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Chapter 25 : Management of Point-of-Care Testing

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Abstract:

Point-of-care testing (POCT) presents some of the most controversial and difficult laboratory management challenges. This chapter identifies how management of POCT differs from other types of laboratory testing. It describes cost factors in POCT and approaches for analysis of the costs of testing. One of the key initial steps in the management of POCT is the development of institutional goals. In developing the management structure for POCT, there are political issues that central administration and departmental leaders need to sort out. These include issues what department and who will direct testing, institutional priorities for POCT, and how costs and revenues will be assigned. The chapter explains how to operate a POCT program and to ensure the quality of testing. An important part of deciding whether a point-of-care test should be adopted is assessing its potential clinical impact. The chapter explains the challenges of implementing POCT in developing countries and the clinical benefit of POCT. One of the greatest challenges and a key to making POCT work is training and assurance of the competency of staff. The challenges of conducting quality POCT in developed countries with established hospital infrastructures are magnified when performed in the context of a developing country or rural setting. The chapter discusses how technological advances are driving change in the scope of POCT. Ongoing advances in the microfabrication of devices and in nanotechnology provide the promise of substantial future technological change and further reduction in the size of POCT devices.

Citation: Hortin G, Doern C. 2014. Management of Point-of-Care Testing, p 471-487. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch25

