1. Document Control DAP Quality Conference May 12, 2008 Debbie Penn

2. Why Document? Documenting policies, processes, and procedures communicates how to do a quality job to all workers.

3. Patient Safety - def “The prevention and mitigation of unsafe acts within the health-care system. Strategies for improving patient safety include:  Creating a culture that supports the identification and reporting of unsafe acts;  Effective measurement of patient injuries and other relevant outcome indicators; and  Tools for developing or adapting structures and processes to reduce reliance on individual vigilance.” Definition: Canadian Council on Health Services Accreditation (CCHSA) 2003

4. Why Document Control? Controlling documents ensures that workers access and use only the most current versions of documents.

5. Do you know where all of your important documents are located?

6. ISO 15189 4.3 Document Control 4.3.1 The laboratory shall define, document and maintain procedures to control all documents and information that form its quality documentation. A copy of each of the controlled documents shall be archived for later reference and the laboratory director shall define the retention period. 4.3.2 Procedures shall be adopted to ensure that a) All documents issued to laboratory personnel as part of the quality management system are reviewed and approved by authorized personnel prior to issue b) A list, also referred to as a document control log, identifying the current valid revisions and their distribution is maintained c) Only current authorized versions of appropriate documents are available for active use at relevant locations d) Documents are periodically reviewed, revised when necessary, and approved by authorized personnel, e) Invalid or obsolete documents are promptly removed from all points of use, or otherwise assured against inadvertent use, f) Retained or archived superseded documents are appropriately identified to prevent their inadvertent use, g) If the laboratory’s documentation control system allows for the amendment of documents by hand pending the re-issue of documents, the procedures and authorities for such amendments are defined, while amendments are clearly marked, initialed and dated, and a revised document is formally re-issued as soon as practicable, and h) Procedures are established to describe how changes to documents maintained in computerized systems are to be made and controlled 4.3.3 All documents relevant to the quality management system shall be uniquely identified, to include a) Title, b) Edition or current revision date, or revision number, or all these, c) Number of pages (where applicable), d) Authority for issue, and e) Source identification.

7. Lab Standards: DAP X2.0 Procedures and processes are documented, current, accurate, and controlled. x2.1 The laboratory uses documentation to ensure consistency of analysis x2.2 Documentation contains all the relevant material necessary to perform the procedure x2.3 The laboratory defines and maintains procedures to control documents:  Documents are reviewed and approved by the medical leader or designate prior to issue  There is evidence of document review at regular intervals by the medical leader and technical staff  All documents are uniquely identified  Invalid or obsolete documents are promptly removed from all points of use  Copies of master documents are archived  Archival time for master documents is defined by the medical leader  Version identification ensures that the latest approved version is in use  Only current authorized versions of documents are available for active use  A master index of all laboratory documents identifying current version and distribution is in place  Procedures are established to control document changes in computerized systems  There are processes to address the amendments of documents by hand

8. OK? Draft Document No Yes Document Audit Title Document Identifier Responsible Person/Position Authorizer(s) Distribution locations Document Lifecycle Master Index CHM1082SOP

9. Document Lifecycle OK? Draft Document No Yes Document Audit Review Does the process or procedure described work? Approval Who has the authority to place this document into operation?

10. Document Lifecycle OK? Draft Document No Yes Document Audit Master Index: Title Document Identifier Responsible Person/Position Authorizer(s) Distribution locations Version Number Effective Date Next Scheduled Review Date

11. Document Lifecycle OK? Draft Document No Yes Document Audit Audit Controlled (working copies) of documents need to be easily identified, and in the location they are required for work as identified by the Master Index Document Control Rules for Organization

12. Document Lifecycle OK ? New/Modified Document No Yes Document Audit Master Index: Title Document Identifier Responsible Person/Position Authorizer(s) Distribution locations Version Number Effective Date Next Scheduled Review Date -updated

13. Document Lifecycle OK? New/Modified Document No Yes Document Audit Review frequency

14. Document Lifecycle OK? New/Modified Document No Yes Document Audit Who? What? Why? CLSI GP2-A5 Laboratory Documents: Development & Control Appendix R: Sample Document Change Request Form

15. Document Lifecycle OK? New/Modified Document No Yes Document Audit 1. Document Creation & Approval Process 2. Document Distribution Process 3. Document Audit Process 4. Scheduled Document Review Process 6. Document Archive/Destruction Process 5. Document Change Process

16. 3 ways to get this done… Manually  Paper based Semi-Manually  Common network to store/make available documents electronically Document Control Application

17. Where do I start? 1. Create an Identification Number and versioning convention for your documents …and document it…

18. What do I do next? 2. Create a Master Index  Database or spreadsheet  Divide/delegate by process or department if it is too large to manage in a consolidated fashion  Identify responsibility for the Master Index …and document it…

19. What do I do next? 3. Gather your documents  Apply the document identifier  Determine where all copies of the document are in use 4. Create a master document file  Place the master into that file with all of the appropriate authorization and scheduled review signatures  Apply the “Control” mechanism to controlled working copies of the master document

20. Then What? 5. Complete the Master Index  Transfer the document attributes to the Master Index Title Document Identifier Responsible Person/Position Authorizer(s) Distribution locations Version Number Effective Date Next Scheduled Review Date

21. That takes care of documents you already have, now what? 6. Create your document processes  Document Creation, Review & Approval  Document Versioning, Distribution & Audit  Document Change  Document Archive …and document them

22. Create instructions: 7. Write relevant document control procedures including:  How to write a procedure (templates, etc.)  Assign an identification number  Register the document on the Master Index  Identify “Controlled” documents

23. And finally… CLSI GP2-A5 Laboratory Documents: Development & Control Appendix S: Ten Rules for Document Control 8. Develop roles & responsibilities for document users  Write on/make changes to controlled documents?  White out?  Create additional copies beyond those distributed?

24. Document Control Do s & Don’t s DO…  Read  Reference  Vigilant  “Control”  DCR DO NOT…  Write  White out  Photocopy  Print/retain  Release

25. What I have learned along the way… Tips & Warnings

26. Share the “Whys” New Employee Orientation

27. Be prepared to make changes to documents 4401 Controlled Documents 1768 Document Change Requests

28. Draft your document processes, then automate if possible

29. You’re not alone - delegate

30. Berte,L., Nevalainen,D., Quality Systems for the Laboratory, American Society of Clinical Pathologists, Chicago, USA,  2000 Clinical and Laboratory Standards Institute (CLSI), GP2-A5 Laboratory Documents: Development and Control; Approved Guideline-Fifth Edition, CLSI document GP2- A5, Pennsylvania USA,  2006 Canadian Standards Association (CSA), The ISO 15189:2003 Essentials, Mississauga, Ontario, Canada,  2004 Clinical and Laboratory Standards Institute (CLSI), HS1-A2 A Quality Management System Model for Health Care; Approved Guideline-Second Edition, CLSI document GP2-A5, Pennsylvania USA,  2004 References: Thank you Debbie Penn dpenn@bcbio.com