Clinical Laboratory Personnel Research Articles

Manually operated microtube automatic capper/decapper system for clinical laboratory and biological laboratory personnel

Polymerase chain reaction (PCR) is an effective method for diagnosing infectious diseases and has been the primary method throughout the novel coronavirus disease (COVID-19) pandemic. PCR tests (from specimen collection to result acquisition) involve sample pretreatment, nucleic acid extraction, and PCR procedure. Automating the pretreatment process is crucial to mitigate the risk of infection for workers and to reduce the likelihood of sample contamination-triggered misdiagnosis, particularly when handling centrifuge tubes, cryopreservation tubes, and microtubes. Robotic systems have been engineered to automate cell culture and PCR-based diagnosis, predominantly designed for use with screw-capped containers. However, this leaves a notable gap in automation solutions for microtubes equipped with press-type caps. To address this gap, we developed a versatile microtube capper/decapper system. On the other hand, many tasks of manual operation using microtubes, which are routinely conducted in clinical tests and biological experiments, are performed. Compared to screw-type caps for centrifuge and cryopreservation tubes, press-type caps for microtubes present a considerably higher risk of the worker's fingers contacting the inside of the cap and/or generating airborne droplets. Despite the risks of contamination and infection derived from the manual handling of microtube caps, which can compromise diagnosis/experiment accuracy and worker safety, devices for manually opening and closing microtube caps without direct contact remain lacking. Therefore, leveraging the technology from the developed versatile microtube capper/decapper system for laboratory automation, we created a manually operated microtube equipped with an automatic capper/decapper system tailored for personnel in clinical and biological laboratories.In this study, we first examined the required specifications and prerequisites for a manual microtube capper/decapper and clarified the operating methods, operating procedures, operation environment, device size, accompanying functions, etc. Based on the required specifications and preconditions, we proceeded with the mechanical and control design of the conceptual model, manufactured a prototype, and confirmed its basic functions and performance. The compliant to the required specifications and preconditions and the usefulness of the proposed manual microtube capper/decapper were validated through various experiments and demonstrations. Using the proposed microtube capper/decapper, even small-scale operations, which are challenging to streamline, can be performed nearly as efficiently as full manual operations. Although operation time was not reduced, the ability to open and close microtubes without manual contact is crucial for improving diagnostic and experimental accuracy and for reducing the burden on and enhancing the safety of laboratory personnel. Because microtubes are used in various clinical tests and biological experiments, we believe that the proposed system can markedly reduce the workload for personnel across numerous clinical and biological laboratories.

Invisible and undervalued: A qualitative study of laboratory workers' experiences and perceptions of laboratory strengthening in Sierra Leone.

The 2013-2016 West Africa Ebola outbreak highlighted the importance of laboratory capacity to outbreak response while also revealing its long-standing neglect. The outbreak prompted massive international investment into strengthening laboratory services across multiple healthcare settings. In this article, we explore hospital-based clinical laboratory workers' experiences and perceptions of their everyday working environment in Sierra Leone, and how recent investments in laboratory strengthening have shaped these. This qualitative study draws on in-depth interviews with eight laboratory workers and participant observation of laboratory practices at a tertiary referral hospital in Freetown between April 2019 and December 2019. Interview and observational data were coded and analysed using a reflexive thematic approach. The Ebola outbreak prompted international investments in automated devices, biosafety training, and a new dedicated infectious diseases laboratory. However, little investment was made in the infrastructure and supply systems needed to sustain routine laboratory work or keep machines functioning. Laboratory workers perceived their work to be under-recognised and undervalued by the government, hospital managers and clinical staff, a perception compounded by under-use of the hospital's laboratory services by clinicians. Understanding laboratory technicians' views, experiences, and priorities is essential to any sustainable laboratory-strengthening effort. Investments in personnel should match investments in technologies and infrastructure for outbreak response. This study contributes to an understanding of how clinical laboratory personnel in Sierra Leone view and experience their work, and introduces the concept of social invisibility to explain these experiences.

Bacteriological and molecular characterization of temperature- and CO2-dependent Streptococcus pneumoniae serotype 24F ST162 isolated from Japanese children.

