The relatively recent appearance of coronavirus disease 2019 (COVID-19), a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is now challenging response and resilience of healthcare systems all around the globe . The upgrade of this outbreak to a pandemic by the World Health Organization (WHO)  highlights the serious nature of the disease, which has caused unexpected and unprecedented disruption and challenges to laboratory practices , . In particular, the highly infectious nature of this novel coronavirus and the risk of progression toward severe, even critical, forms of disease have necessitated measures to limit the risk of nosocomial transmission in clinical laboratories which routinely handle large volumes of specimens from suspected and confirmed COVID-19 cases , . Considering the infectiousness and severity of COVID-19, the epidemic will affect laboratories around the world, and there is a need to understand how they are managing the operational challenges.
The Task Force on COVID-19, recently established under the umbrella of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) (https://www.ifcc.org/executive-board-and-council/eb-task-forces/ifcc-task-force-on-covid-19/), has prepared and undertaken a global survey aimed at elucidating how clinical laboratories manage operational challenges during the COVID-19 outbreak. This article describes the second part of data garnered with this survey. The first part of the survey data is published in a separate companion article .
Materials and methods
A survey questionnaire has been conceived and then constructed by three chemical pathologists from Singapore and Australia (see Supplementary material). After a concise presentation aimed at describing the purposes of the survey, an informed consent was asked to survey participants for publicizing the information. This survey has been conducted without requesting identifiable data from responders. Participants were then asked to answer specific questions dealing with some characteristics of their laboratory, as well as with pre-analytical, analytical, post-analytical and operational activities. The original draft of the survey has been pilot tested in seven laboratories in Sydney (Australia) and Singapore, undergoing two refinement cycles.
The questionnaire was then constructed using an enterprise internet survey engine (Verint Systems, Melville, NY, USA), being published in the English language on April 16, 2020. Chinese, Spanish and French translations of the survey were also developed and disseminated on April 22, 2020. The survey was publicized globally through multiple channels, including the IFCC eNewsFlash, the Canadian Society for Clinical Chemistry, the Australasian Association for Clinical Biochemistry and Laboratory Medicine, the European Federation of Clinical Chemistry and Laboratory Medicine, the American Association for Clinical Chemistry, the Spanish Society of Laboratory Medicine, the Korean Society for Clinical Chemistry, the Chinese Society of Laboratory Medicine, the Argentinian National Society and the Latin American Confederation of Clinical Biochemistry. The survey was closed on May 1, 2020.
All responses were retrieved from the survey engine into an Excel file and analyzed using Analyse-It (for Microsoft Excel, Microsoft, Seattle, WA, USA). This study focused on survey responses related to operational considerations and challenges, which were hence summarized only using descriptive statistics.
General characteristics of survey participants
The survey received 1483 valid submissions. A total number of 273 of these submissions ought to be excluded because the responders replied that they were not involved in processing biospecimens from COVID-19 patients at the time of the survey, or failed to reply to this question. Overall, the final analysis was hence based on 1210 valid submissions, 921 in English, 62 in Chinese, 183 in Spanish and 44 in French, respectively, from 86 worldwide regions and countries (Supplementary Table 1). The general aspects of responders are briefly reported in Table 1. Most participants declared to be working in hospital laboratories and more than half declared to be managing between 200 and 2500 biospecimens per day. Nearly half of all clinical laboratories were using partial or total laboratory automation. The responses to operational considerations and challenges during the COVID-19 pandemic are summarized in Figure 1.
