JCAHO Tissue Standards and Challenges
The Joint Commission on Accreditation
of Healthcare Organizations is the
nation’s oldest and largest accrediting
body. JCAHO evaluates more than
15,000 hospitals, organizations and
programs in the United States in its
mission to improve the safety and
quality of care provided to the public.
JCAHO made its tissue storage and
issuance standards applicable to hospitals
as of July 1, 2005, with the new
standards covering three major areas:
processes for tissue handling; record
keeping for traceability; and investigation
of adverse events. The intent is to
help ensure a well-coordinated system
for managing transplanted tissues.
A hospital’s first step toward compliance
is to assign responsibility for tissue
program oversight. Tissue sources
then must be validated via state
agency licensing or FDA registration.
Written procedures must cover
every step for all tissue: ordering,
receipt, storage, transporting, handling,
usage, receiving, temperature
monitoring and recording, equipment
capabilities, state and federal regulation
compliance, and verification of tissue
integrity.
The record-keeping challenge
continues with the retrieval of those
records in the event of adverse patient
reaction or provider recall. Records
should allow bidirectional tracing of
any tissue from the donor or source
facility to the recipient and vice versa.
Documentation of tissue use should
also be included in the patient’s clinical
record. Names of staff who prepare,
issue or accept tissue and the
dates and times of the occurrences
are all required record entries.
In addition, records should enable the
tracking and identification of tissue
preparation and processing materials,
including the instructions used therein.
All tissue records should be kept a
minimum of 10 years from the date of
tissue transplant, distribution, disposition
or expiration, whichever is latest.
Finally, hospitals should have procedures
to identify and then investigate
adverse reactions. These procedures
should ensure the reporting of
such cases to the source facility and
recipients. |
