Unit 3: RA 4688 Flashcards

1
Q

What is RA 4688?

A

Clinical Laboratory Law

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

In the clinical laboratory, a registered medical technologist can
function as: (3)

A

Chief Medical Technologist
Supervisor
Section Head

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

1 Registered Medical Technologist can supervise how many Medical Laboratory Technicians?

A

2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Enumerate the 4 importance of a clinical laboratory.

A
  1. Allows proper storage of specimen
  2. Aids in diagnosis of diseases
  3. Houses the necessary materials
  4. Provides services to the public in terms of lab procedures
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What are the two types of laboratory?

A

Hospital-based Laboratory
Free Standing Laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

UST Hospital Clinical Laboratory, East Avenue Clinical Lab, and
Providence Hospital Clinical Laboratory are all what type of laboratory?

A

Hospital-based Laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Hi Precision Laboratory, Pro Lab Diagnostics, and ACE Diagnostics are all what type of laboratory?

A

Free Standing Laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

True or False: CLinical laboratories should be regulated and licensed.

A

True

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Initially, laboratories were regulated and licensed under what?

A

Bureau of Research and Laboratories

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Who is now in charge of regulating and licensing laboratories?

A

Department of Health

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Bureau of Research and Laboratories was changed to?

A

Bureau of Health Facilities and Services

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Where is Bureau of Health Facilities and Services located?

A

San Lazaro

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What is the AO prescribing minimum standards for clinical laboratories to ensure the accuracy and precision of laboratory examinations to safeguard public health?

A

AO 2021-0037

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Who signed AO 2021-0037?

A

Dr. Francisco Duque

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Results are near the actual value.

A

Accuracy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Clinical laboratories are the “____________________” of health
because of its importance precisely in doing procedures producing laboratory results that aid physicians in diagnosis, treatment,
and maintenance of health or promotion of health in general.

A

nerve centers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Values are close to one another even after running the test several
times.

A

Precision

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

True or False: MedTechs are responsible for diagnosing diseases.

A

False

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

As per RA ________, diagnosis is not part of our practice as
medtechs.

A

RA 5527

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What is the Clinical Laboratory Law?

A

RA 4688

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

How many sections does RA 4688 have?

A

8 sections

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

When was RA 4688 approved?

A

June 18, 1966

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the department
of health, providing penalty for the violation thereof, and for other
purposes

A

RA 4688

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

What section is referred to below:
Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions
and radioactivity from humans or animals are analyzed for the
determination of the presence of pathologic organisms, processes
and/or conditions in the persons or animals from which they were
obtained, shall register and secure a license annually at the office
of the Secretary of Health: provided, that government hospital
laboratories doing routine or minimum laboratory examinations
shall be exempt from the provisions of this section if their services
are extensions of government regional or central laboratories.

A

Section 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Securing and registering a license at the Office of the Secretary
of Health must occur _____________.

A

annually

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

When are laboratories exempted from the requirement of registration?

A

If they are just an extension of government, regional, or central
laboratories

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

What section satisfies the condition below:
The Department of Health (DOH) satellite lab will operate under
their department.

A

Section 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

What section satisfies the condition below:
Satellite laboratory that is an extension of East Avenue Medical
Center, a government hospital, will operate under the license of a
government hospital.

A

Section 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

What section is referred to below:
It shall be unlawful for any person to be professionally in-charge
of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the
Secretary of Health, such authorization to be renewed annually.

A

Section 2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

What section is referred to below:
No license shall be granted or renewed by the Secretary of Health
for the operation and maintenance of a clinical laboratory unless
such laboratory is under the administration, direction and supervision of an authorized physician, as provided for in the preceding paragraph.

A

Section 2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

Manages and supervises the clinical laboratory

A

Pathologist

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

What are the two types of laboratory (in terms of specimen)?

A

Clinical Laboratory
Anatomic Laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

How many laboratories can a pathologist manage?

A

4 laboratories

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

How many blood banks can a pathologist manage?

