Recommendations for Setting a Criterion and Assessing Commutability of Sample Materials Used in External Quality Assessment/Proficiency Testing Schemes.

It is important for external quality assessment materials (EQAMs) to be commutable with clinical samples; i.e., they should behave like clinical samples when measured using end-user clinical laboratory in vitro diagnostic medical devices (IVD-MDs). Using commutable EQAMs makes it possible to evaluate metrological traceability and/or equivalence of results between IVD-MDs. The criterion for assessing commutability of an EQAM between 2 IVD-MDs is that its result should be within the prediction interval limits based on the statistical distribution of the clinical sample results from the 2 IVD-MDs being compared. The width of the prediction interval is, among other things, dependent on the analytical performance characteristics of the IVD-MDs. A presupposition for using this criterion is that the differences in nonselectivity between the 2 IVD-MDs being compared are acceptable. An acceptable difference in nonselectivity should be small relative to the analytical performance specifications used in the external quality assessment scheme. The acceptable difference in nonselectivity is used to modify the prediction interval criterion for commutability assessment. The present report provides recommendations on how to establish a criterion for acceptable commutability for EQAMS, establish the difference in nonselectivity that can be accepted between IVD-MDs, and perform a commutability assessment. The report also contains examples for performing a commutability assessment of EQAMs.

Feasibility for aggregation of commutable external quality assessment results to evaluate metrological traceability and agreement among results.

Objectives: External quality assessment (EQA) with commutable samples is used for assessing agreement of results for patients' samples. We investigated the feasibility to aggregate results from four different EQA schemes to determine the bias between different measurement procedures and a reference target value. Methods: We aggregated EQA results for creatinine from programs that used commutable EQA material by calculating the relative difference between individual participant results and the reference target value for each sample. The means and standard errors of the means were calculated for the relative differences. Results were partitioned by methods, manufacturers and instrument platforms to evaluate the biases for the measurement procedures. Results: Data aggregated for enzymatic methods had biases that varied from -8.2 to 3.8% among seven instrument platforms for creatinine at normal concentrations (61-85 µmol/L). EQA schemes differed in the evidence provided about the commutability of their samples, and in the amount of detail collected from participants regarding the measurement procedures which limited the ability to sub-divide aggregated data by instrument platforms and models. Conclusions: EQA data could be aggregated from four different programs using different commutable samples to determine bias among different measurement procedures. Criteria for commutability for EQA samples as well as standardization of reporting the measurement methods, reagents, instrument platforms and models used by participants are needed to improve the ability to aggregate the results for optimal assessment of performance of measurement procedures. Aggregating data from a larger number of EQA schemes is feasible to assess trueness on a global scale.

Ethnic and gender differences in the management of type 2 diabetes: a cross-sectional study from Norwegian general practice.

BACKGROUND: Ethnic minority groups from Asia and Africa living in Western countries have a higher prevalence of type 2 diabetes (T2DM) than the general population. We aimed to assess ethnic differences in diabetes care by gender. METHODS: Population-based, cross-sectional study identified 10,161 individuals with T2DM cared for by 282 General Practitioners (GP) in Norway. Ethnicity was based on country of birth. Multilevel regression models adjusted for individual and GP factors were applied to evaluate ethnic differences by gender. RESULTS: Diabetes was diagnosed at a younger mean age in all other ethnic groups compared with Westerners (men: 45.9-51.6 years vs. 56.4 years, women: 44.9-53.8 years vs. 59.1 years). Among Westerners mean age at diagnosis was 2.7 years higher in women compared with men, while no gender difference in age at diagnosis was found in any minority group. Daily smoking was most common among Eastern European, South Asian and Middle East/North African men. In both genders, we found no ethnic differences in processes of care (GPs' measurement of HbA1c, blood pressure, LDL-cholesterol, creatinine). The proportion who achieved the HbA1c treatment target was higher in Westerners (men: 62.3%; women: 66.1%), than in ethnic minorities (men 48.2%; women 53.5%). Compared with Western men, the odds ratio (OR) for achieving the target was 0.45 (95% CI 0.27 to 0.73) in Eastern European; 0.67 (0.51 to 0.87) in South Asian and 0.62 (0.43 to 0.88) in Middle Eastern/North African men. Compared with Western women, OR was 0.49 (0.28 to 0.87) in Eastern European and 0.64 (0.47 to 0.86) South Asian women. Compared with Westerners, the blood pressure target was more often achieved in South Asians and Middle Easterners/North Africans in both genders. Small ethnic differences in achieving the LDL-cholesterol treatment target by gender were found. CONCLUSION: Diabetes was diagnosed at a considerably earlier age in both minority men and minority women compared with Westerners. Several minority groups had worse glycaemic control compared with Westerners in both genders, which implies that it is necessary to improve glucose lowering treatment for the minority groups. Smoking cessation advice should particularly be offered to men in most minority groups.

