Journal:Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center

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Full article title Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center
Journal Journal of the American Medical Informatics Association
Author(s) Weemaes, Matthias; Martens, Steven; Cuypers, Lize; Van Elslande, Jan; Hoet, Katrien; Welkenhuysen, Joris; Goossens, Ria; Wouters, Stijn;
Houben, Els; Jeuris, Kirsten; Laenen, Lies; Bruyninckx, Katrien; Beuselinck, Kurt; André, Emmanuel; Depypere, Melissa; Desmet, Stefanie;
Lagrou, Katrien; Van Ranst, Marc; Verdonck, Ann K.L.C.; Goveia, Jermaine
Author affiliation(s) University Hospitals Leuven, Katholieke Universiteit Leuven
Primary contact Email: jermaine dot goveia at uzleuven dot be
Year published 2020
Volume and issue Ahead of print
Article # ocaa081
DOI 10.1093/jamia/ocaa081
ISSN 1527-974X
Distribution license Creative Commons Attribution Non-Commercial 4.0 International
Website https://academic.oup.com/jamia/advance-article/doi/10.1093/jamia/ocaa081/5827002
Download https://academic.oup.com/jamia/advance-article-pdf/doi/10.1093/jamia/ocaa081/33421026/ocaa081.pdf (PDF)

Abstract

Objective: The study sought to describe the development, implementation, and requirements of laboratory information system (LIS) functionality to manage test ordering, registration, specimen flow, and result reporting during the coronavirus disease 2019 (COVID-19) pandemic.

Materials and methods: Our large (more than 12,000,000 tests/year) academic hospital laboratory is the Belgian National Reference Center for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. We have performed a moving total of more than 25,000 SARS-CoV-2 polymerase chain reaction tests in parallel to standard routine testing since the start of the outbreak. A LIS implementation team dedicated to developing tools to remove workflow bottlenecks—primarily situated in the pre- and post-analytical phases—was established early in the crisis.

Results: We outline the design, implementation, and requirements of LIS functionality related to managing increased test demand during the COVID-19 crisis, including tools for test ordering, standardized order sets integrated into a computerized physician order entry module, notifications on shipping requirements, automated triaging based on digital metadata forms, and the establishment of databases with contact details of other laboratories and primary care physicians to enable automated reporting. We also describe our approach to data mining and reporting of actionable daily summary statistics to governing bodies and other policymakers.

Conclusions: Rapidly developed, agile extendable LIS functionality and its meaningful use alleviates the administrative burden on laboratory personnel and improves turnaround time of SARS-CoV-2 testing. It will be important to maintain an environment that is conducive for the rapid adoption of meaningful LIS tools after the COVID-19 crisis.

Keywords: COVID-19, laboratory information system, health information technology implementation, computerized provider order entry, change management

Introduction

Background and significance

The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus has caused a pandemic with unprecedented medical and socioeconomic adversity. Second- and third-wave outbreaks are becoming a reality in several countries, at least partially, due to low herd immunity.[1] Laboratory testing to rapidly detect SARS-CoV-2 using polymerase chain reaction (PCR) is essential to guide proper patient management[2], while serological assays will soon be required to assess population immunity (e.g., antibody tests) and guide national coronavirus disease 2019 (COVID-19) pandemic policies.[1]

The increased demand for round-the-clock laboratory testing during the COVID-19 pandemic has surpassed surge capacity in many clinical laboratories, resulting in significant strain on laboratory personnel and infrastructure.[3][4] These developments are especially undesirable when laboratories already have to process a large numbers of potentially biohazardous specimens every day. Additional delays in testing directly translate into delayed clinical decision making and consequently congest emergency departments and isolation units.[3] Therefore, leveraging the capabilities of laboratory information systems (LIS) to streamline all phases of laboratory testing workflow (preanalytical, analytical, and postanalytical) has proven essential.

To our knowledge, only a single report has been published that discusses the implementation of health informatics to support clinical management of the COVID-19 pandemic through novel electronic health record (EHR) functionality.[5] COVID-19 is a laboratory diagnosis with immediate consequences in the health sector (hospitalization, patient isolation, postponing surgery, etc.). Therefore, clinical laboratories face specific challenges that require dedicated LIS functionality to ensure safe, reliable testing and acceptable turnaround times.[3] However, no literature exists on tools that leverage the LIS in order to alleviate the burden on laboratory personnel, streamline laboratory testing, improve test reporting, facilitate epidemiological and translational research, and enable data-driven policy making.

