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MT6313 (MT LAWS) > UNIT 3: RA 4688 (Clinical Laboratory Law) > Flashcards

UNIT 3: RA 4688 (Clinical Laboratory Law) Flashcards

1
Q

RA 4688 is also known as

A

Clinical Laboratory Law

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2
Q

How many sections are there in RA 4688?

A

8 sections

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3
Q

When was RA 4688 approved as a law?

passed by the 6th congress of the Philippines

A

June 18, 1966

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4
Q

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

A

RA 4688

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5
Q

What section is this?

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

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6
Q

What section is this?

  • 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.
  • 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

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7
Q

What section is this?

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

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8
Q

What section is this?

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

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9
Q

What section is this?

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

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10
Q

What section is this?

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

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11
Q

What section is this?

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

A

Section 7

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12
Q

True or False

The following is under section 8: This Act shall take effect upon its approval.

A

True

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13
Q

Implementing Guidelines (Old & Amended)

Administrative Order No. 201, Series of ____

A

series of 1973

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14
Q

Implementing Guidelines (Old & Amended)

Administrative Order No. ____, Series of 1976

A

No. 290

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15
Q

Implementing Guidelines (Old & Amended)

Administrative Order No. 52, Series of _____

A

series of 1983

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16
Q

Implementing Guidelines (Old & Amended)

Administrative Order No. 49-B, Series of _____

A

series of 1988

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17
Q

Implementing Guidelines (Old & Amended)

Executive Order No. ____, Series of ____

Redirecting the Functions & Operations of DOH

A

Executive Order No. 102, Series of 1999

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18
Q

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

A

Administrative Order No. 59, Series of 2001

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19
Q

Other implementing Guidelines

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

A

Administrative Order No. 2007-0027

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20
Q

Other implementing Guidelines

Amendment to Administrative Order No. 2007-0027

A

Administrative Order No. 2007-0027-A

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21
Q

Other implementing Guidelines

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

A

Administrative Order No. 2008-0002

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22
Q

Other implementing Guidelines

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

A

Administrative Order No. 2008-0007

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23
Q

At present

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

A

Administrative order No. 2021-0037

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24
Q

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

A

Health Facilities & Services Regulatory Bureau (HFSRB)

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25
Q

True or False

Health Facilities & Services Regulatory Bureau (HFSRB) was formerly known as Bureau of Health Facilities & Services (BHFS)

A

True

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26
Q

True or False

At present, the Health Facilities and Service Regulatory Bureau (HFSRB) is in charge of all clinical laboratory licensing and related concerns.

A

True

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27
Q

Who signed the A.O. 2021-0037?

A

(then) DOH Sec. Francisco Duque, III

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28
Q

Natural or juridical person who intends to operate a clinical laboratory

A

Applicant

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29
Q

HFSRB is known as

A

Health Facilities and Services Regulatory Bureau

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30
Q

CHD is known as

A

Center for Health Development

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31
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

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32
Q

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

A

Critical Values

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33
Q

Program where participating laboratories are given unknown samples for analysis

A

External Quality Assessment Program (EQAP)

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34
Q

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

A

Assessment Tool

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35
Q

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

A

Institution

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36
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

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37
Q

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

A

Licensee

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38
Q

Also refers to the license

A

License to Operate (LTO)

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39
Q

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

A

Mobile Clinical Laboratory

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40
Q

True or False

A mobile clinical laboratory must have a base laboratory in order to be allowed to operate

A

True

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41
Q

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

A

Monitoring Examinations

42
Q

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

A

National Reference Laboratory (NRL)

43
Q

NRL for Hematology, Immunohematology, Urinalysis

A

National Kidney and Transplant Institute (NKTI)

44
Q

NRL for Serology

A

STD/AIDS Central Cooperative Laboratory (SACCL)

45
Q

NRL for Clinical Chemistry

A

Lung Center of the Philippines (LCP)

46
Q

NRL for Drug Testing, Water Microbiology, Micronutrient Assay

A

East Avenue Medical Center (EAMC)

47
Q

NRL for Microbiology and Parasitology

A

Research Institute of Tropical Medicine (RITM)

48
Q

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

A

Physician’s Office Laboratory (POL)

49
Q

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

A

POCT – Point of Care Testing

50
Q

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

A

Routine Tests

51
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

52
Q

Done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure. STAT is an abbreviation for sta’tim which means immediately.

