National Survey of Pre- and Post- Analytical Performance Measures Used in Newborn Screening Programs
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1 National Survey of Pre- and Post- Analytical Performance Measures Used in Newborn Screening Programs Simran Tiwana, MBA* Susan Tanksley, PhD* Brad Therrell, PhD Donna Williams, BS* Mirsa Douglass, MBA* Colleen Buechner, MS *= Texas Department of State Health Services = National Newborn Screening and Genetic Resource Center
2 Introduction Performance Measures: Objective way to measure the degree of success of a program in terms of its goals and objectives Number of clients served Change in attitude Change in knowledge etc. Performance Measures in Newborn Screening: Unsatisfactory rate Number of serious complications avoided Number of deaths avoided etc.
3 The Texas Newborn Screening Performance Measures Project Three year grant funded by the Centers for Disease Control (CDC) Primary objective to develop evidence-based pre- and post-analytical performance measures to improve the newborn screening system Inputs sought via this survey to help in development of performance measures
4 Survey Objectives To gather information on: Existing pre-analytical performance measures Existing post-analytical performance measures Agencies/organizations to whom performance measures are reported Frequency of reporting to external agencies/organizations Suggestions for future performance measures to improve the NBS system
5 Methods Web-based survey sent to all 50 States and District of Columbia Follow-up via telephone
6 Survey Questions Survey questions allowed structured as well as unstructured (qualitative) responses Example: Within your newborn screening program, which preanalytical performance measures are routinely recorded? The following list includes some common examples please be sure to list any additional measures related to pre-analytical phases of newborn screening. (Choose all options that apply) 1. Number of specimens classified as unsatisfactory because of poor specimen quality 2. Number of specimens classified as unsatisfactory because of insufficient or inaccurate data 3. Time from collection to receipt in the laboratory 4. Other (Please Specify)
7 Survey Responses States that Responded Alaska and Hawaii responded as well!
8 Results Number of surveys sent out = 51 Number completed = 35 Response rate = 68.62% Average time taken to complete survey = 11 minutes
9 Pre-analytical Performance Measures Recorded by State Laboratories (total 103 responses from 35 states) Not applicable = 0 Others = 10 Unsat due to poor specimen quality = 35 Time from collection to receipt in lab = 32 Unsat due to insufficient data = 26
10 Other Pre-analytical Measures Collected by States Measures related to time Time from birth until specimen collection Time from collection until receipt in the lab Turn-around time within the lab Time from birth until newborn screen result Measures related to errors in data Errors in demographic data entry Specimens drawn before 24 hours or after 7 days Measures related to missing data Missed screens Refused screens
11 Post-analytical Performance Measures Recorded by State Laboratories (88 responses from 35 states) Time from Not applicable = 1 Time from abnormal screen result until treatment initiation = 25 Others = 14 abnormal screen result until physician contact = 24 Time from abnormal screen result until physician confirms diagnosis = 24
12 Other Post-analytical Measures Collected by States Time-related Date of physician visit Date of first repeat screen Birth-defects registration date Date of treatment initiation Data on abnormal results Percent abnormal results followed Annual list of confirmed cases detected via screening
13 Reporting of Performance Measures (58 responses from 35 states) Not Applicable = 1 External stakeholders = 29 Internal reviewers/ executives = 28
14 Reporting of Performance Measures: Types of External Agencies (97 responses from 35 states) Others = 11 Not applicable = 3 National Database = 21 State Legislature = 6 Contracting agency =10 Advisory committee = 21 Healthcare provider/ birthing facility = 25
15 Other External Stakeholders Notified by State Programs Medical sub-specialists State Board of Health Newborn screening workgroups Annual report for distribution and on the newborn screening program website
16 Frequency of Reporting to External Agencies (56 responses from 35 states) Others = 8 Monthly = 15 Not applicable = 3 Annually =12 Quarterly =14 Bi-annually = 4
17 Performance Measures Suggested for Future Time-related Time from abnormal screen result to physician notification Time from receipt in lab until final result is obtained Transit time Specimen collection time Time from birth until receipt of screening report by medical home
18 Performance Measures Suggested for Future Disorder-specific Measures Number (%) of infants diagnosed with Sickle Cell Disease and treated before 2 months of age Number (%) of infants diagnosed with PKU and treated before 7 days of age Number (%) of patients with PKU where Phenylalanine levels were maintained in an acceptable range >80% of the time Specimen collected too soon for testing based on condition (e.g. PKU, MSUD, CH, CAH etc.)
19 Performance Measures Suggested for Future Measures related to specimen quality Unsatisfactory specimen rates Specimen card field completion rate Inadequate specimen rate Hospitals to be informed about number of unsatisfactory specimens etc.
20 Performance Measures Suggested for Future Measures related to demographic information/birth records Number (%) of births matched with screening records Number (%) of births with documented screening completed Demographic data errors
21 Performance Measures Suggested for Future Measures related to feedback Long-term follow-up for patient outcomes False negative rate False positive rate False positive rate with second tier testing Periodic distribution of educational materials to families Number (%) of diagnosed cases reported to national system as they are received (without waiting until a specific time) Number (%) lost to follow-up Number (%) no diagnosis for greater than one year
22 Conclusions Pre- and post-analytical measures collected by all states Disparity in: Types of measures collected Reporting agency Frequency of reporting Not many measures currently being collected on longterm outcomes Measures suggested for the future by some states are already being collected by other states Some suggestions for improvement could apply to all states Need for standardization and uniformity Suggested measures match with suggestions made by the TNSPMP stakeholders, validate those suggestions
23 Questions?
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