36C24420Q0005-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Wilkes-Barre Radiopharmaceutical 19104 36C24420Q0005 09-25-2019 N 325412 Department of Veterans Affairs Network Contracting Office 4 3900 Woodland Ave Philadelphia, PA 19104-4551 Louellen Butler Wilkes-Barre VA Medical Center Diagnostic Imaging Section of Nuclear Medicine Room 209 1111 East End Blvd.

Wilkes-Barre, PA 18711-0030

USA

Louellen.Butler@va.gov Louellen.Butler@va.gov FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE

(MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Wilkes-Barre Radiopharmaceutical 19104 36C24420Q0005 09-24-2019 N 325412 Department of Veterans Affairs Network Contracting Office 4 3900 Woodland Ave Philadelphia, PA 19104-4551 Louellen Butler Wilkes-Barre VA Medical Center Diagnostic Imaging Section of Nuclear Medicine Room 209 1111 East End Blvd.

Wilkes-Barre, PA 18711-0030

USA

Louellen.Butler@va.gov Louellen.Butler@va.gov

(i) This is a combined synopsis/solicitation BRAND NAME OR EQUAL base year, with a (4) four-year option contract for Radiopharmaceuticals to perform various nuclear medicine procedures/treatment, as prepared in accordance with the format in Federal Acquisition Regulations (FAR) 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. A firm-fixed price purchase order is anticipated.

(ii) The solicitation number is 36C24420Q0005 and is issued as a request for quotation (RFQ).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2019-02 dated 5/6/2019.

(iv) This solicitation is full and open competition and the associated NAICS code 325412 and the size standard is 1250 Employees.

(v) Statement of Need

VA Wilkes-Barre VA Medical Center Imaging Service: The Wilkes-Barre VA Medical Center has a requirement for a base year, (4) four-year option Radiopharmaceutical Contract.

This requirement is for the Radiopharmaceutical Contract- Base Year, (4) four-Year Option.

Wilkes-Barre VA Medical Center requires a licensed vendor by the Nuclear Regulatory Commission to provide radiopharmaceuticals and calibration sources for the Nuclear Medicine Department. These radiopharmaceuticals are required for imaging procedures. The calibration sources are required for equipment quality control testing. These items are to be delivered directly to the Diagnostic Imaging section of Nuclear Medicine (Imaging Service), room 209, Wilkes-Barre VA Medical Center, 1111 East End Blvd., Wilkes-Barre, PA 18711-0030.

Project Scope of Work The Wilkes-Barre VA Medical Center in Wilkes-Barre, PA, located at 1111 East End Blvd, Wilkes-Barre, PA. 18711 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 Wilkes-Barre VA Medical Center in Wilkes-Barre, PA 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 Pennsylvania with a period of performance of October 1, 2019 through September 30, 2024. 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 in the Schedule of Supplies with deliveries when required. Multiple awards will not be made.

BACKGROUND

The Wilkes-Barre VA Medical Center in Wilkes-Barre, Pennsylvania, is responsible for providing high quality and timely commodities and services for our Veterans. The Department of Veterans Affairs (VA) has been directed to preferentially procure medical radioisotopes from non-High Enriched Uranium (HEU) sources. The Department of Veterans Affairs (VA) is also directed to ensure that the best possible medical supplies are procured timely and in accordance with proper regulations with vendors that are licensed and monitored according to Local, State, and Federal Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (NRC) is responsible for regulating uses of radioactive material including radio pharmaceuticals. The NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. The NRC has transferred regulatory authority over the use of this material to 35 NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA’s Center for Drug Evaluation and Research regulates the radio pharmaceuticals, ensuring effectiveness and patient safety. The mission of the National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.

STATEMENT OF WORK:

1. Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA, on a daily and or as needed basis in accordance with this Statement of Work. Because of the critical need for these supplies in a timely manner, only contractors that can deliver in less than 15 minutes to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA need to respond to this Solicitation. Contractor shall be licensed by the State of Pennsylvania. Additionally, the Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides Delaware and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their proposal. Contractor shall provide evidence of delivery in less than 15 minutes with this Solicitation. Please identify the location of the point of shipment to the address listed on this Solicitation. Verification will be completed via www.mapquest.com.

2. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal and or State standards relating to shipment of radioactive materials.

Shipping containers must comply with all Federal and State regulations. This will include FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided.

3. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.

4. Contractor shall label all products delivered as to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA with the radiopharmaceutical, activity, time of preparation, and expiration time and date.

