36C24924Q0169.docx

STATEMENT OF WORK

PYLARIFY; PIFLUFOLASTAT F 18 UNIT DOSE RADIOPHARMACEUTICAL DELIVERY TO THE LEXINGTON, KY VA HEALTH CARE SYSTEM, NUCLEAR MEDICINE/PET/CT DEPARTMENT.

GENERAL INFORMATION

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

POINT OF CONTACT*

Contract Specialist Phon Phasavath Phon.phasavath@va.gov 615-225-3416

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

EMAIL DESCRIPTION

DESCRIPTION

1. On behalf of the Lexington VA Medical Center , Network Contracting Office (NCO) 9 is issuing this sources sought notice (SSN) as a means of conducting market research to identify parties having an interest in, and the resources to support, this requirement for a firm-fixed-priced, Base plus 4 Options, contract for pylarify (piflufolastat 18) injections. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325412 - Pharmaceutical Preparation Manufacturing.

2. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for bids, proposals, or quotes; submission of any information in response to this market survey is purely voluntary; and the government assumes no financial responsibility for any costs incurred.

3. If your organization has the potential capacity to perform these services, please provide the following information:

a. Organization name, address, point of contact, email address, web site address, and telephone number.

b. Business size: small, small disadvantaged, woman-owned, Hub Zone, serviced-disabled veteran-owned small business (SDVOSB), veteran owned small business (VOSB), large business, etc.

c. Business type under NAICS 325412, which contains a size standard of 1,250 employees, Commercial And Government Entity (CAGE) Code and Unique Entity Identification (UEI) Number.

d. Under which NAICS code does your company usually provide the requirements described in the Statement of Work (SOW) - Please provide rationale for your answer if different from NAICS 325412.

e. Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational, and staff capability.

f. Please provide the following information as an attachment to your response:

i. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes.

ii. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each.

iii. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner?

1. Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company.

4. Response to this SSN shall not exceed 10 pages and should include all of the fore-mentioned information. In addition, all submissions should be provided electronically in a Microsoft Word or Adobe Portable Document Format (PDF).

5. The government will evaluate market information to ascertain potential market capacity to:

a. Provide services consistent in scope and scale with those described in this notice and otherwise anticipated. Secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements.

b. Implement a successful plan that includes: compliance with program schedules; cost containment; meeting and tracking performance.

c. Provide services under a firm-fixed-price contract.

6. NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov.

7. Based on the responses to this SSN/market research, this requirement may be set-aside for SDVOSBs, VOSBs, small businesses, procured through full and open competition, or sole sourced.

8. Submission Instructions: Interested parties who consider themselves qualified to perform the services are invited to submit a response to this SSN by 08:00 CDT, February 28, 2024. All responses under this SSN must be emailed to Phon.phasavath@va.gov. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

9. SAM: Interested parties shall be registered in the System for Award Management (SAM) as prescribed in FAR Clause 52.232-33. SAM information can be obtained by accessing the internet at www.sam.gov or by calling 1-866-606-8220.

10. Disclaimer and Important Notes. This notice does not obligate the government to award a contract or otherwise pay for the information provided in response to this SSN. The government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization s qualifications to perform the work. Respondents are advised that the government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities (FBO). However, responses to this notice shall not be considered adequate responses to a solicitation.

11. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

12. See attached SOW.

amount/ year

Total Base Option plus 4 Option Years

Sources Sought Notice Sources Sought Notice Radiopharmaceuticals required: Interested vendors must be able to provide ALL of the following items for a Base period plus 4 Option Years:

Sources Sought Notice

1. Delivery/Scope: Quantities expressed in the schedule are estimates based on usage for one year. Quantities may vary based on patient demand. The initial term of this agreement will be for three years.

· All Radiopharmaceuticals 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:

i. By-product material manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Tile 10, Code of Feral Regulations, Part 35 and the equivalent regulations of an Agreement State.

