Laboratory reflex testing strategy for the early identification of primary care patients with multiple myeloma.

OBJECTIVES: Our objective was to shorten the screen for multiple myeloma (MM), through reflex testing. DESIGN AND METHODS: The clinical laboratory in the public University Hospital of San Juan (Alicante, Spain), serves 234,551 inhabitants. Through an intervention agreed with general practitioners, the Laboratory Information System (LIS) automatically registered serum immunoglobulins (Ig) when serum total proteins (STP) > 80 g/L for the first time in primary care patients. When concomitantly one Ig presented a value above and one below its reference interval, the LIS automatically registered a serum protein electrophoresis (SPEP). When a monoclonal peak in SPEP, immunofixation electrophoresis (IFE) for the typification of monoclonal bands (MB) was performed. If MB were present, a comment in the report explained the intervention. The number of additionally registered Ig, SPEP, IFE, and new diagnosis of MM were counted. The number of days elapsed from the report of elevated STP result to the final MM diagnosis was also counted as median and interquartile range (IQR), and compared to a pre intervention period. RESULTS: 2071 cases of hyperproteinemia were identified, and had 91 a monoclonal peak, confirmed by IFE. In 35 patients it was a new finding, and 9 were diagnosed with MM, 3 Waldestrom macroglobulinemia, 2 lymphoplasmacytic lymphoma and 21 monoclonal gammopathy of undetermined significance. The number of days elapsed from hyperproteinemia to diagnosis was lower in the intervention period (21.5 vs 119.4) (P < 0.01). As our results show, in addition to shortening the time to diagnosis, an increased rate of detection of plasma cell disorders was observed when using our algorithm. CONCLUSIONS: The above laboratory interventions agreed with clinicians, making use of laboratory technology resulted in early identification of MM.

Double positivity for rheumatoid factor and anti-CCP autoantibodies: improving referral from primary care of patients suspected of having rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic progressive autoimmune inflammatory disease with significant morbidity and mortality. The course of the disease can be modified if diagnosis is early and treatment appropriate. AIM: In this study, we aimed to evaluate a new strategy for early identification of RA patients in primary care settings (the 'diagnostic bottleneck') based on serological biomarkers and to manage inappropriate rheumatoid factor (RF) laboratory test requests. METHOD: A two-arm study was carried out. The first arm corresponded to a retrospective observational descriptive study of patients referred for RF testing from primary care using the current laboratory workflow. The second arm included the following prospective interventions: cancelation of RF requests corresponding to patients with previous negative results for RF over a one-year period; and automatic reflex testing antibodies against cyclic citrullinated proteins (anti-CCP) for patients displaying RF values >30 IU/ml. Outcomes from both arms were then compared. FINDINGS: As double positivity for RF and anti-CCP notably increases the positive likelihood ratio of RA. The intervention enabled a reduction of 2813 tests in 22 months. Moreover, the frequency of unnecessary referrals was reduced from 22% to 8.2%, while that of missed patients decreased slightly (from 21% to 16%), with the number of patients diagnosed per RF request remaining unchanged. In terms of costs, we saved 19.4 RF tests per anti-CCP test added.We developed a simple and cost-effective strategy for reducing the time to diagnosis of RA that can improve patients' quality of life. This approach was supported by primary and specialised care.

Clinical Decision Support System in laboratory medicine.

Clinical Decision Support Systems (CDSS) have been implemented in almost all healthcare settings. Laboratory medicine (LM), is one of the most important structured health data stores, but efforts are still needed to clarify the use and scope of these tools, especially in the laboratory setting. The aim is to clarify CDSS concept in LM, in the last decade. There is no consensus on the definition of CDSS in LM. A theoretical definition of CDSS in LM should capture the aim of driving significant improvements in LM mission, prevention, diagnosis, monitoring, and disease treatment. We identified the types, workflow and data sources of CDSS. The main applications of CDSS in LM were diagnostic support and clinical management, patient safety, workflow improvements, and cost containment. Laboratory professionals, with their expertise in quality improvement and quality assurance, have a chance to be leaders in CDSS.

Reporting age-adjusted D-dimer cut-off values reduces radiology overuse in emergency department patients with suspected deep venous thrombosis.

