Center for
Clinical Laboratory Medicine
DoD Clinical Laboratory Improvement
Program
Armed Forces Institute of Pathology Pamphlet (AFIP) 40-24
Presenter
Cathy Leppiaho, COL, MS, USA
Assoc Director, Center for Clinical Laboratory Medicine
(202) 782-2514 DSN 662
FAX: 6022
cathy.leppiaho@afip.osd.mil or Cathy.Leppiaho@us.army.mil
CCLM web site: http://www.afip.org/consultation/CCLM/index.html
Center for
Clinical Laboratory Medicine
Topics for Discussion
•
•
•
•
•
•
•
•
•
History of CLIA, CLIP and CCLM
Test Categorization
CLIP Certificate Complexity Levels and Types
CLIP Program Requirements
Proficiency Testing
Quality Control Review (if time allows)
References
Useful Websites
Contact Information
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Center for
Clinical Laboratory Medicine
History
• Clinical Laboratory Improvement Act of 1967
– Regulated any laboratory engaged in interstate commerce
– Had little impact on the laboratory community as a whole
• Beginning in1987
– Adverse publicity regarding PAP smear “mills” and concerns about
physician office laboratory testing (POL)
– Concern regarding the number of laboratories that were not subject to
either Federal or State regulations
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Center for
Clinical Laboratory Medicine
History (cont)
• Response of Congress in October 1988
– Enacted PL 100-578 - the “Clinical Laboratory Improvement
Amendments of 1988” (CLIA ‘88)
• Revised Section 353 of the Public Health Service Act
– Expanded HHS authority from regulation of labs that only accepted and tested specimens in
interstate commerce to the regulation of any lab that tested specimens for the “diagnosis,
prevention, or treatment of any disease or impairment of , or the assessment of the health of
human beings.”
• February 28, 1992 – CLIA ‘88 final rule (42 CFR Part 493) published
in the Federal Register
– implementation date of September 1, 1992
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Center for
Clinical Laboratory Medicine
History (cont)
• 493.3(c) Federal Laboratories
– Laboratories under the jurisdiction of an agency of the Federal
Government are subject to the rules of this part, except that the
Secretary may modify the application of such requirements as
appropriate
– Allowed DoD to modify the application of the CLIA rule to accommodate
the unique mission requirements within the DoD that are not found
within the civilian sector
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Center for
Clinical Laboratory Medicine
History of the
Clinical Laboratory Improvement Program (DoD CLIP)
•
•
•
•
•
•
Meeting of representatives from the three Services to draft original plan
from CLIA ‘88 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 1992
DODI 6440.2 –Clinical Laboratory Improvement Program 20 April 1994
42 CFR starting at part 430 was revised – October 2006
September 2007 New AFIP Pam 40-25
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Center for
Clinical Laboratory Medicine
CLIP - Basis of Requirement
• Clinical Laboratory Improvement Amendments of 1988
(CLIA ’88; 42 CFR 493)
– Oversight provided by the Centers for Medicare and Medicaid
Services (CMS), Department of Health and Human Services
– Federal law that sets forth the conditions that all laboratories
must meet to be certified to perform testing on human specimens
• Laboratory – a facility that examines materials derived from the
human body for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease or impairment of,
or the assessment of the health of, human beings
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Center for
Clinical Laboratory Medicine
DoD Compliance with CLIA ‘88
• DoDI 6440.2 - Clinical Laboratory Improvement
Program (CLIP)
– OASD(HA) has responsibility for program oversight
and policy review on the implementation of CLIA
comparable regulations
– Established the DoD CLIP office at the Armed Forces
Institute of Pathology (AFIP)
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Center for
Clinical Laboratory Medicine
DoD Compliance with CLIA ’88 (cont)
– Per DoDI:
•
CLIA requirements modified only as may be required to meet
unique aspects of DoD missions, training, and preparations
during peace, contingency, and war time operations which
preclude compliance with CLIA
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Center for
Clinical Laboratory Medicine
DoD Compliance with CLIA ’88 (cont)
• CLIP office responsibilities (per DoDI 6440.2)
– Serves as the DoD CLIA program manager
– Develops and issues, with the approval of OASD(HA), the triservice CLIP regulations (AFIP Pam 40-24)
– Identifies, registers, and certifies all appropriate clinical
laboratory testing sites within the DoD
– Provides information on clinical laboratory accreditation and
proficiency testing performance or deficiencies to the appropriate
Service Surgeon General for resolution
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Center for
Clinical Laboratory Medicine
DoD Compliance with CLIA ’88 (cont)
• Implied Responsibilities of Managers/Supervisors Providing
Oversight of Labs
– Identify and register all clinical laboratories and laboratory testing sites
– Renew CLIP registration of laboratories every 2 years
– Ensure the complexity of testing performed is within the scope of the
CLIP certificate held by the lab
– Ensure the lab is inspected or inspected/accredited (with some minor
exceptions)
– Ensure enrollment in a PT program for each of the specialties and
subspecialties in which testing is performed
– Make required notifications within allowed time frame
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Center for
Clinical Laboratory Medicine
AFIP Pam 40-24
• The CLIA ‘88 rules, as modified per consultation with CMS, are
specified in AFIP Pam 40-24
– Current MOA between DoD and CMS runs for a 6-year period beginning
14 January 2009
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Center for
Clinical Laboratory Medicine
AFIP Pam 40-24 (cont)
• Other modifications allowed:
– During declared or undeclared wars, or when under a period of mobilization,
OASD(HA), the Service’s Surgeons General (TSG), or subordinate medical
commanders may temporarily modify these rules as required.
