Creating value and improving patient
safety – the role of the Lab
Professional
Dr Danielle B Freedman
FiLM Feb 2011
Q1
• What do users want from a lab service –
• Top10 aspects
What do users really want?
Role of Laboratory interface
• Value of interpretative service
• ‘Demand management’
inappropriate testing/non testing
Patient
• ‘24 hour cover’
Safety
Effective use of POCT
The Problems
• Too many tests
• Different names
• Different units
• Different reference intervals
• Different alert limits
• Inconsistent guidelines
•
•
•
•
•
•
•
What do our users want
from Laboratory Medicine?
Information to allow clinicians to make better
decisions about patients
Patient safety
Clinical governance, accountability, accreditation
Demand management. Investigations need to
becheap, quick and correct. “New” tests
Right investigation on the right patient at the right
time
Result needs to get to the right clinician at the right
time using the right medium
Right interpretation and right patient outcome
What interests Practice Based
Commissioners
•
•
•
•
•
•
Care Closer to Home eg Warfarin monitoring
Care pathways and pathology tests eg eGFR and
Primary Care management of chronic kidney disease
Collection of specimens and electronic reporting of
results
Need to establish clinical dialogue with laboratories
Development of Point of Care Testing
Patient safety
J Crockett CEO, Wolverhampton City PCT 2008
• Consolidation
• Diagnostics “nearer the home”
• Diagnostics provided by ‘others’
? Fragmentation of service
Primary Care Clinical Advice
Questionnaire S Beds 2009
Q. Did Clinical Advice on Interpretation aid in
patient management?
2%2%
Yes
Unsure
No
110 respondents
96%
Comments:
‘Particularly useful in obtaining advice when
testing for endocrine disorders’
‘A1 Service’
‘GP provider link is excellent’
‘Knowing there is someone to ask can save
inappropriate investigations & unnecessary
referral’s’
‘Dr Freedman very helpful & always return calls
promptly’
Are endocrine comments useful to GPs?
IM Barlow Ann Clin Biochem 2008; 45: 88–90
TFT comments affecting patient
management
100
91
90
80
73
Percentage
70
60
50
40
30
20
10
0
GP
Nurse Practitioner
Percentage feeling comments (very) frequently helping/influencing patient
management
IM Barlow Ann Clin Biochem 2009; 46: 85–86
Objective evidence of the benefit of
interpretative comments
Provision of interpretative comments to GPs has
led to:
• 22% reduction in inadequate thyroxine
replacement in samples from hypothyroid
patients
• ~500 more patients adequately treated after
introducing comments
Kilpatrick Ann Clin
Biochem.2004:41:225-7
Getting the most from your Pathology Lab’
National Association of Primary Care Review April
2009
Housley D & Freedman DB. ‘
“Emphasis on laboratory role on interpretation … computer
generated comments according to predetermined rules;
comments on reports or by dialogue at bedside or by phone
…”
e.g.  PRL
Reflex testing - Macroprolactin Comment
Avoids • Outpatient referral
• MRI
• Patient experience of an incorrect pathological
diagnosis
Survey of East of England GP Commissioning
Groups
Please score the issues below, indicating their
importance to you and your practice
All patient results electronically available to GPs through
single access point regardless of requestor within cluster
Important or
Very
Important
(%)
100
Reduction in unit cost of tests
90
Specialist support for GPs from pathologists within cluster
for pre-analytical and post-analytical phases
80
Monthly utilisation and cost data at GP level to analyse
usage and inform commissioning decisions
90
Support the implementation and maintenance of POCT
systems in primary care
80
Survey of East of England GP Commissioning
Groups
Please score the issues below, indicating their
importance to you and your practice
Important or
Very
Important
(%)
Accessible and convenient sampling centres which include
support for extended GP working and out-of-hours
70
Guaranteed sample collection times throughout the day,
maintaining ample integrity
100
Guaranteed raid and consistent turnaround times, within 2448 hours in most cases
90
Electronic ordering systems linked to sampling centres and
laboratories
80
Conclusion
•
•
•
•
•
•
•
Pathology and laboratory services need to become
more ‘dynamic’ and responsive to needs of
patients, 1° care clinicians and commissions
Community pathology services should receive
higher profile in commissioning and need dialogue
PBC, PCTs and pathologists
Improve access to phlebotomy
Test ordering – education and training and
feedback or behaviour, clinical guidelines
Accreditation – governance infrastructure
POCT
Patient Safety
Q2
• What points in TTP have highest
incidence of errors ?
