FBODaily.com | FedBizOpps: FILE | 65 | RADIOPHARMACEUTICALS-PB Base Plus One Option - Attachment

FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 23, 2014 FBO #4474
DOCUMENT

65 -- RADIOPHARMACEUTICALS-PB Base Plus One Option - Attachment

Notice Date: 2/21/2014
Notice Type: Attachment
NAICS: 325412 — Pharmaceutical Preparation Manufacturing
Contracting Office: Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street;Leavenworth KS 66048
ZIP Code: 66048
Solicitation Number: VA25514Q0538
Response Due: 2/27/2014
Archive Date: 5/28/2014
Point of Contact: rickie.fearing@va.gov
E-Mail Address: RICKIE.FEARING@VA.GOV
(RICKIE.FEARING@VA.GOV)
Small Business Set-Aside: Total Small Business
Description: Statement of Requirements Description/Specifications 1.Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Popular Bluff VA Medical Center, Popular Bluff, MO located at 1500 N Westwood Blvd Poplar Bluff, MO 63901-3318 on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors within a 50-mile radius of the VA Popular Bluff, MO need to respond to this RFQ. 2.Contractor agrees to provide all needed radiopharmaceuticals as identified in the Bid/Price Schedule to VA Medical Center on a daily and/or as needed basis per this Statement of Work. 3.Nuclear Medicine Information System (NMIS): At no additional cost to the Government, the Contractor shall furnish, and support NMIS software for the management of VA patient doses, radiation safety, and quality control. If the Contractor system varies from the current NMIS information system, the Contractor shall provide data migration at no additional cost to the Government. 4.Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, US NRC, and ICC regulations and standards. 5.Supplier shall hold a current unrevoked US NRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service at VAMC Poplar Bluff upon commencement of this contract. Supplier shall immediately notify the VAMC, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer's package inserts. 6.The contractor shall remove all radioactive waste, including all syringes and vials no longer required. All waste shall be returned (picked-up) the next working day. The contractor shall supply the "secure system" for the prevention of needle sticks and possible biohazard and radioactive contamination of reusable lead container. 7.Technetium product radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. 8.Upon notification of contract award, Contractor will provide, in writing, within ten (10) days, the following information to the VA Medical Center: a.Contractor's regular work hours b.Contractor's telephone number for call-in orders during regular work hours. c.Contractor's telephone number and instructions for placing "Emergency" orders after contractor's regular work hours, including weekends. d.Contractor's telephone number for expert advice concerning awarded products. e.Contractor will furnish a statement that any radiopharmaceuticals delivered as "ready-to-use" (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and/or with the United States Pharmacopeia. f.Should any changes occur in above information during contract performance period, contractor will provide updates in writing. 9.Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at Poplar Bluff VA Medical Center. 10.Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer. 11.Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery. 12.The quantity of radioactivity for supplied radiopharmaceuticals shall not change more than +10% or -5% at the time of calibration, from the quantities specified. 13.The expiration date and time shall be indicated and affixed to each product as noted below; in general: a. Ready-to-use doses: not shorter than six (6) hours. b.Tc-99m Pertechnetate: Not shorter than twelve (12) hours. c.Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery. d.Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span. 14.In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: a.Provide technical expertise in calibration; b.Provide professional examination of product; submit results and recommendations to the Contacting Officer; c.Make expedient replacement of any product suspected of being deficient. 15.PROCEDURE for labeling of patient's white blood cells (WBC) with Indium IN-111 Oxine or Tc-Ceretec for re-injecting to the same patient: a.Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:00 PM for the next workday procedure. b.Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Contractor will be at 8:00 AM or later, if so specified by the COTR. c.The return by the Contractor, of the patient's Indium labeled white blood cells will take place not later than within 5 (five) hours from the time of specimen pick up time. d.Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure. 16.Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule. Deliverables and Acceptance Criteria 1.Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below: a.Deliver directly to the Nuclear Medicine Service at VAMC Poplar Bluff daily quantity of radiopharmaceuticals by 7:15 am, as requested from the previous day. b.Deliver directly to the Nuclear Medicine Service at VAMC Poplar Bluff quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within one (1) hour of notification. c.Other delivery times may be outlined by individual the VAMC under this contract. 2.If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular work day. Holidays are listed herein. 3.Shipments "called when needed" may be requested during regular work hours, or after, as "emergency", including weekends, holidays and nights. 