CDC and Clinical Laboratory Partners: Analysis of Biosafety Gaps Revealed During the Ebola Outbreak

2019 ◽  
Vol 152 (Supplement_1) ◽  
pp. S139-S139
Author(s):  
Nancy Cornish ◽  
Sheldon Campbell ◽  
Elizabeth Weirich
Keyword(s):  
Patient Care ◽  
Health Care Providers ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
Future Research ◽  
Competency Assessment ◽  
Care Providers ◽  
Clinical Laboratories ◽  
Clinical Laboratory Testing

Abstract Objectives Patient care and public health in the United States depend on timely and reliable clinical laboratory testing. A third of the roughly 500 million yearly patient visits to health care providers involve at least one laboratory test, and approximately 70% of medical decisions are based upon test results. However, the performance of clinical laboratory testing could be compromised by patient specimens potentially contaminated with highly infectious materials. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola crisis, where fears about safety resulted in some institutions refusing or delaying tests on patient specimens, which resulted in delayed diagnoses and contributed to patient deaths. Methods In collaboration with subject matter experts from academia, medical centers, and federal institutions, the Centers for Disease Control and Prevention has reviewed the capability of clinical laboratories to safely test patient specimens potentially contaminated with highly infectious materials, like Ebola. Current biosafety guidance for clinical laboratories has been largely based on biosafety practices in research laboratories, so the guidelines do not always correspond to clinical laboratories and may be incomplete or occasionally inconsistent. While essential to patient care, clinical laboratories are also unique environments with specialized equipment, processes, and therefore distinct challenges. Here we discuss the complexity of clinical laboratories and describe how applying current biosafety guidance to clinical laboratories may be difficult and confusing at best or inappropriate and harmful at worst. We describe biosafety gaps and opportunities for improvement in the areas of ethics; risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; waste management; laboratory personnel training and competency assessment; and accreditation processes. Conclusion These identified gaps in knowledge and practice could inform future research and education in clinical laboratory biosafety.

scholarly journals Types of Assays for SARS-CoV-2 Testing: A Review

2020 ◽  
Vol 51 (5) ◽  
pp. e59-e65 ◽  
Author(s):  
Marie C Smithgall ◽  
Mitra Dowlatshahi ◽  
Steven L Spitalnik ◽  
Eldad A Hod ◽  
Alex J Rai
Keyword(s):  
Patient Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Direct Patient Care ◽  
Point Of Care Testing ◽  
Clinical Laboratories ◽  
Novel Coronavirus ◽  
Outpatient Settings ◽  
Clinical Laboratory Testing

Abstract Clinical laboratory testing routinely provides actionable results, which help direct patient care in the inpatient and outpatient settings. Since December 2019, a novel coronavirus (SARS-CoV-2) has been causing disease (COVID-19 [coronavirus disease 2019]) in patients, beginning in China and now extending worldwide. In this context of a novel viral pandemic, clinical laboratories have developed multiple novel assays for SARS-CoV-2 diagnosis and for managing patients afflicted with this illness. These include molecular and serologic-based tests, some with point-of-care testing capabilities. Herein, we present an overview of the types of testing available for managing patients with COVID-19, as well as for screening of potential plasma donors who have recovered from COVID-19.

National Inventory of Clinical Laboratory Testing Services (NICLTS)

2000 ◽  
Vol 124 (8) ◽  
pp. 1201-1208 ◽  
Author(s):  
Steven J. Steindel ◽  
William J. Rauch ◽  
Marianne K. Simon ◽  
James Handsfield
Keyword(s):  
Public Health ◽  
United States ◽  
Health Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
High Complexity ◽  
Specimen Type ◽  
The Us ◽  
Clinical Laboratory Testing

Abstract Context.—A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. Objective.—To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. Design.—Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. Main Outcome Measure.—Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. Results.—An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 ± 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions.—A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

