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SAMDAILY.US - ISSUE OF JULY 18, 2021 SAM #7169
SOLICITATION NOTICE

65 -- PET Rx Radiopharmaceuticals for the Cleveland VAMC

Notice Date

7/16/2021 7:26:25 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
 

ZIP Code

45428
 

Solicitation Number

36C25021Q0840
 

Response Due

8/6/2021 2:00:00 PM
 

Archive Date

11/04/2021
 

Point of Contact

Gina P. Crank, Contracting Officer, Phone: 614-625-1236
 

E-Mail Address

gina.crank@va.gov
(gina.crank@va.gov)
 

Awardee

null
 

Description

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.     This is a request for quote (RFQ), and the solicitation number is 36C25021Q0840. 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 through Federal Acquisition Circulars 2021-05, effective 03/10/2021. The associated NAICS Code is 325412, Pharmaceutical Preparation Manufacturing.     The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from all sources to supply the Cleveland VA Medical Center F18-fluorodeoxyglucose (FDG) and Positron Emission Tomography (PET) Imaging 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.    Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than August 6,  2021, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.    STATEMENT OF WORK (SOW): The VA Northeast Ohio Healthcare System, Cleveland, OH (VA) has a requirement for F18-fluorodeoxyglucose (FDG) and Positron Emission Tomography (PET) Imaging Radiopharmaceutical Isotopes for patient care. The Contractor is to provide Unit Dose 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 VA. This is a competitive Request for Quote (RFQ) that will be evaluated under FAR Part 12 and 13. DELIVERIES: Deliveries to VA shall be made to: VA Northeast Ohio Healthcare System Nuclear Medicine Service Basement, Room BC-470 10701 East Blvd, Mail Code 115(W) Cleveland, OH 44106 Contractor will provide products for routine (non-emergent) and emergent orders (aka Emergencies). Emergencies are requests placed during and outside of regular work hours (Monday through Friday 6:30 am to 4:30 pm) requiring delivery within 120 minutes after receipt of phoned, electronic, or faxed orders during regular work hours. Due to the critical timing needs of both Emergencies the Vendor will provide a documented physical operations address, within a 45-minute drive time (during normal traffic volume), where these will be fulfilled. A within 45-minute drive time location must be maintained throughout the full term of the contract. All routine orders can be fulfilled outside of the 45-minute drive time requirement, as outlined below. 1) DELIVERY and DELIVERY SCHEDULE: Delivery specified by the government are 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 above listed location under the following conditions: The first delivery in the morning shall be no later than 6:30am, ET, Monday-Friday. If a second delivery is required, it shall arrive by 10:30am, ET. Deliveries will be made to the Nuclear Medicine Hot Lab-BC518 for PET radiopharmaceuticals. Access to Nuclear Medicine during non-business hours shall be obtained by contacting VA Police Service. All packaging of radioactive materials SHALL BE clearly labeled RADIOACTIVE on the outside of the shipping carton and comply with all applicable regulating agencies. The Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Additional delivery requests for routine orders for same day delivery shall arrive at an agreed upon time when the request is placed. All charges incurred for routine orders shall be included in the FEE schedule, to include FUEL SURCHARGES. Delivery personnel will be bonded by the contractor. Delivery personnel will wear picture identification while in the medical center. The picture identification will be visible at all times. Contractor shall provide evidence of special driver s licenses required for transporting hazardous materials. Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc. All waste shall be picked up with the next scheduled delivery. All radiopharmaceuticals shall be delivered in properly shielded containers. Shipping containers and their labeling must comply with all federal and state regulations. There will be a mechanism to disinfect the shielded containers (pigs) between uses. Any recalled/incorrectly delivered dose for any reason shall be credited for the full amount. All doses shall be delivered to the Cleveland VAMC with a dose security seal to indicate any tampering. The contractor shall provide a daily packing slip accompanying all dose shipments sent the Nuclear Medicine Service for all orders placed. It is the Contractor s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method. Any doses deemed below standard by the facility shall be credited toward the account. Below standard doses include doses missing appropriate labels, wet or damaged product, product not containing the ordered dose (not within 10 % variance), and other issues that are outside of the generally and widely accepted norms for the industry. The VA will be closed on Federal Holidays. These include: -New Year s Day -Martin Luther King s Birthday -President's Day -Memorial Day -Juneteenth Day -Independence Day -Labor Day -Columbus Day -Veterans Day -Thanksgiving -Christmas Day -Any other day declared a Federal Holiday by the US President. Contractor shall provide any additional technical support deemed necessary by VA for the technical staff, physicians, patient education, etc. All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date. The contractor will calibrate all doses to ensure proper activity within the range of +/- ten (10) percent of the specified ordered dose per specified requirements based on guidelines outlined in 10 CFR Part 35. The contractor shall ensure that all doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist and that all doses will be compounded within required guidelines of the Board of Pharmacy, specifically USP and USP as appropriate. Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided upon request at no additional charge. Consultation service regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge. 2) SCOPE: Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities and types of radiopharmaceuticals may vary based on patient demand. All radiopharmaceuticals and pharmaceuticals or kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable local, state, and federal laws. Vendor is to follow generally accepted standard practices for the industry and regulation for the preparation, transportation, and delivery of Radiopharmaceuticals.  These may include but are not limited to the Society of Nuclear Medicine and Molecular Imaging (SNMMI), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Center for Disease Control (CDC), United States Pharmacopeia (USP), and Joint Commission (JC). Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: a Licensee may use for medical use only: By-product material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and the equivalent regulations of an Agreement State. Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Pre-calibrated doses of F-18 and F-18 compounded doses shall not expire within 2 hours of the calibration time. All doses of 18-FDG shall be supplied in shielded vials that are compatible with Bayer s Intego dose infusion system unless prior approval is obtained. The contractor will maximize the number of doses in each vial in order to limit the number of vials shipped each day to no more than two (2). The Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date, etc., and provide a bar code label to facilitate scanning data into a nuclear medicine information management system. Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug, Rx number and calibration time. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded. The Contractor shall have available an adequate supply of the contract products to meet the requirements of the facility listed above at its distribution points. If the ordered radiopharmaceutical cannot be delivered to the VA when needed due to a supply, production, or other issue, the Contractor will notify the VA as soon as possible to minimize the impact on Veteran care. The Contractor will obtain the needed dose(s) from another source, including another Radiopharmacy, to be delivered as near as possible to the scheduled delivery time, with concurrence of VA. Contractor will work with VA to assist in the implementation of a nuclear medicine laboratory information management software and hardware system. For unforeseen circumstances, the Contractor may only substitute another radiopharmaceutical for the requested one with VA s approval. When this is done, the VA will pay for the lower priced radiopharmaceutical. The Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, Food and Drug Administration (F.D.A), OSHA and all other Federal and State agency rules and regulations (Federal and State). Contractor shall accept returns for credit under the following conditions: Product(s) shipped in error Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated products in unopened, original container (specifically authorized for return by manufacturer) Ordering: Contractor will be furnished the name(s) of individuals authorized to purchase against the Contract. Louis Stokes Cleveland VAMC will provide its own Contracting Officer s Representative (COR). 3) PERSONNEL AUTHORIZED TO PLACE ORDERS: The following personnel are authorized to telephone and/or fax radiopharmaceutical orders: Ordering: Contractor will be furnished the name(s) of individuals authorized to purchase against the Contract. VA will provide its own Contracting Officer s Representative (COR). 4) INVOICING: Contracting Officer s Representative (COR) or appointed representative in writing, shall be provided with a copy of invoice at the end of the month for approval before submission to the Department of Veterans Affairs Financial Services Center for processing. Said invoices will be sent the COR via e-mail and then reviewed for accuracy. The contractor will correct any discrepancies identified within 48 hours. A new invoice will be generated and then sent to the COR before invoice is finalized. Contractor shall be paid monthly, in arrears, upon submission of a properly prepared invoice for services/supplies during the period. Contractor shall submit a monthly invoice within 15 days after the end of the month being billed. The invoice will be accurate and include the contract number, date of services, and an itemized listing of charges for each line item. Invoices shall be submitted electronically to the Department of Veterans Affairs Financial Services Center for processing. Contractor shall submit certified invoices monthly. Invoices at a minimum shall show period covered, billing date, name of radiopharmaceutical, prescription number (Rx number), quantity, date, and cost. All doses shall be listed as a separate line item on the invoice. 5) PERFORMANCE/QUALITY: Doses for other customers of Contractor or not intended to be delivered to VA are not to be delivered to VA. This type of incorrect delivery shall not exceed one per contract Quarter. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per Contract Quarter. All doses shall be labelled correctly. The label on the shielded container will match the label on the syringe or vial. It is the Contractor s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method. Contractor shall provide complete documentation of quality control results upon request. Product information including supplier s source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided at no additional charge. Contractor will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass Quality Control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VA Nuclear Medicine Service. All products are purchased subject to acceptance by the VA, Nuclear Medicine Service. Products that fail to meet Quality Control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicine s Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials. Quality Control criteria include but is not limited to: proper labelling of the shielded container and syringe or vial no visible contaminants in the dose dry, clean shielded containers WBC s orders are to have little to no red blood cell contamination intact, undamaged shipping containers, shielded containers and syringe or vial Scan result (incorrect biodistribution) that indicates a poor tag on the radiopharmaceutical All doses and shipping containers shall be equipped with tamper-evident/tamper-resistant devices. 