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PMLS > RA NO. 4688, AO NO. 59s. 2001 > Flashcards

RA NO. 4688, AO NO. 59s. 2001 Flashcards

1
Q

What does Republic Act No. 4688 regulate?

A

The operation, maintenance, and registration of clinical laboratories in the Philippines.

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2
Q

What must all clinical laboratories in the Philippines do according to Section 1 of R.A. 4688?

A

Register and secure a license annually at the office of the Secretary of Health.

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3
Q

Who can be in charge of a clinical laboratory as per Section 2?

A

A licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health.

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4
Q

What is the consequence of violating the provisions of R.A. 4688 under Section 4?

A

Punishment with imprisonment for 1 month to 1 year, or a fine of ₱1,000 to ₱5,000, or both.

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5
Q

What is the title of Administrative Order No. 59 s. 2001?

A

Rules and Regulations Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines.

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5
Q

What does Section 5 of R.A. 4688 state about the validity of the act?

A

If any part of the Act is judged invalid, the judgment does not affect the rest of the Act.

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6
Q

How much is appropriated to implement the provisions of R.A. 4688 as per Section 6?

A

₱50,000 from the National Treasury.

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7
Q

When was R.A. 4688 approved?

A

June 18, 1966.

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8
Q

What is the purpose of the rules in Administrative Order No. 59 s. 2001 as per Section 3?

A

To protect and promote health by ensuring properly managed clinical laboratories with effective performance.

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8
Q

What does Section 2 of Administrative Order No. 59 s. 2001 pertain to?

A

The authority to implement R.A. 4688, as well as E.O. 102 s. 1999.

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9
Q

What laboratories are excluded from the scope of Section 4 of A.O. No. 59 s. 2001?

A

Government laboratories limited to acid-fast bacilli microscopy, malaria screening, and cervical cancer screening.

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10
Q

What are the classifications by function in Section 5 of A.O. No. 59 s. 2001?

A

Clinical Pathology and Anatomic Pathology.

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11
Q

What are the classifications by institutional character under Section 5?

A

Hospital-based and non-hospital-based laboratories.

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12
Q

What services must a primary laboratory provide as per Section 5?

A

Routine Hematology, Urinalysis, Fecalysis, Blood Typing, and Quantitative Platelet Determination.

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13
Q

What services must a secondary laboratory provide as per Section 5?

A

Primary laboratory services and Routine Clinical Chemistry and Crossmatching.

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14
Q

What additional services must a tertiary laboratory provide as per Section 5?

A

Special Chemistry, Special Hematology, Immunology/Serology, and Microbiology.

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15
Q

What is required before constructing a clinical laboratory as per Section 6 of A.O. No. 59 s. 2001?

A

An approved permit to construct and design layout from BHFS.

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16
Q

What documents are required to apply for a permit to construct a clinical laboratory?

A

A letter of application, four sets of site development and floor plans, and DTI/SEC registration for private laboratories.

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17
Q

How often must a clinical laboratory’s license be renewed as per Section 7?

A

Every year

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18
Q

What is the penalty for late renewal of a clinical laboratory license?

A

₱1,000 if filed within 2 months after expiration, with an additional ₱100 per month beyond that.

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19
Q

How often must clinical laboratories be inspected according to Section 6?

A

Every 2 years or as necessary.

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20
Q

What happens to clinical laboratories that refuse to be inspected as per Section 8?

A

Their licenses may be suspended or revoked.

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21
Q

What must a clinical laboratory make available for inspection?

A

Premises, facilities, and records of laboratory examinations.

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22
Q

Who is responsible for reporting unlicensed clinical laboratories?

A

Provincial, City, and Municipal Health Officers.

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23
Q

What is required in laboratory reports under Section 7 of A.O. No. 59 s. 2001?

A

The name and signature of the registered medical technologist and the Pathologist.

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24
Q

What must be included in a clinical laboratory’s internal quality control program?

A

Competency assessment for personnel, standard laboratory methods, equipment maintenance, and quality control reference materials.

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25
Q

What is the purpose of the External Quality Control Program under Section 6?

A

Participation in a National Reference Laboratory’s program is necessary for license renewal.

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26
Q

How long should clinical laboratory records be kept as per Section 8?

A

For at least 1 year; anatomic and forensic pathology records must be kept permanently.

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27
Q

What must clinical laboratories comply with regarding waste management?

A

Adequate and efficient disposal of waste per DOH guidelines.

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28
Q

How must laboratory fees be determined according to Section 9?

A

Based on prevailing rates and quality control of laboratory procedures.

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29
Q

What must a clinical laboratory do before transferring to a new location?

A

Notify the CHD at least 15 days before transfer and comply with licensing requirements for the new location.

30
Q

What are the conditions for modifying or revoking a laboratory’s license as per Section 10?

A

Violations of the terms, material false statements, or public health interests.

31
Q

What must be reported if a clinical laboratory changes ownership or location?

A

The changes must be reported to BHFS/CHD within 15 days.

32
Q

What is the penalty for operating a clinical laboratory without a proper license?

A

Imprisonment for 1 to 12 months, or a fine of ₱1,000 to ₱5,000, or both.

33
Q

How long must a clinical laboratory file reports?

A

At least 1 year for general records; permanently for anatomic and forensic pathology.

34
Q

How must laboratory results be released?

A

Only with the directive of the Pathologist, except in emergencies.

35
Q

What constitutes a violation under Section 8 of A.O. No. 59 s. 2001?

A

Operating without a certified pathologist, change of personnel or location without notification, refusal of inspection, and gross negligence.

