Changes in Test Volumes During Coronavirus Disease 2019 (COVID-19): A Laboratory Stewardship Opportunity.

CONTEXT.­: Coronavirus disease 2019 (COVID-19) changed the dynamics of health care delivery, shifting patient priorities and deferring care perceived as less urgent. Delayed or eliminated care may place patients at risk for adverse outcomes. OBJECTIVE.­: To identify opportunities for laboratory test stewardship to close potential gaps in care created by the COVID-19 pandemic. DESIGN.­: The study was a retrospective time series design examining laboratory services received before and during the COVID-19 pandemic at a large metropolitan health system serving women and children. RESULTS.­: Laboratory test volumes displayed 3 distinct patterns: (1) a decrease during state lockdown, followed by near-complete or complete recovery; (2) no change; and (3) a persistent decrease. Tests that diagnose or monitor chronic illness recovered only partially. For example, hemoglobin A1c initially declined 80% (from 2232 for April 2019 to 452 for April 2020), and there was a sustained 16% drop (28-day daily average 117 at August 30, 2019, to 98 at August 30, 2020) 4 months later. Blood lead dropped 39% (from 2158 for April 2019 to 1314 for April 2020) and remained 23% lower after 4 months. CONCLUSIONS.­: The pandemic has taken a toll on patients, practitioners, and health systems. Laboratory professionals have access to data that can provide insight into clinical practice and identify pandemic-related gaps in care. During the pandemic, the biggest patient threat is underuse, particularly among tests to manage chronic diseases and for traditionally underserved communities and people of color. A laboratory stewardship program, focused on peri-pandemic care, positions pathologists and other laboratory professionals as health care leaders with a commitment to appropriate, equitable, and efficient care.

A Snapshot of Lipid-Reporting Practices in Canadian Clinical Laboratories: An Urgent Need for Harmonisation.

To effectively implement the Canadian Cardiovascular Society (CCS) guidelines for dyslipidemia management into clinical laboratories, clear recommendations for lipid reporting are essential. In this study, the Canadian Society of Clinical Chemists Working Group on Reference Interval Harmonisation surveyed Canadian laboratories on adult lipid reporting practices to set a foundation for the development and implementation of harmonised lipid reporting across Canada. Key aspects of the survey asked laboratories: what reporting parameters were in place to assess lipid results; what interpretative comments were provided; whether nonfasting lipids were permitted and, if so, what strategy was used to document fasting status; and whether there was interest in implementing a harmonised lipid report. A total of 101 laboratories were represented by 24 respondents, as many responses were submitted by laboratory networks that included more than 1 laboratory. There was at least 1 response from 9 Canadian provinces and representation across 5 testing platforms. Upper and lower limits for lipid parameters and referenced source of limits varied substantially across laboratories, with only 56% of laboratories (9 respondents) referencing the 2016 CCS guidelines. Eighty-six percent of laboratories (19 respondents) report nonfasting lipids, although the method of documenting nonfasting status varied. Overall, 36% of laboratories (8 respondents) reported interest in implementing a harmonised lipid report. Assessment of current lipid-reporting practices supports the need for harmonised lipid reporting across Canada. Development of a harmonised lipid report for the adult population, consistent with up-to-date Canadian guidelines, will improve continuity of lipid test interpretation across Canada and improve clinical decision making.

COVID-19 Pandemic Planning: Simulation Models to Predict Biochemistry Test Capacity for Patient Surges.

BACKGROUND: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients. METHODS: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload. RESULTS: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site. CONCLUSIONS: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic.

Laboratorio de diagnóstico clínico y/o de vigilancia epidemiológica: norma técnica No. 22-2019-DRACES / Laboratory for clinical diagnosis and / or epidemiological surveillance: technical standard No. 22-2019-DRACES

La tinta del documento está bastante opaca. DRACES [Departamento de Regulación, Acreditación y Control de Establecimientos de Salud] Este documento tiene como objeto: "la regulación, autorización y control de los laboratorios de diagnóstico clínico y/o de vigilancia epidemiológica, en concordancia con el Reglamento para la Regulación, Autorización, Acreditación y Control de Establecimientos de Atención para la Salud, Acuerdo Gubernativo 376-2007." Es de carácter obligatorio, por lo que se aplica tanto al sector público, privado, social o subsector de la seguridad social, en todo el territorio nacional. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada clínica, incluidos el equipo y recurso humano y técnico. En el capítulo II, incluye una clasificación del nivel de laboratorios, describiendo sus características, servicios, horarios, materiales técnicos y equipos.

