MANAGEMENT RESPONSIBILITY

1. MISSION VISION

MISSION

We are an institution committed to providing the best clinical laboratory service and quality health to all
patient we serve.

VISION

To be the market leader by becoming by becoming the leading laboratory provider of choice through
advanced high quality yet low-cost technology, exceptional health information and superior customer
service.

2. OBJECTIVE
 To be able to meet the challenges of an expanded health care program, bringing
laboratory service closer to Caviteños.
 To provide quality medical services to valued clients by networking with accredited
hospitals, laboratory and stand-alone clinics.
 To be able to provide quality laboratory services regardless of social status.
 To upgrade our health care services through an innovative concept.
 To provide efficient, effective and quality laboratory services at minimal cost.
 To be able to help in nation by building a healthy Filipino Community.

3. VALUES

 Integrity: We do the right thing.

 Caring: We do the kind thing.
 Excellence: We do the best thing
 Safety: We do the safe thing.

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 DOCUMENTED POLICY/ PROGRAM
1. POLICY ON CONTINUING PROGRAM FOR STAFF DEVELOPMENT AND TRAINING
1.1 PROVISIONS ON CONTINUING PROGRAM FOR STAFF DEVELOPMENT AND
TRAINING
1.1.1 The company shall allow the Pathologist, Medical Technologist, Laboratory
Technician and Phlebotomist to participate in any periodic orientation,
seminar workshop, trainings and symposia to upgrade the competencies of
the staff to assure quality, integrity, and effectiveness in the conduct of
medical, and clinical laboratory testing.
1.1.2 A yearly development plan shall be prepared in consultation with the
laboratory staff at the beginning of the year.
1.1.3 Provisions on continuing program for staff development and training.
1.1.3.1 The Head of the Laboratory shall submit the list of tentative annual
scheduled seminars to be submitted to the management.
1.1.3.2 The company shall pay for the expenses including seminar fees,
foods, transportations and accommodation of the participant.
1.1.3.3 The days covering the said seminar/trainings shall be considered
as working day for the participant and should be pain accordingly.
1.1.3.4 The company or participant may seek solicit financial assistance
from their partners such as the suppliers.
1.1.3.5 The participant shall make a report (post seminar report) about the
training or seminar and submit to the Head of the Laboratory with
copy furnished to the administrative office.
1.1.3.6 Copies of certificate of trainings and seminars shall be submitted.

1.2 DOH WITH CORRESPONDING CPD UNITS

1.2.1 PCQACL – Philippine Council for Quality Assurance on Clinical Laboratory
1.2.2 PAMET – Philippines Association of Medical Technologist
1.2.3 PBCC – Philippines Blood Coordinating Council
1.2.4 PSMID – Philippines Society of Microbiology and Infectious Diseases
1.2.5 PSP – Philippine Society of Pathologist
1.2.6 PAMLS – Philippine Association of Medical Laboratory Scientist
1.2.7 PHISMETH – Philippine Association of Schools of Medical Technologist

1.3 OTHER GOVERNMENT LEAD AGENCIES MAY CONDUCT SEMINARS AND TRAINING
ON THE FOLLOWING:

 Immunology and Serology

 Biosafety and Biosecurity
 Waste Disposal Management

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2. POLICY FOR HIRING, ORIENTATION AND PROMOTION FOR ALL LEVELS OF PERSONNEL
2.1 POLICY ON HIRING/RECRUITMENT
2.1.1 The management and selection committee shall strictly implement the criteria
for evaluation on all laboratory applicants.
2.1.2 Procedure:
2.1.2.1 The applicant shall submit documents like Curriculum Vitae,
scholastic records, certificate of employment from previous
employer, trainings and seminars.
2.1.2.2 The applicant shall submit himself for an interview to be scheduled
by the management.
2.1.2.3 A panel composed of the Pathologist, Chief Medical Technologist
and a representative from the management shall conduct the
interview and deliberation for all applicants.
2.1.2.4 The potential applicants shall be informed through the
management and shall discuss salaries, employment status,
benefits and pre-employment status.
2.1.2.5 Applicant shall submit clearances, government documents:
 Detailed Resume with 2x2 picture
 Valid PRC ID
 PRC Board Certificate
 PRC Board Ratings
 Diploma
 NBI/Police Clearance
 Certificate of Employment from previous employer (if
applicable)
 Certificate of good moral character for new graduates
 SSS number, TIN, Philhealth and PAGIBIG number
2.1.2.6 The applicant shall undergo a medical and laboratory examination
test on Complete Blood Count, Chest X-ray, urinalysis, fecalysis,
Drug test, and Hepatitis B antibody.

2.2 TERMS AND CONDITIONS OF EMPLOYMENT

2.2.1 A six (6) months probationary period shall be offered to the appointee for
evaluation of his/her performance. A recommendation from the Chief Medical
Technologist to be agreed by the administration if the appointee shall be
renewed of his contract extending for the next six (6) months. But needs
improvement or not to be renewed.
2.2.2 A regular employee shall be granted after successfully complied with all the
mandatory and company requirements and after satisfactory rating of
evaluation for six (6) months probationary period and is entitled to the
benefits provided by Law.

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 2.3 ORIENTATION
2.3.1 All newly hired personnel of Cavite Diagnostic Stroke Care Center INC., shall
have an orientation with the owner and Chief Medical Technologist. The
orientation may take two (2) days before the official start of employment.
2.3.2 The primary responsibilities of the new employee shall be clearly discussed.
The company shall explain the company’s mission, vision, goals,
organizational history, background, functional units, products and services,
administrative policies, culture and core values in order to ensure its proper
implementation.
2.3.3 Schedule of duty, benefits, and privileges including guidelines on vacation,
sick and emergency leaves shall be clearly discussed.

2.4 POLICY ON PROMOTION

2.4.1 The company through the selection committee shall develop a program of
personnel development and criteria for evaluation of performance of all
personnel and fields on their performance records as tool for selection on
candidates for promotion.
2.4.2 An employee shall be promoted when a junior position is created or when
there is a need to hire for another Medical Technologist.

3. POLICY FOR DISCIPLINE, SUSPENSION, DEMOTION AND TERMINATION OF PERSONNEL AT

ALL LEVELS
3.1 The management shall strictly enforce written code of professional conduct for maintaining
order and discipline for all laboratory personnel and known personnel.
3.2 It should be in mind that the primary purpose of these disciplinary actions is corrective not
punitive. The intention is to reform the offender and deter others from committing the same.

3.3 GENERAL RULES AND REGULATIONS

3.3.1 The written code of professional conduct/ discipline for all laboratory
personnel shall be enforced and known all personnel.
3.3.2 Any violations of the code of professional conduct shall be grounds for
suspension/termination of a laboratory personnel.
3.3.3 All violations, suspension and relevant actions shall be documented and filed
in the personnel’s personal records.
3.3.4 All suspensions shall be without pay. Unless otherwise provided all
terminations of cause shall carry with it automatic forfeiture of all separation
benefits.

3.4 OFFENSES AND DISCIPLINARY ACTIONS

3.4.1 Offenses on attendance and punctuality
3.4.1.1 Failure to notify the immediate superior or head of the human
resource department of absence at least one (1) hour before
commencement of work hour.
3.4.1.2 Failure to file application for leave of absence and other
supporting documents prior to actual leave.
3.4.1.3 Abandonment or unjustifiable absence for at least three (3)
consecutive working days is subject for dismissal.

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 3.4.1.4 Habitual absences or absence for five days in one calendar month
even with notification with the immediate superior or head of the
HRD.
3.4.1.5 Accumulated tardiness for a total of one hundred twenty (120)
minutes within a month.
3.4.1.6 Unauthorized under-time or leaving workplace before the
completion of work hours, without clearance from the immediate
superior.
3.4.2 Offenses on wearing uniform/ appearance grooming
3.4.2.1 Failure to use identification card/ wear complete uniform during
work hours or within the company premises or whenever required.
3.4.2.2 Failure to immediately report lost or misplaced ID to the head of
the HRD
3.4.3 Offenses against persons
3.4.3.1 Engaging in or inducing another employee to engage in physical
altercation while within the company premises.
3.4.3.2 Simple discourtesy or use of disrespectful, abusive, indecent or
offensive language on fellow employee, client, guest or other
person doing business with the company.
3.4.3.3 Uttering unnecessary/ inappropriate remarks.
3.4.3.4 Threatening, coercing or harassing officers or fellow employees.
3.4.3.5 Scuffing, catcalls, unnecessary shouting or throwing of things
while at work, unnecessary name-calling or joking which might
offend other employees.
3.4.3.6 Acts of sexual harassment is subject for 5th offense
3.4.4 Acts of Dishonesty
3.4.4.1 Falsification, unauthorized alteration or destruction of company
documents or records is subjected to dismissal
3.4.4.2 Making false statement in any document officially submitted to the
company, including application for employment with the company
is subjected for dismissal.
3.4.4.3 False claim for pecuniary benefits/ monetary gain is subject for
dismissal
3.4.4.4 Forging signature of fellow employees or superiors is subject for
dismissal.
3.4.4.5 Attempted, frustrated or consummated misappropriation of
company funds or property is subject for dismissal.
3.4.4.6 Knowingly punching of employee’s proximity or time in with the
knowledge and consent of the latter. Both employees will be
subjected to 3rd offense.
3.4.4.7 Over-declaring overtime rendered subject for dismissal.
3.4.5 Offenses Against Company Interest
3.4.5.1 Unauthorized disclosure of any confidential information or trade
secrets acquired by an employee on account of his or her position.
3.4.5.2 Unauthorized copying of licensed software application and all
such acts that violate intellectual property rights.

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 3.4.5.3 Engaging, participating, directly or indirectly, in any transaction,
undertaking or business enterprise which amounts to conflict of
interest with the company.
3.4.5.4 Sabotaging or deliberately causing damage to company property
and products, in order to disrupt operations or cause losses to the
company.
3.4.6 Disciplinary Action
3.4.6.1 An employee will be dealt with disciplinary action which may
cause such as:
3.4.6.1.1 Misconduct
3.4.6.1.2 Incompetence
3.4.6.1.3 Insubordination
3.4.6.1.4 Inefficiency
3.4.6.1.5 Failure to satisfactory perform of the duties of
her/his position
3.4.6.1.6 Failure to satisfactory observe applicable
rules and regulations.
3.4.6.1.7 Failure to cooperate reasonable with his/her
superior or fellow employees.
3.4.6.2 The type of discipline should reflect the seriousness of the
problem.
3.4.6.3 All employees must be treated fairly and equally without regard to
race, color, religion, gender, national origin, age, physical
disability, and mental health.
3.4.6.4 In determining the level of discipline to impose, the department
should consider factors relevant to the situation at hand including,
but not limited to the following:
3.4.6.4.1 The nature and seriousness of the offense
3.4.6.4.2 The level of the performance of the employee
on his/her job.
3.4.6.4.3 The position the employee holds.
3.4.6.5 Level of discipline
3.4.6.5.1 First Offense = Verbal Counseling
 Direct the employee in performing his/her
duty verbally. Remind the employee of how
his duties are to be performed or to correct
the employee’s minor misconduct, error or
omission. Each verbal counseling must be
noted or recorded in the employee’s
personal file.
3.4.6.5.2 Second Offense = Written Warning
 Advice the employee of the misconduct, act,
omission, or failure to perform duties that
gave rise to the written warning. The
employee must sign the written warning to
acknowledge its receipt and a copy will be
placed in the employee’s personal file.

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 3.4.6.5.3 Third Offense = Suspension

A suspension is a temporary release from
duty of an employee for up to thirty (30)
calendar days without pay. A suspension is
used when a prior reprimand and written
warning does not produce satisfactory
results in correcting behavior.
3.4.6.5.4 Fourth Offense = Demotion
 A demotion is the voluntary reassignment of
an employee to a position with a lower pay,
and less responsibility. An employee may
be demoted when a prior reprimand, written
warning, and suspension do not produce
satisfactory result in correcting behavior or
performance.
3.4.6.5.5 Fifth Offense = Termination/Dismissal
 Termination is the voluntary discharge of an
employee. A discharge is appropriate when
a prior reprimand, written warning,
suspension and demotion does not produce
satisfactory results in correction his/her
behavior.
3.4.6.5.6 Offenses that are subject for
termination/dismissal will be implemented
immediately.

3.5 TERMINATION OF EMPLOYMENT BY THE COMPANY FOR JUST CAUSE:

3.5.1 The following are just causes under Article 282 of the Labor Code:
3.5.1.1 Serious misconduct or willful disobedience by the employee of the
lawful orders of the company or its representative in connection
with his work.
3.5.1.2 Gross and habitual neglect by the employee of his/her duties.
3.5.1.3 Fraud or willful breach by the employees if the trust reposed in
him by the company or it’s duly authorized representatives.
3.5.1.4 Commission of a crime or offense by the employee against the
person of his employer or any immediate member of his family or
duly authorized representative.
3.5.2 Other analogous causes defined in the code of ethics
Termination of employment under just cause forfeits encashment of vacation
leave (VL) credit and payment of incentives.

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 3.6 NOTICE OF DEMOTION OR TERMINATION
3.6.1 Unless otherwise specified in a written contract or by law, may be demoted or
terminated without cause and without any reason being given for such action.
3.6.2 Whenever the employee’s supervisor and medical director or operations
manager determine that an employee should be demoted or terminated, the
medical director or operations manager will send a written notification to the
employee that such a recommendation will be made by the next regular
board meeting or a special board meeting.
3.6.3 If an employee is recommended for demotion or termination, the notice will
include:
3.6.3.1 The date of determination
3.6.3.2 The nature of the determination and the effective date.
3.6.3.3 The reason(s) for determination
3.6.3.4 The rights of the employee to examine his/her personnel file and
examine all evidence which has a bearing on such determination.
3.6.3.5 The employee’s appeal rights.

4. POLICY ON MANAGEMENT REVIEW

4.1 Regular staff meeting will be conducted every month or as needed, in order to assess and
resolve different laboratory issues; create updates and improvements on current policies
and guidelines, and other related topics to ensure quality laboratory services are given to
patients. The meeting will be led by the head of the laboratory, the Pathologist, or the Chief
Medical Technologist.
4.2 Each meetings held, will be documented in the following manner:
4.2.1 Date and time of meeting
4.2.2 Attendance and signature of participants
4.2.3 Agenda of the meeting
4.2.4 Actions taken, plans or resolutions
4.2.5 Signature of approval by the head of the laboratory or chief medical
technologist.
4.3 All activities for evaluations and monitoring shall be documented as well, such as logbooks,
checklist of supplies, inspection reports, purchasing or procurement and acceptance of
supplies.
4.4 The company consider attendance as fair reflection of diligence and sense of responsibility
of its employees. Strict observance or requirements of good attendance and punctuality are
important for the efficient operation of the company.
4.5 Policy statement and Conditions on attendance and work schedule
4.5.1 The company follows eight (8) hours work schedule from Monday to Saturday
which starts at 6 A.M. and ends at 3 P.M., 7 A.M. to 4 P.M and 8 A.M to 5
P.M.
4.5.2 Regular and special holidays designated by the law, and every Sunday of the
month are considered rest day of the employees.
4.5.3 The company may change, revise, or alter work schedule at its sole
discretion whenever advisable or necessary in the future either as permanent
or as temporary measure.

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 4.5.4 Employee who renders work at least one (1) hour beyond the eight (8) hour
work schedule or during rest day or holidays, shall be considered to have
rendered over-time work and is entitled to do equivalent compensation for
such, provided suck overtime work have been previously authorizes by the
immediate supervisor.
4.5.5 The schedule of lunch and coffee breaks are as follow:

BREAK DURATION

Morning snack 15 minutes

Lunch 1 hour

Afternoon Snack 15 minutes

4.6 Time keeping

4.6.1 Employees required to report for work by 6:00, 7:00 and 8:00 in the morning
and to formally start work by the said time. Work rendered before the
scheduled time in the morning shall not be considered overtime work,
likewise, employees who report to work ten (10) minutes after scheduled time
in the morning shall be considered tardy.
4.6.2 All employees of the company are expected to complete the eight (8) hours
working time. Employees who log out before their scheduled log out shall be
considered to have incurred under-time, meanwhile work rendered after the
end shift for at least one (1) hour shall be considered overtime work, provided
that both are approved by their immediate supervisor.
4.6.3 All employees who wish to have lunch outside must log out/log in in the time
record/biometrics.

4.7 Tardiness
4.7.1 Any employees who report for work past ten (10) minutes the start of working
hours shall be considered tardy.
4.7.2 Working lost due to tardiness shall be deducted from the employee’s salary.
4.7.3 Employees who are tardy must complete the required eight (8) hour work
schedule before they can be permitted to render overtime work.

4.8 Under-time work

4.8.1 The company frowns on employees who cease to work earlier than their work
schedule. It therefore follows that employee can only log-out after their work
schedule. Any employee who logs out before their end work schedule time
shall be considered to have incurred under-time.
4.8.2 Under-time or leaving before the end work shift is either pre-approved or
noted after the fact by the employee’s immediate superior.

