65--Blood & Blood Products

This is a Sources Sought (SS) Notice only, not a solicitation announcement and should not be considered as such. There is no solicitation available at this time. The Government will not pay for any information received in response to this SS, nor will the Government compensate any respondent for any cost incurred in developing the information provided to the Government. This SS does not constitute a commitment by the Government. Any information provided in response to this market survey will be used for informational purposes only and will not be released. Vendor participation is not a promise of future business with the Government. The purpose of this SS is to conduct Market Research to gain knowledge of potential qualified sources and their size classification (hub zone, 8(a), small, small disadvantage, service disabled veteran owned small business or large business) relative to NAICS Code 621991. The Department of Veterans Affairs, Network Contracting Office 10, is conducting market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Hub zone Small Businesses, Woman Owned Small Businesses or 8(a) firms capable of performing the requirements to warrant a set-aside. Carefully consider the description of supplies and services, and the Statement of Work (SOW) prior to submitting your interest in this contract. Description of Supplies and Services Provide by the Contractor The proposed contract will support LSCVAMC, Pathology and Laboratory Services, Blood Bank Services. Specific blood products and estimated quantities are as follows: Description Minimum Est Yearly Qty Red Blood Cells Leukoreduced 4,000 Pooled LR Plat 5 Day 50 Platelets Pheresis 900 Cryoprecipitated AHF (5 Pack Pooled) 100 Frozen Plasma 700 Autologous Red Blood Cells Surcharge - As Required Directed Donor Red Blood Cells Surcharge As Required RBC 'O' Premium Surcharge 2,000 AB' FFP Surcharge 120 Historic Antigen Negative Red Blood Cells - As Required Confirmed Antigen Negative Red Blood Cells - As Required Reference Laboratory Fees As Required Credit for Returned Blood As Required Statement of Work (SOW) 1. SCOPE OF SUPPLIES/SERVICES PROVIDED The supplier shall furnish the Blood Products in FDA approved plastic blood bags appropriate for each blood product for the Louis Stokes Cleveland Veterans Administration Medical Center (LSCVAMC), Pathology and Laboratory Medicine Services (PLMS) located at 10701 East Boulevard, Cleveland, OH 44106. Products shall be supplied in such quantities and at such times as may be required in accordance with all terms, conditions, provisions and the schedule herein. A. Blood Product Suitability (1) Blood shall be tested by the Contractor for ABO and Rh types, and screened for unexpected antibodies, in accordance with methods recommended by FDA. Only blood testing negative for infectious disease testing per FDA guidelines shall be used for transfusion. (2) All blood shall be collected by the Contractor in a closed system under aseptic conditions and processed in appropriate solutions and labeled containers. Blood shall be collected in an FDA approved container that is pyrogen free and sterile and which contains sufficient anticoagulant for the quantity of blood to be collected. All blood shall be free of gross chyle, hemolysis, icterus, and clots. The container label shall state the type and amount of anticoagulant and shall otherwise be in compliance with FDA guidelines. (3) VA will not accept Low-volume Red Cells. (4) All Packed Cell containers shall have at least one (1) peel-off ISBT whole blood number on the back of the container and at least two (2) heat sealed segments on each container. (5) All Packed Cell units shall have at least seven (7) days of shelf life prior to expiration. Units with less than seven (7) days of shelf life (short dated units) shall be cleared with a VA Blood Bank technologist prior to sending. (6) All Pheresis Platelet units shall have at least one (1) day of shelf life prior to expiration. Units expiring on the same day received (short dated units) shall be cleared with a VA Blood Bank technologist prior to sending. B. Donor Requirements (1) The contractor shall certify compliance with the requirements outlined below with respect to donors, containers, delivery, etc. (2) The contractor shall provide the Louis Stokes Cleveland Veterans Affairs Medical Center with volunteer donor blood in accordance with current FDA rules and regulations. A volunteer donor is defined as a person who does not receive monetary payment for blood donation. Benefits such a monetary time off from work, membership in blood assurance program and cancellation on non-replenishment fees that are not readily convertible to cash do not constitute monetary payment. (3) The contractor shall, according to