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Thursday 1:23 CST, October 2, 2014

Standards FAQ Details

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Adverse Tissue Reaction Policies
Updated | October 01, 2010
Q:  What is The Joint Commission looking for in adverse tissue reaction policies?

A:  Policies addressing the investigation of adverse tissue reactions should define two essential processes:

  1. Reporting potential disease transmission from the donor source facility to the patient, and
  2. Reporting adverse patient reactions to the donor source facility.

Reporting: Donor Source Facility to Patient

The Joint Commission encourages facilities to develop reporting policies comparable to the "look back" procedures required for investigation of potential disease transmission in blood products.  For example, this would include receipt of notification from the donor facility, determination of disposition, quarantine of donations in inventory from the indicated source, disposal, and notification of the recipient(s).  The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus.  Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased.  References for policy development include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR 482.27(c)(4-8)] and theFDA’s Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.

Reporting: Patient to Donor Source Facility

Similar to The Joint Commission requirements for suspected transfusion reactions, organizations need to develop policies and procedures for suspected tissue reactions.  The process should be detailed and address criteria for identifying a suspected adverse tissue reaction, initial reporting internally, documented investigation of the complication, and prompt reporting to the donor source facility.  When developing their process, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis).  Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue.  Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the FDA regulations for Current Good Tissue Practice or participate inMedWatch, the FDA’s reporting system for adverse events, product use errors and product quality problems associated with medical products.

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