DOCUMENT
Q -- Radiopharmaceutical supplies and services for the Charlie Norwood VA Medical Center (CNVAMC) in Augusta, GA. - Attachment
- Notice Date
- 9/5/2018
- Notice Type
- Attachment
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;VISN 7 Network Contracting Office;LaVista Business Park - Bldg A;2008 Weems Road;Tucker GA 30084
- ZIP Code
- 30084
- Solicitation Number
- 36C24718Q9535
- Response Due
- 9/7/2018
- Archive Date
- 10/7/2018
- Point of Contact
- gail.bargaineer2@va.gov
- E-Mail Address
-
Gail.Bargaineer2@va.gov
(gail.bargaineer2@va.gov)
- Small Business Set-Aside
- Service-Disabled Veteran-Owned Small Business
- Description
- Price Impact THIS IS A SMALL BUSINESS SOURCES SOUGHT NOTICE REPRESENTING A MARKET SURVEY AND IS NOT A REQUEST FOR PROPOSALS, PROPOSAL ABSTRACTS, QUOTATIONS OR INVITATION FOR BIDS The Department of Veterans Affairs VISN 7 Network Contracting Activity is conducting a MARKET SURVEY to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are Service-Disabled Veteran-Owned, Veteran-Owned, Small Business, HUB Zone 8(a), Women-Owned, or small disadvantaged business concerns; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Small business concerns should be capable of furnishing all labor and materials/parts as requested to provide Radiopharmaceutical supplies and services for the Charlie Norwood VA Medical Center (CNVAMC) in Augusta, GA. The NAICS code is 325412, with a size standard of 750. Note: Aside from identifying small business concerns capable of satisfying Agency needs, we are trying to determine (1) current commercial practices (2) considerations for needed services (3) any other relevant information with regards to providing such services. With that, industry is asked to clearly identify where responses are specific to an individual service, i.e., wheelchair or stretcher. Also, please provide definitions where terms used are different from what is found in the Federal Acquisition Regulation (FAR) and general usage dictionaries. DESCRIPTION OF THE REQUIREMENT: The Contractor shall provide all unit dose Radiopharmaceuticals used by the Nuclear Medicine Imaging Department, Charlie Norwood VA Medical Center, Augusta Georgia during normal working hours and for all after hour emergency studies. Background: The Charlie Norwood VA Medical Center in Augusta, Georgia has a continuous need for Radiopharmaceutical / Nuclear medicine supplies and delivery services. Diagnostic radioactive isotopes have a short shelf life and must be delivered daily and in case of emergent patient orders. Doses are ordered specific for each patient study. The use of a CNVAMC has historically awarded to a Contractor that provides the Radiopharmaceutical doses that are compounded and calibrated by or under the supervision of a certified Nuclear Medicine, hardware, software, training, shipping and removal of all used and unused radiopharmaceutical doses. Performance Period: Firm-Fixed-Price. One Base year with four option years. The Contractor shall complete the work required under this SOW in 365 calendar days from date of award, unless otherwise directed by the Contracting Officer (CO). The Contractor shall provide Radiopharmaceuticals during standard hours of care Monday through Friday from 0700 (7:00 AM PST) until 1630 hours (4:30 PM PST), including Federal holidays. After hours coverage will be available Saturday and Sunday 0700 (7:00 AM PST) until 1630 (4:30 PST) and Monday through Sunday from 1630 (4:30 PM PST) until 0730 hours (7:30 AM PST), including Federal holidays. Base Year 01 October 2018 September 30th, 2019 1st Option 01 October 2019 September 30th, 2020 2nd Option 01 October 2020 September 30th, 2021 3rd Option 01 October 2021 September 30th, 2022 4th Option 01 October 2022 September 30th, 2023 Place of Performance: Nuclear Medicine, Imaging, 950 15th Street, Augusta, Georgia 30904 Type of Contract: Firm-Fixed-Price. Radiopharmaceutical Description: ****Note**** All Technetium-99m (Tc-99m) shall be procured from NON-HIGH ENRICHED URANIUM (HEU) companies supplies when available. HEU s shall be accepted in the event NON-HEU s are not available. GENERAL REQUIREMENTS 1. The Contractor must be able to deliver within 1 hour of receipt of a request for those radioisotopes listed in the Schedule which have a limited shelf life. The Contractor will deliver the ordered Radiopharmaceutical doses to the Nuclear Medicine before 0730 (7:30 AM PST) on the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel. The Contractor shall deliver the radiopharmaceuticals provided in the Schedule/Price Sheet to the Nuclear Medicine Department no more than two hours after the order has been placed. Orders may be placed orally, in writing, or by electronic means. Specific personnel authorized to place orders under this contract will be designated in writing upon award of the contract. 2. The Contractor will deliver all after hour orders of Radiopharmaceuticals within two hours of the Radiopharmaceutical doses being ordered to Imaging Nuclear Medicine. 3. The Contractor will calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose based on specific requirements provided by Nuclear Medicine Clinic based on guidelines outlined in 10 CFR Part 35. 