TOTAL LABORATORY

QUALITY MANAGEMENT

SEMILOKA MUTU XIV

DATE: 9 APRIL 2016
SEAN PETERS
[Link]@[Link]

PRIMARY HEALTH CARE LIMITED

Delivering nationwide coverage

As at 30 June 2015
2

PATHOLOGY / CLINICAL LABORATORIES

DIVISION
PRIMARY HEALTH CARE LTD IS ONE OF WORLDS LEADING DIAGNOSTIC PROVIDERS

Public Company
Top 100 ASX listed
US$ 1.4bn Market cap
Established >30 years
Founded by Dr Edmund Bateman
Blue Chip Institutional Shareholders
Australian based

Medical Centre
Division
~
~

~
~

US$ 218m revenues

7.5 m GP patient
consultations p.a.
1000 medical
practitioners
1670 employees

100%

Pathology / Clinical
Laboratories Division
~
~
~
~

US$ 690m revenues

15m patients p.a.
200 pathologists
8000 employees

Diagnostic Imaging
Division
~
~

~
~
~

US$250m revenues
2.5m examinations
p.a.
150 Imaging Centres
200 specialist
radiologists
150 CTs, 25 MRI
licenses, 200
Ultrasounds
1700 technical and
administrative
employees

Medical Information
Technology
~
~
~
~
~

US$28m revenues
16,000 doctor users
60m patient
consultations
4,400 customer sites
150 employees

PATHOLOGY / CLINICAL LABORATORIES

DIVISION BUSINESS UNITS
LEADING PATHOLOGY PROVIDER ON A WORLD SCALE
Specialist Diagnostic Services Pty Ltd, SDS, our Pathology/Clinical Laboratories Division
Operates 5 practices, with ~ 8000 dedicated scientists, phlebotomists & support staff, > 100 laboratories
Servicing over 15 million patients p.a.
Hundreds of millions individual tests p.a.
All in vitro diagnostic disciplines including:
Biochemistry, Toxicology,
Microbiology, Virology,
Serology, Immunology,
Haematology, Cytology,
Histopathology
Molecular Biology, and Genetics.
.
All laboratories accredited
US$690m revenue
to ISO 15189 (2012)

100%

Each Pathology Business Unit is separately branded and managed - to retain local focus and goodwill
Network-wide decisions are made on infrastructure, testing, group purchasing, subspecialisation, quality policies etc.

PRESENTATION OVERVIEW
Total Laboratory Quality Management A Definition

Quality Management System and Quality System Essentials

(QSEs)
Sequence and Interrelation of Quality Management System
Processes (QMSP)

QMSPs and Sub-related Processes

Monitoring of Key Performance Indicators
Continuous Improvement

Laboratory Model for Operational Excellence (7 Element

(OEMS)
PDCA Cycle

Summary
2

TOTAL LABORATORY QUALITY MANAGEMENT

(TLQM) A DEFINITION
TLQM Defined
Total quality control, total quality
leadership, continuous quality
improvement, quality
management science/
industrial quality
management.
Management philosophy for
organisational development,
a management process for
improvement of laboratory
operation and quality of the
request-test-report cycle.
*WHO Laboratory Quality Management System Handbook, Version 1.1, 2011
2

CLSI QUALITY STAGES MODEL

Systematic approach to build quality into the laboratorys processes,
assess the laboratorys performance, and implement quality
improvements
STAGE
Total Quality Management
Quality Cost Management
Quality Management System
Quality Assurance
Quality Control

ACTIVITIES PERFORMED
Management approach centred on sustained high quality, by
focusing on long-term success through customer satisfaction
Includes the stages below and also the economic aspects of the
Cost of Quality
Systematic process-oriented approach to quality objectives
Planned and systematic activities to provide confidence that an
organisation fulfils requirements for quality
Operational process control techniques to fulfil requirements
for quality and regulatory/governmental compliance

SENSITISATION/REALISATION

All SDS Laboratories have

implemented a TQM Model
2

* CLSI QMS01-A4

QUALITY MANAGEMENT SYSTEM (QMS) AND QUALITY

SYSTEM ESSENTIALS (QSES)

QMS Definition Coordinated activities to

direct and control an
organisation with regard to
quality (ISO,CLSI).
QSE CLSI QMS model
arranges all laboratory
activities into 12 QSEs.
All 12 must be addressed to
ensure achieve overall
laboratory quality
improvement.
Good management of
QSEs assures accuracy
and reliability throughout
the path of workflow.

