DoD Clinical DoD Clinical Laboratory Laboratory

Improvement Improvement Program Program

(DoD-CLIP)(DoD-CLIP)

Presented By:Presented By:

HMC Gerry S. Rapisura, USN, MT(ASCP)HMC Gerry S. Rapisura, USN, MT(ASCP)

Navy Program Manager, DoD-CLIPNavy Program Manager, DoD-CLIP

MSgt Gary Brown, USAFMSgt Gary Brown, USAF

Air Force Program Manager, DoD-CLIPAir Force Program Manager, DoD-CLIP

Center for Clinical Laboratory Medicine Center for Clinical Laboratory Medicine (CCLM)(CCLM)

Topics for DiscussionTopics for Discussion

• Overview of CCLMOverview of CCLM

• CLIP Program and certificatesCLIP Program and certificates

• CAP surveys and inspectionsCAP surveys and inspections

• CAP PT failuresCAP PT failures

• Useful websitesUseful websites

• Contact InformationContact Information

HistoryHistory• Clinical Laboratory Improvement Act of 1967Clinical Laboratory Improvement Act of 1967

– Applied only to laboratories involved in interstate Applied only to laboratories involved in interstate commerce.commerce.

– Had little impact on the laboratory communityHad little impact on the laboratory community

• Adverse publicity regarding PAP smears and Adverse publicity regarding PAP smears and physician office laboratory testing (POL)physician office laboratory testing (POL)

• Response of Congress (amends PL 100-578)Response of Congress (amends PL 100-578)– The Clinical Laboratory Improvement Amendments of The Clinical Laboratory Improvement Amendments of

1988 1988 – Published March 1992Published March 1992

• Included Federal Facilities (DOD facilities not Included Federal Facilities (DOD facilities not exempt)exempt)

CLIA'88CLIA'88• Purpose: Purpose: To improve the quality of any To improve the quality of any

testing conducted for medical testing conducted for medical purposes.purposes.

• Broadly applicable: Congress required Broadly applicable: Congress required every testing site examining every testing site examining “materials “materials derived from the human body for the derived from the human body for the purpose of providing information for purpose of providing information for the diagnosis, prevention, or treatment the diagnosis, prevention, or treatment of any disease…”of any disease…” to be regulated. to be regulated.

CLIA'88CLIA'88

• Revised and superseded CLIA'67Revised and superseded CLIA'67

• The Centers for Medicare &/Medicaid The Centers for Medicare &/Medicaid Studies (CMS) provides oversight for the Studies (CMS) provides oversight for the programprogram

• Incorporated four separate sets of rules Incorporated four separate sets of rules for implementationfor implementation

• DOD allowed to develop separate plan DOD allowed to develop separate plan with certain restrictionswith certain restrictions

History History Clinical Laboratory Clinical Laboratory

Improvement Program (DoD-Improvement Program (DoD-CLIP)CLIP)

• Meeting of representatives from the three Meeting of representatives from the three services to draft original plan from CLIA 88 - services to draft original plan from CLIA 88 - Code of Federal Regulations in April 1992Code of Federal Regulations in April 1992

• DOD Clinical Laboratory Improvement DOD Clinical Laboratory Improvement Advisory Committee met in Washington DC Advisory Committee met in Washington DC from 20-23 July 1992 and developed final from 20-23 July 1992 and developed final draft of CLIP.draft of CLIP.

• Coordinated through Service Surgeon Coordinated through Service Surgeon Generals on 29 September 92Generals on 29 September 92

DOD ProgramDOD Program• To be called Clinical Laboratory To be called Clinical Laboratory

Improvement Program (DoD-CLIP). Improvement Program (DoD-CLIP). – AFIP PAM 40-24 – DOD-CLIP ProgramAFIP PAM 40-24 – DOD-CLIP Program

• Very much like CLIA with certain Very much like CLIA with certain exceptions to meet military exceptions to meet military operational requirements.operational requirements.

• Office of Clinical Laboratory Affairs Office of Clinical Laboratory Affairs (OCLA), Center for Clinical Laboratory (OCLA), Center for Clinical Laboratory Medicine (CCLM) in AFIP staffed by Medicine (CCLM) in AFIP staffed by tri-service personnel and provides tri-service personnel and provides oversight for the program.oversight for the program.