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References

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1. Aghokeng, A. F.,, L. Ewane,, B. Awazi,, A. Nanfack,, E. Delaporte,, M. Peeters,, and L. Zekeng. 2004. Evaluation of four simple/rapid assays and two fourth-generation ELISAs for the identification of HIV infection on a serum panel representing the HIV-1 group M genetic diversity in Cameroon. J. Acquir. Immune Defic. Syndr. 37: 1632 1640. [PubMed]
2. Alemnji, G.,, J. N. Nkengasong,, and B. S. Parekh. 2011. HIV testing in developing countries: what is required? Indian J. Med. Res. 134: 779 786. [PubMed][CrossRef]
3. Alves-Dunkerson, J. A.,, P. E. Hilsenrath,, G. A. Cress,, and J. A. Widness. 2002. Cost analysis of a neonatal point-of-care monitor. Am. J. Clin. Pathol. 117: 809 818. [PubMed][CrossRef]
4. Asimos, A. W.,, M. A. Gibbs,, J. A. Marx,, D. G. Jacobs,, R. J. Erwin,, H. J. Norton,, and M. Thomason. 2000. Value of point-of-care blood testing in emergent trauma management. J. Trauma 48: 1101 1108. [PubMed]
5. Boone, D. J.,, J. W. Hay,, J. Aguanno,, T. Getzen,, and G. Hortin. 2002. Are the correct economic factors influencing point-of-care testing? Point of Care 1: 212 221.
6. Chmielewski, S. A. 1995. Advances and strategies for glucose monitoring. Am. J. Clin. Pathol. 104: S59 S71. [PubMed]
7. College of American Pathologists. 2003. Point-of-care testing checklist. Laboratory Accreditation Program. College of American Pathologists, Northfield, IL.
8. De Cresce, R. P.,, D. L. Phillips,, and P. J. Howanitz. 1995. Financial justification of alternate site testing. Arch. Pathol. Lab. Med. 119: 898 901. [PubMed]
9. Despotis, G. J.,, J. E. Grishaber,, and L. T. Goodnough. 1994. The effect of an intraoperative treatment algorithm on physicians’ transfusion practice in cardiac surgery. Transfusion 34: 290 296. [PubMed]
10. Dessie, A.,, B. Abera,, F. Walle,, D. Wolday,, and W. Tamene. 2008. Evaluation of Determine HIV-1/2 rapid diagnostic test by 4th generation ELISA using blood donors’ serum at Felege Hiwot Referral Hospital, northwest Ethiopia. Ethiop. Med. J. 46: 1 5. [PubMed]
10a. Dunka, L. J. 2006. Point-of-Care Connectivity. Approved Standard, CLSI publication POCT1A2. Clinical Laboratory Standards Institute, Wayne, PA.
11. Ehrmeyer, S. 2003. Using a creatinine ratio in urinalysis to improve the reliability of protein and albumin results. MLO Med. Lab. Obs. 35: 26 30. [PubMed]
12. Ehrmeyer, S. S.,, and R. H. Laessig. 2001. Electronic “quality control” (EQC): is it just for unit use devices? Clin. Chim. Acta 307: 95 99. [PubMed]
13. Ehrmeyer, S. S.,, and R. H. Laessig. 1995. Regulatory requirements (CLIA ’88, JCAHO, CAP) for decentralized testing. Am. J. Clin. Pathol. 104: S40 S49. [PubMed]
14. Faal, M.,, N. Naidoo,, D. K. Glencross,, W. D. Venter,, and R. Osih. 2011. Providing immediate CD4 count results at HIV testing improves ART initiation. J. Acquir. Immune Defic. Syndr. 58: e54 e59. [PubMed][CrossRef]
15. Felder, R. A.,, J. Savory,, K. S. Margrey,, J. W. Holman,, and J. C. Boyd. 1995. Development of a robotic near patient testing laboratory. Arch Pathol. Lab. Med. 119: 948 9451. [PubMed]
16. Fineberg, S. E.,, R. M. Bergenstal,, R. M. Bernstein,, L. M. Laffel,, and S. L. Schwartz. 2001. Use of an automated device for alternative site blood glucose monitoring. Diabetes Care 24: 1217 1220. [PubMed]
17. Fitzgerald, P.,, S. W. Goodacre,, E. Cross,, and S. Dixon. 2011. Cost-effectiveness of point-of-care biomarker assessment for suspected myocardial infarction: the randomized assessment of treatment using panel assay of cardiac markers (RATPAC) trial. Acad. Emerg. Med. 18: 488 495. [PubMed][CrossRef]
18. George, S.,, and R. A. Braithwaite. 2002. Use of on-site testing for drugs of abuse. Clin. Chem. 48: 1639 1646. [PubMed]
19. Grieve, R.,, R. Beech,, J. Vincent,, and J. Mazurkiewicz. 1999. Near patient testing in diabetes clinics: appraising the costs and outcomes. Health Technol. Assess. 3: 1 74. [PubMed]
20. Gruszecki, A. C.,, G. Hortin,, J. Lam,, D. Kahler,, D. Smith,, J. Vines,, L. Lancaster,, T. M. Daly,, C. A. Robinson,, and R. W. Hardy. 2003. Utilization, reliability, and clinical impact of point-of-care testing during critical care transport: six years of experience. Clin. Chem. 49: 1017 1019. [PubMed]
