Questions and Answers 75D301-22-R-72105 completed.xlsx
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- 75D301-22-R-72105
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This is a request for proposal from the Centers for Disease Control and Prevention for increasing community access to COVID-19 testing through contracts with private sector partners. The CDC seeks to maintain a minimum of 1,000 pharmacy, retail, or community-based testing sites and provide testing methods including PCR and rapid point-of-care tests. Contractors must propose fully loaded per test pricing, a minimum number of testing sites to be operational upon award, and plans to meet requirements for site locations, operating hours, turnaround times for results, and data reporting to HHS Protect. Questions are due by February 8th, 2022. The base period of performance is six months with five additional six-month option periods. The RFP includes standard terms for commercial item contracts, privacy and security requirements, and an evaluation criteria prioritizing technical approach, past performance, and price.
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| File | Type | Posted |
|---|---|---|
| Questions and Answers 75D301-22-R-72105 Completed Amendment 02-18-2022.xlsx | XLSX spreadsheet | |
| Attachment J.2 - Technical Proposal Tables Amendment 02-18-2022.xlsx | XLSX spreadsheet | |
| Attachment J.3 - Business Proposal Tables Amendment 02-18-2022.xlsx | XLSX spreadsheet | |
| Questions and Answers 75D301-22-R-72105 Completed Amendment 02-18-2022.xlsx | XLSX spreadsheet | |
| 75D301-22-R-72105 Amendment 02-18-2022.doc | DOC document | |
| Attachment J.3 - Business Proposal Tables Amendment 02-15-2022.xlsx | XLSX spreadsheet | |
| 75D301-22-R-72105 Amendment 02-15-2022.doc | DOC document | |
| Attachment J.5 - Past Present Performance Questionnaire.docx | DOCX document | |
| 75D301-22-R-72105 Amendment 02-04-2022.doc | DOC document | |
| 75D301-22-R-72105.doc | DOC document | |
| Attachment J.3 - Business Proposal Tables.xlsx | XLSX spreadsheet | |
| Attachment J.1 - Data Reporting Requirements.docx | DOCX document | |
| Attachment J.2 - Technical Proposal Tables.xlsx | XLSX spreadsheet | |
| Attachment J.4 - Question and Answer Template.xlsx | XLSX spreadsheet |
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Sheet1
| RFP 75D301-22-R-72105 | |||||
| Question | |||||
| Number | RFP or Attachment Page Reference | ||||
| (if applicable) | Question | CDC Response | |||
| 1 | Page 8, Section 4. Item 1# General Tasks Subsection A.i "ordering of the test by a licensed healthcare practitioner" | The PREP act provides pharmacists with the additional scope to screen, order, administer and report COVID-19 tests through October of 2024, however the length of this contract extends to June of 2025. Does CDC plan on extending the pharmacist scope provisions beyond October of 2024 | Offeror can propose that their pricing is contingent on the PREP Act being in effect for all periods of performance. | ||
| 2 | Page 8, Section 4. Item 3# Testing locations subsection A.iii-vi. | This section states that appointment capacity must be 28 tests per site per day and that testing hours must coincide with pharmacy hours. It also states that regular testing hours are 9am to 5pm. Many pharmacies operate until 8-9pm however lab pick up times and staffing can vary. Can CDC clarify what's required for testing hours? | Section C.4.3.A. refers to minimum criteria for testing availability (appointments or unique tests) and capacity. In accordance with C.4.3.A.vi, test appointments shall coincide with pharmacy hours. If pharmacy hours only run 9AM to 5PM, then 10% of sites shall provide testing for at least three hours before 9AM and/or after 5PM. Offerors may offer additional capacity or availability at their discretion so long as the minimum criteria in this section are met. Section C.4.3.A does not set criteria for lab pickup times. See asnwers to Q88 and Q104. | ||
| 3 | Page 2-3, Section B - Supplies Or Services And Prices/Costs and Page 17, Section 6- Period of Performance | Both sections reference duration of the award and Section B addresses pricing, neither address volumes. Will the funding be distributed like the current ICATT contract where vendors have to balance future investments against the risk of funding being secured? How will contractors know their budget for this contract award? | See page 57 of solicitation, section L.3 Additional Notices and Instructions to Offerors for specific instructions related to volumes. The third paragraph will be edited to address testing volumes to read "The Offerors are encouraged to propose the most appropriate mix of testing sites and maximum number and type of tests that align with their capabilities." See page 2, Section B - Supplies Or Services and Prices/Costs for information related to periods and performance. The government reserves the right to exercise the options and provide negotiated funding per the contract. Contract award will include negotiated funding for each period of performance. |
The 1 Job CLINs have been changed to 1 Lot. The 1 lot represents the total cost of tests performed. There will be a corresponding table to show the estimated number of tests, and the price per test.
