Physical examination of potential tissue donors: results of a risk management procedure to identify the critical elements of the physical examination

Abstract

To identify critical elements of physical examination (PE) of potential tissue donors that could help to improve the safety of tissue transplantation. Physical signs were identified that can indicate the presence of a contraindication mentioned in EU Directive 2006/17/EC and that can theoretically be detected at PE. A risk assessment was designed, according to the Failure Mode and Effects Analysis model. Signs were scored on several aspects, taking into account various control measures, either required in the EU Directive or additional non-required measures. 106 signs associated with general and tissue-specific contraindications were identified. Signs of advanced infection with HIV, hepatitis B/C and syphilis (n = 13, 12.3%) can be omitted, since these contraindications will be detected by the required serological testing. With the required control measures, risk priorities are unacceptably "high" for 17.3% of the signs. For 64.5% of the signs, additional control measures are possible, which result in acceptable risk priorities for all signs. This risk management procedure identified the minimal necessary content of PE in potential tissue donors. Furthermore, risks associated with tissue donation were elucidated and possible risk control measures were identified as well as their impact on the safety of tissue transplantation.

An Integrative Review of the Physical Examination Performed on Deceased Potential Organ and Tissue Donors

“…The Government of Canada Guidance Document for Cell, Tissue and Organ Establishments—Safety of Human Cells, Tissues and Organs for Transplantation 12 highlights that potential donor high-risk physical examination findings may not necessarily preclude donation but rather aid in important clinical decision-making. Only 2 of the articles include how to document physical examination findings, in terms of explaining observations, rather than diagnostic interpretation.…”

“…All but one of the articles mention in varying detail, physical examination indicators of higher risk to recipients, including the presence of jaundice, tattoos, body piercings, nonmedical injection sites, signs of sexually transmitted infections, scars, oral thrush, and skin lesions. [4][5][6][7][8][9][10][11][12][13][14][15][16] Two of the 14 articles included pictures and descriptions of abnormal physical examination findings indicative of potential risk. 7,15 In respect to tissue only donation, physical signs are often associated with 20 of 22 general contraindications to donation.…”

“…14 The article also suggests that as routine donor serological testing detects advanced infection with HIV, Hepatitis B and C, and syphilis, the need to assess the donor for the physical signs of these conditions is eliminated. 14 Additionally, the Government of Canada Guidance Document for Cell, Tissue and Organ Establishments-Safety of Human Cells, Tissues and Organs for Transplantation 12 refers to the remote possibility of recent smallpox immunization as a risk for disease transmission in a small portion of the population.…”

“…13 Tissues were discarded after physical examinations revealed evidence of skin lesions, anal lesions, or enlarged lymph nodes, which were found to be occult cancers in the breast, lymph node, or skin, or suggestive of infectious granulomatous disease. 13 The Government of Canada Guidance Document for Cell, Tissue and Organ Establishments-Safety of Human Cells, Tissues and Organs for Transplantation 12 highlights that potential donor high-risk physical examination findings may not necessarily preclude donation but rather aid in important clinical decision-making. Only 2 of the articles include how to document physical examination findings, in terms of explaining observations, rather than diagnostic interpretation.…”

Regulatory Anatomy

“…When a tissue bank receives a full cadaver for multiple tissue recovery it might seem a straightforward matter to conduct a “physical examination,” but what should you look for? It has been suggested to search bodies for tattoos, recent piercings, or signs of anal intercourse, even though identification of the latter lacks established criteria ( Van Wijk et al 2012 ). It gets more complicated when, for example, bone is harvested from living donors, which is the case of patients undergoing a prosthetic device operation.…”