UNIT 8: EQUIPMENT AND INVENTORY MANAGEMENT

XXI. QUANTIFICATION
XXII. FORMS AND LOGS
TRANS OUTLINE XXIII. RECEIPT OF SUPPLIES
XXIV. STORAGE OF SUPPLIES: GOOD PRACTICES
I. EQUIPMENT MANAGEMENT XXV. MONITORING INVENTORY
A. BENEFITS OF GOOD EQUIPMENT XXVI. INTERNAL QA: INSTRUMENTS AND
MANAGEMENT EQUIPMENT
B. EQUIPMENT MANAGEMENT: PROGRAM XXVII. TERMINOLOGIES
CONSIDERATIONS
II. SELECTING EQUIPMENT EQUIPMENT MANAGEMENT
A. CRITERIA TO CONSIDER ● Necessary to ensure accurate, reliable and
III. ACQUIRING EQUIPMENT timely testing.
A. THINGS TO CONSIDER
○ LEASE VS RENTALS
B. BEFORE PURCHASING ASK IF
IV. ACQUISITION OF NEW EQUIPMENT
JUSTIFICATIONS
A. PRIORITY OF NEEDS
V. INSTALLING EQUIPMENT
VI. GETTING EQUIPMENT READY FOR UE
VII. EQUIPMENT CALIBRATION
VIII. PERFORMANCE EVALUATION
A. VERIFICATION OF MANUFACTURER’S BENEFITS OF GOOD EQUIPMENT MANAGEMENT
PERFORMANCE CLAIMS
● Helps to maintain a high level of laboratory
IX. IMPLEMENTING AN EQUIPMENT MAINTENANCE
performance.
PROGRAM
A. MAINTENANCE PLAN ● Reduces variation in test results and improves
B. PREVENTIVE MAINTENANCE the technologist’s confidence in the accuracy
C. REPAIR of testing results.
D. CALIBRATION ● Lowers repair costs, as fewer repairs will be
X. PREVENTIVE MAINTENANCE needed for a well-maintained instrument
a. EQUIPMENT INVENTORY ○ Reduce downtime of the equipment ->>
XI. TROUBLESHOOTING THE EQUIPMENT reduce repair cost and you will be able to
XII. SERVICE AND REPAIR EQUIPMENT keep the instrument in their maximum
XIII. RETIRING AND DISPOSING EQUIPMENT capacity and will lengthen the lifespan of
XIV. EQUIPMENT MAINTENANCE the instrument.
DOCUMENTATION ○ Mean time before failure- how long will the
XV. PURCHASING AND SUPPLIES INVENTORY instrument work until it will show first
MANAGEMENT signs of disaster? If brand new it will last
XVI. PRODUCT RESEARCH AND PRODUCT for 6 to 7 months after this it will require
SPECIFICATION attention.
XVII. PURCHASING: SELECTING VENDORS ● Lengthens instrument life
XVIII. DOCUMENTS INVOLVED IN THE ● Reduces interruption of services due to
PURCHASING PROCESS breakdowns and failures.
XIX. CONSIDERATIONS IN SETTING UP
● Increases safety for workers
PURCHASING PROCEDURES
XX. IMPLEMENTING AN INVENTORY ● Produces greater customer satisfaction
MANAGEMENT PROGRAM
2H-MT | A.Y. 2022-2023 Page 1 of 9
 EQUIPMENT MANAGEMENT: PROGRAM ● Specific:
CONSIDERATIONS ○ The chances that the result is zero
● (Good program for) Selection and purchasing ○ If the result is positive, a negative result is
○ Put it in actual test low
● Installation ○ false negative is low
○ Do they have the right number of ○ All test that are positive will mostly likely
engineers? be a true positive
● Calibration and performance evaluation ● Sensitive:
○ Calibration: set up the instrument and ○ Lahat ng tatawagan mo negative ay
calibrate and create a calibration curve, it totoong negative
is created in order for the instrument to ○ False positive result is low
calculate all of the succeeding patients ○ It can detect even the lowest level of
eventually. The calibration is setup to give concentration of a particular analyte
you the quantitative results in units ● For HIV testing you don’t want a false negative, thus
○ Performance evaluation: A repetitive test important ang sensitivity.
(one sample is ran up to 10 times) to check ● Ayaw mo ng false negative is pag negative walang
if results consistent, to check accuracy and confirmatory.
precision the test is done repeatedly
● Maintenance ACQUIRING EQUIPMENT
● Troubleshooting THINGS TO CONSIDER
● Service and repair ● Is it better to purchase or lease equipment?
● Retiring and disposing of equipment ● Factor in repair costs
● Manufacturers should provide all the
SELECTING EQUIPMENT necessary information to operate and maintain
CRITERIA TO CONSIDER equipment.
● One of the most important functions as a medical ● Consider savings that could be negotiated if
technology (selecting equipment) the laboratory needs more than one piece of
● Why and how will the equipment be used? The equipment.
instrument should be matched against the LEASE VS RENTAL PLANS
service the laboratory provides.
● What are the performance characteristics of LEASE RENTAL PLANS
the instrument? Is it sufficiently ● Periodic ● Periodic
accurate and reproducible to suit the needs of payments are payments are
the testing to be done? made made
● What are the facility requirements, including ● Usually, 3-5 years ● Without
the requirements for physical ● Purchased or purchase option
space? leased for longer ● The equipment is
● Will the cost of the equipment be within the periods at returned
laboratory’s budget? reduced rate. ● Another rental is
● Will reagents be readily available? agreed, or it is
● Will reagents be provided free of charge for a metered.
limited period? If so, for how long?
● How easy will it be for staff to operate?
● Will instructions be available in a language
that is understood?
● Is there a retailer for the equipment in the
country, with available services?
● Does the equipment have a warranty?
● Are there any safety issues to consider?

