Imhm lec week 10 - DONOR SCREENING PDF

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DONOR SCREENINGGoverning Agencies related in total quality management and procedure responsible in regulating all of the processes and procedure in immunohematology laboratory ● AABB ➔ **American Association of Blood Banks *** o Established in 1947 o mission: establish and provide the highest standa...

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1 | SUBJECT DONOR SCREENING Governing Agencies -

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related in total quality management and procedure - responsible in regulating all of the processes and procedure in immunohematology laboratory AABB ➔ American Association of Blood Banks * o Established in 1947 o mission: establish and provide the highest standard of care for patients and donors in all aspects of transfusion medicine o An international association of blood banks that includes hospital and community blood centers, transfusion and transplantation centers, and individuals involved in transfusion medicine. ➢ Members of the Organization ▪ Medical laboratory technicians, ▪ Medical technologists, ▪ Registered nurses, ▪ Laboratory managers (chief medical technologist), ▪ BB Physicians, ▪ Transfusion medicine fellows, and ▪ Researchers involved in transfusion medicine. o The AABB has published books on transfusion medicine ✓ AABB Standards ✓ AABB Technical Manual

FDA➔ U.S. Food and Drug Administration * o Inspection of the Blood Bank center on an annual basis o Regulations for donor screening are outlined in the “Code of Federal Regulations (CFR)”. (formerly called CBER) o 1988: CBER was formed CBER is responsible for regulating the collection of blood and blood components used for transfusion and for the manufacture of pharmaceuticals derived from blood and blood components ** CBER→ Center for Biologics Evaluation and Research

** more specifically involved in donor screening regulations * ● CAP ➔ College of American Pathologist ● JCAHO➔ Joint commission on Accreditation of Healthcare Organization (now known as TJC) o maintain the physical facilities of all blood bank facilities Blood Bank vs. Blood Center ● ●

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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 Center is the donation center, screens donors, draws donors, performs testing on the donor blood, and delivers appropriate components to the hospital blood bank

DONOR SCREENING -

medical technologist are assign to do donor screening - Goal: safe and efficacious blood product towards recipient through getting the truth in terms of the donor ✓ Assess Medical History of the donor ✓ (mini) Physical examination ✓ Serologic testing of the donor – confirms the transmissible infection Medical History and Physical Exam Is designed to answer two questions: (1) Will a donation of approximately 450 mL of whole blood at this time be harmful to the donor? – protect the donor (2) Could blood drawn from this donor at this time potentially transmit a disease to the recipient? – protect the patient Donor Questionnaire form: Registration ● ● ● ● ● ●

Name (Full name) Date and Time of Donation Address Telephone/ contact number: Gender Age or date of Birth: o

Age classification: ALLOGENEIC VS. AUTOLOGOUS

2 | SUBJECT ▪ ALLOGENEIC DONATION ➔ ≥17 Yrs. Old – no upper age limit ▪

AUTOLOGOUS DONATION➔ donor patient – blood donated is for his/her self – no age restriction

Consent to Donate ●

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Donors should be given educational materials informing them of the risks of the procedure. Signs and symptoms associated with the human immunodeficiency virus infection and AIDS, and the opportunity to decline from the donation process if they believe their blood is not safe or they are uncomfortable with the procedure. (right to refuse)

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Medical History ●

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Obtaining an accurate medical history of the donor is essential to ensure benefit to the recipient. The interviewer should be familiar with the questions, and the interview should be conducted in a secluded area of the blood center. The questions are designed so that a simple “yes” or “no” can be answered but elaborated if indicated. The medical history is conducted on the same day as the donation. Medications the donor taking are present in plasma, may cause deferral Infections the donor has may be passed to recipient (critical: HIV, HBV), may be cause for deferral

TEMPORARY DEFERRAL ●

Taking antibiotics for an infection or for prophylaxis after dental surgery, If viral hepatitis before the age of 11 year ● active disease under the treatment such as cold, flu, tuberculosis, syphilis, infections, curable disease of the heart, lung, kidney, liver and GI tract ● alcohol intake THREE YEARS DEFERRAL ●

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BLOOD DONATION DEFERRAL ●

Not called Reject

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Patients may be deferred from donating blood and tagged as permanent deferral, Temporary deferral , 3 years deferral, one-year/ 12 months deferral, 4 weeks/ 1 month deferral, 2 weeks deferral, 48 hours deferral, etc…

