Clin. Laboratory Laws and Lab Man Flashcards
(136 cards)
1
Q
Clinical Laboratory Law
A
Republic Act 4688
2
Q
Administrative order for the Rules and Regulations Governing the Establishment, Operation, and Maintenance of CL in the Philippines
A
Administrative Order #59 S. 2001
3
Q
Administrative order for the Revised Rules and Regulations Governing the Licensure and Regulation of CL in the Philippines
A
Administrative Order #27 S. 2007
4
Q
Administrative order for the New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
A
Administrative Order #37 S. 2021
5
Q
What are the Classification of Laboratories?
A
- By Function
- By Institutional Character
- By Service Capability
- By Ownership
6
Q
Classification of Laboratories: By function are?
A
- Clinical Pathology
- Anatomical Pathology
- Molecular Pathology
7
Q
It deals with the chemical and cellular analyses of blood and other body fluids
A
Clinical Pathology
8
Q
Examples under Clinical Pathology
A
Chemistry
Microscopy
Microbiology
ISBB
9
Q
It provides processing and examination of surgical specimens
A
Anatomical Pathology
10
Q
Examples under Anatomical Pathology
A
Surgical pathology
Cytopathology
Immunohistochemical techniques
Autopsy
Forensic pathology
11
Q
Its analysis of genes, SPECIFIC proteins, and other molecules
based on principles, techniques, and tools of molecular biology
A
Molecular Pathology
12
Q
Classification of Laboratories: By institutional character are?
A
- Hospital-based
- Non-hospital-based
13
Q
Hospital-based is now revised by the new AO to be called?
A
Institution-based
14
Q
Non-hospital-based is now revised by the new AO to be called
A
Free-Standing/ Independent lab
15
Q
Classification of Laboratories: By ownership are?
A
Government
Private
16
Q
It is operated and maintained, partially or wholly, by the national government (NGO), a local government unit (LGU)
A
Government
17
Q
It is privately owned, established, and operated with funds through donation, principal, investment, or other means, by any individual, corporation, association or organization
A
Private
18
Q
Human Resource is mainly composed of?
A
Head
Main Staff
Support Staff
Staffing
19
Q
The Head is?
A
Pathologist
20
Q
Under the head, there is a Visitation of:
Recommended:
Option (2 from the new AO):
A
Recommended: once a week
Option (2): at least 1 physical and 2 teleconferences/ calls per month
21
Q
The Main Staff is composed of?
A
RMTs
(CMT, Section head, MT staff)
22
Q
The Support Staff is composed of?
A
Lab Tech
Lab aide
Encoders
Receptionists
(sometimes filled by MTs, when UNDERSTAFFED)
23
Q
The Staffing is composed of?
A
(refer to notes)
but in Anatomic Pathology - at least 1 RMT per section
in Molecular Pathology - will depend on the service/s offered
24
Q
Laboratory Reports/ Results should have?
A
It shall have the NAME and SIGNATURE of the pathologist and RMT
25
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
26
In Physical Facilities, it should be more specific than the previous AOs
Space dimensions
27
In Physical Facilities, it is added due to pandemic
Sterilization units
28
In Physical Facilities, it is optional and usually found in tertiary institution-based lab
Conference rooms
29
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
30
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
31
In Material Specification, the floor should be
durable
wear-resistant
readily cleanable
32
In Material Specification, the floor can be tiles/ cement, smooth flooring, rubberized but
DO NOT USE WOOD
33
In Material Specification, the floor should be _____ especially ____
Non-slip surface
High-traffic areas
34
In Material Specification, the counters (workstations) should be ____, _____, _____, smooth and easy to clean
durable
non-porous (does not absorb moisture)
not support bacterial growth
35
In Material Specification, the counters should be _____
ceramic
DO NOT USE WOOD
36
In Material Specification, the counter of the sink is PREFERABLY ____ with ____
stainless steel
gooseneck faucet
37
In Material Specification, the door should have ____ for the main door/s of the clin. lab and clin. area
minimum clear opening
38
In Material Specification, the exit door shall be ____ and should not be _____
at least 900 mm
less than 800 mm
39
In Material Specification, the floor-to-ceiling height of rooms containing biosafety cabinets and fume hoods shall be _____
at least 2.60 meters
40
In Material Specification, ventilation for sections with machines should be?
