DoD Clinical Laboratory Improvement Program (DoD-CLIP)

Presented By: HMC Gerry S. Rapisura, USN, MT(ASCP) Navy Program Manager, DoD-CLIP MSgt Gary Brown, USAF Air Force Program Manager, DoD-CLIP Center for Clinical Laboratory Medicine (CCLM)

Topics for Discussion

Overview of CCLM CLIP Program and certificates CAP surveys and inspections CAP PT failures Useful websites Contact Information

History
Clinical Laboratory Improvement Act of 1967
Applied only to laboratories involved in interstate commerce. Had little impact on the laboratory community

Adverse publicity regarding PAP smears and physician

office laboratory testing (POL)

Response of Congress (amends PL 100-578)

The Clinical Laboratory Improvement Amendments of 1988 Published March 1992

Included Federal Facilities (DOD facilities not exempt)

CLIA'88
Purpose: To improve the quality of
any testing conducted for medical purposes.

Broadly applicable: Congress required

every testing site examining materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease to be regulated.

CLIA'88
Revised and superseded CLIA'67

The Centers for Medicare &/Medicaid

Studies (CMS) provides oversight for the program implementation

Incorporated four separate sets of rules for

DOD allowed to develop separate plan with

certain restrictions

History Clinical Laboratory Improvement Program (DoD-CLIP)

Meeting of representatives from the three
services to draft original plan from CLIA 88 Code of Federal Regulations in April 1992 Advisory Committee met in Washington DC from 20-23 July 1992 and developed final draft of CLIP. Generals on 29 September 92

DOD Clinical Laboratory Improvement

Coordinated through Service Surgeon

DOD Program
To be called Clinical Laboratory
Improvement Program (DoD-CLIP).
AFIP PAM 40-24 DOD-CLIP Program

Very much like CLIA with certain

exceptions to meet military operational requirements.

Office of Clinical Laboratory Affairs

(OCLA), Center for Clinical Laboratory Medicine (CCLM) in AFIP staffed by triservice personnel and provides oversight for the program.

Registration Required for all DoD Clinical Testing Sites

Based on complexity of testing
Minimally Complex (Waived) Moderate Provider-Performed Microscopy (PPM) High

Currently have 1251 certificates issued

with 2471 testing sites

Complexity Definitions
Minimal Complexity (Waived) tests are
those laboratory examinations and procedures that employ accurate but simple methodologies (mostly FDA approved home tests) defined as moderate complexity by the Centers for Medicare & Medicaid Studies (CMS) and published by the Center for Disease Control (CDC)

Moderate Complexity tests are those

Complexity Definitions
High Complexity tests are those defined
as high complexity by CMS and published by CDC (also includes non-FDA approved procedures) Any deviation from the manufacturers instructions automatically classifies a test as high complexity CDC Web site lists all tests by complexity
(www.fda.gov/cdrh/CLIA/index.html)

Program Requirements
Personnel Standards - Defined for each category of
testing (director, clinical consultant, technical consultant, general supervisor, and testing personnel)

Quality Control (QC) - monitors the actual analytical

testing process

Quality Assurance (QA) - all phases of the testing

process are monitored

Procedure Manuals - meeting National Committee for

Clinical Laboratory Science (NCCLS) GP2-A3 format

Program Requirements
Patient Test Management Process (Pre,
Analytical, Post)

Proficiency Testing - Mandatory for PPM,

moderate and high complexity sites (even for waived sites, test accuracy must be verified at least twice annually) privileges are suspended or revoked for facilities out of compliance

Inspections and Sanctions - testing

Overview of DoD CLIP Requirements

Type of Laboratory Minimal Complexity

Requirements
Registration and good laboratory practice QC, QA, PT, Limited Personnel, Accreditation QC, QA, PT, Stringent Personnel, Accreditation

Moderate Complexity
PPM

High Complexity

Accrediting Organizations (Deemed Status)

Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)

College of American Pathologists (CAP)

(COLA)

Commission on Office Laboratory Accreditation

Army, Air Force and Navy has a centralize contract for PT and Accreditation

Certain States also have deemed status Etc.

