Chapter 13 Donor Screening and Component Preparation

Donor Screening and Component Preparation

• The initial phases of the blood banking process involve selecting blood donors and collecting/processing donor units
• These steps lead to transfusion of life-saving blood products for patients

Governing Agencies

• Standard regulations for donor selection/collection established by various organizations/agencies

U.S. Food and Drug Administration (FDA)

• An agency that regulates donor screening
• Regulations outlined in Code of Federal Regulations (CFR), parts 211, 600-799
• Blood is considered both biologic and a drug under FDA regulations
• Center for Biologics Evaluation and Research (CBER) formed in 1988
• CBER regulates collection of blood/components for transfusion and blood-derived pharmaceuticals
• CBER develops/enforces quality standards, inspects establishments and monitors reports of errors, accidents, and adverse events
• Early 1990s: FDA began treating blood establishments like drug manufacturers, requiring strict compliance toward all aspects of transfusion medicine
• They also establish/maintain regulations and inspect collection/processing centers
• The FDA licenses collection and processing facilities, blood products/derivatives, and reagents used in processing/testing

AABB

• Formerly known as the American Association of Blood Banks, established in 1947
• International association of blood centers, transfusion/transplantation services, and transfusion medicine individuals
• AABB provides a voluntary inspection/accreditation program for members meeting CMS standards and CLIA '88
• Mission is to establish/provide the highest care standards for patients/donors in transfusion medicine
• AABB published on transfusion medicine; AABB Standards for Blood Banks and Transfusion Services and AABB Technical Manual help with donor screening

College of American Pathologists

• CAP provides a voluntary inspection/accreditation program for member institutions
• Transfusion services usually part of clinical laboratory departments in a hospital, thus included in CAP inspection
• CAP inspections approved by CMS and meet CLIA requirements

Donor Screening

• Comprised of medical history requirements, (mini) physical exam, and serologic testing of donor blood
• Any area may disqualify potential donor
• Medical history information and physical examination are designed to answer two questions:
  • Will donation of ~450 mL of whole blood be harmful to the donor?
  • Could blood drawn from donor potentially transmit disease to recipient?

Registration

• Blood collection facilities must confirm donor identity/link donor to existing records, according to AABB Standards
• Most facilities require photo identification, like driver's license, passport, or school ID
• Every donor must be checked against permanent record of deferred donors to prevent ineligible donor donating again
• Collection facility information recorded on single donation record form or electronically:
  • Name (first, last, MI)
  • Date and time of donation
  • Address
  • Telephone
  • Gender
  • Age or date of birth: Minimum age for allogeneic donation is between 16 and 17 years (state laws vary)
  • No upper age limit for allogeneic donation
  • No age restriction for autologous donation; donor-patient must be evaluated by blood bank medical director
  • Consent to donate: Donors informed of blood donation and potential risks; must receive education about HIV/AIDS and risks of infection; donors cautioned against donating to get an HIV test
  • Donors must sign a consent statement -Additional information may be helpful:
  • Patient name for whom blood is intended (directed donation)
  • Donor race for unique phenotypes
  • Cytomegalovirus (CMV) status (some patients, like neonates, require CMV-negative blood in certain situations)

Medical History Questionnaire

• Obtaining a medical history is essential to ensure protection of donor and benefit to recipient
• Standardized questionnaire developed by task force of representatives from AABB, FDA, and blood/plasma industry
• Self-administered, but may be administered by trained donor historian if preferred
• Self-administered questionnaires must be reviewed by trained personnel before collection
• Interviewer familiar; interview should be conducted in a secluded area
• Questions are designed for a "yes" or "no" answer, but donors should elaborate
• Medical history performed on the same day as donation
• Approved version of the Donor History Questionnaire (DHQ) can be downloaded from the FDA website

Medical History Questions

Summary of DHQ questions with elaboration and explanation:

• Feeling healthy and well today? Donors should appear healthy with no cold, flu, or illness symptoms.
• Taking antibiotic or medication for an infection? Donors taking antibiotics are deferred.
• Taking medications on the Medication Deferral List? Questioners must investigate further
• Read educational materials? Prior to beginning Donor History Questionnaire, prospective donors must be provided information, understand high risk behavior and acknowledge that they have met the requirments for informed consent
• Aspirin within 48 hours? May not be suitable for platelet pheresis if yes.

