Search

BackgroundColorectal cancer (CRC) is a leading cause of cancer incidence and mortality. Screening can result in reductions in incidence and mortality, but there are many challenges to uptake and follow-up.ContentHere, we will review the changing epidemiology of CRC, including increasing trends for early and later onset CRC; evidence to support current and emerging screening strategies, including noninvasive stool and blood-based tests; key challenges to ensuring uptake and high-quality screening; and the critical role that clinical laboratories can have in supporting health system and public health efforts to reduce the burden of CRC on the population.SummaryClinical laboratories have the opportunity to play a seminal role in optimizing early detection and prevention of CRC.

The aim of the present study was to assess the effect of repeated laboratory measurement of C-reactive protein (CRP) and leukocyte count on the decision whether to admit or dicharge the patient with localized infections who received antibiotics at the Emergency Department (ED) observation unit.Adult patients with respiratory, urinary tract and abdominal infections, observed at the ED after antibiotic administration, in whom repeated measurements of CRP and leukocyte count were performed within 24 h, were included. They were initially grouped as planned discharge, planned admission and unclear attitude towards admission. Initial and repeated CRP and leukocyte count results, clinical dynamics (improvement, worsening, unchanged) and clinical decision about discharge or admission, were recorded.A total of 1,038 patients were eligible for inclusion. No significant differences in initial CRP and leukocyte count values were observed, nor any association of CRP and leukocyte count changes with clinical dynamics. Among 504 patients eligible for discharge at second laboratory sampling according to clinical dynamics, 54.4 % were further observed or admitted. Discharged patients had an average negative absolute (p<0.001) and relative CRP change (p=0.002). Clinical dynamics, first and second CRP results and absolute CRP change were independently associated with the decision to discharge or further observe/admit.Schematic repetitions of CRP and leukocyte count at the ED observation unit are common, regardless of patients’ clinical condition. Clinical judgment remains the main guiding factor to admit or discharge the patient, but repeated CRP testing influences the final decision, contributing to higher admission rates. [ABSTRACT FROM AUTHOR]

Objectives Informal payments (IPs) are unofficial cash or in-kind payments for goods or services that should be covered by the health care system. They are a common but regressive method of financing health care in low- and lower-middle-income countries (LMICs). This study aims to characterize the prevalence and impact of IPs on pathology and laboratory medicine (PALM) services. Methods From September 2021 to September 2022, PALM staff were surveyed about the frequency, determinants, and impacts of IPs in their respective workplaces. Results In total, 268 responses were received, and 46.6% (125/268) reported experience with IPs. These 125 participants were more likely to work in the public sector and in LMICs. Approximately 65% reported accepting IPs to perform tests or release results. Obtaining faster results was the most commonly perceived reason for patients offering IPs. Overall, participants reported that IPs had more negative than positive impacts on their workplace. Conclusions This represents a first step in characterizing IPs within PALM and how this practice may affect access to these services in LMICs. Specifically, the fact that faster turnaround time was the most frequently perceived reason for offering IPs uncovers a potential barrier to improving PALM capacity in these regions. [ABSTRACT FROM AUTHOR]

Critical test results in clinical laboratories are crucial for timely patient care, serving as indicators of potentially life-threatening conditions. Despite their importance, a notable heterogeneity in management practices exists globally. This study investigates the current practices of managing critical results at Danish clinical biochemistry laboratories and identifies areas prone for improvement. A comprehensive online survey was distributed to all 21 Danish clinical biochemistry laboratories regarding their critical result management, including documentation practices, critical limit selection, and quality assurance measures. A total of 17 laboratories (81%) responded. The answers revealed a generally uniform approach to managing critical results, with all laboratories having 24-h reporting, local instructions and using the telephone as communication channel. However, variations were noted in documentation practices and critical limit selection. Notably, 23.5% of the laboratories reported that one out of every ten critical results was not reported, indicating a significant risk of delayed critical results. This is further complicated by the limited use of predefined timeframes for reporting and also, only few laboratories actively monitored response times. The findings emphasize the need for more standardized documentation and evaluation practices to align with international standards and to enhance patient safety. While the laboratories showed a commitment to standardized procedures, the study emphasizes the necessity of a National or Nordic guideline to supplement the ISO 15189:2022. This study is a step towards optimizing critical result management, not only in Danish clinical biochemistry laboratories but also across various laboratory specialties, thereby improving overall laboratory quality, efficiency, and patient safety. [ABSTRACT FROM AUTHOR]

Objectives To measure rates of potentially inappropriate pathology testing in the hospital setting. Methods Retrospective cross-sectional study in hospital setting from July 2021 to December 2021. We examined 3 potentially inappropriate uses: overordering, selection errors, and unnecessary repeat testing. Overordering included vitamin D and lipids (rarely required in acute hospital care). Selection error was the ratio of iron studies to standalone ferritin requests. Unnecessary repeats included any repeat vitamin D, lipids, iron, or ferritin in an episode of care or C-reactive protein (CRP) repeated within 3 days and N-terminal pro–brain natriuretic peptide (NT-proBNP) within 7 days and repeated previously abnormal CRP and NT-proBNP tests. Costs of inappropriate tests were estimated using the Australian Medicare Benefits Schedules. Results Among 55,904 test requests, 15% (n = 8120) were potentially inappropriate. Vitamin D was frequently ordered (n = 4498), as were lipids (n = 2872). Ratio of iron studies to standalone ferritin was 36. Of 19,233 repeat CRPs, 36% (n = 6947) were within 3 days and 62% (n = 179) of repeat NT-proBNPs were within 7 days of the first test. For initially abnormal tests, 89% of CRPs and 97% of NT-proBNPs remained abnormal. Inappropriate test costs accounted for 12% to 30% of costs. Conclusions Frequent potential inappropriate use and selection of pathology tests was observed in South Australian hospitals. [ABSTRACT FROM AUTHOR]

