insightsmarch/april — 2014newsletter.cola.org/2014/april/insights.pdf · 2014. 12. 23. ·...

INTO

Laboratory Director Responsibilities

C O L A ’ S

M A R C H / A P R I L — 2 0 1 4

inSights

A L S O I N T H I S I S S U E :LetterfromtheChair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

LDROverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

LDR1E-DoestheLaboratoryDirectormeettheGeneralResponsibilitiesoftheposition? . . . . . . . 4

LDR2E-DoestheLaboratoryDirectormeettheProceduralResponsibilitiesoftheposition? . . . 6

LDR3E-DoestheLaboratoryDirectormeetthePersonnelManagementResponsibilitiesoftheposition? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

LDR4E-DoestheLaboratoryDirectormeettheProficiencyTestingResponsibilitiesoftheposition? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

LDR5E-DoestheLaboratoryDirectormeettheQualityControlandQualityAssessmentResponsibilitiesoftheposition? . . . . . . . . . . . . . . . . . . . .16

LDR6R-LaboratoryDirectorContinuingEducationProgram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

TechnialBulletin-LDR6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

LDRSupportChart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

inSightsSPOTLIGHT:LaboratoryExcellenceAward . . . . . . . . . . . . . . . . . . . . . . .25

COLA&CRISaluteMedicalLaboratoryProfessionalsWeek! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

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C O L A’ S inSights M A R C H / A P R I L - 2 0 1 42

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FROM THE CHAIRWelcome to COLA’s March/April issue of Insights!

In this issue of COLA inSights we take an objective look at the Laboratory Director

Responsibilities as they relate to COLA Accreditation . The Laboratory Director

Responsibilities(LDR)CriteriaareintendedtogiveLD’stheclearcutinstructionneeded

tobeaneffectiveleaderofthelaboratory .

TheCOLAAccreditationManualitstatesthat“The Laboratory Director is responsible for

the overall operation and administration of the laboratory, and for assuring compliance

with all applicable regulations. The Laboratory Director must meet education and

experience requirements to hold the position, and must meet all of the responsibilities

associated with the position, including ensuring that there are sufficient personnel with

adequate experience and training to conduct the work of the laboratory. He or she must

also ensure that every position in the laboratory is filled by an individual qualified to hold

the position and able to perform the tasks required of the position.”

ThisissueofinSightswilllookateachoftheLaboratoryDirectorResponsibilitycriteria .

LDR 1 E-Does the Laboratory Director meet the General Responsibilities of the position?

LDR 2 E - Does the Laboratory Director meet the Procedural Responsibilities of the

position? LDR 3 E - Does the Laboratory Director meet the Personnel Management

Responsibilities of the position? LDR 4 E - Does the Laboratory Director meet the

Proficiency Testing Responsibilities of the position? LDR 5 E-Does the Laboratory Director

meet the Quality Control and Quality Assessment Responsibilities of the position? And

thenewestcriteriaLDR 6R-Has the Laboratory Director completed, within the last two

years, four continuing education credits (CME or PACE) from the COLA Laboratory Director

Continuing Education Program (LDCEP), or other equivalent laboratory director education

program?

“COLA standards were developed by physicians, clinical laboratory scientists, and other

clinical laboratory professionals. They are based on proven clinical laboratory standards

and accepted good laboratory practices. These standards reflect requirements for

procedures that are performed in the laboratory environment and are necessary for any

laboratory to produce consistently accurate results. COLA standards have been deemed

to be equivalent to the federal CLIA regulations.”-2013COLAAccreditationManual

In addition, we are excited to announce a new feature in COLA inSights: inSights

SPOTLIGHT: LABORATORY EXCELLENCE AWARD . Beginning with this issue and in all

futureissueswewillhighlightaCOLAAccreditedlaboratorythathasbeenawardedthe

Laboratory Excellence (LEA) Award, or has demonstrated exemplary performance in

laboratorymedicine .Wehopethisacknowledgementinspiresallofourlaboratoriesto

pursueExcellenceinLaboratoryMedicine!

AstheLaboratoryDirectorthereismuchrequiredintermsofnotonlytechnicalexpertise

but communication, education and leadership . Laboratory Directorship is sometimes

challengedwithemployeeturnover,limitedbudgets,andantiquatedequipment .Some

laboratoriesarestateoftheart,fullystaffedandhaveunlimitedbudgetsforeverything

fromeducationtoconsumables .ButastheLabDirectorineitherscenarioyoufindaway

foryourstafftoprovidequalitytestresultsthatdirectlyaffectpatientcare .Weinviteyou

to share this issue of inSights with your staff and colleagues to learn and share the

requirementsofaLaboratoryDirectorandcollaboratetoensuresuccessinthelaboratory .

Richard A. Wherry, M.D. Chair, COLA Board of Director

COLA Technical Assistance 800.981.9883 | www.cola.org | www.LabUniversity.org | www.COLAcentral.com 3

Oneofthemainquestionspeopleaskwhenthinkingoflaboratoriesandtheiraccreditation/certificationis“Whoisincharge?”Thisquestionraisesmanykeyconcernsabouthowthelaboratoryisbeingmanaged,whodelegatestherolesandresponsibilitiesofthepersonnel,andmostimportantly,whoisultimatelyresponsibleforeachtestresultproducedfromthelaboratory .ManylaboratoriansseetheroleoftheLaboratoryDirector(LD)asglamorousbecausetheyoverseetheentirelaboratory,butinactualityitisagreatresponsibilitythatmustbeenteredintocautiously .

Theamountoftime,energyandresourcesmustbecarefullyconsideredwhentakingaLaboratoryDirectorship .Thesetasksbecomelessdauntingwhenthereisasincereplanofactionfortimemanagementandeffectivecommunication .ThisissueofinSightsonLaboratoryDirectorResponsibilitieswillprovidemuchneededdiscussionaboutthedutiesoftheLDandhowtoensurecompliancewithCOLAAccreditation .FailuretofulfilltheLDRcriteriaisamajorcauseofunsuccessfulsurveys .

Thelaboratorymustbeunderthedirectionofaqualifiedindividual,andthatindividualmustfulfillalltheresponsibilitiesoftheLaboratoryDirectorasoutlinedbyCLIAandCOLA .CLIAprohibitsaLaboratoryDirectorfromdirectingmorethanfivenon-waivedlaboratories .SomestateshavefurtherrestrictionsregardingthenumberoflabsthatanLDcandirect .TheLaboratoryDirectorisresponsiblefortheoveralloperationandadministrationofthelaboratory,andforassuringcompliancewithallapplicableregulations .TheLaboratoryDirectormustmeeteducationandexperiencerequirements(seePERevaluationgrouping)toholdtheposition,andmustmeetalloftheresponsibilitiesassociatedwiththeposition,includingensuringthattherearesufficientpersonnelwithadequateexperienceandtrainingtoconducttheworkofthelaboratory .Heorshemust

alsoensurethateverypositioninthelaboratoryisfilledbyanindividualqualifiedtoholdthepositionandabletoperformthetasksrequiredoftheposition .

TherequirementforthelaboratorytobeunderthedirectionofaqualifiedindividualisnotautomaticallymetsimplybecausethedirectormeetstheeducationandexperiencerequirementsdescribedinthePERevaluationgrouping .Theindividualmustalsodemonstratethatheorsheisprovidingeffectivedirectionovertheoperationofthelaboratory .Whendeterminingwhetherthedirectorresponsibilitiesarebeingmet,thesurveyorwillconsiderdeficienciesfoundinotherareas,suchasfacilityadministration;proficiencytesting;andgeneral,pre-analytic,analytic,andpost-analyticsystems .

SomeresponsibilitiesoftheLabDirectormaybedelegatedtoaqualifiedindividual .However,itremainstheresponsibilityoftheLabDirectortoensurethatalldelegateddutiesareproperlyperformed .BeitaTechnicalSupervisor,TechnicalConsultantorGeneralSupervisor,theLDmustensurethatwhatevertasksaredelegatedtotheseindividualsareperformedproperlyandincompliancewithallnecessaryregulations .Ifqualified,theLaboratoryDirectormayholdotherrequiredpositionsinthelaboratory .Ifso,heorshemustalsomeetthoseresponsibilities .TakethetimetoreviewthisissueofinSightsfortrueclarificationandhelpfultipstohelpLaboratoryDirectorsensureExcellenceinLaboratoryMedicine!

LDR Overview


LAB DIRECTOR RESPONSIBILITIES LDR 1 E Does the Laboratory Director meet the General Responsibilities of the position?

Theday-to-dayactivitiesoftheLaboratoryDirector(LD)aregenerally

straightforwardandshouldbeclearlyidentifiedinyourJob

Descriptionrecord .Althoughtheresponsibilitiescanusuallybe

delegatedtoyourtechnicalstaff,theresponsibilityoftheaccuracyof

eachtestthatisrunthroughyourlaboratoryisultimately“your”

responsibility .

• The Laboratory Director must be accessible to the laboratory to

provide onsite, telephone or electronic consultation as needed.

AstheLDdutiesaremostlikelyincludedinalonglistofotherduties

forthisindividual,theremustbeaclearcommitmenttostay

constantlyavailabletothelaboratoryanditsstaff .Whennotonsite,

LDcontactinfoshouldbereadilyavailabletostaffandmultiple

contactoptionsshouldbemadeavailableandlistedinpriorityorder .

• May direct no more than five non-waived labs.

CLIAprohibitsaLaboratoryDirectorfromdirectingmorethanfive

non-waivedlaboratories .1CMS§493 .1407(d)CMS§493 .1445(d)

standards“NotethatforaCertificateofPPM,Certificateof

ComplianceorCertificateofAccreditation,anindividualcanonly

serveasthedirectorfornomorethanfivenon-waivedlaboratories .”2

Twostateshavemorestringentrestrictions:InPAaLabDirectormay

directnomorethantwonon-waivedlabs;andinGAaLabDirector

maydirectnomorethanthreenon-waivedlabs .

ThisrequirementisnotmeanttostifleLD’s,confinethemtoa

particularspecialtyorlimittheirincome .Thisrequirementismeant

toensurethatadequatetimeandattentionisspentoneach

laboratorytheyoversee .Thisisspecifictonon-waivedtestingas

therearemanydefinedrequirements,includingspecificQuality

Assessment/QualityControlmeasures .Compliancewiththese

requirementsmustnotonlybecloselymonitored,butalso

documentationreviewedandsignedoffonbytheLD .

• Ensure that the physical plant and environmental conditions are

appropriate for the testing performed and provide an

environment safe from physical, chemical, and biological hazards.

