Attachment B ChemistryImmunoassay SOW PRE - 0002.docx

SECTION A

SOLICITATION/CONTRACT FORM CONTINUED

1. IDIQ Administration: All IDIQ administration matters shall be handled by the following individuals:

1. OFFEROR:

1. OFFEROR REMITTANCE ADDRESS: All payments by the Government to the Offeror will be made in accordance with:

[X] 52.232-34, Payment by Electronic Funds Transfer - Other than Central Offeror Registration, or

[ ] 52.232-36, Payment by Third Party

1. INVOICES: Invoices shall be submitted in arrears:

1. GOVERNMENT INVOICE ADDRESS: All invoices from the Offeror shall be submitted electronically to: www.fsc.va.gov/einvoice.asp.

1. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

The above amendment section must be filled-out in the event that an Amendment(s) is sent to the offeror or posted to www.fbo.gov and must be returned with the RFQ package. Failure to acknowledge amendment(s) may constitute the rejection of the offer.

SECTION B

1. DESCRIPTION AND REQUIREMENTS OF THE CONTRACT

1. This is an Indefinite Delivery Indefinite Quantity Contract (IDIQ) pursuant to Federal Acquisition Regulation (FAR) part 15 and 16, for the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22. This IDIQ is for a Cost Per Test (CPT) system that shall encompass all Chemistry/Immunochemistry reagents and consumables, related testing, analyzers and service maintenance within VISN 22; VA Prescott. This IDIQ requires that the contractor shall provide a system that can conduct all testing as outlined in Attachment A tabs 1 and 2. Contractor agrees to the following terms of the IDIQ exclusively with the VISN facilities listed in 1.6. However, as requirements change, facilities within VISN 22 may be added or deleted by supplemental agreement between the Government and the Contractor.

1.1 This IDIQ does not obligate any funds. The Government is obligated only to the extent of authorized delivery/task orders (DO/TO) issued under the IDIQ by contracting officers (CO) for VISN 22 and the minimums established under section 1.3 which will be obligated via authorized DO/TO’s. All products ordered under DO/TO’s shall be subject to the terms and conditions of this IDIQ.

1.2 VISN 22 has provided estimated requirements in Attachment A. Additional items may be added to this IDIQ that are related to the use of Chemistry/Immunochemistry requirements. All attachments identified in section D are hereby incorporated into this document as a part of the document itself, however this document shall supersede any conflicts of terms and conditions present in Section D attachments that may arise.

1.2.1 Minimum value of IDIQ: $1,000.00

1.2.2 Maximum ceiling value of IDIQ: ($10,000,000.00)

1.3 The IDIQ shall have a five (5) year base period. Within the duration of this IDIQ, each facility may place orders within the ordering base periods of the IDIQ.

1.4 Delivery Orders issued shall be identified by IDIQ Number ___TBD_____ (To Be Determined upon award).

1.5 Participating Facility: See below, 1.6.1. (Additional Facilities within VISN 22 may be added to this contract with an exercise of a supplemental agreement between the CO and Contractor.) Line items within the schedule should reflect the overall volume of the site below and should take into consideration the potential addition of future facilities within VISN 22.

5. Northern Arizona VA Health Care System | 500 North Highway 89, Prescott, AZ 86313

1. Schedule of Supplies and Services - Completed Attachment A shall serve as the Schedule of Supplies, Equipment and Services. All attachments identified in the table of contents shall be incorporated as a part of this contract document.

6. Cost Per Test in this IDIQ is defined as – Please refer to Section 2.2.1.

6. Attachment A, Tab 1, “CHEMISTRY IA CPT” shall provide CPT pricing based upon other tabs in the Schedule which are also reflected in Column C. Column C provides the Total CPT price for every test for base years one (1) through five (5) of the IDIQ.

6. Attachment A, Tab 2, “EST ANNUAL SITE VOL” provides estimated test volumes for all minimally required tests under this IDIQ. These volumes are based upon current usage and utilize a 5% repeat rate and a 3% increase in volume as reflected in Tab 1.

