Question & AnswerQ&A (KPL BUREAU ORDER NO. 4)
The purpose is to protect and promote public health by preventing substandard operation of clinical laboratories and to improve the quality of laboratory examinations, and to assist the Bureau of Research and Laboratories, Department of Health, in evaluating compliance for license issuance.
The standards apply to primary, secondary, and tertiary hospital clinical laboratories as well as free-standing (non-hospital) clinical laboratories.
Clinical laboratories are classified according to their function (clinical pathology, anatomic pathology, forensic pathology), institutional character (hospital or free-standing), and service extent and level (primary, secondary, tertiary).
A primary category lab must offer routine hematology (including Complete Blood Count), routine urinalysis, routine fecalysis, and gram staining.
Primary free-standing labs are managed by licensed physicians certified in pathology; hospital primary labs can be managed by certified pathologists or physicians trained in lab medicine. Secondary and tertiary labs require management by certified pathologists; in shortage areas, certain physicians authorized by the Bureau may manage hospital labs.
Primary labs need at least 10 square meters; secondary labs require 20 square meters; tertiary labs require 60 square meters of technical working space.
All clinical laboratories must have an internal quality control program to ensure proper maintenance, personnel selection, method sensitivity, and deviation detection, and participate in an external quality assurance program through the Bureau of Research and Laboratories' proficiency testing.
All laboratory reports must be kept in the clinical laboratory for at least one year, with the original report filed in patient medical records. Records of anatomic and forensic pathology must be kept permanently with a coded system using patient data.