| 4 | Page 2-3, Section B - Supplies Or Services And Prices/Costs - Base Period and Option Period Tables | Under the rows for ICATT Additional Testing, would you describe what this optional line item is for and why the value decreases form 250% of the referenced core task to 25% by Option Period 5? | This optional line item is for additional testing in case there is an increased demand for testing beyond the volumes proposed in the main CLIN for each PoP. The value decreases based on the estimate that any increased demand will go down over the life of the contract. The government reserves the right to exercise contract additional testing capacity in one or more intervals, as response to the pandemic may require, up to the specified percentages of the respective period of performance's base period funding. |
| 5 | Page 8, Section 3, Scope of Work | There is reference to the number of sites that the ICATT program will maintain and is subject to change - how much notice will be provided in advance of an increase or decrease of testing sites? | See revised language related to advance notice for expansion and contraction of surge sites and pharmacy sites (section C.4.3.A.). The government will provide a one (1) week notice to expand or contract surge sites. The government will provide four (4) week notice for expansion or contraction of pharmacy sites. |
| 6 | How will the government secure space after the contractor has made their recommendation(s)? Will that be a pass-through cost? | The government will reimburse the contractor for tests performed at a negotiated fully-loaded per test cost. | |
| 7 | Please confirm that "surge testing" will be billed under CLIN x002 for additional testing. | No. All costs associated with "Surge Testing" as defined in SUBSECTION A – DEFINITIONS is billed under CLIN x001. CLIN x002 is an optional line item for additional ICATT Testing that may or may not be exercised. | |
| 8 | Can we assert a preference for one of the seven regions? | Contractors shall operate in multiple regions in accordance with Section C.4.3.A.i. If the offeror has a preference for regions, this should be included in the proposal for the government's consideration. | |
| 9 | (4.8.F.a-e) | "Self-collection kits may be provided by the Contractor, test site partner, state/local government, or the federal government. The source of test will be decided at the sole discretion of the Government." Please provide clarification on how the source of test will be determined, and whether the decision will be made in consult with the Contractor especially as it concerns PCR testing. | The contractor should propose fully-loaded per test cost unless otherwise specified in the statement of work. The following sentence provides instructions on how to propose. C.4.12.A. "Contractor shall include pricing structure for test administration when the test kit is provided by the Government. If the test provided by the government requires additional testing platform equipment (e.g. readers), the Government will supply this equipment as government-furnished property; the list of equipment will need to be confirmed as necessary by the government prior to procuring it. " The location and population tested will dictate the source and kind of test. |
| 10 | (Sec 3) | "The Contractor shall maintain the capability to provide wrap-around services under this contract. Distribution of informational resources shall be required." Can the government provide a specific definition of “informational resources”? | Informational resources is defined as written or oral guidance provided to the patient to link them with appropriate wrap-around services depending on their test result. For example, at pharmacy sites where COVID-19 vaccinations are available, the Contractor shall provide information on how to schedule a vaccination appointment or, if available, offer a walk-up vaccination to any patient who receives a negative COVID-19 test result and who has not already been fully vaccinated against SARS CoV-2. |
| 11 | (4.16.B) | Section 4.16.B states that “Contractor shall offer a vaccine to any patient who receives a negative COVID-19 test result. Vaccination shall be offered at time of negative result notification to the patient.” Please confirm that offering an appointment for vaccination would meet this requirement. Many pharmacies don’t vaccinate on a walk-in basis. | See revised language for C.4.16.B. |
| 12 | (4.17) | What are the specific requirements for providing reasonable assistance foreign or sign language interpretation (4.17) at testing sites? Is an interpreter required onsite to be in compliance? | The contractor shall propose testing services within their capabilities and fully-loaded per test cost. If the site supports populations where impaired or handicapped test takers frequent, the contractor shall provide the necessary support. |
| 13 | Please provide a specific definition of “testing center”. | See revised language for "Testing Desert" definition. | |
| 14 | Is a physical voucher/requisition per test necessary in all cases? | No, a physical voucher is not required as a long as the Contractor can link the patient to the appropriate registration record. | |
| 15 | (4.1.iii) | Please provide details on ensuring security while Contractor staff is onsite and the number of security personnel per Contractor staff member that will be required. | At surge sites, the Contractor shall provide an unarmed security guard who can contact local police and deescalate low level security concerns when conditions warrant security presence and/or at the recommendation of the local jurisdiction. Reference removed from C.4.1.iii and clarified in C.4.11.C.ii.5 |
| 16 | (4.5.iii) | "Provide detailed guidelines for applicable testing scenarios, such as testing due to travel, employment, school attendance, exposure, or illness." Is it expected that the Contractor provide quarantine/isolation guidelines? | Yes see revised language in C.4.5.A.iii |
| 17 | (4.8.h.ii) | "If required by state regulations and not exempt by PREP Act or other federal authority, the Contractor shall ensure a licensed healthcare provider capable of providing guidance for the use of tests is available as part of the distribution of self-testing kits." Does the ICATT program require this guidance, where required, to be in-person? | Offerors must ensure that operations under this contract are carried out in compliance with all applicable laws and test manufacturer instructions. ICATT does not have additional criteria requiring in-person guidance as long as support is in compliance with laws and manufacturer instructions. |
| 18 | (4.14.C.ii) | "The patient is responsible for returning completed sample collection kits to drop off locations for testing, such as pharmacies drop boxes or smart lockers, for pick up and testing by the Contractor." (4.14.C.ii) Is UPS shipment acceptable under the Home Self-Sample Collection and Drop-Off circumstance? | Pre-paid return shipping containers via any shipping provider that can transport Category B specimens are acceptable. |
| 19 | (4.11.c.xi) | Is FedEx the required vendor for surge site specimens? | See revised language C.4.11.c.xi. |
