Tracked-changes version of the 2021 SER to facilitate review of changes

Form Approved OMB No. 0920-0573

Exp. Date: 11/30/2022

2021 Standards Evaluation Report (SER)

Process and Outcome Standards for Surveillance

Process Standards

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).

Ascertain dates of deaths		Linked with deaths occurring through
1	Vital statistics file loaded for deaths OR
	NDI-Plus early release file loaded for deaths	☐Prohibited
2	SSDMF loaded for deaths
Ascertain causes of deaths		Linked with deaths occurring through
3	NDI Plus final file with cause-of-death information loaded for deaths	☐Prohibited
4	Vital statistics final file with cause-of-death information loaded for deaths
Search for potentially unreported HIV cases		Linked with deaths occurring through
5	Searched all vital records deaths mentioning HIV infection and loaded previously unreported cases

If you did not load all of the required files in 1-5 above in accordance with the process standards outlined in the Death Ascertainment Technical Guidance for HIV Surveillance Programs file, please discuss:

1. Why you did not load each file in accordance with the process standards.

2. Your plan to ensure your program loads each file in the next evaluation period in accordance with the process standards.

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).

B. Laboratory

1. In 2020, did your surveillance program develop and/or update the list of all laboratories (in state and out of state) that conducted HIV-related testing for persons who reside in your jurisdiction using a method such as Centers for Medicare and Medicaid Services (CMS) search, or evaluation of your electronic laboratory report (ELR) program baseline spreadsheet?

☐ Yes

• Did you identify new laboratories that conduct HIV testing for persons who reside in your jurisdiction?

☐ Yes

☐ No

• What is the total number of laboratories that report HIV-related test results for persons who reside in your jurisdiction? Click here to enter text.

  • Please describe how your program obtained this number. Click here to enter text.

☐ No

3. In 2020, did your surveillance program conduct an assessment on laboratories that conducted HIV-related testing for persons who reside in your jurisdiction? This assessment is to maintain documentation, such astypes of tests performed and LOINC usage, by all laboratories that report to your jurisdiction.

☐ Yes

☐ No

4. 3. Are you aware of any laboratory reporting lapses of HIV-related test results for persons who reside within your jurisdiction that resulted in missing lab data in your December 2020 data transfer? Please include lapses attributed to either the lab not reporting test results or because the HL7 reader/transmitter in the health department did not send the results to HIV surveillance

☐ Yes

• Approximately what percentage of your total jurisdiction’s lab volume is missing because of this? Click here to enter text.

• Approximately what percentage of all CD4 results (<200 and ≥200), or all viral load results (detectable and undetectable) are missing because of this? Click here to enter text.

☐ No

• In 2020, 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

5. 4. By December 2020, 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 2017-2019?

Year reports were received	CD4 (< 200 and ≥ 200)				Viral load tests (detectable and undetectable)
	Yes	No		Describe type of CD4 results received	Yes	No		Describe type of viral load results received
2018	☐	☐		Click here to enter text.	☐	☐		Click here to enter text.
2019	☐	☐		Click here to enter text.	☐	☐		Click here to enter text.
2020*	☐	☐		Click here to enter text.	☐	☐		Click here to enter text.

*At a minimum, reports received from January 2020 through September 2020

C. Pediatric/Perinatal

Birth Ascertainment	1A. In 2020, did you link women with diagnosed HIV infection reported to the surveillance system to state/local birth certificate data for all 2019 births to identify all perinatally exposed infants with a residence of birth in your jurisdiction and infants with HIV infection not  [reported to surveillance, and enter the results into eHARS? ☐ Yes ☐ No 1B. If no to 1A, please describe why you did not link with all state/local birth certificate data. [Free text] 1C. If yes to 1A, did you enter all information identified from the linkage to state/local birth certificate data into eHARS before your final December 2020 data transfer to CDC? ☐ Yes ☐ No ID. If no to 1C, please describe why you did not enter all information identified from the link to state/local birth certificate data into eHARS. [Free text]
Number of perinatally HIV exposed infants for birth year 2019	Number of perinatally HIV exposed infants born in 2019 that were identified through the match to birth certificates. *This should include exposed infants previously known to the HIV surveillance program. Does this match with the number of perinatally exposed infants reported to CDC through your final December 2020 data transfer? ☐ Yes ☐ No 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).

