Texas Newborn Screening Performance Measures Project

(1)

Texas Newborn Screening

Performance Measures Project

Susan Tanksley, PhD

MSGRCC Annual Meeting

July 14, 2011

The Texas Newborn Screening Performance Measure Project (TNSPMP) is funded through a cooperative agreement with the Centers for Disease Control and Prevention (CDC). Agreement

(2)

2

Texas Newborn Screening Performance

Measures Project (TNSPMP)

 3 year CDC Cooperative Agreement

September 2007 – May 2011

 Overall project goal



Develop and identify evidence-based performance

measures to improve patient care for newborns

identified with disorders through the newborn

screening program

(3)

Infant Born Specimen Collected Specimen Transported Specimen Received Specimen Prepared Screening Performed Results Verified Follow up with patient Effect on Patient Care Action Taken P R E A N A L Y T I C A L P O S T A N A L Y T I C A L ANALYTICAL PATIENT CARE

Parent & Provider Education

Results Reported

Physician and Parent Notified of Abnormal

Result

(4)

TNSPMP Goals

 Goal 1 - Formalize a Steering Committee to

guide project

 Goal 2 - Develop and define performance

measures that may reveal gaps

 Goal 3 - Pilot key performance measures for

effectiveness

 Goal 4 - Identify, recommend, and document

evidence-based interventions

(5)

Project Goal 1

Project Goal 1 - Formalize a Steering Committee to

guide the project



Developed external stakeholder team representative of the

NBS System



Created DSHS Project Team from Laboratory and Follow-up

(6)

(7)

Project Goal 2

Project Goal 2 - Develop and define

performance measures that may reveal

gaps in the system.

 1) System assessment – where are we now?

 Conducted Internal Program Evaluation and Assessment Scheme

(PEAS) for Texas Newborn Screening Program

 2005 external review of the program by NNSGRC

 Stakeholder input - Brainstorming sessions at 1st two meetings

 Texas NBS Program Gaps and Barriers Summary Report (May

2008)

• Cross walk of findings between PEAS, NNSGRC Consultative Report, and stakeholder observations

(8)

(9)

9

Existing Performance Measures

 Investigated existing measures in the NBS community



Conducted a national survey to identify existing performance

measures used by state NBS programs



Collected report cards (quality reports) from states

Best Evidence Clinical Expertise Patient Focused Evidence-Based

(10)



2) Reviewed literature to identify „evidence-based‟

performance measures

 Time to treatment and its affect on patient outcome  Potential performance measures suggested by experts  Disorders

• CAH MSUD

• Galactosemia (GALT) PKU

• MCADD Sickle Cell Disease

• Congenital Hypothyroidism (CH)

 Difficult to find solid evidence



Identified approximately 50 performance measures



Hosted 9 Focus Groups with healthcare professionals

and consumers to assist with defining the measures and

developing standards

(11)

Universal Measure:

Time To Treatment

Time to initiate treatment

• Series of steps that can be measured discretely or as a group

• Help pinpoint where a breakdown has occurred

Pre-analytic Post-analytic

(12)

12 CAH

• Time to Initiate Treatment for SW CAH

• Time to Treatment for SW & SV CAH: By Gender • Time to Gender Assignment for SW CAH

• Frequency of Medical Evaluations that Assess Growth

MSUD

• Time to Initiate Treatment

• Time to Reduce Plasma Leucine Concentration Levels • Mean Annual Leucine Levels for Long Term Metabolic

Control PKU

• Time to Initiate Treatment

• Frequency of Phenylalanine Monitoring for Metabolic

Control

• Monitoring Average Phenylalanine Levels • Dietary Compliance

Galactosemia

• Time to Initiate Treatment • Dietary Compliance

MCADD

• Time to Confirmed Diagnosis

• Hospitalization for Severe Episodes related to MCADD • Parent Understanding Post Physician Notification • Adherence to Dietary Treatment (Avoid Fasting) • Screening/Diagnosis of At-Risk Family Members • Normal Developmental & Cognitive Outcome by Age 4

Sickle Cell

• Time to Initiate Penicillin Treatment (HbSS)

• Compliance with Oral Prophylactic Prescription of

Penicillin (HbSS)

• Age of First Prevnar® Vaccination (PCV-7) • Parent Education on Assessing Enlarged

Spleen/Monitoring Episodes of Fever (SCD)

• Clinical Evaluation at Age 5 for Disease Management • Genetic Counseling of Parents

Timeliness

• Turnaround Times (All not listed)

Specimen Collection Time Specimen Transit Turnaround

Days from Abnormal Screen Resulting until Physician

Notification

Days from Physician Notification until Parent Notification Days from Parent Notification until Physician Specialist Visit

for Confirmatory Testing

Days from Physician Specialist Visit until Receipt of

Confirmatory Testing Results, etc.

