Patty Enrado wrote in Healthcare Finance News
493), with specific
in 2009, “Labor costs continue to be hospitals’
biggest expense” (4). This statement includes
the clinical laboratory, where human resources
account for 42% of the laboratory budget
(Truven Health Analytics,
http://truvenhealth.com/products/ action_oi.aspx
[accessed June 27, 2013]. maximizing
utilization of staff is a key to controlling
expenses in the laboratory. The education and
experience required of the staff as well as staff
scheduling models can optimize laboratory
operations.
Increasing Opportunities for Medical
Technologists
The Bureau of Labor Statistics, in the
Occupational Outlook Handbook, lists related
fields in chemistry, materials science, veterinary
technologists, technicians, and assistants. Also
available to laboratory personnel are positions in
manufacturing and industry, including sales,
technical support, and research and
development positions.
Personnel Requirements
Education
Medical and clinical laboratory technologists
generally have a bachelor’s degree in medical
technology or one of the life sciences or a
combination of formal training and work
experience. Technicians generally have either
an associate’s degree or certification from a
hospital vocational or technical school.
Several programs provide certifications for
technologists and technicians or training
program guidelines, including the American
Society for Clinical Pathology (ASCP), the
American Society of Clinical Laboratory
Scientists (ASCLS), the National Credentialing
Agency, and the Clinical and Laboratory
Standards Institute (CLSI), formerly the National
Committee for Clinical Laboratory Standards
(NCCLS).
The basic requirements for personnel to perform
testing in a clinical laboratory are proscribed in
the Clinical Laboratory
Improvement Amendments of 1988 (CLIA ’88).
Tests are grouped by complexity (as defined
within the CFR Sec.
licensure, education, or experience
requirements for each complexity model. The
degree required for testing personnel varies and
includes doctors of medicine or osteopathy;
doctoral, master’s, or bachelor’s degrees;
associate degrees; or high school diplomas.
The common denominator is documented
training for each individual performing
laboratory testing, based on the complexity of
the tests performed.
The credentialing options (for example, bachelor
of science degree in medical technology or
chemistry, or high school diploma plus military
training) provide the laboratory manager with
flexibility in hiring decisions and scheduling.
Training and Competence Assessment
Accreditation processes address the need for
continuous training for laboratory staff. In the
2012 General Checklist, the CAP states that
there should be “a functional continuing
clinical laboratory education program
adequate to meet the needs of all personnel”
and that “the competency of each person to
perform his/her assigned duties is assessed”
Each technologist or technician must be
competent to perform laboratory tests based
on the specific policies and procedures of the
laboratory. Training and competence must be
documented within personnel records. In
addition, on-the-job training may be integrated
into the laboratory for those with the minimum
education required. Consideration should be
given to on-the-job training, especially for
laboratory assistants or phlebotomy staff, for job
improvement and promotion.
Generalist versus Specialist
The staffing model widely used 30 years ago
was based on specialists for every discipline in
the laboratory. Labor saving
instruments and computerization have changed
the testing process in the laboratory, allowing
ease of test performance.
Generalists can be cross-trained for all
laboratory sections. Cross-training can be
defined for staffing purposes as training an
individual to perform testing in more than one
functional area of the laboratory.

Traditionally, medical technologists were
assigned to a specific section, e.g., hematology
or chemistry, and their competency was
assessed only for those tests performed in that
area. By training personnel to perform testing in
multiple areas of the laboratory, the laboratory
manager has the skill mix available to assign
individuals where the need is greatest at the
time.
Cross-training generalists, however, may not be
advantageous for very complex facilities for all
areas of testing.
Esoteric or highly specialized disciplines
need the depth of knowledge that a specialist
provides.
Generalist versus Specialist Staffing Models
Test mix
A large test menu, including moderately and
highly complex tests, requires a different group
of technical staff than a laboratory performing
mostly routine testing on automated analyzers.
Specialty areas in microbiology, surgical
pathology or cytology, and blood bank also
require special consideration.
Hours of operation
A full-service laboratory supporting an ER
and/or intensive care units requires a different
pattern than an outpatient laboratory or POL
providing services Monday to Friday for one
shift. Staff must be available to support the
emergency room and critical care units, at least
for those tests that must be available as STAT
tests at all times. The STAT test menu is an
important tool for the laboratory manager to
ensure adequate staffing at all times to meet the
expectations for services provided.

Model Pros Cons Supervision

The requirements for on-site technical
supervision in CLIA ’88 mandate the need for
Generalist
- Staffing - Increased technologists in addition to technicians on off
flexibility resource shifts, weekends, and holidays
- Entry allocation to
level maintain
opportuni and Service levels
ties document Turnaround time, phlebotomy, results reporting,
staff and sequential testing are all variables to
- Breadth
competency
of consider when staffing the laboratory. An
knowledg - Entry level,
as staff gain outpatient laboratory may provide all test
e
experience results by the next day, allowing for a smaller
in tenure staff to perform specimen collection during the
- Lack of day, with batch testing performed in the early
depth evening. A full-service laboratory performing
tests for the ER will require testing personnel 24
Specialist
- Depth of - Narrow hours/day to perform a STAT test menu with
knowledg base of turnaround times within minutes.
e experience
- Career - Limited Services supported
ladder flexibility in
scheduling
Laboratories that support level 1 trauma centers,
- Opportun
ity
transplant programs, cardiovascular surgical
Laboratory Staffing programs, and clinics, to name a few, could
have different minimum staffing requirements
Staffing Requirements than a general acute-care suburban facility.

