Draft Statement of Work.pdf

General Information

The VA Salt Lake City Health Care System (VASLCHCS) seeks a Not To Exceed (NTE) base plus four

(4) option year contract for the procurement of unit dose radiopharmaceuticals, radioactive sources, and supplies for diagnostic imaging exams and quality assurance procedures.

Radiopharmaceuticals, or medicinal radio-compounds, are a group of pharmaceutical drugs containing radioactive isotopes. Radiopharmaceuticals can be used as diagnostic and therapeutic agents to diagnose specific pathologies, such as cancer, osteomyelitis, cardiac ischemia, and infection.

The Contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work.

General Requirements

• The Contractor shall have an adequate supply of products to meet the requirements of the VASLCHCS. Contractor must provide a proposed supply chain contingency plan for all proposed line items. This is to ensure continuing and uninterrupted radiological clinical care.

• Due to the required stat low energy unit doses for same day patient orders, contractor shall be located within a reasonable milage so that delivery requirements can be maintained.

• Calibration time for each requested radiopharmaceutical is given in the Schedule of item, 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.

• If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided at the calibration time. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±10%.

• The expiration date and time shall be indicated and affixed to each product. Contractor will use commercially reasonable efforts to achieve identified expiration times.

• If a quality control or material defect is reasonably suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

o Provide technical expertise in calibration.

o Provide credit for any product confirmed to be deficient.

o Provide professional examination of product; submit results and recommendations to the Contracting Officer. In the event product is found to be compliant after examination under this subsection, VASLCHCS shall be responsible for costs associated with the examination.

• The contractor shall provide quality assurance/quality control radioactive sources as needed and during normal working hours.

• The contractor must follow all U.S. Pharmacopeia (USP) 797 and 825 guidelines and provide verification of compliance upon Contracting Officer request.

• All Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state regulations relating to shipment of radioactive materials. Shipping

STATEMENT OF WORK

Radiopharmaceuticals

George E. Wahlen VA Salt Lake City Health Care System

500 Foothill Drive Salt Lake City, UT 84148 containers must comply with all federal and state regulations. This will include but not limited to:

Department of Transportation (DOT), Department of Energy, U.S. Nuclear Regulatory Commission (NRC), and Interstate Commerce Commission (ICC).

• The contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and by a certified nuclear medicine pharmacist.

• Contractor shall establish a fair and competitive return for credit policy for unused radiopharmaceuticals.

• Contractor shall accept returns for credit under the following conditions:

o Product(s) shipped due to Contractor error.

o Product(s) damaged in shipment o Concealed shipping damages o Recalled product(s) o Products that have expired prior to receipt by the VASLCHCS due to no fault of VASLCHCS

• Upon notification of contract award, Contractor will provide, in writing, within ten

(10) days, the following information to the VA Medical Center:

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

o Email address and/or web portal for placing orders, if applicable.

o Contractor’s telephone number and instructions for placing “Emergency” orders after Contractor’s regular work hours, including weekends.

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

o 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 United States Pharmacopeia (USP).

o Should any changes occur in above information during contract performance period, Contractor will provide updates in writing.

• Current package inserts and material safety data sheets (SDS) of all radiopharmaceuticals supplied under this contract will be shipped and/or a digital copy supplied to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts/SDS are made available, these will be sent to the Nuclear Medicine Service at the Salt Lake City VA Medical Center. 500 Foothill Drive, 114N, Salt Lake City, Utah 84148.

• Contractor must perform all quality control procedures as required by Federal and State regulatory agencies and shall make quality control records available to the Salt Lake City VA Medical Center upon written request from the Contracting Officer or Nuclear Medicine/Radiology service. This testing shall be performed at no cost to the VA.

• Contractor must provide patient orientation education videos and/or other appropriate material as deemed necessary by the medical center.

• The contractor shall provide appropriate signs and posters alerting patients, employees, and the public of safety precautions in the handling of radioactive materials.

