Quality Management Issues in the Assisted Reproduction Laboratory

Abstract

In the United States, the Clinical Laboratory Improvement Act (CLIA) of 1988 describes requirements and guidelines for implementing a quality control/quality assurance (QC/QA) program for moderate and high complexity laboratories. These requirements and guidelines apply to Assisted Reproductive Technology (ART) laboratories as well. The general topic of QC and QA as it pertains to in vitro fertilization (IVF) and embryo transfer (ET) is extensively reviewed. This review summarizes many of the QC and QA events that contribute to the advancement of knowledge in this biotechnological field. These events include control of the culture environment inside and outside of the incubator, as well as factors that affect culture media. This review also discusses, in considerable detail, the QC and the QA that pertain to equipment used within the laboratory and how to control for potential contaminants, which reside within the laboratory. This review provides evidence to indicate the need for laboratory personnel to monitor quality improvement issues on a continuous basis. Personnel must be willing to change as improvements in technology occur in order to meet the ever-evolving demands of a more difficult patient population. Suggestions for meeting these demands are offered.

How to Reduce the Potential Harmful Effects of Light on Blastocyst Development during IVF

“…Although IVF has revolutionized infertility treatment, during manipulation the embryo is subjected to environmental stressors [28][29][30]. Our maximal care about the lighting applied in IVF and ICSI procedures is expected to ensure a safe environment.…”

Volatile organic compounds and good laboratory practices in the in vitro fertilization laboratory: the important parameters for successful outcome in extended culture

“…Not only the main IVF laboratory room but also the adjacent areas like ICSI room, operation theater, and changing room play an important role. So, it is important to design laboratory cautiously [31]. It was observed in a study that Boosafe^had no deleterious effect on gametes and embryos and was better compared to alcohol which itself is a VOC [20,32].…”

“…The mean 95% confidence interval between the two groups during morning is 16.271 and interval of difference between them is 14.106 to18.437. The mean 95% confidence interval between the two groups during evening is 13.057 and interval of difference between them is 11.571 to 14.543 practices in comparison to before renovation; so, the quality of embryos improved [21].VOCs may significantly affect the embryo quality [1] and proper design of the laboratory is essential [31]. Air quality conditions were better in the new site and were associated with higher blastocyst formation, implantation, and live birth rates in couples undertaking treatment in our new facility.…”

The heat is on: room temperature affects laboratory equipment–an observational study

“…Temperature is an essential component of cellular physiology and a critical aspect of embryo culture [1]. It is well documented in the literature that temperature stability is necessary during in vitro fertilization (IVF) [2,3]. In many species such as rabbit [4], bovine [5,6], mouse [3,7], rat [8,9] and human [2,3,[10][11][12] in vitro exposure to anomalous temperatures affects gamete competency, embryo development, and offspring survival.…”

“…Because temperature can influence in vivo and in vitro reproduction, temperature control is vital in assisted reproduction to ensure that no gametes or embryos are exposed to extreme temperature fluctuations. Stringent temperature control is essential not only during embryo culture, but also during manipulation of gametes and embryos [2,3]. Incubators, microscope heating stages, slide warmers, and heating blocks must all be calibrated and monitored regularly during use [2,3] to avoid unnecessary exposure of gametes and embryos to detrimental conditions.…”