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MTLBE > (M) L1.1: RA 4688 - Clinical Laboratory Act of 1966 > Flashcards

(M) L1.1: RA 4688 - Clinical Laboratory Act of 1966 Flashcards

1
Q

What is the complete name of RA 4688?

A

An 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

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2
Q

T or F: RA 4688 only applies to laboratories located within the Greater Manila area

A

False (all clinical laboratories in the country regardless of physical location)

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3
Q

RA 4688 is applied to all laboratories that collect what kind of samples?

A

Human samples (to help in the diagnosis, prevention, treatment, and management of diseases and to promote personal and public health)

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4
Q

What kind of laboratories are excluded from RA 4688’s mandates, specifically the ones that work for DOH?

A

Government Clinical Laboratories

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5
Q

Government laboratories doing microscopy work for DOH are excluded from RA 4688 if they offer programs such as what? (not limited to)

Clue: There’s 4 in the manual

A
  1. Malaria screening
  2. Acid fast bacilli microscopy
  3. STD testing
  4. Cervical cancer screening using Pap smears
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6
Q

According to the amendment of AO 2007-0027-A, this laboratory is excluded from the requirement of securing a license to operate, what is this laboratory?

A

National Tuberculosis Reference Laboratory (NTRL) and its regional Reference Laboratories that perform TB cultures

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7
Q

T or F: Special labs for research, teaching, genetics, immunohematology, and molecular purposes are also included in the mandates of RA 4688

A

False (EXCLUDED; either they are regulated by other laws or that there is no regulation at all)

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8
Q

Special Clinical Laboratories that are not subject to AO’s are required to register in what agency?

A

Bureau of Health Facilities and Services (BHFS)

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9
Q

What 5 special clinical laboratories are not subject to Administrative Orders but are to be registered under BHFS?

A
  1. Assisted Reproduction Technology Labs
  2. Molecular Pathology
  3. Forensic Pathology
  4. Anatomic Pathology Labs
  5. Molecular Biology Labs
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10
Q

When was AO 2007-0027 dated?

A

August 22, 2007

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11
Q

What is the title of AO 2007-0027?

A

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

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12
Q

To what AO does the old AO 2007-0027 want to align its laboratory procedures to?

A

AO 2020-0047

Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines.

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13
Q

What is the title of AO 2020-0047?

A

“Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines”

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14
Q

The necessity to review and revise the AO’s relating to RA 4688 is aligned with the main objective of what other RA?

A

RA 11223 - Universal Health Care Act

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15
Q

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

A

RA 11223 - Universal Health Care Act

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16
Q

How long is given for existing licensed laboratories to comply with the new requirements of the current AO?

A

3 years from the date of effectivity

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17
Q

How long is given for existing licensed laboratories to fully offer the additional services for each category with corresponding personnel and equipment?

A

2 years from the date of effectivity

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18
Q

T or F: For new clinical laboratories, the new AO’s mandates are immediately applicable

A

True

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19
Q

What are the 3 classifications of labs based on functions?

A
  1. Clinical Pathology Lab
  2. Anatomic Pathology Lab
  3. Molecular Pathology Lab
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20
Q

What are the 2 classifications of labs based on institutional character?

A
  1. Institution-based
  2. Freestanding/Non institution-based
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21
Q

What are the 2 classifications of labs based on ownership?

A
  1. Government
  2. Private
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22
Q

What are the 4 classifications of labs based on service capabilities?

A
  1. General clinical laboratory
  2. Primary, Secondary, Tertiary, and Limited Service
  3. Special clinical laboratory
  4. Highly specialized lab services not provided in general clinical laboratories
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23
Q

T or F: Clinical laboratory categories cannot offer services beyond its minimum requirements even though staff, equipment, reagents, and supplies are complied

A

False (they can go beyond since it is merely the minimum)

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24
Q

What kind of facility is the limited-service clinical laboratory only allowed in?

A

Institution-based Facilities

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25
Q

The head of the clinical laboratory shall be a ______ that is certified by a professional organization

A

Pathologist

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26
Q

The pathologist who runs the clinical laboratory must be certified by a professional organization that is recognized as what?