– OASD(HA) or TSG may modify these rules as required for laboratories which are
components of deployable operational forces.
– OASD(HA) or TSG may modify these rules as required for laboratories which are
located in overseas locations.
• REMINDER: Per DODI 6440.2, CLIA ‘88 rules may be modified
ONLY when circumstances PRECLUDE compliance with those
rules
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Center for
Clinical Laboratory Medicine
CLIP Excepted Functions (para 2-1b of Pamphlet)
• Site only performs testing for forensic purposes
• Research labs that do not report patient specific results
• Drug testing labs (regulated by DoDI 1010.16; testing
other than the regulated drug testing is subject to the
Pamphlet’s requirements)
• Deployable medical units or laboratories that perform
limited human testing in a field environment for military
training purposes
– DEPLOYED MEDICAL UNITS OR LABORATORIES
PERFORMING THEIR MISSION ARE SUBJECT TO CLIP!!!
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Center for
Clinical Laboratory Medicine
Test Categorization
• Four categories of test complexity as determined
by the Food and Drug Administration (FDA):
– Minimal Complexity (commonly referred to as waived
testing)
– Provider Performed Microscopy (a subcategory of
moderate complexity testing)
– Moderate Complexity
– High Complexity
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Center for
Clinical Laboratory Medicine
Test Categorization (cont)
• Minimal Complexity (Waived)
– Test systems are simple laboratory examinations and procedures
which:
• Are cleared by the FDA for home use;
• Employ methodologies that are so simple and accurate as to render the
likelihood of erroneous results negligible; or
• Pose no reasonable risk of harm to the patient if the test is performed
inaccurately
– Examples: dipstick or tablet reagent urinalysis (non-automated); fecal
occult blood; ovulation tests by visual color comparison; urine
pregnancy tests by visual color comparison tests; non-automated ESR;
hemoglobin by copper sulfate method; blood glucose by glucose
monitoring devices cleared by the FDA specifically for home use; spun
hematocrit; etc.
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Center for
Clinical Laboratory Medicine
Test Categorization (cont)
• Provider Performed Microscopy (PPM)
– Are a subcategory of moderate complexity tests
• Primary instrument for performing the test is the microscope, limited to
bright-field or phase-contrast microscopy
• Specimen is labile or a delay in performing the test could compromise the
accuracy of the test result
• Control materials are not available to monitor the entire testing process
• Limited specimen handling or processing is required
• Must be personally performed by a physician, a midlevel practitioner
(physician assistant, nurse practitioner, nurse midwife), or a dentist
–
All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites,
and human cellular elements; all potassium hydroxide (KOH) preparations; pinworm
examinations; fern tests; post-coital direct, qualitative examinations of vaginal or cervical
mucous; urine sediment examinations; nasal smears for granulocytes; fecal leukocyte
examinations; qualitative semen analysis (limited to the presence or absence of sperm and
detection of motility)
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Center for
Clinical Laboratory Medicine
Test Categorization (cont)
• Moderate and High Complexity Tests
– All tests that do not meet the criteria for minimal (waived)
complexity tests
– PPM tests revert back to their moderate complexity
categorization when performed by personnel other than a
physician, midlevel practitioner, or dentist
– A higher level of specimen manipulation is required prior to
analysis and/or interpretation is required to determine the test
result
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Center for
Clinical Laboratory Medicine
Test Categorization (cont)
• High Complexity is the default categorization
– A test system, assay, or examination that has not
been categorized is considered to be high complexity
until it is categorized
• if modify a test, i.e., deviate from the manufacturer’s
specifications/instructions for use, the test becomes a high
complexity test
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Center for
Clinical Laboratory Medicine
Test Categorization (cont)
– Performed by the FDA
– Tests scored on 7 criteria required to perform the test to
determine complexity categorization (42 CFR 493.17)
• Knowledge; training & experience; reagents and materials
preparation; characteristics of operational steps; calibration, quality
control, and proficiency testing materials; test system
troubleshooting and equipment maintenance; and interpretation and
judgment
– Database and other CLIA-related information maintained at
http://www.fda.gov/cdrh/clia/index.html
• Direct link to complexity database is:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm
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Clinical Laboratory Medicine
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Clinical Laboratory Medicine
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Clinical Laboratory Medicine
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Clinical Laboratory Medicine
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Clinical Laboratory Medicine
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Clinical Laboratory Medicine
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Clinical Laboratory Medicine
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Center for
Clinical Laboratory Medicine
CLIP PROGRAM REQUIREMENTS
All laboratories must be registered with the CLIP office
BEFORE laboratory testing is initiated
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Center for
Clinical Laboratory Medicine
Chapter 16 - Deployable Medical Units
– If performing health care testing on a routine basis while in garrison
during peace time are required to meet the requirements of CLIP,
except for PT, and units must obtain CLIP registration
– Units that do not perform lab testing on a routine basis when in garrison
are subject to minimum CLIP requirements (i.e., 16-3a)
– Deployed units will adhere to minimum CLIP requirements (i.e., 163a(1) – (3)) unless they are temporarily modified in writing by
OASD(HA), the Service’s Surgeons General, or subordinate medical
commanders.
