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LAB MAN > Clin. Laboratory Laws and Lab Man > Flashcards

Clin. Laboratory Laws and Lab Man Flashcards

1
Q

Clinical Laboratory Law

A

Republic Act 4688

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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

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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

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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

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5
Q

What are the Classification of Laboratories?

A
  1. By Function
  2. By Institutional Character
  3. By Service Capability
  4. By Ownership
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6
Q

Classification of Laboratories: By function are?

A
  1. Clinical Pathology
  2. Anatomical Pathology
  3. Molecular Pathology
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7
Q

It deals with the chemical and cellular analyses of blood and other body fluids

A

Clinical Pathology

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8
Q

Examples under Clinical Pathology

A

Chemistry
Microscopy
Microbiology
ISBB

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9
Q

It provides processing and examination of surgical specimens

A

Anatomical Pathology

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10
Q

Examples under Anatomical Pathology

A

Surgical pathology
Cytopathology
Immunohistochemical techniques
Autopsy
Forensic pathology

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11
Q

Its analysis of genes, SPECIFIC proteins, and other molecules
based on principles, techniques, and tools of molecular biology

A

Molecular Pathology

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12
Q

Classification of Laboratories: By institutional character are?

A
  1. Hospital-based
  2. Non-hospital-based
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13
Q

Hospital-based is now revised by the new AO to be called?

A

Institution-based

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14
Q

Non-hospital-based is now revised by the new AO to be called

A

Free-Standing/ Independent lab

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15
Q

Classification of Laboratories: By ownership are?

A

Government
Private

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16
Q

It is operated and maintained, partially or wholly, by the national government (NGO), a local government unit (LGU)

A

Government

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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

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18
Q

Human Resource is mainly composed of?

A

Head
Main Staff
Support Staff
Staffing

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19
Q

The Head is?

A

Pathologist

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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

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21
Q

The Main Staff is composed of?

A

RMTs
(CMT, Section head, MT staff)

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22
Q

The Support Staff is composed of?

A

Lab Tech
Lab aide
Encoders
Receptionists
(sometimes filled by MTs, when UNDERSTAFFED)

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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

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24
Q

Laboratory Reports/ Results should have?

A

It shall have the NAME and SIGNATURE of the pathologist and RMT

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25
Q

TRUE or FALSE
In cases of emergency and STAT of some laboratories, RMTs signature may NOT be required?

A

FALSE!!!!
In cases of emergency/ STAT of some laboratories, PATHOLOGISTS may NOT be required

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26
Q

In Physical Facilities, it should be more specific than the previous AOs

A

Space dimensions

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27
Q

In Physical Facilities, it is added due to pandemic

A

Sterilization units

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28
Q

In Physical Facilities, it is optional and usually found in tertiary institution-based lab

A

Conference rooms

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29
Q

In Material Specification, Walls should be structurally ____, ____, and ____ with a ____ rating as prescribed by the ____

A

sound
safe
sturdy
minimum fire-resistant
Fire code of the Philippines

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30
Q

In Material Specification, the interior walls or partitions and walls of the clinical working area and its sections shall be constructed from _____

A

WALL TO CEILING

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31
Q

In Material Specification, the floor should be

A

durable
wear-resistant
readily cleanable

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32
Q

In Material Specification, the floor can be tiles/ cement, smooth flooring, rubberized but

A

DO NOT USE WOOD

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33
Q

In Material Specification, the floor should be _____ especially ____

A

Non-slip surface
High-traffic areas

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34
Q

In Material Specification, the counters (workstations) should be ____, _____, _____, smooth and easy to clean

A

durable
non-porous (does not absorb moisture)
not support bacterial growth

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35
Q

In Material Specification, the counters should be _____

A

ceramic
DO NOT USE WOOD

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36
Q

In Material Specification, the counter of the sink is PREFERABLY ____ with ____

A

stainless steel
gooseneck faucet

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37
Q

In Material Specification, the door should have ____ for the main door/s of the clin. lab and clin. area

A

minimum clear opening

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38
Q

In Material Specification, the exit door shall be ____ and should not be _____

A

at least 900 mm
less than 800 mm

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39
Q

In Material Specification, the floor-to-ceiling height of rooms containing biosafety cabinets and fume hoods shall be _____

A

at least 2.60 meters

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40
Q

In Material Specification, ventilation for sections with machines should be?

