Bill would bar NIH and CDC from funding lab research in China.

House of Representatives measure catalyzed in part by suspicions that Wuhan lab leak led to pandemic.

Sustainable Laboratory-Driven Method to Decrease Repeat, Same-Day WBC Differentials at a Tertiary Care Center.

OBJECTIVES: A CBC with WBC differential is often ordered when a CBC alone would be sufficient for patient care. Performing unnecessary WBC differentials adds to costs in the laboratory. Our objective was to implement a laboratory middleware algorithm to cancel repeat, same-day WBC differentials to achieve lasting improvements in laboratory resource allocation. METHODS: Repeat same-day WBC differentials were first canceled only on intensive care unit samples; after a successful trial period, the algorithm was applied hospital-wide. We retrospectively reviewed CBC with differential orders from pre- and postimplementation periods to estimate the reduction in WBC differentials and potential cost savings. RESULTS: The algorithm led to a monthly WBC differential cancellation rate of 5.40% for a total of 10,195 canceled WBC differentials during the cumulative postimplementation period (September 25, 2019, to December 31, 2020). Nearly all (99.94%) differentials remained canceled. Most patients only had one WBC differential canceled (range, 1-38). Savings estimates showed savings of $0.99 CAD per canceled differential and 1,060 minutes (17.7 hours) of technologist time. CONCLUSIONS: A middleware algorithm to cancel repeat, same-day WBC differentials is a simple and sustainable way to achieve lasting improvements in laboratory utilization.

What if we just give everything away?

A group leader decided that his lab would share the fluorescent dyes they create, for free and without authorship requirements. Nearly 12,000 aliquots later, he reveals what has happened since.

How the US Sanctions Are Affecting the Health Research System in Iran?

BACKGROUND: In November 2018, the United States withdrew from the Joint Comprehensive Plan of Action (JCPOA), known commonly as the Iran nuclear deal, and imposed severe sanctions on Iran. This study explores the impact of US sanctions in Iran's health research system. METHODS: This phenomenological study interviewed 24 Iranian health science scholars through purposeful sampling to learn about their experiences and thoughts regarding the impact of US sanctions on Iran's health research system. RESULTS: The impact of sanctions on Iran's health research system were classified into five categories: (a) financial issues, (b) difficulty in supplying laboratory materials and (c) equipment, (d) disruption in international research collaboration and activities, and (e) other issues (e.g., increased stress and workload). CONCLUSION: This study indicated that since research centers in Iran are highly dependent on governmental budgets, sanctions have greatly affected the health research system in Iran. Financial and economic problems, restrictions in transferring funds, and the disruption in political and international relations have created many challenges for supplying medical laboratory materials and equipment for medical and health research centers in Iran.

Words of Advice: choosing the right lab for your post-doctoral fellowship.

For most researchers, the time they spend as a postdoc stands out as one of challenge, but also enormous personal and professional growth. This Words of Advice is intended to guide the choice of postdoctoral position to help make the venture a success and to launch the first chapter of a happy and fulfilling professional life.

Laboratory Perspective on Racial Disparities in Sexually Transmitted Infections.

BACKGROUND: Rates of sexually transmitted infections (STI) have risen steadily in recent years, and racial and ethnic minorities have borne the disproportionate burden of STI increases in the United States. Historical inequities and social determinants of health are significant contributors to observed disparities and affect access to diagnostic testing for STI. CONTENT: Public health systems rely heavily on laboratory medicine professionals for diagnosis and reporting of STI. Therefore, it is imperative that clinicians and laboratory professionals be familiar with issues underlying disparities in STI incidence and barriers to reliable diagnostic testing. In this mini-review, we will summarize contributors to racial/ethnic disparity in STI, highlight current epidemiologic trends for gonorrhea, chlamydia, and syphilis, discuss policy issues that affect laboratory and public health funding, and identify specific analytic challenges for diagnostic laboratories. SUMMARY: Racial and ethnic disparities in STI in the US are striking and are due to complex interactions of myriad social determinants of health. Budgetary cuts for laboratory and public health services and competition for resources during the COVID-19 pandemic are major challenges. Laboratory professionals must be aware of these underlying issues and work to maximize efforts to ensure equitable access to diagnostic STI testing for all persons, particularly those most disproportionately burdened by STI.