Registration Required for all Registration Required for all DoD Clinical Testing SitesDoD Clinical Testing Sites

• Based on complexity of testingBased on complexity of testing– Minimally Complex (Waived)Minimally Complex (Waived)– ModerateModerate

•Provider-Performed Microscopy (PPM)Provider-Performed Microscopy (PPM)

– HighHigh

• Currently have 1251 certificates Currently have 1251 certificates issued with 2471 testing sitesissued with 2471 testing sites

Complexity DefinitionsComplexity Definitions• MinimalMinimal Complexity (Waived) tests are Complexity (Waived) tests are

those laboratory examinations and those laboratory examinations and procedures that employ accurate but procedures that employ accurate but simple methodologies (mostly FDA simple methodologies (mostly FDA approved home tests)approved home tests)

• ModerateModerate Complexity tests are those Complexity tests are those defined as moderate complexity by the defined as moderate complexity by the Centers for Medicare & Medicaid Centers for Medicare & Medicaid Studies (CMS) and published by the Studies (CMS) and published by the Center for Disease Control (CDC)Center for Disease Control (CDC)

Complexity DefinitionsComplexity Definitions• HighHigh Complexity tests are those Complexity tests are those

defined as high complexity by CMS and defined as high complexity by CMS and published by CDC (also includes non-published by CDC (also includes non-FDA approved procedures)FDA approved procedures)

• Any deviation from the manufacturers Any deviation from the manufacturers instructions automatically classifies a instructions automatically classifies a test as high complexitytest as high complexity

• CDC Web site lists all tests by CDC Web site lists all tests by complexitycomplexity((www.fda.gov/cdrh/CLIA/index.htmlwww.fda.gov/cdrh/CLIA/index.html))

Program RequirementsProgram Requirements• Personnel Standards - Personnel Standards - Defined for each category Defined for each category

of testing (director, clinical consultant, technical of testing (director, clinical consultant, technical consultant, general supervisor, and testing personnel)consultant, general supervisor, and testing personnel)

• Quality Control (QC) - Quality Control (QC) - monitors the actual monitors the actual analytical testing processanalytical testing process

• Quality Assurance (QA) - Quality Assurance (QA) - all phases of the all phases of the testing process are monitoredtesting process are monitored

• Procedure Manuals - Procedure Manuals - meeting National meeting National Committee for Clinical Laboratory Science (NCCLS) GP2-Committee for Clinical Laboratory Science (NCCLS) GP2-A3 formatA3 format

Program RequirementsProgram Requirements• Patient Test Management Process Patient Test Management Process

(Pre, Analytical, Post)(Pre, Analytical, Post)

• Proficiency Testing - Mandatory for Proficiency Testing - Mandatory for PPM, moderate and high complexity PPM, moderate and high complexity sites (even for waived sites, test sites (even for waived sites, test accuracy must be verified at least accuracy must be verified at least twice annually)twice annually)

• Inspections and Sanctions - testing Inspections and Sanctions - testing privileges are suspended or revoked privileges are suspended or revoked for facilities out of compliancefor facilities out of compliance

Overview of DoD CLIP Overview of DoD CLIP RequirementsRequirements

Type of LaboratoryType of Laboratory

Minimal ComplexityMinimal Complexity

Moderate ComplexityModerate Complexity– PPMPPM

High ComplexityHigh Complexity

RequirementsRequirements

Registration and good Registration and good laboratory practicelaboratory practice

QC, QA, PT, Limited QC, QA, PT, Limited Personnel, Personnel, AccreditationAccreditation

QC, QA, PT, Stringent QC, QA, PT, Stringent Personnel, Personnel, AccreditationAccreditation

Accrediting Organizations Accrediting Organizations (Deemed Status)(Deemed Status)

• Joint Commission on Accreditation of Joint Commission on Accreditation of Healthcare Organizations (JCAHO)Healthcare Organizations (JCAHO)

• College of American Pathologists (CAP)College of American Pathologists (CAP)– Army, Air Force and Navy has a centralize Army, Air Force and Navy has a centralize

contract for PT and Accreditationcontract for PT and Accreditation• Commission on Office Laboratory Commission on Office Laboratory

Accreditation (COLA)Accreditation (COLA)

• Certain States also have deemed statusCertain States also have deemed status• Etc.Etc.

