SOLICITATION NOTICE
65 -- 693-20-1-086-0004 | Wilkes-Barre Radiopharmaceutical contract | EDA: TBD by Branch Chief | Current Milestone: TBD| Status:
- Notice Date
- 8/20/2019
- Notice Type
- Combine Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 4
- ZIP Code
- 19104
- Solicitation Number
- 36C24419Q1107
- Archive Date
- 10/19/2019
- Point of Contact
- +1 (215) 823-5800 X4919
- Small Business Set-Aside
- N/A
- Description
- THIS SPECIAL NOTICE IS NOT A REQUEST FOR QUOTES. This notice is for informational purposes only. This is a Sources Sought Notice 36C24419Q1106; is neither a solicitation nor a promise of future work. VA Wilkes-Barre VA Medical Center, 1111 East End Blvd, Wilkes-Barre, PA 18711-0030. Wilkes-Bares VA Medical Center is Seeking SDVOSB/VOSB and any SBS regardless of Socio-economic category that can deliver unit doses of radiopharmaceutical for Pet Scanning in accordance with the SOW. STATEMENT OF WORK Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA, on a daily and or as needed basis in accordance with this Statement of Work. Because of the critical need for these supplies in a timely manner, only contractors that can deliver in less than 15 minutes to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA need to respond to this Solicitation. Contractor shall be licensed by the State of Pennsylvania. Additionally, the Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides Delaware and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their proposal. Contractor shall provide evidence of delivery in less than 15 minutes with this Solicitation. Please identify the location of the point of shipment to the address listed on this Solicitation. Verification will be completed via www.mapquest.com. DESCRIPTION QTY Radiopharmaceutical contract for radiopharmaceuticals to perform various Nuclear Medicine procedures/treatments 12 2. 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 FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided. 3. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped. 4. Contractor shall label all products delivered as to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA with the radiopharmaceutical, activity, time of preparation, and expiration time and date. 5. Contractor shall hold a current unrevoked NRC and or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. Contractor shall provide a copy of their radioactive material license with their proposal. Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR), upon any action by the NRC or an agreement state and or FDA to suspend or modify the radioactive materials license. Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and applicable FDA requirements. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. 6. Contractor will provide with their proposal, the following information: 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 to include 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 (JC) and or with the United States Pharmacopeia. f. Should any changes occur in the above information during the contract period of performance, contractor will immediately provide updates in writing. 7. Current package inserts of all radiopharmaceuticals supplied under the awarded contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR Wilkes-Barre VA Medical Center in Wilkes-Barre, PA Nuclear Medicine Service. 8. Contractor shall make quality control records available to the COR upon written request from the CO or COR. 9. Contractor shall test all products for quality control. Periodically, this testing shall be performed at no cost to the Government. The contractor shall provide a detailed description of the test upon request. 10. Calibration time for each requested radiopharmaceutical is given in the Schedule of Supplies, 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. 11. If an ordered dosage of radioactive material is given to Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%. 12. Technetium product radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit will be reflected in the current month s invoice. 13. Contractor shall replace any items delivered damaged or in error at no cost to the Government. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with the needs of the patient. 14. 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. 15. In the event that a quality control or material defect is suspected or detected by the COR, the Contractor will be required to provide any consultation necessary to alleviate any said suspicion or defect by the following: a. Provide technical expertise in calibration; b. Provide professional examination of product; submit results and recommendations to the COR; c. Make expedient replacement of any product suspected of being deficient. 16. Procedure for labeling of patient's White Blood Cells (WBC) with Indium-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 2:00 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 7:30 AM or later, if so specified by the COR. 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. 17. Contractor shall pick up Radiopharmaceuticals (used or unused) for proper disposal at no cost to the Government. 18. Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies. D. Deliverables and Acceptance Criteria 1. Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below: a. Provide up to two deliveries per day during regular operating hours to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA at 7:30am and 9:30am at no additional charge followed by a third delivery if necessary. The fourth delivery of the day will be considered an emergency. b. Orders can be placed orally by telephone or fax transmission by ordering officers provided by the Contracting Officer Representative. c. Deliver directly to the Nuclear Medicine Service Wilkes-Barre VA Medical Center in Wilkes-Barre, PA quantity of radiopharmaceutical requested on an as needed or emergent basis to arrive in less than 15 minutes after notification. 2. If Monday is a federal holiday, no deliveries will be expected. Holidays are listed under section E. 3. Record tracking: Contractor will provide an electronic Nuclear Medicine Information System (NMIS) and all relevant upgrades/repairs available to the Nuclear Medicine department for patient dose record tracking. Daily dose administration reports generated by the NMIS will be returned to Contractor. E. VA OPERATING HOURS The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. 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 below. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30 AM to 4:30 PM. Deliveries shall be accomplished by 7:30 AM and on an as needed basis during normal operating hours. 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, Christmas, and any other day specifically declared by the President of the United States to be a national holiday. Pricing: Items will be in unit dose and on an as needed basis in accordance with patient care requirements. Key Assumptions: All annual quantities are estimates. The contractor will only be paid for items and quantities actually ordered and delivered. Responses shall be submitted electronically, via email to Louellen Butler at Louellen.Butler@va.gov due no later than Friday 08-23-2019 at 1:00 pm. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (20-AUG-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
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Link To Document
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/36C24419Q1107/listing.html)
- Record
- SN05411787-F 20190822/190820230046 (fbodaily.com)
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