SOURCES SOUGHT
66 -- Salisbury BLOOD BANK
- Notice Date
- 8/14/2019
- Notice Type
- Synopsis
- NAICS
- 621991
— Blood and Organ Banks
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
- ZIP Code
- 23667
- Solicitation Number
- 36C24619Q1009
- Response Due
- 8/15/2019
- Archive Date
- 11/22/2019
- Point of Contact
- AMY.BALICAT@VA.GOV
- Small Business Set-Aside
- N/A
- Description
- Page 4 of 4 THIS IS A SOURCES SOUGHT NOTICE ONLY. This notice does NOT constitute a request for proposal, request for quote, or invitation for bid. No formal solicitation document exists at this time. We are seeking information for market research purposes only. The Government will not pay for any information solicited. The VHA Network Contracting Office 6 (NCO 6) is conducting a market survey to find qualified vendors who can provide the following items: BLOOD AND BLOOD COMPONENTS STATEMENT OF WORK W.G (Bill) Hefner VAMC (Salisbury) and Charles George VAMC (Asheville) SCOPE: The VISN 6 Medical Centers need blood and blood components for their patient population. These components/supplies must be provided to each facility per the Statement of Work. STATEMENT OF WORK/SERVICES TO BE PROVIDED: The contractor(s) shall furnish the following Food and Drug Administration (FDA) approved blood, blood components, and services as described herein to the participating VAMC facilities. The contractor will list and provide the contract price, for the base year and the additional option years, for any blood or service that is not included in this contract. A projection of the estimated quantities of products and services required for the next five (5) years is listed by the participating facilities. Quantities listed are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum. 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). This is an AABB standard therefore proof of accreditation/certification/license shall be submitted with offer. 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. 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. The contractor shall ensure that all contract 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). All blood and blood components (frozen, room temperature and refrigerated) 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. 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. The contractor shall provide the requirements, special collection forms and the collection of Autologous and directed donor units at their collection centers for the purposed facilities. The contractor shall 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 shall 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. 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 1-10 degrees Celsius, preferable 1-6 degrees Celsius while in transit. All blood supplied to the VA shall be from volunteer donors in accordance with FDA rules and regulations. Donor selections shall be in accordance with criteria established by the FDA and/or AABB. The contractor shall 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. The contractor shall guarantee to provide blood and services within the following timeframes following the receipt of a fax, electronic, or telephone request: Product and/or Service Asheville Salisbury As soon as possible (ASAP) orders 4 hours 4 hours STAT orders 3 hours 3 hour Irradiated units* 3 hours 3.5 hours Antigen Negative Units* 8 hours 8 hours Washed Units 3 hours 6 hours Platelet Antibody Screens And Cross-Matches (STAT) 24 hours 24 hours STAT Serological Problem Cases 12 hours 8 hours All Other Serological Problem Cases** 24 hours 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 negative unit. **Preliminary case resolution shall be communicated within 12 hours or the stated period, whichever is less. Final resolution of each serological case is dependent on the case complexity. The contractor shall supply any specialized product that has been modified (i.e. washed Platelets which has caused the unit expiration to be dramatically reduced) to the facility with at least 1.5 hours remaining on the product expiration time. Contractor shall comply with the following: Contractor shall 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. Such listings shall indicate on what date blood of a particular donor 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. The units of Red Blood Cells and Platelet Pheresis delivered to the facility will have the longest possible shelf life available to meet an agreed upon par level for each product on a daily basis. The vendor will work with the facility to ensure a rotation of product occurs on a regular and recurring basis to ensure product availability to meet patient needs, as well as keep waste to an absolute minimum (both Asheville and Salisbury must maintain one unit of Platelet Pheresis to be available at all times, a stock rotation system with the contractor must be established which allows the exchange of unused platelet products that would otherwise expire). ). The contractor will use reasonable efforts to supply the Government with the blood as set forth in this contract, contingent upon availability of the blood, an adequate amount of voluntary blood donations, and a lack of force maj eure events as set forth in 52.212-4(f). The contractor(s) shall 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. The Contractor will be responsible for transporting and storing blood components (frozen, room temperature and refrigerated) and specimens in such a manner as to insure the integrity of the specimen. The contractor shall 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. Contractor shall 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: 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 Code of Federal Regulations (21) Section 606.165 Subpart I Code of Federal Regulations (2 l) Section 210 and 211 The American Association of Blood Banks 17th Standards for Blood Bank and Transfusion services: Standard Number G l.000 and 02.000. The contractor(s) shall deliver supplies and provide courier services for reference lab specimens as requested by each facility on a twenty-four (24) hours per day, seven (7) days per week, including all holidays. Contractor shall provide up to seven (7) routine scheduled deliveries per week with up to two (2) additional as needed STAT deliveries. per week to each facility receiving service through a contract. All deliveries are to be made directly to the each facility (specific locations at each facility to be designated after award of contract) at no additional charge to the facility. Routine delivery schedules are evaluated and/or altered periodically according to blood/service utilization. The contractor shall be responsible for insuring 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 upon request. 