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1 Introduction to Competency Assessment

One of the most important components of quality management in an andrology laboratory is competent performance of the complex tasks leading to accurate results. This relies on having competent personnel, starting with the laboratory director and including all supervisory and testing personnel involved in testing, processing sperm, and quality control procedures. There are a number of recent chapters and reviews that cover this subject [1–3] as well as guidelines from societies, including the European Society of Human Reproduction and Embryology (ESHRE) [4] and the American Society of Reproductive Medicine (ASRM) [5, 6], and guidelines from organizations, including the World Health Organization (WHO) [7] and International Organization for Standardization (ISO) [8]. Governmental and accreditation agencies often include personnel requirements for clinical laboratories. This chapter will focus on assessment of personnel performing testing in the andrology laboratory with examples from the author’s facility.

Andrology testing is high complexity and requires highly qualified personnel. In most cases, a 2- or 4-year college/university degree in a laboratory science or the equivalent is required. Significant training and evaluation of personnel is also necessary, and, in the USA, a year of conducting clinical testing under direct supervision is required before testing personnel can work independently in a clinical laboratory [9]. The personnel file of each laboratory staff member should contain:

  • Documentation of qualifications

  • References

  • Health records (e.g., vaccinations)

  • Training

  • Performance evaluations

  • Continuing education

If the laboratory is part of a hospital or clinic, some of the personnel policies will be provided by the institution, which may have a human resources (HR) department; nevertheless, the laboratory requires its own personnel policies that may refer to those of the managing organization when applicable. Independent andrology laboratories must have complete, written personnel policies, without the benefit of an organizational framework. A clear description of each employee’s responsibilities is key to laboratory quality. Job satisfaction and employee retention require that each staff member understands what is required of them and what is provided for them by the employer.

2 Attributes of Laboratory Testing Personnel

The laboratory requires enough personnel, having the necessary education, training, and experience, to conduct all of the management, supervision, and testing being performed. Due to the increase in quality management procedures and the increasing complexity of testing methodology, the time required to perform and IVF cycle has more than doubled [10] in recent years, and, for similar reasons, andrology testing has also become more labor intensive. In general, the laboratory requires a director, supervisor(s), and testing personnel. This could be a single individual for a small laboratory, provided there is a backup person available with the required training, qualifications, and accreditation (if applicable) to conduct andrology testing without direct supervision. An individual may act as the laboratory director for multiple laboratories, but a qualified supervisor must be on-site during all hours of testing and should review all results within a day of testing.

The laboratory standard operating procedures (SOPs) should include descriptions of the personnel needs, titles, responsibilities, and duties of testing personnel. In many countries and regions, the qualifications and responsibilities of clinical laboratory personnel are included in governmental regulations, standards of accreditation organizations, and guidelines of scientific societies. In the latter case, the practice committees of scientific societies may have more stringent requirements than those of governmental regulations and provide guidance on the standard of care for clinical practice.

The requirements for clinical testing personnel have evolved over time and now require persons capable of analytical thinking [11]. Although there are SOPs that define the steps required for testing and a supervisor available to answer questions that arise, modern clinical testing involves the ability to understand the SOP, recognize unusual circumstances, determine when assistance is required, and document any deviations from the SOP during testing.

In addition to the technical and cognitive abilities of laboratory staff, it is important that there is a culture of teamwork, integrity, confidence, and motivation in the laboratory [12]. Accurate results require personnel who take ownership of their position and have confidence in their work arising from universal participation in quality management. Good teamwork requires trust, respect, and cooperation among coworkers [1]. One person with undesirable character can easily poison the working environment in the laboratory, inevitably resulting in poorer quality of the laboratory’s results. These “soft” aspects of an applicant’s character can be challenging to assess during the hiring process, and it may be advisable to consult with an HR professional if the laboratory lacks access to an HR department.

3 Training Laboratory Testing Personnel

The laboratory director is responsible for defining the training needs for testing personnel. This includes initial training, on-the-job training and continuing education. Even if the new technician has worked in another andrology laboratory, it is important that new personnel are trained in all SOPs. In fact, retraining of experienced andrologists can be challenging in that changes in cherished methodology used in the past may be necessary. Training will be most effective if the trainee understands the reason why a specific procedure is important. Take the time to explain the principles and encourage questions from the trainee. Notes can be added to the SOP to address some of these questions, providing early reinforcement of the trainee’s importance to the team.

