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Far Eastern University

Institute of Arts and Science


Department of Medical Technology

Laboratory Proposal
Healthcare Diagnostics: A Tertiary Clinical Laboratory

Submitted by:

Abanes, Dayne Mariz C. – 2018000121


Delicana, Shara Mae B. – 2018052021
Gaoat, Jurel John G. – 2018028941
Guiyab, Christelle Jewel B. - 2018033391
Medalla Jr., Emerito C. – 2018045481
Ordiz, Johanna Mae A. – 2018052911
Ramasola, Franchesca G. – 2018036421
Ramos, Christian Royce T. – 2018000231
Recio, Jerson A – 2018000161
Zarate, Jahleel Mae R. – 2018009071

Submitted to:

Marc Delvin C. Quero, RMT, M.D.


Course Professor

(11/29/2019)
Chapter I
Mission, Vision, and Core Values

Mission

Committed to uphold the international standards of clinical laboratory services aimed at


diagnosing patients with utmost accuracy, cost-effective medical facilities, and sustain
economic growth while functioning as a learning platform for educational development.

Vision

By 2030, be the premier laboratory within Manila in the pursuit of technological


advancement in the healthcare field, and provide continuous quality improvement to
ensure reliable dissemination of results.

Core Values

Responsiveness – To look for solutions and tackle those matters that are of relevance
to our clients, with utmost punctuality in delivering results.

Inclusiveness – To embolden the participation of all members with interest on our


services.

Service-centered – To create a positive experience for customers by maximizing service


and building relationships.

Excellence – To constantly progress upon our routine of procedural techniques and


quality assurance.
Chapter II
Laboratory Logo

The logo symbolizes the quality services our laboratory offers. The word “care”
was emphasized to promote the sense of community, love and unity to our customers. It
embodies a humanistic culture and ethic, one which is characterized by volunteerism,
support of good causes & involvement in the community. Moreover, a microscope was
also designed to intent its importance in every laboratory testing, and a syringe which is
used to extract fluids to study and diagnose the diseases of our customers.

Healthcare Diagnostics is established to cultivate practices that help the future of


health-related phenomena and studies. As stated in our mission and vision, we intend to
produce quality healthcare services and aspire to be consistent in being instrumental to
the improvement of health for our clients. We will be true to our core values ‘RISE’ in
every transaction made and are yet to be done. These can be made possible by tests,
diagnosis, analysis, and research which is tendered based on the needs of those who
need it. Our mindset, creativity, and team strategy is what sets us apart from other
diagnostics laboratory.
Chapter III
Organizational Chart
Chapter IV
Qualifications and Job Descriptions of Staff

Pathologist
- Medical pathologists are physicians who specialize in diagnosing and
studying diseases using laboratory methods. Many of these jobs require
completion of medical school, as well as post-graduate training though
residencies. Licensure is required for all kinds of physicians, and board
certification is available for pathologists. Since many medical pathologists
spend the majority of their time in the laboratory, this career may be best-
suited for individuals who do not desire much patient contact.

Chief Medical Technologist


- Directs and coordinates activities of workers engaged in performing chemical,
microscopic, and bacteriologic tests to obtain data for use in diagnosis and
treatment of diseases: Assigns workers to duties and oversees performance
of tests in fields of microbiology, chemistry, histology, hematology,
immunohematology, and serology. Graduated from a four-year college or
university with major course work in medical technology; and considerable
experience as a medical technologist in the clinical laboratory of a hospital
including experience in the area of assignment; or any equivalent combination
of training and experience. Typically requires 5 years of experience in the
related area as an individual contributor. 1 to 3 years of supervisory
experience may be required.

Medical Technologist (Clinical Chemistry)


- A clinical chemist's job is to evaluate a person's health from their body's
chemistry levels which are acquired through various body fluids. Part of their
job is to monitor quality, assess results, and troubleshoot problems in the
laboratory. They also conduct and analyse research that typically involves
organic, inorganic, and bio chemistry to help improve the diagnosis of a
patient. To be a clinical chemist, you need to have a bachelor's degree in
chemistry or other related field; one can choose to pursue a master's degree
to further widen their field of study.
Medical Technologist (Phlebotomy)
- A phlebotomist must have a bachelor’s degree and is a licensed Medical
Technologist. A phlebotomist’s role is to collect blood from patients.
Phlebotomist is usually trained in venipuncture, capillary collection, patient
care, receptionist duties, sample processing and computer work.

Medical Technologist (Coagulation)


- The role of coagulation analyzer is to perform routine and esoteric
coagulation test. They are responsible for the quality control, instrument
maintenance, and method development to support a broad menu of routine
and esoteric coagulation. As part of their role is to measure the blood’s ability
to clot and how long it takes to form a clot to assess the risk of excessive
bleeding or developing clots. This test will help you to diagnose the acute,
chronic, and inherited bleeding disorders. And in order to be a coagulation
analyzer, you must have one Bachelor’s Degree in Clinical Laboratory
Science or related fields, have at least one year of pertinent laboratory
experience post-BS Degree and previous coagulation experience, has a
knowledge and ability to use laboratory hospitals information systems, and a
certification or eligibility as a Medical Technologist.

