PROVIDENCE

Medical Laboratory

MANUAL OF STANDARDS ON QUALITY MANAGEMENT SYSTEM IN THE

CLINICAL LABORATORY

In Partial Fulfillment

Of the Requirement for the Subject

Laboratory Management

Presented to

Jesus D. Villafranca, PhD.

May, 2022
 APPROVAL SHEET

This Manual of Standards on Quality Management System in the Clinical Laboratory

named “PROVIDENCE” prepared and submitted by:

Dela Llarte, Mark

Odtohan, Patricia Mae H.

Santiago, Christian P.

Uy, Illana Phillys T.

In partial fulfillment of the requirements in the Laboratory Management subject, had

been reviewed and guided by:

Jesus D. Villafranca, PhD

Adviser, College of Medical Technology

Approved on with the grade of:

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 CERTIFICATE OF ORIGINALITY

We hereby declare that this laboratory manual entitled “PROVIDENCE”

submitted as requirement for the degree of Bachelor of Science in Medical

Technology at the Metropolitan Medical Center – College of Arts, Science and

Technology embodies the result of original and scholarly work carried out by the

undersigned.

This is also to certify that this is our own work and original intellectual content

that, to the best of our knowledge and belief, it contains no materials previously

published or written by another person nor material to which to a substantial extent

has been accepted for award or any other degree or diploma of a university or other

institute of higher learning, except where due acknowledgement is made in the text.

Dela Llarte, Mark

Odtohan, Patricia Mae H.

Santiago, Christian P.

Uy, Illana Phyllis T.

Jesus D. Villacranca, PhD

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 INTRODUCTION

The “PROVIDENCE” was the name of laboratory envisioned by a group of

students in Metropolitan Medical Center in their early years who shared the same

goal on kept an enemy at bay with arsenal weapons that only true guardians of

science possess; an eye for detail, an immense thirst for knowledge and a willing

heart to help everyone regardless of disease state, ethnicity, race, religion or sex.

Equipped with a selfless attitude, compassionate demeanor, and desire to improve

the quality of life, “PROVIDENCE” was established in Rodriguez, Rizal.

“PROVIDENCE” offers a wide range of valuable diagnostic services. With

highly trained personnel and the emergence of art and technology, the laboratory is

true to its claim of promoting the delivery of safe, effective, informed care for patients

undergoing diagnostic tests and depicting the historical aspects of the Philippines

that makes it more distinct from other laboratories nationwide. “PROVIDENCE”

ensures to be a bridge on giving Filipinos quality care they deserve.

For 3 years of service, PROVIDENCE had been successful.

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 40 m

Clinical Chemistry
Waste Room CR
Room (10m)
EXIT

EXIT Hematology (10m)

Pathologist Room (10m) Clinical Microscopy

Room (10m)

Immuno-Serology Room
(10m)

Holding/Waiting Area

HIV Testing Room (10m)

OR (6m)

Lobby

Counselling (8m) Entrance

40 m

Figure 1. Laboratory Floor Plan

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 Mission, Vision, Objectives

Vision

PROVIDENCE MEDICAL LABORATORY is recognized nationally as a

community laboratory that promotes quality health care, responsiveness, is one of

the most trusted healthcare partners.

Mission

PROVIDENCE MEDICAL LABORATORY collaborates with communities and

is always constantly striving to be an instrument for the effective and efficient

delivery of laboratory services, as well as to promote the improvement of Filipino

health through the advancement of laboratory systems.

Objectives

Providence Medical Laboratory aims to:

• Become more competent and to establish a harmonious relationship with the

community as well as to ensure a high standard of patient care.

• Live the term equity, free of bias and in the best interests of not becoming a tool

of evil deeds.

• Be held responsible for the quality and integrity of laboratory services provided.

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 Objectives for HIV Testing & Counselling

PROVIDENCE aspires to provide HIV testing and counseling of the highest

quality, together with a comprehensive package of HIV-related prevention, treatment,

care, support services, and antiretroviral medicine, to all those who need it.

PROVIDENCE strives to act in the patients' best interests. There must also be

equal efforts to limit any risk to patients. The clinical laboratory ensures that sufficient

resources are available to optimize favorable results, and that all healthcare staff had

received proper training.

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 ACKNOWLEDGMENTS

Presentation, inspiration, and motivation have always been important aspects

of any venture's success. This project is becoming a reality thanks to the generous

support and assistance of many people. They would like to express their heartfelt

gratitude to the following individuals:

First and foremost, praise and thanks to the Almighty God for providing them

with knowledge, wisdom, strength, and guidance throughout the process of finishing

this laboratory manual.

Second, Dr. Jesus D. Villafranca, their mentor and adviser, for being

considerate, guiding them through the process, and sharing his knowledge and

sincere advice;

Third, our classmates, for their incredible teamwork that inspired them to do

more, and for their perseverance in completing this project;

Finally, they want to thank their families for their encouragement and support

in pushing them to finish this project.

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 TABLE OF CONTENTS
Page

APPROVAL SHEET 2

CERTIFICATE OF ORIGINALITY 3

INTRODUCTION 4

MISSION, VISION, OBJECTIVES 6

Objectives for HIV Testing and Counseling 7

ACKNWOLEDGEMENTS 8

MANAGEMENT RESPONSIBILITY

1.1 Management Commitment 13

1.1.1 Compliance with Legal Regulatory Requirements_______________ 15

1.1.2 Vision, Mission, Quality Policy 16

1.1.3 Quality Manual 17

1.2 Leadership 17

1.3 Organizational Structure and Function 19

1.4 Quality and Strategic Plan 22

1.5 Professional Ethic and Conduct 23

1.6 Provision of Resources (Budget) 25

1.7 Management Review 26

RESOURCE MANAGEMENT

2.1 Human Resource Management 28

2.2 Management of Physical Facilities 45

2.3 Equipment and Instruments 45

2.4 Reagents, Controls, Standards, Glassware and Supply 45

2.5 Management of Supplies 48

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SERVICE DELIVERY

3.1 Customer Needs and Requirements 51

3.2 Contract 51

3.3 Administrative Procedure 53

3.4 Technical Procedure 54

3.5 Clinical Consultative services 131

MONITORING PERFORMANCE

4.1 Internal Quality Control (ICQ) Program 147

4.2 Performance Indicators 147

4.3 Patient Satisfaction 150

4.4 Resolution of Complaints 151

4.5 Internal Quality Audit (IQA) 152

4.6 External Quality Assessment Surveys (EQAS) 154

QUALITY IMPROVEMENT (QI) ACTIVITIES

5.1 Management of Quality Improvements Activities 162

5.2 Identification of Problems and Poor Delivery Services 162

5.3 Continuous Quality Improvements (CQI) (Problem-Solving) 162

5.4 Implementation, Monitoring and Institutionalization 163

5.5 Primary Preventive Measures 164

5.6 External Quality Assessment (Accreditation) 167

INFORMATION MANAGEMENT

6.1 Customer Relations 169

6.2 Communication 171

6.3 Documentation and Record Control 173

6.4 Laboratory Information System 176

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6.4.1 Requests for Laboratory Examinations 176

6.4.2 Delivery of Results for Laboratory Examinations 177

6.4.3 Workloads Report & Other Statistical Report 178

ENVIRONMENTAL MANAGEMENT AND BIOSAFETY

7.1 Sanitation and Cleanliness 180

7. 2 Orderliness and Labeling 182

7.2.1 Labeling 182

7.2.2 Segregation and Storage 183

7.2.3 Disposal of Waste 184

7.3 Solid Waste Management 185

7.4 Liquid Waste Management 185

7.5 Fire Safeties 197

7.6 Accidents and Emergency Preparedness 201

BIBLIOGRAPHY 205

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GROUP OF STANDARDS NO.1
MANAGEMENT
RESPONSIBILITY

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 1. Management Responsibility

Management is responsible for overseeing overall lab operations, developing

procedures to ensure the safety, security, quality, and accuracy of results, designing

and performing test procedures, analyzing requests for tests and equipment, dealing

with administrative and management issues, consulting with principal investigators,

and assisting with budgeting.

Our laboratory is responsible for following the guidelines that will be proposed

for a clinical laboratory pertaining to qualifications, liable services, and that will be

applicable for the enhancement of management and quality of services.

Fundamental Management Responsibilities

The following are the primary responsibilities of branch managers:

a) Oversee the planning, execution, and monitoring of all laboratory activities.

b) Lead and manage the laboratory team in your area of responsibility.

c) Organize work and the work area to improve service performance.

d) Ensures that all preventive maintenance functions are intact and functioning

properly.

e) Assumes responsibility for ensuring that various functions are carried out within

the confines of the workday

f) In charge of creating and implementing policies and procedures in various

departments, including human resources, finance, and customer service

g) Carry out employee scheduling.

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Employees are accountable for

a) Ensures that all services are performed correctly and in accordance with quality

standards.

b) On the job, you are responsible for all activities.

c) Ensures the safety of himself and his coworkers.

d) Work should be separated from personal matters.

e) Give your all-in terms of performance and customer satisfaction to management

and customers.

f) A role model for honesty, punctuality, and kindness.

1.1 Management Commitment

Management must demonstrate its commitment to the development and

implementation of the quality management system, as well as its ongoing

effectiveness, by:

a) Communicating to the organization the significance of meeting customer,

statutory, and regulatory requirements,

b) Developing a quality policy,

c) Ensuring the establishment of quality objectives,

d) Carrying out management reviews, and

e) Ensuring resource availability.

The clinical Laboratory, in carrying out this responsibility as a diagnostic

laboratory, provides clients with all-inclusive service. The management is hereby

committed to following procedures in order to maintain the highest quality of service

that should be rendered to clients with integrity.

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 a) Ensuring that clients receive high-quality service, performance and

confidentiality

b) The management is fully responsible for all aspects of the contract business,

whether to its employees or clients

c) The management is fully committed to the National Standards as per

Department of Health's rules and regulations (DOH).

d) The laboratory's management is dedicated to good professional practice to

ensure the clients' safety

e) The management is committed to learning from the lessons and experiences

gained by themselves and others to improve their performance

f) The management is dedicated to constantly improving the service and the

future effectiveness of the management system

g) The management team is dedicated to raising awareness of best practices in

methodologies, products, services, and the most recent innovations.

h) The administration ensures fairness, humanity, and confidentiality.

i) The management assures that they are open and honest with their clients, both

parties' safety and good communication.

1.1.1 Compliance with Legal Regulatory Requirements

Clinical laboratory regulations ensure that the PROVIDENCE MEDICAL

LABORATORY will follow clinical laboratory testing rules, regulations, and standards

such as performing professional laboratory work with specimens following established

clinic procedures and performing chemical and biological tests on patient specimens

for medical diagnosis accompanied by legal requirements such as license to ensure

regulatory compliance in a clinical laboratory.

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 PROVIDENCE MEDICAL LABORATORY is dedicated to providing a safe and

secure environment and for laboratory management success. It suggested

demonstrations to comply with federal and state regulations to encourage these.

Compliance can be achieved and demonstrated by:

a) Developing systematic and efficient compliance policies.

b) Educating employees on company policies.

c) Thinking beyond the situation to issues that may turn into potential violations,

and ensuring that proper procedures are in place to address the issues

immediately.

d) Screening and monitoring employees.

e) Implementing compliance-related communication, education, and training

f) Conducting investigations into internal and external factors, as well as

corrective measures

1.1.2 Vision, Mission, Quality Policy

For the sake of consistency in developing an accountable high-quality

laboratory system, the clinical laboratory Head Manager must monitor the flow of

progress and improve for sustainability, attainable, valuable, and

advancement Quality indicators.

VISION

PROVIDENCE MEDICAL LABORATORY is recognized nationally as a

community laboratory that promotes quality health care, responsiveness, and is one

of the most trusted healthcare partners.

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MISSION

PROVIDENCE MEDICAL LABORATORY collaborates with communities and

is always constantly striving to be an instrument for the effective and efficient delivery

of laboratory services, as well as to promote the improvement of Filipino health through

the advancement of laboratory systems.

OBJECTIVES

Providence medical laboratory aims to:

a) To become more competent and to establish a harmonious relationship with

the community as well as to ensure a high standard of patient care

b) To live the term equity, free of bias and in the best interests of not becoming a

tool of evil deeds.

c) To be held responsible for the quality and integrity of laboratory services

provided.

1.1.3 QUALITY MANUAL

The PROVIDENCE MEDICAL LABORATORY is responsible for developing a

safety manual ensuring that the practitioners who order laboratory tests for their

patients are in possession of comprehensive, up-to-date information about laboratory

testing, policies, and procedures that help to improve the health and well-being of the

people they serve, and raise the quality of life for all involved.

A quality manual must provide the laboratory's leadership, personnel, and

accreditors with a description of how the laboratory intends to ensure quality by

practicing good quality management and meeting regulatory, accreditation, and

customer requirements.

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1.2 LEADERSHIP

The laboratory requires a management and leadership style that strikes a

balance. As a result, the management must appoint professionals to manage and

supervise the laboratory and its sections. Thus,

a) The laboratory's Director is a duly licensed physician who has been certified by

the Pathology Board of the Philippines

b) Each section is led by a Chief Medical Technologist who has extensive

experience in the field. Postgraduate education, training, or a continuing

professional development program education (CPE) in the discipline over which

he has authority.

For the betterment of the management, PROVIDENCE MEDICAL LABORATORY

ensures that a leader has exceptional abilities and knowledge and will be attributed to

ensure the laboratory's reputation and the safety of both the patients and of the

employees.

PROVIDENCE MEDICAL LABORATORY leaders must have the following

qualifications:

a) Bear the lion's share of the responsibility for ensuring the safety of everyone in

the laboratory environment. They organize safety training, ensure that there are

always clear safety guidelines, and promote a clean, organized, and safe

working environment.

b) Are in charge of determining the best path for the laboratory to take in order to

get the outcomes that will exceed patients' expectations.

c) Must be able to communicate effectively with their employees as it is necessary

and vital to maintain high team morale and a pleasant working environment.

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 d) Should always be prepared for the unexpected. And have the thought that

everything is five steps ahead of you.

1.3 ORGANIZATIONAL STRUCTURE AND FUNCTION

PROVIDENCE MEDICAL LABORATORY developed an organizational plan to

improve the laboratory's style, size, and operation.

Organizational Structure

An organizational chart will be used to present the structure so that it aligns and

connects clinical laboratory components to maximize performance it will depict the

management flow in the organization.

Functions, Duties, & Responsibilities

The Laboratory Director is in charge of the clinical laboratory's overall

operation and its administration, which includes the hiring of qualified personnel,

equipment, employee, patient, and workplace safety.

The Clinical Pathologist is in charge of all special divisions in the clinical

laboratory. He/She are interested and concerned in the diagnosis, treatment, and

prevention of these diseases.

The Chief Medical Technologist manages and supervises a wide range of

services such as chemical, bacteriologic, and microscopic examinations. He/She

supervise the Medical Technologists’ and Technicians' performance as the Chief.

They can perform more advanced and specialized laboratory and instructional work

that requires the use of more varied and complex procedures, or they can be in charge

of the accuracy of results and administrative control of technical standards in the unit

supervised.

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 A Medical Technologist (MT) or Clinical Laboratory Scientist (CLS)

performs comprehensive tests, procedures, experiments, and analyses to provide

data for the diagnosis, treatment, and prevention of diseases. Their responsibilities

also include searching for specific microorganisms such as bacteria or parasites.

A Medical Laboratory Technician collects data in order to assist others.

Colleagues in the diagnosis of a patient. They are in charge of labeling, sorting, and

checking specimens, as well as entering all information into the computer system.

They also make the workplace safe for other employees and patients by keeping it

clean and ensuring that no medical equipment is contaminated.

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 Juvannie H. Odtohan
PATHOLOGIST

Daryll Jay S. Maghinay

LABORATORY DIRECTOR

Illana Phyllis T. Uy
CHIEF MEDICAL
TECHNOLOGIST

Mark Dela Llarte Patricia Mae H. Odtohan Christian P. Santiago

MEDICAL TECHNOLOGIST MEDICAL TECHNOLOGIST MEDICAL TECHNOLOGIST

Figure 2. Organizational Structure of Providence Medical Laboratory.

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1.4 QUALITY AND STRATEGIC PLAN

The PROVIDENCE MEDICAL LABORATORY was pushed into a Quality and

Strategic Management Plan to various practices in various fields. Strategic planning

is provided to the clinic in order to improve the services provided to its clients and

employees. This was used to keep the clinic growing and to make future

improvements.

a) To maintain quality assurance, the laboratory was outfitted with quality

assurance equipment for the safety of the laboratory.

b) Laboratory equipment and chemical reagents are provided by the Department

of The Industry and its permit were approved.

c) All of the machines in our clinic meet and approved by the International

Standards and have a prior permit to operate it

d) We are a tax-free laboratory with no outstanding taxes.

e) The laboratory has no outstanding liabilities and has the authorized to conduct

business.

Strategic Management

a) As part of the strategic plan, the laboratory improved its promotional campaign

plan.

b) SWOT analysis is used extensively in the laboratory to determine planning

strategy.

c) The laboratory employs a single business strategy for multiple purposes.

d) To improve the marketing strategy, the strategic plan was reversed to improve

the Laboratory goals and sales targets.

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 e) The laboratory was purposefully left intact with a planning strategy to keep the

laboratory's efficiency and service performance

Quality Objectives

PROVIDENCE MEDICAL LABORATORY ensures the quality of clinical

laboratories and policy is committed to providing services that meet and exceed

patient expectations. To maintain the laboratory quality management system, patients

expect high-quality health care and low-cost medications.

The laboratory and its employees are committed to continuous improvement.

Process control and variability reduction to improve service and product quality,

rehabilitating manufacturing technology, machines, and skills. To make the laboratory

well-known for providing high-quality health care and services on a consistent basis

as well as review for its success.

1.5 PROFESSIONALS ETHICS AND CONDUCT

PROVIDENCE MEDICAL LABORATORY will ensure that professional

healthcare is provided. Personnel act in accordance with the ethical standards of their

professions.

Codes of Conduct

PROVIDENCE MEDICAL LABORATORY shall establish codes of conduct as

the foundation for its operations of healthcare personnel to adhere to the profession's

prescribed standard of practice.

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Professional Codes of Conduct must be drafted in accordance with the

following principles of ethics:

a) Ensure the accuracy and precision of results when performing numerous tasks

and various procedures for disease diagnosis. Each healthcare professional

must always be aware of the accuracy and precision of the testing process and

its results.

b) Professionalism must be demonstrated in accordance with professional codes

of conduct. Every member of the healthcare team should be aware of all laws

and regulations and should not use them outside of their scope.

c) Rapport is characterized by a high level of understanding and trust. To be

effective, healthcare personnel must maintain positive relationships with their

patients and be capable of communicating with them.

d) Healthcare personnel must always maintain a professional appearance to avoid

looking bad. They must be presentable in relation to their work.

e) Maintain the confidentiality of all patients' information as well as all records.

Unless the patient gives consent to make the information available.

If there are any controversies or ethical issues within the clinical laboratory,

they must be resolved as follows:

a) Misinterpretations of Medical Technologists' Work If ever a healthcare worker

or medical technologist makes mistakes in their work, Reasonable steps must

be taken to correct or at least mitigate the problem, error, or misinterpretation.

b) Conflicts between ethics and law, rules and regulations Healthcare personnel

should take appropriate steps to address and clarify the conflict.

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1.6 PROVISION OF RESOURCES (Budget)

The PROVIDENCE MEDICAL LABORATORY will manage and operate widely

materials/resources of the specified standard, including requirements and efficiency

to guarantee customer satisfaction

Inventory records must be detailed and well-organized. In the laboratory,

materials such as instruments, equipment, and reagents are provided. It should be

made easier for laboratories to ensure quality and standard services that are effective

for leading a laboratory

The guarantee for the resources must be monitored on a regular basis.

Providing a notice, due to organized and detailed needs, must be liable for the

laboratory's needs.

1.7 MANAGEMENT REVIEW

PROVIDENCE MEDICAL LABORATORY must establish a standard to ensure

the laboratory's services are sustainable and effective, addressing potential

assessment needs and objectives as well as procedures for the assessment of patient

attention. Additional recommendations may be made after determining and evaluating

the laboratory's quality system.