Biological variation data for lipid cardiovascular risk assessment biomarkers. A systematic review applying the biological variation data critical appraisal checklist (BIVAC).

BACKGROUND: Biological variation (BV) data can be used to set analytical performance specifications (APS) for lipid assays. Poor performance will impact upon the efficacy of international guidelines for cardiovascular risk assessment (CVR) and relevant clinical decision limits. This systematic review applies the Biological Variation Data Critical Appraisal Checklist (BIVAC) to published studies of BV of CVR biomarkers enabling metanalysis of the data. METHODS: Studies of BV of total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and apolipoproteins A1 and B, retrieved using a systematic literature search, were evaluated and graded using the BIVAC. Meta-analysis of CVI and CVG estimates were performed utilizing weightings based upon BIVAC grades and the width of the data confidence intervals. RESULTS: Applying the BIVAC, ten publications were graded as D, 43 as C, 5 as B and 1 as A (fully compliant). A total of 196 CVI and 87 CVG estimates were available for the different lipid measurands. The meta-analysis-derived BV data estimates were generally concordant with those in the online 2014 BV database. CONCLUSIONS: Application of BIVAC identifies BV data suitable for many important applications including setting APS. Additionally, this review identifies a need for new BIVAC compliant studies to deliver BV reference data in different subpopulations.

Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing.

BACKGROUND: The optimal situation in external quality assessment (EQA) is to use commutable materials. No previous study has examined the commutability of a whole-blood material for point-of-care (POC) testing. The aim of this study was to determine the commutability of the Norwegian Quality Improvement of Laboratory Examinations (Noklus) organization's "in-house" whole-blood EQA material for C-reactive protein (CRP), glucose, and hemoglobin for frequently used POC instruments in Norway and to determine the possibility of using a common target value for each analyte. METHODS: The study was performed according to the Clinical and Laboratory Standards Institute guidelines. The EQA material was pooled stabilized EDTA venous whole-blood containing different concentrations of the analytes. The EQA material and native routine patient samples were analyzed using 17 POC and 3 hospital instruments. The commutability was assessed using Deming regression analysis with 95% prediction intervals for each instrument comparison. RESULTS: The EQA material was commutable for all CRP and hemoglobin POC instruments, whereas for glucose the material was commutable for all POC instruments at the lowest concentration analyzed [126.0 mg/dL (7.0 mmol/L)] and for 3 POC instruments at all of the concentrations analyzed. CONCLUSIONS: Noklus EQA participants using CRP and hemoglobin POC instruments now receive results that are compared with a reference target value, whereas the results for participants using glucose POC instruments are still compared with method-specific target values. Systematic deviations from a reference target value for the commutable glucose POC instruments can be calculated, and this additional information can now be offered to these participants and to the manufacturers.

Risk assessment and HbA1c measurement in Norwegian community pharmacies to identify people with undiagnosed type 2 diabetes - A feasibility study.

OBJECTIVES: Determine the feasibility of using a diabetes risk assessment tool followed by HbA1c-measurement in a community-pharmacy setting in Norway. METHODS: In this longitudinal study two pharmacists in each of three community pharmacies were trained to perform risk assessments, HbA1c-measurements and counselling. Pharmacy customers who were > 18 years old and could understand and speak Norwegian or English were recruited in the pharmacies during a two-months-period. Information about the service was presented in local newspapers, social media, leaflets and posters at the pharmacy. Customers wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. A HbA1c measurement was performed for individuals with a moderate to high risk of developing diabetes. If HbA1c ≥ 6.5% they were recommended to visit their general practitioner for follow-up. The pharmacies performed internal and external quality control of the HbA1c instrument. RESULTS: Of the 211 included participants 97 (46%) were > 50 years old. HbA1c was measured for the 47 participants (22%) with high risk. Thirty-two (15%) had HbA1c values < 5.7%, twelve (5.4%) had values between 5.7%-6.4%, and three (1.4%) had an HbA1c ≥ 6.5%. Two participants with HbA1 ≥ 6.5% were diagnosed with diabetes by their general practitioner. The third was lost to follow-up. Results from internal and external quality control for HbA1c were within set limits. CONCLUSION: The pharmacists were able to perform the risk assessment and measurement of HbA1c, and pharmacy customers were willing to participate. The HbA1c measurements fulfilled the requirements for analytical quality. Thus, it is feasible to implement this service in community pharmacies in Norway. In a large-scale study the inclusion criteria should be increased to 45 years in accordance with the population the risk test has been validated for.

