BSMLS 3J | LABORATORY MANAGEMENT | PRELIMS | 2023-2024 | WEEK 1 | CLINICAL LABORATORY

○ Guide patient management

CLINICAL LABORATORY ○ Monitor efficacy of therapy
● A Facility that is involved in the (a) pre-analytical, (b) analytical, ● QUESTION: Most common requested test in a normal hospital
(c) and post-analytical procedures setting
○ where tests are done on specimens from the human ○ CBC
body to obtain information about the health status of
■ Why? Because it can cover a lot of
a patient for the prevention, diagnosis, and treatment
of diseases (AO 2021-0037) diseases through examining the blood
tests (high/low result) → determine what
PRE-ANALYTICAL PROCEDURE kind of disease the patient has
● Patient identification ● To successfully achieve its goal, a laboratory must use:
○ Identify the patient
■ In-patient PPS ○
○
Medical, scientific, and technical expertise
Resources (personnel, laboratory and data
■ Out-patient processing equipment, supplies, and facilities)
● Precaution ○ Organization, management, and communication
○ 3 types of precaution:
skills
■ Droplet precaution
● Involves risk of droplets that can ● QUESTION: If the equipment used is not obsolete/up to date,
spread disease do you think you can utilize the efficiency of your lab despite
● Ex. of disease having the skills?
○ Pneumonia, Influenza ○ NO
■ Airborne precaution
● Highly contagious LABORATORY DEPARTMENTS
● Ex. of disease
● Laboratory Departments
○ Tuberculosis (TB)
■ Contact precaution ○ Hematology
● Gloves are essential to prevent ■ CBC, peripheral blood smear, blood typing
the spread of infection ○ Hemostasis and Coagulation
● Ex of disease ■ Tube usually used for testing hemostasis
○ HIV, Hepatitis B ● Light blue tube
● Special considerations
○ Clinical Microscopy Parasitology
○ Time samples
■ Q’s ■ Stool exams and urine analysis
■ There is a time interval for collection of ○ Clinical Chemistry
sample ■ Involves the analytes, enzymes, proteins,
■ Ex. Q1, Q2, Q4, Q6, Q8, Q12 etc.
○ PIDs (?) *inaudible* ○ Blood Bank and Transfusion Services
■ Cross-matching
ISSUES WITH PRE-ANALYTICAL PROCEDURES ■ Blood typing
● Mislabeling ● In some areas, Hematology does
○ Improper naming of specimens
blood typing since it uses EDTA
■ Cause changes in the results that may
cause the patient to die ● Commonly done in blood bank
● Improper handling of specimens and transfusion services
○ Major issue in pre-analytical procedure ■ Blood Donation
● Improper mixing of tubes ○ Immunology-Serology
● Improper collection of specimen ■ Antigen-Antibody test
○ Molecular Diagnostics
ANALYTICAL PROCEDURE
■ PCR test
● Process of running the sample
○ Microbiology
● Examples
○ running of samples ■ Culture and sensitivity
○ running of controls ○ Histopathology and Cytology
○ calibrating of machines to conduct a test ■ For biopsy and other tests
GOAL OF THE LABORATORY: QUALITY
ISSUES WITH ANALYTICAL PROCEDURES ● Safe, comfortable phlebotomy experiences provided to all
● Improper calibration of machines patients
● Improper mixing of reagents
● Properly collected and labeled specimens provided for testing
● Fluctuations
● Timely, accurate test results and reports provided to
physicians and other healthcare personnel
POST-ANALYTICAL PROCEDURE
● Informative and helpful consultations and answers to
● It involves the interpretation, validation, and encoding of results
questions
ISSUES WITH POST-ANALYTICAL PROCEDURES
● Clerical errors THE LABORATORY WORKFLOW
● Improper interpretation of results ● Transforms a test order into a results report
○ See if a doctor orders a test
LABORATORY ○ Sample collection (body fluids) → transport →
● 70% of all medical decisions are based on laboratory results receiving → accessioning
(Silverstein, 2003) ○ Undergo testing and review
● Purpose ○ If after the testing, there are problems identified →
○ Detect disease or predisposition to disease the technologist will interpret the results → report the
○ Confirm or reject a diagnosis results
○ Establish prognosis

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BSMLS 3J | LABORATORY MANAGEMENT | PRELIMS | 2023-2024 | WEEK 1 | CLINICAL LABORATORY

○ Deliver the results to the doctor (bring it to the ● A single, core lab provides high volume, routine testing
reception area) ● One or more other labs perform highly specialized functions
○ Report preparation and report delivery ○ Microbiology
○ Cytogenetics
○ Accurate test results and interpretation back to the
○ Molecular diagnostics
physician ○ Cytology/histopathology
○ Stat tests
● In the lab, sections are regionalized = separate sections
○ Each section has its own specialized function

LABORATORY PLANNING AND DESIGN

● Location: situated in an area that is accessible both to clients
and staff
○ The area should be near populated areas
○ Managing a lab is also a business, therefore, there is a
need to earn in order to maintain and manage a lab
○ Location is very important
TAKE NOTE ■ to attract people
● The laboratory does not perform or control some of the ■ to avail services with ease
processes in the workflow ● Privacy: provide audible and visual privacy to clients from
specimen collection to releasing of results
● Test ordering may be done by other authorized health
○ There should be a private area during collection
professionals ○ Discussion with the patient, such as test results,
○ Test ordering may also be done by an institution or an should not be heard outside
organization ○ Maintain confidentiality at all times
● The laboratory does not collect all samples to be tested or ● Conformance with building laws: planning and design,
examined construction, renovation, maintenance, and repair of facilities
(PD 1096 or the National Building Code)
○ Only the appropriate sample is collected for a
○ Should adhere to the standards of the National
particular test Building Code
● IMPORTANT: ■ Avoid damages
○ Correct performance of all activities in the workflow ■ Provide floor plan
is a MUST, whether or not the laboratory has control ■ Good quality of materials
over them ● Ventilation: acceptable air changes per hour (4-12)
○ Importance: laboratory handles toxic substances; A
proper ventilation reduces the incidence of
LABORATORY DESIGN AND SERVICE MODELS
transmitting diseases to the client
● Laboratory tests: from POCT to highly sophisticated lab tests ● Spaces Required:
○ POCT is also known as: ○ General Administrative Services and Public Areas
■ Bedside testing ○ Clinical Working Area
■ Poor man’s test ○ Support Services Area
○ Highly sophisticated lab tests
■ PCR GENERAL ADMINISTRATIVE SERVICES AND PUBLIC AREAS
● Internet access has added a level of transparency ● Business Area
○ Provides ease of delivery of results to physicians and ○ Reception area for information and business
transactions, receiving of specimen, and releasing of
stations
results
○ Currently, submission of test results are ■ To submit sample for testing, go to
automatically submitted to the stations receiving and leave it together with the
■ Not printed out then transferred anymore request
○ Health information system will be possible through ○ Waiting area for clients
internet ● Collection Area
○ Divided into 3:
● Functional design of the lab
■ Specimen collection area
○ Before: discrete or separate lab sections ■ Extraction area - for blood
○ Current: ■ Drug testing collection
■ Single testing platform (single analyzer) ● Toilet Facilities
■ Workcell (2 or more linked instruments) ○ May be within the premises or adjacent to the
■ Total laboratory automation (preanalytical laboratory
to postanalytical) ○ Conveniently accessible toilet to the public
○ Separate toilet for the staff

HUB AND SPOKE MODEL

CLINICAL WORKING AREA
● Sufficient to accommodate its activities and allow for smooth
and coordinated workflow
○ Should facilitate the work environment
○ Materials/machines should be proportionate to the
size of the clinical working area
● Sufficient and appropriate storage spaces and conditions
provided for laboratory specimens, documents, records,
manuals, equipment, reagents, supplies, slides, and tissue
blocks

SUPPORT SERVICES AREA

● Sufficient storage for records and supplies
● Regionalization ○ Outdated supplies; about 10 years ago

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● Sterilization room/area ● Floor-to-ceiling height: at least 2.6 meters

○ Or changing area ○ High ceiling
● Waste holding area ● Plumbing
● Staff pantry ○ Faucet should not be clogged
○ Food for staff ● Ventilation
● Other spaces for staff such as offices, conference room, ○ Artificial air conditioning shall be provided to attain
lockers, and changing room are optional HVAC requirements
○ Exhaust fans in the clinical working area with
SPECIFIC TECHNICAL REQUIREMENTS dedicated exhaust fans for Histopathology,
● Collection area for blood extraction shall provide space, Microbiology, and Clinical Microscopy
equipment, and furniture appropriate for its activity performed. ■ Directed outside; air must not recirculate;
○ With work counter/tray, space for patient seating, and airflow must be from clean to less clean
handwashing stations areas
○ Area should not be small; must be spacious ■ Exhaust fans in Clinical Microscopy:
○ Should have a handwashing station ● To remove odor
● Specimen collection area for urine/stool
○ May be located outside the main clinical laboratory, a SPACE
designated cubicle in a toilet facility, or a dedicated ● adequate area shall be provided for the people, activity,
toilet solely for specimen collection furniture, equipment, and utility
○ Could be anywhere as long as the sample is
transported within 30min to 1hr SPACE AREA IN SQUARE METERS
■ More than 1hr = not accepted in the lab GENERAL ADMINISTRATIVE AND PUBLIC
● Pathologist's area may be a separate room or a cubicle AREAS
○ Located adjacent to or within the clinical working
area for easy access to the clinical working area of Business Area
the laboratory Reception Area 5.02 m2/staff
● Entrance to the clinical working area must not be in high traffic Waiting Area 0.65 m2/person
areas Collection Area
○ Handwashing areas at the entry and exit points of the
Extraction Area (for blood) 6.00 m2/chair or couch
clinical working area is required
■ To avoid contamination and taking in Specimen Collection Toilet (for stool and 1.67 m2
infections urine)
○ Must: No obstruction in the clinical laboratory area Public Toilet 3.06 m2
○ The door directly to the clinical laboratory area should Staff Toilet 1.67 m2
be spacious
Pathologist Area 5.02 m2/staff
■ for easy accessibility when there is delivery
of specimen SUPPORT SERVICES AREA
● Sections of the laboratory shall be provided with a Storage Area for Supply and Records 4.65 m2 or
stainless-steel sink with a depth of at least 8 inches and a 1.2 m2/storage unit
gooseneck faucet Sterilization Unit / Room 4.65 m2
○ Use of gooseneck faucet:
Waste Holding Area 4.65 m2
■ The soap in one’s hand will not drip onto the
faucet Staff Pantry 1.40 m2/person
■ Safer Conference Room (Optional) 1.40 m2/person
■ Designed to not contaminate the water even
if the hands have soap MATERIAL SPECIFICATION
● Each section of the laboratory shall be properly identified ● Wall and partition: structurally sound, safe, and sturdy
○ Separate rooms are required for Histopathology, ○ No damages during an earthquake and any other
Microbiology, and Molecular Pathology calamities
■ Histopathology and Microbiology room ● Flooring: durable, readily cleanable, and wear-resistant
● should be sterile ○ Seamless and self-coving to a height of 6 inches
● Involves deadly chemicals towards the wall
■ Clinical Microscopy room ○ Should be wiped immediately after spillage
● Usually enclosed with exhaust ● Work counters: preferred width is 30 inches
fan to prevent the spread of the ○ Should not support bacterial growth, durable,
odor non-porous, smooth and easy to clean, and stain and
○ Placard should be visible dirt resistant
● Toilets and other staff amenities: outside the clinical working ● Doors: no door shall be less than 800 mm; preferably
area self-closing
● Biosafety cabinets and isolation hoods: away from areas with ○ Main door: at least 900 mm
fluctuating air supply ○ Rooms/sections with large instruments/equipment:
○ Double door: minimum width of 900mm
■ 1. For biosafety
■ 2. Main section
● Fire safety: conform to RA 9514 (Fire Code of the Philippines)
○ No more than 23 meters from the clinical working
area to any exit door
● Corridors: at least 1.2m or 4ft minimum width
● Clearances
○ 1.2m or 4ft: wall to work counter
○ 1.52m or 5ft: work counter to work counter
■ Machine area
● Hands-free eyewash unit with handwash unit: within 30 meters
of work access
● Lighting: no exposed or dangling wires, no unwanted glare
○ With convenient outlets
■ No octopus wiring

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Sample Floor Plan of Laboratory

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 LABORATORY MANAGEMENT

PRELIMS TOPIC 2. LABORATORY WORKFLOW AND LABORATORY SAFETY

Lecturer/s: Ms. Angela Dela Peña, RMT
August 17, 2023

THREE PHASES OF TESTING PROCESS CAPAIGATPIC !!!

