BLOOD BANKING

MEDICAL TECHNOLOGY LAWS AND BIOETHICS 2019 - 2020

BLOOD BANKING LAWS

ANSWERS TO FAQS:
FREQUENTLY ASKED QUESTIONS ANSWERS

1. What happens to my donated Will be examined for 5 TTIs: HIV, Malaria,

blood? Syphilis, Hepatitis B, Hepatitis C before
transfusion

2. Is it safe to give blood? YES

3. When can we donate blood? Every three months for a healthy person

4. Where can I donate blood? PRC’s National and Regional Blood

Center, or any Blood Services Facilities
nationwide

5. Can a person who has a tattoo YES, but a year after the procedure was
donate blood? one as well as other procedures involving
needles

6. Are the health history questions YES

necessary every time I donate?

7. What does the term “donor Individuals that are disqualified to donate
deferral” mean? blood

 There are three types of deferral

o Temporary- certain period of
time
o Permanent- disqualified
permanently/ lifetime
o Indefinite- no specific period
of time
8. If I was deferred once before, am I IT DEPENDS
still ineligible to donate?

9. What are some of the reason for  Hepatitis B or C infection

permanent deferral?  HIV infection
 Sexual contact with HIV person
 Multiple sexual partners/ patronizing
sex workers
 Serious chronic illness (heart and
lung diseases)
 BLOOD BANKING
ANSWERS TO FAQS:
10. Can a person who just had his/her Temporary deferred for a year
tooth extracted donate blood?

11. If I just received a flu shot, can I YES

donate blood?

12. If I have a cold flu, can I donate NO, a donor must be in good health
blood?

13. Can I still donate if I have high YES, if your bp is under control and within
blood pressure? the limits

14. What if I’m taking aspirin or Must not take aspirin or aspirin products 36
medication prescribed by any hours prior the donation
doctor? *aspirin inhibits platelet function*

15. What if I have anemia? NO

16. How long does it take to donate The process will only take an average of
blood? 25 mins

17. Will I put on weight after blood NO CHANGE OF BODY MASS

donation?

18. What other types of test are done ABO and Rh typing
on the blood?

19. What is the most common blood IN THE PHILIPPINES:

type? 1. “O+”
2. “B+”
3. “A+”
4. “AB+”
5. Rh negative groups
20. What fees are associated with Donated blood is FREE but the processing
blood? of the blood as well as quality assurance
are inclusive of the processing fee

21. What can you do if you aren’t  Recruit a suitable donor

eligible to donate?  Be a volunteer

22. How can I host a mobile blood Refer to the Blood Services Facility near
donation activity at work, school, you in order to learn more about the
church or community? requirements
 BLOOD BANKING
DEFINITION OF TERMINOLOGIES:
TERMINOLOGY DEFINITION

Voluntary non-remunerated donors These are individuals of sound mind and freewill
donating their blood without any material
consideration.

Donors selection criteria Are set of requirements and conditions an individual

should fulfill to be eligible for blood donation.

Deferral It is the process of classifying a donor as unqualified

either temporarily or permanently for blood donation.

Confidential Unit Exclusion(CUE) “Self-Deferral”

MOTIVATION FOR DONATIONS

o Desire to be HIV tested
o Peer pressure
o Receipt of a gift or time-off from work

CONFIDENTIAL UNIT EXCLUSION (CUE)

~ The donors must be given the confidential opportunity to inform blood collection facility
not to use their blood for transfusion.
~ Donor should be informed that their blood will be tested and they will be notified of
abnormal results.
~ “Self-deferral” opportunity may be given to donor upon completion of history and
physical examination, and prior to going into the donor room.

THREATS TO BLOOD SAFETY

o New diseases: recognizing transmission by blood
o Availability of screening/ confirmatory tests
o Formulating policy: standardization
o Test limitations/ test interferences
o Donor selection and product recall
 BLOOD BANKING
LIST OF SCREENING METHODS:
1. EIA Enzyme Immunoassay

2. ELISA Enzyme Linked Immunosorbent assay

3. CLIA Chemiluminescence Immunoassay

4. ECLIA Electrochemiluminescence Immunoassay

5. NAT / NAAT Nucleic Acid Amplification Test

LIST OF SPECIFIC REASONS FOR DEFERRAL

o Underweight
o Low hemoglobin
o Hypotension or uncontrolled hypertension
o Alcohol intake less than 12 hours prior to donation
o Cough/colds/ any form of infection
o Ear piercing/ tattoo/ body piercings = 12 months deferral
o Abnormal pulse rates (Tachycardia, Bradycardia or Arrhythmia)
o Recent vaccinations with live attenuated vaccines
- Mumps, Rubeola and, Oral Polio Vaccine = 2 weeks deferral
- German measles and, Rubella = 4 weeks deferral
- Killed, synthetic and inactivate vaccines like Hepatitis B and Salk = no deferral unless
there are symptoms like fever.
o Under quarantine(recent travel abroad)
o Drug and substance abuse
o History of sexually transmitted infection
o Paid donors

