The Basics of Document Control in the Laboratory

1. The Basics of Document Control in the Laboratory Jen Schuler Director of Laboratory Services Fairbanks Memorial Hospital Laboratories

2. Introductions Name and Title Your Experience with Document Control

3. Objectives • Describe how document control has changed over time. • Discuss regulatory requirements as well as some accrediting agency requirements for document control. • Understand the basic requirements for document control in the Laboratory. • Understand the basics of writing a procedure.

4. What is Your Definition of Document Control?

5. Is it really “Document Control”? • Overall organization on how we deal with all documents within our laboratories to ensure they are: • Current • Approved prior to use • Reviewed as required • Correct • Available for end user • With all parts and pieces it really becomes “Document Control Management”

6. Some History • Around 2003, AABB and CAP began adding requirements to ensure laboratories had document control systems and that ALL laboratory documents were subject to document control. (Paxton, Anne. Bedeviled by Documents, Labs Seek Control. CAP Today. July 2009.) • Think back to those old procedures that you run into now and then. How do you see they have changed over time?

7. CLIA Requirements From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1. www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html Subpart K--Quality System for Nonwaived Testing • 493.1200 (a) • Must establish/maintain policies/procedures to implement and monitor quality systems for all phases of testing processes. • 493.1251 (a-e)Standard: Procedure Manual. • Must have manuals for all test/assay/exams performed available to all staff.

8. CLIA Requirements From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1. www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html • Must include: • All pre analytical variables, i.e. patient prep, specimen collection/labeling/processing/rejection, etc. • Prep of all materials, reagents, etc. • Control, calibration and cal ver procedures • Reportable Range/Normal Values/Critical Values • Corrective Action • References • Reporting Results including critical values • Downtime procedures

9. CLIA Requirements From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1. www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html • May use manufacturer’s instructions/operator manuals if meet requirements • Must be approved (dated/signed) by lab director before use (new and changed) • Must maintain copy with date of initial implementation and archive.

10. CLIA Requirements From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1. www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html Subpart J--Facility Administration for Nonwaived Testing • 493.1105 (a)(2)Standard: Retention requirements. Test procedures. • Typically 2 years. • Blood Bank/Transfusion Service 5 years

11. CAP RequirementsFrom: “Laboratory General” and “All Common” Checklists, CAP Accreditation Program, 9/25/12. • GEN.20375 – The Laboratory has a document control system • Policy/procedure current • Staff has read those relevant to job • Authorized by lab director prior to implement • Reviewed biennially by director/designee • Archived are quarantined for 2 years or 5 for transfusion med. • Electronic is OK.

12. CAP RequirementsFrom: “Laboratory General” and “All Common” Checklists, CAP Accreditation Program, 9/25/12. • COM.10200 New Procedure Review • Lab Director review/approve all new and substantial changes before implementation • COM.10300 Knowledge of Procedures • All staff are knowledgeable about the contents of manuals relevant to their scope of practice. This includes changes • COM.10400 New Director Procedure Review • New lab director must review manuals within reasonable period of time.

13. AABB RequirementsTaken From: Standards for Blood Banks and Transfusion Services, 28thEdition, AABB, effective Nov. 1,2012. • Standard 6.1 – Documents. The blood bank or transfusion service shall have a process for document control that includes the following elements: • Master List of documents (policies, processes, procedures, labels and forms) (6.1.1) • Use of standardized format for documents (6.1.2) • Review and approval of new and revised documents before use (6.1.3)

14. AABB RequirementsTaken From: Standards for Blood Banks and Transfusion Services, 28thEdition, AABB, effective Nov. 1, 2012. • Review by authorized individual (minimum every 2 years) (6.1.4) • Use only valid and current documents (6.1.5) • Identification and archival of obsolete documents (6.1.6) • Storage to preserve legibility and protect from accidental or unauthorized access, destruction or modification.

15. COLA RequirementsFrom: Organization section of the COLA Laboratory Accreditation Manual, COLA, June 2012. • ORG 12 R – Does the procedure manual include all the tests offered by the laboratory? • ORG 13 R – Is the procedure manual easily accessible to your personnel? • ORG 15 R – Are all the test procedure reviewed, approved, and signed annually by the lab director?

16. COLA RequirementsFrom: Organization section of the COLA Laboratory Accreditation Manual, COLA, June 2012. • ORG 16 R – ORG 18 R – Does the laboratory director sign and date: • Each new procedure • Any changes • Entire manual if he/she is new director • ORG 19 R – Are procedures dated when they are initially put into use and when they are discontinued? • ORG 20 R – Are discontinued procedures kept for at least 2 years beyond the discontinued date?

