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The use of gamma glutamyl transpeptidase (GGT) levels as screening test for liver function is controversial. The GGT main utility is in cases in which alkaline phosphatase (ALP) is elevated. We aimed to investigate the request over time for alanine amino transferase (ALT), ALP and GGT, study the effect of a new demand management (DM) intervention for optimal GGT measurement in primary care. Our descriptive study was conducted from January 2010 to December 2020. The intervention was established in November 2019 and consisted of the laboratory information system would automatically remove GGT, if the test had been ordered simultaneously with ALP and there was no prior pathological result on record. We counted the absolute number of measured ALT, ALP and GGT, and calculated the ratios for each of the three markers related to creatinine, and GGT related to ALT in a monthly basis. The number of measured GGT increased slightly and progressively along the study until October 2019, when a decrease was observed. The ALT and ALP request from primary care also increased slightly along years. However, the GGT/ALT ratio never reached the 0.2 goal. Out of the 57,614 GGT requested in primary care patients, 38,167 (66.2%) were not measured. 7633.4€ were saved in reagent. The DM intervention to reduce the measurement of GGT when requested redundantly with ALP in primary care was successful, and the results have been maintained over time as observed by monitoring the GGT/CREA and GGT/ALT indicator results.

(1) Background: There are no real-world data evaluating the incidence of false-positive results. We analyzed the clinical and analytical factors associated with the presence of false-positive results in PSA determinations in practice. (2) Methods: A prospective cohort study of patients with a PSA test was performed in clinical practice. We followed the patients by reviewing their medical records for 2 years or until the diagnosis of PCa was reached, whichever came first. (3) Results: False-positive PSA rate was 46.8% (95% CI 44.2–49.2%) and false-negative PSA rate was 2.8% (95% CI 2–3.5%). Patients aged 61–70 years and those over 70 years were more likely to have a false-positive result than those under 45 years (aOR 2.83, 95% CI 1.06–7.55, p = 0.038, and aOR 4.62, 95% CI 1.75–12.22, p = 0.002, respectively). Patients with urinary tract infection were more likely to have a false-positive result (aOR 8.42, 95% CI 2.42–29.34, p = 0.001). Patients with diabetes mellitus were less likely to have a false-positive result (aOR 0.63, 95% CI 0.41–0.98, p = 0.038); (4) Conclusions: This study has generated relevant information that could be very useful for shared decision making in clinical practice.

Objective To illustrate the changes in stat laboratory procedures over a 10 year period. Materials and Methods We implemented 5 different interventions: reporting total bilirubin through the icteric index, replacing total proteins for albumin, reporting albumin-adjusted calcium in hyper- or hypocalcemia, using lipase as a first marker and amylase-selected scenario, and measuring magnesium in hypocalcemia, hypokalemia, or high lipase values. Results Only 9.9% of total bilirubin that was requested was measured, which resulted in savings of $22,492.83. There were 30,036 albumin tests measured, and $15,625.18 was saved replacing total protein. There was $41,374.38 spent to measure lipase and amylase; the difference in costs from the lipase establishment was $16,929.62. Finally, $382.30 was spent for magnesium: 717 magnesium levels were measured given hypocalcemia or hypokalemia (42.8% hypomagnesemia), and 123 tests were added because of high lipase (35% hypomagnesemia). Overall, $53,374.15 was saved. Conclusion Progressive changes in stat laboratory procedures resulted in more efficient resources expenditures.

Objectives We aimed to share a new laboratory model based on laboratory knowledge, meaningful use of information technology, and partnership with clinicians, to lead the appropriate use of laboratory testing and clinical decision making in the diagnosis of as-yet-undiagnosed disease. More specifically, we evaluate the role of eight different opportunistic interventions to diagnose certain asymptomatic disorders, by means of the automatic registration of appropriate laboratory testing according to different scenarios. Methods This is a retrospective longitudinal study to evaluate the impact of laboratory interventions on the diagnosis of different diseases and on patient care, including data from January 2012 to September 2020. Results Overall, the above strategies have so far identified 2063 patients with clinically relevant as-yet-undiagnosed disorders who would have otherwise remained occult, such as for instance, primary hyperparathyroidism, diabetes, and hypomagnesemia. Conclusions We are facing a new laboratory model, a leading laboratory rather than a passive traditional laboratory, not just to intervene in clinical decision-making, but to make the clinical decision, through the identification of patients with occult disease.

