Transcript Laboratory Regulations

LABORATORY
MANAGEMENT
REVIEW 2008
Adapted from Tim Hamill, M.D.
Federal Agencies Impacting
Laboratories
• Department of Health & Human Services (DHHS)
• CLIA
• Center for Medicare & Medicaid Services (CMS)
(Formerly HCFA)
• Office of the Inspector General (OIG)
• Food & Drug Administration (FDA)
• Federal Occupational Safety & Health
Administration (OSHA)
CLIA
Clinical Laboratory Improvement Amendment
• CLIA ‘67 came first
• Under HCFA (now CMS) recommendations the
federal government enacted CLIA ’88
• Took effect Sept. 1992
• Regulations set forth in 42CFR493
• Set minimum standards under which ALL laboratories
would operate
• Available on-line at:
http://www.cdc.gov/clia/regs/toc.aspx
CLIA Laboratories
• CLIA defines what a ‘Laboratory’ is and specifies those
labs that do not come under CLIA
• Laboratories operated by federal & state agencies
• Veterans Administration
• Military
• Public health laboratories
• SAMSHA (NIDA) drug testing laboratories
• Laboratories doing only forensic testing
• Research laboratories IF the results of tests are not released for
use in patient care decisions
CLIA Test Complexities
• Application of CLIA standards is based on
the highest ‘complexity’ of testing
performed by each laboratory
• Waived
• Moderately complex
• Provider performed microscopy (PPM)
• Highly complex
2006 CLIA Laboratory Statistics
88% of labs perform ≤ 25,000 tests/yr
0.3% of labs perform > 1M tests/yr
Criteria Used to Evaluate Test
Method Complexity (score 1-3 for each criteria)
1 Knowledge
2 Training and experience
3 Reagent and material preparation
4 Characteristics of operational steps
5 Calibration, QC, PT materials
6 Test system troubleshooting
7 Interpretation and judgment
*<=12 moderate complexity, >12 high complexity
Waived Testing
• Test methods waived from regulatory oversight
• Tests cleared by FDA for home use
• “Tests using such simple and accurate
methodologies that the likelihood of erroneous
results is negligible”
• 1992: dip u/a, fecal occult blood, urine preg &
ovulation tests, ESR, home devices for blood
glucose, hgb by copper sulfate, spun hct
Waived Testing
• 1997 Waived test program expanded –
result is 10-fold expansion in number of
waived tests
(http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf):
• Any test listed
• Manufacturer may apply for waived status for
any test system that meets criteria
• Test systems cleared by FDA for home use
Waived Testing
• What does it mean if your physician office
lab performs only waived testing?
• No specific personnel or quality control
requirements other than to follow the
manufacturers’ directions
• No inspection unless there is a complaint
• Still need a waiver certificate
Waived & PPM Testing: Problems
for the Hospital Clin Lab
• Many/most POC tests are “waived”
• Providers, clinics, OR, etc. want to perform
these tests in their locations
• If it is under our CLIA certificate, it is
subject to all of our requirements and
inspections including state, VA, JC, CAP,
FDA, etc.
Moderately Complex Tests
• Provider Performed
Microscopy
• KOH
• Wet mount
• Urine sediment
• Qualitative semen
• Ferning
• Post-coital exams
• Pinworm
• Nasal Leukocytes
• Fecal Leukocytes
• Automated hematology
• Automated Chemistry
• UA: automated w/
microscopic
CLIA Certificates
• Certificate of Waiver
• For labs only performing waived tests
• Good for 2 years
CLIA
Certificate
• Certificate of PPM
• For labs performing PPM and/or waived tests
• Certificate of Registration
• Good for 24 months or until inspected
• Not required for Labs doing only waived tests or PPM
CLIA Certificates
• Certificate of Compliance: Issued by CMS after passing a
CLIA inspection
• Certificate of Accreditation: Issued after passing an
inspection by a ‘deemed’ agency
• Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
• College of American Pathologists (CAP)
• Commission on Laboratory Accreditation (COLA)
• American Association of Blood Banks (AABB) (blood banks and Transfusion
centers only)
• American Society for Histocompatibility and Immunogenetics (ASHI)
• American Osteopathic Association (AOA)
Types of CLIA Certification
CLIA: Personnel
• Director, technical supervisor, clinical
consultant, general supervisor, testing
personnel
• Director: overall responsibility, must be
MD/DO/podiatrist or PhD in some cases
(need MD in clinical consultant role)
• Clinical consultant: clinician or PhD
CLIA: Proficiency Testing
• Successful PT requirement for maintaining CLIA
certificate of compliance
• If no commercial PT available, must do split sample
comparison with another internal method or outside lab
• Minimum performance limits for each test in 3 PT events
per year
• PT samples must be treated same as patient samples: no
referrals!