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4.9 Over-time work
4.9.1 Over-time work always results in additional expenses for the company on
terms of additional salary costs, salary premium, air conditioning, electricity,
etc., over-time work, being largely unsupervised, is probably also not as
productive as work done on regular office hours. For these reasons, the over-
time work can be avoided with proper planning.
4.9.2 All over-time work must be pre-approved using the over-time request for,
over-time authorization is granted on a day-to-day basis, depending on
current workload and business conditions.
4.9.3 Overtime on weekend and holidays shall not exceed eight (8) hours and shall
not be less than two (2) hours.
4.9.4 Overtime shall be paid in accordance with the law.
4.9.5 Payment shall be limited to overtime work authorized on the overtime request
form.
4.9.6 Overtime rendered in any month shall be paid the following month.

4.10 Vacation Leave

4.10.1 Leave Credits
4.10.1.1 All regular employees are entitled to Vacation Leave of five
(5) days per year, or one (1) day per month.

4.10.1.2 Leave credits may be taken after being earned at any but
not beyond the employee anniversary date of the following
calendar year.
4.10.2 Availments
4.10.2.1 Availment of leave credits shall be scheduled in advance.
Each employee, therefore, shall prepare their desired vacation
leave for submission to the HRD one (1) week before the said
date of leave. In preparing such schedule, due consideration shall
be given to the smooth operation of the company ensuring that
there will be minimal effect on operation, production, and quality
service. The guidelines are as follows:
4.10.2.2 Vacation leaves should ideally be scheduled not more than
three (3) times a year at a period of not less than four (4) days
may be allowed.
4.10.2.3 Leaves outside of the schedule may only be granted in
highly meritorious cases such as when there is an emergency or
situation which very clearly requires the presence of the employee
elsewhere or prevents in coming to work for which case, such
availments shall be deducted from the schedule of vacation leave.
4.10.2.4 Except, as allowed in accordance with this guideline, all
leave shall be taken in accordance with the aforementioned
leaves schedule but shall have prior approval nonetheless of the
employee’s immediate supervisor, using official leave form.

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 4.10.3 Absence without leave (AWOL)
4.10.3.1 An employee shall be considered AWOL when he/she is
absent from work for three (3) consecutive days without prior
authorization or notification to his/her immediate supervisor.

5. POLICY FOR HANDLING COMPLAINTS AND CLIENT FEEDBACK AND OTHER INCIDENTS
5.1 Complains handling process is consists of two (2) distinct levels:
5.1.1 Resolving the matter between the staff and the client.
5.1.1.1 Complaints at this level may involve simple misunderstanding or
provide an opportunity for a grievance to be heard, and should
initially be dealt with informally by the staff member(s) involved.
5.1.2 Referral to the Owner
5.1.2.1 If complaint(s) is not resolve by the staff involved and client, the
matter will be referred to the owner of the company.
5.1.2.2 The role of the owner who also acts as Client Service Manager is
to:
5.1.2.2.1 Provide assistance to staff and clients in the
complaints handling process.
5.1.2.2.2 Maintain a register of complaints received.
5.1.2.2.3 Maintain and review the complaints
5.1.2.2.4 Maintains the record of outcome of the
complaints.
5.2 Complaints
5.2.1 In cases wherein complaints were encountered by the laboratory. Staffs
should follow the guidelines below:
5.2.1.1 Step One (1). Assessment
5.2.1.1.1 The complaint must be first assessed in order
to identify the gravity of the complaint and
who needs to be notified.
5.2.1.1.2 Complaints are acknowledged, taking the
contact numbers of the client for the feedback
and follow-up
5.2.1.2 Step two (2). Information Gathering
5.2.1.2.1 After assessment, complaints must be asked
to fill out the laboratory complaint form
indicating the date, time, person(s) involved,
and other important related details. Likewise,
written report and explanation must be
immediately secured by the staff involved in
the incident. The Chief Medical Technologist,
Pathologist and Clinical Administrator must be
notified in cases where-in the complaints are
unresolved, involved serious consequences,
complex medical issues or a number of
different staff, needed action that is

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 beyond the responsibility of the staff at point
of service or needed to be dealt with by
someone with more authority, which is the
owner of the company.
5.2.1.3 Step Three (3). Resolution and Outcome
5.2.1.3.1 Once appropriate and sufficient documented
information and data where obtained. Options
for resolutions must be discussed jointly with
the patient. Explanation must be given in a
factual way that can be understood by the
patient and apology must be always given in
a humble and sincere manner. Reviewing the
laboratory procedures and policies must also
be taken in to consideration.
5.2.1.4 Step four (4). Implementation/Action taken
5.2.1.4.1 Corrective and appropriate actions, sanctions
and measures in line with the sections of the
laboratory management standards must be
implemented upon approval of the Chief
Medical technologist, Pathologist, and Clinical
Administrator to prevent further complaints
and improve quality management within the
laboratory.
5.2.1.5 Step Five (5). Record
5.2.1.5.1 The laboratory will keep a record and
summarize the complaint for continuous
improvement process and monitoring though
regular review.

5.3 Feedback, Comments and Suggestions

5.3.1 Suggestion boxes with accompanying forms are placed within the reception
area. This is to ensure that the patient’s recommendations, suggestions and
comments will be noticed. Suggestion box will be opened evert end of the
week and will be assessed based on importance and significance of the
laboratory department. Substantial feedbacks will then be recorded and will
be discussed during meetings in order to formulate appropriate responses,
plans, or solutions that can be implemented upon approval by the Pathologist
and Clinical Administrator.

5.4 Incidents
5.4.1 Incidents within the concerns of the laboratory must be immediately stated
and the incident report (IR) must be secured.
Assessments, person involved and action/s taken must also be recorded and
filed within the laboratory.

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 DUTIES AND RESPONSIBILITIES OF ALL GENERAL LABORATORY PERSONNEL
1. JOB DESCRIPTION AND FUNCTION
1.1 Each position should have a written job description which should contain the following:
1.1.1 Duties
1.1.2 Functions and responsibilities
1.1.3 Measurable standards of performance of the tasks
1.1.4 Hours of work
1.1.5 Who to communicate with.
1.2 Each staff shall be required to sign their job description form which should be filled in their personnel
record.
1.3 Each staff should be required to document the fact that they have read the required manuals that
apply to their tasks.

2. DUTIES AND RESPONSIBILITIES

2.1 Head of the Laboratory/Pathologist
2.1.1 General and over-all supervisor of the laboratory and all examinations performed under
the laboratory.
2.1.2 General supervision of conduct of all laboratory personnel.
2.1.3 Evaluates and ensures the quality of supplies/reagents used in the laboratory with the
recommendation of the Chief Medical Technologist.
2.1.4 Provides other administrative support services such as communications, security and
maintenance.
2.1.5 Formulates and implements standard operation manual that governs the operation of the
laboratory.
2.1.6 Assures quality of all laboratory test results.
2.1.7 Interpret, sign and issues laboratory results.
2.1.8 Implements remedial actions necessary to maintain satisfactory operation and
performance in the laboratory.
2.1.9 Directs protocols for preventive maintenance of equipment.
2.1.10 Provides comprehensive, continuing training and education of personnel related to the
laboratory.
2.1.11 Must have a valid PRC license and certificate of good standing

2.2 Chief Medical Technologist

2.2.1 Supervise all laboratory personnel and the laboratory
2.2.2 Performs quality control to ensure proper functioning of instruments, reagents, and
procedures.
2.2.3 Ensures quality assurance of laboratory procedures.
2.2.4 Establishes and implements procedures to evaluate laboratory tests.
2.2.5 Researches and investigates problems with the clinical laboratory procedures and
makes or recommends modifications and corrections as appropriate.
2.2.6 Reviews and trouble shoot minor discrepancy in clinical and laboratory results.
2.2.7 Validates, calculates, and tabulates results of tests performed, posts findings to log
books and quality control records and make reports of observations.
2.2.8 Responsible for inventory and census of reagents used.
2.2.9 Relays problems to Pathologist for immediate action.

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 2.2.10 Supervises and performs all analytical procedures in the laboratory.
2.2.11 Train newly hired staff or volunteers performing related work
2.2.12 Monitors usage of laboratory supplies
2.2.13 Responsible for requisition of laboratory supplies
2.2.14 Performs miscellaneous job-related duties as may be assigned by the Pathologist.
2.2.15 Must have a valid PRC license

3.3 Medical Technologist

3.3.1 Receives, logs and charges laboratory requests.
3.3.2 Blood extraction of patient.
3.3.3 Gives related instructions and requirements to patients prior to blood extraction
3.3.4 Performs all analytical procedures in the laboratory
3.3.5 Performs tests in all sections of the laboratory
3.3.6 Operates complex apparatus, instruments and machines.
3.3.7 Use standards and controls to improve reliability.
3.3.8 Works under pressure with accuracy and time-management skills and precision.
3.3.9 Adheres to high ethical standards of performance.
3.3.10 Enters and prints laboratory results in the computer
3.3.11 Issues and signs laboratory test results
3.3.12 Maintains orderliness and cleanliness in the laboratory.
3.3.13 Participate in providing health instructions to clinic patients, patient’s relative and
community group.
3.3.14 Must have a valid PRC license

3.4 Laboratory Technician and Phlebotomist

3.4.1 Collect/extract blood samples of the patient with care
3.4.2 Assist the medical technologist in the performance of laboratory and procedures
3.4.3 Responsible for maintaining general cleanliness of work areas.
3.4.4 Prepare laboratory monthly reports.
3.4.5 Type laboratory results.
3.4.6 Log laboratory result.
3.4.7 Performs other tasks that may be assigned as needed.

4. EVALUTATION OF STAFF COMPETENCY

4.1 The competency level of each staff should be continuously evaluated.
4.2 Validation can be done through external certification.
4.3 Certification or periodic informal sessions at various levels.

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5. WORK ASSIGNMENT AND SCHEDULES
5.1 To maximize laboratory operations, medical technologist is being rotates in different sections on
weekly basis base on the schedule prepares by the Chief Medical Technologist. There are three (3)
shifts of medical technologist: 6AM-3PM; 7AM-4PM; 8AM-5PM, Monday to Saturday. The
phlebotomist and laboratory technician’s schedule are from 7AM – 4PM Monday to Saturday. The
schedule may change if one or more staff if off and/or on leave. Schedules are assigned by the
Chief Medical Technologist and approved by the head of the laboratory.
5.2 The clinical laboratory offers a wide-range of examinations/tests. Some tests offered are being
referred to our partner laboratories. The laboratory is composed of chemistry section, hematology
section, and microscopy section. Immunologic tests are done in the hematology section of the
laboratory.

MON TUES WED THURS FRI SAT SUN

MEDTECH 1 6AM- 6AM- 6AM- 6AM- 6AM- 6AM- OFF

3PM 3PM 3PM 3PM 3PM 3PM

MEDTECH 2 7AM- 7AM- 7AM- 7AM- 7AM- 7AM- OFF

4PM 4PM 4PM 4PM 4PM 4PM

MEDTECH 3 8AM- 8AM- 8AM- 8AM- 8AM- 8AM- OFF

5PM 5PM 5PM 5PM 5PM 5PM

MEDTECH 4 7AM- 7AM- 7AM- 7AM- 7AM- 7AM- OFF

4PM 4PM 4PM 4PM 4PM 4PM

PHLEBOTOMIST 7AM- 7AM- 7AM- 7AM- 7AM- 7AM- OFF

4PM 4PM 4PM 4PM 4PM 4PM

LAB 7AM- 7AM- 7AM- 7AM- 7AM- 7AM- OFF

TECHNICIAN 4PM 4PM 4PM 4PM 4PM 4PM

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 PHYSICAL PLANT AND FACILITIES/WORK ENVIRONMENT

1. PROGRAM OF PROPER MAINTENANCE AND MONITORING LABORATORY SITES AND FACILITIES

1.1. The laboratory shall have adequate facility to accommodate efficient operation of tasks required.
There must be a system to provide safety to personnel, environment and security to testing
procedures and records.
1.2. The laboratory site facility must conform to the legal and regulatory requirements of a primary clinical
laboratory. Within premises are area for specimen collection and toilet to afford privacy for urine and
stool collection.
1.3. The laboratory working area will be used for Chemistry, Hematology, and Clinical Microscopy
section. Immunologic testing will be done on either hematology or chemistry section.
1.4. The specimen collection or the extraction area is just outside the working area.
1.5. The site facility shall consider the flow of samples and activities to reflect the logical sequence of
sample reception, test analysis, storage and disposal.
1.6. The work area shall be situated remote and inaccessible to patients and non-laboratory personnel.
Security precautions shall be in place to prevent ready access samples, logbooks, records and
documents, and sensitive equipment and supplies.
1.7. The laboratory shall have adequate electricity, water supply and air conditioning that shall be needed
for provision of efficient and safe operations.
1.8. The laboratory shall maintain clean and orderly at all times. It is the responsibility of the Medical
Technologist to ensure cleanliness of their work area. Maintain the policy “Clean as you go.”
1.9. There shall be adequate lighting and ventilation in all work areas. The lighting and ventilation
requirements shall follow the prescribed building code and DOH infrastructure agency.
1.10. An area shall be designated within the laboratory for personal requirements of personnel.
1.11. No eating or drinking shall be allowed within the working area. Taking of alcoholic beverage and
prohibited drugs shall not be allowed.
1.12. Machines should be periodically inspected for operation within prescribe range. This includes
calibration, temperature regulation, water pressure, etc.

2. PROGRAM FOR PREVENTIVE MAINTENANCE OF THE FACILITY

2.1 General rules and regulations.
2.1.1 The management is responsible for the scheduling the preventive maintenance of the facility.
2.1.2 The management will have accessible contacts to the one responsible to perform the preventive
maintenance of the facility.
2.1.3 Maintenance of records and details of materials/tool/equipment purchased like date of
purchase, manufacturer details, cost of purchase, warranty, dates for part replacement etc.
2.1.4 The one who performed the preventive maintenance will log all the procedures that are done
and signed the preventive maintenance logbook.
2.1.5 Cavite Diagnostic Stroke Care Center Inc., is under the maintenance management of Kooking
Industries (Kll)
2.1.6 The proposed schedule of performing the preventive maintenance for the facility are as follows:

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 EQUIPMENT PREVENTIVE CORRECTIVE PERSON IN
PROCEDURE CALIBRATION MAINTENANCE MEASURE CHARGE
Refrigerator Check Every three (3) Yearly As Needed TRULAB
hemostat and months
temperature

Air-condition Clean the filter Weekly Every six (6) As Needed Aircon
Refill Freon months Maintenance-
KII

Ventilation Clean the filter Every three (3) Yearly As Needed Kll
months

Lighting Change of bulb As Needed Kll

Water Supply Checking of Yearly As Needed Kll

Pump, motor
and valve

2.2 Ventilation:
2.2.1 The purpose of laboratory ventilation systems is to remove contaminants from the air and
thereby ensure that the laboratory is a safe and healthy work environment. Laboratory safety
requirements must be met and will not be compromised to meet other objectives.
2.2.2 Laboratory personnel are tasked to report immediately if there are signs of malfunction.
2.2.3 Thoroughly clean vents and grilles to prevent blockages and improve air circulation. Regularly
replace air filters, as directed by the manufacturer, to maintain efficient air circulation. Regularly
clean and lubricate exhaust fans to prevent dust and grease buildup.
2.3 Lighting
2.3.1 Requirements:
2.3.1.1 Adequate lighting: Laboratories should have 100–200 lumens of lighting.
2.3.1.2 Recessed lighting: Minimizes shadows and provides a consistent light source.
2.3.1.3 Task lighting: Focuses higher lumen output on the work area.
2.3.1.4 Vapor tight fixtures: Withstand exposure to gases, vapors, and moisture.
2.3.1.5 Consistent color temperature: Helps ensure accurate results.
2.3.2 Replace light bulbs immediately, with the proper wattage and type, if it is not working anymore
or is below the required lumen.
2.3.3 Checking the manufacturer’s guidelines can be helpful in scheduling changing of light bulb.
2.3.4 Laboratory personnel are tasked to report immediately if there are signs of malfunction.
2.4 Water Supply
2.4.1 The water supply of the laboratory is maintained by the Kooking Industries,
2.4.2 Laboratory personnel are tasked to report immediately if there are signs of malfunction.
2.4.3 Pumping machinery is mainly subjected to wear, tear, erosion and corrosion. Normally, major
failure and interruptions in water supply system occur due to problems in pumping machinery.
Hence, it is necessary to have timely and effective operation and maintenance of pumping
machinery, up keep of pumping stations and records.
2.4.4 Record maintenance for pumping machinery:
2.4.4.1 Pump operation timings (start and end time daily).
2.4.4.2 Readings of vacuum and pressure gauges.

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 2.4.4.3 Bearing temperature for pump and motor.
2.4.4.4 Water level in intake/sump.

