SOP

1045 ME Governor’s Drive Oregano St. Brgy.
Maduya, Carmona, Cavite

Tel.No.: 0977-854-7577, (046)430-3456 (Cavite line)
(049)527-4556 (Laguna line), (02)330-4173 (Manila line)
Email add.: occumedica.clinic@yahoo.com
This manual contains the Standard Operating Procedures of
OCCUMEDICA HEALTH CARE SYSTEM CORP.
These Procedures are designed to ensure the accuracy of the test as well as to
preserve the integrity of the laboratory.
BACKGROUND
OCCUMEDICA HEALTH CARE SYSTEM CORP., an institution-based secondary

clinical laboratory, was established on January 12, 2009. The clinic is located
at
1045 ME Governor Drive, Brgy. Maduya, Carmona, Cavite. The clinic ensures
compliance with the RA 4688 or the Clinical Laboratory Act of 1966.
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1045 ME Governor’s Drive Oregano St. Brgy.Maduya, Carmona, Cavite
ADMINISTRATIVE
POLICIES
AND
PROCEDURES
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MISSION
 To produce accurate and reliable laboratory results.
 To give quality and affordable laboratory services to our clients.
VISION
 To provide high-quality, cost-effective, responsive,
comprehensive laboratory services.
 To be the service provider of choice to medical professionals and

patients.
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OBJECTIVES
 To strengthen and enhance the management and
operational/service capacity of the Laboratory Facility for the
provision of efficient and quality services.
 To promote, designed and implemented good laboratory

practices to ensure quality medical laboratory services among
our patients/clients.
 To be compliant to the legislation and regulations in support of

medical laboratory service reform and accreditation of
laboratory facility.
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POLICIES FOR HIRING, ORIENTATION AND

PROMOTION FOR ALL LEVELS OF PERSONNEL
HIRING AND EMPLOYMENT

Section 1: Eligibility Requirements
 Head of the Clinical Laboratory
 A licensed physician certified in Clinical Pathology by the

Philippine Board of Pathology; or
 A licensed physician with three (3) months training on clinical

laboratory medicine, quality control and laboratory management,
may manage a primary/secondary category clinical laboratories.
The BHFS shall certify such training.
 Chief Medical Technologist
 Graduate of Bachelor of Science in Medical Technology;
 Board Certified by the Philippine Regulatory Commission;
 Professional competence in laboratory practice and skill in
 Expertise required using and demonstrating the use of medical

laboratory equipment;
 Broad expertise and expertise in laboratory department operation

and licenses;
 Broad expertise on laboratory procedures and tests;
 Has the capability to correlate results and findings;
 Possess strong leadership abilities, management, people and

organizational expertise.
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 Medical Technologist/Laboratorian
 Graduate of Bachelor of Science in Medical Technology;
 Board Certified by the Philippine Regulatory Commission;
 Good communication and presentation expertise;
 Responsible, mature and can work effectively under pressure;
 Resourceful and well organized;
 Familiar with use of automated equipment and ability to operate

equipment with minimal supervision; as well as
 Perform manual laboratory tests.
As a matter of policy, the clinic will not allow the hiring of immediate
relatives. In principle, these would refer to parents, spouse, brothers, sisters
and children.
Section 2: Duties and Responsibilities of Personnel

A. Head of the Clinical Laboratory:
 Supervise the facilities and all aspects of Clinical Laboratory work;
 Supervise all the Laboratorians;
 Implements the Standard Operation Manual that governs the

Operation of the Clinical Laboratory;
 Supervise and directs all analytical procedures of the Clinical

Laboratory;
 Assures Quality of all Clinical Laboratory Test Results;
 Reads Clinical Pathology slides and provides interpretations;
 Evaluate and recommends reagents, supplies and equipment;
 Reviews the work of Laboratorians especially those of critical

cases;
 Interviews patient for alternative medical explanations, if

necessary;
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 Review rejects and refers for retesting, reconfirmation all

specimen and test results that are questionable;
 Implements remedial actions necessary to maintain satisfactory

operation and performance in the laboratory;
 Directs protocol for preventive maintenance of equipment
 Propose new strategies and additional clinical laboratory

techniques;
 Provides comprehensive, continuing training and education of

personnel related to conduct of a clinical laboratory.
B. Chief Medical Technologist:
 Formulates the department's standard policies and procedures;
 Ensures full compliance on the set SOPs of the department, of the

clinic policies, rules and regulations by the department's staff;
 Prepares all necessary documents for securing or renewing all

necessary licenses/permits to operate a Clinical Laboratory;
 Reviews, coordinates and prepares requests for procurement of

laboratory machines/equipment, supplies and materials;
 Ensures machines/equipment are functional and makes reliable

results at all times;
 Ensures that all supplies are available as required;
 Participates in the selection and training of staff;
 Ensures adequate staffing in the department at all times;
 Supervises and participates in the performance of all standard

clinical laboratory tests and procedures;
 Ensures preparation and submission of required reports;
 Responsible for trouble-shooting when emergency arises in the

department;
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 Keeps herself/himself updated on the latest/recent development,

current literature and sources of information of information in
medical technology appropriate to the field of specialization;
 Recommends and ensures that laboratory staff acquires

appropriate accreditation/trainings/expertise necessary to the
assigned section;
 Represents the Laboratory Department in the monthly

administrative staff meeting and in all other meetings which will
require representation of the department;
 Instills discipline among subordinates; counsels staff when

necessary; implements disciplinary action when needed;
 Performs other tasks as may be assigned from time to time.
 Refers to the Head of the Clinical Laboratory as the need arises.
C. Medical Technologist/Laboratorian:
 In charge with the collection of blood specimen from patients

(Phlebotomist);
 Advises patients on preparations and procedures to be observed

prior to extraction;
 Screens and rejects unsatisfactory specimens received in the

section;
 Performs laboratory procedure and responsible for releasing

precise and accurate results;
 Ensures that standard laboratory methods and techniques are

implemented;
 Responsible in running controls and standards to make sure that

the reagents are still in good condition to produce accurate
results;
 Establishes and interprets quality control charts trends and shifts;
 Monitor and maintains ideal temperature necessary for storage of

reagents and specimens;
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 Ensures that equipment is properly maintained through regular

calibration and preventive maintenance to guarantee quality and
accuracy of results;
 Ensures over-all quality practices in the Pre-examination, Analysis

Examination and Post-examination phase;
 Ensures that stock levels of supplies needed for the operation are
available at all times;
 Facilitates send-out of special examinations;
 In charge of the overall cleanliness and safety in the laboratory;
 Refers to the Head of the Clinical Laboratory as the need arises.
Section 3: Employment Status

a. Probationary Employees – A person who is hired by the clinic for
the purpose of occupying a regular position. Before a
probationary employee can become a regular employee, the
employee is required to undergo a probationary employment
period of a maximum of six (6) months and after meeting the
conditions of Section 3, the status may be elevated to that of a
regular employee.
b. Regular Employees – An employee who, after passing the

probationary period of a maximum of (6) months and meeting the
conditions of Section 3 is elevated to regular status and placed in
the regular payroll of the company and enjoys the benefits and
services extended to the employees subject to guidelines covering
the availment of such benefits and service.
c. Contractual Employee – A person whose employment has been

fixed to a specific project or undertaking the completion or
termination of which has been determined at the time of
employment of the employee.
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Section 4: Regularization
A probationary employee will be elevated to regular status if he/she
meets the following:
a. Employee passes the performance evaluation to be conducted by

the chief/head of the department during the probationary
employment. This evaluation shall cover the attendance and
adherence to the rules and regulations.
b. That the employee passes the physical and health requirements of

the clinic.
Section 5: Personal Data

Employees are required to submit the following documents upon
joining the company:
 Resume with job description and 1 x 1 size picture
 Passport size picture with background
 Transcript of records and diploma
 PRC ID and Certification
 Certificate of training and seminar (if any)
 Previous employer’s certificate/clearance
 Barangay certificate
 Police clearance
 SSS E1 or ID
 Philhealth ID/No.
 TIN No./ID
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Section 6: Promotion
A promotion is defined as an advancement of an employee from one position
to another usually accompanied by an increase in duties and responsibilities
as authorized by law and accompanied by an increase in salary.
The following guidelines are followed in the promotion selection process:
 Promotions are based upon merit;
 Evaluations are job-related and will be done annually;
 Management retains the right to select or not select candidates from any
source it determines is appropriate.
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ORIENTATION GUIDELINES AND CHECKLIST

The following checklist has been designed for use with new staff
members. It is the responsibility of the supervisor to ensure the induction can
take place including arranging the necessary resources and organizing
meetings. It is the responsibility to the new staff member to complete the
checklist. The supervisor will be available to support the new employee to
complete the checklist and answer any questions.
Employee’s Name:_______________________________________________ Start Date: _______________
Position: _______________________________________________________
First day- to be completed with employee
 Clinic policy Overview

 Introduce to the staff
 Tour of premises
 Instruction on entry and exit, including lights
 Use of equipment (photocopier/scanner)
 Use of communications (phone, email, fax, and computer file system)
Employee has received an Induction Pack that includes:
 Employment Contract
 Job /Position Description
First week
 Informed of three (3) month probationary period

 Performance and development review process explained
 Attendance, leave and holidays explained (work hours, etc.)
 Benefits explained
 Pay periods explained
 Clarify position role and responsibilities
 Orient on laboratories procedure or laboratory flow
 Releasing of results
Conducted By: Conformed:
__________________________________ _________________________________
Clinic Supervisor Signature of Employee
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POLICY PROGRAM FOR CONTINUING PROGRAM ON

STAFF DEVELOPMENT AND TRAINING
 The clinic provides a comprehensive, continuing training and

education of personnel related to conduct of drug testing
laboratory.
 Assistance will be given to the staff who will attend

seminars/convention for the promotion and implementation of
quality assurance program of a drug testing laboratory.
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POLICIES FOR DISCIPLINE, SUSPENSION,

DEMOTION AND TERMINATION OF PERSONNEL AT
ALL LEVELS; OFFENSES AND ITS CORRESPONDING
DISCIPLINARY ACTION
TIMECARD
 Any employee who does not find his timecard on the rack should
immediately notify the timekeeper or in his absence, the HRD staff.
 Punching the timecard of another employee or having one’s timecard

punched by another employee or falsifying entry in is penalized as
follows:
1st offense = 3 days suspension
2nd offense = 7 days suspension
3rd offense = Termination
 At the end of each payroll period, all employees should certify to the
accuracy of all entries on their timecards by signing their names on the
space provided at the bottom part of the timecard
 Disfigurement or mutilation of timecard
1st offense = Written warning and 3 days suspension
3rd offense = 7 days suspension
4th offense = 15 days suspension
5th offense = Termination
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TARDINESS
 All employees are expected to report for work on time. Therefore,
tardiness would mean as coming to work past the required time which
the work should start. For purposes of discipline, the company
considers tardiness as an offense if it is committed six (6) times or more
at any given month.
1st offense = Written warning and 3 days suspension
ABSENCES
 The employee is considered absent when he fails to report for work
during his regular working day, or reports one (1) hour beyond his
regular schedule and not allowed to work.
 If because of illness, accident for any reason an employee cannot report

for work, he or his representative must promptly notify the HRD office
as soon as possible within 24 hours so that arrangements, if necessary,
can be made for a temporary replacement. At any rate, the employee or
his representative should file a duly authorized leave form on or before
the scheduled absent to HRD office.
 Unauthorized absences or absence from work without official leave