AstheLDitistheirresponsibilitytoassessyourfacilityforsafety .

Thisdoesnotlimititselftothetestbenchbutalsowhereverpatient

specimensarecollected/discarded,reagentsarehandled,andtesting

performed .Thesafetyplanshouldbecoordinatedwithyourfacility

maintenancemanager .Non-healthcarepersonnelshouldneverbe

allowedinthetestingareaotherthantoperformbuilding

maintenance,whichincludesbasiccleaningofthelaboratorybutnot

anyareaswheretherearebiologicalhazards .Forexample,building

maintenancecanmopthefloorsbutshouldnotbewipingoff

benchtops,instrumentsorrecords/filingsystems .Imaginetheworst

casescenariothatthereisabiologicalcontaminantthatwillnotbe

containedtoyourlaboratoryasbuildingmaintenanceworkerstravel

throughoutthefacility,oftenusingthesamecleaningsupplies/

materials .Propertrainingshouldbeprovidedtotestingpersonnelon

cleaningandmaintenanceofthephysicalplant .

Overallsafetyshouldbeconsideredinyourassessment .Removetrip/

fallhazardslikecordsorboxes .Allreagents,suppliesandinstruments

shouldbeproperlystoredandrecordskeptonordering,calibration

andmaintenance .Personalprotectiveequipmentshouldbemade

availabletotestingpersonnelandstoredproperly .

• Ensure compliance with all applicable regulations.

Thebestwaytoensurethatallapplicableregulationsarebeingmet

istoeducateyourselfandyourstaffontheregulations .FromOSHAto

FDA;Local,StateandFederalregulationsshouldbeavailabletoyour

staffandtrainingshouldoccurtoensurethatallstaffareadequately

knowledgeableonthetopic .Alsothereshouldbeamechanismin

placetoreviewtheregulationsandensurethatthemostcurrent

informationiscommunicated .Similartowhenanewlotofkitsor

reagentsisintroducedtoyourlaboratory,andyoureviewthe

packageinserttomakesuretheinstructionsforusehavenot

changed .

Key Tips: How can the General Responsibilities be met?

•Makesurethereisenoughcounterandstoragespacefor

testing .Ensurethatelectricalpower,includingshockand

powersurgeprotection,isadequate .

•AssurethatyourlaboratoryiscomplyingwiththeHazard

Communicationsstandard–seeUSCodeofFederal

Regulations29CFR1910 .1200,at:http://www .osha .gov/pls/

oshaweb/owadisp .show_document?p_table=standards&p_

id=10099andtheBloodbornePathogensstandard–seeUS

CodeofFederalRegulations29CFR1910 .1030,at:http://

www .osha .gov/pls/oshaweb/owadisp .show_document?p_

table=standards&p_id=10051 .

•Takeappropriatesafetymeasures,includingtheuseof

warninglabels,andtheprovisionofpersonalprotective

equipment .

•Assurethatenvironmentalconditions(temperature,

humidity,etc .)thatcanaffecttestingarebeingmonitored

andacteduponinyourlaboratory .


LAB DIRECTOR RESPONSIBILITIES LDR 1 E Does the Laboratory Director meet the General Responsibilities of the position?

•Review,becomefamiliarwith,andassurecompliancewith

theCLIAregulationsandtheCOLAcriteria .

•Review,becomefamiliarwith,andassurecompliancewith

anystateorlocallaboratoryregulationsthatapplytoyour

laboratory .

•Getinvolvedinthesurveyprocess(workwithyour

laboratorystafftocompletetheSelf-Assessmentbeforethe

survey)andtakeadvantageoftheeducationthata

surveyorcanprovide .

•Participateintheexitconferenceattheconclusionofyour

laboratoryinspection .

RESOURCES:

1 .COLAAccreditationManualp .48(revisedJune2013)

2 .Clinical Laboratory Improvement Amendments (CLIA)Application for Certification . http://www .cms .gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116 .pdf

C O L A’ S inSights N O V E M B E R / D E C E M B E R - 2 0 1 36

LAB DIRECTOR RESPONSIBILITIES LDR 2 E Does the Laboratory Director meet the Procedural Responsibilities of the position?

ThepurposeofthiscriterionistoensurethattheLaboratoryDirector

istheactive,hands-onleaderofthelaboratory .

•Ensuretestingsystemsprovidequalitylaboratoryservicesfor

pre-analytic,analytic,andpost-analyticphasesoftesting .

TheLaboratoryDirectorshouldbeactivelyinvolvedineachstageof

thetestingprocess .Fromspecimencollection,processingandtesting

toresultsreportingandinterpretation,theLDmustbeengaged .The

LDshouldcommunicatewithallpersonnelinvolvedineachstageof

testing .ThisincludesthePhlebotomist,MedicalAssistant,Nurse,or

MedicalTechnologistthatmaybecollectingsamplesinthepre-

analyticstage .ItincludestheMedicalTechnologist,Medical

LaboratoryTechnologistorothertestingpersonnelperformingthe

testprotocolintheanalyticalstage .Finallyitincludesthelaboratory

staffwhoreporttheresultseitherthroughanLISorEHRsystem,and

Clinicianswhowillinterprettheresultstodeliverpatientcare .

TheLDmustbeactiveinensuringthatallparticipantsineachstage

oftestingarenotonlytrainedbutcompetentinperformingthe

varioustestsystemsinthelaboratory .Documentationoftrainingand

theCompetencyAssessmentwillassistinensuringthatthe

laboratoryhastakeneverystageoftestingintoconsideration .

•Ensuretestmethodsselectedhavethecapabilityofproviding

qualityresults .

Itdoesnotneedtobeexplainedtotheexperiencedlaboratorianthat

notalltestmethodsprovidethesamequalityandaccuracy .Thereare

sometestmethodsthatareappropriateforscreeningversusothers

thatareusedforconfirmatorydiagnosis,andstillothersthat

functiontoprovideameasurementofaspecificanalyteforvarious

usesinpatientcare .AstheLaboratoryDirectortheymusttakethe

leadinresearchingtestmethodologies,howtheyareapplicableto

yourpatientpopulation,medicalsystem,etc .Therecannotbea

dependenceonthe“triedandtrue”methodssimplybecausethat’s

“whatwe’vealwaysdone .”

Thereshouldberegularreviewsperformedonvarioustestmethods

availableincomparisontoyourlaboratory’stestsystem

performance .Thisdoesn’tmeanthateverytimethereisanew

productorserviceoutyourlabisthefirstoneinlinetogetit,but

keepyourlaboratoryinformedofnewtechnologies .Theremaybe

trainingandeducation,softwareupgrades,add-onpackages,etc .that

mayenhanceyourcurrenttestsystematafractionofthecost .

ConverselynoLDwantstobeburdenedwithanobsoletetestsystem

regardlessoftheirtestingvolume .Agoodplacetostartwouldbeto

workwithsuppliersandmanufacturerstoselecttestmethodswith

provenaccuracythatmeetyourneeds .

•Ensureverificationproceduresusedareadequatetodetermine

accuracy,precision,andotherpertinentperformance

characteristicsofthemethod .

AspartofyourLaboratoryDirectorresponsibilitiesyoumustverify

thatthemanufacturer’sstatedperformancecharacteristicsare

achievedinyourlab(requiredforallnewnonwaivedmethodsadded

afterApril24,2003) .Continuetomonitorthetestmethod’s

performanceovertime .Allofthisshouldbeproperlydocumentedas

well .

•Ensurethatreportsoftestresultsincludepertinentinformation

requiredforinterpretation .

Whenreportingpatientresults,therearemanythingstotakeinto

consideration .Thetypeoftestordered,whentheresultsareneeded

back,andthedemographicsofthepatientjusttonameafew .The

testresultsthatyouarereportingtoclinicians,eitherviaanEHR,

addingtheresultsinthepatientchartorsendingtheresultsvia

courierorinter-officemail,shouldalwaysincludeinformationthatis

pertinenttointerpretationforpatientcare .Forexample:twounique

identifiers(patientname,DOB,age,etc .);sourceofspecimen(plasma,

serum,urine,etc .);ifmonitoringmedication(treatmentplan,

interactions,orefficacy)providethedate/timeoflastdose;any

restrictionsgiventopatient(i .e .-fasting) .

Itisalsoimportanttoprovideacriticalresultindicatorwithresults

reporting .Thiscouldbeanasterisknexttothetestresultvalueora

differentcolor/fontforthecriticalresultsothatitstandsoutamong

theresultsbeingreported .Bestpracticesalsoincludetheinclusionof

thenormaltestvaluerangeontheresultsreportingdocumentation .

Keepinmindthatjustbecauseyouhavehighlightedthecritical

value,thereisnoguaranteethattheclinicianfullyunderstandsthe

relevanceofthecriticalvalueinrespecttotreatmentoptionsfor

patientcare .Althoughthereissometrainingonlaboratoryservicesin

thecurriculumofthevariousschoolsofmedicine,theremaybe

variationinthelevelofknowledgeofwhatlabresultsmeanfor

varioustestsandalsohowtestresultsinterpretationvariesfrom

patienttopatientbasedonanumberofvariables .Itisthedutyofthe

LaboratoryDirectortoensurethatallpersonnelinvolvedinthe

post-analyticstageoftestingarewellversedinthemeaningbehind

thevaluesbeingreportedfromthelaboratory .Ifyouareunableto

providethisinformationresearchthevariouspartnerssuchasthe


LAB DIRECTOR RESPONSIBILITIES LDR 2 E Does the Laboratory Director meet the Procedural Responsibilities of the position?

manufacturerandthereferencelaboratoryforeducationalinformation

toshare .

These COLA criteria are directly related to this lab director

responsibility:

PST 9-16 Guidelines on what the test report should contain.1

•Ensurethatconsultationisavailabletothelaboratory’sclientson

mattersrelatingtothequalityofthetestresultsreportedandtheir

interpretationconcerningspecificpatientconditions .

Evenbeforethe2014FDArulingrequiringthatlaboratoriesprovide

laboratorytestinginformationtopatients,COLAaccreditedlaboratories

arerequiredtobepreparedtocommunicateeffectivelywiththe

laboratory’sclients .Thisincludespatientsandorderingphysicians .

Theremustbeaprotocolinplacetosharepertinentinformationfor

patientcarewitheachgroup .

•Ensurethatanapprovedproceduremanualisavailabletoall

personnel .

