OPTN/UNOS Guidance Regarding H1N1 and Implications for Transplantation

[okarol]

Release Date:
09/02/2009    

OPTN/UNOS Guidance Regarding H1N1 and Implications for Transplantation

This communication, developed by UNOS staff and the OPTN/UNOS Disease Transmission Advisory Committee, in consultation with members of the Liver and Intestinal Transplantation and Thoracic Transplantation Committees, is intended to provide information to transplant centers and OPOs as they prepare for the upcoming flu season.

The pandemic (H1N1) 2009 influenza virus continues to have potential for significant activity in the upcoming influenza season, and patients having severe presentations requiring intensive care can be expected. Pandemic (H1N1) 2009 influenza in southern hemisphere countries, notably Australia and Argentina, resulted in the lack of availability of ICU beds and ventilators, and has impacted the activities of both organ procurement agencies and transplant centers. This statement is developed in large part from the experience and recommendations of the Australian transplant community.

An influenza pandemic will have a significant impact on society, and will strain health care resources. A large cross-section of the population may become unable to work either through direct infection with influenza, or indirectly through the need to care for sick family members or children who are ordered home by school closures. As a result, there is a potential impact on staffing availability and medical resources to the transplant community. Our goal is to minimize the impact of the pandemic on organ transplantation.

Pandemic (H1N1) 2009 influenza is a new strain of virus; there is minimal acquired immunity to it, especially in younger people. Current knowledge regarding the virulence and transmission of the virus in organ donors is limited. The evidence is based on case reviews, autopsy findings and comparative opinion based on the other viral infections in donors and non-donors. Known or suspected H1N1 influenza, as well as seasonal influenza, in a potential organ donor requires careful consideration of the specific risks and management of possible viral transmission in immunosuppressed recipients. The transplantation of non-lung organs from an H1N1 positive donor has occurred in Australia, but the outcome is yet to be reported.

The clinical presentation and course of donor-derived influenza has not been defined; clinical infection may be different and respiratory tract involvement may be delayed. Testing of alternative specimens, including blood, stool, and urine, in addition to respiratory cultures, should be considered in any patient with febrile illness or other evidence of infection after receiving an organ from a donor with known or suspected pandemic (H1N1) 2009 influenza.

Since respiratory and gastro-intestinal manifestations are well documented in this pandemic, the Ad Hoc Disease Transmission Advisory Committee suggests that lungs and intestine should not be recovered for transplantation from donors known to be infected with novel H1N1 virus. In addition, lungs should not be recovered from donors with seasonal influenza. Recovery and transplantation of other organs from donors with H1N1 or seasonal influenza may be considered, but donor suitability should be reviewed with an infectious disease consultant or OPO medical director.

Please consider the following recommendations as well:

    * OPOs and transplant centers should take necessary steps to coordinate their planning and actions with the influenza pandemic plans of their local and state public health agencies and authorities.
    * Transplant centers, in consultation with their infectious disease experts, need to establish policies for accepting these organs and monitoring the recipients following the transplantation of such organs. Please remember that one of the CMS Conditions of Participation requires that potential recipients be informed of disease transmission risks.
    * Transplant centers should investigate the pandemic plans in their hospital and how an outbreak could affect their ability to maintain functionality of their outpatient clinics, inpatient services, and operating room facilities.
    * Transplant centers should determine who may be affected by school closures and who would have the capacity (both physical and infrastructural - i.e. phone, internet, and computer access) to work from home.
    * Transplant centers should determine how seasonal influenza vaccine and influenza A (H1N1) 2009 monovalent vaccine will be made available to their patients and staff and what additional resources (i.e. information letters, additional staffing for vaccination clinics, etc) are needed for implementation of this plan.
    * OPOs should review any pandemic plans that they and their donor hospitals and transplant centers have developed and prepare to implement and follow them.
    * OPOs should determine who may be affected by school closures and who would have the capacity (both physical and infrastructural - i.e. phone, internet, and computer access) to work from home.
    * OPOs should determine which staff members are eligible for seasonal influenza vaccine and influenza A (H1N1) 2009 monovalent vaccine and how these will be provided for (influenza A (H1N1) 2009 monovalent vaccine , for example, may require registration with the local health department for health care organizations).
    * The possibility of pandemic (H1N1) 2009 influenza should be considered in all potential organ donors and appropriate screening performed based on CDC Guidelines.
    * Potential organ donors meeting the case definitions for pandemic (H1N1) 2009 influenza should have viral confirmatory testing for the virus, and the reports should be available to the intensivist or medical directors responsible for screening potential organ donors.
    * Treatment of the donor prior to procurement and/or recipient following donation with antivirals as recommended by current CDC guidance (www.cdc.gov/h1n1flu/recommendations.htm) should be strongly considered.

