Department of Microbiology Quality Manual / Policy QDRMI03002.11 / Page 1of 4
Section: Documents and Records / Subject Title: Documents andRecords Retentionand DisposalProcedure

Purpose:

To provide retention times guidance for all documents and records of the department.

Responsibility:

All Microbiology staff are responsible for the retention of all laboratory documents and records.

Procedure:

  1. Keep all documents and records for the duration as listed on the DOCUMENTS AND RECORDS RETENTION TIMES chart below.
  1. Each December dispose outdated documents and records as per Hospital Confidentiality Policy.

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DOCUMENTS AND RECORDS RETENTION TIMES

Record Type / Storage Time / Storage Area
Archived Procedure Manuals / 2 years minimum / Electronic copy: T:\Microbio\New Manual\Archive Manual
Electronic work cards / 2 years minimum / Reside in LIS live environment for 2 years and then moved to archive environment by SCC.
Original Requisitions / 2 years minimum *
*10 years for donor testing / Microbiology Store Room for 3 months,IronMountain for the rest of the 2 years and 10 years
Assay Work lists/Day lists/printouts / 2 years minimum*
*10 years for donor testing / Microbiology Store Room for 3 months, IronMountain for the rest of the 2 years and 10 years
VITEK computer record / 2 years minimum / Stored in VITEK computer hard drive
BacT/Alert computer record / 2 years minimum / Stored in BacT/Alert computer hard drive
Referred-out Logs / 2 years minimum / Microbiology Store Room
Referred-out report (including PHL) / 2 years minimum / Microbiology Store Room
Statistics: LCDC reports / 2 years minimum / Microbiology Store Room
Proficiency testing results (QMPLS, CAP, etc) / Hard Copies-5 years minimum
Electronic-5 years minimum / Electronic copies in the LIS. Hard copies <2 years Lab Manual Shelf. Hard copies >2years in the Microbiology Store Room
Proficiency testing reports (QMPLS, CAP, etc) / Hard Copies-10 years minimum / Hard copies <2 years Lab Manual Shelf. Hard copies >2years in the Microbiology Store Room
InstrumentQC Printouts / 2 years minimum / Microbiology Store Room
Instrument Maintenance log / Life of instrument while in service / Lab Manual Shelf.
Instrument Service Record / Life of instrument while in service / Lab Manual Shelf.
Temperature controlled equipment QC / 2 years minimum / Microbiology Store Room
Study and Research Documents / As defined by study protocol
Method Evaluation / Duration of method
Incident Report / 2 years minimum*
*10 years for donor testing / Lab Manual Shelf
IronMountain for donor testing
AssayQC Data / Electronic-2 years minimum*
Hard copies-2 years minimum*
*10 years for donor testing / Electronic copies in the LIS. Hard copies in Microbiology Store Room for 2years
IronMountain for 10 years for donor testing
Quality Control records / Electronic-2 years minimum
Hard copies-2 years minimum / Electronic copies in the LIS. Hard copies in the Microbiology Store Room
Schedule Sheets/Bench Rotation / Hard Copies-7 years minimum
Electronic Summaries of Bench rotations and Christmas list-10 years minimum / Hard Copies in Charge’s Office
Payroll Sheets / Hard Copies-2 years minimum / Hard copies in the Microbiology Store Room.
Viral Load Requisitions / Hard Copies-10 years minimum / Hard Copies of the current 2 years in Viral Load Lab. Hard Copies >2 years stored at IronMountain.
Viral Load Patient Results / Electronic-10 years minimum / Electronic Copies Maintained by the PHL
Viral Load Run Results / Hard Copies-10 years minimum
Electronic-10 years minimum / Hard Copes-Viral Load Lab
Electronic-On Analyzer
Bench Training Checklists / Hard Copies-Duration of employment / Microbiology Charge’s Office
Virology Lab Manual Shelf
Meeting/Committee Minutes (Education, QA, QI, Safety, Virology, General, Technician, etc) / Electronic- 2 years minimum / Electronic-On line
Meeting minutes
SCC Set up Binders and SNUG Binders / As Required / LIS Manager’s Office and in the Microbiology Store Room
Fungal Isolates-Important Isolate Binders / Hard Copies-10 years minimum / Hard Copies in Mycology

Related Documents:

Document name / Document code
Documents and Records Table of Contents / QDRMITOC
Document and Record Maintenance Archival and Retrieval Process / QDRMI03000
Record Review Procedure / QDRMI03001
Document and Record Retrieval Procedure / QDRMI03003

Record of Edited Revisions

Manual Section Name: Documents and RecordsRetentionand DisposalProcedure

Page Number / Item / Date of Revision / Signature of Approval
Annual Review / April 20, 2005 / Dr. T. Mazzulli
Annual Review / April 12, 2006 / Dr. T. Mazzulli
Modified Table / April 12, 2006 / Dr. T. Mazzulli
Annual Review / April 12, 2007 / Dr. T. Mazzulli
Annual Review / June 16, 2008 / Dr. T. Mazzulli
Annual Review / June 16, 2009 / Dr. T. Mazzulli
Annual Review / June 16, 2010 / Dr. T. Mazzulli
Annual Review / May 31, 2011 / Dr. T. Mazzulli
Removed hard copy lab manual archive / May 31, 2012 / Dr. T. Mazzulli
Annual Review / May 31, 2012 / Dr. T. Mazzulli
Updated Michener to IronMountain / May 31, 2012 / Dr. T. Mazzulli
Annual Review / May 31, 2013 / Dr. T. Mazzulli
Updated retention times to 10 years for donor testing / December 18, 2013 / Dr. T. Mazzulli
Updated Iris-Ann’ office to Charge’s office / December 18, 2013 / Dr. T. Mazzulli
Annual Review / June 2, 2014 / Dr. T. Mazzulli

UNIVERSITY HEALTH NETWORK /MOUNT SINAIHOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked against the document (titled as above) on the server prior to use

T:\Microbiology\New Manual\Live Manual\Quality Manual\Documents and Records\Record Retention Procedure QDRMI03002.doc