American Society for Clinical Pathology's 2019 Wage Survey of Medical Laboratories in the United States.

OBJECTIVES: To inform the pathology and laboratory field of the most recent national wage data. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. METHODS: The 2019 Wage Survey was conducted through collaboration of the American Society for Clinical Pathology (ASCP) Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. RESULTS: Compared with 2017, results show an overall increase in salaries for most laboratory occupations surveyed except cytogenetic technologists, laboratory information systems personnel, and performance improvement or quality assurance personnel. Geographically, laboratory professionals from urban areas earned more than their rural counterparts. CONCLUSIONS: As retirement rates continue to increase, the field needs to intensify its efforts on recruiting the next generation of laboratory personnel. To do so, the report urged the field to highlight advocacy for better salaries for laboratory personnel at the local and national levels when developing recruitment and retention strategies.

Thyroid Hormone Tests Ordering Practice and Cost-Effectiveness in Samples Referred to International Clinical Laboratories from Addis Ababa Health Facilities.

BACKGROUND: Thyroid dysfunction accounts for majority of endocrine disorders. In sub-Saharan Africa Graves' disease and hypothyroidism have accounted for 13.1% and 8.8% while the burden of thyroid disorder has ranged from 6.18 to47.34% among countries in the Arab world. The cost for a primary thyroid test done to evaluate the gland function constituted a large proportion of the public health budget. For instance, 10 million thyroid functions have been done each year by laboratories which cost 30 million UK pounds, and they represent 8% of laboratory charge in the US. When a TSH-only protocol (guideline) was used, 95% of the requests were sufficient for diagnosis without requiring further tests, thereby resulting in 50% savings on FT4 reagent and reducing the annual TFT reagent cost by 25%. This is an original study, and its objective was to assess the ordering pattern of TSH tests and their cost-effectiveness in patients' samples referred to ICL from Addis Ababa health facilities between July2015 to June 2016. METHOD: An institution-based cross-sectional study design was utilized to study the ordering pattern of thyroid function tests using one-year retrospective data from ICL. RESULTS: Thyroid profiles were ordered more frequently (49.5%) compared to TSH only (24.3%). An additional 2625.70 USD was paid by patients for individual components in the profile tests that turned out normal. CONCLUSION: Guidelines advocate TSH as the initial test for thyroid dysfunction, but the use of a combination of tests is more common.

The Development of New Diagnostic Tests for Neurologic Disorders in the Commercial Laboratory Environment.

Development of new diagnostic tests in a commercial laboratory for neurologic disorders is challenging. Development occurs in a highly regulated environment. Relevant research infrastructure may not be readily available in-house and may require outsourcing with additional management and costs. Clinically characterized specimens for validation of biomarkers for esoteric diseases may be difficult to acquire, and market size may be difficult to predict. More common diseases with heterogeneous subsets may require better clinical definition. Absence of guidelines may delay health provider acceptance of novel testing. Regulatory agency approval and categorization of tests affects validation requirements and impacts market acceptance and reimbursement.

Cost of decentralized CAR T-cell production in an academic nonprofit setting.

