Description
This is a Pre-Solicitation Notice for commercial items prepared in accordance with the subparts in Federal Acquisition Regulation 12 and 15. This is not a request for proposal. Electronic version of Solicitation number VA-249-11-RP-0192 will be published as a written solicitation on or about June 28, 2011. Electronic solicitation may be obtained FREE at the following URL: http://www.fedbizopps.gov/. No telephone will be accepted. Any amendments or additional information issued to this solicitation will also be available electronically at the URL address. Offerors are responsible for obtaining any and all amendments or additional information. The solicitation document and incorporated provisions and clauses will be in the actual solicitation document. The North American Industry Classification Systems (NAICS) code is 621991 size standard is $10 million. All proposals are to be submitted by to the designated office by 2:30 PM CST, July 27, 2011. Electronic responses are preferred. Product Description: Contractor will provide human blood components suitable for transfusion in accordance with methods stipulated in the current edition of Standards for Blood Banks and Transfusion Services and the American Association of Blood Banks (AABB) Technical Manual. The government anticipates awarding a contract for one base year October 1, 2011 thru September 30, 2012 with four (4) additional option periods. Each additional option period shall be contingent upon availability of next fiscal year funding. Delivery Location: Laboratory Room B-102, Cooper Division VA Medical Center 1101 Veterans Drive Lexington, Kentucky 40502 Product Estimated Annual Volume for Base year and each Option year Products Code Blood Product Annual Estimated Usage 42 RBC, ADENINE-SALINE 1 ea 47 RBC, ADENINE-SALINE,LEUKO-REDUCED 1750 ea 48 RBC, WASHED 1 ea 52 RBC, WASHED 1 ea 65 RBC, DEGLY, REJUVENATED 1 ea 64 RBC,FROZEN DEGLYCEOLIZED 1 ea 053/057 IRRADIATED/LEUKO-REDUCED PC 1 ea 433 AUTOLOGOUS BLOOD 1 ea 127 PLATELET, PHERESIS,LEUKO-REDUCED 120 ea 135 Plt, Pheresis, Leuko-reduced, Irr. 10 ea 133 Plt, Leuko-reduced, irr. 1 ea 123 PLATELETS 1 ea 443WASHED Units 1 ea 182 FRESH FROZEN PLASMA,REGULAR 50 ea 186 FRESH FROZEN PLASMA,REGULAR 1 ea 187 FRESH FROZEN PLASMA, LARGE >600ml 1 ea 101 CRYOPRECIPITATED 1 ea 237 CMV SURCHARGE 1 ea 448 HLA SURCHARGE 5 ea 451 NATIONAL SEARCH 1 ea 447 IRRADIATION CHARGE 1 ea 456 STAT CHARGE 50 ea 314 ANTIGEN TYPING 5 ea 330 ANTIGEN SURCHARGE (1 AG) 5 ea 331 ANTIGEN SURCHARGE (2 AG) 5 ea 332 ANTIGEN SURCHARGE (3AG) 5 ea 333 ANTIGEN SURCHARGE (4AG) 1 ea 335 ANTIGEN SURCHARGE (5AG) 1 ea 336 ANTIGEN SURCHARGE (6AG) 1 ea Pre-Pooled Cryo 5 ea 1. Requirements/Qualifications All blood and derivatives provided to patients in VA facilities must meet the requirements of the Food and Drug Administration (FDA). The blood supplier must have a quality program in place that meets the requirements of the current FDA good manufacturing regulations for finished blood products. a. The contractor's blood bank must be currently registered and/or licensed by the FDA, DHHS pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 260. NOTE: If interstate shipment of blood or blood components is involved, the contractor must have an authorized approval under Section 251 of the Public Health Service Act, as amended, 42 U.S.C. Section 262. b. Blood shall be typed for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the American Association of Blood Banks Technical Manual. (i) All blood and blood products will be free of gross hemolysis and clots. c. All blood/blood components shall be collected from donors in accordance with the requirements of the FDA. (i) In the event of a recall or lookback, copies of the request must be sent promptly to the Blood Bank Medical Director at the LEXINGTON VA Medical Center. (ii) The contractor will promptly notify the VA about potentially infectious blood or blood products. d. Specifically, contractor agrees that all components shipped will have been tested and found to be non-reactive for HBsAg, RPR, HBc antibody, antibodies to HIV-1, HIV-2, HCV, HTLV-1, and HIV-ag. e. Each unit of donor blood shall also be tested for alanine transferase (ALT). f. Blood and components shall not be used for transfusion if the ALT results are outside established limits. Additional tests may be implemented as appropriate. 2. References " Standards for Blood Banks and Transfusion Services American Association of Blood Banks (AABB) " Technical Manual American Association of Blood Banks (AABB) " VHA Handbook 1106.1 " College of American Pathologists (section checklist criteria) " Joint Commission Standards for Pathology & Clinical Laboratory Services " Food and Drug Administration (FDA) " HIPAA Regulations " Code of Federal Regulations (212) Section 606.120 and 606.121 Subpart G. " Code of Federal Regulations (21) Section 606.165 Subpart 1. " Code of Federal Regulations (21) Section 210 and 211. " The American Association of Blood Bank 27th Standards for Blood Bank and Transfusion Services. 