6. Attachment A, Tab 3, “REAGENT CPT” provides the total Cost Per Test under column B for each required test. The amounts listed in column B refer to the all-inclusive cost required to run a test and is reflected in Tab 1. Column D clearly identifies that exact quantities of reagents and consumables needed to a run a single test.

6. Attachment A, Tab 4, “PROPOSED INSTRUMENTS” provides what instrumentation, automation equipment and components shall be provided. Column A provides the proposed instrument / equipment description, column B provides the proposed part / product number, and column C provides the proposed quantities.

6. Attachment A, Tab 5, “PROPOSED TOTAL” provides the total price of the proposed chemistry immunoassay CPT system.

SECTION C

2. STATEMENT OF WORK

2.1 Introduction and Scope of Required Specifications

2.1.1 The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work for all Chemistry, Immunochemistry and infectious disease related testing. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meeting 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 Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory as defined by volumes in Attachment A Tab 2.

2.1.3 The Contractor is required to provide a continuously stocked inventory of reagents, standards, 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.

2.1.4 Equipment: All equipment shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for each of the stations located at the following VISN 22 facility: See section 1.6 and Attachment A.

2.1.5 Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Chemistry/Immunochemistry equipment, supplies and related services.

2.2 Definitions

2.2.1 Cost-Per-Test (CPT) – 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) five year use of equipment, automation line, and automation components, (2) all reagents, standards, vendor-supplied quality controls and materials, supplies, consumable/disposable items, parts, accessories, annual software licenses, ancillary equipment, printers, water systems (if applicable), 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 service & maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance, routine repairs, and emergency repairs) and (4) training for Government personnel. Contractors are required to incorporate the cost of delivery, installation, and removal of equipment into the CPT price or provide at no additional/separate charge. This does not include those items approved for exclusion by the government such as printer paper, labels, etc.

2.2.2 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.

2.2.3 Primary Processing Automation Line – Pre-analytical processing equipment offered to the VA laboratory listed in section 1.6 that will automate the pre-analytical specimen processing functions, as indicated in the general requirements section.

2.2.4 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.

2.2.5 Contractor Middleware System – Generally a separate component/ computer that electronically links the testing instrumentation to manage data, results and workflow. (Not to be confused with Data Innovations or Dawning).

2.2.6 Throughput – The speed that the equipment processes and/or operates reported in units per hour.

2.2.7 TEST MENU: Refer to Attachment A Tab 1 and 2 for test menu and estimated annual volumes by laboratory.

2.3 Instrumentation Requirements

2.3.1 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 technical specifications of this contract. Contract shall provide a system with the following:

Contractor shall provide an Integrated Clinical Laboratory Chemistry/ Immunochemistry Instrumentation and Robotics System (Automated track or line) in accordance with the Attachment A.

2.3.1.1 Equipment shall have sufficient capacity and throughput to meet the volume and service demands as defined in Attachments A Tab 2 during peak workload analysis. The solution should allow for 3% growth in volume per year for the term of the contract with options.

2.3.1.2 The capability of performing analysis on 100% of the required tests listed in section Attachment A Tab 1/2.

2.3.1.3 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment and automation line must fit in existing space. Tertiary instruments proposed that will reside off the automation line will need to fit the current assigned counter space. Measurements are: 25 in Height, 24 in Depth and 35 in Long. See CAD drawings for measurements of main chemistry space.

2.3.1.4 System shall include a patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation

2.3.1.5 Ability to prioritize STAT testing without compromising existing programmed testing.

2.3.1.6 Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run.

2.3.1.7 Carryover for studies shall meet CLIA and CLSI guidelines.

2.3.1.8 The ability to continuously load patient specimens.

2.3.1.9 The ability to detect specimen clots with alert notification.

2.3.1.10 The capability to auto dilute a test when defined limits are exceeded.

2.3.1.11 The capability of incorporating third party reagents through the use of open channels on chemistry analyzers.

2.3.1.12 If the system requires laboratory-grade water, a water system shall be included, not a stipend for a water system.

