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SAMDAILY.US - ISSUE OF FEBRUARY 16, 2023 SAM #7751
SOLICITATION NOTICE

65 -- WLR New Radiopharmaceutical Contract (VA-23-00029869)

Notice Date

2/14/2023 9:37:16 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

252-NETWORK CONTRACT OFFICE 12 (36C252) MILWAUKEE WI 53214 USA
 

ZIP Code

53214
 

Solicitation Number

36C25223Q0343
 

Response Due

2/24/2023 12:00:00 PM
 

Archive Date

03/11/2023
 

Point of Contact

Steven MacDonald, Contract Specialist, Phone: 414-844-4882
 

E-Mail Address

steven.macdonald@va.gov
(steven.macdonald@va.gov)
 

Awardee

null
 

Description

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, 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 2023-01. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The FSC/PSC is 6505, Drugs and Biologicals. VA anticipates a Single Award, Firm-Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) with a Three (3) Year Ordering Period Contract based on the contents of this solicitation. The contractor shall propose a fixed amount for each Radiopharmaceutical listed as well as provide their part numbers for all Radiopharmaceuticals listed. All interested companies shall provide quotations for the following: Performance Work Statement DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Contactor must provide up to five daily routine deliveries and/or pick-ups at no charge to the VA.   Being full unit dose now the most routine deliveries we would have is 5.  It also saves the VA money by not paying delivery fees.  Most of the time there are three deliveries being made on a daily basis. Contactor must provide up to five daily routine deliveries and/or pick-ups at no charge to the VA. Routine daytime (Monday Friday not including holidays) deliveries: 5:30 am 4:00 pm. The vendor will deliver to Bldg. 111, room 10528. The contractor s radio pharmacist must be available on site at the contractor s facility to take orders up to 4:00 pm unless otherwise agreed to by the VA Representative. For doses and non-radioactive items ordered prior to day of calibration, delivery should be a minimum of one hour prior to calibration time or stated time of use. The VA technologist may request that a delivery be as soon as possible. If this would result in delivery of less than one hour from the time of the order, this does not imply a request for stat delivery and will not result in stat charges by the contractor. Stat off hours deliveries: Weekdays 4:00 pm 5:30 am, weekends midnight to midnight and all Federal and National holidays midnight to midnight. The vendor will be escorted by the VA Police and deliver to Bldg. 111, room 10516. The contractor shall provide a process for direct phone contact to the contractor s radiopharmacist. Contractor shall replace any items delivered in error at no cost to the VA. Contractor shall label all products delivered as to the Unit and activity of radiopharmaceutical, time of preparation, expiration time and date, and name of person(s) drawing the unit dose. Vendor shall be in compliance with USP 797 guidelines. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., and all other agency rules and regulations (Federal and State). Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. Contractor shall provide the VA, when requested all specification testing on each package. Before contract award, Contractor shall provide a copy of their laboratory s current quality control manual to the Contracting Officers Technical Representative. Contractor shall test all products for Quality Control this testing shall be performed at no cost to the VA. The contractor shall provide a detailed description of the test upon request. Contractor shall assign an individual sales representative to aide in facilitation in the smooth coordination between the medical center and Contractor s laboratory pharmacy. Contractor shall pick up Radiopharmaceuticals for proper disposal at no cost to the Government. The Contractor must provide an OSHA compliant, puncture resistant, leak proof disposal container to safely transport used and unused doses back to the radio pharmacy for disposal. Contractor shall replace, after written notice from the Nuclear Medicine Technologist any expired cold kits 10 days prior to its expiration date at no charge to the VA. Contractor shall provide current material safety data sheets and updates on all delivered products upon request by the VA. Contractor shall provide patient orientation education video presentations and other appropriate material at no cost to the VA. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements must be received as soon as possible after notification by the VA. Contractor shall be licensed by the State of Wisconsin. Additionally, contractor shall be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radionuclides. Offeror must provide copies of these licenses and certifications to the Contracting Officer prior to award. The Contractor shall provide the option to order, review, and revise unit doses via the internet. Vendor shall provide certain critical radiopharmaceuticals with the follow lead times for routine weekday delivery: I-131 capsules for therapy: Same day delivery. The VA will alert vendor of estimated quantity as soon as procedure is known but will not order dose until exact dose has been determined, generally the day of procedure. Requirements specific to labeled white blood cells: Vendor shall provide labeling services for WBC doses for dates requested. This would include doses requested for near future dates and for same day. Vendor shall maintain sufficient inventory of In111 Oxine to allow for same day labeling requests. Vendor shall provide process and transport container for the transport of VA provided In111 Oxine from the VA to the vendor s radiopharmacy. The transport container shall meet or exceed all criteria for the shipment of limited quantities of radioactive materials as defined by the Nuclear Regulatory Commission (NRC). Vendor shall provide spare blood draw kits to be maintained on site at VA Milwaukee to