Attachment B SOW- Immunoassy Testing Reagents.docx

Statement of Work- VISN22 Pathology and Laboratory Medicine Services Introduction

The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to the VA Long Beach Healthcare System, VA Great Los Angeles Healthcare System, VA Loma Linda Healthcare System, VA San Diego Healthcare System, and VA Southern Arizona Healthcare.

Background

The Pathology and Laboratory Medicine Service (PALMS) is part of the Desert Pacific Healthcare Network (VISN 22). These facilities are teaching hospitals, providing a full range of patient services, with state-of-the art technology as well as education and research. It also boosts one of the largest and most diverse patient populations in the VA system.

Scope

The contractor shall provide reagents, supplies, consumables and perform all necessary repair and preventative maintenance services for the equipment.

1. All reagents, supplies, and consumables must be compatible with existing DiaSorin Liaison XL instruments for immunoassay testing through “Flash” chemiluminescence technology (CLIA) with a paramagnetic microparticle solid phase (MP).

2. The use of the reagents, supplies, and consumables must not void the warranty on existing DiaSorin Liaison XL instruments.

3. The vendor shall provide the facilities with Food and Drug Administration (FDA) approved reagents and any consumable parts necessary for analyzing/testing on all instruments.

4. The vendor shall provide the facilities with at minimum Emergency Use Authorization (EUA) Food and Drug Administration (FDA) approved SARS-CoV-2 reagents and any consumable parts necessary for analyzing/testing on all instruments.

5. All assays must at minimum be based internal master curve with a two-part calibration.

6. All reagents and consumables shall be ready to use (i.e. no preparation by staff to prior to use).

7. All reagents and consumables shall have barcodes for instrument identification.

8. Service for one DiaSorin Liaison XL instruments at Long beach location.

Term of Agreement This will be firm-fixed price one year contract with 6 month extension option.

Reagents The vendor shall ensure the following:

Reagents will be ordered on as needed basis All of the reagents shall be prepackaged and ready for use These items shall be of the highest quality, sensitivity and tested to assure precision and accuracy Expiration dates must be clearly marked on all reagent containers and no shorter than 12 months out.

The vendor shall state the open date stability for all reagents and kits The vendor shall notify the facility of the expected shipment date of reagents The vendor shall pay all shipping and handling fees for supplies The vendor shall package reagents in such a manner as to ensure the integrity of the reagents, kits and supplies during transport The vendor shall explain their policy on replacement of unsuitable or damaged products or reagents/kits shipped in error.

The vendor shall supply all Safety Data Sheets for their proposed reagents The vendor shall inform the participating facilities of any reagent recalls or bulletins due to product unavailability due to manufacturing issues.

Alert/Notifications of any delays in shipment as well as all technical advisory/recalls, prior to or simultaneously with field alerts should be forwarded to the participating facilities.

The vendor shall provide their plan for product availability if reagents become scarce or unavailable.

The vendor shall provide an acceptable itemized bill for all items shipped for payment with each shipment.

Order method The participating facilities may order reagents via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the reagents by number, quantity, purchase price, address for delivery, and any special instructions. The vendor shall provide the ability to ship reagents monthly to the participating facilities. The vendor shall provide the ability to ship reagents on an “as needed” basis to the participating facilities.

Hours of Operation

· Normal tour-of-duty hours for VISN22 Pathology & Laboratory Medicine and services (PALMS) is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor’s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.

· In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”

When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

Location Service Locations VISN22:

VA Long Beach Healthcare System (VALBHS) 5901 E. 7th Street Long Beach, CA 90822;

VA Loma Linda Healthcare System (VALLHS) 11201 Benton Street Loma Linda, CA 92357;

VA San Diego Healthcare System (VASDHS) 3350 La Jolla Village Dr. San Diego, CA 92161;

VA Southern Arizona Healthcare System (VA Tucson) 3601 S 6th Ave Tucson, AZ 85723;

VA Greater Los Angeles Healthcare System West LA Campus (VAGLAHS) 11301 Wilshire Blvd Los Angeles, CA 90073;

Security

Information Security

· The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor’s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

· The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 “SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES” sited in section C. Contract Clauses

(a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov

(b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov

Contract Personnel Security

All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.