Registration Process
Registration:
http://www.afip.org/OCLAB/index.html
Initial snapshot of facility Type of laboratory (complexity) Director, by name List of personnel and education Test volume and methodology

Certificates are valid for two years Discuss in details on later presentation.

Types of Certificates
Registration Certificate Certificate for Minimal Complexity Testing Certificate for Provider-Performed
Microscopy Certificate of Compliance Certificates of Accreditation

DoD-CLIP LAP/PT Funding

OCLA, CCLM centrally contracts for:
Accreditation inspection (LAP) costs for CAP accredited laboratories Proficiency testing (surveys) through CAP Means CCLM will pay your LAP and PT

Non-CAP LAP and PT are self pay. Nice to know: Not all CAP PT are funded

by CCLM. Check with your corresponding service Program Manager for exemption

QUESTIONS

THANK YOU FOR LISTENING AND YOUR TIME

DoD-CLIP, CCLM
Established with an MOA between the
DoD and DHHS

Purpose is to establish standards and

policy for implementation of quality clinical laboratory testing within the DoD

DoD - Clinical laboratory Improvement Program (CLIP) What is it?

Military equivalent of CLIA 88 (Clinical

Laboratory Improvement Amendments of 1988) Sets forth the minimum conditions that all laboratories must meet to be certified to perform testing under the DoD CLIP Laboratories under DoD jurisdiction are subject to the rules of this program

DoD-CLIP - Exceptions
During declared or undeclared wars, or period of

mobilization Testing for forensic purposes only Research laboratories that test human specimens, but do not report patient results for diagnosis Some laboratories performing drug testing Medical laboratories assigned to field medical units that perform limited human testing Navy Ships Laboratories

CLIP - Complexities
Tests are categorized as one of the following: 1. Minimal complexity (Waived) 2. Non-Waived
Moderate complexity, including subcategory provider performed microscopy (PPM) High complexity

CLIP Laboratories performing minimally complex tests

Definition of minimally complex:

A test cleared by the FDA for home use

employs methodologies that are simple and

accurate

pose minimal risk of harm to the patient if

performed incorrectly

CLIP Laboratories performing minimally complex tests

Laboratory qualifies for a certificate of

minimal complexity if it restricts its tests to minimal complexity Sites with minimal complexity certificates are normally your outlying point of care testing sites Examples: Urine HCG, fecal occult blood, urine dipstick, glucose, cholesterol

CLIP Laboratories performing minimally complex tests

Laboratories eligible for a certificate of

minimal complexity must:
Follow manufacturers instructions Analyze and document controls Ensure training and competency is documented Verify accuracy and reliability at least twice a year

CLIP Laboratories performing minimally complex tests

A laboratory performing minimally complex tests must file a separate certificate for each laboratory location Exceptions: Lab not in a fixed location, i.e. health screening fair or mobile van

Labs engaged in public health testing

Labs under a single hospital/commander may file a

single (one certificate for all hospitals waived testing sites) or multiple applications

CLIP Laboratories performing Provider Performed Microscopy (PPM) Definition of PPM

A test personally performed by one of the following practitioners:

1. Physician 2. Midlevel practitioner (nurse practitioner, midwife, physician assistant) 3. Dentist

The procedure must be classified as moderately complex

The primary instrument is the microscope

The specimen is labile

Control materials are not available to monitor the entire testing
process

Limited specimen handling or processing is required

CLIP Laboratories performing Provider Performed Microscopy (PPM)

Laboratory qualifies for a certificate of PPM

(not more than five sites per certificate) if it restricts its tests to Provider Performed Microscopy procedures and Waived tests.

