Traceability is an important tool in the harmonization and standardization of reporting laboratory results, making them comparable across measurement systems. Driven by International Standardization Organization (ISO) 15189 accreditation requirements, medical laboratories have entered the era of metrological traceability. Although calibrators are a key component in the entire metrological traceability system, there is controversy over internal quality control (IQC) materials. It has been proposed that trueness materials supplied by the system\'s manufacturer with metrological traceability can be used to confirm that the performance of the measuring system is properly unbiased. This article focuses on the implementation challenges and operational hurdles of applying traceability concepts to IQC materials for trueness verification in medical laboratories regarding the most recent 2022 edition of ISO 15189 standard requirements for IQC and metrological traceability. There are practical considerations concerning the acquiring of IQC materials. We must acknowledge the limitations and restrictions that manufacturers and laboratories face before the recommendations can be applied in routine practices.
Sljedivost je važan alat za harmonizaciju i standardizaciju izvještaja o laboratorijskim rezultatima, čineći ih uporedivim u svim sistemima mjerenja. Vođene zahtevima za akreditaciju Međunarodne organizacije za standardizaciju (ISO) 15189, medicinske laboratorije su ušle u eru metrološke sledljivosti. Iako su kalibratori ključna komponenta u celom sistemu metrološke sledljivosti, postoje kontroverze oko materijala za internu kontrolu kvaliteta (IKK). Predloženo je da se materijali za istinitost koje je isporučio proizvođač sistema sa metrološkom sledljivošću mogu koristiti za potvrdu da su performanse mernog sistema ispravno nepristrasne. Ovaj članak se fokusira na izazove implementacije i operativne prepreke primene koncepata sledljivosti na IKK materijale za verifikaciju istinitosti u medicinskim laboratorijama u vezi sa najnovijim zahtevima standarda ISO 15189 za IKK i metrološku sledljivost iz 2022. godine. Postoje praktična razmatranja u vezi sa nabavkom IKK materijala. Moramo da priznamo ograničenja sa kojima se suočavaju proizvođači i laboratorije pre nego što se preporuke mogu primeniti u rutinskoj praksi.

Efficiency in oral pathological laboratory processes is paramount for timely and accurate diagnosis. This review explores various strategies and methodologies that help streamline oral pathological laboratory workflows to enhance productivity and reduce turnaround times. Key focus areas include specimen collection, handling, processing, and analysis. Optimization techniques such as automation, digitalization, and standardization are discussed in detail, emphasizing their role in minimizing errors and maximizing throughput. Additionally, the integration of advanced technologies such as artificial intelligence and machine learning is examined for their potential to improve laboratory operations. Moreover, the importance of quality control measures and compliance with regulatory standards is underscored as essential components of any successful laboratory streamlining initiative. By implementing a comprehensive approach that addresses the entire diagnostic pathway, oral pathological laboratories can achieve significant efficiency, ultimately leading to better patient care and outcomes.

Fine-needle aspiration (FNA) is a safe, cost-effective diagnostic procedure used in the evaluation of thyroid nodules. The number of thyroid FNAs has dramatically increased over the past few years. In the absence of standardized procedures regarding the number of needle passes needed for diagnosis and the lack of clarity on the use of conventional smears (CS) versus liquid-based preparations (LBP), the demand of thyroid FNAs has led to increased workload on cytology laboratories, which can negatively affect patient safety. We implemented a standardized two needle passes for CS and collection of all needle rinses and additional pass material in CytoRich Red for ThinPrep LBP and compared the non-diagnostic and diagnostic rates before and after this intervention. There were 290 pre-intervention cases and 348 post-intervention cases; of which, there were 17 (5.9%) non-diagnostic cases of the pre-intervention group and 27 (7.8) non-diagnostic cases of the post-intervention group. There was no statistically significant difference in non-diagnostic and diagnostic rates before and after the change (p = 0.347 by two-tailed Z test).

