Laboratory IQCP Knowledge Quiz

To provide flexibility in meeting regulatory QC requirements appropriate to the tests performed.

IQCP applies to all nonwaived testing, including both existing and new test systems.

No, it does not necessarily reduce QC testing practices.

<p>Conducting a Risk Assessment is a critical step in developing an IQCP.</p> Signup and view all the answers

<p>Yes, laboratories are free to develop their own format that meets their specific needs.</p> Signup and view all the answers

<p>The primary purpose of developing an IQCP is to tailor quality control procedures to meet the specific needs of a laboratory's testing environment and patient population.</p> Signup and view all the answers

<p>The Risk Assessment worksheet helps laboratories evaluate and document their current quality activities, identifying potential areas of risk in their testing processes.</p> Signup and view all the answers

<p>Laboratories can modify their IQCP as needed by reviewing and adjusting their quality control procedures based on evolving testing practices or regulatory requirements.</p> Signup and view all the answers

<p>The IQCP Workbook includes fixed boxes for entering data for the Risk Assessment, Quality Control Plan, and Quality Assessment, which limits the amount of information that can be entered.</p> Signup and view all the answers

<p>Laboratories can access additional IQCP resources by visiting the CDC’s website or the CMS website for guidelines and downloadable materials.</p> Signup and view all the answers

<p>The Clinical Laboratory Improvement Amendments (CLIA) of 1988 requires laboratories to implement quality control procedures for monitoring testing accuracy and precision.</p> Signup and view all the answers

<p>Evaluating the complete testing process is crucial to ensure that all aspects of testing, from sample handling to result reporting, meet quality standards and reduce the risk of errors.</p> Signup and view all the answers

<p>Laboratories should document the specific quality control measures they will implement based on their risk assessment findings and unique testing conditions.</p> Signup and view all the answers

<p>Risk Assessment.</p> Signup and view all the answers

<p>Specimen, Test system, Reagent, Environment, Testing personnel.</p> Signup and view all the answers

<p>It describes the practices and procedures to reduce possible failures and errors in test processes.</p> Signup and view all the answers

<p>QA is the continuous monitoring of the effectiveness of the QCP.</p> Signup and view all the answers

<p>It must test two levels of external controls for each test system each day.</p> Signup and view all the answers

<p>Electronic controls, internal controls, proficiency testing, calibration, and maintenance.</p> Signup and view all the answers

<p>It provides insights into past performance and potential issues encountered.</p> Signup and view all the answers

<p>Their competency and training must be evaluated as they can introduce errors.</p> Signup and view all the answers

<p>To provide equivalent quality testing that meets CLIA QC regulations.</p> Signup and view all the answers

<p>QC reviews, PT performance reviews, and turnaround time reports.</p> Signup and view all the answers

<p>Data from verification or performance specifications, and historical QC data.</p> Signup and view all the answers

<p>They provide critical guidelines for evaluating potential errors and proper testing conditions.</p> Signup and view all the answers

<p>They enhance communication regarding quality standards and troubleshooting.</p> Signup and view all the answers

<p>To identify potential sources of error and implement strategies to reduce them.</p> Signup and view all the answers

<p>Identify the risks under the component most appropriate for the laboratory.</p> Signup and view all the answers

<p>The magnesium test system's manufacturer recommends external QC less frequently than CLIA requires.</p> Signup and view all the answers

<p>The laboratory must use two control materials of different concentrations each day of patient testing.</p> Signup and view all the answers

<p>Incomplete documentation of re-collection requests and some specimens being unprocessed for over 60 minutes.</p> Signup and view all the answers

<p>Investigations were conducted, and appropriate corrective actions were taken.</p> Signup and view all the answers

<p>Manufacturer’s instructions, technical bulletins, policies, and patient instructions.</p> Signup and view all the answers

<p>By reviewing two years of patient test results and external QC results with no reported problems.</p> Signup and view all the answers

<p>It indicates whether actions can be taken to reduce identified sources of error.</p> Signup and view all the answers

