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Rules & Regulations: JCAHO standards for tissue and cellular products mirror Good Tissue Practice regulations

Stem Cell Regulation Report, December 16, 2005

Rules & Regulations

JCAHO standards for tissue and cellular products mirror Good Tissue Practice regulations

The following Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards apply to participating organizations, like tissue banks, surgery, and outpatient centers, that store or issue tissue like bone, cornea, skin, stem cells, or other tissue or cell based products.

Standard PC.17.10: Standardize procedures to acquire, receive, store, and issue tissues and cellular-based products.

  • Put someone in change of overseeing the tissue program for the entire organization.

  • Validate that tissue sources are licensed and registered with the Food and Drug Administration.

  • Coordinate tissue ordering, receipt, storage, and use throughout the organization.

  • Log all incoming tissue.

  • Monitor temperature in storage areas, refrigerators, and freezers.

  • Make sure storage equipment has working alarms and emergency backup.

  • When tissue product is received, make sure the package retained integrity and that the range of temperature during transportation was controlled and acceptable.

    Standard PC.17.20: Make sure tissues can be traced from donor or source facility to all recipients.

  • Track and identify any materials used to prepare or process the tissue.

  • Identify the date, time, and staff member who prepared or issued the tissue.

  • Identify the date, time, and staff member who accepted the tissue.

  • Include recipient's clinical record of tissue use, including the unique identifier of the tissue.

  • Document source facility, original donor and lot, expiration dates, and all recipients.

  • Retain records for at least 10 years or longer if required by state and federal law.

    Standard PC.17.30: Define a process to investigate adverse events related to tissue or donor infections. Effective communication of an adverse event directly related to tissue use is critical to patient safety.

  • Create procedures to examine adverse events.

  • Promptly report adverse events to source facilities.

  • Sequester tissue involved in an adverse event.

  • Identify and inform tissue recipients of infection risk.

    Source: JCAHO