sustainable healthcare: is quality pathology the key? · 2018. 10. 22. · sustainable healthcare:...

Sustainable Healthcare: Is Quality Pathology the Key?

Howard Morris PhD, FAACB, FFSc(RCPA)President IFCC

Professor of Laboratory MedicineUniversity of South Australia

Clinical Scientist, SA PathologyAdelaide, South Australia

Challenges for Healthcare Delivery

• Increasing patient expectations• Growing rates of chronic diseases• Ageing of the population• Increasing costs of medical advances• Limited growth of healthcare budgets

The example of Central Adelaide Local Health Network (CALHN)

• August 2018: $0.25B over budget out of a total budget $1.64B –administrators KordaMentha called in to provide recommendations

• History – 2004, identified that if rate of increase of SA Health budget continued then total SA budget would be consumed by health by 2025. Actions initiated – construction of new RAH hospital ($2.8B opened 2017), - major reorganization of public healthcare under ‘Transforming Health’ program

• Despite 10 years of work, overspending of allocated budgets continues (although I accept that stable figures are currently unavailable)


• Current strategy of KordaMentha review -Key areas of focus: •Workforce planning and Capacity Building •Clinical Service Planning and Delivery Models •Cultural Enhancement and Renewal

Jenny Richter, CEO CALHN


• Where do the diagnostic disciplines stand? SA Pathology, SA Imaging and SA Pharmacy exist outside the clinical areas in State-wide Clinical Support Services Current involvement will be to discuss how the price of the ‘services’ can be reduced – current expenditure $0.1B/y.Clearly SA Health has a major sustainability issue but does not consider diagnostic disciplines as part of the solution other than through reducing their budgets

Challenges for Healthcare Delivery

• These challenges suggest that rationing of healthcare delivery in some form will be introduced.

• Under such conditions all healthcare workers have a responsibility to work towards alternate methods for delivering sustainable healthcare

How does healthcare contribute to our community?

Sources: Australian Bureau Statistics 2014a; ABS 2014b (Table S1).

Australian Life expectancy, 1881–1890 to 2011–2013

Increases in life expectancy create wealth for governments, communities and individuals

Expenditure on improving life expectancy is an investment with large financial returns similar to the current Australian migration policy

Source: Australian Government : Australian Institute of Health and Welfare, 2000

Death Rates for Cardiovascular Disease in Australia(age-standardised rate per 100,000 persons)

Years

Male

Female

Rate per 100,000

Many factors have contributed to this reduction in the death rate from cardiovascular disease:

Improvements in: cardiovascular surgery and medicine nutrition with a reduction of saturated (animal) fats in our

diet and increases in mono-unsaturated or polyunsaturated fats (vegetable or fish oils) quality pathology with accurate serum cholesterol assays,

new biomarkers such as LDL-C

Modifiable factors to reduce the risk of CHD

Three most important modifiable factors to reduce the risk of CHD are:• Cigarette smoking• High blood pressure• High blood cholesterol levels

Conclusive data from randomised, controlled clinical trials demonstrated that lowering blood cholesterol reduces the risk of CHD and defined critical values for cholesterol

Accuracy of serum cholesterol measurements 1988 the USA’s National Cholesterol Education Program (NCEP) commenced a

strategy to reduce the prevalence of increased blood cholesterol and identified critical limits for blood cholesterol:

< 5.5 mmol/L Desirable5.5 to 6.4 mmol/L Borderline≥ 6.5 mmol/L High

Public health campaign: “know your number and do something about it”

Why do we need traceability of clinical laboratory lipid measurements?

This campaign generated unprecedented attention on the performance of clinical laboratories and the reliability of clinical testing

NCEP adopted performance goals for cholesterol testing:Coefficient of Variation (CV) < 3 %Bias + 3 %

This strategy required cholesterol testing in each clinical laboratory to be traceable to the an internationally recognized standard reference material

Hospitals and Clinical Laboratories(thousands)

How did we introduce standardized cholesterol assays to all clinical laboratories?

