mtl finalz Flashcards
Clinical Laboratory Law
REPUBLIC ACT 4688
Rules and Regulations Governing the Establishment, Operation, and Maintenance of CL in the Philippines
ADMINISTRATIVE ORDER #27 S. 2007
New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
ADMINISTRATIVE ORDER #37 S. 2021
deals with the chemical and cellular analyses of blood and other body fluids
Clinical Pathology
provides processing and examination of surgical specimens
Anatomical Pathology
Anatomical Pathology
Surgical pathology, Cytopathology, Immunohistochemical techniques, Autopsy, Forensic pathology
analysis of genes, SPECIFIC proteins, and other molecules based on principles, techniques, and tools of molecular biology (Administrative Order #)
Molecular Pathology
AO 37
Classification of laboratory by institutional character
- Hospital Based
- Non-hospital Based
Hospital Based (revised by newer AO as _____)
Institution-Based
Non-hospital Based (revised by newer AO as _____)
Free-Standing / independent lab
Classification of laboratory by ownership
Government
Private
Human resource of Clinical Lab
* Head:
o Visitation:
Recommended:
Option 2 (new AO):
* Main Staff:
* Support Staff:
* Staffing (minimum required staff per section & shift):
Anatomic Pathology –
Molecular Pathology –
- Head: Pathologist
o Visitation:
Recommended: once a week
Option 2 (new AO): at least 1 physical and 2 teleconference/call per month - Main Staff: Registered Medical Technologists (CMT, Section Head, MT staff)
- Support Staff: (sometimes are filled by MT, especially if UNDERSTAFFED)
o Laboratory technician, Laboratory aide, Encoders, Receptionists - Staffing (minimum required staff per section & shift):
Anatomic Pathology – at least 1 RMT per section
Molecular Pathology – will depend on the service/s offered
All laboratory reports shall bear the _______ of the ___ and ____
name and signature, pathologist and medical technologist
Physical Facilities
- Space dimensions:
- Sterilization units:
- Conference rooms:
more specific than the previous A.O.s,
added due to pandemic,
optional and usually found in tertiary institution-based lab
Interior walls or partitions and walls of the clinical working area and its sections shall be constructed from ______
WALL TO CEILING
Structurally sound, safe, and sturdy with a minimum ____ as prescribed by the
fire-resistant rating, Fire code of the Philippines
Floors should be _____ especially high-traffic areas (hallways)
Non-slip surface
Floors should be Tiles/cement, smooth flooring, ______; DO NOT USE _____
rubberized
WOOD
Sink is preferably ____ with ____
stainless steel with gooseneck faucet
The minimum clear opening for the main door/s of the clinical laboratory and the clinical working area and exit doors shall be at least _____ and should not be less than ____.
900mm and should not be less than 800mm.
The floor-to-ceiling height of rooms containing biosafety cabinets and fume hoods shall be at least _____.
2.60 meters
______ in the laboratory is RECOMMENDED
Directional airflow
Ventilation for sections w/machines
Artificial air conditioning
___, ___ ___, and other similar finishes shall be avoided
Carpeting, fabrics, wood,
BSL-3: +______ , BSL-4: + _____
anterooms, positive pressure suit
EQUIPMENT AND INSTRUMENTS FOR PRIMARY CLINICAL LABS
Centrifuge (Clinical and Microhematocrit),
Hemocytometer,
Microscope with OIO,
Hemoglobinometer or its equivalent,
Differential blood cell counter or its equivalent
EQUIPMENT AND INSTRUMENTS FOR SECONDARY CLINICAL LABS
PRIMARY (+):
Refrigerator,
Photometer or its equivalent,
Waterbath or its equivalent,
Timer or its equivalent
EQUIPMENT AND INSTRUMENTS FOR TERTIARY CLINICAL LABS
SECONDARY (+):
Incubator,
Balance (triple beam, analytical),
Rotator,
Serofuge and
its equivalent,
Autoclave and drying oven
BSC or its equivalent
There shall be _____, ____, AND ____ for every equipment/machine/instrument/device in the DOH-licensed CL.
