36C26324Q0493_1.docx

Presolicitation Notice Presolicitation Notice CareDx AlloSure Laboratory Reference Testing Statement of Work

1. SERVICES PROVIDED

1.1. Contractor shall provide specialized molecular laboratory testing services – the testing service must detect transplanted kidney rejection using Cell-Free DNA Test – on specimens for the Iowa City VA Health Care System (ICVAHCS). Work will be performed at the contractor site for fees based on CMS rates agreed upon in the cost/price section of the contract.

1.2. The Contractor shall provide a mobile lab service for drawing patient samples at the patient’s home at no additional cost to the ICVAHCS or patient. If requested, additional laboratory specimens pertinent to patient care shall also be drawn and delivered to the ICVAHCS at no additional cost the same day. The ICVAHCS shall communicate what samples to draw and provide the contractor with copies of laboratory orders in a timely manner prior to the mobile lab performing services at the patient’s home. The samples drawn at the patient’s home shall be mailed directly to Contractor by the mobile lab service technician.

1.3. The Contractor shall provide a list of tests with reference ranges, specimen requirements, testing methodology, turnaround time of testing, processing and analysis of the specimen, and reporting of specimen results. Consultation regarding test selection, collection, transportation, and result interpretation shall also be provided when necessary. The Contractor shall provide collection and shipping supplies including tubes, boxes and prepaid shipping labels at no additional cost to ICVAHCS.

1.4. Contractor shall provide laboratory services on and as needed basis Monday through Friday, 8:00 am to 5:00 pm PST, excluding federal and contractor holidays.

1.5. The eleven (11) holidays observed by the Federal Government are as follows:

1.5.1. New Year’s Day

1.5.2. Martin Luther King’s Birthday

1.5.3. President’s Day

1.5.4. Memorial Day

1.5.5. Juneteenth

1.5.6. Independence Day

1.5.7. Labor Day

1.5.8. Columbus Day

1.5.9. Veterans Day

1.5.10. Thanksgiving

1.5.11. Christmas

1.5.12. Any other day specifically declared by the President of the United States to be a national holiday.

1.8. No additional services are authorized without prior approval through the Contracting Officer Representative and/or Contracting Officer.

1.9. The services specified herein may be changed by written modification to this contract. The modification, including the exercise of an Option Year, will be prepared by the VA Contracting Officer and, prior to becoming effective, shall be approved by the contractor as part of the bilateral modification process.

1.10. The Contractor shall advise the ICVAHCS of any changes in testing methodology, procedures, and reference ranges. In the event the Contractor changes a critically important component of a test, the Contractor shall notify the VA Contracting Officer and the Iowa City VA Laboratory Director prior to the intended change. The Contractor shall provide documentation that the quality and efficacy of the test will remain unchanged or be improved.

1.11. This will be a firm fixed-price indefinite-delivery indefinite-quantity commercial services contract for all items listed in the cost/price section of the contract.

1.12. The effective period of the contract shall include one (1) base year with options to extend the contract, at the discretion of the ICVAHCS, for up to four (4) additional years. The Contractor shall be notified by written notice, within thirty (30) days of the contract anniversary date of the VA’s intent to renew.

2. REPORTING TEST RESULTS

2.1. Reporting of results must include:

2.1.1. Patient’s name, identification code, date of birth, or Social Security number

2.1.2. Physician’s name (if supplied)

2.1.3. VA facility name

2.1.4. Patient’s location (if supplied)

2.1.5. Test ordered

2.1.6. Date/time of specimen collection (when available)

2.1.7. Date/time received in testing facility

2.1.8. Date of test completed

2.1.9. Test result

2.1.10. Flag abnormal values

2.1.11. Reference Range

2.1.12. Toxic and/or therapeutic range where applicable

2.1.13. Name of testing laboratory

2.1.14. Testing laboratory specimen number

2.1.15. Type of specimen

2.1.16. Comments related to the test provided by submitting laboratory

2.1.17. Results must be accessed through a secure electronic means.

2.2. Information that may indicate a questionable validity of test results, unsatisfactory specimen shall be reported with reason as to its unsuitability for testing.

