Issues in the practical implementation of POCT: overcoming challenges

References

• Stephans EJ, Conti G, Keane M, et al. Does the economic downturn impact point of care? Point Care. 2009;8(4):141–144.
   Google Scholar
• Jani IV, Peter TF. How point-of care testing could drive innovation in global health. N Engl J Med. 2013;368(24):2319–2324.
   PubMed Web of Science ®Google Scholar
• Marshburn TH, Hadfield CA, Sargsyan AE, et al. New heights in ultrasound: first report of spinal ultrasound from the international space station. J Emerg Med. 2014;46(1):61–70.
   PubMed Web of Science ®Google Scholar
• Johnson M, Lewandrowski KB. Analysis of emergency department test ordering patterns in an urban academic medical center: Can the point-of-care option in a satellite laboratory provide sufficient menu to permit full service testing. Point Care 2007;6(2):134–138.
   Google Scholar
• Kavsak PA, Zielinski N, Li D, et al. Chanllenges of implementing point-of-care testing (POCT) glucose meters in a pediatric acute care setting. Clinical Biochem. 2004;37(9):811–817.
   Google Scholar
• Fiallos MR, Hanhan UA, Orlowski JP. Point-of-care testing. Pediatr Clin North Am. 2001;48(3):589–599.
   PubMed Web of Science ®Google Scholar
• Nichols JH, Poe SS. Quality assurance, practical management, and outcomes of point-of-care testing: laboratory perspectives, part I. J CLMA. 1999;13:341–350.
   Google Scholar
• Poe SS, Nichols JH. Quality assurance, practical management, and outcomes of point-of-care testing: laboratory perspectives, part II. J CLMA. 2000;14:12–18.
   Google Scholar
• Public Health Service Act. §353, 42 USC §262a [Internet]. 1988 [cited 2016 Jan]. Available from: http://www.gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf.
   Google Scholar
• U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA programs: regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Fed Regist. 1992;57(40):7002–7186.
   PubMedGoogle Scholar
• Ehrmeyer SS, Laessig RH. Regulatory requirements (CLIA ’88, JCAHO, CAP) for decentralized testing. Am J Clin Pathol. 1995;104(4 Suppl 1):S40–S49.
   Google Scholar
• Joint Commission on Accreditation of Healthcare Organizations. Comprehensive accreditation manual for pathology and clinical laboratory services. Oakbrook Terrace (IL): JCAHO; 2001.
   Google Scholar
• College of American Pathologists, Commission on Laboratory Accreditation. Point-of-care testing checklists. Northfield (IL): CAP; 2001.
   Google Scholar
• College of American Pathologists. Standards for laboratory accreditation. Northfield (IL): CAP; 1999.
   Google Scholar
• Duffy WJ, Kharasch MS, Du H. Point of care documentation impact on the nurse-patient interaction. Nurs Adm Q. 2010;34(1):E1–E10.
   Google Scholar
• Kohle-Ersher A, Chatterjee P, Osmanbeyoglu HU, et al. Evaluating the barriers to point-of-care documentation for nursing staff. Comput Inform Nurs. 2012;30(3):126–133.
   PubMed Web of Science ®Google Scholar
• Dyhdalo KS, Howanitz PJ, Wilkinson DS, et al. Documentation of quality control and operator training at point-of-care testing: a College of American Pathologists Q-Probes study of 106 institutions. Arch Pathol Lab Med. 2014;138(11):1444–1448.
   PubMed Web of Science ®Google Scholar
• Park KS, Heo H, Choi YK. Design and realization of integrated management system for data interoperability between point-of-care testing equipment and hospital information system. Healthc Inform Res. 2013;19(3):222–228.
   Google Scholar
• Main RI, Kiechle FL. Point-of-care testing: administration within a health system. Lab Med. 2000;31(8):453–460.
   Google Scholar
• Carney DM, Bistline B. Validating nursing competencies using a fair format. J Nurses Staff Dev. 2008;24(3):124–128.
   Google Scholar
• Shephard MD, Mazzachi BC, Watkinson L, et al. Evaluation of a training program for device operators in the Australian government's point of care testing in general practice trial: issues and implications for rural and remote practices. Rural Remote Health. 2009;9(3):1189.
   Google Scholar
• Nichols JH. Point of care testing. Clin Lab Med. 2007;4:893–908.
   Web of Science ®Google Scholar
• Louie RF, Ferguson WJ, Curtis CM, et al. Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers. Clin Chem Lab Med. 2014;52(3):325–335.
   PubMed Web of Science ®Google Scholar
• Nichols JH. Blood glucose testing in the hospital: error sources and risk management. J Diabetes Sci Technol. 2011;5(1):173–177.
   PubMedGoogle Scholar
• Howerton D, Anderson N, Bosse D, et al. Good laboratory practices for waived testing sites: survey findings from testing sites holding a certificate of waiver under the clinical laboratory improvement amendments of 1988 and recommendations for promoting quality testing. Morb Mortal Wkly Rep. 2005;54(RR–13):1–4.
   PubMedGoogle Scholar
• Bayer Corporation. MultiStix 10SG, Multistix 9, Multistix 9SG, Multistix 8SG, Multistix 7, N-Multistix SG, N-Multistix, Multistix SG, Multistix, Bili-Labstix reagent strips package insert, AN30516D. Elkhardt (IN): Bayer Healthcare, LLC; 2005.
