Overview of the Public-Private Partnership Concept and ... · Requirements of a Successful P3 •...

Overview of the Public-Private Partnership Concept

and Cost/Benefit AdvantagesPiero Rinaldo, MD, PhDProfessor of Laboratory Medicine

T. Denny Sanford Professor of PediatricsMayo Clinic College of Medicine, Rochester, MN

Association of Public Health Laboratories (APHL)2007 Annual Meeting & First State Environmental Laboratory Conference

Jacksonville (FL), June 5, 2007

Outline• Past and current status of NBS in the US

• What is a public-private partnership?

• The MN model of newborn screening

• Cost/benefits and value-added

• What is next?

35%65%

% ofUS births

0%0%100%

Status of NBS in the US

83%

% ofUS births

2%2%98%

20072007Status of NBS in the US

The HRSA/ACMG Uniform Panel

Uniform Screening Panel (2006)• 29 primary conditions

– 20 detected by MS/MS (AA, FAO, OA)

– 3 Hb-pathies (S/S, S/βThal, S/C)

– 6 others (BIOT, CAH, CF, CH, GALT, HEAR)

• 25 secondary targets

– 22 detected by MS/MS (AA, FAO, OA)

– 1 Hb-pathy (many variants counted as one)

– 2 others (GAL-epimerase, GAL-kinase)

42/54 (78%) by MS/MS42/54 (78%) by MS/MS

The Arrival of MS/MSThe Arrival of MS/MS

Delivery of NBS Testingin the US (2007)

• Single state public health lab (± MS/MS)

• Public health “hub” for other state(s)

– Regional (geographical proximity)

– Non-regional

• Outsourcing to a private laboratory

• Public-private partnership





• What is next?

Public-Private Partnership (P3)"Public-private partnership" means any partnership between federal agencies, state agencies or individuals or any combination of federal agencies, state agencies or individuals, including corporations and private persons or organizations, where at least 1/3 of the funding is contributed by a non-governmental organization or individual.[2003, c. 414, Pt. A, §2 (new); c. 614, §9 (aff).]janus.state.me.us/legis/statutes/12/title12sec10301.html

Focus on Public Healthwww.unfoundation.org/files/pdf/2003/Public_Private_Part_Bro.pdf

Public-private partnerships involving governments, the private sector and civil society are increasingly recognized as an international solution for social issues of almost every type:• Building health care• Clean water systems• Sustaining the environment• Bridging the digital divide

Requirements of a Successful P3

• Examine the potential: Partnerships are time-consuming and often difficult. A P3 should deliver better results than what any partner could achieve alone

• Focus on the concrete: specific, shared activities leading to tangible outcomes are much better than simply a common vision or shared aims

• Agree to a shared governance structure: the best arrangements will adequately reflect underlying power relations

• Plan the details: a comprehensive strategy for building, maintaining and completing the partnership is vital, as is setting performance and management goals 11www.unfoundation.org/files/pdf/2003/Public_Private_Part_Bro.pdf


• Remain flexible: successful partnerships often evolve considerably during their lifespan, including in terms of membership. Plan explicit exit requirements

• Identify catalytic leadership: this can be particularly important at the early stages, to get the partnership off the ground; once operational, partnerships should be institutionalized, as senior leadership moves on to other opportunities

• Establish an appropriate time frame: partnerships usually take longer than expected to deliver results

22www.unfoundation.org/files/pdf/2003/Public_Private_Part_Bro.pdf


• Trust, but verify: trust is an essential part of public-private partnerships, particularly those attempting to span cultural differences. Trust is a necessary precondition, but it can also be reinforced through the process of partnering. Third party audits are useful

• Acknowledge that the job is difficult: partnerships are a challenge for most institutions. Even when all parties are committed and enthusiastic, successful P3 take significant resources to initiate and manage

• Write it down: a written agreement formalizes the partnership. At the outset, however, all parties should agree whether the purpose of the agreement is to define the partnership or the governance of the partnership

33www.unfoundation.org/files/pdf/2003/Public_Private_Part_Bro.pdf

• Better than individual components alone• Tangible outcomes• Shared governance structure• Performance goals• Exit strategy• Leadership succession• Time frame of deliverables• Trust, with adequate verification• Acknowledge that the job is difficult• Written agreement


www.unfoundation.org/files/pdf/2003/Public_Private_Part_Bro.pdf

Is the NBS program

in MN a P3?