2H-MT | A.Y. 2022-2023 Page 2 of 9

 BEFORE PURCHASING ASK IF:
● Wiring diagrams, computer software
information, a list of parts needed, and an
operator’s manual are provided.
● The manufacturer will install the equipment
and train staff (covering travel expenses as
necessary) as part of the purchase price.
● The warranty includes a trial period to verify
that the instrument performs as expected.
● The manufacturer’s maintenance can be
included in the contract and, if so, whether
maintenance is provided on a regular basis.
ACQUISITION OF NEW EQUIPMENT JUSTIFICATIONS
1. Replacement
○ Equipment can not be repaired or
excessive cost of repair results in
unacceptable delays
2. Increased workload
○ Volume increase justifies either
automation or additional personnel
3. Cost reduction
○ Reduction of operational expenses
state primarily in terms of personnel
and supplies
2. New and / or improved methodology
○ better patient care
PRIORITY OF NEEDS
1. Essential
● Needed immediately to maintain
quality patient care
2. Necessary
● As “essential” but greater leeway with
regard to time of acquisition
3. Desirable
● Means of reducing cost
4. Others
● Means of improving general working
condition
INSTALLING EQUIPMENT
● Verify that all physical requirements (electrical,
space, doors, ventilation and water supply)
have been met.
● Consider vendor’s responsibilities
installation should be confirmed in writing
prior to beginning the installation process.
2H-MT | A.Y. 2022-2023
● Checklist of the expected performance
specifications should be developed,
● so that performance can be quickly verified as
soon as the equipment is installed
GETTING EQUIPMENT READY FOR USE
● Assign responsibility for performing the
maintenance and operation programs.
● Develop a system for recording the use of parts
and supplies.
● Implement a written plan for calibration,
performance verification, and proper operation
of the equipment.
● Establish a scheduled maintenance program
that includes daily, weekly and monthly
maintenance tasks.
○ Scheduled maintenance programs should
be done after 3, 6, or 9 months from the
time of use. Program is continuous.
● Provide training for all operators; only
personnel who have been trained specifically
to properly use the equipment should be
authorized as operators.
○ Others can use it but they should have
proper training to prevent accidents or
mistakes.
EQUIPMENT CALIBRATION
● Follow the manufacturer’s directions carefully
when performing the initial calibration of the
instrument.
● Calibrate the instrument with each test run,
when first putting it into service.
○ Newly installed equipment must be
calibrated. Run a control to validate
calibration. Low, normal, and high
pathological controls must pass. All three
levels must pass.
● Determine how often the instrument will need
to be recalibrated, based on its stability and
the manufacturer’s recommendation.
○ Recalibration will be done because the
calibration may change depending on time
(after 1 or 2 weeks it changes).
● We calibrate because we want to convert the result
for of our running sample into a particular unit.
Page 3 of 9
 PERFORMANCE EVALUATION
● Prior to testing patient specimens, it is
important to evaluate the performance of new
equipment to ensure it is working correctly Includes:
with respect to accuracy and precision.
○ Precision- Get a sample and run it 20
times. Check the repeatability of the
results. Pag pasok yung coefficient
variation then you know your results are
reproducible and precise.
● Test methods using kits or laboratory
instruments need to be evaluated for the
ability to detect disease (sensitivity,
specificity, positive and negative predictive
value) and to determine normal and
reportable ranges.
○ Make sure you are using the test methods
and kits required by the manufacturers on
the instrument to prevent error.
● NB: This is one of the pressing issues that DOH is
regulating in relation to the COVID-19 crisis -
opening new molecular testing labs with new
equipment (or equipment not validated for
diagnostic use) and using unvalidated testing kits.
VERIFICATION OF MANUFACTURER'S PERFORMANCE
CLAIMS
● Manufacturers provide performance
evaluations for testing methods using their
kits or instruments, and include the
information in the package inserts or
operator’s manuals.
● However, laboratories need to verify the
manufacturer's performance claims, and
demonstrate they can get the same results
using the kits or equipment in their laboratory,
with their personnel.
Includes:
● Testing samples with known values and
comparing the results to the expected or
certified value
● If equipment is temperature controlled,
establishing the stability and uniformity of the
temperature
● NB: Validation can be carried out by running
samples in parallel using both old and new
equipment and methods for a period of time to
determine that the expected results can be
obtained.
2H-MT | A.Y. 2022-2023
IMPLEMENTING AN EQUIPMENT MAINTENANCE
PROGRAM
MAINTENANCE PLAN
● Preventive Maintenance
● Provision for Inventory
● Troubleshooting
● Repair of Equipment
PREVENTIVE MAINTENANCE
● Comes before a failure, while the equipment is
in operating condition.
REPAIR
● Applies to unscheduled maintenance
● Comes after the instrument has failed
CALIBRATION
● Assurance that the instrument measures
certain parameters within specified tolerance.
● Considered part of preventive maintenance
INITIAL STEPS IN IMPLEMENTING EQUIPMENT
MAINTENANCE PROGRAM
1. Assigning responsibility for providing
oversight
2. Developing written policies and procedures for
maintaining equipment, including routine
maintenance plans for each piece of
equipment that specify the frequency with
which all maintenance tasks should be
performed
3. Developing the format for records, creating
logs and forms, and establishing the processes
to maintain records
4. Training staff on the use and maintenance of
the equipment, and ensuring that all staff
understand their specific responsibilities
PREVENTIVE MAINTENANCE
● Includes measures such as systematic and
routine cleaning, adjustment and replacement
of equipment parts at scheduled intervals.
● Should be performed at regular intervals: daily,
weekly, monthly or yearly.
● Ensures that the equipment performs at
maximum efficiency and will increase the
lifespan of the equipment and help to prevent:
Page 4 of 9
 ○ Inaccurate test results due to
equipment failure
○ Delays in reporting results
○ Low productivity
○ Large repair costs
EQUIPMENT INVENTORY
● Laboratory should keep an inventory log of all
equipment in the laboratory.
● Log should be updated with information on
new equipment and include documentation of
when old equipment is retired.
FOR EACH PIECE OF EQUIPMENT, THE EQUIPMENT
INVENTORY LOG SHOULD HAVE A RECORD OF
1. Instrument type, make and model number, and
serial number so that any problems can be
discussed with the manufacturer
2. Date the equipment was purchased, and
whether it was purchased new, used or
reconditioned
3. Manufacturer/vendor contact information
4. Presence or absence of documentation, spare
parts and maintenance contract
5. Warranty’s expiration date
6. Specific inventory number indicating the year
of acquisition (this is especially useful for
larger laboratories)
TROUBLESHOOTING THE EQUIPMENT
NEEDED WHEN THE OPERATOR NOTICES CHANGES
SUCH AS:
● Drift in Quality Control or Calibrator Values
● Obvious Flaws in Equipment Function
● Equipment Fails to Operate
SOME OF THE QUESTIONS TO CONSIDER:
1. Is the problem related to a poor sample? Has
the sample been collected and stored properly?
Are factors such as turbidity or coagulation
affecting instrument performance?
2. Is there a problem with the reagents? Have
they been stored properly, and are they still in
date? Have new lot numbers been introduced
without updating instrument calibration?
3. Is there a problem with the water or electrical
supply?
4. Is there a problem with the equipment?
2H-MT | A.Y. 2022-2023
IF PROBLEMS CANNOT BE IDENTIFIED AND
CORRECTED IN-HOUSE, ATTEMPT TO FIND A WAY TO
CONTINUE TESTING UNTIL THE EQUIPMENT CAN BE
REPAIRED:
● Arrange to have access to backup instruments.
● Ask the manufacturer to provide a replacement
instrument during repairs.
● Send the samples to a nearby laboratory for
testing (must be in accordance to state
regulations such as DOH AO 2007-027 on the
referral of specimens).
NB: Do not use faulty equipment! Seek help from the
manufacturer or other technical expert. Place a note on the
equipment so all staff are aware that it is not in use.
SERVICE AND REPAIR EQUIPMENT
● May be provided by manufacturers from where
the equipment is purchased.
○ Set up a procedure for scheduling
service that must be periodically
performed by the manufacturer.
○ Some warranties require that repairs
be handled only by the manufacturer.
● Large facilities sometimes have biomedical
service technicians inhouse who perform
equipment maintenance and repair.
● Routine service should be scheduled so as not
to interrupt the flow of work.
RETIRING AND DISPOSING EQUIPMENT
● Occur when the instrument is:
○ Not functioning and not repairable
○ Outmoded and should be replaced with
new equipment
● Fully retired equipment should be disposed of
in an appropriate manner so that it will not
accumulate, take up valuable space and create
hazard
● When disposing of equipment:
○ Salvage any usable parts, particularly if
the equipment is being replaced with
another similar one.
○ Consider any potential biohazards and
follow all safety disposal procedures
■ e.g. biosafety cabinets must be
decontaminated first before
disposal
Page 5 of 9
 EQUIPMENT MAINTENANCE DOCUMENTATION
● Each major piece of equipment will have its
own equipment maintenance document.
● Smaller, commonly used equipment such as
centrifuges and pipettes may be managed with
an equipment maintenance document or
manual that deals with all such equipment in
the laboratory
AN EQUIPMENT MAINTENANCE DOCUMENT SHOULD
INCLUDE
● Step-by-step instructions for routine
maintenance, including frequency of
performance and how to keep records of
maintenance instructions for carrying out
function checks, frequency of performance,
and how to record the results
● Directions for calibrating the instrument
● Guide for troubleshooting
● Any required manufacturer’s service and repair
● List of any specific items needed for use and
maintenance, such as spare parts
PURCHASING AND SUPPLIES INVENTORY
MANAGEMENT
● “Uninterrupted availability of reagents, supplies and
services is needed for efficient and cost-effective
laboratory operations.”
I ● Define criteria for supplies or materials to be
BENEFITS
● Supplies and reagents are always available
when needed
● High-quality reagents are obtained at an
appropriate cost
● Reagents and supplies are not lost due to
improper storage, or kept and used beyond
expiration
KEY COMPONENTS
● Vendor/manufacturer qualifications
● Purchase agreements
● Receiving, inspecting, testing, storing, and
handling of materials
○ All purchased material should be
inspected and appropriately tested to
ensure that specifications are met, and
policies should be established for
storing and handling materials as they
are delivered to the laboratory
2H-MT | A.Y. 2022-2023
● Must allow for tracking materials to individual
patients
○ The laboratory should be able to
identify specific test materials used for
performing tests on any given day, so
that if there is a problem with a patient
result, the laboratory will know what
reagents were used
● Assessing and maintaining inventory
● Controlling expiration periods
● Dispatching supplies to satellite laboratories
PRODUCT RESEARCH AND PRODUCT
SPECIFICATION
● Product Research
○ Comparative Evaluation
○ By consultation with other users
○ By reference to publications offering
comparative studies of equipment and
supplies
● Product Specifications
○ Help assure adequate quality of
materials
○ Inventory control helps quality of
purchased after reagents and supplies
PURCHASING: SELECTING VENDORS
The Laboratory Should:
purchased
● Look for the best price, talking into account the
qualifications and credibility of the supplier
● Consider the advantages and disadvantages of
purchasing “brand name” compared to
“generic” products
○ (e.g. is it better to purchase specific
pipette tips for a specific pipette, or is
it just as effective to use generic
pipette tips that cost less?)
NB: It may be useful to seek information from other
laboratories when considering quality, reliability of supply
and cost.
EVALUATE VENDORS AFTER PURCHASE
Factors:
● Whether the vendor delivered the specified
goods
● Whether the central procurement body assured
that user specifications were met.
Page 6 of 9
 DOCUMENTS INVOLVED IN THE PURCHASING
PROCESS
1. Purchase requisition or order
● States the desired goods or services
with an estimate of the cost.
2. Packing slip
● Accompanies the shipped goods
3. Invoice
● Where payment is made
CONSIDERATIONS IN SETTING UP PURCHASING
PROCEDURES
● Understand any local or national government
requirements that need to be accommodated
in the contracts.
○ e.g. local FDA approval
● Negotiate for the best price without
undermining quality.
○ e.g. cheapest reagents but with the
highest sensitivity and specificity
value
● Carefully review all contracts to make sure the
laboratory’s requirements are being met.
○ Contracts should clearly address
payment mechanisms and provisions
to assure reliable availability and
delivery of reagents and supplies.
● Ask if there are penalties for ending a contract.
● Determine how payments will be made, and
how the vendor will assure reliable availability
and delivery of supplies and reagents.
IMPLEMENTING AN INVENTORY MANAGEMENT
PROGRAM
Steps for implementation:
● Assign responsibility-without this, nothing
may get done.
● Analyze the needs of the laboratory.
● Establish the minimum stock needed for an
appropriate time period.
● Develop needed forms and logs.
● Establish a system for receiving, inspecting
and storing supplies.
● Maintain an inventory system in all storage
areas and for all reagents and supplies used in
the laboratory.
2H-MT | A.Y. 2022-2023
QUANTIFICATION
● Very important process that can help calculate
how much is required of any particular item for
a given period of time
● Performed when making annual plans for the
laboratory and this planning will take into
account the usual usage of supplies and
reagents
● Accurate quantification will:
○ Ensure essential supplies will be
available when needed
○ Prevent overstocking, which can lead
to wastage of expensive materials.
QUANTIFICATION PROVIDES INFORMATION FOR:
● Estimating annual budget requirements
● Allowing for better planning
● Making decisions and monitoring performance
of the inventory management system
FORMS AND LOGS
Good tools for managing the stock include:
● Standardized forms
● Card systems
● Log books
For any system that is used, the following
information should be recorded:
● Date reagent or set of supplies are received
● Lot numbers for all supplies, reagents and kits
● Pass or fail acceptance criteria
● Date the lot number or box of supplies was put
into service or, if not usable, the date and
method of disposition
Additional information to record:
● Name and signature of the person receiving
the materials
● Date of receipt
● Expiration date
● Quantity of the material received
● Minimum stock that should be on hand
● Current stock balance
● Shelf number or name
● Destination
○ (e.g. to -20 deg C freezer to media
room)
Page 7 of 9
 RECEIPT OF SUPPLIES ● Assign the responsibility for this task to an
● All supplies and reagents should be inspected appropriate person or person-someone must
as they arrive in the laboratory to be sure that be in charge
they are in good condition and to verify that ● Be sure that all supplies and reagents in the
what is received is what was ordered. laboratory are covered by the system and
● Additional task for receiving personnel: maintain inventory management in all of the
○ Sign their name verifying receipt of storage areas
goods ● Conduct weekly physical counts of reagents
○ Date each item received and supplies in order to check the system, and
○ Note expiration date as a part of the monitoring process
○ Store new shipment behind existing ● Make sure that all records relevant to inventory
shipment management are updated and maintained
○ Create or update logbook records
INTERNAL QA: INSTRUMENTS AND EQUIPMENT
STORAGE OF SUPPLIES: GOOD PRACTICES
● Keep the storeroom clean, organized and
EQUIPMENT INDICATOR FOR FREQUENCY OF
locked to protect the inventory.
MONITORING QC TESTING
● Make sure storage areas are well ventilated
and protected from direct sunlight. INCUBATOR Temperature, Daily
● Ensure storage conditions are in accordance CO2
with the manufacturer’s instructions, paying
particular attention to any temperature ANAEROBE Anaerobiosis, Daily
requirements or other specifications, such as CHAMBER humidity and
safety requirements. temperature
● Use good shelving strong enough to support
items, and organize items carefully on the GASPAK JAR Anaerobiosis, Every use
shelves to prevent movement shifts or falls. catalyst-heated
○ Shelves should be attached firmly to
support walls to prevent tipping. AUTOCLAVE Temperature Each load
● Ensure items are accessible to staff. Spore testing Weekly
○ Sturdy step stools should be available
for reaching higher shelves and heavier MICROSCOPE Cleaned and Quarterly
items should be stored on lower adjusted
shelves; laboratory staff should not be
required to lift heavy items. CENTRIFUGE Check of *rpm Biannual
● When storing, put the new shipment behind
BIOHAZARD Air flow At least once a
existing materials that are already in the
HOOD year or
laboratory
everytime
○ Organize the reagents and materials so
hood/*BSC is
that the older materials get used first
transferred to
(i.e. items with the first expiry dates are
another
the first used).
location
MONITORING INVENTORY
ANALYTICAL Accuracy of At least once a
BALANCE weights year
“Procedures should be developed and put in place
for continuous monitoring of the inventory.” *BSC - Biological Safety Cabinet
Rpm - Revolution per minute
To ensure this done effectively:

