Clinical Analysis Laboratory: FAQ | SRI International

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Clinical Analysis Laboratory: Frequently Asked Questions

Technical

1. Why was repeat testing performed?
2. I specified a particular prioritization of tests. Why do my results seem like the prioritization was not followed?
3. What is the standard protocol for chemistry analysis on low-volume samples?
4. Why was a manual WBC differential count/slide evaluation performed when I did not order it?

Reporting

1. How do I interpret the comment codes in the final report?

Compliance

1. Can I request extra tests not specified in the protocol?
2. Do I need to submit an amendment to the study protocol to SRI, even if it does not affect your lab?

Billing

1. How are repeats charged? 
2. Do you offer discounts for active clients?


Technical

1. Why was repeat testing performed?

Reasons include (but are not limited to) instrument flags, instrument malfunction, confirmation of a suspect result, etc. We do not charge for repeat tests if the retest is due to operator error or equipment malfunctions. Most retests are due to problems with samples (e.g., excessive hemolysis, lipemia, etc.).

2. I specified a particular prioritization of tests. Why do my results seem like the prioritization was not followed?

Our first priority is to run the samples as requested by the client or as specified in the study protocol; however, occasionally due to various technical issues, the priority of testing may be changed. Reasons for this include low sample volume (which will prompt dilution of the sample to take place which will in turn affect the priority of testing; see question #3 below), instrument flags, results falling outside of range, etc.

3. What is the standard protocol for chemistry analysis on low-volume samples?

Unless otherwise specified:

For samples with a volume of 90-120 µL:

  • T-Bili, Creat, Na , K, and Cl will be analyzed without dilution.
  • Remaining serum will be diluted with saline and the other requested tests will be analyzed.

For samples with volume of <90 µL:

  • Sample will be diluted with saline and analyzed for all tests requested with the exception of T-Bili, Creat, Na, K, and Cl.
  • T-Bili, Creat, Na, K, and Cl will be reported out as QNS (quanitity not sufficient).

Note: If possible, notify us in advance about low-volume samples. This will allow us to provide a more accurate quote.

4. Why was a manual WBC differential count/slide evaluation performed when I did not order it?

The main reason for performing manual WBC differential counts or slide evaluations is that the automated hematology instrument has alerted the operator with flagged results. These flags are often associated with WBC differential or RBC morphology. Therefore, the appearance of these flags prompts the operator to make a peripheral blood smear and perform a manual WBC differential count or a general slide evaluation.

Reporting

1. How do I interpret the comment codes in the final report?

These codes are exclusive to hematology analyses. They correspond to various results that the hematology analyzer flags. The majority of these flags are warnings related to platelets or RBC morphology. These flags are reported as codes on the Excel report as listed below:

10 = normal morphology * 2X = Anisocytosis
90 = abnormal morphology * 3X = Poikilocytosis
1 = platelet clumps seen * 4X = Hypochromia
2 = malarial parasites seen * 5X = Polychromasia
3 = platelet decreased * 6X = Microcytosis
4 = platelet increase * 7X = Macrocytosis

* Note: X equals the degree codes 1(1+), 2(2+), 3(3+), and 4(4+)

* For example:   
31 = 1+ poikilocytosis 64 = 4+ microcytosis

Compliance

1. Can I request extra tests not specified in the protocol?

A written request from the study director is required prior to testing. Additionally, a signed protocol amendment addressing additional tests will need to be submitted before the end of the study.

2. Do I need to submit an amendment to the study protocol to SRI, even if it does not affect your lab?

To avoid adverse findings by the FDA or other auditors, it is best to provide SRI with copies of all signed amendments. If the amendment does not affect the clinical laboratory portion of the study it is sufficient to notify SRI (mail or email) that an amendment has been issued and that it does not impact SRI’s portion of the study. An example of this notification is: Protocol Amendment #1 has been issued to clarify dose preparation methods. This does not impact the clinical pathology portions of the study conducted by SRI.

Billing

1. How are repeats charged? 

If the repeat testing requires a different set up in analysis (i.e., dilution) or requires additional reagent consumption, a repeat charge will apply.

2. Do you offer discounts for active clients?

Yes, we offer monthly discounts depending on the total amount of monthly submissions. (see test catalog).

For more information, please clinical-analysis [at] sri.com (contact us).