1. T RANSFUSION MEDICINE – LABORATORY MANAGEMENT Joan MacLeod, MLT, DBA District Technical Manager Blood Transfusion Service Capital Health Halifax, Nova Scotia March 27, 2012

2. L EARNING OBJECTIVES Discuss the requirements of a Quality Management System in a Blood Transfusion Service Provision of Quality Indicators to improve Transfusion Service LEAN management initiatives for improved Turn Around Times Blood utilization initiatives to reduce wastage and manage inventory

3. B LOOD T RANSFUSION SERVICE District Service  4 Blood Transfusion Testing sites  8 Transfusion sites  Management structure: - District Medical Director – Dr Irene Sadek - District Technical Manager – Joan MacLeod - QEII HSC Supervisor - Manager Community Based Labs - Dartmouth General Supervisor - Hants Community Supervisor

4. B LOOD T RANSFUSION SERVICE Provincial Antibody Identification Referral Service  Capital Health sites - 2500 case/year - 65% Routine & 35% Complex  30 Provincial Hospitals (9 DHAs) - 400 cases/year Staffing (FTES): 1 MLT A 1 MLTC 0.5 MLA 0.5 Clerical Includes “on call weekend coverage” for Provincial service

5. B LOOD T RANSFUSION SERVICE QEII Health Sciences Centre: Halifax Infirmary & Victoria General Sites - Dedicated Blood Transfusion staff - Main site - Automation (3 ProVues) - Antibody Identification Staffing (FTE): 21.6 MLT A 5 MLT C (Technical Specialists) Transfusion Practice Nurse 1.5 MLA 1.0 Clerical

6. B LOOD T RANSFUSION SERVICE Dartmouth General Hospital: Core lab staff Staffing: 17 Medical Lab Technologists (3 of 17 are BTS Key Operators) “District BTS Management” Hants Community Hospital: Core lab staff Staffing: 5 Medical Lab Technologists “District BTS Management” Pathology Informatics Analyst - Close working relationship

7. B LOOD T RANSFUSION SERVICE Size: Average 1000 bed Crossmatchs: 26,042 (80% electronic) Transfusion Data (2010-2011) Red Cells: 14,877 Apheresis Platelets: 847 Buffy Coat Platelet Pools: 1,549 Apheresis Plasma: 2,352 Frozen Plasma: 345 Cryoprecipitate: 3,303 Derivatives: 25,000

8. B LOOD T RANSFUSION SERVICE Haematopathologists - Include Director: 6 Transfusion Medicine Followship Program Haematopathology Training Program Pathology Training Program Anaesthesia Resident Training Medical Laboratory Technologist Students – Clinical

9. B LOOD T RANSFUSION SERVICE Workload Measurement - Unit Producing Activity - Non-Service Activity  CIHI: New System in 2009  Used to determine staffing/productivity/cost per test  Challenge: Inventory Management is considered Non- Service Activity  Standardized but not implemented across Canada  No Benchmarks to date

10. B LOOD T RANSFUSION SERVICE Accreditation American Association of Blood Banks - 1 st BTS in Canada - As of 1994 – Victoria General site - Now District Blood Transfusion Service - Bi-annual accreditation Latest assessment: December 2011

11. B LOOD T RANSFUSION SERVICE Accreditation Canada - November 2010 - Every 3 years Standards: 1) AABB: Standards for Blood Banks and Transfusion Services. 27 th Edition 2) CAN/CSA: Z902-10: Blood and Blood Components 3) CSTM: Standards for Hospital Transfusion Services. Version Sept 2007 “Go to highest standard”

12. D OCUMENTATION Say what you do! Do what you say! Document! Document! Document! “If not, you have not done it”

13. “V EIN TO VEIN ” RESPONSIBILITIES Quality of Blood, Blood Components & Derivatives on Receipt Storage, Packing & Transport Testing: Routine & Complex Request & Dispense “ Dispense of right product to the right patient at the right time” Transfusion nursing practice Ensure nursing transfusion competency Transfusion Documentation – Traceability Adverse Event Reporting

14. B LOOD T RANSFUSION SERVICE Q UALITY MANAGEMENT SYSTEM Quality System Essentials  Organization  Human Resources  Equipment  Suppliers & Customer Issues  Process Control  Documents & Records Management  Deviations, Non-Conformances & Adverse Events  Assessments: Internal & External  Process Improvement through Corrective & Preventive Action  Facilities & Safety

