In licensing a tertiary clinical laboratory in the Philippines, what are the standards/requirements
involved in licensing process according to DOH? And what do you think are some common
challenges laboratories encounter along the way?
There are multiple standards and requirements that’s needed for a tertiary laboratory become a fully
functional laboratory. This includes Man Power, Management Responsibility, Physical Plant/
Facilities/ Work Environment, Equipment/Instruments, Reagents and Supplies, and Policies and
Procedures
Under the Manpower are:
. Clear and Organized Registration and Records
. Workload Balancing and Dissemination
. Adequate amount of staffing and qualifications, under this are: Resume, PRC ID and
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Certificate, PSP Board Certificate, Notarized Employment contract, Training Certificates!
Annual Health status (Latest Medical Certificate)
. Authority to Practice. Eg. - The head shall have administrative and technical supervision of
the activities in the laboratory and Documented proof of Supervisory visit at least once a
month or as needed.
Under the Management Responsibilities are:
. Mission,Vision, and Objectives in accordance to RA 4866.
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. License to Operate/Certifications
. Policies and Program Development and Trainings
. Policies for Human Resources, Rules and Regulations, Management Reviews, and Costumer/
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Patient Feedbacks.
In a tertiary type laboratory in the Philippines there are minimum number of personnel that should
be needed for staffing and hours of duty. Their number of hours are different but should be met by
these regulation.
Free standing laboratory – actual number of staff per section
Rotation of 24 hour duty
For tertiary laboratory, only three sections namely Microscopy, Hematology & Clinical Chemistry,
function during PM and night shifts.
Working hours: Minimum of 8 hours, Maximum of 12 hours
Additional staff depends on workload:
(10 minutes/ test )
- Manual testing: 50 tests/RMT/8 hours
- Manual testing: 75tests/RMT/12 hours
- Automated testing: 100 tests/RMT/8 hours - Automated testing: 150 tests/RMT/12 hours
Additional staff for other duties will be determined by the head of lab.
Total number of staff include reliever/s
Under the PHYSICAL PLANT/ FACILITIES/WORK ENVIRONMENT:
. Program of proper maintenance and monitoring of physical plant and facilities
. Policy guidelines on laboratory biosafety and biosecurity
. Procedures for the proper disposal of waste and hazardous/infectious substances that shall
conform to the standards set by the DOH
. Technical Working Area (minimum) As per DM No. 148s. 2003 - 60 sq. meters