| 20 | (4.16.B) | Will the government provide clarification on vaccination requirements at pharmacy sites? The contract stipulates that vaccine work performed by the Contractor will not be covered. How does the government contemplate this requirement to be accomplished? | See revised language C.4.16.B |
| 21 | (9.A.3-4) | We are asking for a correction to reflect that, yes, we are indeed processing PHI and PII under this solicitation. This is believed to be an oversight. | Yes, PHI and PII will be processed under the awarded contracts. |
| 22 | Section 8 and Table 5 | 1. When a contractor submits for a Mandatory Setting must they also submit for both Mandatory Test Types? | Yes, see footnote on revised crosswalk table. |
| 23 | Section 8 and Table 5 | 2. In the Pharmacy Sites Mandatory Setting, would it be acceptable to submit for just Swab and Send or Home Sample Collection and Send/Drop for example? | Pharmacy sites must offer a swab and send test option. see revised cross walk table to remove send/drop and provide clarification. |
| 24 | Page 2 - Section B of RFP - Supplies/Services - Prices and Costs | Who completes this section? | The contractor should complete Section B. See revised language for completion of Section B. |
| 25 | Page 7 of RFP - Scope of Work | Can you define surge testing - i.e. will increase in capacities at existing sites be considered surge testing? | See "testing sites" definitions on in Section C.1.A definitions table. |
| 26 | Page 10 - 3Aii | Can you provide current SVI document or location to retrieve? | See Section L - Instructions, Conditions, And Notices To Offerors; Technical Proposal/Proposed Activity Checklist 1.b. (page 60). Individual site information can be looked up by address here: https://svi.cdc.gov/map.html. Bulk SVI data can be downloaded from CDC here at the census tract or county level: https://www.atsdr.cdc.gov/placeandhealth/svi/data_documentation_download.html. |
| 27 | Page 11 - 8B | Are pharmacy technicians able to oversee swabbing process? | Offerors must ensure that operations under this contract are carried out in compliance with all applicable laws, test manufacturer instructions and CDC guidelines. |
| 28 | Page 13 - 10A | Will there be allowances for longer TAT during periods of high demand and/or inclement weather? | See revised language in C.4.10.A |
| 29 | Page 16 - 15 Submission of Specimens | Is this required or optional? | This is a required task. |
| 30 | Page 16 - 16 B | Does this info regarding vaccines need to be provided if person is already vaccinated? | Please see revised language to section C.4.16.B |
| 31 | Page 16 - 16C | Will the EUA be modified to allow pharmacists to prescribe COVID 19 oral therapeutics? | Modifications of oral therapeutic EUAs is not the responsibility of the CDC. |
| 32 | Page 16- 18A | Can you provide additional details to clarify how this would work? | Sites are required to provide additional services as needed by the site. For example (C.4.16), if testing is performed at a pharmacy that offers vaccinations, the contractor should provide information on the availability of COVID vaccinations (see Q11). For example (C.4.17), where additional services are needed by test takers with disabilities that frequent a site, or if the site is dedicated to a vulnerable population with disabilities, the contractor shall make the support services available (see Q12). Section C.4.18, if exercised by the government, provides funding for additional testing in the event of an increase in the demand for testing beyond the amount in CLINs X001 (see Q4). |
| 33 | RFP Amendment, Section 3, Testing Site Locations, page 11, A. and vi., "The contractor shall operate and sustain a minimum of 1,000 pharmacy, community, and / or retail testing sites concurrently." "For pharmacy sites, testing hours shall coincide with pharmacy hours." | Can the government please clarify the actions required for Pharmacy locations that the Prime contractor is to perform? The assumption is the Prime contractor will partner or subcontract with Pharmacies (e.g., Walgreens, CVS) to perform any of the testing COVID, Multiplex, etc.. The Prime contractor or government could provide PPE and/or COVID Tests (i.e., POC, OTC) to reduce the billing costs from the Pharmacy as will be a capped rate as stated in the RFP. | The contractor shall distribute and/or perform COVID tests as the prime contractor or by partnering or subcontractor with other contractors to perform the testing services. See Q9 for proposal instructions when testing material or consumables may be provided by the government. |
| 34 | Page 2 and Page 3 | The Government has established a base 6 month service period, with five six month option periods (essentially allowing the government to end the contract every six months). Is there a termination right for the vendor? | No. Reference Section I-2 clauses I-2.2 FAR 52.217-8 Option to Extend Services (Nov 1999) and I-2.3 FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) |
| 35 | Page 6, Bottom of Page 7 and Page 10 | Will the Contractor be permitted to contract/sub-contract with our partners/network of Federally Qualified Health Centers, Rural Health clinics, or Tribal Health Centers to support the scope of testing needs (assuming they are not awarded under this grant)? | See Q33. |
| 36 | Page 9 and Page 10 | The Government desires to have capacity to maintain and test at up to 20,000 sites through the ICATT program, but the Government reserves the right to allow the Contractor to operate less than 1,000 sites depending on the needs/constraints of the program. Is there a minimum testing volume (Daily) for 20,000 sites? Is there a minimum testing volume (Daily) for 1,000 sites? | Please refer to Section C.4.3.A.iii-vi. |
| 37 | Page 13 | The Government requires lab results to be reported within 48 hours. Does the Turn Around Time (TAT) clock begin ticking the hour the sample is drawn or is it measured by the day of collection? | See revised language Section C.4.10.A |
| 38 | Page 14 | Are there guaranteed or minimally expected volumes at surge locations? | The contractor should propose minimally expected volumes at their full-loaded per test price point proposed. The contractor shall notify the government if site closures are planned due to low testing volumes. (Section C.4.4.G) |
| 39 | Page 14 | How many surge sites are anticipated to be needed by month by US Region over the course of the contract? | As per Section L - Instructions, Conditions, And Notices To Offerors/Proposed Activity Checklist.2, the contractor shall propose a maximum number of proposed ICATT surge sites and a minimum number of surge sites acceptable at contract award. Current program surge sites range from 25-60 separate sites with an average short term duration of 3 weeks. |
| 40 | Page 17 and Page 18 | Will the two incentive payment measurements be calculated on a national level, regional level, state level or by individual provider? | No. Vulnerable PoP Incentive: This incentive applies to any combination of tests provided or conducted at pharmacy and retail locations under this contract, and will be calculated by the total for each individual provider. |
Billing Incentive:
(1) "laboratory tests performed or collected in pharmacy or retail locations under this contract
(2) "point of care tests performed in pharmacy or retail locations" under this contract.
