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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 available.

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 usually less.

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 month.

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 assessment guidelines.

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!

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