SLIPTA Capacity Building Quiz

Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Capacity Building Quiz

INTRODUCTION

Welcome to the SLIPTA (Stepwise Laboratory Improvement Process Towards Accreditation) Capacity Building Quiz. This quiz is designed to assess your knowledge and understanding of the SLIPTA checklist requirements, which aim to guide and improve the quality and compliance of laboratory services to meet national and international standards. The questions are based on key elements from ISO 15189:2022 and the CLSI guideline QMS01-A4, which provide a framework for developing effective laboratory management systems.

The quiz covers areas essential for ensuring laboratory excellence, including point-of-care testing (POCT) and laboratory operations. Your participation will help gauge your familiarity with procedures, practices, and quality management principles that contribute to enhanced patient care and laboratory performance. This quiz is part of a broader evaluation strategy, supporting laboratories in their journey toward achieving SLIPTA star-level recognition.

Name

Country

Phone

Health Facility

Affiliated organisation

Section 1: Documents and Records 22

These questions are designed to test knowledge, understanding, and application of ISO 15189:2022’s document control and record management requirements in practical scenarios. Each question covers a different aspect of the section, ensuring comprehensive coverage of the topic.

Which of the following is the most important action when revising a standard operating procedure (SOP) in the laboratory?

Keep the SOP unchanged for consistency, as long as no major errors have been identified.

Store the old SOP along with the new one, so staff can choose which one they prefer to follow.

Update the SOP without informing staff, as they should be able to figure out the changes independently.

Re-issue the updated SOP with clear version control and ensure all affected personnel are trained on the changes.

None

2. In the context of document control, which of the following is NOT a required step when introducing a new laboratory test method?

Store all related documents in an easily accessible location for laboratory personnel.

Ensure that the new test method and its documentation are reviewed only by senior technical staff.

Ensure that all relevant staff are trained on the new method and its documentation.

Ensure that the method is validated before implementation.

None

3. What is the most effective way to ensure that laboratory records remain compliant with ISO 15189:2022 over time?

Make records available only upon specific request from auditors.

Destroy all records older than five years to prevent unnecessary storage.

Establish a document retention and disposal policy to ensure records are kept for the required duration, are regularly reviewed, and are appropriately archived.

Only keep records for as long as needed to meet accreditation requirements.

None

4. A laboratory discovers that its audit trail system for document revisions is not tracking changes made to critical records. What should be the laboratory's next step to resolve this issue?

Conduct internal audits without addressing the issue, as audit trails are not crucial for ISO 15189:2022.

Ignore the issue since the laboratory hasn’t had any major audits recently.

Implement a secure, traceable document control system that tracks all changes, including who made them, when, and the nature of the change.

Request that staff manually update records with any changes they make.

None

5. Which of the following actions is critical for ensuring the accessibility of laboratory documents in the event of an emergency?

Limit access to documents to only those with senior management positions.

Store all records in physical file cabinets and restrict digital access to minimize risk.

Ensure that key documents are stored both electronically and physically, and that all staff have access to critical records during emergencies.

Keep digital copies of records but store physical records off-site to reduce space requirements.

None

6. When it comes to record retention, which of the following is the primary reason for maintaining accurate and complete records for the required period as specified by ISO 15189:2022?

To have records available for personal reference if needed by the laboratory staff.

To ensure there is always a backup in case of staff turnover.

To maintain a historical archive for research purposes only.

To comply with legal requirements and provide documentation in case of audits or regulatory reviews.

None

7. A laboratory uses an electronic document management system (EDMS) for controlling its records. What should the laboratory do to ensure the system remains compliant with ISO 15189:2022?

Allow only management to access the EDMS to ensure security.

Allow all staff to upload and modify documents without restriction.

Use the EDMS to restrict access to records based on user roles and maintain a log of all actions, including document creation, revision, and access.

Ensure that documents are only uploaded in the EDMS after being printed for physical storage.

None

8. In an audit, it is found that some laboratory records are incomplete or improperly signed. What should the laboratory do next to ensure future compliance?

Develop and implement a corrective action plan to address record deficiencies and ensure future compliance with proper document control procedures.

Ignore the audit findings if no critical issues are involved.

Continue without any changes, as the deficiencies are minor.

Ask personnel to sign the records retroactively without further investigation.

None

Section 2: Organization and Leadership 26

These questions for Section 2: Organization and Leadership aim to challenge the user to apply their understanding of ISO 15189:2022 to real-world laboratory situations, focusing on leadership, documentation, and the management system's integrity. They are designed to not only test knowledge but also to encourage critical thinking and practical application in a laboratory setting.

A laboratory management review meeting is scheduled, and the agenda includes a discussion on resource adequacy, policy review, and corrective actions. Which of the following is a key input that should be included in the review meeting to ensure ISO 15189:2022 compliance?

The status of corrective actions from previous reviews and performance data of the laboratory activities.

Updates on staff recruitment policies and unrelated financial matters.

Discussion on the lab's social media presence.

A list of new equipment orders and their expected delivery dates.

None

2. The laboratory’s leadership is reviewing its management system and finds that no records are being kept of actions taken during management reviews. What should the laboratory do to address this issue and comply with ISO 15189:2022?

Implement a system to document all actions and decisions made during management review meetings, including responsibilities and timelines for follow-up actions.

Limit documentation to only the decisions made by senior management.

Keep the current practice since no audit or non-conformity has occurred recently.

Allow staff to implement decisions without documented accountability, as long as actions are completed.

None

3. The laboratory has a process for managing conflicts of interest among its personnel. Which of the following actions would demonstrate compliance with ISO 15189:2022 regarding conflict of interest management?

Restrict the identification of conflicts of interest to upper management and keep the process confidential without informing other staff members.

Ensure that all laboratory staff, including management, are trained in identifying conflicts of interest, and regularly review and document conflicts of interest as part of the performance management process.

Allow personnel to self-report potential conflicts of interest but take no further action unless a complaint arises.

Only address conflicts of interest in the hiring process and ignore ongoing reviews after staff have been employed.

None

4. A laboratory is planning its budget for the upcoming year. Which of the following should the laboratory consider to ensure the budget is aligned with ISO 15189:2022 requirements?

Include estimates for personnel needs, equipment, infrastructure, quality assurance, and service/maintenance, while considering the scope of testing to be performed.

Avoid forecasting for unexpected expenses, as these can be handled as they arise.

Focus solely on the cost of equipment purchases and disregard other operational costs.

Prioritize savings on operational costs, even if it reduces training and quality control activities.

None

5. A laboratory experiences an unplanned absence of its key technical personnel. What action should the laboratory take to ensure that its management system continues to function properly during this absence?

Allow the remaining staff to continue operations without any formal process, trusting their judgment.

Ask for external support but avoid documenting the deputization process.

Implement a deputization process to assign temporary responsibilities to other qualified personnel, ensuring continuity in laboratory operations and management.

Wait until the key personnel return before making any operational decisions.

