I. Blood Collection An overview of the process involved in collecting donor blood

Donor Screening Starts with the donor and first impressions are critical Starts with the donor and first impressions are critical Clean, well lit donation facility from waiting room to collection area Clean, well lit donation facility from waiting room to collection area Pleasant, professional staff who can ask the appropriate questions, observe and interpret the responses, and ensure that the collection process is as pleasant as possible Pleasant, professional staff who can ask the appropriate questions, observe and interpret the responses, and ensure that the collection process is as pleasant as possible

Blood Bank versus Blood Center Confusion exists and terms are sometimes used inappropriately Confusion exists and terms are sometimes used inappropriately Blood bank in a hospital is also known as the transfusion service, performs compatibility testing and prepares components for transfusion Blood bank in a hospital is also known as the transfusion service, performs compatibility testing and prepares components for transfusion Blood Center is the donation center, screens donors, draws donors, performs testing on the donor blood, and delivers appropriate components to the hospital blood bank Blood Center is the donation center, screens donors, draws donors, performs testing on the donor blood, and delivers appropriate components to the hospital blood bank

Standards, Regulations, Governing Bodies Strict guidelines exist and inspections are performed in both blood centers and blood banks to ensure the safety of the donors and patients Strict guidelines exist and inspections are performed in both blood centers and blood banks to ensure the safety of the donors and patients Some or all of the following agencies may be involved: Some or all of the following agencies may be involved: FDA – Food and Drug Administration – CBER and CFR FDA – Food and Drug Administration – CBER and CFR AABB – American Association of Blood Banks AABB – American Association of Blood Banks CAP – College of the American Pathologists CAP – College of the American Pathologists Joint Commission – inspects hospitals, lab included Joint Commission – inspects hospitals, lab included CLSI – Clinical Laboratory Standards Institute CLSI – Clinical Laboratory Standards Institute

Donor Screening Two goals of screening Two goals of screening Protect the health of the potential donor Protect the health of the potential donor Protect the health of the potential recipient Protect the health of the potential recipient Four outcomes Four outcomes Acceptance Acceptance Temporary deferral Temporary deferral Indefinite deferral Indefinite deferral Permanent deferral Permanent deferral Two components of screening Two components of screening Health history interview Health history interview Limited physical examination. Limited physical examination.

Donor Registration Donor signs in Donor signs in Written materials are given to the donor which explains high risk activities which may make the donor ineligible Written materials are given to the donor which explains high risk activities which may make the donor ineligible Donor must be informed and give consent that blood will be used for others unless they are in a special donor category Donor must be informed and give consent that blood will be used for others unless they are in a special donor category First time donors must provide proof of identification such as SS#, DL#, DOB, address and any other unique information. First time donors must provide proof of identification such as SS#, DL#, DOB, address and any other unique information. Repeat donors may be required to show DL or some other photo ID Repeat donors may be required to show DL or some other photo ID

Donor Registration Additional useful information Additional useful information Name of patient or group to credit Name of patient or group to credit Race Race Unique donor characteristics Unique donor characteristics Donor must be provided with Donor must be provided with HIV high risk activities HIV high risk activities Warnings about donor reactions Warnings about donor reactions Tests that will be performed and notification Tests that will be performed and notification Post phlebotomy care instructions Post phlebotomy care instructions

Medical History Frequency of donation Frequency of donation Whole blood or red blood cells 8 weeks Whole blood or red blood cells 8 weeks Plateletpheresis – up to 24 times/year Plateletpheresis – up to 24 times/year Plasmapheresis– once every 4 weeks, can be done twice a week Plasmapheresis– once every 4 weeks, can be done twice a week

Medical History A thorough history is obtained each time A thorough history is obtained each time Standardized universal questionnaire is used Standardized universal questionnaire is used Questions are asked that are very intimate in nature but are critical in assessing HIV or HBV risks Questions are asked that are very intimate in nature but are critical in assessing HIV or HBV risks Has donor ever been deferred, if yes, why. Has donor ever been deferred, if yes, why. Medications the donor taking are present in plasma, may cause deferral Medications the donor taking are present in plasma, may cause deferral Infections the donor has may be passed to recipient, may be cause for deferral Infections the donor has may be passed to recipient, may be cause for deferral