Slide courtesy of Dr David Bunk, NIST USA

CDC

International Network of Labs

NIST/CSTL


Certification and QC

SRM and SRP – ID GC-MS

A/K 2◦ Reference Procedure

Cholesterol Standard Reference Material and Reference Measurement Procedure Provides Traceability for Cholesterol Assays for Clinical Laboratories

Slide courtesy of Dr David Bunk, NIST USANIST, National Institute of Science and Technology, USACDC, Center for Disease Control, Atlanta, USA

CDC

International Network Labs

NIST/CSTL

Manufacturers



Certification and QCInstruments and Reagents

SRM and SRP – ID GC-MS


SRMsand other measurement

services

A/K 2◦ Reference Procedure

The Cholesterol Reference Measurement Procedure Provides Traceability for Cholesterol Assays for Clinical Laboratories

Slide courtesy of Dr David Bunk, NIST USANIST, National Institute of Science and Technology, USACDC, Center for Disease Control, Atlanta, USA

Impact: Lipid Standardization Program

190

200

210

220

230

Seru

m C

hole

ster

ol, m

g/dL

Women

Men

NHES1960-1962

NHANES I1971-1974

NHANES II1976-1980

NHANES III1988-1994

NHANES1999-2002

Adapted from Table 3, Carroll MD, Lacher DA, Sorlie PD, Cleeman JI, Gordon DJ, Wolz M, et al. JAMA 2005;294:1773-81

These studies were conducted in different labs using different methods at different times

Chart6

19611961

19721972

19781978

19911991

20012001

Women

Men

NHES1960-1962

NHANES I1971-1974

NHANES II1976-1980

NHANES III1988-1994

NHANES1999-2002

Men

Women

Serum Cholesterol, mg/dL

220

225

215

217

213

216

204

204

203

202

Sheet1

Data from JAMA 2005;294(14)1773-81

MenWomen

NHES19611960-1962220225

NHANES I19721971-1974215217

NHANES II19781976-1980213216

NHANES III19911988-1994204204

NHANES '99-'0220011999-2002203202

Sheet1

Women

Men

NHES1960-1962

NHANES I1971-1974

NHANES II1976-1980

NHANES III1988-1994

NHANES1999-2002

Men

Women

Serum Cholesterol, mg/dL

Sheet2

Sheet3

NIST Contributions toNational Reference

System for Cholesterol

Improvement of measurement between 1969 & 1998 may have saved $100M/year in US alone

for treatment costs

1967 - SRM 911Pure Cholesterol

1980 - Definitive Method forSerum Cholesterol

1981 - SRM 909 Cholesterol inHuman Serum

1988 - SRMs 1951 & 1952Cholesterol in Serum

1994 - Definitive Method for Serum Triglycerides

1996-7 - Values for HDL & LDL Cholesterol

1949 23.7%

1969 18.5%

1980 11.1%

1986 6.4%

1990 -1994 5.5 - 7.2%*

UnnecessaryTreatments

UntreatedDisease

Correct Value

FalsePositives

FalseNegatives

Wasted $$$Death

* Data fromGAO/PEMD-95-8

Improved Cholesterol Measurement Accuracy Saves Health Care DollarsCholesterol Measurements

Slide courtesy of Dr David Bunk, NIST USA

IMPACT OF LABORATORY PERFORMANCE ON OUTCOMES IN A SCREENING POPULATION FOR CARDIOVASCULAR DISEASE

• Subjects: 1,396 people (Age >=40 years) enrolled for CVD screening between January and April 2015 in Tainan, Taiwan.

• Individuals were classified into risk categories based on observed values for LDL-, HDL-, total cholesterol, and a 10-years CVD risk score.

• Patients with observed values of LDL≥ 4.9 mmol/L, 1.8

Incremental costs and QALY per strategy compared to the Control.

Microsimulation with 100,000 samples. Mean, 95%CI, Δ Costs per patient, Δ QALY per 1,000 subjects.

US$32

US$16

NT$Time-to-event microsimulation model structure

For every 1,000 subjects undergoing CVD screening, pathology analytical performance at MIN level resulted in a loss of life years of 131 and CVD related life-time costs of +US$280,096 per 1,000 subjects compared to CON

Current laboratory performance data indicate 99% of laboratories are better than MIN and 42% are at OPT level or better.

