key: cord-0794966-g3opa698
authors: Wells, Wendy A.; Harhen, Michael T.; Calderwood, Michael S.; Altomare, Antonia L.; Huntington, Jonathan T.; Merrens, Edward J.; Tsongalis, Gregory J.
title: Maintaining Laboratory Services in a Rural Academic Medical Center During the SARS-CoV-2 Pandemic: What Worked and What Did Not (February 29–May 1, 2020)
date: 2020-07-19
journal: nan
DOI: 10.1016/j.yamp.2020.07.001
sha: 2c85cbea5eb75e3e93c0e536d323e001b354085a
doc_id: 794966
cord_uid: g3opa698

In this crisis, leaders are not made, they are revealed

employees and vulnerable members of society should be protected from unnecessary exposures. A critical part of our early statewide response to this crisis was the coordinated decision-making of laboratory medicine, infectious disease and epidemiology experts at the Dartmouth-Hitchcock Medical Center (DHMC).

Dartmouth-Hitchcock Health (D-HH), a nonprofit academic health system, provides primary as well as tertiary and quaternary health care to a rural population base of 1.5 million individuals coming from a wide geographic area in New Hampshire and eastern Vermont.

Cotton Comprehensive Cancer Center, D-HH employs more than 1,500 primary care doctors and specialists and 500 advanced practitioners in almost every area of medicine throughout the health system, with major community practice locations throughout NH. D-HH is the largest employer in NH aside from the state itself.

In the last decade, the United States has responded to the threats of the H1N1 influenza The laboratory for Clinical Genomics and Advanced Technology (CGAT), within the Department of Pathology and Laboratory Medicine at DHMC, is supported by a director, physician and doctoral level assistant directors, and highly trained technologists. CGAT offers a diverse spectrum of high complexity DNA testing for genetic diseases, infectious diseases, hematologic diseases, oncology and pharmacogenomics. As a CLIA-certified, CAP-accredited clinical laboratory, CGAT maintains a high level of quality assurance through technical, administrative, and structural mechanisms. Institutional investment in this infrastructure over the last 10 years ensured a readiness that was crucial to our rapid response in this pandemic crisis. With this investment and expertise, three new, diagnostic SARS-CoV-2 molecular assays were developed and validated in-house to meet the needs of high-throughput testing (symptomatic outpatients) and lower volume rapid testing (symptomatic in-patients and triaging from the Emergency Department). Choosing the right test, evaluating the best instrument on which to run it, and predicting the availability of reagents and other supplies were all keys to allow the institution to remain immune to manufacturer and federal promises that could not match demand as the pandemic spread. An appreciation of the technical time and effort needed to offer SARS-CoV-2 testing throughout the state -stretching from covering one shift to three -resulted in a better understanding by many providers of the complexity of the testing. Protective Equipment (PPE) that health care workers would need to wear while caring for infected patients. Over the next 6 weeks, 3,500 employees were trained in all forms of PPE. We started to coordinate a response with our regional system members, as well as with the states CGAT went live with the CDC assay (2 runs per day, 12-24 hour resulting after specimen receipt in laboratory) on March 17 and the Abbott m2000 assay (4 runs per day, 12-24 hour resulting) on March 24 [1] . In the State of VT, a "stay-home-stay-safe" requirement went into effect on March 25 followed, the next day, by VT school closures for the rest of the academic year. On March 27, a NH "stay-at-home" requirement and closure of schools went into effect.

By March 28, confirmed US deaths from coronavirus doubled from 1000 to 2000 in 2 days, with more than 55,000 confirmed cases in NY, 4,257 confirmed cases in MA and 1,524 in CT. By

March 30, 27 states had "stay-at-home" orders.

As of April 29, 2020, the number of active cases in the United States had risen to 1,012,583 with 58,355 deaths ( Table 1) 

Clinical laboratories are held accountable by numerous national and federal accrediting bodies (CAP, FDA, AABB, FACT, CMS). We provide millions of quality test results and interpretations to diagnose, treat and monitor human disease in a highly efficient environment.

We serve the needs of every department by competently operationalizing complex workflows to get specimens delivered to the laboratory for testing. However, we often remain the "silent partner." The public (even those in the medical field) do not know what clinical laboratories are and the role we play in medicine today. This pandemic crisis changed that, shining a bright light of public attention and putting "testing" at the forefront of our national response. Our efforts to provide the testing needed to identify, isolate and treat SARS-CoV-2 positive patients were both facilitated and challenged. The following worked well. • SARS-CoV-2 test ordering control: Early on during the surge planning, DH-IC decided to limit the providers who were allowed to order a SARS-CoV-2 test. This standardized the test requests and provided clean, clinically-relevant data. It also helped the institution better understand the need for test assays with shorter and shorter result turnaround time to enable patient triaging from the ED.

