Guidelines for Best Practice for Staffing of ART Laboratories and Professional Development of IVF Scientists

INTRODUCTION

Since the birth of the first IVF baby in 1978, assisted reproductive technology (ART) has rapidly evolved, primarily due to extensive research and medical advancements in the field. With such advancements, the safe and efficient operation of ART laboratories in terms of workload has evolved both in terms of magnitude and complexity, with laboratory activities requiring increased time and resource allocation by scientific staff (Alikani et al., 2014). However, there are currently no standardized guidelines for appropriate scientific staffing levels related to patient volumes and the complexity of treatments offered. In addition, there are no guidelines for professional development for scientists in Australasia. The professional association, Scientists in Reproductive Technologies (SIRT), has a long-standing commitment to increase the profile and professional status of IVF scientists working in the ART industry while promoting high standards within the profession via education and training.

The purpose of this SIRT position paper is to discuss the benefits of ensuring suitable levels of experienced scientific and technical staff in the ART laboratory, as well as the risks that are associated with staffing levels that are below this level. We present an interactive calculator, the Staffing Model for ART (smART) calculator, for determining optimal staffing numbers in an Australian or New Zealand ART laboratory. The development of the smART calculator was based on a previous US calculator shared by Alikani et al. (2014), and specifically designed based on standard Australian and New Zealand national work entitlements. The varying duties of IVF scientists, including contemporary ART procedures and routine laboratory activities performed are also taken into consideration, as well as professional development requirements of all working IVF scientists and technicians. The smART calculator has the potential to be adapted in other countries. Additionally, this paper presents guidelines for scientific training, professional development, and certification of the laboratory workforce, as well as the various roles undertaken in the ART laboratory.

FUNCTION IN THE ART LABORATORY IN RELATION TO STAFFING

Appropriate staffing of an ART laboratory is crucial to its basic function, especially in achieving the “best outcomes” for patients (achieving a pregnancy or live birth). Good clinic management ensures that an appropriate number of trained and competent staff are available to meet the demands and requirements of an ART laboratory. However, when laboratories are not adequately staffed, error rates and risk levels may increase, and subsequently, patient outcomes can be negatively affected.

One of the most significant risks in an ART laboratory is patient and sample identification errors. In Australasia, the Reproductive Technology Accreditation Committee (RTAC) recommends first identifying and then mitigating factors known to increase the chance of misidentification. Factors such as high workload, the number of days worked consecutively by an IVF scientist, staff fatigue, as well as factors that may affect a person’s concentration, have been described as causative factors in increasing the chance of an error occurring (RTAC, 2012). In the UK, the Human Fertilisation and Embryology Authority (HFEA) stipulates in their Code of Practice that staff workload, hours worked, and ensuring that staff take regular breaks are factored into witnessing protocols. Furthermore, the responsibility placed on IVF scientists to constantly ensure errors are not made has anecdotally been linked to increased stress and mental fatigue (HFEA, 2021). This has the potential to increase error and highlights the importance of adequate and appropriate staffing in an ART laboratory.

It has been demonstrated in other science-related industries that inadequate staffing levels can negatively impact patient outcomes and increase stress levels on employees. A survey by the Society of Reproductive Biologists and Technologists (SRBT, USA) in 2018 demonstrated that 89.0% of members experienced work-related stressors in a medium-to-extremely high capacity. Furthermore, 60.6% of members experienced burnout, and 72.8% suffered stress from working overtime (Chang et al., 2019). Similarly, a comprehensive survey conducted by the Association of Reproductive and Clinical Scientists (ARCS) in the UK, reflecting responses from over 60% of IVF scientists from 80 clinics, revealed that 27.8% of members had or were experiencing occupational mental health issues (Priddle et al., 2021). Causative factors included being short-staffed, lack of breaks, working long hours, fear of errors, “blame” culture, and a lack of understanding from management about the work required. WorkSafe Victoria (Australia) states that both physical and mental fatigue and burnout are associated with a decrease in cognitive function and job performance (WorkSafe Victoria, 2022). These are essential components of an IVF scientist’s role and can be directly related to the risk of damage to or loss of gametes and embryos. Furthermore, burnout is a syndrome shown to be related to physical effects such as coronary heart disease and type 2 diabetes, as well as psychological effects such as insomnia, depressive symptoms, and mental disorders (Salvagioni et al., 2017).

