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Page 1 of 22 1. SCOPE It is the intent of VISN 2 North to establish a Blanket Purchase Agreement (BPA) contract that will provide Quality Control Materials and software for testing performed by VISN 2... Page 1 of 22 1. SCOPE It is the intent of VISN 2 North to establish a Blanket Purchase Agreement (BPA) contract that will provide Quality Control Materials and software for testing performed by VISN 2 North laboratories that includes but is not limited to the test list in the Price Schedule below. Any facility in VISN 2 North may, in the future, purchase quality control material for any other product listed on the vendor s FSS schedule at the posted CPT rate only after a warranted Contracting Officer issues a modification to the BPA to add the new items. 2. DESCRIPTION The VA agrees to: ALBANY: Use of real time software compatible with Data Innovations Instrument Manager, quality control materials for all tests indicated in the volumes section of this RFQ. BUFFALO: Use of real time software compatible with Data Innovations Instrument Manager, quality control materials for all tests indicated in the volumes section of this RFQ. SYRACUSE: Use of real time software compatible with Data Innovations Instrument Manager, quality control materials for all tests indicated in the volumes section of this RFQ. BATH: Use of real time software compatible with Data Innovations Instrument Manager, quality control materials for all tests indicated in the volumes section of this RFQ. CANANDAIGUA: Use of real time software compatible with Data Innovations Instrument Manager, quality control materials for all tests indicated in the volumes section of this RFQ. This BPA will serve as the commitment for the Albany, Buffalo, Syracuse, Bath and Canandaigua Medical Centers. 3. GENERAL REQUIREMENTS Provide full service in accordance with the Performance Work Statement (PWS) and the following: Provide Quality Control Software that shall have the following characteristics: Compatible with Data Innovations Instrument Manager. Ability to provide real time, online peer group statistics with peer review and qc report capability for national and VISN 2 North peer groups. Levy Jennings graphing and Westgard rules capability. Six Sigma graphing and analysis User defined parameters to assist with auto-verification of test results. Moving averages. Ability to incorporate third party controls such as analyzer reagent kit controls. Customizable to each site. Ability to hold patient test results if quality controls are unacceptable or haven t been run in the last 24 hours. W7 compatibility and hardware/software functionality for direct network connectivity. Vendor responsible for any licensing or hardware used to connect to Data Innovations/network. Any connections from the software back to the vendor will follow VA guidelines and must be FIPS 140-2 and CRISP compliant. Provide QC Material for the tests listed below with lot outdates of at least one year. Provide QC Material with a minimum open bottle stability of five days. Include a list of QC Material with listed analytes and outdates of the QC material for each analyte if different from the open bottle stability. Provide QC Material lot sequestering with the ability for VISN 2 North sites to be on the same lots of QC Material. Ability for VISN 2 North sites to form their own peer group and receive peer group statistics and qc reports in addition to national/international peer groups statistics and reports. Ability to automatically sequester new lot numbers with the longest outdates when the current sequesters run out without intervention from the VISN. All Software upgrades shall be provided at no additional cost to VA and as they become available. Any hardware components, if applicable, shall be provided at no additional cost to VA All hardware upgrades shall be provided at no additional cos to VA as they become available. Hard drives, if necessary, shall be removed and turned over to VA for destruction at the completion of the contract or replacement of a hard drive. Online ordering capabilities via email or website. Vendor shall replace any QC material damaged in shipping or that arrives outside the appropriate temperature range within 24 hours at no additional cost to the VA. Provide electronic copies of operators manuals, procedures, and chemical safety data sheets. Vendor must have an ISO/MOU security agreement and current Business agreement with the VA. Vendor must provide training for all applicable staff on the use of the software. WARRANTY PROVISION The VA acknowledges the following Warranty Provision: Government warranty applies per FAR 52.212-4 (o) and (p) contained in the solicitation. ORDERS All products ordered under the awarded Blanket Purchase Agreement (BPA) are subject to the terms and conditions of the awarded Agreement. The awarded BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders issued under the Delivery Orders and Purchase Orders by the Contracting Officer Representatives (COR s) as assigned. PRICING As this is a Commercial Item Request for Quotation (RFQ), which must contain technical proposals as well as pricing, if the pricing schedule is not in line with your commercial practice, you may provide alternate pricing. Additionally, provisions of more than one proposal are acceptable if you are proposing an alternate solution to our requirements that has not been expressed in this solicitation. Please use the data provided below in Exhibits A in order to determine Cost Per Test (CPT) pricing. ITEMS TO BE ORDERED UNDER THIS BPA: COST PER REPORTABLE TESTS AT A CONSOLIDATED PRICE PROVIDE TABLE OF PRICE GROUPINGS AND IMMUNOASSAY KIT PRICING