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MTLBE > RA 4688 and RA 7719 > Flashcards

RA 4688 and RA 7719 Flashcards

1
Q

**In order to maintain quality in our laboratory services, there
should be involvement by the government

A
  • Regulation by the government
  • Clinical laboratories should follow standards in their
    operation and in providing laboratory services
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2
Q

**Apart from international regulations, the government itself has
its own laws in place

A
  • Minimum requirements only
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3
Q

Whether in hospitals or not (Red Cross)

A

**Blood banks should also follow standards

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4
Q

Clinical Laboratory Act of 1966

A

**RA 4688

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5
Q
  • Will specify provisions of the law
    o Specific meaning
    o Scope
A

**Implementing Rules and Regulations (IRR)

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6
Q

“An Act Regulating the Operation and Maintenance of
Clinical Laboratories and Requiring the Registration of
the Same with the Department of Health, Providing
Penalty for the Violation Thereof, and for Other
Purposes”  complete title

A

Clinical Laboratory Act of 1966

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7
Q

Clinical Laboratory Act of 1966 Approved on:

A

June 18, 1966

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8
Q

DOH: Implementing Agency of health-related
laws
 Issues IRR  guidelines

A

UPDATED by several IRR

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9
Q
  • There is a “…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

AO #37 series 2021
- Approved on: June 11, 2021

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10
Q

Shall serve as the new guidelines in licensing diagnostic clinical
laboratories in the Philippines

A

AO 37 ser. 2021

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11
Q

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

o Facility that is involved in the
 (a) pre-analytical
 (b) analytical
 (c) post-analytical procedures

A

Clinical Laboratory (CL)

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12
Q

SCL

A

satellite clinical laboratory

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13
Q

mobile clinical laboratory

A

MCL

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14
Q

Are medtechs allowed to supervise CL?

A

No, that is not the scope of our profession

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15
Q

Are medtechs allowed to supervise CL?

A

No, that is not the scope of our profession

**Kapag walang pathologist, the lab may be supervised a nonpathologist physician (dating AOs)

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16
Q

 Renew license here
 With inspection of DOH personnel

A

Center for Health Development

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17
Q

o Must be registered in HSFRB
o Registration permit  no inspection
o Shall be placed in an area that can readily be
seen by the public at all times

A

Research/academic labs

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18
Q

 Apply for new license if:
 New owner
 Transfer of location

A

Non-transferable

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19
Q

Changes: name, ownership, headship, inform DOH within

A

15 days

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20
Q

 License Validity
- DOH-LTO:
 Whether hospital-based or freestanding

A

valid for 1 year

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21
Q

 DOH has a scheduling
scheme in renewing license
of CL

A

After 1 year, should renew

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22
Q

90 days before expiration
date
(busy starting October)

A

Dec. 31st of the year

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23
Q

Required to register with the DOHHFSRB every 3 years

A

COR of CL operated for research and training

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24
Q

o A program where participating CL are given
unknown samples for analysis (by reference
labs)

o Samples should be treated as ordinary human
specimens for the usual processing and
examination

o The quality of performance of the CL shall be
assessed through the closeness of its results to
the pre-determined value (reference value)
generated by the participating CL through peer
group analysis

A

External Quality Assessment Program

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25
Q

o Best practice to maintain quality of lab and
check skills of MTs
o Need maipasa per section ng lab

A

National External Quality Assessment Scheme

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26
Q
  • Operating CL without LTO-CL
    o Issuing fraudulent lab test results knowingly,
    willfully, or through gross negligence
    **Penalty: up to 50,000 pesos
    **Revocation or suspension of license
A

Violation

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27
Q
  • All existing licensed CL
  • For new CL
A

Transitory Provision

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28
Q

shall be given 3 years to
comply with the physical plant requirements from the
date of effectivity of this Order

A

All existing licensed CL

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29
Q

shall be given _____ to fully
offer the additional services for each category with
corresponding personnel and equipment from the date of
effectivity of this Order

A

2 years

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30
Q

shall be given_____ to
comply with the physical plant requirements from the
date of effectivity of this Order