2H-MT | A.Y. 2022-2023 Page 8 of 9

 TERMINOLOGIES Positive predictive value is the proportion of cases
giving positive test results who are already patients. It
Patient: positive for disease is the ratio of patients truly diagnosed as positive to all
those who had positive test results (including healthy
Healthy: negative for disease subjects who were incorrectly diagnosed as patient).
This characteristic can predict how likely it is for
True positive (TP) = the number of cases correctly someone to truly be patient, in case of a positive test
identified as patient result.

False positive (FP) = the number of cases incorrectly
identified as patient
True negative (TN) = the number of cases correctly
identified as healthy
False negative (FN) = the number of cases incorrectly
identified as healthy
Accuracy: The accuracy of a test is its ability to
differentiate the patient and healthy cases correctly. To
estimate the accuracy of a test, we should calculate
the proportion of true positive and true negative in all
evaluated cases.
Mathematically, this can be stated as:
𝑇𝑃+𝑇𝑁
Accuracy = 𝑇𝑃+𝑇𝑁+𝐹𝑃+𝐹𝑁
Positive predictive value =
𝑇𝑃
𝑇𝑃+𝐹𝑃
Negative predictive value is the proportion of the
cases giving negative test results who are already
healthy. It is the ratio of subjects truly diagnosed as
negative to all those who had negative test results
(including patients who were incorrectly diagnosed as
healthy). This characteristic can predict how likely it is
for someone to truly be healthy, in case of a negative
test result.
𝑇𝑁
Negative predictive value = 𝑇𝑁+𝐹𝑁
For examples and further explanation:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC460
8333/

Sensitivity: The sensitivity of a test is its ability to

determine the patient cases correctly. To estimate it,
we should calculate the proportion of true positive in
patient cases.

Mathematically, this can be stated as:

𝑇𝑃
Sensitivity = 𝑇𝑃+𝐹𝑁

Specificity: The specificity of a test is its ability to

determine the healthy cases correctly. To estimate it,
we should calculate the proportion of true negative in
healthy cases.

Mathematically, this can be stated as:

𝑇𝑁
Specificity = 𝑇𝑁+𝐹𝑃

2H-MT | A.Y. 2022-2023 Page 9 of 9

 UNIT 9: QUALITY MANAGEMENT
TRANS OUTLINE
I. LABORATORY QUALITY
A. NEGATIVE CONSEQUENCES OF
LABORATORY ERROR
II. QUALITY MANAGEMENT SYSTEM
III. INTERNAL QUALITY CONTROL
A. QUANTITATIVE EXAMINATION
B. QUALITATIVE EXAMINATION
C. SEMIQUANTITATIVE EXAMINATION
IV. ELEMENTS OF A QUALITY CONTROL
PROGRAM
V. STEPS IN IMPLEMENTING A QUALITY
CONTROL PROGRAM
VI. ELEMENTS OF A QUALITY CONTROL
PROGRAM
VII. STEPS IN IMPLEMENTING A QUALITY
CONTROL PROGRAM
VIII. LABORATORY PRACTICES ON ASSURING
QUALITY
A. CONTROL MATERIALS
IX.CONTROL MATERIALS VS.CALIBRATORS
A. CALIBRATORS
B. TYPES OF CONTROL MATERIALS
C. SOURCES OF CONTROL MATERIALS
D. CHOOSING THE CONTROL MATERIALS
X. ESTABLISHING THE VALUE RANGE FOR THE
CONTROL MATERIAL
A. OUTLIERS
B. QUALITY CONTROL CHART
XI. INTERPRETING QAULITY CONTROL DATA
A. SHIFTS
B. TRENDS
* These consequences result in increased cost in time and
C. CONTROL OF TESTS
personnel effort and often in poor patient outcomes.
D. CONTROL OF SPECIMEN
E. CONTROL OF REAGENTS AND SUPPLIES
F. CONTROL OF EQUIPMENT AND
INSTRUMENTS
G. CONTROL OF STAFF
XII. EXTERNAL QUALITY ASSESSMENT
PROGRAM (EQAP)
2H-MT | A.Y. 2022-2023
XIII. NATIONAL REFERENCE LABORATORIES
XIV. PROFICIENCY TESTING
XV. OTHER EXTERNAL QUALITY ASSESSMENT
METHODS
XVI. NON-ANALYTICAL CONTROL FUNCTIONS
A. LABORATORY PROTOCOLS
o Physician request
o Request specification
o Worksheets
o Patient Distribution
o Distribution of test results
o Specimen reassignments
(send-out/outscourcing)
B. FACTORS TO BE CONSIDERED IN THE
SELECTION OF REFERNECE OR
OUTSOURCES LABORATORIES
LABORATORY QUALITY
● Defined as accuracy, reliability, and timeliness
of reported test results.
● Final output or the result in the lab.
● If the reagent has a high absorbance reading
compared to what you should be getting, it may
mean na:
○ Nasira na yung reagent
○ Contaminated yung reagent
○ Marumi yung lab, machine, or yung
pinaglagyan ng machine, etc.
NEGATIVE CONSEQUENCES OF LABORATORY ERROR
● Unnecessary treatment
● Treatment complications
● Failure to provide the proper treatment
● Delay in correct diagnosis
● Additional and unnecessary diagnostic testing
Page 1 of 9
 QUALITY MANAGEMENT SYSTEM
● Coordinated activities to direct and control an
organization with regard to quality (ISO and
CLSI definition).
* A method of detecting errors at each phase of testing is
needed if quality is to be assured.
● Wrong sample collection will make everything
wrong, up to treatment.
● Everything in the pre-analytics will be linked to you,
the medical technologist.
● Everything in the analytics will be linked to the
machine.
● The capacity or method used in the clinical
laboratory to detect errors in each phase.
● A system; from the very beginning or the patient
themself down to the result which is released and
then interpreted by the clinician.
● Complexity of the laboratory system requires
that many factors must be addressed to
assure quality in the laboratory:
○ The laboratory environment
○ Quality control procedures
○ Communications
■ Coordinating with others
○ Record keeping
■ You will have to compare the
results you get now to past
records to see if there is a change
in the trend of the numbers you
are getting.
○ Competent and knowledgeable staff
■ Confidence (Knowledge, Ability,
Skill, Habit)
○ Good-quality reagents and equipment
2H-MT | A.Y. 2022-2023
INTERNAL QUALITY CONTROL
● Control being done inside the clinical laboratory.
● A set of procedures for continuously assessing
laboratory work and the emergent results
(WHO).
● May also refer to quality control
○ Focused on procedures
● Examining “control” materials of known
substances along with patient samples to
monitor the accuracy and precision of the
complete analytic process.
● Monitors activities related to the examination
(analytic) phase of testing.
○ Run a control on the robot/machine in
order to make sure it is giving you the
correct values.
● Goal: To detect, evaluate, and correct errors
due to test system failure, environmental
conditions or operator performance, before
patient results are reported.
Applied to monitor:
QUANTITATIVE EXAMINATIONS
● Measure the quantity of an analyte present in
the sample.
● Measurements need to be accurate and
precise.
● Measurement produces a numeric value as an
end-point, expressed in a particular unit of
measurement.
Example: Blood glucose = 5 mg/dL
Page 2 of 9
 QUALITATIVE EXAMINATIONS ● Establish a system for monitoring control
● Measure the presence or absence of a values
substance or evaluate cellular characteristics ● Take immediate action if needed
such as morphology. ● Maintain records of QC results and any
Examples: corrective actions taken
○ Microscopic examinations (positive or
negative, normal or abnormal) LABORATORY PRACTICES ON ASSURING QUALITY
○ Serologic procedures for presence or 1. Preventive
absence of antigens and antibodies ● Activities done prior to the
(reactive or nonreactive) examination of specimen or sample
○ Microbiological procedures (growth or and are intended to establish systems
no growth) conducive to accuracy in analytic
systems such as preventive
SEMIQUANTITATIVE EXAMINATIONS maintenance and calibration of
● Results are expressed as an estimate of how instruments, testing of media,
much of the measured substance is present. orientation and training of personnel.
● Expressed in terms such as “trace amount”, 2. Assessment
“moderate amount”, or “1+, 2+, or 3+”. ● Activities done during the testing to
Examples: determine whether the test systems
○ Urine dipsticks, tablet tests for ketones are performing correctly such as the
○ Serologic agglutination procedure use of standards and control
○ Serologic testing result expressed as a materials and maintenance of
titer (involves a number but provides control charts
an estimate, rather than an exact 3. Corrective
amount of the quantity present) ● Activities done when error or possible
error is detected to correct the system
ELEMENTS OF A QUALITY CONTROL PROGRAM such as equipment rouble shooting,
● Establishing written policies and procedures, recalibration of instruments, etc.
including corrective actions.
● Training all laboratory staff CONTROL MATERIALS
● Ensuring complete documentation ● Substances that contain an established
● Reviewing quality control data. amount of the substance being tested - the
● You can see that quality control is not just lip analyte
service since you have evidence and data through ● Tested at the same time and in the same way
complete documentation. as patient samples
● Purpose:
STEPS IN IMPLEMENTING A QUALITY CONTROL ○ to validate the reliability of the test
PROGRAM system
● Establish policies and procedures ○ to evaluate the operator’s performance
● Assign responsibility for monitoring and and environmental conditions that
reviewing might impact results
● Train all staff on how to properly follow policies
and procedures
● Select good QC material
● Establish control ranges for the selected
material
● Develop graphs to plot control values
(Level-Jennings charts)

