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 2 – Referrals, Authorization, Informed Consent

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

Referrals, Authorization, Informed Consent

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

Enter the total number of donor referrals by source (enter counts, not percentages). Consider the “source” to be the facility or person reporting the death. Enter 0 at a selection if not applicable.

hospitals _____

medical examiners/coroners ______

law enforcement ______

funeral home ______

extended care facilities/Nursing homes (includes hospice/donor initiated) ______

first responders (paramedics/EMS) ______

donor family (home)

other source (specify) ______; indicate number ______

TOTAL ______

LIVING DONATION

Enter the total number of donor referrals by source (enter counts, not percentages). Consider the “source” to be the facility or person making the referral. Enter 0 at a selection if not applicable

hospital surgical department _____

hospital delivery/birth centers  _______

freestanding birth centers  (not at a hospital) _______

physicians _____

family/donor initiated (home) ______

other source (specify) ______; indicate number ______

DECEASED DONATION

How many requests for authorization did your tissue bank make? _____

How many authorizations did your tissue bank obtain in total? ______

Enter the number of authorizations that came from First Person/Donor Designation/donor registry ______

Enter the number of authorizations that came from an “intent registry” (a registry but not legally valid) ______

Enter the number of authorizations from an authorizing person or persons ______

How many requests for authorization were denied? ______

Enter the number when an authorizing person was not available ______

How many authorizations were obtained but tissue was not recovered? ______

LIVING DONATION

How many requests for informed consent did your tissue bank make? _____

How many informed consents did your tissue bank obtain in total? ______

How many requests for informed consent were denied? ______

How many informed consents were obtained but tissue was not acquired? ______

DECEASED DONATION

Indicate the number of authorizations for donation that were requested by the following:

Report the number by a trained requestor (An individual deemed competent by the OPO or agency to seek authorization for donation):

requestor at tissue bank/OPO who only handles tissue donation authorization ______

hospital personnel ______

requestor at tissue bank /OPO who also handles organ donation authorizations ______

designated screening/authorization service ______

medical examiner/coroner _______

other authorizations were requested by whom? ______; indicate number ______

□ Check if this information is not obtainable

Report the number by a non-trained requestor:

hospital personnel ______

medical Examiner/Coroner _______

other authorizations were requested by whom?______; indicate number______

□ Check if this information is not obtainable

LIVING DONATION

Indicate the number of informed consents for donation that were requested by the following:

requestor at tissue bank/OPO who only handles tissue donation authorization ______

hospital personnel ______

hospital delivery/birth center personnel _____

freestanding birth center personnel (not at a hospital) _____

physicians _____

other informed consents were requested by whom?______; indicate number______

□ Check if this information is not obtainable

DECEASED DONATION

Does your authorization process include a request regarding international distribution of the gift?

□ Yes

□ No

Does your authorization process include a request regarding for-profit or not-for-profit involvement or restrictions on the gift?

□ Yes

□ No

LIVING DONATION

Does your informed consent process include a request regarding international distribution of the gift?

□ Yes

□ No

Does your informed consent process include a request regarding for-profit or not-for-profit involvement or restrictions on the gift?

□ Yes

□ No

DECEASED DONATION

(Note: the following information may be obtainable from the organization contracted to handle your donor referrals.)

Indicate the number of ALL referrals determined ineligible during screening (prior to going on site for recovery) _____

Indicate the number of ALL referrals determined ineligible during screening (prior to going on site for recovery) for the following reasons:

age ______

medical history ______

behavioral risk history _____

travel/residence history

time restrictions _____

infectious disease testing _____

plasma dilution ______

trauma _____

medical examiner/coroner restrictions _____

funeral home restrictions (i.e., body embalmed) ______

other ineligible referrals during screening (specify) _____; indicate number _______

Choose only one:

□ The reasons were obtainable for all referrals. 

□ The reasons were obtainable for some referrals. 

□ The reasons were not obtainable.

LIVING DONATION

(Note: the following information may be obtainable from the organization contracted to handle your donor referrals.)

Indicate the number of ALL referrals determined ineligible during screening (prior to recovery/acquisition) _____

Indicate the number of ALL referrals determined ineligible during screening (prior to recovery/acquisition) for the following reasons:

medical history ______

behavioral risk history _____

travel/residence history_____

infectious disease testing _____

plasma dilution ______

other ineligible referrals during screening (specify) _____; indicate number _______

Choose only one:

□ The reasons were obtainable for all referrals. 

□ The reasons were obtainable for some referrals. 

□ The reasons were not obtainable.

DECEASED DONATION

Estimate the percentage of authorizations that provided use of the gift for research:______%

LIVING DONATION

Estimate the percentage of informed consents that provided use of the gift for research:______%