SOURCES SOUGHT
65 -- BPA Blood Bank Products (MPLS & SC)
- Notice Date
- 4/29/2019
- Notice Type
- Synopsis
- NAICS
- 621991
— Blood and Organ Banks
- Contracting Office
- Department of Veterans Affairs;NETWORK 23 CONTRACTING OFFICE;Contract Officer;4801 Veterans Drive;St. Cloud MN 56303
- ZIP Code
- 56303
- Solicitation Number
- 36C26319Q0547
- Response Due
- 5/6/2019
- Archive Date
- 5/21/2019
- Point of Contact
- Wendy Hoeschen
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The responses received from interested contractors will assist the Government in determining the appropriate acquisition method. The Department of Veterans Affairs (VA), NCO 23- St Cloud is requesting procurement information for Blood and Blood Products for the Minneapolis and St Cloud VA Health Care Systems both located in Minnesota. Blood Product Supply and Transfusion Related Referral Testing General Requirements: Contractor will provide the Minneapolis VA Healthcare System, 1 Veterans Drive, Minneapolis, Minnesota, 55417, herein after referred to as MVAHCS, and the St. Cloud VA Healthcare System, 4801 Veterans Dr, St. Cloud, MN 56303, herein after referred to as SCVAHCS, with blood products and transfusion related referral lab testing as specified in the schedule of items. The MVAHCS and SCVAHCS are requesting a base year of twelve (12) months, with four (4)- twelve (12) month option years to be exercised at the discretion of MVAHCS. 1.A. Schedule of items: Products and services required by MVAHCS and SCVAHCS from contractor. The quantities as listed in this Schedule of Items are estimated yearly requirements. The MVAHCS and SCVAHCS attempt to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities as listed below. All products and services will be requested on an on demand, as needed basis. Item # Product Description ISBT Codes Qty for MVAHCS Qty for SCVAHCS Total Qty 1 Red Blood Cells, Leukocyte Reduced E0686V00, E0685V00, E0336V00, E0181V00, E0678V00, E0661V00 2000 200 2200 2 Red Blood Cells, Leukocyte Reduced Irradiated E0332V00, E0668V00, E0669V00 400 60 460 3 Red Blood Cells, Saline Washed E5170V00 5 0 5 5 Platelets, Apheresis, Leukocyte reduced E3088V00, E3077V00, E7011V00, E3089V00, E3087V00 80 25 105 6 Platelets, Apheresis, Leukocyte reduced, Irradiated E3058V00, E3057V00, E3056V00, E3046V00 10 5 15 7 Platelets, PAS E7003V00, E7001V00, E7004V00, E7002V00 750 0 750 8 Platelets, PAS, Irradiated E7008V00, E7007V00, E7006V00, E7005V00 500 0 500 9 Platelets, Psoralen Treated E8341V00, E8342V00, E8343V00, E8340V00 52 0 52 10 Fresh Frozen Plasma (Frozen within 24 hours) 86927 10 8 18 11 Frozen Plasma (Frozen within 24 hours) E2555V00, E7644V00 500 8 508 12 Plasma, Cryoprecipitate Reduced P9044 100 0 100 13 Cryoprecipitate AHF Pooled E7588V00 100 0 100 14 HLA Typed Product Surcharge 5 0 5 15 Granulocyte, Apheresis E7588V00 5 0 5 Brief Description of Service* CPT Code Qty for MVAHCS Qty for SCVAHCS Total qty 16 Platelet Crossmatch 86022 50 2 52 17 RBC Antigen Typing (per antigen) 86905 150 10 160 18 ABO type 86900 5 0 5 19 RH Type 86901 5 0 5 20 Antibody Screen 86850 5 0 5 21 Compatibility prescreen 10 10 20 22 Antibody Identification 86870 20 5 25 23 Antibody Elution 86860 5 0 5 24 DAT, each antiserum 86880 20 0 20 25 RH phenotype complete 86906 5 0 5 26 Differential Adsorption of serum 86978 5 0 5 27 Babesia testing of RBC's 86317 2400 250 2650 28 HEA Panel Testing 81403 2 2 Specifications of Contractor: All blood products offered must be provided from a blood bank that is currently 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 U.S.C. Section 260. The contractor must make paper copies available to both MVAHCS and SCVAHCS of the Circular of Information for the Use of Human Blood and Blood Components, which, by FDA regulation, must be available to all prescribing physicians. The Contractor must submit proof that it holds 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 U.S.C. Section 262, as a source of supply for biological products. Contractor must provide products from blood banks that are able to provide both MVAHCS and SCVAHCS with 100% volunteer donor blood in accordance with FDA rules and regulations. 