STANDARDS FOR BLOOD BANKS &

BLOOD CENTERS
GENERAL PRINCIPLES:

1. All BBs & BCs should place highest priority in the health and
safety of their donors, patients, personnel & the community.
2. All Blood Service Facilities (BSF) shall achieve and maintain
100% voluntary blood donation.
3. These Standards should be regarded as performance goals to be
attained and maintained by each BB and BC.
4. Inspection and licensing should take into account the capability
and commitment of the BB/BC to continuously improve the
safety and quality of its services & products.
5. Every person involved in any aspect of the blood transfusion
service – from collection to transfusion, auditing to licensing –
MUST be responsible for the quality of his/her work.
6. All BBs/BCs, BSF should mutually support and assist each
other to attain and maintain these standards.
7. All BBs/BCs and all other BSF should endeavor to gain and
sustain the public confidence, support and commitment through
consistent high quality of its services and products.

QUALITY SYSTEM REQUIREMENTS:

A. Quality objectives, Policies & Guidelines

Organizational Objectives – good manufacturing practices,

quality services, and blood products & legal requirements.

Policies & Guidelines – series of related or tiered documents

describing the system in each BB/BC.

Administrative procedures – Quality System Manual that puts

together the policies, job delineation, task delegation and
coordination.

B. Organization & Personnel

C. SOP & Work Instructions

1. Format of SOPs for Test Methods
♦ Name of test method
♦ Principle of the test and its clinical application
♦ Specimen collection & processing
♦ QC
♦ Reagents, equipment & supplies
♦ Procedural protocol
♦ Expected or normal values
♦ Interpretation of results
♦ Sources of error & troubleshooting
♦ Lab. safety & waste disposal

D. QC, Quality Assessment & Audit

E. Personnel Safety
1. Routine Infection Control Measures
2. Spills & accidents
3. Adequate & Appropriate Protective & Cleaning Devices
4. Important Prohibitions
5. Training on Safety Procedures & Monitoring of
Compliance
6. Immunization of Staff

F. Quality Records

THE BLOOD PRODUCTS &

DERIVATIVES
BLOOD PRODUCTS:
A. Regularly provided:
1. Red Blood Cells (RBC)
2. Fresh Frozen Plasma (FFP)
3. Cryoprecipitate
4. Cryosupernate

B. Special Blood Products

1. Leococyte – reduced RBC by filtration
2. Washed RBC
3. Plasma Frantionation Products

LABELLING

Unique BSF and Donation Number _ attached to the

ffg. during collection:
- All blood bags (including satellite bags)
- The donor form
- All blood sample containers

Content of Labels
 The unique coded “BSF–donation” number
 Name & license No. of BB/BC which collected and
manufactured the product
 Identity & volume of the blood product.
 ABO group & Rh group
 Type & volume of anticoagulant
 Required storage temperature
 Date of collection &/or preparation/ manufacture
 Expiry date
 Date & time of release from the BSF.

Special or Additional Labels

These are usu. added to special products, such as:

1. Products to be used within 72 hours or less, with the
time & date of expiration.
2. “NOT FOR TRANSFUSION” or “FOR OTHER
SCIENTIFIC PURPOSES”
3. Products “FOR AUTOLOGOUS USE ONLY”
THE PHYSICAL PLANT, EQUIPMENT
& MATERIALS
A. BUILDINGS & FACILITIES
1. Building design and maintenance
2. Restriction of entry of unauthorized persons and
personnel
3. Construction materials and work surfaces
4. Clear demarcation and smooth flow of work and
activities
5. Adequacy of space
5.1. Donor Reception & Refreshment areas
5.2. Donor Assessment area
5.3. Hb determination area
5.4. Blood collection, testing & processing area
5.5. Areas for packaging, validation, labelling
and other finishing and documentation
operations
6. Storage
6.1. Blood products
6.2. Reagents & other supplies and materials
6.3. Records, SOP manuals and refernces
7. Lighting & ventilation
8. Safety & Cleanliness
8.1. Eating, Drinking & Smoking
8.2. Toilet & washing facilities and lockers for
Personnel
8.3. Doors & Fire exits
8.4. Daily Cleaning & arranging
8.5. Drains
8.6. Pest control
B. EQUIPMENT
1. Appropriate and adequate equipment
2. Quality of Equipment & instruments
3. Proper use of equipment
4. Maintenance and service
5. Calibration
6. Storage equipment
6.1. Clear demarcation of stored blood and
supplies:
Area 1: Fully screened blood products ready for
release or transfusion
Area 2: Blood products awaiting completion of
tests
Area 3: Blood products under quarantine awaiting
repetition of tests that initially gave questionable results
Area 4: Blood products under quarantine for
disposal or submission to the DOH
Area 5: Autologous blood, when applicable

7. Temperature monitoring & alarm system

8. Defrosting and cleaning
9. Sterilization Equipment
Sat. team (Autoclave)
Dry heat (oven)
 C. SUPPLIES AND MATERIALS
1. Appropriate & Adequate Glasswares, Reagents &
Supplies
2. Quality of Reagents & Materials
3. Defective blood bags & Poor quality reagents
4. Supplies other than Blood bags & reagents
5. Duty – free importation

