Standard Evaluation Report (track changes) 24HX

Att 3d_Standards Evaluation Report Form (SER)_tracked.docx

[NCHHSTP] National HIV Surveillance System (NHSS)

Standard Evaluation Report (track changes) 24HX

OMB: 0920-0573

Document [docx]
Download: docx | pdf

Form Approved OMB No. 0920-0573

Exp. Date: 2/28/2026


<Year> Standards Evaluation Report (SER)


Surveillance Program Performance


Jurisdiction’s name: ______________________


Provide the following:

Name

email

  1. Primary Surveillance Contact:



  1. Secondary Surveillance Contact:



  1. S&C Overall Responsible Party:




A. Death Ascertainment


We are a separately funded city AND all death ascertainment is done at the state level. (Skip to section B: Laboratory).

We are a state, territory, or separately funded city and perform our own death ascertainment. (Respond to the questions below and complete the table).


Vital records

Standard

Result

1. Frequency of linkages done in <Year-1> and entered in eHARS:

Annual

will increase to semiannual on 2026 SER and quarterly on 2028 SER


2. Linked with deaths occurring through:

December <Year-2>

MM/YYYY

3. Linkages included dates of death for ALL cases and entered in eHARS?

Yes


4. Linkages included causes of death for ALL cases and imported in eHARS?

Yes


5. Searched all vital records deaths mentioning HIV and entered previously unreported cases in eHARS?

Yes



For unmet vital records standards provide an explanation for why each standard was not met and plans for meeting it in the future. (will only appear if there are unmet standards)


6. Are you prohibited from searching the National Death Index (NDI) by state, local, or territorial law?

Yes No


Shape1

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).



If No to Q6:


Standard

Result

NDI Early-release version



7. Linked with deaths occurring through:

December <Year-2>

MM/YYYY

NDI Final version



8. Linked with deaths occurring through:

December <Year-3>

MM/YYYY

Social Security Death Master File (SSDMF)



9. Last year linked with SSDMF

At least once during <Year-1> - <Year-5>*


10. If linked in <Year-1>, linked with deaths occurring through:

December <Year-2>

MM/YYYY

*If unable to link with NDI during <Year-1>, then a linkage to SSDMF is required in <Year-1>. If able to link with NDI, then refer to the Standard indicated in the table.


If Yes to Q6


Standard

Result

NDI



11. Last year you consulted with legal counsel to reassess determination to prohibit linking to the NDI:

At least once during <Year-1> - <Year-5>


12. If legal counsel was consulted in <Year-1>, upload documentation of assessment

documentation


Social Security Death Master File (SSMDF)



13. Linked with deaths occurring through:

December <Year-2>

MM/YYYY


For unmet NDI standards provide an explanation for why the standard was not met and plans for meeting it in the future (will only appear if there are unmet standards)


For unmet SSDMF standards provide an explanation for why the standard was not met and plans for meeting it in the future (will only appear if there are unmet standards)





B. Laboratory



Standard

Result

1. In <Year-1>, did your program review and update the list of laboratories that perform HIV-related laboratory tests that should be reported to your program?

Yes


2. In <Year-1>, did your program review and update, as necessary, all laboratory reporting/processing/importing tools (e.g., SAS code)?

Yes


3. Last year a laboratory assessment of all laboratories that report to the health department was conducted including maintenance of documentation on the types of tests performed by each laboratory identified in the laboratory assessment including use of ambiguous LOINCs (Logical Observation Identifiers Names and Codes) by different labs:

At least once during <Year-1> - <Year-5>


4. Frequency that the CDC-supplied SAS program (or equivalent program) was run to monitor lab data quality and volume entered in eHARS for each laboratory and test type and respond as needed:

Monthly



For unmet laboratory process standards provide an explanation for why the standard was not met and plans for meeting it in the future. (there will be a separate text box for each unmet standard that will only appear if the standard was not met)



5. Are you aware of any lapses in laboratory reporting of HIV-related test results for persons who reside within your jurisdiction that resulted in missing laboratory data in your December <Year-1> data transfer to CDC?

