qbc star poc haematology system faqs...locomotive house, locomotive industrial estate, horwich,...

Locomotive House, Locomotive Industrial Estate, Horwich, Bolton, Lancashire, BL6 5UE, UK.Tel: +44 (0)1204 460446 Fax: (0)1204 692198 Email: [email protected]

Web: www.woodleylabdiagnostics.com

QBC Star POC Haematology System FAQs

CLIAIs the QBC STAR considered CLIA waived?

Currently, all of the QBC Systems are moderately complex.

RegulationsIs the QBC STAR FDA approved?

Yes

Is the QBC STAR CE Marked?

Yes

Controls and DiagnosticsHow often do I have to run external controls on the QBC Star?

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.)

What is EQC (Equivalent Quality Control) Option 1?

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.

My controls arrived warm (ice packs were melted); can I still use the controls?

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 Woodley Laboratory Diagnostics Technical Support at +44(0)1204 460446.

Is there a QC program for the daily control tracking?

There is an Inter-Lab Quality Control (ILQC) program that can be ordered through Woodley Laboratory 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.

http://www.cms.hhs.gov/clia



Sample Collection and AnalysisWhat type of sample is required for QBC STAR testing?

Whole blood samples collected from either a capillary fingerstick or a venous blood draw (EDTA purple top tube).

How much blood is required to test on the QBC STAR?

The Star Tube requires 70µl of blood.

What tube types can be used with the QBC STAR?

The QBC STAR is designed to work only with the QBC STAR Tube.

What collection method should be used for the QBC STAR Tube?

The STAR Tube can be used with fingerstick or venous blood (EDTA tube).

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.

Can a sample be processed more than once on the QBC STAR?

Yes, once centrifuged the QBC STAR Tubes can be analysed 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 recognise that the tube has already been centrifuged and move directly to the scanning phase.

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.

Printing What external printers are compatible with the QBC Star?

Please contact Woodley Laboratory Diagnostics for the current recommendations.

What kind of paper can be used with the QBC STAR's internal printer?

The QBC STAR uses 2.25-inch thermal paper tape. Replacement rolls are available from Woodley Laboratory Diagnostics.

http://www.apexhealthware.com/



I just changed the paper on the STAR and now the printouts are blank.

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.

Can I reprint the results on the QBC STAR?

Yes, as long as the tube is still in the instrument. Press the "START" button.

TroubleshootingI am seeing discrepancies between the results on the QBC and the results from the reference lab. Why?

The results from two difference 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 manufacturer’s recommendation.

qbc star poc haematology system faqs...locomotive house, locomotive industrial estate, horwich,...

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