Attachment B - Statement of Work - Electrophoresis.docx

STATEMENT OF WORK – PROTEIN ELECTROPHORESIS ANALYSIS

1. INTRODUCTION TO REQUIRED SPECIFICATIONS

1.1. Veterans Integrated Service Networks 22 (VISN 22), Pathology and Laboratory Medicine Services (P&LMS) requires a serum and urine protein electrophoresis system for multiple sites listed in Section 1.5. Contractor shall provide serum and urine protein electrophoresis instrumentation that utilizes capillary and agarose gel electrophoresis on a Cost-Per-Test (CPT) basis for requirements identified in Attachment A. The Government intends to award a CPT Indefinite-Delivery Indefinite-Quantity (IDIQ) contract to a single contractor for serum and urine protein electrophoresis instrumentation. This electrophoresis system will allow the end user(s) to perform laboratory testing and reporting of protein abnormalities that is essential for patient care. This supports the mission of the VA to provide timely, accurate and appropriate laboratory services in support of patient care for veterans. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market.

1.2. Delivery orders shall be utilized to obligate funding for required supplies and services. Each delivery order shall be subject to the terms and conditions of this IDIQ. Provided items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. 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, Contracting Officer Representative’s (COR), and the VISN program office. These individuals shall be identified upon award of the IDIQ.

1.3. Equipment: All equipment shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for stations located at the following VISN 22 facilities: See Section 1.5 and Attachment A.

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

1.5. Participating Facilities: Additional Facilities within VISN 22 may be added to this contract with an exercise of a supplemental agreement between the Government and Contractor. A Contracting Officer Representative (COR) shall be assigned as a primary point of contact. Pricing within the schedule should reflect the overall volume of all sites below and should take into consideration the potential addition of future facilities within VISN 22.

1.5.1. VA Greater Los Angeles Healthcare System | 11301 Wilshire Blvd, Los Angeles, CA 90073

1.5.2. VA San Diego Healthcare System | 3350 La Jolla Village Dr, San Diego, CA 92161

1.5.3. VA Long Beach Healthcare System | 5901 E. 7th Street, Long Beach, CA 90822

1.5.4. VA Phoenix Healthcare System | 650 E Indian School Rd, Phoenix, AZ 85012

1.5.5. VA Tucson Healthcare System | 3601 S 6th Ave, Tucson, AZ 85723

1.5.6. VA Albuquerque Healthcare System | 1501 San Pedro Dr SE, Albuquerque, NM 87108

1.6. 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.

1.6.1. Cost Per Test in this IDIQ is defined as – Individual billing cost on a per test basis inclusive of all reagents, consumables, instrumentation, standard shipping, labor/services, training, and installation as defined throughout section 1.6.

1.6.2. Attachment A, Tab 1, “VISN CPT” shall provide CPT pricing based upon other tabs in the Schedule which are also reflected in Columns C – G. Column H provides the Total CPT for every test for years one (1) through five (5) of the IDIQ. Column I represents the CPT for years six (6) – eight (8). The cost of instrumentation, automation/track hardware, software (not including annual licenses), and installation shall only apply to years one (1) – five (5) of the CPT or when the initial five (5) year volume is reached. Years 6 (six) – eight (8) shall only include Reagents CPT and Service as the cost of all other items have amortized under year’s one (1) – five (5).

1.6.2.1. Should new equipment be requested after year five to replace current equipment, a separate additional component to the cost per test shall be identified via supplemental agreement between the contractor and the government to amortize the value of the equipment with installation costs across the remaining estimated volumes.

1.6.3. 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.

1.6.4. Attachment A, Tab 3, “REAGENTS CPT” provides a component of the total Cost Per Test under column B for each required test. The amounts listed in column B only refer to the cost of reagents and consumables 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.

1.6.5. Attachment A, Tab 4, “INSTRUMENTS” provides what instrumentation and related equipment the contractor shall provide and their individual associated costs. Column P shall provide total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.6.6. Attachment A, Tab 5, “OTHER” provides what ancillary items and other items the Contractor shall provide as a part of the CPT. Also include training slot costs and other related services. Column P shall provide total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.6.7. Attachment A, Tab 6, “SERVICE” provides the CPT cost of service/maintenance and software licenses for duration of the IDIQ under column M.