(AWOL) or without notice, or even if with notice if in the opinion of the
company, the cause for absence is not justified, the penalties are as
follows:
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 AWOL for one (1) day:
1st offense = Verbal warning
2nd offense = Written warning
 AWOL for 2-5 consecutive days:
 AWOL for 6-10 consecutive days:
 AWOL for more than 10 consecutive days
1st offense = Termination
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WORKING HOURS
 The company conforms to labor rulings that no employee shall be
required to work regularly more than eight (8) hours a day, unless
otherwise authorized.
 No employee shall render overtime work and shall not be paid if the
employee is absent the day before the specified overtime and no
employee shall work on regular Sundays and Holidays unless prior to
such overtime work, approval thereto is given by the employee’s
department head. A copy of this overtime request must be furnished to
the HRD office.
 Leaving the clinic premises during working time or clinic hours without
excuse slip duly approved by the supervisor and that of the HRD office:
1st offense = Written warning
PERSONAL PHONE CALLS

 Telephones are strictly limited for business calls. In case of emergencies,
you will receive telephone messages from our receptionist or you can
ask special permission from your supervisor to make urgent outgoing
telephone calls for a fee.
IDENTIFICATION CARD (ID)

 Whenever inside the clinic premises, everyone is expected to wear their
respective ID’s. Any loss or stolen ID’s should be reported once to the
clinic administrator. Unreported loss or stolen ID’s or inappropriately
used ID is the sole responsibility of the owner.
 Failure of any employee to wear or misuse her or others ID while inside

the premises shall be penalized as follows:
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OFFENSES AGAINST PERSON

 INSUBORDINATION OR REFUSAL TO OBEY A COMPANY/CLINIC
ORDER OR WORK ASSIGNMENT
 Any reasonable and justifiable verbal or written order from the

superiors related to work assignment must be promptly obeyed.
Refusal to work on compulsory overtime falls under this rule:
 INTRIGUING AGAINST ANOTHER EMPLOYEE BY ANY MEANS TO

CAST DISHONOR, DISCREDIT OR CONTEMPT, OR PUBLIC HATRED
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PROCEDURES FOR HANDLING OF COMPLAINTS

AND LABORATORY ACCIDENTS
 Any complaints by the clients/patients (written or verbal) should be

given proper attention and be referred to the Clinic Supervisor.
 The Clinic Supervisor evaluates the gravity of the complaints/grievance

made by the clinic staff/personnel.
 Apologize to the client’s base on the complaints made by the clinic staff.
 Based on the evaluation and investigation of the complaints/grievances

made by the clinic staff the Clinic Supervisor must have the equivalent
disciplinary action stated on clinic policy.
 An official meeting will be scheduled to the Medical Director for the

approval or any consideration with regards to the complaints and the
disciplinary action for the said clinic staff.
 All complaints and disciplinary action must be properly documented.
I. For Laboratory Accidents

 Any laboratory accidents such as Specimen rejection, disposal of
specimen not due for disposal and others must be recorded.
 If in case a specimen submitted spills before analysis, a new specimen

from the donor should be collected. This accident must also be
documented.
II. Handling Complaints And Work Ethics

A. Job Performance:
First offense: Written warning
Second offense: Suspension
Third offense: Dismissal

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Criteria:
 Gross inefficiency in the performance of duties.
 Negligence or carelessness in the performance of duties resulting to

loss or damage of the company property.
 Abuse of authority.
B. Decorum and Discipline:
Criteria:
 Discourtesy, rudeness or indifference in dealing with clients, company

officers and staff members.
 Any act of disloyalty in word or deed and/or circulation of malicious

rumors which could discredit or damage the reputation of the company,
its management and staff.
 Trespassing or unauthorized use of company facilities.
 Unauthorized disclosure of confidential information or divulging

company trade secrets.
 Vandalism, willful or malicious destruction or defacement of company

property.
 Unauthorized entry into restricted areas.
 Insubordination or willful refusal of a subordinate to follow proper

orders from his superior in connection with the official performance of
assigned duties and responsibilities.
 Sleeping during working hours.
 Reporting for work drunk or drinking liquor while on duty.
 Prolonged use of the telephone for unofficial business.
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 Acting in a disorderly manner in company premises thereby creating

disturbance as interpreting the normal flow of activities.
 Entertaining guest while on duty for unofficial business.
 Threatening, intimidating or coercing fellow employees in company

premises.
 Making personal gain out of company material on property.
 Commission and/ or conviction of a crime, or commission of a offense

within or outside the company involving damage or turpitudes.
C. Acts of Dishonesty:
Criteria:
 Malversation of company funds.
 Theft of pilferage of property of those belongings to other

personnel.
 Failure to disclosure serious ailment which may endanger the

health of company employee
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TECHNICAL
POLICIES
AND PROCEDURES
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PROGRAM FOR THE PROPER MAINTENANCE AND

MONITORING OF PHYSICAL PLANT AND
FACILITIES
 Scheduled a regular cleaning of the physical plant and facilities

 Practice and Implement the 5’s in Housekeeping
 Practice of waste segregation effectively
 Regular cleaning and sanitized urine collection area and floors.
 Regular cleaning of the air conditioning unit be observed
 Electrical system should be safe and provide appropriate lighting
to the workplace to prevent hazards to the clinic staff
 Light fixtures such as outlets , sockets and switches to avoid the
entry of vermin
 Pest Control must be in a regular scheduled
 Regular cleaning and checking of the storage area
 Wearing of PPE’s is a MUST
 There will be a separate log sheet for the maintenance of
facility/area which will be accomplished daily by the medtech-on-
duty and checked by the Head of the Laboratory every visit.
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PROGRAM FOR CALIBRATION, PREVENTIVE

MAINTENANCE AND REPAIR FOR THE EQUIPMENT
I. Protocols in Preventive Maintenance, Calibration and
Repair for Equipment
 The laboratory should keep an equipment maintenance/calibration
logbook wherein laboratory personnel should input necessary
information for every preventive maintenance action, calibration and
repair. Maintenance of records shall be maintained and checked by the
Head of the Laboratory every visit. Information shall include:
- Type of equipment
- Equipment unique identifier or serial number
- Date of maintenance
- Out of Service Date
- Adjustments or repairs made
- Identity of the personnel who performed the maintenance
 If maintenance is performed by an external vendor/equipment

manufacturer, certificate of calibration must be issued and must be
logged too in the logbook.
 Each laboratory personnel will have a designated responsibility in

performing calibration and preventive maintenance. They will be
provided proper training on usage as well as maintenance of different
laboratory instruments/equipment in accordance with this program.
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II. Procedure for Maintenance of Equipment

I. Maintenance of Microscope
 Daily
a. Optical surfaces
- Use a fine hairbrush to remove dust from all optical

surfaces.
- Remove oil and finger marks immediately from the lenses

with several thickness of lens tissue.
- Do not use any type of tissue other than lens tissue

otherwise you may scratch the lens.
- Use very little pressure to prevent removal of the coatings

of the lenses.
b. Cleaning Solutions
- Use water-based solutions for normal cleaning.
- If you have to use organic solvents, use them in very small

amounts and only if absolutely necessary to remove oil from
the lens.
- Since microscope manufacturers do not agree on solvents to

be used, each company’s recommendations should be
consulted.
- One recommended solvent is 1, 1, 1-trichloroethane; it is

good for removing immersion oil and mounting media and
will not soften the lens sealers and cements.
- Xylene, any alcohols, acetone, or any other ketones should

never be used as cleaning fluids.
c. Lamp
- Make sure that the lamp is cool and the switch is in the off
position when replacing or removing the lamp.
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- To remove oil received from fingers: Clean the lamp after it

has been installed into the lamp holder, with lens tissue
moistened in 70% isopropyl or ethyl alcohol.
d. Stage
- Clean the stage with a small amount of disinfectant (70%

isopropyl or ethyl alcohol) when it becomes contaminated.
e. Condenser
- Using petroleum jelly or light grease, clean and lubricate the

sub-stage condenser slide as needed.
f. Dust Cover
- Cover the microscope when not in use.
- In extremely humid climates (a relative humidity of more

than 50%) good ventilation is necessary to prevent fungal
growth on the optical elements.
II. Maintenance of Centrifuge

 Daily
a. Inspection before each run
- Visually check the carrier cups, trunnions and rotor for

corrosion and cracks.
- If anything is found to be defective, replace it immediately

or remove the equipment from service.
- Check for the presence and insertion of the proper cup

cushions before each run.
- If there is a recorded spillage, disinfect the centrifuge bowl,

buckets, trunnions, and rotor with 10% household bleach or
phenolic solution.
- Following disinfection, rinse the parts with warm water and

perform a final rinse with distilled water.
- Thoroughly dry the parts with a clean absorbent towel to

prevent corrosion.
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III. Maintenance of Refrigerator/Freezer
 Daily
a. Daily records
- On a daily basis, monitor and record the temperature of the

refrigerator.
- On a daily basis, monitor and record the temperature of the

freezer. The thermometer should be placed in anti-freeze to
permit stable temperature recording.
 Periodically
- Monthly, check the door gasket for deterioration, cracks and

proper seal. Seal problems are often seen when ice begins to
build up in a freezer or the temperature is not holding.
Periodically, petroleum jelly can be rubbed onto the door
gasket to lubricate the material and to help maintain
flexibility for a tight seal when the door is shut.
- Semiannually, clean the condenser tubing and air grill with

a vacuum cleaner.
- Semiannually, wash the interior with a warm solution of

baking soda and water. Rinse with clean water, and dry.
Also, wash the door gasket and water collection tray with a
mild soap and water. If the gasket accumulates a black mold,
scrub with 50% household bleach solution and a small
brush. Rinse with clean water and dry.
IV. Maintenance of Autoclaves
 Weekly
- Remove the outlet screen and clean with detergent and a

brush under running water.
- Clean the chamber using a cloth. Do not use abrasive

cleansers or steel wool, as these will scratch the surface and
increase corrosion.
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- Clean the door or lid gaskets with a cloth and check for
defects. Replace defective gaskets.
- Clean the shelves in the autoclave or the basket or cart that

holds packs (including the wheels of the cart) with
detergent and a cloth.
V. Maintenance of Pipettes
 Weekly
- Clean the external parts of the pipette with a soap solution.

In most cases the pipette can also be cleaned with
isopropanol, but check with the manufacturer. Next, remove
the tip ejector to expose the nose cone. Ensure that the tip
ejector contains no debris or residue. Thoroughly clean the
external portion of the nose cone.
- Remove the nose cone, which is usually screwed into the

pipette handle. In most cases this will expose the piston,
seals, and rings. Clean the oriﬁce at the tip of the nose cone
to ensure that it is completely free of debris.
VI. Maintenance of Chemistry Analyzer
 Daily
- Any spill on, or around the instrument should be cleaned

immediately.
- At the end of the day, disconnect the power source by

switching off at the wall socket if applicable and removing
the plug or disconnecting the battery terminals.
- For wet chemistry analyzers: Keep the sample chamber

empty and closed when not in use.
- Cover the instrument after use.
- Store appropriately away from dust.
 Semi-annually
- Inspect the instrument visually to verify the integrity of its

components according to the manufacturer’s specifications.
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- Verify that the buttons or control switches and mechanical

closures are mounted fi rmly and that their labels are clear.
- Ensure that all the accessories are clean and intact.
- Check the adjustment and condition of nuts, bolts and

screws.
- Make sure the electrical connections do not have cracks or

ruptures. Test that they are joined correctly.
- If applicable:
a. Verify that cables securing devices and terminals are

free from dust, grime or corrosion.
b. Verify that cables are not showing signs of splicing or

of being worn out.
c. Examine that the grounding system (internal and

external) is meeting the electric code requirements.
- Make sure the circuit switches, fuse box and indicators are
free from dust, corrosion and grime.
- Check lamp alignment if recommended by the

manufacturer.
 Annually
- Check the installation location for safety of the electrical

(for instruments using main power only) and the physical
infrastructures.
- For instruments using main power:
a. Check that the voltage is appropriate and does not

vary more than 5% from the voltage in the equipment
specifications.
b. Check that the polarity of the outlet is correct.
- Check that there is sufficient space around the instrument

for the connecting cables and for adequate ventilation.
- Test the integrity of the counter and its cleanliness.

