DoD Clinical Laboratory Improvement Program (DoD-CLIP

1
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)

2
Topics for Discussion

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

3
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)

4
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.

5
CLIA'88

• Revised and superseded CLIA'67
• The Centers for Medicare /Medicaid Studies (CMS)
  provides oversight for the program
• Incorporated four separate sets of rules for
  implementation
• DOD allowed to develop separate plan with certain
  restrictions

6
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
• DOD Clinical Laboratory Improvement Advisory
  Committee met in Washington DC from 20-23 July
  1992 and developed final draft of CLIP.
• Coordinated through Service Surgeon Generals on
  29 September 92

7
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 tri-service personnel and
  provides oversight for the program.

8
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

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Complexity Definitions

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

10
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)

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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

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

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Overview of DoD CLIP Requirements

• Type of Laboratory
• Minimal Complexity
• Moderate Complexity
• PPM
• High Complexity

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

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Accrediting Organizations (Deemed Status)

• Joint Commission on Accreditation of Healthcare
  Organizations (JCAHO)
• College of American Pathologists (CAP)
• Army, Air Force and Navy has a centralize
  contract for PT and Accreditation
• Commission on Office Laboratory Accreditation
  (COLA)
• Certain States also have deemed status
• Etc.

15
Registration Process

• Registration http//www.afip.org/OCLAB/index.htm
  l
• 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.

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Types of Certificates

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

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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

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QUESTIONS

• THANK YOU FOR LISTENING AND YOUR TIME

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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

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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

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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

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CLIP - Complexities

• Tests are categorized as one of the following
• Minimal complexity (Waived)
• Non-Waived
• Moderate complexity, including subcategory
  provider performed microscopy (PPM)
• High complexity

23
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

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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

25
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

26
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

27
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

28
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

29
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)

30
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

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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

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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

33
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

34
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

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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

36
CCLM website www.afip.org/OCLAB
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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.
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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
39
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
40
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)
41
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 Applic
ations must also be accompanied with a CV for the
director
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Page 6 Moderate or High Complexity
This page addresses specialties, test volumes,
and methods
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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

44
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

45
Certificate of registration

• Questions?

46
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

47
Proficiency Testing (PT)

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

48
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

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Proficiency Testing (PT) Dos

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

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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

51
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

52
PT FailuresDirected Plan of Corrective Action

• CLIP Action 1 (CMS Scorecard 2)
• First unsatisfactory PT performance
• CLIP Action 2 (CMS Scorecard 3)
• Unsuccessful performance in 2 of 3 testing events
• CLIP Action 3
• Repetitive (unsuccessful) PT failures. 3 out 4
  testing events.
• See Attachment D Directed POA for Failed PT

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Unsatisfactory PTDirected 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

54
Unsuccessful PTDirected 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.

55
Repetitive PT failuresDirected 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.

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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

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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

58
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

59
Proficiency Testing

• Questions?

60
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

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ACCREDITATION INSPECTIONS

• Most paperwork is handled directly with CAP ie.
  applications, medical director changes, etc
• CCLM manages the centralized contract for CAP
  inspections means CCLM pays
• Automatically receive a final copy of all
  inspection report and automatically renew CLIP
  certificates

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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)

63
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

64
Accreditation Inspections

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

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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)

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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

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DoD-CLIP, CCLMPoints of Contact
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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 [phone] DSN 662-6022

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ANY QUESTIONS OR COMMENTS

• Thank you