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Clinical use:
To minimize risk to recipients, a blood sample of a deceased donor of tissues or cells is collected and tested for communicable disease. It is recognized the volume of blood, colloids and crystalloids infused prior to death may affect these test results and an algorithm is used to determine the acceptability of a blood sample for infectious marker testing.
PRELIMINARY QUESTIONS FOR DETERMINING IF A DONOR SPECIMEN IS ADEQUATE FOR INFECTIOUS DISEASE TESTING.
Question 1
Has the donor had a transfusion or infusion?
• If the answer is no, then test the blood specimen
• If the answer is yes, then ask question 2
Question 2
Is the donor more than twelve years old?
• If the answer is no, then ask question 2a
• If the answer is yes, then ask question 3
Question 2a
Is there a recent pre-transfusion/infusion blood specimen available for the donor who is twelve years of age or younger?
• If the answer is no, then apply the algorithm worksheet
• If the answer is yes, then test the pre-transfusion/infusion blood specimen that is available
Question 3
Is there a recent pre-transfusion/infusion blood specimen available for the donor who is more than twelve years of age?
• If the answer is yes, then test the pre-transfusion/infusion blood specimen
• If the answer is no, then ask Question 4
Question 4
Has blood loss occurred?
• If the answer is no, then test the blood specimen
• If the answer is yes, then ask Question 5
Question 5
Are any of the following conditions exceeded?
• 2000 mL of blood or colloid given to the donor within the past 48 hours;
• 2000 mL of crystalloids within the last hour; or
• 2000 mL total of any combination of blood and colloid within past 48 hours, and crystalloid in the past hour
• If the answer is no, then test the blood specimen
• If the answer is yes, then apply the algorithm worksheet
Algorithm (Worksheet).
Donor ID: _________________
Date of sampling: ________________
Time of sampling (00.00): ________________
Donor Weight (kg): _________________
Blood Volume (BV) = donor’s weight (kg) ÷ 0.015 = ____ ml
or (BV) = donor’s weight (kg) x 70 mL/kg = ____ mL
Plasma Volume (PV) = donor’s weight (kg) ÷ 0.025 = ____ mL
or (PV) = donor’s weight (kg) x 40 mL/kg = ____ mL
A. Total Volume of Blood transfused/48 hours *
A1. Volume of RBCs transfused/48 hours ____ mL
A2. Volume of Whole blood transfused/48 hours ____ mL
Total volume (A = A1 + A2) ____ mL
(Enter “zero” if not transfused).
B. Total Volume of Colloid infused/48 hours *
B1. Volume of Dextran ____ mL
B2. Volume of plasma ____ mL
B3. Volume of platelets ____ mL
B4. Volume of albumin ____ mL
B5. Volume of hetastarch ____mL
B6. Volume of other ____ mL
Total volume (B = B1 to B6) ____ mL
(Enter “zero” if not infused).
C. Total Volume of Crystalloid Infused/1 hour *
C1. Volume of saline ____ mL
C2. Volume of Dextrose in water ____ mL
C3. Volume of Ringer’s lactate ____ mL
C4. Volume of other ____ mL
Total volume (C = C1 to C4) ____ mL
(Enter “zero” if not infused).
Determination of Sample Acceptability for Infectious Disease Tests:
Calculate both D and E below.
D. Is the sum of B + C greater than PV? Yes or No.
E. Is the sum of A + B + C greater than BV? Yes or No.
The post-transfusion/infusion sample is acceptable for testing where the answer to both D and E are “No”,
The post-transfusion/infusion sample is not acceptable if the answer to either D or E is “Yes”,
(In the latter case use a pre-transfusion/infusion sample or reject the potential donor of human tissues/cells).
* before death or sample collection, whichever comes first.
References
1. Directive 2006/17/EC of 8th February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for donation, procurement and testing of human tissues and cells. Official Journal of the European Union, L38/40 09/02/2006.
2. Guidance for Industry: Eligibility determination for donors of human cells, tissues and cellular and tissue based products (HCT/Ps), FDA, Center for Biologics Evaluation and Research, August 2007.
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091345.pdf
3. Chopek, M.M., Protein and Biochemical Changes During Plasma Exchange. Therapeutic Hemapheresis: A Technical Workshop Presented by the Committee on Technical Workshops, American Association of Blood Banks 1980; 1980:13-52.
4. Hemodilution-an overview of current canadian practices, Cell and Tissue Banking, 2: 41-44.2001.