Strengthening Antimicrobial Resistance Diagnostic Capacity in Rural Rwanda: A Feasibility Assessment.

Introduction: Antimicrobial resistance (AMR) is a global public health threat. Worse still, there is a paucity of data from low- and middle-income countries to inform rational antibiotic use. Objective: Assess the feasibility of setting up microbiology capacity for AMR testing and estimate the cost of setting up microbiology testing capacity at rural district hospitals in Rwanda. Methods: Laboratory needs assessments were conducted, and based on identified equipment gaps, appropriate requisitions were processed. Laboratory technicians were trained on microbiology testing processes and open wound samples were collected and cultured at the district hospital (DH) laboratories before being transported to the National Reference Laboratory (NRL) for bacterial identification and antibiotic susceptibility testing. Quality control (QC) assessments were performed at the DHs and NRL. We then estimated the cost of three scenarios for implementing a decentralized microbiology diagnostic testing system. Results: There was an eight-month delay from the completion of the laboratory needs assessments to the initiation of sample collection due to the regional unavailability of appropriate supplies and equipment. When comparing study samples processed by study laboratory technicians and QC samples processed by other laboratory staff, there was 85.0% test result concordance for samples testing at the DHs and 90.0% concordance at the NRL. The cost for essential equipment and supplies for the three DHs was $245,871. The estimated costs for processing 600 samples ranged from $29,500 to $92,590. Conclusion: There are major gaps in equipment and supply availability needed to conduct basic microbiology assays at rural DHs. Despite these challenges, we demonstrated that it is feasible to establish microbiological testing capacity in Rwandan DHs. Building microbiological testing capacity is essential for improving clinical care, informing rational antibiotics use, and ultimately, contributing to the establishment of robust national antimicrobial stewardship programs in rural Rwanda and comparable settings.

An Initiative to Decrease Laboratory Testing in a NICU.

BACKGROUND AND OBJECTIVES: Laboratory testing is performed frequently in the NICU. Unnecessary tests can result in increased costs, blood loss, and pain, which can increase the risk of long-term growth and neurodevelopmental impairment. Our aim was to decrease routine screening laboratory testing in all infants admitted to our NICU by 20% over a 24-month period. METHODS: We designed and implemented a multifaceted quality improvement project using the Institute for Healthcare Improvement's Model for Improvement. Baseline data were reviewed and analyzed to prioritize order of interventions. The primary outcome measure was number of laboratory tests performed per 1000 patient days. Secondary outcome measures included number of blood glucose and serum bilirubin tests per 1000 patient days, blood volume removed per 1000 patient days, and cost. Extreme laboratory values were tracked and reviewed as balancing measures. Statistical process control charts were used to track measures over time. RESULTS: Over a 24-month period, we achieved a 26.8% decrease in laboratory tests performed per 1000 patient days (∽51 000 fewer tests). We observed significant decreases in all secondary measures, including a decrease of almost 8 L of blood drawn and a savings of $258 000. No extreme laboratory values were deemed attributable to the interventions. Improvement was sustained for an additional 7 months. CONCLUSIONS: Targeted interventions, including guideline development, dashboard creation and distribution, electronic medical record optimization, and expansion of noninvasive and point-of-care testing resulted in a significant and sustained reduction in laboratory testing without notable adverse effects.

Impact of the COVID-19 pandemic on cytology practice: An international survey in the Asia-Pacific region.

BACKGROUND: The purpose of the current study was to examine the impact of coronavirus disease 2019 (COVID-19) on various aspects of cytology practice in the Asia-Pacific region. METHODS: An online questionnaire was distributed to cytopathology laboratories in 24 Asia-Pacific countries to explore the impact of restrictive measures on access to health care, use of general and personal protective equipment (PPE), and changes in cytology workflow and workload from February to April 2020. RESULTS: A total of 167 cytopathology laboratories from 24 countries responded to the survey; the majority reported that restrictive measures that limited the accessibility of health care services had been implemented in their cities and/or countries (80.8%) and their hospitals (83.8%). The respondents noted that COVID-19 had an impact on the cytologic workflow as well as the workload. Approximately one-half of the participants reported the implementation of new biosafety protocols (54.5%) as well as improvements in laboratory facilities (47.3%). Rearrangement or redeployment of the workforce was reported in 53.3% and 34.1% of laboratories, respectively. The majority of the respondents reported a significant reduction (>10%) in caseload associated with both gynecological (82.0%) and nongynecological specimens (78.4%). Most laboratories reported no significant change in the malignancy rates of both gynecological (67.7%) and nongynecological specimens (58.7%) compared with the same period in 2019. CONCLUSIONS: The results of the survey demonstrated that the COVID-19 pandemic resulted in a significant reduction in the number of cytology specimens examined along with the need to implement new biosafety protocols. These findings underscore the need for the worldwide standardization of biosafety protocols and cytology practice.

