Description
BLOOD PRODUCTS STATEMENT OF Pathology & Laboratory Medicine Service 1. Location : Louis Stokes Cleveland VA Medical Center, 10701East Boulevard, Cleveland, OH 44106, Clinical Support Care Line's Pathology & Laboratory Medicine Service 2. Order and Delivery: a. Orders will be either called in by phone or faxed to the vendor as needed. b. The vendor will deliver Blood Products to the Louis Stokes Cleveland VAMC on an on-call basis 24 hours per day. The Department operates a twenty-four hour seven day a week service. c. Vendor will provide limited deliveries at no cost to the VAMC based on a predetermined delivery schedule. All other deliveries of blood and blood components will be the responsibility of the Hospital. 3. Contact Persons: Linda DeBor, Business Manager, VISN 10 Clinical Support Services Care Line Business Manager, Acting Chief PALMS 216-791-3800, EXT. 4065and Therese Fitch, MT, ASCP, Supervisor, Blood Bank, 216-791-3800, EXT. 4083. Other employees of the PALMS Department are also available to accept deliveries of the Blood Products and By-Products during all 3 shifts. 4. Invoicing: Invoices are to be e-mailed to Therese Fitch once a week on a secured site. A code to log-on will be necessary for Therese and Linda. These invoices will be checked against the current inventories for accuracy. This will be checked by Linda DeBor and forwarded electronically to Fiscal to Austin for payment. 5. Additional Fees; The fees are to be included in the actual cost of the blood products and services. The lab fees may be different. These fees should be a separate line item. 6. Emergencies: Emergency procurement is not separate from the regular delivery service requirement since deliveries are on an on-call bases,24 hours a day 7 days a week. 5. Blood Products and Services To Be Provided: a. Reasonable efforts to procure for blood and by-products of all types. b. Deliveries to the VA Medical Center Cleveland on an on-call basis. c. In the event PALMS 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, PALMS shall notify the vendor of such events wherein deliveries can be made as soon as possible. d. With the exception of inabilities of deliveries of blood and blood by-products due to strikes, work stoppages, acts of government, Acts of God or other circumstances beyond the control of the contractor, the contractor is required to obtain products from other sources, contractor shall pay the incremental difference in cost between the price of the contractor's blood and blood-by-products and those of the subcontractor or other third party for which a delivery is made or other sources. Additionally, the contractor will reimburse Cleveland VAMC for reasonable costs associated with procuring such products. 6. Charges for Blood Products and Services; Processing/Service Fees a. The contractor will supply blood and blood-by-products, and other necessary service for the blood bank as outlined in this statement of work; provided to PALMS at the Cleveland VAMC. b. The Aggregate cost for The Aggregate Cost of the blood and blood by-products and services for the purpose of the Agreement are being determined by the level of services to the VAMC by the contractor. This service is to be review by the administrative staff of the VAMC before authorized payments are made for accuracy and fairness. c. Full Service" fees will be applied to the delivery and related services of the purchased blood and blood by-products to the PALMS at the Cleveland VAMC. d. Invoices are to be sent directly to the department for certification for payment to the attention of Teresa Fitch 7. Product Returns: a. Full credit will be given for all cellular products recalled by the contractor. Full credit will be issued for all AB(+) cellular returns within five days of expiration. 8. Regulatory Compliance and Other Responsibilities of the Contractor and Louis Stokes Cleveland VAMC: a. Contractor Obligations (1) Contractor agrees to provide blood and blood by-products that are processed (2) In the event of an Emergency Request, contractor's blood and blood by-products released prior to completion of testing will be handled according to state and federal regulations and the emergency release policy of the contractor as required by 21 CFR 640. (3) All of the Contractor's blood and blood by-products will meet the requirements of CBER, AABB standards and state and local law. ARCBS agrees to comply fully with applicable CBER requirements concerning the recruitment, collection, testing, labeling, storage, packaging and shipping of ARCBS Blood Products as described in 21 CFR Parts 600, 601, 607, 610, 640 and 660. (4) The contractor will properly package all blood and blood by-products and will include with each shipment an itemized shipping/packing list. (5) Other than in the case of an Emergency Request, contractor agrees to perform all tests required by the FDA prior to delivery of blood and blood by-products. (6) Contractors shall promptly notify Cleveland VAMC by telephone if the blood and blood by-products requested are not available in the quantity ordered. (7) The contractor shall have staff available 24 hours/day, seven (7) days/week including federal holidays, to receive and ship blood orders and serve as a contact for any other services needed. (8) The contractor will supply the Circular of Information for the Use of Human Blood and Blood Components (ARC 1751), to Cleveland VA Medical Center. (9) Contractor will notify Cleveland VAMC, in as timely a manner as is feasible, when