A1 - Statement of Work - iFOBT CPT.pdf

STATEMENT OF WORK

iFOBT Cost-Per-Test

Central Texas Veterans Health Care System

A. GENERAL INFORMATION

1. Purpose: The Central Texas Veterans Health Care System (CTVHCS) requires an FDA cleared and approved automated Immunochemical Fecal Occult Blood Test (iFOBT) analyzer for the testing and diagnosis of veteran patients. The requirement also includes all of the reagents and consumable supplies required for specimen analysis.

2. Background: The CTVHCS laboratory has utilized a Polymedco OC Auto Micro 80 iFOBT Analyzer for more than 8 years. The iFOBT immunoassay method does not have the limitations that the Guaiac method has and does not require a dietary restriction. This automated method eliminates the subjectivity of reads and optimizes the sensitivity and specificity of the immunoassay method.

3. Scope of Work: The contractor shall provide the lease/rental of an iFOBT analyzer with all necessary reagents/consumable supplies on a cost-per-test (CPT) basis.

Location:

Central Texas Veterans Health Care System Pathology & Laboratory Medicine Service 1901 Veterans Memorial Dr.

Temple, TX 76504-7451

4. Performance Period: The period of performance will be a base year, 10/1/2022 to 9/30/2023, and include four (4) option periods.

5. Type of Contract: This is a firm-fixed-price single-award Blanket Purchase Agreement

(BPA).

B. GENERAL REQUIREMENTS

All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

C. TASKS, DELIVERABLES/SUPPLIES

1. Rental, maintenance, and service of iFOBT analyzer

2. Reagents and consumables for iFOBT CPT tests

Schedule of Deliverables

The consumable supplies (see schedule) that are not included with the reagents will be ordered (calls) on an as-needed basis.

D. PERFORMANCE REQUIREMENTS

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1. Maintenance: The contractor shall perform preventative maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

a. Inventory and recording of systems components.

b. Monthly deliverables shall be received in full.

c. Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

d. After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government.

e. Delivery of PM parts or materials: the contractor shall provide all preventative service materials at no additional cost to the government.

f. Repairs and support

g. Technical support: Support Personnel will be available by telephone from 0800 to

1700 each business day.

h. For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost to the government.

i. Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to, but not limited to, repairs, replacements, recall, and upgrades without any cost to the government.

2. Safety: Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation.

3. Test Performance: All tests, procedures, and equipment must perform at manufacturer specifications. Deviations from the performance specifications shall be corrected by the contractor.

a. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control, and CAP peer evaluation.

E. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of the BPA, are the exclusive property of the U.S. Government and shall be submitted to the Contracting Officer at the conclusion of the BPA.

2. The Contracting Officer or the Ordering Officer are the sole individuals authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to each task order. No information shall be released to the public by the contractor. Any request for information relating to each task order, submitted in writing by the contractor, shall be submitted to the Contracting Officer or the Ordering Office for response.

36C25722Q0726 Page 3 of 4

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the Contracting Officer.

F. CONTRACTOR SECURITY REQUIREMENTS

This contractor does not require access to the CTVHCS information system, or any other VA information system. The iFOBT analyzer will be interfaced to the CTVHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

The C&A requirements do not apply. A security accreditation package is not required.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

G. RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to Central Texas Veterans Healthcare System (CTVHCS) and must be returned to CTVHCS at the end of the contract.

“VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

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

a. Documentation requirements:

1. If fully vaccinated, shall show proof of vaccination

1. NOTE: 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

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.

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.

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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.

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 following website: https://www.va.gov/covid19screen (COVID-19 Screening Tool). Regularly check the website for updates.

a. Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.”

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