General characteristics of survey participants.
|Question||Response||Frequency, n (% of total submission)|
|Which of the following best describes your biochemistry laboratory?||Hospital central/core laboratory||998 (82.4)|
|Hospital satellite laboratory||69 (5.7)|
|Community-based laboratory||81 (6.7)|
|Which of the following patient populations are served by your biochemistry laboratory? Please select all that apply||Inpatient||1101 (90.1)|
|Emergency department||1023 (84.5)|
|Intensive care units||1007 (83.2)|
|Not answered||4 (0.3)|
|Please indicate the number of patient samples your laboratory processes per day?||<200 samples||301 (24.9)|
|200–999 samples||446 (36.9)|
|1000–2500 samples||253 (20.9)|
|>2500 samples||204 (16.9)|
|Not answered||6 (0.5)|
|Does the biochemistry laboratory use any of the following components of a laboratory automation system? Please select all that apply||Centrifugation||752 (20.3)|
|Sample storage||593 (49.0)|
|Sample conveyance track||466 (38.5)|
|We do not use a laboratory automation system||373 (30.8)|
|Not answered||12 (1.0)|
Test restriction due to biosafety concerns
More than three quarters of the clinical laboratories did not limit test availability for COVID-19 patients due to biosafety concerns. Around 15% of laboratories restricted certain tests on patients with clinically suspected or confirmed COVID-19 over biosafety concerns. The most common restrictions were testing on pleural fluid and respiratory samples, followed by fecal tests, urine tests and direct microscopy (Table 2).
List of limited tests and/or samples due to biosafety concerns during the COVID-19 pandemic.
|Tests||Frequency, n (% of total submission)|
|Pleural fluid, respiratory sample tests||50 (4.1)|
|Fecal test||46 (3.8)|
|Urine tests||18 (1.5)|
|Direct microscopy||18 (1.5)|
|Tests that are not part of predefined ‘basic biochemistry’||13 (1.1)|
|Body fluid tests||8 (0.7)|
|Non-automation/manual tests||7 (0.6)|
|Salivary cortisol||4 (0.3)|
Test restriction due to resource limitations
Nearly 90% of participating laboratories did not limit their test menus due to resource limitations. Nevertheless, 12 laboratories (1.0%) reported a reduction in testing volume that necessitated test suspension, whilst four laboratories (0.3%) declared that they will be considering to restrict the test menu in case they may face a shortage of staff. Just over 10% of laboratories had to restrict their test menu or services for resource constraints. The 20 most common tests and services suspended due to resource constraints are summarized in Table 3. Among the resource constraints cited alongside the tests and service suspension include shortage of reagent (n=5; 0.4%), lack of biosafety cabinet (n=5; 0.4%), lack of personal protective equipment (PPE) (n=4; 0.3%) and shortage of internal quality control materials (n=2; 0.2%).
Top 20 tests and laboratory services suspended due to resource constraints during the COVID-19 pandemic.
|Test name||Frequency, n (% of total submission)|
|Fecal tests||23 (1.9)|
|Pleural fluid tests||12 (1)|
|‘Non-emergency tests’||7 (0.6)|
|Fertility hormones (including androgen testing)||5 (0.4)|
|‘Specialized biochemistry’ tests||5 (0.4)|
|Urine tests||4 (0.3)|
|Vitamin testing||4 (0.3)|
|General endocrinology tests||4 (0.3)|
|Protein and urine electrophoresis||3 (0.2)|
|Sweat test||3 (0.2)|
|Urea breath test||3 (0.2)|
|Salivary cortisol||2 (0.2)|
|Allergy testing||2 (0.2)|
|Adrenal hormone testing (urine)||2 (0.2)|
|Suspension/restriction of outpatient testing||9 (0.7)|
|Suspension/restriction of referred-in testing||6 (0.5)|
|Prolonged turnaround time, reduced frequency||6 (0.5)|
|Restriction of phlebotomy services||4 (0.3)|
|Manual dilution, pipetting||3 (0.2)|
Monitoring of health status of laboratory personnel and disinfection practices
Temperature monitoring of the staff was established in 37.4% of laboratories, most of which with once-a-day monitoring (Figure 1). Most laboratories concurrently increased the frequency of disinfection from a median value of once per day (interquartile range: 1–2 times/day) to 4 times per day (interquartile range: 3–6 times/day). Some laboratories disinfected the laboratory every 30 min or after handling COVID-19 patient samples. In laboratories that changed the disinfecting agent, most adopted 70% alcohol or bleach-based solutions, with varying concentrations (i.e. between 0.1% and 10%). Other disinfecting agents adopted were Virusol, Clinell wipes, Virkon, Stericid, Incidin, Oxy wipes, quaternary ammonium and ultraviolet light. The cleaning practices also extended beyond workbenches to all laboratory areas and surfaces. These also included administrative and staff rooms. Additionally, high touch point surfaces such as door handles, switches, computer and peripherals, phones, refrigerators, shelves, containers, and floors were cleaned more often and thoroughly.
