Difference between revisions of "Journal:Utilizing connectivity and data management systems for effective quality management and regulatory compliance in point-of-care testing"

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|title_full  = Utilizing connectivity and data management systems for effective quality management and regulatory compliance in point-of-care testing
|title_full  = Utilizing connectivity and data management systems for effective quality management<br />and regulatory compliance in point-of-care testing
|journal      = ''Practical Laboratory Medicine''
|journal      = ''Practical Laboratory Medicine''
|authors      = Fung, Angela W.S.
|authors      = Fung, Angela W.S.
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==Abstract==
==Abstract==
Point-of-care testing (POCT) is one of the fastest growing disciplines in [[clinical laboratory]] medicine. POCT [[Medical device|devices]] are widely used in both acute and chronic patient management in the [[hospital]] and [[Physician office laboratory|primary physician office]] settings. As demands for POCT in various healthcare settings increase, managing POCT testing quality and [[regulatory compliance]] are continually challenging. Despite technological advances in applying automatic system checks and built-in [[quality control]] to prevent analytical and operator errors, poor planning for POCT [[Interface (computing)|connectivity]] and [[Informatics (academic field)|informatics]] can limit [[Data sharing|data accessibility]] and [[Information management|management]] efficiency which impedes the utilization of POCT to its full potential. This article will summarize how connectivity and data management systems can improve timely access to POCT results, effective management of POCT programs, and ensure regulatory compliance.
Point-of-care testing (POCT) is one of the fastest growing disciplines in [[clinical laboratory]] medicine. POCT [[Medical device|devices]] are widely used in both acute and chronic patient management in the [[hospital]] and [[Physician office laboratory|primary care physician office]] settings. As demands for POCT in various healthcare settings increase, managing POCT testing quality and [[regulatory compliance]] are continually challenging. Despite technological advances in applying automatic system checks and built-in [[quality control]] to prevent analytical and operator errors, poor planning for POCT [[Interface (computing)|connectivity]] and [[Informatics (academic field)|informatics]] can limit [[Data sharing|data accessibility]] and [[Information management|management]] efficiency which impedes the utilization of POCT to its full potential. This article will summarize how connectivity and data management systems can improve timely access to POCT results, effective management of POCT programs, and ensure regulatory compliance.


'''Keywords''': point-of-care testing, data management, quality assurance, electronic medical record
'''Keywords''': point-of-care testing, data management, quality assurance, electronic medical record


