Attachment B - Statement of Work - Dry Chemistry Immunochemistry - Amended.docx

STATEMENT OF WORK (SOW)

DRY CHEMISTRY / IMMUNOCHEMISTRY SYSTEM

SECTION A – Introduction OF REQUIREMENTS Southern Arizona VA Health Care System (SAVAHCS) has a requirement for an Indefinite Delivery Indefinite Quantity Contract (IDIQ), Cost Per Test (CPT) system that shall provide all Dry Chemistry / Immunochemistry related testing within SAVAHCS. The contractor agrees to provide a price schedule that shall encompass Cost Per Test (CPT) Pricing structures only, in accordance with the terms and conditions of the SOW to SAVAHCS, identified as the Government herein. The services and prices are specified in the sections entitled Schedule of Supplies/Services of this contract.

Period of Performance: The duration of the IDIQ shall be for a one-year base period followed by three one-year options. Within the duration of this IDIQ, the facility may place orders within the ordering base and exercised options period of the IDIQ.

Participating Facilities: The scope of this contract covers the entire area of responsibility (AOR) of SAVAHCS Main Campus.

Southern Arizona VA Health Care System (VA Tucson) 3601 S. 6th AVE.

Tucson, AZ 85723

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

1.1. Cost-Per-Test (CPT) in this IDIQ is defined as – Individual billing cost on a per test basis inclusive of all reagents, supplies, consumables, instrumentation, automation/track standard shipping, labor/services, training, and installation as defined throughout this section.

1.2. Attachment A, Tab 1, “BASE” shall provide CPT pricing and estimated annual cost for the duration of the base term. Columns B – D provide the description of the Brand Name requirements for the solicitation. Column E provides the Minimum System Requirements that must be met at a minimum for the offer to be considered responsive and responsible. Columns F – H shall be completed with additional product details if an equivalent product is offered. Column I shall demonstrate how the Minimum System Requirements are met if an equivalent product is offered. Column J provides the quantities of the requested items including number of analyzer equipment and estimated annual test volumes. Column L shall provide Cost-Per-Test prices for each test that is listed. Each CPT price shall consider the following: All costs related to reagents, supplies, consumables, standard shipping, and service shall be based upon estimated annual consumption/usage whereas instrumentation, automation/track, training, and installation shall be amortized over the contract duration and incorporated into each CPT price.

1.3. Attachment A, Tabs 2 - 4, shall provide CPT pricing and estimated annual costs for option years 1 - 3. The estimated volumes are based upon the usage rate of the previous year and a 3% increase in volume.

1.4. Attachment A, Tab 5, “TOTAL AMOUNT” reflects the estimated total contract value across Tab 1. Base through Tab 4. Option 3.

1.5. Attachment A, Tab 6, “CONSUMABLES AND SUPPLIES” provides a list of consumables, supplies, and other items that are required to run the reagents included in the CPT.

1.6. Attachment A, Tab 7, “SEPARATELY PRICED ITEMS” provides the individual cost of items available to optionally purchase separate from the CPT. This may include items such as any additional tests and consumables not included in the CPT, cost of expedited shipping, cost of additional training slots, equipment relocation costs, etc.

SECTION B – DESCRIPTION / SPECIFICATIONS / STATEMENT OF WORK

1. SCOPE OF PROCUREMENT:

2.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work for all Dry 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). Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by the laboratory from their current state.

2.2. 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.

2.3. 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. Equipment shall be acquired for the clinical laboratory located at SAVAHCS.

2.4. 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.

2.5. 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, or supplies are used in troubleshooting the equipment, 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 routine supplies delivery.

DEFINITIONS:

2.6. Cost per Test (CPT) – Individual billing cost on a per test basis inclusive of all reagents, consumables, instrumentation, standard shipping, labor/services, and installation.

2.7. 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.

2.8. Primary Processing Automation Line – Pre-analytical processing equipment that will automate the pre-analytical specimen processing functions, as indicated in the general requirements section.

2.9. 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.

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

2.11. TEST MENU: Refer to Attachment A for desired test menu, equipment needed, and estimated annual volumes.

DRY CHEMISTRY IMMUNOCHEMISTRY MINIMUM SYSTEM REQUIREMENTS:

2.12. System must be entirely a “dry” chemistry system due to Southern Arizona VA Health Care System’s facility assessment and findings of inadequate sewer lines.

2.13. Must be able to perform all tests listed in Attachment A without potential of carryover and contamination of patient specimens

2.13.1. Equipment must have sufficient capacity and throughput to satisfy chemistry and immunoassay testing needs of facility based on volumes and 3% increase in volume per year as provided in Attachment A.

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

2.14. The proposed system (including instruments, reagents, supplies, quality controls) must be FDA approved.

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

2.16. The ability to continuously load patient specimens.

2.17. The ability to detect specimen clots with alert notification.

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

2.19. A line or track system will be provided to connect all testing analyzers with the capability of incorporating new technologies via automated line expansion.

2.20. 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)

2.21. Specimen archival through mapping of specimens to racks for room temperature samples or to a refrigerated stock yard for easy retrieval once moved off-line.

2.22. A total equipment footprint that when installed in the laboratory shall not negatively impact the functionality/operations of that laboratory.

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

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

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

INSTRUMENTATION REQUIREMENTS

2.26. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimum 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 in the attachments to the SOW. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this contract. Those additional analyzer(s) offered should be the same analyzer as the primary analyzer, acting as a mirrored instrument.

2.27. Calibration and Reagent Management

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

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

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

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

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

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

2.27.7. The contractor shall provide a lot number sequestering program to retain the same lot numbers on qualifying reagent and to reduce the number of calibrations with each new shipment of reagent.

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

2.28.1. A line or track system will be provided to connect all testing analyzers with the capability of incorporating new technologies via automated line expansion.

2.28.2. 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)

2.28.3. Specimen archival through mapping of specimens to racks for room temperature samples or to a refrigerated stock yard for easy retrieval once moved off-line.

2.28.4. 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)

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

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

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

2.28.8. 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.

2.28.9. The ability to separate the serum/plasma from the blood cells through the process of centrifugation. For high volume labs, a second centrifuge or as many as appropriate shall be integrated into the line.

2.29. Capper/Decapper

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

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

2.30. Barcoding - Barcoding stations located at key points along the line or track system must have the following capabilities:

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

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

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

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

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

2.31. Printers and Other Support Items

2.31.1. 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 repair or replace the printer if malfunctioning within 24 hours for the duration of the contract.

2.31.2. 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.

SOFTWARE, CONNECTIVITY, AND CONFORMANCE STANDARDS

2.32. Instrument Software – Internal to testing instrumentation that provides/maintains the following:

2.32.1. Ability to monitor instrument performance.

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

2.32.3. 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.

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

2.32.5. Capability to record, store and print the following information:

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

2.32.7. Patient demographic information and specimen results.

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

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

2.33. Customization

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

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

2.33.3. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

2.33.4. At a minimum consultation should include auto verification workflows and/or an auto verification rules library to be used during setup. The contractor shall provide education to key personnel on how to maintain functionality of these operations. At minimum this education should include middleware training for standard operations and rules writing.

2.34. Interface

2.34.1. 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.

2.34.2. 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.

2.34.3. 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.

2.34.4. The contractor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements. 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.

2.34.5. 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.

2.34.6. 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.

2.35. Connectivity and Conformance

2.35.1. 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.

2.35.2. 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.

2.35.3. The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network (Windows 10 and Server 2012/2016).

2.35.4. 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

2.35.5. The contractor’s performance must follow all applicable state, federal and local laws, and regulations.

2.35.6. 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 7.

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

2.35.7. Contractor must have a Memorandum of Understand/Information Security Agreement (MOU/ISA) with the VA or the capability to obtain an MOU/ISA without impacting installation timeframes in section 7.

SUPPORT FEATURES

2.36. Service Maintenance / Warranty

2.36.1. The Contractor shall be able to provide equipment repair and preventative maintenance on all primary instrumentation and ancillary equipment within the provided system.

2.36.2. 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.

2.36.3. All equipment, including ancillary equipment, repair service shall be provided Monday through Friday from 08:00 AM to 05:00 PM. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. If one analyzer is down service converts to 24/7 to maintain all operations. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than 4 hours. Delivery of parts and equipment to fix instrumentation must be within 24 hours to prevent excessive downtime at the cost of the contractor.

2.36.4. 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.

2.36.5. 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.

2.36.6. The Contractor shall provide, install, maintain, and repair through the life of the IDIQ, 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), 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.

2.36.7. 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.

2.36.8. 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.

2.37. 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.

2.37.1. 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.

2.37.2. 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.)

2.37.3. 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.

2.37.4. 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.

2.37.5. 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.

2.37.6. 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 (hereafter referred to as POC) and/or 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.

2.37.7. 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

2.38. Training

2.38.1. 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.

2.38.2. In addition, operator training shall be provided by Contractor on-site for all operators on all shifts (day shift: 7:30AM – 4:00PM, evening shift: 3:30PM – 11:00PM and midnight: 10:00PM – 8:00AM), as applicable.

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

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

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

2.39. Waste

2.39.1. 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.

2.39.2. The Contractor shall provide a recycling program for the microslide cartridges at no cost to the customer.

2.39.3. 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 decide 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)

2.39.4. The contractor will provide written instructions and training material to ensure SAVACHS 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.

2.39.5. 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, thimerosal, 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:

· pH

· Flash point (to higher than 200F)

· BOD; biochemical oxygen demand

2.40. Upgrade/Updates:

2.40.1. The Contractor shall provide updates 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 updates” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, update 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 IDIQ; however, it does refer to significant changes in the hardware operational capability. Should the VISN decide to upgrade their current equipment i.e. - replacement of existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

INSPECTION AND ACCEPTANCE/DELIVERIES & PERFORMANCE

2.41. Installation/Implementation

2.41.1. Implementation/transition timeframe: The facility shall have complete installation and go live of their system within 6 months of award of this IDIQ.

