P01 - Statement of Work - Blood and Blood Products for North Texas VA.docx

STATEMENT OF WORK

Blood and Blood Products P&LMS, VA North Texas Health Care System (VANTHCS)

The purpose of this contract is to provide safe, quality blood products to, and therapeutic phlebotomies for, Veteran patients. Pricing includes all labor, materials, equipment and supplies necessary to provide the products or perform the services.

GROUP I - WEEKLY ESTIMATED DELIVERY REQUIREMENTS:

Quantities listed are estimated weekly totals:

Estimated quantities shown below are for annual requirements.

GROUP II – ESTIMATED YEARLY REQUIREMENTS:

GROUP III – SERVICES (ESTIMATED) TO BE PROVIDED ANNUALLY:

*Anticipating a 5% per year fee increase over the next five years to keep pace with labor and supply costs.

1. Contractor shall furnish human blood products and services FOB Destination to the VA North Texas Health Care System, 4500 S. Lancaster Road, Dallas, TX 75216 during the period of performance.

2. Period of Performance:

Base Period: 12 Months, May 1, 2027, through April 30, 2028 Option Period 1: 12 Months, May 1, 2028, through April 30, 2029 Pricing Period 2: 12 Months, May 1, 2029, through April 30, 2030 Pricing Period 3: 12 Months, May 1, 2030, through April 30, 2031 Pricing Period 4: 12 Months, May 1, 2031, through April 30, 2032

3. Prompt written notification shall be made by the Contractor to the VA North Texas Health Care System (VANTHCS) Transfusion Medicine Unit personnel of autologous and directed blood donations drawn on the Contractor's premises not passing all required testing.

4. Donor Requirements:

a. The Contractor shall comply with standard donor record keeping procedures on all delivered components and maintain such records according to AABB and Food and Drug Administration (FDA) guidelines. There is no requirement to exchange such information with VANTHCS under this contract.

b. Donor selection must be in accordance with criteria established by the FDA and AABB.

5. Blood Requirements:

a. All blood products must meet AABB and FDA standards.

b. All blood supplied will be free of gross hemolysis, excessive lipemia and clots.

c. Requests for fresh frozen plasma must be filled by fresh frozen plasma or plasma, frozen less than 24 hours. Frozen Plasma, Cryoreduced will not be acceptable alternatives unless requested by the VANTHCS.

d. Paid donors shall not be used for furnishing blood products under this contract. "Paid" as used this specification means receipt of any compensation by the donor that violates AABB or FDA guidelines for voluntary donation.

e. All red cell units supplied must be leukocytes reduced and must have a reasonable time remaining before expiration.

f. Platelet products must be Platelets, Pheresis Leukocytes Reduced and must be able to be used when delivered. Random donor platelets will not be acceptable alternatives unless requested or authorized by the VANTHCS TMU personnel.

g. Cryoprecipitate must be frozen in pools of 5 donors. Single random donor cryoprecipitate units will not be acceptable alternatives unless requested or authorized by the VANTHCS TMU personnel.

h. VANTHCS TMU personnel reserve the right to accept units with shorter dating if deemed appropriate.

i. Red blood cell units containing unexpected red cell antibodies will not be accepted.

j. Platelet products from donors on aspirin containing medications will not be accepted unless mutually agreed upon in advance.

6. Only blood suppliers and blood bank reference laboratories that are fully licensed/accredited by CLIA, AABB, and FDA and be actively engaged in providing the specific blood products and services outlined in this solicitation will be considered.

7. Contractor will supply all labor, equipment, and materials required to perform procedures/services as stated herein.

8. VANTHCS TMU personnel will place orders by telephone, online, or fax for quantities and items as needed. VANTHCS TMU personnel will order special order items by FAX correspondence. The TMU personnel will state the time required for delivery. Multiple deliveries may be required in the same day.

9. Contractor’s distribution location should be local to VANTHCS, Dallas facility (within 50 miles) to meet stat, urgent, or emergency blood product requests.

10. All blood products shall be packed according to AABB and FDA requirements. The Contractor will furnish appropriate containers for shipment of blood products at the Contractor's expense and deliver products to VANTHCS at no charge. Empty containers and equipment will be returned at the Contractor's expense.

