SOP Revision 2

Transcription

1 SOP Revision 2

2 To determine if you are eligible to donate we will: Ask about your health and travel Ask about medicines you are taking or have taken Ask about your risk for infections that can be transmitted by blood especially AIDS and viral hepatitis Take your blood pressure, temperature and pulse Take a blood sample to be sure your blood count is acceptable If you are eligible to donate we will: Clean your arm with an antiseptic. Tell us if you have any skin allergies Use a new, sterile, disposable needle to collect your blood Do not donate if you: Have AIDS or have ever had a positive HIV test Have EVER used needles to take any drugs not prescribed by your doctor Are a male who has had sexual contact with another male, IN THE PAST 12 MONTHS Have EVER taken money, drugs or other payment for sex Have had sexual contact in IN THE PAST 12 MONTHS with anyone described above Have had syphilis or gonorrhea IN THE PAST 12 MONTHS Have been in juvenile detention, lockup, jail or prison for more than 72 consecutive hours IN THE PAST 12 MONTHS DONOR ELIGIBILITY SPECIFIC INFORMATION Certain diseases, such as AIDS and hepatitis, can be spread through sexual contact and enter your bloodstream. We will ask specific questions about sexual contact. What do we mean by sexual contact? The words have sexual contact with and sex are used in some of the questions we will ask you, and apply to any of the activities below, whether-or-not a condom or other protection was used: Vaginal sex (contact between penis and vagina) Oral sex (mouth or tongue on someone s vagina, penis, or anus) Anal sex (contact between penis and anus) HIV/AIDS risk behaviors HIV is the virus that causes AIDS. It is spread mainly by sexual contact with an infected person OR by sharing needles or syringes used by an infected person for injecting drugs. Your blood can transmit infections, including HIV/AIDS, even if you feel well and all your tests are normal. This is because even the best tests cannot detect the virus for a period-of-time after you are infected. DO NOT donate to get a test! If you think you may be at risk for HIV/AIDS or any other infection, do not donate simply to get a test. Ask us where you can be tested outside the blood center. The following symptoms can be present before an HIV test turns positive: Fever Enlarged lymph glands Sore throat Rash DO NOT donate if you have these symptoms! Travel to or birth in other countries Blood donor tests may not be available for some infections that are found only in certain countries. If you were born in, have lived in, or visited certain countries, you may not be eligible to donate.

3 BLOOD DONOR EDUCATIONAL MATERIAL FOR EBOLA VIRUS DISEASE OR INFECTION This information applies following the CDC s classification of one or more countries as having widespread transmission or cases in urban areas with uncertain control measures at this link: west-africa/distribution-map.html. Blood collection facilities must reduce the risk of collecting blood and blood components from a donor who may be infected with Ebola virus. It is possible that an Ebola virus infected person may not have symptoms of infection during the incubation period. In addition, anyone who has EVER had Ebola virus infection or disease may be at risk for transmitting the virus through blood donation, regardless of the length of time since recovery. Ebola virus is transmitted from human to human by direct exposure to body fluids (such as blood, urine, stool, saliva, semen, vaginal fluids or vomit) from infected individuals. Healthcare workers, and family and friends providing care may have direct exposure to body fluids of infected patients. If direct exposure occurs, a person is at high risk of developing Ebola virus infection and must not donate blood or blood components. DO NOT DONATE BLOOD if: You have EVER had Ebola virus disease or infection In the PAST 8 WEEKS, you have lived in, or travelled to, a country with widespread Ebola virus disease or infection. In the PAST 8 WEEKS, you have had sexual contact with a person has EVER had Ebola virus disease or infection, regardless of the length of time since recovery. In the PAST 8 WEEKS, you have had direct exposure to the body fluids (such as blood, urine, stool, saliva, semen, vaginal fluids or vomit) of a person with Ebola virus disease or infection, including a person under investigation. In the PAST 8 WEEKS, you have you been notified by a public health authority that you may have been exposed to a person with Ebola virus disease or infection. PLEASE CONTACT THE DONOR CENTER, if you develop the following symptoms within the 8-week period following donation: Fever Diarrhea Severe Headache followed by: Vomiting Muscle Pain and Weakness Abdominal Pain Fatigue hemorrhage (bleeding or bruising) WHAT HAPPENS AFTER YOUR DONATION To protect patients, your blood is tested for several types of hepatitis, HIV, syphilis, and other infections. If your blood tests positive, it will not be given to a patient. There are times when your blood is not tested. If this occurs, you may not receive any notification. You will be notified about any positive test result which may disqualify you from donating in the future. The blood center will not release your test results without your written permission unless required by law (e.g. to the Health Department).