Management review will be held accountable for:

a) Preferences and changes in products or services;

b) Changes in the importance of customer feedback and other control parties with

an interest;

c) Audit findings and results;

d) Management review of proposed legislation and management review;

e) Evaluation of actions taken and a required protocol;

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 f) Each report's policies, goals, and objectives in relation to the health inspection

division.

The Head of the PROVIDENCE MEDICAL LABORATORY shall maintain and

implement a continuous quality system for improvement and at least one management

review.

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GROUP OF STANDARDS NO. 2
RESOURCE MANAGEMENT

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2.1 Human Resource Management

In PROVIDENCE MEDICAL LABORATORY, it is crucial that a health care

institution be well manned. The HR manager plans and executes the selection of

qualified applicants for these jobs. The tasks of HR management at the Laboratory

include keeping the service records of all workers, including leave and other benefits,

as well as processing different staff-related and travel-related concerns. Providing

chances for professional growth and enhancing a health care organization's capacity

to provide excellent health care services and enhance the overall health outcomes of

patients.

2.1.1 Staffing

The Laboratory Director should create high standards, be well-trained, listen

to their employees, and be capable of making crucial judgments. The PROVIDENCE

MEDICAL LABORATORY is staffed with competent, dependable, knowledgeable,

accountable, clever, devoted, and well-trained healthcare experts who are equipped

to execute all services.

2.1.2 Personal Recruitment Selection

The management of the PROVIDENCE MEDICAL LABORATORY should

complete the processes for employing healthcare professionals who are well-trained

and competent for the laboratory's strategic goals.

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HIRING

The Owner, Pathologist, or any other approved representative is capable of

undertaking the examination and screening of applicants for clinical laboratory

employment.

The following documents must be submitted by applicants.

a) Updated resume with 2x2 picture

b) College Diploma

c) Medical Certificate

d) Photocopy of Birth Certificate

e) Photocopy of College Diploma

f) Photocopy of PRC License ID & Certificate

The Laboratory Director, Pathologist, or authorized representative must conduct a

pre-interview and an initial screening interview with applicants to ensure that they are

dedicated, intellectually equipped, and trained for the clinical laboratory's healthcare

services.

A 45-day training on the various areas of the clinical laboratory will be

conducted by the pathologist and chief medical technologist.

2.1.3 Job Description and Contract

Job descriptions and contracts should include enough information about each

healthcare worker's roles and responsibilities in the clinical laboratory. Each

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healthcare worker in the clinical laboratory should develop their own job descriptions

and contracts that properly outline their responsibilities.

Clinical laboratory professionals have the following duties and responsibilities:

Laboratory Director

The Laboratory Director holds a Bachelor's Degree in Laboratory

Administration and has three (3) to five (5) years of management experience.

As a Laboratory Director, he or she is responsible for ensuring that:

a) Employees work in an environment free of physical, chemical, and biological

risks, and biohazard regulations are followed.

b) Employees are capable of being promoted.

c) Establishes the standards for establishing a Quality Assurance Program, which

includes quality control and improvement activities;

d) The laboratory's physical and environmental conditions are

e) Suitable and adequate for the tests to be carried out;

f) The procedure handbook is updated with new test protocols. and

g) Personnel will follow

h) The obligations and duties of each employee are written down.

Pathologist

The Pathologist is a duly licensed physician who specializes in laboratory

medicine, or the gross and microscopic examination and interpretation of tissues,

secretions, and excretions of the human body. He or she verifies the accuracy of

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laboratory tests and interprets the results to aid in the diagnosis and treatment of

patients.

As a Pathologist, he or she must:

a) Provide a safe environment for clients in a timely manner. Fire, choking, and

other emergency circumstances.

b) Solve challenges, think critically, and make great clinical decisions in

c) Evaluate patient and diagnosis planning and the performance of all clinical

workers in the laboratory as well.

d) Examine all of the employees' hiring, interviews, orientation, and promotions in

the clinical laboratory.

e) Establish disciplinary measures for all healthcare workers as stated in the

clinical laboratory's policy.

Chief Medical Technologist

The Chief Medical Technologist must have a Bachelor's Degree in Medical

Technology/Medical Laboratory Science and have passed the Professional

Regulation Commission's (PRC) Medical Technologist Licensure Examination, as well

as significant experience as a Medical Technologist in the clinical laboratory, including

experience in the area of assignment; or any equivalent combination of training and

experience. Candidates for this post must have the following qualifications: broad

knowledge of medical technology principles, procedures, materials, equipment, and

techniques at the time of appointment.

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 He or she must do the following as a Chief Medical Technologist:

a) Serve as Chief Technician for the clinical laboratory's entire laboratory sector;

supervise and participate in all standard clinical laboratory tests and

procedures;

b) Arrange junior technicians' schedules, aid with methodological revisions, and

manage the maintenance of laboratory records and reports.

c) Participate in the hiring and training of staff, as well as the ordering of supplies.

d) Consult with the Laboratory Head to resolve difficult technical issues as well as

interpersonal conflicts among colleagues.

Medical Technologist

A medical technologist is a person who works in the medical field. A bachelor's

degree holder in Medical Technology/ Medical Laboratory Science, passed the Medical

Technologist Licensure Examination issued by the Professional Regulation Commission

(PRC), and formal training and work experience are required.

As a medical technologist, he or she is responsible for:

a) Creating and tracking programs to assure data accuracy.

b) Examining fluid slides under a microscope.

c) Analyzing blood or urine for hazardous substances.

d) Examine lab reports for errors.

e) Operating and calibrating equipment.

f) Delivering test findings to doctors, scientists, and patients.

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Clinical Laboratory Technician

A laboratory technician is someone who does not have a degree in the field.

Bachelor of Science in Medical Technology/Medical Laboratory Science, but certified

to help medical technologists in the clinical laboratory after passing the Civil Service

Examination.

As a Laboratory Technician, he or she is responsible for:

a) Assisting

• Professionals with patient instruction and preparation for collecting blood

• In the distribution of results to patients

• All medical technologist in making disease diagnosis and

• All patients contributes with their requirements

b) Making it easier to patients to submit samples.

c) Setting up and disinfecting the laboratory equipment.

d) Disposing safely chemicals and waste products.

2.1.4 Personnel Orientation and Induction

Orientation and induction are required for all healthcare staff pertaining to

roles, policies, and procedures in the laboratory. It is critical since this procedure will

allow them to become acquainted with their new working environment.

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 Any authorized Pathologist, Chief Medical Technologist, or other experts. In

the clinical laboratory, the representative is in charge of orienting newly hired

applicants, which includes:

General Introduction

a) Brief history of the organization

b) The organization's mission, vision, and goals

c) Organizational Policies and Procedures

Job Specific

a) A tour of the laboratories

b) Introduction to the work environment

c) Explicitly stating the working hours/shift

d) Explicitly stating the training techniques and expectations

e) Explicitly describing the performance evaluation

f) Explicitly describing the employee handbook

2.1.5 Work Schedule

The schedule of duties for all healthcare employees at Providence Medical

Laboratory will be eight (8) standard working hours, Monday through Saturday, from

9:00 a.m. to 6:00 p.m.

Every Sunday of the week is considered a rest day for all healthcare

professionals at Providence Medical Laboratory, regardless of whether the

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government has enacted regular or exceptional holidays. During their shift, staff at

the Providence Medical Laboratory will get a one (1) and a half hour break.

Table 2.1

SCHEDULE OF BREAKS

BREAKS DURATION

Morning Breaks 30 minutes

Lunch Break 30 minutes

Afternoon Break 30 minutes

Employees are free to utilize their break as they like, but they must adhere to

certain guidelines. They must not exceed the one (1) hour time limit set by the

company.

TIME KEEPING

There will be a fifteen (10) minute grace period for late employees, with three

(2) pesos removed from their pay for each minute they are late. Employees that come

early for their duty will be compensated with two (2) pesos each minute.

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UNDER TIME WORK

The Providence Medical Laboratory is open from 9:00 a.m. to 6:00 p.m.

Employees that leave their shift before 6:00 p.m. are deemed to be working under

time. For it to be valid, it must be accompanied by a justified situation such as illness,

the death of a family member, or an emergency, and it must be approved by the

Laboratory Director, Pathologist, or any other authorized individual present in the

clinical laboratory.

OVERTIME WORK

Overtime work is defined as work completed for more than eight (8) hours each

day.

In the following emergency situations, employees may be obliged to work overtime:

a) When it is required to avoid the loss of life or property, or in the event of an

emergency

b) A real or prospective emergency in the community, such as a catastrophic

accident, fire, flood, typhoon, earthquake, pandemic, or other disaster or

calamity, poses an immediate threat to public safety.

c) When the country is at war, or when the Department of Health has declared a

national or municipal emergency (DOH)

d) When the completion or continuation of work begun before the eighth hour is

required to avoid substantial impediment or prejudice to the employer's

business or operations.

36 | P a g e
 e) Every employee at Providence Medical Laboratory is guaranteed to be paid for

overtime work, with at least a 25.00% increase in their compensation (25

percent).

2.1.6. Personal Performance Appraisal and Promotion

The annual review will be conducted by the Providence Medical Laboratory.

Each member of the healthcare team is evaluated in order to enhance their

performance. A performance appraisal is a recurring and systematic process that

attempts to evaluate an employee's work performance as well as their degree of

productivity. This may take into account the employees' numerous achievements,

accomplishments, shortcomings, and strengths in order to assess overall results.

A promotion at the Providence Medical Laboratory is not just a method to give

an employee greater responsibility, but it's also a great approach to enhance employee

enthusiasm and morale. Employees must be promoted through a suitable process that

is fair to all and unbiased.

The following are the criteria that influence an employee's promotion:

a) Performance;

b) Length of service (seniority);

c) Merit & ability;

d) Educational/Technical qualifications;

e) Assessment of potential;

f) And Training.

37 | P a g e
 The Laboratory Director should not promote personnel based on their feelings

rather than their performance; this conduct may have an impact on the clinical

laboratory.

2.1.7. Staff Training and Education

To keep the Providence Medical Laboratory's high-quality care. All healthcare

personnel' abilities will be enhanced and developed through training and education,

ensuring high performance and professionalism in the laboratory. The Providence

Medical Laboratory agreed to send its employees to training. Seminars for continuing

education and skill improvement in Medical Technology practice. This activity will be

reported to the clinical laboratory's owner for approval, and a budget will be set up.

A total of twelve thousand pesos (12,000.00) will be set aside for the project.

Providence Medical Laboratory will gain from field training and development, as well

as improved knowledge and abilities in testing methods. Staff applications for training

or seminars should be submitted at least two (2) or one (1) week prior to the scheduled

training. If not, enough employees can accommodate the PML's services, the

Laboratory Director will not approve the personnel attending the training or seminars.

2.1.8. Personal Policies, Discipline, & Termination

Personal rules are designed to guarantee that everyone at the Providence

Medical Laboratory is treated fairly and equally, regardless of race, creed, color, or

sexual orientation. Discipline will be strictly enforced at the Providence Medical

Laboratory. If the penalties or offenses are repeated, the penalty or disciplinary action

will be increased.

38 | P a g e
 The following actions done inside the TLC will result to suspension:

a) Out of post Alcohol intoxication inside the clinical laboratory

b) Tardiness/Late

c) AWOL (ABSENCE WITHOUT LEAVE)

d) Insubordination

e) Eating in the post

f) Gambling

Offenses/Penalties Subject to the Employees:

Table 2.2

OFFENSE/PENALTIES

OFFENSE PENALTIES

1st Offense Five (5) days salary deduction

2nd Offense Two (2) weeks suspension without pay

3rd Offense One (1) month suspension without pay

4th Offense Termination of Contract

RESIGNATION

The employee should send a resignation letter to the Laboratory Director. The

employee's departure date will be determined by the terms and conditions stated in

the resignation letter, as well as the customary notice period of thirty (30) days. On

39 | P a g e
his/her last day of work on the agreed-upon day, the employee will be issued a

relieving letter and will be relieved from his/her duties at the close of the working hours

of the day mentioned in the relieving letter, subject to his obtaining clearance from the

departments listed in the No Objective Certificate Form and handing over the charge

and property in his possession to the person named in the relieving letter.

TERMINATION

If he or she is disciplined, he or she will be given an explanation of the penalty

imposed and will have the ability to appeal the finding and penalty. All employees are

required to conduct themselves in a manner that is appropriate and acceptable in the

workplace. For improper behavior, disciplinary action, including firing, may be taken.

The following are examples of unacceptable behavior:

a) Falsifying time sheets, employment records, or other institutional records;

b) Safety rules or recognized safety practices are broken;

c) Bringing intoxicants or narcotics into the institution's premises, consuming

intoxicants or drugs, possessing intoxicants or drugs. Possession of intoxicants

or narcotics, or being under their influence on at any time on the premises.

d) Disruptive behavior, horseplay, harassing of coworkers, or on-premises use of

harsh words;

e) Repeated tardiness or absences, as well as absences without prior notice to

the supervisor or without a good explanation or inability to attend work.

40 | P a g e
2.1.9. Personnel Records

Personnel records are kept so that policies and procedures can be developed

and reviewed. Personnel records provide complete information about all employees,

including their name, date of birth, marital status, academic qualifications, professional

qualifications, previous employment details, and so on.

The following are some suggestions on what documents an employer should keep in

an employee's personnel file:

About Employment

a) Job Application

b) Resume

c) Position Job Description

d) Employment & Education Verification

e) Emergency Contact Information

f) Any contract, written agreement, receipt, or acknowledgment between the

employee and the employer

Employee Performance Development

a) Copies of any performance appraisal

b) Employee self-assessments

c) Disciplinary action reports

d) Training records & requests for training

41 | P a g e
Employment Termination Records

a) Final accounting for all aspects of the employee's employment

b) Employee resignation letter

2.1.10. Staff Meeting and Communication

Regular meetings of staff or healthcare workers are critical for establishing and

maintaining effective communication, disseminating information or instructions, and

resolving problems related to all parts of laboratory services. Every month, a meeting

will be held to discuss each employee's performance and any work-related issues. All

of the employees present will convene an emergency meeting right away if an

emergency circumstance arises in the laboratory

2.1.11. Identification of Work Pay

The Providence Medical Laboratory requires all staff to have a valid driver's

license. Identification paper to prove his or her presence in the laboratory in order to

be paid for work. On the first eight (8) hours of work performed on a regular holiday,

the PML employee will be paid 100% of his or her regular salary for that day. The

employee will be paid an additional 30% of his or her hourly rate for work completed

in excess of eight hours (overtime work). Employees will be paid an additional 30% of

their daily rate of 200 percent for labor done on a regular holiday that also occurs on

their rest day. An additional 30% of the employee's hourly rate will be paid for work

done in excess of eight (8) hours (overtime work) during a normal holiday that also

falls on the employee's rest day.

42 | P a g e
2.2. Management of Physical Facilities

PML management is responsible for providing proper physical amenities for the

services provided, and the Department must have adequate space to guarantee that

work is completed safely and efficiently. Patients, healthcare professionals, and

visitors must be safe, dangerous substances, when necessary, there will be an

overnight accommodation that is easily accessible and secure.

PML is responsible for monitoring, controlling, and recording environmental

conditions where they are required by applicable specifications or may have an impact

on the quality of the results.

2.3. Equipment and Instruments

The Providence Medical Laboratory shall be required to have full and sufficient

equipment and materials for the performance of laboratory services, which include

sample collection, sample preparation, sample processing, sample storage, and

laboratory evaluation.

2.4 Reagent, Control, Standards, Glassware and Supplies

The PROVIDENCE MEDICAL LABORATORY assured that;

a) The standards we used in the lab on several platforms are highly maneuverable

and adhere to DOH safety and standard procedure.

b) As a laboratory control compliance, the quality controls that our laboratory may

provide are controlled and well defined.

c) The glassware we use is of high quality and meets industry standards.

43 | P a g e
 d) The providers we dealt with were prompt in responding to our needs and

demands in the laboratory, ensuring that our laboratory met the highest quality

standards.

REAGENTS

In the clinical laboratory, using analytical grade chemicals is both recommended

and required. However, because the majority of the chemicals are highly dangerous,

reagents should always be handled with extreme caution. Each and every container

of chemicals (and gases) that arrives in the laboratory must be labeled.

Each reagent's label should provide the following information:

a) Reagent’s name

b) Expiry date

c) Date received

d) Name of the person who received the reagent

e) Date opened

f) Name of the person who opened the reagent

g) Remarks

h) Storage location

When taking reagents from the bottle, there are three (3) rules that must be

followed by all healthcare personnel:

a) Always use a clean spoon or spatula; if it's simply hanging around, don't use it

around.

44 | P a g e
 b) Do not return the chemical to its original container.

c) After each usage, firmly close the bottle.

CONTROL

To ensure that the proper amount of supply is constantly available, the clinical

laboratory must have an inventory control system for the equipment. Providence

Medical Laboratory must have appropriate internal and production controls in place to

ensure that it can meet and surpass the demands of all patients.

The inventory should include the expiration dates of all laboratory chemical

reagents, control materials, the day and time the material was put into service,

warranty information, and so on.

The clinical laboratory must ensure that there is always an adequate supply of

reagents, glassware, standards, control, and other supplies required for the

laboratory's operation to run smoothly. Before being employed, new standards are

constantly examined and validated; standards that have not expired are used.

Volumetric glassware and measuring instruments are employed in the industry.

The calibration of measurements and calculations related to the tests is performed.

Every healthcare worker is aware of the proper storage, handling, cleaning, and

disposal procedures for laboratory glassware.

2.5 MANAGEMENT OF SUPPLIERS

Providence Medical Laboratory has sufficient reagents, kits, machines, and

supplies to complete the services provided.

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Manufacturer Selection:

When selecting a worthy candidate, Providence Medical Laboratory will

evaluate the following manufacturers/suppliers.

a) Reliable, high-quality supplies

b) It was delivered on schedule.

c) The Department of Health (DOH) and other certifying agencies have given their

approval.

Upon receipt of materials, procedures for inspection, acceptance/rejection, and

storage are being adopted. All materials arriving at the facility must pass an initial

quality check by the Providence Medical Laboratory staff before being used.

a) The Providence Medical Laboratory has made the excellent decision to select

the best and most appropriate manufacturer for our laboratory supplies.

b) We work with high-quality local and international manufacturers, high-quality

goods and a high level in terms of various supplies.

c) Our manufacturer's quality assurance has been properly tested and passed the

quality assurance test.

46 | P a g e
Suppliers and Manufacturer List:

PROVIDENCE MEDICAL LABORATORY

LOCAL

a) K&N MEDICAL TRADING

b) THE LAB SUPPLIES INC.

c) THE ANALYST SUPPLIES TRADING

d) BELMAN LABORATORY SUPPLIES TRADING

INTERNATIONAL PARTNER

a) DEVAXIA MEDICAL HOUSE

b) BRIDGE MORIS SUPPLIES

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GROUP OF STANDARDS NO. 3
SERVICE DELIVERY

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3.1 Customer Needs and Requirements

Providence Medical Laboratory services must be ready to meet the needs and

requirements of patients, doctors, and other service applicants. The documents or

actions taken to meet the needs are listed below.

customer requirements:

a) Special cases of patients, (if any)

b) Turn-Around Time (TAT)

c) Conditions of transport

At least once a year, the documents are revised and modified (annually).

3.2 Contact

Agreement with the Philippine Solid Waste Management Association (SWAPP)

for waste disposal must be established and documented in a contract Memorandum

of Agreement or another appropriate document. The Memorandum of Agreement

(MOA) is a legal document that describes the terms and details of the partnership

agreement between the Providence Medical Laboratory (PML) and the Solid Waste

Management Association of the Philippines (SWAPP).

The following items must be included in the Memorandum of Agreement:

a) Purpose of the Agreement;

b) Detailed Descriptions of Responsibilities;

c) Payment Schedule;

d) Duration of the Agreement; and

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 e) Signatures from both parties.