Intensive educational efforts combined with external quality assessment improve the preanalytical phase in general practitioner offices and nursing homes.

BACKGROUND: Errors in the preanalytical phase in clinical laboratories affect patient safety. The aim of this study was to evaluate the effect of intensive educational efforts together with external quality assessment (EQA) of the preanalytical phase from 2013 to 2015 to improve patient identification in primary health care in Norway. In addition, routines for venous and capillary blood sampling were investigated. METHODS: A preanalytical EQA was circulated in 2013 by the Norwegian Quality Improvement of Laboratory Examinations (Noklus) to general practitioner offices and nursing homes (n=2000) to obtain information about important issues to focus on before launching an intensive educational program with courses, posters and visits in 2013-2015. Preanalytical EQA surveys were further circulated in 2014 and 2015. RESULTS: The response rate varied between 42% and 55%. The percentages of participants asking for the patients' name and the Norwegian identification number increased from about 8% in 2013 to about 35% in 2015. The increase was similar for those participating in only one EQA survey and for those who participated in EQA surveys both in 2013 and 2015. Guidelines for venous and capillary blood sampling were not always followed. CONCLUSIONS: Educational efforts more than the preanalytical EQA influenced the actions and resulted in an increase in the percentages of participants that followed the guidelines for patient identification. Some aspects of blood sampling routines need improvement.

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).

It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting "Improving quality in the preanalytical phase through innovation" in Amsterdam, 24-25 March, 2017.

Analytical performance specifications based on how clinicians use laboratory tests. Experiences from a post-analytical external quality assessment programme.

Analytical performance specifications can be based on three different models: the effect of analytical performance on clinical outcome, based on components of biological variation of the measurand or based on state-of-the-art. Models 1 and 3 may to some degree be combined by using case histories presented to a large number of clinicians. The Norwegian Quality Improvement of Primary Care Laboratories (Noklus) has integrated vignettes in its external quality assessment programme since 1991, focusing on typical clinical situations in primary care. Haemoglobin, erythrocyte sedimentation rate (ESR), HbA1c, glucose, u-albumin, creatinine/estimated glomerular filtration rate (eGFR), and Internationl Normalised Ratio (INR) have been evaluated focusing on critical differences in test results, i.e., a change from a previous result that will generate an "action" such as a change in treatment or follow-up of the patient. These critical differences, stated by physicians, can translate into reference change values (RCVs) and assumed analytical performance can be calculated. In general, assessments of RCVs and therefore performance specifications vary both within and between groups of doctors, but with no or minor differences regarding specialisation, age or sex of the general practitioner. In some instances state-of-the-art analytical performance could not meet clinical demands using 95% confidence, whereas clinical demands were met using 80% confidence in nearly all instances. RCVs from vignettes should probably not be used on their own as a basis for setting analytical performance specifications, since clinicians seem "uninformed" regarding important principles. They could rather be used as a background for focus groups of "informed" physicians in discussions of performance specifications tailored to "typical" clinical situations.

How to conduct External Quality Assessment Schemes for the pre-analytical phase?

In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.

From biomarkers to medical tests: the changing landscape of test evaluation.

