Document Management Control

MediaLab and Inspection Proof

The Laboratory of Pathology migrated document management control to MediaLab in CY2020. All policies, procedures and forms are implemented, revised and reviewed using the MediaLab platform which tracks required document management control requirements.  This document control modality provides an automated, centralized platform for all of LP's document approvals, workflows, edits, sign-offs, and audits.

For all new policies, procedures or forms, and for any significant revisions to any policies or procedures, the author must notify the Medical Director in writing the reason for the revision and the page where the revision has been made.

Document Control Forms

Suggested Document Control Form

Document Control

Document control is the responsibility of each clinical section; however, certain common rules apply to document management. The NIH has rules regarding records management https://oma.od.nih.gov/DMS/Pages/Records-Management.aspx; NIH record retention policy https://oma.od.nih.gov/DMS/Pages/Records-Management-Record-Keeping.aspx; and Federal statutes (36 CFR 1220, 1222, 1228, 1230) take precedence over any Laboratory of Pathology (LP) policy or other regulatory standards established by agencies such as the CAP and JCAHO.

Standard Operating Procedures

A complete technical policies and procedures manual must be available in each work area. For clinical laboratories, this includes ensuring staff have access to the General LP Policy Manual and the section's technical procedure manual(s). In accordance with CAP standard COM.10300, all personnel must be able to demonstrate knowledge about the contents of procedure manuals relevant to the scope of their testing activities. All LP staff are required to review policy and procedure manuals initially upon hire and if there are significant procedure or policy revisions. Annual review and sign-off in MediaLab by testing personnel is not required to satisfy the CAP standard of staff knowledge of procedures. Annual proficiency with SOPs/policies is accomplished during the annual competency assessment for each staff as determined by the Medical Director or designee. 

SOP Review and Revision

• In general, any revision to policies, procedures, forms or checklists enclosed within the policy manual must be approved by the Medical Director, or designee, if the document is section-specific. However, certain CAP rules apply for new or significantly revised policies.

• CAP standard COM.10200 requires that the Medical Director must review and approve new policies and procedures, as well as substantial changes to existing documents, before implementation. The director also reviews and approves all substantial changes to the specimen collection/handling procedure manual before implementation.

• Minor revisions to documents specific to each clinical section will be approved and adopted by the section designee. Refer to the Delegation of Authority for the list of designated authorized approving medical officers.

• In accordance with CAP Standard COM.10100, the Medical Director or designee (refer to Delegation of Authority) must review all policies and procedures every two (2) years. Review must be completed at the individual level of each procedure, and a single signature on the manual's cover page is not sufficient. The reviewed may use a listing of the named policies and procedures, such as the index page with all titles, to document biennial review.

If changes are made, please refer to the distribution list to ensure that all manuals reflect the revised version.

• Changes to documents should be accompanied by an explanation for the revision, unless revisions are made only to update contact information not critically relevant to the content.

• Obsolete, or revised, versions of policies, procedures, or forms will be kept on file for at least two (2) years; or for the life of the equipment if the document relates to technical procedures. When a policy or procedure is discontinued, the obsolete version must have the initial date of use and retirement date documented. 

• All clinical sections will have staff read and sign the review page of revised policies and procedures, attesting that each person has read and understands the contents of this manual specific to their duties.

Notes:

• The use of inserts provided by manufacturers is not acceptable in place of a procedure manual. However, such inserts may be used as part of a procedure description, if the insert accurately and precisely describes the procedure as performed in the laboratory. Any variation from this printed or electronic procedure must be detailed in the procedure manual. In all cases, appropriate reviews must occur.

• A manufacturer's procedure manual for an instrument/reagent system may be acceptable as a component of the overall departmental procedures. Any modification to or deviation from the procedure manual must be clearly documented.

Correction of Laboratory Records

• Staff in the clinical laboratories must ensure that records and any revisions to laboratory records, such as quality control data, temperature logs, and intermediate test results or worksheets, must be legible and indelible. 
• Original erroneous entries should have a single-line strike-through.
• Erasure, whiteout or correction fluid are unacceptable.
• Corrected data, including the identify of the person making the revision and date of revision must be documented and accessible for audit. 
• Note: this policy does not apply to revisions to patient reports, please refer to Error Detection and Revised /Corrected Reports.

KEEPING AND DESTROYING RECORDS

NIH Manual Chapter, “1743- Keeping and Destroying Records” provides instructions for specific record keeping and destruction (a printed copy of the entire policy is available in the Clinical Manager’s Office). This schedule is used in conjunction with the National Archives and Records Administration (NARA) to ensure that necessary and useful records are retained as long as required and reasonable; to weed unnecessary records; that space is not taken by records not needed for current business; and that records with lasting historical, legal or scientific value are preserved. Government records cannot be destroyed, mutilated or removed from government custody without authorization. Destruction or removal of government records other than as authorized in an approved records schedule is a serious offense that could lead to adverse action against the individual. Records valuable enough to be preserved temporarily may be kept at EPL archives or be permanently transferred to the National Archives, as appropriate. Records which are not in active use, but which cannot be destroyed for some time, may be transferred to a Federal Records Center.

Records may be any physical form or characteristic such as paper, microfilm, magnetic tapes, cards, disks, or other material. They may be letters, memoranda, reports or other materials commonly found in office files. They may also be lab notebooks, instrument readings, photographs, sound recordings, motion pictures, maps, books, drawings, databases or in any other form or format. The official records of the NIH are created by or for NIH or received by NIH in the course of doing business.

Certain non-records are excluded, including: blank forms, working papers, drafts, materials used exclusively for reference, stocks of publication (except one), documents for fringe activities (carpool, charitable funds, etc). Non-records should be removed from NIH files as soon as they are no longer needed.

Personal files are those that relate only to an individual’s personal affairs and must be maintained apart from official records.

If you have difficulty finding any type of record in the schedule, contact the IC Records Officer, listed in the yellow pages of the NIH Telephone and Service Directory.

Each Section Chief should ensure that records are removed form active files and disposed of at the times specified in the NIH Records Control Schedule. If the records are subject to the Privacy Act, witnessed disposal is required. If the public interest would be served consult with the NIH Records Management Officer to donate them to the National Archives.