TheLDmustensurethatthereisareviewedandapprovedprocedure

manualforalltestsperformedinthelaboratory .Thismanualmustbe

availableatalltimesandaccessiblebyalltestingpersonnel .Forexample,

theonlycopyshouldnotbeintheLD’sofficewhichislockedduring

timeswhentheyarenotonsite .Thereshouldbedocumentationofthe

personnelreceivingfulltrainingonthecontentsoftheprocedure

manualaswell .

Ifanyadditionalinformationisneededtoensurethatyourlaboratory’s

proceduremanualiscompliantpleasereferenceCOLALabGuide1–

“ContentsofaProcedureManual .”


responsibility:

ORG 13 R Is the procedure manual easily accessible to your personnel?

Itisimportantforlaboratorypersonneltohaveeasyaccesstothe

proceduremanual .Staffshouldnotrelyonmemoryasthismaylead

toerroneousresultsiftheprocedureisn’trememberedcorrectly .2

ORG 16 R Does the LD sign and date each new procedure prior to use?

•Ensurethatlaboratorypersonnelareperformingthetestmethodsas

requiredforaccurateandreliableresults .

TheLaboratoryDirectorisdirectlyresponsibleforalltestresultsthatare

reportedfromthelaboratory .Thisresponsibilityisnottobetakenlightly

andtheguidelinesarespecifictoensurethattestingpersonnelhaveall

oftheresourcesnecessaryavailabletoensureaccurateresults .Foreach

criteriaforCOLAaccreditationthereisaclearmandatetoLD’stoensure

thataccurateandreliableresultsaretherequiredforeachsamplethatis

processedthroughthelaboratory .

Forexample,yourlaboratoryprotocolsstatetoonlyprocesspregnancy

testsforfemales,andifthepatientinformationstatesthatasampleto

betestedisfromamale,thenthereneedstobeareviewofthe

requisitionprocessanddiscussionwiththetestingpersonnelinvolvedin

thepre-analyticstage .


responsibility:

ORG 14 R Do personnel follow all procedures as written in the procedure

manual?

Ifyouhavesomeonefromoutsideyourpracticeprepareyour

proceduremanual,makesuretheproceduresreflectthewayyour

personnelactuallyperformthetestsinyourlaboratory .

NOTE: A copy of the manufacturer’s package insert or operator’s

manual, or a copy of a textbook description of the test procedure

may be used in the manual if it provides the information required

under Section APM. Any components of the test procedure that are

not addressed by the manufacturer, such as the steps to be taken

when a test system is malfunctioning, must be written into the

individual procedure. You can also maintain a general policy

statement in the laboratory for these procedures.3

PST 1 R Does your laboratory have a written procedure to correct laboratory

errors when they are detected?

Thelaboratorypolicyshoulddefinewhotonotifywhenanerror

occurs,howtocorrecttheerror,theimportanceofmaintainingthe

originalandcorrectedreportincasemedicaldecisionsor

procedureswereinitiatedbasedontheerroneousresult .Itshould

alsorequirethateachoftheseitemsbedocumentedforreviewas

partofthequalityassessmentprocess .

Itisimportantthatthelaboratorytrackerrorsandevaluatesthe

circumstancesassociatedwiththem,accordingtotheirestablished

IncidentManagementProgram,forconsiderationofpotentialharm

topatients .SeeCriteriaQA20 .4

PST 6 R Does the laboratory policy prohibit reporting test results when they

exceed the reportable range established by the laboratory and is

corrective action taken and documented in accordance with any

deviation in this policy?

Patientresultsshouldnotbereportedinnumberswhentheresults

exceedthereportablerange .Theresultsmaybereportedas“greater

than”themaximumverifiedreportablerange .Analternativetothis

wouldbetofollowthemanufacturer’sdirectionsfordilutinga

patientspecimenwhenitexceedsthereportablerange .When

>> CONTINUED ON PAGE 8


doingthis,however,don’tforgettomultiplytheresultyougetby

thedilutionfactor .5

Key Tips: How can the Procedural responsibilities be met?

•Workwithyourlaboratorystafftoselecttestsystemscarefully

andmonitortheirperformanceinthepre-analytic,analytic,and

post-analyticphasesoftesting .

•Workwithsuppliersandmanufacturerstoselecttestmethods

withprovenaccuracythatmeetyourneeds .

•Verifythatthemanufacturer’sstatedperformancecharacteristics

areachievedinyourlab .

•AssurethatQualityControlisperformed,thatitisregularly

reviewedbyappropriatetechnicalstafftomonitorthetest

method’sperformanceovertime,andthatwhenproblemsare

identified,theyarecorrectedpriortoreportingpatienttest

results .

•Ensurethatpersonnelfollowthemanufacturer’sdirectionsand

usegoodlaboratorypractices .

•Makesurethattestreportsincludeallnecessaryinformationthat

couldbesignificantforinterpretingtheresults .Forexample:

−Patientsexandage,

−Timeoflastdose,formedicationlevels,

−Thesourceofthespecimen,

−Ifthepatientwasfasting .

•Beavailabletodiscusslaboratoryresultswithlaboratoryclients

(orderingphysiciansorpatients) .

•Theproceduremanualmustincludeaprocedureforeverytest

performedandbeavailabletolaboratorypersonnel .

•Review,approve,dateandsignallproceduresbeforetheyareput

intouse .Review,approve,dateandsignallnewproceduresandall

changestoprocedures .

−AnewLabDirectormustreview,approve,dateandsignall

proceduresassoonastheybecometheLabDirector .

−Annualreviewofprocedurescanbedelegatedtoaqualified

individual,aslongastherearenochangestotheprocedures .

RESOURCES:

2,3,1 .COLAAccreditationManual(revisedJune2013)p .129

8,9 .COLAAccreditationManual(revisedJune2013)p .43

4 .COLAAccreditationManual(revisedJune2013)p .128


CONTINUEDFROMPAGE7

LAB DIRECTOR RESPONSIBILITIES | LDR 2 E

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AV1474-CLP-MAR14.indd 1 25/03/2014 14:32


TheLaboratoryDirectorshouldensurethatthestaffingofthe

laboratoryisnotonlyadequate-butappropriateforthetypeof

testingperformed .

•Employasufficientnumberoflaboratorypersonnelwiththe

appropriateeducationandeitherexperienceortrainingto

provideappropriateconsultation,properlysupervise,accurately

performtests,andreporttestresults .

AstheLaboratoryDirectoritistemptingtotakeontoomany,or

conversely,toofewtasks .SomeLD’sarethesoleproprietorandwear

manyhatsinthelaboratory .BeingtheGeneralSupervisor,Technical

Supervisor(forhighcomplexitylaboratories)andLaboratoryDirector

simultaneouslyisnotimpossible,butitmaybecomeoverwhelming .

Manytaskscanbedelegatedtootherqualifiedtestingpersonnel .

Thereshouldbeaclearworkflowforeachtestsystemthatidentifies

eachpersoninvolvedinthetestingprocessandhowtheiractions

interactwiththepreviousandnextstageoftesting .

Properstaffingisthecoreoflaboratoryexcellence .Ifyouhavetoo

manyortoofewtestingpersonneltheoutcomemaybeequallyas

debilitating .Ifyouhavetoofewpeopleduringashiftqualitycanbe

compromised,prioritytestingmaynotgetdoneandalitanyofother

shortstaffingchallengescanoccur .Iftherearetoomanypeople

duringashift,dutiesmaygounperformedduetostaffthinkingthat

“someoneelsehasdoneit .”TheLDmustfindtheperfectbalanceof

personneltokeepthelaboratoryasafe,effectiveandefficientplace

towork .

This COLA criterion is directly related to this lab director

responsibility:

PER2E

Are all required positions for your laboratory filled and are the

individuals filling those positions qualified by education and

experience?

Fordetailedinformationoneducationandexperiencerequirements

andeligibilitypathwaysforallCLIAdefinedpositions,refertothe

COLAAccreditationManual,SectionIII,and“PersonnelRequirements”

chartortoCOLALabGuide4“PersonnelforNonwaivedTesting .”If

yourstatehasmorestringentpersonnelstandardsorlicensure

requirementsthanCLIAandCOLA,thelaboratorydirectormust

ensurethatallpersonnelmeetthemorestringentrequirements .1

•Ensurethatpriortotestingpatientspecimens,allpersonnelhave

theappropriateeducationandexperience,receivetheappropriate

trainingforthetypeandcomplexityofservicesoffered,andhave

demonstratedthattheycanperformalltestingoperationsreliablyto

provideandreportaccurateresults .

Simultaneouslyasyouhirestaffforthelaboratoryyouarealso

ensuringthattheireducation,trainingandexperiencearecompliant

fortheleveloftestingtheywillbeperforming .Theserequirements

arenotinterchangeableandIwouldsay“thecomplexityneedstobe

determinedforthetestsystemused .”Aspartofyourlaboratory’s

plan,assurethatpersonnelareprovidedwithadequatetrainingfor

thedutiesandtestingthattheywillbeperforming .Thiscouldbe

completedbyhavingstaffattendamanufacturerstrainingsessionor

scheduledobservationofthetestbeingperformed .Personnelcan

viewtrainingvideos,webcasts,etc .togaininsightontestsystems .

TheLDmustverifythatallpersonnelhavedocumentationofthe

necessaryeducationandexperience .Bestpracticeswouldsuggest

thatmultiplecopiesofthedocumentationbekeptforplacementin

multipleplacessuchastheemployee’sfile,theQAmanualandtheLD

records .


responsibility:

PER3R

Does the personnel file contain documentation of the person’s

education and experience that qualifies them for the position they

hold in the laboratory?

CLIAspecifiestheeducationandexperiencethatanindividualmust

havetofilltherequiredpositions .Documentationshouldverifythe

highestlevelofeducationthatqualifiestheindividualforthe

positionheldinthelaboratory .Appropriatedocumentsincludea

copyofadiplomaordegree,oratranscriptindicatingdateof

graduation .Theseshouldbekeptinthepersonnelfileforreviewby

theCOLAsurveyor .Résumés,etc .,aresufficientfordocumenting

yearsofexperience .Foreigncredentialsmustbeevaluatedbyan

acceptablecredentialingagencyforUSequivalency .Language

translationofthedocumentsisnotsufficienttomeetthis

requirement

•Ensurethatpoliciesandproceduresareestablishedfor

monitoringindividualswhoconductpre-analytic,analytic,and

post-analyticphasesoftestingtoverifythattheymaintain

competency

− Toprocessspecimens,

− Performtestprocedures,and

− Reporttestresultspromptlyandproficiently .

