This is a Small Business Sources Sought notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of qualified small business sources to perform a potential requirement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The primary NAICS code for this acquisition is 621511- Medical Laboratories, with a size standard of $35M, with additional capability needs under NAICS codes 325413- In-Vitro Diagnostic Substance Manufacturing, and 454110- Electronic Shopping and Mail-Order Houses. Background: The Centers for Disease Control and Prevention (CDC) is an operational Division under the U.S. Department of Health and Human Resources (HHS) charged with promoting the good health and well-being of Americans of all ages by preventing infections, injuries, and illnesses from ever occurring. More specifically, CDC’s mission is to promote health and improve the quality of life by preventing and controlling disease, injury, and disability. The CDC is the Nation’s lead prevention agency for these adverse health events. With an annual budget of more than $12 billion, including the Vaccines for Children Program, and more than 13,000 staff, CDC supports communities throughout the U.S. and protects Americans by working in more than 60 countries around the world. Almost 85% of CDC’s domestic funding is provided directly to state and local entities to detect and control disease, prevent the leading causes of death and pre-pare for health threats. CDC protects the nation and the world by detecting and responding to new and emerging health threats, preventing injuries, illnesses, and premature deaths by discovering new ways to protect and improve the public’s health by leveraging science and advanced technology. CDC’s headquarters is located in Atlanta, Georgia and organizationally divided into approximately twelve major, organizational business units or “Centers”. These Centers are designed, in large part, to address an assemblage of related public health issues or disease threats. The National Centers for HIV, Hepatitis, Sexually Transmitted Diseases and Tuberculosis Prevention (NCHHSTP) is one of the largest Centers within the CDC. NCHHSTP’s mission is to maximize public health and safety nationally and internationally through the elimination, prevention, and control of disease, disability, and death caused by human immuno-deficiency virus (HIV) infections, non-HIV retroviruses, viral hepatitis, sexually transmitted infections (STIs), and tuberculosis. NCHHSTP is sub-divided organizationally, and to a large extent operationally, into five Divisions that operate under the auspices of the NCHHSTP Office of the Director. Division activities are primarily focused on supporting specific, public health initiatives unique to the mission assigned to each. The Office of the Director provides leadership, coordination and administrative support for its five subordinate Divisions. The organizational structure of NCHHSTP divided into the six major entities listed immediately below: 1. The Office of the Director (OD) – provides senior leadership, policy & planning, financial oversight, administrative services supporting all Programs/Divisions 2. Division of HIV/AIDS Prevention (DHAP) 3. Division of Sexually Transmitted Diseases and Prevention (DSTD) 4. Division of Tuberculosis Prevention and Elimination (DTBE) 5. Division of Viral Hepatitis (DVH) 6. Division of Adolescent and School Health (DASH) A strategic priority of NCHHSTP is to support collaboration between programs across its Divisions and integration of screening services for populations at high-risk for multiple diseases. NCHHSTP works with programs to discover new and innovative ways to collaborate and use resources wisely and efficiently. To that end, services provided under this SOW are needed for NCHHSTP to integrate testing services for HIV, STIs and viral hepatitis and to provide a coordinated effort to address gaps in accessibility of testing services in the US. NCHHSTP Mission: The mission of NCHHSTP is to promote health and advance the quality of life by preventing and controlling HIV, viral hepatitis, STIs, and tuberculosis. This requires working with a variety of State and local government agencies, community non-profit organizations and private or commercial public health partners (domestic and international). This task order is intended to assist NCHHSTP in achieving its mission by administering an integrated system for shipping self-administered test kits, conducting laboratory testing on returned specimens and providing test results and referrals to persons at-risk of HIV, STI and viral hepatitis infections. Purpose and Objectives: The purpose of this requirement is to facilitate public access to HIV, STI and viral hepatitis testing to accelerate the identification of undiagnosed infections of these diseases and to facilitate pre-exposure prophylaxis (PrEP) initiation and monitoring to communities in the US, including the District of Columbia, Puerto Rico and the US Virgin Islands. The objective is to administer a system for the targeted mass distribution of free US Food and Drug Administration (FDA)-approved HIV rapid self-test kits and free HIV dried