Nuclear Radiopharmaceutical

Agency: Department of Veterans Affairs
State: Kentucky
Type of Government: Federal
Category:
  • 65 - Medical, Dental, and Veterinary Equipment and Supplies
Posted: Jan 10, 2019
Due: Jan 18, 2019
Solicitation No: 36C24919Q0107
Publication URL: To access bid details, please log in.
Opportunity History
  • Original Synopsis
    Jan 10, 2019
    1:18 pm
Solicitation Number :
36C24919Q0107
Notice Type :
Sources Sought
Synopsis :
Added: Jan 10, 2019 1:18 pm
The Department of Veterans Affairs Medical Center, NCO 9 Network Contracting Office, on behalf of Lexington VA Medical Center is conducting market research through this sources sought notice to seek sources to identify potential experienced businesses that are capable of meeting the requirements per the Statement of Work (SOW) below. The North American Industry Classification System (NAICS) Code for this acquisition is 325412. Disclaimer and Important Notes: This Sources Sought Notice is for market research purposes only and does not constitute a Request for Proposal/Quotation; and, it is not considered to be a commitment by the Government to award a contract nor will the Government pay for any information provided; no basis for claim against the Government shall arise as a result from a response to this Sources Sought Notice or Government use of any information provided. Failure to submit information in sufficient detail may result in considering a company as not a viable source and may influence competition and set-aside decisions. Regardless of the information obtained from this Sources Sought Notice, the Government reserves the right to consider any arrangement as deemed appropriated for this requirement. 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. No proprietary, classified, confidential, or sensitive information should be included in your response to this Sources Sought Notice. The Government reserves the right to use any information provided by respondents for any purpose deemed necessary and legally appropriate, including using technical information provided by respondents in any resultant solicitation. At this time no solicitation exists; therefore, Do Not Request a Copy of the Solicitation. After a review of the responses received, a pre-solicitation notice and solicitation may be published on Federal Business Opportunities FedBizOpps website. It is the potential offeror's responsibility to monitor FedBizOpps for release of any future solicitation that may result from this Sources Sought Notice. However, responses to this Sources Sought Notice will not be considered adequate responses to any resultant solicitation.
Pursuant to FAR Part 10 (Market Research), the purpose of this notice is to: (1) determine if sources capable of satisfying the agency's requirements exists, (2) determine if commercial items suitable to meet the agency's needs are available or could be modified to meet the agency's requirements, and (3) determine the commercial practices of company's engaged in providing the needed service or supply. Pursuant to FAR Part 6 and FAR Part 19, competition and set-aside decisions may be based on the results of this market research. This notice in no way obligates the Government to any further action.
CCR: Interested parties should register in the SAM as prescribed in FAR Clause 52.232-33. The SAM can be obtained by accessing the internet at www.sam.gov.
Submission of Information: Companies having capabilities necessary to meet or exceed the stated requirements are invited to provide information to contribute to this market survey/sources sought notice including commercial market information and company information. Companies may respond to this Sources Sought Notice via e-mail to Edrick.Thomas@va.gov no later than January 18, 2019 at 8:00 AM, Eastern Time with the following information/documentation:
1. Name of Company, Address and DUNS Number.
2. Point of Contact and Phone Number.
3. Business Size applicable to the NAICS Code: a. HuBZone Small Business ; b. Service-Disabled Veteran Owned Small Business (SDVOSB); c. Veteran Owned Small Business (VOSB); d Small Business; e. Large Business
4. Documentation Verifying Small Business Certification:
a. If claiming HuBZone status, provide a copy of your HuBZone Certificate from SBA.
b. If claiming SDVOSB/VOSB status, provide documentation that shows the business is VetBiz certified.
d. If claiming Small Business status, provide documentation to show the business is small under NAICS code 325412.

CLIN Supplies
QTY
Total Cost
1) BASE PERIOD Nuclear Radiopharmaceutical unit dose delivery. Base Period of Performance: 04/01/2019 to 09/30/2019.

6 MONTHS

2) OPTION YEAR 1: Nuclear Radiopharmaceutical unit dose delivery. Option Year 1: Period of Performance: 10/01/2019 to 09/30/2020.
1 YEAR

3) OPTION YEAR 2: Nuclear Radiopharmaceutical unit dose delivery. Option Year 2: Period of Performance: 10/01/2020 to 09/30/2021.
1 YEAR

4) OPTION YEAR 3: Nuclear Radiopharmaceutical unit dose delivery. Option Year 3: Period of Performance: 10/01/2021 to 09/30/2022.
1 YEAR

5) OPTION YEAR 4: Nuclear Radiopharmaceutical unit dose delivery. Option Year 4: Period of Performance: 10/01/2022 to 09/30/2023.
1 YEAR
Grand Total
_________________


STATEMENT OF WORK

UNIT DOSE RADIOPHARMACEUTICALS
VAMC LEXINGTON, KY NUCLEAR MEDICINE / PET

Contractor must be able to provide emergency orders placed during regular work hours (M-F 6:00 am to 4:00pm) within 1-hour after receipt of phoned or faxed orders from 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.

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 1-hour of placing the order. Emergency and priority studies consist of 20%-30% of the daily schedule.

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
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 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.

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: kelly.gross@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 the4 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.

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: 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 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:

The Offerors ability to meet desired turnaround times as stated in the Statement of Work.
Past performance references.

The solicitation specifies the technical requirements that the VAMC 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 6 months
and four consecutive twelve-month option years.
Please consult the list of document viewers if you cannot open a file.
Attachment
Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Attachment
Posted Date:
January 10, 2019
Description: 36C24919Q0107 36C24919Q0107.docx
Contracting Office Address :
Department of Veterans Affairs;Network Contracting Office 9;1639 Medical Center Parkway;Suite 400;Murfreesboro TN 37129
Place of Performance :
Lexington VA Medical Center;1101 Veterans Drive;Lexington, KY
40502
USA
Point of Contact(s) :
Edrick Thomas
Contracting Officer
edrick.thomas@va.gov

edrick.thomas@va.gov
All Files
Attachment
Jan 10, 2019
36C24919Q0107.docx
General Information
Notice Type:
Sources Sought
Posted Date:
January 10, 2019
Response Date:
January 18, 2019
Archiving Policy:
Automatic, on specified date
Archive Date:
February 17, 2019
Original Set Aside:
N/A
Set Aside:
N/A
Classification Code:
65 -- Medical, dental & veterinary equipment & supplies
NAICS Code:
325 -- Chemical Manufacturing/325412 -- Pharmaceutical Preparation Manufacturing

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Jan 13, 2019[Special Notice] 65--Nuclear Radiopharmaceutical
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