 Regular voluntary or non-remunerated donors are safer than:

× Family replacement donors
× Paid donors
× Compulsory/coerced donors

STRATEGIES TO ENSURE BLOOD SAFETY

o Purely voluntary non-remunerated blood donors
o Meticulous donor interview
o Highly sensitive laboratory screening tests for TTI’s
o Confidential Unit Exclusion (CUE) or self-deferral
 BLOOD BANKING
STRATEGIES TO REDUCE RISK OF TTIs:
 Traceability, hemovigilance system
Hemovigilance System – it is the documentation of the whole transfusion chain starting
from donor screening until blood transfusion.
 Indication for transfusion
 Storage, pathogen and inactivation
 Screening tests
 Processing, quality control
 Donor eligibility

STRATEGIES TO INCREASE DONOR ACCEPTANCE RATES

o Minimizing donor reactions (e.g. fainting)
o Prevention/Management of iron-deficiency anemia
o Increasing accuracy of hemoglobin measurement

DONOR SELECTION CRITERIA:

DONOR SELECTION REQUIREMENTS

The donor shall appear in good health and

1. General Appearance free from visible lesions of the skin, mouth
and conjunctivae

Not necessary requirements for the quality

2. Fasting
of blood
AVOID FATTY FOOD PRIOR TO DONATION

3. Temperature Normal: 37C – 37.5C

Female: 12.5 g/dL
4. Hemoglobin
Male: 13.5 g/dL

5. Pulse Normal pulse rate: 60 -120 bpm

Regular Athletes: 40/50 – 120 bpm

Normal: 18-60 years old

6. Age Below: 15-17 years old should present a
consent their legal guardian

Diastolic: ≤100
7. Blood Pressure
Systolic: ≤180

The donor can donate blood 6 weeks after

8. Pregnancy
giving birth
 BLOOD BANKING
9. Dental Surgery 1 year after the surgery
Deferral for 1 year if there is a history of
10. Receipt of blood products
having received blood products
11. Viral Hepatitis Positive: Permanently Deferred

12. Other contagious diseases Positive: Temporary Deferral

Donors with severe allergic reaction shall
13. Allergy
be excluded
 Donors weighing 130 (60kg) or
more may donate maximum
450mL of blood.
 The physician will determine the
14. Weight amount of blood for donors
weighing between 110 (50kg) and
130 (60kg)

Normal weight: atleast 50kg

Calculations for Drawing Blood from Donors Weighing Less than 50kg:
Donor ′ s weight (kg)
A. Volume of blood needed × 450mL
50
Blood needed
B. Amount of anticoagulant × 14
needed 100

C. Amount of anticoagulant to be 63mL − Anticoagulant needed

removed from collection bag
A.
40kg
× 450mL = 360mL blood
50

B.
360 ml blood
× 14 = 50.4mL
100

C.
63mL − 50.4 = 12.6mL
 BLOOD BANKING

CODE OF ETHICS FOR BLOOD DONATION

AND TRANSFUSION
 OBJECTIVE: To define the ethical principles and rules to be observed in the field of
transfusion medicine
The code has been elaborated with the technical support and adopted by the WHO
~ JULY 12, 2000 - Adopted by the General Assembly of ISBT
~ SEPTEMBER 5, 2006 - Amended by the General Assembly of ISBT
Blood Centers: Donors and Donation
1. Blood donation including hematopoietic 2. A non-profit motive should not be the
tissues for transplantation shall, in all basis for the establishment and running
circumstances, be voluntary and non- of a blood service.
remunerated; no coercion be brought to
bear upon the donor.

A donation is considered as voluntary

and non-remunerated if the person gives
blood, plasma or cellular components of
his/her own free will.

The donor should provide informed

consent to the donation of blood or
blood components and to the
subsequent (legitimate) use of the blood
by the transfusion services.
3. The donor should be advised by the risks 4. Anonymity between donor and recipient
connected with the procedure; the must be ensured and the confidentiality
donor’s health and safety must be of donor information assured.
protected.