15. O RGANIZATION Outline Organizational Structure - Overall Health Structure - Pathology & Laboratory Medicine - Blood Transfusion Service  Reporting & Accountability - Administrative & Technical Responsibilities of Individuals Facility Description - Service Provision

16. H UMAN R ESOURCES Job Descriptions - Scope of Practice Employee Qualifications - License to Practice Orientation - Organization/Laboratory/Blood Transfusion Training - Training Document

17. H UMAN R ESOURCES Assessment of Competency - Training/Yearly Schedule Continuing Education - Ongoing knowledge Trainer Qualification - Criteria needs to be established Professional Development - Shared Accountability

18. E QUIPMENT Determine requirements for purchase - Work with Purchasing Dept &/or Vendor - RFP or RFI/ Sole Source - Budget/Capital Equipment/Emergency Replacement Selection - Standards to met, i.e. Refrigeration equipment Installation - Vendor/Refrigeration/BioMedical/Manual Calibration - As per manual/standards

19. E QUIPMENT Validation - Validation plan Preventive Maintenance & Repairs - Schedule: Manual and/or standards Critical list of Equipment - Establish list: Name, Model, Serial #, ID#, Supplier, Location, Expiry Calibration/PM Defective Equipment - Document & archive/discard

20. E QUIPMENT Storage devices for Blood, Blood Components, Derivatives and Reagents Alarm Systems - Local or centralized Warming Devices for Blood & Blood Components - BioMedical Department : Documentation - Location of devices Computer Systems - Validated computer system

21. S UPPLIER & CUSTOMER ISSUES Qualified Suppliers - Deliver Quality Product & Service Purchase contracts - Standing orders & on demand for reagents Service Agreements - Purchase for scheduled maintenance & repairs - Automation (ProVues), Refrigerators, Microscopes

22. S UPPLIER & CUSTOMER ISSUES Receipt, Inspection & Testing of Incoming Supplies - Reagent orders, inspection for shipping & quality of the products received and testing to meet established criteria Contacts with Referral Laboratories for Services - Referred testing to outside laboratories

23. P ROCESS CONTROL Development of Standard Operating Policies, Processes and Procedures (SOPs) - Meets standards, standardized SOPs & management approval Change Control - Changes are documented and approved - Needs a SOP describing change control process Information Systems - Hardware & Software validated prior to use - Upgrades

24. P ROCESS CONTROL Process Validation for New or Changes in Processes or Procedures - Validate & document validation & person who validated Labeling Process - Document process to ensure tracking of labelling: i.e. Thawing plasma Proficiency Testing - Ensure outcome is as expected for test procedures - CAP Surveys, TekCheks - Determine frequency of staff compliance

25. P ROCESS CONTROL Quality Control - Meets requirements - Review process - Corrective Actions Process & Product Specifications - Meets standards

26. P ROCESS CONTROL Non-Conforming Blood, Blood Components and Derivatives - Process for staff to follow - Consult with Medical Director - Canadian Blood Service or vendor Final Inspection & Testing - Criteria prior to release to patient Handing, Storage, Distribution and Transport - Storage requirements determined & maintained - Packing for distribution & Transport

27. D OCUMENT AND RECORD MANAGEMENT Document Control process - Paper system - Electronic System (Paradigm 3) Generate, Review, Retain & Retrieve Documents - Standardized format - Linkage of documents: SOPs, forms, Job Aides - Review and control process - Record retention schedule – standards/provincial laws Obsolete documents - Archive process/schedule: paper/electronic

28. D EVIATIONS, NON - CONFORMANCES & ADVERSE EVENTS Deviations to SOPs - Document deviation, reasons for deviations, corrective action - Requires management and medical director follow-up and/or approval - Planned or unplanned - Example: Disruption in reagent supply

29. D EVIATIONS, NON - CONFORMANCES & ADVERSE EVENTS Non-Conformances - Tracking, trending and analysis - Blood products, reagents, equipment, procedures - Corrective action  Systems used: - Patient Safety Reporting: Disclosure may be required - Laboratory Non-Conformances - Transfusion Error Surveillance System (TESS)

30. D EVIATIONS, NON - CONFORMANCES & ADVERSE EVENTS Adverse Events - Related to donation (CBS) - Related to Transfusion Recipient - Serious vs Non-Service reporting structure - Tracking, Trending and Reporting - Transfusion Transmitted Injury Surveillance System (TTISS) - Lookback/Traceback Processes

