Systemic Tissue Tracking Deficiencies Remain a Serious Threat to Patient Safety
Systemic Tissue Tracking Deficiencies Remain a Serious Threat to Patient Safety
The Joint Commission established standards for the handling of tissues for allograft procedures in 2005 (Meeting JCAHO's new tissues standards, 2005). The three main areas of concern were creating a standardized process for handling tissues, investigating adverse events, and tracking the tissue from donor to recipient. The details of these rules can be found on the website for the U.S. Food and Drug Administration (FDA, 2013). The International Council for Commonality in Blood Banking Automation (ICCBBA, 2013) has produced a set of international coding standards for medical products derived from humans, including blood, tissues, organs, milk, cellular therapy products, and plasma products that must be ABO typed before use. These standards are used in more than 75 nations on six continents (ICCBBA, 2013). Government and healthcare provider accrediting agencies are therefore allocating significant resources to the issue of tissue tracking. For example, a Joint Commission survey of the Charleston Area Medical Center in Charleston, West Virginia in 2006 investigated every step of the tissue tracking procedures the hospital used, from arrival to storage to peri-surgical entry into the patient's chart (Tissue tracking requirements, 2007).
In light of a health system-wide push to improve patient safety and reduce the cost of healthcare services, it seems unlikely that the many rules and regulations governing the allograft documentation trail are frivolous. To better understand the rationale behind these rules and regulations, the research literature, policy statements, and professional opinions relevant to this topic will be reviewed here.
What Can Go Wrong?
In 2011, the U.S. Centers for Disease Control and Prevention (CDC) issued a report revealing weaknesses in the donor to recipient tissue transplantation process. A Kentucky male resident was killed during an all-terrain vehicle accident and 43 musculoskeletal and 1 cardiopulmonary patch grafts were distributed to hospitals across several states. Donor screening by the procurement organization and tissue bank failed to detect hepatitis C using an antibody test, and even though the nucleic acid test was positive the technician read it as negative. A patient history was developed, relying in part on the father, but a subsequent investigation revealed the son had been distant from the father during the last year of his life.
Current best practice recommendations are provided by the FDA and the Organ Procurement and Transplantation Network (CDC, 2011). Testing of solid organs requires an antibody test, while all other human-derived products require both antibody and nucleic acid testing. The investigation into the Kentucky event relied on nucleic acid testing, which revealed the mistakes. Adding to the complexity of the investigation was the fact that the donor had received six units of blood as a hospital inpatient six months before his death. During the investigation the remaining unused units were quarantined pending additional testing. In the meantime, three Kentucky residents received the donor's liver and two kidneys and within six months the kidney recipients began to develop elevated liver enzymes. As the kidney recipients were beginning to show the signs of a hepatitis C infection, a cardiopulmonary patch from the same donor was implanted into a Massachusetts resident. About a month later, the heart recipient tested positive for hepatitis C The liver recipient had tested positive for hepatitis C prior to surgery, so no further testing was performed on this patient. Subsequent phylogenetic testing supported the conclusion that the donor was the most likely source of the hepatitis C infections for the kidney and cardiopulmonary patch recipients.
The CDC (2011) investigation revealed both the mistakes made during donor screening, but also the mistakes made during testing of the donated tissues and organs. Under Organ Procurement and Transplantation Network guidelines, only antibody testing was recommended. The CDC relied on the nucleic acid test to confirm hepatitis C positivity for the donor, recipient transplant patients, and organs and tissues still archived at the tissue bank; therefore, there is a weakness in recommended testing procedures for solid organs. The CDC investigation also revealed significant delays in the testing and notification procedures the procurement organization was using. In addition, a recent study revealed that it took an average of 13 days for the CDC to locate and notify the surgeons who had transplanted the tissues and 29 days to locate, inform, and test the recipients (Mahajan & Kuehnert, 2013). If the system had been more efficient, one or more hepatitis C infections may have been prevented.
