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CLIA Policy & Procedures " Forms"

CLIA Policy & Procedures " Forms"

CLIA Policy & Procedures

A well-prepared procedure manual provides a foundation for the lab’s quality assurance program. Its purpose is to ensure consistency while striving for quality. The procedure manual may be used to:

Document how tests are performed

Train new personnel

Remind personnel of how to perform infrequently ordered tests

Troubleshoot testing problems

Measure acceptable test performance when evaluating staff

 

The procedure manual should be written at a level that everyone in the laboratory can understand. It must be useful, clear to the user, and available at the bench/work area.

 

All testing personnel should be required to read the entire procedure manual. It is advisable to include a page at the front of the manual where personnel can “sign-off” when they have read the manual. An annual review would benefit the lab personnel and could be included as part of the overall quality assurance program.Include a general policies section addressing lab-specific issues, such as:

The lab’s QA plan

Specimen collection

Specimen labeling

Form completion

Panic value list

Guidelines for releasing results

 

CLIA Requirements

 

All labs must have a written procedure manual for the performance of all tests performed in the lab. The manual must be readily available and followed by laboratory personnel. Textbooks may be used in addition to the procedure manual.

 

Specimen collection, processing, and rejection criteria requirements.

Procedures for microscopic examinations, including the detection of inadequately prepared slides.

Step-by-step performance of the procedure, including test calculations and interpretation of results.

Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing.

Calibration and calibration verification procedures

The reportable range of patient test results as established or verified through method performance specifications.

Control procedures

Remedial action to be taken when calibration or control results fail to meet the lab’s criteria for acceptability.

Limitations in methodologies, including interfering substances.

Reference or normal ranges

Imminent life-threatening lab results or panic (critical) values.

Pertinent literature references

Appropriate criteria for specimen storage and preservation to ensure specimen integrity until testing is completed.

The lab’s system for reporting patient results including, when appropriate, the protocol for reporting panic values.

Description of the steps to be taken in the event that a test system becomes inoperable.

Criteria for the referral of specimens including procedures for specimen submission and handling.

 

This option is only for individuals who are CLIA Waived Laboratories

 

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  • TRAINING INFO

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