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[MT 6313] MTLaws > RA 4688 > Flashcards

RA 4688 Flashcards

1
Q

Implementing Guidelines (Old & Amended)

A

● Administrative Order No. 201, Series of 1973
● Administrative Order No. 290, Series of 1976
● Administrative Order No. 52, Series of 1983
● Administrative Order No. 49-B, Series of 1988
● Executive Order No. 102, Series of 1999
● Administrative Order No. 59, Series of 2001

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2
Q

Redirecting the Functions & Operations of DOH

A

Executive Order No. 102, Series of 1999

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3
Q

Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines

A

Administrative Order No. 59, Series of 2001

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4
Q

Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

A

Administrative Order No. 2007-0027

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5
Q

Amendment to Administrative
Order No. 2007-0027

A

Administrative Order No. 2007-0027-A

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6
Q

Posting of Schedule of Fees for Laboratory and Other Diagnostic Services of Hospitals and other Health Facilities

A

Administrative Order No. 2008-0002

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7
Q

Specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories

A

Health Facilities & Services Regulatory Bureau

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7
Q

Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories

A

Administrative Order No. 2008-0007

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8
Q

is in charge all clinical laboratory
licensing and related concerns

A

Health Facilities & Services Regulatory Bureau

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8
Q

Formerly BHFS (Bureau of Health Facilities & Services)

A

Health Facilities & Services Regulatory Bureau

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9
Q

Signed by then DOH Secretary Francisco Duque

A

AO 2021-0037

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10
Q

The necessity to review the current AO and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned with the main objective of Republic Act No. 11223 or the Universal Health Care Act which is to guarantee access to quality and affordable
health products, devices, facilities and services

A

New Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines / AO 2021-0037

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11
Q

Natural or juridical person who intends to operate a clinical laboratory

A

Applicant

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12
Q

HFSRB

A

Health Facilities & Services Regulatory Bureau

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12
Q

CHD

A

Center for Health Development

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12
Q

Facility where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis and treatment of diseases

A

Clinical Laboratory

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12
Q

Panic values originally describe by Lunderberg as “life-threatening” unless something is done promptly and for which some corrective action could be undertaken

A

Critical Values

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13
Q

DOH

A

Department of Health

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14
Q

EQAP

A

External Quality Assessment Program

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15
Q

Program where participating laboratories are given unknown samples for analysis

A

External Quality Assessment Program

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16
Q

Checklist used by regulatory officers during inspection
visits to evaluate compliance of clinical laboratory to
minimum standards and technical requirements

A

Assessment Tool

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17
Q

Assessment Tool for Licensing a General Clinical Laboratory

A

AO 2021-0037 Annex B1

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18
Q

Equipment / Instruments / Glassware / Supplies / Reagents per Area of Activity / Service
Capability of General Clinical Laboratory

A

AO 2021-0037 Annex B2

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19
Q

Prohibited Acts in the Operations of Clinical Laboratories

A

AO 2021-0037 Annex C

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19
Q

Planning and Design Guidelines for General Clinical Laboratory

A

AO 2021-0037 Annex D2

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20
Q

Checklist for Review of Floor Plans General Clinical Laboratory

A

AO 2021-0037 Annex D2

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21
Q

Guidelines in Securing for Remote Collection Permit for Clinical Laboratories

A

AO 2021-0037 Annex E

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21
Q

Application Form for Certificate Of Registration for Research and Teaching Clinical Laboratory

A

AO 2021-0037 Annex F

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22
Q

Corporate body or establishment organized for an educational, medical, charitable or similar purpose

A

Institution

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23
Q

Issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the requirements set forth

A

License

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24
Q

Also refers to the license

A

License to Operate (LTO)

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24
Q

Individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance

A

Licensee

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25
Q

Laboratory testing unit that moves from testing site to
another testing site, or has a temporary testing location

A

Mobile Testing Laboratory

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26
Q

Tests done in series on patients as a guide for treatment or follow-up of their condition

A

Monitoring Examinations

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26
Q

Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas

A

National Reference Laboratory

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26
Q

NRL for Clinical Chemistry

A

Lung Center of the Philippines (LCP)

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26
Q

NRL for Hematology, Immunohematology, Urinalysis

A

National Kidney and Transplant Institute (NKTI)

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26
Q

NRL for Drug Testing, Water Microbiology, Micronutrient Assay

A

East Avenue Medical Center (EAMC)

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26
Q

NRL for Serology

A

STD / AIDS Central Cooperative Laboratory (SACCL)