Background: Non-secretory multiple myeloma is a sporadic type of multiple myeloma with the proliferation of monoclonal plasmocytes in the bone marrow that cannot secrete or synthesize immunoglobulins. Its prevalence as a hematologic malignancy is low, and it is usually diagnosed by demonstration of monoclonal plasma cells ≥ 10% in the bone marrow with negative results on serum and urine electrophoresis and immunofixation studies. Methods: We present a case report where the patient's serum and whole blood samples were received in the study laboratory to evaluate the complete hemogram and metabolic profile. The metabolic and hematological profiles were deranged, subsequent to which the patient's clinical history was obtained from the treating clinician. It was discovered that the patient had presented with long-term weakness and back ache and was advised routine investigations along with magnetic resonance imaging (MRI) of the spine, which revealed the presence of osteolytic lesions. Following this, a gammopathy panel was requested. Results: Serum protein capillary electrophoresis and immunofixation electrophoresis revealed a normal pattern without any noticeable bands, distortions, or suspicious regions. However, the findings of the comprehensive gammopathy panel were suggestive of non-secretory multiple myeloma. Conclusion: In the absence of a detailed and meticulous work-up, a case of non-secretory multiple myeloma can be easily misdiagnosed. Here, we discuss the case in detail, the diagnostic pitfalls associated with it, and the role of serum free light chain assays in its diagnosis.

The rapid acquisition of larg volumes of thin-section CT images has created a considerable need and interest for 3D postprocessing during the interpretation of medical imaging. As a result of the increasing number of postprocessing applications, requiring diagnostic radiologists to perform postprocessing is no longer realistic. This article is a comprehensive review of medical resources regarding establishing a postprocessing radiology laboratory. Besides, leadership and managerial aspects have been covered through a professional business lens. In large-volume settings, a dedicated 3D postprocessing lab ensures the quality, reproducibility, and efficiency of images. Adequate staffing is necessary to fulfill the postprocessing requirements. Educational and experience requirements for 3D technologists may vary among different running laboratories. To evaluate the establishment and running of a 3D lab, it is beneficial to implement diagnostic radiology cost-effectiveness tools. Although establishing a 3D lab has many benefits, certain challenges should be considered. Outsourcing or offshoring may serve as alternatives for establishing a postprocessing laboratory. Building and operating a 3D lab is a significant change in healthcare facilities, and it is crucial for organizations to be aware of the strong resistance toward alternatives the status quo, known as the status quo trap. The change process has essential steps, and skipping the steps creates an illusion of speed but never produces satisfactory results. The organization should ensure the engagement of all interested parties in the whole process. Moreover, a clear vision and proper communication of the vision are vital, and it is crucial to value small wins and ensure expectation clarity in leading the lab during the process. [ABSTRACT FROM AUTHOR]

Most reported cases of coronavirus disease 2019 (COVID-19) in children aged

Objective: To describe the frequency and characteristics of the use of Informed Consent (IC) for the use of biological samples from clinical care for research purposes in a Peruvian hospital. Setting: Northern Peru Hospital. Material and methods: Cross-sectional descriptive study developed during 2018, in 50 laboratory workers, through an interview using a questionnaire validated by 5 bioethic experts. Results: 30/50 were women; mean years of service: 6.5; 42% biologists, 30% medical technologists, and 25% technicians; according to academic degree: 46% Bachelor, 26% Master and 24% technicians; 24/50 reported training in ethics, being: 15/26 (talks), 8/26 (short courses) and 3/26 (graduates); 76% know of the need for IC to use samples; 78% and 64% of those surveyed explain the procedure to hospitalized patients and relatives of unconscious patients, respectively; 74% of those surveyed explain the sampling; 24% report that sometimes/almost always, "keep part of the sample" without the patient's IC; 52% do not explain to the patient/relative the confidentiality of the information; 44% state that they always/sometimes carry out "additional analyzes to those requested" with the sample. Conclusion: there are deficiencies in the ethical training of the respondents, and despite knowing the importance of the IC for the use of biological samples intended for clinical care, its use for research was evidenced. [ABSTRACT FROM AUTHOR]

Background: Non-secretory multiple myeloma is a sporadic type of multiple myeloma with the proliferation of monoclonal plasmocytes in the bone marrow that cannot secrete or synthesize immunoglobulins. Its prevalence as a hematologic malignancy is low, and it is usually diagnosed by demonstration of monoclonal plasma cells ≥ 10% in the bone marrow with negative results on serum and urine electrophoresis and immunofixation studies. Methods: We present a case report where the patient's serum and whole blood samples were received in the study laboratory to evaluate the complete hemogram and metabolic profile. The metabolic and hematological profiles were deranged, subsequent to which the patient's clinical history was obtained from the treating clinician. It was discovered that the patient had presented with long-term weakness and back ache and was advised routine investigations along with magnetic resonance imaging (MRI) of the spine, which revealed the presence of osteolytic lesions. Following this, a gammopathy panel was requested. Results: Serum protein capillary electrophoresis and immunofixation electrophoresis revealed a normal pattern without any noticeable bands, distortions, or suspicious regions. However, the findings of the comprehensive gammopathy panel were suggestive of non-secretory multiple myeloma. Conclusion: In the absence of a detailed and meticulous work-up, a case of non-secretory multiple myeloma can be easily misdiagnosed. Here, we discuss the case in detail, the diagnostic pitfalls associated with it, and the role of serum free light chain assays in its diagnosis. [ABSTRACT FROM AUTHOR]