Cortisol Peaks 4-6 a.m., lowest 8 pm - 12 am;
● Pre-analysis 50% lower at 8pm than at 8am;
○ Activities that take place before testing increased with stress
○ Test ordering and sample collection
● Analysis Adrenocorticot Lower at night; increased with stress
○ Activities that produce a result ropic hormone
○ Running a sample on an automated
analyzer Plasma renin Lower at night; higher standing than
activity supine
● Post-analysis
○ Patient reporting and result interpretation
Aldosterone Lower at night

PRE-ANALYSIS Insulin Lower at night

● 32-75% of all testing errors occur in this phase
● Errors in this phase create rework or additional Growth Higher in afternoon and evening
investigations that may cause unnecesary hormone
procedures and costs to the patients and to the
healthcare system Acid Higher in afternoon and evening
phosphate

FACTORS OF PRE-ANALYSIS Thyroxine Increases with exercise

1. Pre-collection variables Prolactin Higher with stress; higher with levels

at 4 and 8 am and at 8 and 10 pm
2. Specimen collection
3. Specimen transport
Iron Peaks early to late morning;
4. Specimen processing decreases up to 30% during the day

PRE-COLLECTION VARIABLES Calcium 4% decrease supine

● Time variations
○ Cortisol: higher in the morning (diurnal SPECIMEN COLLECTION
TEDSPAG !! variation) ● Test order
○ Microfilaria: best at night ○ One of the most frequent errors: selecting
○ Malaria: between chills (multiple smears) the wrong lab test
● Exercise ○ May be electronic or in writing
● Diet: glucose and triglycerides increase after eating ○ Verbal requests may be made during
● Stress: increases ACTH, cortisol, and emergency situations and should be
catecholamines documented
● Posture ■ Official lab requests must be
○ Upright: increases hydrostatic posture ~ placed after the blood is drawn
which increases protein concentration ○ ‘add-ons’
○ From supine to sitting position: increases ■ Additional tests requested on a
hemoglobin, hematocrit, and RBC count specimen previously collected
○ Prolonged torniquet application may ■ Problems: specimen is not the
increase serum enzymes, proteins, and proper type, residual volume is
protein-bound substances insufficient, storage conditions
○ Patients should be advised to avoid result in analyte deterioration
changes in the diet, consumption of
alcohol, and strenuous exercise 24 hours ● There should be lab policies on the following:
prior to blood collection. ○ If a patient refuses to have blood drawn
● Age ○ If the patient was unable to be drawn
● Gender ○ If the patient is unavailable
○ If the patient is combative
○ If the patient becomes ill or faint

Made by Miguel Astronomo 1

 ● Time of Collection SPECIMEN PROCESSING
○ ASAP Collection ● Ideally, all measurements should be performed
○ STAT collection: collected and analyzed within 45 minutes to 1 hour after collection
immediately ● Plasma or serum is preferred for most biochemical
○ Timed specimens: OD, TID, BID, Qn (e.g. determination
Q12, Q8, Q6, Q4, Q1) ○ Serum is the specimen of choice due to its
■ OD: Once a day simplicity in collection and handling and no
■ TID: Ter in die - thrice a day interference from anticoagulants
■ BID: Bis in die - twice a day ● Serum or plasma must be stored at 4 to 6 degrees
■ Qn - Hour interval Celsius if analysis is to be delayed for longer than 4
○ Trough specimens: reflect the lowest level hours
in the blood; drawn 30 minutes before the
drug is administered CHANGES IN URINE WITH DELAYED TESTING
○ Peak specimens: drawn shortly after
medication is given
○ 2-hour postprandial
○ Glucose tolerance test RESULT REASON
HCNISIDUC
REASONS FOR SPECIMEN REJECTION Changes in color Breakdown or alteration of
● Hemolysis/lipemia chromogen or other urine constituent
(e.g. Hemoglobin, melanin,
● Clots present in an anticoagulated specimen
homogentisic acid, porphyrins)
● Non-fasting specimen when test requires fasting
● Improper blood collection tube Changes in odor Bacterial growth, decomposition
● Short draws, wrong volume
● Improper transport conditiosn (e.g. no ice for blood Increased Increased bacteria, crystal formation,
gases) turbidity precipitation of amorphous material
● Discrepancies between requisition and specimen
label Falsely low pH Glucose converted to acids and
alcohols by bacteria producing
● Unlabeled or mislabeled specimen
ammonia, carbon dioxide (CO2) lost
● Contaminated specimen/leaking container
Falsely elevated Breakdown of urea by bacteria
SPECIMEN TRANSPORT pH forming ammonia
● Transport of blood, urine, bodily fluids, and tissue
specimens from collection site to the lab False-negative Utilization by bacteria (glycolysis)
● Excessive agitation must be avoided to minimize glucose
hemolysis
● Samples for bilirubin testing must be protected from False-negative Volatilization of acetone, breakdown
ketone of acetoacetate by bacteria
light
● For local, onsite transport, pneumatic tube systems False-negative Destroyed by light; oxidation to
may be used
○ Rapid, efficient, and cost-effective
bilirubin biliverdin
gkbun
○ Blood specimens are placed in a carrier False-negative Destroyed by light
with liners to prevent leakage and padding urobilinogen
to ensure it remains intact
False-positive Nitrite produced by bacteria after
nitrite specimen is voided
PNEUMATIC TUBE SYSTEM
False-negative Nitrite converts to nitrogen and
nitrite evaporates

Increased Bacteria multiply in specimen before

bacteriuria analysis

Disintegration of Unstable environment, especially in

cells/casts alkaline urine, hypotonic urine, or
both

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 CENTRIFUGATION PHASE ● Careful planning and compliance with the laws
● A centrifuge uses centrifugal force to separate minimuze undesired outcomes
phases of suspension by different densities
● One should look for a centrifuge with the highest ● Accidents are often caused by
possible centrifugal force and not the rotational ○ Inexperience
speed ○ Ignoring known risks
● Relative Centrifugal Force (RCF) = (1.118 x 10-5) x r ○ Pressure to do more
x (rpm)2 ○ Carelessness
○ r = radius in cm between the axis of ○ Fatigue
rotation and the center of the centrifuge ○ Mental preoccupation
tube
○ Rpm = speed in revolutions per minute BIOLOGICAL HAZARDS
● Exposre occurs from ingestion, inoculation, tactile
ANALYSIS
contamination, or inhalation of infectious material
● Sample Introduction and transport to cuvet or
● PPE must be worn at all times
dilution cup
○ All PPE must be removed before leaving
● Addition of reagent
the lab area
● Mixing of sample and reagent
● Incubation
● Detection and calculations CHEMICAL HAZARDS
● Readout and result reporting ● Evaluation of hazards by manufacturers
● Hazard communication programs for employees
POST-ANALYSIS ○ Maintain inventory
● Alarms and flags ○ Maintain MSDS in English
○ Flags for problem specimens ○ Labels must not be defaced or removed
■ Inadequate samples ○ Information and training
■ Presence of high concentrations ○ Designate responsible persons for the
of interfering substances (lipids, program
hemoglobin) ○ Must adhere to OSHA permissible
○ Flags for specimens that require additional exposure limits
analysis with another method
■ Qualitative abnormalities of blodo ERGONOMIC HAZARDS
cells: should prepare blood smear
● Employers must develop a program to address
for further evaluation
work-related problems that include cumulative
○ Flags for problematic results
trauma disorders (constant repetitive actions)
■ If values fall outside the linear
○ Repetitive pipetting
range: automatic or manual
○ Keyboard use
dilution and then reanalyzed
○ Resting wrists/arms on sharp edges
● Critical values
● Human error may be a causative factor when
○ Also known as panic or alert value
individuals push themselves beyond their limits and
○ Requires rapid communication with a
when productivity limits are too high
healthcare provider who can provide
necessary medical interventions
LABORATORY HAZARD PREVENTION STRATEGIES
LAB SAFETY Work practice controls
● The clinical lab exposes the staff and potentially the ● General procedures/policies that mandate
public to a variety of hazards: measures to reduce or eliminate exposure to
○ Infectious patients hazard
○ Infectious patient specimens
○ Potentially hazardous chemicals and EXAMPLES:
equipment ❖ Hand washing after each patient contact
○ Ergonomic/environmental hazards ❖ Cleaning surfaces with disinfectants
○ Acts of God/ force majeure ❖ Avoiding unnecessary use of needles and sharps
○ Epidemic emergencies and not recapping
❖ Red bag waste disposal
● Injuries and harmful exposures can negatively affect ❖ Immunization for hepatitis
the lab financially ❖ Job rotation to minimize repetitive tasks
○ Reputation due to bad press ❖ Orientation, training, and continuing education
○ Potential lawsuits ❖ No eating, drinking, or smoking in lab
○ Lost workdays and wages ❖ Warning signage
○ Damage to equipment
○ Poor staff morale

Made by Miguel Astronomo 3

Engineering controls
● Safety features built into the overall design of the
product

EXAMPLES:
❖ Puncture-resistant containers for disposal and
transport of needles and sharps
❖ Safety needles that automatically retract after
removal
❖ Biohazard bags
❖ Splash guards
❖ Volatile liquid carriers
❖ Centrifuge safety buckets
❖ Biosafety cabinets and fume hoods
❖ Mechanical pipetting devices
❖ Computer wrist/arm pads
❖ Sensor-controlled sinks or controlled faucets

Personal protective equipment

● Barriers that physically separate the user from a
hazard

EXAMPLES:
❖ Nonlatex gloves
❖ Gowns and lab coats
❖ Masks
❖ Face shields
❖ Protective eyewear
❖ Eyewash station
❖ Chemical-resistant gloves; freezer gloves; thermal
gloves

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 LABORATORY MANAGEMENT

PRELIMS TOPIC 3. RULES AND REGULATIONS OF CLINICAL LABORATORIES IN

THE PHILIPPINES
Lecturer/s: Ms. Angela Dela Peña, RMT
FULL TRANSES MASTERLIST: https://bit.ly/masterli_st

ORGANIZATION AND MANAGEMENT

● Updated organizational chart (with names, pictures,
Qualifiaction of Certified Clinical Certified
and designations) must be displayed in a Head of Pathologist Anatomical
conspicuous area Laboratory Pathologist
● The laboratory's vision, mission, and goals and the
DOH-LTO must also be displayed A. Clinical Laboratory
● Written policy on management review and
compilation of documented minutes of meeting Primary ✓
● Supporting documents for evaluation and
monitoring of activities such as records, logbooks, Secondary ✓
checklist of supplies, inspection report, purchasing
Tertiary ✓
and procurement and acceptance of supplies, etc.
● Written policy and procedure for handling Limited*
complaints/ client feedback
○ Available forms Anatomic ✓
○ Records and action taken Laboratory
● Suggestion box must be visible to clients
Molecular Laboratory
HUMAN RESOURCE MANAGEMENT
● Written policies and procedures on hiring, Genetics**
orientation, and promotion of personnel at all levels
Immunohematolo ✓
● Written policies and procedures for staff gy
development and training
● Proof of training through certificates, memos, Infectious ✓
budgetary allocations, written reports
* It will depend on the limited services to be provided
● Written policies and procedures on discipline,
**A pathologist or a licensed physician who is trained in the
suspension, demotion, and termination of personnel
management, principles and methodology of these
at all levels
specialized services that are being provided shall head this
● Written job description or duties and responsibilities
type of laboratory
of all laboratory personnel
● List of personnel with designation
REGISTERED MEDICAL TECHNOLOGISTS
● Areas of assignment indicated in the posted work
schedule
At least 1 competent RMT per assigned area
RMTs with designated assignments must have proof of
HEAD OF THE LABORATORY: THE PATHOLOGIST
trainings
Proof of supervisory at least once a week for physical visit
● rHIVda: certificate of proficiency (SACCL)
OR once a month physical visit with at least twice a week of
● AFB microscopy: certificate of training on DSSM
supervisory calls and or video conferencing
(NTRL)
● For HOL of hospital-based laboratory: supervisory
● Bacteriology: certificate of training in bacteriology
physical visit of at least once a week
(RITM and other RITM- recognized institutions)
● Proof of qualifications:
● Malaria smear: certificate of training in malaria
○ Updated resume
smear (RITM)
○ PRC certificate and valid PRC ID
● Biosafety and Biosecurity Officer: certificate of
○ Board Certificate and a Certificate of Good
training (RITM and/or UP- NTCBB)
Standing from PSP
○ Notarized employment contract
○ Relevant training certificates
○ Proof of immunization

Made by Miguel Astronomo and Joshua Kintanar 1

 STAFFING PATTERN FOR RMT ANALYSTS ● Guidelines in the operation and maintenance of the
laboratory including policy on security of supplies,
1. Clinical Laboratory for Clinical and Anatomic specimens, and confidentiality of records
Pathology ● Laboratory services and corresponding prices are
accessible to the public
● Documented and updated policies and procedures
of laboratory services in each section/area
● Documented procedures for receipt and
performance of laboratory tests
● Documented procedures for reporting of results of
laboratory tests
● Documented procedures for the validation of
laboratory results prior to reporting
2. Clinical Laboratory for Anatomic Pathology - At
● Laboratory report forms bearing the name and
least one RMT per section
original digital signature with PRC ID number of the
3. Clinical Laboratory for Molecular Pathology - Will
head of the laboratory and the RMT analysts
depend on the services offered
● Updated records of results including entry,
releasing, and endorsement records
PHYSICAL PLANT, FACILITIES, AND WORK
● Documented procedures for reporting of workload,
ENVIRONMENT
quality control, inventory control, etc.
● Documented procedures for reporting and analysis
● Written policy and program for the proper
of incidents, adverse events, etc.
maintenance and monitoring of physical plant and
● Documented procedure for the retention of records
facilities
which follows DOH standards
○ Proposed schedule for preventive
○ Laboratory logbooks: dispose 2 years after
maintenance
the last entry provided that no item is
● Written protocols on laboratory biosafety and
subject of a medico-legal case
biosecurity
○ Laboratory results: must be disposed after
● Policy on disposal of wastes that conform with
15 years
Healthcare Waste Management Manual and RA
○ Laboratory requests: dispose 1 year after
6969 (Toxic Substances and Hazardous and
the release of the result
Nuclear Wastes Control Act of 1990)
● Documented Internal QAP including internal quality
● Notarized MOA with infectious waste, toxic, and
control and continuous quality improvement
hazardous substances hauler
● Updated QC reports conducted per test
● Proof of proper management of wastes from point
● Availability of reference materials and appropriate
of generation, segregation, disinfection, up to the
reagents and equipment used
final disposal
● Documented procedure in the actual performance
of EQAP activities
EQUIPMENT/INSTRUMENTS
● Certificate of Performance in EQAP with passing
rate
● List of available and functional laboratory equipment
● Documented procedures on referral and
● Regular schedule including frequency of preventive
outsourcing of examinations to another
maintenance and calibration
DOH-licensed clinical laboratory
● Record of repair reports
● Records of outsourced examinations (in the event
● Written policy on contingency plan in case of
of machine breakdown)
equipment breakdown
● Notarized MOA on test referrals
● DOH-LTO of referral testing laboratory
REAGENTS AND SUPPLIES
● Quality records of supplies/ reagents with expiration
date, their usage consumption, and disposal
● Certificate of Product Registration from FDA
including reagents, supplies, and equipment for
POCT and MCL
● Records of temperature monitoring
○ Room temperature
○ Refrigerator and freezer
● MSDS available for all reagents supplies and
accessible to all personnel at all times

ADMINISTRATIVE AND TECHNICAL POLICIES AND

PROCEDURES
● All documented policies, protocols, and procedures
are signed and approved by the head of the
laboratory

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 LABORATORY MANAGEMENT

PRELIMS TOPIC 4. Introduction to Management, Planning, and Organizing

Lecturer/s: Ms. Angela Dela Peña, RMT
FULL TRANSES MASTERLIST: https://bit.ly/masterli_st

MANAGEMENT INFORMATIONAL ROLES

Getting things done through people
ROLE DESCRIPTION EXAMPLES
● Focuses on task, achievement, people
Monitor Receives wide Handing all mail
Pursuit of organizational goals efficiently and effectively variety of and contacts,
● Efficiency: the means Information; categorized as
● Effectiveness: the end serves as nerve concerned -
center of interal primarily with
FUNCTIONS OF MANAGEMENT and external receiving
information of the information
● Planning
organization
● Organizing
● Leading/Directing Disseminator Transmits Forwarding mall
● Controlling information into organization
received from for information
1. PLANNING outsiders or other purposes; verbal
● Foundation area of management subordinates to contacts Involving
members of the information flow to
● Delivering strategic value
organization subordinates,
○ Specifying the goals to be achieved such as, review
○ Deciding what actions are needed to sessions
achieve the goals
Spokesperson Transmits Board meeting;
2. ORGANIZING information to handling contacts
outsiders on involving
organization's transmission of
● Assembling and coordinating the human, financial,
plans, policies, information to
physical, informational, and other resources needed actions, and outsiders
to achieve goals results: serves as
● Attracting people, specifying job responsibilities, expert on
grouping jobs into work units, marshaling and organization's
allocating resources, creating conditions so people industry
and things work together
DECISIONAL ROLES
3. LEADING/DIRECTING
ROLE DESCRIPTION EXAMPLES
● Stimulating people to be high performers
Entrepreneur Searches Strategy and
● Motivating and communicating with employees;
organization and review sessions
individually and in groups its environment for involving initiation
opportunities and or design of
4. CONTROLLING initiates projects improvement
● Monitors performance and implements necessary to bring about projects
changes change
● Makes sure that:
Disturbance Responsible for Strategy and
○ Resources are being used properly
handler corrective action review sessions
○ Organization is meeting its goals, e.g. when organization involving
quality and worker safety faces important, disturbances and
unexpected crises
MANAGERS SHOULD DEVOTE ADEQUATE ATTENTION disturbances
AND RESOURCES TO ALL FOUR FUNCTIONS.
Resource Making or Scheduling;
allocator approving requests for
MANAGEMENT ROLES
significant authorization;
● Decisional organizational budgeting. the
● Informational decisions programming of
● Interpersonal subordinates work

