Combined Synopsis and Solicitation.pdf

Combined Synopsis-Solicitation for Commercial Items

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 1 of 10 Original Date: 10/12/17 Revision 04 Date: 06/10/20

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-01.

This solicitation is set-aside for Full and Open competition.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621991, with a small business size standard of $35 Million.

The FSC/PSC is 6515.

The Martinsburg VAMC is seeking to purchase Blood and Blood products.

All interested companies shall provide quotations for the following:

A. BLOOD AND BLOOD COMPONENTS:

1. The contractor(s) shall furnish the following Food and Drug Administration (FDA) approved blood, blood components and services as described herein to the Martinsburg VAMC facility.

2. A projection of the estimated quantities of products and services required for the next five

(5) years is listed below.

Martinsburg VAMC Estimated Volumes Estimated Quantity

PRODUCT FEES

Red Blood Cells(Human) Random Type, Leukodepleted 850

Platelet Pheresis, Leudodepleted 60 Cryoprecipitated AHF 10 Cryoprecipitated, Pooled (5 units /pool) 1

FP24 150

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3. Emergency Delivery Fee: Contractor will provide pricing for such deliveries. Price submitted will locked for the period of that year award.

4. All laboratory tests will be performed by a laboratory accredited by America Association of Blood Banks (AABB) and licensed and/or registered by the Food and Drug Administration (FDA). This is an AABB standard; therefor proof of accreditation/ certification/license shall be submitted with quote.

B. LABORATORY SERVICES:

Martinsburg VAMC Estimated Volumes Estimated Quantity

IRL TESTING FEES-PRODUCT RELATED

Red cell antigen Neg 1 Ag. Per unit 20 Red cell antigen Neg 2 Ag. Per unit 10 Red cell antigen Neg 3 Ag. Per unit 3 Red cell antigen Neg 4 Ag. Per unit 2 Red cell antigen Neg 5 Ag. Per unit 1 Antigen type per antigen 20 IRL TESTING FEES- Sample Related ABO Type 2 Rh Type 2 Rh Phenotype complete 5 RBC Ag, other than ABO or D each 15 DAT, Each antisera 9 Elution, each 3 Antibody Screen, each media 10 Ab ID/each panel & media 10 Pre-treatment with enzymes, per cell 3 Pre-treatment chem./drugs 10 Adsorption 2 Titer, Indirect 2 Washing an SDP product 2 Irradiation of an SPD product 2

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II. SPECIFICATION/STATEMENT OF WORK

A. The contractor shall have all licenses, permits, accreditation and certificates required by local, state and federal laws to include requirements, regulations, recommendations, standards, specifications, guidelines, and directives of the Food & Drug Administration, the U.S. Public Health Service, American Association of Blood Banks, and Joint Commission on Accreditation of Healthcare Organizations. In the event of any conflict between the Regulations, U.S. law shall be given priority.

B. All containers and solutions used for the collection, preservation, and storage of blood samples shall meet applicable FDA regulations. Contractor shall submit proof that they hold an un-revoked US Biologics License which is issued by the Department of Health and Human Services Food and Drug Administration as a source/manufacturer of whole blood. This is an AABB standard therefore proof shall be submitted with offer.

C. All laboratory tests shall be performed by a laboratory accredited by American

Association of Blood Banks (AABB) and licensed and/or registered by the Food and Drug Administration (FDA). Proof of accreditation/certification/license shall be submitted with offer.

D. The contractor shall ensure that all contracted personnel (Medical Technologists, Medical

Laboratory Technicians, and Couriers) have appropriate certification/licenses and annual HIPAA compliant training required by the state or the accreditation agencies of the contractor (such as current and valid licenses and/or certifications).

E. All blood and blood components (frozen, room temperature and refrigerated) shall be collected from volunteer donors and shall be processed, stored and transported according to FDA and AABB regulations. Blood and blood components shall be collected in a closed system under aseptic conditions. It shall be processed in appropriate solutions. The container shall be labeled in accordance to regulations. Additionally, all blood shall be free of gross hemolysis, lipemia and/or clots.