<p>There has been no personnel turnover in the past two years.</p> Signup and view all the answers

<p>They demonstrate the laboratory's capability to maintain accuracy and reliability in testing.</p> Signup and view all the answers

<p>Not all personnel properly documented requests for re-collection of specimens.</p> Signup and view all the answers

<p>To identify potential errors in preanalytic, analytic, and postanalytic phases.</p> Signup and view all the answers

<p>The use of internal control processes that perform QC on every reagent disc.</p> Signup and view all the answers

<p>By maintaining room temperature logs that demonstrate no problems for the past year.</p> Signup and view all the answers

<p>It may result in incorrect test results and compromise the accuracy of the testing process.</p> Signup and view all the answers

<p>Ignoring limitations could lead to erroneous interpretations of test results due to factors like lipemia or medication interference.</p> Signup and view all the answers

<p>Without monitors, there is a higher risk of obtaining misleading test results from insufficient specimens.</p> Signup and view all the answers

<p>Incorrect result transmission can lead to misdiagnosis and inappropriate patient management.</p> Signup and view all the answers

<p>It ensures positive patient identification, reducing the risk of errors in test result attribution.</p> Signup and view all the answers

<p>Untrained personnel may misuse the test system, leading to increased errors in test results.</p> Signup and view all the answers

<p>It prevents reagent degradation, ensuring their effectiveness and the accuracy of test results.</p> Signup and view all the answers

<p>Reagents should be evaluated for stability before use, and appropriate storage conditions must be restored.</p> Signup and view all the answers

<p>They ensure that the test system performs accurately under varying conditions and with different reagent lots.</p> Signup and view all the answers

<p>Poor reagent integrity can lead to incorrect test results, affecting patient diagnosis and treatment.</p> Signup and view all the answers

<p>By implementing systematic checks, training personnel, and adhering strictly to manufacturer’s guidelines.</p> Signup and view all the answers

<p>Reagent discs should not remain at room temperature longer than 48 hours to prevent degradation.</p> Signup and view all the answers

<p>It clarifies that those aspects do not pertain to the specific laboratory context, enhancing focus on relevant risks.</p> Signup and view all the answers

<p>Changes in personnel training, reagent lot numbers, or significant laboratory conditions merit updating quality control procedures.</p> Signup and view all the answers

<p>The components include identifying possible sources of error, what can go wrong, whether those sources can be reduced, and how to reduce them.</p> Signup and view all the answers

<p>Training personnel ensures they verify the use of proper specimen collection tubes and are aware of documentation and re-collection policies.</p> Signup and view all the answers

<p>The specimen must be rejected or properly re-labeled to prevent errors in test results.</p> Signup and view all the answers

<p>Following the manufacturer's instructions minimizes the risk of errors and ensures the reliability of test results.</p> Signup and view all the answers

<p>The internal control indicates whether the test system is functioning correctly and can highlight sampling errors.</p> Signup and view all the answers

<p>Testing personnel should review each QC result and only report patient results when QC is acceptable.</p> Signup and view all the answers

<p>Documenting these times helps ensure the proper processing of specimens and compliance with stability requirements.</p> Signup and view all the answers

<p>Without rejection criteria, incorrect or compromised specimens may be tested, leading to inaccurate results.</p> Signup and view all the answers

<p>Serum or plasma should be stored at 2°C to 8°C for 48 hours or at -10°C for up to 5 weeks to maintain stability.</p> Signup and view all the answers

<p>Reagents with different lot numbers should not be mixed unless the test system can identify or track them manually.</p> Signup and view all the answers

<p>The laboratory should have a protocol to review and verify test results before reporting them.</p> Signup and view all the answers

<p>Not following the instructions, such as incorrect reconstitution, can lead to unreliable test results.</p> Signup and view all the answers

<p>Laboratory practices can include internal controls, proper training of personnel, and strict adherence to manufacturer guidelines.</p> Signup and view all the answers