Additionally, inadequate staffing levels in an ART laboratory can result in certain tasks becoming compromised. Several procedures performed within the ART laboratory are time sensitive. Without adequate staffing, these tasks will not be completed within ideal time constraints, and result in a decreased chance of a successful cycle outcome (Patrat et al., 2012). The ratio of experienced scientists compared with new scientists must also be considered in ART laboratories. A lack of fully trained and senior staff may result in compromised training of newly employed IVF scientists, due to a lack of comprehensive supervision. This may create increased pressure on new scientists to perform procedures unsupervised, and consequently, due to their limited skills, may result in compromised or adverse outcomes. Other laboratory aspects, such as quality control (QC) and quality assurance (QA) tasks, improvements to procedures, protocols, implementation of new techniques, equipment maintenance, and IVF scientist performance monitoring, may be compromised or unintentionally postponed if staff are unavailable to perform these duties due to inadequate staffing levels. Insufficient staffing may also result in reduced time for continual professional development (CPD) activities, which are important in keeping scientists informed about relevant knowledge and research in the field.

ART LABORATORY STAFFING GUIDELINES AND CALCULATORS

Recently, American Society for Reproductive Medicine (ASRM) and SRBT updated their recommended laboratory staffing levels based on cycle volume, whereby oocyte retrieval cycles and frozen embryo transfers are considered as two different cycles (Practice Committees of the American Society for Reproductive Medicine, ASRM). These guidelines recommend two to three scientists for 1–150 cycles and three to four scientists for laboratories running 151–300 cycles. The paper further recommends one additional embryologist per additional 150 cycles. Of note, these staffing ratios are significantly higher than the 2008 guidelines, supporting that the increased complexity of ART procedures that has developed since that time requires more scientists to perform the same number of cycles. Notably, the updated guidelines reflect that diagnostic andrology and administrative tasks, such as arranging shipments, require laboratory administrative support.

The European Society of Human Reproduction and Embryology (ESHRE) published Guidelines for Good Practice in IVF Laboratories in 2015, in which the staffing recommendation was given as a minimum requirement. For clinics that perform up to 150 cycles, at least two qualified IVF scientists are recommended; in clinics with more than 150 cycles, it was recommended that the complexity of the procedures, techniques, and tasks of each laboratory should be considered, however, no figure was suggested. Again, other duties such as administration, quality management, education, training, and communication were also recommended to be taken into consideration, however, were not described in further detail.

Of note, Alikani et al. (2014) published a comprehensive evaluation of ART laboratory operations in the USA. In this paper, four laboratory directors evaluated and validated the time requirements of all procedures performed by laboratory staff with the aim of devising an “interactive personnel calculator” allowing for optimal and safe staffing levels, which would in turn enhance patient safety and quality care (Alikani et al., 2014). They compartmentalized all the daily processes and procedures, and not only factored in the time taken for each procedure but also introduced a complexity factor to account for the additional time taken for a “complex” process (Table 1).

The other factor included in the calculator was the amount of time taken by staff to perform non-procedural work, which was collectively named as “quality control.” The definition of non-procedural work was broad and did not include tasks such as the management of cryostorage, stock, and inventory. Moreira et al. (2016) estimated that the average time spent on administrative tasks per scientist, per week, was 8.5 hours, which is equivalent to 21% of their working time (Moreira et al., 2016).

