MRDT Questions Compiled as of Amendment 0001 final.xlsx
XLSX spreadsheet 20 KB Posted
- Solicitation number
- 36C10G22R0020
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Other files
| File | Type | Posted |
|---|---|---|
| Attachment 8 Technical Evaluation Matrix as of Amendment 0001.xlsx | XLSX spreadsheet | |
| Attachment 3 - Excel Price-Cost Schedule as of Amendment 0001.xlsx | XLSX spreadsheet | |
| 36C10G22R0020 0001.docx | DOCX document | |
| Attachment 6- Question Submission Format.xlsx | XLSX spreadsheet | |
| Attachment 3 - Excel Price-Cost Schedule.xlsx | XLSX spreadsheet | |
| Attachment 7 - Past Performance Questionnaire.docx | DOCX document | |
| Attachment 8 Technical Evaluation Matrix.xlsx | XLSX spreadsheet | |
| 36C10G22R0020_2.docx | DOCX document | |
| Attachment 1 - Invoice Inquiry Tracker.xlsx | XLSX spreadsheet | |
| Attachment 4 - Pay.gov Vendor Submittal Instructions.docx | DOCX document | |
| Attachment 5 - HIPAA-Business Associate Agreement.docx | DOCX document | |
| Attachment 2 Contractor Discrepancy Report.pdf |
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Sheet1
| Page No. | Section Number | Question | ||||
| 1 | 19 | 6 | "Provide evidence of appropriate Medical Director qualifications as described in the Constraints section. Constraints Section states: Maintain Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) certification and accreditation by the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer to include the contractor laboratory’s Laboratory Director(s) and/or Medical Director(s). | |||
| Medical Director(s) shall have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA, CAP and NY State Department of Health standards." QUESTION: The qualification for a laboratory director of high complexity testing at 42 CFR 493.1443(b)(3)(i) is that the laboratory director must hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS. A medical director is required for pathology testing, a staff medical director is not required for high complexity genetic testing. All laboratory licensure falls under our Lab director to meet qualifications. If the testing doesn't require a medical director for licensure will our licensure under the PhD Lab Director suffice? | PhD lab director qualifications are acceptable as long as they are in line with CAP/CLIA requirements for high complexity testing as described here: https://documents.cap.org/documents/CAP-personnel-requirements-by-test-complexity.pdf | |||||
| 2 | 18 | Constraints | QUESTION: NY State Clinical Lab Permit expires/renews for all permitted labs on June 30th 2022. The new NY State Permit is expected to be issued to labs that are in good standing and have fufilled all renewal requirements around the time of the expiration June 30, 2022 (within a week of expiration). In the event the permit is not sent from NY State prior to submission will this be awarded based on past NY state certifications that are active until 6/30/22 along with proof of running samples in NY State with the expectations the 2022-2023 permit is sent to the CO as soon as NY state issues? | Yes, this is acceptable | ||
| 3 | 16 | viii & xi | QUESTION: VA Facility ID and VA Station ID. Can this be in the same field as clinic name example: VA Health Facility ## Station XXX or has this already been assigned and requires an individual field? | These are existing and established VA specific identifiers that must be accommodated as described in the SOO. The station ID is a 3-6 digit number that uniquely identifies each facility that may order testing. It is accompanied by a VA Station Name. Both are separate fields. | ||
| 4 | 17 | Objective 4 | "The proposal must demonstrate contractor’s ability to send raw molecular data files (e.g., FASTQ, BAM, BAI and VCF files) generated as a result of the testing process as well as final reported data files in NPOP specified structured data formats (report json, xml, csv, txt) within 3 months of contract award. Additionally, patient results in aggregate (at a weekly frequency) with patient and test identifiers, individual variant results with associated annotations that represent the final reported results shall be delivered to the National Oncology Program in excel/csv formats that are compatible with and can be easily loaded into SQL tables. These data files are to be provided to NPOP rather than individual VA facilities or providers. In addition to clinically validated test results, NPOP also has interest in any research use only data generated by the contractor. This should be provided separate from the clinical results, ideally as raw data in structured or semi-structured formats as well as through data visualization tools via an online portal or similar interactive system." | |||