Streptococcus pneumoniae serotype 24F is one of the most prevalent non-vaccine serotypes that causes invasive pneumococcal disease (IPD) in many countries, including Japan. This study aimed to analyze the bacteriological and molecular characteristics of serotype 24F sequence type (ST) 162, which has been increasingly isolated from pediatric patients with IPD in Japan recently. The examination of growth conditions, sequencing of genes associated with the CO2 dependence, and antimicrobial susceptibility testing at 35°C under 5% CO2 were performed for 10 isolates obtained from Japanese children with IPD caused by serotype 24F ST162. All isolates failed to grow at 35°C in ambient air; however, they showed growth at 30°C in ambient air and at 35°C under 5% CO2. Sequencing of murF involved in cell wall synthesis indicated that all isolates had a single amino acid substitution, MurFA179V. Additionally, all isolates were sensitive to penicillin G and resistant to trimethoprim-sulfamethoxazole. Furthermore, 25 non-capnophilic strains were obtained from all CO2-dependent isolates, and their murF sequences were compared. Thirteen of the 25 non-capnophilic strains displayed a different amino acid substitution, MurFV179A, whereas the other 12 presented the previously described MurFA179V. This suggests that a proportion of the CO2-dependent phenotype of serotype 24F ST162 may have been conferred by MurFA179V; however, the mechanism for the CO2 dependence of these isolates warrants further investigation. The CO2-dependent serotype 24F ST162 pneumococcal isolates shared common characteristics in terms of growth patterns, molecular basis, and antimicrobial susceptibility; therefore, future epidemiological trends of this clone must be closely monitored. IMPORTANCE We characterized Streptococcus pneumoniae serotype 24F sequence type (ST) 162 isolated from Japanese children with invasive pneumococcal disease (IPD). Owing to its highly invasive nature, serotype 24F is expected to be isolated from clinically significant cases. Serotype 24F ST162 isolates tested in the present study did not grow at 35°C in ambient air. Therefore, antimicrobial susceptibility testing using the broth microdilution method, which is usually conducted in ambient air, cannot be performed, posing a clinical challenge. Clinical practitioners and laboratory personnel should be aware of the epidemiological, bacteriological, and molecular characteristics of serotype 24F ST162. We believe that our findings can help diagnose and treat IPD caused by serotype 24F ST162, a serotype expected to become problematic in the post-13 valent pneumococcal conjugate vaccine era.

Laboratory Evaluation of Antithrombin, Protein C, and Protein S.

Thrombophilia is a complex disease process, clinically manifesting in various forms of venous thromboembolism. Although both genetic and acquired (or environmental) risks factors have been reported, the presence of a genetic defect (antithrombin [AT], protein C [PC], protein S [PS]) is considered three of the major contributing factors of thrombophilia. The presence of each of these risk factors can be established by clinical laboratory analysis; however, the clinical provider and laboratory personnel must understand the testing limitations and shortcomings associated with the assays for these factors to be able to ensure an accurate diagnosis. This article will describe the major pre-analytical, analytical, and post-analytical issues associated with the various types of assays and discuss evidence-based algorithms for analyzing AT, PC, and PS in plasma.

On-demand, remote and lossless manipulation of biofluid droplets

The recent global outbreaks of epidemics and pandemics have shown us that we are severely under-prepared to cope with infectious agents. Exposure to infectious agents present in biofluids (e.g., blood, saliva, urine etc.) poses a severe risk to clinical laboratory personnel and healthcare workers, resulting in hundreds of millions of hospital-acquired and laboratory-acquired infections annually. Novel technologies that can minimize human exposure through remote and automated handling of infectious biofluids will mitigate such risk. In this work, we present biofluid manipulators, which allow on-demand, remote and lossless manipulation of virtually any liquid droplet. Our manipulators are designed by integrating thermo-responsive soft actuators with superomniphobic surfaces. Utilizing our manipulators, we demonstrate on-demand, remote and lossless manipulation of biofluid droplets. We envision that our biofluid manipulators will not only reduce manual operations and minimize exposure to infectious agents, but also pave the way for developing inexpensive, simple and portable robotic systems, which can allow point-of-care operations, particularly in developing nations.

Interventions to Increasing Test Cancellation Rates in Blood Bank Based on a Multi-Year Review.