LAB DIRECTOR RESPONSIBILITIES LDR 3 E Does the Laboratory Director meet the Personnel Management Responsibilities of the position?


Askthequestion“DoesyourLaboratoryDirectororTechnical

Supervisor/TechnicalConsultantfollowwrittenpoliciesand

procedurestoperiodicallyevaluatepersonnelperformanceand

competencyofallstaffinvolvedinpre-analytic,analytic,and

post-analyticphasesoftesting,aswellasthoseresponsiblefor

supervisionandconsultation?”Thatistheconceptofwhoneedsto

participateinaCompetencyAssessment .

AccordingtoCLIAregulationsandCOLAAccreditationCriteria

“Documentedcompetencyassessmentisrequiredforindividuals

fulfillingthefollowingpersonnelresponsibilitiesoutlinedinSubpart

MoftheCLIAregulations:clinicalconsultant(CC),technical

consultant(TC),technicalsupervisor(TS),generalsupervisor(GS)and

testingpersonnel(TP) .Clinicalconsultants,technicalconsultants,

technicalsupervisors,andgeneralsupervisorswhoperformtesting

onpatientspecimensarerequiredtohavethesixrequiredmethods

fortestingpersonnelintheirCompetencyAssessmentinadditionto

acompetencyassessmentbasedontheirFederalregulatory

responsibilities .”2

CRIContinuousQualityAdvisorIrwinRothenbergthinksof

CompetencyAssessmentintheseterms“Thinkabouttheeffecton

laboratoryqualitytohavecompetencyassuredforallthosewhose

activitiesdirectlyaffectthelaboratoryoperation .Onepossibilityisto

considerincorporationofcompetencyassessmentsoflaboratory-

relatedactivityintostaffevaluations .Itisalsoimportantto

rememberthatthisisoftenthestaffthatinteractsdirectlywith

patientsprovidingpre-testpreparationinformation .”3


responsibility:

PER5R

Does your director or Technical Supervisor/Technical Consultant

follow written policies and procedures to periodically evaluate

personnel performance and competency of all staff involved in

pre-analytic, analytic, and post-analytic phases of testing, as well as

those responsible for supervision and consultation?

Thisisnotsimplyareviewoftheindividual’sinitiative,interpersonal

relationships,andworkethicalthoughtheseareimportant

attributes .Thefocusofthisprocessistheindividual’sabilityto

performassignedtasksaccordingtodefinedprocessand

proceduretoassureaccurateandreliablelaboratoryresults .The

reviewmustaddressthecompetencyofeachindividualtofulfillthe

dutiesandresponsibilitiesoftheirpositionincludingassessmentof

actualtestperformanceandinterpretationofresults .

Allstaffaretobeincludedinthisprocessfrompersonnelinvolvedin

specimencollectionandprocessingtothoseresponsiblefor

supervisionandcompliance .Evaluationsshouldoccursemi-annually

forthefirstyearandannuallythereafterforalltestingpersonnel,

supervisorsandtechnicalconsultants .

Methodsofcompetencyassessmentmustinclude,whereapplicable:

•(i)Directobservationsofroutinepatienttestperformance,

includingpatientpreparation,ifapplicable,specimenhandling,

processingandtesting;

•(ii)Monitoringtherecordingandreportingoftestresults;

•(iii)Reviewofintermediatetestresultsorworksheets,quality

controlrecords,proficiencytestingresults,andpreventive

maintenancerecords;

•(iv)Directobservationofperformanceofinstrument

maintenanceandfunctionchecks;

•(v)Assessmentoftestperformancethroughtestingpreviously

analyzedspecimens,internalblindtestingsamplesorexternal

proficiencytestingsamples;and

•(vi)Assessmentofproblemsolvingskills .4

•Whenevernecessary,identifytheneedforremedialtrainingor

continuingeducationtoimproveskills .

AsaLDyouhavetheadditionalresponsibilityofidentifyingtheneed

foryourstafftoimprovetheirskills .Thiscanbeaccomplishedbya

varietyofmethods .Fromhavingthemparticipateintrainingona

newpieceofequipment,reviewingoperationmanualsor

educationalbrochures,totakingonlinecoursesandattending

conferencesandworkshops,thereisalwaysawaytokeepyourstaff

learning .Alltrainingandcontinuingeducationmustbedocumented

andverifiedbytheLD .


responsibility:

EVALUATIONGROUPING-PERSONNEL:TRAINING

The director must document personnel training in the personnel

files of laboratory staff, including his or her own file. Continuing

education is also important for staff, and can be provided by

one-on-one instruction, in-service programs, training on

instruments or kits by the manufacturer, or formal continuing

education activities such as LabUniversity®. Some states have

specific continuing education requirements for laboratory

personnel in order to meet licensure requirements. 5

•Maintainawrittenlistofresponsibilitiesofeachindividualinthe

laboratorythatspecifiesthelevelofactivityeachisauthorizedto

perform;whethersupervisionisrequiredforspecimenprocessing,

testperformanceorresultsreporting;andwhetherconsultantor

directorreviewisrequiredpriortoreportingpatienttestresults .

Eachpositioninthelaboratorymustcomewithaproperjob

description .Evenasnewresponsibilitiesanddutiesareaddedthey

LAB DIRECTOR RESPONSIBILITIES LDR 3 E Does the Laboratory Director meet the Personnel Management Responsibilities of the position?



mustbedocumentedfornotonlyaccountabilitybuttoensure

properutilizationofyourstaff .Ifyouareusingyoumostsenior

medicaltechnologistorderingofficesuppliesversusreviewing

QualityControldocumentation,thismaybeamisuseofyour

personnel’stimeandtalents .Therearemanyinstanceswhere

laboratorystaffareoverworkedyetstillunderutilized .Byclearly

identifyingwhatthedaytodayexpectationsofthetestingpersonnel

are,youcanthendelegateresponsibilitiesappropriatelyand

effectively .AccordingtoCRIContinuousQualityAdvisorNancyAlers

“Anadequatejobdescriptionoutlinesthemaindutiesor

responsibilitiesassociatedwiththeposition .Frommanagement’s

pointofview,havingadetailedjobdescriptionallowsforamore

targetedapproachwhenhiringbecauseitmakesclearwhatkindof

skills/knowledgeapersonmustpossessinordertofitthebill .”6

IfyouhavewaivedtestingthatcanbeperformedbyMedical

Assistants,butthenexpectthemtoalsoperformcertainnon-waived

testswhile“supervised”,thereisaclearmisconceptionoftheroles

andresponsibilitiesinyourlaboratory .Althoughthisexamplemay

seemextremeitcouldhappeniftheLDdoesnotunderstandthat

specificactivitiesrequireeducation,certificationandexperience .

Regardlessoftheperson’sseniority,howmanyyearstheyhavebeen

inthelab,theremustbeacleardefinitionofwhattheyarecanand

cannotdo .


responsibility:

PER1R

Is there a written job description for each employee that describes

individual duties and responsibilities?

Awrittenjobdescriptionaidsemployeesinunderstandingwhatis

expectedofthemanddefinestheirauthoritytoactand/ormake

decisionsinvariouscircumstances .Itshouldincludealistoftasks

andresponsibilitiesforallphasesoflaboratorytesting

(pre-analytic,analytic,andpostanalytic) .Thisisagoodplaceto

identifythelevelandtypeoftestingeachemployeeisqualified

toperform .7

•Inahighcomplexitylaboratory,ensurethatageneralsupervisor

providesonsitesupervisionofhighcomplexitytestperformance

byminimallyqualifiedtestingpersonnel .

TheLDinahighcomplexitylaboratoryisresponsibleforcomplying

withtheCMS/CLIA/COLAguidelinesforhighcomplexitylaboratories .

Individualswhorequiresupervisionqualifiedforhighcomplexity

testingviaSec .493 .1489(b)(5) .8

HIGH COMPLEXITY LABORATORIES (the full list of personnel

qualification categories is listed in the COLA Accreditation manual) 9

KEY TIPS: How can the Personnel Management responsibilities be

met?

•Beinvolvedinthehiringofpersonnelandmakesuretheyhave

thenecessaryeducationandexperience .

•Evaluatethevolumeoftestingperformed,thenumberoftesting

personnel,andturn-around-timestoensureadequatepersonnel

areavailable .

•Developjobdescriptionsforalllaboratorypersonnelandkeep

themupdated .

•Assurethatpersonnelareprovidedwithadequatetrainingfor

thedutiesandtestingthattheywillbeperforming .

•Verifythatallpersonnelhavedocumentationofthenecessary

educationandexperience .

•Assign,inwriting,theduties/responsibilitiestoeachperson

involvedinallphasesofthetestingprocessandkeepthelistof

assigneddutiescurrent .

•Establishstandardsforpersonnelperformanceandassurethat

personnelcompetencyreviewsarecompletedeverysixmonths

forfirstyear&annuallythereafter .Thisshouldinclude

observationofpersonnelastheyperformproceduralstepsinthe

pre-analytic,analyticandpost-analyticphasesoftesting .

•Requireandprovideremedialtrainingwhenneeded .

•Provideopportunitiesforcontinuingeducation .

•Highcomplexitydirectorsmustemployageneralsupervisorand

thatpersonmustbeonsitewhenhighcomplexitytestingis

performedbyindividualsthatrequiresupervisionasdescribedin

§493 .1489(b)(5)oftheCLIAregulations .

RESOURCES:


2 .COLA Accreditation Manual (July 2013) PERSONNEL REQUIREMENTS:PER 5p .65

3 .Lab Competency Assessment for Medical Office Staff Irwin RothenbergMBA, MS, MT(ASCP) . http://www .criedu .org/lab-competency-assessment-medical-office-staff/ .October29,2013 .



6 .Have you read your job description? Nancy Alers MS, MT(ASCP)CM . COLAResources Inc . Quality Advisor Blog . http://www .criedu .org/read-job-description/ .January24,2014


8 .CentersforMedicare&MedicaidServices,HHS§493 .1489Standard;Testingpersonnelqualifications .http://www .gpo .gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1489 .pdf(lastaccessedMarch2014)


CONTINUEDFROMPAGE11



LAB DIRECTOR RESPONSIBILITIES LDR 4 E Does the Laboratory Director meet the Proficiency Testing Responsibilities of the position?ProficiencyTestingisacriticalpointofensuringqualityinlaboratory

testing .TheLaboratoryDirectormusttakeavitalroleinPT

performance .

•EnsurethatthelaboratoryisenrolledinanapprovedProficiency

Testing(PT)program .