| QUESTION: Tumor informed MRD tests do not report invidual somatic variants from the tumor sequencing or the plasma ctDNA that are clinically annotated in the manner that comprehensive genomic profilling (CGP) does. Does the government expect to receive individual variant information that is not on the clinical report? | If individual variants are not generated or reported as part of the assay, raw data on individual variants will not be required. Based on demonstrations at VA industry day, some testing technologies do report out individual variants on the ctDNA report and also generate individual variant data from the initial tissue sequencing intended to identify mutations that will be tracked. When this is generated by the contractor, the data should be provided to VA, even if it is intended for research use only (RUO) and is not clinically reported. The raw files provided to the VA will be in accordance with what the assay generates. Clinical reports must always be provided in structured formats for incorporation into VA databases in addition to typical PDFs issued to the provider. Data provided should clearly specify what is clinically validated and reportable and what is intended for research use only. | |||||
| 5 | 18 | 3 months | First paragraph "within 3 months of contract award" QUESTION: Does this mean that no test will be ordered in the first 3 months of the contract? Is this 3 month period to be seen as an implementation period to aligning the portal? | This is intended to provide some time for implementation. | ||
| 6 | 17 | a | "Portal should automatically alert providers and relevant VA staff when test results are available." QUESTION: With 130 medical centers and numerous users how will the data alerts be provided? Will a list be given or does each end-user need to register? | Typically portals will have individual user accounts for VA personnel responsible for placing orders and viewing results. The intent of this requirement is that users associated with these accounts should receive notification of results via email if they are associated with a particular order. | ||
| 7 | 16 | Objective 3 | "Laboratory test request forms and any online order mechanism must be customized to include information required by the VA listed below. These fields should also be available on the final clinical report. Ordering forms must be provided in both paper based and online ordering formats and must at a minimum include: Page 20 Bullet #4 Provide ordering fields and an online portal customizable to VA’s needs as described in the SOO." QUESTION: How will the online order mechanism be evaluated? Does a mock need to be provided with the proposal or will just a printout of the fields be accepted (per page 20)? Will there be a period of time after award for the teams to work together to define the system requirements to align with the government needs? | Please provide screenshots and/or list the currently available fields in the online portal. If all required fields are currently not available, the proposal must outline a plan with a specific timeline to be able to meet the specified requirements upon award. | ||
| 8 | 18 | 2nd paragraph | "VA cloud electronically" QUESTION: Are there specifications for the system that the data will be sent to? Are there any barriers to this system interacting with standard commercial systems? | VA typically stores this data in an AWS S3 bucket. | ||
| 9 | 18 | 3rd paragraph | "Additionally, the vendor must also have the ability to interface with the VA’s electronic health record systems (Vista CPRS and Cerner)" QUESTION: Where are the specifications on how to interact with these systems? | Specifications to be determined upon contract award. VA is looking for a vendor that is amenable to providing this integration and should indicate this in the proposal. Previous integration experience with the EHRs listed or others should be outlined in the proposal. | ||
| 10 | 52 | Subfactor 1 | "Offerors shall provide a Statement of Objective (SOO) in response to the Statement of Objectives and this RFP." | |||
| QUESTION: Are you looking for a SOO or a proposal in response to the SOO? | VA is looking for a proposal from contractors in response to the requirements outlined in the SOO. | |||||
| 11 | QUESTION: How will orders be received? I do not see mention of ordering officers. It would appear that a Task Order would need to issued and signed for each order? Is this the expectation? If so, would each order be added to the tracking report upon signature? | Individual VA providers and laboratories will be provided access to the vendor's ordering portal or paper requisitions to be able to independently place orders. The National Oncology Program will establish a fully funded Task Order against the base contract that will fund the max number of tests. The contract awardee will invoice the program office on a monthly for the total number of tests completed that month. The orders placed under the contract will be centrally billed to the National Oncology Program. There will need to be a mechanism (e.g. PO number) for orders to be identified as having been placed under the contract and billable to the National Oncology Program. | ||||
| 12 | Pricing | Att 3 | QUESTION: MRD tests are ordered in a serial fashion with patients on average submitting 2-3 blood samples annually, with pricing being established per sample not per patient. Are the estimated volumes of 800 in the base year and 1120 in the option year 1 the number of estimated samples submitted each year or the number of patients expected to be assed using tumor informed MRD with each patient submitting multiple samples? | Number of patients | ||
