A1 - Performance Work Statement - Radiopharmaceuticals.pdf

Attachment 1 Performance Work Statement 36C25724R0056 Page 1 of 15

PERFORMANCE WORK STATEMENT (PWS)

FOR

NUCLEAR MEDICINE SERVICES

RADIOPHARMACEUTICALS AND MEDICATION

IMAGING DEPARTMENT

19 December 2023

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Section I – Description of Services

1.1. Scope

1.1.1. Contractor agrees to provide all needed radiopharmaceuticals as identified as the Essential Medications/Radiopharmaceuticals to the Nuclear Medicine and/or Positron Emission Tomography/Computed Tomography (PET/CT) Sections of the Imaging Service, Central Texas Veterans Health Care System (CTVHCS), on a daily and/or as needed basis, per this PWS.

The Radiopharmaceuticals and medications are listed in the CTVHCS Radiopharmaceuticals Annual Estimated Usage, paragraph 2 (pages 9 – 11).

1.2. Estimated Workload

1.2.1. Delivery of all radiopharmaceuticals and medications necessary for patient care in PET/CT and in the General Nuclear Medicine Service. CTVHCS Radiopharmaceuticals Annual Estimated Usage provides a list and quantities of essential and optional medications that may be delivered per the Deliverables and Acceptance Criteria.

1.3. Requested Services

1.3.1. Deliveries. Routine, add-on routine and emergency/STAT daily deliveries and documentation shall be provided by the Contractor. The contractor shall contact the Contracting Officer Representative (COR) or nuclear medicine representative with any order/delivery concerns.

1.3.1.1 The contractor must deliver routine orders, same day routine orders and same day Emergency/STAT orders consistent with the proposed times throughout the entirety of the contract.

1.3.2. Radiopharmaceuticals. The contractor must acknowledge the different types of patient population the VA treats and understand the importance of supplying different types and volume of radiopharmaceuticals, isotopes, and supplies. Radiopharmacy medication types and availability is necessary for continuous patient care and will be prioritized. The contractor must ensure the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than +10% or -5% at the time of calibration, from the quantities specified.

1.3.2.1 Calibration time for each requested radiopharmaceutical will be specified with each order (call) or will be spelled out in the requirements provided by the CTVHCS Nuclear Medicine service.

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

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

• Tc-99m pertechnetate: Not shorter than twelve (12) hours.

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

• 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.

1.3.3. Non-Highly Enriched Uranium (LEU) Sources. The contractor for the VA radiopharmaceuticals must be able to produce medical grade radioisotopes from preferentially procured non-Highly Enriched Uranium-235 (LEU) sources. In accordance with the VA Memorandum dated January 3, 2014, and signed by Under Secretary for Health, the Department of Veterans (VA) will preferentially procure medical radioisotopes from non-High Enriched Uranium (LEU) sources. A request has been made to VHA by the Interagency Policy Committee of the White House to preferentially procure Technetium-99m (Tc-99m), the primary radioisotope used in medical diagnosis, produced from non-HEU sources. The reason for this request is that transportation and storage of HEU by radioisotope vendors may be a security and nuclear proliferation risk.

Also, the enactment in January 2013 of the American Medical Isotopes Production Act of 2011 supports creation of domestic production with the goal of reducing U.S.

dependence on foreign sources of medical radioisotopes.

1.3.4. Radioactive Waste. All used radioactive waste syringes and/or vials of acceptable radiopharmaceuticals will be transferred back to the contractor. All such radioactive waste shall be returned (picked-up) the next working day. The contractor shall supply the “secure system” for the prevention of biohazard and radioactive contamination of reusable lead container.

1.3.5. Material Safety Data Sheets. The contractor must provide current material safety data sheets (MSDS) in a binder and updates as necessary on all delivered products or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed.

1.3.6. Lead Shielding. Deliveries for CTVHCS-Temple will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards and regulations relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include Department of Transportation (DOT), Department of Energy (DOE), and Nuclear Regulatory Commission (NRC), and/or agreement state licensure. The level of non-fixed contamination on the external surfaces of each package must be in accordance with 49 CFR 173.443 and may not exceed the limits set forth in Table 9 of that standard.

1.3.7. Software. The contractor must provide compatible software to allow for scanning by a barcode reader using the existing “Nuclear Management Information System” software at the CTVHCS.

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1.3.8. Instrument Calibrations. The contractor must provide instrument calibration/testing for dose calibrators, wipe counters, and probe/well. Testing must include Accuracy, Geometry, Linearity, and annual or as needed calibrations.

