Philippine Blood Banking Law
Philippine Blood Banking Law
Philippine Blood Banking Law
A. RA 1517 s. 1956
B. RA 7719 s. 1994
C. AO 9 s. 1995
D. TECHNICAL STANDARDS FOR BLOOD BANKS
IN THE PHILIPPINES
E. AO 2010-0001
F. AO 2010-0002
TITLE
RA 1517 RA 7719 AO NO.9 S.1995
AN ACT AN ACT PROMOTING RULES AND
REGULATING THE VOLUNTARY BLOOD REGULATIONS
COLLECTION, DONATION, IMPLEMENTING
PROCESSING AND PROVIDING FOR AN REPUBLIC ACT NO.
SALE OF HUMAN
BLOOD, AND THE ADEQUATE SUPPLY OF 7719 OTHERWISE
ESTABLISHMENT SAFE BLOOD, KNOWN AS THE
AND OPERATION OF REGULATING BLOOD "NATIONAL BLOOD
BLOOD BANKS AND BANKS, AND SERVICES ACT OF
BLOOD PROVIDING PENALTIES 1994"
PROCESSING FOR VIOLATION
LABORATORIES THEREOF
EFFECTIVITY DATE
RA 1517 RA 7719 AO NO.9 S.1995
– Process
– Store
– transport and issue blood for transfusion
– provide information and/ or education on blood
transfusion transmissible diseases
Blood collection unit
• PRC
– Encourage all medical and other health
professional associations and societies esp. those
accredited by the PRC, to conduct training on
rational use of blood and blood products including
the benefits of voluntary blood donation as part of
CPE
Role of PRC and DOH in the promotion of
voluntary blood donation
• DOH
– Ensure the conduct of training on rational blood
use of blood and blood products, on the practice
of blood transfusion medicine and on the merits
of voluntary blood donation for the health
personnel
Categories of Blood Bank/Center
• Non hospital based Category A
• Non hospital based Category B
• Hospital based Category A
• Hospital based Category B
BLOOD DONOR QUALIFICATIONS
• Weight of more than 45kg (100lbs) for 250ml of donated
blood, 50kg (110lbs) for 450mlof donated blood.
• Must be in Good Health
• Aged 16- 65 years of age (16 and 17 years needs parental
consent)
• Blood Pressure must be on safe range, Systolic Bp of 90- 160
mmHg and Diastolic Bp of 60- 100 mmHg
• Hemoglobin must be at least 125g/L (12.5g/dl)
Requirements for New License
1. Minimum number & qualification of trained personnel
2. Staff development plan
– BB shall prepare a 1 yr staff development plan
3. Physical facilities equipment and supplies
4. Biosafety
5. Quality Control
6. Recording, reporting & documentation requirements
7. Blood distribution and transportation requirements
8. Blood transfusion committee
9. Preventive services
10.Networking
Requirements for Renewal License
1. Technical staff shall have passed the basic proficiency test
the previous year
2. BB shall have achieved at least 70% of the staff
development plan targets
3. BB shall have bled only voluntary blood donors the
previous years
4. Annual report shall have been submitted on or before
January 31 of the succeeding yr
5. Inspection visit shall have confirmed that BB has
continued to operate under good physical conditions
6. BB has been shown to collect only the allowable services
fee for each blood unit dispensed
LICENSING PROCESS
1. Initial process
2. Application for renewal of license
3. Inspection
4. Time table for application and inspection
5. Release
TECHNICAL STANDARDS
GOVERNING THE COLLECTION,
PROCESSING & PROVISION OF
HUMAN BLOOD & THE
ESTABLISHMENT & OPERATION OF
BLOOD BANKS IN THE PHILIPPINES
TITLE
PRIMARY 20 sq m 20 sq m
SECONDARY 30 sq m 40 sq m
TERTIARY 40 sq m 50 sq m
• EQUIPMENT/ FURNITURE
• GLASS WARE/ REAGENTS/ SUPPLIES
• DONOR REQUIREMENTS (SCREENING)
• COLLECTION OF BLOOD/LABELLING
– A. COLLECTION OF BLOOD
– B. LABELLING
A. COLLECTION OF BLOOD
1. Methods
• Aseptic methods using sterile, closed system & a single
venipuncture
2. Protection against contamination
• Sealing, tube segments,
• If more than 1 skin puncture is needed, another set &
container must be used
3. Donor reactions
• instruct donor for prevention & treatment for donor
reactions
• there should be medical care for donors who sustain
adverse reaction
• COLLECTION OF BLOOD/LABELING cont.
4. Anticoagulants & additives
• Anticoagulants & additives should be in the prescribed
amount in relation to the volume of blood to be collected
5. Temperature
• Blood shall be stored immediately after collection at a
temperature between 2ᴼC
• if it is to be used as a source of platelets store at 20-40ᴼC
for not more than 6 hours
6. Reissued blood
• blood that has been returned to BB shall not be reissued
(unless proper handling of blood are met)
B. LABELING
10.Laboratory records
– Actual results and final interpretation shall be
recorded
B. STORAGE OF BLOOD & COMPONENTS
1. RBC
– Stored & transported at 2ᴼC-6ᴼC
2. PLATELET CONCENTRATE
– Stored at room temperature 20ᴼC-24ᴼC with
continuous agitation throughout the storage period
3. CRYOPRECIPITATE
– If maintained constantly in the frozen state at -30ᴼC
no longer than 12 months from the date of
phlebotomy
4. PLASMA
– Liquid plasma may be store at 2ᴼC-6ᴼC for no more
than 5 days; (-30ᴼC up to 5 years)
SPECIFICATION FOR BLOOD
COMPONENTS/PRODUCTS
1. RED BLOOD CELL COMPONENTS
a) RED BLOOD CELLS
• Separated from plasma through centrifugation
b) WASHED RBCs
• remove residual plasma proteins cytokines or
antibodies that may be the cause of the reactions
• Shall be used within 12 hours
c) LEUKOCYTE-POOR RBC
• 70% of the original WBCs are removed
• Removed by filtration, centrifugation, washing
SPECIFICATION FOR BLOOD COMPONENTS/PRODUCTS cont.
2. EXTERNAL CONTROL
– All BB shall participate in EQAP