Comprehensive protocol of traceability during IVF: the result of a multicentre failure mode and effect analysis.

STUDY QUESTION: Can traceability of gametes and embryos be ensured during IVF? SUMMARY ANSWER: The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. WHAT IS KNOWN ALREADY: Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment. A clear process of patient and cell identification involving witnessing protocols has to be in place in every unit. To identify potential failures in the traceability process and to develop strategies to mitigate the risk of mismatches, previously failure mode and effects analysis (FMEA) has been used effectively. The FMEA approach is however a subjective analysis, strictly related to specific protocols and thus the results are not always widely applicable. To reduce subjectivity and to obtain a widespread comprehensive protocol of traceability, a multicentre centrally coordinated FMEA was performed. STUDY DESIGN, SIZE, DURATION: Seven representative Italian centres (three public and four private) were selected. The study had a duration of 21 months (from April 2015 to December 2016) and was centrally coordinated by a team of experts: a risk analysis specialist, an expert embryologist and a specialist in human factor. Principal investigators of each centre were first instructed about proactive risk assessment and FMEA methodology. A multidisciplinary team to perform the FMEA analysis was then formed in each centre. After mapping the traceability process, each team identified the possible causes of mistakes in their protocol. A risk priority number (RPN) for each identified potential failure mode was calculated. The results of the FMEA analyses were centrally investigated and consistent corrective measures suggested. The teams performed new FMEA analyses after the recommended implementations. PARTICIPANTS/MATERIALS, SETTING, METHODS: In each centre, this study involved: the laboratory director, the Quality Control & Quality Assurance responsible, Embryologist(s), Gynaecologist(s), Nurse(s) and Administration. The FMEA analyses were performed according to the Joint Commission International. MAIN RESULTS AND THE ROLE OF CHANCE: The FMEA teams identified seven main process phases: oocyte collection, sperm collection, gamete processing, insemination, embryo culture, embryo transfer and gamete/embryo cryopreservation. A mean of 19.3 (SD ± 5.8) associated process steps and 41.9 (SD ± 12.4) possible failure modes were recognized per centre. A RPN ≥15 was calculated in a mean of 6.4 steps (range 2-12, SD ± 3.60). A total of 293 failure modes were centrally analysed 45 of which were considered at medium/high risk. After consistent corrective measures implementation and re-evaluation, a significant reduction in the RPNs in all centres (RPN <15 for all steps) was observed. A simple and comprehensive traceability system was designed as the result of the seven FMEA analyses. LIMITATIONS, REASONS FOR CAUTION: The validity of FMEA is in general questionable due to the subjectivity of the judgments. The design of this study has however minimized this risk by introducing external experts for the analysis of the FMEA results. Specific situations such as sperm/oocyte donation, import/export and pre-implantation genetic testing were not taken into consideration. Finally, this study is only limited to the analysis of failure modes that may lead to mismatches, other possible procedural mistakes are not accounted for. WIDER IMPLICATIONS OF THE FINDINGS: Every single IVF centre should have a clear and reliable protocol for identification of patients and traceability of cells during manipulation. The results of this study can support IVF groups in better recognizing critical steps in their protocols, understanding identification and witnessing process, and in turn enhancing safety by introducing validated corrective measures. STUDY FUNDING/COMPETING INTEREST(S): This study was designed by the Italian Society of Embryology Reproduction and Research (SIERR) and funded by the Italian National Transplant Centre (CNT) of the Italian National Institute of Health (ISS). The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: N/A.

Urgent lung transplantation national program: the Italian experience.

INTRODUCTION: An urgent lung transplantation national program in Italy was developed over the past three years. Indispensable conditions that were included in the program were invasive respiratory support and/or extracorporeal vascular device (DECAP excluded). The aim of this study was to test the effectiveness of the program. MATERIALS AND METHODS: We analyzed urgent lung requests received between 2009 and 2011 taking into account primary pathology, request outcome, average waiting time, and organ origin. Taking as reference the same period of time, we also examined the ordinary waiting list, waiting list mortality, and number of transplantations performed and we have compared them with another three-year period prior to the activation of the program. RESULTS: The total number of urgent requests was 43. Primary pathologies with the highest incidence proportion were cystic fibrosis (40%) and idiopathic pulmonary fibrosis (26.6%). A total of 34 requests (79%) were successfully dealt with and 9 of them were suspended because of worsening conditions. The average waiting time was 17.9 days. During the same period of time 340 lung transplantations were performed and there were 499, 524, and 564 wait-listed patients in 2009, 2010, and 2011, respectively. The mortality rate was 21.3%. Over the previous three-year period 295 transplantations were performed and there were 457, 476, and 464 wait-listed patients in 2006, 2007, and 2008, respectively. Also the mortality rate was 25.3%. DISCUSSION: Urgent lung transplantations can provide patients in an imminent life-threatening situation with adequate care without affecting the mortality rate of patients on the ordinary waiting list.

Report of four simultaneous pancreas-kidney transplants in HIV-positive recipients with favorable outcomes.

