Blood Bank (BB)

XX Standards for Blood Banks and Transfusion Services

Key Revisions:

1. Organization: management must assess effectiveness of a quality system through scheduled management reviews.
2. Equipment: criteria for selecting and a program for monitoring
3. Suppliers: BB must participate in selection of suppliers
4. Process Control:
- Medical director (MD) must participate in development of informed consent process for recipients
- Look-back not required for HTLV
- Indefinately defers recipient of HIV vaccine
- Donors whose partners are infected with HBV or unspecified viral hepatitis are deferred (not all household members)
- Intranasal cocaine not deferred
5. Documents and records: Most records now retained for 10 years (not indefinitely)
6. HLA standards deleted

Introduction:
Standards written by the Blood Bank/Transfusion Service Standards Program Unit of the AABB.
"Shall" is used to indicate a single acceptable activity or method.
"Should" is advisory for accreditation.
Standards represent accepted performance requirements that may be exceeded in practice.

In the state of California, following review and approval by DHS, these Standards are incorporated by reference into state law: may result in a situation where a facility gets a variance from AABB, but variance is not recognized by the state of California.

Organization:
The Blood bank shall have:
a structure that clearly defines and documents the parties responsible for the provision of blood, components and services.
a defined executive management structure.
a medical director (MD): licensed physician qualified by training or experience

Resources: (previously Personnel)
Evaluations of continued competence shall be performed at specified intervals.
Personnel records maintained.

Equipment:
Shall have policies, processes or procedures to calibrate, maintain and monitor equipment to conform to these Standards.
Shall define the selection criteria for equipment.
Only FDA-cleared devices can be used.
Monitoring includes: - calibration and adjustment, - labeling to show calibration status, - assessment of conformance of blood components, tissue and services if equipment is found to be out of calibration.
Record refrigerators' or ambient temp at least every 4 hours.
Warm blood so as to not cause hemolysis.

Supplier and Customer Issues:
Shall have policies to evaluate the ability of providers of critical materials and services to meets agreed upon requirements consistently.
Incoming blood, components, tissue, derivatives and critical materials shall be inspected and tested as necessary before acceptance or use (label is complete).
Containers and reagents must meet FDA criteria.

Process Control:
Shall have policies that ensure quality of blood, components, tissue and services.
Shall have a process to develop or change existing policies.
Proficiency testing for each analyte tested by the facility.
A program of quality control.
Materials must be used in accordance with manufacturer's instructions.
Sterility maintained.
Identification and traceacility: identify individuals performing each step in collection, processing, testing and distribution.
Labeling must conform to United Staes Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using ISBT128 (Nov 1999)
Labeling process must include a second check to ensure ABO/Rh, expiration date and component labels.
Donor identification and link to existing donor records.
Unit identification: unique numeric/alphanumeric ID, No more than 2 unique ID#s shall be visible on a blood component container.
Recipient blood collection: recipient identified positively, blood sample has 2 unique identifiers and date collected, and the label attached to tube at recipient's side.
Mechanism to identify phlebotomist.
Access to storage areas and authorization to remove contents should be controlled.
Components inspected before shipment.
Donor informed consent requires specific consent for marrow registry, and that there are some crcumstances where donor disease testing can't be performed.
MD approval needed for exceptions to donation interval.
Unit subjected to infectious disease testing and donor notified of positive results.
Look Back: HCV and HIV; notify recipient's physician and recipient, if appropriate.
Report suspected cases of transfusion-transmitted diseases and investigate each report; components involved in incident shall be identified.
Donor care: private and confidential.
Donor's educated to risks of infectious disease transmission by blood trasndfusion and signs/symptoms of AIDS. Acknowledge in writing.

Standards that apply to allogeneic donors apply to apheresis donors.
Blood shall be collected into a sterile, closed system.
Apheresis: Only 0.9% NaCl shall be used as a red cell diluent. All of available red cells from the phlebotomy shall be returned to donor before collecting a second unit of blood, but no more than 2 hours after the phlebotomy.
Donor weight <80 kg: whole blood < 500 ml/one time or 1000ml/2 day period. Plasma <500 ml/2 days.
Donor weight 80 kg: whole blood < 600 ml/ one time or 1200ml/2 day period. Plasma <600 ml/2 days.
Individuals with hemochromatosis may elect to be allogeneic blood donors.

