Transcript DoD Clinical Laboratory Improvement Program (DoD-CLIP)

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• Revised and superseded CLIA'67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
• Incorporated four separate sets of rules for
implementation
• 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
• 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
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)
• 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)
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)
• Inspections and Sanctions - testing
privileges are suspended or revoked for
facilities out of compliance
Overview of DoD CLIP
Requirements
Type of Laboratory
Requirements
Minimal Complexity
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)
– 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.
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
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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 Ship’s 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 manufacturer’s 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 hospital’s 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
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•
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) Do’s
• Enrollment
• Participation
• Evaluation of results
• Investigation of failures
• Corrective actions
• Maintenance of record
Proficiency Testing (PT) Don’ts
• 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%
PT Failures:
Directed 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
Unsatisfactory 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
Unsuccessful 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.
Repetitive PT failures:
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 there’s no “cease testing”
order from CAP. Otherwise CAP will determine when
they can start testing with CCLM concurrence.
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 for
CAP inspections – means CCLM pays
• Automatically receive a final copy of all
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 facility’s CLIP number
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 don’t ,
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
Navy
Air Force
COL Harms
(202) 782-2514
DSN 662-2514
[email protected]
CDR Ciolorito
(202) 782-2267
DSN 662-2267
[email protected]
Maj Catalasan
(202) 782-2582
DSN 662-2582
[email protected]
SSG Wise/SGM
Wojtaszczyk
(202) 782-2468/1642
DSN 662-2468/1642
[email protected]
[email protected]
.mil
HMC Rapisura
(202) 782-2467
DSN 662-2467
[email protected]
MSGT Brown
(202) 782-2585
DSN 662-2585
[email protected]
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