Improving Data Quality and Quality Assurance in Newborn Screening by Including the Bloodspot Screening Collection Device Serial Number on

Birth Certificates

Brad Therrell, Ph.D., Director

National Newborn Screening and Genetics Resource Center

Austin, Texas

January 25, 2012

Brief Background Review A report on these issues was presented to the A report on these issues was presented to the

SACHDNC on January 22, 2010 on behalf of the SACHDNC on January 22, 2010 on behalf of the NBS Follow-up and Treatment Subcommittee.NBS Follow-up and Treatment Subcommittee.

Discussions included whether result information Discussions included whether result information should also be included on the birth certificateshould also be included on the birth certificate

Final recommendation was development of “a short Final recommendation was development of “a short white paper on the recommended changes to the white paper on the recommended changes to the birth certificate to ensure that all newborns are birth certificate to ensure that all newborns are screened at birth …”screened at birth …”

Subsequently the Executive Secretary of SACHDNC Subsequently the Executive Secretary of SACHDNC requested discussions with NAPHSIS and NCHS to requested discussions with NAPHSIS and NCHS to obtain their concurrence. obtain their concurrence.

Introduction NBS has been defined as a NBS has been defined as a corecore public health public health

program by the Association of State and Territorial program by the Association of State and Territorial Health Officials (ASTHO).Health Officials (ASTHO).

The Secretary of HHS has endorsed national The Secretary of HHS has endorsed national guidelines exist that define the recommended guidelines exist that define the recommended screening conditions. screening conditions.

All states have laws and/or rules that require both All states have laws and/or rules that require both newborn screening (NBS) and birth registration. newborn screening (NBS) and birth registration.

State health departments are generally responsible State health departments are generally responsible for implementing, overseeing and sustaining for implementing, overseeing and sustaining statewide NBS and for maintaining birth registration statewide NBS and for maintaining birth registration and other documentation of other vital events (e.g. and other documentation of other vital events (e.g. death). death).

Introduction Electronic record keeping for both activities exists in Electronic record keeping for both activities exists in

most states and where it does not exist, it is in final most states and where it does not exist, it is in final development. development.

Newborn Dried Bloodspot Screening (NDBS) serial Newborn Dried Bloodspot Screening (NDBS) serial numbers are used for inventory control and partial numbers are used for inventory control and partial patient tracking in all state NDBS programs. patient tracking in all state NDBS programs.

NDBS programs [and newborn hearing screening NDBS programs [and newborn hearing screening (NHS) programs] have a responsibility to monitor (NHS) programs] have a responsibility to monitor screening compliance as part of their quality screening compliance as part of their quality improvement efforts. improvement efforts.

Compliance requires validation against birth records.Compliance requires validation against birth records.

Challenges NDBS and/or NHS records do not always contain NDBS and/or NHS records do not always contain

the same name or other identifying information as the same name or other identifying information as that recorded in the birth registration record.that recorded in the birth registration record.

Birth registration regulations do not always require Birth registration regulations do not always require final completion in a manner that ensures timely final completion in a manner that ensures timely comparison with NBS test records.comparison with NBS test records.

NDBS and Newborn Hearing Screening (NHS) NDBS and Newborn Hearing Screening (NHS) programs are sometimes not co-managed and each programs are sometimes not co-managed and each may have a different tracking system.may have a different tracking system.

Management of birth registration programs and Management of birth registration programs and newborn screening programs are usually separated newborn screening programs are usually separated within the health department infrastructure and their within the health department infrastructure and their inter-relatedness may not be fully appreciated. inter-relatedness may not be fully appreciated.

Solutions? Manual matching – particularly those with smaller Manual matching – particularly those with smaller

birth cohorts.birth cohorts.

Electronic matchingElectronic matching

Deterministic matching – Relies on exact Deterministic matching – Relies on exact agreement between characters in specific data agreement between characters in specific data field(s) (eg. name, identification number, etc.). field(s) (eg. name, identification number, etc.).

Probabilistic matching - Uses statistical methods Probabilistic matching - Uses statistical methods to determine the frequency of data field matches to determine the frequency of data field matches and calculates a likelihood score (eg. first and and calculates a likelihood score (eg. first and last initial, date of birth, and sex) last initial, date of birth, and sex)

Solutions? Deterministic matching using the baby’s name is Deterministic matching using the baby’s name is

problematic because of errors in recording or problematic because of errors in recording or spelling, and because names may not be final by spelling, and because names may not be final by the time the specimen is submitted. the time the specimen is submitted.

Some states allow birth registration times that may Some states allow birth registration times that may be beyond the time most useful for optimal newborn be beyond the time most useful for optimal newborn screening validation.screening validation.

As a result, NBS programs tend to use probabilistic As a result, NBS programs tend to use probabilistic matching algorithms. The accuracy of matching matching algorithms. The accuracy of matching using such algorithms is directly related to the using such algorithms is directly related to the number of fields being matched, and resolution of number of fields being matched, and resolution of incomplete matches often requires excessive time incomplete matches often requires excessive time and labor.and labor.

