Newborn Screening Lab Survey

Attachment G--Newborn Screening LABORATORY data collection

Form Approved 
OMB No. 0920­0879 
Expiration Date: 03/31/2014 

The Centers for Disease Control and Prevention’s Newborn Screening and Molecular Biology Branch (CDC NSMBB) is 
seeking your input to assess the needs of state newborn screening laboratories and inform current and future CDC 
NSMBB activities. CDC NSMBB houses the Newborn Screening Quality Assurance Program (NSQAP) and the recently 
created Molecular Assessment Program (MAP). 

*1. Which state(s) and/or region(s) does your newborn screening laboratory serve? In the

box below, please type all regions covered by your newborn screening laboratory.
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*2. Please tell us how much you agree or disagree with each statement about CDC

NSMBB activities.

Strongly 
Agree
a. CDC NSMBB is a trusted resource for state newborn screening 

Agree

Neutral

Disagree

Strongly 
Disagree

Don't 
Know/Not 
Applicable

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laboratories.
b. CDC NSMBB's Newborn Screening Quality Assurance Program 
materials help state newborn screening laboratories address CLIA and 
other regulatory requirements.
c. Access to CDC NSMBB's technical expertise promotes quality within 
state newborn screening laboratories.
d. Access to CDC NSMBB's educational and training opportunities 
promote quality within state newborn screening laboratories.
e. Access to CDC NSMBB's Molecular Assessment Program promotes 
quality within state newborn screening laboratories.
Please provide any additional information that should be considered when assessing CDC NSMBB's impact on state newborn screening 
laboratories. 

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Public reporting burden of this collection of information is estimated to average 20 minutes per response, including the time for reviewing 
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of 
information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a 
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including 
suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D­74, Atlanta, Georgia 
30333; ATTN: PRA (0920­0879). 

Attachment G--Newborn Screening LABORATORY data collection

*3. Please tell us how much you agree or disagree with each statement about potential

CDC NSMBB efforts.

Strongly 
Agree
a. CDC NSMBB should support pilot studies to harmonize newborn 

Agree

Neutral

Disagree

Strongly 
Disagree

Don't 
Know/Not 
Applicable

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screening results across testing platforms.
b. CDC NSMBB should support pilot studies to promote implementation 
of new newborn screening tests within state newborn screening 
laboratories.
c. CDC NSMBB should enhance web­based educational opportunities, 
such as technology­driven and issue­based webinars, for state newborn 
screening laboratories
Please provide any additional information about activities CDC NSMBB should consider to better support state newborn screening laboratories. 

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Attachment G--Newborn Screening LABORATORY data collection
Measurement of succinylacetone (SUAC) in newborn screening laboratories.

The following questions relate to measurement of SUAC in your newborn screening laboratory.  

*4. Does your laboratory measure succinylacetone (SUAC) in dried blood spots?

j Yes
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j No
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Attachment G--Newborn Screening LABORATORY data collection
Measurement of succinylacetone (SUAC) in newborn screening laboratories.

*5. Here are some items related to SUAC for labs currently measuring

it.

Yes

No

N/A

a. Do you report isolated elevations of tyrosine levels?

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b. Do you have cut offs for tyrosine based on birth weight?

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c. Do you have cut offs for tyrosine based on gestational age?

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d. Do you report elevated SUAC levels?

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e. Do you perform SUAC analysis only in response to an elevated 

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tyrosine? (i.e. SUAC analysis is only performed as a second­tier test)
f. Do you use SUAC and tyrosine as markers to identify infants with 
Tyrosinemia Type 1?
g. Were budgetary restrictions an obstacle to SUAC implementation in 
your laboratory?
h. Were technical resources and personnel issues considered obstacles 
to SUAC implementation in your laboratory? (e.g. were additional 
staff or instruments required for testing)
i. What were the major challenges to implementing SUAC testing in your laboratory? How were they overcome? 

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Attachment G--Newborn Screening LABORATORY data collection
Measurement of succinylacetone (SUAC) in newborn screening laboratories.

*6. Here are some items related to SUAC for labs not currently measuring it.
Yes

No

N/A

a. Do you report isolated elevations of tyrosine levels only?

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b. Do you have cut offs for tyrosine based on gestational age?

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c. Do you have cut offs for tyrosine based on birth weight?

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d. Is your laboratory considering the adoption of SUAC testing?

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e. Does your laboratory have, or is it requesting, the necessary funding, infrastructure, staff, and 

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f. Are budgetary restrictions an obstacle to SUAC implementation in your laboratory?

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g. Are insufficient technical resources and personnel an obstacle to SUAC implementation in your 

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technical expertise to pilot SUAC testing?

laboratory? (e.g. were additional staff or instruments are required for testing)
h. Is the current use of an assay that does not measure SUAC an obstacle to implementing SUAC 
testing in your laboratory?
i. Would a formal recommendation to use SUAC as the primary marker for Tyrosinemia Type 1, 
issued by the Secretary’s Advisory Committee on Heritable Disorders on Newborns and Children 
(SACHDNC), increase the likelihood of SUAC testing by your laboratory?
j. Would a formal recommendation to use SUAC as the primary marker for Tyrosinemia Type 1, 
issued by the Secretary of the Department of Health and Human Services, increase the likelihood of 
SUAC testing by your laboratory?
k. What do you consider to be your laboratory’s largest challenges to implementing SUAC testing? (e.g. why would it be difficult to integrate 
SUAC testing into the current workflow of your NBS laboratory?) 

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Attachment G--Newborn Screening LABORATORY data collection
Thank you for your responses. Press DONE to submit the survey.