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

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


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


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


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


Haematopathologists - Include Director: 6

Transfusion Medicine Followship Program

Haematopathology Training Program

Pathology Training Program

Anaesthesia Resident Training

Medical Laboratory Technologist Students – Clinical


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


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


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


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)


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


Lean Management Initiatives Ortho P3 - Moved 3 ProVues to Front-end - 20 minute load - Standard Practice


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


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 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

QUESTIONS

Transfusion medicine – laboratory management

Documents

hospital transfusion

electronic transfusion

blood components cstm

inventory management

quality management system

core lab staff staffing

provincial hospitals

casesyear staffing ftes