2B FollowupSurvey_REVISED_TrackedChanges 0014

OMB Number (0906-0014)
Expiration Date (09XX/30XX/2018XXXX)

FOLLOW-UP Survey of the Secretary’s Advisory Committee on Heritable
Disorders in Newborns and Children’s Public Health System Assessment
Public Burden Statement: 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. The OMB control number for this project is 0906-0014. Public reporting burden for
this collection of information is estimated to average XX 2 hours per response, including the
time for reviewing instructions, searching existing data sources, and completing and reviewing
the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to HRSA
Reports Clearance Officer, 5600 Fishers Lane, Room 10C-03I14N136B, Rockville, Maryland,

IMPLEMENTATION PROCESS
1. Describe the status of screening for [condition x] in your state. The first few questions deal
with the implementation process and some of the decisions your program had to make. In
what capacity are you screening for Condition X? How long have you been screening?
Probe 1: If you have initiated screening for [condition x], how long have you been
screening?
Probe 2: If you are in the process of adding [condition x] to your state panel, describe
where you are in the process.
Probe 3: If you are currently conducting evaluation activities or a pilot study, please
describe the nature and timeline of activities. Would the screening procedure be the same
if/when you add the condition as part of the state newborn screening panel? If not, what
screening procedures would you use for live newborn screening?
Probe 4: If you have not initiated screening for [condition x], do you plan to?
Probe 5: If you plan to implement screening for [condition x], when will you start the
process for adding condition x?

2. (States with mandate) If you have not started screening, when do you plan to start?

3. (States that are in the pilot stage) How long do you anticipate to be in a pilot phase? Was this
planned? Please explain.

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OMB Number (0906-0014)
Expiration Date (09XX/30XX/2018XXXX)

4.2. Please tell usdescribe how you implemented/plan to implement screening for
[cCondition x]X.

5.3. (For Sstates that have started screening) After having gone through theis
implementation process, was there something you would have changed?

6.4. (For sStates that have started screening) Did you have any surprises with
implementation? Please explain.

7.5. What has been/will be the most significant barrier challenge(s) with implementingto
screening for cCondition X?

8.6. Is there something specific to your program that has/will aid facilitatein implementation
of ing screening for [cCondition x]X?
METHODOLOGYLABORATORY
7. What Describe the methods you are you using to screen for [condition x] (if screening has
begun) or /do you plan to use (if you are in the process of adding [condition x]) to screen for
Condition X?

Why did you choose x method?
Probe 1: Discuss why you chose this method.
Probe 2: How long did it take to validate the method for [condition x] or how long do you
anticipate it will take you to validate the method?
Probe 3: Do you use/plan to use a kit? In-house method? Multiplex with another assay?
Probe 4: Describe the screening algorithm for [condition x].
Probe 5: What equipment did your program already have/does have to screen for
[condition x]? What did you have to purchase/anticipate needing to purchase to add
[condition x]? (e.g. equipment, reagents/supplies, other disposables, ancillary equipment,
etc.)
9. Please explain what new equipment you needed to/will need to procure for this method?
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OMB Number (0906-0014)
Expiration Date (09XX/30XX/2018XXXX)

8. (For states that have started screeningIf screening has begun) Describe your experience
with the screening test for [condition x].
Are you getting the outcomes you expected with this method? Please explain why or why
not.
Probe 1: Are you getting the outcomes you expected with this method? Please explain why
or why not.

Probe 2: Have you had to adjust your cutoff? If so, why? Has this changed your outcomes?

Probe 3
Do you have concerns with the method you are using/planning to use? Please elaborate.
Probe 4: Are there any issues/challenges with your method?
Probe 5: Where do you get QA/QC and PT materials? CDC? Other sources?

Probe 6: Will you continue using this method? ExplainPlease elaborate.

DIAGNOSISCONFIRMATORY TESTING AND SHORT-TERM FOLLOW-UP
9. Have you developed a follow up protocol and/or educational materials for [condition x]? If
so please describe itthe steps for short-term follow and how it the plan was developed.
Probe 1: Wwhat confirmatory testing center/lab you have you will used? What
confirmatory testing procedures are done?
Probe 2: Wwill you need to engage specialty/diagnostic centers? If yes, what is the
availability of molecularthe specialty diagnostic centers? What diagnostic testing
procedures are used? molecular genetic sequencing of positive screens? If yes, what is the
availability of molecular diagnostic centers?
Probe 3: aAre the clinical specialists ready for referrals and diagnosis of confirmed positive
screens in newborns? Are there guidelines about how to manage these babies and children
and when treatment should start?

