Podcast
Questions and Answers
What is the main purpose of the IQCP option for laboratories?
What is the main purpose of the IQCP option for laboratories?
To provide flexibility in meeting regulatory QC requirements appropriate to the tests performed.
What types of testing does IQCP apply to according to the content?
What types of testing does IQCP apply to according to the content?
IQCP applies to all nonwaived testing, including both existing and new test systems.
Does the adoption of IQCP necessarily reduce existing QC testing practices?
Does the adoption of IQCP necessarily reduce existing QC testing practices?
No, it does not necessarily reduce QC testing practices.
What is one critical step mentioned in developing an IQCP for a test system?
What is one critical step mentioned in developing an IQCP for a test system?
Can laboratories develop their own format for IQCP documentation?
Can laboratories develop their own format for IQCP documentation?
What is the primary purpose of developing an Individualized Quality Control Plan (IQCP)?
What is the primary purpose of developing an Individualized Quality Control Plan (IQCP)?
Describe the role of the Risk Assessment worksheet in the IQCP process.
Describe the role of the Risk Assessment worksheet in the IQCP process.
How can laboratories adapt their IQCP over time?
How can laboratories adapt their IQCP over time?
What are the fixed components of the IQCP Workbook that laboratories must work within?
What are the fixed components of the IQCP Workbook that laboratories must work within?
Where can laboratories access additional resources for developing their IQCP?
Where can laboratories access additional resources for developing their IQCP?
What legislation requires laboratories to have quality control procedures?
What legislation requires laboratories to have quality control procedures?
Why is it important for the IQCP to evaluate the complete testing process?
Why is it important for the IQCP to evaluate the complete testing process?
What type of information should laboratories document in their Quality Control Plan?
What type of information should laboratories document in their Quality Control Plan?
What is the first step in the IQCP process?
What is the first step in the IQCP process?
List the five components that must be evaluated in a Risk Assessment.
List the five components that must be evaluated in a Risk Assessment.
What does the Quality Control Plan (QCP) describe?
What does the Quality Control Plan (QCP) describe?
Explain the purpose of Quality Assessment (QA) in the IQCP process.
Explain the purpose of Quality Assessment (QA) in the IQCP process.
What must a laboratory do if it does not adopt an IQCP?
What must a laboratory do if it does not adopt an IQCP?
What type of controls can be incorporated into a QCP?
What type of controls can be incorporated into a QCP?
Why is it important to assess historical QC data during the risk assessment?
Why is it important to assess historical QC data during the risk assessment?
How can testing personnel impact the risk assessment?
How can testing personnel impact the risk assessment?
What is the main goal of the IQCP?
What is the main goal of the IQCP?
What should be included in the Quality Assessment monitoring practices?
What should be included in the Quality Assessment monitoring practices?
What type of data should be reviewed to determine if additional quality procedures are needed?
What type of data should be reviewed to determine if additional quality procedures are needed?
What role do manufacturer’s instructions play in the risk assessment process?
What role do manufacturer’s instructions play in the risk assessment process?
How can partnerships with manufacturers strengthen the IQCP?
How can partnerships with manufacturers strengthen the IQCP?
What is the primary objective of a risk assessment in a laboratory setting?
What is the primary objective of a risk assessment in a laboratory setting?
What should a laboratory do if risks could fit under more than one risk assessment component?
What should a laboratory do if risks could fit under more than one risk assessment component?
Why is Kim focusing on the magnesium test system for the risk assessment?
Why is Kim focusing on the magnesium test system for the risk assessment?
What type of QC requirements does the lab follow according to CLIA guidelines?
What type of QC requirements does the lab follow according to CLIA guidelines?
What are some of the specimen handling issues noted by Kim in the risk assessment?
What are some of the specimen handling issues noted by Kim in the risk assessment?
What corrective action was taken for recorded outlier temperatures in the refrigerator and freezer logs?
What corrective action was taken for recorded outlier temperatures in the refrigerator and freezer logs?
What does Kim review to assess the risks associated with the testing process?
What does Kim review to assess the risks associated with the testing process?
How did Kim demonstrate the effectiveness of external QC in the laboratory?
How did Kim demonstrate the effectiveness of external QC in the laboratory?
In the risk assessment worksheet, what does the 'yes' or 'no' signify in column 3?
In the risk assessment worksheet, what does the 'yes' or 'no' signify in column 3?
What finding related to personnel training was noted in the laboratory?
What finding related to personnel training was noted in the laboratory?
What is the significance of the two years of successful PT performance reports?