– Naval shipboard laboratories (including those on U.S. Cost Guard
assets when deployed as a component of Naval Forces), either in port
or underway, are considered deployed medical units supporting the
ship’s operational mission
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Center for
Clinical Laboratory Medicine
Deployable Lab Requirements
• Chapter 16 lists minimum CLIP requirements for
deployed labs
–
–
–
–
–
Maintain verification of training and competency of personnel
Maintain an SOP for each test performed
Maintain and document QC, QA, and maintenance programs
Validate all procedures with the supporting MTF laboratory
Participate in continuing education offered by the
supporting MTF
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Center for
Clinical Laboratory Medicine
Chapter 16 – MTF Support to Deployable Labs
•
•
•
•
•
Assign a technical consultant to each unit
Conduct an annual assistance visit to each unit
Provide training as necessary
Establish internal proficiency testing, as needed
Verify a deployable unit’s ability to perform all
listed procedures
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Center for
Clinical Laboratory Medicine
CLIP Certificate Complexity Levels
• Complexity levels of CLIP certificates correspond to the complexity
of testing performed
–
–
–
–
Minimal Complexity
Provider Performed Microscopy
Moderate Complexity
High Complexity
• POCT can be of any complexity level of testing!
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Center for
Clinical Laboratory Medicine
CLIP Certificate Complexity Levels (cont)
• Higher complexity certificates allow the performance of tests of
lower complexity without the need to obtain another CLIP certificate
– Labs with a high complexity certificate can perform any mix of tests of
high, moderate, or minimal complexity
– Labs with a moderate complexity certificate can perform any mix of tests
of moderate or minimal complexity
– Labs with a PPM certificate can also perform minimal complexity tests
• Must administratively control the segregation of testing personnel as to who
is allowed to do what testing - PPM must be limited to performance by
providers ONLY
– Labs with a minimal complexity certificate are restricted to performance
of minimal complexity tests only
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Center for
Clinical Laboratory Medicine
Types of CLIP Certificates
• Certificate for Minimal Complexity
– Chapter 3
• Certificate for Provider Performed Microscopy
– Chapter 4, specifically para 4-3
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Center for
Clinical Laboratory Medicine
Types of CLIP Certificates (cont)
• Registration Certificate
– Chapter 4, specifically para 4-2
– Chapter 5, specifically para 5-2
• Required of all laboratories seeking a Certificate of Accreditation
• Certificate of Compliance
– Chapter 4, specifically para 4-4
• Certificate of Accreditation
– Chapter 5
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Center for
Clinical Laboratory Medicine
Certificate for Minimal Complexity
•
Per Chapter 2, paragraph 2-3e, minimal complexity testing sites must:
– Follow the manufacturer’s instructions for performing the test(s);
– Meet the requirements in Chapter 3, Certificate for Minimal Complexity
– Analyze and document the results of controls for the test(s) as recommended by
the test manufacturer (retain records for 2 years)
– Ensure that training to properly perform the test(s) is documented for each
employee (new employee requirement – training and documentation of
competency required initially, at 6 month point, and at 12 months post-hire;
documentation of training for new requirements and annual competency
assessment for all tasks performed required thereafter; retain records for term of
employment plus two years; includes providers if testing involves use of
instrumentation)
– Participate in a proficiency testing program when a program for the test(s)
performed is commercially available (NEW – requirement in 1 Sep 2007 revision
to AFIP Pam 40-24; retain records for 2 years)
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Center for
Clinical Laboratory Medicine
Certificate for Provider-Performed Microscopy
– Tests are a subcategory of moderate complexity tests
– Must be performed by a provider (i.e., physician, PA,
NP, nurse midwife, or dentist) during the patient’s visit
• Competency assessment is required for all testing personnel,
including physicians
– CAP (POC.09600) – annual competency assessment is not
required; frequency is at the discretion of the laboratory
director
– TJC (HR.3.10) – all staff who perform testing, including all
physicians, dentists, and midlevel practitioners performing
PPM, must participate in competence demonstrations
37
Center for
Clinical Laboratory Medicine
Certificate for Provider-Performed Microscopy
(cont)
– If PPM tests are to be performed by anyone NOT a
provider:
• PPM tests are a subcategory of moderate complexity tests
• When performed by other than a provider, the tests revert
back to their moderate complexity categorization