2.4.4.5 Flow meter reading.

2.4.4.6 Any specific problem or event in the pumping installation or pumping system.
2.4.5 Preventive Maintenance of Pumps Monthly/Quarterly Maintenance
2.4.5.1 Clean the pump, motor and other accessories.
2.4.5.2 Check coupling bushes/rubber spider.
2.4.5.3 Check stuffing box, gland etc.
2.4.5.4 Records of pressure, voltage and current.
2.4.5.5 Check and repair of leakage from mechanical seal.
2.4.5.6 Check and repair in case of sparks in motor.
2.4.5.7 Check for free movement of the gland of the stuffing box.
2.4.5.8 Check gland packing and replace if necessary.
2.4.5.9 Clean and apply oil to the gland bolts.
2.4.5.10 Inspect the mechanical seal for wear and replacement, if necessary.
2.4.5.11 Check condition of bearing oil and replace or top up, if necessary.
2.4.6 Six Months Maintenance
2.4.6.1 Verify and rectify alignment of pump and drive.
2.4.6.2 Clean oil lubricated bearings and replenish with fresh oil.
2.4.6.3 Tighten the foundation bolts and holding down bolts of pump and motor mounting on base
plate or frame.
2.4.6.4 Check vibration level with instruments if available; otherwise by observation.
2.4.6.5 Clean flow indicator, other instruments and appurtenances in the pump house.
2.4.7 Yearly Maintenance
2.4.7.1 Clean and flush bearings with kerosene and examine for flaws developed like corrosion,
wear and scratches.
2.4.7.2 Immediately after cleaning, the bearings should be coated with oil or grease to prevent
ingress of dirt or moisture.
2.4.7.3 Clean bearing housing and examine for flaws like wearing, grooving etc. Change oil or
grease in bearing housing.
2.4.7.4 Examine shaft sleeves for wear or scour and necessary rectification. If shaft sleeves are not
used, shaft at gland packings should be examined for wear.
2.4.7.5 Check stuffing box, glands, lantern ring, and mechanical seal and rectify if necessary.
2.4.7.6 Check clearances in wearing ring.
2.4.7.7 Check impeller hubs and vane tips for any pitting or erosion.
2.4.7.8 Check interior of volute, casing and diffuser for pitting, erosion, and rough surface.
2.4.7.9 All vital instruments i.e. pressure gauge, vacuum gauge, ammeter, voltmeter, watt meters,
frequency meter, tachometer, flow meter etc. should be calibrated.
2.4.7.10 Conduct performance test of the pump for discharge, head and efficiency
2.4.8 Maintenance of Motors Monthly/Quarterly Maintenance
2.4.8.1 Clean external surface of motor.
2.4.8.2 Examine earth connections and motor leads.
2.4.8.3 Check temperature of motor and check whether overheated
2.4.8.4 Lubricate bearings
2.4.8.5 Verify and rectify any abnormal noise in bearings
2.4.8.6 Clean belt tension and reduce it where there is excessive tension.
2.4.8.7 Blow dust from the motor.
2.4.9 Six Month Maintenance

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 2.4.9.1 Clean oil lubricated bearings and replenish fresh oil.
2.4.9.2 Wipe brush holders and check contact faces of brushes of slip-ring motors

2.4.9.3 Check insulation resistance of the motor, tightness of cable gland, lug and connecting bolts
2.4.9.4 Check and tighten foundation bolts and bolts holding motor and frame. • Check vibration
level with instrument if available
2.4.9.5 Clean winding of motor, if necessary.
2.4.10 Yearly Maintenance
2.4.10.1 Clean and flush bearings with kerosene and examine for flaws developed, wear and
scratches. Cleaned bearings should be coated with oil or grease.
2.4.10.2 Change oil or grease in bearing housing.
2.4.10.3 Blow out dust from windings of motors thoroughly with clean dry air.
2.4.10.4 Clean and varnish dirty and oily windings
2.4.10.5 Check condition of starter, stamping, insulation, terminal box, fan etc.
2.4.10.6 Check insulation resistance to earth and between phases of motors windings, control
gear and wiring.
2.4.10.7 Check air gaps.
2.4.11 Maintenance of Valves Foot
2.4.11.1 Clean foot valve once in three months.
2.4.11.2 Clean flap of the foot valve once in two months to ensure leak proof operation.
2.4.11.3 Inspect the valve thoroughly once in a year. Check for leakage through foot valve after
priming.
2.4.11.4 Check gland packing once in a month and grease it as per need and change the packing
if needed. It should be ensured.
2.4.11.5 Apply grease to reduction gears thrust bearing once in three months.
2.4.11.6 Check tight closure of the valve once in three months
2.4.11.7 Operate valve once a quarter to full travel.
2.4.11.8 Inspect the valve thoroughly for flaws in guide channel, guide lugs, spindle, spindle nut,
stuffing box etc. once in a year. Reflux (non-return) valve
2.4.11.9 Check proper operation of hinged door and tight closure under no-flow condition once in
3 months.
2.4.11.10 The valve shall be thoroughly inspected annually.
2.4.11.11 Condition of dampening arrangement should be thoroughly examined once in year and
necessary maintenance and rectification should be carried out as per manufacturer’s
instruction.
2.4.11.12 In case of dampening arrangement, check for oil leakage and replace oil once in a year.
Butterfly valve
2.4.11.13 Check seal ring and tight shut-off once in three months.
2.4.11.14 Lubricate gearing arrangement and bearing once in three months.
2.4.11.15 Inspect the valve thoroughly including complete operations once in a year.
2.4.11.16 Change oil or grease in gearing arrangement once in a year.
2.4.12 Maintenance of Electrical Components (Starters, Breakers, Panel etc.)
2.4.12.1 Clean the external surface and check for spark or leakage current and overheating on
daily basis.
2.4.12.2 Clean internal components and blow dust, and tighten all connections monthly.
2.4.12.3 Check all the connections as per circuit diagram, condition of oil in oil tank and its
replacement if needed, check condition of resistance and insulators once in three months.
2.4.12.4 Servicing of all components; cleaning and reassembly and calibration of voltmeter,
ammeter, and frequency meter on annual basis.

Page | 19
3. GUIDELINES ON LABORATORY BIOSAFETY AND BIOSECURITY
3.1 Security and Safety in the Laboratory should be the responsibility of all personnel. Procedures should
be adopted to maintain the security and the integrity of the biological samples, documents and other
records and more importantly the safety in the working environment of its employees.
3.2 The laboratory manager shall be designated as the safety and security officer of the laboratory who
shall oversee, implement and monitor all its general activities.

3.3 Laboratory Security and Practice

3.3.1 A laboratory must control access of unauthorized individual and ensure that no unauthorized
individual can gain access directly to specimens, aliquots and records.
3.3.2 The patient’s relative or companion shall be limited to the extraction/reception area. Only one
(1) companion per patient is allowed.
3.3.3 Only authorized visitors can enter the offices within the laboratory. However, they are not
allowed to interfere with analytical procedures. Exceptions to these ruling are equipment
engineers, product specialists who maintain/ repair equipment and conduct product
demonstrations.
3.3.4 Cleaners, Engineering and maintenance personnel may enter the analytical work areas and
pathology offices provided that specified work has been requested and provision foe escort has
been accorded.
3.3.5 All records, logbooks, documents, files shall not be taken out of the laboratory premises without
the approval of the head of the laboratory. Copies of laboratory results/reports may be secured
by the patient’s authorized representative.
3.3.6 All equipment must be used as only as per the instructions. Any equipment with moving parts,
must be handle and use with care and caution.
3.3.7 Keep the facility clean and clutter free.
3.3.8 Observe “universal precautions” when collecting, processing, storing, shipping or transporting
human blood and body fluids.
3.3.9 Wash hands after handling infectious material (even when gloves have been worn) and before
leaving the laboratory.
3.3.10 Sharps must be handled carefully and disposed in a puncture-proof container.
3.3.11 Mouth pipetting is not allowed.
3.3.12 Minimize generation of splashes and aerosols.
3.3.13 Eating and drinking in the laboratory is prohibited.
3.3.14 Decontaminate all contaminated materials before disposal or reuse.
3.3.15 Decontaminate laboratory surfaces following any spill of bio-hazardous materials and at the end
and start of each working day.
3.3.16 Report all spills and accidents/incidents.
3.3.17 Spills shall be cleaned using the spill kit provided by the laboratory. Personnel cleaning the spill
should be in proper PPE uniform for safety.
3.3.18 In case of fire due to chemicals it is advised that all laboratory personnel must exit the
laboratory immediately. Usage of fire extinguisher is a must, provided that the personnel had
undergone training with the Bureau of Fire Protection.

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3.4 Laboratory Facility
3.4.1 Ventilation system should have directional airflow from the corridor into the laboratory suite.
3.4.2 Work surfaces should be resistant to water and easy to clean and disinfect.
3.4.3 Shall have readily available hand washing facilities.
3.4.4 The laboratory is equipped with water sprinkler and fire alarm.

3.5 PPE or Safety Equipment

3.5.1 Laboratory personnel must wear the uniform provided by the company with the long-sleeve
laboratory gown.
3.5.2 Always wear gloves whenever handling specimens and reagents, and during blood extraction.
3.5.3 Restrain long hair, avoid loose clothing or jewelry and open-toed shoes.
3.5.4 Remove all PPE when contaminated before re-use or disposal.
3.5.5 Use the sterilization room for any laboratory procedures that may give rise to infectious agents.
3.5.6 The need to use PPE shall be determined from the process of hazard identification, risk
assessment and development of risk control measures.
3.5.7 PPE shall conform to any standard of the Department of Health.
3.5.8 Full-body protection
3.5.8.1 Where there is risk of dermal exposure to specific infection agents or hazardous chemicals
3.5.9 Eye Protection/face shield
3.5.9.1 Where risk of eye injury. Typical hazards might include flying particles, dust, splashing
substances, harmful gas, vapors, aerosols, and high intensity radiation.
3.5.10 Respiratory Protection
3.5.10.1 Where all other practicable measure has been taken to provide control measures to
ensure that no staff member is exposed to an atmosphere that is or may be injurious to
health.
3.5.11 Hand Protection
3.5.11.1 Where there is an identified hazard with a potential for hand injury, transmission of
infection or adsorption of substances via the skin.
3.5.12 Protective foot wear
3.5.12.1 Safety footwear shall be provided where the nature of the work exposes the employee to
a medium to high-risk injury to feet for example.

3.6 Occupational Health

3.6.1 Staffs are advised to receive vaccination according to the degree of exposure.
3.6.2 Staff should have medical benefits or insurance for their health protection.
3.6.3 Any incidents, i.e., eye splash, accidental puncture, must be reported and documented. Any
necessary tests to ensure the laboratory staff after the incident must be made and shouldered
by the company.

3.7 Housekeeping Protocols:

3.7.1 Cleaning with facility approved disinfection and water.
3.7.1.1 In the basin, prepare the correct dilution of the facility approved disinfectant.
3.7.1.2 Using one clean rag, clean all the surfaces in the room, pay special attention to surface
when it comes in contact with hands.
3.7.1.3 Next, to clean the bathroom, change gloves and clean the bathroom in the usual manner.
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 3.7.1.4 After cleaning the toilet, discard the facility approved disinfectant and water from the basin,
into the toilet flush.

3.7.1.5 Rinse the basin with hot water.

3.7.1.6 Change gloves again.
3.7.2 Wiping the facility approved disinfectant
3.7.2.1 Wear gloves and start in the extraction area, spray all the flat surface with facility approved
disinfectant and another clean rag, and wipe all the surfaces.
3.7.2.2 After wiping all the surfaces in the room, change gloves.
3.7.3 Washing the floor
3.7.3.1 Dry mop the floor
3.7.3.2 Prepare a fresh solution on facility approved disinfectant and water in a bucket to clean the
floor.
3.7.3.3 Wash the floor with the clean mop head as per routine.
3.7.3.4 After the floor is washed, pour the water into the toilet and flush.
3.7.3.5 Place the mop heads and rags into a clean plastic bag to be returned in housekeeping, keep
all other equipment in the room.
3.7.3.6 Remove outer gloves, then gown and finally the last pair of gloves.
3.7.3.7 Wash hands for thirty (30) seconds.
3.7.3.8 Leave the room and when outside rub alcohol-based hand rinse agent to hands.

3.8 PEST AND VERMIN CONTROL PROGRAM

3.8.1 Facility Manager
3.8.1.1 The facility should be informed of all pest activities sighted by other occupant or pest control
vendors. If the facility manager believes the pest problem is not being resolved or wants
additional pest control service, request for assistance should be done.
3.8.2 Best Management Practices for Pest Control
3.8.2.1 Pest monitor traps. All pest monitor traps must be labeled with a date and placed in a
location or record. The record can be either a map or else documented on a service report
form.
3.8.2.2 Service report form. There forms documented the report of a pest problem, actions taken to
correct the problem and findings relevant to the source of the infestation.
3.8.2.3 A pest control technician will fill out a service report form on each visit to the facility all
service report forms will be kept in a logbook on location.
3.8.3 Pest monitoring
3.8.3.1 Insects and rodent survey traps will be placed in potential pest hiding locations and checked
monthly for the presence of pests. The Presence of pests will be reported on the service
report form. The commercial pest control technician will document all control actions taken
and findings on the same service report form. When traps are no longer effective, they will
be replaced as needed.

4. LABORATORY SAFETY AND PRECAUTION

4.1 CHEMICAL HAZARDS
4.1.1 Use with extreme caution reagents which are strong acids and strong base. Avoid splashes,
spills, and eye and skin contacts. Do not inhale fumes.
4.1.2 Any chemical which contacts the skin and eyes should immediately be washed with running
water for approximately five (5) minutes unless the label says otherwise. The laboratory has an
emergency eyewash and shower area.

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 4.1.3 Read all labels for precautions on handling and emergency management of potential hazards of
reagents.

4.1.4 In case of emergency/accidents, refer the problem to the Pathologist for proper handling and
treatment.
4.1.5 Chemicals should be disposed properly in accordance with the manufacturer’s instructions.
However, directions which are explicitly provided in the label as to disposal should be followed.
4.1.6 Mouth pipetting should no longer practices to avoid aspirating or ingestion through the mouth.

4.2 BIOLOGICAL HAZARDS

4.2.1 All specimen is potentially infectious and should be handled with extreme care.
4.2.2 Laboratory coat/gown should be worn at all times to avoid contamination.
4.2.3 The following specimens should be handled with extreme caution:
4.2.3.1 All specimens
4.2.3.2 Serologic specimens
4.2.3.3 Icteric blood/serum/plasma
4.2.3.4 If requests state history of possible: HIV-AIDS, typhoid fever, hepatitis, syphilis,
meningococcemia, and Encephalitis.
4.2.3.5 All specimens with requests attached as potentially highly infectious material labeled with
“BIOLOGICAL HAZARD-HANDLE WITH EXTREME CARE”
4.2.4 Specimens at letter C shall be labeled with “BIOLOGICAL HAZARD”
4.2.5 Biological specimen and any contaminated articles like lancets, needles, syringes and highly
infected specimen vials should be disposed of or placed in biohazard bags of containers,
soaked in decontaminating solution before disposal.

4.3 FIRE HAZARD

4.3.1 Local regulations in fire safety, including the storage of flammable solvents and reactive
chemicals, the provision of suitable fire-fighting equipment, and designation of laboratory fire
safety officers and scheduled of fire drills must be given a due regard.
4.3.2 A fire extinguisher is logically located near the laboratory and more around the facility.

5. WASTE MANGEMENT PRACTICE

5.1 All medical and administrative personnel are imposed to practice proper waste segregation and
disposal of waste.
5.2 Persons involved:
5.2.1 All laboratory personnel
5.2.2 Pollution control officer

5.3 DETAILS OF HAZARDOUS HEALTH CARE WASTE

5.3.1 INFECTIOUS/ PATHOLOGICAL WASTE, INCLUDING SHARPS AND NEEDLES
5.3.1.1 Infectious waste are solid and liquid wastes that may contain pathogenic organisms that can
be transmitted thru puncture, abrasion, cut in the skin, mucous membrane, inhalation, and
ingestion.
5.3.1.2 Sharps including syringes should all be collected and placed in a puncture-proof container,
fitted with cover. The sharps shall be pre-treated with chemical disinfectants.
5.3.1.3 The puncture-proof containers shall be segregated and placed in a red color-coded plastic
garbage bag marked with “CAUTION: BIOHAZARD WASTE”

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 5.3.1.4 All urine specimens and other residual of general healthcare waste for disposal shall join the
stream of domestic refuse or municipal solid waste.

5.3.2 CHEMICAL WASTE INCLUDING WASTE WITH HIGH CONTENT OR HEAVY METALS
5.3.2.1 These are discarded solid, liquid gaseous chemical materials and products that may cause
intoxication, either by acute or chronic exposure, injuries including burns. Routine of entry
may be absorption thru skin, mucous membranes, eyes, or direct contact with their
genotoxic, flammable, corrosive, or reactive properties.
5.3.2.2 All chemical waste shall be classified packed in chemical resistant containers and sent to a
specialized treatment facility (if available). The identity of the chemicals shall be clearly
marked on the containers. Hazardous chemical waste of different types should never be
mixed.
5.3.2.3 Waste with high content of heavy metals should be collected separately. These may be sent
to treatment facilities.
5.3.2.4 All chemical waste shall be segregated and placed in a yellow plastic garbage bag with
black band and appropriate markings.

