Performance Work Statement (ELR-RFI).pdf

ELR for COVID-19

PERFORMANCE WORK STATEMENT (PWS)

Indian Health Service Implementation of CARES Act Section 18115 - Electronic Lab Reporting (ELR) Requirements for COVID-19

General Information

1.0 Overview: The 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 35 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.

1.1 General: 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.

The Government shall not exercise any supervision or control over the contract service provider(s) performing the services herein. Such contract service provider(s) shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

1.2 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the services herein as defined in this Performance Work Statement except for those items specified as government furnished property. The contractor shall perform to the standards in this contract.

The services to be provided include the work necessary to onboard IHS via a single 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 and routed to CDC 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.

FOR OFFICIAL USE ONLY

ELR for COVID-19

Based on the the CARES Act citation, the platform shall provide an acceptable option for single intake point to reach all the State jurisdictions in which IHS operates. The platform shall have 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. The reduced level of effort will facilitate the effort to achieve the reporting guidance contained in the HHS memo.

1.3 Background: On March 13, 2020 the COVID-19 pandemic was declared an emergency by the President of the United States. Subsequent to this declaration, HHS issued a memo entitled "COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115" dated June 4, 2020 that sets a deadline of 1 August, 2020 for all laboratories conducting SARS-CoV-2 to report testing activity to State or local public health departments within 24 hours of the results being known. Given the testing effort underway in the IHS there is a compelling urgency to obtain a service that automates COVID-19 laboratory testing activity reporting to the public health agencies. Because IHS has facilities located in more than 30 states, this platform is the most cost and deployment efficient approach for the government.

1.4 Objectives: The objectives of this PWS are to provide for a services that allows submission of laboratory testing data to state and local public health departments through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platform) where such data will then be routed to the appropriate state and local authorities and routed to CDC after removal of elements to achieve de-identification according to applicable rules and regulations. The primary objectives of this PWS are to provide services to support 6 tasks:

1. Provide a single intake portal whereby ELR COVID-19 transmissions can be received from the various IHS facilities conducting COVID-19 testing. The transport protocol is to be sFTP based.

2. Assistance with the onboarding process required to setup the message feed and maintenance thereof.

3. Route said transmissions in a timely manner to the appropriate State/Local department of health systems based on a jurisdictional indicator and/or on the demographic information contained in the message.

4. Provide reporting to show that mandated reporting is occurring in a timely manner sufficient to satisfy audit requirements.

5. Provide timely notifications of system outages and information on recovery procedures.

6. Conduct the processing in a manner that meets regulatory requirements and industry best practices for security and privacy considerations.

1.7 General Information

1. Quality Control The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which work is assured to comply with the requirements of the contract. The contractor’s proposal is an evaluation factor and three (3) copies of a comprehensive written Quality Control Plan (QCP) shall be submitted to the Contracting Officer and COR within 5 working days of the start date of the contract and subsequently within five days of a change to the plan thereafter. After acceptance of the QCP the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to the contractor’s QC system. The approach to Quality Control should map to the contractor’s selected development methodology.

However it must also address support for QASP reporting requirements.

2. Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines the performance standards, how the performance standards will be applied, and the frequency of surveillance. The government may use contractors, acting as agents of the government, to carry out QASP monitoring and reporting requirements.

3. The contractor is required to perform services on the federal holidays listed below.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

1.5 Scope: The scope of work will include performing services that support the objectives and will include a mechanism whereby IHS can obtain support to setup and maintain the activity as needed.

1.6 Period of Performance: The Period of Performance shall be one (1) base year period and three

(3) option year periods.

4. Hours of Operation: The contractor is responsible for conducting business, between the hours of 0900 -1800 (Eastern Time) Monday thru Friday except when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

The Contractor must provide 24/7/365 after-hours coverage for emergency situations.

5. Place of Performance: All contract personnel may perform work at duty stations determined by the Contractor.

6. Type of Contract: The government will award a Firm Fixed Price (FFP) contract.

7. Security Requirements:

The contractor and sub-contractor personnel shall be subject all Federal laws and regulations pertaining to the securing of protected information that may be included in the course of conducting these operations. Contractor personnel may be exposed to sensitive and unclassified information systems and documents.

