36C24818Q0809-002.docx

I. INTRODUCTION

The North Florida/South Georgia Veterans Health System (NF/SG VHA) has a requirement for the delivery of blood and blood products provided by a registered and/or licensed blood bank entity. It is VA's intention to solicit quotes in accordance with all terms, conditions, provisions, specifications, and schedules of this solicitation and award a firm fixed price, 1DIQ contract.

The Contractor in accordance with the terms and conditions stated herein to furnish to and/or at the NF/SG VHS, 1601 SW Archer Rd., Gainesville, FL 32608 for the supplies at the prices specified in Schedule of Services and Prices of this contract. The initial listing of supplies to be furnished is identified in the Schedule of Services and Prices, and Statement of Work.

Quotes shall be considered only from offerors whose blood bank is currently registered and/or licensed with the Food and Drug Administration (FDA), Department of Health, Education and Welfare pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, 21 USC Section 260.

II. PERIOD OF PERFORMANCE

The anticipated contract period of performance will be 1 October 2018 through 30 September 2019 with four (4) one (1) year options. The contractor shall be required to begin providing supplies as required on effective date of contract award.

III. SPECIFICATIONS

Packed Red Blood Cells and blood components, in suitable containers, shall be delivered F.O.B. destination within consignee's premises to the North Florida/South Georgia Veterans Health System Veterans' Hospital, for the period one year from date of contract award in such quantities and at such times as may be required in accordance with all terms, conditions, provisions and the Schedule of this offer. The Department of Veterans Affairs (VA) will arrange transportation of emergency requirements (when requested shipping is on other than scheduled ship dates) of items listed in the schedule.

IV. REQUIREMENTS

Collection, Process and Typing of Blood: Blood shall be typed for ABO and Rh antigens and screened for red cell antibodies in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks (AABB). A sample of blood from each donation shall be tested for Anti-HIV-1/2, Anti-HCV, HbsAg, Anti-HTLV-I/II, Anti-HBc, Syphilis, HIV-1/HCV RNA, West Nile Virus and ZIKA virus.

All blood shall be collected in a closed system under aseptic conditions and shall be processed in appropriate solutions and the container so labeled. The label shall also bear the expiration date of the contents which shall not exceed twenty-one (21) days from date of collection if collected in CPD, thirty-five (35) days from date of collection if collected in CPDA-1, or forty-two (42) days if AS-1 is used as an additive.

All blood supplied shall be grossly free of hemolysis, excessive chyle and clots. All unsatisfactory units (broken FFP, clots in red cells, etc.) shall be returned and full credit given to VA. Expired units shall be returned and full credit given to VA, except when units have been irradiated.

Blood shall be labeled as to A, B, 0 and Rh type. Type A Rh negative, A Rh positive, 0 Rh negative, and 0 Rh positive shall be drawn from donor not more than five (5) days before date on which purchase order is filled. Types such as AB Rh positive, AB Rh negative, B Rh negative and B Rh positive shall be supplied as fresh as possible but not over fifteen (15) days old if blood is collected in CPDA-l. These time limits shall be adjusted if a system for exchange on credit is provided which minimizes or precludes losses due to outdating.

When platelets shall be separated from donor blood, the blood shall be at room temperature up to eight (8) hours. If platelets are not separated, the blood shall be refrigerated immediately after bleeding between 1° and 6° C with fluctuation of no more than 2° C within this range. Freezing shall be avoided at all times. If public transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold the blood at 1-10° C if it has been pre-cooled. If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10° C, preferably, 1-6° while in transit. Control of blood inventory management shall be handled by the compatibility testing contractor.

Prior to award the offeror shall submit proof that he holds an unrevoked U.S. License which is issued by the Director, Bureau of Biologics, Food and Drug Administration (FDA) under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood.

The contractor shall certify that full compliance with the requirements outlined with respect to donors, containers, delivery, etc. during the duration of the contract.

The contractor shall provide the VA only with 100% "volunteer donor" blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. Definition of a "volunteer donor" - A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment In accordance with 21 CFR 610.46, 610.47 & 610.48, the VA Transfusion Service shall be notified of any subsequent positive viral donor test results discovered by the Contractor. The VA Transfusion Service will perform "Lookback" notification of all positive viral testing, by notifying the recipient’s attending physician.

The Contractor shall provide VA with a primary and alternate Point of Contact, to include properly working phone numbers, to ensure emergency situations are addressed in a timely manner. The blood shall be delivered as specified within twenty-four (24) hours following request therefore. Emergency requirements are to be available twenty-four (24) hours a day and seven (7) days a week, for pickup within 30-60 minutes from the time requested or to be delivered at the expense of VA. Empty containers, blood, and equipment being returned for credit shall be returned at contractor's expense.

All blood picked up at any North Florida/South Georgia Veterans Medical Center under this contract shall be properly packed and insulated in such a way as to ensure that the blood shall remain within a temperature of 1-10° C, during transport between contractor's place of business and the NF/SG VHS.

Compatibility control of blood inventory management shall be handled by the compatibility testing contractor. The contractor shall provide 100% of the NF/SG VA blood supple needs as well as Reference Lab and Therapeutic Services. The resources specified in this solicitation shall be furnished to the VA by the contractor when requested by means of an individual written request which has been authorized by Chief, Pathology and Laboratory Medicine Service or his designees as listed below for each VAMC:

Attachment B 36C24818Q0809

VAMC, GAINESVILLE, FL Chun, Susan Dibiasio, Beth A.

Rodriguez, Cesar Santiago, Edgardo Tiedemann, Erika Tweedy, Sherrie Trujillo, Rebeca Martinez, Elida

Odiot, Isabel Quintero, Luis A.

