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

•‘24 hour cover’

Effective use of POCT

Patient Safety

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?

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

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?

96%

2%2%

Yes

Unsure

No

110 respondents

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

IM Barlow Ann Clin Biochem 2009; 46: 85–86

73

91

0

10

20

30

40

50

60

70

80

90

100

GP Nurse Practitioner

Per

cent

age

Percentage feeling comments (very) frequently helping/influencing patient management

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 2009Housley D & Freedman DB. ‘

• Outpatient referral

• MRI

• Patient experience of an incorrect pathological diagnosis

“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

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 (%)

All patient results electronically available to GPs through single access point regardless of requestor within cluster 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 24-48 hours in most cases 90

Electronic ordering systems linked to sampling centres and laboratories 80

ConclusionConclusion• 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 PathologyPatient Safety and PathologyPre Analytical right test

right patientright label‘request form’right sample

AnalyticalEQAAccrediation (CPA)

Post Analytical right resultright patientright clinicanright communicationright interpretationright Mx and further investigations

right labright conditions - temperature

“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)

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?”

“How confident are you in requesting laboratory tests?”

0% 20% 40% 60% 80% 100%

Urine sodium andosmolality

Short Synacthen Test

PTH

Haematinics

Mg, PO4

Proteins

U & E

LFT

Confident

Usually Confident

Not Confident

“How confident are you on interpreting laboratory tests?”

“How confident are you on interpreting laboratory tests?”

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Urine sodium andosmolality

Short Synacthen Test

PTH

Haematinics

Mg, PO4

Proteins

U & E

LFT

Confident

Usually Confident

Not Confident

Labs Are Vital™ Media Monitoring and Successful Results

What points in the process have the highest incidence of errors?

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 Relative Frequency (%)

Pre-pre-analytic 46 – 68.2

Post-post-analytic

25 - 45.5

Plebani M Ann Clin Biochem 2010, 47: 101-110

Post-post analytical errors: frequency of incorrect interpretation of diagnostic tests in different clinical settings

Setting Primary Internal Emergency care medicinedepartment

Incorrect interpretation of diagnostic tests: estimate (%)

37 38 37

Plebani M , Ann Clin Biochem 2010 : 47 101-110

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 Accident and Acute Medical emergency department admissions

ward (n=3228) (n=1836)

Within 1 hour 794 (25)% 412 (22)%

1-3 hours 491 (15)% 341 (19)%

Over 3 hours 500 (15)% 553 (30)%

Never 1443 (45)% 529 (29)%

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 169.1123-9

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”

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

A Way Forward:

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 InterfaceRole of Laboratory Interface

48 year old male

GP routine bloods

Grossly lipaemic – triglyceride = 130 mmol/l (<1.9)

Clinical Vignette

DBF D/W GP – known alcoholic ? Risk of pancreatitis (from etoh and trigs)Commence ciprofibrate 100 mg odCease etohSuggest referral ASAP to hepatologist

Avoidance of acute admission and potential morbidity

Clinical VignetteClinical Vignette

TSH inappropriate for fT4 – lab add other Ix

Sodium = 128 mmol/l Other U&E NAD

Cortisol (08:30am) = 108 nmol/l Prolactin 167 mU/l

Testosterone = 2.9 nmol/L LH = 1.9 U/l, FSH = 2.8U/l

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

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.

• 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

Clinical VignetteClinical Vignette

• 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 VignetteClinical Vignette28 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/lCreatinine = 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 40mgGP 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 cirrhosisCost 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

Multi-disciplinary investigation strategies agreed between users and diagnostic departments save clinician time and reduce variation.

For use in Consultant led hepatology or gastroenterology clinics only. Requests from other sources will be reviewed and may be rejected.

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

Email linked to reports offers an additional way for clinicians to seek clinical advice from

the laboratory. Lab advice automatically enters medical record.

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 yesterdaySarah

Clinical letters linked into lab system enable clinical scientists / pathologists to have extensive clinical / drug information available to improve reporting

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

DOES A TICK BOX CULTURE EXIST ?

2009

ICE introduced

2010

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

0

10

20

30

40

50

60

70

80

90

Improvedservicedelivery

Benefitspatients

Benefitsusers

Improveslab

reputation

Improvessafe +

reliability

DOH shouldRegulate for

CPAcompliance

DOH should consider

Regulatory requirement for

Compliance with CPA standards.

Improved pathology service delivery

Benefited patients

Benefited users

Improved the pathology services

reputation

Ensured that pathology

Results are safe and reliable

Views on CPA by hospital pathology users –

Luton and Dunstable Hospital 2009

Effective use of Point of Care Testing (POCT)

Effective use of Point of Care Testing (POCT)

Hospital ‘Chemists’

Surgicentres Home

Polyclinics ‘other’ eg internet, van

GPs

Paramedical vehicle

World-wide PoCT Market

US $2.8 billion $5.5 billion

Outside US $2.6 billion

World-wide $5.4 billion $10.3billion

2001 2005

2011 - $18.7 billion global, $7.5 billion US

Applications of POCTApplications of POCTThe Evidence – Clinical and/or cost effectiveness*

Some examplesInfection eg CRP*

Helicobacter Pylori?Chlamydia?Urine leukocyte*

Chronic Disease DM HbA1C*

Management Hyperlipidaemia Cholesterol*Anticoagulation INR*Hypertension Albumin:cr?CHD BNP*

Acute U + E*Gases*Troponin*

Cost benefits of POCT anticoagulation management in Primary Care

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 POCTImplementation of POCT

POCT is presented as

“Easy to use and capable of producing accurate results ....”

but

• 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

Problems (RISK MANAGEMENT) when procedures for training and quality assurance are poor

Case HistoryCase HistoryMiss DM, 28 year oldMarch ‘mild glycosuria’GP performed GTT:

Time0 mins30 mins60 mins90 mins120 mins

8.418.622.015.212.3

Glucose (mmol/l) - glucometer

Rx: Glibenclamide

Revisited GP - symptoms of hypoglycaemiaGlibebclamide stoppedSeptember referred to Diabetic clinicGTT (laboratory)

Time0 mins60 mins120 mins

Glucose (mmol/l)5.35.36.1

Glucometer - faultyNo QC

• > 3200 incidents including 24 deaths and 986 injuries have been filed with FDA re blood glucose monitoring

In US

Successful POCTJoint endeavor

… failure of professionals to indicate to top management the clinical risk involved

(Burnett Ann Clin Biochem 2000)

• Manufacturers• Many different professional groups• Patients

Regulation of POCTRegulation 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)

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 ?