Negotiator Responsible for Contract

representing the negotiation

Made by Miguel Astronomo and Joshua Kintanar 1

 ● Vision: St. Luke's Medical Center will be an
organization at
major negotiations internationally recognized academic medical center
by the year 2020
● M: We are committed to deliver state of the art
INTERPERSONAL ROLES healthcare because at St. Luke's Medical Center,
the needs of our patients come first.
ROLE DESCRIPTION EXAMPLES
SWOT ANALYSIS
Figurehead Symbolic head; Ceremonies,
STRENGTHS WEAKNESSES
required to status requests,
perform a number solicitations
of routine duties of Characteristics of a Characteristics of a
a legal or social business which give it business which make it
nature advantages over its disadvantageous relative to
competitors competitors
Leader Responsible for Virtually all
the motivation and managerial OPPORTUNITIES THREATS
direction of activities Involving
subordinates subordinates. Elements in a company's Elements in the external
external environment that environment that could
Liaison Maintalns a Acknowledgment allow it to formulate and endanger the integrity and
network of outside of mall, implement strategies to profitability of the business
contacts who external/board Increase profitability
provide favors and work
Information ORGANIZATIONAL CHART
Depicts the arrangement of positions in the organization
WHAT IS MANAGEMENT PLANNING? ● Common purpose: unification of all members
○ Solid lines: Who reports to whom?
● Conscious, systematic process of deciding what
○ Boxes with titles: different clusters of
goals and activities the organization will pursue in
jobs/departments
the future
● Differentiation: many units that work on different
● Provides units with a flexible map to follow
tasks
● Integration: differentiated work is coordinated into
BASIC PLANNING PROCESS
an overall product
● Situational analysis: analyze the market and your
abilities
VERTICAL STRUCTURE
● Alternative goals and plans: include contingency
● AUTHORITY: legitimate right inherent to positions
plans
(e.g. make decisions, give orders)
● Goal and plan evaluation: advantages and
● RESPONSIBILITY: obligation to perform tasks
disadvantages
● SPAN OF CONTROL: number of subordinates who
● Goal and plan selection: select the BEST
report directly to an executive or supervisor (Ideal:
● Implement, monitor, and control
5)
● DELEGATION: assignin a task to someone at a
LEVELS OF PLANNING
lower level
STRATEGIC PLANNING (3-7 years)
● DECENTRALIZATION: more decisions are made at
● Making decisions about the long-term goals and
lower levels
strategies of the organization
HORIZONTAL STRUCTURE
● Departmentalization
TACTICAL PLANNING (1-2 years)
○ Groupings into departments
● Translating broad strategic goals into specific goals
○ Different functions and skills
and plans relevant to a particular unit in the
○ Division of labor
organization

OPERATIONAL PLANNING (<1 year)

● Identifies the specific procedures and processes
required at lower levels of the organization

MISSION AND VISION

MISSION: basic purpose of the organization

VISION: what do we want to become?

● Perspective on where the organization is headed
and what it can become

EXAMPLE
Saint Luke's Medical Center

Made by Miguel Astronomo and Joshua Kintanar 2

 LABORATORY MANAGEMENT

PRELIMS TOPIC 5. MATERIALS MANAGEMENT

Lecturer/s: Ms. Regine Morados, RMT, Mrs. Lorraine Mission-Maravilla, RMT
FULL TRANSES MASTERLIST: https://bit.ly/masterli_st

MATERIALS MANAGEMENT CONSIDERATIONS IN PURCHASING

● Management of the flow of materials into an
● Understand an local or national government
organization to be converted into the
requirements that need to be accommodated in the
organization’s end products
contracts
● Negotiate for the best price without undermining
FOCUS OF MATERIALS MANAGEMENT quality
● To acquire the right materials in the right quantity, of ● Carefully review all contracts to make sure the
the right quality, at the right time, from the right laboratory's requirements are being met (payment
sources, at the right prices. mechanisms, assurance of reliable availability and
delivery of reagents and supplies, penalties for
LABORATORY PERSPECTIVE ending a contract)
● Efficient and cost-effective laboratory operations
need the uninterrupted availability of reagents, INVENTORY MANAGEMENT PROGRAM
supplies, and services. ● Assign responsibility
○ Inability to test, even for a short time, is ● Analyze the needs of the laboratory
very disruptive to clinical care, prevention ● Establish the minimum stock needed for an
activities, and public health programs. appropriate time period
BENEFITS ● Develop needed forms and logs
● Establish a system for receiving, inspecting and
● Careful management of inventory helps to prevent
storing supplies
waste, which can occur if reagents and supplies are
● Maintain an inventory system in all storage areas,
stored improperly, or if reagents become outdated
and for all reagents and supplies used in the
before they can be used.
laboratory

CHALLENGE IN THE LABORATORY

COMPUTERIZED INVENTORY
● Balancing the availability of supplies and reagents
● keeps track of the exact number of supplies and
in stock with their expiration dates
reagents on hand, as it can be updated daily
○ WARNING: However, it is too costly and
● allows for good management of expiration
wasteful to overstock.
dates--the system can be set up to alert when lot
numbers are near the expiration date, and therefore
COMPONENTS IN MATERIALS MANAGEMENT use of resources can be optimized
● Vendor/manufacturer qualifications ● generates statistics that will help when planning and
● purchase agreements making purchases
● Receiving, inspecting, testing, storing, and handling ● helps manage the process for distributing reagents
of materials to satellite laboratories
● Tracking materials to individual patients ● eases the burden of inventory management
● assessing and maintaining inventory
● controlling expiration periods ANALYZING THE NEEDS OF THE LABORATORY
● dispatching supplies to satellite laboratories
● a complete description of each item used (e.g. size
of syringe)
SELECTING VENDORS ● the package count or number of units in which the
● define criteria for supplies or materials to be item is supplied (e.g. pipette tips can be packaged
purchased as 100 per box or 1000 per box)
● look for the best price, considering the qualifications ● approximate usage per month (quantification, e.g. 6
and credibility of the supplier boxes used per month
● consider the advantages and disadvantages of ● the priority or importance level the item has in doing
purchasing "brand name" compared to "generic" the work of the laboratory (e.g. used every day or
products only once a month?)
● length of time required to receive a delivery (Will the
order take a day, week or month to arrive?)
● storage space and conditions (Will a bulk order use
too much storage space? Does the item require
storage in a refrigerator?)

Made by Miguel Astronomo 1

 HOW TO ORDER? prevent movement shifts or falls. Shelves should be
attached firmly to support walls to prevent tipping.
● Quantification is a very important process that can
● Ensure items are accessible to staff. Sturdy step
help calculate how much is required of any item for
stools should be available for reaching higher
a given period
shelves and heavier items should be stored on
lower shelves; laboratory staff should not be
TYPES OF QUANTIFICATION
required to lift heavy items.
● Consumption-based quantification
● When storing, put the new shipment behind existing
○ based on experience over time
materials that are already in the laboratory.
○ based on actual consumption
Organize the reagents and materials so that the
○ For example, to determine the actual
older materials get used first (i.e. items with the first
usage, it is important to also estimate how
expiry dates are the first used): first in, first out rule.
much wastage has occurred and how
● Labelling shelves is a useful tool for storing
many expired or spoiled reagents and
inventory and will help to systemize and organize
supplies have been discarded
storage space.
○ Assign a number (or name) to different
● Morbidity-based quantification
areas of the shelves.
○ Based on the actual number of episodes,
○ Record in the logbook what shelves are
illnesses and health problems that require
used for which reagents and supplies
laboratory testing.
○ In other words, the laboratory needs to
estimate an expected frequency of the
disease in question- how many cases will
occur per unit of population (per 1000, per
10 000, etc.)? Then, considering how
many people the laboratory serves, it can
estimate the total number of cases the
community might reasonably expect to
observe.

FORMS AND LOGS

● 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 LOG

● 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 degrees C freezer, to media
room)

STORAGE OF SUPPLIES
● Keep the storeroom clean, organized and locked to
protect the inventory
● Make sure storage areas are well ventilated and
protected from direct sunlight
● Ensure storage conditions are in accordance with
the manufacturer's instructions, paying particular
attention to any temperature requirements or other
specifications, such as safety requirements
● Use good shelving strong enough to support items
and organize items carefully on the shelves to

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 1 | HUMAN RESOURCE MANAGEMENT

● Ensures accurate lab testing by personally drawing specimen

HUMAN RESOURCE MANAGEMENT from patients and/or by giving clear, precise instructions to
● Deals with formal systems for managing people at work patients for self-administered lab tests.
○ how to manage manpower, how to hire/recruit, and ○ Skills of obtaining specimen
control people in the institution/business ● Enhances the efficiency and accuracy of lab testing by
○ Focuses on managing manpower — process of hiring, maintaining adequate laboratory supplies, by keeping
promoting, and removing people that are not beneficial equipment in operational condition and by maintaining a clean
to the company and orderly laboratory work area.
● Demand forecasts: how many and what types of people are ○ Timeliness and orderliness
needed ○ Cleanliness when working
○ what are the positions needed in the company, ○ Maintaining the inventory
example: how many attending staffs do we need in ● Assists in preparation of monthly statistical reports by keeping
the institution accurate records on all laboratory procedures performed
○ Hire people that are important in the efficiency of the ○ Logbooks recording, keeping of data, and reporting of
company statistical reports
○ How many and what types of people are needed to ● Maintains quality assurance of the laboratory by performing
reach the goal? proficiency testing.
● Labor supply forecasts: how many and what types of people ○ Able to compete with other labs
are available
○ How many applicants are interested in the job? How SAMPLE JOB SPECIFICATION OF A MEDICAL TECHNOLOGIST
many applicants are qualified for the job? ● A Degree in Bachelor of Science in Medical Technology
○ How many people are applying for the job? ● Professional License from Professional Regulatory
○ How many professionals are reaching throughout your Commission
application for the job? ● Note: Some labs may specify that you should be living or must
○ Depends on how you cater or market the company to be willing to work in a certain area
the people for them to be persuaded to apply ○ Relocation
● Reconciling supply and demand ● For higher positions like section head or chief medical
○ Checking the trend, beneficial personnel, and technologists, additional specifications may be required:
compensations needed in order to get supply ○ Years of experience
○ Determining the demand you are trying to offer to ○ Necessary training/s
people in order to persuade them to work with you ■ DOH training
■ DSSM training
JOB DESCRIPTION JOB SPECIFICATION ■ HIV Proficiency training
■ *Advantage for higher position
● summary of what an ● statement showing what
○ Advance education
employee will do after a person must possess
getting selected for getting selected
● based on what you will do ● based on your RECRUITMENT
once you're officially hired credentials, training, ● INTERNAL: from existing employees (e.g. Promotion or
in the institution. seminars, and the relocation of one employee to another department or branch)
● Examples: academic degree that you ○ Promotions can encourage employees - it allows the
○ Able to perform earned. employee to gain more compensation and incentives
phlebotomy, that makes him productive to his/her work.
and specimen 1. Behavior, traits, and ● EXTERNAL: can inspire innovation (by recruiting applicants to
collection with attitude join for the workforce)
minimal or no a. Able to work ○ Internet: company websites, job boards
supervision. under pressure ○ Employee referrals, newspapers, job fairs
○ Run machines b. Able to ○ Word-of-mouth
○ Disinfect the multitask
area 2. Credentials SELECTION
● Anything that is beyond a. Graduate of ● Applications/resumé provide background information
the job description is BSMT ○ Curriculum vitae (Overall background of yourself)
subjective to discretion b. ASCP License ■ Credentials
○ If the load is not c. Masters Degree ■ Work experience
heavy, everyone ● Interviews
can still ○ Structured: same question/s per applicant
perform the job ■ Lacks genuity
● However, if the ordered ○ Unstructured
work is overly beyond the ■ More on the personality and relatability of
job description itself, a the applicant
compensation should be ○ Classified into Initial and Final interview
given ■ Initial: HR manager or director
○ Not allowed to ● Background check
perform work ● Proficiency
that is not in ● IQ tests
line with the job ● Others
description ■ Final
without ● Personality check
compensation ○ Tell what you can bring
out to the table
SAMPLE JOB DESCRIPTION OF A MEDICAL TECHNOLOGIST ● Difficult part
● Assists the clinic physician in making a medical diagnosis by ○ Choosing the best candidate for the job
accurately performing and reporting all in-house laboratory
testing procedures and obtaining necessary specimens for REFERENCE CHECKS
reference laboratory testing, as required. ● Contact references
○ Perform accurately and report the results correctly — ○ Number and work designation
no room for error ● Former employers/schools

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 1 | HUMAN RESOURCE MANAGEMENT

