Inactive

Description This is a solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures f... Description This is a 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 FAC 2023-01, effective December 30, 2022. This solicitation is for 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 VA Medical Center is seeking to purchase various radiopharmaceuticals for a Base period of 12 months plus four (4) 12-month options. All interested companies shall provide quotations for the following: Vendor MUST be able to provide ALL items in order to be determined responsive. All quantities are ESTIMATED. Supplies/Services Item Number Description ESTIMATED Quantity Unit of Measure Unit Price Extended Price 0001 F-18 FDG 10mCi 400 EA   0002 Ga-67 (per mCi) 6 EA   0003 I-123 200uCi Uptake Caps 12 EA   0004 I-131 Diagnostic Cap (5mCi) 20 EA   0005 I-131 Therapeutic dose (per mCi) physician ordered 1200 EA   0006 I-131 Uptake Caps .02mCi 1 EA   0007 In-111 Octreoscan (pentatreotide) 6mCi 2 EA   0008 In-111 WBC Kit/Labeling 1mCi 1 EA   0009 PYP Vial 15 EA   0010 Kinevac (CCK) 50 EA   0011 Tc-99m Exametazime * 25mCi 1 EA   0012 Tc-99m HMPAO WBC Kit/Labeling 20mCi 1 EA   0013 Tc-99m Macroaggregated Albumin (MAA) 3mCi 25 EA   0014 Tc-99m Mebrofenin (Choletec) 5mCi 50 EA   0015 Tc-99m Medronate (MDP) 25mCi 250 EA   0016 Tc-99m MAG3 (mertiatide) 6mCi 30 EA   0017 Tc-99m Pentetate (DTPA) 30mCi 30 EA   0018 Tc-99m pyrophosphate (Hot PYP) 20mCi 15 EA   0019 Tc-99m sestamibi 25mCi 50 EA   0020 Tc-99m sodium pertechnetate (TcO4) 20mCi 90 EA   0021 Tc-99m sulfur colloid dmCi 50 EA   0022 Tc-99m sulfur colloid filtered 1mCi 1 EA   0023 Tc-99m TcO4 LINEARITY SOURCE 300mCi 4 EA   0024 Tc-99m Myoview 15mCi 1500 EA   0025 Tl-201 (per mCi) 4mCi 16 EA   0026 Tc-99m UltraTag Kit 1 EA   0027 Hot Lab Management Software 1 EA   1001 F-18 FDG 10mCi 400 EA   1002 Ga-67 (per mCi) 6 EA   1003 I-123 200uCi Uptake Caps 12 EA   1004 I-131 Diagnostic Cap (5mCi) 20 EA   1005 I-131 Therapeutic dose (per mCi) physician ordered 1200 EA   1006 I-131 Uptake Caps .02mCi 1 EA   1007 In-111 Octreoscan (pentatreotide) 6mCi 2 EA   1008 In-111 WBC Kit/Labeling 1mCi 1 EA   1009 PYP Vial 15 EA   1010 Kinevac (CCK) 50 EA   1011 Tc-99m Exametazime * 25mCi 1 EA   1012 Tc-99m HMPAO WBC Kit/Labeling 20mCi 1 EA   1013 Tc-99m Macroaggregated Albumin (MAA) 3mCi 25 EA   1014 Tc-99m Mebrofenin (Choletec) 5mCi 50 EA   1015 Tc-99m Medronate (MDP) 25mCi 250 EA   1016 Tc-99m MAG3 (mertiatide) 6mCi 30 EA   1017 Tc-99m Pentetate (DTPA) 30mCi 30 EA   1018 Tc-99m pyrophosphate (Hot PYP) 20mCi 15 EA   1019 Tc-99m sestamibi 25mCi 50 EA   1020 Tc-99m sodium pertechnetate (TcO4) 20mCi 90 EA   1021 Tc-99m sulfur colloid dmCi 50 EA   1022 Tc-99m sulfur colloid filtered 1mCi 1 EA   1023 Tc-99m TcO4 LINEARITY SOURCE 300mCi 4 EA   1024 Tc-99m Myoview 15mCi 1500 EA   1025 Tl-201 (per mCi) 