Adherence to Choosing Wisely Campaign Guidelines at Three Health Systems

2021 ◽  
Vol 156 (Supplement_1) ◽  
pp. S119-S119
Author(s):  
A K Windham ◽  
M Whitted ◽  
B Brimhall ◽  
J Buckley ◽  
G Nichols ◽  
...  
Keyword(s):  
Health System ◽  
Health Systems ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Cost Savings ◽  
The United States ◽  
Choosing Wisely ◽  
Variable Cost ◽  
Clinical Laboratory Testing ◽  
Unnecessary Testing

Abstract Introduction/Objective With rising healthcare costs in the United States, there has been a push for lab stewardship to improve the quality of patient care while reducing costs. To optimize the use of clinical laboratory testing, the ASCP working with other medical specialty organizations, developed the Choosing Wisely Campaign to promulgate evidence-based guidelines to optimize clinical laboratory testing. Methods/Case Report We examined adherence to three Choosing Wisely guidelines over a four-year period (2017- 2020), through queries of internal cost accounting databases to return aggregate volumes as well as variable and total costs at three large academic health systems. We measured concurrent orders for: 1) erythrocyte sedimentation rate (ESR) with C-reactive protein (CRP), 2) serum/plasma amylase with lipase, and 3) free thyroxine (FT4) and/or total triiodothyronine (TT3) with thyroid stimulating hormone (TSH) when the TSH is within the reference range (using an frequency estimate of 85% based on other studies). We also examined another guideline for concurrent orders for serum aldolase with creatine kinase (CK). We also quantified aggregate variable costs for the non-recommended test in each Choosing Wisely guideline (amylase, ESR, FT4 and/or TT3), and for serum aldolase when ordered with CK. Results (if a Case Study enter NA) Over the four-year period, there were 322,853 unnecessary tests based on these four guidelines (120,587 ESR and CRP, 30,444 amylase and lipase, 164,818 FT4 and/or TT3 with TSH, and 7,004 aldolase). Overall, unnecessary testing decreased between 2017 and 2020 for amylase with lipase, remained essentially unchanged for aldolase, and increased for the other two test guideline scenarios. The largest changes were concurrent orders for amylase and lipase at one health system (38% decrease), and orders for TT3 with a normal TSH result at another health system (324% increase). The four-year variable cost of these unnecessary tests was $1,215,309 ($303,827 mean annual cost), resulting in potential annual variable cost savings of $101,276 for each health system for the four guidelines we examined. Variable costs for unnecessary testing increased by 16.5% ($45,571) over the four-year period. Conclusion Guideline-based unnecessary testing remains as a target to improve laboratory diagnostic testing. There is potential to realize significant achievable cost savings if guidelines are implemented and maintained.

Prospective risk analysis adjusted to the reality of clinical and fertility laboratory processes

Diagnosis ◽  
2015 ◽  
Vol 2 (4) ◽  
pp. 235-243 ◽  
Author(s):  
Pim M.W. Janssens ◽  
Anja Scholten ◽  
Harm De Waard ◽  
Natascha Tiemens ◽  
Monique Van Uum ◽  
...  
Keyword(s):  
Risk Analysis ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Practical Application ◽  
Laboratory Practice ◽  
Effect Analysis ◽  
Clinical Laboratories ◽  
Prospective Risk ◽  
Fmea Method ◽  
Clinical Laboratory Testing

AbstractProspective risk analysis (PRA) is a valuable instrument in quality assurance. The practical application of PRA in clinical laboratories according to the method we have described elsewhere leaves room for a number of adaptations to make it more applicable to and consistent with actual laboratory processes.We distinguished between more and less critical tests and products in the laboratory processes and scored the consequences of failures at different steps in line with the previously described failure type and effect analysis (FMEA) method. PRA was carried out for two typical laboratory processes: standard clinical laboratory testing and the cryopreservation of semen.Tests in standard clinical laboratory in processes were labeled critical, semi-critical or non-critical. Consequence scoring (C) and assessed risk (R) were significantly higher for processes containing tests considered to be critical (C=6.6±1.5, R=19.3±13.5) as compared to processes containing tests considered semi- or non-critical (C=3.0±1.4, R=8.2±5.3 and C=3.2±1.8, R=8.6±5.9, respectively). There were no differences in the C and R scores for processes with tests considered semi- or non-critical. In the semen cryopreservation process, a distinction between the processes involving private semen and generally accessible semen was made. The C scores for these were significantly different (C=5.9±2.2 and 5.0±2.0, respectively), the R scores did not differ.Introduction of a test criticality classification for the purpose of consequence scoring led to an improved PRA methodology, better reflecting the reality of clinical laboratory practice. We found that two levels of criticality, critical and less critical, were sufficient to achieve this improvement.