The laboratory manager must assess the Productivity levels

needs of the laboratory to determine the
number of employees needed as well as the mix
of expertise, training, or credentials of technical
staff. The following are elements within the
laboratory that should be addressed.
The author has based productivity goals on a
“traditional” 80% productivity measure. The key,
however, is to know how to define the term
“productivity,” including the metrics to measure
productivity. For example, if the amount of time
available to work is used as maximum
opportunity, then the 8-hour day is actually 7
hours (assuming 1 hour for lunch and breaks).
100% productivity of available work time is 87%
of total worked time. Productivity is also a
useful indicator to determine optimum staffing
in conjunction with minimum staffing.
Productivity levels are also based on the unit
of measure used, typically the number of billable
tests. However, the mix of billable tests
(inpatient versus outpatient, STAT versus
routine, increased nonbillable components) can
impact productivity comparisons. Assessing
staffing needs daily, or even on a shift-by-shift
basis, ensures tighter control of labor expense,
as long as trained staff are available to “flex-up”
or staff is willing to “flex down” as volume
changes. Both are key components of the flex
(variable) staffing model.
Basis for Determination: Workload
Recording
Some method should be used to objectively
document the amount of “work” performed by
the laboratory. The units of
work are factored by the hours required to
perform the work to determine productivity. The
Laboratory Management Index
Program (LMIP) is one program that provides
benchmarks for productivity, utilization, and cost
effectiveness. The standard billable test (SBT) is
the primary unit of measure for LMIP. The SBT
is a method of standardizing test counts and
eliminates billing, accounting, and interpretation
variations to ensure that valid comparisons are
created.
There are other productivity measurement tools
as well, such as the Thomson-Reuters Action
O-IR operational improvement tool
(http://truvenhealth.com/products/action
_oi.aspx) that measures labor productivity
(primarily) for
acute-care hospitals, including all departments
within the hospital. Laboratories are reported in
this database based
on hours worked or paid per billable test,
adjusted days, or adjusted discharges.
The key to workload recording is to determine
the basis for calculation, while reducing the
variables that can affect the comparisons and
limiting the exceptions that will skew
performance. The key to productivity
comparison is understanding the variables
among laboratories, including outpatient
volumes, services supported, overall size and
scope of the laboratory, and availability of
alternative testing sites.
Staff Scheduling
Once the staffing mix has been developed and
implemented, employees must be assigned to
their work schedules. To schedule staff
effectively, the laboratory manager must
understand the needs of the laboratory,
hours of operation, and the staff required
versus the needs of the employees, for whom
a work-life balance is becoming more important.
When the laboratory manager can include
employees in the scheduling process, individual
needs can be considered, as long as business
needs are met. Some facilities have
implemented self-scheduling. Following
scheduling guidelines for skill level and number
of shifts, among other factors, employees select
their own schedules, based on their preferences.
Self-scheduling is available on a first-come, first-
serve basis.
If self-scheduling is not available, at minimum
the laboratory manager should utilize employee-
driven methods
for scheduling shifts, including the opportunity
for same-skill employees to trade shifts with
approval.
Some laboratories utilize a flexible or variable
staffing model to flex up or down based on
volume.
Key Success Factors
two key success factors are financial
performance and quality assurance.
When reviewing staffing and scheduling, labor
costs can be used to target areas of opportunity
for improvement. The cost
of overtime and turnover will affect overall
person-hour and expense budgets. The
achievement of targeted performance metrics
influences the satisfaction of customers (e.g.,
physicians, patients).
Metrics for Success
Reporting efficiency
Laboratories have measured their reporting
efficiency in terms of percent of tests
reported within required or requested time
frames. This metric is particularly important to
those who take action on the test results, as
treatment options and procedures depend on
laboratory results. Reporting efficiency also
can affect the financial performance of the
hospital. When laboratory results are available
and patient care is delivered efficiently, the
patient length of stay may be decreased.
Turnaround time
Turnaround time for results reporting includes all
components of testing—specimen collection,
processing, analysis and review, and reporting—
and is an important indicator of effectiveness as
well as efficiency.
One component, specimen collection, can and
should be monitored separately, whether the
laboratory has responsibility
for collecting patient samples or nursing units
provide for specimen collection. The metric is
the percent of tests collected within a time frame
around the test request.
For example, a hospital laboratory may report
the percentage of 6 a.m. labs collected between
5:30 a.m. and 6:30 a.m.
When the laboratory objective is to complete all
timed blood draws within 30 minutes of the
requested time, the laboratory manager has to
staff sufficient numbers of employees to meet
this objective.
Productivity measurements
The productivity of the laboratory is a function of
the number of tests performed by the
number of personnel working, or workload
units per full-time equivalent.
Impact on staff
The implementation of productivity
measurements can affect the laboratory staff.
Productivity measures are an objective,
quantitative means of reviewing performance
but may be perceived as changing the
workplace from a laboratory to an assembly line,
where productivity is the only indicator of
laboratory success. By including quality
indicators such as proficiency surveys of
performance in laboratory metrics, the
laboratory manager can emphasize the
importance of quality as well as productivity.
Scheduling processes
At a minimum, the manual schedule is prepared
for the staff in advance. Scheduling software
programs are available that include parameters
for skills and training. The need for computerized
scheduling is dictated in part by the size of the
laboratory staff and the time available to devote
to maintaining a manual versus a computerized
system. Laboratory managers should examine
the time required to prepare, distribute, post, and
amend manual schedules and compare the
labor intensity with the cost and implementation
of a computerized process.
Alternatives
Outsourcing
Reference laboratories have in the past provided
esoteric testing not usually done in clinical
laboratories. With overnight testing and air
couriers, reference laboratories have expanded
their menus to include routine testing. Routine
testing that can be performed by a reference
laboratory that provides 24-hour turnaround time
could include any test that is not part of the
STAT grouping (tests that must be reported
within specific time
frames to maintain patient safety).
Opportunity cost and benefit
The laboratory manager should consider the
impact of staffing decisions on the facility or
physician using the laboratory. The manager
should also consider the opportunity to combine
job functions across departmental lines when
feasible to take full advantage of the benefits
provided.
For example, locating the phlebotomy staff on
nursing units provides efficiency for the
laboratory in less travel time to the patient and
also provides nursing units with ancillary
personnel trained to provide defined levels of
patient care. In some facilities, nursing services
has the responsibility for specimen collection,
utilizing their RN staff or training patient care
assistants for phlebotomy.
Creative scheduling
Creative scheduling includes opportunities for
job sharing, flextime, part-time,
telecommuting, and self-directed teams
Similarly skilled and trained employees can elect
to share a position. This often decreases fringe
benefit costs while providing equal hours hands-on time
worked. The staffing pattern of a hospital is determined
based on the assigned classification, bed
Flexible scheduling capacity and organizational structure of the
based on employee need or request, can result hospital. (Ref. DOH Circular No 2013-0349
in increased employee satisfaction, reducing Revised Standards on Organizational Structure
turnover and poor performance. and Staffing Pattern of Government Hospitals
CY 2013 Edition
Telecommuting
for specific positions such as medical
transcription reduces space requirements for the
laboratory, may enhance
work performance, and provides an additional
resource of experienced employees.

Using self-directed teams reduces the time

demands on the laboratory manager while
providing job enrichment and satisfaction.

Flexible Staffing
More hospitals today are using a variable
staffing method for hospital departments that
can “flex to volume,” including the laboratory.
The premise is that FTEs are budgeted based
on the volume projected and the variable
workload target that has been established (via
external benchmarks, history, minimum staffing
or service line support, or some combination of
these). When actual volume exceeds budgeted
volume, budgeted hours increase to match.
Conversely, when actual volumes are less than
budget, hours are decreased.

Scheduling Alternatives
Alternative Pros Cons
Job sharing Decreases Potential lack
benefit costs of continuity
Flexible Employee Must be
schedules satisfaction administered
consistently
and in
accordance
with human
resource policy
Part-time Increases pool Lack of
schedules of employees continuity
Telecommuting Reduces Limited to
overhead specific jobs,
requirements, cost to
employee establish and
satisfaction maintain links
to the
laboratory
Self-directed Employee Consistent
teams satisfaction, application of
reduces policy
management

COMMON SCHEDULE PATTERNS
MEDICAL TECHNOLOGY INTERNS
AM SHIFT : 7:00 AM to 3:00 PM
PM SHIFT : 3:00 PM to 11:00 PM
NIGHT SHIFT : 11:00 PM to 7:00 AM
REGISTERED MEDICAL TECHNOLOGISTS
AM SHIFT : 6:00 AM to 2:00 PM
PM SHIFT : 2:00 PM to 10:00 PM
NIGHT SHIFT : 10:00 PM to 6:00 AM
CHIEF MEDTECH AND SUPERVISORS
8:00 AM to 5:00 PM
Sample work schedule
Policy and Procedure Manuals (Ref. WHO.
Laboratory quality management system:
handbook. 2011 CHAPTER 16)
Significance of Document Management
- A major goal in keeping documents and
records is to find information
whenever it is needed.
Documents
- are all the written policies, processes
and procedures of the laboratory.
- they are essential for assuring accuracy
and consistency in the laboratory.
Characteristics of Documents are that they:
- communicate information to all persons
who need it, including laboratory staff,
users and laboratory management
personnel;
- need to be updated or maintained;
- must be changed when a policy,
process or procedure changes;
- establish formats for recording and
reporting information by the use of
standardized forms—once the forms are
used to record information, they become
records.
What is a Policy?
- It is a documented statement of over all
intensions and direction defined by
those in the organization and endorsed
by management.
- They give broad and general direction to
the quality system
- They tell “ What to do” in a broad and
general way
- They include a statement of
organizational mission, goals, and
purpose
- They serve as the framework for the
quality system, and should always be
specified in the quality manual
What is a Process?
- Are the steps involved in carrying quality
policies
- A set of interrelated or interacting
activities that transform inputs into
outputs
- Another way of thinking about a process
is as “how it happens”
- It can be represented in a flow chart,
with a series of steps to indicate how
events should occur over a period of
time
What are Procedures? Hazards of the workplace: A matter of attitude
- Are specific activities of a process
- A procedure tells us “how to do it” and - we must be constantly aware of the
shows the step-by-step instructions that safety elements that surround us
laboratory staff should - take the steps that are conducive to
meticulously follow for each activity a safe working environment
- The term Standard Operating - ensure that the measures necessary
Procedure (SOP) is used to indicate to protect ourselves from any threats
these detailed instructions on how to do to our well-being are in place
it