<p>The laboratory should identify outliers and perform corrective actions if necessary to ensure test system stability.</p> Signup and view all the answers

<p>The specified type of water required by the test system must be used to avoid invalid results.</p> Signup and view all the answers

<p>By implementing internal controls and following manufacturer guidelines diligently.</p> Signup and view all the answers

<p>Necessary actions help to mitigate risks and improve the overall quality and reliability of test results.</p> Signup and view all the answers

<p>Temperature fluctuations in the laboratory can impact the accuracy of test results.</p> Signup and view all the answers

<p>Failure to gather this information could lead to improper testing methods and unreliable results.</p> Signup and view all the answers

<p>By implementing a robust tracking and labeling system, laboratory personnel can ensure accurate identification.</p> Signup and view all the answers

<p>The test system must operate within this temperature range as per the manufacturer’s instructions.</p> Signup and view all the answers

<p>Proper ventilation is necessary to prevent temperature fluctuations that can affect test outcomes.</p> Signup and view all the answers

<p>Insufficient cleanliness can introduce variables that lead to incorrect test results.</p> Signup and view all the answers

<p>Perform regular checks and document environmental conditions consistently.</p> Signup and view all the answers

<p>By providing proper training and following established protocols for testing procedures.</p> Signup and view all the answers

<p>Internal controls serve as checks that help detect and prevent errors during the testing process.</p> Signup and view all the answers

<p>Proper humidity levels help prevent degradation of reagents and ensure accurate test outcomes.</p> Signup and view all the answers

<p>Insufficient space for workflow can lead to distractions and increase the likelihood of errors.</p> Signup and view all the answers

<p>They should assess adherence to manufacturer’s environmental requirements and conditions during testing.</p> Signup and view all the answers

<p>Reviewing past logs helps identify trends that could affect testing consistency and reliability.</p> Signup and view all the answers

<p>Improper test results can be reported due to lack of knowledge about specimen requirements.</p> Signup and view all the answers

<p>Update the policy to require that results are not verbally reported until they are entered into the LIS.</p> Signup and view all the answers

<p>It ensures that testing personnel are fully qualified to perform their tasks, minimizing errors.</p> Signup and view all the answers

<p>Training should cover specimen requirements and the proper performance of tests per manufacturer instructions.</p> Signup and view all the answers

<p>It could lead to unqualified personnel conducting tests, increasing the risk of inaccuracies.</p> Signup and view all the answers

<p>Implement double-check systems or automated entries in the LIS to minimize potential errors.</p> Signup and view all the answers

<p>Personnel should obtain the necessary formal certifications to ensure they are qualified.</p> Signup and view all the answers

<p>Competency assessments should be performed at least every six months for new employees.</p> Signup and view all the answers

<p>A strong laboratory policy helps standardize procedures and sets clear expectations for personnel.</p> Signup and view all the answers

<p>Failure to follow instructions could lead to inaccurate test results and compromised patient safety.</p> Signup and view all the answers

<p>If there are not enough personnel, testing might be rushed, leading to errors in handling specimens.</p> Signup and view all the answers

<p>It may result in unvalidated and unreliable test outcomes being reported.</p> Signup and view all the answers

<p>It ensures that specimens are collected correctly, which is vital for accurate testing.</p> Signup and view all the answers

<p>Implement a retraining program to address the identified gaps in knowledge and skills.</p> Signup and view all the answers

<p>Within 60 minutes.</p> Signup and view all the answers

<p>2°C to 8°C.</p> Signup and view all the answers

<p>Every 30 days.</p> Signup and view all the answers

<p>Check the reagent expiration dates.</p> Signup and view all the answers

<p>20°C to 25°C.</p> Signup and view all the answers

<p>To ensure the quality of the testing process and accuracy of test results.</p> Signup and view all the answers

<p>To prevent reagent degradation and ensure test reliability.</p> Signup and view all the answers

<p>Test and document external normal and abnormal controls.</p> Signup and view all the answers