scholarly journals College Health Care Providers’ Student-Centered Care

2016 ◽  
Author(s):  
Cheryl Ann Lambert ◽  
Julie Donovan
Keyword(s):  
Health Care ◽  
Patient Care ◽  
Health Care Providers ◽  
The United States ◽  
Reputation Management ◽  
College Health ◽  
Care Providers ◽  
Student Centered ◽  
Centered Care ◽  
The University

Patient care in the university setting is indelibly connected to college health care providers. College health care providers adapt to a specific set of circumstances unique to the university context in their patient care roles. The authors therefore sought to investigate the patient care phenomenon from college health care providers’ lived experiences. The patient care phenomenon was explored via in-depth interviews with 11 college health care providers at universities in the Midwest and Northeast regions of the United States. The phenomenological theoretical framework of the study revealed five themes of patient care during data analysis: health education, behavioral health, student advocacy, relationship management, and reputation management. The authors designate the multi-dimensional nature of the patient care phenomenon “student-centered care” and consider practical implications for other providers who treat young university-age patients.

scholarly journals Consensus Statement: Feature and Function Recommendations to Optimize Clinician Usability of Direct Interoperability to Enhance Patient Care

2018 ◽  
Vol 09 (01) ◽  
pp. 205-220 ◽  
Author(s):  
Steven Lane ◽  
Holly Miller ◽  
Elizabeth Ames ◽  
Lawrence Garber ◽  
David Kibbe ◽  
...  
Keyword(s):  
Patient Care ◽  
Health Care Providers ◽  
Data Exchange ◽  
Consensus Statement ◽  
Clinical Care ◽  
The United States ◽  
Care Providers ◽  
Consensus Recommendation ◽  
Policy Makers ◽  
And Function

Background Secure clinical messaging and document exchange utilizing the Direct Protocol (Direct interoperability) has been widely implemented in health information technology (HIT) applications including electronic health records (EHRs) and by health care providers and organizations in the United States. While Direct interoperability has allowed clinicians and institutions to satisfy regulatory requirements and has facilitated communication and electronic data exchange as patients transition across care environments, feature and function enhancements to HIT implementations of the Direct Protocol are required to optimize the use of this technology. Objective To describe and address this gap, we developed a prioritized list of recommended features and functions desired by clinicians to utilize Direct interoperability for improved quality, safety, and efficiency of patient care. This consensus statement is intended to inform policy makers and HIT vendors to encourage further development and implementation of system capabilities to improve clinical care. Methods An ad hoc group of interested clinicians came together under the auspices of DirectTrust to address challenges of usability and create a consensus recommendation. This group drafted a list of desired features and functions that was published online. Comments were solicited from interested parties including clinicians, EHR and other HIT vendors, and trade organizations. Resultant comments were collected, reviewed by the authors, and incorporated into the final recommendations. Results This consensus statement contains a list of 57 clinically desirable features and functions categorized and prioritized for support by policy makers, development by HIT vendors, and implementation and use by clinicians. Conclusion Fully featured, standardized implementation of Direct interoperability will allow clinicians to utilize Direct messaging more effectively as a component of HIT and EHR interoperability to improve care transitions and coordination.

scholarly journals Pedagogy That Makes a Difference: A Netnographic Analysis (Preprint)