A

Artificial air conditioning

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41
Q

In Material Specification, the ventilation minimum requirement is?

A

at least an exhaust fan each section

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42
Q

_____ in the laboratory is RECOMMENDED

A

directional airflow

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43
Q

This allows entry of air only; in one direction

A

Negative pressure

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44
Q

____, ____, ____ and other similar finishes SHALL BE AVOIDED

A

carpeting
fabrics
wood

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45
Q

Equipment and Instruments (minimum requirement per category) for PRIMARY Clinical Labs

A

Centrifuge (Clinical and Microhematocrit)
Hemocytometer
Microscope with OIO
Hemoglobinometer or its equivalent
Differential blood cell counter or its equivalent

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46
Q

BSL-3: +______ , BSL-4: + _____

A

anterooms
positive pressure suit

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47
Q

Equipment and Instruments (minimum requirement per category) for SECONDARY Clinical Labs

A

PRIMARY (+)
Refrigerator
Photometer or its equivalent
Water-bath or its equivalent
Timer or its equivalent

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48
Q

Equipment and Instruments (minimum requirement per category) for TERTIARY Clinical Labs

A

SECONDARY (+)
Incubator
Balance (triple beam, analytical)
Rotator
Serofuge and its equivalent
Autoclave and drying oven
BSC or its equivalent

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49
Q

Guidelines for Equipment/ Instruments:
There shall be ____ and ____ equipment/machines/devices to provide the laboratory examination that the laboratory is licensed for.

A

available
operational

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50
Q

Guidelines for Equipment/ Instruments:
There shall be a ____, ____, and ____ for every equipment/ machine/ instrument/ device in the DOH-licensed CL.

A

calibration (QC)
preventive maintenance
repair program

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51
Q

Guidelines for Equipment/ Instruments:
There shall be a ____ in case of equipment/ machines/ devices breakdown and malfunction. (Resorting to MANUAL PROCESSING)

A

contingency plan (backup plan)

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52
Q

Guidelines for Equipment/ Instruments:
There shall be ____ available reagents, glassware, and supplies for the laboratory examinations.

A

adequate

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53
Q

Guidelines for Equipment/ Instruments:
There shall be an ____ control of the reagents, glassware, and supplies.

A

inventory

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54
Q

Guidelines for Equipment/ Instruments:
The reagents, glassware, and supplies shall be ______ under the required conditions.

A

properly stored

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55
Q

TRUE or FALSE
Strong acid should be placed above a cabinet

A

FALSE
should NOT be placed above a cabinet

56
Q

TRUE or FALSE
Do not combine basic with acid reagents

A

TRUE

57
Q

REGULATION OF THE CLINICAL LABORATORIES

The ____, through the ___ shall exercise regulatory functions under the rules and regulations of the Act.

A

Department of Health (DOH)
Bureau of Health Facilities and Services (BHFS)

58
Q

Validity of the License to operate

A

1 year

59
Q

Application for LTO

A

thru DOH or Online Licensing Regulatory Systems (OLRS)

60
Q

TRUE or FALSE
LTO must be displayed in the laboratory at all times

A

TRUE

61
Q

If the applying laboratory is not fully compliant with the requirements, the laboratory shall be given ____

A

30 days to comply

62
Q

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

A

20 days
HFSRB (BHFS) /CHD-RLED

63
Q

Administrative order for only those with certification by DOH are allowed to secure a LTO as Rapid HIV Diagnostic Algorithm (rHIVda) Confirmatory Laboratory