What is the significance of the two years of successful PT performance reports?
What potential sources of error was identified by Kim regarding document gaps?
What potential sources of error was identified by Kim regarding document gaps?
Why is it crucial to evaluate the entire testing process during risk assessment?
Why is it crucial to evaluate the entire testing process during risk assessment?
What does Kim review to ensure compliance with internal controls?
What does Kim review to ensure compliance with internal controls?
How does the laboratory ensure the stability of the testing environment?
How does the laboratory ensure the stability of the testing environment?
What could happen if maintenance procedures are not consistent with the manufacturer's instructions?
What could happen if maintenance procedures are not consistent with the manufacturer's instructions?
Why is it important to consider the limitations of the test system?
Why is it important to consider the limitations of the test system?
What could be a consequence of lacking built-in monitors for inadequate specimen volume?
What could be a consequence of lacking built-in monitors for inadequate specimen volume?
What are the potential risks when the laboratory information system (LIS) does not transmit accurately?
What are the potential risks when the laboratory information system (LIS) does not transmit accurately?
How does a functioning bar code reader contribute to patient safety?
How does a functioning bar code reader contribute to patient safety?
What is a significant risk associated with not having a mechanism for trained personnel to operate the test system?
What is a significant risk associated with not having a mechanism for trained personnel to operate the test system?
Why is it necessary to monitor the storage conditions of reagents daily?
Why is it necessary to monitor the storage conditions of reagents daily?
What should be done if the temperature for storing reagents exceeds recommended limits?
What should be done if the temperature for storing reagents exceeds recommended limits?
What role do external controls play in the quality control process?
What role do external controls play in the quality control process?
What risks arise from not checking the integrity of reagents upon receipt?
What risks arise from not checking the integrity of reagents upon receipt?
How can the possible sources of error in a laboratory be effectively reduced?
How can the possible sources of error in a laboratory be effectively reduced?
What is a critical consideration when storing reagent discs?
What is a critical consideration when storing reagent discs?
Why is it important to indicate not applicable (N/A) for some risk assessment questions?
Why is it important to indicate not applicable (N/A) for some risk assessment questions?
What determines if a laboratory's quality control practices should change?
What determines if a laboratory's quality control practices should change?
What are the components involved in assessing potential sources of error in a laboratory risk assessment?
What are the components involved in assessing potential sources of error in a laboratory risk assessment?
How can training personnel help in reducing errors related to specimen handling?
How can training personnel help in reducing errors related to specimen handling?
What must be done if a specimen is improperly labeled?
What must be done if a specimen is improperly labeled?
Why is it important to follow the manufacturer's instructions for specimen collection and processing?
Why is it important to follow the manufacturer's instructions for specimen collection and processing?
What does the internal control in a test system indicate?
What does the internal control in a test system indicate?
What actions should be taken if quality control results are unacceptable?
What actions should be taken if quality control results are unacceptable?
What is the significance of documenting the collection time and receipt time in the laboratory?
What is the significance of documenting the collection time and receipt time in the laboratory?
What might happen if specified criteria for specimen rejection are not established?
What might happen if specified criteria for specimen rejection are not established?
How does temperature affect serum or plasma specimen stability?
How does temperature affect serum or plasma specimen stability?
What considerations must be made regarding reagent lot numbers in a laboratory?
What considerations must be made regarding reagent lot numbers in a laboratory?
What action should be taken if the test system does not prevent patient results from being reported when the QC is unacceptable?
What action should be taken if the test system does not prevent patient results from being reported when the QC is unacceptable?
Why is following the manufacturer’s instructions for reagent preparation critical?
Why is following the manufacturer’s instructions for reagent preparation critical?
In what ways can laboratory practices safeguard against potential errors during testing?
In what ways can laboratory practices safeguard against potential errors during testing?
What should a laboratory do when reviewing external QC log sheets?
What should a laboratory do when reviewing external QC log sheets?
What types of water should be used in the testing process according to manufacturer guidelines?
What types of water should be used in the testing process according to manufacturer guidelines?
How can identified sources of error related to reagents be reduced?
How can identified sources of error related to reagents be reduced?
Why is it necessary to have actions taken based on the risk assessment identified during laboratory operations?
Why is it necessary to have actions taken based on the risk assessment identified during laboratory operations?
What environmental factor can significantly affect test results according to the content?
What environmental factor can significantly affect test results according to the content?
What could be the impact of not gathering information on the testing process from the manufacturer’s instructions?
What could be the impact of not gathering information on the testing process from the manufacturer’s instructions?
