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Congenital Syphilis PoC Testing Supplement

ICR 202607-0920-006 · OMB 0920-1282 · Object 171148600.

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Congenital Syphilis PoC Testing Supplement
Evans, Lindsey (CDC/NCHHSTP/DSTDP)
Calc
2026-06-26
2026-07-24
complete

Extracted Text

Congenital Syphilis Point-of-Care Testing Supplement — Pe
Reporting Period: July 1, 2026 – February 28, 2027 | Due: May 31, 2027

Recipient / Jurisdiction Name
Reporting Period July 1, 2026 – February 28, 2027
Report Submission Date

SECTION 1 — Procurement (Financial Measures)
First, indicate whether your program can distinguish purchases made with supplement funds from purchases made with ot
Can your program distinguish purchases made with supplement funds from purchases made with other funds?
Table A — Supplement vs. Other Funds (complete if
you answered Yes)
Item

1a. Syphilis POCTs

Purchased
with
Supplement
Funds

Purchased with
Other Funds

1b. Other syphilis tests (non-POCT, e.g., RPR, TPPA,
EIA)
1c. Syphilis treatment medications (e.g., Bicillin L-A)

Table B — Total All Funds (complete if you answered No)
Item

Total Purchased (All Funds)

1a. Syphilis POCTs

1b. Other syphilis tests (non-POCT)

1c. Syphilis treatment medications (e.g., Bicillin L-A)

⚑ Section 1 Data Quality
Are there any data quality issues?
Describe the issue(s):
Steps taken to address:

No

Additional context for CDC:

SECTION 2 — Syphilis Testing Activity (Programmatic Measures)
Report ALL syphilis POCTs conducted at your site(s) during the period, regardless of funding source. Data source: testing log
Measure

Women of Reproductive
Age (15–44)

Total

2a. POCTs performed — Clinical / STD Clinic

2b. POCTs performed — Prenatal / OB Setting
2c. POCTs performed — Community / Outreach
Setting
2d. POCTs performed — Emergency Department

2e. POCTs performed — Partner Services Field Test
2f. POCTs performed — Other (specify venue in Data
Source)
2g. TOTAL POCTs Performed (sum of 2a–2f)

0

⚑ Section 2 Data Quality
Are there any data quality issues?

0

Select

Describe the issue(s):
Steps taken to address:
Additional context for CDC:

SECTION 3 — POCT Results & Confirmatory Testing

Source: LIS or requisition form records. Each reactive POCT should be linked to a confirmatory serologic result where availab
Measure

3a. Number of reactive (positive) POCT results
3b. Of reactive POCTs: number with a confirmatory
test ordered
3c. Of confirmatory tests ordered: number
confirmed positive (true positive)

Total Count

Women of Reproductive
Age (15–44)

3d. Of confirmatory tests ordered: number
confirmed negative (false positive POCT)
3e. Of confirmatory tests ordered: number with
result pending or unknown
3f. Check: 3c + 3d + 3e should equal 3b

0

⚑ Section 3 Data Quality
Are there any data quality issues?

0

Select

Describe the issue(s):
Steps taken to address:
Additional context for CDC:
SECTION 4 — Case Identification & Treatment Outcomes (Women)
Source: Disease case records, EHR, or STD surveillance system. Count only cases identified and treated during the period of
Measure

Count

Auto-Calculated Proportion

— (reference total)

4a. Women with newly diagnosed syphilis (any
stage)
4a-i. Of those: women of reproductive age (15–44)

—

4a-ii. Of those: pregnant women

—

4b. Women completely and correctly treated for
syphilis

—

4b-i. Of those: pregnant women completely and
correctly treated

—

⚑ Section 4 Data Quality
Are there any data quality issues?

