Context.—

Declining reimbursement shifts hospital laboratories from system assets to cost centers. This has resulted in increased outsourcing of laboratory services, which can jeopardize a hospital systems' ability to respond to a health care crisis.

Objectives.—

To demonstrate that investment in a core laboratory serving an academic medical center equipped a regional health system to respond to the Coronavirus disease 2019 (COVID-19) pandemic.

Design.—

COVID-19 diagnostic testing data were analyzed. Volumes were evaluated by result date (March 16, 2020–May 6, 2020), and the average of received-to-verified turnaround time was calculated and compared for in-house and send-out testing, and different in-house testing methodologies.

Results.—

Daily viral diagnostic testing capacity increased by greater than 3000% (from 21 tests per day to 658 tests per day). Total viral diagnostic testing reported by the core laboratory increased by 128 times during 22 days of test method validation and 826 times during the analysis period, while average turnaround time per day for send-out testing increased from 3.7 days to 21 days. Decreased overall average turnaround time was observed at the core laboratory (0.45 days) versus send-out testing (7.63 days) (P < .001).

Conclusions.—

Investment in a core laboratory provided the health system with the necessary expertise and resources to mount a robust response to the pandemic. Local access to testing allowed rapid triage of patients and conservation of scarce personal protective equipment (PPE). In addition, the core laboratory was able to support regional health departments and several hospitals outside of the system.

In the current health care environment with decreased reimbursements1  and increased focus on the provision of value-based medical services, many hospitals struggle to keep their doors open and provide local access to care.2  Outsourcing of nonclinical support work in hospitals has been on the rise for years in the United States3  and has now spread to clinical services with laboratory, pharmacy, and radiology commonly targeted.4  Continued downward pressure on reimbursements has shifted laboratories from system assets to cost centers.5  This increases the burden on hospital-based laboratories to provide value to their organizations and invites chief financial officers to outsource some or all of their laboratory services.4  Others have discussed the importance of regional “sentinel” laboratories in the event of a pandemic or health crisis6  as well as the presence of a strong systemwide integrated laboratory service line to maintain laboratory operations in times of crisis.7  The outsourcing of laboratory services has also been described, most recently as it relates to academic medical centers.8  Sentinel clinical laboratories are defined as laboratories that are certified to provide high-complexity microbiology testing as part of the laboratory response network to support the public health laboratory system. To the author's knowledge, no one has discussed what the potential effects of outsourcing, leading to a lack of sentinel laboratory services, would have during a health care crisis such as the current pandemic.

As one of the nation's leading academic medical centers with an expanding hospital network, the regional health system described here consists of 6 hospitals and covers a 95-mile radius. This includes the flagship hospital at the medical center, which is an 886-bed facility that provides high-level tertiary care to the region. The remaining hospitals in the enterprise range from a 261-bed inner-city hospital offering some tertiary services to a 15-bed acute care community hospital in a rural setting.

System leadership made the decision to invest in their laboratory infrastructure by building a large core laboratory to support the regional health system clinical enterprise. The core laboratory was completed in June 2019 and serves the clinical enterprise and surrounding region, including 48 nursing homes. It is a 157 400 square foot state-of-the art facility providing clinical pathology services with implementation of large-scale automation in chemistry, hematology, and microbiology. The investment was made with the goals of increased efficiency and standardization while enabling local access to high-quality specialized testing.9 

The coronavirus disease 2019 (COVID-19) is the cause of an ongoing global pandemic that was first reported as a disease outbreak in early January 2020.10  The first case diagnosed in the United States presented on January 19, 2020,11  and declaration of a public health emergency of international concern was issued on January 30, 2020, by the World Health Organization. The first case in the geographic area covered by the clinical enterprise was diagnosed on March 11, 2020. It quickly became obvious that the virus was spreading rapidly enough to overwhelm the testing capabilities of our state and local health departments, speaking to the need for access to prompt diagnostic testing.12  Shortages of PPE, testing supplies, and semiprivate patient rooms made it necessary to cohort patients into different groups on the basis of risk assessment and testing status. This further compounded the demand for access to rapid and accurate diagnostic testing.13  In coordination with the State Department of Health, work was begun immediately on the development of Emergency Use Authorization (EUA)–approved testing to bring in-house at the core laboratory.