Costs analysis of a training intervention for the reduction of preanalytical errors in primary care samples.

BACKGROUND: To perform a cost-error analysis based on a quasi-experimental pre-post study of the preanalytical errors in 2 hospital laboratories. The real cost and theoretical cost are defined as the cost resulting from errors with or without the training intervention. The real impact associated to the training program was estimated, calculated as the total associated to the preanalytical errors cost difference. The costs were measured using Andalusian Public Health Service fees. Cost analysis of an educational intervention presented in a previous study from 2017. Preanalytical errors were detected in the laboratories of the University Hospital Virgen de la Victoria (Málaga, Spain) and in the University Hospital Juan Ramón Jiménez (Huelva, Spain). METHODS: The founded errors were divided into blood and urine samples. Univariate sensitivity analysis was used to assess how parameter uncertainty impacted on overall results. Variations of parameters between 0% and 5% were substituted into the base case. RESULTS: The real impact associated with educational intervention in LAB1 was an increase of &OV0556;16,961.378, and the expected impact was an increase &OV0556;78,745.27 (difference of &OV0556;61,783.9). In LAB2, the real impact in the same period amounted to &OV0556;260,195.37, and the expected impact was &OV0556;193,905.83 (difference of -&OV0556;66,289.54). The results were different in the 2 laboratories, proving the intervention in only one of them to be more effective. CONCLUSIONS: Costs analysis determined that this training intervention can provide saves in the costs, as the effectiveness of the educational sessions in reducing preanalytical errors currently results in a significant decrease of the costs associated with these errors.

A Feasible Laboratory-Strengthening Intervention Yielding a Sustainable Clinical Bacteriology Sector to Support Antimicrobial Stewardship in a Large Referral Hospital in Ethiopia.

Background: Access to clinical bacteriology in low resource settings (LRS) is a key bottleneck preventing individual patient management of treatable severe infections, detection of antimicrobial resistance (AMR), and implementation of effective stewardship interventions. We sought to demonstrate the feasibility of a practical bundle of interventions aimed at implementing sustainable clinical bacteriology services at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia, and report on cost and intensity of supervision. Methods: Starting in Dec 2015, an intervention based on the CLSI QMS01-A guideline was established, consisting of (i) an initial needs assessment, (ii) development of key standard operating procedures, (iii) adaptation of processes for LRS, (iv) training and supervision of laboratory staff via consultant visits and existing online resources, and (v) implementation of a practical quality systems approach. A guiding principle of the bundle was sustainability of all interventions post implementation. Outcomes and challenges: An initial investment of ~US$ 26,200 for laboratory reagents, and a total of 50 visit-days per year from three Canadian and Norwegian microbiologists were committed. Twelve SOPs, including antimicrobial susceptibility testing, were adapted, and an automated blood culture platform was donated (bioMerieux). In the first 18 months of implementation of the intervention, the average volume of specimens analyzed in the lab went from 15/day to 75/day. The number of blood cultures tested increased from an average of 2/day to over 45/day. Antimicrobial susceptibility testing was introduced and cumulative antibiograms were generated for the institution. Quality control was implemented for all procedures and quality assurance tools implemented included external quality assurance and proficiency testing of six technologists with longitudinal follow-up. The laboratory is on the path toward SLIPTA accreditation by the African Society for Laboratory Medicine. Reagent costs, staff training and retention, and engagement of clinical personnel with the lab proved to be manageable challenges. Key external challenges include in-country supply-chain management issues, lack of competition among distributors, and foreign-currency exchange distortions. Conclusions: Using a relatively low-intensity intervention based on existing training tools and accreditation schemes, we demonstrate that establishment of reasonable-quality clinical bacteriology is not only within reach but also a critical step toward assessing the burden of AMR in settings like this one and implementing effective stewardship strategies.

Reference Laboratory Testing for Neurologic Disorders.

