ATTACHMENT A_DRAFT SOW.pdf

Department of Veterans Affairs Pathology & Laboratory Medicine Service (P&LMS)

VISN 16

G.V(Sonny) Montgomery VAMC

1500 E Woodrow Wilson Av Jackson MS 39216

Alba Brand Tube Blood Bank Reagents

1. PURPOSE

The purpose is to provide Alba Brand Tube method Blood Bank reagents for the support of Transfusion Medicine Testing. The Blood Bank department performs a range of tests which include type and screen, antibody identification, and crossmatches. Physicians rely on the accuracy and timeliness of these tests in order to administer potentially lifesaving treatments through blood and other blood products. Jackson, MS VAMC use tube reagents as a back up to their primary testing method or as supplemental testing.

2. SCOPE

2.1. The Contractor shall be able to provide all listed reagents.

2.2. Reagents will be shipped on a standing order schedule.

2.3. All products must meet all salient characteristics defined in this section.

2.4. All reagents must meet manufacturers and VA specifications.

2.5. The Contractor shall perform to the standards in this contract.

2.6. SALIENT CHARACTERISTICS

• All the reagents shall be prepackaged and ready for use.

• All reagent red blood cells must be in compliance with the Code of Federal regulations-21 CFR Part 660 Subpart D-Reagent Red Blood Cells.

• 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.

• Unexpected changes in methodology/technology shall be at the expense of the contractor.

• The contractor shall state the open date stability for the reagents for both room temperature and refrigeration.

• The contractor shall package reagents in such a manner as to ensure the integrity of the reagents during transport.

• The contractor shall explain their policy on replacement of unsuitable or damaged products or products shipped in error.

• The contractor shall supply all package inserts, Safety Data Sheets, and other relevant information for their proposed reagents.

• The contractor shall inform each COR of any reagent recalls or bulletins due to product unavailability due to manufacturing issues.

• Alert/Notifications of any delays in shipment as well as any or all technical advisory/recall/alerts, prior to or simultaneously with filed alerts should be forwarded to each contracting officer.

• The contractor shall provide their plan for product availability if supplies/products become scarce or unavailable.

• Vendor shall provide a VA acceptable itemized bill for all items shipped for payment with each shipment.

• Payments will be made in arrears.

2.7. DELIVERY & SHIPPING

2.7.1. Delivery of reagents will be on an as standing order basis.

2.7.1.1 Locations:

1) G.V (Sonny) Montgomery VAMC 1500 E Woodrow Wilson Ave Jackson, MS

Basement, Laboratory C-19 Attn: Blood Bank

2.7.2. Contractor shall deliver all reagents acceptably packaged to each location listed.

2.7.3. Contractor shall ship reagents on a standing basis to each location as follows:

G.V (Sonny) Montgomery VAMC

Reagent Quantity Frequency Total

A1 Cells 2 Every 4 weeks 28

A2 Cells 2 Every 4 weeks 28

B Cells 2 Every 4 weeks 28

Antibody Screening Cells (3 Panel)

2 Every 4 weeks 28

Antibody Identification Cells (10 Panel)

1 Every 4 weeks 13

IgG Sensitized Cells 4 Every 4 weeks 52

C3 Cells 2 Every 4 weeks 28

QC Kit 1 Every 4 weeks 13

3. INSPECTION AND ACCEPTANCE:

3.1. The COR shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer.

3.2. The designated COR’s for each facility are as follows:

G.V (Sonny) Montgomery VAMC Point of contact given after contract award.

4. DELIVERY/STORAGE REQUIREMENTS

4.1. Deliver reagent materials to job in manufacturer's original sealed containers with brand name marked thereon.

4.2. Package to prevent damage or deterioration during shipment, handling, and storage.

4.3. Deliver specified items only when the site is ready to proceed.

4.4. Store products in dry condition inside enclosed facilities.

4.5. Delivery dates will be communicated when products orders are placed.

4.6. Delivery will be coordinated through the Blood Bank Supervisor for the G.V (Sonny) Montgomery VAMC and the Blood Bank Supervisor for VHSO.

5. Installation is not required.

6. DELIVERABLES

6.1

Reagent Type

A1 Cells Tube

A2 Cells Tube

B Cells Tube

Antibody Screening cells-3 Panel Cell Tube

Antibody Identification Cells -10 Panel Cell Tube

IgG sensitized Cells Tube

QC Kit Tube

C3 Coated Cells Tube

7. SECURITY REQUIREMENTS

7.1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

7.2. SECURITY CLAUSE:

"A&A requirements do not apply--Security Accreditation Package is not required".

8. NARA Records Management Language Clause:

The following standard items relate to records generated in executing the contract and should be included in a typical contract:

8.1 Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

8.2 In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

8.3 In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created while performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

8.4 G.V. Sonny Montgomery VAMC (GVSMVAMC), Veterans Health Care System of the Ozarks (VHSO) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

8.5 The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. Contractor personnel shall sign VA Form 10-0708 “Employee Clearance from Indebtedness” before resigning or termination from Contractor working for GVSMVAMC, VHSO and Facility Records Officer must sign form. A copy of completed signed VA Form 10-0708 (Contractor personnel and Facility Records Officer signatures) shall be place in each competency folder. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

8.6 The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

8.7 The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with GVSMVAMC and VHSO policy.

8.8 The Contractor shall not create or maintain any records containing any non-public GVSMVAMC information that are not specifically tied to or authorized by the contract.

8.9 The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

8.10 The GVSMVAMC and VHSO owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which

GVSMVAC and VHSO shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

8.11 Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. TMS (Talent Management System) course VA 4192704: “Records Management for Everyone” [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

9. Policy and Regulations:

9.1. Flow-down of requirements to subcontractors:

9.1.1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

9.1.2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

9.2. The Contractor is required to meet VHA performance and quality criteria and standards including, but not limited to, access, customer satisfaction, prevention index, chronic disease index and clinical guidelines. Performance and quality standards may change during the contract. New or revised quality/performance criteria or standards will be provided to the Contractor before implementation date and throughout the life of the contract through unilateral or bi-lateral modifications, as applicable. Copies of current VA and VHA publications can be located at http://www.va.gov/vhapublications/ or at http://www.va.gov/vapubs/. Compliance with mandated performance is required as a condition of this contract. Contractor shall comply with all relevant VA policies and procedures, including those related to quality, access, patient safety, and performance, including, but not limited to the policies and regulations set forth by the following regulating agencies: Joint Commission (TJC), Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CA), Federal Drug Administration (FDA), Centers for Disease Control (CDC), and Association for the Advancement of Blood & Biotherapies (AABB).

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