Apart from the wasted resource, canceled tests cause delay of test results thus affecting patient care. The study aimed to identify the reasons for the test cancellation of samples received in a blood bank laboratory and determine the improvement target. The study retrospectively reviewed the canceled tests in a blood bank laboratory of a hospital in Hail, Saudi Arabia, from January 2017 to December 2020. Records of the canceled test taken from the quality assurance database were utilized to identify the various reasons. A total of 2,017 (2.7%) test cancellations were recorded in the 4-year study period with increasing rates noted. The two primary reasons were specimen quality issues (61.9%) and problems related to test orders (33.9%). The main reason for test cancellation was clotted specimen (48.5%) followed by incorrect test order (15.6%) and duplicate test order (13.9%). Statistically, a significant difference exists between the annual rates and reasons of cancellation, X2 (6, n = 2,017) = 83.24, p < 0.001. Test cancellations due to various reasons remain a significant challenge for clinical laboratories. Detailed analyses on these major reasons can aid in displaying an effective approach to decrease the cancellation rates. Harmonization among inter-professional health workers concerning specimen collection and handling, and involving clinical laboratory personnel could minimize laboratory errors and avoid test cancellations.

DeepCOVIDNet: Deep Convolutional Neural Network for COVID-19 Detection from Chest Radiographic Images.

The novel Coronavirus Disease 2019 (COVID-19) is a global pandemic that has infected millions of people causing millions of deaths around the world. Reverse Transcription Polymerase Chain Reaction (RT-PCR) is the standard screening method for COVID-19 detection but it requires specific molecular-biology training. Moreover, the general workflow is difficult e.g. sample collection, processing time, and analysis expertise, etc. Chest radiographic image analysis can be a good alternative screening method that is faster, more efficient, and requires minimal clinical or molecular biology trained laboratory personnel. Early studies have shown that abnormalities on the chest radiographic images are likely to be the consequence of COVID-19 infection. In this study, we propose DeepCOVIDNet, a deep learning based COVID-19 detection model. Our proposed deep-learning model is a multiclass classifier that can distinguish COVID-19, viral pneumonia, bacterial pneumonia, and healthy chest X-ray images. Our proposed model classifies radiographic images into four distinct classes and achieves the accuracy of 89.47% along with a high degree of precision, recall and F1 score. On a different dataset setting (COVID-19, bacterial pneumonia, viral pneumonia) our model achieves the maximum accuracy of 98.25%. We demonstrate generalizability of our proposed method using 5-fold cross validation for COVID-19 vs pneumonia and COVID-19 vs healthy classification that also manifests promising results.

Assessment of Clinical Laboratory Personnel Protective Equipment Inventory Management During COVID-19 Pandemic in the Philippines

Introduction/ObjectiveCOVID-19 pandemic has brought a worldwide scarcity of personal protective equipment, which prompted medical technologists to explore the inventory management strategies, specifically the maintenance, conservation, and alternative use of personal protective equipment. The study aimed to assess the impact of these strategies on the personal protective equipment shortage in laboratories, as well as identify and describe the clinical laboratory supply and demand of personal protective equipment during the outbreak.Methods/Case ReportThe researchers utilized a quantitative survey involving one hundred thirty-six medical technologists working in an institution-based laboratory of Makati and Taguig City. The collated data were encoded in Microsoft Excel for descriptive statistics containing frequency distribution.Results (if a Case Study enter NA)27.9% of the respondents affirmed that they experienced a shortage of personal protective equipment in their workplace but most were unsure whether the contributing factors caused it. The respondents resorted to inventory management strategies to alleviate their lack of personal protective equipment. However, 41.9% and 38.2% of the respondents were undecided whether the efforts to conserve personal protective equipment and the supply management strategies were effective, respectively. Meanwhile, 40.4% of the respondents agreed that personal protective equipment alternatives can help in mitigating the demand for traditionally manufactured personal protective equipment.ConclusionNonetheless, they were able to utilize inventory management strategies in which they were unsure if conservation and maintenance of personal protective equipment were effective but affirmed with the competency of an alternative use for alleviation.