accommodate the case where the patient s blood needs to be drawn urgently to initiate exam. In the absence of spare blood draw kits, the vendor shall develop a process where VA Milwaukee collects blood sample and then transfers to vendor s blood transport system at the time of blood sample pick up. Table 1. Contract Line Items Item # Description/Part Number* Estimated Yearly QTY Unit 1 Tc99m DTPA for multiple indications (1 - 20 mCi) 4 UD 2 Tc99m DTPA for multiple indications (20 - 40 mCi) 75 UD 3 Tc99m ECD (aka Neurolite) (30 mCi) 1 UD 4 Tc99m HMPAO (aka Ceretec) (30 mCi) 1 UD 5 Tc99m MAA Standard Particles (5 mCi) 60 UD 6 Tc99m MAA Reduced Particles (5 mCi) 10 UD 7 Tc99m MAG3 (10 mCi) 25 UD 8 Tc99m MDP (25 mCi) 250 UD 9 Tc99m Mebrofenin or similar (5 mCi) 35 UD 10 Tc99m PYP for Cardiac (25 mCi) 25 UD 11 Tc99m PYP for Aerosol (50 mCi) 1 UD 12 Tc99m Sestamibi for Cardiac (8 - 12 mCi rest; 24 - 35 mCi stress) 2 UD 13 Tc99m Sestamibi for Parathyroid (30 mCi) 15 UD 14 Tc99m NaTcO4 (1 - 30 mCi) 15 UD 15 Tc99m NaTcO4 (30 mCi or more) 1000 mCi 16 Tc99m Sulfur Colloid for Gastric empty (2 mCi) 50 UD 17 Tc99m Sulfur Colloid for Liver (6 mCi) 2 UD 18 Tc99m Sulfur Colloid Ultra filtered for Lymphoscintigraphy (200 uCi to 1 mCi) 4 UD 19 Tc99m Tetrofosmin for Cardiac (8 - 12 mCi rest; 24 - 35 mCi stress) 3050 UD 20 Gallium 67 Citrate 20 mCi 21 I-123 Capsules (100 uCi) 75 Capsules 22 I-123 Capsules (200 uCI) 1 Capsules 23 I-123 Capsules (2 - 10 mCi) 1 mCi 24 I-131 Capsules (Thereputic ) (Part of therapeutic dose) (1 - 6 mCi) 6 mCi 25 I-131 Capsules (Therapeutic) (Part of therapeutic dose) (7 or more mCi) 300 mCi 26 I-131 Capsules (Diagnostic) (1 - 6 mCi) 10 UD 27 In-111 DTPA 1 VIAL 28 Tl- 201 Chloride 15 mCi 29 Xe-133 gas (20 mCi) 2 UD 30 Tc99m Ceretec labeled leukocytes, including Ceretec (4 - 6 mCi) 1 UD 31 Labeled leukocyte compounding fee only (VA provides In111 Oxine) 1 EA 32 In-111 labeled leukocyte (VA does not provide In-111 Oxine) (500 uCi) 55 UD 33 DTPA Vial 1 VIAL 34 MAA Vial 1 VIAL 35 MDP Vial 1 VIAL 36 Mebrofenin or similar Vial 1 VIAL 37 Pyrophosphate Vial 1 VIAL 38 Ultra Tag Kit 10 Kit 39 Deliveries during normal business hours 5 Day 40 Emergency After-Hours Delivery 15 EA 41 Pharmacist After-Hour Emergency Call-Back 15 EA 42 Weekend White Blood Cell Labeling charge 1 EA Clauses and Provisions 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 (NOV 2021) FAR 52.204-7, System for Award Management (OCT 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (AUG 2020) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) FAR 52.233-2, Service of Protest (SEPT 2006) Address: 115 S 84th St, Ste 101 Milwaukee, WI 53214 End of Addendum to 52.212-1 FAR 52.212-2, Evaluation-Simplified Acquisition Procedures FAR 52.212-3, Offerors Representations and Certifications Commercial Items 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 Items. 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 Items (OCT 2018) Addendum to FAR 52.212-4 FAR 52.203-6, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (JUN 2020) FAR 52.204-4, Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011) FAR 52.204-13, System for Award Management Maintenance (OCT 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.217-8, Option to Extend Services (NOV 1999) FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000) Options may be exercised immediately at the discretion of the Government. FAR 52.222-49, Service Contract Labor Standards Place of Performance Unknown (MAY 2014) FAR 52.227-19, Commercial Computer Software-Restricted Rights (DEC 2007) FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (NOV 2021) (DEVIATION AUG 2020) VAAR 852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020) The following clauses from VAAR 852.212-70 apply to this acquisition. VAAR 852.203-70, Commercial Advertising VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors VAAR 852.215-71, Evaluation Factor Commitments VAAR 852.232-72, Electronic Submission of Payment Requests VAAR 852.233-70, Protest Content/Alternative Dispute Resolution VAAR 852.233-71, Alternate Protest Procedure VAAR 852.270-1, Representatives of Contracting Officers VAAR 852.237-74, Nondiscrimination in Service Delivery VAAR 852.242-71, Administrative Contracting Officer (OCT 2020) End of Addendum to 52.212-4 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Products and Commercial Services (OCT 2022) (JUL 2021) (DEVIATION) The following clauses from FAR 52.212-5 apply to this acquisition. (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 4655) (4) 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note) (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C) (8) 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) (31 U.S.C. 6101 note) (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644) (16) 52.219-8, Utilization of Small Business Concerns (OCT 2022) (15 U.S.C. 637(d)(2) and (3)) (19) 52.219-14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 637s) (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (SEP 2021) (15 U.S.C. 632(a)(2)) (27) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755) (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015) (30)(i) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246) (31)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212) (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793) (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212) (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496) (35)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627) (36) 52.222-54, Employment Eligibility Verification (MAY 2022). (Executive Order 12989) (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513) (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (58) 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) (31 U.S.C. 3332) (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services: (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67) (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67) Example: This is not a Wage Determination. This is provided for informational purposes. Recreation Assistant (Yoga