What are the mandatory requirements for blood bank and transfusion centers
FDA
- Registration within 5 days
- Lincensure for across state shipment
- Biological Product Deviation (BPD) reports: must be reported. examples: Fatalities,wrong exiration date is wrong, something is outdated, not all testing completed
What are the voluntary regulations?
AABB
CAP
JCAHO
Who does the following?
- Voluntary inspection and accreditation program
- Sets standards of performance, standards for BB and Transfusion services
AABB
Who does the following?
- Inspects and accredits laboratories of health care facilities
CAP
Who does the following?
- Inspects hospitals
- Requires collection of data on processes related to the use, ordering and adminisration of blood products.
JCAHO
What are the 3 types of deferrals for donating blood?
Temporary
Indefinite
Permanent
Donor is unable to donate for a specified and limited period of time. What type of deferral is this?
Temporary
Donor is unable to donate for someone else for an unspecified period of time due to current regulatory requiremnts. They cannont donate until current policies change. They may be eligible to donate autologous blood. What type of deferral is this?
Indefinite
Donor will NEVER be eligible to donate blood for someone else. They may be able to donate autologous blood. What type of deferral is this?
Permanent
Deferral Period?
- Visited places in Africa where HIV, group O is prevalent
Indefinite if transfused or lived in or had sexual contact with someone from this area. UNLESS, testing facility performs licensed test for antibodies to HIV-1 group O.
Deferral Period?
- Was in Europe greater than 5 years cumulative since 1980
where vCJD is common.
Indefinite
Deferral Period?
Visited the UK for 3 mos. cumulative sometime between 1980 - 1996. Where vCJD was prevalent
Indefinite only if between 1980 and 1996
Deferral Period?
- Just got back from Iraq
The infectious agent of concern is: Leishmania
Temporary: 12 months from departure date
Traveled various regions of the world where SARS (Severe acute repiratory syndrome) is seen.days after return to the US
Temporary: 14 days after return to the U.S.
What are some examples of indefinite deferrals?
Viral Hepatitis after 11th birthday
History of babesiosis or Chagas' disease
any CJD or risk to CJD
What are some reasons for Permannet Deferral
Male to male sex since 1977
Family History of CJD
What are some reasons for 12 month deferrals for blood donars?
1.Recipient of a transfusion
2.transplants
3.possible exposure to blood
4.Sexual contact with someone who has HBV,HIV or viral
symptoms of hepatitis
5.Incarcerated for more than 72 hours
6.Hx of syphilis or gonorrhea
To donate blood what must your H&H AT LEAST be?
Hgb 12.5g/dL
Hct 38%
To donate blood what must your pulse be between?
50 - 100 beats per minute
To donate blood what must your BP be?
Systolic: no higher than 180mm Hg
Diastolic: no higher than 100mm Hg
To donate blood what must your Temperature be?
37.5oC
To donate blood what must your weight be?
Many blood centers state that the weight must be at least 110lbs.
AABB standard states that no more than 10.5mL/kg of donor weight can be collected.
What 10 infectious disease testing is performed on donated blood?