○ Dean ○ at least 5 days with 8 hours work schedule

○ Co-workers ● part-time (8-32 hours a week)
○ Clinical instructors ○ can work into different institutions as long as there's
○ Teacher no conflict of interest
○ *To know the character and background of the ● per diem (reliever/on-call)
employee ○ called when there's an emergency or problem with
the number of staff duty for that day.
TRAINING ○ Filler/floater
● Teaching lower-level employees how to perform the job ■ Function: fill the schedule gap
○ Allowing to familiarize the employees with the job ● Considerations when making the lab schedule: personal
● Goal: familiarize new employees with the job, the work units, requests, official business, religion (SDA)
and the organization in general ○ Personal requests - all staffs can requests for their
● Start with the basics prior to the sophisticated part of the availability dates except for office-based work
training ■ Done 3 days or 1 week prior
○ Washing of tubes ○ Official business - if they have seminars and trainings
○ Run samples to be attended,
○ Phlebotomy ■ If you asked to duty despite having official
■ Extracting blood business, you can ask for a
replacement/reliever
DEVELOPMENT
■ Official business = must not work
● Managers/professional employees gain needed broader skills ○ Religion (SDA)
● Sending them to trainings, seminars, workshops ○ Sick leave
○ Received a certificate after the seminar ○ Vacation leave
○ Advantage compared to other co workers: ○ Birthday leave
■ Allowed to check and sign samples
■ Ex. HIV proficiency
TWO COMMON SCHEDULE FORMATS
● Limited MT personnel are allowed
to verify the test
● Person who received training and 8/80 WORK RULE 40-HOUR WORK WEEK
has a certificate for evidence is
allowed to check
● 1 day: 3 8-hour work ● shift: any number of
● Allows you to enhance yourself by developing your skills into
shifts hours
another level.
● shorter shifts, more ● Longer shifts, less days
■ Ex. Masters degree
days of duty of duty
■ Companies prefer to hire people who have a
graduate school background
● As per DOLE DO 128 ● 40 hour week sched
● Increased possibility of attaining higher position
series of 2017 allows ● Ex. 4 days = 10 hours
for 96 hours, 15 days each is allowed, as long
ASSESSMENT OF JOB PERFORMANCE work per individual as you completed the 40
● WHAT? (what are the factors that we need to assess) ● 8/80 hours - you are hours
○ Traits: numerical scale (1-5); ambiguous and working for 8 hours, no ● More off days, but
subjective since the perception of one employee is extension prolonged work
different from the others ● Applies to workplaces hours/sched
■ Survey form that have a lot people ● In 15 days, it is possible
■ Assess through statistical methods ○ Toxic to have 5-6 days off
■ Evaluate percentage in that particular scale workplace ● You can collate the off
● Tardiness, etc. ○ Requires days
● ex. I am sleeping when I dont strong ● Ex. 1-5 = duty; 6-11 = no
have job = 2 workforce if duty (off days; allowed
○ Summed up and a lot of for vacation; no violation
converted to patients and no need to file for
percentage come in leave since it is
○ Behavior (what is the work ethic of the employee? ● Required to go to work considered as a
How the employee makes communication with everyday requested day off)
his/her co-workers?) ● For heavy workload ● You can maximize your
■ Performance ● 3 days off time
■ Evaluation ● More applicable to less
■ How you treat others (team player) toxic workplaces
■ Knowledge ● Can survive the duty
○ Results: production data (basis for the management despite short staffed;
to remove or retain the employee) less workload
■ Overall score after the assessment
● Excellent
● Good STAFFING PATTERN FOR RMT ANALYSIS
● Needs improvement
● WHO? Staffing Pattern for RMT Analysis
○ 360-degree appraisal for fuller picture of strengths
and weaknesses 1. Clinical Laboratory for Clinical and Anatomic Pathology
■ Strengths and weaknesses are assessed by
the HR
○ Subordinates, peers, outsiders, superiors
■ Identify areas for improvement

SCHEDULING
● assigning employees to work-specific hours, departments, or
tasks
● full-time (40 hours a week)

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 1 | HUMAN RESOURCE MANAGEMENT

2. Clinical Laboratory for Anatomic Pathology proficient, DSSM training, PC tests, Blood Borne disease
● At least one RMT per section seminar.
3. Clinical Laboratory for Molecular Pathology ○ Best choice
● Will depend on the services offered ■ More competent and credible
■ Has advanced learning
■ More flexible

● Morning shift and afternoon

○ Requires lot of employees
■ All OPDs, other people that want to get
checked, annual physical checkups
● More work force during toxic hours, more efficient

SAMPLE PROBLEMS

● Medtech I: 10 years experience, MAsT-Biology degree

holder, with a lot of work proficiency tests and seminars
attended including Quality Assurance Seminars and
Workshops. HIV proficient, DSSM training, PCR tests
○ Best choice
■ Advantage: trained, few trainings are
required for the proficiency of his career
■ Years of experience
■ Attended a lot trainings and seminars
● More qualified for the job
specification
● Medtech 2: 7 years experience, MSMT holder, not so many
compared to medtech 1 but he became class valedictorian
of a prestigious medical school. Had attended QA seminars
and workshop but trainings is quite less than medtech I.
○ Lack training which is essential
○ Companies don't want to waste money for training
○ Choose trained/qualified individuals for the
position

● Medtech I: 20 years experience, RMt and ASCi holder, with a

lot of work ° proficiency tests and seminars attended
including Quality Assurance Seminars and Workshops.
○ No career development

● Medtech 2: 5 years experience, MSMT holder, not so many

compared to medtech 1 but he became class valedictorian
of a prestigious medical school. Training includes HIV

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 2 | LABOR RELATIONS AND STANDARDS

Exam sample question: ■ Not exceed 8 hours a day, and 40 hours a

1. You are the newly promoted HR manager in the Saoyao's week
Diagnostics. Your previous position is vacant and you need to ■ How many hours does a health worker
find another Chief Medical Technologist in the laboratory should work per cut off?
section. You want to assure that Saoyao's Diagnostics will run ● 2 cut offs per month
above the expectation like what you've done for the last 5 ● 15 days = 1 cut off
years. Which of the following applicants is the fit to be the next ○ 40 hours x 15 days =
MT of your laboratory? 96 hours
■ There should
MedTech 1: RMT with MSMT degree and three years of experience as a be at least
Quality Control of YVZ laboratory. Attended seminars and trainings 12 days = 8
include Quality Assurance, Molecular Diagnostics, Water Microbiology, hours
and HIV proficiency. ○ It is possible to request
for a 12 hour- shift to
MedTech 2: RMT with MAST-Biology degree and 8 years of experience complete the 96 hours
as a Laboratory Supervisor in AAB laboratory. Attended seminars and duty = 8 days duty
trainings include HIV proficiency, Biosafety and Biosecurity ○ 96 hours/12 hours = 8
Management, Double Smear Sputum Microscopy, and Quality days duty
Assurance. ○ 16/31 = cut off is still
at the 15th day →
Medtech 3: RMT with ASCPi license and 15 years of experience as a head 15/30 (addtl 1 day)
of the laboratory in an RHU hospital. Attended seminars and trainings
include Biosafety and Biosecurity Management, DSSM, HIVProficiency, ● Rest period of short duration: counted as hours worked (coffee
Quality Assurance, and 2-successive certification for NEQAS and EQAS break, meal period < 1 hour)
○ 8 days
● Cancel MedTech 1 ■ Maximum “break” days under a 4- hour work
○ 3 years of experience only week
● Cancel MedTech 3 ○ In a 16/31 → you are allowed to not work for 8 days,
○ More experienced but outdated then work for 8 days = 16 days
■ Did not climb to higher education with ○ You are allowed to request for 5-6 days straight no
his/her 15 years of experience duty
● Choose MedTech 2 ○ During “day offs” → not allowed to be disturbed by
○ Priority: Check the honorarium/degree your employers
■ Master’s Degree ■ Day offs = paid
● Advantageous ○ Meal breaks, rest breaks
● First qualification to be a CMT ■ Done less than an hour of your duty
■ Office setting = has 1 hour allotted to have a
LABOR RELATIONS AND STANDARDS break
■ Health workers must work for 8 hours
straight; no break
EMPLOYER-EMPLOYEE RELATIONSHIP
● “Break” = not reach for an 1 hour
● Four-fold test (subjective)
○ The hired employee is entitled for a four-fold test ● Some employees/companies
● Selection and engagement of the workers area allowed to have >1 hr breaks
○ Includes the training, equipment and application (for institutions w lesser
● Payment of wages workload)
○ Salaries, incentives, benefits, and other kinds of “pays”
(i.e. overtime, night differential, etc.)
Additional Info: (DO 182 series of 2017)
■ Night shift = more pay compared to day
shift ● Health personnel in cities and municipalities with a population
● Power of dismissal of at least one million (1,000,000) or in hospitals and clinics
○ Power to terminate or remove an employee based on with a bed capacity of at least one hundred (100) shall hold
violations against code of conduct regular work hours for eight (8) hours a day, for five (5) days a
● Power to control the workers' conduct week, exclusive of time for meals, except where the exigencies
○ Power to create rules and regulations to exercise your of the service require that such personnel work for six (6) days
authority in order for your employees to maintain their or forty-eight (48) hours, in which case, they shall be entitled to
composure as head of the organization an additional compensation of at least thirty percent (30%) of
● Refers to existence of power and not necessarily to the actual their regular wage for work on the sixth day.
exercise thereof ○ Exigency = existing emergency
■ Ex. terrorist attack, pandemic, backlogs, fire
emergencies
HOURS OF WORK
● Need workforce
● All time during which an employee is required to be on duty or ● Last day = 6 hours a week, 6th
to be at the prescribed workplace day multiplied by 1.3; salary =
○ Ex. duty is at 8am-5 pm 1000 day
■ Enter the workplace before 8 am, then end
your shift at 5 pm
● General Rule: 8 hours a day for 6 days a week ● Exigency Formula: salary per day x 1.3
○ = 40 working hours; 1 day off ○ 1000 x 1.3 = 1,300 (compensation)
● Exception: Health personnel who hold regular office hours for 8
hours a day for 5 days a week
○ 1 hour will be allotted for their meal break NIGHT SHIFT DIFFERENTIAL
● The normal hours of work of any public health worker shall not ● At least 10% of regular wage for each hour of work between
exceed eight (8) hours a day or forty (40) hours a week. 10:00 pm to 6:00 am
○ DOLE Department Order 182 series of 2017 ○ 10% of your hour
■ States that health workers or any worker ○ Ex. duty for 10pm-6am → will have at least 10% night
should work for at least 8 hours a day, for 5 shift differential
days a week ■ Institutionalized → depends per company
■ Ex. 1000 a day (8 hours duty)

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 2 | LABOR RELATIONS AND STANDARDS

● Completion of work is necessary to prevent serious business

loss
● 1 NSD = Daily wage + daily wage x 0.1 x # of hours ○ Need for inventory
○ 1000 x 1000 x 0.1 x 8 = ○ For backlogs → do overtime
○ 1000 + 800 = 1800 salary
■ Total wage = 1800
MEAL BREAK
■ ND = 800
● Not less than 60 minutes time-off for regular meals
○ The meal breaks depends upon the institution
○ Why do we give a night differential? ■ Not heavy workload → can meal break
■ Night shift is more health risky compared to anytime
day shift ● The 8-hour work period does not include the meal break
■ Night shift is more prone to disease ● May be taken outside company premises

OVERTIME WORK REST DAY

● Work performed beyond 8 hours a day ● Duty of employer: 24 hours rest period after every 6
● Additional compensation consecutive normal workdays
● Regular day: no. of hours in excess of 8 hours (125% * hourly ■ Based on the DOLE Department Order 182
rate)
○ Overtime rate is institutionalized Exigenboyant nase
○
■
series of 2017
24-48 hours
Employer shall respect the preference of employees
x7 as to their weekly rest day when such preference is
● Overtime > 8 hours (+) perday 3 based on religious grounds
.

= Salary
● Overtime formula: hourly rate x 1.25 x # overtime hours Exigengy daily wage X0 1y ■
wage
.

SDA Adventist
● 8 hour duty = 1000 ND Daily
:
hours ● Have the right to ask permission
#
○ 125 per hour not to duty during saturdays
● Ex. instead of 6-2, you worked for 6-6 (overtime: 4 hours) x 1 28
rate
Hourly
.

■ Rest days depend on how many hours you

Overtime: 125 x 1.25 x 4 = 625 (additional overtime Overtime hours
=

○ over time need to render

pay) ● Ex. 96 hours → rendered within 8
● Ex. 2-10 Dan duty, 6-2 Johnny duty → Johnny overtime = 6-10 Kate X 1
3
days
Holiday : Daily
.

= 8 hours overtime
○ Hour: 125 x 1.25 x 8 = 1250 special Holiday
: Daily Rate x ○
○
Worked for 12 hours
Day off = 6-7 days
Regular
: (Months stay) (salary
of ■ You can
What is the total wage the employee gained for that particular Pro-Rate control when
week?
cimonth) to have your
day offs
● Daily wage: 1000 per day ■ Can do 6
● Night differential: 0.1 consecutive
● Overtime pay: 125 day offs
● Total of hours: 44 hours ■ Vacation
○ 4 hours overtime leave = paid
● 1 week salary = 6850 incentive
■ Day offs →
Monday = OFF no deduction
in salary
Tuesday (6am-2pm) = 1000
HOLIDAY PAY
Wednesday (6am-10pm) = 2000 ● Work on special holiday: (daily rate * 130%)
○ Approved holidays by the government or the president
■ Ex. Kadayawan, Black Saturday, Ninoy
Thursday = OFF
Aquino Day, Araw ng Davao
■ Localized holidays

specat Xo
Friday (6pm-6am) = 2425 ● Work on regular holiday: (daily rate * 200%)
● Regular wage: 1000 ○ Declared holidays
● Night differential: 8 hours = 800 ■ Double pay
● Overtime: 625 ● Ex. daily rate: 1000 → will receive
2000 during declared holidays
Saturday (10pm-6am) = 1800
WHAT ARE THE REGULAR HOLIDAYS?
Sunday = OFF ● Provided by RA 9849:
○ New Year
● Holiday or rest day: no. of hours in excess of 8 hours (130% * ○ Maundy Thursday and Good Friday
hourly rate) ○ Araw ng Kagitingan
○ If the employee worked for extra hours (i.e 4 hours) ○ Labor Day
during his day off = overtime ○ lndependence Day
○ National Heroes Day
○ Bonifacio Day
COMPULSORY OVERTIME WORK
○ Eid'| Fitr
● If the country is at war or when there is a declaration of national
○ Eid'I Adha
or local emergency
○ Christmas Day
○ exigency
○ Rizal Day
● To prevent loss of life or property, or in case of imminent
● Exam question: All are regular holidays except?
danger to public safety caused by accidents, fire, floods,
○ New year, National Heroes Day, Ninoy Aquino Day,
typhoons, epidemic, or other disaster or calamities
Labor Day
● When there is urgent work to be performed on machines,
■ Shade 3 → choose all that apply
installations, or equipment to avoid serious loss or damage
● To prevent loss or damage to perishable goods
13th MONTH PAY

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 2 | LABOR RELATIONS AND STANDARDS