Objectives

Here, we describe the challenges faced by the Belgian National Reference Center for COVID-19 testing when demand passed allocated surge capacity during the initial phases of the COVID-19 pandemic. We used Kotter’s principles as a framework to rapidly develop and implement additional LIS functionality (Table 1).[6] We implemented tools to manage specimen and data streams, and detail functionality to improve (1) the prelaboratory phase (test ordering, specimen packaging, and shipping), (2) the preanalytical phase (specimen registration, tracking, and test prioritization [triaging]), and (3) the postanalytical phase (automated reporting and facilitating data-driven policymaking). We also briefly discuss unexpected opportunities in which the COVID-19 crisis accelerated the adoption of practices that promote the meaningful use of LIS systems.


Table 1. Kotter’s principles[6] applied to laboratory informatics change management during the COVID-19 crisis
Kotter’s principles Change management in response to the COVID-19 crisis
Phase 1. Creating a climate for change
Step 1. Establing a sense of urgency
▪ Comfortability with the known and fearfulness of the unknown hampers innovation.
▪ Convey why the change is needed and why does it need to occur now.
▪ The COVID-19 pandemic put a tremendous burden on the medical administration staff.
▪ Manual registration of order forms into the LIS system from external laboratories was highly labor intensive.
▪ Sample reception, triage, and patient registration at the laboratory were overwhelming.
▪ Only one-third of results is automatically reported.
▪ Together, these issues clearly conveyed the necessity to implement IT tools.
Step 2. Building a powerful guiding coalition
▪ Identify key staff members.
▪ Attract eager, people-oriented, and real leaders.
▪ Establish a crisis management team (CMT).
▪ The CMT should consist of a goal-oriented group of expert staff.
▪ Include IT managers in CMT, as well as analytical and human resource personnel.
Step 3. Creating a clear vision
▪ Define what the future state should look like.
▪ Capitalize on pre-existing and newly developed health IT platforms to:
   ▪ decrease the burden on clinical, administrative, and scientific staff;
   ▪ reallocate technical staff to the tasks related to the analytical phase; and
   ▪ support COVID-19 crisis management.
▪ Focus on innovation and scientific advances.
Phase 2. Communication and empowering others
Step 4. Communicating the proposed vision
▪ Communicate how this change will affect everyone.
▪ Provide much-needed emotional support.
 
Step 5. Empowering others to act on the vision
▪ Delegate leadership roles (workflow redesign).
▪ Schedule weekly meetings to brief staff on:
   ▪ emerging problems and bottlenecks; and
   ▪ proposed solutions and expected benefits.
▪ Invite staff to propose alternative and additional solutions, and include IT professionals in their discussion.
▪ Delegate responsibilities to staff beyond the CMT to proactively solve problems in-line with the vision, including:
   ▪ IT professionals;
   ▪ lab technicians; and
   ▪ clinical pathology residents.
Step 6. Planning and creating short-term gains
▪ Promote good ideas.
▪ Celebrate successes as often as possible.
▪ Communicate success regarding the following achievements:
   ▪ improved efficiency in ordering COVID-19 laboratory testing;
   ▪ reduction in workload (improved work schedules);
   ▪ automatic reporting of >98% of analytical results;
   ▪ reduction in the number of phone calls to the COVID-19 call center;
   ▪ implementation of a lean and easily adaptable database for fully automated reporting; and
   ▪ automatic summary statistics reporting, with attractive data visualizations to all stakeholders.
Phase 3. Implementation and sustaining the changes
Step 7. Consolidating improvements
▪ Continue problem solving and promoting solutions.
▪ The successful implementation of COVID-19 solutions results in a gain in workflow efficiency, and …
Step 8. Institutionalizing new approaches
▪ Focus on changing interpersonal work dynamics to organizational culture.
▪ … a reduction in the administrative burden causes increased engagement of all laboratory staff to remedy
problems through novel IT solutions.

