Inactive

No. Question/Statement Solicitation Reference Answer/Comments 1 Is RNA sequencing a requirement? 36C10X22Q0164 RNA sequencing is preferred but not required. 2 It's mentioned that the contractor should... No. Question/Statement Solicitation Reference Answer/Comments 1 Is RNA sequencing a requirement? 36C10X22Q0164 RNA sequencing is preferred but not required. 2 It's mentioned that the contractor should, "Analyze samples and report within a turn-around time of ~2 weeks." The majority of our test are completed within 18 calendar days on average (some may be longer, e.g.: WES and WGS turnaround times are 28 calendar days on average). Is that acceptable? 36C10X22Q0164 ~ 2 weeks is the expectation for small panels and 18 calendar days would fall within that rough estimate. That said, VA's preference is as short of a turnaround time as possible for return of results. It is understandable that WES or WGS may be longer than 2 weeks. In the proposal, please specify if the laboratory can provide some test results more urgently than the 18 day turnaround and if so, would there be an additional cost associated with expedited sample processing. 3 It's mentioned that the contractor should, "Offer ordering provider created custom gene panels (ability to add/subtract genes from already curated panels) at no additional cost." Addition of genes to a panel and pricing will depend largely on the number of genes added and the difficulty involved with analyzing those genes. Often times, adding genes may not affect pricing, but there are cases in which it may. Is that acceptable? 36C10X22Q0164 Please provide examples of when adding genes to a curated panel will be feasible at no additional cost and when it will come with an added cost in the proposal. It is understandable that large additions to a custom gene panel could incur additional cost however addition or subtraction of a few genes from a panel should not incur a charge. VA will need to better understand the situations where these changes to a panel's number of genes trigger an additional charge. 4 Is it okay if a limited number of genes from the PWS Germline pricing schedule are not included? 36C10X22Q0164 It is preferred that all genes on the gene list are included. The proposal should include a comparison of vendor gene panel lists to the VA's list and highlight any differences. VA will use this information to evaluate the significance of the missing lists in our evaluation. 5 If not, is there a quality threshold on what percentage need to be included? 36C10X22Q0164 No. 6 Would a phlebotomy service be used rarely or frequently? 36C10X22Q0164 We estimate that about 15% of all test requests might benefit from a mobile phlebotomy service. 7 How often would the contractor be expected to deliver specimen kits to patient homes? 36C10X22Q0164 About 50% of orders would involve shipment of specimen kits to patient homes 8 Is it descualifying for a laboratory focused on Oncology genetic testing, not to offer the total of mandaroty tests? Specifically those that are not related to Oncology. 36C10X22Q0164 It is a mandatory requirement that test offerings span oncology and other disease areas listed in the Performance Work Statement. Oncology only test offerings would not fulfill this requirement. 9 Being this an Oncology focused program. Is it possible to remove the limitation to process samples no related to Oncology testing by an associated laboratory (not fully owned subsidiaries) and reported by the contractor ? 36C10X22Q0164 It is a mandatory requirement that test offerings span oncology and all other disease areas listed in the Performance Work Statement. 10 What percent of overlap is expected between the list genes for each example and our panels? 36C10X22Q0164 It is preferred that all genes on the gene list are included. The proposal should include a comparison of vendor gene panel lists to the VA's list and highlight any differences. VA will use this information to evaluate the significance of the missing lists in our evaluation. There is no specified overlap requirement outlined in the Performance Work Statement. 11 Is it expected that the contractor ships kits in bulk to the different VA centers or is expected that the contractor ships individual kits to patients homes on request? 36C10X22Q0164 Both are expected. The vendor will need to ship to VA facilities kits used for blood, saliva and/or buccal swab collection. The vendor will need to ship kits for saliva and/or buccal swab collection to patients' homes as well. 12 Since we are running DNA testing, the patient signature is needed, would the provider's attestation be covering the patient consent? 36C10X22Q0164 Patient signature will not typically be obtained on lab requitision form. Obtaining and documenting informed consent is a VA best practice. As such, ordering clinciians will be attesting to the patients' consent for testing. 13 When is the estimated starting date for this contract? 36C10X22Q0164 30-Sep-22 14 Is there an incumbent contractor for this solicitation? 36C10X22Q0164 No

Inactive