Yes

Year of specimen collection

Approximately what percentage of your total jurisdiction’s laboratory volume is missing for the calendar year indicated?

Approximately what percentage of your total jurisdiction’s CD4 results (< 200 and ≥ 200) and viral load results (detectable and undetectable) are missing for the calendar year indicated?

<Year-1>*



<Year-2>



*At a minimum, lab results through September 2023

No


6. Describe how your program has expanded or plans to expand electronic data exchange capacity for laboratory data as well as other sources of data (e.g. electronic medical records).


C. Pediatric/Perinatal


Birth Ascertainment

1A. In <Year-1>, did you link case reports for persons with diagnosed HIV infection whose assigned sex at birth is not male to the birth certificate data file from the vital records office for all <Year-2> births to identify all perinatally exposed infants with a residence of birth in your jurisdiction?


Yes

No


1B. If no to 1A, please describe why you did not link with the birth certificate data file.

[Free text]


1C. If yes to 1A, did you enter all the information identified from the linkage to the birth certificate data file in eHARS before your final December <Year-1> data transfer to CDC?


Yes

No


1D. If no to 1C, please describe why you did not enter in eHARS all the information identified from the link to the birth certificate data file.

[Free text]


Number of perinatally HIV exposed infants for birth year <Year-2>

2A. Provide the number of perinatally HIV exposed infants born in <Year-2> that were identified through the match to birth certificates. *This should include exposed infants previously known to the HIV surveillance program.


2B. Does this match with the number of perinatally exposed infants reported to CDC through your final December <Year-1> data transfer?


Yes

No


2C. If this does not match, please describe the reasons the numbers do not match (e.g., X perinatally exposed infants reported to health department that were not in the state/local birth certificate data because the infant was a resident of another jurisdiction).



Perinatal HIV Exposure Reporting*

3. Provide percentage of perinatally HIV-exposed infants born in <Year-3> who have HIV infection status determined by 18 months of age (Standard: 85%):

*Required for California, Chicago, District of Columbia, Florida, Georgia, Houston, Los Angeles, Louisiana, Maryland, Mississippi, New Jersey, New York City, North Carolina, Ohio, Philadelphia, Tennessee, and Texas. All others are encouraged to respond but are not required.


D. Geocoding and Data Linkage



Standard

Result

1. In <Year-1>, how frequently did your program geocode addresses in eHARS to the census tract level and ensure the census tract is populated in eHARS?

Quarterly


2. In <Year-1>, did your program submit linked American Community Survey (ACS) data within 30 days of the availability of the ACS data? (will only appear if the jurisdiction does not send census tracts to CDC)

Yes



For all unmet geocoding and data linkage standards provide an explanation why the standard was not met and plans for meeting it in the future. (will only appear if there are unmet standards)


E. Cluster Detection



Standard

Result

1. In <Year-1>, how frequently did your program analyze molecular data by using CDC-recommended approaches to identify HIV clusters and outbreaks?

Monthly


2. In <Year-1>, how frequently did your program conduct time-space analysis by using CDC-recommended approaches to identify HIV clusters and outbreaks?

Monthly



For unmet cluster detection standards provide an explanation why the standard was not met and plans for meeting it in the future. (will only appear if there are unmet standards)


F. Monthly eHARS Data Transfer to CDC



Standard

Result

1. At minimum, conduct an end-of-month transfer of the eHARS data file to CDC by the established deadline (no later than 10am ET 3 business days before the end of each calendar month).

12 on-time monthly submissions

Populated by CDC


If the standard was not met, provide an explanation why the standard was not met and plans for meeting it in the future. (will only appear if there are unmet standards)


G. HIV Surveillance Policies and Procedures



Standard

Result

1. Last year the HIV surveillance program policies and procedures were reviewed and update document and train as needed.

<Year-1>



If the standard was not met, provide an explanation why the standard was not met and plans for meeting it in the future. (will only appear if there are unmet standards)


H. Data Quality Outcome Standard


Standard

Result

1. Of all persons with HIV infection diagnosed during <Year-2>, at least (≥) 97% have been reported to CDC (i.e., pass all standard data edit checks), assessed December <Year-1>

Upload the SAS output: [upload field]



If the standard was not met, provide an explanation why the standard was not met and plans for meeting it in the future. (will only appear if there are unmet standards)


I. Outcome Standards Calculated at CDC


NOTE: Below your program’s results have been pre-populated for the outcome standards based on your December <Year-1> data transmission to CDC.


