Accreditation Education Innovation - COLA€¦ · Accreditation Education Innovation COLA.ORG Due to the audit performed by the CQA, the laboratory was able to take immediate steps

Accreditation Education Innovation9881BrokenLandParkway,Suite200|Columbia,MD21046

P410.381.6581|F410.381.8611|Wcola.org|InformationResourceCenter800.981.9883

ISO9001:2008

COLA at a Glance

WHO WE ARE: COLAisaphysician-directedorganizationwhosepurposeistopromoteexcellence

inlaboratorymedicineandpatientcarethroughaprogramofvoluntary

education,consultation,andaccreditation.

WHY WE EXIST: COLAwasfoundedin1988asaprivatealternativetohelplaboratoriesstayin

compliancewiththenewClinicalLaboratoryImprovementAmendments(CLIA).In

1993,theHealthCareFinancingAdministration(nowCMS)grantedCOLAdeeming

authorityunderCLIA,andin1997theJointCommissiononAccreditationof

HealthcareOrganizations(JCAHO)alsorecognizedCOLA’slaboratory

accreditationprogram.

WHO WE SERVE: COLAservesalmost8,000medicallaboratoriesnationwide,makingitthelargest

privateaccreditor.

WHAT WE OFFER: COLA’sgoalistoimprovepatientsafetybypromotinglaboratoryexcellence.By

servingasaneducatorandapartnertolaboratories,wemaketheaccreditation

processsimple,quick,andtailoredtomeetspecificneeds.Moreimportantly,the

holisticapproachwetakemakesusadailyforceforqualityinthelaboratorieswe

serve–notjustonceeverytwoyears.

HOW WE INNOVATE: COLAoffersabroad selection of educational products, services, and

informational tools–includingwebinars,biannualsymposia,publications,web

toolslikeCOLAinsider.com,andreadyaccesstoexpertopinion–not

availableelsewhere.

Ourtechnological tools–likeCOLAcentral,wherelaboratoryprofessionalscan

updatetheirlabprofile,viewcommunications,seesurveyresults,preparefor

upcomingsurveysandreceivesupportforawholerangeoflaboratoryneeds,and

Eval,whichallowsCOLAsurveyorstoprovidepaperless,preliminaryresultsonthe

spot–delivervaluetoourclients.

COLAisalsowillingtosubjectitselftothesamekindofthirdpartyreviewoursurveyors

performforourcustomers.COLAisregisteredunderISO Standard 9001: 2008–theonly

healthcareaccreditationorganizationdeemedbyCMStobesocertified.

COLA Members

Board of Directors

KeithE.Davis,M.D.

BradleyJ.Fedderly,M.D.,

Chair

R.W.“Chip”Watkins,M.D.

RichardS.Eisenstaedt,M.D.

R.BradleySlease,M.D.

DonnaE.Sweet,M.D.

SusanR.Bailey,M.D.

WilliamE.Kobler,M.D.

GeorgiaA.Tuttle,M.D.

VerlinK.Janzen,M.D.

LezleeA.Koch,M.T.

KarlaMurphy,M.D.

AAFP Appointees ACP Appointees AMA Appointees Board Elected

DOUGLAS A. BEIGEL, CHIEF EXECUTIVE OFFICER, COLA

PromotedtoCEOafterservingasChiefOperatingOfficerofCOLAsince1987,Mr.Beigelleadsa

dynamicteamresponsibleforhelpingnearly8,000laboratoriesacrossthecountryfulfilltheir

accreditationobligationsunderthefederalClinicalLaboratoryImprovementAmendments

(CLIA)of1988,acomplexprocessinvolvingmultiplelayersofgovernment.COLAstaffhas

performedmorethan70,000surveyssince1988.

UnderMr.Beigel’sleadership,COLAhasbecomearecognizedthoughtleaderinthefieldof

laboratorymedicine,introducinganumberofindustry“firsts,”suchas:

•Developingthefirst-everQualityManagementSystem(QMS)forlaboratoryaccreditationintheUnitedStates.

•BecomingthefirstCMS-deemedaccreditortoachieveandmaintaincertificationunderISO’srigorous9001:2008

standardaffecting“qualitymanagementsystems.

•Devisingauniversalaccreditationmodelthatcanbeadaptedbyanyorganizationinanyfieldtoreviewthe

implementationofqualitystandards,whilepreservingopportunitiestomakeprocessimprovements.