A

STAT Tests

53
Q

Classification of Laboratories (by Ownership)

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 (owned laboratory)

54
Q

Classification of Laboratories (by Ownership)

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

A

Private

55
Q

Classification of Laboratories (by Function)

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

56
Q

Classification of Laboratories (by Function)

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

A

Anatomic Pathology

57
Q

Classification of Laboratories (by Institutional Character)

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

58
Q

Classification of Laboratories (by Institutional Character)

A laboratory that does not form part of any other institution

A

Free-Standing

59
Q

Classification of Laboratories (by Service Capability)

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

A

Special Clinical Laboratory

60
Q

Classification of Laboratories (by Service Capability)

What are the four types of clinical laboratory

A
  • Primary
  • Secondary
  • Tertiary
  • Limited Service Capability (institution based)
61
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

62
Q

What type of laboratory has these service?

  • Routine Hematology
  • Complete Blood Count
  • Hemoglobin
  • Hematocrit
  • WBCCount
  • WBCDifferentialCount
  • Qualitative Platelet Determination * Routine Urinalysis
  • Routine Fecalysis
  • Blood Typing – for hospital based
A

Primary Laboratory

63
Q

What type of laboratory has these service?

  • Routine Clinical Chemistry
  • Glucose
  • Blood Urea Nitrogen
  • Uric Acid
  • Creatinine
  • Total Cholesterol
  • Quantitative Platelet Determination
  • Cross Matching – for hospital based
  • Gram Staining – for hospital based
  • KOH – for hospital based
A

Secondary Laboratory

this also includes Primary Laboratory Services

64
Q

What type of laboratory has these service?

  • Special Chemistry
  • Special Hematology, including coagulation procedures
  • Immunology
  • Microbiology - Culture and Sensitivity:
  • aerobic and anaerobic (for hospital based)
  • aerobic or anaerobic (for non-hospital based)
A

Tertiary Laboratory

this also includes Secondary Laboratory Services

65
Q

Clinical laboratories exclusive for research and teaching purposes shall be ____ from the licensing requirement but shall be required to register

A

exempted

66
Q

Special Laboratories such as:
- Assisted Reproduction Technology
- Molecular & Cellular Technology
- Molecular Biology
- Molecular Pathology
- Forensic Pathology
- Anatomic Pathology (independent from a clinical laboratory)

are also required to ____________

A

to register but not licensed

67
Q

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

A
  • Issue official laboratory results
  • Perform more than monitoring examinations
  • Cater not only to the physician’s own patients
68
Q

Who is the head of the laboratory and shall have administrative and technical supervision of the activities in the laboratory?

A

Pathologist

69
Q

What are the two kinds of Pathologist?

A
  • Clinical Pathologist
  • Anatomic Pathologist

certified by Philippine Board of Pathology

70
Q

Human Resources | True or False

Shall have staff development and CPE at all levels of the organization

A

True

71
Q

What type of laboratory can provide services for Microscopy?

Primary, Secondary, or Tertiary?

A

Primary, Secondary, & Tertiary

71
Q

What type of laboratory can provide services for Hematology?

Primary, Secondary, or Tertiary?

A

Primary, Secondary, & Tertiary

72
Q

What type of laboratory can provide services for Clinical Chemistry?

Primary, Secondary, or Tertiary?

A

Secondary & Tertiary

72
Q

What type of laboratory can provide services for Immunology?

Primary, Secondary, or Tertiary?

A

Tertiary

73
Q

What type of laboratory can provide services for Microbiology?

Primary, Secondary, or Tertiary?

A

Tertiary

74
Q

What type of laboratory can provide services for Histopathology?

A

Tertiary

Optional for primary and secondary, except in Level III Hospital

75
Q

For tertiary laboratories, what are the only 3 sections that function during PM and night shifts?

A

Microscopy, Hematology, & Clinical Chemistry

76
Q

What are the minimum and maximum woking hours of laboratory staff?