D. Geocoding and Data Linkage

Submission of Geocoded Data

In 2020, did you submit your geocoded data to CDC, per CDC guidance and the joint MOU?

☐ Yes

☐ No

E. Cluster Detection and Response

	Yes	No
In 2020 plan for establishing and maintaining capacity for cluster and outbreak detection and response according to CDC guidance?did your program develop and submit a written	☐	☐
In 2020, did your program analyze molecular data using CDC-recommended approaches at least monthly to identify HIV transmission clusters and outbreaks?	☐	☐
In 2020, did your program conduct time-space analysis using CDC-recommended approaches at least monthly to identify HIV transmission clusters and outbreaks?	☐	☐

If you did not meet the standards in 1, 2, or 3 above, please discuss each unmet standard:

1. Why you did not meet the minimum standards for cluster detection and response in 2020.

2. Your plan to ensure your program meets this standard in 2021.

Outcome Standards for Surveillance

NOTE: All areas MUST run the CDC-supplied SAS program against the December 2020 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.

F. Submission of Required SAS Outcome Tables

Please confirm that you have attached the following SAS outcome tables to your SER submission. I have attached:

Case ascertainment tables: ☐ Yes ☐ No

Intrastate case duplication rate tables: ☐ Yes ☐ No

Routine Interstate Duplicate Review tables: ☐ Yes ☐ No

Cumulative Interstate Duplicate Review table: ☐ Yes ☐ No

Risk factor ascertainment tables: ☐ Yes ☐ No

Completeness of laboratory tables: ☐ Yes ☐ No

Data quality tables: ☐ Yes ☐ No

Death ascertainment tables: ☐ Yes ☐ No

Geocoding: ☐ Yes ☐ No

Viral suppression for cluster members ☐ Yes ☐ No

Measure	Standard	Result
Completeness and Timeliness of Case Ascertainment	Did your surveillance program ascertain at least (≥) 95% of the expected number of persons newly diagnosed with HIV infection in 2019 by the end of December 2020?	%
	Did your surveillance program ascertain at least (≥) 90% of the expected number of persons newly diagnosed with HIV infection in 2019 within 6 months of date of diagnosis, assessed at the end of December 2020?	%
Intrastate Duplicate Review	Were there less than or equal to (≤) 1% duplicate case reports among all (cumulative) cases reported to your surveillance program through December 31, 2019 by the end of December 2020?	%
Routine Interstate Duplicate Review (RIDR)	Were at least (≥) 98% of the pairs on your RIDR list received in January 2020 resolved by June 30, 2020? ☐ N/A Done by state	%
	Were at least (≥) 98% of the pairs on your RIDR list received in July 2020 resolved by December 31, 2020? ☐ N/A Done by state	%
Cumulative Interstate Duplicate Review (CIDR)	Were at least (≥) 60% of the pairs on your CIDR list received in 2019 resolved by December 31, 2020? ☐ N/A Done by state	%
Risk Factor Ascertainment	Did at least (≥) 80% of HIV cases newly reported to your surveillance program in 2019 have sufficient risk factor information to be classified into a known HIV transmission category by the end of December 2020?	%
Completeness of Initial CD4	Did at least (≥) 85% of adults and adolescents newly diagnosed with HIV infection in 2019 have a CD4 count or percent based on a specimen collected within one month following their initial diagnosis, by the end of December 2020?	%
Completeness of Initial Viral Load	Did at least (≥) 85% of adults and adolescents newly diagnosed with HIV infection in 2019 have a viral load based on a specimen collected within one month following their initial diagnosis by the end of December 2020?	%
Timeliness of Laboratory Reporting	Were at least (≥) 85% of all labs for new diagnoses with a specimen collection date in 2019, loaded in the surveillance system within 60 days of the specimen collection date, assessed at the end of December 2020?	%
Nucleotide Sequence	Did at least (≥) 60% of cases diagnosed in 2019 have an analyzable nucleotide sequence by the end of December 2020?	%
Antiretroviral History	Did at least (≥) 70% of cases diagnosed in 2019 have prior antiretroviral use history by the end of December 2020?	%
Data Quality	In 2019, did 97% of case records that meet the surveillance case definition for HIV infection have no required fields missing and pass all selected data edits by the end of December 2020?	%
Cause of Death	Did at least (≥) 85% of the deaths that occurred in 2018 have an underlying cause of death by the end of December 2020 (24 months after the death year)?	%
Geocoding	Were at least (≥) 90% of HIV cases diagnosed in 2019 geocoded to the census tract level by the end of December 2020?	%
Previous Negative HIV Test*	Did at least (≥) 70% of cases diagnosed in 2019 have a known value for previous negative HIV test by the end of December 2020?	%
	Did at least (≥) 50% of cases diagnosed in 2019 with a previous negative test have a valid date of documented negative test result, assessed by the end of December 2020?	%
Viral suppression for cluster members*	Did at least (≥) 60% of HIV-positive persons who were not virally suppressed at identification as part of a cluster, achieve viral suppression within 6 months (for persons identified as part of a transmission cluster in 2019)?	%
Perinatal HIV Exposure Reporting	Did ≥ 85% of perinatally exposed infants born in 2018 have HIV infection status determined by 18 months of age?	%