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Objectives Several studies have shown an inverse association between diabetes mellitus and prostate cancer (PCa). Some researchers suggest that this relationship is due to reduced PCa detection in diabetics due to lower prostate-specific antigen (PSA) levels compared to non-diabetics. Our objective is to analyze the impact of diabetes on PSA in asymptomatic men without known prostate pathology and without prior prostate intervention. Methods We searched Medline (via PubMed), Embase and Scopus. We included studies that reported the relationship between serum PSA levels and diabetes or diabetes treatment in asymptomatic adult men without known prostate pathology, and without prior prostate intervention. Pooled mean differences were compared between diabetics and non-diabetics. Results Of 2,392 screened abstracts, thirteen studies met the inclusion criteria and 8 (62%) reported appropriate measures that could be included in a meta-analysis. Eleven (85%) examined the influence of diabetes on PSA levels and 8 (62%) evaluated the influence of diabetes treatments on PSA levels. Overall diabetics had a significantly lower PSA level compared to non-diabetics (mean difference: −0.07 ng/mL; 95% CI −0.10, −0.04). Conclusions Diabetes and related factors (such as disease duration, severity and treatment) were significantly associated with lower PSA levels among asymptomatic men, yet differences were small and are unlikely to influence PCa detection in a screening setting.

Introduction To test the efficacy of two interventions to promote the measurement of serum vitamin B12 (s- vitamin B12) in patients with long-term proton pump inhibitor (PPI) use and to decrease inadequate s-vitamin B12 measurement by implementing a minimum retest interval. Material and Methods The Laboratory Information System (LIS) automatically registered s-vitamin B12 when not ordered by General Practitioners to all requests patients with long term (>3years) PPI treatment, and with no s-vitamin B12 testing in the previous year. Through the second intervention, the LIS reported the previous s-vitamin B12 result through an explanatory comment in the report, when the test had been requested in the previous three months. We calculated the new diagnoses of vitamin deficiency (s-vitamin B12 Results The strategy added 548 s-vitamin B12 and identified 47 new cases of vitamin B12 deficit. The number of added s-vitamin B12 needed to identify a new case by means of the intervention was 12. The total intervention reagent cost was 1446€, with a cost of 30.7€ per new case. The second intervention avoided unnecessary measurement of 611 tests, with 1613€ savings. Conclusions Through the two automated interventions we improved the diagnosis of vitamin B12 deficiency, and decreased inadequate redundant s-vitamin B12 measurement, cutting unnecessary laboratory costs.

Prompt identification of the clinical status and severity of COVID-19 can be a challenge in the emergency department (ED), as the clinical severity of the disease is variable, real-time reverse-transcription PCR (RT-PCR) results may not be immediately available, and imaging findings appear approximately 10 days after the onset of symptoms. There is currently no set of simple, readily available and fast battery of tests that can be used in the ED as prognostic factors. The purpose was to study laboratory test results in patients with COVID-19 at hospital emergency admission and to evaluate the results in non-survivors and their potential prognostic value. A profile of laboratory markers was agreed with the ED providers based on the International Federation of Clinical Chemistry and Laboratory Medicine recommendation of its usefulness, which was made in 218 patients with COVID-19. Non-survivors were significantly older, and the percentage of patients with pathological values of creatinine, albumin, lactate dehydrogenase (LDH), C reactive protein, prothrombin time, D-dimer, and arterial blood gas, PaO2/FIO2 and satO2/FIO2 indices were significantly higher among the patients with COVID-19 who died than those who survived. Patients who died also presented higher neutrophil counts. Among all studied tests, albumin and LDH were independent prognostic factors for death. The results of the study show pathology in nine laboratory markers in patients with COVID-19 admitted in the ED, valuable findings to take into consideration for its prompt identification when there is no immediate availability of RT-PCR results.

Background Vitamin B12 deficiency is common worldwide and is also linked to several diseases including autoimmune atrophic gastritis (AAG). The presence of anti-parietal cell antibodies (APCA) and/or intrinsic factor blocking antibodies (IFBA) is indicative of AAG that may develop into pernicious anemia. Both conditions are known to be associated with an increased risk of gastric carcinoma. The aim of this study was to estimate the frequency of individuals positive for APCA and IFBA antibodies in primary care patients with severe vitamin B12 deficiency. Methods An observational study was designed and 5468 consecutive patients from primary care with a request for vitamin B12 status were included and add-on testing for APCA and IFBA that were automatically registered if severe vitamin B12 deficiency was identified ( Results Seventy-seven patients with severe vitamin B12 deficiency were identified and out of these 44 (57%) presented with antibodies to APCA and 11 (14%) to IFBA, 25 (32.5%) had anemia, and 25 (32.5%) had macrocytosis. The majority of APCA and/or IFBA positive patients were found in the age group >70 years. Both anemia and macrocytosis were more common among APCA positive patients but the association was not statistically significant, neither was the correlation between IFBA status and anemia and/or macrocytosis. Among the patients with anemia, 10 (39%) had macrocytosis, although the rate of macrocytosis among patients with or without anemia did not differ significantly. Conclusions The automated analysis strategy of measuring antibodies to APCA and IFBA in patients with severe vitamin B12 deficiency, efficiently detected positivity in more than 60% the patients. The result point to the presence of a high rate of otherwise undetected AAG and the potential clinical utility of APCA and IFBA as markers in primary care.