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. The contractor and its health-care providers will be liable for their liability-producing acts or omissions. The contractor will maintain or require all health-care providers performing under this contract to maintain, during the term of this contract, professional liability insurance issued by a responsible insurance carrier of not less than the following amounts, per specialty, per occurrence: One million dollars, unless the contractor is an entity or subdivision of a State that either provides for self-insurance or limits the liability of the amount of insurance purchased by State entities, then the insurance requirement of this contract will be fulfilled by incorporating the provisions the applicable State law. The Contractor, upon request of the contracting officer, prior to contract award, will furnish evidence of the insurability of the Contractor and/or of all health-care providers who will perform under this contract. The submission will provide evidence of insurability concerning the medical liability insurance required as described above or the provisions of State law as to self-insurance, or limitations on liability or insurance. The Contractor must provide Certificates of Insurance or insurance policies evidencing the required insurance coverage and an endorsement stating that any cancellation or material change adversely affecting the Government s interest will not be effective until 30 days after the insurer or the contractor gives written notice to the contracting officer. Certificates or polices will be provided for the contractor and/or each health-care provider who will perform under this contract. The contractor must notify the contracting officer, or any of the health-care providers performing under this contract, of any change in insurance providers during the performance period of this contract. The notification will provide evidence that the contractor and/or health-care providers will meet all the requirements of this clause, including those concerning liability insurance and endorsements. These requirements may be met either under the new policy, or a combination of old and new polices, if applicable. The contractor must obtain all necessary licenses and/or permits required to performed work described in this contract. Contractor will take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. The contractor will be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employee s fault or negligence, and will maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Minnesota. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, will not be the responsibility of the contractor here under with the regard to any claims, loss, damage, injury, and liability resulting there from. Contractor must present evidence of their technical capability to provide blood products which pass acceptable standards for blood banks per American Association of Blood Banks (AABB) Standards. The reference laboratory must be accredited by American Association of Blood Banks (AABB), Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA), and must supply proof with proposal. Upon request, the contractor must provide evidence of their quality process, proficiency testing, and surveillance by accreditation agencies. Collection Requirements: Minimum collection requirements contractor must follow: All blood products are to be collected by the closed system under aseptic conditions and will be processed in appropriate solutions and the container so labeled. A sample of blood from each donation will be tested for infectious diseases and all testing shall comply with AABB (American Association of Blood Banks) Standards and the Code of Federal Regulations, 21 CFR Parts 606, 607, 610, 630, 640, 660, governing blood products. Products must be non-reactive for infectious disease marker prior to shipment, except with the express written authorization of the VA Blood Bank Medical Director or his/her designee. The contractor will utilize methods to limit introduction of bacteria during collection and processing of blood products, in accordance with the 31st edition AABB Standard 5.1.5.1. Each platelet component must be tested for bacterial contamination using an Food and Drug Administration (FDA) -approved commercial detection system, or use pathogen reduction technology, in accordance with the 31st edition AABB Standard 5.1.5.2 and CAP TRM.44955. The contractor will immediately notify MVAHCS and/or SCVAHCS if subsequent testing indicates the supplied platelets may be contaminated with bacteria. Donor Requirements The contractor will ensure that all donor and blood component records are identified and traceable. Donor selection must be in accordance with criteria established by the Food and Drug Administration (FDA) and/or AABB (American Association of Blood Banks). The contractor will maintain available blood donor lists, including names, addresses, and social security numbers. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to MVAHCS and SCVAHCS under this contract. Under no circumstances will the contractor ever reveal the identity of the blood donor. Contractor s donor identification numbers must be unique to the donor unit and must have a FDA-approved numbering schematic. Each voluntary donation must be minimally tested for the following infectious diseases: Hepatitis B Surface antigen (HBsAG) Antibodies to hepatitis B core (anti-HBc) Antibodies to hepatitis C (anti-HCV) Antibodies to human immunodeficiency virus, type 1 and type 2 (anti-HIV1 and anti-HIV2) Antibodies to human T lymphotropic virus type 1 and type 2 (anti-HTLV-1 and anti-HTLV-II) Genetic viral material to detect HIV type 1 and HCV by nucleic acid amplification Syphilis Zika Babesia Minimum Labeling Blood Product Requirements: All blood products will be typed and labeled for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the AABB (American Association of Blood Bank) Technical Manual. All labels on blood products must be compatible with both MVAHCS and SCVAHCS VBECS systems. The label will also indicate the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn. ISBT-128 labeling must be used on all blood products offered to both MVAHCS and SCVAHCS. Ordering methods and procedures: Contractors Primary preferred method of ordering. Both MVAHCS and SCVAHCS will try their best to accommodate the contractors preferred method of ordering blood products, but do not guarantee they will be able to utilize any forms of ordering other than telephonically placed orders. If preferred method is a web-based portal or computer-based ordering system of any type, implementation is dependent on being found acceptable for use by the ISO (Informational Security Officers) in the VA Healthcare System. If deemed unacceptable for use, there will be no extra charges that incur to the Government for an alternative process of ordering. Routine orders: MVAHCS will place an order for blood products Monday through Friday with the specific products and quantities to be delivered with the daily shipment. The vendor will work with the MVAHCS Blood Bank Supervisor to schedule a standing order for PAS platelets to insure proper coverage for morning surgeries and procedures. Psoralen platelets may be used for the standing order if PAS platelets are not available, but at no additional charge to MVAHCS. SCVAHCS will place an order weekly with the specific products and quantities to be delivered with the weekly shipment. STAT/emergency/additional orders: Requests will be placed by the preferred method, or the backup method, on an on-demand, as-needed basis, by laboratory personnel twenty-four hours a day, seven days per week. Names of lab personnel authorized to place, accept, or reject orders will be provided to the contractor upon request. Packaging, Shipping, and Delivery Time Requirements: Packaging for delivery: All blood products delivered under this contract will be properly packaged and insulated in such a way as to ensure that a proper temperature appropriate for the product is maintained during transport between the contractor s place of business and both MVAHCS and SCVAHCS. Red blood cells: Proper in-transit temp is +1C to +10C, packaged with wet ice. Platelet Products: Proper in-transit temp is +20C to +24C. Frozen Products: Must maintain frozen state. Blood products must be collected, stored, prepared, tested, and shipped in accordance with Food and Drug Administration (FDA) regulations, according to American Association of Blood Banks (AABB) Standards, and U. S. Department of Transportation (DOT) requirements. Minneapolis shipping schedule: Contractor will make a minimum of two scheduled daily deliveries, Monday through Friday, holidays excepted, between the hours of 0700 and 1500 SCT. Delivery times will be determined by the MVAHCS. MVHACS will place the order, via the preferred method of ordering, to the contractor stating the products and quantities needed for their delivery. Occasionally more than two deliveries per day may be required. The contractor must be able to offer extra shipments for deliveries that cannot wait until the next scheduled delivery. The items will be delivered to the following address: Minneapolis Laboratory Blood Bank, Room BB-145, One Veterans Drive, Minneapolis, Minnesota, 55417. St. Cloud shipping schedule: Contractor will make a minimum of one scheduled weekly delivery, Monday through Friday, holidays excepted, between the hours of 0730 and 1500 SCT. Delivery times will be determined by SCVAHCS. SCVAHCS will place the order, via the preferred method of ordering, to the contractor stating the products and quantities needed for their delivery. Delivery will be within 3 hours of SCVAHCS notifying the contractor of the need. Occasionally more than one delivery per week may be required. The contractor must be able to offer extra shipments for deliveries that cannot wait until the next scheduled delivery. The items will be delivered to the following address: St. Cloud Laboratory Building 1 Basement, 4801 Veterans Drive, St. Cloud, MN 56303. The holidays observed by the Federal Government are as follows: New Years Day* Martin