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MTLBE > (M) L1.2: RA 7719 - National Blood Services Act of 1994 > Flashcards

(M) L1.2: RA 7719 - National Blood Services Act of 1994 Flashcards

1
Q

This promotes voluntary blood donation to provide sufficient supply of safe blood and to regulate blood banks. It aims to inculcate public awareness that blood donation is a humanitarian act

A

RA 7719 - National (Voluntary) Blood Services Act of 1994

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2
Q

When was RA 7719 approved?

A

May 5, 1994

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3
Q

According to this law, blood donation is a ________ act

A

Humanitarian

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4
Q

This program of the DOH targets the youth as volunteers in blood donation

A

National Voluntary Blood Services Program (NVBSP)

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5
Q

This AO formulates the “Rules and Regulations Implementing RA 7719”

A

AO 9 s. 1995

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6
Q

What chapter of AO 9 s. 1995 addresses the regulation of blood services by the Bureau of Research and Laboratories?

A

Chapter 8

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7
Q

This AO is otherwise known as the “Requirements and Procedures for a License to Operate a Blood Bank in the Philippines”

A

AO 17-A s. 1998

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8
Q

The “Rules and Regulations Governing Authorization of BCU and BS in the Philippines” was formulated and approved in what year?

A

2003

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9
Q

This AO stands for the “Rules and Regulations for the Establishment of the Philippine National Blood Services Amending Pertinent Provisions of AO 9 s. 1995”

A

AO 2005-0002

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10
Q

AO 2005-0002 was formulated pursuant to what sections of RA 7719?

A

5 and 6

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11
Q

AO 2005-0002 established what council?

A

National Council for Blood Services

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12
Q

This AO defined the new functions and/or service capabilities of the different blood service facilities including hospital blood banks/blood centers

A

AO 2005-0002

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13
Q

This AO stands for the “Rules and Regulations Governing the Regulation of Blood Service Facilities”

A

AO 2008-0008 (most current AO)

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14
Q

This AO was promulgated to protect and promote the health of people by ensuring available licensed blood service facilities with adequate staff, equipment, and resources to perform their functions safely, efficiently, and effectively

A

AO 2008-0008

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15
Q

T or F: The rules and regulations only apply to the government blood service facilities engaged in blood banking and transfusion

A

False (even private)

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16
Q

What are the 2 classifications of Blood Service Facilities based on ownership?

A
  1. Government
  2. Private (Hospital-based BSF only)
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17
Q

What are the 2 classifications of Blood Service Facilities based on institutional character?

A
  1. Hospital-based
  2. Non-hospital based (government/PNRC owned only)
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18
Q

What are the 4 classifications of Blood Service Facilities based on service capabilities?

A
  1. Blood station
  2. Blood collection units
  3. Blood bank
  4. Blood center
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19
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Advocacy and promotion of voluntary blood donation”

A

All

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20
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Recruitment, screening, and collection of blood from voluntary donors”

A

B, C, and E

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21
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Conduct health education and counseling”

A

B, C, and E

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22
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Testing units of blood for transfusion transmissible infections (TTI)”

A

E

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23
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Processing and provision of blood components”

A

E

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24
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Storage, issuance, transport, and distribution of blood units to hospitals and other health facilities”

A

> A and C (whole blood and packed RBC only)

> D and E (whole blood and blood components)

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25
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Compatibility testing of red cell units”

A

A, B, and C (if hospital-based) + D

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26
Q

Identify whether these functions are performed by:

A. Blood station
B. Blood collection unit
C. Both blood station and collection unit
D. Blood bank
E. Blood center

“Compatibility testing of red cell units, direct Coombs test, red cell antibody screening, investigation of transfusion reactions, and assistance to the Hospital Blood Transfusion Committee of post-transfusion surveillance (hemovigilance)”

A

D only

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27
Q

What constitutes Section 7?

A

Phase-out of Commercial Blood Banks (they are given 2 years after the effectivity of RA 7719)

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28
Q

What constitutes Section 8?

A

Non-profit operation

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29
Q

What constitutes Section 9?

A

Regulation of Blood Banks

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30
Q

What is the penalty for overpricing blood products?

A

1-6 months of prison with a fine of 5,000-50,000

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31
Q

What is the penalty for having no license/authority to operate?

A

12-20 years of prison with a fine of 50,000 to 500,000

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32
Q

What is the penalty for a MT’s failure to dispose of contaminated blood units?