Introduction The aim was to present two automated laboratory strategies designed to detect new cases of type 2 diabetes and prediabetes and improve their monitoring. Methods To improve diabetes diagnosis, we automatically registered the glycated hemoglobin (HbA1c) levels of every primary care patient between 25 and 46 years old in case of abnormal lipid testing when an HbA1c test had not been requested in the current order or during the previous year and when fasting glucose was > 100 mg/dl. We counted the number of detected cases of diabetes and prediabetes and calculated the cost per identified patient. To improve diabetes monitoring, the levels of HbA1c, total cholesterol, high- and low-density lipoprotein cholesterol and triglycerides and the spot urinary albumin-to-creatinine ratios (ACRs) were automatically registered in patients with diabetes when not ordered according to guidelines. We calculated the total economic costs according to the total number of additional registered tests and reagent cost. Results Of 103,425 requests, 224 (0.22%) met the inclusion criteria. Seventeen (7.6%) patients were identified as having new cases of diabetes and 149 (66.5%) of prediabetes, at a cost of €15.2 and €2.3, respectively, per case detected. From 13,874 requests in patients with diabetes, 91 HbA1c and 708 lipid tests and 862 ACRs were automatically registered to comply with guidelines, resulting in expenses of €1948.90. Conclusions Making use of laboratory technology, it is possible to detect new cases of type 2 diabetes and prediabetes and to improve disease monitoring.

Objective To improve clinical laboratory contribution to the treatment of primary care patients with anorexia through automated computerized strategies. Methods We recorded the number of laboratory requests due to anorexia; the demographic data, laboratory values, and presence of pathological values for the applicable patients. In a prospective study, the laboratory information management system (LIMS) automatically added thyroid-stimulating hormone (TSH) and/or ferritin testing when it was not requested by general practitioners for all primary care patients with anorexia who were younger than 16 years. Results A total of 3562 patients underwent laboratory testing due to anorexia, of whom 47% were younger than 16 years. The tests in which the results most frequently were abnormal were hemoglobin, ferritin, and TSH. TSH results were abnormal in 20% of patients younger than 16 years. Through the intervention, we detected 3 low ferritin values and 7 cases of pathological TSH levels. Conclusions The LIMS required TSH and ferritin testing in young patients even when not requested, potentially avoiding the adverse effects of iron deficiency and thyroid disorders on neurological development and cognition in those patients.

Background: Opportunistic prostate-specific antigen (PSA) screening may reduce prostate cancer mortality risk but is associated with false positive results, biopsy complications and overdiagnosis. Although different organisations have emphasised the importance of shared decision making (SDM) to assist men in deciding whether to undergo prostate cancer screening, recent evaluations show that the available decision aids fail to facilitate SDM, mainly because they do not consider the patients’ perspective in their design. We aim to systematically develop and test a patient decision aid to promote SDM in prostate cancer screening, following the Knowledge to Action framework. Methods: (1) Feasibility study: a quantitative survey evaluating the population and clinician (urologists and general practitioners) knowledge of the benefits and risks derived from PSA determination and the awareness of the available recommendations. Focus groups to explore the challenges patients and clinicians face when discussing prostate cancer screening, the relevance of a decision aid and how best to integrate it into practice. (2) Patient decision aid development: Based on this data, an evidence-based multicomponent SDM patient decision aid will be developed. (3) User-testing: an assessment of the prototype of the initial patient decision aid through a user-testing design based on mix-methods (questionnaire and semi-structured review). The decision aid will be refined through several iterative cycles of feedback and redesign. (4) Validation: an evaluation of the patient decision aid through a cluster-randomised controlled trial. Discussion: The designed patient decision aid will provide balanced information on screening benefits and risks and should help patients to consider their personal preferences and to take a more active role in decision making. Conclusions: The well-designed patient decision aid (PDA) will provide balanced information on screening benefits and risks and help patients consider their personal preferences. Article funded by the Instituto de Salud Carlos III, Ministry of Science and Innovation of the Government of Spain (Group 26 of the Centro de Investigación Biomédica en Red Epidemiología y Salud Pública, CIBERESP). Research funded by the research project of the Instituto de Salud Carlos III, code PI20/01334, Principal Investigator Dr. Blanca Lumbreras Lacarra, co-financed with FEDER funds from the European Union “A way of doing Europe”.