Leukocyte Reduction: < 5 x10^6 leukocytes in final component. Retain at least 85% of original red cells.
Irradiation: minimum 25 Gy (2500 cGy) delivered to midplane of canister; minimum 15 Gy at any point. Verify dose annualy for cesium-137, semiannually for cobalt-60, upon installation, major repairs or relocation.

RBC: Final Hct 80%. Frozen within 6 days of collection. Placed in freezer within 6 hrs of opening the system.
RBC Pheresis: 60% Hb/unit
RBC low volume: 300-404 ml. Labelled as such. No other components shall be made.
RBC Rejuvenated: prepared no later than 3 days after expiration.
Deglycerolized: yield 80% of the original red cells following the deglycerolization process.
Cryo Antihemophilic Factor: separate the cold insoluble portion of FFP, result in min 150 mg fibrinogen min 80 IU of Factor VIII.
Platelets: min 5.5 x 10^10 plts in at least 75% of units. pH is 6.2.
Platelet Pheresis: min 3.0 x 10^11 plts in at least 75% of units.
Leukocyte reduced platelets have < 8.3 x10^5 leukocytes in final component.
Leukocyte reduced pooled platelets have < 5 x10^6 leukocytes in final component.
Granulocyte Pheresis: 1.0 x 10^10 granulocytes in at least 75% of units.

Donors with a history of transfusion or pregnancy shall be tested for unexpected antibodies to red cell anitgens.
Allogeneic blood tested for: HBsAg, anti-HBc, anti-HCV, anti-HIV1, anti-HIV2, HIV-1-Ag, anti-HTLV-I, anti-HTLV-II, serologic test for syphilis.
Autologous Blood if transfused outside of collecting facility, test before shipping on at least the first unit shipped during each 30 day period.
Autologous blood's patient's physician shall be informed of any abnormal results.
Shall have process for quarantine and disposition of all prior collections when a repeat donor tests positive (repeatedly reactive).

Requests for blood or components must contain sufficient information to uniquely identify the recipient, including two independent identifiers.
Before transfusion, ABO groups of all units of Whole blood and components labelled Rh- shall be confirmed. Confirmation for weak D not required.
Need method to detect ABO and Rh discrepancies between the current donation and previous donations by the same donor. Compare to typing performed in last 12 months.
Testing clinically significant antibodies shall be done at 37C.
If patient has been transfused or pregnant in last 3 months: blood drawn 3 days before scheduled transfusion.

Plasma components shall be ABO compatible. Need a policy concerning components that contain significant amounts of incompatible ABO antibodies or unexpected red cell antibodies.
Granulocytes and Platelets have to be ABO compatible unless component contains <2 ml red cells.
Need policy regarding CMV, and Hemoglobin S.
Irradiated: donor relative, donor HLA compatible.
Need policy for compatibility testing within 24 hrs a pt who receives massive transfusion (blood volume).
Neonates need to be ABO typed, can use only anti-A and anti-B reagents.
If non-group O neonate is to receive non-group O RBC that are incompatible with mom's ABO, must test neonate's serum for anti-A and anti-B.

Final inspection of blood and components before issue,
Reissue: only if following conditions observed:
container closure has not been disturbed
RBC not warmed above 10C or cooled below 1C
One sealed segment remains integral, and number matches remaining sealed segments, then they can be reattached
Blood has been inspected

Urgent Requirements for Blood:
Unknown ABO type: receive group O red cells.
ABO known: receive group-specific or compatible

With the exception of 0.9% NaCl USP drugs or medications shall not be added to blood components unless:
approved by FDA
addition is safe

Granulocytes: filters shall not be used in the administration set.

Rh Immune Globulin:
within 72 hrs of delivery, abortion, amniocentesis or any other event that could cause fetomaternal hemorrhage.
Postpartum blood sample to detect fetomaternal hemorrhage.

Blood Donation Type Interval Other Comments
Autologous Donor Not within 72 hrs of surgery Hb 11 g/dL; Hct 33%
Defer for bacterial infection
Plasmapheresis No more than once/4 weeks ("infrequent" program), physical exam & testing in "frequent" program Donor weighs at least 50 kg (110 lb)
Cytapheresis at least 2 days, no more than 2x/week or 24x/year Intravascular volume deficit shall not exceed 10.5 mL/kg donor's weight
Whole Blood 8 weeks
Plateletpheresis if >q 4 weeks, plt count shall be 150,000/uL

 

