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Transfusion medicine – laboratory management

Transfusion medicine – laboratory management. Joan MacLeod, MLT, DBA District Technical Manager Blood Transfusion Service Capital Health Halifax, Nova Scotia March 27, 2012. Learning objectives. Discuss the requirements of a Quality Management System in a Blood Transfusion Service

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Transfusion medicine – laboratory management

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  1. Transfusion medicine – laboratory management Joan MacLeod, MLT, DBA District Technical Manager Blood Transfusion Service Capital Health Halifax, Nova Scotia March 27, 2012

  2. Learning 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. Blood Transfusion 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. Blood Transfusion 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. Blood Transfusion 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. Blood Transfusion 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. Blood Transfusion 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. Blood Transfusion service • Haematopathologists - Include Director: 6 • Transfusion Medicine Followship Program • Haematopathology Training Program • Pathology Training Program • Anaesthesia Resident Training • Medical Laboratory Technologist Students – Clinical

  9. Blood Transfusion 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. Blood Transfusion service Accreditation • American Association of Blood Banks - 1st BTS in Canada - As of 1994 – Victoria General site - Now District Blood Transfusion Service - Bi-annual accreditation Latest assessment: December 2011

  11. Blood Transfusion service • Accreditation Canada - November 2010 - Every 3 years Standards: • AABB: Standards for Blood Banks and Transfusion Services. 27th Edition • CAN/CSA: Z902-10: Blood and Blood Components • CSTM: Standards for Hospital Transfusion Services. Version Sept 2007 “Go to highest standard”

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

  13. “Vein 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. Blood Transfusion service Quality 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. Organization • Outline Organizational Structure - Overall Health Structure - Pathology & Laboratory Medicine - Blood Transfusion Service • Reporting & Accountability - Administrative & Technical • Responsibilities of Individuals • Facility Description - Service Provision

  16. Human Resources • Job Descriptions - Scope of Practice • Employee Qualifications - License to Practice • Orientation - Organization/Laboratory/Blood Transfusion • Training - Training Document

  17. Human Resources • Assessment of Competency - Training/Yearly Schedule • Continuing Education - Ongoing knowledge • Trainer Qualification - Criteria needs to be established • Professional Development - Shared Accountability

  18. Equipment • 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. Equipment • 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. Equipment • 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. Supplier & 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. Supplier & 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. Process 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. Process 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. Process control • Quality Control - Meets requirements - Review process - Corrective Actions • Process & Product Specifications - Meets standards

  26. Process 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. Document 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. Deviations, 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. Deviations, 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. Deviations, 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. Assessments: Internal & External • 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. Process Improvement through Corrective & Preventive Action • 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. Process Improvement through Corrective & Preventive Action • 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. Facilities & 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. Facilities & safety • Safety Training for Staff - Yearly review/competence in fire drills, WHIMS, MSDS, Safety policies • Biological Hazards - Identifcation - Disposal of hazard waste - Spills

  36. Quality 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. Quality 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

  38. Blood Transfusion service • Lean Management Initiatives • Ortho P3 - Moved 3 ProVues to Front-end - 20 minute load - Standard Practice

  39. Blood Transfusion 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

  40. Blood Transfusion 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%

  41. Blood Transfusion 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

  42. QUESTIONS

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