5. Contractor shall hold a current unrevoked NRC and or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. Contractor shall provide a copy of their radioactive material license with their proposal. Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR), upon any action by the NRC or an agreement state and or FDA to suspend or modify the radioactive materials license. Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and applicable FDA requirements. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

6. Contractor will provide with their proposal, the following information:

a. Contractor’s regular work hours.

b. Contractor’s telephone number for call-in orders during regular work hours.

c. Contractor’s telephone number and instructions for placing emergency orders after contractor’s regular work hours to include weekends.

d. Contractor’s telephone number for expert advice concerning awarded products.

e. Contractor will furnish a statement that any radiopharmaceuticals delivered as “ready-to- use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of the Joint Commission (JC) and or with the United States Pharmacopeia.

f. Should any changes occur in the above information during the contract period of performance, contractor will immediately provide updates in writing.

7. Current package inserts of all radiopharmaceuticals supplied under the awarded contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR Wilkes-Barre VA Medical Center in Wilkes-Barre, PA Nuclear Medicine Service.

8. Contractor shall make quality control records available to the COR upon written request from the CO or COR.

9. Contractor shall test all products for quality control. Periodically, this testing shall be performed at no cost to the Government. The contractor shall provide a detailed description of the test upon request.

10. Calibration time for each requested radiopharmaceutical is given in the Schedule of Supplies, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

11. If an ordered dosage of radioactive material is given to Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

12. Technetium product radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit will be reflected in the current month’s invoice.

13. Contractor shall replace any items delivered damaged or in error at no cost to the Government. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with the needs of the patient.

14. The expiration date and time shall be indicated and affixed to each product as noted below; in general:

a. Ready-to-use doses: not shorter than six (6) hours.

b. Tc-99m Pertechnetate: Not shorter than twelve (12) hours.

c. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery.

d. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span.

15. In the event that a quality control or material defect is suspected or detected by the COR, the Contractor will be required to provide any consultation necessary to alleviate any said suspicion or defect by the following:

a. Provide technical expertise in calibration;

b. Provide professional examination of product; submit results and recommendations to the COR;

c. Make expedient replacement of any product suspected of being deficient.

16. Procedure for labeling of patient's White Blood Cells (WBC) with Indium-111 Oxine or Tc- Ceretec for re-injecting to the same patient:

a. Telephone requests to the Contractor to arrange for the procedure will take place no later than 2:00 PM for the next workday procedure.

b. Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Contractor will be at 7:30 AM or later, if so specified by the COR.

c. The return by the Contractor, of the patient's Indium labeled White Blood Cells will take place not later than within 5 (five) hours from the time of specimen pick up time.

d. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure.

17. Contractor shall pick up Radiopharmaceuticals (used or unused) for proper disposal at no cost to the Government.

18. Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies.

D. Deliverables and Acceptance Criteria

1. Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below:

a. Provide up to two deliveries per day during regular operating hours to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA at 7:30am and 9:30am at no additional charge followed by a third delivery if necessary. The fourth delivery of the day will be considered an emergency.

b. Orders can be placed orally by telephone or fax transmission by ordering officers provided by the Contracting Officer Representative.

c. Deliver directly to the Nuclear Medicine Service Wilkes-Barre VA Medical Center in Wilkes-Barre, PA quantity of radiopharmaceutical requested on an as needed or emergent basis to arrive in less than 15 minutes after notification.

2. If Monday is a federal holiday, no deliveries will be expected. Holidays are listed under section E.

3. Record tracking: Contractor will provide an electronic Nuclear Medicine Information System (NMIS) and all relevant upgrades/repairs available to the Nuclear Medicine department for patient dose record tracking. Daily dose administration reports generated by the NMIS will be returned to Contractor.

E. VA OPERATING HOURS

The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. The Contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and below.

The following terms have the following meanings:

Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30 AM to 4:30 PM. Deliveries shall be accomplished by 7:30 AM and on an as needed basis during normal operating hours.

National Holidays: The ten holidays observed by the Federal Government are:

New Year's Day, Martin Luther King's Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, Christmas, and any other day specifically declared by the President of the United States to be a national holiday Radiopharmaceutical Listing:

The below radiopharmaceutical products are needed to meet the agency’s need, however request for radiopharmaceuticals is not limited to this list. Estimated quantities below are for a period of twelve months.

(vii) All items shall be delivered to the following location:

Wilkes-Barre VA Medical Center Room 209 1111 East End Blvd.

Wilkes-Barre, PA 18711-0030

(viii) The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and the following clauses AND instructions are added as addenda:

Addendum to FAR 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition and the following clauses AND instructions are added as addenda:

52.252-1 Solicitation Provision Incorporated by Reference (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with 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 offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/ https://www.va.gov/oal/library/vaar/index.asp

52.204-13 System for Award Management (OCT 2018) 52.204-18 Commercial and Government Entity Code Reporting (JUL 2016)

The following instructions are added as addenda:

a. Gray market items are Original Equipment Manufacturer’s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufacturers or gray market items will be acceptable.

b. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

c. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

(End of provision)

(ix) 52.212-2 EVALUATION—COMMERCIAL ITEMS (October 2014) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price, and other factors considered. The following factors shall be used to evaluate offers: Technical Approach and Capability, Past Performance, and Price.

