Test Requisition vs

Test Request A transatlantic look at different approaches to

managing lab test utilization that improves outcomes and reduces costs

Dr Danielle Freedman MD Luton and Dunstable Hospital, Luton, UK

Dr Paul Kurtin MD Mayo Clinic, Rochester, USA

Executive War College, New Orleans, May 2015

Dr Danielle Freedman MD

Consultant Chemical Pathologist Associate Physician in Clinical Endocrinology

Director of Pathology Luton and Dunstable University Hospital

NHS Trust, UK

Nothing to disclose No relevant financial interests

Laboratory Test Requesting in UK

• Factors influencing test ordering by clinicians

• Strategies for modifying clinicians ordering patterns

• Implementing policies to improve laboratory utilisation and thereby improve patient outcome

Question 1

What most determines a clinician’s test ordering? 1. Fear of litigation 2. Cost of test 3. Evidence based guidelines 4. Patient went to Lab Tests Online 5. Watched an episode of ‘House’ last night

ACB SPOTLIGHT MEETING, UK OCTOBER 2012

Analysis of malpractice claims – US Ann Intern Med 2006; 145: 488-496

Faulty process leading to missed diagnosis: • Failure to order appropriate dx /lab test 55% • Inappropriate/inadequate follow-up 45% • Failure to obtain adequate history/exam 42% • Incorrect interpretation of diag. test 37% • Failure to refer 26% • Provider did not receive test results 13% • Tests ordered but not done 9% • Tests performed incorrectly 8%

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 be cheap, quick and correct. “New” tests

• Right test on the right patient at the right time

• Result needs to get to the right clinician at the right time, using the right communication

• Right interpretation and right patient outcome Getting it right first time

Question 2

How much is spent in the US on unnecessary testing and procedures ?

a. $ 1.5 billion b. $ 3.0 billion c. $ 6.8 billion

d. $ 18.0 billion

17.4 % of US GDP was spent on health care in 2009

$65 billion per annum on > 4.3 billion laboratory tests

Unnecessary testing

• Australia – Vit D requests increased by 4,600 % from 2002/3 to 2011/12 !!

• 73,000 requests pa to 3.5million requests pa

Vasikaran ,Ann

Clin Biochem 2013: 50: 283 - 4

In Vitro Diagnostic Costs per Capita $ [EDMA (European Diagnostic Manufacturer’s Association)2014]

Country IVD per capita ($)

United Kingdom 13.4 Germany 26.8 France 27.2 Italy 27.8 Belgium 31.6 Iceland 34.2 United States * 203.8

* Alexander, Critical Values 2012

Some Causes of Overutilization

• Patient pressure

• Duplicate requesting

• Lack of understanding of the diagnostic value of a test

– “just in case”

• Ordering ‘wrong’ test

• Failure to understand the consequences of overutilization

• Defensive testing

• Perverse financial incentives (more tests = more revenue)

• “Availability creates demand “

Consequences of Overutilization

• Increased resource utilization

• Incorrect diagnosis and treatment

• Incorrect test ordering delays diagnosis

• Increased length of stay

• Patient alarm

• Contribute to blood loss

SYSTEMATIC REVIEW:

In the US, extent of tests not followed up: anything up to 62% of lab tests and 35% of radiology reports

Callen et al,

Journal of General Int. Med (2012); 27 (10), 1334 – 1348.

Reviewing of results in ER at the Luton & Dunstable Hospital:

2010 2012 2014

Not reviewed within 1 hour 50% * 71%

Not reviewed within 2 hours 26%

Not reviewed within 3 hours 14%

Never reviewed 10% 10% 7.4%($140k)

* 89% were outside the reference interval

In the UK • Laboratory investigations £2.5 billion / year ( ie $3.6b ) • Approximately 4% of total NHS expenditure • Annual increase in workload 8-10% • 25% of pathology tests unnecessary

– Department of Health Independent Review of Pathology Services 2009

• BUT same amount of under requesting?

