transfusion medicine – laboratory management
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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
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
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
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
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
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
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
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
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
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
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”
DOCUMENTATION
Say what you do!
Do what you say!
Document! Document! Document!
“If not, you have not done it”
“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
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
ORGANIZATION Outline Organizational Structure - Overall Health Structure - Pathology & Laboratory Medicine - Blood Transfusion Service
Reporting & Accountability - Administrative & Technical
Responsibilities of Individuals
Facility Description - Service Provision
HUMAN RESOURCES
Job Descriptions - Scope of Practice
Employee Qualifications - License to Practice
Orientation - Organization/Laboratory/Blood Transfusion
Training - Training Document
HUMAN RESOURCES
Assessment of Competency - Training/Yearly Schedule
Continuing Education - Ongoing knowledge
Trainer Qualification - Criteria needs to be established
Professional Development - Shared Accountability
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
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
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
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
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
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
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
PROCESS CONTROL
Quality Control - Meets requirements - Review process - Corrective Actions
Process & Product Specifications - Meets standards
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
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
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
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)
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
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
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
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
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
FACILITIES & SAFETY
Safety Training for Staff - Yearly review/competence in fire drills,
WHIMS, MSDS, Safety policies
Biological Hazards - Identifcation - Disposal of hazard waste - Spills
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
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
BLOOD TRANSFUSION SERVICE
Lean Management Initiatives Ortho P3 - Moved 3 ProVues to Front-end - 20 minute load - Standard Practice
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
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
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%
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