The Memorandum of Agreement (MOA) details how the Providence Medical

Laboratory and the Solid Waste Management Association of the Philippines

(SWAPP) will collaborate to reduce environmental hazards and waste within the

clinical laboratory.

The Providence Medical Laboratory will manage $20,000 seed grant 3,000 pesos

to the Philippine Solid Waste Management Association (SWAPP). The seed grant

will be split into two payments. The first installment of 1,500 pesos will be paid upon

receipt of the Memorandum of Agreement. The second installment of 1,500 pesos

will be paid pending receipt and approval of the interim progress report, which is due

on Date.

The Memorandum of Agreement (MOA) will be in effect from January 1st to

December 31st and may be updated at any time by written agreement of each

partner. With 30 days written notice, either party may terminate the agreement.

3.3 Administrative Procedures

Procedures governing the administrative aspects of clinical operations the laboratory

must be documented. A Manual of Administrative Procedures is used to guide

laboratory personnel. composed of the following elements:

a) Standard Operating Procedures (SOP) for each clinical section laboratory.

b) Organizational Structure, as well as Management and Staff Duties and

Responsibilities.

50 | P a g e
 a) Procedures for adding, installing, obtaining, calibrating, and validating

equipment before it is used for patient care.

b) Preventative maintenance and equipment repair procedures.

c) Procedures for inventory control of glassware, reagents, and chemicals

laboratory equipment.

d) Procedure for receiving samples and patient requests.

e) Laboratory examination analysis and reporting procedure.

f) Critical Values Laboratory Physicians' Immediate Response Process.

The Administrative Procedures Manual must be reviewed annually (every year).

3.4 Technical Procedures

A method for each test is chosen to ensure the consistency, reliability, and

clinical relevance of the examination in the Providence Medical Laboratory. The

chosen laboratory procedures are documented in a Manual of Technical Procedures,

which is available at each section.

The Manual Technical Procedure is reviewed and updated on an annual basis

(every year).

ADMINISTRATIVE POLICIES & PROCEDURES

CLINICAL CHEMISTRY SECTION

The clinical chemistry section determines the concentration of various

substances. Analytes in the body include glucose, lipids, non-protein nitrogen (blood

51 | P a g e
urea nitrogen, blood uric acid, and creatinine), electrolytes, and enzymes, for

example (alanine transaminase and aspartate transaminase).

PROCESSING

Patient Preparation

Prior to blood collection, the patient will be instructed on how to get ready for

each laboratory test. To minimize factors that may influence laboratory results,

extreme caution will be exercised.

For patient preparation, examination is divided into two categories.

Prior to specimen collection for examinations: Fasting and Random. Blood is

typically collected from a patient who is in the post-absorptive state. Except for

electrolytes, enzymes, glycated hemoglobin, and serum Creatinine, this is usually

accomplished with an overnight fast (6-8 hours) in a three (3) cc redtop tube, with the

exception of glycated hemoglobin, which is placed in an EDTA tube. All lipid

determinations (Triglyceride, HDL, LDL, and VLDL) require twelve (12) to fourteen

(14) hours fasting prior to specimen extraction, with three (3) to five (5) cc of blood in

a red top tube.

Patients will be instructed to refrain from smoking prior to specimen collection.

Prevent physiologic increases in certain analytes that may have an impact on

laboratory results.

52 | P a g e
Medications are also recorded in order to alert personnel to the possibility of the drug

to influence the outcome. The analytes' diurnal variations are also observed to

ensure the accuracy of the results.

Specimen Collection and Handling

These include proper specimen collection techniques and its documentation.

Transportation to the laboratory and identification Blood should be collected using a

thoroughly clean tube that is free of contaminating agents. It must bear the proper

label, which includes the patient's name and the date of collection.

Specimen Processing, Storage and Transport

All measurements should be taken 45 minutes to an hour after collection.

Separation of serum or plasma from cells should occur as soon as possible (preferably

within one hour).

All specimens will be centrifuged for 10 minutes at 3000 RCF (relative

centrifugal force) which is the standard centrifugation time. If the analysis is to be

delayed, serum or plasma must be stored at 4°C to 6°C for more than 4 hours.

Photosensitive analytes must be wrapped in carbon paper to protect them from

light exposure.

Specimen Rejection

The following are reasons for specimen rejection for laboratory

testing/examinations:

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 Hemolyzed, icteric, and lipemic samples will not be examined because of a

significant effect in the laboratory results.

Mislabeled specimens, an incorrect blood-to-anticoagulant ratio, and

insufficient rejection is based on specimens, improper fasting (if necessary), and

incorrect tube/container use.

When to Repeat the Analysis

The results are either extremely high above or extremely low below normal. In

this case, the requesting physician has reservations about the results. The controls

are not operating within the normal allowable range. Final Report and Release of

Results

Check all results twice before typing or relaying the final report to the

requesting a doctor All results should be signed by the person who performed the

test.

Cleanliness and Orderliness

Always ensure that all items and materials are returned to their proper places

and in the proper order. When not in use, all reagents are stored in their designated

locations.

54 | P a g e
Procedures for Examination

A. Glucose Determination

a) Fasting Blood Sugar or Random Blood Sugar

It is an indicator of the overall glucose homeostasis. Blood is obtained from 8 hours

of fasting and placed in a red top of 3cc. The spectrometric analysis is utilized to

determine glucose levels according to the manufacturer’s reagent.

b) Oral Glucose Tolerance Test (OGTT)

This is used to assess how well glucose is metabolized by the body given a

necessary timeframe or period of time. In this type of test, patients are considered as

outpatients and they must eat an unregulated diet of 150 grams of carbohydrates a

day for 3 days prior to testing. Below are the procedures in OGTT

1. Collect blood samples to be used for blood testing.

2. Instruct the patient to take the glucose load within 5 minutes.

3. Obtain blood samples after an hour and after two hours.

c) Oral Glucose Challenge Test (OGCT)

OGCT is used for measuring the body’s response to glucose and is used in

screening gestational diabetes. Below are the procedures in OGCT

1. Obtain the fasting blood sample.

2. Instruct the patient to drink the glucose load within 5 minutes.

3. Collect the patient’s blood sample after an hour.

d) Glycosylated Hemoglobin (HbA1c)

HbA1c is a test used to control long term glucose regulation. It represents the

average amount of glucose in the blood over the previous 2-4 months. Specimens are

collected from the patient’s non-fasting state and placed in an EDTA tube.

55 | P a g e
 e) Lipid Determination Profile (LDL)

LDL is a type of test which calculates the total cholesterol, triglycerides, high

density lipoprotein (HDL), and the ratio of HDL to the total cholesterol.

In this test, the specimen is obtained from 12-14 hours of fasting, and placed in a

5-cc red top tube. Low density lipoprotein is determined by reducing the real value of

HDL and VLDL from the total cholesterol. VLDL is obtained by dividing the real value

of triglycerides by 2.2. Lastly, the ratio of total cholesterol to HDL is obtained by

dividing their values.

f) Non-Protein Nitrogen (NPN)

a) This test determines the urea nitrogen and uric acid in the blood, as well as

creatinine.

b) Blood is obtained from a patient’s non-fasting state with the exception of

uric acid in the blood (6 hours fasting to prevent lipemia)

g) Electrolytes

a) This test involves the determination of sodium, potassium, chloride, and

ionized calcium. Blood is obtained in a 3-cc red top tube while the patient is

in a non-fasting condition.

b) Patients are asked to refrain from exercise, fist clenching during time of

extraction, and proper use of tourniquet must be observed by the staff to

avoid physiological rises in potassium. The specimen is immediately

examined to avoid the dilution of the sample due to the electrolyte change

in the extracellular fluid.

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 h) Enzymes

This test includes the determination of aspartate transaminase or AST and

alanine transaminase or ALT. Blood is collected in a 3-cc red top tube during the

patient’s non-fasting condition. Specimens must be void from contamination of red

blood cells to prevent possible physiological rise in AST.

i) Blood Glucose Test

The glucose test measures the quantity of glucose found in the blood. Also

known as sugar, glucose is known to be the body’s primary source of nutrition. One

body transforms the carbohydrates it consumes into glucose. Glucose monitoring is

mainly conducted to screen for type 1 diabetes, type 2 diabetes, and gestational

diabetes. Diabetes is a disease which leads to the increase of blood glucose. A healthy

person’s glucose levels are regulated by a hormone called insulin in the body. But if a

person has diabetes, his or her body does not produce sufficient insulin or the insulin

does not function properly. This results in the increase of the patient’s blood glucose.

If left untreated, high blood glucose levels may cause organ damage. In fact,

this leads to increased blood glucose levels.

If left untreated, high blood glucose levels can cause organ damage. More

rarely, glucose tests can also be used to screen for hypoglycemia, which happens

when blood glucose levels are too low. And if this is still left untreated high blood

glucose levels can cause organ damage. Sometimes, glucose tests can also be used

to screen for hypoglycemia. Hypoglycemia occurs when blood glucose levels are too

low.

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Side-Notes/ Takeaways:

i. Blood glucose tests determine the amount of sugar called glucose in the

blood sample. Glucose is a significant source of energy for most cells in the

body, along with brain cells. Carbohydrates can be found in fruit, cereal,

bread, pasta, and rice. These are easily converted into glucose in one’s

body. Carbohydrates increase the blood glucose levels of a

person. Meanwhile, the hormone insulin, when released in the body, helps

regulate blood glucose levels.

ii. Blood glucose may be used to detect elevated blood glucose or

hyperglycemia and low blood glucose or hypoglycemia. Screening for

diabetes is visible in people at risk for signs and symptoms. There are some

cases where there are no early signs or symptoms of diabetes. Thus,

screening is greatly beneficial to patients, because it helps to recognize

early onset of disease and enables care before a particular condition

worsens or where complications occur. Screening also helps detect

diabetes, pre-diabetes, and gestational diabetes. Moreover, screening is

important as it assesses the glucose levels in persons diagnosed with

diabetes.

Below are the following procedures for this test:

1. Remove the test strips from the jar and completely insert the strips into

the monitor.

2. Connect the lancing device cap to the lancing device if it is not already

connected. Then, use the depth dial at the top of the lancing system to

pick the penetration width of the lancing tip.

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 3. Position the tip of the lancet on the side of the fingertip to avoid having

a commonly used part of the fingertip.

4. Press the lancet discharge button.

5. Hold the patient’s hand to allow a drop of blood to appear. Note that if

the blood does not come out quickly, gently pinch the end of your finger.

6. Touch the drop of the blood to the test strip. The blood will be absorbed

by the wicking action of the test strip.

7. Record the blood glucose level displayed in the monitor.

Expected Results or Outcomes are as ff:

1. High glucose levels most often suggest diabetes.

2. Many other conditions and disorders can cause high blood glucose

levels.

3. In a person with signs and symptoms of diabetes or hyperglycemia, a

non-fast glucose level, such as random blood sampling when equal to or

greater than 200 mg/dl (11.1mmol/L) indicates diabetes.

Table 3.1

A graph showing the determinants of fasting blood glucose is illustrated below:

Glucose Level Indication

From 70 to 99 mg/dl (3.9 to 5.5 mmol/L) Normal Fasting

Glucose

From 100-125 mg/dL (5.6-6.9 mmol/L) Pre-Diabetes

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 126 mg/dL(7.0mmol/L) and above on more than one testing Diabetes

occasion

Table 3.2

A graph showing the determinants of a two-hour oral glucose tolerance test or OGTT

is illustrated below:

Glucose Level Indication

Less than 140mg/dL(7.8mmol/L) Normal Fasting

Glucose

From 140 to 199 mg/dL(7.8 to 11.1 mmol/L) Pre-Diabetes

Equal or greater than 200 mg/dL(11.1 mmol/L) on more than Diabetes

one testing occasion

j) Blood Urea Nitrogen (BUN) Test

a) A common blood test that reveals valuable details about how well the

kidneys and liver function

b) It tests the amount of urea nitrogen in the blood of the patient.

c) Here is how the body normally shapes and gets rid of urea nitrogen: The

liver creates ammonia that contains nitrogen after breaking proteins used

by the cells of the body. Nitrogen interacts with other elements, such as C,

H, and O, to form urea, which is a chemical waste product. Then, the urea

60 | P a g e
 flows through the bloodstream from the liver to the kidneys. Healthy kidneys

filter urea and eliminate other waste products from your blood. The filtered

waste products leave one’s body in the form of urine. The Blood Urea

Nitrogen or BUN test can reveal if urea nitrogen levels are higher than

normal. This indicates that your kidneys or liver are not functioning properly.

Below are the procedures needed to prepare the mono reagent for this test:

1. Label all the test tubes standard and samples respectively.

2. Pipette R2 1ml or 1000µl on all test tubes.

3. Pipette 0.1 or 10 µl of sample, standard on respective test tubes.

4. Mix and incubate for 5 minutes.

5. Pipette R2 200µl of all the tubes.

6. Mix and read the change of absorption (ΔA) between 30 seconds and 90

seconds

Calculations for this test are as ff:

a) Urea = ΔA sample / ΔA standard X Urea standard

b) Results (Normal Values

c) Adults - 10–20 milligrams per deciliter (mg/dL) or 3.6–7.1millimoles per liter

(mmol/L)

d) Children - 5–18 mg/d

k) Blood Uric Acid Principle

a) This test utilizes Vitros slides, which are dry, multilayer analytical

components covered with polyester supports. A small volume of patient

sample is collected on the slide and uniformly distributed over all layers. The

61 | P a g e
 spread layer contains the required substrate and other components needed

for the reaction.

b) The sample analyte catalyzes the reaction sequence to produce products

that absorb light at wavelengths in different regions (e.g.: 340-680 nm),

spreads to the underlying layer and is traced by reflectance

spectrophotometry. The test types are colorimetric, enzymatic, two-point or

multi-point, or potentiometric.

c) The rate of change in the reflecting density once converted into enzyme

activity or the amount of colored complex produced is proportional to the

concentration of the analyte in the sample.

i. Specimen:

2 ml serum collected in a red top tube with a serum separator (gel barrier)

Method:

Dry Slide Chemistry

Procedures

1. Label all test tubes blank, standard and sample respectively.

2. Pipette R1 1ml (1000µl) on all the test tubes.

3. Pipette 0.2 (20µl) of sample, standard on the respective test tube.

4. Mix and incubate for 5 minutes.

5. Mix and read the change of absorption (A) between 60 seconds against

reagent black at 505 nm (490-550) nm.

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Calculations:

• Uric Acid= ΔA sample / ΔA standard X Urea standard

Results (Normal Values)

a) Male - 3.5-8.5 μg/dl

b) Female 17 -34 years of age → 2.5-6.2 μg/dl 35

c) 44 years of age → 2.5-7.0 μg/dl

d) 44 years of age → 2.5-7.5 μg/dl

l) Creatinine Test

Creatinine is produced as a waste product of creatinine and phosphocreatine.

Since most of the creatinine is produced in muscles, the amount of creatinine that is

measured in blood is proportional to the patient’s lean muscle mass. The waste

product creatinine enters the blood supply and is released in the urine. The

measurement of creatinine is used to aid in determining renal function. The principle

of the measurement of creatinine depends on the Jaffe reaction. It states that under

alkaline conditions, creatinine reacts directly with picric ions and creates a reddish

complex, the absorbance of which can be measured at 520 nm. Yet, several interfering

substances, such as proteins, ketones, glucose, and ascorbic acid, also react with

picric acid, producing similar-colored complexes. Serum proteins are precipitated with

tungstic acid solution before measuring creatinine.

i. Specimen

a) Frozen serum can be used if gently thawed and thoroughly mixed prior to

use.

63 | P a g e
 b) A random urine specimen or urine from a 24-hour collection preserved with

15 g of boric acid may also be used.

ii. Supplies/ Equipment:

a) Spectrophotometer

b) Spectrophotometer cuvettes

c) 5 mL test tubes

d) Pipettes

e) Paraffin squares

f) Timer

g) Distilled deionized water

h) Picric acid, 0.036 mol/L. (Dissolve 9.16 g reagent grade picric acid with warm

water, cool, then make up for 1L volume.

Tungsten Acid in Polyvinyl alcohol

Steps:

1. Place 1g of polyvinyl alcohol in 100mL of water and heat to dissolve but do not

boil).

2. Transfer to a 1 L volumetric flask containing 11.1 g Na2WO4 · 2H20 in 300 mL

of water.

3. Add 2.1 mL concentrated bH2SO4 in 300ml/ water.

4. Mix and dilute with water to a 1L volume. (This solution is stable at room

temperature (25°C) for two years and does not need refrigeration.

5. NaOH, 1.4 mol/L. Dissolve 54 g NaOH in water and dilute to 1 L volume. Store

in a polyethylene bottle.

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 6. Creatinine standards, 0.5 mg/dL, 1.0 mg/dL, 2.0 mg/dL, 4.0 mg/dL, 10.0 ***

mg/dL.

Procedures:

1. Don’t turn off the spectrophotometer, and let it warm up for 15 minutes.

2. Set the wavelength to 520 nm.

3. Dilute urine specimens 1:10 using distilled deionized water.

4. Precipitate the proteins present in the patient serum, or urine specimens and in

each, control by adding 0.5 mL of the specimen to 4.0 mL tungstic acid in a test

tube. Then, shake vigorously and centrifuge for 10 minutes.

5. Label cuvettes 1 through 10.

6. Add 1.0 mL of picric acid solution to cuvettes 1 through 10.

7. Add 3.0 mL distilled deionized water to cuvette 1.

8. Add 3.0 mL of the 0.5mg/dL creatinine standard to cuvette 2.

9. Add 3.0 mL of the 1.0 mg/dL creatinine standard to cuvette 3.

10. Add 3.0 mL of the 2.0 mg/dL creatinine standard to cuvette 4.

11. Add 3.0 mL of the 4.0 mg/dL creatinine standard to cuvette 5.

12. Add 3.0 mL of the 10.0 mg/dL creatinine standard to cuvette 6.

13. Add 3.0 mL of the protein free centrifugate of control Level One to cuvette 7.

14. Add 3.0 mL of the protein free centrifugate of control Level Two to cuvette 8.

15. Add 3.0 mL of the patient's protein free serum or urine centrifugate to the

remaining cuvettes.

16. Mix by inversion using a paraffin square to prevent spillage.

17. Add 0.5 mL of the NaOH solution to the first cuvette. Mix and set a timer for 15

minutes.

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 18. Add 0.5 mL of the NaOH to the remaining cuvettes at 30 second intervals.

19. After 15 minutes, place cuvette 1 in the spectrophotometer and set the

absorbance to read 0.000.

20. Read Absorbance at exactly 15 minutes after adding the NaOH and record the

absorbance for cuvettes 2-10.

Results in Normal Values:

a) Adult Female → 0.6-1.2 mg/Dl

b) Adult Male → 0.8-1.5 mg/dL

m) Cholesterol Test

a) A complete cholesterol test is called a lipid panel or lipid profile. It is a blood

test that can determine the amount of cholesterol and triglycerides

throughout the blood.

b) The cholesterol test will aid to assess the likelihood of plate build-up in the

arteries that can lead to narrowed or blocked arteries in the body

(atherosclerosis).

c) High cholesterol levels generally do not cause any signs or symptoms, so

the cholesterol test is an essential factor.

d) High cholesterol levels indicate a major risk factor for heart disease. The

complete cholesterol test, referred to as the lipid panel or lipid profile,

involves the measurement of 4 forms of fats or lipids in the blood of the

patient.

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Terminologies:

i. Total cholesterol

Refers to the sum of one’s blood’s cholesterol content

ii. High Density Lipoprotein (HDL) Cholesterol

a) Refers to the “good cholesterol”, because it helps carry away LDL cholesterol

b) Allows arteries to open and patient’s blood flowing more freely

iii. Low-Density Lipoprotein (LDL) Cholesterol

a) Refers to the “bad cholesterol”

b) States that too much LDL in the patient’s blood leads to the formation of fatty

deposits or plaques in one’s arteries, also called atherosclerosis.