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- Verify that the instrument is away from equipment

generating vibrations and direct solar radiation.
- Check that there is no excessive humidity, high temperature

or dust.
- Ensure that there is no source of smoke, gas or corrosive

emissions nearby.
VII. Maintenance of Hematology Analyzer
 Daily
- Before starting Hematology Analyzer, we recommend to

check the reagent levels in each bottle, and the level of the
waste container. Please also check the paper quantity in the
printer.
- Before an analysis, laboratory personnel must properly turn

on and operate start-up rinsing as indicated in the manual.
- At the end of the laboratory operating hours, the laboratory

personnel in charge must ensure proper shutting down of
the hematology analyzer and must clean the cover above
and around the sampling needle with a wet paper with a
disinfectant to eliminate the blood trace.
- At the end of the day, disconnect the power source by

switching off at the wall socket if applicable and removing
the plug or disconnecting the battery terminals.
- Cover the equipment after use.
 Monthly
- Concentrate cleaning is necessary when the hematology

analyzer is in permanent rejection for one measured
parameter. Prepare a Sodium Hypochlorite solution at 12°
in chloride (or 3.6%) (diluted 4 times with distilled water if
sodium hypochlorite is concentrated at 48° in chloride or
three times with 36°). Perform as instructed in the manual.
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 Semi-annually
- Perform piston and needle greasing as instructed in the

manual. Operators must be trained and to know that due to
moving parts there is a risk to pinch their fingers between
pistons and the syringe body.
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SCHEDULE OF PREVENTIVE MAINTENANCE

ACTIONS TO BE SCHEDULE/
NAME OF FACILITY/AREA
DONE FREQUENCY
Stock room Cleaning Weekly
Extraction Area Cleaning Daily
Clinical Working Area Cleaning, Clearing Daily
Client Waiting Area Cleaning Daily
Windows Cleaning Weekly
Pathologist’s Area Cleaning Weekly
Sink Cleaning, Declogging Daily
Laboratory Supplies
Clearing, Dusting Weekly
Cabinets
Countertops Cleaning Daily
Ceiling Dusting Weekly
Tables Cleaning Daily
Chairs Cleaning Weekly
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NAME OF EQUIPMENT/ ACTIONS TO BE SCHEDULE/

INSTRUMENT DONE FREQUENCY
Specimen/Reagent Clearing, Cleaning Twice a month

Refrigerator/Freezer
Maintenance Periodically
Dusting Daily
Clinic System Computer Update/Antivirus
Quarterly
run
Dusting Daily
Printer Inspect for Ink refill/
Twice a month
Head Cleaning
Aircon Unit Cleaning Twice a year
Aircon Filter Cleaning Monthly
Calibration Twice a year

Clinical Centrifuge
Cleaning Daily
Calibration,
Periodically
Chemistry Analyzer Maintenance
Cleaning Daily
Calibration,
Periodically
Hematology Analyzer Maintenance
Cleaning, Start-up Daily
Pipettes Cleaning, Calibration Twice a year
Autoclave Cleaning Weekly
Cleaning Daily
Microscope
Calibration Annually
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CONTINGENCY PLAN IN CASE OF EQUIPMENT

BREAKDOWN
1. Repairing of the worn out equipment must be done by an

authorized technician.
2. The manufacturer/supplier of equipment must provide

service/backup equipment.
3. Referral of examinations (sent-out) outside of the clinical

laboratory should be implemented.
4. Patient will be referred to the other laboratory, Biñan Doctor’s

Hospital, our based hospital.
34 | P a g e
POLICY GUIDELINES ON LABORATORY BIOSAFETY

AND BIOSECURITY
I. Biosafety ƒ
Objective: reduce or eliminate accidental exposure to different hazards
in the workplace
II. Biosecurity ƒ
Objective: provide clinical laboratory personnel with information to
protect themselves from exposure to different diseases while handling and
processing specimens from patients/ clients.
 Personnel will adhere to the guidelines outlined in this policy when

handling and processing specimens from the patients.
 Clinical laboratories performing routine hematology, urinalysis, and

clinical chemistry performing diagnostic tests on serum, blood, or urine
specimens should follow standard laboratory practices.
 Laboratory workers should wear personal protective equipment (PPE),

including disposable gloves and laboratory coats.
 Work surfaces should be decontaminated on completion of work with

appropriate disinfectants.
 Proper waste segregation must be implemented and observed.
 Waste disposal of hazardous/ infectious substances shall be conforming

to the standards set by DOH.
 Storage of any specimen for future testing must be done with the utmost
caution. The specimen should be placed in a disposable rack and the
rack placed into a biohazard bag and the bag sealed. Place the bag in the
appropriate refrigerator or cabinet in such a way as to minimize the risk
of the specimen contamination.
35 | P a g e
Components of Laboratory Biosafety
Engineering Controls
Work Practices
PPE
Biosafety: Work Practices
 Good microbiological technique
 Wash hands often
 No mouth pipetting
 No eating or drinking in lab
 Minimize aerosol generation
 Careful pipetting technique
 Decontaminate work surfaces
 Safe sharps handling
 Training
 Written procedures
36 | P a g e
Biosafety: Personal Protective Equipment
A. Types of PPE
 Gloves
 Appropriate footwear
 Lab coats
 Mask
B. Purpose
 Provides a barrier against skin, mucous membrane or respiratory
exposure to infectious agents.
 To prevent spread of contamination
C. Limitations
 Does not eliminate the hazard
 Integrity wanes with use (change gloves frequently)
 Not all gloves created equal – select best glove for the task
37 | P a g e
GOOD LABORATORY PRACTICE
 Eating, drinking and smoking should not be permitted in any

area where activities might influence product quality or staff
may be exposed to the hazards. There should be designated
areas for eating, drinking and rest personnel
 Pest control is needed, as in the case of storage of papers and

records
 Proper hand washing technique must always be observed by

all the staffs.
 Clinic staffs must practice 5’s in Housekeeping.
 Wear proper PPE’s
 Promotes and Observed Waste Segregation Management
38 | P a g e
PROCEDURE FOR THE PROPER DISPOSAL OF

WASTE AND HAZARDOUS/INFECTIOUS
SUBSTANCES
I. OBJECTIVE
 To establish a procedure in laboratory waste and other pathological

waste disposal thereby ensuring continued improvement in complying
with the environmental system requirements and other applicable
standards. The laboratory must ensure strict implementation of the
procedures through waste minimization and proper identification and
segregation of health care waste in accordance with the Health Care
Waste Management Manual.
II. MATERIALS & EQUIPMENT
 Covered Containers (either Metal or High-density plastic)
 Rigid , puncture proof containers for sharps
 Polyethylene bags
III. HEALTH CARE WASTE IDENTIFICATION AND COLOR CODING

SCHEME
TYPE OF WASTE STORAGE COLLECTION COLLECTION WASTE

AT ON SITE OFF SITE DISPOSAL
SOURCE
Non-infectious Black Garbage Junk shop Recycling

waste dry waste holding area dealer
(Bottles, cans,
papers & cartons)
39 | P a g e
Non-infectious Green Garbage Hog dealer/ • Composting

waste wet waste holding area piggery
• Animal
(Kitchen/dietary owner
feeds
waste)
Infectious waste Yellow Garbage Municipal Landfill

holding area Collector
(Used swabs, gloves
and test tubes)
Sharps waste Red Designated Transfer to Burying

storage area Partner
(Syringes, needles/
hospital
lancets)
ENVIRONMENT & SAFETY REQUIREMENTS
 Handlers must use thick latex gloves in the collection of laboratory

waste
 Handlers must be able to identify the laboratory waste according to the

symbol on the labels placed on the containers. Bags and containers for
infectious waste should be marked with an international infectious
substance symbol.
 Sharps should all be collected together, regardless of whether or not

they are contaminated. Container should be puncture-proof and fitted
with covers.
 Staff should never attempt to correct errors in segregation by removing

items from a bag or container after disposal or by placing one bag inside
another bag of different color. If general and hazardous waste are
accidentally mixed, the mixture should be classified as hazardous health
care waste.
40 | P a g e
WASTE STORAGE ON SITE
 All health care waste should be collected and stored in waste storage
area until transported to a designated off-site treatment facility. This are
should be marked with a marking sign: “CAUTION: BIOHAZARDOUS
WASTE STORAGE AREA - UNAUTHORIZED PERSONS KEEP OUT.”
 Storage areas for health care waste should be located within the
establishment. However, these areas should be located away from the
patients’ rooms, laboratories, hospital function/operation room or any
public areas. The waste in bags or containers should be stored in a
separate area, room or building of a size appropriate to the quantities of
waste produced and the frequency of collection.
WASTE DISPOSAL
Septic Tank
 Free draining blood and blood products may be discharged directly

down the sink and the drain flushed with water.
 Samples of body fluids and testing reagents are discharged directly

down the sink and the drain flushed with water
41 | P a g e
PROTOCOLS / GUIDELINES IN THE OPERATION

AND MAINTENANCE OF THE LABORATORY
 Keep floors free of oil, grease or any other liquid. Clean spilled liquids
immediately because they are slipping hazards.
 Always clean the machine after use and maintain the cleanliness of the
working area.
 Maintain the cleanliness and orderliness of the clinical laboratory.
 Store reagents and other supplies in such a way that there is no direct
sunlight.
 Wastebasket must be placed in logical , convenient locations and

observe segregation of waste materials
 Promptly fix leaky drains or garbage disposal units to prevent entry of

pests.
 Monthly using or spraying of insecticide for the effective control of

pests.
 Disinfection of the laboratory area with 10% bleach or Lysol should be

done before and after laboratory hours daily, especially if there are
specimen spills while working.
LABORATORY EQUIPMENT AND SUPPLIES
1. Proper Care and Maintenance of Glassware and Instruments
a. All general glassware, test tubes, bottles, etc. must be washed

thoroughly with soap and water using a brush to remove
obstinate dirt. Allow to drain and then dry.
b. Slides used should be washed with tap water and then boiled in a
solution of detergent for 30 minutes. Wash thoroughly in tap
water and dry.
42 | P a g e
c. Microscope must be treated with xylene on lens objectives

immediately after use.
2. Laboratory Premises
a. The laboratory must always be kept clean and everything in order

for a smooth working condition.
b. Avoid eating, drinking or smoking inside the laboratory.
c. Avoid unnecessary noise inside the laboratory.
d. Unauthorized persons should not be allowed to stay inside the

laboratory.
3. Laboratory Reagents
a. Proper arrangements and storage of reagents must always be

observed.
b. Flammable solvents, alcohol, ether and xylene should be kept to

the smallest volumes compatible with working needs and should
be kept away from all possible contact with naked flames and
electrical sparks.
c. When diluting acid with water, always add acid to water.
d. Proper handling and labeling of all containers is essential

especially with solutions of poisonous compounds.
43 | P a g e
POLICY ON SECURITY OF SUPPLIES, SPECIMEN AND