None

6. The laboratory is undergoing an internal audit and the auditor notes that some management reviews have not been documented adequately. Which of the following would be the most appropriate action to address this non-conformity?

The laboratory should ensure that all management reviews are thoroughly documented, including decisions, actions, and the responsible individuals, and implement corrective actions to address the oversight.

The laboratory should consider this minor and continue with future reviews without any further action.

The laboratory should rely on verbal communication for future management reviews instead of written documentation.

The laboratory should only document management reviews when an external audit is scheduled.

None

7. When planning the laboratory’s management review meeting, which of the following is an essential aspect to be included in the review?

A discussion focused solely on upcoming purchases and budgetary allocations for new equipment.

A comprehensive evaluation of the laboratory’s quality management system, including internal audits, non-conformities, corrective actions, and resource adequacy.

A review of the laboratory’s customer feedback, staffing issues, and general office operations, but not the laboratory’s performance data.

A meeting to discuss general HR policies, without linking them to laboratory performance or quality management systems.

None

8. The laboratory has recently expanded its scope of activities and now handles additional types of tests. Which of the following would be the most important action for the laboratory leadership to take to ensure continued compliance with ISO 15189:2022?

Focus solely on training for the new tests and ignore the need for process updates and resource allocation.

Limit the scope of new tests to the existing infrastructure and reduce the testing capacity.

Allow the new tests to be integrated into the workflow without any formal review, as long as they don’t interfere with existing operations.

Review and adjust the laboratory’s management system, including resource allocation, staffing, and training, to accommodate the expanded scope of activities.

None

Section 3: Personnel Management 34

These questions for Section 3: Personnel Management test the laboratory’s ability to understand and apply ISO 15189:2022 requirements in real-world scenarios. The focus is on practical applications of personnel management processes, ensuring compliance, and fostering a culture of continuous improvement.

A laboratory is reviewing its personnel management procedures and identifies that some job descriptions have not been updated for over five years. What should the laboratory do to ensure compliance with ISO 15189:2022?

Discontinue using job descriptions altogether and rely on informal role assignments.

Only update job descriptions for senior personnel, as they are more critical to laboratory operations.

Revise the job descriptions to reflect current laboratory activities, responsibilities, and competencies required for each role, ensuring they align with ISO 15189:2022 requirements.

Continue to use the old job descriptions as they are, as they still describe the general duties of the positions.

None

2. The laboratory is assessing the competency of new staff members. Which of the following should be the laboratory's first step in ensuring compliance with ISO 15189:2022 regarding personnel competency?

Conduct competency assessments based solely on past work experience without further evaluation.

Conduct an annual review of personnel competency without considering specific tasks or responsibilities.

Define the competency requirements for each laboratory activity and ensure the assessment process is documented.

Allow new staff to begin performing laboratory tasks immediately, assuming they will learn on the job.

None

3. A laboratory has a high turnover rate among its technical staff. To address this, what should the laboratory do to comply with ISO 15189:2022 and improve personnel management?

Allow staff to work without regular supervision or performance evaluations, assuming they will improve over time.

Reduce training programs to save costs and focus only on essential staff functions.

Implement a structured orientation program for new hires, conduct regular performance reviews, and provide ongoing training and professional development opportunities.

Focus solely on hiring new staff quickly without evaluating the reasons for turnover.

None

4. The laboratory is in the process of implementing a new procedure for personnel performance reviews. Which of the following best meets the requirements of ISO 15189:2022?

Performance reviews should be conducted at regular intervals, based on defined criteria, with documented outcomes and feedback for employees.

Performance reviews should only be done if an issue with performance is identified.

Performance reviews should be conducted annually with no specific criteria or measurable outcomes

Performance reviews should be conducted informally, without any written documentation.

None

5. A laboratory is expanding its services and needs to recruit additional staff with specialized skills. According to ISO 15189:2022, what should be the laboratory’s approach to recruitment?

Define clear job profiles and descriptions, assess applicants' qualifications and skills, and ensure the recruitment process aligns with the laboratory’s specific needs.

Focus on hiring individuals from the same organization to maintain uniformity, regardless of their specific skills for the new roles.

Hire individuals without formal interviews, relying on recommendations from current staff.

Recruit personnel based solely on their qualifications, without considering their fit within the existing team.

None

6. A laboratory’s personnel training program has been in place for several years but has not been formally evaluated for effectiveness. According to ISO 15189:2022, what should the laboratory do next?

Evaluate the effectiveness of the current training program, identify gaps, and revise the training plan based on feedback and assessments of staff competency.

Discontinue training evaluations and focus only on hiring highly skilled staff.

Continue the current training program as is, since it has been in place for many years.

Focus solely on new employee training and eliminate refresher training for existing staff.

None

7. The laboratory is introducing new laboratory procedures that require specific skills and knowledge. What action should the laboratory take to ensure compliance with ISO 15189:2022 regarding personnel training?

Implement training programs but do not evaluate the effectiveness of the training.

Only provide training to senior staff and allow junior staff to learn as they go.

Provide comprehensive training, including both initial and refresher courses, and assess the staff’s competency before they begin performing the procedures independently.

Allow staff to start the new procedures without any additional training, assuming they will learn on the job.

None

8. The laboratory has a policy for personnel performance reviews, but staff members feel they are not given enough feedback. To comply with ISO 15189:2022, what should the laboratory do to improve this process?

Ensure that feedback is specific, timely, and constructive, with clear goals for improvement and development, as part of a documented performance review process.

Discontinue feedback during performance reviews to avoid confrontation.

Continue performance reviews as-is but focus only on administrative tasks rather than feedback.

Provide general feedback without specifying areas for improvement or success.

None

9. The laboratory needs to ensure that all new hires receive proper orientation to the laboratory’s policies and procedures. According to ISO 15189:2022, which of the following is most critical for an effective orientation program?

Orientation can be skipped if the new employee has prior experience in a similar laboratory.

Orientation should be a one-time event, with no follow-up.

Orientation should cover laboratory policies, safety procedures, the laboratory information system, and other critical processes, and it should include a review of relevant SOPs and performance expectations.

Orientation should focus primarily on technical skills and ignore administrative and safety policies.

None

10. A laboratory manager is tasked with ensuring that competency assessments are performed on all laboratory personnel. Which of the following actions would best comply with ISO 15189:2022?

Competency assessments should be solely based on theoretical knowledge, without considering practical skills.

Competency assessments should be done infrequently, with no documentation required.

Competency assessments should only be performed for new hires, not existing personnel.

Competency assessments should be scheduled regularly, documented, and include objective evidence such as proficiency testing or direct observation of performance.

None

Section 4: Customer Focus 24

These questions for Section 4: Customer Focus focus on ensuring that laboratory practices are aligned with ISO 15189:2022's customer service and communication standards, promoting patient and clinician satisfaction, as well as continuous improvement in service delivery.