However before cholesterol assay standardization, most if not all laboratories were performing at worse than MIN level.Therefore current data confirm that cholesterol assay standardization translates into saving some $AU100 million per year in healthcare costs in Australia and 32,750 loss of life years

Summary:

Medical test results contribute to over 60% of clinical decisions

Evidence:• 79 cardiologists and oncologists were interviewed in USA and

Germany • Pathology results led to a significant clinical decision in 66% of

patients • Pathology accounted for just 2.3% and 1.4% of total health care

expenditure in the US and Germany respectively.

Rohr U-P, Binder C, Dieterle T, et al. The Value of In Vitro Diagnostic Testing in MedicalPractice: A Status Report. PLOS ONE | DOI:10.1371/journal.pone.0149856

Clinical laboratory investigations are at the centre of Healthcare delivery

Such a role entails significant responsibilities:

• Quality- Accurate and precise clinical data which are fit for clinical purposes

• Value - Efficient and cost-effective services which improve patient outcomes

Quality clinical laboratory services to meet clinical requirements

• Accurate laboratory results allow clinicians anywhere in the world to follow international practice guidelines on the basis of the same data from which they were derived to optimize patient outcomes

What is the Value of Healthcare?

• Current business models for the delivery of healthcare are executed in individual departments or silos

• These silos are assessed on the basis of activity.

• Each silo is managed according to their performance metrics

• Current value is defined as Activity per Cost.

What is the Value of Healthcare?Activity by itself does not necessarily create value

• The product of the healthcare system is the clinical care pathway for the patient

• Health is achieved when the patient successfully completes the clinical care pathway

• Value should now be defined as successful progression through the clinical care pathway

How can we demonstrate the Value of Pathology?

• Pathology operates on the fee-for-service (or cost-per-test) business model

• Current management largely focuses on the quality of analytical performance, volume of activity and cost of delivery

• Further pursuit of these strategies will not achieve the cost reductions required for sustainable healthcare

How can we demonstrate the Value of Pathology?

• The value of pathology is how the medical test result influences clinical decision making and changes the patient care pathway

Our Aim is to test the Usefulness of the Value Proposition for Pathology

• A value proposition is a statement that describes the benefits of a service, to whom it is delivered, and how the benefits can be achieved.

• The value proposition for laboratory medicine is expressed in terms of outcomes from guiding clinical decision making, the process of the care delivered and the resource required to deliver that care.

Price CP, St John A, Christenson R, et al. Leveraging the real value of laboratory medicine with the value proposition. Clin Chim Acta. 2016 Sep 17. pii: S0009-8981(16)30379-5. doi: 10.1016/j.cca.2016.09.006.

What are we aiming to deliver by adoption of the Value Proposition?

• Many healthcare disciplines are discussing the aspects of value. Such a calculation of value for all contributors to healthcare would provide a rational basis by which healthcare is resourced, organized and delivered.

• For pathology the key objective is to contribute to and facilitate decision making for the best health outcome for the individual patient, while minimising risk, and at reasonable cost.

• Adoption of a Value Proposition for pathology implies that the appropriate utilisation of medical testing can deliver clinical, operational and/or economic benefits spread across the whole patient care pathway, addressing the interests of all stakeholders.

High-sensitivity troponin testing: a case study

This publication presents 13 elements of the framework of a value proposition for laboratory medicine. Today I will only present 4 elements.

What is the unmet need?

• The timely delivery of troponin results in order to deliver the process for the safe rule out of Acute Coronary Syndrome or Myocardial Infarction in patients presenting to Emergency Departments with signs and symptoms of myocardial infarction and without ST elevation on an ECG examination (NSTEMI).

• The troponin value contributes to an accelerated diagnostic pathway (ADP) reducing waiting times in the Emergency Department (ED).

St John A, et al. Clin Chim Acta 2018; 477: 154-159

Who are the stakeholders?