• Percent Missing Birth Weight • Percent Missing Date of Birth • Percent Missing Date of Collection • Percent Missing PCP Information

• Percent with Incorrect PCP Information • Unsatisfactory Specimen Rate

CH

• Time to Initiate Treatment • Initial Dosage of L-Thyroxine

• Normalization of Serum TSH, T4 and FT4 Concentration

within One Month of Treatment

• Evaluation for Transient/Permanent CH by Age 4

(13)

TNSPMP Task at Hand

Brainstormed Evidence-Based Actionable

Identification Process Selection Process Proposal Process

(14)

# Evaluation Criterion Scoring

1 The performance measure is scientifically sound 1 -10

2 The performance measure is relevant to the stakeholders in the newborn screening system

1 - 5

3 The performance measure can reveal health care disparities 1 - 5

4 The performance measure has great potential for improving

health care quality

1 -10

5 The performance measure has significant health importance 1 - 5

6 The performance measure can be used to improve the

newborn screening system

1 - 5

Impact Assessment

What overall impact will the measure have on health outcomes?

(15)

Feasibility Assessment

 Data elements

 Are the data elements identified and clear?

 Data collection methods

 Are there collection methods in place for all of the data

elements?

 Ease of data collection

 Will it be easy or difficult to collect and report the data?

• The ease of querying the data from the database

• The response rate for data requested via case management forms • The need to add a database field to capture data

• The need for a collection method • Data entry needs

Can the measure be implemented/maintained with existing staff and funding and can the data be collected for a 6 month pilot?

(16)

Selection of Performance Measures

 Impact

 What difference will the

measure have on patient outcomes?

 Online survey completed by

full team

 Feasibility

 What are the logistics required

to implement the measure during a 6 month pilot?

 Online survey completed by

DSHS staff

 Affinity Exercise

 August 2009 Stakeholders

“voted” on each performance measure. Quadrant I Strong candidate to pilot Quadrant II Qualified candidate to pilot in year three but may require infrastructure needs

Quadrant III Weak candidate Will not be considered to pilot Quadrant IV Weak candidate Will not be considered to pilot High Impact High Impact Low Impact Low Impact Low Low Feasibility Feasibility High High Feasibility Feasibility

(17)

Sample Performance Measures

 CAH

 Time to Correct Gender Assignment

 Time to Treatment for SW CAH

 Time to Treatment for SW & SV CAH; Female Vs Male

 Frequency of Developmental Evaluations thru Age 18

 CH

 Time to Treatment

 Appropriate Dosage of L-Thyroxine

 Number of Newborns with Normal Serum TSH, T4 and FT4

Concentration within One Month of Treatment

 Number of Newborns Receiving Assessment for Co-morbidities

 Number of Patients Receiving Evaluation for

(18)

Next Steps

 MCAD

 Time to Diagnosis

 Hospitalization Rate

 Parent Understanding Post Physician Notification

 Adherence to Dietary Treatment (Avoid Fasting)

 Screening/Diagnosis of Family Members

 Frequency of Developmental Evaluation thru Age 4

 Sickle Cell Diseases

 Time to Treatment of SCA or SCD

 Compliance of Prophylactic Prescription of Penicillin thru Age 5

 Age of First Prevnar® Vaccination (PCV-7)

 Number of Parents Educated on Assessing Enlarged

Spleen/Monitoring Episodes of Fever

 Number of Patients Receiving Detailed Assessment &

Parent Consultation at Age 5 Years

 Genetic Counseling for Parents

(19)

Congenital Adrenal Hyperplasia

• Time to initiate treatment for SW & SV CAH: By Gender

MSUD

• Time to Initiate Treatment

• Time to Reduce Plasma Leucine Concentration Levels

PKU

• Time to initiate treatment for infants with PKU • Monitoring phenylalanine levels in infants with

PKU for metabolic control Galactosemia

• Time to initiate treatment (Soy Based Diet) for infants with galactosemia

MCADD

• Time to treatment for infants with MCADD

Sickle Cell

• Time to Penicillin treatment for infants with sickle cell anemia

• Time of pneumococal vaccination for infants

Universal: Specimen Quality

• Percent NBS specimens missing date/time of collection, date/time of birth, birth weight, physician information

• Unsatisfactory NBS Specimen Rate Universal: Timeliness

• Time from birth to NBS specimen collection for the initial screen

• NBS specimen transit time from collection to receipt in the laboratory

• Time from laboratory out-of-range NBS result to notification of follow-up staff • Time from out-of-range NBS result until

physician notification

• Time from birth until physician notification of out-of-range NBS

Congenital Hypothyroidism

• Time to Initiate Treatment for primary CH • Initial Dosage of thyroid replacement therapy

for newborns with primary congenital

(20)

Definitions….

Time to Initiate Treatment for Primary Congenital Hypothyroidism

 Significance of Measure

 If untreated, congenital hypothyroidism (CH) can lead to mental retardation and poor physical growth. When thyroid hormone replacement treatment begins in the neonatal period, normal growth and development can be expected.

 Conceptual and Operational Definitions  Conceptual

 Measure the time it takes from birth to initial thyroid hormone replacement treatment for an infant with primary CH.

 Operational

 Numerator: For a specified reporting period and physician or pediatric subspecialist, the number of infants with primary CH receiving thyroid hormone replacement

treatment where the date of birth minus the date of treatment is 14 days or less.

