6505--New Radioactive Isotope Contract B+4

Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. The Department of Veterans Affairs, Network Contracting Office NCO20 is currently conducting a market survey to locate qualified firms capable of fulfilling a brand name or equal requirement for dental utility room products. No formal solicitation document exists at this present time. This is not a solicitation announcement. Items listed in this requirement; See attached spreadsheet, SOW, salient specs & QASP. ** The Veterans Health Administration prohibits the use of gray market items in their Medical Centers. Gray market items are considered to be items outside of the original equipment manufacturer s intended distribution channels. Those capable of providing these services should submit a statement regarding their capability on a document containing the official company letterhead. Additionally, those interested and capable shall be authorized

distributors, provide a designated point of contact, the business Unique Entity Identifier (UEI), and the business socioeconomic status in their response to this posting. The North American Industry Classification Systems (NAICS) is 325412. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/ socioeconomic statuses relative to NAICS 325412. Responses to this notice will be used by the Government to make appropriate acquisition decisions. Responses should include company/individual name, a service capability statement, examples of similar facilities for which you have provided services to, UEI number, address, point of contact and social-economic category (ex: SBVOSB, VOSB, 8(a), HUBZone, WOSB, EDWOSB, Small Business). If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be VERIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). Contractor must be registered in System for Award Management (SAM), (see internet site: http://www.sam.gov). Responses to this notice must be submitted in writing via email to Robert.Giard@va.gov and must be received not later than January 31, 2023 15:00PM PST. No telephone inquiries will be accepted. STATEMENT OF WORK (SOW) 1. Contract Title. Production and Delivery of Radioactive Isotopes for Nuclear Medicine examinations at the Mann-Grandstaff VAMC (MGVAMC) 2. Background. Nuclear medicine imaging is an incontestable vital tool for diagnosis, it provides in non-invasive manner the internal structure of the body to detect eventually diseases or abnormalities tissues. Radioisotopes are an essential part of medical diagnostic procedures. In combination with imaging devices which register the gamma rays emitted from within, they can be used for imaging to study the Physiologic processes taking place in various parts of the body. In using radiopharmaceuticals for diagnosis, a radioactive dose is given to the patient and the activity in the organ can then be studied either as a two- dimensional picture or, using tomography, as a three-dimensional picture. Diagnostic techniques in nuclear medicine use radioactive tracers which emit gamma rays from within the body. These tracers are generally short-lived isotopes linked to chemical compounds which permit specific physiological processes to be scrutinized. They can be given by injection, inhalation, or orally. The MGVAMC conducts approximately 2,000 Nuclear medicine examinations annually. The offeror shall be required to deliver in accordance with Table 1 located in Section 4(e) due to the radioactive isotopes decaying rather quickly and dosage (mCi) is vital for high quality diagnostic imaging of patients. The MGVAMC has been using Cardinal Health for approximately 22 years since inception of Nuclear Medicine department at the MGVAMC. The Mann-Grandstaff VAMC currently utilizes SYNtrac software DOSE tracking software. This is Propriety software exclusive to Cardinal Health customers. This dose tracking software enables the VA to pull any data regarding the patient dose received for their examinations data quickly. The old practice of keeping paper records of radioactive material and patient doses is no longer an option, the VA is pushing to move away from paper log- books and requiring electronic records. By the Mann-Grandstaff implementing a software program that will compile this data. The Nuclear Medicine departments at Mann-Grandstaff VAMC s will be following new VA policies along with (TJC) Joint Commission and (NHPP) National Health Physics Program. This monitoring software will work side by side with Cardinal Health, the supplier of our radioactive materials by doses delivered to both VA s, and the doses that the patient receives. 3. Scope. Contractor will provide Radiopharmaceutical products as listed herein, as requested by authorized MGVAMC Staff in support of its mission at 4815 N Assembly St., Spokane, WA 99205. All radiopharmaceutical supplies provided under this contractor will be delivered F.O.B destination to the MGVAMC and not be subject to fuel surcharges. All radiopharmaceuticals provided shall be USDA and USP approved. 