information subsequently becomes available to indicate that a service has been provided which, based upon new information, and may affect a transfusion recipient. The contractor will not, however, divulge the identity of any donor of contractor's provided components. (10) Security Clearances for all persons coming on VA premises performing any type of work other than just delivery or attending meetings for any contractual work for the duration of the contract. This entails getting finger printed and having back ground checks. As required by 42 CFR Section 482.27(c) (2) (i) (ii), the contractor's blood and blood by-products services, located in the Northern Ohio Region, will notify the Cleveland VAMC, in a timely manner, of blood components forwarded to Cleveland VAMC may be at increased risk for the transmission of HIV, and other transfusion related viruses, and will provide confirmatory test results when such results are available. (11) The contractor shall provide a 24 hour Reference Lab. Routine fees shall apply during regular hours Monday through Friday 8:00a.m. - 8:00p.m. Other fees shall be applied at all other times (these fees may include overtime if it applies or half time for entitled employees). (12) There must be local autologous and designated donation services for the veterans. a. Cleveland VAMC Obligations: (1) Cleveland VAMC shall comply with all applicable federal, state and local laws, regulations and procedures pertaining to the practice of blood banking and transfusion medicine. (2) Hospital will comply with all pertinent requirements of Center for Biologics Evaluation Research (CBER) contained in Title 21 of the Code of Federal Regulations concerning the storing, packing and shipping of blood and blood products. (3) **Cleveland VAMC shall withhold levy charges to patients or third-party payers for any blood replacement charges, but only for the actual cost of providing the transfusion service to the patient.** (4) Cleveland VAMC shall report any life-threatening adverse reactions involving contractor's products to the contractor (and in writing if time allows) by telephone within 24 hours after such reaction and, if appropriate, make arrangements to have specimens of the patient's blood and the remaining portions of contractor's blood and blood by-products in question returned to contractor for testing. Hospital agrees to submit a written report to contractor describing in reasonable detail, and to assist in investigating, instances of post-transfusion hepatitis, post-transfusion HTLV-1 and infusion associated HIV infection. Hospital will report such instances to contractor within a reasonable period of time on forms provided by the contractor, as outlined in the contractor's manual for blood procedures. (5) Cleveland VAMC will inspect each shipment of contractor's blood and blood by- products upon delivery and notify the contractor immediately of any damage to the product caused by shipping or any abnormal appearance or other discrepancies. Cleveland VAMC shall inspect, maintain, and store the contractor's blood and blood by-products in a manner that ensures continued suitability for the intended use. Cleveland VAMC shall maintain proper refrigeration for the storage of contractor's blood and blood and blood by-products. Notwithstanding the first sentence of this subparagraph, should Hospital at any time determine for whatever reason that it has a question concerning the integrity of contractor's blood and blood by-products, it shall immediately contact the contractor and delay or suspend use of such contractor's blood and blood by-products. (6) Cleveland VAMC shall coordinate all uncross-matched blood or blood components not needed by Hospital for urgent use resides with ARCBS with the concurrence of Hospital. (7) Cleveland VAMC shall use blood and blood components only for its patient needs, unless transferred with the approval of the contractor. Blood with the shortest remaining shelf life should be used first, unless otherwise necessitated for specific medical reasons. In the interest of maximizing the blood resources in the region, the Cleveland VAMC may accept and utilize blood and blood components reissued by the contractor or transferred from another hospital/facility by the contractor. (8) Cleveland VAMC may allow the contractor access to certain documentation regarding blood and blood by-product purchasing information if necessary, if requested to do so by the contractor and according to CBI procedures. (9) Cleveland VAMC may not, under any circumstances, sell, barter, trade, or exchange contractor's blood and blood by-products for other services. (10) The contractor and Cleveland VAMC, upon a mutual understanding, may provide a forecast of an annual anticipated need of the Cleveland VAMC if a renewal is anticipated for the next fiscal year. (11) Cleveland VAMC may submit to the contractor a regionally-approved form for documenting product transfer to another care facility. Cleveland VAMC shall not transfer products that have not been stored strictly in accordance with this agreement. b. Security Clearances: The facility will informed employees of the contractor of the need to have security clearance to work on-site at the VA Medical Center. This will be done on the employees working at the Medical Center for any work relating to the contract during the duration of the contract. This does not apply to individuals doing delivery or pick-up or attending meetings that are not currently working on the premises.