A laboratory receives frequent complaints from patients regarding the clarity of test result reports. How should the laboratory address this issue to comply with ISO 15189:2022?

Ignore the complaints, as they are not related to laboratory performance.

Ask patients to interpret the reports themselves.

Review the format and content of test reports, involve stakeholders (including clinicians and patients) in designing clearer reports, and implement a continuous improvement process.

Focus solely on improving the technical accuracy of results, without considering the presentation of the report.

None

2. The laboratory has received feedback from clinicians that turnaround times for test results are too long. What is the first action the laboratory should take to comply with ISO 15189:2022 in response to this issue?

Analyze the laboratory's workflow and processes to identify bottlenecks, review staffing needs, and adjust processes as necessary to improve turnaround time.

Stop accepting requests from clinicians that require short turnaround times.

Continue with the current process and inform clinicians that the turnaround time is standard.

Delegate the problem to the laboratory staff without conducting a formal review.

None

3. A laboratory regularly receives inquiries from patients asking for clarification on test procedures and results. To ensure compliance with ISO 15189:2022, how should the laboratory address these requests?

Only respond to inquiries about test procedures, ignoring questions about results.

Inform patients that their questions will not be answered to maintain confidentiality.

Direct all patient inquiries to an external service provider for response.

Implement a clear and accessible communication protocol, train staff to handle inquiries professionally, and ensure that all patient requests are responded to promptly and accurately.

None

4. A laboratory has recently expanded its testing services to include more complex analyses. What must the laboratory do to ensure that it remains customer-focused in line with ISO 15189:2022?

Continuously assess customer needs and expectations regarding the new tests, and ensure that the laboratory maintains clear communication with both clinicians and patients.

Rely solely on external marketing efforts to inform customers of new services without directly engaging with them.

Focus only on the quality of the technical testing and ignore customer needs.

Reduce the scope of services to avoid complications in service delivery.

None

5. The laboratory is implementing a new patient feedback system to gather insights on its services. Which of the following actions best complies with ISO 15189:2022 requirements for customer satisfaction?

Only collect feedback from patients who are satisfied, ignoring negative responses.

Collect feedback sporadically, without a structured process for follow-up.

Collect feedback but do not analyze or use it for improvement purposes.

Collect feedback regularly, analyze it, and use the results to improve processes, addressing any issues raised by patients or clinicians.

None

6. A laboratory has implemented a new test reporting system that includes detailed, patient-friendly explanations. How should the laboratory assess whether this new system meets customer expectations according to ISO 15189:2022?

Assume the new system is effective without asking for feedback from customers.

Collect feedback from both clinicians and patients to assess the clarity and usefulness of the reports, and make adjustments as needed.

Discontinue the feedback process after the system is implemented to avoid unnecessary complications.

Focus solely on clinician feedback, as they are the primary recipients of test reports.

None

7. During a routine internal audit, it is noted that laboratory staff are not effectively communicating test result delays to patients or clinicians. What should the laboratory do to ensure customer focus and comply with ISO 15189:2022?

Ignore the communication issue, as it has not caused major problems.

Delay communication until the results are final, even if this creates uncertainty for patients and clinicians.

Implement a formal procedure for notifying customers of test delays, ensuring timely communication, and resolving any concerns.

Only inform patients of delays after they inquire about their test results.

None

8. A laboratory is considering offering a new test that is highly requested by clinicians. What is the best course of action to ensure customer needs are met while complying with ISO 15189:2022?

Introduce the new test immediately without evaluating its feasibility or impact on service delivery.

Assess the laboratory’s capacity to perform the new test, consult with clinicians to understand their needs, and develop a plan for implementation that includes staff training and quality control.

Only introduce the new test if it can be performed quickly, without considering other aspects such as quality or customer need.

Delay the introduction of the new test indefinitely to avoid disruption to current operations.

None

9. A laboratory receives frequent requests for urgent testing from clinicians. To better meet customer expectations and comply with ISO 15189:2022, what should the laboratory do?

Ignore the requests and inform clinicians that all tests will be processed in the same order regardless of urgency.

Only handle urgent requests for certain types of tests.

Refuse all urgent test requests to maintain a standard process.

Establish a clear protocol for handling urgent test requests, ensuring prompt action while maintaining quality and safety standards.

None

10. A laboratory is implementing a new laboratory information management system (LIMS) to streamline test result reporting. What should the laboratory prioritize to ensure compliance with ISO 15189:2022?

Ensure the system is user-friendly for all stakeholders, provides clear and accurate reporting, and allows for prompt delivery of results to clinicians and patients.

Prioritize data storage capacity over system usability.

Implement the system without any training for staff or users.

Focus only on the technical aspects of the system without considering user needs.

None

Section 5: Equipment Management 44

These questions for Section 5: Equipment Management focus on the importance of effective equipment management practices, including calibration, preventive maintenance, and proper documentation, to ensure compliance with ISO 15189:2022 standards and maintain the reliability and accuracy of laboratory operations.

A laboratory has recently acquired new testing equipment that requires regular calibration. According to ISO 15189:2022, what should the laboratory do to ensure proper management of the equipment?

Rely on the manufacturer’s calibration service without documenting the process.

Develop a calibration schedule, ensure that personnel are trained, and keep records of calibration and maintenance activities.

Calibrate the equipment only during internal audits.

Perform calibration only when the equipment starts showing errors in test results.

None

2. The laboratory is experiencing occasional equipment malfunctions that lead to test result delays. Which of the following steps would best comply with ISO 15189:2022 to address this issue?

Wait for the equipment to break down completely before calling for repairs.

Perform a root cause analysis to determine the source of the malfunction, establish a preventive maintenance program, and ensure regular inspections and testing.

Purchase new equipment and discard the old equipment without further evaluation.

Only repair the equipment when complaints from patients or clinicians arise.

None

3. The laboratory uses both automated and manual equipment for testing. How should the laboratory ensure the continued performance of both types of equipment, as per ISO 15189:2022?

Allow manual equipment to be used as a backup in case of automated equipment failure without any maintenance.

Implement maintenance and calibration procedures for both automated and manual equipment, ensuring they meet defined specifications and are validated regularly.

Focus on maintaining only the automated equipment, as it is more advanced.

Only monitor the manual equipment when it is used in routine testing.

None

4. The laboratory recently introduced a new piece of equipment that is crucial for performing a specific test. What should the laboratory do to ensure that the equipment is properly integrated into its quality management system?

Ensure the equipment undergoes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) procedures, followed by training personnel and documenting the process.

Begin using the equipment immediately without any validation process as long as the test is simple.

Rely solely on the vendor for testing and validation of the equipment’s performance.

Use the equipment without any further validation if the manufacturer guarantees its accuracy.

None

5. In a laboratory where multiple pieces of critical equipment are used, how should the laboratory prioritize equipment maintenance and repair to meet ISO 15189:2022 standards?

Perform maintenance based on a first-come, first-served basis without considering the equipment’s criticality.