Medical Technologist (Immunology)


- The role of the immunologist is to study how the immune system works to
diagnose, prevent and treat patients with immunological disease such as
allergies and other disorders. They are also responsible for finding and
applying alternative solutions to diseases influencing the immune system. In
line with this, they usually work in a wide range of setting including hospitals
and clinical laboratories. This requires Bachelor’s Degree in Medical
Laboratory Science with a year of experience specifically in the field of
immunology section in a laboratory.
Chapter V
Laboratory Design

Chapter VI
Laboratory Services

Blood bank Section

Clinical laboratory services offered:

 Blood donation & collection


 Antibody (Ab) screen (indirect antiglobulin test)
 Direct antihuman globulin test (DAT) or direct Coombs
 Group and type test
 Panel test
 Type and crossmatch (T & C)
 Type and screen

Phlebotomy Section

Clinical laboratory services offered:

 Routine adult and pediatric venipuncture or capillary collections


 Blood culture collection
 Blood bank specimen collection
 Regular blood testing

Hematology Section

Clinical laboratory services offered:

 Complete Blood Count or CBC (available in STAT)


o Hemoglobin Mass Concentration
o Erythrocyte Volume Fraction (Hematocrit)
o Leucocytes Number Concentration (White Blood Cell or WBC Count)
o Leucocytes Type Number Fraction (Differential Count)
o Red blood cell (RBC) count
o Qualitative Platelet Determination
 Blood typing
 Body fluid analysis
 Bone marrow testing
 Automated variant hemoglobin and thalassemia analysis
 Automated and manual coagulation testing
 Automated and manual platelet function testing
 Sickle cell screening
 Tests for inherited red and white blood cell disorders

Microbiology Section

Clinical laboratory services offered:

 Culture and sensitivity (C&T)


 Blood culture
 Acid fast bacillus (AFB) culture
 Fungal culture
 Gram stain
 Occult blood test
 Ova & parasites (O&P)
 Bacterial culture
 Amoeba
 Influenza A&B
 Malaria
 Parasite screen
 Scabies identification
 Worm identification
 Tissue parasites
 Neisseria gonorrhea (GC) Culture
 Leukocytes (WBC), Stool
 Group A Streptococcus Screen
 Group B Streptococcus Culture
 Anaerobic culture
 Blood parasites
 Helicobacter pylori Culture
Immunology Section

Clinical Laboratory Services offered:

 Allergen Testing
 Immunoglobulins
 Flow Cytometry Services
 Rapid Dengue Test for Dengue Fever (NS1 Ag and IgM/IgG)
 Anti-HIV screening test

Clinical Chemistry Section

Clinical Laboratory Services offered:

 Routine Chemistries
 Electrolytes
 Creatinine
 Liver function
 Glucose
 Proteins
 Urinalysis usually 24-hour sample urine
 Clinical mass spectroscopy

Histology Section

Clinical Laboratory Services offered:

 Routine Tissue processing


 Performing special stain
 Giemsa
 Reticulin
 Periodic acid–Schiff
 Mucicarmine
Coagulation Section

Clinical Laboratory Services offered:

 Prothrombin time
 Fibrinogen Level
 Bleeding time
Chapter VII
Work Flow, Quality Control and Quality Assurance Protocols

Clinical Laboratory Workflow

1. Information/Phlebotomy/Specimen Collection
Information area is the reception area of a laboratory where patients’ data are
collected. This is also the area where patients are given a space to wait such as chairs.
Phlebotomy area is the area where blood is drawn by the phlebotomist. It is located
near the waiting area. In this area, there should be restrooms. This is to allow urine
specimen collection. Phlebotomy must be at the entrance area of the laboratory. This is
to prevent intrusion from other patients and staffs.

2. Blood Bank
Blood Banking is the process where blood that is donated or blood products are
safe before blood transfusion. Bloods from blood donations are gathered and stored in
blood bank section. It is located in the middle of the laboratory to prevent patients or
staff coming in and out.

3. Haematology
Hematology is the area in the laboratory which studies blood, blood forming
organs and blood diseases. It also performs various body fluid testing and analysis.
Whole blood is analysed by electronic means and observed microscopically for unusual
cells and infections of the blood. It is usually located beside blood bank section.

4. Clinical Chemistry
In Clinical Chemistry different kind of tests are being used. Clinical Chemistry
may use different kind of body fluid like urine, blood, serum and plasma. It is usually
located at the back part of the laboratory with a room itself. This is to prevent intrusion
from the machines and the staff.

5. Urinalysis
This section of the laboratory is used to look for abnormalities in the urine sample
of a patient. A urine test can help detect kidney or urine tract disorders. The main
purpose accomplished in this area is the biochemical study and microscopic analysis of
urine.
6. Fecalysis/Parasitology
Fecalysis or stool analysis is a test on a stool sample to diagnose conditions
affecting the digestive tract, nutrients on the body and others.

7. Microbiology
Microbiology is a place in a laboratory where microbes grow. Microbiology helps
in diagnosis in certain diseases. A section of the clinical laboratory that analyzes and
tests bacterial, fungal, and viral microorganisms at their various cellular levels in a
patient for identification and for therapeutic antibiotic effectiveness in treatment of
infection. Microbiology typically would consist of virology, mycology, parasitology, and
bacteriology Consideration should be made for microbiology testing and procedures by-
products, such as odors and contaminates, as they could affect the rest of the clinical
laboratory. This is why Microbiology section should be located in an isolated area, but
still near the central core.

