Bribes, conflicts of interest, blackmail, and corruption are not exclusive to the congress of your country; they also occur in a clinical laboratory more often than you might think.
To ensure that the activities of a clinical laboratory are objective, there is a powerful weapon called ISO 15189.
Today, you will learn what impartiality is, how to identify and manage risks to impartiality, and best of all, we will give you an example of an impartiality policy that you can implement right now in your clinical laboratory under ISO 15189.
Here we go!
What is impartiality according to ISO 15189 standard?
According to the ISO 15189 standard, impartiality is defined as follows:
“Objectivity with respect to the outcome of the tasks performed by the clinical laboratory.”
Based on the above, you should understand impartiality as the absence of any prejudice or influence that could affect the test results.
This means that the laboratory must take all necessary measures to ensure that its results are objective, reliable, and not biased by personal, commercial, or any other interests.
If you’re not one for technical definitions, here’s a more colloquial definition:
Impartiality is like a referee in a soccer match. It’s a neutral and impartial actor, who does not favor any team or player. It must follow the rules of the game at all times, even against its favorite team.
Types of risks to impartiality in the clinical laboratory.
Within the ISO 15189 standard, you can identify three categories of risks to impartiality: financial risks, personal risks, and external pressures. Below, we have summarized them and provided some examples of when they occur.
Financial risks:
Relationships with suppliers or sponsors: You should not favor certain suppliers or sponsors in the selection of reagents, equipment, or services, nor allow these relationships to influence test results.
Economic incentives: Your laboratory staff should not receive financial incentives or additional benefits for performing specific tests or favoring certain clients.
Conflicts of interest: Your laboratory staff must declare and properly manage any conflict of interest that could affect their ability to perform tests impartially.
Personal risks:
Friendship or family relationships: Your laboratory staff must not allow personal relationships with patients, doctors, or colleagues to influence the interpretation of results or the handling of samples.
Beliefs or personal biases: The personal beliefs, opinions, or biases of the laboratory staff should not influence the evaluation of samples or the interpretation of results.
Favoritism: It is the duty of your laboratory staff to maintain an impartial attitude and avoid any type of favoritism towards specific patients or doctors.
External pressures:
Influence of third parties: The autonomy and independence of your laboratory are fundamental pillars, so it must not allow external interests, such as those of pharmaceutical companies, politicians, or media, to interfere in the selection of testing methods, interpretation of results, or communication of these.
Threats or intimidation: Your laboratory staff must not be intimidated or pressured to manipulate results or falsify data.
Unfair competition: Your laboratory should not use unfair competitive practices to gain advantages over other laboratories.
Requirements of the ISO 15189:2022 standard related to Impartiality.
Among the most recent changes to the ISO 15189 standard, significant shifts have occurred. One of the fundamental changes is the focus on risk management, which includes the management of risks to impartiality.
To account for the sections where the standard refers to this topic, we have identified the main sections and present them to you briefly.
Clause 4.1. a)
This requirement informs you that the laboratory must carry out its activities impartially. Additionally, it specifies that the laboratory must be structured and organized in such a way as to ensure impartiality.
Clause 4.1. b)
It discusses the commitment that the laboratory management must have towards impartiality.
Clause 4.1. c)
This section establishes that your laboratory is responsible for conducting activities impartially, avoiding any type of external influence that jeopardizes your objectivity.
Clause 4.1. d)
This section addresses the duty to create a procedure to identify risks related to impartiality.
Clause 4.1. e)
This section complements item 4.1 d) by establishing the duty to assess and eliminate or minimize identified risks to bias.
Clause 6.2.1 item b)
This requirement establishes, among other things, the obligation of all laboratory personnel to act impartially and ethically.
How to implement an impartiality management program in a clinical laboratory step by step.
To meet the requirements of the ISO 15189 standard and ensure impartiality in the laboratory, it is necessary to implement a comprehensive program that includes the following steps:
Step 1: Impartiality Policy.
The impartiality policy is like a law created in Congress. It is the starting point to demonstrate compliance with the requirements regarding impartiality.
Within this stage, there are three fundamental secondary phases, which are:
Define principles and commitments.