Component Volume/Contains Temperature (Storage/Transport) Expiration
Whole Blood Collected in anticoagulant. Can't be used as source of plts or coag 1-6C/1-10C ACD/CPD/CP2D: 21 days
CPDA-1: 35 days
Whole Blood Irradiated 1-6C/1-10C Expiration or 28 days from irradiation, whichever is sooner
Red Blood Cells 1-6C/1-10C ACD/CPD/CP2D: 21 days
CPDA-1: 35 days
Additive Soln': 42 days
Opened: 24 hrs
RBC Deglycerolized Washed with successively lower concentrations of NaCl (USP) 1-6C/1-10C 24 hrs after thaw
RBC Frozen 40% Glycerol -65C
20% Glycerol -120C
10 years
RBC Irradiated 1-6C/1-10C Expiration or 28 days from irradiation, whichever is sooner
RBC Leukocyte Reduced Contains 85% red cells, <5 x 10^6 WBC 1-6C/1-10C ACD/CPD/CP2D: 21 days
CPDA-1: 35 days
Additive Soln': 42 days
RBC Rejuvenated or
Rejuv Deglycerolized
Added 2,3-DPG and ATP to normal levels 1-6C/1-10C 24 hrs
RBC Washed 1-6C/1-10C 24 hrs
Platelets
or Plt Pheresis
20-24 C with continuous gentle agitation 24 hrs (w/o agit) - 5 days (depends on collection system)
Pooled or Opened 4 hrs.
Plts Irradiated or Leukocyte Reduced 20-24 C with continuous gentle agitation No change
Granulocytes 20-24 C 24 hrs
Cryoppt AHF The cold, insoluble portion of plasma processed from FFP -18C 12 months
thaw at 1-6C, Refreeze within 1 hr
Cryo, Thawed 20-24 C Open system or pooled: 4 hrs
Single unit or pooled prior to freezing: 6 hr
FFP -18C or -65C -18C: 12 months
-65C: 7 years
FFP thawed 1-6C/1-10C 24 hrs, Thaw at 30-37C

Donor Qualifications:
17 years old or applicable state law
Maximum of 10.5 ml whole blood/kg donor weight
8 weeks after whole blood
16 weeks after 2 unit red cell collection
4 weeks after infrequent apheresis
2 days after plasma or platelet leukapheresis
BP 180 mm Hg systeolic, 100 mm Hg diastolic
HR 50-100 or 50 if an otherwise healthy athlete
Temp 37.5C (99.5F) orally
Hb 12.5 g/dL; Hct 38%
Drug Therapy:
- Finasteride (Proscar, Propecia), Isoretinoin (Accutane) - defer 1 month after last dse
- Acitretin (Soriatane) - defer 3 years
- Etretinate (Tegison) - defer indefinitely
- Aspirin - precludes use of donor as sole source of platelets
Free of major organ disease, cancer or abnormal bleeding
6 weeks after pregnancy unless for own infant, then approval by physician and medical director.

Category
Deferral
Family history of CJD Indefinitely
Receipt of dura mater or pituitary growth hormone or their derivatives Indefinitely
Receipt of blood, components, human tissue or clotting factor concent 12 months
Toxoids, synthetic or killed vaccines (e.g. HBV, Pertussis, Pneumococcus, Rabis without exposure, Tetanus, Anthrax, Cholera, Diptheria, HAV, Influenza, Lyme disease, Paratyphoid, Plague, injected Polio &Typhoid) None
Live, attenuated vaccines (Measles, Mumps, oral Polio & Typhoid, Yellow fvr) 2 weeks
Live, attenuated vaccines (Rubella, Varicella Zoster) 4 weeks
Other vaccines (HBIg, Rabies, unlicensed vaccines) 12 month
AIDS vaccine Indefinitely
History of viral hepatitis after 11th birthday Indefinitely
Confirmed positive test for HBsAg Indefinitely
Repeat reactive anti-HBc on more than one occasion Indefinitely
HCV, HTLV, HIV, Babesiosis, Chagas' Indefinitely
Stigmata of parenteral drug use or use of needle for nonprescription drugs Indefinitely
Tattoo 12 month
Mucous membrane or skin-penetration blood exposure 12 month
HBV sexual contact or residing in household 12 month
Sexual contact with person at high risk for HIV 12 month
Incarceration >72 hrs 12 month
Rx for syphilis or gonorrhea 12 month
Malaria (Dx or living in endemic country - plasma exempt) 3 years
Visiting endemic area for malaria 12 month
Living in England between years 1986-2001 for > 6 months Indefinitely

Records:
Need to be able to trace a unit of blood from its source to its final disposition.
Need a process to introduce to the computer system new hardware, software or databases. Risk analysis, training, validation.

