LABORATORY PRACTICE STANDARDS AND GUIDELINES

Any laboratory that performs tests which aid in determining an appropriate treatment or action for an illness or disease must establish practice standards and guidelines. Each laboratory procedure should include criteria for acceptable samples or specimens; a list of equipment, supplies, and reagents required; detailed step-by-step instructions for the testing procedure itself; and a list of the quality control procedures to be included, the results to be reported, and the interpretations of those results. Since some tests may require immediate action, protocol should also include directions on reporting details. Guidelines for reporting results to government agencies as required under local or state laws are also established.

In order to protect individuals and sensitive information, strict confidentiality guidelines should be developed for reporting results. These confidentiality guidelines should include disciplinary actions to be taken if protocols are not followed. Guidelines are also established regarding the interpretation of quality control results and corrections that need to be made if results are not accurate. Additionally, practice standards for the laboratory may include safety procedures to be followed and guidelines for actions to be taken should laboratory accidents occur. In order to document that appropriate actions and procedures have been followed within the laboratory, standard practices should also include guidelines for the length of time that all records and documentation of corrective actions should be kept within the laboratory, and for computer back-up procedures.

Kathleen L. Meckstroth

(see also: Assurance of Laboratory Testing Quality; Diagnostic Testing for Communicable Disease; Laboratory Services; Laboratory Technician; Reference Laboratory )