6505--Notice of Intent to Sole Source

NOTICE OF INTENT TO SOLE SOURCE The Department of Veterans Affairs, Veterans Integrated Service Network (VISN 4), Wilmington VA Medical Center is issuing this Notice of Intent (NOI) to inform industry contractors of the Government s intent to execute a Sole Source award IAW FAR 13.106-1(b)(1) and only one responsible source and no other supplies or services will satisfy agency requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1. Statement of Work The department of Pathology and Laboratory Medicine at the Department of Veterans Affairs Medical Center, 1601 Kirkwood Highway, Wilmington, DE, 19805, hereby referred to as the VAMC Wilmington, is seeking a contractual agreement with a Blood Supplier to supply blood and blood products for patient transfusions. Transfusions involve the infusion of blood donated from individuals to patients experiencing anemia caused by a variety of disease states, surgical procedures, and traumatic injuries. Human blood has a number of unique markers which match certain subsets of patients. Failure to sufficiently match these markers to the recipient (known as compatibility testing) may result in serious complications, including death. Blood and blood products have a limited life expectancy. This varies upon the product. In some cases, products may have a shelf life of a few days. Careful management of blood inventories is critical to maintain availability of viable blood/ blood products. Blood donations are collected and processed at Hospitals, or, in the absence of collection and processing capabilities, facilities designated as Blood Suppliers. The collection and processing of products is highly regulated by a number of independent regulatory agencies as well as the Food and Drug Administration to ensure the quality of blood and blood products. Because blood is a sterile body fluid and has the potential to harm patients if not correctly administered, blood and blood products are classed similarly to pharmaceuticals and may only be given under the direct supervision of a licensed Practioner. Blood Suppliers provide a complete menu of services to ensure blood and blood products are safe used efficiently. These services are part of the cost of the product supplied and include: Solicitation and maintenance of a volunteer donor pool. Collection of blood by a staff of highly trained personnel. Screening and tracking of donors. Performance of all regulatory agency indicated testing to ensure the safety of blood and blood products. Consultation with supplied facilities to maintain adequate quantities of products to meet the needs of patients. Rotation of product to ensure quality. Blood suppliers will update designated inventory levels to ensure products are fresh. Units returned to the Supplier will be redirected to other customers who are in need of product. Special testing and storage of blood and blood products for patients with unusual and/or varied incompatibilities. Managing recalls of blood and blood products due to collection, storage or product related problems. Hospitals utilizing Blood Suppliers will perform the majority of compatibility testing on site. Compatibility testing ensures a patient receiving a blood transfusion will experience minimal, if any, complications. Occasionally, some patients will have complex and varied compatibility needs. In these cases, Blood Suppliers may perform compatibility testing for the Hospital upon request and find compatible blood and/or blood products. OBJECTIVE: The VAMC Wilmington is seeking a base contract with four (4) available option renewal years. The awarded Blood Supplier must be able to supply a wide array of blood and blood products for routine and emergent transfusions. The awarded Blood Supplier must provide a wide range of testing options to assist the VAMC Wilmington find compatible blood and blood products for patients with special requirements. As this acquisition is for human blood, blood products and related services, the VAMC Wilmington is directly referencing the following FAR sections: (a) Without regard to FAR Part 6, if the health-care resource required is a commercial service, the use of medical equipment or space, or research, and is to be acquired from an institution affiliated with the Department in accordance with section 7302 of title 38 U.S.C., including medical practice groups and other approved entities associated with affiliated institutions (entities will be approved if determined legally to be associated with affiliated institutions), or from blood banks, organ banks, or research centers, the resource may be acquired on a sole source basis. (38 U.S.C. 8153) (b) Acquisition of health-care resources identified in paragraph (a) of this section are not required to be publicized as otherwise required by 873.108 or FAR 5.101. In addition, written justification, as otherwise set forth in section 303(f) of the Federal Property and Administration Services Act of 1949 (41 U.S.C. 253(f)) and FAR Part 6, is not required. (38 U.S.C. 8153) As such, the VAMC Wilmington is requesting a renewal of its existing Blood Supplier, New York Blood Center, Inc. dba The Blood Bank of Delmarva, 100 Hygeia