1. INTRODUCTION
1.1 This policy provides guidance on the management of potential organ/tissue donors with positive virology results. It will give healthcare professionals guidance on how to proceed when donation cannot take place as a consequence in light of these results, the subsequent care of the potential donor, and their next of kin/significant other.
1.2 Transplantation is now well established, as the treatment of choice for the majority of patients with end stage organ failure. However, the transmission of infection is one of the associated risks. All potential organ/tissue donors have blood taken for a number of virology tests. Please refer to the Microbiological Safety of Blood and Tissues for Transplantation (MSBT) guidelines.1 In addition, the donor/tissue transplant co-ordinator is required to take a detailed medical and social history.
1.3 When organ donation is discussed with the family of the potential donor, and consent for donation is agreed, this process also informs the donor’s family that tests for a the consent will include testing for a number of possible viral infections. will be carried out on the blood of the potential donor. Moreover, the consent form also says that in the event of a confirmed positive result becoming available that may have clinical relevance to any family member, then the result and its implications will be discussed with them.
1.4 Confidentiality is one of the most significant concepts in healthcare and is an important factor in client/practitioner relationships as stated in the codes of conduct (General Medical Council (GMC) 19932 /Nursing Midwifery Council 2002).3
1.5 Under The NHS (Venereal Diseases) Regulation 19744 and the NHS Trusts (Venereal Diseases) Directions 19915 it:
“prevents the disclosure of any identifying information about a patient examined or treated for a sexually transmitted disease (including HIV & AIDS) other than to a medical practitioner (or to a person employed under the direction of a medical practitioner) in connection with and for the purpose of whether the treatment of the patient and/or the prevention of the spread of the disease.”
This regulation demonstrates that there are statutory duties to ensure all steps are taken to prevent any information, that is capable of identifying a patient with a sexually transmitted disease being disclosed. However the disclosure of this information could arguably be possible for the purposes of treatment and prevention of the spread of the disease to partners and others who may be affected as a result of their relationship to the potential organ donor.
1.6 This Policy has been devised to provide guidelines, information and support for healthcare professionals where positive virology results have been confirmed on potential organ/tissue donors and where these results have implications for others. It is important that this is dealt with in an appropriate manner pertinent to the merit of each individual case.
2. REVIEW
2.1 This document will be reviewed every two years or as required.
3. AIM
3.1 To identify all potential donors with positive virology
3.2 To determine the necessity for disclosure of this information to the next of kin/significant other.
3.3 To obtain expert advice.
3.4 To repeat and confirm virology results.
3.5 To determine who discloses this information.
3.6 To disclose the findings with the appropriate healthcare specialists.
3.7 To ensure that any discussions with the next of kin/significant other are appropriately documented in the potential organ/tissue donor’s medical notes.
3.8 To ensure documentation of reasons for disclosure are clear and concise including contact/advise given from appropriate individual healthcare professionals.
3.9 Disclosure to take place within an appropriate time scale.
3.10 To advise the next of kin/significant other of support networks available.
4. RATIONALE
4.1 It is acknowledged that in the UK there is no current legislation regarding the breach of confidentiality when disclosing positive virology results of potential cadaver donors (especially when a third party health is at risk). In contrast there are many states in America where there is a legal obligation to disclose confidential information if there is a third party who may be affected (Cochran 1999).6
4.2 The British Medical Association (BMA) Confidentiality and Disclosure of Health Information document (1999)7 states:
‘post mortem test of a cadaver may reveal the presence of previously undiagnosed infectious conditions which people close to the deceased person may need to be aware of in order to protect their own health or that of others’
4.3 The ethos of the Department of Health (DOH), BMA and GMC is that the decision to disclose information regarding positive virology results should be made by balancing the benefits with the harm of the public interest. This includes the legitimate concern for the interests of others who may be affected by the person with the virus. The GMC (1993) has concluded:
‘there are grounds for such disclosure only where there is a serious and identifiable risk to a specific individual who, if not so informed, would be exposed to the infection………………………but where such consent is withheld the doctor may consider it a duty to seek to ensure that any sexual partner is informed, in order to safeguard such persons from a possible fatal infection’ (GMC cited in Kennedy, Chapter 9, pg 6648).