21. Hortin, G. 1998. Handbook of Bedside Glucose Testing. AACC Press, Washington, DC.
22. Hortin, G. L. 1997. Managing the forgotten bedside test—occult blood testing. Adv. Admin. Lab. 6: 4 6.
23. Hortin, G. L.,, and A. B. Carter. 2002. Intraoperative parathyroid hormone testing: survey of testing program characteristics. Arch. Pathol. Lab. Med. 126: 1045 1049. [PubMed][CrossRef]
24. Hsiao, A. L.,, K. A. Santucci,, J. Dziura,, and M. D. Baker. 2007. A randomized trial to assess the efficacy of point-of-care testing in decreasing length of stay in a pediatric emergency department. Pediatr. Emerg. Care 23: 457 462. [PubMed][CrossRef]
25. Hsieh, Y. H.,, J. J. Jung,, J. B. Shahan,, H. A. Pollack,, H. S. Hairston,, D. Moring-Parris,, G. D. Kelen,, and R. E. Rothman. 2011. Outcomes and cost analysis of 3 operational models for rapid HIV testing services in an academic inner-city emergency department. Ann. Emerg. Med. 58: S133 S139. [PubMed][CrossRef]
26. Hughes, M. 2002. Market trends in point-of-care testing. Point of Care 1: 84 94.
27. Hurst, J.,, K. Nickel,, and L. H. Hilborne. 1998. Are physicians’ office laboratory results of comparable quality to those produced in other laboratory settings? JAMA 279: 468 471. [PubMed]
28.International Federation of Clinical Chemistry and Laboratory Medicine. 2001. IFCC reference measurement procedure for substance concentration determination of total carbon dioxide in blood, plasma or serum. Clin. Chem. Lab. Med. 39: 283288. [PubMed][CrossRef]
29. Irvin, G. L.,, 3rd, and G. T. Deriso, 3rd. 1994. A new, practical intraoperative parathyroid hormone assay. Am. J. Surg. 168: 466 468. [PubMed]
30. Jani, I. V.,, N. E. Sitoe,, E. R. Alfai,, P. L. Chongo,, J. I. Quevedo,, B. M. Rocha,, J. D. Lehe,, and T. F. Peter. 2011. Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study. Lancet 378: 1572 1579. [PubMed][CrossRef]
31. Johnson, L. R.,, G. Doherty,, T. Lairmore,, J. F. Moley,, L. M. Brunt,, J. Koenig,, and M. G. Scott. 2001. Evaluation of the performance and clinical impact of a rapid intraoperative parathyroid hormone assay in conjunction with preoperative imaging and concise parathyroidectomy. Clin. Chem. 47: 919 925. [PubMed]
32. Jones, B. A.,, P. Bachner,, and P. J. Howanitz. 1993. Bedside glucose monitoring. A College of American Pathologists Q-Probes study of the program characteristics and performance in 605 institutions. Arch. Pathol. Lab. Med. 117: 1080 1087. [PubMed]
33. Jones, B. A.,, and P. J. Howanitz. 1996. Bedside glucose monitoring quality control practices. A College of American Pathologists Q-Probes study of program quality control documentation, program characteristics, and accuracy performance in 544 institutions. Arch. Pathol. Lab. Med. 120: 339 345. [PubMed]
34. Jungheim, K.,, and T. Koschinsky. 2001. Risky delay of hypoglycemia detection by glucose monitoring at the arm. Diabetes Care 24: 1303 1306. [PubMed]
35. Kabra, S.,, and R. Kanungo. 2012. Monitoring quality of HIV testing at point of care facilities in India. Indian J. Med. Microbiol. 30: 129 130. [PubMed][CrossRef]
36. Kagulire, S. C.,, P. Opendi,, P. D. Stamper,, J. L. Nakavuma,, L. A. Mills,, F. Makumbi,, R. H. Gray,, J. P. Shott,, D. Serwadda,, and S. J. Reynolds. 2011. Field evaluation of five rapid diagnostic tests for screening of HIV-1 infections in rural Rakai, Uganda. Int. J. STD AIDS 22: 308 309. [PubMed][CrossRef]
37. Keffer, J. H. 1995. Economic considerations of point-of-care testing. Am. J. Clin. Pathol. 104: S107 S110. [PubMed]
38. Kilgore, M. L.,, S. J. Steindel,, and J. A. Smith. 1999. Continuous quality improvement for point-of-care testing using background monitoring of duplicate specimens. Arch. Pathol. Lab. Med. 123: 824 828. [PubMed][CrossRef]
39. Kilgore, M. L.,, S. J. Steindel,, and J. A. Smith. 1999. Cost analysis for decision support: the case of comparing centralized versus distributed methods for blood gas testing. J. Healthcare Manag. 44: 207 215. [PubMed]
40. Klarkowski, D. B.,, J. M. Wazome,, K. M. Lokuge,, L. Shanks,, C. F. Mills,, and D. P. O'Brien. 2009. The evaluation of a rapid in situ HIV confirmation test in a programme with a high failure rate of the WHO HIV two-test diagnostic algorithm. PLoS One 4: e4351. [PubMed][CrossRef]
