the cap inspection and accreditation program at age 50 - American ...

THE CAP INSPECTION ANDACCREDITATION PROGRAM ATAGE 50Twenty Years of CLIA ‘88 by College of AmericanPathologists (CAP).April 20, 2012ASCLS-NE – CLMA – ASCP Spring MeetingLa Vista, NebrsakaRichard J. Baltaro, MD, PhD, FCAPPathology DepartmentCreighton University School of MedicineOmaha, Ne 68131 USACME Objectives: At the end of the presentationthe participant should be able to:1) Describe the relationship of CAP (College ofAmerican Pathologists) 15189 to CAP LAP(Laboratory Accreditation Program).2) Recognize the similarities and differencesbetween laboratory accreditation and laboratoryinspection.3) Identify some of the advantages of a processimprovement system that utilizes practicinglaboratory professionals, rigorous standards andchecklists.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.Disclosure of financial interest/arrangement or affiliation thatwould be considered a conflict of interest.Acknowledgments:Dr Baltaro would like to Thank for the invaluable aid for this presentation:Grants / Research SupportOtherLilly Co. & Streck, Inc.,CAP internationallaboratory inspectorWilliam J. Castellani, MD, FCAPProfessor of PathologyPenn State Hershey Medical CenterHershey, PAInter-Regional Commissioner, CAPOpinions expressed are Dr. Baltaro’s personal opinions NOT ofCreighton University, Creighton University Medical Center, VeteransAdministration (VA) or the College of American Pathologists (CAP).R. Bruce Williams, MD, FCAPThe Delta Pathology Group, LLCShreveport, LAFormer Chair, Commission on Laboratory Accreditation, CAPEvery number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.Who Accredits Labs in the US?In US, the clinical laboratories are among the most highlyregulated healthcare entities; many laboratory practicesare the direct result of federal or state/local legislation.Understanding these laws is necessary to avoid legal oradministrative repercussions that may limit a laboratory'soperations or shut it down completely.To operate (and receive reimbursement for services),laboratories must be licensed and may also need to beaccredited.Licensure is mandatory; it is a federal and/or staterequirement to operate a laboratory.Accreditation is voluntary, though it may satisfy licensurerequirements in some states.McPherson & Pincus: Henry's Clinical Diagnosis andManagement by Laboratory Methods, 21st ed.Every number is a life.Chapter 1 Regulation, Accreditation, and Legislation©2008 College of American Pathologists. All rights reserved.AccreditationDefinition : Accreditation is a process in which certificationof competency, authority, or credibility is presented.In systems engineering accreditation is the formal attestationthat a model or simulation is acceptable for use for aspecific purpose.Accreditation is conferred by the organization best positionedto make the judgment that the model or simulation inquestion is acceptable.That organization may be an operational user, the programoffice, or a contractor, depending upon the purposesintended.©2008 College of American Pathologists. All rights reserved.Every number is a life.1

Table 1-10 -- CLIA ‘Deemed Status’StatesNew YorkWashingtonOrganizationsCollege of American Pathologists (CAP)Joint Commission on Accreditation of Health CareOrganizations (JCI)American Association of Blood Banks (AABB)American Society for Histocompatibility andImmunogenetics (ASHI)Commission on Office Laboratory Accreditation (COLA)American Osteopathic Association (AOA)Table is from Todd & Sandford text©2008 College of American Pathologists. All rights reserved.Every number is a life.8Figure 6-1 A, The number of POLs inAugust of 2004 relative to hospital,skilled nursing facilities, andindependent laboratories. B, Relativeproportion of registered laboratoriesby certification type. (from the CMSCLIA Database, August, 2004 athttp://www.cms.hhs.gov/clia/statreg.pdf) (from the CMS CLIA Database,Every number is a life.August, 2004)CAP - It Started Long Ago - 1949CAP History Timeline1961 - Ad Hoc Committee on LaboratoryAccreditation submits report recommendingestablishment of accreditation program.1962 - CAP Inspection and Accreditation Programestablished.1965 - First laboratory accreditation checklistcompiledAccess Your Custom and Master Checklists©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.CAP History Timeline1967 - Proficiency testing participation becomes arequirement for accreditation programClinical Laboratories Improvement Act of 1967 passedJCAH adopts CAP laboratory accreditation standards1969 - Inspection & Accreditation Program declaredequivalent to CLIA-67 standards by HCFAInspector ARE BORN!!! --Inspectors are Born!In government & politics, an inspection is the act of amonitoring authority administering an official review ofvarious criteria (such as documents, facilities, records,and any other assets) that are deemed by the authority tobe related to the inspection.Inspections are used for the purpose of determining if abody is complying with regulations.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.2