•Applyingaholisticapproachtoaccreditation,stressingeducation,consultation,andtechnologicalinnovation.COLA

provideslaboratorieswiththeguidancetonavigateacomplexaccreditationprocess,whileprovidingthe

information,expertadvice,classroomopportunities,andemergingbestpracticesintheareaofqualitycontrol.

•Creatingagroundbreakinglaboratorymanagementdesktoptool(www.colacentral.com)thatgiveslaboratory

personneltheabilitytomanageregulatorycompliancerequirementselectronically.

COLA CEO

Clinical Laboratories at a Glance

DID YOU KNOW?

In1988therewerefewerthan8waivedtests.Todaythereareover300.~CMS

In198878,825labsheldacertificateofwaiver.Todaytherearenearly154,000.~CMS

Morethan40,000currentlabjobsarevacantintheUnitedStates.~BureauofLaborStatistics.

Thenumberofclinicallabworkersissettoriseabout16percentbetween2008and2018,addingabout

25,000jobs.~U.S.LaborDepartmentstatistics

85percentofalllaboratorytesting(waivedtestingplusPPM)isunregulated.

8.2%

69.0%

16.0%

6.8%

CLIA Labs by Certificate Type (Non-Exempt Only)

vider Performed Microscopy

Accreditation Compliance

Waiver

CMS CLIA database 06/2013

Pro

Source:

CLIA Labs by Certifi cate Type(Non-ExemptOnly)

8.2%

69.0%

16.0%

6.8%

CLIA Labs by Certificate Type (Non-Exempt Only)

vider Performed Microscopy

Accreditation Compliance

Waiver

CMS CLIA database 06/2013

Pro

Source:

How COLA’s Accreditation Process Works

STEP 1

STEP 2

STEP 3

STEP 4

STEP 5

Enrollment

Self-Assessment

On-Site Survey

Post-Survey &Corrective Action

Accreditation

STEP 1 - ENROLLMENT

•LaboratoryjoinsCOLAandreceivesinformation

packetandmanual.

•Laboratoryinformstheirproficiencytesting

providertoreleaseresultstoCOLAforongoing

monitoring.

•LaboratoryreceivesfullaccesstoallofCOLA’s

signatureeducationaltoolsandservices,

includingCOLAcentral,adesktopmanagingtool.

•Laboratorysubmitsdemographicinformationto

COLA(CLIA#,Personnel,TestsandTestMenu,

Instruments,AnnualTestVolume,etc.)

STEP 2 - SELF-ASSESSMENT

•LaboratoryconductsSelf-Assessmentand

submitstheinformationtoCOLA.

•Laboratorymakesimprovementsneededto

complywithallCOLAcriteria.

STEP 3 - ON-SITE SURVEY

•COLAsurveyorperformson-sitesurvey.

•COLAsurveyorsharespreliminarysurveyfindings

andprovideseducationalguidance.

STEP 4 - POST-SURVEY & CORRECTIVE ACTION

•COLAcarefullyanalyzessitedataandissuesformal

post-surveyreport.

•Ifnoncompliantcriteriaareidentified:

-COLAmakeseducationalmaterialsavailableto

thelabatnocost.

-COLA’stechnicalstaffprovideshands-on

consultation,supportandadvice.

•Labdevelopsandactsuponcorrectiveplan,

providingCOLAwithappropriatedocumentation.

STEP 5 - ACCREDITATION

•LaboratoryreceivesCOLAAccreditationCertificate

(validfortwoyears).

•COLAfollowslabperformanceonacontinuing

basis,includingmonitoringproficiencytesting.

•LaboratorycanuseCOLAcentraltohelpthemstay

indaily(ratherthanbiennial)compliancewithCLIA

andCOLAqualityrequirementsandallappropriate

statelicensurestandards.

•COLA’sQualityAdvisorshelplaboratoriesworkto

achieveazerocitationcultureinbetweenbiennial

surveys.

COLA .ORGCOLA .ORG

Accreditation Education Innovation

Why ISO Certifi cation MattersCOLA IS THE FIRST AND ONLY CMS-DEEMED ACCREDITOR TO ACHIEVE COVETED DESIGNATION

COLAsurveysnearly8,000clinicallabsacrossthecountry,helpingthemmeetifnotexceedCLIAstandards

throughitsindustry-leadingprogramofvoluntaryeducation,consultation,andaccreditation.

Buttheonlywaytobethebestistohaveitindependently

verified.That’swhyCOLA’sboardopenedtheorganization

uptothesametypeofrigorous,third-partyreviewit

routinelydeliverstoclients.