Permanent Deferrals Males who had sex with males OR engaged in sex for drugs or money since Males who had sex with males OR engaged in sex for drugs or money since Used IV drugs even ONCE in lifetime. Used IV drugs even ONCE in lifetime. Taking clotting factors. Taking clotting factors. Hepatitis PRIOR to age 11. Hepatitis PRIOR to age 11. Most cancers except minor skin cancer and carcinoma in-situ of the cervix. Most cancers except minor skin cancer and carcinoma in-situ of the cervix. Lived in a country where Creutzfeld-Jacob disease is prevalent or family member with CJD. Lived in a country where Creutzfeld-Jacob disease is prevalent or family member with CJD. Protozoan diseases such as Chagas disease or Babesiosis Protozoan diseases such as Chagas disease or Babesiosis Received human pituitary growth hormone. Received human pituitary growth hormone. Positive test for: HBsAg, Hepatitis C, HTLV I/II or HIV. Positive test for: HBsAg, Hepatitis C, HTLV I/II or HIV. Donated only unit of blood in which a recipient contracted HIV or HBV Donated only unit of blood in which a recipient contracted HIV or HBV Was the only common donor in 2 cases of post- transfusion HIV or HBV in recipient Was the only common donor in 2 cases of post- transfusion HIV or HBV in recipient

12 Month Deferral Recipient of blood, components or blood products such as coagulation factors Recipient of blood, components or blood products such as coagulation factors Sexually transmitted disease-if acquired indicates safe sex not practiced and donor at risk for HIV and HBV Sexually transmitted disease-if acquired indicates safe sex not practiced and donor at risk for HIV and HBV Received HBIG. Received HBIG. Accupuncture, tattoo, ear piercing Accupuncture, tattoo, ear piercing Needle stick Needle stick Rabies vaccine Rabies vaccine Any intimate sexual relations with HIV or HBV positive, hemophiliacs, drug users or individuals receiving drugs/money for sex. Any intimate sexual relations with HIV or HBV positive, hemophiliacs, drug users or individuals receiving drugs/money for sex.

Temporary Deferrals Certain immunizations Certain immunizations 2 weeks -MMR, yellow fever, oral polio, typhoid 2 weeks -MMR, yellow fever, oral polio, typhoid 4 weeks -Rubella, Chicken Pox 4 weeks -Rubella, Chicken Pox 2 months – small pox 2 months – small pox Pregnancy – 6 weeks upon conclusion Pregnancy – 6 weeks upon conclusion Certain medications Certain medications Proscar/Propecia, Accutain – 1 month Proscar/Propecia, Accutain – 1 month Avodart – 6 months Avodart – 6 months Soriatane – 3 years Soriatane – 3 years Tegison – permanent Tegison – permanent Malaria 3 years Malaria 3 years West Nile virus 28 days West Nile virus 28 days

Helpful Hint Permanent deferral – any member of high risk group such as: HIV/HBV/HCV pos, drugs/sex for money, cancer, serious illness or disease, CJD, Chagas disease, Babesiosis Permanent deferral – any member of high risk group such as: HIV/HBV/HCV pos, drugs/sex for money, cancer, serious illness or disease, CJD, Chagas disease, Babesiosis 12 month deferral – sex with any high risk group, any blood exposure, recipient of blood/blood products, STD, jail/prison, rabies vaccine after exposure, HBIG, malaria 12 month deferral – sex with any high risk group, any blood exposure, recipient of blood/blood products, STD, jail/prison, rabies vaccine after exposure, HBIG, malaria Have to memorize: medications and vaccinations Have to memorize: medications and vaccinations

Physical Examination Evaluate general appearance Evaluate general appearance Weight – 123 lbs. – NEW JAN 2010 Weight – 123 lbs. – NEW JAN 2010 Temperature 37.5 C OR 99.5F Temperature 37.5 C OR 99.5F Blood pressure Blood pressure Systolic </= to 180 mm Hg Systolic </= to 180 mm Hg Diastolic </= 100 mm Hg Diastolic </= 100 mm Hg Hemoglobin and Hematocrit Hemoglobin and Hematocrit Allogenic 12.5 g/dL or 38% Allogenic 12.5 g/dL or 38% Autologous 11.0 g/dL or 33% Autologous 11.0 g/dL or 33%