Allergen-specific serum immunoglobulin E (sIgE) levels are a cornerstone in allergy diagnostics. While immunoglobulins are known to be relatively stable molecules, the influence of preanalytical factors on the stability of sIgE is not thoroughly investigated. We studied the effect of several preanalytical factors: (1) delayed centrifugation of serum samples in tubes with separating gel for 10, 24 and 48 h, (2) prolonged storage at 5 °C for 3, 7, 10 and 14 days, (3) storage tube type (primary tube with separating gel or secondary tube), (4) repeated freeze-thawing cycles, and (5) prolonged storage at −20 °C for 4 and 8 weeks. We found that sIgE is stable at room temperature for 48 h before centrifugation and for 10 days at 5 °C after centrifugation. There was no effect of the separating gel after storing serum for 1 week in the freezer. However, storage for 4–8 weeks, and introducing more than one freeze-thaw cycle resulted in a larger variation of sIgE levels. In conclusion, we found that sIgEs are stable under various preanalytical conditions, which allows for flexible handling of samples for a comprehensive portfolio of sIgE analyses. [ABSTRACT FROM AUTHOR]

COVID-19 pandemic caused by the newly emerged Coronavirus was first detected in China in December 2019 and rapidly spread throughout the world. With the rapid spread of the disease, all countries involved in accordance with their capacities took necessary measures to identify and manage the disease. The first patient was diagnosed with COVID-19 in Iran in February 2020. Considering the significant role of the laboratory services in detection and management of the disease, planning and programming to provide access to these services was considered as a top priority for healthcare system in Iran. Adopting all existing laboratory capacities and providing necessary infrastructures for expanding COVID-19 laboratory diagnostics, resulted in establishment of a nationwide network of COVID-19 molecular diagnostic laboratories within the shortest possible time. In addition to expanding the capacity of laboratory services, improving the laboratory network’s performance have been taken into serious consideration. In spite of the strict sanctions, the COVID-19 molecular diagnostic laboratories scaled up to more than 430 laboratories currently (September 2021), mostly are operating in the private sector. With considerable efforts, COVID-19 molecular laboratory network was established to provide nationwide diagnostic services. Taking into account the capacity for performing SARS CoV-2 Rapid Antigen testing, at the moment, we are able to provide more than 100,000 COVID-19 diagnostic tests per day. However, due to continuation of the pandemic and in accordance with the needs of the health system, it is necessary to plan and carry out more activities for diagnostic testing of COVID-19. The purpose of this paper is to introduce the process of establishing the COVID-19 laboratory diagnostic network to manage the COVID-19 pandemic in Iran.

Point-of-care testing is widely used in a variety of clinical settings. While this testing provides immediate and actionable clinical information, it is prone to error in both the interpretation and reporting of results. Point-of-care urinalysis presents unique opportunities for errors, ranging from variation in visual interpretation to input of results. The data included here represent the results from 63,279 urinalyses from 36,780 unique patients performed over a span of three years at an academic medical center and its associated clinics. The data include the patient age/legal sex, methodology (instrument and test strip used), and the available test results (color, clarity, glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocyte esterase). Additionally, we include the method of interface between the testing instrumentation and our electronic medical record (EMR). These fell into one of three broad categories: “Interfaced” (results directly transmitted from the urinalysis instrument to the EMR via specialized data interface), “Manual” (results input by selecting from a drop-down menu in the laboratory information system), and “Enter/Edit” (results typed freely into a text field in the EMR). Analysis of this data was primarily a direct comparison of detectable errors (typos, uninterpretable results, and results outside the reportable range) as a function of the method of entry into the EMR. Secondary analysis comparing the impact of restricting drop-down menu options for urine color and clarity was also performed. These data are of use to others as they are diverse in terms of the test performed and the method of interface. Others may wish to analyze these data when making decisions as to how to perform and report these tests and when estimating risks of error with various methods of data entry.

Objective Inappropriate laboratory test ordering is a significant and persistent problem. Many causes have been identified and studied. Medical laboratory professionals (MLPs) are technical staff within clinical laboratories who are uniquely positioned to comment on why inappropriate ordering occurs. We aimed to characterize existing MLP perceptions in this domain to reveal new or underemphasized interventional targets. Methods We developed and disseminated a self-administered survey to MLPs in Canada, including open-ended responses to questions about the causes of inappropriate laboratory test ordering. Results Four primary themes were identified from qualitative analysis: ordering-provider factors, communication factors, existing test-ordering processes, and patient factors. Although these factors can largely be found in previous literature, some are under-studied. Conclusion MLP insights into nonphysician triage ordering and poor result communication provide targets for further investigation. A heavy focus on individual clinician factors suggests that current understandings and interprofessional skills in the MLP population can be improved. [ABSTRACT FROM AUTHOR]

Background and objectives: The hoteling quality promotion is part of the health system development plan, based on which the physical appearance of laboratories of public hospitals are improved and renovated. The present study aimed to evaluate the policy-making gap in the hoteling quality promotion of the health system development plan in providing laboratory services in public hospitals in the Golestan Province, Iran. Methods: This descriptive-analytical and cross-sectional study was performed on 384 medical staff and physicians working in laboratories of public hospitals affiliated with the Golestan University of Medical Sciences, Golestan Province, Iran. Data were collected using a 35-item researcher-made questionnaire that was distributed and collected over a period of six months. We examined the extent of the gap between the current and expected status based on the two components: the alignment of key stakeholders with health system development policies and stakeholders' opposition to health system development policies, as well as the extent of the gap Results: The hoteling quality promotion was about -0.05 in providing laboratory services in public hospitals of the Golestan Province, indicating a low gap between the current and favorable status in the fifth axis of the health system development plan in terms of supervision. Conclusion: The implementation of the hoteling quality promotion plan in providing laboratory services in public hospitals of the province is not consistent with the expected goals of the fifth axis of the health system development plan. Therefore, there is a need to examine and eliminate effective factors contributing to this gap.