When the first nations in the Americas were created, one of the first actions of the rulers was to create the political constitution. This established the laws that would govern all territories.
Similarly, the first thing we will do, before conquering impartiality, is to establish a clear and comprehensive policy.
In this policy, you must establish the necessary principles when complying with impartiality. They should be seen as a law of Congress, recognized and complied with by the staff.
Below, we provide you a template you can use to create your impartiality policy:
Template to define the impartiality policy:
“The Laboratory [the name of your laboratory] is not involved in any activity that could compromise its technical judgment. The Laboratory [the name of your laboratory] is not committed to any type of commercial, financial, or any other pressure exerted by any particular body that could influence its technical judgment or affect its competence and veracity.
Every new member of the staff must read and sign the laboratory’s ethical code declaration.”
This policy is based on a quality manual template provided by the World Health Organization (WHO).
Make sure to include a policy like this within the structure section of your quality manual.
Keep these additional considerations in mind when creating your impartiality policy.
- The impartiality policy must be adapted to the specific context of the laboratory and its activities.
- The language used in the policy should be clear, concise, and precise.
Communication to staff and stakeholders.
Once the quality policy is created, it must be communicated to all laboratory staff. We recommend that you set aside time in your laboratory’s schedule to inform everyone about it.
It is essential to have proper planning for this meeting to cover all relevant aspects and obtain the appropriate documentation or records.
Regular review and update.
This is a cross-cutting task in this guide. You must continuously review your policies to assess their compliance.
Identification and evaluation of risks.
Once you have created the impartiality policy in your quality manual, you must implement a procedure for identifying and evaluating risks to impartiality.
The first thing you should do in this step is related to the identification of risks to impartiality. It is possible to find these risks by implementing one or several of the following tools:
SWOT Analysis: This is a useful tool for identifying biases that affect impartiality in decision-making. It analyzes the strengths, opportunities, weaknesses, and threats faced by an organization or individual to make fair decisions.
Fishbone Diagram: Root cause analysis is a scheme that you have surely implemented in the laboratory. It identifies the root cause of a non-conformity. During this process, risks to impartiality may arise.
Internal audits: During your internal audits, aspects related to risks to impartiality may arise. We recommend keeping the focus on impartiality during these procedures.
Once the risk to impartiality has been identified, it must be evaluated and classified.
To evaluate it, you should assign a probability of occurrence to define its potential impact.
On the other hand, classification can be done by implementing one of the best tools, the risk matrix.
By completing this step, you will be sure to identify, classify, and evaluate the risks to impartiality in your laboratory.
Step 2: Implement Control Measures.
Once the risks to impartiality in your laboratory have been identified and evaluated, it is crucial to implement control measures so that you can mitigate them and ensure the objectivity of the results.
These control measures can include, but are not limited to, the following:
Documented Procedures: Create clear manuals detailing responsibilities, activity steps, quality controls, and data traceability. Examples include handling of samples, selection of reagents, calibration of equipment, and interpretation and reporting of results.
Training and Awareness: Educate your staff about impartiality, types of risks, control measures, and their individual responsibility. Use various strategies such as courses, workshops, and informational materials.
Declaration of Interests: Implement a system where staff declare any interests that could affect their work and impartiality. Evaluate the information and take steps to mitigate potential conflicts.
Separation of Functions: Physically or by task assignment, separate areas of the laboratory at risk of conflict of interest. Implement access controls to protect confidential information.
Internal Audits: Conduct regular reviews to evaluate the effectiveness of control measures. Look for compliance with procedures, application of controls by staff, and potential failures in the system.
Step 3: Internal and External Communication.
Effective communication is crucial to ensure that all actors involved in the clinical laboratory understand the importance of impartiality and their role in managing it.
Here are the key strategies for effective internal and external communication:
Internal Communication:
- Disseminate the impartiality policy to all staff.
- Maintain ongoing communication on the topic through meetings, newsletters, or an intranet.
- Create a secure channel for reporting impartiality risks.
External Communication:
- Publish the impartiality policy on the laboratory’s website and share it with clients and suppliers.
- Include information about impartiality management in client documentation.
- Demonstrate commitment to impartiality through certifications and external evaluation programs.