● PD 851: 1/12 of an employee's basic annual salary ○ 7 days with full pay for the first 4 deliveries (or any
○ One month basic salary (overtime is not included) miscarriage) of the legal spouse with whom he is
○ Given during December cohabiting
○ Ex. 20,000 salary in a month = 20,000 13th month pay ■ If not wed, can the employee file for a
● May be given in 2 installments (May and December) paternity leave? YES
● As long he is the recognized
● 13 month = (mos of stay/12)(salary per month) father of the child
● Ex. Employee was hired in June → are you entitled for a 13th ■ Court ruling: paternity leave is allowed if the
month pay? YES father fully recognizes that he is the father
○ (6 months/12)(20,000 salary) = 10,000 of child to the significant other
■ Pro-rate (non-spouse)
● Wasn’t able to reach a full year, ● As long as there is an agreement
but you were able to receive 13th that the mother recognizes the
month pay father as a parent to the child
● Given during resignation
● Ex. worked during jan-june → SECURITY OF TENURE
resign during june = still entitled ● "A regular employee shall remain employed unless his or her
to receive 13th month pay services are terminated for just or authorized cause and after
(pro-rate) observance of procedural due process."
■ Pro-rate formula: (months of ○ Other term: Plantirya position
stay/12)(salary) ■ An already secured position
■ 13th month pay ■ If the company needs to remove employees,
● Applicable when the employee you are able to stay since you have the
was able to receive the full 1-yr security of tenure
13 month incentive ■ If the company removed you without any
● Ex. 20,000 salary in a month = valid reason despite having the security of
20,000 13th month pay tenure → you can file for a case
● 14th month ■ Must undergo procedural due process
○ Other companies employ 14th month pay before termination
■ Ex. Employee already worked for a year =
entitled for a 14th month pay
TERMINATION OF EMPLOYMENT
● Only provided for employees who
worked for years ● Balancing of interests in disciplinary cases
○ Same salary → usually given during May and ○ Labor's interests: right to labor and due process
December ○ Management's interests: promulgation of rules and
○ December = 13th moth regulations and enforce and implement them for
○ May = 14th month efficient business operations
● Christmas Bonus ■ Termination may be due to bankruptcy, the
○ Incentive provided by the company employee made a mistake, or the
○ Institutionalized; company basis management decides to terminate the
■ Company A: no christmas bonus employee due to performance.
● Employees can’t complain to the ● May be due to:
company for not having ○ JUST CAUSES: act or omission by the employee
christmas bonus ■ The action is committed by the employee
■ Company B: have christmas bonus ○ AUTHORIZED CAUSES: exercise of management's
prerogative
■ The management decided for your
FORMS OF PAYMENT
termination
● "No employer shall pay the wages of an employee by means of ● Twin requirements
promissory notes, vouchers, coupons, tokens, tickets, chits or ○ Due process
any object other than legal tender, even when expressly ■ Process that enables the management to
requested by the employee." investigate the matter, esp. the perpetrator
○ Forms of payment: money, checks, paper bills, or and the victim or the management and the
electronic accounts offender to determine the truth
○ Use of voucher and the like = illegal ○ Valid cause
○ Ex. received salary → bank → bank can’t receive the ■ Without these two, the dismissal is illegal
check since the check contains no value/money ● Example: the employee is good in
■ The employee will complain the employer, laboratory work, however he
what is the law that can be used to support tends to gossip a lot = neglected
the employee in this situation? RA 7677 his work → the management
(Bouncing Check Law) decided to terminate the
● Google: Batas Pambansa Bilang employee
22 (Anti-Bouncing Check Law) ● Therefore, it is a valid cause to
terminate the employee because
MATERNITY/PATERNITY LEAVE he is consistently absent from his
● In service for at least 6 months post
● RA 11210: 105 days leave with pay + an option to extend for 30 ■ Valid to terminate immediately when caught
days without pay (single parent: additional 15 days with pay) in the act
■ Miscarriage or emergency termination of
pregnancy: 60 days (w pay) JUST CAUSES
○ Total of 130 days of leave ● SERIOUS MISCONDUCT
■ Before: total of 90 days leave → was ○ Serious; related to performance of duties; must show
amended to almost 130 days of leave that the employee has become unfit to continue
○ Exam question: What section of the RA 11210 that working for the employer
states the maternity leave must be 105 days leave ○ Examples:
with pay + an option to extend for 30 days without ■ Falsification of time records
pay? ● Tampering of time records =
● Paternity leave (RA 8187) serious offense

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 2 | LABOR RELATIONS AND STANDARDS

■ Moonlighting ○ “The employer has no legal obligation to keep in its

● Act of working an extra job, payroll more employees than are necessary for the
without telling the main employer operation of its business” (Wiltshire File Co. V. NLRC)
→ Conflict of Interest ■ Subjective = some employers might allow
● There shall not be 2 employers at this with agreement of the employee
the same time when there is ○ To give space to new employees
conflict of interest ○ Requisites for a valid redundancy program
● Part-time job → make sure the ■ 1 month written notice to employees and
employer knows about it DOLE
■ Theft of company property ■ Separation pay (1 month per year of
● To get without notice service)
■ Fighting within company premises ■ Good faith in abolishing redundant
● Destroy or tarnish the reputation positions
of the workplace ■ Fair and reasonable criteria in ascertaining
redundant positions: efficiency, seniority,
● WILLFUL DISOBEDIENCE/INSUBORDINATION less preferred status
○ Willful/intentional; characterized by a “wrongful or
perverse attitude”; order violated must be ● RETRENCHMENT
reasonable, lawful, and made known to the ○ Layoff - dismissing employees that are not regular
employee; must pertain to the duties he had been ○ dismissing employees to avoid or minimize losses
engaged to discharge (must be done BEFORE the losses anticipated are
○ Willful disobedience = intentional actually sustained)
○ Can employees refuse to comply with company rules ■ Not because of the behavior or attitude, but
and regulations by challenging their reasonableness? because of the company itself
■ “NO. It is impermissible to suspend ○ Requirements for valid retrenchment
enforcement of the orders or rules until ■ Done to prevent business losses
their legality or propriety shall have been ■ Written notice to employees and DOLE at
the subject of negotiation, conciliation, or least 1 month prior to the intended date of
arbitration” (GTE Directories Corp v. retrenchment
Sanchez) ■ Separation pay to employees
■ Done in good faith
● GROSS NEGLIGENCE AND HABITUAL NEGLECT OF DUTIES ■ Fair and reasonable criteria to ascertain
○ GN: absence of care in the performance of duties who would be dismissed
○ HND: repeated failure to perform one's duties
■ Must not only be gross but habitual; a ● CLOSURE OF THE COMPANY
single isolated act is not habitual (National ○ May be partial or total
Bookstore v. CA) ■ What if the employer will sign for
○ Examples: bankruptcy in order to save the company?
■ Absenteeism (requires warnings) ● Type of Closure: Partial
● AWOL (absent without leave) ○ Capacity is not enough
■ Abandonment of work to pay
■ Tardiness ○ Not always bankrupt; may be a violation
■ Such as illegal recruitment
● FRAUD AND LOSS OF TRUST AND CONFIDENCE ○ In good faith
○ Employee holds a position of trust and confidence; ○ 1 month written notice to employees and DOLE
there must be an act that would justify the loss of ○ Separation pay needed, except in cases of serious
trust and confidence business losses
○ Positions of trust
■ Managerial employees ● DISEASE OR ILLNESS
■ Cashiers, auditors, property custodians, ○ Continued employment is prohibited by law or
etc. handling money or property prejudicial to his health or the health of his
co-employees
● COMMISSION OF A CRIME OR OFFENSE BY THE EMPLOYEE ■ Employee itself is not capable anymore to
AGAINST THE PERSON OF HIS EMPLOYER OR IMMEDIATE work because of the seriousness of the
MEMBER OF HIS FAMILY OR DULY AUTHORIZED disease
REPRESENTATIVE ○ Medical certificate NEEDED: disease can't be cured
○ “Conviction of an employee in a criminal case is not within 6 months even with proper medical treatment
indispensable to warrant his dismissal” (Mercury ○ 1 month written notice to employee and DOLE
Drug v. NLRC) ○ Separation pay
○ Sometimes the employer does not suggest
● OTHER ANALOGOUS CAUSES termination
○ Attitude problem ■ In order to return to work, the employer will
■ “Without the necessary teamwork and suggest resignation
synergy, the organization cannot function
well” (Heavylift Manila v. CA) OTHER CAUSES OF TERMINATION
■ Could be subjective ● Failure of the probationary employee to qualify as a regular
○ Grave Offenses employee
■ Sexual Harassment ● Totality of infractions doctrine
■ Murder
■ Involved in terrorism PROCEDURAL DUE PROCESS
● Notice of appraisal: specifying the grounds of termination
AUTHORIZED CAUSES giving time to employee to rebut
● REDUNDANCY ○ 10-15 days to reply
○ Services of an employee are in excess of what is ● Hearing or conference
reasonably demanded ● Notice of termination: after considering all circumstances
● What if there was no due process?
○ No due process

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERM | 2023-2024 | LESSON 2 | LABOR RELATIONS AND STANDARDS

○ Authorized causes: P 50,000 damages

○ Just causes: P 30,000 damages

QUESTIONING THE LEGALITY OF DISMISSAL

● Substantive grounds
○ Absence of a just or authorized cause supporting the
dismissal
● Procedural grounds
○ Failure of the employer to give the employee an
opportunity to explain his or her side
● THE EMPLOYER has the DUTY to prove the dismissal is valid

TERMINATION BY EMPLOYEE
● Written notice at least 1 month in advance
● No written notice:
○ Serious insult by the employer
○ Inhuman and unbearable treatment
○ Commission of a crime or offense by the employer
against the employee

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERMS | 2023-2024 | LESSON 3 | LEADERSHIP AND COMMUNICATION

■ You are motivated to work because there

LEADERSHIP AND COMMUNICATION are other factors that influence your
personal satisfaction
○ Extrinsic
DIMENSIONS OF LEADERSHIP
■ rewards linked to job performance (not
● Leadership quality sufficient in the long run)
○ some seem to be effortless at it while others have to ■ Pertains to the rewards
work at it ■ Example
○ Two types of leader ● Want to attend the MedTech
■ Naturally-born leader days/class due to the plus points
● Innate ● Motivated to join events in the
● Has a commanding MedTech week due to free food
aura/presence
● Has a trait that proves he is a
THEORIES ON MOTIVATION
leader
● Leadership is based on his/her
features THEORY PROPONENT
■ Leader based on experiences
● Can lead based on what he/she Hierarchy of needs Abraham Maslow
learned during practice
● Chief Medtechs are not naturally
ERG Theory Clayton Alderfer
born-leaders - they are
experienced
● Through experience, they are able Needs Theory David McClelland
to think and become a leader of
their own institution Two-factor Theory Frederick Herzberg
● Opportunity
○ chance to demonstrate leadership Goal-setting Theory Edwin Locke
■ Through delegation, you will be tested if
you're an effective leader or not Equity Theory John Stacey Adams
○ Time wherein you are able to perform your duty as a
leader
Expectancy Theory Victor Vroom
■ Ex. Prof assigned/delegated a task to a
student- provided a group task for the class
● Provided an opportunity to the
student to demonstrate his HIERARCHY OF NEEDS
leadership skills
● If the students did not comply to
his commanding - he failed as a
leader
● If the students complied to his
command and accomplished the
goals - he is an effective leader
● Context
○ the benefit of a favorable context is always a PLUS
● Foundation: TRUST; Bottom Line: INFLUENCE
○ Trust
■ Leader must be trust-worthy in all the works
■ He must show his members that he can be
a shoulder to lean on in times of trouble
■ People must trust you
○ Influence
■ How will he influence/motivate his
co-workers
● Price Tag of Leadership: Self-discipline
○ Good work-ethics, disciplined enough, good SELF-FULFILLMENT Self-actualization:
communication skills with the people around him = NEEDS - Achieving one’s full potential,
will prove him to be a good leader including creative activities

MOTIVATION PSYCHOLOGICAL Esteem needs:

● The process of stimulating people to actions to accomplish the NEEDS - Prestige and feeling of
goals accomplishment
○ Stimulates people to do more/good when it comes to
a particular work Belongingness and love needs:
○ Motivation has a good and bad side - Intimate relationships, friends
■ Can motivate you in positive/negative ways
● Two types:
BASIC NEEDS Safety Needs:
○ Intrinsic
- Security, safety
■ personal satisfaction of the work itself
■ Examples
● You are satisfied because of the Physiological needs:
groupmates you have in an - Food, water, warmth, rest
activity
● You are motivated because you Maslow’s Theory
are with your crush ● states that our actions are motivated by certain physiological
● You are assigned with a pretty and psychological needs that progress from basic to complex
prof for research

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERMS | 2023-2024 | LESSON 3 | LEADERSHIP AND COMMUNICATION

A. Basic Needs ● Coworker relations

● Pertains to the survival/daily/basic needs to survive ● Policies and rules
B. Psychological Needs ● Supervisor quality
● Pertains to feelings that you want to express/can be ● Base wage, salary
developed
● Ex. Prestige - feeling of accomplishment GOAL-SETTING THEORY
○ You can gain self-esteem; confidence, pride ● Specific and challenging goals along with appropriate
C. Self-Fulfillment needs feedback contribute to higher and better task performance.
● Belongingness and love needs ○ Ex. The individual performed the task poorly = low
○ Pertains to intimate relationships, friends scores —> the prof suggested you to do a follow a
■ Close bond certain platform = improved over time
■ Mutual relationship ○ Feedback = tells you if you need to continue a certain
● Self-actualization thing of change
○ Top hierarchy ■ Goal: better results
○ Allows you to reach your own potential ○ Ex. If you perform blood smears and your boss tells
○ Pushed to the limits you to make it better next time, you are motivated to
perfect your work and show him that you are capable
ERG THEORY of doing the job.
● ERG = Existence, Relatedness, Growth ● Goals indicate and give direction to an employee about what
● Existence: material requirements for survival needs to be done and how much efforts are required to be put
○ Physiological and safety needs in.
● Relatedness/Relationships: people's desire for social support, ○ there must be a direct instruction and supervision
interpersonal relationships, and favorable recognition from your supervisor
○ Love and esteem related needs ○ Received a negative feedback
○ You are able to create connections with different ■ Must be exert more effort to go back to the
people right track
○ Grow and develop your talent ○ Feedback will drive you to finishh
● Growth: intrinsic desire to use and develop one's talents
○ Self-actualization EQUITY THEORY
● Similar to Abraham Maslow ● calls for a fair balance to be struck between an employee's
inputs (hard work, skill level, acceptance, enthusiasm, and so
McCLELLAND’S NEEDS on) and an employee's outputs (salary, benefits, intangibles
● Has positive and negative side such as recognition, and so on)
○ Negative side: ● Your motivation is based on the compensation provided
■ It it is done in the wrong way - you may ● Pertains to inputs and outputs
possibly cause manipulation ○ Ex. Employee is lazy due to low salary
■ McClelland’s Needs is more on the influence ○ Main point of the theory:
to other people by receiving social approval ■ Motivation = Compensation
■ Gaslighters, Power trips ● Good incentives —> individual will
○ Must only be for motivating people positively do his best to stay
● Achievement: drive to accomplish things ● Bad compensation =
○ Positive demotivated; can't focus and
○ Motivated to finish work
● Affiliation : desire to be liked by others and receive social ● Not well compensated = bad
approval and close interpersonal relationships performance
○ Become affiliated ● employees are not motivated, both in relation to their job and
○ Become a role model their employer, if they feel as though their inputs are greater
○ Gain social approval of the people than the outputs
● Power: desire to influence or control other people ● Example: if the salary is only 300 a day, you may only give
○ Motivating someone to do the same minimal effort to the task and vou will not finish it
○ Different people are motivated by different drivers, so
understanding what specifically motivates a person EXPECTANCY THEORY
to complete a task can vastly improve the likelihood ● The effort put forth on a task will be determined by the value
that they’ll complete the assignment and do it well the person places on the task and on the belief that he or she
○ Example: If your co-workers praise you for your work, can perform the task
your are able to finish and perform better ● Explains why some people do the minimum necessary while
others give their all
TWO-FACTOR THEORY (Herzberg’s Two-Factor Principles) ● The more you like the task, the more you can be productive.
● Similar to SWOT analysis ● When the individual is tasked to do the work he likes = will
○ Weakness and Strengths produce good results/output
● Improving the motivator factors increases job satisfaction ● If the individual is tasked to the work he doesn’t
○ Job Satisfaction like/uncomfortable to do = bad output
■ Influenced by Motivator Factors
● Achievement JOB DESIGN
● Recognition ● Job enlargement
● Responsibility ○ Assigning workers additional same level activities,
● The work itself thus increasing the number of activities they perform.
● Advancement ● Job enrichment
● Personal growth ○ Redesigning jobs in a way that increases the
○ Develop skills sets opportunities for the worker to experience feelings of
■ Ex. The individual is motivated by others to responsibility, achievement, growth, and recognition.
perform efficient in the task = produce good ● Job rotation
results ○ Moving a trainee from department to department to
● Improving the hygiene factors decreases job dissatisfaction broaden his or her experience and identify strong and
○ Job Dissatisfaction weak points to prepare the person for an enhanced
■ Influenced by Hygiene Factors role with the company
● Working conditions