Laboratory testing plays a critical role in the diagnosis and monitoring of patients with neurologic disorders. Although common tests are often performed in a central hospital laboratory, an increasing number of essential but esoteric tests are performed at reference laboratories or other outside health care facilities. In this article, we analyze recent trends in neurologic disease testing within the overall context of reference laboratory testing and discuss strategies to facilitate the provision of high-quality, cost-effective laboratory services.

Role of cytotechnologists in rapid onsite adequacy assessment of cytology materials for diagnostic workup and specimen allocation for ancillary testing using a standardized protocol.

INTRODUCTION: Data on the performance of cytotechnologists in assessing specimen adequacy of needle core biopsies (NCB) is scant and their role in specimen triaging for ancillary studies have not been well established. MATERIALS AND METHODS: We retrospectively analyzed rapid onsite evaluation (ROSE) performed exclusively by cytotechnologists on 248 NCB and fine-needle aspiration (FNA) specimens. Overall adequacy and accuracy rates were determined by comparing to final diagnosis. We also reviewed the process of specimen allocation for ancillary testing to determine whether specimens were appropriately triaged at the time of ROSE. RESULTS: Of the 248 cases, 222 (89.5%) were touch imprint and 26 (10.5%) were FNA smears. The overall adequacy rate was 73.4% (182 of 248). Concordance for "adequate" interpretation by ROSE with unequivocal malignant or benign diagnoses on final interpretation was 95.6%. The sensitivity, specificity, and accuracy of ROSE for a final "positive for malignancy" were 89.2% (95% CI 83.04% to 93.69%), 43.24% (95% CI 31.77% to 55.28%), and 73.87% (95% CI 67.57% to 55.28%), respectively. Cases with "positive for malignancy" on final diagnosis were "adequate" by ROSE in 89.1% (132 of 148) and "inadequate" in 10.8% (16 of 148), P < 0.0001. Ancillary tests were performed in 168 of 248 (67.7%); the majority were immunohistochemical stains for determining tumor subtype. Predictive biomarkers were performed successfully in 100% of metastatic breast cancers. CONCLUSIONS: Cytotechnologists performed at a high level of competency in providing ROSE and allocating specimens for ancillary testing, which were performed successfully in the majority of cases. Implementation of a standardized protocol for tissue management/prioritization is of paramount importance to maximize tissue preservation and minimize wastage.

Assessment of the degree of adherence of medical laboratories to KDIGO 2012 guideline for evaluation and management of CKD in Czechia and Slovakia.

INTRODUCTION: The aim of the study is to assess the degree of adherence of medical laboratories to Kidney Disease Improving Global Outcomes (KDIGO) 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD) in laboratory practice in Czechia and Slovakia. MATERIALS AND METHODS: An electronic questionnaire on adherence to KDIGO 2012 guideline was designed by an external quality assessment (EQA) provider SEKK spol. s.r.o. The questionnaire was placed and distributed through website to all medical biochemistry laboratories in Czechia and Slovakia (N = 396). RESULTS: A total of 212 out of 396 laboratories responded to the questions, though some laboratories only answered some questions, those applicable to their practice. A total of 48 out of 212 laboratories adopted the KDIGO 2012 guideline in full extent. The metrological traceability of creatinine measurement to standard reference material of SRM 967 was declared by 180 out of 210 laboratories (two of the responding laboratories did not measure creatinine). Thirty laboratories are not well educated on traceability of creatinine measurement and seven laboratories do not calculate estimated glomerular filtration rate (eGFR). Both urinary albumin concentration and albumin to creatinine ratio are reported by 144 out of 175 laboratories (37 of the responding laboratories did not measure urinary albumin). CONCLUSION: Majority of laboratories in Czechia and Slovakia adopted some parts of the KDIGO 2012 guideline in their practice, but only 23% of the laboratories apply them completely. Thus, further education and action should be conducted to improve its implementation.

Decreasing daily blood work in hospitals: What works and what doesn't.

Recurrent, inappropriate laboratory testing is a costly and wasteful use of healthcare resources. Recognizing this problem, the American Board of Internal Medicine, Canadian Society of Internal Medicine, and the Canadian Association of Pathologist all supported the Choosing Wisely campaign to reduce laboratory investigations in patients who demonstrate clinical and laboratory stability. In this narrative, we review studies looking at a variety of approaches to reduce excessive testing including education, audit and feedback, computerized physician order entry system changes, and forcing functions. Each type of intervention has its own unique advantages and disadvantages, varying in complexity, disruptiveness, effectiveness, and sustainability. Before implementing any quality improvement project, it is important to analyze the local context to identify the root causes for the practice behavior and aim to use the minimal amount of intervention to achieve the desired result. Change is often incremental and will seldom occur with a single intervention or Plan-Do-Study-Act cycle. Garnering the support of opinion leaders and a quality improvement team will help make the process and intervention a success.