PPM is a subcategory of Moderate complexity Examples of tests: All direct mount preparations,
KOH preparations, Fern tests, Urine sediment examinations

CLIP laboratories performing tests of moderate and high complexity

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

A test system, assay, and examination

categorized as high/moderate complexity by the Federal Register (define by CMS and published by CDC)

CLIP laboratories performing tests of moderate and high complexity Requirements for a certificate of high/moderate complexity (at a minimum):

Must have a procedure manual

Must follow manufacturers instructions Must run a control Must enroll in proficiency testing (PT) Must identify and resolve problems

Must be accredited

Application for a certificate of registration

Application must be made on form

prescribed by OASD(HA) designee Be signed by commander of the hospital or clinic Describe characteristics of laboratory:
Test procedures and volume Methodologies for each lab test Qualifications of personnel

See Attachment (A) pages 1- 6

Application for a certificate of registration

Certificate is valid for two years. Must obtain certificate before performing and
reporting results

The laboratory must meet all CLIP standards

May undergo unannounced inspections by TSG

or their designee

Application for a certificate of registration

Minimal Complexity and PPM:

Must submit renewal application every 2
years Must demonstrate compliance with CLIP:
testing and reporting is performed correctly not performing tests not listed on application correct specimen procurement and processing

Application for certificate of registration

High and Moderate Complexity Valid for two years Must provide proof of accreditation:
within 11 months of issuance of registration If proof of accreditation is not provided, suspension, revocation or limitations of laboratory registration testing will occur

CLIP CERTIFICATE REGISTRATION

PLEASE SEE ATTACHMENT (A) pages 1-6
(DoD Registration Form CLIP) for reference for the next slides presentation

PLEASE SEE ATTACHMENT (B) Key to

Registration Certificates

PLEASE SEE ATTACHMENT (C)

Instruction for Completing Registration Forms

CCLM website: www.afip.org/OCLAB

Page 1 Cover page

Must 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

Page 3 PPM application

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 4 Multiple sites (Mod/High complexity)

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 5 Moderate or 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 6 Moderate or High Complexity

This page addresses specialties, test volumes, and methods

Notification requirements

Laboratories must notify CLIP within 30 days of any changes in: name location Director New test need PT order Notify accreditation program Changes in Activity Menu -new tests, deletion of tests Director change

Revocation of certificate

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

Meet requirements of CLIP Meet accreditation requirements Meet proficiency testing requirements Permit complaint inspections Correct deficiencies

Certificate of registration

Questions?

Proficiency Testing (PT)

All high/moderate complexity laboratories must enroll in a proficiency testing program Must enroll in an approved PT program for each specialty, subspecialties, analyte or test
Used for the primary method for patient testing

Proficiency Testing (PT)

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

Proficiency Testing (PT)

Required for all analytes listed in your Activity

Menu PT samples are sent from the approved PT provider (CAP) in each of three shipments (events) per year Samples must be treated the same as regular patient samples (no special handling) General acceptable score is 80% or better for each event except Blood Bank which is 100%

Proficiency Testing (PT) Dos

Enrollment Participation Evaluation of results Investigation of failures Corrective actions Maintenance of record

Proficiency Testing (PT) Donts

Test sample differently than patient
specimens Have same Tech (or Supervisor) always do the testing Refer samples to another lab/Accept referred PT samples: Result in accreditation revocation, suspension and/or monetary fine Discuss results before reporting

Proficiency Testing (PT) successful participation

There is no distinction between regulated and non-regulated analytes Most specialties must maintain at least a grade of 80% (micro, immuno, chem, hem, etc) Pathologists/cytotechnologists must be individually tested every year (PAP PT)

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

 CLIP Action 1 (CMS Scorecard 2)

CLIP Action 2 (CMS Scorecard 3) CLIP Action 3

Directed Plan of Corrective Action

PT Failures:

First unsatisfactory PT performance Unsuccessful performance in 2 of 3 testing events Repetitive (unsuccessful) PT failures. 3 out 4 testing events.