While the calculator developed by Alikani et al. (2014) was heralded as the “best model of its day” (Go, 2015), it does have a number of limitations, especially when considered for international use. The calculator does not include diagnostic andrology, intrauterine insemination (IUI) sample processing, or sperm freezing procedures, nor does it include embryo biopsy as delivered in its current form. Many of these procedures are commonly performed in ART laboratories in Australasia. Furthermore, the calculations were based on typical working entitlements for staff in the USA, which only allowed for two weeks of annual leave per year, and no personal leave entitlement. Finally, it did not factor in time spent on continuing professional development (CPD).

The smART calculator

For any calculation model to be successful, it needs to take into consideration the varying duties and roles of scientists, staffing structures, types of ART cycles, and routine laboratory activities performed, as well as national work entitlements. The smART calculator has been modeled after the calculator presented by Alikani et al. (2014), and updates include the types of ART cycles considered, as well as Australasian work entitlements. Differences between the smART calculator’s recommendations and actual staffing numbers should be a suitable prompt for the clinic to perform a risk assessment.

The interactive calculator shared here, which can be downloaded as an excel workbook, is specific to the Australasian region, to suit contemporary laboratory operations and staff working patterns. This can be extrapolated to other regions internationally once formulations are fully understood and modified accordingly. To this end, the detailed calculations associated with the calculators are explained in Appendices 1 to 5. SIRT has modified the two calculators described by Alikani et al. (2014). First, timings associated with laboratory QC tasks should be entered into tab one of the interactive calculators. Next, the cycle numbers of the ART clinic should be entered into the second tab of the calculator. Finally, the days of operation should be entered into tab three of the calculator. It is important to consider both calculations of recommended full-time equivalents (FTEs), and the calculation with the highest staffing levels should be followed. It is most likely that the second calculator will only suggest a higher staffing level where ART laboratories have very low procedure numbers or operate on a “batching” system (e.g., on weeks and off weeks). The smART calculator is not currently linked to a website, but it is intended that a link to the calculator will be available on the SIRT website in the near future.

Determination of personnel hours

For most ART laboratories, a minimum of two personnel may be required on any day when the laboratory is managing cases, and this is particularly pertinent for laboratories using manual double-witnessing systems. When managing cases, a laboratory usually requires personnel to be available seven days per week, however, it is important for wellbeing and risk mitigation that staff should not work above the normal full-time definition, 38 hours worked in a period of days, for example, five days per week. While these five days may cover a weekend, it is important to consider equivalent rostered days off in the week prior to or following the weekend worked. One key calculation is to work out the number of hours a staff member can be allocated to “procedures and QC” in 1 year, which we refer to as hours per full-time equivalent (h/FTE).

In Australia and New Zealand, in a calendar year, an employee is typically entitled to 4 weeks annual leave, and personal (sick/carer’s) leave is taken only when required. Two weeks of personal leave per annum is deemed to be a realistic average by SIRT. Thus, full-time personnel should be available for work for 46 weeks in the 52-week year. With 37.5 hours (h) worked being the typical expected working week in Australia and New Zealand, it is estimated that each personnel should be available for duty for 1,725 hours in 1 year [($37.5\times 46$) (see Appendix 1)].

Go et al. (2015) expressed the importance of professional development with Reinzi et al. (2021) reinforcing this; “the clinical embryologist should have (or develop during his/her career) a strong scientific background enabling the embryologist to make decisions that best serve their patients.” The smART calculator differs from that developed by Alikani et al., as it also factors in professional development, using the formula that 4% of a scientist’s time should be spent on professional development. This equates to approximately 1.5 hours per week or 69 hours per year. Thus, the final number of hours available for procedures and QC is 1,656 hours/year, which is notably almost 12% less than the Alikani et al. calculator (1,875 hours/year). Of note, like Alikani et al.’s calculator, the smART calculator does not take into account the seniority of the IVF scientist, merely whether they are capable of performing laboratory tasks, meaning that some laboratories may require differing levels of staff due to the experience and efficiency of individuals within the team.

Determining the number of hours required for quality control

In the first tab of the interactive calculator, the “QC” section of the smART calculator considers daily, weekly, monthly, and yearly processes and managerial tasks (Appendix 2). This calculation will differ depending on the size of the laboratory, and hence the “hours spent per task” was based on a medium size laboratory doing approximately 2,000 cases. It was calculated that this size laboratory would require 1.5 FTE scientists to perform QC work alone each year (Fig. 2).

