Document Development and Document Control Quality Essentials for Safe Transfusion K. Gagliardi

1. Document Development and Document ControlQuality Essentials for Safe TransfusionK. Gagliardi

2. Overview Introduction and QUEST model Models from Literature Top 20 Questions Related Standards – Requirements Questions we can’t answer Conclusions/Lessons Learned

3. Your questions about Documents

4. What is the QUEST project? A 2 to 3 year research project Funded by the MOH - LTC Developing a quality system model in Transfusion Medicine based on new Health Canada standards Model will provide Ontario TM labs with validated templates Two Ontario locations: Hamilton/Niagara and Ottawa

5. “Total Quality System”

6. Hamilton/Niagara-Current Activities Develop and pilot: Laboratory processes and SOPs System for Document Control Blood administration guidelines Education & training Non-conformance management (MERS-TM) and surveillance Centralized inventory,storage/transport/wastage

7. TOPS-Transfusion Ontario Programs Blood conservation initiative by Ontario MOH – LTC and OBSRG (Ontario Blood System reference Group) QUEST is found under ‘The Programs’ at http://www.transfusionontario.org/ Other programs: ONTraC, Physician Education, Autologous, CIDP study, THJA and Turnkey Blood Conservation Program

8. Model for Process ControlBerte and Lupo Identify Procedures Draft SOPs Validate Process Finalize SOPs Train, Assess competence Monitor process

9. Model for Document Development“Model Quality System for Transfusion Medicine” Decide if SOP/document required Draft SOP/Training Guides Determine relationship to process overview (are other SOPs affected? New ones needed) User Input/Interview/Shadowing Identify practice changes: training

10. Model for Document Development Training Communication Plan Approval – formal signatures Distribution of new Archiving old Destruction of unnecessary copies

11. Introducing….. TOP 20 Questions

12. Question #1 What are Documents? SOP (e.g. Crossmatch) Method Policy (e.g. Indications Policy for Irradiated Products) Forms

13. Policies, Processes, Procedures

14. Question #2 What is a Quality Policy Statement? Forms the top of the document pyramid Forms the beginning of the documentation process Gives direction to the laboratory service quality operations Meaningful when reinforced and modeled to staff Best developed by a group involving all staff

15. Quality Policy Transfusion Medicine October 2000 Our purpose is to meet the needs and expectations of health care providers, patients and community in providing exemplary transfusion medicine service, education and research. Our commitment includes a quality management system using performance measures that are visible, challenging, and understandable and will provide for: A continuous improvement process Front line staff involvement Safe, effective transfusion products and service Collaboration, coordination and advocacy

16. Question #3Have you conducted a process analysis? “What is a process analysis?” A business oriented way to analyze operations and document the work activities Suited to identify SOP that are required Increases understanding of linkages with other departments Crosses traditional department and functional lines

17. Process Analysis Flowcharting Input – output Transfusion HRLMP example Incoming Blood Delivery (3 SOPs) Receiving of Inventory and Storage (6 SOPs) Manipulation of Components (>10 SOPs) Transport and Issuing (4 SOPs)

18. Question #4 Where do I start writing? Critical Control Points (CCPs) Process analysis will probably reveal lots of SOPs that need writing.. If not good! FDA – e.g. identifies Compatibility testing as a ‘system’ Sample collection is a CCP under that system Sample identification is a Key element .. Visual check is a control…

19. Question #5Any other issues to consider before writing SOP starts? Existing procedures in the lab or other departments that are impacted by this SOP? Standards relevant to an SOP? Best practices that need to be implemented? New information of any kind regarding a product? LIS changes that need to be made

20. Question #6How do I keep track of everything involved? Change control process Z902 4.4.2.5 “a system shall be established and maintained to identify, document, review and approve all process changes” Transitional planning – a form Title – Number – Source documents, including original SOP – LIS changes, communication Distribution locations – orientation locations

