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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.
Accreditation Education Innovation
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.
Accreditation Education Innovation
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
Accreditation Education Innovation
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.
Accreditation Education Innovation
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.
Accreditation Education Innovation
DOUGLAS A. BEIGEL ChiefExecutiveOfficer
Email:dbeigel@cola.org
RICHARD CROSSGovernmentRelations
&ExternalAffairsManager
Email:rcross@cola.org
ROBERT FRENCHChiefCounsel
Email:rfrench@cola.org
TAMMY ZINSMEISTER ChiefInnovationOfficer
Email:tzinsmeister@cola.org
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:
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