Are we fulfillingthese requirements?

Are we successful?

YES

YES

YES

YES?

“Defining your criteria forsuccess is easier when you suck.

As you get better, it becomes harder. The steps are smaller.”

Bode MillerNewsweek, January 23, 2006 (p. 44)

“Defining your criteria forsuccess is easier when you suck.

As you get better, it becomes harder. The steps are smaller.”

Bode MillerNewsweek, January 23, 2006 (p. 44)





• What is next?

The Minnesota Model

A public-private partnership between

The Minnesota Department of Health (MDH)

The University of Minnesota

Mayo Clinic (Mayo Medical Laboratories)

What is the Minnesota Model?A public-private newborn screening

program based on COOPERATIONand COMMUNICATION between all parties involved with the goal toexpand and enhance the delivery of

•Laboratory tests

•Patient care

•Family services

Delivery of Laboratory Tests by the Newborn Screening Program in MN

S,FUS,FUS,FUS,FUFU

S,FUS,FU

-C-

2TS,C,2T

C-

Established Conditions Cong. HypothyroidismGalactosemia (GALT)

Sickle Cell Anemia21-Hydroxylase Def (CAH)

MS/MS (AA, OA, FAO)Biotinidase

Cystic Fibrosis

S ScreeningC Confirmatory

FU Follow up2T 2nd tier test in DBS

Delivery of Patient Care by the Newborn Screening Program in MN

• Notification of abnormal results

• Confirmatory testing (verification)

• Reporting and rapid disposition

• Clinical referral of true positives

• Short-/long-term follow up by specialist(s)

MN partnership=

Active cooperation&

constant communication

Screening Laboratory

BiochemicalGenetics

Laboratories

Primary Care

Provider

Metabolic Clinics

Notification• Phone• Fax• E-mail (website)

Please Visit SNS

E-mail Message (NO PHI)

Posting on Secure Website

• Commercial product (QuickPlace, IBM)• Provided by Mayo, at no cost to partners• Content sorted by topic (abnormals, unsat, etc..)• Messages “stringed” together in order of posting• Searchable by name, ID, keyword

• Commercial product (QuickPlace, IBM)• Provided by Mayo, at no cost to partners• Content sorted by topic (abnormals, unsat, etc..)• Messages “stringed” together in order of posting• Searchable by name, ID, keyword

MN P3: Expand and Enhance the Delivery of Patient Care

Verificationof Abnormal

Results


BiochemicalGenetics

Laboratories

Primary Care

Provider

Metabolic Clinics

Discouragerepeat submission

and testingof blood spots1

Activaterapid

confirmatorytesting

3

Prevent "blind"referrals to specialists

of false positives

2

Reportingof Diagnostic

Testing


BiochemicalGenetics

Laboratories

Primary Care

Provider

Metabolic ClinicsE-mail

notification

E-mailnotification

Referralof TRUEPositives

Confirmatorytesting is

already DONE


BiochemicalGenetics

Laboratories

Primary Care

Provider

Metabolic Clinics


BiochemicalGenetics

Laboratories

Primary Care

Provider

Metabolic Clinics

SHORT TermFollow-Up

BENEFITSAccurate statisticsLearning from experienceEducationCOST REDUCTION

E-mailnotification

Highlights of MN Model• Secure website for timely communication

– Every provider is on the same page• NO repeat blood spots

– Unless <24hr

States reported they spent over $120 millionon laboratory and program administration/ follow-up activities in state fiscal year 2001. Individual states’ expenditures ranged from $87,000 to about $27 million

GAO-03-449 State Newborn Screening Programs, March 2003

Routine Second SpecimenPEDIATRICS 117:S212-S252, 2006

~700,000 US newborns/yr are tested TWICEWhere is the evidence?

Is the Routine Collection of a Second Specimen Cost Effective?

MNMN

Why states with a two-specimensystem have a detection rateby MS/MS worse than ours?

Why states with a two-specimensystem have a detection rateby MS/MS worse than ours?

Highlights of MN Model• Secure website for timely communication

– Every provider is on the same page• NO routine second repeat blood spots

– Unless <24hr• Rapid confirmatory testing

– Completed in <48hr in most cases• NO clinical evaluation by metabolic

specialists of false positive cases• <1,800 g protocol (targeted repeats)• Second tier tests

2nd Tier Tests• A cost effective mean to implement clinically defined

cutoffs when normal population and disease range overlap (poor specificity)

• Performed in 1-2 batches weekly (except CAH)• Same specimen, no additional patient contact• Normal result overrules primary screening• Reporting of primary screening is not delayed

0.64% 0.06%

Why only 6 states?