COLApursuedandreceivedcertificationunderISO’s

9001:2008standardaffectingqualitymanagementsystems.

COLA’scertificationcoversalldeliveryandadministration

activitiesforitsaccreditationprogram.

WinningISOrequiredCOLAtoembraceasignificantchangeinculture,andtorededicateitselftoitsmission

atafundamentallevel.Teammemberslearnedtolookformistakesandembracetheopportunitytofix

them.Asaresult,theyimprovedCOLA’sabilitytodelivervaluetoclients.

Inpreparationfortheaudit,allCOLA’sactivities–customerinteraction,systeminnovation,technical

training–werescrutinized.WhileremainingCLIAcompliant,COLA’spoliciesandprocedureswere

alignedwithmorestringentISOstandardsaffectingqualitymanagementsystems.

Aftertheauditorarrived,theprocessincludedover20hoursoftheauditorobservinghowCOLA’steam

membersperformtheirwork.Fromobservingasurveyorinactiontowatchingtechnicaladvisorsreviewing

paperworkandschedulinglaboratoriesforon-sitesurveys,everykeyprocesswasthoroughlyreviewed.

ByachievingISOcertification,COLAdemonstratesthatitisthebestofthebestamongaccreditors.Itenhances

itsabilitytoprotectpatientsafetybypromotinglabexcellence.Anditdemonstratesacommitmenttothekind

ofcontinuousapproachtoqualityassuranceitadvocatestothelabsitserves.

The International Organization for

Standardization (ISO) has developed

over 18,500 International Standards on a

variety of subjects and some 1,100 new

ISO standards are published every year.


COLA .ORGCOLA .ORG

COLA Case Study: One Lab’s Turn-Around StoryCOLAishelpinglaboratoriesmoveawayfromamindsetfocusedonbiennialsurveys,andtowardsone

whichemphasizesmakingqualityadaily,livingconcern.Tothatend,COLA’snewsubsidiary,COLA

Resources,Inc.®,anditstwoCOLAQualityAdvisorsrecentlyplayedabigroleinalabturnaround.

Asmallphysician’sofficelaboratory,locatedinthenorth

easternregionoftheUS,hadbeeninoperationfor

approximatelyeightmonths,performingtoxicologytesting.

CRI®wascontactedbythelaboratory,requestingan

objectiveauditbeperformedtoensurealllaboratorypolicies

andproceduresadheredtoregulatoryrequirements,foran

upcomingaccreditationsurvey.Anonsiteauditscheduled

andwasperformedbyoneofCRI®’sCQAs.Duringtheon-site

audit,itwasdiscoveredtherewerenoPolicyandProcedure

Manualsinplace;CompetencyTestingforlaboratory

personnelwasnotimplemented,andthelaboratorystaff

assumedalltestingperformedintheirlaboratorywas

moderatelycomplex.

FINDINGS:alltestingperformedintheirlaboratorywashighcomplexity,notmoderatecomplexity.Asa

result,neitherlaboratorypersonnelnorthelabdirectorwasqualifiedtoperformthetesting.Ifthe

laboratorydirectorwantedtocontinuetestinginhislaboratory,hefacedtwooptions:purchaseanew

instrument(moderatecomplexity),orhirenewpersonnel(forhighcomplexity).

DuetotheauditperformedbytheCQA,thelaboratorywasabletotakeimmediatestepstoensuretheycould

continuetooperatebyhiringnewqualifiedpersonnel,andtheybegandevelopingandimplementinggeneral

LaboratoryPolicyandProceduremanuals.Thelaboratoryisnowinapositiontobecomeregulatory

compliant,havingqualifiedpersonnelperformthetesting,withperiodiccompetencyassessmentperformed.

Outcome:thelaboratorywillprovideimprovedpatientcarethroughimprovedlevelofqualityservice.


COLA .ORGCOLA .ORG

Due to the audit performed by the CQA,

the laboratory was able to take

immediate steps to ensure they could

continue to operate by hiring new

qualifi ed personnel, and they began

developing and implementing general

Laboratory Policy and Procedure manuals.

COLA’s Surveyors: The Best of the BestWhenitcomestoprotectingpatientsafetyandpromotinglaboratoryexcellence,COLAworkshardtobethe

best.Butbeingthebestmeansawillingnesstorecruitandretaintheverybestteam.Thatcommitmentto

excellenceinhiringisespeciallyevidentamongthemembersofCOLA’ssurveyorteam-menandwomen

whoserveaslabqualityambassadorstoCOLAclients

acrossNorthAmerica.

