Clarification of policies that reference the PHS Guideline

Clarification of policies that reference the PHS Guideline

The June 19, 2013, release of the PHS Guideline for Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation, made policy ambiguous, specifically in how members must identify organ donors that may be at increased risk for transmitting HIV, HBV and HCV to organ recipients. To clarify this language and reduce confusion in the transplant community, the OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) proposed modifications and asked  the OPTN/UNOS Executive Committee to consider them  in a two step process.

Step 1 (approved on Aug. 27, 2013)

Standardize the nine policies that reference the PHS Guideline and create a new policy (3.1.14) to define the PHS Guideline.

The definition allows members to use either version: the 1994 or the 2013 version of the PHS Guideline for the medical-social evaluation questions posed to potential donors. Additionally, beginning October 1, 2013, it requires members to specify which version they are using in the donor highlights section of DonorNet. From a practical perspective, this is the current state of affairs since the policies are unclear about which version is required. Some members have already updated their processes to the new 2013 guideline and variation in member practice will make compliance monitoring more difficult in this period.

Programming is already underway to update fields in DonorNet® and on the deceased donor registration form (DDR) that collect information on whether a donor is at increased risk for transmitting infectious disease.

Below are member responsibilities related to this change:

OPOs:
You may use either the 1994 or the 2013 PHS Guideline for medical-social evaluation questions to determine if a deceased donor is at increased risk for HIV, HBV, or HCV transmission.  By October 1, 2013, all staff must document  in the donor highlights section of DonorNet® which guideline they used to evaluate each particular donor.

Living Donor Recovery Centers:
You may use either the 1994 or the 2013 PHS Guideline for medical-social evaluation questions to determine if a living donor is at increased risk for HIV, HBV, or HCV transmission.  Your hospital staff are encouraged to document in the donor record which guideline you used to evaluate each particular donor.

Transplant Programs:
Your program should become familiar with the differences  in the medical-social evaluation questions between the 1994 Guidelines and the new 2013 Guideline so that staff may educate potential organ recipients regarding organ offers from donors at increased risk for the transmission of HIV, Hepatitis B, and Hepatitis C. Read a document summarizing the differences.

 

Step 2 (will be considered by Board of Directors in Nov. 2013)
Update the definition of PHS Guideline to permit members to only use the 2013 version of the PHS Guideline. 

A date to require use of only the 2013 Guideline will be determined at that time.  This will allow members time to train staff and update any internal documentation, systems, and processes necessary to comply with the 2013 version.

Step 3 (ongoing)
A line-by-line review of the rest of the recommendations in the 2013 Guideline (including donor and recipient testing and the collection and storage of donor and recipient specimens) is already underway.  This includes representation from the DTAC, OPO, Operations & Safety, and Living Donor Committees.  Any additional policy modifications related to this effort will be released for public comment in 2014.

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