NHSS Standards Evaluation Report Form

National HIV Surveillance System (NHSS)

Att 3e_SER PS13-1302_final4Nov15

Annual Reporting: Standards Evaluation Report (SER)

OMB: 0920-0573

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Form Approved
OMB No. 0920-0573
Expiration Date: XX/XX/XXXX

National HIV Surveillance System (NHSS)

Attachment 3e.
Standards Evaluation Report Form
Public reporting burden of this collection of information is estimated to average 8 hours 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 D-74, Atlanta,
Georgia 30329; ATTN: PRA (0920-0573).

Form Approved
OMB No. 0920-0573
Exp. Date: XX/XX/XXXX

20XX* Standards Evaluation Report (SER)
PART 1. Process and Outcome Standards for Case Surveillance
Process Standards for Case Surveillance
A. Death Ascertainment
☐ We are a separately funded city AND all death ascertainment is done at the state level. (Skip to section B: Routine
Interstate Duplicate Review (RIDR)).
☐ We are a state, territory, or separately funded city and perform our own death ascertainment. (Respond to the
questions below by completing the tables).
1. Date of Death. In 20XX*, did your surveillance program perform record linkage of HIV case reports with the
following data sources to identify all deaths occurring in 20XX*?
NOTE: You are required to link and load into eHARS vital statistics records AND the SSDMF
Death File
☐ Vital statistics

Linked Deaths Through
what Date (Mo/Yr)?*
(e.g., March 2015,
December 2014, etc.)

All Results
Loaded in
eHARS?

Results Loaded
Manually or Imported?

Choose an
item.

Choose an
item.

☐Yes ☐No

☐ Manually ☐ Imported

Choose an
item.

Choose an
item.

☐Yes ☐No

☐ Manually ☐ Imported

AND
☐ SSDMF

*Enter the end date of the most recent file you linked. For example: In 2015, if you linked a vital statistics file
that included death records from January 2013 to July 2014, you would respond July 2014.
2. Cause of Death. In 20XX*, did your surveillance program perform record linkage of HIV case reports with the
following data sources?
NOTE: At a minimum, you are required to link and load into eHARS the NDI-Plus (if not
prohibited) or, if NDI is prohibited, you are required to link and load a final vital statistics file.
Linked Deaths Through what All Results
Results Loaded
Date (Mo/Yr)?*
Loaded in
Manually or Imported?
Death File
(e.g., July 2012 or if prohibited
eHARS?
by law indicate “Prohibited”)
☐ NDI-Plus

Choose
an item.

Choose
an item.

☐
Prohibited

☐Yes ☐No

☐ Manually ☐ Imported

Choose an
Choose an
☐ Vital
☐Yes ☐No ☐ Manually ☐ Imported
item.
item.
statistics - final
*Enter the end date of the most recent file you linked. For example: In 2015, if you linked a vital statistics file
that included death records from January 2013 to July 2014, you would respond July 2014.
Public reporting burden of this collection of information is estimated to average 8 hours 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 D-74, Atlanta, Georgia 30329; ATTN: PRA (0920-0573).

3. HIV cases not reported to eHARS. In 20XX*, did your surveillance program search all vital records for deaths
mentioning HIV-infection and for which there was no previously reported case in eHARS? ☐ Yes
☐ No
☐ No death record linkage was performed in 20XX*. (Respond to the items directly below).
If you did not meet all three standards in 1, 2, and 3 above, please discuss:
a. Why you did not meet the minimum standards for death record linkage in 20XX*.
b. Your plan to ensure your program meets this standard in 20XX*.

B. Routine Interstate Duplicate Review (RIDR)
☐ We are a separately funded city and all RIDR resolution is done at the state level. (Skip to section C: Laboratory).
☐ We are a state, territory, or separately funded city, and perform our own RIDR resolution. (Please complete the table
below for the January 20XX* and August 20XX* rounds).
Please confirm that you have attached the RIDR progress table to your SER submission. NOTE: please
submit ONLY the progress table. Do NOT send the entire Excel file as it contains personally identifying
information in the tabs. ☐ Yes ☐ No
(Respond to items below).
If ≥ 95%, skip to section C:
Percent of RIDR pairs resolved by
Laboratory.
December 31, 20XX* for RIDR list received
%
January and August 20XX*: (Based on CDCIf <95%, respond to the
supplied RIDR completion report)
questions directly below.
If <95% of the pairs on your RIDR list received in January and August 20XX* were not
resolved by December 31, 20XX*, please discuss:
a. Why you did not completely resolve the RIDR pairs on the January and August 20XX*
lists.
b. Your plan to complete both lists and ensure your program meets this standard in 20XX*.
C. Laboratory
1. In 20XX*, did your surveillance program identify the number of laboratories (in state and out of state
laboratories) that conducted HIV-related testing for providers and facilities in your jurisdiction?
☐ Yes
• Number of laboratories? Click here to enter text.
o Please describe how your program obtained this number.
Click here to enter text.
☐ No
• What is the number of HIV-testing laboratories that reported at least one HIV test result to your program
during 20XX*?
o Number of laboratories: Click here to enter text.