COVID-19 pandemic caused by the newly emerged Coronavirus was first detected in China in December 2019 and rapidly spread throughout the world. With the rapid spread of the disease, all countries involved in accordance with their capacities took necessary measures to identify and manage the disease. The first patient was diagnosed with COVID-19 in Iran in February 2020. Considering the significant role of the laboratory services in detection and management of the disease, planning and programming to provide access to these services was considered as a top priority for healthcare system in Iran. Adopting all existing laboratory capacities and providing necessary infrastructures for expanding COVID-19 laboratory diagnostics, resulted in establishment of a nationwide network of COVID-19 molecular diagnostic laboratories within the shortest possible time. In addition to expanding the capacity of laboratory services, improving the laboratory network's performance have been taken into serious consideration. In spite of the strict sanctions, the COVID-19 molecular diagnostic laboratories scaled up to more than 430 laboratories currently (September 2021), mostly are operating in the private sector. With considerable efforts, COVID-19 molecular laboratory network was established to provide nationwide diagnostic services. Taking into account the capacity for performing SARS CoV-2 Rapid Antigen testing, at the moment, we are able to provide more than 100,000 COVID-19 diagnostic tests per day. However, due to continuation of the pandemic and in accordance with the needs of the health system, it is necessary to plan and carry out more activities for diagnostic testing of COVID-19. The purpose of this paper is to introduce the process of establishing the COVID-19 laboratory diagnostic network to manage the COVID-19 pandemic in Iran. [ABSTRACT FROM AUTHOR]

Background: In public hospitals, the difficulties arising from the lack of logistical resources in the clinical laboratory make quality care even more difficult. The lack of management by processes and the conflicts of interest arising from the proliferation of laboratories that are not certified or accredited make a new vision on this subject necessary. Evidence-Based Laboratory Medicine is a tool from which clinicians, technologists and biologists can benefit. On the other hand, it is necessary that, from the state, the efforts made by the UNAGESP, IETSI, SIS, INACAL, SUSALUD, the Ombudsman's Office, the Comptroller General's Office of the Republic, professional associations and private companies to improve the management of the clinical laboratory be agreed upon. [ABSTRACT FROM AUTHOR]

The anion gap is a calculated parameter derived from the difference between the major plasma cations and anions in serum/plasma or whole blood, with a widely used simple equation utilizing concentrations of sodium, chloride, and bicarbonate. While there is extensive literature on the clinical significance and causes of elevated anion gaps, there is comparatively less data on low anion gaps. Occasionally, anion gap calculations result in a negative number (-1 or less). From the published literature, causes of these 'negative anion gaps' include laboratory error, specimen contamination or interference, hypoalbuminemia, extreme hyperkalemia, bromism, and paraproteins from multiple myeloma or similar pathologic processes. The data in this article present results from retrospective review of clinical chemistry and blood gas analysis testing at an academic medical center. The data include electrolyte concentrations and anion gap values derived from a total of 2,948,574 specimens (2,841,863 serum/plasma specimens analyzed on Roche Diagnostics clinical chemistry analyzers, 93,987 whole blood specimens analyzed on Radiometer blood gas analyzers, and 12,724 whole blood specimens on point-of-care chemistry devices) from 371,925 unique patients, clinical area where testing was ordered (for serum/plasma samples), sex, and age. For serum/plasma specimens with a negative anion gap, the data additionally include information from detailed chart review of possible factors and disease conditions contributing to the negative anion gap, pattern of electrolyte abnormalities, presence or absence of hypoalbuminemia, and corrected anion gap (if hypoalbuminemia is present).

Delays often occur between CLSI and FDA revisions of antimicrobial interpretive criteria. Using our Regional Healthcare Ecosystem Analyst (RHEA) simulation model, we found that the 32-month delay in changing carbapenem-resistant Enterobacteriaceae (CRE) breakpoints might have resulted in 1,821 additional carriers in Orange County, CA, an outcome that could have been avoided by identifying CRE and initiating contact precautions. Policy makers should aim to minimize the delay in the adoption of new breakpoints for antimicrobials against emerging pathogens when containment of spread is paramount; delays of

Background: Inappropriately repeated laboratory testing is a commonly occurring problem. However, this has not been studied extensively in the outpatient clinic after referral by GPs. Aim: The aim of this study was to investigate how often laboratory tests ordered by the GP were repeated on referral to the outpatient clinic, and how many of the normal test results remained normal on repetition. Design & setting: This is a post-hoc analysis of a study on laboratory testing strategies in patients newly referred to the outpatient clinic between April 2015 and April 2017. Method: All patients who had a referral letter including laboratory test results ordered by the GP were included. These results were compared with the laboratory test results ordered in the outpatient clinic. Results: Data were available for 295 patients, 191 of which had post-visit testing done. In this group, 56% of tests ordered by the GP were repeated. Tests with abnormal results were repeated more frequently than tests with normal results (65% versus 53%; P

