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QUALITY MANAGEMENT
As at 30 June 2015
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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
~
~
~
~
100%
Pathology / Clinical
Laboratories Division
~
~
~
~
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
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
Summary
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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
* CLSI QMS01-A4
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*CLSI QMS01-A4, Quality Management System: A Model for Laboratory Services; Approved Guideline Fourth Edition
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Request
Review
Patient
Identification
& Consent
Phlebotomy/
Self
Collection
Specimen
Collection
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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
OPERATIONAL INDICATORS
Patient Statistics
Doctor Statistics
Collection Centre
Statistics and Collector
Workload
Occurrences (including
complaints)
PRE-ANALYTICAL INDICATORS
Request Form Errors
Incorrect Collection
Recollection Rates
Transport Temperature
Failures
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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
POST-ANALYTICAL INDICATORS
Report Delivery Errors (via client feedback)
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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%
17
35
6%
Unlabelled Specimen
14
14
3%
No Collector's Declaration
1%
Haemolysed Specimen
37
5%
15
2%
Unsigned Specimen
1%
Other
64
37
11%
Total:
461
454
100%
Recollection Site:
Total
684
138
149
18%
7%
FBE
5%
4%
EUC
ESR
COA
10%
8%
Citrate
tube
Urine
(MSU)
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
-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
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23
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25
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
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
3.3
Sale
Tbil
AU480_2
Paed
257.6
271.8
Camperdown
GGT
AU480
Unassayed Chem
37.67
36.34
-2.17
159.5
154.4
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.
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A single unacceptable result does not necessarily indicate that a problem exists in the laboratory.
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COST OF QUALITY
The cost of not creating a quality product or service
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http://asq.org/learn-about-quality/cost-of-quality/overview/overview.html
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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
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= Operational Excellence
Increased revenues
https://www.scribd.com/doc/161609767/Achieving-Operational-Excellence-in-theFace-of-Complexity#fullscreen/
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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
Lack of Virtue
Wrong
Incentive
http://www.wilsonperumal.com/blog/category/healthcare
https://www.scribd.com/doc/161609767/AchievingOperational-Excellence-in-the-Face-ofComplexity#fullscreen/
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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.
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