Main calculator

In the second tab, the main smART calculator is based on a total of 12 procedures routine to the ART laboratory: IVF, ICSI, ICSI $+$ Biopsy, ICSI $+$ TESE, FET, FET from PGT, oocyte vitrification, oocyte warming, IUI, sperm freeze, TESE $+$ sperm freeze and semen analysis (see Appendix 3). These procedures are not an exhaustive list, however, they are more relevant to today’s ART laboratory than the five procedures discussed in Alikani et al. (2014). Each procedure was calculated step-by-step, and average times are detailed in Appendices 1 to 5.

To give an example using the smART calculator, the IVF/ICSI procedure time calculation was based on an average of 10 oocytes per case, with embryo transfer and blastocyst vitrification performed on Day 5 (Fig. 1). A precise time for all procedures was allocated, then a complexity factor (doubling the time allocated) was incorporated when a procedure involved one or more of the five elements described above in the complexity list (Table 1). The components considered “complex” typically require witnessing, which requires more personnel time, thus can be incorporated as a sixth element.

In addition to the preparation of paperwork and data entry for patients, administrative tasks include the following: management and import/export of gametes and embryos in storage, accreditation (e.g., RTAC), management of stock inventories, handling patient enquiries, and providing updates to doctors and patients.

It should be noted that if an individual clinic has a large discrepancy (higher or lower) of calculated FTEs compared with that recommended by the smART calculator, the clinic should consider factors that are potentially influencing the laboratory operational needs and therefore their required staffing numbers.

Potential factors to consider may include, but are not limited to:

While the smART calculator is predominantly designed to ensure adequate staffing levels, the calculator also offers individual clinics a means of calculation to ensure overstaffing is not occurring. This will assist in allowing the clinic to operate in a more cost-effective manner while offering high-quality patient care without the risks associated with inadequate staffing.

EDUCATION, ROLES, EXPERIENCE, AND COMPETENCY OF IVF SCIENTISTS

While the smART calculator provides a comprehensive tool to recommend an appropriate number of personnel, the staffing structure, including education, experience, and competency levels (i.e., trained vs. trainee ratio) needs to be carefully considered by each individual ART clinic to ensure that best practice and outcomes are achieved. ALPHA, an international forum for scientists in reproductive medicine, published their outcomes from an international workshop on defining the professional status of IVF scientists in 2015 (Alpha Scientists in Reproductive Medicine, 2015). One consensus point was that a Bachelor of Science degree is recommended as a minimum qualification for nonsupervisory roles. For managerial positions, such as laboratory supervisor and scientific director, a minimum of a Master of Science (MSc) is recommended. Similarly, in Australasia, the RTAC Code of Practice (2021) now includes the requirement of a Doctorate or MSc in a relevant field for a Scientific Director role, as well as a MSc or Postgraduate Diploma for laboratory supervisory or managerial positions. However, it does not provide any minimum education requirements for other IVF scientists in the clinic.

The types of positions and roles within an ART laboratory depend on the number of IVF cycles conducted, as well as the complexity of laboratory techniques that are offered by the ART clinic. Generally, these positions are categorized into staff experience levels or grades that relate to full-time years of experience. It is important to note that determining competency is different to experience, and both should not be seen as being hand-in-hand. Typically, a scientist is trained in procedures, and then competency is further assessed on a regular basis. Competency may be reviewed at different time-periods in laboratories, and at a minimum, this should be performed annually. There is always a potential that an experienced staff member may not be currently technically competent in a laboratory task.

SIRT considers it essential that each ART laboratory should have clearly defined roles and categories of scientists within the laboratory and requirements for progression. At a minimum, SIRT recommends instilling a policy that covers training and competency so that scientists know what is expected of them and how they can progress in the field. When staffing an ART laboratory, it is important to consider the roles of laboratory support staff, laboratory technicians, trainees, experienced IVF scientists, and the number of laboratory seniors and supervisors (including scientific directors) into the full laboratory FTE total number, as every scientist contributes to the functioning of the team. The clinic should be responsible for ensuring an adequate number of experienced scientists for optimal patient care.