Artificial air conditioning
41
In Material Specification, the ventilation minimum requirement is?
at least an exhaust fan each section
42
_____ in the laboratory is RECOMMENDED
directional airflow
43
This allows entry of air only; in one direction
Negative pressure
44
____, ____, ____ and other similar finishes SHALL BE AVOIDED
carpeting
fabrics
wood
45
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
46
BSL-3: +______ , BSL-4: + _____
anterooms
positive pressure suit
47
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
48
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
49
Guidelines for Equipment/ Instruments:
There shall be ____ and ____ equipment/machines/devices to provide the laboratory examination that the laboratory is licensed for.
available
operational
50
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
51
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)
52
Guidelines for Equipment/ Instruments:
There shall be ____ available reagents, glassware, and supplies for the laboratory examinations.
adequate
53
Guidelines for Equipment/ Instruments:
There shall be an ____ control of the reagents, glassware, and supplies.
inventory
54
Guidelines for Equipment/ Instruments:
The reagents, glassware, and supplies shall be ______ under the required conditions.
properly stored
55
TRUE or FALSE
Strong acid should be placed above a cabinet
FALSE
should NOT be placed above a cabinet
56
TRUE or FALSE
Do not combine basic with acid reagents
TRUE
57
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)
58
Validity of the License to operate
1 year
59
Application for LTO
thru DOH or Online Licensing Regulatory Systems (OLRS)
60
TRUE or FALSE
LTO must be displayed in the laboratory at all times
TRUE
61
If the applying laboratory is not fully compliant with the requirements, the laboratory shall be given ____
30 days to comply
62
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
63
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
64
Old confirmatory test for HIV
Western blot
65
New confirmatory as it is more effective
This uses ____ rapid kits
rHIVda
3
66
HIV confirmatory is now decentralized thru rHIVda allowing _____ to confirm
non-NRL
67
LABORATORIES EXEMPTED TO SECURE LICENSE TO OPERATE FROM BHFS
1. Laboratories for RESEARCH and TEACHING PURPOSES
2. National Reference Laboratories (NRL)
3. Physician’s Office Laboratory
4. Government laboratories
68
LABORATORIES EXEMPTED TO SECURE LICENSE TO OPERATE FROM BHFS must be registered to BHFS every ___
3 years
69
This is a special laboratories independently operating from clinical laboratories
Laboratories for RESEARCH and TEACHING PURPOSES
70
This is independently operating from the hospital laboratory
National Reference Laboratories (NRL)
71
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
72
Physician’s Office Laboratory is exempted to secure license to operate for _____
monitoring patients only POCT
73
Physician’s Office Laboratory is exempted to must secure license if:
1. Issue official laboratory results
2. Perform more than monitoring tests
3. Cater not only to physician’s own patients
74
This laboratory are performing microscopy works for malarial screening, AFB screening for STDs and PAP’s smear, (addtl. Kato Katz).
Government laboratories
75
NRL for HIV and STD
STD AIDS Cooperative Central Laboratory (SACCL) & RITM
76
NRL for TTIs
Research Institute for Tropical Medicine (RITM)
77
NRL for Virology
Research Institute for Tropical Medicine (RITM)
78
NRL for Malaria and TB
Research Institute for Tropical Medicine (RITM)
79
NRL for Mycology
Research Institute for Tropical Medicine (RITM)
80
NRL for Clinical Chemistry
Lung Center of the Philippines (LCP)
81
NRL for Water and Drug Testing
East Avenue Medical Center (EAMC)
82
NRL for Hematology
National Kidney and Transplant Institute (NKTI)
83
NRL for Automated CM
National Kidney and Transplant Institute (NKTI)
84
NRL for Immunohematology
National Kidney and Transplant Institute (NKTI)
85
NRL for Anatomic pathology
National Kidney and Transplant Institute (NKTI)
86
Clinical Laboratory with Satellite Laboratory in the same compound
1 LTO only
87
Satellite Lab outside the premises of the Central Laboratory
Separate LTO
88
It is licensed as part of the central laboratory but specimen collection is done mobile (moving)
Mobile laboratory
89
Mobile laboratory ______ and must operate only within a ______ from the central laboratory
only collects specimens
100 km radius
90
This operate within and under the management and supervision of the licensed laboratory of the hospital
Point of Care testing
91
Quality Assurance
External Quality Assurance and Internal Quality Control Programs
CQI
EQAP
92
There shall be provisions for the adequate and efficient disposal of the waste following guidelines of the DOH and the local government.
