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MEDTECH LAWS > Republic Act No. 4688 > Flashcards

Republic Act No. 4688 Flashcards

1
Q

What is Republic Act No. 4688 known as?

A

Clinical Laboratory Act of 1966.

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2
Q

When was Republic Act No. 4688 approved?

A

June 18, 1966.

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3
Q

Who was originally responsible for enforcing Republic Act No. 4688?

A

The Secretary of Health, through the Bureau of Research and Laboratories (BRL).

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4
Q

What agency currently enforces the provisions of Republic Act No. 4688?

A

The Department of Health (DOH).

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5
Q

When was the Bureau of Research and Laboratories (BRL) abolished?

A

1999

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6
Q

What agency took over the regulatory functions after BRL was abolished?

A

Health Facilities and Services Regulatory Bureau (HFSRB) or Bureau of HFS.

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7
Q

What was established in 2000 for technical reference and quality assessment?

A

The National Reference Laboratory (Technical Function) and NEQAS (National External Quality Assessment Scheme).

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8
Q

What is Administrative Order No. 2021-0037?

A

New rules and regulations governing the regulation of clinical laboratories in the Philippines, aligned with RA 11223 (Universal Healthcare).

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9
Q

What is the purpose of Administrative Order No. 2021-0037?

A

To provide new guidelines for licensing diagnostic clinical laboratories.

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10
Q

What are the classifications of clinical laboratories by ownership?

A
  1. Government (national or local government), 2. Private (individual, corporation, association, or organization).
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11
Q

What are the classifications of clinical laboratories by institutional character?

A
  1. Institution-based (within a DOH-licensed health facility), 2. Non-institution-based (operates independently).
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12
Q

What are the classifications of clinical laboratories by function under AO 2021-0037?

A
  1. Clinical Pathology, 2. Anatomic Pathology, 3. Molecular Pathology.
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13
Q

What does Clinical Pathology involve?

A

Deals with the chemical and cellular analyses of blood and other body fluids.

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14
Q

What does Anatomic Pathology involve?

A

Processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues.

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15
Q

What does Molecular Pathology involve?

A

Analysis of certain genes, proteins, and other molecules.

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16
Q

How were clinical laboratories previously classified by function?

A

Clinical, Anatomic, and Molecular.

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17
Q

What law governs legislative regulations of clinical laboratories?

A

Republic Acts (RAs).

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18
Q

What governs DOH-related regulations for clinical laboratories?

A

Administrative Orders (AOs).

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19
Q

What services are offered by a primary clinical laboratory?

A

Urinalysis, Fecalysis, FOBT, Pregnancy test (LFA), Wet smear for Trichomonas, FBS/RBS, OGTT, Lipid profile, BUN, Creatinine, BUA, CBC, Blood grouping (ABO and Rh), Rapid tests (Dengue, Syphilis, Hepatitis B, HIV screening), TB (DSSM or NAAT for government facilities).

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20
Q

What is the minimum number of personnel for a primary lab?

A

8 (without microbiology); 9 (government facility).

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21
Q

What services are included in a secondary clinical laboratory?

A

Primary lab services plus Serum electrolytes, ALT, AST, Coagulation (PT/PTT), Gram stain, KOJ, Pap smear.

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22
Q

What is the minimum number of personnel for a secondary lab?

A

12

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23
Q

What services are included in a tertiary clinical laboratory?

A

Secondary lab services plus other chemistry tests, ABG, Machine-based serological tests (e.g., tumor markers, thyroid function tests, hepatitis profile), Cytology and Histopathology.

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24
Q

What is the minimum number of personnel for a tertiary lab focusing on histopathology?

A

13 (hospital-based histopathology).

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25
Q

What is a limited clinical laboratory?

A

A lab providing 1-2 specialized tests not classified under Anatomic or Molecular Pathology (e.g., hormones, tumor markers, DOH program-related tests).

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26
Q

Is there a specified number of personnel for a limited lab?

A

No.

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27
Q

What services does a clinical lab for anatomic pathology provide?

A

Cytology and Histopathology.

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28
Q

What services does a clinical lab for molecular pathology provide?

