36C10X22Q0164_2.docx

SUBJECT*

Germline Genetic Lab Testing Services_VHA_National Oncology Program

GENERAL INFORMATION

SET-ASIDE

Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

POINT OF CONTACT*

Brian.Ballard@va.gov Wanda.Edwards@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

GERMLINE GENETIC TESTING SERVICES

For

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

NATIONAL ONCOLOGY PROGRAM

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

1. GENERAL INFORMATION

Contracting Office Address Strategic Acquisition Center—Frederick (SAC-F) Department of Veterans Affairs 5202 President’s Court, Suite 103 Frederick, MD 21703

Description

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; “quotations” are being requested, and a written solicitation document will not be issued.

(ii) This solicitation is a request for quotations (RFQ) 36C10X22Q0164.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2022-06.

(iv) Germline Genetic Testing Services

(v) This first page is to be removed upon award and replaced with a SF1449 and table of contents.

Questions are due by 10 A.M. EDT, August 10, 2022. Any questions received after this date may not be answered.

Name and contact information for information regarding the solicitation:

Wanda Y. Edwards, Contracting Officer, Department of Veterans Affairs, SAC-F, Wanda.Edwards@va.gov and Brian Ballard, Contract Specialist at Brian.Ballard@va.gov

All interested companies shall provide quotations for the following:

36C10X22Q0164

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SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT:

Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703

Contracting Officer (CO): Wanda Y. Edwards Wanda.Edwards@va.gov

Contract Specialist (CS): Brian Ballard Brian.Ballard@va.gov

Contracting Officer Representative (COR) – will be appointed under separate document (COR Delegation letter)

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 INVOICING INSTRUCTIONS

1. Submission - In accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests, all invoices shall be submitted electronically. A copy of all invoices shall be provided to the contracting POC identified in section B.1.

Tungsten (fka OB10) ELECTRONIC INVOICE SUBMISSION FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Vendor Electronic Invoice Submission Methods:

Fax, email and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted data transmissions below.

· VA’s Electronic Invoice Presentment and Payment System – The Financial Services Center (FSC) in Austin, TX uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

· A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site is http://www.x12.org.

Vendor e-invoice Set-up information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center in Austin, TX for payment processing. If you have questions about the payment status of a properly submitted invoice, the e-invoicing program, or Tungsten, please contact the FSC at the phone number or email address listed below.

· Tungsten e-Invoice setup information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@tungsten-network.com

· FSC e-Invoice contact information: 1-877-353-9791

· FSC e-Invoice email: vafsccshd@va.gov

· http://www.fsc.va.gov/einvoice.asp

COMMUNICATIONS:

· https://www.federalregister.gov/articles/2012/11/27/2012-28612/va-acquisition-regulation-electronic-submission-of-payment-requests

· http://fcw.com/articles/2012/11/27/va-epayments.aspx?s=fcwdaily

1. Submission of Proper Invoice - The following data must be included in an invoice for it to constitute a proper invoice:

a. Name and address of the contract

b. Invoice date and number

c. IFCAP Purchase Order No.: TBD

d. Contract No. TBD

e. Item number, description, quantity, unit of measure, price, extended price and a total of supplies delivered, or services performed.

1. Cumulative billing (per line item and total)

1. Final invoices must be marked ‘FINAL INVOICE’

1. Proof of supplies delivered, or services performed MUST also be provided. Signature, printed name, and title of Government receiving official, and date of delivery or performance period must be included.

INVOICES THAT DO NOT COMPLY WITH THESE REQUIREMENTS SHALL BE REJECTED.

3. Contractor Remittance Address: All payments by the Government to the contractor will be made in accordance with:

4. Invoices: Invoices shall be submitted in arrears:

36C10X22Q0164

5. Government Invoice Address: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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B.3 PERFORMANCE WORK STATEMENT

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 VHA National Oncology Program (NOP) intends to secure specialized, comprehensive reference laboratory germline genetic testing. The contract will be administered through the VHA National Oncology Program.