Completeness and Timeliness of Case Ascertainment

Standard

Result

Of the expected number of persons whose HIV infection was diagnosed during <Year-2>, at least (≥) 95% are reported in eHARS, assessed December <Year-1>


Of the expected number of persons whose HIV infection was diagnosed during <Year-2>, at least (≥) 90% are reported in eHARS within (≤) 90 days of the diagnosis, assessed December <Year-1>


Of all persons with diagnosed HIV infection whose diagnoses were first entered in eHARS during <Year-1>, at least (≥) 75% were first entered within (≤) 60 days after the date of diagnosis.

This measure will change starting on the 2027 SER to: Of all persons with diagnosed HIV infection whose diagnoses were first entered in eHARS during <Year-1>, at least (≥) 75% were first entered with (≤) 30 days after the date of diagnosis.



Duplicate Review

Standard

Result

Of all persons with diagnosed HIV infection who were entered in eHARS through the end of <Year-1> (cumulative), less than or equal to (≤) 1% have duplicate case reports, assessed December <Year-1>


Of all pairs on the Routine Interstate Duplicate Review (RIDR) list received January <Year-1>, at least (≥) 98% were resolved by June 30, <Year-1>


Of all pairs on the Routine Interstate Duplicate Review (RIDR) list received July <Year-1>, at least (≥) 98% were resolved by December 31, <Year-1>


Of all pairs on the Cumulative Interstate Duplicate Review (CIDR) list received January <Year-1>, at least (≥) 98% were resolved by December 31, <Year-1>

First assessed on the 2026 SER


Completeness of Laboratory Reporting

Standard

Result

Of all CD4 laboratory test results with a specimen collected during <Year-2>, the total volume of (deduplicated) CD4 test results was at least (≥) 95% of the median annual volume of (deduplicated) CD4 test results from the previous 3 years, assessed December <Year-1>.


Of all viral load laboratory test results with a specimen collected during <Year-2>, the total volume of (deduplicated) viral load test results was at least (≥) 95% of the median annual volume of (deduplicated) viral load test results from the previous 3 years, assessed December <Year-1>.


Of all persons with HIV infection diagnosed during <Year-2>, at least (≥) 60% have an analyzable nucleotide sequence, assessed December <Year-1>



Timeliness of Laboratory Reporting

Standard

Result

Of all CD4 and viral load results entered in eHARS during <Year-1>, at least (≥) 90% are entered within (≤) 30 days after the specimen collection date.


Of all diagnostic results entered in eHARS during <Year-1>, at least (≥) 90% were entered within (≤) 60 days after the date of specimen collection.

This measure will change starting on the 2027 SER to: Of all diagnostic results entered in eHARS during <Year-1>, at least (≥) 90% were entered within (≤) 30 days after the date of specimen collection.


Of all sequences entered in eHARS during <Year-1>, at least (≥) 85% were entered within (≤) 60 days after the date of specimen collection.



Validity of Laboratory Results

Standard

Result

Of all laboratory test results entered in eHARS during <Year-1>, at least (≥) 97% have a valid test result and a known specimen collection date (month and year), assessed December <Year-1>.



Death Ascertainment

Standard

Result

Of all deaths that occurred during <Year-2>, at least (≥) 85% have an underlying cause of death, assessed December <Year-1> 


Of all deaths entered in eHARS during <Year-1> with vital statistics as one of the document sources, at least (≥) 90% of the deaths were entered within 4 calendar months of the date of death, assessed December <Year-1>.

