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Case report

Clinical laboratories in the era of the COVID-19 pandemic: An analysis of experiences in Serbia

Sanja Stanković1,2, Milika Ašanin1,3
  • University Clinical Center of Serbia, Belgrade, Serbia
  • Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia
  • Faculty of Medicine, University of Belgrade, Belgrade, Serbia

ABSTRACT

The COVID-19 pandemic represents one of the most serious public health threats that our world has faced in recent history. Clinical laboratories play a significant role in the global fight against this pandemic. This paper is based on the experiences of the Center for Medical Biochemistry of the University Clinical Center of Serbia. Using mixed methods research, the study sheds light on the many challenges that the Center has been facing during the pandemic, it outlines the implementation of change, and makes recommendations for functioning during the COVID-19 pandemic and in the post-COVID era.


INTRODUCTION

It has been almost two years since, in December 2019, in the city of Wuhan, in the Chinese province of Hubei, the seventh human corona virus - SARS-CoV-2, which causes severe acute respiratory syndrome, and which is dominantly a droplet and contact infection, was identified. On January 30, 2020, the World Health Organization declared the COVID-19 infection a public health emergency of international concern, and on March 11, 2020, it declared the pandemic of COVID-19 [1]. Since the beginning of the epidemic, 200 million cases of COVID-19 infection have been registered, while more than 4.2 million deaths have been reported in 222 countries worldwide [2].

The COVID-19 pandemic represents one of the most serious public health threats that our world has faced in recent history. In the global fight against this pandemic, clinical laboratories have had an important role. Since the beginning of the pandemic, laboratory workers have been, selflessly and tirelessly, on the frontline of the fight against the COVID-19 infection, both in laboratories in the public, as well as in the private sector [3].

Clinical laboratories are in the focus of attention exclusively for their very significant role in molecular testing, SARS-CoV-2 RNA detection, and serological monitoring [4]. On the other hand, initially, the operation of clinical biochemistry laboratories, just like in previous pandemics, was not given great importance, either in professional circles or in the public eye. However, during this lasting crisis, it has transpired that timely provided service and the quality of clinical biochemistry laboratory diagnostics, in the sense of initial diagnostic patient examinations, as well as biochemical monitoring of inflammation biomarkers/multiorgan dysfunction of hospitalized patients suffering from the severe form of COVID-19 and with complications, is of invaluable importance for public health and safety.

AIM

The aim of this paper is to describe the practical experiences of clinical laboratory management during the pandemic, with a special overview of the experience of the Center for Medical Biochemistry of the University Clinical Center of Serbia (CMB-UCCS).

METHODS

The method applied in this paper is a combined description of an overview of rules and regulations and the activities carried out in the field. Using the example of the observed unit of UCCS, the challenges, necessary changes, and the implementation of the changes have been described, and recommendations on functioning during the COVID-19 pandemic, and in the post-COVID era, have been given.

CHALLENGES IN THE OPERATION OF CLINICAL LABORATORIES

At a very turbulent time of the COVID-19 pandemic, clinical laboratories all over the world have faced numerous challenges, primarily related to the appropriate organization of routine work. During the pandemic, previous long-lasting weaknesses of the laboratories have become an impediment to readiness and quick response. As regards to COVID-19, the routine work of clinical laboratories is a multicomponent process comprising the identification of the virus in patient samples, laboratory support in patient treatment, but also clinical follow-up and prognosis, as well as involvement in research of the course of the illness and therapeutic approaches.

Understaffing, limited investment budgets, as well as increased pressure to improve the satisfaction of service users with the service, have proven to be preexisting weaknesses of laboratories, which have become even more evident during the pandemic. Additional challenges, such as: working with equipment which has low capacity and is often outdated; difficulties for the medical equipment service engineer, as well as for the employees to come to the laboratory, due to contextual changes, such as ‘lockdown’; facing the possibility of prolonged jeopardy to the reagents and consumables supply chain; have all put the competencies and readiness of laboratory management and staff to operate in public health crisis situations, to the test.

The scope and type of laboratory diagnostics have been adjusted to the needs of service users in the institutions, often drastically decreased and limited only to patients with acute or emergency conditions, while in some laboratories, analyses of tests requiring manual manipulation, have been limited [5]. A very important aspect of the COVID-19 pandemic is the danger to health workers [6],[7], including laboratory employees, which is why the implementation of appropriate safety and protection measures is very important, in a situation where the infection and quarantine are decreasing the number of active healthcare workers and placing an additional burden on already overstrained healthcare systems. The space in some of the laboratories was often insufficient to maintain the prescribed physical distance which is why it required primarily physical restructuring.