4. The Contractor shall provide a daily invoice accompanying all Radiopharmaceutical shipments to Imaging Nuclear Medicine for all orders placed. 5. The Contractor will ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Medicine Pharmacist. 6. The Contractor shall provide verification of a valid radioactive materials license issued by the Georgia State Department of Health/Division of Radiological Health or the U.S. Nuclear Regulatory Commission. Proof of such licensure will be considered as verification that the Contractor has approved distribution procedures in place to ensure security of radioisotopes during receipt, preparation and delivery, as well as required training for delivery personnel and any others that may come in contact with radiopharmaceuticals. The Contractor shall be prepared in accordance with state and federal regulations governing the receipt, handling, preparation and delivery of these isotopes for human use. All couriers shall be licensed and shall submit all required paperwork to be granted access to the Charlie Norwood VA Medical Center, Augusta Georgia. The Contractor shall be responsible for the removal of all used and unused radiopharmaceutical doses from the clinic within 72 hours of delivery. 7. The Contractor shall notify the Charlie Norwood VA Medical Center Imaging Department, Nuclear Medicine immediately should the inability arise to provide Radiopharmaceutical doses. 8. The Schedule contained herein lists the most commonly used radioactive isotopes, with the estimated quantities for each contract period. If a previously provided radioisotope did not meet Quality Control (QC) standards for imaging purposes, for reasons such as, but not limited to, (1) unstable diagnostic results (2) repeat imaging/treatment or (3) a delay inpatient services. The Contractor shall provide its Quality Management Program (QMP), this program shall include, but not be limited to: The Contractors procedure for the preparation of radiopharmaceuticals The location and USP 797 level of radiopharmaceutical preparation QC guidelines the Contractor follows for the dispensing of radiopharmaceuticals for human use verification of the steps followed to test labeling efficiency of radiopharmaceutical kits and the frequency of this testing. (such as FDA and/or professional standards or guidelines) in determining expiration time or date on radiopharmaceuticals Contractor shall be OSHA compliant. OSHA needle stick legislation requires that healthcare facilities must: Annually update their Exposure Control Plan (ECP) Use appropriate sharps devices or needless systems Solicit frontline employee input to assist in the identification, evaluation and selection of modern technology Establish sharps injury log to better track needle sticks and Contractor shall meet applicable regulatory requirements for USP,USP, USP and cGMP Part 212. Ensure the integrity of each prescription by complying with stringent internal quality processes and standard operating procedures. Offer quality and safety related continuing education courses on USP, cGMP and radiation safety principles. Utilize safety products, to protect against needle sticks and contamination from blood borne pathogens, and use adequate syringe shields, to reduce radiation exposure. D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: The Contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW. Task One: The Contractor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists stationed at the Charlie Norwood VA Medical Center. Deliverable One: Provide training as needed or as scheduled with the COTR. Task Two: The Contractor shall be able to provide a Nuclear Medicine management program. This program shall provide all necessary software and hardware maintained by the Contractor. The management program shall allow for the receipt, inventory and proper documentation of Radiopharmaceutical doses dispensed. Deliverable Two: Provide software and hardware to manage radiopharmaceutical supplies and services. E. EVALUATED OPTIONAL TASKS AND ASSOCIATED DELIVERABLES Optional Task One: None SCHEDULE FOR DELIVERABLES 1. If for any reason any deliverable cannot be delivered within the scheduled time frame, the Contractor is required to explain why in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response, in accordance with applicable regulations. G. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor. H. REPORTING REQUIREMENTS The Contractor shall provide a monthly invoice accompanying all Radiopharmaceutical shipments to Imaging Nuclear Medicine for all orders placed. Monthly invoices for payment shall be transmitted electronically. A properly prepared invoice will contain: Invoice Number and Date Contractor s Name and Address Accurate Purchase Order Number Supply or Service provided Total amount due I. TRAVEL Travel or courier service is expected to and from the CNVAMC site and Contractor s location. The Contractor will deliver all after hour orders of Radiopharmaceuticals within two hours of the Radiopharmaceutical doses being ordered to Imaging Nuclear Medicine. The Contractor shall provide a daily invoice accompanying all Radiopharmaceutical shipments to Imaging Nuclear Medicine for all orders placed. J. GOVERNMENT RESPONSIBILITIES The Contractor will be contacted by Staff, Nuclear Medicine Technologists assigned to the Imaging Nuclear Medicine Department at the Charlie Norwood VA Medical Center. All routine orders for Radiopharmaceutical doses will be placed to the Contractor the day prior before the clinic close of business via phone. The order will include specified activities of doses and calibration times. All emergency, after hour orders of Radiopharmaceutical doses will be placed by an on-call staff Nuclear Medicine Technologists on an emergency need basis. K. CONTRACTOR EXPERIENCE REQUIREMENTS The government will determine on a SR basis what positions are considered key personnel. The Contractor shall identify, by name, the key management and technical personnel who will work under this task order at the time the work is being negotiated. If a key person becomes unavailable to complete the SR, the proposed Substitutions of key personnel shall be made only as approved directed by the Contracting Officer and the COTR. The government will not dictate specific experience and education requirements of the employees initially proposed to perform the work stated herein. The Contractor shall submit a resume of qualifications for the COTR and all other direct employees proposed for the project. All Contractor employees will be approved by the COTR prior to bringing on duty. If, at any time from date of award to the end of the contract, non-key personnel Contractor personnel are no longer available, HES/HIS reserves the right to review the qualifications of the proposed replacement personnel and to reject individuals who do not meet the qualifications set forth in the TLO. Team personnel proposed by the Contractor should possess some of the following knowledge and/or skills: The Contractor must notify VHA in advance and we will approve or reject proposed Contractor key personnel for the performance of this contract. The Contractor shall submit a resume of qualifications to the COTR for key personnel and all other direct employees proposed for the project. All Contractor employees will be approved by the COTR prior to bringing on duty. If, at any time from date of award to the end of the contract, Contractor personnel are no longer available, the VHA will approve the qualifications of proposed replacement personnel and will reject individuals who do not meet qualifications set forth herein. The Contractor must inform the VHA COTR, and Project Manager/Task Manager when personnel are removed from the contract for any reason. The Contractor shall remove any employee from the performance of this contract within five (5) workdays of receiving notice from the Contracting Officer that the employee's performance is unsatisfactory. All Contractor employees are subject to immediate removal from performance of this contract when they are involved in a violation of the law, VA security, confidentiality requirements and/or other disciplinary reasons. The Contractor must inform the VHA COTR, and Project Manager/Task Manager when personnel are removed from the contract for any reason. If a key person becomes unavailable to complete the SR, proposed Substitutions of key personnel shall be made only if approved by the COTR and Project Manager. The Contractor shall submit a resume of qualifications to the COTR for all direct employees proposed for the project. All Contractor employees will be approved by the COTR prior to bringing on duty. L. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the Contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO after the task order. 2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the Contractor. Any request for information relating to this task order, presented to the Contractor, shall be submitted to the CO for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS All Contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to sub Contractor personnel requiring the same access. Position Sensitivity The position sensitivity has been designated as, _____ ____ (Insert High Risk, Moderate Risk or Low Risk.) Background Investigation The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. Contractor Responsibilities The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship, and are able to read, write, speak and understand the English language. The Contractor shall submit or have their employees submit the required forms (SF 86 or SF 85P, SF 85P-S, FD 258, Contractor Fingerprint Chart, VA Form 0710, Authority for Release of Information Form, and Optional Forms 306 and 612) to the VA Office of Security and Law Enforcement within 30 days of receipt. The Contractor, when notified of an unfavorable determination by the Government, shall withdraw the affected employee from working under the contract. Failure to comply with Contractor personnel security requirements may result in termination of the contract for default. 