McBride, Jason Traxler Stephanie Valles, Sara Bonano, Lissette Jimenez, Joseph Fritz, Todd Todd, Matthew VAMC, LAKE CITY, FL (Reference Only) Dooley, Cynthia Haase, Richard T. Quiñones, Luisa Broz, Kimberly Evans, Jo Lynn Melendez, Elena Lampp, Nathan

Davis, Sandra Gonzalez, Dolly Ann Horne, Douglas Haggler, Janette F.

Wagers, Stephanie Ojeda-Meals, Geralda Besnon, Audrey Miller, Emerald Cothran, Andrea Gomez-Mendez, Merlinda Jo Lynn Evans

V. JCAHO, VHA (VETERANS HEALTH ADMINISTRATION) AND OTHER STANDARDS:

The contractor shall notify the VA Contracting Officer immediately at the North Florida/South Georgia Veterans Healthcare System, 301 E. University Ave Ste #170, Gainesville, Florida 32601 of any change in the licensure, or status as non-excluded or sanctioned by HHS (Health & Human Services) Office of Inspector General of any personnel performing the services covered by the contract. No unlicensed, non- Medicare approved, uncertified or accredited entity or person shall perform services under this contract. Any change in status is grounds for immediate termination.

The contractor shall immediately notify the Contracting Officer (90C), North Florida/South Georgia Veterans Healthcare System, 301 E. University Ave Ste #170, Gainesville, Florida 32601 of any merger, acquisition, or affiliation agreement; any legal or governmental action initiated against the contractor for professional negligence, violation of law, bankruptcy, lapse or material change in liability insurance coverage, any other problem or situation that might impair the ability of contractor (offeror) to carry out its obligations under the contract. Any change in status is grounds for immediate termination.

The contractor represents and warrants that it is in compliance with Medicare, Medicaid and any other related Federal or State Statutes, regulations, rules or policies and that neither they nor their agents, officers, employees, independent practitioner’s assignees or successors in interest are excluded from participation in the Medicare, Medicaid or related federal or state programs. Further, contractor shall immediately notify the Contracting Officer of the exclusion from such programs of any of its agents, officers, employees, independent practitioner's assignees or successors in interest. Such exclusions shall be grounds for immediate termination of the contract.

The contractor shall perform the required work in accordance with Joint Commission Accreditation of Health Care Organizations (JCAHO), OSHA, VHA HIPAA and/or any other regulatory standards. The contractor shall comply with all annual updates as issued.

The contractor shall conform to all issues addressed in the VA Medical Staff By-laws and the VA Medical Center Memorandums pertaining to delivery of services.

Contractor shall maintain the minimum acceptable service, reporting systems and quality control as specified herein. Failure to comply with the specified terms and conditions and/or adverse reports from external monitoring agencies, which indicate poor quality of care, may be grounds for termination of the contract. Immediate (within 24 hours) notification must be given to VA regarding adverse reports and action by a regulatory agency.

The contractor shall furnish the services specified in the Schedule of Services to this contract to VA when authorized by VA Chief of Staff or designee.

Donor List:

The Contractor shall maintain readily available blood donor lists including names, addresses and social security numbers. Such lists shall indicate whether and on what date blood of a particular donor was furnished to the Department of Veterans Affairs under this contract period.

Donor selection shall be in accordance with criteria established by the FDA and/or the AABB.

VI. INSPECTION OF OFFEROR'S FACILITIES:

The Government reserves the right to thoroughly inspect and investigate the Contractor's establishment and facilities and other qualifications, if it should be administratively determined as lacking in any of the essentials necessary to assure acceptable standards of performance.

VII. QUALIFICATIONS:

Contractor shall be financially responsible and able to show evidence of their responsibility, ability, experience, equipment, facilities, and personnel directly employed or supervised by them to render prompt and satisfactory service in the volume required for all items under this contract. By performing this requirement, the Contractor is certifying that he/she shall meet all requirements of Federal, State, or local laws, codes, and/or regulations regarding the operation of this type of service.

Any sub-contractor utilized by the contractor for the provision of services required under this contract shall meet the same qualifications specified herein for the contractor. The contractor shall obtain approval from the Contracting Officer for any sub-contractor to be utilized for the provision of services required under this contract. A subcontracting plan is required in accordance with Federal Acquisition Regulation Part 19.7.

VIII. CONFIDENTIALITY:

VA will provide the contractor with access to pertinent patient medical information, within the existing privacy rules and regulations. Contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

This contract will be subject to the Privacy Act of 1974. Federal Acquisition Regulations 52.224-1 Privacy Act Notification and 52.224-2 Privacy Act are provided in full text in the Addendum to FAR clause 52.212-4. The Contractor is not authorized to release any medical record information. The VA is the sole entity authorized to release this information upon written request from the patient.

Contractor and it’s representatives shall comply with the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and with the provision of other appropriate federal, state and local laws, rules and regulations.

The Contracting Officer's Representative (COR) will forward any incidents of Contractor noncompliance, immediately to the Contracting Officer.

IX. ORDERING, PAYMENTS AND INVOICING:

VA will review the invoices and match them against VA bill validation report to verify that services were performed in accordance with contract. VA will notify the contractor of invoice discrepancies. Upon the resolution of the discrepancies, contractor shall submit a revised invoice; VA will verify revised invoice and make payment accordingly.

Ordering and control of blood inventory management shall be handled by the compatibility testing contractor. Additional emergency requirements shall be placed and the shipper shall arrange for delivery in one hour or less (including orders during evenings and nights). If outside delivery (taxi) is used, VA will provide payment for the transportation in the instances of emergency requirements shipped other than scheduled ship dates.

If interstate shipment of blood or blood component is involved, the Contractor shall submit a statement that such approval has been authorized under Section 251 of the Public Health Service Act, as amended 42, USC Section 262.