1.4. Quality Control (QC)

1.4.1. The objective of QC is to ensure that the medication or radiopharmaceutical passes all required testing to ensure that it is a quality product and safe for patient use.

The contractor shall perform all QC’s IAW the manufacturer/governing body specifications, the approved QC instructions, and schedule.

1.4.2. QC Instructions. Using applicable manufacturer’s specifications, standard industry practices and this PWS, the contractor must test all products for Quality Control and only those products that pass quality control may be sent to the CTVHCS. This testing shall be performed at no additional cost to the VA. The contractor will provide a detailed description of the test upon request.

1.4.2.1. The contractor must provide a copy of their laboratory’s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture.

1.4.2.2. In the event that a quality control or material defect is suspected and/or detected by any CTVHCS staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the CTVHCS Radiation Safety Office, the Contracting Officer Representative (COR) for the contract will notify the contractor and request the contractor to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

• Provide technical expertise in calibration.

• Provide professional examination of product; submit results and recommendations to the Contacting Officer.

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

1.5. Radiopharmacy Permit/Certifications

1.5.1. The contractor shall hold a current unrevoked US Nuclear Regulatory Commission (NRC) and /or agreement state Radioactive Material License (RAM) and applicable Food and Drug Administration (FDA) license to produce and distribute radiopharmaceuticals for human administration, and applicable RAM license to receive, and dispose of radioactive waste.

1.5.2. Contractor shall immediately notify the CTVHCS Nuclear Medicine Service upon any action by the NRC and/or FDA to suspend or modify the contractor’s license.

1.6. Radiopharmaceutical/Medication Evaluations

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1.6.1. The contractor shall allow a minimum 10% radioisotope returns for all contracted radiopharmaceuticals due to patient cancellation, no show, and/or rescheduling at no cost to the facility. In addition, the contractor shall accept returns for full credit toward future orders under the following conditions:

• Product(s) ordered or shipped in error.

• Product(s) damaged in shipment

• Concealed shipping damages

• Recalled product(s)

• Outdated products in unopened, original container.

1.6.2. Upon request by CTVHCS/Radiation Safety Officer, the contractor shall provide a copy/reports of contractor’s Radiation Safety Officer (RSO) Safety Audits of Federal Compliance.

1.7. Authorizations for Access

1.7.1. The contractor will provide updated lists of delivery personnel who will sign in with CTVHCS-Temple Nuclear Medicine Service staff upon each delivery of radiotracer and follow all relevant policies and procedures in place at CTVHCS facilities/Nuclear Medicine Service. Compliance with all applicable regulatory bodies, including FDA and TX/US DOT is required.

1.7.2. Delivery personnel must be escorted at all times within facility ‘Controlled areas’/Nuclear Medicine Service, as per Joint Commission and NRC/regulatory requirements.

1.8. Deliverables and Acceptance Criteria

1.8.1. The contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below:

1.8.1.2. All general nuclear medicine orders will be delivered directly to the CTVHCS- Temple Nuclear Medicine Service, Rm 1A158. All PET isotopes will be delivered directly to the PET/CT Modular Building, Bldg. 200. A Technologist will be at both locations to receive the materials requested.

1.8.1.3. All orders shall be placed by authorized VA personnel during VA normal business hours throughout the workday. The contractor will be furnished the name(s) of VA personnel that are authorized to place orders against the contract and will provide appropriate personnel and contact information for staff receiving orders, able to offer technical or administrative support, as well as staff involved in radiopharmaceutical delivery in accordance with VA Radiation Safety Office requirements. Calls for items in Delivery Orders shall only be placed by authorized CTVHCS Nuclear Medicine Service personnel via telephone, fax, e-mail, or via an approved, secure, online ordering system. For electronic ordering systems, a closed-loop communication process such as confirmation e-mails is preferred.

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1.8.1.4. Deliveries: Depending upon changing Medical Center/Facility patient care requirements, the contractor may be required to provide routine delivery and pick-up, multiple times (>3 times) throughout the day.

Delivery orders, or the electronic ordering system, shall include the following:

• Contract item(s) and quantity

• Time(s) of delivery

• Applicable VA purchase order number must always be identified for current contract.

1.8.1.5. The contractor must ensure prompt ‘add-on same day’ delivery times due to the decay properties of radioactivity. Delivery times must be provided before the contract is awarded to ensure patient and facility needs are met: (Specify time from telephonic order receipt to delivered to facility)

• Routine order delivery time:

• Emergency/STAT order deliver time:

1.8.1.6. The contractor will deliver 1st run at 6:30 AM. First run deliveries that arrive after 7:00 AM will be considered late. Late deliveries will delay patient care and possibly result in the need to reschedule. Doses that cannot be used, due to decay or rescheduling, will be credited and/or replaced. If the dose is replaced, there will be no delivery fee and will not be counted as a scheduled delivery.