Only maintain equipment when it breaks down.

Delegate equipment maintenance to external contractors with no clear schedule or responsibility within the laboratory.

Implement a risk-based approach to prioritize maintenance for critical equipment that directly impacts patient safety or test results.

None

6. A laboratory receives a new piece of equipment from the manufacturer. Before putting it into use, what is the first step the laboratory should take to ensure compliance with ISO 15189:2022?

Start using the equipment without any checks, assuming it is in working order.

Request the manufacturer’s warranty and ignore any further validation requirements.

Perform an installation and operational check, including ensuring the equipment meets specifications and is properly calibrated.

Put the equipment into service immediately to avoid delays.

None

7. The laboratory's equipment is regularly serviced and maintained. However, there is no clear record of service history. What action should the laboratory take to comply with ISO 15189:2022?

Rely on verbal confirmation from maintenance personnel to confirm service and calibration.

Record only the most recent service and ignore older records.

Establish a system to record all maintenance, service, and calibration activities for each piece of equipment, ensuring traceability and compliance with ISO 15189:2022.

Continue operations without records, assuming that maintenance is being done properly.

None

8. An equipment malfunction caused a series of inaccurate test results. How should the laboratory respond to comply with ISO 15189:2022 in managing this nonconformance?

Only investigate if a complaint is received from a patient or clinician.

Investigate the root cause of the malfunction, assess its impact on patient safety and test accuracy, and take corrective actions, including reviewing all affected test results.

Continue using the equipment without further investigation, as it is working now.

Discard the faulty results without investigation.

None

9. The laboratory has a policy to replace equipment only when it is no longer repairable. What would be the most appropriate action to take to meet the preventive maintenance and equipment management requirements of ISO 15189:2022?

Continue repairing equipment indefinitely, even if it frequently malfunctions.

Establish a proactive preventive maintenance schedule that includes regular reviews of equipment performance and timely replacement or upgrade of aging equipment.

Replace equipment randomly without a proper assessment of need.

Ignore preventive maintenance and replace equipment only when it completely fails.

None

10. A laboratory has recently implemented a preventive maintenance program for its equipment. What key element should be included in the program to ensure it aligns with ISO 15189:2022?

Perform preventive maintenance only when equipment fails to operate.

Document maintenance only if the equipment breaks down.

Perform maintenance on an ad-hoc basis, depending on equipment usage.

Ensure that maintenance activities are planned, documented, and traceable, and that they are based on the manufacturer’s guidelines and the laboratory’s operational needs.

None

Section 6: Assessment 24

These questions for Section 6: Assessment cover various aspects of the laboratory’s assessment processes, including internal audits, corrective actions, proficiency testing, and performance evaluations. They test the laboratory’s

A laboratory has implemented an internal audit program to assess compliance with its quality management system. Which of the following is the best approach to ensure it meets the requirements of ISO 15189:2022?

Internal audits should be conducted only when major issues are identified.

Only the laboratory director should perform internal audits to maintain consistency.

Internal audits should be conducted by external consultants to ensure objectivity.

Internal audits should be scheduled at regular intervals, cover all relevant areas, and include an evaluation of the effectiveness of the laboratory’s quality management system.

None

2. The laboratory has recently conducted an internal audit and identified several nonconformities. According to ISO 15189:2022, what should the laboratory do next?

Postpone corrective actions until the next scheduled management review meeting.

Only document the nonconformities but take no immediate action.

Document the nonconformities, evaluate their impact, and implement corrective actions, followed by a re-audit to confirm the corrective actions were effective.

Ignore the nonconformities as they are minor and don’t affect the quality of results.

None

3. The laboratory uses external quality assurance (EQA) programs to assess its testing performance. Which of the following actions would best ensure compliance with ISO 15189:2022?

Participate in EQA programs occasionally, depending on the laboratory’s workload.

Rely only on internal quality control (IQC) programs and avoid participation in external assessments.

Consistently participate in appropriate EQA programs, evaluate the results, and take corrective actions for any discrepancies identified.

Use EQA results only when requested by external regulators or accrediting bodies.

None

4. The laboratory has implemented a system for monitoring and measuring its performance. Which of the following would be the best method to assess the effectiveness of this system, in line with ISO 15189:2022?

Use regular performance reviews and audits, as well as feedback from internal and external sources, to assess the system's effectiveness and identify areas for improvement.

Review performance metrics only when there is a complaint from a customer or stakeholder.

Focus only on patient feedback as a measure of system effectiveness.

Only review performance data annually to save time and resources.

None

5. During an internal audit, a laboratory identifies a significant deviation from standard operating procedures (SOPs). What action should the laboratory take in accordance with ISO 15189:2022?

Ignore the deviation if it doesn’t affect the immediate test results.

Do nothing, as SOP deviations are common in laboratories.

Document the deviation, assess its impact, and take corrective actions to prevent recurrence.

Inform the external accreditation body without implementing corrective actions.

None

6. The laboratory has an established procedure for corrective actions in response to nonconformities. What is the most important element that should be included in the procedure to meet ISO 15189:2022 requirements?

Corrective actions should only focus on addressing the immediate symptoms rather than the root cause.

Corrective actions should be taken only when a major issue is identified.

Corrective actions should be documented, investigated, analyzed for root cause, and implemented in a timely manner to prevent recurrence.

Corrective actions should be left to individual personnel discretion without any formal procedure.

None

7. The laboratory has participated in an external proficiency testing program but did not meet the required performance criteria. According to ISO 15189:2022, what should the laboratory do next?

Disregard the result as it doesn’t reflect the laboratory’s typical performance.

Blame external factors such as sample quality or testing conditions.

Investigate the causes of failure, take corrective actions to address any identified issues, and document the actions taken.

Wait for the next proficiency test to see if the issue resolves on its own.

None

8. The laboratory has developed a quality management system (QMS) and has established assessment methods. How should the laboratory ensure the effectiveness of its QMS, in line with ISO 15189:2022?

Regularly review the QMS, based on internal audits, external audits, proficiency tests, and performance evaluations, and make improvements where necessary.

Rely on the QMS without reviewing its effectiveness, assuming it is working as intended.

Focus solely on external audits and avoid internal assessments.

Review the QMS only when there is a major issue or failure in testing.

None

9. During a routine review of the laboratory’s performance metrics, the laboratory identifies an area where performance consistently falls short of its established standards. According to ISO 15189:2022, what should the laboratory do next?

Investigate the root cause of the issue, implement corrective actions, and monitor the effectiveness of these actions.

Increase the frequency of testing without addressing the underlying issue.

Accept the lower performance as a normal variation and take no action.

Ignore the issue, as performance may improve on its own over time.

None

10. The laboratory regularly assesses its processes and systems through audits and performance evaluations. What key factor is essential for the success of the laboratory’s assessment processes, according to ISO 15189:2022?

Audits should only be conducted by the laboratory director.

Objectivity, thoroughness, and follow-up actions are essential to ensure meaningful assessments that drive improvements.

