “extended cytology study” code, no matter how many slides there arehow many slides there areCan charge for stains and IHC, as well as CBCan charge for stains and IHC, as well as CB

Quality Control and Quality Control and Quality AssuranceQuality Assurance

False Negatives/False-PositivesFalse Negatives/False-Positives

Sampling errorSampling error– DeviceDevice– Insufficient transferInsufficient transfer

Laboratory errorLaboratory errorscreeningscreeningInterpretationInterpretation

QC standards set by CLIA 88 seeks to QC standards set by CLIA 88 seeks to minimize laboratory component of errorsminimize laboratory component of errorsSlide re-examinationSlide re-examination

Slide Re-examinationSlide Re-examination

Prospective screening of 10% of negative Prospective screening of 10% of negative cases (10% rescreen)cases (10% rescreen)

Retrospective review of all negative Paps Retrospective review of all negative Paps from women with newly diagnosed HSIL from women with newly diagnosed HSIL (5-year lookback)(5-year lookback)

Review of discrepancies between Pap and Review of discrepancies between Pap and biopsy results (cyto/histo correlation)biopsy results (cyto/histo correlation)

10% Rescreen10% Rescreen

All labs in the US are required to rescreen All labs in the US are required to rescreen at least 10% of negative Papsat least 10% of negative Paps– Randomly selectedRandomly selected– Targets high-risk patients with h/o SILsTargets high-risk patients with h/o SILs

ProspectiveProspective

Checks CTs work before case report is Checks CTs work before case report is issuedissued

5-Year Lookback5-Year Lookback

Retrospective rescreening patients with Retrospective rescreening patients with newly diagnosed HSIL, ACA or malignant newly diagnosed HSIL, ACA or malignant neoplasm whose earlier Paps were neoplasm whose earlier Paps were negativenegativeLikelihood of detecting error is greater Likelihood of detecting error is greater than with prospective screeningthan with prospective screening– More intense rescreeningMore intense rescreening– Estimated frequency of errors may be inflated Estimated frequency of errors may be inflated

because HSIL is knownbecause HSIL is known

Cytology/Histology CorrelationCytology/Histology Correlation

Not all abnormal Pap results are confirmed Not all abnormal Pap results are confirmed by colposcopy and biopsy.by colposcopy and biopsy.

Positive predictive value of Pap test is Positive predictive value of Pap test is <100% and related to the degree of <100% and related to the degree of abnormalityabnormality– For ASC, PPV is 58-62% for having SILFor ASC, PPV is 58-62% for having SIL– If LSIL, PPV is 50-86% for having a lesionIf LSIL, PPV is 50-86% for having a lesion

12-17% of cases high grade lesion is discovered12-17% of cases high grade lesion is discovered

Reasons for DiscrepancyReasons for Discrepancy

Frequency of discrepancy between Pap and Frequency of discrepancy between Pap and biopsy ranges from 11-32%biopsy ranges from 11-32%Discordance in grade accounts for Discordance in grade accounts for approximately 43% of discrepant diagnosesapproximately 43% of discrepant diagnosesReasons for discrepancy:Reasons for discrepancy:– Lesion not detected colposcopicallyLesion not detected colposcopically– Biopsy not properly embeddedBiopsy not properly embedded– Lesion undetected or misinterpreted when biopsy first Lesion undetected or misinterpreted when biopsy first

examinedexamined

Rarely, a lesion is overcalled on PapRarely, a lesion is overcalled on Pap

Discrepancy ReviewDiscrepancy Review

CLIA requires that all Paps reported as CLIA requires that all Paps reported as HSIL, ACA or other malignant neoplasms HSIL, ACA or other malignant neoplasms must be correlated with subsequent must be correlated with subsequent histopathologic reportshistopathologic reports

StatisticsStatistics

CLIA 88 regulations require that cytology laboratories CLIA 88 regulations require that cytology laboratories compile annual statisticscompile annual statisticsMust document:Must document:– Number of cytology cases examinedNumber of cytology cases examined– Number of specimens by specimen type (sputum, urine, etc.)Number of specimens by specimen type (sputum, urine, etc.)– Volume of cases by diagnosis (negative, atypical, suspicious, Volume of cases by diagnosis (negative, atypical, suspicious,

positive)positive)– Number of unsat casesNumber of unsat cases– Number of Pap tests with discrepant histology resultsNumber of Pap tests with discrepant histology results– Number of negative Pap tests reclassified as abnormalNumber of negative Pap tests reclassified as abnormal– Number of Paps reported as HSIL, ACA or malignant neoplasm Number of Paps reported as HSIL, ACA or malignant neoplasm

with no histologic follow-upwith no histologic follow-up

Workload RecordsWorkload Records

CLIA 88 regulations establish workload limits for CLIA 88 regulations establish workload limits for CTs in the USCTs in the USMaximum number of slides is 100 per 24 hour Maximum number of slides is 100 per 24 hour periodperiod– NY = 80 maxNY = 80 max– Maximum amount allowable by lawMaximum amount allowable by law

12.5 slides/hr = 8 hour screening12.5 slides/hr = 8 hour screeningCT is responsible for keeping records of total CT is responsible for keeping records of total slides examined/dayslides examined/day– If CT works different labs, then number is cumulativeIf CT works different labs, then number is cumulative

LIS also keeps documentation of workload limitsLIS also keeps documentation of workload limits

Not all slides are created equal:Not all slides are created equal:Half slidesHalf slides