Patient Safety and Pathology
Pre Analytical
right test
right patient
right label
‘request form’
right sample
Analytical
EQA
Accrediation (CPA)
Post Analytical
right lab
right conditions temperature
right result
right patient
right clinican
right communication
right interpretation
right Mx and further investigations
“patients who are acutely ill
are often cared for by most
junior medical staff who
have least knowledge and
experience”
BMA News, 2 June 2007
(letter)
T-bone stake
“…It reminded me of the occasion when a FY2 rang while
I was on call to inform me that he had seen a patient with a
broken forearm – but did not know the anatomical name for
the bone. At a guess it started with the letter “T”, he said.
I dashed to the patient’s side to clarify that the patient had
actually injured what I was envisaging and was in no
danger.
The FY2 had never sat a formal anatomy exam, nor had
he undergone formal dissection/pro-section lessons at
medical school…”
“How confident are you in
requesting laboratory tests?”
LFT
U&E
Proteins
Mg, PO4
Confident
Usually Confident
Not Confident
Haematinics
PTH
Short Synacthen Test
Urine sodium and
osmolality
0%
20%
40%
60%
80%
100%
“How confident are you on
interpreting laboratory tests?”
LFT
U&E
Proteins
Mg, PO4
Confident
Usually Confident
Not Confident
Haematinics
PTH
Short Synacthen Test
Urine sodium and
osmolality
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Labs Are Vital™ Media Monitoring and Successful Results
What points in the process have the
highest incidence of errors?
Bar coding?
Specimen collection?
Specimen Analysis?
Results reporting?
NO
Laposata 2008
What points in the process have the
highest incidence of errors?
Test selection by clinicians?
Interpretation of test results by
clinicians?
YES
Laposata,2008
Types and relative frequency of errors in the
different phases of the TTP
Phase of the TTP
Pre-pre-analytic
Post-postanalytic
Relative
Frequency (%)
46 – 68.2
25 45.5
Plebani M Ann Clin Biochem 2010, 47: 101110
Post-post analytical errors: frequency of
incorrect interpretation of diagnostic tests in
different clinical settings
Setting
Primary
Internal
care
Emergency
medicine
department
Incorrect interpretation
of diagnostic tests:
estimate (%)
37
38
37
Plebani M , Ann Clin Biochem 2010 : 47 101110
Safe care measures
“avoiding injuries to patients from the care that is intended to help them”
AUS
CAN
GER
NL
NZ
UK
US
Overall rank
6
5
2
1
4
2
7
Medication
errors
13%
10%
7%
6%
13%
9%
14%
Incorrect lab
test result
7%
5%
5%
1%
3%
3%
7%
Delay in
notification of
abnormal
results
13%
12%
5%
5%
10%
8%
16%
Commonwealth Fund, 2010
“No point in requesting a test if no-one looks at
the results and/or acts on the result…”
Kilpatrick and Holding BMJ 01
Delay
ward
Accident and
emergency department
(n=3228)
Acute Medical
admissions
(n=1836)
Within 1 hour
(22)%
794 (25)%
412
1-3 hours
(19)%
491 (15)%
341
Over 3 hours
(30)%
500 (15)%
553
Never
(29)%
1443 (45)%
529
Of 1443 A & E results – 43 (3%) could have led to an immediate change in management
Audit of Emergency Department at the Luton &
Dunstable Hospital:
Results reported and reviewed for a 24 hour period
Results not reviewed within one hour
50%
[of which 89% were outside reference interval]
Not within 2 hours
26%
Not within 3 hours
14%
Not at all
10%
17 Feb 2010
Disconnect between Lab Alerts & Follow
Up Singh et al. Am J Med 2010: 123:238-244
Out Patient results May – Dec 2008
Hb Aic
≥ 15%
positive hepatitis C antibody
PSA
≥ 15 ng / ml
TSH
≥ 15 MU / l
10.2% of alerts unacknowledged
‘Multidisciplinary interventions involving human – computer interaction
and highly reliable tracking systems to monitor test result notification
outcomes are needed to alleviate patient safety concerns’
Frequency of failure to inform patient of clinically
significant outpatient test results
Failure to inform outpatients of significant abnormal test
results
1 in 14 tests
e.g.