Any procedures relating to the

administration to a donor of any
substance should be in compliance with
internationally accepted standards.
5. The donor should understand the risks to
others of donating infected blood and
his or her ethical responsibility to the
recipient.
7. Blood must be collected under the
overall responsibility of a suitably
qualified, registered medical
practitioner.
9. Donors and recipients should be
informed if they have been harmed.
11. Wastage should be avoided in order to safeguard the interests of all potential recipients
and donor.
6. Blood donation must be based on
regularly reviewed medical selection
criteria and not entail discrimination of
any kind.
8. All matters related to whole blood
donation and haemapheresis should be
in compliance with appropriately
defined and internationally accepted
standards.
10. Blood is public resource and access
should not be restricted.
 BLOOD BANKING
Hospitals: Patients
1. Patients should be informed of the known 2. In the event that the patients are unable
risk and benefits of blood transfusion to give prior informed consent, the basis
and/or alternative therapies and have for treatment by transfusion must be in in
the right to accept or refuse the the best interest of the patient.
procedure. Any valid advance directive
should be respected.
3. Transfusion therapy must be given under 4. Genuine clinical need should be the
the overall responsibility of a registered only basis for transfusion therapy
medical practitioner
5. There should be no financial incentive to 6. As far as possible the patients should
prescribe a blood transfusion. receive only those particular
components that are clinically
appropriate and afford optimal safety
7. Blood transfusion practices established by national or international health bodies and other
agencies competent and authorized to do so should be in compliance with this code of
ethics.

BLOOD DONATION:
Whole Blood Donate every 3 months

Plateletpheresis Single plateletpheresis

- Donor can donate every 2 days in a 7 day
period
Double / Triple plateletpheresis
- Donor can donate once every 7 days
provided that there should not be more than 24
times in a year
Autologous blood o White Blood every 3 days
Autologous blood transfusion “self-donation” o Up to 3 days prior to surgery
- is the collection of blood from a single o Hct > 33%
patient and retransfusion back to the same
patient when required.
- done when you have TTIs/rare blood group

COMPATIBILITY TESTING (CROSS MATCHING)

 Donor’s RBC are tested with recipient’s serum
 Used to detect unexpected recipient antibodies
 Checks if transfusion is compatible

MAJOR CROSSMATCHING: DERS

Donor’s Erythrocyte and Recipient’s Serum
MINOR CROSSMATCHING: REDS
Recipient’s Erythrocyte and Donor’s Serum
 BLOOD BANKING
BLOOD USED ON EMERGENCY CASES:
~ Emergency case: a patient is bleeding out and the blood type is unknown
~ Group O, Rh Negative, uncrossmatched

BLOOD PRODUCTS
o Whole blood
o Red cell products
o Platelet products
o Granulocyte products
o Plasma derivatives
o Platelet rich plasma
o Fresh frozen plasma

Blood Product Indication for Use/ Storage Shelf-life Other Information

Purpose

Whole Blood Need for oxygen carrying 1–6C 21 / 35 / 42 450 mL of whole

capacity and volume days blood with 63 mL
replacement depending on of anticoagulant
Anticoagulant
For actively bleeding used 1-unit WB = Inc.
patients hct 3% and hgb
1g/dL

Packed Red Treatment of symptomatic 1–6C 35 – 42 days 200 – 250 mL of

Blood Cells anemia where oxygen depending on RBCs and 50 mL
carrying capacity is anticoagulant of plasma
needed
Hematocrit 55-
70% depending
on anticoagulant

1-unit RBCs = Inc.

hct 3% and hgb
1g/dL

Irradiated For immunocompromised 1–6C 28 days from

WBCs/RBCs individuals time of
irradiation OR
Inhibits T cell proliferation original expiry
date, WHICH
Prevent Transfusion
EVER COMES
Associated Graft vs. Host
FIRST
Disease (TA-GVHD)