In Serbia, in the newly arisen situation, when the speed and manner of disease spread, the symptoms, the severity and outcome of the disease, were unknown, and when new knowledge emerged every day, clinical laboratories were faced with great challenges and the implementation of necessary changes.

At the time of the beginning of the COVID-19 pandemic, the Center for Medical Biochemistry of the University Clinical Center of Serbia, a referral center of tertiary healthcare level in the Republic of Serbia (RS), was organized in 14 locations, with 225 employees, of whom 34 medical biochemists and 163 medical laboratory technicians. The main activity of this powerful Center is providing modern laboratory diagnostic services in the area of biochemistry, immunochemistry, laboratory hematology, coagulation, and immunology, as well as emergency laboratory diagnostics. The Center offers its services to clinics and centers of the UCCS, to ambulatory patients, as well as to other healthcare institutions in Belgrade and the Republic of Serbia. The CMB-UCCS was the first laboratory in the country to introduce a quality management system in keeping with the standards ISO 9001, ISO/IEC 17025, and ISO 15189, and it has also been accredited by the Agency for Accreditation of Health Care Institutions of Serbia.

Organizationally speaking, the expectation of the tertiary level healthcare institutions has been that the laboratory should continue its operation 24/7 during the pandemic, while the expectation of the patients has been that, regardless of the extraordinary circumstances, they should continue to receive their laboratory test results. Increased pressure that laboratory test results should be available in a timely fashion, for a large number of samples submitted at the same time; that laboratory analyses should be carried out quickly and expertly, so that necessary treatment should be administered as soon as possible in COVID-19 patients; but also, that the continuity of providing services to emergency non-COVID-19 patients and patients with chronic non-infectious diseases should be maintained; has been an additional burden for laboratory staff.

One of the major challenges of this pandemic has been the protection of laboratory staff against biohazards. Although, as an accredited laboratory, the CMBUCCS has defined a Risk Management Strategy, which defines risks, the possibilities of their occurrence, the possible consequences, as well as the activities that the CMB, as a part of the UCCS, has been undertaking in order to lower, i.e., eliminate the risk of adverse events, COVID-19 has placed before the CMB numerous challenges in that respect. These challenges have primarily been in the domain of the transportation and handling of biological material, the decontamination of equipment and work surfaces, the maintenance of personal hygiene, and the use of personal protective equipment. The absence of a number of the staff due to infection or self-isolation/quarantine has also been a challenge. This has especially been the case with cleaning staff, who are in frequent communication with several laboratory areas/laboratories.

CHANGES IN THE OPERATION OF LABORATORIES AND THEIR IMPLEMENTATION

It is evident that the pandemic has affected the routine operation of the CMB. Organizationally speaking, in the COVID-19 era, CMB has been carrying out laboratory work at an additional location, in the new COVID hospital of the UCCS, in Batajnica, Belgrade. The management of the center had the great responsibility of establishing, within a very short time frame, a laboratory that would conform to all the principles of good laboratory practice, while observing all the required measures for medical waste management and all the recommendations for the healthy and safe work of the staff. Equipment installation, as well as staff training for operating the said equipment was carried out. The purchase of commercial reagents and consumables as well as methods verification was performed. Internal quality control of the work in the laboratory, as well as inter-laboratory comparison with other laboratories of the CMB was carried out, as was the networking of analyzers within the laboratory and vertical networking of the laboratory with the departments of the COVID hospital and the organizational units of the laboratory at the UCCS, etc. POCT blood gas anayzer were installed and put into operation at the hospital intensive care units.

Staff was assigned according to momentary needs, but the Ministry of Health of the Republic of Serbia also enabled the hiring of new staff (medical biochemists and laboratory technicians), mainly for the needs of the laboratory at the hospital of the UCCS, in Batajnica. The hiring of these employees was followed by intensive training of the newly employed staff in all segments of laboratory operation.

Because of staff absences, due to infection or self-isolation/quarantine, work in teams has been organized, in order to limit exposure to infection. Meal breaks are made in small groups, in rooms with natural ventilation and a limited number of seats, while maintaining the required physical distance.

Every day, the management makes and controls operational work plans which enable the laboratory to respond to set priorities with the resources that it has at its disposal. Physical distancing has necessitated a different mode of communication, handover and service continuity amongst the teams. Maintenance of work discipline and morale, as well as the management of staff anxiety, stemming from physical distancing and the inability to communicate during breaks, has been a special challenge for the management.

