Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF APRIL 02, 2022 SAM #7428
SOURCES SOUGHT

Q -- RADIOPHARMACEUTICAL BASE +4 Option Years

Notice Date

3/31/2022 12:12:47 PM
 

Notice Type

Sources Sought
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

255-NETWORK CONTRACT OFFICE 15 (36C255) LEAVENWORTH KS 66048 USA
 

ZIP Code

66048
 

Solicitation Number

36C25522Q0220
 

Response Due

4/11/2022 9:00:00 AM
 

Archive Date

06/10/2022
 

Point of Contact

Emilio Ballentos, Contracting Officer, Phone: (913) 946-1981
 

E-Mail Address

Emilio.Ballentos@va.gov
(Emilio.Ballentos@va.gov)
 

Awardee

null
 

Description

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potential qualified businesses capable of providing the following: - RADIOPHARMACEUTICAL for the Eastern Kansas VA Medical Center This requirement is for Base and Four (4) Option Year *** See Statement of Requirement below for details *** If this is within your capability, please respond with the information below: Company Name Address Point of Contact Phone, Fax, and Email DUNS number GSA Contract (as applicable) Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.11 states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database. All Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) shall be verified in VetBiz at www.vip.vetbiz.gov. Point of Contact for this Sources Sought is: Emilio.ballentos@va.gov (913) 946 - 1981 Department of Veterans Affairs Network Contracting Office -15 3450 S. 4th Street Trafficway Leavenworth, KS. 66048.  STATEMENT OF WORK Radiopharmaceuticals VA Eastern Kansas Description/Specifications Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Nuclear Medicine Departments at Eastern Kansas Healthcare System Dwight D. Eisenhower VA Medical Center at 4101 South 4th Street Leavenworth, Ks. 66048 and Colmery O-Neil VA Medical Center at 2200 Gage Blvd., Topeka, KS 66622. Deliveries will be made Monday through Friday from 7:30 am to 3:00 pm.  Contractor shall provide emergency deliveries as requested by the VA Nuclear Medicine Departments. Personnel assigned by the contractor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. Because of the critical need of these supplies in a timely manner, only vendors within a 65-mile radius of the Topeka or Leavenworth, KS VA Medical Centers need to respond to this RFQ. 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 Department of Transportation (DOT), Department of Energy (DOE), Nuclear Regulatory Commission (NRC), and Interstate Commerce Commission (ICC) regulations and standards. Supplier shall hold a current unrevoked USNRC 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 VA Eastern Kansas Medical Center (EKVA) upon commencement of this contract. Supplier shall immediately notify EKVA 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. Used syringes will be returned to the pharmacy using the DOT regulations. Upon notification of contract award, Contractor will provide, in writing, within ten (10) days, the following information to the VA Medical Center: Contractor s regular work hours. Contractor s telephone number for call-in orders during regular work hours. Contractor s telephone number and instructions for placing Emergency orders after contractor s regular work hours, including weekends. Contractor s telephone number for expert advice concerning awarded products. 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 (TJC) and/or with the United States Pharmacopeia. Should any changes occur in the above information during contract performance period, contractor will provide updates in writing. 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 VA Eastern Kansas Medical Center. Contractor shall make their radiopharmaceutical quality control records available to the VA Eastern Kansas Medical Center upon written request from the Contracting Officer if needed. 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. Vendor must be able to provide the technetium from LEU (low enriched uranium), as well as all PET/CT doses as demonstrated in the associated description with one central billing location. If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%. 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: Provide technical expertise in calibration; Provide professional examination of product; submit results and recommendations to the Contacting Officer; Make expedient replacement of any product suspected of being deficient. PROCEDURE for labeling of patient's white blood cells (WBC) with Indium-111 Oxine or Tc-99m-Ceretec for re-injecting to the same patient: Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:00 PM for the next workday procedure. 