10

11

12

*WHO Laboratory Quality Management System Handbook, Version 1.1, 2011

2

QUALITY MANAGEMENT SYSTEM (QMS) AND QUALITY

SYSTEM ESSENTIALS (QSES) (CONT.)

*CLSI QMS01-A4, Quality Management System: A Model for Laboratory Services; Approved Guideline Fourth Edition
2

SPECIALIST DIAGNOSTIC SERVICES MODEL

TLQM achieved by defining Quality Management System Processes
(QSEs)
Organisation & Management - Commitment, Policies (including the Quality,
Privacy and WHS Policies), Authorities and Responsibilities, Planning and Risk
Assessment, Clinical Governance, Ethics i.e. Organisation (1)
Client/Customer - Requirements and Contracts, Customer Focus (11)
Resource Management Personnel (2), Documentation (7), Facilities Design
and Development/Accommodation and Environment (12), Equipment (3),
Information Technology (6)
Product Realisation - Approving Suppliers, Purchasing and Receiving of
Materials (4)
Production and Service Provision, Process Control - Laboratory Process (5)
(pre-examination, laboratory analysis or examinations, assuring quality, post
examination and reporting)
Process Measurement and Improvement - Analysis, Review, Improvement
(10) and Measurement Uncertainty
Client Related Processes - Advisory Services, Resolution of Complaints,
Customer/Client Feedback (11), and
Management Review and Continual improvement Incidents (8), Audits (9),
Key Performance Indicators.
10

SPECIALIST DIAGNOSTIC SERVICES MODEL (CONT.)

SDS TLQM design:

Strongly aligned to the organisations business
objectives
Aligned to business environment (including client
requirements)
Aligned to strategic plan
Considers regulatory and legislative changes
affecting the business environment
Considers any associated risks

11

SDS QUALITY MANAGEMENT SYSTEM PROCESSES (QSES)

Effective on a National Level Across All Laboratories

12

SDS PTY LTD QUALITY MANAGEMENT SYSTEM

SUB-PROCESSES PATH OF WORKFLOW

Request
Review
Patient
Identification
& Consent
Phlebotomy/
Self
Collection

Specimen
Collection

13

Specimen
Transport
Timeframes
Specimen
Integrity,
Temperature
Maintenance
Safety

Identity
Verification/Traceability
Evaluation,
Acceptance/Rejection
Criteria; Recollections
LIS Registration,
including Date and Time
Urgent Processing
Needs

Specimen
Receipt and
Conditioning

Specimen
Testing
Specimen
Preparation
Methods
validation
and
verification
Repeat
Testing

Results
Verification
Abnormal
results
IQC Data
Transcription
Error Checks

Report
Provision
to Client
Telephoned
results
Report
Content
Report
Validation
Amended
Reports
Invoicing

SDS QUALITY MANAGEMENT SYSTEM PROCESSES

AND SUB-PROCESSES (CONT.)
All QMS processes and sub-processes clearly documented in controlled policies,
procedures, methods and work instructions. There are defined systems for record
keeping information is the major product of the laboratory, and needs to be
managed carefully.

Activities are carried out or conducted by qualified, trained and competent

personnel, who possess integrity, recognize the importance of their work and
participate in continuous improvement.
*WHO Laboratory Quality Management System Handbook, Version 1.1, 2011
14

KEY PERFORMANCE INDICATORS (KPIS)

(INCLUDING ECONOMIC ASPECTS)

OPERATIONAL INDICATORS
Patient Statistics

Doctor Statistics

Collection Centre
Statistics and Collector
Workload

Occurrences (including
complaints)

Data Entry Operator

Workload/Statistics

PRE-ANALYTICAL INDICATORS
Request Form Errors

Sample Labelling Errors

Incorrect Collection

Recollection Rates

Data Entry Error Rates

Transport Temperature
Failures

15

KEY PERFORMANCE INDICATORS (KPIS) (CONT.)

