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Sr Labservices Policy

The document outlines the policies and procedures for laboratory services, including administrative policies, specimen collection, and handling across various sections such as clinical microscopy, hematology, and clinical chemistry. It emphasizes the importance of quality assurance, safety protocols, and proper specimen handling to ensure accurate test results. Each section details specific procedures for sample collection, analysis, and quality control measures to maintain laboratory standards.

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0% found this document useful (0 votes)
2 views17 pages

Sr Labservices Policy

The document outlines the policies and procedures for laboratory services, including administrative policies, specimen collection, and handling across various sections such as clinical microscopy, hematology, and clinical chemistry. It emphasizes the importance of quality assurance, safety protocols, and proper specimen handling to ensure accurate test results. Each section details specific procedures for sample collection, analysis, and quality control measures to maintain laboratory standards.

Uploaded by

ronnelgomo33
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

POLICY AND PROCEDURES OF LABORATORY SERVICES IN EACH

SECTION

1. Administrative Policies
1.1 Licensing & Authority

Operates under RA 4688 and DOH Administrative Orders AO 2021-0037.


Licensed annually by the Department of Health (DOH).

1.2 Personnel Policy

Only licensed Medical Technologists and authorized laboratory aides are


allowed to perform procedures.
Duties and responsibilities are documented.

1.3 Quality Assurance Policy

Daily Internal Quality Control (IQC) on analyzers.


Participation in National External Quality Assurance Program (NEQAS).
Documentation of QC results and corrective actions.

1.4 Safety & Infection Control

Universal precautions are always observed.


PPE (gloves, lab coats, masks) is mandatory.
Proper disposal of biohazard waste per DOH Health Care Waste Management
Manual.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
2. Specimen Collection & Handling (General Procedures)

Patient identification verified using two identifiers (Name & Birthdate).


Specimens labeled immediately at collection area.
Rejection criteria: unlabeled, hemolyzed, insufficient, or improperly collected
samples.
Specimen logbook entry is completed upon receipt.

3. Clinical Microscopy Section


3.1 Policies

Only fresh and properly labeled specimens are accepted.


Results are verified by an RMT before release.

3.2 Procedures
A. Urinalysis
Instructions for Collection:

1. Females: Clean the area around the urethra (where urine exits the
body) with wipes spreading the labia to expose the area.
Males: Clean the tip of the penis with wipes.
2. Start urination into the toilet, then collect the midstream urine in a
sterile container.
3. Avoid touching the inside of the container or lid.

Analysis:

Test specimen within one hour of collection. If not possible, the sample can
be refrigerated at around 4C for a maximum of 24 hours.
Physical exam: color, transparency, volume, odor.
Chemical exam: dipstick method for protein, glucose, ketones, pH, specific
gravity, etc.
Microscopy: RBC, WBC, epithelial cells, casts, crystals, microorganisms.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
B. Fecalysis

Instructions for Collection:

1. Wash hands and urinate.


2. Pass stool into a clean, dry container or plastic wrap over the toilet,
avoiding water, toilet paper, or urine in the sample.
3. Use the attached scoop or spoon to transfer a small amount of stool
( peanut sized or half the vial for liquid samples ) into the collection
container.
4. Ensure the lid is tightly sealed.
5. Submit to the laboratory within 2 hours of collection.

Analysis:

Test immediately.

Macroscopic: color, consistency, presence of blood/mucus.


Microscopic: direct smear for ova, cysts, trophozoites.

C. Fecal Occult Blood Test (FOBT)

Performed using rapid immunochromatographic kit.


Refer to Instructions of Use by manufacturer.
Positive results referred to physician for further evaluation.

4. Hematology Section
4.1 Policies

Hematology tests performed only on properly anticoagulated blood (EDTA).


Daily QC checks required for analyzer.

4.2 Procedures
A. Complete Blood Count (CBC)
Run samples using DYMIND D55 5-part Hematology Analyzer.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
Perform daily QC using commercial controls.
Record results and verify by RMT.

B. Blood Typing
Performed by slide or tube method with anti-A, anti-B, anti-D reagents.
Confirm Rh typing with weak D test if necessary.

