SOW.docx

1. STATEMENT OF WORK

1.1. Introduction and Scope of Required Specifications:

The contractor shall provide osmolality testing equipment that meets all the following requirements:

1.1.1. Primary analyzer(s)- Capital Purchase of 2-osmometers for service and reagents. Base equipment offered that shall fully support the scope of operations (minimal requirements). The instrument shall be capable of simultaneously performing 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). The contractor shall identify if their test and specimen types are FDA approved.

1.1.2. Equipment: All equipment delivered to the participating medical center and shall be new, state of the art, and not recertified nor refurbished.

1.1.3. Industry Standards: Unless otherwise stated, all equipment shall be held up to current industry standards for such equipment is present in the current marketplace for Clinical osmometer equipment, supplies and related services.

1.1.4. Contractor must follow all applicable state, federal and local laws, and regulations related to laboratory testing.

1.2. General Requirements

1.2.1. Clinical Laboratory Osmometer Analyzer – Automated system for the handling and accurate analysis, data review, and reporting of human osmolality test results. The osmometer shall use freezing point depression to determine the osmolality of aqueous solutions (urine and serum). The analyzer offered by the contractor shall fully support the estimated annual site volume listed on the schedule.

1.3. Instrumentation Salient Characteristics:

1.3.1. Analyzer(s) –Contractor shall provide Clinical Osmometer analyzer(s) that meet the following requirements:

The ability to use a variety of primary tube sizes.

Performs multisampling of specimens using the same primary tube.

Results shall be fast and accurate.

Interface with LBVAHCS lab information system (LIS) for seamless transmission of test results to LIS.

The osmometer shall have built-in quality control software that includes statistical monitoring of daily QC, ability to set custom ranges, set action limits for out-of-range QC and a supervisor menu with password protection and lockout features.

The osmometer shall have a measuring range of 0 – 2000 mOsm/kg H2O, and run with national standards for accuracy and precision Calibrations are to be stable by minimum CLIA specifications.

1.3.2. Barcoding – Equipment must be able to support multiple barcode formats (Code 39, Code 128) Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology.

1.3.3. Printers and Other Support Items (Support Items): The analyzer must have an optional printer for purchase. (if necessary)

1.4. Software, Connectivity and Conformance Standards: The instrument software shall have capability to connect to other equipment and software systems that meet the following requirements:

1.4.1. Instrument Software – Internal testing instrumentation software that provides/maintains the following:

Ability to monitor instrument performance.

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

Capability to record, store and print the following information:

· Quality control, calibration, and instrument maintenance information.

· Patient demographic information and specimen results.

Ability to retransmit patient records to the Laboratory Information System (including contractor provided middleware) in case of interface outage.

1.4.2. Interface

Interface Requirements:

1.4.2.1.1. The Contractor shall provide 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.

1.4.2.1.2. 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 with certificate of compliance.

1.4.2.1.3. The Contractor supplies responses to required documents to add systems to the VA network including but not limited to the VA Form 6550, Ports Protocols Services, MSD2, network Topological diagram and Equipment Inventory hardware/software list.

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

If the Operating System (OS) and/or Firmware are updated or the OS reaches end of life during the contract period, the vendor shall update OS and/or Firmware at no additional cost. Additionally, if the hardware requires an update or replacement to support the OS/Firmware, the vendor shall update/provide the needed hardware at no additional cost.

Sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.

Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation.

Ability to retransmit patient records to universal interface system in case of interface outage.

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

Technology must interface to VA licensed Data Innovations Instrument Manager sending all appropriate information 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.

1.4.3. Connectivity and Conformance

Contractor shall meet VA OI&T information security requirements IAW VA Directive 6500.

Contractor shall provide remote monitoring and support of the osmometer system while the manufacturer’s warranty is active. Contractor shall use remote monitoring to prevent instrument or testing issues, when possible, in addition to troubleshooting and support. The Contractor shall provide all hardware and software to implement the remote support system.

The osmometers system’s operating software version must be approved for use on the VA network (Windows 10 and Server 2012/2016).

The osmometer system 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 Any software and hardware 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 appear on a TRM that is within 2 lifecycles of the most recent TRM approved version. For software or hardware solutions that do not meet these requirements at the time of contract award, Contractor shall obtain the required TRM approval without impacting installation timeframes.

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

1.5. Support Features

1.5.1. Waste

The Contractor shall provide documentation demonstrating that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges Contractor provides 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) The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

Contractor shall provide a description of all wastes the equipment or process 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 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.

The documentation the contractor provides will be used to work with the medical center, CBOCs, and the public or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system.

Ability to separate alcohol waste from other waste for appropriate environmental disposal.