Approximately half of responding laboratories reported to have split their staff into separate teams. Most often, the staff was split into two teams, working in single shift (i.e. the teams do not work together in consecutive days). Most laboratories that split the staff into teams did so for all the staff, followed by technologists and clinical staff (Figure 1).
Personnel designing the operational processes
In most laboratories, laboratory managers, laboratory clinicians and laboratory scientists as well as technologists were responsible for designing the operational processes during the COVID-19 pandemic. Hospital infection control teams and hospital administrations were involved in a quarter of cases. The clinical, scientific and technical staff with biochemistry background were most often involved in designing the operational processes for their laboratory, often with input from their microbiology colleagues (Table 4).
Top eight clinical specialties responsible for designing the operational processes for clinical laboratories in managing the workload during the COVID-19 pandemic.
|Laboratory clinicians/ pathologists||Frequency, n (% of total submission)|
|Laboratory medicine/clinical pathology||25 (2.1)|
|Multi-disciplinary (unspecified)||10 (0.8)|
|Pathology (unspecified)||8 (0.7)|
|Laboratory medicine||5 (0.4)|
|Multi-disciplinary (unspecified)||5 (0.4)|
Self-reported operational challenges in clinical laboratory
In this final section of the survey, the participants were asked “What was the biggest operational challenge your laboratory had to face during the COVID-19 epidemic?” The greatest reported challenge that clinical laboratories faced during the COVID-19 pandemic was represented by securing sufficient supplies of PPE, analytical equipment, including point-of-care testing, as well as reagents, consumables and other laboratory materials (Table 5). These supply chain issues were followed by inadequate staff availability, management of morale, anxiety and deployment. Ensuring safety within the laboratory was an ongoing challenge. Reported operational challenges included managing the change in test demands and in operational processes, as well as needing to set up new diagnostic tests within a very short time. Reported managerial challenges included the lack of appropriate experience in disaster or crisis management, knowledge and leadership in senior management, and maintaining good communications.
Operational challenges faced during the COVID-19 pandemic.
|Challenges||Frequency, n (%)|
|Supplies and testing resources|
|Personal protective equipment (availability)||104 (8.6)|
|Difficulty obtaining equipment, reagents, consumables, materials||64 (5.3)|
|Lack of biosafety cabinet||14 (1.2)|
|Insufficient laboratory space||7 (0.6)|
|Inadequate equipment, aged equipment, non-automated equipment||5 (0.4)|
|Inadequate staffing||64 (5.3)|
|Maintaining staff morale, managing staff anxiety||50 (4.1)|
|Organizing staff roster, redeployment of staff, recruitment of new staff||34 (2.8)|
|Organizing and working in split teams, teleworking||33 (2.7)|
|Staff training||3 (0.2)|
|Ensuring safe working condition/environment||57 (4.7)|
|Handling of patient samples safety||36 (3.0)|
|Enforcing increased/new disinfection, biosafety processes||34 (2.8)|
|Maintaining social distancing, minimizing interaction||25 (2.1)|
|Biosafety assessment of various laboratory practices and processes||21 (1.7)|
|Personal protective equipment (using them)||11 (0.9)|
|Direct identification of samples from patients with COVID-19||10 (0.8)|
|Personal protective equipment, waste disposal||4 (0.3)|
|Separating clean and contaminated areas||3 (0.2)|
|Managing change in testing demand (increase/decrease)||47 (3.9)|
|Managing operational process change||29 (2.4)|
|Setting up and verification of new assays at short notice||27 (2.2)|
|Organization of additional analyzers (e.g. blood gas, POCT)||14 (1.2)|
|Managing and reorganizing sample collection processes/services||18 (1.5)|
|Managing sample transport to laboratory||17 (1.4)|
|Maintaining service level at increased biosafety practice||17 (1.4)|
|Enforcing new laboratory protocol||11 (0.9)|
|Transport of staff, technician, maintenance, servicing during lockdown||10 (0.8)|