A

Accredited Professional Organizations/Accredited Integrated Professional Organizations of the PRC

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27
Q

A pathologist who runs a laboratory must be certified in Clinical Pathology by what Board?

A

Board of Pathology of the Philippine Society of Pathologists

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28
Q

Tertiary clinical laboratories that offer anatomic pathology services must be headed by a pathologist who is certified in what?

A

Both Anatomic and Clinical Pathology

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29
Q

T or F: The head of a laboratory should also ensure the overall operations and maintenance of its satellite/mobile clinics

A

True

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30
Q

T or F: A limited laboratory should always be headed by a pathologist

A

False (not a default for a pathologist; because it depends on the services provided)

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31
Q

T or F: Genetics laboratories shall be headed by either a pathologist or licensed physician who is trained for its specialized services

A

True

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32
Q

For general clinical laboratories, the initial license must be applied where?

A

Center for Health Development (that has jurisdiction over the proposed general laboratory)

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33
Q

T or F: Special clinical laboratories are not required to secure a license to operate

A

True

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34
Q

T or F: Special laboratories can only be registered under BHFS

A

False (it can be to the Center for Health Development as long as it has jurisdiction over the proposed special laboratory)

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35
Q

For general clinical laboratories, license renewal must be done where?

A

CHD or HFSRB

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36
Q

T or F: Special laboratories can renew their licenses to both BHFS and/or CHD

A

True (as long as CHD has jurisdiction over the proposed special laboratory)

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37
Q

This allows for a single license to cover the ancillary and other facilities of the hospital where it was issued

A

One-Stop-Shop Licensure System for Hospital-based Clinical Laboratories (OSSLS)

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38
Q

Ancillary services of clinical laboratories includes what?

A
  1. Clinical Laboratory
  2. X-ray
  3. Pharmacy
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39
Q

The One-Stop-Shop Licensure System for Hospital-based Clinical Laboratories is based on what AO?

A

AO 2007-0021: Harmonization and Streamlining of the Licensing System for Hospitals

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40
Q

The DOH’s license to operate for labs is valid for how long?

A

1 year

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41
Q

The Cert. of Registration for laboratories exclusive for research and teaching shall be required to register with the DOH-HFSRB every how many years?

A

3 years

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42
Q

Lab requests and reports must be signed by who?

A

A pathologist and a medical technologist

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43
Q

T or F: Lab results for STAT must be made available

A

True

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44
Q

Clinical Pathology reports must be kept on file in the lab for at least how long?

A

1 year

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45
Q

Anatomic Pathology reports must be kept on file in the lab for how long?

A

PERMANENTLY

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46
Q

T or F: It is a violation if the laboratory is not subjected to participation in the EQAP (External Quality Assurance Program)

A

True

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47
Q

T or F: It is not a violation to transfer results from a send-out lab to the referring lab since they are connected

A

False (it is a violation)

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48
Q

A laboratory shall be sanctioned and penalized by WHAT AGENCY upon violation of guidelines?

A

Health Facilities and Services Regulatory Bureau (HFSRB)

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49
Q

A laboratory shall be sanctioned and penalized by WHO upon violation of guidelines?

A

CHD Director (Center for Health Development)

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50
Q

What does “committal” mean in terms of prohibited acts by the persons owning or operating the clinical laboratory and/or persons under their authority?

A

Commission/Omission

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51
Q

What sanction is given for the 1st offense?

A

Stern warning

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52
Q

What sanction is given for the 2nd offense?

A

30,000 pesos

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53
Q

What sanction is given for the 3rd offense?

A

50,000 pesos

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54
Q

What sanction is given for the 4th offense?

A

Revocation of DOH’s license to operate

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55
Q

A person operating a laboratory without securing the necessary DOH Permit to Construct and corresponding License to Operate shall be issued what order?

A

Cease and Desist Order (CDO)

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56
Q

What is the fee for a person operating a laboratory without securing the necessary DOH Permit to Construct and corresponding License to Operate?

A

50,000 pesos

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57
Q

What section of RA 4688 shall also be imposable aside from the administrative penalties provided in the AO?