Scientific societies have provided guidelines to reduce PSA-specific harms. We studied the potential non-compliance of PSA testing with current guidelines in general practice. A cross-sectional study of a random sample of 1291 patients with a PSA test was performed between January and April 2018 in primary health care. Patients with a previous prostate cancer diagnosis or those who were being followed-up for previous high PSA values were excluded. Two independent researchers classified whether each test was potentially non-compliant with recommendations. We estimated frequencies of potentially non-compliant PSA determinations and calculated prevalence ratios (PR) to assess their relationship with possible explanatory variables. A total of 66% (95% CI: 62–69%) of PSA requests in asymptomatic patients were potentially non-compliant with the current guideline. This was associated with having a previous diagnosis of neoplasm (PR adjusted by age and life expectancy: 1.18, 95% CI: 1.02–1.37) as well as being a current consumer of tobacco, alcohol, or other drugs (PR: 0.80, 95% CI: 0.67–0.97). Real world data shows that patients are still frequently exposed to overdiagnosis risk with a PSA potentially non-compliant with recommendations. Patients diagnosed with another neoplasm or non-consumers of toxic substances were more exposed, probably due to increased contact with doctors or health-seeking behaviour.

Objectives Malnutrition is an unfavorable prognostic factor associated with an increase in mortality, hospital stays, readmissions and resources consumption. The aim was to screen primary care patients for risk of malnutrition by using the control nutritional (CONUT) score, calculated through total lymphocytes count, serum albumin and total cholesterol, when the three markers were requested, and to compare results between primary care centers (PCC). Methods The clinical laboratory located in a 370-bed suburban University Community Hospital serves the Health Department inhabitants (2,34,551), attended in nine PCC. The laboratory information system (LIS) automatically calculated the CONUT score in every primary care patient over 18 years old, when all three laboratory markers were ordered by the General Practitioner. For all primary care patients, we collected demographic data, CONUT index and PCC. We classified results by PCC, and compared them. Results The clinical laboratory received 74,743 requests from primary care. The CONUT score was calculated in 7,155 (12.28%) patients. Nine hundred seventy-six (13.6%) were at risk of malnutrition according to the CONUT score, mainly male (p Conclusions It is possible to use CONUT score as a front-line population-wide laboratory marker to screen for the risk for malnutrition in primary care patients that was lower in one PCC.

Background Risk of malnutrition can be evaluated through Controlling Nutritional (CONUT) Score based on total peripheral lymphocytes, serum albumin, and total cholesterol. Our aim was to automatically calculate CONUT in primary care when involved markers were requested and compare its performance with albumin to identify patients at risk of malnutrition. CONUT was evaluated according to patient age, and calculated the potential expenses to calculate CONUT, when serum markers were no requested, and measured. Methods We calculated CONUT when the three laboratory markers were requested, compared CONUT and albumin, considering risk of malnutrition CONUT ≥ 2, and albumin

To test the efficacy of two interventions to promote the measurement of serum vitamin BThe Laboratory Information System (LIS) automatically registered s-vitamin BThe strategy added 548 s-vitamin BThrough the two automated interventions we improved the diagnosis of vitamin B

INTRODUCTION: The significance of hypomagnesemia and the need for treatment are under-recognized in clinical practice. Our objective was to design, establish, and test two interventions to screen for patients with hypomagnesemia and increase the rate of treatment of hypomagnesemia in the Emergency Department (ED). MATERIAL AND METHODS: A prospective two-year study was conducted. The Laboratory Information System was set to automatically order plasma magnesium in ED patients with plasma calcium

Background To study the variability in the request of serum uric acid (SUA) in primary care. Method A cross-sectional study was designed and conducted at a main core laboratory. Spanish laboratories were invited to report their number of serum glucose (SG) and SUA tests requested from primary care during 2014. A survey was sent to every participant in November 2016 regarding the inclusion of SUA in order profiles/panels. The ratio of SUA/SG requests (SUA/SG) was calculated and compared between regions, and laboratories depending on whether SUA was included or not in a health check profile. Results 110 laboratories participated in the study (59.8% Spanish population). The median SUA/SG ratio was 0.82 (IQR: 0.25), and 41 laboratories had a ratio over 0.9. There was a significant regional variability (P = .008). Laboratories where SUA was not included in the "health check profile" had lower SUA/SG indicators (P = .003). Conclusion There was significant regional variability in the request of SUA, and an overall over-request. Different regional customs or habits and the inclusion of SUA in the health check profile were probable causes behind the observed over-request.

Background: The aim was to study the regional variability in the request of the ten most frequently ordered laboratory tests in primary care in Spain. Methods: Spain is divided into autonomous communities (AACC), first level health care divisions. Every AACC is divided into health departments (HDs). A laboratory attends the needs of every HD inhabitant. Laboratories from different HDs participated in the study. They reported the request of the ten most commonly requested laboratory tests in primary care during the year 2014 according to prior evidence: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, creatinine, γ-glutamyl transpeptidase (GGT), glucose, HDL-cholesterol, triglycerides, uric acid and urinalysis. Test-utilization rates were calculated as tests per 1000 inhabitants. Laboratories were grouped in the different AACC and the results for each region were compared using the coefficient of quartile dispersion (CQD), calculated using the first (Q1) and third (Q3) quartiles for each data set, as follows: (Q3−Q1)/(Q3+Q1). Results: One hundred and ten laboratories participated, corresponding to 27,798,262 inhabitants (59.8% Spanish population) from 15 AACC. 82,710,869 tests were requested. AST, GGT and uric acid showed the greatest variation. Conclusions: There were significant regional differences in how the most common laboratory tests were ordered in Spain.