6) QUALIFICATIONS: Personnel assigned by the contractor to perform the services covered by this contract shall be 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 and approval by VA Facility Director if deemed necessary. 7) MODIFICATION: In accordance with FAR 52.212-4(c), changes may only be made by a written modification which is formally executed by the contractor and the Contracting Officer. 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.   The Government will award a Firm Fixed Price Requirements 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 6, 2021 NLT 5PM EST to the Contracting Officer @ gina.crank@va.gov Offers should include the following 4 sections to their offers: A completed Cost/Price Schedule filled in below or as a separate Excel spreadsheet. 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. Complete Excel Spreadsheet for RFQ Line Items (Spreadsheet attached). 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 Cleveland 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 July 23, 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 VA Cleveland, PET Rx - Solicitation Number 36C25021Q0840       Base Ordering Period 10/01/2021 -09/30/2022       Item Est. Qty Dose Price Total Price 18F : FDG (5 - 15 mCi) 2500   $0.00 18F : NaF (5 - 15 mCi) 50   $0.00 Total Base Ordering Period     $0.00 Ordering Period 1 10/01/2022 - 09/30/2023 Item Est. Qty Dose Price Total Price 18F : FDG (5 - 15 mCi) 2600   $0.00 18F : NaF (5 - 15 mCi) 50   $0.00 Total Ordering Period 1     $0.00 Ordering Period 2 10/01/2023 - 09/30/2024 Item Est. Qty Dose Price Total Price 18F : FDG (5 - 15 mCi) 2700   $0.00 18F : NaF (5 - 15 mCi) 50   $0.00 Total Ordering Period 2     $0.00 Ordering Period 3 10/01/2024 - 09/30/2025 Item Est. Qty Dose Price Total Price 18F : FDG (5 - 15 mCi) 2800   $0.00 18F : NaF (5 - 15 mCi) 50   $0.00 Total Ordering Period 3     $0.00 Ordering Period 4 10/01/2025 - 09/30/2026 Item Est. Qty Dose Price Total Price 18F : FDG (5 - 15 mCi) 2900   $0.00 18F : NaF (5 - 15 mCi) 50   $0.00 Total Ordering Period 4     $0.00 Total 5 Year Ordering Period     $0.00 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 52.232-2 SERVICE OF PROTEST (SEPT 2006) 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) FAR 52.216-19 ORDERING LIMITATIONS (OCT 1995) FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995) FAR 52.217-8 OPTION TO EXTEND SERVICES 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) For: Medical Services Supply Radiopharmaceuticals in unit doses for the Cleveland 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 Assurance Surveillance Plan is for the VA Northeast Ohio Healthcare System in Cleveland, OH (aka VA). 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: Gina P. Crank, Contracting Officer 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: 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 - 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 Requirements 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). Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Incentive/Disincentives Delivery of Radiopharmaceuticals to VA 1 Timeliness First delivery before 6:30 am ET and second delivery (when needed), before 10:30am ET Monday through Friday No more than 2 late deliveries per contract quarter Observation Past Performance/ More than 2 occurrences per year could lead to not issuing a new Delivery Order Emergent deliveries made to VA within 2 hours of order 2 Timeliness Dose arrives within 2 hours of phone order No more than 2 late deliveries per contract quarter Observation Past Performance/ More than 2 occurrences per year could lead to not issuing a new Delivery Order Accurate Invoicing for Louis Stokes Cleveland VAMC 3 Timeliness A maximum of two (2) errors per monthly invoice No more than 2 unresolved errors per contract quarter 100% Inspection Past Performance/ More than 2 occurrences per contract quarter could lead to not issuing a new Delivery Order All doses are clear of contaminants (i.e., physical contaminants in any dose or excessive red blood cells in white blood cell labeling) 4 Quality All doses are free of contaminants No more than 2 unresolved incidents per contract quarter 100% Inspection Past Performance/ More than 2 occurrences per contract quarter could lead to not issuing a new Delivery Order Doses are dry and damage free and are equipped with tamper-evident/ tamper-resistant safeguards 5 Quality Doses arrive dry and without any evidence of damage or tampering No more than 1 incident per contract quarter 100% inspection Past Performance/ More than 1 occurrence per contract quarter 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 6 Quality Dose containers and syringes/vials are labelled correctly No more than 1 incident per contract quarter Observation Past Performance/ More than 1 occurrences per contract quarter could lead to not issuing a new Delivery Order Radiopharmaceuticals will be prepared properly with no impurities resulting from improper compounding of dose 7 Quality Proper biodistribution No more than 1 incident per contract quarter Observation Past Performance/ More than 1 occurrence per contract quarter 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 through 100% surveillance.) The First delivery before 6:30 am ET and second delivery (when needed), before 10:30am ET Monday through Friday 100% INSPECTION. (Evaluates all outcomes.) Accurate Invoicing for Louis Stokes Cleveland 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 theCOR shall document the discussion and place it in the COR file. When the CO 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 has to present this corrective action plan to the CO. 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
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/cfe8d93a7d4748e58ce603b2e08cb8df/view)
 

Place of Performance

Address: Nuclear Medicine Service Basement, Room BC-470 10701 East Blvd, Mail Code 115(W), Cleveland, OH 44106, USA

Zip Code: 44106

Country: USA
 

Record

SN06064630-F 20210718/210716230114 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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