FBODaily.com | FedBizOpps: FILE | 66 | VISN 15 Chemistry CPRR with Instrumentation and Automation - Attachment

FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 13, 2016 FBO #5438
DOCUMENT

66 -- VISN 15 Chemistry CPRR with Instrumentation and Automation - Attachment

Notice Date: 10/11/2016
Notice Type: Attachment
NAICS: 325413 — In-Vitro Diagnostic Substance Manufacturing
Contracting Office: Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street Trafficway;Leavenworth KS 66048
ZIP Code: 66048
Solicitation Number: VA25517N0016
Response Due: 10/18/2016
Archive Date: 11/17/2016
Point of Contact: Capps, Penny Penny.Capps2@va.gov
E-Mail Address: penny.capps2@va.gov
(Penny.Capps2@va.gov)
Small Business Set-Aside: Total Small Business
Description: STATEMENT OF WORK - Clinical Laboratory Chemistry Immunochemistry Instrumentation 1. BPA LANGUAGE 1.1. INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN (15) to establish a Blanket Purchase Agreement (BPA) for Automated Chemistry Immunochemistry Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/ Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The Government will award a CPRR BPA to a single Contractor for Automated Chemistry Immunochemistry Instrumentation and automation to support workflow. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment/herein and awarded in the final BPA. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract. 1.2. ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals. 1.3. PRICES AND TERMS: VISN 15 will provide an estimated volume by test as reflected in Attachment A, Tab C for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A Tab C, but does not guarantee volumes as listed; they are estimates ONLY. 1.4. TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA with one base year and four, one year options and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor's FSS contract. In addition, where a new FSS contract replaces Contractor's current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN AAA intends to establish the base year of the agreement for the period of 7/1/2017 through 6/30/2018. 1.5IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity; VA255-17-Q-0003. 1.6ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. 1.7 DELIVERY TERMS: The delivery terms for all items ordered under the BPA will be FOB Origen. Contractor will make shipping arrangements and prepay all shipping and handling costs. Contractor will promptly replace all Products lost or damaged in shipment. Contractor will be responsible for all disputes with the shipper and all insurance claims related to the shipment. 2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 2.1. SCOPE OF PROCUREMENT: 2.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). 2.1.2.. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. 2.1.3. If Contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility. 2.1.4. New equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A, Tab B. 2.1.5. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award. 2.1.6. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor's equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the regularly scheduled standing order/routine supplies delivery. 2.1.7. The Contractor is required to provide differing automation levels for sites in VISN 15 based on Attachment A, Tab A. The contractor must provide separate line items for CPRR billing and automation billing. 2.2. DEFINITIONS: 2.2.1. Cost per Patient Reportable Result (CPRR)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor's equipment and necessary for the generation of a patient reportable result. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. 2.2.2. Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor's equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. 2.2.3. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. 2.2.4. Primary Processing Automation Line - Pre-analytical processing equipment offered to each of the VA laboratories listed on Attachment A that will automate the pre-analytical specimen processing functions, as indicated in the general requirements section. 2.2.5. Specimen Management System - A component of the Processing Automation Line that directs and manages the operation and components of the pre-analytical processing/automation system. 2.2.6. Contractor Middleware Management System - For the purposes of this solicitation, this is a separate component or module that electronically connects the testing instrumentation to manage data, results and workflow of 2 or more pieces of instrumentation. (Not to be confused with middleware for interfacing equipment with the hospital/laboratory information system.) 2.2.7. Throughput - The speed that the equipment processes and/or operates reported in units per hour. 2.3. Test Menu - Refer to Attachment A, Tab C Wkld Est for desired test menu and estimated annual volumes by laboratory. 2.4. GENERAL REQUIREMENTS 2.4.1. Primary analyzer(s) - Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer's instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. 2.4.2. Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and be available on the Contractor's FSS Contract at the time of quote submission and have the following: 2.4.2.1. Primary Processing Automation Line Instrumentation. Processing Automation Line Instrumentation for Clinical Laboratory Chemistry/Immunochemistry Instrumentation may be comprised of the following modules: specimen management system, centrifuge, decapper, recapper/sealer, and refrigerated storage which are connected with an automated track or line according to the requirements of each respective laboratory, as listed in Attachment A. See Attachment A, Tab A for specific requirements for each site. 2.4.2.1.1. Documentation provided will be used to determine if automation is feasible within each requesting laboratory. No award for automation will be finalized until all stakeholders at each participating site have signed off on proposed plans. 