==Introduction==
==Introduction==
 
Point-of-care testing (POCT) refers to near patient testing performed outside the central [[clinical laboratory]] by non-laboratory personnel. POCT provides a faster turnaround time (TAT) for test results, which allows rapid clinical decision making. This has led to early adoption in acute care settings such as operating rooms, intensive care units, and emergency departments within [[hospital]]s. There are increasing interests in expanding POCT to chronic disease management and community health in settings such as [[Physician office laboratory|primary care physician offices]], pharmacies, remote communities, and even in disaster relief initiatives and military operations.<ref name="NIBIBImproving07">{{cite journal |title=Improving healthcare accessibility through point-of-care technologies |journal=Clinical Chemistry |author=National Institute of Biomedical Imaging and Bioengineering; National Heart, Lung, and Blood Institute; National Science Foundation Workshop Faculty et al. |volume=53 |issue=9 |pages=1665-75 |year=2007 |doi=10.1373/clinchem.2006.084707 |pmid=17660275}}</ref><ref name="FüzéryChall19">{{cite journal |title=Challenges of Point-of-Care Testing in Ambulances |journal=Journal of Applied Laboratory Medicine |author=Füzéry, A.K.; Bobyak, J.; Chang, E. et al. |volume=4 |issue=2 |pages=293–95 |year=2019 |doi=10.1373/jalm.2019.029439 |pmid=31639680}}</ref><ref name="AlbasriImpact20">{{cite journal |title=Impact of point-of-care tests in community pharmacies: A systematic review and meta-analysis |journal=BMJ Open |author=Albasri, A.; Van den Bruel, A.; Hayward, G. et al. |volume=10 |issue=5 |at=e034298 |year=2020 |doi=10.1136/bmjopen-2019-034298 |pmid=32414821 |pmc=PMC7232628}}</ref> Rapid TAT is the most commonly cited reason for POCT, yet the clinical utilization of POCT should also ideally be evidence-based, cost-effective, and focus on improving patient outcomes.<ref name="PecoraroPoint14">{{cite journal |title=Point-of-care testing: Where is the evidence? A systematic survey |journal=Clinical Chemistry and Laboratory Medicine |author=Pecoraro, V.; Germagnoli, L.; Banfi, G. |volume=52 |issue=3 |pages=313–24 |year=2014 |doi=10.1515/cclm-2013-0386 |pmid=24038608}}</ref><ref name="FlorkowskiPoint17">{{cite journal |title=Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) - Does it leverage any advantage in clinical decision making? |journal=Critical Reviews in Clinical Laboratory Sciences |author=Florkowski, C.; Don-Wauchope, A.; Gimenez, N. et al. |volume=54 |issue=7–8 |pages=471–94 |year=2017 |doi=10.1080/10408363.2017.1399336 |pmid=29169287}}</ref><ref name="QuinnBarriers16">{{cite journal |title=Barriers to hospital-based clinical adoption of point-of-care testing (POCT): A systematic narrative review |journal=Critical Reviews in Clinical Laboratory Sciences |author=Quinn, A.D.; Dixon, D.; Meenan, B.J. |volume=53 |issue=1 |pages=1–12 |year=2016 |doi=10.3109/10408363.2015.1054984 |pmid=26292075}}</ref> A number of systematic reviews and narrative reviews on evidence-based POCT are ongoing.<ref name="PecoraroPoint14" /><ref name="FlorkowskiPoint17" /><ref name="QuinnBarriers16" /><ref name="HeneghanSelf16">{{cite journal |title=Self-monitoring and self-management of oral anticoagulation |journal=Cochrane Database of Systematic Reviews |author=Heneghan, C.J.; Garcia-Alamino, J.M.; Spencer, E.A. et al. |volume=7 |at=CD003839 |year=2016 |doi=10.1002/14651858.CD003839.pub3 |pmid=27378324}}</ref><ref name="AabenhusBiom14">{{cite journal |title=Biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care |journal=Cochrane Database of Systematic Reviews |author=Aabenhus, R.; Jensen, J.-U.S.; Jørgensen, K.J. et al. |volume=6 |issue=11 |at=CD010130 |year=2014 |doi=10.1002/14651858.CD010130.pub2 |pmid=25374293}}</ref><ref name="SharmaTheClin15">{{cite journal |title=The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: Systematic review and economic evaluation |journal=Health Technology Assessment |author=Sharma, P.; Scotland, G.; Cruickshank, M. et al. |volume=19 |issue=48 |pages=1-172 |year=2015 |doi=10.3310/hta19480 |pmid=26138549 |pmc=PMC4780913}}</ref><ref name="McTaggartDiag14">{{cite journal |title=Diagnostic accuracy of point-of-care tests for detecting albuminuria: A systematic review and meta-analysis |journal=Annals of Internal Medicine |author=McTaggart, M.P.; Newall, R.G.; Hirst, J.A. et al. |volume=160 |issue=8 |pages=550–7 |year=2014 |doi=10.7326/M13-2331 |pmid=24733196}}</ref><ref name="ShivkumarAccur12">{{cite journal |title=Accuracy of rapid and point-of-care screening tests for hepatitis C: A systematic review and meta-analysis |journal=Annals of Internal Medicine |author=Shivkumar, S.; Peeling, R.; Jafari, Y. et al. |volume=157 |issue=8 |pages=558–66 |year=2012 |doi=10.7326/0003-4819-157-8-201210160-00006 |pmid=23070489}}</ref><ref name="Al-AnsaryPoint11">{{cite journal |title=Point-of-care testing for Hb A1c in the management of diabetes: A systematic review and metaanalysis |journal=Clinical Chemistry |author=Al-Ansary, L.; Farmer, A.; Hirst, J. et al. |volume=57 |issue=4 |pages=568–76 |year=2011 |doi=10.1373/clinchem.2010.157586 |pmid=21368238}}</ref><ref name="GialamasPoint10">{{cite journal |title=Point-of-care testing for patients with diabetes, hyperlipidaemia or coagulation disorders in the general practice setting: A systematic review |journal=Family Practice |author=Gialamas, A.; St. John, A.; Laurence, C.O. et al. |volume=27 |issue=1 |pages=17–24 |year=2010 |doi=10.1093/fampra/cmp084 |pmid=19969524}}</ref><ref name="PriceImprov18">{{cite journal |title=Improving the quality of point-of-care testing |journal=Family Practice |author=Price, C.P.; Smith, I.; Van den Bruel, A. |volume=35 |issue=4 |pages=358–64 |year=2018 |doi=10.1093/fampra/cmx120 |pmid=29253125}}</ref>