8. Histopathology
This section examines biological diseases using interpretation of cells and tissue
samples. A section of anatomic pathology that analyses and tests tissue to distinguish
change characteristics of malignancy and disease. Histology uses a number of different
methods including tissue dissection, chemical staining of specimens and slides,
processing microscopic slides to relay to a pathologist for analysis and diagnosis.
Together with the microbiology section, histopathology section should be located at the
back of the laboratory to prevent contamination and to consider the odor of the
specimen/tissues that can affect the other section of laboratory.

9. Immunology/Serology
Immunology is the section in the laboratory who studies the immune system of
the body. It is responsible for laboratory testing and clinical consultation including
autoimmune disease, immunodeficiency, as well as some aspects of infectious disease
serology. It is usually located near Drug Testing section.

10. Drug Testing


This is the section where specialist looks for presence of illegal drugs in urine or
blood samples.
When it comes to laboratory sections, workflow, connectivity and communication
is important. A clear separation should be maintained when it comes to ingoing and
outgoing of blood.
Immunology and Blood Bank should be separated by product storage or by walls
so that the incoming blood and outgoing blood is also separated. Phlebotomy is
frequently near the reception section of the laboratory. This is to avoid traffic inside the
laboratory and to avoid different bacteria or viruses from the outside.
Microbiology and Histopathology sections should also be separated or away from
other sections. In Microbiology, the specialist culture bacteria which can harm other staff
inside the laboratory. In Histopathology, tissues have this foul smell and the chemical
they use are hazardous.
Other sections in the laboratory should be close to each other, but still insisting
the 3 to 5 feet distance among the work areas and hallways to avoid traffic, spills of
specimens and also accidents.

Quality Assurance
Quality assurance is a practice where services and or products are and offered at
a high quality this also improves the processes to deliver the said Quality Products and
or services to the patient, Quality assurance also ensures that the management system
of a laboratory must be properly maintained. In our laboratory Healthcare Diagnostics
Inc., we ensure that we provide patients and clients with high quality services to ensure
that they will be properly treated in accordance with their concerns and illness’.
In order to ensure that quality assurance is maintained in our laboratory we have
the following procedures. First, documentation, this is a vital part for quality assurance
since this allows us to be able to properly maintain the management system of our
laboratory. Different policies, process’, files, patient logs etc. Without these records,
there might be certain procedures or protocols that will not be followed which can cause
problems within the laboratory. These documents are also used to review the different
laboratory activities done to see if there are necessary changes that are needed to be
made.
Second, the Standard Operating Procedures, this is a set of written procedures
and instructions regarding different process’ and tasks performed within our laboratory.
This ensures that proper handling of specific specimens is done and to prevent
contamination, materials are also handled properly to ensure safety, and proper storage
followed to ensure that reagents and specimens are properly taken care of to prevent
hazards within the laboratory. With this it allows our personnel to properly conduct tests
done with the necessary steps in order to achieve proper patient test results.
Third, the use of Quality Control Samples, in our laboratory these specimens are
treated as normal specimens as if it was collected from a patient, however, these
specimens are mainly to test the procedures done. This allows us to properly test and
evaluate the management system of our laboratory and to see how tests are being
properly done precisely and accurately and make changes when needed.
Lastly, External Quality Assessment, this is a method that tests the quality of the
system in the laboratory by proficiency testing, rechecking retesting, and on site
evaluation, blind samples are used in order to test the performance of our laboratory.
This allows further evaluation on the different areas of our laboratory and to see
whether our procedures, protocols and or personnel are working effectively.
Proper Quality Assurance protocols are strictly followed within Healthcare
Diagnostics Inc. Proper maintenance and proper overall management of our laboratory
are monitored to ensure that the tests conducted, and the services provided to the
patients are of good quality.

Quality Control
Our laboratory offers accurate and reliable results as a by-product of our
excellent quality controls. To define, Quality Control is a component of Quality
Assurance that deals with the process of detecting, reducing, analytical errors ensuring
the accuracy and reliability of tests results in the laboratory. This prevents the incorrect
diagnosis, delay in the treatment, and retesting. This is leaning towards handling of
samples and processes that is performed during examination phase.
Quality control procedures in our laboratory include:
 External Controls, internal controls, electronic controls
 Proficiency testing
 Calibration/verification
 Equipment maintenance
We make sure that our machines are calibrated every start of the shift to confirm
the stability and consistency it provides by running samples that are within and outside
the normal ranges (a.k.a target values). This is then used as a basis of comparison
when actual patient samples are fed into the machine. Then, we interpret the quality
control data by using Levvy-Jennings Chart or the Westgard, which observes the
normal distribution in identifying standard deviations, produced, and can identify
violation of the rules based on control limits that will establish when we are testing the
sample. However, the L-J chart is used to plot the precision and accuracy of the
machine; also a basis whether the result of one specimen is far-off or near the standard
ranges. These records are kept and are used to evaluate and improve our services.

We will give the assurance in maintaining accurate and frequent checks to our
laboratory sample testing through the quality control and vitals of ensuring that all
testing done in the patients is right and produces an accurate result. And by using the
quality control effectively we were able to find and correct all the flaws in the analytical
processes in the lab and prevent the clerical, methodological technical, proficiency
testing materials stability and random errors before patient’s results are released.
Our quality control sample will establish an identical and tested identically to
patients’ samples. For the purpose of repeating quality control testing to validate the
precise and accurate of the results of our patient’s sample testing. We will precisely
repeat the measurements of the same characteristic on the same samples to verify. We
will measure accurately how close the results to what is expected from a test. This
would indicate a low bias result in instrument were using.
Preventive and corrective actions towards systematic and analytical errors are
also provided (i.e. checking of expiration dates of reagents/control, retest of control,
recalibration of methods). Furthermore, Healthcare Diagnostics follows the established
policies and procedures, trains its staffs to conform to these policies, and maintains the
good quality service it provides to its clients.