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5 SOME MEDICATIONS MAY AFFECT YOUR ELIGIBILITY TO DONATE BLOOD. PLEASE TELL US IF YOU... Are being treated with the following types of medications... Anti-platelet agents (usually taken to prevent stroke or heart attack) or have taken... which is also called... anytime in the last... Feldene piroxicam 2 days Effient prasugrel Brilinta ticagrelor 7 days Plavix clopidogrel Ticlid ticlopidine 14 days Zontivity vorapaxar Xarelto rivaroxaban Fragmin dalteparin Lovenox enoxaparin Pradaxa dabigatran 2 days Anticoagulants or blood thinners (usually to prevent blood clots in the legs and lungs and to prevent strokes) Eliquis Savaysa Coumadin Warfilone Jantoven Heparin, low apixaban edoxaban warfarin molecular 7 days weight heparin heparin (unless listed separately) Arixtra fondaparinux Accutane Amnesteem Absorica Acne treatment Claravis isotretinoin Myorisan 1 Month Sotret Zenatane Hair loss remedy Propecia finasteride Proscar finasteride Prostate symptoms Avodart Jalyn dutasteride 6 Months Basal cell skin cancer Erivedge vismodegib Odomzo sonidegib 24 months Relapsing multiple sclerosis Aubagio teriflunomide 24 months Psoriasis Soriatane acitretin 36 months Tegison etretinate Ever Hepatitis B Hepatitis exposure Immune HBIG 12 months Globulin

6 Experimental Medication or Unlicensed (Experimental) Vaccine Growth hormone from human pituitary glands* Insulin from Cows (Bovine or Beef Insulin) manufactured in the United Kingdom* 12 months, or as indicated by Medical Director Ever Ever * No longer available in US DO NOT discontinue medications prescribed or recommended by your physicians in order to donate blood. Some medications affect your eligibility as a blood donor, for the following reasons: Anti-platelet agents affect platelet function, so people taking these drugs should not donate platelets for the indicated time; however, you may still be able to donate whole blood or red blood cells by apheresis. Anticoagulants or "blood thinners" are used to treat or prevent blood clots in the legs, lungs, or other parts of the body, and to prevent strokes. These medications affect the blood s ability to clot, which might cause excessive bruising or bleeding when you donate; however, you may still be able to donate whole blood or red blood cells by apheresis. Isotretinoin, finasteride, dutasteride acitretin and etretinate can cause birth defects. Your donated blood could contain high enough levels to damage the unborn baby if transfused to a pregnant woman. Erivedge (vismodegib), Odomzo (sonidegib), Aubagio (teriflunomide) can cause birth defects or the death of an unborn baby if transfused to a pregnant woman. Growth hormone from human pituitary glands was prescribed for children with delayed or impaired growth. The hormone was obtained from human pituitary glands, which are in the brain. Some people who took this hormone developed a rare nervous system condition called Creutzfeldt-Jakob Disease (CJD, for short). Insulin from cows (bovine, or beef, insulin) is an injected medicine used to treat diabetes. If this insulin came to the United States from the United Kingdom (where mad cow disease has occurred) it could contain material from cattle that have mad cow disease. Although no cases of the human type of mad cow disease have been reported in people treated with bovine (beef) insulin, there is concern that someone exposed to mad cow disease through beef insulin could transmit it to someone who receives their blood. Hepatitis B Immune Globulin (HBIG) is an injected material used to prevent hepatitis B infection following a possible or known exposure to hepatitis B. HBIG does not hepatitis B infection in every case, therefore, persons who have received HBIG must wait to donate blood. Experimental Medication or Unlicensed (Experimental) Vaccine is usually associated with a research study, and the effect on the safety of transfused blood is unknown. prevent Donors SHOULD NOT discontinue medications prescribed or recommended by their physician in order to donate blood.