41. Kost, G. J. 2001. Preventing medical errors in point-of-care testing: security, validation, safeguards, and connectivity. Arch. Pathol. Lab. Med. 125: 1307 1315. [PubMed][CrossRef]
42. Kost, G. J. 2002. Principles and Practice of Point-of-Care Testing. Lippincott, Philadelphia, PA.
43. Kost, G. J.,, T. H. Nguyen,, and Z. Tang. 2000. Whole-blood glucose and lactate. Trilayer biosensors, drug interference, metabolism, and practice guidelines. Arch. Pathol. Lab. Med. 124: 1128 1134. [PubMed][CrossRef]
44. Kuwa, K.,, T. Nakayama,, T. Hoshino,, and M. Tominaga. 2001. Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clin. Chim. Acta 307: 187 192. [PubMed]
45. Laposata, M. 2001. Point-of-care coagulation testing: stepping gently forward. Clin. Chem. 47: 801 802. [PubMed]
46. Lee-Lewandrowski, E.,, M. Laposata,, K. Eschenbach,, C. Camooso,, D. M. Nathan,, J. E. Godine,, K. Hurxthal,, J. Goff,, and K. Lewandrowski. 1994. Utilization and cost analysis of bedside capillary glucose testing in a large teaching hospital: implications for managing point of care testing. Am. J. Med. 97: 222 230. [PubMed]
47. Lehman, C. M.,, R. C. Blaylock,, D. P. Alexander,, and G. M. Rodgers. 2001. Discontinuation of the bleeding time test without detectable adverse clinical impact. Clin. Chem. 47: 1204 1211. [PubMed]
48. Losina, E.,, I. V. Bassett,, J. Giddy,, S. Chetty,, S. Regan,, R. P. Walensky,, D. Ross,, C. A. Scott,, L. M. Uhler,, J. N. Katz,, H. Holst,, and K. A. Freedberg. 2010. The “ART” of linkage: pre-treatment loss to care after HIV diagnosis at two PEPFAR sites in Durban, South Africa. PLoS One 5: e9538. [PubMed][CrossRef]
49. Loten, C.,, J. Attia,, C. Hullick,, J. Marley,, and P. McElduff. 2010. Point of care troponin decreases time in the emergency department for patients with possible acute coronary syndrome: a randomised controlled trial. Emerg. Med. J. 27: 194 198. [PubMed][CrossRef]
50. McGarraugh, G.,, D. Price,, S. Schwartz,, and R. Weinstein. 2001. Physiological influences on off-finger glucose testing. Diabetes Technol. Ther. 3: 367 376. [PubMed]
51. Meek, R.,, G. Braitberg,, C. Nicolas,, and G. Kwok. 2012. Effect on emergency department efficiency of an accelerated diagnostic pathway for the evaluation of chest pain. Emerg. Med. Australas. 24: 285 293. [PubMed][CrossRef]
52. (Reference deleted.)
53. Nichols, J. H. 2007. Evidence-Based Practice for Point-of-Care Testing. NACB Guideline, Washington, DC.
54. Nichols, J. H. 2003. Quality in point-of-care testing. Expert Rev. Mol. Diagn. 3: 563 572. [PubMed][CrossRef]
55. Parvin, C. A.,, S. F. Lo,, S. M. Deuser,, L. G. Weaver,, L. M. Lewis,, and M. G. Scott. 1996. Impact of point-of-care testing on patients’ length of stay in a large emergency department. Clin. Chem. 42: 711 717. [PubMed]
56. Paxton, A. 2001. Survey says: labs shy on leukoreduction QC. CAP Today 15: 62. [PubMed]
57. Plerhoples, W.,, F. L. Zwemer, Jr.,, and J. Bazarian. 2004. Point of care pregnancy testing provides staff satisfaction but does not change ED length of stay. Am. J. Emerg. Med. 22: 460 464. [PubMed]
58. Price, C. P. 2001. Point of care testing. Br. Med. J. 322: 1285 1288. [PubMed]
59. Price, C. P.,, and J. M. Hicks. 1999. Point-of-Care Testing. AACC Press, Washington, DC.
59a. Price, C. P.,, A. St John,, and L. J. Kricka. 2010. Point-of-Care Testing: Needs, Opportunity, and Innovation, 3rd ed. AACC Press, Washington, DC.
60. Rosen, S.,, and M. P. Fox. 2011. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med. 8: e1001056. [PubMed][CrossRef]
61. Rossi, A. F.,, and D. Khan. 2004. Point of care testing: improving pediatric outcomes. Clin. Biochem. 37: 456 461. [PubMed][CrossRef]
62. Salem, J. K.,, R. R. Jones,, D. B. Sweet,, S. Hasan,, H. Torregosa-Arcay,, and L. Clough. 2011. Improving care in a resident practice for patients with diabetes. J. Grad. Med. Educ. 3: 196 202. [PubMed][CrossRef]
63. Schaden, E.,, O. Kimberger,, P. Kraincuk,, D. M. Baron,, P. G. Metnitz,, and S. Kozek-Langenecker. 2012. Perioperative treatment algorithm for bleeding burn patients reduces allogeneic blood product requirements. Br. J. Anaesth. 109: 376 381. [PubMed][CrossRef]