The Clinical Impact of Proteomics in Amyloid Typing

The Clinical Impact of Proteomics in Amyloid Typing

Distinctive COVID-19 manifestations and re-exposure to SARS CoV 2 in clinical laboratory personnel under regular monitoring by RT-PCR and serology

Clinical laboratory personnel (CLP) present a unique opportunity to investigate distinct forms of COVID-19 as they are under constant testing for SARS CoV 2 infection. SARS CoV 2 RNA and antibodies were routinely investigated over a 5-month period in 26 professionals from a clinical laboratory in RJ, Brazil. Of them, three (11.5%) CLP presented the following peculiar COVID-19 manifestations: 2/26 (7.7%) had SARS CoV 2 antibodies without RNA detection during the follow-up, with a possible re-exposure in one case, and 1/26 (3.8%) a confirmed reinfection with RNA detection, and possibly a third re-exposure. Based on a long follow-up of SARS CoV 2 infection in CLP, this study showed that cases of COVID-19 without RNA detection are not common, but it does indicate the risk of re-exposure after the fall of antibody levels. Although scarcely reported, the investigation of less frequent forms of COVID-19 is relevant, given the lack of knowledge of its impact on the pandemic.

The antinuclear antibody HEp-2 indirect immunofluorescence assay: a survey of laboratory performance, pattern recognition and interpretation

BackgroundTo evaluate the interpretation and reporting of antinuclear antibodies (ANA) by indirect immunofluorescence assay (IFA) using HEp-2 substrates based on common practice and guidance by the International Consensus on ANA patterns (ICAP).MethodParticipants included two groups [16 clinical laboratories (CL) and 8 in vitro diagnostic manufacturers (IVD)] recruited via an email sent to the Association of Medical Laboratory Immunologists (AMLI) membership. Twelve (n = 12) pre-qualified specimens were distributed to participants for testing, interpretation and reporting HEp-2 IFA. Results obtained were analyzed for accuracy with the intended and consensus response for three main categorical patterns (nuclear, cytoplasmic and mitotic), common patterns and ICAP report nomenclatures. The distributions of antibody titers of specimens were also compared.ResultsLaboratories differed in the categorical patterns reported; 8 reporting all patterns, 3 reporting only nuclear patterns and 5 reporting nuclear patterns with various combinations of other patterns. For all participants, accuracy with the intended response for the categorical nuclear pattern was excellent at 99% [95% confidence interval (CI): 97–100%] compared to 78% [95% CI 67–88%] for the cytoplasmic, and 93% [95% CI 86%–100%] for mitotic patterns. The accuracy was 13% greater for the common nomenclature [87%, 95% CI 82–90%] compared to the ICAP nomenclature [74%, 95% CI 68–79%] for all participants. Participants reporting all three main categories demonstrated better performances compared to those reporting 2 or less categorical patterns. The average accuracies varied between participant groups, however, with the lowest and most variable performances for cytoplasmic pattern specimens. The reported titers for all specimens varied, with the least variability for nuclear patterns and most titer variability associated with cytoplasmic patterns.ConclusionsOur study demonstrated significant accuracy for all participants in identifying the categorical nuclear staining as well as traditional pattern assignments for nuclear patterns. However, there was less consistency in reporting cytoplasmic and mitotic patterns, with implications for assigning competencies and training for clinical laboratory personnel.

A Review on the Clinical Laboratory Personnel in North Korea

북한과 남한은 임상검사실 인력구조에서 차이가 있다. 북한에서는 남한의 ‘임상병리사’에 해당하는 유사인력을 ‘실험의사(검사의사)’라고 호칭한다. 본 연구자들은 탈북 보건의료인의 증언을 바탕으로 한 선행연구를 고찰해 보면, 검사의사(laboratory doctor)의 신분은 의사(physician)와 준의(feldsher, physician assistant)일 것이라고 사료된다. 의사와 준의는 5.5년제 의학대학 및 3년제 의학전문학교에서 양성되고 있다. 북한의 보건의료인력체계는 남한의 경우처럼 보건전문가들의 전문영역별 업무나 교육, 자격 및 법률이 세분화되어 있지않다. 대한임상병리사협회는 한반도 통일을 대비하여 유관 단체와 함께 정책연구를 통해서 북한 임상검사인력에 대한 직제전문화 구축과 발전 방향을 상호 모색해야 할 것으로 사료된다.