· All routine orders for F18 Pylarify shall be placed as needed by the Nuclear Medicine Staff at least 48 hours prior to the patient study date and delivered for the specified dates and times. It is understood that orders for the next day must be placed with the Pharmacy by 3:30pm, and that F18 Pylarify is only available for delivery Monday-Friday with an out the door time of 10am. It is understood that doses ordered for the same day delivery will be supplied based on product availability and mutual agreement only.

· The Contractor will ensure that all F18 Pylarify doses are delivered at least 30 minutes prior to the dose calibration time.

· Patients last name only will be entered in the Contractors Web site or via telephone to reserve a dose.

· C&A requirements do not apply, and a Security Accreditation Package is not required.

· 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 by 8am on the scheduled delivery day.

· The first delivery shall be made to Nuclear Medicine (Room A-152a) depending on product availability at minimum 30 minutes before the calibration time unless prior authorization arrangements have been made. Delivery shall be made directly to a Nuclear Medicine Technologists on duty, Deliveries before 6:00am shall be made by contacting the VA Police Department located on the first floor to unlock the Nuclear Medicine Department Night Entry (Room A-152A) for placement of the packages.

· It is understood that there is a no charge for delivery ($0).

· The Contractor shall deliver all radiopharmaceuticals with NO added fuel surcharge.

· Delivery personnel shall be bonded by the Contractor.

· Contractor shall provide evidence of special driver’s licenses required for transporting hazardous materials, and the couriers must be wearing identification tags upon enter the VA.

· Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA, and all other State and Federal rules and regulations.

· 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.

· Contractor will provide a packing list which provides a Description product code, activity amount, Calibration date/time, Expiration date/time, volume, Qty, Rx # with each delivery.

· 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.

· 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 859-381-5927 by 8:00am local time and will not bill the customer.

· Customer must notify Contractor’s Customer Care Team @ _______________by _______am/pm local standard time on the day of the patient’s study to cancel an order or the customer shall be responsible for the payment.

· 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 two per year.

· Federal Holidays will be observed, and the Nuclear Medicine Department will be closed on the days listed below:

- 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.

· Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians.

· Radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date.

· The Radiopharmacy shall be USP <825> 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.

· Personnel 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

2. 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. Invoices shall be submitted electronically for approval to: Jennifer.Coffey@va.gov

· Said invoices will be reviewed by the COR for accuracy and any discrepancies corrected and a new invoice sent before invoice is finalized. All invoices will include the following

a) Name and address of the Contractor

b) Invoice date and purchase order number

c) Contact number or PO#

d) An itemized listing of charges.

· Invoices are to be submitted by the contractor to the Invoice Processing Payment System for payment.

· Contractor shall be paid monthly, in arrears, upon a submission of a properly prepared invoice for services / supplies during the period.

· Payment is to be made to:

Awarded Contractor

e) 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.

· 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.

A) 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.

B) 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.

C) Evaluation Methodology: The Government intends to award this contract based on the lowest price technically acceptable.

· The Government intends to award one Firm Fixed Price requirement contract if applicable to the responsible Offeror summiting proposals that are determined to be lowest price technically acceptable. Lowest Price, Technically Acceptable (LPTA) means that the award will be made to the Offeror whose price is lowest among all proposals that were deemed to be technically acceptable.

· Technically acceptable will be measured minimally by:

1) The Offerors ability to meet desired turnaround times as stated in the Statement of Work.

2) Past performance references.

· The solicitation specifies the technical requirements that the VA Health Care System has established above in the detailed Statement of Work (SOW) the award will be made based on the lowest “aggregate” price of proposals meeting or exceeding the acceptable standards for non-cost factors in accordance with FAR 15.101-2(b)(1).

· The Government intends to award this contract on a base period of 12 months and FOUR (4) consecutive twelve-month option years.

The total estimate value for this contract may increase or decrease upon Provider demand.