AimTo study the regional variability of requests for anaemia chemistry tests in primary care in Spain and the associated economic costs of potential over-requesting.MethodsRequests for anaemia tests were examined in a cross-sectional study. Clinical laboratories from different autonomous communities (AACCs) were invited to report on primary care anaemia chemistry tests requested during 2014. Demand for iron, ferritin, vitamin B12 and folate tests per 1000 inhabitants and the ratios of the folate/vitamin B12 and transferrin/ferritin requests were compared between AACCs. We also calculated reagent costs and the number of iron, transferrin and folate tests and the economic saving if every AACC had obtained the results achieved by the AACC with best practice.Results110 laboratories participated (59.8% of the Spanish population). More than 12 million tests were requested, resulting in reagent costs exceeding €16.5 million. The serum iron test was the most often requested, and the ferritin test was the most costly (over €7 million). Close to €4.5 million could potentially have been saved if iron, transferrin and folate had been appropriately requested (€6 million when extrapolated to the whole Spanish population).ConclusionsThe demand for and expenditure on anaemia chemistry tests in primary care in Spain is high, with significant regional differences between different AACCs.

Background Preparation of the patient for laboratory tests is crucial. Our aim was to investigate the current practice and regional variability of recommendations regarding patient preparation for laboratory testing. Methods A call for data was posted by email. Spanish laboratories were invited to fill out and submit a survey. Results Sixty-eight laboratories participated in the study. In 73% of those laboratories, fasting was always recommended regardless of the requested tests. Only one-third of the laboratories systematically recommended a 12-hour fast before the tests. In 71% of the laboratories, water intake was allowed without restrictions during the fasting period. In 57% of the laboratories, computerized order entry offered the possibility to print customized recommendations automatically in the primary care doctor’s office according to the requested tests. Seventy-two percent of the laboratories agreed with the proposed recommendation. Conclusions There was high variability in patient preparation for laboratory testing. A significant proportion of centers did not follow international guidelines.

Introduction: Prostate-specific antigen (PSA) is the main tool for early detection, risk stratification and monitoring of prostate cancer (PCa). However, there are controversies about the use of PSA as a population screening test because of the high potential for overdiagnosis and overtreatment associated. The net benefit of screening is unclear and according to the available recommendations, it should be offered to well-informed men with an adequate health status and a life-expectancy of at least 10 years or to men at elevated risk of having PCa. In addition, the factors that influence test results are unclear, as is impact of false positive or negative results on patient health. Our objective is to assess the clinical and analytical factors associated with the presence of false positive and false negative results and the diagnostic/therapeutic process followed by these patients. Methods and analysis: A prospective observational cohort study will be carried out. We will include a cohort of patients with a positive PSA result (1.081 patients) and a sample of patients with negative results (572 patients); both will be followed for 2 years by reviewing medical records to assess the variables associated with these results, as well as characteristics of patient management after a positive PSA value. We will include those patients with a PSA determination from 2 hospitals in the Valencian Community. Patients who have been previously diagnosed with prostate cancer or who are being followed for previous high PSA values will be excluded. Discussion: The study will estimate the frequency of false positive and false negative PSA results in routine clinical practice, and allow us to quantify the potential harm caused. Study registration: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03978299, June 7, 2019.

Introduction The request of Urinary albumin in primary care in Spain is insufficient to monitor patients with diabetes and hypertension (HTN). Our aim was to evaluate a strategy designed in consensus with general practitioners (GPs) to improve the request of urinary albumin in primary care patients with HTN according to guidelines, and to study its financial implications. Materials and methods In a meeting with GPs, we decided that the Laboratory Information System (LIS) would automatically register the albumin-to-creatinine ratio (ACR) test in patients with HTN when the former had not been requested in the previous year. We counted the number of ACRs requested by the GPs, those that were automatically added through the intervention, and if they were measured through the strip assay or additionally through quantification. We calculated the economic cost of the additional registered ACR based on reagent cost. Results In the 6 months study period, the laboratory received 48,075 requests for primary care patients. For 3816 (7.9%), HTN was the indication that prompted the request. 386 ACR were automatically registered through the intervention. Use of strip analysis cost of 275.8 € but resulted in savings of 1450.3€ in albumin reagent. Conclusions By making use of the laboratory technology, the strategy achieved a better adherence to the guidelines at no additional cost.