2.3. For test results being returned to VA laboratories running VISTA Lab, Referral labs are to include a VA ICN or VA EDIPI number with patient reports as an identifier. VA referring VISTA labs are to supply the patients VA ICN or VA EDIPI with each lab order to enable the referral lab to include it with results returned to the VA.

3. CONTINUITY OF SERVICES

3.1. The contractor will ensure that adequate staffing is available to perform contracted testing in a timely manner.

4. DISASTER/EMERGENCY COVERAGE

4.1. In the event of a Federal, local or community disaster or emergency, the Contractor will, to the maximum extent practicable in the circumstances, as determined by the VA, to continue to provide services to the VA at the same level as is contained in this contract.

5. LICENSING AND ACCREDITATION

5.1. Contractor must be regularly established in the business of diagnostic laboratory, pathology, molecular and cytogenetic testing.

5.2. Contractor must be financially responsible and have the necessary equipment and personnel to furnish services in the volume required.

5.3. Contractor’s facility shall have all licenses, permits, accreditation, and certificates required by federal and state law to provide laboratory testing services.

5.4. Contractor’s laboratory shall have current copies of the following documents upon request by the COR:

5.4.1. CLIA License (satisfies requirement that all employees are licensed and meet all OSHA safety standards)

5.5. Contractor’s laboratory shall be currently accredited by the College of American Pathologists (CAP).

5.6. Contractor shall hold certificate of insurance for general liability and malpractice insurance, workmen’s compensation and vehicle insurance. Prior to award of the contract, the Contractor shall furnish to the VA a certificate of insurance evidencing that all required coverage has been obtained. The Contractor shall be responsible for maintaining this certificate/coverage for the duration of the contract. The insurance coverage may not be changed or canceled without a thirty (30) day written notice to the VA Contracting Officer.

5.7. The contractor’s Laboratory Director shall be a licensed physician or a licensed bio-analyst.

5.8. The contractor’s facilities, methodologies and quality control procedures may be examined by representatives of the VA at any time during the life of the contract.

5.9. Contractor agrees to maintain the minimum acceptable service, reporting systems, and quality controls specified herein.

5.10. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

6. SPECIAL CONTRACT REQUIREMENTS AND LEGAL QUALIFICATIONS

7. COVID-19 SAFETY PROTOCOL FOR FEDERAL CONTRACTORS

7.1. Contractor employees who work in or travel to VHA locations must comply with the following documentation requirements:

7.1.1. If fully vaccinated, shall show proof of vaccination. Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

7.1.2. If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

7.1.3. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

7.1.4. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

7.2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

8. RECORDS MANAGEMENT REQUIREMENTS

8.1. “Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record includes:

8.1.1. [Agency] records.

8.1.2. Does not include personal materials.

8.1.3. Applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

8.1.4. May include deliverables and documentation associated with deliverables.

8.2. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

8.3. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

8.4. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

8.5. Iowa City VAHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Iowa City VAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Iowa City VAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

8.6. Authorities: Contractor’s physician(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

8.7. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

8.8. Disclosure: Contractor’s physician(s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.01, Health Information Management and Health Records and VHA Directive 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

8.9. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 and all guidelines provided by the VAMC.

8.10. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following addresses: Iowa City: Michele Myrvik, Veterans Affairs Health Care System, 601 Highway 6 West, Iowa City, IA, 52246.

8.11. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Iowa City VAHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph 6.4.

8.12. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Iowa City VAHCS guidance for protecting sensitive, proprietary information, and controlled unclassified information.

8.13. The Contractor shall not create or maintain any records containing any non-public Iowa City VAHCS information that are not specifically tied to or authorized by the contract.

