1. Boule Medical AB Quality Control – a profitable business Kenneth Wikner, International Product Manager

2. Quality Control – a profitable business
Every hematology system needs quality control
So does your business
Boule QC products help you sell more to existing customers
Remember – it’s five to ten times more expensive to acquire a new customer then retain an existing one
Some distributors increase their after sales revenue by up to 50%!
No hematology testing system is complete without quality control!

3. Growing market for hematology QC
Many regulators now require clinical laboratories to conduct QC programs
QC ensures the quality of CBC testing
QC can be a requirement for reimbursement
More labs want to offer clients ‘Quality-controlled hematology results’
Boule Medical is one of few producers in the world of hematology controls.

4. Boule QC materials Boule Cal (calibrator) Boule Con Diff (control)
For measuring and adjusting systematic error (bias)
Helps instruments work more accurately
Boule Con Diff (control)
Addresses random and systematic errors
Confirms that the instrument is stable and precise
Both help analyzers generate reportable blood measurement results.

5. Part of our Total Quality Concept (TQC)
A complete hematology system comprises an instrument, reagents and QC materials, plus service and support. You can offer:
Instrument, reagents, QC and service – all from the same supplier!
An unbroken chain of know-how in quality hematology measurements

6. QC sales boost your hematology business
CBC is already the world’s most common diagnostic test
The market potential of Boule hematology controls is clear
We can help you:
Increase your sales revenue
Reduce your running costs
Gain a competitive advantage

7. Increase your sales revenue
When regulations demand QC as a requirement for reimbursement, quickly introduce testing laboratories to Boule QC products
Immediately generates more sales income
When non-regulated private testing laboratories want a strong USP, supply them with Boule QC products that offer ‘Quality-controlled hematology results’
Increases sales and strengthens customer relationships

8. Reduce your running costs
When hematology testing is ‘all inclusive’, include just one (or more) control per day and add planned follow-up to the leasing contract
More cost effective than emergency service visits
Boosts your image as a quality distributor

9. Gain a competitive advantage
Opportunities for new marketing activities, e.g. ‘Monthly control-check’
Your service/sales staff visit end-users and analyze their controls
Strengthens your quality image
Increases the number of customer contacts
Raises QC awareness at customer sites

10. Selected success stories
Regions where QC has become an important revenue source. 
Sweden – a typical end-user runs approx. 20 samples plus one control/day. But 50% of after-sales revenue is from the control materials!
Southern Europe – a three-level control/day is mandatory, otherwise no reimbursement will be paid out
South Asia – stabile sales relation between controls and reagents. Shows that controls are sold to each new instrument placement
Middle-East – control revenue increased from 30% of total after-sales revenue to almost 50%

11. Brief background to QC – definitions
Quality assurance (QA) and quality control (QC) have different meanings.
QA is planned, systematic activities implemented in a quality system to fulfill the quality requirements for a product or service
QC is observation techniques and activities used to fulfill the quality requirements
QC plays a vitally important role in a hematology system.

12. QC – more definitions Calibration
Adjusting instruments to eliminate bias
Control
Ensuring that instruments are correctly calibrated
Calibration and Control are two very important procedures.

13. Systematic vs. random errors
Accuracy = How close the results are to the true (accepted) value
Precision = Reproducibility of results
Neither accurate nor precise

14. Precision/accuracy vs. type of error
Accurate and precise – no systematic or random error
Precise but not accurate – bias indicates systematic error
Neither accurate nor precise – bias indicates systematic error and individual deviation can also be seen

15. QC – role of Boule materials
Ensure that a CBC instrument performs as planned
Over its operating range with expected precision and linearity
Biases remain within a pre-selected range or control range
Calibration and control are key parts of the internal QC process
Calibration (Boule Cal) – measuring and adjusting systematic error (bias)
Control (Boule Con Diff) – addresses random and systematic errors

16. When to use Boule Cal Example recommendations:
When a hematology analyzer is first installed in an end-user lab
After major preventive maintenance or replacement of critical parts
After yearly service
After major instrument repair
When results from control materials indicate an unusual trend or shift of analyzer performance, e.g. baseline drift

17. When to use Boule Con Diff
Example recommendations:
Every day as a routine QC procedure (frequency should reflect workload)
At the start and end of a day’s work
When the analyzer is restarted after complete shut-down
When changing reagents between lots or within the same manufacturing lot
When an unexpected abnormal patient result is reported

18. Benefits of QC testing
Addresses and eliminates errors before samples are run
Ensures that cell counters operate within their set precision and linearity
Keeps biases within a pre-selected range or control range
Eliminates human factor errors (thanks to barcode scanning)
Helps hematology analyzers generate reportable blood measurement results
Avoids costly, time-consuming re-testing!

19. Sales challenges and opportunities (1)
Challenge: Calibrator and Control runs are expensive
Response: QC materials are usually more expensive than other consumables, but …
Boule Medical AB is one of the very few companies that can today produce quality-assured hematology QC materials
We can help end-users reduce their total QC costs
Daily controls do increase the cost, but …
Only by 0.1 USD/sample (calculated 30 samples/day)
They also add value since they deliver a quality-assured hematology result

20. Sales challenges and opportunities (2)
Challenge: Customer laboratories do not recognise the importance of QC
Response: Awareness is growing fast
More and more regulations require clinical labs to conduct a QC program
We will help promote QC materials and the importance of QC testing to end-user labs

21. … and remember
Users enter all Boule QC reference values via a barcode scanner.
This alone eliminates human entry error – one of the most common reasons for QC problems in hematology testing, e.g. …
The expiry date of the control has passed
Incorrect control ranges have been entered in the system, etc., etc.

22. Boule QC materials – summary
Two QC products – Boule Cal and Boule Con Diff
Part of our Total Quality Concept
Demand and market potential for QC is growing
No hematology testing system is complete without it
Selling Quality Control is a profitable business!
Don’t hesitate to contact Boule Medical for further information.