the most recently published Federal, State and local regulations, and according to the contractor s policy, prepare and follow policies and procedures to take appropriate action on whole blood and blood components which are at increased risk for transmitting HIV and other required infectious disease markers to include, but are limited to look-back , quarantine and product recall and whether an on what date blood from a particular donor was furnished to the Department of Veteran s Affairs under this contract. (4) Donor selection shall be in accordance with criteria established by the FDA. C. Return/Credits ( 1) The LSCVAMC may receive full or partial credit for Blood provided to the LSCVAMC by the Vendor under the limited circumstances set forth below. Damaged Blood: If the Blood arrives to the Customer: (1) in a damaged condition, or (2) in a condition rendering the Blood unsuitable for transfusion, then the Customer should discard the Blood, unless the Vendor instructs otherwise, and the Customer may request credit when appropriate. If the Vendor requests the return of Blood, the Vendor will pay the shipping costs associated with such returns. Regulatory Recall: If the FDA or another regulatory agency requires the Vendor to recall Blood, or if the Vendor voluntarily chooses to recall Blood for quality reasons, the Customer will discard the Blood unless the Vendor instructs otherwise. If the Vendor requests the return of recalled Blood, the Vendor will pay the shipping charges associated with such returns. Reporting and Documentation of Returns: In the event the Vendor requests the return of Blood, the Customer will ensure that all shipments of returned Blood are accompanied by a completed Credit Request for Products Form provided by the Vendor ("Credit Request for Products Form ). The individual completing the Credit Form certifies that: (1) the returned Blood has not been out of control of the Customer's Blood Bank and (2) the Blood has been continuously stored at the appropriate temperature in accordance with the Code of Federal Regulations. Failure to receive authorization for each unit of returned Blood may result in refusal to credit the Customer for the return of such Blood. Amount of Credit for Discards or Returns. Under no circumstances will the Vendor refund the Customer an amount exceeding the original Fee paid by the Customer to the Vendor. Credit for Shipping Discrepancies. If LSCVAMC receives extra unit(s) of blood in a shipment from the Vendor, LSCVAMC may retain the additional unit(s) at no charge. Note: Creditable discrepancies are defined as a discrepancy between the packing slip and the actual number of units in the shipment. (2) Prior to the return of any product, LSCVAMC must notify the Vendor that the LSCVAMC wishes to physically return a product. At this time the Vendor will instruct the LSCVAMC on the proper procedure and fax the appropriate paperwork required. (3) If the LSCVAMC is instructed to return product, the Vendor will arrange the return with a delivery service. (4) Full credit will be issued to LSVAMC for AB positive and negative Red Cells. D. Registration, Licensure, and Authorization (1) The Contractor shall be registered and licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510(b), (j) and 704 of the Federal Food Drug and Cosmetic Act, as amended, 21 USC Section 360(b), (j) and 374. (2) The contractor shall submit proof of current and unrevoked U.S. license issued by the Director , Bureau of Biologics FDA under Section 351 of the Public Health Service Act as amended by 42 USC Section 262 as a source of supply for whole blood. (3) If interstate shipment of blood or blood components are involved, the Contractor shall submit a statement that approval has been authorized under Section 251 of the Public Service Health Act, as amended 42 USC 262. E. Regulatory Compliance on the Handling and Release of Blood Products (1) In the event of an emergency request for release, the Contractor s blood and blood products released prior to completion of testing will be handled according to Federal and State regulations. (2) With respect to blood manufactured by the Contractor and provided to the government under this contract, the Contractor will provide the following notifications to LSCVAMC: (a) Within three (3) calendar days of discovery if blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV, HCV, or other infectious diseases on a later donation or who is determined to be at increased risk for transmitting HIV, HCV, or other infectious diseases; (b) Within forty-five (45) days of the test of the results of the supplementation (additional , more specific) test for HIV, HCV, or other infectious diseases as relevant, or other follow-up testing required by FDA; and (c) As set forth in 21 CFR 610.48(b)(3) (3) Under no circumstance will the Contractor ever reveal the identity of blood donors. 