2.4.2.1.2. Quotes should include a CAD diagram of proposed layout for each participating laboratory. 2.4.2.1.3. Cost structure of the automation line should be separate from CPRR pricing. Provide Pricing for Automation on Attachment A, Tab D, Automation Pricing. 2.4.2.1.4. The Processing Automation Line Instrumentation shall have the following: 2.4.2.1.4.1. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A, Tab C. 2.4.2.1.4.2. Specimen management system to manage and track sample progress and position. 2.4.2.1.4.3. Specimen archival system that maps specimens to racks or refrigerated storage for easy retrieval once moved from the automation line. (Specimen Management System). 2.4.2.1.4.4. The ability, based on test requests, to sort specimens. (Line/Track System/ Specimen Management System) 2.4.2.1.4.5. The ability to connect by a line or track system all primary and back-up testing analyzers offered in accordance with Attachment A (Line/Track System). 2.4.2.1.4.6. The ability to send processed specimens by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. (Line/ Track System / Specimen Management System) 2.4.2.1.4.7. The ability to prioritize STAT specimens. (Specimen Management System) 2.4.2.1.4.7.1. System has random-access capability, with ability to optimize fastest time to completion. 2.4.2.1.4.7.2. Equipment quoted should have the ability to meet a 60 minute turnaround time from sample arrival in laboratory to release of results at least 95% of the time. 2.4.2.1.4.7.3. Routine turnaround time (excluding Community Based Outpatient Clinics) should be completed in less than 60 minutes (Lab Arrival to Result Time) 95% of the time. 2.4.2.1.4.7.4. Contractor agrees to a business review at least once per year to ensure that quality metrics are met. 2.4.2.1.4.8. Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen. (Specimen Management System) 2.4.2.1.4.9. The ability to detect processing errors and provide error notification. (Specimen Management System) 2.4.2.1.4.10. The ability to separate the serum/plasma from the blood cells through the process of centrifugation. (Centrifuge) 2.4.2.1.4.11. The ability to remove the collection caps from a variety of types and sizes of blood collection tubes. (Decapper) 2.4.2.1.4.12. The ability to replace and/or reseal a variety of types and sizes of blood collection tubes. (Recapper/Resealer) 2.4.2.1.4.13. Barcoding stations located at key points along the line or track system must have the following capabilities: 2.4.2.1.4.13.1. A barcode reading accuracy rate of 99% or greater for any component that requires barcode reading. 2.4.2.1.4.13.2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. 2.4.2.1.4.13.3. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and numeric concurrently 2.4.2.1.4.14. The ability to manage inventory of reagents. (Inventory Management) 2.4.2.2. Testing Instrumentation The testing instrumentation must be approved by the Food and Drug Administration (FDA) and be available on the on Contractor's FSS Contract at the time of quote submission and shall have the following: 2.4.2.2.1. The capability of performing analysis on the tests listed in Attachment A, Tab C, Wkld Est. 2.4.2.2.2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A, Tab C. 2.4.2.2.3. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system- 2.4.2.2.3.1. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. 2.4.2.2.3.2. Equipment must accept, at a minimum,10 characters in specimen identifier that is alpha and numeric concurrently that may be enabled concurrently. 2.4.2.2.3.3. A barcode reading accuracy rate of 99% or greater. 2.4.2.2.4. An instrument management system (internal to testing instrumentation) that provides/maintains the following: 2.4.2.2.4.1. Quality Control: 2.4.2.2.4.1.1. On-board QC data management system with minimum storage capacity of 600 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data to BIORAD QC Program or disk storage. 2.4.2.2.4.1.2. Shall provide ability to peer review external comparison data for quality control materials and have inter-laboratory peer comparisons forwarded monthly. Average peer group size shall be sufficient to enable adequate monitoring and comparison of results. A peer group shall be at least 10 peers for an established lot number of quality control. 2.4.2.2.4.1.3. Ability to store quality control values for second lot number during crossover studies. 2.4.2.2.4.1.4. Ability to retain quality control data from second lot number when put into use. 2.4.2.2.4.1.5. The quality control material shall be included in the BPA for all tests in use (credit towards purchase). 2.4.2.2.4.1.6. Contractor shall provide lot number coordination to ship the same lot (minimum suggest outdate for controls lots shall be more than one year). 2.4.2.2.4.1.7. Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor. 2.4.2.2.4.2. Maintenance: 2.4.2.2.4.2.1. Ability to monitor instrument performance. 2.4.2.2.4.2.2. Continuous monitoring of vital instrument functions with immediate operator notification of failure(s). A record(s) of the vital instrument function failure(s) must be maintained and stored electronically on-board the equipment. 2.4.2.2.4.2.3. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. 2.4.2.2.4.2.4. Capability to capture, store and print the following information: 2.4.2.2.4.2.4.1. Instrument maintenance information. 2.4.2.2.4.2.4.2. Patient demographic information. 2.4.2.2.4.2.4.3. Specimen results. 2.4.2.2.4.3. The ability to print patient reports in chartable medical record format for use during downtime operations. 