21. Question #7Help! Long list of SOPs…where do I start again? Prioritization model HRLMP Need for standardization of practice, meeting standards (Transport/packing of blood coolers) Risk to patient (NAIT platelet production – WB collection-Irradiation) Risk to staff (Emergency preparedness) New Methodology/instrumentation (Change in antibody detection method) Training

22. Question #8 How do I organize my table of contents? Keep track of old and new procedures? Table of contents – path of workflow – Patient, Specimen requirements Compatibility Testing SOPs and other Routine Methods Transfusion Reactions Quality Assurance

23. Question #8Table of Contents? Master Index? Keep track of old and new procedures? Master index/list– input all current titles using alphabetical listing (see example) Location (site specific or new), number important Key word locator or Software solution using Search type function Master file – contains copies of new approved version of SOP, previous versions of drafts, transitional planning form

24. Question 8 Numbering of procedures (training unit) Grading Reactions 08 -345-200 Preparing Red Cell Suspensions 08 345 201 ABO Cell Testing 08 345 202 ABO Plasma/Serum Testing 08 345 203 ABO Grouping using Patient’s plasma at 4C 08 345 204 ABO Discrepancy Workflow 08 345 205 Saline Replacement 08 345 206 ABO Discrepancies due to Acriflavin 08 345 207 Subgroup of A with Anti-A1 08 345 208

25. Question #9What Formats are acceptable? Okay, I know what I’m going to write about – what format should I use, what standards apply? Draft Z902 – 4.2.2.1 – Check HRLMP for: Name of facility Title and purpose of procedure Unique number identifying the document and revision Implementation date

26. Question #9What Formats are acceptable? Signature of authorizing person and date of authorization Page number/pagination (e.g. page 5 of 9) Clear outline of steps and instructions which shall match the details in records Do you need to change? ….Listen to users, staff Prepare templates to ease prep time Use of 2 templates – Technical, Operating

27. Question #10What are Standard Language Guidelines? Do rules exist for certain expressions? Are styles used consistent? Consistency = name of game Develop your guidelines, e.g., under “Purpose” – short clear statement “to describe steps required to wash RCC” Train anyone who writes SOPs with guidelines Standards may provide helpful definitions

28. Question #11Should SOP be long or short? Long or short SOPs – should we be making these lengthy and include all (less titles)? Short – many SOPs – highly specific titles – breakdown by ‘process’ steps Short = many titles to keep track of – many SOPs impacted by change Training Units/Related procedures LIS steps – in or out?

29. Question #12Is the SOP ready to go? Do you think everyone will like it? No, you’re not ready, and no, they will not like it User Input –suffices for individual SOP If you are implementing an entire new “Process” however, Validation is more complex Definition: Ensuring that a new method or instrument repeatedly does what you want it to under pre-defined conditions, using your process Validation – perform Prior to implementation

30. Question #12Is the SOP ready to go? Validation Validation Checklist -partial Purpose Description of System to be validated Responsibilities – Installation qualification, Maintenance and calibration, support services Requirements – SOPs, Personnel, equipment, other materials Test samples required, conditions, data, acceptance criteria Conclusions – Acceptability of results

31. Question #13What is Test Phase/User Input? No, really, how do you validate? Try to collect input from peers at draft stages Document the feedback “SOP Improvement Form” - suggestions on wording, related to specific steps Validation Documents – a Mirror Copy of SOP final version – signed off by individuals in the laboratory performing test runs

32. Question 13 - Validation Validation of Implementing New Technology -Checking equipment and testing it under all conditions -Parallel testing using multiple scenarios -Planned, systematic approach Validation of a single SOP Documentation of responsible staff members’ piloting through each step by signing and dating Suggestions, corrections can be documented as well and implemented in Implementation Version SOP

33. Question #14What are distribution locations? Do you place your SOPs in multiple locations? Distribution (controlled) locations must be identified in a quality environment Nursing stations – HIS – Laboratory reception – Research studies Electronic systems helpful --- Paper a reality Version control - implementation date “Uncontrolled copies” Post Locations

