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RA 4688
Confirmatory testing; surveillance; resolution of conflicting results; training; research; implementation of EQAS; evaluation of diagnostic
kits and reagents
POCT Point of Care Testing (at or near the site of the patient)
Routine Test basic, commonly requested tests
STAT (short turn-around time)Tests urgent tests and to be released within one hour after procedure
Classification of Laboratories
A. Classification by Ownership
Government
Private
B. Classification by Function
Clinical Pathology
Anatomic Pathology
C. Classification by Institutional Character
Institution-based
Freestanding
NO PERSON IN THE LAB SHALL ISSUE A REPORT ORALLY OR IN WRITING WITHOUT THE DIRECTIVE FROM THE
PATHOLOGIST OR HIS AUTHORIZED ASSOCIATE
Inspection/Inspector of a Clinical Laboratory
1. Director for Center for Health Development/BHFS
2. BHFS or the CHD Director or his authorized representative
The LTO shall be issued only to clinical labs that comply with standards and technical requirements formulated by the BHFS
Clinical labs operated and maintained for research and teaching purposes (exempted but needs to be registered w/ BHFS). The
Special clinical labs are required to register w/ BHFS w/o being licensed (if not subject to other AO), NRL-designated by DOH shall be
covered by license of the clinical lab of the hospital
Register only w/ BHFS if physically independent & duly accredited by international certifying body like. CDC (Center for
Disease Control) and WHO (World Health Organization), or local body recognized by DOH (Department of Health)
Procedural Guidelines:
1. Registration for Special Clinical Labs, NRL, Research & teaching Labs
2. Procedures for Application for Initial/Renewal of LTO
3. Renewal of LTO
Hospital-based processed under the One-Stop-Shop Licensure System for Hospitals
Non-hospital based beginning first day of October until end of November of current year (discount on renewal
fee)
Automatic cancellation of LTO
a. Failure to submit duly accomplished form
b. Non-Payment of proper fee on or before expiration date
4. Inspection
CHD shall conduct announced inspections at reasonable time using inspection tool
5. Monitoring
BHFS/CHD Director or rep shall monitor clinical labs
Notice of violation for non-compliant labs shall be issued immediately
CHD concerned shall submit quarterly summary of violations to BHFS
Provincial, City & Municipal Health Officers can report existence of unlicensed labs
Violations
The BHFS/CHD Dir or rep shall investigate the complaint or the BHFS/CHD Dir or rep shall suspend, cancel or revoke & may
seek any law enforcement agency to execute the closure of any erring lab when necessary
Penalty
1. Imprisonment of not less than 1 month; or
2. Fine not less than Php1000 but no more than Php5000; or Both
3. If a corporation- managing head or owner is liable
A. Staffing
1. Managed by licensed Physician certified by the Philippine Board of Pathology
If the licensed Physician certified by the Philippine Board of Pathology not available any physician w. 3
months training on clinical lab medicine, QC & management may manage a primary/secondary lab as
certified by BHFS
2. RMTs should be available at all times during operation hours
Hospital-based lab at least 1 RMT/shift
3. Staff development & CPE program instituted
B. Physical Facilities
1. Well-ventilated, adequately lighted, clean & safe
2. Work space requirements (at least)
Primary - 10 m2
Secondary - 20 m2
Tertiary - 60 m2
C. Glasswares/Reagents/Supplies
D. Waste Management
All labs shall participate in an EQAS (External Quality Assurance) given by designated NRL
Satisfactory performance rating is the criteria for renewal of license
Refusal to participate in EQAS-NRL is a basis for suspension/revocation of license
F. Reporting
1. Bear the name & signature of Pathologist & RMT (Registered Medical Technologists)
2. No report orally or in writing without directive from pathologist or associate except in emergency cases
G. Recording
1. All requests and reports of all specimens submitted and examined
2. Kept in file for at least 1 year
Anatomic and forensic pathology reports are kept permanently
H. Laboratory Fees
Equipment/Instruments
Primary Laboratory Secondary Laboratory Tertiary Laboaratory
Clinical centrifuge All those in 1 plus the ff: All those in 2 plus the ff:
Hemacytometer Refrigerator Incubator
Microhematocrit centrifuge Photometer or its equivalent Balance
Microscope with OIL Waterbath or its equivalent Rotator
Hemoglobinometer or equivalent Timer or its equivalent Serofuge or its equivalent