4mCi 16 EA   1026 Tc-99m UltraTag Kit 1 EA   1027 Hot Lab Management Software 1 EA   2001 F-18 FDG 10mCi 400 EA   2002 Ga-67 (per mCi) 6 EA   2003 I-123 200uCi Uptake Caps 12 EA   2004 I-131 Diagnostic Cap (5mCi) 20 EA   2005 I-131 Therapeutic dose (per mCi) physician ordered 1200 EA   2006 I-131 Uptake Caps .02mCi 1 EA   2007 In-111 Octreoscan (pentatreotide) 6mCi 2 EA   2008 In-111 WBC Kit/Labeling 1mCi 1 EA   2009 PYP Vial 15 EA   2010 Kinevac (CCK) 50 EA   2011 Tc-99m Exametazime * 25mCi 1 EA   2012 Tc-99m HMPAO WBC Kit/Labeling 20mCi 1 EA   2013 Tc-99m Macroaggregated Albumin (MAA) 3mCi 25 EA   2014 Tc-99m Mebrofenin (Choletec) 5mCi 50 EA   2015 Tc-99m Medronate (MDP) 25mCi 250 EA   2016 Tc-99m MAG3 (mertiatide) 6mCi 30 EA   2017 Tc-99m Pentetate (DTPA) 30mCi 30 EA   2018 Tc-99m pyrophosphate (Hot PYP) 20mCi 15 EA   2019 Tc-99m sestamibi 25mCi 50 EA   2020 Tc-99m sodium pertechnetate (TcO4) 20mCi 90 EA   2021 Tc-99m sulfur colloid dmCi 50 EA   2022 Tc-99m sulfur colloid filtered 1mCi 1 EA   2023 Tc-99m TcO4 LINEARITY SOURCE 300mCi 4 EA   2024 Tc-99m Myoview 15mCi 1500 EA   2025 Tl-201 (per mCi) 4mCi 16 EA   2026 Tc-99m UltraTag Kit 1 EA   2027 Hot Lab Management Software 1 EA   3001 F-18 FDG 10mCi 400 EA   3002 Ga-67 (per mCi) 6 EA   3003 I-123 200uCi Uptake Caps 12 EA   3004 I-131 Diagnostic Cap (5mCi) 20 EA   3005 I-131 Therapeutic dose (per mCi) physician ordered 1200 EA   3006 I-131 Uptake Caps .02mCi 1 EA   3007 In-111 Octreoscan (pentatreotide) 6mCi 2 EA   3008 In-111 WBC Kit/Labeling 1mCi 1 EA   3009 PYP Vial 15 EA   3010 Kinevac (CCK) 50 EA   3011 Tc-99m Exametazime * 25mCi 1 EA   3012 Tc-99m HMPAO WBC Kit/Labeling 20mCi 1 EA   3013 Tc-99m Macroaggregated Albumin (MAA) 3mCi 25 EA   3014 Tc-99m Mebrofenin (Choletec) 5mCi 50 EA   3015 Tc-99m Medronate (MDP) 25mCi 250 EA   3016 Tc-99m MAG3 (mertiatide) 6mCi 30 EA   3017 Tc-99m Pentetate (DTPA) 30mCi 30 EA   3018 Tc-99m pyrophosphate (Hot PYP) 20mCi 15 EA   3019 Tc-99m sestamibi 25mCi 50 EA   3020 Tc-99m sodium pertechnetate (TcO4) 20mCi 90 EA   3021 Tc-99m sulfur colloid dmCi 50 EA   3022 Tc-99m sulfur colloid filtered 1mCi 1 EA   3023 Tc-99m TcO4 LINEARITY SOURCE 300mCi 4 EA   3024 Tc-99m Myoview 15mCi 1500 EA   3025 Tl-201 (per mCi) 4mCi 16 EA   3026 Tc-99m UltraTag Kit 1 EA   3027 Hot Lab Management Software 1 EA   4001 F-18 FDG 10mCi 400 EA   4002 Ga-67 (per mCi) 6 EA   4003 I-123 200uCi Uptake Caps 12 EA   4004 I-131 Diagnostic Cap (5mCi) 20 EA   4005 I-131 Therapeutic dose (per mCi) physician ordered 1200 EA   4006 I-131 Uptake Caps .02mCi 1 EA   4007 In-111 Octreoscan (pentatreotide) 6mCi 2 EA   4008 In-111 WBC Kit/Labeling 1mCi 1 EA   4009 PYP Vial 15 EA   4010 Kinevac (CCK) 50 EA   4011 Tc-99m Exametazime * 25mCi 1 EA   4012 Tc-99m HMPAO WBC Kit/Labeling 20mCi 1 EA   4013 Tc-99m Macroaggregated Albumin (MAA) 3mCi 25 EA   4014 Tc-99m