5.3.3 PRESSURIZEED CONTAINERS

5.3.3.1 Gas stored pressurized containers, aerosols, cylinders used in analytical testing once empty
may be reusable, but certain types may be disposed of.
5.3.3.2 All pressurized containers may be collected with general health care waste once they are
completely empty.
5.3.3.3 Aerosol containers shall not be burned or incinerated

5.3.4 ON- HAZARDOUS HEALTH CARE WASTE

5.3.4.1 GENERAL WASTE
5.3.4.1.1 These are waste comparable to domestic waste that do not pose any harm or
hazard to human health or environment. They are derived to human health or
environment. They are derived mostly from administrative and housekeeping
functions.
5.3.4.1.2 The laboratory shall practice waste minimization by applying various methods;
waste-reduction at source, re-use, recycle, waste segregation, composting.
5.3.4.2 BIODEGRADABLE WASTE
5.3.4.2.1 Use of sanitary landfill
5.3.4.2.2 Composting
5.3.4.2.3 Where a municipal of city collection system is available
5.3.4.3 NON-BIODEGRADABLE WASTE
5.3.4.3.1 Recycle, re-use of: glass, metals, plastics, computer, cartridges and other.

5.4 WASTE HANDLING, STORAGE AND TRANSPORT

5.4.1 SEGRAGATION:
5.4.1.1 Segregation at the point of waste generation for classification and bagging in appropriate
waste disposal bags or containers shall be done by the medical technologist or authorized
laboratory personnel.
5.4.1.2 Waste containers must be designed to maintain its integrity throughout handling, storage,
transportation and treatment.

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 5.4.1.3 Separation of hazardous waste by color-coding of disposal bag/containers will prevent
accidents or unnecessary exposure to infectious waste and will facilitate waste disposal. As
prescribed by the DOH Environmental Health Service for Hospital/Health Facility Waste
Management, the color-coding shall be as follows:

COLOR OF CONTAINER AND TYPE OF CONTAINER TYPE OF WASTE

MARKINGS

Yellow, marked “HIGHLY Strong, leak- proof plastic bag, or Highly infectious waste
INFECTIOUS” container capable of being
autoclaved

Yellow Leak-proof plastic bag or Other infectious waste,

container pathological and anatomical waste

Yellow, marked “SHARPS” Puncture-proof container Sharps

Brown Plastic bag or container Chemical and pharmaceutical

waste

ANY COLOR Lead box, labeled with the Radioactive waste

radioactive symbol

Black Plastic bag Non – Infectious Dry Waste

Green Plastic bag Non- Infectious Wet Waste

5.4.1.4 General health care waste should join the stream of domestic refuse for disposal.
5.4.1.5 Sharps should be collected all together whether they are contaminated or not in puncture-
proof container with disinfectant.
5.4.1.6 Bags and containers for infectious waste should be marked with the international infectious
waste should be marked with the international substance symbol.
5.4.1.7 Highly infectious waste should, whenever possible, be sterilized immediately by autoclaving.
It therefore needs to be packed in a bag that is compatible with the proposed treatment
process, red bags, are suitable for autoclaving, and are recommended.
5.4.1.8 Staff should never attempt to correct errors of segregation by removing items from a bag or
container after disposal or by placing a bag inside another bag of a different color.
5.4.1.9 In accordance to RA 6969

5.5 ON SITE COLLECTION, TRANSPORT AND STORAGE

5.5.1 Clinical staff should ensure that waste bags are tightly closed when they are about three
quarters full.
5.5.2 Bags should not be closed by stapling.
5.5.3 Sharp containers should be placed in a yellow-labeled bags before removing inside the
laboratory.
5.5.4 Wastes should be collected daily and transported to the central collecting site.
5.5.5 A supply of fresh bags should always be readily available at the site of waste generation.
5.6 STORAGE
5.6.1 A storage area is designed inside the health care facility.
5.6.2 Criteria of storage area:
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 5.6.2.1 Should have impermeable, hard standing floor.
5.6.2.2 With water supply for easy cleaning
5.6.2.3 It should be possible to lock to avoid unauthorized access
5.6.2.4 Should not be located in the proximity of foods or drinks
5.6.2.5 Should have good lighting and least passive ventilation.

6. WASTE MANAGEMENT DISPOSAL

6.1 SHARPS:
6.1.1 All needles, specimen slides and cover slips are discarded in a puncture proof sharps container
– yellow bag.
6.2 BLOOD SAMPLE:
6.2.1 All collected blood sample will be kept in refrigerator for seven days before disposal.
6.2.2 Specimen will be discarded in a puncture proof container – yellow bag.
6.3 URINE:
6.3.1 Urine specimen will be stored up to four (4) hours from time of collection.
6.3.2 At the end of the shift urine will be per-treated with 1% sodium hypochlorite. Therefore a 1:5
dilution, for at least 30 mins before discarding into the sink with running water.
6.3.3 Urine containers are discarded at the infectious waste – Yellow bag.
6.4 STOOL:
6.4.1 Stool sample can only be stored up to one hour after collection.
6.4.2 Stool sample is discarded in the infectious waste – yellow bag.
6.5 NON-INFECTIOUS – DRY WASTE
6.5.1 Non-infectious Dry waste, are placed in a black plastic bag.
6.6 NON-INFECTIOUS – WET WASTE
6.6.1 Non- infectious Wet waste, are placed in the green plastic bag.
ALL LABORATORY SEGREGATED INFECTIOUS WASTES AND BIOLOGICAL WASTES ARE
COLLECTED FROM THE LABORATORY BY THE BUILDING UTILITY. PICK UP AND DISPOSAL OF
WASTES IS DONE BY AN AUTHORIZED HAULER (CLEAN HAUL ENVIRONMENTAL SERVICE INC.)

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 GOOD LABORATORY PRACTICE
1. PERSONAL AND GENERAL LABORATORY SAFETY
1.1 Never eat, drink, or smoke while working in the laboratory.
1.2 Read labels carefully.
1.3 Do not use any equipment unless you are trained and approved as a user by your supervisor.
1.4 Wear safety goggles or face shield when working with hazardous materials and/or equipment.
1.5 Always wear gloves when processing specimen especially when using any hazardous or toxic agent.
1.6 Clothing: When handling dangerous substances, wear gloves, laboratory gown or full-body PPE, safety
goggles or face shield, and face mask. Shorts and sandals are not allowed should not be worn in the
laboratory at any time. Shoes are required when working in the laboratory.
1.7 If you have long hair or loose clothes, make sure it is tied back and confined.
1.8 Keep the work area clear of all materials except those needed for your work. Coats should be hung in
the hall or placed in the locker. Books, purses, bags and other miscellaneous items that does not
correlate with the processing in the laboratory should be kept away from the working area and the
equipment.
1.9 Disposal, the staffs are responsible for the proper disposal of used material, and contaminated
materials in their appropriate color-coded plastic bag and trash bin.
1.10 Equipment failure, if a equipment fails while being used, report it immediately to you immediate
supervisor. Never try to fix the problem especially if the failure is due to mechanical parts.
1.11 If the laboratory will be unattended, turn off all ignition sources, pull-out all plug/socket and lock
the door access to the laboratory.
1.12 Never pipette by mouth.
1.13 Clean up your work area before leaving.
1.14 Wash hands before leaving the laboratory and before eating.

2. CHEMICAL SAFETY
2.1 Treat all chemical and reagents as hazardous materials.
2.2 Make sure all chemicals are clearly and currently labeled with the substance name, concentration,
expiration date, lot number, and manufacturer,
2.3 Comply with the fire regulations concerning storage quantities, types of approved containers and
cabinets, proper labeling, etc. If uncertain about regulations, contact the building coordinator.
2.4 Use volatile and flammable compounds in an open area, it is preferable to use under a fume hood, if
available.
2.5 Avoid skin contact with any solvent or chemical.
2.6 It is highly discouraged to smell any solvent.
2.7 Dispose of waste and broken glassware in proper containers.

3. ELECTRICAL SAFETY
3.1 Obtain permission before operating any high voltage equipment.
3.2 Maintain an unobstructed access to all electrical panels.
3.3 Wiring or other electrical modifications must be referred to the electronic shop of the building
coordinator.

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 3.4 Avoid using extension cords. If there is a need to use one, it is highly advised to use a heavy-duty type
that is electrically grounded, and has its own fuse.
3.5 Never modify, attach or otherwise change any voltage equipment.
3.6 Always turn off the machines if you need to touch the inside.
3.7 Clean up spills immediately
3.8 Do not store food in the laboratory and refrigerators.

EQUIPMENTS
1. LIST OF LABORATORY EQUIPMENT
1.1 Clinical Chemistry Analyzer ( AMS Diagnostics Liasys 330)
1.2 Clinical Chemistry Analyzer (EMP 168)
1.3 Hematology Analyzer (Dymind DF50)
1.4 Serology (Wondfo – Finecare FIA and Tisenc ACCRE CLIA)
1.5 Coagulation Studies (Wondfo)
1.6 Binocular Microscope
1.7 Clinical Centrifuge 6 Placer
1.8 Hematocrit Centrifuge 12 placer
1.9 Pipettes ( 2pcs. 100-100uL, 1pc. 10-100uL, 1pc. 5-50uL, 1pc. 20-200uL)

2. PROGRAM FOR CALIBRATION, PREVENTIVE MAINTENANCE AND REPAIR OF EQUIPMENTS

2.1 The laboratory equipment should be calibrated at least once every six (6) months.
2.2 The medical technologist shall make a request for calibration every six (6) months thru the laboratory
manager.
2.3 The medical technologist on duty shall follow all written procedures so as to prevent the untimely
breakdown of equipment.
2.4 If the machine/equipment breaks down, the medical technologist on duty shall inform immediately the
administrator for immediate action.
2.5 The equipment, maintenance and repair record must be documented that all instruments are properly
maintained, calibrated, cleaned and monitored. Including the corrective measures and recommendation
done.
2.6 Any discrepancy in the calibration is addressed and corrective measures are taken to ensure quality of
results released by the laboratory.
2.7 The medical technologist shall be responsible for coordinating with the technician and engineers for
immediate calibration without considering its regular calibration schedule.
2.8 Equipment for preventive maintenance are recorded bearing the date of maintenance, and equipment’s
serial number and the technician/engineer’s name who handled the maintenance.
2.9 Status of maintenance is kept in a logbook for reference.
2.10 The chief medical technologist is responsible for keeping an updated maintenance work of the
equipment by calling the technician at a regular schedule
2.11 Any equipment in the laboratory that needs repair is given an utmost attention,
2.12 Technician are called to handle repairs.
2.13 Any equipment that cannot be repaired is immediately taken out of the laboratory and emergency
purchase of the equipment shall be made.

3. EQUIPMENT DESIGN
3.1 Use only properly designed equipment that is capable of fulfilling its functions, as detailed in the
experimental protocol, including the equipment used for the generation, measurement, or assessment
of data, as well as that used to regulate the environment of the testing facility. Keep equipment
accessible and suitably located for proper operation, inspection, cleaning and maintenance. Identify all

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 equipment with a unique number, such as inventory number, for correlation with the calibration,
maintenance and repair record.

4. DOCUMENTATION
4.1 Maintain written records of all inspection, maintenance, testing, calibration, and/or standardizing
operations in equipment logs. Maintain equipment logs for all laboratory field equipment, including
centrifuges, freezers, microscope, autoclaves, generators, etc. Equipment used in the laboratory.
Clearly identify the log by equipment, name and dates covered. Include the following information in the
log:
4.1.1 Dates and equipment is in operation
4.1.2 Dates and result of inspection.
4.1.3 Maintenance, including cleaning procedures. Describe whether maintenance was routine and
followed written standard operating procedures.
4.1.4 Testing, calibration, and/or standardization operations.
4.1.5 Service and repair events. Record the nature of failure or malfunction, how and when it was
discovered, and any remedial action taken.
4.1.6 Changes in configuration and addition of options.
4.2 Store all written records or equipment logs in the archives when they are no longer kept in the
laboratory or field station each log should be adequately identified as to the piece of equipment and
dates covered by the log.
5. CONTINGENCY PLAN IN CASE OF EQUIPMENT BREAKDOWN
5.1 Laboratory staff should be well aware of manual methods in case of equipment breakdown.
5.2 Report equipment breakdown to the owner of the company or if the owner is not present, notify the
administrative staff.
5.3 If he machine breaks down, the medical technologist on duty will contact the supplier to provide a
backup machine.
5.4 If the supplier cannot provide an immediate back up machines, the medical technologist on duty will do
the manual procedure for STAT specimens.
5.5 After the STAT procedure, the medical technologist on duty will do basic troubleshooting, if the
machine is still not properly functioning, the medical technologist will contact the supplier and try
troubleshooting through the instructions relayed by the supplier by the phone. If the problem persist,
an incident report address to the head of the laboratory, and the head of the laboratory will coordinate
with the operational manager to do an action.
5.6 All machines are provided with UPS. The UPS must be charge all the time for the operation to be
continue in case of power outage.
5.7 All specimen request for the day will be sent to an affiliated/accredited laboratory.
5.8 Laboratory examinations that are beyond the capability of the laboratory are sent out to an
affiliated/accredited laboratory. Results are expected the next day unless stated otherwise.
5.9 In cases, where the medical technologist on duty is absent, adjustment on schedule should be made
with the permission of the chief medical technologist and the operations manager/ clinic administrator.
5.10 Emergency services: whom to contact, the telephone numbers and addresses of the following
should be prominently displayed in the facility:
5.10.1 The institution or laboratory itself (the address and location may not be known in detail by the
caller on the services called)

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 5.10.2 Operations manager/clinic administrator
5.10.3 Head of the Laboratory
5.10.4 Bio-safety Officer
5.10.5 Fire Officers
5.11 To avoid events of equipment malfunction, laboratory staff shall strictly follow the calibration and
maintenance procedures, adequately inspect, clean and maintain all equipment before each use.

REAGENT AND SUPPLIES

1. QUALITY OF RECORD
1.1 The clinic shall have an adequate supply of properly stored and inventoried supplies and reagents for
the examinations provided.
1.2 Supplies, reagents and material with soonest expiration dates must be utilized first. Expiration dates
shall be strictly monitored to avoid materials, supplies and reagents wastage/spoilage. The Medical
Technologist assigned in a section is responsible for monitoring each supply in his/her section and shall
report to the chief medical technologist in requesting supplies of the section with the requisition Form.

2. QUALITY CONTROL OF REAGENTS

2.1 Labels and inserts shall be read and followed prior to the preparation of reagents.
2.2 When prepared in-house, the reagent’s label must contain the following information:
2.2.1 Name of the solution
2.2.2 Date of preparation
2.2.3 Expiration Date
2.2.4 Storage Temperature
2.2.5 Initials of persons preparing the solution
2.3 Each run must include one full set of controls. Quality control specimens are run daily prior to the run of
the analytical procedure unless otherwise stated.
2.4 The controls for each test run must yield within the limits of the manufacturer’s criteria for acceptability
and validity of the run.
2.5 Reagents, calibrators and controls are stored and handled according to the directions specified by the
manufacturer.
2.6 All test kits must be used before the expiration date to ensure valid results.
2.7 Physical parameters of the test such as incubation time and temperature must be followed to ensure
proper performance.
2.8 Proper pipetting procedures shall be strictly observed to avoid variation in the volume of reagents or
specimens during transferring.

3. TEMPERATURE MONITORING
3.1 Refrigerator used for reagents storage in laboratory must be labeled with words to effect of: “NO
FOOD ALLOWED.” The refrigerator in the laboratory is meant for the reagent’s storage and/or any
chemicals needed in different test procedures that requires refrigeration.
3.2 Proper monitoring of the laboratory refrigerator must be log in the monitoring sheet.

4. MATERIAL SAFETY DATA SHEET

4.1 The supplier will provide the Material Safety Data Sheet in all Reagents used in the laboratory.
4.2 The chief medical technologist will make a compilation of all the material safety data sheet, which is
always available when needed.

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 POLICY ON SECURITY OF SUPPLIES AND SPECIMEN
1. SECURITY OF SUPPLIES
1.1 The laboratory ensures that the procedures for the purchase, receipt, and storage of all reagents,
guarantee that the quality of testing is not compromised.
1.2 All new lots of reagents are crosschecked and documented with previous lots to ensure
reproducibility. Environmental conditions for the storage of all reagents and consumables are
monitored and documented.
1.3 The laboratory maintains record of all laboratory supplies, including reagents and consumables, this
information includes:
1.3.1 Identity of the reagent consumables
1.3.2 Manufacturer’s name
1.3.3 Contact information for the supplier or the manufacturer
1.3.4 Date of receiving and date of entering into service
1.3.5 Condition when received.
1.3.6 Manufacturer’s instructions
1.3.7 Records that confirm the reagents or consumables initial acceptance for used
1.3.8 Performance records that confirm the reagents or consumables ongoing acceptance for use.
1.4 Store all supplies, controls, and reagents according to the manufacturer’s recommendations.
1.5 Store supplies controls and reagents in designated storage areas of the laboratory (e.g., chemistry
refrigerator, chemistry freezer). Generally, items are stored nearest to their point of usage.
1.6 Always rotate stock by putting the newest item or the longest expiration dates in the back of the
oldest items or the shortest expiration dates, to the front of the refrigerator or cabinet.
1.7 Check the expiration dates on all items each time they are used to ensure their stability according to
the prescribed specification, unless otherwise specified, do not use supplies, controls, and reagents
past the manufacturers stated expiration date.
1.8 Safely discard supplies, controls and reagents once they became outdated and expired.

