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BSMLS2A PRELIMS > MTLAWS AND BIOETHICS (AO 49-B S. 1988 and AO 2 S. 1998) > Flashcards

MTLAWS AND BIOETHICS (AO 49-B S. 1988 and AO 2 S. 1998) Flashcards

1
Q

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

A

AO 49-B S 1988

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2
Q

What administrative order amended AO 49-B S 1988?

A

AO 2 S 1998

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3
Q

What is the total number of sections of AO 49-B S 1988?

A

27 Sections

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4
Q

What is the name of Section 1 of AO 49-B S 1988?

A

Title

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5
Q

In Section 1. Title of AO 49-B S 1988?

What does it contain?

A

“Revised Rules and Regulation governing the registration, operation, and Maintenance of Clinical Laboratories in the Philippines”.

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6
Q

What is the name of Section 2 of AO 49-B S 1988?

A

Authority

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7
Q

What is the name of Section 3 of AO 49-B S 1988?

A

Purpose

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8
Q

What section (include name) is this? of AO 49-B S 1988?

These rules and regulations are promulgated to protect the health of the people by preventing the operation of sub–standard, improperly managed, and inadequately supported clinical laboratories and by improving the quality of the performance of clinical laboratory examinations.

A

Section 3. Purpose

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9
Q

What is the name of Section 4 of AO 49-B S 1988?

A

Scope

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10
Q

In Section 4. Scope: of AO 49-B S 1988?

What are following are not governed by these rules and regulations (3)?

A

a. Government laboratories doing routine or minimum laboratory examinations provided their services are declared as extensions of covered government regional or central laboratories.
b. Laboratories are being used solely for academic training and/or for purely research activities.
c. Physicians do only simple and routine examinations (routine hematology, urinalysis, fecalysis and gram staining) for their own patients only in their own clinics.

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11
Q

What is the name of Section 5 of AO 49-B S 1988?

A

Regulatory Authority

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12
Q

In Section 5. Regulatory Authority: of AO 49-B S 1988?

Who shall exercise the licensing and regulatory functions under these rules and regulations?

A

Department of Health, through the Bureau of Research and Laboratories in the Office for Standards and Regulation

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13
Q

What is the name of Section 6 of AO 49-B S 1988?

A

Classification of Laboratories

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14
Q

In Section 6. Classification of Laboratories: of AO 49-B S 1988?

What is the 3 purposes of functions?

A

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

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15
Q

In Section 6. Classification of Laboratories: of AO 49-B S 1988?

What is the 2 purposes of institutional characters?

A

1) Hospital-based laboratory
2) Free-standing laboratory

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16
Q

In Section 6. Classification of Laboratories: of AO 49-B S 1988?

What is 3 purposes of levels and services?

A

1) Primary Category
2) Secondary Category
3) Tertiary Category

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17
Q

In Section 6. Classification of Laboratories: of AO 49-B S 1988?

What category is this?

a. Routine hematology (CBC) – hemoglobin mass concentration, erythrocyte volume fraction (hematocrit), leukocyte number concentration (WBC) and leukocyte type number fraction (differential count)
b. Routine urinalysis
c. Routine fecalysis
d. Gram staining

A

Primary Category

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18
Q

In Section 6. Classification of Laboratories: of AO 49-B S 1988?

What category is this?

a. Routine hematology, urinalysis, fecalysis, and gram staining
b. Routine chemistry – blood glucose, urea, urate, creatinine, cholesterol, and total protein
c. Blood typing and cross matching

A

Secondary Category

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19
Q

In Section 6. Classification of Laboratories: of AO 49-B S 1988?

What category is this?

a. Routine hematology, urinalysis, fecalysis, and gram staining
b. Routine chemistry
c. Blood typing and cross matching, donor selection and blood selection for transfusion
d. Special chemistry
e. Special hematology
f. Culture and sensitivity for bacteria

A

Tertiary Category

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20
Q

What is the name of Section 7 of AO 49-B S 1988?

A

Licensing

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21
Q

What is the name of Section 8 of AO 49-B S 1988?

A

Licensing Requirements (Technical Standards)

22
Q

In Section 8. Licensing Requirements: of AO 49-B S 1988?

Give at least 3 requirements of the technical standards to licensing.

