Until treatment and vaccine for coronavirus disease-2019 (COVID-19) becomes widely available, other methods of reducing infection rates should be explored. This study used a retrospective, observational analysis of deidentified tests performed at a national clinical laboratory to determine if circulating 25-hydroxyvitamin D (25(OH)D) levels are associated with severe acute respiratory disease coronavirus 2 (SARS-CoV-2) positivity rates. Over 190,000 patients from all 50 states with SARS-CoV-2 results performed mid-March through mid-June, 2020 and matching 25(OH)D results from the preceding 12 months were included. Residential zip code data was required to match with US Census data and perform analyses of race/ethnicity proportions and latitude. A total of 191,779 patients were included (median age, 54 years [interquartile range 40.4–64.7]; 68% female. The SARS-CoV-2 positivity rate was 9.3% (95% C.I. 9.2–9.5%) and the mean seasonally adjusted 25(OH)D was 31.7 (SD 11.7). The SARS-CoV-2 positivity rate was higher in the 39,190 patients with “deficient” 25(OH)D values (<20 ng/mL) (12.5%, 95% C.I. 12.2–12.8%) than in the 27,870 patients with “adequate” values (30–34 ng/mL) (8.1%, 95% C.I. 7.8–8.4%) and the 12,321 patients with values ≥55 ng/mL (5.9%, 95% C.I. 5.5–6.4%). The association between 25(OH)D levels and SARS-CoV-2 positivity was best fitted by the weighted second-order polynomial regression, which indicated strong correlation in the total population (R² = 0.96) and in analyses stratified by all studied demographic factors. The association between lower SARS-CoV-2 positivity rates and higher circulating 25(OH)D levels remained significant in a multivariable logistic model adjusting for all included demographic factors (adjusted odds ratio 0.984 per ng/mL increment, 95% C.I. 0.983–0.986; p<0.001). SARS-CoV-2 positivity is strongly and inversely associated with circulating 25(OH)D levels, a relationship that persists across latitudes, races/ethnicities, both sexes, and age ranges. Our findings provide impetus to explore the role of vitamin D supplementation in reducing the risk for SARS-CoV-2 infection and COVID-19 disease.

Authors: Harvey W. Kaufman, Justin K. Niles, Martin H. Kroll, Caixia Bi, Michael F. Holick

Published: September 17, 2020

https://doi.org/10.1371/journal.pone.0239252

Click here to read the article.

As steward of analytical health, the clinical laboratory is uniquely positioned to lead and/or contribute to strategic integrated clinical care initiatives that drive measurably better healthcare.

Two leading experts with globally recognized best practices in this area are Dr. Ellie Dow, Consultant in Biomedical Medicine, Blood Sciences at Ninewells Hospital and Medical School Tayside (Dundee, Scotland) and Dr. Tim James, head biomedical scientist in the Clinical Biochemistry Department at the John Radcliffe Hospital (Oxford, England).
Among many commonalities, both leaders are active champions with proven success on the power of laboratory medicine to drive advancements in patient care, clinical decision-making, strategic problem solving and healthcare excellence. In 2019, both were independent and elite recipients of the 2019 UNIVANTS of Healthcare Excellence Awards and have more recently, joined as guest editors for a special issue in the eJIFCC on Measurably Better Healthcare Performance.

For those interested in learning more about the special issue or submitting a manuscript on this topic, please email your manuscript to ejifccspecialissue@gmail.com and ejifcc@ifcc.org by November 15, 2020. For those interested in learning more about the UNIVANTS of Healthcare Excellence Awards and/or the globally-recognized best practices associated with the healthcare excellence program, including those from Dr. Ellie Dow
and Dr. Tim James, please visit www.UnivantsHCE.com.

How important is the clinical laboratory in healthcare today?

Tim:

There is no better evidence of the importance of laboratories in healthcare today than our integral role in responding to the COVID-19 pandemic. Initial diagnosis, management of patients through the escalation of treatment, and population assessments are all dependent on the clinical laboratory. Equally, as we emerge from the COVID-19 peak, the agenda for re-establishing the ‘new’ normal will require re-engagement of what laboratory services can offer in re-engineered patient pathways. I believe this is a great opportunity for all of us.

Ellie:

The clinical laboratory is the engine hidden under the hood of care – without this, the car doesn’t go anywhere. Clinicians can still use their clinical acumen and diagnostic skills, but there is no reassurance or confirmation without laboratory diagnostic testing. Last year, we had a lightning strike that completely took out our local laboratory service, and without the ability to send samples to a nearby sister hospital, which retained some functions, it is likely that our hospital would have closed to acute admissions. Our medical staff were flying blind, and truly valued when we were able to resume service as usual.

What advice do you have for clinical laboratory teams who are aiming to be more strategically involved in their health systems?

Tim:

Make yourself available to service users and ensure that you are easy to contact. When I look at some websites, I struggle to find the contact names for the laboratory – almost as if by design.