The CMB has maintained continuous service delivery throughout the pandemic, both to COVID-19 patients and to emergency non-COVID patients, as well as to patients with chronic noninfectious diseases. CMB has kept abreast of the epidemiological situation and the organization of the UCCS, analyzing, from the very beginning of the pandemic, the samples of biological material taken from COVID-19 patients treated at the Clinic for Infectious and Tropical Diseases, and at the provisional COVID hospitals at the UCCS clinics (Clinic for Pulmonology, Clinic for Thoracic Surgery, Clinic for Plastic and Reconstructive Surgery, Clinic for Dermatovenerology), as well as the samples of patients hospitalized at the provisional COVID hospital Štark Arena, and, as of December 2020, laboratory analyses are being performed at the laboratory of the new UCCS COVID hospital in Batajnica. Since the start of the epidemic, the Center has provided approximately 2.6 million tests to COVID-19 positive patients, which is roughly 20% of the overall services delivered in this period.

An increase in the number of automatized tests, necessary for COVID-19 diagnostics, follow-up of the course of the disease and complications, as well as the therapy applied (e.g., D-dimer, C-reactive protein, ferritin, procalcitonin, interleukin-6, blood gas analyses, troponin, etc.) has been registered. The existence of two total laboratory automations, in the two largest organizational units of the Center, enables that the complete work process, from the moment of blood sampling completion in the laboratory to the moment when the test results are issued, is fully automated, which reduces contact of the staff with biological material to a minimum. Apart from the installation of total laboratory automation, the equipment in the CMB was renewed in the previous several years, which is why, at the beginning of the pandemic, only several more POCT analyzers were installed in intensive care units and test verification was performed. At the beginning of the epidemic, the CMB provided sufficient supplies of reagents and consumables, thus avoiding the disruption of the supply chain.

During the pandemic, the CMB has been performing venipuncture and analyzing samples from patients with chronic noninfectious diseases, patients with different numerous acute conditions, as well as in-patients of the UCCS. The transport and receipt of samples from patients with suspected or confirmed COVID-19 infection, the pre-analysis and analysis phase of the laboratory process, sample storage, as well as waste disposal, have been carried out in keeping with the current recommendations and procedures of the CMB [8].

mmendations and procedures of the CMB [8]. In this context, efforts have been made to reduce irrational fear, through personal protection and laboratory safety measures training, and through introducing increased caution (daily body temperature check, etc.), as well as transmission prevention measures (mandatory personal protective equipment - face masks, gloves, goggles, face shields, gowns, increased personal hygiene, hand disinfection, work surface disinfection, a two-meter physical distance between employees in the laboratory, etc.). All staff are regularly informed on all the memos and recommendations of the Ministry of Health of the Republic of Serbia pertaining to COVID-19 (treatment protocol, workplace safety measures, vaccination, etc.).

During the COVID-19 pandemic, the CMB-UCCS has been forced to change the mode of implementing continuous medical training. Congresses, traditionally organized by the CMB, every year, which usually host more than 3,000 participants, have been replaced with online tests, accredited by the Health Council of the Republic of Serbia, whereby the participants were provided with the opportunity of gaining new insights into current topics (biochemical, serological, and molecular diagnostics in COVID-19, biomarkers of interstitial lung disease and pneumonia), as well as procuring the requisite number of points necessary for their license renewal.

RECOMMENDATIONS FOR FUNCTIONING DURING THE COVID-19 PANDEMIC AND IN THE POST-COVID ERA

The fight against the COVID-19 pandemic is ongoing and it brings with it new challenges for all, including laboratories. Globally, COVID-19 is threatening to jeopardize the progress made in achieving the third goal of sustainable development of the United Nations, which is related to ensuring healthy lives and promoting well-being for all people [9]. Thus, the common goal is to stop the existing threat, increase accessibility of health care, strengthen capacities for expanding health care, provide necessary health services in a timely manner, protect and save people, and decrease costs resulting from COVID-19 in the future, when the effects of the health crisis occurring now will be dominant. The UCCS managerial experience tells us that, in order to lessen the effect of COVID-19 on healthcare systems, five public policy areas should be focused on:

  1. stopping the infection spread,
  2. budget management,
  3. ensuring service provision, and
  4. recovery to the level that is considered the new normal [10].

As far as laboratories are concerned, the COVID-19 pandemic has clearly shown us the goals of the four major stakeholders:

  1. for patients – to receive timely quality service;
  2. for laboratory staff – to have all the necessary conditions for safe and quality work involving less stress and a higher level of motivation;
  3. for laboratory management – to operate according to predefined procedures, without the need for ad hoc decisions, and to be under less pressure while achieving better outcomes for their institutions; and
  4. for distributers – to purchase equipment and consumables on time and to distribute them to their customers without any difficulties.