Atherosclerosis reduces blood flow. Hence, these plaques sometimes rupture

and can lead to a heart attack or stroke.

iv. Triglycerides

a) A type of fat in the blood

b) When a patient seats, his or her body converts any calories the body does not

need into triglycerides, which are stored in fat cells.

c) High triglyceride levels are associated with several factors including being

overweight, eating too many sweets or drinking too much alcohol, smoking,

being sedentary, or having diabetes with elevated blood sugar levels.

Sample Needed

1. Blood

Procedures are as ff:

1. A blood test is obtained to test for the cholesterol levels. Usually, if a patient is

only testing for HDL and total cholesterol, he or she may eat beforehand.

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 However, if he or she is currently having a complete lipid profile done, he or she

should not eat or drink anything aside from water for 9-12 hours before the test.

2. If a patient is undergoing medications that may increase his cholesterol levels

such as birth control pills, the doctor may ask the patient to stop taking these

medicines a few days before the test. The test is usually done in the morning,

because this is the time when patients have already fasted since the night

before. A blood test is an out-patient procedure, usually performed at a

diagnostic laboratory. The procedure takes only a few minutes and is relatively

painless.

Procedures in Collecting Blood:

1. Wrap an elastic band around the patient’s upper arm to stop the flow of blood.

This allows the veins below the band to become larger, so it becomes easier to

insert a needle into the vein.

2. Cleanse the needle site using alcohol.

3. Insert the needle into the vein. More than one needle stick may be needed.

4. Attach the tube to the needle to fill it with blood.

5. Remove the band from the patient’s arm when sufficient blood is extracted.

6. Place a gauze pad or cotton ball over the needle site while the needle is being

removed.

7. Put pressure on the site and then put on a bandage.

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 Table 3.3

Results for this test are illustrated below:

Total Cholesterol

Less than 200 mg/dL→ Desirable

200-239 mg/dL → Borderline High Risk

240 and above → High Risk

High Density Lipoprotein (HDL)

Less than 40 mg/dL (males); less than 50 mg/dL(females) → increased risk of heart

disease

Greater than 60mg/dL: Some protection against heart disease

Low Density Lipoprotein (LDL)

Less than 100 mg/dL: optimal

100-129 mg/dL: near optimal/ above optimal

130-159 mg/dL: borderline high

160-189 mg/dL: high

190 mg/dL and above: very high

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 Triglycerides

Less than 50 mg/dL: normal

150-199 mg/dL: borderline to high

200-499 mg/dL: high

Above 500 mg/dL: Very High

HEMATOLOGY SECTION:

The hematology section of PROVIDENCE MEDICAL LABORATORY offers

testing for complete blood count (CBC) with differentials, blood glucose testing,

urinalysis, body fluid analysis, and routine hematology testing.

Processing Details:

Handling and Receiving of Specimen and Request

a) Specimen that are collected are examined efficiently

b) Specimens that are duplicated, unlabeled, mislabeled, low in quantity,

excessive in quantity, hemolyzed, clotted, and contaminated are rejected.

However, if the specimens have proper volume and label, then the specimens

are recognized as qualified or fitted for the analysis.

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Procedures for Examination:

A. Hematocrit Determination or Microhematocrit

Procedures are as ff:

1. Venous blood that is collected in EDTA and capillary tubes with blue tips must

be used.

2. Capillary that has been collected from a finger prick must be placed in

heparinized tubes or the red tip.

3. Gently mix the tube by inverting it 8-10 times.

4. Collect the blood and fill the tube about one-half and two-thirds.

5. Wipe off the outside of the tube.

6. Seal the end of the tube with a small amount of clay. Avoid excessive clay than

necessary for firm seal.

7. Place the tube in the hematocrit centrifuge.

8. Set each hematocrit before putting on the lid.

9. Close the lid and spin for 3-5 minutes.

10. After the centrifuge shuts off, the hematocrit must be read promptly.

11. Do not read the hematocrit in which the red pack has already begun to slant.

12. Micro hematocrit must be read at the top of the red cell layer and not at the top

of the buffy coat.

13. Results must be reported in packed cell volume.

14. Standardized hematocrit centrifuge.

a) Pick 3 specimens that are in 7-9, 10-12, and 14-16g/dL.

b) Then, prepare 3 capillary tubes to be used for each hemoglobin level, 9 capillary

tubes, and spin one for each level at 3 minutes.

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 Table 3.4

The hematocrit levels:

Time 7-9 g/dL 10-12g/dL 14-16g/dL

3 Minutes 21.0-30.0 30-36 41-48

4 Minutes 20.0-29.0 29-35 41-47

5 Minutes 20.0-29.0 29-35 41-47

When there are no changes for all the hemoglobin levels that is chosen, is the time

in which hematocrit readings are stabilized.

B. HEMOGLOBIN DETERMINATION / CYANMETHEMOGLOBIN

Procedures:

1. Put 5ml of Drabkin's reagent into a test tube.

2. Then get 0.02ml of whole blood with the use of Sahil pipet.

3. Place the 0.02ml of blood in Drabkin’s reagent by rinsing.

4. Mix and let it stand for 10 minutes.

5. Read in the spectrophotometer at 540 nm.

6. Dispose the reagent properly.

C. BLOOD INDICES

Red blood cells or RBC indices are part of the complete blood count or CBC

and are comprised by four different components that make up the mean corpuscular

hemoglobin concentration (MCHC), mean corpuscular volume(mcv), mean

corpuscular hemoglobin (MCH), and red cell distribution width (RDW), and correlated

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the indices with hematocrit, hemoglobin, and red blood cell count that ascertain the

technical problems that is being identified when they occur.

C.1: Mean Corpuscular Hemoglobin Concentration (MCHC)

Refers to the measure of the average concentration of hemoglobin itself in a

single red blood cell in percentage form (%) Hgb concentration of average red cell. It

also classifies red blood cells in normochromic (normal) and hypochromic (low).

a) Mean Corpuscular Hemoglobin Concentration (MCHC)

The measure of the average concentration of hemoglobin itself in single red

blood cell in percent (%) Hgb concentration of average red cell. Also, it classifies red

blood cell in normochromic (normal) and hypochromic (low)

Formula for MCHC is as ff:

MCHC (g/dL) = (Hgb ÷PCV) x 100 or

MCHC (g/dL) = (Hgb ÷HCT) x 100

Where:

MCHC= mean corpuscular hemoglobin concentration

Hgb= Hemoglobin

HCT= Hematocrit

Normal Value: 29+/-2%

C. 2: Mean Corpuscular Volume (MCV)

The average volume of red blood cells in a specimen. I also has the utility in

helping to determine the etiology of anemia. It classifies a red blood cell as normocytic

(normal), microcytic (small), and microcytic for large.

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Where:

MCV = (Hct x 10) ÷ RBC

MCV= mean corpuscular volume

Hct= Hematocrit

RBC= Red blood cell

Normal Value: 29+/-2 uug

Procedures for obtaining MCV are as ff:

1. 0.5 WBC pipette must be drawn into an anti-coagulated blood or capillary blood.

2. Draw WBC diluting fluid / weak acid solution up to mark 11.

3. Allow blood-diluent mixture to sit together for 5 minutes, to lyse rbc.

4. Mix the blood-diluent mixture.

5. The first 2-3 drops must be discarded.

6. Charge counting chamber.

7. Examine with a low power objective (lpo).

Computation is as ff:

No. of WBCs in Procedures:

3 squares multiply by 50 = No. of cells divided by cu mm (Conventional

units)

D. RED BLOOD CELL (RBC) COUNT

Principle:

Blood specimen is being diluted with the use of isotonic fluid or in a fluid that is

great enough to prevent the hemolysis of RBCs. When the blood is diluted, it will be

placed in a hemocytometer, and the cell must be counted under a microscope.

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 E. Diluting Fluid: Hayem's Solution or Isotonic fluid

All the non-nucleated cells must be counted in 5 squares of the counting

chamber under high power objective (hpo).

Procedures:

1. Draw the blood directly into the RBC pipette up to the 0.05 mark.

2. Wipe the tip of the pipette so that the extra blood will be removed.

3. Draw up the diluting fluid up to the 101 mark.

4. Rotate pipette gently for about 2-3 minutes to mix the diluting fluid.

5. The first 3-4 drops of solution must be discarded. Do not over spill.

6. Allow cells to settle in counting chamber for 2 minutes before you count.

7. All the non-nucleated cells must be counted in 5 squares of the counting

chamber under high power objective (hpo).

8. All the non-nucleated cells must be counted in 5 squares of the counting

chamber under high power objective (hpo).

F. Platelet Count

Principle:

Well mixed anticoagulated blood is added to a diluent at specific volumes in an

unopette reservoir. The diluent or 1% ammonium oxalate would lyse rbc, but it would

preserve WBC’s and platelets. 20µL pipette must be used with the 1.98 ml of 1%

ammonium oxalate to make 1:100 dilution. Diluted blood will be added in a

hemocytometer chamber. Then, let the cell to settle for 10 minutes before wbc and

platelets are counted.

Procedures:

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 1. Using diluting fluid, rinse pipette to prevent platelets adhering inside the pipette.

2. Draw the blood up to 1 mark and 101 diluting fluid.

3. Mix well for 2 minutes

4. Fill both sides of counting chamber

5. Let platelets settle for 10 minutes.

G. LEUKOCYTES TYPE NUMBER FRACTION (DIFFERENTIAL COUNT)

Principle:

Skin puncture and time required for reading to stop must be recorded, it

determines the role of platelets and capillaries integrity. The number of different types

may deviate from normal acceptable range. Percentage deviation from normal may

indicate certain diseases.

Making of Smears

1. On a clean slide, put a small drop of blood from middle to one end.

2. Above the first slide, hold a second slide with angle of 45 degrees

3. To the middle of first slide, touch the second slide that makes drop of blood

within 98 degrees acute angle.

4. The second slide must be drawn toward the drop of blood to the end of slide for

the blood to spread along in an acute angle.

5. The upper slide must be moved rapidly on the other direction.

6. It must be stained with "rapi stain"

7. Let it dry before examining under oil immersion.

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Differential Leukocytes: Percent cells multiplied by 0.01 = number fraction

Procedures:

1. Clean two slides for spreader and cover.

2. Do a finger prick using a lancer and obtain a drop of blood.

3. Start the stop-watch.

4. Blot every drop of blood coming out every 30 seconds using blotting paper, but

do not or prevent the paper from touching bleeding spot.

5. Stop the timer as soon as bleeding ceases.

6. Count the number of drops on the filter paper then multiply by 30 seconds.

Normal Value:

Varies from 1 to 5 minutes by using Duke Method.

Clinical Significance:

This test helps to evaluate platelet function that involves the creation of

standardized incision and timing. Bleeding Time (BT) that is being prolonged can be

found in the thrombocytopenia, thrombasthenia, and also Von Willebrand Disease that

occurs whenever your platelet count is already less than 50,000/µL of blood.

CLINICAL MICROSCOPY SECTION:

Our clinical microscopy section performs routine and special tests on patients’

non-blood body fluids, such as urine and stool. These samples are chemically

analyzed and examined at the microscopic level. The macroscopic, chemical, and

microscopic examinations of urine provide initial valuable diagnostic information

concerning metabolic dysfunctions of both renal and non-renal origin. Urinalysis is

77 | P a g e
important to detect diseases such as urinary tract infections, kidney disease, liver

problems, diabetes, or other metabolic conditions. Analysis of stool samples such as

occult blood determination and stool examination for fats help clinicians in early

detection of gastro-intestinal bleeding, liver and biliary duct disorders and

malabsorption syndrome. The identification of parasites and the extent of parasitism

assessment are also performed in this section.

SPECIMEN REJECTION:

Tests cannot be performed in the laboratory if samples fall short of the quality

volume or other eligibility criteria. In these cases, PROVIDENCE MEDICAL

LABORATORY may need to reject the samples, and not carry out the processing.

Although turnaround times may be affected, it avoids having to arrange for samples to

be taken again.

The following are the criteria of specimen rejection:

1. Specimen in incorrect containers

2. Insufficient specimen received

3. Labeling or form issues (mislabeled/unlabeled/no forms/no clinical information)

4. Specimen is broken or has leaked in transit. Stability time has been exceeded.

Stability time is test-dependent, and also refers to tests that can only be carried

out on certain days of the week.

5. If the specimen has been contaminated

6. Specimens that are received in expired tubes

7. Specimens deemed to be PRECIOUS (e.g., CSF, fluid, tissue, bone marrow

and pediatric samples) will not be discarded by the laboratory. Results will

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 include a comment relating to the condition of the specimen (e.g., specimen

unlabeled).

PROCEDURES FOR EXAMINATIONS

F.1. URINALYSIS

Principle:

A urine drug testing can help the physician to locate or detect potential

substance abuse problems or health problems. If drugs were detected on your sample,

your doctor may help you by giving you recommendation or treatment and medication.

Taking urine drug tests helps you improve your health in view of the fact that your

physician will recommend a treatment plan that you must follow to see the results that

you are becoming healthy again.

Specimen Collection/ Handling

To avoid transmission of an infectious disease, all specimens, products/ objects

that have been touched/ came in contact with a human or animal body fluid, must be

disposed and handled before and after cleaning/ receiving the product.

Process and Procedures:

1. You will receive a specimen cup from the person administering the test.

2. You’ll need to leave your purse, briefcase, or other belongings in another room

while you take the test. You’ll also need to empty your pockets.

3. In rare cases, a same-gendered nurse or technician will accompany you into

the bathroom to make sure you follow all testing procedures. They should

explain the reason for this type of supervised testing.

4. Clean your genital area with a moist cloth that the technician will provide.

5. Urinate into the cup. You need to produce at least 45 milliliters for the sample.

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 6. When you finish urinating, put a lid on the cup and bring it to the technician.

7. The temperature of your sample will be measured to ensure that it’s in the

expected range.

8. Both you and the collector must keep visual contact with the urine specimen at

all times until it’s been sealed and packaged for testing.

All information must be indicated on the specimen label sample which is located

directly on the container using proper tool for markings and labels that have been

placed on the top/ covers of containers are forfeited/ rejected.

Manner of Reporting

The results for this test are expressed in Nano grams per milliliters (ng/Ml). This

test uses cut off points that they will use as basis for the results, any result below the

cut off is negative and any result above the cut off is positive.

2 types for collecting urine samples for testing and result:

1st Morning Specimen

Collected immediately first thing in the morning after a good night's sleep.

Clinical laboratories preferred this kind of collection for urinalysis in view of the fact

that it is the most concentrated and most likely to reveal the existence of the

abnormalities.

Random Urine Specimen

This kind of collection is known as satisfactory for most urinalysis routines and

known as the least valid kind of specimen for the reason that the results may rely on

what the patient has been digesting or consuming for the past time.

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Clinical Significance:

It is a painless test used for diagnosing diseases or analyzing the presence of

certain illegal drugs and prescription medications using your urine sample. Urine drug

testing usually screens for amphetamines (highly addictive drugs that stimulate the

central nervous system; people with ADHD take them as medications),

methamphetamines, benzodiazepines, barbiturates, marijuana, cocaine, opiates,

PCP, methadone, nicotine, and alcohol.

Gross Examination

The urine physical examination includes its determination in terms of colors,

clarity and specific gravity. This provides the exploration of the information or discovery

that concerns disorders for instance, blood existence in the urine, if there are diseases

spread through the liver, inborn errors of metabolism, and so it may lead to a Urinary

Tract Infection (UTI). The following are the portions that may clarify the results and

findings based on the chemical and microscopic areas of urinalysis:

A. Color

Normal Color:

a) Straw to Light Amber

b) Pale for Diluted Urine

c) Darker for Concentrated Urine

Other Colors:

Bloody red, straw, light/ dark yellow, yellow, tea coloration, amber.

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For blood, drugs, or any dye, diagnostic existence may affect the specimen; for

example: (Refer to the table below)

Table 3.5

A. Urine Color:

Red or Red Brown Smokey appearance; caused by the existence of blood

Yellow or Brown When shaken, the colors turned from green to yellow foam;

bile presence

Olive Green to Brown Caused by phenols; known as a toxic component in the

Black human body

Milky White Caused by chyle; milky fluids that are made up of lymph

and fat droplets

Dark Orange Caused by Pyridium; medicine used for treating urinary

tract infections

Blue Green Caused by methylene blue

i. Clarity

a) Defined as the general term that make reference about transparency/ turbidity

of a specific urine specimen

b) The mixed specimen is identified through visual examination placed in front of

the light source

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The following are the common terminologies used for determining/providing

results/ reports:

Table 3.6

B. Urine Clarity

Clear Transparent in color; particulates are not visible

Hazy Few particulates; print has been seen easily by urine

Cloudy Many particulates easily turned blurred

Turbid Prints are not visible through urine

Milky Clotted/ Many precipitates

C. Specific Gravity

1. The specimen’s specific gravity is the mass of the specimen as compared to

distilled water’s equal volume.

2. It varies directly with the dissolved amount of solids in the urine that normally

ranges from 1.015 – 1.030 during a 24 hour period.

3. With regards to the morning collection of the specimen, it will have higher

specific gravity in view of the fact that it is more concentrated than a specimen

that has passed within the days.

4. High fluid intakes may reduce the specific gravity into 1.010 and below.

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Clinical Examination:

The evaluated chemical characteristics during urinalysis routine include protein,

glucose, pH, ketones, bilirubin, urobilinogen, leukocytes, nitrite, and the specific

gravity. The color chart indicates that the numerical pH values must be reported. The

strip will be dipped simply into the urine sample/ specimen and the color values will be

compared for the various tests on the accompanying chart. Below are the techniques

that were used for reading reagent strip:

a) Dipping the reagent strip on the uncentrifuged yet well mixed urine specimen

at room temperature.

b) Eliminate excess urine on the edge of the strip into the container when strips

are withdrawn.

c) Smear the edge of the strip on a disposable absorbent pad; wait for the reaction

to occur in a particular amount of time.

d) Then lastly, compare the color reaction of the strip result to the color chart in a

good spot of lighting.

D. Microscopic Examination (Sedimentation of Urine)

Preparatory:

1. Stir the specimen wisely.

2. Pour 15mL of urine into a test tube, centrifuge the specimen for 5 minutes at

1500 rpm.

3. Inverting the centrifuge tube may help all the excess of urine to drain out.

4. Tapping the bottom of the tube allows you to re-suspend the specimen.

5. Mount one drop of the suspension on a slide and use a coverslip to cover it.

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 6. Place the slide under the microscope, and scan it using a low power objective

with subdued lighting.

7. For detailed examination, switch to the high-power objective with a minimum of

10 to 15 fields.

Table 3.7

Reporting of Results:

Color and Transparency

Specific Gravity Reported from 1.010 – 1.030

pH Reported from 5.0 – 9.0

Glucose Reported as Negative; trace; +; ++; +++; ++++

Protein Reported as Negative; trace; +; ++; +++; ++++

Casts Reported as no. / lpf

Clinical Significant Findings:

i. Leukocytes

a) Normally 0 to 2 leukocytes per high power field will be seen on microscopic

examination.

b) More than 3 cells per high power field probably indicate disease somewhere in

the urinary tract.

c) To get the estimated number per high power field, you must estimate the

number of leukocytes that are present per high power field.

