Mandatory procedures of ISO 15189:2022 – Part 2

Here’s the second part of the essential procedures you should consider when applying the ISO 15189:2022 standard in your clinical laboratory.

Ensuring compliance with ISO 15189:2022 requires laboratories to establish well-defined procedures that guarantee accuracy, reliability, and efficiency in their operations. In this second part of our series on mandatory procedures, we will explore key processes that clinical laboratories must implement to meet the standard’s requirements. From handling delayed test results to managing automated result selection and emergency preparedness, each procedure plays a vital role in maintaining quality and patient safety.

By following these structured guidelines, laboratories can enhance operational efficiency while ensuring regulatory compliance. This article will break down the essential steps for implementing these procedures effectively, helping your lab streamline workflows, reduce errors, and maintain transparency in test result management. Let’s dive into the details of these critical ISO 15189:2022 requirements!

Let´s begin!

Procedure for notifying users when analysis results are delayed – Section 7.4.1.1b of ISO 15189:2022

This procedure should include the following aspects:

• Try to set expected turnaround times in order to establish clear deadlines for when the results should be delivered and determine what qualifies as a delay.

• Determine who gets notified to figure out which users need to be contacted if a result is late like those patient care or anyone who requested the test.

• Establish your notification method to alert users by phone, email, or text message, and set rules for when each method should be used.

• Deliver roles and responsibilities to clearly stay who monitors the test status, who decides when it´s time to notify users, and who actually sends the notifications.

• Set up notification details to make sure it has the test ID, the delay reason, a new estimated delivery date, and a contact info for any follow up questions.

• It is important to implement control measures to set up safeguards to keep the information safe and reduce errors like tracking who sends each notification and logging everything in a follow-up system.

In addition, you need to remember to keep records of any of delays and the notifications sent, taking into account the date the delay was spotted, its cause, and the new expected delivery date.

Procedure for releasing results – Section 7.4.1.2 of ISO 15189:2022

This procedure needs to have at least the following aspects:

• Establish the release criteria in order to define what conditions must be met for test results to be released. These criteria should be based on manufacturer specifications for equipment and reagents, as well as legal, regulatory, clinical, and epidemiological standards.

• The identification of the key players is important to determine who´s responsible for releasing the results- this includes lab staff, clinical personnel, and management- and set up a clear, step-by-step communication process among them.

• Create a detailed step-by-step plan to release the results when they meet the criteria. This should include

1. Pinpointing which results are ready for release.
2. Verifying the accuracy and precision of these results.
3. Checking for any test interferences.
4. Having authorized personnel review the results.
5. Notifying clinical care providers and patients according to established protocols.
6. Documenting every action taken in detail.

You should also keep the records of all the review, verification, approval, and release activities, incorporating the dates, responsible individuals, and any other important details.

Escalation process – Clause 7.4.1.3c of ISO 15189:2022

This process should have at least the following aspects:

• The first step is to establish the escalation criteria to identify when a test result warrants escalation. These criteria need to be based on clinical and epidemiological considerations, and the specifications provided by equipment and reagent manufactures too.

• Then, it is important to determine responsible personnel to identify the individuals in charge of the escalation process, incorporating laboratory staff, clinical and management personnel. Set up a clear and efficient communication system between these groups to create a good environmental space.

• Finally, you need to define the escalation procedure to ensure proper handling when escalation criteria are met. This should include:

1. Recognizing test results that require escalation.
2. Informing relevant clinical and management personnel according to predefined protocols.
3. Investigating potential causes of the abnormal result and determining appropriate corrective actions.
4. Assessing whether the test should be repeated or if additional tests are necessary.
5. Recording all steps and actions taken in detail.

Additionally, you should maintain comprehensive records of the entire process from issue identification and evaluation to escalation, resolution, and verification. The documentation should include dates, names of responsible personnel, and any other pertinent information.

How to handle automated result selection, review, release, and reporting – ISO 15189:2022 (Clause 7.4.1.5)

If your lab wants to automate the process of handling test results, here’s what you should do:

• You need to choose the right analysis methods and information systems that support an automated workflow for selecting, reviewing, approving and reporting test results.

