Attachment B SON Blood Bank Blood Products.pdf

Attachment

36C24824Q0003

Statement of Need

A. BACKGROUND

1. The North Florida/South Georgia Veterans Health System (NF/SG VHA) has an ongoing 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 proposal in accordance with all terms, conditions, provisions, specifications, and schedules of this solicitation and award contract.

2. 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 and 619 S. Marion St., Lake City, FL 32025 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.

B. PERIOD OF PERFORMANCE

1. This anticipated base contract period will be October 1, 2023, until September 30, 2024.

This request is for a base year plus to include four (4) one (1) year option periods.

2. The contractor shall be required to begin providing supplies as required on effective date of contract award.

C . S P E C I F IC A T IO NS

1. 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.

D. REQUIREMENTS

1. 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.

2. 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 21 days from date of collection if collected in CPD, 35 days from date of collection if collected in CPDA-1, or 42 days if AS-1 is used as an additive.

3. 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.

4. All Platelets will be tested for bacterial contamination and pathogen reduction with manufacturer instruction using FDA approved instrumentation and AABB approved methods. AABB guidelines shall be followed for plasma components to reduce the risk of TRALI. Other screening will be performed on cellular components when requested and/or required.

5. All Plasma for allogeneic transfusion should be from males, female who has not been pregnant, or female who has been tested since the most recent pregnancy and results interpreted ad Negative for HLA antibodies.

6. Control of blood inventory management shall be handled by the compatibility testing contractor.

7. All blood must be leukoreduced.

E. Packaging and Marking:

1. Blood shall be labeled as to A, B, O and Rh type. Type A Rh negative, A Rh positive, O Rh negative, and O 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.

2. All blood and blood components must use the bar code labels (ISBT-128) conforming to

International Council for Commonality in Blood Bank Automation, Inc. (ICCBBA) will be legible on all blood products.

3. Each shipment must be properly packaged, labeled, and accompanied by an itemized shipping list in accordance with this solicitation.

4. Packaging must be of protective quality to ensure that the product is undamaged during handling and maintains the proper temperature during transportation.

F. Reporting Requirements:

1. 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.

G. Deliveries and Performance:

1. 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, with STAT requests delivered within one (1) hour, ASAP requests delivered within (2) hours and Routine requests delivered within eight (8) 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. Empty containers, blood, and equipment being returned for credit shall be returned at contractor's expense.

2. All blood picked up at the Veterans Hospital 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.

3. Compatibility control of blood inventory management shall be handled by the compatibility testing contractor.

4. The contractor must be able to provide 100% of the NF/SG VA blood supply needs as well as Reference Lab and Therapeutic Services.

H. Ordering:

1. Control of blood inventory management shall be handled by the compatibility testing contractor.

2. ASAP- Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

3. STAT-A need for blood products so acute that a patient’s life could be jeopardized if the request for blood products is unfulfilled. STAT orders must be delivered within sixty (60) minutes or less Additional emergency requirements shall be placed and the shipper shall arrange for delivery in one hour or less (including orders during evenings and nights).

I. Interstate Shipment:

1. If interstate shipment of blood or blood components 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.

J. SPECIALIZED SERVICES:

1. Contractor shall provide consultation service, under the direction of the contractor’s Medical

Director(s) to aid in the identification of difficult irregular antibodies, problem crossmatches and any such matters. Contractor shall provide in house Therapeutic Phlebotomy Services, and other such services requested by the hospital. The contracting blood bank shall investigate all donors implicated in Transfusion Related Acute Lung Injury (TRALI) after notification by the VA hospital.

K. REFERENCE LABORATORY SERVICES

1. Reference services must be available twenty-four (24) hours per day, seven (7) days per week, and three hundred and sixty-five (365) days per year, including federal holidays.

2. 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:

VAMC, GAINESVILLE, FL

McBride, Jason

Scheuerer, Paula

Tiedemann, Erika

Santiago, Edgardo

Santiago, Yamira

Colon-Ortiz, Marilissa

Charles, Yanique

Perez, Lisa

Bonano-Vergara, Lissette

VAMC, LAKE CITY, FL

Hagler, Janette

Horne, Douglas

Rivera, Christa

Fritz, Todd

Lampp, Nathan

Watson, Pamela

Davis, Sandra

Galletta, Stacy

Cothran, Andrea Gomez-Mendez, Merlinda

L. THERAPEUTIC PHLEBOTOMY SERVICES

1. The contractor agrees to provide in-house therapeutic services as needed when such physician’s orders are received. Procedures must be available seven days a week and must be provided within a 24 period of the request for regularly scheduled cases. Emergency/STAT response time shall be within 4 hours once a patient and products are ready. The contractor warrants that all therapeutic services shall be provided by qualified and experienced personnel who shall be

Registered Nurses or Licensed Practical Nurses.

2. The contractor shall provide for all equipment and disposable necessary to accomplish the therapeutic services procedures once vascular access has been stablished by VA personnel and comply with the medical center’s regulations for disposal of such supplies and waste products.

If blood components or albumin are required, they will be provided by the VA. Portable equipment allows Apheresis Nurses to perform therapeutic procedures at the patient’s bedside.