 Denominator: The number of infants with primary CH documented by the Texas NBS Program within the specified reporting period per physician or pediatric subspecialist.  Performance Standard

 Disorder specific treatment initiated within 14 days of age.  Performance Goal

(21)

Project Goal 3

Project Goal 3 - Pilot key performance measures for

effectiveness in improving time to treatment for infants

with newborn screening disorders.

 Each of the final performance measures has been defined,

evaluated and data summary reports developed.

 Pre- and post-analytical report cards have been developed.

 Refined pre-analytical NBS report card format

 Provide a gold standard and state average for comparison

 Produced through automated process/to be available online

 Retrospective data analysis has been completed for July to

December 2009.

 July to December 2010 data being collected and analyzed for

comparison to retrospective data.

(22)

Specimen Transit Time from

Collection to Receipt in the Lab

56% 56% 57% 60% 60% _52% _52% 48% 48% 40% 44% 40% 43% 44% 0 10 20 30 40 50 60 70 80 90 100 TOTAL (N=406,629) July (n=71,991) August (n=68,536) September (n=70,197) October (n=68,364) November (n=60,724) December (n=66,817)

NBS Specimens Received by the State Public Health Laboratory

P e rc e n ta g e

Outside the performance standard Received within 3 days of collection

(23)

Percent NBS Specimen Missing DOB

99.84 99.82 99.80 99.88 99.81 99.84 99.88 0.16 0.18 0.20 0.12 0.19 0.16 0.12 95.00 96.00 97.00 98.00 99.00 100.00 TOTAL (N=406,629) July (n=71,991) August (n=68,536) September (n=70,197) October (n=68,364) November (n=60,724) December (n=66,817) NBS Specimens Received by the State Public Health Laboratory

Pe rc e n ta g e

(24)

Percent NBS Specimen Missing TOB

78 79 78 78 77 78 78 22 22 23 22 22 21 22 0 20 40 60 80 100 TOTAL (N=406,629) July (n=71,991) August (n=68,536) September (n=70,197) October (n=68,364) November (n=60,724) December (n=66,817)

P e rc e n ta g e

TOB available TOB missing/invalid

(25)

Percent NBS Specimen

Missing Birth Weight

94.97 95.37 94.90 94.95 94.78 94.76 95.01 4.99 5.24 5.22 5.05 5.10 4.63 5.03 50.00 60.00 70.00 80.00 90.00 100.00 TOTAL (N=406,629) July (n=71,991) August (n=68,536) September (n=70,197) October (n=68,364) November (n=60,724) December (n=66,817)

P e rc e n ta g e

(26)

(27)

TX NBS Report Card

New Format

Report Card: New Format

(28)

Time to Initiate Treatment for Salt Wasting Congenital

Adrenal Hyperplasia: by Gender

Disorder - specific treatment initiated within 7 days of age.

CAH Salt Waster - Time to Treatment

1 1 2 1 2 1 1 0 1 2 3 4

1 to 10 Days 11 to 20 Days 21 to 30 Days 31 to 40 Days 41 to 50 Days

Days N o . C a s e s

Females Males Unknown

Minimum 9 days to

treatment for these

9 cases.

(29)

Time to Initiate Treatment for Infants with

Phenylketonuria Disorder - specific treatment

initiated within 30 days of age

2 5 3 0 1 2 3 4 5 6

1 to 10 Days 11 to 20 Days 21 to 30 Days

N o . C ases Days

PKU - Time to Treatment

All 10 cases for

this time period

were treated

within 30 days

(30)

Time to Penicillin Treatment for Infants with

Sickle Cell Anemia - Twice-daily prophylactic

penicillin therapy initiated by 2 months of age

1 3 3 9 4 6 9 4 7 1 1 2 2 2 5 5 1 1 1 0 2 4 6 8 10 12 14 16 1 to 10 Days 11 to 20 Days 21 to 30 Days 31 to 40 Days 41 to 50 Days 51 to 60 Days 61 to 70 Days 71 to 80 Days 81 to 100 Days < 101 Days No. Cas e s Days

Hemoglobin - Time to Treatment

SS Sickle Cell Anemia SC Sickle C Disease S Beta Zero Thalassemia

•94 cases for this time period. •24 contained no treatment initiation date.

•28 cases were treated within 2 months of age

(31)

(32)

Project Goal 4

Project Goal 4 – Identify, recommend, and

document evidence-based interventions



Brainstorming sessions held with stakeholders to gather

intervention ideas and score feasibility of those ideas.



Explored evidence-based interventions through an

assessment of available literature and linked to the gaps

& barriers when possible.



Distributed survey to other US NBS Programs asking for

ideas on intervention strategies.



Interventions to be included in updated gaps/barriers

document.

(33)

Target Intervention Areas

Education Long-Term Follow-Up Provider Evaluation Information Systems Courier Programs Collaboration w/ Peers

(34)

34 DEVELOP TEST IMPLEMENT EVALUATE MODIFY REPLACE PLAN