How can personnel ensure that specimens are accurately identified throughout the testing process?
How can personnel ensure that specimens are accurately identified throughout the testing process?
What should be maintained within the temperature range of 20°C to 25°C?
What should be maintained within the temperature range of 20°C to 25°C?
What role does ventilation play in a laboratory testing environment?
What role does ventilation play in a laboratory testing environment?
What impact does clutter and debris have on laboratory testing?
What impact does clutter and debris have on laboratory testing?
What can laboratories do to ensure their environment meets testing requirements?
What can laboratories do to ensure their environment meets testing requirements?
How can the efficiency of testing personnel be improved?
How can the efficiency of testing personnel be improved?
What is the function of internal controls in minimizing testing errors?
What is the function of internal controls in minimizing testing errors?
How does maintaining appropriate humidity levels influence laboratory testing?
How does maintaining appropriate humidity levels influence laboratory testing?
What aspect of workspace design can affect laboratory testing efficiency?
What aspect of workspace design can affect laboratory testing efficiency?
What general environmental considerations should a laboratory assess?
What general environmental considerations should a laboratory assess?
Why is it important to investigate past temperature logs in a laboratory?
Why is it important to investigate past temperature logs in a laboratory?
What potential error can occur if testing personnel are not properly trained?
What potential error can occur if testing personnel are not properly trained?
How can a laboratory mitigate risks associated with verbal reporting of test results?
How can a laboratory mitigate risks associated with verbal reporting of test results?
Why is it important for competency assessments to include all CLIA required elements?
Why is it important for competency assessments to include all CLIA required elements?
What should be included in routine training for testing personnel?
What should be included in routine training for testing personnel?
What risk is associated with a lack of documentation for CLIA-required competency assessments?
What risk is associated with a lack of documentation for CLIA-required competency assessments?
What action can be taken if personnel make transcription errors while reporting results?
What action can be taken if personnel make transcription errors while reporting results?
What should be done if there are no formal certifications for laboratory personnel when required?
What should be done if there are no formal certifications for laboratory personnel when required?
How often should competency assessments be conducted for new employees?
How often should competency assessments be conducted for new employees?
What role does a laboratory policy play in reducing testing errors?
What role does a laboratory policy play in reducing testing errors?
What could happen if the testing personnel don’t follow manufacturer’s instructions?
What could happen if the testing personnel don’t follow manufacturer’s instructions?
In what scenario might inadequate personnel pose a risk in the laboratory?
In what scenario might inadequate personnel pose a risk in the laboratory?
What could be a consequence of improperly trained personnel signing off on test results?
What could be a consequence of improperly trained personnel signing off on test results?
Why should training on proper specimen collection be mandatory?
Why should training on proper specimen collection be mandatory?
What should a laboratory do if personnel are found to be inadequately trained?
What should a laboratory do if personnel are found to be inadequately trained?
What is the maximum time within which whole blood must be run after collection?
What is the maximum time within which whole blood must be run after collection?
What temperature range is recommended for storing serum or plasma?
What temperature range is recommended for storing serum or plasma?
How often should external normal and abnormal controls be tested according to the manufacturer’s instructions?
How often should external normal and abnormal controls be tested according to the manufacturer’s instructions?
What must personnel do before using reagent discs for testing?
What must personnel do before using reagent discs for testing?
What is the acceptable room temperature range for operating the test system?
What is the acceptable room temperature range for operating the test system?
What is the role of a Quality Control Plan (QCP) in a laboratory?
What is the role of a Quality Control Plan (QCP) in a laboratory?
Why is it important to document monitoring of storage conditions for reagents?
Why is it important to document monitoring of storage conditions for reagents?
What should testing personnel do if test results do not match patient symptoms?
What should testing personnel do if test results do not match patient symptoms?
How frequently should competency assessments be conducted for new employees?
How frequently should competency assessments be conducted for new employees?
What action should be taken if the test system is located near air conditioning vents?
What action should be taken if the test system is located near air conditioning vents?
What is one major component that must be included in a QCP?
What is one major component that must be included in a QCP?
What should be recorded daily during a laboratory testing process?
What should be recorded daily during a laboratory testing process?
What must be done if testing personnel verbally release results before entering them into the LIS?
What must be done if testing personnel verbally release results before entering them into the LIS?
What is the ultimate responsibility for the development of a QCP in a laboratory?
What is the ultimate responsibility for the development of a QCP in a laboratory?
What are the primary responsibilities of the laboratory director when considering a Quality Control Plan (QCP)?