This stage within the program for ensuring impartiality is cross-sectional, indicating that you can implement it from the moment you define your policy until you carry out continuous improvement of the program.
Step 4: Monitor and evaluate.
After you have implemented control measures to protect impartiality, you must ensure the effectiveness of these measures. This will allow you to maintain a level of impartiality in your laboratory.
One way to demonstrate the effectiveness of control measures is to create a process for ongoing monitoring and evaluation.
Below, we outline the secondary steps within this stage so that you can build a process for continuous monitoring and evaluation of impartiality risks:
Definition of impartiality risk indicators.
This step aims to identify measurable indicators that allow the evaluation of the effectiveness of control measures and the level of impartiality in the laboratory.
Some strategies you can implement are:
- Risk analysis: Identify the most relevant impartiality risks for the laboratory and define indicators for each.
- Process review: Evaluate laboratory processes and determine indicators that reflect compliance with control measures.
- Data analysis: Collect and analyze data related to impartiality management, such as the number of complaints received, detection of conflicts of interest, results of internal audits, and client complaints related to impartiality.
Continuous Monitoring.
Implement a continuous monitoring system that contains the following elements:
Establishing a monitoring schedule: Define the frequency with which impartiality indicators will be measured.
Assigning responsibilities: Designate a responsible party for monitoring and data collection.
Data collection: Use appropriate tools for data collection, such as forms, records, or specialized software.
Data analysis: Periodically evaluate the collected data to identify trends or deviations.
Periodic Evaluation.
You should conduct periodic evaluations of the management program and the implemented control measures to determine their effectiveness and identify areas for improvement.
For this, we recommend the following strategies:
Planning internal audits: Schedule regular internal audits to assess compliance with the impartiality policy and control measures.
Reviewing the policy and procedures: Periodically review the impartiality policy and documented procedures to ensure their currency and adequacy.
Analyzing feedback: Collect and analyze feedback from clients, suppliers, and staff on the laboratory’s impartiality management.
Identifying areas for improvement: Based on data analysis and evaluation, identify areas where improvements can be made in the impartiality management program.
Corrective and Preventive Actions.
Implement corrective and preventive actions in case deviations or failures in the impartiality management program are detected.
Defining corrective actions: Establish a process to define and implement corrective actions in case deviations or non-conformities are detected.
Implementing preventive actions: Implement preventive actions to avoid the recurrence of deviations or failures in the impartiality management system.
Documentation and follow-up: Document the implemented corrective and preventive actions and follow up on their effectiveness.
Continuous monitoring and evaluation of the impartiality management program are essential to ensure the effectiveness of control measures and the maintenance of a high level of objectivity in the clinical laboratory.
Next, observe the last step in this impartiality management process.
Step 5: Continuous Improvement.
Maintaining impartiality over time requires a continuous process of review and update. Here are some basic items you should implement at this stage of your program to ensure impartiality:
Regularly review: Analyze whether the policy and procedures continue to be adequate for the laboratory’s context considering changes in technology, regulations, etc.
Evaluate effectiveness: Measure the performance of the impartiality management program using data, surveys, and evaluation of defined indicators.
Identify areas for improvement: Look for improvement opportunities through trend analysis, root cause investigation, and review of best practices.
Implement actions: Develop and implement concrete and measurable actions to address the identified areas.
Culture of continuous improvement: Encourage staff participation, recognition of improvement initiatives, and adaptation to change as core values of the laboratory.
A laboratory focused on continuous improvement demonstrates its commitment to quality and excellence in its results, generating trust and satisfaction among clients and stakeholders.
By implementing this guide, we assure you that you will be fully complying with the ISO 15189 standard requirements regarding the impartiality of your laboratory.
In conclusion
Impartiality is not just a regulatory requirement but a fundamental value for the clinical laboratory. By effectively implementing it, a solid foundation of trust in test results is built, which in turn translates
into:
- More informed and accurate medical decisions.
- Improved quality of patient care.
- Greater satisfaction among users and clients.
- Strengthening of the laboratory’s reputation.
- Reduction of the risk of errors and litigation.
Becoming a master of impartiality is a continuous process that requires commitment, training, and collaboration. Today, we have provided you with the tools and knowledge necessary to start this journey.