Thelaboratorymustenrollinanapprovedproficiencytesting(PT)

programasarequirementofCOLAaccreditation .Forpracticeswith

multiplelocations,eachofwhichhasitsownCLIAnumber,each

laboratorylocationmustenrollseparatelyinproficiencytestingand

independentlyperformitsownproficiencytesting .

ProficiencyTesting(PT),liketheCOLAAccreditationprogram,isan

independent,externalassessmentprovidingfeedbackonyour

laboratoryperformance .PTisonewayofcomparingyour

laboratory’sresultswithotherlaboratoriesusingthesame

instrumentorkit .AllCOLA-accreditedlaboratoriesmustenrolland

participateinanapprovedPTprogram .Proficiencytestingmeasures

thelaboratory’sabilitytoanalyzespecimensofunknownvalueand

obtainaccurateresultswithinanestablishedrange .Ifthelaboratory

hasadequateinstrumentmaintenance,personneltraining,and

qualitycontrolprocedures,proficiencytestingshouldbesuccessful .

Unsuccessfulproficiencytestingisanindicationofpossible

problemsintheseareas,andawarningthatpatienttestingmaynot

beaccurate .

ProficiencyTestingmustbeperformedonallregulatedanalytes .The

approvedPTprovidersofferthemajorityoftheregulatedanalytes

testedinlaboratories .Ifcertainregulatedanalytesarenotavailable

fromyourprimaryPTprovider,youshouldenrollwithanadditional

PTprogram .

COLAstronglyrecommendsthatlaboratoriesperformPTon

unregulatedanalytesasanaddedmeasureofexternalquality

assessment .IfthelabisnotenrolledinPTforunregulatedanalytes,

thensomeformofexternalcomparison,suchassplitspecimen

analysis,mustbeperformedtwiceyearly .AndbecauseCOLAbelieves

thatWaivedTestingisalsoimportanttopatientcare,COLAnowhas

aneducationalenforcementcriteriarequiringPTonwaivedtesting .

SeetheWaivedTestingEvaluationGrouping,WAV10 .1


responsibility:

PT1E

Have you been continuously enrolled, and have you successfully

participated in one or more CMS-approved Proficiency Testing (PT)

program(s) for all regulated analytes?

Enrollmentisrequiredforallregulatedanalytesonyourtestmenu .

SeethelistofapprovedPTprograms .YoushouldauthorizeyourPT

programtosendyourPTdatatoCOLAbysubmittingthePTData

ReleaseFormtoyourPTprovider(s) .Thisformservesasconfirmation

thatCOLAmayreceiveyourPTdata .Pleasecompletethisformand

forwardtoyourPTproviderandalsosendacopytoCOLAifyouhave

notdoneso .

•EnsurethatPTsamplesaretestedinthesamemanneraspatient

samples .

ProficiencyTestingspecimensmustbetestedinthesamefashionas

patientspecimens .Retainwrittendocumentationofeverystepof

testingtoverifythatPTspecimenshavebeenhandledproperly .

Specifically:

•TestPTsampleswiththeregularpatientworkloadusingroutine

methods

•TestPTsamplesthesamenumberoftimesasroutinepatient

specimens


responsibility:

PT5R

Do you follow the same procedures for testing PT samples as you do

for patient samples?

PTspecimensshouldbetreatedjustlikepatientspecimens—e .g .,ifa

patientspecimenisroutinelyrunonce,thePTspecimenmustberun

once .Inaddition,thepersonwhoperformsPTtestingshouldvaryif

morethanonepersonnormallyperformsthetestonpatients .(For

instance,thesupervisorshouldnotbetheonlypersonwhoperforms

testingonPTspecimens;allpersonswhoperformtestingonpatients

shouldtakeaturnatperformingPTtesting .)

NotifyyourPTprogrampriortothecut-offdateforresultsubmission

ofanyproblemswithPTspecimensorlabaccidentswithyourPT

specimens .ThePTprogramisobligatedtoprovidereplacement

samplesforspecimensnotreceivedontimeorfor“problems”suchas

samplesreceivedinaconditionthatrendersthemunacceptablefor

testing .NotifyyourPTprogramandCOLA,inwriting,ofanyincorrect

gradinginfinalreports .

•EnsurethatPTresultsarereturnedontimetothePTprogram .

EveryPTprogramhasaspecifictimeframethatthePTresultsmustbe

reportedby .Pleaserefertoyourlaboratory’sPTproviderforfurther

details .



•EnsurethatPTresultsarereviewedbytheappropriatestaffand

thecorrectiveactionplanisfollowedwhenPTresultsarefound

tobeunsatisfactory .

Ifyourlaboratoryfailsasingletestingevent,itreceivesa

performancescoreof“unsatisfactory”forthatanalyte .Your

laboratorymusttakeappropriateactiontoidentifytheproblem,

correctit,anddocumentthecorrectiveactioninthelaboratory

records .TheserecordswillbereviewedbytheCOLAsurveyorduring

documentreviewatyourlaboratory’son-sitesurvey .2


responsibility:

PT8R

Are all PT results reviewed and evaluated by the laboratory director or

other qualified designee in a timely manner?

Besuretodocumentthisreviewbydatingandinitialing .Inorderto

beeffectiveandtoprovidethelaboratorytimetotakeanyrequired

correctiveaction,thereviewshouldbecompletedwithin30days .

•EnsurethatPTsamplesaretestedaccordingtoCOLAandCLIA

regulationsprohibitingreferralofspecimensandcommunication

ofresults .

Theremaybenointer-laboratorycommunicationofresultsuntil

afterthedatethelaboratorymustreportPTresultstotheprogram

forthetestingevent .The laboratory must not send PT samples or

portions of samples to another laboratory for analysis which it is

certified to perform in its own laboratory .AnylaboratorythatCMS

determineshasintentionallyreferreditsPTsamplestoanother

laboratoryforanalysiswillhaveitsCLIAcertificationrevokedforat

leastoneyear .COLAwilldenyaccreditationtoalabifitintentionally

refersaPTspecimentoanotherlaboratoryforanalysis .COLAwillnot

acceptreapplicationforoneyear .

AnylaboratoryreceivingPTspecimensfromanotherlabfortesting

mustnotifyCMSofthereceiptofthosesamples .FailuretonotifyCMS

mayresultinrevocationofthereceivinglaboratory’sCLIAcertificate .

COLAwilldenyaccreditationtoalabifitintentionallyacceptsaPT

specimenfromanotherlaboratoryforanalysis .COLAwillnotaccept

reapplicationforoneyear .

TheindividualtestingthePTspecimenandthelaboratorydirector

mustsignanattestationstatementthatPTspecimensaretestedin

thesamefashionaspatientspecimens .RetainallPTrecordsfortwo

years .


responsibility:

PT6E

Does your laboratory policy prohibit communication with another

laboratory to discuss PT results, for both regulated and unregulated

analytes, prior to the cut-off date for submission of test results for

that event?

Nocommunicationisallowedpriortothecut-offdateforsubmission

oftestresultsforthatevent .

PT7E

Does your laboratory policy prohibit sending any PT samples to

another laboratory for analysis?

ThisincludesPTforregulated,unregulated,waived,andnon-waived

tests .SendingPTsamplestoanotherlaboratorytobetestedisa

directviolationoftheCLIAregulationsandwillresultinlossofyour

CLIAcertificate .

KEY TIPS: How can this responsibility be met?

•SelectanapprovedPTproviderthatmeetsyourneeds .

•MaintaincontinuousenrollmentinaPTprogram .

•Makesuretestingpersonnelunderstandalltherulesand

requirementsfortestingPTsamples,andtheimportanceof

submittingresultsontime .

•Review,initial,anddateallPTreportsandevaluateyourlab’s

performance .

•Requirestafftoinvestigateanyunacceptableresultsandany

resultsthatdonotreflectthelab’sperformance(seeCOLA

criterionPT10)andtotakecorrectiveactionwhenneeded .

Review,approve,initial,anddateallPTfailureinvestigations

conductedbyyourstaff .

•RetaindocumentationofallPTactivitiesfor2years .

RESOURCES:



CONTINUEDFROMPAGE14



LAB DIRECTOR RESPONSIBILITIES LDR 5 E Does the Laboratory Director meet the Quality Control and Quality Assessment Responsibilities of the position?QCandQAResponsibilitiesfallfirstontheLaboratoryDirectorasthe

leaderofthelaboratory .ItistheQC/QAactivitiesthatprovidethe

quantitativeandqualitativeanalysisoftheperformanceofyour

laboratoryonadaytodaybasis .

•EnsurethatQualityControlandQualityAssessmentprogramsare

establishedandmaintainedtoidentifyfailuresinqualityasthey

occur .

AstheLaboratoryDirectoritistheirresponsibilitytodevelop

comprehensivepoliciesandproceduresfortheperformanceand

acceptabilityofqualitycontrol .Thiswillcomefromdiligentresearch

oftestingprotocols,communicatingwiththestaffandwithyour

AccreditingOrganization .AccordingtoCMS“Thegenerallaboratory

systemsqualityassessmentmustincludeareviewofthe

effectivenessofcorrectiveactionstakentoresolveproblems,revision

ofpoliciesandproceduresnecessarytopreventrecurrenceof

problems,anddiscussionofgenerallaboratorysystemsquality

assessmentreviewswithappropriatestaff .Thelaboratorymust

documentallgenerallaboratorysystemsqualityassessment

activities .”1

Foreachnon-waivedtestonthelabmenu,decidewhethertofollow

theCLIAdefaultQCrequirementortodevelopandimplementthe

IndividualizedQualityControlPlan(IQCP) .See:http://www .cms .gov/

Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_

Control_Plan_IQCP .html

•Ensuretheestablishmentandmaintenanceofacceptablelevels

ofanalyticalperformanceforeachtestsystem .

Thiscriterionisonethatisreflectiveofthespecifictestinginyour

laboratory .Manythingscaninfluencetestsystems:volumeand

frequencyoftesting,andenvironmentalconditionstonameafew .

Youhavetoidentifywhatisacceptableperformanceinyour

laboratory .Thisprocessofseeingwhatworksbestforyourlabmust

alwaystakeintoconsiderationthemanufacturer’sinstructionsfor

thetestsystem .YourQCmustremaincompliantaspartofthis

process .

ReviewQCregularlytoconfirmthatpoliciesandproceduresare

beingfollowedbyallstaff .Developandimplementaquality

assessmentplanthatmonitorstheoverallqualityofthetotaltesting

processandensurescontinuousimprovementofthelaboratory’s

performanceandservices .IncludedinagoodQAprocessis

identificationofprocessdeviation,correctiveactiontoensure

deviationwillnotrepeat,COMMUNICATIONtostaffontheissueand

correctiveaction .Itwouldbealignedwithbestpracticestoalso

includeacopyofthecommunication .

