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

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!

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.

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.

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

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

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

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

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

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%

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.

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

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

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

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

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

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

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!

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

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

… 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.

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.