Chapter VIII
Safety Policies
(Chemical, Ergonomics, and Biohazard)

Blood Bank section


• Allow only authorized person.
• Keep the door of laboratory closed and post biohazard sign.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as:
gloves, laboratory gown, mask and closed shoes.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Exposure to blood borne pathogens should be properly documented and
reported to the concerned authorities.
• Used needles should be disposed in a red puncture-proof container.
• Infectious waste should be disposed in a yellow container.
• General domestic waste should be disposed in a green container.
• Treatment and waste disposal should be done accordingly.
• Do not put biohazardous fluids down the sink.
• Specimen for centrifugation should be properly sealed to prevent leakage.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to infected samples like bag breakage, splash, and needle
stick injury should be immediately recorded and reported to the concerned
authorities and action should be taken based on the guidelines on post –exposure
prophylaxis.
• There should be an approved spill kits in the laboratory.
• Do not pour chemicals down the sink.
• Chemicals must be arranged based on its hazard capabilities.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature.
Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.

Microbiology
• Allow only authorized person.
• Keep the door of laboratory closed and post biohazard sign.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as:
gloves, laboratory gown, mask and closed shoes.
• Laboratory coat should not be worn outside the laboratory
• Hands must be washed before leaving the laboratory.
• Protective eyewear must be worn when performing procedure in the laboratory.
• Long hair should be tied behind the head to avoid contamination of specimen.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Never pipette anything by mouth.
• Infectious waste should be disposed in a yellow container.
• General domestic waste should be disposed in a green container.
• Do not put bio hazardous fluids down the sink.
• Report any broken equipment, especially those containing infectious materials.
• Properly use biological safety cabinet.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• There should be an approved spill kits in the laboratory.
• Do not pour chemicals down the sink.
• Chemicals must be arranged based on its hazard capabilities
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature
• Waste that contains chemicals must be disposed to yellow with black band
container.
• Report any broken equipment, especially those containing infectious materials.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.
• Keep the viewing window of hood/biosafety cabinet clean to reduce eyestrain
and awkward posture.

Immunoserology
• Allow only authorized person
• Keep the door of laboratory closed and post biohazard sign
• Staff must behave in a safe and responsible manner
• No eating, drinking or smoking in the laboratory
• All staff working in the laboratory must wear protective equipment such as:
gloves, laboratory gown, mask and closed shoes
• Laboratory coat should not be worn outside the laboratory
• Hands must be washed before leaving the laboratory
• Protective eyewear must be worn when performing procedure in the laboratory
• Long hair should be tied behind the head to avoid contamination of specimen

Biohazard
• Specimen for centrifugation should be properly sealed to prevent leakage.
• Never pipette anything by mouth.
• Infectious waste should be disposed in a yellow container.
• General domestic waste should be disposed in a green container.
• Any contaminated reusable materials must be decontaminated before reuse.
• Report any broken equipment, especially those containing infectious materials.
• Containers and other equipment which contains specimen should be marked as
containing biohazard.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• There should be an approved spill kits in the laboratory.
• Do not pour chemicals down the sink.
• Chemicals must be arranged based on its hazard capabilities.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature.
• Waste that contains chemicals must be disposed to yellow with black band
container.
• Report any broken equipment, especially those containing infectious materials.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.

Reception/Phlebotomy Area
• The patient, phlebotomists, and laboratory staff are the only ones are the only
one’s allowed to enter the phlebotomy area.
• The phlebotomy area should be easily accessible by the patient, but should have
a clear separation of the reception area.
• Food and drinks are not allowed inside the phlebotomy area.
• All staff performing phlebotomy must wear protective equipment such as gloves,
laboratory gown, mask, and closed shoes.
• The reception area should have a general domestic waste container.
• Proper hygiene must be observed.

Biohazard
• The work area must be disinfected before and after any procedures.
• Any contaminated reusable materials must be decontaminated after use.
• Needle-related injuries should be taken care of immediately and documented and
reported to the concerned authorities.
• Exposure to blood borne pathogens should also be documented and reported.
• Puncture-proof containers should be provided in the work area.
• All samples must be considered infectious and left-over samples should be
disposed in a yellow container.
• Secure each tube containing a blood sample.
Chemical
• Tube with anticoagulants should be up to date.
• Samples should be properly mixed with the appropriate anticoagulant.
• Proper tube order must be observed to avoid cross-contamination.

Ergonomic
• Provide ergonomically designed chairs for the receptionist as well as the
phlebotomist.
• The receptionist should take breaks in-between.
• Comfortable beds or chairs should be provided for the patients partaking any
phlebotomy procedure.
• Provide comfortable benches or chairs in the waiting area.

