A comparison among 36 assisted reproduction laboratories monitoring the environmental conditions and instrument parameters using the same quality control application

Abstract Research Question Assisted reproduction laboratories record instrument performance periodically. There are no standardized guidelines for this activity in spite of mandatory auditing systems in several countries. This study of 36 laboratories in 12 different countries was conducted to assess differences and similarities between quality assurance programs using an adaptable cloud-based quality control app for instrument monitoring. Design A total of 36 deidentified in vitro fertilization laboratories that subscribed to the same quality assurance app were studied. Data were evaluated based on instrument types allocated to 10 domains: incubators, gas tanks, warming surfaces, refrigerators and freezers, cryo-storage, environment, water purification, peripheral equipment, checklists and miscellaneous. Results The incubator domain constituted the greatest proportion of parameters (35%), followed by surface warming instruments at 15%. Most incubator O 2 readings were monitored between 4.5-5.5%, and between 5.5- 6.5% for CO 2 . The altitude of the laboratory was poorly correlated with the CO 2 setting. Incubator display and measured values of gases and temperature by built-in sensors vary considerably compared with third-party sensors. A quality control diligence score or mean average data points was calculated for each laboratory. This score is independent of number of instruments or laboratory size. Higher scores were associated with laboratories in countries with government regulations and mandatory auditing systems. Conclusions There are major differences in instrument monitoring practices among laboratories. While incubator monitoring is the largest domain, there are many other sensitive instruments that are diligently monitored by most laboratories. There is a need for international standardization and guidelines.