Quality Control Of Embryo In Human In In-Vitro Fertilization Article Review
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Good quality of “In-vitro fertilization” (IVF) clinics is important for the welfare and health of patients and offspring. This good quality is represented by the staff, equipments, procedures, and laboratory designs. For “Assisted Reproductive Technology” (ART), “standard operating procedures” (SOPs) and “Quality management systems” (QMT) can be applied. To achieve these procedures and systems, “quality control” (QC) and “quality assurance” (QA) can help. On a further note, “total quality improvement” (TQI) is also important as it can help in comprehensive monitoring and elimination of problems along with the innovation and development of flexible as well as effective solutions to the problems. Some important indicators of good laboratory performance are oocyte and sperm collection, preparation of gamete, sample identification, fertilization and cleavage, cryopreservation, transfer of embryo in the body, report of laboratory and its safety, and outcomes of the procedures. TQI program along with QA and QC deal with all these indicators and help to improve patient care as well as satisfaction in the IVF setting.
Review Article # 1
In the article “Quality management systems for your in vitro fertilization clinic's laboratory: Why bother?”1 Orofsson et al. have noted the important points of quality management in In-vitro fertilization (IVF) clinics. Authors have also described the characteristics of the patient-centered optimal IVF laboratory. In the described characteristics, the authors have noted that good quality of IVF clinics encompasses many concepts ranging from efficacy of treatment to the impact on health and welfare of patients and offspring. They have told that the people, equipment, procedure, and the laboratory design are important components of quality laboratory. People with proper education and training are important for the good quality of an IVF center. Procedures done by the staff of IVF clinic must have maximum chances of success and minimum chances of unlikely responses. All kinds of consumable products that can come in direct contact with patients and embryos must be non-toxic. Recording of all documentation and data is important and this can be done according to the standard operating procedures (SOPs). Moreover, proven Quality management systems (QMT) can also be used by the laboratories of Assisted Reproductive Technology (ART) to meet the requirements of proper control and monitoring of services.
Research/review articles supporting above review
Researchers have noted that “patient-friendly” ART is good only with “high-quality” ART that can be achieved only with patient centeredness and timeliness. In this method of achieving high quality, patients would find it useful as it is more patient-centered, and doctors would also be able to work on the basic aim that is the improvement of quality of ART in proper time. Moreover, researchers would also be able to find procedures on which they may concentrate while investigating quality of IVF2. In another study, researchers have again noted that patient satisfaction along with the proper evaluation of clinical and laboratory protocols are important in IVF setups. They have told that a satisfied patient is that who is aware of the condition or treatment, who knows that best advice has been given along with best possible medical service and supervision. Most of the satisfaction of the customer or patient can be achieved by the proper training and development of educated staff. Researchers are of opinion that adaptation of international standards can help in overall improvement of quality of IVF clinics3. In another study, researchers have noted that suitable quality control (QC) is important for not only accreditation of IVF clinic but also for its success. Moreover, toxicity testing is important for patients and embryos. In this regard, several procedures and assays can be utilized. One of the most important assays, to check the toxicity as well as the sterility of the culture material and/or media, is mouse embryo assay (MEA). This assay can also help in determining those conditions that can result in impaired development. It has been noted in the research that MEA along with other assays for QC can help in improving the conditions of IVF laboratories4.
Review Article # 2
In the article “Total quality improvement in the IVF laboratory: choosing indicators of quality.”5 Mayer et al. have described the concept of the total quality improvement (TQI) within the IVF clinics. They have also provided particular examples of some indicators that can be used in such TQI programs. They have told that TQI is different from QC and quality assurance (QA) in that TQI not only deals with a comprehensive monitoring process for detection and elimination of problems, but it also works on the innovation and development of flexible as well as effective solutions to these problems. Moreover, it is also helpful in improving performance of all phases and aspects of laboratory. Authors have noted that the indicators for good laboratory performance are collection of oocyte as well as sperm, preparation of gamete, identification of sample, fertilization as well as cleavage, cryopreservation, transfer of embryo, laboratory report as well as its safety, and outcomes of the procedures. TQI program deals with all these indicators and help to improve patient care as well as satisfaction. Researchers have also noted that there are three important components of TQI; proper understanding of the situation, thorough analysis of data, and improvement of overall performance.
Research/review articles supporting above review
QC programs are internal to the existence of IVF clinics and QA programs are external to the settings of IVF clinics. Both of these programs are helpful in maintaining a standard for the diagnosis and treatment of human infertility. Researchers have reported that laboratories with well-trained staff, who pay close attention to quality, are important in establishing high pregnancy rates6. In another study, researchers have noted that proper environment for handling of oocytes and spermatozoa are important for normal growth and development of embryo. Proper QC and QA can help in reducing IVF related problems. However, further development is important for optimal and quality oriented clinical services especially in the freezing procedure of oocytes and ovaries, intracytoplasmic transfer, injection of spermatid, and embryo implantation7. In a different paper, researchers have noted that introduction and full implementation of QC system, in which patients’ gametes and embryos are handled properly, is important for IVF clinics. This system could help in bringing improvement in IVF results. Although QC system can help in improving the standard of ART laboratories but it is a kind of nonstop project requiring constant improvement8, and in this case, it can be considered as TQI within in the IVF clinics.
Olofsson JI, Banker MR, Sjoblom LP. Quality management systems for your in vitro fertilization clinic's laboratory: Why bother? Journal of human reproductive sciences. Jan 2013;6(1):3-8.
van Empel IW, Nelen WL, Hermens RP, Kremer JA. Coming soon to your clinic: high-quality ART. Hum Reprod. Jun 2008;23(6):1242-1245.
Alper MM, Brinsden PR, Fischer R, Wikland M. Is your IVF programme good? Human Reproduction. 2002;17(1):8-10.
Gardner DK, Reed L, Linck D, Sheehan C, Lane M. Quality control in human in vitro fertilization. Paper presented at: Seminars in reproductive medicine. 2005.
Mayer JF, Jones EL, Dowling-Lacey D, et al. Total quality improvement in the IVF laboratory: choosing indicators of quality. Reproductive biomedicine online. Dec 2003;7(6):695-699.
Matson PL. Internal quality control and external quality assurance in the IVF laboratory. Human Reproduction. 1998;13(suppl 4):156-165.
Gianaroli L, Plachot M, van Kooij R, et al. ESHRE guidelines for good practice in IVF laboratories. Human Reproduction. 2000;15(10):2241-2246.
Wikland M, Sjoblom C. The application of quality systems in ART programs. Molecular and cellular endocrinology. Aug 15 2000;166(1):3-7.
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