Drive, Newark, DE 19713. MAJOR REQUIREMENTS: Blood Supplier Requirements Provision and maintenance of suitable blood, blood components, fractions, and derivatives to meet the transfusion needs of patients under treatment at the VAMC Wilmington in strict accordance with this contract. Provide serological workup services including Antigen Testing on blood products and patient blood samples, ABO/Rh testing, Antibody Screen and Antibody Identification Testing, Direct Antiglobulin Testing, and perform allo and auto absorptions, Sickle Cell Testing, DARA Patient Workups, RBC Molecular Genotyping, Eluates, and Compatibility Searches as requested by the VAMC Wilmington. Provide a means for patients to undergo autologous pre-operative donations at the Blood Supplier s location. Autologous blood will be processed and shipped to the VAMC Wilmington prior to the patient s surgical procedure. The patient s healthcare provider is responsible for ensuring patient safety and advising against autologous donation if physical risks to the patient are evident. Provide a means for family and friends of VAMC Wilmington patients to donate units of blood or blood components to be transfused to a specific patient (directed donation). Blood will be processed and shipped to the VAMC Wilmington for use by the indicated patient. Notify the VAMC Wilmington when a donor who has previously tested negative for markers of transfusion transmitted diseases tests positive for any marker. The awarded Blood Supplier must also notify the VAMC Wilmington upon discovery of donor s inaccurate response to any questions resulting in permanent or temporary deferral. Information must include unit identification numbers and shipment dates of any units shipped to the VAMC Wilmington. Remain up to date and provide access to with the most current methods of red blood cell preservation, compatibility, and safety. Provide a mechanism for verbal and written communication to document the VAMC Wilmington requests for blood and blood products. Examples of written communication include facsimile, secure online ordering platform, or electronic mail. If requested by the Blood Supplier, the VAMC Wilmington will provide a daily in-house inventory of status report. The Blood Supplier shall implement and maintain a quality control (QC) system that results in correction of potential and actual problems throughout the entire scope of contract performance. The QC system shall contain a mechanism for corrective actions without dependence upon government direction. Records of all Blood Supplier QC activities shall be maintained during the life of the contract. The Blood Supplier shall maintain a quality standard of 95% accuracy. Percentage is based on ratio of errors to deliveries. (Example: 60 deliveries/quarter, 3 errors: 3/60=0.05 or 5% errors. Accuracy is 95 %.) Errors are considered to be: Wrong blood product received Wrong ABO/Rh of blood product received Unavailability of requested product for more than 6 hours Inability to deliver requested product within required timeframe Deliveries that do not meet the TAT due to errors or omissions on the part of the VA and which are not correctable by the Blood Supplier are not counted against the Blood Supplier's performance. The Blood Supplier shall comply with the provisions of the Privacy Act of 1974, HIPAA and all applicable VA laws and regulations. Additional information to identify the patient and type of blood product or service needed will be provided by the VA Medical Center Blood Bank as needed. The Blood Supplier shall not maintain, in any form, any sensitive or patient identified information except as required by the FDA or AABB. The Blood Supplier shall comply with the Privacy Act and HIPAA as it pertains to general patient information, HIV, Drug and Alcohol Abuse, and Sickle Cell Anemia. The Blood Supplier shall have plant security and ADP security necessary to safeguard VA records. Billing from the Blood Supplier shall be made weekly in arrears. Full credit must be given for all products rotated through or returned by the VAMC Wilmington to the Blood Supplier in transfusable condition. This includes Standing Order red blood cells with equal to or less than fifteen days left on the expiration of the product and (fresh) frozen plasma and pooled cryoprecipitate with equal to or less than three months on the expiration date. The rotation or return of all other products will be based upon tranfusability. The Blood Supplier may deduct the cost of specialized testing for blood and blood products as agreed to by the VAMC Wilmington. Return credit Invoices shall provide sufficient detail to enable comparisons of billed units to the typed reports. Communication between both contract parties occur between the VA COR (refer to section 7. CONTRACTING OFFICER'S REPRESENTATIVE (COR) or designated alternate and the Blood Supplier s primary or alternate operations manager. Problems unresolved at this level will be referred to the VA contracting officer and the Blood Supplier's designated corporate officer. The Blood Supplier shall submit weekly invoices showing the number of units delivered, the number of units returned, and enumerated charges for all other services. Blood