blood spots (DBS), STI, viral hepatitis and PrEP self-collection test kits in the US. Objectives also include: Developing, hosting, and administering a web-based ordering portal leveraging a cloud service provider or an existing system that will meet HHS and CDC security requirements, HIPAA requirements and Section 508 compliance. The web-based portal shall be able to manage and track orders, fulfillments, receipt of returned specimens, and notification of test results. The web-based portal shall also be able to link to CDC or HHS websites. Providing a service for test kit orders, shipping and fulfillment, including free return shipping of returned self-collected specimens. Providing laboratory services using Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) validated protocols. Providing services for returning test results and referrals to medical care and other services. Providing flexible services based on NCHHSTP’s needs, including quickly implementing optional tasks/services when exercised and providing surge support. Providing flexible services that are capable of meeting varying levels of ordering demand throughout the performance period from different types of customers (e.g. medical providers for PrEP test kits). High demand for HIV rapid self-test kits is anticipated around the period of CDC marketing campaigns around national testing days. Accommodating orders from CDC partners at the same prices for test kits and services delivered under this contract. A separate accounting system will be required for work ordered by partners. Abiding by state laws and regulations for shipment of test kits to individuals and for notifying state and local health departments of positive test results. Project Scope: The scope of this requirement is to provide a service to accept orders and ship free self-administered test kits for HIV, STIs, viral hepatitis and PrEP, receive and store returned self-collected specimens, conduct laboratory testing on returned specimens, and provide test results and referrals to medical care and other services. The scope of this contract includes both required and optional tasks. Required tasks include supporting a system for the shipping and fulfilment of FDA-approved HIV rapid self-tests, with highest demand anticipated around National HIV Testing Day marketing efforts. Optional tasks include shipping and fulfilment of self-collection kits for HIV DBS, STI, viral hepatitis and PrEP initiation/monitoring and subsequent laboratory testing and notification of test results. Optional tasks also include additional support for both required and optional tasks (i.e. increasing the number of test kits and related services). The government will exercise optional tasks and services based on public health need and demand. Overall, required and optional tasks include: 1) Information technology services to support a web-based ordering portal; 2) Procurement and storage of test kits and reagents (including additional support); 3) Shipping and fulfillment of test kits; 4) Laboratory-based testing on returned self-collected specimens; 5) Notification of test results and provision of referrals to individuals; and 6) Notification of positive test results to health departments as required under state reporting laws. Specific tasks in the SOW for the base period are listed below: Task 1. Planning and Progress Contract Kickoff Meeting: two day virtual or in-person meeting in Atlanta, GA Revised Project Management Work Plan Conference Calls or Webinars: weekly calls/webinars and drafting of minutes Task 2. Procurement and Storage of Test Kits and Reagents Procurement and Storage of Minimum Number of HIV Rapid Self-tests: procure a minimum of 60,000 HIV rapid self-tests for distribution in anticipation of orders during the National HIV Testing Day marketing period. HIV rapid self-tests shall be approved for use in the US by FDA and have a minimum of a 12-month shelf life. Storage shall be in accordance with the package insert and manufacturer’s temperature and other specifications. (Optional) Surge Support for Procurement and Storage of HIV Rapid Self-tests: provide surge support for (a) by purchasing and storing up to 200,000 additional HIV rapid self-tests in increments of 50,000 each. (Optional) Procurement and Storage of HIV DBS Test Kits and Reagents: procure a minimum of 10,000 HIV DBS self-collection kits for distribution and corresponding reagents, utilizing HIV Antigen/Antibody tests and appropriate HIV supplemental tests. Storage shall be in accordance with the package insert and manufacturer’s temperature and other specifications. (Optional) Procurement and Storage of STI Test Kits and Reagents: procure a minimum of 10,000 packaged STI self-collection kits (70% female chlamydia/gonorrhea kits with vaginal swab and 30% male 3-site kits) for distribution and corresponding reagents. Storage shall be in accordance with the package insert and manufacturer’s temperature and other specifications. (Optional) Procurement and Storage of Viral Hepatitis Test Kits and Reagents: procure a minimum of 10,000 viral hepatitis self-collection kits (50% hepatitis B and 50% hepatitis C) for