• Cost/benefits ratio and value-added

• What is next?

Exactly, what is the“cost/benefits ratio”? Exactly, what is the“cost/benefits ratio”?

= VALUE= VALUE

Definition of ValueDefinition of Value

Value =Quality

CostHow do we improvethe value of NBS?

How do we improvethe value of NBS?

The Cost Reduction Model

Value =Quality

Cost

Avenues of Cost Reduction (Avoidance of Unnecessary Costs)

• Recall and repeat analysis (2nd, 3rd, 4th…)

• Disruption of care (premature, sick newborns)

• Outpatient, ER visit(s)

• Confirmatory testing

• Referral to metabolic specialist

• Disruption of family life (stress)

Reductionof false

positives

Reductionof false

positives

The Quality Improvement Model

Value =Quality

CostQuality = PerformanceQuality = Performance

Period

Volume *

Detection rate

False Pos. Rate

Pos. Pred. Value

Jul 04 - May 07

275,845

1:1,662

0.09%

41%

Performance Metrics in MNsince the Beginning of P3 (MS/MS)

Target

<1:3,000

<0.30%

>20%* Includes 58,643 from out of state

Trend of Performance Metrics in MNsince the Beginning of P3 (MS/MS)

P3

Pediatrics 2006; 118:448Pediatrics 2006; 118:448

MN

MN 2005 FP cases (MS/MS)

Predicted scenarios FPRBest case 81 0.11%Intermediate 808 1.14%Worst case 1606 2.27%

ACTUAL 52 0.07%


Better than individual components

Tangible outcomes

Shared governance structure

Performance goals

Exit strategy

Leadership succession

Timeframe of deliverables

Trust, with adequate verification

Acknowledge that the job is difficult

Written agreement

Yes!

NBS expansion

Adv Committee

Metrics (exceeded)

5 yr, renewable

MDH, UoM, Mayo

On time (ahead)

Sight visits

Can do attitude

Yes

Canthis modelbe appliedelsewhere?

HRSA Regional Collaborative ProjectLaboratory Quality Improvementof Newborn Screening by MS/MS

MS/MS working group, May 6, 2007

MarziaPasquali

StephanieMayfield

Value-added by Mayoto NBS (MN and beyond)

• Familiarity with the diagnosis of IEM

• High-throughput MS/MS environment

• Rapid (and complete) confirmatory testing

• Focus on performance metrics and quality: Leadership of collaborative project (72 labs worldwide)

• Development, validation, and implementation of 2nd tier tests (training freely available to all)

• Second opinion of questionable MS/MS results

• R&D toward future expansions





• What is next?Nature Reviews/Genetics, 2005Nature Reviews/Genetics, 2005

Nomination Form for New Conditions to be Added to Uniform Panel was

posted on HRSA website on May 18, 2007

Nomination Form for New Conditions to be Added to Uniform Panel was

posted on HRSA website on May 18, 2007

Candidate Conditionsfor Expansion of Uniform Panel

• ALD

• CDG Ib

• CMV

• DMD

• G6PD

• FHC

• Fragile X

• HIV

• LSD (multiplex)

• SCID

• SLO

• SMA

• Toxoplasmosis

• Wilson

WHO is going

to do all this?

SpeedyScreening

Active Research at Mayoon Candidate Conditions

• ALD

• CDG Ib

• CMV

• DMD

• G6PD

• FHC

• Fragile X

• HIV

• LSD (multiplex)

• SCID

• SLO

• SMA

• Toxoplasmosis

• Wilson

Conclusions• A public-private partnership is a viable

option for the Minnesota NBS program

• Cost-benefit advantages are accrued as a combination of shared resources, frequent communication, R&D, and improved analytical/post-analytical performance

• The applicability of this model to NBS is likely to grow as the breath and complexity of testing will increase

Of all cooperative enterprises, public health is the most important and gives the greatest return

Of all cooperative enterprises, public health is the most important and gives the greatest return

WHY Do We Do This?WHY Do We Do This?

Charles J. Mayo, MDCharles J. Mayo, MD

Overview of the Public-Private Partnership Concept and ... · Requirements of a Successful P3 •...

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