Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 28, 2013 FBO #4387
DOCUMENT

65 -- POSITRON EMISSION TOMOGRAPHY (PET) ISOTOPES - Attachment

Notice Date

11/26/2013
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

VISN 2 NCO (2-90);CONTRACTING OFFICER;DEPARTMENT OF VETERANS AFFAIRS;1304 BUCKLEY ROAD, SUITE C102;SYRACUSE, NY 13212
 

ZIP Code

13212
 

Solicitation Number

VA52814Q0048
 

Response Due

12/9/2013
 

Archive Date

2/7/2014
 

Point of Contact

Allison Dubin
 

E-Mail Address

25-4400
 

Small Business Set-Aside

Total Small Business
 

Description

This document is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, proposals are being requested, and a written solicitation will not be issued The proposed contract action is for supplies or services for which the Government intends to solicit competitive offers. Interested persons may submit offers, and all eligible offers received prior to the date listed in FBO will be considered by the Government. The NAICS code is 325412 and the size standard is 750 Employees. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-69. Only emailed requests received directly from the requester are acceptable. Period of Performance: Base Year: January 1, 2014 - December 31, 2014. Option Year 1: January 1, 2015 - December 31, 2015 Option Year 2: January 1, 2016 - December 31, 2016 Option Year 3: January 1, 2017 - December 31, 2017 A. PRICING Please submit a separate spreadsheet listing the quantity, unit price and extended amount for each radiopharmaceutical listed below for the base year and each option year. Offerors must provide pricing for normal and expedited orders for each radiopharmaceutical identified in the statement of work. Base Year: January 1, 2014 - December 31, 2014 Product nameUnit of MeasureEstimated Annual UsageUnit PriceTotal Price FDGUnit dose360 F18 or equivalentUnit dose120 Option Year 1: January 1, 2015 - December 31, 2015 Product nameUnit of MeasureEstimated Annual UsageUnit PriceTotal Price FDGUnit dose360 F18 or equivalentUnit dose120 Option Year 2: January 1, 2016 - December 31, 2016 Product nameUnit of MeasureEstimated Annual UsageUnit PriceTotal Price FDGUnit dose360 F18 or equivalentUnit dose120 Option Year 3: January 1, 2017 - December 31, 2017 Product nameUnit of MeasureEstimated Annual UsageUnit PriceTotal Price FDGUnit dose360 F18 or equivalentUnit dose120 B. INSTRUCTIONS TO OFFERORS As a minimum, offers must include- 1. Offerors must return provision 52.212-3 with their proposal. Offerors may either (1) complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed official representations and certifications online at https://www.sam.gov. 2. Contact information, Name, Phone Number, Fax Number and email address 3. Mailing address and Remit to address, if different than mailing address 4. Acknowledgment of Solicitation Amendments 5. Offeror's Federal Tax ID Number; 6. Offeror's DUNS number 7. Equipment Place of Manufacture (include US city, state and ZIP+4; or foreign country) 8. Offeror must provide copies of licenses and certifications C. SOLICITATION PROVISIONS/CONTRACT CLAUSES: FAR 52.212-1 Instructions to Offerors - Commercial Items (Jul 2013). FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (Aug 2013): Offerors must include a completed copy of the provision with its offer or fill out online representations and certifications at https://www.sam.gov FAR 52.212-4 Contract Terms and Conditions -- Commercial Items (July 2013). FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items (Aug 2013) For the purposes of this clause items (b) 1,4,6,7,14,23,26,27,28,29,30,31,32,33,38,39,41,42, and 48 are considered checked and apply. FAR 52.232-38 Submission of Electronic Funds Transfer Information with Offer (Jul 2013) FAR 52.252-1 - Solicitation Provisions Incorporated by Reference (Feb 1998); for the purpose of this provision, the fill-in's are http://farsite.hill.af.mil/farsites.html and http://farsite.hill.af.mil/vfvara.HTM respectively. FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998); for the purpose of this clause, the fill-in's are http://farsite.hill.af.mil/farsites.html and http://farsite.hill.af.mil/vfvara.HTM respectively. FAR 52.223-3 Hazardous Material Identification and Material Safety Data-Alternate I (Jan 1997) FAR 52.232-18 Availability of Funds (Apr 1984) VAAR 852.203-70 Commercial Advertising (Jan 2008) VAAR 852.211-70 Service Data Manuals (NOV 1984) (a) 811.107(a) VAAR 852.246-71 Inspection (Jan 2008) VAAR 852.232-72 Electronic Submission of Payment Requests (Nov 2012) D. STATEMENT OF WORK Stratton VA Medical center, Albany, NY is contracting for a centrally located Nuclear Pharmacy to