Job Aids The role of the employee:

- Job aids, or work instructions, are - The individual must ultimately

shortened versions of SOPs that can be assume responsibility for his or her
posted at the bench for easy reference health and safety.
on performing a procedure.
- They are meant to supplement, not The role of the employer:
replace, the SOPs.
- obligated both morally and legally to
see that employees have the
Document Hierarchy
training, support, equipment,
workload, resources, environment
A good way to represent the relationship of
and oversight necessary to perform
policies, processes and procedures is as a
in a safe and secure manner.
tree.
Laboratory safety must be taught to:
The Policies are represented by the roots, and
they form the base for all the other parts.
- all employees, including service
groups
The Processes can be viewed as the trunk of
- undergraduate students
the tree, representing a series of steps or flow of
- graduate students
actions through the laboratory.
- professors
- visitors
The leaves of the tree can be thought of the
Procedures; there will be many procedures in
General Rules:
the laboratory for accomplishing the activities or
the work.
- Do not eat or drink in the laboratory
Laboratory Safety
- NO mouth pipetting
- is a concern for all personnel - NOT allowed to work in the
- vital part of any total quality control laboratory alone
program - Wear required personal protective
- involves injuries that affect the equipment
morale and threatens the emotional - NO smoking in laboratory
and physical health of the individual - Maintain good housekeeping habits

Why is Laboratory Safety Important? HAZARDS IN THE WORKPLACE

TO PREVENT:
- Fire hazards
- adverse health effects from - Faulty electrical equipment
exposure to chemicals - Poor ventilation
- exposure to organisms, diseases, - Blocked entrances and exits
etc. in laboratories - Hazardous clutter
- laboratory equipment hazards - if - Poor lifting and handling techniques
not maintained properly - Unmet building safety requirements
FIRE PREVENTION The “fire diamond” by National Fire
Protection Association (NFPA) quickly and
Three ingredients of fire: easily identifies the risks posed by nearby
1. Ignition source hazardous materials.

2. Oxygen
3. Fuel
“Control the union of fuel and ignition
sources.”

Fire prevention strategies:

- Keep flammable substances in
separate rooms & storage cabinets.
- Use fire-resistant building products,
explosion-proof refrigerators and
hoods.
- Perform procedures that result in
highly combustible reactions under
water and vacuum chamber.
- Fire-fighting equipment (automatic
sprinklers, self-closing doors, fire
hydrants, fire extinguishers, fire
blankets) must be available at all
times.

TRAINING AND PRACTICE

CLA FIRE TYPE ACCEPTA EXTINGUI

SS BLE SHER
EXTINGUI RATING
SHER REQUIRE
MATERIA D
L
A Common Water A, B, C
combustible
material
(paper, wood,
etc.)
B Flammable Dry B, C
liquids: chemicals,
alcohol, CO2
solvents,
plastics
(furniture)
C Electrical: Dry C
wiring, chemicals,
equipment CO2/foam
D Chemicals/ma Sand D OR
terials: SAND
magnesium, BUCKET
sodium,
titanium
ELECTRICAL SAFETY

Two Major Hazardsn of Electricity:

- Physical harm from shocks or burns

- Dangers from fire caused by heat
and sparks generated

Safeguards recommended by NFPA:

- There should be no extension cords

or adapters.
- All equipment should be checked in
compliance with electrical safety
standards.
- Electrical safety checks should be
part of laboratory preventive
maintenance.
- Circuit breakers should be
conveniently located and labeled.
- Electrical equipment should not be
used in areas with flammable
materials.
- Electrical safety should be part of
the orientation and educational
program of the laboratory.

CHEMICAL SAFETY

The Occupational Safety and Health

Administration (OSHA) classifies chemical
hazards into two groups:

Physical Hazards
- compressed gas
- Explosives
- Flammable: aerosol, gas, liquid or
solid
- Organic peroxide
- Oxidizer
- Pyrophoric ( i.e., capable of
spontaneous ignition when exposed
to air)
- Reactive/unstable
- Water-reactive

Health Hazards
- Toxic & highly toxic agents
- Reproductive toxin
- Carcinogen
- Irritant
- Tissue corrosive
- Sensitizer
- Liver, kidney & CNS toxins
 - Agents that act on or damage other
body systems To provide barrier to splashes,
splatters, aerosols or sprays
Material Safety Data Sheets (MSDS)

- Summary of the hazardous nature of

chemicals used in the workplace
- Must be maintained and updated
- Must be provided for all products by
the manufacturers

It specifically includes:

- chemical identity
- chemical name and common name
- physical and chemical characteristics
- signs and symptoms of exposure
- routes of entry
- exposure limits
- carcinogen potential
Body clothing (e.g. labgowns,
- safe handling procedures
surgical caps, scrub, shoecover)
- spill cleanup procedures
- first-aid tips (must be available in all
cases of emergency) To protect parts of the body not
covered by gloves or eye and face guards from
the threat of
Personal Protective Equipment (PPE) contamination

- Masks
- Goggles
- Safety glasses
- Visor
- Gloves
- Rubberized sleeves
- Proper footwear

Gloves

To protect the hand from the

possibility of coming in contact
with blood/OPIM

It has been estimated that almost 20% of all

disabling accidents on the job involve the
hands.
Without your fingers or hands, your ability
to work would be greatly reduced.

Eye and face protection items

(e.g. face masks, goggles,
glasses, hoods)
 - Flushing down the drain to the
sewer system
- Incineration
- Landfill burial
- Recycling

Incineration
OSHA PATHOGEN REGULATIONS
- preferred method for the waste
treatment of hazardous chemical
1. UNIVERSAL PRECAUTIONS
waste
- flammable materials can also be
- a policy of treating ALL blood, tissue, body
burned in especially designed
fluids and OPIM (other potentially infectious
incinerators with afterburn and
materials) as INFECTIOUS
scrubbers to remove toxic products
of combustion
2. ENGINEERING AND WORK PRACTICE
CONTROL

- involve taking physical steps to isolate or

remove any possible pathogen hazards from the
Landfill Burial
workplace

Examples: - the landfill site must be licensed to

a. Sharps’ containers
b. Biological safety cabinet
c. Laboratory fume hoods
d. Proper hand washing and hand washing
facility
e. Banning of eating, smoking and drinking
inside the laboratory
accept hazardous waste
- used for solid chemical waste that are
unsuitable for incineration
- has caused environmental problem,
shortage of safe site
Recycling

3. PERSONAL PROTECTIVE EQUIPMENT - for solvents such as xylene and

acetone that can be filtered or redistilled for
- Gloves must be worn when coming in contact reuse
with specimens and other hazardous chemicals - for papers either scratch or scrap and
and OPIM. sold to scrap buyers
- Gloves must be replaced every after one
patient and when the protective integrity is
compromised.
- Eye and face protection items Common warning symbols
- Protective body clothing (lab.gowns, aprons,
lab.coats, surgical caps and scrubs, shoe
covers, and disposable arm sleeves)

4. HOUSEKEEPING TECHNIQUES

- must ensure that the workplace is maintained

in a clean and sanitary condition.

Example: “Double-bagging” properly

labeled with a warning and instructions for
dealing with a leak or spill.

METHODS OF WASTE TREATMENT

 - refers to control of the activities employed in
the handling of samples and examination
processes in order to ensure accurate and
reliable testing

QC - monitors activities related to the

examination (analytic) phase of testing

The goal of QC - is to detect, evaluate, and

correct errors due to test system failure,
environmental conditions or operator
performance, before patient results are reported
Laboratory quality

- can be defined as accuracy, reliability

Quality control (QC)
and timeliness of reported test results
- laboratory results must be as accurate
- is a component of process control, and
as possible, all aspects of the laboratory
is an essential element of the quality
operations must be reliable, and
management system
reporting must be timely in order to be
- it monitors the processes related to
useful in a clinical or public health
the examination phase of testing and
setting
allows for detecting errors in the testing
system
in order to achieve the highest level of
- gives the laboratory confidence that test
accuracy and reliability, it is essential to
results are accurate and reliable before
perform all processes and procedures in the
patient results are reported
laboratory in the best possible way.