A

Section 4

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58
Q

How long may the supervisor/owner be imprisoned for running a laboratory without a license?

A

1 month to 12 months

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59
Q

A clinical lab is required to have a quality assurance program by virtue of what memorandum pursuant to AO 2007-0027?

A

Department Memorandum No. 2009-0086 of the DOH

60
Q

Department Memorandum No. 2009-0086 of the DOH was issued when?

A

Feb. 3, 2009

61
Q

The quality assurance program shall include what 2 programs?

A

Internal and External Quality Control Program

62
Q

This program covers inputs, processes, and outputs as well as the practice of continuous quality improvement programs covering all aspects of lab performance

A

Internal Quality Assurance Program

63
Q

T or F: A lab is required to participate in the National External Quality Assessment Scheme

64
Q

The National External Quality Assessment Scheme (NEQAS) is administered by the designated _______

A

National Reference Laboratories (or other local/international external quality assurance programs recognized by the DOH)

65
Q

This is conducted to ensure that lab procedures are done in accordance with standards and that lab results are accurate and within the standard range for quality healthcare

A

National External Quality Assessment Scheme

66
Q

5 institutions were designated as National Reference Laboratories according to what order?

A

Department Order 393E s. of 2000

67
Q

When was Department Order 393E s. of 2000 issued?

A

November 14, 2000

68
Q

This National Reference Laboratory is for:

Infectious diseases (STDs), Hepatitis, HIV, and Syphilis

A

San Lazaro Hospital

69
Q

This National Reference Laboratory is for:

Dengue, Influenza, Tuberculosis and other Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, Measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and emerging diseases, and for confirmatory testing of blood units

A

Research Institute for Tropical Medicine

70
Q

This National Reference Laboratory is for:

HIV/AIDS, Hepatitis, Syphilis and other sexually transmitted infections

A

San Lazaro Hospital

71
Q

This National Reference Laboratory is for:

Environmental and Occupational Health; Toxicology and Micronutrient Assay, Drugs of Abuse, and Water Bacteriology

A

East Avenue Medical Center

72
Q

This National Reference Laboratory is for:

Hematology including Immunohematology, Immunopathology and Anatomic Pathology

A

National Kidney and Transplant Institute

73
Q

This National Reference Laboratory is for:

Biochemistry (Clinical Chemistry)

A

Lung Center of the Philippines

74
Q

The National Kidney and Transplant Institute being a reference laboratory for hematology, immunohematology, immunopathology, and anatomic pathology is consistent with what order?

A

Department Order 301-I s. of 1999

75
Q

What is the LATEST AO that follows the mandates of RA 4688?

A

AO 37 s. of 2021

(These rules and regulations shall serve as the new guidelines in the licensing of diagnostic clinical laboratories in the Philippines which shall ensure accountability of the laboratory on generation of accurate, precise, and reliable results in a timely manner through continuous compliance)

76
Q

A program where participating CL are given unknown samples for analysis; the quality of performance shall be assessed through the closeness of its results to the pre-determined value generated by the CL

A

External Quality Assurance Program (EQAP)

77
Q

Laboratory testing units capable of performing limited diagnostic procedures that move from one testing site to another as it has a DOH-licensed laboratory as its main one

A

Mobile Clinical Laboratory (MCL)

78
Q

An EQAP activity conducted by the NRL to assess the quality of performance and accuracy of the results of laboratories

A

National External Quality Assessment Scheme (NEQAS)

79
Q

Highest level of laboratory in the country performing highly complex procedures including confirmatory testing that is not commonly performed by lower level laboratories

A

National Reference Laboratories (NRL)

80
Q

This is the responsible entity for facilitating NEQAS to ensure compliance to quality standards for regulation and licensing of all laboratories in the country

A

National Reference Laboratories (NRL)

81
Q

A doctor’s office wherein CL examinations are performed for the purpose of monitoring the doctor’s patients only wherein NO official results shall be issued

A

Physician’s Office Laboratory (POL)

82
Q

T or F: The POL within the premises of a DOH-regulated facility shall be under the supervision of the CL

