6505--RE-POST Dayton VA Radiopharmaceuticals (VA-22-00000108) Dayton VA Radiopharmaceuticals (VA-22-00000108)
This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in 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. The Government reserves the right to make no award from this solicitation.A A A This is a request for quote (RFQ),A and the solicitation number isA 36C25021Q1084. The Government anticipates awarding a firm-fixed price contract resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circulars 2021-05, effective 03/10/2021. The associated NAICS Code isA 325412,A Pharmaceutical Preparation Manufacturing. A A The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes fromA allA sources to supply theA Dayton VA Medical Center Radiopharmaceutical Isotopes for patient care. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below.A A All questions and concerns regarding this solicitation shall be directed to the Contracting Officer. Questions must be in writing, sent to Gina P. Crank @ gina.crank@va.gov and received no later than August 24, 2021 by 5PM EST. Quotes are to be provided toA Gina P. Crank, Contracting Officer, via email @A gina.crank@va.gov, no later thanA August 31, 2021, byA 5:00A PMA EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.A A Statement of Work (SOW): STATEMENT OF WORK (SOW) The Dayton VA Medical Center (VAMC), Dayton OH has a requirement for Radiopharmaceutical Isotopes for patient care. The Contractor is to provide Radiopharmaceutical products as listed herein, as requested by authorized VA Staff, in accordance with Public Law 104-262 and 38 USC 8153 in order to support the VAMC, Dayton OH. This requirement will include a Quality Assurance Surveillance Plan (QASP), listed below. DELIVERIES: Deliveries to the Dayton VAMC shall be made to: Dayton VAMC Nuclear Medicine Service Bldg. 330 Room 1C-129 4100 West Third Street Dayton, OH, 45428 Contractor shall provide routine delivery and pick-up of items during the hours of 7:00 a.m. to 4:30 p.m., Monday tough Friday, excluding holidays. During non-business hours, deliveries are to be made tough VA Police Service, and the driver will be escorted to Nuclear Medicine. Orders can be placed via telephone, fax or computer by staff nuclear medicine technologists or physicians assigned to the Nuclear Medicine Service at the VAMC and will indicate the required calibration time. Delivery personnel will be required to display a photo ID badge at all times. All routine deliveries of radiopharmaceuticals, ordered by 4:30 p.m. the previous day, shall be at the VA facility by at least 7:00am the next business day. If a second delivery is required it should be before 10:30 am, ET. All Standing orders shall be delivered as routine. Pre-calibrated doses should not expire within 4 hours of calibration time requested by the Nuclear Medicine Service. Pre-calibrated doses of F-18 and F-18 compounded doses shall not expire within 2 hours of the calibration time. Stat (same day delivery orders during normal business hours: 7:00 a.m. 4:30 p.m.) shall be delivered within two (2) hour of placement of the order. Orders placed after 4:30PM weekdays and on weekends shall be delivered within two (2) hours of placement of the order, 24 hours a day, 7 days a week. The 11 Federal Holidays observed by the Federal Government are: New Year s Day January 1st Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth Day June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11th Thanksgiving Day 4th Thursday in November Cistmas Day December 25th The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission (NRC). All products provided under this contract shall be packaged and shipped in accordance with the requirements of the NRC and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and DOT. All products provided under this contract shall be from an FDA approved source with an available NDC number from the manufacturer. Compliance with all OSHA manufacturing, packaging, and shipping regulations is required. The awardee shall provide a copy of Type A package certification and certificates