36C25718Q0330-00001000.docx

Statement of Work

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2.

AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE

OF PAGES

10A. MODIFICATION OF

CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV.

11/2016) is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITE M 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR

43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes r eference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS

ENTERED INTO

PURSUANT TO AUTHORITY OF:

D. OTHER

BY

Contractor

16C. DATE SIGNED

14.

DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME

AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS

OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 00001 674-18-3-034-0150 00504 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106 To all Offerors/Bidders

36C25718Q0330 03-08-2018

X X X 674-3680160-034-822300-2633 010022300 X The purpose of this amendment is to update Section E of the Statement of Work.

Mark Branum Contracting Officer

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Blood Products & Blood Services Reference Testing

2. Scope of Work: Supplier will obtain and test blood and blood components to meet standards set forth by the Food & Drug Association (FDA), American Association of Blood Bankers (AABB), and College of American Pathology (CAP). Components may include leukocyte-reduced red blood cells (LRBC), fresh frozen plasma (FFP), platelet apheresis (APLT), cryoprecipitate (CRYO), and other blood components as necessary to meet our veterans’ transfusion needs. Supplier will also provide reference testing services to find compatible blood products for patients if the CTVHCS blood bank is unable to successfully type and crossmatch units.

Supplier will provide transportation of blood products to Central Texas Veterans Healthcare.

3. Background: Blood Components are a critical need for a hospital that performs surgeries, has an Oncology Department, and an Emergency Department that may deal with trauma as well as acute and chronic illness. CTVHCS is a full-service hospital that provides all these services.

The period of performance will be detailed in the price/cost schedule. This information will be in the contract. No need to have it in the SOW.

B. GENERAL REQUIREMENTS

The Contractor shall provide shall provide all necessary supplies, equipment, and services required to deliver and rotate the stock of blood units at the Central Texas Veterans Health Care System (CTVHCS), 1901 Veterans Memorial Drive, Temple, Texas 76504.

By submitting an offer, offeror certifies that their blood center is currently licensed with the FDA and accredited by AABB. A copy of license and accreditation shall be submitted with the proposal.

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

1. All platelet apheresis products must be supplied as leuko-reduced.

2. All requests for fresh frozen plasma must be filled by fresh frozen plasma not frozen plasma or cryo-reduced fresh frozen plasma.

3. Blood units shall be delivered prior to the expiration date stated on each unit and certified that all units have been tested in accordance with the required mandates of the FDA and the AABB.

4. Procedures for obtaining, storage, shipping and delivery must conform to FDA and AABB requirements.

5. All units of blood shall be transported to the CTVHCS in Styrofoam mailing containers packed in ice. The Contractor shall provide containers which will be returned to the Contractor by CTVHCS.

6. The Contractor shall have a plan acceptable to CTVHCS for providing blood components to meet contract requirements in the event of a VA or other community disaster. The Contractor shall furnish a copy of this plan with its proposal.

7. Provide emergency contact information, fax information and on call protocols to ensure communications can be reliably transmitted to the Blood Bank Medical Director, and Blood Bank Laboratory staff. Changes to the emergency contact information should be routed through the Blood Center’s Hospital Services department

8. Response to disasters and emergencies:

In event of regional, local or Veterans Health Care System disasters or emergencies, re-allocation of the blood supply may be necessary. To this end, the Blood Center will establish and maintain an emergency availability program that will include specific parameters for communication and crisis management when product shortages dictate careful rationing of available product. These parameters will include but not be limited to communication protocols and inventory management protocols to ensure to the best of our ability that products are made appropriately available for critical patient needs. Upon determination by the Blood Center that such a condition exists in the community or at the Veterans Health Care System, the following procedure will be used.

a. The Blood Center shall:

· Notify facilities of need for re-distribution of products;

· Move products to the Center for re-allocation.

· Account for redistributed products and issue credits and/or invoices as indicated.

· Make reasonable effort to obtain product from outside sources as needed.

· With due diligence recruit donors and collect blood.