First assessed on the 2028 SER


Risk Factor Ascertainment

Standard

Result

Of all persons with diagnosed HIV infection who were first entered in eHARS during <Year-2>, at least (≥) 80% have sufficient risk factor information to be classified into a known transmission category, assessed December <Year-1>.

This measure will change starting on the 2028 SER to: Of all persons with diagnosed HIV infection who were first entered in eHARS during <Year-2>, at least (≥) 85% have sufficient risk factor information to be classified into a known transmission category, assessed December <Year-1>.



Address Ascertainment

Standard

Result

Of all persons entered in eHARS with HIV diagnosed in <Year-2> (regardless of residence at diagnosis), at least (≥) 97% have a valid county FIPS code for the residence at diagnosis, assessed December <Year-1>.


Of all persons entered in eHARS who were living with diagnosed HIV infection at the end of <Year-2> (regardless of jurisdiction of residence), at least (≥) 97% have a valid county FIPS code for the residence at the end of <Year-2>, assessed December <Year-1>.


Of persons living with diagnosed HIV infection in the jurisdiction at the end of <Year-1>, at least (≥) 95% have a current address with a date that is in <Year-5> or later.



Completeness of Previous Negative HIV Test

Standard

Result

Of all persons with HIV infection diagnosed during <Year-2>, at least (≥) 70% have a known value for previous negative HIV test result (self-reports or documented), assessed December <Year-1>. 


Of all persons with HIV infection diagnosed during <Year-2> who have a previous negative test result (self-reported or documented), at least (≥) 50% have a valid date of documented negative test result, assessed December <Year-1>.



Completeness of Geocoding

Standard

Result

Of all persons with HIV infection diagnosed during <Year-2> (regardless of residence at diagnosis), at least (≥) 90% have a census tract for their residence at diagnosis, assessed December <Year-1>.

Upload the SAS output: [upload field] – will only appear for jurisdictions that do not send CDC census tract data


Of all persons entered in eHARS who were living with diagnosed HIV infection at the end of <Year-2> (regardless of jurisdiction of residence), at least (≥) 90% have a census tract for the residence at the end of evaluation year, assessed December <Year-1>.

Upload the SAS output: [upload field] – will only appear for jurisdictions that do not send CDC census tract data



Completeness of Antiretroviral Use History

Standard

Result

Of all persons with HIV infection diagnosed during <Year-2>, at least (≥) 70% have antiretroviral use history, assessed December <Year-1>.




For all unmet outcome standards provide an explanation why the standard was not met and plans for meeting it in the future in the appropriate space below. (there will be a separate text box for each unmet standard that will only appear if there are unmet standards)


J. Cluster Detection and Response Outcome Standards


Outcome Standard


Result

  1. Of all clusters that meet CDC’s cluster report form criteria detected during the evaluation year, ≥90% had an initial cluster report form submitted to CDC by the submission deadline


Calculated as 1a/(1b+1c)*100

  1. Number of initial cluster report forms submitted to CDC by the submission deadline for clusters that first meet CDC’s cluster report form criteria detected during <Year-1>

Field populated by CDC

(CRF REDCap)


  1. Number of priority molecular clusters that meet CDC’s cluster report form criteria first detected during <Year-1> (include those detected through both national and local analysis)

Upload the SAS output: [upload field]

Field populated by HD


  1. Number of time-space clusters or other clusters of concern that first meet CDC's cluster report form criteria during <Year-1>

Field populated by HD


  1. Of clusters that meet CDC’s criteria for an annual or closeout cluster report form, ≥90% had an annual or closeout cluster report form submitted to CDC by the submission deadline


Calculated as 2a/2b*100

  1. Number of annual or closeout cluster report forms submitted to CDC by December <Year-1>

Field populated by CDC

(CRF REDCap)


  1. Number of clusters that meet CDC’s criteria for an annual or closeout cluster report form during <Year-1>

Field populated by CDC

(CRF REDCap)


  1. Of people with HIV in clusters for which a cluster report form was submitted during the evaluation year, ≥90% had cluster variables entered in eHARS


