| CLIA |
| Is the QBC STAR considered CLIA waived? |
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Currently, all of the QBC Systems are moderately complex.
The QBC STAR was specifically designed to be CLIA waived and QBC Diagnostics has applied for CLIA Waiver.
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| Controls and Diagnostics |
| How often do I have to run external controls on the QBC Star? |
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Traditional quality controls consists of running at least two levels of external control material each day of patient testing.
The QBC STAR qualifies for EQC Option 1. (See next question.)
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| What is EQC (Equivalent Quality Control) Option 1? |
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Advances in laboratory technology have led to test systems that include internal monitoring systems or controls that check all or a portion of the test system's analytical components each time a test is performed.
The CLIA regulations now allow the laboratory to reduce the frequency of testing external quality control materials for certain test systems.
The QBC Star qualifies for EQC Option 1.
More detailed information about the CLIA requirement pertaining to equivalent QC procedures can be found at www.cms.hhs.gov/clia.
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| My controls arrived warm (ice packs were melted); can I still use the controls? |
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The controls may work in the short term, but may be prone to early degradation.
If the controls are warm, a replacement set can be requested by calling QBC Technical Support at 866-265-1486.
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| Is there a QC program for the daily control tracking? |
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There is an Inter-Lab Quality Control (ILQC) program that can be ordered through QBC Diagnostics.
It is administered by R&D Systems (the OEM manufacturer of the control material).
It will provide monthly peer comparisons with statistical evaluation of your results.
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| Sample Collection and Analysis |
| What type of sample is required for QBC STAR testing? |
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Whole blood samples collected from either a capillary fingerstick or a venous blood draw (EDTA purple top tube).
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| How much blood is required to test on the QBC STAR? |
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The Star Tube requires 70µl of blood.
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| What tube types can be used with the QBC STAR? |
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The QBC STAR is designed to work only with the QBC STAR Tube.
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| What collection method should be used for the QBC STAR Tube? |
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The STAR Tube can be used with fingerstick or venous blood (EDTA tube).
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| How long can a venous sample be stored prior to testing on the QBC Systems? |
Refrigerated samples stored at 36 to 46°F are stable for up to 8 hours.
Note: Bring the sample back to room temperature before you prepare the STAR tube.
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| Can a sample be processed more than once on the QBC STAR? |
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Yes, once centrifuged the QBC STAR Tubes can be analyzed more than one time.
The tube must be stored in an upright position and is stable at room temperature for up to four hours.
Simply insert the tube and begin the STAR as usual.
During its initial slow spin, The STAR will recognize that the tube has already been centrifuged and move directly to the scanning phase.
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| How can I get results from my QBC STAR into other external systems (e.g., EMR, LIS, etc.)? |
We recommend contacting Apex Healthware.
Apex Healthware is a developer of affordable HL7 interfaces and laboratory information systems.
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| Printing |
| What external printers are compatible with the QBC Star? |
Brother HL-5240 & Brother HL-5250DN
Note: Other printers may work with the systems if they speak Epson language (ESC/P2/LQ).
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| What kind of paper can be used with the QBC STAR's internal printer? |
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The QBC STAR uses 2.25-inch thermal paper tape.
Replacement rolls are available from QBC Diagnostics, Inc.
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| I just changed the paper on the STAR and now the printouts are blank. |
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Verify that the paper is turned to the thermal side; only one side of the paper is capable of showing the printout.
The paper should run under the roll before feeding through the roller.
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| Can I reprint the results on the QBC STAR? |
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Yes, as long as the tube is still in the instrument.
Press the "START" button.
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| Troubleshooting |
| What causes a "Sample Error 20" or "Buffy Coat Unreadable" errors? |
These errors are generally sample related.
Ensure that venous samples are well mixed prior to loading the QBC STAR Tube.
Invert the venous tube 12-15 times prior to loading the STAR Tube or 5 minutes on a mechanical rotator.
For capillary samples, proper collection technique is extremely important.
Warming the finger, using a blade lancet, wiping off the first drop of blood, and refraining from excessive squeezing of the collection area will yield a good sample.
Certain illnesses and disease processes may contribute to these errors as well.
If an illness or disease is thought to be the cause of the error, the patient should be tested via another method.
Call QBC Technical Support for any questions.
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| I am seeing discrepancies between the results on the QBC and the results from the reference lab. Why? |
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The results from two different CBC methodologies will rarely be exactly the same.
Confirm that the results are from the same sample.
If one set of results is from a capillary sample and the other set is from a venous sample, the results could vary significantly.
If the results vary between multiple capillary or multiple venous samples, it could be due to differences in the times of collections technique.
If the results are from the same venous sample, remix the venous tube at least 12-15 inversions prior to sampling.
Confirm that the test was performed within the acceptable time limit and that the venous sample was stored according to the manufactures recommendation.
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