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 Program.

DESCRIPTION OF SERVICES/INTRODUCTION

The contractor 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.

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 in accordance with national guidelines and 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 the clinical significance of variants with notification to the ordering provider, associated VA laboratory and NOP to ensure all clinical and raw 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. Tests listed as mandatory shall 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 (include but are 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 shall provide the following services. The proposal submitted must address each requirement below providing evidence (to the extent possible) of the ability to fulfill the requirement with examples included in the proposal.

(a) Provide the following for transport of the specimens:

1. 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:

a. Ordering provider information (Name, address, NPI)

b. Patient data

i. full name

ii. date of birth

iii. social security number/MRN or a second identifier

iv. sex (biological)

v. gender

vi. test(s) to be performed

vii. specimen collection date/time

viii. specimen type

ix. VA Station Name (patient and provider)

x. VA Station ID (patient and provider)

xi. diagnosis

xii. ICD-10 code

2. Special instructions for collection and handling of specimen

3. Description of specimen types that can be accepted for each test

4. Specimen collection supplies for specialized testing

5. 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) Overall order status tracking to allow for tracking orders from the time they are placed to completed. This will also include tracking for failed orders and in those instances provide reason for failure (ex: tissue insufficient).

(e) The Contractor must demonstrate capacity to service all VA Medical Centers (approximately 170) and have a mechanism to identify tests requested specifically under this contract across VA facilities.

(f) 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.

(g) Provide an invoice for tests completed within a month of service. Contractor to provide billing contact. Invoice shall 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.

· Contractor 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.

(h) 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.

(i) 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 shall result in an updated clinical report and updated raw data and a workflow to notify NOP Staff (prior to implementation) and ordering providers in real time of the change via the online results portal and email notification. Use of thie variant interpretation program will apply to all retrospective and prospective data collected under this contract.

(j) 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.

(k) 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:

(a) Ensure testing is completed at the prime Contractor’s facilities, to include wholly owned subsidiaries. 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.

(b) 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.

(c) Accept orders without requiring additional signed consent from patients beyond a provider’s attestation on the test requisition form.

(d) Provide a list of tests currently available with a price list.

(e) 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 and organizational structure, allowing for providers to place orders and review results at multiple sites, VISN level or nationally as needed. 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 and by provider or facility

· 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.

· The portal must have the ability to store care team information so results can be shared with appropriate individuals.

(f) Work with NPOP for portal account set up only with approved providers as identified by NPOP.

(g) 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.

(h) Provide a reference test manual and report of test results, upon award, describing the full scope of its laboratory operations.

(i) 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.

(j) Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.

(k) Provide test report electronically or by fax in an encrypted fashion compliant with HIPAA requirements.

(l) Ability to send raw molecular data files (e.g., FASTQ, 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. 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 that are based on NIST standards.

(m) Ability to interface with the VA laboratory information system to facilitate test ordering and reporting is required within 9 months of contract award.

(n) 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.

(o) 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.

(p) 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.

(q) 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.

(r) Prepare weekly and monthly reports that provide information to the VA regarding genetic test orders and results at the patient and test level.. Weekly reports should include contract to date raw data at the patient level and incorporate all updates and amendments as the data matures. Monthly reports should include a single month’s data for all completed testing (both raw and summary level) Reporting requirements for both weekly and monthly data include but are not limited to:

· Patient first and last name

· Patient MRN or SS#

· Patient Date of Birth

· Vendor assigned Requisition Number

· Vendor Billing / Account code

· 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

· Diagnosis

· Stage (for patients with cancer)

· Report release date

· Summary of results (weekly) Monthly reports will expand on above to include a structured breakdown of results from the validated 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 business days after the end of the week. Monthly reports shall be available within 15 calendar days after the end of each month. These reports should be submitted in Microsoft Excel or similar format.

(s) Prepare an annual report that summarizes germline genetic test utilization and costs overall and by ordering provider and VA facility.