F. Components and all reagents used for required tests on blood samples shall meet applicable FDA and AABB regulations. Donor blood shall be tested at a minimum for ABO, Rh, tests for unexpected antibodies, HbsAg, Anti- HBc, Anti-HCV, Anti-HIV-1, Anti-HIV-2, HIV-1 Ag, Anti-HTLV-1 and HTLV-2, WNV RNA and Chagas’ disease, and a serologic test for syphilis in accordance with AABB standards. Additional testing and/or follow-up testing may be implemented as the need arises or as required by the FDA and/or per AABB standards. The above tests, to prevent disease transmission, shall be negative except for Autologous blood.

G. The contractor will provide the requirements, special collection forms and the collection of Autologous and directed donor units at their collection centers for the proposed facility.

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H. Immediately after collection, the blood shall be refrigerated between 1 and 6 degrees Celsius with fluctuation of no more than 2 degrees Celsius 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 degrees Celsius 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 the 1-10 degrees Celsius, preferable 1-6 degrees Celsius while in transit.

I. Contractor will comply with the following: Contractor will maintain blood donor listings including names, addresses, Social Security numbers of the donors, and the date the donor blood or blood component was furnished to the facility. The Government understands and agrees that blood donor lists are confidential, and the contractor will not release such lists to the Government.

J. The contractor will test for bacterial contamination in platelets and provide twenty-four

(24) hour, seven (7) days per week automatic notifications to the facility via phone.

Contractor will state current method of testing for bacterial contamination. Additionally, the method for platelet procurement must result in less than 2 mL’s of donor red cells in the platelet product.

K. The contractor will provide toll free telephone numbers for contacting the local facility and/or satellite facilities, reference laboratory and the distribution/hospital services for dayshift and after-hours coverage. The contractor shall be responsible for ensuring these numbers are keep current and up to date at all times.

L. The contractor will guarantee to provide blood and services within the following timeframes following the receipt of a fax, electronic, or telephone request:

Product and/or Service Timeframe

Single Donor Platelet Units (Stat) 1 hour STAT orders 1 hour Irradiated units* 8 hours Antigen Negative Units* 8 hours Fresh Frozen Plasma 8 hours Stat Serological Problem Cases 12 hours All Other Serological Problem Cases** 24 hours

*With the exception of rare units. Communication from vendor is required indicating expected time frame of arrival due to rare source of antigen unit.

**Preliminary case resolution shall be communicated within 12 hours. Final resolution of each serological case is dependent on the case complexity.

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M. The contractor will supply the VA with assurance of the following:

a. Traceability of all products from collection to delivery

b. Quality Control (QC) procedures and the contractor shall make QC data available for review.

c. Quality management systems are in place.

d. Current Good Manufacturing Practices are followed.

N. The units of Red Blood Cells delivered to Martinsburg VAMC will have a preferred dating period of four (4) weeks or more from the date of delivery. The delivery of short dated units (units with less than 12 days left before expiration) shall require a written and/or verbal communication to an authorized individual at the facility.

O. The contractor will be responsible for transporting and storing blood components (frozen, room temperature, and refrigerated) and specimens is such a manner as to insure the integrity of the specimen and comply with accreditation standards and requirements as defined by the FDA and American Association of Blood Banks (AABB).

P. The contractor will provide evidence of their verification of the Temperature Monitoring process used for the storage and transportation of products. The contractor shall state the frequency of the temperature validation for the transportation of products, type of coolant material used (i.e. wet ice), and how many pounds of coolant material is required per unit of product.

Q. The facility will promptly inspect the blood product upon receipt and report any actual or suspected damage, irregularity, testing or labeling error. The facility will also promptly report blood lost due to shipping error. The facility will keep complete and accurate records, as required by the law, of patients supplied with blood (product names, lot identifications and quantities), any therapeutic adverse effects and complaints and other blood-related information.