It is only the progress in the fight against the pandemic that will be able to reveal the strengths and weaknesses of laboratories. Short-term measures of reacting to extraordinary circumstances should be completed with long-term planning. In order for the systems to be prepared for future pandemics and ready to respond to the goals of the patients and other stakeholders, the laboratories should apply a proactive approach. It is necessary to form teams for crisis situations made up of laboratory staff with the appropriate training. For instance, teams for venipuncture of the most vulnerable citizen groups in conditions of reduced mobility, should be formed. This would reduce public health costs for procuring the services of private laboratories. Laboratories should establish standard operational procedures for risk management, in keeping with the policies for operating in extraordinary situations. This would also ensure that the supply chain is not threatened.

It is necessary to design a strategy of laboratory testing based on clear scientific evidence, which should also include the optimization of the supply chain, service delivery, and biological waste disposal. This is a real opportunity to strategically perform a needs assessment regarding staff, based on the workload prior to and during the crisis (use of the WISN method), and thereby raise the level of readiness for a crisis situation and decrease the draining of resources during a crisis. The fear of losing one’s job and suffering a wage cut creates additional pressure in staff, whose mental status is, in most cases, already altered, as their everyday work in the current circumstances puts their lives and the lives of their loved ones at risk. Managers should be supported in their work, in order to be able to maintain high motivation for efficient functioning, by applying monetary and non-monetary motivation strategies. Generally speaking, budget funds should be redirected into providing incentives and different forms of compensation, as well as ensuring the safety and health of the staff.

The norms of conduct during the COVID-19 pandemic, such as physical distancing, not only reduce risk exposure, but they also modify the work culture. Online meetings and consultations should be included into everyday activities, while celebrations and social events in the workplace should be discontinued. Meal breaks should be taken in groups, in rooms with a limited number of seats and the meals should be safely preprepared and prepackaged.

CONCLUSION

The challenges and changes resulting from the COVID-19 pandemic are a reminder that, in addition to our main task, we must continuously improve in different areas. At the present time, laboratory staff have the unique opportunity of applying the knowledge and insights they have gained during the pandemic into transforming the way that they work and reducing the effects of future pandemics.

From today’s viewpoint, the main precondition is that laboratories should have the sufficient number of staff, in order to be flexible in their work. It is also important that the staff is equipped with the appropriate personal protective equipment and resources for work, as well as that the management is experienced and prepared for efficient operation during a crisis, while applying motivation strategies and strategies for promoting mental and physical health.

Having learned from this experience, once the pandemic is finally over, we should be able to conclude that the laboratories have become stronger than ever before, both organizationally and professionally, and ready for numerous challenges that lie ahead.

  • Conflict of interest:
    None declared.

Informations

Volume 2 No 3

September 2021

Pages 286-294
  • Keywords:
    pandemic, clinical laboratories, medical biochemistry, COVID-19, Serbia
  • Received:
    05 August 2021
  • Revised:
    08 August 2021
  • Accepted:
    09 August 2021
  • Online first:
    30 September 2021
  • DOI:
  • Cite this article:
    Stanković S, Ašanin M. Clinical laboratories in the era of the COVID-19 pandemic: An analysis of experiences in Serbia. Serbian Journal of the Medical Chamber. 2021;2(3):286-94. doi: 10.5937/smclk2-33424
Corresponding author

Sanja Stanković
University Clinical Center of Serbia
26 Višegradska Street, 11000 Belgrade
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.


  • 1. World Health Organization. Novel Coronavirus (2019-nCoV) Situation reports. [Internet]. [Accessed on 30 March 2020]. Available on:https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports

    2. Worldometers.info. Dover, Delaware, U.S.A. [Internet]. [Accessed on 1 August 2021]. Available on: https://www.worldometers.info/coronavirus

    3. Adeli K. Critical role of laboratory medicine in the global response to the COVID-19 pandemic. Clin Chem Lab Med. 2020;58(7):1019-20.[CROSSREF]

    4. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections - the state of the art. Emerg Microbes Infect. 2020;9(1):747-56.[CROSSREF]

    5. Loh TP, Horvath AR, Wang CB, Koch D, Adeli K, Mancini N, et al. International Federation of Clinical Chemistry and Laboratory Medicine Taskforce on COVID-19. Operational considerations and challenges of biochemistry laboratories during the COVID-19 outbreak: an IFCC global survey. Clin Chem Lab Med. 2020;58(9):1441-9.[CROSSREF]