This is true even for laboratory-based websites, so if someone wanted to discuss any issue with the lab team, there are immediate barriers already. Equally as important is pro-actively and positively following up with all contact opportunities whenever possible, whether it is within clinical, management or academic settings.

Ellie:

It’s really about getting out of the office and out of the lab, making and expanding those cross-discipline connections, and building those networks. In addition, in-person contact – as much as possible – cannot be under-estimated for establishing rapport and trust. If in-person meetings are not possible or restricted during this pandemic, face to face contact over video calls is still more ideal than the remote use of emails.

What critical success factors have worked best for you and your teams?

Tim:

Following through with what you say you would do. When resources are stretched, it can be difficult to keep up with all the commitments asked of us, but if you deliver on them, it builds trust and confidence in your services. More critical, however, is the importance of the teams –building them, sharing difficulties and making sure that successes are communicated and positively reinforced.

Ellie:

Lots of regular contact, often face to face including informal “drop-in” meetings and exchanging ideas; these collective factors help ensure that everyone on the team feels valued in their role.

What is the first step to getting started?

Tim:

Be realistic and deliver on a small number of user engagements well. Do not take on too much too soon and don’t be disappointed in yourself if it doesn’t always work…but rather learn from all you do through reflection.

Ellie:

If you’re new to your institution, or new to this style of working, then I would recommend getting out the lab and talking to people at as many local meetings as you can – whether clinical, managerial or academic meetings. Be approachable and keen, show that you have a “can-do” attitude and want to make things work and solve problems. Speaking at local grand rounds is also excellent for expanding networks and participating (or even driving) new team discussions!

How have your best practices made a difference to your patients, health systems
or to you and your teams personally?

Tim:

The work we have undertaken on pre-eclampsia markers has had a high profile because of the short time between our study work (mainly the INSPIRE study) and translation into routine practice. This resulted in follow up interactions from around the world to both the lab and the obstetric teams, helping others establish similar services. The effort has therefore not only benefit patients in our hospital, but across the UK and globally. I think our entire team has each had a “feel-good” factor as a consequence of our work together.

Ellie:

We know that patients in Tayside are getting properly investigated for abnormal liver function, and the strength of the programme is recognized nationally. We’re getting the right patients at our liver clinics.

For the team, we have more confidence, and are known to our senior management. The core laboratory team all play a role in making our programme work smoothly and share in its success. For me personally, I’ve had lots of opportunities to travel globally while presenting on the team outcomes and meeting many wonderful people.

What types of manuscripts would you like to see submitted to the eJIFCC special issue on Measurably Better Healthcare?

Tim:

Manuscripts that capture quality improvements well in terms of outcomes. This may be a quality metric within the lab, but it would be stronger if it showed shared involvement with clinical teams. Early in my career, probably 30 years ago, we worked on improvements to communication of test results with our clinical teams with a primary outcome of an 80% reduction in phone calls which both clinicians and the laboratory felt were unnecessary. The manuscript describing this never got published, as reviewers felt we could not identify the relative contribution of the concurrent changes that we had made. Scientifically, I understand that position completely now, but as a poster presentation, it raised more discussion and engagement than anything else I have done subsequently. So, I guess I am interested in capturing scientifically sound manuscripts which share good ideas and open discussion.

Ellie:
Manuscripts that show the strength of clinical and laboratory teams working together to improve healthcare, no matter in what setting, with measurable KPIs appropriate to the project and setting, whether that’s rural Africa or a clinic in Europe. Demonstrably better healthcare together!

Source: ifcc.org/media/478602/ifccenewsseptember2020

The Electronic Journal of IFCC (eJIFCC) is indexed by PubMed Central® (PMC)

1. Call for manuscript submissions for a thematic eJIFCC issue on “Measurably Better Healthcare”

2. A conversation between two viruses: SARS-CoV and SARS-CoV-2 – based on a true story

Eleftherios P. Diamandis

3. Robinson Crusoe never had to meet academic deadlines: scholarly pressure in the age of COVID-19

Nina Maria Fanaropoulou

4. The natural history of an eponym: the Malloy-Evelyn method
Larry J. Kricka, Jason Y. Park

5. Leptin levels and Q223R leptin receptor gene polymorphism in obese Mexican young adults

Carlos E. Diéguez-Campa, Luis I. Angel-Chávez, David Reyes-Ruvalcaba, María J. Talavera-Zermeño, Diego A. Armendáriz-Cabral, Dayanara Torres-Muro, Iván Pérez-Neri

6. Extra-analytical clinical laboratory errors in Africa: a systematic review and meta-analysis

Daniel Asmelash, Abebaw Worede, Mulugeta Teshome

7. Vitamin D deficiency has no impact on PSA reference ranges in a general university hospital – a retrospective analysis

Zoltán Tóth, Balázs Szalay, Béla Gyarmati, Dlovan Ali Jalal, Barna Vásárhelyi, Tamás Szabó