Aplicación de Seis Sigma en el Laboratorio Clínico / Six Sigma Application in the Clinical Laboratory

Seis Sigma es un método de mejora de procesos que se focaliza en disminuir la variabilidad de los mismos. El enfoque más común es contar los defectos, determinar el porcentaje, convertirlos a una tasa de defectos por millón y luego usar una tabla para buscar la métrica sigma apropiada. El segundo enfoque consiste en utilizar la medida de la variación del proceso para estimar la métrica sigma. En el laboratorio clínico se pueden aplicar ambos conceptos según la etapa del laboratorio en la cual se pretenda usar la métrica sigma. Para ambos enfoques un proceso de 6 sigmas es considerado un proceso eficiente, de alta calidad. En este trabajo se planteó para la etapa preanalítica una meta mínima de 4 sigmas. Algunos procesos muestran un buen desempeño con indicadores de calidad con sigmas mayores de 4. Sin embargo, varios de ellos tienen sigmas menores que la meta propuesta demostrando ser los más vulnerables. En Química Clínica y Hematología, la elección del requisito de calidad es el punto clave para armonizar la métrica sigma junto a la estrategia para la obtención del error sistemático y aleatorio. En este trabajo se muestran las diferentes estrategias para relacionar el desempeño basado en el sigma del proceso analítico con las reglas de validación de las corridas analíticas.

Six Sigma is a method for improvement of processes that focuses on reducing their variability. The most common approach is to count the defects, determine the percentage, convert them to a defect rate per million and then use a table to find the appropriate sigma metric. The second approach consists of using the process variation measure to estimate the sigma metric. In the clinical laboratory, both concepts can be applied according to the stage of the laboratory in which the sigma metric is intended to be used. For both approaches, a 6 sigma process is considered an efficient, high quality process. In this work, a minimum goal of 4 sigma was raised for the preanalytical stage. Some processes show good performance with quality indicators with sigma greater than 4. However, several of them have sigma lower than the proposed goal proving to be the most vulnerable. In Clinical Chemistry and Hematology, the choice of the quality requirement is the key point to harmonize the Sigma metric together with the strategy to obtain systematic and random error. This paper shows the different strategies to relate the performance based on the sigma of the analytical process with the validation rules of the analytical runs.

Seis Sigma é um método de melhoria de processos focado na redução da sua variabilidade. A abordagem mais comum é contar os defeitos, determinar a porcentagem, convertê-los numa taxa de defeitos por milhão e, depois disso, usar uma tabela para procurar a métrica sigma apropriada. A segunda abordagem consiste em usar a medida da variação do processo para estimar a métrica sigma. No laboratório clínico, podem ser aplicados os dois conceitos de acordo com a fase do laboratório em que se pretenda usar a métrica sigma. Para ambas as abordagens, um processo de 6-sigmas é considerado um processo eficiente e de alta qualidade. Neste trabalho, uma meta mínima de 4 sigmas foi definida para o estágio pré-analítico. Alguns processos mostram bom desempenho com indicadores de qualidade com sigmas maiores que 4. No entanto, vários deles têm sigmas menores que a meta proposta provando ser os mais vulneráveis. Em Química Clínica e Hematologia, a escolha do requisito de qualidade é o ponto chave para harmonizar a métrica sigma juntamente com a estratégia para obter o erro sistemático e aleatório. Este artigo mostra as diferentes estratégias para relacionar o desempenho baseado no sigma do processo analítico com as regras de validação das execuções analíticas.

Experience of Indian association of medical microbiology external quality assurance scheme centre, New Delhi: Challenges and quality assessment of clinical microbiology laboratories.

