DONOR ELIGIBILITY EYE & TISSUE DREW TIMMONS, RN, CTBS TRANSPLANT SERVICES CENTER UT SOUTHWESTERN MEDICAL CENTER

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1 DONOR ELIGIBILITY EYE & TISSUE DREW TIMMONS, RN, CTBS TRANSPLANT SERVICES CENTER UT SOUTHWESTERN MEDICAL CENTER

2 FACTORS IMPACTING EYE & TISSUE DONOR EVALUATION Institution Policy Clinical Experience Training Personal Bias FDA Guidelines

3 ALL REFERENCES ARE FROM: Food and Drug Administration s Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps)

4 CASE ONE HOSPITAL REFERRAL - ER 47 year old Male Called 911 and said he couldn't breathe--ems to ER...apneic and CPR and ACLS done for 30 min; family requested to stop interventions. PMH-Pt had a nerve procedure in his back done a week previously No lab, no CXR IVF: 1000ml NS, no blood given Kilogram 72 inches tall Registered Donor

5 CASE ONE UDRAI RESULTS Fever - Past couple of weeks looked as if he was fighting a cold no treatment sought Cough - Past couple of weeks looked as if he was fighting a cold no treatment sought Swollen Lymph notes - Past couple of weeks in neck and groin Weight loss - 30 pounds over three months, unknown reason Sores on mouth yesterday looked like fever blister or cold sore

6 CASE ONE UDRAI RESULTS 21. Did she/he* EVER use or take drugs, such as steroids, cocaine, heroin, amphetamines, or anything NOT prescribed by her/his* doctor? Yes 21a. What was it? HGH 21b. How often and how long was it used? 2 rounds in the last 5 years 21c. When was it last used? d. Were needles used? Yes 28. Did she/he* EVER use or take growth hormone? Yes 28a. When was it used? b. What kind was it? Human Growth Hormone

7 IS THIS AN APPROPRIATE DONOR?

8 CASE ONE - PROCESSOR WANTED MORE INFORMATION Discussed "Yes" answers with NOK; this week he felt feverish, with congestion and swollen lymph nodes the "fever blisters" broke out yesterday, the NOK states this is a normal response to fever for him in regards to the HGH use, NOK "thinks" it was prescribed by a friend who might be an MD but can't provide any contact information; in addition he was currently taking other "vitamins" via syringes to the stomach, again, no MD information; NOK describes the deceased as being very secretive about what he was taking weight loss began as the two of them separated with divorce proceedings begun

9 IS THIS AN APPROPRIATE DONOR?

10 OUR RESPONSE - DEFERRED Infection was a concern given signs and symptoms IV.DONOR SCREENING ( ).E.2. Persons who have injected drugs for a non-medical reason in the preceding 5 years, including intravenous, intramuscular, or subcutaneous injections (Refs. 18, 21, 22, 25, 27, 29, 33, 34, 36, 38, 42, and 45 through 59) (risk factor HIV, Hepatitis B and Hepatitis C).

11 CASE TWO HOSPITAL REFERRAL MED/SURG 49 year old female Admitted 3 days previously: c/o numbness in hands, lips, head then unresponsive with snoring respirations. EMS. Aspirated. ER. Intubated. Probable seizure. Past Medical History: CVA 3 weeks ago, HTN, High Cholesterol, Toothaches occasionally, C-Section Registered Donor

12 CASE TWO MEDICAL/SOCIAL QUESTIONNAIRE Night Sweats in last 2 weeks Meds for HTN & Cholesterol 1 pack a day smoker since age 13 Beer 3 per day during week, 6 per day weekend Close contact with sister who had Hep C Crack cocaine/ Cocaine every week with last being before CVA (no IV use) Marijuana at least once a month with last being before CVA

13 CASE TWO FOLLOW UP DURING INTERVIEW Deceased s Sister died 6 weeks ago They shared drinking glasses and joints Deceased assisted sister with dressing changes for sister s wound No contact with bodily fluids Hep C was not active

14 OUR RESPONSE - ACCEPTED IV.DONOR SCREENING ( ) E.9. Persons who have lived with (resided in the same dwelling) another person who has hepatitis B or clinically active (symptomatic) hepatitis C infection in the preceding 12 months (Ref. 69).

15 HIGH RISK? CASE THREE Medical Examiner Referral: 16 y.o. male; GSW to the head Apparent drive by shooting while deceased was sitting in a car in front of a convenience store located in a lower-socioeconomic area of a major city Details sparse on initial investigative report but mother reports no drug or alcohol use

16 HIGH RISK? CASE THREE UPDATE A search of the local newspaper s online edition showed an article had been posted about the shooting; The article mentioned the large number of shootings at that location since the store was on the border between two rival gangs; the article also commented it was a site for drug exchanges.