Regulators and healthcare payers are increasingly demanding evidence that biomarkers deliver patient benefits to justify their use in clinical practice. Laboratory professionals need to be familiar with these evidence requirements to better engage in biomarker research and decisions about their appropriate use. This paper by a multidisciplinary group of the European Federation of Clinical Chemistry and Laboratory Medicine describes the pathway of a laboratory assay measuring a biomarker to becoming a medically useful test. We define the key terms, principles and components of the test evaluation process. Unlike previously described linearly staged models, we illustrate how the essential components of analytical and clinical performances, clinical and cost-effectiveness and the broader impact of testing assemble in a dynamic cycle. We highlight the importance of defining clinical goals and how the intended application of the biomarker in the clinical pathway should drive each component of test evaluation. This approach emphasizes the interaction of the different components, and that clinical effectiveness data should be fed back to refine analytical and clinical performances to achieve improved outcomes. The framework aims to support the understanding of key stakeholders. The laboratory profession needs to strengthen collaboration with industry and experts in evidence-based medicine, regulatory bodies and policy makers for better decisions about the use of new and existing medical tests.

External quality assessment of point-of-care methods: model for combined assessment of method bias and single-participant performance by the use of native patient samples and noncommutable control materials.

BACKGROUND: An important objective in external quality assessment (EQA) is to evaluate systematic deviations between methods. However, this is not possible when noncommutable control materials are used. The aim of this study was to develop an EQA model that incorporates a method bias evaluation using native patient samples into EQA schemes in which noncommutable materials are used. METHODS: The model was applied twice in a point-of-care (POC) international normalized ratio survey among 1341 and 1578 participants. To estimate bias, about 100 native patient samples for each POC method were analyzed by a selected group of "expert" primary healthcare centers and on a designated comparison method. In addition, the expert centers as well as all the other EQA participants analyzed 2 noncommutable control materials, and method-specific target values were established. Both method bias and the deviation of a single-participant result from the method target value were evaluated against analytical quality specifications, making combined assessment possible. The best-case scenario occurred when both results were within the quality specifications. RESULTS: Two POC methods fulfilled the quality specification for bias, whereas one did not. The best-case scenario was achieved by more than 90% of the participants using the methods with no bias, whereas none of the participants using the method with unacceptable bias achieved this result. CONCLUSIONS: We propose an EQA model for which the bias of POC methods can be evaluated in situations in which commutable control materials are not available.

Establishing a network of specialist Porphyria centres - effects on diagnostic activities and services.

BACKGROUND: The porphyrias are a heterogeneous group of rare metabolic diseases. The full spectrum of porphyria diagnostics is usually performed by specialized porphyria laboratories or centres. The European Porphyria Initiative (EPI), a collaborative network of porphyria centres formed in 2001, evolved in 2007 into the European Porphyria Network (EPNET), where participating centres are required to adhere to agreed quality criteria. The aim of this study was to examine the state and distribution of porphyria diagnostic services in 2009 and to explore potential effects of increased international collaboration in the field of these rare diseases in the period 2006-2009. METHODS: Data on laboratory, diagnostic and clinical activities and services reported to EPI/EPNET in yearly activity reports during 2006 through 2009 were compared between reporting centres, and possible time trends explored. RESULTS: Thirty-five porphyria centres from 22 countries, five of which were non-European associate EPNET members, filed one or more activity reports to EPI/EPNET during the study period. Large variations between centres were observed in the analytical repertoire offered, numbers of analyses performed and type and number of staff engaged. The proportion of centres fulfilling the minimum criteria set by EPNET to be classified as a specialist porphyria centre increased from 80% to 94% during the study period. CONCLUSIONS: Porphyria services are unevenly distributed, and some areas are probably still lacking in specialized porphyria services altogether. However, improvements in the quality of diagnostic services provided by porphyria centres participating in EPI/EPNET were observed during 2006 through 2009.

Regional differences in sales of glucometer strips and antidiabetics.

BACKGROUND: Studies have shown that the prevalence of diabetes in Norway is 3-5 %, and that approximately 97,000 Norwegian patients perform self-monitoring of blood glucose. There is a need for studies of geographical differences in diabetes prevalence and treatment. This study investigates differences between counties in the prevalence of patients treated with antidiabetics in Norway, and in the use of glucometer strips. MATERIAL AND METHOD: Data on the sale of antidiabetes medication to non-institutionalized patients were acquired from the Norwegian Register of Prescriptions, while corresponding data on glucometer strips were received from the Norwegian Health Economics Administration (HELFO). RESULTS: We found a nationwide prevalence of medicinally treated diabetes of 2.9 %. The corresponding prevalence of use of glucometer strips was 2.1 %. There was a 27.5 % difference between the counties with the highest and lowest prevalence of medicinally treated diabetes, while the difference in use of glucometer strips was 31.5 %. The average cost of antidiabetes drugs was 23.7 % higher in the county with the highest average expenditure compared with the county with the lowest expenditure. There was a difference of up to 44 % between counties in the average purchase of glucometer strips per person. INTERPRETATION: The geographical differences may be due to different availability of health services or different therapy traditions. A shortage of guidelines on the frequency of self-monitoring of blood glucose may also have a bearing on the differences.