Registration ProcessRegistration Process

• Registration: Registration: http://http://www.afip.org/OCLAB/index.htmlwww.afip.org/OCLAB/index.html– Initial snapshot of facilityInitial snapshot of facility– Type of laboratory (complexity)Type of laboratory (complexity)– Director, by nameDirector, by name– List of personnel and educationList of personnel and education– Test volume and methodologyTest volume and methodology

• Certificates are valid for two yearsCertificates are valid for two years

• Discuss in details on later Discuss in details on later presentation. presentation.

Types of CertificatesTypes of Certificates

• Registration CertificateRegistration Certificate

• Certificate for Minimal Complexity Certificate for Minimal Complexity TestingTesting

• Certificate for Provider-Performed Certificate for Provider-Performed Microscopy Microscopy

• Certificate of ComplianceCertificate of Compliance

• Certificates of AccreditationCertificates of Accreditation

DoD-CLIP LAP/PT FundingDoD-CLIP LAP/PT Funding• OCLA, CCLM centrally contracts for:OCLA, CCLM centrally contracts for:

– Accreditation inspection (LAP) costs for Accreditation inspection (LAP) costs for CAP accredited laboratoriesCAP accredited laboratories

– Proficiency testing (surveys) through CAP Proficiency testing (surveys) through CAP – Means CCLM will pay your LAP and PTMeans CCLM will pay your LAP and PT

• Non-CAP LAP and PT are self pay.Non-CAP LAP and PT are self pay.

• Nice to know: Not all CAP PT are funded Nice to know: Not all CAP PT are funded by CCLM. Check with your by CCLM. Check with your corresponding service Program corresponding service Program Manager for exemptionManager for exemption

QUESTIONSQUESTIONS

THANK YOU FOR LISTENING AND YOUR THANK YOU FOR LISTENING AND YOUR TIME TIME

DoD-CLIP, CCLMDoD-CLIP, CCLM

• Established with an MOA between Established with an MOA between the DoD and DHHSthe DoD and DHHS

• Purpose is to establish standards and Purpose is to establish standards and policy for implementation of quality policy for implementation of quality clinical laboratory testing within the clinical laboratory testing within the DoDDoD

DoD - Clinical laboratory Improvement DoD - Clinical laboratory Improvement ProgramProgram(CLIP) (CLIP)

What is it?What is it?

• Military equivalent of CLIA 88 (Clinical Military equivalent of CLIA 88 (Clinical Laboratory Improvement Amendments Laboratory Improvement Amendments of 1988)of 1988)

• Sets forth the minimum conditions Sets forth the minimum conditions that all laboratories must meet to be that all laboratories must meet to be certified to perform testing under the certified to perform testing under the DoD CLIPDoD CLIP

• Laboratories under DoD jurisdiction Laboratories under DoD jurisdiction are subject to the rules of this program are subject to the rules of this program

DoD-CLIP - ExceptionsDoD-CLIP - Exceptions

• During declared or undeclared wars, or During declared or undeclared wars, or period of mobilizationperiod of mobilization

• Testing for forensic purposes onlyTesting for forensic purposes only• Research laboratories that test human Research laboratories that test human

specimens, but do not report patient specimens, but do not report patient results for diagnosisresults for diagnosis

• Some laboratories performing drug testingSome laboratories performing drug testing• Medical laboratories assigned to field Medical laboratories assigned to field

medical units that perform limited human medical units that perform limited human testingtesting

• Navy Ship’s Laboratories Navy Ship’s Laboratories

CLIP - ComplexitiesCLIP - Complexities

Tests are categorized as one of the Tests are categorized as one of the following:following:

1.1. Minimal complexity (Waived)Minimal complexity (Waived)

2.2. Non-Waived Non-Waived – Moderate complexity, including Moderate complexity, including

subcategory provider performed subcategory provider performed microscopy (PPM)microscopy (PPM)

– High complexityHigh complexity

CLIP – Laboratories performing minimally complex CLIP – Laboratories performing minimally complex teststests

Definition of minimally complex:Definition of minimally complex:

• A test cleared by the FDA for home useA test cleared by the FDA for home use

• employs methodologies that are simple employs methodologies that are simple and accurate and accurate

• pose minimal risk of harm to the patient if pose minimal risk of harm to the patient if performed incorrectlyperformed incorrectly

• Laboratory qualifies for a certificate Laboratory qualifies for a certificate of minimal complexity if it restricts of minimal complexity if it restricts its tests to minimal complexityits tests to minimal complexity