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 d) Erythrocytes

e) Red cells are not normally seen in the urine, but all dysmorphic red blood cells

must be reported if the existence has been seen under microscopic

examination.

f) If so found, the estimate or number per high power level field must be reported.

g) The percentage of dysmorphic RBC must be reported by counting the number

of dysmorphic RBCs in urine and dividing it to the total number of RBCs seen.

ii. Casts

a) These urinary sediments are formed by coagulation of albuminous materials in

the kidney tubules.

b) These are cylindrical and vary in diameter.

c) Sides are paralleled and the ends are rounded.

d) If casts were found in the urine, it shall be reported immediately in view of the

fact that it may indicate some form of kidney disorder.

e) If the presence of the casts comes larger, then it is positive for albumin.

f) Mostly reported per low power field

Table 3.8

Types of Casts:

a) Frequently most occurring casts in urine

Hyaline b) Colorless, homogenous, transparent, rounded ends

c) Renal hematuria

Red Cell d) Brown to colorless

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 e) Glomerular disease

f) Exists in renal infection and noninfectious inflammation

White g) Hyper segmented Neutrophils

Cell

h) Indicates significant renal disease

Granular i) Fine granules: gray/ pale yellow

j) Coarse granules: darker

k) Often appears black caused by the density of the granules

l) Rarely seen in urine; the renal disease that primarily affects the

Epithelial tubules is infrequent.

m) Parallel rows/ haphazardly

n) Degeneration of granular casts

o) Found in patients with severe chronic renal failure, malignant

Waxy hypertension, & diabetic disease of the kidney

p) Yellow/ gray/ colorless

q) Short/ broad casts/ blunt/ broken ends/ cracked/ serrated edges

r) Results from lupus and toxic renal poisoning

Fatty s) Typical fatty casts: both large and small fat droplets

t) Small fats droplets: yellowish brown

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COOPER REDUCTION TEST (Benedict’s test) Principle:

The chemical determination of urine glucose is done by heating soluble blue

cupric ions of copper sulfate in a strongly alkaline solution. Cupric ions are being

reduced by the urinary reducing agents. For instance, we have glucose to yellow to

brick red insoluble cuprous ions of cuprous oxide.

Procedures

a) Using a test tube, place 5mL of Benedict’s reagent.

b) Add 8 drops of urine, mix it by shaking, then, boil for 2 to 5 minutes using an

alcohol lamp.

c) Wait to cool down, then note the results.

Table 3.9

Interpretation of Results:

Interpretation Reporting Appearance

- Negative - No change in color

+/- Trace No precipitate; green opacity

+ Positive + Green solution w/ yellow precipitate

++ Positive + Green to yellow solution w/ yellow precipitate

+++ Positive + Muddy orange solution w/ yellow precipitate

++++ Positive + Orange to brick red precipitate

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 E. SULFOSALICYLIC ACID PRECIPITATION TEST

Principle

The sulfosalicylic acid test is a cold precipitation test that reacts equally with all

forms of protein. Various concentrations and amounts of SSA can be used to

precipitate protein.

Procedures

1. Add 3mL of 3% SSA agent to 3mL of centrifuged urine.

2. Wait for it to boil while heating, observe for cloudiness.

3. Grading the degree of turbidity

Table 3.10

Interpretation of Results:

Grade Turbidity Protein Range (mg / dL)

Negative - No increase <6

Trace Noticeable 6 – 30

1+ Distinct turbidity with no granulation 30 – 100

2+ Turbidity w/ granulation w/o flocculation 100 – 200

3+ Turbidity with granulation and flocculation 200– 400

4+ Clumps of protein > 400

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 F. FECALYSIS

Principle

Precautions

Stool is not just a simple waste material. Fecalysis is a test that is done on

feces/stool samples in order to diagnose certain conditions that are affecting the

digestive tract. The routine stool examination includes macroscopic, microscopic, and

chemical analysis for detecting early liver and biliary duct disorders, gastrointestinal

bleedings, mal-absorption and/or mal-digestion syndromes, and causes of diarrhea

and steatorrhea.

Specimen Collection

The accuracy and reliability of the results depends largely on the care taken in

collecting the stools. In preparation, the patient shall not be taking any alcohol, vitamin

C, aspirin, and ibuprofen before the fecalysis as these substances may alter the results

of the test. The patient should urinate before collecting the stool sample to prevent

urine from mixing with the collected sample. The following precautions should be taken

in collecting stool samples for parasitological examination.

1. Collecting sufficient quantity of stool is necessary in order to:

• Allow the detection of parasites; the specimen should also be at least 4 ml.

2. The provision of the container that the patient is going to use; can be light

disposable plastic cup with a lid.

3. Examine the stool samples while it’s still fresh.

a) The stool samples must be examined within one hour after collection

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 b) If a lot of stool specimens are received at the same time, pick and examine

the specimens that contain blood and mucus first, as it may contain motile

amoeba that die quickly.

Precautions

1. Never leave the stool specimens exposed to air in containers without lids.

2. Never accept stool specimens that are contaminated with urine.

PROCESSING

Macroscopic Examination

This starts with the medical technologists observing the stool sample’s

characteristics using the naked eye. They will then record the color and consistency

of the stool. The following are the possible colors, consistencies, and the gross

appearances of the stool:

Table 3.11

Color or Appearance:

Color Consistency Gross Appearance

Dark Brown Hard Conspicuously Fibrous

Black Soft Fiber Scanty to Moderate

Brown Mushy Colloidal (Homogeneous)

Pale Brown Loose Scant Mucus

Clay Diarrheic Much Mucus

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 Yellow Watery (Liquid) Mucus with Scanty Blood

Red-Brown Formed Other (EG: Blood and Barium)

Green, Other Semi-formed NA

Microscopic Examination

This examination is an important step in detecting stool abnormalities and

intestinal problems. Microscopic examination is a diagnostic tool in identifying and

defining protozoa, helminths, and fecal leukocytes.

G. Fecal Smear Preparation

1. Take a slide and place one drop of sodium chloride solution in the middle of

the left half or one drop of Lugol’s solution in the middle of the right half. If

the stool specimen is watery, this is especially done.

2. Using an applicator, take a small portion (about the size O) of the stool. If

the stools are formed, take the portion from well inside the sample to detect

the presence of parasite and ova and from the surface or contains mucus

or liquid.

3. With the drop of the solution at the side, mix the sample.

4. Take a second portion of the stool from the specimen and mix it with the

drop of Lugol’s solution using the applicator.

5. Over each drop, place a coverslip.

6. Examine the preparation under the microscope. Reduce the amount of light

using the condenser aperture or lower the condenser to increase the

contrast, as the eggs and cysts are colorless. (For the saline preparation

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 use 10x and 40x objectives and a 5x or 6x eyepiece; For the iodine solution

preparation, use a 40x objective.)

7. Starting at the top left-hand corner, examine the first preparation with 10x

objective.

Reporting

Gross appearance: Color, consistency, and form; one should take note the

appearance of mucus, blood streak, or fats.

Microscopic Appearance:

1. Trophozoites and cyst are reported as number/hpf.

2. RBC and WBC are reported as number/hpf.

3. Parasites and ova are reported as numbers/lpf.

4. Yeast cells and eosinophils and macrophages are reported as (+), (++),

(+++) and (++++)/hpf.

5. Fat globules are reported as (+), (++), (+++) and (++++)/ lpf.

H. Fecal Occult Blood Test

Principle

This is a procedure that consists of a cardboard slide with guaiac impregnated

paper in a cardboard frame which permits sample application to one side with

development and interpretation on the reverse side.

When a fecal specimen containing occult blood is applied to the test paper,

contact is made between hemoglobin and the guaiac.

A pseudo peroxidase reaction will occur upon the addition of the developer

solution, with a blue chromogen formed proportional to the concentration of

hemoglobins. The color reaction will occur after 30 seconds.

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Patient Preparation

Patients should avoid red meat for three days before and during the stool

collection period.

a) Having a well-balanced diet that includes fibers like bran cereals, fruits and

vegetables that contains peroxidase-like substances (broccoli, cauliflower,

turnips, red radish should be avoided during the test period).

Interpretation:

a) Blue color indicates that there is gastrointestinal bleeding.

Clinical Significance:

a) Bleeding in the upper gastro-intestinal tract may produce a black, tarry stool,

and bleeding in the lower gastro-intestinal tract may result in an overtly bloody

stool.

b) A 150 g of stool with an excess bleeding of 2.5 mL is considered pathologically

significant and no visible signs of bleeding may be present with this amount of

blood. Fecal Occult Blood Testing or FOBT is primarily used to detect

suspected cases of gastrointestinal disease and is also used for mass

screening procedure for early detection of colorectal cancer.

I. Formalin-Ether Concentration Technique (FECT)

Principle

Fecal concentration has become a routine part of the ova and parasite

examination that allows the detection of the small numbers of microorganisms that

may be missed by using a direct wet smear. In order to concentrate the protozoa,

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helminth, ova, and larva in the bottom of the tube, the sedimentation method used is

centrifugation. To extract the debris and fat from the feces, Ether was used.

Specimen Rejection

Stool specimens contaminated with water, urine, soil, or other extraneous

materials shall be rejected.

Materials & Reagents

a) 0.85% Saline solution

b) 0% Formalin

c) Centrifuge

d) Centrifuge tube

e) Lugol’s iodine

f) Applicator sticks

g) Disposable pipettes

h) Cheese cloth or strainer

Procedure:

1. Mix the specimen well.

2. Through wetted cheesecloth over a disposable paper, funnel into a 15 ml

conical centrifuge tube, then strain 5 mL of the fecal suspension.

3. Wash the fecal sediment with NSS (or water) 3 times by repeated mixing,

centrifuging, and decanting.

4. Add 10% Formalin through the debris on the gauze to bring the volume in the

centrifuge tube to 15 ml. Distilled water may be used.

5. Centrifuge at 500 rpm for 10 minutes.

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 6. Decant supernatant. Add 10 ml of 10% formalin to the sediment and mix

thoroughly with wooden applicator sticks.

7. Centrifuge at 500 rpm for 10 minutes (after centrifugation, solution will form four

layers).

8. Free the plug of debris from the top of the tube by ringing the sides with an

applicator stick. Decant the top of the layers of supernatant.

9. Add several drops of 10% formalin to re-suspend the concentrated specimen

for pipetting.

10. Place fecal sediment on the slide, place cover slip. Examine under LPO & HPO

(A small drop of 2% Iodine Solution may be used to stain protozoan cyst).

J. Kato-Katz Technique

Principle

Kato-Katz is used for quantitative and semi quantitative diagnosis of intestinal

helminthic infestations that are caused by: Ascaris lumbricoides, Trichuris trichiura,

Hookworm, and especially the Schistosoma spp.

a) People infected with STH or intestinal schistosomes pass the eggs of the

worms through their feces. By examining a stool sample under a microscope,

it is possible to count the number and the type of eggs that are present (WHO,

Action against Worms 2008).

b) In this technique, stool samples are pressed through a mesh screen to remove

the large particles. The portion of the sieved stool sample will then be

transferred to the hole of a template on a slide. After filling it, the template will

be removed and the stool sample will be covered with a piece of cellophane

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 soaked in glycerol solution. This solution will clear the fecal material from

around the egg. The eggs are then counted per gram of the feces.

Material

a) Kato-set (Template with a hole, nylon or plastic, screen, plastic spatula)

b) Glass slides

c) Newspaper or glazed tile

d) Cellophane soaked in Glycerol-malachite green or glycerol-methylene blue

solution as a cover slip

e) Fresh stool

f) Gloves

Procedures

1. Label a glass slide with the sample number and then place a plastic template

on top of it.

2. Place a small amount of the fecal sample on a newspaper and press a piece of

nylon screen on top. Using a spatula, scrape the sieved fecal material through

the screen so that only the debris remains.

3. Scrape up some of the sieved feces to fill the hole in the template, avoiding air

bubbles and levelling the feces off to remove any excess.

4. Carefully lift off the template and place it in a bucket of water mixed with

concentrated detergent so that it can be reused.

5. Place one piece of the cellophane, which has been soaked overnight in

methylene blue glycerol solution, over the fecal sample. Then, using a circular

motion, press the top slide firmly onto the bottom slide to spread the stool in an

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 even circular layer. If done well, it should be possible to read newspaper print

through the stool smear.

6. Place a clean slide over the top and press it evenly downwards to spread the

feces in a circle. Carefully remove the slide by gently sliding it sideways to avoid

separating the cellophane strip. If done well, it should be possible to read

newspaper print through the stool smear. Place the slide with the cellophane

upwards.

7. If hookworm is present in the area the slide should be read within 30– 60

minutes, irrespective of the technique used. After that time, the hookworm eggs

disappear.

Examination & Results

Place the slide under a microscope and examine the whole area in a systematic

zigzag pattern. Record the number and the type of each egg on a recording form

alongside the sample number. Finally, multiply the number of eggs by the appropriate

number to give the number of eggs per gram (epg) – the standard measurement to

assess the intensity of infection.

K. SPERM FLUID ANALYSIS (SFA)

Procedures:

1. Specimens are collected by self-simulation into sterile containers ( On-site).

2. It may also be collected at home using special condoms from healthcare

practitioners.

3. In infertility testing, samples must be analyzed within one hour.

4. Two separate collections on two separate days may be required.

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Clinical Significance:

It determines the reason why couples are having difficulty in conceiving; it is

also the easiest test that can evaluate a male's fertility.

IMMUNOLOGY & SEROLOGY SECTION

The immunology & serology section in PROVIDENCE MEDICAL

LABORATORY may provide a far reaching and exceptional range of testing for

multiple illnesses. These include infectious diseases, fertility hormones, and other

autoimmune disorders. The laboratories are known for well- designed equipment for

automated immunology analyzers. The laboratory services may ensure that the right

results are obtained in the patients. Precise and accurate results by the process of

internal quality control and external quality assessment are defined in the services in

clinical immunology.

1. HLA (Human leukocyte antigens) Typing

Principle

The principle of human leukocyte antigen typing (HLA) is to determine which

person can provide the safest tissue transplant such as hematopoietic stem cell

transplant. Potential tissue recipients must have the typing in order to closely match

the patterns of each.

HLA can be tested in two ways:

1. A blood test

2. A swab of your cheek

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The process of HLA typing

HLA is a genetic test. This is usually from a swab inside your cheek or even

from the blood sample drawn from the vein of your arm. The sample will be needed to

be sent to a specialized center for analysis.

Interpreting results

After the laboratory receives your HLA test sample, it usually takes about 1 to

2 weeks for your results to come back. If your results show that your pattern of HLA

markers is like the patient’s, this means you’re a potential donor.

The HLA proteins have its highly technical names. The doctor may provide the

specific information about the HLA type compared to the potential donor. The results

from the HLA typing are not likely to mean much to you on their own.

i. HbsAg Test

Principle

The main principle of the assay may serve as the aid for the clinical diagnosis

and detection of Hepatitis B infection. A one step HbsAg test is based on the principle

of double antibody sandwich immunoassay determination of HbsAg in serum plasma.

One step is very sensitive and may last up to 10 minutes that is usually where

the results may be read. Accuracy of HbsAg test; The overall pooled clinical sensitivity

and specificity of rapid HbsAg tests were 90.0% as being compared to the laboratory-

based immunoassay reference standards.

Procedures of HbsAg Test using cassette test

1. Allow test device, specimen and other controls to equilibrate to room

temperature (15-30°C) prior to testing.

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 2. Remove the test device from the sealed pouch and use it as soon as possible.

Best results will be obtained if the assay is performed within one hour.

3. Place the test device on a clean and level surface. Hold the dropper vertically

and transfer 3 drops of sample (probably 120μL) to the specimen well of the

test device and then start the timer. Avoid trapping air bubbles in the specimen

well.

4. Wait for the red line to appear. Depending on the concentration of HBsAg,

positive results may be observed in as short as 60 seconds. However, to

confirm negative result, the complete reaction time of 30 minutes is required.

Sample & Test

1. Serum & Plasma

2. A simple and rapid test cassette

Specimen collection & Preparation

Serum is obtained following regular clinical procedures.

1. If the specimen is not tested the same day as collected, it should be stored &

refrigerated.

2. If the storage period is greater than 3 days, serum should be frozen. It should

be prevented to thaw and refreeze the collected specimens.

3. Samples that have been stored over a longer period or had been frozen should

be mixed before use.

Interpreting the results

POSITIVE: Two distinct red lines appear. One line should be in the control region and

another line should be in the test region.

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 a) A red test result line in the T region indicates that the sample contains hepatitis

B surface antigen (HBsAg).

b) The color intensity of the test result line may vary from faint pink to an intense

burgundy.

NEGATIVE: One red line appears in the control region. No apparent red or pink line

appears in the test region.

The absence of a line in the test result line region indicates that no hepatitis B

surface antigen (HBsAg) is detected.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect

procedural techniques are the most likely reasons for control line failure.

2. SYPHILIS

Principle:

The Syphilis Test is a qualitative membrane device-based immunoassay for the

detection of TP antibodies in whole blood, serum or plasma. In this test procedure,

recombinant Syphilis antigen is immobilized in the test line region of the device.

Samples for testing

a) Blood testing

b) Body fluid samples

c) Tissue samples

Methods

Screening tests for syphilis:

1. Rapid plasma reagin (RPR) - a syphilis blood test that looks for antibodies to

the syphilis bacteria.

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 2. Venereal Disease Research Laboratory (VDRL) - These reaginic antibodies,

while almost always produced by patients with syphilis, may also be produced

by patients with other infectious diseases, autoimmune disorders, pregnancy,

old age and recent immunization. Positive screening in this category should be

confirmed.

3. Treponema Pallidum-Particle Agglutination (TP-PA)- are used to confirm

positive screening tests, or occasionally as confirmation when other test results

or clinical symptoms warrant additional testing.

Procedures:

1. Obtain 5-10 ml of blood from the patient using standard venipuncture technique.

Collect the blood into an anticoagulant free tube or serum separator tube (SST).

Plasma may be used up to 48 hrs. from collection.

2. Label tube with patient’s full name, date and time of collection.

3. Complete the test requisition form or order request online through our

Laboratory Information Management System (LIMS). Specimens and forms

should be placed in a designated location at each site for the lab courier to pick

up.

4. Allow specimens to clot and label with a unique identifier to match requisition

form. Wherever a centrifuge is available, specimens should be spun on the

same day of collection. Arrange for transport to laboratory. If transportation is

delayed, refrigerate the tube to minimize hemolysis.

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Reporting and Interpreting results

The presence in the test in its region may provide an indication of results which

may be positive while the absences may indicate a negative result. A colored line will

appear in the region of the control line that ensures that the specimen has been added.

3. Gram staining

Principles

This test differentiates the bacteria into gram positive and gram negative

Bacteria, which helps in the classification and differentiations of microorganisms.

Materials

1. Crystal Violet which acts as the primary stain

2. Iodine, the mordant

3. A decolorizer made of acetone and alcohol (95%)

4. Safranin, for the counterstain

5. Coverslips

6. Glass slides for microscopes

7. Bacterial cultures.

Equipment

• Light microscope with 100x oil immersion objectives

Procedure of Gram stain

Preparation of slide

1. Apply a smear of bacteria on to a slide.

2. Add about 5 drops of Hucker's Crystal Violet to the culture.

3. Add about 5 drops of iodine solution to the culture.

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 4. Tilt slide and decolorize with solvent which contains acetone-alcohol solution

until purple color stops running.

5. Add about 5 drops of Safranin.

Gram staining

1. Apply a primary stain (crystal violet) to a heat-fixed smear.

2. The addition of a mordant (gram's iodine).

3. Rapid decolorization with alcohol, acetone, or a mixture of alcohol and acetone.

4. Counterstaining with safranin.

Reporting of results

When the stain is being mixed with bacteria in a sample, the bacteria will either

stay purple or turn pink or red. If the bacteria stay purple, they are gram-positive. They

are gram-negative if the bacteria turn pink or red.

4. AFB Staining

Principle of AFB Staining

The Ziehl-Neelsen stain also known as Acid Fast Bacilli (AFB) uses a

compound to stain the cell wall of Mycobacterium species. It has the fact that mycolic

acid in the cell wall of AFB renders them resistant to decolorization with acid alcohol.

Mycobacterium does not bind readily to simple stains and therefore the use of heat

along with carbol fuchsin and phenol allows penetration through the bacterial cell wall

for visualization. The main aim of this staining is to differentiate bacteria into acid fast

group and non-acid fast groups.

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Sample collection & preparations

Process of AFB staining

1. Prepare bacterial smear on a clean and grease free slide, using sterile

technique.

2. Allow the smear to air dry and then heat fix.

3. Cover the smear with carbol fuchsin stain.

4. Heat the stain until vapor just begins to rise. Do not overheat.

5. Allow the heated stain to remain on the slide for 5 minutes.

6. Wash off the stain with clean water.

7. Cover the smear with 3% v/v acid alcohol for 5 minutes or until the smear is

sufficiently decolorized.

8. Wash well with clean water.

9. Cover the smear with malachite green stain for 1–2 minutes, using the longer

time when the smear is thin.