CONFIDENTIALITY OF RECORDS
I. Laboratory Safety
The health and safety of individuals working in laboratories is of
paramount importance. The Principal Investigator of a laboratory serves for
that laboratory, and as such has primary responsibility for promoting health
and safety therein. However, all Laboratory Personnel must share that
responsibility. Accordingly, to promote health and safety, and to comply with
applicable regulations governing activities that take place in laboratories, all
Laboratory Personnel must be familiar with the following requirements.
II. Laboratory Security

a. Laboratories contain valuable research equipment, samples, work in
progress, notes and data. They also contain potentially hazardous
materials, such as chemicals, biological agents, and radioactive
substances. All of these assets must be protected from unauthorized
access or removal, theft, or mishandling.
b. All Laboratory Personnel, as well as Employees who access the

laboratories, must take precautions to protect against unauthorized
access or removal, theft, or mishandling of items found in the
laboratories as set forth below. Security measures should
correspond to the potential risks in the specific laboratory.
c. All activities involving the use of laboratory space, materials, or

equipment may only be undertaken with the knowledge and
approval of the responsible Chief Medical Technologist.
d. In order to safeguard laboratories and the data/materials contained

therein, all Laboratory Personnel are, at a minimum, to comply with
the security requirements set forth below.
44 | P a g e
A. Security Requirements
• Limit access to laboratories. Keep laboratory doors closed and

locked unless a qualified clinical laboratory personnel is actually
present.
• Question the presence of unfamiliar/suspicious individuals in

laboratories and/or building common areas. Report all such persons
and/or suspicious activity immediately.
• Report any disruptive individual immediately. Disruptive

individuals may be removed from laboratories per the Employee
Responsibility Policy.
• Normally, laboratory building exterior doors are secured after

designated business hours. To minimize the likelihood of
unauthorized access, all after-hours building users must:
• Avoid providing building access to unfamiliar individuals;
• Secure doors behind themselves; and
• Report any building security issues to the management immediately.
B. Requirements for Securing Documents, Data, Equipment and

Materials
• Secure important research documents, equipment and experimental

materials (e.g., lab notebooks, samples, hazardous substances) in
locked areas.
• Secure devices capable of storing sensitive information or data

(such as computer disks, magnetic tape, flash drives, smartphones,
or tablets) in locked areas.
• Secure access to your computer, and report suspected unauthorized

access.
• Report potentially missing materials, documents, samples, etc.
45 | P a g e
TECHNICAL PROCEDURES OF SERVICES
I. HEMATOLOGY
A. HEMOGLOBIN DETERMINATION (CYANMETHEMOGLOBIN METHOD)
SPECIMEN: Whole blood, using EDTA as the anticoagulant. Capillary blood

may also be used.
PROCEDURE:
i. For each patient and control to be tested, place exactly 5.0 mL of HiCN
reagent into an appropriately labeled test tube. Place 5.0 mL of the
reagent into a test tube to be used as the blank.
ii. Add 0.02 mL of well-mixed whole blood or control blood to the

appropriately labeled tube. Rinse the pipet 3 to 5 times with the HiCN
reagent until all blood is removed from the pipet.
iii. Mix the preceding solutions well and allow to stand at room
temperature for at least 3 minutes to allow adequate time for the
formation of HiCN.
iv. Transfer the mixture to a cuvette and read in a spectrophotometer at a

wavelength of 540 nm using the HiCN reagent in the blank tube to set
the optical density (O.D.) at 0.0. Record the readings for the patient and
control samples from the O.D. scale and refer to the prepared chart for
the actual value of the hemoglobin in g/L
REFERENCE RANGE
NEWBORN: 150-200 g/L
INFANTS (2 months old): 90-140 g/L
ADULT (MALE): 140-160 g/L
ADULT (FEMALE): 120-140 g/L
46 | P a g e
B. HEMATOCRIT DETERMINATION (MICROHEMATOCRIT METHOD)
SPECIMEN: Whole blood using EDTA as the anticoagulant.
PROCEDURE
i. Allow the capillary or well-mixed anticoagulated whole blood to enter

two microhematocrit tubes until they are approximately two-third’s
filled with blood.
ii. Seal one end of the microhematocrit tube with the clay material by
placing the dry end of the tube into the clay in a vertical position. The
plug should be 4 to 6 mm long. Make certain blood is not forced out the
top of the microhematocrit tube during this process.
iii. Place the two microhematocrit tubes in the radial grooves of the
centrifuge head exactly opposite each other, with the sealed end away
from the center of the centrifuge.
iv. Centrifuge for 5 minutes.
v. Remove the hematocrit tubes as soon as the centrifuge has stopped

spinning. Determine the results for both microhematocrits, using the
microhematocrit tube reading device. Duplicate results should agree
within 1 unit (%). If they do not, repeat the procedure.
REFERENCE RANGE
NEWBORN: 0.45-0.60 (45-60%)
CHILDREN (1 y.o.): 0.27-0.44 (27-44%)
ADULT (MALE): 0.40-0.54 (40-54%)
ADULT (FEMALE): 0.36-0.46 (36-46%)
47 | P a g e
C. MANUAL WHITE BLOOD CELL COUNT

may also be used.
PROCEDURE
i. Dilution of blood. Mix the specimen of whole blood for approximately 1

minute. Proceed with testing according to the blood dilutions on each
specimen to be tested.
ii. Draw the blood up to the 0.5 mark in the Thoma pipet.
iii. Remove the blood from the outside of the pipet with clean gauze.
iv. Holding the pipet almost vertical, place the tip into the fluid. Draw the
diluting fluid into the pipet slowly, until the mixture reaches the 11
mark, while gently rotating the pipet to ensure a proper amount of
mixing.
v. Place the pipet in a horizontal position and firmly hold the index finger
of either hand over the opening in the tip of the pipet. Detach the
aspirator from the other end of the pipet.
vi. The dilution of blood is now complete. The white cell pipet is divided
into units or volumes: 0.5, 1.0, and 11. The stem contains 1.0 unit and
the bulb holds 10 units. The blood is drawn up into the pipet first. As the
diluting fluid is aspirated, all of the blood is drawn up into the bulb.
Therefore, if the blood is drawn up to the 0.5 mark and diluted to the 11
mark, there is 0.5 volume of blood and 9.5 volumes of diluting fluid in
the bulb of the pipet, for a total of 10 volumes. The stem contains the
last 1.0 volume of diluting fluid and contains no blood. The dilution of
blood is, therefore, 0.5 in 10 or, 1:20.
vii. Clean the counting chamber and cover glass with a lint free cloth.
Carefully place the cover glass on top of the ruled area of the counting
chamber.
viii. Mix the Thoma pipet for approximately 3 minutes to ensure hemolysis
of the red blood cells and adequate mixing.
ix. Hold the pipet in a vertical position with the right index finger covering
the top of the pipet. Discard the first four drops of the mixture onto a
48 | P a g e
piece of gauze. Remove any excess liquid from the outside of the pipet
with a piece of gauze.
x. Place the tip of the pipet on the edge of the ruled area of the counting
chamber. Allow the mixture to seep under the coverglass gradually and
exactly fill this area.
xi. Fill the opposite side of the counting chamber with the second white
count dilution.
xii. When the counting chamber is filled, care should be taken that it is not
jarred or the cover glass moved. The filled counting chamber should be
allowed to stand for approximately 1 minute prior to performing the
count to give the WBCs time to settle.
xiii. Carefully, keeping the counting chamber horizontal at all times, place
the hemocytometer on the stage of the microscope.
xiv. Using the low power (10x) objective, make certain the microscope light
is adjusted correctly. In proper focus, the WBCs should look like small
dark or black dots.
xv. Scan the four large corner squares marked ‘W’. For accurate white
counts, there should be an even distribution of cells in all four large
squares, with no more than a ten-cell variation between the four
squares.
xvi. Beginning with the upper left square, count all WBCs in the four large
corner squares and add the results together to obtain the total number
of cells. In counting the cells that touch the outside lines of the large
square, count only those that touch the left (or right) and upper (or
lower) outside lines (in counting chambers with double lines),
disregarding those that touch the right (or left) and lower (or upper)
outside margin. If the chamber has triple lines, count those cells that
touch the middle of the three outside lines on two sides and disregard
those touching the corresponding lines on the other two sides.
xvii. Count the cells on the opposite side of the counting chamber and record
the number of cells counted in these four large squares. The total
number of cells counted on each side of the counting chamber should
agree within 10% of each other. If the counts do not agree, the
procedure should be repeated.
49 | P a g e
xviii. For each of the two white counts performed, calculate the number of
WBCs/uL, as shown below:
a. WBC count = # of WBCs counted x Area correction factor x

Dilution factor
xix. Calculate the WBC for the second white count and average the two
numbers for the final result.
REFERENCE RANGE
NEWBORN: 10.0 – 30.0 x 109/L ( 10,000 – 30,000 x 106/L)
CHILDREN (1 y.o.): 6.0 – 17.0 x 109/L (6,000 – 17,000 x 106/L)
ADULTS: 5.0 – 10.0 x 109/L (5,000 – 10,000 x 106/L)
50 | P a g e
D. MANUAL RED BLOOD CELL COUNT
SPECIMEN: Whole blood, using EDTA or heparin as the anticoagulant.

Capillary blood may also be used.
PROCEDURE
i. Draw the blood up to exactly the 0.5 mark in the Thoma red count pipet
and dilute to the 101 mark with red count diluting fluid, thus making a
1:200 dilution of blood.
ii. Clean the counting chamber.
iii. Mix the diluted RBC counts for 3 minutes.
iv. Fill the counting chamber. Once the counting chamber is filled, allow
approximately 3 minutes for the RBCs to settle prior to counting.
v. Carefully place the filled counting chamber on the microscope stage.
vi. Using low power (10x) objective, place the large center square in the
middle of the field of vision. Examine the entire large square for even
distribution of RBCs.
vii. Carefully change to the high power objective (40x).
viii. Move the counting chamber so that the small upper left corner square is
completely in the field of vision. The square is further subdivided into
16 even smaller squares for ease of counting.
ix. Count all RBCs in this square, remembering to count the cells on two of
the outer margins but excluding those lying on the other two outside
edges.
x. Some of the RBCs may be lying on their sides and, therefore, do not
appear as round. These cells are to be included in the count.
xi. If there are any WBCs in the area being counted, do not include these
cells in your count.
xii. Count the RBCs in each of the five small squares.
xiii. Count the RBCs on the opposite side of the counting chamber in the
corresponding five small squares.
51 | P a g e
xiv. Calculate the RBC count for each of the red counts performed and
average the two results for the final report.
RBC count = # cells in 5 squares x Area correction factor x Dilution factor x

106
REFERENCE RANGE
NEWBORN: 5.0 – 6.5 x 1012/L
CHILDREN (1 y.o.): 3.5 – 5.1 x 1012/L
ADULT (MALE): 4.0 – 5.6 x 1012/L
ADULT (FEMALE): 4.0 – 5.0 x 1012/L
52 | P a g e
E. DIFFERENTIAL CELL COUNT

may also be used.
PROCEDURE
i. Check the blood smear to ensure that it is well made. The tail of the film
should be smooth. Place the slide on the microscope stage.
ii. Examine the blood smear using the low power (10x) objective.
iii. The RBCs, WBCs and platelets must be correctly stained.
iv. Check that there is even distribution of the WBCs on the smear.
v. Estimate the WBC count. It should agree with the test result obtained. If
it does not, the white count should be repeated.
vi. Examine the thin peripheral edge of the smear. If there is an increased
number of WBCs in this area, the differential cell count may be
inaccurate. If there are clumps of platelets, the body of the smear may
then show a decrease in platelets. In such situations, the blood smear
should be discarded and another made.
vii. When scanning the blood smear, it is important to note anything

unusual or irregular, such as large, abnormal looking cells or rouleaux
formation of the RBCs.
viii. Choose the area of the blood smear where the differential counting is to
begin, place a drop of oil on the slide and carefully change to the oil
immersion objective (100x).
ix. Perform the differential count and, at the same time, examine the
morphology of the WBCs.
x. Identify each WBC seen and record on a differential cell counter until
100 WBCs have been counted.
xi. Examine the RBC morphology in a thin area of the slide where only a
few of the RBCs slightly overlap.
xii. Examine the platelets on the smear for morphology and number
present. Using the same fields on various parts of the smear, determine
the approximate no. of platelets per field.
53 | P a g e
REFERENCE RANGE Relative Count Absolute Count
NEUTROPHILS: 40 – 60% 2.0 – 6.0 x 109/L
LYMPHOCYTES: 20 – 40% 1.0 – 2.0 x 109/L
MONOCYTES: 1 – 8% 0.1 – 0.8 x 109/L
EOSINOPHILS: 0 – 4% 0.0 – 0.4 x 109/L
BASOPHILS: 0 – 2% 0.0 – 0.2 x 109/L
54 | P a g e
F. ERYTHROCYTE SEDIMENTATION RATE (WESTERGREN METHOD)
SPECIMEN: Anticoagulated blood (0.4 ml of 3.13% trisodium citrate solution