*If you did not meet the Previous Negative HIV Test or Viral Suppression for Cluster Members standard above, please discuss:

1. Why you did not meet the minimum standards in 2020.

2. Your plan to ensure your program meets the standards in 2021.

G. Submission of Required Outcome Standards without SAS Tables

Note: This section is optional since cluster detection activities were not required for all of 2019.

Measure	Standard	Result
		%	Numerator	Denominator
Testing/re-testing of HIV-negatives and persons with unknown HIV status	For partners of transmission cluster members who were not known to be HIV positive at the time of cluster identification, what percentage were tested or re-tested within 6 months of identification as part of the risk network (for persons identified as part of a risk network in 2019)?
	Persons with unknown HIV status:	%	n	n
	Persons with negative HIV status:	%	n	n
	Total:	%	n	n
PrEP Referral	For HIV-negative partners of transmission clusters not on PrEP, what percentage were referred for PrEP within 6 months of identification as part of the risk network (for persons identified as part of a risk network in 2019)?	%	n	n

For the two Testing/re-testing and PrEP Referral standards above, please briefly discuss what you plan to do in the coming yearto improve testing/re-testing and PrEP referral outcomes for persons in clusters and risk networks. .

H. Data Reporting and Dissemination

In 2020 did you develop and disseminate:	Yes	No
A comprehensive revision of your integrated HIV Epidemiologic Profile?	☐	☐
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)?	☐	☐
An annual HIV surveillance report?	☐	☐

I. Security and Confidentiality

In 2020:		Yes	No
Security and Confidentiality	Did your program provide a statement signed by the Overall Responsible Party (ORP) certifying that 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)?	☐	☐
	Did 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?	☐	☐
	Did your program conduct the required annual review of your written 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?	☐	☐
	Did your program complete (or participate 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)?	☐	☐
	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?	☐	☐
	Did your program implement secure procedures for data sharing, including D2C activities, within the context of existing laws, including within your public health program and with external partners as sub-recipients?	☐	☐
	Did your program implement practices that support secure sharing and use of HIV data across necessary programs within the health department, including MMP (if applicable)?	☐	☐
	Did any data security breach occur, whether it was of personally identifiable information (PII) or a policy breach? (If yes, please answer a and b below)	☐	☐
	Did your program ensure documentation and reporting of the data security breach with immediate investigation (regardless whether there was the release of personal information)?	☐	☐
	Did your program implement corrective actions to avoid breaches of data security protocol?	☐	☐
	Did any breach occur that resulted in the release of PII to unauthorized persons? (If yes, please answer a and b below)	☐	☐
	Did your program ensure that the breach that resulted in the release of PII to unauthorized persons was reported to the ORP, to CDC, and, if warranted to law enforcement agencies?	☐	☐
	Did your program implement corrective actions to avoid breaches that result in the release of PII to unauthorized persons?	☐	☐

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