Record Retention Time
Unique unit identification 10 years
Medical director approval for exceptions to donation 5 years
Donors placed on indefinite deferral Indefinite
Investigation of transfusion-transmitted disease 10 years
Donor's ABO & Rh type 5 years
Donor testing for unexplained antibodies 10 years
HCV or HIV look back 10 years
Recipient's ABO & Rh type 5 years
Patient's transfusion medical record (unit, date, vital signs) 10 years
Suspected transfusion complication 5 years
Archival of obsolete documents 5 years
Orders for tissue 10 years

Transfusion-Related Complications:
Shall have a process for detection, reporting, and evaluation of suspected complications.
Fatal donor or transfusion reactions shall be reported to FDA.
Circulatory overload or mild urticarial reactions need not be evaluated as possible hemolytic reactions.

Monitoring of Blood Utilization:
Peer review program
Process Improvement

Facilities and Safetey
: ensure the provision of safe and adequate environmental conditions

Glossary:
Competence: ability of an individual to perform a specific task according to procedures.
Compliance/Conformance: Fulfillment of requirements. May be defined by customers, practice standards, regulatory agencies or law.
Critical: capable of affecting quality
Error: unexpected or unplanned deviation from standard policy or procedure, usually attributable to a human or system problem.
Neonate: < 4 months of age
Resident: home for >12 continuous months.
Validation: establishing recorded evidence that provides a high degree of assurance that a specific process will consistently produce an outcome meeting its predetermined specifications and quality attributes.
Verification: evaluating the performance of a system with regard to its effectiveness based on intended use.

Notes from questions and tapes

Storage:
1. adenine increases storage life of RBC
2. -65C can be stored for 10 years
3. thawed/washed RBCs only good for 24 hrs
4. thawed cryo has to sit at RT: good for 6 hrs

Storage decreases glucose, pH, by day 5 factor 5 deteriorates, increase in K+,
drop in 2,3 DPG (O2 curve shifts to the left: oxygen released at low O2 tension only)

Irradiation decreases RBC shelf life to 3 weeks: damage to Na/K pump

How to evaluate bag for contamination: hemolysis (Clostridium), purple plasma (Pseudomonas), clots (citrate consuming organisms), air bubbles

Notes from Doug Blackall
Infectious Risk Associations:
HCV: 1 in 103,000
HBV: 1 in 63,000
HBV or HCV: 1 in 34,000
HIV: window period avg 8 weeks. 1:40,000 to 1:1,000,000 (NEJM 1:493,000)
HTLV: 1 in 641,000

Whole blood (500 ml) used to make one unit each of RBCs, plts, FFP. One unit of FFP used to make one unit cryo.