• Sites with minimal complexity Sites with minimal complexity certificates are normally your certificates are normally your outlying point of care testing sitesoutlying point of care testing sites

• Examples: Urine HCG, fecal occult Examples: Urine HCG, fecal occult blood, urine dipstick, glucose, blood, urine dipstick, glucose, cholesterolcholesterol

CLIP – Laboratories performing minimally complex CLIP – Laboratories performing minimally complex teststests

• Laboratories eligible for a certificate Laboratories eligible for a certificate of minimal complexity must:of minimal complexity must:– Follow manufacturer’s instructionsFollow manufacturer’s instructions– Analyze and document controlsAnalyze and document controls– Ensure training and competency is Ensure training and competency is

documenteddocumented– Verify accuracy and reliability at least Verify accuracy and reliability at least

twice a yeartwice a year

CLIP – Laboratories performing minimally complex testsCLIP – Laboratories performing minimally complex tests

A laboratory performing minimally complex tests must A laboratory performing minimally complex tests must file a separate certificate for each laboratory locationfile a separate certificate for each laboratory location

Exceptions:Exceptions:• Lab not in a fixed location, i.e. health screening fair Lab not in a fixed location, i.e. health screening fair

or mobile vanor mobile van

• Labs engaged in public health testingLabs engaged in public health testing

• Labs under a single hospital/commander may file a Labs under a single hospital/commander may file a single (one certificate for all hospital’s waived testing single (one certificate for all hospital’s waived testing sites) or multiple applications sites) or multiple applications

CLIP – Laboratories performing minimally complex testsCLIP – Laboratories performing minimally complex tests

CLIP – Laboratories performing Provider Performed Microscopy CLIP – Laboratories performing Provider Performed Microscopy (PPM)(PPM)

Definition of PPMDefinition of PPM

• A test personally performed by one of the following A test personally performed by one of the following practitioners:practitioners:1. Physician1. Physician2. Midlevel practitioner (nurse practitioner, midwife, physician 2. Midlevel practitioner (nurse practitioner, midwife, physician assistant)assistant)3. Dentist3. Dentist

• The procedure must be classified as moderately complexThe procedure must be classified as moderately complex

• The primary instrument is the microscopeThe primary instrument is the microscope

• The specimen is labileThe specimen is labile

• Control materials are not available to monitor the entire Control materials are not available to monitor the entire testing processtesting process

• Limited specimen handling or processing is requiredLimited specimen handling or processing is required

• Laboratory qualifies for a certificate of PPM Laboratory qualifies for a certificate of PPM (not more than five sites per certificate) if it (not more than five sites per certificate) if it restricts its tests to Provider Performed restricts its tests to Provider Performed Microscopy procedures and Waived tests.Microscopy procedures and Waived tests.

• PPM is a subcategory of Moderate PPM is a subcategory of Moderate complexity complexity

• Examples of tests: All direct mount Examples of tests: All direct mount preparations, KOH preparations, Fern tests, preparations, KOH preparations, Fern tests, Urine sediment examinationsUrine sediment examinations

CLIP – Laboratories performing Provider Performed Microscopy CLIP – Laboratories performing Provider Performed Microscopy (PPM)(PPM)

CLIP – laboratories performing tests of moderate and high CLIP – laboratories performing tests of moderate and high complexitycomplexity

Definition of high/moderate (Non-Definition of high/moderate (Non-waived) complexity testing:waived) complexity testing:

• A test system, assay, and A test system, assay, and examination categorized as examination categorized as high/moderate complexity by the high/moderate complexity by the Federal Register (define by CMS and Federal Register (define by CMS and published by CDC)published by CDC)

Requirements for a certificate of high/moderate complexity (at Requirements for a certificate of high/moderate complexity (at a minimum):a minimum):

• Must have a procedure manualMust have a procedure manual

• Must follow manufacturers instructionsMust follow manufacturers instructions

• Must run a controlMust run a control

• Must enroll in proficiency testing (PT)Must enroll in proficiency testing (PT)

• Must identify and resolve problemsMust identify and resolve problems

• Must be accreditedMust be accredited

CLIP – laboratories performing tests of moderate and high CLIP – laboratories performing tests of moderate and high complexitycomplexity

Application for a certificate of Application for a certificate of registrationregistration

• Application must be made on form Application must be made on form prescribed by OASD(HA) designeeprescribed by OASD(HA) designee

• Be signed by commander of the Be signed by commander of the hospital or clinichospital or clinic

• Describe characteristics of laboratory:Describe characteristics of laboratory:– Test procedures and volumeTest procedures and volume– Methodologies for each lab testMethodologies for each lab test– Qualifications of personnelQualifications of personnel

• See Attachment (A) pages 1- 6See Attachment (A) pages 1- 6

• Certificate is valid for two years. Certificate is valid for two years.

