6640--Tissue Processors Lease, KC, 36C255-25-AP-0369

Description

This is an amendment to the solicaiton to answer vendor questions.

INTENT: Kansas City VA Medical Center needs to rent/leasing two (2) HistaCore Pegasus Dual Retort Tissue Processors to use in the preparation of tissue samples obtained from Veteran patients. This preparation is necessary to produce slides for review by Pathologists for diagnostic purposes.

REQUIREMENT: The instrumentation shall have the capability to diffuse solutions into biological specimens to ensure that proper embedding occur.

New equipment shall be acquired for the required laboratory. Refurbished, discontinued, or previously owned units are not acceptable. 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.

GENERAL REQUIREMENTS:

• Histacore Pegasus Dual Retort Tissue Processor
• Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements).
• Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and have the following
• Required Salient Characteristics
• Vacuum Infiltration Tissue Processor.
• Must be a floor standing model not to exceed the following dimensions:  32 x 28 x 61 inch (WidthxDepthxHeight).
• Must be moveable to allow access to serviceable parts for staff and service.
• Must have touchscreen interface.
• Must have a process capacity of up to at least 400 cassettes (blocks) per run.
• Must have the option run different protocols simultaneously on one instrument.
• Must provide the option for specimen tracking system that can record cassette ID and quantity, as well as user ID, in order to track tissues samples loaded.
• Must allow use of commercially available, nonproprietary brands of reagents and reagent substitutes.
• Must have reagent tracking system available to track reagent type and lot.
• Reagent reservoirs must allow easy access for changing of reagent solutions.
• Must have a reagent management system to allow rotation of solution groups for optimum processing. The reagent system should involve as little hands on as possible for safety (both employee exposure and specimen safety) reasons. For safety to include built in systems to minimize exposure to chemical fumes.
• Instrument must track reagent quality and concentration for optimal use.
• Instrument must automatically rotate reagents based on quality and concentration.
• Hot paraffin is exchanged without manual handling.
• Must be capable of holding up to 10 processing programs.
• Must have a battery back-up system (UPS) for electrical outages.
• Must have audible and visually displayed alarms for system malfunction.
• Must allow for delayed start and end times of processing with auto-calculation.
• Installation Requirements
• Vendor must supply the following items in sufficient quantities for initial operation.
• All reagent bottles with attachments and labels.
• Activated carbon filters.
• Metal cassette basket (baskets) with handles and dividers to complete up to a 300 cassette (block) run.
• Any necessary hoses.
• Any other parts and reagents needed to allow for immediate training and use after installation.  The Contractor is responsible for any missing parts and components not included in the order to carry out the installation.

Method Performance/Validation Requirements:

Method Performance/comparison shall be at the expense of the Contractor, shall include reagents and be consistent with current Clinical Laboratory Standard Institute (CLSI) guidelines, College of American Pathologists (CAP) standards and related Federal Regulations.

Support Features:

Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this contract. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies.  The Contractor shall perform all the statistical analysis provide a hardcopy of data in an organized, clearly comprehensible format.

Documentation: 

A current editable standard operating procedure shall be provided.

A printed, electronic copy or both, of the Operator’s manual and technical manual shall be provided.

The document(s) shall be formatted in accordance with current, approved CLSI guidelines. Electronic (CD Format).

At a minimum, electronic copies of Safety Data Sheets (SDS) shall also be provided. 

Updates to all procedure manuals in Microsoft Word format and SDS sheets in electronic format shall be provided when package inserts are modified.

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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. If applicable, off-site travel shall include the cost of airfare, room and board for each participant, if applicable.

Equipment Preventative Maintenance/Repair Service.

The Contractor shall be able to provide emergency equipment repair and preventative maintenance on instrumentation, and any incremental support/ancillary equipment, e.g., UPS, line conditioner, etc. offered according to the following terms:

Service Requirements

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 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(s).

Equipment repair service shall be provided during core business hours.  Core business hours are 8:00 AM to 5:00 PM.  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 on the same day or no more than 24 hours.

Service must be provided by a local technician 

A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call.  The report shall include, as a minimum, the following:

• Date and time notified
• Date and time of arrival
• Serial number, type, and model number of equipment
• Time spent for repair and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.
• Each notification for an emergency repair service call shall be treated as a separate and new service call.

Vendor will supply any parts necessary to keep the equipment operational.

If upgrades or changes in technology render a piece of equipment no longer necessary, contractor shall remove said piece at contractor’s expense.

Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software 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 contract; however, it does refer to significant changes in the hardware operational capability.

Ancillary Support Equipment - The Contractor shall provide, install and maintain 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. cabinetry to support/house the analyzer (if necessary), filters, preventative maintenance and repair, etc.), printers and universal interface equipment, UPS and UPS Batteries, line conditioners, 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.

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. 

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:

• 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 process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements.  At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented.  Any mercury containing reagents must be identified in any concentrations.  All test results shall be provided.  All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented.  For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

Barium             (Total)

Cadmium         (Total)

Chromium       (Total)

Copper            (Total)

Cyanide           (Total)

Lead                (Total)

Mercury           (Total)

Nickel              (Total)

Silver               (Total)

Zinc                 (Total)

Arsenic            (Total)

Selenium         (Total)

Tin                   (Total)

pH

Flash point      (to higher than 200°F)

BOD; biochemical oxygen demand

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.

Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the CONTRACT. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe.  Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. 

Upon award of a contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational by April 30 or mutually agreed upon date. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

Contractor shall provide with its quotation an implementation plan for installation of new equipment.  The plan should include 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 contract for cause under the Termination for Cause clause of the contract.

At the end of 120 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded CONTRACT.

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 contract] 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 of effectiveness of 90% or more.

If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

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.)

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.

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 more than the minimum of 100 hours.

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.

During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer 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. The same terms and conditions apply to ancillary/support equipment provided under this contract, i.e., water system UPS, etc.

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.

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.

As applicable, the Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract

As applicable, all electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction, or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the CONTRACT or disposal or return of the IT equipment, whichever is earlier.

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

• Contractor must accept the system without the drive;
• VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or
• VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

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;

The equipment Contractor must 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

Any fixed hard drive 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 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 contract.

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.