4. Government Responsibilities The VA Office of Security and Law Enforcement will provide the necessary forms to the Contractor, or to the Contractor s employees, after receiving a list of names and addresses. Upon receipt, the VA Office of Security and Law Enforcement will review completed forms for accuracy, and forward the forms to the office of Personnel Management (OPM) to conduct background investigations. The VA Office of Security and Law Enforcement will notify the CO, and Contractor, of adjudication results received from OMB. Upon being notified about a favorable determination, the CO may issue a notice to proceed to the Contractor. MANAGEMENT AND DELIVERY The Management and Delivery factor will be evaluated based upon an assessment of the Offeror s quality assurance and contract performance plan. Offeror s Management and delivery proposal shall address the following considerations: Offeror s shall provide policy or plan regarding ability to provide unit dose add-on doses within 30 minutes or less, same day or next day iodine capsules add-on, on-call services, established weekend operations to provide FDG (PET-CT) doses within 30 minutes; Ability to provide by-product material or cyclotron produced materials manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of federal Regulations, Part 35 and the equivalent regulations of an Agreement State; Ability to provide reagent kit(s) that have been manufactured, labeled, packed and distributed in accordance with the approval by the commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use; Ability to have available an adequate supply of contract products to meet the requirements of system at his/distribution points and; Ability for contractor to label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date, etc. and provide a bar labeled insert to allow scanning data into a nuclear medicine information management system. RELEVANT EXPERIENCE/PAST PERFORMANCE The Relevant Experience/Past Performance evaluation will assess the relative risks associated with an offeror s likelihood of success in performing the solicitation s requirements as indicated by that offeror s record of Relevant Experience/Past Performance. Offerors that have provided the service for other VA facilities in the past must provide a list with their offeror s that provides sates of services provided, facility and government point of contact name, telephone number and email address and; Offerors must provide at least two (2) references of other similar facilities where the exact service of performing Radiopharmaceutical services was provided within the last two years (use Past Performance Information Survey form provided within this solicitation) and have references returned to the contracting activity. Attachment A to the Statement of Work Schedule of Deliverables Deliverable No. One Item Provide any training or education required to meet commercial standards related to use of radiopharmaceuticals Quantity 1 Delivery Date Within _20__ calendar days after award Two etc. Nuclear Medicine management program (Hardware and Software) 3 EA Within _5__ calendar days after award POTENTIAL SOURCES SHALL PROVIDE THE FOLLOWING INFORMATION IN THEIR RESPONSE: 1) Company name, address, phone number, primary contact(s), e-mail address, NAICS code(s), business size (i.e., small/large) and DUNS Number. 2) Provide a Statement of Capability that demonstrates the offeror's past performance in providing Special Needs Transportation Services. Please include the following: (a) staff expertise including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3) Submit Capability Statements and other applicable information as referenced above by September 7, 2018 to Gail Bargaineer via email: gail.bargaineere2@va.gov. Responses should be received no later than 1:00 PM EST. NO CAPABILITY STATEMENTS MAY BE SUBMITTED AFTER September 7, 2018. AT THIS TIME NO SOLICITATION EXISTS. (DO NOT REQUEST A COPY OF THE SOLICITATION). A FUTURE NOTICE WILL BE POSTED WHEN THE SOLICITATION WILL BE RELEASED. 4) Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities (FBO). However, responses to this notice will not be considered adequate responses to a solicitation. (5) No Proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s.)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/AtlVAMC/VAMCCO80220/36C24718Q9535/listing.html)
- Document(s)
- Attachment
- File Name: 36C24718Q9535 36C24718Q9535.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4577876&FileName=36C24718Q9535-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4577876&FileName=36C24718Q9535-000.docx
- File Name: 36C24718Q9535 FBO-DESCRIPTION.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4577877&FileName=36C24718Q9535-001.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4577877&FileName=36C24718Q9535-001.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: 36C24718Q9535 36C24718Q9535.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4577876&FileName=36C24718Q9535-000.docx)
- Record
- SN05073195-W 20180907/180905231135-f692b85ffd7fac62e48399ca2ab5b2b2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |