Donor Selection (from Harmening [7th ed.] | F) Flashcards
True or False
The selection of potential blood donors has become more rigorous in the last 5 yrs w/ congent additions to the medical history questionnaire and serologic testing
True
True or False
The transfusion of blood to a pt in need is safer than it has ever been
True
Safety and therapeutic benefit are dependent on what?
Guidelines established by U.S. Food and Drug Administration (FDA) and AABB
What is done to the guidelines (established by U.S. FDA and AABB in terms of safety and therapeutic)?
These are carried out by the qualified and trained personnel in blood collection centers
Who are the organizations / associations who wrote the guidelines and regulations for donor selection and serologic testing?
1) FDA
2) AABB
While the purview of the 2 entities (/ guidelines and regulations [written by FDA and AABB]) may overlap in some areas of donor collection and donor testing, their institutional goals and national donation guidelines provide a what?
An effective framework of processes utilized by all blood donor centers across the U.S.
What is the meaning of CAP?
College of American Pathologists
What are the actions of CAP?
1) It conducts inspections of all clinical lab depts (including transfusion services, awarding accreditation to facilities that are deemed to be compliant w/ established stds)
2) It also provides a voluntary inspection and accreditation program (for its member institutions)
What is U.S. FDA?
It is a regulating agency
Where are the regulations (for donor screening) of U.S. FDA outlined?
These are outlined in the Code of Federal Regulations (CFR), Title 21, parts 211, 600-799
Blood is regarded as what (under the auspices of the FDA)?
It is regarded both as a biologic and a drug
What happened in 1988?
The Center for Biologics Evaluation and Research (CBER) was formed
What are the actions of CBER?
1) It is responsible for regulating the collection of blood and blood cmpts (used for transfusion and for the manufacture of pharmaceuticals derived from blood and blood cmpts )
2) It develops and enforces quality stds
3) It inspects blood establishments
4) It monitors reports errors, accidents, and adverse clinical events
What is the action of the FDA (in the early 1990s)?
It began to treat blood establishment the same as any drug manufacturer, requiring strict compliance w/ all aspects of transfusion medicine, including donor selection and screening
What are the other actions of FDA?
1) It establishes and maintains the regulations
2) It inspects blood collection and processing centers
3) It is also responsible for licensing:
a. Collection and processing facilities
b. Blood products and derivatives
c. Rgnts (used in the processing | and testing of these products)
4) It provides recommendations and requirements (regarding infectious diseases as well as potential emerging diseases)
What may be done by blood establishments?
They may adapt stricter requirements than those published by the FDA as written in the blood center’s standard operating procedure (SOP)
The AABB is formerly known as what?
American Association of Blood Banks
When is AABB established?
1947
What is AABB?
It is an international association of blood centers, transfusion and transplantation services, and individuals involved in transfusion medicine
What is the action of AABB?
It provides a voluntary inspection and accreditation program for its member institutions that meet the requirements of the Centers for Medicare and Medicaid Services (CMS) and the Clinical Laboratory Improvement Amendments of 1998 (CLIA)
What is the mission of AABB?
To establish and provide the highest std of care for pts and donors in all aspects of transfusion medicine
Did the AABB already published books on transfusion medicine throughout its existence?
Yes
What are the 2 resources w/c are vital to donor screening procedures?
1) AABB Standards for Blood Banks and Transfusion Services
2) AABB Technical Manual
What are discussed in the publications (/ books) published by the AABB?
The sp. guidelines for donor screening
Since most transfusion services are part of the clinical lab depts in a hospital, what is done to those services?
Those services are included in a CAP inspection
What are the states of CAP inspections (by CMS) as w/ the AABB inspections?
1) These are approved
2) These meet the CLIA requirements
What is donor selection (what does it encompass)?
1) Medical history requirements (for the donor)
2) Physical examination (partial)
3) Serologic testing of the donor blood
True or False
Any 1 of the areas (w/c are encompassed in donor selection) may preclude a potential donor from the donation process
True
What are the 2 questions w/c are designed to be answered by the medical history information and physical examination?
1) Will a donation of approximately 450 mL of whole blood be harmful to the donor?
2) Could blood drawn from this donor at this time potentially transmit a disease to the recipient?
As outlined in the AABB Standards, blood collection facilities must confirm what?
Donor identity
What should be done by blood collection facilities (as outlined in the AABB Standards)?
Link the donor to existing donor records
Most facilities (/ blood collection facilities) require a what (in terms of registration)?
A photographic identification
What are the different photographic identification w/c are required to be used by most blood collection facilities (in terms of registration)?
1) Driver’s license
2) Passport
3) School identification card
What must be done to prevent an ineligible donor from donating again (in relation w/ registration)?
Every donor must be checked against a permanent record of previously deferred donors
What are the list of info used by the collection facility in the registration process and is kept on record by use of a single record form or electronically?
1) Name (first, last, MI)
2) Date and time of donation
3) Address
4) Telephone
5) Gender (self-identified and self-reported regarding transgender donors)
6) Age or date of birth
What is the min. age (for a blood donor) for an allogeneic donation?
> or equal to 16 years (depending on individual state requirements)
Is there an upper age limit in terms of blood donation (for the blood donor)?
None
What is autologous donation?
Donating blood to be used for oneself
Is there an age restriction for autologous donation (for the blood donor)?
None
Since there is no age restriction for autologous donation (for the blood donor), what should be done?
Each donor-patient must be evaluated by the blood bank medical director
In terms of consent to donate, what are the things that should be done (for the blood donor)?
1) Donors should be informed of the procedure for donating blood and its potential risks
2) The donors must also be given educational materials informing them of the signs and symptoms associated w/:
a. Human immunodeficiency virus [HIV] infection
b. Acquired immunodeficiency virus (AIDS)
c. Behaviors that put them at high risk of infection
d. A caution not to donate blood (as a means of getting an HIV test)
At some point in the interview process, what must be done by the donors (in connection w/ consent to donate)?
They must sign a statement documenting that they have given consent to the donation
When must donors sign a statement (w/c documents that they have given consent to the donation | in connection w/ consent to donate)?
This is typically done at the end of the donor history questionnaire (DHQ)
What are the additional info that may be helpful in some cases?
1) The name of the pt for whome the blood is intended (directed donation)
2) Race of the donor for matching sp. phenotypes
3) Cytomegalovirus (CMV) status (some pt grps [such as neonates] require CMV-[-] blood in certain circumstances)
True or False
Obtaining an accurate medical history of the donor is non-essential
False, because obtaining an accurate medical history of the donor is essential
Why is obtaining an accurate medical history of the donor essential?
To ensure protection of the donor and benefit to the recipient
What was developed by a task force (that included representatives from the AABB, the FDA, and the blood and plasma industry | in terms of obtaining an accurate medical history of the donor)?
A standardized medical history questionnaire (/ donor history questionnaire [DHQ])
The questionnaire (/ standardized medical history questionnaire) was designed to be what?
To be self-administered by the donor
The questionnaire (/ standardized medical history questionnaire) was designed to be self-administered, bu if preferred, what may be done (in terms of its administration)?
It may be administered by a trained doctor historian
What must be done to self-administered questionnaires?
These must be reviewed by trained personnel before completing the screening process and prior to collecting blood
What should be the characteristic of the interviewer (in terms of obtaining the medical history of the donor)?
He/she should be familiar w/ the questions
Where should the interview (for obtaining the medical history of the donor) be done?
In a secluded area of the blood center or donor site
What are the characteristics of the questions (present in the questionnaire | for obtaining the medical history of the donor)?
1) These are designed
2) A simple yes or no can be answered and elaborated, if indicated
When should the medical history (/ obtaining of medical history of the donor) be conducted?
It should be conducted on the same day as the donation
What are the 3 types of deferral?
1) Temporary deferral
2) Indefinite deferral
3) Permanent deferral
What is temporary deferral?
The donor cannot donate for a specified time period
Provide an ex of the application of temporary deferral (/ its principle)?
The donor cannot donate for 2 wks from receipt of the polio vaccine
What is indefinite deferral?
The donor is prohibited from donating blood to another person for an unspecified period of time
What is permanent deferral?
The donor may never donate blood to another person
Can a donor also be deferred based on the mini-physical exam?
Yes, the donor may also be deferred
Provide an ex in what aspect can the donor be deferred based on the mini-physical exam?
Abnormal hgb value
What is the summary of DHQ questions (/ what are the questions [in summary] present in DHQ)?
1) Are you feeling healthy and well today?
2) Are you currently taking an antibiotic or taking any other medications for an infection?
3) Are you taking or have you ever taken any medications on the Medication Deferral List?
4) Have you read the educational materials?
5) In the past 48 hours, have you taken aspirin or anything with aspirin in it?
6) In the past 6 weeks, have you been pregnant or are you pregnant now?
7) In the past 8 weeks, have you donated blood, platelets, or plasma? In the past 16 weeks have you donated a double unit of red blood cells (RBCs) using an apheresis machine?
8) In the past 8 weeks, have you had any vaccinations or other shots? Have you had contact with someone who had a smallpox vaccination?
9) In the past 12 months have you had a blood transfusion; a transplant such as organ, tissue, or bone marrow; or a graft such as bone or skin?
10) In the past 12 months have you come in contact with someone else’s blood or had an accidental needle-stick injury? Had a tattoo? Had an ear or body piercing?
11) In the past 12 months, have you had sexual contact with anyone who has HIV/AIDS or has had a positive test for HIV/AIDS?
12) In the past 12 months, have you had sexual contact with a prostitute or anyone else who takes money or drugs or other payment for sex?
13) Male donors: Have you had sexual contact with another male in the past 12 months?
14) Female donors: Have you had sexual contact with a male who has ever had sexual contact with another male?
15) In the past 12 months, have you had sexual contact with a person who has hepatitis? Have you lived with a person who has hepatitis?
16) In the past 12 months, have you been treated for syphilis or gonorrhea?
17) Have you been in juvenile detention, lockup, or prison for more than 72 hours?
18) In the past 3 years, have you been outside of the United States or Canada?
a. Malaria
b. CJD and vCJD
c. Leishmaniasis
d. Received a blood transfusion in the UK or France
19) Have you ever had a positive test for HIV/AIDS virus?
20) Have you ever used needles to take drugs, steroids, or anything not prescribed by your doctor?
21) Have you ever used clotting factor concentrates?
22) Have you ever had hepatitis?
23) Have you ever Chagas disease? Had babesiosis?
24) Have you ever received a dura mater (or brain covering) graft?
25) Have you ever had any type of cancer, including leukemia?
26) Have you ever had any problems with your heart and lungs?
27) Have you ever had a bleeding condition or a blood disease?
28) Have you ever been in Africa?
29) Have you ever had sexual contact with anyone who has born or has lived in Africa?
30) Have any of your relatives had Creutzfeldt-Jakob disease (CJD)?
31) Have you ever received xenotransplantation?
Where can more info regarding the questionnaire (/ DHQ questions) and interpretation of the questions be read / accessed?
1) AABB Technical Manual
2) FDA website
Donors should appear what (in relation w/ the DHQ question “are you feeling healthy and well today?”)?
Donors should appear to be in good health w/out obvious signs or symptoms of:
1) Colds
2) Flu
3) Or other illness
Are donors who currently taking antibiotics for an infection or for prophylaxis after dental surgery deferred (in relation w/ the DHQ question “are you currently taking an antibiotic or taking any other medications for an infection?”)?
Yes, they may be deferred temporarily
Until when are the donors deferred if they are currently taking antibiotics for an infection or for prophylaxis after dental surgery (in relation w/ the DHQ question “are you currently taking an antibiotic or taking any other medications for an infection?”)?
Until the donor has completed the prescribed medication regimen and the infection has cleared up
Are donors who have taken tetracycline or other antibiotics used to treat acne acceptable for donation (in relation w/ the DHQ question “are you currently taking an antibiotic or taking any other medications for an infection?”)?
Yes
What must be done to all drugs and medications (in relation w/ the DHQ question “are you currently taking an antibiotic or taking any other medications for an infection?”)?
These must be cleared by the blood collection facility or blood bank medical director
What must be done by the investigator (during the process of obtaining the pt’s medical history) if the donor’s response to the question (“are you currently taking an antibiotic or taking any other medications for an infection?”) is yes?
He/she must investigate further
The Medication Deferral List was developed along w/ what? (in relation w/ the DHQ question “are you taking or have you ever taken any medications on the Medication Deferral List?”)
DHQ
True or False
The Medication Deferral List is not recommended to be used in conjunction w/ the DHQ (in relation w/ the DHQ question “are you taking or have you ever taken any medications on the Medication Deferral List?”)
False, because the Medication Deferral List is recommended to be used in conjunction w/ the DHQ
Where can the Medication Deferral List along w/ other donor history documents be found (in relation w/ the DHQ question “are you taking or have you ever taken any medications on the Medication Deferral List?”)?
On the FDA website
What is the responsibility of each facility’s medical director (in relation w/ the DHQ question “are you taking or have you ever taken any medications on the Medication Deferral List?”)?
He/she is responsible for determining if any other medications require a deferral
Most centers have what (in relation w/ the DHQ question “are you taking or have you ever taken any medications on the Medication Deferral List?”)?
A predetermined list of medications and their deferral requirements
What must be done to the prospective donors (prior ro beginning the DHQ | in relation w/ the DHQ question “have you read the educational materials?”)
They must be provided info (about the collection procedure and many risks involved)
How must the prospective donors be informed (in relation w/ the DHQ question “have you read the educational materials?”)?
They must be informed in a language they can understand
The prospective donors must also be informed about what (in relation w/ the DHQ question “have you read the educational materials?”)?
About high-risk behavior related to the AIDS virus
The prospective donors must be given what (in relation w/ the DHQ question “have you read the educational materials?”)?
They must be given the opportunity to ask questions regarding any aspect of the collection procedure
True or False
The donor does not need to acknowledge that he/she has read and understands all of the material (in relation w/ the DHQ question “have you read the educational materials?”)
False, because the donor needs to acknowledge that he/she has read and understands all of the material
How can the donor acknowledge that he/she has read and understand all of the material (in relation w/ the DHQ question “have you read the educational materials?”)?
This is generally done by having the donor sign a statement (indicating that they have read and understand the materials, have answered the health history questions honestly, have been informed of the risks of donation, and give their consent to the donation)
Who are the donors who may not be a suitable donor for PLT apheresis (in relation w/ the DHQ question “in the past 48 hours, have you taken aspirin or anything with aspirin in it?”)
1) Donors who have taken piroxicam
2) Donors who have taken aspirin
3) Donors who have taken anything w/ aspirin in it
* all within 3 days of donation
Why are donors who have taken piroxicam, aspirin, or anything w/ aspirin in it (within 3 days of donation) may not be suitable for PLT apheresis (in relation w/ the DHQ question “in the past 48 hours, have you taken aspirin or anything with aspirin in it?”)?
Because these medications inhibit PLT fxn
Is there a restriction for whole blood (WB) donation (in relation w/ the DHQ question “in the past 48 hours, have you taken aspirin or anything with aspirin in it?”)?
None
What may be preped if WB is collected (in relation w/ the DHQ question “in the past 48 hours, have you taken aspirin or anything with aspirin in it?”)?
Random donor PLTs
Can random donor PLTs be used as a sole source of PLTs (if the donor answered yes to this question “in the past 48 hours, have you taken aspirin or anything with aspirin in it?”)?
No, it may not be used as a sole source of PLTs
What is the deferral time for female donors (if the donor have been pregnant | in relation w/ the DHQ question “in the past 6 weeks, have you been pregnant or are you pregnant now?”)?
Temporary deferral (6 wks)
If complications are anticipated at delivery, what can be made by the blood bank medical director (for an autologous donation | (in relation w/ the DHQ question “in the past 6 weeks, have you been pregnant or are you pregnant now?”)?
Exceptions can be made
Is a first-trimester or second-trimester abortion or miscarriage a cause for deferral (in relation w/ the DHQ question “in the past 6 weeks, have you been pregnant or are you pregnant now?”)?
No
What is the deferral time if the woman received a transfusion during her pregnancy (in relation w/ the DHQ question “in the past 6 weeks, have you been pregnant or are you pregnant now?”)?
12 mos
What is the time interval between allogeneic WB donations (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
8 weeks or 56 days
How many hrs must pass prior to donating WB if the prospective donor has participated in an apheresis donation (PLTs, leukocytes, / granulocytes | in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
At least 48 hrs
The FDA limits PLT apheresis procedures to no more than what in a calendar yr (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
24
The FDA limits PLT apheresis procedures to no more than 24 in a calendar yr unless what (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
Unless approved by the blood bank (BB) medical director
How many times may an apheresis donor donate in a period of 7 days for a double or triple apheresis donation (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
Twice
How many times may an apheresis donor donate in 7 days for a double or triple apheresis donation (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
Once
What is the deferral time required by infrequent plasma apheresis (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
4 wks
What is an infrequent plasma apheresis (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
It can be defined as undergoing the procedure no more frequently than once every 4 wks
What is serial plasma apheresis program (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
It is structured so that the donor undergoes the procedure more frequently than once every 4 wks
What is the deferral time for a double RBC apheresis donation (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
16 wks
Why is the deferral time for a double RBC apheresis donation 16 wks (in relation w/ the DHQ question “in the past 8 weeks, have you donated blood, platelets, or plasma? in the past 16 weeks have you donated a double unit of red blood cells [RBCs] using an apheresis machine”)?
Due to the additional volume of RBCs that are donated
What is the deferral time if a potential donor has received a live attenuated or bacterial vaccine (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
2 wks
What are the live attenuated or bacterial vaccines that can be received by a potential donor resulting to a 2-week deferral (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
1) Measles (rubeola)
2) Mumps
3) Oral polio
4) Typhoid
5) Yellow fever
What is the deferral time if the donor has received a live attenuated vaccine for German measles (rubella) or chickenpox (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
4 wks
There is no deferral if the donor received what vaccines (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
Toxoids or killed or synthetic viral, bacterial, or rickettsial vaccines such as:
1) Diphtheria
2) Hepatitis A
3) Hepatitis B
4) Influenza
5) Lyme disease
6) Pneumococcal polysaccharide
7) Polio injection (Salk)
8) Anthrax
9) Cholera
10) Pertussis
11) Plague
12) Paratyphoid
13) Rabies
14) Rocky Mountain spotted fever
15) Tetanus
16) Typhoid injection (if the donor is symptom-free and afebrile)
What is the deferral time if donor received smallpox vaccination (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
14 - 21 days or until the scab has fallen off
Are donors who have been in close contact w/ someone who has recently vaccinated (w/ smallpox) at risk of possible infection as well (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
Yes
Accdg to FDA, is close contact (to the vaccination site) considered as a form of exposure (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
Yes
How is close contact (in relation w/ smallpox vaccination) done (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
Exposure to:
1) Vaccination site
2) Bandages
3) Clothing
4) Towels
5) Bedding (that have been in contact w/ the vaccination site)
What is the additional question that could be posed to the prospective donor (in relation w/ smallpox | in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
“If you have had the smallpox vaccine, has the scab fallen off by itself?”
Does the recipients who have received smallpox vaccine need to be quarantined (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
No
Why are the recipients who have received smallpox vaccine does not need to be quarantined (in relation w/ the DHQ question “in the past 8 weeks, have you had any vaccinations or other shots? have you had contact with someone who had a smallpox vaccination”)?
Because the vaccinia virus is inactivated in the manufacturing process
Who are the individuals who are known to be possible sources of bloodborne pathogens (in relation w/ the DHQ question “in the past 12 months have you had a blood transfusion; a transplant such as organ, tissue, or bone marrow; or a graft such as bone or skin?”)?
Donors who during the preceding 12 mos have received a transfusion of:
1) Blood
2) Or blood cmpts
3) Or other human tissues
a. Organ
b. Tissue
c. Bone marrow transplannt
d. Bone
e. Skin graft
What is the deferral time for donors who during the preceding 12 mos have received a transfusion of blood or its components or other human tissues (in relation w/ the DHQ question “in the past 12 months have you had a blood transfusion; a transplant such as organ, tissue, or bone marrow; or a graft such as bone or skin?”)?
12 mos (from the time of receiving the blood product / graft)
What is the deferral time if the donor (in the past 12 mos) had come in contact with someone else’s blood od had an accidental needle-stick injury, had a tattoo, / had an ear or body piercing (in relation w/ the DHQ question “in the past 12 months have you come in contact with someone else’s blood od had an accidental needle-stick injury? had a tattoo? had an ear or body piercing?”)?
12 mos
Why are donors (in the past 12 mos) who had come in contact w/ someone else’s blood or had an accidental needle-stick injury, had a tattoo, or had an ear or body piercing deferred for 12 mos (in relation w/ the DHQ question “in the past 12 months have you come in contact with someone else’s blood od had an accidental needle-stick injury? had a tattoo? had an ear or body piercing?”)?
Due to potential exposure to substances known to be sources of bloodborne pathogens
When is exposure assumed (in relation w/ the DHQ question “in the past 12 months have you come in contact with someone else’s blood od had an accidental needle-stick injury? had a tattoo? had an ear or body piercing?”)?
If the blood came in contact w/ an open wound / any nonintact skin / mucous membranes (such as nose, mouth, and eyes)
What are also considered as causes of deferral (and provide exs | in relation w/ the DHQ question “in the past 12 months have you come in contact with someone else’s blood od had an accidental needle-stick injury? had a tattoo? had an ear or body piercing?”)?
Skin penetrating injuries from instruments, equipment, needles, and so forth that are nonsterile and contaminated w/ blood or body fluids other than the donor’s own
Includes tattoos, permanent makeup, and ear and body piercings (unless applied by a state-regulated organization where sterile needles and ink are not reused)
What is the deferral time if the donor had sexual contact w/ anyone who has HIV/AIDS or has had a (+) test for HIV/AIDS (in relation w/ the DHQ question “in the past 12 months have you had sexual contact with anyone who has HIV/AIDS or has had a positive test for HIV/AIDS?”)?
12 mos (from the time of sexual contact w/ a person w/ clinical or lab evidence of HIV infection or who is at high risk for infection)
What is the deferral time if the donor had sexual contact w/ a prostitute or anyone else who takes money or drugs or other payment for sex (in relation w/ the DHQ question “in the past 12 months have you had sexual contact with a prostitute or anyone else who takes money or drugs or other payment for sex?”)?
12 mos (from the time of sexual contact)
What is the deferral time (as mandated by the FDA) if the donor had sex w/ any person who is a past / present IV drug user (in relation w/ the DHQ question “in the past 12 months have you had sex with anyone who has ever used a needle to take drugs or steroids or anything not prescribed by their doctor? in the past 12 months, have you ever had sex with anyone who has hemophilia or has used clotting factor concentrates?”)?
12 mos
What is the deferral time if the donor had sex w/ any person w/ hemophilia or a related blood disorder who has received factor concentrates (in relation w/ the DHQ question “in the past 12 months have you had sex with anyone who has ever used a needle to take drugs or steroids or anything not prescribed by their doctor? in the past 12 months, have you ever had sex with anyone who has hemophilia or has used clotting factor concentrates?”)?
12 mos
What is the meaning of MSM (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
Gay, Bisexual and Other Men who have Sex with Men
Can males who had sex w/ another male (MSM) may donate WB (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
Yes
When does males who had sex w/ another male (MSM) may donate WB (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
1) If they meet all other donor eligibility requirements
2) If have not had sex w/ another male in the past 1 yr
What happened in 1985 (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
The FDA began instituting an indefinite deferral for MSM since 1977, even if the sexual contact only happened once, to safeguard the public from transfusion-transmitted HIV (TT-HIV)
W/ more sensitive testing protocols and viral inactivation measures, what did the Department of Health and Human Services done (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
They initiated public discussion toward a revision of policy
What are the multiple factors involved in the revision of policy (initiated by the Department of Health and Human Services | in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
1) Operational assessment
2) DHQ studies
3) The Retrovirus Epidemiology Donor Study II (REDS II)
4) REDS III
5) Supportive data from other countries
What is the result of doing operational assessment (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
It was determined that quarantine release errors involving HIV contributed minimally to the risk of TT-HIV
The quarantine release errors involving HIV (w/c contributed minimally to the risk of TT-HIV is largely due to what | in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
Has been largely due to computerized inventory management in w/c a barcode reader is utilized to identify quarantined units
Who are the participants in a DHQ study that was conducted in 2011 (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
Donors who had sex w/ the opposite sex and MSM were interviewed
What was found in the DHQ study that was conducted in 2011 (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
It was found that answering questions related to sexual behavior was more effective when they approached the question from the standpoint of their blood being safe
What does the participants recommend (in the DHQ study that was conducted in 2011 | in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
1) They also recommended shorter donor educational materials
2) They also recommended the option to answer the question w/ “I don’t know”
What are the 4 viral markers that are evaluated in the REDS II study (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
1) Hepatitis B virus (HBV)
2) Hepatitis C virus (HCV)
3) Human immunodeficiency virus (HIV)
4) Human T-cell lymphotropic virus I and II (HTLV-I and II)
The 4 viral markers that are evaluated by / in the REDS II study in the context of behavioral risk factors are associated w/ what (in relation w/ the DHQ question “have you had sexual contact with another male in the past 12 months [for male donors]?”)?
Associated w/ donations that were (+) for 1 or more of the viruses
What is the key finding of the pilot study (REDS II study)?
For each viral infection, the behavioral risk factor was aligned to the epidemiology for each infection validating the current donor deferral criteria
According to the pilot study (REDS II study), a donor that had sex w/ an HIV-(+) partner was associated w/ how many folds of increase in risk of being HIV (+)?
132-fold increase
According to the pilot study (REDS II study), a history of MSM contact was associated w/ how many folds of increase in risk of becoming HIV (+)?
62-fold increase
Who are the participants in the REDS III study conducted?
MSM community
How are data gathered from the participants in the REDS III study?
Through surveys (that were web based)
How many percent of the MSM (in the REDS III study) thought that the donation deferral should change?
90%
How many percent of MSM (in the REDS III study) said that they would comply w/ the change to a 1 yr deferral?
59%
True or False
Some participants (in the REDS III study) thought the policy was discriminatory toward MSM
True
How many percent is the prevalence of HIV infection in MSM (in the REDS III study) who classified themselves as blood donors?
0.25%
In the REDS III study, are countries such as Australia also had a volunteer blood donor program and an MSM population were analyzed?
True
What is the change of deferral that happened in Australia (in connection w/ male donors who had sexual contact with another male in the past 12 months)?
From lifetime deferral to 1 yr deferral
What is the result of change in deferral in Australia (in connection if a male donor had sex w/ another male in the past 12 mos)?
Resulting in no change in risk to their blood supply 5 yrs before the change and 5 yrs after the change in policy
What are the other countries that have adopted a 1 yr deferral policy (in connection if a male donor had sex w/ another male in the past 12 mos)?
1) Argentina
2) Brazil
3) Hungary
4) Japan
5) Sweden
6) UK
What is the most effective way to do in aligning w/ current serologic testing and epidemiology of the HIV virus?
The decision to adopt a time-based deferral policy since last sexual encounter involving MSM
Did the 1977 benchmark had become less effective over time (in connection if a male donor had sex w/ another male in the past 12 mos)?
Yes
What is the option that was done (since the 1977 benchmark had become less effective over time)?
Eliminate all HIV-related deferrals and rely just on current testing
Is the option done in replacement w/ the 1977 benchmark accepted or rejected?
Rejected
Why is the option that replaced 1977 benchmark rejected?
Because of possible new cases of HIV that may go undetected
What is the deferral time for women who have had sex w/ an MSM in the past 12 mos (in relation w/ the DHQ question “have you had sexual contact with a male who has ever had sexual contact with another male?” (for female donors)?)?
12 mos
What is the deferral time if the donor had sexual contact / living w/ a person (close contact) who has acute / chronic hepatitis B (test [+] for HBsAg / HIV) or who has symptomatic hepatitis C or other hepatitis virus (in relation w/ the DHQ question “in the past 12 months, have you had sexual contact with a person who has hepatitis? have you lived with a person who has hepatitis?”)?
12 mos (following discontinuation of being in close contact)
What is the deferral time for prospective donors w/ a history of syphilis or gonorrhea or treatment for either, a reactive screening test for syphilis, or where no confirmatory test was performed (in relation w/ the DHQ question “in the past 12 months, have you been treated for syphilis or gonorrhea?”)?
12 mos (after completion of therapy)
What is the causative agent for syphilis (in relation w/ the DHQ question “in the past 12 months, have you been treated for syphilis or gonorrhea?”)?
Treponema pallidum
What are the characteristics of Treponema pallidum (in relation w/ the DHQ question “in the past 12 months, have you been treated for syphilis or gonorrhea?”)?
1) It may live for 1 - 5 days (in cold storage)
2) It thrives very well (in RT)
What is the effect of the characteristic of Treponema pallidum w/c it may live for 1 - 5 days in cold storage (in relation w/ the DHQ question “in the past 12 months, have you been treated for syphilis or gonorrhea?”)?
Only a fresh unit of RBCs may transmit infection
What is the effect of the characteristic of Treponema pallidum w/c that it thrives well in RT (in relation w/ the DHQ question “in the past 12 months, have you been treated for syphilis or gonorrhea?”)?
It places PLT concentrates above RBCs as potentially supporting transfusion-transmitted syphilis
How many cases of transfusion-transmitted syphilis have been documented as of today (in relation w/ the DHQ question “in the past 12 months, have you been treated for syphilis or gonorrhea?”)?
3
What must be done by donor centers in relation w/ T. pallidum (in relation w/ the DHQ question “in the past 12 months, have you been treated for syphilis or gonorrhea?”)?
They must use a screening test for T. pallidum (w/c should be / has been licensed by the FDA)
What is the deferral time if the donor had been in juvenile detention, lockup, or prison for 72 hrs > (in relation w/ the DHQ question “have you been in juvenile detention, lockup, or prison for more than 72 hours?”)?
12 mos (from the last date of incarceration)
What is the aim of this question (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
This question is general and is used to detect a donor who may have an increased risk of exposure to malaria, Creutzfeldt-Jakob disease or variant Creutzfeldt-Jakob disease (CJD or vCJD), and more recently, leishmaniasis
What is the deferral time for prospective donors who have been diagnosed w/ malaria (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
3 yrs (after becoming asymptomatic, irrespective of the receipt of antimalarial prophylaxis)
What is the deferral time for individuals who have lived 5 consecutive yrs > in countries considered malaria-endemic by the Malarial Branch, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
3 yrs (after departure from malaria-endemic countries)
What is the deferral time for individuals who have lived longer than 5 yrs in malaria-endemic countries and who have been a resident in nonendemic countries for < 3 consecutive yrs (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
3 yrs (after the 3-yr deferral period, the donor may be eligible to donate, provided the donor has been free from malaria during this period and meets all other donor eligibility criteria)
What is the deferral time for individuals who have traveled to an area where malaria is endemic (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
12 mos (after departure from the malaria-endemic area)
What is the deferral time if a prior resident of a malaria-endemic country returns to a malaria-endemic area after residence for 3 yrs consecutively in a nonendemic country (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
1 yr (from the time that they return to the nonendemic country)
What are CJD and vCJD (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
These are members of a grp of neurological disorders known as transmissible spongiform encephalopathies (TSE)
What is the other term for TSE (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Prion diseases
TSE affects what (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
1) Sheep
2) Cows
3) Humans
CJD results in what (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
1) Progressive dementia
2) Spongiform alterations in the brain (and is rapidly fatal)
CJD may be transmitted by what (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
1) Corneal transplants
2) Human dura mater grafts
3) Pituitary-derived human growth hormone
4) Neurosurgical instruments
Can humans also be infected by CJD (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Yes
How can humans be infected by CJD (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
By eating beef contaminated w/ prions, abnormal proteins found in the brain tissue of diseased cattle, w/c led to the term “mad cow disease”
What are the characteristics of prions (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Highly resistant to:
1) Heat
2) Ultraviolet (UV) light
What happens to bacteria and viruses when exposed to UV light (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
They are killed
What is the action of prions in TSE (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
They induce abnormal folding of normal proteins
What is the result of the action by prions in TSE (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
It leads to neurological symptoms and death
What happens to humans when they ingest contaminated beef from a diseased cow (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
They can develop vCJD
How many pts have been diagnosed w/ clinical vCJD as of 2015 (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
228
What are the countries involved w/ the cases of clinical vCJD as of 2015 (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
1) UK
2) U.S.
3) Canada
4) France
5) Austria
6) Belgium
7) Czech Republic
8) Denmark
9) Finland
10) Germany
11) Greece
12) Ireland
13) Italy
14) Liechtenstein
15) Luxembourg
16) The Netherlands
17) Poland
18) Portugal
19) Spain
20) Switzerland
21) Sweden
22) Israel
23) Japan
What is the deferral time for anyone diagnosed w/ CJD or vCJD or if the donor received a dura mater transplant or pituitary GH from a human cadaver (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Permanent deferral
What is the deferral time to anyone who is a blood relative of someone diagnosed w/ CJD or vCJD (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Indefinite deferral
What is the deferral time if the donor spent 3 or more mos in the UK from 1980 - 1996 and/or 5 yrs or more in France from 1980 to the present (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Indefinite deferral
What is the deferral time for persons who served in the U.S. military specifically for those who spent 6 mos or more in Northern Europe (Germany, UK, Belgium, and the Netherlands) from 1980 - 1990 or spent 6 mos or more from 1980 - 1996 in Greece, Turkey, Spain, Portugal, or Italy (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Indefinite deferral
What is the deferral time if a donor received a blood transfusion in the UK from 1980 to the present (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Indefinite deferral
What is the deferral time if the donor received bovine insulin since 1980 (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
Indefinite deferral (unless the bovine insulin did not come from the UK)
What are Leishmania spp. (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
These are intracellular protozoan parasites that cause leishmaniasis
Where are Leishmania spp. endemic (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
In tropical and subtropical areas such as:
1) Middle East
2) Mediterranean coast
3) Africa
4) Central and South America
5) Asia
How are Leishmania spp. transmitted (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
These are transmitted to humans (by the sand fly [Phlebotomus] infected w/ Leishmania
What are the clinical manifestations of Leishmaniasis (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
It ranges from cutaneous lesions to visceral infections (that may be fatal)
How many cases of transfusion-transmitted Leishmaniasis have been reported in the literature, primarily involving Leishmania donovani (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
15
What is the deferral time for people who are deployed of military and National Guard troops in Iraq in 2003 (in relation w/ the DHQ question “in the past 3 years, have you been outside of the United States or Canada?”)?
12 mos (from the date of departure from the area was instituted for any military personnel stationed in Iraq and any civilian and contract personnel who have visited the country)
What is the deferral time for those who have received a transfusion of blood, PLTs, plasma, cryoppt, or granulocytes in the UK or France since 1980 (in relation w/ the DHQ question “in the past 3 years, have you received a blood transfusion in the UK or France?”)?
Indefinite deferral
What is the deferral time for any person w/ clinical or lab dx of HIV infection (in relation w/ the DHQ question “have you ever had a positive test for HIV/AIDS virus?”)?
Indefinite deferral
What should be done to the donor’s arms (in relation w/ the DHQ question “have you ever used needles to take drugs, steroids, or anything not prescribed by your doctor?”)?
These should be checked for evidence of scars or punctures indicating self administration of self-injected drugs or for presence of any skin lesions in the venipuncture site
What is the deferral time for donors w/ evidence of past / present nonprescription drug use (in relation w/ the DHQ question “have you ever had a positive test for HIV/AIDS virus?”)?
Indefinite deferral
Should prospective donors w/ hemophilia or other bleeding disorders and who receive clotting factor concentrates be deferred from donating blood or cmpts (in relation w/ the DHQ question “have you ever used clotting factor concentrates?”)?
Yes (unless otherwise approved by the medical director because there is a high risk of bleeding following venipuncture)
What is the deferral time if there is a receipt of clotting factor concentrates, such as receipt of blood transfusions (in relation w/ the DHQ question “have you ever used clotting factor concentrates?”)?
12 mos
What is the deferral time for donors w/ a (+) test for HBsAg (in relation w/ the DHQ question “have you ever had hepatitis?”)?
Permanent deferral
What is the deferral time if a donor reacted positively for anti-HBc on more than 1 occasion (in relation w/ the DHQ question “have you ever had hepatitis?”)?
Indefinite deferral
What is the deferral time if donors had a (+) HBV nucleic acid testing (NAT) (in relation w/ the DHQ question “have you ever had hepatitis?”)?
Indefinite deferral
What is the deferral time if a donor has a clinical history / dx of viral hepatitis at age 11 or later (in relation w/ the DHQ question “have you ever had hepatitis?”)?
Permanent deferral
What is the deferral time if the donor was diagnosed w/ viral hepatitis before age 11 (in relation w/ the DHQ question “have you ever had hepatitis?”)?
Temporary deferral (blood and blood cmpts collected from the donor must not be used for further manufacture until the clinical circumstances are thoroughly reviewed by medical personnel)
What is the deferral time if the donor has a history of Chagas disease or babesiosis (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
Indefinite deferral
Chagas disease is also known as what (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
American trypanosomiasis
What is the causative agent for Chagas disease (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
Trypanosoma cruzi (a protozoan parasite)
What is the vector responsible for transmitting Trypanosoma cruzi (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
The hematophagous bug
To w/c family does the hematophagous bug belong (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
Reduvidae
How does transmission of hematophagous bug occur (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
When mucous membranes or breaks in the skin are contaminated w/ feces of infected hematophagous bugs
2) It may also be transmitted congenitally by:
a. Breastfeeding
b. Organ transplants
c. Blood transfusion
Where is Chagas disease endemic (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
In parts of Central and South America and Mexico
How many estimated number of persons are infected w/ Trypanosoma cruzi in the countries where Chagas disease is endemic (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
Estimated 11 M persons
How many persons approximately residing in the U.S. and Canada may be infected w/ Trypanosoma cruzi (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
Approx 300,000 persons
How many cases of transfusion-associated transmission of Chagas disease have been documented in the past 20 yrs (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
7 (all occurring in immunosuppressed recipients)
How many are known spp. of Babesia (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
70
How many spp. of Babesia are identified to infect humans (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
At least 5
What is the Babesia sp. that is capable to infect human (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
Babesia microti
How does Babesia microti infect humans (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
They utilize the vector Ixodes scapularis to infect the human and transmit the parasite
What is the mechanism of infection of Babesia microti, once it already infected a human (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
It penetrates the RBC where the trophozoite multiplies; upon lysis, the RBC merozoites are released into the blood where they are free to infect other RBCs
What is the incubation period for transfusion-associated infection w/ Babesia (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
2 - 8 wks
What are the symptoms for babesiosis due to Babesia microti (in relation w/ the DHQ question “have you ever had Chagas disease? had babesiosis?”)?
1) Malaise
2) Fatigue
3) Anorexia
4) Arthralgia
5) Nausea
6) Vomiting
7) Abdominal pain
8) Fever (reaching 40 DC)
What is the deferral time for prospective donors w/ a history of a dura mater graft (in relation w/ the DHQ question “have you ever received a dura mater (or brain covering) graft?”)?
Permanent deferral (due to an increased risk of exposure to CJD and vCJD)
What is the deferral time if the donor has a history of cancer, leukemia, or lymphoma (in relation w/ the DHQ question “have you ever had any type of cancer, including leukemia?”)?
Indefinite deferral
What should be done to any donor presenting w/ a history of cancer (in relation w/ the DHQ question “have you ever had any type of cancer, including leukemia?”)?
He/she should be evaluated by the BB medical director
What are the exceptions for deferral if the donor has a history of cancer, leukemia, or lymphoma (in relation w/ the DHQ question “have you ever had any type of cancer, including leukemia?”)?
1) Basal or squamous cell cancer
2) Carcinoma in situ of the cervix
3) Papillary thyroid carcinoma (w/c has been surgically removed)
Is it a cause for deferral if the donor has a history of cardiovascular, coronary, / rheumatic heart disease (in relation w/ the DHQ question “have you ever had any problems w/ your heart or lungs?”)?
Yes (usually)
When may the donor be accepted on a case-by-case basis by the BB medical director (in relation w/ the DHQ question “have you ever had any problems w/ your heart or lungs?”)?
If there is an absence of disability or restrictions by the pt’s physician
If the donor has active pulmonary TB / other active pulmonary disease, is it a cause for deferral (in relation w/ the DHQ question “have you ever had any problems w/ your heart or lungs?”)?
Yes
What must be done to donors indicating a history of a bleeding problem following surgery, invasive dental procedures, cuts, or abrasions (in relation w/ the DHQ question “have you ever had a bleeding condition or a blood disease?”)?
They must be further evaluated by the BB medical director
What can be the blood diseases and condition that the donor can have that is a cause for deferral (in relation w/ the DHQ question “have you ever had a bleeding condition or a blood disease?”)?
1) Hemophilia
2) von Willebrand disease (vWD)
3) Sickle cell anemia
4) Thalassemia
5) Kaposi’s sarcoma
6) Polycythemia
Or history of receiving clotting factor concentrates
What is the deferral time if the donor has blood disease/s or has a history of receiving clotting factor concentrates (in relation w/ the DHQ question “have you ever had a bleeding condition or a blood disease?”)?
Indefinite deferral
Where is HIV-1 grp O virus endemic (in relation w/ the DHQ question “have you ever been in Africa?”)?
In central and west regions of Africa
What is the deferral time if the donor who was born or lived in any of the African countries on the FDA list of countries w/ HIV-1 grp O risk since 1997 (in relation w/ the DHQ question “have you ever been in Africa?”)?
Indefinite deferral
What is the deferral time if the prospective donor has traveled to any of the countries on the FDA list since 1977 and received a blood transfusion or other medical treatment w/ a blood product
Indefinite deferral
What is the deferral time if the prospective donor indicates having had sex w/ a person who was born in any of the African countries targeted w/ increased risk of HIV-1 grp O infection (in relation w/ the DHQ question “have you ever had sexual contact with anyone who was born or has lived in Africa?”)?
Indefinite deferral
What can be done to the questions concerning residence in or travel to sp. African countries or sexual contact w/ persons from those countries if the collecting facility has implemented testing for HIV-1/2 or testing that has been licensed for use in detecting Abs to HIV-1 grp O (in relation w/ the DHQ question “have you ever had sexual contact with anyone who was born or has lived in Africa?”)?
These may be omitted
What can be done to donors who were previously deferred prior to the availability of the HIV-1 grp O testing (in relation w/ the DHQ question “have you ever had sexual contact with anyone who was born or has lived in Africa?”)?
They may be reentered provided that it has been at least 1 yr since the last potential exposure to HIV-1 grp O and the screening test results are nonreactive
What is the deferral time if the prospective donor has a family history of CJD (in relation w/ the DHQ question “have you ever have any of your relatives had Creutzfeldt -Jakob disease (CJD)?”)?
Indefinite deferral (as recommended by FDA; unless the dx of CJD was confidently excluded)
Can the donor (who was deferred due to family history of CJD) be reentered (in relation w/ the DHQ question “have you ever have any of your relatives had Creutzfeldt -Jakob disease (CJD)?”)?
Yes, if the dx of CJD in the family member/s is confidently excluded or CJD in the family member/s is iatrogenic, or if appropriate lab testing such as gene sequencing shows the donor does not have a mutation found in association w/ familial CJD
What is the deferral time if the donor received cells, tissues, / organs from a nonhuman animal source (in relation w/ the DHQ question “have you ever received a xenotransplantation?”)?
Permanent deferral
What are acceptable to be received by the donor (in relation w/ the DHQ question “have you ever received a xenotransplantation?”)?
Nonliving biologics / materials from nonhuman animals such as:
1) Porcine heart valves
2) Porcine insulin
What is done by the donor center representative (in terms of physical examination | or what are the parts of physical exam)?
He/she evaluates the prospective donor w/ regard to:
1) General appearance
2) Weight
3) Temp
4) Hgb
5) Presence of skin lesions
True or False
A BB physician should be available to evaluate any special considerations (w/ regards to physical exam)
True
What should the donor center representative do (in relation w/ physical exam, in terms of general appearance)?
He/she should observe the prospective donor for presence of:
1) Excessive anxiety
2) Drug or alcohol influence
3) Nervousness
How should observance of the prospective donor in terms of his/her general appearance (in relation w/ physical exam) be done?
This should be done by the donor center representative in a gentle manner (so as not to deter the donor from future donations)
What should be the weight of all donors (in connection w/ weight | in terms of physical exam)
At least 110 lbs
What is the max. weight of the donor (as mandated by Standards | in connection w/ weight | in relation w/ physical exam)?
Max. of 10.5 mL of blood/kg of donor weight (for WB collection), inclusive of pilot tubes for testing
What must be done if the donor weighs < 100 lbs (in connection w/ weight | in relation w/ physical exam)?
The amt of blood collected must be proportionately reduced as well as that of the anticoagulant
What are the formulas that can be used to calculate the adjusted volume of blood to be collected and anticoagulant (CPD and CPDA-1) to be used (in connection w/ weight | in relation w/ physical exam)?
1) Volume to collect = (donor’s weight in kg/50) X 450 mL
2) Volume to collect/450 X 63 mL = reduced volume of anticoagulant
3) 63 mL - above calculated volume = amount of solution to be removed
What must be the temp of the donor (in terms of temp | in relation w/ physical exam)?
It must be < or equal to 37.5 DC or 99.5 DF
What is asked to donors (in relation w/ temp | in relation w/ physical exam)?
They are asked not to drink coffee or hot beverages while waiting to donate
Why are donors asked not to drink coffee or hot beverages while waiting to donate (in connection w/ temp | in relation w/ physical exam)?
Because by doing so, it may sometimes affect their temp
What is the characteristic of oral temps (/ temps collected orally | in connection w/ temp | in relation w/ physical exam)?
These are lower > normal
Are oral temps a cause for deferral (in connection w/ temp | in relation w/ physical exam)?
No
What should be the hgb lvl and hct lvl of female donors (/ women) in allogeneic donations (in connection w/ hgb | in relation w/ physical exam)?
Hgb lvl: should be > or equal to 12.5 g/dL
Hct lvl: should be > or equal to 38%
What should be the hgb lvl and hct lvl of male donors (/ men) in allogeneic donations (in connection w/ hgb | in relation w/ physical exam)?
Hgb lvl: should be > or equal to 13.0 g/dL
Hct lvl: should be > or equal to 39%
What should be the hgb and hct lvl of the donor (in / for autologous donation | in relation w/ hgb | in relation w/ physical exam)?
Hgb lvl: should be > or equal to 11.0 g/dL
Hct lvl: should be > or equal to 33%
What are the methods used for measuring hgb (in connection w/ hgb | in connection w/ physical exam)?
1) Copper sulfate
2) Point-of-care instruments (using spectrophotometric methodology)
How can hct or packed cell volume (PCV) be determined (in relation w/ hgb | in relation w/ physical exam)?
It can be determined manually (via or by centrifugation)
Can the earlobe be used for hgb / hct determination (in relation w/ hgb | in relation w/ physical exam)?
No
What should be done to the donor’s arms prior to donation (in connection w/ skin lesions | in connection w/ physical exam)?
The donor’s arms should be inspected for skin lesions
Are evidence of skin lesions (such as multiple puncture marks) a cause for deferral (in connection w/ skin lesions | in connection w/ physical exam)?
Yes
What is the deferral time if the donor has evidence of skin lesions (such as multiple puncture marks | in connection w/ skin lesions | in connection w/ physical exam)?
Indefinite deferral
Are skin disorders (such as poison ivy and other rashes) a cause for deferral (in connection w/ skin lesions | in connection w/ physical exam)?
No
Since skin disorders (such as poison ivy and other rashes) are not a cause for deferral, is it okay for these to be present in the area of venipuncture site (in connection w/ skin lesions | in connection w/ physical exam)?
No
What should be done if skin disorders (such as poison ivy and other rashes) are present in the area of venipuncture (in connection w/ skin lesions | in connection w/ physical exam)?
These may be needed to be evaluated by a BB physician
What is mandated by the AABB Standards (in terms of informed consent)?
It mandates that informed consent of allogeneic, autologous, and apheresis donors be obtained before donation
What must be done to the donor (in terms of informed consent)?
The donor must be informed of the risks of the procedure and of the tests that are performed
Why must the donor be informed of the risks of the procedure and of the tests performed (in connection w/ informed consent)?
To reduce the risk of infectious disease transmission to the recipient
What must be done (/ what must be the capability) of the donor (in connection w/ informed consent)?
He/she must be able to ask questions concerning any element of the collection or testing process
True or False
If the donor is a minor / is unable to comprehend the informed consent protocol, applicable state law provisions will intercede
True
What is an autologous donor?
He/she is the one who donates blood for his/her own use, thus, he/she is referred to as the donor-patient
What is the use of most autologous blood?
It is used to treat surgical blood (in very sp. situations where there is a reasonable opportunity to avoid homologous transfusions / when compatible allogeneic blood is not available)
What is the potential advantage of using autologous blood over allogeneic blood?
There is a decreased risk of:
1) Disease transmission 2) Transfusion rxns 3) Alloimmunization
Even if there is a potential advantage of using autologous blood over allogeneic blood, what can still be present?
There is still a risk of:
1) Bacterial contamination 2) Circulatory overload 3) Cytokine-mediated rxns 4) Misidentification of the product / pt
Who are the pts whom autologous donation / transfusion holds the greatest advantage?
1) Those pts who have very rare blood types
2) Those pts w/ multiple Abs for w/c compatible units in the general blood supply may be difficult / impossible to find
What are the disadvantages of autologous donation / transfusion?