What are the primary responsibilities of the laboratory director when considering a Quality Control Plan (QCP)?
How did Kim identify opportunities to improve the QCP within the laboratory?
How did Kim identify opportunities to improve the QCP within the laboratory?
What might Kim incorporate into her QCP to address the fluctuations in room temperature?
What might Kim incorporate into her QCP to address the fluctuations in room temperature?
What is the acceptable range for room temperature checks according to the QCP?
What is the acceptable range for room temperature checks according to the QCP?
How often should internal quality control be documented according to the QCP?
How often should internal quality control be documented according to the QCP?
What should be done if a specimen collection time exceeds 60 minutes before reaching the laboratory?
What should be done if a specimen collection time exceeds 60 minutes before reaching the laboratory?
What triggers the need for external quality control to be run more frequently than usual?
What triggers the need for external quality control to be run more frequently than usual?
What documentation is required upon removing reagent discs from refrigeration?
What documentation is required upon removing reagent discs from refrigeration?
What is one essential element of competency assessment for testing personnel?
What is one essential element of competency assessment for testing personnel?
What is the main purpose of a Quality Control Plan (QCP)?
What is the main purpose of a Quality Control Plan (QCP)?
When should training for testing personnel be documented according to the QCP?
When should training for testing personnel be documented according to the QCP?
What should be done if reagents are left at room temperature beyond the specified period?
What should be done if reagents are left at room temperature beyond the specified period?
What role does the Specimen Rejection Policy play in the QCP?
What role does the Specimen Rejection Policy play in the QCP?
How frequently should external quality control testing be performed?
How frequently should external quality control testing be performed?
What are the recommended circumstances under which a laboratory must run external controls?
What are the recommended circumstances under which a laboratory must run external controls?
What is the maximum amount of time that reagent discs can be at room temperature before they should not be used?
What is the maximum amount of time that reagent discs can be at room temperature before they should not be used?
How must laboratories document the internal QC status for patient tests?
How must laboratories document the internal QC status for patient tests?
What key components should a Quality Control Plan (QCP) include to ensure effective monitoring?
What key components should a Quality Control Plan (QCP) include to ensure effective monitoring?
What actions should be taken if a laboratory's QC activities do not align with the manufacturer's instructions?
What actions should be taken if a laboratory's QC activities do not align with the manufacturer's instructions?
What is the purpose of the QA process in a laboratory setting?
What is the purpose of the QA process in a laboratory setting?
How should a laboratory respond if a risk assessment identifies new issues?
How should a laboratory respond if a risk assessment identifies new issues?
What specific documentation is required for training of testing personnel in a laboratory?
What specific documentation is required for training of testing personnel in a laboratory?
What criteria should be established in a laboratory's QCP to assess QC acceptability?
What criteria should be established in a laboratory's QCP to assess QC acceptability?
What is the difference between Quality Control (QC) and Quality Assessment (QA) activities?
What is the difference between Quality Control (QC) and Quality Assessment (QA) activities?
Why is it crucial for the Laboratory Director to review and sign the QCP document?
Why is it crucial for the Laboratory Director to review and sign the QCP document?
What should the schedule for evaluating a QCP include?
What should the schedule for evaluating a QCP include?
What types of QC activities can be considered as part of a laboratory's risk management?
What types of QC activities can be considered as part of a laboratory's risk management?
What is the significance of a laboratory's QA monitoring program?
What is the significance of a laboratory's QA monitoring program?
What should a laboratory do if there are outlier results in their control documentation?
What should a laboratory do if there are outlier results in their control documentation?
What are the types of logs that should be reviewed for effective quality assessment?
What are the types of logs that should be reviewed for effective quality assessment?
Why is continuous monitoring necessary in a laboratory's QA process?
Why is continuous monitoring necessary in a laboratory's QA process?
What should laboratories do in the event of a testing process failure?
What should laboratories do in the event of a testing process failure?
How often should temperature logs be reviewed at Happy Day Physicians Group?
How often should temperature logs be reviewed at Happy Day Physicians Group?
What extra step was added to the QCP to reduce the risk of errors based on Kim's findings?
What extra step was added to the QCP to reduce the risk of errors based on Kim's findings?
Why is documenting all QA activities crucial in a laboratory?
Why is documenting all QA activities crucial in a laboratory?
What corrective action must laboratories take upon discovering an error in their QA process?
What corrective action must laboratories take upon discovering an error in their QA process?
What is the role of external control runs in testing according to Kim's findings?
What is the role of external control runs in testing according to Kim's findings?
How does the laboratory evaluate the effectiveness of corrective actions taken?