A

2 blood banks

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

What section is referred to below:
The Secretary of Health, through the Bureau of Research and
Laboratories shall be charged with the responsibility of strictly
enforcing the provisions of this Act and shall be authorized to issue
such rules and regulations as may be necessary to carry out its
provisions.

A

Section 3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

Who shall be in charge with the responsibility of strictly enforcing
the provisions of this Act and shall be authorized to issue such
rules and regulations as may be necessary to carry out its provisions?

A

Office of the Secretary (Bureau of Research and Laboratories -
now: Bureau of Health Facilities and Services)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

What section is referred to below:
Any person, firm or corporation who violates any provisions of
this Act or the rules and regulations issued thereunder by the
Secretary of Health shall be punished with imprisonment for not
less than one month but not more than one year, or by a fine of not
less than one thousand pesos nor more than five thousand pesos,
or both such fine and imprisonment, at the discretion of the court.

A

Section 4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

According to Section 4, how long should the imprisonment for the
violation of the RA 4468 be?

A

not less than one month but not more than one year

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

According to Section 4, how much should the fine for the violation
of the RA 4468 be?

A

not less than 1000 but not more than 5000

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

What section is referred to below:
If any section or part of this Act shall be adjudged by any court of
competent jurisdiction to be invalid, the judgment shall not affect,
impair, or invalidate the remainder thereof.

A

Section 5

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

What section is referred to below:
The sum of fifty thousand pesos, or so must thereof as may be
necessary, is hereby authorized to be appropriated, out of any
funds in the National Treasury not otherwise appropriated, to carry
into effect the provisions of this Act.

A

Section 6

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

What section is referred to below:
All Acts or parts of Acts which are inconsistent with the provisions
of this Act are hereby repealed.

A

Section 7

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
42
Q

What section is referred to below:
This Act shall take effect upon its approval.

A

Section 8

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
43
Q

Enumerate the 6 old and amended implementing guidelines.

A
  1. AO No. 201, Series of 1973
  2. AO No. 209, Series of 1976
  3. AO No. 52, Series of 1983
  4. AO No. 49 - B, Series of 1988
  5. Executive Order No. 102, Series of 1999
  6. AO No. 59, Series of 2001
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
44
Q

What implementing guideline is described:
Redirecting the Functions & Operations of DOH

A

Executive Order No. 102, Series of 1999

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
45
Q

Rules & Regulations Governing The Establishment, Operation &
Maintenance of Clinical Laboratories in the Philippines

A

Administrative Order No. 59, Series of 2001

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
46
Q

Revised Rules and Regulations Governing the Licensure and
Regulation of Clinical Laboratories in the Philippines

A

Administrative Order No. 2007-0027

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
47
Q

Amendment to Administrative Order No. 2007-0027

A

Administrative Order No. 2007-0027-A

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
48
Q

Posting of Schedule of Fees for Laboratory and Other Diagnostic
Services of Hospitals and other Health Facilities

A

Administrative Order No. 2008-0002

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
49
Q

Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories

A

Administrative Order No. 2008-0007

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
50
Q

New Rules and Regulation Governing the Regulation of Clinical
Laboratories in the Philippines

A

ADMINISTRATIVE ORDER NO. 2021-0037

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
51
Q

Specific department of DOH in-charge of licensing and regulation
of all health facilities including Clinical Laboratories

A

Health Facilities and Services Regulatory Bureau
(formerly Bureau of Health Facilities and Services )

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
52
Q

This is in charge of all clinical laboratory licensing and related
concerns.

A

Health Facilities and Services Regulatory Bureau
(formerly Bureau of Health Facilities and Services )

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
53
Q

The necessity to review the current AO and to revise and update
the minimum standards and technical requirements for licensing
clinical laboratories in the Philippines is aligned with the main
objective of _______________.

A

RA 1123

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
54
Q

What is RA 1123?

A

Universal Health Care Act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
55
Q

This guarantees access to quality and affordable health products,
devices, facilities and services.