THIS IS A SOURCES SOUGHT (SS) ONLY. This Sources Sought is issued solely for information and planning purposes it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the futu... THIS IS A SOURCES SOUGHT (SS) ONLY. This Sources Sought is issued solely for information and planning purposes it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. This request does not commit the Government to contract for any supply or service whatsoever. Further, the Department of Veterans Affairs is not at this time seeking quotes and will not accept unsolicited quotes. Offerors are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this SS; all costs associated with responding to this SS will be solely at the interested party s expense. Not responding to this SS does not preclude participation in any future solicitation, if any is issued. **Please be brief and confine your responses to the questions asked. ** Please respond by Thursday, June 2, 2022 by 4:00 EDT. PERFORMANCE WORK STATEMENT For GERMLINE GENETIC TESTING SERVICES For DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION NATIONAL ONCOLOGY PROGRAM On behalf of the Department of Veterans Affairs (VA), the Veterans Health Administration (VHA) National Oncology Program (NOP) intends to secure specialized, comprehensive reference laboratory germline genetic testing. All services provided shall be in accordance with the costs, terms, and conditions of this contract. The contract will be administered through the VHA National Oncology Program. Contract type and term The government anticipates award of a Firm Fixed Price (FFP) Indefinite Delivery, Indefinite Quantity (IDIQ) contract. Contract use will be available to specified providers within the VA nationwide, identified through NOP. Weekly reports from the contracted laboratory are required to facilitate internal auditing performed by NOP staff or NOP designated VA employees that will ensure specified providers are ordering testing according to evidence-based guidelines or best practices, as outlined by the National Precision Oncology Program (NPOP) and for monitoring timely completion of orders and results return impacting patient care and treatment decisions. The effective period of the contract shall be from date of award through twelve (12) months with the option to extend the contract for additional 12-month periods, at the discretion of the VA, for up to two (2) additional years. Total contract will not exceed three years. Description of Services/Introduction The contractor(s) shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, trainings and other items and services necessary, as defined in the Performance Work Statement (PWS), except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract and maintain compliance with policies and procedures with the Health Insurance Portability and Accountability Act (HIPAA), the Clinical Laboratory Improvement Act (CLIA), and accreditation with the American College of Medical Genetics and Genomics (ACMG) or the College of American Pathologists (CAP) and maintain the relevant laboratory and personnel state licensure to offer testing across the United States and its territories. Objectives The objective of this request is to ensure national access to germline genetic testing for patients eligible to receive care throughout the VA enterprise in accordance with testing guidance established by the National Oncology Program (NOP) and the National Genomic Medicine Services (GMS) Program. Scope The contractor s laboratory shall have the ability to perform collection kit delivery, sample intake, processing, analysis, interpretation, and reporting for one or more germline genetic tests, as described herein. These services require a CAP- or ACMG-accredited, CLIA-certified laboratory with the ability to perform complex genetic testing (as evidenced by staff board certification and current license). Services require the ability to provide gene panels curated by the laboratory that are updated regularly with the ability to customize orders for the gene panels (e.g., add and remove genes from already curated panels) at no additional cost. Evaluation of variants of uncertain significance (VUS) through a variety of methods (e.g., RNA sequencing, family resolution studies) will be made available by the contractor s laboratory with no additional billing. Appropriateness of VUS evaluation will be determined by the ordering provider in collaboration with the contractor laboratory. Reclassification of variants (e.g., VUS, likely pathogenic, likely benign) will be performed by the laboratory including upgrading and downgrading of variants with notification to the ordering provider, associated VA laboratory and NOP to ensure all data collected both prospectively and retrospectively is up to date and consistent across delivery platforms. Testing Required The National Oncology Program seeks to contract with germline genetic testing laboratories that can receive, process, and report results for at least one or more of the test types and methodologies for the diagnostic areas as described in the Germline Genetics Price Schedule Attachment 1 to this PWS. Tests listed as mandatory must be available through the contractor and access to most preferred tests is also expected. Since the genetic testing field is dynamic, when a new type of test or test methodology is released by the contractor laboratory that is relevant to the required clinical areas, the VA will have access to that offering through a contract modification. Germline genetic test offerings and expertise are mandatory for, but not limited to the following clinical areas: cancer, cardiovascular diseases, gastrointestinal disorders, neurological disorders, endocrinology and metabolic conditions, ophthalmologic disorders, renal disorders, allergy and immunologic disorders, autoimmune and rheumatologic disorders, connective tissue and skeletal disorders, birth defects, and preconception carrier screening. Preferred areas of test offerings and expertise include chromosomal disorders, non-invasive prenatal testing, pharmacogenetics, mitochondrial disorders and polygenic risk scores. Mandatory and preferred methodologies: Mandatory methodologies: DNA-based testing such as multi-gene panels, single gene assays, and single allele assays using next generation (massively parallel) sequencing Sanger sequencing, or other methodologies. Preferred