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BSMLS2A PRELIMS > MTLAWS AND BIOETHICS (AO 201 S. 1973 and AO 290 S. 1976) > Flashcards

MTLAWS AND BIOETHICS (AO 201 S. 1973 and AO 290 S. 1976) Flashcards

1
Q

“REVISED RULES AND REGULATIONS GOVERNING THE REGISTRATION, OPERATIONS AND MAINTENANCE OF CLINICAL LABORATORIES IN THE PHILIPPINES”

A

AO 201 S 1973

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2
Q

When is the date of approval of AO 201 S 1973?

A

October 26, 1973

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3
Q

Under what section of RA 4688 is AO 201 S 1973?

A

Section 3

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4
Q

What administrative order amended AO 201 S 1973?

A

AO 290 S 1976

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5
Q

What is the total number of sections of AO 201 S. 1973?

A

24 Sections

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6
Q

What is the name of Section 1 of AO 201 S 1973?

A

Purpose and Title

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7
Q

What section (include name) is this of AO 201 S 1973?

The Rules and Regulations published and enforced pursuant to Section 3 to Republic Act 4688 approved on June 18, 1966, are hereby revised and shall be known as “REVISED RULES AND REGULATIONS GOVERNING THE REGISTRATION IN THE PHILIPPINES” and promulgated for the purpose of preventing the operation and maintenance of substandard, improperly managed, and poorly equipped clinical laboratories.

A

Section 1. Purpose and Title

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8
Q

What is the name of Section 2 of AO 201 S 1973?

A

Scope

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9
Q

What section (include name) is this of AO 201 S 1973?

The promulgation embodied herein shall apply to any person, firm or corporation, operating and maintaining clinical laboratories in which any of all of the following: body fluids, tissues, secretions, excretions and radioactivity from human beings are analyzed for the determination of the presence of pathogenic organisms, pathologic processes and/or conditions of the persons from which they are obtained, provided that government hospital laboratories doing routine or maximum laboratory examinations are exempted if their services are declared as extensions of government regional or central laboratories, and provided further that laboratories being used solely for academic training and/or for purely research activities are likewise not herein covered.

A

Section 2. Scope

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10
Q

What is the name of Section 3 of AO 201 S 1973?

A

Basic Licensure Requirements

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11
Q

In Section 3. Basic Licensure Requirements of AO 201 S 1973:

Give at least 3 things that is required in the form of requirements.

A
  1. The name, citizenship, and domicile of the head of the laboratory
  2. The place, municipality, and province where it is to be established
  3. The name of establishment
  4. The name, citizenship, and domicile of the owner
  5. Scope and nature of work to be undertaken (see SECTION 11-C)
  6. Statement that applicant has complied with all business requirements under other existing laws or ordinances that are necessary in pursuance of the activity for which a license is herein applied for
  7. A tax clearance for the preceding year
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12
Q

In Section 3. Basic Licensure Requirements of AO 201 S 1973

Who is the only person allowed to be the head of the laboratory?

A

Pathologist or licensed physician duly in laboratory medicine

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13
Q

In Section 3. Basic Licensure Requirements of AO 201 S 1973:

How many days after establishment would BRL inspect?

A

60 Days

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14
Q

In Section 3. Basic Licensure Requirements of AO 201 S 1973:

Who would do the inspection of established laboratories?

A

Inspector of BRL

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15
Q

What is the name of Section 4 of AO 201 S 1973?

A

License Fees

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16
Q

In Section 4. License Fees of AO 201 S 1973:

How much is the renewal fee?

A

50 PHP

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17
Q

In Section 4. License Fees of AO 201 S 1973:

Tuwing kailan ung renewal?

A

Last 2 months of the year

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18
Q

In Section 4. License Fees of AO 201 S 1973

How long is the grace period for renewal and how much is the fine?

A

2 months and 10 PHP

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19
Q

What are the sections that doesn’t have a name in AO 201 S 1973?

A

Section 5, 6, and 9

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20
Q

What section is this of AO 201 S 1973

No Clinical Laboratory is allowed to operate without the proper license from the Secretary of Health thru the Bureau of Research and Laboratories who are charged with the responsibility of strictly enforcing the provisions of Republic Act No. 4688 and the Rules herein promulgated.