Background and objectives: The hoteling quality promotion is part of the health system development plan, based on which the physical appearance of laboratories of public hospitals are improved and renovated. The present study aimed to evaluate the policy-making gap in the hoteling quality promotion of the health system development plan in providing laboratory services in public hospitals in the Golestan Province, Iran. Methods: This descriptive-analytical and cross-sectional study was performed on 384 medical staff and physicians working in laboratories of public hospitals affiliated with the Golestan University of Medical Sciences, Golestan Province, Iran. Data were collected using a 35-item researcher-made questionnaire that was distributed and collected over a period of six months. We examined the extent of the gap between the current and expected status based on the two components: the alignment of key stakeholders with health system development policies and stakeholders' opposition to health system development policies, as well as the extent of the gap Results: The hoteling quality promotion was about -0.05 in providing laboratory services in public hospitals of the Golestan Province, indicating a low gap between the current and favorable status in the fifth axis of the health system development plan in terms of supervision. Conclusion: The implementation of the hoteling quality promotion plan in providing laboratory services in public hospitals of the province is not consistent with the expected goals of the fifth axis of the health system development plan. Therefore, there is a need to examine and eliminate effective factors contributing to this gap. [ABSTRACT FROM AUTHOR]

Objectives: Corruption is a widely acknowledged problem in the health sector of low- and middle-income countries (LMICs). Yet, little is known about the types of corruption that affect the delivery of pathology and laboratory medicine (PALM) services. This review is a first step at examining corruption risks in PALM.Methods: We performed a critical review of medical literature focused on health sector corruption in LMICs. To provide context, we categorized cases of laboratory-related fraud and abuse in the United States.Results: Forms of corruption in LMICs that may affect the provision of PALM services include informal payments, absenteeism, theft and diversion, kickbacks, self-referral, and fraudulent billing.Conclusions: Corruption represents a functional reality in many LMICs and hinders the delivery of services and distribution of resources to which individuals and entities are legally entitled. Further study is needed to estimate the extent of corruption in PALM and develop appropriate anticorruption strategies. [ABSTRACT FROM AUTHOR]

Introduction: Given the relevance of quality-assured laboratory services for health system strengthening and improvement, this study had the objective of exploring the distribution of ISO 15189-accredited and non-accredited laboratories in Costa Rica, in order to identify possible gaps in the fulfillment of its commitment to provide ‘quality healthcare for all’. Methods: Our research was conducted with a descriptive scope and following a quantitative approach. Costa Rica’s Accreditation Body and College of Microbiologists databases were searched to collect data regarding clinical laboratory registration and ISO 15189 accreditation status. Laboratory availability indicators by geographical division were computed with this data. Results: Out of 480 clinical laboratories allowed to operate in Costa Rica as of January 2021, only 5 (about 1%) have been accredited in compliance with ISO 15189, all of which are private and located in the province of San José. Also, laboratory density (in terms of facilities per 100 km2 and per 100 000 population) is heterogeneous among provinces. Clinical laboratory services are more easily available in ‘central’ provinces of the country (e.g. San José and Heredia), where ratios for laboratory density are higher. On the contrary, coastal provinces such as Limón and Puntarenas exhibit low laboratory density ratios, reflecting geographical disparities in access to healthcare. Conclusions: Geographic disparities in the access to clinical laboratory services were observed. This should raise awareness among public health authorities and private healthcare providers regarding the country’s progress in attaining its ‘quality healthcare for all’ commitment.

Placement of pathology and laboratory medicine (PALM) services requires balancing efficiency (maximizing test volume) with equitable urban-rural access. We compared the association between population density (proxy for efficiency) and travel time to the closest facility (proxy for equitable access) across levels of Tanzania's public sector health system. We linked geospatial data for Tanzania from multiple sources. Data on facility locations and other geographic measures were collected from government and non-governmental databases. We classified facilities assuming increasing PALM availability by tier: (1) dispensaries, (2) health centres, (3) district hospitals and (4) regional/referral hospitals. We used the AccessMod 5 algorithm to estimate travel time to the closest facility for each tier across Tanzania with 500-m resolution. District-level average population density and travel time to the closest facility were calculated and presented using medians and interquartile ranges. Spatial correlations between these variables were estimated using the global Moran's I and bivariate Local Indicator of Spatial Autocorrelation, specifying a queen's neighbourhood matrix. Spatial analysis was restricted to 171 contiguous districts. The study included 5406 dispensaries, 675 health centres, 186 district hospitals and 37 regional/referral hospitals. District-level travel times were shortest for Tier 1 (median: [IQR]: 45.4 min [30.0-74.7]) and longest for Tier 4 facilities (160.2 min [107.3-260.0]). There was a weak spatial autocorrelation across tiers (Tier 1: -0.289, Tier 2: -0.292, Tier 3: -0.271 and Tier 4: -0.258) and few districts were classified as significant spatial outliers. Across tiers, geographic patterns of populated districts surrounded by neighbours with short travel time and sparsely populated districts surrounded by neighbours with long travel time were observed. Similar spatial correlation measures across health system levels suggest that Tanzania's health system reflects equitable urban-rural access to different PALM services. Longer travel times to hospital-based care could be ameliorated by shifting specialized diagnostics to more accessible lower tiers. [ABSTRACT FROM AUTHOR]

Objective To explore the experiences of medical laboratory professionals (MLPs) and their perceptions of the needs of clinical laboratories in response to COVID-19. Methods We surveyed laboratory professionals working in United States clinical laboratories during the initial months of the pandemic. Results Overall clinical laboratory testing and overtime work for laboratorians decreased during the first months of the pandemic. Laboratory professionals reported better or unchanged job satisfaction, feelings toward their work, and morale in their workplace, which were related to healthcare facility and laboratory leadership response. They reported receiving in-kind gifts, but no hazard pay, for their essential work. Important supply needs included reagents and personal protective equipment (PPE). Conclusion The response by healthcare facilities and laboratory leadership can influence MLPs job satisfaction, feelings toward their work, and laboratory morale during a pandemic. Current COVID-19 laboratory testing management, in the absence of sufficient reagents and supplies, cannot fully address the needs of clinical laboratories. [ABSTRACT FROM AUTHOR]

