validation lecture l.. - Lab Manual - Laboratory Manual for laboratories

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Brain to Brain Cycle
Dr. Bill Bartlett
Consultant Clinical Scientist
Dept Clinical Biochemistry & Immunology
Heart of England NHS Foundation Trust
Birmingham B9 5SS
Bill.Bartlett@heartofengland.nhs.uk
Our Business: -
Information
Management
Measurement
Knowledge
Management
Importance of Laboratory
Medicine

70 to 80% of decisions in diagnosis based on
laboratory outputs.

70 – 80% of the interactions of health care
professionals involve laboratory outputs.
Our Work and the Quality of Our Work
Under pins the Delivery of High Quality
Health Care
What do we do for a living?

We save lives.
 We help diagnose, monitor & treat disease
 We screen for disease
 We carry out and support R&D
 We teach
How do we do these things
We Use Our Brains &
Help Others User use
Theirs
We Measure
We Use Our Brains &
Help Others User use
Theirs
Brain to Brain Cycle
Bill.Bartlett@heartofengland.nhs.uk
What Is It?

Phrase was first used by George Lundberg
in the context of laboratory testing.
– (JAMA 1981:245:1762-1763)

Refers to a process that ideally links a
clinical problem to an appropriate action,
taken on the patients behalf, based on the
results of laboratory tests.
 Question - Answer - Interpretation -Action.
Knowledge
Appropriate
Post-analytical
Processes
Appropriate
Analytical
Processes
Information
Processing &
Flow
Data Integrity
Appropriate
Pre-analytical
Processes
The Process: •Ask the right questions.
•Interpret the answers.
•Collate the information.
I don’t feel well Doc!
•Arrive at working diagnosis.
What is the nature and
•Request: cause of his disease?
•Pathology
•Radiology
•Other Opinions
•Admit?
•Wait
?
Output
•Information
•Questions
Analytical
Pathology: Phase
Request
INPUT
•Information
•Samples
to Result
What is the Process
Request
Sample
Transport
Pre Analytical
Analytical
Validation
Interpretation
Report
Apply Output
9 Steps
Phases
Pre - Analytical
Analytical
Post -Analytical
Value in Understanding the Cycle
 manage

the process to reduce complexity.
remove the choke points, consolidate and
automate
 become
pro-active in helping clinicians
to: use the laboratory services appropriately.
 use the product of the process which is
information.

How will managing the cycle impact on
healthcare?

Delivery of a more efficient diagnostic
process: – better targeting of resources
– shorter bed stays?
– faster processing of patients?
Brain to Brain Cycle
•Complex.
•Applies to every request
•Every cycle results in costs outside of
pathology (e.g. longer bed stays?)
• Any error reinitiates cycle
• Information flows and accuracy are
critical.
•Complex analytical processes = time
• Repeat cycles = cost!
• Need to use information generated.
Failure to do so = unnecessary cost
• Wrong results or misinterpretation
= cost
Managing the Cycle
How do we dispose of the complexity
and increase effectiveness?
•Understand Process and simplify
•Intelligent Requesting
•Deal with the Analytical Aneurysm.
•Direct skills into value added
processes.
Diagram Courtesy of Dr CG Fraser, Dundee
•Provide informative reports, to
the right place, in the right time
frame.
Requesting & Reporting
The Key to a Patient Focus?

Need to help users: – Ask the right questions.
– Provide the right inputs.
– Apply the outputs effectively.

We need to: – deliver the required outputs to the right
place within the required time frame.
To Be Effective We Need To
Ensure That: 
the correct questions are asked.
 the correct inputs are provided.
 valid analytical processes are applied.
 useful outputs are delivered in an
appropriate time frame.
 our outputs are applied effectively.
Asking the right questions.


Requestors have varying degrees of
knowledge, experience, expertise.
(Nurse/Pharmacist/Doctor).
Tools: –
–
–
–
Brain - limited capacity/ exposure
Books, Journals - Volume
Protocols (NSFs) - Volume
Triage systems – Presentation panels (Headache,
gut ache etc, chest pain)
– Expert systems

Additional inputs, previous results, Hx, Rx
User Education

Less emphasis on laboratory medicine in
medical curricula
 Exponential rise in the size medical
evidence base.
 Fewer people with increased demands on
their time.
More protocol driven processes required?
Evidence into practice?



