t ransfusion medicine – laboratory management joan macleod, mlt, dba district technical manager...
TRANSCRIPT
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TRANSFUSION MEDICINE –
LABORATORY MANAGEMENT
Joan MacLeod, MLT, DBA
District Technical Manager
Blood Transfusion Service
Capital Health
Halifax, Nova Scotia
March 27, 2012
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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
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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
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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 ClericalIncludes “on call weekend coverage” for Provincial
service
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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
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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
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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
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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
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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
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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
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BLOOD TRANSFUSION SERVICE
Accreditation Canada - November 2010 - Every 3 years
Standards:1) AABB: Standards for Blood Banks and
Transfusion Services. 27th Edition 2) CAN/CSA: Z902-10: Blood and Blood
Components 3) CSTM: Standards for Hospital Transfusion
Services. Version Sept 2007 “Go to highest standard”
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DOCUMENTATION
Say what you do!
Do what you say!
Document! Document! Document!
“If not, you have not done it”
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“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
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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
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ORGANIZATION Outline Organizational Structure - Overall Health Structure - Pathology & Laboratory Medicine - Blood Transfusion Service
Reporting & Accountability - Administrative & Technical
Responsibilities of Individuals
Facility Description - Service Provision
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HUMAN RESOURCES
Job Descriptions - Scope of Practice
Employee Qualifications - License to Practice
Orientation - Organization/Laboratory/Blood Transfusion
Training - Training Document
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HUMAN RESOURCES
Assessment of Competency - Training/Yearly Schedule
Continuing Education - Ongoing knowledge
Trainer Qualification - Criteria needs to be established
Professional Development - Shared Accountability
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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
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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
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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
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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
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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
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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
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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
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PROCESS CONTROL
Quality Control - Meets requirements - Review process - Corrective Actions
Process & Product Specifications - Meets standards
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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
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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
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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
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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)
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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
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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
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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
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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
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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
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FACILITIES & SAFETY
Safety Training for Staff - Yearly review/competence in fire drills,
WHIMS, MSDS, Safety policies
Biological Hazards - Identifcation - Disposal of hazard waste - Spills
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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
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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
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BLOOD TRANSFUSION SERVICE
Lean Management Initiatives Ortho P3 - Moved 3 ProVues to Front-end - 20 minute load - Standard Practice
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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
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2010-2011 O Pos A Pos B Pos AB Pos O Neg A Neg B Neg ABNeg Total Red Cells
Rec'd
RBC Outdate
Rate O & A
Outdates B & AB
Outdates
April 3 19 1 1 7 0 0 11 42 1240 3.4% 29 13
May 2 4 4 8 7 0 0 5 30 1336 2.2% 13 17
June 0 1 1 6 18 0 0 7 33 1417 2.3% 19 14
July 2 2 0 1 23 0 3 9 40 1345 3.0% 27 13
August 0 0 0 4 1 2 1 4 12 1229 1.0% 3 9
September 2 1 0 3 7 3 2 9 27 1442 1.9% 13 14
October 0 0 2 1 12 2 2 4 23 1442 1.6% 14 9
November 0 1 0 2 6 0 7 5 21 1256 1.7% 7 14
December 0 0 0 5 15 0 2 6 28 1354 2.1% 15 13
January 0 0 3 5 19 3 3 8 41 1288 3.2% 22 19
February 0 2 0 3 9 3 5 4 26 1218 2.1% 14 12
March 0 3 0 5 0 4 0 10 22 1395 1.6% 7 15
Total 9 33 11 44 124 17 25 82 345 15962 2.2% 183 162
2011-2012 O Pos A Pos B Pos AB Pos O Neg A Neg B Neg ABNeg Total Red Cells
Rec'dRBC Outdate
Rate O & A
Outdates B & AB
Outdates
April 0 3 3 5 0 4 1 10 26 1252 2.1% 7 19
May 1 0 2 0 17 2 4 4 30 1347 2.2% 20 10
June 1 0 2 0 1 4 6 7 21 1398 1.5% 6 15
July 0 0 0 0 0 3 6 9 18 1229 1.5% 3 15
August 0 0 1 2 0 0 0 7 10 1298 0.8% 0 10
September 2 0 0 2 0 1 1 0 6 1447 0.4% 3 3
October 0 0 0 2 2 4 2 5 15 1378 1.1% 6 9
November 0 0 0 4 0 0 1 6 11 1305 0.8% 0 11
December 0 0 0 8 0 0 4 5 17 1391 1.2% 0 17
January 1 0 7 7 1 2 11 3 32 1550 2.1% 4 28
February 0 0 3 0 0 13 4 0 20 1180 1.7% 13 7
March
Total 5 3 18 30 21 33 40 56 206 14775 1.4% 62 144
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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%
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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
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QUESTIONS