2. Are you aware of any laboratories that conducted HIV-related testing for providers and facilities
within your jurisdiction that did not report any results to your program?
☐ Yes
• Approximately what percentage of your jurisdiction’s patients are missing laboratory results because of this?
Click here to enter text.
☐ No

3. Of the laboratories that reported to your program during 20XX*, are you aware of any laboratories
that did not submit all positive/reactive HIV detection test results, all CD4 results (<200 and ≥200), or all
viral load results (detectable and undetectable)? For example, Laboratory XYZ usually sends 500 viral
load results (both detectable and undetectable) each month. However, during August, undetectable viral
load results were not received from Laboratory XYZ.
☐Yes
•

Approximately what percentage of all test results in a given year is
Click here to
typically reported by this laboratory or laboratories?
enter text.
Approximately what percentage of the test results expected from this
Click here to
laboratory or laboratories in 20XX* was not received?
enter text.
Please describe the expected test results that were not received from this laboratory or
laboratories: Click here to enter text.
After the error was identified, did the laboratory or laboratories report the missing test results
during 20XX*? ☐ Yes ☐ No (If no, skip to question 4)
If the laboratory reported the missing test results, were the test results entered into eHARS
before the December 20XX* data transfer? ☐ Yes ☐ No

•
•
•
•

☐ No
• In 20XX*, did your program monitor the quality of incoming reports of laboratory test results (including test
result volumes) on a quarterly basis or more frequently? ☐ Yes ☐ No

4. Did any other issues arise that prevented your program from receiving all CD4 and viral load results
performed in 20XX*? For example, Laboratory XYZ was transmitting CD4 results via ELR but the
laboratory reports parsed from the HL7 ELR reader/translator were not sent to the HIV Program.
☐ Yes
•

•
•

☐ No

Estimate the percentage of test results that were missing among all CD4 and viral load results performed in
20XX*. Click here to enter text.
Were the issues resolved? ☐ Yes ☐ No (If no, skip to question 5)
If the issues were resolved, were the results entered into eHARS before the December 20XX* data transfer?
☐ Yes ☐ No

5. By December 20XX*, did your surveillance program transfer to CDC via eHARS all CD4 (< 200 and ≥
200) and viral load (detectable and undetectable) test results from laboratory reports received from
20XX*-20XX*?

Year
reports
were
received

Yes

No

CD4 results
If “no”, what
Describe type
% of results
of CD4 results
received have
received (e.g.,
been
All values,
transferred to
<500, <200)
CDC?

Yes

No

Viral load results
If “no”, what Describe type
% of results
of viral load
received have
results
been
received (e.g.,
transferred
Any result,
to CDC?
detectable)

Click here to
%
☐
☐
enter text.
Click here to
%
%
20XX*
☐
☐
☐
☐
enter text.
Click here to
20XX*
%
%
☐
☐
☐
☐
enter text.
*At minimum, reports received from January 20XX* through September 20XX*
20XX*

☐

☐

%

Click here to
enter text.
Click here to
enter text.
Click here to
enter text.

Outcome Standards for Case Surveillance
NOTE: All areas MUST run the CDC-supplied SAS program against the December 20XX* frozen eHARS SAS datasets
to evaluate and report on your program’s outcome standards. In addition, all SAS table output MUST be attached to
your SER submission.

6. Submission of Required SAS Outcome Standard Tables
Please confirm that you have attached the following five SAS outcome tables to your SER submission. I have
attached:
Case ascertainment tables:
Intrastate case duplication rate tables:
Risk factor ascertainment tables:
Completeness of CD4 and VL tables:
Data quality for case surveillance tables:

☐
☐
☐
☐
☐

Yes
Yes
Yes
Yes
Yes

☐
☐
☐
☐
☐

No
No
No
No
No

Measure
Completeness of Case
Ascertainment
Intrastate Duplicate
Review

Risk Factor
Ascertainment

Completeness of Initial
CD4

Completeness of Initial
Viral Load
Data Quality

Data Reporting and
Dissemination

Security and
Confidentiality

Standard
Did your surveillance program ascertain at least (≥) 85% of the
expected number of persons newly diagnosed with HIV infection
in 20XX* by the end of December 20XX*?