External audits are the only necessary assessment process.

Assessments should be limited to equipment performance alone.

None

Section 7: Supplier and Inventory Management 27

These questions for Section 7: Supplier and Inventory Management cover key aspects of supplier selection, monitoring, and inventory management, testing the laboratory's ability to ensure the consistent quality and availability of materials through effective supplier and inventory management systems.

The laboratory is considering a new supplier for reagents. According to ISO 15189:2022, which of the following actions is most critical when selecting a new supplier?

Assessing the supplier’s ability to meet specified requirements, including product quality, delivery performance, and regulatory compliance.

Selecting the supplier based on the lowest price to reduce costs.

Choosing the supplier with the largest market share, regardless of product quality.

Relying solely on the supplier’s reputation without performing an independent assessment.

None

2. The laboratory uses a specific reagent from a supplier that has been delivering goods consistently over the past year. However, there has been a recent issue with a batch of reagents. What should the laboratory do first, according to ISO 15189:2022?

Discard the batch without reporting it to the supplier.

Immediately inform the supplier about the issue, document the nonconformity, and initiate corrective actions.

Continue using the reagent as there is no immediate risk to test results.

Wait for the next batch and see if the problem persists.

None

3. A laboratory receives a shipment of laboratory supplies from a new vendor. What is the most important initial step that the laboratory should take to comply with ISO 15189:2022?

Start using the supplies immediately without checking the shipment.

Perform testing on a sample from the shipment, but do not verify supplier documentation.

Verify that the supplies meet the specifications outlined in the supplier agreement, including quality control and documentation.

Only check the price of the supplies to ensure they align with budget constraints.

None

4. The laboratory is experiencing a delay in the delivery of critical supplies from its primary supplier. What is the most appropriate course of action according to ISO 15189:2022?

Accept the delay and wait for the next delivery without action.

Continue operations without informing the supplier.

Notify the supplier of the delay, assess the impact on laboratory operations, and evaluate alternative suppliers or contingency measures.

Cancel the supplier’s contract immediately without assessing the cause of the delay.

None

5. A laboratory has established a system for monitoring the performance of suppliers. Which of the following best describes how the laboratory should assess supplier performance according to ISO 15189:2022?

Rely only on the supplier’s self-reported performance metrics.

Only assess the supplier’s performance when there are problems with the products.

Conduct regular performance evaluations based on factors such as product quality, delivery reliability, and compliance with agreed-upon standards.

Focus solely on the financial performance of the supplier, without considering product quality.

None

6. The laboratory is considering switching to a new supplier for laboratory reagents. What is the first step the laboratory should take according to ISO 15189:2022?

Start purchasing reagents from the new supplier without evaluating their performance.

Choose the new supplier based on price alone, as long as the reagents are available.

Ask the supplier to send a sample batch for testing, but do not assess the supplier’s overall capabilities.

Conduct a thorough assessment of the new supplier’s capabilities, including their quality management system, regulatory compliance, and ability to meet the laboratory’s requirements.

None

7. The laboratory’s inventory management system is regularly updated with details about all purchased items. According to ISO 15189:2022, which of the following best describes how inventory should be managed?

The laboratory should track inventory levels, expiry dates, usage frequency, and any necessary re-ordering processes to ensure timely availability of critical materials.

The laboratory should store all materials without any inventory system as long as there are no shortages.

The laboratory should only monitor inventory levels and not track expiry dates or usage frequency.

The laboratory should maintain an inventory only for high-cost items, and ignore inventory management for other materials.

None

8. When a supplier fails to deliver critical reagents on time, the laboratory’s contingency plan involves sourcing the reagents from a secondary supplier. How should the laboratory ensure that this contingency is in line with ISO 15189:2022?

The laboratory should switch to the secondary supplier immediately without evaluating the supplier's performance.

The laboratory should continue without the reagents until the primary supplier delivers, even if it affects testing operations.

The laboratory should rely on emergency orders with expedited delivery and wait for a resolution from the original supplier.

The laboratory should have already identified and evaluated alternative suppliers before the need for a contingency plan arises and ensure these suppliers meet the same quality standards.

None

9. The laboratory is planning a long-term relationship with a reagent supplier. What action is necessary to ensure the ongoing compliance of the supplier with ISO 15189:2022?

Assume the supplier will always comply with the terms of the contract.

Establish a system for ongoing monitoring of the supplier’s performance and compliance, including periodic audits and assessments.

Rely solely on the supplier’s self-assessment and ignore regular evaluations.

Discontinue evaluations after the first successful audit.

None

10. The laboratory needs to ensure that the suppliers of its critical reagents are compliant with international regulatory standards. What action should the laboratory take according to ISO 15189:2022?

Only check compliance if there is a complaint about the reagents.

Rely only on the supplier’s statements of compliance.

Verify the supplier’s compliance with applicable regulatory standards, such as ISO certification or regulatory body approvals, before placing orders.

Wait until a regulatory body audits the supplier before verifying compliance.

None

Section 8: Process Management 71

These questions are designed to challenge the laboratory's understanding and implementation of process management according to ISO 15189:2022, testing their ability to apply knowledge in practical scenarios.

The laboratory has identified several processes essential for delivering accurate test results. Which of the following best describes how the laboratory should manage these processes according to ISO 15189:2022?

Processes should be left to the discretion of the personnel performing them without oversight.

Processes should only be reviewed when complaints or errors occur.

There is no need to review processes once they are initially set up, as they are assumed to be effective.

All processes should be documented, standardized, and regularly reviewed to ensure they are effective and aligned with the laboratory’s objectives.

None

2. The laboratory is introducing a new test procedure for a routine diagnostic test. What should the laboratory do to ensure the process meets the requirements of ISO 15189:2022?

Implement the procedure immediately without any validation or training.

Develop the procedure, validate it to confirm its effectiveness, train relevant personnel, and monitor the process for compliance and performance.

Rely on the manufacturer’s instructions without assessing the new process for specific laboratory needs.

Assume the process is automatically compliant with ISO 15189 once the procedure is developed.

None

3. A laboratory is considering the introduction of a new automated system to streamline its test reporting. How should this change be managed to comply with ISO 15189:2022?

Assess the system's ability to meet the laboratory’s needs, validate its performance, train staff on its use, and integrate it with existing processes.

Introduce the system without additional steps, as automation will improve efficiency automatically.

Introduce the system as a trial without validation, and adjust as needed.

Skip system validation and rely on the manufacturer’s demonstration of system performance.

None

4. The laboratory’s processes for handling patient specimens need to be optimized for better efficiency. According to ISO 15189:2022, what should the laboratory do to improve these processes?

Modify processes only when there is a significant complaint or incident.

Implement changes based on external recommendations without internal evaluations.

Regularly assess the processes for inefficiencies, identify opportunities for improvement, and implement changes where necessary to enhance patient care and operational efficiency.