distribution and corresponding reagents. Once a viral hepatitis self-test is approved by the FDA, confer with CDC if viral hepatitis self-tests shall be purchased instead of self-collection kits. Storage shall be in accordance with the package insert and manufacturer’s temperature and other specifications. (Optional) Procurement and Storage of PrEP Initiation and Monitoring Test Kits and Reagents: procure a minimum of 10,000 packaged PrEP initiation (20% standard) and monitoring (80% with minimum HIV and creatine tests) self-collection kits for distribution and corresponding reagents. Storage shall be in accordance with the package insert and manufacturer’s temperature and other specifications. (Optional) Surge Support for Procurement and Storage of Self-collection Test Kits: provide surge support for (c)-(f) by purchasing and storing up to 1,000,000 additional test kits and corresponding reagents in increments of 20,000 each. Task 3. Web-Based Portal: select a secure and appropriate platform for developing, hosting, and administering a web-based portal leveraging a cloud service provider or an existing system that will meet security requirements and comply with requirements to transfer the portal as specified in the SOW. Web-based Portal Requirements: provide a web-based portal service that has the capability to screen and register individuals and the ability to verify if individuals are providing fraudulent information to minimize the number of duplicate orders. The web-based portal shall have the capability for medical providers to order PrEP or other test kits for their patients with home delivery. The web-based portal shall be able to accommodate work funded by CDC partners at the same prices for test kits and services delivered under this contract. Designing the web-based portal: the web-based portal shall address relevant technical consideration and include input from CDC regarding the design of the portal and the forms. Screenshots of the questions for Office of Management and Budget (OMB) submission: assist CDC in finalizing approval of a full OMB package for the data collection by providing screenshots of questions from the forms for OMB submission. Technical Support: establish a communication system to provide technical support to registered consumers l. Monitor Progress during Development of the Web-based Portal: communicate progress of the development of the web-based portal during conference calls/webinars and in monthly progress reports. Monitor Progress during Soft-start and Full Implementation of the Web-based Portal: communicate the progress of the test kit orders to CDC during the conference calls/webinars and in monthly progress reports. Complete System Assessment and Authorization (SA&A) Process: comply with all Federal and HHS Information Security Program policies and requirements as described in the SOW. Prior to fully implementing the existing tools, complete the CDC SA&A process and obtain a valid authority to operate (ATO) for the portal front-end. Task 4. Shipping Service for Test Kits Shipping System and Process: administer a shipping system, fulfill orders within 7 days, provide discrete packaging, provide instructions and track shipments. (Optional) Return Label Shipping System and Process: free return shipping and instructions for packing and shipping for HIV DBS, STI, viral hepatitis and PrEP test kit self-collected specimens. Technical Support: provide technical support to consumers with questions or issues about the shipping of test kits and return shipping of self-collected specimens. Progress during Development of Systems and Processes to Support the Shipping of Test Kits: communicate progress of the systems and processes for shipping test kits and return shipping of self-collected samples during conference calls/webinars and in monthly progress reports. Monitor Progress during the Soft-start and Full Implementation of the Systems and Processes to Support the Shipping of Test Kits: monitor the shipping and fulfillment of test kits and the return shipping of self-collected specimens and communicate the progress to CDC during the conference calls/webinars and in monthly progress reports. Task 5. Returned Self-Collected Sample Receiving, Laboratory Testing, and Test Result Notification (Optional) Develop Protocols for Laboratory Testing: develop protocols for monitoring the shipping time and temperature requirements and receipt and storage of laboratory-based testing of self-collected samples. Develop a protocol for the notification of test results no later than 7 days to individual consumers and medical providers (PrEP test kits. Ensure that protocols are CLIA and CAP validated and that HIPAA protections are in place. (Optional) Receipt of, Laboratory Testing for and Test Result Notification for HIV DBS Self-collected Specimens: monitor return shipments of HIV DBS self-collected specimens to ensure that they meet time and temperature requirements and track the receipt and condition of HIV DBS self-collected specimens in the web-based portal. Conduct laboratory-based testing on self-collected HIV DBS samples in accordance with the approved protocol, notify individuals