Mebrofenin (Choletec) 5mCi 50 EA   4015 Tc-99m Medronate (MDP) 25mCi 250 EA   4016 Tc-99m MAG3 (mertiatide) 6mCi 30 EA   4017 Tc-99m Pentetate (DTPA) 30mCi 30 EA   4018 Tc-99m pyrophosphate (Hot PYP) 20mCi 15 EA   4019 Tc-99m sestamibi 25mCi 50 EA   4020 Tc-99m sodium pertechnetate (TcO4) 20mCi 90 EA   4021 Tc-99m sulfur colloid dmCi 50 EA   4022 Tc-99m sulfur colloid filtered 1mCi 1 EA   4023 Tc-99m TcO4 LINEARITY SOURCE 300mCi 4 EA   4024 Tc-99m Myoview 15mCi 1500 EA   4025 Tl-201 (per mCi) 4mCi 16 EA   4026 Tc-99m UltraTag Kit 1 EA   4027 Hot Lab Management Software 1 EA    Total     All quoters shall submit the following: Technical or Quality: Provide the extent to which the proposed item(s) 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. Past Performance: Provide verifiable past performance evaluations - minimum of 2, maximum of 3 - of similar contracts performed. 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. Price: The Government will evaluate the price by adding the total of all line item prices. -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 contract line item numbers (CLINs), 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). -36C24923Q0449 Line Item Spreadsheet (attached) with all columns highlighted in yellow completed. All quotes shall be sent to Martha.Warren1@va.gov. 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 award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. Additional Solicitation Terms and Conditions. This is a Full and Open Competition solicitation. This RFQ closes August 18, 2023, at 16:00 CDT. Submit all quotes and applicable attachments by e-mail to martha.warren1@va.gov with subject line RFQ 36C24923Q0449 Radiopharmaceuticals-LEX by Friday, August 18, 2023, at 16:00 hours (CDT). Final Offer package will be put into attachments and emailed to martha.warren1@va.gov. Multiple emails will not be accepted. Our email server has a size limitation of 30 GB. Zip files will be removed and therefore, will not be considered. Email attachment must be in .pdf format and in the English language. Font type & size must be appropriate for easy and quick viewing, 10 point or greater. Only acceptable font types are Calibri, Times New Roman, Courier, or Arial. Documents must only be 8 ½ x 10 inches in size, with one-inch margins all around. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Must include offer s UEI Unique Entity Identification 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:" Quoter shall list exception(s) and rationale for the exception(s). Phone calls and fax will not be accepted, all questions or concerns must be submitted via email to martha.warren1@va.gov, with subject line Questions- RFQ 36C24923Q0449 Radiopharmaceuticals-LEX by Friday, August 11, 2023, at 16:00 hours (CDT). The Government reserves the right to make no award at all.