methodologies (but not limited to): DNA repeat analysis, DNA methylation analysis, RNA sequencing including quantification of gene and transcript levels, visualization, differential gene expression, alternative splicing, functional analysis, gene fusion detection, eOTL mapping, mitochondrial DNA testing, exome sequencing, genome sequencing, and chromosomal analyses and tests, such as karyotype, fluorescent in situ hybridization (FISH), and chromosomal microarrays. Description of Services The contractor must provide the following services. The proposal submitted must address each requirement below providing evidence (to the maximum extent possible) of the ability to fulfill the requirement with detailed, in-depth examples. (a) Provide the following for transport of the specimens: Laboratory test request forms customized to include information required by the VA listed below. Ordering forms must be provided in both paper based (pdf) and online ordering formats and must include: Ordering provider information (Name, address, NPI) Patient data full name date of birth social security number/MRN or a second identifier sex (biological) gender test(s) to be performed specimen collection date/time specimen type VA Station Name (patient and provider) VA Station ID (patient and provider) Special instructions for handling of specimen Description of specimen types that can be accepted for each test Specimen collection supplies for specialized testing Mailing account number to cover the costs of shipping within the US. Contractor will cover sample shipping costs. These costs are not the responsibility of or billable to the Government. (b) Sample tracking and management (e.g. utilizing bar coding) to ensure security and traceability of VA samples in accordance with good laboratory practices. (c) Analyze samples and report within a turn-around time of ~2 weeks (d) The Contractor must demonstrate capacity to service all VA Medical Centers and have a mechanism to identify tests requested specifically under this contract across VA facilities. (e) Contractor shall assume all packing and shipping costs. This includes the cost of shipment of samples from the VA Medical Centers to the Contractor as well as shipment of residual nucleic acids to NOP designated central laboratory or designee. (f) Provide an invoice for tests completed within a month of service. Vendor to provide billing contact. Invoice to include: Account number PO number Vendor ID Patient Name Patient DOB Last 4 SS# /Medical Record Number Ordering Provider Test # Test name Indication Quantity Amount Provider Institution (VA facility where provider is located) Patient Institution (VA facility where provider is located) All other information gathered as part of the test request process. Vendor will also keep NOP leadership informed about any existing contracts with VA facilities and inform leadership about incoming requests from other VA facilities for new contracts outside of the national program. (g) Provide access to a local account representative (e.g., a genetic counselor or other genetic or laboratory professional) for consultation regarding test results for VA genetics teams and interpretation by telephone and email, as needed, during regular business hours. Contractor is not expected to interact with or support direct genetic counseling or consultation for VA patients. Field team is also expected to handle issues related to sample acquisition to ensure rapid turnaround times. (h) A variant evaluation/interpretation program, which at a minimum conforms to ACMG Standards and guidelines for the interpretation of sequence variants. Such a program should include a periodic refresh of variant interpretations in light of new evidence that may increase or decrease the clinical significance of variants. The refresh should result in an updated clinical report and updated raw data and a workflow to notify NOP Staff and ordering providers of the change via the online results portal and email notification. (i) A variant resolution program that includes family studies (i.e., provides for testing of family members whose results may help inform variant reclassification) or functional studies (e.g., RNAseq) with no additional billing to VA or the patient. (j) A proficiency testing program. The VA reserves the right to request the results of any proficiency testing to which the contractor subscribes. Processes and Procedures The Contractor Laboratory shall have the following processes and procedures in place: Ensure testing is completed at the prime Contractor s facilities, to include wholly owned subsidiaries, but not subcontractor or joint venture operated sites. Ensure that samples are not further transported to any other facility for testing, nor interpreted by any other personnel than prime contractor employed, medical directors, laboratory or medical geneticists, or molecular pathologist. These professionals must be employees of the Contractor s facility or wholly owned subsidiary and be available at the site to remedy quality concerns and testing challenges. Accept and store the National Provider Identifier (NPI) for ordering providers. All are licensed healthcare providers in the VA, including genetic counselors, nurse practitioners, and physicians. Accept orders without requiring additional signed consent from patients beyond a provider s attestation on the test requisition form. Provide a list of tests currently available with a price list. Provide a secure online, user-friendly ordering portal, and the need for a VA-specific portal to support this contract will be evaluated once awarded. Portal ordering must include: Tests searchable by name and/or gene. Full list of genes for each panel must be listed