Washed RBCs Prevent anaphylactic 1–6C 24 hours Effects of

reactions washing:
 BLOOD BANKING
-Free from
leukocytes and
platelets
-Reduced plasma
proteins
-15% RBC
reduction
Leukocyte Prevents repeated RBCs with 99.99%
Reduced RBCs nonhemolytic febrile of WBCs removed
transfusion reactions by Leukocyte
Reduction Filters
Reduces
immunosuppression of All cellular
recipient by donor WBC components are
leukoreduced
Frozen RBCs Used for: Glycerol is a
 Rare blood types -70 C in 10 years cryopreservative
 Autologous blood glycerol solution
for a postponed
operation Agitation must be
done to prevent
clumping
Platelet 20 – 24 C 3.0 x 1011 platelets
Concentrate Raises the platelet count with 5 days plus 300 mL of
constant plasma
see separate table agitation Donated by a
for more
information
single donor
Granulocyte For Neutrophil count of
Concentrate <500/uL 22 – 24 C 20 – 24 hours
Septicemia unresponsive
to antibiotics
Fresh Frozen Used in patients with 200 – 250 mL of
Plasma multiple coagulation plasma frozen at -
deficiencies: 18 C within 8
 Liver disease  -18 C = 1 year hours of
 Disseminated  -65 C = 7 years collection
Intravascular
Coagulation (DIC) No platelets are
present
NOT USED if non-bleeding
OR for volume Contains no
replacement coagulation
factors
Cryoprecipitate Can be used
for the 1–6C 1 year
replacement
of the
following:
 BLOOD BANKING
-vWF (von vWD (von A white
willebrand willebrand precipitate that
factor) deficiency) forms when FFP at
18 degrees C is
-Factor VIII Hemophilia thawed to 4
A degrees C

-Factor XIII Factor XIII Volume of 10 – 15

deficiency mL

-Fibrinogen dec. 30 minutes for

fibrinogen thawing and
pooling
-Head injury, Head
massive injury,
bleed, massive
trauma bleed,
trauma

PLATELET CONCENTRATE:
Random Donor Single Donor Platelets Pooled Platelets
Platelets

Preparation Prepared from Whole Apheresis Prepared from

Blood Random Donor
Platelets

Shelf Life 5 days 5 days 4 hours

Platelet Content 5.5 x 1010 > 3 x 1011 > 3 x 1011

Plasma Volume 40 – 70 mL 300 mL Varies

Indication Actively bleeding Patients unresponsive Actively bleeding

patients to Random Donor patients
platelets

Red Blood Cell Substitutes:

 Short half life in the vascular system.
 Hemoglobin solutions.
 Decreased renal function
 Fluorocarbon compounds.
 High inspired oxygen requirements
 BLOOD BANKING
ADVERSE EFFECTS OR REACTION OF BLOOD TRANSFUSION:
Acute Hemolytic transfusion Reaction
Non-Hemolytic Febrile Transfusion Reaction
(NHFTR)
Allergic (Urticarial) Transfusion Reaction
Anaphylactic Transfusion Reaction
Circulatory Overload
Transfusion Related Acute Leukocyte Lung
Injury (TRALI)
Sepsis from Bacterial Contamination:
SEPSIS - Bacterial infection of the blood
Platelets:
- Plateletpheresis 1:5000
- Poopled platelets 1:1000
RBC:
- Sepsis from RBC due to Yersinia, Enterics or Gram Positive organisms: 1 in 3,000,000
~ A clerical error (wrong specimen,
wrong patient).
~ 1 in 6000 to 25000 transfusions.
~ Back pain, chest pain, fever, red urine,
oliguria, shock, DIC, death in 1 in 4.
~ Stop the transfusion
~ 1:100
~ Recipient has WBC antibodies to
donor’s WBCs contained with RBCs
and plateletpheresis products
~ DAT is negative
~ Rise in temperature by 2F or 1C
~ 1:1000
~ Recipient has antibodies to the
donor’s plasma proteins
~ Urticaria, Itching, Flushing, Wheezing
~ If symptoms continue, STOP
~ 1:150,000
~ Anaphylactic – heightened immune
response due to re-exposure to
antigen
~ Bronchospasm – difficulty in breathing
~ Treat with Epinepherine/ Solu-Medrol
~ 1:10,000
~ When CVS’s ability to handle extra
workload is exceeded
~ Marginal cardiovascular status
~ Acute shortness of breath, hair failure,
edema Systolic BP increases 50 mm
~ Infuse slowly, not to exceed 4 hours
~ Split the unit of RBC and give only half
~ 1:10,000
~ Donor plasma contains WBC
antibodies that when transfused to the
recipient cause agglutination of
recipient’s WBCs in the pulmonary
capillary beds.
 BLOOD BANKING

T: -18 C ; -65 C
SL: 1YEAR ; 7 YEARS

THAWED IN WATER
T: 20-24 C BATH AT 37 C
SL: 5 DAYS T: -18 C
SL: 1YEAR
T: 1-6 C
T: ROOM TEMPERATURE
T: 1-6 C SL: 24 HOURS
SL: 6 HOURS (single)
SL: 35 DAYS
: 4 HOURS (pooled)
T: -70 C
OPEN SYSTEM: SL: 10 YEARS
T: 1-6 C
SL: 34 DAYS
(REDUCED TO 24
HOURS)

CLOSED SYSTEM:
T: 1-6 C
SL: 35 DAYS