| 41 | Page 17 and Page 18 | Can you clarify how the incentive payment will be calculated? Is it the baseline of a certain date or does it start in June on the commencement of the agreement. | See response to Q40 |
| 42 | Page 31: Special Contract Requirements "H.1 CDC H005 Data Subject to Privacy Requirements" | Please confirm nothing further is required than the current restrictions that apply under HIPAA | H.1 lists the type of data subject to the Privacy Act clause. |
| 43 | Page 31 and Page 32: H.2 CDC100_0003 Public Access To CDC Funded Digital Public Health Data (Nov 2018) | Are there any further reporting requirements for laboratories on the pvosiion of COVID-19 results? If there are additional reporting requirements please explain. | The contractor must provide a Data Management Plan (DMP). Suggested templates and tools are provided as links. |
| 44 | Page 34 and 35: H.5 CDCA_H042 Records Management Obligations (Jun 2020) | Please confirm nothing further is required than the current restrictions that apply under HIPAA | The contractor must comply with requirements C.1-10 of H.5 CDCA_H042 for prime and sub-contractors for all federal records. |
| 45 | Page 38 | It is unclear what government information employees would have as a result of performing services under this agreement. All employees are subject to confidentiality policies and are trained on privacy such that a separate independent NDA would not seem to be required. If required please confirm that only those employees specifically working on aggregated HHS reports (if any are required) are subject to this requirement. | Since the contracts will not require access to CDC or HHS information systems an NDA is not required. |
| 46 | Page 38: H.8 CDC0.H049 Non-Disclosure Agreement for Contractor and Contractor Employees (Jun 2020) | HIPAA training and policies require confidentiality for data entered into the HHS Protect. Individual NDAs for each employee (all of whom are subject to HIPAA training requirements) would be overly burdensome. Please advise if anything further beyond HIPAA requirements is required and, if so, if it could be restricted to those employees directly involved in data entry into the HHS Protect. | Since the contracts will not require access to CDC or HHS information systems an NDA is not required. |
| 47 | Page 43 through Page 47: I-2.1 FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items (Jan 2022) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a | Would mandatory training under HIPAA privacy policies satisfy these requirements? | 52.224-3(c)(1) lists the information to be covered in the training. If the contractor's mandatory training covers this information then the requirement is satisfied. |
| 48 | N/A | Will you be accepting different pricing models and price points for different access points (i.e., Suge test sites vs Drive through testing) | The contractor should propose a fully-loaded per test price model that aligns with the sites proposed. The Offeror should include assumptions for test provision in their proposal to address different sites proposed. |
| 49 | N/A | Is there flexibility in the number of appointments available by location based on demand and labor? | The sites proposed must meet the minimum test per day requirement listed in section C.4.3.A.vi. |
| 50 | Section C8 | Can you clarify the expectations for "diagnostic" sequencing? Does this mean it is run in a CLIA lab or other regulatory framework? Does it mean results are entered into a health record be returned to the physician/patient? | See revised "genomic sequencing" definition under "testing methods" in definition table. |
| 51 | Section C9 | Do the Baseline Security Requirements apply to this contract (i.e. does A.1.a. Or A.1.b apply?) The note in regards to PII seems to imply that no government systems will be leveraged in this contract in a way that involves PII, but we’d like clarification if government systems or government information will otherwise be implicated in this contract (and if so, how?). | The contractor will protect all PII and any other sensitive data/information in order to ensure the confidentiality, integrity and availability of the data. |
Please also refer to Sections C.9.3 and C.9.4
| 52 | Section C9 | Which provisions under Section 9 are implicated under this contract if there is no PII involved? | All section C.9 provisions apply. The contractor will protect all PII and any other sensitive data/information in order to ensure the confidentiality, integrity and availability of the data. | |
| 53 | Section C9 | Are Contractor systems (and/or any subcontractor systems) required to be compliant with FISMA? NIST 800-53? NIST SP 800-171? Fedramp? FIPS 140-2? | Not applicable. | |
| 54 | Section H | Under this contract, do we only need to report data directly to CDC, or do we additionally need to make such data publicly available? | Section H concerns the records management obligations for (including handling, maintenance, and retention requirements of) all Federal records generated or handled under this contract. Data reporting shall be performed in accordance with the requirements of Section 2 and Attachment J.1. De-identified data should be reported to HHS Protect and other local, jurisdiction or state reporting system. | |
| 55 | Section H5 | Does CDC consider the information collected and records kept under this contract to be Federal Records, subject to H042? | Please refer to Section H.5.B., Definitions. | |
| 56 | FARS Clause 52.227-17 (Rights in Data, Special Works) | What information is subject to 52.227-17(c)(2) so that contractor would be required to get permission from CDC before disclosing or using data outside the scope of the contract? Does this include using the data for further research? | This applies to data containing personally identifiable information such that the disclosure thereof would violate the right of privacy or publicity of the individual to whom the information relates. | |
| 57 | N/A | Through working with Operation Expanded testing, PerkinElmer has acquired multiple standing orders to conduct PCR testing in Nevada, California, Arizona, Oregon, Washington State, Hawaii, and Idaho. How does the ICATT program contemplate the use of physician orders to conduct testing? Will the USG facilitate acquiring physician orders to conduct testing? | See answer to Q27. | |
