Previously QBC Diagnostics and the Drucker Company

The QBC STAR Dry Hematology Analyzer is a compact and easy to use complete blood count analyzer designed to bring CBCs to the point of care. With a 9-parameter complete blood count at the push of a button, the STAR makes on-site hematology easy and affordable

Part Number : 429001

How To Buy

QBC STAR Dry Hematology Analyzer

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QBC STAR: Features

The QBC STAR™ Dry Hematology System is the gold standard for performing CBC testing in a variety of settings, including office labs and even remote locations. The QBC STAR employs innovative dry hematology technology, meaning that all of the reagents needed to perform a CBC test with the QBC STAR System are contained in the QBC STAR Tube. After filling the tube with the blood sample, the clinician simply places it in the specially designed QBC STAR System and obtains the test results after the analysis is complete. This unique approach provides multiple benefits for in-office CBC testing:

 

Eliminating Liquid Reagents

Because the reagents needed for the STAR are contained within a single tube, there is no need for the liquid reagents associated with conventional CBC analyzers. This means no boxes of bulky reagents that take up needed lab space or complicated logistic and supply chain issues to deal with. Using the STAR's dry system also means that there is no need to dispose of dangerous biohazard reagent chemicals, making the STAR easier to use and more environmentally friendly than other analyzers on the market.

 

Size and Portability

The QBC STAR Dry Hematology System is extremely compact, measuring a small 16" x 16" for the entire self-contained unit and only weighs 19 lbs (8.6 kg). Because its reagent technology is contained within a single tube, the STAR is remarkably portable, and effective in many different testing environments. Installation time is less than 30 seconds, meaning the STAR is ready for use wherever and whenever needed.

 

Easy to Use

Unlike other hematology systems, the QBC STAR System is fully automated and so easy to operate that with minimal training, non-technical personnel can operate it. The operator simply inserts a STAR Tube into the machine, presses the START button, and walks away while the system performs a fully automated CBC analysis.

 

9-Count CBC

The QBC STAR measures nine important CBC hematological parameters from venous or capillary blood samples: hematocrit, hemoglobin, MCHC (mean corpuscular hemoglobin concentration), platelet count, white blood cell count, granulocyte count and percentage, and lymphocyte/monocyte count and percentage. Clinical trials have demonstrated that the accuracy and precision of the QBC STAR System correlate well to accepted standard methods.

STAR Tube


QBC STAR: Technology


The technology at the heart of the STAR is a process known as Quantitative Buffy Coat (QBC) analysis. This process, which gives QBC Diagnostics its name, is based on the physiological phenomenon in which the differing densities of blood components will cause them to separate into layers when centrifuged at a high rate of speed.


QBC tubes, including the QBC STAR tube, take advantage of this phenomenon in two ways. First, through the use of a small plastic float with the approximate density of platelets and white blood cells (the "buffy coat"), those usually small layers can be physically expanded for greater analysis. Second, stains coating the inside of the tubes stain lymphocytes and monocytes green, platelets yellow, and granulocytes orange, making the difference between layers visible, even to the naked eye.


The STAR combines this technology with its own advances to provide one-of-a-kind ease for the user. The STAR contains an internal centrifuge, which begins rotating the tube as soon as the start button is pushed. Once rotation is complete, the illumination/read station of the STAR utilizes an LED light source and optical detector to read the results of the test. Once complete, the STAR displays the results on the LCD screen, and automatically prints them on its internal thermal printer.


In addition to the technology used to provide test results, the STAR also includes many subsystems to improve the user experience.   The QBC STAR runs built-in analytical quality control checks every time a sample is processed to ensure accurate and effective results. Sample integrity checks include: statistical matching of band lengths, ratios and absolute values for signal levels, ratios that are used to evaluate the quality of interfaces, measurement of float length, verification of optics and sensors, measurement and evaluation of sample fill volume. Additional tests performed as part of each assay cycle include centrifuge speed and electro-optical verification. Results are reported on tube tests only if all analytical quality control checks pass. The STAR also contains data ports that can be used with additional printers, a keyboard, or a bar scanner to customize it for a user's individual needs.

Interested in learning more about the STAR? The following is an archive of currently available documents concerning the QBC STAR:

Product Literature

STAR BrochureBrochure
A full-color brochure describing the many features and benefits of the STAR technology.

Specification Sheet
A document containing all specifications for the QBC STAR, including number and operating range of parameters, precision, size, electrical specifications, environmental specifications, and more.

Product Description List
A list of all configurations and accessories currently available for the QBC STAR, including part numbers.

STAR Operators ManualOperator's Manual
The complete operator's manual for the QBC STAR.