Background and objectives Laboratory tests are crucial for diagnosis and monitoring of thyroid disorders. It is therefore necessary to study the pattern and variability in requests of thyroid function tests. The study objectives were to compare the inter-regional variability in the request of laboratory thyroid tests by general practitioners (GPs) in Spain, and to investigate the potential economic savings if the goals set for some suitability indicators were reached. Methods Test requests per 1000 inhabitants and test ratios (free thyroxine (FT4)/thyrotropin (TSH), free triiodothyronine (FT3)/TSH, thyroglobulin antibody (TgAb)/peroxidase antibody (TPOAb)) were compared between the different areas, according to their setting, location, and management. The resulting savings if each department achieved the goals for indicator (0.25 for FT4/TSH, 0.1 for FT3/TSH) were estimated. Results Seventy-six laboratories covering a population of 17,679,195 inhabitants participated in the study. TSH was requested significantly less in urban-rural areas, and the requests for FT3/1000 inhabitants, FT3/TSH, and TgAb/TPOAb were higher in departments with private management. The savings generated if specifications for the ratios of related tests were met would be 937,260.5 €. Conclusions The high variability reported in requests for thyroid function and autoimmunity tests in Spain suggests the need for implementing strategies to improve use of such tests.

Introduction Many additional tasks in the Stat laboratory (SL) increase the workload. It is necessary to control them because they can affect the service provided by the laboratory. Our aim is to calculate these tasks, study their evolution over a 10 year period, and compare turnaround times (TAT) in summer period to the rest of the year. Materials and methods Additional tasks were classified as "additional test request" and "additional sample". We collected those incidences from the laboratory information system (LIS), and calculated their evolution over time. We also calculated the monthly TAT for troponin for Emergency department (ED) patients, as the difference between the verification and LIS registration time. A median time of 30 minutes was our indicator target. TAT results and tests workload in summer were compared to the rest of the year. Results Over a 10-year period, the technologists in the SL performed 51,385 additional tasks, a median of 475 per month. The workload was significantly higher during the summer (45,496 tests) than the rest of the year (44,555 tests) (P = 0.019). The troponin TAT did not show this variation between summer and the rest of the year, complying always with our 30 minutes indicator target. Conclusion The technicians accomplished a significant number of additional tasks, and the workload kept increasing over the period of 10 years. That did not affect the TAT results.

Background The clinical laboratory plays a crucial role in the diagnosis and monitoring of chronic kidney disease. The quantitative measurement of urine albumin in a spot sample, expressed as ratio per creatinine (ACR) is the most frequently used biomarker for such a purpose. Our aim was to evaluate the diagnostic performances of a strip for measuring ACR for differentiating patients who are candidates for subsequent albumin quantification, and to evaluate the economic effects of its implementation. Methods We systematically measured strip analysis when quantitative urinary albumin was requested. Semiquantitative urinary albumin was measured using a UC-3500 (Sysmex, Kobe, Japan), based on the protein error of a pH indicator. We collected and reviewed all the values of quantified urinary albumin and their corresponding results in ACR strip tests. We calculated the diagnostic indicators for ACR at different albumin and creatinine values using the quantitative ACR measurement as a “gold standard”. We also studied the economic effects based on both tests prices (€1.31 for quantitative albumin plus creatinine, and €0.04 for an albumin strip). Results The study included 9148 patients (mean age 63, 46.3% men). The results at different albumin and creatinine cutoffs showed the best performance when 10 mg/L and above 50 mg/dL, respectively. Based on our results, we would have saved 3506 urine albumin and creatinine tests in the study period, corresponding to €4226.94. Conclusions The present study supports the use of the ACR strip test to identify pathological albuminuria values to be measured through quantitative methods. Considerable economic savings are possible.

The objective of this review article is to address the most frequently asked questions that pathologists and primary care physicians might face when dealing with a patient with suspicion of vitamin B12 deficiency. More specifically, the article mainly discusses the importance and prevalence of the deficit, how to recognize it, and the important role of a prompt diagnosis confirmation based on laboratory biomarkers for efficient replacement therapy.

BACKGROUND To study the urinalysis request, pre-analytical sample conditions, and analytical procedures. METHODS Laboratories were asked to provide the number of primary care urinalyses requested, and to fill out a questionnaire regarding pre-analytical conditions and analytical procedures. RESULTS 110 laboratories participated in the study. 232.5 urinalyses/1,000 inhabitants were reported. 75.4% used the first morning urine. The sample reached the laboratory in less than 2 hours in 18.8%, between 2 - 4 hours in 78.3%, and between 4 - 6 hours in the remaining 2.9%. 92.5% combined the use of test strip and particle analysis, and only 7.5% used the strip exclusively. All participants except one performed automated particle analysis depending on strip results; in 16.2% the procedure was only manual. CONCLUSIONS Urinalysis was highly requested. There was a lack of compliance with guidelines regarding time between micturition and analysis that usually involved the combination of strip followed by particle analysis.