7 These lists were prepared from the FDA Guidance for Industry Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, updated January 2016 vcjd countries of risk - United Kingdom Area Country Type of Travel or Residence Time Period Deferral Period Reason for Deferral UK Includes: 3 months or more Between Channel Islands England Falkland Islands Gibraltar Isle of Man Northern Ireland Scotland Wales Received a blood transfusion 1980 Present Indefinite Possible risk of Variant Creutzfeldt-Jakob Disease (vcjd). (there is no test for vcjd)

8 vcjd countries of risk -Europe Area Country Belgium Germany Netherlands Type of Travel or Residence 6 months or more associated with US military base. Time Period Between Deferral Period Reason for Deferral Greece Italy Portugal, including the Azores Spain, including the Canary Islands and Spanish North African territories Turkey 6 months or more associated with US military base. Between Indefinite Possible risk of Variant Creutzfeldt- Jakob Disease (vcjd). (there is no test for vcjd) France, including its overseas departments (e.g., Martinique and others) Received a blood transfusion 1980 Present Continue

9 vcjd countries of risk -Europe Area Country All Countries on this list Albania Austria Belgium Bosnia-Herzegovina Bulgaria Croatia Czech Republic Denmark Finland France, including its overseas departments (e.g., Martinique and others) Germany Greece Hungary Republic of Ireland Italy Kosovo Liechtenstein Luxembourg Macedonia Montenegro Netherlands Norway Poland Portugal, including the Azores Romania Serbia Slovak Republic Slovenia Spain, including the Canary Islands and Spanish North African territories Sweden Switzerland Turkey Type of Travel or Residence 5 years or more Time Period 1980 Present Deferral Period Indefinite Reason for Deferral Possible risk of Variant Creutzfeldt- Jakob Disease (vcjd). (there is no test for vcjd)

10 In the past 3 years, have you been outside the United States or Canada? Malaria is a serious and sometimes fatal disease that can caused by any of the following four Plasmodium species: P. falciparum; P. malariae; P. ovale; or P. vivax. About 1,500 cases of malaria are diagnosed in the United States each year, the vast majority of which are found among travelers and immigrants returning from countries where malaria transmission occurs, such as sub-saharan Africa and South Asia. People who contract malaria typically become very sick with high fevers, shaking chills and flu-like illness. Although malaria can be fatal, illness and death from this disease usually can be prevented. Check the CDC Yellow Book to see if you traveled to a malaria endemic area.

11 INFORMED CONSENT FOR PLASMAPHERESIS AND HIV TESTING 1. I understand that plasmapheresis is a process in which the liquid portion of the blood plasma is separated from the red cells. I understand an automated apheresis machine will be used, this process involves: a) A sterile, one-time use kit will be used for this procedure. b) During plasmapheresis donors rest on a donation bed. A needle is placed into a vein in the crux of whichever arm has the most robust vein. c) Removal of up to 15% of my total blood volume at one time. Whole blood is mixed with anticoagulant and separated from the red cells. The red cells are then returned to me. This process continues for several cycles. d) I may receive up to 250ml of anticoagulant (blood thinner). 2. I understand I can donate plasma one time in seven days, 3. I understand that more frequent donations could cause me complications. I will not participate in more than one plasmapheresis program at a time, and that the donation of Whole Blood or Red Blood Cells while participating in the plasmapheresis program may serve as a basis for an 8-week deferral or a 16- week deferral for a Red Blood Cell donation. 4. The pre-qualification process can take up to 1 hour. The process includes New Donor registration, donor education, health history questions and hands-on physical exam and blood tests. I will be notified within 2-3 days, if I qualify for the plasmapheresis program. 5. Routine donation sessions usually take less than 60 minutes total. You are encouraged to stay in the center after your donation and enjoy a healthy snack and juice. 6. I understand that prior to donation, I must provide written informed consent for the plasmapheresis procedure. 7. I understand my informed consent will be maintained electronically in my NuPlasma donor record file. Further, I understand that blood establishment records, including donor records, are subject to inspection by FDA and, if applicable, other regulatory agencies. 8. I acknowledge that before I signed the first copy of this informed consent, a qualified licensed nurse or physician explained the hazards of the procedure. Prior to signing consecutive consent forms I read about the potential hazards. The hazards of the procedure include the following: a) Light-headedness b) Fainting c) Vomiting d) Hyperventilation e) Hematoma formation at the site of venipuncture f) Syncopal reactions due to hypovolemia g) Post-Donation iron deficiency Reactions that are unique to plasmapheresis collection procedures include: a) Allergic symptoms such as skin redness, itching, and hives b) Chills (induced by infusion of room temperature saline or donor blood) c) Moderate hypocalcemia due to chelation of calcium by metabolized citrate (caused by infusion of anticoagulants containing citrate). This reaction is usually manifested by: Unusual taste or smell Tingling around the mouth or fingers