• Must be in compliance with all applicable NRC, USP, state, local requirements. Contractor shall abide by Title 10 Code of Federal Regulation (CFR), which states:

o A licensee may be used for medical use only.

o Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State.

o Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with the approval by the Commission pursuant to SS32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

• Personnel assigned by Contractor to prepare and provide the products covered by this contract shall be nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist 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 by the VA Facility Director.

• Contractor shall identify a courier, either internal or external, and provide documentation to the VASLCHCS who are to deliver requested products.

Deliverables

Required product deliverables Item # NTE Qty Description/Part Number*

1 900 Tc-99m Sestamibi Unit Dose (UD), 1-30 mCi 2 50 Tc-99m NaTc04 UD, 1-30 mCi 3 1 Tc-99m Bicisate (Neurolite®) UD, 1-30 mCi 4 10 Tc-99m Filtered Sulfur Colloid UD, up to 1 mCi 5 75 Tc-99m Macro Aggregated Albumin (MAA) UD, 1-7 mCi 6 60 Tc-99m Mebrofenin UD, 1-8 mCi 7 125 Tc-99m Medronate UD, 1-25 mCi 8 40 Tc-99m Mertiatide (MAG3) UD, 1-10 mCi 9 45 Tc-99m Oxidronate (HDP) UD, 1-25 mCi 10 1 Tc-99m Pentetate UD (Non-Aerosol)(DTPA), 1-15 mCi 11 10 Tc-99m Pyrophosphate UD, 1-30 mCi 12 75 Tc-99m Sulfur Colloid UD, 1-10 mCi 13 4 Tc-99m Dimercaptosuccini Acid (DMSA) UD 14 1 Tc-99m Exametazime (Ceretec®) WBC's 15 1 Tc-99m Non-HEU Pyrophosphate UD, 1-30 mCi 16 4 Tc-99m Denatured Red Blood Cell (RBC) Suspension 17 4 Tc-99m Denatured RBC Collection Kit 18 1 Ga-67 Gallium Citrate UD 19 1 I-123 Iobenguane Sulfate (MIBG) UD, 1-10 mCi 20 5 I-123 Ioflupane UD, 5 mCi

21 36 I-123 USP NaI 100 µCi Cap 22 8 I-123 USP NaI 200 µCi Cap 23 4 I-131 USP NaI DX Cap mCi (Base), 1-6 mCi 24 4 I-131 USP NaI DX Cap mCi (each addt'l mCi) 25 4 I-131 USP NaI DX Cap µCi 26 4 I-131 USP NaI TX Cap (Base), 1-6 mCi 27 800 I-131 USP NaI TX Cap (each addt'l mCi) 28 1 I-131 USP NaI TX UD (Base), 1-5 mCi 29 200 I-131 USP NaI TX UD (each addt'l mCi) 30 1 In-111 Pentatate SDV/Vial 31 1 In-111 Pentetreotide (Octreoscan®) UD, 1-6 mCi 32 1 In-111 Autologous WBC Suspension, 1-25 mCi 33 6 UltraTag Vial 34 75 Xe-133 Xenon Gas 20 mCi Vial 35 5 Xe-133 Xenon Gas 10 mCi Vial 36 100 Regadenoson Inj. 0.4mg/5ml Syr 37 12 *Tc-99m Tilmanocept (Lymphoseek®), up to 1 mCi 38 20 **Cu-64 Dotatate (DetectNet®)/Equivalent 39 20 **Cu-64 Dotatate (DetectNet®)/Equivalent - Cancellation Fee 40 5 ****Ga-68 Gozetotide (Gozellix®)/Equivalent, (FSS) from 3 to 7 mCi

5 ****Ga-68 Gozetotide (Gozellix®)/Equivalent, (FSS) from 3 to 7 mCi -

Cancellation Fee

Required Services 42 250 Weekday Delivery 1 43 250 Weekday Delivery 2 44 24 Weekday Delivery 3 45 12 Weekday Delivery 4 46 6 Weekday Delivery 5 47 12 Weekend Delivery 1 48 6 Weekend Delivery 2 49 3 Weekend Delivery 3 50 24 After Hours Callout 51 24 After Hours Delivery Charge

52 12 STAT

53 3 WBC After Hours

• Contractor shall provide brand name unit dose syringes of the radiopharmaceuticals or equivalent agents, as outlined in the above table, for diagnostic/therapeutic/quality assurance/control purposes as ordered by the Nuclear Medicine Section. Additionally, the contractor will provide all applicable radiation safety equipment, such as syringe shields and shielded syringe box/carriers.

o Product delivery shall not exceed identified QTY in table above, unless authorized in writing by a VHA contracting representative.