    6. Bowdle A, Munoz-Price LS. Preventing Infection of Patients and Healthcare Workers Should Be the New Normal in the Era of Novel Coronavirus Epidemics. Anesthesiology. 2020;132(6):1292-5.[CROSSREF]

    7. Wu Z, McGoogan JM. Characteristics of and Important Lessons from the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239-42.[CROSSREF]

    8. 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(7):1053-62.[CROSSREF]

    9. The Lancet Public Health. Will the COVID-19 pandemic threaten the SDGs? Lancet Public Health. 2020;5(9):e460.[CROSSREF]

    10. The World Bank Group. Zapadni Balkan Redovni ekonomski izvještaj br.17/ proljeće 2020. Zdravstveni sistemi. Ekonomski i socijalni uticaj COVID-19. [Internet]. [Accessed on 1 May 2021]. Available on: https://www.worldbank.org/eca/wbrer


REFERENCES

1. World Health Organization. Novel Coronavirus (2019-nCoV) Situation reports. [Internet]. [Accessed on 30 March 2020]. Available on:https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports

2. Worldometers.info. Dover, Delaware, U.S.A. [Internet]. [Accessed on 1 August 2021]. Available on: https://www.worldometers.info/coronavirus

3. Adeli K. Critical role of laboratory medicine in the global response to the COVID-19 pandemic. Clin Chem Lab Med. 2020;58(7):1019-20.[CROSSREF]

4. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections - the state of the art. Emerg Microbes Infect. 2020;9(1):747-56.[CROSSREF]

5. Loh TP, Horvath AR, Wang CB, Koch D, Adeli K, Mancini N, et al. International Federation of Clinical Chemistry and Laboratory Medicine Taskforce on COVID-19. Operational considerations and challenges of biochemistry laboratories during the COVID-19 outbreak: an IFCC global survey. Clin Chem Lab Med. 2020;58(9):1441-9.[CROSSREF]

6. Bowdle A, Munoz-Price LS. Preventing Infection of Patients and Healthcare Workers Should Be the New Normal in the Era of Novel Coronavirus Epidemics. Anesthesiology. 2020;132(6):1292-5.[CROSSREF]

7. Wu Z, McGoogan JM. Characteristics of and Important Lessons from the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239-42.[CROSSREF]

8. 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(7):1053-62.[CROSSREF]

9. The Lancet Public Health. Will the COVID-19 pandemic threaten the SDGs? Lancet Public Health. 2020;5(9):e460.[CROSSREF]

10. The World Bank Group. Zapadni Balkan Redovni ekonomski izvještaj br.17/ proljeće 2020. Zdravstveni sistemi. Ekonomski i socijalni uticaj COVID-19. [Internet]. [Accessed on 1 May 2021]. Available on: https://www.worldbank.org/eca/wbrer

1. World Health Organization. Novel Coronavirus (2019-nCoV) Situation reports. [Internet]. [Accessed on 30 March 2020]. Available on:https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports

2. Worldometers.info. Dover, Delaware, U.S.A. [Internet]. [Accessed on 1 August 2021]. Available on: https://www.worldometers.info/coronavirus

3. Adeli K. Critical role of laboratory medicine in the global response to the COVID-19 pandemic. Clin Chem Lab Med. 2020;58(7):1019-20.[CROSSREF]

4. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections - the state of the art. Emerg Microbes Infect. 2020;9(1):747-56.[CROSSREF]

5. Loh TP, Horvath AR, Wang CB, Koch D, Adeli K, Mancini N, et al. International Federation of Clinical Chemistry and Laboratory Medicine Taskforce on COVID-19. Operational considerations and challenges of biochemistry laboratories during the COVID-19 outbreak: an IFCC global survey. Clin Chem Lab Med. 2020;58(9):1441-9.[CROSSREF]

6. Bowdle A, Munoz-Price LS. Preventing Infection of Patients and Healthcare Workers Should Be the New Normal in the Era of Novel Coronavirus Epidemics. Anesthesiology. 2020;132(6):1292-5.[CROSSREF]

7. Wu Z, McGoogan JM. Characteristics of and Important Lessons from the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239-42.[CROSSREF]

8. 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(7):1053-62.[CROSSREF]

9. The Lancet Public Health. Will the COVID-19 pandemic threaten the SDGs? Lancet Public Health. 2020;5(9):e460.[CROSSREF]

10. The World Bank Group. Zapadni Balkan Redovni ekonomski izvještaj br.17/ proljeće 2020. Zdravstveni sistemi. Ekonomski i socijalni uticaj COVID-19. [Internet]. [Accessed on 1 May 2021]. Available on: https://www.worldbank.org/eca/wbrer


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