ONE-YEAR / 12 MONTHS DEFERRAL ● ●

A donor who has been hospitalized for AIDS, Persons with clinical or laboratory evidence of HIV infection, Tegison or

Persons who have been treated for malaria should be deferred for 3 years following therapy. Those who have had malaria, immigrated from, or lived in an endemic area are deferred for 3 years (Palawan, Sulu, Occidental Mindoro, Sultan Kudarat)

** Malaria – neglected tropical disease

PERMANENT DEFERRAL / INDEFINITE DEFERRAL ●

etretinate intake (for severe psoriasis), confirmed positive test for HBsAg after the 11th birthday confirmed positive test for hepatitis B surface antigen (HBsAg), A person with a history of hemophilia A or B, von Willebrand’s disease, or severe thrombocytopenia must be permanently deferred Positive HTLV 1 or 2, A history of babesiosis or Chagas’ disease is cause for indefinite deferral, Positive hepatitis C test result, Positive anti-HBc test result, Men who have engaged in sex with another man since 1977 should be permanently deferred because stages of HIV is long Skin lesions: Prior to donation, the donor’s arms should be inspected for skin lesions. Evidence of skin lesions (e.g., multiple puncture marks) is cause for indefinite deferral

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Persons who have had sex with any person who is a past or present IV drug user. Persons who have had sex with any person with hemophilia or related blood disorder who has received factor concentrates should be deferred for 12 months. women who have had sex with men who have had sex with another man even once since 1977

3 | SUBJECT ● Donors who have been exposed to blood or body fluids via an accidental needlestick or other injury. ● Person who received a tattoo. ● Person who received blood transfusion, other human tissues. ● Syphilis or gonorrhea or treatment for either or a reactive screening test (Rapid Plasma Reagin [RPR]) for syphilis should be deferred for 12 months ●

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A person who has been subjected to a correctional institution in the past 12 months. Individuals who have been incarcerated for more than 72 consecutive hours during the previous 12 months be deferred for 12 months from their last date of incarceration Vaccination against Hepatitis B, Anti-Rabies vaccination

Confidential Unit Exclusion/ CUE ●

CUE is not mandated by the AABB Standards or the FDA. o Most blood centers include the CUE as part of the donation process. ● The CUE provides; o an opportunity for those donors who felt pressure to donate in the workplace or at a community blood drive to indicate their blood should not be transfused. ● There are many ways this can be carried out; most procedures avoid face-to-face contact with the donor representative for answering the question “should my blood be used for donation?” ●

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8 WEEKS / 56 DAYS DEFERRAL ●

Sticker indications: USE : the blood may be given to another DON’T USE : The blood will not be given to another (it will be destroyed)

Allogeneic blood donations – to replenish the blood

4 Weeks / 1 month Deferral ● ●

Vaccination against German measles, chickenpox. Taking drugs like Accutane or Proscar (for acne) should be deferred from donating blood for at least 1 month after the last dose.

PHYSICAL EXAMINATION ●

2 WEEKS DEFERRAL ●

Donors receiving a live attenuated or bacterial vaccine such as measles (rubeola), mumps, polio, typhoid, or yellow fever, there is a 2-week deferral.

3 DAYS DEFERRAL ●

Piroxicam, aspirin or anything with aspirin. (blood thinners)

48 HOURS DEFERRAL ●

Apheresis blood donation o

apheresis – special collection wherein dealing with specific blood component placed on a specific blood bag

12 HOURS DEFERRAL ●

Alcohol intake

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Provides a general screening of health and vital signs to ensure good health on the day of donation. The donor should appear in relative good health to the trained donor historian. Specific screening assessments are performed and the results are recorded in the donor logbook record

General appearance: observe the prospective donor for presence of excessive anxiety, drug or alcohol influence, or nervousness. ● Body Weight: Standards mandates a minimum of 110 pounds/ 50 kg; OR maximum of 10.5 ml/kg of donor weight for whole blood collection inclusive of pilot tubes for testing. o If the donor weighs less than 110 pounds: adjust the ff: or defer ▪ Volume of Blood to be extracted: ▪ Volume of anticoagulant:

4 | SUBJECT ▪ Volume of anticoagulant to be removed from the blood bag: SAMPLE PROBLEM: THE DONORs WEIGHT IS 100Lbs. ● ● ●

WHAT IS THE AMOUNT OF BLOOD TO BE DRAWN? HOW MUCH ANTICOAGULANT IS NEEDED? HOW MUCH ANTICOAGULANT SHOULD BE REMOVED?