provide both diagnostic and therapeutic unit dose radiopharmaceuticals. The Contractor shall supply the Imaging Service, Nuclear Medicine Section with the PET radiopharmaceuticals that are listed on the Department of Veterans Affairs Materials Permit No 31-02755-05, Amendment No 34 for Albany VAMC. A copy of the Materials License is attached at the end of this solicitation. The Contractor must be capable of supplying Nuclear Medicine with the required unit doses and cold kits approved for nuclear medicine use as needed by VA. The Contractor needs to accept daily orders and have them calibrated for the time it is requested by VA. The Contractor is responsible for delivering the material at least twice a day, the first drop off occurring at 7:30 am from orders placed the evening before. The second drop off will be scheduled as needed by the Nuclear Medicine technologists. The PET radiopharmaceuticals need to be contained in a syringe with the patient's name, identifier, description of what was ordered, and dosage amount in order to eliminate possible administration errors. The Contractor must include provision for return of and credit for cancelled doses. The contractor is also responsible for delivering the materials following the shipping protocol in accordance with the Nuclear Regulatory Commission requirements and the State of New York and Department of Transportation (DOT) rules and regulations. These standards include that the material being delivered must be inside a lead pig, locked in an appropriate external container. 1.No deliveries of unit doses except by the courier of the supplier. 2.All couriers must wear picture ID that is clearly visible while making deliveries of radiopharmaceuticals. All packaging of radioactive material must be clearly labeled RADIOACTIVE on the outside of the carton it is shipped in. All appropriate package signage will be observed according to DOT and NYS rules and regulations, as usual and customary. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State). Contractors shall perform all quality control procedures as required by Federal and State regulatory agencies. The contactor shall also provide for government use of software and equipment for the term of this agreement specifically for the monitoring and managing of the radiopharmaceutical products provided under this contract. The software and equipment will be used to maintain accurate radiation safety records for regulatory review, as well as to provide inventory tracking and waste management monitoring. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. a.Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. b.For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. E.TRAINING 1.All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems a.Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; b.Successfully complete the appropriate VA privacy training and annually complete required privacy training; and c.Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access. 2.The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. 3.Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. F.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. G.REPORTING REQUIREMENTS N/A H.TRAVEL N/A I.GOVERNMENT RESPONSIBILITIES The Nuclear Medicine Service of the Stratton VAMC shall ensure that: 1.The specification of the Product (radiopharmaceutical) is safe for the intended use 2.The products are handled in a safe manner, and 3.Any waste originating from the Products is disposed of in accordance with any relevant regulations. J.CONTRACTOR EXPERIENCE REQUIREMENTS N/A K.CONFIDENTIALITY AND NONDISCLOSURE N/A L.CONTRACTOR PERSONNEL SECURITY REQUIREMENTS The C&A requirements do not apply. A Security Accreditation Package is not required. RESPONSES ARE DUE Monday, December 9th, 2013, by 5:00 p.m. Eastern Daylight time. Use electronic mail to submit quotations with a scanned electronic signature to BOTH allison.dubin2@va.gov AND mary.betker@va.gov. Telephone inquiries will not be accepted, please submit questions regarding this solicitation via email to allison.dubin2@va.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/SyVAMC670/SyVAMC670/VA52814Q0048/listing.html)
 

Document(s)

Attachment
 

File Name: VA528-14-Q-0048 VA528-14-Q-0048.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1104642&FileName=VA528-14-Q-0048-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1104642&FileName=VA528-14-Q-0048-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03241707-W 20131128/131126234425-4346d9042e04f47e726699fb6f4f2b23 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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