| 13 | 14 | 3rd paragrah | QUESTION: In Objective 1 the stated applications for use of a tumor informed MRD test cover a broad range of indications that will have differing considerations for sampling frequency. Can the government provide more detail on the primary cancer types and applications for use of the tumor informed MRD test? Can the government provide respondents access to the VACCR for the purpose of modeling & proposing potential usage and volume? | Unfortunately, access to the VACCR cannot be provided as part of the acquisition process. The contractor should submit the clinically validated uses and tumor types of their test(s) along with the associated sampling frequency for each tumor type. | ||
| 14 | 18 | c | "The Contractor must provide specifically demonstrated history of testing samples from patients in New York State for each test included in the proposal. " QUESTION: What format and data is expected to show history of testing samples in NY State? | A list of customers with patients in NY State for which testing has been provided should be included in the proposal. If approximate testing volume can be shared, that is also beneficial to demonstrate compliance with this requirement. | ||
| 15 | 56 | A | QUESTION: Are we limited and required to stay under the max awarded amount? | No | ||
| 16 | 16 | Objective 3 | "The portal must allow for a clinical results search feature to query patients by patient identifiers, panel, disease, gene and variant." QUESTION: Tumor informed MRD tests do not report invidual somatic variants from the tumor sequencing or the plasma ctDNA that are clinically annotated in the manner that comprehensive genomic profilling (CGP) does. Does the government expect to receive individual variant information that is not on the clinical report? | The portal must be searchable for results that are within the clinical report. If individual variants are not reported, the gene and variant search feature is not required. | ||
| 17 | 10 | B.4 | QUESTION: Currently there are no tumor informed MRD tests that have been approved in accordance with the pre-market notification under the Food and Drug Administration (FDA) process. Does the government expect current or future tumor informed MRD tests to be FDA approved prior to implamentation? | FDA approval is not required. The referenced FDA document lists best practices for the development of tests using this technology. A demonstration of how well the tests align with the recommendations should be provided in the proposal. | ||
| 18 | 18 | 1st Paragraph | "NPOP also has interest in any research use only data generated by the contractor." QUESTION: Tumor informed MRD tests do not report invidual somatic variants from the tumor sequencing or the plasma ctDNA that are clinically annotated in the manner that comprehensive genomic profilling (CGP) does. Does the goverment expect to recieve individual variant information that is not on the clinical report? Is ther specific infomation being sought? | If individual variants are not generated or reported as part of the assay, raw data on individual variants is not required. Based on demonstrations at VA industry day, some testing technologies do report out individual variants on the ctDNA report and also generate individual variant data from the initial tissue sequencing intended to identify mutations that will be tracked. When this is generated by the contractor, the data should be provided to VA, even if it is intended for research use only (RUO) and is not clinically reported. The raw files provided to the VA will be in accordance with what the assay generates. Clinical reports must always be provided in structured formats for incorporation into VA databases in addition to typical PDFs issued to the provider. Data provided should clearly specify what is clinically validated and reportable and what is intended for research use only. | ||
| 19 | Tech. Eval. Matrix | "The Contractor is validated to perform Minimal Residual Diease Testing Services for the National Cancer Institute – Molecular Analysis for Therapy Choice (NCI-MATCH) study at the time of contract award" QUESTION: NCI-MATCH studies do not currently utilize tumor informed MRD testing for patient enrolement. No tumor informed MRD testing lab will meet this requirement. Can the requirement be changed to other NCI or co-opertive group studies that do utilize tumor informed MRD testing? | The attachment has been amended. See amended Attachment 8. | |||
| 20 | 18 | Confidentiality | "The Contractor will be required to sign a Business Associate Agreement." QUESTION: Commercial labs are HIPPA-covered entities as is the VA Health System and providers. Two HIPPA covered entities working together do not require a BAA unlike working with a non HIPPA Covered entity/business associate. Is a HIPPA-covered entity required to complete a BAA ? | Typically, the VA has entered into a BAA with molecular testing providers, regardless of status as HIPPA covered status. | ||
