XX Standards for Blood Banks and Transfusion Services
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
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.
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.
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.
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.
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 ³80 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: ³60% 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 ³80% 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 ³6.2.
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 37°C.
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 (³blood 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 10°C or cooled below 1°C
· 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 ³11 g/dL; Hct ³33%
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
|Plateletpheresis||if >q 4 weeks, plt count shall be ³150,000/uL|
|Whole Blood||Collected in anticoagulant. Can't be used as source of plts or coag||1-6°C/1-10°C||ACD/CPD/CP2D: 21 days
CPDA-1: 35 days
|Whole Blood Irradiated||1-6°C/1-10°C||Expiration or 28 days from irradiation, whichever is sooner|
|Red Blood Cells||1-6°C/1-10°C||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)||1-6°C/1-10°C||24 hrs after thaw|
|RBC Frozen||40% Glycerol £ -65°C|
20% Glycerol £ -120°C
|RBC Irradiated||1-6°C/1-10°C||Expiration or 28 days from irradiation, whichever is sooner|
|RBC Leukocyte Reduced||Contains 85% red cells, <5 x 10^6 WBC||1-6°C/1-10°C||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||1-6°C/1-10°C||24 hrs|
|RBC Washed||1-6°C/1-10°C||24 hrs|
|Platelets||20-24 C with continuous gentle agitation||24 hrs (w/o agit) - 5 days (depends on collection system)|
|or Plt Pheresis||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||£ -18°C||12 months thaw at 1-6°C, 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||£ -18°C or £ -65°C||£ -18°C: 12 months
£ -65°C: 7 years
|FFP thawed||1-6°C/1-10°C||24 hrs, Thaw at 30-37°C|
· ³17 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
· ³2 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 £ 37.5°C (99.5°F) orally
· Hb ³ 12.5 g/dL; Hct ³38%
· 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
· ³ 6 weeks after pregnancy unless for own infant, then approval by physician and medical director.
|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|
|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|
|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|
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.
|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|
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
Facilities and Safetey: ensure the provision of safe and adequate environmental conditions
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
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.
|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.|
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.
· ¯ Febrile reactions
· ¯ CMV transmission
· ¯ Immunosuppressive effects
· ¯ Alloimmune reactions to platelet antigens
· 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|
|Infectious mononucleosis (EBV)||anti-i|
|Plasmodium vivax malaria||Duffy|
1 or ‘ = C
2 or ” = E
Z or Y = CE
f = ce on same gene
g = CD on same gene
Warm Autoimmune Hemolytic Anemia
|Clinical: Most common autoimmune hemolytic anemia. Associated with B cell lymphomas, CLL, SLE, autoimmune diseases and other malignancies. Splenimegaly from hemolysis or lymphoproliferative disorder.|
|Pathophysiology: IgG Abs bind at 37 C|