International Multi-Site Clinical Validation of Point-of-Care Microchip Electrophoresis Test for Hemoglobin Variant Identification

Introduction: Nearly 24% of the world's population carry hemoglobin (Hb) gene variants, with the large majority of affected births occurring in low-income countries. The most prevalent structural Hb variants are the recessive β-globin gene mutations, βS or S, βC or C, and βE or E1. Hb S mutation is prevalent in sub-Saharan Africa and in Central India. Hb C is common in West Africa, and Hb E is common in Southeast Asia and in India. Homozygotes or compound heterozygotes with βS (e.g., Hb SS or SC) have sickle cell disease (SCD), a chronic sickling disorder associated with pain, chronic multi-organ damage, and high mortality. While Hb EE causes only a mild microcytic anemia, Hb E in combination with β-thalassemia can lead to transfusion dependent thalassemia. Though carriers are typically asymptomatic, they may pass the mutations to their offspring. Screening is needed so that these disorders can be diagnosed early and managed in a timely manner2. For example, in low-income countries, due to lack of nationwide screening and comprehensive care programs, up to 80% of babies born with SCD are undiagnosed and less than half of them survive beyond 5 years of age2. The unmet need for affordable, portable, accurate point-of-care tests to facilitate decentralized hemoglobin testing in resource-constrained countries is well-recognized 2,3. Here, we present international multi-site clinical validation results and high diagnostic accuracy of the 'HemeChip' (Fig. 1), an affordable, 10-minute point-of-care microchip electrophoresis test for identifying common Hb variants S, C, and E. Methods: Institutional Review Board approvals were obtained at each study site, and blood samples were collected as part of the standard clinical care. Tests were performed by local users, including healthcare workers and clinical laboratory personnel. 315 children (6 weeks to 5 years of age) were tested in Kano, Nigeria. Study participants were enrolled at three hospitals, Amino Kano Teaching Hospital, Murtala Mohammed Specialist Hospital, and Hasiya Bayero Pediatric Hospital. 124 subjects (7 weeks to 63 years old) were included in the study at Siriraj Thalassemia Center in Bangkok, Thailand. 298 subjects (8 months to 65 years old) were tested at a referral testing facility of ICMR-National Institute of Research in Tribal Health, located at Late Baliram Kashayap Memorial Medical College, Jagdalpur, Chhattisgarh, India. Blood samples were tested with both HemeChip and the standard reference methods, high performance liquid chromatography or cellulose acetate electrophoresis. Reference test results were not available to the HemeChip users. Similarly, HemeChip test results were not available to the users of the standard reference tests. Clinical validation studies presented here were performed with a fully functional, portable HemeChip prototype developed at Case Western Reserve University (Fig. 1A). A commercial product has been developed based on this technology by Hemex Health Inc. under the product name, GazelleTM(Fig. 1B). Results and Discussion: Among the total 768 tests performed with HemeChip in all test sites, 732 were valid tests, as defined by the Standards for Reporting Diagnostic Accuracy (STARD)4. HemeChip correctly identified all subjects with Hb SS, Hb SC, Hb AS, Hb AE, and Hb EE with 100% accuracy (Table 1). Nine subjects with normal Hb (Hb AA) were identified as HbSS in Nigeria. No subjects with disease were identified as normal or trait by HemeChip. Three subjects with compound heterozygous Hb Sβ-thalassemia (2 subjects with Hb Sβ+-thalassemia, 1 subject with Hb Sβ0-thalassemia) were identified as Hb SS. Sensitivity was 100% for all Hb types tested. Specificity was 98.7% for Hb SS versus other Hb types, and 100% for all other Hb types tested. HemeChip displayed an overall diagnostic accuracy of 98.4% in comparison to standard reference methods for the Hb variants tested in all clinical testing sites (Table 1). HemeChip is a versatile point-of-care system that enables affordable, accurate, decentralized hemoglobin testing in resource-limited settings.

SAT-613 Heterophile Antibody Interference Causing Elevated TSH Levels: A Challenging Diagnosis

