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A journey through ISO accreditation

by: Marie-Hélène Bouchard

To set the scene, in 2018 we learned that in Quebec, Accreditation Canada would no longer accredit transfusion medicine. The laboratories would be accredited respectively by ISO 15189, ISO 22870 (point of care testing) and of course a more familiar standard CSAZ902 for transfusion medicine. So far, no big deal. We are used to the different standards: Z902, CSTM standard (which do a great job), the blood regulations or the Vanessa laws, nothing could go wrong, right?
Well, for those who have more experience than me, you will probably guess that I was wrong.
Our first assessment to ISO 15189 took place in 2019-10
Verification, Validation:

The first culture shock with the ISO standard is certainly the analytical verification and validation documentations. To briefly summarize, 15189 is closely linked to your analytical offering as well as the analysis method used. This therefore means that your analysis must have a complete verification file specifying the parameters evaluated (concordance, precision, detection limit, evaluation of sources of uncertainty), the results to be achieved as well as confirmation that the results were achieved. (7.3.2 ISO 15189-2022). Depending on whether the analysis is qualitative or quantitative the parameters evaluate will vary.

Obviously when we change reagents or analyzers, we all make comparisons. If you're lucky you might even still have the initial data collection hidden somewhere in a dusty box, but did you specify the criteria evaluated? Have we assessed risk management (using the 5M method for example)? Or worse ! Did the specialist sign the verification report before going into production? This probably isn't always the case.

And what do we do with the analyses that came out long before we graduated?

Well, they are not exempt from the verification process. The verification can be produced from internal and external control data collection done over time.
Another important point to bear in mind (which historically was not always considered) is the adherence of the method to the manufacturer’s monograph. Because if we don’t respect the manufacturer’s monograph then we need to fallow ISO 7.3.3 and have to produce a validation file that has more criteria. So if we dilute antisera or commercial cells we must always ask ourselves the question if it is a practice covered by the validations of the manufacturer.
For more information about verification and validation:
CLSI EP12 Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition
COFRAQ SH GTA 04 Guide technique d'accréditation de vérification (portée A) / validation (portée B) des méthodes de biologie médicale

Training and competency assessment:

Another issue that has been a big challenge is the issue of competency assessment. As stated in CSA the laboratory must have a competency assessment program at the end of the training and then at regular intervals.
During the first wave of accreditation the skills maintenance program was often deficient in the laboratory and as transfusion medicine is also audited for Z902 it was therefore necessary to include the clinical staff. The hours of continuous training and self-assessment from our professional orders did not exempt us from this program.

So it was in partnership with the care units that we had to work hard to produce training and competency assessment programs for the clinical staff. This collaborative work is not without difficulties since It implies different units, different directions different departments head who are also understaffed and juggling their own priorities.

So many years later we did overcome the challenge and the those programs keep moving and keep going even if some job titles are still missing (ex: transfusion safety officer)
External Quality Assessment (EQA):

Standards Council of Canada has strict criteria for EQA coverage. If no EQA is available an alternative approach should be performed.

During our first accreditations the list of analyses to be controlled was not always clear, especially for enzymatic treatments (Ega-KIT, WARM). It is important to clearly define the analyses to be part of the analytical scope VS the treatments that are not an analysis in themselves. (However, they must be integrated into the audit files, since they are part of a sub-process of an analysis).

Another novelty for EQA with ISO is that before starting an analysis we must pass EQA before it available for use - arule that was not systematically followed before.

For more information on SCC coverage see: https://scc-ccn.ca/resources/publications/requirements-and-guidance-proficiency-testing-testing-and-medical
A standard of proofs:

Of course, we all do an excellent job! But how to prove it?

This is a major change with our former accrediting body, we had to provide proof that we met the standard on everything. You have a recipient notification process? Sure !  but how to prove that the patient  has actually been notified? Have you implemented a corrective action? How can you verify its effectiveness?

Iso accreditation requires a significant documentation effort and ideally a clear structure so that we can quickly find when we are audited. This documentation adds to the bureaucracy of our quality system. Fortunately the COVID 19 pandemic allowed us to get acquainted with many new collaborative technological tools that facilitates the task.
What about the new standard?

The ISO standards have a very close connection with risk management so it is not surprising that the new 15189 , that comes out in  2022,puts a lot of emphasis on risk management.

Intuitively we all do risk management in our daily activities. We will regularly decide to put measures in place to mitigate a greater risk or ignore another with small impact. In ISO 15189 we are asked to take a more systematic approach to risk.

We need to map our risks in our processes, assess them and put controls in place as needed. If nevertheless there are residual risks it must be communicated to users.

So this is a much more structured approach to risk management. Although there are many risk management tools available some have opted for the risk matrix.

Even once we adopted the risk matrix there are different models available the simplest being the one based on the calculation of impact and probability.
There are always challenges:
  • The fact that the rest of the hospital is still Accreditation Canada is definitely a challenge. Since we do not all have the same accreditors, a non-compliance for an entire hospital compared to a non-compliance for only transfusion medicine and the laboratory do not have the same weight according to management. It is not always easy to get other directors to implement new processes for non-compliance of an accreditation that does not directly affect them.
  • Another challenge is that while quality structures have adapted locally with the addition of some job titles including specialists, there is no uniform structure imposed, so additional resources may vary from place to place.
  • ISO is very strong in risk management, but the risk can exist from beginning to end. Overall, it is a very good improvement to ensure that all our employees have enough support when providing patient care that we perform better analytical verification, but at first, it all starts with a prescription of blood products. All efforts invested downstream are useless if the criteria of relevance - transfusion thresholds and choosing wisely criteria - are not applied upstream. Transfusions present a residual risk, it is also important to avoid unnecessary transfusions.
In conclusion:

Overall, ISO accreditation has brought a nice improvement: better verification of analysis, more competency assessment, more paperwork (sigh), a more robust risk management and impact analysis structure, but all accreditations have their strengths and ultimately we need to learn from each to provide better care for our patients.

It was both an arduous and rewarding experience.

Our quality systems have adapted to change and modified their structure to meet this high quality standard.

Although accreditation presented challenges, nothing is insurmountable, and our quality teams came through with flying colors.


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