of HIV test results via the web-based portal utilizing the secured login information of the registered consumer. Provide instructions for appropriate clinical follow-up testing and care and options for partner referral and notification according to the approved protocol and in accordance with state laws for mandatory reporting of notifiable diseases, the notify health departments of positive HIV test results. (Optional) Receipt of, Laboratory Testing for and Test Result Notification for STI Self-collected Specimens: monitor return shipments of STI self-collected specimens to ensure that they meet time and temperature requirements and track the receipt and condition of STI self-collected specimens in the web-based portal. Conduct laboratory-based testing on self-collected STI samples in accordance with the approved protocol, notify individuals of STI test results via the web-based portal utilizing the secured login information of the registered consumer. Provide instructions for appropriate clinical follow-up testing and care and options for partner referral and notification according to the approved protocol and in accordance with state laws for mandatory reporting of notifiable diseases, the notify health departments of positive STI test results. (Optional) Receipt of, Laboratory Testing for and Test Result Notification for Viral Hepatitis Self-collected Specimens: monitor return shipments of HIV DBS self-collected specimens to ensure that they meet time and temperature requirements and track the receipt and condition of viral hepatitis self-collected specimens in the web-based portal. Conduct laboratory-based testing on self-collected viral hepatitis samples in accordance with the approved protocol, notify individuals of viral hepatitis test results via the web-based portal utilizing the secured login information of the registered consumer. Provide instructions for appropriate clinical follow-up testing and care and options for partner referral and notification according to the approved protocol and in accordance with state laws for mandatory reporting of notifiable diseases, the notify health departments of positive viral hepatitis test results. (Optional) Receipt of, Laboratory Testing for and Test Result Notification for Self-collected Specimens from PrEP Kits: monitor return shipments of self-collected specimens to ensure that they meet time and temperature requirements and track the receipt and condition of self-collected specimens in the web-based portal. Conduct laboratory-based testing on self-collected samples in accordance with the approved protocol, notify medical providers of test results via the web-based portal utilizing the secured login information of the registered medical provider. In accordance with state laws for mandatory reporting of notifiable diseases, notify health departments of positive HIV, STI, or viral hepatitis test results. (Optional) Technical Support: provide technical support to consumers with questions or issues about the receipt of self-collected specimens and notification of test results. (Optional) Monitor Progress: communicate progress of the systems and processes for receipt of returned self-collected samples, laboratory testing and test results notifications during conference calls and in monthly progress reports. Task 6. Reports Monthly Progress Reports: submit written monthly progress reports within 2 days after the last day of each month to communicate to CDC key findings and recommendations or action steps for improvement to the web-based portal and processes. Final base period progress report: submit a final consolidated report that includes lessons learned from base year tasks and recommendations for changes or enhancements as necessary to meet the deliverables for Option Period 1. The following tasks in the SOW will be conducted during the base period or during the one option period if exercised: Task 13. Data Disposition (a) Data Disposition Plan: including purging or destroying data, moving data to less expensive or more secure storage like the cloud or offline, coping files to legal hold archives, or encrypting sensitive content to protect against breaches. (b) Disposition letter: provide a one-page letter certifying that all data and associated information have been dispositioned as agreed in the data disposition plan. Task 14. Information Rights: CDC retains ownership of any user created/loaded data and applications collected, maintained, used, or operated on behalf of CDC and hosted on contractor’s infrastructure, as well as maintains the right to request full copies of these at any time. Knowledge Transfer Package: for transferring the web-based portal (software, associated codes and labels, and data management business processes) and transfer billing ownership of any Cloud Services subscription to the next organization and/or back to CDC. Technical Support for Web-based Portal Transfer. technical support for a period of one week to a new supporting organization (internal or external to CDC) to properly transfer the web-based portal. The scope of work for this requirement entails integrating the required and optional tasks listed