The following is recommended by SIRT as the best practice for education, guidelines, and experience for various roles of laboratory staff, taking into consideration documentation by RTAC and other organizations. It should be noted, however, that the relevant RTAC Code of Practice may suggest a laboratory experience level that is significantly below what SIRT is recommending in this paper.

Laboratory support staff and laboratory technicians

The recommended education requirements for Laboratory Support staff or Laboratory Technician are dependent on the roles your laboratory assigns to these staff.

This could be less complex, administrative roles (e.g., data entry, specimen reception, telephone tasks), through to more technical laboratory technician tasks (e.g., laboratory QC, laboratory media, or andrology training etc.), which will have a higher education requirement. SIRT supports the recommendation by the Australian Council for the Certification of the Medical Laboratory Scientific Workforce (CMLS) that the minimum education requirement for a Laboratory Technician be the completion of a relevant VET sector course at Australian Qualifications Framework (AQF) Level 5 or 6 (CMLS, 2022).

SIRT strongly recommends if the role involves handling human gametes or embryos in culture that the individual should have a tertiary or postgraduate qualification from an approved institution.

The training time for Laboratory Support or Laboratory Technician roles can be variable, but it would be expected in a matter of months any Support or Technical staff would have completed their initial training and would be working in the team, unassisted in their allotted tasks.

Trainee IVF scientist

A trainee IVF scientist is recommended to have a tertiary or postgraduate qualification from an approved institution, demonstrating a broadly based scientific experience in reproductive biology, with expertise and/or specialized training in the physiology of reproduction, cell biology, and biochemistry.

During the training period, a trainee IVF scientist will undergo training under supervision until deemed competent and confident in laboratory procedures. It is the responsibility of the laboratory manager/supervisor and/or scientific director to provide an adequate and consistent training program that clearly outlines the goals and objectives of the training process and sets reasonable timeframes to achieve these goals.

Responsibilities in the laboratory increase with skill and exposure to tasks, and the level of supervision will decrease as capability improves. To continue career progression and encourage continued education, SIRT strongly advises against limiting staff training to only specific procedures (unless the trainee has been employed to fill a specific role that is clearly defined in their individual contract).

The training time for an IVF Scientist can be variable depending on the cycle numbers of the clinic, however, it is expected that training of all routine laboratory procedures will take at least 12 to 24 months. Routine laboratory procedures may include all procedures mentioned in Fig. 2, with the exception of embryo biopsy (which is viewed as an advanced procedure that not all clinics may perform). After this time, trainees are expected to have completed their training and to be working as a full member of the team, unsupervised in their allotted tasks.

Trained IVF scientist

A trained IVF Scientist (either trained within the clinic or employed externally), should be able to complete all specified procedures unsupervised (as outlined in Fig. 2, with the exception of embryo biopsy). This is in line with recommendations from CMLS as well as the Australian Institute of Medical and Clinical Scientists (AIMS) immigration assessment requirements for IVF scientists (AIMS, 2022; CMLS, 2022).

A trained IVF scientist should also be expected to be assessed for technical competence at defined times by supervisory staff and should expect some degree of feedback or retraining if technical competence does not meet expected key performance indicators (KPI). It is important for accredited clinics to recognize the training of scientists performed by other RTAC clinics, and not treat newly employed trained IVF scientists as “trainees” if they transfer to a new ART clinic. It is expected that the new clinic will have a conversion training program that needs to be completed and signed, ensuring that any technical differences (or new equipment used) are covered.

Acquiring additional skills and training, as defined by laboratory requirements, is expected from a trained IVF scientist. This relates directly to ongoing education, skill, and professional growth and development. They may also take on alternative responsibilities within the laboratory. Being trained is the start of the rapid growth phase in the career and professional development of an IVF Scientist.