NPOP will generate and provide the contractor with regular lists of approved providers who can then place orders upon contract award. NPOP will oversee development and communication on guidelines outlining when testing is appropriate for ordering per evidence-based guidelines. Weekly reports from the contracted laboratory as outlined above are required to facilitate an auditing of both providers and test types to ensure 1.) only approved providers place orders and 2.) that tests ordered follow our programmatic guidelines for patient eligibility. This will be performed by NOP staff or NOP designated VA employees again to ensure specified providers are ordering testing according to evidence-based guidelines or best practices, as outlined by the National Precision Oncology Program (NPOP).

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:

(a) Patient’s full name

(b) Patient’s date of birth

(c) Patient’s unique medical record number

(d) Patient’s VA Station and Station ID

(e) Ordering provider’s name

(f) Ordering provider’s NPI

(g) Purchase order/ billing/ account number

(h) Test(s) ordered, including list of genes analyzed

(l) Type of specimen/source

(m) Test result(s)

(n) Flag abnormal results

(o) 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.

(p) Flag and date for any associated amendments

(q) Methodology used and limitations of listed methodology

(r) Name of testing laboratory (contractor and/or wholly owned subsidiary), address, CLIA number

(s) Testing laboratory specimen number

(t) Information that may indicate a questionable validity of test result

(u) 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 FASTQ, BAM, VCF, PDF, and structured results (XML, JSON, csv or .txt files) shall be delivered to the National Oncology Program Office. 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. 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 the form of a contract modification. In addition to clinically validated test results, the VA also has interest in any research use only (RUO) data generated as a result of the testing performed on VA specimens. 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 The Contractor will work closely with NOP 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:

(a) Have all licenses, permits, accreditation certificates required by Federal law and State law.

(b) 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 Representative (COR) 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.

(c) 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 and 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.

(d) Comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS).

(e) 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.

(f) Notify the Contracting Officer and the COR 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:

(a) Department hours of operation

(b) Accreditation

(c) Technical Staff

(d) Service Departments (Method of contacting, phone numbers, hours of availability)

(e) Quality Control and Quality Assurance Information

(f) Billing Procedures & fee schedules for services provided

(g) 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 requirements 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 8:00 a.m. – 5:00 p.m. 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.

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 calendar days after the end of each quarter.

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Summary of Key Deliverables:

1. 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 contractor gene lists overlap with those described in the Schedule.

2. Offer ordering provider created custom gene panels (ability to add/subtract genes from already curated panels) at no additional cost.

3. Have the ability to reflex to a larger panel of genes associated with phenotype at no additional cost.

4. Provide site specific mutation testing utilizing a previous family member’s test.

5. Provide evidence of current CAP/CLIA accreditation with certificates.

6. Offer testing and interpretation on site or at wholly own subsidiaries

7. Provide ordering fields and an online portal customizable to VA’s needs as described in the PWS.

8. Provide sample reports in line with the requirements described in the PWS. Examples should include:

8.1. BRCA2 pathogenic

8.2. BRCA2 VUS

8.3. Breast cancer panel negative

8.4. TP53 low mutant allele fraction

8.5. APC p.I1307K

8.6. RAD50 pathogenic

8.7. TTN likely pathogenic

9. Provide evidence of appropriate Medical Director qualifications as described in PWS.

10. Provide documentation addressing how the testing facility, processes and methodologies meet the requirements described in the PWS.

11. Provide access to a field team to support testing and results interpretation.

12. Provide access to a medical affairs function for provider education in partnership with the National Oncology and Genomic Medicine program.

13. Provide evidence of ability to meet VA’s reporting requirements described in the PWS.

14. Provide evidence of ability to transfer raw data generated from genetic testing to VA through secure delivery mechanisms as described in the PWS.

15. Provide a weekly summary report that provides information to the VA regarding test orders, order status, sample status and results at the test level.

16. Provide monthly data reports that build from the weekly data reports to also include structured results data extracted from clinical results reports.

17. Monthly utilization/cost reports and an annual report (for contract performance period) to the national Oncology Program.