Revision as of 23:02, 9 November 2020

Full article title Utilizing connectivity and data management systems for effective quality management
and regulatory compliance in point-of-care testing
Journal Practical Laboratory Medicine
Author(s) Fung, Angela W.S.
Author affiliation(s) St. Paul’s Hospital, University of British Columbia
Primary contact Email: afung7 at providencehealth dot bc dot ca
Year published 2020
Volume and issue 22
Page(s) e00187
DOI 10.1016/j.plabm.2020.e00187
ISSN 2352-5517
Distribution license Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Website https://www.sciencedirect.com/science/article/pii/S2352551720301505
Download https://www.sciencedirect.com/science/article/pii/S2352551720301505/pdfft (PDF)
Emblem-important-yellow.svg This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed.

Abstract

Point-of-care testing (POCT) is one of the fastest growing disciplines in clinical laboratory medicine. POCT devices are widely used in both acute and chronic patient management in the hospital and primary care physician office settings. As demands for POCT in various healthcare settings increase, managing POCT testing quality and regulatory compliance are continually challenging. Despite technological advances in applying automatic system checks and built-in quality control to prevent analytical and operator errors, poor planning for POCT connectivity and informatics can limit data accessibility and management efficiency which impedes the utilization of POCT to its full potential. This article will summarize how connectivity and data management systems can improve timely access to POCT results, effective management of POCT programs, and ensure regulatory compliance.

Keywords: point-of-care testing, data management, quality assurance, electronic medical record

Introduction

Point-of-care testing (POCT) refers to near patient testing performed outside the central clinical laboratory by non-laboratory personnel. POCT provides a faster turnaround time (TAT) for test results, which allows rapid clinical decision making. This has led to early adoption in acute care settings such as operating rooms, intensive care units, and emergency departments within hospitals. There are increasing interests in expanding POCT to chronic disease management and community health in settings such as primary care physician offices, pharmacies, remote communities, and even in disaster relief initiatives and military operations.[1][2][3] Rapid TAT is the most commonly cited reason for POCT, yet the clinical utilization of POCT should also ideally be evidence-based, cost-effective, and focus on improving patient outcomes.[4][5][6] A number of systematic reviews and narrative reviews on evidence-based POCT are ongoing.[4][5][6][7][8][9][10][11][12][13][14]


