Referrals, authorization, and informed consent; Tissue recovery and acquisition

Form Approved

OMB No. 0990-

Exp. Date XX/XX/20XX

THE NATIONAL TISSUE RECOVERY

THROUGH UTILIZATION SURVEY

SECTION 3 – Tissue Recovery & Acquisition

The Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), through a contract with the American Association of Tissue Banks, is conducting the 2016 National Tissue Recovery through Utilization Survey (NTRUS).

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Your responses will remain anonymous in the final dataset. While results of this survey will be released in aggregate form and data may be made available in the form of a de-identified dataset, no specific institutional identifiable information will be included.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0990-xxxx. The time required to complete this information collection is estimated to average 30 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer

Tissue Recovery & Acquisition

The survey provides definitions for specific donors and tissue types. To facilitate accurate totals, count donations using the descriptions provided. Where terms are italicized, use the definitions found at AATB Standard A2.000 DEFINITIONS OF TERMS. Some terms and/or definitions are new and some have been revised. Refer to the NTRUS Definitions of Terms document provided with this survey.

Except where noted, all donations are for transplantation.

Do NOT include ocular-only donors in this survey.

To avoid double reporting, include numbers only for your main facility and your satellite facilities (if applicable). The information you are reporting is for the following physical locations(s) by name, city and state:

1. name, city, state

2. name, city, state

(need capability for multiple lines/entries)

DECEASED DONATION

How many deceased donors did your tissue bank recover tissue from for transplantation? ____

(Count one donor only once; Do not report donors or tissues recovered by another organization on your behalf; only report your own activity)

Of the total number of deceased donors, how many had an autopsy performed? ____

Of the total number of deceased donors, how many were also organ donors? ____

Of the total number of deceased donors, how many were also ocular donors? ____

LIVING DONATION

How many living donors provided tissue to your tissue bank that was recovered/acquired for transplantation? ____

(Count each donation event only once; Do not report donors or tissues recovered/acquired by another organization on your behalf; only report your own activity)

DECEASED DONATION

In the following section for deceased donors, a donor may be counted more than once, depending on tissue types donated.

Provide the number of donors in the following categories from which your tissue bank recovered these tissue types for transplantation (enter 0 for tissue types your tissue bank did not recover):

musculoskeletal ____ (i.e., bone, cartilage, osteoarticular grafts/joints, and the following soft tissue: fascia lata, ligaments, tendons, pericardium, nerves, and adipose other than from full-thickness skin)

cardiac tissue ____

vascular tissue ____

skin ____

dura mater ____

other tissue from deceased donors (specify) ____; indicate number for each_______

LIVING DONATION

In the following section for living donors, a donor may be counted more than once, depending on tissue types donated.

Provide the number of donations in the following categories that your tissue bank recovered for transplantation (enter 0 for tissue types your tissue bank did not recover):

surgical bone ____

skin for allogeneic use ____

autologous bone ____

autologous parathyroid ____

other autologous; specify __________; indicate number for each______

other tissue recovered from living donors (specify)__________; indicate number for each_______

Provide the number of birth tissue donations in the following categories that your tissue bank acquired for transplantation (enter 0 for tissue types your tissue bank did not acquire):

placenta (includes amniotic membrane, chorionic membrane, placental/chorionic disc) _____

amniotic fluid _____

Wharton’s jelly _____

umbilical cord (includes umbilical vein)_____

Of the total number of deceased donors recovered for transplantation, indicate how many tissue recoveries occurred at each of the following recovery sites:

health care facility operating room ______

hospital morgue _____

funeral home ____

dedicated tissue recovery site ______

medical examiner office (dedicated room) ______

medical examiner office (open autopsy area) ______

other recovery sites (specify) ______; indicate number for each______

TOTAL _______

□ Check if your tissue bank does not track this information (for deceased donors)

Indicate how many donors of birth tissue your tissue bank acquired from the following:

hospital delivery/birth centers  _______

freestanding birth centers  (not at a hospital) _______

other (specify) ___________

□ Check if your tissue bank does not track this information for donors of birth tissue.

Indicate how many donors of birth tissue delivered by:

cesarean section_______

vaginally _______

□ Check if your tissue bank does not track this information for donors of birth tissue.

Indicate the number of donors whose tissues were recovered for transplantation in each of the following age and gender categories

Deceased Donors Male Female

newborn – 12 years ______ _______

13 years – 20 years ______ _______

21 years – 30 years ______ _______

31 years – 40 years ______ _______

41 years – 50 years ______ _______

51 years – 60 years ______ _______

61 years – 70 years ______ _______

71 years – 80 years ______ _______

Over 80 years ______ _______

□ Check if your tissue bank does not track this information (for deceased donors)

Living Donors Male Female

newborn – 12 years ______ _______

13 years – 20 years ______ _______

21 years – 30 years ______ _______

31 years – 40 years ______ _______

41 years – 50 years ______ _______

51 years – 60 years ______ _______

61 years – 70 years ______ _______

71 years – 80 years ______ _______

Over 80 years ______ _______

□ Check if your tissue bank does not track this information (for living donors)

DECEASED DONATION

Indicate the number of deceased donors determined ineligible at the recovery site for the following reasons:

related to blood samples (e.g. plasma dilution, no sample available) _______

chart findings _____

physical assessment findings _____

logistics (e.g. insufficient body cooling, time expired, body no longer available) ______

authorization rescinded _____

post-incision findings _____

results of rapid infectious disease testing performed at recovery _____

other reason for ineligible donors at recovery site (specify) _____. indicate number ______

TOTAL _____

□ Check if your tissue bank does not track this information (for deceased donors)

LIVING DONATION

Indicate the number of living donors determined ineligible prior to recovery/acquisition for the following reasons:

related to blood samples (e.g. plasma dilution, no sample available) _______

chart findings _____

physical examination findings _____

logistics ______

informed consent rescinded _____

other reason for ineligible donors at recovery/acquisition (specify) _____, indicate number______

TOTAL _____

□ Check if your tissue bank does not track this information (for living donors)

DECEASED DONATION

Indicate the number of deceased donors determined ineligible after recovery for the following reasons (Note: this information may be obtainable from your processing tissue banks):

infectious disease testing ______

pre-processing cultures _____

medical history ______

behavioral risk history _____

autopsy results _____

tissue quality ______

other reason for ineligible donors after recovery (specify) _____; indicate number ______

TOTAL _____

□ Check if your tissue bank does not track this information (for deceased donors)

LIVING DONATION

Indicate the number of living donors determined ineligible after recovery/acquisition for the following reasons (Note: this information may be obtainable from your processing tissue banks, if different):

infectious disease testing ______

pre-processing cultures _____

medical history ______

behavioral risk history _____

tissue quality ______

other reason for ineligible donors after recovery/acquisition (specify) _____; indicate number ______

TOTAL _____

□ Check if your tissue bank does not track this information (for living donors)

□ Check here if your tissue bank forwards tissue for processing into cell therapy products, biologics, or drugs (Note: this information may be obtainable from your processing tissue banks):

What type of tissue is sent?

□ bone

□ adipose

□ other (specify) _____

DECEASED DONATION

Provide the number of deceased donors where (any) tissues were recovered specifically for research:________

LIVING DONATION

Provide the number of living donors where (any) tissues were recovered/acquired specifically for research:________