18. Establish a Quality Assurance and Monitoring Plan as outlined in the PWS.

19. 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.

Contract Type and Terms

The effective period of the contract shall be for 12 months from date of award with the option to extend the contract for up to 2 additional 12-month periods, at the discretion of the VA. Total contract period of performance shall not exceed three years.

All services provided shall be in accordance with the costs, terms, and conditions of this contract. The government anticipates award of a Firm Fixed Price (FFP) contract.

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

Single Gene Contract Period: Base POP Begin: 09-27-2022 POP End: 09-26-2023 varies depending on familial mutation

Custom Panel

POP Begin: 09-27-2022 varies depending on personal/family history

Breast Cancer Panel

POP Begin: 09-27-2022

ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, RAD50, STK11, TP53

Breast/Gyn Cancer Panel

POP Begin: 09-27-2022

ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, DICER1, EPCAM, MLH1, MSH2, MSH6, NBN, NF1, PALB2, PMS2, PTEN, RAD50, RAD51C, RAD51D, SMARCA4, STK11, TP53

Colorectal Cancer Panel

POP Begin: 09-27-2022

APC, AXIN2, BMPR1A, CDH1, CHEK2, EPCAM, GREM1, MLH1, MSH2, MSH3, MSH6, MUTYH, NTHL1, PMS2, POLD1, POLE, PTEN, SMAD4, STK11, TP53, ATM, BLM, BUB1B, CEP57, ENG, FLCN, GALNT12, MLH3, RNF43, RPS20

Common Hereditary Cancers

POP Begin: 09-27-2022

APC, ATM, AXIN2, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, CTNNA1, DICER1, EPCAM, GREM1, HOXB13, KIT, MEN1, MLH1, MSH2, MSH3, MSH6, MUTYH, NBN, NF1, NTHL1, PALB2, PDGFRA, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SDHA, SDHB, SDHC, SDHD, SMAD4, SMARCA4, STK11, TP53, TSC1, TSC2, VHL

Multicancer Panel

POP Begin: 09-27-2022

AIP ALK APC ATM AXIN2 BAP1 BARD1 BLM BMPR1A BRCA1 BRCA2 BRIP1 CASR CDC73 CDH1 CDK4 CDKN1B CDKN1C CDKN2A CEBPA CHEK2 CTNNA1 DICER1 DIS3L2 EGFR EPCAM FH FLCN GATA2 GPC3 GREM1 HOXB13 HRAS KIT MAX MEN1 MET MITF MLH1 MSH2 MSH3 MSH6 MUTYH NBN NF1 NF2 NTHL1 PALB2 PDGFRA PHOX2B PMS2 POLD1 POLE POT1 PRKAR1A PTCH1 PTEN RAD50 RAD51C RAD51D RB1 RECQL4 RET RUNX1 SDHA SDHAF2 SDHB SDHC SDHD SMAD4 SMARCA4 SMARCB1 SMARCE1 STK11 SUFU TERC TERT TMEM127 TP53 TSC1 TSC2 VHL WRN WT1

Prostate Cancer Panel

POP Begin: 09-27-2022

ATM, BARD1, BRCA1, BRCA2, BRIP1, CHEK2, FANCL, EPCAM, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53

Renal/Urinary Tract Cancer Panel

POP Begin: 09-27-2022

BAP1, CDC73, CDKN1C, DICER1, DIS3L2, EPCAM, FH, FLCN, GPC3, MET, MLH1, MSH2, MSH6, PMS2, PTEN, REST, SDHB, SDHC, SMARCA4, SMARCB1, TP53, TSC1, TSC2, VHL, WT1

Pancreatic Cancer Panel

POP Begin: 09-27-2022

APC, ATM, BMPR1A, BRCA1, BRCA2, CDKN2A, EPCAM, MEN1, MLH1, MSH2, MSH6, NF1, PALB2, PMS2, SMAD4, STK11, TP53, TSC1, TSC2, VHL