<p>At least every six months.</p> Signup and view all the answers

<p>Move the test system away from the vents.</p> Signup and view all the answers

<p>Criteria for acceptable quality control.</p> Signup and view all the answers

<p>Room temperature.</p> Signup and view all the answers

<p>Update the policy to restrict verbal reporting.</p> Signup and view all the answers

<p>The laboratory director.</p> Signup and view all the answers

<p>The laboratory director must ensure the QCP is approved, signed, and dated while considering the clinical and legal responsibilities of providing accurate patient results.</p> Signup and view all the answers

<p>Kim identified opportunities by reviewing findings from the risk assessment and pinpointing failures such as unverified sample acceptability and temperature fluctuations.</p> Signup and view all the answers

<p>Kim could relocate the test system to a more suitable area within the laboratory to immediately resolve airflow and temperature issues.</p> Signup and view all the answers

<p>The acceptable range for room temperature is $20^ ext{o}C$ to $25^ ext{o}C$.</p> Signup and view all the answers

<p>Internal quality control must be documented with each patient test performed before any results are reported.</p> Signup and view all the answers

<p>If the time lapse exceeds 60 minutes, the specimen should be aliquoted and stored according to manufacturer’s instructions.</p> Signup and view all the answers

<p>External quality control should be run when laboratory conditions change significantly or if there is a mismatch between test results and clinical findings.</p> Signup and view all the answers

<p>The date and time must be documented on the reagent discs when they are removed from the refrigerator.</p> Signup and view all the answers

<p>Testing personnel must successfully meet all six CLIA elements for competency assessment.</p> Signup and view all the answers

<p>The main purpose of a QCP is to document and ensure reliable and accurate results for patient testing.</p> Signup and view all the answers

<p>Training should be documented with each new testing personnel and whenever retraining is indicated.</p> Signup and view all the answers

<p>Reagents at room temperature beyond 48 hours should not be used, as they may no longer be effective.</p> Signup and view all the answers

<p>The Specimen Rejection Policy outlines acceptable criteria for specimens and guides appropriate actions for improperly collected samples.</p> Signup and view all the answers

<p>External quality control testing should be performed every 30 days or on the first day of patient testing each month.</p> Signup and view all the answers

<p>Every 30 days, at change of reagent disc lot number, after significant lab changes, during training, or when test results are inconsistent with clinical findings.</p> Signup and view all the answers

<p>Reagent discs should not be used if they have been at room temperature for more than 48 hours.</p> Signup and view all the answers

<p>They must verify and document it as 'acceptable' before reporting patient results.</p> Signup and view all the answers

<p>The QCP should provide for immediate error detection, specify testing frequency, and contain criteria for acceptable QC results.</p> Signup and view all the answers

<p>The laboratory must perform QC as specified by the manufacturer's instructions, but not less than what is specified.</p> Signup and view all the answers

<p>The QA process involves monitoring and assessing laboratory practices to correct identified problems.</p> Signup and view all the answers

<p>The laboratory must update the risk assessment and modify the QCP accordingly.</p> Signup and view all the answers

<p>Training documentation must indicate successful demonstration of competency as per laboratory policy.</p> Signup and view all the answers

<p>The QCP must contain criteria that define the acceptable range of QC results.</p> Signup and view all the answers

<p>QC involves routine checks like documenting temperature and controls, while QA reviews these documents for trends and corrective actions.</p> Signup and view all the answers

<p>It ensures accountability and that the plan meets regulatory standards.</p> Signup and view all the answers

<p>The schedule should outline how frequently the QCP will be monitored and reevaluated.</p> Signup and view all the answers

<p>Activities can include recording control results, temperature logs, and documenting personnel training.</p> Signup and view all the answers

<p>It determines if quality activities are effective and leads to continuous improvements.</p> Signup and view all the answers

<p>They should review the outlier values and take corrective actions as necessary.</p> Signup and view all the answers