4.Shipments requested as an "Emergency" will be delivered as follows: a.Requests placed after regular work hours (weekend, holiday, and night) will be delivered within three (3) hours, or as specified. b.Emergency, weekend and holiday shipments are to be delivered to location(s) specified by each facility, unless otherwise specified when called for. c.All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations. d.All Radiopharmaceuticals, Radioassay Kits and/or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws. e.Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by each VAMC under this contract, will be strictly adhered to. 5.All shipments will have a Packing Slip enclosed, giving information about the product and it's identification, plus (for billing purposes) the VA Medical Center's Purchase Order Number issued for the current fiscal quarter or month, and possible the Contractor's invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.) Work Hours The delivery of products provided by this contract shall be furnished by the contractor. The contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and (2) below. The following terms have the following meanings: (1)Normal Operating hours of the hospital: Monday through Friday, 8:00a.m. to 4:30 p.m. (2)Normal Next Day Delivery: 7:15a.m. (3)National Holidays: The ten holidays observed by the Federal Government are: New Year's Day, Martin Luther King's Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday Term of Contract This contract is effective for one year with the possibility of one (1) option year. The period of performance is from March 15, 2014 through March 14, 2016. The contract and option year are subject to the availability of VA funds. Compensation and Payment Products covered under this contract are listed in the Bid/Price Schedule. Payment method and invoicing instructions are listed within the Contract. Personnel Policy The contractor is responsible for all costs, including personnel costs, associated with this contract. Qualifications Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director. Contractor Staff, Roles and Responsibilities Must be in compliance with all NRC, USP, state, local and JCAHO guidelines. Contractor Performance Assessments Assessments. The Government may do assessments of the Contractor's performance. The Contractor shall have an opportunity to respond to assessments. Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection radio-pharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts. BID/PRICE SCHEDULE (Base Year) Item DescriptionEstimated Quantity Contractor's Unit Price Total Estimated Cost (Estimated Quantity X Contractor's Unit Price) Technetium Products (Unit Doses) Sodium Pertechnetate (UP TO 30 mCi)30 Sodium Pertechnetate Bulk mCi500 Tc-99m Mebrofenin50 Tc-99m DTPA Aerosol10 Sources (TcO4)52 Tc-99m MAA60 Tc-99m MDP240 Tc-99m MAG 330 Tc-99m MAG 3 (Second dose)30 Tc-99m MAG 3 (Captopril procedure)20 Tc-99m Sulfur Colloid24 Tc-99m DTPA renal5 Tc-99m Sestamibi (1 to 45mCi) 1250 Tc-99m Ceretec5 Tc-99m HMPAO Leukocyte (up to 25 mCi)5 Long Lived Radiopharmaceuticals (Unit Doses) Thallium-201 (per mCi)100 mCi Gallium-675 Iodine-123 100 uCi10 Iodine-123 200 uCi26 In-111 Leukocytes (500 uCi dose)20 Xe-133 (20mCi vial)100 Cold Vials MEBROFENIN5 DPTA5 MDP5 MAA5 Ultra Tagg RBC5 DELIVERY CHARGE (4 deliveries during hours)260 DELIVERY CHARGE OVER 4 PER DAY0 EMERGENCY DELIVERY CHG (after hours)36 Total for Base Year (Estimated) (Option Year 1) Item DescriptionEstimated Quantity Contractor's Unit Price Total Estimated Cost (Estimated Quantity X Contractor's Unit Price) Technetium Products (Unit Doses) Sodium Pertechnetate (UP TO 30 mCi)30 Sodium Pertechnetate Bulk mCi500 Tc-99m Mebrofenin50 Tc-99m DTPA Aerosol10 Sources (TcO4)52 Tc-99m MAA60 Tc-99m MDP240 Tc-99m MAG 330 Tc-99m MAG 3 (Second dose)30 Tc-99m MAG 3 (Captopril procedure)20 Tc-99m Sulfur Colloid24 Tc-99m DTPA renal5 Tc-99m Sestamibi (1 to 45mCi) 1250 Tc-99m Ceretec5 Tc-99m HMPAO Leukocyte (up to 25 mCi)5 Long Lived Radiopharmaceuticals (Unit Doses) Thallium-201 (per mCi)100 mCi Gallium-675 Iodine-123 100 uCi10 Iodine-123 200 uCi26 In-111 Leukocytes (500 uCi dose)20 Xe-133 (20mCi vial)100 Cold Vials MEBROFENIN5 DPTA5 MDP5 MAA5 Ultra Tagg RBC5 DELIVERY CHARGE (4 deliveries during hours)260 DELIVERY CHARGE OVER 4 PER DAY0 EMERGENCY DELIVERY CHG (after hours)36 Total for Option Year One (Estimated) TOTAL FOR BASE PLUS ONE OPTION (ESTIMATED) Products Sources: Description: 50uCI Co-57 source Part Number: PHI-0 124 Amount: 1 each Description: 10 mCi Gd-153 Symbia Source Part Number: HEGL-0 133 Amount: 1 each Description: 15 mC1 Co-57 Flood Source Part Number: SFL-24RH-057-ISM Amount: 1 each Description: 5 mC1 Co-57 Reference Vial Part Number: SRV-057-5M Amount: 1 each For the above items: Lead time one (I) week to ten (10) days, Freight included in price. Description: Survey Meter Calibration Instruments: Ludlum Models 3,14C and Bicron Model 2000 Amount: 4 meters per year Description: Survey Meter Calibration Instrument: SE International Model INSPECTOR EXP Amount: 1 meter per year
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25514Q0538/listing.html)
Document(s): Attachment; File Name: VA255-14-Q-0538 VA255-14-Q-0538_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1217635&FileName=VA255-14-Q-0538-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1217635&FileName=VA255-14-Q-0538-000.docx; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Record: SN03294134-W 20140223/140221235104-91208790dd5c9fa459b3a3e4e3b4f79d (fbodaily.com)
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65 -- RADIOPHARMACEUTICALS-PB Base Plus One Option - Attachment