+ 1.6 ml blood)
PROCEDURE:
i. Mix the anticoagulated blood thoroughly.

ii. Draw the blood into the tube up to 0 mark with the help of rubber bulb.
iii. Wipe out blood from bottom of the tube with cotton.
iv. Set the tube upright in stand. Make sure the pipette fits snugly to
eliminate possible leakage and that the pipette is in vertical position.
v. Leave the tube undisturbed for 1 hour.
vi. At the end of 1 hour, read the result.
REFERENCE RANGE
ADULT(male): 0-10mm/hr
ADULT(female): 0-15 mm/hr
55 | P a g e
G. BLEEDING TIME (DUKE METHOD)
MATERIALS NEEDED:
• Lancet
• Alcohol Swab
• Cotton
• Filter Paper
• Stop watch/ Timer
PROCEDURE
i. Clean the tip of a finger with alcohol and let dry.

ii. Pierce the tip of a finger with the lancet making the incision 3mm deep
start the stopwatch.
iii. Blot the blood with the filter paper at regular 30 second intervals; move
the filter paper so that each drop touches a clean area do not touch the
incision with the filter paper.
iv. When the filter paper no longer shows sign of blood, stop the timer and
record the time.
REFERENCE RANGE
ADULT: 1-5mins (60secs-300secs)
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H. CLOTTING TIME
MATERIALS NEEDED:
• Lancet
• Alcohol Swab
• Cotton
• Slide
• Stop watch/ Timer
PROCEDURE
i. Clean the tip of the finger with an alcohol.

ii. Prick the finger with an automatic lancet.
iii. Note the time when the blood first appears on the skin.
iv. Place 2 drops of blood in the slide.
v. Mix blood every 30 secs. using the lancet.
vi. When blood forms a continuous thread-like clot the coagulation or
clotting time should be noted.
57 | P a g e
I. MALARIAL SMEAR
SPECIMEN: Anticoagulated blood (using EDTA)
PROCEDURE
i. Place a larger drop of blood in the side of the pre-cleaned, labeled slide.
A thick smear of proper density is one which, if placed (wet) over
newsprint, allows you to barely read the words.
ii. Place a small drop of blood on the pre-cleaned, labeled slide, near its
frosted end.
iii. Bring another slide at a 30-45° angle up to the drop, allowing the drop
to spread along the contact line of the 2 slides.
iv. Quickly push the upper (spreader) slide toward the unfrosted end of the
lower slide.
v. Make sure that the smears have a good feathered edge. This is achieved
by using the correct amount of blood and spreading technique.
vi. Allow the thin smears to dry.
vii. Fix the thin smear by dipping it in absolute methanol, then stain using
Wright stain method.
58 | P a g e
J. BLOOD TYPING PROCEDURE (ABO AND RH)

PROCEDURE
i. Set the table with all the materials required. Remember to place the
Monoclonal Antibody (Mab) kit in an ice tray.
ii. Open an Alcohol swab, and rub it at the area from where the blood will
be sampled. Discard the swab.
iii. Open the lancet cover; put pressure at the tip of the finger from where
blood will be sampled. Prick the fingertip with the opened Lancet.
Discard the lancet.
iv. As blood starts oozing out, make 1 drop fall on the three depressions of
the glass slide.
v. Place a cotton ball at the site where it was pricked, using the thumb put
pressure on the area to stop blood flow.
vi. Take the Anti-A (blue) bottle, resuspend the content and use the
dropper to place a drop of the Mab in the 1st spot. Place the bottle back
in ice.
vii. Take the Anti-B (yellow) bottle, resuspend the content and use the
dropper to place a drop of the Mab in the 2nd spot. Place the bottle back
in ice.
viii. Take the Anti-D (colorless) bottle, resuspend the content and use the
dropper to place a drop of the Mab in the 3rd spot. Place the bottle back
in ice.
ix. Take a tooth pick and mix the content in each well. Discard the tooth
pick after using in one well (take a new one for the next well).
x. After mixing, wait for a while to observe the result.
INTERPRETATION OF RESULTS
 Group A: If there is agglutination observed with anti-A antisera but no
agglutination with anti-B antisera.
 Group B: If there is agglutination observed with anti-B antisera but no
agglutination with anti-A antisera
 Group AB: If there is agglutination observed with both anti-A and anti-B
antisera.
 Group O: If there is no agglutination observed with both anti-A and anti-
B antisera.
 Group D (Rh)-positive: If there is agglutination observed with anti-D
(Rh) antisera.
 Group D (Rh)-negative: If there is no agglutination observed with anti-D
(Rh) antisera.
59 | P a g e
II. CLINICAL CHEMISTRY

A. GLUCOSE DETERMINATION (GLUCOSE OXIDASE METHOD)
PRIMARY SAMPLE COLLECTION, HANDLING AND STORAGE
1. The patient should undergo 8-10 hours of fasting before blood

extraction.
2. Serum: Use non-hemolyzed serum. Plasma: Use heparin
3. Storage: In separated, non-hemolyzed serum or plasma, glucose is

stable for up to 72 hours at 4OC or as long as 8 hours at 25OC. In the
presence of sodium fluoride, glucose is stabilized for as long as 3 days at
room temperature. For long term storage samples should be placed in
sealed containers and frozen at -10OC.
PROCEDURE
Determination conditions:
Temperature 37OC Reagent volume 750 uL
Wavelength 500 nm Sample volume 5 uL
Reaction Time 10 mins Cuvette 1.0 cm
Blank Sample
Reagent (uL) 750 750
Incubate 5 mins at 37OC
Water (uL) 5
Sample (uL) 5
Mix thoroughly and incubate the tube for 10 mins at 37OC. Measure the
absorbance of against the Blank.
REFERENCE RANGE:
4.1mmol/L – 6.4 mmol/L (74 mg/dL – 115 mg/dL)
60 | P a g e
B. BLOOD UREA NITROGEN [BUN] DETERMINATION (KINETIC/UREASE

METHOD)
1. Serum: use non-hemolyzed serum.
2. Storage: BUN in serum is stable for 3 days when stored between 2OC –
8OC.
PROCEDURE
Delay Time 1 min Reaction time 2 mins
Cuvette 1.0 cm
Blank Sample
Water (uL) 6
Sample (uL) 6
Mix thoroughly and incubate the tube at 37OC. Read the absorbance A1
at 1 min. Read the absorbance A2 again after 2 mins.
REFERENCE RANGE
2.5 mmol/L – 6.3 mmol/L (15 mg/dL – 38 mg/dL)
61 | P a g e
C. CREATININE DETERMINATION (KINETIC/ALKALINE PICRATE

METHOD)
1. Serum: use non-hemolyzed serum.

2. Storage: Creatinine in serum is stable for 3 days when stored between
2OC – 8OC.
PROCEDURE
Reaction Time 1 min Cuvette 1.0 cm
Blank Sample
600 (300 uL R1 + 300 600 (300 uL R1 + 300 uL
Reagent (uL)
uL R2) R2)
Water (uL) 60
Sample (uL) 60
Mix thoroughly and incubate the tube at 37OC. Read the absorbance A1
at 30 seconds. Read the absorbance A2 again after 60 seconds.
REFERENCE RANGE
MALE: 60 umol/L – 120 umol/L (0.68 mg/dL – 1.36 mg/dL)
FEMALE: 50 umol/L – 105 umol/L (0.57 mg/dL – 1.19 mg/dL)
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D. URIC ACID DETERMINATION (URICASE METHOD)

extraction.
2. Serum: Use non-hemolyzed serum.
3. Storage: Uric acid in serum is stable for 3 days when stored at 20 OC –

25OC or 6 months when stored at -20OC
PROCEDURE
Blank Sample
R1 (uL) 480 480
Water (uL) 15
Sample (uL) 5
R2 (uL) 120 120
absorbance of the standard and sample at 520 nm against the Blank.
REFERENCE RANGE:
4.1 mmol/L – 6.4 mmol/L (74 mg/dL – 115 mg/dL)
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E. CHOLESTEROL DETERMINATION (CHOLESTEROL OXIDASE METHOD)

extraction.
2. Serum: Use non-hemolyzed serum. Plasma: Use heparin. Do not use

EDTA, Oxalate or Fluoride.
3. Storage: Cholesterol in serum is stable for 7 days at 2OC – 8OC or one

month when stored at -25OC.
PROCEDURE
Blank Sample
Water (uL) 6
Sample (uL) 6
absorbance of against the Blank.
REFERENCE RANGE:
Less than 200 mg/dL (<5.17 mmol/L)
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F. TRIGLYCERIDE DETERMINATION (GK, GPO TRINDER METHOD)

extraction.

3. Storage: Triglycerides in serum is stable for 7 days at room temperature

or one month when stored between 2OC – 8OC. In freezing, sample can
be stable for a longer time.
PROCEDURE
Reaction Time 5-10 mins Cuvette 1.0 cm
Blank Sample
Water (uL) 6
Sample (uL) 6
Mix thoroughly and incubate the tube for 5-10 mins at 37OC. Measure
the absorbance of against the Blank.
REFERENCE RANGE:
Less than 150 mg/dL (<1.69 mmol/L)
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G. HIGH-DENSITY LIPOPROTEINS (HDL)
PRIMARY SPECIMEN COLLECTION AND HANDLING

extraction.

3. Storage: HDL in serum is stable for 7 days at 4-8OC or one month when
stored between -20OC.
ASSAY PROCEDURE
1. PRECIPITATION
Precipitation of LDL, VLDL and Chylomicrons.
Pipette Volumes
Sample or Calibrator 250 μl
Precipitating Reagent 500 μl
Mix well and allow the reaction mixture to stand for 10 minutes at room
temperature, Centrifuge at 4000 rpm (1800xg) for 10 minutes to obtain a
clear supernatant. Use the supernatant to determine the concentration of HDL
cholesterol in the sample.
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2. CHOLESTEROL DETERMINATION
Wavelength: 500 (546) nm
Cuvette: 1 cm
Pipette into tubes marked Blank Calibrator Test
Cholesterol Working Reagent 1000 µl 1000 µl 1000 µl
Distilled water 50 µl – –
Calibrator – 50 µl –
Supernatent – – 50 µl
Mix well, incubate for 10 min. at 37 °C, or 12 min. at 30 °C. Read the
absorbance of the Calibrator and each test at 500 (546) nm or 505/670 nm
for bichromatic analysers against reagent blank.
CALCULATIONS
HDL CHOLESTEROL = Abs. of Test x Concentration of Calibrator

(mg/dl) Abs. of Cal. (mg/dl)
REFERENCE RANGE:
ADULTS (MALE): 35.3–79.5 mg/dl
ADULTS (FEMALE): 42.0–88.0 mg/dl
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H. LOW DENSITY LIPOPROTEINS (LDL)


extraction.
3. Plasma: Use heparin. Do not use EDTA, Oxalate or Fluoride.
4. Storage: HDL in serum is stable for 7 days at 4-8OC or one month when
stored between -20OC.
PROCEDURE
Wavelength: 600/700 nm
Cuvette: 1 cm
Temperature: 37 °C
Serum/reaction mixture ratio: 1/121
Reagents and sample volume can be modified, by respecting reagents/sample

volume ratio.
Reagent blank Calibrator Sample
Reagent R1 0.900 ml 0.900 ml 0.900 ml
Sample - - 0.010 ml
Calibrator - 0.010 ml -
Distilled water 0.010 ml - -
Mix and incubate 5 min. at 37 °C. Measure absorbance A1 of the sample