10. Wash off the stain with clean water.

11. Wipe the back of the slide clean and place it in a draining rack for the smear to

air-dry.

12. Examine the smear microscopically, using the 100X oil immersion objective.

Manner of reporting

A normal result for an acid-fast bacteria smear is negative, so that means there

is no presence of bacteria found in the sputum sample. A positive result means that

bacteria were found and that you may have an infection.

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 5. KOH staining

Principle

KOH staining is based on the different selections of bacterial cell walls. The

preparation of KOH is used for the rapid detection of fungal elements in the clinical

laboratory as it is being collected and more visible in during the microscopic

examination.

Method

Simple skin scraping and swabbing exam or skin lesion examination.

Procedures of KOH in the laboratory

1. Place a drop of KOH solution on a slide.

2. Transfer the specimen (small pieces) to the drop of KOH, and cover with glass.

3. Place the slide in a petri dish, or other containers with a lid, together with a

damp piece of filter paper or cotton wool to prevent the preparation from drying

out.

4. As soon as the specimen has cleared, examine it microscopically using the 10X

and 40X objectives with the condenser iris diaphragm closed sufficiently to give

a good contrast. If too intense, a light source is used, the contrast will not be

adequate and the unstained fungi will not be seen.

Procedures in preparation of 100 ml of KOH 20% w/v solution:

1. Weigh 20 g potassium hydroxide (KOH) pellets.

2. Transfer the chemical to a screw-cap bottle.

3. Add 50 ml distilled water, and mix until the chemical is completely dissolved,

add remaining distilled water and make the volume 100 ml.

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 4. Label the bottle and note it as corrosive. Store it at room temperature. The

reagent is stable for up to 2 years.

Results

Normal results indicate that there is no fungus present in your skin sample. This

means your skin rash is not being caused by a fungal infection, but rather by something

else. Abnormal results mean that fungus is present, and your skin rash is being caused

by a fungal infection. A KOH test can confirm the presence of dermatophytes, which

include epidermophyton, trichophyton, and microsporum. It can also be used to test

for Candida albicans. This same yeast that causes oral thrush and vaginal infections

can cause raised, itchy skin rashes as well.

L. HIV Rapid testing

i. Rapid Oral Test

Principle

Rapid tests may look like the simplified version of antibody ELISA tests. The

antibody test may be purchased over- the- counter (OTC) and a single use of

qualitative assay. They look for HIV antibodies in the blood. The test kits may contain

a test swab that may collect oral fluids for the sample collection.

Procedures

Most tests for HIV antibodies are by taking a prick of blood from the finger.

These tests are only accurate three months after exposure.

Reporting of results

Rapid blood tests show two lines if positive or one line if negative, it is much

similar as a pregnancy test.

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 M. Agglutination Test

Principle

Agglutination tests are widely used in underdeveloped countries that may lack

appropriate facilities for culturing bacteria. For example, the Widal test, used for the

diagnosis of typhoid fever, looks for agglutination of Salmonella enterica subspecies

type in patient sera. The Widal test is rapid, inexpensive, and useful for monitoring the

extent of an outbreak; however, it is not as accurate as tests that involve culturing of

the bacteria. The Widal test frequently produces false positives in patients with

previous infections with other subspecies of Salmonella, as well as false negatives in

patients with hyperproteinemia or immune deficiencies.

Procedures

Similar to techniques for the precipitin ring test and plaque assays, it is routine

to prepare serial two-fold dilutions of the patient’s serum and determine the titer of

agglutinating antibody present. Since antibody levels change over time in both primary

and secondary immune responses, by checking samples over time, changes in

antibody titer can be detected. For example, a comparison of the titer during the acute

phase of an infection versus the titer from the convalescent phase will distinguish

whether an infection is current or has occurred in the past. It is also possible to monitor

how well the patient’s immune system is responding to the pathogen.

Manner of Reporting

Agglutination tests are limited by the fact that patients generally do not produce

detectable levels of antibody during the first week (or longer) of an infection. A patient

is said to have undergone seroconversion when antibody levels reach the threshold

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for detection. Typically, seroconversion coincides with the onset of signs and

symptoms of disease. However, in an HIV infection, for example, it generally takes 3

weeks for seroconversion to take place, and in some instances, it may take much

longer.

Clinical Significance

Particle agglutination test

1. Agglutination of an artificial carrier particle with specific antigen bound to its

surface

a) Size of the carrier enhances the visibility of agglutination.

2. Examples include

a) Latex particles: Latex agglutination test

b) Treated Red blood cells; Hemagglutination

c) Whole bacterial cells

3. Reaction is dependent on

a) Amount and avidity of antigen bound to carrier

b) Time of the incubation with specimen

c) Environment of interaction (pH, Protein concentration, etc).

Bacterial agglutination test

1. Measure the antibody produced by the host against bacterial agglutinins

2. Best performance when used in sterile physiological saline.

Uses:

Disease diagnosis: bacterial agent is difficult to cultivate in vitro. Some examples of

such diseases are:

1. Tetanus: Clostridium tetani

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 2. Yersiniosis: Yersinia pestis

3. Leptospirosis: Leptospira spp.

4. Brucellosis: Brucella spp.

5. Tularemia: Francisella tularensis

Slide Agglutination test

1. Use of Antisera (Ab)

a) Used to identify Salmonella and Shigella by causing agglutination of the

organisms

b) Diagnostic purpose (Hospital laboratories): Antisera directed against the cell

wall O antigens of Salmonella and Shigella

c) Epidemiologic purpose (Public health laboratories): Antisera against

flagellar (H) antigen and capsular (VI) antigen of salmonella.

N. ABO BLOOD TYPING

Principle

ABO Blood typing is based on agglutination reaction, agglutination occurs if an

antigen is being mixed with its corresponding antibody.

Procedures:

1. Blood must be drawn from a patient.

2. The blood will be mixed with antibodies that attack types A and B.

3. Sample is checked to see whether or not the blood cells stick together. If blood

cells stick together, it means the blood reacted with one of the antibodies.

4. After a few minutes, the patient's blood type can be determined.

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Reporting of Results:

Table 3.12

ABO BLOOD TYPING RESULTS

Forward Grouping Unknown Reverse Grouping Unknown ABO

Cells Tested Against Cells Tested Against Group

Anti-A Anti-B A Cells B Cells

0 0 + + O

1 0 0 + A

0 + + 0 B

+ + 0 O AB

PROCEDURES FOR RECEIVING REQUEST FORM

All request forms must be submitted to a significant person in the laboratory

with authority. This form must be completed and filled with the appropriate label and

information before submitting it to the receiving department. The receiving authority

will verify the forms for verification. These must be submitted to the department

wherein the availability of tests is possible.

Requesting Procedures:

a) All requests to the laboratory must be made through the use of the laboratory

request form.

b) The lab form must be correctly filled out and signed by the requesting physician

or significant others.

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 c) The patient identification on the request form must correctly match the

identification on the specimen.

d) For STAT or urgent test requests the person ordering the test must clearly

indicate by ticking the STAT or URGENT box on the request form.

The request form should be filled up as follows:

It is imperative that the request form be filled out accurately. Filling out the form

correctly provides the lab with key information that would help in the proper test

selection and further workup of patient specimens as well as in the interpretation and

reporting of lab results. In filling out the request form the following information must be

included:

a) The client’s first name and last name and initials

b) The client’s date of birth using the format DD/MM/YYYY

c) The client’s sex

d) The name of requesting physician /signature

e) Type of specimen and the date and time of collection

f) Test / investigation required

g) Clinical details / diagnosis, any medication or treatment administered to the

patient.

PROCEDURES FOR ROUTINE PERFORMANCE

Performance of Different Departments

All departments must follow the standard procedure of the laboratory as

prescribed by the Department of Health procedure and coordinated to a standard

protocol of health.

Emergency Guidelines for Every Department

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 A. Reception Area

All unidentified information must be verified immediately before submitting to

different departments and consulted by the head of department or head medical

technologist. Patients' issues must be addressed immediately to the head department.

B. Phlebotomy

When having difficulty finding the veins, Patients have dizziness during the

performance or the patients are having difficulty or are afraid in the procedure.

C. Clinical Microscopy

If crystal or cast is found in the urine of the patients, another variant of urine disease

such as immature cells or unstructured cells or either malignant body fluid found in the

body fluid test and another type or unidentified bacteria found in the fecalysis test all

must be reported immediately to the attending head medical technologist.

D. Hematology

All post and pre analytical errors in the hematology section must be reported

immediately to the attending head medical technologist for verification

E. Clinical Chemistry

All post and pre analytical errors in the clinical chemistry section must be reported

immediately to the attending head medical technologist for verification.

PROCEDURES FOR REPORTING OF RESULT OF EVERY DEPARTMENTS

A. Hematology

• Must be reported within 2 hours of blood collection

B. Clinical Microscopy

• Must be reported within 1 hour of collection

C. Clinical Chemistry

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 • All samples collected within a time frame, for example, 9 am results should be

reported at 1 pm immediately.

D. Blood Banking

• Must be reported 2 hours after collection

3.5 Clinical Consultative services

Providence Medical Laboratories offer a consultative clinical service that

provides the best quality and standard for patient care. We are providing you with the

best process and outcome of your different tests within our laboratory premises. The

consultative services are open to all with concerns.

For consultations, you may go to the reception area for registration reservation

and appointment must be via telephone call.

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GROUP OF STANDARDS NO.4
MONITORING PERFORMANCE

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4. MONITORING PERFORMANCE

To assess the quality of performance, the Providence Medical Laboratory

(PML) must have a collection, confirmation, and examination procedure. Changing the

plans and making better use of the resources that are required to track the results.

Monitoring Performance should be checked and adjusted on a regular basis. The

Monitoring Performance document should be a working document that can be used to

provide direction and to evaluate performance at regular intervals.

4.1 Internal Quality Control (ICQ) Program

Equipment must be closely monitored to ensure that it performs at a certain

level. Important, so that incubator temperatures, pipette precision, and ambient

conditions, among other things, are all measured and documented at regular intervals.

Furthermore, in ordinary pathology laboratories, methods for evaluating one's own

performance on a daily basis are typical, and normally take the form of assessing an

aliquot of a sample from a storage pool. The resulting values should then be within

acceptable variation limits. Many of the processes used in assisted reproduction

laboratories were considered more art than science, and as a result, they were not

subject to criticism or evaluation.

Procedures for Quality Control

Patient sample testing in the lab can be a time-consuming process, clinical

examination, microbiological study, or blood banking other aspects of the clinical

laboratory include testing. One of the most significant aspects of laboratory testing is

quality control (QC), which ensures the precision and accuracy of patient sample

results. The integrity of quality control samples is critical for both overall quality

management and meeting proficiency testing criteria. QC concerns must be

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addressed in order to identify potential inaccuracies in patient results, such as reagent

matrix effects and testing function calibration misalignment.

Maintaining precise and frequent quality control inspections of laboratory

sample testing is critical for ensuring that patient testing is done correctly and gives

accurate results. When quality control is properly implemented, it can detect and repair

problems in a lab's analytical methods before potentially inaccurate patient findings

are issued. QC testing failure can be caused by "clerical, methodological,

technological, PT materials stability, and random errors," according to Ibrahim et al.1.

Quality control techniques let a laboratory self-regulate its testing and ensure that the

results obtained are correct and precise.

Clinical laboratories streamline the overall quality control process by managing

documents and using a continuous improvement method. The goal of recurrent quality

control testing is to evaluate the precision and accuracy of the outcomes of patient

sample testing. QC samples are intended to be identical and tested. Precision is

defined as the "degree of agreement among repeated measurements of the same

characteristic on the same sample,"3 whereas accuracy refers to how well test findings

match expectations.

4.2 Performance Indicators

The causes of the out-of-control run should be looked into.

The following items should be examined:

The control material's integrity:

a. Examine the expiration date.

b. Examine the appearance

c. Examine for signs of contamination or degradation.

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 1) Function or calibration of the equipment (when was it last calibrated?)

2) Medical Technologist's Technical Procedure

a. Controls management

b. The number of controls

The Levey-Jennings (L-J) chart is one of the most frequent instruments for

tracking laboratory quality control samples. An L-J chart and the Westgard

Rules are commonly used in quality control to verify trends, biases, and errors.

The Westgard Rules look for the predicted normal distribution and calculate the

standard deviations.

Implementing Westgard rules within an L-J chart can identify violations of the

rules-based control limits established for the sample tested. Many laboratories utilize

L-J charts for 14- or 30-day reviews of QC testing. While daily identification of QC

deviations from normal ranges ensures accuracy of sample testing, longer-term

reviews are more beneficial to diagnosing trends and biases in tests that could be

missed on a daily basis. Additional use of the L-J chart without quality control samples

is to utilize patient samples as their own controls. By tracking the running averages of

the patient results, a laboratorian can identify drift or problems with analyzer function

that are not captured by quality control testing. Addressing concerns with QC materials

as well as recall issues are common challenges for laboratory managers.

4.3 PATIENT SATISFACTION

The Providence Medical Laboratory shall conduct assessments and

evaluations to monitor the quality of its laboratory services and satisfy the patient's

requirements. Patient satisfaction is a powerful indicator of a laboratory's quality of

service because it influences clinical outcomes, patient retention, and medical

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malpractice claims. It also has an impact on the timely, effective, and patient-centered

delivery of high-quality health care.

4.3.1 Procedures for Obtaining Evaluation by Patients

The Evaluation of Healthcare Providers and Systems by Patients (CAHPS)

Surveys are industry-standard questionnaires used to evaluate patients at various

moments of care satisfaction and experience In hospitals, the HCAHPS survey is

employed.

4.3.2 Analysis of Patient’s Evaluation Data

A CMS effort that publicly displays hospital star ratings. The overall assessment

for patient involvement is a complete picture of hospital quality. Patient satisfaction is

measured by hospital star ratings.

4.4 Resolution of Complaints

A procedure must be in place at the Providence Medical Laboratory do know how to

handle patient issues and concerns more effectively.

4.4.1 Receiving the Complaint

a) This procedure's implementation is the responsibility of the Technical

Manager.

b) Complaints can be made orally, in writing, or electronically.

c) This information can be obtained via phone, facsimile, or written

communication internal and external consumers' contact or electronic mail

d) Customer complaints about the laboratory's services must be documented.

e) For further action, fill out the Customer Complaint Form (UTL/FO/06-01).

f) A complaint must include the following information:

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 g) Your name, title, department, and, for external clients, the address

(business, organization, or personal) and telephone number email address

of the complainant;

h) The complaint's date;

i) The product or project in question, together with a reference number or a

date applicable;

j) The nature of the complaint, such as service quality, document content, or

disappointing test result.

4.5 Internal Quality Audit (IQA)

Internal Quality Audit (IQA) protocols must be in place. Quality audits are often

conducted at predetermined intervals to ensure that the institution has clearly defined

internal system monitoring methods that are connected to successful actions. This can

assist in determining whether or not the organization follows the established quality

system processes and can include evaluation criteria based on procedures or

outcomes. Implement a systematic, disciplined strategy to evaluate and enhance the

efficacy of risk management, control, and governance procedures in order to achieve

its goals.

Policies and Procedures for Internal Quality Audit

The PROVIDENCE MEDICAL LABORATORY is responsible for establishing

rules and procedures for the laboratory. Internal Quality Audit guarantees that the audit

process is objective and unbiased. Internal audits are carried out at the request of

management and on a regular basis to guarantee that the laboratory's efforts are

worthwhile.

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 The Quality Manager is in charge of coordinating and planning the audits.

Audits are carried out by competent and, ideally, impartial professionals of the conduct

under scrutiny; In the event of non-conformance or audit results, prompt corrective

action is implemented and remedial activities must be maintained; and Follow-up

audits are performed to ensure that the remedial measures taken were effective.

Designation of Internal Quality Audit Personnel

The internal quality audit will be conducted by a skilled and competent Quality

Assurance (QA) Manager or Quality Assurance (QA) Officer from the PROVIDENCE

MEDICAL LABORATORY.

The responsibility of the Quality Assurance (QA) Manager or Quality Assurance

(QA) Officer the following responsibilities:

Establishing, negotiating, and approving internal quality processes, standards,

and specifications;

Identifying client needs and ensuring that they are addressed, as well as

establishing customer service standards;

Specifying raw material quality needs with suppliers, as well as analyzing and

establishing quality and health and safety standards; Ensuring that production

processes adhere to both national and international standards;

Establishing protocols, standards, systems, and procedures with operating

employees; and Writing management and technical reports, as well as charters for

customers calculating the training requirements.

4.6 External Quality Assessment Surveys (EQAS)

Participation in External Quality Assessment Surveys (EQAS) External quality

assessment is a challenge to the effectiveness of a laboratory's quality management

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system. Participation in External Quality Assessments creates a coordination network,

which can be used to strengthen a national laboratory network. Participation in

external quality assessment surveys provides useful documentation and knowledge

that:

a) allows for the comparison of progress and results across different tests

sites;

b) provides early warning of systemic issues associated with kits or operations;

c) provides quantitative evidence of testing quality

d) identifies potential areas for improvement

e) identifies training requirements

The PML submits an application and participates in the External Quality

Assessment. EQAS surveys carried out by the National Reference Laboratories (NRL)

of the Philippine Quality Assurance in Clinical Laboratories Council (PCQACL)

PML shall keep a record of the samples received for EQAS from the NRL/PCQACL

Four (4) surveys (rounds) per year are considered adequate for the majority of

assessments. High-volume analyzers may necessitate additional surveys, whereas

one survey per year may suffice for certain extremely unusual analyses. Laboratories

can choose how much EQA they conduct based on their quality schemes and

standards.

For ongoing performance evaluation, laboratory consistency recommends at least

two (2) assessments per year. As a result, the ADC will conduct two (2) surveys to

evaluate current results.

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GROUP OF STANDARDS NO. 5
QUALITY IMPROVEMENT (QI)
ACTIVITIES

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5. QUALITY IMPROVEMENT (QI) ACTIVITIES

Employees at the Providence Medical Laboratory must participate in programs

that evaluate the consistency and improvement of laboratory work on a daily basis

TLC Quality Improvement (QI) Activities Include:

Clinical auditing is a process of quality assurance that aims to by systematically

reviewing care against explicit requirements and implementing reform, we can improve

patient safety and performance. Every five years for PML during the revalidation

period, the Laboratory's Head encourages employees to complete at least one full

audit cycle (audit; work review; re-audit).

Clinical Outcomes Review to synthesize the literature on health effects a

systematic analysis of intrahospital changes was carried out. Employees are

encouraged to review their health results to demonstrate the consistency of their work.

To be used for revalidation, clinical results must be reliable, attributable, and well

validated.

Case Reviews and Discussions Employees may use case reviews and

discussions as needed as proof of their willingness to improve laboratory work quality

if adequate evaluations and registries are unavailable.

5.1 Management of Quality Improvements Activities

The clinical laboratory will create a written strategy to improve service quality,

accuracy and reliability of results, and patient safety in laboratory operations.

5.2 Identification of Problems and Poor Delivery Services

A system for recognizing difficulties or poor service delivery must be

established by the clinical laboratory.

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5.3 Continuous Quality Improvements (CQI) (Problem-Solving)

Complaints are frequently interpreted as negative criticism of the laboratory's

operations.

Complaints, on the other hand, indicate that customers had negative

experiences with particular areas of the laboratory's services.

Complaints could be about:

Failure to provide a service, an insufficient level of service, discontent with the

Providence Medical Laboratory policies and procedures, treatment by or attitude of a

member of staff; and the Providence Medical Laboratory (PML) failure to follow the

proper administrative process.

The Providence Medical Laboratory (PML) shall keep detailed records of

complaints and negative customer feedback, including all face-to-face, telephone, and

written contacts about complaints and negative comments.

Complaints must include the following information:

A description of the complaints, the items or services that were the subject of

the complaint, the solution sought by the complainant, the deadline for a response,

and any actions taken.

All complaints and difficulties will be noted by the PML. Complaints must be

investigated, and necessary corrective actions must be taken.

