By Todd Bartley, TalkWilliamsport.com
News@TalkWilliamsport.com
Talkwilliamsport.com has discovered a Request for Application #67-116 commonly referred to as an (RFA) seeking applications for the development of a “hub and spoke” testing system to be administered across six regions in the Commonwealth.
RFA #67-116 is looking for applicants to participate in a process to develop Pennsylvania Approved COVID-19 Testing Sites (PaACTS) and garner their share of a $60,000,000 grant allocation through June 2022.
The application deadline was extended earlier today from September 1, at 1:30 p.m. to “1:30 p.m. Sept. 4, 2020”, RFA 67-116 Addendum 2.
The details outlined for applicants suggest the Pennsylvania Department Of Health believes that COVID-19 will be around until at least June 30, 2022 – and possibly for another 6 years.
Outlined in meticulous granular detail in the Request for Application (RFA) #67-116 is the following:
Type of testing to be performed – “FDA” approved COVID-19 diagnostic and/or antibody testing”
Funding – grant from the CDC “under a cooperative agreement with the Department of Health
and Human Services”
Overall goal – “The overall goal of this funding is to expand the detection, surveillance, mitigation and containment of the COVID-19 virus.”
Term – anticipated grant term is Sept 1, 2020 – June 30, 2022. However, the budget spreadsheet that is also part of the RFA asks for budget details for six years. RFA 67-116 Downloadable Budget
“Equal access to testing” – “The ability to provide equal access to testing: This refers to the ability of an applicant to engage individuals across the region that may or may not have insurance coverage and conduct outreach to various ethnic and racial populations and individuals by sexual orientation and gender identity. All Pennsylvanians deserve equal access to care, especially during the COVID-19 pandemic”
Demographic data to be collected – “The Hub is required to develop and implement an intake tool that shall collect demographic information, including data on sexual orientation and gender identity (SO/GI), for each individual that is administered a COVID-19 diagnostic and antibody testing.”
Building a network – application must show ability to establish a “network of Spokes that can coordinate efforts to engage and increase access to approved high quality COVID-19 testing for individuals by June 30, 2022.”
Reporting – various reports are required at several points in time.
Budget – $39 million for year 1 from Sept 1, 2020 – June 30, 2021; $21 million for the second year period from July 1, 2021 – June 30, 2022
Regions – Year 1 – Sept. 1, 2020 to June 30, 2021
Region 1 – Southeast Counties – $11,610,000
Region 2 – Northeast Counties – $ 5,730,000
Region 3 – Southcentral Counties – $ 5,730,000
Region 4 – Northcentral Counties – $ 4,050,000
Region 5 – Southwest Counties – $ 7,410,000
Region 6 – Northwest Counties – $ 4,470,000
Total $39,000,000
Regions – Year 2 – July 1, 2021 to June 30, 2022
Region 1 – Southeast Counties – $ 8,610,000
Region 2 – Northeast Counties – $ 2,730,000
Region 3 – Southcentral Counties – $ 2,730,000
Region 4 – Northcentral Counties – $ 1,050,000
Region 5 – Southwest Counties – $ 4,410,000
Region 6 – Northwest Counties – $ 1,470,000
Total $21,000,000
The RFA can be found here: RFA 67-116
Recently launched initiatives by the Department of Health on spending or requested authority to spend:
- $25 million on 4,000 contact tracers was approved as an emergency request.
- $2 million on a smartphone app was approved as an emergency request.
- Contact tracing database solicitation period has closed with no report on contract award or funding amount
involved.
From RFA 67-116:
A. Information for Applicants
The COVID-19 virus has been shown to spread quickly through communities within the Commonwealth as well as United States creating a disruption of community and business activities and impacting the delivery of care by our healthcare systems.
Since the confirmation of the first case of COVID-19 in Pennsylvania, every county in the Commonwealth has been
affected as COVID-19 has spread from person to person due to exposure to individuals that may be symptomatic (that is, having fever, cough, shortness of breath, chills, muscle pain, headache, sore throat, and loss of taste or smell) or asymptomatic.
Many areas of Pennsylvania are also experiencing “community spread”, which means that COVID-19 is being transmitted through unknown sources and not from a known infected area.