Types of Deferral

• Temporary Deferral: Prospective donor unable to donate blood for a limited period of time:

  • EXAMPLE: Defer for 12 months from date of transfusion if the donor has received one and defer for 2 weeks from vaccination date if a donor has received vaccination for yellow fever

• The Prospective donor needs clarification on if the permanent deferral is indefinite EXAMPLE: Defer indefinitely if a "Donor states they have lived in England for 1 year in 1989" Defer permanently if the prospective donor will never be eligible to donate blood for someone else or some testing performed on the donor's previous donation EXAMPLE: Permanent deferral if the "Donor states that he or she has hepatitis C;.

• Female donors deferred for 6 weeks following end of pregnancy -12-month deferral if woman received blood during pregnancy

• Allogeneic whole blood donation interval is 8 weeks or 56 days

• FDA limits plateletpheresis procedures to no more than 24 in a calendar year -Apheresis donation: 48 hour window before donating whole blood -4 week deferral for infrequent plasma -Double red cell unit apheresis: 16 weeks

• 2 week deferral if the donor has received a live attenuated or bacterial vaccine (measles, mumps, oral polio, typhoid, or yellow fever) -Deferral for 4 weeks: live attenuated vaccine for German measles or chickenpox

• No Deferral: toxoids or killed or synthetic viral, bacterial, or rickettsial vaccines (diphtheria, hepatitis A, hepatitis B, influenza, lyme disease, pneumococcal polysaccharide etc -Donors should remain fever and symptom free

• Determine if the donor has developed any Vaccinia virus infection symptoms from the vaccine (new rash or skin sores since the time of contact from the vaccine)

• Exposure to certain causes a blood donors temporary or non-eligibility for donation. Exposure is assumed and is required to have their donation deferral at that time. (example "open wound, any broken skin, or mucous membranes.")

• Skin penetration that are nonsteril and contaminated with blood or body fluids requires deferal.

• Those using Plavix or Ticlid are not able to donate platelets for 14 days after the last dose. The use of either medication will not prohibit whole blood donations.

  • Meds to be aware that includes causes birth affect include "Proscar, Avodart Propecia. Accutane, Soriatane, or Tegison."

• Persons exposed to money, drugs or other payment for sex are not able to give a sample

• 12-month deferral if person or has resided to blood-borne pathogens

• deferrals for having sexual conduct for past 12 months.

• "living with" is considered residing in the same house, apartment, or dormitory

• 12 months for syphilis or gonorrhea in the past year .

• The agent can survive 1–5 days in cold storage at 3.11°C plate concentrates above RBCs support transfusion.

• Donors deferred who have been in juvenile detention, lockup, or jail, is deferred at least 12 months

• Leishmaniasis endemic: 12-month military and National Guard troops in Iraq _ From 1980 through 1996.

• Indefinite deferral: State that have spent 3 months or more on review Box 13-2 in the united states/ Canada

• Permanent Deferal: Received money, drugs, or other payment 12 blood bank director

The Physical Examination

• Donor center evaluates prospective donors general appearance, weight, temperature, pulse, blood pressure, hemoglobin, and presence of skin lesions
• Blood bank physician able to evaluate special considerations

General appearance

• Donor center representative should observe prospective donors for excessive anxiety, drug/alcohol influence, or nervousness in a gentle manner
• All done with the intention to not deter the donor

Weight

• Standards mandate not more than 10.5mL of blood/kg of donor weight for whole blood collection (including pilot tubes)
• Less than 100 pounds- amount of blood collected should be reduced along with that of anticoagulant- volume of blood and anticoagulant adjusted by formulas.
• Volume to collect = (donor's weight in kg/50) 450 mL*
• *Volume to collect/450 63 mL = reduced volume of anticoagulant 63 mL – above calculated volume = amount of solution to be removed"

Temperature

• Standardized temperature should be less than or equal to 37.5°C

Pulse

• Donors normal pulse needs to be from 50-100 bpm
  • The pulse counts require assessment of blood bank personnel to evaluate any irregularities

Blood pressure

• Syostolic: Potential donors blood pressure: not more than 180 mm Hg. -Diastolic: not more than 100mm Hg

Hemoglobin

• allogeneic donation must be equal to more than 12.5 g/dL and blood levels about 38% for Hemoclitic autologous donation is around 11 g/dL, hematocrit level of 3390- respectively- instruments for testing- hemogloben- spectrophotoometric methodology

Allogeneic

• standards mandate - before getting Allo - and apheresis- must get informmed consent from potential donors or potential transfusions -Minors are to have interceding law of what may/may not allow