•Ensurethatremedialactionsaretakenanddocumented

wheneversignificantdeviationsfromthelaboratory’sestablished

performancecharacteristicsareidentified,andthatpatienttest

resultsarereportedonlywhenthesystemisfunctioningproperly .

TheLDisresponsibleforestablishingwrittenpoliciesandprocedures

forevaluatingperformancespecifications .Specifytheremedial

actionstotakewhentheyarenotmet .

Makesurelaboratorypolicystatesthatpatientresultsarenottobe

reportedwhenthetestsystemisnotfunctioningproperly(i .e .,QCis

outofrange) .Alsoincludeguidancetorepeatanypatientspecimen

testingperformedwhenQCwasoutofrange .Documentandverify

thatallstafffollowsthispolicy .

Reviewandinitialqualitycontrolresults,graphs,andproblemlogs

regularlyandverifythatappropriateremedialactionsareperformed

anddocumented .

KEY TIPS: How can the Quality Control and Quality Assessment

responsibilities be met?

•Developcomprehensivepoliciesandproceduresforthe

performanceandacceptabilityofQualityControl .

•AssurethatappropriatetechnicalstaffreviewQCregularlyto

confirmthatpoliciesandproceduresarebeingfollowedbyall

staff .

•AssurethatappropriatetechnicalstaffreviewandinitialQuality

Controlresults,graphs,andproblemlogsregularly,andverifythat

appropriateremedialactionsareperformedanddocumented .

•DevelopandimplementaQualityAssessmentplanthatmonitors

theoverallqualityofthetotaltestingprocessandensures

continuousimprovementofthelaboratory’sperformanceand

services .

•AssurethatQAreviewsareeffectiveatidentifyingandpreventing

errors,andthatcorrectiveactionsarefollowedupfor

effectiveness .

•Establishwrittenpoliciesandproceduresforevaluating

performancespecifications .Specifytheremedialactionstotake

whentheyarenotmet .

•Makesurelaboratorypolicystatesthatpatientresultsarenotto

bereportedwhenthetestsystemisnotfunctioningproperly(i .e .,

QCisoutofrange,etc .) .Ensurethatallstafffollowthispolicy .


LAB DIRECTOR RESPONSIBILITIES LDR 5 E Does the Laboratory Director meet the Quality Control and Quality Assessment Responsibilities of the position?

RESOURCES:

1 .CMS§493 .1239Standard:Generallaboratorysystemsqualityassessment .http://www .gpo .gov/fdsys/pkg/CFR-2003-title42-vol3/xml/CFR-2003-title42-vol3-part493 .xml#seqnum493 .1239

To assist labs with this major change, CRI® has developed an Individualized Quality Control Program to help you implement the new CMS IQCP Guidelines. The CRI® IQCP Educational Program is designed to “put you in control of Quality Control.”

IQCP is quality control based on Risk Management. To successfully develop and implement IQCP, hospital laboratories and physician office labs must understand that IQCP is based on risk management concepts.

The CRI® IQCP Educational Program is the most comprehensive in the industry:

• Customized to the unique testing conditions in each laboratory: methods, utilization, environmental, and personnel competency that are clinically and economically beneficial

• Ability to optimize current QC/QA processes

• Adheres to federal, state and accrediting organization requirements

• Ensures continuous quality patient care with optimal clinical outcomes

• Identifies new initiatives and ongoing measures to improve the quality of patient care

The CRI® IQCP Program offers you a wide range of components to meet CMS’ IQCP guidelines.

The CRI® IQCP Program provides the building blocks necessary to develop a QC plan unique to your laboratory and allows your laboratory the flexibility to access the format that will best suit your needs.

The Program Portfolio Includes:

• CRI® IQCP E-Optimizer • CRI® IQCP Workshop Series

• CRI® IQCP Implementation Guide • CRI® IQCP Webinar Series

• CRI® IQCP Educational Video

CRI® Individualized Quality Control Program (IQCP)On January 1, 2014, the new Centers for Medicare & Medicaid Services (CMS) QC guidelines will go into effect! ARE YOU READY?

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CRI® Mission: “Provide educational and consultative services aimed at improving laboratory medicine and patient care.”


TheCOLAAccreditationcriteriawillsoonbechangedtoincludethe

requirementforLaboratoryDirectorstocompleteaminimumoffour

(4)continuingeducationcredits(CMEorP .A .C .E .)everytwoyears .Asa

COLAAccreditedlaboratoryyoumayhaverecentlyreceiveda

TechnicalBulletin“2014-3:NewSurveyCriteria-LDR6R”outliningthe

process .

Intheclinicallaboratorysetting,whetherpartofaphysician’soffice

laboratoryorthehospitalclinicallaboratory,goodlaboratory

practiceandqualitypatientcarearekeyobjectives .TheLaboratory

Directorisamongthekeypersonnelwhoplayamajorrolein

achievingtheseobjectives .TheLaboratoryDirectorisresponsiblefor

theoveralloperationofthelab,andthecompetencyofalllaboratory

personnel .LabDirectorresponsibilitiesfallintofivemajorcategories:

(1)GeneralDuties;(2)ProceduralDuties;(3)PersonnelDuties;(4)

ProficiencyTestingDuties;and(5)QualityControlDuties .1

ThenewCOLAcriterion,LDR6,willbeeffectivewhentherevised

AccreditationManualispublishedinthespringof2014,andreadsas

follows:

LDR 6 R Has the Laboratory Director completed, within the last

two years, four continuing education credits (CME or

PACE) from the COLA Laboratory Director Continuing

Education Program (LDCEP), or other equivalent

laboratory director education program?

DuetothesignificanceoftheCLIA-definedresponsibilitiesofthe

LaboratoryDirector,COLArequiresallLaboratoryDirectors,except

thosewhohavecompletedthequalifyingrequirementsforthis

positionwithinthelasttwoyears,tocompletefoureducationcredits

biennially .ToensurethatCOLALaboratoryDirectorsareabletomeet

thisnewrequirement,theLDCEPcontinuingeducationmodulesare

freeofchargeforCOLAlabs,andareavailablethroughLabUniversity

viaalinkonCOLAcentral® .

ToenrollintheCOLAcourses,gotowww.colacentral.com,lookunder

the“Education/Resources”tab>Selectmenuitem“LabDirector

ContinuingEducationforCOLALabs .”Thistakesyoutothe

descriptionpageonLabUniversity .Onlyonebundleisrequiredovera

twoyearperiod,andnewbundleswillbeaddedtothecurrent

offering .EachLDmayenroll in oneofthefollowingLaboratory

DirectorContinuingEducationcourseprograms:LDCEP1,LDCEP2,

LDCEP3orLDCEP4 .Eachofthesemodulesisfour(4)CMEcredits .To

takethecourseyoumustcreateanaccountonwww.LabUniversity.

org .OnceyouhaveselectedthecoursefromtheLabUniversity

catalogon“YourShoppingCart”pageyoumustkeyintheCoupon

Code“LDCEP”totakethecourseforfree .

AsLaboratoryDirectorsyouhavethechoicetoearncontinuing

educationhoursfromamultitudeofsources .Attendingwebinars,

symposiums,lectures,orothermeansofeducationmaybeapplicable

formeetingtheCOLALDR6criterion .Continuingeducationcredits

fromothersourceswillbeacceptedaslongasthesubjectmatteris

relevanttotheCLIA-definedLaboratoryDirectorresponsibilities .

COLAbelievesin“AccreditationthroughEducation .”Ourgoalisto

provideCOLAlaboratorieswiththeeducationaltoolstheyneedto

succeedinnotjustaccreditation,butalsoprovidingqualitypatient

care .

RESOURCES:

1 .COLATechnicalBulletin2014-3:NewSurveyCriteria-LDR6R

LAB DIRECTOR RESPONSIBILITIES LDR 6 R Laboratory Director Continuing Education Program


COLAisaddinganewcriteriontotheLaboratoryDirectorcriteriagrouping,requiringfourcontinuingeducationcreditsrelatedtoLaboratory

Directorresponsibilities,everytwoyearsforLaboratoryDirectors .

Intheclinicallaboratorysetting,whetherpartofaphysician’sofficelaboratoryorthehospitalclinicallaboratory,goodlaboratorypracticeand

qualitypatientcarearekeyobjectives .TheLaboratoryDirectorisamongthekeypersonnelwhoplayamajorroleinachievingtheseobjectives .

TheLaboratoryDirectorisresponsiblefortheoveralloperationofthelab,andthecompetencyofalllaboratorypersonnel .LabDirector

responsibilitiesfallintofivemajorcategories:(1)GeneralDuties;(2)ProceduralDuties;(3)PersonnelDuties;(4)ProficiencyTestingDuties;and(5)

QualityControlDuties .

ThenewCOLAcriterion,LDR6,willbeeffectivewhentherevisedAccreditationManualispublishedinthespringof2014,andreadsasfollows:

LDR 6 R Has the Laboratory Director completed, within the last two years, four continuing education credits (CME or PACE) from the COLA

Laboratory Director Continuing Education Program (LDCEP), or other equivalent laboratory director education program?

DuetothesignificanceoftheCLIA-definedresponsibilitiesoftheLaboratoryDirector,COLArequiresallLaboratoryDirectors,exceptthosewho

havecompletedthequalifyingrequirementsforthispositionwithinthelasttwoyears,tocompletefoureducationcreditsbiennially .Toenroll

intheCOLAcourses,gotowww .colacentral .comandenrollinoneofthefollowingLaboratoryDirectorContinuingEducationcoursemodules:

LDCEP1,LDCEP2,orLDCEP3 .Eachofthesemodulesisfourcredits .Continuingeducationcreditsfromothersourceswillbeacceptedaslongas

thesubjectmatterisrelevanttotheCLIA-definedLaboratoryDirectorresponsibilities .

TheLDCEPcontinuingeducationmodulesarefreeofchargeforCOLAlabs,andareavailablethroughCOLAcentral® .

Toaccessthecontinuingeducationmodules:

1 .Gotowww .colacentral .com

2 .LogontotheCOLAcentral®website .

3 .Goto“Education/Resources” .Select“LabDirectorContinuingEducationforCOLALabs” .

4 .ThistakesyoutothedescriptionpageonLabUniversity .

5 .Choosetheprogramyouwishbyclickingthe“Purchase”button .

