May 14, 2021
Malvern, PA—The Clinical and Laboratory Standards Institute (CLSI) has published the first edition of QMS26—Managing Laboratory Records.
QMS26 is intended to help laboratories meet quality management system requirements for the records portion of quality system essential documents and records management. It presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records.
QMS26 also includes helpful appendixes with examples of a:
- Records retention schedule
- Records storage facility contract
- Records access request form
Karen Heaton, MLT(CMLTA), chairholder of QMS26 said, “Although much has been written about document management, little has been published about laboratory record management, other than the need for a records retention schedule. This new guideline presents the elements of a laboratory records management program that progresses from creating records at the time of doing work, through accessing and maintaining the records, to their final disposition. Suggestions for how to meet regulatory and accreditation requirements for laboratory records and examples of good practices are included.”
- This press release was originally published on the Clinical and Laboratory Standards Institute website