To perform the work specified herein, contractor and sub-contractor personnel are not expected to have physical access to an HHS controlled facility nor logical access to an HHS controlled information system.

The contractor and sub-contractor personnel are expected to have access to protected health information. Said access will be controlled under various agreements such as the Business Associates Agreement that will be associated with the contract.

1.8 Special Qualifications: The Contractor shall have proficiency and knowledge necessary to intake, process, and forward ELR messages to the appropriate jurisdictions in a manner that meets the regulatory and industry best practices standards regarding protected health information or protected personal information. .

The contractor will have existing relationships with the State Health Departments in the jurisdictions in which IHS operates sufficient to route messages in a timely manner to meet COVID-19 reporting mandates.

1.9 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.10 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance;

maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.11 Key Personnel: The contractor shall propose Key Personnel whose technical skills and experience are essential to the accomplishment of the task. The Offeror’s Technical Proposal shall include the resume of any individuals designated as Key Personnel. No substitutions shall be made of accepted Key Personnel except for sudden illness or death, or termination of employment. Contractor requests for substitution of Key Personnel shall be submitted in writing to the COR and the Contracting Officer at least twenty-five (25) calendar days in advance of the effective date, whenever possible. Such requests shall include a detailed explanation of the circumstances necessitating the proposed substitution, a resume for the proposed substitute, and any other information requested by the Contracting Officer necessary to approve or disapprove the proposed substitution. An interview may also be requested.

The COR and the Contracting Officer will evaluate substitution requests and promptly notify the Contractor of approval or disapproval in writing.

The Government reserves the right to evaluate the technical skill and competence of any Contractor staff members, to require removal and replacement, upon written notice, of any individuals whose qualifications or performance are judged deficient at any time.

The following personnel are considered Key Personnel by the government:

• Project Manager (Project Manager)

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between, 9:00 a.m. to 5:30p.m Eastern Time, Monday thru Friday except when the government facility is closed for administrative reasons.

1.12 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, using government email, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors that render the contractors opinion or position as a consultant are suitably marked as contractor products or that contractor participation is appropriately disclosed. However, documents being prepared by the Contractor on behalf of the Government, especially for external stakeholder consumption, shall not be branded by the Contractor. Contract personnel shall be required to obtain badges issued by the government as outline in section 1.7.7 Security Requirements. When performing services on site, contract staff shall wear badges as required.

1.13 Contractor Travel Contractor will not be required to travel during the performance of the PWS.

1.14 Other Direct Costs ODCs are not expected on this PWS.

1.15 Data Rights The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights. All relevant documents, images, source code, and other relevant files must be provided to the government in non-compiled, non-protected, editable formats. Works produced under this contract shall not be branded with the contractor’s logos or trademarks when the works are intended for audiences or users outside of the IHS Office of Information Technology.

1.16 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may effect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.17 PHASE IN /PHASE OUT PERIOD To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the (30) day, phase in/ phase out periods. During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

1.17.1 Phase-In Period

The Contractor shall complete all transition activities within 30 days of contract award. The Contractor shall provide a contract schedule with critical activities and milestones.

1.17.2 Phase-Out Period

The Contractor shall provide a detailed plan for transition activities 60 day prior to the end of the contract period of performance or by notification of the COR regardless of precipitating reasons. The plan shall include procedures for minimizing impact on performance in compliance with standards in the contract. The plan shall also describe in detail how responsibility and accountability will be relinquished for any Government-furnished items/property.

During the "phase-out" period the Contractor will remain responsible for the services required in this contract. The Contractor shall not defer any needed tasks for the purpose of avoiding responsibility to the successor contractor.

The Contractor shall coordinate phase out activities with the incoming Contractor to effect a smooth and orderly transition at the end of the contract period. The Contractor shall remove all Contractor-owned equipment, tools, parts and belongings from the Government-furnished facilities by midnight on the last day of the contract. The Contractor shall provide on-the-job familiarization for the incoming Contractor, as required.