THE DONOR
TARGET GROUPS FOR BLOOD DONATION:
1. AGE - persons 18 to 60 years old are accepted.
2. WEIGHT – For 450 ml donations, at least 110 lbs. (50
kg)
For 250 ml donations, at least 40 kg.
3. TEMPERATURE - oral temperature must not exceed
37.5ºC.
4. PULSE - must be regular between 50 to 100/minute
5. BLOOD PRESSURE - must be between 90 –160
mm Hg systolic & 60 - 100 mm Hg diastolic
6. HEMOGLOBIN - the level must not be less than 12.5
gm/dl (125 g/L)
Donor must be given clearance by the attending
Medical Officer.

PERMANENT DEFERMENT:
1. Cancer
2. Cardiac dses.
3. Severe lung diseases
4. Viral hepatitis or jaundice of unknown origin and other
sever liver dses. Like cirrhosis
5. Use of prohibited drugs (past or present)
6. High risk sexual behavior or continuing exposure to
persons with Hepa, HIV/ AIDS & other STDs including
inmates of mental institutions & prisons.
7. High risk occupation
8. STDs (past or present)
9. Prolonged bleeding
10. Unexplained weight loss of more than 5 kg over 6
months.
11. Chronic alcoholism

DONOR TEMPORARY DEFERMENT

CONDITION DURATION OF DEFERMENT
1. Pregnant women 9 months after childbirth or 3 months after
weaning.
2. Acute febrile illness 2 – 3 weeks after febrile episode

3. Previous donation Interval from previous donation of 250 ml and

4. Major operation(including dental
surgery) or Blood Transfusion
(including transfusion of
450 ml from 6 – 8 weeks and 3 months or
longer respectively.
12 months after operation or transfusion.
Immunoglobulins)
5. Skin lesions at venipuncture site Until after skin lesions have completely healed.

6. Past exposure to unhygienic skin 1 year after incident

piercing, tattooing, earholing,
needle puncture, etc.
7. Past exposure to sexual partner or
close household contact with HIV/ 1 year after exposure
AIDS or Hepatitis

8. All persons who have been diagnosed 3 years after the cessation of signs & symptoms
or treated for Malaria or treatment for Malaria

9. Recent alcohol intake 12 hours after the last alcohol intake

DEFERMENT PERIOD OF BLOOD DONATION FFG. VACCINATION

Live, attenuated vaccines:
Category 1: Measles, Oral polio, 2 weeks after vaccination
Mumps, & yellow fever
Vaccines; BCG
Category 2: German measles 1 month after vaccination
(rubella) vaccine
Category 3: Rabies vaccination 1 year after vaccination

Killed vaccines and toxoids:

(DPT & DT, Injectable polio vaccine, May donate anytime if without vaccine –
Hepa B, Cholera, Typhoid, associated symptoms like fever.
paratyphoid, typhus, & Influenza
vaccines, among others)

DEFERMENT OF DONATION WHEN MEDICATIONS ARE BEING TAKEN

Antibiotics other than anti – TB drugs If medical condition is not severe, donor may
donate anytime
Anti – TB drugs Deferred until TB is completely healed.
Aspirin & piroxicam Anytime, provided that blood collected is not used
to prepare platelets.
Highly allergenic drugs like penicillin, May donate only after medications are stopped for
aspirin, others at least one day.
Contraceptive pills, depoprovera Anytime
Other drugs for symptomatomic Generally, anytime
treatment
Anti – Acne medications (Retinoids, 2 months after cessation of treatment
retinoic acid)

THE PRE –DONATION PROCESS

1. Pre –donation Interview, Education & Counselling

2. Donor screening
2.1. Donor Interview & PE
2.2. Hb determination, ABO grouping & Rh
typing
* Methods & Procedures
3. Donor & Medical Declaration Forms
4. Issuance of Blood Donation Number
 THE POST – DONATION PROCESS
1. Post – Donation Counseling
1.1. Donors with (+) results
1.2. Donors with (-) results
2. Repeat Donations
3. Donor Recruitment & Donor Incentive Schemes
4. Promotional Advocacy in Schools & Communities
5. Mass Bloodletting

 BLOOD COLLECTION, TETSING, PROCESSING,

STORAGE RELEASE & DISPATCH

THE RECIPIENT
Blood transfusion is given only when it is
ABSOLUTELY necessary.

Clinical Indications for Specific Blood Products:

1. WB – given only to actively bleeding patients who
are in hypovolemic shocks
2. RBC – severe anemia not corrected by Vit. or
mineral supplements
3. Specific components:
 Platelets or coagulation factors – bleeding
conditions due to specific deficiencies
 FFP, Cryoppt, Cryosupernate – when specific
CF are not available.

Massive Blood Transfusion

- complete volume replacement within less than 24 hours
in an adult, this is about 8 to 10 or more blood units or
components.

