POCT INR glucose EQALM 2005 sendt

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Information about POCT INR glucose EQALM 2005 sendt
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Published on October 29, 2007

Author: Nastasia

Source: authorstream.com

Slide1:  POCT EQA for coagulation and glucose on the level of physicians and patients - is it possible? Sverre Sandberg Norwegian Quality Improvement of Primary Care Laboratories (NOKLUS) and Lab. Clin. Biochem. Haukeland University Hospital and NOKLUS, Bergen, Norway EQALM Rome, 2005 Similar “problems” with POC EQAS for PT-INR and Glucose:  Similar “problems” with POC EQAS for PT-INR and Glucose Control material A lot of different instruments using whole blood Lot to lot variation SO Why are we doing EQAS? Are we doing more good than harm? Should we extend to P-EQAS? EQAS for office laboratories and hospital laboratories - what is the difference:  EQAS for office laboratories and hospital laboratories - what is the difference EQAS for Primary health care General Practitioners Office personell, Nurses NOKLUS - some numbers - 2004:  NOKLUS - some numbers - 2004 2200 participants from PHC (99.7%), 86 hospital labs About 5000 physicians 1288 visits in PHC by lab.consultants 140 courses with 3627 participants And what about you?:  And what about you? Do physicians in your home country analyse prothrombin time in their offices? Do you have an EQA system for this Do patients in your home country analyse prothrombin time? Do you have an EQA system for this? Prothrombin time (PT-INR):  Prothrombin time (PT-INR) How can POC EQAS be carried out for PT-INR? Control material Split sample or traditional EQA? Physicians offices and patients Quality specifications Post-analytical EQA Van der Besselaar. J.Thromb. Thrombolysis. 2001;12:35-40:  Van der Besselaar. J.Thromb. Thrombolysis. 2001;12:35-40 Quality control (QC) materials for POC devices are different from patients’ samples and may not exactly reflect the real clinical situation. Nevertheless, internal and external QC schemes for POC devices are valuable to investigate their performance in daily practice. Calibration can be improved by direct comparison of a POC system against an established international reference preparation method. Number of participants with different instruments:  Number of participants with different instruments Control material are we assessing the right things right?:  Control material are we assessing the right things right? Different types of instrument use different control materials patient like material is difficult fresh / frozen plasma not possible. lyophilized, dissolved material? Slide10:  Thrombotest: Lot to lot variation (99% CI) Split sample compared to traditional EQA:  Split sample compared to traditional EQA Traditional EQA is influenced by Control material /dilution / dissolution Analytical procedure Advantage: Few variables, same level and easy to compare Disadvantage: Control material, and the whole procedure is not taken into account Split sample compared to traditional EQA:  Split sample compared to traditional EQA Split sample is influenced by Sampling procedure* Analytical procedure Sending procedure* Conventional reference method procedure* Advantage: Native material, whole procedure taken into account Disadvantage: Many variables, different levels, less easy to organise. TO BE ABLE TO COMPARE:  TO BE ABLE TO COMPARE QUALITY SPECIFICATIONS HAVE TO EXPANDED FROM THE CONVENTIONAL EQA METHOD TAKING THE VARIANCE IN BLOOD SAMPLING, SENDING AND CONVENTIONAL REFERENCE METHOD INTO ACCOUNT Patient self -testing Coagucheck:  Patient self -testing Coagucheck Tripodi et al.Thrombosis Research 2004; 111: 35-40 Patient self-testing: Difference between ProTime and laboratory INR vs laboratory INR. :  Patient self-testing: Difference between ProTime and laboratory INR vs laboratory INR. Sunderji et al. Am. J. Clin Pathol 2005;124: 184-8 WHAT shall we look for? :  WHAT shall we look for? Only analytical quality? OR ALSO How tests are interpreted? Cartoon by courtesy of Amanda Burls Slide17:  Clinical Findings Interpretation Test requesting Pre-analytical phase Analysing Test report Diagnosing Monitoring Slide18:  External quality assessment programmes should, as far as possible provide clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre- ad post-examination procedures Glucose:  Glucose And what about you?:  And what about you? Do physicians in your home country analyse glucose in their offices? Do you have an EQA system for this? Do patients in your home country analyse glucose? Do you have an EQA system for this? Problems - glucose Evaluation of participant or evaluation of instrument?:  Problems - glucose Evaluation of participant or evaluation of instrument? Native material is not possible / difficult Target values from reference methods can not be used - i.e. method-specific target values are usually used Lot to lot variation What is a method specific target value? :  Kristensen et al Clin Chem 2005; 51: 1632-6 What is a method specific target value? What is a method specific target?:  What is a method specific target? The median after exclusion of outlier results? The median after exclusion of some of the lots? The median after exclusion of outliers for each lot? What are we evaluating?:  What are we evaluating? The participants? - then ideally there should be a lot specific target. With a method specific target, we are evaluating both lot to lot variation as well as participant performance Consequences::  Consequences: Do differences found between lots using the control material also reflect differences between lots when native material is used? :  Do differences found between lots using the control material also reflect differences between lots when native material is used? Do the lot to lot differences reflect results when capillary blood is used? :  Kristensen et al Clin Chem 2005; 51: 1632-6 Do the lot to lot differences reflect results when capillary blood is used? Slide30:  Kristensen et al Clin Chem 2005; 51: 1632-6 Slide31:  Case stories distributed in: Hungary Norway Sweden The Netherlands Australia Spain South-Africa Slide32:  A 64-year-old man, somewhat overweight. He tells you that his mother had diabetes when she was “well on in years”. He himself feels fit, but he would like to have his blood sugar measured. Thus, he has had the foresight to come fasting to this morning consultation. He has never been seriously ill previously and he takes no regular medication. Blood pressure is measured to 160/90 and there is no other pathological findings on clinical examination. His fasting blood glucose is measured to 5.8 mmol/L (capillary). Slide33:  If his fasting blood glucose was measured again a few days later at your practice: How low would that value need to be before you would believe that his actual blood glucose was lower than when measured previously? __,__ mmol/L How high would that value need to be before you would believe that his actual blood glucose was higher than when measured previously? __,__ mmol/L Calculations:  Calculations Feedback report to the participants:  Feedback report to the participants Information on Own results compared to others Corresponding analytical quality Information on analytical and biological variation Guidelines for use of the actual laboratory tests Next will be microalbumine:  Next will be microalbumine Questionnaire to diabetic patients:  Questionnaire to diabetic patients Imagine that you have measured your blood glucose level to be 8.0 mmol/L To what value do you think your blood glucose must increase before you would be sure that it represents a true increase? ___ Conclusions:  Conclusions Instruments for selfmonitoring of blood glucose must have a CVa < 5% and a bias of < 5% in the hands of the diabetic patients; i.e. A TE < 13%. Clin Chem 2001; 47: 67-73 Slide41:  Glucose (mmol/L) Clin Chem 2002; 48: 994-1003 How should patients control their performance and the instruments?:  How should patients control their performance and the instruments? User assessment at the physicians office? User assessment at the pharmacy? External quality control? Slide43:  Thank you

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