2. PACKAGING AND MARKING A. Blood shall be furnished and labeled per FDA guidelines. B. Immediately after collection, the blood shall be processed per FDA guidelines. All blood shall be shipped in accordance with FDA regulations. 3. DELIVERY OR PERFORMANCE A. The Contractor shall furnish blood and blood products on an on-call basis as specified in the Schedule. LSCVAMC will visually check blood products upon receipt, take ownership, and become responsible for the blood and blood products upon receipt and acceptance by PLMS. In the event that the Contractor anticipates that a shortage of blood and blood products is pending and/or that aberrations in services, such as local/nationwide disaster, interruption in local services due to strike, fire, flood, electrical failure, etc., may be experienced, the Contractor shall promptly notify the LSCVAMC of such events wherein deliveries can be made as soon as possible. All deliveries will be made to: Louis Stokes Cleveland VA Medical Center Pathology and Laboratory Medicine Services 10701 East Boulevard Cleveland, OH 44106 B. Delivery Instructions. The type of delivery order will be specified when the order is placed and the Contractor shall deliver within the timelines stated below. Time begins when the delivery order is received by the contractor as noted by receipt of confirmation. Routine --------------------------Within 24 (twenty-four) hours, preferably on the day shift. Routine stock delivery orders will be placed by fax/phone during normal business hours, 8:00 a.m. 4:30 p.m. Monday through Friday. LSCVAMC reserves the right to establish pre-arranged routine deliveries with coordination with the Contractor. Emergency (STAT) -----------Within 2 (two) hours Emergency orders may be placed 24 hours a day, 7 days a week, 365 days a year. The Contractor shall have written arrangements in place to supply blood for emergency use and shall provide LSCVAMC with a point of contact with decision making authority. Emergency Blood Products Needed in Less than 2 (Two) Hours. (1) LSCVAMC will call the Contractor when blood is needed in less than 2 hours and the Contractor will respond within 10 minutes with their ability to fill or not fill the order in that time frame. (2) In the event the Contractor is unable to meet the product demand, the Contractor shall notify LSCVAMC within 10 minutes of the telephoned request. To ensure patient care is not jeopardized, LSVAMC reserves the right to go to a secondary supplier in such case. (3) Emergency blood requirements will be made available within one hour after notification. LSCVAMC will arrange for emergency blood requirements to be picked up. C. Shipments: Shipments shall be F.O.B. Destination. The contractor is required to comply with Title 21 CFR as it pertains to the storing, packing and shipment of blood and blood products. D. Reference Laboratory Requirements (1) All requests for Reference Lab work will be initiated by LSCVAMC s Blood Bank. Requests will include patient information such as full name, full social security number and date of birth. As such, all Reference Lab work will be in compliance with the Health Insurance Portability and Accountability Act and incorporate privacy, security and sensitivity protections of health information. (2) The Reference Lab shall be accredited by the American Association of Blood Banks. (3) It shall provide 24-hour service for patient samples submitted for problem workups; shall report preliminary results by telephone after second person review, and shall FAX a preliminary report. A final report will follow in 7-10 calendar days. . (4) The Reference Lab will provide antigen screened, pheno-typically matched components when available upon request. Additional documentation for requested products and services will be submitted where applicable. 4. HOURS OF SERVICE The Contractor must be available, 24 hours per day, 365 days per year including Federal holidays. The following terms have the following meanings: Regular Delivery Schedule: Monday through Friday, 8:00 a. m. to 4:30 p.m. . Federal Holidays: The 10 holidays observed by the Federal Government are: New Year s Day Dr. Martin Luther King JR Birthday President s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Any other day specifically declared by the President of the United States to be a national holiday. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies. Note: Regular deliveries are not required on weekends or federal holidays; however, when the need for emergency delivery arises for weekends and federal holidays, the Contractor is required to be available to pack and ship the required products. 