Inter-laboratory comparison of Ki-67 proliferating index detected by visual assessment and automated digital image analysis.

BACKGROUND: Proliferation rate is a major determinant of the biologic behavior of the tumor and provides information that can be used to guide treatment decisions. METHODS: This ring study included 27 pathologists from 14 Institutions, in order to assess inter-observer concordance between pathologists in Croatia. We analyzed Ki-67 proliferative index on ten randomly selected breast cancer samples comparing consistency between visual assessment using light microscopy compared to digital image analyses results from one central laboratory as a referral value. RESULTS: When we analyzed Ki-67 as numeric value high concordance rate was found between Ki-67 score visually assessed in all participating Institutions compared to referral value assessed by digital image analysis (ICC 0.76, 95% CI 0.58-0.91), and Krippendorff's alpha was 0.79 (95% CI 0.58-1.00). Concordance was better in slides with higher Ki-67 values. When we categorized Ki-67 values according to generally accepted 20% cut-off value we noticed the lower concordance rate among participants in our study. CONCLUSION: Proliferation remains one of the most important parameters for tumor characterization helpful in making clinical decisions, but it should be used with great caution. Standardization of the Ki-67 assessment is essential and proliferating index should be expressed as exact numeric value. For patients with proliferative index near the cut-off value, other factors must be considered in making clinical decisions.

What Factors Affect Patient Satisfaction in Public Sector Hospitals: Evidence from an Emerging Economy.

Patient satisfaction can identify specific areas of improvement in public sector hospitals. However, the Pakistani healthcare system, and quality of service delivery is rarely assessed through the perspective of patient satisfaction. Our study demonstrated the performance of public healthcare systems in Pakistan by interacting with physical services (tangible and environmental), doctor⁻patient communication, and pharmacy and laboratory services based on patient satisfaction. Primary data were collected from the patients by using a random sampling method. Patients who participated in the study were visitors of public hospitals' outpatient departments. A total of 554 questionnaires were circulated, and 445 were received. The confirmatory factor and multiple regression analyses were employed to analyze the collected data. The results revealed that laboratory, as well pharmacy services, had positive significant effects (p = 0.000) on patient satisfaction, while doctor⁻patient communication (p = 0.189) and physical facilities (p = 0.85) had an insignificant relationship with patient satisfaction. Therefore, it is suggested that a significant communication gap exists in the doctor⁻patient setting, and that Pakistan's healthcare system is deprived of physical facilities. Consequently, such services need further improvements.

Quality assessment of interpretative commenting and competency comparison of comment providers in China.

Background This study aimed to evaluate the ability of comment providers who were responsible for interpreting results in clinical laboratories in China and to improve the quality of interpretative comments. Methods Basic information and interpretative comments for five cases of 1912 routine chemistry External Quality Assessment (EQA) participant laboratories were collected by web-based EQA system in May 2018. EQA organizers assigned scores to each key phrase of comments based on predetermined marking scale and calculated total scores for each participant's answer. Final scores and ranking were calculated according to scores of cases. Finally, we comprehensively analyzed the type of hospital and the professional title of participants. Results In total, 772 clinical laboratories, 1472 participants, from different Chinese provinces submitted interpretative comments. Median scores, interquartile ranges and score ranges of the five cases were 13 (11-15, 1-20), 13 (10-16, 0-20), 15 (12-17, 0-21), 7 (5-9, -2 to 14) and 12 (10-13, -2 to 18). The final scores and ranking of participants that came from tertiary hospitals were higher than those from secondary and other hospitals; however, there were no significant differences (0.774). When grouped by professional title, we found that although no significant variability existed among senior, intermediate, junior and others (0.699), it existed between laboratory physicians and technicians, as the median final scores of the former were higher than the latter. Conclusions Practice and quality of interpretative comments are indeed different among different laboratories and participants in China. Laboratories should train and assess the interpretative ability of personnel. EQA organizers should also improve the scoring method and establish peer assessors team through this survey.

