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This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in 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. Â
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This is a request for quote (RFQ), and the solicitation number is 36C25023Q0136. The Government anticipates awarding a firm fixed price, Indefinite Delivery, Indefinite Quantity, Requirements Contract resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars 2022-08, effective 10/28/2022. The associated NAICS Code is 325412, Pharmaceutical Preparation Manufacturing.  Only emailed proposals received by the date indicated, directly from the offeror shall be considered acceptable. Offers will only be considered from Offerors that are licensed by the Nuclear Regulatory Commission who are regularly established in the business of providing radionuclides as called for in this RFQ. Offerors shall provide copies of licenses and certification in response to this RFQ. The successful awardee agrees in accordance with the terms and conditions stated herein, to furnish radiopharmaceuticals in accordance with Local, State, and Federal Regulations. The successful awardee shall be able to provide all of the items listed on the attached Excel Spreadsheet with deliveries when required. Multiple awards will not be made.

The Chalmers P. Wylie VA Ambulatory Care Center (VAACC), Columbus OH has a requirement for a United States Nuclear Regulatory Commission (US NRC), and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The VAACC intends to award a base year plus four option years, firm fixed price, Indefinite Delivery, Indefinite Quantity, Requirements Contract to a licensed Radio-pharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in Ohio with a period of performance of January 6, 2023 through January 5, 2028.

This a 100% Small Business Set Aside.
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Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below.
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Questions pertaining to this solicitation shall be sent by e-mail only to: gina.crank@va.gov no later than 5:00 pm EST, December 09, 2022. Responses to questions received will be posted no later than 5:00 pm EST, December 13, 2022. Telephone inquiries will not be accepted. No response will be provided to questions received after the specified date and time.

Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than December 16,  2022, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.Â
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Statement of Work (SOW):
The Columbus VA Ambulatory Care Center (VAACC), Columbus OH has a requirement for unit dose preparation of radiopharmaceuticals for patient care. The Contractor is to provide unit dose Radiopharmaceutical products, per patient order, as listed herein, as requested by authorized VA Staff, in accordance with Public Law 104-262 and 38 USC 8153 in order to support the VAACC, Columbus OH. Because we do not have the capacity to compound these radiopharmaceuticals in our facility (per USP 797 and USP 825), we are contracting the service of providing the compounding on a unit dose basis, to be delivered to nuclear medicine, calibrated to the proper amount at the proper time, per patient (by physician order), as ordered by 4 pm the day before.

DELIVERIES: Deliveries to VAACC Columbus shall be made to:
Chalmers P. Wylie VA Ambulatory Care Center
Nuclear Medicine Service
420 North James Rd.
Columbus, OH, 43219.

Contractor shall provide routine delivery of items during the hours of 7:30 a.m. to 4:00 p.m., Monday through Friday, excluding holidays. It is anticipated that routine deliveries will be made once or twice daily at 8:00 a.m. and as needed.

All routine deliveries of unit doses per patient, ordered by 4:30 p.m. the previous day, shall be at the VA facility by 8:00 a.m. the next business day. The order shall include the patient name and prescribed radiopharmaceutical.

Emergency and additional request orders may be made and shall be delivered within 45 minutes and one (1) hour of placement of the order, during our normal business hours ( 7:30am to 4:00 pm).

Pre-calibrated doses should not expire within 1 hours of calibration time requested by the Nuclear Medicine Service.

Stat Orders (emergency doses ordered during normal business hours: 7:30 a.m. 4:00 p.m.) shall be delivered within one (1) hour of placement of the order.

The 11 Federal Holidays observed by the Federal Government are:

New Year s Day January 1
Martin Luther King s Birthday 3rd Monday in January
Presidents Day 3rd Monday in February
Memorial Day Last Monday in May
Juneteenth June 19
Independence Day July 4
Labor Day 1st Monday in September
Columbus Day 2nd Monday in October
Veterans Day November 11
Thanksgiving Day 4th Thursday in November
Christmas Day December 25th

The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

All doses provided under this contract shall meet all requirements of the Nuclear Regulatory Commission (NRC). All doses provided under this contract shall be packaged and shipped in accordance with the requirements of the NRC and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and DOT. All doses will be dispensed for the specific amount required for the physician prescribed testing, unless special arrangements are made.

Compliance with all OSHA manufacturing, packaging and shipping regulations is required.

The contractor shall guarantee the quality of all radiopharmaceuticals. Quality control shall include percent tag and MO99 breakthrough as appropriate. The Contractor shall provide Quality Control on each agent dispensed, on request. The Contractor shall guarantee the quality of all doses of radiopharmaceuticals. The Contractor shall provide complete documentation on Quality Control results upon request.

The Contractor shall provide documentation of inventory, disposal and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC).