2.4.2.2.5. On board reagent inventory management system must have: 2.4.2.2.5.1. A system that provides reagent data to include but not limited to lot number, expiration date, and the number of remaining tests available for use on the analyzer(per analyte). 2.4.2.2.5.2. Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology. 2.4.2.2.5.3. A barcode reading accuracy rate of 99% or greater. 2.4.2.2.6. Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen. The introduction of a STAT specimen must not compromise existing programmed testing. 2.4.2.2.7. On board reagent stability sufficient to accommodate both high and low volume use. 2.4.2.2.8. The ability to detect and alert operator of low liquid levels and the potential of depletion. 2.4.2.2.9. The ability to unload/remove empty reagent containers from the equipment during operation without interrupting testing in progress. 2.4.2.2.10. The ability to calibrate and support more than one (1) reagent lot of the same reagent on the equipment at the same time. 2.4.2.2.11. The capability to calibrate assays during test run without aborting the run. 2.4.2.2.12. The capabilities to store, print, and retrieve calibration data. 2.4.2.2.13. The ability to continuously load patient specimens. 2.4.2.2.14. The ability to detect short samples. 2.4.2.2.15. The ability to detect and flag for hemolysis, lipemia and icterus. 2.4.2.2.15.1. Hemolysis, icterus and lipemia interference threshold for analytes shall be provided/validated by the manufacturer. 2.4.2.2.15.2. The Government reserves the right to review all quotes based on individual merit and make a medical based decision on the system(s) offering least interference and provides best overall value to the Government. 2.4.2.2.16. The ability to perform testing with limited interference from human anti-mouse or heterophilic antibodies. 2.4.2.2.17. Clot detection with alert notification. 2.4.2.2.18. Primary tube sampling from evacuated collection tubes of various sizes and from various manufacturers. 2.4.2.2.19. Capable of handling all routine sample collection tubes plus other various sized sample containers, e.g. sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts. 2.4.2.2.20. The capability to auto dilute a test when defined limits are exceeded. (Contractor shall indicate on Attachment A, tab F Misc Info each analyte that can be set to auto dilute on each instrument model offered.) 2.4.2.2.21. The capability to program a test to perform a repeat analysis. The repeat test result must be able to cross the interface and overlay the initial result. 2.4.2.2.22. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. 2.4.2.2.23. For those sites requiring back up analyzers, it would be desirable for the backup analyzer to be a mirror image or have the same reagent requirement as the primary analyzer. 2.4.2.2.24. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. 2.4.2.2.25. IDMS traceable Creatinine reagent. 2.4.2.2.26. Minimal requirements for sample pre-treatment. 2.4.2.2.27. Minimal requirements for reagent/calibrator preparation. 2.4.2.2.28. Minimal carryover. 2.4.2.2.29. Long calibration stability. 2.4.2.2.30. The capability of incorporating other manufacturer's reagents. 2.4.3. Reagents: 2.4.3.1. Convenient Reagent and Standard Use. 2.4.3.2. Extended Calibration life for most analytes with little or no daily/weekly calibration. 2.4.3.3. Automatic calibration of electrolytes. Analyzer has the ability to notify user when calibration is within one hour of expiration. 2.4.3.4. Liquid calibrators for most or all tests with minimal calibrator preparation 2.4.3.5. Reagents with little or no reagent preparation for most or all tests. 2.4.3.6. Instrument shall have capability to flag new reagent packs prior to quality control use. 2.4.3.7. Enzyme verifiers available to periodically check performance of enzyme tests that lack standards. 2.4.3.8. Reagents have prolonged shelf life and stability once opened and on board the analyzer. 2.4.3.9. Various reagent sizes to allow economical usage by both small and large laboratories in VISN 15. 2.4.3.10. Offeror shall characterize each method and provide exact vendor guaranteed minimum linearity/AMR, CRR limits in Attachment A, tab F. 2.4.3.11. As new methods are released for the instrument, the updates are automatically enabled promptly and at no cost to user. 2.4.3.12. Offer shall provide AMR Calibrator Values and Calibrator frequency in Attachment A, tab F. 2.4.3.13. Offer shall provide Percent (%) CV on assays in Attachment A, Tab F. 2.4.4. Auto-verification Support - 2.4.4.1. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity through existing Data Innovations Middleware solutions. This collaboration may be accomplished by direct support by the contractor, by a sub contract to a mutually agreed upon secondary vendor or a combination of both. 2.4.4.2. All rules necessary to support auto-verification will be written and tested prior to go live date for the new analyzer configurations. 2.4.4.3. Support will be provided to assist with any issues that are found during the go live process for auto-verification and for at least one month post go live. 2.4.4.4. Analyzers should allow for auto-verification to be accomplished at each VA facility through existing VA owned Data Innovations Middleware solutions. 2.4.5. Contractor Middleware Management System - Automation Line: 2.4.5.1. Sufficient memory to store data requirements for operation of Primary Processing Automation Line. 2.4.5.2. Supports workflow management that supports all integrated (linked) testing instrumentation and Primary Processing Automation Line. 2.4.5.3. Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired automation enhancing productivity and management of workflow. 