Keep the current processes without change, as they have been working fine for years.

None

5. When reviewing laboratory processes, it is important to address any inefficiencies or bottlenecks that may arise. What should the laboratory do to ensure that the improvements are sustainable and effective in the long term?

Implement short-term fixes and assume the problem will not recur.

Focus solely on eliminating costs rather than optimizing overall process efficiency.

Make changes and assume that they will automatically solve the problem without further follow-up.

Ensure any process improvements are thoroughly documented, followed up by staff training, and continuously monitored for long-term effectiveness.

None

6. The laboratory is working on process validation for a newly implemented analytical test. According to ISO 15189:2022, which of the following should be part of the validation process?

The laboratory should confirm that the test meets the required accuracy, precision, and reproducibility under laboratory conditions, and document the validation results.

The laboratory can skip validation if the test is already used in other accredited laboratories.

The laboratory should validate only the equipment used, not the entire test process.

The laboratory should assume the new test method is validated based on the manufacturer's data.

None

7. The laboratory has decided to introduce a process improvement initiative targeting the reduction of turnaround time for test results. Which of the following strategies is most aligned with ISO 15189:2022 requirements for process management?

Make changes based on assumptions without data collection or performance monitoring.

Introduce the initiative without any baseline measurement of current performance.

Measure the current turnaround time, identify specific bottlenecks, implement improvements, and monitor the results to ensure that the improvements lead to consistent reductions in turnaround time.

Focus on reducing turnaround time without considering the impact on accuracy or quality.

None

8. During the process design phase, the laboratory needs to ensure that all steps are in compliance with ISO 15189:2022. Which of the following factors should be included in process design and optimization?

Only focus on the technical aspects of the process, excluding personnel training and operational issues.

Ensure the process design is efficient, compliant with regulatory requirements, includes effective quality control measures, and is regularly evaluated for improvements.

Rely only on external audits to ensure the process is compliant with ISO 15189:2022.

Design processes without considering the training needs of staff.

None

9. The laboratory is dealing with a recurring issue of delays in reporting due to workflow inefficiencies. How should the laboratory address this in line with ISO 15189:2022?

Increase the workload of existing staff without changing processes.

Identify the root causes of the delays, modify the workflow processes accordingly, and monitor for improvements over time.

Outsource the reporting function to a third party without assessing internal workflow processes.

Ignore the inefficiencies and continue operating as usual.

None

10. The laboratory wants to ensure that changes to its processes are properly controlled to maintain compliance with ISO 15189:2022. Which of the following should the laboratory do before implementing changes?

Evaluate the potential impact of the changes on the overall system, seek approval from relevant stakeholders, document the changes, and train staff as needed.

Ignore the need for evaluation and make changes only when external audits require them.

Focus on cost-cutting changes without considering process stability.

Implement changes immediately without prior approval.

None

Section 9: Information Management 24

These questions for Section 9: Information Management are designed to challenge the user to think critically about the integration of technology, data security, and proper information management in the laboratory, all within the framework of ISO 15189:2022. They test both technical knowledge and practical application of the standard's principles in real-world laboratory operations.

A laboratory’s information management system (LIMS) has recently experienced several software glitches, affecting data accuracy. Which of the following actions is most appropriate for the laboratory to ensure compliance with ISO 15189:2022?

Ask staff to rely on paper records until the software glitches are resolved.

Discontinue using the LIMS until the software glitches are fixed, but do not review the root cause of the problem.

Conduct a risk assessment of the software glitches, take immediate corrective actions, and review the effectiveness of the corrective actions.

Continue to use the system and manually correct errors without informing the staff about the issues.

None

2. The laboratory is reviewing its electronic patient data management process. According to ISO 15189:2022, which of the following is critical to ensure the confidentiality and security of patient data?

Access to patient data should be restricted based on the role of the personnel, with appropriate authorization and audit trails.

Regular backups of patient data without encryption.

Patient data should be available to all laboratory personnel without restrictions to ensure smooth operations.

Patient data should be stored indefinitely without any access restrictions.

None

3. A laboratory receives a request for laboratory results via email. The laboratory's information management system does not have secure transmission protocols in place. What should the laboratory do to ensure compliance with ISO 15189:2022?

Implement secure transmission protocols, such as encryption, for transmitting patient data, and inform clients of the secure channels available.

Proceed with sending the results through email, as there is no mention of secure communication in the standard.

Continue sending results without any changes, but stop emailing sensitive patient information.

Inform the client that email is not a secure method and request that they pick up the results in person.

None

4. A laboratory has decided to migrate its data storage system to the cloud. Which of the following actions should the laboratory take to comply with ISO 15189:2022 for information management?

Ensure that the cloud provider complies with relevant data protection laws, ensures data integrity, and provides secure access controls.

Limit the cloud storage to non-sensitive information only, ignoring compliance requirements for sensitive patient data.

Migrate the data immediately without verifying the cloud provider’s security and compliance measures.

Use the cloud service provider's default settings without reviewing them for compliance with ISO 15189:2022.

None

5. The laboratory needs to ensure that laboratory data is traceable and retrievable when required. What action should the laboratory take to meet ISO 15189:2022 requirements for information management?

Print and store hard copies of all laboratory data as a backup, ignoring electronic storage systems.

Allow all staff access to all laboratory data to avoid bottlenecks in accessing results.

Retain data in a secure database with regular backups and ensure that access is logged and auditable.

Only store data for one year, as per the laboratory’s own policy, regardless of clinical or regulatory requirements.

None

6. The laboratory is introducing a new laboratory information management system (LIMS). Before full implementation, the laboratory should:

Implement the system immediately for all users without any prior testing or validation.

Allow users to explore the system without formal training or validation to identify issues organically.

Test the system with a small set of data to ensure compatibility with existing processes and validate the system’s performance.

Only review the new system’s functionality and ignore data migration and security aspects.

None

7. The laboratory's information management policy outlines that all data modifications must be traceable. Which of the following is the best method to ensure compliance with this requirement?

Only record changes made by senior personnel in the system.

Allow any modification to be made by the laboratory staff without any further review or approval process.

Allow modifications to be made to the data without recording who made the changes.

Ensure that the laboratory’s information management system includes audit trails that record all changes, including the user who made the modification and the reason for the change.

None

8. The laboratory is updating its records management system. What should the laboratory consider to ensure compliance with ISO 15189:2022 during the update?

Ensure the updated system complies with legal and regulatory requirements for record retention, data security, and accessibility, while allowing flexibility for future system updates.

Update the system to handle only electronic records and discard paper records entirely.

Make no changes to the system but continue to use it as is, even though it’s outdated.

Limit the update to adding more storage capacity, without considering data security and access controls.

None

9. A laboratory is facing an issue with miscommunication of results due to manual transcription errors. What should the laboratory do to improve information accuracy and compliance with ISO 15189:2022?

Ignore the errors and assume they do not significantly impact the overall laboratory performance.