above by type of tests. Required services for HIV rapid self-tests: The scope of work for this requirement encompasses required support for procuring the minimum number of FDA approved HIV rapid self-tests, accepting orders through a web-based portal and shipping and fulfillment of HIV rapid self-test orders to individual consumers targeted during CDC marketing periods for national testing days. The scope of work for this requirement encompasses shipping and fulfillment of individual orders during varied periods of demand and encompasses the ability of the system to accept orders placed by CDC partners. The scope of work for this requirement also encompasses optional services for surge support for procurement, shipping and fulfillment of orders for HIV rapid self-tests. The scope of work for this requirement encompasses reporting progress of services during conference calls/webinars and in monthly reports. Optional services for HIV DBS test kits: The scope of work for this requirement encompasses required support for procuring the minimum number of HIV DBS self-collection kits and corresponding reagents, accepting orders through a web-based portal, shipping and fulfillment of HIV DBS test kit orders to individual consumers, return shipping with tracking in the web-based portal, receipt and storage of returned specimens, laboratory testing on returned specimens, notification of test results to individuals and referrals to care to individuals. The scope of work for this requirement encompasses the ability to notify state and local health departments of positive test results per state laws. The scope of work for this requirement encompasses the ability of the system to accept orders for individuals that are placed and paid for by CDC partners and to and conduct services for CDC partners at the same prices in the contract. The scope of work for this requirement also encompasses optional services for surge support for these services related to HIV DBS test kits. The scope of work for this requirement encompasses reporting progress of services during conference calls/webinars and in monthly reports. Optional services for STI test kits: The scope of work for this requirement encompasses required support for procuring the minimum number of STI self-collection kits and corresponding reagents, accepting orders through a web-based portal, shipping and fulfillment of STI test kit orders to individual consumers, return shipping with tracking in the web-based portal, receipt and storage of returned specimens, laboratory testing on returned specimens, notification of test results to individuals and referrals to care to individuals. The scope of work for this requirement encompasses the ability to notify state and local health departments of positive test results per state laws. The scope of work for this requirement encompasses the ability of the system to accept orders for individuals that are placed and paid for by CDC partners and to and conduct services for CDC partners at the same prices in the contract. The scope of work for this requirement also encompasses optional services for surge support for these services related to STI test kits. The scope of work for this requirement encompasses reporting progress of services during conference calls/webinars and in monthly reports. Optional services for viral hepatitis test kits: The scope of work for this requirement encompasses required support for procuring the minimum number of viral hepatitis self-collection kits and corresponding reagents, accepting orders through a web-based portal, shipping and fulfillment of viral hepatitis test kit orders to individual consumers, return shipping with tracking in the web-based portal, receipt and storage of returned specimens, laboratory testing on returned specimens, notification of test results to individuals and referrals to care to individuals. The scope of work for this requirement encompasses the ability to notify state and local health departments of positive test results per state laws. The scope of work for this requirement encompasses the ability of the system to accept orders for individuals that are placed and paid for by CDC partners and to and conduct services for CDC partners at the same prices in the contract. The scope of work for this requirement also encompasses optional services for surge support for these services related to viral hepatitis test kits. The scope of work for this requirement encompasses reporting progress of services during conference calls/webinars and in monthly reports. Optional services for PrEP test kits: The scope of work for this requirement encompasses required support for procuring the minimum number of PrEP initiation and monitoring test kits and corresponding reagents, accepting orders from registered medical providers only through a web-based portal, shipping and fulfillment of PrEP test kit orders to individual patients of medical providers, return shipping with tracking in the web-based portal, receipt and storage of returned specimens, laboratory testing on returned specimens, notification of test results to medical providers. The scope of work for this requirement