Attachment A - SOW (Specifications).docx

1. STATEMENT OF WORK/SPECIFICATIONS

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)- Base equipment offered that shall fully support the scope of operations (minimal requirements). The instrument shall be capable 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). The contractor shall identify if their test and specimen types are FDA approved.

1.1.2. Equipment: All equipment delivered to the participating medical centers 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 to current industry standards for such equipment is present in the current marketplace for Clinical urinalysis 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 Requirements:

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

The ability to use a variety of primary tubes sizes. No aliquoting necessary.

The ability to continuously load patients and controls and walk away.

Performs replicates using the same primary tube.

Results shall be fast and accurate, within 4 minutes.

Minimum sample volume required shall be 170uL.

The osmometer shall have built-in quality control software that includes statistical monitoring of daily QC, ability to set custom ranges, review Levey-Jennings charts, peer group data, 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.

The osmometer shall have accuracy of 0 – 400 mOsm: mean value ±3 mOsm/kg H2O from nominal value; 400 – 2000 mOsm: mean value ±0.75% from nominal value.

The osmometer shall have within run precision of 0 – 400 mOsm: standard deviation ≤ 3 mOsm/kg H2O; 400–2000 mOsm: CV≤ 0.75%.

Calibrations are to be stable per minimum JC 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.

Equipment shall accept, at minimum, 10 characters in specimen identifier that is alpha and/or numeric.

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 detect and alert operator of out-of-range quality control results via flagged results on QC printout and visual alerts on display monitor.

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 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.

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 in order 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 is 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 in order to complete autoverification 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.

Contractor must have existing VA MOU/ISA or agrees to establish an MOU/ISA upon award to provide remote monitoring and support meeting all VA Security Requirements. 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 to implement the remote support system.

1.4.3. Connectivity and Conformance

Contractor must have a Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA in sufficient time to meet the installation timeframes in section 3.

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

Contractor shall provide remote monitoring and support of the urinalysis 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 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.

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 or not 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 & PERIOD OF PERFORMANCE

3.1. Delivery: The Contractor shall deliver all urinalysis analyzers to participating VA medical facilities and CBOCs.

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. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation and any incremental support equipment offered according to the following terms:

Service Requirements- Equipment repair service shall be provided during core business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

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

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

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 for repair, and

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

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

3.2.3. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability.

3.2.4. 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.

The determination and description shall address the following:

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

3.2.4.1.2. Waste ignitability (Reference 40 CFR §261.21)

3.2.4.1.3. Waste corrosivity (Reference 40 CFR §261.22)

3.2.4.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

3.2.4.1.7. Solid Waste (Reference 40 CFR §261.2)

3.2.4.1.8. 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 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 Contractor response:

3.2.4.1.22. pH

3.2.4.1.23. Flash point (to higher than 200F)

3.2.4.1.24. BOD; biochemical oxygen demand

3.2.5. 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.

4. SPECIAL REQUIREMENTS (if applicable)

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 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 personnel to contractual and other legal remedies.

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 POC. The Contractor personnel shall also sign in and out each day at a designated location determined by the POC.

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.