A

min: 8 hrs
max: 12 hrs

77
Q

Manual Testing: ____ /RMT/8hrs

A

50 tests

78
Q

Manual Testing: ____ /RMT/12hrs

A

75 tests

79
Q

Automated Testing: ____ /RMT/8hrs

A

100 tests

80
Q

Automated Testing: ____ /RMT/12hrs

A

150 tests

81
Q

Physical Facilities

Primary: ____ sq m
Secondary: ____ sq m
Tertiary: ____ sq m

Minimum Technical Working Area (DM No. 148 s. 2007)

A

Primary: 10 sq m
Secondary: 20 sq m
Tertiary: 60 sq m

It must be well-ventilated, adequately lighted, clean and safe

82
Q

Refusal to participate in EQAS-NRL is a basis for suspension/revocation of license

A

True

All laboratory shall participate in an EQAS given by designated NRL

83
Q

What are the two types of Quality Control?

A
  • Internal QC
  • External QC (third party institution)
84
Q

In reporting, the name and signature of the ____ & ____ must be included

A

Pathologist & RMT

No report orally or in writing without directive from pathologist or associate except in emergency cases

85
Q

In recording, files patients are kept for at least ____ year

A

1 year

86
Q

What files are kept permanently or indefinitely?

A

Anatomic and Forensic Pathology reports

87
Q

Hospitals are under what kind of Licensure system?

A

One-Stop-Shop Licensure System

88
Q

What is the period for renewal of LTO for non-hospital based facilities?

discount on renewal fee if application completed during this period

A

first day of October to last day of November

89
Q

Renewal of LTO

Processed not later than ____ working days after expiration date of LTO

A

5 days

LTO automatically cancelled without notice when failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in license

90
Q

True or False

DOH-CHD shall conduct announced or surprised inspections at any reasonable time (within lab hours)

A

True

  • Licensee shall ensure accessibility of premises and facilities for inspection of CHD Director or authorized representative(s) at any reasonable time
  • Licensee shall ensure availability of all pertinent records for checking/review of CHD Director or his authorized representative(s)
91
Q

What are the practices counted as violations

at least 5

A
  • Refusal on any clinical lab to participate in EQAP
  • Issuance of a report, orally or in writing (in whole or part thereof) which is not in accordance with documented procedures
  • Permitting unauthorized persons to perform technical procedures
  • Incompetence
  • Deviations from standard test procedures
  • Lending or using the name of licensed laboratory or head or RMT to an unlicensed laboratory
  • Unauthorized use of the name and signature of Pathologist and RMT to secure LTO
  • Reporting a test result for clinical specimens even if the test was not actually done
  • Transferring results of tests done in an outside lab to the result form of the referring laboratory
  • Performing and reporting tests in a specialty or subspecialty in which the laboratory is not licensed
  • Giving and receiving any commission, bonus or kickback or rebate or engaging in any split-fee for referral to clinical laboratory licensed by DOH
92
Q

Who shall be assigned to investigate charges or complaints on a laboratory and is allowed to suspend, cancel or revoke and may seek any law enforcement agency to execute the closure of any erring lab when necessary

A

HFSRB/CHD Director or representative

93
Q

Penalties as per AO 2021-0037

Penalties for clinical laboratories in a hospital will be governed by AO No. ____, dated June 6, 2007, titled “Violations under the One-Stop Shop Licensure System (OSSOLS) for Hospitals”

A

A.O. No. 2007-0022

94
Q

For non-institution-based CL that are not under the OSSOLS, the following are the penalties and sanctions that shall be imposed:

A
  • 1 offense: Stern warning
  • 2 offense: Thirty thousand pesos (Php 30,000.00)
  • 3 offense: Fifty thousand pesos (Php 50,000.00)
  • 4 offense: Revocation of DOH-LTO

If offender is a firm or corporation, the managing head and/or owner(s) shall be liable to the penalty imposed

95
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 & Desist Order (CDO)
Php 50,000

96
Q

When does a LTO expire?

A

December 31 / Last day of the year

97
Q

The maximum distance of a Mobile Clinical Laboratory from its base clinical laboratory is _____?

A

100 km

98
Q

Free-standing laboratories are still encouraged by the DOH

A

False

MT6313 (MT LAWS) (14 decks)

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