A

RA 11223 - Universal Health Care Act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
56
Q

Natural or juridical person who intends to operate a clinical laboratory

A

Applicant

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
57
Q

CHD means…

A

Center for Health Development

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
58
Q

Facility where tests are done on specimens from human body to
obtain information about health status of patient for prevention,
diagnosis and treatment of diseases

A

Clinical Laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
59
Q

Panic values originally described by Lundberg as “lifethreatening”
unless something is done promptly and for which some corrective
action could be undertaken

A

Critical Values

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
60
Q

Lundberg described critical values as “____________________”

A

life-threatening

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
61
Q

EQAP stands for…

A

External Quality Assessment Program

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
62
Q

The program where participating laboratories are given unknown
samples for analysis

A

External Quality Assessment Program

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
63
Q

Checklist used by regulatory officers during inspection visits to
evaluate compliance of clinical laboratory to minimum standards
and technical requirements

A

Assessment Tool

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
64
Q

ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL
LABORATORY

A

AO 2021-0037 Annex B1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
65
Q

EQUIPMENT/INSTRUMENTS/GLASSWARE/SUPPLIES/REAGENTS PER AREA OF ACTIVITY/SERVICE
CAPABILITY OF GENERAL CLINICAL LABORATORY

A

AO 2021-0037 Annex B2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
66
Q

PROHIBITED ACTS IN THE OPERATIONS OF CLINICAL LABORATORIES

A

AO 2021-0037 Annex C

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
67
Q

PLANNING AND DESIGN GUIDELINES FOR GENERAL CLINICAL LABORATORY

A

AO 2021-0037 Annex D1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
68
Q

CHECKLIST FOR REVIEW OF FLOOR PLANS GENERAL
CLINICAL LABORATORY

A

AO 2021-0037 Annex D2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
69
Q

GUIDELINES IN SECURING FOR REMOTE COLLECTION
PERMIT FOR CLINICAL LABORATORIES

A

AO 2021-0037 Annex E

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
70
Q

APPLICATION FORM FOR CERTIFICATE OF REGISTRATION
FOR RESEARCH AND TEACHING CLINICAL LABORATORY

A

AO 2021-0037 Annex F

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
71
Q

Corporate body or establishment organized for an educational,
medical, charitable or similar purpose

A

Institution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
72
Q

Issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the
requirements set forth

A

License

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
73
Q

LTO stands for…

A

License to Operate

74
Q

Individual, agency, partnership or corporation to whom the license
is issued and upon whom rests compliance

A

Licensee

75
Q

Laboratory testing unit that moves from testing site to another
testing site, or has a temporary testing location

A

Mobile Clinical Laboratory

76
Q

True or False: Mobile Clinical Laboratories move from one place
to another. It doesn’t need a base laboratory.

A

False

77
Q

Tests done in series on patients as a guide for treatment or
follow-up of their condition Monitoring Examinations

A

Monitoring Examinations

78
Q

NRL stands for…

A

National Reference Laboratory

79
Q

Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas

A

National Reference Laboratory

80
Q

The laboratories doing more complicated procedures. They all
have their own unique expertise.

A

National Reference Laboratory

81
Q

What is the National Reference Laboratory for Hematology, Immunohematology, Urinalysis?

A

NATIONAL KIDNEY AND TRANSPLANT INSTITUTE (NKTI)

82
Q

What is the National Reference Laboratory for Serology, HIV-positive samples, and other STD diseases?

A

STD/AIDS CENTRAL COOPERATIVE LABORATORY (SACCL)

83
Q

What is the National Reference Laboratory for Clinical Chemistry?

A

LUNG CENTER OF THE PHILIPPINES (LCP)

84
Q

NRL for Drug Testing, Water Microbiology, Micronutrient Assay

A

EAST AVENUE MEDICAL CENTER (EAMC)

85
Q

NRL for Microbiology and Parasitology

A

RESEARCH INSTITUTE OF TROPICAL MEDICINE (RITM)

86
Q

Who is the current director of the Research Institute of Tropical
Medicine?