R. Upon discovery, the facility will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from blood (“Adverse Event”). The facility will cooperate with the Contractor’s investigation of any Adverse Event and supply information concerning the recipient of the blood to the Contractor, on forms provided by the Contractor.

S. Contractor will issue credit for all products Transferred/Returned per the following return policy/procedures:

(1) A return credit of 100% of the rate charged/billed per item will be allowed for any product transferred/returned.

(2) Any product that arrives at the facility in a broken container (not intact) shall be returned for 100% credit. This is to include any frozen product where the broken and/or cracked unit is not discovered until it is thawed.

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 6 of 10 Original Date: 10/12/17 Revision 04 Date: 06/10/20

(3) Any red blood cells and whole blood (except any patient-selected donations and any autologous blood) may be returned for credit if outdated or not needed. Full credit if received with a full 7 days of expiration for red blood cells.

(4) Any product that arrives outside of acceptable regulated/accredited temperature ranges shall be returned for credit.

(5) Single donor platelets having twenty-four (24) hours or more remaining before being outdated may be returned for full credit.

(6) Autologous unit credit shall be given in the situation where a patient is a no-show or the surgery is cancelled and not rescheduled before expiration of the blood.

T. The contractor will have the following licenses and or registrations and shall make them available for review by the VA with the proposal:

(1) The Contractor will maintain an unrevoked U.S. License which is issued by the

Director, Bureau of Biologics, FDA under Section 351 of the Public Health Service Act, as amended , 42 USC Section 262, as a source of supply for whole blood.

(2) If the Contractor is involved in interstate shipment of blood or blood component is involved, the Contractor must maintain approval authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262.

(3) The Contractor’s blood bank must maintain registration and/or licensing with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260 at all times during the contract period.

(4) Certificate of Accreditation under the Clinical Laboratory Improvement Act of 1988 or current certification by the College of American Pathologists.

U. The Contractor will deliver the components under storage conditions as required by FDA and AABB regulations and standards.

V. Blood components will be labeled as to the A, B, O and Rh type.

III. CONTRACTOR REQUIREMENTS

A. The contractor(s) will provide all necessary labor, materials, supervision, and transportation vehicles required to perform and/or provide the services herein. If the contractor utilizes other transportation sources, the contractor will bear all costs associated for transportation.

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B. The contractor must currently be registered and/or licensed with the Food and Drug Administration (FDA), Department of health and Human services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260.

C. The Contractor must submit proof that he holds an unrevoked U.S. License which is issued by the Director 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.

D. Contractor will submit with the offer a statement of approval regarding interstate shipment of human blood components. The shipment of human blood components must comply with the following regulations:

1. Section 251 of the Public Health Service Act, as amended, 42 USC Section

262. A. Code of Federal Regulations (21) Section 606.120 and 606.121 Subpart G

2. Code of Federal Regulations (21) Section 606.165 Subpart I

3. Code of Federal Regulations (2 l) Section 210 and 211

4. The American Association of Blood Banks 17th Standards for Blood Bank and Transfusion services: Standard Number G l .000 and 02.000.

E. The contractor will be responsible for ensuring that all transport personnel are trained and follow the storage requirements for blood products and that their competency is regularly assessed in “Universal Precautions” for the handling and transportation of blood borne pathogens. This should include issues such as adherence to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc. The contractor shall submit evidence of their training and annual competency programs within 10 days after award and each renewal year. During the term of this contract, this program may need to be updated and/or revised to comply with regulatory requirements. This documentation should be made available to the Martinsburg VAMC upon request.

F. When contractor personnel enter upon government grounds, they shall adhere to the following policies:

A. All contractor personnel must have ID badges from the contractor worn at all times and displayed above the waist when entering Martinsburg VA Medical Center.

B. It is the responsibility of contractor personnel to park only in designated parking areas. Parking information is available from the VA Police Service.

The VA will not invalidate or make reimbursement for parking violations of the contractor’s personnel under any circumstances.

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C. Smoking is not permitted within or around the VA Healthcare System facilities, except in designated areas.

