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

Question 1

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

Answer 1

AO 201 S 1973

Question 2

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

Answer 2

October 26, 1973

Question 3

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

Answer 3

Section 3

Question 4

What administrative order amended AO 201 S 1973?

Answer 4

AO 290 S 1976

Question 5

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

Answer 5

24 Sections

Question 6

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

Answer 6

Purpose and Title

Question 7

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.

Answer 7

Section 1. Purpose and Title

Question 8

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

Answer 8

Scope

Question 9

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.

Answer 9

Section 2. Scope

Question 10

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

Answer 10

Basic Licensure Requirements

Question 11

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

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

Answer 11

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

Question 12

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

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

Answer 12

Pathologist or licensed physician duly in laboratory medicine

Question 13

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

How many days after establishment would BRL inspect?

Answer 13

60 Days

Question 14

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

Who would do the inspection of established laboratories?

Answer 14

Inspector of BRL

Question 15

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

Answer 15

License Fees

Question 16

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

How much is the renewal fee?

Answer 16

50 PHP

Question 17

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

Tuwing kailan ung renewal?

Answer 17

Last 2 months of the year

Question 18

In Section 4. License Fees of AO 201 S 1973

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

Answer 18

2 months and 10 PHP

Question 19

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

Answer 19

Section 5, 6, and 9

Question 20

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.

Answer 20

Section 5

Question 21

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.

Answer 21

Section 6

Question 22

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

Answer 22

Definition of Terms

Question 23

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:

Answer 23

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

Question 24

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

Give at least 3 sections included in Clinical Pathology.

Answer 24

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

Question 25

In Section 7. Definition of Terms: of AO 201 S 1973: Give the 3 sections included in Anatomical Pathology.

Answer 25

 Surgical Pathology  Cytology  Post-mortem examination

Question 26

In Section 7. Definition of Terms: of AO 201 S 1973: What section is included in Forensic Pathology?

Answer 26

 All medico-legal examination

Question 27

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.

Answer 27

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

Question 28

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.

Answer 28

Associate Pathologist

Question 29

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.

Answer 29

Pathology Assistant

Question 30

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.

Answer 30

Medical Technologist

Question 31

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.

Answer 31

Medical Laboratory Technician/Laboratory Technician

Question 32

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.

Answer 32

Laboratory Aides

Question 33

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.

Answer 33

Equivalents

Question 34

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

Answer 34

Interpretations

Question 35

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.

Answer 35

Section 8. Interpretations

Question 36

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.

Answer 36

Section 9

Question 37

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

Answer 37

Terms and Conditions

Question 38

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?

Answer 38

15 days

Question 39

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

Answer 39

Requirements for a Clinical Laboratory

Question 40

In Section 11. Requirements for a Clinical Laboratory: of AO 201 S 1973: What are the 3 main things required?

Answer 40

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

Question 41

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 ___?

Answer 41

1 Registered Medical Technologists

Question 42

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.

Answer 42

Not more than 4 laboratories

Question 43

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?

Answer 43

Only 1 laboratory

Question 44

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.

Answer 44

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.

Question 45

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

Answer 45

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

Question 46

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.

Answer 46

Chemistry

Question 47

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

Answer 47

Bacteriologic Examinations/Bacteriology

Question 48

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

Answer 48

Serologic Examinations/Serology

Question 49

VDRL Rotator is used for what specifically?

Answer 49

Blood test for syphilis

Question 50

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

Answer 50

Pathological Examinations/Histopathology

Question 51

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

Answer 51

Reporting

Question 52

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.

Answer 52

Consultation (Both answers)

Question 53

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

Answer 53

Recording

Question 54

In Section 13. Recording: of AO 201 S 1973: How long does the clinical laboratory need to keep all reports and requests?

Answer 54

At least 1 year

Question 55

In Section 13. Recording: of AO 201 S 1973: How long does the clinical laboratory need to keep records of anatomic and forensic pathology?

Answer 55

Permanently

Question 56

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

Answer 56

Laboratory Fees

Question 57

In Section 14. Laboratory Fees: of AO 201 S 1973: What is not included in the laboratory fee?

Answer 57

Professional Services

Question 58

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

Answer 58

Publicity

Question 59

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.

Answer 59

Section 15. Publicity

Question 60

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

Answer 60

Exhibition of Certificate of Approval and License and Rules and Regulations

Question 61

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?

Answer 61

Conspicuous place within the laboratory

Question 62

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

Answer 62

Expiration

Question 63

In Section 17. Expiration: of AO 201 S 1973: Tuwing kailan mag eexpire ang license?

Answer 63

Last day of December of the year (December 31)

Question 64

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

Answer 64

Renewal

Question 65

In Section 18. Renewal: of AO 201 S 1973: Who is responsible for the processing and application of renewal immediately upon receipt?

Answer 65

Bureau of Research and Laboratories

Question 66

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

Answer 66

Inspection

Question 67

In Section 19. Inspection: of AO 201 S 1973: What does this section contain?

Answer 67

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.

Question 68

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

Answer 68

Quality Control Test

Question 69

In Section 20. Quality Control Test: of AO 201 S 1973: Who would conduct the quality control tests?

Answer 69

Director of the Bureau of Research and Laboratories or his representative

Question 70

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?

Answer 70

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.

Question 71

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

Answer 71

Modification or Revocation of License

Question 72

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

Answer 72

Investigations of Charges of Complaints

Question 73

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

Answer 73

Violations

Question 74

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

Answer 74

Effectivity

Question 75

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

Answer 75

AO 290 S 1976

Question 76

When was the approval of AO 290 S 1976?

Answer 76

August 5, 1976

Question 77

What section and subparagraph did AO 290 S 1976 amended?

Answer 77

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

Question 78

How many sections does AO 290 S 1976 have?

Answer 78

2 sections