Self-Exclusion Two stickers Two stickers “Yes, use my blood” “Yes, use my blood” “No, do not use my blood” “No, do not use my blood” After interview the donor will place the appropriate bar coded label on the donation record After interview the donor will place the appropriate bar coded label on the donation record If “no” selected the unit is collected, fully tested, but not used for transfusion If “no” selected the unit is collected, fully tested, but not used for transfusion Allows donors who know they are at risk to “save face” if pressured to donate by friends and family Allows donors who know they are at risk to “save face” if pressured to donate by friends and family

Donor Categories “Allogeneic”, “homologous” and “random donor” terms used for blood donated by individuals for anyone’s use “Allogeneic”, “homologous” and “random donor” terms used for blood donated by individuals for anyone’s use Autologous – donate blood for your own use only Autologous – donate blood for your own use only Recipient Specific Directed donation – donor called in because blood/blood product is needed for a specific patient Recipient Specific Directed donation – donor called in because blood/blood product is needed for a specific patient Directed Donor – patient selects their own donors Directed Donor – patient selects their own donors Therapeutic bleeding – blood removed for medical purposes such as in polycythemia vera. NOT used for transfusion. Therapeutic bleeding – blood removed for medical purposes such as in polycythemia vera. NOT used for transfusion.

Auto/Directed Blood Labels

Donor Categories Apheresis – removal of 1 component, return the rest Apheresis – removal of 1 component, return the rest Leukapheresis Leukapheresis Plateletpheresis Plateletpheresis Plasmapheresis Plasmapheresis Stem cells Stem cells Bone marrow Bone marrow Apheresis Apheresis

Donor Categories Safest is autologous, blood is your own, no risk of disease acquisition Safest is autologous, blood is your own, no risk of disease acquisition Most dangerous is Directed Donor, you select a donor who may, unknown to you, be in a high risk category but feels obligated to follow through and donate Most dangerous is Directed Donor, you select a donor who may, unknown to you, be in a high risk category but feels obligated to follow through and donate

Blood Collection

Collection of Blood Materials used are sterile and single use. Materials used are sterile and single use. Most important step is preparing the site to a state of almost surgical cleanliness. Most important step is preparing the site to a state of almost surgical cleanliness. Bacteria on skin, if present, may grow well in stored donor blood and cause a fatal sepsis in recipient Bacteria on skin, if present, may grow well in stored donor blood and cause a fatal sepsis in recipient Use gauge needle to collect blood from a single venipuncture within 15 minutes Use gauge needle to collect blood from a single venipuncture within 15 minutes Collect 450 +/- 45 mLs of blood Collect 450 +/- 45 mLs of blood

Collecting Unit Gloves should be worn. Gloves should be worn. Single venipuncture Single venipuncture Mix blood bag frequently Mix blood bag frequently Monitor volume of blood drawn Monitor volume of blood drawn Collection should be within 15 minutes Collection should be within 15 minutes

Donor Reactions Syncope (fainting) Syncope (fainting) Remove needle immediately Remove needle immediately Hyperventilation Hyperventilation Have donor rebreathe into paper bag. Have donor rebreathe into paper bag. Nausea/vomiting Nausea/vomiting Twitching/muscle spasms Twitching/muscle spasms Hematoma Hematoma Convulsions – rare, get immediate assistance Convulsions – rare, get immediate assistance Cardiac difficulties Cardiac difficulties Record ANY donor reactions Record ANY donor reactions

Post-Phlebotomy Care Donor applies pressure for 5 minutes Donor applies pressure for 5 minutes Check and bandage site Check and bandage site Have donor sit up for few minutes Have donor sit up for few minutes Have donor report to refreshment area for additional 15 minutes of monitoring Have donor report to refreshment area for additional 15 minutes of monitoring