Through this RFA, the Pennsylvania Department of Health (Department) is soliciting applications for the Pennsylvania Approved COVID-19 Testing Sites (PaACTS) program from Pennsylvania institutions and organizations that shall create a Hub and Spoke network of approved testing sites within six regions. These networks will facilitate access for individuals to receive COVID-19 testing to rapidly detect and identify cases of COVID-19 infection that lead to implementing appropriate clinical and community mitigation efforts. At minimum, each PaACTS program shall include a Hub and network of Spokes.
For the purposes of this program, a Hub is defined as an organization with a team of experts that shall oversee establishing approved testing sites (Spoke locations) within counties across a region and provide support to
those Spoke locations. A Hub shall include, but not be limited to, a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory approved to conduct COVID-19 tests and laboratory personnel including an individual who meets the standard of a CLIA approved laboratory director of high complexity testing. At a minimum, the services provided by a Hub to each Spoke shall include the training of personnel to administer and oversee the quality of tests provided to individuals and the collection, maintenance and reporting of demographic and testing results for mitigation efforts and research purposes and technical assistance on billing and insurance reimbursement for COVID-19 tests. A Spoke is defined as a location within a region that can offer FDA approved COVID-19 diagnostic and/or antibody testing, including specimen collection, to individuals while being supported by the Hub. Spokes can include but are not limited to health care providers, civic and community groups, pharmacies and laboratories.
Providers that are affiliated with academic institutes may also be used as Spokes. Each application must provide details on how the applicant shall develop and build Spokes that use either its existing network of health care providers, civic and community groups and laboratories, or create new relationships with health care providers, civic and community groups and laboratories within the region, or both. Each application must demonstrate the applicant’s ability to establish a Spoke or network of Spokes that shall increase access to approved COVID-19
testing. While staff time may be paid for by this Grant, the organization may not retain payment for what it billed commercial insurance or Medicaid. The Pennsylvania Approved COVID-19 Testing Sites Program will be funded through the Epidemiology and Laboratory Capacity (ELC) Enhanced Detection Funding administered by the
Centers for Disease Control and Prevention (CDC) under a cooperative agreement with the Department of Health and Human Services. The Grant program aims to address the COVID-19 pandemic by using a Hub and Spoke model that when implemented will increase access to testing using COVID-19 diagnostic and antibody testing and other Food and Drug Administration (FDA)-approved testing methods.
The Department is interested in funding applications addressing the establishment of PaACTS in a Hub and Spoke in each of the six identified regions within the Commonwealth to provide COVID-19 diagnostic and antibody testing to people in Pennsylvania. The overall goal of this funding is to expand the detection, surveillance, mitigation and containment of the COVID-19 virus.
The anticipated Grant Agreement term is Sept. 1, 2020 to June 30, 2022 subject to the availability of funding. If more funding becomes available from the Federal government, supplemental dollars could be provided to PaACTS Grantees.
The ability of the Hub to meet testing goals across a region:
There are two kinds of tests available for COVID-19: diagnostic tests and antibody tests.
Each applicant must explain the types of tests that shall be offered to individuals at each Spoke location and the reasons why each test will or will not be available. An awarded applicant shall demonstrate how its network of Spokes can meet a testing goal of providing access to COVID-19 diagnostic and antibody testing to 90% of the people residing across the counties within a region using the Department guidelines for COVID-19 diagnostic testing above and CDC interim guidelines for testing of
antibodies.
To determine the testing goals of a region, the Hub shall develop a geographic radius of each Spoke location that can provide the two types of tests to at least 90% of the individuals within that area.
Each application must also include policies and procedures to be used to administer tests based on Department guidelines for COVID-19 diagnostic testing
(https://www.health.pa.gov/topics/disease/coronavirus/Pages/Guidance/Testing-Factsheet.aspx)
and CDC interim guidelines for testing of antibodies:
(https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html).
i. High Priority.
Diagnostic testing shall be considered a high priority testing for the following
individuals:
a. Persons with symptoms of potential COVID-19 infection, including fever, cough,
shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or
diarrhea, and/or sore throat.
b. Hospitalized patients who have likely been exposed to COVID-19, regardless of
symptoms.
c. Residents in long-term care facilities or other congregate living settings, including
prisons and shelters, regardless of symptoms.
d. Persons >65 years of age, regardless of symptoms.
e. Persons with underlying medical conditions, regardless of symptoms.
f. Persons in critical and/or high-risk occupations, regardless of symptoms:
1. Workers in inpatient and outpatient health care facilities.
2. Workers in long term care facilities or congregate living settings.
3. Emergency/first responders and public safety personnel, including child
protective services, adult protective services, and domestic violence
providers.