CLIA Compliance ManualCLIA Compliance Assistance Manual
A comprehensive assistance manual intended to help you manage your office laboratory according to current laboratory quality standards. 

Expected Values
A handy reference guide for expected CBC values based on age and gender.

STAR Tube User Guide
An illustrated reference guide for using the QBC STAR Tube.
English | Español

Application Note: Dengue
This application note serves as a reference for how the QBC STAR can be used to manage Dengue cases.

Tech Tips: Collection Methods for Venous and Capillary Samples
This Tech Tip describes what type of sample should be used with the STAR Tube and the different collection methods available to fill the tube.

Tech Tips: What is Dry Hematology
A one page overview explaining the principle of dry hematology and the many benefits it offers.

Promotions

STAR 30 Day Evaluation Data SheetSTAR 30-Day Evaluation Datasheet
This document contains information about Drucker Diagnostics' free 30-Day STAR evaluation program.

STAR 30 Day Evaluation AgreementSTAR 30-Day Evaluation Agreement
This agreement is the official application for users interested in participating in the STAR 30-Day Evaluation Program, including the full terms and conditions of the program.

Scientific Studies

STAR vs. Sysmex K1000
Performance Comparison of the QBC STAR to the Sysmex K-1000 Impedance Analyzer and the Spun Microhematocrit.

Dry Hematology: its development, function, and role in point of care testing
A complete overview of the history and significance of dry hematology in the point of care laboratory.

Evaluation of the QBC STAR Centrifugal Hematology System
Comparison of the QBC STAR to the Sysmex XE-2100 Hematology Analyzer.

Quality Control

Levey-Jennings Charts
This document contains Levey-Jennings charts that can be used to record electronic quality control results from the QBC STAR.

MSDS

MSDS STARQBC STAR Tube 
A full-color Material Safety Data Sheet for the QBC STAR Tube.

Jump to a section:

CLIA

Controls and Diagnostics

Sample Collection and Analysis

Printing

Troubleshooting

CLIA

Is the QBC STAR considered CLIA waived?
Currently, all of the QBC Systems are moderately complex.

Controls and Diagnostics

How 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.

What is EQC (Equiavalent 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 QBC Technical Support at +1-866-265-1486 (U.S. only).

Is there a QC program for the daily control tracking?
Drucker Diagnostics also offers an online Inter-Lab Quality Control (ILQC) program to provide monthly peer comparisons with statistical evaluation of your results. To access this program, please click here.

Sample Collection and Analysis

What parameters does the QBC STAR report?
The STAR provides a 9 parameter CBC with 2 part differential.

  • Hematocrit (Hct)
  • Mean Corpuscular Concentration (MCHC)
  • White Blood Cell Count (WBC)
  • Granulocyte Count (Gran #)
  • Granulocyte % (Gran %)
  • Lymphocyte and Monocyte Count (Lymph/Mono #)
  • Lymphocyte and Monocyte % (Lymph/Mono %)
  • Platelet Count (Plt)

What type of sample is required for QBC STAR testing?

Whole blood samples collected from a capillary fingerstick, capillary heel stick, 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.

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 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.

Is the QBC STAR compatible with electronic record keeping systems?
Yes, The QBC STAR is compatible with such systems. It is recommended that you contact a third party integrator for assistance with connecting the STAR to your system (see next question).

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?
The HP Officejet 6100 has been tested and found to be compatible with the 2012 STAR. Please contact Drucker Diagnostics for the latest list of compatible printers.

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 Drucker Diagnostics

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.

Troubleshooting

I am seeing discrepancies between the results on the QBC and the results from the reference lab. Why?
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 manufacturer's recommendation.

General

What CPT Code is used for reimbursement of tests run on the QBC STAR?
The CPT Code for the QBC STAR is 85025, CBC with differential.

What is the cost per test to run the QBC STAR?
Because of the STAR’s unique dry hematology method, the cost per test is much easier to identify than wet hematology systems that have hidden operational and service costs. The only disposables used by the STAR are the QBC STAR tubes and CLIA required hematology controls. For an estimate of the cost to operate the QBC STAR please visit the Economics tab.

Is their a local representative who can give a demonstration of the QBC STAR?
We work primarily through distribution channels and have partners throughout the U.S. and around the world who supply and support the QBC STAR. To find a distributor near you, please visit our How To Buy page.

Interested in the financial benefits of the STAR? This financial calculator can help you to determine the monthly profit you will derive from using the STAR system, as well as a break even calculation.