Senior IVF scientist

Recommended minimum 5 years of embryology experience after completing training.

Senior IVF scientists should be competent in all areas of laboratory processes and procedures, and hold, or have held accessory roles in the laboratory such as, but not limited to, transport management, asset and/or equipment management, donor sperm coordination, quality management, and data management.

The individuals who occupy these roles should be able to troubleshoot effectively within the laboratory, as directed by the laboratory manager/supervisor and/or scientific director. These individuals can be relied upon to manage the workload and clinical queries that arise, should the laboratory manager be absent. These scientists will be heavily involved in the training of new IVF scientists and contribute to QC and QA.

It is understood that nationally (and internationally), the term “Senior Scientist” may be assigned differently at some clinics. Some clinics set a ratio of senior scientists to OPU’s, while others assign the title when staff is deemed to meet the internal criteria for becoming a senior scientist. This is something that should be clarified inside the ART laboratory documentation and/or Enterprise Agreements.

Laboratory manager/supervisor

Recommended minimum 5 years embryology experience after completing training, and to have at a minimum a Master’s degree or postgraduate diploma from an accredited institution.

The RTAC Code of Practice (2021), has defined that in a laboratory where the scientific director is offsite, a laboratory manager/supervisor must be appointed to perform the daily management of the laboratory. Many laboratories will have laboratory manager/supervisors in addition to an onsite scientific director.

Laboratory managers/supervisors should be competent in all aspects of clinical embryology, demonstrate continued ongoing education and possess the knowledge required to oversee the operations of an IVF laboratory in accordance with RTAC regulation. They are also responsible for the training and competency of all scientific staff working in that laboratory. It should be noted that years of embryology experience may not guarantee the essential skills required for successful management. Skills such as, but not limited to, good communication, organization, interpersonal skills should be considered alongside years of experience, especially in geographically remote clinics where staff availability is scarce.

Scientific director

Ideally, 10 years of embryology experience after completing training, with $>2$ years of experience in a managerial and/or supervisory role, and must possess a Master’s degree from an approved institution, or a Doctorate (PhD) from an accredited institution in reproductive biology or at a minimum an MSc.

The Scientific Director is responsible for the scientific management within the ART laboratory and the training, competency, and supervision of all scientific staff involved in the organization. The individual must have experience in the management of an ART laboratory as appropriate to the services offered and must possess demonstrable knowledge of and continuing education in all laboratory aspects of the organization. As above, years of embryology experience may not guarantee the essential skills required for successful management, and it is important to assess both the importance of technical knowledge and managerial skills to run a successful ART laboratory.

Although not compulsory, it is currently recommended (and specifically for Australia): Scientific Directors should also be certified with CMLS as Clinical Scientist, recognizing that they meet the required National Pathology Accreditation Advisory Council (NPAAC) standards, including the supervision requirements for medical laboratories. This is especially important for the supervision of laboratories that are required to be accredited with the National Association of Testing Authorities (NATA), for example, for performing semen analysis or other diagnostic testing.

While this document recommends that all IVF scientists have a science degree and that Supervisor and Director positions have a postgraduate qualification, it is recognized and accepted that there are currently experienced IVF scientists who do not hold these recommended qualifications and are already trained and competent inside their laboratory framework. RTAC has devised a “grandfather” time of 1/10/2017 (which indeed was when the 2015 RTAC Code of Practice was in force), therefore supervisory laboratory staff who were appointed before 1 October 2017 and fulfilling the RTAC Code of Practice requirements existing at that time will be exempt.

Competency framework

A competency framework is a structure that clearly defines the ongoing competencies required by employees and is critical in assisting employees understand what is expected of them in a particular role.

The steps in developing a competency framework are as follows:

In summary, recognition as a “professional” requires some form of external evaluation for certification of competency. Since evaluation of practical skills must be done within the environment in which the work is normally performed, a logbook is the most accepted tool for demonstrating practical experience. A competency-based logbook, developed within a competency framework, records outcomes as well as experience, and so is a good tool for assessment. Further details can be found detailed by CMLS (CMLS, 2022).