OBJECTIVE: We assessed properties of running averages for our hospital\'s most common chemistry analytes, for use in real-time patient-based quality control (PBQC). We determined whether there was dependence of any running averages on 24-h clock time (time-of-day, TOD).
METHODS: We analyzed 3-months\' data for measurements of 13 metabolic panel components. Running averages for 20 consecutive results (20-mers) were computed for data restricted to results within reference intervals. This produced an overall mean (X) and standard-deviation (SD) of 20-mers for each analyte. We then computed the average 20-mer result (Y) reported within 1-h bins across 24-hour clock time (t). Y(t) was regarded as having TOD-dependence if either nadir or apex values for |Y-X| exceeded 0.5 SD, occurring within a contiguous series of at least 4 Y(t) values on one side of the mean.
RESULTS: Seven analytes (albumin, aspartate aminotransferase, calcium, chloride, CO2, potassium, total protein) demonstrated TOD-dependence of running means for 20-mers.
CONCLUSIONS: At our hospital, TOD-dependence of running means was identified for 7 of 13 metabolic panel analytes. TOD-dependence is likely to be hospital-specific. Utilization of TOD-dependent targets for PBQC, rather than fixed targets, would be appropriate in these cases.

OBJECTIVE: Complete blood count and differential (CBC diff) is a common laboratory test that may be overused or misordered, particularly in an inpatient setting. We assessed the ability of a clinical decision support (CDS) alert to decrease unnecessary orders for CBC diff and analyzed its impact in the laboratory.
METHODS: We designed 3 CDS alerts to provide guidance to providers ordering CBC diff on inpatients at frequencies of daily, greater than once daily, or as needed.
RESULTS: The 3 alerts were highly effective in reducing orders for CBC diff at the frequencies targeted by the alert. Overall, test volume for CBC diff decreased by 32% (mean of 5257 tests per month) after implementation of the alerts, with a corresponding decrease of 22% in manual differentials performed (mean of 898 per month). Turnaround time for manual differentials decreased by a mean of 41.5 minutes, with a mean decrease of up to 90 minutes during peak morning hours.
CONCLUSIONS: The 3 CDS alerts successfully decreased inpatient orders for CBC diff and improved the quality of patient care by decreasing turnaround time for manual differentials.

Burkholderia pseudomallei is a Gram-negative saprophytic bacillus that causes melioidosis. The infection is endemic in South-East of Asia and Northern Australia. B. pseudomallei has been designated as bioterrorism agent and its manipulation should be done in a biological safety level 3 capability. Workers in laboratories may be accidentally exposed to B. pseudomallei before its identification, with a risk of laboratory-acquired melioidosis. We want to describe a case of melioidosis occurred in our hospital and its management at laboratory. The objective of this article is to provide guidance to microbiologists confronted with a suspicious case of B. pseudomallei on the management of the exposition. We report here a couple of microbiological arguments that can usually guide microbiologists towards presumptive identification of B. pseudomallei. This case report shows the importance of MALDI-TOF MS accurate databases to ensure accurate microbial identification and antibiotic prophylaxis adapted to individuals who were exposed. We also want to underline the importance of developing an effective strategy of prevention against any accidental exposure that can occur in a microbiological laboratory.

Free ionized calcium (fCa) is considered the gold standard for assessing calcium status in patients, but it is relatively expensive and is associated with several preanalytical and analytical error sources. We investigated the feasibility of using a reflex test that involves first measuring total calcium (tCa) and if out of reference range, then measure fCa, with expectation of reducing the number of fCa measurements. We used data from 1815 unique patients with concurrent measurement of fCa, tCa and albumin adjusted calcium (aCa). Patients were stratified by albumin level, and the association of fCa to tCa and aCa respectively was assessed with linear regression. The regression analysis showed the best linearity for tCa and aCa at albumin <35 g/L (R2: 0.80-0.90), and the poorest at albumin >40 g/L (R2: tCa 0.58; aCa 0.59). We examined the accuracy of hypo- and hypercalcemia classifications for tCa, aCa and the reflex test. aCa had more misclassifications of hypo- and hypercalcemia than tCa, with respectively 25% and 21%. Implementation of the reflex test would correct any false hypo- or hypercalcemia classified by tCa, leaving only false negative results corresponding to 9% of all tCa measurements. False negative results were on average 0.04 mmol/L above or below the reference range of fCa. Implementation of the reflex test reduces the number of fCa by 68% without major errors diagnosing hyper- or hypocalcemia.