Calculated as 3a/3b*100

  1. Number of people with HIV in clusters residing in the jurisdiction reported on cluster report forms during <Year-1> with cluster ID populated in eHARS

Field populated by CDC (eHARS)


  1. Number of people with HIV in clusters residing in the jurisdiction based on the most recent cluster report form submitted for each cluster during <Year-1>

Field populated by CDC (CRF REDCap)


For all unmet outcome standards provide an explanation why the standard was not met and plans for meeting it in the future in the appropriate space below. (there will be a separate text box for each unmet standard that will only appear if there are unmet standards)


K. Data Reporting and Dissemination



Standard

Result

1. Last year that your program published and disseminated a comprehensive revision of your integrated HIV Epidemiologic Profile:

At least once during <Year-5> - <Year-1>


2. If your program did not do a comprehensive revision of your integrated Epidemiologic Profile in <Year-1>, did your program update the executive summary and core epidemiologic data including tables and figures? The annual update can be in the form of fact sheets, supplemental reports, slide sets, or other standardized reports used by the state.

Yes


3. Did your program publish and disseminate an annual HIV surveillance report in <Year-1>?

Yes


4. Did your program publish and disseminate analyses on health equity per CDC guidance in <Year-1>?

Yes


5. Did your program share summary information about clusters and CDR activities (for example, in an annual report or public dashboard) in <Year-1>?

Yes


6. In <Year-1>, did your program’s reports incorporate analyses that describe relevant syndemics?

Yes



For all unmet data reporting and dissemination standards provide an explanation why the standard was not met and plans for meeting it in the future. (will only appear if there are unmet standards)


For all met standards provide the URL for the report. (there will be a separate text box for each type of report)


7. Describe how your program has increased availability and accessibility of data displays such as data dashboards.


L. Security and Confidentiality


In <Year-1>:

Yes

No

N/A

  1. Did your program fully comply 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); hereafter referred to as the NCHHSTP guidelines?



  1. Did your program ensure all persons with access to HIV data (including IT personnel) complete an annual security and confidentiality training that is consistent with the NCHHSTP guidelines, sign a confidentiality statement, and store it in the personnel file?


  1. Did your program conduct the required annual review of your security and confidentiality policies and procedures to assess whether changes in legislation or regulations, technology, priorities, personnel, or other situations require updates in policies and procedures?


  1. Did your program make enhancements or updates to security and confidentiality policies and procedures, as needed? (If none were needed, select N/A)

  1. Did your program apply the NCHHSTP guidelines to all sub-contractors and sub-recipients funded through PS18-1802 that have access to or maintain confidential HIV data?


  1. Did your program implement secure procedures for data sharing, including Data to Care (D2C) activities, within the context of existing laws, including within your public health program and with external partners (such as sub-recipients)?


  1. Did your program implement practices that support secure sharing and use of HIV data across necessary programs within the health department for collaboration with the Medical Monitoring Project (MMP) (if applicable)?

  1. Did your program immediately investigate all data security breaches that did not involve the release of personally identifiable information (PII)? (If there were no breaches, select N/A) If N/A is selected, a and b will not appear.

  1. Did your program report each non-PII breach to the ORP?

  1. Did your program take steps to ensure immediate investigation of all breaches of data security protocol, document investigation findings and identify and implement corrective actions?

  1. Did your program immediately investigate all breaches occur that resulted in the release of PII to unauthorized persons? (If there were no breaches, select N/A) If N/A is selected, a and b will not appear.

  1. Did your program report each PII breach to the ORP, CDC, and (if warranted) to law enforcement agencies?

  1. Did your program implement corrective actions for each breach to avoid similar incidents in the future?


For all ‘No’ responses above, please describe why your program was non-compliant and what corrective actions have been/will be implemented to ensure it will not occur in the future. (will only appear if No is selected for any of the S&C questions)





13


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitlePlease report on your progress towards meeting HIV Surveillance Process and Outcome Standards listed below
AuthorR. Luke Shouse
File Modified0000-00-00
File Created2024-09-05

© 2024 OMB.report | Privacy Policy