2H-MT | A.Y. 2022-2023 Page 3 of 9

 CONTROL MATERIALS VS.CALIBRATORS

CALIBRATORS
● Also called standards
● Are solutions with a specified defined
concentration that are used to set or calibrate
an instrument, kit, or system before testing is
begun
● Should not be used as controls since they are
used to set the instrument
● Usually do no have the same consistency as
patients’ samples
ESTABLISHING THE VALUE RANGE FOR THE CONTROL
MATERIAL
TYPES OF CONTROL MATERIALS
● Determine the range of acceptable values for
1. Frozen
the control material to know if the test run is
2. Freeze-dried (lyophilized) - must be
“in control” or “out of control”
reconstituted, requiring great care in pipetting
● Done by assaying the control material
in order to ensure the correct concentration of
repeatedly over time
the analyte
● At least 20 data points must be collected over
3. Chemically preserved
a 20-30 day period
● Calculate the mean and standard deviation of
SOURCES OF CONTROL MATERIALS
the results
1. Purchased
● Assayed controls
○ Have a predetermined target
value, established by the
manufacturer
○ Laboratory must verify the
value using its own methods
○ More expensive to purchase
than unassayed controls
2. Obtained from a central or reference laboratory
3. Made in-house by pooling sera from different
patients

* when using either unassayed or “in-house” controls, the

laboratory must establish the target value of the analyte.

CHOOSING THE CONTROL MATERIALS

● Select values that cover medical decision
points - one with a normal value and one that
is either high or low, but in the medically
* purpose of obtaining 20 data points by running the QC
significant range
sample is to quantify normal variation and establish ranges
for QC samples

2H-MT | A.Y. 2022-2023 Page 4 of 9

 OUTLIERS
● One or two data points that appear to be too
high or too low for the set of data
● presence among the 20 data points indicate a
problem with the data
○ Data should not be included when
calculating QC ranges
○ Identify and resolve the problem and
repeat the data collection

QUALITY CONTROL CHART

The values on the chart are those run on days 1, 2, and 3 after
Level-Jennings Chart
the chart was made. In this case, the second value is “out of
● Commonly used to represent the control range
control” because it falls outside of 2 SD.
graphically for the purpose of daily monitoring
● Shows the mean value as well as +/- 1, 2, and 3
SHIFTS
SD
● Occur when an abrupt change is followed by
● Mean - shown by drawing a line horizontally in
six or more consecutive QC results that fall on
the middle of the graph
one side of the mean, but typically within 95%
● SD - marked off at appropriate intervals and
range as if clustered around a new mean
lines drawn horizontally on the graph
● Results are rejected

TRENDS
● Occur when values gradually, but continually,
move in one direction overs six or more
analytical runs
● May display values across the mean, or they
may occur only on one side of the mean
● Results are rejected

CONTROL OF TESTS
Selection of tests should be based on four factors:
1. The Result
INTERPRETING QUALITY CONTROL DATA ● The result produced should be useful
● Run the control and plot it on the in a time-reference frame
Levey-Jennings chart 2. The Procedure
● If the value is within +2 SD, the run can be ● The procedure should be feasible for
accepted as “in control” the particular laboratory
● Employ Westgard Rules for a more 3. The Value
comprehensive decision making ● The value produced should be accepted
to clinicians
4. The Reports
● The reports forwarded to clinicians
should be uniform
● A good report should be compact and
consistent in terminology and format

2H-MT | A.Y. 2022-2023 Page 5 of 9

The assessment factors for method evaluation and
selection:
1. Precision
● Maybe defined as the extent to which
measurements are repeated
● Assessment is made by replicate
analysis of a biological control
containing stable and measurable
amounts of the appropriate
constituent(s) and expressed as the
magnitude of error in the method
2. Accuracy
● Maybe defined as the extent to which
measurement approach the “true:
quantity of the constituent being
analyzed
● Measurement must be conducted on a
reference material having a known
composition and concentration
3. Sensitivity
● Maybe defined as either:
○ The extent to which the
minimum amount of
constituent can be measured
of
○ The reliability of a test to be
positive in the presence of the
disease it was designed to
detect
4. Specificity
● Maybe defined as either:
○ The extent to which
measurements are those of
single constituent
○ The reliability of a test to be
negative in the absence of a
disease it was designed to
detect
CONTROL OF SPECIMEN
● Collection of proper specimen is extremely
important
● Those involved in specimen collection must
know the following:
○ Proper way to collect a specimen
○ Correct details concerning name of
tests
○ Preparation of patients
2H-MT | A.Y. 2022-2023
○ Containers and labels
○ Preservative or anticoagulant
○ Handling or storage of specimen before
delivery to lab
○ Special instructions and other special
specimen requirements
● A good way to assure proper specimen is the
distribution of specimen collection manual to
those involved in collection.
CONTROL OF REAGENTS AND SUPPLIES
● Guidelines in the use of reagent kits:
○ It should give consistent results form
day to day and in patient samples with
low, normal and elevated values
○ Manufacturer’s data must be
complete: statement of principle,
description or test performance and
calculation, data on precision,
accuracy and stability of reagents
○ Cheaper than manual methods
○ Every employee should be competent
to use the kit.
● Reliability of reagents
○ Check for contamination or
deterioration
○ Frequent assessment of reagents’
quality
○ May employ a one-step method
involving running of QC materials (e.g.
Clinical Chemistry and Hematology)
CONTROL OF EQUIPMENT AND INSTRUMENTS
● Suggestion in the control of equipment
○ Use National Bureau of Standards
guidelines for monitoring water baths,
heating blocks etc.
○ Verify reliability of analytical balances
and weights
○ Check speed of centrifuge using a
tachometer
○ Check all water used in testing for its
pH, purity and any foreign substance
○ Perform method validation for new
analyzers/equipment or as deemed
necessary for the old ones
Page 6 of 9
 CONTROL OF STAFF
● Maintain an atmosphere of professional
challenge
● Offer fair wages
● Provide a means for obtaining continuing
professional education and career
advancement
NOTE: To be sure the staff is working at maximum efficiency,
do not underutilize or overwork. A system of workload
reporting is necessary.
EXTERNAL QUALITY ASSESSMENT PROGRAM (EQAP)
● Program where participating laboratories are
given unknown samples for analysis
● Samples are to be treated as ordinary human
specimens for the usual processing and
examination
● Administered by the different National
Reference Laboratories (NRL) - almost all NRLs
send one set of samples per year
● Certificate of participation is required for
renewal of the laboratory’s license from the
DOH-HFSRB
EAST AVENUE MEDICAL CENTER (EAMC)
● NRL for Environmental, Occupational Health,
Toxicology and Micronutrient Assay
TRANSFUSION TRANSMISSIBLE INFECTIONS -NRL
(TTI-NRL)
● NRL for Hepatitis B Virus, Hepatitis C Virus,
Human Immunodeficiency Virus 1&2, Syphilis
and Malaria among blood banks and blood
service facilities.
Quality of performance of the participating labs
is assessed through:
1. Closeness of results to the predetermined
value/results.
a. Example: Results for bacterial
identification of NRL-RITM NEQAS
sample