Background: Severe vitamin B12 deficiency can result in serious complications If undiagnosed or untreated. Our aim was to test the efficacy of interventions in the laboratory process to improve the detection and the treatment of severe vitamin B12 deficiency. Methods: Quasi-experimental investigation with a retrospective 7-year pre-intervention period and 29-month post-intervention follow-up in a university hospital. Two interventions were designed to improve the detection and treatment of subjects with vitamin B12 deficiency: the laboratory information system (LIS) automatically added seru vitamin B12 (s-vitamin B12) based on certain conditions; and created a comment in the report and scheduled an appointment with the general practitioner (GP). We calculated the number of new diagnoses of severe vitamin deficiency (s-vitamin B12

Objective To compare the ratios of requests of aspartate aminotransferase (AST) to alanine aminotransferase (ALT) and urea to creatinine (Crea); to investigate the variability among regions and to calculate the potential savings if a target is reached. Methods Laboratories were invited to fill out a registration form on the number of AST, ALT, Urea and Crea requested in 2014, and to provide the reagent price of urea and AST. AST:ALT and Urea:Crea were calculated and compared; also compared were potential savings if each laboratory would have reached the target. Results: A significant difference was found among regions in Urea:Crea. Twenty-one laboratories reached the goal in AST:ALT, and 6 in Urea:Crea. The potential savings if each indicator would have reached the target would have been $553,827 and $745,184, respectively. Conclusion Variability was found in AST:ALT and Urea:Crea, which resulted in a significant unnecessary financial burden and suggests the need to promote the optimal requesting rate.

To apply a continual improvement model to develop an algorithm for ordering laboratory tests to diagnose acute pancreatitis in a hospital emergency department.Quasi-experimental study using the continual improvement model (plan, do, check, adjust cycles) in 2 consecutive phases in emergency patients: amylase and lipase results were used to diagnose acute pancreatitis in the first phase; in the second, only lipase level was first determined; amylase testing was then ordered only if the lipase level fell within a certain range. We collected demographic data, number amylase and lipase tests ordered and the findings, final diagnosis, and the results of a questionnaire to evaluate satisfaction with emergency care.The first phase included 517 patients, of whom 20 had acute pancreatitis. For amylase testing sensitivity was 0.70; specificity, 0.85; positive predictive value (PPV), 17; and negative predictive value (NPV), 0.31. For lipase testing these values were sensitivity, 0.85; specificity, 0.96; PPV, 21, and NPV, 0.16. When both tests were done, sensitivity was 0.85; specificity 0.99; PPV, 85; and NPV, 0.15. The second phase included data for 4815 patients, 118 of whom had acute pancreatitis. The measures of diagnostic yield for the new algorithm were sensitivity, 0.92; specificity, 0.98; PPV, 46; and NPV, 0.08].This study demonstrates a process for developing a protocol to guide laboratory testing in acute pancreatitis in the hospital emergency department. The proposed sequence of testing for pancreatic enzyme levels can be effective for diagnosing acute pancreatitis in patients with abdominal pain.Aplicar un ciclo de mejora continua (CMC) para la determinación de un algoritmo de solicitud de pruebas de laboratorio en el diagnóstico de la pancreatitis aguda (PA) en un servicio urgencias hospitalario (SUH).Estudio cuasiexperimental que aplicó la metodología CMC en dos fase consecutivas en pacientes atendidos en un SUH: en la primera se usaron la amilasa y lipasa para el diagnóstico de PA, y en la segunda solo la lipasa y solo si esta estaba en un rango determinado, se añadía automáticamente la amilasa. Se recogieron datos demográficos, número y valores de amilasa y lipasa, el diagnóstico final, y se realizó una encuesta de satisfacción a los médicos de urgencias.El primer ciclo incluyó 517 pacientes, 20 de ellos con PA. Las características de las pruebas diagnósticas fueron: amilasa [sensibilidad (Se): 0,70; especificidad (Es): 0,85; cociente de probabilidad positivo (CPP): 17 y cociente de probabilidad negativo (CPN): 0,31], lipasa (Se: 0,85; Es: 0,96; CPP: 21 y CPN: 0,16) y la determinación de ambas (Se: 0,85; Es: 0,99; CPP: 85 y CPN: 0,15). En el segundo ciclo se incluyeron 4.815 pacientes, de los cuales 118 sufrieron una PA. El nuevo algoritmo propuesto tuvo una Se: 0,92; Es: 0,98; CPP: 46 y CPN: 0,08.La elaboración de un protocolo de solicitud de marcadores de laboratorio y la estrategia secuencial de solicitud de enzimas pancreáticas pueden ser efectivas para diagnosticar PA en un SUH.

