Risk reduction strategies in the IVF laboratory setting – PART ONE

Standards and staffing

Risk is inherent in IVF at every stage of the process of artificially enhancing human reproduction by use of technology. And even in a natural environment conception, pregnancy and delivery are still risky endeavours. Obviously, intervening in those processes in the context of an IVF laboratory raises the risk further.

I won’t patronise you by listing examples of the risk inherent in providing ART (assisted reproduction technology) services! In terms of an IVF laboratory, we can look at broad areas where we can employ risk lowering strategies.

These might include:

• Areas of high risk versus areas of low risk
• Efficient practices versus inefficient practices
• Dealing with known problems effectively so as to lower risk
• Ensuring that equipment performance is optimal
• Ensuring that processes run smoothly and that there are maintenance checks in place to ensure quality control
• Ensuring that things happen when and how they are meant to happen as a matter of routine
• Using benchmarking and laboratory performance metrics

Total quality management: TQM

We talked before about the idea of total quality management, and many aspects of this are applicable in the clinical laboratory setting.

IVF laboratories have specialised functions that set them aside from other industries. Although there are generic rules for good practice that apply to all industrial laboratories. One of these generic rules for reducing laboratory risk is to find an internationally recognised set of high standards. Then the goal is to exceed or at least match those standards. Of course, in terms of IVF laboratories, most clinics will follow some form of national Code of Practice. This code requires training and aspects of laboratory quality control (QC). But this is usually quite broad and come with limited documentation requirements.

International standards differ from national standards in that they formalise the QC and quality management systems required by national accreditation programmes. A good generic example, applicable to many types of businesses and laboratories, including IVF clinics is ISO9001¹. This international standard is useful for ensuring that all areas of the clinic are operating to a high international standard, but it doesn’t include documentation for frequency and type of QC calibration.

A more specific example, particularly for medical pathology laboratories is ISO15189², which exemplifies a level of technical competence.

It also aims to reduce risk by:

• Minimising laboratory errors
• Assessing qualifications, experience and training of staff
• Ensuring maintenance and calibration of equipment
• Implementing quality assurance procedures
• Ensuring high quality sampling processes

Follow national and international standards

By following the national standards and international standards, it is possible to start controlling laboratory risk at a basic level.

At this level it is possible to:

• Identify outdated practices (procedures, documents, forms, consents, policies etc)
• Ensure staff are trained, and that ongoing training is maintained
• Implement techniques to reduce sample errors
• Ensure equipment is fit for purpose, calibrated, routinely checked and maintained
• Ensures continuing education, staff development, and managerial processes are adequate

But are national accreditation systems and international standards enough to avoid error. After all, laboratories are human organisations and humans make errors.

How, after implementing good standards, can we minimise human error?

Laboratory staffing

The answer to minimising human error is to look at aspects of staffing.

Having good staff in key positions is a prerequisite for minimising error in laboratories with multiple outputs and specialist techniques. Most clinics will have a laboratory director who is responsible to the board for laboratory performance. But the laboratory director cannot be in all places at once. Therefore, each laboratory or department within a major laboratory, needs a laboratory supervisor. This is a key position, and requires a person who can give feedback, assess technical decisions and suggest alternative methods.

The laboratory supervisor shouldn’t be scared of new ideas and whose knowledge can be translated into feasibility at the bench. They will lead to determine and implement staff training in new techniques and procedures.

In terms of risk management, the laboratory supervisor will have a key role in empowering staff. They discuss and look out for risks during routine laboratory tasks. The laboratory supervisor will take the lead and write standard operating procedures from a risk management perspective. Staff should be invited to review content, discuss the process and give their thoughts on aspects of safety.

Staffing numbers and risk

 Working out staffing levels for a laboratory is not a simple process! You can’t just break down the number of yearly cycles and divide it by the number of staff. However, in the current climate, a a full-time embryologist may be required for every 125 cycles performed³.

This figure is influenced by:

• Techniques and processes in use (complexity of task, type of identity witnessing etc)
• Skill levels of staff
• Hours per week worked by staff
• Economies of scale
• Other tasks undertaken by staff in the laboratory (e.g. diagnostic work)

Staff need to be engaged, able to concentrate, and free from tiredness so as to not make fatigue-based errors. This must also guide staffing ratios. With this in mind it is helpful to have rules in place:

1. Guidance on how many consecutive days a staff member should be at work.
2. Guidance on break times. Have rules on the longest continuous stretch of concentration to which employees be subjected (usually 3 hours max).
3. Guidance on where break times should be taken. This should always be outside of the laboratory so that a clear break environment is an integral part of the break.
4. Guidance on what tasks are permitted according to the specific employee’s daily schedule. It’s worth scheduling lower risk tasks for later in the working day, when employee concentration is at its lowest ebb.

Be rigorous about breaks!

It may seem controlling to rigorously things like staff breaks! But it is an easy way to start to manage one of the main factors in human error: fatigue.

Risk is inherent in IVF, and these strategies both that of setting standards and managing/allocating staff are not one-off exercises. They are ongoing and have cost implications. For instance, it is certainly possible to get more hours of work from staff than many fatigue-reducing rotas may allow. But the consequences of ignoring risk in IVF are too severe to be countenanced in a sustainable IVF business.

References:

1. International Standards Organisation. ISO9001. 2008. https://www.iso.org/publication/PUB100080.html
2. International Standards Organisation. ISO15189. 2015. https://www.iso.org/standard/56115.html
3. Mortimer, D et al. 2005. Quality and risk management in the IVF laboratory. P.48. Cambridge University Press. ISBN 0-521-84349-9

 

Neil Madden, Editor

The Fertility Hub