of DOT and OSHA training for couriers prior to the commencement the contract. The contractor shall guarantee the quality of all radiopharmaceuticals. Quality control shall include percent tag and MO99 breaktough as appropriate. The Contractor shall provide Quality Control on each agent dispensed. The Contractor shall guarantee the quality of all radiopharmaceuticals. Only those products that pass quality control may be sent to the VA. The Contractor shall provide complete documentation on Quality Control results upon request. The contractor shall label all products to indicate the amount of radiopharmaceutical, preparation time, expiration time and date to comply with specific facility requirements. The contractor shall invoice at least once a month to the Nuclear Medicine Service indicating the purchase order number, period covered, billing date, name of preparation, quantity, and dollar amount. Each radiopharmaceutical dose should be identified as a line item on the invoice. The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements shall be received within 48 hours of notification by the VAMC. The Contractor shall provide upon request, documentation of inventory, disposal, and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC). RECALLED AND DEFECTIVE PRODUCTS: The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products. Performance Period will be a 5-year ordering Period from date of award with four, one (1) year Ordering Periods to extend the term of the contract. No Modification will be issued annually, only a Delivery Order will be issued annually. Offers will only be considered from Offerors that are licensed by the Nuclear Regulatory Commission who are regularly established in the business of providing radionuclides as called for in this RFQ. Offerors shall provide copies of licenses and certification in response to this RFQ. Proposal Evaluation and Award This is a competitive Request for Quotations (RFQ) that will be evaluated under FAR Part 12 and Part 13. The Government intends to make one (1) award from this RFQ.A A The Government will award a Firm Fixed Price IDIQ 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 will be used to evaluate offers: Price Past Performance Technical (capability of offer to meet the Government s needs) Offers should be submitted electronically by email on August 31, 2021 NLT 5PM EST to the Contracting Officer @ gina.crank@va.gov Offers should include the following 3 sections to their offers: A completed Cost/Price Schedule filled in below AND complete the attached Excel Spreadsheet for RFQ Line Items to be completed by Contractors Updated . Please don t provide any pricing for 153 Sm Therapy since the pricing is dependent on current Market Pricing. Also please don t add/quote any additional Medications to the below Cost/Price Schedule. Additional Medications can be stated but please don t include them to your pricing. For the purpose of evaluation, the total price, including ordering periods, will be evaluated. Past Performance to include the following information Identify at least 3 recent (within the past 3 years) Federal, State, local Government or private contracts that are similar in size and scope to this requirement. Dollar Value Dates of performance Name of Agency/Facility Point of Contact along with contact information A brief description of the work effort to demonstrate the relationship between the reference contract and the proposed effort Technical description in sufficient detail to allow the Government to ascertain the Offerors capability to meet, in addition to the items listed in the cost/price schedule, the requirements indicated in the SOW and should include at a minimum the following information: Ability to meet the required delivery timeframes. Ability to meet compliance and regulation requirements. Quality control measures. Ability to supply LEU sourced products. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The award will be made to the response most advantageous to the Government 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:" Quoters shall list exception(s) and rationale for the exception(s), if any. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). An Offeror s initial proposal should contain the best terms from a price and technical standpoint. Offerors are reminded that representatives from your company SHALL NOT contact any Dayton VAMC personnel to discuss this RFQ during the solicitation and evaluation process. All questions and concerns regarding this solicitation shall be directed to the Contracting Officer. Questions must be in writing, sent to Gina P. Crank @ gina.crank@va.gov and received no later than August 24, 2021 by 5PM EST. Cost/Price Schedule The quantities listed below are yearly estimates only and do not guarantee that the Government will require the total quantities of each item or limit the Government s ability to exceed the quantities. The contractor is to fill in a price for each line item and a total price. Any proposed substitute items need to be clearly marked as such and which item the substitution is proposed for. ITEM INFORMATION ORDERING BASE PERIOD - 10/1/2021 to 9/30/2022 Item Est. Qty Price Per Dose Total Price 99M TC Sulfur Colloid: .5 to 6 Millicurie 145 99M Tc-MDP: 25 Millicurie 510 99M Tc Mebrofenin: 5 to 10 Millicuries 90 99M TC-MAG-3-unit dose: 2 to 15 Millicurie 160 99M Tc-Tetrofosmin (generic): 10 to 35 millicurie 5000 99M TC MAA : 1 to 6 Millicurie 120 IN-111 Pentetreotide: 2 to 7 Millicurie 5 99M TC04-: 25 Millicurie 1500 99m Tc- Sestamibi (generic): 10 to 35 millicurie 40 99m Tc- White Blood Cell labeling per study, (25 mCi) 5 IN-111 White Blood Cell labeling per study, Labeling and Isotope (0.5 to 1 millicurie) 50 99m TC DTPA: 2 to 60 Millicurie 15 I-123: Iodine Capsule 100 Microcuries 90 ULTRATAG KIT 400 99M Tc-Filtered Sulfur Colloid: 0.5 to 1 Millicurie 50 18F : FDG Fluorodeoxyglucose 10 Millicurie 1300 18F : NaF Sodium Fluoride 10 Millicurie 20 123I: MIBG dose 2 Cold PYP vials 60 Tl-201 3 Millicurie 40 99m Tc PYP 10 99m Tc DMSA 10 153 Sm Therapy (Market Price) TBD $0.00 (TBD BY MARKET PRICE) 131I diagnostic capsule 15 131I Therapeutic capsule 15 131I Therapeutic capsule (each additional mCi) 500 99m Ceretec 5 133XE Xenon gas 20 mCi vial 110 Co-57 10 Millicurie flexible QC source 1 Na-22 100 Microcurie rod QC source 1 Total Ordering Base Period ORDERING PERIOD #1 - 10/1/2022 to 9/30/2023 Item Est. Qty Price Per Dose Total Price 99M TC Sulfur Colloid: .5 to 6 Millicurie 160 99M Tc-MDP: 25 Millicurie 560 99M Tc Mebrofenin: 5 to 10 Millicuries 100 99M TC-MAG-3-unit dose: 2 to 15 Millicurie 175 99M Tc-Tetrofosmin (generic): 10 to 35 millicurie 5200 99M TC MAA : 1 to 6 Millicurie 130 IN-111 Pentetreotide: 2 to 7 Millicurie 5 99M TC04-: 25 Millicurie 1650 99m Tc- Sestamibi (generic): 10 to 35 millicurie 45 99m Tc- White Blood Cell labeling per study, (25 mCi) 7 IN-111 White Blood Cell labeling per study, Labeling and Isotope (0.5 to 1 millicurie) 55 99m TC DTPA: 2 to 60 Millicurie 17 I-123: Iodine Capsule 100 Microcuries 100 ULTRATAG KIT 440 99M Tc-Filtered Sulfur Colloid: 0.5 to 1 Millicurie 55 18F : FDG Fluorodeoxyglucose 10 Millicurie 1430 18F : NaF Sodium Fluoride 10 Millicurie 22 123I: MIBG dose 2 Cold PYP vials 65 Tl-201 3 Millicurie 44 99m Tc PYP 12 99m Tc DMSA 12 153 Sm Therapy (Market Price) TBD $0.00 (TBD BY MARKET PRICE) 131I diagnostic capsule 20 131I Therapeutic capsule 20 131I Therapeutic capsule (each additional mCi) 550 99m Ceretec 5 133XE Xenon gas 20 mCi vial 120 Co-57 10 Millicurie flexible QC source 1 Na-22 100 Microcurie rod QC source 1 Total Ordering Period #1 ORDERING PERIOD #2 - 10/1/2023 to 9/30/2024 Item Est. Qty Price Per Dose Total Price 99M TC Sulfur Colloid: .5 to 6 Millicurie 175 99M Tc-MDP: 25 Millicurie 610 99M Tc Mebrofenin: 5 to 10 Millicuries 110 99M TC-MAG-3-unit dose: 2 to 15 Millicurie 190 99M Tc-Tetrofosmin (generic): 10 to 35 millicurie 5400 99M TC MAA : 1 to 6 Millicurie 145 IN-111 Pentetreotide: 2 to 7 Millicurie 5 99M TC04-: 25 Millicurie 1750 99m Tc- Sestamibi (generic): 10 to 35 millicurie 50 99m Tc- White Blood Cell labeling per study, (25 mCi) 7 IN-111 White Blood Cell labeling per