NOTE: EQAP is stipulated in DOH AO 2007-0027 (Revised 2. Reference value generated by the participating
Rules and Regulations Governing the Licensure and laboratories through peer group analysis.
Regulation of Clinical Laboratories in the Philippines) a. Total cholesterol result of a NEQAS
sample form NRL-LCP
NATIONAL REFERENCE LABORATORIES
● Routinely send samples, evaluate results, and
issue certificate of participation to
participating labs:

LUNG CENTER OF THE PHILIPPINES (LCP)

● NRL for Clinical Chemistry

NATIONAL KIDNEY AND TRANSPLANT INSTITUTE

● NRL for Hematology

SAN LAZARO HOSPITAL/ STD AIDS COOPERATIVE

CENTRAL LABORATORY (SLH/SACCL)
● NRL for HIV/AIDS and other Sexually
Transmitted Infections

RESEARCH INSTITUTE FOR TROPICAL MEDICINE

(RITM) NOTE: Peer group - laboratories with the same principle of
● NRL for Parasitology, Bacteriology, and testing and same brand of analyzer and reagents used in
Mycobacteriology testing.
2H-MT | A.Y. 2022-2023 Page 7 of 9
 PROFICIENCY TESTING
● The same as the National External Quality
Assessment Scheme (NEQAS) in the
Philippines, however, the term NEQAS is more
widely used.
● A program in which multiple samples are
periodically sent to members of a group of
laboratories for analysis and/or identification;
whereby each laboratory’s results are
compared with those of other laboratories in
the group and/or with an assigned value, and
reported to the participating laboratories and
others (CLSI definition).
● Optimal frequency will be 3-4 times yearly
● Widely used in countries that strictly follow
CLIA regulations
● May be administered by third party providers.
OTHER EXTERNAL QUALITY ASSESSMENT METHODS
● Rechecking or retesting
○ Slides that have been read are
rechecked by a reference laboratory.
○ Samples that have been analyzed are
retested, allowing for interlaboratory
comparison.
● On-site evaluation
○ External evaluation of quality on-site
and can be conducted in conjunction
with PT or rechecking/retesting.
○ Usually done when it is difficult to
conduct traditional proficiency testing
or to use the rechecking/retesting
method.
NON-ANALYTICAL QUALITY CONTROL FUNCTIONS
LABORATORY PROTOCOL
● A predefined written procedural method in the
design and implementation of laboratory
procedures.
2H-MT | A.Y. 2022-2023
● Provides individual sets of instructions that
allow scientists to recreate laboratory
procedures that include requisitioning,
reporting, assays, statistical methods,
reporting and troubleshooting standards.
PHYSICIAN REQUEST
● All requests made by the attending physician
should be stated clearly.
REQUEST SPECIFICATION
● Time Specification
○ Routine - response for test requests
within 24 hours or as specified in the
lab protocol, but many take longer for
some procedures as culture
○ Today - response and test results
within 8 hours
○ Stat - response within 10 mins or as
specified in the lab protocol, no delay
in test performance
○ Specific time - specimen collection
within +/-5 min time designated, no
delay in test performance
● Condition Specifications
○ Pre-op, post-op, pre-HD,
pre-admissions, etc.
● Patient Category Specifications
○ In-patient, out-patient, etc.
WORKSHEETS
● Are used most commonly for recording test
results and other informative data not usually
reported.
● Are particularly well suited to most hospital
Microbiology, Chemistry and Hematology
laboratories.
PATIENT IDENTIFICATION
● The customary practice is to attach
identification band to all patients.
● The exact matching of all patient information
appearing on the request with that on the
bracelet should be done.
● Ask for at least two unique identifiers before
doing specimen collection such as in
phlebotomy.
Page 8 of 9
 DISTRIBUTION OF TEST RESULTS
● Nursing station personnel (patient chart
attachment).
● Hospital business office (patient bills)
● Attending physician.
● Laboratory clerical section (department
records).

SPECIMEN REASSIGNMENTS (SEND-OUT/OUTSOURCING)

● Reassigning specimens to a reference or
outsourced laboratory is considered only after
the capabilities and cost of in-house
performance are determined.
● Usually done for special tests and in cases of
equipment downtime.

FACTORS TO BE CONSIDERED IN THE SELECTION OF

REFERENCE OR OUTSOURCED LABORATORIES
a. Range of available services
b. Quality (staff, facilities, etc.)
c. Location
d. Turn-around-time
e. Fee schedule (comparison with laboratories of
comparable structure)

NOTE: Sending-out of samples is regulated by DOH under

DOH AO 2007-0027 (Revised Rules and Regulations
Governing the Licensure and Regulations of Clinical
Laboratories in the Philippines)

2H-MT | A.Y. 2022-2023 Page 9 of 9

 UNIT 10: SAFETY MANAGEMENT
LABORATORY SAFETY PROGRAM
1. Plans for preventing sickness and injury to
TRANS OUTLINE personnel
2. Plans to prevent damage or destruction of
physical assets
I. SAFETY PROGRAM
II. LABORATORY SAFETY PROGRAM
OBJECTIVES
III. EMPLOYEE HEALTH PROGRAM 1. Safety skills and attitude of all personnel
IV. GENERAL SAFETY PROGRAM 2. Surveillance program for promptly identifying
V. SAFETY CODES hazards
VI. HAZARDS IN THE LABORATORY ○ Helps us monitor through NRLs
VII. CHEMICAL HAZARDS 3. Plans for promptly correcting all hazards
a. Program for Handling Chemicals 4. Laboratory safety efforts with overall hospital
VIII. BIOLOGICAL HAZARDS safety program
a. Personal Protective Equipment
EMPLOYEE HEALTH PROGRAM
b. Personal Protective Equipment
1. Pre-employment physical examination
and Materials
2. Periodic inspection of the above in most
c. Program for Handling Biological instances reassessments are made yearly
Materials 3. Written reports of all work-related illnesses
IX. MECHANICAL OR PHYSICAL HAZARDS and accidents
a. Safety Equipment in the 4. Employee health records for the total period of
Laboratory employment
b. Instructions for Proper Disposal of
Sharps GENERAL SAFETY PROGRAM
1. Orientation of New Employees
X. FIRE AND ELECTRICAL
2. Periodic supervisory staff meetings for the
a. Fire Prevention Program
purpose of discussing safety
XI. RADIATION HAZARDS
3. Orderly housekeeping standards for both
XII. LABORATORY LIABILITIES laboratory and housekeeping personnel
XIII. INJURY LIABILITIES OF THE 4. Sign indicating need for special precaution in
LABORATORY area
XIV. PROBLEM SOLVING 5. Orderly storage and arrangement of supplies
a. The Problem and working materials
b. Categories of a Problem 6. Policies governing eating, drinking, smoking,
XV. HOW TO APPROACH THE PROBLEM and safe attire within the department
a. Participative Problem Solving 7. Periodic inspections by the director or
designee for purposes of indicating interest
b. Unilateral Problem Solving
and concern
c. Seven Steps of Problem Solving
8. Consideration of periodic programs by outside
persons with expertise in special areas of
SAFETY PROGRAM
laboratory safety
● Secondary effects of a laboratory accident are:
9. Consideration of hiring a full or part-time
○ loss of reputation (no more trust) safety officer
○ loss of customers 10. Coordinated efforts with hospital for assuring
○ loss of income isolation of communicable diseases, control of
● Have a Written Procedure and Policy

2H-MT | A.Y. 2022-2023 Page 1 of 7

 nosocomial infections, and plans for dealing THREE MAIN ROUTES BY WHICH CHEMICALS ENTER
with fire and disaster THE BODY

