JCAHO approves standards for tissue storage, issuance
By Donna Toohey
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently approved standards for the storage and issuance of transplant and implant tissue for hospitals, critical access hospitals, and ambulatory office-based surgery or outpatient centers. Slated to become effective on July 1, 2005, the standards cover bone, cornea, skin, heart valves/conduits, tendons, fascia, bone marrow, blood vessels, cartilage, cord blood and reproductive tissue specimens.
An independent, not-for-profit organization, JCAHO is the nation’s primary standards-setting and accrediting body in health care. JCAHO standards set forth performance expectations for activities that affect the safety and quality of patient care and are developed in consultation with health care experts, providers, measurement experts, purchasers and consumers. The AAOS Biological Implants Committee submitted comments on the proposed tissue storage and issuance standards last year.
Briefly summarized, the standards call for organizations to develop procedures to address the critical areas of tissue acquisition and storage, recordkeeping and tracking, and adverse event/infection follow-up.
The organization uses standardized procedures to acquire, receive, store, and issue tissues.
This standard requires organizations to develop and implement procedures that assign responsibility for the oversight of the organization’s tissue program, including adherence to source facility or manufacturer written instructions; quality control temperature monitoring for tissue storage; and coordination of ordering, receipt, transportation and issuance of tissues throughout the organization.
In addition, each organization that acts as a source facility by supplying its own tissues must comply with the appropriate state and/or federal regulations.
The organization’s record keeping permits the traceability of all tissues from the donor or source facility to all recipients or other final dispositions.
This standard compels organizations to maintain records that permit received tissue to be traced to end recipients and/or other final dispositions, including disposal.
These records must identify dates, times and names of staff involved in accepting, preparing and issuing tissue, and must note the materials used in the preparation or processing of tissue. Source facility information, such as expiration date and donor or lot identification numbers, must also be maintained. Each tissue recipient’s medical record must document the tissue use and the unique identifier for the tissue. All records must be maintained for a minimum of 10 years.
The organization has a defined process to investigate adverse events to tissue or donor infections.
This standard requires the organization to develop procedures for the investigation of adverse events, including disease transmission or other complications suspected of being directly related to the tissue use.
The organization must also promptly report post-transplant infections to the source facility and must inform patients who have been implanted with tissue subsequently found to be positive for an infectious disease. The organization must follow their own procedures when adverse or suspected adverse events occur.
Tissue lab standards
JCAHO has also approved similar standards for laboratories. To earn and maintain JCAHO accreditation, an organization must undergo an on-site survey by a JCAHO survey team at least every three years. For more information, and for the official, unabridged standards, visit the JCAHO Web site, http://www.jcaho.org
Donna Toohey, regulatory analyst, department of research and scientific affairs, is the staff liaison to the AAOS Biological Implants Committee, which monitors areas of biologic concern with regard to the practice of orthopaedics. She can be reached at firstname.lastname@example.org.