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 Clerical
Includes “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 NonService 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
Do
what you 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
Capial Health - Blood Transfusion Services
Crossmathed:Transfused (C:T) Ratio
2006 - 2012
2.5
2
C: T Ratio
1.5
1
0.5
0
2006-2007
2007-2008
2008-2009
2009-2010
2010-2011
2011-2012
April
2.24
1.78
1.79
1.72
1.76
1.73
May
2.30
1.64
1.52
1.69
1.70
1.77
June
2.05
1.58
1.65
1.64
1.73
1.73
July
2.15
1.78
1.52
1.70
1.66
1.72
August
2.05
1.56
1.61
1.71
1.79
1.57
Sept
2.23
1.71
1.66
1.73
1.66
1.63
Oct
2.31
1.71
1.57
1.74
1.76
1.72
Months of Year
Nov
1.81
1.71
1.57
1.75
1.83
1.67
Dec
1.57
1.64
1.63
1.71
1.66
1.64
Jan
1.76
1.67
1.63
1.74
1.78
1.65
Feb
1.72
1.64
1.59
1.73
1.77
1.67
Mar
1.72
1.72
1.65
1.67
1.95
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
Red Cells
Rec'd
RBC
Outdate
Rate
O&A
Outdates
B & AB
Outdates
1240
1336
1417
1345
1229
1442
1442
1256
1354
1288
1218
1395
15962
3.4%
2.2%
2.3%
3.0%
1.0%
1.9%
1.6%
1.7%
2.1%
3.2%
2.1%
1.6%
2.2%
29
13
19
27
3
13
14
7
15
22
14
7
183
13
17
14
13
9
14
9
14
13
19
12
15
162
2010-2011
April
May
June
July
August
September
October
November
December
January
February
March
Total
O Pos
3
2
0
2
0
2
0
0
0
0
0
0
9
A Pos
19
4
1
2
0
1
0
1
0
0
2
3
33
B Pos
1
4
1
0
0
0
2
0
0
3
0
0
11
AB Pos
1
8
6
1
4
3
1
2
5
5
3
5
44
O Neg
7
7
18
23
1
7
12
6
15
19
9
0
124
A Neg
0
0
0
0
2
3
2
0
0
3
3
4
17
B Neg
0
0
0
3
1
2
2
7
2
3
5
0
25
ABNeg
11
5
7
9
4
9
4
5
6
8
4
10
82
Total
42
30
33
40
12
27
23
21
28
41
26
22
345
2011-2012
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
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
5
3
18
30
21
33
40
56
206
14775
1.4%
62
144
March
Total
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 4060%
 Close Victoria General BTS during Evening shift
 Reduce Cooler use in Operating Room
 Reduction in one FTE MLTA
QUESTIONS