Supplier may set any schedule of work hours for its employees performing work at its own facility under this contract providing the VAMC Wilmington, DE TAT requirements are met; however, this will not affect the negotiated contract prices stated. Product Requirements Only blood from volunteer donors can be utilized using Food and Drug Administration (FDA) and AABB approved equipment and processes. All blood and blood products must be tested or treated for possible pathogenic contamination using methods approved by the FDA and AABB. This includes but is not limited to Nucleic Acid Testing (NAT) or pathogen reduction technology. All blood and blood products must be identified and labeled using ICCBBA s International Society of Blood Transfusion (ISBT) Code 128 symbology, which is the global standard for the terminology, identification, coding, and labeling of the medical products of human origin. The Blood Supplier will provide the VAMC Wilmington with new ISBT 128 product codes to validate prior to live distribution of the product. Supplied blood and blood products must meet industry and regulatory agency standards for volumes. Units must be preserved using approved additives. Red blood cells supplied must be exclusively leukoreduced and as fresh as possible (defined as the shortest possible time from collection to availability for distribution), but not over fifteen days old. With the exception of STAT RBC and blood product deliveries, RBC and blood products shall not be delivered with an expiration date of less than 10 days from the date received (excluding platelet products). For contractual purposes, product quantities are grouped into similar generic blood and blood product categories (i.e., Leukoreduced Red Blood Cells, Single Donor Platelet Apheresis, etc.) as names may vary within and between Blood Suppliers. Specially prepared Leukoreduced red blood cells must also be available to meet specific patient needs. This would include, but not limited to frozen deglycerolized, washed, or pre-treated to prevent GVHD (i.e., irradiated). Frozen Plasma products blood may be prepared as a fractionated product of blood donation or collected using automated apheresis processes. Donor pools should be exclusively male to eliminate the risk of Transfusion Related Acute Lung Injury (TRALI). If this is not possible, the Blood Supplier must implement additional screening and/ or testing processes to eliminate the risk of TRALI. This includes, but is not limited to, HLA antibody testing or more stringent screening criteria for female donors. Platelets must be collected using automated apheresis processes and supplied exclusively as single donor platelet apheresis in platelet additive solution (PAS) and abide by the FDA s bacterial risk control strategies protocol (i.e., pathogen reduction technology; LVDS). Exclusively supply pre-pooled Cryoprecipitate products. Specially prepared blood products, including, but not limited to crossmatched and HLA typed platelet apheresis. Due to the specific nature and limited transfusion of these products, the Blood Supplier may outsource or provide suitable alternatives, when appropriate. Delivery Requirements Provide delivery of all blood and blood products twenty-four (24) hours a day, seven (7) days a week, 365 days of the calendar year. Emergent or short turn around requests must be delivered to the VAMC Wilmington within two (2) hours of request. Adhere to a Pre-determined or standing delivery schedule of not less than three (3) deliveries per workweek (Monday, Wednesday, and Friday). This is used to maintain Standing order Inventory levels. Blood Supplier must be able to provide deliveries of requested blood outside of the standing delivery schedule as needed within two (2) to four (4) hours from the time of order. Each delivery necessitated to correct a delivery of incorrect or inadequate blood products shall be at no cost to the Government. Deliveries lost or damaged by the Blood Supplier shall be redone at no additional charge to the Government. The Blood Supplier shall send a letter to the COR and VAMC Wilmington Blood Bank Lead Technologist stating that the delivery was compromised and give the reason. In the event the Blood Supplier experiences a problem in making a delivery, e.g., delay in availability of requested product, delay in availability of driver to transport product within requested timeframe), the Contract Manager shall immediately contact the COR and identify the problem. The COR shall attempt to resolve problems as they arise. Blood Supplier shall maintain adequate resources necessary to ensure that delivery services for the VA are uninterrupted regardless of contingency or circumstance. The Blood Supplier shall provide all transport containers, coolers, supplies and equipment to maintain the transit temperature of blood and blood components within the limits required by the AABB. Pre-determined or Standing order requirements. The VAMC Wilmington requires blood and blood products be supplied by the Blood Supplier on a continuous basis to maintain the following inventory: Product Type Quantity (units) Leukoreduced Red Blood Cells O Positive 8 O Negative 5 A Positive 6 A Negative 2 