Recently announced changes to the ISO 15189 standards for clinical laboratories place more focus on the patient, including an emphasis on mitigating risk, and take a less prescriptive approach to standards to give clinical labs more flexibility in how they meet the requirements.
What is ISO 15189?
ISO 15189 is an international standard that specifies requirements for competency and quality that are particular to medical laboratories. It was developed by the International Organization for Standardization in 2003 and has been revised several times since. While ISO 15189 accreditation is voluntary, the accreditation is considered a mark of excellence and is recognized globally. There are several organizations in the US that have the authority to confer ISO 15189 accreditation, including the American Association for Laboratory Accreditation (A2LA) and the College of American Pathologists (CAP). There are thousands of clinical laboratories that currently have ISO 15189 accreditation worldwide, including about 100 in the US.
"While ISO 15189 accreditation is voluntary, the accreditation is considered a mark of excellence and is recognized globally."
How has ISO 15189 changed?
The fourth edition of ISO 15189, published December 6, 2022, was developed over the past four years by a team of experts from around the world. According to Randy Querry, director of government relations for A2LA, who participated in the workgroup, more than 96 people from around the world participated in developing the revised standards. A core drafting team from Canada, the US, UK, the Netherlands, France, South Africa, Singapore, and Australia revised the initial draft, which was then shared with the full working group for feedback. This product received about 1,400 comments. The participants held Zoom meetings to discuss the various iterations of the revisions.
“The revised standards are less prescriptive and give labs more leverage in how they do a specific task, as long as the outcome is the same,” says Querry. For example, while there are still “shall” and “should” statements, there is a greater use of qualifiers after “shall” statements, such as the addition of the phrase “as appropriate.” This gives labs leeway to determine what is appropriate for their circumstances and gives them flexibility to justify why a particular requirement was not met.
The overall framework has also greatly changed, says Querry. The previous versions had two main sections—management and technical. The new structure follows other ISO standards, where there are five main sections: general, structural, resource, process, and management system. “This should make it easier for the lab and users to find information,” he says.
According to A2LA, clinical labs will have three years to transition from the current standard to the revised standard, which should provide laboratories with sufficient time to prepare to upgrade new requirements while maintaining their existing requirements.
The new ISO 15189 standard focuses on risk
The new standard is risk-based and patient-focused and encourages continuous improvement within clinical laboratories. Throughout the document there are requirements that are designed to ensure the risk to patients is central to the ethos of the laboratory’s quality management design and processes.
“Embrace the four-letter word: RISK,” advises Querry. “This is all about risk management. It is new to the standard and in fact the word ‘risk’ shows up in the standard 85 times. Labs should consider risk in all processes—document control, handling of samples, how they issue test results. Risk is so entwined in the standard that it should be at the top of the lab manager’s thought process.”
For example, given the problems with supply chains in the past two years, clinical labs should consider the risk of relying on a sole vendor for supplies, says Querry. “Instead of having one supplier of solutions, labs might want to have a backup or several backups.”
Margaret Coppin, quality officer for ARUP Laboratories (Salt Lake City, UT), says the emphasis on risk management will prompt the organization to think more broadly about areas where improvements can be made. ARUP already conducts internal quality management systems audits but will tweak those audits to ensure they go beyond just ticking the boxes. ARUP has had ISO 15189 accreditation since 2017.
Transitioning to the new ISO 15189 standard
“The new ISO standard is giving us some ideas for more creative ways to think about risk management,” says Coppin. “Every individual section of the lab monitors their own trends with non-conforming events. We can use non-conforming event data to identify opportunities for improvement and develop quality improvement projects around one of those trends.”
According to CAP, routine activities can reveal risks, including internal audits, everyday observation, occurrence management, proficiency testing, quality control, and new, significantly revised, or complex processes. Both CAP and A2LA offer training on how to comply with ISO 15189 standards.
"Clinical labs will have three years to transition from the current standard to the revised standard."
Kevin Lawson, president and CEO of KSL Diagnostics (Buffalo, NY), the first A2LA ISO 15189 certified laboratory in New York State, says the new requirements of 15189, including risk management and more detailed policies and procedures related to instrumentation, safeguards, and adverse incident reporting, are already largely integrated into KSL’s current systems and will be confirmed through a gap assessment and subsequent internal and external audits.
“Our familiarity and compliance with other standards such as ISO 14971 and ISO 13485 prompted KSL to take a risk-based approach and incorporate all policies and procedures under our formal quality manual,” says Lawson. “Most of the changes KSL needs to implement for compliance with the new standard are simple text changes reflecting the new 15189 standard. These will be implemented in the short term for assessment in our next 15189 audit.”
Point-of-care testing and patient care
The new version of ISO 15189 includes requirements for point-of-care testing (POCT), which was previously contained in a separate standard, ISO 22870 (which will now be withdrawn). Overall, the revisions to the standards focus squarely on patient care, from collecting and processing samples to results reporting.
"The ISO 15189 revisions underline the importance of continually improving quality standards."
“We need to focus on patient care,” says Querry. “It’s not just a test result, but it’s something that impacts an actual person at the end of the day. I think the standard does a good job of ensuring that labs keep patient care in mind as they designed their processes.”
With POCT now integral to this standard, laboratory-supported POCT should be included in the scope of a lab’s quality management system and should follow the requirement of the standard.
ISO 15189 champions continuous improvement
The ISO 15189 revisions underline the importance of continually improving quality standards.
The added flexibility to allow for clinically justifiable variation to these standards is important to ensure that medical laboratories can strive toward and meet the needs of patients within a fully accredited framework, according to the Association for Clinical Biochemistry & Laboratory Medicine (ACB), an organization based in the UK. It recommends that clinical laboratories with ISO 15189 accreditation perform a gap analysis, reviewing their local quality management system against the requirements of the new standard.
“This gap analysis must involve input from the wide range of laboratory staff, including staff in clinical advisory and interpretation roles due to the importance of clinical decision making in many of the clauses,” says the ACB.