3. Documentation of the Therapeutic procedure is provided by the contractor. Documentation should be entered in the patient’s chart by VA staff. The VA medical staff will provide

Quintero, Luis

Dinh, Bao

Gobezie, Shimelis consultation services as part of the procedure. The VA medical staff will formulate a therapeutic plan including volumes to be exchanged or treated, replacement solutions, frequency and number of procedures, lab tests to monitor response, and care for any adverse event directly related to the therapeutic procedures. The VA will maintain and retain responsibility for any patient undergoing therapeutic procedures.

M. TJC, AABB, VHA (VETERANS HEALTH ADMINISTRATION) AND OTHER

STANDARDS:

1. The contractor shall notify the VA Contracting Officer immediately at the North Florida/South

Georgia Veterans Healthcare System, 1601 SW Archer Rd., Gainesville, Florida 32608 (telephone

no. (850) 559-2410 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 un-accredited entity or person shall perform services under this contract. Any change in status is grounds for immediate termination.

2. The contractor shall immediately notify the Contracting Officer (90C), North Florida/South

Georgia Veterans Healthcare System, 1601 SW Archer Rd., Gainesville, Florida 32608 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.

3. 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 practitioners’ 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.

4. The contractor shall perform the required work in accordance with The Joint Commission (TJC), AABB, OSHA, VHA HIPAA and/or any other regulatory standards. The contractor shall comply with all annual updates as issued.

5. 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.

6. 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.

7. The services specified in the Schedule of Services may be changed by written modification to this contract. VA Contracting Officer will prepare the modification.

8. 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.

9. HIPAA: Contractor shall comply with the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and with the provision of other appropriate federal laws, rule and regulations.

10. Qualifications: Proposals 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.

1. 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.

N. Certification:

1. The offeror certifies that he shall comply with the requirements outlined with respect to donors, containers, delivery, etc.

O. Blood Donation:

1. 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.

P. Donor List:

1. 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.

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

Q. Inspection of Contractor’s Facility:

1. 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.

R. Qualifications:

1. 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.

2. 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

S. Personnel Policy:

1. The Contractor shall assume full responsibility for the protection of its personnel furnishing services under this contract, in accordance with the personnel policy of the Contractor, such as providing worker's compensation, professional liability insurance, health examinations, income tax withholding, and social security payments. The parties agree that the contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose.

T. Confidentiality:

1. 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.

2. 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.

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

U. Invoicing, Payments and Credit:

1. Charges should be inclusive of all transportation charges as defined in Deliveries and

Performance, except those charges incurred and authorized by Path & Lab Service. Additional charges over the allowed deliveries will appear on a monthly, primary invoice.

2. All charges for blood and blood components shall be based on the contracted blood bank’s posted fee schedule for the respective calendar year. Calendar year pricing may override the fiscal year projected price of the previous calendar year.

3. All charges for Reference Lab and Therapeutic Services shall be based on the contracted blood bank’s posted fee schedule for the respective calendar year.

4. All unsatisfactory units (broken Fresh Frozen Plasma (FFP), clots in red cell units, etc.) shall be returned and full credit given to the VA. Full credit will be provided for returned units.

5. All invoices will be paid monthly in arrears upon receipt of invoice. Each invoice shall indicate the month in which the items were delivered and the appropriate obligation number.

6. VA will review the invoices and match them against VA bill validation report to verify that services were performed in accordance with solicitation. 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.

V. Other /Applicable Policies and Regulations:

1. The Contractor shall perform in accordance with policies and procedures set forth in VHA

Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures. the handbook can be located at the following web address: https://govtribe.com/file/government-file/vha-handbook-

1106-dot-01-dot-pdf

2. HHS/OIG: To ensure that the individuals performing under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Service – Office of Inspector General, List of excluded individuals/entities on the OIG Website

(www.hhs.gov/oig) for each person providing services under this contract. Further the contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract the

Contractor is prohibited from using any individual or business listed on the List of Excluded

Individuals/Entities. “Contractor shall provide health care to patients seeking such care from or through VA. As such, contractor is considered part of the Department health activity for purposes of the following statues and the VA regulations implementing these statues: the Privacy Act, 5.U.S.C. § 552a, and 38 U.S.C. §s 5701, 7705 and 7332. Contractor and its employees may have access to VA patient medical records to the extent necessary for the contract or to perform this contract. Notwithstanding any other provision of this contract, contractor and its employees shall disclose patient treatment records only pursuant to explicit disclosure authority for VA.

Contractor and its employees are subject to the penalties and liabilities provided statutes and regulations for unauthorized disclosures of such records and their contents.” “Records created by the contractor in the course of treating VA patients under this agreement are the property of the

VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.” Upon the expiration of this contract or termination of the https://govtribe.com/file/government-file/vha-handbook-1106-dot-01-dot-pdf https://govtribe.com/file/government-file/vha-handbook-1106-dot-01-dot-pdf http://www.hhs.gov/oig contract, the contractor shall promptly provide the VA with the individually identified VA patient treatment records.”

3. HIPAA COMPLIANCE: “Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). A business associate agreement is not required in this case.

W. CONTRACTING OFFICER REPRESENTATIVE (COR):

1. All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation, authorizing the COR at the commencement of the term of this agreement. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. The COR will be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

X. SERVICES CHARGES TO VA BENEFICIARIES:

1. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the contractor even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.