• Local audit July 2012 – Inpatients 34% “inappropriate”

Studies outside the UK 4.5 – 95% inappropriate lab use Van Walraven JAMA: 1998 (US) 5.1% Weydert Arch Pathol Lab Med: 2005: 129: 1141-1143 (US) 21% (No reason and low yield) Pal et al JMGIMS: 2009: 14: ii: 40-46

(India) 30% “Consensus” estimate AACC Webinar 26th Oct 2010 30% Repeat testing van Walraven Clin Chem 2003;49:12 (Canada)

Lab-related causes of diagnostic error

• Inappropriate test ordered • Appropriate test not ordered • Appropriate test result not used properly

– Knowledge deficit – wrong interpretation – Misleading result

• Appropriate test result delayed/missed • Appropriate test result wrong – RARE! (Epner & Astion, 2012) Wrong test choice accounts for up to 50 – 60% of

missed / delayed diagnoses ( Plebani, 2010)

Primary Care Physicians Challenges in Ordering Clinical Laboratory Tests and

Interpreting Results Physicians order tests in 31% of patient

encounters 14.7% report uncertainty about ordering 8.3% report uncertainty about interpreting Potentially affects 23 million patients pa Hickner et al JABFM 2014; 27: 268-274

“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

ConfidentUsually ConfidentNot Confident

Khromova and Gray (Ann Clin Biochem) 2008

Questions Oxford ,2010

Answer Options Correct Answer

% Correct

1. Which of the following blood groups would it be unsafe to transfer to a man of blood group O Rhesus positive?

O Rh positive

O Rh negative

A Rh positive

A Rh positive

77

2. In a patient on Warfarin in whom there is no, or only minor bleeding, at what INR would you consider administering Vitamin K?

3 5 7 8 10

8

36

3. The following test result would confirm a diagnosis of iron deficiency:

A low serum iron

Both a low serum iron and low transferrin

A low serum ferritin

A low serum ferritin

61

The Problems

• Too many tests

• Different names

• Different units

• Different reference intervals

• Different alert limits

• Inconsistent guidelines

Vitamin D Dickerson and Astion, CLN, Jan 2015

Aimed to Improve Test Utilization Manual to technology based interventions

At Seattle children’s hospital: 66% of 1,25-(OH)2 D ordered in error Intended test is 25 (OH) D ( T½ 3 wks vs 4-6 hrs )

⇨ SUCCESS

Manual : Email intervention/education for 12 months 53% of 1,25 (OH) 2 Vitamin D cancelled

Removed intervention for 2 months, requesting ⇧

Final intervention: 1,25(OH)2 Vitamin D only available to endocrinologists and nephrologists

CPOE Phase 1 & 2: ‘pop-up messages’

UK implementing an England-wide model for EHR presented with an initial pathology catalogue derived from a multiplicity of sources:

– Duplications – Inconsistent naming formats – Ambiguity. Unclear what the lab response to a request should

be – Not fit for purpose of applying national codes (SNOMED)

UK

Example: Vitamin Ds

D2 & D3 – closely defined molecular entities

“Total 25-hydroxy D” may be either: 1. A calculated sum of D2 & D3 (say by LC-MSMS). or 2. A measured level by immunoassay.

Strategies for Changing Physician Behaviour in Ordering Lab Tests

• Bandolier Review of 49 articles between 1966 and 1998

• Strategies that don’t work by themselves • Physician consensus building • Test guideline dissemination • Traditional education • Utilisation audits • Inform physicians of lab test charges

Published:

J Clin Path

BMJ

Box 1 Minimum Re-testing Interval Work Streams Renal Liver and Bone Endocrine Lipids and Diabetes Specific Proteins Cardiac Tumour Markers Gastro-Intestinal Occupational/Toxicology Therapeutic Drug Monitoring Pregnancy and Paediatrics

National Minimum Re-testing Interval Project 2013: A final report detailing consensus recommendations for

minimum re-testing intervals for use in Clinical Biochemistry

The Association for Clinical Biochemistry and Laboratory Medicine

To be published Summer 2015: National Minimum Re-testing Intervals: • Clinical Biochemistry [see previous] • Haematology – general, coag, transfusion • Immunology • Microbiology • Virology • Cellular Pathology

Proposed harmonised Profile( Panel) test content S Smellie BMJ: 2012: Mar 22 epub

Profile Potential content Proposed content

PoiPPotent

LiLFT Potential Proposed

Bilirubin Bilirubin

( Liver Panel) ALT ALT

AST ALP

ALP Albumin

γGT

LDH Questionable:

Albumin Total Protein and Calculated Globulins

UK: “ Do not Do” [NICE April 2014]