17 HIGH RISK? CASE THREE UPDATE Updated Medical Examiner Investigator report received which contained more information from the on-site investigation: the vehicle in which the decedent was sitting contained drugs and drug paraphernalia to include syringes Physical examination noted non-professional tattoos with gang-related themes

18 OUR RESPONSE - DEFERRED Minimum Legal Age for Tattoo in Texas is 18 years old IV.DONOR SCREENING ( ) E.10. Persons who have undergone tattooing, ear piercing or body piercing in the preceding 12 months, in which sterile procedures were not used, e.g., contaminated instruments and/or ink were used, or shared instruments that had not been sterilized between uses were used (Ref. 69). IV.DONOR SCREENING ( ) E. 2.Persons who have injected drugs for a non-medical reason in the preceding 5 years, including intravenous, intramuscular, or subcutaneous injections (Refs. 18, 21, 22, 25, 27, 29, 33, 34, 36, 38, 42, and 45 through 59) (risk factor HIV, Hepatitis B and Hepatitis C).

19 HIGH RISK? CASE FOUR Medical Examiner Referral: 26 y.o. male; GSW to the head Apparent drive by shooting while deceased was shopping in a convenience store located in a lowersocioeconomic area of a major city Details sparse on initial investigative report but Next-of-Kin reports no drug or alcohol use

20 HIGH RISK? CASE FOUR UPDATE A search of the local newspaper s online edition showed an article had been posted about the shooting; it appeared the shooting was random; deceased was not visible from the street; article went on to discuss the deceased s lifestyle: hard worker, active in church, known for his humor and helpfulness

21 HIGH RISK? CASE FOUR UPDATE Updated Medical Examiner Investigator report received which contained more information which indicated no high-risk behavior; investigators describe shooting as random with no specific target

22 OUR RESPONSE - ACCEPTED No concerns about high risk behavior

23 HIGH RISK? CASE FIVE Hospital Referral - ER 34 year old male; witnessed cardiac arrest at local Gentlemen's club; coded for 30 minutes No lab, no CXR IVF: 500 ml NS, no blood given 85 Kilograms 70 inches tall Registered Donor

24 HIGH RISK? CASE FIVE UPDATE Was initially ruled out for high risk but this was reversed pending further review Medical Examiner Investigator report revealed deceased was an employee (business manager) of the club with coworkers describing him as hard working and denied any high risk behavior Next-of-Kin was the wife who denied any high-risk behavior

25 OUR RESPONSE - ACCEPTED No concerns about high risk behavior

26 HIGH RISK? CASE SIX Hospital Referral - ER 66 year old male Was driving at airport when his vehicle hit a wall; he was found unresponsive behind the wheel, it is suspected cardiac event led to crash EMS found in asystole, no response to ACLS meds noted by EMS or ER staff Past medical history: HTN, cirrhosis RN reported he was wearing a ladies garter belt and hose under his pants

27 HIGH RISK? CASE SIX UPDATE RN was present while NOK was being interviewed by investigating officer: the deceased had just spent four days in New Orleans where he had gone to a party. this would happen three or four times a year the deceased would not discuss the trips with his family

28 OUR RESPONSE - DEFERRED The concern was the reliability of the primary historian to answer certain aspects of his father s behavioral history; while there was no positive confirmation of high risk behavior the secretiveness of the trips was concerning. IV.DONOR SCREENING ( ).E.1.Men who have had sex with another man in the preceding 5 years (Refs. 17 through 46) (risk factor for HIV and Hepatitis B).

29 HIGH RISK? CASE SEVEN Hospital Referral - ER 59 year old male witnessed cardiac arrest at work pounds No lab or CXR Registered Donor

30 HIGH RISK? CASE SEVEN CASE UPDATE Next-of-Kin were daughters who performed DRAI knew father had been in the Air Force and had been stationed in England but didn t know when or for how long

31 HIGH RISK? CASE SEVEN CASE UPDATE After internal discussion of date of birth versus military age versus 1980 timeline, it was decided to contact NOK again During the conversation over possible times one of the daughters says, I remember him saying he was in England for Princess Diana s wedding!

32 OUR RESPONSE - DEFERRED Charles & Dianna wedding was on July 29 th 1981 IV.DONOR SCREENING ( ).E. 23. Persons who spent three months or more cumulatively in the United Kingdom (U.K.) (see Appendix 5) from the beginning of 1980 through the end of 1996 (Refs. 3 and 75). 24. Persons who are current or former U.S.military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996 (Refs. 3 and 75).