2.4.6. Hardware Features- The instrumentation shall have the following: 2.4.6.1.1. All monitors/screens will clearly display information in all light conditions. 2.4.6.1.2. A printer(s) that has the capability of printing a patient report with patient demographic information that includes minimally the patient's name and accession or unique identifier number (UID). 2.4.6.1.3. An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. 2.4.7. Specific Equipment Requirements- 2.4.7.1. Patient testing is disabled if QC failure occurs. 2.4.7.2. The technology to allow electronic transmission of quality control data to BIORAD or other Quality Control program through the VA owned Data Innovations Middleware. 2.4.7.3. Equipment relocation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) relocation within each site. 2.4.7.4. Ability to maintain use of the equipment if the Automation Line were to be in an off-line status for service or maintenance. 2.4.7.5. For general chemistry tests, when more than one lot of a given reagent has a valid calibration on the analyzer and quality control material is programmed to run as a control (in the control mode): 2.4.7.5.1. Quality control material will automatically be run on all lots of those reagents when the respective test is requested. 2.4.7.5.2. Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor. 2.4.7.5.3. Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration. 2.4.7.5.4. The ability to run old lots of QC concurrently with new lots for parallel testing. 2.4.7.5.5. Analyzer utilizes windows operating software or other VA approved operating system. Vendor will complete and return the following attachments: 2.4.7.5.5.1. 6550 Pre-Procurement Assessment 2.4.7.5.5.2. MDS2 Manufacturer Disclosure Statement for Medical Device Security 2.4.8. Method Performance/Validation Requirements- 2.4.8.1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids, as applicable. These validation requirements are applicable to all new testing analyzers. 2.4.8.2. Correlation studies for each analyte. A minimum 20 samples spanning the reportable range, shall be run comparing the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI. 2.4.8.3. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. 2.4.8.4. Precision study using normal and abnormal control material. This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal controls. Intra-VISN facility variations should be kept at an absolute minimum. 2.4.8.5. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. 2.4.8.6. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. 2.4.8.7. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge. 2.4.9. Reference Range- A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used: 2.4.9.1. A verification of the manufacturer's suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer's range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification. 2.4.9.2. If the suggested manufacturer's range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method. 2.4.9.3. If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed. 2.4.9.4. Data will be aggregated from each site to determine a VISN reference range. 2.4.10. Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter's business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. These reports will be in an Excel spreadsheet; multiple tabs may be used, to include a VISN summary tab. Attachment A, Tab C Wkld Est Tab may be used as a template to provide these quarterly reports. 2.4.11. Support Features- 2.4.11.1. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, "current production" shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. 2.4.11.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this BPA. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and provide a hard-copy of data in an organized, clearly comprehensible format. 2.4.11.3. Documentation: 2.4.11.3.1. A current editable, electronic (Microsoft Word) copy of the instrument operating guide(s) and procedures shall be provided to each site. 2.4.11.3.2. The document(s) shall be formatted in accordance with current, approved CLSI guidelines. Electronic (CD Format). 2.4.11.3.3. At a minimum, electronic copies of Safety Data Sheets (SDS) shall also be provided. 2.4.11.3.4. Updates to all procedure manuals in Microsoft Word format and SDS sheets in electronic format shall be provided when package inserts are modified. 2.4.11.4. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility's services and minimally equivalent to the terms and conditions for training defined in the Contractor's Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per instrument per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. 2.4.11.5. In addition to the training above the following shall be provided: 2.4.11.5.1. Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable. 2.4.11.6. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization for 2 key operators if middleware is required for automation. If training program involves off-site travel, contractor shall cover the cost of airfare, room and board for each participant. 2.4.11.7. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, etc. offered according to the following terms: 2.4.11.8. Service Requirements 2.4.11.8.1. Preventative maintenance will be performed as frequently as published in manufacturer's operator's manual and within 2 weeks of the scheduled due date. 2.4.11.8.2. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour(s). 2.4.11.8.3. Equipment repair service shall be provided during core business hours. See Attachment A, Tab B defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. 2.4.11.8.4. Equipment repair response time shall be no more than 24 hours. 2.4.11.8.5. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: 2.4.11.8.5.1. date and time notified 2.4.11.8.5.2. date and time of arrival 2.4.11.8.5.3. serial number, type and model number of equipment 2.4.11.8.5.4. time spent for repair, and 2.4.11.8.5.5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 2.4.11.8.6. Each notification for an emergency repair service call shall be treated as a separate and new service call. 2.4.11.8.7. Vendor will supply any needles/probes or supplies necessary to keep the equipment operational. 2.4.11.8.8. If upgrades or changes in technology render a piece of equipment no longer necessary, contractor shall remove said piece at contractor's expense. 2.4.11.9. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of -the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to "system upgrades" that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. 2.4.11.10. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), printers and universal interface equipment, UPS Batteries, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. 2.4.11.11. Interface Requirements- 2.4.11.11.1. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A). 2.4.11.11.2. The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A. 2.4.11.11.3. If a site already has a universal interface system, the Contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. 2.4.11.11.4. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. 2.4.11.11.5. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. 2.4.11.11.6. The Specimen Management system must be computer interface compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. 2.4.11.12. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. 2.4.11.13. Characterization of waste - The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 "Protection of the Environment" Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. 2.4.11.13.1. The determination and description shall address the following: 2.4.11.13.1.1. Waste toxicity (Reference 40 CFR �261.11 and 40 CFR �261.24) 2.4.11.13.1.2. Waste ignitability (Reference 40 CFR �261.21) 2.4.11.13.1.3. Waste corrosivity (Reference 40 CFR �261.22) 2.4.11.13.1.4. Waste reactivity (Reference 40 CFR �261.23) 2.4.11.13.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR �261.31) 2.4.11.13.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR �261.33) 2.4.11.13.1.7. Solid Waste (Reference 40 CFR �261.2) 2.4.11.13.1.8. Exclusions (Reference 40 CFR �261.4) 2.4.11.13.2. The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. 2.4.11.13.3. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR �261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR �261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response: "Barium(Total) "Cadmium(Total) "Chromium(Total) "Copper(Total) "Cyanide(Total) "Lead(Total) "Mercury(Total) "Nickel(Total) "Silver(Total) "Zinc(Total) "Arsenic(Total) "Selenium(Total) "Tin(Total) "pH "Flash point (to higher than 200 �F) "BOD; biochemical oxygen demand 2.4.11.13.4. The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system. 2.4.11.14. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. 2.4.11.14.1. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 120 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. 2.4.11.14.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor's submitted plan shall not exceed 120 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA. 2.4.11.14.3. At the end of 120 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA. 2.4.12. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor's technical specification or as quoted in any quote at an effectiveness level of 90% or more. [reference: Master FSS] 2.4.12.1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. 2.4.12.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled "Termination for cause." (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) 2.4.12.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. 2.4.12.4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. [reference: Master FSS] 2.4.12.5. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. 2.4.12.6. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer's instructions, shall be solely that of the Contractor. [reference: Master FSS] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this BPA, i.e., water system UPS, etc. 2.4.13. Government's Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. 2.4.14. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. 2.4.15. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. 2.4.16. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA. 2.4.17. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the BPA or disposal or return of the IT equipment, whichever is earlier. 2.4.18. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: 2.4.18.1. Contractor must accept the system without the drive; 2.4.18.2. VA's initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or 2.4.18.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 2.4.19. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; 2.4.19.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and 2.4.19.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA. 2.4.19.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25517N0016/listing.html)
Document(s): Attachment; File Name: VA255-17-N-0016 VA255-17-N-0016.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3048915&FileName=VA255-17-N-0016-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3048915&FileName=VA255-17-N-0016-000.docx; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: Department of Veterans Affairs;VISN 15;Multiple Facilies; Zip Code: 64106-2175
Record: SN04301120-W 20161013/161011234114-2c70678c706deb7f3bda0399f58a8be2 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

66 -- VISN 15 Chemistry CPRR with Instrumentation and Automation - Attachment