Blood Bank
• Allow only authorized person.
• Keep the door of laboratory closed and post biohazard sign.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as
gloves, laboratory gown, mask and closed shoes.
• General domestic waste should be disposed in a green container.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Exposure to blood borne pathogens should be properly documented and
reported to the concerned authorities.
• Used needles should be disposed in a red puncture-proof container.
• Infectious waste should be disposed in a yellow container.
• Do not put biohazardous fluids down the sink.
• Specimen for centrifugation should be properly sealed to prevent leakage.
• Containers and other equipment which contains specimen should be marked as
containing biohazard.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to chemicals like bag breakage and splash, should be
immediately recorded and reported to the concerned authorities and action
should be taken based on the laboratory guidelines.
• There should be an approved spill kits in the laboratory.
• Do not pour chemicals down the sink.
• Chemicals must be arranged based on its hazard capabilities.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature
• Waste that contains chemicals must be disposed to yellow with black band
container.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.

Hematology
• Allow only authorized person.
• Keep the door of laboratory closed.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as
gloves, laboratory gown, mask and closed shoes.
• General domestic waste should be disposed in a green container.
• Blood samples and other body fluids must be considered infectious.
• Hand washing must be observed.
• Instrument calibration should be done and documented regularly.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Never pipette anything by mouth.
• Needles and other sharp objects contaminated with blood and other possibly
infectious materials should not be operated in any way.
• Do not flush left-over blood samples down the drain.
• Dispose blood samples in a yellow container.
• Exposure to blood borne pathogens should be taken care of immediately and
documented and reported to the concerned authorities.
Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to chemicals like reagent container breakage and splash,
should be immediately recorded and reported to the concerned authorities and
action should be taken based on the laboratory guidelines.
• Follow all handling and storage requirements for the chemical.
• Do not pour chemicals down the sink.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Label all chemicals correctly, including chemicals in secondary containers, with
the name and concentration of the chemical, preparation or fill date, expiration
date.
• Store alcohol and other flammable chemicals in approved safety cans or storage
cabinets at least 5 feet away from a heat source.
• Use adequate ventilation, such as fume hoods, when working with hazardous
chemicals.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.
• Adjust the position of microscope to your comfortable height.

Microbiology
• Allow only authorized person.
• Keep the door of laboratory closed and post biohazard sign.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as:
gloves, laboratory gown, mask and closed shoes.
• Laboratory coat should not be worn outside the laboratory.
• Hands must be washed before leaving the laboratory.
• Protective eyewear must be worn when performing procedure in the laboratory.
• Long hair should be tied behind the head to avoid contamination of specimen.
• General domestic waste should be disposed in a green container.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Never pipette anything by mouth.
• Incidental exposure to biological substances should be properly documented and
reported to the concerned authorities.
• Infectious waste should be disposed in a yellow container.
• Do not put biohazardous fluids down the sink.
• Containers and other equipment which contains specimen should be marked as
containing biohazard.
• Report any broken equipment, especially those containing infectious materials.
• Properly use biological safety cabinet.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to chemicals like bag breakage and splash, should be
immediately recorded and reported to the concerned authorities and action
should be taken based on the laboratory guidelines.
• There should be an approved spill kits in the laboratory.
• Do not pour chemicals down the sink.
• Chemicals must be arranged based on its hazard capabilities.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature.
• Waste that contains chemicals must be disposed to yellow with black band
container.
• Report any broken equipment, especially those containing infectious materials.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.
• Keep the viewing window of hood/biosafety cabinet clean to reduce eyestrain
and awkward posture.
Clinical Chemistry
• Allow only authorized person.
• Keep the door of laboratory closed.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as
gloves, laboratory gown, mask and closed shoes.
• It is encouraged to wear plastic aprons when working with body samples.
• General domestic waste should be disposed in a green container.
• Samples such as body fluids must be considered infectious.
• Hand washing must be observed before and after testing.
• Instrument calibration should be done and documented regularly.
• Instruments and machines must be handled and operated with care.
• Any accidents in the workplace should be recorded and reported.
• Follow safety standards.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Exposure to pathogens should be properly documented and reported to the
concerned authorities.
• Do not flush left-over samples down the drain.
• Dispose samples in a yellow container.
• Exposure to pathogens should be taken care of immediately and documented
and reported to the concerned authorities.
• Ensure proper sample processing.
• Samples that are done processing should be refrigerated.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to chemicals like reagent container breakage and splash,
should be immediately recorded and reported to the concerned authorities and
action should be taken based on the laboratory guidelines.
• Follow all handling and storage requirements for the chemical.
• Do not pour chemicals down the sink.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Label all chemicals correctly, including chemicals in secondary containers, with
the name and concentration of the chemical, preparation or fill date, expiration
date.
• Keep chemicals away from any machines.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.

Histopathology
• Allow only authorized person.
• Keep the door of laboratory closed.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as
gloves, laboratory gown, mask and closed shoes.
• General domestic waste should be disposed in a green container.
• All biological tissues must be considered infectious.
• Hand washing must be observed.
• Long hair should be tied back neatly, away from the shoulders.
• Avoid placing any object in your mouth - (pencils, pens, fingers etc).
• Cover any open cuts on hands and other exposed skin surfaces and/or wear
gloves.
• No slides or cultures are to be removed from, or brought into the laboratory
without permission of the Laboratory Safety Officer or the Histology teaching
staff.
• Microtomes must be moved and handled with care.
• Instruments used for sample embedding should be operated with care.
• Work in a biosafety cabinet.

