Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 23, 2014 FBO #4443
DOCUMENT

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

Notice Date

1/21/2014
 

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
 

Solicitation Number

VA52814Q0099
 

Response Due

1/28/2014
 

Archive Date

3/29/2014
 

Point of Contact

Allison Dubin
 

E-Mail Address

25-4400
 

Small Business Set-Aside

Total Small Business
 

Description

The Albany VA Medical Center currently has a procurement request for radiopharmaceuticals. This 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. Interested parties that can respond to this Combined Synopsis/Solicitation must provide evidence that they have a potential to meet the requirements as identified herein. STATEMENT OF WORK (SOW) Stratton VA Medical Center, Albany, NY is contracting for a centrally located Nuclear Pharmacy to provide both diagnostic and therapeutic unit dose PET radiopharmaceuticals. SUPPLIES OR SERVICES Contractor to provide radiopharmaceuticals to be used in the GE Discovery PET/CT model number 432541CN1. A. UNIT DOSE ITEMS Period of Performance: February 15, 2014 - January 14, 2015 Product nameUnit of MeasureEstimated Annual UsageUnit PriceTotal Price FDGUnit dose360 F18 or equivalentUnit dose120 B. DESCRIPTION/SPECIFICATIONS Contractor shall furnish and deliver supplies as listed herein to the: Albany VAMC 113 Holland Avenue, Building 27 Albany, NY 12208 C. DELIVERY ORDERS 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. The Contractor must be capable of supplying Nuclear Medicine with the required unit doses and cold kits approved for nuclear medicine PET Scans 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. Inside delivery is required for deliveries. 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 PET 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. D. DELIVERY LOCATION Deliveries will be made to the PET Hot lab. Room number is unknown at this time. E. EMERGENCY ORDERING PROCEDURES N/A - there should be no need for emergent orders. F. PERSON'S AUTHORIZED TO PLACE ORDERS Kevin Lee & Sabrina Carter G. SOLICITATION Evaluation will be made based on lowest price technically acceptable. Resulting award will be a firm-fixed price IDIQ. Minimum guarantee will be met with first order placed. H. ABBREVIATIONS FDG:Fluorodeoxyglucose F18:Fludeoxyglucose I. NATIONAL HOLIDAYS Services shall be available Monday through Friday, during normal business hours. Services are not needed nights, weekends and Federal Holidays. Federal Holidays consist of: New Year's Day Martin Luther King's Birthday President's Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day J. INSTRUCTION TO OFFERORS Vendor must be registered with the sam.gov to further qualify for this contract. All those interested should submit, in writing, following information: Please submit a separate spreadsheet listing the quantity, unit price and extended amount for each radiopharmaceutical listed below for the period of performance. Offerors must provide pricing for normal and expedited orders for each PET radiopharmaceutical identified in the statement of work. Product nameUnit of MeasureEstimated Annual UsageUnit PriceTotal Price FDGUnit dose360 F18 or equivalentUnit dose120 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.Company name, phone number and fax number 3.Company point of contact name, email address and phone number 4.Company Mailing address and Remit to address, if different than mailing address 5.Acknowledgment of Solicitation Amendments 6.Offeror's Federal Tax ID Number; 7.Offeror's DUNS number 8.Business size Equipment Place of Manufacture (include US city, state and ZIP+4; or foreign country) 9.Offeror must provide copies of licenses and certifications 10.A detailed statement regarding technical capabilities and qualifications, and any additional supporting literature. K.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. L.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. M.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. All interested parties shall respond to allison.dubin2@va.gov by 5:00 PM EST January 28, 2014. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information can be emailed to the Contracting Specialist. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Under Statutory Authority 41 U.S.C. 253 (1) the Albany VA Medical Center anticipates entering into a procurement for radiopharmaceuticals. (ii) The reference/solicitation number is VA528-14-Q-0069 and the solicitation is issued as a request for quotation (RFQ). The combined synopsis/solicitation will result in a contract and corresponding purchase order. (iii) The provisions and clauses incorporated into this solicitation document are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) can be accessed on the Internet at https://www.acquisition.gov/far/ and http://www.va.gov/oamm/oa/ars/policyreg/vaar/, respectively. (iv) North American Industry Classification System (NAICS) code is 325412 (size standard of 750 employees) applies to this solicitation. (v) This requirement consists of radiopharmaceuticals (vi) Period of performance is February 15, 2014 - February 14, 2015 (vii) Delivery of radiopharmaceuticals will be to the Albany VAMC, 113 Holland Avenue, Building 27, Albany, NY 12208. (viii) The following solicitation provisions/contract clauses apply: FAR 52.212-1, Instructions to Offerors - Commercial Items (Jul 2013) FAR 52.212-3, Offeror Representations and Certification, Commercial Items (Aug 2013). Offerors must include a completed copy of the provision with its offer or fill out online representations and certifications at 52.212-1 Instructions to Offerors-Commercial Items. FAR 52-212-4, Contract Terms and Conditions - Commercial Items (Jul 2013). FAR 52.212-5, Contracts Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Aug 2013). For the purposes of this clauses, items (b), 1, 4, 6, 7 14, 23, 26, 27, 28, 29, 30, 31,32, 33, 38, 39, 41, 42, and 48 are considered checed and apply. FAR 52.216-22, Indefinite Quantity 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/ and http://farsite.hill.af.mil/vffara.htm respectively. FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). For the purpose of this provision, the fill-in's are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively. FAR 52.223-3, Hazardous Material Identification and Material Safety Data - Alternate I (Jan 1997). FAR 52.232-18, Availability of Funds 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) VAAR 852.216-70, Estimated quantities (Apr 1984) RESPONSES ARE DUE Tuesday, January 28, 2014, by 5:00 p.m. Eastern Daylight time. (xvii) Use electronic mail to submit quotations with a scanned electronic signature to allison.dubin2@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/VA52814Q0099/listing.html)
 

Document(s)

Attachment
 

File Name: VA528-14-Q-0099 VA528-14-Q-0099.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1168171&FileName=VA528-14-Q-0099-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1168171&FileName=VA528-14-Q-0099-000.docx

 

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

Record

SN03271395-W 20140123/140121234134-821ec47f92afa076f77dba0b6529724c (fbodaily.com)
 

Source

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

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