| 58 | N/A | If an offeror is awarded for a region using only the required two tests, will the offeror be able to implement more optional tests as they get FDA approval? | The Offeror should propose the technical approach to accomplish the tasks in the SOW for the government's consideration. There are three mandatory test types. The Offeror shall propose a mix of test types, number of tests and mix of sites that aligns with their capabilities. See revised cross walk table. | |
| 59 | N/A | Our firm works with many partners and has established relationships with universities, other companies (specializing in PCR testing, testing kits, and testing data management and workflow), schools, and community testing sites. How would these relationships be viewed and can multiple entities submit a joint proposal, or should only one entity submit a proposal as the prime contractor, listing its partners? | Each proposal submitted with be evaluated separately and on its own merit. If partnering or subcontracting to meet the minimum requirement, the proposal should be submitted by one prime contractor. | |
| 60 | Page 59 of 64 Mandatory Capabilities Checklist | When considering "Having prior experience over the past 2 years operating at least 500 COVID-19 testing sites," is this 500 COVID-19 testing sites operating over the course of the two years (having submitted at least a minimum amount of samples) or must they have been operating and submitting samples at the same time, totaling 500 sites congruently testing at the same time, within the 2 year timeframe? | Offerors must have prior experience over the duration of two years; sites did not have to be open congruently over the two-year timeframe. | |
| 61 | Page 59 of 64 Mandatory Capabilities Checklist | What is considered a testing site for the purposes of this RFP? | See response to question 25. | |
| 62 | Page 59 of 64 Mandatory Capabilities Checklist | Having worked with the SVI index extensively in Operation Expanded Testing, Hawaii has their own metric to track medically underserved areas and we utilized their metric to determine if a testing site was considered medically underserved in addition to SVI where applicable. For the Mandatory Capability of having "At least 50% of proposed sites which were located (or served communities) in intermediate to high SVI census tract OR at least 250 sites must be located in such areas," will Hawaii's metric for medically vulnerable populations be counted towards the 50% intermediate to high SVI threshold? | See Community of Interest definition, RFP, Section 1, Subsection A. CDC uses census tract SVI in combination with other factors to approve or reject sites. The Offeror can submit sites in medically underserved areas with additional justification for why these sites should be included. | |
| 63 | Page 16 of 64 Test Crosswalk table | Regarding Optional Test Types, specifically POC and OTC Self Tests, does HHS have guidelines specifically with regards to this program on how POC and OTC Self Tests should be reported to HHS protect? | See Attachment J.1 - Data Reporting Requirements. For OTC tests specifically, see Section E. For OTC tests HHS does not expect results reporting. | |
| 64 | RFP page 66 - CDC100_0005 Evaluation of the Data Management Plan (DMP) (Nov 2018) | In which volume should the Data Management Plan be presented? | Data Management Plan should be a component of Volume 1. | |
| 65 | Attachment J.2 instructions, | |||
| in Table 3 | "The Offeror should complete the Proposed Site details table for each testing site proposed." | |||
| Should each site be a separate table in a new tab, or all sites as rows or columns in one table on one tab | Each site should be an individual row in one table on one tab. | |||
| 66 | Cover page | The solicitation is not indicted as being DPAS rated. Has the government considered adding a rating to this contract to support prioritization of supplies to the awarded contractor(s)? | We have added local language, but we are not using DPAS ratings at this time. | |
| 67 | § C.4.2.I: | The RFP text indicates a file reference error, please confirm the relevant reference. | See revised language Section C.4.2.I. | |
| 68 | Page 20/64 - § C.9. A.10: The RFP text "D for baseline deliverables." | What does this represent? | This hsould have been a table, and has been corrected. | |
| 69 | Page 21/64 - § C.9.B.1: | Does the government continue to provide the referenced CDC SAT, Privacy, and Records Management training annually after the initial contract award training, or is it the contractor's responsibility to develop and provide compliant training to its personnel? | Since the contractor will not access any HHS or CDC network, this training is not applicable. | |
| 70 | § E: § L.3 | These sections identify this contract as a commercial item procurement pursuant to FAR Part 12 and incorporates FAR 52.212-4, Commercial Item Terms and Conditions. § E of the solicitation, however, incorporates by reference FAR 52. 246-54, Inspection of Services-Fixed Price (Aug 1996). Should this clause be removed given that the contract already includes the commercial inspection clause at FAR 52.212-4(a)? | See revised solicitation to remove clause from section E. | |
| 71 | Page 34/64 - § H.5.C.6: | The RFP states, “The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts.” | ||
| Are subcontractors who are included in contractor's proposal considered approved upon contract award, or will the contractor still be required to re-submit for approval post-award to use these named subs? [Internal Note to Color: If you do not intend to use subcontractors in the performance | Award of the contract based on the proposal constitutes concurrence of subcontractors included in the proposal. | |||
| 72 | Page 45/64 - § I-2.I(c)(1): | The RFP leaves unchecked the FAR clauses relating to Service Contract Labor Standards obligations (e.g., 52.222-41 et seq.). Please confirm the Service Contract Labor Standards do not apply to this contract. | This was an oversight and Service Contract Labor Standards obligations (e.g., 52.222-41 et seq.) applies for certain subcontracted positions. | |