A

10 years of imprisonment

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33
Q

Which agency appoints and allocates personnel who are suitable, qualified, skilled and/or trained to assume the responsibilities, authority, accountability and function of the position

A

Blood Service Facility (BSF)

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34
Q

Services must conform to what manual of the DOH?

A

Manual of Standards

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35
Q

All reagents and glassware to be used by the BSF shall be based on the ___________ requirement for sensitivity and specificity of testing reagents

A

Minimum

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36
Q

Testing procedures shall be recommended by the technical committee of what?

A

National Voluntary Blood Services Program (NVBSP)

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37
Q

This organization shall participate in an External Quality Assessment Program Administered by the designated National Reference Laboratories (NRL) or other external assessment program approved by the DOH–NVBSP

A

Blood Service Facility (BSF)

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38
Q

All hospital-based blood banks, blood collection units, and/or blood stations shall establish what?

A

Hospital Blood Transfusion Committee (HBTC)

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39
Q

T or F: All Blood Service Facilities shall comply with the policies and guidelines of the Bureau of Health Facilities and Services

A

False (National Voluntary Blood Services Program or NVBSP)

40
Q

Hospital-based blood banks, blood collection units, and blood stations shall be licensed/authorized to operate through what system?

A

One-Stop-Shop Licensure for Hospitals

41
Q

T or F: Blood banks, collection units, and stations licensed by the One-Stop Shop Licensure system are required to obtain a separate license to operate/authorization to operate (hospital-based)

A

False (no need; it may use the license of the hospital itself)

42
Q

The requirements for the licensure of blood banks or authorization of blood collection units/blood stations shall be submitted where?

A

Center for Health Development (CHD)

43
Q

T or F: The LTO/ATO can be assigned/transferred directly or indirectly to other parties

44
Q

T or F: The LTO/ATO must be displayed only during operation times at a prominent place within the premises

A

False (AT ALL TIMES)

45
Q

The CHD shall be notified within how many calendar days of any change in management, name, and ownership of a blood service facility?

46
Q

T or F: If a blood service facility transfers location, there is no need for a new application for an LTO/ATO

A

False (it is required to apply for a new one)

47
Q

T or F: BSFs in different locations but operated under the same management can be under the same LTO/ATO

A

False (must be separate)

48
Q

The validity of the LTO/ATO is for how long?

A

3 years (for a SEPARATE blood service facility)

49
Q

When does the validity of an LTO/ATO begin and end?

A

January 1 of the first year of validity to December 31 of the third year of validity

50
Q

For the One-Stop-Shop Licensing System, the LTO/ATO shall be valid for how long?

51
Q

When does the validity of a One-Stop-Shop license begin and end?

A

January 1 to December 31 of the SAME YEAR

52
Q

Out of the blood units collected in 1992, which garnered the highest percentage in terms of source?

A

Commercial Blood Banks (64.4%)

53
Q

What percentage of commercial blood bank donors were remunerated (paid)?

54
Q

What percentage of private donors were remunerated (paid)?

55
Q

This AO refers to the Revised Blood Banking Guidelines

A

AO 57 s. of 1989

56
Q

This AO refers to Institutionalizing the NVBSP

57
Q

What was the old Blood Banking Law?

A

RA 1517 (in the year 1956)

58
Q

The need for regulating blood bank practice stems from the ________ to health and people

A

Constitutional Right

59
Q

RA 7719 wants to mandate the DOH to establish what network in order to rationalize and improve the provision of adequate and safe supply of blood?

A

National Blood Transfusion Service Network

60
Q

T or F: In order to provide non-profit blood services, it can either be through reimbursements from patients who can’t afford to pay or donations from governmental or non-governmental entities

A

False (patients who CAN afford)

61
Q

T or F: All blood banks/centers are required to operate on a non-profit basis

62
Q

T or F: Blood banks/centers are encouraged to include preventive services and education to control the spread of blood TTI’s

A

False (MANDATORY upgrade, not encouraged)

63
Q

This refers to human blood, processed or unprocessed, and includes blood components, its products, and derivatives

A

Blood/blood product

64
Q

A lab or institution with the capability to recruit and screen donors, collect, process, store, transport, and issue blood for transfusion and provide education on blood TTI’s