1) It has a higher cost (due to added administrative processes and special labeling requirements to ensure that units get transfused to the proper pt)
2) There is a high percentage of wasted units (30 - 50% | because pts end up not requiring any / all of the units donated)
3) The AABB Standards does not permit “crossing over” of unused autologous units into the general inventory (except in exceptional circumstances | the decision must be approved by the medical director on a case-by-case basis)
True or False
Although the use of autologous blood has decreased in the past several yrs, it is still viable and common alternative therapy for select pts
True
What are the various methods and techniques for obtaining autologous blood?
1) Preoperative collection
2) Acute normovolemic hemodilution
3) Intraoperative collection
4) Postoperative collection
Preoperative collection occurs when?
During 5 - 6 wks (immediately preceding a scheduled, elective surgical procedure unless the RBCs and plasma are scheduled to be frozen)
What are the procedures that typically might use preoperative autologous blood?
1) Orthopedic procedures
2) Vascular surgery
3) Cardiac or thoracic surgery
4) Radical prostatectomy
Although some women do participate in an autologous collection program during pregnancy for unforeseen complications, when is blood needed?
It is seldom needed except in cases in w/c the mother has multiple Abs to high-frequency Ags or risk for placenta previa or intrapartum hemorrhage
The decision to use preoperative autologous blood requires what?
It requires both:
1) An order (from the pt’s physician)
2) An approval (from the BB medical director)
What is the meaning of MSBOS?
Maximal surgical blood order schedule
What is the action of MSBOS?
It can provide guidance for surgical procedures to estimate the # of units needed for transfusion
When should the last blood collection (for preoperative collection) occur?
No later than 72 hrs (3 days) before the scheduled surgery
Why should the last blood collection (for preoperative collection) occur no later than 72 hrs / 3 days before the scheduled surgery?
To allow volume replacement
What are the characteristics of the medical history and physical exam requirements for autologous donation in comparison than those for allogeneic donations?
These are less stringent than those for allogeneic donations
In / for preoperative collection, is there a min. or max. age requirement for donors?
None
Even if in / for preoperative collection, there is no min. or max. age requirement, what must be the characteristic that the donor must have for the said procedure?
The donor must be able to tolerate the donation
Even if in / for preoperative collection, there is no min. or max. age requirement, what must be the characteristics that the donor must have for the said procedure (for younger donors)?
Most centers limit the age to children:
1) Whose veins can accommodate the phlebotomy needle
2) Who can understand the procedure
What is the min hgb lvl for preoperative collection?
11.0 g/dL
What is the min. hct level for preoperative collection?
33%
What should be the characteristic of the donor-pt’s temp (for preoperative collection)?
It should not be elevated / indicate any sign of possible infection
What should be the characteristic of the medical history questions for the donor (for preoperative collection)?
These can be limited to those needed to ensure the safety of the donor
What are the medical history questions that can be asked to the donor (for preoperative collection)?
1) Cardiac history
2) Bleeding disorders
3) Major illness
4) Previous donor rxns
5) Fainting problems
True or False
Questions to rule out the possibility of bacteremia in the donor-pt should be present (for preoperative collection)
True
What are the information included in the questions to rule out the possibility of bacteremia in the donor-pt (for preoperative collection)?
Info on:
1) Current medications
2) Antibiotics
3) Recent infections
4) Fever
5) Recent minor procedures
a. Dental procedures
6) GI problems
7) Diarrhea
What is the std for most autologous donor units (for preoperative collection)?
A std of 450 / 500 mL (+)(-) 10%
What must be done if the donor weighs < 50 kg (110 lbs) (for preoperative collection)?
The total amt of blood must be reduced proportionately
What must be done if the amt of blood to be collected is determined to be 300 - 405 mL for a 450 mL bag or 333 - 449 in a 500 mL bag (for preoperative collection)?
The unit must be labeled as low volume
Is there a requirement to reduce the volume of anticoagulant-preservative solution (for preoperative collection)?
None
Is plasma suitable for transfusion (for preoperative collection)?
No
What must be done if the unit must be < 300 mL (for preoperative collection)?
The anticoagulant-preservative solution must be adjusted and approval by the BB medical director is required
What is the characteristic of testing requirements for autologous donor units than w/ allogeneic units (for preoperative collection)?
These are somewhat less stringent than w/ allogeneic units
What must be done by the collecting facility (for preoperative collection)?
It must determine the ABO and Rh of the blood
Is Ab screen required to be done by the collecting facility (for preoperative collection)?
No, it is optional
Is viral marker testing required to be done (for preoperative collection)?
No, if the collecting and the transfusing facilities are the same
What must be done by the collecting facility if the collecting and transfusing facilities are different (for preoperative collection)?
The collecting facility must test for:
1) HBV DNA
2) HBsAg
3) Anti-HBc
4) Anti-HCV
5) HCV RNA
6) Anti-HIV-1/2
7) HIV-1 RNA
8) Anti-HTLV-I/II
9) WNV RNA
10) STS
In what unit should the tests be conducted by the collecting facility (if the collecting and transfusing facilities are different | for preoperative collection)?
On at least the 1st unit collected from the donor in every 30-day period
What must be done if any of the markers (whereas the tests are conducted by the collecting facility | w/c are conducted because the collecting and transfusing facilities are different | for preoperative collection) yield a (+) / reactive result?
The pt’s physician and transfusing facility must be notified of the result
What must be done by the transfusing facility (for preoperative collection)?
It must reconfirm the ABO and Rh of the unit, but a crossmatch is optional
What can be done as a good safety check for confirming that the selected unit is identified properly (in connection w/ the transfusing facility reconfirming the ABO and Rh of the unit | for preoperative collection)?
Immediate spin crossmatch
What must be done to units collected for autologous use (for preoperative collection)?
These must be labeled appropriately
What should be the cmpts of the label (for units collected for autologous use | for preoperative collection)?
1) Pt’s full name
2) Pt’s unique identifying number (UIN)
3) Expiration date of the unit
4) Name of the facility (where the donor-pt will be transfused)
What must the label (for units collected for autologous use) clearly state (for preoperative collection)?
“For Autologous Use Only”
True or False
Autologous units also generally have a distinct green label and tag (for preoperative collection)
True
Why is a distinct green label and tag generally present in autologous units (for preoperative collection)?
This is done both to ensure the unit is linked correctly w/ the donor-pt and to make the BB technologists aware that certain pts have autologous units on the shelf that must be transfused before allogeneic units (more specifically, the oldest units should be transfused 1st)
True or False
BBs should have a system in place to ensure autologous units are selected 1st (for preoperative collection)?
True
What is the meaning of ANH?
Acute normovolemic hemodilution
ANH results in what?
Collection of WB w/ the concurrent infusion of crystalloid / colloid solutions, thus maintaining a normal blood volume but decreasing the pt’s hct
What is the ratio of replacement for crystalloids (for ANH)?
3:1
What is the ratio of replacement for colloids (for ANH)?
1:1
The # of units collected (for ANH) depends on what?
The pts’s ability to tolerate the decrease in hgb / hct
What is the effect of a limited hemodilution (for ANH)?
It will reduce the hct to 28%
What is the effect of severe dilution (for ANH)?
It will reach 21% or less (hct)
What is recommended to be done for / by the pt (for ANH)?
It is recommended that the pt start w/ a hgb of at least 12.0 g/dL
When is ANH performed?
It is performed in surgery immediately prior to beginning the surgical procedure
Who manages the ANH procedure?
The anesthesiology
