0920-0573 NHSS Standards Evaluation Report Form

Form Approved OMB No. 0920-0573

Exp. Date: XX/XX/XXXX

2019 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 2018, did your surveillance program do an assessment to identify all laboratories (in state and out of state) that conducted HIV-related testing for providers and facilities in your jurisdiction using a method such as a lab survey, Centers for Medicare and Medicaid Services (CMS) search, or state laboratory licensing office search? This must include more than just counting the number of labs submitting HIV-related test results to the health department.

☐ Yes

• Number of laboratories? Click here to enter text.

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

☐ No

• Based on eHARS data, what is the number of HIV-testing laboratories that reported at least one HIV test result to your program during 2018?

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 in 2018?

☐ Yes

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

☐ No

3. Of the laboratory data reported to your program during 2018, are you aware of any issues that prevented your program from receiving all positive/reactive HIV detection test results, all CD4 results (<200 and ≥200), or all viral load results (detectable and undetectable) and resulted in missing lab data in your December 2018 data transfer? For example:

   1. Laboratory XYZ usually sends 500 viral load results each month, however, during August, undetectable viral load results were not received from Laboratory XYZ and the problem was not resolved by December 2018; or

   2. Laboratory XYZ was transmitting all viral load result but the HL7 ELR reader/transmitter in the health department did not send the test results to the HIV program

☐ No

• In 2018, 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

☐Yes

Approximately what percentage of all test results in a given year is typically reported by this laboratory or laboratories?	Click here to enter text.
Approximately what percentage of the test results expected from this laboratory or laboratories in 2018 was not received?	Click here to enter text.
Please describe the expected test results that were not received from this laboratory or laboratories: Click here to enter text.

4. By December 2018, 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 2016-2018?

Year reports were received	CD4 results				Viral load results
	Yes	No	If “no”, what % of results received have been transferred to CDC?	Describe type of CD4 results received (e.g., All values, <500, <200)	Yes	No	If “no”, what % of results received have been transferred to CDC?	Describe type of viral load results received (e.g., Any result, detectable)
2016	☐	☐	%	Click here to enter text.	☐	☐	%	Click here to enter text.
2017	☐	☐	%	Click here to enter text.	☐	☐	%	Click here to enter text.
2018*	☐	☐	%	Click here to enter text.	☐	☐	%	Click here to enter text.

*At minimum, reports received from January 2018 through September 2018

C. Pediatric/Perinatal

Birth Ascertainment	In 2018, did you link women with diagnosed HIV infection reported to the surveillance system to state/local birth certificate data for all 2017 births to identify all perinatally exposed infants and infants with HIV infection not reported to surveillance, and enter the results into eHARS?	☐ Yes	☐ No
Number of perinatally HIV exposed infants for birth year 2017	Number of perinatally HIV exposed infants born in 2017 that were identified through the match to birth certificates. *This should include exposed infants previously known to the HIV surveillance program.	Click or tap here to enter text.

D. Cluster Detection and Response

	Yes	No
In 2018, did your program develop a written plan for establishing and maintaining capacity for cluster and outbreak detection and response and submit the plan to CDC?	☐	☐
In 2018, did your program analyze molecular data using CDC-recommended approaches at least monthly to identify HIV transmission clusters and outbreaks?	☐	☐
In 2018, 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 2018.

2. Your plan to ensure your program meets this standard in 2019.

Outcome Standards for Surveillance

NOTE: All areas MUST run the CDC-supplied SAS program against the December 2018 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.

E. 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

Risk factor ascertainment tables: ☐ Yes ☐ No

Completeness of laboratory tables: ☐ Yes ☐ No

Data quality tables: ☐ Yes ☐ No

Death ascertainment tables: ☐ 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 2017 by the end of December 2018?	%
	Did your surveillance program ascertain at least (≥) 90% of the expected number of persons newly diagnosed with HIV infection in 2017 within 6 months of date of diagnosis, assessed at the end of December 2018?	%
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, 2017 by the end of December 2018?	%
Routine Interstate Duplicate Review (RIDR)	Were at least (≥) 98% of the pairs on your RIDR list received in January 2018 resolved by June 30, 2018? ☐ N/A Done by state	%
	Were at least (≥) 98% of the pairs on your RIDR list received in July 2018 resolved by December 31, 2018? ☐ N/A Done by state	%
Risk Factor Ascertainment	Did at least (≥) 80% of HIV cases newly reported to your surveillance program in 2017 have sufficient risk factor information to be classified into a known HIV transmission category by the end of December 2018?	%
Completeness of Initial CD4	Did at least (≥) 85% of adults and adolescents newly diagnosed with HIV infection in 2017 have a CD4 count or percent based on a specimen collected within one month following their initial diagnosis, by the end of December 2018?	%
Completeness of Initial Viral Load	Did at least (≥) 85% of adults and adolescents newly diagnosed with HIV infection in 2017 have a viral load based on a specimen collected within one month following their initial diagnosis by the end of December 2018?	%
Data Quality	In 2017, 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 2018?	%
Timeliness of Laboratory Reporting*	Were at least (≥) 85% of all labs with a specimen collection date in 2017 loaded in the surveillance system within 60 days of the specimen collection date, assessed at the end of December 2018?	%
Nucleotide Sequence*	Did at least (≥) 60% of cases diagnosed in 2017 have an analyzable nucleotide sequence by the end of December 2018?	%
Antiretroviral History*	Did at least (≥) 70% of cases diagnosed in 2017 have prior antiretroviral use history by the end of December 2018?	%
Cause of Death*	Did at least (≥) 85% of the deaths that occurred in 2016 have an underlying cause of death by the end of December 2018 (24 months after the death year)?	%
Previous Negative HIV Test*	Did at least (≥) 70% of cases diagnosed in 2017 have a known value for previous negative HIV test by the end of December 2018?	%
	Did at least (≥) 50% of cases diagnosed in 2017 with a previous negative test have a valid date of documented negative test result, assessed by the end of December 2018?	%

*Indicates a new outcome measure on the 2019 SER that should be interpreted as a baseline result since it was not required for all jurisdictions during the 2017 data collection year. It is expected that these measures will be met on the 2020 SER.

F. Data Reporting and Dissemination

In 2018 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?	☐	☐

G. Security and Confidentiality

		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?	☐	☐