Steps for implementing and maintaining a QC

Factors that must be addressed to assure
Programme include:
quality in the laboratory
- establishing written policies and
- the laboratory environment
procedures, including corrective actions
- quality control procedures
- training all laboratory staff
- communications
- ensuring complete documentation
- record keeping
- reviewing quality control data
- competent and knowledgeable staff
- good-quality reagents and equipment
Types of Quality Control

Internal QC

- is compost of the operational techniques

If inaccurate results are provided, the
used by the laboratory staff for
consequences can be very significant,
continuous assessment of the quality of
including:
the results of individual analytical
procedures
- unnecessary treatment
- a set of procedures for continuously
- treatment complications
assessing laboratory work and the
- failure to provide the proper treatment
emergent results
- delay in correct diagnosis
- additional and unnecessary diagnostic testing
External QC (inter-laboratory control)

- control samples that do not come with

Process control
the test kit
- they are provided by an external source
such as the regional reference
laboratory or a commercial supplier
- this type of control should also be tested
in the same manner as you would test a
patient or client specimen
- carried out periodically and checked by
the laboratory responsible for the
monitoring system
histogram

Quality control samples
- quality control samples should be
treated in the exact same manner as the
test samples and are used to validate
the test run
- each laboratory should develop a criteria
for run acceptance based on guidance
from the manufacturer's kit insert and in-
lab validation of an external QC sample
Kit Controls - the negative and positive control
provided with the kit
Quality Control Sample - a low positive
externally produced sample
Reagent QC
- each day of use, the technologist must
confirm that the reagents react as
expected when used as described in
the laboratory's procedure manual
- if a reagent does not give the
expected result, it must be repeated.
if the results are still incorrect, a new lot
number must be tested
- the QC done is only to test for
specificity. titer and avidity are checked
by the manufacturer before the lot
number is released for use
- results of daily QC must be recorded in
a notebook or ledger, along with
manufacturer, lot number, and outdate
the person doing the testing must be
identified, and the date of testing must
be recorded
Equipment Control Measures
A system of equipment control should
include:
- a suitably maintained equipment register
and supporting records
- procedures for the provision of adequate
quantities of suitable equipment to meet
the established requirement
- a means of repairing equipment with the
least possible delay
- clear operating instructions where
applicable
- procedures to monitor the viability of
equipment repair
- additional monitoring of those assets
that are particularly portable and
attractive eg. laptop computer, camera;
- responsibility for the care and control of
equipment delegated to an appropriate
level
- proper housing and or protection and
clear identification
- the conduct of a stocktake at least once
each year
- replacement action when required
- identification of excess equipment for
disposal
- removal of all information and data from
equipment upon disposal or transfer to
an external agency
- computer equipment, in particular, must
have hard drives cleaned to delete all
software and data
- prohibition of, and identification of, illegal
and/or unauthorised modifications to
equipment that must not be performed
Controls are implemented to avoid following
equipment management problems:
- non-registration of equipment
- stockpiling of equipment (retaining replaced
equipment unnecessarily)
- unauthorised ordering of equipment
- excessive usage of equipment
- unauthorised use of equipment
- loss of equipment
- abuse of equipment
- unreported incidents
- suspicious stocktake adjustments
- illegal disposal of equipment
- lack of physical security
- poor attitude to equipment management
- equipment register data accuracy and quality
Six Sigma  
Six Sigma stands for 6 standard deviations (6σ)
between average and acceptable limits
- is a disciplined, statistical-based, data-
driven approach and continuous
improvement methodology for
 eliminating defects in a product, process
or service
- can also be thought of as a measure of
process performance
- is a set of techniques and tools for
process improvement
Six Sigma quality control
- uses a variety of tools and statistics to
not only find the problem quickly, but
also to fix it and continue to monitor it
- controlling problems produces higher
customer satisfaction and can reduce
unnecessary costs for a company
- they create the highest level of product
quality while still meeting goals and
objectives
- is used as it describes a target of 3.4
defects per million opportunities which is
considered to be world class  and prevention
- Sigma is the term given to a measure of
deviation in a data set
The tools are applied within a simple
performance improvement model known as
Define-Measure-Analyze-Improve-Control, or  -
DMAIC
D – define the goals of the improvement activity
M – measure the existing system
A – analyze the system to identify ways to
eliminate the gap between the current
performance of the system or process
and the desired goal
I – improve the system
C – control the new system
Proficiency Testing
- is a means of assessing the ability of
laboratories to competently perform
specific tests and measurements
- an important means of quality
- one of the best ways for an analytical
laboratory to monitor its performance
against its own requirements and the
norm of other laboratories, is to
participate in it regularly
- it helps highlight repeatability and
reproducibility performance of the
laboratory
Calibration
- is a comparison between measurement
devices one of known magnitude or
correctness (standard reference
material) and another made in a similar
way (test instrument or unit under test)
- regular internal and external calibration
checks must be performed on
equipment (pipettes, pH meter)
Three Phases of Laboratory Practice
Pre-Analytical Strategies
- traceability of results (relating the control
result w/the standard)
- instituting an associated feedback
network that confers error identification
- availability of quality system
- employing educated, trained and skilled
staff
- adequate training procedures for staff
and patients
correct registration and data input
- appropriateness of samples
- correct labelling of samples
- good transport conditions
- compliance with policy and procedure
Analytical Strategies
- traceability of results (relating the control
result w/the standard)
- proficiency testing
- use of machines that are suitably
maintained and calibrated
- operating with validated laboratory
methods
- assay precision and accuracy
- analytical sensitivity and specificity
- diagnostic sensitivity and specificity
- turnaround time
Post Analytic Strategies
- dispatching lab. Results to their rightful
owners
- application of corrective actions in the
event of errors or mistakes
- comprehensive record keeping
- effective documentation and reporting
procedures
 - unbiased and efficient client complaints
service
- efficient internal audit and review
procedures
- accuracy and clarity of laboratory results
- client interaction and consultation
Classification of Clinical Laboratories
Classification by ownership
Government - operated and maintained,
partially or wholly, by the national government, a
local government unit (provincial, city or
municipal), any other political unit or any
department, division, board or agency thereof
Private - Owned, established and operated by
any individual, corporation, association or
organization
Classification by Function
Clinical Pathology - includes Clinical
Chemistry, Hematology, Immunohematology,
Microbiology, Immunology, Clinical Microscopy,
Endocrinology, Molecular Biology, Cytogenetics,
Toxicology and Therapeutic drug monitoring and
other similar disciplines
Anatomic Pathology - includes surgical
pathology, Immunohistopathology, Cytology,
Autopsy, Forensic Pathology and Molecular
Pathology
Classification by Institutional Character
Institution based - a laboratory that operates
within the premises and as part of an institution
such as but not limited to hospital, medical clinic,
school, medical facility for overseas workers and
seafarers, birthing home, psychiatric facility,
drug rehabilitation center
Free-Standing - a laboratory that does not form
part of any other institution
Classification by Service Capability
General Clinical Laboratory
Primary Category - Provides the following
minimum service capabilities:
- Hematology (complete blood count)
includes hemoglobin mass
concentration, Erythrocyte volume
fraction (hematocrit), Leukocyte number
concentration (WBC count), and
Leukocyte type number fraction
(differential count)
- Qualitative Platelet Determination
- Routine Urinalysis
- Routine Fecalysis
- Blood typing (for hospital based)
Secondary Category - provides the minimum
service capabilities of a primary category
laboratory plus the following:
- Routine Clinical Chemistry - includes
blood glucose substance concentration,
Blood uric acid concentration, Blood
creatinine concentration, Blood total
cholesterol concentration
- Quantitative Platelet determination
- Crossmatching for hospital based
- Gram staining for hospital based
- KOH for hospital based
Tertiary Category - Provides the minimum
service capabilities of a secondary category
laboratory plus the following:
- Special Chemistry
- Special Hematology including
coagulation procedures
- Immunology( culture and sensitivity)
Limited Service Capability (for institution
based-only) – provides the laboratory tests
required for a particular service in institutions
such as but not limited to dialysis centers and
social hygiene clinics.
Special Clinical Laboratory - a laboratory that
offers a highly specialized laboratory services
that are usually not provided by a general clinical
laboratory.
Accreditation of clinical laboratories in the
Philippines started with the passage of the
clinical laboratory law in 1965 through the
Bureau of Research and Laboratories (BRL)
which is referred to as the Bureau of Health
Facilities at present.
Pls. refer to A.O. 0027 s. 2007 DOH (Revised
Rules and Regulation Governing the
Licensure and Regulation of Clinical - preparations and standardization of
Laboratories in the Philippines) reagents, standards, stains and others,
provided such reagents, standards,
Specifically focus on the following: stains and others are exclusively for the
- Specific and general guidelines use of their laboratory;
- Procedural guidelines - clinical laboratory quality control;
- Violations and investigation of - collection and preservation of
complaints and penalty specimens