Introduction: EQAS program at New Delhi under IAMM was started in January 2014 across North and North east regions of India with 217 participants, which grew up to 540 by 2018. Materials and Methods: In 2014, 4 analytes per year were sent for 3 exercises, i.e. smear culture and serology. 2018 onwards PT analytes were increased from 4 to 12 and comparative performance of techniques analysed. Results: Out of the 22 smears sent for gram staining, ZN staining, Kinyoun staining and Albert staining, completely correct results ranged between 29.55% - 79.9%, 94.3% - 99.2%, 35.5% & 93.8%, respectively. Correct results for culture isolate identification & susceptibility testing and serology exercises varied between 70 & 92.4% and 73.1 & 98.59%, respectively. In the year 2018, 470 responses were received for bacterial culture identification & antibiotic susceptibility testing out of which manual and automated systems were used by 54% & 46% and 52.5% & 47.5% participants, respectively. Techniques used in BBV assays for HBsAg, HCV & HIV found all methods like ELISA, ELFA, CLIA and Card Test performing similarly. The major challenges in running the EQA program included requirement of large amount of specimens for PT item preparation, stability in hot and humid conditions and timely delivery of PT challenges in remote parts of the country. Conclusion: A large number of the participating laboratories (77%) had an overall score of >80% for all exercises, demonstrating acceptable baseline performance of EQAS registered laboratories. However, continued EQAS participation could further improve the quality of results.

Advances in Rapid Molecular Blood Culture Diagnostics: Healthcare Impact, Laboratory Implications, and Multiplex Technologies.

BACKGROUND: For far too long, the diagnosis of bloodstream infections has relied on time-consuming blood cultures coupled with traditional organism identification and susceptibility testing. Technologies to define the culprit in bloodstream infections have gained sophistication in recent years, notably by application of molecular methods. CONTENT: In this review, we summarize the tests available to clinical laboratories for molecular rapid identification and resistance marker detection in blood culture bottles that have flagged positive. We explore the cost-benefit ratio of such assays, covering aspects that include performance characteristics, effect on patient care, and relevance to antibiotic stewardship initiatives. SUMMARY: Rapid blood culture diagnostics represent an advance in the care of patients with bloodstream infections, particularly those infected with resistant organisms. These diagnostics are relatively easy to implement and appear to have a positive cost-benefit balance, particularly when fully incorporated into a hospital's antimicrobial stewardship program.

Rapid Diagnostics for Blood Cultures: Supporting Decisions for Antimicrobial Therapy and Value-Based Care.

Bacteremia and sepsis are critically important syndromes with high mortality, morbidity, and associated costs. Bloodstream infections and sepsis are among the top causes of mortality in the US, with >600 deaths each day. Most septic patients can be found in emergency medicine departments or critical care units, settings in which rapid administration of targeted antibiotic therapy can reduce mortality. Unfortunately, routine blood cultures are not rapid enough to aid in the decision of therapeutic intervention at the onset of bacteremia. As a result, empiric, broad-spectrum treatment is common-a costly approach that may fail to target the correct microbe effectively, may inadvertently harm patients via antimicrobial toxicity, and may contribute to the evolution of drug-resistant microbes. To overcome these challenges, laboratorians must understand the complexity of diagnosing and treating septic patients, focus on creating algorithms that rapidly support decisions for targeted antibiotic therapy, and synergize with existing emergency department and critical care clinical practices put forth in the Surviving Sepsis Guidelines.

[Patient-initiated diagnostics - a challenge for laboratory medicine]. / Egenordinerad provtagning kan ge laboratoriemedicinen ny roll.

Citizens can now order their own laboratory investigations. Self-testing is in line with increasing patient empowerment and in conflict with existing routines in medicine where all tests are ordered by the physician. Several challenges have to be faced by laboratory medicine to secure the quality and increase the medical benefits of patient-initiated diagnostics.

Clinical laboratory: bigger is not always better.

Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.

Horizon Scan Of Clinical Laboratories Offering Pharmacogenetic Testing.