DESIGN

During the course of 22 days from March 11, 2020, to April 2, 2020, the core laboratory was able to validate and implement testing by using 5 different assays (Figure 1). The state health department, with permission from the US Food and Drug Administration (FDA), designated certain laboratories throughout the state to implement the Centers for Disease Control and Prevention (CDC) EUA 2019-Novel Coronavirus (2019-nCoV) real-time polymerase chain reaction (RT-PCR) diagnostic test. With assistance from the state, the core laboratory was able to validate and perform this diagnostic test within 5 days of the sentinel case in the region. The protocol used 3 different CDC-approved RNA extraction methods and the reverse transcribed cDNA was amplified in the Thermo Fischer Scientific Applied Biosystems 7500 Fast Dx Real-Time PCR instrument. This was followed by validation of the DiaSorin Molecular Simplexa COVID-19 Direct real-time RT-PCR assay performed on the LIAISON MDX instrument for the in vitro qualitative detection of nucleic acid, 9 days later. Within less than 2 weeks the laboratory was able to implement high-throughput automated testing with the Roche cobas SARS-CoV-2 on the Roche cobas 8800 System, giving us the capability to drastically increase our volumes (to the extent that reagent and supplies were available). These methods were followed by validation of SARS-COV-2 on the Cepheid GeneXpert Xpress platform and BioGx SARs-CoV-2 on the Becton Dickinson BD MAX System.

Figure 1

Timeline of diagnostic testing implementation at the core laboratory. *Centers for Disease Control and Prevention (CDC) Emergency Use Authorization (EUA) laboratory-developed test (LDT); □DiaSorin Molecular Simplexa COVID-19 Direct Kit; ⋄Roche cobas SARS-CoV-2 Test; •Cepheid Xpert Xpress SARS-COV-2; ‡Becton Dickinson BioGX SARS-CoV-2.

Figure 1

Timeline of diagnostic testing implementation at the core laboratory. *Centers for Disease Control and Prevention (CDC) Emergency Use Authorization (EUA) laboratory-developed test (LDT); □DiaSorin Molecular Simplexa COVID-19 Direct Kit; ⋄Roche cobas SARS-CoV-2 Test; •Cepheid Xpert Xpress SARS-COV-2; ‡Becton Dickinson BioGX SARS-CoV-2.

Average daily turnaround times (TATs) were calculated from the time the specimen was received in the core laboratory to the time the final result was verified. The TATs were then combined and averaged for all in-house testing platforms and for all send-out testing sites. All testing sent out to reference laboratories added 24 hours to the average received-to-verified TAT. Reference and health department laboratories received-to-verified TAT was averaged to maintain anonymity between laboratories for the purposes of publication. A P value was calculated by performing a Student t test. Volumes of verified results by date as well as TATs for both send-out and in-house testing were graphed to illustrate differences (Figure 2). Average TATs for the 5 platforms used at the core laboratory were also calculated and graphed for illustration (Figure 3).

Figure 2

Combined graph with average turnaround time (TAT) and result volumes for in-house and send-out testing.

Figure 2

Combined graph with average turnaround time (TAT) and result volumes for in-house and send-out testing.

Figure 3

Received-to-verified turnaround time (TAT) by in-house platform (days) (Roche cobas SARS-CoV-2 Test; Cepheid Xpert Xpress SARS-COV-2; Becton Dickinson [BD] BioGX SARS-CoV-2; DiaSorin Molecular Simplexa COVID-19 Direct Kit; Centers for Disease Control and Prevention [CDC] Emergency Use Authorization [EUA] laboratory-developed test).

Figure 3

Received-to-verified turnaround time (TAT) by in-house platform (days) (Roche cobas SARS-CoV-2 Test; Cepheid Xpert Xpress SARS-COV-2; Becton Dickinson [BD] BioGX SARS-CoV-2; DiaSorin Molecular Simplexa COVID-19 Direct Kit; Centers for Disease Control and Prevention [CDC] Emergency Use Authorization [EUA] laboratory-developed test).

RESULTS

While implementing multiple testing platforms at the core laboratory, diagnostic testing was sent out to 5 different reference laboratories as well as the state and local health department laboratories to keep up with demand. Analysis of testing data demonstrated that reference and health department laboratories' average daily TATs were increasing from a low of 3.7 days to a high of 21 days as they were being overwhelmed with testing demand during this period. Taking into account the additional 24 hours for transport to the various reference laboratories, the TAT range was 2.7 days to 20 days. In contrast the core laboratory was able to increase its daily testing capacity by greater than 3000% with resulting viral diagnostic testing volumes per day going from a low of 21 tests per day to a high of 658 tests per day during the analysis period. Total viral diagnostic tests performed by the core laboratory increased by 128 times (from 21 tests to 2694 tests) during the 22 days it took to validate 5 different platforms and by 826 times (from 21 tests to 17 359 tests) during the analysis period, with a decrease in daily average received-to-verified TATs from a high of 1.8 days to a low of 0.14 days (Figure 2). This met the initial demands for testing in our system and by April 2, 2020, when all 5 different assays were running at the core laboratory, the need for reference testing had been eliminated. Statistical analysis of overall average TAT data demonstrated a statistically significant decrease in average TAT when testing was performed at the core laboratory as compared to being sent out to a reference or health department laboratory (0.45 days versus 7.63 days) (P < .001) (Figure 2).