| 73 | Page 61/64 - § M, Business Proposal Eval: | The RFP states, "Offerors satisfying the technical evaluation will progress to the business proposal evaluation." While two of the three technical evaluation components are pass/fail only, one component (Technical Approach and Transition In) is evaluated and assigned an adjectival rating. | ||
| What does it mean for an offeror to "satisfy the technical evaluation"? Is there a minimum adjectival rating a proposal must receive under the Technical Approach and Transition In component to proceed to the Business Proposal evaluation phase? | Satisfying the technical evaluation means that the contractors proposal is evaluated as “technically acceptable,” and is among the highest rated proposals should a competitive range be established. | |||
| 74 | Page 61/64 - § M, Basis of Award: | What are the relative evaluation weightings of the two non-pass/ fail proposal elements, Technical Approach and Transition In versus Price? For example, are they of equal importance, or is one more or significantly more important than the other? | The two non-pass/fail elements of technical approach, transition-in, and price are listed in descending order of importance. | |
| 75 | Page 61/64 - § M, Past Performance: | The RFP indicates that Past performance is a pass /fail evaluation factor. The RFP states that “Evaluation of past performance will be based on performance documentation or any other pertinent information available to the Government. The Government reserves the right to consider the Offeror's past performance not specifically provided by the Offeror." |
RFP § L, however, does not identify any past performance information to be submitted by the offeror.
Please clarify what the government considers to be relevant past performance information that would aid the government in its evaluation. For example, will the government consider only the contractor’s performance on prior federal contracts, or will it also consider performance under state, local, or private/commercial contracts?
| Will the government amend the RFP's proposal volume and/or page limits to enable contractors to submit past performance information to aid in the government's evaluation? | Relevant past performance will be reviewed in CPARS and government-provided questionnaires and the questionnaires will not count as part of the proposal page count. | |||
| 76 | Are you able to provide us with anticipated testing volume? | No. Offeror should refer to attachments J.2 and J.3 and corresponding sections within the statement of work. See the answer to Q3. | ||
| 77 | Are you able to provide us an anticipated testing timeline/go live date? | See Section L - Instructions, Conditions, and Notices to Offerors/Proposed Activity Checklist. "A minimum of 1,000 proposed sites with a minimum of 500 sites being operable upon contract award." | ||
| 78 | In reference to" Home Sample Collection and Send/Drop" we believe we may have seen it listed as mandatory and then optional can you clarify? | Revisions to Additional Notices and Instructions to Offerors (page 57) to remove Home Sample Collection and Send/Drop from the list of optional to propose test types. | ||
| 79 | RFP, Section 4, para. 14, pg. 15 | Section 4, para. 14 of the RFP states: “The Contractor shall provide at least one testing approach independent of the need for a drive-through that can be implemented at pharmacy sites.” That section then describes two alternatives ((i) Parking Lot/Offsite or (ii) Home Self-Sample Collection and Drop Off). The Test Crosswalk, however, flags PCR testing and Home Sample Collection as required. Please confirm whether both testing modalities are mandatory? | Revisions to the Text Crosswalk Table (page 16). | |
| 80 | RFP, Section 4, para. 3.d., pg. 10 | RFP states “The Contractor shall abide by all federal and state scope of practice laws, regulations, and policies.” Can we assume that current authorities granted to pharmacists to order and administer COVID-19 tests and to pharmacy interns and technicians to administer COVID-19 tests will remain in place for the period of performance and any additional periods of performance? Can we assume that current authorities granted to Nurse Practitioners to supervise, via virtual means, other trained personnel who administer COVID-19 tests will remain in place for the period of performance and any additional periods of performance? If not, does CDC agree that elimination or expiration of such authorities constitutes a "change" under the requirements of the Contract? | Offeror can propose that their pricing is contingent on the existing authorities currently in place to allow testing by pharmacies for all periods of performance. See answer to Q1. | |
| 81 | RFP, Section 4, Test Crosswalk Table, pg. 16 | The Test Crosswalk Table refers to "Swab and Send (PCR)" as a mandatory test type. Is rapid, point-of-care PCR testing an acceptable option to Swab and Send PCR? | No, rapid, point-of-care PCR testing is not considered a Swab and Send PCR test. | |
| 82 | RFP, Section 9, para. G.6., pg. 22 | RFP states "The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Out-Processing Checklist (http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract." The link to the Out Processing Checklist produces an error message. Please provide a PDF copy of the Checklist. | Contractor will not require access to CDC campuses or networks so this checklist is not needed. | |
| 83 | RFP, Section 1, subsection A, Community of interest definition, pg. 4 | Please confirm source of data (e.g., demographic composition, transmission rate, vaccination rate) to be used for this definition and whether the analysis will be updated periodically (and, if so, on what cadence). | Demographic data comes from the US Census and are not updated on a regular cadence. Vaccination and case rates come from USG data and are updated daily. | |
| 84 | RFP, Section 4, para. 1.A.iii. pg. 8 | The RFP states the contractor shall "[c]coordinate with state and local government and law enforcement to ensure security is present when Contractor Personnel are on site." Given the need for security varies greatly depending on the location and nature of the testing site, please confirm this requirement is applicable only when security details are necessary based on the specific circumstances of the testing site. If security is necessary, will CDC reimburse contractors? Often state and local do not have the resources and private security must be arranged and/or state and local want to be paid for such services given reduced budgets. | See answer to Q6 and Q15. | |