2021 ◽  
Author(s):  
Jennie C. De Gagne ◽  
Paula D. Koppel ◽  
Hyeyoung K. Park ◽  
Allen Cadavero ◽  
Eunji Cho ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Freedom Of Expression ◽  
Learning Experiences ◽  
Real Life ◽  
Health Professions ◽  
The United States ◽  
Future Research ◽  
World Knowledge ◽  
Care Providers ◽  
Effective Pedagogy

BACKGROUND Effective pedagogy that encourages high standards of excellence and commitment to lifelong learning is essential in health professions education to prepare students for real-life challenges such as health disparities and global health issues. Creative learning and innovative teaching strategies empower students with high quality, practical, real-world knowledge and meaningful skills to reach their potential as future health care providers. OBJECTIVE The aim of this study was to explore health professions students’perceptions of whether their learning experiences were associated with good or bad pedagogy during asynchronous discussion forums. The further objective of the study was to identify how perceptions of best and worst pedagogical practices reflected the students’ values, beliefs, and understanding about factors that made a pedagogy good during their learning history. METHODS A netnographic qualitative design was employed in this study. The data were collected on February 3, 2020 by exporting archived data from multiple sessions of a graduate-level nursing course offered between the Fall 2016 and Spring 2020 semesters at a large private university in the southeast region of the United States. Each student was a data unit. As an immersive data operation, field notes were taken by all research members. Data management and analysis were performed with NVivo 12. RESULTS A total of 634 posts were generated by 153 students identified in the dataset. Most of these students were female (88.89%). From the 97 categories identified, four themes emerged: (T) teacher presence built through relationship and communication, (E) environment conducive to affective and cognitive learning, (A) assessment and feedback processes that yield a growth mindset, and (M) mobilization of pedagogy through learner- and community-centeredness. CONCLUSIONS The themes that emerged from our analysis confirm findings from previous studies and provide new insights. Our study highlights the value of technology as a tool for effective pedagogy. The resourceful teacher can use various communication techniques to develop meaningful connections between learner and teacher. Styles of communication will vary according to the unique expectations and needs of learners with different learning preferences; however, the aim is to fully engage each learner, establish a rapport between and among students, and nurture an environment characterized by freedom of expression in which ideas flow freely. We suggest that future research continue to explore the influence of differing course formats and pedagogical modalities on student learning experiences. CLINICALTRIAL N/A

scholarly journals The Doctorate in Clinical Laboratory Sciences: A New Curriculum to Enhance the Connection of the Laboratory to Health Care Providers

2021 ◽  
Vol 8 ◽  
pp. 237428952110341
Author(s):  
Jose H. Salazar ◽  
Christopher J. Zahner ◽  
Vicki S. Freeman ◽  
Michael Laposata
Keyword(s):  
Health Care ◽  
Patient Care ◽  
Health Care Providers ◽  
Clinical Laboratory ◽  
Diagnostic Errors ◽  
Management Team ◽  
Advanced Practice ◽  
Care Providers ◽  
Diagnostic Management ◽  
Clinical Laboratory Sciences

This report discusses the need for a Doctorate in Clinical Laboratory Sciences program and describes a curriculum to train Doctorate in Clinical Laboratory Sciences students. The Doctorate in Clinical Laboratory Sciences program was developed to help reduce diagnostic errors in patient care by enhancing connections between the clinical laboratory and health care providers. Data are presented from program implementation in 2016 to 2017 academic year to 2019 to 2020 regarding the faculty and student demographics, program statistics (eg, admissions and attrition rates), and effectiveness. Perceptions of program effectiveness were obtained via surveys from 28 faculty physicians who supervised Doctorate in Clinical Laboratory Sciences students during clinical service rotations. Another survey assessed the preferred type of practice after graduation of 33 students. Over the 4-year period, the program had a 50% rate of admission and a 21.8% attrition rate. As of December 2020, 15 students graduated from the program. The majority (69%-82%) of physician faculty who completed the survey agreed that Doctorate in Clinical Laboratory Sciences students contributed positively at clinical rounds. Approximately two-thirds of students reported a preference to lead a Diagnostic Management Team or serve as an advanced practice provider in a Diagnostic Management Team with leadership provided by an MD/DO or PhD. This report provides useful information for other institutions that may want to establish similar Doctorate in Clinical Laboratory Sciences programs. Early data suggest that our program effectively trains doctoral-level advanced practice medical laboratory scientists, who may play an important role in improving patient safety by reducing diagnostic errors and providing value-based, optimal patient care.