SAFETY CODES 1. Inhalation - this is the major route of entry

1. Use proper techniques when working with solvent
2. Use safety devices and protective clothing 2. Absorption through skin - this may produce
wherever necessary systemic poisoning
3. Do not smoke, eat, drink, bite nails, or pencils, a. (Ex: organic lead, solvents such as
or apply cosmetics in the laboratory xylene and methylene chloride,
4. Assume that every chemical and biological organophosphate, pesticides, and
material is dangerous unless there is definite cyanides)
information to the contrary 3. Ingestion - accidental ingestion due to poor
5. Do not pipet with mouth hygiene practices
6. Fooling around should never be permitted in
the laboratory PROGRAM FOR HANDLING CHEMICALS
7. Hands should be washed as often as needed 1. Prescribed containers and adequate storage
8. Be tidy, clean up spillage immediately space
9. keep hands dry to avoid shocks from contact 2. Permanent container labels with clear
with faculty electrical switches, plugs, and identification of contents
writing 3. Policies for transporting containers
10. Turn off burners when not in immediate use 4. Instruction for dispensing, transferring, and
11. Do not work alone in the laboratory, a second disposing of all chemicals
person should be within call
BIOLOGICAL HAZARDS
HAZARDS IN THE LABORATORY “Treat all body fluids infectious”
1. Chemical Hazards - reagents
2. Biological Hazards - body fluids PERSONAL PROTECTIVE EQUIPMENT
3. Physical or Mechanical Hazards - ergonomic, ● The major routes by which laboratory staff
slippery floor, noise acquire work-related infections are:
4. Fire Hazards - flammable reagents 1. Percutaneous inoculation
5. Radiation Hazards - radioactive chemicals 2. Contact between mucous membranes
(thyroid hormones) and contaminated material
6. Electrical Hazards 3. Accidental Ingestion
7. Thermal Hazards - produces negative temp or ● When surfaces are contaminated by
heat biological spills, the appropriate actions to
8. Explosions and Implosions Hazards take care:
9. Noise Hazards ● Define/ isolate the contaminated area
10. Cryogenic Hazards - related to negative temp ● Alert coworkers
● Put on appropriate PPE
CHEMICAL HAZARDS ● Remove glass/lumps with forceps or
scoop
TWO TYPES OF CHEMICAL HAZARDS ● Apply absorbent towel(s) to the spill;
● External: remove bulk and reapply if needed
○ result of caustic or corrosive ● Apply a disinfectant to towel surface
substance ● Allow adequate contact time (20
● Internal: minutes)
○ results of the toxicity of substance ● Remove towel, mop up, and clean the
surface with alcohol or soap and water
● Properly dispose of materials
2H-MT | A.Y. 2022-2023 Page 2 of 7
 ● Notify the supervisor, safety officer, ○ Be aware of the composition
and other appropriate authorities. of fabrics, as some might be
highly flammable.
● If laboratory personnel becomes
contaminated with biological hazards due to PERSONAL PROTECTIVE EQUIPMENT
splashes or spills, immediate steps take AND MATERIALS
include: 1. Clothing
● Clean exposed skin or body surface 2. Gloves
with soap and water, eyewash (for eye a. Rubber Gloves (Hazardous Liquids)
exposure) or saline (for mouth b. Lead Gloves (Radioactive Materials)
exposures). c. Surgical Gloves (Pathogens)
● Apply supervisor, safety officer, or d. Insulated Gloves (Hot and Cold
security desk. Objects)
● Follow appropriate reporting e. Heavy Leather Gloves (Certain Animals)
procedures. 3. Safety Shoes
● Report to physician for treatment or 4. Hard Helmet
counselling. 5. Safety Eye Glasses
➢ Gloves 6. Respirators
Effective use of gloves relies on two a. Boron, Dry Flouride, Dimethyl Amino,
simple practices. Ethylene Oxide, Hydrogen Bromide
1. Remove gloves when leaving 7. Face Masks
the working area to prevent
contamination of other areas PROGRAM FOR HANDLING BIOLOGICAL
2. Never reuse gloves. MATERIALS
After use, gloves must be 1. Instruction for collecting, transferring, storing
disposed of in the and disposing of all specimens.
contaminated waste. 2. Policies for isolating test procedures
➢ Goggles 3. Instructions for washing and the care and
○ Protect eyes and other mucous cleaning of work surfaces.
membranes from projection by 4. Instructions for cleaning and / or disposing
using face shield of specimen
○ Contact lenses do not offer
protection from splashes. MECHANICAL OR PHYSICAL HAZARDS
Additional eye protection must ● Laboratory equipment is a significant source of
be worn with contact lenses. potential injury to laboratory staff, thus
➢ Masks making training in specific safety procedures
○ Reduce laboratory workers’ imperative.
respiratory exposure to ○ Ex. autoclaves, centrifuges,
airborne highly dangerous compressed gas cylinders and fume
pathogens hoods.
○ Use fit-tested particulate ○ Safety training and precautions are
respirators with adequate important
filtering during specimen
collection or handling SAFETY EQUIPMENT IN THE LABORATORY
■ e.g. EU FFP2, US 1. Fire Extinguisher - These are of three general
NIOSH-Certified N95 types
➢ Laboratory Coats a. Water Type
○ Compulsory in all instances b. Dry Chemical Type
c. Carbon Dioxide Type
2H-MT | A.Y. 2022-2023 Page 3 of 7
 2. Safety Showers 4. Well-conceived and rehearsal plans in event of
3. Eye Washes fire that are closely coordinated with hospital
4. Safety Shields efforts.

INSTRUCTIONS FOR PROPER DISPOSAL RADIATION HAZARDS

OF SHARPS ARE
● Avoid needle recapping.
● Put sharps in a puncture-resistant, leak-proof
sharps container.
● Label the container “Sharps”
● NEVER USE BOXES for disposal of:
○ Sharps
○ Biohazardous materials that have not
been autoclaved
○ Liquid wastes
○ Chemically contaminated laboratory
glassware or plasticware
○ Chemical containers that cannot be
disposed of as regular solid waste.
FIRE & ELECTRICAL
● Keep in mind that liquids with low flash points
may ignite if there are near heat sources such
as hotplates, steam lines or equipment that
might produce a spark or heat.
○ A small laboratory fire is considered to
be one that is extinguishable within 1-2
minutes.
○ Take it to cover the fire with an inverted
beaker or wet paper towels. If this fails,
use a fire extinguisher.
○ For large fires, call the appropriate local
authorities.
● Fire Hazards - Fires can be divided into four
important classes designated as classes A, B,
C, and D
a. Class A Fire
b. Class B Fire
c. Class C Fire
d. Class D Fire
FIRE PREVENTION PROGRAM
1. Physical facilities and operational practices
that satisfy fire code.
2. Instructions for handling and storing
combustibles; container labels with “flash
points”.
3. Instructions for operating all heat-generating
equipment.
2H-MT | A.Y. 2022-2023
● Source of radiation in the laboratory:
a. Radioactive isotopes
b. X-Rays
c. Ultraviolet Sources
● Radiochemicals require special precautions,
and dedicated benches with specific bench
covers for manipulation of readilabeled
elements are needed.
○ Appropriate protection (PlexiglasTM,
Lead)
○ Specific waste containers, depending
on the chemical nature of waste and
radioactive elements.
LABORATORY LIABILITIES
● Ensuring quality and safety during laboratory
processes is a major concern for laboratory
managers.
● As a laboratory director, it is important to:
○ Design and plan laboratory facilities
○ Assess all potential risks and apply
basic concepts of organization
○ Consider the organization of the
laboratory when developing new
activities or new diagnostic techniques
in the laboratory.
● As a Quality Manager (or designated safety
officer), it is necessary to:
○ Develop basic safety rules and
organization, and ensure that
personnel are trained in their specific
duties.
○ Know the basics of safety and
biosafety management issues
○ Know how to perform an extensive risk
assessment when developing new
activities in the laboratory;
○ Conduct laboratory safety audits.
● As a laboratorian, it is important to:
○ Be aware of basic safety rules and
processes;
○ Understand the basics of safety and
biosafety management issue:
■ with toxic chemicals
■ biological samples
Page 4 of 7
 ■ physical hazards
■ interacting with patients
INJURY LIABILITIES OF THE LABORATORY
● Laboratory equipment
● Storage of compressed gasses
● Needles and sharps
● Exposure to toxic chemicals and radioactive
materials pose a real threat to the health and
safety of laboratory staff.
● Laboratory acquired infections
● Aerosols contamination
● The major routes by which laboratory staff
acquire work-related infections are:
○ percutaneous inoculation
○ contact between mucous membranes
and contaminated material
○ accidental ingestion.
● Biological and chemical spills
● Laboratory fires
PROBLEM SOLVING
THE PROBLEM
● Defined as a deviation or an imbalance
between what “should be” and what “actually
is” happening.
○ Safety issues could come in if there is no
balance in what should be and what is
actually happening
● Change of one kind or another.
● Answered by the question, “what is wrong that
needs correction”.
CATEGORIES OF A PROBLEM
1. CAUSALITY OF A PROBLEM
● Well defined boundaries
● Elements are connected primarily
through cause and effect.
● Linear relationship
● Has a cause and effect
● There is an independent variable and
dependent variable
For example:
● The laboratory intercom’s failure to
work properly (Effect: Thus there is a
breakdown in communication)
2H-MT | A.Y. 2022-2023
● Boundaries are well-defined
● These elements are linked by cause
and effect.
2. MEANING-BASED PROBLEMS
● Boundaries are poorly defined.
● Rarely are linked directly by cause and
effect
● The nature of their connections
depends on the meaning attached to
each elements.
● Not easy to answer or solve because it
requires one to launch out research ex.
survey or focus group discussion.
For example:
● The financial proceeds of the
laboratory is declining
● Which elements are in and which are
not?
● The facilities, the personnel, the scope
of activity, the trend
● The elements to include are not given,
they must be chosen.
HOW TO APPROACH THE PROBLEM
PARTICIPATIVE PROBLEM SOLVING
● Employers allow or encourage employees to
share or participate in organizational
decision-making.
● Make a decision as a group by involving everyone.
UNILATERAL PROBLEM SOLVING:
● A manager may choose to make the decision
alone or request input from an individual with
specific expertise or experience in the subject
matter
SEVEN STEPS OF PROBLEM SOLVING
1. FIND THE PROBLEM
● Source for finding problem ;
○ Failure to meet objectives
○ Decreased production or
quality of service
○ Lowered employee morale
Page 5 of 7
 ○ Diminishing income
○ Rise in incident reports 4. EVALUATE ALTERNATIVE SOLUTIONS
○ Employees, peers and
supervisors ● Direct look at the pros and cons
○ Problem must be clear ● Cost-benefit analysis may be appropriate
○ Identify the problem ○ Financial aspect should be quantified
○ Make use of facts and not ○ The patient benefits verified
opinions
5. SELECT THE BEST SOLUTION
● A manager need only be alert to the existence
of problems and prepared to investigate their ● Select the best solution — the decision point
causes. ● Careful consideration must be given as to how
● Based on fact, and not the result of opinion, the decision is to be made.
misinterpretation, or bias
FOUR MAJOR TYPES OF DECISIONS
2. DIAGNOSE THE PROBLEM
1. Considered decision ● Have a major effect
● To assure a good diagnosis you should: on the total
a. Define the problem in writing operation
as briefly and accurately as ● Complicated and
possible require
b. Gather as much data as considerable
possible to determine the reflection
cause/s ● Require much
c. Identify the specific cause to interaction with
reduce work latter on others
d. Identify known constraints and
barriers that would preclude 2. Operational ● The routine kinds
some solutions decisions of things we do on
e. Bakit nangyari yung problema day to day basis
f. Hindi lang isa ang pag solve ng ● An excellent
problema, one should be open to opportunity to
many options to find a solution develop as
*When gathering information, it is important to work with decision makers
facts, not opinions.
3. Swallow hard ● The kind that are
3. DEVELOP ALTERNATIVE SOLUTIONS decisions often personally
uncomfortable
● Brainstorming approach ● Usually deal with
○ To develop a list of possible interpersonal
solutions relationships
○ As many solutions as possible ● Employees may not
should be identified like the decision
○ But none of them should be but they can
evaluated understand why it
○ Criticizing the suggestions was made.
○ To inhibit contributions, one of
which could possibly be the
basis of the best solution.
2H-MT | A.Y. 2022-2023 Page 6 of 7
 4. Ten-second ● Dictated by
decisions external pressure
● An employee
requesting an hour
off that day
● Primarily unilateral
decisions
● Managers must
remember that he
will be held
accountable for the
decision.

