Clin. Laboratory Laws and Lab Man Flashcards
Clinical Laboratory Law
Republic Act 4688
Administrative order for the Rules and Regulations Governing the Establishment, Operation, and Maintenance of CL in the Philippines
Administrative Order #59 S. 2001
Administrative order for the Revised Rules and Regulations Governing the Licensure and Regulation of CL in the Philippines
Administrative Order #27 S. 2007
Administrative order for the New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
Administrative Order #37 S. 2021
What are the Classification of Laboratories?
- By Function
- By Institutional Character
- By Service Capability
- By Ownership
Classification of Laboratories: By function are?
- Clinical Pathology
- Anatomical Pathology
- Molecular Pathology
It deals with the chemical and cellular analyses of blood and other body fluids
Clinical Pathology
Examples under Clinical Pathology
Chemistry
Microscopy
Microbiology
ISBB
It provides processing and examination of surgical specimens
Anatomical Pathology
Examples under Anatomical Pathology
Surgical pathology
Cytopathology
Immunohistochemical techniques
Autopsy
Forensic pathology
Its analysis of genes, SPECIFIC proteins, and other molecules
based on principles, techniques, and tools of molecular biology
Molecular Pathology
Classification of Laboratories: By institutional character are?
- Hospital-based
- Non-hospital-based
Hospital-based is now revised by the new AO to be called?
Institution-based
Non-hospital-based is now revised by the new AO to be called
Free-Standing/ Independent lab
Classification of Laboratories: By ownership are?
Government
Private
It is operated and maintained, partially or wholly, by the national government (NGO), a local government unit (LGU)
Government
It is privately owned, established, and operated with funds through donation, principal, investment, or other means, by any individual, corporation, association or organization
Private
Human Resource is mainly composed of?
Head
Main Staff
Support Staff
Staffing
The Head is?
Pathologist
Under the head, there is a Visitation of:
Recommended:
Option (2 from the new AO):
Recommended: once a week
Option (2): at least 1 physical and 2 teleconferences/ calls per month
The Main Staff is composed of?
RMTs
(CMT, Section head, MT staff)
The Support Staff is composed of?
Lab Tech
Lab aide
Encoders
Receptionists
(sometimes filled by MTs, when UNDERSTAFFED)
The Staffing is composed of?
(refer to notes)
but in Anatomic Pathology - at least 1 RMT per section
in Molecular Pathology - will depend on the service/s offered
Laboratory Reports/ Results should have?
It shall have the NAME and SIGNATURE of the pathologist and RMT
TRUE or FALSE
In cases of emergency and STAT of some laboratories, RMTs signature may NOT be required?
FALSE!!!!
In cases of emergency/ STAT of some laboratories, PATHOLOGISTS may NOT be required
In Physical Facilities, it should be more specific than the previous AOs
Space dimensions
In Physical Facilities, it is added due to pandemic
Sterilization units
In Physical Facilities, it is optional and usually found in tertiary institution-based lab
Conference rooms
In Material Specification, Walls should be structurally ____, ____, and ____ with a ____ rating as prescribed by the ____
sound
safe
sturdy
minimum fire-resistant
Fire code of the Philippines
In Material Specification, the interior walls or partitions and walls of the clinical working area and its sections shall be constructed from _____
WALL TO CEILING
In Material Specification, the floor should be
durable
wear-resistant
readily cleanable
In Material Specification, the floor can be tiles/ cement, smooth flooring, rubberized but
DO NOT USE WOOD
In Material Specification, the floor should be _____ especially ____
Non-slip surface
High-traffic areas
In Material Specification, the counters (workstations) should be ____, _____, _____, smooth and easy to clean
durable
non-porous (does not absorb moisture)
not support bacterial growth
In Material Specification, the counters should be _____
ceramic
DO NOT USE WOOD
In Material Specification, the counter of the sink is PREFERABLY ____ with ____
stainless steel
gooseneck faucet
In Material Specification, the door should have ____ for the main door/s of the clin. lab and clin. area
minimum clear opening
In Material Specification, the exit door shall be ____ and should not be _____
at least 900 mm
less than 800 mm
In Material Specification, the floor-to-ceiling height of rooms containing biosafety cabinets and fume hoods shall be _____
at least 2.60 meters
In Material Specification, ventilation for sections with machines should be?
Artificial air conditioning
In Material Specification, the ventilation minimum requirement is?
at least an exhaust fan each section
_____ in the laboratory is RECOMMENDED
directional airflow
This allows entry of air only; in one direction
Negative pressure
____, ____, ____ and other similar finishes SHALL BE AVOIDED
carpeting
fabrics
wood
Equipment and Instruments (minimum requirement per category) for PRIMARY Clinical Labs
Centrifuge (Clinical and Microhematocrit)
Hemocytometer
Microscope with OIO
Hemoglobinometer or its equivalent
Differential blood cell counter or its equivalent
BSL-3: +______ , BSL-4: + _____
anterooms
positive pressure suit
Equipment and Instruments (minimum requirement per category) for SECONDARY Clinical Labs
PRIMARY (+)
Refrigerator
Photometer or its equivalent
Water-bath or its equivalent
Timer or its equivalent
Equipment and Instruments (minimum requirement per category) for TERTIARY Clinical Labs
SECONDARY (+)
Incubator
Balance (triple beam, analytical)
Rotator
Serofuge and its equivalent
Autoclave and drying oven
BSC or its equivalent
Guidelines for Equipment/ Instruments:
There shall be ____ and ____ equipment/machines/devices to provide the laboratory examination that the laboratory is licensed for.
