Book:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/The clinical environment/Good laboratory practices

1.2 Good laboratory practices

As previously stated, the ultimate goal of the clinical laboratory—and by extension, the POL—is to test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. This, of course, requires accurate results to ensure the best result. In the 1970s, the U.S. Food and Drug Administration noted non-clinical laboratories in many cases conceived experiments poorly, failed to inform laboratory personnel of protocol, and didn't regard strict laboratory procedure to be necessary. This brought about the Good Laboratory Practice regulations in November 1976. Clinical laboratories were not left out of this recognition of the need for improvements, however. Though the Clinical Laboratories Improvement Act of 1967 brought about some reforms to laboratory practices, the act wasn't doing enough by the mid-1980s. The regulations were revised and put into effect on October 31, 1988 as the Clinical Laboratory Improvement Amendments of 1988. Known as "CLIA," the regulations have helped shape the policy and procedure of clinical laboratories of all types, including how training and experience is gauged and documented, reagents are prepared, and quality control is approached.

Today in the U.S., like any other clinical lab, physician office laboratories must follow good laboratory practices to ensure the best outcomes for its associated patients. These practices must be engaged in at every stage of the laboratory testing process. During the initial test ordering process, for example, lab personnel must review orders for accuracy and seek verification from the physician if there are any questions. Following order entry, staff should complete a requisition and explain all preparation procedures to the patient. When the patient arrives, staff should use appropriate procedures and containers to collect the specimen(s) from the patient. Processing of the specimen should include proper storage, preservation (if required), labeling, and transportation. The POL must run quality control tests prior to testing the patient sample to ensure instruments are properly calibrated and appropriate testing proficiency is met. After test completion, a laboratory report is printed and the physician notified. Patients should also be notified per the policy of the physician practice. Disposal of laboratory waste is also part of good laboratory practice, as is proper documentation in the patient record regarding testing and results.