12th March 2003

Dear Sir,

This is reference to your letter of 12th March regarding the Celly Heamatology Analyzer.

Thank you for bringing your concerns directly to our notice, facilitating us to address the following two issues separately.

1. Unsatisfactory level of After Sales Service with regard promptness in attending to your Machine.

2. Inaccuracy of the Test Results.

Unsatisfactory level of After Sales Service with regard promptness in attending to your Machine.

Please let me apologize on behalf on my Staff for the poor quality of service. We shall ensure to prevent a similar occurrence in future. We appreciate your valued time spent to send this letter to our attention. Apparently my staff has visited your laboratory and attended to the machine but not brought it to the notice of the management.

Inaccuracy of the test results.

The accuracy of the Test Results of a Instrument can be proved only with the Quality Control material used. The Quality Control material are internationally accredited Samples for which values are defined and predetermined for the Parameters to be tested. The only method of proving the accuracy of Instrument is by running such Samples and obtaining the pre-determined results on the Machine accurately. The precision of the Instrument can be proven only if these results are repeated and if accuracy is maintained with + 2% variation.

Please find attached the Protocol for a Heamatology Department which should be followed to guarantee the accuracy of Samples. We have carried out Quality Control material at the cost to our company on 13/12/2002. The results received are as per attached. It has been recommend that these QC tests are repeated as a daily routine protocol.

Yours faithfully,

ANALYTICAL INSTRUMENTS (PVT) LTD

A. Amarasuriya

Director

/g

Attachment 1

Western infirmary LISA 300

General Guide Lines

POSSIBILITY'S OF GETTING THESE ERRORS

1.contaminated sample container.

2.wrong anti coagulant

3.wrong sample labeling and storage.

4.sample transportation? Temperature

5.Sample loading to the analyzer.

Recommendations

Should follow W.H.O good laboratory practice protocols.

TEST PROCEDURE

1. Switch on the Instrument.

2. Auto cleaning and priming.

3. Take out reagents, QC and calibrators from the refrigerator.

4. Leave 15 minute at normal room temperature.

5. Check the date of expiry and reconstitute shelf life.

6. If reagents, calibrators and QC are expired, reconstitute new vials and marked the date on the label.

7. Load the Reagent into the correct reagent segment and the position.

8. Load the QC sample in to the correct position.

9. Analyze the QC 1st.

10. Take the printout from the analyzer.

11. Compare the results with the Qc charts.

12. Record the QC results on form A.

13. If QC results tally's with QC results charts should get the signature of the laboratory manager.

14. If QC results not tally's with QC results record the QC result on format A.

15. Recalibrate the Instrument with MULTI POINT CALIBRATOR or chemical standard with a control(QC).

16. Take the printout of calibration curve and control (QC) curves and report on form A and B

17. If still QC result not tally's with QC charts

(a) Reconstitute a new reagent vial.

(b) Use a new CALIBRATOR

(C) Reconstitute a new QC vial

(d) Use new reagent borts and samples cups
(e) Run a auto wash cycle.
record these steps on form B
18. And recalibrate the Instrument and run a control (QC)
check control values with QC chart. Record the results on form A. if still QC results are not correct contact the instrument supplier.

19. If QC is ok, should Get Laboratory manager's signature and approval for form A and B to analyze patients samples

20. Load the QC and patient samples into the right segment and right position and analyze QC patient sample in triplicate. Record correct results. (mean)