• Emergency capital requests: DH-IC immediately approved any capital, test reagents and supplies purchases to bring up SARS-CoV-2 molecular testing capabilities, serology testing and convalescent plasma treatment through our departmental Apheresis/Blood Donor Program. By May 1, the products received and invoiced totaled $1,343,275 with additional purchase orders issued for $3,683,849 to sustainably meet the increased need for PCR-based and antibody-based SARS-CoV-2 testing ( Table 2 ).

• Supply chain: DH-IC assigned the clinical laboratories a dedicated Supply Chain representative to facilitate, wherever possible, the rapid acquisition of contracts, capital, reagents and PPE.

• Access to State Relief funds for testing capital and supplies: DH-IC ensured that the clinical laboratories had immediate access to "Letters-of-Need" from our Chief Legal

Officer & General Counsel for State to justify state relief funds.

supervisors, a quality manager, the client response team, phlebotomy and the laboratory Specimen Receiving staff from every hospital laboratory in the health system -helped identify and coordinate responses to staffing shortages, risk assessments, test run times, couriers, and critical supplies like swabs, universal transport medium and PPE. Initially meeting by WebEx at the same time daily (between March 16-20), the meetings were spread out to three times a week, starting March 23. The cooperation between our regional health system laboratories was swift and comprehensive. 4. Nimble and responsive lab testing and validation: When faced with shortages of swabs, out lab worked to validate other potential swabs. With a national shortage of viral transport media, our lab developed our own media. In ongoing reductive work, the lab developed mechanisms and validations on dry swabs that did not require transport media.

WHAT DID NOT WORK:

CoV-2 pandemic were hindered by erroneous and conflicting national information as to the availability and validity of the coronavirus diagnostic test. This confused and misled not only our patients, but our staff and many providers. Areas of particular confusion included:

• Recognizing the difference between a diagnostic test on symptomatic patients (for which our assays were validated) versus a screening test in an asymptomatic population.

• Trying to explain the nuances of what a robust new assay validation entails so that better comparisons and contrasts can be made with the Emergency Use Authorization (EUA) products that have flooded the market since March 2020.

• Distinguishing between specimen sampling and testing: Specimen sampling took place at sites throughout the state but testing for D-H patients was only performed at DHMC.

• Understanding that accurate test resulting depends on appropriate and competent sampling, and that the result turnaround time depends on the transport time to the laboratory where testing will occur, receipt and preparation of that specimen, the assay and instrumentation used, the technical expertise required to perform these highly complex molecular tests across multiple shifts, and appropriate resulting into the patient's EMR (or other methods of submitting results back to providers if the specimens have come from non-affiliated collection centers).

2. NH State politics: While we continued to work collegially and professionally with our NH State Laboratory to clear state-testing backlogs and share reagents and supplies, political decisions about testing sometimes over-ruled sound, evidence-based science. State Health Alerts and Advisories from adjacent NH and VT were often uncoordinated which resulted in different testing strategies for hospitals situated on the state borders. While physically being treated at our institutions in NH, we were required to abide by the testing requirements of the state of VT for residents in that state.

3. Elective surgery planning: Carefully-considered, evidence-based test triaging by DH-IC, based on CDC published guidelines, was mis-interpreted by providers in the name of published statements by their professional associations (ACOG, ACS, ASA, AORN, AHA) [2, 3] . It took the influence of DH-IC to raise awareness that appropriate PPE was always made available to our providers and that a test performed on an asymptomatic patient coming in for elective surgery was not what the SARS-CoV-2 molecular test was validated for. 4 . School and Daycare closures: When local school and daycare centers closed, the impact on the ability of both staff and faculty to continue to provide patient services was profound. When elective surgeries were suspended, the reduction in specimen volumes allowed flexibility in coverage in the clinical laboratories. With the return to elective surgeries, and a ramp up in ambulatory testing while schools and daycare centers remained closed, staffing the coverage of key services remained a challenge. Efforts by the College of American Pathologists to get CMS approval for surgical pathologists to sign out surgical cases from an office at home, as well as render primary diagnoses from digital images [4] enabled more flexibility for faculty to get back to work.

Through the early establishment of a Dartmouth-Hitchcock Incident Command (D-H IC), planning for a surge in SARS-CoV-2 cases in NH was highly efficient, building upon prior institutional preparations for the monitoring of new, emerging infections. The proactive and visionary work of molecular diagnostic teams in the D-H clinical laboratories resulted in us being able to validate an array of new diagnostic test platforms for SARS-CoV-2, to meet the turnaround time and sensitivity needs of the regional population that we serve. We used our existing regional laboratory infrastructure to coordinate testing strategies, reagents and supplies. A respectful and supportive relationship with the NH State laboratory maintained a consistently fast SARS-CoV-2 test result turnaround time, statewide. We met the challenges head-on and were not overwhelmed. 

Implementation of an Emergency Use Authorization Test During an Impending National Crisis

Practice Advisory, Novel Coronavirus

Association of periOperative Registered Nurses, American Hospital Association

CAP Secures Remote Work Waiver for Pathologists: College of American Pathologists (CAP) Advocacy Update