• Patient• Emergency Department physician• Cardiologist• Hospital/ healthcare provider• Insurer/ payer• Clinical Chemistry department


What is the clinical pathway?• Patients with possible Acute Coronary Syndrome presenting to the Emergency

Department, who have had at least 5 minutes of possible cardiac symptoms occurring within the previous 12 h

• Blood samples taken at presentation (0 h) and at 2 h for measurement of hsTnI

• Perform ECG• Calculate the risk stratification score Thrombolysis in Myocardial Infarction

(TIMI)• Blood samples used for measurement of TnI using hsTnI assay with the 99th

percentile concentration of 26.2 ng/L, coefficient of variation < 5% and limit of detection 1.2 ng/L


Test intervention utility

• The utility of the hsTnI test is for the rule-out of ACS using blood samples collected at 0 and 2 h in conjunction with a risk prediction score (TIMI).

• ACS is ruled out if TIMI ≤ 1, the presentation ECG is non-ischaemic and the 0 and 2 hr hsTnI levels are below the cut-off, published as the modified ADAPT strategy (Cullen L, et al., J Am Coll Cardiol2013; 62: 1242-1249.)

What are the benefits?

• Primary outcome is the rapid and safe discharge of patients from ED who are at low risk of ACS (defined as low risk major cardiac adverse event within 30 days)

• Validation study reported “the potential to decrease admissions for approximately 40% of patients with suspected ACS” and compares with 17-20% with a conventional TnI assay (Cullen L, et al., J Am Coll Cardiol 2013; 62: 1242-1249.)

Cost-effectiveness matrix.

Paul Jülicher et al. BMJ Open 2017;7:e013653

©2017 by British Medical Journal Publishing Group

Strategy code: (1) standard, (2) hsTnI, (3) hsTnI+LoD, (4) hsTnI+ADP, (5) hsTnI+LoD+ADP, (6) hsTnI+LoD+ADP+direct rule-in. Costs include index costs and 30-day follow-up costs from the hospital perspective. Diagnostic accuracy refers to the adjudicated final diagnosis of acute coronary syndrome within 30 days after presentation to the emergency department. Each data point reflects the strategy specific mean value and 95% CI of 40 000 iterations. ADP, modified ADAPT accelerated diagnostic protocol; hsTnI, high-sensitivity troponin I; LoD, limit of detection.

Economic evidence

• High-sensitivity troponin I-supported algorithms increased diagnostic accuracy from 90.0% to 94.0% with an average cost reduction of $AU490 per patient compared with standard care.

• The inclusion of additional criteria for accelerated rule-out (limit of detection and the modified 2-hour ADAPT trial rules) avoided 7.5% of short-stay unit admissions or 25% of admissions to a cardiac ward.

• Protocols using high-sensitivity troponin I alone reduced length of stay by 6.2 hours and increased to 13.6 hours with high-sensitivity troponin I within accelerated diagnostic algorithms. Overnight stays decreased up to 43%.

• Results were seen for patients with non-acute coronary syndrome; no difference was found for patients with acute coronary syndrome.

Paul Jülicher et al. BMJ Open 2017;7:e013653

What are the benefits/disadvantages for stakeholders?

• Patient – less time reaching a diagnosis• ED physician – provides a means to reach specific targets and reduces times when ED is

crowded• Cardiologists – major contentious issue, perceived that hsTnI use will increase referrals.

Others argue that any elevated TnI probably indicates myocardial damage.• Hospital/healthcare provider – increase in early discharge of patients in whom an MI was

ruled out and may increase patient referrals to cardiologists.• Insurer/ payer – lower costs from faster time to diagnosis and discharge of patients• Clinical Chemistry Dept – Adoption of hsTnI assay requires provision of 1 h or less turn

around time and perhaps increased cost per test compared to conventional assay.