External quality assessment of point-of-care International Normalized Ratio (INR) testing in Europe.

BACKGROUND: Point-of-care testing (POCT) of prothrombin time, expressed as International Normalized Ratio (INR), is widely used to monitor patients in oral anticoagulation treatment. Guidelines recommend that POCT users should participate in an external quality assessment (EQA) scheme whenever available. The aim of this study was to investigate which European countries provide EQA for POCT INR and to compare how these schemes are organized. METHODS: Thirty European countries were invited to participate in this study. Those who reported that they provide EQA for POCT INR filled in a questionnaire dealing with different aspects of their schemes. RESULTS: Nineteen countries reported that they do not provide EQA for POCT INR, while 12 organizations from nine countries reported that they provide this service. Most of these countries circulate lyophilized samples with for the participants unknown target values. Samples with certified INR values and procedures using split samples with fresh patient samples are also used. The acceptability limits vary from 15% to 30%, and the total number of samples circulated per year varies from 1 to 12. Most of the countries organize educational activities together with their schemes. CONCLUSIONS: This study demonstrates that there is a wide variation in the way EQA for POCT INR is performed in Europe and that there are many European countries that do not provide this service. Even though our findings indicate that EQA for POCT INR draws some challenges, especially in providing suitable control materials, participation in such schemes is considered useful.

The prevalence of self-monitoring of blood glucose and costs of glucometer strips in a nationwide cohort.

OBJECTIVE: This study used nationwide data to determine the prevalence of self-monitoring of blood glucose (SMBG) among all non-institutionalized persons living in Norway and to estimate the prevalence of SMBG among diabetes patients, the frequency and cost of SMBG, and the use of different glucometers. METHODS: This retrospective, descriptive study is based on data of sales of glucometer strips to non-institutionalized persons in Norway in 2008. The data included gender, age group, month of purchase, sales place, type of strips, number of packages dispensed, and cost of strips. Additionally, statistics on sales of insulin and oral antidiabetes medications were obtained from the Norwegian Prescription Database. RESULTS: A total of 96,999 persons purchased strips, a prevalence of 2%. Approximately 70% of diabetes patients practiced SMBG. An average patient used 1.7 strips per day, and younger patients purchased more strips than older patients. Fewer than 50% of patients performed glucose measurements daily. One percent of patients used more than 10 strips daily and was accountable for 8% of total costs. Most patients used only one type of strips, but the number of strips purchased increased with the number of different strips. The average annual cost of strips was 446 euro per person. CONCLUSIONS: Two percent of all non-institutionalized inhabitants and an estimated 70% of patients using diabetes medication purchased SMBG strips. A small percentage of the patients incurred a substantial proportion of the costs. This, along with the fact that over half of the patients monitor less than once per day, calls for tighter follow-up of diabetes patients.

Self-monitoring of blood glucose with a focus on analytical quality: an overview.

Self-monitoring of blood glucose (SMBG) has been available for patients with diabetes for more than 30 years. Today, SMBG is an important component in diabetes management, helping patients achieve and maintain normal blood glucose concentrations. Implementation of SMBG as an effective glycaemic control tool requires that instruments have acceptable analytical quality, that the patients are educated in using them, and that actions are taken upon the results. This paper gives an overview of SMBG, including the history, clinical utility, principles of measurement and several aspects of analytical quality of SMBG. The latter comprises a standardised evaluation of SMBG performance, quality specifications as well as different approaches to monitor the quality of SMBG performance.

Implementation of a method for glucose measurements in community pharmacies.