Introduction Patients with persistently abnormal thyroid function tests despite increasing thyroid hormone supplementation should be investigated for several clinically important causes. We present an interesting such case in which widely fluctuating TSH measurements were caused by assay-interfering heterophile antibodies. Clinical Case A 57-year-old female with primary hypothyroidism was referred to our clinic for widely fluctuating TSH levels despite adjustment of levothyroxine dose. Indeed, her TSH levels over the previous year were as high as 24.56 μIU/ml (reference range 0.27-4.20) with normal or even elevated Free T4 (up to 1.64 ng/dl, reference range 0.70-1.48), but with no symptoms of hypo- or hyperthyroidism. Laboratory assessment at our institution revealed a TSH of 0.13 µIU/ml without change in the dose of levothyroxine since the prior measurement. It was assumed that the patient had trouble with medication compliance. Over the subsequent year, serial thyroid function tests (TFTs) done at an outside institution showed TSH elevated between 18-28 µIU/ml with elevated free T4 levels. Multiple possibilities were considered as the cause of discordant TFTs including poor compliance (although she denied missing any levothyroxine doses), thyroid hormone resistance syndrome, TSH producing tumor, interference from biotin supplementation and antibody interference. Upon further review, a pattern was evident in the TFTs, with marked elevations in TSH levels noted when labs were done locally, but normal or low TSH levels when done at our institution, raising the suspicion of interfering antibodies. The majority of commercially available TSH assays use an automated chemiluminescence system with two-site sandwich antibody assay. Antibodies including heterophile antibodies (human anti-mouse monoclonal antibodies or HAMAs), autoantibodies and rheumatoid factors can interfere with immunoassays. HAMAs are the most common cause of interference. Clinical laboratory personnel can employ several techniques to investigate potential antibody interference. In our case, the clinical pathologist ran the TSH assay with dilution analysis at our institution and showed a linear pattern, indicating no interference. However, a dilutional analysis of this same sample at the outside lab did not demonstrate dilutional linearity confirming the presence of an interfering antibody. Thus, the TSH values obtained at the outside institution were erroneous. The patient’s actual TSH was low at 0.21 µIU/ml, hence solving mystery of her discordant TFTs. Conclusion Interfering antibodies such as HAMAs should be suspected whenever thyroid function tests done at different laboratories conflict with each other, conflict with the clinical picture, or form an unusual pattern. Reference: N Bolstad et al. Best Pract Res Clin Endocrinol Metab. 2013; 27(5):647-61

Clinical Laboratory Personnel Workforce Survey in Montana

<h3>ABSTRACT</h3> <h3>INTRODUCTION:</h3> The medical laboratory professional workforce shortage in the United States has been documented through several national survey reports that also describe the use of temporary staffing to fill vacancies. The primary study objectives were to determine the extent of the workforce shortage in Montana and describe the usage of temporary staffing to fill vacancies. <h3>STUDY OBJECTIVES:</h3> The study objectives were as follows: (1) identify Montana Clinical Laboratory Improvement Amendments laboratories by geographical area classification, (2) identify usage of temporary medical laboratory professionals based on laboratory type, (3) determine wage differences between full-time/part-time permanent employees versus temporary medical laboratory professionals, (4) determine the usage rates of temporary medical laboratory professionals, (5) identify the cause(s) for usage of temporary staffing, and (6) determine the length of time to fill vacancies. <h3>METHOD:</h3> An electronic survey composed of multiple-choice, dichotomous, short-answer, and open-ended questions was developed to collect qualitative and quantitative data and was distributed via email. <h3>RESULTS:</h3> The survey was sent to 83 facilities, with a 54% (<i>n</i> = 45) response rate. Of respondents, 49% (<i>n</i> = 22) reported employing temporary staffing, and 51% (<i>n</i> = 23) do not employ temporary staffing. The reasons for hiring temporary staffing included being unable to fill the position (62%), medical leave (13%), vacation (10%), and other reasons, such as deployment, maternity leave, being short-staffed, and administrative projects (15%). Of the 22 facilities employing temporary staffing, 45% (<i>n</i> = 10) have a temporary staffing budget line item. <h3>CONCLUSION:</h3> The survey results indicated there is a medical laboratory professional shortage in Montana, and compared with the national rate, the usage of temporary staffing is higher, and vacancies take longer to fill by up to 2 years. The usage of temporary staffing is more than twice as high compared with national survey rates. The state-specific data obtained from this study provided vital information to the Montana clinical laboratory community and could serve as an impetus to work collaboratively to explore solutions to the shortage based on state-specific needs. The survey design can also serve as an example for other states to conduct similar studies to gather state-specific information versus national survey aggregate data.

