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Laboratory Processing of Specimens

  • Peter C. Iwen
  • Roxanne Alter
  • Vicki L. Herrera
  • Anthony R. Sambol
  • Karen L. Stiles
  • Steven H. Hinrichs
Chapter

Abstract

Although not always the first topic discussed when preparing for a bioemergency, the availability of a competent clinical laboratory is vital for the optimal care of a patient with a risk group 4 (RG-4) high-consequence pathogen. The recent development of highly specialized facilities in the United States to assess and treat patients with highly hazardous communicable diseases has led to the design of dedicated laboratories or the redesign of laboratory space to safely process and test specimens that might contain one of these pathogens. For frontline and other acute care facilities to be prepared, safety practices need to be assessed and reviewed as necessary as pertaining to all laboratory activities, to include the pre-analytical (specimen collection and processing), analytical (specimen testing), and post-analytical (specimen disposal/waste management and reporting) processes. Laboratorians and administrative personnel need to consider the risks in handling specimens containing these pathogens and subsequently develop or revise processes to mitigate risks. In addition, issues such as scalability to handle large volume testing, the availability of trained staff, and long-term sustainability to meet the requirements of regulatory agencies need to be adopted within a fiscally responsible budget setting. This chapter provides generalized information on how clinical laboratories, from those supporting small frontline medical facilities to highly specialized laboratories supporting acute care treatment centers, can safely manage specimens from a patient known or potentially infected with a high-consequence pathogen.

Keywords

Point of care Risk assessment Biosafety Sustainability RG-4 pathogen CLIA Specimen transport Essential tests Waste management Select agent 