| 21 | Attachment 3 | Under estimated quantity, is this estimated number of patients, or estimated number of tests? Our assay is built upon an initial test that is customized to the patient, with follow-on tests at intervals specified by the clinician. Could you clarify how many initial tests and follow on tests would be requested? | This is estimated number of patients. In the proposal, the contractor should specify how many tests this would correspond to based on the sampling frequency recommended for each tumor type for which the test is clinically validated. | |||
| 22 | 12 | Obejective 1 | Are color graphs permitted? We utilize them to demonstrate sensitivity and specificity across experiments for our validation. In black and white they are not a logical demonstration. | Color graphs are permitted. | ||
| 13 | Objective 2 | Can you help us understand if this solicitation covers only MRD (Minimal Residual Disease testing in Early-Stage cancer) or also TRM (Therapy Response Monitoring in late stage, stage IV metastatic cancer)? Is the VA seeking more than one test for this solicitation award? | As specified in the Statement of Objectives (SOO), both applications of MRD are within scope for this RFP. The contractor's proposal should include tests that cover one or both of these applications. | |||
| 10 | B.5 PRICE/COST SCHEDULE | In the Price/Cost schedule MRD is listed as a single line-item price. How would the base test be factored in this schedule if there is an opt-in on MRD? | The attachment has been amended. See amended Attachment 3. | |||
| 9 | If no vendors meet the minimum requirements set forth in the solicitation, how will the VA proceed? | If no respondents meets the minimum requirements the VA will reevaluate the acquisition strategy | ||||
| 1 | Standard Form 1449 | Can you share what the anticipated award date or effective contract date will be? Then related to the award date, what is the VA’s anticipated implementation period for MRD? | The Government anticipates award NLT September 30, 2022. VA expects to utilization of testing is expected within the first month of award. | |||
| 15 | Objective 4: Structured data return to VA | What is the expectation for data use rights between VA and contractor with respect to data generated in connection with the performance of the contract, including but not limited to structured data (outlined in objective 4)? | Data generated from testing of VA patients is not to be utilized by the contractor (e.g, for product development, monetizing with other industry partners) except for the sole purpose of providing clinical testing services and meeting VA's reporting requirements as outlined in the Statement of Objectives. VA retains full rights to this patient data and it's use in alignment with VA goals and objectives. | |||
| 13 | Objective 2 | Can you describe with more specificity what type of clinical utility the VA wants to see? Would there be value in seeing the decision impact of the test result? | The decision impact of the test with respect to patient management should be included in the proposal. | |||
| 9 | B.4 | Pre-market notification can include 510k clearance? | FDA approval/clearance is not a requirement. The FDA guidance provided in the Statement of Objectives is intended to highlight how contractor's assays align with best practices as specified by the FDA and other professional organizations such as AMP. | |||
| 12 | Objective 1 | Are there priority tumor types for the VA? | Please include all tumor types for which the test is clinically validated in the proposal. VA is interested in understanding the breadth of tumor types covered by contractors test(s). | |||
| 15 | Objective 4 | Are raw molecular data files required for both the tissue sequencing and the ctDNA sequencing components of the test? | Yes | |||
| 16 | Constraints | New to market tests may not have a long history of testing of NY state patients. Is a testing history for a new test that is a modification of an existing test with a history of testing NY state patients acceptable? | Yes, that is acceptable | |||
| 16 | Constraints | Can you specify the permits and accreditations that are required? Is the New York State Department of Health a requirement? | Current CAP/CLIA accreditation with certificates and NY State Department of Health approval for each test is required. | |||
| 1 | ATTACHMENT 8 - TECHNICAL EVALUATION MATRIX | There is a reference to Minimal Residual Disease Testing Services for the National Cancer Institute – Molecular Analysis for Therapy Choice (NCI-MATCH) study in the technical evaluation, is the VA seeking to understand if the vendor is a designated commercial lab for NCI? | The attachment has been amended. See amended Attachment 8. | |||
| 9 | B.4 | Is FDA approval a requirement for this solicitation award? | FDA approval is not a requirement | |||
| Can you tell me approximately when the VA intends to start the project? Specifically, when might the VA start shipping samples to the selected vendor(s)? Would this be in 2023? If so, when? | VA expects to utilize the test in Q4 calendar year 2022. Contractor should be capable of receiving orders from the VA at the time of contract award. |
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