Biohazard
• Any biological material used in certain practice must be handles with care.
• Biological wastes should be disposed of into the Biohazard bags provided.
• No slides or cultures are to be removed from, or brought into the laboratory
without permission of the Laboratory Safety Officer.
• Exposure to pathogens should be taken care of immediately and documented
and reported to the concerned authorities.
• Ensure proper sample processing.
• Samples that are done processing should be refrigerated.
• Report any broken equipment, especially those containing infectious materials.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to chemicals like bag breakage and splash, should be
immediately recorded and reported to the concerned authorities and action
should be taken based on the laboratory guidelines.
• There should be an approved spill kits in the laboratory.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature.
• Waste that contains chemicals must be disposed to yellow with black band
container.
• Report any broken equipment, especially those containing infectious materials
• Chemicals used for staining and embedding should be check for their expiration
dates.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
Immunoserology
• Allow only authorized person
• Keep the door of laboratory closed and post biohazard sign.
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as:
gloves, laboratory gown, mask and closed shoes.
• Laboratory coat should not be worn outside the laboratory.
• Hands must be washed before leaving the laboratory.
• Protective eyewear must be worn when performing procedure in the laboratory.
• Long hair should be tied behind the head to avoid contamination of specimen.
• General domestic waste should be disposed in a green container.

Biohazard
• Specimen for centrifugation should be properly sealed to prevent leakage.
• Never pipette anything by mouth.
• Incidental exposure to biological substances should be properly documented and
reported to the concerned authorities
• Infectious waste should be disposed in a yellow container
• Any contaminated reusable materials must be decontaminated before reuse.
• Report any broken equipment, especially those containing infectious materials
• Containers and other equipment which contains specimen should be marked as
containing biohazard

Chemical
• Material Safety Data Sheet must be available in the laboratory
• The laboratory must have Chemical Hygiene Plan
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals
• Accidental exposures to chemicals like bag breakage and splash, should be
immediately recorded and reported to the concerned authorities and action
should be taken based on the laboratory guidelines.
• There should be an approved spill kits in the laboratory
• Do not pour chemicals down the sink
• Chemicals must be arranged based on its hazard capabilities
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature
• Waste that contains chemicals must be disposed to yellow with black band
container.
Ergonomic
• Use ergonomically designed chair
• Store heavy items on lower shelves
• Keep frequently used items within reach
• Use proper sitting posture and positioning
• Take mini break to relieve the body after each task

Urinalysis
• Staff must behave in a safe and responsible manner
• No eating, drinking or smoking in the laboratory
• All staff working in the laboratory must wear protective equipment such as:
gloves, laboratory gown, mask and closed shoes.
• Laboratory coat should not be worn outside the laboratory.
• Hands must be washed before leaving the laboratory.
• Long hair should be tied behind the head to avoid contamination of specimen.
• General domestic waste should be disposed in a green container.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Urine may be disposed by pouring it into a laboratory sink.
• Sink should be disinfected using sodium hypochlorite daily.
• Never pipette anything by mouth.
• Containers and other equipment which contains specimen should be marked as
containing biohazard.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to chemicals like bag breakage and splash, should be
immediately recorded and reported to the concerned authorities and action
should be taken based on the laboratory guidelines.
• There should be an approved spill kits in the laboratory.
• Do not pour chemicals down the sink.
• Chemicals must be arranged based on its hazard capabilities.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature.
• Waste that contains chemicals must be disposed to yellow with black band
container.
• Report any broken equipment, especially those containing infectious materials.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.
• Adjust the position of microscope to your comfortable height.
Fecalysis
• Staff must behave in a safe and responsible manner.
• No eating, drinking or smoking in the laboratory.
• All staff working in the laboratory must wear protective equipment such as:
gloves, laboratory gown, mask and closed shoes.
• Laboratory coat should not be worn outside the laboratory.
• Hands must be washed before leaving the laboratory.
• Long hair should be tied behind the head to avoid contamination of specimen.
• General domestic waste should be disposed in a green container.

Biohazard
• Work surface should be decontaminated before and after routine work is done.
• Any contaminated reusable materials must be decontaminated before reuse.
• Infectious waste should be disposed in a yellow container.
• Do not put biohazardous fluids down the sink.
• Report any broken equipment, especially those containing infectious materials.
• Containers and other equipment which contains specimen should be marked as
containing biohazard.

Chemical
• Material Safety Data Sheet must be available in the laboratory.
• The laboratory must have Chemical Hygiene Plan.
• Staff must know the location and availability of reference materials on hazard,
handling, storage and disposal of hazardous chemicals.
• Accidental exposures to chemicals like bag breakage and splash, should be
immediately recorded and reported to the concerned authorities and action
should be taken based on the laboratory guidelines.
• There should be an approved spill kits in the laboratory.
• Do not pour chemicals down the sink.
• Chemicals must be arranged based on its hazard capabilities.
• Chemical reagent must be stored in a place away from activities where it can
accidentally be hit.
• Chemical reagent must be stored in its required temperature.
• Waste that contains chemicals must be disposed to yellow with black band
container.
• Report any broken equipment, especially those containing infectious materials.

Ergonomic
• Use ergonomically designed chair.
• Store heavy items on lower shelves.
• Keep frequently used items within reach.
• Use proper sitting posture and positioning.
• Take mini break to relieve the body after each task.
• Adjust the position of microscope to your comfortable height.

