SOLICITATION NOTICE
65 -- Nuclear Medicine Radiopharmaceuticals
- Notice Date
- 5/17/2023 1:26:10 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- 249-NETWORK CONTRACT OFFICE 9 (36C249) MURFREESBORO TN 37129 USA
- ZIP Code
- 37129
- Solicitation Number
- 36C24923Q0322
- Response Due
- 5/24/2023 8:00:00 AM
- Archive Date
- 08/31/2023
- Point of Contact
- Christina Lawrence, Contract Specialist, Phone: 615-225-3426
- E-Mail Address
-
Christina.Lawrence2@va.gov
(Christina.Lawrence2@va.gov)
- Awardee
- null
- Description
- Page 1 of Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-02. This solicitation is unrestricted full and open competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412 with a small business size standard of 1,300 Employees. The FSC/PSC is 6505. The Memphis VAMC is seeking to purchase below items. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 1-123 Loflupane Unit dose (Curium Generic Datscan) Product# 108640 20 EA STATEMENT OF WORK SCOPE/DELIVERY: Provide radiopharmaceutical Loflupane I-123 Generic Datscan All orders will be agreed upon between the offeror and the Department of Veterans Affairs prior to shipment. Provide Non-HEU products when available. No delivery charge shall be made for additional deliveries during normal working hours, 6:30a.m. -4:30p.m. Offeror will provide the VAMC - Memphis with four scheduled deliveries per day at no charge. The contractor must be able to provide emergent radiopharmaceuticals within an hour. The contractor must be able to provide bar coding compatible to the Biodose system so we can accurately track incoming radioactive material. Emergency and priority studies consist of 20% -30% of the daily schedule. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable. Any substitutions of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee. All defective or inferior products shall be replaced within 2 hours at no costs to the VA. It is the Contractor s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer via the most expedient method. The first daily delivery shall be made to Nuclear Medicine (Room G111) by 6:30 a.m. unless prior authorization arrangements have been made. Subsequent deliveries will likewise be made as described above as needed. Weekend (Saturday/Sunday) and all Federal Holiday (or any other day specifically declared by the President of the United States to be a national holiday) deliveries shall be made by contacting the Veterans Medical Center Police to unlock the Nuclear Medicine Department (Room G 111) for placement of the packages. All unit dose radiopharmaceuticals delivered must have a bar code with it so the dose can be scanned into the department s dose tracking system that it owns. All radiopharmaceuticals shall be delivered in unit dose form in lead-shielded containers. Plastic shrink wrap fitted at union of container cap and base to ensure proper seal. Federal Holidays: New Year s Day Martin Luther King s Birthday President s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day PERFORMANCE/QUALITY: Contractor shall provide evidence of special driver s licenses (competency) due to transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State). Contractor shall test all products for Quality Control periodically and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. All products are purchased subject to acceptance by the VA, Nuclear Medicine Service. Products that fail to meet Quality Control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicine s Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials. All products shall be tested for Quality Control by the supplier and only those products that pass Quality Control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VA Nuclear Medicine Service. Contractor shall pick up scheduled items, used and unused, for proper disposal. The contractor will provide a quarterly linearity source at no charge. The activity requested can range from 25 to 300 mCi. Contractor will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Contractor shall provide leukocyte and platelet labeling services, including weekends. If the volume warrants, leukocyte and platelet labeling will be available as a same day service. All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration, time, total volume, total activity, lot number and prescription number. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated. Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided at no additional charge. The VA Staff of Nuclear Medicine Technologists who will be authorized to place telephone orders will be provided under the resultant contract. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: a Licensee may use for medical use only: By-product material 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 kits that have been manufactured, labeled, packed and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Contractor shall meet all Nuclear Regulatory Commission (NRC), Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State). Contractor must be NRC certified. ADVISORY CONSULTATION AND INVOICING: Contractor shall be paid monthly, in arrears, upon submission monthly of a properly prepared invoice for services/supplies during the period. Said invoices will be reviewed by the Contracting Officer s Technical Representative (COTR) for accuracy and any discrepancies corrected and a new invoice issued before payment is issued. All invoices will include the contract number, date of services, name of patient, and an itemized listing of charges. Nuclear Medicine shall be provided with copies of invoices. Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements shall be received within 2 hours of notification by the VA. Consultation service regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge. SPECIAL CONTRACT REQUIREMENTS The contractor will be required to attend a Post Award Orientation Conference prior to start of work. The purpose of the conference is to aid both Government and contractor personnel to (1) achieve a clear and mutual understanding of all contract requirements, and (2) identify and resolve potential problems. It is not a substitute for the contractor's fully understanding the work requirements at the time offers are submitted, nor is it to be used to alter the final agreement arrived at in any negotiations leading to contract award. The date, time, and location of the conference shall be schedule by the Contracting Officer. The conference may be conducted via teleconference if deemed appropriate. QUALIFICATIONS: Personnel assigned by the contractor to perform the services covered by this contract shall be 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 VA Chief of Staff and approval by VA Facility Director. PERSONNEL POLICY: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel. Worker's compensation Professional liability insurance Health examinations: Income tax withholding, and Social Security payments. The parties that such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor. All radiopharmaceutical items on contract will be shipped Contractor will be on-site for drop off deliveries. Incidental exposure to PHI is possible, but not required for contractor to perform duties. Place of Performance/Place of Delivery Memphis VAMC Address: 1030 Jefferson Ave, Memphis, TN 3 Postal Code: 38104 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services March 2023 FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services December 2022 Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services December 2022 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services March 2023 All quoters shall submit the below items. Non-compliance to the below items with this requirement may result in disqualification of the quote. Only one quote. Quote shall be on offeror s company letterhead, in PDF format and emailed to Christina.lawrence2@va.gov NLT 05/24/2023 at 10:00 AM CT. The solicitation number, 36C24923Q0322 must be referenced in the subject line. Product information brochure with specifications and user manual shall accompany quote. Offeror must submit certification that equipment meets the salient characteristics of listed above. Quote must reflect the Statement of Work in this solicitation. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following are the decision factors: Technical or Quality Delivery (After receipt of Order) Price The award will be made to the response most advantageous to the Government. Responses should contain your best terms and conditions. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. A.1 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/ FAR Number Title Date 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS MAR 2023 852.203-70 COMMERCIAL ADVERTISING MAY 2018 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR VERIFIED SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES NOV 2022 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING--CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS NOV 2022 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS NOV 2018 852.246-71 REJECTED GOODS OCT 2018 (End of Addendum to 52.212-4) A.2 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAR 2023) (a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition (1) Is set aside for small business and has a value above the simplified acquisition threshold; (2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or (3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value. (b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show (1) The solicitation number; (2) The time specified in the solicitation for receipt of offers; (3) The name, address, and telephone number of the offeror; (4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary; (5) Terms of any express warranty; (6) Price and any discount terms; (7) ""Remit to"" address, if different than mailing address; (8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically); (9) Acknowledgment of Solicitation Amendments; (10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and (11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration. (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation. (d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing. (e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately. (f) Late submissions, modifications, revisions, and withdrawals of offers. (1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due. (2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is ""late"" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and (A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or (B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or (C) If this solicitation is a request for proposals, it was the only proposal received. (ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted. (3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel. (4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. (5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers. Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer. (g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received. (h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer. (i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to GSA Federal Supply Service Specifications Section Suite 8100 470 East L'Enfant Plaza, SW Washington, DC 20407 Telephone (202) 619-8925 Facsimile (202) 619-8978. (ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee. (2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites: (i) ASSIST (https://assist.dla.mil/online/start/); (ii) Quick Search (http://quicksearch.dla.mil/); (3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by- (i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm); (ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or (iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462. (4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance. (j) Unique entity identifier. (Applies to all offers that exceed the micro-purchase threshold, and offers at or below the micro-purchase threshold if the solicitation requires the Contractor to be registered in the System for Award Management (SAM).) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation Unique Entity Identifier followed by the unique entity identifier that identifies the Offeror s name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier. (k) [Reserved] (l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable: (1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer. (2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror. (3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection. (4) A summary of the rationale for award; (5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful offeror. (6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency. (End of Provision) A.3 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) and http://www.va.gov/oal/library/vaar/index.asp (VAAR) (End of Provision) FAR Number Title Date 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING AUG 2020 52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST OCT 2020 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS OCT 2019 852.273-70 LATE OFFERS NOV 2021 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES DEC 2022 (End of Addendum to 52.212-1) A.4 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (b) The following factors shall be used to evaluate quotations: (1) Technical or Quality (2) Delivery (After receipt of Order) (3) Price Technical and past performance, when combined, are significantly more important than cost or price. (c) Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following: Technical or Quality: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation. Price: The Government will evaluate the price by adding the total of all line item prices. The Total Evaluated Price will be that sum. (End of Provision) Page 1 of 11 Page 1 of Point of Contact Any questions or concerns regarding this solicitation shall be sent in writing only via email addressed to Christina.Lawrence2@va.gov subject line: 36C24923Q0322. Questions shall be submitted NO LATER THAN 05/22/2023 @ 10:00 AM CT. Quote must be submitted NO LATER THAN 05/24/2023 @ 10:00 AM CT.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/9d20cab41b97490c8e3ed7f777088d92/view)
- Place of Performance
- Address: Memphis VAMC 1030 Jefferson Ave, Memphis 38104
- Zip Code: 38104
- Zip Code: 38104
- Record
- SN06685886-F 20230519/230517230109 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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