1) What test CAN be done to test for WNV?

2) Has WNV been transmitted by transplantation?

1) WNV NAT

2) yes organ and blood

Departure is when it is intended change (lack of reagent so use different one).

Deviation is an event that is inconsistent with applicable regulations, standards, or is unexpected or unforseeable.

1) Cornea I.D. # affixed to container that relates to all records

2) Statement if decided donor is eligible or ineligible

3) Summary of Records: a)statement that tests were done in CLIA and Center for Medicare and Medicaide Services b) Listing and interpretation of all tests for RCDAD  c)Name and address of place that did DED. d) if ineligible a statement why.

1) a) All results and interpretation of testing for RCDAD, name and address of testing laboratory

b) DED and person who determined it and the date

2) 10 year retention from latest date of distribution,disposition or expiration.

What must be on tissue that is used for transplant bc of Emergency/Urgent use, but does not have testing yet. 

"NOT EVALUATD FOR INFECTIOUS SUBSTANCES"

&

"WARNING: Advise patient of communicable disease risk"

Must complete DED and inform physician when get results - even after transplant

Identifying the donor (id code on container)

Statement that DED is not complete

Statement that HCT/P must not be transplanted until DED complete except urgent med needs (allograft, repro tissue, or death or serious morbiditity without HCT/P and no comparable tissue available).

a) Allograft/Autologous use

b) Reprodictive donated by sexually intimate partner of recipient

c) Cryopreserved tissue for repro use (other than embryos - which should be tested of semeen of oocytes)

a) DRA with:

i) NOK ii)member of househould iii)caretaker or friend iv)physician

b) Physical exam: if living only pertinent areas of concern

c) Records: 

i) lab tests (other than DED tests) - eg wbc

ii)Med records

ii) Coroner/autopsy

iv) any source pertaining to any RCDAD (police)

       - call police for records if incarceration unsure

1) notify consignee

2) submit to FDA deviation report within 45 days 

1) How many years back for men with men and what is 2

dx concerns?

2) IV drug use (non-med) in past _ years via _, _, and _. What are the 3 disease risks?

3)People received human-drvd clotting factors in _ years are at risk for 3 dx. If 1x for acute bleeding in last 12 months is it ok?

1) 5 years for men with men. Hep B and HIV

2) a) 5 yrs IV use b)SubQ, IM and IV. c) HIV, HepB, HepC

3) 5 years of clot factors. HepB & C, HIV. Ok if 1x event

1) Sex for $ or drugs how long back? Risk for?

2) Persons who had sex in past _ (yr/mos) with someone HIV+,HepB, active/symptomatic HepC are R/O.

3) Exposed to someone in past _ (yr/mos) to HIV,HBV, HCV blood through needle stick or contact of open wound, non-intact skin, mucous membrane.

1) 5 years. HepB,HepC,HIV

2) 12 months sex

3) 12 months

1) Children born to HIV+ mom, what criteria for R/O?

2) How long and what time of hx for incarceration R/O?

3) Does this include juvenile detention?

1) If <18mo or breast-fed in past 12 months is R/O

2) 72 consecutive hours in 12months

3) yes juvenile detention is also a R/O

1. All Testing for RCDAD
2. Name and Address of testing laboratory
3. DED
4. Date of DED
5. Person of DED

Yes

Need to include: Donor ID, Statement that DED is not complete, and Statement that must not be implanted until DED is complete

If in the past 8 weeks, then:

1)Must wait 21 days from vaccination to procure and that

being if the scab has fallen off spontaneously. 

2)If scab was removed intentionally, you must wait 2

months after vaccination.

3)If complications from vaccina then must wait 14 days

after vaccina complications are resolved.

-Do not defer if don't know the date.

4) If scab present defer

Defer for 120 days following onset or dx, by choosing the later one.

12 months.

If treated 12 months ago and resolved then can use

R/O should be considered for Dementia,

any degenerative or demyelinating dix of CNS

or other neuro dx unknown etiology?

What does non-synthetic dura mater and

human-pit growth hormone put you at risk for?

When could a donor have a blood relative with CJD but not be a R/O?

1. If the diagnosis was found incorrect
2. CJD was caused by med treatment
3. Lab testing can show donor does not have familial mutation assoc with CJD

When is a donor deferred for staying in UK.

How long (cumulative) and btwn what years?

3 months cumulative

between 1980-1996

1) Time and dates in all of Europe

2) People who received blood  in UK or France since...when until when?

1) 5 years cumulative btwn 1980 to present

2) 1980 to present

1) How long and what time frame for UK as r/o?

2) What time and how long for US military base...

a) Countries in north Europe & time frame there

b) Countries in south Europe & time frame there

1) UK from 1980 - 1996 for 3 months cumulative as residing/visiting

2) Military:

a) North: Germ, Belg, Neth for 6 mo from 1980-90

b) South: Portgl, Spain, Italy, Greece, Turky for 6 mo 1980-96

What is criteria for Africa:

1) born/lived or sex partner born/lived or received blood in what countries there and in what time.

2) what is risk for?

3)When do you not need to ask these questions?

1. 1977 in countries... Equat Guinea, Gabon, Niger, Nigeria, Cameroon, Central Africa, Chad, Congo, (4C, 2G, 2 N)
2. Risk for HIV-O
3. If you can test HIV-O ab in donor blood

Infusion of live cells and tissues that are from non-human source

Fluids, cells, tissues that had contact with live non-human cells or tissues

Intimate contact of person above (e.g. razor or even mucosal exchange by toothbrush, etc)

1. Postive or reactive previous Hep B or Hep C
2. Unexplained Jaundice
3. Past diagnosis of viral hep unless after 8 and identified as Hep A, EBV or CMV

Had or txted in past 12 months

Do not recommend deferral for donors treated more than 12 mo and evidence it was successful.

1. Eczema vaccinatum
2. rash
3. Progressive necrosis in area of vaccination
4. encephalitis postvaccine
5. vaccinial keratitis

If donor received how much fluid (?) should they be considered for plasma dilution and in what time frame?

Crystalloids? Colloids?

2000mls for all

colloid and blood in 48 hours

crystalloids in last hour

any blood or colloids in last 48 hours needs to be considered

Any crystalloids in last hour needs to be considered

Plasma dilution greater than _% is considered unrealiable?

If you have a body weight in 45-100kg you calculate blood and plasma volume by what calculations

blood?

plasma?

Blood

Kg/0.015 OR Kg x 70

Plasma

Kg/0.025 or Kg x 40

Protein or polysaccharide such as albumin, dextran or hetastarch used to increase osmotic pressure in intravasular compartment OR blood such as plasma and platelets

isotonic salt/glucose used for electrolyte replacement or to increase intravascular volume.

Such as Saline, Ringer lactate, D5W, or TPN

No

they are vaccinated

What are the five situations when you are not required to determine a donor eligibility?

1. Cells autologous use
2. Repro from sex intimate partner for repro purposes
3. Cryopreserved cells other than embryo

1. First degree or second-degree relative using it (aunts, unbles, nieces, nephews, first cousins, second-degree relatives)
2. urgent medical need and no other tisssued is comparable