1.6.8. Attachment A, Tab 7, “INSTALL” provides the cost of initial installation and a clear description of all installation activities. Column C provides total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.6.9. Attachment A, Tab 8, “IND ITEM COST” provides the individual cost of all items within the CPT and items available to optionally purchase individual separate from the CPT.

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 be able to simultaneously perform the complete profile as described below to 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. Offeror may provide a single instrument or multiple instruments to meet the requirements within this Statement of Work. If Contractor offers a family of analyzers, VISN 22 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

2.1.3. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A.

2.1.4. 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 FDA-approved, if available, and 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.

2.1.5. 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, 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.

2.2. DEFINITIONS:

2.2.1. Cost per Test (CPT) – Individual billing cost on a per test basis inclusive of the following:

2.2.1.1. Equipment, reagents (amount needed to perform the total of tests specified by the participating facility for the fiscal year), controls, consumables, service, parts, training, installation, and standard shipping.

2.2.1.1.1. Quality Control

2.2.1.1.2. Service coverage

2.2.1.1.3. Routine shipping and handling, additional charge for expedited shipping

2.2.1.1.4. 2 Training slots per instrument

2.2.1.2. Costs are calculated based on total annual estimated volume provided in Attachment A.

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 (see Attachment C – Business Associate Agreement Template).

2.2.3. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes.

2.2.4. Capillary electrophoresis: Is an analytical technique that separates ions based on their electrophoretic mobility with the use of an applied voltage.

2.2.5. Immunofixation: Permits the detection and typing of monoclonal antibodies or immunoglobulins in serum or urine.

2.2.6. 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.

2.3. ELECTROPHORESIS MINIMUM SYSTEM REQUIREMENTS:

2.3.1. Operational Features - The instrumentation offered shall have the following:

2.3.1.1. The capability of performing analysis on 100% of the tests listed in Attachment A.

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2.3.1.2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A, with a 5% repeat rate and 3% increase each year.

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2.3.1.2.1. The maximum turn-around-time between samples must allow for a minimum throughput of at least 30 Serum Protein Electrophoresis and 10 Urine Protein Electrophoresis results per day on the Capillary system.

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2.3.1.3. The accuracy of the barcode reading must have a documented failure rate less than a 1%.

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

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2.3.1.3.2. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric depending on site.

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2.3.1.4. Capability to store and/or archive at least 100,000 patient results in database for immediate recall.

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2.3.1.5. Must include specimen handling/loading system;

2.3.1.5.1. Primary specimen container(s) loaded into a storage area, e.g. tray, rack, wheel, etc. for automated processing.

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2.3.1.5.2. Instrument should be able to handle primary tubes as well as sample cups.

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2.3.1.5.2.1. Contractor shall provide the minimum specimen requirement to perform each test outlined in Attachment A.

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2.3.1.5.3. Ability to accept various types of sample containers.

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2.3.1.6. Comprehensive quality control program to include serum and urine protein electrophoresis and immunofixation.

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2.3.1.7. Comparative patient result recall for past patient testing.

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2.3.1.8. Automatic identification of fractions to simplify operator editing Click or tap here to enter text.

2.3.1.9. Capillary instrument must have full automation for workflow and operator safety Click or tap here to enter text.

2.3.1.9.1. Instrument should have full walk-away capabilities after samples are loaded by staff.

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2.3.1.10. Gel instrument must have at least semi-automation for workflow and operator safety Click or tap here to enter text.

2.3.1.11. Automatic pipetting from primary tube and aliquote tube on Capillary Click or tap here to enter text.

2.3.1.12. Auto dispensing of antisera for immunofixation on Gel Click or tap here to enter text.

2.3.2. Technical Features - The instrumentation shall have the following:

2.3.2.1. Must be approved by the Food and Drug Administration (FDA) Click or tap here to enter text.

2.3.2.2. Must utilize Capillary Ion Electrophoresis Technology to analyze serum and urine for protein electrophoresis.

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2.3.2.3. Must have capability to utilize Immunotyping/ Capillary Ion Electrophoresis Technology to characterize abnormal proteins on urine and serum.

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2.3.2.4. Must have capability to utilize Immunofixation (gel) technology to characterize abnormal proteins on urine and serum as reflex to Immunotyping.

