Increased focus on risk management in the revised ISO 15189:2022 – Medical Laboratories – Requirements for quality and compliance

Introduction

In December 2022, the ISO 15189:2022 – Medical Laboratories – Requirements for quality and competence was published. This standard replaces the ISO 15189:2012. The revised standard is patient focused, risk based and takes a less prescriptive approach to give medical laboratories more flexibility in how they meet the requirements. Medical laboratories will have to transition to the new standard by 6^th December 2025.

In Ireland, the Irish National Accreditation Board (INAB) have confirmed they will accept new laboratory applications for accreditation of ISO 15189:2022 from July 2023. INAB aims to begin the transition of existing accredited laboratories to ISO 15189:2022 in January 2024.

In this blog, we review some of the significant changes, focusing on the risk management element, and how you can utilise a laboratory QMS to meet the new laboratory accreditation requirements.

What is the ISO 15189:2022?

ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories. The standard is applicable to medical laboratories in developing their quality management systems (QMS) and assessing their competence. Its objective is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories. The standard contains the minimum requirements for quality and competence and services are encouraged to recognise this and strive for continuous quality improvement.

What are the key changes to the ISO 15189:2022?

There are three significant changes made to the ISO 15189:2022 standards, these include:

• The alignment to the ISO17025:2017.
• The requirement for a point-of-care testing (POCT), previously in ISO 22870, have now been incorporated in the main standard.
• An increased emphasis on risk management.

Increased focus on Risk Management

Throughout the ISO 15189:2022 document there are requirements that are intended to ensure that the risk to patients is a central focus to the laboratory QMS. Not only does the document places a greater emphasis on risk, it also includes a greater emphasis on the opportunities for improvement that will come from taking a more risk-based approach. Medical laboratories should be developing and improving systems to the benefit of the patient.

The Benefits of a Quality Management Information System

ISO 15189 is of vital importance for medical laboratories because it is a globally recognised laboratory accreditation. It provides assurances as to the reliability, competence and quality of a laboratory’s practices.

As per 8.1.1 of the ISO 15189:2022, laboratories shall establish, document, implement and maintain a management system to support and demonstrate the consistent fulfilment of the requirements of the standards. A Quality Management System is an effective tool to do this.  Electronic solutions such as Q-Pulse, Quality Management Information System (QMIS), are much more effective and reliable than paper-based solutions. The QMIS allows the laboratory to put in place processes for the effective management of laboratory accreditation requirements, as well as maintain and improve quality management processes such as document control, audits, incident and risk management, corrective and preventive action and quality improvement planning.

Throughout the document, there are many requirements for laboratories to engage in proactive risk management to reduce risks to the patient and drive quality improvement within the laboratory. Under 5.6 Risk Management, the ISO 15189:2022 states Laboratory management shall establish, implement, and maintain processes for identifying risks of harm to patients and opportunities for improved patient care associated with its examinations and activities, and develop actions to address both risks and opportunities for improvement. Given the increased emphasis on risk within the revised ISO 15189, laboratories should consider utilising the Q-Pulse IMS Module to manage the enhanced risk requirements. This will not only enable laboratories to improve the management of ISO 15189 activities but will enhance quality and patient safety.

Below are some of the features and benefits that laboratories can harness when utilising Q-Pulse to manage risks:

1. User Friendly Risk Identification Forms

A key benefit of utilising a system such as Q-Pulse, is that reporting forms for risks, incidents and opportunities for improvement can be bespoke and customised to your laboratory’s requirements. During the process mapping phase, HCI will identify the appropriate classification requirements for your forms which will make it easier for staff when recording and reporting on risks.

2. Conduct Risk Assessments

Once a risk has been recorded within Q-Pulse, the appropriate person will be notified by email alert, and they can then manage the risk within Q-Pulse. For example, under 7. Process Requirements of the ISO 15189:2022 standard, the laboratory is required to identify potential risks to patient care in the pre-examination, examination and post-examination processes. These risks shall be assessed and mitigated to the extent possible. Q-Pulse is an effective tool to record and manage these risks as staff have the ability to conduct a risk assessment, assign a risk rating, identify controls and any further actions required.

3. Mitigate Risk Through Quality Improvement Planning

As per 8.5.2 Acting on risks and opportunities for improvement, the ISO 15189:2022 states, the laboratory shall record decisions made and actions taken on risks and opportunities. This can be demonstrated within the risk record on Q-Pulse. The risk owner can identify and assign the necessary controls or actions required to manage the risks and reduce the likelihood of an incident or risk occurring. Once an action is assigned to a staff, this staff member will receive an email notification alerting them to their responsibility. This helps to ensure that risks are managed appropriately, timely and effectively.

4. Reporting on Risks

Q-Pulse allows you to run real time reports and advanced searches to identify risks by their status (open/closed/pending), the risk rating, the owner or event date. This is useful when reporting and managing risks and your risk responsibilities. These reports or advanced search views in Q-Pulse can be saved and viewed later.

Conclusion

The revised ISO 15189:2022 contains enhanced requirements for medical laboratories to plan and implement actions to address risks, especially risks to the patients, and opportunities for improvement. In response, laboratories must implement a quality management system which supports a risk-based approach.  

For almost two decades, HCI have supported health and social care providers to implement Quality Management Information Systems which help to digitally transform their quality and safety processes. As Ideagen’s healthcare partners in Ireland, HCI provide a complete support service for Q-Pulse clients in the Republic of Ireland and Northern Ireland.  HCI can provide you with comprehensive support in implementing the Q-Pulse IMS Module, ensuring that your system is set up to meet the requirements of revised ISO 15189:2022.

If you would like more information or a demo of Q-Pulse contact HCI at +353 (0)1 629 2559 or email info@hci.care.