Cytocentrifuge preparationsCytocentrifuge preparations

Cell block sectionsCell block sections

ThinPrep slidesThinPrep slides

SurePath slidesSurePath slides

Applies only to non-gyn casesApplies only to non-gyn cases

Performance EvaulationPerformance Evaulation

Assessment of CompetancyAssessment of Competancy

Glass slide proficiency testsGlass slide proficiency tests– CAPCAP– ASCPASCP– Midwest Institute for Medical Education (MIME)Midwest Institute for Medical Education (MIME)

Measures of CT performanceMeasures of CT performance– ScreeningScreening– interpretationinterpretation

Measurement of Cytopathologist performanceMeasurement of Cytopathologist performance

Rationale for Objective Measures Rationale for Objective Measures of Performanceof Performance

Reinforce subjective impressionsReinforce subjective impressions

Rectify misperceptionsRectify misperceptions

Carry more weight with regulatory Carry more weight with regulatory agenciesagencies

May be more acceptable to employee than May be more acceptable to employee than subjective measures as justification for subjective measures as justification for educational enhancementeducational enhancement

CT - Assessment of Screening CT - Assessment of Screening SkillsSkills

False-negativesFalse-negatives– 10% rescreen helps to identify CTs performance10% rescreen helps to identify CTs performance

False negative rate (FNR)False negative rate (FNR)– FNR = FN/(TP+FN)FNR = FN/(TP+FN)– Can be calculated for individual CTsCan be calculated for individual CTs– Thresholds must be setThresholds must be set

Abnormal rateAbnormal rate– %age of abnormal cases (ASC and above) diagnosed by CT divided by %age of abnormal cases (ASC and above) diagnosed by CT divided by

total number of cases examinedtotal number of cases examined– Useful for performance evaluation because it allows comparison with Useful for performance evaluation because it allows comparison with

laboratory averagelaboratory averageUse Z score, standard normal deviateUse Z score, standard normal deviateZ score >2.0 shows abnormal rate more than two SD above averageZ score >2.0 shows abnormal rate more than two SD above averageLower than avg means lesions are being missed (Z score less than -2.0)Lower than avg means lesions are being missed (Z score less than -2.0)Double check against FNRDouble check against FNR

CT – Assessment of CT – Assessment of Interpretive Skills Interpretive Skills

CT/CP discrepancy logCT/CP discrepancy log– Concordance between CT and CPConcordance between CT and CP– Kappa value is statistical measure of degree of Kappa value is statistical measure of degree of

concordance between two observersconcordance between two observersRange is between 0 and 1.0, where 0 means chance Range is between 0 and 1.0, where 0 means chance agreement and 1.0 means perfect concordanceagreement and 1.0 means perfect concordance

Unsatisfactory rate (UR)Unsatisfactory rate (UR)– Low UR means that insufficiently stringent adequacy Low UR means that insufficiently stringent adequacy

criteria are being appliedcriteria are being applied– Z score is used here as well to determine deviation Z score is used here as well to determine deviation

from laboratory averagefrom laboratory average

Measurement of Measurement of Cytopathologist PerformanceCytopathologist Performance

ASC/SIL ratioASC/SIL ratio– Ratio should not exceed 3:1, because Ratio should not exceed 3:1, because

excessively high ratio means CP is unsure of excessively high ratio means CP is unsure of diagnosisdiagnosis

Cytology/biopsy correlationCytology/biopsy correlation

PPV = TP/(TP+FP)PPV = TP/(TP+FP)– When CP makes a diagnosis, how often is it confirmed by When CP makes a diagnosis, how often is it confirmed by

subsequent biopsy?subsequent biopsy?– Define positive diagnosis – atypical, suspicious, positive?Define positive diagnosis – atypical, suspicious, positive?

Specificity = TN/(TN+FP)Specificity = TN/(TN+FP)More difficult to apply, because negative dx more difficult to verifyMore difficult to apply, because negative dx more difficult to verify

Sensitivity = TP/(TP+FN)Sensitivity = TP/(TP+FN)

PPV and Specificity relate to false positives (overcalls)PPV and Specificity relate to false positives (overcalls)

Sensitivity relates to false negatives (undercalls)Sensitivity relates to false negatives (undercalls)

Likelihood RatioLikelihood Ratio

Specificity and sensitivity are negatively Specificity and sensitivity are negatively correlated and can be expressed simultaneously correlated and can be expressed simultaneously in a Likelihood Ratio (LR)in a Likelihood Ratio (LR)– Probability of a given test result of disease is present Probability of a given test result of disease is present

divided by probability of same result if disease is divided by probability of same result if disease is absentabsent

LR= sensitivity/(1-specificity)LR= sensitivity/(1-specificity)

Receiver Operating Characteristic (ROC) curves Receiver Operating Characteristic (ROC) curves can be generated for individual pathologists to can be generated for individual pathologists to evaluate diagnostic accuracy evaluate diagnostic accuracy

Laboratory SafetyLaboratory Safety

OSHA Bloodborne Pathogens StandardOSHA Bloodborne Pathogens Standard– Exposure to blood and potentially infectious body Exposure to blood and potentially infectious body

fluids (handwashing, PPE, etc.)fluids (handwashing, PPE, etc.)

OSHA Laboratory StandardOSHA Laboratory Standard– Occupational exposures to hazardous chemicalsOccupational exposures to hazardous chemicals– Permissible exposure limits (PEL)Permissible exposure limits (PEL)

NFPA Standard for Health Care FacilitiesNFPA Standard for Health Care Facilities– Requirements for minimizing hazards in laboratories Requirements for minimizing hazards in laboratories

due to firedue to fire

Thank you!Thank you!