Pancreatitis Panel

POP Begin: 09-27-2022

CASR, CFTR, CPA1, CTRC, PRSS1, SPINK1

Paraganglioma/Pheochromocytoma Panel

POP Begin: 09-27-2022

MAX, NF1, RET, SDHA, SDHAF2, SDHB, SDHC, SDHD, TMEM127, VHL

Melanoma Panel

POP Begin: 09-27-2022

BAP1, BRCA2, CDK4, CDKN2A, MITF, POT1, PTEN, RB1, TP53

Gastric Cancer Panel

POP Begin: 09-27-2022

APC, BMPR1A, CDH1, CTNNA1, EPCAM, KIT, MLH1, MSH2, MSH6, NF1, PDGFRA, PMS2, SDHA, SDHB, SDHC, SDHD, SMAD4, STK11, TP53

Hyperparathyroidism Panel

POP Begin: 09-27-2022

AP2S1, CASR, CDC73, CDKN1B, GNA11, MEN1, RET

Lynch Syndrome Panel

POP Begin: 09-27-2022

EPCAM, MLH1, MSH2, MSH6, PMS2

Schwannomatosis Panel

POP Begin: 09-27-2022

LZTR1, NF2, SMARCB1

Neurofibromatosis Type 1

POP Begin: 09-27-2022

NF1

Neurofibromatosis Type 2

POP Begin: 09-27-2022

NF2

Polyposis Panel

POP Begin: 09-27-2022

APC, MSH3, MUTYH, NTHL1, POLD1, POLE

Familial Hypercholesterolemia Panel

POP Begin: 09-27-2022

APOB, LDLR, LDLRAP1, PCSK9

Cardiomyopathy Panel

POP Begin: 09-27-2022

ABCC9, ACTC1, ACTN2, AGL, BAG3, CACNA1C, CAV3, CRYAB, CSRP3, DES, DMD, DOLK, DSC2, DSG2, DSP, EMD, EYA4, FHL1, FKRP, FKTN, FLNC, GAA, GLA, HCN4, JUP, LAMP2, LMNA, MYBPC3, MYH7, MYL2, MYL3, PKP2, PLN, PRKAG2, RAF1, RBM20, RYR2, SCN5A, SGCD, SLC22A5, TAZ, TCAP, TMEM43, TNNC1, TNNI3, TNNT2, TPM1, TTN, TTR, VCL

Hypertrophic Cardiomyopathy Panel

POP Begin: 09-27-2022

ACTC1, ACTN2, AGL, BAG3, CACNA1C, CAV3, CSRP3, DES, FHL1, FLNC, GAA, GLA, LAMP2, MYBPC3, MYH7, MYL2, MYL3, PLN, PRKAG2, TCAP, TNNC1, TNNI3, TNNT2, TPM1, TTR, VCL

Dilated Cardiomyopathy Panel

POP Begin: 09-27-2022

ABCC9, ACTC1, ACTN2, BAG3, CAV3, CRYAB, CSRP3, DES, DMD, DOLK, DSC2, DSG2, DSP, EMD, EYA4, FKRP, FKTN, FLNC, JUP, LAMP2, LMNA, MYBPC3, MYH7, PKP2, PLN, RAF1, RBM20, RYR2, SCN5A, SGCD, SLC22A5, TAZ, TCAP, TMEM43, TNNC1, TNNI3, TNNT2, TPM1, TTN, TTR, VCL

Hereditary Hemorrhagic Telangiectasia

POP Begin: 09-27-2022

ACVRL1, ENG, GDF2, RASA1, SMAD4

Familial Transthyretin Amyloidosis

POP Begin: 09-27-2022

TTR

Arrhythmia Panel

POP Begin: 09-27-2022

ABCC9, ACTN2, ANK2, CACNA1C, CACNB2, CALM1, CALM2, CALM3, CASQ2, CAV3, DES, DSC2, DSG2, DSP, EMD, FLNC, GPD1L, HCN4 ,JUP, KCNA5, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, LMNA, MYL4, NKX2-5, PKP2, PLN, PRKAG2, RBM20, RYR2, SCN5A, TMEM43, TNNI3, TNNT2, TRDN, TTN

