36C26120Q0052-001.docx

STATEMENT OF WORK

Introduction:

The San Francisco VA Health Care System (SFVAHCS) is a comprehensive and integrated health care delivery system that provides quality clinical programs and services to veterans. We offer primary health services, as well as highly specialized, technologically advanced clinical care. The System includes one hospital and six community-based outpatient clinics. The SFVAHCS requires an immunoassay system to assist in this mission. This system must include the ability to perform the following tests:

· Hepatitis A, IgM antibody

· Hepatitis A, IgG antibody

· Hepatitis B Surface antibody

· Hepatitis B Surface antigen

· Hepatitis B core IgM antibody

· Hepatitis B core Total antibody

· Hepatitis C antibody

· HIV antibody/antigen combination assay

· BNP

· Homocysteine

· Cyclosporine

· Sirolimus

· Tacrolimus

· Troponin

· Syphilis

· Free T4

· Total T3

· TSH

· Procalcitonin

Requirements

A. Cost Per Test (CPT)

Contractor shall provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the Contractor's equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition (this element includes both preventative maintenance and emergency repairs) and (d) training for Government personnel. Delivery, installation, and removal of equipment is provided at no additional charge.

B. Cost Per Reportable Result (CPRR)

Contactor shall provide a price for a reportable patient result. The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor's equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the Government such as printer paper, labels, etc. This per patient reportable result price will also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, calibration and-correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CSLI). (c) All necessary maintenance to keep the equipment in good operating condition (this element includes both preventative maintenance and emergency repairs) and (d) training for Government personnel. Delivery, installation, and removal of equipment is provided at no additional charge.

C. VA San Francisco CPRR Demand

Contractor shall ensure that items listed in Sections A and B are sufficient to meet current system demands. Table 1-1 estimates the demand of reported patient results (note: does not include calibrations, quality control, verifications, repeats, etc.)

Table 1-1 Estimated Demand of Tests (volume)

Please note the above volumes are estimates only. The Contractor shall provide annual reconciliation reports to the Contracting Officer, to determine if additional tiered-pricing discounts are applicable.

D. Testing Requirements

The CPRR service shall be inclusive of the following requirements:

1. The vendor must be able to provide an HIV antibody/antigen combination assay. This is commonly known as 4th generation or higher.

2. The vendor will provide a specialist to perform method validations after the installation of the analyzer. Method validations may include but not limited to the following:

a. Correlation studies using SFVA specimens.

b. Linearity and determining the Analytic Measurement Range

c. Precision using Quality Control Material

d. Review and/or verification of common interferences with each assay.

e. Carry-over studies

3. Immunosuppressive drug testing is important to prevent graft rejection of transplanted organs in recipient patients. Results of the cyclosporine, sirolimus, and tacrolimus must show excellent correlation and agreement with the existing Abbott methods in use, since re-baselining of all patients will be challenging and may compromise patient care.

4. System must be able to record all quality control results and perform statistical analyses and generate levy-Jennings graphs and Quality Control summaries on a monthly basis.

5. System must meet space and power capacity of the SFVA laboratory. The limitation of the SFVA laboratory is such that only 110 V emergency power outlets are available for each of the two identical analyzers. 208V Emergency outlets are not available due to the limitations of the Laboratory’s emergency power panel. Contractor shall meet with COR to establish acceptable dimensional specifications.

6. Liquid waste must be able to be plumbed to a floor drain and have a non-floor drain waste option.

7. As specified in Table 1-1, two identical analyzers must be provided to accommodate the daily volume of samples for load balancing and for backup purposes in the event that one analyzer requires service or maintenance. Only 110 V emergency power outlets are available for each analyzer. 208/220 V emergency power is not available.

E. Information Technology Requirements

VA San Francisco shall be linked electronically, for patient results, Quality Control and Rules. Government requires bidirectional interface for system communication. Contractor shall provide reimbursement of LIS interface. Contractor shall provide documentation that the driver is available from Data Innovations for their instruments. Contractor shall supply variable power UPS/printers and repair/replace as needed. Contractor shall supply software upgrades and installation to all instruments at no cost to VA, when released by manufacturer, and when required for instrument/testing performance. Government requests that Generic procedure be available on disc in Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) format.

F. Personnel Training

Contractor shall provide initial and recurring training for medical personnel. Initial training shall include one training slot per analyzer at the Customer Training Facility. Recurring training shall include at least one (1) slot per analyzer, for each option year exercised.

G. Technical Support

Contractor shall provide hotline support 24 hours per day, 7 days per week. Contractor shall provide service Monday — Friday, 8 a.m. — 6 p.m., for routine preventative maintenance and problem resolution. In the case of emergency maintenance, Contractor shall provide onsite field representative within 24 hours of notification. All parts, labor, and travel shall be included in the CPT/CPRR pricing.

H. Precedence of Existing FSS Contract

Contractor shall not perform work that directly conflicts with, or is outside the scope of, its existing CPRR FSS contract. If work outlined in this SOW appears to be in conflict or outside scope of FSS contract, Contractor shall stipulate which requirement is in conflict/outside scope in its solicitation response. CPT/CPRR pricing shall then be exclusive of these particular requirements.

I. Period of Performance

The period of performance shall consist of a base period, followed by zero (0) one-year options, which may be exercised at the discretion of the Government. The estimated period of performance is as follows:

Base Period: December 1, 2019 to November 30, 2020

J. Transition

Contractor shall diligently work with incumbent to ensure timely transition of service, ensuring no interruption of laboratory operations or patient care. Removal of incumbent's equipment, as well as installation and setup of new Contractor's equipment shall be coordinated through the Contracting Officer.