Result
%

Were there less than or equal to (≤) 1% duplicate case
reports among all (cumulative) cases reported to your
surveillance program through December 31, 20XX* by the
end of December 20XX*?

%

Did at least (≥) 70% of HIV cases newly reported to your
surveillance program in 20XX* have sufficient risk factor
information to be classified into a known HIV transmission
category by the end of December 20XX*?
Did at least (≥) 60% of adults and adolescents newly diagnosed
with HIV infection in 20XX* have a CD4 count or percent based
on a specimen collected within three months following their initial
diagnosis, reported by the end of December 20XX*?
Did at least (≥) 60% of adults and adolescents newly diagnosed
with HIV infection in 20XX* have a viral load based on a
specimen collected within three months following their initial
diagnosis reported by the end of December 20XX*?
In 20XX*, did 97% of case records pass all selected data edits?
That is, did 97% of case records contain no errors?
In 20XX*, did you develop and disseminate a comprehensive
revision of your integrated HIV Epidemiologic Profile?
In 20XX*, did you develop and disseminate updates to the HIV
Epidemiologic Profile in the form of updates to core
epidemiologic tables and figures, fact sheets, supplemental reports,
slide sets, or other publications (but not a comprehensive
revision)?
In 20XX*, did you develop and disseminate an annual HIV
surveillance report?
Has your program submitted a document (signed by the ORP)
certifying that in 20XX* your program was in full compliance
with the Data Security and Confidentiality Guidelines for HIV,
Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis
Programs: Standards to Facilitate Sharing and Use of
Surveillance Data for Public Health Action (2011)?
In 20XX*, did all persons with access to any HIV surveillance
data (including all IT personnel with access to eHARS or other
HIV surveillance databases) complete an annual security and
confidentiality training and sign a confidentiality statement?
Did your program conduct the required annual review of your
written security and confidentiality policies and procedures to
assess whether changes in legislation, technology, or priorities,
personnel, or other situations require changes in policies and
procedures?
While under FOA PS13-1302 has your program completed (or
participated in the completion of) an initial assessment across
relevant programs to identify policy and environmental needs for
implementing the Data Security and Confidentiality Guidelines for
HIV, Viral Hepatitis, Sexually Transmitted Disease, and
Tuberculosis Programs: Standards to Facilitate Sharing and Use
of Surveillance Data for Public Health Action (2011)?

%

%

%

%
Yes

No

☐

☐

☐

☐

☐

☐

☐

☐

☐

☐

☐

☐

☐

☐

PART 2. Process and Outcome Standards for HIV Incidence Surveillance (HIS)
(Only for Areas Conducting HIS)
Please indicate if you used HIS funds only, case surveillance funds only, or both HIS and case surveillance funds to
conduct HIS activities for 20XX*.
☐ HIS funds only

☐ Case funds only

☐ Both HIS and case funds

NOTE: All areas MUST use the CDC-supplied SAS program against the December 20XX* frozen SAS datasets to
evaluate and report your program’s testing treatment history (TTH) and serologic testing algorithm for recent HIV
seroconversion (STARHS) result completeness. Please confirm that you have attached:
Incidence Completeness Report:
Incidence Data Quality Report:
Measure
Completeness of
Testing and
Treatment History
(TTH)
Completeness of
STARHS Result

Data Quality

☐ Yes
☐ Yes

☐ No. (Respond to items below).
☐ No. (Respond to items below).

Standard
For cases diagnosed in 20XX*, did at least (≥) 85% have testing
and treatment history (TTH) data entered in eHARS by the end of
December 20XX* (see line 10 of the Incidence Completeness
Report)?
For cases diagnosed in 20XX* (excluding AIDS cases diagnosed
within 6 months), did at least (≥) 60% have a valid STARHS
result from a specimen that was collected within 3 months of HIV
diagnosis entered by the end of December 20XX* (see line 14 of
the Incidence Completeness Report)?
In 20XX*, did 97% of case records pass all selected data edits
related to HIS data (see line 3 of the Incidence Data Quality
Report)?