Expected Return on Investment (ROI) Calculator

Cost Information

  • QBC STAR Dry Hematology Analyzer

QBC STAR: Service

For all service inquiries, please contact the Drucker Diagnostics Technical Service Department at +1-866-265-1486 (U.S. only) or support@druckerdiagnostics.com. Our Technical Support Representatives are available Monday - Friday, 8:30 a.m. - 5:00 p.m. (EST).

Otherwise, contact your nearest Drucker Diagnostics office for assistance. To locate a service center near you, please click here.

Limited Warranty

All STAR systems come with a 12-month limited warranty from the date of original shipment from Drucker Diagnostics. In the unlikely event that a STAR system needs repair due to defects in materials and workmanship, the warranty covers all parts and labor needed to repair the STAR at no cost to the user. Please consult Appendix A of the QBC STAR Operator's Manual for more details on the terms of the warranty.

Troubleshooting

The QBC STAR contains no user replaceable parts. If the instrument fails to operate properly, DO NOT ATTEMPT TO PERFORM ANY SERVICE OR REPAIR, unless specifically listed below. Refer service problems to the Technical Service Department of Drucker Diagnostics at +1-866-265-1486 (U.S. only) or support@druckerdiagnostics.com. Our Technical Support Representatives are available Monday - Friday, 8:30 a.m. - 5:00 p.m. (EST). Otherwise, contact your nearest Drucker Diagnostics office for assistance.

In some instances, a customer can perform minor corrective actions to fix smaller problems with the STAR. Consult the following guide for information on these specific instances:

Symptom Possible Causes Corrective Actions
Instrument fails to operate Power cord not plugged into unit or receptacle Plug cord into unit and receptacle.
Door not latched Close door and latch securely.
Line fuse blown Replace fuse(s) by following instructions in Section 5 of the QBC STAR Operator's Manual
Instrument vibrates excessively Foam pads worn or missing on bottom of instrument Request authorized service.
Lid fails to open Power has failed Use emergency door unlock procedure in Section 4 of the QBC STAR Operator's Manual.
Defective lid solenoid or internal parts Request authorized service.

QBC STAR: Training

QBC Diagnostics offers on-site training to most STAR customers. In almost all cases, the cost of training is included as part of the purchase price of the STAR. Retraining is also available for existing customers for a small fee. For more information, please contact our sales department at sales@druckerdiagnostics.com.

Drucker Diagnostics has also developed the following series of videos that walk users through the basics of using the STAR system:

STAR Installation
QBC STAR Setup and Installation

This video walks the user through the STAR's features, system setup, and the system's components.



QBC STAR Tube

QBC STAR Tube
This video introduces the user to the unique design of the QBC STAR tube which is the only disposable used in the QBC STAR System.


Capillary Sample Collection

QBC STAR Capillary Sample Collection

This video demonstrates proper collection and mixing techniques essential for a successful capillary sample.


Venous Sample Collection

QBC STAR Venous Sample Collection
This video demonstrates proper collection and mixing techniques when using a lavender-top collection tube for a venous blood sample.


QBC STAR Operating and Results

QBC STAR Operating and Results
This video illustrates how to use the STAR including: prompt screens, keyboard use, and printing copies. It also details the results generated by the STAR.

Click the following sections for more information on CLIA requirements for the QBC STAR Dry hematology analyzer:

What is CLIA?

Quality Requirements for Moderately Complex Tests

Written Procedure Manual

Proficiency Testing

Personnel Training and Evaluation

Laboratory Director

Other Positions

Quality Assessment

Internal Quality Checks

External Quality Checks

CLIA Inspections

Application for CLIA Certification

What is CLIA?

CLIA is an acronym for Clinical Laboratory Improvement Amendments. It sets forth uniform quality standards for laboratories and applies to all entities that perform tests for health purposes on human specimens. CLIA requirements are based on the complexity of tests performed (waived, moderate, or high).

QBC hematology systems, such as the QBC STAR, are considered moderate complexity test systems, and therefore must meet quality requirements for moderately complex testing.

Quality Requirements for Moderately Complex Tests

Written Procedure Manual

A procedure manual is a detailed sequence of activities showing how the test procedure is to be performed. It breaks down the test procedure one step at a time. You may utilize the QBC STAR Operator's Manual as your procedure manual if it is your policy to do so. Please ensure personnel are informed that they must follow the procedure as stated in the Operator's manual for performing the test. The procedure must be approved and signed by the Laboratory Director.

Proficiency Testing

CLIA requires that you participate in a Proficiency Test Program. These programs monitor the performance of your test system. Participants will receive five unknown samples, three times per year. Samples are to be treated in the same manner as patient specimens. The results are evaluated and comparisons made to other laboratories within your Peer group; laboratories using the same analyzer and tube type. Below is a listing of Proficiency Test Providers and a chart percentage of QBC participants submitting results according to each provider.