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2.3.2.5. Agarose Gel processor/stainer with built-in scanner to perform both primary and supplemental testing.

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2.3.2.6. Provide positive sample identification from primary tube to final results utilizing barcoded racks and tubes and high-resolution built-in barcode reader.

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2.3.2.7. Primary tube sampling and direct sampling from primary tubes with mechanisms in place to avoid cross contamination.

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2.3.2.8. Electronic network for immediate access of results by pathologist.

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2.3.3. Hardware Features - The instrumentation shall have the following:

2.3.3.1. The instrument should be functional without the need for additional plumbing for water and waste disposal.

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2.3.3.2. The instrument(s) should include an on-board monitor/screen that is easily readable. Vendor shall provide information regarding resolution of on-board screen.

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2.3.3.3. A printer 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).

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2.3.3.4. An uninterruptible power supply with line conditioner for each instrument provided.

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2.4. STATEMENT OF WORK / OTHER REQUIREMENTS

2.4.1. Interface Requirements

2.4.1.1. 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.

2.4.1.2. 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.

2.4.1.3. The Contractor is responsible for everything leading up to the middleware including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

2.4.1.4. The vendor 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.

2.4.1.5. 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.

2.4.1.6. 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.

2.4.1.7. If the Contractor shall provide remote support, the contractor has established a VA national MOU/ISA between Contractor and VA prior to award. If the Contractor currently has a valid MOU/ISA, 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.

2.4.1.8. 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.

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

2.4.1.10. When requested, the contractor shall help sites implement an auto-verification script in VISTA from the VA licensed DI IM middleware rules package.

2.4.2. Method Performance/Validation Requirements:

2.4.2.1. Method performance/comparison shall be at the expense of the Contractor, shall include material and reagents as required or recommended based on manufacturer’s specifications, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. The method validation will include the following:

2.4.2.2. Correlation studies for each assay. A minimum of 50 samples spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method.

2.4.2.3. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Where applicable, intra-VISN facility variations shall be kept at an absolute minimum.

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

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

2.4.2.6. 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.

2.4.3. 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 shall not be accepted. There will be no additional charges for any reports required as part of the IDIQ.

2.4.4. Support Features:

2.4.4.1. 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.

2.4.4.2. 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. 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 of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

2.4.4.3. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation. 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 two operators per facility at inception and one 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.

2.4.4.4. 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 and any incremental support equipment, e.g. water system and printers, offered according to the following terms:

2.4.4.4.1. Service Requirements:

2.4.4.4.1.1. 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.

2.4.4.4.1.2. Equipment repair response time shall be no more than 24 hours.

2.4.4.4.1.3. Service agreement to cover 7 days per week, business hours unless both instruments are down then agreement converts to emergent 24/7.

2.4.4.4.1.4. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2.4.4.4.1.5. 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:

2.4.4.4.1.5.1. date and time notified

2.4.4.4.1.5.2. date and time of arrival

2.4.4.4.1.5.3. serial number, type and model number of equipment

2.4.4.4.1.5.4. time spent for repair, and

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

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

2.4.4.5. 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, need for upgraded OS on desktop for computer security, 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.

2.4.4.6. Ancillary support equipment - The Contractor shall provide, install and maintain 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. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, 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.

2.4.4.7. 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.

2.4.4.8. 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. Documentation shall be submitted as an attachment to the Contractor’s quote and the file shall be named “Characterization of Waste – Section 1.4.21.11”.

2.4.4.8.1. The determination and description shall address the following:

2.4.4.8.1.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

2.4.4.8.1.2. Waste ignitability (Reference 40 CFR §261.21)

2.4.4.8.1.3. Waste corrosivity (Reference 40 CFR §261.22)

2.4.4.8.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

2.4.4.8.1.7. Solid Waste (Reference 40 CFR §261.2)

2.4.4.8.1.8. Exclusions (Reference 40 CFR §261.4)

2.4.4.8.2. 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 shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.4.4.9. 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 shall be determined and documented. Any mercury containing reagents shall 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) shall be developed and SDS sheets shall 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 shall be included with Contractor response:

2.4.4.9.14. pH

2.4.4.9.15. Flash point (to higher than 200F)

2.4.4.9.16. BOD; biochemical oxygen demand

2.4.4.10. 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. Documentation shall be submitted as an attachment to the Contractor’s quote and the file shall be named “Description of Waste – Section 1.4.21.12.2”.