Medical LaboratoryAccreditationMedical LaboratoryAccreditationBased onISO 15189NOSince1970 Since1968Since1990Since1979 Since2003Since2005Since2010SinceNO2011 NODevelopedusingISQuamodelDeveloped withreference to ISO15189Every number is a life.Every number is a life.European Union rules that one country has onlyone national accreditation body, ISO 15189 basedFrance: According the decision of Ministry of Health all clinicallabs must be accredited (ISO 15189) by COFRAC (NationalAccreditation Body) to the end of 2010.United Kingdom: CPA/UKAS partnership developed in 1996& CPA standards were incorporating ISO 15189requirements & the future development of accreditationticonsider the use of ISO 15189.Germany: quality requirements on the basis ISO 15189.Accreditation is still performed voluntarily and around 20%of labs are accreditedItaly: the ISO 15189 is considered to be the referencestandard for accreditation, but the accreditation bodydedicated to clinical laboratories does not exit.Smart Open Services for EuropeanPatients = epSOS projectAims to promote free movement of patients. Is toallow health professionals to electronically accessthe data from patients from another country, toelectronically process prescriptions in all involvedcountries, or to provide treatment in another EUstate to a patient on a waiting list.The project has been launched by the EU and 47member institutions from 23 EU memberstates & 3 non-EU members.Every number is a life.Every number is a life.Healthcare and Hospital Accreditation WorldWHO hospital accreditation worldwide. 1941 WHO started accrediting.ISO is perceived as an accrediting agency. 1947 ISO started.In the USA, Canada, the UK, Australia, New Zealand and othercountries sophisticated accreditation groups have grown up to surveyhospitals.USA - Joint Commission International (JCI). 1951 JCH began.Canada - Accreditation Canada CCHSA.United Kingdom:- Trent Accreditation Scheme.Australia:- ACHSINew Zealand:- Quality Health New Zealand.More Alphabet Soup of AccreditationINDIA:- National Accreditation Board for Hospitals &Healthcare Providers.QHNZ quality standards are based on those used in Australia& Canada. QHNZ is accredited by the internationalumbrella organization.The International Society for Quality in Healthcare (ISQua).ISQua is the same umbrella organization responsible foraccrediting the Joint Commission International (JCI)accreditation scheme in the USA and the Canadian Councilon Health Services Accreditation, as well as accreditationorganizations in the United Kingdom and Australia.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.5

Who Else Accredits laboratories world wide ?NATA (Australia)IANZ (New Zealand)The Korean Laboratory Accreditation Program(KLAP)HOKLAS (Hong Kong)STANDARDS MALAYSIA (Malaysia)CAP (USA) -- YES even CAP!!!Everynumberis a life.The CAP logofamiliar to us USlaboratoriansHave you heard ofISO CAP 15189 ?©2008 College of American Pathologists. All rights reserved.Every number is a life.www.cap.orgWhat is ISO 15189?Everynumberis a life.CAP 15189The CAPImplementation ofAccreditation to the ISO15189 standardISO 15189 is an international standard for medicallaboratories• Paper standards are guidance documents to the state of the art ina specific discipline i or technical area• They do not have the force of law/regulation except in thosecountries that adopt the standards as requirementswww.cap.org©2008 College of American Pathologists. All rights reserved.Every number is a life.The International Organization for Standardization (Organizationinternationale de normalisation), widely known as ISO, is aninternational-standard-setting body composed of representatives fromvarious national standards organizations.Founded in 1947, the organization promotes worldwide proprietaryindustrial and commercial standards.It has its headquarters in Geneva, Switzerland.ISO defines itself as a non-governmental organization, its ability to setstandards that often become law, either through treaties or nationalstandards, makes it more powerful than most non-governmentalorganizations.ISO has strong links to governments.Geneva is a worldwide center for diplomacy and internationalco-operation, and is widely regarded as a global city, mainlybecause of the presence of numerous internationalorganizations, including the headquarters of many of theagencies of the United Nations (e.g. WHO) and the RedCross.It is also the place where the Geneva Conventions weresigned, which chiefly concern the treatment of wartime noncombatantsand prisoners of war.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.6