Long QT Panel

POP Begin: 09-27-2022

ANK2, CACNA1C, CALM1, CALM2, CALM3, CAV3, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, SCN5A, TRDN

Polycystic Kidney Disease Panel

POP Begin: 09-27-2022

DNAJB11, GANAB, HNF1B, PKD1, PKD2

Muscular Dystrophy Panel

POP Begin: 09-27-2022

ANO5, B3GALNT2, B4GAT1, CAPN3, CAV3, CHKB, COL12A1, COL6A1, COL6A2, COL6A3, DAG1, DES, DMD, DNAJB6, DPM1, DPM2, DPM3, DYSF, EMD, FHL1, FKRP, FKTN, GAA, GMPPB, ISPD, ITGA7, LAMA2, LARGE1, LMNA, MYOT, PLEC, PNPLA2, POMGNT1, POMGNT2, POMK, POMT1, POMT2, RXYLT1, SGCA, SGCB, SGCD, SGCG, TCAP, TNPO3, TOR1AIP1, TRAPPC11, TRIM32, TTN

Limb Girdle Muscular Dystrophy Panel

POP Begin: 09-27-2022

ANO5, CAPN3, CAV3, DAG1, DES, DMD, DNAJB6, DYSF, FKRP, FKTN, GAA, GMPPB, ISPD, LMNA, MYOT, PLEC, PNPLA2, POMGNT1, POMK, POMT1, POMT2, SGCA, SGCB, SGCD, SGCG, TCAP, TNPO3, TOR1AIP1, TRAPPC11, TRIM32, TTN

Hereditary Neuropathy Panel

POP Begin: 09-27-2022

AARS, AIFM1, ATL1, ATL3, ATP7A, BICD2, BSCL2, CHCHD10, DCTN1, DNAJB2, DNM2, DNMT1, DST, DYNC1H1, EGR2, ELP1, FBXO38, FGD4, FIG4, GAN, GARS, GDAP1, GJB1, GNB4, HARS, HINT1, HSPB1, HSPB8, IGHMBP2, INF2, KIF1A, LITAF, LMNA, LRSAM1, MED25, MFN2, MORC2, MPZ, MTMR2, NDRG1, NEFL, NGF, NTRK1, PDK3, PLEKHG5, PMP22, PRPS1, PRX, RAB7A, REEP1, RETREG1, SBF2, SCN11A, SCN9A, SH3TC2, SIGMAR1, SLC25A46, SLC52A2, SLC52A3, SLC5A7, SPG11, SPTLC1, SPTLC2, TFG, TRIM2, TRPV4, TTR, UBA1, VAPB, VRK1, WNK1, YARS

Charcot-Marie Tooth Panel

POP Begin: 09-27-2022

AARS, AIFM1, BSCL2, DNAJB2, DNM2, DYNC1H1, EGR2, FGD4, FIG4, GARS, GDAP1, GJB1, GNB4, HARS, HINT1, HSPB1, HSPB8, IGHMBP2, INF2, LITAF, LMNA, LRSAM1, MED25, MFN2, MORC2, MPZ, MTMR2, NDRG1, NEFL, PDK3, PLEKHG5, PMP22, PRPS1, PRX, RAB7A, SBF2, SH3TC2, SLC25A46, SPG11, TFG, TRIM2, TRPV4, YARS

Ataxia Repeat Expansion Panel

POP Begin: 09-27-2022

ATN1, ATXN1, ATXN10, ATXN2, ATXN3, ATXN7, ATXN8OS, BEAN1, CACNA1A, FMR1, FXN, NOP56, PPP2R2B, TBP

ALS Panel

POP Begin: 09-27-2022

ALS2, CHCHD10, DCTN1, FUS, KIF5A, OPTN, PFN1, SETX, SOD1, SPG11, TARDBP, TBK1, TFG, UBQLN2, VAPB, VCP, CHMP2B, MATR3, SIGMAR1, SQSTM1

