Gunn B.B. Kristensen

Standardized Evaluation of Nine Instruments for Self-Monitoring of Blood Glucose

BACKGROUND Instruments for self-monitoring of blood glucose (SMBG) should undergo a standardized evaluation including a user-test before being marketed. In this study the results from standardized evaluations of nine different SMBG instruments are presented, and the standardized evaluation is discussed. METHODS Approximately 80 diabetes patients using three lots of test strips participated in each evaluation. Half of the patients were educated in how to use the meter, and the evaluations were carried out by both medical laboratory technologists (MLTs) and patients. Questionnaires were used to assess the user manual and the user-friendliness of the instrument. RESULTS The imprecision obtained by the patients (coefficients of variation [CVs] of 3.2-8.1%) were generally higher compared to that by the MLT (CVs of 2.3-5.9%). Three of the nine instruments did not achieve the quality goal based on the recommendation in the International Organization for Standardizations ISO 15197 guideline in the hands of diabetes patients. The bias from the comparison method ranged from -10.4% to +3.2%. There were significant lot-to-lot variations and hematocrit effects for some of the instruments. Temperature difference between the instruments and the test strip caused deterioration of the quality in one instrument. The user-friendliness was in general acceptable. CONCLUSIONS The quality of instruments for SMBG seems to have improved during recent years, although there are still analytical problems. A standardized evaluation protocol is necessary and should be regularly revised taking into account the development of new technology and the needs of the patients.

Preanalytical quality improvement. in pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE)

Abstract Laboratory diagnostics develop through different phases that span from test ordering (pre-preanalytical phase), collection of diagnostic specimens (preanalytical phase), sample analysis (analytical phase), results reporting (postanalytical phase) and interpretation (post-postanalytical phase). Although laboratory medicine seems less vulnerable than other clinical and diagnostic areas, the chance of errors is not negligible and may adversely impact on quality of testing and patient safety. This article, which continues a biennial tradition of collective papers on preanalytical quality improvement, is aimed to provide further contributions for pursuing quality and harmony in the preanalytical phase, and is a synopsis of lectures of the third European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled ‘Preanalytical quality improvement. In pursuit of harmony’ (Porto, 20–21 March 2015). The leading topics that will be discussed include unnecessary laboratory testing, management of test request, implementation of the European Union (EU) Directive on needlestick injury prevention, harmonization of fasting requirements for blood sampling, influence of physical activity and medical contrast media on in vitro diagnostic testing, recent evidence about the possible lack of necessity of the order of draw, the best practice for monitoring conditions of time and temperature during sample transportation, along with description of problems emerging from inappropriate sample centrifugation. In the final part, the article includes recent updates about preanalytical quality indicators, the feasibility of an External Quality Assessment Scheme (EQAS) for the preanalytical phase, the results of the 2nd EFLM WG-PRE survey, as well as specific notions about the evidence-based quality management of the preanalytical phase.

Self-Monitoring of Blood Glucose in Type 1 Diabetes Patients with Insufficient Metabolic Control: Focused Self-Monitoring of Blood Glucose Intervention Can Lower Glycated Hemoglobin A1C

Objective: Little attention has been given and few studies have been published focusing on how to optimize self-monitoring of blood glucose (SMBG) use to monitor daily therapy for persons with type 1 diabetes mellitus. This study was designed to evaluate the effect on glycated hemoglobin (A1C) of a structured intervention focused on SMBG in type 1 diabetes patients with insufficient metabolic control (A1C ≥ 8%) using a randomized clinical trial design. Method: One hundred fifty-nine outpatients with type 1 diabetes on multiple injection therapy with insulin and A1C ≥8% were recruited and randomized to one group receiving a focused, structured 9-month SMBG intervention (n = 59) and another group receiving regular care based on guidelines (n = 64). Results: Glycated hemoglobin values (mean % ± standard deviation) at study start was similar: 8.65 ± 0.10 in the intervention group and 8.61 ± 0.09 in the control group. The two groups were comparable (age, gender, body mass index, complication rate, and treatment modality) at study start and had mean diabetes duration and SMBG experience of 19 and 20 years, respectively. At study end, there was decrease in A1C in the intervention group (p < .05), and the A1C was 0.6% lower compared with the control group (p < .05). No increase in the number of minor or major hypoglycemia episodes was observed in the intervention group during the study period. Conclusions: A simple, structured, focused SMBG intervention improved metabolic control in patients with longstanding diabetes type 1 and A1C ≥ 8%. The intervention was based on general recommendations, realistic in format, and can be applied in a regular outpatient setting.

Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)

Abstract Background: An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines. Methods: A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart. Results: Twelve European countries participated with a median of 33 (18–36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 26.9 % (10.6–43.8), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labelling policy. Conclusions: The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labelling.

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.

Patient identification and tube labelling - a call for harmonisation.

Abstract Venous blood sampling (phlebotomy) is the most common invasive procedure performed in patient care. Guidelines on the correct practice of phlebotomy are available, including the H3-A6 guideline issued by the Clinical Laboratory Standards Institute (CLSI). As the quality of practices and procedures related to venous blood sample collection in European countries was unknown, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase conducted an observational study in 12 European countries. The study demonstrated that the level of compliance of phlebotomy procedures with the CLSI H3-A6 guideline was unacceptably low, and that patient identification and tube labelling are amongst the most critical steps in need of immediate attention and improvement. The process of patient identification and tube labelling is an essential safety barrier to prevent patient identity mix-up. Therefore, the EFLM Working Group aims to encourage and support worldwide harmonisation of patient identification and tube labelling procedures in order to reduce the risk of preanalytical errors and improve patient safety. With this Position paper we wish to raise awareness and provide recommendations for proper patient and sample identification procedures.

Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

Abstract It has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

Calcium, Magnesium, Albumin, and Total Protein Measurement in Serum as Assessed with 20 Fresh-Frozen Single-Donation Sera

To the Editor: The scope of external quality assessment (EQA)1 in laboratory medicine has evolved considerably (1). With the increasing worldwide interest in the use of common reference intervals and/or medical-decision limits, modern EQA schemes need to be better at assessing the standardization status of commercial in vitro diagnostic tests. This need has led to new challenges in the design of EQA surveys. We report the outcomes of a Norwegian pilot study that investigated the use of commutable, fresh-frozen single donations to assess the current standardization status as part of an initiative toward producing common reference intervals (2). The study covered measurements of calcium, magnesium, albumin, and total protein in serum from 20 single-donation blood samples obtained from Solomon Park Research Laboratories. Serum was generated according to CLSI protocol C37-A, with 2 U human thrombin (Sigma-Aldrich) added per milliliter of plasma to facilitate clotting (3); filtration was not used. Aliquots of these samples were sent to laboratories that used the same test systems (instrument, reagent, and calibrator from the same source). Five peer groups (n ≥ 6 laboratories each; N = 47) were considered: Abbott Diagnostics ARCHITECT, Ortho Clinical Diagnostics VITROS, …

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

Abstract 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. Clin Chem Lab Med 2010;48:963–72.

The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe

Patient safety is a leading challenge in healthcare and from the laboratory perspective it is now well established that preanalytical errors are the major contributor to the overall rate of diagnostic and therapeutic errors. To address this, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase (EFLM WG-PRE) was established to lead in standardization and harmonization of preanalytical policies and practices at a European level. One of the key activities of the WG-PRE is the organization of the biennial EFLM-BD conference on the preanalytical phase to provide a forum for National Societies (NS) to discuss their issues. Since 2012, a year after the first Preanalytical phase conference, there has been a rapid growth in the number of NS with a working group engaged in preanalytical phase activities and there are now at least 19 countries that have one. As a result of discussions with NS at the third conference held in March 2015 five key areas were identified as requiring harmonisation. These were test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens. The article below summarises the work that has and will be done in these areas. The goal of this initiative is to ensure the EFLM WG-PRE produces work that meets the needs of the European laboratory medicine community. Progress made in the identified areas will be updated at the next preanalytical phase conference and show that we have produced guidance that has enhanced standardisation in the preanalytical phase and improved patient safety throughout Europe.