Luther King Day (3rd Monday in January) Presidents Day (3rd Monday in February) Memorial Day (last Monday in May) Independence Day* Labor Day (first Monday in September) Columbus Day (2nd Monday in October) Veterans Day Thanksgiving Day* Christmas Day* Any day which is declared a federal holiday by the President *Note: If the federal holiday falls on a Saturday, it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday. Delivery time requirements: STAT/emergency orders: Blood must be available twenty-four hours per day, seven days per week. Contractor must be able to make deliveries for emergency blood requirements within 60 minutes of notification of need to MVAHCS and SCVAHCS. ASAP: Delivery will be within two hours of notification of need to MVAHCS and SCVAHCS. Routine: Deliveries will be made per delivery schedule mutually agreed upon with contractor and both MVAHCS and SCVAHCS. Each site will be fairly flexible with scheduled routine deliveries to accommodate for delivery schedules with other site s transfusion needs. Once units are received at both MVAHCS and SCVAHCS, those units become their property, and payment will be made appropriately, based on contract terms and proper invoicing. They are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by both MVAHCS and SCVAHCS to assist the contractor and other facilities in meeting patient transfusion needs. Acceptance and Rejection Criteria for Blood Products: All blood components will be labeled, stored, and shipped in accordance with the current regulations of the Food and Drug Association (FDA), American Association of Blood Banks (AABB) and U.S. Department of Transportation (DOT). In the event these regulations change during the course of the contract, the contractor will implement the necessary changes as directed/recommended by the regulatory and accrediting agencies. The contractor must notify both sites of any changes. All blood products supplied will be grossly free of hemolysis, excessive chyle, and clots. Additional criteria for red blood cells: The individual units must be visually inspected for any abnormality in color or physical appearance and for any indication of microbial contamination. If evidence exists, the units will not be accepted into inventory. Units must have at least four segments remaining. Additional criteria for platelet products: The individual units must be visually inspected for any abnormality in color or physical appearance and for any indication of microbial contamination. If evidence exists the units will not be accepted into inventory. Contractor will be in compliance with CAP TRM.40760, and Standard 5.15.5. in the 31st edition of AABB (American Association of Blood Banks) Standards, which states Platelets shall be ABO compatible with the recipient s plasma and be crossmatched as in Standard 5.16 unless the component is prepared by a method known to result in a component containing < 2mL of Red Cells. Therefore, if the platelets appear to be pink in color they will not be accepted into inventory. Shelf life of blood products that will be found acceptable: For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below: Whole Blood: Shelf life more than 21 calendar days, regardless of anti-coagulant Red Blood Cells: Shelf life more than 21 calendar days, regardless of anti-coagulant Fresh Frozen Plasma: Shelf Life more than 60 calendar days Platelets (random): Shelf life more than 48 hours Cryoprecipitate: Shelf life more than 60 days Rotation of stock: Contractor will make an effort to work with both MVAHCS and SCVAHCS to schedule a return of blood products to replace with better out dates to avoid components from expiring on the shelf. Credit for Returned or Rejected Blood Products: Credit will be given when blood is delivered to either MVAHCS or SCVAHCS with a shelf life of 10 days or fewer. The contractor may contact either MVAHCS or SCVAHCS if the only product available has a short shelf life, and it is the only blood available to meet the patient s needs. The VA can determine whether to accept or reject the blood available to meet the patient s needs. The contractor will provide credit for products that are put into quarantine at their direction, which either expire while in quarantine, or if MVAHCS or SCVAHCS is unable to use due to the extended time the products were out of circulation. When blood products do not meet the acceptance criteria of MVAHCS or SCVAHCS. Acceptance criteria may be based on abnormalities in physical appearance, indications of contamination, product temperature on receipt, and other criteria regarding the quality or acceptability of blood products. Full credit will be given for outdated platelets that are expired on-site and unable to return. Full credit will be given for frozen plasma that