Inactive

The Department of Veterans Affairs, Network Contracting Office - NCO 9, intends to release a Request for Quotes (RFQ). We are seeking quotes on the following: ***Radiopharmaceuticals-LEX *** The North... The Department of Veterans Affairs, Network Contracting Office - NCO 9, intends to release a Request for Quotes (RFQ). We are seeking quotes on the following: ***Radiopharmaceuticals-LEX *** The North American Industry Classification System (NAICS) Code for this RFQ is 325412 Pharmaceutical Preparation Manufacturing, with a Size Standards of 1,300 employees, and Product Service Code (PSC) of 6505 Drugs and Biologicals. This is a Firm-Fixed Price, Base + 4 Option Years, FOB Destination, requirement, and intended as Unrestricted. All RFQ details, to include full specifications, will be included in Section B of the RFQ, which will be released on, or about, July 26, 2023. Any contractor who wishes to receive a copy of the RFQ should monitor this posting. Due date for submission of quote will be on, or about, August 16, 2023, at 16:00 pm Central Daylight Time (CDT). RFQ response shall be submitted via email referencing the RFQ - 36C25523Q00449 Radiopharmaceuticals-LEX in the subject line to martha.warren1@va.gov. Questions regarding this RFQ shall be submitted by August 9, 2023, at 16:00 pm CDT via email referencing the RFQ - 36C25523Q0449 Radiopharmaceuticals-LEX in the subject line to martha.warren1@va.gov. All amendments, other information pertaining to this Request for Quote, and answers to the submitted questions will be posted on the Sam website at https://sam.gov/content/home. Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.11 states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database. All Veteran Owned Small Business (VOSB), Service-Disabled Veteran Owned Small Businesses (SDVOSB) shall be verified in VetBiz at www.vetbiz.va.gov. Non-OEM firms must submit their Authorized Distributor Letter with the quote. Point of Contact for this RFQ is: Martha Warren Department of Veterans Affairs Network Contracting Office - 9 1639 Medical Center Parkway, Ste. 400 Murfreesboro, TN 37129 martha.warren1@va.gov (615) 225-6404 Radiopharmaceuticals required: Interested vendors must be able to provide ALL of the following items for a Base period plus 4 Option Years: Line Item Radiopharmaceutical ESTIMATED QTY UNIT  Base Year   0001 F-18 FDG 400 dose 0002 Ga-67 (per mCi) 6 per mCi 0003 I-123 200uCi Uptake Caps 12 per cap 0004 I-131 Diagnostic Cap (5mCi) 20 per cap 0005 I-131 Therapeutic dose (per mCi) 1200 per mCi 0006 I-131 Uptake Caps 1 per cap 0007 In-111 Octreoscan (pentatreotide) 2 dose 0008 In-111 WBC Kit/Labeling 1 per kit 0009 PYP Vial 15 per vial 0010 Kinevac (CCK) 50 per mcg/vial 0011 Tc-99m Exametazime * 1 per dose 0012 Tc-99m HMPAO WBC Kit/Labeling 1 per kit 0013 Tc-99m Macroaggregated Albumin (MAA) 25 dose 0014 Tc-99m Mebrofenin (Choletec) 50 dose 0015 Tc-99m Medronate (MDP) 250 dose 0016 Tc-99m MAG3 (mertiatide) 30 dose 0017 Tc-99m Pentetate (DTPA) 30 dose 0018 Tc-99m pyrophosphate (Hot PYP) 15 dose 0019 Tc-99m sestamibi 50 dose 0020 Tc-99m sodium pertechnetate (TcO4) 90 dose 0021 Tc-99m sulfur colloid 50 dose 0022 Tc-99m sulfur colloid filtered 1 dose 0023 Tc-99m TcO4 LINEARITY SOURCE 4 per vial 0024 Tc-99m Myoview 1500 dose 0025 Tl-201 (per mCi) 16 per mCi 0026 Tc-99m UltraTag Kit 1 per kit 0027 Hot Lab Management Software 1 per year STATEMENT OF WORK UNIT DOSE RADIOPHARMACEUTICALS LEXINGTON VA HEALTHCARE SYSTEM LEXINGTON, KY NUCLEAR MEDICINE & PET/CT Contractor must be able to provide same day orders placed during regular work hours (M-F 6:00 am to 4:00pm) to the VAMC Lexington, Ky. DELIVERY/SCOPE: Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities and types of radiopharmaceuticals may vary based on patient demand. terms All radiopharmaceuticals and pharmaceuticals or kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable local, State and Federal laws. 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 Tile 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. All radiopharmaceutical items, possibly including some not listed, shall be ordered as needed by the Nuclear Medicine staff and delivered with daily routine deliveries. If the ordered radiopharmaceutical is not available and cannot be delivered to the VA when needed, the contractor will notify the VA Nuclear Medicine Department and obtain the needed doses from another source, including another Radiopharmacy, to be delivered as near the requested time to provide timely care to the Veteran patients. The Contractor may only substitute another radiopharmaceutical for the requested one with VA Nuclear Medicine approval. When this is done, the VA will pay for the lower priced radiopharmaceutical. No delivery charge shall be made for additional deliveries up to 5 per day during normal working hours 6:00 am-4:00 pm. The Contractor shall deliver all radiopharmaceuticals with NO added fuel surcharge. Requests for emergency doses during regular work hours (M-F 6:00 am- 4:00 pm) shall be delivered within 2-hours of placing the order. Emergency and priority studies consist of up to 20% of the daily schedule. Nonemergency doses will be delivered no later than 30 minutes before calibration time. The first daily delivery shall be made to Nuclear Medicine (Room A-152a) by 6:30a.m. unless prior authorization arrangements have been made. Delivery shall be made directly to a Nuclear Medicine Technologist on duty. Deliveries made before staff arrives shall be made by contacting the Veterans Medical Center Police Department to unlock the Nuclear Medicine Department Night Entry (Room a-152) for placement of the packages. Subsequent deliveries will likewise be made as needed as described above. Delivery personnel shall be bonded by the Contractor. Contractor shall provide evidence of special driver s licenses required for transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA, and all other State and Federal rules and regulations. Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, i.e. All waste shall be picked up with the next delivery. All radiopharmaceuticals shall be delivered in proper shielded containers with disposal impenetrable biohazard liners. Shipping containers and their labeling must comply with all federal and state regulations. All unit dose radiopharmaceuticals delivered must have a bar code for scanning into a dose tracking system. Any recalled / incorrectly delivered dose for any reason shall be credited for the full amount. It is the offerors responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defected. Notification shall be made to the Contracting Officer Representative via the most expedient method. Incorrectly delivered doses shall not exceed one per month. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. 4 per year. Weekend delivery (Saturday/Sunday) and all observed Federal Holliday deliveries shall be made by contacting the Veterans Medical Center Police Department to unlock the Nuclear Medicine Department Night Entry (Room A-152) for placement of the packages. New Year s Day Martin Luther King s Birthday Presidents Day Memorial Day Juneteenth Independence Day Columbus Day Veterans Day Thanksgiving Christmas Day Any other day declared a Federal Holiday by the US President. Emergency call back fees shall not be charged for regular work hours (M-F 6:00 am-4:00 pm) on days not observed as a holiday by the VA, i.e. Christmas Eve, Good Friday, etc. Contractor shall provide a quarterly linearity source. The activity requested can range from 25 to 400 mCi. Contractor shall provide leukocyte and platelet labeling services as a same day service. Contractor shall provide 24 hour on-call service for emergency procedures Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, patient education, etc. The majority if not all technetium products must be compounded using Non- HEU generators whenever possible. Radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be tested. The Radiopharmacy shall be USP <797> compliant for sterile compounding and shall provide a statement to this effect. Product information including suppliers source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided upon request at no additional charge. Consultation services regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge. It is preferred that the contractor furnish a VA OIT approved hot lab management system that facilitates required record keeping (and report generation) for regulatory compliance and modernized processes. PERSONNELL AUTHORIZED TO PLACE ORDERS: The following personnel are authorized to telephone and or fax radiopharmaceutical orders: Supervisory Nuclear Medicine Technologist Nuclear Medicine / PET Technologist Other Lexington VA Medical Staff as designated INVOICING: Contracting Officer Representative (COR) shall be provided with a copy of the invoice at the end of each month for approval before submission to the Contract Radiopharmacy s Business Center for processing. Said invoices will be reviewed by the COR for accuracy and any discrepancies corrected and a new invoice sent before invoice is finalized. Contractor shall be paid monthly, in arrears, upon a submission of a properly prepared invoice for services / supplies during the period. All invoices will include the contact number, date of services, and an itemized listing of charges. Invoices shall be submitted electronically to: Jennifer.Coffey@va.gov. PERFORMANCE / QUALITY: Incorrectly delivered doses shall not exceed one per month. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. 4 per year. It is the offerors 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 Representative via the most expedient method. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated. Contractor shall provide complete documentation of quality control results upon request. Product information including suppliers 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. Offeror will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. 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. 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 Medicines 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. 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. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. 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. d. 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. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. 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. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. 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. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. 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. k. 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. l. 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. 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 those personnel: workers compensation professional liability insurance, health examinations, income tax withholding and Social Security payments. Such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor. EVALUATION METHODOLOGY: Award shall be made to the quoter whose quotation considering technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria: (1) technical capability factor "meeting or exceeding the requirement , (2) past performance, and (3) price. The C&A requirements do not apply, the Security Accreditation Package is not required. Any offered Hot Lab Management system will not be connected to the VA network but will house VA sensitive information. We request that the data be available to back up locally, in an OIT approved manner, removing contracting personnel from any security risk.