A

Genetics, Immuno/Hematopathology, and Infectious Diseases.

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29
Q

What is required for constructing or renovating a clinical laboratory?

A

A Permit to Construct (DOH-PTC).

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30
Q

What is the validity period of a License to Operate (DOH-LTO) for a clinical lab?

A

1 year.

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31
Q

What is the validity period for a Certificate of Registration (COR) for research and teaching labs?

A

3 years.

32
Q

Who regulates and licenses clinical laboratories for teaching or research purposes?

A

DOH-HFSRB (Health Facilities and Services Regulatory Bureau).

33
Q

What is the OSSLS (One Stop Shop Licensing System) validity for hospital-based labs?

A

1 year.

34
Q

What is a Mobile Clinical Laboratory (MCL)?

A

A laboratory testing unit capable of performing limited clinical diagnostic procedures within a 100 km radius (LTO validity applies).

35
Q

What is a Satellite Clinical Laboratory?

A

An extension of the main clinical laboratory located within the facility’s compound or premises, performing emergency tests.

36
Q

What is a Physician’s Office Laboratory (POL)?

A

A doctor’s office or clinic where clinical lab exams are performed for monitoring patients, without issuing official results.

37
Q

What is a National Reference Laboratory (NRL)?

A

The highest-level lab in the country performing highly complex procedures.

38
Q

What is required before clinical lab results can be given?

A

A valid License to Operate (LTO).

39
Q

What is the minimum visit requirement for the head of a free-standing clinical lab?

A

At least once a month for physical visits and twice a week for supervisory calls/videoconferencing OR at least once a week for physical visits.

40
Q

What is the visit requirement for the head of a hospital-based DOH-licensed clinical lab?

A

At least once a week for physical visits.

41
Q

What are the personnel requirements for a clinical lab?

A

Adequate number of full-time Registered Medical Technologists (RMTs), a designated Biosafety and Biosecurity Officer, and sufficient support staff (e.g., lab technicians, aides, encoders, receptionists).

42
Q

Who is responsible for biosafety and biosecurity in a clinical lab?

A

The designated Biosafety and Biosecurity Officer.

43
Q

Who are additional personnel required for a Satellite Clinical Laboratory?

A

POCT Coordinator and POCT Operator, if applicable.

44
Q

What personnel are required for a Mobile Clinical Laboratory?

A

Its own set of RMTs and support staff.

45
Q

What are the components of Quality Improvement in clinical labs?

A

Internal Quality Assurance Program and External Quality Assessment Program.

46
Q

What information must be included in laboratory reports?

A

Laboratory reports must bear the name, PRC registration number, and original signature of the registered medical technologist(s) who performed the tests and the pathologist.

47
Q

When is the use of a digital signature permitted in laboratory reports?

A

Only if it is properly authenticated by the Department of Information and Communication Technology (DICT) through the Philippine National Public Key Infrastructure (RA 8792 authentication).

48
Q

What is RA 8792 known for?

A

It governs the use of electronic signatures and authentication through the Philippine National Public Key Infrastructure.

49
Q

What are the environmental management requirements for clinical labs?

A

Details not provided; requires elaboration based on environmental protocols or standards in clinical laboratories.

50
Q

What is the purpose of Administrative Order No. 2020-0014?

A

Guidelines in securing a License to Operate a COVID-19 Testing Laboratory in the Philippines.

51
Q

What are the classifications of COVID-19 testing laboratories by ownership?

A

Government, Private.

52
Q

What are the classifications of COVID-19 testing laboratories by institutional character?

A

Hospital-based, Non-hospital-based.

53
Q

What is the minimum number of personnel required for rRT-PCR COVID-19 laboratories?

A

7 personnel: 1 board-certified Clinical Pathologist, 3 analysts (either 3 RMTs or 2 RMTs and an allied health professional), 1 laboratory aide, 1 receptionist, 1 encoder.

54
Q

What is the minimum number of personnel required for cartridge-based COVID-19 laboratories?

A

4 personnel: 1 board-certified Clinical Pathologist, 1 RMT per 8-hour shift for every 2 machines, 1 laboratory aide per 8-hour shift for every 4 machines, 1 full-time encoder per 8-hour shift for every 4 machines.