31. A SSESSMENTS : I NTERNAL & E XTERNAL Internal Assessments - Yearly schedule - Routine audits - Audits identified due to issues - Record review and/or observational audits - Review by QA Committee External Assessments - AABB - Accreditation Canada - Peer review

32. P ROCESS I MPROVEMENT THROUGH C ORRECTIVE & P REVENTIVE A CTION Corrective Action - Identify deviation, non-conformance or complaint - Review and develop action plan - Determine if effective Preventive Action - Identify potential problem or non-conformance - Review and develop action plan - Determine if effective

33. P ROCESS I MPROVEMENT THROUGH C ORRECTIVE & P REVENTIVE A CTION Identification and Action  Blood Transfusion Committee  Staff Meetings  QA Committee  Management Team  Laboratory Quality Council  Laboratory Safety Committee  Canadian Blood Services/Hospital Management Committee

34. F ACILITIES & SAFETY Safety Program - Health Centre/Pathology & Lab Medicine and Blood Transfusion Hazards Assessment - Identify hazards and risk reduction actions Reporting of Incidents, Accidents & Hazards - Safety Committee, Occupational Health and Safety Teams and Staff

35. F ACILITIES & SAFETY Safety Training for Staff - Yearly review/competence in fire drills, WHIMS, MSDS, Safety policies Biological Hazards - Identifcation - Disposal of hazard waste - Spills

36. Q UALITY INDICATORS C:T ratio - Less 2:1 - Review Maximum Surgical Blood Order (MSBO) - Specific to hospitals Red Cell Outdates - Less than 2% - Redistribution Turn Around Times - STATs: 1 Hour - Urgent: 3 Hours - Routine: 8 Hours

37. Q UALITY INDICATORS Platelet Outdates - Provide ABO Specific and/or BMT requirement - Challenge: Supply & 5 day shelf life Specimen rejection rates - Less than 2% - Determine collector: MLAs vs Nurses Blood product wastage - Natural expiry - Indate wastage

39. B LOOD T RANSFUSION SERVICE Lean Management Initiatives  Ortho P3 - Moved 3 ProVues to Front-end - 20 minute load - Standard Practice

43. B LOOD T RANSFUSION SERVICE  Dashboards – Red Cells - Reduced Red Cells outdates from 2.4% in 2009/10 to 1.2% in 2010/11 - Redistribution within district @ 14 days to outdate - Provincial initiative underway

44. 2010-2011O PosA PosB PosAB PosO NegA NegB NegABNegTotal Red Cells Rec'd RBC Outdate Rate O & A Outdates B & AB Outdates April31911700114212403.4%2913 May244870053013362.2%1317 June0116180073314172.3%1914 July2201230394013453.0%2713 August000412141212291.0%39 September210373292714421.9%1314 October0021122242314421.6%149 November010260752112561.7%714 December0005150262813542.1%1513 January0035193384112883.2%2219 February020393542612182.1%1412 March0305040102213951.6%715 Total9331144124172582345159622.2%183162 2011-2012O PosA PosB PosAB PosO NegA NegB NegABNegTotal Red Cells Rec'd RBC Outdate Rate O & A Outdates B & AB Outdates April0335041102612522.1%719 May1020172443013472.2%2010 June102014672113981.5%615 July000003691812291.5%315 August001200071012980.8%010 September20020110614470.4%33 October000224251513781.1%69 November000400161113050.8%011 December000800451713911.2%017 January1077121133215502.1%428 February0030013402011801.7%137 March Total53183021334056206147751.4%62144

45. B LOOD T RANSFUSION SERVICE Lean Management Initiatives  Dashboard: Platelets - Thrombocytopenic patients (48 hrs) - District platelet supply - Platelet ordering tool Platelet outdates Dec 2010-March 2011: 27% Platelet outdates in Sept – Oct 2011: 13.6- 15%

46. B LOOD T RANSFUSION SERVICE Blood Track HemoSafe Refrigerators - One for Halifax Infirmary – Operating Room - One for Victoria General – outside BTS Goals:  Reduce Operating Room wastage  Reduce Operating Room returns: average 40- 60%  Close Victoria General BTS during Evening shift  Reduce Cooler use in Operating Room  Reduction in one FTE MLTA

48. QUESTIONS