4. Public health personnel.
5. Food supply chain workers (including farmers, food processing facilities
and warehouses, and grocery store workers).
6. Workers in critical infrastructure occupations.
7. Pharmacists and pharmacist technicians.
8. Military personnel.
ii. Medium priority.
Diagnostic testing shall be considered a medium priority testing for the
following individuals:
a. Persons likely to have been exposed to COVID-19 diagnosed individuals and identified through public health investigations (i.e., contact tracing)
b. Asymptomatic individuals as determined by the individual’s attending health care provider for medical diagnostic purposes based on the provider’s medical judgment in providing direct care to the individual.
iii. Antibody Testing. The Commonwealth offers guidance regarding diagnostic tests only.
Since it can take 1-3 weeks after infection to make antibodies, an antibody test may not be able to show if a person has a current infection. The Commonwealth does not know yet if having antibodies to the virus can protect a person from getting infected with the virus again, or how long that protection might last. At this time, the Commonwealth is working closely with the medical and scientific community to better understand the applicability and role of antibody testing.
If the applicant is proposing to make antibody testing available, the applicant shall develop policies and procedures based on the CDC’s “Interim Guidelines for COVID-19 Antibody Testing in Clinical and Public Health Settings”:
(https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html).
The ability of the Hub to establish policies, procedures and best practices to be used by the Spokes:
The Hub is required to establish policies, procedures and best practices for the Spokes to follow in administering COVID-19 tests to individuals. Policies and best practices, at a minimum, shall cover the following:
a. Testing methods for the COVID-19 virus.
b. Training of personnel to properly administer each different type of approved COVID-19 test.
c. Screening of uninsured, underinsured, and those who have private insurance.
d. Collection and reporting of personal information and testing data.
The ability of the Hub to collect and manage outcome data: Each application must demonstrate the Hub’s ability to collect, track and report testing results for individuals that will help inform public health policy decisions, drive mitigation efforts, and provide information for research purposes. The Hub is required to develop and implement an intake tool that shall collect demographic information, including data on sexual orientation and gender identity (SO/GI), for each individual that is administered a COVID-19 diagnostic and antibody testing. The
requirement is that the applicant collect data through their own electronic medical record system to allow for evaluation and research.
An awarded applicant shall be required to send a monthly progress report and a quarterly quantitative report to the Department.
The applicant must demonstrate that it shall be able to report all testing results through the Department’s Pennsylvania-Electronic Laboratory Reporting (PA-ELR) service. Information on how an awarded applicant can participate and enroll in the PA-ELR can be found at:
https://www.health.pa.gov/topics/Reporting-Registries/Pages/PA-ELR.aspx.
No paper reporting of test results shall be accepted by the Department under this program.
The Department will make awards for one application per region that meets the requirements of this RFA for a Hub and Spoke model established in counties across each of the following six regions:
Region 1 – Southeast Counties – Berks, Bucks, Chester, Delaware, Lancaster, Montgomery, Philadelphia and Schuylkill.
Region 2 – Northeast Counties – Carbon, Lackawanna, Lehigh, Luzerne, Monroe, Northampton, Pike, Susquehanna, Wayne and Wyoming.
Region 3 – Southcentral Counties – Adams, Bedford, Blair, Cumberland, Dauphin, Franklin, Fulton, Huntington, Juniata, Lebanon, Mifflin, Perry and York.
Region 4 – Northcentral Counties – Bradford, Centre, Clinton, Columbia, Lycoming, Montour, Northumberland, Potter, Snyder, Sullivan, Tioga and Union.
Region 5 – Southwest Counties – Allegheny, Armstrong, Beaver, Butler, Cambria, Fayette, Greene, Indiana, Somerset, Washington and Westmoreland.
Region 6 – Northwest Counties – Cameron, Clarion, Clearfield, Crawford, Elk, Erie, Forest, Jefferson, Lawrence, McKean, Mercer, Venango and Warren.