• Must obtain certificate Must obtain certificate beforebefore performing performing and reporting resultsand reporting results

• The laboratory must meet all CLIP standardsThe laboratory must meet all CLIP standards

• May undergo unannounced inspections by May undergo unannounced inspections by TSG or their designeeTSG or their designee

Application for a certificate of registrationApplication for a certificate of registration

Application for a certificate of registrationApplication for a certificate of registration

Minimal Complexity and PPMMinimal Complexity and PPM::

• Must submit renewal application every 2 Must submit renewal application every 2 yearsyears

• Must demonstrate compliance with CLIP:Must demonstrate compliance with CLIP:– testing and reporting is performed correctlytesting and reporting is performed correctly– not performing tests not listed on applicationnot performing tests not listed on application– correct specimen procurement and correct specimen procurement and

processingprocessing

Application for certificate of registrationApplication for certificate of registration

High and Moderate ComplexityHigh and Moderate Complexity

• Valid for two yearsValid for two years

• Must provide proof of accreditation:Must provide proof of accreditation:– within 11 months of issuance of within 11 months of issuance of

registrationregistration– If proof of accreditation is not provided, If proof of accreditation is not provided,

suspension, revocation or limitations of suspension, revocation or limitations of laboratory registration testing will occurlaboratory registration testing will occur

CLIP CERTIFICATE CLIP CERTIFICATE REGISTRATIONREGISTRATION• PLEASE SEE ATTACHMENT (A) pages 1-6 PLEASE SEE ATTACHMENT (A) pages 1-6

(DoD Registration Form CLIP) for (DoD Registration Form CLIP) for reference for the next slides reference for the next slides presentation presentation

• PLEASE SEE ATTACHMENT (B) – Key to PLEASE SEE ATTACHMENT (B) – Key to Registration CertificatesRegistration Certificates

• PLEASE SEE ATTACHMENT (C) – PLEASE SEE ATTACHMENT (C) – Instruction for Completing Registration Instruction for Completing Registration FormsForms

CCLM website: www.afip.org/OCLABCCLM website: www.afip.org/OCLAB

Page 1 – Cover pageMust accompany all applications or registration

Contains general information about the laboratory

When submitted, must be signed by director and organization commander

Each site must have its own cover sheet. You cannot combine different complexities under one cover sheet.

Page 2 – Minimal application

Application must have cover page and minimal complexity page

A certificate may have more than one site

Must enter lab information for each site

There is no limit to the number of minimal complexity sites that one director can direct

Application must have cover page and PPM page

A certificate may have more than one site (5 max)

Must enter lab information for each site

Page 3 – PPM application

Used for a certificate with multiple sites

Must enter lab information for each site

Can direct no more than a combination of FIVE high/moderate complexity sites (includes PPM)

Page 4 – Multiple sites (Mod/High complexity)

Application must have cover page, page 5 and 6 (single site) or pages 4, 5, 6 (multiple sites)

This page addresses testing personnel information and educational qualifications

Applications must also be accompanied with a CV for the director

Page 5 – Moderate or High Complexity

Page 6 – Moderate or High Complexity

This page addresses specialties, test volumes, and methods

Notification requirementsNotification requirements Laboratories must notify CLIP within 30 Laboratories must notify CLIP within 30

days of any changes in:days of any changes in:• namename• locationlocation• DirectorDirector• New test – need PT orderNew test – need PT orderNotify accreditation program Notify accreditation program • Changes in “Activity Menu” -new Changes in “Activity Menu” -new

tests, deletion of teststests, deletion of tests• Director changeDirector change

Revocation of certificateRevocation of certificate

A certificate of registration may be A certificate of registration may be revoked or suspended due to failure revoked or suspended due to failure

to:to:

• Meet requirements of CLIPMeet requirements of CLIP

• Meet accreditation requirementsMeet accreditation requirements

• Meet proficiency testing requirementsMeet proficiency testing requirements

• Permit complaint inspectionsPermit complaint inspections

• Correct deficienciesCorrect deficiencies

Certificate of registrationCertificate of registration

Questions?Questions?