Once deemed competent in a process, the ongoing competence of each IVF scientist should be reviewed at regular intervals. The number of procedures performed should be reviewed as well as clinical outcomes of key procedures performed. SIRT recommends that each ART laboratory should define acceptable limits for both competencies and the number of procedures performed, and how often competency checks are required. There have been several papers published discussing KPIs, which can be referred to (De los Santos et al., 2016; ESHRE and ALPHA, 2017).

Working conditions within the ART laboratory

Within Australia, all IVF scientists are broadly covered by the “National Employment Standard” (NES) and further covered under the Health Professionals and Support Service Award 2020. New Zealand-based IVF scientists are covered by Employment New Zealand’s Document, “Minimum employment rights and responsibilities,” covering similar employment standards as the NES. However, these detail only minimal regulations and entitlements and are not directly relevant to the ART industry.

In both Australia and New Zealand, some ART laboratories additionally have in place legally binding registered agreements, Enterprise Bargaining Agreements (EBA) and/or Collective Enterprise Agreements (CEA) (respectively) that further specify wages and working conditions as set out in the NES and that have been negotiated by the employer and employees. However, not all ART laboratories are bound by EBAs/CEAs and even in units with such agreements, the country’s national work provisions are still the overarching standards that cover Australian and New Zealand scientists and cannot be excluded from such agreements. For example, the NES does not define the “appropriate” hours of overtime with relation to increasing fatigue and risks in the laboratory.

SIRT recommends laboratories proactively engage with their clinic management structure/employer and agree on staff safety criteria and the appropriate staffing levels using the smART calculator that will apply to the laboratory. This review should avoid discussion of salaries or financial conditions, and rather focus on identifying with their employer, the staffing levels and safe working conditions for IVF laboratory staff to ensure patient gametes and embryos are not compromised. This may cover such initial topics as:

These factors are critically linked to risk mitigation within the laboratory. Therefore, SIRT views that it is the clinic’s responsibility to ensure adequate staffing, to minimize overtime and to reduce associated fatigue. Given that IVF scientists hold the responsibility required for safe handling of gametes and embryos, it is critical that ART laboratories clearly define appropriate working conditions to ensure that risks are mitigated, and patient outcomes are prioritized. Note that clinics must show a commitment, as detailed in the RTAC COP, to ensure adequate staffing, training, and ongoing education.

CONTINUING PROFESSIONAL DEVELOPMENT AND CERTIFICATION

To ensure the continued and ongoing high standards of science in ART in Australia and New Zealand, it is important to address not only the qualifications of new individuals entering the field, and the staffing levels required for adequate operation of an ART clinic, but also to encourage and support those already working in the industry to continuously participate in ongoing education.

As such, SIRT proposes and describes several recommendations regarding CPD and Certification.

Continuing professional development

A key requirement for RTAC certification and recertification is participation in and recording of CPD. CPD are the activities undertaken in addition to on-the-job training and learning that contribute substantially to the improvement of skills and professional development as laboratory staff. CPD is the responsibility of the individual and includes activities such as reading journals/papers, viewing webinars, attending journal clubs, local and national/international conferences, undertaking research projects, and authoring scientific publications. The requirement for CPD can be met by any scientist and does not place an unreasonable burden on employers. Supporting scientists to undertake CPD and become certified demonstrates an organization’s support for professional standards and lifelong learning. CPD also provides patients with a level of confidence in a clinic’s laboratory and highlights that scientists strive for good laboratory practice and are continually working at a high standard. CPD also allows for:

In Australia, no legislative or industry requirements currently exist requiring IVF scientists to use a recognized CPD scheme. However, it is acknowledged that an appropriate system facilitates employers and accreditation bodies (such as RTAC) in monitoring the competency and professional development of IVF scientists. Whilst CPD programs are not mandatory in Australia, it is important to understand the considerable advantages to individual scientists, clinics, the ART profession, and ultimately the patients who are cared for.