ANALYTICAL INDICATORS
Turn-Around-Time (TAT) data relevant for the patient demographic, clinical parameters
or laboratory location, determined in consultation with requesters and/or to meet
contractual arrangements
Amended Reports

Internal QC Reviews

PT/EQAP Performance
and Participation

Continuing Education &

Competency
Assessments

Supervisory Activity (where relevant)

POST-ANALYTICAL INDICATORS
Report Delivery Errors (via client feedback)

16

KPIS - PROCESS CONTROL SAMPLE MANAGEMENT

The quality of the work a laboratory produces is only as good as the
quality of the samples it uses for testing.
Appropriate sample management

critical to the accuracy and reliability of testing

provides confidence in laboratory diagnosis.
Inaccuracies in testing

impact length of hospital stays

affects laboratory efficiency, leading to repeat testing with
resultant waste of personnel time, supplies and reagents.
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KPIS - PROCESS CONTROL SAMPLE MANAGEMENT

Sample Management Components

Information needed on requisitions or forms;
Handling urgent requests;
Collection, labelling, preservation and transport;
Safety practices (leaking or broken containers,
contaminated forms, other biohazards);
Evaluating, processing and tracking samples;
Storage, retention and disposal.

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KPIS - PROCESS CONTROL SAMPLE MANAGEMENT

RECOLLECTS

Reasons

ACC

Dr

Comb

136

113

27%

Insufficient

51

67

13%

Latelist

112

66

19%

Lost Specimen

16

2%

No Specimen Collected

Clotted Specimen

55

6%

Repeat Suggested

23

10

4%

Wrong Tube Type

17

35

6%

Unlabelled Specimen

14

14

3%

No Collector's Declaration

1%

Haemolysed Specimen

37

5%

Test uncoded on Ultra

15

2%

Unsigned Specimen

1%

Other

64

37

11%

Total:

461

454

100%

Recollection Site:

Total

Main Heidelberg Lab:

684

Metro Peripheral Labs:

138

Country Peripheral Labs:

149

Top 5 Panel Types:

18%

7%

FBE

5%

4%

EUC

ESR

COA

10%

8%

Citrate
tube

Urine
(MSU)

Top 5 Specimen Types:

Cause breakdown:
Laboratory / Data Entry Origin:

220

24%

Dorevitch Collections:

226

25%

Hospital Collections:

58

6%

External Origin:

275

30%

30%

EDTA
tube

19

URC

6%

19%

SST tube

4%
Faeces

KPIS - PROCESS CONTROL SAMPLE MANAGEMENT

DATA ENTRY
0
-200
-400

-600

6:00

7:00

8:00

9:00

10:00

11:00

12:00

13:00

14:00

15:00

16:00

17:00

18:00

19:00

20:00

21:00

22:00

23:00

6:00

7:00

8:00

9:00

10:00

11:00

12:00

13:00

14:00

15:00

16:00

17:00

18:00

19:00

20:00

21:00

22:00

23:00

-800
-1000
-1200
-1400

3000
2500
2000
1500
1000
500
0

Total

20

KPIS - PROCESS CONTROL SAMPLE MANAGEMENT

DATA ENTRY

21

KPIS - PROCESS CONTROL SAMPLE MANAGEMENT

DAILY DASHBOARD

22

KPIS - PROCESS CONTROL SAMPLE MANAGEMENT

URGENT REQUESTS

23

KPIS - PROCESS CONTROL QUALITY CONTROL

Quality control (QC) processes - part of process control,
able to be centrally monitored across all laboratories within
each State
QC monitors activities related to the examination (analytic)
phase of testing, directly to single operator level
The goal of QC is to detect, evaluate, and correct errors due
to test system failure, environmental conditions or operator
performance, before patient results are reported.
Long-term monitoring of internal quality control results to
assess method performance by detecting drifts or shifts in
performance.

