DOCUMENT
65 -- PET Radiopharmaceuticals - Attachment
- Notice Date
- 9/7/2018
- Notice Type
- Attachment
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office;NCO 19;6162 South Willow Drive, Suite 300;Greenwood Village CO 80111
- ZIP Code
- 80111
- Solicitation Number
- 36C25918Q9909
- Response Due
- 9/12/2018
- Archive Date
- 11/11/2018
- Point of Contact
- Matt Zorch
- E-Mail Address
-
paul.zorch@va.gov
(paul.zorch@va.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Request for Quote (RFQ) #: 36C25918Q9761_1 Positron Emission Tomography (PET)/Computed Tomography (CT) 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; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. * Quotes are to be provided to Matt Zorch at paul.zorch@va.gov no later than 4:00pm EST, September 12, 2018. This is a Request for Quote (RFQ) and the solicitation number is 36C25918Q9761_1. The government anticipates awarding a firm-fixed price contract resulting from this solicitation. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-100 effective August 22, 2018. The North American Industrial Classification System (NAICS) code for this procurement is 325412 with a small business size standard of 1,250 employees. This solicitation is a 100% set-aside for Small Business concerns. List of Line Items; The Department of Veterans Medical Center Oklahoma City Nuclear Medicine PET Service requires the Contractor to provide radiopharmaceutical and any needed sources to be used with GE Discovery 690 PET/CT Scanner. Items will be in unit dose or bulk delivery, daily, and on an as needed basis, in accordance with patient requirements for the period of one Base Year with four Option Years that may be exercised at the VA s discretion. Note: All annual quantities are estimates, contractor will only be paid for items and quantities actually ordered and delivered. BASE YEAR: OCTOBER 1, 2018 SEPTEMBER 30, 2019 Line Item Description Annual Qty (est.) Unit Unit Price Extended Price (est.) 0001 Normal/Routine Ordering & Delivery (F18FDG @ 8-15 mCi per dose) 1230 Dose or bulk vial 0002 Normal/Routine Ordering & Delivery (F18NaF @ 8-15 mCi per dose) 10 Dose or vial 0003 Tungsten Pigs/Shields w/ Shipping containers 2 EA Supplied by vendor N/C $0.00 0004 Quality Control Dose (camera) 30 mCi 4 Dose or vial 0005 Quality Control Dose (Intego) 35 mCi 4 Dose or vial TOTAL BASE YEAR: OPTION YEAR 1: OCTOBER 1, 2019 SEPTEMBER 30, 2020 Line Item Description Annual Qty (est.) Unit Unit Price Extended Price (est.) 1001 Normal/Routine Ordering & Delivery (F18FDG @ 8-15 mCi per dose) 1235 Dose or bulk vial 1002 Normal/Routine Ordering & Delivery (F18NaF @ 8-15 mCi per dose) 20 Dose or vial 1003 Tungsten Pigs/Shields w/ Shipping containers 2 EA Supplied by vendor N/C $0.00 1004 Quality Control Dose (camera) 30 mCi 4 Dose or vial 1005 Quality Control Dose (Intego) 35 mCi 4 Dose or vial TOTAL OPTION YEAR 1: OPTION YEAR 2: OCTOBER 1, 2020 SEPTEMBER 30, 2021 Line Item Description Annual Qty (est.) Unit Unit Price Extended Price (est.) 2001 Normal/Routine Ordering & Delivery (F18FDG @ 8-15 mCi per dose) 1240 Dose or bulk vial 2002 Normal/Routine Ordering & Delivery (F18NaF @ 8-15 mCi per dose) 20 Dose or vial 2003 Tungsten Pigs/Shields w/ Shipping containers 2 EA Supplied by vendor N/C $0.00 2004 Quality Control Dose (camera) 30 mCi 4 Dose or vial 2005 Quality Control Dose (Intego) 35 mCi 4 Dose or vial TOTAL OPTION YEAR 2: OPTION YEAR 3: OCTOBER 1, 2021 SEPTEMBER 30, 2022 Line Item Description Annual Qty (est.) Unit Unit Price Extended Price (est.) 3001 Normal/Routine Ordering & Delivery (F18FDG @ 8-15 mCi per dose) 1245 Dose or bulk vial 3002 Normal/Routine Ordering & Delivery (F18NaF @ 8-15 mCi per dose) 20 Dose or vial 3003 Tungsten Pigs/Shields w/ Shipping containers 2 EA Supplied by vendor N/C $0.00 3004 Quality Control Dose (camera) 30 mCi 4 Dose or vial 3005 Quality Control Dose (Intego) 35 mCi 4 Dose or vial TOTAL OPTION YEAR 3: OPTION YEAR 4: OCTOBER 1, 2022 SEPTEMBER 30, 2023 Line Item Description Annual Qty (est.) Unit Unit Price Extended Price (est.) 4001 Normal/Routine Ordering & Delivery (F18FDG @ 8-15 mCi per dose) 1250 Dose or bulk vial 4002 Normal/Routine Ordering & Delivery (F18NaF @ 8-15 mCi per dose) 20 Dose or vial 4003 Tungsten Pigs/Shields w/ Shipping containers 2 EA Supplied by vendor N/C $0.00 4004 Quality Control Dose (camera) 30 mCi 4 Dose or vial 4005 Quality Control Dose (Intego) 35 mCi 4 Dose or vial TOTAL OPTION YEAR 4: Description of Requirements for the items to be acquired (salient characteristics); The radiopharmaceutical requirement is for the radiopharmaceuticals F18 FDG and F18 NaF, as well as any other necessary sources and ancillary supplies needed for the GE Discovery 690 PET/CT scanner. Contractor must be licensed by the Nuclear Regulatory Commission or an Agreement State under equivalent regulations and be regularly established in the business of providing radiopharmaceuticals. Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only: 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. Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Contractor will deliver radioisotope in amount equal to or greater than the activity ordered with calibration for the specified appointment time. Contractor shall have available an adequate supply of contract products to meet the requirements of the Oklahoma City Department of Veterans Affairs Medical Center with proof of contingency supply chain (where such contingency supply chain exists) to prevent disruption of clinical care. Contractor shall be able to supply delivered PET radiopharmaceuticals as unit doses or in container compatible with MEDRAD Intego Pet Delivery System. Contractor is responsible for supplying container(s) compatible with MEDRAD Intego system. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Contractor shall meet all Nuclear Regulatory Commission, National Health Physics Program (NHPP), Department of Transportation, FDA, OSHA, and all other agency rules and regulations (Federal and State), as well as any applicable Joint Commission Requirements. PET Radiopharmaceutical Returns for Credit: The Contractor shall be responsible to accept returns for full credit toward future orders. Particularly under the following conditions: a. Product(s) ordered or shipped in error. b. Product(s) damaged in shipment c. Concealed shipping damages d. Recalled product(s) e. Outdated products in unopened, original container. Note: OKC-VAMC can return at least 5% of radioisotope due to patient cancellation or no show at no cost to the facility. Normal/ Routine PET Radiopharmaceutical Ordering and Deliveries: Orders shall be placed by authorized VA personnel during the normal workday, and first delivery shall be received no earlier than 06:30 am the following workday to the Oklahoma City VAMC Nuclear Medicine Service PET Department (1G-114) After award, the Contractor will be furnished the name(s) of VA personnel that are authorized to place orders against the Contract. Orders shall only be placed by authorized VA OKC Nuclear Medicine personnel via telephone, fax, e-mail or on-line. Depending upon Medical Center patient care requirements, the contractor shall provide routine delivery and pick-up, as many times as required by the OKC VAMC. Contractor agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. On-time Delivery Contractor is responsible for on time delivery of radiopharmaceutical and will have back-up facilities/production options available (where such contingency supply chain exists). All cancelled PET/CT scans due to contractor delayed delivery will be the responsibility of the contractor and the returned dose will not count towards the allotted 5% of available returns due to patient no show or cancellation. The Contractor will be furnished with a copy of the user s license information as per Nuclear Regulatory Commission guidelines. Same-Day Delivery Contractor will be available for Emergency orders in accordance with the schedule of supplies. Same-Day Delivery is required to be delivered and received at the OKC VAMC Nuclear Medicine PET/CT Service no later than 4 hours after order is placed during normal business hours. Nuclear Medicine PET/CT normal business hours are considered Monday through Friday: 7:00 am 4:30 pm, except Federal Holidays. The following are Federal Holidays: New Year s Day Birthday of Martin Luther King, Jr.(day of observance) Washington s Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.) Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the Schedule of Supplies and Services Section. POC Name: Address: City/State/Zip Code: Ordering Phone Number: Ordering Fax Number: Ordering E-Mail Address: DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone /fax orders/ on-line order shall become mandatory upon the Contractor's acceptance to commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by the Ordering Personnel. DELIVERY LOCATION: Deliveries will be made to: OKC VA Medical Center Attn: PET Center -1G-114 921 NE 13th St OKC, OK 73104 Contract/Delivery personnel shall be escorted within the Radiation Oncology center to the PET/CT Hot lab by Nuclear Medicine personnel. The C&A requirements do not apply, and that a Security Accreditation Package is not required Upon request by the COR, the Contractor shall provide miscellaneous supplies and/or services including, but not limited to the following: A copy of reports of contractor s RSO Safety Audits of Federal compliance. Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the Veterans Affairs Medical Center, located at OKC VA Medical Center Attn: PET Center - 1G-114 921 NE 13th Street Oklahoma City, OK 73104 52.212-1, Instructions to Offerors--Commercial ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Contractor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. Descriptive literature must be provided IAW FAR 52.214-21 for item(s) which are considered to be equal to or better than the requirements listed. Any award made as a result of this solicitation will be made on an All or Nothing Basis. State if quoted items are available and priced through contractors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract. Contractors socioeconomic status must be verified in the VA Vendor Information Pages (VIP): https://www.vip.vetbiz.gov/. Unverified contractors will be considered non-responsive. Contractors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the contractor making such contact may be excluded from award considerations. All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. All information shall be confined to the appropriate file. The contractor shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Contractors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. Any award made resulting from this solicitation will be made based on the best overall quote that is determined to be the best overall value to the Government, considering (I) Technical Capability and (II) price. Respondents to this announcement shall submit their quote on Contractors Letterhead in accordance with FAR 52.212-1. Submission of quote shall include the following volumes: (I) Technical Capability (II) Price. Volume I - Technical Capability Under no circumstances shall any pricing be included in the Technical Capability. The contractor shall submit a Technical Capability narrative which shall address in detail how the offeror proposes to accomplish each requirement with all documents necessary to validate the technical requirements are met (or exceeded). Responding companies shall include any relevant information (specifications, cut sheets, brochures, capability statement, etc.) confirming their ability to supply the products and services outlined in this request. Contractors shall submit copies of all licenses and certifications identified in the Statement of Work. Volume II Price Complete the Price Schedule of Supplies/Services of this solicitation, with proposed contract line item prices inserted in appropriate spaces and detail/itemize the pricing or add additional line items, if applicable. For services quoted, include labor categories, labor rates, and number of hours by task. The Government requires contractors to quote unit prices and total prices that are two (2) decimal places. The unit price multiplied by unit quantity must equal the total price for that line item. Contractors that do not adhere to the above instructions will be eliminated from consideration. (End of Addendum to 52.212-1) 52.212-2, Evaluation--Commercial Items ADDENDUM to FAR 52.212-2 EVALUATION COMMERCIAL ITEMS: (Edit as Appropriate) Any award resulting from this solicitation will be made based on the best overall quote that is determined to be the overall best value to the government. Pursuant to FAR 52.212-2, the criteria for evaluation is: (1) Technical Capability, (2) Price and (3) Past Performance. Technical Capability The Government will evaluate quotes on the basis of whether or not the provided quote meets the technical capability specified in the Statement of Work. Technical Capability shall consist of meeting or exceeding the requirements in the Statement of Work. Vendors shall include a management approach in the Technical Capability submission that demonstrate the capability to meet the ordering requirements for all calibration times. This includes 95% uptime with proof of contingency plan for doses (where contingency supply chain exists). The Technical Capability submission shall include detailed experience that demonstrates the ability to meet the requirements as defined in the Statement of Work. Price The Government will evaluate offers by adding all line item prices - the Total of All CLINS will be that sum. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet or exceed the technical capability requirements of the statement of work shall not be selected regardless of price. Options (if requested); The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s) Past Performance Vendors shall provide three references for the delivery of PET radiopharmaceuticals to the Federal Government within the past 5 years. All quotes shall be subject to evaluation by Government personnel. The Government intends to award without discussions based upon the initial evaluation of quotes. Consequently, contractors are highly encouraged to quote their best non-price and pricing quotes in their initial submissions. However, the Government reserves the right to communicate with any or all contractors submitting a quote, if it is determined advantageous to the Government to do so. If these communications take place, the Government is not obligated to communicate with every contractor (note that FAR Part 15 procedures do not apply; therefore, formal discussions are not applicable). All contractors will be treated fairly and impartially. A contractor may be eliminated from consideration without further communication if its non-price and/or pricing quotes are not among those contractors considered most advantageous to the Government based on a best value determination. All Offerors are