A

a. Proper and competent management by a physician, licensed and duly registered with the Board of Medicine (PRC), qualified in laboratory medicine, and duly authorized by the Undersecretary of Health for Standards and Regulation

b. Adequate staffing by qualified and trained personnel with at least one (1) medical technologist registered with the Board of Medical Technology (PRC)

c. Well ventilated, lighted, clean, and safe physical space sufficient to accommodate its activities

d. Necessary equipment, furniture, glassware, reagents and supplies to undertake the required services

23
Q

In Section 8. Licensing Requirements: of AO 49-B S 1988?

Who shall evaluate compliance with such technical standards in accordance with minimum requirements for such category of laboratory or additional tests applied for as may be promulgated under these rules and regulations?

A

BRL

24
Q

What is the name Section 9 of AO 49-B S 1988?

A

Management of Clinical Laboratory

25
Q

What is the name Section 10 of AO 49-B S 1988?

A

Quality Control Tests

26
Q

What is the name Section 11 of AO 49-B S 1988?

A

Reporting

27
Q

What is the name Section 12 of AO 49-B S 1988?

A

Recording

28
Q

What is the name Section 13 of AO 49-B S 1988?

A

Laboratory Rate

29
Q

What is the name of Section 14 of AO 49-B S 1988?

A

Basic License Requirements

30
Q

What is the name of Section 15 of AO 49-B S 1988?

A

Application of License

31
Q

What is the name of Section 16 of AO 49-B S 1988?

A

License Fees

32
Q

In Section 16. License Fees: of AO 49-B S 1988?

What is the fee for a primary category laboratory?

A

200 PHP

33
Q

In Section 16. License Fees: of AO 49-B S 1988?

What is the fee for a secondary category laboratory?

A

300 PHP

34
Q

In Section 16. License Fees: of AO 49-B S 1988?

What is the fee for a tertiary category laboratory?

A

500 PHP

35
Q

In Section 16. License Fees: of AO 49-B S 1988?

What is the renewal fee for a primary category laboratory?

A

100 PHP

36
Q

In Section 16. License Fees: of AO 49-B S 1988?

What is the renewal fee for a secondary category laboratory?

A

150 PHP

37
Q

In Section 16. License Fees: of AO 49-B S 1988?

What is the renewal fee for a tertiary category laboratory?

A

250 PHP

38
Q

In Section 16. License Fees: of AO 49-B S 1988?

What is the penalty fee for a late? renewal?

A

100 PHP

39
Q

What is the name of Section 18 of AO 49-B S 1988?

A

Issuance of License

40
Q

What is the name of Section 19 of AO 49-B S 1988?

A

Terms and Conditions of License

41
Q

What is the name of Section 20 of AO 49-B S 1988?

A

Exhibition of Certificate and License and Rules and Regulations

42
Q

What is the name of Section 21 of AO 49-B S 1988?

A

Expiration

43
Q

What is the name of Section 22 of AO 49-B S 1988?

A

Renewal

44
Q

What is the name of Section 23 of AO 49-B S 1988?

A

Publication of Licensed Laboratories

45
Q

What is the name of Section 24 of AO 49-B S 1988?

A

Modification and Revocation of License

46
Q

What is the name of Section 25 of AO 49-B S 1988?

A

Violations

47
Q

In Section 25. Violations: of AO 49-B S 1988?

Give at least 3 reasons for a license to be suspended or revoked.

A

a. Operation of a Clinical Laboratory without a certified Pathologist or qualified licensed physician authorized by the Undersecretary of Health or without employing a registered medical technologist or employing a person not registered as a medical technologist in such a position

b. Change of ownership, location, Head of Laboratory, or personnel without informing the Bureau of Research and Laboratories

c. Refusal to allow inspection of the laboratory by the persons authorized by the Bureau of Research and Laboratories during reasonable hours.

d. Refusal to perform tests on quality control samples required by the Bureau of Research and Laboratories

48
Q

What is the name of Section 26 of AO 49-B S 1988?

A

Investigation of Charges of Complaints

49
Q

What is the name of Section 27 of AO 49-B S 1988?

A

Effectivity

50
Q

When is the approval of AO 49-B S 1988?

A

October 24, 1988

51
Q

When is the approval of AO 2 S 1998?

A

January 22, 1998

52
Q

What are the sections that AO 2 S 1998 amended?

A

Sections 16, 21, and 22

BSMLS2A PRELIMS (8 decks)

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