Allow manual transcription without any changes, as this is a common issue in laboratories.

Implement an electronic data entry system to reduce the risk of human error and improve accuracy in reporting results.

Continue with manual transcription but add a second layer of review to detect errors.

None

10. The laboratory is planning to transition to a fully digital system for all patient and test records. Which of the following actions should the laboratory prioritize to ensure compliance with ISO 15189:2022 during the transition?

Perform a thorough validation of the new digital system, including data migration, backup, security, and access control, while ensuring that no data is lost during the transition.

Allow the new system to run alongside the old system for a year before making any decisions.

Immediately stop maintaining any paper records and only rely on digital records.

Make the transition without consulting any IT specialists to save costs.

None

Section 10: Nonconforming Events 13

These questions address key aspects of managing nonconforming events in the laboratory environment, in compliance with ISO 15189:2022. They challenge the laboratory’s ability to identify, investigate, document, and take appropriate actions for nonconformities, ensuring quality and reliability in laboratory operations.

A laboratory receives a complaint from a client about incorrect test results. According to ISO 15189:2022, what is the first step the laboratory should take to address this nonconforming event?

Notify the client that the results are final and cannot be changed.

Ignore the complaint if the results are not critical.

Report the complaint to regulatory authorities without investigating internally.

Investigate the complaint immediately to determine if it is valid and identify the root cause of the nonconformance.

None

2. During an internal audit, a laboratory discovers that a particular test procedure has not been followed correctly on several occasions. How should the laboratory address this nonconformance according to ISO 15189:2022?

Blame the personnel involved and take no further action.

Review the procedure, identify the root cause of the nonconformance, take corrective action to prevent recurrence, and document the findings and actions taken.

Ignore the issue and continue with the current procedure.

Discard the nonconforming results without any further action.

None

3. A laboratory discovers a batch of test results is inaccurate due to a calibration error in the equipment. Which of the following should the laboratory do according to ISO 15189:2022?

Correct the error but do not inform the clients or document the issue.

Dispose of the entire batch without investigating.

Document the nonconformance, notify relevant stakeholders, investigate the calibration error, and implement corrective and preventive actions.

Ignore the inaccurate results if they are from a previous testing batch.

None

4. When a nonconforming event is identified, it is crucial for the laboratory to determine whether any previous results may have been affected. What does ISO 15189:2022 recommend the laboratory do in this case?

Only review the most recent tests, as earlier results are irrelevant.

Assume that only the current batch is affected and take no further steps.

Review all affected tests to determine the extent of the impact and assess if corrective actions are necessary.

Rely on the manufacturer's guidance to determine if any past results were affected.

None

5. A laboratory receives a nonconformance report from a referral laboratory regarding a sample it sent for further testing. According to ISO 15189:2022, how should the laboratory handle this?

Investigate the cause of the nonconformance, communicate with the referral laboratory to determine the issue, and take corrective actions to prevent recurrence.

Ignore the referral laboratory's feedback, as they are an external entity.

Assume that the nonconformance was due to errors in the referral laboratory's processes.

Ignore the report if it doesn't affect the laboratory's direct activities.

None

6. Following the identification of a nonconformance, the laboratory is required to implement corrective actions. Which of the following is the primary goal of corrective actions, according to ISO 15189:2022?

To discipline the staff involved in the nonconformance.

To avoid discussing the nonconformance with other laboratories or stakeholders.

To minimize the reporting of nonconformities in the future.

To identify and eliminate the root cause of the nonconformance and prevent its recurrence.

None

7. After implementing corrective actions for a nonconformance, the laboratory should verify the effectiveness of these actions. Which of the following is the best way to verify the effectiveness, according to ISO 15189:2022?

Rely on the personal judgment of the laboratory director without formal follow-up.

Review the process after some time, monitor for recurrence of the issue, and assess the overall impact of the corrective actions.

Assume the issue has been resolved and stop monitoring.

Document the corrective actions without any follow-up or verification.

None

8. A laboratory receives a nonconforming sample that affects the accuracy of a test result. According to ISO 15189:2022, what should the laboratory do next?

Report the test results without modification, assuming the sample will not affect the result.

Proceed with testing and ignore the nonconforming sample.

Contact the customer and ask them to resend the sample without documenting the nonconformance.

Reject the nonconforming sample, document the issue, and take corrective actions to prevent similar issues in the future.

None

9. When an event occurs that leads to noncompliance with ISO 15189:2022 requirements, how should the laboratory document the corrective actions taken?

Do not document the corrective actions if the issue is resolved internally.

Only record the actions taken without noting the root cause.

Only document the corrective actions if the issue affects external stakeholders.

Document the root cause, corrective actions, and the outcome of the corrective action process, including verification that the issue is resolved.

None

10. What should the laboratory do if a nonconforming event affects the validity of previously reported results?

Assume the nonconformance has no impact on previous results if they were issued correctly at the time.

Only notify clients for results within the last week.

Review the previous results, determine if they were impacted, and take corrective actions, including notifying clients if necessary.

Ignore the issue and continue reporting results as normal.

None

Section 11: Continual Improvement 07

These questions assess the laboratory’s commitment to continual improvement as required by ISO 15189:2022, testing both its proactive and reactive approaches to enhancing quality and performance in laboratory operations.

A laboratory has implemented several changes in its processes over the past year. According to ISO 15189:2022, what is the primary objective of evaluating these changes?

To decide whether more changes are necessary.

To make sure that laboratory staff follow the new procedures without question.

To determine if they were cost-effective.

To assess their effectiveness in improving quality and meeting customer requirements.

None

2. The laboratory is planning to introduce new software for its laboratory information management system (LIMS). According to ISO 15189:2022, which of the following is a key consideration in ensuring continual improvement during the software implementation process?

Avoiding any changes to the current system and introducing the new system without additional training.

Ensuring that only senior management is involved in the decision-making process.

Focusing on the cost and speed of implementation rather than the quality of the software.

Identifying and addressing potential risks, and training staff to effectively use the new system.

None

3. A laboratory has identified a problem with its patient result turnaround times. To improve performance, the laboratory implements new workflows. Which of the following best demonstrates continual improvement, according to ISO 15189:2022?

The laboratory only monitors patient results for the next month and stops once it sees an improvement.

The laboratory assumes the issue will resolve on its own and does not monitor the new workflow's impact.

The laboratory completely discards the old workflows without evaluating their effectiveness.

The laboratory implements new workflows, monitors their effectiveness, and makes further adjustments if necessary.

None

4. When planning for continual improvement, how should a laboratory handle feedback from staff regarding laboratory processes and quality issues?

Act on all feedback immediately, even without considering the broader context.

Gather and review feedback regularly, then act on it to improve processes, systems, and quality outcomes.

Only address feedback that is related to immediate concerns, disregarding long-term suggestions.

Ignore feedback unless it comes from senior staff.