<p>QC data sheets, temperature logs, and specimen rejection logs are key types of logs that should be reviewed.</p> Signup and view all the answers

<p>Continuous monitoring is necessary to ensure that QA practices remain effective and to identify any recurring issues promptly.</p> Signup and view all the answers

<p>They must conduct an investigation to identify the cause and implement corrective actions necessary to resolve the failure.</p> Signup and view all the answers

<p>Temperature logs should be reviewed monthly for room, refrigerator, and freezer.</p> Signup and view all the answers

<p>Kim added a monthly supervisory review of instrument print-outs to ensure controls are run simultaneously with patient specimens.</p> Signup and view all the answers

<p>Documenting all QA activities is crucial for tracking compliance, evaluating effectiveness, and serving as a reference for future audits.</p> Signup and view all the answers

<p>They must document all corrections and implement corrective actions for affected patient results.</p> Signup and view all the answers

<p>External control runs are to be performed alongside patient specimens to ensure accuracy and reliability of results.</p> Signup and view all the answers

<p>The laboratory evaluates effectiveness through follow-up assessments and monitoring of the implemented corrective actions.</p> Signup and view all the answers

<p>If unacceptable specimens exceed the established threshold, the laboratory must conduct training or implement other corrective activities.</p> Signup and view all the answers

<p>A laboratory's QA practices must include outlining QA activities and policies for continuous monitoring.</p> Signup and view all the answers

<p>Failing to review and update the QCP may lead to undetected errors and insufficient preventative measures.</p> Signup and view all the answers

<p>Competency assessments and personnel records should be reviewed regularly to ensure compliance with CLIA requirements.</p> Signup and view all the answers

<p>Laboratories must update their standard operating procedures to incorporate any changes and address quality control problems.</p> Signup and view all the answers

<p>They ensure consistent handling of specimens that do not meet quality standards, which helps prevent the reporting of incorrect test results.</p> Signup and view all the answers

<p>Documenting corrective actions is essential for traceability, accountability, and future reference to improve quality control practices.</p> Signup and view all the answers

<p>An LIS facilitates timely and accurate transmission of patient results, ensuring data integrity from entry to final reporting.</p> Signup and view all the answers

<p>They verify that the testing equipment is working correctly and produce reliable results by performing built-in procedural checks.</p> Signup and view all the answers

<p>It identifies any changes in performance due to environmental factors, ensuring that the accuracy of test results is maintained.</p> Signup and view all the answers

<p>Conduct individual risk assessments for each location to address specific challenges and ensure consistent quality across all sites.</p> Signup and view all the answers

<p>Using expired reagents can compromise test accuracy and reliability, leading to incorrect patient results.</p> Signup and view all the answers

<p>Following manufacturer’s instructions ensures that all tests are performed correctly, minimizing errors and improving the accuracy of results.</p> Signup and view all the answers

<p>It evaluates whether laboratory practices align with established policies, ensuring compliance and identifying areas for improvement.</p> Signup and view all the answers

<p>It ensures that test results fall within a defined range, which confirms the reliability and accuracy of the test system.</p> Signup and view all the answers

<p>They safeguard sensitive equipment from power fluctuations, preventing disruptions that can affect test accuracy and reliability.</p> Signup and view all the answers

<p>The laboratory should investigate the error, perform necessary repairs or calibrations, and document the corrective action taken.</p> Signup and view all the answers

<p>It helps maintain a safe workspace by removing hazardous fumes and ensuring optimal conditions for accurate test results.</p> Signup and view all the answers

<p>Documentation should include the date of calibration, results, methods used, and the calibration material details as recommended by the manufacturer.</p> Signup and view all the answers

<p>It ensures accountability and verifies adherence to established policies and procedures.</p> Signup and view all the answers

<p>Annually after the first year of employment.</p> Signup and view all the answers

<p>Remedial training of testing personnel.</p> Signup and view all the answers

<p>Quarterly.</p> Signup and view all the answers

<p>All five components: specimen, test system, reagents, environment, and testing personnel.</p> Signup and view all the answers