OBJECTIVES: We aimed to implement a method for glucose measurements that could be used as a comparison method for asessing patients' self-monitoring of blood glucose. Further, we investigated whether pharmacies could achieve an analytical quality comparable to glucose measurements performed in general practice. METHODS: Sixteen Norwegian pharmacy employees were trained in glucose measurement, quality control and blood sampling. The comparison method, HemoCue Glucose 201+, was validated in four steps: (1) estimation of the variation between the HemoCue instruments to be used at the 16 pharmacies, (2) comparison between HemoCue results and a laboratory glucose method, (3) monitoring quality by internal quality controls and (4) an external quality-assessment scheme. The pharmacies' results of the external quality assessment were compared to those of 359 general practices. KEY FINDINGS: The coefficient of variation for HemoCue instruments was 6.1% at the low level and 1.7% at the normal and high levels. Bias was negligible at the normal level. The coefficients of variation for internal quality controls were 4.5, 1.5 and 1.2% for the low, normal and high levels, respectively. All pharmacies achieved good precision and acceptable or good trueness in the external quality assessment. The pharmacies exhibited significantly lower variation between sites (2.2 and 1.2%) than general practices (3.8 and 2.9%) on both external quality-assessment samples. CONCLUSIONS: Given correct training and the establishment of a system of quality assurance, pharmacies are capable of obtaining glucose measurements that can be used as comparison measurements for controlling patients' meters. The pharmacies had external quality-assessment results comparable to general practice.

Quality assessment of patients' self-monitoring of blood glucose in community pharmacies.

OBJECTIVE: To evaluate diabetes patients' self-monitoring of blood glucose using a community pharmacy-based quality assurance procedure, to investigate whether the procedure improved the quality of the patient performance of self monitoring of blood glucose, and to examine the opinions of the patients taking part in the study. METHODS: The results of patient blood glucose measurements were compared to the results obtained with HemoCue Glucose 201(+) by pharmacy employees in 16 Norwegian community pharmacies. Patient performance was monitored using an eight item checklist. Patients whose blood glucose measurements differed from pharmacy measurements by more than 20% were instructed in the correct use of their glucometer. The patients then re-measured their blood glucose. If the results were still outside the set limits, the control procedure was repeated with a new lot of glucometer strips, and then with a new glucometer. The patients returned for a follow-up visit after three months. RESULTS: During the first visit, 5% of the 338 patients had measurements that deviated from pharmacy blood glucose values by more than 20% and user errors were observed for 50% of the patients. At the second visit, there was no significant change in the analytical quality of patient measurements, but the percentage of patients who made user errors had decreased to 29% (p < 0.001). Eighty-five percent of the patients reported that they used their blood glucose results to adjust medication, exercise or meals. Fifty-one percent of the patients reported a greater trust in their measurements after the second visit. Eighty percent of patients wished to have their measurements assessed yearly. Of these patients, 83% preferred to have the assessment done at the community pharmacy. CONCLUSION: A community pharmacy-based quality assessment procedure of patients' self monitoring of blood glucose significantly reduced the number of user errors. The analytical quality of the patients' measurements was good and did not improve further during the study. The high analytical quality might be explained by a selection bias of participating patients. Patients also reported increased confidence in their blood glucose measurements after their measurements had been assessed at the pharmacy.

Postanalytical external quality assessment of urine albumin in primary health care: an international survey.

BACKGROUND: Microalbuminuria (MA) is recognized as an important risk factor for cardiovascular and renal complications in diabetes. We sought to evaluate how screening for MA is conducted and how urine albumin (UA) results are interpreted in primary care internationally. METHODS: General practitioners (GPs) received a case history-based questionnaire depicting a male type 2 diabetes patient in whom UA testing had not been performed. Questions were related to type of urine sample used for UA testing, need for a repeat test, whether UA testing was performed in the office laboratory, and what changes in UA results were considered clinically important [critical difference (CD)]. Participants received national benchmarking feedback reports. RESULTS: We included 2078 GPs from 9 European countries. Spot urine samples were used most commonly for first time office-based testing, whereas timed collections were used to a larger extent for hospital-based repeat tests. Repeat tests were requested by 45%-77% of GPs if the first test was positive. Four different measurement units were used by 70% of participants in estimating clinically important changes in albumin values. Stated CDs varied considerably among GPs, with similar variations in each country. A median CD of 33% was considered clinically important for both improvement and deterioration in MA, corresponding to an achievable analytical imprecision of 14%, when UA is reported as an albumin/creatinine ratio. CONCLUSIONS: Guidelines on diagnosing MA are followed only partially, and should be made more practicable, addressing issues such as type of samples, measurement units, and repeat tests.