Palliative Care for the Asian American Adult Population: A Scoping Review

2020 ◽  
pp. 104990912092806
Author(s):  
In Seo La ◽  
Mei Ching Lee ◽  
Katherine A. Hinderer ◽  
Iris Chi ◽  
Ruotong Liu ◽  
...  
Keyword(s):  
United States ◽  
Palliative Care ◽  
Health Care Providers ◽  
Asian American ◽  
Scoping Review ◽  
Adult Population ◽  
The United States ◽  
Future Research ◽  
Care Providers ◽  
Scoping Reviews

Background: The Asian American (AA) population is rapidly becoming one of the largest racial/ethnic groups in the United States. Despite this growth and advances in palliative care (PC) programs in the United States, the scope and nature of the literature regarding PC for AAs remains unclear. This review provides an overview of existing research on PC for AAs, identifies gaps in the research with recommendations for future research and delineates practice implications. Methods: A scoping review of studies published in English was conducted. Electronic Databases (PubMed, Embase, CINAHL, and PsycINFO databases) were searched up to December 2019. No starting date limit was set. Arksey and O’Malley’s methodological framework was followed for scoping reviews. Results: Of 2390 publications initially identified, 42 studies met our inclusion criteria for this review. Southeast AA subgroups remain understudied compared to East and South AAs. Most studies were descriptive; a few (n = 3) evaluated effectiveness of PC interventions for AAs. Research synthesized in this review addresses the following topics and includes considerations in PC related to care recipients and their relatives: treatment choice discussions (73%), coordination of care with health care providers (26%), symptom management (14%), and emotional support (10%). This review identified various factors around PC for AAs, specifically the influence of cultural aspects, including levels of acculturation, traditional norms and values, and religious beliefs. Conclusion: A culturally inclusive approach is vital to providing appropriate and accessible PC for AAs. Further research is needed concerning core PC components and effective interventions across diverse AA subgroups.

scholarly journals Stakeholder-Guided Formation of a Statewide Community Pharmacy Practice-Based Research Network

Pharmacy ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 118
Author(s):  
Joni C. Carroll ◽  
Melissa Somma McGivney ◽  
Kim C. Coley
Keyword(s):  
Community Pharmacy ◽  
Patient Care ◽  
Health Care Providers ◽  
Patient Engagement ◽  
Pharmacy Practice ◽  
Research Participation ◽  
The United States ◽  
Research Network ◽  
Care Providers ◽  
Practice Based Research

Community pharmacies across the United States are forming clinically integrated networks (CINs) to facilitate the provision of patient-centered care. These networks need to continually innovate and demonstrate how their patient care services positively impact health outcomes. One way to do this is to develop a practice-based research network (PBRN) in partnership with existing CINs to perform robust outcome evaluations. The objective of this study was to learn pharmacists’ opinions on participating in research to facilitate the formation of a community pharmacy PBRN in Pennsylvania. A 20-item survey gathered information on pharmacists’ research interests, perceived benefits of research participation, and preferences on communication and patient engagement. Descriptive statistics and Chi-square tests were used to analyze quantitative data. Seventy-three participants completed the survey, with 47% representing independent pharmacies. The majority (96%) were interested in research opportunities and 86% believed improving workflow and patient care was the most valuable benefit. Eighty percent of pharmacists reported it is very important to demonstrate that pharmacists care about making patients’ health better. Connecting pharmacists with other health care providers was reported as very important by 75% of respondents. Pharmacists reported face-to-face communication (76%) as their preferred way to approach patients about research and 72% supported using student pharmacists to assist with patient engagement. The results from this study can inform others who are structuring processes and developing communication strategies for community pharmacy PBRNs, particularly in partnership with CINs.

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