17. Why Is Document Control Important and Necessary? • CLIA and our Accrediting Agencies tell us so • Sets expectations • Consistency among staff/everyone on same page • Guidelines for when things don’t go right • Consistent, Quality Patient Care!

18. Who is Responsible? • Ultimately – the Laboratory Director • Typically… • Managers • Supervisors • Section Leads • Consider having bench level staff work on procedures and document control.

19. Do We Have To? • Leaders have probably heard questions such as: • Do we have to follow all these steps? • Can I skip this? • I really need my cheat sheet. • Why can’t we just…? • Having an in depth, clear, concise, and as easy as possible process in place is important • It can be difficult to keep track on paper as it is easy to miss steps. • Make sure you have a point person

20. It’s Where? • It is very important to have the right information at the right place at the right time. • Control of documents will help make sure the errant copies of old procedures do not suddenly appear after 5 years because someone kept a copy in a drawer. • Utilize staff who will use the document to figure out where information needs to go.

21. Resources to Use • CLSI Documents such as: Laboratory Documents: Development and Control; Approved Guideline – 5th Edition; GP2-A5. • Accrediting Agencies • Teleconferences, webinars, etc. • Vendors that offer electronic document control management systems • Specialized procedure writing programs • Colleagues – Do not be afraid to ask!

22. Document Control and Management at FMH Laboratories • Our system was originally developed by management and staff in our Blood Bank/Transfusion Service. • In 2010, we modified our existing lab-wide document control system by expanding the Blood Bank system throughout the rest of the lab. • Change control is a large part of our document management system.

23. Definitions from FMH Labs • Policy – Describes why something happens. A written statement of overall intentions and directions defined by those in the organization and endorsed by management. • Process – Describes the sequence of specific activities that take place across time and identifies the specific organizational units and individuals involved. • Procedure- A set of instructions that describe the stepwise actions to be taken to complete activities identified in processes. • Form – A paper or electronic document on which the results from the performance of a procedure or other information are captured. When the form is completed, it will become a record.

24. Definitions from FMH Labs • Attachment – A document that aids in the process, policy, or procedure and may include important information needed by the reader to make decisions. This may be created or may be from a reference. • Substantial Change(s) – Any change(s) to a policy, procedure, or process that is assessed “High Risk” by the Change Control procedure. • Revision – Any changes to a policy, procedure, or process that is assessed Medium or Low Risk by the Change Control procedure.

25. FMH Change Control(Flow Chart) *Any staff member can submit. *For use for any changes to process, policy, procedure to include forms and attachments.

26. FMH Change Control *Manager reviews, logs, assigns number and passes it on to appropriate person. *Change is discussed as needed and either accepted, rejected or amended. Decision is passed along to submitter.

27. FMH Change Control Designee completes: *The rationale as to why we are implementing *Risk Assessment *Plan for Implementation

28. FMH Change Control Risk Assessment

29. Next Steps • Assign Document Number using Master List of Documents • Create or Revise Document (See Template) • Include Lab Name/location • Title • Document Location • Document number • Related Documents • Approval Information • Revision Information

30. Next StepsDocument Sections (See Template) • Purpose/Principle/ Policy • Responsibility • Materials/Equipment • Attachments/Job Aids/Appendices • Procedure • Interpretation/ Reporting Results • References • Attachments/Job Aids/Appendices • Annual Review • Background • Specimen Requirements • Reagents • Reagent Preparation • Safety • Calculations • QC or Calibration • Maintenance • Limitations • Notes • Definitions • Before You Begin

31. Next Steps Major Changes • New test implementation (see New Test Implementation Checklist) • Complete all validation and method verification studies as indicated

32. Next Steps • Have staff review document (SOP Validation Checklists) • Designee will check for regulatory compliance • Make edits if indicated • Get required approval • Lab Director for New and Substantially Changed documents • Medical Director and supervisor/manager assigned to area

33. Next Steps • Train Staff • Staff review new/revised SOP (SOP Change and Review Form) • Implement SOP • Archive as needed • Don’t forget to update the Master List of Documents • “Records Management Checklist” • Annual Review as required.

34. Now It Is Your Turn • Volunteer Needed...

35. Details • Change Request submitted to create an SOP for Making a Peanut Butter and Jelly Sandwich for lunch. • Change Request is amended because we realize we do not have a manual for making lunch. • New Manual to be created with title “Home Lunch” • Procedure number assigned HL.001.00.

36. Writing the Procedure as a Group Volunteer to make a sandwich Use template to write as a group

37. Thank You! Questions?