Chapter IX
Financial Management

LABORATORY UTILITIES RENDERING COSTS


 Cotton Balls ₱75.00
 5 CC (Terumo Syringe) ₱700.00
 3 CC (Terumo Syringe) ₱650.00
 10 CC (Terumo Syringe) ₱750.00
 1 CC (Terumo Syringe) ₱700.00
 Face Mask ₱90.00
 Disposable Gloves ₱290.00
 Sterile Gloves ₱650.00
 Needles ₱350.00
 Magnifying Glass ₱120.00

LABORATORY EQUIPMENTS RENDERING COSTS


 Electron Microscope ₱18,000.00
 Hemato-Centrifuge ₱34,000.00
 Chemical Resistant Laboratory ₱40,590.00
Fume Hood Lab Equipment
 Microbiology Lab Furniture C ₱9,200.00
Frame Bench with Wall Cabinet
 Lab Inteligent Gas Storage ₱9,200.00
Cupboard
 Class 100 Lab Bench Clean Room ₱9,200.00
 H-Frame Structure All Steel Lab ₱45,000.00
Island Bench
 Class III Biosafety Cabinet ₱75,000.00
 Chemistry Analyzer / Blood ₱255,000.00
Analysis
 Steam Autoclave / Sterilizer ₱60,000.00
 Semi-Auto Coagulation Analyzer ₱30,500.00
 Biobase Laboratory Analyzer ₱60,000.00
 Electrocautery equipment ₱46,000.00
 Non frost-free freezer with -20°C ₱500,000.00 - ₱750,000.00

LABORATORY ITEMS RENDERING COSTS

 Uncoagulated Tubes ₱550.00


 Coagulated Tubes ₱350.00

 Test Tubes ₱650.00

 Petri Dish (Glass) ₱120.00

 Stirring Rod ₱80.00

 Test Tube Rack ₱700.00

 Glass Slider ₱50.00


 Glass Stain Remover ₱700.00

 Glass Transfer Pipets ₱250.00

Histology Department

Biopsy – Small ₱650.00

Biopsy – Medium ₱950.00

Biopsy – Large ₱1,150.00

Biopsy - Extra large ₱1,350.00

Biopsy - Bone tissue (with decalcification) ₱750.00

Biopsy - Cervical punch ₱950.00

Biopsy - Frozen Section ₱4,150.00

Gram stain - Cervico-vaginal smear ₱300.00

Pap smear ₱300.00

Special stain tissue ₱650.00

Autopsy ₱4150.00

Cell Block ₱650

LABORATORY TESTS
Rates and Fees

Coagulation Department

Factor V Assay ₱1,000.00

Factor VIII Assay ₱1,000.00

Factor IX Assay ₱1,000.00

Fibrinogen level ₱300

Prothrombin time (PT or PT-INR) ₱550.00


APTT (Activated Partial Thromboplastin Time) ₱700.00

CT/BT - Clotting Time + Bleeding Time ₱80.00

D-Dimer ₱500.00

Platelet Aggregation ₱200.00

Microbiology Department

Culture and Sensitivity ₱970.00


Blood Culture without BACTEC vial ₱550.00

Blood Culture with BACTEC vial ₱700.00


Stool/ Rectal Swab Culture ₱800.00
Gram Staining ₱500.00
Acid Fast Staining ₱400.00
Giemsa Staining ₱300.00
KOH ₱290.00
Wet mount ₱300.00
India Ink ₱300.00

Clinical Chemistry Department

Albumin ₱220.00

₱240.00
Alkaline Phosphatase

₱235.00
ALT/SGPT

₱380.00
Amylase

₱235.00
AST/SGOT

₱250.00
Bilirubin (B1+B2)
₱250.00
BUN – Blood Urea Nitrogen

₱250.00
Calcium – Ca

₱250.00
Chloride – Cl

₱230.00
Cholesterol (Total)

₱230.00
Creatinine

₱500.00
CSF and Body Fluid (cell count & differential count only)

₱450.00
CSF and Body Fluid (Sugar & protein)

₱180.00
Glucose – FBS/RBS

₱300.00
Glucose – Post-prandial

₱290.00
Glucose – Oral Glucose Challenge

₱535.00
Glucose – OGTT x 3 takes

₱780.00
Glucose – OGTT x 5 takes

₱610.00
Hemoglobin A1c

₱320.00
LDH – Lactic dehydrogenase

₱620.00
Lipid profile (Cholesterol, HDL, LDL, Triglyceride)

₱290.00
Magnesium – Mg

₱210.00
Potassium – K+ only

₱210.00
Sodium – Na+ only
₱370.00
Sodium + Potassium (Na+ plus K+)

₱200.00
SUA – Serum Uric Acid

₱200.00
Total Protein

₱350.00
Total Protein + Albumin + AG ratio

₱290.00
Triglyceride

₱230.00
Urine – 24 hour – Albumin

₱225.00
Urine – Calcium

₱255.00
Urine - Chloride

₱240.00
Urine – 24 hour - Creatinine

₱240.00
Urine - Potassium

Immunology/Serology Department

₱900.00
Alpha Feto Protein

₱450.00
ASO (qualitative)

₱700.00
Beta-HcG (quantitative)

₱330.00
C-Reactive Protein (qualitative)

₱510.00
C3 (quantitative)
₱870.00
CA-125 (ovary)