4.4 The DOH issued guidance on partner notification for HIV in December 19929 and stated that the benefits of notification are the following:
q Identified contacts are given the opportunity to consider whether they wish to be tested
q Those who have unknowingly been infected may wish to take steps to prevent transmission to others
q Access to treatment and support programmes so that they may benefit from long term monitoring of their clinical condition and from appropriate therapies.
4.5 Although the above guidance has only stipulated the disclosure for HIV infection, Hepatitis B and C are important viruses and the implications of such infections can be equally as life threatening as HIV. These guidelines therefore may be used to address all positive virology results where there are implications for a third party.
4.6 Informing potentially infected individuals may have various implications. However, advances in medical treatments, therapies and support networks may balance the benefit and outweigh the harm for most individuals.
4.7 A nationwide policy will give guidance to the healthcare professionals in dealing with this ethically and morally difficult issue.
5. HIV
5.1 When a potential organ/tissue donor has been identified as HIV positive this information will be relayed to the duty donor/tissue transplant co-ordinator.
5.2 The donor/tissue transplant co-ordinator will stop the donation process, informing all the relevant parties but maintaining the need for confidentiality.
5.3 The result will be reconfirmed by the laboratory medical staff prior to disclosure.
6. HEPATITIS B/C
6.1 When a potential organ/tissue donor has been identified as hepatitis positive this information will be relayed to the donor/tissue transplant co-ordinator.
6.2 The donor/tissue transplant co-ordinator will inform UKT and the relevant retrieval teams of the result.
6.3 If the retrieval teams decline the offer the donor transplant co-ordinator will inform UKT. The organs will continue to be offered in accordance with national guidance.
6.4 This result will be reconfirmed by the laboratory medical staff prior to disclosure
7. SYPHILIS
7.1 On obtaining a positive syphilis result the donor/tissue transplant co-ordinator will inform the transplant team and UKT, as appropriate.
7.2 This result will be reconfirmed by the laboratory medical staff prior to disclosure.
8. NOTIFICATION OF NEXT OF KIN/SIGNIFICANT OTHERS
8.1 The donor/tissue transplant co-ordinator will discuss with the clinician in charge of the potential donor an action plan on what information is to be disclosed to the next of kin/significant other at this early stage and how this information will be disclosed and by whom.
8.2 An appointment will be arranged to discuss results with the next of kin/significant other, however, this should take place after the confirmatory results have been received and expert advice has been obtained.
8.3 The clinician in charge of the care of the potential donor should be involved in this meeting and it may be appropriate to include an expert practitioner within this field. This meeting should include no less than two appropriate healthcare professionals. Advice may be obtained from the hospital legal department and the medical director of UKT before any meeting takes place if necessary.
8.4 The information to be discussed at this meeting should include:
- A detailed discussion of the positive result and the implications to the next of kin/significant other
- An offer to screen all those who may be at risk
- The need for precautions to be taken until their results are confirmed. If they decline to be tested then advice should be given on prevention of transmission.
- Approval should be sought and encouraged for permission to divulge these findings to their General Practitioner.
- Contact numbers for local clinics and support groups/counsellors should be given to the next of kin/significant other.
8.5 Detailed records of all conversations should be entered into the notes of the potential donor/ donor medical records.
8.6 Letter should be sent to the General Practitioner of the potential donor/donor.
REFERENCES
1 Department of Health, Advisory Committee on the Microbiological Safety of Blood and Tissues for Transplantation.Guidance on the Microbiological Safety of Human Organs, Tissues and Cells used in Transplantation (August 2000).
2 General Medical Council (1993) Confidentiality: Protecting and Providing Information
3 Nursing and Midwifery Council (2002) Code of Professional Conduct
4 The National Health Service (Venereal Diseases) Regulation 1974, No 29
5 The National Health Service Trusts (Venereal Diseases) Directions 1991
6 Cochran M (1999) The real Meaning of Patient-Nurse Confidentiality, Critical Care Nurse Quarterly 22 (1) pp 42-51
7 British Medical Association (1999) Confidentiality and Disclosure of Health Information
8 Kennedy I, Grubb A (1994) Medical Law, Chapter 9, pg 664, 2nd Edition, Butterworth & Co Ltd, London
9 Department of Health (1992) PLICO (92) 5 Guidance on Partner Notification for HIV Infection
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