55
Q

What training and medical requirements must COVID-19 laboratory staff meet?

A

Training on fundamentals of Biosafety and Biosecurity, Molecular Diagnostics, fit testing for respirators with at least 95% efficiency, and annual medical examination including influenza vaccination.

56
Q

Which agency administers NEQAS for COVID-19 testing laboratories?

A

RITM (Research Institute for Tropical Medicine) under Microbiology and Virology.

57
Q

Who must sign and approve COVID-19 test results before release?

A

The RMT who performed the test signs the results, which are verified by a Senior RMT and approved by the Pathologist.

58
Q

What are the PCR result reporting terminologies for SARS-CoV-2?

A

Positive: SARS-CoV-2 viral RNA detected. Negative: SARS-CoV-2 viral RNA not detected.

59
Q

What is the validity of the DOH-LTO for COVID-19 testing laboratories?

A

1 year for both hospital-based and non-hospital-based laboratories.

60
Q

What is the purpose of Republic Act No. 11332?

A

Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act. COVID-19 results must be reported.

61
Q

What is the significance of Department Order 393-E s. 2000?

A

It created the National Reference Laboratories.

62
Q

What is the purpose of Department Order 820 s. 2020?

A

It institutionalizes and strengthens the National Reference Laboratories in the Philippines.

63
Q

Which laboratory handles Microbiology and Parasitology samples for HIV/AIDS, Hepatitis B and C, Syphilis, and STDs?

A

RITM (Research Institute for Tropical Medicine).

64
Q

Which laboratory handles blood donor samples for AIDS/HIV testing?

A

SLH (San Lazaro Hospital), SACCL (San Antonio Clinical and Chemical Laboratory) - Reference laboratory for STD/AIDS.

65
Q

What laboratory handles Environmental and Occupational Health, Toxicology, Micronutrient assay, Industrial and Chemical Emergencies, Drug testing?

A

RITM (Research Institute for Tropical Medicine).

66
Q

Which laboratory handles Hematology, Immunohematology, Immunopathology, Automated Urinalysis, and Anatomic Pathology for Renal Disease?

A

NKTI (National Kidney and Transplant Institute).

67
Q

Which laboratory handles Clinical Chemistry and Anatomic Pathology for Pulmonary and Pleural Diseases?

A

LCP (Laboratory of Clinical Pathology).

68
Q

Which laboratory handles Anatomic Pathology for Cardiac Diseases and Cardiac Markers?

A

PHC (Philippine Heart Center).

69
Q

What personnel are preferred for signing routine pathology tests?

A

Pathologist and Medical Technologist (MT) are preferred for signing.

70
Q

Who is responsible for signing COVID-19 test results?

A

The Senior Medical Technologist (MT) who performed the test, and the Pathologist.

71
Q

What are the roles and responsibilities of National Reference Laboratories (NRLs)?

A

NRLs provide referral services for confirmatory testing, surveillance, outbreak response, and research. They require passing NEQAS.

72
Q

What is the purpose of EQAP/NEQAS in relation to NRLs?

A

EQAP/NEQAS assesses the quality of performance and test results of clinical laboratories in collaboration with the Health Facilities and Services Regulatory Bureau.

73
Q

What training services do NRLs provide?

A

NRLs provide training to upgrade the knowledge and improve the skills of laboratory personnel.

74
Q

What is the role of NRLs in evaluating In Vitro Diagnostic Medical Devices (IVDMD)?

A

NRLs evaluate IVDMD, including reagents, in collaboration with the FDA.

75
Q

What are In Vitro Diagnostic Medical Devices (IVDMD)?

A

IVDMD includes diagnostic kits and tests.

76
Q

What role do NRLs play in surveillance systems?

A

NRLs contribute to surveillance systems that provide critical inputs to guide DOH policies and response activities of stakeholders.

77
Q

What kind of technical assistance do NRLs provide?

A

NRLs provide technical assistance to the DOH, other government agencies, the private sector, and international partners as needed.

MEDTECH LAWS (17 decks)

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