References

  1. 1.
    Broadhurst MJ, Brooks TJG, Pollock NR. Diagnosis of Ebola virus disease: past, present, and future. Clin Microbio Rev. 2016;29(4):773–93.CrossRefGoogle Scholar
  2. 2.
    Polgreen PM, Santibanez S, Koonin LM, Rupp ME, Beekmann SE, Del Rio C. Infectious disease physician assessment of hospital preparedness for Ebola virus disease. Open Forum Infect Dis. 2015;2(3):1–6.CrossRefGoogle Scholar
  3. 3.
    Santibanez S, Polgreen PM, Beekmann SE, Rupp ME, Del Rio C. Infectious disease physicians’ perceptions about Ebola preparedness early in the US response: a qualitative analysis and lessons for the future. Health Security. 2016;14(5):345–50.CrossRefGoogle Scholar
  4. 4.
    Dubov A, Appleton JH, Campbell S. Ebola virus preparedness: emerging viruses and ethics in laboratory medicine. Arch Pathol Lab Med. 2016;140:171–80.CrossRefGoogle Scholar
  5. 5.
    Centers for Disease Control and Prevention. CDC guidance on personal protective equipment to be used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing). 2014. http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html. Accessed December 6, 2016.
  6. 6.
    Centers for Disease Control and Prevention. Procedures for safe handling and management of Ebola-associated waste. 2014. http://www.cdc.gov/vhf/ebola/healthcare-us/cleaning/handling-waste.html. Accessed March 1, 2018.
  7. 7.
    Centers for Disease Control and Prevention. Guidance for U.S. laboratories for managing and testing routine clinical specimens when there is a concern about Ebola virus disease. 2015. http://www.cdc.gov/vhf/ebola/healthcare-us/laboratories/safe-specimen-management.html. Accessed March 1, 2018.
  8. 8.
    Centers for Disease Control and Prevention. Guidance for collection, transport and submission of specimens for Ebola virus testing. 2015. http://www.cdc.gov/vhf/ebola/healthcare-us/laboratroies/specimens.html. Accessed March 1, 2018.
  9. 9.
    Centers for Disease Control and Prevention. Interim biosafety guidance for all individuals handling clinical specimens or isolates containing 2009-H1N1 Influenza A Virus (Novel H1N1), include Vaccine Strains. 2009. http://www.cdc.gov/h1n1flu/guidelines_labworkers.htm. Accessed March 1, 2018.
  10. 10.
    Centers for Disease Control and Prevention. Interim laboratory biosafety guidelines for handling and processing specimens associated with Middle East Respiratory Syndrome Coronavirus (MERS-CoV). 2016. http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html. Accessed March 1, 2018.
  11. 11.
    Iwen PC, Smith PW, Hewlett AL, Kratochvil CJ, Lisco SJ, Sullivan JN, et al. Safety considerations in the laboratory testing of specimens suspected or known to contain Ebola virus. Amer. J Clin Pathol. 2015;143(1):4–5.CrossRefGoogle Scholar
  12. 12.
    Department of Labor. Occupational Safety and Health Administration, Occupational Health and Safety Act of 1970, Section 5(a)1, Amended 1Jan2004 1970.Google Scholar
  13. 13.
    Centers for Disease Control and Prevention. Interim guidance for U.S. Hospital Preparednesss for Patients Under Investigation (PUIs) or with Confirmed Ebola Virus Disease (EVD): a framework for a tiered approach. 2015. http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/hospitals.html. Accessed March 1, 2018.
  14. 14.
    Centers for Disease Control and Prevention. Hospital preparedness: a tiered approach: interim guidance for preparing frontline healthcare facilities for Patient Under Investigation (PUIs) for Ebola Virus Disease (EVD). 2015. http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/frontline-healthcare-facilities.html. Accessed March 1, 2018.
  15. 15.
    Centers for Disease Control and Prevention. Hospital preparedness: a tiered approach: interim guidance for preparing Ebola assessment hospitals. 2015. http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/assessment-hospitals.html. Accessed March 1, 2018.
  16. 16.
    Centers for Disease Control and Prevention. Hospital preparedness: a tiered approach: interim guidance for preparing Ebola Treatment Centers. 2015. http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/treatment-centers.html. Accessed March 1, 2018.
  17. 17.
    Clinical and Laboratory Standards Institute (CLSI). Protection of laboratory workers from occupationally acquired infections; approved guideline. Wayne: Clinical and Laboratory Standards Institute; 2014.Google Scholar
  18. 18.
    Katz LM, Tobian AA. Ebola virus disease, transmission risk to laboratory personnel, and pretransfusion testing. Transfusion. 2014;54(12):3247–51.CrossRefGoogle Scholar
  19. 19.
    Wadman MC, Schwedhem SS, Watson S, Swanhorst J, Gibbs SG, Lowe JJ, et al. Emergency department processes for the evaluation and management of persons under investigation for Ebola virus disease. Ann Emer Med. 2015;66(3):306–14.CrossRefGoogle Scholar
  20. 20.
    Clinical and Laboratory Standards Institute. Procedures for the collection of diagnostic blood specimens by venipuncture: approved standard, Sixth Edition, CLSI document H3-A6. In: CLSI, 940 West Valley Road, Suite 1400, editor, Wayne, 19087–1898; 2007.Google Scholar
  21. 21.
    Hill CE, Burd E, Kraft CS, Ryan EL, Duncan A, Winkler AM, et al. Laboratory test support for Ebola patients within a high-containment facility. Lab Med. 2014;45(3):e109–e11.CrossRefGoogle Scholar
  22. 22.
    Department of Health and Human Services. 42CFR Part 73, Possession, use, and transfer of select agents and toxins: biennial review. Fed Regist. 2012;77(194):61084–115.Google Scholar
  23. 23.
    Centers for Disease Control and Prevention DHHS. Possession, use, and transfer of select agents and toxins; biennial review of the list of select agents and toxins and enhanced biosafety requirements. Fed Regist. 2017;82(12):6278–94.Google Scholar
  24. 24.
    Centers for Disease Control and Prevention. Malaria Diagnosis (U.S.) – Rapid Diagnostic Test. 2015. http://www.cdc.gov/malaria/diagnosis_treatment/rdt.html. Accessed March 1, 2018.
  25. 25.
    Owen W, Caron J, Genzen J. Liver function testing on the Abaxis Piccolo Xpress: use in Ebola virus disease protocols. Clin Chim Acta. 2015;446:119–27.CrossRefGoogle Scholar
  26. 26.
    Jelden KC, Gibbs SG, Smith PW, Hewlett AL, Iwen PC, Schmid KK, et al. Comparison of hospital room surface disinfection using a novel ultraviolet germicidal irradiation (UVGI) generator. J Occup Environ Hyg. 2016;13(9):690–8.CrossRefGoogle Scholar
  27. 27.
    Lowe JJ, Hewlett AL, Iwen PC, Smith PW, Gibbs SG. Case study: surrogate testing suggests that chlorine dioxide gas exposure would not inactivate Ebola virus contained in environmental blood contamination. J Occup Environ Hyg. 2015;12:D211–D5.CrossRefGoogle Scholar
  28. 28.
    Burnham C, Kwon J, Burd E, Campbell S, Iwen P, Miller MB. Are we there yet? Laboratory preparedness for emerging infectious diseases. Clin Chem. 2017;63(4):1–4.CrossRefGoogle Scholar
  29. 29.
    Cooks B, Cutts T, Nikiforuk A, Poliquin P, Court D, Strong J, et al. Evaluating environmental persistence and disinfection of the Ebola virus Makona variant. Viruses. 2015;7(4):1975–86.CrossRefGoogle Scholar
  30. 30.
    Ringen K, Landrigan PJ, Stull JO, Duffy R, Melius J, McDiarmid MA. Occupational safety and health protections against Ebola virus disease. Amer J Indust Med. 2015;58:703–14.CrossRefGoogle Scholar
  31. 31.
    Kwon E, Minhas V, Phiri T, Wood C, Swindells S, Hunsley BB, et al. Inactivation and viral load quantitation of human immunodeficiency virus in blood collected into Cyto-Chex BCT-blood collection device. J Virol Methods. 2014;196:50–5.CrossRefGoogle Scholar
  32. 32.
    Rosenstierne MW, Karlberg H, Bragstad K, Lindegren G, Stoltz ML, Salata C, et al. Rapid bedside inactivation of Ebola virus for safe nucleic acid tests. J Clin Microbiol. 2016;54(10):2521–9.CrossRefGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Peter C. Iwen
    • 1
  • Roxanne Alter
    • 1
  • Vicki L. Herrera
    • 1
  • Anthony R. Sambol
    • 1
  • Karen L. Stiles
    • 1
  • Steven H. Hinrichs
    • 2
  1. 1.Nebraska Public Health Laboratory, Department of Pathology and MicrobiologyUniversity of Nebraska Medical CenterOmahaUSA
  2. 2.College of Medicine, Department of Pathology and MicrobiologyUniversity of Nebraska Medical CenterOmahaUSA

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