Background: Laboratory services play an important role in optimizing patient care today, and the importance of clinical laboratories is now widely accepted in medical practice. A critical value, originally described by Lundberg more than 30 years ago, refers to an abnormal test result that can lead to a serious life threat if not reported in a timely manner. In this study, we tried to determine the importance of critical values that can lead to a serious life threat with regard to their prevalence and frequency in laboratory tests of Iranian patients. Methods: In this cross-sectional study, the frequency of critical values in laboratory tests were determined and compared according to the type of laboratory parameter, age, sex, the inpatient/outpatient status, the related clinical ward, recurrence of critical values in the patient's test results, and the sampling working shift in Shahid Bahonar hospital in Kerman, Iran, in 2017 and 2018. Results: Among the tests, 0.2% had critical results. There was a significant relationship between the frequency of critical results with the patients' age (P = 0.002) and sex (P = 0.001) as well as with sampling working shift (P = 0.030) and admission ward (P = 0.001). Among the tests with critical values, the urea test was the most common with 32.2% critical value incidence. Conclusion: To maintain patient safety, proper recording of the results in laboratory tests and prompt reporting of critical values to the health care staff before repeating the test should be emphasized. [ABSTRACT FROM AUTHOR]

Introduction: The aim of the study was to investigate current practice and policies of therapeutic drug monitoring (TDM) service requesting and result reporting in Czechia and Slovakia. Materials and methods: All 149 laboratories that measure plasma drug concentrations were given an online questionnaire during a regular external quality assessment TDM cycle. The questionnaire consisted of 17 questions. The optimal TDM practice was defined as the application of all elements (age, body weight, time of sampling, date of the first administration, time of the last dose administration, the dose, the dosing interval, the route of administration, information on reason of testing, and information on other co-administered drugs) needed for reporting a recommendation for further drug dosing (positive response to question number 16). Results: The response rate was 69%, 103 out of 149 laboratories measuring drug concentrations. Only 12% (12 out of 103 laboratories) of the laboratories implemented all elements needed for optimal TDM practice and reported a recommendation. Both paper and electronic request forms were used by 77 out of 103 (75%) laboratories. A total of 69 out of 103 laboratories (67%) specified the type of sampling tube on their request form. Cystatin C was used for prediction of renal drug elimination by 24% (25 out of 103) of participants. Conclusions: Small number of laboratories implemented all elements needed for optimal TDM practice and report a recommendation on further dosing. Further efforts in education on optimal TDM practice as well as harmonization of service are desirable. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate testing turnaround time (TAT) and incision to close time in parathyroid surgeries before and after switching intraoperative parathyroid hormone (PTH) testing from a near point of care location to a central clinical laboratory. Design and Methods: This retrospective study covered a ten-year period. Both testing locations used the same Roche Diagnostics PTH immunoassay but on different analyzers. The predominant site for surgeries was the main operating rooms (ORs) in an adjacent building, with a limited number of parathyroid surgeries performed at a more distant ambulatory surgery center (ASC). Under ideal conditions, TAT for near point-of-care testing was 20 ​min, although multiple factors could increase TAT. Incision to close time from the electronic health record was used to define time of surgery. Results: A total of 897 unique patients were identified for which 3031 orders for intraoperative PTH were placed (383 unique patients and 1244 orders after switch in testing site). The average total TAT times for testing (mean ​± ​SD) in the central laboratory were 23.9 ​± ​16.0 ​min (median, 22 ​min) for all specimens, 22.8 ​± ​7.9 ​min (median, 21 ​min) for main OR specimens, and 26.4 ​± ​7.1 ​min (median, 25 ​min) for ASC specimens. Incision to close time for parathyroidectomies showed decreases in mean, median, and standard deviation following testing change. Conclusions: Surgery time for parathyroidectomies may remain consistent or decrease if intraoperative PTH testing is moved from a near point of care to a central laboratory.

Intraoperative monitoring of parathyroid hormone (PTH) is commonly used during parathyroidectomies. There are a number of practical challenges in achieving rapid turnaround time (TAT) for intraoperative PTH testing, whether the testing is performed point-of-care, near point-of-care, or in a central clinical laboratory. In the related research article, we analyzed a decade of data from 3025 intraoperative PTH tests on 897 unique patients. Of these, 1787 tests on 514 unique patients (375 female, 139 male) occurred while intraoperative PTH measurement was done as near point-of-care testing; the remaining 1238 tests on 383 unique patients (282 female, 101 male) occurred after a switch to intraoperative PTH measurement by the hospital central laboratory. The data in this article provides the patient age, gender, location of surgery (main operating rooms vs. ambulatory surgery center), incision to close time for surgery, and operation start to end times. For the central laboratory testing, additional data are provided for the intraoperative PTH TAT. The analyzed data is provided in the supplementary tables included in this article. Plots of operation start and end times are also included. The dataset reported is related to the research article entitled “Evaluation of Switch from Satellite Laboratory to Central Laboratory for Testing of Intraoperative Parathyroid Hormone” [D. Jacob, G. Lal, D.R. Voss, T. Bebber, S.R. David, J. Kulhavy, S.L. Sugg, A.E. Merrill, M.D. Krasowski, Evaluation of Switch from Satellite Laboratory to Central Laboratory for Testing of Intraoperative Parathyroid Hormone, Pract. Lab. Med. (2020) 22: e00176] [1]