1.8.1.7 The contractor will ensure that all shipments will have a packing slip enclosed, giving information about the product and its identification, plus (for billing purposes) the CTVHCS obligation number issued for the current contract period, and possibly the contractor’s invoice number. (Incorrect obligation numbers may cause a substantial delay in payments.)

1.8.1.8. The contractor must understand the limitations of the Nuclear Medicine Service at CTVHCS due to USP Guidelines and Radiation Safety in regard to storage and making radioactive kits for multiple use: Deliveries must only contain unit dose orders placed by authorized VA personnel.

• Multi-use radioactive kits/vials are not authorized

• Doses for ‘possible add-on patients’ and/or bulk doses are not authorized

1.9. Hours of Operation

1.9.1. Normal operating days and hours for this requirement are Monday through Friday, from 6:30 AM to 4:00 PM. These dates exclude Federal Holidays, facility closures due to inclement weather, and Furlough Days, as applicable.

1.10. Special Qualifications

1.14. Contractor Personnel

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1.14.1. The contractor shall provide the name of the Contract Manager (CM) and any alternate(s) who shall act for the contractor when the manager is absent, and they shall be designated in writing to the CO and COR within five (5) business days after contract award. The contractor shall provide telephone numbers and email addresses of the CM and alternate(s) where these persons may be contacted at any time. The CM and any designated alternates shall have authority to provide necessary assets (i.e., information, personnel, or equipment, etc.) in order to respond to emergencies and contingencies.

The CM or alternate shall have full authority to act for the contractor on all matters relating to operation of this contract at CTVHCS. The CM or alternate shall be available to meet on the CTVHCS installation with VA personnel designated by the CO to discuss problem areas. The contractor shall provide a CM who can read, write, speak, and understand English fluently.

1.14.2. The contractor and contractor personnel shall be required to identify themselves as contractor personnel by introducing themselves or being introduced as contractor personnel and displaying distinguishing badges or other visible identification for meetings with CTVHCS personnel. The contractor and contractor personnel shall identify themselves as contractor employees in telephone conversations and in formal and informal written correspondence.

1.15. Listing of Contractor Employees

1.15.1. The contractor shall provide an initial listing of contractor employees’ names and position titles to the COR within five (5) business days after contract award. The contractor shall also provide an updated listing of personnel to the COR when employees affecting the work of this contract, status changes or position changes within five (5) business days.

1.15.2. The contractor shall not employ persons on this contract if such employee is identified to the contractor as a potential threat to the health, safety, security and/or general well-being of the installation and its population. The contractor shall be prohibited from employing off-duty CORs who are providing surveillance on any contracts/subcontracts awarded to the contractor. All contractor personnel, depending on particular conditions, occasions, or place or job assignment, shall require professional, suitable attire. All contractor personnel shall conduct themselves in a professional, courteous manner. The contractor shall employ and maintain a technically trained and experienced work force.

1.16. Environmental Protection & Safety

1.16.1. The contractor shall be knowledgeable of and comply with all applicable federal, state, and local laws, regulations, instructions and requirements regarding radiation safety, environmental protection and occupational safety and health. The contractor shall comply with any laws, instructions, or regulation changes during the term of the contract.

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1.16.2. Radioactive Waste. The contractor shall dispose of acceptable radioactive waste syringes and/or vials. The contractor shall notify the COR of any such radioactivity deemed ‘unacceptable for return’ within five (5) business days after the contract is awarded.

1.17. Privately Owned Motor Vehicles (POV)

1.17.1. Contractor personnel shall comply with the directives pertaining to operation of POVs on CTVHCS Motor Vehicle Traffic. The contractor shall comply with CTVHCS (in its entirety) for the operation of POVs within CTVHCS.

1.18. Health and Safety on Government Installations

1.18.1. While performing work under this contract on CTVHCS installation, the contractor shall comply with federal, state, and local regulations and CTVHCS Occupational Safety Instructions. The contractor shall notify the CO of damage to government property or equipment during the execution of the contract.

1.19. Emergency Procedures

1.19.1. Contractor personnel shall follow the directions of CTVHCS personnel with regards to emergency procedures (i.e., fire, tornado, active shooter, bomb threats, etc.).

It is the responsibility of the contractor to provide guidance and establish procedures for responding to an emergency for their employees. It is the contractor’s responsibility to account for their employees following an emergency situation.