Job of the lab
medicine specialist
to work with
clinicians to turn
evidence into
practice.
Take the evidence
and build it into the
requesting interface.
Integrate systems
with expert systems
Electronic/Intelligent
Requesting








Accurate flows of information.
Time efficient.
Linking requesting with results.
Linking requesting with care pathways.
Ability to see outstanding requests.
Building in protocols and links to information
sources.
Enable the partially informed requestor.
Closing the loop between electronic systems.
Brain to Brain Cycle
Bill.Bartlett@heartofengland.nhs.uk
Big Expensive User
And for my next
request, I would
like to tick all the
boxes.
What’s in a Request?

Decide what is to be measured

Decide in what sample to measure it, (blood,
urine, faeces, tissue, CSF, etc)

Apply knowledge about the stability of the
analyte (requirement for sample stabilisers,
preservatives, cold transport etc)

Decide where to sample from (e.g. arterial versus
venous sampling,
identify infections)
swabs from which areas to
What’s in a Request?

Identify the most appropriate time to take the
sample (knowledge of biological rhythms,
effects of drugs on analysis, effects of feeding
on analytes (e.g. blood glucose))

When to involve and inform the people who
know how to measure the analyte

Initiate the request for analysis

Take the appropriate samples

Ensure that the samples and relevant
information are passed to the laboratory
Phases
Pre - Analytical
Analytical
Post -Analytical
G
T
E
P
A
S
Ward
Work
Station
PAS
Hard Copy &
Bar code
NHS No, DoB
Name
Intranet/Web
P
a
t
h
o
l
o
g
y
0
1
Pathology 01 Ice
Server
Lab
Work
Station
Requesting Module
SQL Requests
Hard Copy &
Bar code
PDF
SQL Results
Web/VPN
GP
Work
Station
FTP
TELNET
T
e
l
e
p
a
t
h
Cell Path
Blood Bank
Microbiology
Chemistry
Immunology
Haematology
Hard Copy &
Bar code
GP Clinical
System
ICE Client
Phases
Pre - Analytical
Analytical
Post -Analytical
Pre-analytical Phase

Critical Phase
 Garbage in Garbage out
 Labour intensive
 Complex Processes
– Errors
– Choke Points

Automation
Automation
Phases
Pre - Analytical
Analytical
Post -Analytical
Current Capacity

Heartlands: 6800/hr Chemistry 340/hr immunoassay:
-
*3600 electrolytes /hr
*3200 photometric test/hr
*22- 44 reagent slots per P800
*340 tests/h
*up to 340 samples/h
*50 reagent channels (slots)
Solihull: 1700/hr chemistry, 170/hr immunoassay:
-
SWA/ Modular PE
ISE 900/1800 module
 ISE tests (Na, K, Cl)
 ISE 900: up to 900 tests/h
P 800 module
 Photometric tests
 Throughput: up to 800 tests/h
 22-44 channels, (reagent slots)
 flexible setting
E 170 module
Immunology, ECL technology
Throughput:up to 170 tests/h
25 channels (reagent slots)
Mass Spectrometry
Near Patient Testing
What is acceptable performance?
 Accuracy
 Imprecision
– Short/Long term
 Within lab/between lab
 Within organisation
 Turn
around time
 Failure rates
Fitness for purpose: How do you assess this?
 Analytical Goals
 Method design and validation against goals
– Analytical goals
– Clinical decision limits
– Reference change values


Practicability
Process design and validation against goals
Phases
Pre - Analytical
Analytical
Post -Analytical
Apply Outputs Effectively.

Combine information, data and knowledge to provide a
meaningful report to the point of care.

Enriched reports to aide medics.
– Disease probabilities based on nosology
– Graphical representations
– Novel reporting formats based on pattern
recognition?
– Hyperlinks to data sources decision aides.
– Automatic referral to areas of expertise
(local/national)

Information for patients.
Pacific Knowledge Systems

www.pks.com.au.
 Tailors the report to the patient
Request
Sample
Transport
Pre Analytical
Analytical
Validation
Interpretation
Report
Apply Output
Traditional focus of
laboratory systems
Request
Sample
Transport
Pre Analytical
Analytical
Validation
Interpretation
Report
Apply Output
New systems
functionality will
address these areas and
more (e.g.): • Integrated lab handbooks
• Logistics planning/ordering
• Integration with expert
systems
• Billing
• Document control
• Data mining
• Knowledge and information
management
• Surveillance
• Audit
Web Enabled.
The Beginning
Or
The End
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