2. SECURITY OF SPECIMEN
2.1 Specimen Receiving and Recording
2.1.1 All specimen from out-patients must be received in the designated receiving area of the
laboratory.
2.1.2 Laboratory hours for out-patient is from 6:00 AM to 3:00 PM, Monday to Saturday.
2.1.3 Laboratory request forms should be completely filled-out specifying the examination desired
and the name of the requesting physician.
2.1.4 The patient’s data must be recorded in the Entry/Receiving Logbook and Send-out log book
for sent-out procedures.
2.2 Specimen Collection, Handling, Processing and Storage
2.2.1 Clinical Chemistry, Immunology & Serology
2.2.1.1 Specimen Collection
2.2.1.1.1 Collection of specimen involves its proper techniques and transport of the
specimen to the laboratory and the proper identification of specimen.
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 2.2.1.1.2 All specimens submitted must be of sufficient quantity, fresh and free from
hemolysis (serum sample) and should be accompanied by a completely filled-up
laboratory request.

2.2.1.1.3 The patient is asked of fasting hours for tests like fasting blood sugar, lipid profile
and oral glucose tolerance test. The phlebotomist must note the fasting hours of
the patient in its request. The laboratory will accept over-fasting patients of they
insist, however they will be notified that the hour of fasting will be reflected on
their result. The following are the hours of fasting per test:
2.2.1.1.3.1 FBS = 6-8 hours
2.2.1.1.3.2 OGTT = 6-8 hours
2.2.1.1.3.3 Total cholesterol, HDL, LDL, VLDL = 10-12 hours
2.2.1.1.3.4 Triglycerides = 10-12 hours
2.2.1.1.3.5 Lipid profile = 10-12 hours
2.2.1.1.3.6 FBS and Lipid profile = 10 Hours

2.2.1.2 Specimen Handling

2.2.1.2.1 The handling of specimens must be in compliance with the regulations regarding
laboratory safety of this manual. This includes, but is not limited to, the use of
gloves, protective lab coats, protective pipetting shield, protective eye wear, and
face shields, as appropriate for the task being performed.
2.2.1.2.2 Handwritten label, or pre-printed labels are to be affixed to sample tubes
(vacutainers, capillary tubes or syringes) immediately after the specimen has
been obtained.
2.2.1.2.3 Tubes should be handled gently and kept in a stable vertical position after
collection to promote better clot formation and to prevent hemolysis.
2.2.1.2.4 Red tops are allowed to clot for 15- 30 minutes at room temperature. Do not
release the clot by rimming the tube with an applicator stick prior to
centrifugation.
2.2.1.2.5 Samples are to be centrifuged within 30 minutes of receipt unless constituent’s
stability is such that more rapid processing is indicated. Serum maybe separated
from the cells by decantation or aspiration. If delays in testing are anticipated, the
sample should be refrigerated or frozen, depending on constituent stability.
2.2.1.2.6 Tubes should be placed into the centrifuge in a pattern designed to balance the
centrifuge head. The same sized tubes should be placed exactly opposite each
other. If an odd number of specimens are to be processed, tube filled with water
should be used for balance.
2.2.1.2.7 Tubes are centrifuges with stoppers in place or with an adequate closure. Serum
tubes are spun for ten (10) minutes and plasma tubes are spun for ten (15)
minutes.
2.2.1.2.8 Separate the serum/plasma using the pipette, immediately after centrifuging.

2.2.1.3 Specimen Storage

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 2.2.1.3.1 Tubes should remain sealed when not in use. Tests which cannot be run
immediately are to be aliquoted (if necessary) labelled, and stored at refrigerator
or freezer temperature according to the storage directions.
2.2.1.3.2 If specimen is stored in frozen state (0° to 20°c for 7 days), it must be thoroughly
thawed and re-centrifuged before processing.

2.2.2 Hematology
2.2.2.1 Specimen Collection and Handling
2.2.2.1.1 Collection of specimen involves proper technique, transport and proper
identification.
2.2.2.1.2 All specimens submitted must be of sufficient quantity (proper blood and
anticoagulant ratio), fresh and free from hemolysis, and accompanied by a
completely filled-up laboratory request form.
2.2.2.2 Specimen Storage
2.2.2.2.1 EDTA tubes for hematology are stored in 2° - 8°c for up to seven (7) days.
2.2.2.2.2 Blue top or citrated tubes for coagulation studies storage depends on the
temperature maintained during transport and storage: 22°-24°C = 2 hours; 2°-
4°C = 4 hours

2.2.3 Clinical Microscopy

2.2.3.1 Specimen Collection and Handling
2.2.3.1.1 Specimen brought into the laboratory should be accompanied by a laboratory
request, which contains the patient’s name, age, gender, date and time of
collection, type of specimen, procedure requested and name of the requesting
physician.
2.2.3.1.2 Random and early morning urine specimen should be freshly voided into a sterile
container.
2.2.3.1.3 Early morning midstream urine is preferred and should not be mixed with night
time urine.
2.2.3.1.4 Urine specimen should not be less than 15cc, except in cases of oliguria when
difficulty of urinating, is to be considered. In such case, volume should be
reported.
2.2.3.1.5 Stool should be pea-size specimen and free of contamination of water and urine,
placed in a clean and sterile receptacle.
2.2.3.2 Specimen Storage
2.2.3.2.1 Tests which cannot be run immediately are to be stored in a 2°-8°C for 2 hours.

2.3 Criteria for Adequacy or Inadequacy of Specimens

2.3.1 Urine
2.3.1.1 At least 3mL of sample is required.
2.3.1.2 Specimen Required: 15-20cc of midstream urine, early morning or random urine, freshly
voided into sterilized container. It should be submitted within one (1) hour after
collection.
2.3.1.3 Five (5) to ten (10) cc of freshly voided urine for pregnancy test.
2.3.2 Stool

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 2.3.2.1 Pea-size specimen
2.3.2.2 Watery stool should be submitted within thirty (30) minutes after collection and formed
stool within one (1) hour.
2.3.3 Blood
2.3.3.1 Three(3) to five(5) mL for routine chemistry
2.3.3.2 Five(5) mL for routine chemistry and send-out examinations
2.3.3.3 One (1) to two(2) mL for CBC
2.3.3.4 One point eight (1.8) mL for Citrated blood for coagulation studies
2.3.3.5 Two(2) mL of EDTA for ESR

2.4 Criteria for Specimen Rejection

2.4.1 Unacceptable specimens are reported immediately.
2.4.2 Specimens that does not meet the criteria for specimen requirements.
2.4.3 Mislabeled Specimen
2.4.3.1 The name and/or identifying number do not match on the sample and requisition.
2.4.3.2 The name and/or identifying number are missing from the sample requisition.
2.4.4 Unsuitable Specimens
2.4.4.1 Specimens received from unknown clinics or persons are rejected. Only laboratory staffs
of the company are allowed to extract blood from patients.
2.4.4.2 Specimens received in leaking or unsealed containers are not acceptable.
2.4.4.3 Quantity not sufficient (QNS) specimen.
2.4.4.4 Markedly hemolyzed specimen
2.4.4.5 Improperly collected specimen
2.4.4.6 Inappropriate type of specimen
2.4.4.7 Unacceptable time lapse since collection
2.4.4.8 Specimens not collected in the proper container
2.4.4.9 Improperly handled specimens
2.4.5 Blood
2.4.5.1 Hemolyzed serum
2.4.5.2 Insufficient amount if blood extracted
2.4.5.3 Prolong standing of specimen especially for blood chemistry.
2.4.5.4 Improperly labeled specimen
2.4.5.5 Incomplete patient’s data and request
2.4.5.6 Wrong blood to anticoagulant ratio.
2.4.6 Urine
2.4.6.1 Heavily turbid urine for pregnancy test
2.4.6.2 Two (2) hours old urine specimen
2.4.6.3 QNS specimen
2.4.6.4 Improperly labeled specimen
2.4.6.5 Specimen from outside must be transported following proper procedures.
2.4.6.6 Incomplete patient’s data.
2.4.7 Stool
2.4.7.1 Stool contaminated with urine or toilet water.
2.4.7.2 More than one (1) hour.

3. CONFIDENTIALITY OF RESULT
3.1 The laboratory staff is responsible for the maintenance and storage of its records.

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3.2 Records stored shall be filed, labeled and must be retain for period for at least two (2) years in
storage cabinet.
3.3 Records shall be placed in a folder of binder inside the designated storage cabinet to protect them.
3.4 The laboratory uses an electronic storage system that shall store and archive all records
electronically. This method will provide accurate representation of the original records.
3.5 The laboratory ensures the integrity of data electronically stored under its Information Technology
Facility.
3.6 The data stored electronically shall have a back-up copy
3.7 Vital and confidential test results will be released be the person responsible (medical technologist)

3.8 All test result will be released to the client/patient only or any authorized representative with date,
time and signature of the recipient.
3.9 All results whether received or released shall be signed by the person responsible indicating the
date and time.
3.10 This procedure is to ensure confidentiality of test results to protect disclosure to the public that
may adversely affect the interest of the client.
3.11 Relaying of results via phone is prohibited
3.12 Staffs are prohibited from talking about a patient’s results outside the laboratory or in the
presence of other people.
3.13 Only staffs of the company are allowed to access the patient’s records.
3.14 Disposal of copies of results are handled properly in such a way that the patient’s health status
is maintained confidential.

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 ADMINISTRATIVE AND TECHNICAL POLICIES AND PROCEDURES
1. LABORATORY TESTS AVAILABLE
1.1 CLINICAL MICROSCOPY
1.1.1 Routine Urinalysis
1.1.2 Routine Fecalysis
1.1.3 Pregnancy Test
1.2 CLINICAL HEMATOLGY
1.2.1 Complete Blood Count
1.2.2 Complete Blood Count with Platelet count
1.2.3 Platelet Count
1.2.4 Erythrocyte Sedimentation Rate
1.2.5 RBC Indices
1.2.6 Clotting and Bleeding time
1.2.7 Prothrombin time with INR
1.2.8 Activated Partial Thromboplastin Time
1.2.9 Blood typing – Forward typing
1.3 CLINICAL CHEMISTRY
1.3.1 Glucose
1.3.2 Total Cholesterol
1.3.3 Triglyceride
1.3.4 HDL/ LDL/ VLDL
1.3.5 Blood Uric Acid
1.3.6 Blood Urea Nitrogen
1.3.7 Creatinine
1.3.8 SGOT/AST
1.3.9 SGPT/ALT
1.3.10 OGTT (Oral Glucose Tolerance Test)
1.3.11 HBa1c
1.3.12 Alkaline Phosphatase
1.3.13 Albumin
1.3.14 Phosphorus
1.3.15 Sodium
1.3.16 Potassium
1.3.17 Ionized Calcium
1.3.18 Chloride
1.4 SEROLOGY
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 1.4.1 HbsAg Screening
1.4.2 VDRL
1.4.3 PSA
1.4.4 TSH
1.4.5 FT4
1.4.6 FT3
1.4.7 Troponin I

2. GENERAL FLOW CHART

START

PROCEED TO THIRD FLOOR

GET QEUE NUMBER FROM THE RECEPTION AREA

PHLEBOTOMIST WILL CALL OUT YOUR NUMBER

PROCEED TO THE LABORATORY FOR BLOOD EXTRACTION AND SUBMISSION OF URINE OR STOOL SPECIMENS

THE MEDICAL TECHNOLOGIST WILL RECEIVE THE SPECIMEN

PROPER IDENTIFICATION OF SPECIMEN AND REQUEST FORM

CHEMISTRY MICROSCOPY HEMATOLOGY SEROLOGY

CHEMISTRY ANALYZER MUST URINE: REPORT THE COLOR, ANALYZER MUST RUN CHECK FOR THE SPECIMEN
RUN QUALITY CONTROL TRANSPARENCY AND DIP THE QUALITY CONTROL REQUIREMENT OF THE TEST
EVERYDAY PRIOR TO URINE STICK EVERYDAY PRIOR TO REQUESTED
PROCESSING PATIENT’S STOOL: REPORT COLOR AND PROCESSING PATIENT’S
SPECIMEN CONSISTENCY. SPECIMEN
AFTER OBTAINING THE
DESIRED SPECIMEN, FOLLOW
ALLOW SPECIMEN TO CLOT URINE: CENTRIFUGE THE CHECK FOR CORRECT BLOOD THE MANUFACTURER’S
FOR 30 MINS, THEN URINE FOR 5 MINS TO ANTICOAGULANT RATIO, INSTRUCTION FOR THE KITS
CENTRIFUGED FOR 10 MINS STOOL: PREPARE SLIDE WITH AND FOR PRESENCE OF CLOT AND MACHINE.
NSS, STOOL AND COVER WITH
COVER SLIDE
TRANSFER SERUM INTO PROCESS IN THE ANALYZER
CUVETTE DECANT URINE IF CLOTTED REJECT SPECIMEN

RUN THE SPECIMEN IN THE PREPARE SLIDE FOR FOR VALUES OUTSIDE OF
ANALYZER
Page | 37
URINALYSIS NORMAL VALUE, DO THE
MANUAL METHOD FOR
RERUN RESULTS OUTSIDE OF MICROSCOPY OF URINE AND
NORMAL VALUE STOOL

ENCODING OF RESULTS, SIGNING, AND RELEASING.

3. GENERAL RULES AND REGULATION ON TECHNICAL PROCEDURES

3.1 REQUISITION/REQUEST FORM

Proper procedure assures adequate identification of the patient and the specimen and indicates the
examination desires and facilitates the reporting of report.
3.1.1 Identification of the patient
3.1.2 Age, gender
3.1.3 Requesting physician
3.1.4 Patient Diagnosis
3.1.5 In addition, the following information must be maintained by the laboratory
3.1.5.1 Condition of any unsatisfactory specimen
3.1.5.2 Type of test/procedure performed
3.1.5.3 Date and time requested and when specimen collected.
*The laboratory shall use its own official request form with all the required data
3.2 PATIENTS AND SPECIMEN IDENTIFICATION
3.2.1 Laboratory personnel must take utmost care with respect to the proper identification of
patient and specimen
3.2.2 The receiving personnel should ask the name of the patient
3.2.3 He/she shall positively identify the patient’s name and age, and check these against the
data written in the request form.
3.2.4 If the patient is incapable of stating his/her name, the laboratory personnel, must seek
proper identification by the other persons who know the patient such as relative or any
companion.

3.3 REPORTING
3.3.1 Hard copy Reports
3.3.1.1 A duly signed hard copy report by the medical technologist and pathologist.
3.3.1.2 All hard copy reports should bear the patient’s identification.
3.3.1.3 All hard copy reports are recorded in their respective logbooks for record keeping and
administrative purposes.
3.3.2 Verbal Reports
3.3.2.1 Verbal reports are prohibited. This is a major source of errors and mat result in
medical liability.
3.3.3 Cumulative Reports
3.3.3.1 When several analyses are performed from different section of the laboratory, the
results of the patients are presented as a table in a different paper depending on the
sections that provided the results.
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 3.3.3.2 The laboratory has to communicate abnormal results (critical) to ensure prompt and
reliable reporting. Appropriate record keeping and retrieval are also necessary.

3.4 EVALUATION OF TEST RESULT

3.4.1 In addition to adhering to given procedures, the laboratory staff has additional responsibility
to:
3.4.1.1 Evaluate test results with regards to their clinical relevance
3.4.1.2 Release results at releasing time, 2:30 PM- 3:30M, unless it is STAT.
3.4.1.3 Check the consistency of the results with regards to the patient’s conditions.

3.4.1.4 Screen critical values at the earliest opportunity to indicate a potentially dangerous
condition requiring immediate action/attention such as critical values.
3.4.1.5 STAT results are release after an hour of receiving the sample. STAT samples are
only applicable to Hematology and Clinical Microscopy.