1.20. Contractor Billing/Invoicing

1.20.1. The contractor shall follow all CO guidelines for billing/invoicing through Tungsten and must include current PO on all invoices. The contractor shall provide billing/invoicing monthly, from the 1st of the month through the last day of the month. All billing/invoice statements must also include an itemized listing of all items delivered per day.

1.20.2. All billing/invoices must also be sent to the COR for approval.

1.21. Term of Contract

1.21.1. The contract period of performance will be:

• Base: Sep 18, 2024 through Sep 17, 2025.

• Option Year 1: Sep 18, 2025 through Sep 17, 2026.

• Option Year 2: Sep 18, 2026 through Sep 17, 2027.

• Option Year 3: Sep 18, 2027 through Sep 17, 2028.

• Option Year 4: Sep 18, 2028 through Sep 17, 2029.

1.21.2. The contract is subject to the availability of VA funds.

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2. CTVHCS Radiopharmaceuticals Annual Estimated Usage

UOM = Unit of measure (~Annual) Med Amount = radioactive measurement/amount

Essential Medications/Radiopharmaceuticals:

Item Product Description UOM Med Amount

1 Tc99m MAA 15 1 - 7 mCi

2 Tc99m MDP 20 1 - 25 mCi

3 Tc99m Sulfur Colloid 10 1 - 10 mCi

4 Tc99m Filtered Sulfur Colloid 10 up to 3 mCi

5 Tc99m NaTc04 (Bulk Tech) 200 1 mCi

6 Tc99m Ceretec® WBC 4 per study

7 Tc99m Mebrofenin 15 1 - 10 mCi

8 Tc99m MAG-3™ 5 1 - 15 mCi

9 Tc99m Sestamibi 5 1 - 30 mCi

10 Tc99m NaTc04 (unit dose) 5 1 - 30 mCi

11 In-111 Labeled WBC 4 per study

12 NaI I-123 Cap 200uCi 30 200 uCi

13 I-131 Compounded Therapy Capsule 45 1st mCi

14 I-131 Compounded Therapy Capsule -1 600 each add'lt

15 Tl-201 Chloride 30 per mCi

16 Xe-133 Gas 20 20 mCi

17 F18 FDG 1600 1-20 mCi

18 F18 NaFL 30 1-10 mCi

19 Tc99m Myoview® 200 1 - 30 mCi

20 XENON MASK CONV KIT NUMBER: NMC504 40 ea

21 UltraTag 30 1 Vial

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22 ACD/Hetastarch 5 each

23 FDG Calibration Source 5 N/A

24 WBC Collection Kit 7 each

25 In-111 DTPA 1 1.5 mCi

26 In-111 Oxine 4 1 mCi

27 Tc99m MAA Non-HEU 30 1 - 7 mCi

28 Tc99m MDP Non-HEU 90 1 - 25 mCi

29 Tc99m Sulfur Colloid Non-HEU 60 1 - 10 mCi

30 Tc99m Filtered Sulfur Colloid Non-HEU 35 up to 3 mCi

31 Tc99m NaTc04 (Bulk Tech) Non-HEU 1800 1 mCi

32 Tc99m Mebrofenin Non-HEU 35 1 - 10 mCi

33 Tc99m MAG-3™ Non-HEU 5 1 - 15 mCi

34 Tc99m Sestamibi Non-HEU 40 1 - 30 mCi

35 Tc99m NaTc04 (unit dose) Non-HEU 35 1 - 30 mCi

36 Tc99m Myoview® Non-HEU 1500 1 - 30 mCi

OPTIONAL Medications/Radiopharmaceuticals:

Item Product Description UOM Med Amount

37 I-123 DaTscan 60 5 mCi

39 Cu-64 DOTATATE 1 1-10 mCi

40 Ga-68 PSMA 145 1-10 mCi

41 F18 Fluciclovine (Axumin) 1 1-10 mCi

42 Rb-82 0 N/A

43 Ga-68 DOTATATE 12 1-10 mCi

44 Lu-177 DOTATATE 0 N/A

45 F18 PYL 12

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46 Kinevac (CCK) 60 1 Via

Quality Control and Calibrations:

Item Product Description UOM

47 DC Accuracy 3

48 DC Geometry 3

49 Uptake Probe Calibrations 2

50 Wipe Counter Calibrations 2

The contractor is encouraged to identify any additional or alternate items they can provide during the contract term, including new to market products and radiotracers that may provide a contingency source for other CTVHCS Nuclear Medicine Service modalities.