How does the laboratory evaluate the effectiveness of corrective actions taken?
What should a laboratory do if unacceptable specimens exceed a certain threshold?
What should a laboratory do if unacceptable specimens exceed a certain threshold?
What is one of the key components that must be included in a laboratory's QA practices?
What is one of the key components that must be included in a laboratory's QA practices?
What outcome arises from failing to review and update the Quality Control Plan (QCP)?
What outcome arises from failing to review and update the Quality Control Plan (QCP)?
How often should competency assessments and personnel records be reviewed?
How often should competency assessments and personnel records be reviewed?
What action must be taken if manufacturer’s instructions are not followed correctly?
What action must be taken if manufacturer’s instructions are not followed correctly?
What is the importance of having written procedures for managing unacceptable specimens in a laboratory?
What is the importance of having written procedures for managing unacceptable specimens in a laboratory?
Why must laboratories document corrective actions and resolutions when quality control values are out of range?
Why must laboratories document corrective actions and resolutions when quality control values are out of range?
What role does a Laboratory Information System (LIS) play in an effective quality control plan?
What role does a Laboratory Information System (LIS) play in an effective quality control plan?
Describe the function of system controls and function checks according to manufacturer’s instructions.
Describe the function of system controls and function checks according to manufacturer’s instructions.
How does performing an evaluation of instrument and reagent stability after relocation benefit the laboratory?
How does performing an evaluation of instrument and reagent stability after relocation benefit the laboratory?
What should a laboratory do to manage potential risks associated with multiple testing locations?
What should a laboratory do to manage potential risks associated with multiple testing locations?
Explain the significance of ensuring all reagents are used within their manufacturer’s designated expiration dates.
Explain the significance of ensuring all reagents are used within their manufacturer’s designated expiration dates.
Why is it necessary for all testing personnel to adhere to the manufacturer’s instructions during specimen collection?
Why is it necessary for all testing personnel to adhere to the manufacturer’s instructions during specimen collection?
What does the assessment of QA activity involve and why is it essential?
What does the assessment of QA activity involve and why is it essential?
What is the purpose of having an established acceptable calibration range in the laboratory?
What is the purpose of having an established acceptable calibration range in the laboratory?
How do surge protectors contribute to laboratory safety and operational efficiency?
How do surge protectors contribute to laboratory safety and operational efficiency?
What corrective action should be taken if a test system indicates mechanical or electronic errors?
What corrective action should be taken if a test system indicates mechanical or electronic errors?
Why is adequate ventilation important in a laboratory testing environment?
Why is adequate ventilation important in a laboratory testing environment?
What should be included in the documentation of calibration procedures followed in a laboratory?
What should be included in the documentation of calibration procedures followed in a laboratory?
Why is it necessary for QA activities to be reviewed and signed by the Supervisor?
Why is it necessary for QA activities to be reviewed and signed by the Supervisor?
What frequency is indicated for the Competency Assessment of testing personnel?
What frequency is indicated for the Competency Assessment of testing personnel?
What is one corrective action taken when QA activities indicate a variation from established procedures?
What is one corrective action taken when QA activities indicate a variation from established procedures?
How often does the Laboratory Director review and sign QC logs?
How often does the Laboratory Director review and sign QC logs?
What should laboratories consider as part of their risk assessment according to the IQCP process?
What should laboratories consider as part of their risk assessment according to the IQCP process?
What action is suggested for updating the competency assessment training program?
What action is suggested for updating the competency assessment training program?
What elements should a laboratory include in its Quality Control Plan (QCP)?
What elements should a laboratory include in its Quality Control Plan (QCP)?
How should a laboratory respond if identified risks in the risk assessment are no longer applicable?
How should a laboratory respond if identified risks in the risk assessment are no longer applicable?
What is a key characteristic that makes an IQCP unique to each laboratory?
What is a key characteristic that makes an IQCP unique to each laboratory?
What type of errors should laboratories gather information on when performing risk assessments?
What type of errors should laboratories gather information on when performing risk assessments?
In the context of QA activities, what does 'N/A' signify in the assessment process?
In the context of QA activities, what does 'N/A' signify in the assessment process?
Which actions are considered within internal controls of a laboratory?
Which actions are considered within internal controls of a laboratory?
How often should the IQCP be reviewed to ensure its accuracy and relevance?
How often should the IQCP be reviewed to ensure its accuracy and relevance?
What is the significance of verifying compliance with internal controls during the QA process?
What is the significance of verifying compliance with internal controls during the QA process?