• Contractor shall provide at a minimum, one delivery per day during regular operating hours to Nuclear Medicine Service at Salt Lake City VA. Additional deliveries shall be coordinated on an as needed basis and charged at the agreed upon contract rates.

o Deliver directly to the Nuclear Medicine Service at 500 Foothill Dr. Salt Lake City, UT 84148, room 1E06-1 (Hot Lab) and/or 1E19 (PET Hot Lab) daily quantity of radiopharmaceuticals no later than 8:00AM MST, as requested from the previous day.

o Deliver directly to the Nuclear Medicine Service at 500 Foothill Dr. Salt Lake City, UT 84148, room 1E06-1 and/or 1E19 (PET Hot Lab) any mutually agreed upon quantity of radiopharmaceuticals requested at an agreed upon time or as soon as is reasonably practicable.

Shipments “called when needed” may be requested during regular work hours, as “emergency”, dependent on Contractor hours and availability of radiopharmaceutical doses.

All shipments will have a Packing Slip enclosed, giving information about the product and its identification.

The VA Medical Center’s Purchase Order Number issued for the current fiscal quarter or month, and the Contractor’s invoice number will be provided via monthly notice. (Incorrect P.O. numbers may cause a substantial delay in payments.) The packing slip shall include a bar code that works with the Nuclear Medicine Information System (NMIS) for tracking purposes.

The Contractor shall provide routine weekday (Monday thru Friday) deliveries, excluding holidays, during normal working hours (7:00AM – 16:30PM MST) to the Nuclear Medicine Department at the VASLCHCS no later than 8:00AM; barring any production complications.

• Due to isotope degradation, the contractor shall be able to provide all radiopharmaceuticals at least one (1) to two (2) hours prior to specified calibrated date and time, if not sooner.

Calibrated date and time will be dictated at time of order based off individual clinical need.

Additionally, the following emergency radiopharmaceuticals must be delivered as soon as possible but within a one (1) hour time frame, after order:

o Macro Aggregated Albumin (MAA) o Sodium Pertechnetate and Ultra Tag Kit for GI Bleed o Mebrofenin

• The contractor must be licensed by the State of Utah and hold a current, unrevoked NRC and/or Federal Drug Administration (FDA) license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Contractor shall provide a copy of their Radioactive Material (RAM) license with the solicitation.

- In the event that the awardee has any action taken by the NRC, state, and/or FDA to suspend or revoke any license required by Contractor to perform under this Statement of Work, the awardee shall promptly notify Nuclear Medicine Service at the Salt Lake City VA Medical Center.

• Contractor shall provide proof of Dose Management System that is compatible with the existing hospitals tracking system (Biodose NMIS Ec2) with the solicitation.

Ordering Procedures – Not-to-Exceed (NTE) Products

The Station shall be authorized to order products identified under the resulting Contract on an as-needed basis, based on operational requirements, provided that the cumulative value of all orders does not exceed the established NTE amount for each designated product or product category.

Orders may be placed throughout the contract period, at the Station's discretion, in quantities and at frequencies necessary to support operational needs. All orders shall be subject to the established contract pricing, applicable product-specific NTE limits, and availability of authorized funding.

The Contractor shall accept and fulfill orders placed by authorized Station personnel and shall maintain accurate records of all orders, deliveries, and invoiced amounts against the applicable NTE limits. The Contractor shall monitor cumulative expenditures and notify the Station when ordering activity approaches the authorized NTE threshold.

Under no circumstances shall the Contractor fulfill orders that would cause the cumulative value of products ordered to exceed the applicable NTE limit without prior written authorization from the designated Contracting Officer.