3. Delivery/Location/Ordering a. The blood will be delivered to the Veteran Administration Medical Center, Lexington KY, (VAMC) laboratory in accordance with CFR (21), (212) and AABB 27th Edition as referenced above. Delivery Location: Laboratory Room B-102, Cooper Division, VA Medical Center, 1101 Veterans Drive, Lexington, Kentucky 40502. b. Vendor must provide routine exchange, at no extra cost, 7 days per week, of platelets to VAMC to ensure availability of product for our patients. - The rotation process of moving blood products to meet patient needs will minimize product outdating. - VAMC will be charged only for products used, with no hidden fees. - Additionally, VAMC will be credited "irradiation" fees when an irradiated product is used, but not required by the patient, due to limited inventory. - In case of emergency, the blood supplier must deliver additional platelets and all products within 1/2 hour of receiving the delivery order. - All blood units must be leukocyte-reduced c. All products must be free of gross hemolysis and be ISBT 128 coded products. d. Empty containers, blood, and equipment being returned for credit will be returned at Contractor's expense. e. The blood supplier will determine and implement a Blood Utilization Program to monitor the appropriate use of blood, promote patient safety and support cost containment. This program will be provided by vendor at no additional cost to our hospital. The contracting officer technical representative (COTR) will work with our facility to develop a process to monitor ongoing blood usage thereby, eliminating product wastage. f. The blood supplier must be available to accept delivery orders 24 hours a day, seven days a week. - The blood shall be delivered as specified within one hour of the request from the VAMC. This is considered a routine order. Emergency requirements are defined as deliveries to be made within 30 minutes following the request from the VAMC - Additional non-routine delivery orders will be accepted as needed. g. Specimen and blood components must be transported in such a way as to ensure the integrity of specimens and blood components, and comply with accreditation standards as defined by the FDA and the American Association of Blood Banks (AABB). h. The VAMC keeps one platelet pheresis in their inventory on a daily basis. If more platelets are needed they will be ordered for STAT delivery. There will be no delivery charge for these platelet deliveries. These STAT deliveries must be within 30 minutes of the initial contact call. i. Upon award, a list of VAMC employees of Pathology Service, who are authorized to place orders, will be furnished to the Contractor in the memo of designation of Contracting Officer's Representative(s). 4. Packaging, Marking, and Storage A. Blood shall be furnished labeled as to A, B, 0 and Rh type. Type A Rh negative and 0 Rh negative must have been drawn from donor not more than five (5) days before date on which purchase order is filled. j. Types such as AB Rh positive, B Rh negative, and AB Rh negative shall be supplied as fresh as possible but not over fifteen (15) days old. k. These time limits may be adjusted if a system for exchange on credit is provided which minimizes or precludes losses due to outdating. B. Immediately after collection, unless the blood is to be used as a source for platelets, the blood shall be refrigerated between 1 and 6 degrees Celsius with fluctuation of no more than 2 degrees Celsius within this range. l. Blood from which platelets are to be prepared shall be held in an environment maintained at a temperature range of 20 to 24 degrees Celsius until platelets are separated. m. Red blood cells shall then be placed in storage, within a maximum of 8 hours of bleeding, at a temperature from 1 to 6 degrees Celsius immediately after platelets are separated. n. This shall be in accordance with FDA and/or the AABB Standards for Blood Banks and Transfusion Services. o. Freezing must be avoided at all times. p. 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. q. If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10 degrees Celsius, preferably 1-6 degrees while in transit. 