(Asam), calibrator(Acal) and blank (Abl).Then add:
Reagent R2 0.300 ml 0.300 ml 0.300 ml
Mix and incubate 5 min. at 37 °C. Measure absorbance A2 of the sample (Asam),
calibrator (Acal) and blank (Abl).
Calculate absorbance change ΔA = A2 – A1 for sample, calibrator and blank.
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CALCULATION
LDL Cholesterol (mmol/l) = Δ Asam- Δ Abl

x Ccal
Δ Acal - Δ Abl
Ccal= calibrator concentration
REFERENCE RANGE:
fS LDL cholesterol (mmol/l): < 3.4
Medium risk: 3.4 – 4.1
High risk: > 4.1
*For the determination of LDL cholesterol it is recommended to use serum or

plasma with blood elements removed within 3 hours after collection.
*If concentration of LDL cholesterol exceeds 10.4 mmol/l, dilute the sample
with a saline in ration 1 + 1 and results multiply with dilution factor.
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I. ALANINE AMINO-TRANSFERASE (ALT/GPT)
3. Storage: Loss of activity: within 3 days at 2–8 °C < 10 %; within 3 days

at 15–25 °C < 17 %; Stability at least 3 months at -20 °C.
PROCEDURE
Wavelength: 340 nm, Hg 334 nm, Hg 365 nm
Cuvette: 1 cm
Two reagents method – substrate start
Reagent 1 (buffer) 0.800 ml
Sample 0.100 ml
Mix and incubate for 5 min. at 37°C. Then add:
Reagent 2 (substrate) 0.200 ml
Mix, incubate 1 min. at 37°C and then measure the initial absorbance of
calibrator and sample against reagent blank. Measure the absorbance change
exactly after 1, 2 and 3 min. Calculate 1 minute absorbance change (ΔA/min).
CALCULATIONS
ALT/GPT (U/l) = ΔAsam/min

x Ccal
ΔAcal/min
Ccal = calibrator concentration
REFERENCE RANGE:
ADULT (MALE): 45U/I
ADULT (FEMALE): 34U/I
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J. AST/GOT
3. Storage: Loss of activity: within 3 days at 2–8 °C < 8 %; within 3 days at

15–25 °C < 10 %; Stability at least 3 months at -20 °C.
PROCEDURE
Wavelength 340 nm, Hg 334 nm, Hg 365 nm
Cuvette 1 cm
Two reagents method – substrate start
Reagent 1 (buffer) 0.800 ml
Sample 0.100 ml
Mix and incubate for 5 min. at 37°C. Then add:
Reagent 2 0.200 ml
(substrate)
Mix, incubate 1 min. at 37°C and then measure the initial absorbance of
calibrator and sample against reagent blank. Measure the absorbance
change exactly after 1, 2 and 3 min. Calculate 1 minute absorbance change
(ΔA/min).
CALCULATION
ST/GOT (U/l) = Ccal x ΔAsam/min
ΔAcal/min
REFERENCE RANGE:
ADULT (MALE): 35U/I
ADULT (FEMALE): 31U/I
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K. PERCENTAGE OF HEMOGLOBIN A1C (HBA1C %) (FULLY AUTOMATED

BORONATE AFFINITY ASSAY TEST)
SPECIMEN:
Blood Sample - The capillary blood taken from a fingertip or venous blood
collected in a tube with K2 or K3 EDTA, lithium heparin, sodium citrate or
sodium fluoride/ oxalate as anticoagulants can be used for the CLOVER A 1c®
Self-test.
PROCEDURE:
1. When the power is connected, the display shows 'Warming Up' until the
device is ready for test. Warming up will take approximately 5 minutes
depending on the ambient temperature.
While warming, the CLOVER A 1c® Self Analyzer performs hardware

functionality test to verify that the internal optics and the mechanical
system are operating correctly.
IMPORTANT: Do not move the analyzer during 'Warming up'.
2. When 'Open the lid' is shown in stand-by mode, open the lid.
IMPORTANT: Regarding details on analyzer functionality please refer to

the analyzer instruction for use.
3. Tear the pouch open on the side with serrated edge. Do not use scissors
to open the pouch. Scissors may damage the reagent pack or cartridge.
Use the test cartridge within 2 minutes after opening the pouch.
CAUTION: Do not touch the cartridge code area on the front or bead
window at the back. Any contamination of these area may cause
erroneous results.
4. Gently insert the cartridge into the cartridge compartment when 'Insert
Test Cartridge' is shown. Hold the cartridge with barcode facing left.
Ensure a gentle snap is either heard or felt to confirm proper placement.
NOTE: Do not force the cartridge into the analyzer. It can only be placed
in one way to fit. Environmental influences (e.g. air humidity and light)
can damage the test cartridges and lead to false measurements or error
messages.
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5. The display will show the 'Apply sample to sample area' and 'Insert
Reagent Pack'.
i. Gently mix the reagent pack 5 - 6 times before applying blood

sample.
CAUTION: Do not mix it too vigorously to avoid air bubbles. If air

bubbles appear, wait until they disappear before testing.
ii. Apply the blood sample at the sampling area by carefully touching
the blood drop. Ensure the sampling area is completely filled.
Once the reagent pack is filled with the blood sample, analysis
must begin immediately.
IMPORTANT: Once the reagent pack is filled with the blood

sample, analysis must begin immediately.
6. Use gloves. Dispose of used test cartridges in a sturdy container with lid.
Consult local environmental authorities for proper disinfection
procedures as well as disposal of consumables. Insert the reagent pack
into the cartridge compartment of the analyzer. The 'Close the lid' is
shown.
NOTE: Do not force the reagent pack into the cartridge. It can only be
placed in one way to fit.
7. The test starts automatically when the lid is closed.
IMPORTANT: Do not open the lid during testing. Do not move the
analyzer during testing. Do not expose the analyzer to vibration during
testing.
8. The measuring time is 5minutes and the test result will be displayed (in
% or mmol/mol) .
9. After the test is completed, open the analyzer lid. 'Remove cartridge'
will be shown. Remove the test cartridge from the analyzer by gently
pushing it to the left and pulling it out.
CAUTION: Do not force the cartridge from the analyzer. Dispose all
waste in accordance with applicable national and/or local regulation.
REFERENCE RANGE: <7% HbA1c
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III. SEROLOGY
A. HEPATITIS B SCREENING (HbsAg) (QUALITATIVE) (ONE STEP HBSAG

TEST STRIP)
SPECIMEN COLLECTION
1. Serum or plasma may be used in this test. Anticoagulants typically used

for blood collection do not interfere with this test.
2. Remove the serum or plasma from the clot or red cells as soon as
possible to avoid hemolysis.
3. Hemolyzed, extremely thickened or fatty specimens are NOT suitable

for this assay. Specimens containing particulate matter may give
inconsistent results and should be clarified prior to testing.
4. Serum or plasma specimens should be refrigerated at 2OC – 8OC up to 3

days and frozen at -20OC for longer periods.
5. Shipped specimens should be packed in compliance with federal and

international regulations covering the transportation of etiologic agents.
6. Avoid frequent (more than 3 times) thaw-and-freeze of specimens.
PROCEDURE
i. Bring all reagents and specimens to room temperature.
ii. Remove the test strip from the foil pouch and place on a clean dry
surface.
iii. Identify the test strip for each specimen or control.
iv. Apply at least 80 uL of specimen to the sample behind the arrow mark
at the bottom of test strip.
v. Interpret test results at 15 minutes.
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 NEGATIVE: Only one purplish red test band appears in the control
region.
 POSITIVE: In addition to the control purplish red test band, a distinct

purplish red test band also appears in the test region.
 INVALID: Neither test band nor control band appears. The specimen
should be tested again using a new test card.
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B. HAV IgM test (Immunoassay rapid test)
SPECIMEN:
For serum, collect blood into a container without anticoagulant. Allow

the blood to clot and separate the serum from the clot. For plasma,
collect whole blood into a purple, blue or green top collection tube
(containing EDTA, citrate or heparin, respectively) by vein puncture,
separate plasma from whole blood. Use the specimen inside an hour. If the
specimen cannot be tested inside an hour, store the specimen in 4°C cold
closet or refrigerator, but don't freeze. Bring the specimens to room
temperature before testing. Do not freeze and thaw the specimen
repeatedly.
PROCEDURE:
Dilute the serum (or plasma) specimen with 0.9 % NaCl Isotonic solution
(1:1000 ).
Open a pouch containing a cassette, remove the test kit from the pouch and
place it horizontally on the desk.
Pipette 2 or 3 drops of diluted specimen into the sample well of the

cassette.
Read results within 10-15 minutes. Do not read results after 20 minutes.
Interpretation of Results
 NEGATIVE: Only one pink band appears on test region of the Cassette.
This indicates that there is no detectable HAV antibody in the serum.
 POSITIVE: Two pink bands appear on test region of the Cassette. This
indicates that the specimen contains detectable amount of HAV
antibody.
 INVALID: If without colored bands appear on test region, this is an

indication of a possible error in performing the test. The test used be
repeated using a new device.
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C. hCG Pregnancy Test (Rapid Chromatographic Immunoassay

Qualitative Test)
SPECIMEN:
A urine specimen must be collected in a clean and dry container. A first

morning urine specimen is preferred since it generally contains the highest
concentration of hCG; however, urine specimens collected at any time of the
day may be used. Urine specimens exhibiting visible precipitates should be
centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
PROCEDURE:
1. Bring the pouch to room temperature (15-30℃ before opening it.

Remove the cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface. Hold the dropper
vertically and transfer 2 full drops of urine (approximately 50ul) to
the specimen well of the cassette, and then start the timer. Avoid
trapping air bubbles in the specimen well. See illustration below.
3. Wait for the colored line(s) to appear. The result should be read at 3
minutes.
NOTE: A low hCG concentration might result in a weak line

appearing in the test line region (T) after an extended period of
time; therefore, do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS:
(Please refer to the illustration above)
 POSITIVE: Two distinct colored lines appear. One line should be in the
control line region (C) and another line should be in the test line region
(T). One line may be lighter than the other; they do not have to match.
This means that you are probably pregnant.
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 NEGATIVE: One colored line appears in the control line region (C). No
line appears in the test line region (T). This means that you are probably
not pregnant.
 INVALID: The result is invalid if no colored line appears in the control

line region (C), even if a line appears in the test line region (T). You
should repeat the test with a new test cassette.
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D. ANTI-HBs SCREENING TEST (ONE STEP STRIP STYLE ANTI-HBs TEST)
SPECIMEN:
Use non-hemolyzed serum.
PROCEDURE:
i. Using a serum sample, dip the test strip with arrowside pointing down
into the vessel of serum for about 10 seconds.
ii. Do not immerse past the marker line.
iii. Wait for 10 minutes and read results.
iv. Do not read results after 30 minutes.
 NEGATIVE: Only one colored band appears on the control region. No

apparent band on the test region.
 POSITIVE: In addition to a pink colored band, a distinct pink colored

band will also appear in the test region.
 INVALID: A total absence of color in both regions is an indication of

procedure error and/or the test reagent has been deteriorated.
STORAGE AND STABILITY
The test kit can be stored at room temperature (18OC to 30OC) in the sealed
pouch to the date of expiration. The test kit should be kept away from direct
sunlight, moisture and heat.
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IV. CLINICAL MICROSCOPY
A. ROUTINE URINALYSIS
SPECIMEN:
At least 5ml of midstream urine.
PROCEDURE:
i. MACROSCOPIC EXAMINATION OF URINE
a. Upon receiving the specimen with its corresponding request form, mix
and transfer 10 to 12 mL of urine specimen in a properly labeled test
tube.
b. Note the color and clarity of the urine specimen.
REPORTING
 COLOR: Straw, Light Yellow, Yellow, Dark Yellow, Amber, Orange, Red,
etc.
 CLARITY: Clear, Slightly Hazy, Hazy, Slightly Cloudy, Cloudy, Slightly