An Applicant must submit a separate application for each region it proposes to cover.
4. Deliverables
a. The awarded applicant shall establish a PaACTS program based on a Hub-and-Spoke model.
b. The Hub shall consist of at least two core staff members, one of whom must be a physician who is board-certified in internal medicine and one must be a practitioner, certified infection preventionist or epidemiologist with specialized training in implementing and maintaining infection prevention and control plans within a
hospital or health system.
c. The awarded applicant shall establish a network of Spokes that can coordinate efforts to increase access to approved high quality COVID-19 testing for individuals. The Hub shall meet a testing goal of providing access to COVID-19 diagnostic and antibody testing to 90% of the people residing across the counties within a region
using the Department guidelines for COVID-19 diagnostic testing above and CDC interim guidelines for testing of antibodies.
d. The awarded applicant shall develop policies, procedures and best practices for the Spokes to follow in administering COVID-19 tests to individuals and shall provide these policies to the Department by Nov. 1, 2020.
e. The awarded applicant shall provide a plan that will engage individuals across the region that may or may not have insurance coverage and conduct outreach to various vulnerable populations.
f. The awarded applicant will enroll or be enrolled in the Department’s Pennsylvania – Electronic Laboratory Reporting (PA-ELR) service by Oct. 1, 2020, including having been onboarded and successfully sending results to the Department.
g. The awarded applicant shall develop and submit monthly and quarterly report as required under this RFA.
5. Reporting Requirements
a) The awarded applicant(s) shall be required to submit a written mid-term report of progress, issues, and activities to the Department within 180 days after the Grant effective date. The mid-term report shall, at a minimum, identify if activities are proceeding according to the project plan, and explain any deviations from the project plan.
b) The awarded applicant(s) shall be required to submit a final written report within 30 days after the close of the Grant. The final report shall summarize the project and shall include the total number of each type of test provided and the total number of individuals tested with each type of test during the term of the Grant, demographic summaries of those tested by test type and result and any information on vulnerable populations and critical infrastructure workers. The final written report shall also present a forecast for how the PaACTS program shall continue operation.
c) The awarded applicants shall be required to request written approval from the Department prior to making any changes in the project that include, at a minimum, the following: replacing key personnel identified in the application, closing or relocating a Spoke location, adding or discontinuing any new types of COVID-19 diagnostic and antibody testing that shall be administered to individuals, and enhancements that affect the scope or methodology of the project.
d) The awarded applicant(s) shall develop a written report detailing the sustainability of the program and how it shall remain active and be funded after the terms of the Grant Agreement. This report shall be provided to the Department by Dec. 31, 2020.
e) The awarded applicant(s) shall be required to submit a written monthly report of the progress, issues, and activities as determined by the Department for each month covered by Grant period. The monthly report is due to the Department no later than 15 calendar days following the end of the reporting month.
Each monthly report shall, at a minimum, contain the following information:
1. The name and location of each Spoke.
2. An overview of the technical assistance the Hub has provided to each Spoke location.
3. An overview of the community engagement efforts and inclusivity practices incorporated into Hub and Spoke activities.
4. Whether any changes in the scope or methodology of testing within the program have been approved by the Department since the last monthly report was filed. The report should also include any proposed changes to scope or methodology of the program that is being considered in the future by the applicant.
f) The awarded applicant(s) shall be required to submit quarterly quantitative reports to the Department. Quantitative information shall at a minimum include information on demographic data including race, ethnicity, gender, sexual orientation, gender identity, and age.
Each quarterly report shall, at a minimum, contain the following information:
1. The number of individuals served at each Spoke location. This section shall include a total number of individuals served during the previous 3-months at each Spoke location covered by the report and shall at a minimum include information on demographic data including race, ethnicity, gender, sexual orientation, gender identity, and age.
2. The projected number of individuals expected to be tested for the remainder of the year at each Spoke location for which the report is prepared.
3. An evaluation of how testing services and activities are proceeding at each Spoke location.
4. The number of individuals by populations served.
g) All testing results shall be reported through the Department’s Pennsylvania-Electronic Laboratory Reporting (PA-ELR) service. Information on how an awarded applicant can participate and enroll in the PA-ELR can be found at: https://www.health.pa.gov/topics/Reporting-Registries/Pages/PA-ELR.aspx.