| 85 | RFP, Section 4, para. 2, Program management and staffing, pg. 8-9 | What support will the government provide in connection with securing supplies in the event of any shortages? | Reference RFP SECTION 5 – GOVERNMENT FURNISHED MATERIALS. As stated in the solicitation, the government may provide PPE and tests. The contractor should propose a cost structure that addresses a fully-loaded test cost for contractor-purchased and government-provided. The Offeror should include assumptions for test provision in their proposal to address test shortages. See the answer to Q9. | |
| 86 | RFP, Section 4, para. 3.A.iii, pg.10 | The RFP states "iii. At least 10% of sites shall operate under extended hours based on testing demand. The Government defines extended hours as at least 3 hours before 9 AM or after 5 PM." Please confirm this requires 10% of the testing sites to have hours either from 6AM to 9 AM or from 5PM to 8 PM --- not 6 AM to 8PM. Alternatively, can a contractor, at its discretion, extend hours on both sides of normal hours -- e.g., 7 AM am to 6 PM? | Any combination of three hours outside of 9 AM to 5 PM is acceptable. | |
| 87 | RFP, Section 4, para.2.K.i, pg. 9 | During the pandemic, certain allowances have been in place that allowed for CLIA certificates of waiver to be granted for parking lots and overflow locations and CMS and the state agencies have been quick to respond to applications. Given the need to respond rapidly to establish surge sites, can we assume those allowances and commitments to responding rapidly to new applications will continue during the period of performance? | Yes, the offeror's pricing is contingent on the CMS regulations being in effect. The CDC will facilitate the application for CLIA certificates of waiver with CMS and state governments on behalf of the contractor and any delays due to this process will not be held against the contractor as long as they are immediately responding to information needed for this process. Offeror can propose that their pricing is contingent on the CMS regulations being in effect for all periods of performance. |
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Comment:
"may have to adjust"?
| 88 | RFP, Section 4, para. 3A.i-vi, pg. 9-10 and para. 14.C.i.1 | These sections refer to minimum tests per day (28 for drive thru and 30 for non-drive thru). Given the complexities of different models and the need to manage other responsibilities (for example sample collection lockers that have a maximum capacity of 22 samples), would a lower minimum (e.g., 20 tests per day) be acceptable? | ||
| Refer to revisions in sections C.4.3.A.iv.--v. | ||||
| 89 | RFP, Section 4, para. 10.A, pg. 13 | The RFP states that swab and send PCR results will be provided to the patient within 48 hours. While we anticipate the vast majority of test results will be returned within this time period, we also anticipate it will be challenging to ensure 100% of test results are returned within this time period, particularly during times of high demand. Would 95% within 72 hours, and 75% within 48 hours be acceptable? | See revised language on page 13 (C.4.10.A) | |
| 90 | RFP, Section 4, para. 3.A.ii, pg. 10 | RFP states: ii. | "At least 50% of sites should be located in intermediate to high social vulnerability index census tract areas or, if not feasible, at least 500 sites should be located in such areas." Please confirm this means 50% of sites should be in areas with an SVI >0.25 (intermediate to high SVI). | Intermediate-to-high social vulnerability is defined as SVI >0.5. See RFP, Section 1, subsection A, Community of Interest definition. |
| 91 | RFP, Section 4, para. 5.F and 5.G, pg. 11 | RFP states: "The Contractor’s registration process shall be available and efficient for walk-up test takers" and references "paper registration." Please confirm that ability to accommodate walk-up (i.e., those without an appointment) is not required at all sites. Further, please confirm that registration via telephone call (with translation services available) is sufficient to meet this concern. Given the need for a healthcare professional to order tests, having walk-up, paper registration is not likely to be feasible depending on location type. | Walk-up is not required at all sites, only where beneficial or applicable. Offerors should propose other approaches to expedite registration where online registration may not be feasible for the government consideration. | |
| 92 | RFP, Section 4, para. 8.B, Patient testing, pg. 11 | The RFP states that the contractor shall ensure the swabbing process is overseen by a healthcare practitioner. We assume this applies only as required by the test's EUA. For example, tests approved for home collection and drop-off would not have this requirement. We suggest clarifying that this is as required by the relevant EUA. | Please see revised language C.4.8.B. | |
| 93 | RFP, Section 4. para. 4.A - G and Section 11, pgs. 10 and 14 | How will surge site locations be identified? Will Contractor be required to follow the processes and requirements set forth in Section 4, paragraph 4.A through 4.G for surge sites? | Surge sites can be the contractor, state or federal government-identified in consultation and coordination with the contractor or contractor-proposed. Refer to section C.4.4.A. | |
| 94 | RFP, Section 4, para. 15.A, pg. 16 | The RFP states "The Contractor shall submit specific specimens for further characterization (e.g., diagnostic sequencing) to state or federal laboratories as identified by the Government." What methods will be used to identify specimens of interest for further characterization? What is the process for notification? | Contractors will be notified by email to request specimens for further characterization. Specimens will be selected using existing data submitted to HHS Protect with input from state and federal government to identify which samples will be collected for further characterization. | |