Formula For less than the minimum standard:

the hematocrit level for allogeneic donation. ≥ 38% for allogeneic donation ● For autologous donation: Hgb ≥ 11g/dL and ≥ 33% Hct o The methods used for measuring hemoglobin include the copper sulfate (SG of 1.053; 30mL) method or point-of-care instruments using spectrophotometric methodology. (max of 25 tests) → sink of CuSO4 within 15 seconds = acceptable o Hematocrit level can be measured manually by centrifugation (microhematocrit centri) or by computing from the RBC count and MCV result. Autologous Donation ● ● ●

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PHYSICAL EXAMINATION ●

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Temperature: Standards mandates the donor temperature must be less than or equal to 37.5C or 99.5F Pulse rate: 50-100 bpm; if athlete: less than 50 is still acceptable Blood pressure: The systolic blood pressure of a potential donor should be , ≤ 180 and the diastolic less than or equal to ≤100 Hemoglobin Concentration: The hemoglobin level of the donor should be ≥ 12.5 g/dL, and

An autologous donor is one who donates blood for his or her own use Safer than allogeneic blood. There is no risk of disease transmission, transfusion reactions, or alloimmunization to white blood cells, RBCs, platelets, or plasma proteins. Autologous units are labeled differently than allogeneic units and directed units. The former generally have a distinct green label and tag.

➢ There are four different types of autologous donation: o Preoperative collection o Acute normovolemic hemodilution o Intraoperative collection o Postoperative collection 4 Types of Autologous Donation Preoperative Collection ●

Indications for preoperative collection include patients undergoing orthopedic procedures, vascular surgery, cardiac or thoracic surgery, and radical prostatectomy.

5 | SUBJECT ● The last blood collection should occur no sooner than 72 hours before the scheduled surgery to allow for volume repletion. ● A minimum hemoglobin/hematocrit level of 11 g/dL and 33 percent. ● No deferral of the donor-patient except when there is a risk of bacteremia

Directed Donors ●

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A directed donation is a unit collected under the same requirements as those for allogeneic donors, except that the unit collected is directed toward a specific patient. A tag should be placed on the blood bag to indicate its use.

Acute Normovolemic Hemodilution ●

This type of autologous collection involves removal of whole blood from a patient with infusions of crystalloid or colloid before surgical blood loss. o crystalloid/ colloid → blood substitute/ replacement fluid (NSS, albumin, fresh frozen plasma/ plasma) ● Example: In one case, a 65-year-old patient scheduled for a radical prostatectomy underwent an ANH. Approximately 2360 g of blood was removed and replaced with 1500 mL of colloids and 2000 mL of crystalloid solution. Retransfusion was started after a blood loss of 1800 mL. o The patient remained hemodynamically stable throughout the operation Intraoperative Collection ●

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This type of autologous collection involves collecting and reinfusing blood lost by a patient during surgery. Most programs use devices that are capable of collecting the shed blood, washing it with saline, and then concentrating the RBCs with hematocrits in the range of 50 to 60 percent. The vacuum setting on the device should be less than 100 torr to guard against possible hemolysis of recovered blood. This type of collection has been used in cardiothoracic, major orthopedic, and cardiac surgery and vascular surgeries such as liver transplantation, DIC

Postoperative Collection ● ● ● ●

Blood is collected from a drainage tube placed at the surgical site. This blood is characterized as being dilute, partially hemolyzed, and defibrinated. It is recommended that no more than 1400 mL be reinfused. Blood must be reinfused within 6 hours of collection or it is to be discarded

Pheresis Donation -

special procedure wherein only specific blood component is taken in the blood bag ● Plateletpheresis ● Plasmapheresis ● Leukopheresis ● Double RBC pheresis ● Stem cell pheresis

Plateletpheresis ●

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The interval between donations is at least 2 days, not to exceed more than twice a week or more than 24 times a year. Donors who have ingested aspirin or aspirin-containing medications are deferred

Leukopheresis ●

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Special agents are required in the procedure for collection of granulocytes from the leukopheresis donor. These may include hydroxyethyl starch, corticosteroids, or growth factors such as granulocyte-colony stimulating factor.

Double RBC Pheresis ●

Both the AABB and FDA have approved procedures for removal of two allogeneic or autologous RBC units every 16 weeks by an automated method.