2.3.2 Calibration and Reagent Management – The system shall be capable of or possess the following:

2.3.2.1 System must have on board reagent stability sufficient to accommodate volumes defined in attachment A.

2.3.2.2 The ability to detect and alert operator of low reagent and consumable levels.

2.3.2.3 The ability to calibrate more than one lot of a reagent at a time.

2.3.2.4 The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations.

2.3.2.5 The capability to calibrate assays during test run without aborting the run.

2.3.2.6 The capability to store, print, and retrieve calibration data from the instrument.

2.3.2.7 Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor.

2.3.2.8 Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration Single lot of reagent for each test/analyte per monthly shipment with a minimum reagent expiration date of 90 days, preferably, unless otherwise specified and approved by laboratory point of contact prior to shipping.

2.3.2.9 Ability to reduce out-of stock issues and on-hand inventory. System shall maximize on-shelf availability and expiration date management.

2.3.3 Specimen Management System / Automated Track – The system shall be capable of or possess the following:

2.3.3.1 A line or track system will be required to connect the testing analyzer. The line or track system will provide an input module, de-capping of specimens, centrifugation capable of producing platelet poor plasma, load balancing between instruments and re-capping of instruments with an output module that will organize samples.

2.3.3.2 Specimen management system to manage and track sample progress and position to maximize efficiency and turnaround times. The system shall also be able to sort specimens based on test requests (Line/track system/ Specimen Management System)

2.3.3.3 Specimen archival through mapping of specimens to racks for storage.

2.3.3.4 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) The ability to prioritize STAT specimens when introduced to automation.

2.3.3.5 Minimize operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen. (i.e. Stat specimen lane for introduction of sample/ Specimen Management System)

2.3.3.6 The ability to detect processing errors and provide error notification. (Specimen Management System)

2.3.3.7 The ability to isolate connected analyzers from the automation and processing equipment when necessary (Specimen Management System).

2.3.3.8 The ability to process both spun and unspun specimens simultaneously (Inlet or similar device).

2.3.3.9 The instrumentation shall be capable of handling all routine sample collection tubes plus other various sized sample containers i.e., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts.

2.3.3.10 The ability to separate the serum/plasma from the blood cells through the process of centrifugation.

2.3.3.11 Minimum requirements for components:

2.3.4 Capper/Decapper – The system shall be capable of or possess the following:

2.3.4.1 The ability to remove the collection caps from a variety of types and sizes of blood collection tubes. (Decapper).

2.3.4.2 The ability to cap and/or seal a variety of types and sizes of blood collection tubes. (Capper).

2.3.5 Barcoding – Barcoding stations located at key points along the line or track system must have the following capabilities of or possess the following:

2.3.5.1 The accuracy of the barcode reading must have less than a 1.0 % failure rate.

2.3.5.2 Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

2.3.5.3 Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric and may be concurrently.

2.3.5.4 Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology.

2.3.5.5 Track reagent inventory by bar code or radio-frequency identification (RFID).

2.3.6 Testing Capability – The system shall be capable of or possess the following:

2.3.6.1 IDMS traceable Creatinine reagent.

Less than 5% of test menu will require sample pre-treatment.

2.3.6.2 Required Analytes- The combined instrumentation and automation track must be capable of analyzing the analytes identified as required in Attachment A;

· if not available directly, then available via the manufacturer and the contractor will assist with set up and validation for third party assays.

2.3.7 Printers and Other Support Items (Support Items) – The system shall be capable of or possess the following:

2.3.7.1 A printer(s) that has the capability of printing a patient report with patient demographic information that includes the patient’s name, medical record number (SSN) and accession or unique identifier number (UID). The contractor must maintain a backup printer on site.

