CLIA - 10 EASY STEPS TO GET STARTED
1. GET A CLIA REGISTRATION NUMBER
In N.J. - go on the NJ web site: www.NJ.US.Health and print out
instructions and forms for CLIA licencing or call the N.J. Department of
Health and Licencing at (609) 292-0016. Ask for a CLIA #116 form to be sent
to your office. Fill out and send the #116 form to N.J. Department of
Health - CLIA, CN 361, Trenton, N.J. 08625-0361. Do not sent money - you
will be billed for registration and first inspection.
If you are in N.J. go on the NJ web site (www.state.nj/health/phel/clis)
and print instructions and forms (application, personnel, ownership
disclosure) for a N.J. State CLIS liciense. Fill out, copy and return to
N.J. Department of Health - Dept. of Laboratory Licencing, CN 360, Trenton,
N.J. 08625-0360. Do not sent money - you will be billed for licence.
2. JOIN A PROFICIENCY TESTING COMPANY
There are numerous companies to choose from. List is found in your
laboratory manual or a list is attached. Prices vary so it is wise to do a
cost comparisons. Join for all moderate complexity tests that are
If you are in N.J. and office have a CLIS laboratory license make sure the
PT program is a NJ state approved program.
3. CHOOSE BETWEEN PRIVATE INSPECTION OR FEDERAL INSPECTION (Inspection
performed by the State of N.J. for CMA or private inspection by COLA)
The cost of inspection takes into account how many specialties and how many
tests you perform. If you are low volume, a government inspection is
The cost of private inspection is based on how many doctors are in the
practice and how may specialties are performed. To obtain information on
private inspection call COLA at (800) 298-8044.
4. MAKE SURE LABORATORY PERSONNEL FILES ARE COMPLETE
Each person performing tests or filling a CLIA position should have a
detailed job description, record of training, diploma (high school at
minimum), licenses, training, 6 month and 1 year evaluation (then annual),
continuing education, hepatitis record, safety training record.
6. LABORATORY PROCEDURE MANUAL
Procedure manual(s) must have instructions for ALL tests performed.
Procedures must be written to comply with CLIA guidelines. Operator manuals
and package inserts may be used but may need supplementary information to
meet CLIA guidelines. It is best to refer to the Federal Register (Feb. 28,
1992) for what needs to be included. All procedures must be signed and
dated by the director. The manual must also include information of specimen
collection and storage.
7. QUALITY CONTROL
Quality control must be performed and documented according to manufacturer
recommendations or CLIA regulations for all tests. Documentation may be
done by computer (linked to instrument) or manually. COLA will want to see
quality control on Levy-Jenning charts for all instrument performed tests.
The director or technical consultant must sign off on quality control each
8. INSTRUMENT MAINTENANCE
Instrument maintenance includes all routine and additional maintenance
needed. Validation studies must be documented on all new equipment. ALL
routine and manufacturer maintenance must be documented. Calibration must
be performed as recommended by the manufacturer or at minimum, every 6
months (which ever comes first). Maintenance also includes temperature
checks, timer checks, centrifuge checks and pipette calibration.
9. PATIENT TEST MANAGEMENT TRACKING RECORDS
Documentation that includes adequate information on test requisitions
forms, test record (accession logs), turn around time, specimen labeling,
proper test preparation and test reports must be according to CLIA quality
10. QUALITY ASSESSMENT
The office must have a documented system in place that shows how the
laboratory policies they have put in place work. Professionally prepared
quality assessment plans are available but must be personalized to reflect
your personal practice. Document all QA activities!