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[MT 6313] MT Laws > [3] RA 4688 > Flashcards

[3] RA 4688 Flashcards

1
Q

Clinical Laboratory Law of 1966

A

RA 4688

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2
Q

RA 4688 is composed of how many sections?

A

8 sections

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3
Q

RA 4688 was approved on] ______________________

A

18-Jun-66

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4
Q

An Act regulating the operation and mainte nance of clinical labora tories and requiring the registration of the same with the Department of Health, providing penal ty for the violation there of, and for other purpos es

A

RA 4688

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5
Q

Covers regulation and operation of all clinical laboratories nationwide, which focuses on for malizing the operations of clinical laboratories nationwide

A

RA 4688

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6
Q

Any person, form 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 __________________ at the office of the Secretary of Health

A

Annually

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7
Q

Exemption for the annual securing of license for clinical labs

A

Government hospital laboratories doing routine or minimum laboratory examinations (e.g. gov ernment satellite laboratories)

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8
Q

T/F 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 un der the administration, direction, and supervision of an authorized physician.

A

TRUE

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9
Q

T/F It shall be unlawful for any person to be pro fessionally in charge of a registered clinical lab oratory unless he is a licensed physician duly qualified in laboratory medicine and autho rized by the Secretary of Health, such authorization to

A

TRUE

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10
Q

The ____________________________, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of RA 4688t and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.

A

Secretary of Health

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11
Q

In the 1960s, they were in charge of inspecting the operations of clinical laboratories

A

Bureau of Research and Laboratories (BRL)

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12
Q

In the present time, they are the ones in charge of inspecting the opera tions of clinical laborato ries

A

Health Facilities and Services Regulatory Bureau (HFSRB)

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13
Q

Imprisonment for not less than one month but not more than one year. A fine of not less than one thousand pesos nor more than five thousand pesos. Or both such fine and imprisonment

A

Repercussions of violating RA 4688

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14
Q

Any violation of the provisions of the act shall be punished with Imprisonment: Fine:

A

Imprisonment: not less than one month but not more than one year Fine: not less than one thousand pesos but not more than five thousand pesos

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15
Q

T/F Section 5 of RA 4688 is the separability clause of the law

A

TRUE

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16
Q

The budget appropriation of the enforcement of RA 4688 is ______________________

A

50,000 pesos

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17
Q

T/F Section 7 of RA 4688 is the repealing clause of the law

A

TRUE

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18
Q

Directive necessary to administer properly current affairs but not consistent with the constitu tion or the court, which revised rules and reg ulations governing the registration operations and maintenance of clinical laboratories

A

Administrative Order No. 201, Series of 1973

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19
Q

Discussed the work force requirement of clinical laboratory

A

Administrative Order No. 290, Series of 1976

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20
Q

Reengineered the services of Department of Health followed by the devolution of services rendered by the DOH to the local government unit

A

Executive Order No. 102, Series of 1999

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21
Q

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

A

Administrative Order No. 2001-0059

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22
Q

Prescribed minimum standard of clinical lab oratory to ensure accuracy and precision in lab examination- AO No. 2007-0027- AO No. 2008-0002- AO No. 2008-0007

A

Administrative Order No. 2007-0027

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23
Q

Exempted the National Tuberculosis Reference Laboratory (NTRL) and its regional TB refer ence laboratory per forming TB culture from securing a license to co operate a clinical labo ratory

A

Administrative Order No. 2007-0027-A

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24
Q

The cost of laboratory test should be posted publicly to standardize the pricing of lab tests to protect the consumers from overpricing- AO No. 2007-0027- aO No. 2008-002- AO 2021-0037

A

Administrative Order No. 2008-0002

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25
Q

Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Labora tories- No. 2008-0002- No. 2008-0007

A

Administrative Order No. 2008-0007

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26
Q

By 2008, the cost of registration of clinical laboratories was ______________________

A

1200 - 2500 pesos

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27
Q

Universal Health Care Act

A

RA 11223

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28
Q

In charge of all clinical laboratory licensing and related concerns

A

Health Facilities and Service Regulatory Bureau (HFSRB)

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29
Q

The Health Facilities and Service Regulatory Bureau (HFSRB) was formerly known as ______________________

A

Bureau of Health Facilities & Services (BHFS)