36
Q

How often must the list of licensed clinical laboratories be published?

A

Annually, in a newspaper of general circulation.

37
Q

What should a clinical laboratory’s quality assurance program include?

A

Both internal and external quality control procedures.

38
Q

What must be included in the staffing of a clinical laboratory?

A

A licensed physician and a sufficient number of registered medical technologists.

39
Q

What must the physical facilities of a clinical laboratory include?

A

Adequate lighting, ventilation, cleanliness, and safety, with sufficient space for operations.

40
Q

How many square meters must a primary clinical laboratory have?

A

At least 10 square meters.

41
Q

What types of equipment must a clinical laboratory provide?

A

Appropriate equipment for all the activities and laboratory examinations being performed.

42
Q

What is the minimum space requirement for a secondary clinical laboratory?

A

At least 20 square meters.

43
Q

What is the minimum space requirement for a tertiary clinical laboratory?

A

At least 60 square meters.

44
Q

What is required for a laboratory to maintain its license according to Section 9 of A.O. No. 59 s. 2001?

A

Compliance with licensing requirements, and the license must be placed in a conspicuous location within the laboratory.

45
Q

What happens if a clinical laboratory changes its substantial conditions without informing BHFS/CHD?

A

The laboratory’s license may be revoked.

46
Q

What happens if a clinical laboratory refuses to participate in the External Quality Assurance Program?

A

Its license can be suspended or revoked.

47
Q

Who is authorized to inspect clinical laboratories?

A

The Director of BHFS/CHD or their duly authorized representatives.

48
Q

What must be done before opening a clinical laboratory?

A

Secure a license from BHFS/CHD and comply with all requirements including a permit to construct.

49
Q

How often should clinical laboratories participate in the External Quality Assurance Program?

A

Regularly, as a requirement for license renewal.

50
Q

What should laboratory staff undergo to ensure compliance with quality standards?

A

Continuous competency assessments and training programs.

51
Q

What must be available in a clinical laboratory in terms of supplies?

A

Adequate and appropriate glassware, reagents, and supplies for all laboratory procedures.

51
Q

What is the role of the National Reference Laboratories in clinical laboratory operations?

A

They provide External Quality Assurance Programs to assess laboratory performance.

52
Q

What constitutes “gross negligence” in the operation of a clinical laboratory?

A

Any act or omission detrimental to the public’s health and safety.

53
Q

What must be done to renew a clinical laboratory’s license?

A

Submit a notarized application form “Application for Renewal of License” within 90 days before the license expires.

54
Q

How long must anatomic and forensic pathology records be kept?

A

Permanently in the laboratory.

55
Q

What happens to a laboratory’s license if its ownership changes?

A

The change must be reported to BHFS/CHD, or the license may be revoked.

56
Q

What must a clinical laboratory do if it transfers to a new location?

A

Notify BHFS/CHD at least 15 days before the transfer and undergo a re-inspection.

57
Q

What happens if a clinical laboratory is found to have made a false statement in its license application?

A

Its license may be suspended, revoked, or modified.

58
Q

What is the penalty for clinical laboratories operating without a valid license?

A

Imprisonment for 1 to 12 months, or a fine between ₱1,000 and ₱5,000, or both.

59
Q

How often must clinical laboratory records be made available for inspection?

A

At any reasonable time, upon request from BHFS/CHD representatives.

60
Q

What actions are grounds for suspension or revocation of a clinical laboratory license?

A

Violations of R.A. 4688 or any associated rules and regulations.

61
Q

What are the qualifications for a physician managing a clinical laboratory?

A

A licensed physician certified by the Philippine Board of Pathology, or with three months’ training in laboratory medicine where pathologists are unavailable.

62
Q

What are the responsibilities of the Secretary of Health regarding clinical laboratories?

A

Enforcing the provisions of R.A. 4688 and issuing necessary rules and regulations.

63
Q

What must be included in laboratory reports?

A

The name of the registered medical technologist and the Pathologist, both duly signed.

64
Q

What happens if a clinical laboratory’s license is revoked or canceled?

A

The laboratory will be summarily closed, and law enforcement may assist in its closure.

65
Q

What happens if a clinical laboratory continues to operate after its license is revoked?

A

It may face criminal prosecution, and its closure cannot be stopped by a restraining order.

66
Q

What must be done when a laboratory report is issued in emergency cases?

A

The report can be released under the authorization of the Pathologist.

67
Q

What actions should a laboratory take for proper waste disposal?

A

Follow the Department of Health and local government guidelines for waste management.

68
Q

How long should clinical laboratory records be kept for routine procedures?

A

At least 1 year for routine laboratory records.

69
Q

What should a clinical laboratory do if an inspection identifies violations?

A

Correct the violations to avoid suspension or revocation of its license.

70
Q

What are the staffing requirements for hospital-based clinical laboratories?

A

At least one registered medical technologist per shift must be available to cover the laboratory operations.

71
Q

What constitutes a “non-hospital-based laboratory”?

A

A laboratory that operates independently of a hospital.

72
Q

What does Section 13 of Administrative Order No. 59 s. 2001 specify?

A

The rules and regulations take effect 15 days after publication in the Official Gazette or a newspaper of general circulation.

73
Q

What should be included in the site and floor plans when applying for a permit to construct a clinical laboratory?

A

The plans must be approved by an architect or engineer.

74
Q

What happens if a clinical laboratory is found guilty of the charges after investigation?

A

Its license may be suspended, canceled, or revoked, and legal actions may be taken.

PMLS (2 decks)

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