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27
Q

NRL for Microbiology and
Parasitology

A

Research Institute of Tropical Medicine (RITM)

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28
Q

Individual doctor’s office / clinic wherein laboratory
examinations are performed

A

Physician’s Office Laboratory / POL

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28
Q

Diagnostic testing at or near the site of patient care rather than in clinical laboratory

Includes bedside testing, outpatient and home care

A

Point of Care Testing (POCT)

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28
Q

Basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately after completion

A

Routine Tests

28
Q

Any testing site that performs laboratory examinations
under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory

A

Satellite Testing Site

29
Q

Done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure

A

STAT Tests

30
Q

STAT is an abbreviation for ______ which means immediately

A

sta’tim

30
Q

Classification of Laboratories

Operated and maintained, partially or wholly, by the
national government, a local government unit (provincial, city, or municipal), any other political unit or any department, division, board, or agency thereof

A

Government

31
Q

Classification of Laboratories

Owned, established and operated by any individual, cooperation, association or organization

A

Private

32
Q

T/F: Private and Government clinical laboratories have different functions in the clinical lab.

A

F; they have the same function

33
Q

Clinical Pathology includes

A
  1. Clinical Chem
  2. Hematology
  3. Immunohema
  4. Microbio
  5. Immunology
  6. Clin Microscopy
  7. Endocrinology
  8. Mol Bio
  9. Cytogenetics
  10. Toxicology & Therapeutic Drug Monitoring
  11. Oth. similar disciplines
33
Q

A laboratory that does not form part of any other institution

A

Free-Standing

34
Q

Anatomic Pathology includes

A
  1. Surgical Pathology
  2. Immunohistopathology
  3. Cytology
  4. Autopsy
  5. Forensic Pathology
  6. Molecular Pathology

SICAFM

34
Q

A laboratory that operates within premises and as part of an institution, such a but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatry facility, drug rehabilitation center

A

Institution-based

35
Q

Specific services only

A

Limited Service Capability (institution based)

36
Q

A laboratory that offers highly specialized laboratory
services that are usually not provided by a general
clinical laboratory

A

Special Clinical Laboratory

37
Q

Primary Lab service capabilities

A

Routine Hema (CBC - Hemog, Hemato, WBC count, WBC diff count)
Qualitative Platelet Determination
Routine Urina
Routine Feca
Blood Typing (hosp-based)

38
Q

Secondary service capabilities

A

+ primary

Routine Clin Chem (Glucose, Blood Urea Nitro, Uric Acid, Creatinine, Total Cholesterol)
Quanti Platelet Determination
Cross Matching (hosp)
Gram Staining (hosp)
KOH (hosp)

39
Q

What labs are exempted from the licensing requirement but shall register?

A
  1. Clinical laboratories exclusive for research and teaching purposes
  2. Special Laboratories
40
Q

Provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics

A

Limited Service Capability Lavoratory

40
Q

Tertiary service capabilities

A

+ secondary

Special Chem
Special Hema
Immunology
Microbiology (Culture Sensi - Aero & Anaero [hosp] Aero/Anaero [non-hosp])

41
Q

Special labs exempted

A

○ Assisted Reproduction Technology
○ Molecular & Cellular Technology
○ Molecular Biology
○ Molecular Pathology
○ Forensic Pathology
○ Anatomic Pathology (independent from a
clinical laboratory)

42
Q

(are) required to secure a LTO when it undertakes any or all of the following activities:
○ Issue official laboratory results
○ Perform more than monitoring examinations
○ Cater not only to the physician’s own patients

A

POL / Physician’s Office Laboratory

43
Q

(in hospital) required under management of clinical laboratory

A

POCT

44
Q

Shall have administrative and technical supervision of the activities in the laboratory

A

Pathologist (Head)

44
Q

Clinical / Anatomic is certified by

A

Philippine Board of Pathology

45
Q

New Requirement for Staffing from AO 2021-0037

A

8 RMTs in the primary lab

46
Q

Minimum Technical Working Area (DM No. 148 s. 2003)

Primary

A

10 sqm

47
Q

Minimum Technical Working Area (DM No. 148 s. 2003)

Secondary

A

20 sqm

47
Q

Minimum Technical Working Area (DM No. 148 s. 2003)

Tertiary

A

60 sqm

48
Q

Well-ventilated, adequately lighted, clean and safe

A

Physical Facilities

49
Q

T/F: In External QC, all laboratory shall participate in EQAS given by designated NRL

A

T

50
Q

Basis for suspension / revocation of license

A

EQAS-NRL

51
Q

In reporting, bear the name ad signature of?