6. IMPLEMENT THE SOLUTION AFTER

DEVELOPING A PLAN

● ​Plan must be developed

● Designation of required personnel
● List of available financial
● Material resources
● Assignment of authority, responsibility and
accountability
● Gaining employee acceptance

7. EVALUATE FEEDBACK AND TAKE CORRECTIVE

ACTION WHERE NEEDED TO ENSURE THE
PROBLEM IS SOLVED

● Take corrective action

● Priorities are adjusted
● Situations require new action plans
● The manager’s responsibility to stay on the top
of the situation
● Either through periodic progress reports or
personal follow- up.

2H-MT | A.Y. 2022-2023 Page 7 of 7

 UNIT 11: FINANCIAL MANAGEMENT
FINANCIAL MANAGEMENT
● Planning the procurement
TRANS OUTLINE ○ Do not under purchase / over purchase.
● Utilization of funds
○ “Live within your means.”
I. FINANCIAL MANAGEMENT
● Controlling the financial operation to assure
A. FINANCIAL PLANNING
effective utilization of funds.
II. BUDGET
○ As students, allowance ang minamanage
III. LABORATORY BUDGETING natin na funds.
IV. HOW TO PREPARE BUDGETS? ○ If you have enough funds, ibabalik mo pa
A. BUDGET yan into the operation or ii-invest mo.
B. INCOME / REVENUE ● Effective management of a laboratory includes
C. EXPENSES / COSTS financial management. How and how much do you
○ Overhead Costs get paid for your services? Do you really know how
○ Personnel Costs much it costs to perform your testing? A clear
understanding of both sides of the balance sheet is
○ Supplies
necessary to effectively budget and manage the
V. CHART OF ACCOUNTS
finances of the laboratory.
VI. FINANCIAL ACCOUNTING STATEMENTS
● “Funds” is often used to denote money or cash.
A. BALANCE SHEET
B. INCOME STATEMENT FINANCIAL PLANNING
C. STATEMENT OF CASH FLOW ● Under financial management.
VII. TOOLS FOR FISCAL DECISION MAKING ● Setting of financial goals.
VIII. LABORATORY WORKLOAD REPORTING
IX.COMPONENTS OF WORKLOAD Example:
A. BASIC CALCULATION FOR DIRECT Goal: Save 10k in one-month
EFFORT CHOLESTEROL TEST
○ Productivity Units
Charge (Revenue) Php 200
X. DEPRECIATION
XI.PAYBACK PERIOD Cost Php 160
XII. COST FINDING
A. DIRECT COSTS Gross Income (Charge - Cost) Php 40
B. INDIRECT COSTS Tax of Gross Income (30%) Php 12
○ Fixed Costs
○ Variable Costs Net Income (Gross Income - Tax) Php 28
XIII. COST-REVENUE ANALYSIS
A. COST PER TEST
B. REVENUE PER TEST TOTAL TESTS NEEDED TO ACHIEVE 357 tests
C. PROFIT PER TEST THE GOAL
D. BREAKEVEN ANALYSIS (TEST VOLUME) ● The determination of future financial
E. BREAKEVEN ANALYSIS (REVENUE) requirements.
● Possible sources of funds.
● It is concerned with the setting of financial goals,
the determination of future financial requirements,
and the possible sources of funds which should be

2H-MT | A.Y. 2022-2023 Page 1 of 7

 available at the least cost when needed. The tool of
management in financial planning is the budget.
BUDGET
● Systematic programming of organizational
activities.
○ Sa bawat pagkilos, may cost.
○ Financial engineering), which looks at all
parameters or economic factors and then
they will project what would be the
potential growth for next year.
○ GDP
○ Balance between revenue generation and
expense generation.

Example: ZERO-BASED BUDGETING

● Starting the budget process from zero figure
SETTING UP A CLINICAL LABORATORY
and justifying and researching every cost that
Building Expenses 1.5 M will be incurred before arriving at a final
budget.
Machine/Equipment Expenses 4M ○ For instance, when you are still starting up
your clinical lab.
Salaries 45, 000/worker

Utilities 50, 000/month BUDGET

● Divided into anticipated income and expenses.
Tax (30%) 1M
INCOME / REVENUE
● Based on their costs and on the amount of ● Patient days, services rendered per patient day
resources available. ● Collection / Income - Expenses = Gross Profit
● The charges that may be made for these
LABORATORY BUDGETING services.
● Ongoing process that culminates annually ● Can either be:
with the expense projections for the coming ○ Products - anything you can see, feel, etc. /
year. tangible.
● Forecasts are made in accordance with the ○ Services - anything you can experience.
chart of accounts.
● Divided into quarters. These three-month Example:
intervals represent the best times for NET INCOME
expenditure modification.
Total Revenue 100 M
HOW TO PREPARE BUDGETS?
Total Expenses 80 M
HISTORICAL
Gross Income (Revenue - Expenses) 20 M
● Use data from previous year’s revenue and
expenses. Other Expenses 10 M
○ You’re going to look at the forecast of what
transpired this year and last year, and then Net Income (Gross Income - Other 10 M
Expenses)
you will be able to project what next year
would look like.
EXPENSES / COSTS
GROWTH FACTOR PROJECTION ● Involve personnel costs which amounts to
● Forecasting future revenues and expenses by about 70% of total expenses.
factoring the desired growth projection. ● Materials, leases and contracts and overhead
○ If economists are saying that we will be costs.
able to grow 10% next year based on their
statistics or mathematical projection.

2H-MT | A.Y. 2022-2023 Page 2 of 7

 OVERHEAD COSTS 6. Subscription and dues - refers to international
● Usually include interest on debts, utilities, organizations
phone, building maintenance and various 7. Hospital administrative assistance
other costs that can not be allocated to a 8. Telephone
specific area. 9. Housekeeping
● Related to the operations but are not specifically 10. General maintenance
identified to one particular service; it is shared by 11. Electricity
many other services. 12. Building depreciation
13. Taxes
PERSONNEL COSTS a. Payroll
● Salaries of permanent employees who are b. Sales
already working at the start of the fiscal year. 14. Insurance
● Additional personnel may be anticipated (or a. General liability
reductions may be planned). b. Woman’s compensation
c. Group health
SUPPLIES d. Others
● Can be estimated on the basis of previous 15. Miscellaneous
experience.
● New equipment is anticipated, and changes FINANCIAL ACCOUNTING STATEMENTS
made in supplies, etc. BALANCE SHEET
● Statement of financial position, it shows the
CHART OF ACCOUNTS lab’s financial situation at a given point in
1. Salaries time. It contains the assets (cash, receivables,
a. Exempt - No overtime pay IS GIVEN, property, equipment, inventory)
USUALLY TO managers and admin ○ Magkano ang cash na available? Magkano
personnel. ang pautang? Magkano ang value ng
b. Non-exempt - Entitled on overtime pay clinical lab? Magkano ang inventory?
like the regular/ordinary employees that
are not managers nor admin personnel. INCOME STATEMENT
2. Supplies - Things that you need to buy ● Shows revenue generated and expenses
3. Equipment incurred over a period of time.
a. Purchase ○ Includes total revenue, total expenses,
b. Rental gross profit, other expenses, and net
c. Lease income (na irereport sa BIR and dun sila
d. Maintenance - refers to the maintenance magtatax)
of the machines
e. Depreciation - pagbaba ng value ng isang STATEMENT OF CASH FLOW
bagay (ex. iPhone - it depreciates) ● Shows the inflow and outflow of cash
● Kapag bumili ng machine worth 5 (operations, investments, and financing).
million, after a year, bumababa ○ Describes paano ginastos yung pera
yung value. ○ Inflow - magkano nakolektang pera
● Usually after several years, or ○ Outflow - magkano yung nilabas na pera
when PMS is not given to an
equipment. TOOLS FOR FISCAL DECISION MAKING
● Depreciation is fast. 1. Laboratory workload reporting
4. Reference laboratory fees - budget when 2. Depreciation/Payback period
magpapadala ng samples sa NRL 3. Cost-finding/Cost-revenue analysis
5. Continuing education travel