Cholesterol =
8.3mmol/ L
Potassium
2.6 mmol / L
=
Casalino et al Arch Int Med: 2009 169.11239
Critical Value Reporting
ISO EN15189 :2007
… “ immediate notification of a critical value is a
special requisite”
CPA (UK) Ltd
… “ critical value reporting is essential to ensure
Quality of diagnostic laboratory services”
Joint Commission NPSG 2010
... “report critical results on a timely basis”
A Way Forward:
Critical Value Reporting
Need for consensus critical values list
Surveys for comparing and improving
existing
policies regarding critical
values should be promoted at an
INTERNATIONAL LEVEL
Piva, Sciacovelli, Plebani &
Laposata
Clin Chem Lab Med 2010: 48:461-8
Q3
• Top 10 Quality Indicators, in general terms
“What is Quality in Pathology”
12/13th Oct 2010
• www.rcpath.org/resources/pdf/rcpath_quality_meeting_draft_13.pdf
• RCPath response to Ian Barnes letter “Reconfiguration
of NHS Pathology Services “ July 2010
Q4
• Egs of Pre and Post analytical input has
made a difference to patient outcome
• ( excluding cell path/morphology/antibiotic
sensitivity)
Role of Laboratory Interface
Clinical Vignette
48 year old male
GP routine bloods
Grossly lipaemic – triglyceride = 130 mmol/l
(<1.9)
DBF D/W GP – known alcoholic
? Risk of pancreatitis (from etoh and trigs)
Commence ciprofibrate 100 mg od
Cease etoh
Suggest referral ASAP to hepatologist
Avoidance of acute admission and potential morbidity
Clinical Vignette
56 year old Chinese male (poor historian)
Previous A&E attendance with 1/52 headache – given some medicine
Since then generally unwell – sweating, ? Weight loss
GP requested TFT – fT4 = 6 pmol/l, TSH = 1.23 mU/l
TSH inappropriate for fT4 – lab add other Ix
Sodium = 128 mmol/l
Other U&E NAD
Cortisol (08:30am) = 108 nmol/l
Testosterone = 2.9 nmol/L
Prolactin 167 mU/l
LH = 1.9 U/l,
FSH = 2.8U/l
Hydrocortisone cover advised, followed by replacement of other axes
– Urgent Chemical Pathology OPD arranged with GP. Infarcted
pituitary adenoma confirmed. Avoidance of acute admission and
potential morbidity.
Clinical Vignette
•
•
•
•
Patient presents to GP with bruising and nose bleeds
Platelet count <20
Consultant haematologist speaks to GP to start
Prednisolone immediately at 7pm on Friday
- prevent inpatient admission and potential morbidity
Microbiologist authorising reports 2 children with
MRSA from swabs collected for ?otitis externa
Both patients from same surgery seen 2 hours apart
Discussion with GP revealed insufficient attention to
cleaning ear pieces and issues around hand hygiene
“Before ordering a test, decide what you
will do if it is either positive or negative,
and if both answers are the same, then
don’t do the test!”
Reference ranges
Factors influencing the result
Interpretation
Further investigations
‘Delivery’ of results
Clinical Vignette
28 year old male
GP requests routine investigations at 6pm Friday night,
processed in lab at 7pm:
Sodium = 116 mmol/l (136 – 148)
Potassium = 1.9 mmol/l (3.8 – 5.0)
Urea <0.3 mmol/l
Creatinine = 81 mol/l
Only clinical details available ‘alcoholic’
? Beer potomania
Emergency admission arranged by DBF via GP
45 year old female
Cholesterol 8.2mmol/L despite being on Simvastatin 40mg
GP phoned Clinical Biochemistry
Comment:
• Exclude secondary causes of hypercholesterolaemia
• Liver tests demonstrated
ALP = 350 IU/L [25 – 120]
• Prior to starting Statin
ALP = 340 IU/L
• Further investigations:
Antimitochondrial antibodies , U/S Liver, Liver biopsy
Diagnosis:
Primary biliary cirrhosis
Cost to Purchasers?
Cost to patient?
Value to the whole health
economy?
Cost to the health economy
Outpatients:
New :
£200
F/U
£100
:
Admission Acute: £1150 + Market forces
16% Luton
30% + London
HDU :
£1000/ day + Market forces
ITU
£2000 / day + Market forces
:
Q5
• IT supporting the clinical role of the lab
For use in Consultant led hepatology or
gastroenterology clinics only. Requests from
other sources will be reviewed and may be
rejected.
Multi-disciplinary investigation strategies agreed between users and
diagnostic departments save clinician time and reduce variation.
Ordering by clinical condition with defined options for primary care reduce
inappropriate tests and reduce variation in practice.
Tests linked to diagnostic algorithms at time of order promote appropriate
investigations, ensure adequate investigation and improve compliance with
care pathways.
Electronic orders linked to patient information resources and evidenced based testing
websites
David I have never seen this written on a GAGS
report before what is the reason they have written
it here .This was an odd baby who behaved in a
slightly encephalopathic way and got cooled when
newborn .He has a persistently slightly abnormal
ALT and is mildly anemic .Otherwise now
asymptomatic when Sabine saw him yesterday
Sarah
Email linked to reports offers an additional way for clinicians to seek clinical advice from
the laboratory. Lab advice automatically enters medical record.
Clinical letters linked into lab system enable clinical scientists / pathologists to have
extensive clinical / drug information available to improve reporting
DOES A TICK BOX CULTURE EXIST ?