Select

Describe the issue(s):
Steps taken to address:
Additional context for CDC:
SECTION 5 — Qualitative Supplement Impact (Required for All Recipients)

Responses should be 2–5 sentences each. These questions allow you to describe supplement impact regardless of data trac

5a. How did the supplement funding change or expand your program's syphilis POCT capacity compared to before the su

5b. Were there any barriers to using supplement-purchased POCTs or treatment medications during this period? If so, h

5c. Is there anything else you would like CDC to know about your program's supplement activities or outcomes not capt

CDC estimates the average public reporting burden for this collection of information as 3 hours annually, including the time for review
collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of informatio
including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, At

Form Approved
OMB Control Number: 09201282
Expiration Date:
MM/DD/YYYY

e Testing Supplement — Performance Measure Report

ruary 28, 2027 | Due: May 31, 2027 (within 90 days of period end)

027

nt funds from purchases made with other funds. Your answer determines which table to complete below.

ases made with other funds?

sed (All Funds)

Yes
ACTIVE

Total
Purchased

Data Source

Reporting Mechanism

0

e.g., Purchase orders,
procurement system…

0

e.g., Lab ordering records,
e.g., Exported lab order log;
EHR procurement module… summed by test type…

0

e.g., Pharmacy procurement e.g., Pharmacy system
records, clinic supply logs… export; specify unit type…

Data Source

Unit of measure for procured te

e.g., Pulled from finance
system; filtered by fund
code…

Reporting Mechanism

e.g., All procurement or
purchase order records…

e.g., Total POCT units
procured July 1–Feb 28, all
fund sources…

e.g., All procurement or lab
ordering records…

e.g., Total non-POCT syphilis
tests procured, all fund
sources…

e.g., All pharmacy or clinic
procurement records…

e.g., Total doses/units
procured; specify unit type…

Unit of measure for procured te

unding source. Data source: testing logs, EHR, or disease surveillance system.
Pregnant Women

Data Source

Reporting Mechanism

e.g., Clinic EHR, testing log…

e.g., Exported from EHR by
test type and visit date…

Other Notes

e.g., Pulled prenatal visit
e.g., OB/prenatal clinic EHR,
records filtered by POCT
LIS…
order…
e.g., Outreach program log…

e.g., Manual tally from
outreach activity reports…

e.g., ED information system, e.g., ED EHR query by test
LIS…
order code and date range…
e.g., Partner services field
test log, EHR, LIS, or DIS
activity records…

e.g., Matched field test
activity records by venue,
test type, and date range…

e.g., Program-specific
tracking system…

0 Auto-calculated from rows above

firmatory serologic result where available.
Pregnant Women

Total Proportion

WRA Proportion

Pregnant Proportion

— (reference total)

— (WRA reference total)

— (Pregnant reference total)

—

—

—

—

—

—

—

—

—

—

—

—

Reporting Mechanism

Other Notes

0

tified and treated during the period of performance.

-Calculated Proportion

— (reference total)

Data Source

e.g., STD surveillance system, e.g., Queried system for new
case registry…
female syphilis cases in
period…

—

e.g., Surveillance system
filtered by age 15–44…

e.g., Applied age filter to 4a
query…

—

e.g., Case records with
pregnancy flag…

e.g., Applied pregnancy
status filter to 4a query…

—

e.g., EHR treatment record… e.g., Filtered case records for
completed treatment
regimen…

—

e.g., Case management
records with pregnancy +
treatment flags…

plement impact regardless of data tracking limitations.

e.g., Cross-referenced
diagnosed pregnant women
with treatment records…

CT capacity compared to before the supplement period?

medications during this period? If so, how did your program address them?

ement activities or outcomes not captured by the measures above?

ours annually, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/informa
red to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate
w Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1282)

*Use unique identifier provided

it of measure for procured tests/medications (e.g., unit, test kit, vial, dose)

it of measure for procured tests/medications (e.g., unit, test kit, vial, dose)

Data Source

Reporting Mechanism

e.g., LIS reactive result query…

e.g., Filtered LIS by reactive result and
test date range…

e.g., LIS order records linked to
reactive POCT results…

e.g., Matched reactive POCT records to
follow-up test orders…

e.g., Confirmatory serologic result…

e.g., Pulled linked confirmatory results;
filtered positive…

Other Notes

e.g., Confirmatory serologic result…

e.g., Pulled linked confirmatory results;
filtered negative…

e.g., LIS pending queue…

e.g., Counted orders with no result
entered as of report date…

Internal consistency check — autocalculated for total, WRA, and
pregnant strata

and maintaining the data/information needed, and completing and reviewing the
ts regarding this burden estimate or any other aspect of this collection of information,