<p>Rewrite the competency assessment training program to ensure it is up to date.</p> Signup and view all the answers

<p>The number, type, and frequency of testing control materials.</p> Signup and view all the answers

<p>The risk assessment should be updated accordingly.</p> Signup and view all the answers

<p>The IQCP is customized for the laboratory's specific testing considerations.</p> Signup and view all the answers

<p>Possible sources of error throughout the entire testing process.</p> Signup and view all the answers

<p>'N/A' indicates that particular components or actions do not apply to the situation.</p> Signup and view all the answers

<p>Actions taken by the laboratory to safeguard testing processes and practices.</p> Signup and view all the answers

<p>The IQCP should be reviewed periodically.</p> Signup and view all the answers

<p>It helps ensure that laboratory practices align with established protocols to minimize risk.</p> Signup and view all the answers

<p>The pre-analytic phase refers to all steps taken prior to the actual testing of a patient specimen, from the test request to specimen testing.</p> Signup and view all the answers

<p>Proficiency testing is the evaluation of unknown samples sent by a CMS approved PT program, and it is important for ensuring the accuracy and reliability of laboratory testing.</p> Signup and view all the answers

<p>The QA process benefits laboratory operations by providing an ongoing review to identify and correct problems in technical and non-technical functions.</p> Signup and view all the answers

<p>Quality Control involves procedures to detect and correct errors due to test system failures or environmental conditions, ensuring the accuracy and precision of test performance.</p> Signup and view all the answers

<p>The QCP must include practices, resources, and procedures to control the quality of a specific test process.</p> Signup and view all the answers

<p>The five components are Specimen, Test system, Reagent, Environment, and Testing Personnel.</p> Signup and view all the answers

<p>Verification ensures that the manufacturer's analytical claims of a test system are accurate and that it meets the laboratory's needs.</p> Signup and view all the answers

<p>The testing process encompasses all phases, including pre-analytic, analytic, and post-analytic, ensuring comprehensive evaluation from test request to result entry.</p> Signup and view all the answers

<p>Written policies are crucial for monitoring and assessing quality consistently, allowing laboratories to address and correct identified issues effectively.</p> Signup and view all the answers

<p>The laboratory should document the identified risks and implement corrective actions to mitigate them.</p> Signup and view all the answers

<p>Competency assessments must include regular evaluations and documentation of performance.</p> Signup and view all the answers

<p>Laboratories can keep a log of known errors encountered during specimen collection and handling.</p> Signup and view all the answers

<p>New personnel must undergo a formal training period before conducting tests independently.</p> Signup and view all the answers

<p>Written procedures ensure compliance with regulations and provide essential instructions for conducting assays.</p> Signup and view all the answers

<p>Monitoring QC results helps identify potential issues early and ensures the reliability of test results.</p> Signup and view all the answers

<p>Corrective actions should be recorded, including the nature of the error and the steps taken to resolve it.</p> Signup and view all the answers

<p>Environmental conditions, such as temperature and humidity, can significantly affect test system performance.</p> Signup and view all the answers

<p>External controls are materials used to verify the accuracy of test results by simulating patient specimens.</p> Signup and view all the answers

<p>Proficiency testing evaluates the performance of laboratory personnel and ensures the accuracy of test results.</p> Signup and view all the answers

<p>The risk assessment must evaluate potential sources of error across preanalytic, analytic, and postanalytic phases.</p> Signup and view all the answers

<p>Laboratories must document complaints and actions taken to resolve them effectively.</p> Signup and view all the answers

<p>The six elements are: observation, inquiry, written testing, direct observation of procedures, review of records, and assessment of overall performance.</p> Signup and view all the answers

<p>Accessibility to procedures ensures that personnel can follow them correctly during testing.</p> Signup and view all the answers

<p>Failure to follow manufacturer’s instructions can lead to incorrect test results and compromised patient safety.</p> Signup and view all the answers