|Reorganization of physical laboratory space||7 (0.6)|
|Supporting opening of new healthcare facility||7 (0.6)|
|Lack of experience, knowledge, leadership in senior staff/management||21 (1.7)|
|Communication and coordination within and between teams||20 (1.7)|
|Frequent change in and reconciling differences in guidelines||13 (1.1)|
|Economic loss||8 (0.7)|
|Lack of reliable information||7 (0.6)|
During the COVID-19 pandemic, clinical laboratories were confronted by two major challenges, encompassing the need to ensure a safe workplace environment and maintaining laboratory activities often without adequate resources. In response to these challenges, some facilities were forced to limit laboratory test availability. The analyses that were restricted for biohazard concerns mostly involved pleural fluid, respiratory samples, and fecal and urine specimens. This choice may be related to reports of viral nucleic acid being detected in fecal and urine samples , , , , but the latter is particularly surprising considering its extremely low positivity rate in COVID-19 patients , . However, the transmissibility of SARS-CoV-2 in these biospecimens remains uncertain , . Similarly, laboratory tests that require manual manipulation or are not testable with automated instruments have been limited. The IFCC Task Force on COVID-19 currently recommends management of these samples in a biosafety cabinet, whenever the risk of aerosolization is high . However, this equipment may be unavailable in many routine laboratories, which may hence expose the laboratory staff to a significant biohazard risk when handling high-risk clinical samples such as pleural fluid.
Resource constraints imposed by COVID-19 have also compelled many clinical laboratories to limit their test menu availability. Although most of the restricted tests also carry biosafety risks (e.g. fecal and urine analyses), others such as endocrine testing, specialized biochemistry testing, as well as services such as outpatient testing and referred-in testing may have impact beyond the care of patients with COVID-19. Prolonged turnaround times may also have an impact. When such tests or services cannot be performed within the laboratory, sample referral to external facilities may be considered, if clinically indicated. However, selection of external laboratories is more challenging during pandemics, as there is shortage of time for addressing the performance of such laboratories or for assessing test result comparability. This lack of validating external laboratories is particularly problematic when patients are regularly monitored by tests that are poorly harmonized, which calls for better preparation of contingency plans for esoteric or specialized testing services.
Beyond the use of PPE, additional operational biosafety precautions can be adopted within the laboratory environment. These include daily temperature monitoring of the staff, which our survey showed many laboratories were unable to perform. This inability may increase the risk of cluster outbreaks from personnel with asymptomatic or undetected COVID-19. This risk is particularly high in regions with high rates of community transmission. However, it is important to remember that temperature monitoring does not guarantee the detection of all potentially infected patients, due to the rate of transmissions occurring during the pre-symptomatic incubation period or due to possible cases of asymptomatic infections , . Other biosafety measures, not directly related to the risk posed by the possible transmission from processed samples, should be respected including social distancing, facemask wearing and correct hand hygiene.
Another operational biosafety precaution entails reinforced disinfection practices within the laboratory. In this regard, most laboratories reported an increased frequency of disinfection, with most of them cleaning 3 times or more per day. It is important to adhere to recommended disinfection agents and frequency (at least once every 3 h) to minimize the risk of work bench contamination . About a quarter of laboratories also reported an increase in areas cleaned, which often included high touchpoint areas and ‘non-clinical’ areas, such as administrative and rest rooms.
