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FDA Recommends Use of LOINC Data Standard

Posted 18 May 2015 | By Alexander Gaffney, RAC

FDA Recommends Use of LOINC Data Standard

The US Food and Drug Administration (FDA) is recommending the use of an existing data exchange standard for nearly all pharmaceutical and biological submissions.


The agency, through its Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), has decided to adopt the Logical Observation Identifiers Names and Codes (LOINC) as "part of a larger FDA effort to align the use of data standards for clinical research with ongoing nationwide health information technology initiatives," FDA wrote in a Federal Register announcement on 14 May 2015.

The LOINC standard is essentially a communication standard by which information—specifically tests, measurements and observations—can be shared between different healthcare entities like care facilities and laboratories.

The universal codes allow other healthcare systems to "understand" the data coming out of clinical trials, thereby allowing the data to be properly filed and understood by clinicians.

"The purpose of LOINC is to facilitate the exchange and pooling of clinical data for clinical care, outcomes management, and research," FDA explains in the Federal Register.

There are actually two components of the LOINC: one for laboratory results, and another for clinical results.

According to FDA:

"The laboratory portion of the LOINC database contains the categories of chemistry, hematology, serology, microbiology (including parasitology and virology), toxicology, and more.

The clinical portion of the LOINC database includes entries for vital signs, hemodynamics, intake/output, EKG, obstetric ultrasound, cardiac echo, urologic imaging, gastroendoscopic procedures, and selected survey instruments."

Recommended Use

The agency said it will now ask that any entity submitting data to CDER or CBER "provide LOINC codes for laboratory test data in investigational studies provided in regulatory submissions," including clinical trial applications and applications for approval, "when those LOINC codes are available."

FDA said it supports the broader use of the LOINC code for three reasons:

  1. LOINC is widely used among clinical laboratories
  2. LOINC-coded lab data make the information easier to understand and analyze
  3. The currently supported exchange standard for laboratory test results in clinical trials, the Study Data Tabulation Model, already supports the exchange of LOINC codes.

However, given the challenges associated with the "high level of granularity inherent in LOINC," FDA said it is also accepting feedback on its recommendation in the hopes of better facilitating the coding process.


Electronic Study Data Submission; Data Standards; Support for the Logical Observation Identifiers Names and Codes

Categories: Regulatory News

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