2.41.2. Contractor shall execute an implementation plan which includes:

2.41.2.1. Installation - Contractor shall make every effort to conduct a concurrent implementation at the facility with weekly collaborative meeting. Contractor shall provide a dedicated project manager throughout the entire implementation. Installation shall also include conversion of all current data minimally including operator profiles.

2.41.2.2. Testing- Shall include at minimum a test of all analytes in addition through all testing phases (pre- analytical, analytical, and post-analytical). In addition, training must be provided to the facility.

2.41.2.3. Acceptance-Must meet the approval requirements of accrediting agencies and laboratory medical director approval at each facility to meet accreditation standards.

2.41.2.4. Go-Live- Dedicated project management and technical support must be available the day of go-live for 3 consecutive days.

2.41.2.5. Post Go-Live Follow Up- Check-in should include at least a two week and 30 days after go-live date.

2.41.2.6. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, consumable/disposable items, parts, accessories, and any other item required to establish instruments for operation for performance of acceptance testing. This applies to equipment as well as additional or replacement equipment placed under the terms and conditions of this IDIQ. The Contractor shall perform/, 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 statistical analysis as stated in the Method Performance/Validation section below and provide a hard copy of data in an organized, clearly comprehensible format.

2.41.2.7. The Contractor shall provide validation for both dual slides and single slide assay for qualifying assays.

2.41.2.8. The Contractor shall assist customer in the validation of plasma specimen type for all qualifying assays.

2.41.2.9. Onsite Go live Instrument and Automation Support Requirements shall consist of 48 hours of continuous support. Daily onsite support for a total of five business days for each phase of implementation.

2.41.2.10. Must support successful implementation and a non-manual method of uploading historical data, i.e., operators and meters/analyzers in the transition from different system.

2.42. Post Implementation

2.42.1. Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow. This shall include sending personnel to the site to optimize the analyzer, automation and data management work flows six months and twelve months after the system has gone live.

2.42.2. Optimization must include supplier to provide minimum staffing levels for pre-analytical, analytical, and post-analytical test performance.

2.43. Method Performance/Validation

2.43.1. Carryover for studies will meet CAP and CLSI guidelines.

2.43.2. 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 and must be approved by the medical director.

2.43.3. Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run by 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.

2.43.4. 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 minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

2.43.5. 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.

2.43.6. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate are applied.

2.43.7. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

2.43.8. 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.

2.43.9. A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects with medical director approval. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 40 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.

2.43.10. 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.

2.43.11. 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.

2.44. Completion of Contract

2.44.1. Ownership of Equipment - Title to the equipment shall remain with the Contractor unless otherwise agreed. 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. Should

2.44.2. 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.

2.44.3. Delivery: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in section A.3.

2.44.4. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The facility POC shall be required to notify the Contractor when delivery locations have been changed.

2.44.5. All deliveries shall be made during normal working hours from 8:00 AM to 5:00 PM and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, IDIQ number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Standard orders shall be delivered within no more than 30 working days after receipt or placement of order.

2.44.6. 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 monthly standing order/routine supplies delivery.

HOURS OF WORK

2.45. The IDIQ shall include a minimum five (5) days a week, nine (9) hours a day full-service agreement to include all necessary service calls. Contractor shall also provide technical support via phone seven (7) days a week, twenty-four (24) hours a day. After hours and weekends in person service are chargeable as per line items within Attachment A.

2.46. Any service performed during other than normal work hours must be approved in advance by the facility POC or CO.

2.47. Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the POC in advance as approved in the delegation of authority. The rates shall be chargeable as per Attachment A.

2.48. When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

SECTION C - Special IDIQ Requirements

1. Physical Security and Facility Considerations

3.1. Identification, Parking, Smoking and VA Regulations (For any onsite services):

3.1.1. The Contractor employees and/or Subcontractors approved by the facility POC shall wear visible identification at all times while on the premises of the facilities within the VISN. Identification shall include but not be limited to a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor Employees shall maintain a professional appearance commensurate to their industry.

3.1.2. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. They will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

3.1.3. Any interior or exterior doors that shall be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit. At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

3.1.4. Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the facility POC. The Contractor’s staff shall also be required to sign in and out each day at a designated location determined by the facility POC.

3.1.5. The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government

3.1.6. Smoking is prohibited on the property of all facilities within VISN 22.

3.1.7. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

3.1.8. The Contractor shall not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

Information Technology Security Considerations

3.2. Prior to termination or completion of this Contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this Contract 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 of the Contract.

3.3. 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 Contract 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 returned to 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 of the Contract.

3.4. 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:

3.4.1. Contractor must accept the system without the drive;

3.4.2. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

3.4.3.