4. Specific Tasks. A Contractor shall furnish and deliver radiopharmaceutical supplies as listed on the attached spreadsheet, F.O.B. Destination, to MGVAMC. The dosages must be within plus (+) or minus (-) 10% of mCi ordered. ABBREVIATIONS: Tc: Technetium Xe: Xenon Ga: Gallium I: Iodine NEN: New England Nuclear MDP: Methylene diphosphonate MAA: Macro aggregated albumin DTPA: Diethyltrimethylpentacidic acid DMSA: Dimercaptosuccinic acid HAS: Human Serum Albumin HMPAO: Hexamethylpropylene amine oxime MAG3: Mertiatide In: Indium P: Phosphorus Tl: Thallium Contractor will provide for the placement of up to (3) telephone delivery order (s) per day for items listed in the attached Pricing and Cost spreadsheet, 24 hours per day, seven days a week, including holidays. Offer to complete: 24-hour ordering office: VAMC SPOKANE: CONTRACTOR: ___________________________ ADDRESS: ________________________________ CITY/STATE: _____________________________ 24-HOUR PHONE NUMBER: _______________________________ Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of current licenses and certifications along with quote to the Contracting Officer. Contractor shall provide on an as-needed basis miscellaneous supplies and/or services including but not limited to the following: OSHA compliant monitoring devices. Sealed sources for QA procedures. Dose Calibrator calibration. Annual calibration of survey meters. RSO safety audits for Federal compliance. DELIVERY ORDERS: Normally orders shall be placed during the workday and delivery shall be required by 0700 am the following workday. Due to the demands of the Medical Center patient care requirements, there shall be no restriction to the number of orders which may be placed by VA. In the event that the requirements may be determined in advance, a longer delivery time will be scheduled accordingly. The delivery order shall specify contract item (s) and quantity, time (s) of delivery and applicable VA order number. Orders can be placed orally by telephone and/or fax transmission. Contractor shall routinely provide three (3) deliveries per day. Any additional deliveries will be subject to the emergency delivery fee. The following Table shows Time in Minutes of Decay that would make Isotopes Non-Diagnostic. Delivery requirement is based in minutes of need. Table1 UNIT DOSE ITEMS: These items are to be provided on a unit dose bases, as specified, pre-drawn into a syringe, calibrated, and delivered to the VA on date and time specified when the order is placed. ITEM NO Item Description Est. QTY Unit Time in Minutes of Decay 1 Tc99m-MDP (20-30mCi/dose) 151 EA 120 Min 2 Tc99m-MAA (5mCi/dose) 10 EA 60 Min 3 Tc99m Choletec (10mCi/dose) 40 EA 60 Min 4 Tc99m DTPA (20mCi/dose) Aerosol 7 EA 60 Min 5 Tc99m Sulfur Colloid (10mCi/dose) 34 EA 60 Min 6 Tc99m Sestamibi Cardiolite (30-40mCi/dose) 5 EA 90 Min 7 Tc9m Mag3 11 EA 60 Min 8 Tc99M Sestamibi Cardiolite (generic) 2042 EA 90 Min MULTIDOSE TC99M Products ITEM NO Item Description Est. QTY Unit Time in Minutes of Decay 1 Tc99m Pertechnetate (40mCi/dose) 25 EA 60 Min 2 Tc99m Pertechnatate (10mCi/dose) 17 EA 60 Min 3 Tc99m Perechnate Bulk MD 0 EA 60 Min NONRADIOACTIVE NUCLEAR PHARMACEUTICALS COLD KITS : ITEM NO Item Description Est. QTY Unit Time in Minutes of Decay 1 Ultratag RBC Labeling kit 21 EA 60 Min SOFTWARE: The Mann-Grandstaff VAMC requires Dose Tracking Software. Dose tracking software enables the VA to pull any data regarding patient dose received for their examinations quickly. The Mann- Grandstaff VAMC currently uses SYNtrac software which is proprietary software through Cardinal Health. Contractor must provide isotopes that are/able to be used with Cardinal Health SYNtrac software. Software must include the following Characteristics: Cradle to grave radioactive materials management (RAM) of patient doses, sealed sources, and any other radioactive materials we use for quality management testing. Keeps track of all patient doses and displays when we exceed 10 or 20 percent of the requested dose. Provides a variety of report form formats (such as pdf, etc.) for incoming and outgoing RAM packages. Does record keeping of Daily surveys, channel constancy checks, accuracy, linearity, etc. Must be capable of presenting in a report form format (such as pdf, etc.) for daily, weekly or monthly review. Allows the user to create reports that the department needs to evaluate or measure different patient parameters. Provides a method to create a backup for all data entered regarding patients or radioactive materials use. Must have edit capabilities, when something has been entered incorrectly. User must be able to add new Radiopharmaceuticals or sealed sources as the department needs evolve. Allows reports to be printed for review or document filing. DELIVERY LOCATION: Deliveries will be made to: MGVAMC: Mann-Grandstaff VA Medical Center Attn: Nuclear Medicine Department Hot Lab, Room A 237-1 Building One, Second Floor 4815 N Assembly St. Spokane WA 99205 Access to this room during non-business hours shall be obtained by contacting VA Police and escorted to hot lab for deliveries. At no time will the vendor have a key or access to the hot lab un-escorted. EMERGENCY ORDERING PROCEDURES: An added cost is provided in line-item G for additional deliveries more than three (3) per day. Depending upon the availability of the product, the Contractor shall make deliveries within 120 minutes when orders are placed between the hours of 07:00 am and 16:30 p.m. and within 2 Â1⁄2 hours when orders are placed between the hours of 16:31 p.m. and 06:59 am. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone order shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. All deliveries must be in approved lead-tungsten alloy shielding pigs, and cases. Any delivered that are not is approved pigs will be sent back to the contractor at no charge to MGVAMC. All invoices should be routed through the government payment process and billed to the correct purchase order for which that month s billing cycle. Any incorrect billing statement will be rejected, and contractor will have to re-submit for proper payment. PERSON S AUTHORIZED TO PLACE ORDERS: MGVAMC: The following MGVAMC staff are authorized to place orders under this contract: Chief Radiology Supervisor, Diagnostic Imaging Service Nuclear Medicine Technologist 5. Security Requirements. The contractor will at no time have access to any VA computers, and, or any patient identifying HIPPA data. 6. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). Not applicable 7. Risk Control All clinical specimens should be treated as a radioactive isotope in the event of a spill or leak. An approved spill kit will be used immediately to minimize the risk of exposure to any persons. 8. Place of Performance All work under this contract is to be performed at Mann-Grandstaff VA Medical Center as outlined in Delivery Commitments: Mann-Grandstaff VA Medical Center Attn: Nuclear Medicine Department Hot Lab, Room A 237-1 Building One, Second Floor 4815 N Assembly St. Spokane WA 99205 9. Hours of Work: Requests will be placed daily, if required, for next day delivery during normal working hours of 7:00 am 5:00 pm Monday through Friday excluding Federal Holidays. The eleven holidays observed by the Federal Government are as follows: New Year's Day Martin Luther King Day President's Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Also, any other day declared by the President of the United States to be a national holiday. 10. Period of Performance. Base year June 1, 2023 ending May 31, 2024 plus four (4) Option Years. QUALITY ASSURANCE SURVEILLANCE PLAN For: Medical Services Contract Number: Upon award will enter contract number> Contract Description: Radioactive Isotopes Nuclear Medicine. Contractor s name: (hereafter referred to as the contractor). 1. PURPOSE This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following: What will be monitored. How monitoring will take place. Who will conduct the monitoring? How monitoring efforts and results will be documented. This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government s responsibility to be objective, fair, and consistent in evaluating performance. This QASP is a living document and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities. 2. GOVERNMENT ROLES AND RESPONSIBILITIES The following personnel shall oversee and coordinate surveillance activities. a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor s performance. Assigned CO: Organization or Agency: Department of Veterans Affairs, Office of Logistics b. Contracting Officer s Technical Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government s behalf. Assigned COR: Randall Barkley c. Other Key Government Personnel 3. CONTRACTOR REPRESENTATIVES The following employees of the contractor serve as the contractor s program manager for this contract. a. Program Manager Randall Barkley b. Other Contractor Personnel - Title: 4. PERFORMANCE MEASURES Performance measures are comprised of performance indicators (some characteristic of a deliverable that can be measured) and performance measures (a mark, measure, or benchmark that government personnel use as a point of comparison when evaluating contractor performance). The Government performs surveillance to determine if the contractor exceeds, meets, or does not meet these measures. The Performance Requirements Summary Matrix, paragraph in the Performance Work Statement (PWS), includes performance measures. The Government shall use these measures to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). TASK REQUIRED SERVICE (Performance Requirements) Substandard (Performance Standards) ACCEPTABLE QUALITY LEVEL (AQL) METHOD OF SURVEILLANCE (Quality Assurance) PERCENTAGE REDUCTION IF EXCEED AQL 1 Monthly billing correct rates, dates, and descriptions, Incorrect billing statements. 100% - No deviation allowable. J. 2 NA bill will be rejected. 2 Radioactive Isotopes/ Specimen delivery service delayed (not weather related). First delivery arriving at the facility locations after 07:00 am 100% - No deviation allowable 1. E Any Isotope specimens that fail to show up prior to the initial 0700 am start of the day 3 Radioactive isotopes must be within plus or minus 10% of mCi dosage requested. Radioactive isotopes below 10% mCi of requested dosage. 98% - No deviation allowable 4. A Dosages below will be returned to vendor at no charge to the VAMC. 4 All deliveries must be in approved lead shielding pigs, and cases. Delivery out of lead shielding pig, and or lead lined casings. 100% no deviations allowable J. 1 Dosages will be returned to vendor at no charge to the VAMC. 5. METHODS OF QA SURVEILLANCE Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP. a. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.) Performance Measure 1,2,3,4 b. 100% INSPECTION. (Evaluates all outcomes.) Performance Measures 1,2,3, 4, c. Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.) Performance Measures 1 6. RATINGS Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used: 7. DOCUMENTING PERFORMANCE a. ACCEPTABLE PERFORMANCE The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action. b. UNACCEPTABLE PERFORMANCE When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager. The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor must present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. 18. FREQUENCY OF MEASUREMENT a. Frequency of Measurement. During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed. b. Frequency of Performance Assessment Meetings. The COR shall meet with the contractor annually to assess performance and shall provide a written assessment. _____________________________ Signature Contractor Program Manager _____________________________ Signature Contracting Officer s Technical Representative