Result
%

%

%

OPTIONAL ACTIVITIES

PART 3. Molecular HIV Surveillance (MHS)
(Only for Areas Conducting MHS)
Please indicate if you used MHS funds only, case surveillance funds only, or both MHS and case surveillance funds
to conduct MHS activities for 20XX*.
☐ MHS funds only

☐ Case funds only

☐ Both MHS and case funds

Process Measures for MHS Surveillance

In 20XX*, did your program identify all laboratories that conduct HIV genotypic resistance
testing for providers and facilities in your jurisdictions?
☐ Yes
• Number of laboratories? Click here to enter text.
• Please describe how your program obtained this number. Click here to enter text.
☐ No
• What is the number of laboratories that reported at least one HIV nucleotide sequence
to your program during 20XX*? Click here to enter text.
In 20XX*, did your program identify any laboratories that conduct HIV genotypic resistance
testing for providers and facilities within your jurisdiction that did not report all HIV
nucleotide sequences to your program?
☐ Yes
• Approximately what percentage of HIV nucleotide sequences in a given year is
typically reported by this laboratory or laboratories? Click here to enter text.
• Approximately what percentage of the HIV nucleotide sequences expected from this
laboratory or laboratories in 20XX* was not received? Click here to enter text.
☐ No
Process
In 20XX*, did your program validate HIV nucleotide sequence data received from
laboratories?
In 20XX*, did your program transfer to CDC via eHARS all HIV nucleotide sequence
data received from laboratories in 20XX*-20XX?*
20XX*
20XX*
Year of diagnosis
20XX*
In 20XX*, did your program establish or improve processes to collect ARV use history
data for all persons newly diagnosed with HIV infection?

Result
Yes Yes
☐

☐

☐
☐
☐

☐
☐
☐

☐

☐

*For 20XX*, at a minimum, sequences received from January 20XX* through September 20XX*.

Outcome Standards for MHS Surveillance
HIV nucleotide sequence data completeness and antiretroviral (ARV) use history data completeness should be assessed
using molecular HIV surveillance data entered through December 31, 20XX* and the SAS program provided by CDC.
Please confirm that you have attached the MHS SAS outcome table to your SER submission.
☐ Yes
☐ No
Measure
Completeness of
Initial HIV
Nucleotide
Sequence
Completeness of
ARV Use History

Standard
For cases diagnosed in 20XX*, did at least (≥) 50% of newly
diagnosed persons have an initial HIV nucleotide sequence (i.e.,
obtained from a specimen collected for HIV genotype [resistance]
testing within 3 calendar months following HIV diagnosis) in
eHARS by the end of December, 20XX*?
For cases diagnosed in 20XX*, did at least (≥) 85% of newly
diagnosed persons with an initial HIV nucleotide sequence have
ARV use data in eHARS by the end of December 20XX*?

Result

%

%

PART 4. Perinatal HIV Exposure Surveillance
(Only for Areas that Conducted PHERS)
Please indicate if you used case surveillance funds to conduct Perinatal HIV Exposure Surveillance for 20XX*.
Yes
☐ No
Process
In 20XX*, did your program conduct active and passive surveillance on perinatal HIV
exposure, including medical record review for opportunistic infections, adverse
outcomes of ARV exposure, and linkage to birth registries?
In 20XX*, did your program conduct active and passive surveillance on HIV-infected
women?

Result
Yes No
☐

☐

☐

☐

PART 5. Geocoding and Data Linkage (GDL)
(Only for Areas that Conducted GDL Activities)
Please indicate if you used case surveillance funds to conduct Geocoding and Data Linkage activities for 20XX*.
☐ Yes
☐ No
Process
Did your program collect HIV surveillance information according to routine surveillance
procedures, including local street address, city, and state of residence at diagnosis, for
each newly diagnosed HIV case?
Did your program have a Memorandum of Agreement (MOA) for the 5-year funding
period in place?
Did your program apply geocoding standards provided by CDC, including cleaning and
standardizing the data and the collection of variables derived from the geocoding
process?
Did your program geocode, to the census tract level, residence at HIV disease diagnosis
information for cases diagnosed in 20XX* per CDC guidance?
Did your program report data to CDC?

Result
Yes No
☐

☐

☐

☐

☐

☐

☐

☐

☐

☐

*NOTE TO OMB REVIEWERS: Year indicators of “XX”* will be updated annually to reflect the new
measurement period.

☐


File Typeapplication/pdf
File TitlePlease report on your progress towards meeting HIV Surveillance Process and Outcome Standards listed below
AuthorR. Luke Shouse
File Modified2016-01-08
File Created2015-11-16

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