Minimum Required Course

The medical technology course shall be at least

four years, including a 12-month satisfactory
internship in accredited laboratories, and shall
include the following subjects:

English, Biochemistry, Spanish, Gross Anatomy,

Social Science, Histology, General Zoology
Professional Certification of Clinical Physiology, Botany Clinical Parasitology,
Laboratory Employees (Medical Mathematics General Pathology, College
Technologists) Physics, Microbiology, General Chemistry,
Biostatistics, Qualitative Chemistry, Quantitative
Pls. refer to R.A. 5527 Philippine Medical Chemistry Clinical Laboratory Methods including
Technology Act of 1969 hematology, serology, blood banking, clinical
microscopy, applied microbiology,
Practice of Medical Technology histopathologic techniques, and cytotechnology
- a person shall be deemed to be in the
practice of medical technology within the Examination
meaning of this Act, who shall for a fee,
salary or other compensation or reward Except as otherwise specifically allowed under
paid or given directly or indirectly the provision of this Act, all applicants for
through another, renders any of the registration as medical technologist shall be
following professional services for the required to undergo written examination which
purpose of aiding the physician in the shall be given by the Board annually in the
diagnosis, study and treatment of greater Manila area, Cebu, and Davao during
diseases and in the promotion of the month of August or September on such days
health in general and places as the Board may
- examination of tissues, secretions and designate. Written notices of such examination
excretions of the human body and body shall be published in at least three newspapers
fluids by various electronic, chemical, of national circulation by the Secretary of the
microscopic, bacteriologic, hematologic, Board of least thirty days prior to the date of
serologic, immunologic, nuclear, and examination.
other laboratory procedures and
techniques either manual or automated;-
- blood banking procedures and Qualification for Examination.
techniques;
- parasitologic, Mycologic and Every applicant examination under this Act,
Microbiologic procedures and shall, prior to the date thereof, furnish the Board
techniques; satisfactory proof that he or she: a. Is in good
- histopathologic and Cytotechnology; health and is of good moral character; b. Has
provided that nothing in this paragraph completed a course of at least four (4) years
shall inhibit a duly registered medical leading to the degree of Bachelor of Science in
laboratory technician from performing Medical Technology or Bachelor of Science in
histopathologic techniques and Public Health conferred by a recognized school,
procedures. college or university in accordance with this
Decree or having graduated from some other
profession and has been actually performing
medical technology for the last five (5) years
prior to the date of the examinations, if such
performance began prior to June 21, 1969.
Scope of Examination
The examination questions shall cover the
following
subjects with their respective relative weights:
Clinical
Chemistry ......................................................
20%
Microbiology
Parasitology ...................................... 20%
Hematology .........................................................
...... 20%
Blood Banking
Serology ......................................... 20%
Clinical Microscopy (Urinalysis and
other body fluids) ...................................
………......... 10%
Histopathologic Techniques,
Cytotechnology, Medical
Technology Laws, Related
Laws and its implementing
rules, and the Code of Ethics ........................
……….. 10%
The Board shall prepare the schedule of
subjects for examination and to submit the same
to the Commissioner of the Professional
Regulation Commission for publication at least
thirty (30) days before the date of examination.
The Board shall compute the general average of
each examinee according to the above-
mentioned relative weights of each subject.
Provided, however, that the Board may change,
add to or remove from the list of subjects or
weights above as progress in the science of
Medical Technology may require, subject to the
prior approval of the Professional Regulation
Commission, and publication of the change or
amendment at least three (3) months prior to the
date of examination in which the same is to take
effect.
Report of Rating
The Board shall, within one hundred and twenty
days after the date of completion of the
examination, report the result thereof to the
Commissioner of Civil Service, who shall submit
such result to the President of the Philippines for
approval.
Oath Taking
All successful examinees shall be required to
take a professional oath before the Board or
before any person authorized to administer
oaths prior to entering upon the practice of
medical technology in the Philippines.
Issuance of Certificate of Registration
Every applicant who has satisfactorily passed
the required examination for medical
technologist shall be issued a certificate of
& registration as such: Provided, That no such
certificate shall be issued to any successful
applicant who has not attained the age of
twenty-one (21) years. All certificate shall be
& signed by the members of the Board and by the
Commissioner of the Professional Regulation
Commission. The duly registered medical
technologists shall be required to display his
certificate of registration in the place where he
works. Provided, that upon application filed and
the payment of the required fee of one hundred
and fifteen pesos (P115.00) the Board shall
issue a certificate of registration as medical
technologist without examination to persons who
have been graduated with Bachelor of Science
in Medical Technology/Bachelor of Science in
Public Health in duly recognized schools of
medical technology in the Philippines or in any
foreign country, Provided, That in case of the
latter, the standard of medical technology
education is substantially the same as ours, and
in addition shall have been in the practice of
medical technology for at least three (3) years
prior to the filing of the application in laboratories
in the Philippines duly accredited by the Bureau
of Research and Laboratories, Department of
Health, or in foreign countries if such
performance began prior to June 21, 1969 and
also to all other persons who having graduated
from other professions have been actually
performing medical technology practice for the
last eight (8) years prior to filing of the
application, Provided, that such performance
began prior to June 21, 1969. Provided, further,
that the Board shall likewise issue a certificate of
registration as medical laboratory technician
without examination to any person who upon
application and payment of the required fee of
fifty pesos (P500.00) show evidence satisfactory
to the Board that:
1. He or she passed the civil service
examination for medical technician given on
March 21, 1964; or
2. Has finished a two-year college course and
has at least one (1) year of experience as
medical laboratory technician, Provided, that for
every year of deficiency in college attainment
two (2) years of experience may be substituted;
Provided, further, that an applicant who has at
least ten (10) years of experience as medical
laboratory technician as of the date of approval
of this Decree regardless of his academic
attainment may qualify for registration without
examination; or
3. Has failed to pass the board examination for
medical technology but had obtained a general
rating of at least 70%. Provided, finally, that a
registered medical laboratory technician when
employed in the government shall have the
equivalent civil service eligibility not lower than
second grade.
Refusal to issue Certificate
The Board shall refuse to issue a certificate of
registration to any person convicted by the court
of competent jurisdiction of any criminal offense
involving moral turpitude, or any person guilty of
immoral or dishonorable conduct, or of unsound
mind, or incurable communicable disease, and
in such shall be given to the applicant a written
statement setting forth the reason for its action,
which statement shall be incorporated in the
record of the Board.
Marketing of Laboratory Services
Laboratory-Customer Relationship
Customer satisfaction is a major component of a
quality management system and a significant
focus in the International Organization for