American Proficiency Institute (API)
800-333-0958 www.api-pt.com

American Academy of Family Physician's (AAFP)
800-274-2237 www.aafp.org

American College of Physicians (PT division-Medical Laboratory Evaluation-MLE)
800-338-2746 www.acponline.org

College of American Pathologists (CAP)
800-323-4040 www.cap.org

American Association of BioAnalysts (AAB)
800-234-5615 www.aab.org

Personnel Training and Evaluation

For a link to CLIA personnel qualifications: www.cms.hhs.gov/cmsforms/downloads/cms209.pdf

Laboratory Director

CLIA specifies that a physician (MD or DO) serving as Laboratory Director must have at least one year experience supervising moderately complex testing OR complete a 20 credit course. This course can be completed on-line at www.medicine.uiowa.edu/cme/clia/ orwww.cola.org/labu.html. The Lab Director can also attend a 2.5 day workshop provided by COLA (www.cola.org for dates and times).

Additionally, individuals with a Bachelor's degree and 2 years laboratory experience PLUS 2 years supervisory experience, or a Master's degree and 1 year experience PLUS 1 year supervisory experience also qualify to direct a moderately complex laboratory.

Other Positions

Moderately complex laboratories also have three other positions specified by CLIA:
  1. Clinical Consultant (Qualified Laboratory Director)
  2. Technical Consultant (Qualified Laboratory Director)
  3. Testing analyst (high school diploma and documented training)
* a single person may fill the position of Lab Director, Clinical, and Technical Consultant.

Quality Assessment

CLIA requires that the following quality standards be tested and documented on moderately complex systems:
  1. Specimen ID and Integrity
  2. Patient Confidentiality
  3. Personnel competency assessment
  4. Proficiency Testing
  5. Test requesting
One means of testing these quality standards is through the use of internal and external quality checks, as appropriate.

Internal Quality Checks

The QBC STAR automatically performs internal quality testing whenever it is turned on, or every eight hours if left on continuously.

External Quality Checks

Liquid controls are available for the QBC STAR through Drucker Diagnostics. Traditional quality controls consists of running at least two levels of external control material each day of patient testing.

Drucker Diagnostics also offers an online Inter-Lab Quality Control (ILQC) program to provide monthly peer comparisons with statistical evaluation of your results.To access this program, please click here.

CLIA Inspections

CLIA requires inspections every two years. The inspections are non-punitive unless there if a failure to correct deficiencies.

Laboratories may also choose another CLIA approved accrediting agency, including COLA (www.cola.org), CAP (www.cap.org), or JCAHO (www.jcaho.org) to conduct the inspections. These organizations will assist you in preparing your laboratory for inspection, including support and training. Fees vary, so please visit each individual site for further information on the services they provide.

Application for CLIA Certification

To apply for CLIA certification or to change Certificate Type, please consult the following website:www.cms.hhs.gov/cmsforms/downloads/cms116.pdf

Please note that your completed CLIA application should be forwarded to the address of the local State Agency for the state in which your laboratory resides. You should also contact this State Agency for additional forms that may be necessary to complete the registration process. For a listing of contact information by state, please go to the following website: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

States Requiring certification:

CA, CT, FL, HI, ID, MD, NV, PA, and WA

QBC STAR: Testimonials

QBC systems have been in use globally for over 25 years with active installations on every continent, including Antarctica. There are over 15,000 active QBC hematology systems installed worldwide. If you would like references for any of our innovative solutions from users near you, please contact us.


"We decided to make the change (to the QBC STAR) in January of 2009 and have been very pleased with its performance. Very little training was needed to teach our personnel how to properly use the machine. Additionally, we have had to perform much less routine maintenance on this instrument and there are no daily wet controls."

Scott T. Burger, D.O., Chief Medical Officer, Doctors Express
www.doctorsexpress.com


"I teach Clinical Hematology in the Medical Laboratory Science program at The Ohio State University. For the first time this year, I had the QBC STAR instrument in my laboratory to train students in performing the CBC. The instrument is outstanding: reliable, accurate, easy to use and requires little or no service. In fact, results agreed very closely with the instrument at the medical center, that uses a different methodology. It was delightful to watch the students' faces light up as they read their CBC results for the first time. I highly recommend this instrument for student laboratories as well as for physician offices and clinics. "

Kathy V. Waller, PhD, MLS
Associate Professor
Medical Laboratory Science Division
The Ohio State University