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERMS | 2023-2024 | LESSON 3 | LEADERSHIP AND COMMUNICATION

○ Develop skill sets before you can be transferred to a JOB SATISFACTION

different department ● The degree to which individuals feel positively or negatively
about their jobs
BLAKE-MOUTON'S MANAGERIAL GRID ● Common causes of job dissatisfaction (Forbes)
● Country club management (1,9) ○ Micromanagement: no autonomy
○ leader lays more emphasis on the personal needs of ■ management is only the center of the
the subordinates and give less attention to the output decision-making
○ friendly and comfortable working environment ■ No one will own or set up the business
○ Management is focused on people not with the ○ Lack of progress: employees want to feel the work
services they provided matters
○ People-centered managerial approach ■ employee shows no development in
○ Focuses more on the people different aspects of his work
○ Problem: output ■ Lack of development from the employees
■ Business is not working well since the ■ No improvement/upgrade
manager is focusing on the people ■ Employee remained the same despite the
● Task/Produce-or-perish management (9, 1) multiple training
○ leader is more concerned with the production and lay ○ Job insecurity: unstable companies
less emphasis on the personal needs of his ■ company might be bankrupt or having
subordinates unstable revenue
○ the output in the short run may increase drastically, ■ There is a possibility that the business will
but there could be a high labor turnover close or not = unstable
○ Management don't care about the people's feelings or ○ No confidence on leaders
health issues as long as the job needs to be done ■ leaders shows poor supervision and
○ Most common in the PH management
■ The company is not concerned with its ■ Leaders are not competent enough
employees as long as the job is done ○ Lack of recourse for poor performance
■ Ex. Call centers ■ Not allow to reorient the employees for their
● Has quota that must be reached performance to improve
● Despite being tired, you must ○ Poor communication
finish your quota immediately ■ Lapses in communication between the
○ Otherwise, you will be employees
reprimanded ■ No understanding between the employees
○ Job > People ○ Unpleasant coworkers
● Impoverished management (1, 1) ■ Toxic co workers
○ minimal concern for both the people and production ○ Boredom: no fulfillment
(laissez-faire) ● Framework of Job Dissatisfaction
○ function merely to preserve their jobs and seniority ○ Exit: leaving the organization
○ The management really don't care about the people ○ Voice: active and constructive attempt to improve
or the services they provided because they only think conditions (discussions, suggestions, union activity)
that the business must be running. ■ The employee is not being heard during
○ Doesn’t care if the there are people willing to avail its discussions/suggestions
service or produce output ○ Loyalty: passively but optimistically waiting
● Team management (9,9) (speaking up and trusting the management)
○ most effective leadership style wherein the leader ■ You don't trust the management in regards
takes both people and production hand in hand with their promises
○ Management is on-hand with people and it's services ○ Neglect: passively allows conditions to worsen
and they can able to work hand-in-hand to have a (absenteeism, lateness, reduced effort, increased
sustainable and successful business errors)
○ Best ■ The reduced effort from the employees
○ Handles the people and the business; hands-on
○ Can manage the strengths and weaknesses in the COMMUNICATION
business ● Collection and management of information from one or more
● Middle of the road (5,5) sources and the distribution of that information to an audience
○ leader focuses on an adequate performance through ○ Connecting one’s message to another
a balance between the work requirements and ○ Manager—> co-workers
satisfactory morale
○ the organization land up to an average performance COMMUNICATION BARRIERS
○ There are boundaries; neither bad nor good
● Filtering
○ Doesn’t strive for excellence, or produce the worst
○ Planned operation of information to make it more
results
favorable to the receiver
○ Only aiming for average performance
○ Filter the good/bad words to the other person
○ Ex. you only take positive comments, and ignore
negative comments about your performance
● Selective perception
○ Receiving communication is selected by the receiver
depending on their background, experience, needs, or
motivation
○ Ex. you only believe in one person only because that
is somehow close to you or known to you for a long
time
○ One person talks = many listen; another person talks =
no one listens
○ Listen to the person specific for your needs
● Information overload
○ The receiver can't understand the message to the
massive amount of information

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERMS | 2023-2024 | LESSON 3 | LEADERSHIP AND COMMUNICATION

○ You cannot understand the information since you have ● To prevent anticipated problems
a lot of information CONCURRENT ● Control for the present
○ Many discussions/lessons - you can’t understand ● Minimize problems as they occur
anymore
● Emotions FEEDBACK ● Control for the past
○ The emotions of the receiver during the relay of ● To correct problems that have occured
information can affect the transmission (happy, sad,
afraid FINANCIAL MANAGEMENT
○ E.g. if I order you to disseminate information with the
class and you're depressed, then there's possibility DEFINING AND IDENTIFYING COSTS
you can't transmit the information 1. DIRECT COSTS
○ Emotions of the receiver affects the delivery of the ● Expenses that can be easily be traced directly to an
message end product
● Language ● Reagents, consumables, time of the MedTech
○ Words have different meanings to different people 2. INDIRECT COSTS
(cultural background) ● Not directly related to a billable test but are
○ Example: speaking Thai language in Filipino people necessary for its production
● Physical barrier ● Proficiency testing, utility expenses
○ Noise, distance, improper time 3. VARIABLE COSTS
○ information will not be delivered really well ● Change proportionately with the volume of tests
● Personal barrier ○ Price can change based on the demand
○ Attitude of superiors, ignoring the juniors, poor such as tests for sodium-potassium
listening skills, egotism ● Example: reagent costs (the more reagent you use,
the more you spend)
IMPROVING BARRIERS 4. FIXED COSTS
● 2-way channel ● Do not change with the volume of tests performed
○ Two persons must communicate ● Example: rent
● Clarity of the message ● Note: the goal is to produce as much as possible
○ message should be simple, clear, and direct to the from fixed costs to achieve economic scale
point 5. ONE-TIME OPERATING COSTS
○ Simple and clear ● One-time use only, once used, the item has no further
● Speed of transmission value
○ Must be fast ● Reagents, electricity, disposable pipettes, salary
● Positive attitude expense
○ Optimistic mind when you communicate with one 6. CAPITAL ITEMS
another ● Have a useful life greater than one production cycle
○ Positive tone ● Must have a useful life of longer than 1 year
● Open mind ● Example: machines
○ listening more than talking ● Note: with time, capital items lose their value
○ Open with negative/positive feedback (depreciation)
● Effective listening
○ Listen more rather than speak EQUIPMENT COST PER TEST
● Mutual understanding ● costs associated with the test procedure
○ have stronger connection ● ECT = {(E/L) + M} / A
○ Connection with another person ○ E: cost of equipment
■ Know each other’s gestures when it comes ○ L: useful life of the equipment
to different situations ○ M: annual maintenance cost
● Effective feedback ○ A: annual test performed
○ Listen to the feedback so you can improve yourself ● A = {(E/L) + M} / ECT
○ open to any suggestions or comments ● M = (A x ECT) - E/L

CONTROLLING MANAGEMENT AND INFORMATION SYSTEM ● Sample Problem: Machine A costs PHP 750,000 with a useful
life of 5 years. It can perform up to 5,000 tests a year and has a
CONTROL PROCESS maintenance cost of PHP 50,000 annually. How much is the
ESTABLISH Establish Standards equipment cost per test?
● Desired outcome ○ ECT = {(E/L) + M} / A
● Expectations ■ {(750,000/5) + 50,000} / 5,000 = PHP 40
● Relate own standards to your expectation ○ A = {(E/L) + M} / ECT
level ■ {(750,000/5) + 50,000} / 40 = 5000
○ What do you expect if you do this ○ M = (A x ECT) - E/L
■ (5000 x 40) - 750,000/5= 50,000
MEASURE Measure Performance
● Actual Outcome
BREAKEVEN POINT
● Measure performance
○ Laboratory proficiency ● The production level at which total revenues equal total
expenses
COMPARE Compare performance to standard ● Determining the breakeven point
● Higher or lower? ● rx = vx + f + c
● Compare expectations to your actual results ○ r: revenue/test
○ Analyze and take corrective actions ○ v: variable cost
○ If actual performance is low = make ○ x: breakeven point
plans for improvement ○ f: fixed cost
TAKE Take Corrective Action ○ c: net income (0)
● Depends on the comparison ● Example:
○ r: PHP 20/test
TYPES OF CONTROL ○ v: PHP 10
FEEDFORWARD ● Control for the future ○ f: PHP 280
○ 20х= 10x +280 +0

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERMS | 2023-2024 | LESSON 3 | LEADERSHIP AND COMMUNICATION

○ 20x-10x= 280 ○ important to establish means to protect against loss

○ 10x= 280 of data
○ x= 28 ○ For paper-based systems: this will involve using safe
■ 28 tests to reach the breakeven point materials for recording and storing the records
properly.
PAYBACK PERIOD ○ For computerized systems: scheduled or regular
● The length of time required for an investment's net revenue to backup processes become very important.
cover the cost of the initial investment ● protection of patient confidentiality and privacy
● Purchase price of the machine / Annual income of the machine ● effective reporting systems
● Example: ○ Product of the laboratory: test results
○ Price of the machine: PHP 870,000 ○ should provide all information needed by the health
○ Annual income of the machine: PHP 1,400,000/year care provider or the public health official using the
○ 870,000 / 1,400,000/year = 0.62 year or 7.5 months data, and include any comments that are appropriate,
or 224 days (given 1 month = 30 days) such as "sample hemolyzed" or "repeat sample."
● Example: ● effective and timely communication
○ Price of machine: PHP 800,000
○ Annual ROI: PHP 3,600,000 COMMON PROBLEMS
○ 800,000 / 3,600,000 = 0.22 year or 2.6 months or 80 ● incomplete data for test interpretation, or insufficient or illegible
days (given 1 month = 30 days) identification
● forms that are inadequately designed to meet laboratory and
INFORMATION MANAGEMENT client needs
● Application of management techniques in the collection, ● standardized forms prepared by others may not be suitable for
communication, processing, and preservation of data or all laboratories
information ● inability to retrieve data due to poor archiving processes or
● Management of data: both incoming and outgoing patient insufficient backup of computerized information
information ● poor data organization, which may hinder later data analysis
● May be paper-based, computer-based, or a combination of efforts to meet research or other needs
both ● incompatibility between computerized information systems
○ Paper-based = manual and equipment or other electronic systems, resulting in
○ Computer-based = automated problems with data transmission
● data, in particular test results, are the final product of the
laboratory MANUAL PAPER-BASED SYSTEMS
● Need: effective information management system in place in ● Financial constraints may require that a laboratory use a
order to achieve accessibility, accuracy, timeliness, security, manual, paper-based system for all its information
confidentiality, and privacy of patient information management
● LABORATORY INFORMATION SYSTEM ● Samples: manual registers, logbooks, and worksheets
● HOSPITAL INFORMATION SYSTEM ● practical to use and easy to complete
● make it easy to find the data
ELEMENTS TO CONSIDER ● make summarizing data and writing reports easier
● unique identifiers for patients and samples ● Purpose of this is to allow the laboratories to have backup in
○ Patient identifiers: unique identifiers upon admission case the system have another issues like glitches or errors.
to be used upon the duration of the hospital stay
■ A patient may get a new number every DATA ENTRY
admission or a permanent number may be ● In manual entries, it is important to emphasize to staff that all
assigned to the patient to be used in every data entry must be complete.
admission ○ A computerized system usually requires that all
○ Sample identifiers "essential fields" contain data, but in handwritten
■ For tracking in the laboratory; the unique records there is no check on this point.
number will need to be used on all aliquots
of the sample, on the request form, the LEGIBILITY AND HANDWRITTEN REPORTS
laboratory register or log, and the result ● Illegible writing may be a problem, but it must be addressed;
sheet emphasize to employees the importance of legibility
■ Example: 0405130047 ● When handwritten reports are issued, the laboratory needs a
● Sample # 47 received on April 5, copy for its files or archives. Not having an exact copy of the
2013 report can lead to later problems, if errors in transcription occur.
● standardized test request forms (requisitions), logs and
worksheets STORING PAPER-BASED MATERIALS
○ Standardize the test form: should indicate all
○ keep everything, but develop a system for when and
information that needs to be provided when ordering
how to discard (for example, after the appropriate
and submitting a test request, and sufficient space
established retention time, shred records to maintain
for recording the information
patient confidentiality)
○ Ensure the request form is completed
● ensure easy access to information by those who need it
○ Easy for errors to occur
○ Alphabetically and by year
■ Clerical errors
● use a logical system for filing
■ Manual transfer of data from forms to logs,
● use numbers to help keep things in chronological order
keyboard electronic entry, or transcriptions
● use a storage area that will protect against water, fire,
from worksheets to reports
humidity, and vermin as much as possible
■ Suggestion: 2 people must review the data
for accuracy
● there's need to have a COMPUTERIZED LIS: ADVANTAGES
benchmark with your co-worker ● Error reduction
or an assessment by your OC ● Quality control management
officer ● Provisions of options for data searching
● checking processes to assure accuracy of data recording and ○ easier search of patient information
transmission ● Access to patient information
● protection against loss of data (security) ○ accessible anytime
● Generate reports