Background: Customers’ satisfaction is imperative for success. Clinical laboratories continuously strive to attain very high levels of customer satisfaction to serve their clients and maintain accreditation. The concept of customer satisfaction has not yet been asserted in most clinical laboratories in Cameroon. Objectives: Our objectives were to assess the satisfaction of clinicians with the laboratory services at the Bamenda Regional Hospital Laboratory, identify important challenges, corrective actions implemented and changes in satisfaction. Methods: This retrospective study reviewed secondary data from clinician satisfaction survey records from March 2017 and November 2017. Challenges and implemented corrective actions were identified for assessed statements of dissatisfaction (dissatisfaction rates ≥ 20%) on the March 2017 survey. Satisfaction rates in March 2017 and November 2017 were compared. Results: High levels of dissatisfaction were observed for general satisfaction, waiting time, communication, duty consciousness, specimen collection and approach on the March 2017 survey. The main challenges identified were: lack of respect for the expected length of the waiting time, poor attitude, inadequate information, staff shortage and inadequate supervision. Statistically significant reductions in rates of dissatisfaction were observed for general satisfaction, waiting time, communication, response to emergencies, issuing of results, specimen collection, approach and duty consciousness. Conclusion: Waiting time is a major cause of clinician dissatisfaction with laboratory services. The identification of clinicians’ challenges and the effective implementation of corrective actions contribute to improvements in clinician satisfaction.

Background: Clinical laboratory workers are at permanent risk of suffering an occupational accident due to exposure to biohazard. These accidents may cause severe diseases, such as HIV, HBV or HCV. Objective: To describe the behavior of accidents due to occupational exposure to biohazard agents, and the characteristics of reports of occupational accidents in clinical laboratories in Yopal, Colombia. Material and methods: Observational descriptive study with exploratory component and retrospective analysis of incident report forms of presumed occupational accidents. Results: For the period between January 1, 2016, to December 31, 2018, an occupational accident percentage of 24.6 (95% confidence interval [95% CI], 16.7-32.5) was estimated, and an underreporting percentage of 39.3 (95% CI, 21.3-57.3). The main reasons for not reporting were a perceived lack of time (45.4%), and a diminished perception of risk exposure (36.4%). In contrast, factors associated with the probability of having less occupational accidents included being hired for service time (prevalence ratio [PR] = 0.19; 95% CI, 0.04-0.89; p = 0.034), and the permanent use of personal protective equipment (PR = 0.14; 95% IC, 0.02-0.88; p =0.036). Conclusion: Accident statistics in clinical laboratories prove the necessity to systematically reorganize risk management strategies that take into account human factor, organizational culture and control mechanisms. [ABSTRACT FROM AUTHOR]

Background Preanalytical errors account for most laboratory errors. Although the frequencies of preanalytical errors are well characterized in the literature, little is known regarding the costs of these errors to the laboratory. Objective To analyze costs associated with preanalytical errors associated with the international normalized ratio (INR) test. Methods We performed a retrospective analysis of INR requests associated with preanalytical error codes from January 2009 through September 2013. Preanalytical error types were those related to order entry (no specimen collected) and those unrelated to order entry (insufficient specimen quantity or specimen-integrity concerns). We calculated the cost of analysis of a specimen and the cost of investigating errors. Results During the study period, there were 557,411 INR requests, 13.1% of which were associated with a preanalytical error code. The total annual cost of INR testing was USD $379,222.50. Investigation and reporting of preanalytical errors not related to order entry represented 10.5% of our annual INR testing budget (USD $39,939.00). Conclusions Minimizing preanalytical errors has the potential to result in significant cost savings. [ABSTRACT FROM AUTHOR]

Copyright of Universidad Médica Pinareña is the property of Editorial Ciencias Medicas and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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 (<73.8 pmol/L). For patients included in the intervention, study demographic data, mean corpuscular volume (MCV) and hemoglobin values were collected. 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. [ABSTRACT FROM AUTHOR]

Background. In clinical practice it is often impossible to draw blood from peripheral veins for laboratory testing. At the same time the problem of comparison of venous and capillary blood parameters is still insufficiently studied. Aims. To compare 5 laboratory indicators of the thyroid gland function FT3 (free T3), FT4 (free T4), TgAb (thyroglobulin antibodies), TPOAb (thyroid peroxidase antibodies), and TSH in order to assess deviations of these parameters in venous against capillary blood. Materials and methods. The study enrolled 22 clinically healthy patients of both sexes who had their venous and capillary blood samples simultaneously collected in compliance with pre-analytical rules. The tests were performed within three hours of sample collection on the analyzer Roche Cobas e601. Mean values were calculated for all parameters using a 95% confidence interval based on bootstrap. Differences between paired values of venous and capillary blood parameters were calculated and expressed in relative units (%). Wilcoxon test and correlation analysis were used to compare dependent samples. Results. A statistically significant increase in capillary against venous samples was shown for FT3 (mean deviation 3.11; p 0.001), FT4 (3.89%, p 0.001), TgAb (2.73%; p = 0.041) and TPOAb (6.75%; p 0.001), and a decrease for TSH (-4.3%; p 0.001). A 5%-deviation is in most cases clinically insignificant for diagnosis and choosing a treatment. All the capillary blood parameters under study strongly correlate (r 0.75) with the same parameters of the venous blood: r = 0.971 for FT3; r = 0.993 for FT4; r = 0.958 for TgAb; r = 0.836 for TPOAb; r = 0.995 for TSH. Conclusions. Thus, FT3, FT4 and TSH can be determined in the capillary blood without affecting accuracy and precision of clinical evaluation, while for TgAb and TPOAb these deviations may be significant only when the results are in upper borderline values.