Future updates will be posted to the newsroom section of the OPTN and UNOS Web sites. Be sure to check www.flu.gov, www.cdc.gov/h1n1flu, and other pertinent Federal, State, and local Web sites to keep abreast of developments regarding the pandemic.

http://www.unos.org/news/newsDetail.asp?id=1292

[okarol]

Release Date:
11/24/2009

OPTN/UNOS Guidance Regarding H1N1 and Implications for Transplantation

This communication, developed by the OPTN/UNOS Disease Transmission Advisory Committee, in consultation with members of the Liver and Intestinal Organ Transplantation and Thoracic Organ Transplantation Committees, is intended to provide information to transplant centers and OPOs as they prepare for the upcoming flu season.

The pandemic (H1N1) 2009 influenza virus continues to have potential for significant activity in the upcoming influenza season, and patients having severe illness requiring intensive care can be expected. Pandemic (H1N1) 2009 influenza in southern hemisphere countries, notably Australia and Argentina, resulted in the lack of availability of ICU beds and ventilators, and has impacted the activities of both organ procurement agencies and transplant centers. This statement is developed in large part from the experience and recommendations of the Australian transplant community.

An influenza pandemic will have a significant impact on society, and will strain health care resources. A large cross-section of the population may become unable to work either through direct infection with influenza, or indirectly through the need to care for sick family members or children who are ordered home by school closures. As a result, there is a potential impact on staffing availability and medical resources to the transplant community. Our goal is to minimize the impact of the pandemic on organ transplantation.

Pandemic (H1N1) 2009 influenza is a new strain of virus; there is minimal acquired immunity to it, especially in younger people. Current knowledge regarding the virulence and transmission of the virus in organ donors is limited. The evidence is based on case reviews, autopsy findings and comparative opinion based on the other viral infections in donors and non-donors. Known or suspected H1N1 influenza, as well as seasonal influenza, in a potential organ donor requires careful consideration of the specific risks and management of possible viral transmission in immunosuppressed recipients. The transplantation of non-lung organs from an H1N1 positive donor has occurred in Australia, but the outcome is yet to be reported.

The clinical presentation and course of donor-derived influenza has not been defined; clinical infection may be different and respiratory tract involvement may be delayed. Testing of alternative specimens, including blood, stool, and urine, in addition to respiratory cultures, should be considered in any patient with febrile illness or other evidence of infection after receiving an organ from a donor with known or suspected pandemic (H1N1) 2009 influenza. Any proven or suspected cases of donor-derived novel H1N1 infection in a recipient must be reported via the OPTN Patient Safety System per current policy.

Since respiratory and gastro-intestinal manifestations are well documented in this pandemic, the Ad Hoc Disease Transmission Advisory Committee suggests that lungs and intestine should not be recovered for transplantation from donors known to be infected with novel H1N1 virus. In addition, lungs should not be recovered from donors with seasonal influenza. Recovery and transplantation of other organs from donors with H1N1 or seasonal influenza may be considered, but donor suitability should be reviewed with an Infectious Diseases consultant or OPO medical director.

OPOs should consider the following questions when evaluating potential organ donors:

* Did the donor present with or have, during their hospital course, a febrile illness or influenza-like illness (ILI)? ILI is defined as fever (temperature of 100°F <37.8 °C> or greater) and a cough and/or a sore throat in the absence of a KNOWN cause other than influenza. (http://www.cdc.gov/h1n1flu/identifyingpatients.htm)
* Does the potential donor have recent history of:
- Documented H1N1?
- Household exposure to an individual with an influenza-like illness?
- Who was the individual s/he was exposed to (i.e. relation)?
- Duration of exposure?