6 .ThistakesyoutotheLabUniversityLoginpage .Click“StartBrowsing”toenterthecatalog .

7 .Againchoosetheprogramyouwantandaddittothecart .

8 .ProceedtoyourCart .

9 .Onthispage,youmustentertheCouponCode“LDCEP”andclick“Apply”forthediscounttobeapplied .

10 .ThePurchasetotalwillgotozero .

11 .ProceedtoCheckout .EitherSignInontheInformationpageifyouareacurrentlearneronLabUniversityoryoumay

CreateaNewAccount .


General Responsibilities How can I meet this reponsibility?

Mustbeaccessibletothelaboratorytoprovideonsite,telephone

orelectronicconsultationasneeded .

•Makesurethereisenoughcounterandstoragespacefor

testing .Ensureadequateelectricalpowerthatincludesshock

andpowersurgeprotection .

•Takeappropriatesafetymeasures,usewarninglabels,and

providepersonalprotectiveequipment .

•Monitorenvironmentalconditions(temperature,humidity)that

canaffecttesting .

•ReviewandbecomefamiliarwiththeCLIAregulationsorthe

requirementsofyouraccreditingorganization,ifapplicable .

•Reviewandbecomefamiliarwithanystateorlocallaboratory

regulationsthatapplytoyourlaboratory .

•Getinvolvedinthesurvey(inspection)processandtake

advantageoftheeducationthatasurveyorcanprovide .

Maydirectnomorethanfivenonwaivedlabs .

Ensurethatthephysicalandenvironmentalconditionsare

appropriateforthetestingperformedandprovidean

environmentsafefromphysical,chemical,andbiological

hazards .

Ensurecompliancewithallapplicableregulations .

Verifythatresponsibilitiesthatcanbedelegatedareproperly

performed,ifdelegated .

Procedural Responsibilities How can I meet this reponsibility?

Ensuretestingsystemsprovidequalitylaboratoryservicesfor

pre-analytic,analytic,andpost-analyticphasesoftesting .

•Selecttestsystemscarefullyandmonitortheirperformancein

thepre-analytic,analytic,andpost-analyticphasesoftesting .

•Workwithsuppliersandmanufacturerstoselecttestmethods

withprovenaccuracythatmeetyourneeds .

•Verifythatthemanufacturer’sstatedperformance

characteristicsareachievedinyourlab(requiredforallnew

nonwaivedmethodsaddedafterApril24,2003) .

•Reviewqualitycontrolforthetestandmonitorthetest

method’sperformanceovertime .

•Ensurethatpersonnelfollowthemanufacturer’sdirectionsand

usegoodlaboratorypractices .

•Makesurethattestreportsincludeallnecessaryinformation

thatcouldbesignificantforinterpretingtheresults .For

example:

•Patientsexandage

•Timeoflastdoseformedicationlevels

•Thesourceofthespecimen

•Ifthepatientwasfasting

•LMPforPapSmears

•Beavailabletodiscusslaboratoryresultswithpatients .

•Theproceduremanualmustincludeaprocedureforeverytest

performedandbeavailabletolaboratorypersonnel .

•Reviewandsigntheproceduremanualatleastannuallyand

sign,date,andapprovenewproceduresbeforefirstuse .

Ensuretestmethodsselectedhavethecapabilityofproviding

qualityresults .

Ensureverificationproceduresusedareadequatetodetermine

accuracy,precision,andotherpertinentperformance

characteristicsofthemethod .

Ensurethatreportsoftestresultsincludepertinentinformation

requiredforinterpretation .

Ensurethatconsultationisavailabletothelaboratory’sclients

onmattersrelatingtothequalityofthetestresultsreportedand

theirinterpretationconcerningspecificpatientconditions .

Ensurethatanapprovedproceduremanualisavailabletoall

personnel .

Ensurethatlaboratorypersonnelareperformingthetest

methodsasrequiredforaccurateandreliableresults .

Meeting Laboratory Director Responsibilities A handy reference guide of methods Laboratory Directors can use to meet the COLA LDR Criteria


Personnel Responsibilities How can I meet this reponsibility?

Employasufficientnumberoflaboratorypersonnelwiththe

appropriateeducationandeitherexperienceortrainingto

provideappropriateconsultation,properlysupervise,and

accuratelyperformtestsandreporttestresults .

•Getinvolvedinthehiringofpersonnelandmakesuretheyhave

thenecessaryeducationandexperience .

•Evaluatethevolumeoftestingperformed,thenumberof

testingpersonnel,andturn-aroundtimes .

•Providepersonnelwithtrainingforthedutiesandtestingthat

willbeperformed .

•Observepersonnelastheyperformpre-analytic,analyticand

post-analyticphasesoftesting .

•Verifythatallpersonnelhavedocumentationofthenecessary

educationandexperience .

•Providepersonnelwithtrainingforthedutiesandtestingthat

willbeperformedandensurethatthetrainingisadequate .

•Developjobdescriptionsforalllaboratorypersonnelandkeep

uptodate .

•Assign,inwriting,theduties/responsibilitiestoeachperson

involvedinallphasesofthetestingprocessandkeepthelistof

assigneddutiescurrent .

•Establishstandardsforpersonnelperformanceandconduct

personnelcompetencyassessments(every6mofor1styear&

annuallythereafter) .

•Requireandprovideremedialtrainingwhenneeded .

•Provideopportunitiesforcontinuingeducation .

•Highcomplexitydirectorsmustemployageneralsupervisor

andthatpersonmustbeonsitewhenhighcomplexitytestingis

performedbyindividualsthatrequiresupervisionasdescribed

intheCLIAregulations[individualswhoqualifiedforhigh

complexitytestingviaSec .493 .1489(b)(4) .]

Ensurethatpriortotestingpatientspecimens,allpersonnelhave

theappropriateeducationandexperience,andreceivethe

appropriatetrainingforthetypeandcomplexityofservices

offered,andhavedemonstratedthattheycanperformalltesting

operationsreliablytoprovideandreportaccurateresults .

Haveawrittenlistofresponsibilitiesofeachindividualinthe

laboratorythatspecifiesthelevelofactivityeachisauthorized

toperform,whethersupervisionisrequiredforspecimen

processing,testperformanceorresultsreporting,andwhether

consultantordirectorreviewisrequiredpriortoreporting

patienttestresults .

Ensurethatpoliciesandproceduresareestablishedfor

monitoringindividualswhoconductpre-analytic,analytic,and

post-analyticphasesoftestingtoverifythattheymaintain

competencytoprocessspecimens,performtestprocedures,and

reporttestresultspromptlyandproficiently .

Whenevernecessary,identifyneedsforremedialtrainingor

continuingeducationtoimproveskills .

Ensurethatageneralsupervisorprovideson-sitesupervisionof

highcomplexitytestperformancebycertaintestingpersonnel .

Meeting Laboratory Director Responsibilities A handy reference guide of methods Laboratory Directors can use to meet the COLA LDR Criteria



PT Responsibilities How can I meet this reponsibility?

Ensurethatthelaboratoryisenrolledinanapprovedproficiency

testing(PT)program .

•SelectanapprovedPTproviderthatmeetsyourneeds .

•MaintaincontinuousenrollmentinaPTprogram .

•Makesurelabstaffunderstandsalltherulesandrequirements

fortestingPTsamples,andtheimportanceofsubmitting

resultsontime .

•Review,initial,anddateallPTreportsandevaluateyourlab’s

performance .

•Investigateanyunacceptableresultsandanyresultsthatdo

notreflectthelab’sperformanceandtakecorrectiveaction

whenneeded .

•RetaindocumentationofallPTactivitiesfor2years .

EnsurethatPTsamplesaretestedinthesamemanneraspatient

samples .

EnsurethatPTresultsarereturnedontimetothePTprogram .

EnsurethatPTresultsarereviewedbytheappropriatestaffand

thecorrectiveactionplanisfollowedwhenPTresultsarefound

tobeunsatisfactory .

QC and QA Responsibilities How can I meet this reponsibility?

Ensurethatqualitycontrolandqualityassessmentprogramsare

establishedandmaintainedtoidentifyfailuresinqualityasthey

occur .

•Developcomprehensivepoliciesandproceduresforthe

performanceandacceptabilityofqualitycontrol .

•Foreachnonwaivedtestonthelabmenu,decidewhetherto

followtheCLIAdefaultQCrequirementortodevelopand

implementIQCP .See:http://www .cms .gov/Regulations-and-

Guidance/Legislation/CLIA/Individualized_Quality_Control_

Plan_IQCP .html

•ReviewQCregularlytoconfirmthatpoliciesandproceduresare

beingfollowedbyallstaff .

•Developandimplementaqualityassessmentplanthat

monitorstheoverallqualityofthetotaltestingprocessand

ensurescontinuousimprovementofthelaboratory’s

performanceandservices .

•MakesurethatQAreviewsareeffectiveatidentifyingand

preventingerrors,andcorrectiveactionsarefolloweduponfor

effectiveness .

•Establishwrittenpoliciesandproceduresforevaluating

performancespecifications .Specifytheremedialactionsto

takewhentheyarenotmet .

•Makesurelaboratorypolicystatesthatpatientresultsarenot

tobereportedwhenthetestsystemisnotfunctioningproperly

(i .e .,QCisoutofrange) .Verifythatallstafffollowsthispolicy .

•Reviewandinitialqualitycontrolresults,graphs,andproblem

logsregularlyandverifythatappropriateremedialactionsare

performedanddocumented .

Ensuretheestablishmentandmaintenanceofacceptablelevels

ofanalyticalperformanceforeachtestsystem .

Ensurethatremedialactionsaretakenanddocumented

wheneversignificantdeviationsfromthelaboratory’s

establishedperformancecharacteristicsareidentified,and

patienttestresultsarereportedonlywhenthesystemis

functioningproperly .

COLA, an internationally-respected, non-profit clinical laboratory accreditation organization has been awarded deemed status from Laboratory Field Services (LFS) in California.

Clinical Laboratories in California can now choose COLA for their laboratory

accreditation. Laboratories in CA that are accredited by COLA under its deeming

status and who pass their surveys will meet state and federal requirements. Thus

CA laboratories can meet dual requirements with one accreditation.

COLA’s Accreditation Program in CA is centered on 5 key components:

1 A focus on ongoing education

2 Customer support line

3 Continuous Quality Advisors

4 COLAcentral, a real-time web portal to enable labs to track their accreditation status and manage lab operations more efficiently

5 Consultative approach

COLA knows California

COLA is the first private laboratory organization to receive deemed status by LFS

due to its in-depth knowledge of California’s unique clinical laboratory licensure laws and its

experience accrediting 8,000 laboratories nationally and nearly 500 in California.