3.1 Initial Training

Initial training will generally include considerable instruction in background information before the trainee works in the laboratory. Although the institution may provide some of this training, there should be SOPs in place to cover initial training in policies specific to the individual andrology laboratory. Regardless of the prior experience of a new staff member, the basics should be covered to insure his or her understanding and commitment to quality performance in the new position. This includes:

  • Code of conduct

  • Personnel policies

  • Chain of command

  • Culture of quality

  • Laboratory safety

  • National, state, local, institutional regulations

  • Materials and reagents

  • Use of SOPs

  • Daily QC

After this background training, the new staff member can work side-by-side with a supervisor to begin learning the basics of facilities management, equipment operation, and laboratory supplies. This will involve many of the regular QC activities described in the preceding chapter. It is advisable that the trainee have a firm grasp of these aspects of laboratory quality before proceeding to actual testing.

Finally, the new employee learns specimen receipt and testing procedures, by:

  1. 1.

    Observation of testing personnel

  2. 2.

    For semen analysis: side-by-side analysis of semen with approved testing personnel

  3. 3.

    For sperm processing: practice with donor specimens or semen remaining after completion of semen analysis

Ideally, the laboratory has benchmarks that indicate when a trainee can be considered for patient testing; examples are given by Björndahl et al. [2], including recovery of motile sperm after sperm preparation or cryopreservation. These authors also suggest that these benchmarks be achieved on three consecutive events followed by a determined number of successful procedures under close supervision.

During training, a supervisor coaches the trainee and (1) provides critical assessment of the trainee’s work, (2) provides positive feedback for desirable performance, and (3) acts as a role model for teamwork, integrity, confidence, and motivation. During this stage of training, the employee will learn the importance of faithful adherence to the SOPs and accurate documentation of all activities, including deviations from the SOPs. It is particularly important that transparency is emphasized, reporting of errors is encouraged, and the trainee knows the steps to take if an error occurs.

As the staff member learns the testing procedures, the foundation material can be reinforced and put into context. For example, a technician approved to receive and accession specimens into the laboratory should also know the regulatory requirements for that activity. Encourage questions and instill quality performance among technologists and leading by example. The supervisor should always be available and willing to answer questions, for example, looking at an unusual specimen when the testing person is unsure of how to measure or record results.

When the testing person is judged competent to perform a task, documentation is required to authorize him or her for clinical testing. Table 3.1 shows an example of a form used by the author to document training. In the early stages of a new andrologist’s testing, it is advisable to perform more frequent evaluation of inter-technician QC until stable QC results are routinely obtained. Note that training records should be maintained after termination of an employee for a time determined by the laboratory and applicable regulations.

Table 3.1 Sample training form documentation for andrology laboratory personnel
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3.2 Ongoing Training and New SOPs

Training is an ongoing process occurring for all employees over time. Informal training will occur whenever the technician is working in the lab under supervision, but formal training must also be documented. Whenever an SOP changes within the scope of an employee’s work duties, the technician must (1) be trained in the changes, (2) read the new SOP, and (3) document that they have reviewed the new SOP. In addition, each employee should regularly review (e.g., annually) all SOPs relevant to the testing he or she is approved to perform, including the associated policies and procedures for personnel, facilities, equipment, QC, quality assurance (QA), and laboratory safety. Annual refresher training should also be offered, covering code of conduct, safety, and laboratory compliance with regulations (government and institutional if applicable).

3.3 Continuing Education

An important part of a technician’s training is continuing education. Medical knowledge is increasing and clinical testing is no small part of the resulting changes in patient care. Technicians should be exposed to new techniques and better understanding of the principles underlying current methodology. Regulations and safety methods also change over time. Ongoing improvement of the technician’s knowledge base will help maintain excellence of the andrology laboratory. There are multiple formats for continuing education.

  • Scientific conferences, local meetings, and/or workshops—a highly effective method because technicians benefit from formal lectures as well as direct communication with their peers.

  • Online courses and webinars offered through scientific societies and accreditation agencies—in some cases, these are free or low cost to members.

  • Lectures from the clinicians who are clients of the laboratory service.

  • Reading material provided by the laboratory director in the form of manuals, book chapters, and scientific papers—subsequent evaluation of the technician’s comprehension is advised.

  • Directed literature review—technicians can assist the laboratory by researching methodology.

One method of training documentation is having the technician write a summary of what they learned.

In the process of continuing education, personnel are exposed to information from outside the laboratory in which they work. This can lead to stimulating discussions among laboratory workers. Ideas for improvements proposed by personnel should be entertained if possible, ideally allowing the technician to conduct small studies or literature reviews to compare proposed innovations with the laboratory’s current methodology.

