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.

1. More on Tissue Management
By 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 ensure 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?
o 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?
o 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?
o 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

2. the Hospital to ensure tissue is available for upcoming scheduled surgeries either during
periods of low activity or as a back-up supplier.)
o 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?
o 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.)?
o When functioning as a tissue supplier, full compliance with all state/federal laws
for maintaining the required documentation as a supplier must be maintained.