⚑ Data Quality Dashboard

Automatically checks entered data for logical inconsistencies and flags potential issues. Review warnings/errors before sub
Errors (must fix)

Warnings (review)

Checks Passed

0

2

15

Section

Check

Status

Severity

Header

Recipient name entered

Warning

Warning

Header

Submission date entered

Warning

Warning

Section 1

Funding distinction selected

Pass

OK

Section 1

Active procurement table has quantities

Warning

Warning

Section 1 DQ

If issue flagged, description provided

Pass

OK

Section 2

At least one POCT count entered

Warning

Warning

Section 2

Row 2a subgroups do not exceed total

Pass

OK

Section 2

Row 2b subgroups do not exceed total

Pass

OK

Section 2

Row 2c subgroups do not exceed total

Pass

OK

Section 2

Row 2d subgroups do not exceed total

Pass

OK

Section 2

Row 2e subgroups do not exceed total

Pass

OK

Section 2

Row 2f subgroups do not exceed total

Pass

OK

Section 2 DQ

Pass

OK

Pass

OK

Pass

OK

Pass

OK

Section 3 DQ

If issue flagged, description provided
3b confirmatory orders do not exceed 3a reactive
POCTs by stratum
3c+3d+3e aligns with 3b by stratum
Reactive POCTs do not exceed total POCTs
performed by stratum
If issue flagged, description provided

Pass

OK

Section 4

4a newly diagnosed women entered

Warning

Warning

Section 4

4a-i and 4a-ii do not exceed 4a

Pass

OK

Section 4

4b treated does not exceed 4a diagnosed
4b-i treated pregnant does not exceed diagnosed
pregnant
If issue flagged, description provided

Pass

OK

Pass

OK

Pass

OK

Section 3
Section 3
Cross-Section

Section 4
Section 4 DQ

iew warnings/errors before submission.

Detail

Please enter the jurisdiction or recipient name.
Please enter the report submission date.
Funding distinction selected: Yes
Enter at least one quantity in the active Section 1 table, or
leave zero only if accurate.
Section 1 DQ response complete
All Section 2 venue counts are blank/zero.
WRA/pregnant counts are within total for row 2a
WRA/pregnant counts are within total for row 2b
WRA/pregnant counts are within total for row 2c
WRA/pregnant counts are within total for row 2d
WRA/pregnant counts are within total for row 2e
WRA/pregnant counts are within total for row 2f
Section 2 DQ response complete
3b is within 3a for total, WRA, and pregnant strata
Confirmatory outcomes align with 3b for all strata
3a is within Section 2 POCT totals for all strata
Section 3 DQ response complete
No newly diagnosed women entered in 4a.
Subgroups are within 4a
4b is within 4a
4b-i is within 4a-ii
Section 4 DQ response complete

How to resolve

Type

Complete Report Form cell B4.

Header

Complete Report Form cell B7.

Header

Select Yes or No in Report Form cell F11.

Section 1

Enter quantities in active Table A or Table B.

Section 1

Describe the Section 1 issue in the text field.

DQ

Enter POCT counts for at least one venue, or verify
Warning
zero.
Correct subgroup counts so each is less than or
Pass
equal to total.
Correct subgroup counts so each is less than or
Pass
equal to total.
Correct subgroup counts so each is less than or
Pass
equal to total.
Correct subgroup counts so each is less than or
Pass
equal to total.
Correct subgroup counts so each is less than or
Pass
equal to total.
Correct subgroup counts so each is less than or
Pass
equal to total.
Describe the Section 2 issue in the text field.
Pass
Reduce 3b or review 3a for the affected stratum.
Correct Section 3 outcome counts by stratum or
explain in DQ.
Review Section 2 totals or Section 3 reactive
counts.
Describe the Section 3 issue in the text field.

Pass

Enter count in 4a, or verify zero.
Correct subgroup counts so they are less than or
equal to 4a.
Correct treatment count or diagnosed count.
Correct Section 4 pregnant treatment or diagnosis
counts.
Describe the Section 4 issue in the text field.

Warning

Pass
Pass
Pass

Pass
Pass
Pass
Pass