The 2012 Hospital & Laboratory Accreditation Standards
Standards TS.03.03.01
The hospital/organization investigates adverse events related to tissue use or donor infections.
Elements of Performance for TS.03.03.01
A 1. The hospital/organization has a written procedure to investigate tissue adverse events,
including disease transmission or other complications that are suspected of being
directly related to the use of tissue.
A 2. The hospital/organization investigates tissue adverse events, including disease transmission or
other complications that are suspected of being directly related to the use of tissue
(See also IC.01.03.01 EP 3)
A 3. As soon as the hospital/organization becomes aware of a post-transplant infection or other
adverse event related to the use of tissue, it reports the infection or adverse event
to the tissue supplier.
A 4. The hospital/organization sequesters tissue whose integrity may have been compromised or
that is reported by the tissue supplier as a suspected cause of infection.
A 5. The hospital/organization identifies and informs tissue recipients of infection risk when donors
are subsequently found to have human immunodeficiency virus (HIV), human T-
lymphotropic virus-I/II (HTLV-I/II), viral hepatitis, or other infectious agents
known to be transmitted through tissue.
**According to Health Insurance Portability and Accountability Act (HIPPA) regulations regarding protected health information, “a covered entity may disclose protected health information for public health activities or other purposes to a person subject to the jurisdiction of the Food and Drug Administration (FDA) for the following purposes:
- To track products if the disclosure is made to a person required or directed by the FDA to track the product.
- To enable product recalls, repairs or replacement (including locating and notifying individuals who have received products of product recalls, withdrawals, or other problems” (45CFR 164.512(b) (iii) (B) and (C)).
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