Factor I - Technical Approach and Capability Subfactor 1: Vendor must include a copy of their Nuclear Pharmacy License Subfactor 2: Vendor must show ability to deliver products Monday through Friday by 7:30 AM. Vendor must provide a MapQuest illustration showing their ability to deliver.

Subfactor 3: Vendor must provide an emergency plan procedure for deliveries in inclement weather.

Factor II – Past Performance The Offeror shall provide a minimum of three (3) references of current contracts within the past three (3) years of similar size, scope, and or complexity. References may include Federal, State, and Local Government as well as private customers and shall include the following information:

Name and address of the Contracting Activity (Medical Center or Company).

Names, email addresses, and telephone numbers of two points of contact (Contracting Officer and Customer) that would have firsthand knowledge on the performance of the contract.

Contract type, scope of work, and contract total dollar value.

Contract number to include the beginning date and ending date of the contract period of performance.

The past performance evaluation factor will assess the relevance and breadth of the offeror’s experience and the quality of the offeror’s past performance. The Government is seeking to determine whether the offeror has experience that will enhance its technical capability to perform and whether the offeror consistently delivers quality services in a timely and cost effective manner. In evaluating past performance, the Government will only take into consideration the relevant experience from the offeror’s customers.

Information obtained from the offerors through the PPIRS database and any other sources deemed appropriate will be used by the Government in conducting past performance evaluations. The Government will analyze the historical facts of the offerors past performance made by its customers,and make qualitative judgements about the facts and observations. Offeror’s may provide information on problems encountered on identified contracts and the offeror’s corrective action. The Government shall determine the relevance of similar past performance information.

In accordance with FAR 15.305(a)(2)(iv) offeror’s with no relevant performance history shall not be evaluated favorably or unfavorably on past performance.

Factor III – Price In accordance with FAR 17.206 price will be evaluated for the entire contract period, including the base year and both option years. Price evaluation will be undertaken in accordance with FAR 12.209.

All evaluation factors except price shall be evaluated as either acceptable or unacceptable. Your proposal must meet all the requirements identified in the SOW. If your proposal does not meet all of the SOW requirements it will be evaluated as unacceptable and will receive no further consideration for award. If your proposal does not provide pricing for all of the Schedule of Supplies it will be evaluated as unacceptable and will receive no further consideration for award. Price is the most important evaluation factor, followed by technical approach and capability, and then past performance.

At a minimum, proposals must include the following:

(x) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov.

(xi) The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and the following clauses are added as addenda:

Addendum to FAR 52.212-4, Contract Terms and Conditions – Show FAR Clauses followed by VAAR clauses.

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far

52.204-13 System for Award Management Maintenance (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (JUL 2016) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

(End of Clause)

CLAUSES:

852.203-70 Commercial Advertising (JAN 2008) 852.211-70 Equipment Operation and Maintenance Manuals (NOV 2018) 852.219-74 Limitations on Subcontracting – Monitoring and Compliance (JUL 2018) 852.219-75 Subcontracting Commitments Monitoring and Compliance (JULY 2018) 852.232-72 Electronic Submission of Payment Requests (NOV 2018 852.246-71 Rejected Goods (OCT 2018) 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders- Commercial Items (MAY 2019)

(xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and the following additional FAR clauses cited in the clause are applicable to the acquisition:

52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2015) 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015) 52.219-28 Post Award Small Business Program Representation (JUL 2013) 52.222-19 Child Labor--Cooperation with Authorities and Remedies (FEB 2016) (E.O. 13126) 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (APR 2015) 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014) 52.222-50 Combating Trafficking in Persons (MAR 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) 52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014) 52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008) 52.232-34 Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

(xiii) Additional conditions:

All responses must include verification that each specification outlined in Section (v) is met and provide authorized distributor documentation of products offered.

All interested parties shall be registered, active and verified with the following sites to be considered for award.

• SAM: http://www.sam.gov

• VETBIZ: https://www.vip.vetbiz.gov/Public/Search/Default.aspx

(xiv) The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.

(xv) This is an open-market combined synopsis/solicitation for equipment as defined herein. The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. 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).

(xvi) Quotes must be emailed to Louellen.Butler@va.gov and received no later than 12:00 P.M. (NOON) EST on Tuesday, September 24, 2019. Quote may be submitted on this document or the vendor’s own form. Please include Point of Contact name, phone number, and email with response. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Only emailed quotes sent to Louellen.Butler@va.gov will be accepted.

Point of Contact Any questions or concerns regarding this solicitation should be submitted in writing to the Contracting Officer, via email to Louellen.Butler@va.gov.

End of Document End of Document

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