5. PAYMENT AND INVOICES A. Payment shall be made in accordance with FAR Clause 52.212-4(i). No advance payments are authorized under this contract. Payment will be made from certified invoices, with accuracy verified by the using service. B. Itemized invoices shall be submitted for payment of goods or services provided under this contract. Invoices shall include the following information: (1) Contractor s Name, Address and other identifying information (2) Contract Number and the VA Funding Document Number (3) Date(s) of Deliveries (4) Itemized list of Supplies or Services Furnished (5) Quantities, Unit Price, and Extension of each item to the degree that this information is compatible with the use of the Contractor s automated invoicing system. C. The Contractor s invoices will arrive four (4) times per month and will be accepted/rejected by the by COTR within 3 calendar days. If invoices are rejected, the COTR must provide a detailed explanation. 6. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS A. All Contractor employees who require access to the Department of Veterans Affairs computer systems and/or unescorted access to restricted areas of the LSCVAMC shall be the subject of a background investigation and must receive a favorable adjudication from VA Law Enforcement Training Center and the LSCVAMC s Information Security Officer prior to contract performance. This requirement is also applicable to all subcontractor personnel requiring the same access. B. Security Requirements for this Contract (1) Position Sensitivity: The position has been designated as Low Risk/Low Sensitivity. (2) Background Investigation: The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries (NACI). C. Contractor Responsibilities (1) The Contractor shall bear the expense of obtaining background investigations. If the Office of Personnel Management (OPM) conducts the investigation, the Contractor shall reimburse the DVA within 30 days. (2) The Contractor shall prescreen all personnel requiring unrestricted access to LSCVAMC and/or access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language. (3) The Contractor shall prepare and forward a listing of all Contractor personnel that will be performing services while on the property of LSCVAMC under this contract to the Contracting Officer for input into the Central Database for background investigations. Information required: Name (Last, First, Middle) Social Security Number (SSAN) Date of Birth (DOB) E-mail address where available Place of Birth (City, State (if foreign born, State will be FB), Country) Occupation (Position Title for the Contract) (4) The Contractor is invited to view information on VA s Background Investigation Policy at website: http://www.va.gov/PIVPROJECT/docs/applicationbrochure.doc. Failure to comply with the Contractor personnel security requirements may result in termination of the contract for default. D. Government Responsibilities 1. The Contracting Officer or Representative will input contractor information in the Central Database for Background Investigations. Each individual will receive via email or US Mail notification from VHALIT which will provide additional instructions. 2. The COTR is responsible for the payment for investigations conducted by the Office of Personnel Management in advance. In these instances, the contractor shall reimburse the LSCVAMC within thirty (30) days. A Bill of Collection will be prepared by the COTR and forwarded to the Contractor for payment. 3. Upon receipt of the notification of eligibility from the DVA Office of Security and Law Enforcement, Security and Investigations Center, the Contracting Officer or Representative will forward the Certificate of Eligibility to the LSCVAMC Information Security Officer to initiate the request to obtain access to the Department of Veteran s Affairs computer systems. 7. JOINT COMMISSION AND OTHER SPECIAL REQUIRMENTS The Contractor shall be responsible to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work. The contractor shall meet or exceed Federal regulations and/or standards. Responses to this notice shall be e-mailed to Ronetta Sweeney at contact@example.gov. Please provide your Dun and Bradstreet number and socio-economic status if you are interested in this contract. Telephone responses will not be accepted. Responses must be received in writing no later than 12:00 p.m., Friday, October 28, 2016. This notice is to assist the VA in determining sources only. A solicitation is not currently available. THE VA IS NOT SEEKING PRICING OR OFFERS OF ANY KIND. There is no guarantee, expressed or implicit, that the market research for this acquisition will result in a particular set-aside or sole source award, or any other guarantee of award strategy. All information is to be provided on a voluntary basis at no charge to the Government.