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23 June 2020

Why LIMS is crucial to achieving ISO 15189 accreditation

Tony Oliver

Pathology Programme Manager

About

Tony Oliver is a chartered scientist in virology with 30 years’ experience in the NHS. Having been a laboratory manager at various London teaching hospital virology departments, and run a software/consulting business, he spent 14 years as virology lead biomedical scientist/advanced practitioner at Bart’s Health. Professionally, he has participated in the IBMS Virology Scientific Advisory Panel, and spent more than ten years as a CPA/UKAS peer assessor. He has played a key role the implementation of many LIMS systems throughout his career, and has been a programme manager at Clinisys since 2017.

Gaining ISO 15189 accreditation is just the start of the hard work, says Tony Oliver, Programme Manager and laboratory accreditation expert at CliniSys. The ongoing accreditation process is a challenge that involves everyone in the lab, with LIMS at its heart.

It’s evident that LIMS systems are critical to the functioning of every lab – but relatively few people understand the technical workings of the system. Even fewer understand what is required to satisfy ISO 15189 LIMS standards, a situation that can cause problems when the annual accreditation assessment takes place.

Learn why LIMS is crucial to achieving ISO 15189, and the areas you should focus attention on.

Your Standards aren’t flexible

Let’s start with the basics. An accreditation standard is an objective and well-crafted statement of the requirements of the laboratory. There’s no room for flexibility or negotiation.

A requirement within as standard is not an option; it must be fulfilled. Here’s a real-life example:

“5.3 Laboratory equipment, reagents, and consumables

NOTE 1 For the purposes of this International Standard, laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems.

5.3.1 Equipment

5.3.1.1 General

The laboratory shall have a documented procedure for the selection, purchasing and management of equipment.”

The language here is unequivocal. You must have a documented procedure to hand. If it’s requested, you must be able to provide it – no if’s or but’s.

Assessors are likely to be peers, who understand the pressures of working in a laboratory. They are working from a presumption of innocence, not guilt. During an inspection, they’re not trying to catch you out, but they will recognise failures and raise them with you.

They want to see what procedures you have in place and what evidence there is to support your fulfilment of a standard. Increasingly, they’ll expect you to provide detailed written evidence to support your assertions – so bear that in mind when preparing for an inspection.

If you’re wondering where to start, the governance of LIMS system quality is covered by standards in sections 4 and 5.

Common LIMS errors

One of the most familiar LIMS-specific issues during an inspection is missing or incomplete documentation for systems. This includes both implementation and routine use.

The reasons are pretty typical. Over time, laboratory documentation can spiral out of control. A few documents can quickly become hundreds. Managing of this mountain of paperwork can eventually become impossible.

Laboratories have a habit of developing numerous small documents tailored to precise requirements. If you have 500 documents, you have to regularly review, store and manage 500 – which can become an onerous task. As a best practice, laboratories should seek to limit the number of documents they create. Not only will this reduce the documentary overhead, but it will also make it simpler to find the information you need during an inspection.

Spotlight on software

When it comes to software, laboratories must devote a significant amount of time to the validation and verification of changes to the system. This isn’t optional, it’s essential.

The systems and software you use in the laboratory are your responsibility. As a supplier, we maintain records of all software implementations, but these records will not cover decisions your organisation has made on changes. Ultimately, you are in control of the software – and must provide evidence if it’s requested.

During the assessment process, it can become apparent that senior managers and quality managers may not understand their LIMS sufficiently. This can result in a disconnect between the required standards and their interpretation in the real world. This divergence can lead to non-conformities. Similarly, laboratory IT managers may not be sufficiently well versed in how to achieve compliance with ISO standards.

In this situation, the knowledge, expertise, and evidence resides within the laboratory. It just needs to be unlocked through collaboration and communication between partners – ideally a long time before an assessment.

Continual quality

Within the laboratory, quality is often considered the Quality Manager’s job – but this is a mistake. Quality is everyone’s responsibility.

All staff who interact with the LIMS must understand the impact of Quality Control and Quality Assurance and the importance of governance of quality in the laboratory. Everyone must contribute to the documentation that safeguards, protects and improves quality.

When it comes to the LIMS system, specifically, you must identify an individual who understands both the importance of quality standards and the complex IT systems that power modern laboratories.

Ideally, this is a single person, but in many cases, a successful accreditation will involve the development of a close working relationship between the laboratory’s Quality Manager and the IT Lead.

Whoever is responsible for preparing the laboratory for its assessment, they must have the authority and confidence to lead and drive change.

Culture not process

The accreditation process is tough, but it is fair. You will be given a chance to prove yourself and be allowed to learn from your mistakes. But what happens when the assessors leave the laboratory?

Quality is about culture, not processes. If you can instil a commitment to excellence among all staff and an understanding of the critical importance of clear documentation, you’ll adhere to both the letter of the standards and their spirit.

5 tips for successful ISO 15189 accreditation

  • Read the exam question. If you can’t answer it, then there’s a gap that must be filled. Pay particular attention to the language used, for example, words such as “shall” or “documented procedure” carry particular significance. Always ask how will I prove compliance?
  • Ownership and recognition that LIMS is of enormous significance to the lab’s output.
  • Create as few documents as you can get away with.
  • Don’t wait. If you’re expecting an assessment, have all documentation ready as soon as possible. Preparation gives confidence.
  • If you believe you have satisfied the standard, make the point to the assessor, and provide the evidence.

Appendix A – ISO15189 Standards that impact on LIMS

4.13 Control of records
4.5.2 Provision of examination results
5.1.5 Training
5.2.2 Laboratory and office facilities
5.3 Laboratory equipment, reagents, and consumables
5.3.1 Equipment
5.3.1.1 General
5.3.1.2 Equipment acceptance testing
5.3.1.3 Equipment instructions for use
5.3.1.4 Equipment calibration and metrological traceability
5.3.1.5 Equipment maintenance and repair
5.3.1.6 Equipment adverse incident reporting
5.3.1.7 Equipment records
5.4.6 Sample reception
5.8 Reporting of results
5.8.1 General
5.8.2 Report attributes
5.8.3 Report content
5.9 Release of results
5.9.1 General
5.9.2 Automated selection and reporting of results
5.9.3 Revised reports
5.10 Laboratory information management
5.10.1 General
5.10.2 Authorities and responsibilities
5.10.3 Information system management