None

5. A laboratory is assessing its performance in managing patient samples. The laboratory recently introduced new quality control measures, but staff are unsure if they are effective. What should the laboratory do next according to ISO 15189:2022?

Perform a periodic evaluation of the new quality control measures and review the outcomes to determine if further improvement is needed.

Assume the new measures are working, without conducting any evaluation.

Only evaluate the quality control measures once a year.

Do nothing since quality control is usually effective on its own.

None

6. To foster a culture of continual improvement, the laboratory encourages all employees to contribute ideas for process enhancements. What is a key action the laboratory should take to ensure that this feedback leads to effective improvements?

Collect feedback but take no action unless there is a serious problem.

Disregard feedback that does not directly relate to the laboratory’s daily operations.

Collect and analyze all feedback, act on it where appropriate, and communicate outcomes and improvements to all staff members.

Only consider feedback from senior staff to maintain authority.

None

7. A laboratory notices that its internal audit findings are not always being acted upon by relevant staff. To ensure continual improvement, what should the laboratory do according to ISO 15189:2022?

Ensure that audit findings are communicated clearly to responsible personnel and that corrective actions are tracked to completion.

Only act on audit findings if they are raised by senior management.

Ignore the findings and focus only on future audits.

Stop conducting internal audits as they seem ineffective.

None

8. The laboratory is working on a project to reduce specimen rejection rates. After introducing new measures, how can the laboratory evaluate whether the process has improved, in line with ISO 15189:2022?

By waiting for the next audit to assess whether improvements have been made.

By reviewing data on specimen rejection rates before and after the changes, and conducting follow-up assessments.

By assuming that the process has improved if there are fewer complaints.

By relying solely on staff feedback without examining the data.

None

9. A laboratory's management reviews its quality performance annually. To meet the continual improvement requirement of ISO 15189:2022, how should the laboratory proceed during this review?

Skip the review if the laboratory is currently running smoothly.

Evaluate the effectiveness of current processes, identify areas for improvement, and ensure actions are taken to address any issues.

Only review the performance of senior staff and ignore broader system performance.

Focus only on areas where external audits have pointed out problems.

None

10. After implementing a series of improvements, the laboratory realizes that there is an unanticipated consequence that negatively impacts another area of service. According to ISO 15189:2022, what should the laboratory do?

Continue with the new processes regardless of the negative consequences.

Immediately undo the improvements without further investigation.

Ignore the issue, assuming the improvements are good overall.

Investigate the unintended consequence, assess its impact, and take corrective actions to address the negative outcome while maintaining improvements elsewhere.

None

Section 12: Facilities and Safety 57

These questions assess the laboratory's understanding of facilities management and safety practices, ensuring that the laboratory complies with ISO 15189:2022 standards for a safe, efficient, and compliant working environment.

A laboratory is planning to expand its space for processing samples. In accordance with ISO 15189:2022, which of the following should the laboratory prioritize when planning the new space?

Hiring contractors based only on the lowest bid.

Focusing solely on aesthetics and appearance to make the laboratory more appealing.

Reducing costs by using the same equipment and layout as the existing laboratory.

Ensuring the space meets specific requirements for workflow, safety, and containment, and that it complies with relevant regulatory requirements.

None

2. To comply with ISO 15189:2022, what should a laboratory do to ensure the safety of laboratory personnel working with hazardous chemicals?

Only provide personal protective equipment (PPE) to senior laboratory staff.

Ensure that laboratory staff are trained in the use of safety equipment, chemicals are stored properly, and that safety procedures are regularly reviewed and updated.

Provide only basic safety equipment and rely on personnel to use their judgment.

Rely on the external safety auditors to ensure safe practices are followed.

None

3. A laboratory has been experiencing frequent power outages that affect testing procedures. To align with ISO 15189:2022, which of the following should be implemented to mitigate this risk?

Ensure all testing procedures continue as usual, despite the interruptions.

Implement backup power systems, such as generators, and develop contingency plans for emergencies to ensure continued service delivery.

Wait until the issue is raised by external inspectors before taking action.

Avoid informing staff about the power issues to prevent panic.

None

4. The laboratory is considering improving its environmental conditions, including ventilation and temperature control. According to ISO 15189:2022, what is the most important aspect to consider?

The environmental improvements should only focus on the appearance of the laboratory.

The improvements should ensure that the laboratory environment is suitable for the processes and ensures the accuracy of test results while maintaining personnel safety.

Environmental changes should be made without consulting laboratory staff.

The improvements should only apply to administrative offices and not the laboratory areas where tests are performed.

None

5. In the laboratory, regular maintenance of safety equipment is a key part of compliance with ISO 15189:2022. How often should safety equipment, such as fire extinguishers and emergency eyewash stations, be checked?

Every five years, as long as there are no obvious signs of damage.

At least annually and after each use, or as required by the manufacturer's guidelines.

Once every two years.

Only when an emergency occurs.

None

6. A laboratory’s safety officer is responsible for ensuring compliance with safety protocols. Which of the following is a primary responsibility of the safety officer, according to ISO 15189:2022?

Ensuring the laboratory has the necessary insurance coverage for accidents.

Managing financial budgets for the laboratory.

Overseeing the implementation and regular review of safety procedures to mitigate risks.

Creating policies for maintaining laboratory equipment.

None

7. A laboratory is conducting a risk assessment to identify potential safety hazards. Which of the following best demonstrates compliance with ISO 15189:2022 in performing this risk assessment?

The laboratory involves personnel from all levels, assesses all potential hazards, and implements corrective actions to address identified risks.

The laboratory performs the risk assessment only after an accident occurs.

The laboratory only considers hazards related to equipment failures.

The laboratory focuses only on physical hazards and ignores potential chemical or biological hazards.

None

8. What action should a laboratory take to ensure compliance with ISO 15189:2022 concerning the safety of laboratory personnel working with biological materials?

Conduct regular training on handling biological materials, ensure proper containment, and ensure that staff are fully aware of emergency procedures.

Rely solely on external regulatory bodies to provide the necessary training.

Avoid discussing potential risks with laboratory staff to maintain confidence.

Provide PPE only for new staff and assume that the risks are managed automatically.

None

9. A laboratory is designing a new laboratory section that requires both physical containment and an ergonomic work environment. What should the laboratory prioritize according to ISO 15189:2022?

Focusing only on the containment features and ignoring ergonomics.

Ensuring that the space is as compact as possible to save costs.

Using an outdated design as long as it is compliant with previous regulations.

Designing the space to meet safety and containment standards while also considering the ergonomics and comfort of the staff.

None

10. In a laboratory that processes specimens from potentially infectious patients, what is the key element in maintaining both safety and the quality of test results?

Only focusing on maintaining safety protocols, as quality is irrelevant.

Ensuring that safety protocols are followed strictly while also implementing quality controls to prevent contamination and ensure accurate test results.

Allowing flexibility in safety protocols for ease of operation, even at the risk of contamination.

Ignoring safety protocols as long as the test results are accurate.

None

Time's up