8.14. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

8.15. The Iowa City VAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Iowa City VAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

9. STANDARD OF CARE

9.1. The standard of care should be equal to that provided by the VA if the VA were capable of providing the services required at their location. The contractor shall provide competent, quality services to all patients of the Iowa City VAHCS in the performance of contract requirements. Contractor shall provide all services specified in this contract for any VA beneficiary, regardless of the race, color, religion, sex, or national origin of the person for whom such services are ordered. The Contractor further warrants that he/she shall not resort to subcontracting as a means of circumventing this provision.

10. CONFLICT OF INTEREST

10.1. The Contractor is responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or sub-Contractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest.

11. ACCOUNTING/INVOICES

11.1. The Contractor shall submit monthly invoices to the ICVAHCS Laboratory Administrative Officer and/or Budget Technician for services rendered.

11.2. All costs will be charged only to the ICVAHCS at the designated rate(s) as listed in the Price Schedule. Those rates will be all-inclusive based on the described service categories herein. The Contractor shall communicate any CMS rate changes at least 30 days in advance to the ICVAHCS.

11.3. All invoices sent to the VA Laboratory shall reference the vendor name and address, the Customer (Iowa City VAHCS contact phone number and purchase order number Invoices shall be accurate and shall display chronologically by date of service the name of the patient, date of service, description of service provided including CPT code, quantity, unit price and total invoice amount.

11.4. Vendor Electronic Invoice Submission Methods such as Facsimile, e-mail, 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 electronic data transmission methods below:

11.4.1. Invoices will be electronically submitted to the Tungsten website at https://www.tungsten-network.com/customer-campaigns/veteransaffairs/ and Tungsten direct vendor support number is 1-877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support:

Phone: 1-877-489-6135 Website: https://www.tungsten-network.com/customer-campaigns/veteransaffairs/ Department of Veterans Affairs Financial Service Center:

Phone: 1-877-353-9791 Email: vafscenterprisesupport@va.gov

11.5. The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than the Iowa City VA HCS for services provided pursuant to this contract, even if the VA does not pay for those services. It shall be considered fraudulent for the Contractor to bill other third-party insurance sources (including Medicare) for services rendered to VA beneficiaries under this contract. This provision shall survive the termination or ending of the contract.

12. CONTRACT PERFORMANCE MONITORING

12.1. Monitoring of Contractor’s performance shall be done by the Contracting Officer’s Representative (COR). Incidents of contractor non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. Upon award, a Quality Assurance Surveillance Plan will be signed by the Contractor Program Manager and COR, outlining the evaluation criteria to ensure the Contractor is aware of the management and quality criteria.

12.2. Frequency of Measurement:

12.2.1. During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed. Quarterly reports are prepared and completed by the COR within 45 days of the end of the reporting period.

12.3. Frequency of Performance Assessment Meetings:

12.3.1. The COR shall visit/correspond with the Contractor on a quarterly basis, at a minimum. If issues arise the COR shall visit/correspond on an as-needed basis, and shall provide a written assessment. This written assessment will be forwarded to the Contracting Officer as documentation of Contractor’s performance and/or for a request to exercise option period, renewal of a contract or termination of a contract.

12.4. Contractor will review quarterly performance reports and acknowledge receipt of report by returning a signed copy, along with any comments, to the Contracting Officer within 30 days of receipt of the report.

12.5. CPARS reporting and registration

12.5.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $150,000, and shares those evaluations with other Federal government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

12.5.2 Each Contractor whose contract award is estimated to exceed $150,000 requires a CPARS evaluation. A Government Focal Point will register your contract within 30 days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

12.5.3 For contracts with a period of one (1) year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one (1) year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have 60 days to submit any comments and re-assign the report to the CO.

12.5.4 Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

GENERAL INFORMATION

SET-ASIDE

601 Highway 6 West

Iowa City IA

COUNTRY

CONTACT INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

POINT OF CONTACT*

Contracting Officer Shavokie Gibson shavokie.gibson@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a presolicitation notice for Lab Referencing Testing. Attached is the SOW for potential vendors to start review and pricing. The follow-on solicitation should be release in the very near future. This pre-solicitation notice does not bind the Government to solicit for bids.

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Presolicitation Notice