Information Management
 Updated | November 24, 2008

Laboratory Report Requirements In The Medical Record 

Q.  Our hospital information system captures data from our laboratory system and provides the results in several other hardcopy 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?

A. Yes. Laboratory reports are specifically formatted to improve physician readability and to reduce interpretation error.  As information technology advances and allows for more convenience and customization, hospital and laboratory leaders must ensure that the laboratory report read by the end user meets Joint Commission standards and the federal Clinical Laboratory Improvement Amendment regulations. 

The requirements for organizations to integrate the needs of the laboratory into its information management plan are listed in the hospital accreditation standards.  For the 2008 standards version, please reference IM. 01.01.01. EP1 and LD. 04.01.05.EP 5. The first standard requires the hospital to plan and design information management processes to meet internal and external needs, which includes those identified for individual departments and in accordance with accrediting and regulatory bodies. The second requires the hospital to have effective leadership that ensures coordination of its services among departments.

Laboratory representation on medical records development and implementation teams is recommended to ensure hospital decision makers and software vendors are aware of the specific accrediting agency and regulatory requirements for laboratory reporting formats. For laboratory testing designated as non-waived, this includes (but is not limited to) requirements for the following:  name and address of the performing laboratory, patient name, patient ID number, specimen source, specimen collection date and time, reference ranges, units of measure, date and time of reporting, the condition of unsatisfactory specimens, as well as ensuring that reference laboratory results are not revised. 

Note that for laboratory testing designated as waived, the reporting requirements may be less stringent for some of these elements.  Please refer to the respective standards in the hospital and laboratory accreditation manuals for further information.