12 Muscle discomfort, muscle twitching, or spasms. d) Symptoms of severe hypocalcemia although rare include: Tetany Convulsions Cardiac arrhythmias e) Occasionally mild, temporary facial redness or flushing of donors has been reported, most often during return blood cycles. f) Hemolysis, air embolism and blood clotting g) Blood loss from the inability to return red blood cells during automated plasmapheresis, which may result in: The procedure being terminated, and Deferral from donation for 8 weeks. h) Complications such as a hematoma or localized infection at the venipuncture site. i) Nausea, vomiting, light-headedness, fainting, or seizures; j) Bleeding, infection, pain, and the potential need for additional procedures in the event of complications. 9. I understand that frequent plasmapheresis donors might experience changes in blood protein levels, hemoglobin, IgG levels which may necessitate deferment or removal from the program. I understand that NuPlasma will collect samples to test mean corpuscular volume (MCV), which is a measure of the average size of the red blood cells and is performed to diagnose anemia. Additionally, a total serum protein (SPE), including immunoglobulin levels, these samples will be collected and tested at least every 4 months, and if the results are not within required limits, I will be removed from the program until the values return to normal. Further, donor screening will be completed prior to each donation to check my total protein levels, blood pressure, temperature, pulse, weight, height and hematocrit and hemoglobin. If any of these levels are outside the required range, I understand I will be temporarily deferred from donating until they return to normal. 10. Donor Responsibilities: a) To reduce the risk of infection, I should leave my bandage in place for 2 hours after each donation. b) I understand I must actively participate in the accurate identification of myself. I will be asked for my social security number and my photograph will be taken to aid in my identification. I understand I will be asked for my full name and date of birth during each step of the process. I have provided NuPlasma a valid form of identification and my Social Security number, to ensure I am registered accurately. c) I understand I should have a nutritious meal before donating. I will drink plenty of noncaffeinated, non-alcoholic beverages before and after donation. d) If at any time in the donation process, I am not feeling well, I will notify a member of the staff to assist me. e) If I experience a reaction after leaving NuPlasma I agree to call the center or seek medical evaluation or treatment. If I refuse or decline to seek medical treatment or transportation to the emergency room or medical facility, I am assuming the risk that my condition may become worse or cause additional medical complications to develop, up to, and including death. 11. I consent to have my blood tested for the presence of transmissible disease agents and other antibodies. If the results of tests for communicable disease agents are reactive, positive, or outside of normal limits the consequences could include: a. Detection of infectious agents such as Human Immunodeficiency Virus (HIV), or hepatitis, West Nile Virus, Zika Virus. If I test positive for a transmissible disease I agree to be contacted by mail. b. I understand I may be temporarily or permanently deferred from donation, as required by FDA and State regulations. c. I understand my results will be reported to public health officials per state law, and a subsequent public health investigation may occur. d. I understand that I should not donate in order to receive infectious disease testing. 12. I understand there is a "window period" for infection (the time interval early in infection during which tests for diseases such as HIV or hepatitis may be negative although infection may still be transmitted). I

13 promise I am not participating in donation as a means of being tested, and that I am not at risk for transmitting HIV infection to others through this donation. 13. Female donors: I understand I cannot donate if I am pregnant. I will report any pregnancies I have ever had in the past to NuPlasma medical staff, and if I become pregnant I will stop donating until 6 weeks post-partum. Further, I consent to testing for Human Leukocyte Antigen (HLA), an antigen that can sometimes be developed during pregnancy, and is known to cause a rare lung disease in patients that receive a transfusion. 14. I have read and understand The NuPlasma Blood Bank pre-donation information as it applies to the plasmapheresis donation I am about to make. To my knowledge, I have answered all questions truthfully and accurately. I understand the information about the spread of the AIDS virus by blood and blood products. I agree not to donate blood/blood components for transfusion to another person if I think I am at risk for spreading the AIDS virus. 15. I voluntarily donate my blood/blood components to The NuPlasma Blood Bank to use in any way it deems advisable. For that purpose, I consent to related tests, examinations, and procedures determined appropriate by The NuPlasma Blood Bank. 16. I understand that trained personnel will insert a needle into my arm to collect my plasma. The donation of plasma is not completely risk free. I have read and understand these risks as presented in the predonation information. I have been given opportunity to ask questions and all the questions I have asked have been answered to my satisfaction. 17. I understand that I am free to withdraw my consent and to discontinue participation in the plasmapheresis program at any time. THANK YOU FOR DONATING TODAY