Contingency Planning in the Clinical Laboratory: Lessons Learned Amidst COVID-19

Allison B Chambliss, Nicole V Tolan, Contingency Planning in the Clinical Laboratory: Lessons Learned Amidst COVID-19, The Journal of Applied Laboratory Medicine, Volume 5, Issue 4, July 2020, Pages 832–836, https://doi.org/10.1093/jalm/jfaa068

Global transmission of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has faced clinical laboratories with many challenges in continuing to offer critical services. Round-the-clock laboratory testing remains essential to support patient care, both those with and without 2019 coronavirus disease (COVID-19). This pandemic is leading to an influx of hospitalized patients, while simultaneously yielding virus exposures and self-quarantines for the laboratory workforce. Thus, laboratories should prepare to operate with limited staff and may need to prioritize laboratory tests according to clinical necessity.

All laboratories will recognize the need to pay particular attention to those sections involved in SARS-CoV-2 viral testing: upstaffing areas that receive, test, or send out samples, and report/call-back results. However, the laboratory should consider various staffing models to maintain healthy workers, such as altering shift hours, or even alternating staffing groups ( 1). Preemptive scaling back of laboratory staff and enabling them to work from home will allow for creation of a reserve labor pool that can be engaged as staff are required to quarantine with exposure. This is only possible when laboratory testing volumes for tests not relevant to COVID-19 precipitously decrease as hospitals cancel all non-emergent and elective procedures that would otherwise require maintaining higher volumes of comprehensive testing.

The laboratory should begin contingency planning by assessing baseline operational status, which benches can be offered less frequently (batched as sample stability allows), which can be closed altogether, and the resultant minimum number of staff required to support emergent testing (Fig. 1). In order to do so effectively, the laboratory should define which tests are required to support emergent care and inpatient testing. Some resources are available to determine this emergent test menu, such as the World Health Organization’s Model List of Essential In Vitro Diagnostics ( 2,) and the Clinical and Laboratory Standards Institute’s Planning for Laboratory Operations During a Disaster ( 3). However, these resources are not specific to COVID-19, and laboratories should work with medical leadership to ensure that laboratory offerings are aligned with expected testing practices.

Tests that will need to be maintained include complete blood counts, metabolic panels, routine coagulation, troponin, liver function tests, blood gases, and inflammatory markers such as C-reactive protein, lactate dehydrogenase, and procalcitonin ( 4, 5). With laboratory automation, it may be best to prioritize full-time equivalents (FTEs) by assay bench or analyzer, as prioritization of individual tests would require additional work of scrutinizing and separating orders, and sorting, storing, and re-running a large number of samples. It may be most efficient to simply allow an automation line to run the complete battery of tests ordered unless analyte-specific technical issues arise. In times of particularly critical shortages of staff and/or reagents, with proper agreement of hospital leadership and use of mass notification mechanisms, non-emergent tests could be temporarily masked from providers in the test ordering system and eliminate the laboratory from receiving them in the first place.

The laboratory should also evaluate reagent and supply inventory and consider increasing supplies on-hand in preparation for higher test volumes and/or possible lapses in vendor supplies or delivery mechanisms. This will need to be considered in relation to the number of tests anticipated in both critical care and general care patient populations (https://covidprotocols.org) and the likelihood of filling COVID-19 expansion beds as part of surge planning ( Fig. 2). The lab should prepare for an increased number of mechanically ventilated patients. Hospital leadership can provide details about the plans to expand patient care areas for COVID-19 patients and the expected testing volumes. It may also be valuable to preemptively evaluate the potential benefit of increased point-of-care testing to ease the burden of samples sent to the laboratory. However, it is essential to consider the entire workflow, including interface work that may be required for new tests.

