Running a school laboratory, a couple of decades ago was easy. It didn’t really matter if the pupils’ equipment was faulty, as the pupils’ experiments were very much a hit-and-miss affair! Mainly because teenagers have an aversion to following instructions.
Of course, the teacher’s experiment is the fall back for when the pupils’ experiments didn’t work, mine HAD to function. The golden rule was, “Don’t put broken equipment back in the cupboard! Put it on the back bench and tell me!” I implemented this, because discovering 5 minutes before a lesson that half the equipment didn’t work was a disaster.
There are some lessons here that fall into the category of fit for purpose aspects of laboratory quality control. There is also servicing and maintenance aspects. The scrum and jumble of a school lab is far removed from the mission-focussed high-tech lab needed in an IVF clinic.
A well-maintained laboratory utilising equipment that is fit for purpose is a prerequisite for a functioning IVF clinic. But laboratory equipment quality control is an area, which can be fraught with difficulty. There is little guidance on things like depth and frequency of service intervals.
Equipment categories
A good starting point is to categorise all the equipment that the laboratory uses, breaking it down into two sub-lists:
- Standard laboratory equipment: everything that is needed for the normal running of a generic diagnostic pathology laboratory. Look at centrifuges, fridge/freezers, pipettes, balances, safety cabinets and microscopes
- Specialist equipment/systems: laboratory items that are specific to an IVF clinic. Look at culture incubators, uninterrupted power supply systems, gas monitoring systems/alarms and cryo-systems.
For standard laboratory equipment it is good practice to adopt the best documented quality control (QC) procedures that are available. A good national example of one of these is the Australian NATA General Equipment Calibration and Checks Document1. This provides excellent guidance on the frequency and depth of some common equipment checks.
Adopting nationally established QC procedures for standard equipment forms the basic level of quality control. From there the specialist equipment can be added in. The QC framework for specialist equipment will require in-depth knowledge of each piece of equipment based on the manufacturer’s recommendations. Together with a risk-analysis, based on the specific role of that equipment within the laboratory.
Servicing and calibration are not the only items to consider in a QC document. Another important area of consideration is ensuring that equipment is fit for purpose on the actual day of use. This implies some degree of daily testing. For instance, it is not acceptable to leave a warmed surface for six months without testing by the user of that surface. A laboratory QC standard would ensure that all work surfaces and tube-warmers are tested before use. This ensures the temperature is correct on the day of use.
Methodology
Once the equipment has been categorised in order to be checked, serviced and calibrated, it is important to have a methodology for testing the equipment in place. This is usually a mathematical base for eliminating error and increasing accuracy.
Happily, tried and tested methodologies are available, which have covered the error margins for all kinds of standard equipment. They are easily located and are usually endorsed by the national measurements’ institutes of various countries. Sometimes even a supranational body such as the World Health Organisation2. Another good example is Australia’s NATA (National Association of Testing Authorities), which provides a series of NATA Technical Notes3.
Methodologies for specialist equipment that are serviced by external providers fall outside the remit of the laboratory staff. A duplicate record of any servicing or maintenance provided by external organisations will need to be kept. You should also monitor the frequency to ensure that service intervals are not overlooked by the external provider.
With regard to external providers, it may also be necessary according to your own risk assessments to request additional services. You may require servicing and maintenance above and beyond what would normally be provided by those suppliers. For risk management, you might want 6 monthly assessments of uninterrupted power systems battery life instead of yearly assessments.
Documenting laboratory equipment quality control
There is a simple rule of technical documentation, which is applicable to every high-tech industry from chemical engineering to aircraft engine manufacturing.
It is, ‘No documentation = no proof.’
From this assertion comes the warning to assume that, without documentation, the test, calibration or service in question has NOT been undertaken.
All worksheets and calibration reports should have clear PASS/FAIL levels documented on them. And where applicable, ranges of acceptable performance such as temperature ranges. This ensures that checking staff immediately know when an item is not performing acceptably. They are in then in a position to bring this to the attention of the laboratory manager formally.
I’ve already mentioned that external providers should provide a duplicate record of their servicing and maintenance to the laboratory manager. However, it is also worth mentioning that providers should be chosen that carry appropriate certificates from a national testing authority. Alternatively, they may be accredited to an international standard such as ISO170254.
Documentation at key stages and as often as possible needs to be countersigned at the point of checking. The simple reason for this is human error. Staff are human and therefore they will occasionally make errors, so will supervisors and lab managers and directors! A countersigning process involving two people halves the chance of human error. This should not be a rubber-stamping exercise, which would simply negate the point of having a second person sign off. This is why the sign off needs to happen at the point of checking, so that two people AGREE on the results.
I started this blog talking about my experiences as a science teacher in a school lab. I mentioned a couple of lessons that could be learned across both school laboratories and IVF laboratories. So, to finish I’d like to highlight another important lesson.
In schools, lab management was largely about saving money and why equipment was not routinely kept in top condition. If something broke, we would make do or do without until such time as it could be replaced.
In the IVF laboratory the business aim is to make babies!
Success can’t be achieved by saving money at every turn! Ultimately, good laboratory quality assurance practice is about reducing risk and improving productivity. These two go hand in hand.
Neil Madden, Editor
The Fertility Hub
References
- National Association of Testing Authorities. 2014. Medical testing field application document: general equipment calibration and checks. http://www.nata.au
- World Health Organisation. 2008. Maintenance manual for laboratory equipment. 2nd Edition. ISBN 978 92 4 159635
- NATA 2014. Example: ‘Technical Note. User checks and maintenance of laboratory balances. http://nata.com.au
- ISO/IEC 17025. 2005. General requirements for the competence of testing and calibration laboratories. https://www.iso.org