B Positive 2 B Negative 2 AB Positive 0 AB Negative 0 (Fresh) Frozen Plasma O 6 A 6 B 6 AB 6 Pre-pooled Cryoprecipitate O 2 A 2 B 2 This schedule is based upon the current needs of the VAMC Wilmington. The Blood Supplier must change the Standing order as the needs of the VAMC Wilmington change. This includes adding new products, eliminating unneeded or underutilized products, or changing quantities based upon new or projected needs. Contract pricing and estimated usage The Independent Government Cost Estimate is written as a base contract with four (4) option renewals. Due to the variable costs in collecting and processing human blood, a five percent annual increase was applied to each product for each option year renewal. Product quantities are estimates only. The Government and the Blood Supplier understand and agree that the services to be delivered under this contract by the Blood Supplier to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Blood Supplier s employees. GOVERNMENT FURNISHED INFORMATION OR MATERIAL: This acquisition does not include Government-furnished property (GFP). This acquisition does not include Blood Supplier-acquired property (CAP). MEETINGS AND REVIEWS: Regular meetings at quarterly or other increments, as mutually agreed upon between the VA and the Blood Supplier. The Blood Supplier shall maintain an ongoing Training Plan and Quality Assurance Plan. The VAMC Wilmington reserves the right to periodically review training records for Blood Supplier's staff assigned to this contract, receive written documentation of any on-going quality improvement training provided to staff, and review copies of quality monitors performed on VA reports. TRAVEL REQUIREMENTS: Not applicable for this acquisition. CONTRACTING OFFICER'S REPRESENTATIVE (COR): The identified COR and technical representative for this acquisition is Joanna M. Bakanas MLS (ASCP)cm, Laboratory Manager, Pathology and Laboratory Medicine. Contact information, Phone 302-994-2511 ext. 4388 or email [email protected]. The identified alternate contact for this acquisition is Edyta U. Ryjewski, MT (ASCP), Lead Technologist, Blood Bank. Phone 302-994-2511 ext. 4229 or email, [email protected]. "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification." REPORTS/DELIVERABLES: All products must be delivered directly to the blood bank, located in the main facility (building 1). All incoming products will be inspected by the accepting blood bank technologist. Checks must include confirmation that the submitted order from the VAMC Wilmington was accurately filled, all unit numbers delivered match the unit numbers specified on the Blood Supplier s incoming shipping manifest, and a general temperature and visual inspection to ensure the products were shipped within specified ranges. Products not meeting the conditions and/or acceptability checks described in section 3.a and 8.b are returned with the Blood Supplier delivery personnel at no charge to the VAMC Wilmington. PERIOD OF SERVICE: The duration of this contract is one year from the date of execution. The VAMC Wilmington seeks the ability for four (4) option year renewals after the base year. BLOOD SUPPLIER QUALIFICATIONS: Must hold a current certification of accreditation under Clinical Laboratory Improvement Amendments (CLIA) 88, be accredited by AABB, and must be registered with the Food and Drug Administration (FDA). All policies and procedures must meet the requirements of the current FDA good manufacturing procedures and the current edition of the AABB Standards for Blood Banks and Transfusion Services. Noncompliance issues cited on FDA and AABB inspections must be addressed and corrected. The place of performance is Wilmington VAMC, 1601 Kirkwood Highway, Wilmington, DE 19805. This action will result in a Firm-Fixed Price Contract. The intended Contractor is Blood Bank of Delmarva. located at 100 Hygeia Dr Newark, DE 19713. The North American Industry Classification System (NAICS) for this requirement is, 621991, Blood and Organ Banks - Product of Service Code for this requirement is 6505, Drugs and Biologicals. The Small Business Administration (SBA) size standard for this sector is 32.5 million. This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available and telephone requests will not be honored. No award will be made based on unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling, and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government. The Government anticipates the award of a Firm-Fixed- Price contract. A determination by the Government whether to compete this proposed requirement based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competition. This notice of intent to award a sole source contract is not a request for competitive quotes. There will be no solicitation available for competitive quotes. Phone calls will not be accepted. This notice of intent is not a request for quotations. All Interested parties who are responsible, certified, and capable may express their interest by providing a capabilities statement NLT July 15, 2022, at 8:00 AM EST. The point of contact for this action is Contracting Officer, Debra Willard who can be reached at: [email protected].