4.3 Hematology Analyzer Procedure

Instructions for Collection:

1. Sufficient human blood sample must be collected in EDTA tube


2. Sample must be properly homogenized before analysis
3. Conduct sample test immediately after collection, if needs to
be stored, must be at 2-8C for no more than 24 hours
4. If sample has been stored, it needs to be equilibrated at room
temperature for 10 minutes before use.

DYMIND D55 5-Part Hematology Analyzer SOP

A. Daily Start-Up Procedure


Step 1: Check the Work Area

1. Ensure the analyzer is placed on a clean, stable, level surface.


2. Check that the power cord, reagent tubing, waste tubing, and
LIS connection are secure.
3. Confirm that the waste container is not full.
4. Ensure there is enough printer paper if using the built-in
printer.

Step 2: Check Reagents

Verify sufficient volume and correct connection of:

1. Diluent
2. Lyse reagent

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
3. Sheath/diff-related reagent, if applicable
4. Cleaner or rinse solution
5. Waste container

Record reagent lot number, expiry date, and date opened in the
reagent logbook.

Step 3: Power On

1. Turn on the main power switch.


2. Wait for the analyzer software to initialize.
3. Allow the instrument to complete self-check/start-up checks.
4. Do not run patient samples until the analyzer status is ready.

Step 4: Perform Background Check / Blank Count

1. Select the background or blank count function.


2. Run the blank/background check as prompted.
3. Review the results.
4. Accept only if background values are within manufacturer or
laboratory-defined limits.
5. If background fails:
o Repeat background check.
o Check reagents and tubing.
o Perform rinse/cleaning cycle.
o Inform the supervisor if still unacceptable.

B. Quality Control Procedure


Step 1: Prepare Control Material

1. Remove hematology control from refrigerator.


2. Allow it to reach room temperature as required by the control
manufacturer.
3. Mix gently by inversion. Do not shake vigorously.
4. Check expiry date and open-vial stability.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
Step 2: Run QC

1. Select QC mode on the analyzer.


2. Choose the correct QC level: Low, Normal, or High.
3. Enter or confirm:
o Control lot number
o Expiry date
o Level
4. Mix the control again gently.
5. Present the tube to the sample probe.
6. Press the aspirate/start button.
7. Wait until analysis is complete.

Step 3: Review QC Result

1. Compare results with the assigned control range.


2. Accept QC only if all required parameters are within range.
3. Record QC result in the QC logbook or electronic QC system.
4. If QC fails:
o Do not release patient results.
o Repeat QC using properly mixed control.
o Check reagent status and expiry.
o Perform cleaning if needed.
o Run a new vial if control deterioration is suspected.
o Document corrective action.

C. Patient Sample Analysis


Step 1: Specimen Acceptance

Accept only properly collected EDTA whole blood samples.

Check:

1. Correct patient identification


2. Proper tube labeling
3. Adequate sample volume
4. No clot

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
5. No gross hemolysis
6. Proper mixing
7. Sample is within acceptable stability period

Reject and document samples that are clotted, unlabeled,


mislabeled, insufficient, or unsuitable.

Step 2: Mix the Sample

1. Gently invert the EDTA tube 8–10 times.


2. Ensure blood is homogeneous before aspiration.
3. Do not shake vigorously.

Step 3: Select Test Mode

Select the appropriate mode:

1. Whole Blood Mode – routine EDTA venous samples


2. Capillary Whole Blood Mode – capillary samples, if validated
3. Prediluted Mode – only when required and validated by the
laboratory

Step 4: Enter Patient Information

Enter or scan:

1. Patient ID
2. Patient name
3. Age/date of birth
4. Sex
5. Physician/requesting unit
6. Sample type
7. Test requested

Step 5: Run the Sample

1. Open the tube cap carefully.


2. Place the sample under the probe.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
3. Ensure the probe is properly immersed in the blood sample.
4. Press aspirate/start.
5. Keep the tube steady until aspiration is complete.
6. Remove the tube only when prompted.
7. Recap the tube immediately.
8. Wait for the result to appear on screen.