encompasses the ability to notify state and local health departments of positive test results per state laws. The scope of work for this requirement encompasses optional services for surge support for these services related to PrEP test kits. The scope of work for this requirement encompasses reporting progress of services during conference calls/webinars and in monthly reports. Anticipated period of performance: The period of performance will be the base period of 12 months with one, 12-month option period. Capability Statement/Information Sought: Interested offerors are requested to submit a capability statement, which shall include documentation of the ability to perform the requirements and information on previous successfully completed contracts for the same services. Specifically, please address the criteria listed below: Your opinion about the difficulty and or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; Your staff expertise, including your availability, experience, formal training, and any other training. Include capabilities for modifying and administering IT and cloud-based systems, technical assistance, project management, laboratory testing and clinical consultation. Include capabilities related to rapidly recruiting, on-boarding and retaining core, key personnel without significant interruptions of services. Describe policies, benefits and incentives for sustaining a high employee retention rate and/or demonstrated history of low employee turn-over. Include capabilities for tracking, monitoring, reviewing and managing the work of remote resources. Your current in house capability and capacity to perform the work. Include a description of existing systems to collect individual orders from patients or clinicians in a system that meets HIPAA privacy standards and is fully compliant with applicable HHS and CDC IT security policies. Include logistics system capability to package and ship and track test kits to fulfill orders and include the standard time from order to fulfillment. Include laboratory capabilities and validated protocols for HIV, STI, and viral hepatitis testing. Include standard time from receipt of specimen to notification of test results. Include capability to scale up program quickly based on demand, exercising of optional tasks and surge support. Include capability to meet IT security and other requirements in a timely manner. Include capability to accommodate orders from CDC partners. Your prior completed projects of a similar nature and scope. Include a brief description of similar work performed. Your corporate experience and management capability. Provide any examples of prior completed Government contracts., references, and other related information. Include the type of contracts (FFP/T&M), contract total dollar amounts and cite prime and/or subcontractor partnerships. Provide examples of current, established corporate partnerships, commercial associations or business relationships relevant to supporting work requirements that may indirectly benefit the Government at no additional cost. Information Submission Instructions: Please include a cover page with the following business information. The cover page does not count against the page limit for the capability statement. DUNS Number. Organization name, address, and point of contact. Do you have a Government-approved accounting system? If so, please identify the agency that approved this system. Business Size and Type of Business (e. g., small business, 8(a), woman owned, veteran owned, etc.) pursuant to the applicable NAICS code. Technical point of contact including name, title, address, telephone number, and email address of the individual(s) who can verify the demonstrated capabilities identified in the response. Contract’s point of contact including name, title, address, telephone number, and email address. You may recommend a different NAICS code for this acquisition but must include a thorough explanation / justification of why a different NAICS code should be chosen. Any other information that may be helpful in developing or finalizing the acquisition requirements. Page Limitation: Please limit your response to ten (10) single-spaced pages, including references, appendices, charts, illustrations, diagrams, and/ or resumes. Pages shall be formatted as follows: MS Word, 8 ½ x 11, 12 pitch, Times New Roman font with one (1) inch margins. Response Due Date: All responses to this notice must be submitted electronically. Facsimile responses will not be accepted. Please submit responses to Liubov A. Kriel, Contract Specialist, at
[email protected] Should you have any questions concerning this sources sought, please direct your questions in writing to the Contract Specialist Liubov A. Kriel at
[email protected]. The government will not respond to oral questions. Responses must be submitted no later than 5:00 pm, Eastern Standard Time (EST) by Tuesday, July 7, 2020 . Capability statements will NOT be accepted after the due date. Disclaimer and Important Notes. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Submissions will not be returned. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response.