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Medical Record - Laboratory Requirements

Our hospital information system captures data from our laboratory system and provides the results in several other hard copy and electronic formats accessed by our physicians, such as the physician portal, flash reports, remote web access, etc.  Do all these different reports need to conform to the standards surveyed during the biennial laboratory survey?

Any examples are for illustrative purposes only.

In respect to laboratory electronic health records (EHR), the determination of whether a hospital information system is considered an agent of the laboratory to deliver laboratory reports to the authorized user remains unchallenged in practice. The Joint Commission's longstanding position is that the laboratory, an integrated and essential service within a hospital, has an obligation to ensure the laboratory report, whether hardcopy or electronic, appears in the organization's patient medical record in the intended format and with all required elements. To ensure patient safety and correct interpretation by the end user, it is our further opinion that all alternate distribution versions of the laboratory report (such as portals) derived from the data in the medical record also appear to the end user in the intended format and with all required elements, even if these alternate versions are not considered a part of the patient's permanent medical record.

Other supporting clinical applications in the patient record that may extract, manipulate and redisplay laboratory results in other formats and that do not represent the official or an alternate distribution version of the laboratory report in the record are not subject to the CLIA requirements. Examples include physician notes, wishbone diagrams to support decision making, and nursing flow sheets, all of which may readily integrate laboratory report data for various purposes and in which requiring the presence of all the CLIA required fields may be limiting to innovation and functionality. As such, these supporting clinical applications are not required to contain all of the required elements of the official or alternate distribution versions of the laboratory report. However, each supporting clinical application should be assessed by the organization for inclusion of any and all fields necessary to ensure clarity and proper interpretation by the end user. This assessment should include review by representatives from both the laboratory and the intended end users. At a minimum, it is recommended that the analyte' s name and units of measure always be included with the discrete laboratory result(s), either individually or in title for aggregated data. The date and time of collection may also be necessary in a majority of uses. The use of hyperlinks and hover capabilities to connect the extracted data to the original source laboratory report is strongly encouraged. And lastly, healthcare professionals and software developers must consider the implications associated with corrected laboratory reports and how to manage their effect on all supporting clinical applications that rely upon the original and corrected laboratory results.

As the area of information technology is rapidly changing, please note that this interpretation could change in the future based upon updated regulations, case examples, and other pertinent developments associated with the implementation of the electronic medical record in a healthcare organization.
Manual: Hospital and Hospital Clinics
Chapter: Record of Care Treatment and Services RC
Last reviewed by Standards Interpretation: May 05, 2022 Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: April 11, 2016 This Standards FAQ was first published on this date.
This page was last updated on May 05, 2022 with update notes of: Review only, FAQ is current Types of changes and an explanation of change type: Editorial changes only: Format changes only. No changes to content. | Review only, FAQ is current: Periodic review completed, no changes to content. | Reflects new or updated requirements: Changes represent new or revised requirements.
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