A

Pathologist & RMT

51
Q

T/F: When reporting, there should be no report orally or in writing without directive from pathologist or associate except in emergency cases

A

T

51
Q

Records are kept in a file for at least?

A

1 year

52
Q

T/F: Anatomic & clinical pathology reports are kept permanently.

A

F; anato & forensic

52
Q

Under One-Stop-Shop Licensure System for Hospitals

A

Renewal of LTO

52
Q

Renewal of LTO date for non-hospital based

A

First day of October to last day of November

53
Q

Renewal of LTO is processed not later than _____________ after
expiration date of LTO

A

5 working days

54
Q

shall conduct announced inspections at any reasonable time

A

CHD

55
Q

shall ensure accessibility of premises and facilities for inspection of CHD Director or authorized representative(s) at any reasonable time

shall ensure availability of all pertinent records for checking/review of CHD Director or his authorized representative(s)

A

Licensee

56
Q

prescribes the standards,
criteria and technical requirements for the issuance of LTO, shall be utilized

A

Inspection Tool

57
Q

T/F: Inspection is not announced for old (after 1 yr) labs

A

T

57
Q

T/F: Inspection for new (1st time) labs are announced

A

T

58
Q

shall suspend, cancel or revoke and may seek any law enforcement agency to execute the closure of any erring lab when
necessary

A

HFSRB/CHD Director/Rep

59
Q

Who investigates the complaint?

A

HFSRB/CHD Director/Rep

59
Q

Penalties for clinical laboratories in a hospital will be
governed by ________, dated _____,
titled ______________

A

AO No. 2007- 0022
June 6, 2007
“Violations under the One-Stop Shop Licensure System (OSSOLS) for Hospitals”

60
Q

Owned, established and operated with funds through donation, principal, investment or other means by any individual corporation, association or organization

A

Private

61
Q

Within the premises or compound of the hospital

May be part of general clinical laboratory but with designate

A

Hospital-based

61
Q

Located outside the premises or compound of a hospital and independently functioning on its own

A

Non-hospital based

62
Q

Minimum number of personnel

A

7

1 Patho
3 Analysts (3 RMTs / 2 MTs & 1 Allied Health w/ training)
1 Lab Aide
1 Receptionist
1 Encoder

62
Q

With training in Infectious
Disease and Molecular
Diagnostics / Infectious
Disease Specialist

A

Pathologist

63
Q

Reagent Preparation

A

● PCR cabinet / laminar flow
● 4°C refrigerator for reagents
● -20°C freezer for reagents
● Microcentrifuge
● Vortex mixer
● Minifuge
● Cold rack for PCR tube
● Set of four adjustable-volume micropipettes with rack
○ 100-1000 uL
○ 20-200 uL
○ 2-20 uL
○ 0.5-10 uL
● Micropipette tips
● Gloves in different sizes (S, M, L)

64
Q

Specimen Preparation

A

Biological Safety Cabinet Class II Type A2

64
Q

used to protect personnel,
products and the environment from exposure to biohazards and cross contamination during routine procedures.

A

Biological Safety Cabinets

64
Q

provide a partial barrier for the safe manipulation of low, moderate and high-risk microorganisms.

most frequently used in research and clinical laboratories, are divided into four types (Types A1, A2, B1 and B2).

A

Class II BSCs

65
Q
A
66
Q
A
67
Q

1st Offense

A

Stern Warning

67
Q

3rd Offense

A

P50,000

67
Q

2nd Offense

A

P30,000

67
Q

4 Offenses

A

Revocation of DOH-LTO

67
Q

If offender is a firm or corporation, the ________ and/or owner(s) shall be liable to the penalty imposed

A

managing head

68
Q

Any person who operates a CL without securing the necessary DOH-PTC and corresponding DOH-LTO shall be issued a Cease-and-Desist Order (CDO) and shall
pay the administrative penalty of

A

P50,000

68
Q

Amplification / PCR

A

● Real-time PCR machine
● Conventional PCR machine
● Minifuge
● Computer and printer (associated with the real-time
PCR machine)
● -20°C or -40°C freezer for storage of PCR products
● Real-time PCR machine
● Conventional PCR machine

68
Q

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

A

Administrative Order No. 2020-0014

[MT 6313] MTLaws (5 decks)

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