Impact of Reflex Algorithms on Urine Culture Utilization

Urine culture is the gold standard for the diagnosis of urinary tract infection (UTI), one of the most common causes of bacterial infection. As such, urine specimens are responsible for a major share of the workload in clinical microbiology laboratories. The inclusion of metrics, such as the catheter-associated UTI (CAUTI) rate, that factor into hospital reimbursements and concerns surrounding the attrition of clinical laboratory personnel have prompted scrutiny of urine culture utilization in many organizations. One strategy to improve urine culture management is the institution of urine reflex algorithms that restrict urine culture to specimens with evidence of inflammation on urinalysis. The high negative predictive value of indicators of pyuria and bacteriuria on urinalysis are useful to rule out UTI and thus the need for culture. Data from several studies support the notion that use of reflex criteria reduces urine culture utilization. However, few studies have examined the impact of reflex algorithms on CAUTI rates and antibiotic use. This article provides an overview of the laboratory diagnosis of urinary tract infections with a focus on the utility of urinalysis and reflex testing algorithms.

Morbidity profile among clinical laboratory personnel in a private tertiary care hospital in Bengaluru, South India

Morbidity profile among clinical laboratory personnel in a private tertiary care hospital in Bengaluru, South India

Optimal use of Rapid Diagnostics in Infection Control and Prevention

Clinical laboratories have implemented rapid diagnostic tests (RDTs) for the identification of bacterial pathogens, with subsequent improvements in antimicrobial stewardship, but these tests may also have a role in infection prevention. Early identification of pathogens by RDTs should allow faster implementation of infection prevention strategies with the goal of reducing transmission. In this review, we assess the use of RDTs as an infection control tool by exploring their role in screening, as well as diagnosis, of methicillin-resistant Staphylococcus aureus (MRSA), carbapenem-resistant gram-negative organisms, Clostridium difficile, and Mycobacterium tuberculosis. This assessment highlights the fact that implementation of RDTs to improve infection prevention will require ongoing collaboration between clinical laboratory personnel, infection prevention departments, and clinicians.

Showcasing the Possible: Mass Spectrometry Onsite Workshop Enhances Adoption of the Technology.

Mass spectrometry has gained a tremendous amount of interest in the clinical community in recent years, since it has become an essential platform in the clinical laboratory, providing vital and reliable results to enhance patient care. However, the scientists, technicians, and physicians associated with traditional clinical laboratories are not always familiar with this technique. Hence, implementation of mass spectrometry technology has generated a lot of apprehension. Great effort has been devoted to educating and training clinical laboratory personnel in both the technology and its applications. The AACC, in conjunction with the newly established Mass Spectrometry and Separation Sciences (MSSS)3 Division, has played an essential role in providing the necessary knowledge through the AACC annual conference, webinars, online certificate programs, and the AACC/MSSS conferences. Another mechanism, a mass spectrometry workshop, was introduced this year to further enhance the training and education in this field. The inaugural workshop took place on the last day of the 2016 AACC annual conference at the Perelman School of Medicine at the University of Pennsylvania (Fig. 1). The following month, two additional workshops occurred: one at the University of Chicago Medicine and one at …

Development of a postgraduate year 2 pharmacy residency in clinical pharmacogenetics.

The structure and development of an innovative, ASHP-accredited postgraduate year 2 (PGY2) clinical pharmacogenetics residency program are described. A 12-month PGY2 clinical pharmacogenetics residency was created at St. Jude Children's Research Hospital in accordance with the ASHP standards for advanced practice residencies. The purpose of this 12-month residency program is to prepare pharmacy residents to implement pharmacogenetics in clinical practice. The program helps residents develop expertise in the science of pharmacogenetics as well as an understanding of translational research, innovative pharmacy practice model development, and clinical informatics. The resident learns to optimize patient outcomes through the expert provision of evidence-based, patient-centered precision medicine as an integral part of an interprofessional team. After completing the program, residents are expected to have the clinical skills necessary to practice in the field of clinical pharmacogenetics and independently implement pharmacogenetic testing in other health-system settings. Because implementation of pharmacogenetics requires collaboration across many disciplines, residents works within an interprofessional team of physicians, nurses, informatics specialists, pharmacists, and clinical laboratory personnel to achieve program goals. Since the first resident graduated in 2012, the program has graduated 1 resident each year. Graduated residents have accepted pharmacogenetics positions at major academic medical centers and community hospitals, as well as academic and research positions with a pharmacogenetics emphasis. A PGY2 clinical pharmacogenetics residency was successfully developed at St. Jude in 2013. After completion of the program, residents are equipped with the clinical skills and necessary experience to drive precision medicine forward and lead the implementation of pharmacogenetic testing in other healthcare settings.