Proficiency Testing (PT)Proficiency Testing (PT)

All high/moderate complexity laboratories must All high/moderate complexity laboratories must enroll in a proficiency testing programenroll in a proficiency testing program

Must enroll in an approved PT program for each Must enroll in an approved PT program for each specialty, subspecialties, analyte or testspecialty, subspecialties, analyte or test

Used for the primary method for patient testingUsed for the primary method for patient testing

Definition:Definition:

A method of establishing and A method of establishing and maintaining the accuracy and maintaining the accuracy and reliability of its testing procedures.reliability of its testing procedures.

Proficiency Testing (PT)Proficiency Testing (PT)

Proficiency Testing (PT)Proficiency Testing (PT)

• Required for all analytes listed in your Required for all analytes listed in your Activity MenuActivity Menu

• PT samples are sent from the approved PT PT samples are sent from the approved PT provider (CAP) in each of three shipments provider (CAP) in each of three shipments (events) per year(events) per year

• Samples must be treated the same as Samples must be treated the same as regular patient samples (no special handling)regular patient samples (no special handling)

• General acceptable score is 80% or better for General acceptable score is 80% or better for each event except Blood Bank which is 100%each event except Blood Bank which is 100%

Proficiency Testing (PT) Do’sProficiency Testing (PT) Do’s

• EnrollmentEnrollment

• ParticipationParticipation

• Evaluation of resultsEvaluation of results

• Investigation of failuresInvestigation of failures

• Corrective actionsCorrective actions

• Maintenance of recordMaintenance of record

Proficiency Testing (PT) Don’tsProficiency Testing (PT) Don’ts

• Test sample differently than patient Test sample differently than patient specimensspecimens

• Have same Tech (or Supervisor) Have same Tech (or Supervisor) always do the testingalways do the testing

• Refer samples to another lab/Accept Refer samples to another lab/Accept referred PT samples: Result in referred PT samples: Result in accreditation revocation, suspension accreditation revocation, suspension and/or monetary fineand/or monetary fine

• Discuss results before reportingDiscuss results before reporting

• There is no distinction between regulated and There is no distinction between regulated and non-regulated analytesnon-regulated analytes

• Most specialties must maintain at least a grade Most specialties must maintain at least a grade of 80% (micro, immuno, chem, hem, etc)of 80% (micro, immuno, chem, hem, etc)

• Pathologists/cytotechnologists must be Pathologists/cytotechnologists must be individually tested every year (PAP PT)individually tested every year (PAP PT)

• Immunohematology (Blood Bank) must Immunohematology (Blood Bank) must maintain a grade of 100%maintain a grade of 100%

Proficiency Testing (PT) – successful Proficiency Testing (PT) – successful participationparticipation

PT Failures:PT Failures:Directed Plan of Corrective Directed Plan of Corrective

ActionAction• CLIP Action 1 (CMS Scorecard 2)CLIP Action 1 (CMS Scorecard 2)

– First First unsatisfactoryunsatisfactory PT performance PT performance

• CLIP Action 2 (CMS Scorecard 3)CLIP Action 2 (CMS Scorecard 3)– UnsuccessfulUnsuccessful performance in 2 of 3 testing performance in 2 of 3 testing

eventsevents

• CLIP Action 3CLIP Action 3– RepetitiveRepetitive (unsuccessful) PT failures. 3 out 4 (unsuccessful) PT failures. 3 out 4

testing events.testing events.

• See Attachment D – Directed POA for See Attachment D – Directed POA for Failed PTFailed PT

Unsatisfactory PT:Unsatisfactory PT:Directed Plan of Corrective Directed Plan of Corrective

ActionAction• CLIP Action 1 (CMS Scorecard Risk CLIP Action 1 (CMS Scorecard Risk

Code 2)Code 2)

• First unsatisfactory PT performanceFirst unsatisfactory PT performance– Perform investigation and correct Perform investigation and correct

problemproblem– Verify corrective actionVerify corrective action– Document and retain for 2 yearsDocument and retain for 2 years

Unsuccessful PT:Unsuccessful PT:Directed Plan of Corrective Directed Plan of Corrective

