title: Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel.
abstract: OBJECTIVE
  Developing electronic clinical data into a common data model posed substantial challenges unique from those encountered with administrative data. We present here the design, implementation, and use of the Mini-Sentinel Distributed Database laboratory results table (LRT).
  
  
  METHODS
  We developed the LRT and guided Mini-Sentinel data partners (DPs) in populating it from their source data. Data sources included electronic health records and internal and contracted clinical laboratory systems databases. We employed the Logical Observation Identifiers, Names, and Codes (LOINC®) results reporting standards. We evaluated transformed results data using data checks and an iterative, ongoing characterization and harmonization process.
  
  
  RESULTS
  Key LRT variables included test name, subcategory, specimen source, LOINC, patient location, specimen date and time, result unit, and unique person identifier. Selected blood and urine chemistry, hematology, coagulation, and influenza tests were included. Twelve DPs with outpatient test results participated; four also contributed inpatient test results. As of September 2013, the LRT included 385,516,239 laboratory test results; data are refreshed at least quarterly. LOINC availability and use varied across DP. Multiple data quality and content issues were identified and addressed.
  
  
  CONCLUSIONS
  Developing the LRT brought together disparate data sources with no common coding structure. Clinical laboratory test results obtained during routine healthcare delivery are neither uniformly coded nor documented in a standardized manner. Applying a systematic approach with data harmonization efforts and ongoing oversight and management is necessary for a clinical laboratory results data table to remain valid and useful.
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA; University of Colorado Skaggs, School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
authors.forename: Marsha A
authors.initials: MA
authors.lastname: Raebel
authors.forename: Kevin
authors.initials: K
authors.lastname: Haynes
authors.forename: Tiffany S
authors.initials: TS
authors.lastname: Woodworth
authors.forename: Gwyn
authors.initials: G
authors.lastname: Saylor
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Cavagnaro
authors.forename: Kara O
authors.initials: KO
authors.lastname: Coughlin
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.forename: Mark G
authors.initials: MG
authors.lastname: Weiner
authors.forename: Patrick
authors.initials: P
authors.lastname: Archdeacon
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Brown
mesh_terms: D002984:Clinical Laboratory Information Systems / Q000592:standards* / Q000639:trends; D016208:Databases, Factual / Q000592:standards* / Q000639:trends; D057286:Electronic Health Records / Q000592:standards* / Q000639:trends; D006801:Humans; D010865:Pilot Projects; D018571:Sentinel Surveillance
keywords: administrative database; clinical database; distributed data network; electronic laboratory databases; laboratory test results; pharmacoepidemiology; post-marketing evaluation; safety surveillance