· The Blood Center will utilize emergency contact information provided by the Veterans Health Care System to notify the Veterans Health Care System of shortages, product recalls or other events that warrant management attention and review.

b. The Veterans Health Care System shall:

· Evaluate current inventory and, to the extent possible, release products for re-distribution in the event of a community disaster.

· Provide minimum emergency stock recommendations to facilitate communications during a crisis and/or stock shortage. This stock level must be reviewed at least once annually and approved by the Veterans Health Care System Blood Bank Medical Director and the Blood Center.

9. No charge will be made for blood returned to Contractor within seven (7) calendar days prior to the expiration date.

10. Types of Blood deliveries Regular Deliveries; two times per week Extra Deliveries; as requested by CTVHCS. (Other than regular two times per week deliveries) STAT Deliveries; as requested by CTVHCS. (Deliveries required within 2-3 hours after notification).

D.SCHEDULE FOR DELIVERABLES

Regular blood deliveries shall be made two times per week by the Contractor to CTVHCS. Units not used by CTVHCS will be returned to the Contractor as is mutually agreed upon by the Contractor and CTVHCS. Units will be shipped in accordance with AABB specifications.

E. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

If new FDA or AABB mandated requirements that do not exist at the time of this contract result in exceeding projected increases in pricing by 5% or more, Contractor reserves the right to submit an amended fee schedule. Any pricing increases necessitated by changes in federal testing requirements will be submitted in writing in accordance with Section 52.212-4, Contract Terms and Conditions, subsection c. This notice will include specific description of the FDA regulations and citations necessitating this change. Specific dollar increases will represent the Contractor’s cost to perform the test with no further mark-up.

F. GOVERNMENT RESPONSIBILITIES

1. After completion of all transfusions, the blood containers and tubing will be returned to Pathology and Laboratory Medicine Service, and documentation completed in accordance with Professional Service Memorandum No. 113.1

2. The Chief, Pathology and Laboratory Medicine Service, will ensure an accurate record keeping system is established within the service to provide for efficient management of blood and blood components for this contract.

3. CTVHCS will return for credit, within fifteen (15) calendar days of receipt, any unit which is rejected due to error in labeling or if product is of an unacceptable quality.

4. If contaminated blood is found, it will be returned to the Contractor. An experienced Blood Bank employee will make the decision to either accept or reject the unit of possible contaminated blood or blood component.

5. CTVHCS Blood Bank is under the direction of the Chief, Pathology and Laboratory Medicine Service. After award of a contract, a Contracting Officer’s Technical Representative (COTR) will be designated to monitor contractor performance.

6. Orders will be placed with the Contractor by telephone to expedite the ordering process.

7. CTVHCS will handle and store blood in accordance with FDA and AABB regulations. CTVHCS will allow annual inspection of its procedures and conditions for handling and storing blood products by the Contractor.

8. CTVHCS must return blood to the Contractor within seven (7) calendar days before the expiration date on the unit.

9. CTVHCS will comply with all FDA mandated follow-up/look back recommendations.

G. 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 contract, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the contract.

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 contract. No information shall be released by the contractor. Any request for information relating to this contract, 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 of the CO.

H. EVALUATION OF CONTRACTOR

The basis for selecting the contractor will be made on three main criteria in the following descending order of importance.

1. Safety. All blood and blood products must meet or exceed all AABB and FDA standards.

2. STAT deliveries. The blood supplier must be able to meet a minimum of 2-hour turnaround times on STAT deliveries to assure the best care for our patients.

3. Price. The third most important criteria for award of this contract is the lowest possible price.

Evaluation of these criteria will be made by the Blood Bank’s Fiscal Administrative Officer – Dondi Allison (or designee), Blood Bank Supervisor – Dionne Cook, P&LMS Chief Technologist – Debra King, and assigned Contract Specialist.

Attachment A to the Statement of Work

Schedule of Deliverables

Item

Leuko-reduced red blood cells (LRBC) Leuko-reduced platelet apheresis Fresh Frozen Plasma Cryoprecipitate (pools of 5)

Quantity

Delivery Date

IDIQ

IDIQ

IDIQ

Reference Testing (to include special treatment of specimen and/or blood units) Special Pick-up/Delivery

AS NEEDED

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