Over the course of the last few weeks, in partnership with various partners, the State has been able to increase molecular diagnostic testing capacity in response to the Novel Coronavirus or COVID-19. Despite efforts to expand the existing public and private laboratory footprints, the overall capacity does not match the demand. As flu season approaches, the need to build additional capacity that is timely, equitable, and cost-effective is critical. Symptoms for the flu are similar to COVID-19, and as a result, healthcare providers will test for both, only further increasing the demand for testing. To that end, the State has entered into a contract with a major, publicly traded diagnostics company, to add up to 150,000 new laboratory COVID-19 molecular diagnostic tests per day with a contractual turnaround time of 24-48 hours.
Respondents looking to collaborate with other organizations may email company name, contact name, email, phone number, and a brief description of their service/solution/company to RFI2SpecimenCollection@dgs.ca.gov. Contact information will be listed here. Respondents may use this information to contact each other to initiate collaboration on a response to the RFI2.
2. Problem Statement
As California moves forward with our response to the COVID-19 pandemic, testing will be essential to our response. It will require us to have adequate testing that is timely, equitable, and cost-effective. Specimen collection is the process of obtaining tissue or fluids for laboratory analysis. It is an important first step in determining COVID-19 diagnosis. The State continues to build laboratory capacity among public and private laboratories to process specimens; however, a limiting factor is the collection of specimens and the transport of those specimens to the laboratory, which are both labor intensive and costly.
The ability to identify and track cases in California is dependent upon rapid testing and reporting of results. Introducing further efforts to test and process laboratory results are key drivers to address health disparities resulting from the pandemic and to implement safe reopening measures. This will allow California to more sufficiently monitor community spread and potentially reduce outbreak.
Additionally, building specimen collection capabilities in hard-to-reach areas of California, at essential workplaces, and in communities of color is critical, as there is a greater need to ensure equitable access to testing among these communities.
The State is seeking innovative ideas that will introduce new specimen collection services or processes, which will result in a better user experience that is seamless, timely, cost-effective, and convenient. The ultimate goal is to create a solution or service that meets the client or patient where they are so that testing becomes more accessible and equitable for both individuals who are disproportionately impacted by the virus as well as those who are at greater risk for the virus.
It is desired to identify these innovative solutions to the State’s pandemic response, with a goal of a working-solution deployed by early November of 2020.
The State of California is seeking a solution or service that would meet the following needs:
Demonstrate cultural and linguistic competence to ensure that the solution or service helps to eliminate racial and ethnic disparities in COVID-19 testing.
Collect specimen from individuals and transports it to the laboratory (ies) being developed by the State.
Collect specimens and have them delivered to laboratory (ies) within 24 hours of specimen collection.
Increase geographic distribution of testing on tribal lands, as well as in urban, suburban and rural parts of the State.
Improve access to specimen collection among communities disproportionately impacted and those at greater risk for COVID-19, especially communities of color.
Comply with State and federal guidance on specimen handling, and align with State laboratory specimen collection requirements.
Improve the ease and convenience of being tested by leveraging mobile and/or fixed capabilities.
Demonstrate a fair and reasonable price point.
Comply with State and federal privacy, information and security requirements.
Ability to report patient-level data on specimen collection activities, specifically related to race, ethnicity, sexual orientation, and occupation (see page 12 in FINAL_RFI2_COVID-19_Test_Specimen_Collection___Transport document attached below for full list of patient-level data elements).
The following requirements must be clearly outlined within the response:
The ability for the solution or service to be available 7 days per week and for varying hours to ensure equitable access.
The ability to reach individuals in various locations including workplaces, congregate living settings, schools, and under-resourced community settings.
The ability to pick-up, transport and deliver specimens to one or more State identified laboratories.
The ability to provide services that are culturally and linguistically appropriate in order to serve California’s diverse population.
The ability to provide reasonable accommodation to individuals with disabilities or limited mobility, including those who have access and functional needs.
The ability to collect specimen from patients of all ages.
The ability for an individual to register using an on-line, mobile device, and/ or telephone platform, and potentially in-person.
The solution must comply with all federal and state privacy requirements including HIPAA and must interface or connect with laboratory (ies) identified by the state;
The solution must collect and report all participant provided demographic data including: age, race, ethnicity, sexual orientation, and gender identity; and
The solution must collect and report to the State patient level and aggregate information regarding number of specimens collected daily; employment type and status of participants; health insurance information, and first time participant vs. recurring participant (see page 12 in FINAL_RFI2_COVID-19_Test_Specimen_Collection___Transport document attached below for full list of patient-level data element).
The ability to provide or partner with entities to deliver mobile and/or fixed capabilities that are both walk-in and drive-through. Ability to provide Wi-Fi, electricity, HVAC, canopy, refrigeration, storage, signage, distancing tape, traffic cones, portable toilets for participants, waste pick-up, biohazard waste removal.
The ability for the solution to be accessible in multiple languages, including English, Spanish, Chinese, Vietnamese, Tagalog, Korean, Armenian, Persian, Russian, Japanese, Arabic, Punjabi, Mon-Khmer, Cambodian, Hmong, Hindi, and Thai.
The ability for the solution to track appointments through features such as calendar sync, call reminders, email reminders, online booking, rescheduling, and SMS reminders. Participant can cancel the appointment at any time, allowing the appointment slot to reopen for other participants.
The ability to interface or connect with laboratory (ies) identified by the state and communicate test result data from designated State lab partner to participants (positive and negative) through preferred method (e.g., phone, email, text). The ability to provide instructions via phone or in person for individuals who test positive for how to appropriately isolate and what additional infectious disease and public health precautions they can take to keep family and friends safe.
The ability to collect samples in the absence of Internet connectivity (e.g., paper back up records, off-line access, etc.)
Other requirements that are not mandatory, but highly desirable, include the following:
The ability to procure Personal Protective Equipment (PPE) for staff and patients consistent with Centers for Disease Control and Prevention (CDC) and or California state guidance.
The ability to procure and distribute all testing kits and materials including: swabs (including pediatric), transport media, specimen collection bags, and all materials necessary to store and transport samples according to all laws and regulations appropriate to the means of transport.
The ability to collect third-party health insurance information and the ability to bill directly payers to recoup funds related to specimen collection on behalf of the State.
Demonstrate the ability to collaborate or partner with other organizations or entities to deliver on the concept.
The State proposes the following timeline in regard to the RFI2:
September 14 – RFI2 Released September 17, 9-11am – Virtual Conference 1: Join here. September 18, 1-3pm – Virtual Conference 2: Join here. September 14-19 – Questions to RFI2SpecimenCollection@dgs.ca.gov September 21– Submission Date September 24 – Respondent Notification to Move to Phase Two September 28 – Interview/Presentation/Demo September 29- October 2 – Finalists Develop Scope of Work and Contract Costs; and Review State’s Terms and Conditions October 2 – Finalists Submit Scope of Work and Contract Costs to State. October 5-October 8 – Negotiations on Scope of Work and Contract Costs. October 9 – Contract Awarded and Scope of Work Executed All applicants must review all Respondent Documents listed below.