Unit Volume Contents Dose Indications/Contraindications
Red Blood Cells 250-300 ml RBC in reduced plasma, inactive WBCs and platelets 1 unit increases Hb by 1 gm/dL, Hct by 2-3% chronic, symptomatic anemia
actively bleeding patient (Hb < 7 gm/dL)
NOT if blood loss <20% blood volume - restoration can be done using crystalloids alone
FFP 200-250 ml All coagulation factors 4-6 units initially, further Rx guided by PT/PTT
Adults 15 ml/kg to start then check PT
Treat bleeding or prepare for invasive procedure or surgery in patients with:
multiple factor deficiencies (ESLD, DIC...)
isolated factor deficiency (2, 5, 7, 10, 11)
needing emergency reversal of coumadin
TTP, HUS, Protein C or S deficiency
NOT for prophylactic use in massive transfusion, volume expansion, nutritional support, bleeding with no factor deficiency, increased PT/PTT alone.
Platelet Concentrate 50-70 ml Platelets suspended in small volume of plasma. Few WBC/RBC as well. Pools of 6-8 units. Each unit should increase count by 5-10 x 10^9/L Measure plt count 10 minutes to 1 hour after transfusion. Prophylaxis if plts <15-20,000
Plts < 50,000 in actively bleeding patient
H/O plt dysfunction
NOT for prophylactic use in massive transfusion, plt dysfunction due to extrinsic factors (uremia, vWF def), TTP, HUS, or heparin-induced thrombocytopenia, ITP, post-transfusion purpura, DIC
Cryoprecipitate 15-20 ml Factor 8, 13, vWF, fibrinogen, fibronectin 80-120 units Factor 8, 200 mg fibrinogen, for hypofibrinogenemia dose 5-10 units initially
Plasma Volume = kg wt x 0.07 x (1-Hct)
Fibrinogen = PV x [fibrinogen]
Desired - Actual / 200 = # bags
Each bag increases fibrinogen by 5-10 mg/dL
t1/2 of Factor 8 is 12-18 hr; Factor 9 is 24-32 hr
von Willebrand's Disease
Hemophilia A
Congenital hypofibrinogenemia (levels <100) or dysfibrinogenemia.
Granulocytes 300 ml 1 x 10^10 PMNs/bag 1-2x/day for at least 4 consecutive days. Profound, reversible neutropenia (ANC <500)
Bacterial infxn/fever >24-48 hrs on Abx
BM myeloid hypoplasia
Reasonable chance of recovery
Rh(D) Immune Globulin 1 ml 300 mg IgG anti-D Use 300mg for each 30 ml fetal red blood cells or 15 ml of adult D+ blood..
Kleihauer-Betke Test: Hb F resistent to acid elution. % fetal cells x 50 = ml whole blood;
If 2.2 doses: give 3 (round up);
if >2.5 doses give 4 (round upand add 1);
need appropriate controls and adult hemoglobinopathies may create misleading picture. If pregnancy terminates before 13 weeks 50 mg dose used.
Prevention of hemolytic disease of the newborn due to Rh(D) antigen.

Transfusion Reactions:
Anaphylactic: due to IgA deficiency (1:700) with anti-IgA antibodies. Rare reported abs to drugs (PCN). Rx: dyglycerolized/washed RBC.
Post-Transfusion Purpura: PLA-1 antigen. Rx: IvIg (very effective), plasmapheresis, steroids.

Leukocyte-reduced RBCs:
Febrile reactions
CMV transmission
Immunosuppressive effects
Alloimmune reactions to platelet antigens

Irradiated Plts/RBC:
BMT
ChemoRx with hematologic malignancies (NHL, HD, Leukemia)
SCID, DiGeorges, Wiskott-Aldrich (NOT AIDS)
Intrauterine transfusion
Neonates < 1300 gms (controversial)
All first degree relatives (GVHD: lethal 90%)

After D antigen (Rh), the K antigen (Kell) is most immunogenic.
Enzymes enhance Rh epitopes by cleaving other proteins who overshadow or cover Rh epitopes. Decrease reactivity to Duffy, MNS.
DTT and 2-ME break the disulfide bonds of the J chain of the IgM molecule, but leave IgG molecule intact.
ZZAP reagent dissociates IgG.
Dolicus bifloris lectin - identifies A1.
Secretor (Se) gene is dominant.
Paroxysmal Cold Hemoglobinuria: Complement-fixing IgG Abs against P blood group determinants. (Donath-Landsteiner Abs.)
Anti-P can also cause severe hemolytic transfusion reactions and recurrent spontaneous abortions (placental tissue a rich source of P).
Cold autoimmune hemolytic anemia (cold agglutining disease): IgM anti-I
Kidd: frequent cause of delayed hemolytic Tx reactions. Job is urea transport: Jk(a-b-) red cells will not lyse in 2M urea.

Infectious Agent Blood Group Association/Ab
Mycoplasma pneumonia anti-I
Infectious mononucleosis (EBV) anti-i
Helicobacter pylori Lewis
Parvovirus B19 P
Plasmodium vivax malaria Duffy

Rh+
Rh-
R1
CDe
r'
Cde
R2
cDE
r"
cdE
Rz
CDE
ry
CdE
Ro
cDe
r
cde

1 or ' = C
2 or " = E
Z or Y = CE
f = ce on same gene
g = CD on same gene

Warm Autoimmune Hemolytic Anemia
Mnemonic:
AKA: WAIHA
Clinical: Most common autoimmune hemolytic anemia. Associated with B cell lymphomas, CLL, SLE, autoimmune diseases and other malignancies. Splenimegaly from hemolysis or lymphoproliferative disorder.
Transmission:
Pathophysiology: IgG Abs bind at 37 C
Diagnosis:
Gross:
Micro:
Stains:
IF:
EM:
Cytogenetics:
DDx:
Grading:
Staging:
Treatment:
Prognosis:

Images:

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