To reduce the potential risk and proportion of staff being exposed to a colleague with asymptomatic or undetected COVID-19, approximately half of all laboratories split their teams. This allows the staff to isolate at most the members of the same team as the index staff, while preserving the functioning of the alternate team. Indeed, several laboratories shared the challenges in managing the laboratory owing to significant number of staff requiring self-isolation/quarantine after direct exposure to a colleague who was diagnosed as having COVID-19.
Most often, laboratory staff is split into two teams. The implementation of split teams can be highly challenging without adequate staffing level, and may need longer working hours to ensure sufficient service coverage. The different teams should not meet or work in overlapping shifts to minimize contact. This can pose a challenge to communications, handover and continuity of services. A longer stretch of duration of work of each team is probably desirable to further minimize interaction between teams. It may also be easier to plan the roster of such arrangements. The most effective split team arrangement involves all staff. Often-overlooked personnel in split team arrangement is the cleaning staff, who often interacts with multiple areas of the laboratory.
The operational processes in the laboratory are most commonly planned by clinicians, scientists/technologists and laboratory managers. The clinical specialties involved in such planning are biochemistry, microbiology and hospital infection control teams. Inclusion of microbiology and hospital infection control colleagues can be helpful in performing biosafety assessment. Administrative support is often required for vital optimal operations, whilst involvement of hospital administration can help mobilizing resources and provide political buy-in for decisions that may impact wide-ranging stakeholders (e.g. restriction of tests or services).
Finally, the number of challenges facing the laboratory profession during COVID-19 is vast. Foremost amongst these is the lack of testing resources and availability of consumables. Staff rostering and biosafety concerns require longer-term solutions, as they are crucial for continued operation of laboratory during what may well be a prolonged pandemic. Operational challenges require problem-solving and organizational skills in a flexible environment. Adding to the challenge is often the wider imposed public health measures, such as community lockdown for reinforcing social distancing (e.g. public transport limitations), which may have unintended consequences on critical sectors such as healthcare, national security or food delivery. For example, this has resulted in challenges in transporting staff to work, receiving supplies, and convincing vendors to provide repair and servicing to laboratory instruments.
The pandemic has affected the routine work of the clinical laboratory and has manifested in the form of test restriction. The restriction of tests and services may have undesirable clinical consequences, as clinicians are deprived of important laboratory data and information for delivering appropriate care to their patients. Temperature monitoring and splitting staff into teams can reduce the risk of transmission within the laboratory environment but is not practiced widely by the survey participants. The latter is difficult to implement without adequate staffing capacity. A multi-disciplinary approach in planning laboratory operations during times of uncertainty is likely to result in better well-thought-out decisions. The greatest reported challenge faced by laboratories is the lack of testing resources and consumables. The laboratory is an indispensable pillar of clinical care during the COVID-19 pandemic and the profession has risen to the task despite seemingly insurmountable challenges.
We are grateful to Silvia Colli-Lanzi and Paola Bramati in the IFCC Office in Milan, Kevin Carpenter (Australasian Association for Clinical Biochemistry and Laboratory Medicine), Ana-Maria Simundic (Clinical Chemistry and Laboratory Medicine), Max Reed (New Zealand), Soo-Youn Lee (Korean Society for Clinical Chemistry), Eric Kilpatrick, Chung Shun Ho and Jeffrey Kwok (Hong Kong Society of Clinical Chemistry) for their assistance in disseminating the surveys. We thank Bernard Gouget and Eduardo Luis Freggiaro for helping with the French and Spanish translation of the survey, respectively. We also thank the pilot laboratories for providing the valuable feedback that improved the content of the survey. Finally, we thank all the survey participants for taking their time and effort in providing their response to the survey.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med 2020;382:727–33.
World Health Organisation. WHO Director-General’s remarks at the media briefing on 2019-nCoV on 11 February 2020. https://www.who.int/dg/speeches/detail/who-director-general-s-remarks-at-the-media-briefing-on-2019-ncov-on-11-february-2020 (Last accessed: 1 May 2020).