Turbid, Turbid, Milky
ii. CHEMICAL EXAMINATION OF URINE
REAGENT STRIP
a. Dip a reagent strip into the urine specimen
b. Wait for the color reaction. Follow the specified time indicated on the
reagent strip container.
c. Compare the result of the strip with the chart printed at the back of the
reagent strip container
d. Record the results for pH, specific gravity (S.G.), protein and glucose
REPORTING
 GLUCOSE (30 secs) : Negative, Trace, 1+, 2+, 3+, 4+
 PROTEIN (60 secs) : Negative, Trace, 1+, 2+, 3+, 4+
 pH (60 secs) : Acidic (5.0, 6.0, 6.5), Alkaline (7.0, 7.5, 8.0, 8.5)
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 S.G. (45 secs) : 1.005, 1.010, 1.015, 1.020, 1.025, 1.030
iii. MICROSCOPIC EXAMINATION OF URINE
a. Centrifuge the test tubes for 5 to 10 mins.
b. Decant the supernatant fluid. Gently mix the test tube to

resuspend the urine sediment.
c. Transfer a small amount of urine sediment in a slide with

coverslip.
d. Focus the microscope under the low power objective and then
examine under the high power objective. Note the cellular
constituents.
REPORTING
 ESTIMATES (RARE, OCCASIONAL, FEW, MODERATE, MANY)
- Epithelial Cells
- Yeast Cells
- Amorphous Phosphates
- Mucus Threads
- Crystals
- Bacteria
- Amorphous Urates
 NUMERICAL REPORT PER HPF (HIGH POWER FIELD)
- Pus Cells/WBCs
- RBCs
- WBC in clumps
- Trichomonas vaginalis
 NUMERICAL REPORT PER LPF (LOW POWER FIELD)
- Casts (Hyaline, Cellular, Coarse Granular, Fine Granular, Waxy, Broad)

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B. ROUTINE FECALYSIS
SPECIMEN:
Use pea-sized or thumb-sized freshly collected stool.
i. GROSS EXAMINATION OF STOOL
PROCEDURE
1. Label the specimen bottle according to the information in the request

slip.
2. Examine the color and consistency of the stool.
3. Observe if the sample has streaks of mucus or blood which may indicate
the presence of parasites.
REPORTING:
 COLOR : Brown, Yellowish Brown, Dark Brown, Green, Black,

Red, etc.
 CONSISTENCY : Formed, Semi-formed, Soft, Mucoid, Watery
ii. MICROSCOPIC EXAMINATION OF STOOL (DIRECT FECAL SMEAR

AND IODINE MOUNT)
PROCEDURE
1. Label the slide according to the information in the request slip.
2. Put a drop of NSS at the center of the left half of the slide and a drop of
iodine solution at the center of the other right half of the slide
3. Touch and poke the various areas of the stool specimen and
bloody/mucoid portion and make an emulsion in a drop of NSS by
mixing well with an applicator stick
4. Place a cover slip on the smear gently to avoid air bubbles
5. Scan the whole smear from left to right, up and down or vice–versa
without missing any area.
6. Examine under LPO and HPO
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REPORTING
 NEGATIVE: NO OVA OR PARASITES SEEN
 NUMERICAL REPORT PER HPF (HIGH POWER FIELD)
- Pus Cells/WBC
- RBC
- Parasites (cyst, trophozoites, ova)
 ESTIMATES (RARE, OCCASIONAL, FEW, MODERATE, MANY)
- Bacteria
- Yeast Cells
- Fat Globules
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PROCEDURES FOR RECEIPT, PERFORMANCE AND

REPORTING OF RESULTS OF ROUTINE & STAT
REQUESTS FOR LABORATORY EXAMINATIONS
A. SPECIMEN WORKFLOW (IN GENERAL)
1. Patient goes to the laboratory with request from the doctor.
2. Receptionist checks request of patient before charging.
3. Receptionist informs patient of preparations necessary for certain

examinations, charges, issuance of reports and specimen collection. If
no blood tests are requested, the patient is asked to collect the
necessary samples.
4. Staff ensures proper identity of patient and extracts blood.
5. Patient is informed when to claim results.
6. Patient goes to releasing section to claim results at the designated time

and day.
B. PRE-EMPLOYMENT PHYSICAL EXAMINATIONS
 All pre-employment patients will first undergo physical examination by

the physician before doing any laboratory procedure.
 Routine laboratory test request follow from agreed package.
 Information nurse issues slip for laboratory test.
 Laboratory requirements/specimens are received by the

receptionist/phlebotomist together with the patient routing slip.
Phlebotomist does the blood extraction and separates blood sample for
hematology, chemistry and other approved blood tests requested.
 Specimen container should be properly labeled with patient’s name,

assigned number (provided by the receptionist), date and time of
collection.
 Medical technologist in-charge for analysis picks up specimen and

performs the test process.
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 Specimen report submitted to clerk/typist for official report.
 Medical technologist checks and signs the official report while the
clerk/typist collates and submits them to the Record section.
C. WALK-IN PATIENT/CONSULTATION
 Information receives doctor’s order slip from the patient.
 Information does verification of payment update by terminal inquiry.
 Non-questionable accounts are issued slip for laboratory test.
 For questionable accounts, the information prepares charge slip for

update and issues receipt of accounts update together with laboratory
slip.
 Laboratory receptionist/phlebotomist receives issued slip, records the

test on the laboratory registry and does the ordered procedure from
extraction of blood sample to receiving of submitted qualified sample
for analysis.
 Receptionist informs the patient where and when to claim the results
through the issuance of a claim slip.
 Medical technologist in-charge for analysis picks up specimen and

performs the test process.
 Specimen report submitted to clerk/typist for typing of official report.
 Medical technologist checks and signs the official report while the
clerk/typist collates and submits them to the Record section.
D. HANDLING COMPLAINTS
 The medical technologist involved will handle the complaint directly

with utmost courtesy.
 The clinic operations manager may mediate between the complainant

and the involved laboratory staff
 If not settled, a formal complaint may be filed to clinics operations

manager who will deal with it accordingly.
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E. RELEASE OF REPORTS
 All consultation results will be released on the same day.
 All annual results will be released on the following five (5) working
days.
 All thyroid, hepatitis, HbA1c, TPAG, B1 and B2 and send out

examination results will be released after 1-2 days depending on the
procedure to be done.
 STAT requests are done immediately when received. Results are

released after an hour.
 All laboratory results shall be forwarded to medical records department

for filing and release to the attending physician or to the patient upon
specific authorization by the attending physician.
 All patient information is to be held in strict confidentiality and released

only to the clinic personnel and the physician who is directly involved in
the care of the patient.
 Follow up of results may be done by the medical technologists of the

clinic. The date, time and the medical technologists who obtained and
relayed the result should be recorded.
 In case of delay in release of result, the patient should be informed

immediately, informing them of the reason for the delay and when the
result will be available.
 The turnaround time schedule shall be strictly followed.
F. STAT REQUEST
 When there is a STAT request from the attending physician, the patient
is accompanied by the clinic nurse to the laboratory department.
 The medtech on duty will accommodate first or prioritize the said

patient for whatever laboratory request he/she needed.
 Performance of laboratory examination be done immediately after the

medtech on duty
 Collected the specimens
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 Results will be released immediately after the performance of the

laboratory examination and will be given to the attending physician.
Results must be signed by the medtech and the pathologist.
G. SPECIMEN REJECTION
Criteria for Specimen Rejection
 Specimen did not meet the minimum amount of sample required.
 Patient did not follow specific preparation and collection requirements.
 Unlabeled or improperly labeled specimens.
 Contaminated specimens.
 Clotted blood specimens.
 Grossly hemolyzed blood specimens.
H. PROCEDURE IN CASES OF SPECIMEN REJECTION
1. The patient should be informed immediately for all the test results that
could not be released on the target days, indicating the reason why the
specimen was rejected.
2. The specimen that has been rejected is relayed to the medical

technologist on duty. The reason, time relayed and the name of the
person receiving the endorsement is indicated.
I. PROCEDURE IN CASE OF MISLABELED SPECIMEN
1. Do not assume any information about the specimen.
2. Do not re-label an incorrectly labeled specimen.
3. Do not discard the specimen until the investigation is complete.
4. Leave the specimen exactly as you received it; put in the refrigerator for
preservation until errors are resolved.
5. Notify the attending physician or patient immediately.
6. Identify problem on specimen requisition with date, time and your

initials.
7. Any action taken should be documented on the requisition slip.

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J. REPEAT TESTING
 A repeat test on adequate samples may be done for verification.
 All rejected specimens will be recommended for repeat testing using a

new sample.
 The attending physician and patient shall be informed immediately if

repeat testing is necessary.
 Serum is specimen of choice.
 Serum should be separated within one (1) hour from the time of
collection.
 Serum can be stored for one (1) week in the freezer.
 If the specimen will be transported to the laboratory, it should be put in

a cool container, preferably with ice packs to avoid unnecessary changes
in the sample.
 Serum will be discarded after one (1) week.
 Glucose test must be done within two (2) hours of collection.
 Bilirubin and protein – serum may be stored overnight in a refrigerator.

Bilirubin specimens should always be stored in the dark.
 Calcium – serum must be separated from the clot within 30 minutes

otherwise calcium diffuses into the cells. Serum can be kept overnight in
a refrigerator.
 Transaminase (SGOT and SGPT) – serum may be stored overnight in a

refrigerator.
K. SPECIMEN FOR ROUTINE COMPLETE BLOOD COUNT (WHOLE BLOOD)
 Fasting and non-fasting specimens are acceptable.
 At least 2.5 or 4.5 mL of blood is required.
 Specimen must be collected in EDTA tube.
 Specimen must be processed within the day.
 Specimen is discarded after three (3) days.
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L. SPECIMEN FOR ABO AND RH TYPING
1. Specimen can be collected directly to a slide for immediate analysis, but

if analysis cannot be done immediately, it should be collected in EDTA
or heparinized tube.
2. Specimen can be discarded immediately after procedure in a yellow

coded waste disposal container.
M. SPECIMEN FOR PERIPHERAL BLOOD SMEAR
1. Direct blood smear is acceptable but smear from an EDTA specimen is

recommended.
2. Specimen can be discarded after one (1) month.
3. Specimen must always be accompanied by a CBC result before

processing.
N. SPECIMEN FOR THYROID FUNCTION TEST (SERUM)
1. Fasting or non-fasting specimens are acceptable.
2. At least 5 mL whole blood in plain tube is required.
3. Specimen must be collected in a red top or plain test tube.
4. Specimen can be stored for up to one (1) month in the freezer.
5. Discard specimen after one (1) week from the date of analysis.
O. SPECIMEN FOR HEPATITIS PROFILE (SERUM OR PLASMA)
1. Fasting or non-fasting specimens are acceptable.
2. At least 5 mL whole blood in plain tube is required.
3. Specimen must be collected in a red top or EDTA tube.
4. Serum is preferred over plasma for longer storage.
5. Serum can be stored for up to one (1) month in the freezer.
6. Discard specimen after one (1) week from the date of analysis.
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P. SPECIMEN COLLECTION, HANDLING AND DISPOSAL (IN GENERAL)
1. All containers and slides are clearly labeled with the patient’s name and
the date the specimen was taken.
2. Patients are instructed clearly on how to collect the specimen in terms