ruptures during thaw. Contractor must be able to rotate stock with both MVAHCS and SCVAHCS. If contractor is unable to rotate stock to avoid blood products from expiring, a credit will be issued. Recalled and Defective Products: The contractor will immediately notify the affected MVAHCS or SCVAHCS when information is discovered indicating that a blood product may not be considered safe. As appropriate, the contractor will replace and/or reimburse recalled/defective products at no cost to the government. With respect to blood manufactured by the contractor, contractor will provide the following notifications to MVAHCS and/or SCVAHCS. Within 3 calendar days if blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection. Within forty-five (45) calendar days of the test, the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA As set forth in 21 C.F.R 610.46-610.48. TRALI Risk Reduction Strategies: Transfusion-related acute lung injury (TRALI) is a major cause of transfusion-related morbidity and mortality. The contractor will implement all published AABB recommendations and Standards regarding donor management strategies to reduce the risk of TRALI, and must inform MVAHCS and SCVAHCS in writing of any changes to their TRALI risk reduction plan. An updated risk reduction plan will be sent to each site annually. Reporting of Adverse Transfusion Events: MVAHCS and SCVAHCS will keep complete and accurate records, as required by law, of patients transfused with any blood products. Both MVAHCS and SCVAHCS will report any possible transfusion-transmitted infections or other serious complications associated with transfusion to the contractor. Both MVAHCS and SCVAHCS will co-operate with the contractors investigation of any adverse event and supply information concerning the recipient of the blood product to the contractor on forms provided by the contractor. Patient information will only be shared if deemed necessary by the American Association of Blood Banks (AABB), Food and Drug Administration (FDA), or Department of Health regulations. In this event, either the MVACHS or SCVAHCS privacy officers may need to provide written approval. Immunohematology Reference Laboratory Services: Availability and turn around times: Immunohematology Reference Laboratory (IRL) Services for red cell antibody identification must be available twenty-four hours per day, seven days per week, and must provide test results and antigen negative blood products within twenty-four hours for urgent clinical situations, and within forty-eight hours in non-urgent situations. The reference laboratory must keep MVAHCS and SCVAHCS informed if the required testing is going to exceed the listed timeframe. Tests that will be performed are specified in the Schedule of items 1.A. section of this contract. RESPONSES MUST INCLUDE THE FOLLOWING INFORMATION: Company Name, Address, Size Standard, DUNS #, Cage Code Point of Contact name, phone number, and email address NAICS Code 621991 and Small Business Size Standard $32.5 Million. MUST be assigned to company Capability Statement *NOTE Acquisitions will only be set aside for SDVOSBs/VOSBs if two or more responses are received with the required information listed above, by the due date specified below. Only SDVOSB and VOSB offerors are invited to respond to this Sources Sought Notice via email to wendy.hoeschen@va.gov, along with any other questions or concerns, no later than 05/6/2019. GREY MARKET ITEMS: The Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM. The vendor shall provide new items ONLY; no remanufactured or grey market items. All items must be covered by the manufacturer s warranty. The offeror shall provide evidence of its authority to distribute the proposed equipment/system at the time of submission of its quote/offer. Please note that such evidence is subject to verification by the Contracting Officer at his/her discretion. Disclaimer and Important Notes: This Sources Sought Notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. The Government will treat any information received as proprietary and will not share such information with other companies. Any organization responding to this Sources Sought Notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this announcement. There is no solicitation available at this time. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (29-APR-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
-
Link To Document
(https://www.fbo.gov/spg/VA/SCVAMC656/SCVAMC656/36C26319Q0547/listing.html)
- Place of Performance
- Address: One Veterans Drive;Minneapolis MN
- Zip Code: 55417
- Country: USA
- Zip Code: 55417
- Record
- SN05295384-F 20190501/190429230012 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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