36C24818Q0835-001.docx

Performance Work Statement Y-90 SIR-Sphere Radiopharmaceuticals

1.0. Introduction.

1.1 The Government requires Y-90 SIR-sphere radiopharmaceutical in support of the Miami VA Medical Center, Nuclear Medicine Section of Imaging Service.

2.0. Description / Scope / Objective.

The Contractor must provide all labor, equipment, tools, material, supervision and other items and services necessary to perform the work as defined in this Performance Work Statement.

3.0. Applicable Documents.

3.1. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

VHA

Handbook 1200.06, Control of Hazardous Agents in VA Research Laboratories.

3.2. Glossary: Acronyms used in this PWS are listed below for easy reference:

4.0 Performance Requirements.

4.1 The contractor shall supply to the Government Y-90 SIR-sphere radiopharmaceuticals in support of the Nuclear Medicine Section and Interventional Radiology Section in accordance with any and all medical/legal or otherwise doctrine for the safe and effective use thereof for intended medical diagnosis and procedures.

4.1. The contractor shall abide by (CFR 10) Title Code of Federal Regulations.

4.1.1. A License may be used for medical use only by product material manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulation in Title 10, Code of federal Regulations, Part 35 and the equivalent regulations of an Agreement State.

4.1.2. Reagent kits that have been manufactured, labeled, packed and distributed in accordance with the approval by the Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

4.2. Contractor agrees to provide prepared Y-90 SIR-sphere radiopharmaceutical and associated materials to the Government as ordered and at the agreed upon price.

4.3. Contractor shall have available an adequate supply of contract products to meet the requirements of the Government.

4.4. Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date.

4.5. Contractor shall follow USP standards for radiopharmaceutical manufacturing when applicable. Certificate of analysis shall be provided when requested.

4.6. All packing of radioactive materials MUST BE clearly labeled RADIOACTIVE on the outside of the shipping carton and comply with all applicable regulating agencies. The Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

4.7. Contractor shall provide user training support to start the program.

4.8. Contractor shall accept returns for credit under certain conditions. Some conditions include but are not limited to:

4.8.1. Product(s) shipped in error.

4.8.2. Product(s) damaged in shipment.

4.8.3. Concealed shipping damages.

4.8.4. Recalled product(s).

4.8.5. Outdated products in unopened, original container (specifically authorized for return by manufacturer).

4.9.6. The contractor shall provide return goods authorization and packaging as well as instructions at no cost to the Government within 48 hours after receiving notification that it has product to be returned.

4.10. Contractor shall submit certified invoices monthly. Invoices at a minimum shall show period covered, billing, name of preparation, items, quantity, and amount.

5.0. Performance Location and Hours.

5.1. Location(s): Contractor will deliver product(s) to:

Bruce W. Carter Center, MVAHS 1201 NW 16th. Street, Third Floor Room D311, PET/CT Suite Miami, Florida 33125

5.2. Hours: Based on the unique characteristic of Y-90 SIR-sphere agent, the Miami VA Healthcare System will coordinate with vendor to meet available delivery times.

6.0. Deliverables.

6.1. The items listed in the price/cost schedule shall be delivered to the Miami VAHS, 1201 NW 16th Street, Room D311.

6.2. Deliverables: Any and all deliverables shall be received at the convenience of the Government. The Government reserves the right to cancel, or not accept delivery at any time. The contractor shall bear any and all expenses of items not received.

6.2.1. Orders shall include: contract item product name; dispensed and ordered amount; volume; calibration time; and applicable prescription number.

6.2.2. Orders can be placed by the Government via telephone or fax.

6.2.3. The Governments point of contacts will be provided upon request.

6.2.4. Delivery specified by the Government shall be FOB destination within consignee’s premises. A clear description of the date and time an item is due to be received shall be provided by the contractor.

7.0. Key Personnel Replacement and Substitution.

7.1. Requests for approval of substitutions shall be in writing and shall provide a detailed explanation of the circumstances necessitating the proposed substitutions. The request shall contain a complete resume for the proposed substitute, and any other information requested or required by the Contracting Officer to approve or disapprove the request. Proposed substitutes shall have qualifications that are equal to or higher than the personnel being augmented. The Contracting Officer or his/her authorized representative shall evaluate such requests and promptly notify the Contractor in writing whether the proposed substitution is acceptable.

7.2. If the Contracting Officer determines that, (1) suitable and timely replacement of personnel who have been reassigned, terminated or have otherwise become unavailable for the contract work is not reasonably forthcoming, or (2) the resultant substitution would be so substantial as to impair the successful completion of the contract or the delivery order in accordance with the proposal accepted by the Government at time of contract award, the Contracting Officer may, (1) terminate the contract for default or for the convenience of the Government, as appropriate, or (2) at his discretion, if he finds the Contractor at fault for the condition, equitably adjust the contract price downward to compensate the Government for any resultant delay, loss or damage.

7.3. Contractor shall replace any absent individual for any period greater than one workday (may be changed) so as to leave a full complement of trained qualified personnel at all times with no disruption of services.

8.0. Contractor Personnel and Management.

8.1. Contractor Personnel. The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

8.2. Contractor Badges. Contractor personnel shall also wear a laminated contractor identification badge at all times if on the Miami VA premises when performing services under this Contract. The badge will contain a personal picture, name of employee, and Contractor's name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard.

8.3. Safety/Security Requirements. Contractor shall comply with all applicable federal, state and local laws and ensure performance is secure while protecting material, equipment, and supplies from damage and loss. Government security personnel shall have the express right to inspect for security violations at any time during the term of the contract.

8.4. All information generated in performance of this contract becomes property of the Government and must be surrendered upon request and/or completion of the contract. The Contractor must protect against the destruction and/or misplacement of all information produced under this contract, unless directed under local policy to destroy. This includes both hard and soft copies of data.

8.5. Contractor shall not release any information (including photographs, files, public announcements, statements, denials, or confirmations) on any part of the subject matter of this contract or any phase of any program hereunder without the prior written approval of the COR.

8.6. Standards of conduct

8.6.1. Conduct of Personnel. Contractor personnel shall conduct themselves in a professional manner (i.e. timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of the Government. The hospital director or designated representative has the authority to bar individuals from the Government facility. The removal from the job site or dismissal from the premises shall not relieve the Contractor of the requirement to provide sufficient personnel to perform the services as required by this performance work statement. The Government shall not reimburse the Contractor for travel and other expenses associated with the removal of personnel.

8.6.2. Contractor personnel are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract.

8.6.3. Working Attire and Appearance. Contractor personnel shall present a professional appearance commensurate with standards delineated for Government civilian personnel acting in similar capacities.

9.0. TRAVEL: NOT APPLICABLE.

10.0 NON-PERSONAL SERVICE STATEMENT.

10.1. Contractor employees performing services under this order will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in the PWS. Contractor employees will perform their duties independent of, and without the supervision of, any Government official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

11. PERSONNEL QUALIFICATIONS.

11.1. Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the PWS in an efficient, reliable, and professional manner.

11.2. Specific Personnel Qualifications Requirements –Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum:

11.2.1. Be able to work in the United States.

11.2.2. Possess DOT and Hazardous Material training if required by their duties.

12.0 PERFORMANCE STANDARDS AND QUALITY MEASUREMENT.

12.1. Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the AQL. The QASP method of surveillance will be by random inspection.

12.2 The QASP and its performance objectives are as follows:

Standard

4.4

5.2