Point-of-care hematology and coagulation testing in primary, rural emergency, and disaster care scenarios

Corbin M. Curtis, Gerald J Kost, Richard F. Louie, Rebecca J. Sonu, Erika B. Ammirati, Stephanie L. Sumner

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

The purpose of this article was to review current principles and criteria for obtaining Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) waiver, to identify existing point-of-care (POC) coagulation and hematology technologies, and to analyze regulatory challenges regarding CLIA waiver for those and future devices. The CLIA '88 documentation requires tests performed by laboratories with a certificate of waiver to be so simple that the likelihood of erroneous results by the user is negligible or poses no unreasonable risk of harm to the patient if performed incorrectly as determined by the Secretary of Health and Human Services. 'Simple' means that the test uses unprocessed samples, has a direct readout of test results, does not have specifications for user training, and includes instructions for confirmatory testing when advisable. Currently, the CLIA-waived hematology and coagulation POC devices only test for hemoglobin, hematocrit, and prothrombin time/international normalized ratio. The problem with these devices is the lack of multiplexing. Point-of-care coagulation and hematology devices face challenges for obtaining a waiver. These challenges include lack of clinical needs assessment, 'miniaturized' assays that correct for interfering substances, and assays simple enough to be combined in a multiplex platform. Several scenarios demonstrate how POC coagulation or hematology devices can improve crisis care. Industry should perform needs assessment on clinicians and emergency responders to determine which analytes to incorporate on multiplex POC coagulation and hematology devices and produce devices that address confounding factors.

Original languageEnglish (US)
Pages (from-to)140-145
Number of pages6
JournalPoint of Care
Volume11
Issue number2
DOIs
StatePublished - Jun 2012

Fingerprint

Point-of-Care Systems
Emergency Medical Services
Disasters
Hematology
Equipment and Supplies
Needs Assessment
Emergency Responders
Patient Harm
International Normalized Ratio
Prothrombin Time
Hematocrit
Documentation
Health Services
Industry
Hemoglobins
Technology

Keywords

  • accuracy
  • Clinical Laboratory Improvement Amendments of 1988 waiver
  • clinical needs assessment
  • confounding factors
  • Food and Drug Administration

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Point-of-care hematology and coagulation testing in primary, rural emergency, and disaster care scenarios. / Curtis, Corbin M.; Kost, Gerald J; Louie, Richard F.; Sonu, Rebecca J.; Ammirati, Erika B.; Sumner, Stephanie L.

In: Point of Care, Vol. 11, No. 2, 06.2012, p. 140-145.

Research output: Contribution to journalArticle

Curtis, Corbin M. ; Kost, Gerald J ; Louie, Richard F. ; Sonu, Rebecca J. ; Ammirati, Erika B. ; Sumner, Stephanie L. / Point-of-care hematology and coagulation testing in primary, rural emergency, and disaster care scenarios. In: Point of Care. 2012 ; Vol. 11, No. 2. pp. 140-145.
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