The Contractor shall provide complete documentation on inventory, disposal and patient dose records upon request.

RECALLED AND DEFECTIVE PRODUCTS: the Contractor will immediately notify the nuclear medicine department, followed by the Contracting Officer, of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e., administrative and clinical services to replace recalled / defective products.

Cost/Price Schedule

The quantities listed on the attached Excel Spreadsheet are yearly estimates only and do not guarantee that the Government will require the total quantities of each item. The contractor is to complete the attached excel spreadsheet. The blank column(s) must be completed (column O and E if you have any comments) for the Base year and all Option Years. If items are available as LEU product, please include only that price, and indicate that it is for the LEU product, vs. the HEU products. Quoted prices must be valid for a minimum of 120 days from date of quote. Any proposed substitute items need to be clearly marked as such and which item the substitution is proposed for. The Ordering Officials will be indicated prior to contract start date.

Designation Of Contract Officer Representation

The Contracting Officer Representative (COR) will be designated in writing. The COR will be furnishing technical guidance, and advice regarding the radiopharmaceuticals being provided under the respective awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice, and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the sole responsibility of the Contracting Officer.

Evaluation Criteria/Submission Of Offer

Evaluation Process: Any award resulting from this solicitation will be completed using the procedures under FAR 13, Simplified Acquisitions Procedures. Offerors will be evaluated utilizing Price, Delivery, and Past Performance. To be considered acceptable, offers must be determined by the Government to fully meet or exceed all standards specified in this solicitation on a pass-fail basis.

Contract Award

Upon Contract Award (within five business days), awarded contractor shall provide:

1. A copy of their laboratory s current quality control manual to the COR.
2. A dedicated inside sales representative to aide in facilitation in the smooth coordination between the Nuclear Medicine Department and the Contractor s Laboratory Pharmacy.
3. Material safety data sheets, and updates on all delivered products as per the awarded contract, and any additions throughout the life of the awarded contract.
4. Patient orientation education video presentations, and other appropriate material at no additional cost to the Government.
5. Signs and posters alerting patients, employees and the public, of safety precautions in handling of radioactive materials.

The following solicitation provisions apply to this acquisition:
FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (JUNE 2020)
FAR 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (FEB 2021)
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 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS
Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:
FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
FAR 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011)
FAR 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014)
FAR 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011)
FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)
FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)

VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) 852.203-70, 852.232-72, 852,233-70, 852.233-71 852.246-71, 852.247-71, 852.270-1
VAAR 852.212-71 GRAY MARKET LANGUAGE (MAY 2016)

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Jan 2021
The following subparagraphs of FAR 52.212-5 are applicable:
[52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-18, 52.232-19, and 52.232-33.]
FAR 52.232-2 SERVICE OF PROTEST (SEPT 2006) - - Hand-Carried Address: Department of Veterans Affairs, Network Contracting Office 10, 2780 Airport Drive, Suite 340, Columbus, OH 43219


BIDDERS SHALL INCLUDE THE FOLLOWING THREE (3) SECTIONS TO THEIR OFFERS:
1. Price: A completed Cost/Price Schedule filled in using the attached Excel spreadsheet. For the purpose of evaluation, the total price (including option periods) will be evaluated.
2. Past Performance to include the following information:
a. Identify at least 3 recent (within the past 3 years) Federal, State, local Government or private contracts that are similar in size and scope to this requirement.
b. Dollar Value
c. Dates of performance
d. Name of Agency/Facility
e. Point of contact along with contact information
f. A brief description of the work effort to demonstrate the relationship between the reference contract and the proposed effort
3. Technical: Description in sufficient detail to allow the Government to ascertain the Offerors capability to meet (in addition to the items listed in the cost/price schedule) the requirements indicated in the SOW, and should include at a minimum the following information:
a. Ability to meet the required delivery timeframes.
b. Ability to meet compliance and regulation requirements.
c. Quality control measures.
d. Ability to supply LEU sourced products by the start date of the award contract.
An Offeror s initial proposal should contain the best terms from a price and technical standpoint. Offerors are reminded that representatives from your company SHALL NOT contact any Columbus VAMC personnel to discuss this RFQ during the solicitation and evaluation process.
Questions pertaining to this solicitation shall be sent by e-mail only to: gina.crank@va.gov no later than 5:00 pm EST, December 09, 2022. Responses to questions received will be posted no later than 5:00 pm EST, December 13, 2022. Telephone inquiries will not be accepted. No response will be provided to questions received after the specified date and time. Quotes shall be sent by e-mail only to: gina.crank@va.gov no later than 5:00 pm EST, December 16, 2022.
See attached documents:
Line item Excel Spreadsheet for Columbus RadioPharm.

Attachments/Links