online. Portal should allow for creation of customizable gene panels. Portal should automatically alert ordering providers and relevant VA staff when test results are available. Portal test ordering fields must be customizable for VA s needs The portal must have the ability to track sample status from placement of an order to a clinical report being issued and returned to the provider The portal must allow for a results search feature to query patients by patient identifiers, panel, disease, gene, and variant. The portal must allow for user-friendly download of report PDFs and search queries described above. The portal must include access controls that allow NOP system wide access to all VA orders under the contract. Ability to control user access by VA station or at the level of the individual provider is also required. Vendor must also have the ability to capture and provide audit logs when requested related to access patterns for individual users or sites. The portal must have the ability to filter orders by provider and VA site. The portal must have the ability to flag clinical reports with positive results The portal must have the ability to indicate if a previous clinical report has been updated from when it was first issued to ease review for providers assessing impact of report updates to patient care. Perform testing for VA patients for the tests requested using clinically validated tests. The Contractor shall bill only for the tests specified in the request sent by VA medical centers and ordered by authorized providers. Provide a reference test manual and report of test results, upon award, describing the full scope of its laboratory operations. Provide individual VA facilities and their respective outpatient clinics with laboratory supplies (collection tubes, postage-paid transport packaging, etc.) not customarily utilized by VA laboratories. These supplies are to be used by VA laboratories only in connection with specimens being sent for testing to the contractor. Access to a mobile phlebotomy service is preferred. Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. Provide test report electronically or by fax in an encrypted fashion compliant with VHA requirements. Ability to send raw molecular data files (e.g., BAM, BAI and VCF files) as well as final reported data files in a structured data format (e.g. report json, xml, csv, txt) is required within 3 months of contract award. Contractor must have the ability to securely perform cloud-based transfer of these files electronically to VA on a weekly basis. All data must use standard formats (and recent version) or a format acceptable to VA. Contractor to provide technical files describing the format and size of each file, including BED files. Data storage location and transfer mechanisms must comply with VA s IT security and privacy requirements. Ability to interface with the VA laboratory information system to facilitate test ordering and reporting is required within 9 months of contract award. Provide a point of contact including names and telephone number(s) to make inquiries on weekdays. Laboratory Directors, technicians, and other laboratory personnel must be made available for consultation. Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency. Ensure germline genetic test results are not released to anyone other than the ordering healthcare provider, staff/clinical team associated with the order, or NOP staff, or designees of NOP for contract management, quality improvement, IRB-approved research, or other indications. All records shall be treated as confidential, to comply with all state and federal laws regarding the confidentiality of patient s records. This provision shall survive termination of the resulting contract award. Certify and ensure that all laboratory employees, officers, or agents comply with standards set forth in the Health Insurance Portability and Accountability Act (HIPAA). The contractor must provide evidence of staff HIPAA training compliance. Prepare weekly (running, contract to date) and monthly (single month summary) reports that provide information to the VA regarding genetic test orders and results at the patient and test level. Reporting requirements include but are not limited to: Patient first and last name Patient MRN or SS# Patient Date of Birth Vendor assigned Requisition Number Patient VA facility name and station number Medical record number Ordering provider name and NPI Specimen type Date of specimen collection Date of test result report Order status and associated dates with current order status indicated Test name Indication of reflex testing (when applicable), Procedure/test type Genes names included in panel and associated CPT codes IDC-10 codes Report release date Summary of results (weekly) Monthly results will expand on above to include structured breakdown of results from clinical report (to be discussed more upon award to span all eligible test types covered in this contract) Weekly reports shall be available no later than 3 days after the end of the week. Monthly reports shall be available within 15 days after the end of each month. These reports should be submitted in Microsoft Excel or similar format. Prepare an annual report that summarizes germline genetic test utilization and costs overall and by ordering provider and VA facility. Test Sample Preparation VA laboratories shall be responsible to provide laboratory specimens prepared in accordance with the contractor s Laboratory User s Manual. All specimens will be properly identified and labeled for testing to include at least two identifiers (e.g., patient name, medical record number, date of birth). The contractor shall provide an adequate supply of requisition forms, special