5.4 Implementation, Monitoring and Institutionalization

The Providence Medical Laboratory (PML) will form a Quality Improvement

Team to put the recommendations into action, track their progress, and institutionalize

the effective ones. Potential members are encouraged to participate in quality

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improvement activities that bring together practices and other staff members to

consider quality improvement as a team.

The following people should be considered for the Quality Improvement Team:

a) Medical Technologist in Charge;

b) a medical technician;

c) Technicians in the laboratory;

d) a patient advocate;

e) Medical Records Personnel; and

f) Representatives from the community

5.5 Primary Preventive Measures

Administrative Regulations

Administrative controls are hazard control requirements established at the

administrative level to promote laboratory safety (e.g., by the principal investigator,

laboratory manager, laboratory supervisor, department chair, laboratory safety

coordinator, department safety committee, or University Environmental Health and

Safety). Written plans and standard operating procedures, signs, labels, training,

monitoring, work time, personnel substitutes, and the use of a lab partner are all

examples of administrative controls.

Lab Managers, and Lab Supervisors are responsible for:

a) Ascertain that all laboratory employees have received necessary training on

safety and compliance to enable them to carry out their responsibilities safely

b) Ascertain that all laboratory employees have received they have enough

procedural (experiment-specific) training capable of safely carrying out their

responsibilities

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 c) Make experimental procedures and protocols subject to previous approval

design extra controls for specific situations operations or activities that are

dangerous

d) Limit access to regions that are particularly dangerous. There are chemicals

used.

e) Use suitable signage to indicate specific hazards in a given region.

f) Make numerous standard practices for chemical safety and security mandatory.

In the laboratory, good housekeeping must be observed at all times.

Procedural Checks

Procedural controls (also known as work practice controls) are administrative

controls that describe how certain types of chemicals should be handled, as well as

how specific chemical activities should be carried out, in order to reduce dangers. This

Plan's Standard Operating Procedures section covers a variety of general regulations,

requirements, and SOPs that apply to all laboratories. The PI and personnel in each

laboratory are responsible for developing written SOPs for specific experimental

methods performed in their lab.

These procedures must be fully documented and available to authorized people

(incorporated into the laboratory manual or CHP). New employees must be trained by

people who are knowledgeable about the procedures. Before being allowed to

proceed, new workers must be supervised and proficient in performing the procedures.

Engineering Management

Engineering controls include using less hazardous chemicals in an operation,

isolating a chemical operation, enclosing a potentially explosive reaction, or using local

exhaust such as a fume hood for an operation that produces airborne chemicals.

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 They must be completely evaluated and exploited whenever possible as the

first step in chemical hazard control within the laboratory before it is formed.

Personal Safety Equipment (PPE)

The main investigator, lab manager, or lab supervisor is responsible for

ensuring that all laboratory staff are provided with and use proper personal protection

equipment. This equipment must be sufficient to protect employees from chemical

exposure to their eyes, skin, and respiratory system.

5.6 External Quality Assessment (Accreditation)

An external quality assessment of the clinical laboratory is required.

For instance,

If available, accreditation

a) Document the procedure for joining an EQA scheme and, if applicable,

establishing the inter-laboratory comparison scheme if applicable follow the

Master SOP's process for producing a Procedure SOP, and Use the Procedure

SOP template that is connected to the Master SOP.

b) Review and approve the SOP in accordance with the Document SOP Control.

c) Add the SOP to the Read and Understand List and mark which ones you've

read. The

d) SOP must be read by all employees because its contents are important to their

profession.

e) At a weekly staff meeting, present the SOP and identify which employees would

be affected. Members must read the SOP and be informed that they must sign

it. After reading the SOP, go over the Read and Understand List.

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GROUP OF STANDARDS NO. 6
INFORMATION MANAGEMENT

130 | P a g e
6. INFORMATION MANAGEMENT

In order to improve laboratory quality, the PROVIDENCE MEDICAL

LABORATORY information system must evaluate and implement technological

processes and workplace changes. And with that, the PROVIDENCE MEDICAL

LABORATORY will provide data and information services to customers in order to

meet their requirements and needs.

6.1 Customer Relations

The PROVIDENCE MEDICAL LABORATORY will implement Customer

Relationship Management (CRM), which is a system or process that allows

organizations to manage services and retain and strengthen relationships with

customers.

Documents will be provided to customers to inform them of the available options and

services provided by the PROVIDENCE MEDICAL LABORATORY.

Among the documents are:

a) Leaflets

b) Brochures

c) Catalogues

d) Handbooks

The PROVIDENCE MEDICAL LABORATORY has methods/actions in place to

maintain, measure, and ensure customer satisfaction. The actions are as follows:

a) CONFIDENTIALITY

All records are kept confidential and are only available to the patient or his or her

attending physician. Logbooks and other patient-related records are kept in a secure

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area only accessible by staff. Without the patient's consent, the results are not

disclosed to anyone.

b) RESPONSE TIME

If OUR LABORATORY makes a mistake, the best strategy is to immediately call

the customer and explain the clinical laboratory's error and notify them that you are

aware of the problem.

c) RESPECT

Customers should be loved by healthcare workers at the PROVIDENCE MEDICAL

LABORATORY. This is not to say that you will not encounter difficult customers who

will test everyone's patience. However, if you do not have a company philosophy that

respects and appreciates your customers, the opposite tone will infect OUR

LABORATORY's customer interactions.

The PROVIDENCE MEDICAL LABORATORY will propose and implement

methods and actions to promote or improve the level of customer satisfaction

The actions are as follows:

d) Everyday Customer Interaction

PROVIDENCE MEDICAL LABORATORY healthcare workers must demonstrate

that they are listening to customers by taking notes or repeating back what the

customer has said. Take note of their words and tone. Take note of their body

language. Communicate with them in a clear and concise manner. Before responding,

ask clarifying questions to gain understanding.

e) Facilitating Feedback

If the healthcare workers in the TLC don't have a reason to interact with the

customer in person, look for ways to stay in touch and demonstrate care. They must

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demonstrate to them that they are listening and eager to maintain open lines of

communication. By soliciting feedback and using it to inform your business, you will

discover new ways to ensure your company is relevant to them and, hopefully, open

up new lines of profitable opportunity.

6.2 Communication

The PROVIDENCE MEDICAL LABORATORY shall establish and implement a

communication system to ensure effective external and internal communication

among healthcare personnel in the organization on a daily basis in order to increase

productivity, improve the atmosphere within the clinical laboratory, and reduce

conflicts among healthcare workers.

a) External Communication

External communication in the PROVIDENCE MEDICAL LABORATORY shall

include email, posters, advertisements, newsletters, brochures and other forms of

multimedia marketing designed to entice customers, business partners, and suppliers

to enter into profitable business transactions.

b) Internal Communication

The PROVIDENCE MEDICAL LABORATORY's internal communication will

ensure and encourage efficient communication within the clinical laboratory

Communication with various healthcare providers, including multiple associations and

affiliations to improve the laboratory's image.

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 Internal communication channels at PROVIDENCE MEDICAL LABORATORY:

a) Employee Orientation

New Materials Lab employees will receive basic awareness orientation training that

covers legal requirements, roles and responsibilities, operating policies and

procedures, the contents of this laboratory manual, and basic laboratory safety.

b) Reports

Employees must submit a formally written report on a regular basis, action plan,

and communication of necessary information or topics

c) Open Discussion

Employees at the PROVIDENCE MEDICAL LABORATORY is encouraged to

communicate directly with one another on a daily basis in order to share ideas and

information. Meetings. Employees at the PROVIDENCE MEDICAL LABORATORY

meets in groups that usually have a set agenda and may have minutes prepared.

d) Meetings

Meetings are formal methods of directly communicating information that can be

used for a variety of purposes such as coordinating job-related activities, conducting

strategic planning, and discussing critical health and safety issues.

6.3 Documentation and Record Control

The PROVIDENCE MEDICAL LABORATORY must establish a system for

document and record management. These are managed, reviewed, and archived to

ensure security, confidentiality, and loss prevention.

Laboratory records and documents must include, but are not limited to:

QC records: quality manual, IQC register, results of material exchanges

between laboratories, EQAS records, incident book, corrective action reports, stock

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cards and supply records, personnel records such as staff training, competency

records, and health records, complaints and their resolution, notes and minutes of all

formal meetings, inventory (or assets), Request forms, report results and copies,

instrument printouts Laboratory workbooks and worksheets, laboratory registers

(logbooks), calibration records and calculation factors.

The processing and approval of new documents and records will be handled by

PROVIDENCE MEDICAL LABORATORY.

a) Approval of Documents and Records: Prior to issue or release for use, the

approving authority must approve all records and documents in the quality

management system

b) The documents and records are stamped "Approved." "Document" written on

the backside of the paper and signed by the approving authority Document

legibility must be ensured when documents are approved.

c) PROVIDENCE MEDICAL LABORATORY will take action to retain and store

documents and records. The table below will serve as a standard regulation to

be followed by healthcare workers at the PROVIDENCE MEDICAL

LABORATORY, establishing the length of time a specific document and

specimen must be maintained and stored within the laboratory.

TABLE 6.1

DOCUMENT/RECORDS RETENTION

Quality Control Two (2) years

Logbooks One (1) year

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 Laboratory Reports Two (2) years

Requisition Forms One (1) year

Results One (1) year

Instrument Maintenance Two (2) years

Access to records must be restricted, and data must be protected from

unauthorized access. Medical and laboratory personnel are not authorized to disclose

information to others without the patients' consent, so confidentiality is essential.

To monitor and control the documents and records, PROVIDENCE MEDICAL

LABORATORY will provide two (2) or more logbooks. The following are some of the

logbooks the PROVIDENCE MEDICAL LABORATORY provides:

a) Laboratory Notebook Catalog

Used for documentation and record keeping.

b) Computer Logbook

Every individual who enters the clinical laboratory is required to record

the details of laboratory usage in the Computer Logbook.

6.4 Laboratory Information System

A laboratory information system (LIS) is a software system that records,

analyzes, and reports on laboratory data as well as manages and stores clinical

laboratory data. Traditionally, a LIS has been best at sending laboratory test orders to

lab instruments, tracking those orders, and then recording the results, typically to a

searchable database. This is a useful tool for quickly accessing files, especially in the

clinical laboratory.

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 The PROVIDENCE MEDICAL LABORATORY shall establish a laboratory

information system to process and transmit laboratory examination and other activity

information to customers and other management.

6.4.1 Requests for Laboratory Examinations

The PROVIDENCE MEDICAL LABORATORY will provide a screening action

and process laboratory examination requests to be carried out by healthcare workers.

Proper request forms must be used, and they must include information that allows the

source of the sample (e.g., the patient) and the authorized person requesting the test

to be identified. To aid in the interpretation of the results, clinical information, including

treatment, is required.

Patient identification, gender and date of birth, patient location/source of

specimens, identity of the requesting person, type of sample, examinations (tests)

required, clinical details, e.g., any drugs/antibiotics being given that may have

relevance to the interpretation of results, time and date sample taken, must all be

included on the request form.

6.4.2 Delivery of Results for Laboratory Examinations

The PROVIDENCE MEDICAL LABORATORY shall establish a procedure for

the timely review and delivery of laboratory examination reports to customers, which

will be carried out by healthcare workers. The test results must be reviewed and

authorized by designated personnel. When reporting laboratory results, they must be

legible and free of transcription errors.

Laboratory reports must include the requester's identification, the date and time

of primary sample collection, the type of sample, the date and time of reporting, the

results and units of measurement, the date and time of laboratory receipt, and the

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identity and signature of the person releasing the report. There must be a documented

procedure for reporting urgent results over the phone. Procedures must be in place

for the storage of samples after examination to allow for re-examination (if necessary)

and eventual safe disposal.

Laboratory Reporting of Test Results

Qualified personnel verify laboratory results by the registered physician. All

laboratory results will be verified and signed by the technician. Reporting of test results

using a formatted template approved by the lab's head. Test results are reported using

remote status printers. Printers must produce clear results.

6.4.3 Workloads Report & Other Statistical Report

Maintaining a procedure for reporting workload and other statistical data as we

are aware that the laboratory's data is one of the most important. The aforementioned

reports must be submitted to the DOH and Phil Health.

The PROVIDENCE MEDICAL LABORATORY shall establish a procedure for

the reporting of workloads and other statistical data generated by the clinical laboratory

each day. A logbook containing each type of examination available in the

PROVIDENCE MEDICAL LABORATORY, the frequency of examinations, the date,

and the total number of specimens processed in a day will be counted and tallied.

138 | P a g e
 GROUP OF STANDARDS NO. 7
ENVIRONMENTAL MANAGEMENT
AND BIOSAFETY

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7. Environmental Management and Biosafety

A laboratory safety program’s objective should be to protect those who work in

the laboratory, others who may be exposed to laboratory hazards, and the

environment. Hazardous materials must be handled and disposed of in a way that

protects people, other living organisms, and the environment.

7.1 Sanitation and Cleanliness

All laboratory and office surfaces should be disinfected daily with the provided

spray cleaner, and delicate surfaces should be disinfected with disinfectant wipes by

the laboratory personnel. The surfaces that must be cleaned on a daily basis vary

depending on the laboratory and activity, but may include the following items:

NOTE: The advice provided below is only a suggestion. Please review the other

management's recommendations for the equipment and materials in your lab and

office and modify the disinfection protocols accordingly.

SPRAY CLEANER

a) Benchtops

b) Equipment handles and latches

c) Drawer and cabinet handles

d) Bin and water incubator lids

e) Doorknobs

WIPES

a) Equipment controls and touchpads

b) Hand tools, Micro-pipettes

c) Faucet handles and sprayer grips

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d) Chemical bottles and lids

e) Chair backs and armrests

f) Pens, whiteboard markers

g) Develop a list of additional locations and equipment in the laboratory for

addition to the daily cleaning list.

h) Before using a disinfectant, clean the area with soap and water to remove any

spilled materials or visibly soiled areas.

i) Ascertain that the disinfectant will not react negatively with the chemicals being

used in the targeted areas.

j) Standard household bleach (sodium hypochlorite) has a broad spectrum of

action, but once diluted, it is only effective for up to 24 hours.

k) Do not combine bleach and other cleaning and disinfection products.

l) To avoid damage, handle delicate equipment with care. Some cleaning sprays

may not be safe to use or may cause damage to electronic equipment.

m) While cleaning, wear safety glasses and impervious chemical-compatible

gloves.

n) Cleaning should be done when workers first enter the lab and again just before

they leave.

o) Used wipes and gloves should be discarded in the hazardous waste bin. Each

time an individual leaves the laboratory, gloves must be removed and

discarded.

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7.2 Orderliness and Labeling

7.2.1: LABELING

All containers containing unwanted waste will be labeled with the words Lab

Hazardous Waste. "Lab". All waste containers must have a "Hazardous Waste" label

that includes the following information:

a) Each component in the container for waste must be in a full chemical name

(no formulas, abbreviations, or structures)

b) The containers estimated percentage of each waste component.

c) The start date of the accumulation, when waste was first added to the container.

d) Specify whether the material is common waste (used) or an unused pure

commercial product.

e) The total amount of waste in the container. This is critical information for

inventory tracking. To reduce disposal costs, always use an appropriate size

and fill the container with 10% headspace to allow for expansion

f) The location and source of the waste.

g) The required information can also be "associated with the container," which

means the label attached to the container.

The container itself employs a reference system (e.g., a number or barcode)

that allows the information to be tracked to a log book or electronic database detailing

the contents, generator, accumulation start date, and additional data.

7.2.2: SEGREGATION AND STORAGE

This should happen at the point of production. All employees should be aware

of the various types of waste generated within the practice and receive training on

proper segregation. It is critical that all practices stock appropriate and consistent

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packaging. In allowing various types of waste to be handled, transported, and

disposed of in a safe and consistent manner with the nature of the waste. When waste

is handled properly, the risk of infection spreading is very low.

The lab creates health hazard separation of these wastes through color coding.

The storage facilities used will prevent accidents and illnesses in the hospital

Personnel in charge of the waste management system:

Color coding waste storage to distinguish one type of hospital waste from

another Others include:

GREEN - General Waste

RED - Infected Plastics

YELLOW - Infected Waste

BLUE - Glassware

RED with WHITE TOP – SHARPS

7.2.3: DISPOSAL OF WASTE

a) Healthcare risk waste must be stored in yellow healthcare risk containers

garbage bags

b) Yellow healthcare waste bags should be stored in a rigid foot-operated bin.

c) Use the swan neck sealing method.

d) It is important that clinical sharps bins are not overfilled to avoid sharps injuries,

and when not in use, it should be in the lock position.

e) Sharps bins should be locked, signed, and stored upright in a safe location

awaiting collection

f) It is critical that each healthcare risk waste bag/sharps container be labeled,

tagged and the tag number recorded for traceability and accountability.

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NOTE: The preferred disposal method is incineration, but the hospital does not use it.

However, the Chevalier is the authorized waste collector and is responsible for

transporting and disposing of locally generated waste to a distant appropriate facility.

7.3 SOLID WASTE MANAGEMENT

Solid waste should be placed in a double-lined cardboard box. Liners must be

1.5 mil or higher polypropylene bags. For regular solid waste accumulation, do not use

biohazard or radiation waste bags; instead, labeled clear or black trash bags are

preferred. Individually tie and seal each bag. Ethidium bromide-containing solid and

semi-solid waste (e.g., used gels) should also be collected in double bags within

cardboard boxes. Collect liquid ethidium bromide waste in a separate bottle and

dispose of it properly.

7.4 LIQUID WASTE MANAGEMENT

a) The laboratory is responsible for developing, establishing, and implementing a

system for proper management of liquid waste

b) The laboratory has a procedure in place for the safe handling of hazardous

liquids and chemicals.

c) The treatment and disposal of liquid waste complies with the Department of

Environment and Natural Resources' Environmental Compliance.

MSDS (Material Safety Data Sheet)

A document containing information on potential hazards (health, fire, etc.).

Reactivity and environmental impact), as well as how to work safely with the chemical

product. Knowing what type of chemical, it is and the hazard it poses is the most

secure way to protect yourself. As a laboratory worker, you must treat all specimens

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and reagents as highly infectious and hazardous in order to protect yourself and your

mind at all times.

A. PPE (Personal Protective Equipment)

Employees and students must both wear PPE. PPE includes:

a) Gloves

b) Goggles

c) Respirators

d) Aprons or Laboratory Gowns

e) Closed-toed shoes

f) Long pants, avoid shorts

g) Contain long hair

h) Avoid loose clothing

i) Hood ventilation

B. Basic Hygiene Practices

a) Eating, drinking, using cosmetics, and chewing gum are all strictly prohibited in

any laboratory containing chemical, biological, or radioactive materials. Other

actions must also be restricted by researchers. (Examples include applying lip

balm, rubbing eyes, and using personal electronics.) such as cell phones) that

may inadvertently expose you to materials for research.

b) Using alcohol or illegal drugs in a research laboratory is prohibited. Such

actions are strictly prohibited because they may endanger the health of others

not only of the user, but of everyone in the building Infractions will result in be

subjected to severe disciplinary action.

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 c) All areas require long pants/skirts and closed toe/heel shoes where dangerous

materials are kept and exposed skin should be protected and be kept to a

minimum, especially when working with hazardous materials.

d) Long hair, loose clothing, and jewelry should be kept to a minimum when

working in areas with rotating machinery or near open flames containers for

chemicals put on a belt to secure loose clothing, a more form-fitting coverall or

lab coat.

e) Synthetic clothing should be avoided, especially when working with flammable

materials. If a cotton religious garment is used, a flame-resistant hood can be

added. This is not an option.

