sow 2025-Rev 1.docx

Statement of Work

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Lease of Free Kappa/Lambda Analyzer

2. Scope of Work: The contractor shall provide FDA approved instrumentation with service, reagents, controls and calibrators to support Kappa and Lambda Free Light Chain testing.

3. Performance Period: The period of performance is to be for a base year and four ordering periods.

4. Type of Contract: This is a firm fixed-price contract.

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. The Analyzer System shall come with Computer, UPS, and printer. Service for the analyzer and training for two technologists to be included. Analyzer to be delivered and set up within 60 days of contract award. Training to be scheduled within 6 months of delivery.

2. Reagents and consumables listed below are to be shipped on an IDIQ basis. The department will call when reagents/supplies are needed.

Item #

Item

K-FREE KIT

L-FREE KIT

IgA IgG IgM Hu C3c Hu C4

PREALBUMIN

CERULOPLASMIN

HAPTOGLOBIN

RHEUMATOID FACTOR

NECESSARY DILUENTS FOR SYSTEM

SAMPLE CUPS 0.5 mL SAMPLE CUPS 2 mL

CUVETTES TENCEL

WASHING SOLUTION 20 mL WASHING SOLUTION 100 mL TUBING MAINTENANCE SOLUTION 20 Ml

Quantity

D. PERFORMANCE REQUIREMENTS

1. Maintenance: The lease shall have the provision for the contractor to 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. On site repairs: Contractor will dispatch on-site support personnel within 24 business hours of determining that phone support is insufficient to correct problem. After repair, the contractor shall submit a detailed work report to include all required materials at no charge to the facility.

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

j. 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. Training: The contractor will provide (on-site, off-site) training, (detail specific training needs)

3. 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.

4. 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 this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

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

F. CONTRACTOR SECURITY REQUIREMENTS

This contractor requires no access to CAVHS or any VA information system. The analyzer will be interfaced to the CAVHS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.”

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information development by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor’s rights to use data as described in Rights in Data – General, FAR 52.227-14(d)(1).

VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.”

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 Arkansas Veterans Healthcare System (CAVHS). at the end of the contract.

H. GOVERNMENT PERSONNEL OBSERVED HOLIDAYS:

1. The Government hereby provides notice and Supplier hereby acknowledges receipt that Government personnel observe the listed days as holidays:

New Year's Day Martin Luther King's Birthday President's Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas

2. In addition to the days designated as holidays, the Government observes the following days:

Any other day designated by Federal Statute Any other day designated by Executive Order Any other day designated by the President’s Proclamation