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 requesting facility. VISN 6 facilities upon their request. When contractor personnel enter upon government grounds, they shall adhere to the following policies: All contractor personnel must have ID badges from the contractor worn at all times and displayed above the waist when entering a VISN 6 VA Medical Center. 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. Smoking is not permitted within or around the VA Healthcare System facilities, except in designated areas. The facility will promptly inspect the blood 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. 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, upon forms provided by the Contractor. Contractor shall issue credit for all products Transferred/Returned per the following return policy/procedures: A return credit of 100% of the rate charged/billed per item will be allowed for any product transferred/returned. 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. 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. Any product that arrives outside of acceptable regulated/accredited temperature ranges shall be returned for credit. Single donor platelets having twelve (12) hours or more remaining before being outdated may be returned for credit. 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. The contractor shall provide guidance within twenty-one (21) days of award on the packaging of products for return and/or if the couriers will be responsible for the packaging of products for return. The contractor will analyze the VISN 6 Medical Centers blood and blood components usage and implement measures to reduce wastage of blood products through expiration during the first 30 days of the contract (10/1/19-10/31/1914-10/30/14). Measures may include adjusting stock or accepting products returns prior to expiration dates. The contractor will conduct marketing practices in compliance with applicable laws. The Contracting Officer s Representative (COR) and/or his/her delegate are the VA personnel authorized to request services and supplies under this contract. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the VA Mid-Atlantic Healthcare System (VISN-6) Contracting Officer. Contractor shall be responsible for finding an outside laboratory with appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify the VA Laboratory and Contracting Officer of any change of subcontract. Any changes shall be submitted to the Contracting Officer in writing for review and approval. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the contracting officer. This contract is subject to compliance by the contractor and the Government with: (a) all recommendations from, or requirements mandated by, any state or federal agency, and (b) requirements of applicable accreditation agencies. The Government is responsible for the incremental costs of such recommendations and requirements, so long as the contractor provides the Government with sixty (60) days prior, written notice of such incremental costs. The contractor and their personnel shall 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 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 The contractor shall supply accurate and timely invoices for billing reconciliation within 2-3 business days after the close of the billing period.. The contractor shall state if the products are discounted up front and/or if there is a discount for quick pay. The contractor shall offer the following Transfusion Medicine reference lab services: Non-routine and complex antibody work-ups using multiple methodologies Determination of the presence of rare antigens Crossmatching least incompatible red blood cells HLA typing of patients and blood products (particularly platelets) Platelet crossmatching Irradiating Blood Products Washing Blood Products Communicating in a timely manner both the preliminary and final reference lab testing results to the ordering facility. If the contractor can provide the above-mentioned units, brand name or an equal to product, the contractor SHALL submit product information for evaluation. If the contractor can provide the above items, the contractor SHALL provide a letter from the manufacturer stating they are an authorized distributor/licenser of their products. Failure to submit an authorized distributor letter shall result in the product(s) potentially offered to be considered grey market and shall not be considered technically acceptable. All responses shall be submitted no later than 1400 EST on Thursday August 15, 2019. All interested parties should respond in writing, via email, to Amy.Balicat@va.gov. No telephone inquiries will be accepted. In response, please include the following: Company/individual name, Address, Point of contact with phone number Indicate FSS/GSA contract number or Open Market, as applicable FSS Category you qualify for Tax ID number DUNS number Capabilities statement Company Socio-Economic SIZE (example large, small, SDVOSB, VOSB, WOSB etc.) Sufficient information to demonstrate the ability to provide the required item If your firm is a Service-Disabled Veteran-Owned or Veteran-Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). The Veteran Administration is required to give priority to SDVOSB and then VOSB concerns if there should be sufficient firms available to compete under a set-aside. If insufficient veteran owned small business responses are received, the acquisition will be set-aside for small business participation if there are sufficient firms available. If insufficient small business responses are received, the action will be advertised for full and open competition. Please title the subject line for all responses as: Sources Sought Blood bank: 36C24619Q1009 Locations where deliveries are needed: Salisbury VAMC 1601 Brenner Ave Salisbury, NC 28144 Asheville VAMC 1100 Tunnel Rd Asheville, NC 28805 NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (14-AUG-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
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Link To Document
(https://www.fbo.gov/spg/VA/HaVAMC/VAMCCO80220/36C24619Q1009/listing.html)
- Record
- SN05404552-F 20190816/190814230024 (fbodaily.com)
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