See Attachment D Directed POA for Failed

PT

Directed Plan of Corrective Action

CLIP Action 1 (CMS Scorecard Risk Code
2) First unsatisfactory PT performance
Perform investigation and correct problem Verify corrective action Document and retain for 2 years

Unsatisfactory PT:

Directed Plan of Corrective Action

CLIP Action 2 (CMS Scorecard at Risk Code 3) Unsuccessful performance in 2 of 3 testing events
Will automatically generate a memo from CCLM to the lab director via the lab MTF CO Discontinue testing until The ff actions are taken: Perform investigation and correct problem Verify corrective action by other than internal QC Director approves resumption of testing Document and retain for 2 years Provide CCLM via fax or email attachment with documentation 72 hours after resumption of testing.

Unsuccessful PT:

Directed Plan of Corrective Action

CLIP Action 3 - Repetitive PT Failures (3 out of 4
consecutive surveys)
Will automatically generate a memo from CCLM to the lab director via the lab MTF Commanding Officer Discontinue testing of analyte or test Follow CLIP Action 2 actions CCLM will advise on actions to take prior to resumption of testing when all PCA and documentation where received and reviewed if theres no cease testing order from CAP. Otherwise CAP will determine when they can start testing with CCLM concurrence.

Repetitive PT failures:

Investigating PT Failures and Corrective Action

See Attachment D Directed POA for
Failed PT See Attachment E Reading Your PT Evaluation Report See Attachment F Investigation Flowchart See Attachment G PT Deviation Report from CAP

Closing PT Failures
Includes
- Explanation of investigation - Documentation of external validation (reinstatement PT-paid by CCLM) - Impact on patient care - Implementation of new processes/procedures to prevent recurrence - Documentation send to CCLM and CAP

Not Closing PT Failures

Generates multiple memo from CCLM to
MTF Commanding Officer via Laboratory Director until PT is resolved.

May results in sanctions:

Suspension or Cessation of testing Suspension or revocation of accreditation Suspension or revocation of CLIP certificate

Proficiency Testing

Questions?

Accreditation Inspections

Conducted biennially Most labs use CAP, JCAHO or COLA

Purpose is to improve the quality of

clinical laboratory services through voluntary participation, professional peer review, education, and compliance with established performance standards

ACCREDITATION INSPECTIONS

Most paperwork is handled directly with

CAP ie. applications, medical director changes, etc

CCLM manages the centralized contract Automatically receive a final copy of all

for CAP inspections means CCLM pays inspection report and automatically renew CLIP certificates

ACCREDITATION INSPECTIONS

Need to know
Unannounced inspection but CCLM know Exceptions:
International (OCONUS) Initial inspection Reproductive and Forensic Drug Testing

CAP will send LAP package 6-9 months prior to anniversary date Lab will complete application and send back to CAP Recommend to add all your facilitys CLIP number
including Waive and PPM ( Navy required)

ACCREDITATION INSPECTIONS

Need to know
Out of cycle (non-routine) inspection may be funded by CCLM - (AF no way) Initial (New Lab) LAP application must notify CCLM to add lab to the CAP contract. You dont , you pay. May request additional blackout date due to unexpected operational commitment Must be coordinated through CCLM

Accreditation Inspections
Questions? Thank you for coming and listening NOW, lets go and discover N.O.

References
Public Law 100-578, CLIA-88 CMS/DOD MOA dated 16 Jan 2003 DODI 6440.2, 20 April 1994, establishes

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

Useful websites
http://www.afip.org/OCLAB/index.html
www.phppo.cdc.gov/clia/testcat.aspx

www.cms.hhs.gov/clia/
www.cap.org/apps/cap.portal www.jcaho.org

DoD-CLIP, CCLM Points of Contact

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

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

Air Force
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 Information

ARMED FORCES INSTITUTE OF PATHOLOGY
Office of Clinical Laboratory Affairs Center for Clinical Laboratory Medicine Bldg 54, Room G134 6825 16TH Street NW, Washington, DC 20306

Homepage: http://www.afip.org/OCLAB/index.html FAX: (202) 782-6022 DSN: 662-6022

ANY QUESTIONS OR COMMENTS

Thank you