US: “Choosing Wisely” [NEJM 2014]

Atrius Health (2014) [ACO]

Guidelines for an annual physical

Displaying cost information

Liver function tests in patients on statins

Vitamin D - education

Incentive : Reimbursement paid in form of capitation, for 70% of patients

$1 Million

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

Gamma-GT

0

100

200

300

400

500

600

Apr-07 Oct-07 Apr-08 Oct-08 Apr-09 Oct-09 Apr-10 Oct-10 Apr-11 Oct-11

Date

Test

s pe

r mon

th

New electroninc order system introduced,with 'tick box' for Gamma-GT on front page

Request screens redesigned to eliminate 'tick box' and make testonly available by searching.

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.

L&D Audit of inpatient Magnesium and Phosphate requests Dec. 2014: Pre and post

guidance with consultant input

% Inappropriate Magnesium Phosphate

Pre (n=353) 52.3 48.7

Post (n=223) 37.0 29.0

Change in number of tests sent for urine toxicology screening (including drugs of abuse) per month after request vetting.

Saving $45,000 pa

Summary of intervention strategies to improve physician ordering behaviour

[DB Freedman eJIFCC 2015 26: 1, 15-30]

• Guidelines, education and audit of adherence, outcomes • Use of Formularies • Standardize nomenclature, units, profiles and ref intervals • Electronic order systems (CPOE) • Diagnostic algorithms, reflex and reflective testing • Minimum retesting intervals • Request vetting and restrictions • Feedback to users – activity data, appropriateness and

costs • Multiple interventions

– MUST stay in place otherwise behaviour will drift back to the unwanted condition

Zhi et al (2013)

• Overall mean rate of inappropriate overutilization = 20.6% (95% CI 16.2 – 24.9%, n=114)

• Overall mean rate of underutilization = 44.8% (95% CI 33.8-55.8%, n= 18)

IBD and IBS - UK Bloating / distension, abdominal pain, altered bowel

habit – common Clinical exam / history alone not always reliable –

DIAGNOSTIC DILEMMA Coeliac, somatisation, infective, gynae pathology. ? IBD

Patients per year

• Ulcerative Colitis 120,000 • Crohn’s 60,000 • IBS* 9 million

*UK population Approx 60 million IBS incidence 10-20% Average 15%

HOW WIDELY USED IS IT ?

CALPROTECTIN CLINICAL USE

• Distinguishes functional (IBS) symptoms from organic symptoms (inflammatory) - >95% sensitivity and specificity

• Normal result excludes IBD and requirement to scope

• Sigmoidoscopy tarriff = $790, Colonoscopy $1040 • Faecal calprotectin testing = $70

• Luton experience (patients referred where diagnosis

of organic versus functional disease uncertain): – In secondary care, – 70% reduction in Endoscopy – Potential saving $68,000 per 100 patients

Reflective “Add on” Tests Case: 65y/o F c/o tingling and cramps

Initially GP requested Bone profile Adjusted Calcium 7.2 mg/dL (9-11)

Subsequently GP requested PTH and Vitamin D PTH Low Vitamin D Normal

Discussion with GP – patient on Omeprazole (PPI) for 3yrs

Magnesium added Magnesium 0.60 mg/dL

(1.8-3.6)

Case: 65y/o F c/o tingling and cramps Hypomagnesaemia

Cardiac dysrhythmia, including ventricular fibrillation

Emergency Admission $2400 plus

Stay on CCU $1200/day

International Health Rankings (Commonwealth Fund, 2014)

AU CH CA DE FR NL NO NZ SE UK US

Overall rank 4 2 10 5 9 5 7 7 3 1 11 Safe care 3 4 10 6 2 7 11 8 5 1 7 $ Per capita 2011 3800 5643 4522 4495 4118 5099 5669 3182 3925 3405 8508

A final thought….

“We need to recognise that the target (of requesting the test and the results) should be the patient. It is the person who actually, in the end, is going to have to change their lives and start adopting new behaviours….”

adapted from Thomas Goetz, 2010 The Decision Tree: taking control of your health in the New Era of personalised medicine.

With grateful thanks to:

Dr David Housley, BSc(Hons), MSc, PhD, FRCPath Luton, UK Rebecca Leyland ,BSc(Hons), MSc,Dip RCPath Luton, UK