Step 6: Review Results

Review:

1. WBC, RBC, HGB, HCT, PLT


2. 5-part differential
3. Histograms
4. Scattergrams
5. Analyzer flags
6. Critical values
7. Delta check, if applicable

Step 7: Result Validation

1. Validate results only if QC is acceptable.


2. Repeat the sample if results are flagged, questionable, or
inconsistent with clinical history.
3. Prepare peripheral blood smear when required by laboratory
criteria.
4. Refer abnormal, critical, or suspicious results to the
pathologist or authorized reviewer.
5. Release results only after verification.

D. Repeat Testing Criteria

Repeat analysis when:

1. Analyzer flags are present.


2. Result is critically high or low.
3. Platelet count is unexpectedly low.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
4. WBC count is extremely high or low.
5. There is suspected clot, platelet clumping, or poor mixing.
6. Histogram or scattergram is abnormal.
7. Result is inconsistent with previous results or clinical
condition.

F. Daily Shutdown Procedure


Step 1: Finish All Testing

1. Ensure all samples are completed.


2. Verify that all pending results are reviewed or saved.
3. Remove all specimens from the work area.

Step 2: Perform Shutdown Cleaning

1. Select Shutdown from the analyzer menu.


2. Follow on-screen instructions.
3. Allow the analyzer to aspirate cleaner/rinse solution as
required.
4. Do not turn off the power while shutdown cleaning is in
progress.

Step 3: Power Off

1. Wait until the analyzer indicates shutdown is complete.


2. Turn off the main power switch.
3. Clean the exterior surface using approved disinfectant.
4. Dispose of waste according to the laboratory waste
management procedure.

5. Clinical Chemistry Section


5.1 Policies
Only serum is accepted.
Hemolyzed/lipemic samples are grounds for rejection.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
5.2 Procedures

Tests Performed:

Glucose: FBS, RBS, OGTT (75g).


Lipid Profile: Total Cholesterol, Triglycerides, HDL.
Renal Profile: Blood Uric Acid, BUN, Blood Creatinine.
Instructions for Collection:

1. Pre-collection guidelines
 Patient preparation: Adhere to test-specific requirements, such as
fasting. For example, overnight fasting (at least 12 hours) is needed for
tests like glucose and cholesterol.

 Patient identification: Ensure two unique patient identifiers are used to


label the collection tubes.

 Tube selection: Use a serum separator tube (SST), often identified by a


yellow, gold, or "tiger" top or red top when SST is not available for
chemistry analysis.

 Site selection: The median cubital and cephalic veins in the antecubital
fossa are the preferred venipuncture sites.

2. Collection and processing

 Venipuncture technique:

o Apply the tourniquet for no longer than one minute to avoid


falsely elevated levels of analytes like potassium and calcium.

o Clean the site with 70% alcohol and let it air-dry completely
before inserting the needle to prevent hemolysis.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
o Fill the tube to the correct volume to ensure the proper blood-to-
additive ratio.

 Clotting: Allow blood to clot at room temperature for 30–60 minutes.


Do not refrigerate the whole blood, as this can interfere with the
clotting process and cell-analyte stability.

 Centrifugation:

o Centrifuge the clotted blood within two hours of collection to


separate the serum from the cells.

o Follow the tube manufacturer's guidelines for centrifugation


speed and time, typically 1,000–2,000 x g for 10 minutes.

3. Storage and transport


 Short-term storage:

o Temperature: Store separated serum samples at 2–8°C


(refrigerated) for up to 48 hours for most tests.

o Time limit: Some analytes, like amylase, are less stable and
should be tested on the day of collection.

 Long-term storage:

o Freezing: For analysis beyond seven days, freeze the serum at -


20°C or lower.

o Aliquot: To prevent degradation from repeated thawing and


freezing, divide the serum into smaller aliquots before freezing.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
o Ultra-cold: For maximum stability and very long-term storage
(e.g., retrospective studies), store samples at -70°C to -80°C.

 Transport precautions:

o Transport samples in a sealed, leak-proof biohazard bag to the


laboratory.

o Protect light-sensitive analytes, such as bilirubin, by wrapping


the tube in aluminum foil.

o For temperature-sensitive tests, use frozen cold packs during


transport.

4. Avoiding pre-analytical errors


 Hemolysis: Avoid rough handling of the blood tube, such as vigorous
shaking, which can cause red blood cells to rupture and release
intracellular components.