A

3 years

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31
Q

this Order shall be immediately applicable
 Habang pinaplano, i-adapt na nila
yung nasa new IRR

A

For new CL

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32
Q

 Do not qualify in the scope of the law
 Research
 Academic
 Genetics for research
 Immunohematology/Blood bank
 Has separate regulation
 Don’t need to follow this IRR

A

Special CL

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33
Q

same as AO 27 series 2007
o Private
o Government-owned

A

By ownership

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34
Q

same as AO 27 series 2007
o Free-standing
o Institution-based (hospital-based)

A

By institutional character

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35
Q

o Clinical pathology
o Anatomic pathology
o + Molecular pathology

A

By functions

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36
Q

Deals with the analysis of certain
genes, proteins and other molecules in samples from organs, tissues or bodily
fluids in order to diagnose disease and/or to guide the prevention and treatment of disease based on the principles, techniques and tools of molecular biology as they are applied to diagnostic medicine in the lab

A

+ Molecular pathology

37
Q

o Primary
o Secondary
o Tertiary
o Limited-service

A

By service capabilities

38
Q
  • Primary
  • Secondary
  • Tertiary
  • Limited
A

Lab Services

39
Q

Kung ano nakalista

40
Q

o Primary + yung nakalista sa kanya

41
Q

o Primary + secondary + nakalista sa kanya

42
Q

o Do not follow minimum services of primary,
secondary, and tertiary CL
o Designed to cater needs of specific needs
o Ex. Hemodialysis, Cancer center, Malarial
center

43
Q

Minimum number of Lab personnel
- Primary:

A

o Private: at least 8 RMTs
o Government: at least 9 RMTs

44
Q

Minimum number of Lab personnel
Secondary

A

at least 12 RMTs
o Regardless if private or government

45
Q

Minimum number of Lab personnel
Tertiary

A

o At least 12 RMTs without histopathology
o At least 13 RMTs for hospital-based

46
Q

at least 1 RMT per section

47
Q

at least 3 RMTs (depend on services offered)

48
Q
  • Stationed in San Lazaro Hospital
  • Provides training for HIV testing
A

**SACCL – STD AIDS COOPERATIVE CENTRAL
LABORATORY

49
Q
  • Training provided by the National Tuberculosis
    Research Laboratory
A

**DSSM – DIRECT SPUTUM SMEAR MICROSCOPY

50
Q

RITM

A

RESEARCH INSTITUTE FOR TROPICAL
MEDICINE

51
Q
  • Provides service for genetics, immuno/hematopathology
    and infectious diseases
  • COVID-19 testing laboratories shall be covered by
    another AO
A

Clinical Laboratory for Molecular Pathology only

52
Q

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

*Before molecular testing, antibody testing was only done

A

AO #14 series 2020

53
Q

AO #14 series 2020
Approved on:

A

April 7, 2020

54
Q

6 months to produce
antibodies might become false
positive

AO #14 series 2020

55
Q

Health facility where COVID-19 testing is done on specimens from the human body to obtain
info about the health status of a patient for the prevention, diagnosis, and treatment of disease

A

COVID-19 Testing Laboratory

56
Q

Whether free-standing or hospital-based

A

Laboratory should be a DOH-LTO holder

57
Q
  1. Laboratory should be a DOH-LTO holder
  2. LTO is issued upon full compliance to standards and
    requirements of RITM and CHD-RLED
  3. DOH-LTO of a hospital-based COVID-19 testing lab
    should be subsumed in the LTO of the hospital
  4. DOH-LTO of non-hospital-based
  5. COVID-19 testing lab should have a separate unit
    with its own designated working area
  6. Should follow strict biosafety and biosecurity
    guidelines
A

General guidelines
AO #14 series 2020

58
Q

a. Existing LTO
 Can put up COVID-19 testing lab as
long as they are approved by DOH
b. With COR by DOH or w/o DOH
 Shall be issued as COVID-19 testing
lab with limited-service capability