24

KPIS - PROCESS CONTROL QUALITY CONTROL CONT.

25

KPIS - PROCESS CONTROL QUALITY CONTROL CONT.

PERIPHERAL/REGIONAL LABORATORIES URT AFFILIATE GROUP
REVIEW
SDI>2.0 from affiliate group

Month/Year

Laboratory

Test

Instrument

QC

ALT

AU480_2

Unassayed Chem

94.39

99.06

2.05

Beleura

Chloride

AU480

Unassayed Chem

99.31

101.5

2.21 Refer to Qpulse 15/9359

Shepparton

HDL

AU480

Unassayed Chem

0.735

0.8

2.57

Trig

AU480

Unassayed Chem

2.09

1.99

-2.06

Warrnambool

HDL

AU480_1

Unassayed Chem

1.77

1.91

Sale

Cholesterol

AU480_2

Unassayed Chem

2.91

2.8

-2.03

Sale

Digoxin

AU480_2

Unassayed Chem

1.61

3.88

5.67

6.06

Feb-16 Warragul

Level

ALM

ILM

SDI

Action

Each laboratorys
performance
monitored on a
monthly basis by
comparison to peer
laboratories within
Dorevitch Pathology
network

2.24 Refer to Qpulse 15/9087

3.3

Sale

Tbil

AU480_2

Paed

257.6

271.8

2.13 Refer to Qpulse 16/9927

Camperdown

GGT

AU480

Unassayed Chem

37.67

36.34

-2.17

159.5

154.4

-2.32 Refer to Qpulse 16/9887

Traralgon

Vanco

AU680_1

Unassayed Chem

45.01

47.07

2.03

Bairnsdale

Potassium

AU680

Urine 64380

30.87

32.33

2.58 Only 7 data points - QC lot number changed on 8/2/16. SDI for lot 66720 is 0.78.

26

KPIS - PROCESS CONTROL QUALITY CONTROL CONT.

Effective use of QC software

capabilities to control testing
processes effectively as relates to
long-term performance

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KPIS - PROCESS CONTROL PROFICIENCY TESTING

PT participation is valuable only if the information received is directed to improvement in
the laboratory.

A single unacceptable result does not necessarily indicate that a problem exists in the laboratory.

Mandatory enrolment for all testing disciplines

participation frequency on a bi-weekly or monthly
basis, depending on the testing discipline
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KPIS LABORATORY QUALITY COMPLIANCE

29

COST OF QUALITY
The cost of not creating a quality product or service

30

COST OF QUALITY CONT.

[Link]
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COST OF QUALITY CONT.

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COST OF QUALITY CONT.

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CONTINUOUS IMPROVEMENT
Information gathering must lead to change in a continual
improvement process.
Key Performance Indicators described previously
Incident or Occurrence Management analysis of non-conforming
events
Audits and Assessment performance on internal audits and
external assessments
Proficiency Testing/Long-term QC Review

Feedback and Complaints clients and staff

Any other source that suggest a difference between
client expectations and laboratory output

34

LABORATORY MODEL FOR OPERATIONAL

EXCELLENCE
Requirements:
Sound business strategy aligned with operational capabilities
Strategy executed consistently and reliably, on an ongoing basis, i.e.
sustained delivery that leads to continued excellence

= Operational Excellence

Operational Excellence is evidenced by results:

Lower operational risk

Lower operational cost

Increased revenues

Operational Excellence manifests itself through integrated

performance across risk, revenue and cost. i.e., sources of value
35

SOURCES OF VALUE 7 VALUE DRIVERS

Demonstrating
Operational
Excellence
through
superior
performance
across all 7
value drivers is
the result of
both being
operationally
excellent and
having a sound
business
strategy.
[Link]
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7- ELEMENT OPERATIONAL EXCELLENCE MANAGEMENT SYSTEM (OEMS)

[Link]
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FINITE CAUSES OF FAILURE

PEOPLE

Unaware of
Expectation

Expectations
don't Exist

Expectations
not
Communicated

Unable to perform as
Expected

Expectations
not
Reinforced

Lack of
Knowledge

Lack of Talent

Chooses not to perform

as Expected

Lack of Virtue

Wrong
Incentive

Once the causes of failure are identified, implement Key Controls:

Prevent failures; lessen impact if they do occur, e.g.