Rodas Getachew Abera, Boaz Arka Abota, Melese Hailu Legese, Abebe Edao Negesso Department of Medical Laboratory Sciences, School of Allied Health Sciences, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia Background: Monitoring patient satisfaction is an important and useful quality improvement tool for clinical laboratories in particular and health care organizations in general. Thus, this study aimed to assess patient satisfaction toward clinical laboratory services at Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia.Methods: A hospital-based cross-sectional study was conducted and a convenient sampling technique was applied to recruit study participants. A total of 210 patients who had received laboratory services were included. A self-administered predesigned, pretested, structured questionnaire was used, and data were collected through face-to-face interviews. A 5-point Likert scale with 1 and 5 indicating the lowest and highest levels of satisfaction, respectively, was used and their weighted average was used to categorize the satisfaction level of the patients. Chi square test was used (taking P≤0.05 as the statistically significant level) to find out if any association existed between the level of satisfaction and different attributes. Data were analyzed using SPSS version 20.Results: The overall level of patient satisfaction toward clinical laboratory services in this study was 59.7% with a response rate of 210 (100%). The Likert scale results of patient satisfaction of the laboratory services revealed that the mean rating values ranged from 3.05 (±1.12) to 4.12 (±1.08) out of a possible 5. Among the different indicators, patients were highly satisfied with the cleanliness of facility (82%), maintenance of privacy and confidentiality (83.2%), and the cost of the laboratory service (86.5%), while they were dissatisfied with the location of the laboratory (56%), latrine accessibility and availability (58.4%), and latrine cleanness and comfort (63.8%).Conclusion: The whole availability of requested tests, availability of place in blood drawing room to put personal things, and waiting time for specimen collection were found to have a statistically significant association with the overall satisfaction of patients toward clinical laboratory services. Therefore, these could be the possible determinants among others that account for the dissatisfaction of patients with clinical laboratory services. Keywords: patient satisfaction, hospital services, quality of care, referral hospital, Tikur Anbessa Specialized Hospital, Ethiopia

Background: Clinical chemistry tests are most widely used in clinical laboratories, and diverse measurement systems for these analyses are available in China. We evaluated the imprecision of clinical chemistry measurement systems based on internal QC (IQC) data., Methods: IQC data for 27 general chemistry analytes were collected in February each year from 2013 to 2022. Four performance specifications were used to calculate pass rates for CVs of IQC data in 2022. Boxplots were drawn to analyze trends of CVs, and differences in CVs among different groups were assessed using the Mann-Whitney U-test or Kruskal-Wallis test., Results: The number of participating laboratories increased significantly from 1,777 in 2013 to 5,425 in 2022. CVs significantly decreased for all 27 analytes, except creatine kinase and lipase. Triglycerides, total bilirubin, direct bilirubin, iron, and γ-glutamyl transferase achieved pass rates >80% for all goals. Nine analytes with pass rates <80% based on 1/3 allowable total error were further analyzed; the results indicated that closed systems exhibited lower CVs than open systems for all analytes, except total protein. For all nine analytes, differences were significant between tertiary hospitals and non-tertiary hospitals and between accredited and non-accredited laboratories., Conclusions: The CVs of IQC data for clinical chemistry have seen a continuous overall improvement in China. However, there is ample room for imprecision improvement for several analytes, with stricter performance specifications.

Proficiency testing (PT) is an impartial laboratory performance-evaluating system using an independent body. It is a mandatory accreditation requirement and means for improving the laboratory's performance. The study aimed to evaluate the performance of PT, with a focus on identifying and discussing determinants that influence PT performance at comprehensive specialized hospitals in northwest Ethiopia. A retrospective cross-sectional study was carried out from 2020 to 2022. Using a convenient sampling technique, laboratory tests with recorded PT results in each hospital laboratory were included. A data collection template and customized checklists were used to collect the data. Epi Data Version 3.1 for data entry and STATA Version 14.1 for cleaning and analysis were used. Binary logistic regression analyses were used. Variables with p < 0.05 in the multivariable logistic regression were considered to be statistically significant. Over nine cycles, 3807 PT challenges were distributed. The total failure rate of the laboratories was 32.4%, with a peak failure rate of 40.3% in 2020, after which the failure rate was decline to 20.6% in 2022. Among the five laboratory sections, molecular biology had the lowest failure rate (22.2%), while microbiology had the highest failure rate (56.5%). Multivariate logistic regression revealed that PT results reported without appropriate unit of measurement (AOR 7.5), lack of corrective action for PT nonconformance (AOR 7.1), and reagent unavailability (AOR 6.1) had significant effects on PT performance (p < 0.001). The results of this study showed that the overall performance of the laboratory was lower. Reporting PT results without appropriate units of measurement and not taking corrective action for PT nonconformance were the major aggravating factors for high failure rates., (© 2024. The Author(s).)

This paper is a description of the ICSH guidance for internal quality control (IQC) policy for blood cell counters. It follows from and links to a separate ICSH review for such policies and practices. The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers and a survey issued to 191 diagnostic laboratories in four countries (China, the Republic of Ireland, Spain, and the United Kingdom) on their IQC practice and approach to the use of commercial IQC materials. This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial control materials. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values, and action limits used with commercial control materials, and frequency of running commercial controls materials. These findings and their implications for IQC Practice are addressed in this guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories., (© 2024 John Wiley & Sons Ltd.)