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OMB Number (0906-0014)
Expiration Date (09XX/30XX/2018XXXX)

Probe 4: Discuss the availability of the specialty centers in your state? Rest of the country?
Is that adequate given the expected incidence? How about for treatment centers? Health
care specialists who provide treatment?
a.
10. Are you finding any challenges with follow-up on with regards toof screening results for
conditions x? If so, what are they?
11. Is your program planning to identify and report carriers? If so, please elaborate on the
challenges that may arise.

TIMEFRAME
12. (For states that have started screening) How long did it take your NBS program to initiate
screening for [condition x], from the point you started to consider screening to commencing
screening for all newborns in your state? (Please factor in things such as obtaining authority
to screen, obtaining funding, meeting with advisory committees, setting up the screening
test, updating the LIMS system, preparing follow up staff, preparing specialists in the
community, etc).
12.13. In an attempt to better understand the timeframe for a variousety of implementation
activities, we would like to knowplease describe how long it took/will take you to do the
following (answer options < 1yr., 1-2 yrs., 2-3 yrs. >3 years):
a. Obtain and procure equipment for screening
b. Hire necessary laboratory and follow-up staff
c. Consult with medical staff and specialists
d. Select, develop, and validate the screening test within your laboratory
e. Add the screening test to the existing outside laboratory contract
f. Pilot test the screening process within your state, after validation has taken place
g. Implement statewide screening for all newborns, including full reporting and followup of abnormal screens after validation and pilot testing
h. Entire process from obtaining equipment to implementing statewide screening
(assuming that some activities occurred simultaneously)
Possible timeframes:
o
o
o
o
o

12 months or less
13 to 24 months
25 to 36 months
37 to 48 months
More than 48 months

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OMB Number (0906-0014)
Expiration Date (09XX/30XX/2018XXXX)

13.14. What advice do you have for other state NBS programs in order to ensure smooth and
timely implementation?

PERSONNEL AND FOLLOW-UP
The next few questions are more specific and deal with personnel requirements and follow-up
issues.
14.15. The next few questions are more specific and deal with personnel requirements and
follow-up issues. Do you have staffing concerns with screening for C[condition x] X? If so,
what are they?
16. How many FTEs and what level (education/experience) are needed to add screening for
condition X in your state? (confirm #babies screened/year)
17. do you have for screening for [cCondition x]X (technical only)?
a. Probe 1: If yes, how many FTEs are for laboratory staff, for and for what
position(s)/level(s)?
b. Probe 2: how many Are the FTEs are needed for for laboratory staff, follow up
staff, or both? For what position(s)/level(s)?

18. Do you anticipate needing to hire/add FTEs to screen for [condition x]?
a. Probe 1: If yes, how many FTEs for lab staff, and for what each
position(s)/level(s)?
b. Probe 1: How many Are the FTEs for laboratory staff, follow up staff, or both, for
which position(s)?

15.19.

16. This question pertains to follow-up. Do you have concerns with short-term and long-term
follow up for [cCondition x]X? If so, please describe what are your concerns.?
COSTS
20. Has your program developed cost estimates or a budget analysis to adopt add [condition x]?

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OMB Number (0906-0014)
Expiration Date (09XX/30XX/2018XXXX)

If Yes, are you able to share your ballpark estimates to add screening? (Ask about
marginal start-up costs to add condition - equipment, supplies, FTEs,
confirmatory testing, overhead, other major costs).
a. IF NO, have you had preliminary cost discussions? Are you able to elaborate?
17.21. What do you anticipate will be the greatest cost challenge as it relates to [condition x]?
22. What do you anticipate will be the greatest cost facilitator as it relates to [condition x]?

CONCLUSION
18.23. That concludes the formal part of the interview. Do you have anything else to add?

19.24. Name of respondent, title, how long in position.

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