ActionAction• CLIP Action 2 (CMS Scorecard at Risk Code 3)CLIP Action 2 (CMS Scorecard at Risk Code 3)

• Unsuccessful performance in 2 of 3 testing Unsuccessful performance in 2 of 3 testing eventsevents– Will automatically generate a memo from CCLM to Will automatically generate a memo from CCLM to

the lab director via the lab MTF COthe lab director via the lab MTF CO– Discontinue testingDiscontinue testing until The ff actions are taken: until The ff actions are taken:

• Perform investigation and correct problemPerform investigation and correct problem

• Verify corrective action by other than internal QCVerify corrective action by other than internal QC

– Director approves resumption of testingDirector approves resumption of testing– Document and retain for 2 yearsDocument and retain for 2 years– Provide CCLM via fax or email attachment with Provide CCLM via fax or email attachment with

documentation 72 hours after resumption of documentation 72 hours after resumption of testing.testing.

Repetitive PT failures:Repetitive PT failures:Directed Plan of Corrective Directed Plan of Corrective

ActionAction• CLIP Action 3 - Repetitive PT Failures (3 out CLIP Action 3 - Repetitive PT Failures (3 out of 4 consecutive surveys)of 4 consecutive surveys)– Will automatically generate a memo from CCLM Will automatically generate a memo from CCLM

to the lab director via the lab MTF Commanding to the lab director via the lab MTF Commanding OfficerOfficer

– Discontinue testing of analyte or testDiscontinue testing of analyte or test– Follow CLIP Action 2 actionsFollow CLIP Action 2 actions– CCLM will advise on actions to take prior to CCLM will advise on actions to take prior to

resumption of testing when all PCA and resumption of testing when all PCA and documentation where received and reviewed if documentation where received and reviewed if there’s no “cease testing” order from CAP. there’s no “cease testing” order from CAP. Otherwise CAP will determine when they can start Otherwise CAP will determine when they can start testing with CCLM concurrence.testing with CCLM concurrence.

Investigating PT Failures and Investigating PT Failures and Corrective Action Corrective Action

• See Attachment D – Directed POA for See Attachment D – Directed POA for Failed PTFailed PT

• See Attachment E – Reading Your PT See Attachment E – Reading Your PT Evaluation ReportEvaluation Report

• See Attachment F – Investigation See Attachment F – Investigation FlowchartFlowchart

• See Attachment G – PT Deviation See Attachment G – PT Deviation Report from CAPReport from CAP

Closing PT FailuresClosing PT Failures• IncludesIncludes

- Explanation of investigation- Explanation of investigation

- Documentation of external validation - Documentation of external validation (reinstatement PT-paid by CCLM)(reinstatement PT-paid by CCLM)

- Impact on patient care- Impact on patient care

- Implementation of new - Implementation of new processes/procedures to prevent processes/procedures to prevent recurrencerecurrence

- Documentation send to CCLM and CAP- Documentation send to CCLM and CAP

Not Closing PT FailuresNot Closing PT Failures• Generates multiple memo from CCLM Generates multiple memo from CCLM

to MTF Commanding Officer via to MTF Commanding Officer via Laboratory Director until PT is resolved.Laboratory Director until PT is resolved.

• May results in sanctions:May results in sanctions:– Suspension or Cessation of testingSuspension or Cessation of testing– Suspension or revocation of accreditationSuspension or revocation of accreditation– Suspension or revocation of CLIP Suspension or revocation of CLIP

certificatecertificate

Proficiency TestingProficiency Testing

Questions?Questions?

Accreditation InspectionsAccreditation Inspections

• Conducted bienniallyConducted biennially

• Most labs use CAP, JCAHO or COLAMost labs use CAP, JCAHO or COLA

• Purpose is to improve the quality of Purpose is to improve the quality of clinical laboratory services through clinical laboratory services through voluntary participation, professional voluntary participation, professional peer review, education, and peer review, education, and compliance with established compliance with established performance standards performance standards

• Most paperwork is handled directly with Most paperwork is handled directly with

CAP ie. applications, medical director CAP ie. applications, medical director changes, etcchanges, etc

• CCLM manages the centralized contract CCLM manages the centralized contract for CAP inspections – means CCLM paysfor CAP inspections – means CCLM pays

• Automatically receive a final copy of all Automatically receive a final copy of all inspection report and automatically inspection report and automatically renew CLIP certificatesrenew CLIP certificates