PERSONALIZED ANTIBIOTIC THERAPY FOR REDUCED INAPPROPRIATE EXPOSURE TO ANTIBIOTICS

https://www.diagnostics.abbott/int/en/univants-healthcare-excellence : Gluck E et al , Swedish Covenant Hospital, Chicago, IL

https://www.diagnostics.abbott/int/en/univants-healthcare-excellence

https://www.diagnostics.abbott/int/en/univants-healthcare-excellence : Gluck E et al , Swedish Covenant Hospital, Chicago, IL


Outcomes from Introduction of Procalcitonin testing in ICU setting

Summary• Reduced length of stay by 2.3

days• Reduced total hospital costs by

$2,759 per patient• Reduced antibiotic exposure by

23%https://www.diagnostics.abbott/int/en/univants-healthcare-excellence : Gluck E et al , Swedish Covenant Hospital, Chicago, IL


Improved Clinical Pathway for Recognizing and Treating Diabetes in Hospitalized Patients

https://www.diagnostics.abbott/int/en/univants-healthcare-excellence Fritz A et al., University Hospital Tübingen, Germany


7% of patients that present to the emergency department (ED) with formerly unrecognized diabetes can be identified, diagnosed and put into treatment programs

Survey findings* post-implementation of the care project at the University Hospital in Tübingen support the following: • 100% of clinicians indicated that knowing patient’s glycaemic status is important• 94% of clinicians surveyed felt knowing HbA1c value had a direct positive impact on treatment or triage of patients with the remaining 6% stating no impact. There were no responses stated that HbA1c had a negative impact.

“Long-term complications of diabetes involves substantial costs. Our diabetes care initiative helps to optimize treatment of patients with diabetes and prediabetes immediately upon presentation to the Emergency Department. While we are still collecting patient follow-up, we are confident that this program is associated with reduced costs, reduced complications, and reduced length of stay.”–Andreas Fritsche, MD, Diabetology, Professor Internal Medicine, University Hospital Tübing



Improving Visibility, Understanding and Value of Pathology

• As a profession and as individual practitioners pathology specialists need to educate the healthcare profession and the community

• Professional societies need to provide leadership by developing a compendium of tools for laboratorians to use in demonstrating the clinical laboratory’s value in the delivery of healthcare.

• IFCC and WASPaLM are collaborating on this project

Conclusions:• Pathology specialists must be capable of taking to the

negotiating table evidence-based proposals for sustainable healthcare within our own environments

• Quality analytical performance is the foundation for clinical laboratories providing testing fit for clinical purpose and improving cost-efficiencies

• Pathology specialists need to take leadership in research to generate evidence to leverage the value of pathology for sustainable healthcare

Sustainable Healthcare: �Is Quality Pathology the Key?Challenges for Healthcare DeliveryThe example of Central Adelaide Local Health Network (CALHN)The example of Central Adelaide Local Health Network (CALHN)The example of Central Adelaide Local Health Network (CALHN)Challenges for Healthcare DeliveryHow does healthcare contribute to our community?Slide Number 8Slide Number 9Many factors have contributed to this reduction in the death rate from cardiovascular disease:Modifiable factors to reduce the risk of CHDAccuracy of serum cholesterol measurements Why do we need traceability of clinical laboratory lipid measurements? Slide Number 14Slide Number 15Slide Number 16Impact: Lipid Standardization ProgramCholesterol MeasurementsSlide Number 19Slide Number 20Slide Number 21Slide Number 22Slide Number 23Quality clinical laboratory services to meet clinical requirementsWhat is the Value of Healthcare?What is the Value of Healthcare?How can we demonstrate the Value of Pathology?How can we demonstrate the Value of Pathology?Our Aim is to test the Usefulness of the Value Proposition for PathologyWhat are we aiming to deliver by adoption of the Value Proposition?High-sensitivity troponin testing: a case studyWhat is the unmet need?Who are the stakeholders?What is the clinical pathway?Test intervention utilityWhat are the benefits?Slide Number 37Economic evidenceWhat are the benefits/disadvantages for stakeholders?PERSONALIZED ANTIBIOTIC THERAPY FOR REDUCED INAPPROPRIATE EXPOSURE TO ANTIBIOTICS Slide Number 41Slide Number 42Slide Number 43Slide Number 44Slide Number 45Improving Visibility, Understanding and Value of PathologyConclusions:Slide Number 48

sustainable healthcare: is quality pathology the key? · 2018. 10. 22. · sustainable healthcare:...

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