Evidence map›Paper›PMID 28815200›Full record

ArticleAcademic pathology

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 and 8 more

Abstract read
In one paragraph

Article in Academic pathology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. What Every Clinical Virologist Should Know About The VALID Act On Behalf of the Pan-American Society for Clinical Virology Clinical Practice Com.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2021
    Review
  7. Article
  8. Regulation of Laboratory-Developed Tests.American journal of clinical pathology · 2019
    Review
  9. A Path to Better-Quality mHealth Apps.JMIR mHealth and uHealth · 2018
    Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Karen L KaulDepartment of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA.
Linda M SabatiniDepartment of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA.
Gregory J TsongalisLaboratory for Clinical Genomics and Advanced Technology, Department of Pathology, Dartmouth Hitchcock Medical Center and Norris Cotton Cancer Center, Lebanon, NH, USA.
Angela M CaliendoDepartment of Medicine, Alpert Medical School of Brown University, Providence, RI, USA.
Randall J OlsenDepartment of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, TX, USA.
Edward R AshwoodGeneDx, Gaithersburg, MD, USA.
Sherri BaleDepartment of Pathology, University of Colorado, Aurora, CO, USA.
Robert BenirschkeDepartment of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA.
Dean CarlowDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Birgit H FunkeLaboratory for Molecular Medicine, Massachusetts General Hospital, Boston, MA, USA.
Wayne W GrodyDepartments of Pathology and Laboratory Medicine, Pediatrics and Human Genetics, UCLA School of Medicine, Los Angeles, CA, USA.
Randall T HaydenDepartment of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.
Madhuri HegdeDepartment of Human Genetics, Emory University School of Medicine, Atlanta, GA, USA.
Elaine LyonPathology Department, University of Utah School of Medicine/ARUP Laboratories, Salt Lake City, UT, USA.
Kazunori MurataDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0002-5921-4201
Melissa PessinDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Richard D PressDepartment of Pathology and Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.
Richard B ThomsonDepartment of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA.

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
NCI NIH HHS P30 CA023108
6 · The paper itself

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.

Indexed as

Clinical Laboratory Improvement AmendmentsFood and Drug Administrationgenomicslab-developed procedureslab-developed testsmolecular diagnosticsnext-generation sequencing

Identifiers

PMID28815200
PMCPMC5528950

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.