Version 2.0
Johns Hopkins Medicine
Policy Number
ADM013
Pathology Volume II - General Policy Manual
Documents and Records
Effective Date
04/24/2015
Approval Date
N/A
Subject
Document Management
Page
1 of 6
Supercedes
07/19/2013
Keywords: Policies, procedure manual, technical procedures, Quality Management Documents, Document Control, HPO
Table of Contents
I.
PRINCIPLE/PURPOSE
II.
RESPONSIBILITIES
III.
DEFINITIONS
IV.
PROCESS
V.
SUMMARY/CONCLUSION
VI.
SUPPORTING DOCUMENTATION
VII. REFERENCES
VIII. SIGNATURES
Appendix A: CLIA Director Approval Form
Appendix B: DOCUMENT TEMPLATES
Appendix C: Obtaining an Electronic Signature (HPO)
Appendix D: SIGNATURE PAGE TEMPLATE
Appendix E: DOCUMENT CONTROL LOG
Appendix F: CLIA Director Signature Form (Non- HPO Technical SOPs)
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I. PRINCIPLE/PURPOSE
The purpose of this policy is to provide guidelines on managing document control within the clinical laboratory.
This policy is designed to ensure that:
•
All laboratory procedures/policies and related documents are generated in accordance with the laboratory's quality
management system, federal regulations and accreditation requirements.
•
New documents and substantial changes to these documents are controlled and handled appropriately.
Document management applies to all policies, procedures, forms, work/job aids and quality management documentation within
the path of workflow.
II. RESPONSIBILITIES
It is the responsibility of the CLIA Laboratory Director to review and approve all technical policies and procedures that are
new and those that already exist but have undergone substantial changes. All documents must be approved and reviewed
before they can be implemented.
It is the responsibility of the laboratory area manager/supervisor to ensure that:
•
•
•
•
•
•
All copies of polices and procedures are current and accessible
All personnel have read the documents relevant to their job activities and ensure evidence of said review
All new technical policies/procedures have been authorized and signed by the CLIA Laboratory Director before
implementation
All policies and procedures are reviewed at least every 2 years by the laboratory director or designee. More frequent
reviews may be determined / defined by the laboratory section.
Any changes to a document are made by authorized personnel who are listed on a delegation document.
Any changes to a document are dated and signed.
Version 2.0
Johns Hopkins Medicine
Policy Number
ADM013
Pathology Volume II - General Policy Manual
Documents and Records
Effective Date
04/24/2015
Approval Date
N/A
Subject
Page
Document Management
•
•
Supercedes
2 of 6
07/19/2013
Discontinued polices and procedures are retained in a separate file for at least 2 years after the date discontinued. A longer
retention time may be determined / defined by the laboratory section.
All electronic and paper versions of current procedures are available to laboratory personnel at all times.
III. DEFINITIONS
Document Elements
Elements
Description
Authorized
A document has been authorized if it has been approved by someone with the proper
authority. A signature and date (mm/dd/yy) is evidence.
Available
A document is available if it is reasonably accessible by all individuals who are likely to need
access to the document.
Archived
Archived documents are the older versions of the master document that are retrievable
from a file or from some other source. The records are retained as defined by accreditation
requirements.
When a newer version of a document is the master document, the previous version is retired
and archived noting the retirement date.
Current
Management
Review
Staff Review
A document is current if it is in use and there is no more recent, authorized version of
the document. A document should still be considered current if a newer version is in
development, but has not yet been authorized and made available to staff.
A document has undergone review by an authorized knowledgeable designee at least within
the past 24 months.
A procedure document has been reviewed by personnel when it was placed in service or most
recently updated (whichever comes later).
Document Types
Type
Description
Forms
A document that is used to record results related to the performance of laboratory activities.
A paper or electronic form used to record some observation (eg. results of QC testing). A
form must contain some information itself, above and beyond the information that is to be
recorded. The form should be designed/formatted to instruct the user on how to capture entry
of required data, information or results.
Policy
A basic set of principles or guidelines that indicates an organization’s intentions or
commitments, for example, a written statement that critical laboratory results should be called
within 60 minutes.
Procedure (SOP)
A document that provides detailed step-by-step instructions for an individual to follow to
correctly perform an activity or step in a larger process, for example, step-by-step instructions
for performing ABO identification in the transfusion service or quality control of media in the
microbiology section of the laboratory.