The establishment of an NTE amount does not obligate the Station to purchase the full authorized quantity or expend the total NTE value. The Station shall only be financially responsible for products properly ordered, delivered, and accepted in accordance with the terms and conditions of the Contract.

Any increase to an established NTE limit must be authorized through formal contract modification prior to placing orders that would exceed the existing limitation.

Not-to-Exceed (NTE) Product Invoicing and Tracking Requirements

Not-to-Exceed Amounts

Products designated as Not-to-Exceed (NTE) shall be subject to the maximum authorized expenditure established in the applicable Contract, Statement of Work (SOW), Purchase Order (PO), or other written authorization.

The NTE amount represents the maximum financial obligation of the Customer for the designated product or product category and shall not be construed as a commitment to purchase or expend the full authorized amount.

The Contractor shall not exceed the established NTE amount without prior written approval from the Department of Veteran Affairs Contracting Office.

Invoicing Requirements

Contractor must submit monthly invoices for NTE products based solely on actual quantities delivered and accepted, at the applicable contractually agreed-upon unit prices.

All invoices shall be submitted to the Nuclear Medicine Service.

Each invoice containing NTE products shall separately identify:

• Product description and applicable product identification number or SKU.

• Contract, SOW, or PO reference number.

• Authorized NTE amount associated with the product or product category.

• Quantity invoiced during the applicable billing period.

• Contractual unit price and extended amount.

• Cumulative amount previously invoiced.

• Current invoice amount.

• Remaining available NTE balance.

Invoices shall not include anticipated purchases, undelivered products, or amounts exceeding the remaining authorized NTE balance.

NTE Tracking and Reconciliation

The Contractor shall maintain an accurate and current tracking record for each NTE product or designated NTE product category throughout the term of the Contract.

At a minimum, the tracking record shall identify:

• Original authorized NTE amount.

• Approved adjustments to the NTE amount.

• Revised total authorized NTE amount.

• Cumulative quantities and amounts invoiced.

• Amounts invoiced but not yet paid, where applicable.

• Remaining unbilled and available NTE balance.

• Percentage of the authorized NTE amount utilized.

The Contractor shall reconcile NTE tracking records against submitted invoices and applicable purchase orders to ensure accuracy and prevent duplicate billing or expenditures exceeding authorized limits.

An updated NTE tracking report shall accompany each applicable invoice or be provided at another mutually agreed-upon reporting frequency.

NTE Threshold Notifications

The Contractor shall proactively monitor expenditures against each established NTE amount.

When cumulative invoiced amounts and outstanding authorized commitments reach a high percentage of the applicable NTE limit.

The Contractor shall provide written notification to the Customer identifying the remaining available balance and anticipated future expenditures.

The Contractor shall notify the Customer before accepting additional orders or performing activities that would cause the applicable NTE amount to be exceeded.

Failure to provide notification shall not relieve the Contractor of its obligation to comply with established NTE limits.

Changes to Authorized NTE Amounts

Any increase or modification to an established NTE amount must be approved in writing by the assigned Contracting Officer before the Contractor incurs additional charges.

Verbal authorization, historical purchasing practices, or prior invoice approval shall not constitute authorization to exceed an established NTE limit.

Approved modifications shall be reflected in the Contractor's NTE tracking records and subsequent invoices.

Contract Closeout

Upon completion, expiration, or termination of the applicable Contract, SOW, or PO, the Contractor shall provide a final reconciliation of all NTE products, including total authorized amounts, cumulative invoiced amounts, and any remaining unused balances.

Unused NTE balances shall not be invoiced, carried forward, or transferred to other products or contractual obligations without prior written authorization from the Customer.

Work Hours

The delivery of products provided by this contract shall be furnished by Contractor as available and according to Contractor’s production schedule. Contractor shall not be required to furnish such products on a national holiday or during Contractor’s non-working hours or non-production days

The following Federal legal holidays are observed by this facility:

New Year’s Day January 1

Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in November Veteran’s Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

End of Statement of Work