COLA’ssurveyorsknowtheirwayaroundalabbench.That’s

becausetheyarelaboratoryveteransthemselves.Eachisa

certifiedmedicaltechnologistwithatleastsixyears’lab

experienceearnedbeforetheyevencametoCOLA.Each

alsoholdsatleastabachelor’sdegreeinarelevant

scientificdiscipline.Eachunderstandsthelaboratory

culture,andtheimportanceofadheringtobestpractices

andprocessesinordertoensurequalityisachievednotjust

everytwoyears,buteveryday.

Further,COLAsurveyorsaretrainedtominimizetheroleof

subjectivityinthesurveyingprocess.Throughtheprincipleof“inter-raterreliability,”COLAensuresthat

surveyorssentintothesamelabondifferentoccasionswilleachrecognizethesamequalityissueswhen

theyseethem.

Whenitcomestoperformingtheirduties,COLA’ssurveyorsoperatestrictlybythebook.Butwhenthey

identifyanareainwhichalabisnon-compliantwithCLIAorstatelicensurestandards,theyandother

membersofCOLA’stechnicalteamwillworkconstructivelywiththelabs’stafftohelpfindapermanent

solution.Theyfunctionasnecessaryifsometimescriticalpartners,notadversaries.

And,COLAcontinuestoleveragetechnologytoenhancesurveyors’abilitytodelivervaluetocustomers.

Forexample,COLA’spaperless“Eval”systemhelpssurveyorsperformtheirdutiesinafaster,moreefficient,

environmentallyfriendlymanner,allowingthemtogiveclientspreliminary,on-the-spotsurveyresults.

COLA’s 26 surveyors serve more than

7,000 labs across the United States as

well as in Canada, Bermuda, and Virgin

Islands. One of COLA’s surveyors

performed 300 surveys in a single year.

COLA .ORGCOLA .ORG


COLA’s Culture of InnovationPushingthetechnologicalenvelopeisoneofCOLA’shallmarks.Whethergivingsurveyorsthecapability

togiveclientsimmediateresults,orenablinglabprofessionalstomanageregulatorycompliance

requirementselectronically,weunderstandthatembracingnewtechnologiesandeverbetterwaysof

doingbusinesssharpensourabilitytodelivervaluetoclients.

LINQ:COLA’sproprietarydatabasetoolallowsittostay

connectedwitheverylabitserves.ItgivesCOLA’sstaff

immediateaccesstofactsaboutthelab’shistory,itsstaff,

itsCLIAcertificatestatus,andothercriticalinformation.

COLAcentral: COLA’sonlineportalhelpslabsremainin

dailyratherthanbiennialcompliancewithlabquality

standards.Itgivesclientsthetoolsandeducationneededto

preventrepeatcitations,keepstaffcompliantwithCLIA,

COLA,andapplicablestatestandards,storedocuments,and

performothercriticalmanagementtasks.Italsoenhances

communicationsbyallowinguserstouploaddocuments

directlytoCOLAandviewcommunicationssenttothelab.

COLA’snewestlearningtoolisdesignedtohelpphysicianofficeandhospitallaboratoriesperformcost/

benefitanalysesonawidearrayoflabtests.LabClarityenableslabmanagerstoevaluatediffering

scenariossuchasproceduremethodologies,personnelutilization,andreimbursementfees,tobetter

understandthecosteffectsoftesting,therebyimprovingoperationalefficiency.

VIRTUAL OFFICE ENVIRONMENT:COLAempowersclientsandstakeholdersalikethroughaseamless,

convenient,user-friendly,virtualcommunicationssystemwhichmakesitjustaseasytoreachpeopleinthe

fieldasitdoesatCOLA’sheadquarters.Simplyput,peoplewhocallCOLAhaveaneasiertimeconnecting

quicklywiththepersontheyneedbecauseofitsnew,state-of-the-artsystem.

EVAL:COLA’snewproprietarysurveysystemispaperlessanddoesn’trequirealiveInternetconnection.

Thedatacannowberecordedinthefieldandeasilyuploadedlater.And,itallowssurveyorstogivelabs

preliminary,on-the-spotresultsafterthesurveyiscomplete.Surveyorsthereforeareabletorefocustime

oncespentondataentryoneducatinglabstaffinthefield.