2. PACKAGING & MARKING

2.1. Packaging

2.1.1. All equipment shall be adequately packaged to prevent damage during shipping, handling, and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

2.2. Marking

2.2.1. All items shall be marked clearly with the Contract Number, Obligation number, and delivery location within the facility, i.e., Pathology & Laboratory Services.

3. DELIVERIES & PERFORMANCE

3.1. Delivery: The Contractor shall deliver all osmometer analyzers to LBVAHCS.

3.1.1. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Point of Contact (POC) will notify the Contractor when delivery locations have been changed.

3.1.2. All deliveries shall be made from 8:00 a.m. to 4:00 p.m., Monday through Friday, and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete contract number, purchase order number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Standard orders shall be delivered no more than 30 working days after receipt or placement of order.

3.2. Support Features-

3.2.1. 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.

3.2.2. Service Maintenance / Warranty

The Contractor shall be able to provide equipment repair and preventative maintenance on all primary instrumentation and ancillary equipment within the provided system(s) according to manufacturer specifications, and laboratory regulatory bodies, such as CLIA, CAP, VA National Enforcement Office, and TJC.

The contractor provides a technical assistance center which will be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of one (1) hour.

All equipment, including ancillary equipment, and repair service shall be provided Monday through Friday from 8:00a.m. to 4:00 p.m. local time. 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 the Preventative maintenance period and 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.

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:

3.2.2.1.1. date and time notified

3.2.2.1.2. date and time of arrival

3.2.2.1.3. serial number, type and model number of equipment

3.2.2.1.4. time spent on repair(s), and

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

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

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

The Contractor shall provide, install, maintain, and repair through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. UPSs with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, deionizers, filters, preventative maintenance and repair, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, validation materials, tables/stands, etc.

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.

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.

3.3. Training

The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. Training shall be provided on the operation of the system, data manipulation, and basic trouble shooting and repair.

In addition, operator training shall be provided by Contractor on-site for all operators on all shifts (day shift: 0700 – 1530, evening shift: 1500 – 2330 and midnight: 2300 – 0730), as applicable.

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

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

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

3.3.1. 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:

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

3.3.1.1.2. Waste ignitability (Reference 40 CFR §261.21)

3.3.1.1.3. Waste corrosivity (Reference 40 CFR §261.22)

3.3.1.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

3.3.1.1.7. Solid Waste (Reference 40 CFR §261.2)

3.3.1.1.8. Exclusions (Reference 40 CFR §261.4)

The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

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 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 Contractor response:

3.3.1.1.22. pH

3.3.1.1.23. Flash point (to higher than 200F)

3.3.1.1.24. BOD; biochemical oxygen demand

3.3.2. 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 the waste from each device can legally be disposed of via the sewerage system.

4. SPECIAL REQUIREMENTS

4.1. Physical Security and Facility Considerations

4.1.1. Identification, Parking, Smoking and VA Regulations (For any onsite services): 5.1.1.1 The Contractor employees and/or Subcontractors (collectively “Contractor personnel”) shall always wear visible identification while on the premises of the facilities within the VISN. Identification shall include a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor personnel shall maintain a professional appearance commensurate to their industry.

Contractor personnel shall park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VA is not liable for parking violations of Contractor personnel under any conditions.

Any interior or exterior doors that are 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 for taking 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 should 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 personnel to contractual and other legal remedies.

The Contractor personnel must register with OR TRAXX for vendor management.

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.

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

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.

The Contractor shall not allow its personnel 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.

4.2. Information Technology Security Considerations

4.2.1. Contractor shall 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 or its subcontractors 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, all of which are incorporated herein by reference. 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 completion or termination of the Contract.

4.2.2. System management middleware that is intuitive, provides direct operations control (e.g. over reflex testing), allows for a real test count, and allows for auto verification at the system level as required by the facility or LIS capability.

4.2.3. 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, which is incorporated by reference herein, upon: (i) completion or termination of the Contract or (ii) disposal or return of the IT equipment by the Contractor or any person acting on behalf of the Contractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractor that contain VA information must be returned to the VA for sanitization or destruction, or the Contractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of completion or termination of the Contract.

4.2.4. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for Contractor to remove and the VA to retain the electronic storage, then the equipment contractor must have an existing BAA if the device being traded in has sensitive information stored on it and electronic storage media from the system are being returned physically intact; and any fixed electronic storage media on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is required using VA approved and validated overwriting technologies/methods/tools.

4.2.5. Contractor shall comply with all terms and conditions of VA Handbook 6500.6 Section C and VA Directive 6550.

Records Management

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

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

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

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

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

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

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

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

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

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

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

VA HANDBOOK 6500.6 APPENDIX C

MARCH 12, 2010

C-10

3. TRAINING

a. 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:

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

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(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.]

b. The contractor shall provide to the contracting officer and/or the COTR 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.

c. 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.