available
operational
Guidelines for Equipment/ Instruments:
There shall be a ____, ____, and ____ for every equipment/ machine/ instrument/ device in the DOH-licensed CL.
calibration (QC)
preventive maintenance
repair program
Guidelines for Equipment/ Instruments:
There shall be a ____ in case of equipment/ machines/ devices breakdown and malfunction. (Resorting to MANUAL PROCESSING)
contingency plan (backup plan)
Guidelines for Equipment/ Instruments:
There shall be ____ available reagents, glassware, and supplies for the laboratory examinations.
adequate
Guidelines for Equipment/ Instruments:
There shall be an ____ control of the reagents, glassware, and supplies.
inventory
Guidelines for Equipment/ Instruments:
The reagents, glassware, and supplies shall be ______ under the required conditions.
properly stored
TRUE or FALSE
Strong acid should be placed above a cabinet
FALSE
should NOT be placed above a cabinet
TRUE or FALSE
Do not combine basic with acid reagents
TRUE
REGULATION OF THE CLINICAL LABORATORIES
The ____, through the ___ shall exercise regulatory functions under the rules and regulations of the Act.
Department of Health (DOH)
Bureau of Health Facilities and Services (BHFS)
Validity of the License to operate
1 year
Application for LTO
thru DOH or Online Licensing Regulatory Systems (OLRS)
TRUE or FALSE
LTO must be displayed in the laboratory at all times
TRUE
If the applying laboratory is not fully compliant with the requirements, the laboratory shall be given ____
30 days to comply
Submitted complete applications that are not processed within _____ by the ____, in accordance with the current DOH guidelines, due to force majeure, shall automatically be granted the LTO, and a post-licensing visit shall be scheduled
20 days
HFSRB (BHFS) /CHD-RLED
Administrative order for only those with certification by DOH are allowed to secure a LTO as Rapid HIV Diagnostic Algorithm (rHIVda) Confirmatory Laboratory
AO 37 S. 2021 addition
Old confirmatory test for HIV
Western blot
New confirmatory as it is more effective
This uses ____ rapid kits
rHIVda
3
HIV confirmatory is now decentralized thru rHIVda allowing _____ to confirm
non-NRL
LABORATORIES EXEMPTED TO SECURE LICENSE TO OPERATE FROM BHFS
- Laboratories for RESEARCH and TEACHING PURPOSES
- National Reference Laboratories (NRL)
- Physician’s Office Laboratory
- Government laboratories
LABORATORIES EXEMPTED TO SECURE LICENSE TO OPERATE FROM BHFS must be registered to BHFS every ___
3 years
This is a special laboratories independently operating from clinical laboratories
Laboratories for RESEARCH and TEACHING PURPOSES
This is independently operating from the hospital laboratory
National Reference Laboratories (NRL)
National Reference Laboratories (NRL):
1. Provide laboratory ____ for confirmatory testing
2. ____ laboratory personnel and ____ other training institutions.
3. Maintain the _____
4. Perform ____ of reagents and diagnostic kits.
reference/referral services
Train; recognize
National External Quality Assessment Scheme (NEQAS)
technical evaluation
Physician’s Office Laboratory is exempted to secure license to operate for _____
monitoring patients only POCT
Physician’s Office Laboratory is exempted to must secure license if:
- Issue official laboratory results
- Perform more than monitoring tests
- Cater not only to physician’s own patients
This laboratory are performing microscopy works for malarial screening, AFB screening for STDs and PAP’s smear, (addtl. Kato Katz).
Government laboratories
NRL for HIV and STD
STD AIDS Cooperative Central Laboratory (SACCL) & RITM
NRL for TTIs
Research Institute for Tropical Medicine (RITM)
NRL for Virology
Research Institute for Tropical Medicine (RITM)
NRL for Malaria and TB
Research Institute for Tropical Medicine (RITM)
NRL for Mycology
Research Institute for Tropical Medicine (RITM)
NRL for Clinical Chemistry
Lung Center of the Philippines (LCP)
NRL for Water and Drug Testing
East Avenue Medical Center (EAMC)
NRL for Hematology
National Kidney and Transplant Institute (NKTI)
NRL for Automated CM
National Kidney and Transplant Institute (NKTI)
NRL for Immunohematology
National Kidney and Transplant Institute (NKTI)
NRL for Anatomic pathology
National Kidney and Transplant Institute (NKTI)
Clinical Laboratory with Satellite Laboratory in the same compound
1 LTO only
Satellite Lab outside the premises of the Central Laboratory
Separate LTO
It is licensed as part of the central laboratory but specimen collection is done mobile (moving)
Mobile laboratory
Mobile laboratory ______ and must operate only within a ______ from the central laboratory
only collects specimens
100 km radius
This operate within and under the management and supervision of the licensed laboratory of the hospital
Point of Care testing
Quality Assurance
External Quality Assurance and Internal Quality Control Programs
CQI
EQAP
There shall be provisions for the adequate and efficient disposal of the waste following guidelines of the DOH and the local government.
