Authority
- Issued to implement R.A. 4688 (Clinical Laboratory Law) and its Revised Rules and Regulations (A.O. 49-B, s. 1988).
- Consistent with E.O. 119 (Reorganization Act of the Ministry of Health).
Purpose
- Protect and promote public health by preventing operation of substandard clinical laboratories.
- Improve quality of clinical laboratory examinations.
- Enable the Bureau of Research and Laboratories, Department of Health, to evaluate compliance for license issuance.
Scope
- Applies to primary, secondary, tertiary hospital clinical laboratories and free-standing (non-hospital) clinical laboratories.
Classification of Clinical Laboratories
- By Function:
- Clinical Pathology (clinical chemistry, hematology, microbiology, parasitology, mycology, clinical microscopy, immunology and serology, immunohematology and blood banking, radioisotope analysis, laboratory endocrinology).
- Anatomic Pathology (surgical pathology, histochemistry, immunopathology, cytology, post-mortem examinations).
- Forensic Pathology (medico-legal examinations).
- By Institutional Character:
- Hospital laboratory operating within a hospital.
- Free-standing laboratory operating independently or as part of a non-hospital activity.
- By Service Extent and Level:
- Primary, Secondary, or Tertiary based on range of exams, manpower, materials, and facilities.
Service Capabilities
- Primary category:
- Routine Hematology (Complete Blood Count and components).
- Routine Urinalysis.
- Routine Fecalysis.
- Gram Staining.
- Secondary category:
- All primary services plus Routine Chemistry (blood glucose, urea, uric acid, creatinine, cholesterol, total protein).
- Tertiary category:
- All secondary services plus blood typing and cross-matching, donor selection, special chemistry, special hematology, culture and sensitivity testing.
Standards - Head of Laboratory
- Must be a licensed physician registered with the Board of Medicine.
- Qualification depends on category:
- Primary: Free-standing managed by physician certified by Philippine Board of Pathology; Hospital lab in absence of pathologist may be managed by physician with 3 months training and authorization.
- Secondary: Managed by certified pathologist; multiple lab management limited if certified; otherwise single lab by non-certified physician with training.
- Tertiary: Managed by certified pathologist; limited management scope.
Standards - Personnel
- Adequate, qualified, and trained personnel during operation hours according to workload.
- Work assignments consistent with qualifications.
- Emergency procedures limited to qualified/authorized staff.
- All professionals must maintain current licenses or certifications.
Standards - Physical Facilities
- Well ventilated, lighted, clean, safe, and sufficient space:
- Minimum area: Primary - 10 sq.m., Secondary - 20 sq.m., Tertiary - 60 sq.m.
- Adequate water supply required.
Standards - Equipment
- Adequate number and appropriate types matching services and workload.
- Compliance with safety requirements mandatory.
- Minimum equipment detailed per category:
- Primary: Basic lab instruments (microscope, centrifuge, hemacytometer, etc.).
- Secondary: Includes refrigerator, photometer, water bath.
- Tertiary: Advanced equipment including blood counters, incubators, autoclaves, microtome for anatomic pathology.
- Equipment maintenance and proper functioning ensured.
Standards - Glasswares, Reagents, Supplies
- Laboratories must provide necessary glasswares, reagents, and supplies per category and services.
Standards - Quality Control
- Comprehensive quality control program mandatory:
- Internal Quality Control (personnel, equipment maintenance, validation of methods, detection of deviations).
- External Quality Control (participation in Bureau's proficiency testing, performance affects license renewal, refusal leads to license suspension/revocation).
Standards - Reporting
- Laboratory requests are consultations between requesting physician and pathologist.
- Reports must bear pathologist or authorized associate's name.
- Reports issued only by pathologist or authorized associate to requesting physician, except in emergencies.
- Effective communication methods required for prompt, reliable reporting.
Standards - Recording
- Adequate system for accurate recording of all test requests and results.
- Filing, storage and accession numbering for easy retrieval and error prevention.
- Reports retained for at least one year; original reports maintained in patient medical records.
- Anatomic and forensic pathology records must be permanently kept with coded patient data.
Standards - Laboratory Fees
- Fees charged shall reflect prevailing rates, considering cost and quality control requirements.
- Professional fees for special procedures are separate from laboratory fees.
Effectivity
- The Bureau Order took effect immediately upon adoption (January 15, 1990).