standardization (ISO) Standards. Ultimately, the
laboratory produces a product-the test result for-
its customers. If the customers is not well
served, the laboratory is not achieving its
primary function.
Phil Crosby defined quality practice as meeting
the requirements of the customer. He applied
this practice to business and manufacturing but
it is equally important for a medical laboratory.
The medical laboratory needs to know who its
clients are, and understand clients’ needs and
requirements.
Medical laboratories have a range of customers
including patients, physicians, public health
agencies and the community.
It is the responsibility of the laboratory director to
ensure that the customers’ needs are met and
that there is customer satisfaction. The quality
manager is responsible for measuring the
degree of customer satisfaction, using surveys,
indicators and audits to take preventive and
corrective action.
All laboratory staff must understand the
importance of customers satisfaction.
Laboratory personnel must always interact with
customers in a way that is appropriate, proving
the needed information and being courteous.
Market Environment for Laboratory
Remember the four Ps of marketing:
- Product
- Price
- Place
- Promotion
What are the customer needs?
Who is the competition?
Do you have the right testing menu, equipment
and facilities?
Do you have enough personnel?
Do you have adequate financial resources?
Do you have what it costs to do a laboratory test
(test cost analysis)?
Implementing the Four Ps of Marketing
Price
With the high cost of healthcare, price is among
the highest concerns for prospective patients,
especially those without comprehensive health
insurance coverage. Providers should be aware
of any opportunities where they can offer the
best care at the lowest price. Many providers
offer simple tests, such as blood pressure
checks, cholesterol tests and HIV tests, at no
cost or reduced prices to raise patient
awareness of their services
Product
The patient's office visit is a small component of
the healthcare services that providers offer.
Providers must also deliver products to patients
that can improve their quality of life. Products
can include medications, testing kits and
orthopedic supplies, as well as on-call
"concierge" services.
Place
Vital services, no matter how inexpensive, must
be made available to patients to be effective. If
the services are only available in locations or
during hours where the patients cannot access
them, then the patients remain at risk and the
providers miss out on the opportunity to treat
them. Providers can seek out new locations,
expand operating hours, offer walk-in or same-
day appointments and reach out into local
communities to offer more access to healthcare
services and stand out from the competition.
Promotion
The promotion of a healthcare provider's service
is the most important aspect of the marketing
mix, yet it is often overlooked. Many larger
providers, such as major hospital chains or
pharmaceutical manufacturers, use mass media
to promote their services.
Market Research
Market research is the process of determining
the viability of a new service or product through
research conducted directly with potential
customers. Market research allows a company
to discover the target market and get opinions
and other feedback from consumers about their
interest in the product or service.
Market Proposal
A marketing proposal is a written document used
by marketers to communicate a project to a
client for consideration.
Traditionally the information provided by the
clinical scientist (clinical laboratory
scientist/medical technologist) workforce has
been essential in supporting the diagnosis and
treatment of patients. There is no doubt that their
expertise has provided information that
physicians require to make critical decisions
regarding their patient care responsibilities. In
1985, Strandjord estimated that 45% of medical
decision making relied on information generated
by laboratory tests. Today this number is
estimated to be 70%. The Mayo Health System
demonstrated that the laboratory contributes as
much as 94% of the objective data in a clinical
record.
Advances in Technology
Technological advances created revolutionary
changes in the way medicine and laboratory
medicine are practiced. The application of
molecular biology, using analysis of nucleic
acids and proteins to diagnose disease, assess
prognosis, and tailor therapy, has had a
profound impact on the laboratory, as well as
patient care, globally. For example, using nucleic
acid testing (NAT) for the detection of
transmissible pathogens allows earlier diagnosis
and treatment. The use of molecular diagnostics
to not only enhance diagnosis, but guide
treatment, has exploded. For example, in the
field of pharmacogenomics, testing can be used
before instituting therapy to determine if a
certain medication will be effective. Along with
this cutting-edge technology comes the need to
understand the costs and unique logistics
associated with the rapidly changing landscape
of Laboratory testing. Cellular-based therapies,
from the use of human stem cells to adipose
tissue, are making their way into the
marketplace and are the basis of a new industry
that impacts laboratory practice. Quality and
regulatory agencies are looking for ways to
ensure a safe efficacious product.
The Impact of Technology
The Electronic Medical Record
The motivation to use computerized information
systems in healthcare is driven by expectations
that such systems will improve the quality of
care, increase patient safety, and lower medical
costs. Yet there are many other factors to
consider about the use of an electronic medical
record (EMR). The EMR can undoubtedly
improve the legibility of entries and can
positively influence the organization of the
information in the record, making retrieval of
data more efficient. However, the EMR has been
blamed for interfering with the patient-physician lead to earlier treatment. Nucleic acid
relationship. Patients report feeling like doctors amplification testing has been introduced into
are so busy entering information into the blood donor screening over the last decade. The
computer that they hardly have time to discuss use of NAT has increased the sensitivity of
the patients’ concerns and plan of care. Many pathogen detection and allows for the earlier
physicians do not possess the computer skills to detection of transfusion-transmitted pathogens
become proficient at data entry and retrieval in than standard serologic tests allow.
the EMR. This maybe a cause of errors such as
documenting on the incorrect patient or choosing Miniaturization continues to change the way
an incorrect drug from a drop-down list. EMR tests are performed. The use of smaller “micro”
software developers continue to look for ways to components facilitates
reduce these common human errors through the POCT. As these components become smaller
use of templates and alerts to providers. and smaller, the number of analytes in a device
Through improved functionality and can increase, replacing larger analyzers. In
interoperability, the sharing of information to all some instances, laboratory results are available
providers of care for the patient will be improved, while the patient is still in the doctor’s office,
thereby facilitating patient care and safety. allowing results to rapidly and directly influence
the course of care. Developing smaller and
The electronic medical record versus the faster computers may lead the way to
paper record performing noninvasive tests, negating the
Electronic record Paper record need for blood specimens, especially using
Improved legibility Often not readable probes that can detect analytes
Patients feel the Patient and provider percutaneously. The concomitant reduction in
provider is ignoring can relate can discuss sample size is beneficial to the patient.
them the plan of care
Easier to locate Difficult to locate Due to changes and reductions in the laboratory
information-not reliant information work force, trying to do more with less is a
on memory dominant theme in laboratory medicine.
Maybe slow-providers Faster especially for Automation will continue to reduce personnel
may have a slow physicians not raised and laboratory costs. The use of robotics can
learning curve in technology era reduce the number of tasks that are currently
Allows easy synthesis Information is often done manually and thereby reduce the impact of