A

Section 5

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21
Q

What section is this? of AO 201 S 1973:

No person is permitted to manage, administer, or supervise a clinical laboratory unless he is physician, licensed and duly registered with the Board of Medical Examiners of the Republic of the Philippines, qualified in laboratory medicine as stipulated in Section 7-B and duly authorized by the Secretary of Health, such authorization to be renewed annually. This authorization shall be exempt of any fees.

A

Section 6

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22
Q

What is the name of Section 7 of AO 201 S 1973?

A

Definition of Terms

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23
Q

In Section 7. Definition of Terms: of AO 201 S 1973:

The term “Clinical Laboratories” shall mean to include any or all of the following:

A

1) Clinical Pathology
2) Anatomical Pathology
3) Forensic Pathology

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24
Q

In Section 7. Definition of Terms: of AO 201 S 1973:

Give at least 3 sections included in Clinical Pathology.

A

 Clinical Chemistry
 Hematology
 Microbiology
 Clinical Microscopy
 Serology
 Immunohematology
 Blood Banking
 Radioisotope Laboratory
 Endocrine Laboratory

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25
Q

In Section 7. Definition of Terms: of AO 201 S 1973:

Give the 3 sections included in Anatomical Pathology.

A

 Surgical Pathology
 Cytology
 Post-mortem examination

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26
Q

In Section 7. Definition of Terms: of AO 201 S 1973:

What section is included in Forensic Pathology?

A

 All medico-legal examination

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27
Q

In Section 7. Definition of Terms: of AO 201 S 1973:

____ of the laboratory should be a duly licensed physician and registered with the Medical Board Examiners of the Philippines, and qualified in laboratory medicine by having been certified by the Philippine Board of Pathology, either in Anatomical Pathology, Clinical Pathology or both; provided that in some areas where there are no Pathologists, the laboratory may be supervised by a licensed physician with training in laboratory medicine as the Director of the Bureau of Research and Laboratories may consider sufficiently adequate depending on the activities performed, and that he is authorized by the Secretary of Health as head or in–charge of such laboratory.

A

“Head”, “Chief”, “Director”, “In-charge”

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28
Q

In Section 7. Definition of Terms, subsection (c) Personnel: of AO 201 S 1973:

A licensed physician and qualified in laboratory medicine a certified by the Philippine Board of Pathology either in Anatomical Pathology, Clinical Pathology or both who is under the direct supervision of the Head, Chief, Director or In–Charge of a clinical laboratory.

A

Associate Pathologist

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29
Q

In Section 7. Definition of Terms, subsection (c) Personnel: of AO 201 S 1973:

A duly licensed physician and registered with the Philippine Board of Examiners, with at least one (1) year training in laboratory medicine, and who shall be under the direct supervision of the head.

A

Pathology Assistant

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30
Q

In Section 7. Definition of Terms, subsection (c) Personnel: of AO 201 S 1973:

Must be a licensed Medical Technologist duly registered in the Board of Examiners for Medical Technology who shall be directly under supervision of a registered Pathologist, or a licensed physician authorized by the Secretary of Health as head of the laboratory in places where there are no Pathologist.

A

Medical Technologist

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31
Q

In Section 7. Definition of Terms, subsection (c) Personnel: of AO 201 S 1973:

Must have completed at least two years of college work with at least 12 units of laboratory subjects, and one year of training in an accredited laboratory; or without college work but with at least ten years training and experience in a duly approved clinical laboratory. The laboratory technicians will be under the supervision of the medical technologists and under the over– all supervision of the head of the laboratory or his associate or assistant.

A

Medical Laboratory Technician/Laboratory Technician

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32
Q

In Section 7. Definition of Terms, subsection (c) Personnel: of AO 201 S 1973:

Should be at least high school graduates and who shall assist the medical technologists or laboratory technicians but whose activities should be limited to non–technician procedures.

A

Laboratory Aides

33
Q

In Section 7. Definition of Terms: of AO 201 S 1973:

This refers to equipment, supplies and materials being used in the performance of a laboratory examination which are not the same as those specified but could serve the purpose as well.

A

Equivalents

34
Q

What is the name of Section 8 of AO 201 S 1973?

A

Interpretations

35
Q

What section (include name) is this in AO 201 S 1973:

Except as specifically authorized by the Secretary of Health in writing, no interpretation of the meaning of the regulations or its part by any officer or employee of the Office of the Secretary of Health other than a written interpretation by the Secretary of Justice will be recognized to be binding upon the Secretary of Health.