• It is important to establish clear criteria for selecting, reviewing, and approving results, taking into account this:

1. Equipment and reagent specifications provided by manufacturers
2. Legal and regulatory requirements
3. Clinical and epidemiological guidelines

• You should implement a detailed step-by-step process that also includes protocols for handling results that do not meet the established criteria. This process should include:

1. Selecting and recording test results
2. Automated review and flagging of deviations
3. Identifying possible causes of deviations and corrective actions
4. Automatic approval and notification of clinical staff and patients as per protocols
5. Maintaining comprehensive records of all actions taken

• Implement a structured process to create an automated result reporting, specifying how test reports are generated and delivered to clinical staff and patients.

• Guarantee detailed documentation of every stage-selection, review, verification, approval, release, and reporting. Each report should have:

1. Date of the activity
2. Name of the responsible individual
3. Any other relevant details

By considering these steps, your lab can enhance accuracy, maintain compliance, and improve efficiency while ensuring proper documentation of every process.

Managing changes to reported results – ISO 15189:2022 (Clause 7.4.1.8)

If a reported result needs to be corrected or updated, the process should follow at least the next aspects:

• First, when modifications are allowed, you should outline the scenarios where changes may be necessary, like patient identification mistakes, results that conflict with medical history, or values that fall outside the expected range.

• Deliver roles and responsibilities to define who in the lab team can request, execute, and improve result modifications to secure accountability.

• Try to keep a proper documentation and detailed record system where you have every modification request, including the original sample, initial result, reason for the change, and the revised outcome.

• Implement safeguards to ensure the data integrity and reliability of information by tracking who made the change, requiring approval, and logging all modifications in a traceable system.

• Create a structured review system to approve modifications and to guarantee they are done within a reasonable timeframe.

• Get in contact with those who requested the test and received the modified results, while keeping a record of the notification.

By having in mind these steps, adjustments to reported results remain clear, justified and properly documented.

Procedure for continuity planning and emergency preparedness – Clause 7.8 of ISO 15189:2022

This procedure should incorporate the following aspects:

• First of all, you need to identify possible threats or risks that could disrupt lab operations or interfere in the patient safety. This is related to natural disasters, power outages, supply shortages, and any other critical vulnerabilities.

• You should assess how well your lab can respond to emergencies. Also, define what resources, protocols and safeguards are useful to maintain operations, protect the patients and personnel to minimize the environmental impact.

• As a recommendation, you should develop a comprehensive continuity plan to ensure that your lab remains operational during crises. So, this needs to outline the next aspects:

1. Safety measures to protect staff, patients, and the environment.
2. Steps to sustain lab functions, including securing critical supplies and data recovery.
3. A clear communication plan to keep staff, patients, and stakeholders informed.
4. Emergency response strategies, such as evacuation protocols, injury management, and proper documentation.

• Finally, document all aspects of your emergency planning like risk evaluations, response plans, staff training, periodic reviews and drills or simulations.

A robust emergency preparedness plan ensures that your lab can navigate unexpected challenges while maintaining safety and service continuity.

Managing lab records- Clause 8.4.3 of ISO 15189:2022

It´s crucial to keep lab records organized and secure. So, your procedure should include:

• Identify essential records like test results, equipment calibration logs, maintenance records and staff training documentation.

• Establish what information needs to be recorded, the required format and how often updates are needed.

• Set up clear steps for recording, storing, reviewing, and safely disposing of records when no longer needed.

• Deliver specific roles to assure proper record creation, updates, and review, preventing mismanagement.

• Determine how long different records must be stored, taking into account legal regulations and lab polices.

• Try to implement protective measures to ensure security and confidentiality to avoid unauthorized access and accidental loss of records.

You need to properly document all record management aspects incorporating storage, tracking, privacy protection, and disposal. Each entry must have dates, responsible personnel, and any other relevant details.

Share this article with your friends if you find it interesting

See you soon!