Materials and methods

The University Hospitals Leuven is a 2000-bed hospital providing nationwide services via approximately 700,000 consultations, 55,000 admissions, 60,000 emergencies, and 55,000 surgeries annually. The hospital uses a fully in-house–developed EHR that is also commercially available[7] and used in approximately 50% of hospitals in the Flemish Region of Belgium. The clinical laboratory department annually performs around 12,000,000 tests and has national reference functions for several infectious diseases, including the respiratory disease COVID-19. The laboratory performed a total of >25,000 SARS-CoV-2 PCR tests on respiratory samples between February 1 and April 20, 2020. Samples were sent to the reference laboratory from across Belgium, and once analyzed, results were reported to referring clinical laboratories as well as to hospitals and primary care physicians. The LIS is developed in-house and maintained by a dedicated team of computer science engineers and implementation staff. Our LIS includes a computerized physician order entry (CPOE) module for in-house test ordering, which is fully integrated into the EHR.

The LIS automatically sends all validated results to a national EHR database that is directly connected to patient-accessible web-based and mobile applications. All external orders, including those for reference testing, are paper-based and require that request forms accompany the sample. LIS development is directed by a clinical pathologist, allowing for rapid signaling of practical bottlenecks and guidance on the development of health information technology (IT) tools.

Results

COVID-19–specific challenges to laboratory management

During the early stages of the COVID-19 outbreak, our laboratory was the only SARS-CoV-2 testing center in Belgium. The first case of COVID-19 in Belgium was confirmed by our laboratory on February 3, 2020. The following month, SARS-CoV-2 PCR testing grew exponentially to >750 tests per day, at which point both traditional analytical infrastructure and reagents became limiting factors (Figure 1). To manage the acute crisis, we established a crisis management team (CMT) consisting of clinical pathology staff specialized in microbiology and in LIS development. The CMT readily implemented a test prioritization (triage) system to reduce stress on reagents and addressed key bottlenecks in the preanalytical and postanalytical phase. Maximum upscaling in terms of full-time equivalents (FTEs) was estimated to be an additional 20 FTEs for the preanalytical phase, five for the analytical phase, and 13 for the postanalytical phase (Figure 2). These FTEs were divided among three different shifts. After stabilization of the sample flow, a fraction of laboratory staff was reallocated to perform test validation, leaving some scientific staff to be reallocated to epidemiological studies.


Fig1 Weemaes JAMIA2020 ocaa081.png

Figure 1. Evolution of coronavirus disease 2019 (COVID-19) laboratory testing and triage criteria. The number of severe acute respiratory syndrome coronavirus 2 polymerase chain reaction (PCR) tests (y-axis) per day (x-axis) from February 19 to April 20, 2020. Gray bars indicate the number of samples with a negative PCR result, yellow bars indicate positive PCR results. Triangles on the x-axis indicate key decisions made by the crisis management team that affected sample triaging or processing. Samples analyzed before February 19 were not registered in the laboratory information system.

Fig2 Weemaes JAMIA2020 ocaa081.png

Figure 2. Graphical representation of key bottlenecks in coronavirus disease 2019 (COVID-19) sample flow. Gray boxes represent different stages in the laboratory analysis of COVID-19 samples. Stages have been group as preanalytical, analytical, and postanalytical phases. The box demarcated with a dotted line was newly implemented during the COVID-19 period. Maroon icons represent staff allocation before the COVID-19 pandemic, blue icons represent staff allocation during the COVID-19 pandemic (1 icon corresponds to 1 full-time equivalent [FTE]). Note, 30 of 38 additional pandemic-associated FTEs were assigned to administrative preanalytical– and postanalytical–related tasks. PCR: polymerase chain reaction.

Notably, the large majority of our expanded workforce (30 of the 38 additional FTEs) was assigned to help with administrative tasks (sample reception, triaging, patient registration, result validation and reporting, and epidemiological studies), and was not directly involved in expanding analytical capacity (i.e., PCR analysis) (Figure 2). By April 2020, reagent supply and machine capacity were more adequate (Figure 1), but pre- and postanalytical bottlenecks could only be resolved by the implementation of dedicated perianalytical IT solutions that reduced administrative burden on laboratory staff by streamlining data flows (Table 2).