What does the term 'pre-analytic phase' refer to in laboratory testing?
What does the term 'pre-analytic phase' refer to in laboratory testing?
What is proficiency testing and why is it important for laboratories?
What is proficiency testing and why is it important for laboratories?
How does a Quality Assessment (QA) process benefit laboratory operations?
How does a Quality Assessment (QA) process benefit laboratory operations?
What is the role of Quality Control (QC) in ensuring test accuracy?
What is the role of Quality Control (QC) in ensuring test accuracy?
What must a laboratory include in its Quality Control Plan (QCP)?
What must a laboratory include in its Quality Control Plan (QCP)?
What are the five components evaluated in a Risk Assessment (RA)?
What are the five components evaluated in a Risk Assessment (RA)?
How does verification contribute to laboratory testing processes?
How does verification contribute to laboratory testing processes?
What is the significance of the testing process in laboratory operations?
What is the significance of the testing process in laboratory operations?
Why is it important for laboratories to establish written policies for Quality Assessment?
Why is it important for laboratories to establish written policies for Quality Assessment?
What steps should a laboratory take if it identifies risks during the risk assessment?
What steps should a laboratory take if it identifies risks during the risk assessment?
What are two required elements of an ongoing competency assessment program for laboratory personnel?
What are two required elements of an ongoing competency assessment program for laboratory personnel?
How can laboratories monitor specimen handling errors?
How can laboratories monitor specimen handling errors?
What is a necessary practice for new laboratory personnel regarding training?
What is a necessary practice for new laboratory personnel regarding training?
What role do written procedures play in laboratory testing according to CLIA?
What role do written procedures play in laboratory testing according to CLIA?
What is the significance of monitoring QC results for shifts and trends?
What is the significance of monitoring QC results for shifts and trends?
How should corrective actions be documented in a laboratory setting?
How should corrective actions be documented in a laboratory setting?
What impact do environmental conditions have on laboratory testing?
What impact do environmental conditions have on laboratory testing?
What are external controls and why are they important in quality control?
What are external controls and why are they important in quality control?
What is the purpose of conducting proficiency testing (PT) in laboratories?
What is the purpose of conducting proficiency testing (PT) in laboratories?
What factors must be considered during the risk assessment in laboratories?
What factors must be considered during the risk assessment in laboratories?
How should laboratories address complaints received from stakeholders?
How should laboratories address complaints received from stakeholders?
What are the six elements required for competency assessment according to CLIA?
What are the six elements required for competency assessment according to CLIA?
Why is it important for laboratory procedures to be readily accessible to testing personnel?
Why is it important for laboratory procedures to be readily accessible to testing personnel?
What might be the consequences of not adhering to manufacturer’s instructions during testing?
What might be the consequences of not adhering to manufacturer’s instructions during testing?
Flashcards are hidden until you start studying
Study Notes
CLIA and IQCP
- The Clinical Laboratory Improvement Amendments (CLIA) regulations of 1988 require laboratories to have quality control (QC) procedures to assure accuracy and precision of testing.
- Laboratories have the option of creating an individualized quality control plan (IQCP) for each test system to tailor the QC plan to their specific needs.
- IQCP is an all-inclusive approach to ensuring quality in the laboratory.
- IQCP covers many practices including ensuring that the number of QC materials tested is appropriate for the frequency of testing.
- The IQCP approach is voluntary. A laboratory must test two levels of external controls for each test system on each day of testing unless they choose to adopt an IQCP.
IQCP Steps
- The IQCP process involves three steps: Risk Assessment, Quality Control Plan (QCP), and Quality Assessment (QA)
- The IQCP must address potential failures and errors in the entire testing process: preanalytic (before testing), analytic (testing) and postanalytic (after testing) phases of testing.
Risk Assessment
- This step aims to identify and analyze potential failures and errors that could occur during the testing process.
- It must include an evaluation of these five components: specimen, test system, reagent, environment, and testing personnel.
Quality Control Plan (QCP)
- The QCP is a written document describing the practices and procedures your laboratory performs to reduce the chance of potential failures and errors in your test processes.
- It must ensure that the accuracy and reliability of the test results are appropriate for patient care.
- Examples of practices and procedures that may be included in this plan:
- Electronic controls
- Internal controls
- Proficiency testing (PT)
- Calibration
- Maintenance
- Training and competency assessment
Quality Assessment (QA)
- The QA is a continuous process of monitoring the effectiveness of the QCP.