Waste Management
Penalties For Violations:
1st offense:
2nd offense:
3rd offense:
4th offense:
Written Stern warning
Thirty thousand pesos (P 30,000.00)
Fifty thousand pesos (P 50,000.00)
Revocation of DOH-LTO
Domains of Laboratory Management
- LABORATORY MANAGEMENT
- SKILLS OF A MANAGER
- GOALS VS OBJECTIVES
- MANAGEMENT APPROACHES
- LEADERSHIP STYLES
- LABORATORY INFORMATION SYSTEM
- COMPONENTS OF A COMPUTER
Working with and through people
Laboratory Management
Art of getting things done (achieving a goal) through people
Laboratory Management
Skills of a Manager that knows the job per se
(A school dean → once a teacher → knows teachers struggles → makes sure to give correct and fair workload distribution)
Technical skills
Skills of a Manager that establish inter relation and can work with other people
Human skills
Skills of a Manager that uses problem-solving and creative thinking
Conceptual skills
It is a general statement of purpose of the organization
Goals
It is specific and measurable statement of the purpose of the org.
Objective
Objectives should be SMART
Specific,
Measurable
Attainable
Reliable
Time-bound
Management Approaches
Classical Approach
Behavioral Approach
Contingency Approach
Classical Approach
- Old approach
- Autocratic
- Hierarchical organizational structure
- Planning, organizing, and - controlling
Outcomes depend on the leader (leader-dependent)
Behavioral Approach
- Participative (leadership rather than dictation)
- Formation of teams/committee
- Leading, motivating (thru incentives), and communicating
- Leader hears out suggestions from members
Contingency Approach
- No prior planning (do it first → if problems arise → adapt)
- Adapting to changing circumstances
- Some situations may affect the organizational behavior
- Manipulate some variables to improve behavior (management styles, employee output, etc…)
Leadership Styles
Autocratic
Democratic
Permissive
Transactional
Dictatorship leadership style
Autocratic
Laissez-faire leadership style
Permissive
It is a self-centered and leader usually gives orders and should be obeyed without questions
It is also called the CLASSICAL APPROACH
Autocratic
It is a shared authority wherein the leader still gives orders but takes into consideration the inputs of his/her subordinates
Democratic
It is wherein the leader is more lenient and permissive and allows the subordinates to make decisions and take responsibility.
Permissive
It is not beneficial if subordinates/ members is not good/ too good (no unity)
Permissive
It is focused on the role of every employees and organizational
structures.
Transactional
Each will be given a task and only focus on their given role
Transactional
A network of computers that incorporate all the needs of the laboratory and its customers from intake of specimens and requests, processing of the different tests until the release of results.
Laboratory Information System
Components of a Computer
Hardware
Software
Peopleware
Interface
Network
It is the physical components of a computer
Hardware
It is the intangibles (programs and applications)
Software
It is the users and developers (persons)
Peopleware
It is a device or program enabling a user to communicate with a computer. (e.g., Bizbox)
Interface
The set of interconnected computers that through hardware and software technology works cooperatively for the purpose of information and application program exchange
Network
Personal Protective Equipment (PPE) consists of:
Laboratory Gowns/ Coats
Gloves
Face Protection
Laboratory Gowns/ Coats should be
long sleeved, closed front and fully buttoned
TRUE or FALSE
Lab gowns and coats can be worn outside the laboratory
FALSE
LAB GOWNS/COATS can be worn in the laboratory ONLY
Gloves of ____ should be used (not too snug and big)
proper size
Change gloves after
contact with each patient
TRUE or FALSE
Remove gloves before handling telephones, doorknobs and other uncontaminated laboratory equipment
TRUE
Use goggles especially when
handling chemicals with fumes
Always wear mask when
handling different specimen in the
laboratory
TRUE or FALSE
Full face shields made of lightweight transparent plastics are preferred means of facial protection
TRUE
NFPA Diamond
BLUE -
RED -
YELLOW -
WHITE -
BLUE - Health
RED - Fire
YELLOW - Instability
WHITE - Specific
Health Hazard
4
3
2
1
0
4 - Deadly
3 - Extreme Danger
2 - Hazardous
1 - Slightly Hazardous
0 - Normal Material
Fire Hazard
4
3
2
1
0
4 - Below 73 degF
3 - Below 100 degF
2 - Below 200 degF
1 - Above 200 degF
0 - Will not burn
Instability Hazard
4
3
2
1
0
4 - May detonate
3 - Shock and heat may detonate
2 - Violent Chemical Change
1 - Unstable if Heated
0 - Stable
Specific Hazard
ACID
COR
OX
RH
W
ACID
ALK - Alkali
COR - Corrosive
OX - Oxidizer
Radiation Hazard
Use No Water