Table 2.Laboratory challenges and IT solutions during the COVID-19 crisis
Challenge LIS solution Advantage over paper-based methods
Prelaboratory phase
Standardized order forms Computerized order entry Quickly adaptable
Standardized ordering COVID-19 order sets Quickly adaptable and uniform test ordering
Emergency laboratory order COVID-19 as emergency laboratory test Alleviates burden on medical staff in COVID-19 departments during busy shifts
Sample collection and shipping instructions Digital notifications Improve sample collection and shipping to reduce biohazards
Preanalytical phase
Sample registration Computerized order entry Alleviates burden on medical administration staff
Test prioritization (triaging) Automated scripted triaging Quickly adaptable and uniform triaging, alleviates burden on medical administration staff
Sample tracking: storage Sample tracking Easily retrieve samples for rapid testing, select samples for scientific studies
Real-time sample tracking Sample tracking Estimate individualized turnaround time
Analytical phase
LIS interface Bidirectional interfacing Alleviates burden on laboratory technicians
Postanalytical phase
Automated validation Statistical flagging of outliers Alleviates burden on clinical chemists
Automated reporting Automated fax, encrypted email Alleviates burden on medical administration staff
Reporting intermediary or invalid results Automated fax, encrypted email Alleviates burden on medical administration staff and call center
Postlaboratory phase
Epidemiological reporting Automated email and text messages Alleviates burden on medical administration staff
Communication Searchable database Easily retrieve detailed information of each sample
Epidemiological studies Sample tracking Select samples for scientific studies
Crisis management Daily summary statistics Data-driven adjustment to triaging
Index patient tracking Computerized order entry Complete digital order forms that include all necessary information for index patient tracking

References

  1. 1.0 1.1 Hellewell, J.; Abbott, S.; Gimma, A. et al. (2020). "Feasibility of controlling COVID-19 outbreaks by isolation of cases and contacts". Lancet Global Health 8 (4): e488-e496. doi:10.1016/S2214-109X(20)30074-7. PMC PMC7097845. PMID 32119825. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7097845. 
  2. Guan, W.-J.; Ni, Z.-Y.; Hu, Y. et al. (2020). "Clinical Characteristics of Coronavirus Disease 2019 in China". New England Journal of Medicine 382 (18): 1708–20. doi:10.1056/NEJMoa2002032. PMC PMC7092819. PMID 32109013. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092819. 
  3. 3.0 3.1 3.2 Lippi, G.; Plebani, M. (2020). "The critical role of laboratory medicine during coronavirus disease 2019 (COVID-19) and other viral outbreaks". Clinical Chemistry and Laboratory Medicine 58 (7): 1063–69. doi:10.1515/cclm-2020-0240. PMID 32191623. 
  4. Posteraro, B.; Marchetti, S.; Roman, L. et al. (2020). "Clinical microbiology laboratory adaptation to COVID-19 emergency: Experience at a large teaching hospital in Rome, Italy". Clinical Microbiology and Infection 26 (8): 1109-1111. doi:10.1016/j.cmi.2020.04.016. PMC 32330569. PMID 32330569. https://www.ncbi.nlm.nih.gov/pmc/articles/32330569. 
  5. Reeves, J.J.; Hollandsworth, H.M.; Torriani, F.J. et al. (2020). "Rapid response to COVID-19: Health informatics support for outbreak management in an academic health system". Journal of the American Medical Informatics Association 27 (6): 853-859. doi:10.1093/jamia/ocaa037. PMC PMC7184393. PMID 32208481. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7184393. 
  6. 6.0 6.1 Kotter, J.P. (May–June 1995). "Leading Change: Why Transformation Efforts Fail". Harvard Business Review. https://hbr.org/1995/05/leading-change-why-transformation-efforts-fail-2. Retrieved 22 April 2020. 
  7. "NexuzHealth". Nexuzhealth. https://www.nexuzhealth.be/en. Retrieved 22 April 2020. 

Notes

This presentation is faithful to the original, with only a few minor changes to presentation. In some cases important information was missing from the references, and that information was added.