2H-MT | A.Y. 2022-2023 Page 3 of 7

 LABORATORY WORKLOAD REPORTING
● Defined as one minute of technical, clerical,
and aide time.
○ There are 60 minutes in an hour, kung sa
60 minutes na yun busy ka mag CBC, then
your total workload for that period is 60
minutes/hr. So, 100% productivity. However,
kung 30 minutes dun ay nagtitiktok ka,
only 30 minutes were spent. Therefore, only
50% productivity.
● In actual practice, the average workload
productivity in most laboratories is in the
range of 30-55 workload units per hour.
INCLUDED FOR FISCAL DECISION-MAKING ARE:
In an ideal situation:
● There should be productivity of 60 workload units
(that is 60 min of productive work) for each hour of
worked time.
● The closer the workload units per hour IS TO 60, the
nearer (It would seem that) the laboratory is to
operate at 100% efficiency.
COMPONENTS OF WORKLOAD
1. Direct Effort - refers to the personnel labor
effort involved in direct patient specimen
handling as it processes from specimen to
result.
*ikaw talaga yung gumawa
2. Indirect Effort - list of tasks that staff
members perform that isn’t directly related to
the patient, specimen, or test results. (Ex.
Calibration, control, maintenance, stocking of
supplies, answering phone calls, inquiries, etc.)
*yung task is hindi simply related sa specimen.
Halimabawa, calibrate of machine (indirect).
3. Operational Needs - non-procedural-based
responsibilities that consume staffing
resources. The difference between these and
indirect-effort tasks is that operational needs
are further removed from the testing process
and are more operational in nature. (Ex.
Trainings, break/lunch, meetings, etc.)
*includes break time and training time or known as
“our time”
BASIC CALCULATION FOR DIRECT EFFORT
● In this example, it takes five minutes for a
MedTech to interpret 1 patient Clinical
Chemistry Panel tests, including keying the
2H-MT | A.Y. 2022-2023
results into the laboratory information system
(LIS) and validating the result. If the MedTech
does this for 100 patients per day:
○ This is an example of direct effort because
ikaw mismo ang gumagawa sa patients.
5 minutes per patient x 100 occurrences/day =
500 minutes/day
500 minutes/day ÷ 60 minutes/hour = 8.3
hours/day of direct effort
8.3 hours/day ÷ 8 hours/FTE = 1.04 FTE
Note: FTE, or full-time equivalent, is based on a
40-hour workweek. However, the 40 hours can
be accomplished with one staff member
working 40 hours or two working 20 hours each,
etc.
● CAP workload unit = 1 minute of technical,
clerical, and/or aide time
● Productivity (units/hr) = total workload
units/hour
● The more highly automated disciplines, such
as chemistry and hematology, report the
highest ratios.
PRODUCTIVITY UNITS
● Comparing current with previous productivity
in (sections within the laboratory) (with other
comparable laboratories).
● If a laboratory’s productivity consistently runs
over 60, then the laboratory may be
understaffed and need additional personnel
support.
● Laboratories are encouraged to use this tool
since it provides useful information for budget
forecasting and determining future staffing
levels.
DEPRECIATION
● The value of the equipment/capital expense
diminishes over an extended period of time
and usage.
● Depreciation is an accounting process by which a
company allocates an asset’s cost throughout its
useful life. In other words, it records how the value
of an asset declines over time.
● The purpose of recording depreciation as an
expense is to spread the initial price of the asset
over its useful life.
Page 4 of 7
 ● Pagbaba ng value ng machine
PAYBACK PERIOD
● Determines how long it will take to recover
cash outlays, or to recover their investment.
Example: In hematology, the income is 10M per
year and you bought the machine for 5M
○ payback = 5M/10M
○ payback = 0.5 year/6 months
○ in 6 months, narecover mo na yung
investment
● A urinalysis instrument costs Php180,000, has
a life expectancy of 5 years, Salvage Value of
50,000 and will produce Php 95,000 of annual
income. What is its annual depreciation value?
Its payback period is?
COST FINDING
● A means by which a laboratory documents its
cost for performing a particular procedure.
● Establishes its charges on the involved direct
and indirect cost.
● Cost finding should be done by a laboratory
personnel in consultation with the fiscal staff
of the hospital.
● This combination is necessary since the
laboratory staff can analyze steps involved in
performing procedures while the fiscal
personnel are needed to provide the indirect (or
overhead) expense.
● To assist in preparing the data for submission
to the hospital administration, board of
trustees and third party payer, for approval.
● Two general types of costs involved in the
operation of a laboratory in costing any single
procedures:
○ Direct costs
○ Indirect costs
2H-MT | A.Y. 2022-2023
DIRECT COSTS
● Are costs of material supplies and personnel
time directly attributed to specific
measurements or examinations
● Such costs include the allocated portion of
utilities, laboratory and institutional
administrative expenses, building depreciation
and janitorial services.
INDIRECT COSTS
● Are costs that are not directly accountable to a
cost object.
● Includes administration personnel and
security costs
● These are the costs which are not directly
related to production.
● Some indirect costs may be overhead costs.
But some overhead costs can be directly
attributed to a project and are direct costs.
● May either be fixed or variable
○ The concept of fixed and variable costs
is useful in analyzing the effects of
changing volumes of determination or
expense and revenue.
FIXED COSTS
● Are constant overtime regardless of volume of
determinations
● Depreciations, supervisor salaries and rental
charges are examples of fixed costs.
● The laboratory will incur these charges at a
fixed rate that should vary with reasonable
charges in work volumes.
● Fixed costs are much larger than variable costs
since personnel costs usually account for 60%
to 70% of the total budget of most hospitals.
VARIABLE COSTS
● Costs (for items such as supplies and
reagents) which will vary in a relationship to
the volume of determinations.
In general, therefore, the greater the workload performed by
the laboratory, the less per unit cost. Decreases in per unit
cost, however, are eventually limited regardless of further
increase in volume because of the necessity for incremental
additions of personnel and/or equipment.
Page 5 of 7

CAPITAL COSTS Associated with physical
assets, equipment,
instruments that have a life
span of more than 1 year and
often depreciated over a 5 year
period. Or may cost more than
a set amount. (ex: >Php
250,000)
OPERATING COSTS Costs used for day-to-day
operations. General costs of
doing business. May also refer
to costs to produce test results.
Includes Direct and Indirect
costs.
DIRECT COSTS Related to all components
associated with performing the
test. (supplies, equipment cost,
QC, salaries)
INDIRECT COSTS Not directly contributing to
producing the test. Overhead,
administrative, and other
expenses shared by many
components in the lab.
FIXED COSTS Expenses that do not fluctuate
when the volume of work
changes on a daily basis. (rent,
depreciation, taxes)
VARIABLE COSTS Respond directly to any change
in workload, will vary in
relationship with the volume of
tests. (reagents, supplies labor
costs in cases of overtime,
some overheads)
COST-REVENUE ANALYSIS
● A tool to determine the efficiency of
management and to calculate the break-even
point so the laboratory manager can set the
2H-MT | A.Y. 2022-2023
charges that appropriately cover the costs as
well as plan policy for future laboratory
services.
● If the lab can expect to perform services that
exceed this point, it can EXPECT A PROFIT. If
the revenues cannot cover the associated
costs, the lab will EXPERIENCE A LOSS.
INCLUDED FOR FISCAL DECISION-MAKING ARE:
In Laboratory workload reporting:
● A workload unit is defined as one minute of
technical, clerical, and aide time.
In an ideal situation:
● There should be productivity of 60 workload units
(that is 60 min of productive work) for each hour of
worked time.
● The closer the workload units per hour IS TO 60, the
nearer (It would seem that) the laboratory is to
operate at 100% efficiency.
In actual practice:
● The average workload productivity in most
laboratories is in the range of 30 to 55 workload
units per hour.
EXAMPLE:
Cost of all supplies to run 200 tests of
HBa1c = PhP 50,000
Price of Test = Php 500
Total Revenue is Php 107,000
COST PER TEST
= Cost of all supplies used (reagents, instrument
cost, labor etc.) / # of reportable tests
= Php 50,000 / 2200 tests of HBa1c
= Php 250
REVENUE PER TEST
= Total Revenue / Total Number of tests reported
= Php 107,000 / 200 tests of HBa1c
= Php 535 per test
PROFIT PER TEST
= Revenue per test - Cost per test
= Php 535 - Php 250
= Php 285 per test
Cost per test = 50,000 by 200 tests to get Php250.00,
Established Average Price of Test: Php 500
Page 6 of 7
Total Revenue is Php 107,000 - total revenue from hba1c BE TEST VOL= 2,222 TESTS
regardfless of where it was done. It means some department BE REVENUE = 1,188,889
may have different prices of hba1c (mark-up) depending on
location. Example, Emergency Room and Presidential Suite
may be priced higher than out-patient department.

This means the laboratory profits/ may earn 285 pesos per
HBa1c done in the lab.

BREAKEVEN ANALYSIS (TEST VOLUME)

How many tests are done to breakeven?

Total Fixed Cost (Annually) = Pho 800,000

Revenue per test = Php 535
Variable cost per test = Php 175

= Total Fixed Cost of lab / Revenue per test - Variable

cost per test
= Php 800,000 / Php 535 - Php 175
= Php 800,000 / Php 360
= 2,222 test to breakeven

Cost per test = 50,000 by 200 tests to get Php250.00

Total Fixed Cost (Annually) = P 800,000
Revenue per test = P535,
Variable cost per test = P175
BE TEST VOL= 2,222 TESTS
BE REVENUE = 1,188,889

BREAKEVEN ANALYSIS (REVENUE)

How much to breakeven?

Total Fixed Cost (Annually) = Php 800,000

Revenue per test = Php 535
Variable cost per test = Php 175

= Php 800,000 / (Php 535 - Php 175)/Php 535

= Php 800,000 / 0.67
= Php 1,194,030 to breakeven

Cost per test = 50,000 by 200 tests to get Php250.00

Total Fixed Cost (Annually) = P 800,000
Revenue per test = P535,
Variable cost per test = P175
2H-MT | A.Y. 2022-2023 Page 7 of 7