- Potential practices and processes to consider for monitoring effectiveness of a QCP:
- QC reviews
- PT performance reviews
- Chart reviews
- Specimen rejection logs
- Turnaround time reports
- Complaint reports
Getting Started With Risk Assessment
- To begin your risk assessment, identify the risks under the most appropriate component for your laboratory.
- Review and assess the following information:
- Laboratory procedures/standard operating procedures (SOPs)
- Manufacturer’s instructions/package inserts
- Instrument and troubleshooting manuals
- Manufacturer’s alerts and bulletins
- Calibration data
- Data obtained through verification or establishment of performance specifications
- FDA alerts
- Historical QC data, including data from a previously conducted equivalent quality control study
- Instrument correlation data
- PT results and data
- Records of complaints and corrected reports
- Regulatory and accreditation requirements
- Scientific publications
- Test process flow charts or maps
- Testing personnel training and competency records
- Pay particular attention to the following package insert sections:
- Intended use
- Patient preparation
- Limitations
- Environmental requirements
- QC frequency
- Specimen requirements
- Reagent storage
- Maintenance
- Calibration
- Interfering substances
Scenario: Happy Day Physicians Group
- Dr. Martin, laboratory director at Happy Day Physicians Group, is considering implementing an IQCP.
- The lab supervisor, Kim, is tasked with evaluating the magnesium test performed using the Acme Chemotrific System-Magnesium.
- Dr. Martin requested the evaluation because the manufacturer's instructions recommend performing QC less frequently than required by CLIA.
- Kim has gathered supporting data to assess the laboratory's current practices:
- The test system is FDA cleared and falls under the moderate complexity category under CLIA.
- The laboratory follows CLIA's regulatory requirements for QC, testing two control materials at different concentrations each day of patient testing.
- The Acme Chemotrific System-Magnesium package insert includes:
- Specimen collection time and tube requirements
- Test limitations
- Acceptable results criteria
- An internal control process that performs internal QC on every reagent disc
- Recommendations for performing external controls at least every 30 days, or when there is a significant change in laboratory conditions, training or retraining of personnel is indicated, or test results do not match patient symptoms or clinical findings.
- The laboratory has two years of successful PT performance reports.
- Test performance specification verification studies demonstrate the test system's accuracy and stability.
- A review of the specimen receipt logs for the past two years shows documentation gaps when requesting specimen re-collection.
- A review of instrument maintenance logs shows no problems with the test system’s mechanics for the past two years.
- Review of patient test results and two levels of external QC results for the past two years demonstrates no problems with the test system. QC outliers were resolved with corrective actions. Review of troubleshooting logs shows no indication of problems with the test system or patient results reporting.
- A review of the lot-to-lot reagent logs demonstrates no problems or indications of problems for the past six months.
- A review of temperature logs for the past year shows no problems with room temperature. A review of refrigerator and freezer temperature logs demonstrates minimal outlier temperatures with investigations and appropriate corrective action.
- A review of personnel training records for the past two years demonstrates no personnel turnover.
- Dr. Martin should continue to gather more data to support the risk assessment.
- This data will help determine if the current quality procedures are adequate or if additional or different activities are needed to reduce potential failures and errors.
- This supporting data will determine which risks need to further evaluated, and which components will be included in the next step of the IQCP implementation.
Risk Assessment Steps
- Risk assessment is a vital process for laboratories to identify and minimize potential errors in their testing processes.
- It involves analyzing different components of the testing process to identify potential sources of error.
- The goal is to develop strategies to reduce or eliminate these sources of error, ensuring accurate and reliable test results.
Specimen Risk Assessment
- Focus: The specimen is the primary source of information for diagnosis. Errors in specimen handling can impact test accuracy.
- Key Considerations:
- Documentation of Specimen Re-collection: The laboratory should have clear policies and procedures in place for re-collecting specimens and these procedures should be thoroughly documented.
- Specimen Stability: Test results can be influenced by the time that lapses between specimen collection and testing. Laboratories need to adhere to defined timelines for processing and storing specimens.
- Specimen Integrity: Ensuring specimens are properly labeled and identified throughout the testing process is crucial.
- Specimen Rejection Criteria: Laboratories should have well-defined criteria for rejecting specimens that are not suitable for testing.
Test System Risk Assessment
- Focus: The test system, including its components and procedures, is essential for generating test results.
- Key Considerations:
- Manufacturer’s Instructions: Following the test system’s manufacturer’s instructions is paramount.
- Quality Control (QC): Regular QC checks help assess the test system’s reliability and ensure accuracy.
- System Limitations: Laboratories should be aware of the test system’s limitations, such as any interfering factors that could affect performance.