A

Blood banks and Blood centers

65
Q

A blood bank that exists for profit

A

Commercial blood bank

66
Q

A blood bank located within the hospital which can perform compatibility testing

A

Hospital-based blood bank

67
Q

An institution/facility authorized by the DOH to recruit and screen donors to collect blood from

A

Blood collection unit

68
Q

One who donates blood on their own volition without monetary compensation

A

Voluntary blood donor

69
Q

Collective term for diseases which may be transmitted as a result of blood transfusion

A

Blood transfusion transmissible disease

70
Q

This government official has the responsibility of carrying out the provisions of this act

A

Secretary of Health

71
Q

An individual included in the list of qualified donors who is ready to donate when needed in their community

A

Walking blood donor

72
Q

This is a unit, agency, or institution that provides blood products

A

Blood Service Facility (BSF)

73
Q

BSF Service Capability Classifications:
- Provision of whole blood and packed red cells
- Storage, issuance, transport, and distribution of whole blood and packed red cells

A

Blood Station

74
Q

BSF Service Capability Classifications:
- Recruitment, retention, and care of voluntary blood donors
- Screening and selecting blood donors
- Conduct of health education and counseling services
- Collection of blood (mobile or facility-based) from qualified donors
- Transport of blood to blood centers for testing and processing

A

Blood Collection Unit

75
Q

BSF Service Capability Classifications:
- Storage and issuance of whole blood and blood components obtained from a blood center

A

Blood Bank

76
Q

BSF Service Capability Classifications:
- Testing of units for TTIs
- Processing and provision of blood components
- Storage, issuance, transport, and distribution of whole blood units and/or blood products to hospitals or other health facilities

A

Blood Center

77
Q

Give the 5 transfusion transmissible infections screened by blood centers

A
  1. HIV (determination of anti-HIV 1 or 2)
  2. Hepatitis B (determination of HbsAg)
  3. Hepatitis C (determination of anti-HCV)
  4. Malaria
  5. Syphilis
78
Q

T or F: Testing of TTIs is only done in blood banks

A

False (blood centers)

79
Q

T or F: Once the blood is screened by BCs, the same samples can be retested by the end-user hospitals and other health facilities

A

False (CANNOT; the BCs are responsible for testing and making sure that the units are negative for TTIs)

80
Q

What law states that a second testing for HIV may be requested by the recipient of the blood as a matter of right?

A

RA 11166 - Philippine HIV and AIDS Policy

81
Q

T or F: The prohibition for retesting of blood shall only apply to HIV

A

False (Hepa B-C, syphilis, and malaria)

82
Q

For hospital-based blood donations, who should manage the BLOOD STATIONS?

A

Pathologist certified by the Philippine Board of Pathology of the Philippine Society of Pathologists

83
Q

For non-hospital-based blood donations, who should manage the BLOOD STATIONS?

A

Physician with at least 3 months of formal training in basic blood banking (the training provider must be DOH-recognized)

84
Q

Who are 2 possible heads of BLOOD CENTERS and BLOOD BANKS?

A
  1. Pathologist certified by the Philippine Board of Pathologists
  2. Hematologist certified by the Philippine Board of Hematology (with experience in a BSF)
85
Q

An Authority to Operate (ATO) is issued to what facilities?

A

Blood Collection Unit and Blood Stations

86
Q

A License to Operate (LTO) is a formal authority issued to what facilities?

A

Blood Bank or Blood Center

87
Q

The application for registration and issuance of ATO/LTO is filed with what 2 possible organizations?

A

HFSRB or CHD of the DOH

88
Q

The CHD shall conduct an inspection of the BSF within how many days from the time of filing for an application?

89
Q

Who inspects and monitors BSFs?

A

The Directors/Authorized Representatives of HFSRB and CHD (within their respective jurisdiction)

90
Q

Which organization revised new blood regulation guidelines after a discovery of new infectious diseases (first AIDS/HIV patient in the PH) in 1984?

A

International Society of Blood Transfusion (ISBT)

91
Q

In what year was the first recorded case of HIV for an infant?

92
Q

This is a technology that separates donated blood components to treat certain illnesses

93
Q

T or F: Any positive results released by the blood center shall be FINAL

94
Q

If the blood center is hospital-based, one may use the hospital’s license which is valid for how long?

95
Q

A staff may collect blood for donation EVEN WITHOUT an LTO/ATO as long as there is a directive from who?

A

Attending physician

MTLBE (30 decks)

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