Post-Phlebotomy Instructions Eat/drink before leaving Eat/drink before leaving Wait until staff releases you Wait until staff releases you Drink more fluids next 4 hours Drink more fluids next 4 hours No alcohol until after eating No alcohol until after eating Refrain from smoking for 1 hour Refrain from smoking for 1 hour If bleeding continues apply pressure and raise arm If bleeding continues apply pressure and raise arm Faint or dizzy sit with head between knees Faint or dizzy sit with head between knees Abnormal symptoms persist contact blood center. Abnormal symptoms persist contact blood center. Remove bandage Remove bandage THANK DONOR THANK DONOR

Testing Donor Blood CANNOT rely on previous testing CANNOT rely on previous testing Records must be kept for 5 years OR 6 months after product expires. Records must be kept for 5 years OR 6 months after product expires.

Serological Testing ABO/D typing ABO/D typing Antibody Screen – if positive, ID antibody, cannot make plasma products Antibody Screen – if positive, ID antibody, cannot make plasma products Antibodies to other blood group antigens which are present in the donor may react with recipient red cells resulting in a reaction. Antibodies to other blood group antigens which are present in the donor may react with recipient red cells resulting in a reaction.

Disease Testing Disease testing include: Disease testing include: HBsAG HBsAG HBc HBc HCV HCV HIV 1&2 HIV 1&2 HTLV I/II HTLV I/II RPR RPR NAT for HIV-1, HCV & WNV NAT for HIV-1, HCV & WNV

Results of Testing Tests for disease markers must be negative or within normal limits. Tests for disease markers must be negative or within normal limits. Donor blood which falls outside these parameters must be quarrantined. Donor blood which falls outside these parameters must be quarrantined. Repeat testing, if still abnormal must dispose. Repeat testing, if still abnormal must dispose. Optional tests – CMV testing, special antigen typing or sickle cell testing Optional tests – CMV testing, special antigen typing or sickle cell testing

Labeling Donor Units Component name Component name Unique donor number Unique donor number ABO group, D type (not required for plasma) ABO group, D type (not required for plasma) Interpretation of tests Interpretation of tests Type and volume of anticoagulant. Type and volume of anticoagulant. Storage temperature Storage temperature Expiration date Expiration date Name/address of collecting facility Name/address of collecting facility Reference to Circular of Information - n/ Reference to Circular of Information - n/ n/ n/ Donor classification Donor classification Results of testing Results of testing Essential instructions Essential instructions Pooled component information Pooled component information

Transfusion Service Testing The only repeat testing required is: The only repeat testing required is: ABO on red cell products ABO on red cell products D typing (IS) on D negative red cell products D typing (IS) on D negative red cell products Plasma products (FFP, CRYO, PLTS) do not require any testing. Plasma products (FFP, CRYO, PLTS) do not require any testing. Donor samples must be stored at 1-6C for at least 7 days after transfusion Donor samples must be stored at 1-6C for at least 7 days after transfusion ADSOL unit transfused today must save sprig for one week ADSOL unit transfused today must save sprig for one week Many facilities will pull a sprig from each donor during processing and save all sprigs for 49 days, regardless of expiration of unit Many facilities will pull a sprig from each donor during processing and save all sprigs for 49 days, regardless of expiration of unit

Summary Blood collection starts with screening of the donor to: Blood collection starts with screening of the donor to: Ensure they are healthy enough to donate Ensure they are healthy enough to donate Ensure they do not have transmissible diseases Ensure they do not have transmissible diseases Many organizations set standards and monitor all aspects of blood collection and administration. Many organizations set standards and monitor all aspects of blood collection and administration. Collection of blood must be done in such a manner as to ensure sterility of the component. Collection of blood must be done in such a manner as to ensure sterility of the component. Testing of donor blood includes serological testing for ABO/D typing, antibody screening, and testing for markers indicating infection. Testing of donor blood includes serological testing for ABO/D typing, antibody screening, and testing for markers indicating infection. The blood supply is NOT safe, only careful screening and testing can prevent, as much as possible, disease transmission. The blood supply is NOT safe, only careful screening and testing can prevent, as much as possible, disease transmission.