Frontotemporal Dementia Panel

POP Begin: 09-27-2022

CHCHD10, DCTN1, FUS, GRN, MAPT, TARDBP, TBK1, UBQLN2, VCP, CHMP2B, HNRNPA2B1, PSEN1, SQSTM1

C9orf72 Gene

POP Begin: 09-27-2022

C9ORF72

Spinal Bulbar Muscular Atrophy

POP Begin: 09-27-2022

AR gene

Myotonic Dystrophy Type 1

POP Begin: 09-27-2022

DMPK

Myotonic Dystrophy Type 2

POP Begin: 09-27-2022

CNBP

Huntington Disease

POP Begin: 09-27-2022

HTT

CADASIL

POP Begin: 09-27-2022

NOTCH3, HTRA1

Inherited Alzheimer disease

POP Begin: 09-27-2022

APP, PSEN1, PSEN2

Hereditary Spastic Paraplegia Panel

POP Begin: 09-27-2022

ABCD1, ALDH18A1, ALS2, AP4B1, AP4E1, AP4M1, AP4S1, AP5Z1, ATL1, B4GALNT1, BSCL2, C12orf65, CYP2U1, CYP7B1, DDHD1, DDHD2, ERLIN2, FA2H, GBA2, GJC2, HEXA, HSPD1, KDM5C, KIF1A, KIF1C, KIF5A, L1CAM, NIPA1, NT5C2, PLP1, PNPLA6, REEP1, REEP2, RTN2, SACS, SLC16A2, SPART, SPAST, SPG11, SPG21, SPG7, TECPR2, VAMP1, WASHC5, ZFYVE26

Pulmonary Hypertension

POP Begin: 09-27-2022

ACVRL1, BMPR2, CAV1, ENG, SMAD9

Malignant Hyperthermia

POP Begin: 09-27-2022

CACNA1S, RYR1, STAC3

Macular Dystrophies Panel

POP Begin: 09-27-2022

ABCA4, BEST1, C1QTNF5, CDH3, CERKL, CFH, CNGB3, CRB1, CTNNA1, EFEMP1, ELOVL4, FSCN2, GUCA1B, HMNCN1, IMPG1, IMPG2, MFSD8, PRDM13, PROM1, PRPH2, RBP3, RDH12, RLBP1, RPIl1, RPGR, RPGRIP1, RS1, TIMP3

Retinitis Pigementosa Panel

POP Begin: 09-27-2022 up to 80 genes

Familial Hypocalciuric Hypercalecemia

POP Begin: 09-27-2022

AP2S1, CASR, GNA11

Maturity Onset Diabetes of the Young

POP Begin: 09-27-2022

ABCC8, APPL1, BLK, GCK, HNF1A, HNF1B, HNF4A, INS, KCNJ11, KLF11, NUEROD1, PAX4, PDX1

Acute hepatic porphyria

POP Begin: 09-27-2022

ALAD, CPOX, HMBS, PPOX

Myopathy panel

POP Begin: 09-27-2022

Primary Immunodeficiences

Focal Segmental Glomerulosclerosis

Carrier Screen

POP Begin: 09-27-2022

CFTR, SMN1, FMR1

Expanded Carrier Screen

POP Begin: 09-27-2022

ABCC8, ABCD1, ACADM, ASPA, ASS1, BCKDHA, BCKDHB, BLM, CFTR, CLN3, CLRN1, DHCR7, DLD, DMD, ELP1, FAH, FANCC, FKTN, FMR1, G6PC, GAA, GALC, GALT, GBA, GJB2, HBA1, HBA2, HBB, HEXA, IDUA, IL2RG, MCOLN1, NEB, OTC, PAH, PCDH15, PEX1, PEX6, PEX7, PKHD1, PMM2, SLC26A4, SMN1, SMPD1, TMEM216, USH2A