of information disparate and difficult human error. Track systems can help automate
to locate the process of testing a single sample for
Allows for easier, Paper must be copied multiple analytes, thereby improving efficiency
faster information and mailed or faxed and reducing personnel needs. By using a
sharing system of barcodes that identify patients and
Difficult for others to Easier for others to samples throughout the process, the risk of
follow read and follow misidentified patient samples has been reduced
Advances in Diagnostic Testing and may become a thing of the past. This form
of process control may have the ability to greatly
New disease patterns, changing demographics, reduce medical errors. Robotics is used for the
the aging population, emerging diseases, and delivery of supplies, samples, and blood
the threat of terrorism require innovative testing products in some hospitals.
methods. Nucleic acid testing, for example,
has truly revolutionized the way medicine is Point-of-care testing (POCT)
practiced. Instead of waiting days or weeks to
detect certain viruses in culture, amplifying small Microelectronics, microfabrication, and
amounts of genetic material in a specimen microcomputerization have revolutionized the
makes it possible to detect a pathogen within way that laboratory tests are performed. These
hours. Looking at changes in the genetic technologies allow test results to be
material of a tumor may improve the diagnosis of obtained in a matter of minutes or even
certain malignancies. There is also hope that seconds. POCT, or near-patient testing, has
identifying disease that is not yet long been touted as the technology that would
macroscopically evident at the genetic level will change patient management in the world of
managed care. The most obvious benefit of
POCT is decreased turnaround time (TAT).
The premise that near-patient testing would
radically change patient management under
managed care has not been substantiated.
Bickford’s research concluded that POCT had
no significant impact on hospital length of stay.
Receiving rapid results reflects patient status at
a given time and improves pharmacological
management. However, for physicians to act,
they must still wait for a complete manifest of
results. As new technologies for POCT evolve,
laboratory medicine professionals will continue
to question the accuracy and reliability of the
instruments and the results.
Advances in Genetic Testing and Molecular
Pathology
The Human Genome Project
Over the past 15 years, the Human Genome
Project (HGP), a joint program funded by the
Department of Energy (DOE) and the National
Institutes of Health (NIH), has completed the
sequencing of the total human genome. This
project yielded genetic maps and new
techniques to further genetic research and
clinical testing (107). The HGP’s significance is
vast and has far-reaching implications:
Pharmacogenetics Designing drugs specifically
modified to a person’s genetic make-up will be
important in the treatment of many genetic
diseases.
Agricultural genetics Engineering genetically
modified foods to be larger, more nutritious, and
pest-free.
Forensic genetics DNA-based human identity
testing can be used to convict or acquit an
individual accused of a crime.
Evolutional and anthropological genetics
Genetics is a major source of information about
the similarities and differences between humans
and other species.
Microarray technology Research during the
HGP has produced one technology, the
microarray, with the greatest potential for
disease detection and characterization.
Emerging technological advances in clinical
and anatomic pathology
A key component in the practice of anatomic and
clinical pathology in the future will be molecular
pathology. Practice protocols may rely on
molecular testing for diagnosis of disease as
well as the prognosis and treatment in the
laboratory disciplines such as hematology,
microbiology, histocompatibility, cytogenetics,
and surgical pathology.
Applications of genetic and molecular
pathology
Use of molecular diagnostics and genetic testing
is increasing from 6 to 25% annually (57). These
two fields generate unique problems for the
laboratory information system (LIS). The IT
needs include special nomenclature, the ability
to import/export images, and a database to
search karyotypes and to perform sequencing
and fragment analysis and place pressure on
LIS systems to adapt. Common techniques
used in molecular diagnostic testing include
laser capture microdissection, DNA
sequencing, PCR, fluorescent in situ
hybridization, micro- and macro-array
technology, and proteomics with mass
spectrometry.
A New Workforce
The emergence of clinical scientists as
consultants represents a natural evolutionary
growth in the role of the clinical laboratory
profession as it adapts to a changing
environment. This emerging role is being
fostered not only by the need to improve
laboratory test utilization but also by the
extraordinary growth of decentralized testing. In
addition, the vast growth of molecular testing,
not only for familiar analytes or organisms, but
for specific new and esoteric disease markers,
has created a need to improve communications
between clinical scientists and healthcare
providers.
The increasing complexity of the clinical
laboratory sciences is causing many physicians
to seek information and
to use interpretive guidelines, such as disease-
specific care maps, necessary to make optimal
and cost-effective use of the laboratory. These
guidelines were first evidenced following the
diagnosis-related group initiatives as a means to
reduce costs and provide more consistent
patient care.
It is important to recognize that clinical scientist (preanalytical) (analytical)
knowledge workers do both knowledge work and (postanalytical)
“manual work”. Performance of a laboratory
procedure constitutes manual work. Knowledge Test Test
work related to the laboratory procedure begins Test
with data analysis and the use of personal ordered → performed
intellectual capital (experience). Knowledge work → interpreted
also includes consultation with other clinical
service providers (pooled intellectual capital) and
electronically available intellectual capital.
The New Laboratory
This new workforce of clinical scientist
knowledge workers has some unique
The new laboratory model is an interactive
characteristics, which managers will need to
process, and the scope of laboratory services is
recognize and support.
broader. In this model, the focus is not only on
the quality of test data generated
- Knowledge workers are specialized
(process/analytical) but also on the clinical
- They are able to acquire and supply
appropriateness of test requests (input/pre
theoretical and analytical knowledge
analytical) and the correct interpretation of and
- They are learning-based, prepared
response to laboratory information (output/post
through formal education
analytical). The involvement of the laboratory in
- They exhibit the habit of lifelong learning
the entire total testing process will have a
- They are effective in teams
positive impact on patient outcomes, improve
- They seek meaning in their work and
the clinical relevance and value of the
advancement opportunities
laboratory’s service, and greatly enhance the
- They reach decisions by consensus, not
cost-effectiveness of the laboratory operation.
command
Input Process
Laboratory Paradigms
Output
(preanalytical) (analytical)
Before describing specific consultative roles, it is
(postanalytical)
useful to discuss the new interactive laboratory
and compare it to the
old, or traditional, laboratory. Test ← Test
← Test
The Old Laboratory ordered → performed
→ interpreted
Today, many clinical laboratories still operate
according to the traditional laboratory model,
which is a linear, unidirectional flow process of
one activity preceding the next activity. The
major concern in this model is the quality of the
test performance and the production features
and internal organization of the laboratory
(analytical phase). In the traditional model, the
focus is on the science and technology and
quality of test performance, and communication
is almost nonexistent prior to the test request or DATA PRIVACY ACT OF 2012 (R.A. 10173)
after the result is released. In this model, the
clinical laboratory is not concerned with clinical PROCESSING OF PERSONAL INFORMATION
appropriateness or interpretation of test results.
General Data Privacy Principles