5. Progress and Compliance A. Offers shall be considered only from offerors whose blood bank 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 USC Section 260. B. Prior to award the offeror must submit proof that he 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 USC Section 262, as a source of supply for whole blood. (i) In the event that the contractor is a registered facility, proof must be provided that there have been no significant adverse findings noted during the last FDA inspection. C. If interstate shipment of blood or blood component is involved, the offeror must submit with the offer a statement that such approval has been authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262. D. The offeror certifies that he will comply with the requirements outlined below with respect to donors, containers, and delivery. E. Offers shall be considered only from blood banks that are able to provide the VAMC with 100% "volunteer donor" blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. r. 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." F. Donor Requirements: 1. Donor selection must be in accordance with criteria established by the FDA and/or the AABB. G. The Contractor shall assume complete responsibility for furnishing all blood components required by VAMC, Lexington, Kentucky. Blood components shall be drawn, processed, typed, and packed in suitable containers in accordance with all the terms, conditions, provisions, and schedule of this proposal. H. The supplies shall be provided upon receipt of an order received from an employee, authorized in writing, as a representative of the VAMC Contracting Officer. Twenty-four (24) hour daily coverage will be given by the Blood Center to fill emergency needs of the VAMC. Upon award, the names of VAMC employees authorized to place orders will be furnished to the Contractor with the designation as Contracting Officer's Representative. I. The VAMC will encourage blood donations. J. The VAMC will supply, daily, to the Blood Center a listing of all blood transfused by unit number and will report those same units weekly on a transfusion report form to be supplied by the Blood Center. Since blood service is on a consignment basis, the VAMC will release to the Blood Center any or all units not under cross-match on call from the Blood Center. Additionally, the VAMC will not be charged for unused blood. K. The VAMC will assume responsibility for all transfusion procedures, including cross-matching and compatibility testing. L. Contractor must have a twenty-four (24) hour Reference Lab available for service should the VAMC need to refer work. M. The VAMC will report all hemolytic transfusion reactions immediately after they occur. Any occurrence of jaundice or other blood-transmitted disease in patients subsequent to blood transfusion will also be reported. N. The VAMC will return plasma as well as any outdated blood, within three (3) days. O. There are local autologous and designated donation services for the veterans and the veteran's family. P. Local rare donor inventory is also provided to the VAMC. 6. Processing Fee and Invoicing a. The VA will pay directly from invoices sent which itemize charges by blood component or special products or services. b. Full credit will be given for damaged products such as fresh frozen plasma with broken bags or RBCs with clots. 7. JOINT COMMISSION (JC) AND OTHER SPECIAL REQUIREMENTS (JC standards are separate from clinical standards; therefore, this language does not apply to Physicians who are Credentialed and Privileged) Where the contract does not require JC accreditation or other regulatory requirements regarding worker competency, the Contractor must perform the required work in accordance with JC standards. The contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; includes knowledge and skills required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this solicitation; and listing of relevant continuing education for the last two years. The Contractor will provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the VA COTR, upon request, for each Contractor employee working on the contract. 8. SPECIFIC INSTRUCTIONS TO OFFERORS REGARDING SUBMITTION OF PROPOSAL Offerors proposals are to be submitted in two parts: (a) technical proposal and (b) Price. The offeror should include two copies (one original and one copy) two copies of the technical proposal and two copies of price proposal, and. Each proposal is to be submitted to the Contracting Officer. All responses shall be clearly marked with RFP # VA-249-11-RP-0192 in the subject block of your electronic response or at the lower left-hand corner of each mailed envelope. Mailed responses must be in one envelope and separately identified as "TECHNICAL PROPOSAL" or "PRICE PROPOSAL." The technical proposal shall address all elements listed with the exception of price. The technical proposal MUST NOT contain any reference to price.