Blood Bank Study Guide 2
Function of chemicals in preservatives added to units of RBCs
1. Citrate → chelates Ca++ to prevent clotting
2. MSP → maintains pH (buffer)
3. Dextrose → substrate for ATP synthesis
4. Adenine → nucleotide substrate for ATP synthesis
a. CPDA only one with Adenine → that's why it lasts the longest (42 days)
RBC storage lesion effects
Storage legion → in-vitro storage of RBCs can cause deterioration of the product’s
quality over time
● Decreased:
a. Viable RBC %
b. Glucose
c. ATP
d. pH
e. 2-3 DPG
● Increased:
a. Lactic acid
b. Potassium
c. Free HgB
d. Oxygen dissociation curve
The role of the FDA in blood banking (i.e., the FD&C, facilities requiring FDA
registration, how it enforces regulations, safety measures, etc.)
● FDA → drugs, biologics, devices, and instruments
○ CBER → regulates safety and efficacy of drugs, devices, blood
components, etc.
○ FD&C (Food, Drug, and Cosmetics Act of 1938) → has various Codes of
Federal Regulation (CFR) that hold blood products accountable via
cGMPs
i. cGMPs (current good manufacturing practices) → minimum
current practice for methods and facilities used to manufacture
a drug to ensure that it is safe, pure, and potent
○ 5 FDA layers of safety:
, i. Donor screening
ii. Donor blood testing
iii. Donor deferral records
iv. Quarantine
v. Recall, lookback, and RCA processes for problems
○ FDA enforcements → 3 series process
i. Warning letters
ii. Suspension
iii. Seizure
○ Facilities that are required to be registered with the FDA
i. Hospital BBs (us)
ii. Community BBs
iii. Component preparation facilities
iv. Storage and distribution centers
v. Carrier/transporters are NOT
○ All adverse and non-conforming events must be reported to the FDA
i. Most are due to donor questionnaire
ii. Fatality reporting:
● ASAP (< 7 days)
● Most instances involve TACOs and TRALIs
Allogeneic donations vs. autologous donations
● Autologous → donating to self, often for rare blood types or surgeries
a. ABO/RH testing only
i. No minimum age requirement
ii. Must be labeled autologous
iii. NOT able to enter allogenic blood supply if not used for
procedure
iv. Less strict (11 g/dL, 33%)
v. Collected 5-6 weeks before/during surgery
1. Inoperative Autologous Collection → collected during
the surgery, passed with a machine, washed, and put back
into patient
2. Postoperative Autologous Blood Salvage → blood is
collected from a drainage tube that is inserted into the
Function of chemicals in preservatives added to units of RBCs
1. Citrate → chelates Ca++ to prevent clotting
2. MSP → maintains pH (buffer)
3. Dextrose → substrate for ATP synthesis
4. Adenine → nucleotide substrate for ATP synthesis
a. CPDA only one with Adenine → that's why it lasts the longest (42 days)
RBC storage lesion effects
Storage legion → in-vitro storage of RBCs can cause deterioration of the product’s
quality over time
● Decreased:
a. Viable RBC %
b. Glucose
c. ATP
d. pH
e. 2-3 DPG
● Increased:
a. Lactic acid
b. Potassium
c. Free HgB
d. Oxygen dissociation curve
The role of the FDA in blood banking (i.e., the FD&C, facilities requiring FDA
registration, how it enforces regulations, safety measures, etc.)
● FDA → drugs, biologics, devices, and instruments
○ CBER → regulates safety and efficacy of drugs, devices, blood
components, etc.
○ FD&C (Food, Drug, and Cosmetics Act of 1938) → has various Codes of
Federal Regulation (CFR) that hold blood products accountable via
cGMPs
i. cGMPs (current good manufacturing practices) → minimum
current practice for methods and facilities used to manufacture
a drug to ensure that it is safe, pure, and potent
○ 5 FDA layers of safety:
, i. Donor screening
ii. Donor blood testing
iii. Donor deferral records
iv. Quarantine
v. Recall, lookback, and RCA processes for problems
○ FDA enforcements → 3 series process
i. Warning letters
ii. Suspension
iii. Seizure
○ Facilities that are required to be registered with the FDA
i. Hospital BBs (us)
ii. Community BBs
iii. Component preparation facilities
iv. Storage and distribution centers
v. Carrier/transporters are NOT
○ All adverse and non-conforming events must be reported to the FDA
i. Most are due to donor questionnaire
ii. Fatality reporting:
● ASAP (< 7 days)
● Most instances involve TACOs and TRALIs
Allogeneic donations vs. autologous donations
● Autologous → donating to self, often for rare blood types or surgeries
a. ABO/RH testing only
i. No minimum age requirement
ii. Must be labeled autologous
iii. NOT able to enter allogenic blood supply if not used for
procedure
iv. Less strict (11 g/dL, 33%)
v. Collected 5-6 weeks before/during surgery
1. Inoperative Autologous Collection → collected during
the surgery, passed with a machine, washed, and put back
into patient
2. Postoperative Autologous Blood Salvage → blood is
collected from a drainage tube that is inserted into the