Review of the overall average TAT results by testing platform demonstrated that all testing methodologies performed at the core laboratory had less than an average 24-hour TAT from received to verified with daily average received-to-verified TATs ranging from 0.22 days for the Cepheid GeneXpert Xpress platform to 0.97 days for the CDC 2019-Novel Coronavirus (2019-nCoV) RT-PCR diagnostic panel.

DISCUSSION

Investment in the central laboratory provided the physical space and instrumentation to bring multiple different diagnostic assays into operation to use in parallel. The ability to do this was critical, as the supply chain for different reagents was unpredictable at best. The presence of a large core laboratory at an academic-based health system also enabled attraction and retention of specialized academic faculty who were able to navigate the intricacies of testing on multiple different platforms and provide the highest quality results for our patients. The core laboratory microbiology division is run by a seasoned PhD as well as an MD who trained at a leading academic institution. They are assisted by additional postdoctoral students with expertise in microbiology and laboratory science as well as pathology residents and specialized technical staff. This combination of expertise facilitated the validation process and ensured development of assays with appropriate targets and detection rates. Our faculty experts participated in and led a large portion of the daily emergency command center calls for the system. They interacted with clinical leadership and infection control on a daily basis to develop testing protocols and triage strategies that conserved both testing supplies and PPE to the maximum extent possible. In addition they played a critical role in educating providers about the different assays used and why they were chosen. This was imperative given the combination of tremendous political pressure and medical necessity with the large number of tests that were issued EUA status by the FDA over a short period. Real-time access to faculty experts who were able to interact with clinical leadership to develop testing protocols and provide consultation was invaluable.14  As others8,15  have described, outsourcing clinical laboratory services can lead to loss of clinical faculty and the expert knowledge necessary to implement more complex diagnostic testing.

The pandemic strained the global supply chain, which led to supply shortages and testing backlogs. This forced laboratories to compete with each other for supplies, which led to more downstream breaks in the supply chain.16  In addition, worldwide demand for PPE led to disruption in that supply chain17  and shortages that made rapid access to testing even more critical. The ability to use multiple testing platforms helped us to mitigate the impacts from shortages of testing reagents and supplies, and facilitated the rapid triage of patients. All emergency department patients and inpatients were screened for COVID-19 symptoms. Symptomatic patients underwent diagnostic testing. Testing was sorted in microbiology receiving and run using the fastest available method (Figure 3). All employees in the regional health system were screened daily for symptoms. Other symptomatic diagnostic testing, including essential services and health care workers, was performed on the first available testing platform after the prioritization outlined above. At the time of this analysis asymptomatic testing was not being performed owing to shortages in testing supplies, including swabs, media, reagents, and other consumables. The practices outlined above aided in patient flows throughout the hospitals in the system by decreasing potential exposures of non-COVID patients and staff, and conserving scarce PPE.18  Access to rapid and accurate diagnostic testing for the system allowed the cohorting of both high- and low-risk patients and helped to conserve PPE. Many hospitals and geographic areas in the United States were not so lucky.19 

CONCLUSIONS

It is the experience of the author that testing capability and access to reagents and testing supplies were directly related to the size of the health system and laboratory infrastructure, with smaller nonintegrated health systems experiencing much more difficulty in accessing the necessary equipment and supplies. In our experience small to moderate-sized hospitals in our geographic area outside of a larger health system had almost no choice but to rely on a remote reference laboratory for testing, with many outside of our system reaching out for help. There are many advantages to having a relationship with reference laboratories, such as the provision of esoteric and low-volume testing and the ability to augment testing capacity in times of need. However, it is our observation that the ability to mount a local response to a health care crisis may not be as easy to manage if divestment in the laboratory has gone too far. Investment in a large core laboratory for our system provided us with the space, instrumentation, and expertise that allowed our clinical enterprise to mount a robust response to the pandemic and care for the regional health system patient population. In addition, we were able to provide support to 4 additional hospital systems outside of our immediate area that had no or limited access to testing and augment testing for local health departments that could not keep up with demand.

There is significant likelihood of future pandemics or natural disasters that will require mounting a coordinated response from health systems. The investment in a laboratory that can perform high-complexity testing and rapidly increase capacity in response to demand not only serves the main academic medical center, but also supports the regional health system and public health of the region at large.6  The well-established goals to provide high-quality, efficient care with TATs that can maximally support clinical operations20  are demonstrated here. This would not have been possible if our institution had not invested in its laboratory.

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Author notes

The author has no relevant financial interest in the products or companies described in this article.