6 | SUBJECT Whole Blood Collection, Donor Identification ●

Whole blood Collection o This procedure is to be done only by trained personnel working under the direction of a qualified licensed physician. ● Donor Identification o A numeric or alphanumeric system is used to link the donor to the donor record, pilot tubes, blood container, and all components made from the original collection. ** avoid duplicate number/ labeling mistakes o AABB Standards states that the trained phlebotomist must identify the donor record and ensure that the donor name and identification numbers match (ask to state the name) ● Aseptic technique o Most blood centers use an iodine compound such as or PVP (Polyvinylpyrrolidone Iodine) or Polymeriodine Complex COLLECTION PROCEDURE 1. Confirm donor identity, and make the donor as comfortable as possible (relaxed, feel at home) 2. Select a firm large vein in the antecubital space that is free of any skin lesions or scarring. Both arms should be inspected. 3. Prepare the site using an FDA-approved cleansing method (aseptic technique) 4. Inspect the blood bags for any defects or discoloration. 5. Ensure the balance system is adjusted to the volume being drawn; ensure counterbalance is level. Place hemostats on the tubing to prevent air from entering the line. 6. Reapply tourniquet or blood pressure cuff (40 to 60 mm Hg) to increase distention of the vein. 7. Uncover the sterile gauze, and perform the venipuncture immediately. Check the position of the needle, and tape the tubing to the donor’s arm to hold the needle in place. Cover with a sterile gauze. 8. Release the hemostat, and ask the donor to open and close hand every 10 to 12 seconds during the collection procedure. 9. Reduce the pressure on the cuff to approximately 40 mm Hg. 10. Continue to monitor the patient throughout the entire collection process. The donor should never be left unattended. Mix blood and

anticoagulant periodically during the procedure. (e.g. every 45 seconds) 11. When the primary bag has tripped the scale, the donor can stop squeezing, and tubing can be clamped. ■ A unit containing a volume of 405 to 550 mL should weigh between 429 to 583 g plus the weight of the container and anticoagulant. ■ The conversion 1.06 g/mL is used to convert grams to mL. ■ If the volume collected is in the low volume range (300 to 404 mL), the unit must be labeled as a Low Volume Unit and fresh frozen plasma (FFP) cannot be made from this unit as it would not contain adequate levels of coagulation factors. 12. Before the needle is removed from the donor’s arm, pilot tubes are filled for serologic testing. The pressure is reduced to 20 mm Hg or less and, depending on the tubing of the bag, the tubes are filled: ■ In-line needle. A hemostat or metal clip is used to seal tubing distal to the needle. The connector is opened, the needle is inserted into the pilot tube, the hemostat is removed, and tubes are filled. The donor needle can now be removed. ■ Straight-tubing assembly. Place hemostats approximately four segments from the needle. Tighten the loose knot made previously in the tubing; release the hemostats, and strip a segment of tubing between knot and needle. Secure hemostat and cut tubing in a stripped area of segment. Fill required tubes by releasing hemostats. This is an open system, and appropriate biohazard precautions should be followed. Reapply hemostats and remove needle from donor’s arm. 13. Once the needle has been removed from the donor’s arm, apply pressure over gauze, and ask the donor to raise his or her arm(above the heart), continuing to exert pressure over the site. When the bleeding has stopped, the donor can lower his or her arm, and an appropriate bandage can be applied. ** 15-30 minutes wag muna patayuin 14. The needle assembly should be discarded into an appropriate biohazard receptacle. The

7 | SUBJECT tubing should be stripped to allow proper mixing of anticoagulant/preservative with blood. 15. Make a hermetic seal to the segments, and apply an appropriate identification label to one segment for storage. A dielectric sealer is generally used for heat sealing. Place blood at the appropriate temperature. Units in which platelets will be made must be stored at room temperature (20C to 24C) with continuous agitation; all others can be stored at 1Cto 6C

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Remove the tourniquet and withdraw needle 2. Place cold compresses on the donor’s forehead 3. Raise the donor’s legs above the level of the head 4. Loosen tight clothing and secure airway 5. Monitor vital signs If the donor starts to feel nauseated or starts to vomit, the following instructions apply: 1. Instruct the donor to breathe slowly 2. Apply cold compresses to the forehead 3. Turn the donor’s head to one side and provide an appropriate receptacle 4. The donor may be given water after vomiting has ceased

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Donor Bleeding ● ● Post Donation Instructions ■

Most blood centers have a designated post donation area where donors can sit and replenish their fluids.

Needle Insertion: 45 deg angle then reduce to 10-20 deg angle Time allocation for Procedure: ≤15 MINUTES; if exceed the blood is accepted...