Is azoospermia the appropriate standard for post-vasectomy semen analysis? Or an unachievable goal of best practice laboratory guidelines.
TL;DR: Attempts to improve detection of occasional non-motile sperm are futile, cost more and fail to reduce risk of inappropriate clearance, with uncertainty surrounding the diagnosis, this study describes the analysis of 10 years of PVSA.
Abstract: The increasingly stringent laboratory-approach to diagnosing azoospermia for post-vasectomy semen analysis (PVSA) continues to be at odds with the simpler approach desired by clinicians. This study describes the analysis of 10 years of PVSA and discusses the outcome in relation to risk, cost and assesses whether more stringent procedures are required. PVSA was performed on 4788 patients initially using a 2-test strategy (16 and 20 weeks post-surgery), moving to 1 test during 2013-2014. Azoospermia was confirmed by the analysis of 10 µl of semen followed by 10 µl of centrifuged pellet. In total, there were 9260 tests with a median of 1.93 tests/patient and 18.7 weeks to clearance. Surgical failure occurred in 1.75%, falling to 1.1% between 2011 and 2016. There were no cases of unwanted pregnancy, recanalization or complaints although misdiagnosis was detected in 1 case as a result of failure to confirm patient identification. Azoospermia performed according to World Health Organization (WHO) guidelines is sufficiently robust to confirm success/failure of vasectomy. With uncertainty surrounding the diagnosis, efforts to improve detection of occasional non-motile sperm are futile, cost more and fail to reduce risk of inappropriate clearance. Misdiagnosis is more likely from patient identification error and mitigation may include reverting to the safety net of a 2-test strategy.
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TL;DR: The ability by participants to monitor spermatogenesis suppression to a threshold compatible with contraceptive efficacy utilizing a user-controlled test verified by sperm concentration determined by standard laboratory methods is discussed in this article .
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TL;DR: The large heterogeneity of literature on laboratory errors together with the prevalence of evidence that most errors occur in the preanalytical phase suggest the implementation of a more rigorous methodology for error detection and classification and the adoption of proper technologies for error reduction.
Abstract: Background: The problem of medical errors has recently received a great deal of attention, which will probably increase. In this minireview, we focus on this issue in the fields of laboratory medicine and blood transfusion.
Methods: We conducted several MEDLINE queries and searched the literature by hand. Searches were limited to the last 8 years to identify results that were not biased by obsolete technology. In addition, data on the frequency and type of preanalytical errors in our institution were collected.
Results: Our search revealed large heterogeneity in study designs and quality on this topic as well as relatively few available data and the lack of a shared definition of “laboratory error” (also referred to as “blunder”, “mistake”, “problem”, or “defect”). Despite these limitations, there was considerable concordance on the distribution of errors throughout the laboratory working process: most occurred in the pre- or postanalytical phases, whereas a minority (13–32% according to the studies) occurred in the analytical portion. The reported frequency of errors was related to how they were identified: when a careful process analysis was performed, substantially more errors were discovered than when studies relied on complaints or report of near accidents.
Conclusions: The large heterogeneity of literature on laboratory errors together with the prevalence of evidence that most errors occur in the preanalytical phase suggest the implementation of a more rigorous methodology for error detection and classification and the adoption of proper technologies for error reduction. Clinical audits should be used as a tool to detect errors caused by organizational problems outside the laboratory.
758 citations
TL;DR: This guideline was peer reviewed by 55 independent experts during the guideline development process and recommended that vasectomy be considered for permanent contraception much more frequently than is the current practice in the U.S. and many other nations.
157 citations
TL;DR: Technology, ranging from bar-coded specimen labels to radio frequency identification tags, can be incorporated into protective systems that have the potential to detect and correct human error and reduce the frequency with which patients and specimens are misidentified.
109 citations
TL;DR: There were six cases of late recanalisation in men previously thought sterile by two consecutive azoospermic analyses 4 months after vasectomy, not influenced by the operative technique used, but varied markedly between individual surgeons.
Abstract: Sixteen thousand, seven hundred and ninety-six men underwent vasectomy between 1970 and December 1983 and have been reviewed. Post-operative side effects were few and significant complications were reported in 0.9%. Failure to achieve sterility occurred in 72 men, 69 of whom have been analysed. The early recanalisation rate was 0.36%. This rate was not influenced by the operative technique used, but varied markedly between individual surgeons. Experience and care with technique should result in a failure rate of 0.2% or better. There were six cases of late recanalisation in men previously thought sterile by two consecutive azoospermic analyses 4 months after vasectomy.
108 citations
TL;DR: The novel CASA system was able to provide semen quality measurements for sperm concentration and motility measurements which were at least as reliable as current manual methods.
76 citations