BELOW: EXHIBIT A: Laboratory Tests for Fiscal Year 2022 A1AT Ceruloplasmin Gentamicin LDL Direct Acetaminophen Chloride GGT LH AFP Cholesterol Glucose Lipase Albumin CK Haptoglobin Lithium Alcohol CKMB HDL Magnesium Alkaline Phosphatase Cocaine Hemoglobin A1c Methadone Ammonia Cortisol Hepatitis A IgM Microalbumin Amphetamines Covid Antibody, Total Hepatitis A Total Microglobulin, Beta-2 Amylase Covid Antibody, IgG Hepatitis B Core Ab Opiates Barbiturates C-Reactive Protein Hepatitis B Surface Ab Osmolality, serum & urine Benzodiazepines Creatinine Hepatitis B Surface Ag Oxycodone B-HCG Cystatin C Hepatitis C PCP B-Hydroxybutyrate Digoxin High Sensitivity Troponin Phenobarbital BNP Direct Bilirubin HIV 1 Phenytoin BUN Estradiol HIV 2 Potassium Buprenorphine Ferritin IgA Pre-Albumin C3 Folate IgG Procalcitonin C4 Free Kappa Light Chains IgM Prolactin Calcium Free Lambda Light Chains Inorganic Phosphate PTH Intact Cannabinoids Free T3 Iron Rheumatoid Factor Carbamazepine Free T4 Lactic Acid Salicylates Carbon Dioxide FSH LDH SGOT (AST) SGPT (ALT) TIBC Transferrin Uric Acid SHBG Total Bilirubin Triglycerides Valproic Acid Sodium Total Protein TSH Vancomycin Testosterone TPSA Urine/CSF Protein Vitamin B12 Theophylline Triiodothyronine Urine Fentanyl Vitamin D The table above provides the tests performed within VISN 2 Facilities for fiscal year 2022. Every test is not performed at each facility. PERIOD OF PERFORMANCE: This BPA expires 60 months from the date the analyzers are placed in use for patient testing. The maximum term of this BPA shall be five (5) years from the date the analyzers are placed in use for patient testing of this BPA which shall consist of one (1) base period and four (4) option years. A review of the BPA will be done annually IAW 8.405-3(e). The VA will review the estimated purchases and the corresponding discounts for this BPA annually. The maximum term of this BPA pursuant to FAR 52.217-8 is five years. The VA will review the estimated purchases and the corresponding discounts for this BPA annually ORDERING INFORMATION The following information specifies authorized ordering personnel, order format, and delivery. 8.1. The following VA employees are hereby authorized to place orders under this BPA: Albany: Lisa Hewson, 518-626-5766 Eltaib Abdellah 518-626-5765 Nicole Vartigian 518-626-5765 Bath: Robin Duryea, 607-664-4421 Sandra Ahmed, 607-664-4424 Buffalo: Paula Barblock, 716-862-8718 Julie Bauer, 716-834-9200 Susan Stanko, 716-862-8710 Canandaigua: Brett Eaker 585-393-7152 Syracuse: Jennifer Garuccio, 315-425-6525 Lisa Beattie, 315-425-6525 Christine Slate, 315-425-3775 8.2 Orders will be placed against the BPA using E-mail, Electronic Data Interchange (EDI), FAX, paper, or oral communications. 8.3 Deliver all items ordered under this BPA to: Albany: Stratton VA Medical Center Attn: Chemistry Laboratory, B301 113 Holland Avenue Albany, NY 12208 Bath: Bath VA Medical Center Attention: Pathology & Laboratory Medicine 76 Veteran s Ave. c/o Warehouse Bldg. 103 Bath, NY 14810 Buffalo: VA Western New York Healthcare System P&LM (113) Attention: Core Lab 2B 3495 Bailey Avenue Buffalo, NY 14215 Canandaigua: Canandaigua VA Medical Center Attention: Pathology & Laboratory Medicine 400 Fort Hill Avenue Canandaigua, NY 14424 Syracuse: Syracuse VA Medical Center Attention: Pathology & Laboratory Medicine 800 Irving Avenue, Syracuse, NY 13210 9. INVOICING Unless otherwise agreed to, all deliveries under this BPA must be accomplished by delivery tickets or sales slips that contain the following information at a minimum: - Contractor name; - BPA number and any delivery/task order number assigned under the BPA; - Purchase Order Number; - Date of purchase; - Date of shipment; - Description of each item, including (when applicable) model number and Special Item Number (SIN); - Quantity for each item in the order; - Unit price and extended (quantity x unit price) price for each item. Send invoices to the address specified in each task/delivery order. 10. REPORTS The Contractor shall submit to Contracting Officer total combined purchase of reagents on a quarterly basis. The report shall be submitted by email no later than the 21st calendar day of each quarter. A summary report shall be submitted to the Contracting Officer Representative at least monthly or upon expiration of this BPA, whichever occurs first, of all deliveries made during that period, identifying the delivery tickets covered therein and supported by receipt copies of the delivery tickets. This report is solely for the purpose of confirming reagent inventory and receiving records. 11. ALL OTHER TERMS AND CONDITIONS: The terms and conditions included in this BPA apply to all orders placed against it. 12. TERMINATION: Either party to this agreement may terminate this agreement upon 90 calendar days written notice delivered to the addresses below. 