   Google Scholar
• Bamberg R, Schulman K, MacKenzie M, et al. Effect of adverse storage conditions on performance of glucometer test strips. Clin Lab Sci. 2005;18(4):203–209.
   PubMedGoogle Scholar
• Nichols JH, Rauch CA. Clinical chemistry: quality in laboratory diagnosis. New York (NY): Demos Medical; 2014.
   Google Scholar
• Martin CL. Quality Control issues in point of care testing. Clin Biochemist Rev. 2008;29(Suppl 1):S79–S82.
   PubMedGoogle Scholar
• Lewandrowski K, Gregory K, Macmillan D. Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management. Arch Pathol Lab Med. 2011;135(11):1405–1414.
   PubMed Web of Science ®Google Scholar
• Clark KS. Management challenges with point-of-care testing. Point Care. 2008;12(2):97–98.
   Google Scholar
• Taylor BM, DeJear L, Teehee M. The role of education and point of care use in appropriate surface disinfection compliance. Am J Infect Control. 2013;41(6):S130.
   Google Scholar
• Louie RF, Lau MJ, Lee JH, et al. Multicenter study of the prevalence of blood contamination on point of care glucose meters and recommendations for controlling contamination. Point Care. 2005;4:158–163.
   Google Scholar
• CDC. Notes from the field: deaths from acute hepatitis B virus infection associated with assisted blood glucose monitoring in an assisted living facility—North Carolina, August–October 2010. MMWR Morb Mortal Wkly Rep. 2011;60:182.
   PubMedGoogle Scholar
• CDC. Multiple outbreaks of hepatitis B virus infection related to assisted monitoring of blood glucose among residents of assisted living facilities—Virginia, 2009–2011. MMWR Morb Mortal Wkly Rep. 2012;61:339–343.
   PubMedGoogle Scholar
• Thompson ND, Schaefer MK. Never events: hepatitis B outbreaks and patient notifications resulting from unsafe practices during assisted monitoring of blood glucose, 2009–2010. J Diabetes Sci Technol. 2011;5:1396–1402.
   PubMedGoogle Scholar
• Infection prevention during blood glucose monitoring and insulin administration. Centers for Disease Control and Prevention. Atlanta (GA): National Center for Emerging and Zoonotic Infectious Diseases (NCEZID); 2013 [cited 2013 Feb 6]. Available from: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
   Google Scholar
• Nichols JH. Estimated strip wastage from glucose meter infection control recommendations. Clin Chim Acta. 2012;414:91–92.
   PubMed Web of Science ®Google Scholar
• Tonyushkina K, Nichols JH. Glucose Meters: A review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009;3(4):971–980.
   PubMedGoogle Scholar
• Gentile NL, Louie RF, Sifontes J, et al. Standardization, harmonization, and realization. Point Care. 2008;7(3):110–112.
   PubMedGoogle Scholar
• Armbruster D, Miller RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global approach to promote the standardization of clinical laboratory test results. Clin Biochem Rev. 2007;28(3):105–114.
   PubMedGoogle Scholar
• Louie RF, Ferguson WJ, Sumner SL, et al. Effects of dynamic temperature and humidity stresses on point-of-care glucose testing or disaster care. Disaster Med Public Health Prep. 2012;6:232–240.
   PubMed Web of Science ®Google Scholar
• Ferguson WJ, Vy JH, Louie RF, et al. Preliminary evaluation of a point-of-care blood gas-electrolyte analyzer potentially robust in cold during emergencies and disasters: Evidence from evaluation of reagents in stress testing chambers. Point of Care. 2012;11:152–156.
   Google Scholar
• Louie RF, Ferguson WJ, Curtis CM, et al. Effects of environmental conditions on point-of-care cardiac biomarker test performance during a simulated rescue: Implications for emergency and disaster response. Am J Disaster Med. 2013;8(3):205–212.
   PubMedGoogle Scholar
• Louie RF, Sumner SL, Belcher S, et al. Thermal stress and point-of-care testing performance: Suitability of glucose test strips and blood gas cartridges for disaster response. Disaster Med Public Health Prep. 2009;3(1):13–17.
   PubMedGoogle Scholar
• Vashist SK, Luppa PB, Yeo LY. Emerging technologies for next-generation point-of-care testing. Trends Biotechnol. 2015;33(11):692–705.
   PubMed Web of Science ®Google Scholar
• Huckle D. The impact of new trends in POCTs for companion diagnostics, non-invasive testing and molecular diagnostics. Expert Rev Mol Diagn. 2015;15(6):815–827.
   PubMed Web of Science ®Google Scholar
• Martínez-Mancera FD, García-López P, Hernández-López JL. Pre-clinical validation study of a miniaturized electrochemical immunoassay based on square wave voltammetry for early detection of carcinoembryonic antigen in human serum. Clin Chim Acta. 2015;15(444):199–205.
   Web of Science ®Google Scholar
• Ahmed MU, Saaem I, Wu PC, et al. Personalized diagnostics and biosensors: a review of the biology and technology needed for personalized medicine. Crit Rev Biotechnol. 2014;34(2):180–196.
   PubMed Web of Science ®Google Scholar