Examination Processes and Release Of Test Results Part-4

Standard protocols often recommend using 20 samples for precision and two duplicates for accuracy.

To determine the appropriate sample size for your laboratory, consult manufacturer protocols, and check if the manufacturer provides specific recommendations for the number of samples needed. You can refer to the standard textbooks on laboratory methods to outline recommended sample sizes for verification. Research and adopt established protocols from relevant papers and publications.

Validation is a critical process to ensure the accuracy and reliability of laboratory tests. There are various protocols for determining accuracy, precision, and sample size. Laboratories can refer to the literature provided by your test kit manufacturer. The data they used for validation can serve as surrogate data for your validation process.

Validation is a research activity, so it’s essential to understand the correct protocols for sample performance and methodology modification.

Besides, laboratories should always keep ethical aspects in mind when conducting validations, including how many samples you should use and how the results are interpreted.

Yes, laboratories can sometimes extend the use of a test method to additional sample types. However, this should be done with caution and based on careful evaluation. You can use the protocols provided by the manufacturer for the recommended specimen as a starting point.

You may extend the manufacturer's protocol to other specimen types using the same procedures and validation methods.

Verification typically involves assessing precision, accuracy, linearity, biological reference intervals and interference. Laboratories should use approximately 20 samples for each of the above aspects. Apart from this, various small aspects must also be considered.

For precision, if you run 20 samples you must run four samples for five days. Two samples or reference materials which have accurate high & low-level values should be run in duplicates. For interference and biological reference intervals, run 20 samples each. For interference studies, you can use sample spiking methods to study the potential interferences.

Yes, QC runs should be performed for all equipment used in the laboratory, including backup machines. QC ensures the accuracy and reliability of results, regardless of whether the equipment is primarily used or serves as a backup. If you run samples today, QC must be run as well. If samples are processed less frequently, QC can be performed less often.

If your equipment or processes have particular guidelines for QC, you must follow them. If there are no specific guidelines, then risk analysis can be conducted to determine your own QC protocols.

No, it’s not a straightforward mathematical relationship.

There are certain variations you have to consider like preservatives added in QC, manufacturing conditions etc. QC materials are not identical to patient samples. They may have different stability characteristics and have been stored for longer periods. QC materials and patient samples may have been exposed to different environmental conditions during storage and transportation. It's essential to consider other factors and review QC results in conjunction with patient data to assess the overall accuracy and reliability of the laboratory's testing.

Yes, a laboratory director can delegate duties to qualified staff members, including monitoring QC activities. This is especially important in larger laboratories with multiple departments and a high volume of testing.

The amendment procedure form is not mandatory, but it can be included as part of your Standard Operating Procedures (SOP). You may either incorporate it directly into your manual or attach it as an annexe.

Yes, you can use multiple criteria like sample results falling within reference range samples which pass the Delta check, and samples correlating clinically. You can include all these protocols in your algorithm to ensure proper validation of results during the auto-verification process.

All body fluids including blood are part of the biomedical waste and are handled together. There is no need to segregate blood from other body fluids, as blood is a body fluid. Both blood and other body fluids should be treated as biomedical waste and disposed of according to biomedical waste management protocols.

An amendment involves changing or editing a report's results. Before you can amend a report, you must first perform a recall. A recall pulls back the report from circulation, allowing you to make the necessary amendments. Only after recalling the report can you proceed with the amendments to ensure the revised results are accurate.

If your control values are not within the expected range, but patient results remain consistent, it suggests that the control itself may be unstable. This indicates improper storage, handling, or usage of the control material. The stability of controls is crucial for accurate results, and if the controls are not properly maintained, they may lose their effectiveness.

The report must follow the format originally provided. You can refer to the given format to see the required content. It should include all relevant sections necessary for an appropriate and comprehensive report.

Yes, if it is relevant and your clinicians request all critical values to be reported, then you must report them. Ultimately, it is important to meet the requirements of the users. If the users or clinicians want to be informed of all critical values, regardless of the case’s criticality, you should comply and inform them.

 Timing may not be critical for all histopathological reports. However, in cases like frozen sections, the report must be completed within 30-35 minutes, as the patient is still in surgery. In short, while timing may not be as critical for all histopathology reports, it's important to consider the specific requirements of each case.

 The correct reference interval is the one most relevant to your local population. It’s essential to ensure that the reference range, whether from a kit or a universal/international textbook, aligns with the needs and comfort level of your clinician. Before adopting a reference interval, verify its suitability for both the local population and the clinicians who interpret the results.

 Yes, you can report values beyond the linear range if you have verified the reportable range.

For CRR studies, it is recommended to run at least 20 samples, and 19 out of those 20 should fall within your defined reference range. This ensures the accuracy and reliability of reporting values beyond the linear range.

Yes, if a biological reference range for your local population is available, it should be used. These ranges are more relevant to the individuals being tested and can improve the accuracy of diagnostic interpretations. ICMR is working on establishing reference intervals for all examination processes for various populations in India. Once it is available, laboratories in India can use that data to ensure accurate and meaningful results for patients.