13. MINIMUM ORDER REQUIREMENTS: N/A 14. EVALUATION--COMMERCIAL ITEMS The Government will award a 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. Technical and past performance, when combined, are approximately equal to price. Written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award The following factors shall be used to evaluate offers: Technical Technical abilities/characteristics. All of the following requirements must be addressed to be considered responsive. Capability of providing quality control material for the list of required tests provided in Exhibit A. Clearly identify any test NOT able to be included. Clearly identify the number and types of quality control material available, to include serum/plasma, urine, body fluids, and cerebrospinal fluid. QC stability for unopened and opened bottles. If stability varies by test for a given quality control material, clearly identify the stabilities for each test within the quality control material. State the ability of proposed software to hold results if Quality Controls have not been run in more than 24 hours or results are unacceptable. Capabilities of the Quality Control Software. Compatible with Data Innovations Instrument Manager, Levy Jennings graphing capability, Westgard rules capability, Sigma analysis capability. Moving averages, Ability to incorporate third party controls such as analyzer reagent kit controls. Services provided by Contractor. Assist with the installation and set-up of the Quality Control Software including connectivity to each applicable assay system at each site. Turnaround time for orders. Orders shall take no more than 48 hours to be processed and shipped. Ability to sequester the same lots for all VISN 2 North sites and establish a mini-peer group for the VISN including automatic sequester of new lots of control material for the VISN based on the usage of the individual site. Ability to provide real time, online peer group statistics with peer review and qc report capability for national and VISN 2 North peer groups. Ability to provide online ordering. Provide each site with monthly lot sequester reports that clearly state the amount remaining for each lot and the lot expiration dates. Price Past Performance Identify all Federal, State, and local government contracts and private contracts of similar type, scope, size, and complexity that are ongoing, or have been completed in the past three (3) years. Provide a list of references pertaining to those contracts. Information to be provided must include that evidences customer satisfaction with an offeror s products and services and demonstrates an offeror s compliance with and fulfillment of the requirements of previous contracts. 15. CONTRACT AWARD MEETING The Contractor shall not commence performance on the tasks in this PWS until the CO has conducted a kickoff meeting or has advised the contractor that a kickoff meeting is waived. 16. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) The QASP is a short format understanding of the requirements under this contract and how the VA will review the Contractor s meeting of the contractual requirements. 16.1. Task Order Title: VISN 2 North Quality Control Blanket Purchase Agreement 16.2. Work Requirements: Are broken down into the two following sets: 16.2.1: Technical Requirements Task 1 - Accurate Testing Task 2 Long outdates on lots Task 3 - Lot to Lot Uniformity in Controls Task 4 QC Software capabilities 16.2.2: Service Requirements  Task 1 Lot Sequestering Task 2 Prompt fulfillment of orders Task 3 Limit need for tech support 16.3 Primary Method of Surveillance 16.3.1 Technical Requirements One Hundred Percent (100%) Inspection will be required for Tasks 1 and 2. This will be accomplished by quality controls review and proficiency testing surveys. Random sampling will be used for Task 3 under Technical Requirements. Customer input will be used for Task 4. 16.3.2 Service Requirements: Tasks 1, 2, and 3, the method of surveillance will be random sampling and customer input.  16.4 Performance Standards:  16.4.1 Technical Requirements Task 1: Technical Requirements: Initial setup of QC software to include interface with Data Innovations Instrument Manager and establishment of connectivity with each analyzer. Task 2: Lot to lot uniformity across VISN 2 North for quality controls. 100% of each control should fall within established Coefficient of Variation appropriate to each analyte. Task 3: Training performed on-site for software package; Ninety percent (90%) of users trained can perform at the eighty-five percent (85%) level after initial training. 16.4.2 Service Requirements Task 1: 99% of orders are filled within 48 hours of being placed. Task 2: 99% of orders will arrive at the ordering facility within the specified temperature range.  16.5 Surveillance Method: 16.5.1 Technical Requirements Tasks 1 and 2, Surveillance will be conducted through quality control review and proficiency testing surveys. Task 3: Section Supervisors will review all staff and their competency on qc software and report findings to Laboratory Managers and PLMS Chiefs. Supervisors will conduct surveys of PLMS staff to review effectiveness of training. 16.5.2 Service Requirements Task 1, 2 and 3: Review and trend analysis of order logs and inventory reports. 16.6 PROCEDURES 16.6.1 The Inspection Procedure Inspection for Tasks 1 and 2 of the performance work statement will be performed as each reportable result is validated by the Chief of each Service. The Coefficient of Variation appropriate to each analyte shall be the baseline for inspection. All other tasks in the technical and performance requirements will be inspected monthly and unresolved outliers reported to the Chief of Service. 16.6.2 The Sampling Procedure Sampling of all effected tests will be performed for Tasks 1 and 2. Documentation of received equipment and other instrumentation, service calls, and response time will be the sampling procedure for all other tasks listed in technical and performance requirements. 16.6.3 Variations: The allowed variations are noted in the performance work statement. Additional variations can be allowed after discussion between the Contractor and the VA. 16.6.4 Lot Size: The lot size will vary. Actual numbers cannot be expressed as this is related to the number of unique analyte tests performed. 16.6.5 Sample Size: The sample size is the same as the lot size for one hundred percent (100%) inspection. For random sampling, sample size is usually calculated using standard statistical techniques.