34. Question #14 Distribution Locations Example Number 7, 15, 23, 33, and 47 = designated numbers for 5 Transfusion locations Stem Cell lab Procedure “Operating the Control Rate Freezer #2 Supplied from Liquid Nitrogen Dewar” 08 348 516 – placed in Binder 47.5 (see Transitional Planning Form) Post Locations – numbered separately – need to display authorized copy of SOP in highly specific, designated locations

35. Question #15Are SOP ready to circulate? Approval Has your SOP been formally approved? Decide who needs to approve -early Medical Director – Transfusion Director Manager Other – Technical representative; Clinical representative Keep list to minimum

36. Question #16What do I do with old procedures? Once new SOP placed in lab – collect old ones Store in a designated location and system Paper or electronic Must be retrievable in reasonable time Memo used to communicate to Document control coordinator placing new documents and retrieving old ones for archiving

37. Question #17What happens if brand new SOP needs changes? Urgent or non urgent change Non urgent: Collection of feedback for next version Urgent: Immediate changes for critical omissions, errors, or change to product information Procedure Amendment form Produce a new version

38. Question #18What roles do we need? Quality Manager/Coordinator – puts Quality System plan in place Discipline Procedure Coordinator – keeps one department procedure development going Document Control Coordinator – places new documents in specified location, retrieves old Transfusion Technologist – does all this and crossmatches too

39. Question #19 What structures do we need? Transfusion Operations Committee –review Ops, practice issues requiring clinical input Transfusion Committee – subcommittee of MAC, clinical stakeholders Quality Council – Laboratory wide representation – advise on directions for “Quality Plan” TM Procedure team – staff, Tech Spec, Manager

40. Question #20What references are helpful? Draft Z902 CSA National Standards for Blood Safety Berte L., Lupo B. “Quality in Blood Banking” in Modern Blood Banking and Transfusion Practices, 4th Edition (Harmening D.) A Model Quality System for Transfusion Medicine - AABB & Ortho – 1997 AABB Standards 21st edition Nevalainen D., Berte L., Callery M. Quality Systems in the Blood Bank Environment, 2nd edition, 1998

41. Related Z902 Standards Development/Approval and Distribution 4.2.2 Change Control/Document Control process – 4.2.3 Distribution lists/locations 4.2.3.2 Archiving - 4.2.4.1 Process Validation - 4.4.2.3, 4.4.2.4 Critical control points, SOP (implied “Each activity that affects the quality and safety of a product) 4.2.1.1

42. Relevant OLA Requirements Change Control IIA.2 Document Control II.F, including Master Index II.F.4, Archiving II.F.6 Process Validation II.A.2 Process Analysis II.A.2 Quality Policy Statement II.B.1 tp .5

43. Questions we can’t answer Should a whole region have the same system? How many dollars are available to implement a sustainable system? A system that meets standards? What roles will work in all laboratory services? Should typing be done by typists or technologists? What is the best software system to support all of this?

44. Lessons Learned Titles are very important Master file – tracking of where things are – vital! Master Index – staff must have this to deal with locating SOPs in a purely paper system Release ‘training units’ of SOPs not one here, one there Constant change a challenge Communicate with staff, clinical contacts constantly

45. Summary Document Development -Critical Control points -Process Analysis -Training concerns -User input -Validation -Approval Document Control -Numbering/identification -Version identification -Change Control -Master File -Master Index -Distribution system -Archiving

46. Acknowledgements Diana Boye and Silvia Sunesen – Quality Associates, QUEST - Hamilton Cathie McCallum, Quality Manager, HRLMP Beth Harriman (HRLMP) and Angela Fiorillo (QUEST) Administrative Coordinators Rosanne Frassetto and Sharon McMillan, Quality Associates, QUEST – Niagara Pam O’Hoski, Connie Lester, Julie DiTomasso and Denise Evanovitch – fellow Tech Specialists Nancy Heddle, Project Advisor, QUEST and Duane Boychuk, Manager, Transfusion Medicine HRLMP

47. “Total Quality System”