Harmonisation of seven common enzyme results through EQA.

BACKGROUND: Equivalent results between different laboratories enable optimal patient care and can be achieved with harmonisation. We report on EQA-initiated national harmonisation of seven enzymes using commutable samples. METHODS: EQA samples were prepared from human serum spiked with human recombinant enzymes. Target values were assigned with the IFCC Reference Measurement Procedures. The same samples were included at four occasions in the EQA programmes of 2012 and 2013. Laboratories were encouraged to report IFCC traceable results. A parallel study was done to confirm commutability of the samples. RESULTS: Of the 223 participating laboratories, 95% reported IFCC traceable results, ranging from 98% (ASAT) to 87% (amylase). Users of Roche and Siemens (97%) more frequently reported in IFCC traceable results than users of Abbott (91%), Beckman (90%), and Olympus (87%). The success of harmonisation, expressed as the recovery of assigned values and the inter-laboratory CV was: ALAT (recovery 100%; inter-lab CV 4%), ASAT (102%; 4%), LD (98%; 3%), CK (101%; 5%), GGT (98%; 4%), AP (96%; 6%), amylase (99%; 4%). There were no significant differences between the manufacturers. Commutability was demonstrated in the parallel study. Equal results in the same sample in the 2012 and 2013 EQA programmes demonstrated stability of the samples. CONCLUSIONS: The EQA-initiated national harmonisation of seven enzymes, using stable, commutable human serum samples, spiked with human recombinant enzymes, and targeted with the IFCC Reference Measurement Procedures, was successful in terms of implementation of IFCC traceable results (95%), recovery of the target (99%), and inter-laboratory CV (4%).

Practical application of Sigma Metrics QC procedures in clinical chemistry.

BACKGROUND: Many labs have not yet selected the most appropriate Westgard Quality Control (QC) rule for each test. This is mainly due to the apparent complexity of the matter. METHODS: From the Westgard OPSpecs Charts QC planning tool and the Sigma Metrics formula's it was deduced that every Westgard rule has its own Sigma value. This was converted to an easy three-step road map to optimal Westgard QC rules. RESULTS: The road map provided is based on Sigma Metrics that hold a definition of "world class quality", at which no further effort to increase quality needs to be taken. Furthermore, it is shown that clinical chemical tests can be classified as "good": quality at or above world class, "bad": quality below world class but controllable with Westgard QC rules and "ugly": quality not controllable with Westgard QC rules alone. Finally, practical tips of how to deal with this and related aspects are given. CONCLUSIONS: The use of the road map based on Sigma Metrics leads to fast and easy implementation of optimal Westgard QC rules.

Automated and cost-efficient early detection of hemolysis in patients with extracorporeal life support: Use of the hemolysis-index of routine clinical chemistry platforms.

PURPOSE: Patients with extracorporeal life support (ECLS) are at risk for hemolysis-related complications. Therefore, monitoring of free hemoglobin (fHb) levels is indicated. Conventional methods for fHb are laborious and not always available. Here we evaluated the suitability of the hemolysis-index (H-index), an internal quality control parameter of clinical chemistry platforms, as a clinical parameter for ECLS patients. MATERIALS AND METHODS: The performance of the H-index assay was evaluated using standard procedures. Furthermore, H-index data from ECLS patients (n = 56) was analyzed retrospectively. RESULTS: The H-index significantly correlated with fHb and showed good analytical performance. During ECLS 19.6% of the patients had an H-index above 20 in at least 2 consecutive blood draws, indicating significant hemolysis. In the patients with clot formation in the pumphead the H-index peaked above 100. Visible clots at other locations did not always coincide with hemolysis. H-index peaks were more prevalent in patients that died during ECLS support. CONCLUSIONS: We conclude that the H-index is a suitable and cost-efficient alternative for the conventional fHb analysis with good analytic performance. The H-index aids in the early detection of hemolysis in patients with ECLS. A repeated H-index>20 was a predictor of mortality.

Persistent changes in circulating white blood cell populations after splenectomy.

The effect of splenectomy on the incidence of infections and thromboembolisms has been investigated thoroughly. Nevertheless, the long-term effects of splenectomy on immunological profile and circulating blood counts have not been described before. To study such long-term effects, we analysed several parameters in splenectomised trauma patients and compared the results of this group ("otherwise healthy patients") to patients with a specific underlying disease. We measured platelet count, leukocytes and differential, lymphocyte subsets, serum levels of immunoglobulins, and complement pathways in 113 patients. Indications to perform a splenectomy were trauma (n = 42), Hodgkin lymphoma (n = 24), hereditary spherocytosis (n = 21), and immune thrombocytopenia (n = 26). In trauma patients lymphocytes and lymphocytes subsets were particularly elevated compared to normal population values. Splenectomised patients with Hodgkin lymphoma had significant lower numbers of T lymphocytes than trauma patients. Significant increases in platelets, leukocytes, and monocytes were observed in patients with hereditary spherocytosis. Occurrence of MBL genotype was different in ITP patients than in other splenectomised groups and the normal population. In splenectomised patients (> 4 years), platelet counts and lymphocyte subsets are increased which persist over time. As a result, these blood counts in splenectomised patients differ from reference values in the normal population.

Systematic monitoring of standardization and harmonization status with commutable EQA-samples--five year experience from the Netherlands.

BACKGROUND: Equivalence of results among laboratories is a major mission for medical laboratories. Monitoring of test equivalence is structurally integrated in the Dutch External Quality Assessment (EQA) scheme since 2005. Commutable poolsera, single donation "spy" sera and biological variance tolerance limits have been introduced in the EQA scheme for evaluation of the degree of test equivalence and its determinants. METHODS: In the annual cycle scheme 24 samples, covering the (patho)physiological measuring range for 17 analytes, are assayed by 220 participating laboratories at biweekly intervals. Test equivalence was evaluated by calculating overall median interlaboratory coefficients of variation (CVs) and its bias and imprecision components. Data from 2005 and 2010 schemes are evaluated to investigate trends in performance and success of standardization efforts. RESULTS: Overall median interlaboratory CVs in 2010 were mostly better than in 2005. Median interlaboratory CVs became <5% for electrolytes and substrates, and <10% for enzymes. Improvement in median interlaboratory CVs over these five years is mainly explained by improved method standardization, especially for enzymes and creatinine. CONCLUSION: The Dutch EQA-program proves to be a powerful instrument to evaluate test equivalence. It allows monitoring standardization efforts in a highly effective way and gives insight into remaining standardization potential.