83
Q

Refers to diagnostic testing done at or near the site of patient care rather than in the lab; may be in the ER, operating suites, wards, and ambulances

A

Point of Care Testing (POCT)/Bedside or Near-patient testing

84
Q

Refers to the extension of the main CL located within the facility’s compound of premises which offer the same service capability as the main lab

A

Satellite Clinical Laboratory (SCL)

85
Q

Refers to CL tests that are either sent-out or outsourced to other DOH-licensed laboratories with the same or higher service capability

A

Referral Tests

86
Q

Classification by Ownership:
> Operated and maintained (partially or wholly) by the national government, an LGU, or any other political unit

A

Government

87
Q

Classification by Ownership:
> Established and operated with funds through donations, principal, investments or other means by individuals, corporations, associations, or organizations

88
Q

Classification by Institutional Character:
> Located within the premises and operates as part of the DOH licensed health facility

A

Institution-based (e.g. hospital-based)

89
Q

Classification by Institutional Character:
> Operates independently and is not attached to any DOH-licensed facility

A

Non-institution based (e.g. free-standing out-patient CL)

90
Q

Function/area of the lab wherein blood/body fluid analysis is commonly done in the areas of:
- Clinical Chemistry
- Immunohematology
- Medical Microbiology
- Immunology and Serology
- Hematology
- Parasitology
- Clinical Microscopy
- Toxicology
- Therapeutic Drug Monitoring and Endocrinology

A

Clinical Pathology

91
Q

Function/area of the lab that is concerned with the diagnosis of diseases through microscopic examination of tissues and organs:
- Histopathology
- Immunohistopathology
- Cytology
- Autopsy
- Forensic pathology

A

Anatomic Pathology

92
Q

Function/area in the lab that deals with the analysis of genes, proteins and, others to diagnose diseases or guide the prevention and treatment based on the principles of molecular biology

A

Molecular Pathology

93
Q

T or F: Tertiary laboratories are usually semi-automated

A

False (Fully automated; semi-automated is for secondary laboratories)

94
Q

This service provides 1 or 2 specialized tests that are not classified under anatomic or molecular pathology; it also applies to facilities offering DOH-program related tests

A

Limited Services

95
Q

This provides services for any of the ff. but not limited to cytology and histopathology

A

Clinical Laboratory for Anatomic Pathology Only

96
Q

This provides services for genetics, immuno/histopathology, and infectious disease

A

Clinical Laboratory for Molecular Pathology Only

97
Q

COVID-19 testing guidelines are described in this AO separate from the AO 37 s. of 2021

A

AO 14 s. of 2020

98
Q

A permit to construct shall be submitted to what department?

99
Q

RA 4688 was published on what date?

A

June 18, 1966

100
Q

How many sections does RA 4688 have?

101
Q

This definition is provided by AO 37 s. of 2021:
“A facility involved in pre-analytical, analytical, and post-analytical procedures; tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases”

A

Clinical Laboratory

102
Q

Section 1 constitutes?

A

Registration and Licensing

103
Q

Section 2 constitutes?

A

That the lab should be headed by a duly registered physician

104
Q

Section 3 constitutes?

A

That the Secretary of Health through the DOH shall issue the Rules and Regulations

105
Q

Section 3 states that the rules and regulations should be issued by who?

A

Secretary of Health through the Bureau of Research and Laboratories (BRL), now DOH

106
Q

Section 4 constitutes?

A

Punishment

107
Q

What is the maximum and minimum standard imprisonment range (acc. to Section 4)?

A

Not less than 1 month but not more than a year

108
Q

What is the maximum and minimum standard violation fine (acc. to Section 4)?

A

Not less than 1k but not more than 5k

109
Q

T or F: EQAP samples are infectious

A

False (non-infectious as these are used for testing only)

110
Q

What is the minimum number of correctly identified samples needed in order to get a satisfactory rate in the EQAP?

111
Q

T or F: POL staff are usually qualified RMTs

112
Q

A licensed physician (not a pathologist) can manage up to what levels of laboratories?