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30
Q

A bureau of the DOH which sets minimum standards for the regulation of health facilities and services, disseminate regulatory policy and standards, information and compliance and most importantly issues permit to construct, license to operate, and certificate of accreditation of labs

A

Health Facilities and Service Regulatory Bureau (HFSRB)

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31
Q

Administrative order No. 2021-0037 was signed by ______________________

A

DOH Secretary Franscisco Duque III

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32
Q

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

A

Administrative order No. 2021-0037

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33
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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34
Q

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

A

Critical Values

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35
Q

Program where participating laboratories are given unknown samples for analysis

A

External Quality Assessment Program (EQAP)

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36
Q

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

A

License to Operate (LTO)

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37
Q

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

A

Licensee

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38
Q

Laboratory testing unit that moves from testing site to another test ing site, or has a temporary testing location; shall have a base laboratory

A

Mobile Clinical Laboratory

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39
Q

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

A

Monitoring Examinations

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40
Q

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

A

National Reference Laboratory (NRL)

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41
Q

NRL for Hematology, Immunohematology, Urinalysis

A

National Kidney and Transplant Institute (NKTI)

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42
Q

NRL for Serology

A

STD/AIDS Central Cooperative Laboratory (SACCL)

43
Q

NRL for Clinical Chemistry

A

Lung Center of the Philippines (LCP)

44
Q

NRL for Drug Testing, Water Microbiology, Micronutrient Assay

A

East Avenue Medical Center (EAMC)

45
Q

NRL for Microbiology and Parasitology

A

Research Institute of Tropical Medicine (RITM)

46
Q

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

A

Physician’s Office Laboratory (POL)

47
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 (POCT)

48
Q

Basic, commonly requested tests in the lab oratory, the results of which are not required to be released immedi ately upon completion

A

Routine Tests

49
Q

Examples of Routine Tests

A

CBC, Urinalysis, Fecalysis

50
Q

Tests designated as STAT are to be processed immediately within ______ of the procedure

A

1 hour

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

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 Laboratories

53
Q

Owned, established and operated by any individual, corporation, association or organiza tion

A

Private Laboratories

54
Q

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

A

Clinical Pathology

55
Q

Includes Surgical Pathology, immuno histopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology

A

Anatomic Pathology

56
Q

Focus of specimens in Clinical Pathology Labs vs Anatomic Pathology Labs

A

Clinical Pathology - body fluids Anatomic Pathology - tissues

57
Q

A laboratory that operates within the premises and as part of an insti tution, 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 laboratories

58
Q

A laboratory that does not form part of any other institution

A

Free-standing laboratories

59
Q

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

A

National Reference Laboratory (NRL)

60
Q

Routine Hematology Complete Blood Count (Hemoglobin,Hemat ocrit, WBC Count, WBC Differential Count) Qualitative Platelet Determination Routine Urinalysis Routine Fecalysis Blood Typing - for hospital based

A

Service capabilities of primary laboratories

61
Q

All Primary Laboratory services plus: Routine Clinical Chemistry (Glucose, Blood Urea Nitrogen, Uric Acid, Creatinine, Total Cho lesterol) Quantitative Platelet Determination Cross Matching - For hospital based Gram Staining - for hospital based KOH - for hospital based

A

Service capabilities of secondary laboratories

62
Q

All Secondary Laboratory plus: Special Chemistry Special Hematology, including coagulation pro cedures Immunology Microbiology (Culture and Sensitivity, Aerobic and anaerobic (for hospital based and non-hospital based)

A

Service capabilities of tertiary laboratories

63
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

64
Q

Sanctions imposed on clinical laboratories not under the One Stop Shop Licensing System (OSSOLS)

A

1st offense: Stern warning 2nd offense: 30,000 pesos 3rd offense: 50,000 pesos 4th offense: revocation of DOH-LTO

65
Q

Any person who operates a CL without securing the necessary DOH-PTC and cor responding DOH-LTO shall be issued a Cease-and-Desist Or der (CDO) and shall pay the adminis trative penalty of ______________

A

50,000 pesos

66
Q

COVID laboratories that are created by law; and may be under organi zations such as DOH, LGUs, DND, PNP, DOJ, SUCs, and GOCs.

A

Government Labs

67
Q

COVID laboratories that are owned, established and operated with funds through donation, prin cipal, investment or oth er means by any individual corporation, association or organization

A

Private Labs

68
Q

COVID laboratories within the premises or compound of the hospital

A

Hospital based

69
Q

COVID laboratories located outside the premises or compound of a hospital and in dependently function ing on its own

A

Non hospital based

70
Q

Personnel for COVID 19 Labs

A

1 Pathologist 3 Analysts (3 MTs, or 2MTs and 1 Allied Health) 1 Lab Aide 1 Receptionist 1 Encoder

71
Q

Minimum respirator efficiency used for COVID 19 Labs

A

95% efficiency (N95 masks)

72
Q

Biological safety cabi net used in a COVID 19 Lab

A

Class II, Type A2 BioSafety Cabinet

73
Q

T/F Clinical laboratories exclusive for research and teaching purpos es shall be exempted from the licensing re quirement but shall be required to register

A

TRUE

74
Q

POLs are 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

75
Q

Special Laboratories that are also required to register but not licensed

A

Assisted Reproduction Technology Molecular & Cellular Technology Molecular Biology Molecular Pathology Forensic Pathology Anatomic Pathology

76
Q

Head of Laboratory

A

Pathologist

77
Q

Minimum number of medtechs in a primary lab

A

8hr shifts - 4 RMTs 12 hr shifts - 3 RMTS

78
Q

Minimum number of medtechs in a sec ondary lab

A

8hr shifts - 6 RMTs 12 hr shifts - 5 RMTS

79
Q

Minimum number of medtechs in a tertiary lab

A

8hr shifts - 14 RMTs 12 hr shifts - 11 RMTS

80
Q

Minimum working area for a primary laboratory

A

10 sqm

81
Q

Minimum working area for a secondary labora tory

A

20 sqm

82
Q

Minimum working area for a tertiary laboratory

A

60 sqm

83
Q

Done everyday to ensure reliability

A

Internal quality control

84
Q

All laboratory shall par ticipate in an Exter nal Quality Assessment Services (EQAS) given by designated NRL

A

External quality control

85
Q

T/F Oral reports or in writing without directive from pathologist or associate is permitted even with out an emergency case

A

FALSE

86
Q

Duration of recording of files in a laboratory

A

1 year; Permanent if anatomic and forensic pathology reports

87
Q

Renewal of LTO for non-hospital based labs

A

First day of October to last day of November

88
Q

Deadline of renewal of LTO

A

Not later than 5 days after expiration of LTO

89
Q

T/F LTO automatically can celed without notice when failure to submit a duly accomplished ap plication form and to pay proper fee on or be fore the expiration date stated in license

A

TRUE

90
Q

T/F Centers for Health De velopment(CHD) shall conduct announced in spections at any rea sonable time

A

TRUE

91
Q

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 docu mented procedures- Permitting unauthorized persons to perform technical procedures- ncompetence - Deviations from standard test procedures- Lending or using the name of licensed labora tory 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

A

Possible violations of any clinical lab

92
Q

They shall investigate the complaint and sus pend, cancel or revoke and may seek any law enforcement agency to execute the closure of any erring lab when necessary

A

FSRB/CHD Director or representative

93
Q

New rules and regulations for governing of clinical laboratories- AO No. 2007-0027- AO No. 2008-0002- AO 2021-0037

A

AO 2021-0037

94
Q

Guidelines in securing a license to operate COVID 19 Testing Laboratory

A

AO No. 2020-0014

95
Q

Amendment to AO 2020-0014

A

AO 2020-0014-A

96
Q

Amendment to AO 2020-0014-1

A

AO 2020-0014-B

97
Q

Minimum personnel of COVID19 Lab

A

7

98
Q

Commonly gives biosafety and biosecurity training

A

BioRisk Association of the Philippines

99
Q

Temperature of freezer for COVID 19 reagents

A

-20 degrees

100
Q

Temperature for refrigerator for reagents

A

4 degrees

101
Q

Commonly used micropipettes

A

0.5-10 uL

102
Q

Blue micropipette tip

A

100-1000uL

103
Q

Yellow to clear micropipette tip

A

lower than 100uL

[MT 6313] MT Laws (5 decks)

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