- Internal Controls: Test systems often have built-in internal controls to detect potential errors.
Reagent Risk Assessment
- Focus: Reagents are substances that interact with the specimen during testing. Proper handling and storage are critical.
- Key Considerations:
- Storage: Reagents should be stored according to the manufacturer’s instructions to maintain their integrity and stability.
- Expiration Dates: Expired reagents can compromise test results. Laboratories must carefully check expiration dates before using reagents.
- Lot-to-Lot Variations: Some reagent batches may differ slightly from others. Laboratories should implement procedures to account for such variations.
- External QC: Using external quality controls can help identify problems related to the reagent or its performance.
Environment Risk Assessment
- Focus: The laboratory environment and its factors can influence the testing process and the validity of results.
- Key Considerations:
- Temperature: Maintaining the appropriate temperature range for the test system is crucial.
- Ventilation: Adequate ventilation helps to maintain appropriate humidity and air quality within the lab.
- Space: Adequate work space and appropriate lighting are essential for a smooth testing process.
- Cleanliness: A clean and clutter-free workspace helps prevent contamination and enhances accuracy.
Testing Personnel Risk Assessment
- Focus: Well-trained and competent testing personnel are a fundamental part of accurate testing.
- Key Considerations:
- Training: Laboratories should invest in comprehensive training programs for their staff to ensure they are proficient in test procedures, safety protocols, and quality control measures.
- Competency Assessments: Regular competency assessments help evaluate staff expertise and identify areas for improvement.
- Policies and Procedures: Clearly defined policies should guide staff behavior and decision-making during testing.
Risk Assessment
-
The risk assessment process involves identifying potential sources of error, evaluating their impact, and determining strategies to reduce these errors.
-
The risk assessment worksheet consists of four columns:
- What are our possible sources of error?
- What can go wrong?
- Can our identified sources of error be reduced?
- How can we reduce the identified sources of error?
-
The risk assessment worksheet is used to document and track each potential error source and its associated mitigation strategy.
-
In the example scenario, the risk assessment component "Testing Personnel" identified several potential errors, including:
- Improperly trained personnel
- Competency assessment not encompassing all CLIA required elements
- Verbal reporting of test results before entry into the laboratory information system (LIS)
-
The risk assessment worksheet is also used to assess general concerns related to testing personnel by considering questions such as:
- Whether laboratory personnel have the required certifications or licenses,
- If there is adequate staff to perform patient testing effectively and safely,
- If documentation of CLIA-required competency assessments is available for all staff,
- If testing personnel are trained on specimen requirements (collection and type),
- If they are trained to follow the manufacturer’s instructions,
- If they are prone to transcription errors when reporting results.
Quality Control Plan (QCP)
-
The QCP is a documented plan that outlines the practices, procedures, and resources your laboratory uses to assure the quality of a testing process.
-
The QCP aims to monitor and ensure the accuracy and reliability of test results, ensuring the quality of testing is adequate for patient care.
-
The QCP must include the number, type, and frequency of testing control materials, as well as criteria for acceptable quality control.
-
The QCP should also include various elements based on the risk assessment, such as:
- Electronic controls
- Equipment maintenance
- Internal controls
- Personnel training and competency assessment
- Equipment calibration
- Other specified quality control activities
-
The laboratory director is ultimately responsible for the development and implementation of the QCP.
-
The Happy Day Physicians Group QCP included quality control activities such as:
- Temperature checks of the room, refrigerator, and freezer
- Verification of specimen collection tubes for acceptability
- Verification of specimen collection time and time received by the laboratory
- Internal quality control performed with each reagent disc
- External quality control performed with normal and abnormal values
- Reagent disc storage documentation
- Training documentation
- Competency assessment documentation
-
The Happy Day Physicians Group QCP also highlighted the importance of documenting QC activities, such as:
- Temperature logs
- Specimen rejection logs
- Quality control logs
- Training records
- Competency assessment records
-
Similar to the risk assessment, a general checklist of QC questions can be used to comprehensively assess the laboratory’s QC procedures. These questions aim to ensure the QC activities:
- Provide for immediate detection of errors for each phase of the testing process
- Specify the number, type, and frequency of testing QC material(s)
- Contain criteria to determine acceptable QC results
- Require the laboratory to perform QC as specified by the manufacturer’s instructions
- Indicate that the Laboratory Director has reviewed, signed and dated the QCP document
-
The QCP is a crucial component of ensuring the quality of laboratory testing and ultimately contributing to providing accurate and reliable patient results.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