Geneva, SwitzerlandGeneva has been described as the world's sixth mostimportant financial center by the Global FinancialCenters Index, ahead of Tokyo, Chicago, Frankfurtand Sydney*, and a 2009 survey by Mercer foundGeneva to have the third-highest quality of life inthe world (outranked by Vienna & Zurich).The city has been referred to as the world's mostcompact metropolis and the "Peace Capital".* 1) London 2) New York 3) Hong Kong 4) Singapore 5) Shenzhen, ChinaEvery number is a life.©2008 College of American Pathologists. All rights reserved.memberscorrespondent memberssubscriber membersother places with an ISO 3166-1 code who aren't members of ISOEvery number is a life.©2008 College of American Pathologists. All rights reserved.World Health Organization (WHO)The World Health Organization (WHO) is a specializedagency of the United Nations (UN) that acts as acoordinating authority on international public health.Established in 1948, and headquartered in Geneva,Switzerland, the agency inherited the mandate andresources of its predecessor, the Health Organization,(1919-1948) which had been an agency of the League ofNations (which the US was never a member).Several international agencies are headquartered atGenevaInternational Federation of Red Cross and Red CrescentSocieties (IFRC),International Committee of the Red Cross (ICRC).World Trade Organization (WTO)International Labor Organization (ILO)World International Property Organization (WIPO)World Economic Forum (WEF)United Nations High Commissioner for Refugees (UNHCR),United Nations High Commissioner for Human Rights(UNHCHR)©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.Jean Henri Dunant (1828 - 1910)Was a Swiss businessman and social activist.During a business trip in 1859, he was witnessto the aftermath of the Battle of Solferino inmodern day Italy.He recorded his memories and experiences inthe book A Memory of Solferino which inspiredthe creation of the International Committeeof the Red Cross (ICRC) in 1863.The 1864 Geneva Convention was based onDunant's ideas.In 1901 he received the first Nobel Peace Prizetogether with Frederic Passy (a Frencheconomist and pacifist).©2008 College of American Pathologists. All rights reserved.Henri Dunantin 1860Every number is a life.International Federation of Red Cross andRed Crescent SocietiesUp until the middle of the 19 th century, there were noorganized and well-established army nursingsystems for casualties and no safe and protectedinstitutions to accommodate and treat those who werewounded on the battlefield.In June 1859, the Swiss businessman Henry Dunanttraveled to Italy to meet French emperor Napoleon IIIwith the intention of discussing difficulties inconducting business in Algeria, at that time occupiedby France.In a single day, about 40,000 soldiers on both sides diedor were left wounded on the field.Dunant was shocked by the terrible aftermath of thebattle, the suffering of the wounded soldiers, & theHenri Dunantnear-total lack of medical attendance & basic care©2008 College of American Pathologists. All rights reserved.Every number is a life.7

Every number is a life.Every number is a life.ISO 15189:2007Medical laboratories – Particular requirements forquality and competenceWritten by Work Group 1 of TC 212Every number is a life.A long, arduous gestation• Originally proposed in final form in 1999• Challenged by TC 176, Quality Management andQuality Assurance• Question of overlap with ISO 17025, GeneralRequirements for the Competence of Testing andCalibration Laboratories©2008 College of American Pathologists. All rights reserved.Every number is a life.ISO Evolution of Quality Management StandardsRelationship of ISO 9001 to ISO I5189IndustryQMS CertificationISO TC 176ISO CascoCalibrationLaboratoryISO TC 212ClinicalLaboratoryAccreditationMedicalLaboratories-ParticularrequirementsFor quality andcompetence.9001• Best fits generic client/ providerarrangements• Example:Manufacturingindustry15189• Designed specificallyfor clinical and medicallaboratories• Developed throughinternationalconsensus amongclinical and medicalexpertsAccreditationand CalibrationLaboratoriesTesting©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.8