Maintenance and testing equipment SOPs ensure expectations exist

Audits and assessments enforce expectations

Training and competency assessment programs ensure staff have sufficient

knowledge
One Key Control may help address several causes of failure
One Cause of Failure may require the support of multiple Key Controls
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7 - ELEMENTS OPERATIONAL EXCELLENCE

MANAGEMENT SYSTEM (OEMS) CONT.

Leadership Committed leaders actively

demonstrate support achieving Operational
Excellence
Employee Accountability Employees must
know what they are accountable for, take
ownership and be held accountable
Risk Identification Once leaders and employees
understand their roles in preventing risk, identifying
those risks creates value
Risk Control With risks identified and assessed,
the means for controlling them can be identified
and implemented
Knowledge Sharing Consistent application of
controls are in place across the business before
employees can be trained on them and cross
functional knowledge and understanding can be
shared
Management of Change Processes must be
clearly defined and controlled before change can
be effectively managed
Continuous Improvement - Assessing and
attempting to improve a process that is out of
control creates little or no value
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[Link]
[Link]

CONTINUOUS IMPROVEMENT - PDCA

Plan Established & prioritized goals, targets & objectives are incorporated in to business planning
and budgeting processes; plans are developed to implement changes, processes, etc. to achieve
those goals. Identify the problems and the potential sources of system weakness or error. Decide on
the steps to be used to gather information. Ask the question, How can you best assess the current
situation and analyze root causes of problem areas? Using the information that is gathered through
these techniques, develop a plan for improvement.
Do Execution of the plans developed to achieve goals, targets & objectives; implement whatever
plans have been developedput the plan into action. Most of your teams time should be spent in this
step of the PDCA cycle planning and reviewing performance are important steps, but it is only
through doing that you will be able to 1) achieve your objectives and 2) learn about your processes &
organization to drive continuous improvement.

40

CONTINUOUS IMPROVEMENT - PDCA

CheckRefers to the monitoring process. Assess the effectiveness of the action taken, using focused
review and audit processeson the progress of the plans towards achieving their goals; generally key
metrics, audit findings, project timeline tracking, etc. will be collected. If the system weakness is
complex, a pilot study may be needed in order to understand all the complexities. After checking,
revise the plan as required to achieve the improvements needed.
Adjust/Act Overall effectiveness of the plans is assessed (typically through a Management Review
process with broad visibility of projects & performance across the organization); opportunity to learn
from what does/does not work, results that differed from expectations & lessons learned from
implementation team. Take any corrective action that is required, and then recheck to be sure that the
solution has worked. This cycle is a continuous process, so the laboratory will begin again with a
planning process to continue the improvements to the path of workflow.

41

IN SUMMARY
Quality is not a succinct science; it is a way of thinking. Operational
Excellence can only be achieved by achieving excellence in each of
the 7 OEMS Elements.
The regular application of the PDCA cycle to each of the Elements to
drive continuous improvement is the only proven, reliable means to
drive excellence. Any time invested will help towards gaining quality
results, peer recognition, and professional and personal satisfaction.
It is also important to note that the PDCA cycle is not a separate activity
or project. The 7 Elements should drive your business planning &
operations, and the PDCA cycle needs to be integrated in to those
activities.
All levels of personnel in the laboratory are responsible for quality
performance.
Laboratory leadership and managers must be committed to meeting
quality needs.
Laboratory personnel must follow all quality assurance procedures and
adhere to requirements and standards.
42