• i.e., a moderate complexity level certificate IS REQUIRED
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Center for
Clinical Laboratory Medicine
Certificate of Registration
– Allows start of testing for a new moderate or high complexity
laboratory
– Is not renewable
– Must subsequently obtain a Certificate of Compliance or
Certificate of Accreditation
– Laboratories performing only minimal complexity tests, PPM
procedures, or any combination of these tests are not required to
obtain a registration certificate
• By CLIA/CLIP (AFIP Pam 13-3a) – A laboratory that has been issued a
certificate for minimal complexity or a certificate for provider-performed
microscopy is not subject to biennial inspections
39
Center for
Clinical Laboratory Medicine
Certificate of Compliance
– Must be obtained before Certificate of Registration
expires
– Compliance inspection performed by CLIP Office or
designee using conditions and standards as stated in
AFIP Pam 40-24
– Seldom (if ever) used
40
Center for
Clinical Laboratory Medicine
Certificate of Accreditation
– Must be obtained
• Within 11 months of the issuance of a Certificate of
Registration, or
• Prior to the expiration of a Certificate of Compliance
– Accreditation inspection performed by a CMSapproved, private, non-profit accreditation
organization (as listed on the CMS CLIA web page,
e.g., CAP, TJC, COLA, AABB, etc.)
41
Center for
Clinical Laboratory Medicine
CLIP Certificates (cont)
• Good for a 2-year period of time – NO
EXCEPTIONS!!!
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Center for
Clinical Laboratory Medicine
CLIP Certificates (cont)
• Notify CLIP and accreditation program within 30 days of
changes in:
– Director of laboratory
– Name or physical location of laboratory
– Test menu
• CAP Standards for Laboratory Accreditation
– Laboratories undergoing a change in directorship, location, ownership,
or scope of service are subject to inspection and reevaluation in
accordance with applicable policy.
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Center for
Clinical Laboratory Medicine
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Clinical Laboratory Medicine
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Center for
Clinical Laboratory Medicine
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Center for
Clinical Laboratory Medicine
Single or Multiple Labs per CLIP Certificate?
• A lab must file a separate certificate for each lab location
• Exceptions to the single lab per certificate rule:
– Labs not in a fixed location may be covered under the certificate of a
designated primary site or home base, using its address
• health screening fairs, mobile vans, other temporary testing locations
– Labs engaged in limited public health testing
• No more than a combination of 15 moderate or minimal complexity tests per
certificate
– Labs under a single hospital/clinic commander and supervised by a
single laboratory director may file a single application or multiple
applications
• Used most often with POCT – multiple waived testing sites or PPM sites in a
hospital listed on one CLIP certificate
47
Center for
Clinical Laboratory Medicine
Single or Multiple Labs per CLIP Certificate?
• A laboratory director may direct no more than 5 laboratories
performing moderate complexity testing (including the subcategory
of PPM procedures), high complexity testing, or a combination of
moderate (including PPM) and high complexity testing
– Laboratories in this case means certificates
– Contact your Service CCLM representative for special circumstances
48
Center for
Clinical Laboratory Medicine
Application Requirements - Initial Application
• Registration
– Initial snapshot of facility
• Type of laboratory (complexity)
• Director, by name (NOTE: Lab Director named on CLIP
certificate is the same as the Lab Director identified to
the accrediting organization; position of Medical Director
is not recognized within CLIA/CLIP)
• Identification of numbers of testing personnel by educational
level
• Test volume and methodology
49
Center for
Clinical Laboratory Medicine
Application Requirements - Initial Application
(cont)
– Use forms on AFIP CCLM webpage:
http://www.afip.org/consultation/CCLM/index.html
– Cover sheet of the Registration Form signed by:
• The laboratory director (i.e., individual whose name will be placed
on the CLIP certificate and identified to the accreditation agency as
the lab director)
• The commander of the hospital or clinic
• Signature attests that the laboratory will be operated in accordance
with AFIP Pam 40-24
50
Center for
Clinical Laboratory Medicine
Application Requirements - Initial Application
(cont)
– Information in Section I of the Cover Sheet of the Registration
Form is to provide demographic information for the
ORGANIZATION having oversight of the testing site/sites that
will be listed on the CLIP certificate
• The remaining sheets/sections of the Registration Form collect
information specific to the testing site/sites that will be listed on
the certificate
– Different buildings?