ACCREDITATION INSPECTIONSACCREDITATION INSPECTIONS

ACCREDITATION INSPECTIONSACCREDITATION INSPECTIONS

• Need to knowNeed to know– Unannounced inspection but CCLM knowUnannounced inspection but CCLM know

•Exceptions:Exceptions:– International (OCONUS)International (OCONUS)– Initial inspectionInitial inspection– Reproductive and Forensic Drug TestingReproductive and Forensic Drug Testing

– CAP will send LAP package 6-9 months CAP will send LAP package 6-9 months prior to anniversary dateprior to anniversary date•Lab will complete application and send back to Lab will complete application and send back to

CAPCAP

•Recommend to add all your facility’s CLIP Recommend to add all your facility’s CLIP number including Waive and PPM ( Navy – number including Waive and PPM ( Navy – required)required)

ACCREDITATION INSPECTIONSACCREDITATION INSPECTIONS

• Need to knowNeed to know– Out of cycle (non-routine) inspection may be Out of cycle (non-routine) inspection may be

funded by CCLM - (AF – no way)funded by CCLM - (AF – no way)– Initial (New Lab) LAP application – must Initial (New Lab) LAP application – must

notify CCLM to add lab to the CAP contract. notify CCLM to add lab to the CAP contract. You don’t , you pay.You don’t , you pay.

– May request additional blackout date due to May request additional blackout date due to unexpected operational commitmentunexpected operational commitment•Must be coordinated through CCLMMust be coordinated through CCLM

Questions?Questions?

Thank you for coming and Thank you for coming and listeninglistening

NOW, lets go and discover N.O.NOW, lets go and discover N.O.

Accreditation InspectionsAccreditation Inspections

ReferencesReferences

• Public Law 100-578, CLIA-88Public Law 100-578, CLIA-88

• CMS/DOD MOA dated 16 Jan 2003CMS/DOD MOA dated 16 Jan 2003

• DODI 6440.2, 20 April 1994, DODI 6440.2, 20 April 1994, establishes CLIPestablishes CLIP

• AFIP Pamphlet 40-24 dated 1 AFIP Pamphlet 40-24 dated 1 November 2002 (DOD CLIP provides November 2002 (DOD CLIP provides current guidance)current guidance)

Useful websitesUseful websites

• http://www.afip.org/OCLAB/index.htmlhttp://www.afip.org/OCLAB/index.html

• www.phppo.cdc.gov/clia/testcat.aspxwww.phppo.cdc.gov/clia/testcat.aspx

• www.cms.hhs.gov/clia/www.cms.hhs.gov/clia/

• www.cap.org/apps/cap.portalwww.cap.org/apps/cap.portal

• www.jcaho.orgwww.jcaho.org

DoD-CLIP, CCLMDoD-CLIP, CCLMPoints of ContactPoints of Contact

Army Navy Air Force

COL Harms (202) 782-2514 DSN 662-2514 harmsd@afip.osd.mil

CDR Ciolorito (202) 782-2267 DSN 662-2267 cioloritol@afip.osd.mil

Maj Catalasan (202) 782-2582 DSN 662-2582 catalasani@afip.osd.mil

SSG Wise/SGM Wojtaszczyk (202) 782-2468/1642 DSN 662-2468/1642 wisec@afip.osd.mil wojtaszczykr@afip.osd.mil

HMC Rapisura (202) 782-2467 DSN 662-2467 rapisurag@afip.osd.mil

MSGT Brown (202) 782-2585 DSN 662-2585 brownga@afip.osd.mil

General CCLM Office General CCLM Office InformationInformation

• ARMED FORCES INSTITUTE OF PATHOLOGYARMED FORCES INSTITUTE OF PATHOLOGY Office of Clinical Laboratory AffairsOffice of Clinical Laboratory Affairs

Center for Clinical Laboratory MedicineCenter for Clinical Laboratory MedicineBldg 54, Room G134Bldg 54, Room G134

6825 166825 16THTH Street NW, Washington, DC Street NW, Washington, DC 2030620306

• Homepage: Homepage: http://www.afip.org/OCLAB/index.htmlhttp://www.afip.org/OCLAB/index.html

• FAX: (202) 782-6022 DSN: 662-6022FAX: (202) 782-6022 DSN: 662-6022

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