3.5 PRE- ANALYTICAL VARIABLES

3.5.1 Test Utilization
3.5.1.1 The laboratory suggests and monitors the appropriateness of test requests.
3.5.1.2 It plays a role in identifying situation in which test utilization may be improved
3.5.2 Patient Identification
3.5.2.1 Correct identification of patient and specimen
3.5.3 Turn-Around-Time
3.5.3.1 All laboratory test results are scheduled to be released on the same day the specimen
is processed at 2:30PM – 3:30PM, unless otherwise state.
3.5.4 Patient Preparation
3.5.4.1 Laboratory results are affected by many factors as time of intake of food, alcohol,
drugs as well as smoking, exercise, stress, and sleep during specimen collection and
other variables
3.5.4.2 Proper preparation is essential
3.5.4.3 The laboratory has defined instructions and procedure for patient preparation both by
oral and written guide.
3.5.5 Specimen Collection
3.5.5.1 All laboratory staff are trained properly to collect specimen through venipuncture, and
finger-prick procedure.
3.5.6 Personnel
3.5.6.1 The competency of the people assigned responsibilities ids determined on the basis
of documented criteria in the applicable job description for appropriate education,
trainings, skills and experience for each required competency or work assignment.
3.5.6.2 The personnel shall be evaluated yearly.
3.5.6.3 And they shall be allowed to attend quality management programs, seminars or other
seminars/trainings related to their job description.
3.6 ANALYTICAL VARIABLES
3.6.1 Instrument Based. Analytical analyzers before processing of patient’s samples should be
in perfect condition and quality controls and calibrators are run first.
3.6.2 Temperature. Records are kept and maintained.
3.6.3 Individual Based. This variable relates directly to one’s skills, regarding specimen
preparation, knowledge of instruments and manual methods.

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 3.6.4 Standard and Calibration. Highest quality method or the definitive methods are used to
validate reference methods.
3.6.5 Control Materials. Specimens or solutions analyzed solely for quality control purposes and
not for calibration. Must be stable, available in aliquots or vials, which can be analyzed
periodically over a long time.
3.6.6 Work Environment. The work environment must be safe for the employees. It should also
allow an efficient way of working.
3.6.7 Equipment/Supplies/Reagents. The Chief Medical Technologist ensures the suitability and
availability of equipment’s and supplies used for the performance of the service offered.

3.6.8 Documentation and Recording. All analytical procedures shall be documented and
recorded in corresponding logbooks for future reference. A laboratory file hard copy is kept
for a period of three (3) years.
3.6.9 Releasing. All laboratory reports shall bear the name and signature of the medical
technologist who performed the test and of the pathologist. The receiving person/ patient
shall affix his/her signature in the releasing logbook once the result is released.

4. SPECIMEN COLLECTION AND PATIENT PREPARATION

4.1 GENERAL RULES ON SPECIMEN COLLECTION

4.1.1 Universal precaution should be followed at all times, Blood and other body fluids are
considered infective.
4.1.2 All persons collecting and processing blood and body fluids specimens should wear gloves,
mask and protective laboratory gown. Gloves should be changed and hands are washed
after completion of specimen processing
4.1.3 All laboratory staff must take precautions to prevent injuries caused by needles, scalpels
and other sharp instruments.
4.1.4 Staff with exudative lesions or weeping dermatitis should refrain from all direct patient care
until the conditions is resolve.

4.2 BLOOD SPECIMEN

4.2.1 VENIPUNCTURE
4.2.1.1 Greet the patient. Establish a good rapport with the patient.
4.2.1.2 Upon receiving the request form, check for the patient’s information and verify the
patient identification by asking for a valid identification card, name, age, contact no.
and any other identification written in the request form. If the patient has no ID, the
patient must dictate his/her name.
4.2.1.3 If fasting or any patient preparation is required for the test requested the following
must be follow and instructed to the patient:
4.2.1.3.1 Exercise or muscular activity: either excessive or no causes transient
biochemical constituent in the plasma.
4.2.1.3.2 The following requires a minimum of six (6) hours and a maximum of eight (8)
hours fasting:
4.2.1.3.2.1 Fasting Blood Sugar (FBS)
4.2.1.3.2.2 Oral Glucose Tolerance Test (OGTT)
4.2.1.3.3 The following requires a minimum of ten (10) hours fasting and a maximum of
twelve (12) hours fasting:

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 4.2.1.3.3.1 Total Cholesterol
4.2.1.3.3.2 High- density lipoprotein (HDLL
4.2.1.3.3.3 Low-density Lipoprotein (LDL)
4.2.1.3.3.4 Very low-density lipoprotein (VLDL)
4.2.1.3.4 The following requires a minimum of twelve (12) hours and a maximum of
fourteen (14) hours fasting:
4.2.1.3.4.1 Triglycerides

4.2.1.3.5 The following requires a fasting of ten (10) hours:

4.2.1.3.5.1 FBS with Lipid Profile (Total Cholesterol, Triglycerides, HDL, LDL and VLDL)
4.2.1.4 Assemble the supplies needed for venipuncture.
4.2.1.5 Position the patient properly for easy and comfortable access to the antecubital fossa.
4.2.1.6 Apply tourniquet three (3) to four (4) inches above the puncture site. Never leave the
tourniquet in place linger than one (1) minute.
4.2.1.7 Select the suitable vein for puncture. Veins for antecubital fossa, in particular, the
medial cubital, and the cephalic veins are preferred.
4.2.1.8 In case of difficulty accessing a venous line, the phlebotomist or medical technologist
staff shall must ask the assistance of a chief medical technologist or doctors on duty
for venipuncture procedure.
4.2.1.9 Arterial procedure is prohibited.
4.2.1.10 The phlebotomist or medical technologist shall inform the patient of the
procedure.
4.2.1.11 Anchor the vein firmly, both above and below the puncture site.
4.2.1.12 Apply the proper aseptic technique using 70% isopropanol solution. Allow the
area to dry. Do not touch the swabbed are with any unsterile object.
4.2.1.13 Perform the venipuncture: enter the skin with the needle approximately 15 to 30
degrees angle to the am, bevel up, when the back flow of the blood is seen pull the
plunger smoothly to avoid hemolysis and collect the exact amount of blood needed in
the barrel.
4.2.1.14 If several tests are requested you can use the venipuncture using vacutainer
tube. Please follow the order of draw of tube:
4.2.1.14.1 Blood Culture – Yellow Top
4.2.1.14.2 Citrated tube/ Blue top
4.2.1.14.3 Plain tube - Red top
4.2.1.14.4 Heparinized tube – Green Top
4.2.1.14.5 EDTA Tube – Violet/Purple Top
4.2.1.14.6 Fluoride Tube – Gray Top
4.2.1.15 Release the tourniquet when blood begins to flow, never withdraw the needle
with the tourniquet still attached.
4.2.1.16 Place a clean sterile cotton ball or gauze lightly over the site. Withdraw the
needle, then apply pressure to the site.
4.2.1.17 Apply an adhesive bandage strip over the cotton ball or gauze to adequately stop
bleeding and avoid hematoma.
4.2.1.18 All specimen must be properly and legibly labeled. Labeling shall be performed
immediately after venipuncture.

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 4.2.1.19 Mix and inverts the tubes with anticoagulant, do not shake the tubes.
4.2.1.20 Dispose of the contaminated materials such as needles, syringes, and cotton in a
designated container.

4.2.2 SKIN PUNCTURE

4.2.2.1 Select an appropriate puncture site. For infants, usually it is the lateral or medial
plantar heel surface. In older infants, the palmar surface of the last digit of the second,
third or fourth fingers may be used. Other sites for skin puncture are the plantar
surface of the big toe, the lateral side of a finger adjacent to the nail, and the earlobe.
The site or puncture must not be edematous or a previous puncture site.

4.2.2.2 Warm the puncture site with a warm, moist towel no hotter than 42°C, this increases
the flow of blood.
4.2.2.3 Apply the proper aseptic technique using 70% isopropanol solution. Allow the area to
dry. D not touch the swabbed area with any unsterile object.
4.2.2.4 Make the puncture with a sterile lancet. Use a lancet with a blade no longer than 2.4
mm to avoid injury to the calcaneus (heel bone).
4.2.2.5 Discard the first drop of blood by wiping it away with a sterile pad. Regulate further
blood flow by gentle thumb pressure. Do not milk the site because this may hemolyze
the specimen and introduce excess tissue fluid.
4.2.2.6 Collect the specimen in a suitable container by capillary action.
4.2.2.7 Seal the specimen container using clay at the each of the capillary tubes.
4.2.2.8 Mix the sample if it is collected in a microtainer with anticoagulant.
4.2.2.9 Label the specimen container. Labeling shall be performed immediately after
venipuncture.

4.2.3 URINE SPECIMEN

4.2.3.1 Greet the patient. Receive the request form for urinalysis.
4.2.3.2 Upon receiving the request form, check for the patient’s information and verify the
patient identification by asking for a valid identification card, name, age, contact no.
and any other identification written in the request form. If the patient has no ID, the
patient must dictate his/her name.
4.2.3.3 Instruct the patient to catch the clean midstream portion of the urine.
4.2.3.4 For female patient, urinalysis is done after 7 days of the last day of menstruation
otherwise advised/requested by her attending physician.
4.2.3.5 A urine specimen must be submitted in the laboratory in a sealed vessel, labeled
properly.
4.2.3.6 Check the validity of the specimen by examining the physical appearance and
volume.
4.2.3.7 “QNS” and contaminated specimen must be rejected and instruct the patient to repeat
collection.
4.2.3.8 STAT urinalysis must be given priority and result must be release one (1) hour after
submission of specimen.

4.2.4 SAMPLE FOR CULTURE AND SENSITIVITY

4.2.4.1 Specimens for culture and sensitivity testing shall be collected in a sterile container.
Early morning specimen is recommended for sputum and urine culture, or as directed
by the clinician.

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5. STANDARD OPERATING PROCEDURE IN CLINICAL CHEMISTRY
5.1 CHEMISTRY PROCEDURE
5.1.1 Upon receipt of blood samples and request form in the chemistry section, the medical
technologist shall check the tube labels against the name in the request.
5.1.2 Centrifuge the clotted blood sample (about 15-30 mins after collection) for 10 minutes at a
relative RPM of 850 to 1000x gravity. After centrifugation, check for any evidence of
hemolysis, lipemia, icterus, and chyle.
5.1.3 Blood chemistry shall be processed using automated analyzer, AMS Liasys. Refer to user
manuals fir detailed technical procedures of the analyzer.

5.1.4 The following are the principles used by each test:

5.1.4.1 Glucose – Oxidase-peroxidase Method
5.1.4.2 Blood Urea Nitrogen – Urease Method
5.1.4.3 Creatinine – Jaffe Method
5.1.4.4 Blood Uric Acid – Urate Oxidase
5.1.4.5 Cholesterol – Oxidase
5.1.4.6 Triglyceride – Oxidase
5.1.4.7 AST/SGOT – IFCC
5.1.4.8 ALT/ SGPT – IFCC
5.1.4.9 HDL – Direct Method
5.2 CRITICAL VALUES FOR CLINICAL CHEMISTRY
5.2.1 AST/SGOT: > 100mg/dL
5.2.2 ALT/SGPT: > 100mg/dL
5.2.3 BUN: >30 mg/dL (no history of renal disease); >100 mg/dL (patient with history of renal
disease)
5.2.4 FBS: <50 or >300 mg/dL
5.2.5 BUA: >12 mg/dL
5.2.6 Creatinine: >7.0 mg/dL
5.2.7 Triglyceride: >700 mg/dL
5.2.8 Sodium: <100 or >160 mmol/L
5.2.9 Potassium: <2.0 or >6.0 mmol/L
5.3 FLOWCHART IN CLINICAL CHEMISTRY
Test Request Received

Collection of Specimen (Blood Extraction)

Submit Sample to the Laboratory

Sample Analysis:
Adequate volume and correct specimen

NO YES

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REJECT SPECIMEN, ADVICE FOR RECOLLECTION START PROCESSING

ENCODING, SIGNING OF RESULT

RELEASING OF RESULT

6. STANDARD OPERATING PROCEDURE IN CLINICAL HEMATOLOGY

6.1 HEMATOLOGY PROCEDURE AUTOMATED
6.1.1 Upon receiving the request, the medical technologist or phlebotomist will check for the test
requested, and prepare the materials needed for venipuncture or finger –prick method. Use
an EDTA tube/violet top tube for tests like, CBC, PC, ESR, differential count and blood
typing. Use the citrated tube/ blue top for coagulation studies like prothrombin time and
partial thromboplastin time.
6.1.2 Dymind DF50 hematology analyzer is the machine used for automated blood count
procedures.
6.1.2.1 The controls must be run first before the patient’s samples. Make sure that the
controls are in room temperature before running.
6.1.2.2 Disinfect the hematology section including the analyzer and working table.
6.1.2.3 Specimens received in the hematology section shall be checked by the medical
technologist, the label on the tube and the information on the request form. Check for
any clot, and mix the EDTA tube for 8 times. If there are any clot present, reject the
specimen, and call for recollection.
6.1.2.4 Feed the specimen to the hematology analyzer, by direct contact of the probe and the
whole blood inside the tube. The probe does not puncture through the tube, the top
must be removed manually before inserting the probe inside the tube.
6.1.2.5 After the machine has finished feeding the specimen, the probe will retract inside the
machine and start processing.
6.1.2.6 After processing the results are reflected in the monitor. The medical technologist
must input the details of the patients corresponding to its result.
6.1.2.7 STAT hematology result shall be released one (1) hour after specimen collection.
6.1.3 Wondfo Coagulation machine is the machine used for coagulation studies.
6.1.3.1 Make sure that the machine is calibrated.
6.1.3.2 Specimens received in the hematology section shall be checked by the medical
technologist, the label on the tube and the information on the request form. Check for
any clot, and mix the citrated tube for 4 times. If there are any clot present, reject the
specimen, and call for recollection.
6.1.3.3 Take out the kit with the needed test from the request form. Insert the kit in the
machine, and the machine will automatically detect the test due to the barcode
attached to the kits. Input the name of the patient. Incubation period will start, and
once the ‘input sample’ appears, pipette 20uL of whole citrated blood and dispense it
in the specimen well.
6.1.3.4 The machine will start processing. After processing it will print out the result.

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 6.1.3.5 STAT hematology result shall be released one (1) hour after specimen collection.

6.2 MANUAL HEMATOLOGY PROCEDURE

6.2.1 Materials:
6.2.1.1 Counting chamber and thoma pipettes.
6.2.1.2 Drabskin’s solution for hemoglobin using Sahli pipette, WBC and RBC diluting fluid.
6.2.1.3 Wright stain
6.2.1.4 Capillary tube
6.2.1.5 Sealer/clay
6.2.1.6 Micro hematocrit reader
6.2.1.7 Differential Counter

6.2.2 HEMATOCRIT DETERMINATION PROCEDURE:

6.2.2.1 Fill at least two (2) capillary tubes approximately 2/3 full. If using tubes with a colored
ring at one end, fill from opposite end.
6.2.2.2 Seal unfilled end with non-absorbent sealing material.
6.2.2.3 Place capillary tubes in opposite slots of micro-hematocrit centrifuge with the clay-
filled end against the gasket. Be sure to note position number if spinning specimens
from more than one (1) patient.
6.2.2.4 Place the head cover of the centrifuge and spin for five (5) minutes or the minimum
time determined for maximum call packing of the centrifuge. Open the lid and remove
the tubes one at a time reading.
6.2.2.5 Determine the hematocrit by using the hematocrit reading device.
6.2.3 HEMOGLOBIN DETERMINATION PROCEDURE
6.2.3.1 Suck blood up to 20 marks on the Sahli pipette.
6.2.3.2 Draw blood to 5mL of Drabkin’s solution and let stand for ten (10) minutes.
6.2.3.3 Use water blank
6.2.3.4 Read at 540 nm

6.2.4 WHITE BLOOD CELL COUNT PROCEDURE

6.2.4.1 Draw blood up to 0.5 mark of the WBC pipette and the diluting fluid up to mark 11.
Wipe of excess blood outside the pipette before immersing it in the diluting fluid.
6.2.4.2 Shake using the mechanical pipette shaker or manually
6.2.4.3 Discard the first four drops and immediately fill both sides of the counting chamber
making sure not to over fill the chamber.
6.2.4.4 Focus under low power field. Adjust the light so that the leukocytes appear slightly
iridescent round bodies with definite outline.
6.2.4.5 Counting the cells in the four corners (WBC square) of the counting chamber. Include
in the count those cells that lay half in and half out of the upper and left-hand lines.
6.2.4.6 Count both sides of the counting chamber
6.2.4.7 Calculation: No. of cells counted x 50 = WBC count
6.2.4.8 Normal Value: 4.5 to 11.0 x 109/L

6.2.5 PLATELET COUNT (REESE AND ECKER METHOD) PROCEDURE

6.2.5.1 Draw blood up to 0.5 mark of the red cell pipette.
6.2.5.2 Draw platelet diluting fluid (Reese and Ecker) up to mark 101, wipe off the excess
blood outside the red cell pipette.
6.2.5.3 Shake the pipette using the pipette shaker machine or manually.

