As accredited organizations develop relationships with other independent health care entities in their communities, it is important to remember that law and regulation requirements must be addressed. One particular area of risk is tissue management.

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MORE ON TISSUE MANAGEMENT
Darlene Christiansen, Ed.D, RN, LNHA, HACP
As accredited organizations develop relationships with other independent health care entities in their
communities, it is important to remember that law and regulation requirements must be addressed.
One particular area of risk is tissue management.
Consider the following scenario and the recent responses from The Joint Commission to six questions.
SCENARIO:
An independent surgery center, with no organizational or functional relationship to your
organization, is seeking your support with tissue management. Specifically, they are
seeking support from your hospital for an interim period of time for receipt, storage, and
later distribution of tissue by the hospital to the ambulatory surgery center (ASC). The ASC
is seeking support from the Hospital as a back-up tissue supplier. (Interim services would
be supplied by the hospital to insure tissue is available for upcoming scheduled surgeries
either during periods of low activity or as a back-up supplier.)
QUESTIONS &THE JOINT COMMISSION, STANDARDS INTERPRETATION, RESPONSES:
1. Can the Hospital relationship with the Ambulatory Surgery Center for receipt,
storage, and later distribution of the tissue be handled through a contracted
relationship?
a. Yes, this could be handled via a contractual arrangement; however, the responses
to the following questions must be compliant.
2. Is a contracted relationship required or can the Hospital provide services to the
Ambulatory Surgery Center through a letter of agreement?
a. The organization’s leadership and legal counsel would determine the best approach
to managing the relationship, performance expectations, etc. between the two
entities.
3. If the answer to 1 or 2 is yes must the hospital be designated as a tissue
supplier?
a. Yes, the hospital must be designated as a tissue supplier and be compliant with all
state and federal laws
4. Can the Hospital designate itself, without working through the OPO and FDA, as
an interim or back-up supplier or must the hospital work through the OPO and
the U.S. Food and Drug Administration to obtain their approval? (Interim
services would be supplied by the Hospital to insure tissue is available for
upcoming scheduled surgeries either during periods of low activity or as a back-
up supplier.)
a. No, there is no provision to act as an “interim” supplier.
5. Under the tissue standards is the Hospital required to be registered with the U.S.
Food and Drug Administration (FDA) as a tissue supplier and maintain a state
license when required?
a. Yes. The organization must be fully licensed and registered to serve as a supplier.
6. If the Hospital functions as a tissue supplier, is the hospital required to maintain
two separate sets of documentation (one as a tissue supplier to another
healthcare entity and one to manage tissues for its own patient population.)?
a. When functioning as a tissue supplier, full compliance with all state/federal laws
for maintaining the required documentation as a supplier must be maintained.
For more information: www.courtemanche-assocs.com