Version 2.0
Johns Hopkins Medicine
Policy Number
ADM013
Pathology Volume II - General Policy Manual
Documents and Records
Effective Date
04/24/2015
Approval Date
N/A
Subject
Page
Document Management
Work /Job Aids
Supercedes
3 of 6
07/19/2013
A summary or part of an approved procedure that is immediately available in close proximity
to where the procedure is to be performed. A chart at a laboratory bench showing media
set up for different microbiology specimens would be considered a work aid if the chart
summarized parts of one or more procedures. The work aid must be controlled and contain
the title and version of the related procedure.
Operational Definitions
New Policy / Procedure
Any new policy or procedure that results in an initial
validation of the test system (i.e..: new methodology,
instrumentation, reference ranges). The Laboratory
Director designee must document review of the procedure
prior to the CLIA Laboratory Director's approval.
A new procedure does not include renaming, renumbering
or reformatting an existing procedure.
Substantial Change
A substantial change is defined as any changes to a policy
or procedure that results in a re-validation of the test
system (i.e..: changes in methodology, instrumentation,
reference ranges). The Laboratory Director designee
must document review of the changed procedure prior to
the CLIA Laboratory Director's approval.
A change that does not impact the test system, such as
correction of clerical errors or addition of new references
to the procedure, is not considered a substantial change.
Test System
The process that includes pre-analytic, analytic, and postanalytic steps used to produce a test result or set of results.
A test system may be manual, automated, multi-channel
or single use and can include reagents, components,
equipment or instruments required to produce results. A
test system may encompass multiple identical analyzers or
devices. Different test systems may be used for the same
analyte.
Technical Policy / Procedure
Any laboratory policy or procedure that impacts the
test system (pre-analytic, analytic, post-analytic).
This includes specimen collection procedures and LIS
procedures that impact the reporting of results.
Version 2.0
Johns Hopkins Medicine
Policy Number
ADM013
Pathology Volume II - General Policy Manual
Documents and Records
Effective Date
04/24/2015
Approval Date
N/A
Subject
Page
Document Management
Non Technical Policy / Procedure
Supercedes
4 of 6
07/19/2013
Any laboratory policy / procedure that does not impact the
test system. Includes, but not limited to:
•
•
•
•
•
Hospital wide administrative policies authorized
outside the laboratory
Safety / environmental procedures
Human Resource procedures
LIS procedures related to computer facility, system
maintenance, system security
Legal / Regulatory
IV. PROCESS
A.
Procedure Manual
A complete procedure manual must be readily accessible to all laboratory personnel at the workbench or in the work area.
1.
2.
3.
All documents must be current
All procedures are written in a format that includes the elements required by CLIA and CAP, as applicable to the test
procedure. See Appendix B
Laboratory personnel must read the procedures relevant to their job
a. The laboratory must maintain records that document laboratory personnel have read new and revised procedures.
Laboratory procedures may be in either paper or electronic format, as long as the most current procedures are readily
available to all staff in the locations where staff perform their assigned job duties. In the event electronic versions are
unavailable or inaccessible, the laboratory must maintain back-up copies. These copies may be paper copies or electronic
copies on other media. CDs or flash drives are examples of acceptable backup copies if they are current and can be readily
accessed on designated computers.
B.
CLIA Laboratory Director Review and Approval
The Laboratory Director (CLIA Laboratory Director) reviews and approves all new technical procedures, as well as
substantial changes to existing technical procedures, before implementation. The Laboratory Director's signature and date of
authorization must appear before implementation of a new procedure or a substantial change in a procedure.
1.
2.
See HPO Management Policy (ADM002) for electronic management of Pathology policies and procedures residing on the
Hopkins Policy and Document Library.
For manual review and signature of technical policies and procedures, the following steps are followed:
a. A document is created and / or substantial changes are added
b. CLIA Director Approval Form is completed. See Appendix A
i.
Document author signs form
ii. Manager/supervisor signs and dates form to acknowledge approval of document content
iii. Division Laboratory Director signs and dates form to acknowledge approval of document content
c. The document and a completed, signed approval form are then delivered to the CLIA Laboratory Director for final
signature.
a. If the Laboratory Director reviews and signs the document electronically, a note can be placed on the CLIA
Director Approval Form indicating the document has been signed.