BACKGROUND Our aim is to study the regional variability in the request of thyroid laboratory tests from primary care facilities in Spain and to investigate a potential inappropriate request and its economic societal impact. METHODS Spain is divided into 17 autonomous communities (AACCs) which are in turn divided in Health Departments that cover a geographic area and its population and a laboratory that attends the needs of every inhabitant. Each participating laboratory was required to report the number of thyroid tests requested from primary care during year 2014 and to provide organizational data. The request of every test per 1000 inhabitants and ratio of related tests (free thyroxine (FT4)/thyrotropin (TSH), triiodothironine (FT3)/TSH, antithyroglobulin antibody (ATG)/antiperoxidase antibody (TPO)) were calculated and compared in different AACCs with more than 4 participants. The economic costs taking into account reagent cost were calculated. RESULTS 110 laboratories participated (27,798,262 inhabitants). Close to 6 million TSH tests were requested, representing an expense of more than 10 million euros. That corresponds to 18 million euros when extrapolating for the whole Spanish population, only in reagent cost. The number of TSH requests per 1000 inhabitants in the different AACCs ranged from 198 to 289. FT4 was ordered more than twice as frequently in some regions compared to others. TPO request per 1000 inhabitants ranged from 0.2 to 11.2. CONCLUSIONS There was a significant over-request and regional variability of thyroid laboratory tests in primary care in Spain, resulting in a high economic impact on society.

AimThe purpose of this study is, first to present a 10-year monitoring of postanalytical turnaround time (TAT) adapted to different clinicians and patient situations, second to evaluate and analyse the indicators results during that period of time, and finally to show a synthetic appropriate indicator to be included in the balanced scorecard management system.MethodsTAT indicator for routine samples was devised as the percentage of certain key tests that were verified before a specific time on the phlebotomy day. A weighted mean synthetic indicator was also designed. They were calculated for inpatients at 15:00 and 12:00 and for primary care patients only at 15:00. The troponin TAT of emergency department patients, calculated as the difference between the troponin verification and registration time, was selected as the stat laboratory TAT indicator.ResultsThe routine and stat TAT improved along the 10-year study period. The synthetic indicator showed the same trend.ConclusionsThe implementation of systematic and continuous monitoring over years, promoted a continuous improvement in TAT which will probably benefit patient outcome and safety.

Alerted by the high rates of request of serum uric acid (UA) in primary care patients, we aimed to design a strategy to improve such an indicator, and to monitor such an intervention through process and outcome appropriateness indicators.To design the strategy, several meetings were held between the Laboratory, Rheumatology and Primary Care. The intervention consisted of discharging UA from two laboratory profiles ("Health Check" and "Rheumatology"), making it only possible to request the test in an individualized manner. To assess the intervention effectiveness, the ratio of UA/glucose requests, the quantity of allopurinol prescription and the resulting economic savings were calculated and compared for pre- and post-intervention 12 month periods.There was a 70% decrease in the number of UA requests in the post-intervention period, as compared to the pre-intervention interval. The ratio of UA/glucose requests experienced a significant commensurate drop in the post-intervention period (p0.01). There was a significant reduction in the prescription of allopurinol (p0.01). From an economic perspective, the strategy resulted in a savings of 8190 €.The strategy resulted in a dramatic drop in the number of UA requests and in the prescription of allopurinol. This highlights a likely existence of prior unnecessary treatment of patients with hyperuricemia in the absence of clinical symptoms.

Background: The intent of this study was to investigate the requesting pattern of B-type natriuretic peptide (BNP) in the Emergency Department (ED) and the expenses associated with it. Methods: Clinical laboratories of the Spanish National Health System were invited to report the number of BNP requested in the ED during 2016. The number of BNP requested per 1,000 ED admissions was calculated, and compared between laboratories. Laboratories were divided in two groups; those where BNP could be freely requested in the ED (free availability group), and those where it was regulated by algorithms/internal policies. We calculated the costs based on the provided BNP reagent prices. Results: Sixty-five laboratories participated in the study. In 21 (32.3%) BNP was not offered in the ED. The median rate of BNP request per 1,000 ED admissions in the remaining 44 was 32.2 (IQR: 47.6). Twenty-three (52.3%) laboratories measured the BNP in the ED without any restriction. Twenty-one (17.7%) followed certain internal guidelines. The rate of request was lower in the former (21.4 vs . 47.9) (P=0.013). To measure a total of 154,702 BNP, 1,665,833€ were spent. If the demand in the free-availability group would have been the same as in the restricted-availability counterpart, 42,962 VNP requests could have been not measured, with potential savings of 462,615€. Conclusions: One third of laboratories did not offer BNP in the ED, despite current recommendations. Institutions with policies regulating the BNP request had a lower rate of requests that those with no such regulations. If the latter would have similar policies, more than 400,000€ could have been saved in reagent costs alone.