The Chief Policy Officer of the American Association of Tissue Banks, Scott Brubaker (2010), listed several other incidents when tissue tracking failed to live up to expectations. Donor screening in 1991 failed to detect HIV in a donor from 1985 and 53 tissue grafts and 4 organs were distributed. Five of the tissue grafts could not be located by the hospitals that received them. When a more sensitive hepatitis C antibody test was marketed in 1992, a tissue bank began retesting tissues and organs and identified 3 donors testing positive. Of the 29 grafts distributed, 2 remained unaccounted for by the 2 hospitals that received them. In 2002, 7,856 tissues were recalled due to validation errors and 359 could not be located by the receiving hospitals or there was no response. During 2005 and 2006, 2,000 out of 28,000 tissue grafts and devices could not be immediately located by the recipient healthcare organizations. In 2006, 4,805 tissue grafts were recalled by a distributor due to Chryseobacterium menigosepticum contamination. Over 750 hospitals in the U.S., Canada, and Mexico were affected by the recall and 6 grafts could not be accounted for until the FDA stepped in.
In addition to the risk of viral transmission and bacterial contamination, tissue and organ transplants can be vectors for parasites, prions, malignancies, and toxins (Strong & Shinozaki, 2010). The amplification potential is significant, since single donor may sometimes be the source of up to 100 tissues and organs. In 2005, 7 organs, 2 corneas, and 82 other tissues were obtained from a donor with hepatitis C (Strong & Shinozaki, 2010). These organs and tissues were distributed to multiple tissue banks, who then distributed tissues and organs to providers in 16 states and 3 countries. Of the 40 transplant patients who received tissues and organs from this donor, 7 were subsequently found to be hepatitis C positive. All of the hepatitis C seroconversions in the tissue recipients could have prevented by an efficient tissue tracking infrastructure, because six months elapsed between positive testing of the organ recipients and the release of allografts from the tissue banks.
Brubaker (2010) concluded that there has been little improvement in tissue tracking procedures over the past twenty years, although tissue banks were able to identify the recipients in 100% of the cases; however, hospitals could not make the same claim. Brubaker (2010) also noted that the speed of recalls is not being documented. These deficiencies in the tissue tracking process are particularly relevant today since the amount of donor tissue being made available has doubled over the past 20 years (Mahajan & Kuehnert, 2013). When combined with the potential amplification of a threat to patient safety due to a single donor providing multiple tissues and organs, the threat to patient safety may have also doubled. The magnitude of the problem is highlighted by the fact that between 1994 and 2007 the FDA recalled 61,607 tissue allografts (Strong & Shinozaki, 2010). The tissue tracking deficiencies in hospitals ranged between 2.5 and 9.0%, based on the data reviewed by Brubaker (2010). If these percentages were applied to the FDA recall statistics, between 1,540 to 5,545 donated tissues were probably unaccounted during this period. The risk to patient safety is very real indeed.
The main deficiencies existing in the donor-recipient pathway are testing sensitivity and accuracy, poor documentation by end-users, and notification delays by tissue/organ procurement agencies and surgical departments. The problem statement being considered here is not focused on testing accuracy, only tissue tracking deficiencies. Giachetta-Ryan (2008) listed the main state regulatory requirements typically required for tissue transplantation facilities, including surgical departments. These are documenting: (1) source tissue bank, (2) tissue description, (3) tissue serial or ID number, (3) condition of tissue upon arrival, (4) and recipient. The Association of periOperative Registered Nurses also recommends the following: (1) obtain tissues only from FDA and state licensed tissue banks (2) designation of a single tissue tracking manager, and (3) storage per recommendations. These are the minimum recommended steps, but Giachetta-Ryan (2008) highlighted a tissue accounting protocol adopted by an institution that mandated daily counts of tissues, in addition to daily checks of storage temperatures. This strategy decreases the risk of a discrepancy going unnoticed for more than 24 hours and improves an investigation outcome because staff memories will still be fresh.
While these rules, regulations, and recommendations will help protect patient safety, the CDC and FDA investigations revealed they are not enough bring the risk of transmission or…