A

Primary and Secondary only; Tertiary laboratories are to be STRICTLY headed by a pathologist

113
Q

Inspection of labs are conducted every how many years?

114
Q

What 3 types of lab services ALWAYS have staff present in them no matter the shift?

A

Microscopy, Hematology, and Clinical Chemistry

115
Q

What 3 lab services only have staff present during the 1st shift (morning)?

A

Immunology/Serology, Microbiology, and Histopathology

116
Q

Why are staff not present during the 2nd and 3rd shifts for Immunology/Serology, Microbiology, and Histopathology?

A

Because there is a cut off period for sample processing (done via batch testing)

117
Q

What should be the total number of staff present for primary laboratories (w/o microbiology)?

A

8 (7 + 1 reliever)

118
Q

What should be the total number of staff present for primary laboratories (in government facilities)?

A

9 (8 + 1 reliever)

119
Q

What should be the total number of staff present for secondary laboratories?

A

12 (11 + 1 reliever)

120
Q

What should be the total number of staff present for tertiary laboratories (w/o histopathology)?

A

12 (11 + 1 reliever)

121
Q

What should be the total number of staff present for tertiary laboratories (for hospital-based)?

A

13 (12 + 1 reliever)

122
Q

If an RMT wants to specialize in HIV testing, they should get a certificate of proficiency from?

A

STD-AIDS Central Cooperative Laboratory in San Lazaro Hospital

123
Q

If an RMT wants to specialize in AFB microscopy, they should get a certificate of training on Direct Sputum Smear Microscopy from?

A

National Tuberculosis Reference Lab

124
Q

If an RMT wants to specialize in bacteriology, they should get a certificate of training from?

A

Research Institute for Tropical Medicine and other recognized institutions

125
Q

If an RMT wants to specialize in malaria smear, they should get a certificate of training from?

A

Research Institute for Tropical Medicine

126
Q

A primary laboratory requires how much space in sq. meters?

127
Q

A secondary laboratory requires how much space in sq. meters?

128
Q

A tertiary laboratory requires how much space in sq. meters?

129
Q

This form is required for the construction of new CLs and for renovation or expansion of already existing CLs, including a change in ownership or transfer of location

A

Permit to Construct (PTC)

130
Q

This AO is known as the “Guidelines in the Application for DOH Permit to Construct (DOH-PTC)”

A

AO 2016-0042

131
Q

Any person, firm, or corporation desiring to establish, operate, and maintain a CL shall submit this to the HFSRB/CHD-RLED (Regulations, Licensing, and Enforcement Division) in accordance with current DOH guidelines

A

License to Operate (LTO)

132
Q

All lab processes are monitored by the directors/authorized representatives of which 2 organizations?

A

HFSRB and/or CHD

133
Q

T or F: An LTO is transferrable

134
Q

T or F: A new license must be applied if there are changes in ownership or transfer in location

135
Q

T or F: Different branches require different licenses despite being under the same ownership

136
Q

One must inform the DOH within how many days if there are changes in the name, ownership, or headship of the lab?

137
Q

This agency is responsible for disseminating regulatory policies, standards, and forms for information and guidelines of the DOH-CHDs

138
Q

This agency shall submit quarterly reports on suspensions, revocations, and cease and desists orders issued on the CL

A

CHD-RLED (Regulatory, Licensing, and Enforcement Division)

139
Q

The CHD submits reports on suspensions, revocations, and cease and desists orders issued on the CL not later than what day of the following month after the covered quarter?

140
Q

These shall continuously comply with the rules and regulations, licensing standards, and requirements provided in this law

A

DOH-Licensed CLs

141
Q

In times of pandemics or public health events, DOH-licensed CLs are required to submit what?

A

Timely reports and data

142
Q

T or F: Licensed physicians not specializing in pathology can head a laboratory in far flung areas

143
Q

Lab requests shall be construed as a consultation between what 2 medical staff?

A

Physician and Pathologist

144
Q

T or F: All results/reports shall bear the name of the Pathologist only

A

False (RMT as well)

145
Q

Atleast how many RMTs are required per shift to cover lab operations?

MTLBE (30 decks)

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