 Proper mixing: If using tubes with additives, invert them gently the
recommended number of times. Serum separator tubes generally need
5 inversions after collection.

 Contamination: Do not use expired tubes. Ensure the collection site is


fully dry after cleaning to prevent alcohol contamination.

 Repeated freeze-thaw cycles: Never repeatedly freeze and thaw a


sample, as this can degrade analytes.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
5.3 Clinical Chemistry Analyzer Procedure
Snibe B240P Fully Automated Chemistry Analyzer SOP

Preparation before Switch ON

1. Empty Waste
2. Refill Distilled Water
3. Refill Wash Liquid ( 3.5L Distilled Water + 0.5L Alkaline Wash )
4. Place the reagent carousel in the machine.
5. DO NOT FORGET TO UNCAP THE REAGENTS.
6. Thaw 1 pc aliquoted control from the freezer

How to prepare Aliquot of Multi Cal and Multi QC?

1. Aspirate 5ml of distilled water and dispense to lyophilized


material.
2. Place the vial on a flat surface and mixed thoroughly by doing
the figures of 8.
3. Aliquot the reconstituted material to 500ul each for calibrator
and at least 300ul each for control.
4. Place the aliquoted material in the freezer.

How to SWITCH ON?

1. Switch on Main Switch


2. Switch on Sub Main Switch
3. Switch on CPU
4. Click Biossays B240 Plus User icon on the desktop
5. input username: snibe
6. input password: snibe

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
Wait for the analyzer to Standby

How to Perform QC?

1. Click QC
2. Click QC Order
3. Tick the Check Box of the Control
4. Add Order
5. Place control material to designated sample position
Normal Control – position 40
6. Click Play icon
7. Click ok to every prompt

How to Check QC Results?

1. Click QC
2. Click QC Result
3. Tick check box of QC Normal
4. Click Monthly QC
5. Click QC Graph
6. Select Assay for example Gluc
7. Tick the QC Name check box
8. Check QC if within range (between +/- 2SD)

How to perform Sample Test?

1. Click Worklist
2. Enter Name on Barcode
3. Select Tests
4. Click Add Order
5. Place Sample to Sample Carousel
6. Make Sure that sample conforms to the position indicated on
the monitor

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
7. Click play

INCASE YOU FORGET TO RUN SPECIFIC TEST

1. Click Worklist
2. Click Specific Sample (Right side corner, Disk No. Po and
Sample No.) make sure it is highlighted in blue
3. Select the test you want to add
4. Click Add Order
5. Click Play

How to Check Results?

1. Click result
2. Click Report

How to Re Run?

1. Click Result
2. Click Expt. Result
3. Check Sample
4. Check Test to Rerun
5. Click Rerun
6. Click play

How to Switch OFF?

1. Click Shutdown
2. Turn Off Computer
3. Switch Off Submain Switch
4. Switch Off Main Switch

CAROUSEL POSITION

W1 ALKALINE
W2 ACID
43 DISTILLED H20

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
42 MULTI CAL
41 HDL/ LIPID CAL
40 NORMAL CONTROL
39 PATHOLOGIC CONTROL
38 HDL LEVEL 1
37 HDL LEVEL 2
36 HDL LEVEL 3

6. Immunology/Serology Section
6.1 Policies

Only DOH/FDA-approved rapid test kits used.


Positive HIV results must be referred to a National Reference Laboratory
(NRL) for confirmation- SACCL- STD/ AIDS COOPERATIVE CENTRAL
LABORATORY.

6.2 Procedures
Tests Performed:
Dengue NS1, IgG, IgM (rapid kit).
Syphilis (Anti-Tp) rapid kit.
HbsAg rapid kit.
HIV screening rapid kit; follow DOH algorithm for referral.

For Rapid Test Kits or Immunochromatographic Assay, refer to the product


insert for instructions for use.

7. Records & Reports

Maintain logbooks for:


• Patient registry
• Specimen log
• Daily QC
• Machine maintenance
Results released only after RMT verification.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP
Retention: Minimum 2 years for results and QC.

Prepared by: Date: Rev. Approved by:


Roda Camay, RMT 6/25/2026 0.0 Emmeline Yu, MD,FPSP

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