Autologous Donors

• Autologous donors blood for his or her own use thus such as donor is considered to be a donor-patient
  • Advantage with autologous blood over allogeneic blood are to not increase disease for not cause infection- as well to having to risk overloads, misidentification the recipient in patient
• The Donor must be to understand why the patient is responsible for making the donation. -Donor has the right to provide the information of their body and conditions to allow blood -If the risks aren't met to complete blood can be possible for legal actions to pursue in such action Physical: -Donor's arms must be clean- If not; must be made note of- the possible contamination -Excessive anxiety -Blood pressure numbers must be recorded before starting process

Directed Donation

• A direction from a unit collected under the same requirements as for allogeneic donors, directed towards to a certain point on the allogeneic. -Must be able to have the required testing that can be able to used by patients - a system will be sure that the directed units from blood relatives and are all irradiated Apheresis Collection
• Is a system where is the process/component is drawing outside the blood
  • Automated force- separation of the blood parts Components separated: -Platelets -plasma -White blood -Red cells -Stem cells -Collection large amounts of intended components -Designed all for requirements as whole blood donation where standards have more to meet
• The Donor Requirements include both - the American Association of Blood donors.
• ASFA

Plateletpheresis

"More than 75% of the transfusions for plateletephresis derived.

• a unit is the range of four or 6 random transfusions for the same adults

• FDA guidelines require that the donation records of regular platelet pheresis donors be reviewed by a physician at least every 4 months." -The donor is to be under medical attention for the following reasons if they are having this procedure -The count is needed if has been had under 4 weeks. has been to be about 150,000/pL;

• 4-If less than 100mL cannot be retained because on pheresis is procedure

• The process are most common is where citrate is where they are vasovagel- has seen this under rare circumstances

• Plasmpheresis*: -The methods for collecting source Plasma, then manufactured from plasma derivative: Classfication of the different procedures : -classified of occasional or "serial

• Leukapheresis*
  - Drugs needed for donors to be more easier to collect during the time

• The FDA states to understand that any agent or drugs used to may stimulate for luekapheresis will not be the donors will give "a medical of the donor" as it can lead where cause one to lead to to a diseases
  --Hydroxyerthl Starch (HES) -Separates more amount to blood cell count: -But because and it is for volume cautions must have full intent to have accurate health history

Double RBC Pheresis

FDA in the 1990s used for this proceedure and finalizied it in 2001. Must be done in Whole Blood

• Hemogloblin must be with the acceptable blood for the procedure "If saline infusion volume, then":
• Males need to weihgh 130 pounds and be 5'1 tall or better if female, 190 pounds on the 5'5 tall"
• 16 week span for double RBCS
• -The red cell must not be around 300ML or Better if is must wait about 8-16 weeks of getting a full transfusion to avoid the transfusion from hurting the transfusion from not being in the proper state

Whole Blood Collection

• Must be registered in order to proceed.
  • Trained personnel only perform the procedures Whole blood collection personnel must be checked on- their names with I.D/ and numbers must match - If need to add then can add label on blood bags as needed.
    • Aseptic method also is vital- to only use approved Fda techniques -Tourniquet and pressure to confirm vein
    • The pressure must be above 4cm to where the needle starts at if not proper sterile conditions then needs to be reported as well again for second try

(

• To stop any bleeding) Raise the donor's legs and check their signs vital
  • Then assist patient The donor can be administered to the patient to re-oxygenate their body

Donor reactions

if does start vomiting: Instructions:

• Instruct patient what is to start breathing a bit more normal
• Use cold compress and pressure to their head
• If need is give water after vomiting has ceased
• Donor must ask for permission to start the procedure and must notify blood bank the patient's history To prevent injury to the patient it can be to stop the cardiac from having difficulty In addition to needing CPR

Donor Records

• Mandated in FDA; AABB
  • Records kept, and not to be changed/tampered with,
  • Policy needs to be with the standards Minimum for retention: 5-10 + years
• If not compatible then patient need to have proper steps to check everything

3 things on test perform:

• Abo/ Rh -Anti-Bodies Screen

• HBsAg

• To see that testing is complete to avoid testing in high areas

Abbreviated to be at 3"C, as it's more closer to a normal body temperates

• After 11th birthday need to keep donor with that donor after positive HBSAG, and that is with acute-Chronic
  • All things must kept accurate to what standards call If it's not approved or complete then it should be with drawn at that point and removed to where has had it's area/ or contact

Platelet Concentration Process

• Platelet concentrations do the routine with converted with blood or -By apheresis.

Platelethressis are to protect patients that are below: 50.000 u/l

• "Pedi-Pak will require to use that which in be done and or to have sterile and secure syringe for patients"