4 Process of Personnel Assessment

Once an employee is approved to perform testing, his or her performance must be monitored and this evaluation documented.

4.1 Routine Monitoring

Routine evaluation of personnel by the supervisor includes:

  • Observing routine patient testing

  • Observing instrument maintenance and function checks

  • Monitoring the recording and reporting of results

  • Reviewing test results and test QC

Providing the staff member with regular, constructive feedback during the performance of laboratory tasks and acknowledging improvement can give the employee confidence in his or her personal performance and pride in the quality of the laboratory’s results. A proven teaching method is asking the learner questions, including what the technician would do in hypothetical situations, what regulations govern his or her current activity, and the performance specifications for the test being conducted. Encouraging both questions and suggestions from the technician can establish the sense of teamwork and will gradually allow the staff member to answer questions from clinic staff and clients on behalf of the andrology laboratory.

4.2 Inter-technician QC

In addition to formal performance review, the inter-technician (intra-laboratory) variation should be monitored for each test. In particular, split sample testing should be conducted for sperm concentration, motility, and morphology. Multiple evaluations, involving splitting a single donor specimen for analysis by all technicians, can indicate if updated training is required. In fact, the process of side-by-side testing lends itself to on the spot training. For documentation purposes, note that there will be some random variation, and statistical analysis should be used to detect significant differences in the values obtained by different testing personnel.

Inter-technician differences can be detected over the long term by comparing results for patient samples, including replicate counts. Figure 3.1 shows the comparison of two technicians for determination of progressive motility and sperm concentration over a year of testing. The differences in values and in precision differed significantly between the technicians, and remedial action is required to determine the cause(s). Tables 7.2, 7.3, 7.4, and 7.5 in the WHO laboratory manual for the examination and processing of human semen [7] gives a list of sources of variation in assessing and proposed solutions for determination of sperm concentration, morphology, motility, and viability. Remedial action, including any training activities, should be documented with demonstration of the technician’s competence before he or she resumes patient testing.

Fig. 3.1
figure 1

Comparison between two technicians in values for sperm concentration and motility for 1 year. The left-hand columns (red) show box plots for the sperm measures and the right-hand columns (gold) show the coefficients of variation (CV) for the replicates each day. The figures include 367 patient specimens evaluated by technician 1 and 130 different patient specimens evaluated by technician 2. In all four plots, the difference between the 2 technicians was highly significant (p < 0.001; Kruskal-Wallis ANOVA on ranks). Technician 2 counted higher concentration and progressive motility with greater precision than technician 1

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Another method for tracking consistent performance by technicians is regular evaluation of daily QC activities, such as bead counts, sperm motility from videotapes, and sperm morphology counts, to detect inter-technician variation. If QC data are maintained in a database, this practice can be a routine analysis. For example, the inter-technician difference from the expected value and variation (SD; CV) can be calculated monthly. Values for counting latex beads are shown in Fig. 3.2 for two technicians that differ in the median counts.

Fig. 3.2
figure 2

Comparison between two technicians in values obtained for daily counts of latex beads for 1 year. Counts are for the same Makler chamber and the same lot of beads. Technician 1 counted beads on 146 days and technician 2 on 127 days. Technician 2 obtained significantly higher values for both high (blue) and low (green) bead suspensions (p < 0.001; Kruskal-Wallis ANOVA on ranks)

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4.3 Formal Performance Evaluations

Each laboratory requires SOPs for formal performance evaluation of personnel and documentation of this activity. Ensure that policies and procedures are established for monitoring the expertise of individuals who conduct testing and to identify needs for remedial training or continuing education to improve skills if needed. Formal evaluations should be more frequent for new employees and be conducted at least annually for all staff.

The annual performance evaluation should involve the employee, his or her supervisor, and the laboratory director. The criteria should sum up the routine process of personnel assessment, including the worker’s growth and progress. It should be consistent and supportive of other documentation used to describe employee performance. Table 3.2 is the form used in the author’s laboratory.

Table 3.2 Sample annual employee competency evaluation form
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Producing quality results with satisfied clients and patients is impossible without competent laboratory staff. Ensuring the competency of andrology laboratory personnel is an active, ongoing process that includes the entire laboratory team. Establishing and maintaining a culture of quality that involves each staff member will improve pride in the laboratory, job satisfaction, and retention of competent employees.