A

AO 37 S. 2021 addition

64
Q

Old confirmatory test for HIV

A

Western blot

65
Q

New confirmatory as it is more effective
This uses ____ rapid kits

A

rHIVda
3

66
Q

HIV confirmatory is now decentralized thru rHIVda allowing _____ to confirm

A

non-NRL

67
Q

LABORATORIES EXEMPTED TO SECURE LICENSE TO OPERATE FROM BHFS

A
  1. Laboratories for RESEARCH and TEACHING PURPOSES
  2. National Reference Laboratories (NRL)
  3. Physician’s Office Laboratory
  4. Government laboratories
68
Q

LABORATORIES EXEMPTED TO SECURE LICENSE TO OPERATE FROM BHFS must be registered to BHFS every ___

A

3 years

69
Q

This is a special laboratories independently operating from clinical laboratories

A

Laboratories for RESEARCH and TEACHING PURPOSES

70
Q

This is independently operating from the hospital laboratory

A

National Reference Laboratories (NRL)

71
Q

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.

A

reference/referral services
Train; recognize
National External Quality Assessment Scheme (NEQAS)
technical evaluation

72
Q

Physician’s Office Laboratory is exempted to secure license to operate for _____

A

monitoring patients only POCT

73
Q

Physician’s Office Laboratory is exempted to must secure license if:

A
  1. Issue official laboratory results
  2. Perform more than monitoring tests
  3. Cater not only to physician’s own patients
74
Q

This laboratory are performing microscopy works for malarial screening, AFB screening for STDs and PAP’s smear, (addtl. Kato Katz).

A

Government laboratories

75
Q

NRL for HIV and STD

A

STD AIDS Cooperative Central Laboratory (SACCL) & RITM

76
Q

NRL for TTIs

A

Research Institute for Tropical Medicine (RITM)

77
Q

NRL for Virology

A

Research Institute for Tropical Medicine (RITM)

78
Q

NRL for Malaria and TB

A

Research Institute for Tropical Medicine (RITM)

79
Q

NRL for Mycology

A

Research Institute for Tropical Medicine (RITM)

80
Q

NRL for Clinical Chemistry

A

Lung Center of the Philippines (LCP)

81
Q

NRL for Water and Drug Testing

A

East Avenue Medical Center (EAMC)

82
Q

NRL for Hematology

A

National Kidney and Transplant Institute (NKTI)

83
Q

NRL for Automated CM

A

National Kidney and Transplant Institute (NKTI)

84
Q

NRL for Immunohematology

A

National Kidney and Transplant Institute (NKTI)

85
Q

NRL for Anatomic pathology

A

National Kidney and Transplant Institute (NKTI)

86
Q

Clinical Laboratory with Satellite Laboratory in the same compound

A

1 LTO only

87
Q

Satellite Lab outside the premises of the Central Laboratory

A

Separate LTO

88
Q

It is licensed as part of the central laboratory but specimen collection is done mobile (moving)

A

Mobile laboratory

89
Q

Mobile laboratory ______ and must operate only within a ______ from the central laboratory

A

only collects specimens
100 km radius

90
Q

This operate within and under the management and supervision of the licensed laboratory of the hospital

A

Point of Care testing

91
Q

Quality Assurance

A

External Quality Assurance and Internal Quality Control Programs
CQI
EQAP

92
Q

There shall be provisions for the adequate and efficient disposal of the waste following guidelines of the DOH and the local government.

A

Waste Management

93
Q

Penalties For Violations:
1st offense:
2nd offense:
3rd offense:
4th offense:

A

Written Stern warning
Thirty thousand pesos (P 30,000.00)
Fifty thousand pesos (P 50,000.00)
Revocation of DOH-LTO

94
Q

Domains of Laboratory Management

A
  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
Q

Working with and through people

A

Laboratory Management

96
Q

Art of getting things done (achieving a goal) through people

A

Laboratory Management

97
Q

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)

A

Technical skills

98
Q

Skills of a Manager that establish inter relation and can work with other people

A

Human skills

99
Q

Skills of a Manager that uses problem-solving and creative thinking

A

Conceptual skills

100
Q

It is a general statement of purpose of the organization

A

Goals

101
Q

It is specific and measurable statement of the purpose of the org.