Abbreviations

DMS: data management system

EMR: electronic medical record

HIS: hospital information system

LIS: laboratory information system

POCT: point-of-care testing

TAT: turnaround time

QC: quality control

References

  1. ↑ National Institute of Biomedical Imaging and Bioengineering; National Heart, Lung, and Blood Institute; National Science Foundation Workshop Faculty et al. (2007). "Improving healthcare accessibility through point-of-care technologies". Clinical Chemistry 53 (9): 1665-75. doi:10.1373/clinchem.2006.084707. PMID 17660275. 
  2. ↑ Füzéry, A.K.; Bobyak, J.; Chang, E. et al. (2019). "Challenges of Point-of-Care Testing in Ambulances". Journal of Applied Laboratory Medicine 4 (2): 293–95. doi:10.1373/jalm.2019.029439. PMID 31639680. 
  3. ↑ Albasri, A.; Van den Bruel, A.; Hayward, G. et al. (2020). "Impact of point-of-care tests in community pharmacies: A systematic review and meta-analysis". BMJ Open 10 (5): e034298. doi:10.1136/bmjopen-2019-034298. PMC PMC7232628. PMID 32414821. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7232628. 
  4. ↑ 4.0 4.1 Pecoraro, V.; Germagnoli, L.; Banfi, G. (2014). "Point-of-care testing: Where is the evidence? A systematic survey". Clinical Chemistry and Laboratory Medicine 52 (3): 313–24. doi:10.1515/cclm-2013-0386. PMID 24038608. 
  5. ↑ 5.0 5.1 Florkowski, C.; Don-Wauchope, A.; Gimenez, N. et al. (2017). "Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) - Does it leverage any advantage in clinical decision making?". Critical Reviews in Clinical Laboratory Sciences 54 (7–8): 471–94. doi:10.1080/10408363.2017.1399336. PMID 29169287. 
  6. ↑ 6.0 6.1 Quinn, A.D.; Dixon, D.; Meenan, B.J. (2016). "Barriers to hospital-based clinical adoption of point-of-care testing (POCT): A systematic narrative review". Critical Reviews in Clinical Laboratory Sciences 53 (1): 1–12. doi:10.3109/10408363.2015.1054984. PMID 26292075. 
  7. ↑ Heneghan, C.J.; Garcia-Alamino, J.M.; Spencer, E.A. et al. (2016). "Self-monitoring and self-management of oral anticoagulation". Cochrane Database of Systematic Reviews 7: CD003839. doi:10.1002/14651858.CD003839.pub3. PMID 27378324. 
  8. ↑ Aabenhus, R.; Jensen, J.-U.S.; Jørgensen, K.J. et al. (2014). "Biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care". Cochrane Database of Systematic Reviews 6 (11): CD010130. doi:10.1002/14651858.CD010130.pub2. PMID 25374293. 
  9. ↑ Sharma, P.; Scotland, G.; Cruickshank, M. et al. (2015). "The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: Systematic review and economic evaluation". Health Technology Assessment 19 (48): 1-172. doi:10.3310/hta19480. PMC PMC4780913. PMID 26138549. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4780913. 
  10. ↑ McTaggart, M.P.; Newall, R.G.; Hirst, J.A. et al. (2014). "Diagnostic accuracy of point-of-care tests for detecting albuminuria: A systematic review and meta-analysis". Annals of Internal Medicine 160 (8): 550–7. doi:10.7326/M13-2331. PMID 24733196. 
  11. ↑ Shivkumar, S.; Peeling, R.; Jafari, Y. et al. (2012). "Accuracy of rapid and point-of-care screening tests for hepatitis C: A systematic review and meta-analysis". Annals of Internal Medicine 157 (8): 558–66. doi:10.7326/0003-4819-157-8-201210160-00006. PMID 23070489. 
  12. ↑ Al-Ansary, L.; Farmer, A.; Hirst, J. et al. (2011). "Point-of-care testing for Hb A1c in the management of diabetes: A systematic review and metaanalysis". Clinical Chemistry 57 (4): 568–76. doi:10.1373/clinchem.2010.157586. PMID 21368238. 
  13. ↑ Gialamas, A.; St. John, A.; Laurence, C.O. et al. (2010). "Point-of-care testing for patients with diabetes, hyperlipidaemia or coagulation disorders in the general practice setting: A systematic review". Family Practice 27 (1): 17–24. doi:10.1093/fampra/cmp084. PMID 19969524. 
  14. ↑ Price, C.P.; Smith, I.; Van den Bruel, A. (2018). "Improving the quality of point-of-care testing". Family Practice 35 (4): 358–64. doi:10.1093/fampra/cmx120. PMID 29253125. 

Notes

This presentation is faithful to the original, with only a few minor changes to presentation. Grammar was cleaned up for smoother reading. In some cases important information was missing from the references, and that information was added.

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