| 95 | Attachment J.1, Screening Questions | If contractor has additional (non-ICATT) testing sites that bill insurance, are limited modifications, subject to CDC approval, to the screening questions permissible in order to ensure coverage issues with insurers are addressed? | Any change to the screening questions is subject to negotiation between CDC and the contractor. | |
| 96 | Attachment J.1, Screening Questions | For certain questions, the answer format is listed as “Yes/No,” though HHS Protect currently allows a third option of “Unreported.” Does “Unreported” remain an acceptable response? | Yes. | |
| 97 | Attachment J.1, Screening Questions | Screening Questions. Please confirm that updates to the vaccine-related questions to account for fourth doses for immunocompromised patients (and others, if applicable) are acceptable. | Any change to the screening questions is subject to negotiation between CDC and the contractor. Currently, data reporting requirements include the reporting of fourth doses. As vaccination approvals change, the number of doses may also change. See Attachment J.1., Section C. | |
| 98 | RFP, Section 9, para. E, Position Sensitivity Designations, pg. 23 | The RFP states "All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR)." Such background investigations are costly and very time-consuming. This requirement appears to apply solely to employees accessing government information systems. Under this contract, we understand we will be submitting reports to HHS Protect, but not accessing any government information systems. Please confirm that is consistent with the government's understanding. | See revised table on page 23. | |
| 99 | RFP, Section 9, para. E, Position Sensitivity Designations, pg. 23 | In the event any background investigation is required, please clarify who would provide the background check. Would Contractor be responsible for payment of background check costs? Please clarify the process for the background check and the Contractor's responsibilities, if any. How long do the background checks take? If background checks are delayed, what will the impact be on the start date? | See revised table on page 23. | |
| 100 | RFP, Section 9, para. F, Homeland Security Presidential Directive, pg. 23 | Please clarify what Contractor's duties would be with respect to the Homeland Security Presidential Directive? Is Contractor responsible for enforcing any requirements beyond those regarding providing and monitoring use of IDs by employees? If yes, please clarify what those additional responsibilities would include and clarify whether Contractor be responsible for any associated costs. | Since the contractor will not access any HHS or CDC network, this is not applicable. | |
| 101 | RFP, Section 9, para. F, Homeland Security Presidential Directive, pg. 23 | The RFP states "The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2." Please confirm that the stated requirements apply only to those employees who will access government information systems pursuant to this agreement (i.e., none)? | Since the contractor will not access any HHS or CDC network, this is not applicable. | |
| 102 | RFP, Section 9 para. B, Training, pg. 21 | The RFP in para. B, sections 1 and 2 requires Mandatory and Role-based training. Please clarify whether the requirement is applicable to this Agreement. Please clarify whether the requirement is applicable to employees assigned to the contract who do not have access to government systems. Please clarify whether this requirement is applicable to employees assigned to this contract who do not have access to PHI or PII. Please clarify whether Contractor will be responsible for any costs associated with the training. | Since the contractor will not access any HHS or CDC network, this training is not applicable. | |
| 103 | RFP, Section 9, para. A.2.b, pg. 18 | The RFP states "if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party." Please clarify what constitutes a "new or unanticipated threat or hazard". | New or unanticipated threats to information security such as an unanticipated data breach. | |
| 104 | RFP, Section 4, para. 3.A.vi, pg. 10 | The RFP states "For pharmacy sites, testing hours shall coincide with pharmacy hours." If the pharmacy site has met the site capacity requirement of 28 ICATT tests that day, does the requirement that testing hours coincide with pharmacy hours still apply? | Yes, per Section C.4.3.A.vi, testing hours shall coincide with pharmacy hours. | |
| 105 | RFP, Section 4, para. 8.F, pg. 12 | The RFP states "The Contractor shall provide the following test methods, as appropriate to the testing site, as proposed by the Contractor and approved by the Government at the point of site registration in HHS Protect; in limited circumstances as described 4.8.E.h, the Contract shall provide OTC tests." Please confirm that should read "the Contractor shall provide OTC tests." | Reference RFP SECTION 5 – GOVERNMENT FURNISHED MATERIALS. The Government will provide OTC COVID tests as Government Furnished Property. The Contractor shall provide unobserved self-sample collections kits. | |
| 106 | RFP, Section 4, para. 8.G, pg. 13 | The RFP states "It is the contractor’s responsibility to ensure that the tests and products purchased under this contract are TAA-compliant (see 1.A definition)." Please clarify whether this requirement applies to the individual components of the kit. | TAA-compliance is not relevant under this solicitation and reference was removed from the solicitation. | |
| 107 | RFP, Section 4, para. 12.C, pg. 14 | The RFP states "The Contractor shall perform confirmatory POC testing to confirm rapid POC-positive tests in all people and negative tests in symptomatic people." Please clarify what type of "confirmatory POC" testing is contemplated (or whether that should be confirmatory PCR testing). Also, please confirm "symptomatic" is determined by responses to screening questions. | Please refer to C.1.A definition table under "Testing Methods" and "Confirmatory Testing". |
Yes, "symptomatic" can be determined by responses to screening questions.
108 RFP, Section 4, para. 14, pg. 15 For Home Self-Collection sample, please advise whether the test used for this modality can be an over-the-counter PCR test or whether a healthcare provider’s order is required. Over-the-counter tests are acceptable.
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