C. CHEMICAL HANDLING

a) All containers with chemicals should be labeled.

b) Make sure to put on or wear your PPE like your laboratory gown or coat as well

as goggles to protect your eyes.

c) Do not taste, smell, or inhale chemicals intentionally.

d) Make sure that you avoid direct contact with the chemicals.

e) Hazardous chemicals should be handled correctly and used only as directed.

f) cabinets for acid solutions with concentration more than 6 M. should be

separated

g) All containers should be labeled with the date they were received and when

they were reopened.

h) All containers should have chemical labels with all necessary information.

i) When opening newly received reagent chemicals, read the warning labels

immediately. This will assist you in being aware of any special storage

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 precautions. Such as refrigeration and inert atmosphere storage are two

examples.

j) It is necessary and a must to inspect chemical containers on a regular basis for

rust, corrosion, and leakage.

k) Bottles, especially those that are hazardous and chemicals that absorb

moisture, should be stored in chemical safe bags.

l) To fill a pipette, you must use a pipette bulb or another filling device as mouth

suction is strictly prohibited.

m) In areas where hazardous chemicals are used or stored, smoking, drinking,

eating, and applying cosmetics are all prohibited.

n) Always use chemicals in a well-ventilated area. Consult the MSDS and also the

Standard Operating Procedure to determine what type of ventilation is required

o) When you leave the lab after working with chemicals, wash thoroughly using

soap and water to keep your hands and face clean and free of traces of

chemical substances.

CHEMICAL SAFETY

Toxic effects from hazardous substances

Chemical safety is the practice of using occupational chemical substances in a

way that ensures human safety and health while also preventing environmental

damage. It covers all aspects of chemical use, including chemical manufacturing,

transportation, use, and disposal. Chemical safety consists of several components,

including scientific knowledge of potential hazardous effects, technical knowledge of

safe-handling and use procedures, and effective communication of all substances'

chemical identity and safety profile.

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 Children, pregnant women, and the elderly are at a higher risk as well as

seniors, people with pre-existing medical conditions, and Indigenous peoples.

Accidental or incorrect use of household chemical products can result in immediate

health consequences such as skin or eye irritation, burns, or poisoning. Chemicals

can also have long-term health consequences. When this happens, it is usually the

result of prolonged exposure to certain chemicals.

STORAGE AND HANDLING OF CHEMICALS

There are numerous ways to work with chemicals to reduce the likelihood of an

accident and the consequences of such an accident to a bare minimum. Risk reduction

is dependent on safe practices, appropriate engineering controls, the proper use of

Personal Protective Equipment, the use of the least amount of chemicals necessary,

and the substitution of less hazardous chemicals when possible. Chemical safety is

inextricably linked to other safety concerns.

HAZARD VS. RISK

Although the terms hazard and risk are frequently used interchangeably, there

is a distinction between the two. A hazard is a much more complex concept than a risk

because it involves usage conditions. A chemical's hazard has two components that

must be considered:

Its inherent ability to cause harm due to its toxicity, flammability, explosiveness,

corrosiveness, and other properties.

The chemical's proclivity to come into contact with a person or object of concern.

The combination of the two components determines risk, or the likelihood or

probability that a chemical will cause harm. Thus, if an extremely toxic chemical, such

as strychnine, is sealed in a container and does not come into contact with the handler,

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it cannot cause poisoning: high hazard, low risk. In contrast, a chemical that is not

highly toxic but comes into prolonged contact with the handler's skin can be lethal: low

hazard, high risk.

CHEMICAL SAFETY GUIDELINES

a) Assume that any unknown chemical is dangerous.

b) Understand all of the hazards associated with the chemicals with which you

work.

c) Consider each chemical mixture to be at least as dangerous as its most

dangerous component chemical.

d) Never use a product that has not been properly labeled.

e) Follow all chemical safety precautions exactly.

f) Reduce your exposure to all chemicals, regardless of their hazard rating.

g) Wear appropriate personal protective equipment.

h) Avoid repeated unprotected chemical exposure.

CHEMICAL HANDLING GUIDELINES

When working with chemicals:

a) Remove and use only the amount of chemicals required for the current job.

b) Sealed, labeled, and stored chemicals properly in appropriate containers.

c) Examine stored chemicals for signs of deterioration and broken containers.

d) Store chemicals away from heat, sunlight, or substances that could cause a

dangerous reaction if mixed.

e) Do not pour hazardous chemicals down sink drains.

f) Clean up spills and leaks as soon as possible, using only established spill

procedures.

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 g) Be aware of the emergency procedures that apply to hazardous chemical

exposures and spills.

h) Use only established disposal procedures when disposing of chemicals.

Table 7.1

Hazard Class of Recommended Storage Method

Chemical

Keep in a cool, dry place away from the

Compressed gases
Gases that oxidize. Securely trap or chain cylinders against a
- Flammable
wall or bench.

Keep in a cool, dry place away from the

Combustible gases and liquids. firmly strap

Compressed gases
or connect cylinders in a chain to a wall or a bench
- Oxidizing

Store in a cool, dry area, away from flammable gases and

Compressed gases liquids. Securely strap or chain cylinders to a wall or bench

- Poisonous

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 Store separately in an acid storage cabinet. Segregate

oxidizing acids (i.e., Chromic, nitric, sulfuric, and perchloric

Corrosives - Acids
acids) from organic acids

Store in air-tight containers in a dark, cool, dry area. See

Peroxide-Forming Table 3 for recommended storage time limits.

Chemicals

General Chemicals - Flammable gases

Non-reactive

Store on general laboratory benches or shelving preferably

Oxidizers behind glass doors and below eye level.

Store in a spill tray inside a chemical storage cabinet.

Poisons/Toxic Separate from flammable and combustible materials

Compounds

Store in a separate corrosive storage cabinet. Store solutions

corrosives - Bases of inorganic hydroxides in labeled polyethylene containers.

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 Store separately in vented, cool, dry areas, in unbreakable

Water-Reactive chemically-resistant secondary containers and in accordance

Chemicals with the hazardous nature of the chemical.

Store in a flammable storage cabinet and away from sources

of ignition. Store highly volatile flammable liquids in an

Flammable Liquids
explosion proof refrigerator.

Store in a dry, cool location, protected from water fire

Carcinogens sprinklers.

Label all containers as "Cancer Suspect Agents". Store

according to the hazardous nature of the chemical, using

Teratogens
appropriate security when necessary.

Store in air-tight containers in a dark, cool, dry area. See

Peroxide-Forming Table 3 for recommended storage time limits

Chemicals

SAFE TRANSPORT

Here are the pointers for moving chemicals safely:

a) Never transport visible degrading chemicals or containers. Please notify your

lab manager or principal investigator

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 b) When transporting chemicals, use appropriate, leak-proof secondary

containers to avoid breakage and spillage. An excellent using a special plastic

tote to transport four-liter glass bottles of corrosive substances or solvents

c) Use sturdy carts when moving multiple, large, or heavy containers. Ensure that

the cart wheels are large enough to roll over uneven terrain without tipping or

slipping. Make certain that carts are used for secondary containment. The trays

are liquid-tight, with enough lips on all four sides.

d) Do not transport chemicals during peak periods such as breaks or (for example)

Lunch breaks or class changes in those academic laboratories

e) When possible, use freight elevators to transport hazardous chemicals to avoid

potentially dangerous situations on crowded passenger elevators. Keep in mind

when pressing elevator buttons or opening doors, remove your gloves.

f) Never leave chemicals unattended.

RULES FOR CHEMICAL STORAGE

Chemical storage in a laboratory or stockroom requires care and attention to

detail. It is critical to use containers and common lab equipment correctly.

DO THE FOLLOWING TO SAFELY STORE CHEMICALS:

a) Completely label all chemical containers. We advise including the owner's or

user's name and the date received

b) Designate a specific storage area for each chemical and ensure its return after

each usage

c) Keep odoriferous and volatile toxics in ventilated cabinets. Please consult your

environmental health and safety personnel for more information and for specific

advice

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 d) Flammable liquids should be stored in approved flammable liquid storage

cabinets. In the open room, small amounts of flammable liquids may be stored.

Check. For allowable limits, consult your local authority (e.g., fire marshal,

EH&S personnel).

e) Separate all chemicals, particularly liquids, into compatible groups. Take all

precautions when storing incompatible materials. Make a chemical

compatibility chart for use in the lab and at home Chemical storage areas

f) For corrosive materials, use resistant secondary containers. This protects the

cabinets and will catch any spills or leaks caused by breakage

g) Tightly seal containers to prevent vapors from escaping.

h) Keep chemicals in designated refrigerators. These refrigerators should be

labeled.

i) ONLY CHEMICAL STORAGE—NO FOOD—Never store flammable liquids.

Unless it is specifically designed and approved for use in a refrigerator storage.

For storage, only use explosion-proof (spark-free) refrigerators flammables.

And AVOID doing the following:

a) Large, heavy containers or liquids should be stored on high shelves or in high

places/cabinets. Instead, keep these at or below shoulder level.

b) Leaving bottles on the floor unless they are in a secondary containment.

Keeping chemicals in direct sunlight or near heat sources.

c) Chemical storage in fume hoods. Excessive containers obstruct airflow

performance under the fume hood. Only chemicals that are currently in use

should be included in the hood.

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 d) Keeping items on top of cabinets. Allow for at least 18 inches of clearance

around all sprinkler heads to prevent fire suppression interference systems.

e) Making use of bench tops for storage. These work areas should only have

currently in use chemicals.

f) Indefinite storage of chemicals, Powders cake or harden as a result of humidity.

Chemicals that are liquid evaporate. We strongly advise that all containers be

dated when they arrive in the lab. Checking the expiration dates of all

manufacturers is strictly adhered to pay close attention to anything reactive or

dangerous compounds. Remove any outdated, hardened, evaporated, or

degraded materials quickly.

7.5 FIRE SAFETIES

Fire experience

a) Small bench-top fires in laboratories are not uncommon.

b) Large laboratory fires are uncommon.

c) In labs, the fuel load and hazard levels are typically very high.

d) Labs, particularly those that use solvents in any quantity, have very high flash

fires, explosions, rapid fire spread, and high toxicity are all possible combustion

products (heat, smoke, and flame).

Prevention

a) Work should be planned. The majority of lab fires have been caused by mental

or procedural errors in procedure or carelessness

b) Cut down on materials. Keep in the immediate work area and use only the bare

minimum required for ongoing work but this not only reduces fire risk but also

costs and waste.

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c) Maintain proper housekeeping. Maintain a clean and uncluttered work

environment. Frequently return unused materials to storage as soon as

possible. Keep aisles, doors, and access to emergency equipment are all

unobstructed at all times.

d) Follow proper safety precautions.

e) Properly store solvents.

f) Follow equipment restrictions (for example, keep solvents in a separate

container or refrigerator that is explosion-proof).

g) Maintain existing barriers (shields, hood doors, lab doors).

h) Put on appropriate clothing and personal protective equipment.

i) Try not to work alone.

j) Make a plan. Have an emergency plan in writing for your space and/or

operation.

k) Education. Practice the emergency plan and learn how to use it.

l) The equipment is provided.

m) Emergencies

n) You already know what to do. You tend to do what you have practiced under

stressor planned in advance

o) Locate the nearest fire extinguisher and fire alarm box, exit(s), phone,

emergency shower/eyewash, first aid kit, and so on.

p) Be aware that emergencies are rarely "clean" and frequently involve more than

one type of issue for example, an explosion could cause medical, fire, and

contamination emergencies.

q) Fire safety procedures.

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Notify:

a) Other people in the immediate vicinity (yell)

b) The facility's other occupants (use the fire alarm)

c) Emergency responders (the alarm will do this for you, but a phone call is

preferable and ensures that).

Evacuate:

a) The problem's immediate location.

b) The location where the problem occurred.

c) The structure in which the space is housed.

Isolate:

a) Lower the hood sash, close the lab door(s), and close the corridor doors.

b) TRY TO EXTINGUISH IF SAFE TO DO SO.

Fire extinguishers:

a) An extinguisher is a "First Aid" tool; do not expect it to put out a large fire

b) Only for small, isolated fires. Do not attempt to fight a large fire.

c) Brief duration. Spray for 10 to 30 seconds, depending on size.

d) Limited range. 5-10 feet, depending on size/type

e) Fire first, then flee.

f) Place yourself between the fire and the exit.

g) Extinguisher spare and observer

h) Have a backup observer with a spare extinguisher.

i) If in doubt, leave!

j) If you're unsure whether you can fight the fire, don't.

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How to use a portable fire extinguisher: Remember the acronym, "P.A.S.S."

P ......Pull the Pin.

A ......Aim extinguisher nozzle at the base of the flames.

S ......Squeeze trigger while holding the extinguisher upright.

S ......Sweep the extinguisher from side to side, covering the area of the fire with the

extinguishing agent.

7.6 ACCIDENTS AND EMERGENCY PREPAREDNESS

The laboratory must develop and implement a disaster recovery plan with

laboratory mishaps, natural and man-made disasters, and other types of incident’s

emergencies.

a) Electrical equipment safety training is provided on a regular basis.

b) A procedure for dealing with blood and other bodily fluid spills exists.

c) Case management facilities for specific occupational injuries or illnesses are

available.

d) The laboratory has first-aid facilities and personnel who have received training

in Procedures for emergencies

e) All accidents, no matter how minor, including near misses, are recorded in a

book about mishaps

f) Accident book records are reviewed on a regular basis to determine and to

avoid similar incidents in the future, laboratory SOPs must be modified and

reduce the risks to employees and visitors

g) There is a policy and procedure in place for immunization against preventable

diseases to which employees are susceptible

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 h) Procedures and precautions exist for both natural and man-made disasters.

(Fire, flood, earthquake, vehicular accidents, explosions, and so on) Staff,

patients, and visitors were evacuated from the premises in an emergency.

Emergency and Safety

Every laboratory is equipped with an eyewash station, a drench-style safety

shower, sinks, and a first-aid kit. They must be aware of the location and operation of

this emergency equipment.

General First-Aid Information

a) Eyes: Flush with water for at least 20 minutes.

b) Skin: Wash with soap and water for at least 20 minutes.

c) Inhalation: Move to fresh air; usually in the hallway.

d) Ingestion: Get emergency medical assistance immediately.

Spill and Prevention

Spill prevention and control are critical components of laboratory safety. Spills

in a laboratory setting are typically small in size, but they can still be extremely

dangerous. If the spill is small, it should be contained with the proper protocol (lime,

hazard powder, paper towels, etc.) and cleaned up right away.

Laboratory Training

Laboratory safety training is required for all laboratory personnel before they

are allowed to work in the laboratory. A PowerPoint presentation, a safety video, a

quiz, and a written agreement signed by each student comprise the safety training.

Blood Borne Pathogen Exposure Control Plan

Each employer must have a written policy in place to limit employee exposure.

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Exposure control strategy the plan must be accessible to all employees whose

reasonably anticipated duties may result in occupational exposure to blood or other

bodily fluids or other potentially infectious substances

All employees must be informed about the exposure control plan and have

access to it while at work. At the time of initial work assignment and annually thereafter,

the employee must receive adequate training in all techniques described in the

exposure control plan. All necessary equipment and supplies must be readily available

and regularly inspired.

Unknowingly, clinical laboratory personnel come into contact with materials that

could be biohazardous. In recent years, new and serious occupational hazards to

personnel have emerged, complicating the problem due to a general lack of

understanding of epidemiology, disease transmission mechanisms, or causative agent

inactivation. Because of the constant increase in infectious samples received in the

laboratory, special precautions must be taken when handling all specimens. As a

result, specimens from patients with confirmed or suspected hepatitis, acquired

immunodeficiency syndrome, Creutzfeldt-Jakob disease, or other potentially infectious

disease should be handled in the same manner as other routine specimens. Adopting

a standard precautions policy that treats blood and other bodily fluids from all patients

as potentially infectious is required.

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 BIBLIOGRAPHY

WORLD HEALTH ORGANIZATION. (2011, 0 0). Laboratory Quality Standards

and Their Implementation. Laboratory Quality Standards and Their
Implementation.
https://apps.who.int/iris/bitstream/handle/10665/206927/9789290223979_eng.pd
f?msclkid=7b391911cea511ec926111b51d2ddf1d

Clinical Laboratory Manager Job Description. (2021, October 20). Best

Accredited Colleges; best accredited
colleges.orghttps://bestaccreditedcolleges.org/articles/clinical-laboratory-
manager-job-description-and-information-about-managing-clinical-
laboratories.html#:~:text=Duties%20of%20clinical%20laboratory%20managers
%20include%20managing%20overall,consulting%20with%20principal%20inves
tigators%3B%20and%20assisting%20in%20budgeting.?msclkid=48ec0f48cea8
11ec9f106f17d9e337ad

The Importance of Management Commitment | GrowEQ: ISO systems, Process

Improvement & Management. (2012, October 2). GrowEQ: ISO Systems,
Process Improvement & Management; www.groweq.com.au.
https://www.groweq.com.au/the-importance-of-management-
commitment/?msclkid=4b672aa4cead11ec8839fcd972f85f91

Safety Management - Biosafety In The Laboratory - NCBI Bookshelf. (1989,

January 1). Safety Management - Biosafety In The Laboratory - NCBI
Bookshelf; www.ncbi.nlm.nih.gov.
https://www.ncbi.nlm.nih.gov/books/NBK218637/?msclkid=d60b0769ceb011ec
bfb4eba91525ab8e

University, W. S. (2021, November 30). Standard Operating Procedures and

Guidelines for Cleaning Laboratory Workspace. Office of Environmental Health
and Safety; research.wayne.edu.
https://research.wayne.edu/oehs/cleaninglabsop?msclkid=53516833ceb311ec9
1079b61a0d10283

Laboratory Waste Management Plan. (2020, April 0). Laboratory Waste

Management Plan. https://www.wcu.edu/WebFiles/PDFs/SAFETYOFFICE-
LaboratoryWasteManagementPlan.pdf?msclkid=f2436a6fcec611ecb50a0e3a7d
28b57b

SOP 14 Waste Management. (2022, November 0). SOP 14 Waste Management.

https://www.hse.ie/eng/about/who/healthwellbeing/our-priority-
programmes/hcai/resources/dental/sop-14-waste-
management.pdf?msclkid=02973826cec911ecb087a583c5a9348c

161 | P a g e
What is Chemical Safety? - Definition from Safeopedia. (2018, March 1).
Safeopedia.Com; www.safeopedia.com.
https://www.safeopedia.com/definition/5620/chemical-
safety#:~:text=Chemical%20safety%20is%20the%20practice%20of%20using%
20occupational,the%20manufacture%2C%20transport%2C%20use%2C%20and
%20disposal%20of%20chemicals.

Chapter 6: Chemical Storage and Handling - Emergency Management and

Safety. (2021, March 2). Student Affairs | Emergency Management and Safety;
students.umw.edu. https://students.umw.edu/safety/safety-plan/chapter-
chemical-storage-and-
handling/#:~:text=CHEMICAL%20HANDLING%20GUIDELINES%20When%20wo
rking%20with%20chemicals%3A%20Remove,Check%20stored%20chemicals%
20for%20deterioration%20and%20broken%20containers.

MURILLO, R. J. M., ESCAUSO, E. E. A., MAGSINO, M. J. E., & SANORJO, S. D.

(2016). Manual of Standards on Quality Management System in the
Clinical Laboratory.
GROUP-TRUE-LABORATORY.pdf

BUERGO, J. N. P., LAGAMO, M. D. V., LOPEZ, X. X. B., MIKUNUG, A. M.,

PAYRA, B. C. D., & TAN, D. D. (2021). ACCUCARE LABORATORY AND
DIAGNOSTIC CENTER A MANUAL OF STANDING ON QUALITY MANAGEMENT
SYSTEM IN THE CLINICAL LABORATORY.
LAB.MANUAL-ACCUCARE-DX-CENTER-ST-...-DARD-1-TO-7-APPENDIX-AND-
CVS-1.PDF

AUSTRIA, A. E., CRUS, C. M. U., MAGHINAY, D. J. S., PADERNAL, J. D.,

PRASANPOTJANA, R. B., & VILLAS, J. L. D. (2021). MANUAL OF STANDARDS
ON QUALITY MANAGEMENT SYSTEM IN THE CLINICAL LABORATORY.
El-MediTech-Laboratorio-Lab-Manual_Prelim.pdf

ZUÑIGA, M. L. B., CORPUZ, M., & OSIT, J. M. (2020). STANDARD OPERATING

PROCEDURES OF EVERYDAY AVAILABLE LABORATORY.
EVERYDAY-AVAILABLE-SOP-ZUNIGA-CORPUZ-OSIT-FINAL-
REQUIREMENTS.pdf

162 | P a g e
163 | P a g e