Guidelines For Getting Ready For The Iso 15189:2022 Changes

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Medical laboratories must meet specific requirements for competence and quality, according to ISO 15189:2022. The ISO 15189 standard specifies the steps that must be planned and taken by the medical laboratory to manage the risks and opportunities for improvement. The ISO 15189:2022 standard establishes requirements for quality and competence in medical laboratories and now also covers the requirements for point-of-care testing. Point-of-care testing (POCT) is a type of examination in which the analysis is carried out close to or at the location of a patient. Accredited medical laboratories must adhere to this new standard through December 2025. Additionally, ISO 15189:

• Aims to develop a system that is failure-resistant, catching errors before they become a significant problem.
• Attempts to deliver accurate outcomes in a single attempt by cutting down on mistakes.
• Finds possibilities for laboratories to continually improve.
• Providing lab employees with ISO 15189:2022 Auditor training educates them with the necessary information and engages them in important problem-solving and solution ...
... implementation.

In 2003, the first edition of the ISO 15189 standard for medical labs was released. Later revisions introduced a section on laboratory information management systems in 2007, 2012, and 2022. Here are a few pointers to make the accreditation process robust and easy.

Pay close attention to the document's terms: The majority of your questions may likely be resolved with a careful review of the standard because it wasn't written to acquire anyone by surprise. You can be confident that every word has been analyzed and carefully picked for clarity.

Start by considering your procedures for the patient: The new standard puts a strong focus on the patient, therefore nothing you do or planned to achieve in your lab should be seen only in the context of your laboratory operations. Consider the patient's potential effects before acting. Do you face any risks regularly? How that risk might impact the patient should be the main concern. Is there a step you intend to include in the diagnostic procedure? How might the patient be affected by this new step? If you haven't already, it will be beneficial to adopt this patient-centered mindset as soon as feasible to facilitate a smooth transition to the revised ISO 15189 standard.

Keep in mind that the current emphasis is on being less prescriptive and on adapting the standard to the unique circumstances of your lab: You won't be required to comply with a portion of ISO 15189 if you can demonstrate that it's reasonable, even if it's not feasible or appropriate for your lab to do so. The best illustration of this is the new POCT (Point of Care Testing) annex. You do not need to comply with these requirements if your lab does not perform any patient-facing work. In other words, if some of the requirements of the standard aren't feasible or appropriate for your lab, you have the choice to justify. There is no one "correct" method to do something; it all comes down to defending your strategy and the risks it entails.

Not to worry! Remember that the 3-year transition period will begin on the publication date: You won't be required to achieve the updated standard in a matter of weeks or months, even though it would make sense to get things in order as quickly as possible to meet the new standard. This delay is being implemented to enable individuals some time to comprehend the new criteria, begin compiling evidence that they satisfy it, and open communication with their accrediting organization.

Make sure you are using a powerful QMS system or consider upgrading to it: Possibly your lab is still mostly documented. ISO 15189:2022 documents help to start mapping the changes that need. Anyhow, a strong QMS is the only way to become certified to ISO 15189 and keep it that way, and for the same reasons, this software will be essential for a seamless transition to the revised standard. The revised standard includes a greater focus on data protection, risk management, and looking for chances for advancement.