Law Summary: DOH Administrative Order No. 2021-0037

The Department of Health (DOH) Administrative Order No. 2021-0037 aims to regulate clinical laboratories in the Philippines by establishing updated guidelines. This Order is in line with Republic Act No. 4688 and the Universal Health Care Act, intended to ensure accuracy, precision, and reliability in laboratory test results. The Order recognizes the essential role of clinical laboratories in healthcare for disease diagnosis, treatment, prevention, and control.

The AO sets forth the requirements for securing a License to Operate (LTO) for clinical laboratories. All clinical laboratories, whether institution-based or not, must secure this license from the DOH and comply with the set standards at all times. The guidelines include specific classifications based on ownership (government or private), institutional character (institution-based or non-institution based), and function (clinical or anatomic pathology). Additionally, there are stringent requirements for the physical plant, personnel, equipment, and service delivery to ensure quality and safety.

Under the service delivery section, the AO mandates that all clinical laboratories must adhere to quality standards and other relevant issuances. Clinical laboratories must also have adequate and operational equipment, maintain a preventive maintenance program, and have a contingency plan for equipment breakdowns. Furthermore, there are provisions for maintaining sufficient and properly stored reagents, glassware, and other supplies.

The AO also emphasizes the need for continuous quality improvement and the importance of participation in an External Quality Assessment Program (EQAP). To ensure confidentiality and compliance, clinical laboratories need a systematic approach to information management, including robust administrative and technical procedures, risk assessments, and communication protocols. The Order specifies penalties for non-compliance, including warnings, fines, and possible revocation of the LTO.

In summary, DOH Administrative Order No. 2021-0037 establishes comprehensive guidelines for the operation and maintenance of clinical laboratories in the Philippines. It aims to enhance the quality and safety of laboratory services while ensuring that all laboratory activities comply with national and international standards.