Input Process The processing of personal information shall be

Output allowed, subject to compliance with the
requirements of this Act and other laws allowing
disclosure of information to the public and
adherence to the principles of transparency,
legitimate purpose and proportionality.
Personal information must be:
- Collected for specified and legitimate
purposes determined and declared
before, or as soon as reasonably
practicable after collection, and later
processed in a way compatible with
such declared, specified and legitimate
purposes only;
- Processed fairly and lawfully;
- Accurate, relevant and, where
necessary for purposes for which it is to
be used the processing of personal
information, kept up to date; inaccurate
or incomplete data must be rectified,
supplemented, destroyed or their further
processing restricted;
- Adequate and not excessive in relation
to the purposes for which they are
collected and processed;
- Retained only for as long as necessary
for the fulfillment of the purposes for
which the data was obtained or for the
establishment, exercise or defense of
legal claims, or for legitimate business
purposes, or as provided by law; and
- Kept in a form which permits
identification of data subjects for no
longer than is necessary for the
purposes for which the data were
collected and processed: Provided, that
personal information collected for other
purposes may lie processed for
historical, statistical or scientific
purposes, and in cases laid down in law
may be stored for longer
periods: Provided, further, that adequate
safeguards are guaranteed by said laws
authorizing their processing.
Criteria for Lawful Processing of Personal
Information
The processing of personal information shall be
permitted only if not otherwise prohibited by law,
and when at least one of the following conditions
exists:
- The data subject has given his or her
consent;
- The processing of personal information
is necessary and is related to the
fulfillment of a contract with the data
subject or in order to take steps at the
request of the data subject prior to
entering into a contract;
- The processing is necessary for
compliance with a legal obligation to
which the personal information controller
is subject;
- The processing is necessary to protect
vitally important interests of the data
subject, including life and health;
- The processing is necessary in order to
respond to national emergency, to
comply with the requirements of public
order and safety, or to fulfill functions of
public authority which necessarily
includes the processing of personal data
for the fulfillment of its mandate;
- The processing is necessary for the
purposes of the legitimate interests
pursued by the personal information
controller or by a third party or parties to
whom the data is disclosed, except
where such interests are overridden by
fundamental rights and freedoms of the
data subject which require protection
under the Philippine Constitution.
Sensitive Personal Information and
Privileged Information 
The processing of sensitive personal information
and privileged information shall be prohibited,
except in the following cases:
- The data subject has given his or her
consent, specific to the purpose prior to
the processing, or in the case of
privileged information, all parties to the
exchange have given their consent prior
to processing;
- The processing of the same is provided
for by existing laws and
regulations: Provided, That such
regulatory enactments guarantee the
protection of the sensitive personal
information and the privileged
information: Provided, further, That the
consent of the data subjects are not
required by law or regulation permitting
the processing of the sensitive personal
information or the privileged information;
 - The processing is necessary to protect
the life and health of the data subject or
another person, and the data subject is
not legally or physically able to express
his or her consent prior to the
processing;
- The processing is necessary to achieve
the lawful and noncommercial objectives
of public organizations and their
associations: Provided, That such
processing is only confined and related
to the bona fide members of these
organizations or their
associations: Provided, further,  That the
sensitive personal information are not
transferred to third parties: Provided,
finally, That consent of the data subject
was obtained prior to processing;
- The processing is necessary for
purposes of medical treatment, is
carried out by a medical practitioner or a
medical treatment institution, and an
adequate level of protection of personal
information is ensured; or
- The processing concerns such personal
information as is necessary for the
protection of lawful rights and interests
of natural or legal persons in court
proceedings, or the establishment,
exercise or defense of legal claims, or
when provided to government or public
authority.
Subcontract of Personal Information
- A personal information controller may
subcontract the processing of personal
information: Provided,  That the personal
information controller shall be
responsible for ensuring that proper
safeguards are in place to ensure the
confidentiality of the personal
information processed, prevent its use
for unauthorized purposes, and
generally, comply with the requirements
of this Act and other laws for processing
of personal information.
- The personal information processor
shall comply with all the requirements of
this Act and other applicable laws.
RIGHTS OF THE DATA SUBJECT
Rights of the Data Subject
The data subject is entitled to:
- Be informed whether personal
information pertaining to him or her shall
be, are being or have been processed;
- Be furnished the information indicated
hereunder before the entry of his or her
personal information into the processing
system of the personal information
controller, or at the next practical
opportunity:
1. Description of the personal information
to be entered into the system;
2. Purposes for which they are being or are
to be processed;
3. Scope and method of the personal
information processing;
4. The recipients or classes of recipients to
whom they are or may be disclosed;
5. Methods utilized for automated access,
if the same is allowed by the data
subject, and the extent to which such
access is authorized;
6. The identity and contact details of the
personal information controller or its
representative;
7. The period for which the information will
be stored; and
8. The existence of their rights, i.e., to
access, correction, as well as the right to
lodge a complaint before the
Commission.
Any information supplied or declaration
made to the data subject on these matters
shall not be amended without prior
notification of data subject: 
Provided, That the notification under subsection
(b) shall not apply should the personal
information be needed pursuant to
a subpoena or when the collection and
processing are for obvious purposes, including
when it is necessary for the performance of or in
relation to a contract or service or when
necessary or desirable in the context of an
employer-employee relationship, between the
collector and the data subject, or when the
information is being collected and processed as
a result of legal obligation;
Reasonable access to, upon demand, the
following:
1. Contents of his or her personal
information that were processed;
2. Sources from which personal
information were obtained;
 3. Names and addresses of recipients of
the personal information;
4. Manner by which such data were
processed;
5. Reasons for the disclosure of the
personal information to recipients;
6. Information on automated processes
where the data will or likely to be made
as the sole basis for any decision
significantly affecting or will affect the
data subject;
7. Date when his or her personal
information concerning the data subject
were last accessed and modified; and
8. The designation, or name or identity and
address of the personal information
controller;
Dispute the inaccuracy or error in the
personal information and have the personal
information controller correct it immediately
and accordingly, unless the request is
vexatious or otherwise unreasonable.
If the personal information have been corrected,
the personal information controller shall ensure
the accessibility of both the new and the
retracted information and the simultaneous
receipt of the new and the retracted information
by recipients thereof: Provided, That the third
parties who have previously received such
processed personal information shall he
informed of its inaccuracy and its rectification
upon reasonable request of the data subject;
Suspend, withdraw or order the blocking,
removal or destruction of his or her personal
information from the personal information
controller’s filing system upon discovery and
substantial proof that the personal information
are incomplete, outdated, false, unlawfully
obtained, used for unauthorized purposes or are
no longer necessary for the purposes for which
they were collected. In this case, the personal
information controller may notify third parties
who have previously received such processed
personal information; and
Be indemnified for any damages sustained due
to such inaccurate, incomplete, outdated, false,
unlawfully obtained or unauthorized use of
personal information.
Transmissibility of Rights of the Data
Subject
The lawful heirs and assigns of the data subject
may invoke the rights of the data subject for,
which he or she is an heir or assignee at any
time after the death of the data subject or when
the data subject is incapacitated or incapable of
exercising the rights as enumerated in the
immediately preceding section.
Right to Data Portability
The data subject shall have the right, where
personal information is processed by electronic
means and in a structured and commonly used
format, to obtain from the personal information
controller a copy of data undergoing processing
in an electronic or structured format, which is
commonly used and allows for further use by the
data subject. The Commission may specify the
electronic format referred to above, as well as
the technical standards, modalities and
procedures for their transfer.
SECURITY OF PERSONAL INFORMATION
Security of Personal Information
a. The personal information controller must
implement reasonable and appropriate
organizational, physical and technical
measures intended for the protection of
personal information against any
accidental or unlawful destruction,
alteration and disclosure, as well as
against any other unlawful processing
b. The personal information controller shall
implement reasonable and appropriate
measures to protect personal
information against natural dangers
such as accidental loss or destruction,
and human dangers such as unlawful
access, fraudulent misuse, unlawful
destruction, alteration and contamination
The determination of the appropriate level of
security under this section must take into
account the nature of the personal
information to be protected, the risks
represented by the processing, the size of
the organization and complexity of its
operations, current data privacy best
practices and the cost of security
implementation. Subject to guidelines as the
Commission may issue from time to time, the
measures implemented must include:
 1. Safeguards to protect its computer
network against accidental, unlawful or
unauthorized usage or interference with
or hindering of their functioning or
availability;
2. Security policy with respect to the
processing of personal information;
3. A process for identifying and accessing
reasonably foreseeable vulnerabilities in
its computer networks, and for taking
preventive, corrective and mitigating
action against security incidents that can
lead to a security breach; and
4. Regular monitoring for security breaches
and a process for taking preventive,
corrective and mitigating action against
security incidents that can lead to a
security breach.
The personal information controller must
further ensure that third parties processing
personal information on its behalf shall
implement the security measures required by
this provision.
may be delayed only to the extent necessary
to determine the scope of the breach, to
prevent further disclosures, or to restore
reasonable integrity to the information and
communications system.
1. In evaluating if notification is
unwarranted, the Commission may take
into account compliance by the personal
information controller with this section
and existence of good faith in the
acquisition of personal information.
2. The Commission may exempt a
personal information controller from
notification where, in its reasonable
judgment, such notification would not be
in the public interest or in the interests of
the affected data subjects.
3. The Commission may authorize
postponement of notification where it
may hinder the progress of a criminal
investigation related to a serious breach.
NOTE: Pls. include these in your further
readings and download R.A. 10173 and study
all the provisions therein.

The employees, agents or representatives of - SECURITY OF SENSITIVE PERSONAL

a personal information controller who are INFORMATION IN GOVERNMENT
involved in the processing of personal AND PENALTIES
information shall operate and hold personal
information under strict confidentiality if the
personal information are not intended for
public disclosure. This obligation shall
continue even after leaving the public
service, transfer to another position or upon
termination of employment or contractual
relations.

The personal information controller shall

promptly notify the Commission and affected
data subjects when sensitive personal
information or other information that may,
under the circumstances, be used to enable
identity fraud are reasonably believed to
have been acquired by an unauthorized
person, and the personal information
controller or the Commission believes (such
unauthorized acquisition is likely to give rise
to a real risk of serious harm to any affected
data subject. The notification shall at least
describe the nature of the breach, the
sensitive personal information possibly
involved, and the measures taken by the
entity to address the breach. Notification