advised that, in the interest of efficiency, the Government reserves the right to conduct the review in the most effective manner. Specifically, the Government may first sort the quotes of all Offerors by price from lowest price to the highest. Thereafter, the Government will review the Technical Capability of the lowest priced quote only. If the lowest priced Offeror s Technical Capability is determined to be acceptable and meets the requirements, the Government may make award to that Offeror without further reviews of the remaining Offerors Technical Capability. If the lowest priced Offeror s Technical Capability is determined to not meet the requirement, then the Government may review the Technical Capability next lowest priced quote, and so forth and so on, until the Government reaches a quote that is determined to meet the Technical Capability requirements. Quotes that merely restate the requirement or state that the requirement shall be met, without providing supporting rationale, are not sufficient. Contractors are cautioned that the award may not necessarily be made to the contractor quoting the lowest price, or to the contractor with the most highly technical quote. Award may be made to other than the lowest priced quote, if the Government determines that a price premium is warranted due to the merits of one or more of the non-price factors. (End of Addendum to 52.212-2) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with the offer. 52.212-4, Contract Terms and Conditions--Commercial Items applies to this acquisition 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference; FAR 52.203-6 Restrictions on Subcontractor Sales to the Government (SEPT 2006), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402) FAR 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note) FAR 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015) (31 U.S.C. 6101 note) FAR 52.219-8 Utilization of Small Business Concerns (NOV 2016) (15 U.S.C. 637(d)(2) and (3)); FAR 52.219-28 Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)) FAR 52.222-3 Convict Labor (June 2003) (E.O. 11755) FAR 52.222-19 Child Labor Cooperation with Authorities and Remedies (OCT 2016) (E.O. 13126) FAR 52.222-21 Prohibition of Segregated Facilities (APR 2015) FAR 52.222-26 Equal Opportunity (SEP 2016) (E.O. 11246) FAR 52.222-35 Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212) FAR 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793) FAR 52.222-37 Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212) FAR 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496) FAR 52.222-50 Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627) FAR 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) FAR 52.225 5 Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note) FAR 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) FAR 52.232-33 Payment by Electronic Funds Transfer System of Award Management (Jul. 2013) Additional contract requirements or terms and conditions: 52.232-18 Availability of Funds (Apr 1984) Funds are not presently available for this contract. The Government s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer. (End of clause) 52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ The following FAR clauses are incorporated by reference: 52.204-7 System for Award Management The following VAAR clauses are to be incorporated by reference: 852.203-70 Commercial Advertising (JAN 2008); 852.232-72 Electronic Submission of Payment Requests (NOV 2012); 852.246-70 Guarantee (JAN 2008); 852.246-71 Inspection (JAN 2008) 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR) The following FAR provisions are to be incorporated by reference: The following VAAR provisions are to be incorporated by reference: 852.273-70 Late Offers (JAN 2003); 852.273-72 Alternate Evaluation (JAN 2003); and 852.273-74 Award Without Exchanges (JAN 2003). The Defense Priorities and Allocations System (DPAS) does not apply. Date and Time offers are due to Matt Zorch at paul.zorch@va.gov by 4:00pm EST, September 12, 2018. Name and email of the individual to contact for information regarding the solicitation: Matt Zorch Paul.Zorch@va.gov
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- File Name: 36C25918Q9909 36C25918Q9909.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4581517&FileName=36C25918Q9909-000.docx)
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- File Name: 36C25918Q9909 Schedule of Supplies.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4581518&FileName=36C25918Q9909-001.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4581518&FileName=36C25918Q9909-001.docx
- File Name: 36C25918Q9909 Statement of Work - 28AUG2018.pdf (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4581519&FileName=36C25918Q9909-002.pdf)
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- File Name: 36C25918Q9909 36C25918Q9909.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4581517&FileName=36C25918Q9909-000.docx)
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