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 6.2.5.4 Discard the first four drops and immediately fill both sides of the counting chamber
making sure that the chamber is not over charged.
6.2.5.5 Allow to stand for 15 mins. In a closed petri dish kept moist with wet filet paper.
6.2.5.6 Count the platelets in the finely lines of the chamber
6.2.5.7 Note: the platelets are bluish and must be distinguished from debris. They are oval,
round or comma shape and vary in size from 1-5 micra.
6.2.5.8 Formula: Plt x 20 x 1/0.2 = plts/uL
6.2.5.9 Normal Value: 150,000- 450,000/ cu mm

6.2.6 DIFFERENTIAL COUNTING

6.2.6.1 Blood smear preparation
6.2.6.1.1 Place a drop of blood at 0.05 inch from the edge of the slide
6.2.6.1.2 With the help of a spreader slide, position the spreader at 45-degree angle and
spread the blood making a thick and thin characteristic of a blood smear.
6.2.6.1.3 Air Dry
6.2.6.1.4 Label with patient’s name
6.2.6.2 Staining (Wright Stain)
6.2.6.2.1 Filter the stain daily. Make sure smears are thoroughly dried before staining.
6.2.6.2.2 Follow the manual instructions of the stain set, if applicable.
6.2.6.2.3 Dip the slide in solution one (1)/Fixative/methanol, six (6) times
6.2.6.2.4 Dip the slide in the solution two (2)/orange eosinophilic solution six (6) times
6.2.6.2.5 Dip the slide in solution three (3)/Blue basophilic solution six (6) times.
6.2.6.2.6 Air dry the slide; the slide should be pinkish violet.
6.2.6.3 Reading
6.2.6.3.1 Read 100 WBC cells in oil immersion objective start from the feathery edge of
the smear using the differential counter.

6.2.7 RED BLOOD CELL PROCEDURE

6.2.7.1 Draw blood up to 0.5 mark of the RBC pipette and the diluting fluid up to mark 10.
Wipe of excess blood outside the pipette before immersing it in the diluting fluid.
6.2.7.2 Shake using the mechanical pipette shaker or manually.
6.2.7.3 Discard the first four drops and immediately fill both sides of the counting chamber
making sure not to over fill the chamber.
6.2.7.4 Wait for t3 to 5 minutes so that the cells settle down.
6.2.7.5 Focus under high power field. Count the four corner squares and one central square.
Only count the RBCs that touch the top and left borders of the squares.
6.2.7.6 Formula: total number of RBC x 10,000
6.2.7.7 Normal Value: Men = 4.3-5.9 m/mm3; Women = 3.5-5.5 m/mm3

6.2.8 ERYTHROCYTE SEDIMENTATION RATE

6.2.8.1 PROCEDURE;
6.2.8.1.1 Fill the wintrobe tube up to the zero line
6.2.8.1.2 Place the wintrobe tube in tan exactly vertical position at room temperature and
observe the point on the mm scale which the corpuscles fall at exactly 1 hour.
6.2.8.2 Normal value: 0-20 mm/hr.

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 6.3 FLOWCHART IN CLINICAL HEMATOLOGY

Test Request Received

Collection of Specimen (Blood Extraction)

Submit Sample to the Laboratory

Sample Analysis:
Adequate volume and correct specimen

NO YES

REJECT SPECIMEN, ADVICE FOR RECOLLECTION START

PROCESSING

CHECK FOR MANUAL CHECKING OF RESUTLS

ENCODING, SIGNING OF RESULT

Page | 47
 RELEASING OF RESULT

7. STANDARD OPERATING PROCEDURE IN CLINICAL MICROSCOPY

7.1 Routine Urinalysis
7.1.1 Principle. The Microscopic examination is a vital part of the routine urinalysis. It is a valuable
diagnostic tool for the detection and evaluation of renal and urinary tract disorders as well as
other systemic disease.
7.1.2 Materials required:
7.1.2.1 Conical centrifuge tube
7.1.2.2 Microscope slides
7.1.2.3 Cover slips
7.1.2.4 Urine reagent strip
7.1.3 Equipment:
7.1.3.1 Microscope
7.1.3.2 Centrifuge 2000 RPM
7.1.4 Procedure
7.1.4.1 Note the color, clarity and volume of urine and record on the request form or on the
urinalysis worksheet.
7.1.4.2 Using the urine dipstick, immerse it into the urine and compare with the chart given by
the manufacturer. Note the reading and record on the request or urinalysis worksheet.
7.1.4.3 The urine must be 10-15mL to be acceptable. Mix the sample well and pour 4-5mL
into a clean test tube.
7.1.4.4 Centrifuge at 10000 RPM for 5 minutes.
7.1.4.5 Decant, mix and place a drop of the sediment on a clean slide and cover with a cover
slip.
7.1.4.6 Examine under low-power objective to locate cast and elements that are present in
only a few fields.
7.1.4.7 Note the presence and type of crystals and cast and report them depending on their
presence:
7.1.4.8 View the sediment in the high-power objective.
7.1.4.9 Count the number of WBC and RBC in 10 fields, rate the number of cells as per field
start from the lowest to the highest number counted field. Note and record.
7.1.4.10 Estimate the number of epithelial cells, mucous threads, and bacteria per high-
power field in observing 10 fields.

7.2 Exton’s Test (Sulfo-Salicylic Acid/ Precipitation Test)

7.2.1 Acid will precipitate protein out of causing the solution to become cloudy. Amount of
cloudiness is related to the amount of protein present, Protein: SSA (Exton’s Test). Amount
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 of cloudiness is evaluated thus must use centrifuge urine. Sensitivity 5-10 md/dL. Specificity:
detects all protein.
7.2.2 False positive result: radiographic dye; uncentrifuged urine. False negative results: High
alkaline urine
7.2.3 Procedure: Mix together 3mL or centrifuged urine and 3mL of Exton’s reagent. Warm the
solution until cloudiness is formed. A positive control must be done together with the
sample.

7.2.3.1 Manner of reporting:

PHYSICAL EXAMINATION
Colorless, Light yellow, Yellow, Dark
COLOR: yellow, Amber, etc.

TRANSPARENC
Y DESCRIPTION
Clear No visible particulates
Hazy Few particulates, print easily through urine
Cloudy Many particulates, print blurred through urine
Turbid Print cannot be seen through the urine
Milky May precipitate or be clotted

CHEMICAL EXAMINATION: 1+, 2+, 3+, 4+

MICROSCOPIC EXAMINATION:
SEDIMENT O.L GRADING REMARKS
None: 0 Intact
Range: 0-2, 2-5, 5-
RED BLOOD CELLS HP
10, 10-25, Crenated
(RBCs) F
25-50, 50-100,
>100 Dysmorphic
None: 0 WBC in clumps
Range: 0-2, 2-5, 5-
WHITE BLOOD CELLS HP
10, 10-25,
(WBCs) F Glitter cells
25-50, 50-100,
>100
None: 0
Range: 0-2, 2-5, 5- Note cast type
CASTS LPF
10, >10

Renal Tubular Epithelial

Cells (RTE) HP None: 0
F Range: 0-2, 2-5, 5-
and Oval Fat Bodies
10, >10
Squamous Epithelial Cells LPF None: 0, Rare: 0-5,
Few 5-20

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 Moderate: 20-100,
Many: >100
None: 0, Rare: 0-2,
HP Few 2-5
Transitional Epithelial Cells
F Moderate: 5-20,
Many: >20
None: 0, Rare: 0-1,
Few 1-3
Mucous Thread LPF
Moderate: 3-10,
Many: >10
None: 0, Rare: 0- Noteworthy
HP 10, Few 10-50 in fresh
Bacteria
F Moderate: 50-200,
specimen
Many: >200
None: 0, Rare: 0-2,
HP Few 2-5
Normal Crystals
F Moderate: 5-20,
Many: >20
None: 0
Abnormal Crystals LPF Range: 0-2, 2-5, 5-
10, >10
None: 0
HP
Trichomonas vaginalis Range: 0-2, 2-5, 5-
F
10, >10
Indicate if
HP Note presence budding
Yeast
F or with mycelia
forms
HP Note presence
Sperm cells
F

7.2.3.2 Note any Trichomonas vaginalis seen and estimate the number per field (0-1, 0-3,
etc.)
7.2.3.3 Note the presence of any yeast cell and indicate if it is budding or hyphae.
7.2.3.4 Note any other organisms seen, and if glitter cell or clue cell is seen.
7.2.3.5 Record the results obtained on the urinalysis worksheet.

7.3 ROUTINE FECALYSIS

7.3.1 COLLECTION AND HANDLING OF STOOL SPECIMENS
7.3.1.1 Collect directly into a clean, dry container and bring entire specimen to the laboratory.
7.3.1.2 Patient should be well instructed on specimen collection, and the time interval for the
specimen to be processed after collection.
7.3.1.3 Stools should be processed within one hour. If the stool will be examined more than
an hour after its collection, it must be refrigerated. Trophozoites from refrigerated
specimens can regain motility in warm saline or warm slide.
7.3.1.4 Thirty-seven degrees Celsius can destroy amoebas.

7.3.2 DIRECT EXAMINATION – WET MOUNT/ SALINE PREPARATION

7.3.2.1 After receiving the specimen, note the color and consistency
7.3.2.2 Prepare a slide, add a drop of NSS, and scoop a small amount of specimen and mix
well.
7.3.2.3 Cover with a cover slip.
7.3.2.4 Using the microscope, at low-power objective, scan the slide systematically.

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 7.3.2.5 Check for any parasite, and its motility, if there is one.

7.3.3 DIRECT EXAMINATION – IODINE-STAINES PREPARATION

7.3.3.1 After receiving the specimen, note the color and consistency
7.3.3.2 Prepare a slide, add a drop of NSS and Lugol’s iodine, and scoop a small amount of
specimen and mix well.
7.3.3.3 Trophozoites can no longer be seen since they are destroyed by iodine.
7.3.3.4 Cytoplasm of protozoan cysts stains yellow-brown.
7.3.3.5 Nuclear chromatin can easily be seen and number if nuclei counted.
7.3.3.6 Chromatid bodies do not stai

7.3.4 MANNER OF REPORTING

PHYSICAL EXAMINATION

* COLOR
* CONSISTENCY
SEDIMENTS OBJECTIV GRADING
E

PUS CELLS HPF No reporting of pus cells

(WHITE BLOOD CELLS) unless present.
WBCS

RED BLOOD CELLS HPF No reporting of RBC unless

present.

HPF No reporting of yeast cells unless

YEAST CELLS present.

FAT GLOBULES HPF No reporting of fat globules

unless present.

BACTERIA HPF NO REPORTING OF

BACTERIA.

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 PARASITE HPF Qualitative reporting only
(Example: POSITIVE for
Entamoeba species)

7.4 FLOWCHART IN CLINICAL MICROSCOPY

Test Request Received

Collection of Specimen

Submit Sample to the Laboratory

Sample Analysis:
Adequate volume and correct specimen

NO YES

REJECT SPECIMEN, ADVICE FOR RECOLLECTION START PROCESSING - MICROSCOPY

ENCODING, SIGNING OF RESULT

RELEASING OF RESULT

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 COMMUNICATION AND RECORDS
1. GENERAL RULES AND REGULATIONS
1.1 The proper laboratory request form must be completely filled up with the following information:
1.1.1 Name of the patient
1.1.2 Age
1.1.3 Gender
1.1.4 Date
1.1.5 Name of the attending physician
1.1.6 Diagnosis of the patient
1.1.7 Contact no. of the patient
1.1.8 Fasting hours – for laboratory tests that requires fasting
1.1.9 Laboratory test request(s)
1.2 The receptionist will give the laboratory number to each patient for an efficient flow of people inside the
extraction area and receiving area.
1.3 Indicate in the request form if it is STAT, otherwise it will be release on the afternoon at 2:30PM- 3:30PM.
1.4 Identify the desired examination and check if it is available in the laboratory.
1.5 Once the test has been performed, there will be no more cancellation of the request.
1.6 All data in the request forms and receipt shall be recorded properly and completely in their designated
laboratory logbook.

2. PROTOCOL ON ROUTINE AND STAT SPECIMENS

2.1 ROUTINE SPECIMENS
2.1.1 Receipt
2.1.1.1 The staff should check for the completeness of patient’s data:
2.1.1.1.1 Name of the patient
2.1.1.1.2 Age/Gender
2.1.1.1.3 Date
2.1.1.1.4 Name of the attending physician
2.1.1.1.5 Diagnosis
2.1.1.1.6 Contact No.
2.1.1.1.7 Laboratory test request
2.1.2 Check for the acceptability of specimen, proper anticoagulant to blood ration, and life
span of the specimen.

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 2.1.3 For test(s) that needs fasting the phlebotomist or medical technologist should ask the
patient if they observed proper fasting hours.
2.1.4 Specimens received are performed immediately.
2.1.5 Reporting of results:
2.1.5.1 Results should be signed by the medical technologist who performed the test
2.1.5.2 Releasing of results are in the afternoon at 2:30PM – 3:30PM, unless stated
otherwise
2.1.5.3 Patient must bring the receipt or health card, whichever is applicable, with their
valid ID for claiming of results.
2.1.5.4 The patient must sign in the releasing logbook after receiving the result
2.1.5.5 For patients who wants another copy of their result, a payment of PHP 10.00 per
page is charge to the patient.

2.2 STAT REQUEST

2.2.1 STAT request is only available for hematology and microscopy section not including
the ESR test.
2.2.2 The test is performed immediately, and must be finished within an hour after
receiving the specimen.
2.2.3 STAT request has addition charge of PHP 50.00 per test.

3. REPORTING AND VALIDATION OF RESULT

3.1 ROUTINE RESULT
3.1.1 The laboratory must report accurate and precise result.
3.1.2 Blood chemistry results should be released at 2:30PM, except for those blood
procedures for send-out, culture and with schedule running.
3.1.3 Routine hematology results are released at 2:30PM, except for procedures for send
out.
3.1.4 Routine hematology results are released at 2:30PM, except for procedures for send
out.
3.1.5 All send-out procedures will be released the following day after collection except for
culture and sensitivity, and peripheral blood smear which are released once the
results are available.
3.1.6 All laboratory results are computer printer, verified, reviewed and passed the quality
control prior to release. All result released must acknowledge by signing in the
releasing logbook.
3.1.7 Patient must bring the receipt or health card, whichever is applicable, with their valid
ID for claiming of results
3.1.8 Never relay or interpret results to the patient, patient’s relative and other
unauthorized persons. When a representative is sent to pick-up the result, always
ask for filled up authorization letter duly signed by the patient, with the patient’s ID
and representative.
3.1.9 For patients who wants another copy of their result, a payment of PHP 10.00 per
page is charge to the patient
3.1.10 Strictly no results can be relayed through phone or text message
3.1.11 For patients requesting for results through email, the result will bear no signature of
the medical technologist and of the pathologist.

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3.2 STAT Result
3.2.1 ‘STAT’ stands for short-turn-around-time
3.2.2 STAT specimen must be released after an hour.
3.2.3 Results shall be logged accordingly.
3.2.4 Patient must bring the receipt or health card, whichever is applicable, with their valid
ID for claiming of results
3.2.5 Patient must bring the receipt or health card, whichever is applicable, with their valid
ID for claiming of results
3.2.6 Strictly no results can be relayed through phone or text message
3.2.7 For patients requesting for results through email, the result will bear no signature of
the medical technologist and of the pathologist.

3.3 VALIDATION OF RESULT

3.3.1 All official results must be signed by the Medical Technologist assigned in the
section, and a validator, who is a Medical Technologist (validator) who is assigned in
different section, or the assigned validator of result, will validate and double check
the result.
3.3.2 The validator can ask tor re-run specific test(s), if she/he is doubtful of the final result.
3.3.3 In summary, the official result should have 3 signatures in total. The first one is the
Medical Technologist who run the required test(s). Second, is a Medical Technologist
who validated the results. And lastly, is the signature of the pathologist.
3.3.4 All persons that signs shall include their PRC license and position.
3.3.5 This will help prevent and minimize typographical errors in results.
3.3.6 Criteria for Validation:
3.3.6.1 The official result must be signed by the medical technologist who run the test(s),
before giving it to the validator for validation.
3.3.6.2 The official result must match the information on the final output decided by the
medical technologist who run the test.
3.3.6.3 If all results meets the criteria and checklist of WHO, the validator can sign the
result, and prepare for releasing.
3.3.7 WHO Checklist for Validation of Test Results
3.3.7.1 Patient ID
3.3.7.2 Pre-analytical phase
3.3.7.2.1 Patient was correctly identified
3.3.7.2.2 Patient was properly prepared for sample collection
3.3.7.2.3 The person collecting the samples was correctly identified
3.3.7.2.4 Sample was labeled correctly and clear
3.3.7.2.5 The request form matches the specimen
3.3.7.2.6 The request form contains correct and clear contact details of the
requester
3.3.7.2.7 The date and time of collection is indicated on the request form
3.3.7.2.8 The specimen was transported appropriately to the laboratory
3.3.7.2.9 The specimen was received in acceptable condition
3.3.7.2.10 The log book entry matches the specimen label
3.3.7.3 Analytical

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 3.3.7.3.1 Reagents and test kits used were within expiry date
3.3.7.3.2 Quality controls associated with the result were acceptable
3.3.7.3.3 There were no flags on the analyzer’s results that need investigation
3.3.7.3.4 If diluted, the final results were calculated correctly with the correct
dilution factor
3.3.7.3.5 Results are within the biological reference intervals
3.3.7.3.6 Panic (critical) values are confirmed
3.3.7.3.7 The results make clinical sense
3.3.7.3.8 Confirmatory testing or established testing algorithms were completed
3.3.7.3.9 If applicable: previous patient results are available to assist with
interpretation of current sample’s result
3.3.7.4 Post Analytical
3.3.7.4.1 The report shows an appropriate result including test and result match for
each test requested
3.3.7.4.2 Proper concentration units for results are used

3.3.7.4.3 The decimal place is correct (if results have decimals)

3.3.7.4.4 The persons performing the tests are identified
3.3.7.4.5 All results and documentation are legible
3.3.7.4.6 In case of results within critical intervals the need for immediate
notification is indicated on the report and an immediate notification form is
used to verify correct reception of the result report by the requester
3.3.7.4.7 If applicable, the report contains interpretative information to assists the
clinician
3.3.7.4.8 The release of the results is dated and timed

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 PROCEDURE FOR REPORTING WORKLOD, QUALITY CONTROL AND INVENTORY
1. PROCEDURE FOR REPORTING OF WORKLOAD
1.1 Staff workloads in each laboratory section shall be recorded on a daily basis. This can be measured
with the following formula:
Number of workload = Number of Actual Test + Number of test repeated + (number or QC
run x Number of Lab Test) + Number of QC repeat Test
1.2 The running of QC materials, which comprise 2 levels for clinical chemistry and 3 levels for
hematology, shall be done and recorded daily and shall do the Levey-Jennings chart monthly.
1.3 If the workload has exceeded the capacity of a single medical technologist on duty, she/he shall
request for additional manpower.
1.4 The head of the laboratory shall make recommendations to the director.
1.5 Running of QC material for more than once for each level in hematology should be counted in the
control inventory, for proper monitoring of the control inventory, thus aiding in timely procurement.
1.6 Stock card are available in every section. Consumption of control material shall be strictly
monitored.
1.7 Laboratory work load (Census) must be documented monthly. This includes the test(s) and number
of requisition for each laboratory procedure(s). Both soft and hard copy of the document must be
secured and reported to the laboratory head every meeting.