2.3.7.2 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 Software, Connectivity and Conformance Standards

2.4.1 Instrument Software – Internal to testing instrumentation that provides/maintains or be capable of the following:

2.4.1.1 Ability to monitor instrument performance.

2.4.1.2 Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records.

2.4.1.3 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.

2.4.1.4 Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 72 hours in case of interface outage.

2.4.1.5 Capability to record, store and print the following information:

· Required quality control, calibration, and instrument maintenance information.

· Patient demographic information and specimen results.

2.4.1.6 The capability to program a test as a repeat with interfacing of results to overlay initial result.

2.4.1.7 Ability to retransmit patient records to universal interface system (including middleware) in case of interface outage.

2.4.2 Customization - The system shall be capable of or possess the following:

2.4.2.1 Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing)

2.4.2.2 Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology).

2.4.2.3 Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity and set up data management for track engine.

2.4.3 Interface – The system shall be capable of or possess the following:

2.4.3.1 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software as needed) shall be immediately available for implementation to the VA computerized hospital information system.

2.4.3.2 The Contractor shall provide all system configuration options and diagrams for any hardware and/or software with annotation of whether contractor provided or VA provided required for the connection, implementation, and operation of the interface to the VA licensed Data Innovations Instrument Manager.

2.4.3.3 The Contractor shall provide any and all necessary software support for ensuring 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.

2.4.3.4 The contractor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500). Any wireless equipment must be FIPS 140-2 compliant as well, and contractor must provide the FIPS 140-2 certification for any wireless equipment upon request.

2.4.3.5 If there are software upgrades in the instrument during its life, the Contractor is responsible for ensuring that the interface can accommodate any changes in the data stream going to the VA Laboratory Interface Middleware.

2.4.3.6 Technology must interface to VA licensed Data Innovations Instrument Manager sending all appropriate information in order to complete auto verification rules processing within the VA licensed IM. Preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA licensed DI IM.

2.4.4 Connectivity and Conformance - The system shall be capable of or possess the following:

2.4.4.1 Contractor must have existing VA MOU/ISA prior to award which must include remote monitoring and support. Contractor should use remote monitoring to prevent instrument or testing issues as possible in addition to troubleshooting and support. The Contractor shall include a copy of the MOU/ISA as part of their quote with the file named “VA MOU/ISA”. The Contractor shall provide all hardware and software in order to implement the remote support system.

2.4.4.2 The Contractor supplies responses to required documents in order to add systems to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication Protocol, MSD2, and the Risk Analysis Tool.

2.4.4.3 The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network (Windows 10 or Windows 11 and Windows Server 2016/2019).

2.4.4.4 Must be capable of connecting to an HL7 interface and must comply with the VHA Lab HL7 Interface Specifications Document.

· https://www.va.gov/vdl/application.asp?appid=71

· https://www.va.gov/vdl/application.asp?appid=75

2.4.4.5 The contractor’s performance must be in compliance with all applicable state, federal and local laws and regulations.

2.4.4.6 Any software solutions supplied and installed on VA workstations by the contractor must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must be within 2 lifecycles of the most recent TRM approved version. Or the contractor must have the capability obtain a TRM approval without impacting installation timeframes in section 4.

· https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx.

2.5 Support Features

2.5.1 Service Maintenance / Warranty. The system shall be capable of or possess the following:

2.5.1.1 The Contractor shall provide equipment repair and preventative maintenance on all primary instrumentation and ancillary equipment within the provided system (including printers, uninterruptible power supplies and water systems). Any maintenance that would occur less frequently than monthly maintenance shall be the responsibility of the contractor.

2.5.1.2 The contractor provides 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.

2.5.1.3 All equipment, including ancillary equipment, repair service shall be provided Monday through Friday from 07:00AM to 07:00PM. Certain circumstances like the loss of both primary and back up analyzers may dictate the need for repair service to be conducted outside routine business hours. If both the primary and the backup analyzers are down service converts to 24/7 with an 8-hour service response time in order to maintain all operations. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Routine equipment repair response time shall be no more than 24 hours. Delivery of parts and equipment to fix instrumentation must be within 24 hours to prevent excessive downtime and delay of response time at the cost of the contractor.