A

Celia Carlos

87
Q

POL stands for…

A

Physician’s Office Laboratory

88
Q

Individual doctor’s office/clinic wherein laboratory examinations
are performed

A

Physician’s Office Laboratory

89
Q

POCT stands for…

A

Point of Care Testing

90
Q

Diagnostic testing at or near the site of patient care rather than in
clinical laboratory; includes bedside testing, outpatient and home
care

A

Point of Care Testing

91
Q

Basic, commonly requested tests in the laboratory, the results of
which are not required to be released immediately upon completion

A

Routine Tests

92
Q

Any testing site that performs laboratory examinations under the
administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory

A

Satellite Testing Site

93
Q

Done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure.

A

Stat Tests

94
Q

STAT is an abbreviation for “___________” which means immediately.

A

Statim

95
Q

What are the two classification of laboratories by ownership?

A

Government
Private

96
Q

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

A

Government Laboratory

97
Q

Owned, established and operated by any individual, corporation,
association or organization Private

A

Owned Laboratory

98
Q

Includes Clinical Chemistry, Hematology, Immunohematology,
Microbiology, Immunology, Clinical Microscopy, Endocrinology,
Molecular Biology, Cytogenetics, Toxicology and Therapeutic
Drug Monitoring and other similar disciplines

A

Clinical Pathology

99
Q

Includes Surgical Pathology, lmmunohistopathology, Cytology,
Autopsy, Forensic Pathology and Molecular Pathology

A

Anatomical Pathology

100
Q

What are the two types of laboratory according to function?

A

Clinical Pathology
Anatomical Pathology

101
Q

What are the two types of laboratory according to institutional
character?

A

Institution Based
Free-standing

102
Q

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

A

Institution Based

103
Q

A laboratory that does not form part of any other institution

A

Free-Standing Laboratory

104
Q

What are the four types of laboratory according to service capability?

A

Primary
Secondary
Tertiary
Limited Service Capability

105
Q

What type of laboratory is referred to below:
- Routine Hematology
Ë Complete Blood Count
Hemoglobin
Hematocrit
WBC Count
WBC Differential Count
Ï Qualitative Platelet Determination Ï Routine Urinalysis
Ï Routine Fecalysis
Ï Blood Typing - for hospital based

A

Primary Laboratory

106
Q

What type of laboratory is referred to below:
- Routine Clinical Chemistry
Ë Glucose
Ë Blood Urea Nitrogen
Ë Uric Acid
Ë Creatinine
Ë Total Cholesterol
Ï Quantitative Platelet Determination Ï Cross Matching - for hospital
based
Ï Gram Staining - for hospital based Ï KOH - for hospital based

A

Secondary Laboratory

107
Q

True or False: You may perform cross-matching, gram staining,
and potassium hydroxide test in a hospital-based secondary laboratory

A

True

108
Q

What are the tests may a hospital-based secondary laboratory
perform?

A

Cross-matching
Gram Staining
Potassium Hydroxide Test

109
Q

Only prioritize the training of interns into those that are really
important. Cross-matching, gram-staining, and KOH procedures
were one of those priority areas that were identified

A

Joint Memorandum Circular No. 1, s. 2021

110
Q

What type of laboratory is referred to below:
Ï Special Chemistry
Ï Special Hematology, including coagulation procedures
Ï Immunology
Ï Microbiology
Ë Culture and Sensitivity aerobic and anaerobic (for hospital based) aerobic or anaerobic (for non-hospital based)

A

Tertiary Laboratory

111
Q

Under DOH, who is in charge of inspection for clinical laboratories
internship per region?

A

Regional Quality Assurance Team

112
Q

True or False: In the region, if you are planning to admit interns for
internship, you have to apply for CHED recognition.

A

True

113
Q

Provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social
hygiene clinics

A

Limited Service Capability Laboratory

114
Q

A laboratory that offers highly specialized laboratory services that
are usually not provided by a general clinical laboratory

A

Special Clinical Laboratory

115
Q

True or False: LTO may be issued to clinical laboratories that do
not comply with the standards and technical requirements.