Waste Management
93
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
94
Domains of Laboratory Management
1. LABORATORY MANAGEMENT
2. SKILLS OF A MANAGER
3. GOALS VS OBJECTIVES
4. MANAGEMENT APPROACHES
5. LEADERSHIP STYLES
6. LABORATORY INFORMATION SYSTEM
7. COMPONENTS OF A COMPUTER
95
Working with and through people
Laboratory Management
96
Art of getting things done (achieving a goal) through people
Laboratory Management
97
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
98
Skills of a Manager that establish inter relation and can work with other people
Human skills
99
Skills of a Manager that uses problem-solving and creative thinking
Conceptual skills
100
It is a general statement of purpose of the organization
Goals
101
It is specific and measurable statement of the purpose of the org.
Objective
102
Objectives should be SMART
Specific,
Measurable
Attainable
Reliable
Time-bound
103
Management Approaches
Classical Approach
Behavioral Approach
Contingency Approach
104
Classical Approach
- Old approach
- Autocratic
- Hierarchical organizational structure
- Planning, organizing, and - controlling
Outcomes depend on the leader (leader-dependent)
105
Behavioral Approach
- Participative (leadership rather than dictation)
- Formation of teams/committee
- Leading, motivating (thru incentives), and communicating
- Leader hears out suggestions from members
106
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...)
107
Leadership Styles
Autocratic
Democratic
Permissive
Transactional
108
Dictatorship leadership style
Autocratic
109
Laissez-faire leadership style
Permissive
110
It is a self-centered and leader usually gives orders and should be obeyed without questions
It is also called the CLASSICAL APPROACH
Autocratic
111
It is a shared authority wherein the leader still gives orders but takes into consideration the inputs of his/her subordinates
Democratic
112
It is wherein the leader is more lenient and permissive and allows the subordinates to make decisions and take responsibility.
Permissive
113
It is not beneficial if subordinates/ members is not good/ too good (no unity)
Permissive
114
It is focused on the role of every employees and organizational
structures.
Transactional
115
Each will be given a task and only focus on their given role
Transactional
116
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
117
Components of a Computer
Hardware
Software
Peopleware
Interface
Network
118
It is the physical components of a computer
Hardware
119
It is the intangibles (programs and applications)
Software
120
It is the users and developers (persons)
Peopleware
121
It is a device or program enabling a user to communicate with a computer. (e.g., Bizbox)
Interface
122
The set of interconnected computers that through hardware and software technology works cooperatively for the purpose of information and application program exchange
Network
123
Personal Protective Equipment (PPE) consists of:
Laboratory Gowns/ Coats
Gloves
Face Protection
124
Laboratory Gowns/ Coats should be
long sleeved, closed front and fully buttoned
125
TRUE or FALSE
Lab gowns and coats can be worn outside the laboratory
FALSE
LAB GOWNS/COATS can be worn in the laboratory ONLY
126
Gloves of ____ should be used (not too snug and big)
proper size
127
Change gloves after
contact with each patient
128
TRUE or FALSE
Remove gloves before handling telephones, doorknobs and other uncontaminated laboratory equipment
TRUE
129
Use goggles especially when
handling chemicals with fumes
130
Always wear mask when
handling different specimen in the
laboratory
131
TRUE or FALSE
Full face shields made of lightweight transparent plastics are preferred means of facial protection
TRUE
132
NFPA Diamond
BLUE -
RED -
YELLOW -
WHITE -
BLUE - Health
RED - Fire
YELLOW - Instability
WHITE - Specific
133
Health Hazard
4
3
2
1
0
4 - Deadly
3 - Extreme Danger
2 - Hazardous
1 - Slightly Hazardous
0 - Normal Material
134
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
135
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
136
Specific Hazard
ACID
COR
OX
RH
W
ACID
ALK - Alkali
COR - Corrosive
OX - Oxidizer
Radiation Hazard
Use No Water