• PT failures: investigate and correct
• If you fail same analyte 2 of 3 consecutive PT events,
subject to sanctions. After PT failure, must have 2
successful surveys to be “out of danger”
Case: Proficiency Testing
CLIA: Quality Systems
• Maintain quality in preanalytical, analytical,
and postanalytical phases of testing
• “Establish and maintain written policies and
procedures that implement and monitor
quality systems”
CLIA: Procedure Manual
• Failure to follow manufacturers’ directions is #1
deficiency in any inspection
• SOPs must be available for all testing procedures
• Manufacturer product insert may be used to
partially meet requirement, but…
• Include: patient prep, specimen collect,
instrument calibration, reportable range, qc,
reference intervals (range), panic values, reporting
CLIA: Test Validation
• Applicable to tests placed into use after 9/1/92
• FDA approved test:
• Accuracy
• Precision
• Reportable range
• Verify manufacturer’s normal (reference) range
• Test performs as expected at your site
Test Validation
• Modified FDA or “Home Brew” (LDA)
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Accuracy
Precision
Analytic sensitivity
Analytic specificity
Reportable range
Reference range
Other performance characteristics
• Specimen Stability
• Interferences
• Establish that modification has not changed test characteristics or
performance
Test Validation Checklist
Version Date 6/7/07
NEW TEST APPROVAL SIGN -OFF
DATE SUBMITTE D FOR REVIEW: _______________
T EST : __________________________________
________________________________________
CIRCLE ONE:
FDA AP P ROVED
FDA MODIFIED
HOME BREW
AT T ACH COP IE
S OF ALL VALIDAT ION DATA
REVIEW AND APP ROVAL: INDICATE AP P ROVAL OF ITEMS WITH ŅOKÓ,DATE AND INT IAL WHEN REVIEW WAS
P ERFORMED
ACCURACY
PRECISION
LINEARITY
RPT RNG
SENSIT IVITY
SPECIFICITY
INT ERFERENCE
REF RNG
PROCEDURE
DATE
INITIALS
DATE
INITIALS
SECTION
DIRECT OR
T ECHNICAL
DIRECT OR
QC SPEC
LABORAT ORY
DIRECT OR
ST ABILITY
REPORT S/
UCARE
CAP TEST
MENU
CHG FORM
SECTION
DIRECT OR
T ECHNICAL
DIRECT OR
QC SPEC
LABORAT ORY
DIRECT OR
DUP LICATE ALL VALIDAT IONDAT A AND T HIS REVIEW SHEET WHEN COMP LETE. ONE COP Y T O BE RET AINED BY
T HE T ESST ING SECTION AND T HE OT HER BYT HE QC DEP ART MENT FOR T HE ENTIRE T IME THE ASSA Y IS IN USE
P LUS 3 YRS.
Validation
• Validate procedures
• You wrote it, can somebody else follow?
• Validate computer software
• Formalized testing using “scripts” to ensure that
performance of each function is as expected
• Document (print) and save
• Validate equipment
• Install after biomed engineering checks
• Check that it performs per manufacturers specifications in
manual
CLIA: Quality Control
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Should detect immediate problems and monitor accuracy and precision over
time
Perform & document Quality Control
• 2 levels every 8 hrs or with each run for all quantitative tests
• Positive & negative controls with each run for all qualitative tests
• Titered: include titered reactivity control
• Extraction process: include extraction controls
• Molecular tests: include inhibition controls
• Microbiology: control checks on media, stains, discs, etc.
• After reagent changes and before testing patient samples
• As patient samples and rotate among operators
• For quantitative controls compare values to statistically derived mean and
standard deviation must be monitored over time to detect trends
“Equivalent or Alternate QC”
• Recognition that 1992 QC regulations were out of
date
• 2004 new alternate QC proposed:
• Combine Moderate & High complexity QC as ‘NonWaived’ QC
• Tests systems identified by FDA as applicable for
alternate QC
• Manufacturer instructions
“Equivalent or Alternate QC”
• Example Option 1: Systems w/internal system to
check all analytic components
• Successful daily internal checks
• Successful testing of 2 levels of control each day x 10 days
• Change QC to:
• Test external controls 1x per month and daily internal
check
CLIA: Inspection
• Sites performing nonwaived testing must be
inspected every two years
• “Deemed” organizations: CAP, JC, COLA,
AABB
CLIA ‘88
• Proficiency testing
• Method performance
• FDA* vs. Modified or
Home Brew
• Gen. Lab success rate 80%,
Blood bank 100%, Cytology
90%
• Applies to all non-waived
tests introduced after 1992
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• Quality Control
• Changed in 2004 “Equivalent QC”
• Other:
• Facilities
• Test methods & equipment
• Reagents, materials,
supplies
• Procedure manual
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Accuracy*
Precision*
Analytic sensitivity
Reportable range*
Reference range*
Stability
Interference
Calibration
Quality improvement
Certification & inspections
Maintenance Checks
Comparability of Results
Inspection Agencies
• College of American Pathologists
• Joint Commission for Accreditation of
Hospital Organizations
• Commission on Laboratory Accreditation
• American Association of Blood Banks
OSHA
• Workplace safety
• Sharps
• Universal Precautions
• Blood Bourne
Pathogen Standard
• Engineering Practices
• Work Practice Controls
• Personal Protective
Equipment
• Exposure Control Plan
• Housekeeping
• Hepatitis B vaccine
Special Situations
• Signs
• Training
• Chemical Hygiene
Plan
• CalOSHA
Safety
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Safety manual
MSDS
Exits & maps
Fire drills &
extinguishers
• Eyewashes
• Protective gear
• How to call for help
Food & Drug Administration
• Oversight of instruments or test kits that are
‘marketed’ to labs for testing
• Pre-market approval process
• Incomplete assays
• Bulk reagents
• Analyte specific reagents (ASR’s)
• Lab Developed Assays (LDA’s)
• IVDMIA’s
CMS office of the Inspector
General (OIG)
• OIG Model Compliance Plan for Laboratories
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Written Compliance plan
Compliance Officer
Staff education & training programs
Audits to monitor compliance
Corrective actions
Compliance Committee
Billing
Annual Notices
Utilization monitoring
Training
Advanced Beneficiary Notice
Human Resources
• Staffing Levels
• Benchmarking
• Internal v. Peer group
• Variable v. Fixed
• FTE monitoring reports
• New programs
Hiring
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Search process*
Screen Resumes
Conduct Interviews
Complete Reference Checks
Complete Background Checks
License Validation
Job Offer & Negotiations
Labor Relations
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Probationary Period
Performance Evaluations
Disciplinary Actions
Terminations
Unions
Personnel
• Job descriptions
• Initial training
• 6 month
competency for
new employees
• Competency
assessment
including direct
observation