Version 2.0
Johns Hopkins Medicine
Policy Number
ADM013
Pathology Volume II - General Policy Manual
Documents and Records
Effective Date
04/24/2015
Approval Date
N/A
Subject
Document Management
d.
C.
Page
Supercedes
5 of 6
07/19/2013
An official signed copy of the form is maintained in the laboratory.
New CLIA Director Review and Approval
Whenever there is a change in laboratory directorship, the new CLIA director reviews and approves current technical
laboratory policies and procedures. There must be clear documentation that the process has been started soon after the
change of directorship and completed over a reasonable amount of time. The format of such documentation is at the
discretion of the laboratory director, however it must include:
1.
2.
Itemization of the documents reviewed and approved
Laboratory Director signatures with dates. The signature can be manual or electronic, but must be associated with each
procedure. See Appendix F for an example of a form that can be used to document manual review and approval of
technical procedures by the CLIA Lab Director.
D.
Regularly Scheduled Document Review
All technical policies and procedures are required to be reviewed at least every two years by the Laboratory Director or
designee. (Individual laboratories may require a shorter review period).The designee is identified in writing and may be the
technical laboratory director, laboratory manager or any staff qualified as a technical or general supervisor as defined by
CLIA. Documentation of the biennial review is evidenced as a signature and date (mm/dd/yy) on the document. Electronic
signature and date is also acceptable.
If a technical policy or procedure requires substantial revisions as a result of the review, it must be sent to the CLIA
Laboratory Director for review and approval prior to implementation.
E.
Signatures
Approval and review signatures, with dates, are documented either manually or electronically in the signature section of the
document.
See HPO Management Policy (ADM002) or Appendix C for the Electronic Signature process in HPO.
See Appendix D for a manual Signature template.
If manual signatures are used, an official signed copy is maintained on file in the laboratory.
F.
Retiring Documents
Retired/Discontinued procedures must be retained in a separate file for a minimum of 2 years after the date of
discontinuation. When a procedure is discontinued, a paper or electronic copy is maintained for at least 2 years, recording
initial date of use, and retirement date. A longer retention time may be determined / defined by the laboratory section.
Version 2.0
Johns Hopkins Medicine
Policy Number
ADM013
Pathology Volume II - General Policy Manual
Documents and Records
Effective Date
04/24/2015
Approval Date
N/A
Subject
Page
Document Management
Supercedes
6 of 6
07/19/2013
V. SUMMARY/CONCLUSION
The laboratory must have a document management process in place to ensure that all documents in use are written in the
approved formats, reflect the current version, and are reviewed and approved by the appropriate individual(s) in a timely
manner.
A document management process is vital for ensuring that staff access and use only the most current versions of documents,
and that everyone is following the same process and procedure instructions. This type of standardization can greatly reduce or
eliminate performance variations that can affect the quality of laboratory services.
VI. SUPPORTING DOCUMENTATION
Pathology HPO Management Policy (ADM002)
VII. REFERENCES
Valenstein et al, Document Control, Archives Pathology Lab Medicine - Vol 133, June 2009; www.archivesofpathology.org/
doi/pdf/10.1043/1543-2165-133.6.942
Clinical and Laboratory Standards Institute (CLSI) Quality Management System: Development and Management of Laboratory
Documents; Approved Guideline - 6th Edition. CLSI document, QMS02-A6 (ISBN1-56238-870-3). CLSI, 940 West Valley
Road, Suite 1400, Wayne, PA 19087, 2013.
College of American Pathologist (CAP), Laboratory General checklist, 4/21/2014. Team Leader Assessment of Director &
Quality checklist, 4/21/2014.
College of American Pathologist, Q-Probe 2008, Document Control
VIII. SIGNATURES
Approved/Reviewed by Laboratory Director or
Designee
Date
Brooks Jackson, MD
12/28/2011
Barbara Parsons, MT(ASCP)
07/31/2012
Barbara Parsons, MT(ASCP)
04/24/2015
Official signed copy maintained by the Section Editor
Electronic Signature(s)
Date
Barbara Parsons
Assistant Director, Quality Management
04/24/2015
Michael Borowitz
04/24/2015