11. Unused red blood cell products shipped with less than 5 days remaining and unused platelet products with less than 24-hour expiration time may be returned/claimed for full credit at Contractor’s expense. All frozen products discovered broken during thawing may be claimed for full credit.

12. The contractor shall provide Therapeutic Phlebotomy Donation Services for treatment of eligible Veterans and other eligible beneficiaries from Monday through Friday at multiple locations throughout North Texas area to make access to health care easier. Donations eligible for recipients shall be provided at no charge.

13. The Contractor must provide the VANTHCS with consultation services under the direction of a physician who is qualified in Blood Banking/Transfusion Medicine. The reference laboratory must be available 24 hours a day, including weekends and holidays at no additional expense beyond the regular reference laboratory fees. The reference laboratory must meet proficiency and competency requirements as set forth by AABB and FDA.

14. The Contractor must provide VANTHCS a contingency plan to ensure adequate and safe blood supply. The Contractor’s plan should include the means for maintaining VANTHCS’ minimum inventory, requirements for notification when a donor or components are found to be seropositive, and redistribution of components for disaster or emergency need, which could include obtaining needed components by drawing donors or by agreement with another facility.

15. The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or Contractor, may continue them.

16. Security Requirements: VA Protected Health Information is provided to the vendor under this contract. This contract is to enable a HIPAA Covered Entity to provide clinical services on behalf of VA. The patient’s consent is not required (1605.1P24). The vendor is required to secure the PHI as required by HIPAA. The C&A requirements do not apply, and a Security Accreditation Package is not required.

SECTION B REQUIREMENTS/SPECIFICATIONS:

1. Contractor shall furnish human blood products and services FOB Destination to the VA North Texas Health Care System, 4500 S. Lancaster Road, Dallas, TX 75216 in such quantities and at such times as may be required for the period May 1, 2027 (or date of award if later) through April 30, 2032 (1 year base period); in accordance with the terms and conditions listed herein.

1. VANTHCS TMU personnel will place orders on an as needed basis via telephone, online or fax. The quantity, group and Rh of the items ordered will be specified at the time of order. Special order items/tests will be requested via fax. Multiple deliveries may be needed on the same day.

1. VA North Texas Health Care System (VANTHCS) makes no guarantee as to what volume of products or tests, if any, the contractor may receive. VANTHCS reserves the right to request additional products or services other than those listed within. If additional tests are added, either by the contractor or VANTHCS, the contractor shall provide the methodology and ranges for results on any tests that are requested by representatives of VANTHCS.

1. Donor Requirements:

20. The Contractor shall comply with standard donor record keeping procedures on all delivered components and maintain such records according to AABB and Food and Drug Administration (FDA) guidelines. There is no requirement to exchange such information with VANTHCS under this contract.

20. Donor selection must be in accordance with criteria established by the FDA and AABB.

20. Prompt written notification shall be made by the Contractor to VANTHCS of autologous and directed blood donations drawn on the Contractor’s premises not passing all required testing.

1. Blood Requirements:

a. All blood products must meet AABB and FDA standards.

b. All blood supplied will be free of gross hemolysis, excessive lipemia and clots.

c. Requests for fresh frozen plasma must be filled by fresh frozen plasma or plasma, frozen less than 24 hours. Frozen Plasma, Cryoreduced will not be acceptable alternatives unless requested by the VANTHCS.

d. Paid donors shall not be used for furnishing blood produces under this contract. "Paid" as used this specification means receipt of any compensation by the donor that violates AABB or FDA guidelines for voluntary donation.

e. All red cell units supplied must be leukocytes reduced and must have at least 21 days remaining before expiration.

f. Platelet products must be Platelets, Pheresis Leukocytes Reduced and must be less than 72 hours old when delivered. Random donor platelets will not be acceptable alternatives unless requested or authorized by the VANTHCS TMU personnel.

g. Cryoprecipitate must be frozen in pools of 5 donors. Single random donor cryoprecipitate units will not be acceptable alternatives unless requested or authorized by the VANTHCS TMU personnel.

h. VANTHCS TMU personnel reserve the right to accept units with shorter dating if deemed appropriate.

i. Red blood cell units containing unexpected red cell antibodies will not be accepted.

j. Platelet products from donors on aspirin containing medications will not be accepted unless mutually agreed upon in advance.

