Preparing a Procedure Manual

Tips on Preparing a Procedure Manual

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. The following information is required to be included (CLIA regulations, Subpart K, 493.1211):

• 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.

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.

Tips for a Useful Manual

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:

• Use a three-ring binder to maintain the document in a format that is easily reviewed and updated.
• Access to a computer for word processing simplifies the process.
• Start each procedure on a new page or a new file for ease in making changes.
• Use tabs or a table of contents for easy reference.
• Use plastic page protectors to extend the shelf-life of the manual.

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