2.4.4.11. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the IDIQ. 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 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.4.4.11.1. Upon award of a IDIQ, the transition period for the awarded IDIQ to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.4.4.11.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded IDIQ 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 IDIQ for cause under the Termination for Cause clause of the IDIQ.

2.4.4.11.3. At the end of 90 days from award of the IDIQ, the awarded Contractor shall have full and sole responsibility for services under the awarded IDIQ.

2.4.5. 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 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 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 IDIQ at an effectiveness level of 90% or more.

2.4.5.1. 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.

2.4.5.2. 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.)

2.4.5.3. 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.

2.4.5.4. 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.

2.4.5.5. 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.

2.4.5.6. During the term of the IDIQ, shall 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 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. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

2.4.6. 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.

2.4.7. 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.

2.4.8. Hours of Work

2.4.8.1. 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.

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

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

2.4.8.4. 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.

3. SPECIAL IDIQ REQUIREMENTS

3.1. Physical Security and Facility Considerations

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

3.1.1.1. The Contractor employees and/or Subcontractors approved by the COR 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.

3.1.1.2. 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. The VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

3.1.1.3. 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.

3.1.1.4. 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 COR. The Contractor’s staff shall also be required to sign in and out each day at a designated location determined by the COR.

3.1.1.5. 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

3.1.1.6. Smoking is prohibited inside any buildings at facilities within VISN 22.

3.1.1.7. 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.

3.1.1.8. 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.

3.2. Insurance Requirements for work performed on Facility Grounds

3.2.1. The Contractor agrees to procure and maintain, while the Contract is in effect, Workers Compensation and Employee’s Public Liability Insurance in accordance with Federal and State of California and/or Nevada laws.

3.2.2. The Government shall be held harmless against any or all loss, cost, damage, claim expense or liability whatsoever, because of accident or injury to persons or property of others occurring in the performance of this Contract.

3.2.3. The Contractor shall be responsible for all damage to property, which may be done by him, or any employee engaged in the performance of this Contract.

3.2.4. Before commencing work under this Contract, the Contracting Officer shall require the Contractor to furnish certification from his/her insurance company indicating that the coverage specified by FAR 52.228-5 and per FAR 28.307-2 has been obtained and that it may not be changed or canceled without guaranteed thirty (30) day notice to the Contracting Officer.

3.2.5. Contractor is required to provide copies of proof of Workers Compensation and Employee Public Liability Insurance within fifteen (15) calendar days after notification of Contract award.

3.3. Information Technology Security Requirements

3.3.1. The Contractor shall 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 shall purge all patient sensitive information prior to departure from the facility.

3.3.2. Prior to termination or completion of this IDIQ, Contractor/subcontractor shall not destroy information received from VA, or gathered/created by the Contractor in the course of performing this IDIQ without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor shall 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 shall be sent to the VA Contracting Officer within 30 days of termination or completion of the IDIQ.

3.3.3. 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 shall be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the IDIQ 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 shall be returned to the VA for sanitization or destruction or the Contractor/subcontractor shall self-certify that the media has been disposed of per 6500.1 requirements. This shall be completed within 30 days of termination or completion of the IDIQ or disposal or return of the IT equipment, whichever is earlier.

3.3.4. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information shall not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

3.3.4.1. Contractor shall accept the system without the drive;

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

3.3.4.3. VA shall reimburse the company for media at a reasonable open market replacement cost at time of purchase.

3.3.5. 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;

3.3.5.1. The equipment Contractor shall 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 Please see Attachment C – Business Associate Agreement Template.

3.3.5.2. Any fixed hard drive on the device shall 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 IDIQ.

3.3.5.3. 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.

3.3.6. See Attachment D - VA Handbook 6500.6, for additional IT terms and conditions that shall apply to this IDIQ.

3.4. Training

3.4.1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

3.4.1.1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix D relating to access to VA information and information systems;

Please see Attachment D – VA Handbook 6500.6, Appendix D – Contractor Rules of Behavior.

3.4.1.2. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

3.4.1.3. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

3.4.1.4. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] Mandatory TMS Training Please see Attachment E - Mandatory Training for VA Contractor Personnel.

3.4.2. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

3.4.3. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.