The laws and regulations in this state are complex and continually evolving. COLA keeps current on

changes and can help guide you to ensure that you are in compliance with state mandates.

COLA chosen as first private laboratory organization to receive state deeming authority in CA.

To learn more call 800-981-9883 or go to COLA’s dedicated California web portal:

www.cola.org/CA

CONSULTATIVEAPPROACH

ONGOINGEDUCATION

CUSTOMERSUPPORT

QUALITYADVISORS

COLA CENTRAL

9881 Broken Land Pkwy Suite 200 | Columbia, MD 21046-3016Phone (800) 981-9883 | Fax (410) 381-8611 | Email [email protected]

COLA is ISO 9001: 2008 certified

CONTINUEDFROMPAGE23

MEETING LABORATORY DIRECTOR RESPONSIBILITIES


COLA, an internationally-respected, non-profit clinical laboratory accreditation organization has been awarded deemed status from Laboratory Field Services (LFS) in California.

Clinical Laboratories in California can now choose COLA for their laboratory

accreditation. Laboratories in CA that are accredited by COLA under its deeming

status and who pass their surveys will meet state and federal requirements. Thus

CA laboratories can meet dual requirements with one accreditation.

COLA’s Accreditation Program in CA is centered on 5 key components:

1 A focus on ongoing education

2 Customer support line

3 Continuous Quality Advisors

4 COLAcentral, a real-time web portal to enable labs to track their accreditation status and manage lab operations more efficiently

5 Consultative approach

COLA knows California

COLA is the first private laboratory organization to receive deemed status by LFS

due to its in-depth knowledge of California’s unique clinical laboratory licensure laws and its

experience accrediting 8,000 laboratories nationally and nearly 500 in California.

The laws and regulations in this state are complex and continually evolving. COLA keeps current on

changes and can help guide you to ensure that you are in compliance with state mandates.

COLA chosen as first private laboratory organization to receive state deeming authority in CA.

To learn more call 800-981-9883 or go to COLA’s dedicated California web portal:

www.cola.org/CA

CONSULTATIVEAPPROACH

ONGOINGEDUCATION

CUSTOMERSUPPORT

QUALITYADVISORS

COLA CENTRAL

9881 Broken Land Pkwy Suite 200 | Columbia, MD 21046-3016Phone (800) 981-9883 | Fax (410) 381-8611 | Email [email protected]

COLA is ISO 9001: 2008 certified


inSights SPOTLIGHT: LABORATORY EXCELLENCE AWARD

AsanewfeatureinCOLA inSightsCOLAwill

befeaturingalaboratorythathasshown

excellencenotonlyintheircompliancewith

accreditationstandards,butalsooverallhigh

qualitypatientcare .COLAAccredited

laboratoriesthatmeettheLaboratory

ExcellenceAward(LEA)criteriaintheirpast

surveyhavehadnocitations;no

unsuccessfulProficiencyTesting(PT)forany

regulatedanalyte/subspecialty/specialtyfor

thepast2years,andhadnosubstantiated

complaintsforthepast2years .

About the Lab:

NightLitePediatricsUrgentCareisthe

leadingpracticeforoutpatienturgent

medicalcareofchildrenandadolescents

needingemergencyservicesintheevenings

andweekendsinCentralFlorida .NightLite

Pediatricsismanagedbyboardcertified,

criticalcaredoctors .TherearenineCentral

Floridalocations,openuntilmidnightevery

dayoftheyear .

ThislocationhasreceivedtheLaboratory

ExcellenceAwardforthethirdconsecutive

year .NightLitePediatricsUrgentCareisthe

fastestgrowingpediatricurgentcarein

Florida,seeingover50,000patientsannually .

ThisyearisNightLitePediatrics’10Year

Anniversary .

NightLitePediatricsprovidesrapiddiagnosis

andcare,includingon-sitelaboratoryand

radiologyservices,apatientobservation

area,procedureroomsforthetreatmentof

lacerationsandfractures,IVaccessand

spinaltaps .Thecenterstreatminorbroken

bones,lacerations,sprains,fevers,diarrhea,

vomiting,dehydrationandear,noseand

throatinfections .NightLitePediatricsalso

treatschildrenwithasthmaandrespiratory

illnesses,aswellaschronicillnessessuchas

diabetes,cysticfibrosis,Crohn’sdiseaseand

colitis .

CONGRATUALTIONS TO THE STAFF AT NIGHT LITE

PEDIATRICS! KEEP UP THE GREAT WORK!

NIGHT LITE PEDIATRICS URGENT CARE

Oviedo,FL

LaboratoryDirector:AyodejiOtegbeye,MD

LaboratoryManager:TejalV .Desai

SpecialSpotlight


MedicalLaboratoryProfessionalsWeek

(MLPW),heldannuallyduringthelastfull

weekofApril,isacelebrationofthemedical

laboratoryprofessionalsandpathologists

whoplayavitalroleinhealthcare .MLPWis

atimeformedicallaboratorypersonnelto

celebratetheirprofessionalismandbe

recognizedfortheirefforts .Itaffordsan

opportunitytoinformandeducatemedical

colleaguesandthepublicaboutthemedical

laboratoryandtheimpactofthese

dedicated,skilledprofessionalshaveonthe

qualityofoverallpatientcare .

Becauselabpersonneloftenworkbehindthe

scenes,fewpeopleknowmuchaboutthe

criticaltestingtheyperformeveryday .

Fewerstillhaveanunderstandingofthe

industry’slongandproudtradition,dating

backtotheearly1900s .Whatfollowsisa

shorthistoryoftheprofession’sbeginnings,

includingprofilesofseverallaboratory

industry“pioneers .”Wehonortheir

contributionsandthoseofthousandsof

otherlaboratoriansasweobservedMLPW!

HISTORYOFTHEPROFESSION

Themedicallaboratoryprofessionformally

beganinthe1920s,followingtheinvention

andwidespreaduseofdiagnostictoolssuch

asthemicroscope;priortothatmostlab

testingwasperformedbyphysicians .Inthe

late1890s,somemedicalprofessionalseven

arguedthathospitallabswerescientific

“luxuries,”requiringtoomuchspaceand

expensetoadminister,andthatclinicaltests

weretootimeconsumingtoconduct .Ina

1900articleintheJournaloftheAmerican

MedicalAssociation,Dr .CharlesNicoll

BanckerCamac,DirectoroftheLaboratoryof

ClinicalPathologyatCornellUniversity,

defendedtheneedforhospitallabs,refuting

suchpopularmisconceptionsaspatients

mightaccidentallydrinkpoisonous

laboratoryreagents,orstaffmembersmight

appropriatelaboratoryapparatusfortheir

personaluse .Camacwentontosuggestthat

“themaintenanceofthelaboratorycanwell

beaccomplishedon$50ayear”!1

Earlylaboratorytechniciansreceived

on-the-jobtrainingunderthedirect

supervisionandtutelageofhospital

pathologists .In1928,theAmericanSocietyof

ClinicalPathologistsestablishedastanding

committeecalledtheBoardofRegistry

whosepurposewastoestablish

requirementsforlabtechniciancertification .

In1933,thisgrouppublishedalistof34

accredited“schools .”Moststudentsentering

thesehospital-basedprogramswerehigh

schoolgraduates .Theearliestprograms

includedthoseatUniversityofWisconsin,

UniversityofMinnesota,andUniversityof

TexasMedicalBranch .2,3,4

Manyofthepioneersoftheprofessioninthe

Americawereactivelyinvolvedineducation,

andhelpedtoadvancetheprofessionby

expandingacademicprogramsdedicatedto

laboratorymedicine .Followingaresome

notableexamples:

WALTERREED(1851–1902),wasborninHarrisonburg,Virginia,theyoungestchildof

afamilyoffive

whosefather

wasa

Methodist

minister .Reed

studied

medicineat

theUniversity

ofVirginia,

obtaininghis

M .D .attheageof18-theyoungestmedical

graduatethenknown .Apromotionto

CaptainintheU .S .Armybroughthimto

Baltimoreandgave

himtheopportunitytoundertakefurther

studyatJohnsHopkinsUniversity .

In1893Reedwasappointedcuratorofthe

ArmyMedicalMuseumandProfessorof

BacteriologyandClinicalMicroscopyatthe

MilitaryAcademyinWashington .Withthe

outbreakoftheSpanish-AmericanWarin

1898heappliedforactiveserviceandwas

postedfordutyinCuba,firsttostudytyphoid

andsubsequentlyasDirectorofYellowFever

Commission .In1901heledtheteamthat

postulatedandconfirmedthetheorythat

yellowfeveristransmittedbyaparticular

mosquitospecies,ratherthanbydirect

contact .Thisinsightgaveimpetustothenew

fieldsofepidemiologyandbiomedicine,and

mostimmediatelyallowedtheresumption

andcompletionofworkonthePanama

Canal(1904–1914)bytheUnitedStates .

Sadly,oneyearafterhisreturntripfrom

Cuba,MajorReeddiedfromperitonitis

followinganappendectomyperformedby

hisfriend,MajorWilliamC .Borden,

CommanderoftheArmyGeneralHospital .

FollowingReed’sdeath,Bordenbecame

dedicatedtoseeingthecompletionofanew

hospitalwhichwouldco-locatetheArmy

hospital,theArmyMedicalSchool,theArmy

MedicalMuseumandtheSurgeonGeneral’s

Library .Bordenwasinstrumentalinnaming

thenewhospitalintheNation’scapital

Washington,D .C .afterhisfriend,Major

WalterReed .

EMMAPERRYCARR(1880–1972),wasborninHolmesville,Ohio .Herfatherand

grandfather,bothcountrydoctors,valued

andencouragededucationfortheirchildren .

AfterCarrgraduatedfromhighschool,she

enteredMountHolyokeCollege,awomen’s

collegeinMassachusetts .Afterearningher

Ph .D .in1910shereturnedtoMountHolyoke

COLA Salutes Medical Laboratory ProfessionalsA Salute to Laboratory Professionals, Yesterday and Today



COLA Salutes Medical Laboratory ProfessionalsA Salute to Laboratory Professionals, Yesterday and Today


CONTINUEDFROMPAGE28

COLA SALUTES MEDICAL LABORATORY PROFESSIONALS WEEK

tojointhe

facu

insightsmarch/april — 2014newsletter.cola.org/2014/april/insights.pdf · 2014. 12. 23. ·...

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