ONLINE LEARNING:COLAwebinarsaddressingtimelyandrelevanttopicsarepresentedsixtimesayear.

Onaverage,90-98%ofparticipantssaytheywouldrecommendtheCOLAwebinarprogramtoothers.

AndCOLA’sLabUniversityprogramisundergoingadramaticexpansion.Seventyrevisedcourseswillbe

deliveredonthebestprogramavailable,ensuringclientshavethebestonlinelearningexperiencepossible.

Byleveragingexistingtechnologiesaswellasdesigningitsownproprietarysolutionstobenefititsclients,

COLAcontinuestobethebestofthebestamongaccreditingorganizations.

COLA .ORGCOLA .ORG

COLAcentral’s fl exible platform,

maintained by dedicated support staff,

provides COLA opportunities to add

other value-added features, such as a

new competency assessment tool for

lab staff.


COLA: Making Lab Quality a Living ConcernTheClinicalLaboratoryImprovementAmendmentsof1988(CLIA88)isthefederallawintendedtoensure

theaccuracy,reliability,andtimelinessofpatienttestresults.TomaintaintheirCLIAcertification,labs

whichperformanythingmorecomplexthanwaivedtestingorprovider-performedmicroscopymustbe

surveyedeverytwoyearsbyeitherCMSoraprivate

accreditingorganizationlikeCOLA.Additionally,California

andseveralotherstatesrequiresurveysaspartoftheirown

licensurerequirements.

Biennialsurveyingpresentsasnapshotofqualityatany

givenlab.Therealchallengeistohelplaboratorians

integratequalitypoliciesandproceduresintotheirdaily

lives.That’swhyCOLAishelpingitsclientsmovebeyond

thesnapshotandtowardsamindsetemphasizingdaily,

continuouscompliancewithCOLA’sownrigorous

qualityguidelines.

COLAoffersthefollowingtoolsandservicestohelpclients

makequalityapermanentpartofthelabculture.

Toassistlaboratoriesinframingtheirproperroleinemergingnewhealthcaredeliverymodels,COLA

recentlyintroducedanewrecognitionprogram,calledPatientCenteredLaboratoryExcellence(PCLE)which

emphasizesgoodlaboratorypracticesaboveandbeyondcurrentregulatoryrequirementsforall

laboratoriesregardlessoftheirCLIA-designatedcomplexity.PractitionersusingtheservicesofaCOLAPCLE-

recognizedlaboratorycanbeassuredofhighqualityresults,generatedbywelltrainedstaffwhousestate-

of-the-artcommunicationstodeliverenhancedaccesstoresultstobothpatientsandproviders.

•TECHNOLOGY:COLAcentral,COLA’sonlineportal,givesclientseverydayaccesstotheresourcesneededto

preventrepeatcitations,keepstaffcompliantwithCLIA,COLA,andapplicablestatestandards,teststaff

competency,storedocuments,andperformothercriticalmanagementtasks.

•CONSULTATION:COLA’sprofessionalsareavailabletoitsclientsthroughmonthlyandindividualtraining

sessions,yearlyinpersongatherings,webinarsandLabUniversityclasses.COLA’stwoQualityAdvisors,who

helpmakequalityadailylivingconcerninthelaboratoriestheyserve,areonlyaphonecallaway.

Patientsdonotthinkofqualityinsnapshotterms.NeitherdoesCOLA.Byhelpingitsclientstreatqualityasa

continuous,holisticconcern,COLAishelpingthembetterprotectpatientsafetybyembracinglabexcellence.

COLA .ORGCOLA .ORG

Among private accreditors, COLA prides

itself on being the best of the best. One

of the ways it achieves that is by

advocating on behalf of lab quality

standards which go beyond what is

required under CLIA or state law.


DOUGLAS A. BEIGEL ChiefExecutiveOfficer

Email:[email protected]

RICHARD CROSSGovernmentRelations

&ExternalAffairsManager


ROBERT FRENCHChiefCounsel


TAMMY ZINSMEISTER ChiefInnovationOfficer


COLA, INC. (HEADQUARTERS)9881BrokenLandParkway,Suite200

Columbia,Maryland21046-1195

MainLine:410-381-6581

TollFree:800-981-9883

TO LEARN MORE ABOUT COLA, VISIT:

www.cola.org

(COLA’s corporate website)

Key COLA Contacts:

Documents

Accreditation Education Innovation - COLA€¦ · Accreditation Education Innovation COLA.ORG Due to the audit performed by the CQA, the laboratory was able to take immediate steps