Some examples include:

The SIRT committee recommends that an appropriate, well-structured, and clearly defined CPD program be recognized and adhered to by all ART units in Australasia. The recommended CPD schemes for Australia and New Zealand are listed below.

Australasian Professional Acknowledgement of Continuing Education (APACE)

An extensive voluntary CPD program—APACE has been developed by the Australian Institute of Medical Scientists (AIMS), which recognizes continuing education, formal courses, and other professional activities that contribute and expand on professional growth. It is accepted by CMLS and is recommended by SIRT for Australian and New Zealand IVF scientists.

New Zealand Institute of Medical Laboratory Science (NZIMLS)

The NZIMLS represents individuals in the professions of Medical Laboratory Science in New Zealand. It promotes professional development through education, communication, and a code of ethics to achieve best laboratory practice and service for the general public of New Zealand. A structured and detailed NZIMLS CPD scheme is clearly defined and recognized by all New Zealand ART laboratories.

Certification schemes

In New Zealand, the Health Practitioners Competency Bill (2003) states that all health practitioners must demonstrate competence in order to receive an Annual Practicing Certificate; this requirement must be met by being registered by the Medical Sciences Council of New Zealand.

The medical laboratory science profession in Australia now has its own national professional certification scheme. In the absence of a regulatory requirement for registration, as operates in most OECD countries, a self-managed certification scheme, CMLS, was designed in recognition of the vital role scientific and technical staff play in the safe operation of Australian medical laboratories.

The Medical Laboratory Scientific Workforce (CMLS) Certification scheme is an independent, national scheme aimed at ensuring members are qualified, competent, and certified. It is the recommended certification scheme of the Fertility Society of Australia and New Zealand and SIRT.

The latest RTAC Code of Practice (2021) recommends that Scientific Directors and Laboratory managers/supervisors obtain Medical Laboratory Scientific Workforce (CMLS) Certification. SIRT strongly encourages all scientists working in ART in Australia and New Zealand to become professionally certified.

CONCLUSION

As IVF processes continue to evolve and change, it is paramount that clinics have the appropriate staffing numbers to support the operation of their laboratories. The smART calculator can assist clinics to determine if their staffing levels are appropriate for the level and complexity of clinical work that they undertake. The smART calculator has been designed specifically for Australasian ART laboratories and is designed to eliminate some of the variables that exist in the operations of IVF laboratories. However, the calculator cannot fully account for staff experience and capability, as well as the various roles within an ART laboratory.

When reviewing the staffing numbers supplied by the smART calculator, if a clinic varies significantly from the recommended FTE, the organization should undertake a review of their laboratory to determine why a variance has occurred, in order to mitigate risk and provide optimal care for patients, as well as ensure staff well-being and continued career progression. Alternatively, the smART calculator may also be used to ensure that overstaffing is not occurring, and allow the clinic to operate in a cost-effective manner while offering high quality patient care without the risks associated with inadequate staffing.

Ongoing education is not just important for an organization to meet certification standards, but for IVF scientists, it is key to the progression of this profession to ensure individuals are continually kept abreast of new scientific developments. There are external education schemes in which scientists can register to ensure there is continued ongoing professional development. Clinics should also consider their own internal QA program and competency framework.

Ultimately, this SIRT position paper has highlighted the benefits and risks in the IVF laboratory associated with staffing levels, discussed the required positions of laboratory staff and the benefit of ongoing professional development. This has been done to establish firm, thoroughly researched recommendations for optimal scientific staffing levels to be implemented in Australasian IVF clinics. SIRT believes the smART calculator will be an invaluable tool moving forward for all ART laboratories.

Declarations of interests: None.

ORCID

Yee Shan Lisa Lee  https://orcid.org/0000-0002-0778-9636

SUPPLEMENTAL MATERIALS

The Supplemental Materials, including the smART calculator, are available at: https://www.worldscientific.com/doi/suppl/10.1142/S2661318223500160.