A

Objective

102
Q

Objectives should be SMART

A

Specific,
Measurable
Attainable
Reliable
Time-bound

103
Q

Management Approaches

A

Classical Approach
Behavioral Approach
Contingency Approach

104
Q

Classical Approach

A
  • Old approach
  • Autocratic
  • Hierarchical organizational structure
  • Planning, organizing, and - controlling
    Outcomes depend on the leader (leader-dependent)
105
Q

Behavioral Approach

A
  • Participative (leadership rather than dictation)
  • Formation of teams/committee
  • Leading, motivating (thru incentives), and communicating
  • Leader hears out suggestions from members
106
Q

Contingency Approach

A
  • 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
Q

Leadership Styles

A

Autocratic
Democratic
Permissive
Transactional

108
Q

Dictatorship leadership style

A

Autocratic

109
Q

Laissez-faire leadership style

A

Permissive

110
Q

It is a self-centered and leader usually gives orders and should be obeyed without questions
It is also called the CLASSICAL APPROACH

A

Autocratic

111
Q

It is a shared authority wherein the leader still gives orders but takes into consideration the inputs of his/her subordinates

A

Democratic

112
Q

It is wherein the leader is more lenient and permissive and allows the subordinates to make decisions and take responsibility.

A

Permissive

113
Q

It is not beneficial if subordinates/ members is not good/ too good (no unity)

A

Permissive

114
Q

It is focused on the role of every employees and organizational
structures.

A

Transactional

115
Q

Each will be given a task and only focus on their given role

A

Transactional

116
Q

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.

A

Laboratory Information System

117
Q

Components of a Computer

A

Hardware
Software
Peopleware
Interface
Network

118
Q

It is the physical components of a computer

A

Hardware

119
Q

It is the intangibles (programs and applications)

A

Software

120
Q

It is the users and developers (persons)

A

Peopleware

121
Q

It is a device or program enabling a user to communicate with a computer. (e.g., Bizbox)

A

Interface

122
Q

The set of interconnected computers that through hardware and software technology works cooperatively for the purpose of information and application program exchange

A

Network

123
Q

Personal Protective Equipment (PPE) consists of:

A

Laboratory Gowns/ Coats
Gloves
Face Protection

124
Q

Laboratory Gowns/ Coats should be

A

long sleeved, closed front and fully buttoned

125
Q

TRUE or FALSE
Lab gowns and coats can be worn outside the laboratory

A

FALSE
LAB GOWNS/COATS can be worn in the laboratory ONLY

126
Q

Gloves of ____ should be used (not too snug and big)

A

proper size

127
Q

Change gloves after

A

contact with each patient

128
Q

TRUE or FALSE
Remove gloves before handling telephones, doorknobs and other uncontaminated laboratory equipment

A

TRUE

129
Q

Use goggles especially when

A

handling chemicals with fumes

130
Q

Always wear mask when

A

handling different specimen in the
laboratory

131
Q

TRUE or FALSE
Full face shields made of lightweight transparent plastics are preferred means of facial protection

A

TRUE

132
Q

NFPA Diamond
BLUE -
RED -
YELLOW -
WHITE -

A

BLUE - Health
RED - Fire
YELLOW - Instability
WHITE - Specific

133
Q

Health Hazard
4
3
2
1
0

A

4 - Deadly
3 - Extreme Danger
2 - Hazardous
1 - Slightly Hazardous
0 - Normal Material

134
Q

Fire Hazard
4
3
2
1
0

A

4 - Below 73 degF
3 - Below 100 degF
2 - Below 200 degF
1 - Above 200 degF
0 - Will not burn

135
Q

Instability Hazard
4
3
2
1
0

A

4 - May detonate
3 - Shock and heat may detonate
2 - Violent Chemical Change
1 - Unstable if Heated
0 - Stable

136
Q

Specific Hazard
ACID
COR
OX
RH
W

A

ACID
ALK - Alkali
COR - Corrosive
OX - Oxidizer
Radiation Hazard
Use No Water

LAB MAN (3 decks)

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