Guidelines for Tissue Management: Meeting JCAHO Requirements

By D. Ted Eastlund, MD, American Association of Blood Banks, and A. Brad Eisenbrey, PhD

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has established stringent requirements for hospitals that receive, store, transplant, or distribute human tissue. In response, the American Association of Blood Banks (AABB) has developed a comprehensive guide that outlines the rationale behind these requirements and provides practical suggestions for implementing effective quality management processes.

Oversight and Responsibility: The Key to Successful Tissue Management

A critical component of tissue management is ensuring that hospitals have a clear oversight structure in place. This includes designating responsibility for tissue management, supplier qualification, and process control for tissue allografts.

Supplier Qualification: Ensuring Compliance with FDA Registration and State Licensing

Hospitals must ensure that their tissue suppliers meet the necessary regulatory requirements, including FDA registration and state licensing. Our guide provides a detailed overview of the necessary steps to take when qualifying suppliers.

Inspection, Documentation, and Process Control: The Heart of Tissue Management

Effective tissue management relies on a robust inspection and documentation process. Our guide outlines the necessary steps to take when inspecting and documenting tissue upon receipt, as well as strategies for maintaining process control for tissue allografts.

Traceability and Record-Keeping: Ensuring Accountability in Tissue Management

Maintaining accurate and detailed records is essential for ensuring traceability and accountability in tissue management. Our guide provides guidance on the necessary steps to take when implementing a record-keeping system.

Storage of Transplantable Tissue: Best Practices for Maintaining Viability

The storage of transplantable tissue is a critical component of tissue management. Our guide outlines the necessary steps to take when storing tissue, including strategies for maintaining viability and preventing contamination.

Investigating and Reporting Adverse Events: A Critical Component of Tissue Management

In the event of an adverse event, it is essential that hospitals have a clear protocol in place for investigating and reporting the incident. Our guide provides guidance on the necessary steps to take when investigating and reporting adverse events.

Handling Tissue Recalls and Withdrawals: Minimizing Risk and Ensuring Compliance

In the event of a tissue recall or withdrawal, it is essential that hospitals have a clear protocol in place for managing the situation. Our guide provides guidance on the necessary steps to take when handling tissue recalls and withdrawals.

This comprehensive guide provides a detailed crosswalk of JCAHO requirements with applicable AABB standards, ensuring that hospitals have the necessary tools to implement effective quality management processes.

Product Details:

Publisher: American Association of Blood Banks (AABB)

Edition: 1st edition (January 1, 2006)

Language: English

Format: Paperback

Pages: 20

ISBN-10: 1563952408

ISBN-13: 978-1563952401