Section-Specific Policies and Procedures
A. Clinical chemistry
Policy:
All chemical analyses must meet the DOH accreditation requirements,
including proper calibration, reagents, verification, and quality control.
Procedure:
1. Specimen Verification
- Confirm patient identification and specimen integrity.
- Follow DOH-approved specimen collection and handling protocols.
2. Test Execution
-Use DOH-licensed reagents and properly maintained analyzers.
-Run internal quality controls daily, and document results.
-Re-run tests if controls are out-of-range or if instrument errors occur.
3. Result Recording and Storage
-Interpret results according to reference intervals and DOH standards.
-Record and report results promptly and accurately in logbooks or enter
test results in a soft copy file immediately after testing.
4. Quality Assurance
-Participate in DOH-recognized external quality assessments (EQA)
programs
-Maintain logs of instrument calibration, preventive maintenance, and
reagent lot verification.
B. Serology
Policy:
All serology test must be performed in accordance with DOH licensing
requirements, using validated kits, approved reagents, and trained personnel to
ensure accuracy and reliability.
Procedure:
1. Patient Verification & Specimen Acceptance
-Confirm patient identity and proper labeling of specimens.
-Reject specimens that are hemolyzed, clotted, or otherwise unsuitable .
2. Test Performance
-Use DOH- approved reagents and follow the manufacturer's
instructions.
-Include internal quality controls (positive/negative) with every run.
-Document calibration and Maintenance of instruments.
3. Results Interpretation & Reporting
- Document results in laboratory logbook or enter results in a soft copy
file as duplicate records.
- Save file in secure folder with proper naming conventions.
- Keep a backup copy to prevent data loss.
4. Quality Assurance
-Participate in external proficiency testing (NEQAS or DOH- recognized)
-Document any deviations and corrective actions.
C. Hematology
Policy:
Hematology tests must comply with DOH licensing standards, ensuring reliable
results for complete blood counts and other hematologic analyses.
Procedure:
1. Specimen Verification
-Check patient identity, specimen labeling, and anticoagulant use.
-Reject specimens that are clotted or improperly collected.
2. Test Performance
-Run automated analyzers or manual counts according to SOP.
-Perform daily QC and repeat test if controls are out-of- range.
3. Result Recording and Storage
-Interpret results according to reference intervals and DOH standards.
-Record and report results promptly and accurately in logbooks or enter
test results in a soft copy file immediately after testing.
4. Quality Control & Competency
-Maintain daily QC logs.
-Conduct perioidic staff competency assessment.
-Ensure all instrument are calibrated and maintained per DOH standard
D. Clinical Microscopy
Policy:
Microscopy procedures for urine, stool, and other body fluids must comply with
DOH standards for specimen handling, test accuracy, and reporting.
Procedure:
1. Specimen Handling
-Verify patient information and specimen labeling.
-Follow DOH guidelines for collection, preservation, and transport.
2. Microscopic Examination
- Prepare specimens per DOH-recommended methods.
- Examine slides at appropriate magnifications (e.g., 10x, 40x)
- Document findings with standardized descriptions.
3. Result Recording and Storage
- Record all findings in logbook
- Report critical results (e.g., parasites, abnormal casts) promptly.
- Save in organized folders with proper naming convention and backup.
- Retain slides as required for DOH inspections or confirmatory testing.
4. Quality Control & competency
- Perform daily QC on microscope and reagents.
- Conduct regular staff competency checks.
REFERENCES FOR DOH COMPLIANCE
DOH Administrative order (AO) No. 2020-0052- Licensing and Regulation
of Clinical laboratories
Philippine Clinical Laboratory Standards (DOH BUREAU OF HEALTH
FACILITIES AND SERVICES)
ISO 15189: Medical laboratories- Requirements for quality and
competence
Manufacturer’s Instruction for Use (IFU)