A

Section 8. Interpretations

36
Q

What section is this? of AO 201 S 1973:

Application for license shall be filed by the owner of his duly authorized representatives in a form “Petition to Establish, Operate and Maintain a Clinical Laboratory” together with the “Information Sheet” to be filled by the Physician–In–Charge, prepared for the purpose, with the Bureau of Research and Laboratories for the necessary screening and approval. Each petition shall be signed under oath on affirmation by the applicant or a person duly authorized to act for and on his behalf.

A

Section 9

37
Q

What is the name of Section 10 of AO 201 S 1973?

A

Terms and Conditions

38
Q

In Section 10. Terms and Conditions: of AO 201 S 1973:

If the head or location of the laboratory has been changed, how long until it should be reported?

A

15 days

39
Q

What is the name of Section 11 of AO 201 S 1973?

A

Requirements for a Clinical Laboratory

40
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

What are the 3 main things required?

A

1) Personnel
2) Physical Plant
3) Minimum Equipment and Apparatus

41
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

In clinical laboratories (Aside from the personnel), it is required to employ at least ___?

A

1 Registered Medical Technologists

42
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

How many clinical laboratories a pathologist can be authorized to manage and supervise and/or be an associate pathologist.

A

Not more than 4 laboratories

43
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

In localities without qualified pathologists, a licensed physician as authorized under Section 7–B may head how many laboratories?

A

Only 1 laboratory

44
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

Give at least 3 requirements for the physical plant of a clinical laboratory.

A
  1. A clinical laboratory should be situated in a place separate from any commercial or non–medical establishment or residential quarters. It should be housed in a permanent building constructed of strong materials, preferably concrete or semi –concrete, tiled or linoleum finish.
  2. The working space of the clinical laboratory of a hospital must correlate with the bed capacity and type of hospital it serves as well as the services it offers to support the needs of the medical care of the confined and out–patients of the hospital.
  3. Adequate physical provisions for the safety of the laboratory personnel must be provided for especially considering exposure to contamination to infectious materials and obnoxious gases as well as dangers due to inflammable reagents and fires or radioisotope substances.
  4. If needed, provisions must be made for sleeping quarters separate from the laboratory area.
  5. Laboratory space cannot be utilized as a bleeding area or reception rooms for a blood bank.
45
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

What section does this equipment is required?

1) Microscope with oil immersion lens and substage lamp
2) Centrifuge
3) Hemocytometer
4) Hemoglobinometer
5) Urinalysis set
6) Burner
7) Stopwatch
8) Supplied as may be required including glassware and reagents

A

Routine examination of stool, urine, blood, sputum, and other body fluids, blood grouping and matching

46
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

What section does this equipment is required?

1) Photometer or Spectrophotometer
2) Burner
3) Water bath
4) Clinical sterilizer
5) Small drying oven
6) Refrigerator
7) Interval timer
8) Balances (Analytical and Rough)
9) Supplies as may be required including glassware, reagents, and standards.

A

Chemistry

47
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

What section does this equipment is required?

1) Autoclave
2) Incubator
3) Hot air oven
4) Centrifuge
5) Microscope
6) Water bath
7) Burner
8) pH meter
9) Balances
10) Supplies as may be required including glassware

A

Bacteriologic Examinations/Bacteriology

48
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

What section does this equipment is required?

1) Water bath (37 and 56 degrees centigrade)
2) Refrigerator
3) Clinical instrument sterilizer
4) Centrifuge
5) Interval timer
6) VDRL Rotator
7) Supplies as may be required including glassware

A

Serologic Examinations/Serology

49
Q

VDRL Rotator is used for what specifically?

A

Blood test for syphilis

50
Q

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973:

What section does this equipment is required?

1) Microtome set
2) Microscope
3) Paraffin oven
4) Staining dishes
5) Water bath
6) Interval timer
7) Supplies including glassware, reagents, and stains as may be required

A

Pathological Examinations/Histopathology

51
Q

What is the name of Section 12 of AO 201 S 1973?

A

Reporting

52
Q

In Section 12. Reporting: of AO 201 S 1973:

All laboratory requests shall be considered as ___ between the requesting physician and the pathologist of the laboratory.

As such all-laboratory reports on various examinations of human specimens shall be construed as ____.

No person working in an approved clinical laboratory shall issue a report, orally or in writing or portions thereof without the actual signature of the Pathologist of his authorized associate or assistants, to the requesting physician or his authorized representative except in emergencies when the results may be released as authorized by the Pathologist.