» Should be the same ONLY IF in the same physical location
– Different telephone numbers?
» Should be the same ONLY IF a central point-of-contact is to be used for all
communications
51
Center for
Clinical Laboratory Medicine
Application Requirements - Initial Application
(cont)
– Provide all required information – most importantly,
•
•
•
•
•
Complete lab director information;
name, physical address, and telephone number of lab;
identification of tests performed and the methodology used;
total annual testing volume of all tests performed; and
testing personnel information
52
Center for
Clinical Laboratory Medicine
Application Requirements – Renewal Application
– A Certificate of Registration is NOT renewable
• Must transition to Certificate of Accreditation
– Use forms on AFIP CCLM webpage:
http://www.afip.org/consultation/CCLM/index.html
– Signed by the laboratory director and the commander of the
hospital or clinic
– Provide all required information
53
Center for
Clinical Laboratory Medicine
Application Requirements – Renewal Application
(cont)
– Submit verification of CLIP compliance
• Copy of accreditation letter from CAP, TJC, COLA, AABB,
etc.
– Required for ALL moderate or high complexity certificates
– TJC
» recognizes CAP and COLA accreditation in lieu of their own
laboratory survey but does not grant dual accreditation
» does NOT accredit PPM or waived testing sites
– Navy autogenerates renewal process upon receipt of
accreditation notice from accrediting agency
54
Center for
Clinical Laboratory Medicine
Application Requirements – Renewal Application
(cont)
– Submit verification of CLIP compliance (cont)
• For TJC inspected Certificate for PPM or Certificate for Minimal
Complexity sites (i.e., are not accredited by CAP or COLA)
– memorandum signed by the commander (or his/her designee) stating
that the laboratory is in compliance with the provisions of the CLIP
– Copy of TJC’s
» Accreditation letter for the MTF/Health Care Organization (HCO)
» Accreditation Quality Report for the MTF/Health Care Organization (shows
all sites in the HCO that were surveyed)
» Documentation that these sites were identified to TJC surveyors (copy of
survey application, etc.)
– TJC inspects, but does not accredit, PPM or waived testing
sites
55
Center for
Clinical Laboratory Medicine
Application Requirements – Renewal Application
(cont)
– Submit verification of CLIP compliance (cont)
• For non-accredited, non-TJC inspected Certificate for Minimal
Complexity sites (i.e., MEPS, ANG, etc.)
– memorandum signed by the commander (or his/her designee) stating
that the laboratory is in compliance with the provisions of the CLIP
– a completed self-assessment checklist (NEW – requirement is in the 1
Sep 2007 revision to AFIP Pam 40-24)
56
Center for
Clinical Laboratory Medicine
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Center for
Clinical Laboratory Medicine
Specific Certificate Registration Form Submission
Requirements
• Minimal Complexity
– Cover Sheet (Worksheet 1) and Minimal (Worksheet 2)
• PPM
– Cover Sheet and PPM (Worksheet 3)
• Moderate and High Complexity
– Cover Sheet, Mod High Site Info (Worksheet 4), Mod High Test
Personnel (Worksheet 5), and Mod High Test Volume (Worksheet 6)
• Mod High Site Info page (Worksheet 4) required only if multiple sites will be
listed on the certificate
• Mod High Test Personnel and Mod High Test Volume pages are submitted
as a set for each testing site to be listed on the certificate
58
Page 1 – Cover page
Must be completed for all
applications for initial
registration/re-registration
Contains general info about
the laboratory
When submitted, must be
signed by director and
organization commander
One cover sheet submission
equals/corresponds with one
CLIP certificate action.