Reducing Diagnostic Errors Worldwide Through Diagnostic Management Teams.

A major challenge facing most countries is the growing cost of healthcare. Laboratory testing costs constitute approximately 3% of all clinical costs, while waste of funds due to inappropriate admissions to clinical departments is reported to be as high as 15%. A frequently used approach to save money in healthcare is random reduction of laboratory budgets, focusing on decreasing the number of unnecessary laboratory tests. The World Health Assembly has approached this problem by publishing a list of essential in vitro diagnostic tests, to achieve a global rationalization of the problem. A much more thoughtful strategy to reducing healthcare expenditure is to improve the efficiency of the diagnostic process. Decreasing the time to a correct diagnosis provides considerable financial and clinical benefits. Additionally, reducing both overutilization and underutilization of laboratory tests while achieving the correct diagnosis is of great benefit to challenged healthcare budgets. Examining the situation in the United States and Italy, this review presents an opportunity for reducing diagnostic error and increasing the efficiency of diagnostic testing worldwide. One approach taken to achieve major savings in healthcare in the United States, which can be applied in Italy and other countries, is the creation of "diagnostic management teams," comprising experts in specialty areas of medicine, primarily based in the clinical laboratory, who can advise physicians on the selection of necessary tests and the interpretation of complex test results.

Reducing Electrolyte Testing in Hospitalized Children by Using Quality Improvement Methods.

BACKGROUND AND OBJECTIVES: Despite studies indicating a high rate of overuse, electrolyte testing remains common in pediatric inpatient care. Frequently repeated electrolyte tests often return normal results and can lead to patient harm and increased cost. We aimed to reduce electrolyte testing within a hospital medicine service by >25% within 6 months. METHODS: We conducted an improvement project in which we targeted 6 hospital medicine teams at a large academic children's hospital system by using the Model for Improvement. Interventions included standardizing communication about the electrolyte testing plan and education about the costs and risks associated with overuse of electrolyte testing. Our primary outcome measure was the number of electrolyte tests per patient day. Secondary measures included testing charges and usage rates of specific high-charge panels. We tracked medical emergency team calls and readmission rates as balancing measures. RESULTS: The mean baseline rate of electrolyte testing was 2.0 laboratory draws per 10 patient days, and this rate decreased by 35% after 1 month of initial educational interventions to 1.3 electrolyte laboratory draws per 10 patient days. This change has been sustained for 9 months and could save an estimated $292 000 in patient-level charges over the course of a year. Use of our highest-charge electrolyte panel decreased from 67% to 22% of testing. No change in rates of medical emergency team calls or readmission were found. CONCLUSIONS: Our improvement intervention was associated with significant and rapid reduction in electrolyte testing and has not been associated with unintended adverse events.

Budget Impact of the Accreditation Program for Clinical Laboratories on Colorectal Cancer Screening via Fecal Immunochemical Testing: Results from the National Cancer Screening Program in Korea.

BACKGROUND: False-positive fecal immunochemical test (FIT) results in the National Cancer Screening Program (NCSP) for colorectal cancer may lead to unnecessary procedures, such as colonoscopies, increasing the medical costs. We estimated reductions in the cost of National Health Insurance according to the accreditation status of screening facilities participating in the NCSP for colorectal cancer. METHODS: We used data collected between 2007 and 2010 from NCSP and the Korea Central Cancer Registry to identify patients with colorectal cancer. We also ascertained the history of the accreditation of each facility by the Korean Laboratory Accreditation Program (KLAP). Budget impact was defined as a reduction in medical costs achieved when the false-positive rate of the non-accredited facilities decreased relative to that of the accredited facilities. RESULTS: A total of 3,285 screening facilities participated in the NCSP. Of these, 196 were accredited by the KLAP. The false-positive rate of the accredited facilities was 2.47%, and that of the non-accredited facilities was 6.83%. Medical costs were estimated to be reduced by approximately 19 million US dollars (USD), and the cost of detecting one case of colorectal cancer was estimated to decrease from 9,212 USD to 7,332 USD if the false-positive rate of non-accredited facilities were decreased to that of the accredited facilities. Clinics were estimated to have the largest associated cost reduction. CONCLUSIONS: Quality assurance in clinical laboratories could lower false-positive rates and prevent the use of unnecessary procedures, ensuring patient safety and increasing the cost-effectiveness of FIT screening in the NCSP for colorectal cancer.