which they can fully understand.
3. Proper techniques in collection of specimen are observed.
4. Disposal of specimens: Urine samples after testing should be drained in

the sink and flushed with sufficient amount of water. Stool specimens
should be disinfected with 10% bleach or Lysol and should be buried.
Blood samples should be disinfected with 10% bleach or Lysol before
disposal.
Q. SPECIMEN FOR URINALYSIS (URINE)
1. The patient can be either in fasting or non-fasting state.
2. Midstream catch is the ideal sample.
3. Collection can be done anytime of the day but morning specimen is

recommended.
4. At least 5 mL of urine is needed.
5. Container must be clean and dry.
6. Sample must be submitted in the laboratory within two (2) hours of

collection.
7. Specimen must be disposed in the yellow trash bag.
8. Patient should be advised not to take vitamin C and salicylates to avoid

false-positive results for urine glucose.
R. SPECIMEN FOR PREGNANCY TEST (URINE OR SERUM)
1. Collection can be done anytime of the day.
2. At least 5 mL of urine is needed.
3. Container must be clean and dry.
4. Turbid specimens are centrifuged before processing.
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S. SPECIMEN FOR ROUTINE FECALYSIS (STOOL)
1. Collection can be done anytime of the day.
2. Specimen should be at least pea-sized or thumb-sized.
3. Specimen should be collected directly to a wide mouth, screw cap, clean

and dry container, avoiding contamination from environment.
4. Specimen must be submitted within three (3) hours from the time of
collection. For suspected cases of amoebiasis, the specimen must be
processed within one (1) hour of collection.
5. Specimen must be disposed immediately in yellow-colored waste

disposal container.
T. RECEIVING AND RECORDING OF SPECIMENS
1. All specimens received shall be logged in the Daily Registry Sheet,

separate for Consultations and Annual/Pre-employment.
2. The laboratory shall have logbooks for recording specific tests received
and done. These include:
a. OPD logbook – data of all out-patients who undergone laboratory

procedures.
b. Hematology logbook – data of all patients requesting CBC, blood

typing and Rh typing.
c. Urinalysis logbook – data of all urinalysis and pregnancy test of

all patients.
d. Fecalysis logbook – data of all fecalysis patients.
e. Blood chemistry logbook – data of all FBS, RBC, Cholesterol, TAG,

HDL/LDL, BUN, Creatinine, BUA, etc. of all patients.
f. Serology logbook – data of all HBsAg Screening of patients.
g. Miscellaneous logbook – all data of patients who undergone

procedures that do not fall to any category logbooks.
h. Send-out logbook – all data of patients whose tests are not

available in the laboratory and are sent-out to other laboratories
and hospitals for processing.
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PROCEDURES FOR REPORTING OF WORK LOAD,

QUALITY CONTROL, INVENTORY CONTROL, WORK
SCHEDULE AND ASSIGNMENTS
I. POLICY/GUIDELINES
 The Chief Medical Technologist shall designate the laboratorians to
their assigned section every end of the month with which it shall
serve as the work schedule of the laboratorians on the next month. It
shall be acknowledged by all the personnel and must be posted on
the bulletin board.
 There shall be two (2) medical technologists and one (1) laboratory
aide per duty/day
 Laboratorians should be well oriented on about their corresponding

workload on their designated area.
 If in any case one of the laboratorians cannot report for duty, the
chief medical technologist may cover for the position and may work
as a generalist.
 There shall be proper endorsements with regards to the

transition/rotation in the different sections/areas and shall be
recorded in the endorsement logbook.
 Quality control reports such as Levey-Jennings Chart must be

accomplished and reported to the Chief Medical Technologist.
 Inventory control reports must also be properly accomplished and

must be reported on a weekly basis to avoid supplies shortage.
A. DIRECT WORKLOAD
- It refers to the personnel labor effort which involves direct patient

interaction and the Pre-analytic, Analysis and the Post-Analytic
phase in the clinical laboratory.
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B. INDIRECT WORKLOAD
- It accounts for all daily testing-related tasks performed by

laboratorian that do not directly involve patient specimens, test data,
or the patients themselves. Such as:
a. Daily instrument calibration
b. Planned instrument and equipment maintenance
c. Performing quality control
d. Performing proficiency testing
e. Stocking supplies
f. Filling out paperwork/data entry
g. Clerical work
h. Managing phone calls
i. Report revisions
j. Repeat testing clerical tasks
k. Test development
l. Unplanned instrument and equipment maintenance
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PROCEDURES FOR REPORTING AND ANALYSIS OF

INCIDENTS, ADVERSE EVENTS
 In case, that there will be an incidents or adverse events occur on

that day, the medical technologist on duty will document the said
incidence indicating the date, time, name of the patient,
laboratory tests to be done.
 Short narrative report and corrective measures will be written on

the logbook provided by the clinic.
 The pathologist will be informed regarding the incidence report

and also the medical director of the clinic.
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PROCEDURE FOR RETENTION OF THE RECORDS
 For pre-employment applicants, laboratory results will be retain

up to 3 months. OPD patients laboratory results will be retain up
to six (6) years.
 Records for documentation purpose will be retained at the

laboratory for five (5) years.
 Request/Referral slip should be retained in the clinic for one (1)

year.
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QUALITY ASSURANCE PROGRAM AND

CONTINUOUS QUALITY IMPROVEMENT
I. Objectives
The laboratory must always involve quality assurance methods in the
entire testing process: pre-analytical, analytical (testing), and post-
analytical processes. This program must:
 assess the effectiveness of the laboratory’s policies and

procedures;
 identify and plan corrective actions;
 assure accurate, reliable, and prompt reporting of test results;
 Assure the adequacy and competency of staff.
II. Standards in Internal Quality Assurance Program

1. Patient Test Management
The laboratory and its personnel must follow all the protocols
established and written in this manual. The Chief Medical Technologist
must monitor and evaluate the laboratorians periodically if protocols
regarding patient test management are followed firmly. Such
procedures that must be evaluated are:
 Patient preparation
 Specimen collection
 Labeling
 Test requisition completeness
 Use of appropriate criteria for specimen rejection
 Timely reporting of results
 Accuracy and reliability of test reporting systems
 Storage and retrieval of result
96 | P a g e
2. Quality Assurance/Control Tests
The laboratory must run quality control tests in every procedure and
section on a periodic basis. This will allow prevention of reporting of
poor quality results at the same time prepare for external proficiency
testing. The laboratory must always ensure that Control Kits and
Samples are always available. The Levey-Jennings Chart must be
accomplished for the quantitative tests such as Routine Chemistry and
Routine Hematology. If the value is within +2 SD, the run can be
accepted as “in-control”.
3. Quality Assurance Records
All records must be properly kept and filed accordingly. Laboratorians

task is to ensure that they will perform quality control tests and report
it to the Chief Medical Technologist. The head of the laboratory must
also check if all documents in QA are available and updated.
4. Quality Assuarance Review with Laboratory Personnel
The Chief Medical Technologist must monitor and evaluate the

laboratorians periodically. In addition to this, the head of the laboratory
must discuss the issues and take corrective actions to prevent
recurrences of problems.
5. Complaint and Patient Suggestions
The laboratory must have a system to assure that all complaints and
problems are documented. Investigations must be made and corrective
action taken. The Chief Medical Technologist must document and report
to the head of the laboratory such complaints.
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PROCEDURES IN THE ACTUAL PERFORMANCE OF

THE EQAP ACTIVITIES ADMINISTERED BY THE
NRL’S
 The laboratory must participate in the External Quality

Assurance Program or Proficiency Testing conducted by the
designated NRL or other external proficiency program
mandated by DOH as part of the requirements for the renewal
of the License To Operate.
 External provider sends unknown samples for testing to a set
of laboratories, and the results of all laboratories are analyzed,
compared and reported to the laboratories.
 When the laboratory received the samples from the external
provider, proper inspection must be done by the laboratorian
on duty assuring that the specimens received are of good
condition.
 The laboratorian on duty performs the requested tests by the
NRL (external provider). To be successful, PT instructions must
be followed carefully, all paper work completed accurately and
results submission deadlines met.
 Performance of the requested tests was based on the standard
operating procedures of the laboratory.
 Results were returned or submitted to the requesting NRL’s
thru courier within a prescribed period of time.
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PROCEDURES ON REFERRAL & OUTSOURCING OF

EXAMINATIONS TO OTHER LICENSED CLINICAL
LABORATORIES
 Special chemistry and other laboratory examinations that

cannot be performed in the laboratory are being referred to
other licensed clinical laboratory.
 After specimen collection, proper specimen preparation and

labeling is done by the laboratorian on duty.
 The referrals were made by the laboratorian indicating to the

referral slip the name of the patient, age, gender, laboratory
examination requested, the type specimen submitted and its
quantity, date & time and properly signed by requesting
laboratorian on duty.
 Hard copy results from the outsourcing laboratories were

delivered to the laboratory once the requested laboratory
results were available.
99 | P a g e

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1045 ME Governor’s Drive Oregano St. Brgy.

Maduya, Carmona, Cavite

This manual contains the Standard Operating Procedures of

OCCUMEDICA HEALTH CARE SYSTEM CORP.

OCCUMEDICA HEALTH CARE SYSTEM CORP., an institution-based secondary

 To give quality and affordable laboratory services to our clients.

 To be the service provider of choice to medical professionals and

 To promote, designed and implemented good laboratory

 To be compliant to the legislation and regulations in support of

POLICIES FOR HIRING, ORIENTATION AND

HIRING AND EMPLOYMENT

 A licensed physician certified in Clinical Pathology by the

 A licensed physician with three (3) months training on clinical

 Chief Medical Technologist

 Graduate of Bachelor of Science in Medical Technology;

 Board Certified by the Philippine Regulatory Commission;

 Professional competence in laboratory practice and skill in

 Expertise required using and demonstrating the use of medical

 Broad expertise and expertise in laboratory department operation

 Broad expertise on laboratory procedures and tests;

 Has the capability to correlate results and findings;

 Possess strong leadership abilities, management, people and

 Graduate of Bachelor of Science in Medical Technology;

 Board Certified by the Philippine Regulatory Commission;

 Good communication and presentation expertise;

 Responsible, mature and can work effectively under pressure;

 Resourceful and well organized;

 Familiar with use of automated equipment and ability to operate

 Perform manual laboratory tests.

Section 2: Duties and Responsibilities of Personnel

 Supervise the facilities and all aspects of Clinical Laboratory work;

 Supervise all the Laboratorians;

 Implements the Standard Operation Manual that governs the

 Supervise and directs all analytical procedures of the Clinical

 Assures Quality of all Clinical Laboratory Test Results;

 Reads Clinical Pathology slides and provides interpretations;

 Evaluate and recommends reagents, supplies and equipment;

 Reviews the work of Laboratorians especially those of critical

 Interviews patient for alternative medical explanations, if

 Review rejects and refers for retesting, reconfirmation all

 Implements remedial actions necessary to maintain satisfactory

 Directs protocol for preventive maintenance of equipment

 Propose new strategies and additional clinical laboratory

 Provides comprehensive, continuing training and education of

B. Chief Medical Technologist:

 Formulates the department's standard policies and procedures;

 Ensures full compliance on the set SOPs of the department, of the

 Prepares all necessary documents for securing or renewing all

 Reviews, coordinates and prepares requests for procurement of

 Ensures machines/equipment are functional and makes reliable

 Ensures that all supplies are available as required;

 Participates in the selection and training of staff;

 Ensures adequate staffing in the department at all times;

 Supervises and participates in the performance of all standard

 Ensures preparation and submission of required reports;

 Responsible for trouble-shooting when emergency arises in the

 Keeps herself/himself updated on the latest/recent development,

 Recommends and ensures that laboratory staff acquires

 Represents the Laboratory Department in the monthly