AttachmentB- SOW .pdf

Statement of Work

I. Introduction

The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to the laboratories in Desert Pacific Healthcare Network (VISN 22) for molecular testing.

II. Background

The Desert Pacific Healthcare Network (VISN 22) is one of the most diversified tertiary health care providers in the VA. They 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.

The microbiology departments have become reference laboratories for VA facilities within VISN 22 for infectious disease testing. This has allowed VISN 22 to benefit from reduced cost of send outs as well as improved turnaround time. In order to maintain the in-house laboratory, the department requires the use of specific reagents and consumables utilized for testing. The specific material is essential to continued function as they have been validated, which is a requirement for initial use and ongoing testing.

III. Scope

1. Obtain reagents and consumables that are compatible with the existing Cepheid GenXpert and Infinity Instrumentation in VISN22. Reagents and consumables should be priced as cost per test to continue to support the Cepheid Instruments placed at the VISN22 hospitals. Instrumentation shall be able to perform molecular infectious disease and oncology testing for the following assays:

MRSA – Methicillin Resistant Staphylococcus aureus C. diff – Clostridium difficile

CRE – Carbapenemase resistance mechanism detection

MTB – Mycobacterium tuberculosis

RIF – Rifampin Resistance

CT/NG – Chlamydia trachomatis/ Gonorrhea

Strep A – Streptococcus group A

Vaginal Panel – Bacterial vaginosis, Trichomonas vaginalis, Candida species

BV – Bacterial vaginosis

TV – Trichomonas vaginalis

Respiratory Panel: SARS-CoV-2, Flu A, Flu B, RSV

SARS-CoV-2 – Novel coronavirus strain that causes COVID-19

Flu – Influenzae A and B

RSV – Respiratory Syncytial Virus

FII/FV – Factor II and Factor V for thrombosis

BCR-ABL – BCR-ABL for Chronic Myelogenous Leukemia

BCR-ABL P190 – BCR-ABL p190 and ABL mRNA for Chromic myelogenous Leukemia and Acute Lymphoblastic Leukemia.

2. Products Required to meet these needs:

Material Number Material Description

XP3SARS-COV2-10 Xpert® Xpress CoV-2 plus

XPCOV2/FLU/RSV-10 Xpert® Xpress CoV-2/Flu/RSV plus

GXCARBAR-10 Xpert® Carba-R

GXCDIFF/EPI-10 Xpert C. Diff/Epi

GXMRSA-NXG-10 Xpert MRSA NxG

GXCT/NG-10 Xpert® CT/NG, IVD

GXTV-10 Xpert® TV, IVD

GXMTB/RIF-US-10 Xpert MTB/RIF

GXFIIFV-10 Xpert FII/FV

XPRSTREPA-10 Xpert Xpress Strep A

CT/NG and TV Swab Collection Kit

URINE/A-50 CT/NG and TV Urine Collection Kit

SDPS-120 Cepheid Single Use Disposable Swab (120)

GXBCRABL-US-10 BCR-ABL Ultra, US-IVD

RBCRABLP190 BCR-ABL Ultra p190

3C057N Nasopharyngeal Sample Collection Kit

3C064N Nasal Sample Collection Kit

SWAB/G-50-US Collection Kit, Xpert Swab, US IVD, 50

XPRSMVP-10 Xpress, MVP, US-IVD

3. Consumables shall be provided for each of the clinical laboratories located at the VISN 22 facilities:

VA Albuquerque, NM

VA Phoenix, AZ

VA Tucson, AZ

VA Prescott, AZ

VA San Diego, CA

VA Long Beach, CA

VA Loma Linda, CA

VA Los Angeles, CA

4. Service shall be provided for Cepheid Infinity and GenXpert Systems. Service technicians must be authorized by Cepheid to work on Cepheid equipment.

A. Service coverage as part of cost per test model for Cepheid GenXpert Systems.

a. Unlimited service visits Monday through Friday from 8:00 a.m. to 5:00 p.m.

(local time).

b. Customer Support Center Specialists are available by phone 24 hours a day, 365 days a year to assist in troubleshooting.

c. All necessary warranted repair parts and the travel and labor to install parts.

d. Labor and preventive maintenance kits for preventative maintenance visit(s).

e. Response for emergency repairs within 24 hours of request Monday through

Friday local time.

f. Remote access connectivity for problem identification, training, and monitoring.

g. A maximum labor charge for each service visit outside of contract coverage hours.

h. System repaired at customer site.

i. Preventative maintenance visits.

j. Factory authorized updated/modifications.

k. Staff must be Cepheid trained and certified to work on Cepheid instrumentation.

l. Staff must be Cepheid certified to work on the Cepheid Infinity and GenXpert

Systems.

ITEM DESCRIPTION

GenXpert Serial # 830232 (Sothern Arizona)

GenXpert Serial # 830315 (Long Beach)

GenXpert Serial # 830074 (Loma Linda)

GenXpert Serial # 830236 (New Mexico)

GenXpert Serial # 802831 (Los Angeles)

GenXpert Serial # 831595 (Los Angeles)

GenXpert Serial # 802725 (Los Angeles)

GenXpert Serial # 829937 (San Diego)

GenXpert Serial # 800392 (San Diego)

GenXpert Serial # 829561 (Phoenix)

GenXpert Serial # 830235 (Phoenix)

IV. Hours of Operation

Normal tour-of-duty hours at VA LB and VA SD 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”

New Year’s Day January 1st

Martin Luther King’s Birthday Third Monday in January

President’s Day Last Monday in January

Memorial Day Last Monday in January

Juneteenth June 19th

Independence Day July 4th

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day November 11th

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25th

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.

V. Security

1. 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:

(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

2. 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.