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERMS | 2023-2024 | LESSON 3 | LEADERSHIP AND COMMUNICATION

● Ability to track reports ○ The intentional release or threat of release of

○ previous and present test results biologic agents (viruses, bacteria, fungi or their
● Ability to track and analyze trends toxins) in order to cause disease or death among
○ performance human population or food crops and livestock to
● Improved capability for maintaining patient confidentiality terrorize a civilian population or manipulate the
● Financial management government (CDC)
● Integration with sites outside the laboratory ○ Laboratories may be the first to identify an unusual
○ able to transmit data from different laboratories organism or cluster of isolates that may signal a
especially send-out tests bioterrorism event
● Manufacturer-provided training
BIOSAFETY LEVELS
COMPUTERIZED LIS: DISADVANTAGES Biological
● Training Safety Description Examples
○ Takes time Levels
● Time to adapt to a new system BSL-4 Microbes are dangerous and excoc, posing a Ebola and
● Cost high risk of aerosol-transmitted infections Marburg
● Physical restrictions which are frequently fatal without treatment viruses
● Need for back-up systems or vaccines. Few labs are at this level,
BSL-3 Microbes are indigenous or exotic and cause Mycobacterium
KEY STEPS ON LABORATORY INFORMATION FLOW serious or potentially lethal diseases through tuberculosis
1. Register patient: patient record (ID#, name, sex, age) must be respiratory transmission.
created in LIS before tests can be ordered; the LIS receives
BSL-2 Microbes are typically indigenous and are Staphylococcus
these data when the px is admitted
associated with diseases of varying severity. aureus
2. Order tests: the physician enters the test in the HIS and sends
They pose moderate risk to workers and the
to the LIS
environment.
3. Collect sample: use barcode
4. Receive sample: scan barcode on the sample containers BSL-1 Microbes are not known to cause disease in Nonpathogenic
5. Run sample: the analyzer will scan and read the barcode healthy hosts and pose minimal risk to strains of
6. Review results workers and the environment. Escherichia coli
7. Release results: transmitted to the HIS
8. Report results: physician views the result on the HIS

BIOSAFETY AND BIOSECURITY

● BIOSAFETY
○ These are measures employed when handling
biohazardous materials to avoid infecting oneself,
others or the environment
○ "PROTECTING PEOPLE FROM BAD BUGS"
○ the containment principles, technologies and
practices that are implemented to prevent
unintentional exposure to pathogens and toxins or
their accidental release WHO, 2006)
● BIORISK
○ risk associated to biological toxins or infectious
agents
● BIORISK MANAGEMENT
○ a system or process to control safety and security
risks associated with the handling or storage and CATEGORY A AGENTS
disposal of biological agents and toxins in CHARACTERISTICS AGENTS
laboratories and facilities (CWA 15793:2011) Easily disseminated and/or transmitted Anthrax (Bacillus anthracis)
○ ISO 35001:2019 from person to person
■ Biorisk management for Laboratories and
other related organizations Can result in high mortality rates with a Botulism (Clostridium
■ The International Standard for any major public health impact botulinum)
organization that tests, stores, transports, Plague (Yersinia pestis)
works with, or disposes of hazardous Smallpox (Variola major)
biological materials Tularemia (Francisella
■ The biorisk management system is based Might cause public panic
tularensis)
on a management system approach, which
Viral hemorrhagic fevers
enables an organization to effectively
(Ebola, Marburg, Lassa,
identify, assess, control, and evaluate the
Machupo)
biosafety and biosecurity risks inherent in
its activities
● The PDCA model is an iterative process used by organizations CATEGORY B AGENTS
to achieve continual improvement of processes and products. CHARACTERISTICS AGENTS
○ Plan: establish objectives, programs, and processes Moderately easy to Brucellosis (Brucella spp.)
necessary to deliver results in accordance with the disseminate
organization's biorisk management policy;
Moderate morbidity and low Epsilon toxin of Clostridium perfringens
○ Do: implement the processes as planned;
mortality
○ Check: monitor and measure activities and
processes about the biorisk management policy and Food safety threats (Salmonella spp.,
objectives, and report the results; Escherichia coli 0157:H7, Shigella)
○ Act: take actions to continually improve the biorisk Glanders (Burkholderia mallei)
management performance to achieve the intended Melioidosis (Burkholderia pseudomallei)
outcomes.
Psittacosis (Chlamydia psittaci)
● BIOTERRORISM
Q fever (Coxiella burnetii)

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BSMLS 3J | LABORATORY MANAGEMENT | MIDTERMS | 2023-2024 | LESSON 3 | LEADERSHIP AND COMMUNICATION

May require enhanced CDC Ricin toxin from Ricinus communis (castor
diagnostic capacity beans)
Staphylococcal enterotoxin B
Typhus fever (Rickettsia prowazekii)
Viral encephalitis (Venezuelan, Western,
and Eastern equine encephalitis)
Water safety threats (Vibrio cholerae,
Cryptosporidium parvum)

COMMON BIOTERRORISM AGENTS

AGENT TEST AND SPECIMENS TREATMENT
ANTHRAX ● Culture: blood, CSF, antibiotics
wounds (rapidly growing (penicillin,
nonhemolytic, quinolones,
nonpigmented dry 'ground tetracycline)
glass' colonies with
irregular edges having
comma-shaped
projections)
● Nasal culture: determines
extent of spore spread in
population
● Immunohistochemical:
tissue
● PCR: can confirm
diagnosis if culture is
negative
● Serology: ELISA, IFA
PLAGUE ● Culture: sputum, blood, antibiotics
lymph. tetracycline;
● Direct FA: respiratory quinolones,
secretions streptomycin,
● Serology: F1-V antigen gentamicin,
assay chloramphenicol);
prophylaxis:
medication for 7
days
BRUCELLA ● Culture: nasal, sputum, Combination
respiratory specimens; antibiotics (6
blood culture is definitive weeks):
● Serology: IFA, ELISA, and doxycycline and
microagglutination (gold rifampin or
standard) to detect quinolone and
antibodies rifampin
TULAREMIA
BOTULISM ● Clinical evaluation needed; Antitoxin can be
laboratory tests are of no administered up to
value; toxin assay may be 24 hours after
useful if toxin present in exposure
serum
● PCR and toxin assay: use
nasal induced respiratory
secretions and blood
SMALLPOX
VIRAL
HEMORRHAGIC
FEVERS

VIRAL HEMORRG+HAGIC FEVERS

VHF AGENT NATURAL MEANS OF TRANSMISSION
Ebola Contact
Marburg Contact
Lassa fever Contact
Argentine (Junin) Contact and aerosol
Bolivian (Machupo) Contact and aerosol
Crimean Congo Ticks and contact
Hantavirus Contact and aerosol
Rift Valley fever Mosquito and aerosol
Dengue Mosquito
Yellow fever Mosquito

AMIGABLE & DEOMAMPO | 7

 FINALS | 1ST SEMESTER | TOPIC #1 – BIOSAFETY IN THE LABORATORY
Lecturer: Prof. Angela Dela Peña

BIOSAFETY
These are measures employed when handling biohazardous
materials to avoid infecting oneself, others or the
environment

“PROTECTING PEOPLE FROM BAD BUGS”

The containment principles, technologies and practices that

are implemented to prevent unintentional exposure to
pathogens and toxins or their accidental release (WHO, 2006)

BIOSECURITY
These are measures employed to protect biohazardous
materials, or critical relevant information, against theft or
diversion by those who tend to pursue intentional misuse

"PROTECTING BAD BUGS FROM BAD PEOPLE"

The protection, control and accountability for valuable

biological materials within laboratories in order to prevent
unauthorized access, loss, theft, misuse, diversion or
intentional release (WHO, 2006)

BIORISK
• risk associated to biological toxins or infectious
agents

BIORISK MANAGEMENT
• a system or process to control safety and security
risks associated with the handling or storage and
disposal of biological agents and toxins in
laboratories and facilities (CWA 15793:2011)

ISO 35001:2019
• The International Standard for any organization that
tests, stores, transports, works with, or disposes of Zoomed in view
hazardous biological materials
• The biorisk management system is based on a BIOTERRORISM
management system approach, which enables an • The intentional release or threat of release of biologic
organization to effectively identify, assess, control, agents (viruses, bacteria, fungi or their toxins) in
and evaluate the biosafety and biosecurity risks order to cause disease or death among human
inherent in its activities population or food crops and livestock to terrorize a
civilian population or manipulate the government
PDCA MODEL (CDC)
• The PDCA model is an iterative process used by • Laboratories may be the first to identify an unusual
organizations to achieve continual improvement of organism or cluster of isolates that may signal a
processes and products. bioterrorism event
• — Plan: establish objectives, programs, and
processes necessary to deliver results in accordance
with the organization's biorisk management policy;
• — Do: implement the processes as planned;
• — Check: monitor and measure activities and
processes about the biorisk management policy and
objectives, and report the results;
• — Act: take actions to continually improve the
biorisk management performance to achieve the
intended outcomes.

MADE BY JOSHUA KINTANAR | MIGUEL ASTRONOMO | DANIEL BUDO 1

 CATEGORY A AGENTS
CHARACTERISTICS AGENTS
Easily disseminated and/or Anthrax (Bacillus anthracis)
transmitted from person to
person
Can result in high mortality Botulism (Clostridium
rates with a major public botulinum)
health impact
Might cause public panic Plague (Yersinia pestis)
Smallpox (Variola major)
Tularemia (Francisella
tularensis)
Viral hemorrhagic fevers
(Ebola, Marburg, Lassa,
Machupo)

CATEGORY B AGENTS
CHARACTERISTICS AGENTS
Moderately easy to Brucellosis (Brucella spp.)
disseminate
Moderate morbidity and Epsilon toxin of Clostridium
low mortality perfringens
May require enhanced Food safety threats
CDC diagnostic capacity (Salmonella spp.,
Escherichia coli 0157:H7,
Shigella)
Glanders (Burkholderia
mallei)
Melioidosis (Burkholderia
pseudomallei)
Psittacosis (Chlamydia
psittaci)
Q fever (Coxiella burnetii)
Ricin toxin from Ricinus
communis (castor beans)
Staphylococcal enterotoxin
B
Typhus fever (Rickettsia
prowazekii)
Viral encephalitis
(Venezuelan, Western, and
Eastern equine
encephalitis)
Water safety threats (Vibrio
cholerae, Cryptosprodium
parvum)
CATEGORY C AGENTS
CHARACTERISTICS AGENTS
Availability Hantavirus
Ease of production and Nipah virus
dissemination
Potential for high morbidity Other emerging pathogens
and mortality that could be engineered
for mass dissemination
Potential major health
impact
COMMON BIOTERRORISM AGENTS
• Anthrax
• Plague
• Brucella
• Tularemia
• Botulism
• Smallpox
• Viral hemorrhagic fevers
MADE BY | JOSHUA KINTANAR, MIGUEL ASTRONOMO, DANIEL BUDO 2
 ANTHRAX o Cell or chick embryo culture: skin lesions
• Tests and specimens (ideal), nasal swabs, respiratory secretions
o Culture: blood, CSF, wounds (rapidly o Electron microscopy, PCR, agar gel
growing nonhemolytic, nonpigmented dry precipitation, serology
'ground glass' colonies with irregular edges • Treatment: vaccinia immune globulin (VIG).
having comma-shaped projections)
o Nasal culture: determines extent of spore
spread in population
o Immunohistochemical: tissue
o PCR: can confirm diagnosis if culture is
negative
o Serology: ELISA, IFA
• Treatment: antibiotics (penicillin, quinolones,
tetracycline)

PLAGUE
• Tests and specimens
o Culture: sputum, blood, lymph
o Direct FA: (Direct Fluorescent antibody)
respiratory secretions Smallpox exanthems.
o Serology: F1-V antigen assay VIRAL HEMORRHAGIC FEVERS
• Treatment: antibiotics (tetracycline; quinolones, VHF AGENT NATURAL MEANS OF
streptomycin, gentamicin, chloramphenicol); TRANSMISSION
prophylaxis: medication for 7 days Ebola Contact
Marburg Contact
BRUCELLOSIS Lassa fever Contact
• Culture: nasal, sputum, respiratory specimens; Argentine (Junin) Contact and aerosol
blood culture is definitive Bolivian (Machupo) Contact and aerosol
• Serology: IFA, ELISA, and microagglutination (gold Crimean Congo Ticks and contact
standard) to detect antibodies Hantavirus Contact and aerosol
• Treatment: Combination antibiotics (6 weeks): Rift Valley fever Mosquito and aerosol
doxycycline and rifampin or quinolone and rifampin Dengue Mosquito
Yellow fever Mosquito
TULAREMIA
• Key symptom: pneumonia with nonproductive • Diagnosis: clinical evaluation; key finding is vascular
cough involvement (petechiae, bleeding, edema, postural
• Tests and specimens hypotension, etc.)
o General laboratory tests not helpful • General tests: leukopenia, thrombocytopenia,
o Culture: bacterium does not grow on elevated AST
ordinary media; needs cysteine blood or • Serology: ELISA, IFA, and PCR
chocolate agar • Treatment: management of hypotension and fluid
o Capsular AG detection or PCR: whole loss
unclotted blood • Note: most VHF has a mortality rate of 15-30% but
o Direct FA and PCR: nasal, induced some like Ebola has a death rate near 90%
respiratory specimens
o Serology: ELISA
• Treatment: gentamicin, streptomycin, ciprofloxacin;
doxycycline as prophylaxis

BOTULISM
• Clinical evaluation needed; laboratory tests are of
no value; toxin assay may be useful if toxin present
in serum
• PCR and toxin assay: use nasal induced respiratory
secretions and blood Supportive treatment
• Antitoxin can be administered up to 24 hours after
exposure

SMALLPOX
• Greatest single killer in human history (500
million people dead)
• HIGHEST LEVEL EMERGENCY: submit specimens
immediately to public health laboratory
• Clinical findings: exanthems
• Tests and specimens
MADE BY | JOSHUA KINTANAR, MIGUEL ASTRONOMO, DANIEL BUDO 3
 FINALS | 1ST SEMESTER | TOPIC #2 – LABORATORY QUALITY MANAGEMENT SYSTEM
Lecturer: Prof. Angela Dela Peña