Example contingency planning FTE assignment tool. Using the Chemistry section as an example, a similar contingency planning tool can be used across core clinical lab specialties to assess benches/testing that can be performed depending upon available staffing. Its design affords managers to use this tool daily to assign benches, considering priority of assays and specimen stability for assays that are batched. Notably, increased risks of staffing concerns are seen on off-shifts (weekend days, evenings, and nights) and may be addressed by identifying staff who would volunteer to be on-call to cover these shifts as needed. A similar tool can be used to automate communication within the department and help reallocate staffing where it is needed, while also providing updates to clinical care teams. Data for the Chemistry section are offered as an example of information to collect, which is dependent on testing volumes, breadth of testing offered, as well other lab-specific needs. Lab Control/Receiving, Hematology, and Lab Management sections are provided as a place holder, with blank, shaded cells indicating additional data to be entered. A downloadable Excel file of this table is available as Supplemental Table 1 . FTE: baseline full-time equivalent (FTE) staff number; DS: preemptive down-staffing to create alternating labor pools; Min: minimum number of FTE required to support only emergent testing; %Min: minimum percentage of full staffing capacity to perform testing; Float: no dedicated staff, staff from other benches to cover as able; d/c: discard and cancel; 1+: requires supervisor review and sign-off.

670 general care and 280 intensive care unit (ICU) beds, the anticipated volume of laboratory testing during an anticipated surge can be estimated following testing protocols outlined by the institution (e.g., https://covidprotocols.org/protocols/02-ed-inpatient-floor-management-triage-transfers). A downloadable Excel file of this table is available as Supplemental Table 2. GC, general care unit; ICU, intensive/critical care unit; SCT, stem sell transplant; ABG/VBG, arterial/venous blood gas; CK, creatinine kinase; LFT, liver function tests; LDH, lactate dehydrogenase; CRP, C-reactive peptide; PT/INR, prothrombin time/international normalized ratio; +, additional testing expected, unpredictable volumes." />

Sample surge planning tool for emergent laboratory testing. Using a surge planning model of 670 general care and 280 intensive care unit (ICU) beds, the anticipated volume of laboratory testing during an anticipated surge can be estimated following testing protocols outlined by the institution (e.g., https://covidprotocols.org/protocols/02-ed-inpatient-floor-management-triage-transfers). A downloadable Excel file of this table is available as Supplemental Table 2 . GC, general care unit; ICU, intensive/critical care unit; SCT, stem sell transplant; ABG/VBG, arterial/venous blood gas; CK, creatinine kinase; LFT, liver function tests; LDH, lactate dehydrogenase; CRP, C-reactive peptide; PT/INR, prothrombin time/international normalized ratio; +, additional testing expected, unpredictable volumes.

As elective surgical procedures are postponed, staff across the department may be available to provide support and back-up to the essential functions of the lab, particularly on off-shifts. Cross-training amongst the various core laboratory areas, ideally in advance of significant absenteeism, will yield flexibility of assignments. As universities are increasingly scaling back research operations, other able-bodied personnel such as research scientists, medical students, or Pathology residents may help the clinical laboratory as long as institutional policies and regulatory requirements are met. Noncertified personnel may assist the laboratory with, for example, internal specimen courier services, specimen accessioning, inventory, or the assembly of COVID-19 test collection kits.

Finally, open and continuous communication, both among the laboratory department and healthcare providers, should be maintained with regards to the status of laboratory services. Electronic ‘daily huddles’ can help with assessing the number of staff available, the benches that will operate each day, and where additional staff can be relocated to support intradepartmental needs. Daily assessment and communication can be automated via e-mail templates to inform the hospital of real-time lab staffing capacity and tests that will be unavailable or delayed.

In summary, there are a number of steps the laboratory can preemptively take as part of disaster planning that involve cross-specialty collaboration within laboratory medicine and with the support of hospital leadership ( Table 1).

Strategies for contingency planning in the clinical laboratory amidst the COVID-19 pandemic.

Strategies for contingency planning in the clinical laboratory amidst the COVID-19 pandemic.

Supplemental Material

Supplemental material is available at The Journal of Applied Laboratory Medicine online.

Nonstandard Abbreviations

COVID-19, coronavirus disease 2019; SARS-CoV-2, novel severe acute respiratory syndrome coronavirus 2; FTE, full-time equivalent.

Author Contributions

All authors confirmed they have contributed to the intellectual content of this paper and have met the following 4 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; (c) final approval of the published article; and (d) agreement to be accountable for all aspects of the article thus ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved.

Authors’ Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest: Employment or Leadership: A.B. Chambliss, The Journal of Applied Laboratory Medicine, AACC; N.V. Tolan, The Journal of Applied Laboratory Medicine, AACC. Consultant or Advisory Role: None declared. Stock Ownership: None declared. Honoraria: None declared. Research Funding: None declared. Expert Testimony: None declared. Patents: None declared.