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:
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:
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. The following information is required to be included (CLIA regulations, Subpart K, 493.1211):
Manufacturer’s package inserts or operator manuals may be used to meet the requirement; any information not included by the manufacturer must be included by the laboratory. All procedures must be approved, signed, and dated by the laboratory director. Procedures must be re-approved, signed and dated if the director of the laboratory changes; each change must be approved, signed, and dated by the current laboratory director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance, retaining records for two years after the procedure has been discontinued.
Preparing the procedure manual is typically the most time consuming portion of developing a quality assurance program. It is worth a little extra effort to make sure that it is useful. The design should be determined by the lab’s needs and organization. Some tips include:
In the POL with limited space, it is helpful to use a card index system as a supplement to the procedure manual. This system is an abbreviated form; it should contain the first six elements from Table 1. A copy of each card should be included in the actual procedure manual.
Sources: NCCLS Document GP2-A3, Clinical Laboratory Technical Procedure Manuals, 3rd ed.; The New Poor Man's (Person's) Guide to the Regulations, Laessig and Ehrmeyer
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Clinical Laboratory Improvement Amendments (CLIA)
Preparing a Procedure Manual