LABORATORY QUALITY QC QA QMS

• Accuracy, reliability, and timeliness of reported
results
• Challenge: reduce the level of inaccuracy as much
as possible (perform all processes and procedures
in the lab in the best possible way)
• Errors cause problems
QUALITY CONTROL
• Target: accurate results
• Samples with known expected results are tested
before or along with patient samples
o If the expected QC results are obtained, all
the patients' unknown results are likely to
be accurate
• NOTE: QC only targets the analytical part of the
workflow
ASSESSMENTS
• Requirements for the type and frequency of QC
• systematic examination of some part (or sometimes
o Specified in operation manuals, package
all) of the quality management system to
inserts, and regulation standards
demonstrate to all concerned that the laboratory is
meeting regulatory, accreditation and customer
QUALITY ASSURANCE
requirements
• A set of planned actions to provide confidence that
• Types:
processes are working as expected
o Internal audit
• Answers the question: How does the laboratory
o External audit
know it is delivering a high-quality service to its
o External quality assessment
customers?
EXTERNAL AUDIT
• Assesses how well the laboratory workflow (pre,
• conducted by groups or agencies from outside the
ana, post) is functioning
laboratory
• evaluate the quality of performance or compliance
QUALITY MANAGEMENT SYSTEM
with licensing requirements and national regulations
• Encompasses all management activities needed to
• external audits might occur without prior
ensure that the laboratory workflow proceeds
notification
smoothly to provide laboratory services to the
• review the recommendations of the assessors
patients
• identify gaps or nonconformities
• Includes QC, QA, and all necessary management
activities (ordering of supply, directing employees,
INTERNAL AUDIT
financial management, etc.)
• staff working in one area of the laboratory conduct
assessments on another area of the same laboratory
EQUIPMENT
• ISO: The main elements of the quality management
• Calibration and preventive maintenance
system should normally be subject to internal audit
• NOTE: Everyone who uses the equipment should be
once every twelve months.
trained in calibration and daily maintenance.
• Troubleshooting
EXTERNAL QUALITY ASSESSMENT
• Identify the source of the problem and check
• Proficiency testing: external provider (NRL) sends
manufacturer instructions
unknown samples for testing (processed by normal
• No correction: backup instruments, replacement
testing methods and by the usual personnell
instrument during repair, send samples to another
• Rechecking (AFB) or retesting (HIV rapid test):
lab
slides that have been read are rechecked by a
reference laboratory; samples are retested for
interlaboratory comparison
• On-site evaluation: if proficiency testing and
rechecking are difficult to conduct

Made by Miguel Astronomo 1

 RECHECKING AND RETESTING CONTINUAL IMPROVEMENT
• Retesting: common in HIV tests done outside the • Deming’s PDCA Cycle
laboratory and by personnel not trained in
laboratory medicine
• Rechecking: commonly done in AFB smears
o Slides are collected randomly to avoid
sampling bias
o Common method: recheck 10% of the
negative and 100% of the positive
o Blinded fashion: the checker must not
know the original result

STANDARDIZATION
• ISO: International Organization for
Standardization
o Develops standards to ensure quality,
safety, and efficiency of products, services,
and systems
• CLSI: Clinical Laboratory Standards Institute
o promotes the development and use of
voluntary consensus standards and
guidelines within the health care
community
• WHO: World Health Organization
o Disease-specific diagnostic laboratories

CERTIFICATION AND ACCREDITATION

• Certification
o an independent body gives written
assurance that a product, process or
service conforms to specific requirements
o inspection team checks for physical
presence of texts, procedures and
documents
• Accreditation
o authoritative body gives formal recognition
that a body or person is competent to cary
out specific tasks
o observe laboratory staff to ensure that they
perform functions and duties correctly and
competently
• Licensure
o Legal requirement for operation

CUSTOMER SATISFACTION
• Complaint monitoring: tip of the iceberg
• Look into:
o Quality indicators: timeliness, patient
refusals, lost/delayed lab samples/results
o Internal audit: turnaround times
o Management review
o Satisfaction surveys
o Interviews and focus groups

MADE BY MIGUEL ASTRONOMO 2

 FINALS | 1ST SEMESTER | TOPIC #3 – Laboratory Action Plan
Lecturer: Prof. Angela Dela Peña

3. Facilitation visit to assist in the formulation of

STATE OF LABORATORY SERVICES Laboratory Action Plan, implementation and
• Many Clinical Laboratories nationwide do not monitoring
provide Quality Lab services due to inadequate 4. 2nd Assessment of Clinical Laboratory on degree of
resources: (low priority in funding) compliance with standards
5. Report to Management (DOH, NUHL, HFDB)
o Lack of competent manpower OUTLINE OF TOPICS FOR THE ACITIVITY
o Insufficient or antiquated equipment I. Strategies, standards & criteria of LAP
o Lack of reagents, controls and supplies II. Profile of Clin. Lab & list of non-compliances
o Cramped, not well designed physical III. Root cause analysis and formulation of solution
facilities for non-compliances.
o Poorly documented policies and IV. Action plan for implementation of solutions for
procedures LAP.
o Inadequate supervision V. Monitoring of implementation of LAP
o Poor coordination among laboratories VI. Guidelines for initial assessment
DOH INITIATIVES IN IMPROVING LABORATORY VII. Guidelines for facilitation visit
SERVICES VIII. Guidelines of second assessment
IMMEDIATE INITIATIVES LONG TERM INITIATIVES LAP PART I : STRATEGIES, STANDARDS AND CRITERIA
• Designation of National • Strategic Plan NHLN FOR LABORATORY ACTION PLAN
Reference Labs (2000) provides quality, reliable, STRATEGIES OF LABORATORY ACTION PLAN
• Coordinating Committee affordable and accessible 1. Program for Capability Building
for NHLN (2002-04) laboratory information for 2. Leadership and Governance
• Standards for Quality the appropriate 3. Promotion of Rational Use of Lab services
Management System in management of patients 4. Maintenance of Safe Lab services
Clinical Labs (2006-08) and prevention/control of 5. Information Management
diseases. 6. Quality Assurance of Lab services
7. Financing of Lab services
NATIONAL HEALTH LABORATORY NETWORK 8. Support of Research & Ethics in Lab
A Journey To Excellence In Laboratory Services 9. Laboratory Network
STANDARDS AND CRITERIA
IMPLEMENTATION OF THE STRATEGIC PLAN FOR NHLN • For each Strategy, one or more Standards were
REFERENCES FOR STRATEGIC PLAN FOR NHLN: identified which constitute the components of the
1. WHO Asia Pacific Strategy for Strengthening Health Strategy applicable to an individual Laboratory.
Laboratory Services (2010-2015) • For each Standard, one or more Criteria were
2. Macro Plan/Framework & strat plan for NHLN (2011) identified which are necessary item to implement the
STRATEGIC PLAN FOR NHLN (2011-2016) Standard.
• The requirement determines the evidence that a
• Road Map to Excellence
criterion is met.
I. At the NATIONAL LEVEL, DPO No. 2012- 5724
provides the following organizational structure:
- National Unit for Health Laboratories
(NUHL) under the HFDB, DOH.
- National Advisory Council for NHLN
- National Technical Working Group (TWG)
for Implementation of the Strategic Plan for
NHLN
II. At the REGIONAL LEVEL, a Regional Lab
Network Council leads the implementation
through a Regional Laboratory Network.
III. At the LABORATORY LEVEL, each laboratory is
trained to formulate and carry out a "Laboratory
Action Plan" enabling the laboratory to
implement the 9 strategies of the clinical
laboratory.
METHODOLOGY FOR LABORATORY ACTION PLAN
1. Train Lab Staff in Laboratory Action Plan RUBRICS FOR STRATEGY, STANDARDS AND CRITERIA
2. Initial Assessment of Clinical Laboratory on degree
of compliance with standards

Made by Miguel Astronomo 1

 INFORMATION ABOUT THE CLINICAL LAB
1. Date of validity of DOH license
2. Services provided
3. Organizational structure/chart
4. Head of laboratory
5. Date of initial LAP assessment
OBJECTIVES FOR LABORATORY ACTION PLAN
• The objectives state the goals for quality
improvement which the Laboratory Action Plan
desires to achieve and how these goals will be
achieved.
• The goal of the Laboratory Action Plan is to
implement the Strategies of the Strategic Plan for
NHLN by correcting the Non-compliances found
during Initial Assessment for the Laboratory.
• The correction of Non-compliances is done by
ASSESSMENT TOOLS applying the Problem-solving methodology and
• Based on the Standards and Criteria implementing solutions to the Non-compliances.
• For each Criterion, one or more Requirements were 1. The General Objective states the overall purpose
identified that will demonstrate compliance with the or goal of the Laboratory Action Plan.
criterion i.e. To implement the Strategies of the Strategic Plan
for the NHLN.
EXAMPLE
• Requirement (4 digits) 2. The Specific Objectives state the components of
• 4.1.1.1 Policy & procedure for Sanitation, Cleanliness, the problem-solving methodology used in
Orderliness and Labeling (55) formulating the Laboratory Action Plan through
which the goal will be achieved.
METHODOLOGY FOR LABORATORY ACTION PLAN i.e.
1. Training of Lab Staff in Lab Action Plan 1. To determine the root cause of the non-
2. Initial Assessment of Clinical Laboratory - List of compliance/s.
non-compliances are identified 2. To identify and select the best solution to correct
3. Facilitation visits for root cause analysis, formulation non-compliance/s.
of solution, implementation and monitoring of 3. To formulate an action plan that serves as guide in
Laboratory Action Plan. the implementation of solutions for non-compliances.
4. 2nd Assessment of Clinical Laboratory
5. Report to Management NON-COMPLIANCES
LECTURE 2 – PROFILE OF CLINICAL LABORATORY; OBJ • During the Initial Assessment, Assessors from RLN
OF LAP; LIST OF NON-COMPLIANCES assess the degree of Compliance to the Standards
and Criteria of the Strategic Plan by determining if
the Requirements in the Assessment Tools are
complied with by the clinical lab.
• Deviations or deficiencies are called Non-
compliances.
• The Non-compliances will be the basis for the
formulation of the Laboratory Action Plan.
STATING NON-COMPLIANCES
1. Non-compliance are stated specifically what
requirement is absent during the observation.

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 2. The specific non-compliance, not the requirement, is
stated with preceding rubric.

1.3.5.3 – Trainings records or Certificates of Training for

each personnel filed in the Lab.

4.3 The Non-compliance or observed deviation shall be stated

in specific terms to facilitate Root Cause Analysis. If the Non-
compliance is vague or not specific, the Root cause(s) may not
be determined resulting in inappropriate solutions.

4.4 Listing of Non-compliances is arranged by Strategy and

Criterion preceded by the Rubric no. of the Criterion and
Rubric no. of the Requirement(s)

ROOT CAUSE ANALSIS AND FORMULATION OF

SOLUTION FOR EACH NON-COMPLIANCE
Root Cause Analysis
• Determines the basic reason or factor for the non-
compliance.
Formulation of Solution/s
• Identify solution/s that would eliminate the non-
compliance.
Why do root cause analysis?
• In order to solve a problem or institute quality
improvement, one should determine the cause. To
successfully solve the problem, one should find the
true cause or the "Root Cause"
• The root cause is the basic factor for the occurrence
of the non-compliance and should be addressed in
order to eliminate the non-compliance.
ROOT CAUSE ANALYSIS
• Depending on the type and severity of the non-
compliance, the root cause may be determined by:
o simple analysis or investigation
o Quality Improvement Study (QIS)
o Continuous Quality Improvement (CQI)
• Find the root cause by asking "WHY" five times. The
initial answers may be "symptoms" rather than root
cause. Ask why on the initial replies 3 or more times
to get to the Root cause.
• The Root Cause is the cause which should be
addressed by the solution or its activities to comply
with the requirement/Criterion.
• In most cases, the reason for the non-compliance is
simple such as "lack of policy or procedure". Such a
problem does not need a complex study to
determine the root cause.
• Example: NON-COMPLIANCE: No record of
inventory of reagents. ROOT CAUSE: No policy to
record the inventory of reagents.
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 • The root cause for a Non-compliance may vary in TABLE FOR NON-COMPLIANCES ROOT CAUSES &
different labs. Sometimes, it is due to lack of policy. SOLUTIONS
In others, there is a policy but no record is made.
TABLE FOR NON-COMPLIANCES ROOT CAUSES &
SOLUTIONS

IDENTIFICATION OF SOLUTIONS
• Solutions are interventions that address the root
cause and eliminate the non-compliance
• For each root cause, identify the solution that would
eliminate the non-compliance.
• The Solution is an overall statement that will ACTION PLAN
eliminate the Non-compliance. Detailed actions • An Action Plan is a tabular presentation of solution
undertaken to implement the solution are Activities for non-compliances.
for the Action Plan. • Solutions are grouped into categories so that each
STATEMENT OF SOLUTIONS table bears the Category of solution on top left.
To facilitate determination of activities of each solution (in the • For each solution, the activity, person responsible,
Action Plan), the solutions are stated in a uniform manner time and resources are determined including the
(Category) using an active verb. indicator that will show that the solution has been
implemented.
Examples of Categories: • Make sure that the activity indicated shall address
1. Formulate a Policy and Procedure the root cause and eliminate the non-compliance
2. Secure Certificate or Record of Training of Staff
3. Conduct a study
CATEGORIES OF SOLUTIONS
1. Formulate a Policy or Procedure on ....
2. Modify an existing Policy or Procedure on .
3. Develop brochures, flyers, posters and information
material on ....
4. Issue communication to management, medical staff
or external agencies on ....
5. Obtain a Certificate or Record of Training of staff in ....
6. Implement and monitor Policy or Procedure on ....
7. Conduct a study on ....
8. Record and/or report results, observations, activities,
incidents in ...
9. Hire, Assign or change the assignment of Personnel
in ....
10. Procure (equipment, medicines, reagents and other Table of Action Plan
supplies) All columns should be filled-out:
11. Calibrate/repair of .... (equipment) • What: Activities (actions/steps) are needed to
12. Sort/label .... (supplies and material) implement the solution.
13. Secure a copy of Procedure, Manual on ..... • Who: will be responsible to ensure that the specific
14. Install/construct (fixture, cabinet, etc.) activity is carried out.
STATEMENT OF SOLUTIONS • When: the due date of the activity.
To be precise about what the solution will correct, the specific • Resources needed: Manpower (not the key
object of activity should be stated. responsible person), equipment, materials, funds, etc.
needed to carry out the activities.
Examples: • Indicator: Observable parameter that will show
1. Formulate a Policy and Procedure on procurement of evidence of the completion of the activity.
Equipment.
2. Secure Certificate or Record of Training of Staff in
Liquid Waste management.
3. Conduct a study on improving TAT.
4. Install an emergency shower.
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 Gantt Chart
Based on the Action Plan
1st Column – Solutions under the Strategy preceded by
Requirement no(s).
2nd column – Person who is in-charge for the activity
3rd column – Timeline: The date of start and date of
completion. Shade the periods during which the activity
will be done.
4th column – State remarks, if any.
Signed out by the person who prepared, reviewed and
approved

GANTT CHART FOR SOLUTIONS

• To graphically show the time frame for the
implementation of the solutions, a Gantt Chart is
drawn for each Strategy.
• Timelines are shaded to indicate when the solutions
are planned to be carried out.
• The Gantt Chart represents the month and week (or
week and day) during which each activity will be
implemented.
• This will later be the basis for monitoring whether the
solutions are completed as planned.

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