Lippi G, Plebani M. The critical role of laboratory medicine during coronavirus disease 2019 (COVID-19) and other viral outbreaks. Clin Chem Lab Med 2020;58:1063–9.
Binnicker MJ. Emergence of a novel coronavirus disease (COVID-19) and the importance of diagnostic testing: why partnership between clinical laboratories, public health agencies, and industry is essential to control the outbreak. Clin Chem 2020;66:664–6.
- Export Citation
Binnicker MJ. Emergence of a novel coronavirus disease (COVID-19) and the importance of diagnostic testing: why partnership between clinical laboratories, public health agencies, and industry is essential to control the outbreak. Clin Chem 2020;66:664–6.)| false 32077933 10.1093/clinchem/hvaa071
Hawkins R. Preparing the biochemistry laboratory for the next outbreak: lessons from SARS in Singapore. Clin Biochem Rev 2005;26:59–64.
Verbeek JH, Ijaz S, Mischke C, Ruotsalainen JH, Mäkelä E, Neuvonen K, et al. Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff. Cochrane Database Syst Rev 2020;4:CD011621.
Loh TP, Horvath AR, Wang C-B, Koch D, Adeli K, Mancini N, et al. Laboratory practices to mitigate biohazard risks during the COVID-19 outbreak: an IFCC global survey. Clin Chem Lab Med 2020. https://doi.org/10.1515/cclm-2020-0711 [Epub ahead of print].
Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in different types of clinical specimens. JAMA 2020;323:1843–4.
Wu J, Liu J, Li S, Peng Z, Xiao Z, Wang X, et al. Detection and analysis of nucleic acid in various biological samples of COVID-19 patients. Travel Med Infect Dis 2020;101673.
Chen Y, Chen L, Deng Q, Zhang G, Wu K, Ni L, et al. The presence of SARS-CoV-2 RNA in the feces of COVID-19 patients. J Med Virol 2020 Apr 3. doi: 10.1002/jmv.25825 [Epub ahead of print].
Peng L, Liu J, Xu W, Luo Q, Chen D, Lei Z, et al. SARS-CoV-2 can be detected in urine, blood, anal swabs, and oropharyngeal swabs specimens. J Med Virol 2020 Apr 24. doi: 10.1002/jmv.25936 [Epub ahead of print].
Zheng S, Fan J, Yu F, Feng B, Lou B, Zou Q, et al. Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study. Br Med J 2020;369:m1443.
Lescure FX, Bouadma L, Nguyen D, Parisey M, Wicky PH, Behillil S, et al. Clinical and virological data of the first cases of COVID-19 in Europe: a case series. Lancet Infect Dis 2020 Mar 27. pii: S1473-3099(20)30200-0. doi: 10.1016/S1473-3099(20)30200-0 [Epub ahead of print].
Yeo C, Kaushal S, Yeo D. Enteric involvement of coronaviruses: is faecal–oral transmission of SARS-CoV-2 possible? Lancet Gastroenterol Hepatol 2020;5:335–7.
Lippi G, Adeli K, Ferrari M, Horvath AR, Koch D, Sethi S, et al. Biosafety measures for preventing infection from COVID-19 in clinical laboratories: IFCC Taskforce Recommendations. Clin Chem Lab Med 2020;58:1063–9.
Furukawa NW, Brooks JT, Sobel J. Evidence supporting transmission of severe acute respiratory syndrome coronavirus 2 while presymptomatic or asymptomatic. Emerg Infect Dis 2020;26. [Epub ahead of print].
Arons MM, Hatfield KM, Reddy SC, Kimball A, James A, Jacobs JR, et al. Presymptomatic SARS-CoV-2 infections and transmission in a skilled nursing facility. N Engl J Med 2020 Apr 24. doi: 10.1056/NEJMoa2008457 [Epub ahead of print].
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-0710).