2.5.1.4 Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date or more frequently based on instruments’ performance.

2.5.1.5 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:

· date and time notified

· date and time of arrival

· serial number, type and model number of equipment

· time spent for repair, and

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

· Cause (i.e. user error, part failure, etc…)

· Each notification for an emergency repair service call shall be treated as a separate and new service call.

2.5.1.6 The Contractor’s warranty shall provide, install, maintain, and repair through the life of the IDIQ and related delivery/task orders, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. UPSs with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, deionizers, filters, preventative maintenance and repair, etc.), and universal interface equipment, 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. Furthermore, the contractor is responsible for carrying out all warranty procedures for replacement including contacting the warranty service.

2.5.1.7 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.

2.5.1.8 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.

2.5.2 This section establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or IDIQ] 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 go live 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 the IDIQ at an effectiveness level of 90% or more.

2.5.2.1 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.

2.5.2.2 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 at no charge 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.)

2.5.2.3 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.

2.5.2.4 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.

2.5.2.5 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.

2.5.2.6 During the term of the IDIQ, 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 may be made by the facility point of contact and contracting officer to replace the malfunctioning equipment with new equipment at no additional charge. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the contract. The same terms and conditions apply to ancillary/support equipment provided under this IDIQ, i.e., water system, printers, UPS, etc.

2.5.2.7 The Contractor shall provide a warranty for all items and services provided under the IDIQ for the duration of the IDIQ and all associated delivery orders.

2.5.3 Reports

2.5.3.1 All reports must be approved by the designated medical personnel. Additional studies will be at the expense of the contractor until results meet the criteria defined by the medical director.

2.5.3.2 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. At the end of each IDIQ year (base and each option), an annual report of sales by participating facility as well as a VISN total will be provided. In addition, a total IDIQ sales/savings report will be provided at the expiration of the IDIQ, to include any extensions. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge shall not be accepted. There will be no additional charges for any reports required as part of the IDIQ. These reports will be in an Excel spreadsheet, multiply tabs may be used, to include a VISN summary tab.

2.5.4 Training

2.5.4.1 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. The CPT shall include key operator training for minimally 2 operators per each instrument installed. Training shall be provided on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two operators per facility 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.

2.5.4.2 In addition, operator training shall be provided by Contractor on-site for all operators on all shifts

2.5.4.3 Additional onsite training will be provided 60-90 days after instrumentation’s go live date.

2.5.4.4 Contractor shall at minimum provide on-site training for up to 8 hours per site as requested by the facility.

2.5.4.5 Contractor will provide example policies and procedures such as standard operating procedure templates.

2.5.5 Waste

2.5.5.1 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. The determination and description shall address the following:

· Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

· Waste ignitability (Reference 40 CFR §261.21)

· Waste corrosivity (Reference 40 CFR §261.22)

· Waste reactivity (Reference 40 CFR §261.23)

· Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

· Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

· Solid Waste (Reference 40 CFR §261.2)

· Exclusions (Reference 40 CFR §261.4)

2.5.5.2 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.

2.5.5.3 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.

2.5.5.4 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.

2.5.6 Upgrade/Updates: The Contractor shall provide updates to the 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 updates” that enhance the model of equipment being offered, i.e. new version of software.

2.6 Records Management

2.6.1 Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2.6.2 Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

2.6.3 Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government Information Technology (IT) equipment and/or Government records.

2.6.4 Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

2.6.5 Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

2.6.6 The Government Agency owns the rights to all data/records produced as part of this contract.

2.6.7 The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

2.6.8 Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

2.6.9 No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

2.6.10 Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

2.7 VA INFORMATION CUSTODIAL LANGUAGE

2.8.7 The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/subcontractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

2.8.8 In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function.