a calibration (QC), preventive maintenance, and repair program
There shall be a ______ in case of equipment/machines/devices breakdown and malfunction
contingency plan (backup plan)
There shall be an ____ control of the reagents, glassware, and supplies
inventory
Validity of License to Operate
1 year validity
Application of LTO
thru DOH or Online Licensing Regulatory Systems (OLRS)
If the applying laboratory is not fully compliant with the LTO requirements, the laboratory shall be given _____ to comply
30 days
Submitted complete applications that are not processed within _____ by the HFSRB (BHFS) /CHD-RLED, 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
only those with certification by DOH are allowed to secure a LTO as Rapid HIV Diagnostic Algorithm (rHIVda) Confirmatory Laboratory
A.O. 37 s 2021 addition
old confirmatory for HIV
Western blot
new confirmatory as it is more cost effective (3 rapid kits)
rHIVda
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
Physician’s Office Laboratory is exempted to secure license to operate for _____
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
NRL for HIV and STD
STD AIDS Cooperative Central Laboratory (SACCL) & RITM
NRL for TTIs
Research Institute for Tropical Medicine (RITM)
NRL for Malaria and Tuberculosis
Research Institute for Tropical Medicine (RITM)
NRL for Virology
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 & 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)
licensed as part of the central laboratory
Mobile laboratory
Clinical Laboratory with Satellite Laboratory in the same compound
1 LTO only
Satellite Lab outside the premises of the Central Laboratory
– separate LTO
Mobile laboratory only ______ and must operate only within a ______ from the central laboratory
only collects specimens,
100 km radius
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
Penalties For Violations of Waste Management
* 1st offense:
* 2nd offense:
* 3rd offense:
* 4th offense:
- 1st offense: Written Stern warning
- 2nd offense: Thirty thousand pesos (Php 30,000.00)
- 3rd offense: Fifty thousand pesos (Php 50,000.00)
- 4th offense: 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
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
establish inter relation and can work with other people
Human skills
problem solving and creative thinking
Conceptual skills
SKILLS OF A MANAGER
- Technical skills
- Human skills
- Conceptual skills
a general statement of purpose of the organization
GOal
specific and measurable statement of the purpose of the org
Objectives
Objectives should be SMART
Specific, Measurable, Attainable, Reliable and 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
- Transactiona
dictatorship
Autocratic
laissez-faire
Permissive
self-centered and leader usually gives orders and should be obeyed without questions
Autocratic (dictatorship)
Leadership style classical approach
Autocratic (dictatorship
shared authority wherein the leader still gives orders but takes into consideration the inputs of his/her subordinates
Democratic
wherein the leader is more lenient and permissive and allows the subordinates to make decisions and take responsibility
Permissive (laissez-faire)
Not beneficial if subordinates/members is not good/ too good (no unity)
Permissive (laissez-faire)
Each will be given a task and only focus on their given role
Transactional
focused on the role of every employees and organizational structures
Transactional
A network of computers that incorporate all the needs of the laboratory and its customers from intake of specimen and requests, processing of the different tests until the release of results.
LABORATORY INFORMATION SYSTEM
COMPONENTS OF A COMPUTER
- Hardware
- Software
- Peopleware
- Interface
- Network
physical components of a computer
Hardware
intangibles (programs and applications)
Software
users and developers (persons)
Peopleware
a device or program enabling a user to communicate with a computer
Interface
The set of interconnected computers that through hardware and software technology work cooperatively for the purpose of information and application program exchange
Network
PERSONAL PROTECTIVE EQUIPMENT
- Laboratory Gown/Coats
- Gloves
- Face Protection
Laboratory Gown/Coats should be
Should be long sleeved, closed front and fully buttoned
Gloves of ____ should be used
PROPER SIZE
Change gloves after _____
contact with each patient
Use goggles especially when handling _______
chemicals with fumes
NFPA Diamond
BLUE -
RED -
YELLOW -
WHITE -
BLUE - Health Hazard
RED - Fire Hazard
YELLOW - Instability Hazard
WHITE - Specific Hazard
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
ALK - Alkali
COR - Corrosive
OX - Oxidizer
Radiation Hazard\
Use No Water
