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

Question 1

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

Answer 1

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

Question 2

When was RA 7719 approved?

Answer 2

May 5, 1994

Question 3

According to this law, blood donation is a ________ act

Answer 3

Humanitarian

Question 4

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

Answer 4

National Voluntary Blood Services Program (NVBSP)

Question 5

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

Answer 5

AO 9 s. 1995

Question 6

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

Answer 6

Chapter 8

Question 7

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

Answer 7

AO 17-A s. 1998

Question 8

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

Answer 8

2003

Question 9

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”

Answer 9

AO 2005-0002

Question 10

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

Answer 10

5 and 6

Question 11

AO 2005-0002 established what council?

Answer 11

National Council for Blood Services

Question 12

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

Answer 12

AO 2005-0002

Question 13

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

Answer 13

AO 2008-0008 (most current AO)

Question 14

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

Answer 14

AO 2008-0008

Question 15

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

Answer 15

False (even private)

Question 16

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

Answer 16

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

Question 17

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

Answer 17

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

Question 18

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

Answer 18

1. Blood station
2. Blood collection units
3. Blood bank
4. Blood center

Question 19

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”

Answer 19

All

Question 20

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”

Answer 20

B, C, and E

Question 21

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”

Answer 21

B, C, and E

Question 22

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)”

Answer 22

E

Question 23

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”

Answer 23

E

Question 24

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”

Answer 24

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

> D and E (whole blood and blood components)

Question 25

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"

Answer 25

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

Question 26

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)"

Answer 26

D only

Question 27

What constitutes Section 7?

Answer 27

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

Question 28

What constitutes Section 8?

Answer 28

Non-profit operation

Question 29

What constitutes Section 9?

Answer 29

Regulation of Blood Banks

Question 30

What is the penalty for overpricing blood products?

Answer 30

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

Question 31

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

Answer 31

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

Question 32

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

Answer 32

10 years of imprisonment

Question 33

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

Answer 33

Blood Service Facility (BSF)

Question 34

Services must conform to what manual of the DOH?

Answer 34

Manual of Standards

Question 35

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

Answer 35

Minimum

Question 36

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

Answer 36

National Voluntary Blood Services Program (NVBSP)

Question 37

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

Answer 37

Blood Service Facility (BSF)

Question 38

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

Answer 38

Hospital Blood Transfusion Committee (HBTC)

Question 39

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

Answer 39

False (National Voluntary Blood Services Program or NVBSP)

Question 40

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

Answer 40

One-Stop-Shop Licensure for Hospitals

Question 41

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)

Answer 41

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

Question 42

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

Answer 42

Center for Health Development (CHD)

Question 43

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

Answer 43

False

Question 44

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

Answer 44

False (AT ALL TIMES)

Question 45

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

Answer 45

15

Question 46

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

Answer 46

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

Question 47

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

Answer 47

False (must be separate)

Question 48

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

Answer 48

3 years (for a SEPARATE blood service facility)

Question 49

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

Answer 49

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

Question 50

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

Answer 50

1 year

Question 51

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

Answer 51

January 1 to December 31 of the SAME YEAR

Question 52

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

Answer 52

Commercial Blood Banks (64.4%)

Question 53

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

Answer 53

99.6%

Question 54

What percentage of private donors were remunerated (paid)?

Answer 54

77%

Question 55

This AO refers to the Revised Blood Banking Guidelines

Answer 55

AO 57 s. of 1989

Question 56

This AO refers to Institutionalizing the NVBSP

Answer 56

AO 118-A

Question 57

What was the old Blood Banking Law?

Answer 57

RA 1517 (in the year 1956)

Question 58

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

Answer 58

Constitutional Right

Question 59

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?

Answer 59

National Blood Transfusion Service Network

Question 60

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

Answer 60

False (patients who CAN afford)

Question 61

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

Answer 61

True

Question 62

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

Answer 62

False (MANDATORY upgrade, not encouraged)

Question 63

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

Answer 63

Blood/blood product

Question 64

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

Answer 64

Blood banks and Blood centers

Question 65

A blood bank that exists for profit

Answer 65

Commercial blood bank

Question 66

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

Answer 66

Hospital-based blood bank

Question 67

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

Answer 67

Blood collection unit

Question 68

One who donates blood on their own volition without monetary compensation

Answer 68

Voluntary blood donor

Question 69

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

Answer 69

Blood transfusion transmissible disease

Question 70

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

Answer 70

Secretary of Health

Question 71

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

Answer 71

Walking blood donor

Question 72

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

Answer 72

Blood Service Facility (BSF)

Question 73

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

Answer 73

Blood Station

Question 74

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

Answer 74

Blood Collection Unit

Question 75

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

Answer 75

Blood Bank

Question 76

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

Answer 76

Blood Center

Question 77

Give the 5 transfusion transmissible infections screened by blood centers

Answer 77

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

Question 78

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

Answer 78

False (blood centers)

Question 79

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

Answer 79

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

Question 80

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

Answer 80

RA 11166 - Philippine HIV and AIDS Policy

Question 81

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

Answer 81

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

Question 82

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

Answer 82

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

Question 83

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

Answer 83

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

Question 84

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

Answer 84

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

Question 85

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

Answer 85

Blood Collection Unit and Blood Stations

Question 86

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

Answer 86

Blood Bank or Blood Center

Question 87

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

Answer 87

HFSRB or CHD of the DOH

Question 88

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

Answer 88

30

Question 89

Who inspects and monitors BSFs?

Answer 89

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

Question 90

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

Answer 90

International Society of Blood Transfusion (ISBT)

Question 91

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

Answer 91

1982

Question 92

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

Answer 92

Apheresis

Question 93

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

Answer 93

True

Question 94

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

Answer 94

1 year

Question 95

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

Answer 95

Attending physician