64. Shott, J. P.,, R. M. Galiwango,, and S. J. Reynolds. 2012. A quality management approach to implementing point-of-care technologies for HIV diagnosis and monitoring in sub-Saharan Africa. J. Trop. Med. article ID 651927, doi: 10.1155/2012/651927.
65. Singer, A. J.,, J. Ardise,, J. Gulla,, and J. Cangro. 2005. Point-of-care testing reduces length of stay in emergency department chest pain patients. Ann. Emerg. Med. 45: 587 591. [PubMed][CrossRef]
66. Sokoll, L. J.,, H. Drew,, and R. Udelsman. 2000. Intraoperative parathyroid hormone analysis: a study of 200 consecutive cases. Clin. Chem. 46: 1662 1668. [PubMed]
67. Steindel, S. J.,, S. Granade,, J. Lee,, G. Avery,, L. M. Clarke,, R. W. Jenny,, and K. M. LaBeau. 2002. Practice patterns of testing waived under the clinical laboratory improvement amendments. Arch. Pathol. Lab. Med. 126: 1471 1479. [PubMed][CrossRef]
68. Steindel, S. J.,, and P. J. Howanitz. 2001. Physician satisfaction and emergency department laboratory test turnaround time. Arch. Pathol. Lab. Med. 125: 863 871. [PubMed][CrossRef]
69. Stott, R. A.,, G. L. Hortin,, T. R. Wilhite,, S. B. Miller,, C. H. Smith,, and M. Landt. 1995. Analytical artifacts in hematocrit measurements by whole-blood chemistry analyzers. Clin. Chem. 41: 306 311. [PubMed]
70. Tamada, J. A.,, S. Garg,, L. Jovanovic,, K. R. Pitzer,, S. Fermi,, and R. O. Potts. 1999. Noninvasive glucose monitoring: comprehensive clinical results. Cygnus Research Team. JAMA 282: 1839 1844. [PubMed]
71. Walensky, R. P.,, B. L. Morris,, W. M. Reichmann,, A. D. Paltiel,, C. Arbelaez,, L. Donnell-Fink,, J. N. Katz,, and E. Losina. 2011. Resource utilization and cost-effectiveness of counselor- vs. provider-based rapid point-of-care HIV screening in the emergency department. PLoS One 6: e25575. [PubMed][CrossRef]
72. Weber, C. F.,, K. Gorlinger,, D. Meininger,, E. Herrmann,, T. Bingold,, A. Moritz,, L. H. Cohn,, and K. Zacharowski. 2012. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology 117: 531 547. [PubMed][CrossRef]
73. Weber, C. F.,, and K. Zacharowski. 2012. Perioperative point of care coagulation testing. Dtsch. Arztebl. Int. 109: 369 375. [PubMed][CrossRef]
74. Weitgasser, R.,, B. Gappmayer,, and M. Pichler. 1999. Newer portable glucose meters: analytical improvement compared with previous generation devices? Clin. Chem. 45: 1821 1825. [PubMed]
75. Whitley, R. J.,, P. J. Santrach,, and D. L. Phillips. 2001. Establishing a quality management system for unit-use testing based on NCCLS proposed guideline (EP18-P). Clin. Chim. Acta 307: 145 149. [PubMed]
76. Wians, F. H.,, J. A. Balko,, R. M. Hsu,, W. Byrd,, and W. H. Snyder. 2000. Intraoperative vs. central laboratory PTH testing during parathyroid surgery. Lab. Med. 31: 616 621.
77. Wilson, D. P.,, C. K. Fairley,, D. Sankar,, H. Williams,, P. Keen,, T. R. Read,, and M. Y. Chen. 2011. Replacement of conventional HIV testing with rapid testing: mathematical modelling to predict the impact on further HIV transmission between men. Sex. Transm. Infect. 87: 588 593. [PubMed][CrossRef]
78. Winkelman, J. W.,, and M. J. Tanasijevic. 2002. Noninvasive testing in the clinical laboratory. Clin. Lab. Med. 22: 547 558. [PubMed]
79. Winkelman, J. W.,, D. R. Wybenga,, and M. J. Tanasijevic. 1994. The fiscal consequences of central vs distributed testing of glucose. Clin. Chem. 40: 1628 1630. [PubMed]

Tables

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Table 25.1

Management challenges of POCT

Citation: Hortin G, Doern C. 2014. Management of Point-of-Care Testing, p 471-487. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch25
Generic image for table
Table 25.2

Goals of management of POCT

Citation: Hortin G, Doern C. 2014. Management of Point-of-Care Testing, p 471-487. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch25
Generic image for table
Table 25.3

Common advantages and disadvantages of POCT versus central laboratory testing

Citation: Hortin G, Doern C. 2014. Management of Point-of-Care Testing, p 471-487. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch25

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