Far Eastern University

Institute of Arts and Sciences

Department of Medical Technology
2nd Semester, AY 2020-2021
MTY1207 - Medical Technology Laws and Bioethics (MTLBE)

ASSIGNMENT NO. 2 – Laws on Training and Teaching Clinical Laboratories

Name: Daniela Leung

Section: 16

Instruction: Let’s say you want to establish your own tertiary laboratory, what will be the whole process
before you can successfully start your laboratory. Include the name of the lab, process, materials,
personnels and others.

--ANSWER--

Name of laboratory:

Process: (Write a concise flow of process how to start a tertiary laboratory. Include materials, equipment,
personnels and others.)

When starting a Tertiary Laboratory in the Philippines, these will be the steps by step guide to
follow and the requirements to complete which include Include materials, equipment, personnels and
others.

A. PROCESS
1. Applicants may obtain the required registration application form from the BHFS, DOH
website, or the CHD based on which agency has authority over the current or proposed
clinical laboratory.
2. The completed form, along with the prescribed attachments, must be submitted to the BHFS
or to the CHD, which has authority over the current or suggested clinical laboratory. During
this step, the applicant is expected to pay a non-refundable application fee for a Certificate of
Registration upon submission of the completed form.
3. The BHFS will evaluate the submitted application and will be subjected for the completeness
of the attachments and execution of forms.

B. REQUIREMENTS FOR SERVICE CAPABILITIES OF CLINICAL LABORATORY

- Since we are aiming to start a tertiary laboratory, the service capabilities will be the combined
capabilities of the primary and secondary laboratories which are
 routine hematology (CBC) – hemoglobin mass concentration, hematocrit, WBC and
differential count
 qualitative platelet determination
 routine urinalysis
 routine fecalysis
 blood typing (for hospital-based)
  routine clinical chemistry – including blood glucose, blood urea nitrogen
concentration, blood uric acid substance concentration, blood creatinine
concentration, and total cholesterol count
 quantitative platelet determination
 cross-matching (for hospital-based)
 gram staining (for hospital-based)
 KOH (for hospital-based)
- with an addition of specialized sections namely
 special chemistry,
 special hematology (coagulation tests),
 immunology/serology, and
 microbiology

C. EQUIPMENT/INSTRUMENTS
- Since we are aiming to start a tertiary laboratory, the equipment will be the combined
equipment needed for the primary and secondary laboratories which are
 clinical centrifuge
 hemocytometer
 microhematocrit centrifuge
 microscope with oil
 hemoglobinometer or equivalent
 differential counter or equivalent
 refrigerator
 photometer or its equivalent
 water bath or its equivalent
 timer or its equivalent
- with an addition of
 incubator
 balance
 rotator
 serofuge or its equivalent
 autoclave
 drying oven
 biosafety cabinet (BSC) or equivalent

D. PHYSICAL FACILITIES
1. Enough space should be provided to accommodate people and place the instruments and
furnitures that are need for the laboratory. The laboratory should have
 at least 60 m2 in floor area,
 toilet,
 clinical work area with sink
 pathologist’s area
 microbiology room
2. The clinical laboratory should be well-ventilated, adequately lighted, clean, and safe.
3. The foundation of the clinical laboratory such as walls, ceilings, and fixtures, should be easily
cleaned and should be made of durable materials to withstand fire and other chemical
substances.
 4. Tools for the detection of fire, such as fire alarms in walls, door peepholes or overhead smoke
detectors, shall be in place inside the clinical laboratory. Fire extinguishers or fire hoses shall
be readily available and usable in strategic locations.
5. Liquid waste is dumped into a permitted public wastewater system and solid waste is
collected, processed and disposed of in accordance with regulatory codes, laws, or
regulations.

E. PERSONNEL
1. The head of the clinical laboratory should be a licensed physician that is certified by the
Philippine Board of Pathology.
2. Personnel that will be employed in the clinical laboratory should be qualified and adequately
trained.
 There should be enough number of registered medical technologist for the amount of
workload the clinical laboratory is examining, and they should be present at all times.
On the other hand, there should be at least one registered medical technologist per
shift for hospital-based clinical laboratories.
3. Staff development and appropriate continuing professional development shall be accessible at
all levels of the organization for the continuing enhancement of the knowledge, attitudes and
skills of staff.