The advent of combined antiretroviral therapy (cART) dramatically changed the view of human immunodeficiency virus (HIV) infection as an exclusion criterion for solid organ transplantation, resulting in worldwide reports of successful transplants in HIV-infected individuals. However, there are few reports on simultaneous pancreas-kidney transplant in HIV-positive recipients detailing poor outcomes. A series of four pancreas-kidney transplant performed on HIV-infected individuals between 2006 and 2009 is presented. All recipients reached stably undetectable HIV-RNA after transplantation. All patients experienced early posttransplant infections (median day 30, range 9-128) with urinary tract infections and bacteremia being most commonly observed. In all cases, surgical complications led to laparotomic revisions (median day 18, range 1-44); two patients underwent cholecystectomy. One steroid-responsive acute renal rejection (day 79) and one pancreatic graft failure (month 64) occurred. Frequent dose adjustments were required due to interference between cART and immunosuppressants. At a median follow-up of 45 months (range, 26-67) we observed 100% patient survival with CD4 cell count >300 cells/mm(3) for all patients. Although limited by its small number, this case series represents the largest reported to date with encouraging long-term outcomes in HIV-positive pancreas-kidney transplant recipients.

West Nile virus: the Italian national transplant network reaction to an alert in the north-eastern region, Italy 2011.

We report four cases of West Nile virus (WNV) transmission following a single multiorgan donation in north-eastern Italy. The transmissions were promptly detected by local transplant centres. The donor had been tested for WNV by nucleic acid amplification test (NAT) prior to transplantation and was negative. There were no detected errors in the nationally implemented WNV safety protocols.

Alpine skiing and anaerobic performance in solid organ transplant recipients.

Limited information has been published about sporting activities in solid organ transplant recipients. The aim of this study was to assess "in the field" performance capacities of a group of transplant recipients involved in an alpine skiing competition. We studied 16 transplant recipients (13 men and 3 women) who had undergone transplantations (11 kidney, 4 liver, and 1 heart) at 89 +/- 68 months prior while participating in an alpine skiing race. The patients performed a countermovement jumping test to measure the explosive power of the lower limbs. In all patients blood lactate concentrations (La) were measured at the end of a giant slalom race. The maximum displacement of the center of mass during the jumping test was 22.4 +/- 9.3 cm; the time to complete the giant slalom was 75.5 +/- 16.5 seconds and La was 3.5 +/- 0.8 mmol/L. We observed significant linear relationships between race time and La (R(2) = 0.4733; P < .01) and between race time and performance in the jumping test (R(2) = 0.3655; P < .05). This study indicated that recovery of anaerobic and technical sporting activities is possible in organ transplant recipients. Muscular power and anaerobic performances among a selected group of solid organ transplant recipients were similar to those of the general untrained population.

Incidence and timing of infections after liver transplant in Italy.

BACKGROUND: Infections are one of the main complications that cause high morbidity and mortality in transplant recipients. This study sought to estimate the incidence of infections and their main determinants in liver transplant recipients in the first year after transplantation. PATIENTS AND METHODS: A prospective study was conducted on 103 consecutive patients (72% men) who underwent transplantation in three centers in Northern (Bologna) and Central (Rome) Italy in 2005. Person-years (PY) at risk, incidence rates (IR), IR ratios and 95% confidence intervals were computed for viral, fungal, and bacterial infections. RESULTS: The 103 patients (median age 55 years) contributed a total of 78.2 PYs, with a median follow-up of 286 days (interquartile range: 194 to 365 days). Fifty-eight patients (56.3%) experienced one or more infections, namely, 151 events (IR = 193.2 infections/100 PYs). IR for bacterial, fungal, and viral infections were 110.0, 56.3, and 26.9 infections/100 Pys, respectively. Within the first 30 days after transplantation, 37.9% patients (39/103) developed one or more events. Bacterial infections represented the most frequent event (86/151, 57.0%). Risk factors significantly associated with increased IR were gender (female), age (>50 years), prolonged intensive care stay volume of blood transfused during surgery and posttransplant, and need for retransplantation. CONCLUSIONS: These preliminary results showed the relevance of infectious events after liver transplantation especially those of bacterial etiology, and identified factors mainly associated with their occurrence.

Role of simian virus 40 in cancer incidence in solid organ transplant patients.

Transplant recipients have an increased risk of developing cancer in comparison with the general population. We present here data on cancer development in transplanted subjects who received organs from donors whose DNA was previously examined for the genomic insertion of Simian Virus 40 (SV40). Active follow-up of 387 recipients of solid organs donated by 134 donors, not clinically affected by cancer, was performed through the National Transplant Center (NTC). The average length of follow-up after transplant was 671+/-219 days (range 0-1085 days). Out of 134 proposed donors, 120 were utilised for organ donation. Of these, 12 (10%) were classified as positive for SV40 genomic insertion. None of the 41 recipients of organs from SV40 positive donors developed a tumour during the follow-up. In all, 11 recipients of organs given by SV40 negative donors developed a tumour (cancer incidence: 0.015 per year). In conclusion, cancer rates observed in our study are comparable to what reported by the literature in transplanted patients. Recipients of solid organs from SV40 positive donors do not have an increased risk of cancer after transplant. The role of SV40 in carcinogenesis in transplanted patients may be minimal.