Recalculating the Staff Required to Run a Modern Assisted Reproductive Technology Laboratory

E. Veiga; C. Olmedo; L. Sánchez; M. Fernández; A. Mauri; E. Ferrer; N. Ortiz

Disclosures

Hum Reprod. 2022;37(8):1774-1785. 

In This Article

Abstract and Introduction

Abstract

Study Question: What number of staff is sufficient to perform increasingly complicated processes in today's modern ART laboratories?

Summary Answer: The adequate number of personnel required for the efficient and safe operation of modern ART laboratories needs to be calculated.

What is Known Already: In today's modern ART laboratories, the amount of time required to perform increasingly complicated processes has more than doubled, with a downward trend in the amount of work an embryologist can do. Different workload unit values have been used to evaluate each workload task and efficiency in a particular ART laboratory, as well as to occasionally compare one laboratory with another.

Study Design, Size, Duration: Seven senior embryologists working at different IVF centers, three public and four private centers, participated in this multicenter study conducted between 2019 and 2020. We prepared a survey to create a calculator for staff using the average (of three attempts) time spent in every laboratory by each embryologist of the center to perform any ART process.

Participants/Materials, Setting, Methods: Different laboratory processes and activities related to quality control, time spent and conventional human double witnessing were included in the survey. To calculate the number of processes that each embryologist can perform per year, an embryologist was considered to be having a full-time contract and working 7 or 8 h/day. The times included in the calculation of each task were those corresponding to the 95th percentile. For the calculations, Microsoft® Office Excel® Professional Plus 2019 was used.

Main Results and the Role of Chance: The survey showed that the time needed per embryologist to perform the different processes necessary for a classic IVF cycle without time lapse (TL) was 8.11 h, and with TL, it was 10.27 h. The calculated time also considered the time spent in documentation handling, cycle preparation, database management and conventional human double witnessing verification. An ICSI without TL needed 8.55 h, and with TL, it needed 10.71 h. An ICSI-PGT without a TL cycle needed 11.75 h, and with TL, it needed 13.91 h. Furthermore, 1.81 h should be added for every vitrification support needed. The time needed to control more than 200 critical steps, including equipment control and culture parameters, was 30 min per day plus 3.9 min per device to control.

The time spent in semen analysis (including documentation handling, cycle preparation and database management) or intrauterine insemination with a partner sperm was 2.7 h. For donor sperm, an additional hour was required for the management involved. The time required to perform a testicular biopsy and cryopreserve the sample was 4 h. Similarly, the time required to perform seminal cryopreservation was 3.7 h.

Limitations, Reasons for Caution: The study was conducted considering a full-time contract embryologist working 7 or 8 h/day, 5 days a week, with days off according to the Spanish regulations. However, our findings can be adapted to foreign regulations using the developed online calculation platform.

Wider Implications of the Findings: A new advanced staff calculator allows any IVF laboratory to estimate the minimum number of embryologists necessary without compromising the security or success of the results. Nevertheless, we recommend a minimum of two qualified embryologists in every laboratory, regardless of the workload.

Study Funding/Competing Interest(S): This work was funded by the Asociación para el Estudio de la Biología de la Reproducción (ASEBIR). None of the authors has any conflict of interest to declare.

Trial Registration Number: N/A.

Introduction

An axiom in virtually any human industry is that the staff that conduct the mission of the company are its greatest resource, as they provide the expertise and creativity vital to the product or service. Therefore, a team of clinical embryologists, which develops and performs a long list of different processes and activities, is the most valuable and critical resource of an ART laboratory (Go, 2015; Wiemer, 2017). The number of embryologists necessary for the safe and efficient operation of an ART laboratory depends on the volume and types of processes performed (Boone and Higdon, 2005).

The increased complexity and time requirements of the latest reproductive technologies, such as ICSI, preimplantation genetic testing (PGT), oocyte vitrification and artificial intelligence, have resulted in a significant increase in the amount of time required to perform a treatment cycle. Furthermore, the demands of the laboratory have multiplied in terms of equipment maintenance, record keeping, training and compliance with regulations; therefore, the number of employees required for the efficient and safe operation of the laboratory must be adjusted to comply with these demands. Thus, in modern ART laboratories, the amount of staff time required to perform increasingly complicated processes has more than doubled (Alikani et al., 2014; Wiemer, 2017).

To date, there is limited research that deals with this topic in a comprehensive manner, despite its importance. A bibliographic search on human resources in ART laboratories reveals no mention of the number of embryologists recommended per process performed in the laboratories in many of the publications. Most publications only recommend that the staff is appropriate for the workload. According to the 2008 guidelines published by the ASRM and its subsequent revisions, the Fertility Society of Australia and New Zealand, ACE, as well as the ESHRE for the staffing of ART laboratories, there must be a minimum of two qualified persons available to perform all processes (The American Fertility Society, 1992; Association of Clinical Embryologists, 2000; Practice Committee of American Society for Reproductive Medicine and Practice Committee of Society for Assisted Reproductive Technology, 2008; Asociación Española de Normalización y Certificación (AENOR), 2013; Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology, and Practice Committee of the Society of Reproductive Biologists and Technologists, 2014a,b, 2020; ESHRE Guideline Group on Good Practice in IVF Labs et al., 2016; Núñez et al., 2016; Fertility Society of Australia and New Zealand, 2020; Ferrer et al., 2021; Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology, and Practice Committee of the Society of Reproductive Biologists and Technologists, 2021). These guidelines unanimously establish that there should be an embryologist for every 150 IVF cycles performed per year and recommend a minimum of two embryologists. However, this number has decreased over time, with the latest publications, specifically the study by Alikani et al. (2014), establishing a maximum of 100 cycles per embryologist. There is a downward trend in the work that an embryologist can undertake.

Additionally, for trained employees to be competent enough to do their job, continuing educational opportunities must be provided. This includes introducing employees to new techniques, updating them on existing methods, and allowing them to update their knowledge and skills (European Parliament and of the Council, 2004; Hughes and Association of Clinical Embryologists, 2012; International Organization for Standardization, 2012; Hardarson, 2014; Alpha Scientists in Reproductive Medicine, 2015; Choucair et al., 2021). The monitoring and evaluation of the number of treatments performed and the actual workload of a laboratory have been factors used by laboratory directors and administrators to study the efficiency of a laboratory (McAllister and Leveille, 2007; International Organization for Standardization, 2012; Asociación Española de Normalización y Certificación (AENOR), 2013).

To evaluate the workload by processes, it is necessary to calculate the hours required to perform each process and know the available work time, which is the sum of hours worked by each embryologist per year. The number obtained will determine the staff needed to conduct all the processes. Different workload units have been used to evaluate each process as well as the efficiency of an ART laboratory to enable the comparison of one laboratory with another. However, imprecise evaluations and sometimes incorrect comparisons have been made because of incorrect or outdated estimates, omission of certain laboratory activities or different calculations performed at different institutions. Therefore, this study aimed to calculate the time required to develop the processes performed in a modern ART laboratory. By so doing, the needs of trained and competent staff to conduct all the necessary activities can be calculated.

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