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
Must enter lab information for each
site
Page 4 – Multiple sites
(Mod/High complexity)
Used only for a mod or high
certificate with multiple sites
Must enter lab information for
each site
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
(Personnel Information
sections currently not
required)
- Applications must also be
accompanied with a CV for
the director
Center for
Clinical Laboratory Medicine
Page 6 – Moderate or High
Complexity
This page addresses specialties,
test volumes, and
analytes/instrument/methods
Page 5 and 6 are submitted as a
set for each testing site listed on
a moderate or high complexity
CLIP certificate
Center for
Clinical Laboratory Medicine
Inspection Requirements
• A laboratory issued a Certificate for Minimal Complexity or
Certificate for PPM is not subject to biennial inspections, BUT
– for MTFs surveyed by TJC, all minimal complexity and PPM
testing sites must be:
• inspected/accredited by an accrediting organization granted
deeming authority by TJC (i.e., CAP, COLA)
• inspected (TJC does not accredit minimal complexity or PPM labs)
by TJC during the MTF’s survey as one on the services provided by
the MTF
– MUST ensure TJC surveyors are aware of all such non-accredited
testing sites
– MUST correctly answer laboratory service-related questions in the
MTF’s JC survey application to ensure the surveyors are aware
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Center for
Clinical Laboratory Medicine
Inspection Requirements
• Moderate and High complexity testing sites must be
inspected biennially
– If elect to have your PPM and Minimal Complexity testing sites
inspected/accredited by CAP or COLA, then they are also
inspected biennially
• Accrediting organizations have moved to unannounced
inspections
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Center for
Clinical Laboratory Medicine
CLIP Program Requirements
• Personnel standards – defined qualifications within each category of
testing (with the exception of minimal complexity)
– PPM (lab director and testing personnel)
– Moderate (lab director, technical consultant, clinical consultant, and
testing personnel)
– High (lab director, technical supervisor, clinical consultant, cytology
general supervisor/general supervisor, and cytotechnologist/testing
personnel)
• Role of all personnel in laboratory should be defined in writing
– Specify highest role an individual qualifies for – he/she then qualifies for
any role below that level (clinical consultant an exception to this)
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Center for
Clinical Laboratory Medicine
CLIP Program Requirements (cont)
• Facility Administration (facility requirements;
requirements for transfusion services; retention
requirements for records, slides, blocks, and
tissues)
• Quality System (general laboratory systems;
preanalytic systems; analytic systems; and
postanalytic systems)
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Center for
Clinical Laboratory Medicine
CLIP Program Requirements (cont)
• Procedure Manuals
– Clinical Laboratory Standards Institute (formerly
NCCLS) GP2-A5 is mentioned as a reference in the
notes to CAP checklist questions pertaining to
procedure manuals
• CAP states that ‘The specific style and format of procedure
manuals are at the discretion of the Laboratory Director’
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Center for
Clinical Laboratory Medicine
CLIP Program Requirements (cont)
• Proficiency Testing
– Mandatory for moderate and high complexity tests (nonwaived
testing as specified in CLIA; PPM is nonwaived testing)
• Required for minimal complexity sites in 1 Sep 2007 revision to
AFIP Pam 40-24
– Need to ensure are compliant with accrediting organization
requirements for minimal complexity testing sites (CAP differs
from TJC in their requirements)
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Center for
Clinical Laboratory Medicine
CLIP Program Requirements (cont)
Type of Laboratory
Minimal Complexity
Requirements
Registration, PT (NEW as of Sep
07), and good laboratory practices
(see para 2-3e of Pam)
Moderate (including PPM) &
High Complexity
Registration, PT, Facility Admin,
Quality Systems, Personnel (PPM
restricted to providers; somewhat
limited qualifications for Moderate;
stringent qualifications for High),
& Inspection (with the exception
of PPM)
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Center for
Clinical Laboratory Medicine
CLIP Program Requirements (cont)
• Sanctions (Chapter 14 of Pamphlet) - if a
laboratory is determined to be non-compliant
with CLIP requirements:
– TSG may impose principal sanctions (limitation,
suspension, or revocation of a CLIP certificate)
– TSG or the CLIP office may impose alternative
sanctions (directed plan of correction or directed onsite monitoring)
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Center for
Clinical Laboratory Medicine
Revocation/Suspension/Limitation of
Certificate
• Failure to:
–
–
–
–
–
Meet requirements of CLIP
Meet accreditation requirements
Meet proficiency testing requirements
Permit complaint inspections
Correct deficiencies
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Center for
Clinical Laboratory Medicine
Revocation/Suspension/Limitation of
Certificate (cont)
• Other actions of concern:
– Performing, or representing the laboratory as entitled to perform,
a lab examination or other procedure that is not within a category
of lab examinations or other procedures authorized by it DoD
CLIP certificate
– Intentional referral of PT samples to another laboratory
• Process samples to the extent/scope are capable and report that
result
• DO NOT refer the sample to another laboratory for analysis, even if
that is what you would normally do with a patient sample (e.g., from
an outlying clinic lab to a hospital lab)
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Center for
Clinical Laboratory Medicine
Program Funding
• CCLM centrally contracts for:
– Accreditation inspection costs
– Proficiency testing (surveys)
• Excluding linearity and educational (Army)
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Center for
Clinical Laboratory Medicine
Approved Accrediting Organizations (i.e., granted
Deeming Authority by CMS)
•
•
•
•
•
•
•
•
The Joint Commission (TJC)
College of American Pathologists (CAP)
Commission on Laboratory Accreditation (COLA)
American Association of Blood Banks (AABB)
American Osteopathic Association
American Society for Histocompatibility and Immunogenetics
Exempt States (Washington and New York)
http://www.cms.hhs.gov/home/regsguidance.asp
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Proficiency Testing (PT)
• All laboratories must enroll in a PT program
– CLIA requires PT participation for all non-waived testing (including
PPM) and specifies regulated analytes
– CLIP follows CLIA BUT added the requirement in the 1 September 2007
version of the Pam that minimal complexity testing sites must also enroll
in PT when commercially available
• For each specialty, subspecialty, and analyte or test
• Required only for the test system, assay, or examination used as the
primary method for patient testing during the PT event
– Enrollment strongly encouraged by all Services to cover non-regulated analytes
and back-up methods (i.e., non-primary method) for standardization
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Proficiency Testing (cont)
• PT consists of:
– The testing of unknown samples sent to a laboratory by a CMS approved PT
program - most sets of PT samples are sent to participating laboratories three
times per year.