1. Packing and Delivery:

a. Blood products shall be delivered at the time specified when the order is placed. The Contractor will furnish appropriate containers for shipment of blood products at the Contractor's expense. Empty containers and equipment will be returned at the Contractor's expense.

b. Deliveries shall be made to the VA North Texas Health Care System (VANTHCS), 4500 S. Lancaster Rd, Dallas, TX 75216 to the Transfusion Medicine Unit in Room 1B-306. The deliveries shall be made 24 hours a day, including holidays and weekends as requested. More than one delivery may be required in a 24-hour timeframe. The cost of delivery will be borne by the Contractor.

c. Contractor’s distribution facility should be local to the VANTHC Dallas facility (within 50 miles) to meet stat, urgent, or emergency blood product requests.

1. Credits:

a. Unused red blood cell products shipped with less than 5 days remaining may be returned/ claimed for full credit at Contractor's expense.

b. Unused platelet products with less than a 24-hour expiration time may be returned/claimed for full credit at Contractor's expense.

c. Frozen plasma units discovered broken during thawing may be claimed for full credit.

1. The contractor shall provide Therapeutic Phlebotomy Donation Services for treatment of eligible Veterans and other eligible beneficiaries from Monday through Friday at multiple locations throughout North Texas area to make access to health care easier. Donations eligible for recipients shall be provided at no charge.

1. The Contractor must provide the VANTHCS with consultation services under the direction of a physician who is qualified in Blood Banking/Transfusion Medicine.

1. Contractor shall provide laboratory services to include analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. These procedures/tests shall be performed to the satisfaction of VA North Texas Health Care System (VANTHCS) Pathology & Laboratory Medicine Service, Chief of Staff, and the Contracting Officer’s Representative (COR).

1. The reference laboratory must be available 24 hours a day, including weekends and holidays at no additional expense beyond the regular reference laboratory fees. The reference laboratory must meet proficiency and competency requirements as set forth by AABB and FDA.

1. Upon reasonable notice to the Contractor, Contractor shall permit site visits by the VANTHCS ("Audits"). Such audits shall include the opportunity for VANTHCS to view the Contractor's staff performing the services and review documentation relating to the services, including billing and records related thereto, rendered pursuant to this Agreement. The VANTHCS also reserves the right to terminate the contract if the Contractor, during the term of the contract fails to meet an acceptable level of performance in carrying out contract requirements. The Contractor must provide VANTHCS a contingency plan to ensure adequate and safe blood supply. The Contractor’s plan should include the means for maintaining VANTHCS’ minimum inventory, requirements for notification when a donor or components are found to be seropositive, and redistribution of components for disaster or emergency need, which could include obtaining needed components by drawing donors or by agreement with another facility.

1. Contractors have the right to inspect VA storage facilities to assure quality control over returned blood products.

1. Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those blood products and services requested, and only for valid patients of VANTHCS.

1. Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

1. Health Insurance Portability and Accountability Act:

a. Contractors shall take reasonable measures to ensure patient privacy and confidentiality. The contract service providers herein agree to take all reasonable precautions to safeguard patient information from unauthorized access or modification, in both electronic and hard-copy formats. This includes not only electronic security measures such as “strong” user passwords on computer systems, but also physical barriers to prevent unauthorized use of computer work-stations; that hard copy patient files are in secured lockable areas, that files are in lockable cabinets, that the cabinets can in fact be locked, i.e., keys are available, and the locking mechanisms work properly. This precaution also includes the proper transfer of patient information via electronic means, such as faxing or system to system transmission.

b. That no patient information of any type shall be given to outside parties, agencies or organizations of any type without the expressed written consent of the patient and the VA North Texas Health Care System, and only in capacities directly related to the provision of the services contracted in this instrument.

c. That only the minimum necessary patient information is used to provide appropriate service to the correct patient.

d. Contractors require no access to any VA information system. There will be supervised access when the contractor is physically present.

e. No VA data of any type shall be transferred from the VA.

1. The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to (1) furnish phase-in training and (2) exercise its best efforts and cooperation to affect an orderly and efficient transition to a successor.