The Health Care Financing Administration (HCFA) requires written documentation for quality control activities, proficiency testing, procedure manuals, equipment maintenance, test requisitions, test records, test reports, quality assurance activities, corrective actions taken in response to problems, and personnel education, experience, and continuing education.

Personnel Records

The laboratory should have a file for each employee containing a record of education and training that qualifies him or her for the position he or she holds in the laboratory. Records of continuing education for laboratory personnel should also be included.

Procedure Manual

The procedure manual should contain instructions for performing every test in the laboratory, including instructions for specimen collection and handling if they are not in a separate manual. The procedure manual serves as a ready reference for laboratory staff and should be readily available to them.

Instrument and Maintenance Logs

One way of organizing information on your instruments is to maintain a log for each instrument in the laboratory. The log would contain the name, purchase date, model and serial numbers, warranties, manufacturer's name and phone number, technical service representative's name and number, name and number of the sales representative, and a record of each time the item is serviced. A maintenance log might be kept to help organize your requisite CLIA documentation. This should include the daily, weekly, monthly, and annual maintenance requirements and instrument function checks.

Quality Control

Since instruments can go out of adjustment easily and give false results, quality control (QC) is essential. Several different types of logs and records may be necessary to help keep track of QC activities required by CLIA. For example, the laboratory could have a log for each test and its controls and a log reflecting any problem with controls, including how the problem was corrected. Graphs depicting accuracy and precision for each test are also an excellent way to monitor your QC activities.

Temperature and Humidity Logs

Before testing specimens, laboratory staff should record the room temperature and humidity of the laboratory daily if temperature and humidity affect the instruments or kits being used. Also, the temperatures of temperature-dependent equipment, such as refrigerators, freezers, incubators, waterbaths, heat blocks, etc., should be recorded in the temperature and humidity log.

Test Tracking System

The test tracking system is the laboratory's method for keeping track of a given test throughout the testing process. Included in the test tracking system are test requisitions, test records, and test reports.

Proficiency Testing Records

HCFA requires that every laboratory keep detailed records of its participation in proficiency testing (PT).

Quality Assurance

The CLIA Fact Sheet titled Quality Assurance in the Laboratory details specific quality assurance (QA) activities which should be performed. All QA evaluations of individual test systems should be documented.

Storing the Laboratory's Documentation

Keeping records in an orderly fashion so that they can be promptly retrieved by the laboratory director, laboratory consultant, and other laboratory personnel reflects the general organization of the laboratory and is imperative to the operation of a laboratory. All QC records should be maintained for at least two years (five years for immunohematology and ten years for pathology test reports).

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