TEST
Gamma-GT
Phos
Mg
2007
3217
12857
13775
2008
3429
14745
15185
2009
4056
17463
17302
2010
4461
20199
19112
2011
2427
16907
15867
2009
2010
ICE introduced
Tick boxes removed
Laboratory automatically generate emails
within reporting system to alert people to key
results
• – numerous examples, but these include:
• All BNP > 200 pg/ml mailed to community heart failure
nurses who then organise rapid diagnostic echo –
reduces time to definitive diagnosis.
• All children less than 10yrs with a TSH > 10 IU/ml alerted
to paediatric endocrinologist – improves drug
compliance.
• All positive troponins mailed to cardiac team / rehab
nurses – ensures all inpatients obtain cardiology review.
System DOES NOT replace traditional alerting of critical results, but acts as a
supplement to improve outcome and care.
Q6
• Benefits of formal accreditation process of
Pathology
Views on CPA by hospital pathology users –
Luton and Dunstable Hospital 2009
Improved pathology service
delivery
90
80
Benefited patients
70
60
Benefited users
50
Improved the pathology services
40
reputation
30
20
Ensured that pathology
10
Results are safe and reliable
0
Improved
service
delivery
Benefits
patients
Benefits
users
Improves
lab
reputation
Improves DOH should
safe + Regulate for
reliability
CPA
compliance
DOH should consider
Regulatory requirement for
Compliance with CPA standards.
Effective use of Point of Care
Testing (POCT)
Hospital
‘Chemists’
Surgicentres
Home
Polyclinics
‘other’ eg internet, van
GPs
Paramedical vehicle
World-wide PoCT Market
2001
US
$2.8 billion
Outside US
$2.6 billion
World-wide
$5.4 billion
2005
$5.5 billion
$10.3billion
2011 - $18.7 billion global, $7.5 billion US
Applications of POCT
The Evidence – Clinical and/or cost effectiveness*
Some examples
Infection
eg CRP*
Helicobacter Pylori?
Chlamydia?
Urine leukocyte*
Chronic Disease
Management
DM
Hyperlipidaemia
Anticoagulation
Hypertension
CHD
Acute
U + E*
Gases*
Troponin*
HbA1C*
Cholesterol*
INR*
Albumin:cr?
BNP*
Cost benefits of POCT anticoagulation
management in Primary Care
P Johnson City + Hackney PCT (2008)
Net savings as result of transferring 460 patients
from 2° to enhanced service in GP practices
> £150,000 pa
but
O’Connor, (J Clin Path Feb 2008)
In Shropshire error rate for 1 practice 164 times
higher than hospital [INR>8]
Implementation of POCT
POCT is presented as
“Easy to use and capable of producing accurate results ....”
but
Problems (RISK MANAGEMENT) when procedures for
training and quality assurance are poor
•
•
•
Incorrect results can affect the well-being of a patient
Health hazards eg HIV and hepatitis viruses to both
patient and operator
Implementation MUST follow National Guidance
Case History
Miss DM, 28 year old
March ‘mild glycosuria’
GP performed GTT:
Time
0 mins
30 mins
60 mins
90 mins
120 mins
Glucose (mmol/l) - glucometer
8.4
18.6
22.0
15.2
12.3
Rx: Glibenclamide
Revisited GP - symptoms of hypoglycaemia
Glibebclamide stopped
September referred to Diabetic clinic
GTT (laboratory)
Time
0 mins
60 mins
120 mins
Glucose (mmol/l)
5.3
5.3
6.1
Glucometer - faulty
No QC
In US
•
> 3200 incidents including 24 deaths and 986
injuries have been filed with FDA re blood glucose
monitoring
Successful POCT
Joint endeavor
•
•
•
Manufacturers
Many different professional
groups
Patients
… failure of professionals to indicate to top
management the clinical risk involved
(Burnett Ann Clin Biochem 2000)
Regulation of POCT
•
•
•
•
•
•
•
UK: no legal framework but MHRA 2010
Belgium, Finland: legal framework
Netherlands: mandatory guidelines that regulate
laboratory testing, including POCT
Germany: legal framework for analytical quality
control
Italy: regional but not national guidelines
France: legal regulation of public laboratories but
not private labs (from report of Roundtable meeting,
Abbott 2005)
USA: POCT is regulated by CLIA federal law
(Thanks to Dr J Pearson, Leeds)
View from Mr Gordon Cropper, Chair of
Lay Advisory Committee RC Pathologists
(2007)
“…the members of lay committee
would rather have the correct/right
result and wait a couple of days, than
have a ? wrong result immediately…”
National Guidance
• ISO 15189 and ISO 22870
• National Guidance issued in 2002
• Clinical Pathology Accreditation
(UK) Ltd PoCT standards in 2010
• MHRA 2010
Q8
• In 3 years time do you think the value of
Lab testing will be :
•
•
•
•
a) more important than today ?
b) less important ?
c) the same
And WHY ?