COMPATIBILITY OF DONOR WITH RECIPIENT BLOOD

Selection of Donor Blood according to ABO Group:

Patient’s Blood Donor’s Blood Donor’s Blood Type Donor’s Blood

Type Type 2nd Choice Type
1st Choice 3rd Choice
A+ A+ A- O+, O-
A- A- none O+, O-, A+
O+ O+ O- none
O- O- none O+
B+ B+ B- O+, O-
B- B- none O+, O-, B+
AB+ AB+ AB-,[A+, B+, A-, B-] O+, O-
AB- AB- [A-, B-] O+, O-
 BLOOD TRANSFUSION REACTIONS AND
COMPLICATIONS
Management of Common Blood Transfusion Reactions &
Complications:
1. Circulatory overload
2. Cellular or plasma incompatibilities
3. Transmission of infections
4. Anethesia may mask symptoms.
5. Acute hemolysis
6. Fever
7. Allergic reactions
8. Septicemia from infected blood
9. Jaundice
10. unexplained fall in Hb
11. Hepatitis
12. Hemoglobinuria
13. HIV

INVESTIGATION OF BLOOD TRANSFUSION

REACTIONS
1. Stop the blood transfusion and notify the hospital ward
MD and BB personnel immediately.
2. The ID of the patient and the name on the compatibility
label should be checked. Serious transfusion rxns are
usually due to ABO incompatibility and are almost
always a result of clerical error.
3. After the necessary clinical & records evaluation, the
remains of the unit, together with the attached
tranfusion set should be sent to the lab. for serological
testing and microbial assessment.
4. 5 – 10 ml clotted patient’s blood should be sent to the
lab., together with a post – transfusion sample of urine.
Blood samples for biochemical assays and Coagulation
tests will be needed if there is a major reaction.
5. A completed Transfusion reaction Form should
accompany the samples.
6. The blood transfusion lab. should recheck the donor
and recipient blood groups and repeat the crossmatch.
The pre –transfusion sample should be screened for
antibodies and a DAT should be done on the post –
transfusion sample.
Testing of the patient’s post –transfusion plasma and
urine for free Hb and hemosiderin should also be done
to detect serious hemolytic transfusion reactions.
7. When necessary, refer the samples to the designated
Reference Lab. for antibody detection & ID.

EMERGENCY RELEASE OF UNCROSSMATCHED OR

PARTIALLY CROSSMATCHED BLOOD
1. Blood samples must be taken from the recipient before
any blood is administered.
2. ABO grouping and Rh typing when indicated, shall be
performed.
3. An Emergency Release Form which must be signed by
the MD who ordered the transfusion must be
completed.
 4. The BB/BC must issue properly labelled blood and
must complete typing and compatibility testing as soon
as possible.
5. If Group O blood must be transfused to a patient with
unknown blood type, Group O RBC should be used and
blood should be switched to the recipient’s own type as
soon as possible.

WASTE MANAGEMENT
Classification of generated waste from the BSF:

I. HAZARDOUS WASTE – solid or combination of solid

waste which because of its quantity, concentration,
physical, chemical or infectious characteristics may
pose a substantial or potential threat to human health
or to the environment when improperly managed.
HAZARDOUS Description Treatment Waste Containers/
WASTES Packaging
Disposable equipment, Incineration, sanitary Yellow
INFECTIOUS utensils & articles or landfill or burying in an
WASTE substances that have been adequately secured lot
used or have contact with within premises.
blood and/or other body
fluids w/c may harbor or
transmit pathogenic
organisms.
SHARPS Needles, syringes, Buried within the BSF Contained in
scalpels, lancets, blades, compound on an properly –
broken glass, any item adequately secured and labelled puncture
made from of hard plastic identified lot intended for (RED)
or other material that can the purpose.
cause a cut or puncture. Incinerated and the
incombustible materials
buried
Sanitary landfilling after
waste have been cut into
pieces or shredded or
pulverized.
PATHOLOGICAL Consists of blood Chemically disinfected or
WASTE samples, blood clots, and autoclave prior to YELLOW
serum specimen. incineration
 Sodium hypochlorite
solutions (o.1 – 0.5%
Cl)
 70% Ethyl alcohol
 Isopropyl alc.
 2.5% Polyvidone
Iodine
 4% Formalin
 2% Glutaraldehyde
 6% H2O2

CHEMICAL Substance or solution Toxic chemical waste : Yellow with black

WASTE that is flammable, Incineration or autoclave, band.
reactive, toxic, corrosive, then proper disposal.
irritating or strongly
 sensitizing.

NON- Substance which is not 1. Use of sanitary Wet: Green

HAZARDOUS known to cause landfills
WASTE substantial potential 2. composting of Dry: Black
hazard to human health biodegradable waste
or the environment. material
(paper, other office 3. recycling scheme
supplies, food & other (factory returnables,
kitchen waste) fermentables,
fertilizers, etc.)
4. where a municipal or
city collection system
of disposal is available
5. use of improvised
incinerator or on – site
and closed burning
vault with anti –
pollution device.

QUALITY RECORDS

RESEARCH

Prepared by:

Eloisa D. Quizon, R.M.T.