INTRODUCTION: Venous thromboembolism (VTE) is a leading cause of death, associated with substantial morbidity in the absence of treatment. Our aim was, first, to compare the diagnostic performance of D-dimer for the diagnosis of VTE in the emergency department (ED), when reporting conventional cut-off point versus when additionally reporting age-adjusted values. Second, we explored the ordering pattern of Doppler ultrasound (US) and computerized tomographic pulmonary angiogram (CTPA), before and after reporting of the aforementioned age-adjusted cut-off value. MATERIALS AND METHODS: We conducted a cross-sectional study to compare the diagnostic performance of D-dimer as a screening for VTE when reporting the conventional cut-off value versus when additionally including the age-adjusted metrics, and a quasi-experimental study to explore the ordering of Doppler US and CTPA before the age-specific metrics were shared in the report in ED patients between 50 and 100 years-old with D-dimer ordering. RESULTS: The cross-sectional study included 392 patients, 25 with VTE. The specificity using an age-adjusted cut-off value was significantly higher (0.51) compared to a single absolute cut-off (0.42), and the negative likelihood ratio was lower as well (0.08 vs. 0.19), but again not statistically significant. In the quasi-experimental study, there was a decrease in the rate of use of both CTPA and Doppler US (P < 0.05). CONCLUSION: The intervention improved the use of the D-dimer result in the ED and helped improve the request for imaging tests.

Clinical Decision Support systems: A step forward in establishing the clinical laboratory as a decision maker hubA CDS system protocol implementation in the clinical laboratory.

Background: New tools for health information technology have been developed in recent times, such as Clinical Decision Support (CDS) systems, which are any digital solutions designed to help healthcare professionals when making clinical decisions. The study aimed to show how we have adopted a CDS system in the San Juan de Alicante Clinical Laboratory and facilitate the implementation of our protocol in other clinical laboratories. We have user experience and the motivation to improve healthcare tools. The improvement, measurement, and monitoring of interventions and laboratory tests has been our motto for years. Materials and methods: A descriptive research was conducted. All stages in the design of the project are as follows: 1. Set up a multidisciplinary workgroup. 2. Review patients' data. 3. Identify relevant data from main sources. 4. Design the likely outcomes. 5. Define a complete integration scenario. 6. Monitor and track the impact. To set up this protocol, two new software systems were implemented in our laboratory: AlinIQ CDS v8.2 as Rule Engine, and AlinIQ AIP Integrated Platform v1.6 as Business Intelligence (BI) tool. Results: Our protocol shows the workflow and actions that can be done with a CDS system and also how it could be integrated with other monitoring systems, as well as some examples of KPIs and their outcomes. Conclusions: CDS could be a great strategic asset for clinical laboratories to improve the integration of care, optimize the use of laboratory tests, and add more clinical value to physicians in the interpretation of results.

Laboratory Strategies to Improve Allergy First-Line Screening in Primary Care.

BACKGROUND: There are nonestablished protocols in use for first-line allergy screening based on IgE testing. These protocols attempt to address an unmet need for sustainability of clinical laboratories, at a time when demand is increasing. OBJECTIVE: To present a novel protocol for first-line allergy screening and to evaluate the implementation benefits for patients, the health care system, and payers. METHODS: We carried out an observational retrospective study analyzing 4359 interventions on primary care testing requests. Interventions included overriding redundant serum IgE (sIgE) testing for allergen mixes, extracts included in mixes, low-prevalence extracts, and milk and egg molecular components without previous positive results when exposed to extracts. We also added prevalent allergen testing. RESULTS: The strategy saved 683 tests from being performed unnecessarily. Test volume decline was primarily driven by the cancelation of 2186 egg and milk components tests; 561 tests were added for mixes, together with 942 allergen extracts tests. DISCUSSION: The results of this study show how the allergy laboratory plays a key role in actively managing demand for sIgE testing, leading to optimized diagnosis.

Stat Laboratory Interventions to Improve Patient Management in the Emergency Department and Resource Expenditure: A 10-Year Study.

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.

CONUT: a tool to assess nutritional status. First application in a primary care population.

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<0.01) and over 65 (p<0.01). Detected cases of malnutrition were all mild, except 48 patients (4.9%) with moderate, and one (0.1%) with severe risk. The percentage of patients at risk of malnutrition was not significantly different among PCC, with the exception of one with patients at lower malnutrition risk. 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.

Laboratory parameters in patients with COVID-19 on first emergency admission is different in non-survivors: albumin and lactate dehydrogenase as risk factors.

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.

Less is more: Two automated interventions to increase vitamin B12 measurement when long-term proton pump inhibitor and decrease redundant testing.

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 < 200 pg/mL), examined the number of tests needed to detect a new case and investigated the economic cost of each one identified by the intervention. Additionally, we counted the s-vitamin B12 that were requested but not measured, and calculated the savings in reagent. 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.