– After testing the PT samples in the same manner as its patient specimens, the
laboratory reports its sample results back to their PT program.
– The program grades the results using the CLIA grading criteria and sends the
laboratory scores reflecting how accurately it performed the testing.
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Proficiency Testing (cont)
• PT is a tool the laboratory can use to verify the accuracy and
reliability of its testing
– Routine reviews of PT reports by the lab staff will alert them to areas of testing
that are not performing as expected and also indicate subtle shifts and trends
that, over time, would affect their patient results.
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Proficiency Testing (cont)
• Must maintain at least 80% acceptable performance for
each analyte or test procedure (e.g., if 5 challenges are
provided per survey event for an analyte or test
procedure, must have acceptable performance for 4 of
the 5 challenges)
– Some immunohematology PT requires 100% acceptable
performance – ABO group & D (Rho) typing, compatibility testing
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Proficiency Testing (cont)
• Chapter 14 of the CLIP Pamphlet (14-11b)
requires that:
– Upon failure to successfully participate in proficiency
testing, the laboratory will take immediate action
which may include voluntary cessation for the
specialty, subspecialty or analyte that was failed. The
accuracy of testing will be verified within 5 days
of receiving the proficiency testing results.
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Proficiency Testing (cont)
• 1st time failure to achieve 80% (or 100%) acceptable
performance
– Internal investigation to determine cause of inaccurate results
and implementation of necessary corrective action
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Proficiency Testing (cont)
•
Failure in 2 consecutive or 2 out of 3 consecutive events
– Cease testing for the failed analyte or test procedure (immediately upon receipt
of survey evaluation from the PT provider)
– Investigation conducted to determine cause of the inaccurate results and
implementation of necessary corrective actions
– Conduct testing to demonstrate that the corrective actions are effective and
accurate results can be achieved (split sample testing with another laboratory is
the most effective proof)
– Provide documentation of the investigation and all conclusions, the
implementation of corrective action, and the ability to achieve accurate results to
the next higher level MTF’s regional pathology or lab consultant
– Regional pathology or lab consultant will authorize restart of testing upon
agreement that all issues surrounding the proficiency test failure have been
appropriately resolved
– Provide copy of all supporting documentation to the CCLM
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Proficiency Testing (cont)
•
Failure in 3 consecutive or 3 out of 4 consecutive events
– Cease testing for the failed analyte or test procedure (immediately upon receipt
of survey evaluation from the PT provider)
– Investigation conducted to determine cause of the inaccurate results and
implementation of necessary corrective actions
– Conduct testing to demonstrate that the corrective actions are effective and
accurate results can be achieved (split sample testing with another laboratory is
the most effective proof)
– Provide documentation of the investigation and all conclusions, the
implementation of corrective action, and the ability to achieve accurate results to
the next higher level MTF’s regional pathology or lab consultant and the CCLM
– CCLM, in coordination with the MEDCOM Laboratory Program Manager, will
authorize restart of testing upon agreement that all issues surrounding the
proficiency test failure have been appropriately resolved
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Proficiency Testing (cont)
• Frequent causes of proficiency testing failure (other than
an outright incorrect answer)
– Failure to monitor timely receipt of surveys and resultant
degradation of survey materials
– Failure to prepare survey materials for analysis per survey kit
instructions
– Failure to provide correct methodology and/or instrument code
(instrument may be Visual) and other administrative errors
– Failure to return results to proficiency testing provider within the
required time frame
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Proficiency Testing (cont)
• Do (paragraph 7-1b in 1 Sep 2007 revision of AFIP Pam 40-24)
– Monitor survey shipment dates and be proactive concerning delivery
(i.e., check with Mail Room each day beginning two days after
scheduled survey shipment date)
– Rotate testing among all personnel who routinely perform patient testing
– Treat survey samples in the same manner as patient specimens (i.e.,
must be examined or tested with the lab’s regular workload by
personnel who routinely perform the testing in the lab, using the lab’s
routine methods and must test the samples the same number of times
that it routinely tests patient samples)
– Document the handling, preparation, processing, examination, and each
step in the testing and reporting of results for all proficiency testing
samples; maintain documentation for a minimum of two years
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Proficiency Testing (cont)
•
Don’t (paragraph 7-1b in 1 Sep 2007 revision of AFIP Pam 40-24)
– Do not communicate with other laboratories regarding the results of
proficiency testing until after the date by which the laboratory must report
proficiency testing results to the proficiency testing provider
– Do not send proficiency testing samples or portions of samples to another
laboratory for any analysis for which a lab is certified to perform in its own
laboratory (corollary precaution: report PT result to the extent/scope of the
capabilities of your lab – don’t refer PT specimen further!)