A

False

116
Q

True or False: Clinical laboratories exclusive for research and
teaching purposes shall be exempted from the licensing requirement but shall be required to register

A

True

117
Q

Enumerate the special laboratories required to register but not
licensed. (6)

A
  1. Assisted Reproduction Technology
  2. Molecular and Cellular Technology
  3. Molecular Biology
  4. Molecular Pathology
  5. Forensic Pathology
  6. Anatomic Pathology
118
Q

True or False: NRL shall be covered by license of clinical laboratory of the hospital.

A

True

119
Q

POL required to secure a LTO when it undertakes any or all of the
following activities: (2)

A
  1. Issues official laboratory results
  2. Cater not only to the physician’s own patients
120
Q

True or False: POCT (in hospital) required under management of
an anatomical laboratory.

A

False
(Clinical Laboratory)

121
Q

Who is the head of laboratory?

A

Pathologist

122
Q

A pathologist is certified by __________.

A

Philippine Board of Pathology

123
Q

They shall have administrative and technical supervision of the
activities in the laboratory.

A

Pathologist

124
Q

The specific guideline that states that there must be adequate
number of RMTs & other health professionals with documented
training and experience to conduct the laboratory procedures.

A

Human Resources

125
Q

The number of staff shall depend on: (2)

A

Workload
Services

126
Q

Human Resources shall have ________________ and
_________ at all levels of the organization

A

staff development and CPE

127
Q

For primary and secondary category clinical laboratories, there is
a need for __________ registered medtech in every section.

A

one

128
Q

What is the minimum working hours in a laboratory?

A

8 hours

129
Q

How many shifts are there in a laboratory?

A

3 shifts

130
Q

True or False: Interns must not do graveyard shifts.

A

False

131
Q

What is the specific guideline focusing on the working area, glasswares, reagents, supplies, and wastes of the laboratory?

A

Physical Resources

132
Q

True or False: A laboratory must be Well-ventilated, adequately
lighted, clean and safe.

A

True

133
Q

What is the minimum technical working area for a primary laboratory?

A

10 sq. meters

134
Q

What is the minimum technical working area for a secondary
laboratory?

A

20 sq. meters

135
Q

What is the minimum technical working area for a tertiary laboratory?

A

60 sq. meters

136
Q

What are the two quality control programs?

A

Internal QC
External QC

137
Q

Quality Control Program is a part of what guideline?

A

Physical Resources

138
Q

What form of quality control program is referred to below:
A designated NRL gives a certain sample which the NRL has
already tested and there is actually a value already determined
and then they give this sample to the laboratory. The laboratory
should run and get the exact value. If not, they will fail the EQAS.

A

External QC

139
Q

What is the criteria for renewal of license?

A

Satisfactory performance rating

140
Q

What is the basis for suspension/revocation of license?

A

Refusal to participate in EQAS-NRL

141
Q

For reporting, the report must bear the name and signature of: (2)

A

Pathologist
RMT

142
Q

True or False: An oral or written report without directive from the
pathologist or associate may be given for emergency cases.

A

True

143
Q

What files must be recorded?

A

All requests and reports of all specimens submitted and examined

144
Q

How long must the records be kept in file? =

A

At least a year

145
Q

How long must the records be kept in file (for anatomic and
forensic reports)?

A

Permanent

146
Q

True or False: Laboratory Fees should conform with the current
standards.

A

True

147
Q

When is the renewal of LTO for Non-hospital based?

A

First day of October to Last day of November

148
Q

Renewal of LTO is processed not later than _______ working days
after expiration date of LTO.

A

5

149
Q

True or False: LTO automatically cancels with notice when failed
to submit a duly accomplished application form and to pay proper
fee on or before the expiration date stated in license

A

False
(without notice)

150
Q

All organizations will have to apply under the _________ in order
to join the benefits and privileges of being an accredited professional organization (APO).

A

PRC

151
Q

Licensee shall ensure the following (2) for inspection of CHD
Director or authorized representative(s) at any reasonable time.

