Establishing a quality control material’s mean value when it’s not available from the control provider’s peer group or when the machine manufacturer’s name is not listed can be challenging, but there are several approaches you can consider
- Literature Review: Conduct a thorough literature review to find research articles, clinical guidelines, or studies that provide reference ranges or mean values for the specific test. This information might be available for certain tests and can provide a starting point.
- Internal Validation: First, ensure that the quality control material is suitable for your specific testing method and instrument. Perform a thorough internal validation to ensure accuracy and precision in your laboratory’s conditions
- Collect Data: Start by running multiple replicates of the quality control material over a defined period. This will help you collect a sufficient amount of data points for analysis
- Stability Assessment: Check the stability of the quality control material over time. Run the same material over consecutive days or weeks to ensure that its characteristics remain consistent.
- Calculate Mean and Standard Deviation: With the collected data, calculate the mean (average) and standard deviation of the test results. The mean will serve as the estimated mean value, and the standard deviation will indicate the variability of the measurements.
- Compare to Expected Range: If there is an expected range provided by regulatory bodies, scientific literature, or historical data from your lab, compare your calculated mean to this range. This can give you an initial indication of the quality control material’s validity.
- External Quality Assurance Programs: Participate in external quality assurance (EQA) or proficiency testing programs. These programs often provide reference values or peer group mean values that can help you establish your own laboratory’s mean value.
- Collaborate with Other Labs: Collaborate with other laboratories that perform similar tests. Sharing experiences and data can help establish an acceptable mean value range based on a broader set of data.
- Data Aggregation: If you’re unable to obtain data from your control provider’s peer group, consider aggregating data from multiple sources. Collect data from your own laboratory over time and combine it with data from other labs, if possible
- In-House Validation: Conduct your own validation studies using a representative sample of patient specimens. This can help you establish your own laboratory’s reference range or mean value.
- Clinical Judgment: Sometimes, clinical judgment based on the medical context can guide you in setting an initial mean value. Consider the patient population you’re serving, the expected clinical outcomes, and the purpose of the test.
- Manufacturer’s Support: Even if the machine manufacturer’s name is not listed, contact the manufacturer’s customer support. They might be able to provide information on the test methodology or suggest potential mean values based on their knowledge.
- Comparative Studies: Perform comparative studies with established methods or technologies to cross-reference results and establish an approximate mean value.
- Use Multiple Sources: If you can’t find a single source for mean values, consider using a range of sources and using the data to define a reasonable mean value range.
- Clinical Correlation: Correlate the test results with patient outcomes and clinical status. If possible, establish a link between the test values and the health of the patient.
- Document the Process: Whatever method you choose, document the process thoroughly. This documentation will be important for transparency, quality control, and potential audits.
Remember that while this process can help you estimate a mean value, it’s important to establish a robust quality control plan and continuously monitor your measurements to ensure the accuracy and reliability of your testing methods.
About the author
Dr. Sambhu Chakraborty is a distinguished consultant in quality accreditation for laboratories and hospitals. With a leadership portfolio that includes directorial roles in two laboratory organizations and a consulting firm, as well as chairmanship in a prominent laboratory organization, Dr. Chakraborty is a respected voice in the field. For further engagement or inquiries, Dr. Chakraborty can be contacted through email at director@iaqmconsultants.com and info@sambhuchakraborty.com. Additional resourcesand contact information are available on his websites, https://www.quality-pathshala.com and https://www.sambhuchakraborty.com, or via WhatsApp at +919830051583