Simplest Solution? Record initial NDBS serial number on birth Record initial NDBS serial number on birth

certificate and link the two databases.certificate and link the two databases. Linkage provides multiple payoffs:Linkage provides multiple payoffs:

NDBS programs can confirm that a specimen NDBS programs can confirm that a specimen was collected (or not) on all newborns.was collected (or not) on all newborns.

NHS programs could also have a link if the NDBS NHS programs could also have a link if the NDBS serial number were collected as part of the NHS serial number were collected as part of the NHS screen.screen.

Birth registration database is provided with an Birth registration database is provided with an external mechanism for electronically validating external mechanism for electronically validating patient demographic data.patient demographic data.

External Contributors CLSI Standard LA4-A5 - specifies a format suitable CLSI Standard LA4-A5 - specifies a format suitable

for NDBS serial numbers (includes optional for NDBS serial numbers (includes optional checksum character for quality check) checksum character for quality check)

NAPHSIS (organization for state birth registrars) - NAPHSIS (organization for state birth registrars) - creates a national forum to discuss and debate vital creates a national forum to discuss and debate vital records policy issues. records policy issues.

NCHS (CDC Center responsible for health NCHS (CDC Center responsible for health statistics) - maintains the statistics) - maintains the U.S. Standard Certificate U.S. Standard Certificate of Live Birth, of Live Birth, a suggested model for states to follow a suggested model for states to follow in collecting birth registration information. in collecting birth registration information.

HHS - National efforts to improve electronic health HHS - National efforts to improve electronic health record keeping.record keeping.

CLSI = Clinical Laboratory Standards Institute; NAPHSIS = National Association for Public Health Statistics and Information Systems; NCHS = National Center for Health Statistics; HHS = Department of Health and Human Services

Current Situation 96 % of states with electronic birth registration.96 % of states with electronic birth registration. 11 states with field in birth registration for NDBS 11 states with field in birth registration for NDBS

serial number (22%). 4 others (8%) with plans to serial number (22%). 4 others (8%) with plans to implement soon. implement soon.

4 states report that the serial number field is a 4 states report that the serial number field is a ‘required’ field in the birth registration process.‘required’ field in the birth registration process.

5 report using the field for linkage to assess 5 report using the field for linkage to assess compliance with NDBS requirement (others reported compliance with NDBS requirement (others reported plans to use it in this manner).plans to use it in this manner).

33 programs (66%) report some probabilistic linkage 33 programs (66%) report some probabilistic linkage between NDBS and birth certificates; 13 (26%) report between NDBS and birth certificates; 13 (26%) report no linkage; 4 (8%) did not respond. no linkage; 4 (8%) did not respond.

Matching time varied from hours to months.Matching time varied from hours to months.

Recommendations?

1. The SACHDNC should encourage State NDBS 1. The SACHDNC should encourage State NDBS programs to utilize a unique serial number on each programs to utilize a unique serial number on each initial newborn screening specimen collection initial newborn screening specimen collection device to aid in electronic tracking and identification. device to aid in electronic tracking and identification. To facilitate national harmonization, the format of To facilitate national harmonization, the format of this number should follow that recommended by the this number should follow that recommended by the national standard for collection of dried blood on national standard for collection of dried blood on filter paper, including strong consideration of a filter paper, including strong consideration of a checksum character as an aid in assuring the checksum character as an aid in assuring the quality of the computerized input of the serial quality of the computerized input of the serial number.number.

Recommendations?

2. The SACHDNC should work with NAPHSIS toward 2. The SACHDNC should work with NAPHSIS toward a goal of including the NDBS serial number on the a goal of including the NDBS serial number on the birth certificate to facilitate confirming access of all birth certificate to facilitate confirming access of all newborns to timely newborn screening and to newborns to timely newborn screening and to provide an external mechanism for evaluating provide an external mechanism for evaluating certain demographic data recorded on the birth certain demographic data recorded on the birth certificate. The use of these data for improving certificate. The use of these data for improving electronic health information and service quality electronic health information and service quality should be emphasized.should be emphasized.

Recommendations?

3. The SACHDNC should work with NCHS toward a 3. The SACHDNC should work with NCHS toward a goal of including a field for the NDBS serial number goal of including a field for the NDBS serial number (consistent with recommendations in CLSI LA4-A5) (consistent with recommendations in CLSI LA4-A5) in the next revision of the U.S. Standard Certificate in the next revision of the U.S. Standard Certificate of Live Birth to be recommended to the Secretary of of Live Birth to be recommended to the Secretary of Health and Human Services. Inclusion of this field Health and Human Services. Inclusion of this field should be ‘required’ inasmuch as NDBS is a should be ‘required’ inasmuch as NDBS is a required activity in all states and comparison of birth required activity in all states and comparison of birth certificates to NDBS specimen records represents certificates to NDBS specimen records represents the most efficient way to confirm screening the most efficient way to confirm screening universality.universality.

Recommendations?

4. State birth registrars and state newborn screening 4. State birth registrars and state newborn screening program directors should be encouraged to program directors should be encouraged to consider ways in which electronic data validation of consider ways in which electronic data validation of the demographic information collected by the two the demographic information collected by the two activities can be used for cross validation and data activities can be used for cross validation and data quality improvement.quality improvement.