Chimeric antigen receptor (CAR) T-cell therapy is a promising immunotherapy with high acquisition costs, and it has raised concerns about affordability and sustainability in many countries. Furthermore, the current centralized production paradigm for the T cells is less than satisfactory. Therefore, several countries are exploring alternative T-cell production modes. Our study is based on the T-cell production experience in a nonprofit setting in Germany. We first identified the work steps and main activities in the production process. Then we determined the fixed costs and variable costs. Main cost components included personnel and technician salaries, expenditure on equipment, a clean room, as well as production materials. All costs were calculated in 2018 euros and converted into U.S. dollars. For a clean room with one machine for closed and automated manufacturing installed, annual fixed costs summed up to approximately €438 098 ($584 131). The variable cost per production was roughly €34 798 ($46 397). At the maximum capacity of one machine, total cost per product would be close to €60 000 ($78 849). As shown in the scenario analysis, if three machines were to be installed in the clean room, per production cost could be as low as €45 000 (roughly $59905). If a cheaper alternative to lentivirus was used, per production total cost could be further reduced to approximately €33 000 (roughly $44309). Decentralized T-cell production might be a less costly and more efficient alternative to the current centralized production mode that requires a high acquisition cost.

The corporatization of dermatopathology.

The corporatization of dermatopathology has long preceded that of dermatology and has been driven by federal legislation and economic influences. Although the Clinical Laboratory Improvement Amendments and the Stark Law limited physician-owned laboratories, loopholes via the Safe Harbor Exemptions outlined in the Anti-Kickback Statute allowed corporate laboratories to flourish through relationships built by health information technology donations. The rise of corporatization has had widespread effects on the fields of dermatopathology and dermatology, resulting in reduced numbers of dermatology-trained dermatopathologists and decreased caseloads in academic institutions, potentially compromising dermatology residency education. Although there have been efforts to counteract these effects, more global changes will be required to alter the direction of this subspecialty.

ElectroPen: An ultra-low-cost, electricity-free, portable electroporator.

Electroporation is a basic yet powerful method for delivering small molecules (RNA, DNA, drugs) across cell membranes by application of an electrical field. It is used for many diverse applications, from genetically engineering cells to drug- and DNA-based vaccine delivery. Despite this broad utility, the high cost of electroporators can keep this approach out of reach for many budget-conscious laboratories. To address this need, we develop a simple, inexpensive, and handheld electroporator inspired by and derived from a common household piezoelectric stove lighter. The proposed "ElectroPen" device can cost as little as 23 cents (US dollars) to manufacture, is portable (weighs 13 g and requires no electricity), can be easily fabricated using 3D printing, and delivers repeatable exponentially decaying pulses of about 2,000 V in 5 ms. We provide a proof-of-concept demonstration by genetically transforming plasmids into Escherichia coli cells, showing transformation efficiency comparable to commercial devices, but at a fraction of the cost. We also demonstrate the potential for rapid dissemination of this approach, with multiple research groups across the globe validating the ease of construction and functionality of our device, supporting the potential for democratization of science through frugal tools. Thus, the simplicity, accessibility, and affordability of our device holds potential for making modern synthetic biology accessible in high school, community, and resource-poor laboratories.

Strengthening Public Health in Wisconsin Through the Wisconsin Clinical Laboratory Network.

The Wisconsin Clinical Laboratory Network (WCLN) at the University of Wisconsin-Madison is a partnership of 138 clinical and public health laboratories (as of February 2019) coordinated by the Wisconsin State Laboratory of Hygiene. This article describes the WCLN, its current activities, and lessons learned through this partnership. A laboratory technical advisory group, which consists of representatives from clinical laboratories, provides clinical laboratory perspective to the WCLN and fosters communication among laboratories. Activities and resources available through the WCLN include annual regional meetings, annual technical workshops, webinars, an email listserv, laboratory informational messages, in-person visits by a WCLN coordinator to clinical laboratories, and laboratory-based surveillance data and summaries distributed by the Wisconsin State Laboratory of Hygiene. One challenge to maintaining the WCLN is securing continual funding for network activities. Key lessons learned from this partnership of more than 20 years include the importance of in-person meetings, the clinical perspective of the laboratory technical advisory group, and providing activities and resources to clinical laboratories to foster sharing of data and clinical specimens for public health surveillance and outbreak response.