No paper reporting of test results shall be accepted by the Department under this program.
Note: The Work Statement, Cover Page, Certifications Form, Budget and Budget Definitions are not counted in the 30-page limit.
d) Budget – Use the downloadable format to present the budget request. Instructions
regarding completion of the budget can be found in the last worksheet of the
downloadable excel budget file.
The anticipated Grant Agreement term is Sept. 1, 2020 to June 30, 2022.
RFA 67-116 Downloadable Budget
The overall 22-month budget for the application shall not exceed the amount appropriated for each region including direct costs and overhead, and will be paid by monthly reimbursements. The budget needs to contain an Overall Summary in addition to a Summary with Budget Details for each year.
3. Budget Definitions
Personnel: This budget category shall identify each position by job title, hourly rate, and the number of hours per year allocated to the project. Fringe benefits are to be shown as a separate line item by percentage and shall include a detailed listing of the benefits being covered.
Consultant Services: This budget category shall identify the services to be provided by each
consultant including hourly rate and number of hours to be utilized under this Grant.
Subcontract Services: This budget category shall identify the services to be provided by each
subcontractor under this Grant.
Patient Services: This budget category shall reflect funding dedicated for patient services.
Equipment: This budget category shall reflect the actual or projected cost of any equipment $5,000
or greater. Justification for the purchase of any equipment must be included. Purchase of equipment
is not a priority of the Department.
Supplies: This budget category shall reflect expected costs for general office supplies including
personal computers and facsimile machines valued at less than $5,000 and laboratory supplies which
may include, but not be limited to, specimen collection supplies such as nasopharyngeal or anterior
nares swabs, viral transport media and reagents and consumables for laboratory instruments needed
to support this project.
Travel: This budget category shall include anticipated expenditures for travel including mileage,
hotels and meals. Mileage between sites for staff coordination between the Hub and Spokes and to
transport individuals to be tested is an allowed expense.
Other: This budget category shall be used for anticipated expenditures that do not fit into any of the
other budget categories such as telephone, printing, postage, outreach efforts, and indirect costs
(overhead, general, and administrative). Indirect rates cannot exceed the provider’s Federally
approved indirect cost rate schedule. In the description area under OTHER COSTS include the %
that the rate reflects, identify the budget categories to which the rate was applied, and list the specific
items that the indirect is paying for.
Note: A budget justification is not required for this RFA. If it is provided, there is not a page limit.
Also, please note that PaACTS Program funds can be used for several of the following frequently asked services:
• Purchase, administration and processing of approved diagnostic and antibody tests.
• New staff training at a Spoke location.
• Existing staff who work on PaACTS Program activities (Payment should only be used
for PaACTS Program activities).
• Rent for physical space for PaACTS Program activities.
• IT costs.
• Technical assistance and support provided to the Spokes.
• Community outreach and engagement efforts associated with testing.
So many questions arose from the RFA, the Department of Health offered an Addendum to attempt to answer them and as noted in the answer to Question 1, the federal government is regularly supplying Pennsylvania with testing supplies; “the state is receiving monthly shipments of specimen collection supplies from the Department of Health and Human Services (DHHS). The state will continue to share these swabs and tubes with healthcare facilities in Pennsylvania who need them.”
Pennsylvania Approved COVID-19 Testing Sites (PaACTS)
Date: August 24, 2020
Addendum Number: 1 RFA 67-116 Addendum 1
Addendum Changes: This addendum is to provide answers to all questions per the RFA Potential Applicant letter.
Question 1: If chosen to do testing at the Hub locations, will the State provide/source kits for testing? Or do we have to perform the testing from the limited testing supplies that we can individually source?
Answer 1: Organizations should plan to procure their own testing supplies through their typical purchasing channels, but currently the state is receiving monthly shipments of specimen collection supplies from the Department of Health and Human Services (DHHS). The state will continue to share these swabs and tubes with healthcare facilities in Pennsylvania who need them. The state does not have the ability to provide other testing supplies for specific instruments, such as the Cepheid GeneXpert, Hologic Panther, Roche cobas, and other instruments.
Talkwilliamsport.com will continue to provide updates on this developing story.