OBJECTIVE: Analysis of laboratory value often lacks assessment of the laboratory\'s impact on quality of care. In this study, we aimed to determine the impact of bringing a heparin-induced thrombocytopenia (HIT) antibody assay in-house on a quality metric-patient hospital length of stay (LOS)-and assess any associated cost savings.
METHODS: A retrospective review of patient visits with a HIT antibody assay over a 7-year period determined the mean LOS in send-out vs in-house HIT antibody assay cohorts as well as cohorts of positive and negative results. Our systemwide mean LOS and metrics of acuity were analyzed. We performed a financial analysis of estimated cost savings.
RESULTS: We found a mean LOS reduction of 3.97 days in the in-house cohort, with no evidence of a systemwide LOS decrease or a decline in patient acuity. This reduction was largely driven by a reduction in LOS among patients with a negative assay result. We found an estimated total cost savings of $3.9 million and an estimated mean savings per patient of $7,305, despite escalating health care costs over time.
CONCLUSIONS: We demonstrated a reduction in LOS following the introduction of an in-house HIT antibody assay that cannot be attributed to either systemwide initiatives or reduced patient acuity and was driven largely by patients with negative assays. This reduction was associated with significant estimated cost savings.

With the recent COVID-19 pandemic, point-of-care testing has gained tremendous attention, particularly in acute care settings. The point-of-care testing landscape is rapidly expanding and being contemplated for any crucial test with a central laboratory turnaround time >25% of the clinical decision time. A typical point-of-care testing program within a large hospital system encompasses a multitude of operators utilizing a wide range of devices across multiple testing sites. Thus, managing a large point-of-care testing network remains a daunting task with challenges related to staffing, standardization, quality management, training and competency assessment, and data management. This review will focus on understanding the general organization as well as the roles and responsibilities of various point-of-care testing stakeholders in addressing these challenges. More importantly, it will discuss the strategies and best practices for effective point-of-care testing management based on consensus recommendations from professional societies as well as our experience at Texas Childrens Hospital.

OBJECTIVE: This study aims to evaluate the performance of two latest generation matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) systems in routine laboratory settings, focusing on turnaround time (TAT), time to results (TTR), hands-on time, and identification rate.
METHODS: We conducted a time and motion study on three workflow scenarios to simulate different laboratory settings. Overall, 618 bacterial isolates from a tertiary hospital\'s laboratory were processed using the VITEK MS PRIME (bioMérieux) and the MALDI Biotyper sirius (Bruker Daltonics) and their corresponding databases VITEK IVD Database 3.2 and MBT reference library 12.
RESULTS: The target preparation process showed no significant difference in TAT, but the Biotyper workflow had a shorter hands-on time by 3 to 6 min. In the measurement process, TTR was three to five times shorter for the Biotyper sirius while hands-on time was significantly shorter for VITEK MS PRIME (approximately 1.5 min per target). The identification rate without retesting was 97.9% for VITEK MS PRIME and 98.9% for Biotyper sirius. Both systems achieved 100% agreement at genus and 96.2% at species level.
CONCLUSIONS: Both systems exhibited excellent identification rates for routine bacterial isolates. Due to its high speed, the Biotyper sirius is suited for laboratories with high sample throughput and a workflow designed for processing larger batches. The VITEK MS PRIME, with its \"load and go\" system accommodating up to 16 targets, reduces hands-on time, making it a reasonable choice for laboratories with fewer identifications overall but a higher number of targets and a workflow designed for parallel processing on different workstations.