IF YES TO ANY, additional testing is warranted and should be discussed with your Infectious Diseases consultant or OPO medical director.

For donors with proven or suspected influenza, the OPO should obtain and the Transplant Centers should consider the following specific information in order to make informed decisions regarding organ acceptance:

* Date of onset of flu-like illness
* Initial diagnosis and date
- Collection method (nasal swab, nasal wash, throat swab, BAL, other)
- Testing used (You should know specifically what test type was done (rapid antigen test, culture, PCR, other) as the relative sensitivities of the different tests vary greatly).
- Results

It is important to note that rapid antigen testing has poor sensitivity (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5830a2.htm) and as such, negative testing does not rule out infection. Further testing with more sensitive methods (such as culture or PCR), needs to be considered (http://www.cdc.gov/h1n1flu/guidance/rapid_testing.htm).

* Was subsequent testing completed?
- Date(s) performed
- Collection method (nasal swab, nasal wash, throat swab, BAL, other)
- Testing used (You should know specifically what test type was done (rapid antigen test, culture, PCR, other) as the relative sensitivities of the different tests vary greatly)
- Results
* Management issues:
- What specific antivirals (Rimantadine, Amantadine, Oseltamivir, Zanamivir, or other anti-influenza antiviral) were used for treatment or prophylaxis
- Dosage
- Date initiated
* Duration of therapy and time of offer
* Cause of death - was it specifically flu related?

Please consider the following general recommendations as well:

* The possibility of pandemic (H1N1) 2009 influenza should be considered in all potential organ donors and appropriate screening performed based on CDC Guidelines.
* Potential organ donors meeting the case definitions for pandemic (H1N1) 2009 influenza should have viral confirmatory testing for the virus, and the reports should be available to the intensivist or medical directors responsible for screening potential organ donors.
* Treatment of the donor prior to procurement and/or recipient following donation with antivirals as recommended by current CDC guidance (http://www.cdc.gov/h1n1flu/recommendations.htm) should be strongly considered.
* OPOs and transplant centers should take necessary steps to coordinate their planning and actions with the influenza pandemic plans of their local and state public health agencies and authorities.
* Transplant centers, in consultation with their infectious disease experts, need to establish policies for accepting these organs and monitoring the recipients following the transplantation of such organs. Please remember that one of the CMS Conditions of Participation requires that potential recipients be informed of disease transmission risks.
* Transplant centers should investigate the pandemic plans in their hospital and how an outbreak could affect their ability to maintain functionality of their outpatient clinics, inpatient services, and operating room facilities.
* Transplant centers should determine who may be affected by school closures and who would have the capacity (both physical and infrastructural - i.e. phone, internet, and computer access) to work from home.
* Transplant centers should determine how seasonal influenza vaccine and influenza A (H1N1) 2009 monovalent vaccine will be made available to their patients and staff and what additional resources (i.e. information letters, additional staffing for vaccination clinics, etc) are needed for implementation of this plan.
* OPOs should review any pandemic plans that they and their donor hospitals and transplant centers have developed and prepare to implement and follow them.
* OPOs should determine who may be affected by school closures and who would have the capacity (both physical and infrastructural - i.e. phone, internet, and computer access) to work from home.
* OPOs should determine which staff members are eligible for seasonal influenza vaccine and influenza A (H1N1) 2009 monovalent vaccine and how these will be provided for (influenza A (H1N1) 2009 monovalent vaccine , for example, may require registration with the local health department for health care organizations).

Future updates will be posted to the newsroom section of the OPTN and UNOS Web sites. Also refer to these online resources for related information and developments regarding the pandemic:

* http://www.cdc.gov/h1n1flu
* http://www.flu.gov
* http://www.a-s-t.org/files/pdf/ast_h1n1_guidance.pdf
* http://www.ishlt.org
* http://www.transplantation-soc.org/downloads/AST%20TTS%20H1N1%20Guidance%20Document%20disclaimer%209-22-09%20PDF%20FINAL.pdf

http://www.unos.org/news/newsDetail.asp?id=1292