study, Labeling and Isotope (0.5 to 1 millicurie) 60 99m TC DTPA: 2 to 60 Millicurie 20 I-123: Iodine Capsule 100 Microcuries 110 ULTRATAG KIT 485 99M Tc-Filtered Sulfur Colloid: 0.5 to 1 Millicurie 60 18F : FDG Fluorodeoxyglucose 10 Millicurie 1570 18F : NaF Sodium Fluoride 10 Millicurie 25 123I: MIBG dose 2 Cold PYP vials 70 Tl-201 3 Millicurie 45 99m Tc PYP 13 99m Tc DMSA 13 153 Sm Therapy (Market Price) TBD $0.00 (TBD BY MARKET PRICE) 131I diagnostic capsule 22 131I Therapeutic capsule 22 131I Therapeutic capsule (each additional mCi) 600 99m Ceretec 6 133XE Xenon gas 20 mCi vial 130 Co-57 10 Millicurie flexible QC source 1 Na-22 100 Microcurie rod QC source 1 Total Ordering Period #2 Ordering Period #3 - 10/1/2024 to 9/30/2025 Item Est. Qty Price Per Dose Total Price 99M TC Sulfur Colloid: .5 to 6 Millicurie 180 99M Tc-MDP: 25 Millicurie 650 99M Tc Mebrofenin: 5 to 10 Millicuries 120 99M TC-MAG-3-unit dose: 2 to 15 Millicurie 210 99M Tc-Tetrofosmin (generic): 10 to 35 millicurie 5600 99M TC MAA : 1 to 6 Millicurie 160 IN-111 Pentetreotide: 2 to 7 Millicurie 5 99M TC04-: 25 Millicurie 1900 99m Tc- Sestamibi (generic): 10 to 35 millicurie 55 99m Tc- White Blood Cell labeling per study, (25 mCi) 7 IN-111 White Blood Cell labeling per study, Labeling and Isotope (0.5 to 1 millicurie) 65 99m TC DTPA: 2 to 60 Millicurie 22 I-123: Iodine Capsule 100 Microcuries 120 ULTRATAG KIT 520 99M Tc-Filtered Sulfur Colloid: 0.5 to 1 Millicurie 65 18F : FDG Fluorodeoxyglucose 10 Millicurie 1720 18F : NaF Sodium Fluoride 10 Millicurie 27 123I: MIBG dose 2 Cold PYP vials 77 Tl-201 3 Millicurie 45 99m Tc PYP 14 99m Tc DMSA 14 153 Sm Therapy (Market Price) TBD $0.00 (TBD BY MARKET PRICE) 131I diagnostic capsule 24 131I Therapeutic capsule 24 131I Therapeutic capsule (each additional mCi) 660 99m Ceretec 7 133XE Xenon gas 20 mCi vial 145 Co-57 10 Millicurie flexible QC source 1 Na-22 100 Microcurie rod QC source 1 Total Ordering Period #3 Ordering Period #4 - 10/1/2025 to 9/30/2026 Item Est. Qty Price Per Dose Total Price 99M TC Sulfur Colloid: .5 to 6 Millicurie 200 99M Tc-MDP: 25 Millicurie 700 99M Tc Mebrofenin: 5 to 10 Millicuries 132 99M TC-MAG-3-unit dose: 2 to 15 Millicurie 230 99M Tc-Tetrofosmin (generic): 10 to 35 millicurie 5800 99M TC MAA : 1 to 6 Millicurie 175 IN-111 Pentetreotide: 2 to 7 Millicurie 5 99M TC04-: 25 Millicurie 2100 99m Tc- Sestamibi (generic): 10 to 35 millicurie 60 99m Tc- White Blood Cell labeling per study, (25 mCi) 7 IN-111 White Blood Cell labeling per study, Labeling and Isotope (0.5 to 1 millicurie) 70 99m TC DTPA: 2 to 60 Millicurie 24 I-123: Iodine Capsule 100 Microcuries 132 ULTRATAG KIT 570 99M Tc-Filtered Sulfur Colloid: 0.5 to 1 Millicurie 70 18F : FDG Fluorodeoxyglucose 10 Millicurie 1890 18F : NaF Sodium Fluoride 10 Millicurie 30 123I: MIBG dose 2 Cold PYP vials 85 Tl-201 3 Millicurie 45 99m Tc PYP 15 99m Tc DMSA 15 153 Sm Therapy (Market Price) TBD $0.00 (TBD BY MARKET PRICE) 131I diagnostic capsule 26 131I Therapeutic capsule 26 131I Therapeutic capsule (each additional mCi) 720 99m Ceretec 7 133XE Xenon gas 20 mCi vial 160 Co-57 10 Millicurie flexible QC source 1 Na-22 100 Microcurie rod QC source 1 Total Ordering Period #4 The following solicitation provisions apply to this acquisition: FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (JUNE 2020) FAR 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (FEB 2021) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. FAR 52.216-1 TYPE OF CONTRACT (APR 1984)- Firm Fixed Price IDIQ contract resulting from this solicitation. FAR 52.232-2 SERVICE OF PROTEST (SEPT 2006) - Hand-Carried Address: Department of Veterans Affairs, Network Contracting Office 10, 2780 Airport Drive, Suite 340, Columbus, OH 43219 Mailing Address: Department of Veterans Affairs, Network Contracting Office 10, 2780 Airport Drive, Suite 340, Columbus, OH 43219 (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. The following contract clauses apply to this acquisition: FAR 52.212-4, CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (OCT 2018) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract: FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) FAR 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011) FAR 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014) FAR 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011) FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016) FAR 52.216-18 ORDERING (OCT 1995) - Such orders may be issued fromA October 1, 2021A toughA September 30, 2026. FAR 52.216-19 ORDERING LIMITATIONS (OCT 1995) - A (a)A Minimum order. When the Government requires supplies or services covered by this contract in an amount of less thanA 1 % of the total estimated annual amount, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract. A A A A A A (b)A Maximum order. The Contractor is not obligated to honor- A A A A A A A A A A A (1)A Any order for a single item in excess of 1 % of the total estimated annual amount; A A A A A A A A A A A (2)A Any order for a combination of items in excess of 10% over the total estimated annual amount; or A A A A A A A A A A A (3)A A series of orders from the same ordering office withinA 30A days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section. A A A A A A (c)A If this is a requirements contract (i.e.,A includes the Requirements clause at subsectionA 52.216-21A of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section. A A A A A A (d)A Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office withinA 5 days after issuance, with written notice stating the Contractor s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source. FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995) - The contract shall govern the Contractor s and Government s rights and obligations with respect to that order to the same extent as if the order were completed during the contract s effective period;A provided, that the Contractor shall not be required to make any deliveries under this contract afterA September 30, 2026. FAR 52.217-7 OPTION FOR INCREASED QUANITY-SEPARATELY PRICED LINE ITEM (MAR 1989) FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) - The Contracting Officer may exercise the option by written notice to the Contractor withinA 30 days. FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT. (MAR 2000) - (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years. FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) 852.203-70, 852.232-72, 852,233-70, 852.233-71 852.246-71, 852.247-71, 852.270-1 VAAR 852.212-71 GRAY MARKET LANGUAGE (MAY 2016) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Jan 2021 The following subparagraphs of FAR 52.212-5 are applicable: [52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-18, 52.232-19, and 52.232-33.] QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) Medical Services Supply Radiopharmaceuticals in unit doses for the Dayton VAMC Contract Number: TBD Contract Description: This contract is intended to provide Radiopharmaceutical products and delivery services and other items as listed herein the Statement of Work (SOW) and Schedule to Department of Veteran Affairs, Dayton VAMC 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, VISN 10 Contracting Office b. Contracting Officer s 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: Jeffrey Willsey, Director Nuclear Medicine Service, Dayton VAMC c. Other Key Government Personnel John Sahlbom, Lead Nuclear Medicine Technologist, Dayton VAMC 3. CONTRACTOR REPRESENTATIVES The following employees of the contractor serve as the contractor s program manager for this contract. a. Program Manager - b. Other Contractor Personnel - Title: 4. PERFORMANCE STANDARDS Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets, or does not meet these standards. The Performance Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). DELIVERY SCHEDULE: DELIVERY SPECIFIED BY THE GOVERNMENT ON FOB DESTINATION WITHIN CONSIGNEE S PREMISES CONTRACTS ARE THE DATES MATERIAL IS DUE IN, NOT THE SHIPPING DATES. Delivery will be made for the same times indicated in this contract to the following locations under the following conditions: DAYTON VAMC: Deliver to 4100 