instructions, and a current list of tests with specimen requirements. These requirements shall be defined in the laboratory user s manual. Transport of Specimens The contractor laboratory client Services will provide a mailing account number to send specimens directly to the contractor s laboratory. The contractor laboratory must have the ability to send saliva kits and/or buccal swab kits directly to a patient s home and provide packaging/mailing supplies for the patient to send a specimen directly back to the contractor laboratory. The contractor laboratory will not use patient address for any other purpose beyond mailing specimen collection supplies. Access to a mobile phlebotomy service is preferred. Reporting of Test Results A clinical report is defined as a printed final copy of a genetic test result interpreted by individuals with training in genetics and signed out by a ABMGG board-certified geneticist or molecular genetic pathologist. Consult reports shall be sent by contractor electronically or by fax to the ordering provider, VA laboratory and made available to NOP staff in batch for all orders placed under this contract. Each clinical report shall, at a minimum, indicate the following information: Patient s full name Patient s date of birth Patient s unique medical record number Patient s VA Station and Station ID Ordering provider s name Ordering provider s NPI Purchase order account number (e) Test(s) ordered, including list of genes analyzed (f) Date/time of specimen collection (when available) (g) Date/time specimen received in Reference Lab (h) Date test signed and reported (i) Type of specimen/source (j) Test result(s) (k) Flag abnormal results (l) Comments on interpretation for variants of uncertain significance, likely pathogenic, and pathogenic results, which may include but are not limited to: Clinical summary, comments on familial testing, variant effect on protein, ClinVar entries, in silico models, experimental studies, reference to population databases. (m) Methodology used and limitations of listed methodology (n) Name of testing laboratory (contractor and/or wholly owned subsidiary), address, CLIA number (o) Testing laboratory specimen number (p) Information that may indicate a questionable validity of test result (q) Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing Evidence of the ability to fulfill this requirement must be demonstrated in the proposal by providing example illustrative reports. Reporting of Raw Data In addition to performing and returning clinical test result reports (as outlined above), all raw and finished data generated as a result of testing including (but not limited to) FASTQ, BAM, VCF, PDF, and structured results (XML, JSON, or .txt files) shall be delivered to the National Oncology Program Office. Once award is made, the method of delivery will be determined in conjunction with the Government and the awardee. Since the genetic molecular testing field is dynamic, when a new type of test or test methodology is released that is relevant to the required clinical areas and is not currently on the schedule, the parties maintain the option to add it to the contract by mutual agreement. In addition to clinically validated test results, the VA also has interest in any research use only data generated. This must 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. Training and Education Contractor will work closely with NOP and GMS leadership to develop a comprehensive training and education program to include live/recorded sessions and supporting materials covering the following topics: How to place an order with paper Requisition forms How to use of the Online Portal for placing orders and viewing results Laboratory Set up for interfacing with contractor to include specimen retrieval and shipment Test Offering medical/scientific education and results interpretation from Clinical reports Test and Report Updates when applicable This plan and associated content should be distributed to VA sites and providers initially and also throughout the course of the contract (as needed). This program and its distribution is also expected to remain up to date as content or processes evolve during testing implementation. Licensing and accreditation Contractor Laboratory shall: Have all licenses, permits, accreditation certificates required by Federal law and State law. Maintain Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) certification and accreditation by the College of American Pathologists (CAP) or the American College of Medical Genetics and Genomics (ACMG). 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 Molecular Genetics qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA, ACMG and CAP standards. Have personnel assigned to perform the services covered by the contract who are eligible to provide these services and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on the contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board. Comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS). Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention. Notify the Contracting Officer immediately, in writing, upon its loss (or any of its subsidiaries) of any required certification, accreditation, or licensure. Upon award, provide an electronic Laboratory Manual containing: Department hours of operation Accreditation Technical Staff Service Departments (Method of contacting, phone numbers, hours of availability) Quality Control and Quality Assurance Information Billing Procedures & fee schedules for services provided Procedures and criteria for phoning reports and other important information Contract Performance Monitoring: Quality Control: The contractor shall operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with the PWS. The quality control program shall include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s quality control program is the means by which the contractor laboratory assures that work complies with the requirement of the contract. A Quality Assurance and Monitoring Plan will be established between NOP and the contractor within the first 6 months of contract award to include at a minimum bi-annual review of metrics including but not limited to: testing turnaround time, reflex test tracking, low quality/insufficient sample tracking, and monitoring severity and response time to resolve any provider identified clinical issues. The contractor s facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the National Oncology Program during the life of the contract. Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission, and regulations required for performing the type of services described herein and provide that quality assurance plan. The government shall evaluate the contractor s performance under the contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). Hours of Operation: The contractor is responsible for providing services 8:00am 5:00pm Monday Friday, local time, except for Federal Holidays. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within the PWS. When hiring personnel, the Contractor shall hire in a manner congruent with the established stability and continuity of the workforce. Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property provided to the contractor laboratory. Contractor Furnished Items and Responsibilities: The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work as outlined in this contract. Periodic reporting. Provide at least four quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to national Oncology Program Staff, identified at the time of contract award. The reports shall be in Microsoft excel format and include at minimum the following for each test ordered: patient name, patient medical record number, ordering provider, ordering provider NPI, date of specimen collection, date of results report, test name, test procedure and relevant CPT codes. In addition, a summary report should include volume of testing for each test type, cost per test, total cost, and median days (with range) for test turnaround from accessioning to reporting date. These reports shall be available within 30 days after the end of each quarter. Summary of Key Deliverables: Offer all mandatory tests and at least 75% of preferred tests as described in the Germline Genetics Price Schedule. Gene lists for panels must comply with required genes according to ACMG, ESMO and other published standards for germline genetic testing. Preferred genes within panels are indicated in the Germline Genetics Price Schedule. The proposal must include reference to how well vendor gene lists overlap with those described in the Schedule. Offer ordering provider created custom gene panels (ability to add/subtract genes from already curated panels) at no additional cost. Have the ability to reflex to a larger panel of genes associated with phenotype at no additional cost. Provide site specific mutation testing utilizing a previous family member s test. Provide evidence of current CAP/CLIA accreditation with certificates. Offer testing and interpretation on site or at wholly own subsidiaries Provide ordering fields and an online portal customizable to VA s needs as described in the PWS. Provide sample reports in line with the requirements described in the PWS. Examples should include: BRCA2 pathogenic BRCA2 VUS Breast cancer panel negative TP53 low mutant allele fraction APC p.I1307K RAD50 pathogenic TTN likely pathogenic Provide evidence of appropriate Medical Director qualifications as described in PWS. Provide documentation addressing how the testing facility, processes and methodologies meet the requirements described in the PWS. Provide access to a field team to support testing and results interpretation. Provide access to a medical affairs function for provider education in partnership with the National Oncology and Genomic Medicine program. Provide evidence of ability to meet VA s reporting requirements described in the PWS. Provide evidence of ability to transfer raw data generated from genetic testing to VA through secure delivery mechanisms as described in the PWS. Provide a weekly summary report that provides information to the VA regarding test orders, order status, sample status and results at the test level. Provide monthly data reports that build from the weekly data reports to also include structured results data extracted from clinical results reports. Monthly utilization/cost reports and an annual report (for contract performance period) to the national Oncology Program. Establish a Quality Assurance and Monitoring Plan as outlined in the PWS. Establish a Training and Education Program to be implemented in collaboration with NOP leadership and staff as outlined above in support of providers using and ordering testing. Please respond by Thursday, June 2, 2022 by 4:00 EDT. **Please be brief and confine your responses to the questions asked. ** Business size: SERVICE-DISABLED VETERAN OWNED SMALL BUSINESS (SDVOSB) VETERAN OWNED SMALL BUSINESS (VOSB) SMALL BUSINESS (SB) LARGE OTHER Provide a brief statement of core business competencies. Do you have three or more years expertise and or experience providing the same or similar services? Do you have a General Services Administration (GSA) schedule offering the required services? Brief summary of why your organization is the best fit to meet the requirements outlined in the PWS. In the event a solicitation is issued, how likely are you to submit a response?