Communicable disease testing and adverse outcome reports

Form Approved

OMB No. 0990-

Exp. Date XX/XX/20XX

THE NATIONAL TISSUE RECOVERY

THROUGH UTILIZATION SURVEY

SECTION 7 – Communicable Disease Testing & Adverse Outcome Reports

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 60 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

Communicable Disease Testing & Adverse Outcome Reports

There are three options for answering questions about communicable disease testing of donors. Check which one applies to your tissue bank:

□ Reporting totals only for donor communicable disease testing that our tissue bank DIRECTLY ordered. This means our tissue bank supplied the sample to the testing laboratory under our own contract and results may have been shared with others entities that received tissue (this is preferred); or

□ Reporting totals only for donor communicable disease testing ordered by others through a contract or agreement with a tissue recovery program. This means our tissue bank did not directly order the tests (this is acceptable);

□ Reporting totals for donor communicable disease testing that uses a combination of the two selections above (this is acceptable but not preferred because it could lead to double reporting); or

□ Our tissue bank is not involved in ordering communicable disease testing. (skip to Adverse Outcome Reports section)

List all test(s) that your tissue bank relies upon to confirm a repeat-reactive syphilis screening test?

□ VDRL

□ FTA-ABS

□ MHA-TP

□ Olympus PK TP System

□ ASI TPHA Test

□ CAPTIA TM Syphilis (T. Pallidum) - G

□ TPHA Screen

□ Other____ Specify: _______

□ N/A – confirmatory testing is not performed

DECEASED DONORS

Provide the following donor test counts and results for [calendar year]:

Assay	Screening Test Results			Confirmatory/Supplemental Test Results
	# Donors Tested	# Donors Nonreactive/Negative	# Donors Repeatedly Reactive/Positive or Indeterminate	# Donors Negative	# Donors Positive	# Donors Indeterminate
HBsAg
anti-HBcAb (total)
anti-HBcAb (IgM)
anti-HCV
anti-HIV-1/2
anti-HIV-2
Anti-HTLV I/II
Treponemal
Non-treponemal
NAT (HIV-1)
NAT (HIV-2)
NAT (HCV)
NAT (HIV-1/HCV)
NAT (HBV)
NAT (HIV-1/HBV/HCV)
NAT (HIV-1/HIV-2/HBV/HCV)
NAT (WNV)
anti-T.cruzi
anti-CMV

LIVING DONORS

Provide the following donor test counts and results for [calendar year]:

Assay	Screening Test Results			Confirmatory/Supplemental Test Results
	# Donors Tested	# Donors Nonreactive/Negative	# Donors Repeatedly Reactive/Positive or Indeterminate	# Donors Negative	# Donors Positive	# Donors Indeterminate
HBsAg
anti-HBcAb (total)
anti-HBcAb (IgM)
anti-HCV
anti-HIV-1/2
anti-HIV-2
Anti-HTLV I/II
Treponemal
Non-treponemal
NAT (HIV-1)
NAT (HIV-2)
NAT (HCV)
NAT (HIV-1/HCV)
NAT (HBV)
NAT (HIV-1/HBV/HCV)
NAT (HIV-1/HIV-2/HBV/HCV)
NAT (WNV)
anti-T.cruzi
anti-CMV

Adverse Outcome Reports

The following information only considers tissue products regulated solely under Section 361 of the PHSA (i.e., conventional tissue).

Indicate how many reports your tissue bank received of suspected transmission of disease or of graft failure following transplantation and information regarding reporting to others. Also, provide assessment/outcome information for reports received.

Reports Received		Reported to Others by Tissue Bank			Report Assessment/Outcome
	Total # of Reports	# Reported to FDA	# Reported to international health authorities	# Reported to local/state health authorities	Likely/ Probably caused by the graft*	Proven as caused by the graft*	Not otherwise specified*	Resulted in recipient death
Bacterial
Viral
Fungal
Malignancy
Other infection
Graft Failure (only)

* Use these definitions:

Likely/Probably caused by the graft =

(EUSTITE definition) When the evidence is clearly in favor of attributing the adverse reaction to the quality/safety of tissues/cells.

(NOTIFY definition for “Probable”) Strong evidence suggesting but not proving a disease transmission.

Proven as caused by the graft =

(EUSTITE definition for “definite/certain”) When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the quality/safety of tissues/cells.

(NOTIFY definition for “Proven”) Clear evidence of the same infection disease in the donor and at least one of the recipients.

Not otherwise specified =

Does not meet definition of “Likely/Probably” or “Proven”

The following information only considers tissue products regulated as tissue as a device, tissue as a drug, or tissue as a biologic.

Reports Received		Reported to Others by Tissue Bank			Report Assessment/Outcome
	Total # of Reports	# Reported to FDA	# Reported to international health authorities	# Reported to local/state health authorities	Likely/ Probably caused by the graft*	Proven as caused by the graft*	Not otherwise specified*	Resulted in recipient death or serious injury
Bacterial
Viral
Fungal
Malignancy
Other
Graft malfunction (only) (e.g., failure of expected pharmacological action