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.
Subpart K--Quality System for Nonwaived Testing
(a)
Must establish/maintain policies/procedures to implement and monitor quality systems for all phases of testing processes.
(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.
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.
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.
Subpart J--Facility Administration for Nonwaived Testing
(a)(2)Standard: Retention requirements. Test procedures.
Typically 2 years.
Blood Bank/Transfusion Service 5 years

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

13. AABB Requirements Taken From: Standards for Blood Banks and Transfusion Services, 28th Edition, 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 Requirements Taken From: Standards for Blood Banks and Transfusion Services, 28th Edition, 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 Requirements From: 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 Requirements From: 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 Steps Document Sections (See Template)
Purpose/Principle/ Policy
Responsibility
Materials/Equipment
Attachments/Job Aids/Appendices
Procedure
Interpretation/ Reporting Results
References
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

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

37. Thank You!
Questions?