2. PROCEDURE FOR REPORTING OF INVENTORY CONTROL

2.1 Inventory is detailed, itemized, especially a periodic survey of all reagents and supplies stock
2.2 Inventory Procedure
2.2.1 Observe the physical inventory count.
2.2.2 Cut off analysis for the requisition of supplies and reagents
2.2.3 First in first out policy
2.2.4 Inventory allowances. There should be a buffer for every reagent and supplies especially for
fast moving.
2.2.5 Log/record in the inventory every items received including the following data: data delivered;
date consumed; date of expiry
2.2.6 Monitor and log every item used
2.2.7 Update monthly inventory sheet and send to purchasing department.
2.3 It is the responsibility of the medical technologist who opened a new batch or reagents/kits to make
the accurate documentation in the inventory stock, affix his/her signature.

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 2.4 To maintain an adequate supply of reagents, the chief medical technologist shall determine the
average monthly consumption of each and maintain an inventory stock for 2 months.
2.5 The chief medical technologist shall centralize and collate all documents pertaining to stock
inventory,

3. PROCEDURE FOR REPORTING OF QUALITY CONTROL

3.1 The medical technologist will log in the quality control result daily in their designated logbook.
3.2 A chart of levey-jenning is done monthly and is composed of the result of the quality control
3.3 To assure the quality of the result the following are done on a regular basis.
3.3.1 Make sure all the machines/instruments/equipment are free of contamination
3.3.2 Checking of expiration dates of reagents and test kits
3.3.3 Daily running of QC
3.3.4 Pipettes must be calibrated
3.3.5 Reagents for staining is changed regularly
3.3.6 Centrifuge must be calibrated.
3.3.7 Refrigerator must be working efficiently and achieve the desired temperature for storage.

PROCEDURE FOR REPORTING AND ANALYSIS OF INCIDENTS, AND ADVERSE EVENTS

1. Adverse incidents shall be dealt with utmost care, logic and professionalism, the persons involve shall
submit an incident report (IR) to the administrative office, and HRD.
2. The administrator shall investigate and analyze the situation. Once the investigation and analysis is
done, the administrator shall make a recommendation report.
3. CORRECTIVE ACTION
3.1 Evidence of non-conforming service, customer dissatisfaction or ineffective processes drives the
corrective action system to address problems requiring immediate action and possible additional
long term action aimed at eliminating or reducing the likelihood of its recurrence.
3.2 A defined and documented problem solving leading to root cause identification and elimination is
applied for corrective action investigations.
4. PREVENTIVE ACTION
4.1 Data from corrective action investigations, customer feedbacks, employee suggestions and other
appropriate sources is use to identify the actions needed to eliminate the causes of potential
problems leading to an occurrence.
4.2 Investigating and eliminating the root cause of potential failure is a critical part of the continuing
improvement process.
4.3 Results of preventive action analysis and related recommendations are presented to the senior
management.

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 RETENTION OF RECORDS AND SPECIMENS
1. The laboratory staff must follow the retention period for records and specimens.
2. RECORDS

LIST OF RETENTION PERIOD BASED ON ITS CATEGORY

A. DOCUMENTS AND RECORDS
1. Analytical Systems and Quality Improvement Files
Active Storage Total Remarks
Annual Review of Policies,
Processes, and procedure 2 years 2 years
records
After equipment has
Equipment and Instrument
been returned /
Preventive Maintenance 2 years 2 years
rendered
Records
unserviceable
Inspection, Audit and
5 years 5 years
Assessment Records
Management Review Records 2 years 2 years
Method Manuals (Work
Instruction) & Laboratory 2 years 2 years
After procedure has
Worksheet
been discontinued
Method/Process Validation
2 years 2 years
Records
Quality Control Records 2 years 2 years
Qualification System
Assessment and Proficiency
Testing Records 5 years 5 years

(e.g., NEQAS)
Reagent, Materials and Supplies
2 years 2 years
Records
Specimen Rejection Records 1 year 1 year
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 Supplier Qualification Records 2 years 2 years
Waste Disposal Records 2 years 2 years
2. Clinical Laboratory Files
Clinical Laboratory Employee’s
2 years 3 years 5 years After updated
Signature Initials
Laboratory Test filled–out
Requisition Forms (Clinical 2 years 2 years
Laboratory Request)
After Date of Last
Record Book
Entry
a. General Laboratory Test
5 years 5 years
Results
b. General Patient Registry 5 years 5 years 10 years
3. Laboratory Test Reports
Clinical Laboratory 2 years 2 years
Medico–legal Permanent**
** Permanent records are those with enduring value and classified in the Records
Disposition schedule that have been selected for permanent preservation (National
Archives of the Philippines).

3. SPECIMEN

B. SLIDES, SMEARS, BLOOD AND OTHER BODY FLUIDS

1. Clinical Chemistry and Immunology / Serology
Other Body Fluids (Pleural/Peritoneal/Pericardial Fluid) 1 week, Refrigerated
Serum/Plasma 1 week, Refrigerated
2. Clinical Microscopy
24–hour Urine, aliquot/Random Urine/Stool 1 day, Refrigerated
3. Hematology
24 hours, Room
Anti–coagulated (Heparinized or EDTA) Whole Blood
Temperature
ABO Blood Typing (EDTA – Whole Blood and Serum) 7 days
24 hours, Room
Plasma for Coagulation Testing
Temperature

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 POLICY ON QUALITY ASSURANCE
1. INTERNAL QUALITY CONTROL PROGRAM
1.1 General Rules and Regulations
1.1.1 Quality control programs are set to ensure that the results generated and reported
are accurate and precise.
1.1.2 All laboratory personnel shall have a continuous competency program through their
attendance in conventions/seminars. The laboratory personnel shall file a copy of the
certificate on his/her file, as proof of attendance.
1.1.3 Procedure manuals must be available at all times in the laboratory.
1.1.4 Equipment are calibrated based on their scheduled calibration dates, and must be in
good working condition.
1.1.5 All laboratory personnel must have the skills and knowledge appropriate for their
tasks.
1.1.6 Recording of results in their designated logbooks
1.1.7 Cleaning before and after work is a must.
1.2 Pre-Analytical
1.2.1 Proper knowledge of laboratory staff in proper specimen collection, and able to
instruct patients properly.
1.2.2 Patient was correctly identified and prepared for sample collection.
1.2.3 Sample was labeled correctly and clear.
1.2.4 The request form matches the specimen.
1.2.5 The request form contains correct and clear contact details of the patient.
1.2.6 The specimen was transported appropriately to the laboratory.
1.2.7 The specimen was received in acceptable condition
1.3 Analytical
1.3.1 Reagents and test kits used were within expiry date.
1.3.2 Quality controls associated with the result were acceptable.
1.3.3 There were no flags on the analyzer’s results that need investigation.
1.3.4 If diluted, the final results were calculated correctly with the correct dilution factor.
1.3.5 Results are within the biological reference intervals.
1.3.6 Panic (critical) values are confirmed.
1.3.7 The results make clinical sense.

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 1.3.8 If applicable: previous patient results are available to assist with interpretation of
current sample’s result.
1.4 Post – Analytical
1.4.1 The report shows an appropriate result including test and result match for each test
requested.
1.4.2 Proper concentration units for results are used.
1.4.3 The decimal place is correct (if results have decimals).
1.4.4 The persons performing the tests are identified.
1.4.5 All results and documentation are legible.
1.4.6 The release of the results is dated and timed.
1.4.7 All results are logged into their respective logbooks
1.4.8 Proper storage of results and requests.

1.5 Quality Control of Equipment Assays

1.5.1 Quality Control (QC) are done daily. Values must be within the prescribed range
before any laboratory examination is done on patient’s specimens to ensure
accuracy and precision of results. Westgard rules and determination of possible
shifts and trends must be noted and immediate action must be done in cases of their
presence.
1.5.2 Westgard Control Rules:
1.5.2.1 12S – Warning sign. Once Control value fall outside the 2SD limits.
1.5.2.2 13S – One control exceeds the 3SD limits.
1.5.2.3 22S – Two control results outside the 2SD limits.
1.5.2.4 41S – Four consecutive control results exceed 1SD results
1.5.2.5 54S – The difference between the highest and lowest control results exceeds 4
SDs.
1.5.2.6 6 10x – Ten consecutive control results are on one side of the mean.
1.5.3 Levey-Jennings chart must be stored and filed for documentation.
1.5.4 Quality control reference materials must be filled for easy reference.
1.6 Quality Control of Specimens
1.6.1 Inspection of all specimens upon receipt and before testing will ensure that they
suitable for the requested examination.
1.6.2 Unacceptable specimen is not to be processed or accepted unless repeat collection
is done. If however such is to be processed, a remark or note will be written on the
report indicating that the specimen was accepted and processed as per ordering
physician’s request.
1.6.3 Patient information which includes the name, age, gender shall be written on the
tube and on the specimen container. Patient’s information on the tube and request
form should match.
1.6.4 Laboratory staff should strictly follow the policies written regarding specimen
handling rejection and storage.

2. PROCEDURE IN NATIONAL EXTERNAL ASSESSMENT IN CLINICAL CHEMISTRY,

HEMATOLOGY, PARASITOLOGY AND SEROLOGY BY THE DEPARTMENT OF HELTH

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2.1 The chief medical technologist must ensure that the laboratory actively participates in the
EQAS program provided by the National Reference Laboratories as a strict requirement for
the yearly renewal of laboratory’s license to operate (LTO)
2.2 Hematology
2.2.1 EQAS registration and payment must be submitted personally or electronically,
whichever is applicable, to the National Kidney and Transplant Institute.
2.2.2 Original receipt and copy of the registration must be submitted to the accounting
area of the clinic and photocopy must be filed within the laboratory files. Make sure
to receive a confirmation of registration.
2.2.3 Upon receipt of EQAS specimen, the attached detailed instructions must be followed.
The specimen must be treated as regular specimen in processing. The laboratory
staff must note the date of receipts and the detailed description of the specimen.
2.2.4 Entry of results online must be done before the deadline of submission, indicated in
the instructions attached with the specimen. Results must be log in the EQAS
logbook.

2.3 Chemistry
2.3.1 Chemistry EQAS registration is done online and payment can be made through bank
deposit, the receipt and other supporting files must be mailed to the Lung Center of
the Philippines. The NRL must be notified regarding the payment for the
confirmation.
2.3.2 A copy of the receipt and registration must be filed in the laboratory NEQAS file.
2.3.3 Make sure to receive a confirmation of registration approval.
2.3.4 Upon receipt of EQAS specimen, check for any tempering and/or the state of the
sample. Follow the instructions attached with the sample.
2.3.5 Chemistry EQAS is run monthly therefore receiving multiple sample of EQAS on a
one-time delivery is observed.
2.3.6 Every month an EQAS is run, it is run according to its number, and there is a monthly
submission of result online. The EQAS sample must be run as a normal specimen.
2.3.7 All results must be logged in the logbook for NEQAS results.
2.4 Parasitology
2.4.1 Parasitology EQAS registration from can be done online and follow the payment
instructions as it can change every year, to the Research Institute for Tropical
Medicine. The NRL must be notified regarding the payment for confirmation.
2.4.2 Original receipt and copy of the registration must be filed in the laboratory NEQAS
files.
2.4.3 Make sure to receive a confirmation of registration approval.
2.4.4 Upon receipt of EQAS, a set of instructions is attached and must be followed, the
specimen must be treated as regular specimen.
2.4.5 Follow the instructions in result submission
2.4.6 EQAS result must be recorded in the logbook.
2.5 Serology
2.5.1 Serology EQAS registration is done online and payment can be through bank deposit
addressed to San Lazaro Hospital SACCL.
2.5.2 Original receipt and copy of the registration must be filed in the laboratory NEQAS
files.

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 2.5.3 Make sure to receive a confirmation of registration approval.
2.5.4 Upon receipt of EQAS, a set of instructions is attached and must be followed, the
specimen must be treated as regular specimen.
2.5.5 Follow the instructions in result submission
2.5.6 EQAS result must be recorded in the logbook
2.6 The laboratory staff on duty must follow the instructions attached with the EQAS, upon
receiving.
2.7 NEQAS must be performed within the laboratory and using the registered laboratory
equipment.
2.8 Sending – out of NEQAS sample is strictly prohibited.
2.9 In cases of two or more consecutive failures in EQAP, the laboratory shall comply with the
guidelines set by the respective NRLs.
2.10 Recent EQAP certificates must be posted within areas that are visible to patients.
2.11 Previous EQAP certificates must be stored and filed.

PROCEDURE ON REFERRAL AND OUTSOURCING OF EXAMINATION TO OTHER

LICENSED CLINICAL LABORATORY
1. All laboratory tests that are beyond the capability of Cavite Diagnostic Stroke Care Center Inc., are
outsourced to a licensed tertiary Clinical Laboratory.
2. To start sending specimen to a send-out laboratory, a Memorandum of Agreement (MOA) is secured.
The laboratory of choice must provide a copy of its certificate of LTO issued by the DOH, together with
its company profile, pricelist and available tests.
3. Proper handling and storage of specimen including proper collection of specimen is within the
responsibility of the assigned medical technologist of the company, until the assigned courier gets the
specimen.
4. Specimen management:
4.1 All specimen must be labeled correctly by the assigned medical technologist. It includes the
patient’s name, age and gender.
4.2 Serum: Separate the serum from the clotted blood, and transfer in a clean and sterile test tube. A
minimum of 2mL serum is needed. Seal the tube, by inserting the rubber top.
4.3 Whole Blood: EDTA or citrated tube.
4.4 Urine: collected in a sterile, clean, and screw cap. The container must be filled ¾ of its capacity.
4.5 Stool: collected in a sterile, clean, and screw cap. FOBT tests are not allowed to be sent out.
4.6 Label the test tube/container twice. First, label the tube directly using a marker. Second, is using a
micro pore tape and label it and stick it to the side of the tube, not overlaying the first label. The
label should include the patient’s name, age and gender.
4.7 Prepare the request form from the send-out laboratory, fill up all necessary information.
4.8 All tubes/container must be properly secured and taped to avoid leakage.
5. Shipping regulations
5.1 Samples are placed in a biohazardous transport bag and a folded requisition form is placed in the
bag's outer pocket. The bag is then placed in a third container, like an insulated bag (provided by
the courier), and labeled with a biohazard sticker.
5.2 Message the courier assigned to the laboratory by the send-out lab, and wait for his/her
confirmation.
5.3 The specimen is agreed to be pick up within one hour upon receipt of confirmation message from
the courier. If it will take longer, the specimen must be kept in the refrigerator.
6. Quality management

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 6.1 Log the send-out specimen in its designated logbook. Note the patient’s name, age, gender, tests,
time and date of collection, courier’s name and time of collection of the courier.
6.2 A receipt is given, and must be kept in its designated folder.
6.3 Make sure that the required test can be provided by the send-out laboratory.
6.4 Specimen integrity is paramount in providing the clinician with a viable laboratory result. The
specimen must be send-out quickly.
6.5 Track delayed results and inform the send-out laboratory for proper endorsement.
6.6 All results are emailed to the laboratory’s official email address: cdsccilab@gmail.com. Culture and
sensitivity results are of hard copy and is given by the courier.
7. Patient communication
7.1 Patient’s requiring send-out test(s) must be informed of the released date. All results are released
the next day, unless stated otherwise.

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