Instructor), GS-06, $21.04/hr + 30% Fringe (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards - Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67) (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706) Addendum to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS This addendum is in addition to the current version of FAR 52.212-1 in effect at issuance of this combined synopsis/solicitation. All proprietary information shall be clearly marked. The use of hyperlinks in quotes is prohibited. The contractor is responsible for confirming the Government s receipt of the contractor s quote. Quotes shall include the following information at a minimum in order to be considered: The solicitation number; The time specified in the solicitation for receipt of quotations; The name, address, and telephone number of the quoter; A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, screen shots of digital platform, or other documents, if necessary; Evidence of instructor certifications; Price and any discount terms. Price shall follow the format outlined in Table 1. Contract Line Items on page 5; Remit to address, if different than mailing address; A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the quoter shall complete electronically); Acknowledgment of Solicitation Amendments; Past performance information, to include recent (active within the past 12 months) and relevant contracts for the same or similar items (online wellness classes) and other references (including contract numbers, points of contact with telephone numbers and other relevant information); Statement regarding terms and conditions. 52.212-2 EVALUATION SIMPLIFIED ACQUISITION PROCEDURES Basis for Award. The Government will issue a purchase order to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical and Quality Past Performance Veterans Involvement Price Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2(b)(3) and FAR 13.106-2(b)(4). 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 evaluation will consider the following: Technical and Quality: The quotation will be evaluated to the extent to which it can meet 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. Past Performance: The past performance evaluation will assess the relative risks associated with a quoter s likelihood of success in fulfilling the solicitation s requirements as indicated by the quoter s record of past performance. The past performance evaluation may be based on the contracting officer s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis. Veterans Involvement: In accordance with Veterans Affairs Acquisition Regulation (VAAR) 852.215-70 (DEVIATION), Service-Disabled Veteran-Owned and Veteran-Owned Small Business (VOSB) Evaluation Factors, the Government will assign evaluation credit for a Quoter (i.e., prime contractor) which is a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a VOSB. To receive credit, an offeror must be registered and verified in the VetCert database at time of quotation submission and at time of award (https://veterans.certify.sba.gov/) and must meet federal small business size standards for the North American Industry Classification System (NAICS) code assigned to this solicitation. Non-SDVOSB/VOSB quotations that use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation Factor. Quoters must state in their quotations the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be registered and verified in VetCert https://veterans.certify.sba.gov/) and must meet federal small business size standards for the NAICS code assigned to this solicitation at time of both quotation submission and at time of award. Price: The Government will evaluate the price by adding the total of all line item prices, including all options The Total Evaluated Price will be that sum. Options. The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation. Evaluation of options under FAR 52.217-8 will be accomplished by adding six months of the quoter's price for the last potential period of performance under this contract to the quoter's total price.  For example, if the contract includes option periods that are exercisable under FAR 52.217-9, the quoter's total price for the purpose of evaluation will include the base period, all option periods, and an additional six months of the last option period. Quoters must price only the base and option periods specified in the line item numbers (LINs) and shall not submit a price for the potential six-month extension of services under FAR 52.217-8. The Government reserves the right to exercise the option under FAR 52.217-8 before the end of any of the contractor's performance periods and will be exercised at the price and/or rates in effect at the time the clause is exercised. Evaluation of options shall not obligate the Government to exercise the option(s). To facilitate the award process, all quotes MUST include a statement regarding the terms and conditions herein as follows: ""The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."" OR ""The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"" Quoters shall list exception(s) and rationale for the exception(s), if any. Failure to include a statement regarding the terms will result in the quote no longer being considered. DUE DATES Questions in response to this combined synopsis/solicitation are due by Wednesday, February 22nd, 2023, at 2:00 PM Central Time. Questions will not be entertained after this time. Questions and answers will be published by February 23rd, 2023, via amendment on Contract Opportunities at https://sam.gov/content/opportunities. Quotes are due Friday, February 28th, 2023, at 2:00PM Central Time. POINT OF CONTACT Steven MacDonald Contract Specialist Network Contacting Office 12 steven.macdonald@va.gov
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/6ffcea46000940909fdd5e6f95796e6c/view)
 

Place of Performance

Address: Refer to Performance Work Statement, USA

Country: USA
 

Record

SN06591500-F 20230216/230214230109 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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