A

Consultation (Both answers)

53
Q

What is the name of Section 13 of AO 201 S 1973?

A

Recording

54
Q

In Section 13. Recording: of AO 201 S 1973:

How long does the clinical laboratory need to keep all reports and requests?

A

At least 1 year

55
Q

In Section 13. Recording: of AO 201 S 1973:

How long does the clinical laboratory need to keep records of anatomic and forensic pathology?

A

Permanently

56
Q

What is the name of Section 14 of AO 201 S 1973?

A

Laboratory Fees

57
Q

In Section 14. Laboratory Fees: of AO 201 S 1973:

What is not included in the laboratory fee?

A

Professional Services

58
Q

What is the name of Section 15 of AO 201 S 1973

A

Publicity

59
Q

What section (include name) is this? of AO 201 S 1973:

Publicity of the approved laboratory should be within the normal, ethical, and professional concepts of acceptable medical practice.

Only the name of the laboratory, address, telephone number of the laboratory, pathologists and assistants and field of work covered by the licensure shall appear on the letterhead and other information media.

Advertising matters should be directed exclusively to physicians through recognized professional bulletins or medical journals.

No laboratory shall make advertisement on medical pad, fictitious and unproven claim misleading statements and to advocate directly or by any means of subterfuge unreliable and inconclusive laboratory procedures which may prove detriment to patient care.

A

Section 15. Publicity

60
Q

What is the name of Section 16 of AO 201 S 1973?

A

Exhibition of Certificate of Approval and License and Rules and Regulations

61
Q

In Section 16. Exhibition of Certificate of Approval and License and Rules and Regulations: of AO 201 S 1973:

The license of the clinical laboratory should be placed where?

A

Conspicuous place within the laboratory

62
Q

What is the name of Section 17 of AO 201 S 1973?

A

Expiration

63
Q

In Section 17. Expiration: of AO 201 S 1973:

Tuwing kailan mag eexpire ang license?

A

Last day of December of the year (December 31)

64
Q

What is the name of Section 18 of AO 201 S 1973?

A

Renewal

65
Q

In Section 18. Renewal: of AO 201 S 1973:

Who is responsible for the processing and application of renewal immediately upon receipt?

A

Bureau of Research and Laboratories

66
Q

What is the name of Section 19 of AO 201 S 1973?

A

Inspection

67
Q

In Section 19. Inspection: of AO 201 S 1973:

What does this section contain?

A
  1. Each license shall give the Secretary of Health or his duly authorized representatives the opportunity at all reasonable times to inspect the premises and facilities of the clinical laboratory.
  2. Each license shall make available all records kept him pursuant to those regulations for inspection by the Secretary of Health of his authorized representatives.
  3. Directors of Regional Health Office, Provincial, city or municipal Health Officers are required to report the existence of unlicensed clinical laboratories, and/or violations of these rules to the Bureau of Research and Laboratories.
68
Q

What is the name of Section 20 of AO 201 S 1973?

A

Quality Control Test

69
Q

In Section 20. Quality Control Test: of AO 201 S 1973:

Who would conduct the quality control tests?

A

Director of the Bureau of Research and Laboratories or his representative

70
Q

In Section 20. Quality Control Test: of AO 201 S 1973:

What would happen if the results of the sample does not match the results of the standard sample?

A

The clinical laboratory will be given 3 days to fix/calibrate their machines, the next quality test SHOULD match the standard values, if not, the laboratory will be shut down.

71
Q

What is the name of Section 21 of AO 201 S 1973?

A

Modification or Revocation of License

72
Q

What is the name of Section 22 of AO 201 S 1973?

A

Investigations of Charges of Complaints

73
Q

What is the name of Section 23 of AO 201 S 1973?

A

Violations

74
Q

What is the name of Section 24 of AO 201 S 1973?

A

Effectivity

75
Q

“AMENDING SECTION 11 SUBSECTION A OF ADMINISTRATIVE ORDER NO. 201 S. 1973 CONCERNING REQUIREMENTS FOR A CLINICAL LABORATORY”

A

AO 290 S 1976

76
Q

When was the approval of AO 290 S 1976?

A

August 5, 1976

77
Q

What section and subparagraph did AO 290 S 1976 amended?

A

Section 11, subparagraph A (It is a more detailed version)

78
Q

How many sections does AO 290 S 1976 have?

A

2 sections

BSMLS2A PRELIMS (8 decks)

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