– Do not appoint a supervisor or one individual as the sole individual allowed to
perform testing on proficiency test samples (see previous slide; however, one
individual may be appointed to prepare the samples for testing and/or to
complete the proficiency testing report)
– Do not perform duplicate or repeat testing on proficiency testing specimens
unless patient specimens are treated in a like manner
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Clinical Laboratory Medicine
Quality Controls
•
Used to:
– Detect immediate errors that occur due to test system failure, adverse
environmental conditions, and operator performance
– Monitor over time the accuracy and precision of test performance that may be
influenced by changes in test system performance, environmental conditions,
and variance in operator performance
•
•
•
•
Performed as specified in manufacturer’s instructions (identifies control
materials to be utilized and the minimum frequency of use)
Over time, rotate control material testing among all personnel who perform
the test
Test control materials in the same manner as patient specimens
Proper preparation/handling of control materials is critical
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Quality Controls Documentation
• Document quality control testing (control information – lot number,
expiration date, etc.; reagent/kit information – lot number, expiration
date, etc.; results obtained - initial and any re-runs required;
assessment as to whether the control results were within the
acceptable range; any corrective actions taken to resolve out-ofcontrol instances; testing personnel identification)
• Conduct and document supervisory review
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Out-of-control corrective actions (in sequence
order until resolved)
•
•
•
•
•
•
•
•
•
Re-run with same control material
Re-run with new control material
Re-run with new reagents
Try controls/reagents received in a different shipment
Review testing personnel performance to ensure test is being performed correctly
Investigate possible instrument malfunctions
Seek manufacturer or other assistance
Don’t perform tests on patient specimens until test system is demonstrated to be in
control
EXCEPT FOR THE FIRST TWO ACTIONS LISTED ABOVE, ALL PATIENT TEST
RESULTS OBTAINED IN THE UNACCEPTABLE TEST RUN AND SINCE THE
LAST ACCEPTABLE TEST RUN MUST BE EVALUATED TO DETERMINE IF
PATIENT TEST RESULTS HAVE BEEN ADVERSELY AFFECTED
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References
• Public Law 100-578 - CLIA-88
• 42 CFR Part 493 – Centers for Medicare and Medicaid
Services, HHS – Laboratory Requirements
• DODI 6440.2, 20 April 1994
• CMS/DOD MOA dated 14 Jan 2009
• AFIP Pamphlet 40-24 dated 1 September 2007 (DOD
CLIP provides current guidance)
Center for
Clinical Laboratory Medicine
Useful Websites
•
•
•
•
•
•
•
•
•
CMS CLIA web page: http://www.cms.hhs.gov/CLIA/
FDA CLIA web Page: http://www.fda.gov/cdrh/clia/index.html
FDA CLIA test complexity db:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
CDC CLIA web page: http://wwwn.cdc.gov/clia/default.aspx
AFIP web page: http://www.afip.org/
CCLM web page: http://www.afip.org/consultation/CCLM/index.html
CAP web page: http://www.cap.org/apps/cap.portal
TJC web page: http://www.jointcommission.org/
COLA web page: http://www.cola.org/
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General CCLM Office Info
Address:
ARMED FORCES INSTITUTE OF PATHOLOGY
ATTN: AFIP-ZCL (Center for Clinical Laboratory Medicine)
Bldg 54, Room G134
6825 16TH Street NW
Washington, DC 20306-6000
Homepage: http://www.afip.org/consultation/CCLM/index.html
FAX: (202) 782-6022 DSN: 662-6022
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