G. Contractor will provide human blood components only from “volunteer donors” in accordance with the latest FDA regulations. A “volunteer donor” is a person who does not receive monetary payment for blood donations. Donor selections shall be in accordance with criteria established by the FDA and/or AABB.

H. Contractor will protect and Veterans’ personal and medical information provided by the VAMC to the contractor to provide blood products or IRL services. Certification and Accreditation requirements do not apply, and a Security Accreditation Package is not required.

I. The contractor and their personnel will be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST’s Web site at:

http://checklists.nist.gov

J. To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in “VA Information and Information System Security/Privacy Requirements for IT Contracts” located at the following Web site :

http://www.iprm.oit.va.gov

K. The contractor will conduct marketing practices in compliance with applicable laws.

L. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the Contracting Officer.

IV. INSPECTION AND ACCEPTANCE

A. The VA reserves the right to inspect the contractor’s facilities at any time. The Contracting Officer Representative (COR) shall make inspection of blood products. The COTR has the authority to inspect quality, quantity and verify adherence by the contractor to the technical and delivery requirements of the contract.

B. The COR will be identified upon contract award. The Contracting Officer’s

Representative (COR) and/or his/her delegate are the VA personnel authorized to request services and supplies under this contract.

V. DELIVERIES OR PERFORMANCE

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 9 of 10 Original Date: 10/12/17 Revision 04 Date: 06/10/20

A. All deliveries will be FOB destination within the VA’s premises. Contractor agrees to deliver supplies and/or services as requested by the VA on 24-hour, 7-day week availability regardless of Federal Holidays. Deliveries designated as routine shall not carry any additional charges. Additional charges may be applied for after-hour services.

B. Routine orders for inventory replenishment of blood products will be delivered by courier to the VA Medical Center 7 shipments per week. Requests for urgent or emergency delivery will be made by contractor and must be available to receive emergency and/or non-routine orders for blood and blood products 24 hours per day, seven days per week.

C. Transportation costs for Stat and emergency: Contractor will provide pricing for such deliveries. Price submitted will locked for the period of that year award.

D. The contractor will be responsible for rotating the product. There will be no charge to the facility for product wastage.

E. Deliveries shall be made to Veterans Affairs Medical Center Blood Bank, Building 500, 510 Butler Avenue, Martinsburg, WV 25405.

F. Items requiring lab services shall be picked up by the courier delivering blood to the VA

Medical Center unless otherwise arranged with contractor.

VI. PAYMENT

A. The contractor will supply accurate and timely invoices for billing reconciliation within 2-3 business days. The contractor shall state if the products are discounted up front and/or if there is a discount for quick pay.

B. Payment will be made monthly in arrears upon receipt and certification of a proper invoice at the designated invoice office. A proper invoice shall list the total quantities of each product or service provided during a particular month, including date and quantity.

C. Original invoices from the contractor shall be mailed to the following payment address:

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin, TX 78714 – 9971

VII. REPORTS

A. By the 10th of each month, the Contractor shall provide the contracting officer representative (COR) totals of items and services used, during the preceding calendar month, using the item numbers and descriptions exactly as they are listed in the contract.

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 10 of 10 Original Date: 10/12/17 Revision 04 Date: 06/10/20

B. Within 30 days and after the end of the contract period, the contractor shall provide the contracting officer representative (COR) totals of products and services purchased in the same format as the monthly report.

C. The annual report shall also show total costs for each item and total cost for the year.

The contract period of performance is from award date through 09/30/2021 with four option years.

Place of Performance/Place of Delivery Veterans Affairs Medical Center Blood Bank Building 500 510 Butler Avenue Martinsburg, WV 25405

All provisions and solicitations are provided in the attached solicitation.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received not later than noon EST on 10/26/2020. Please submit quotes through beta.SAM.gov or to the Point of Contact below.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212- 1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact

Christopher Hartley- Christopher.Hartley1@va.gov mailto:Christopher.Hartley1@va.gov