Attachment 1 -- Electronic Lab Reporting_Requirements Doc - for NOI sole source posting_10.27.25.pdf

Attachment 1

Requirements Document

IHS Resource Patient Management System/ Association of Public Health Labs (APHL) -

Electronic Laboratory Reporting

Indian Health Service

BACKGROUND

The Indian Health Service (IHS), an agency within the Department of Health and Human

Services (HHS), is responsible for providing federal health services to American Indians and

Alaska Natives (AI/AN). The IHS is the principal federal health care provider and health advocate for Indian people, and its goal is to raise their health status to the highest possible level.

The IHS provides a comprehensive health service delivery system for approximately 2.56 million AI/AN people who belong to 574 federally recognized tribes in 37 states.

This request supports the IHS Resource Patient Management System Electronic Health Record

(RPMS EHR) Electronic Lab Reporting for transmitting reportable laboratory testing to public health agencies. ELR is the transmission of digital laboratory reports from laboratories to healthcare and public health partners. It automates the reporting process by translating information into an electronic message that can be automatically sent and processed, it is important as it provides an essential tool in the response to outbreaks.

The Indian Health Service (IHS) is the principal Federal healthcare provider and health advocate for

American Indian people providing a comprehensive health services delivery system for American

Indians and Alaska Natives. The IHS Office of Information Technology (OIT) is required to support and maintain the availability, integrity, and confidentiality of the Health IT systems that support the

IHS mission. This is a non-personal services contract to support the Electronic Laboratory

Reporting (ELR) of the reportable laboratory testing data of COVID-19 and the Sexually

Transmitted Infection (STI), HIV & Viral Hepatitis to a centralized intake service for further distribution to the appropriate State Department of Health and Federal Agencies concerned with aggregating reportable laboratory test results for epidemiological processing. IHS is obligated to report this information, this approach provides a streamlined and cost-effective solution for the government to meet the requirement.

Based on the Coronavirus Aid, Relief, and Economic Security (CARES) Act citation, the APHL

Informatics Messaging Services (AIMS) platform has been the only service identified by the

Department of HHS (DHHS) that provides an acceptable option for a single intake point to reach all the State jurisdictions in which IHS operates. The APHL AIMS platform has existing connections to all 50 state public health departments, the CDC, and several local public health organizations. Having a single point of intake reduces the administration, configuration, and maintenance level of effort required to automate the required COVID-19 test reporting and the

Sexually Transmitted Infection (STI) laboratory data to State Department of Health and Federal

Agencies concerned with aggregating reportable laboratory test results for epidemiological processing.

As early as 2005, the Centers for Disease Control and Prevention (CDC), in partnership with the

Association of Public Health Laboratories (APHL), began paving the way for what is now the

COVID-19 Electronic Laboratory Reporting (CELR) program. In 2009, APHL created a secure, cloud-based platform to help state health departments, state laboratories, regional commercial laboratories, and federal agencies report their data. State health departments have increasingly used this platform, supported by ongoing financial and technical support from the CDC, to increase the reportable disease results shared with the CDC.

In addition, IHS Division of Information Technology has an existing interface with the APHL for the delivery of patient results for COVID-19 and the STI tests, using the Certified Electronic Health Record technology

Consequences (to mission) of not fulfilling the request currently:

IHS healthcare facilities will not have a unidirectional HL7 interface as the single intake point and dissemination to the State Public Health Agencies for COVID-19 and STI test results.

Manual entry will be the alternative, which is prone to clerical errors, is inefficient and not at all timely.

Consequences to IHS are the impact of not having the AIMS platform which has been the only service identified by DHHS that provides an acceptable option for a single intake point to reach all the State jurisdictions in which IHS operates. The APHL Informatics Messaging Services (AIMS) platform has existing connections to all 50 state public health departments, the CDC, and several local public health organizations. Having a single point of intake reduces the administration, configuration, and maintenance level of effort required to automate the required COVID-19 test reporting and the Sexually Transmitted

Infection (STI) laboratory data to State Department of Health and Federal Agencies concerned with aggregating reportable laboratory test results for epidemiological processing.

Mission-related (i.e. patient care, direct or indirect) services are impacted if not done:

Indian Health Service (IHS) is the principal Federal health care provider and health advocate for

American Indian people which provides a comprehensive health services delivery system for

American Indians and Alaska Natives. The range of services includes traditional inpatient, ambulatory care, preventive care, and population health which is delivered through a network of hospitals and clinics distributed through 30+ jurisdictions in 50 states. The IHS Office of

Information Technology (OIT) is required to support and maintain the availability, integrity, and confidentiality of the Health IT systems that support the IHS mission.

This procurement is required in order to not impact direct patient care services and subsequently, required reporting to State Public Health Agencies.

This is a non-personal services contract to support the routing of COVID-19 electronic lab reports to a centralized intake service for further distribution to the appropriate State Department of Health and Federal Agencies concerned with aggregating COVID-19 testing efforts and results for epidemiological processing.

The need for this service is predicated upon a mandate delineated in the HHS memo "COVID-19

Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115" dated June 4, 2020.

The memo requires all laboratories conducting COVID-19 testing to report their activities via one of three methods. Of the three methods described, only the centralized services model provides a way that allows the possibility of meeting the August 1, 2020 deadline and begin submission for IHS as a whole (all states) utilizing an automated process. This single connection is the most cost effective for the government in that a single interface to this repository provides information to all states as opposed to 28+ individual interfaces to each state.

Contractor Justification:

The contract includes RPMS Electronic Health Record (EHR) and RPMS software development services that are not readily available in the government. Therefore, these services will continue to be outsourced.

Requirements:

The contractor or vendor shall

The services to be provided include the work necessary to onboard IHS via a single Secure Shell

(SSH) File Transfer Protocol (sFTP) endpoint to a centralized platform that accepts HL7 formatted messages that contain data which will then be routed to the appropriate state and local authorities after removal of elements to achieve de-identification according to applicable rules and regulations.

There are currently more than 30 jurisdictions that IHS operates in, 50+ states.

Period of performance:

The period of performance is one (1) twelve (12)-month base period plus four (4) twelve (12)-month option periods. Base to begin January 01, 2026.

DELIVERY

Electronic Delivery to:

US Department of Health and Human Services

Indian Health Service