WEST THIRD STREET, DAYTON, OH 45428, NUCLEAR MEDICINE DEPARMENT, 1ST FLOOR. The first delivery in the morning shall be no later than 07:00 am, ET, Monday-Friday. If a second delivery is required, it shall arrive before 10:30am, ET. Additional on demand deliveries occurring Monday-Friday shall arrive within two (2) hours from the time the phone request was placed. The Contractor shall be required, as deemed necessary by the DAYTON VAMC, to furnish such services as specified, on Federal Holidays and during Non-working hours. All deliveries shall be made within two (2) hours after receipt of order. All charges incurred for delivery shall be included in the fee scheduled, to include fuel surcharges. Vendor shall submit a MONTHLY INVOICE within 15 days after the END OF THE MONTH being billed. Invoice shall be accurate, and pricing MUST match contract price for each line item. Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Incentive/Disincentives Delivery of Radiopharmaceuticals to the DAYTON VAMC 1 Timeliness First delivery before 7:00 am ET and second delivery before 10:30am ET Monday tough Friday 100% Observation Past Performance/More than 2 occurrences per year could lead to not issuing a new Delivery Order STAT deliveries made to the DAYTON VAMC within 2 hours of order 2 Timeliness Dose arrives within 2 hours of phone order 100% Observation Past Performance/More than 2 occurrences per year could lead to not issuing a new Delivery Order Accurate Invoicing for the DAYTON VAMC 3 Timeliness A maximum of two (2) errors per monthly invoice 100% 100% Inspection Past Performance/More than 2 occurrences per year could lead to not issuing a new Delivery Order Doses are dry and damage free and are equipped with tamper-evident/ tamper-resistant safeguards 4 Quality Doses arrive dry and without any evidence of damage or tampering 100% 100% inspection Past Performance/More than 2 occurrences per year could lead to not issuing a new Delivery Order Shielded dose containers and the inner syringe or vial are labeled correctly- at a minimum label should have: Radiopharmaceutical name, Rx number, calibration time, dose amount, patient name (if known) and use by date and time 5 Quality Dose containers and syringes/vials are labelled correctly 2 (two) per year Observation Past Performance/More than 4 occurrences per year could lead to not issuing a new Delivery Order Radiopharmaceuticals will be prepared properly with no impurities resulting from improper compounding of dose and All doses are clear of contaminants (i.e., physical contaminants in any dose) 6 Quality Proper biodistribution 100% Observation Past Performance/More than 2 occurrences per year could lead to not issuing a new Delivery Order 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. DIRECT OBSERVATION. (Can be performed periodically or tough 100% surveillance.) The first daily delivery of Radiopharmaceuticals to the DAYTON VAMC will arrive before 07:00 am ET, and the second delivery shall arrive before 10:30am ET Monday tough Friday. 100% accuracy required. STAT deliveries (to include any stat orders made during normal business hours and outside normal business hours) made to the DAYTON VAMC within 2 hours of order. All stat doses arrive with 2 hours of phone order. 100% accuracy required. 100% INSPECTION. (Evaluates all outcomes.) Accurate Invoicing for the DAYTON VAMC with a limit of two (2) errors per monthly invoice. 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: (See 8 section below) 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. 8. 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. FREQUENCY OF PERFORMANCE ASSESSMENT MEETINGS. The COR shall meet with the contractor semi-annually to assess performance and shall provide a written assessment. _________________________________________________________________________ Signature Contractor Program Manager Date __________________________________________________________________________ Signature Contracting Officer s Representative Date
36C25021Q1084 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 10
8/20/21, 12:58 PM