Relationship of CAP I5189 to CAP LAPRelationship of 15189, Lean, & Six Sigma15189• Voluntary in U.S.• Focus on overallquality system• Goal is failureresistant system• Scope goes beyondlabCAP LAP• Based on CLIA(CLIA required inU.S. not CAP)• Focus on technicalprocedures• Goal is valid currentpractices• Scope focused on labISO – overarching quality management systemLean, Six Sigma – specific methodologies used within qualitymanagement system• Lean:• Designed to reduce waste• Developed by automotive industry (Toyota)• Six Sigma –• Designed to reduce production defects• Developed by Motorola©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Sakichi Toyoda (1867 - 1930豊 ⽥ 佐 吉 ) was a Japanese inventor andindustrialist.Every number is a life.Management RequirementsManagement Requirements4.1 Organize and staff thelab so it can support aQMS (Quality ManagementSystem).• Have a manager whocan focus on quality,versus fighting brushfires.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.Management RequirementsManagement Requirements4.2 Create a complete QMS,(Quality ManagementSystem) including• Resources / infrastructure• Documentation (based on analysis of work)• Goals & metrics• Quality activities – internal audit, corrective action,management review, training, etc.4.4 Scrutinize contracts. Don’t take work you can’t do.4.5 Scrutinize referral labs; proactively assess their quality.4.6 Proactively assess quality of suppliers. Control yourinventory.4.3 Control your documents so tasks are done in aconsistent, accurate manner.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.9

Management Requirements4.7 Make sure there iscommunication betweenlab director and clinicians.Management Requirements4.8 Take complaints seriously. Contain problems, analyzetheir causes, and prevent future problems.4.9 Insure that lab has resources and plans to resolve qualityissues, even those that haven’t yet affected patients.4.10 Take corrective action based on root cause. Focus onproblem causes, not the person.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.Management RequirementsManagement Requirements4.11 Analyze data and look for things that could gowrong. Prevent mistakes.4.12 Challenge existing metrics and goals. Continuallylook for better ways to do the work.4.13 Make sure your records are managed so you canquickly access data to reconstruct what hashappened in the past.4.14 Self-evaluate against your own documentedprocesses and QMS.4.15 Continually review and document your qualityplans, initiatives, internal assessments, externalassessments & results. Make decisions based onfacts.©2008 College of American Pathologists. All rights reserved.Every number is a life.©2008 College of American Pathologists. All rights reserved.Every number is a life.Implementation RoadmapCAP Approach to ISO 15189Strategy & Planning QMS Development Audit MaintenanceQMSIdentifyIdentify goalsreadiness & Marketteamobjectives & metricseducationassessmentEtblih EstablishstakeholderMgmt.DevelopcommitmentDevelopimplementationDevelop & mapAssemble InternalReviewAppointCreateCorrectiveInternalquality policy,steering planCore processes Documentation quality Audit ActionAuditsobjectivesmanualReviewcommittee& metricsgoals &ChangerevisemanagementBuild supportmetricsstrategyfor processesSurveillance• Documentation• Training• CompetenciesCreate document & records control systemsConduct training on process mapping,process improvement, documentation©2008 College of American Pathologists. All rights reserved.Conduct training on internal audit,management review,root cause analysisEvery number is a life.No mandatory timeline• All assessments are announced with a defined agenda that is agreed toby the client• Schedules and site visits are coordinated and based on when the clientis ready3 Year Accreditation CycleCAP Assessors trained in ISO 15189, RABQSA (Registrar AccreditationBoard (RAB) & Quality Society of Australasia (QSA) in Sydney)• Account executive approach, supporting the client for all materialsand communications throughout the accreditation processEducational approach• CAP offers the unique opportunity for optional:• Introductory Visits• Gap Assessments• Pre Assessments©2008 College of American Pathologists. All rights reserved.Every number is a life.10

Thank you!Questions?©2008 College of American Pathologists. All rights reserved.Every number is a life.12