A
  1. accessibility of premises and facilities
  2. availability of all pertinent records for checking/review
152
Q

With any violation in the operation of a clinical laboratory, there
are sanctions in the form of ___________. (3)

A

fine
imprisonment
both

153
Q

Yes or No.
Refusal on any clinical lab to participate in external quality assurance project or program (EQAP) is a form of violation.

A

Yes

154
Q

Yes or No.
Issuance of a report, orally or in writing (in whole or part thereof)
which is in accordance with documented procedures is a form of violation.

A

No

155
Q

Yes or No.
Permitting unauthorized persons to perform technical procedures
is a form of violation.

A

Yes

156
Q

Licenses are __________________ (from one clinical laboratory
to another) and _______________ (not for sharing).

A

non-transferable & inalienable

157
Q

Violations will always depend on __________________.

A

Written Complaint

158
Q

Who shall investigate the complaint?

A

HFSRB/CHD/BHFS Director or representative

159
Q

True or False: HFSRB/CHD Director or representative shall suspend, cancel or revoke and may seek any law enforcement agency
to execute the closure of any erring lab when necessary.

A

True

160
Q

Penalties for clinical laboratories in a hospital will be governed by
__________________.
=

A

AO No. 2007-0022

161
Q

What administrative order is pertained to below:
“Violations under the One-Stop Shop Licensure System (OSSOLS) for Hospitals”
=

A

AO 2007 - 0022

162
Q

For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:
What is done for the first offense?

A

Stern Warning

163
Q

When was AO No. 2007 - 0022 implemented?

A

June 6, 2007

164
Q

For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:

What is done for the second offense?

A

30,000

165
Q

For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:
What is done for the third offense?

A

50,000

166
Q

For non-institution-based CL that are not under the One Stop
Shop Licensing System (OSSOLS), the following are the penalties
and sanctions that shall be imposed:
What is done for the fourth offense?

A

Revocation of DOH-LTO

167
Q

If offender is a firm or corporation, who shall be liable to the penalty
imposed?

A

Managing head and/or owner(s)

168
Q

Any person who operates a CL without securing the necessary DOH-PTC and corresponding DOH-LTO shall be issued a
________________ and shall pay the administrative penalty of
________________.

A

Cease-and-Desist Order (CDO); Fifty thousand pesos (Php
50,000.00).

169
Q

Guidelines in Securing a License to Operate a COVID-19 Testing
Laboratory in the Philippines

A

Administrative Order No. 2020-0014

170
Q

Amendment to the Administrative Order No. 2020-0014

A

Administrative Order No. 2020-0014-A

171
Q

Amendment to the Administrative Order No. 2020-0014-A

A

Administrative Order No. 2020-0014-B

172
Q

What are the two classification of COVID-19 laboratories according to ownership?

A

Government
Private

173
Q

This is owned, established and operated with funds through donation, principal, investment or other means by any individual
corporation, association or organization.

A

Private

174
Q

What are the two classification of COVID-19 laboratories according to institutional character?

A

Hospital Based
Non-hospital Based

175
Q

True or False: A COVID-19 Laboratory may be part of a general
clinical laboratory but with a designated room distinct from the
main laboratory.

A

True

176
Q

What is the minimum number of personnel for the COVID-19
laboratory?

A

7

177
Q

Enumerate the 7 personnel of a COVID-19 laboratory.

A

1 Pathologist
3 Analysts (3 MTs; 2 MTs & 1 Allied Health with Training)
1 Laboratory Aide
1 Receptionist
1 Encoder

178
Q

The personnel for COVID-19 laboratories must be trained in what
fields?

A

Biosafety and Biosecurity
Molecular Diagnostic Techniques

179
Q

Fit testing of respirator has ______% efficacy.

A

95%

180
Q

True or False: Performing a seal check when donning an N95
mask is optional.

A

False

181
Q

What is the temperature for refrigerator of reagents?

A

4 degrees Celsius

182
Q

What is the temperature for freezer of reagents?

A

-20 degrees Celsius