3. Performance Standards

Performance standards define the desired services outcome. 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 acceptable performance threshold.

Performance Requirements Services Summary Matrix:

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SS

ID PERFORMANCE OBJECTIVE PWS

PARA.

PERFORMANCE

THRESHOLD

Deliveries. Routine, add-on routine and emergency/STAT daily deliveries and documentation shall be provided by the contractor. The contractor shall contact the Contracting Officer Representative (COR) or nuclear medicine representative order/delivery concerns. The contractor must adhere to delivery times for routine orders, same day routine orders, and same day Emergency/STAT orders, and maintain those times throughout the entirety of the contract.

1.3.1.

1.3.1.1.

100% Compliance

Radiopharmaceuticals. Types of medication and amount available must be priority. The contractor must ensure the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than +10% or -5% at the time of calibration, from the quantities specified.

Calibration time for each requested radiopharmaceutical will be specified with each order or will be spelled out in the requirements provided by the CTVHCS Nuclear Medicine service. The expiration date and time shall be indicated and affixed to each product as noted below; in general:

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

Tc-99m pertechnetate: Not shorter than twelve

(12) hours.

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

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.

1.3.2.

1.3.2.1.

1.3.2.2.

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Non-Highly Enriched Uranium (LEU) Sources.

The contractor for the VA radiopharmaceuticals must be able to produce medical grade radioisotopes from preferentially procured non- Highly Enriched Uranium-235 (LEU) sources. In accordance with the VA Memorandum dated January 3, 2014, and signed by Under Secretary for Health, the Department of Veterans (VA) will preferentially procure medical radioisotopes from non-High Enriched Uranium (LEU) sources. A request has been made to VHA by the Interagency Policy Committee of the White House to preferentially procure Technetium-99m (Tc-99m), the primary radioisotope used in medical diagnosis, produced from non-HEU sources. The reason for this request is that transportation and storage of HEU by radioisotope vendors may be a security and nuclear proliferation risk. Also, the enactment in January 2013 of the American Medical Isotopes Production Act of 2011 supports creation of domestic production with the goal of reducing U.S. dependence on foreign sources of medical radioisotopes.

1.3.3.

Radioactive Waste. All used radioactive waste syringes and/or vials of acceptable radiopharmaceuticals will be transferred back to the contractor. All such radioactive waste shall be returned (picked-up) the next working day.

The contractor shall supply the “secure system” for the prevention of biohazard and radioactive contamination of reusable lead container.

1.3.4. 100%

Material Safety Data Sheets. The contractor must provide current material safety data sheets (MSDS) in a binder, and updates as necessary, on all delivered products, or the contractor must provide a website link where the MSDS and package inserts for all radiopharmaceuticals provided can be read and printed.

1.3.5.

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Lead Shielding. Deliveries to the CTVHCS will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards and regulations relating to shipment of radioactive materials.

Shipping containers must comply with all federal and state regulations. This will include Department of Transportation (DOT), Department of Energy (DOE), and Nuclear Regulatory Commission (NRC), and/or agreement state licensure. The level of non-fixed contamination on the external surfaces of each package must be in accordance with 49 CFR 173.443 and may not exceed the limits set forth in Table 9 of that standard.

1.3.6.

Software. The contractor must provide compatible software to allow for scanning by a barcode reader using the existing “Nuclear Management Information System” software at the CTVHCS.

1.3.7. 100%

Instrument Calibrations. The contractor must provide instrument calibration/testing for dose calibrators, wipe counters, and probe/well.

Testing must include Accuracy, Geometry, Linearity, and annual or as needed calibrations.

1.3.8. 100%

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QC Instructions. Using applicable manufacturer’s specifications, standard industry practices and this PWS, the contractor must test all products for Quality Control and only those products that pass quality control may be sent to the CTVHCS. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

The contractor must provide a copy of their laboratory’s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture.

In the event that a quality control or material defect is suspected and/or detected by any CTVHCS staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the CTVHCS Radiation Safety Office, the Contracting Officer’s Representative (COR) for this contract will notify the contractor and request the contractor to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

Provide technical expertise in calibration.

Provide professional examination of product;

submit results and recommendations to the Contacting Officer.

Make expedient replacement of any product suspected of being deficient.

1.4.1.

1.4.2.1.

1.4.2.2.

The contractor shall hold a current unrevoked US Nuclear Regulatory Commission (NRC) and /or agreement state Radioactive Material License (RAM) and applicable Food and Drug Administration (FDA) license to produce and distribute radiopharmaceuticals for human administration, and applicable RAM license to receive, and dispose of radioactive waste.

1.5.1. 100%