A

DOH-LTO of non-hospital-based

59
Q

Can put up COVID-19 testing lab as long as they are approved by DOH

A

Existing LTO

60
Q

Shall be issued as COVID-19 testing lab with limited-service capability

A

With COR by DOH or w/o DOH

61
Q

o Separate performance of procedures to avoid
cross-contamination
o Extraction (most dirty)  reagent preparation 
PCR
 If only 1 person will do that, process is
prone to contamination

A

Situation: PCR

62
Q

clinical pathologist with training in Molecular Laboratory Diagnostics

63
Q

should have appropriate trainings
prescribed by RITM

 3 RMTs or 2 RMTs and 1 molecular
biologist

64
Q

Cleans the lab to avoid contamination

A

1 full-time lab aide: per 8-hr shift

65
Q

o Receiving area
o Encodes patient info

A

1 full-time receptionist: per 8-hr shift

66
Q

Encodes result

A

1 full-time encoder: per 8-hr shift

67
Q
  • Proficient in molecular biology techniques, biosafety, and
    biosecurity
  • Should undergo fit testing
  • Shall have annual medical examination
  • Shall have continued updated training in biosafety,
    biosecurity, new techniques and technologies
A

Minimum requirement for staff

68
Q

Minimum requirement for staff
Should undergo fit testing

A

o Respirator with at least 95% efficiency ( N95 mask)
o Person will breathe through their mouth while
wearing respirator

69
Q

Shall have annual medical examination

A

With influenza vaccination

70
Q

Must pass EQAS
o Swab samples are given to the lab by RITM
o Lab should test samples and report results to
RITM
k Report value of gene detected in PCR

A

Quality improvement activities

71
Q
  • Logbook
  • Laboratory Information System
  • Processes and concerns must be well-documented
A

Information management

72
Q
  • HFSRB
  • CHD-RLEDs
A

Licensing Requirement

73
Q

o Based in Level 2 and 3 hospitals and specialty
hospitals

74
Q

Non-hospital-based labs and Level 1 hospitals

75
Q

LTO is valid for

A

1 year only

76
Q

The enactment of RA 4688 otherwise known as “Clinical
Laboratory Act of 1966” took place on
A. June 16, 1966
B. July 18, 1966
C. June 18, 1966
D. February 13, 1966

A

C. June 18, 1966

77
Q

Regular inspection of clinical laboratories is done every
________?

A

o Every 2 years

78
Q

Are MT allowed to supervise CL?

A

No
 MT can own and work in lab but not
manage
 Pathologists manage the lab

79
Q

Crystal Lab is a tertiary, privately owned laboratory
whose main lab is situated in Makati. It has branch labs
in:
 E. Rodriguez Ave., Quezon City
o Tertiary category
 Binondo, Manila
o Tertiary Category
 Taft Ave., Pasay City
o Secondary Category
**Which of these would require a license to operate?

A. Only the main lab in Makati
B. Main lab + the 2 tertiary branch lab
C. Main lab + secondary CL
D. Main labs + all the branch labs

A

D. Main labs + all the branch labs

80
Q

Validity of license to operate laboratories?

A

o 1 year only

81
Q

A clinical laboratory installed a dialysis center performing
lab tests limited to creatinine and BUN determinations is
classified as:

A

Limited-service CL

82
Q

Most recent implementing rules and regulations for RA
4688

A

AO #37 series 2021

83
Q

All clinical pathology reports must be kept on file in the
laboratory for how long?

A

At least 1 year

84
Q

Clinical pathology reports: kept on file for

A

at least 1 year

85
Q

Anatomic pathology reports:

A

permanently kept on file

86
Q

Where should a clinical lab secure/renew its license to
operate?
A. DOH-BHFS
B. DOH-CHD
C. Either
D. Neither

87
Q

How long is the license of clinical labs performing
diagnostic tests valid?
A. 1 year
B. 2 years
C. 3 years
D. Lifetime

88
Q

Mandatory personnel of clinical laboratory:
A. Medical Technologist
B. Laboratory technician
C. Pathologist
D. A and C

A

A. Medical Technologist
C. Pathologist

89
Q

The application for renewal of license to operate clinical
laboratories begin _____ days before expiration day
A. 20
B. 60
C. 30
D. 90

MTLBE (15 decks)

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