Pharmacogenetic (PGx) testing involves the analysis of genes known to affect response to medications. The field has been projected as a leading application of personalized or precision medicine, but the use of PGx tests has been stymied, in part, by the lack of clinical evidence of utility and reported low provider awareness. Another factor is the availability of testing. The range and types of PGx tests available have not been assessed to date. In the period September 2017-January 2018 we analyzed the numbers and types of PGx tests offered by clinical testing laboratories in the US. Of the 111 such labs that we identified, we confirmed that 76 offered PGx testing services. Of these, 31 offered only tests for single genes; 30 offered only tests for multiple genes; and 15 offered both types of tests. Collectively, 45 laboratories offered 114 multigene panel tests covering 295 genes. The majority of these tests did not have any clinical guidelines. PGx tests vary in type and makeup, which presents challenges in appropriate test evaluation and selection for providers, insurers, health systems, and patients alike.

Probabilistic Modeling Approach to Reducing Healthcare Costs With Reflex Testing.

OBJECTIVE: Statistical methods can be utilized to optimize the order for reflex diagnostic testing to attenuate patient and hospital costs without affecting quality of care. Our objective is to demonstrate the method of developing an order for testing and to apply this method to an illustrative example. METHODS: An algorithm was developed for minimizing costs for any given number of diagnostic tests, and it was retrospectively applied to a sample. RESULTS: The actual scenario of using both tests on all patients was compared to 2 other hypothetical reflex testing approaches: all patients are given 1 test, and those patients who tested negative were then given the second test. The 2 scenarios would have saved 37.1% and 17.4% in testing costs, respectively. CONCLUSION: These calculations could be applied to numerous situations to reduce costs for patients and hospitals. We propose that this methodology would be best used in conjunction with any existing quality improvement initiatives.

Modelo de gestión impuesto por la transformación tecnológica en los laboratorios de análisis clínicos. Impacto en el Hospital Garrahan a treinta años de historia / Management model imposed by the technological transformation in clinical analysis laboratories. Impact at Hospital Garrahan on thirty years of history

Las actividades del laboratorio de análisis clínicos están fuertemente identificadas con el ritmo del cambio tecnológico. En los últimos treinta años se vive un cambio de época que afecta la cultura y la experiencia humana en todos sus aspectos. Este cambio modifico el modelo de producción. En el laboratorio ha incorporado tecnología que combina la química, la robótica, la óptica y la informática, y se ha impuesto como premisa externa de cambio un modelo de gestión global que afecta la forma de trabajo, la gestión y el rol de los profesionales (bioquímicos y técnicos). El hospital Garrahan inscribe su historia dentro de este periodo histórico y el proceso de cambio ha generado y genera incertidumbre, resistencia y adecuaciones al nuevo paradigma impuesto. Nos fijamos como objetivo analizar el impacto de este cambio sobre la gestión de procesos del laboratorio de nuestro hospital. Comprobamos que la demanda del laboratorio se incrementó al ritmo del crecimiento de consultas y egresos de pacientes, y de como este aumento demando adecuaciones de gestión, modificaciones arquitectónicas, incorporación de tecnologías (algunas emergentes), aumento en la trazabilidad de muestras y resultados, y mejoras en la seguridad del paciente en todos sus aspectos. Describimos el nuevo paradigma, sus ventajas, las adecuaciones hechas y los tiempos en que se fueron realizados. Concluimos sugiriendo un rol para los profesionales del laboratorio en función del paradigma en curso

Activities at the laboratory of clinical analysis are closely related to the pace of technological change. Over the past 30 years there has been a change of times affecting human culture and experience in all its aspects. This change has modified the model of production. The laboratory has incorporated technology combining chemistry, robotics, and optics, as well as information technology, and the premise of a global management model has been imposed affecting the way of working, administration, and the role of professionals (biochemists and technicians). Garrahan hospital has written its own history in this historical period and process of change has produced uncertainty, resistance as well as adaptation to this new paradigm. Our aim has been to analyze the impact of this change on the management of processes of the laboratory of our hospital. We have observed that the demand of the laboratory has increased at the same pace as the increase of patient visits and discharges. This increase has required modifications in the management and facilities, incorporation of new technologies (some of them state of the art), improved traceability of the samples and results, and improvements in patient safety in all aspects. Here we describe the new paradigm, its advantages, adaptations made, and improved times introduced. In our conclusions, we consider the new role for laboratory professionals in this paradigm.

AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance: an evolutionary outsourcing model.

The AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance (CBioA) was launched in 2011 after a period of global economic recession. In this challenging environment, AstraZeneca elected to move to a full and centralized outsourcing model that could optimize the number of people supporting bioanalytical work and reduce the analytical cost. This paper describes the key aspects of CBioA, the innovative operational model implemented, and our ways of ensuring this was much more than simply a cost reduction exercise. As we have recently passed the first 5-year cycle, this paper also summarizes some of the concluding benefits, wins and lessons learned, and how we now plan to extend and develop the relationship even further moving into a new clinical laboratory partnership.

Clinical pathologists and physician in France: which partnership and which future?

Medical biology is a major area of medical specialization in French health care system. It is going through massive changes in public as in private sector since the 2010 Ballereau edict with the merging of laboratories and new quality standards based on accreditation. We have suggested that physicians had a negative feeling about the restructuring of medical biology in recent years. An electronic questionnaire has been sent to physicians so as to find out what they thought about the evolution of medical biology and to get suggestions to improve the taking care of the patient. Have answered 1364 residents and physicians from all specializations, all regions, practicing in public or private hospitals or in general practices. Doctors have on the whole a negative feeling about how medical biology has evolved in recent years thinking that it is moving towards industrialization with delay increasing. They are convinced that tests must be made on site. They remain satisfied with the quality of the tests and have a positive feeling about scientific evolutions and are in favor of a better clinical-biological cooperation. The study points out a lack of clarity concerning how private laboratories are organized and how they operate. A computer link between clinical pathologists and physicians to access results and a list of urgent medical examinations could be set up so as to have a more rapid access to results. Rapid diagnostic tests or delocalized biology could be used but doctors do not want these tests to replace the clinical pathologist.

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).

It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting "Improving quality in the preanalytical phase through innovation" in Amsterdam, 24-25 March, 2017.

"This thing of testing our blood is really very important": a qualitative study of primary care laboratory services in Tete Province, Mozambique.

BACKGROUND: Laboratory services are essential for diagnosis and management of patients, and for disease control, and should form an integral part of primary health services capable of contributing to Universal Health Coverage. Nevertheless, they remain among the most neglected health services in resource-poor countries, including Mozambique. The Health Directorate of Tete Province, Mozambique, developed this study to analyse the role and perceived impact of laboratory services in primary healthcare on access, perceived service quality and disease control. METHODS: Qualitative research was done in three primary health facilities with and three without a laboratory in Tete Province, purposively sampled for their available services, accessibility and size. The role of the laboratory in primary health care was explored by reviewing documents, including records and monthly reports, interviews with clinicians, laboratory technicians and key informants (community leaders), and through focus group discussions with beneficiaries. Numeric data were summarized in Microsoft™ Excel. Qualitative data were analysed for content within generated categories, interpreted within the concept of Universal Health Coverage, cross validated between the researchers. RESULTS: The results showed a greater use of health services, with more frequent diagnosis and monitoring of prevalent diseases, in facilities with a laboratory as compared with facilities without. Clinicians, patients and community leaders in facilities with a laboratory perceived an improved possibility of diagnosing and treating prevalent diseases, resulting in greater satisfaction with the provided services. Laboratory technicians confirmed that patients appreciated having access to laboratory tests. Clinicians, patients and community leaders in facilities without a laboratory protested its lack, claiming that it increased the likelihood of costly referrals, delays and even deaths. CONCLUSIONS: The study concluded that the laboratory plays an important role in primary level health facilities, as it is associated with greater utilization and perceived higher quality of services. Lack of a laboratory hampers patient management, disease control and financial risk protection. Expansion of the clinical laboratory system at primary level health facilities should be a properly funded priority of the national health system in Mozambique and similar countries.