The Case for Laboratory Developed Procedures

Quality and Positive Impact on Patient Care

Karen L. Kaul, Linda M. Sabatini, Gregory J. Tsongalis, Angela M. Caliendo, Randall J. Olsen, Edward R. Ashwood, Sherri Bale, Robert Benirschke, Dean Carlow, Birgit H. Funke, Wayne W. Grody, Randall T. Hayden, Madhuri Hegde, Elaine Lyon, Kazunori Murata, Melissa Pessin, Richard Press, Richard B. Thomson

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories.

Original languageEnglish (US)
JournalAcademic Pathology
Volume4
DOIs
StatePublished - Jan 1 2017

Fingerprint

Patient Care
Technology
Explosions
Quality Improvement
Medicine
Guidelines
Safety
Costs and Cost Analysis
Mutation

Keywords

  • Clinical Laboratory Improvement Amendments
  • Food and Drug Administration
  • genomics
  • lab-developed procedures
  • lab-developed tests
  • molecular diagnostics
  • next-generation sequencing

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

Kaul, K. L., Sabatini, L. M., Tsongalis, G. J., Caliendo, A. M., Olsen, R. J., Ashwood, E. R., ... Thomson, R. B. (2017). The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care. Academic Pathology, 4. https://doi.org/10.1177/2374289517708309

The Case for Laboratory Developed Procedures : Quality and Positive Impact on Patient Care. / Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard; Thomson, Richard B.

In: Academic Pathology, Vol. 4, 01.01.2017.

Research output: Contribution to journalArticle

Kaul, KL, Sabatini, LM, Tsongalis, GJ, Caliendo, AM, Olsen, RJ, Ashwood, ER, Bale, S, Benirschke, R, Carlow, D, Funke, BH, Grody, WW, Hayden, RT, Hegde, M, Lyon, E, Murata, K, Pessin, M, Press, R & Thomson, RB 2017, 'The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care', Academic Pathology, vol. 4. https://doi.org/10.1177/2374289517708309
Kaul, Karen L. ; Sabatini, Linda M. ; Tsongalis, Gregory J. ; Caliendo, Angela M. ; Olsen, Randall J. ; Ashwood, Edward R. ; Bale, Sherri ; Benirschke, Robert ; Carlow, Dean ; Funke, Birgit H. ; Grody, Wayne W. ; Hayden, Randall T. ; Hegde, Madhuri ; Lyon, Elaine ; Murata, Kazunori ; Pessin, Melissa ; Press, Richard ; Thomson, Richard B. / The Case for Laboratory Developed Procedures : Quality and Positive Impact on Patient Care. In: Academic Pathology. 2017 ; Vol. 4.
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