CDC Newborn Screening Quality Assurance Program – Spinal Muscular Atrophy (SMA) Proficiency Testing (PT) Pilot
OSTLTS Generic Data collection Request
OMB No. 0920-0879
Program Official/Project Officer
John Bernstein, MS, PMP
Quality Manager
Newborn Screening and Molecular Biology Branch
4770 Buford Highway, Atlanta, GA 30341
770.488.0973
Yfj5@cdc.gov
Section B – Data collection Procedures 3
1. Respondent Universe and Sampling Methods 3
2. Procedures for the Collection of Information 3
3. Methods to Maximize Response Rates Deal with Nonresponse 4
4. Test of Procedures or Methods to be Undertaken 4
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 4
It is expected that there will be 40 participants. These participants are clinical laboratory technologists/technicians from public health labs that perform newborn screening and/or develop newborn screening tests. PHLs that have contacted CDC in the past 12 months inquiring about a SMA PT service will be invited to participate.
Respondents will be recruited through an invitation email (see Attachment D – Pilot SMA PT Email Invitation) to the respondent universe. Respondents will have 2 weeks to indicate their willingness to participate. Two business days before shipment, respondents who request to participate will receive a notification email that will explain:
The purpose of the data collection, and why their participation is important
Instructions for participating
Method to safeguard their responses
That participation is voluntary
The expected time to complete the instruments
Data will be collected via electronic spreadsheets (see Attachment A – Pilot SMA PT Reporting Form and Attachment B – Pilot SMA PT Feedback Form) sent as attachments to an email notification (see Attachment G – Pilot SMA PT Email Packet) 2 days before shipment of PT panels. Participants will have 4 weeks to complete and return the data. A reminder email (see Attachment F – SMA Pilot PT Email Reminder) will be sent to participants who have not submitted data 1 week before the participation deadline.
Data analysis will involve simple as well as categorical statistics. Individual respondents will receive an evaluation of their performance (actual versus expected outcome per PT specimen). This evaluation will not be shared with any other participant. All participants will receive an event summary report containing aggregate statistical data (aggregate PT outcomes). The use of custom Lab IDs known only to CDC and respondent maintains confidentiality of the data. A summary report of the aggregate interval scale feedback will be provided to CDC program staff in order to inform program improvements.
Although participation in the data collection is voluntary, the project team will make every effort to maximize the rate of response. Labs that had previously requested and/or shown interest in this service are included as participants in the pilot, which is expected to increase response rates. The data collection instruments were designed to limit questions to collect only required information with the minimum number of free-response questions, thereby minimizing response burden.
Two business days before shipping the PT panels, an email notification will be distributed (see Attachment G – Pilot SMA PT Email Packet) containing the data reporting form (see Attachment A – Pilot SMA PT Data Reporting Form), customer service feedback form (see Attachment B – Pilot SMA PT Feedback Form) and instruction sheet (see Attachment C – Pilot SMA PT Instructions). Respondents will have 20 business days to complete the instrument. Those who do not respond within 15 business days will receive a reminder email (see Attachment F – Pilot SMA PT Email Reminder) urging them to complete the instruments. Those who do not respond within 5 business days from the reminder email will be considered non-responders.
Pilot SMA PT Data Collection Form
The estimate for burden hours is based on a pilot test of the Data Reporting Form (Attachment A) by 2 of public health professionals. In the pilot test, the average time to complete the instrument including time for reviewing instructions, gathering needed information and completing the instrument, was approximately 8.6 minutes (range: 7 –10). For the purposes of estimating burden hours, the upper limit of this range (i.e., 10 minutes) is used.
Pilot SMA PT Feedback Form
The estimate for burden hours is based on a pilot test of the Feedback Form (Attachment B) by 2 of public health professionals. In the pilot test, the average time to complete the instrument including time for reviewing instructions, gathering needed information and completing the instrument, was approximately 2.5 minutes (range: 2 –3). For the purposes of estimating burden hours, the upper limit of this range (i.e., 3 minutes) is used.
Miyono Hendrix
Research Biologist
CDC: Newborn Screening and Molecular Biology Branch
4770 Buford Highway, Atlanta GA 30341
770.488.4767
Nicolle Baird
Biologist
CDC: Newborn Screening and Molecular Biology Branch
4770 Buford Highway, Atlanta GA 30341
404.498.5701
John Bernstein
Quality Manager
4770 Buford Highway, Atlanta GA 30341
770.488.0973
Suzanne Cordovado, PhD
Lab Chief
4770 Buford Highway, Atlanta GA 30341
770.488.4048
Snc4@cdc.gov
Note: Attachments are included as separate files as instructed.
Attachment A – Pilot SMA PT Data Reporting Form
Attachment B – Pilot SMA PT Feedback Form
Attachment C – Pilot SMA PT Instructions
Attachment D – Pilot SMA PT Email Invitation
Attachment F – Pilot SMA PT Email Reminder
Attachment G - Pilot SMA PT Email Packet
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | khx2 |
| File Modified | 0000-00-00 |
| File Created | 2021-01-13 |