8. Trends in laboratory testing practice for diabetes mellitus

Mithu Banerjee, Samuel Vasikaran

9. Anti-tuberculosis treatment: induced hepatotoxicity – a case report

Poludasari Shravan Kumar, Rachakonda Vidya, Tabassum, Manashwini Jageer

10. Case report on pediatric septic arthritis of the hip

Shireen Prince, Rao Tulasi

11 Retraction of Publication
Editor of the eJIFCC

Click to download the PDF of the full issue

If you missed the webinar on IFCC guidelines on Molecular, Serological, and Biochemical/Hematological Testing or want to re-attend it, it is now available freely available on-demand through: https://www.workcast.com/AuditoriumAuthenticator.aspx…

If you have not registered yet, register first here: https://www.workcast.com/register?cpak=6827351465814213

The COVID-19 pandemic has drawn attention to clinical laboratory testing as never before. Journalists, public officials, and people worldwide now understand that testing is key to managing the crisis. What are the images associated with this conviction? Gowned workers acquiring nasal swabs, often through car windows, are commonly portrayed in the media. 

But what about the actual analysis once the specimen is received in the laboratory? The scientific complexity underlying the most common test for SARS-CoV-2 belies the simplicity of the specimen, and the eagerly awaited positive or negative result. But the complexity of the analyses performed behind the scenes by clinical laboratory professionals are not typically communicated to the public. 

The adaptation of the polymerase chain reaction for diagnosis of COVID-19 and the genetic sequencing of the virus necessary for its development will stand as paired achievements transforming the history of the pandemic. Nearly 1 million tests per day are currently performed in the clinical labs (hospital, proprietary, and public health) of the US, providing data to drive the public health response. Guided by the application of basic science, the historic mission of the clinical laboratory, and commitment to patient outcomes, the skilled professionals of the laboratory community have proceeded to this stage without fanfare, even as logistical barriers, supply chains, and regulatory disfunction have produced roadblocks.

What do clinical laboratory professional do?

While physicians, nurses, and first responders are rightfully hailed as heroes, practitioners who do not interact with patients most often remain unseen and unexamined. In a long campaign to achieve New York State licensure for clinical lab professionals in 2005, advocates often cited the figure 70 percent as the contribution of clinical lab results to the average medical diagnosis. We should not miss the opportunity to educate the public to the critical role of lab testing in their health care.

Considering only COVID-19, on top of the massive task of diagnostic and epidemiologic screening, hospitalized patients need dozens of additional lab tests per day to manage volatile clinical situations. Tests are scientifically interdisciplinary, and require the full spectrum of technical skill, from manual to robotic applications. Gauging the immune status of patients and the wider population also falls to clinical labs. This involves a rapidly changing mix of analyses to measure anti-viral antibody, cellular immunity, and markers of inflammation. If risk of infection is associated with patient contact, it is also significant for laboratory practitioners. Patient specimens, the starting point of every analysis, are the concentrated expression of the pathogens they may contain. Universal precautions that guide care in infectious disease derive from another pandemic in our time (HIV/AIDS) in which lab personnel were found to contract workplace infections more frequently than other healthcare providers.

Who are clinical laboratory professionals and what is their path to the lab? 

Medical laboratory technologist, a profession in which the baccalaureate is the entry level, allows young science graduates to achieve fiscal stability without the persistent debt that derails futures. Graduate opportunities (i.e. biomedical lab management, cytotechnology) and alternative pathways to licensure (i.e. advanced certificates), provide career ladders to keep talent in the lab, and leadership to the profession. 

A more prominent depiction of the clinical lab profession emerging from the COVID-19 outbreak could attract more students nationally. University administrators will be persuaded that investment in costly scientific education bears rewards. Patients will be better advocates for a healthcare system they understand in more depth.

Clinical lab professionals are proud of their contribution. Ricky Kwan (BS, MS/MLS) manages laboratory information systems at Mount Sinai Medical Center in NYC. He says, “I believe the COVID-19 pandemic shows the importance of clinical lab services to the overall treatment outcome of the patient. Clinical Lab Services are sometimes known as the “forgotten warriors” in the fight to save a patient’s life.  We provide the crucial data to doctors which drives their choice for the best treatment option. We need to celebrate the work that clinical laboratorians do.” 

Author: Regina Linder, PhD

Regina Linder (BS, CCNY; MS, UMass; PhD, NYU) is Professor Emerita, Medical Laboratory Sciences (MLS), Hunter College (CUNY). A medical microbiologist, her research focuses on the collaborative cytotoxins of pathogenic and commensal bacteria, insects and marine organisms. At Hunter since 1982, Regina taught clinical microbiology and served as program director of MLS from 1989 to 2007. Academic program development after formal retirement yielded new graduate degrees. We are immensely proud of MLS alumni who are crucial to the COVID-19 response in NYC.

Source: clinicallabmanager.com/thought-leadership/the-clinical-lab-and-covid-19-whats-happening-behind-the-scenes