CEA-- Carcino-embryonic antigen ₱820.00

Cortisol ₱750.00

Dengue Rapid Test ₱780.00

Ferritin ₱690.00

H-pylori ₱830.00

Hepatitis-Anti-HBs ₱600.00

Hepatitis-Anti-HCV ₱1,100.00

Hepatitis-Anti-HBc IgM ₱860.00

₱860.00
Hepatitis-Anti-HBc Total

₱700.00
Hepatitis-HAV IgG Total

₱700.00
Hepatitis-HAV IgM

₱330.00
Hepatitis - HbsAg (qualitative)

₱400.00
Hepatitis-HbsAg (quantitative)

₱650.00
HIV Ag (quantitative)

₱600.00
HIV Antibody

₱1000.00
PSA Total

₱450.00
RF – Rheumatoid Factor

₱250.00
RPD/VDRL – Syphilis

₱660.00
Thyroid – FT3
₱660.00
Thyroid – FT4

Thyroid – T3 ₱380.00

Thyroid –T4 ₱380.00

Thyroid – T3 + T4 ₱620.00

Thyroid – TSH ₱605.00

Troponin T (qualitative) ₱820.00

Troponin I (quantitative) ₱1300.00

Typhyidot ₱900.00

Hematology Department

₱400.00
APTT

₱100.00
Bleeding Time

₱300.00
Blood Typing (ABO plus Rh)

₱500.00
AMA Bone Marrow Smear

₱300.00
CBC (Complete Blood Count with Platelet Count)

₱100.00
Clotting Time (Lee-while Method)

₱200.00
Erythrocyte Sedimentation Rate

₱300.00
Peripheral Blood Smear

₱300.00
Prothrombin Time (with INR, PT% Activity)

₱100.00
RBC Count
₱100.00
Reticulocyte Count

₱280.00
Toxic Granules

₱300.00
WBC and Differential Count

Blood bank Department

₱200.00
Blood typing (ABO and Rh)

₱140.00
Blood typing (ABO only)

₱150.00
Blood typing (Rh only)

₱280.00
Coomb's Test (Direct)

₱450.00
Coomb's Test (Indirect)

₱460.00
Crossmatching (per bag) - Gel Technology

₱280.00
Platelet - Re-typing (per bag)

₱550.00
Fresh Frozen Plasma

₱260.00
DuVariant

₱1200.00
Whole blood

₱900.00
Pack red cells

₱500.00
Cryosupernate

₱345.00
Hepa-B
₱600.00
Hepa-C

₱200.00
Malaria:

₱395.00
HIV screen

₱400.00
Autologous Donation
INDIRECT AND UTILITY COSTS

Startup-funding Rendering cost


 Start-up Expenses to fund ₱250,000.00
 Start-up Assets to fund ₱8,250,000.00
Total Funding Required ₱8,500,000.00

Assets Rendering cost


 Assets ₱3,650,000.00
 Non-cash Assets from Start-up ₱4,600,000.00
 Cash Balance on Starting Date ₱4,600,000.00
Total Assets ₱12,850,000.00

Fixed Rendering cost


 Capital ₱50,000,000.00
 Electricity ₱20.5/kWh
 Water ₱35.48/cm^3
 Franchise Fee ₱600,000.00
Appendix I
References

Anon, Equipment and Supplies for Immunology: Clinical Laboratory: Diamedic Import.
Diamedic Import - Sitio Web Oficial - Página Principal. Available at:
https://diamedicimport.com/en/clinical-laboratory/immunology/ [Accessed November 27,
2019].

Anon, Immunological Laboratory Tests: List of High Impact Articles: PPts: Journals:
Videos. iMedPub LTD. Available at: http://www.imedpub.com/scholarly/immunological-
laboratory-tests-journals-articles-ppts-list.php [Accessed November 27, 2019].
Anon, PhPlate AB. Available at: http://www.phplate.se/?page_id=49#strep [Accessed
November 27, 2019].

Batty, I., 1976. Progress in standardization: 4 immunological reagents. Bulletin of the


World Health Organization. Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2366442/?page=3 [Accessed November
27, 2019].

Coombs & Kunkel, D., Immunology Laboratory Equipment - ppt download. SlidePlayer.
Available at: https://slideplayer.com/slide/10282436/ [Accessed November 27, 2019].

ClinLab Navigator. (n.d.). Quality Control. [online] Available at:


http://www.clinlabnavigator.com/quality-control.html [Accessed 2 Oct. 2019].

Lab Tests Blog. (2011). The Importance of Quality Control in Laboratory Testing.


[online] Available at: http://www.labtestsblog.com/quality-control-laboratory-testing/
[Accessed 2 Oct. 2019].

Laboratory Quality Management System. (2011). [ebook] Lyon, pp.72-98. Available at:
https://www.who.int/ihr/publications/lqms_en.pdf [Accessed 2 Oct. 2019].

Medical Laboratory Observer. (2019). Quality control in clinical laboratory samples.


[online] Available at: https://www.mlo-online.com/home/article/13007888/quality-control-
in-clinical-laboratory-samples [Accessed 3 Oct. 2019].

https://microbeonline.com/microbiology-laboratory-safety-rules-procedure/

http://www.d.umn.edu/~rhicks/genmicro/Microbiology%20Lab%20Safety.pdf

http://reprolineplus.org/system/files/resources/IPC_M8_BloodbanksLabs.pdf

https://www.who.int/bloodsafety/transfusion_services/BhutanNationalStandardsBTServices.pd
f

https://ehs.unc.edu/workplace-safety/ergonomics/lab/

https://protect.iu.edu/environmental-health/occupational-health/ergo-
program/lab/microscopy.html

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