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. The return by the Contractor, of the patient's labeled white blood cells will take place no later than within 5 (five) hours from the time of specimen pick up time. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's submitted for labeling procedure. Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule. Deliverables and Acceptance Criteria Contractor shall provide services, staff, and otherwise to do all things necessary for( or incidental) to the performance of work, as set forth below: Provide up to three deliveries per day during regular operating hours to EKVA. Deliver directly to the Nuclear Medicine Service at EKVA daily quantity of radiopharmaceuticals by 7:30 am, as requested from the previous day. Deliver directly to the Nuclear Medicine Service at EKVA quantity of radiopharmaceutical requested as needed/emergent basis to arrive within two (2) hour of notification. Deliveries occurring outside of working hours are directed to EKVA Police. Contractor will not have access to the Nuclear Medicine outside of working hours. Access to the Dwight D Eisenhower location during non-business hours shall be obtained by contacting the AOD located in the Emergency Department who will contact VA Police to accompany the delivery person to the Nuclear Medicine department and supervise the delivery. Access to the Nuclear Medicine department at Colmery O Neil will only be available during Nuclear Medicine department business hours. VA police will escort during non-business hours. Deliveries will be supervised by the COTR or their designee before beginning delivery operations. Contractor will contact the COTR prior to delivery to arrange for delivery supervision. 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. All shipments will have a Packing Slip enclosed, giving information about the product and its identification. 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: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30a.m. to 4:00 p.m. Normal Next Day Delivery: 7:30a.m. 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 Delivery Locations Eastern Kansas Health Care System Dwight D Eisenhower VA Medical Center Nuclear Medicine Department 4101 South 4th Street Leavenworth, Kansas 66048 Eastern Kansas Health Care System Colmery O Neil VA Medical Center Nuclear Medicine Department 2200 Gage Blvd. Topeka, Kansas 66602 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 nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist 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 EKVA Chief of Staff and approval by the EKVA Facility Director. Contractor Staff, Roles and Responsibilities Must be in compliance with all Nuclear Regulatory Commission (NRC), United States Pharmacopeia (USP), state, local and The Joint Commission (TJC) 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 of radiopharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts. List of Radiopharmaceuticals and estimated quantity   Item Description Estimated Quantity   Item #   Products (Unit Doses)         1 Tc99m Sodium Pertechnetate 140 2 Tc99m DTPA 40 3 Tc99m MAA 40 4 Tc99m Sulfur Colloid 30 5 Tc99m Mertiatide 15 6 Tc99m MDP 200 7 Tc99m Mebrofenin 40 8 Tc99m Sestamibi (Generic) 2,000 9 Tl-201 1 10 I-131 Diagnostic Capsule 20 11 I-131 Therapeutic 2 12 I-123 2 13 In-111 WBC Labeled/ Tc99m Ceretec Labeled WBC 2 14 In-111 Octreoscan 2 15 Ultratag RBC Kit 3 16 Co-57 Sheet Source 2 17 Co-57 Return Fee 2 18 Tc99m Sulfur Colloid Filtered 1 19 In111-DTPA GE Amersham 0 20 I-123 100uCi 0 21 I-123 200uCi 0 22 PYP vial 25 23 Sr-89 2 24 Sm-153 0 25 Stat during business hrs 1 26 Stat after business hours 1 27 PET F-18 780 28 PET F-18 Axumin 50 29 PET F-18 Amyvid 0 30 PET Ga-68 Dotatate 0 31 PET Cu-64 10 32 PET Ga-68 PMSA-11 15 33 PET F-18 Sodium Floride 10 34 Amino Protect (Amino Acid solution accompanying Lu-177 injections) 8 35 Lu-177 Lutathera 8
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/054f7018f82344299cdef2176634ef38/view)
 

Place of Performance

Address: Department of Veterans Affairs Colmery-O'Neal VA Medical Center 2200 SW Gage Blvd., Topeka, KS 66622-0001, USA

Zip Code: 66622-0001

Country: USA
 

Record

SN06286806-F 20220402/220331230114 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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