Active

Contract Opportunity

Procurement Technical Assistance Centers (PTACs) are an official government contracting resource for small businesses. Find your local PTAC (opens in new window) for free government expertise related to contract opportunities.

This is a notice of intent to sole source a contract under the authority of FAR 13.106-1(b)(2), only one source being available to meet the Government s need.
The North American Industrial Classification System (NAICS) code for this procurement is 325413, In-Vitro Diagnostic Substance Manufacturing, with a small business size standard of 1250 Employees. The FSC/PSC is 6515, Medical and Surgical Instruments, Equipment, and Supplies.
The Department of Veterans Affairs intends to solicit and award a sole source contract for Vitek Microbiology cost per test analysis services to Biomerieux, Inc, 100 Rodolphe St. Durham NC 27712. There are no other sources of supply/service that will satisfy agency requirements.
REQUIREMENTS/SCOPE: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this SOW, perform all the required tests described within this solicitation, and 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).

SPECIFIC TASKS:
Equipment shall maintain, or preferably reduce the number of workstations and/or overall labor required to accomplish the required testing by each laboratory.

The Contractor shall 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 of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy. Expiration dates shall be clearly marked on reagents, 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.

Primary analyzer(s) Base equipment offered 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 the technical specifications of this solicitation. If a backup analyzer is required, the backup analyzer shall meet the technical functionality and the capabilities of the primary analyzer, to include additional analyzer(s) that meet the definition of a primary analyzer.

Operational Features - The instrumentation offered shall have the following, at a minimum:
The capability of performing analysis on 100% of the test panels listed.
Sufficient capacity and throughput to meet the volume and service demands as defined in list.
Safety features to avoid exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal through the use of sealed consumables.
A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be included and immediately available for implementation to the VA computerized hospital information system.
The accuracy of the barcode reading shall have less than a 1% failure rate.
Equipment shall be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.
Equipment shall accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric, depending on the facility.
Minimal daily, monthly, and periodic maintenance.
Ability to store and retransmit records twenty-four (24) hours of maximal instrument throughput) in case of interface outage.

Technical Features - The instrumentation shall be approved by the FDA and shall have the following, at a minimum:

The capability of accurately and reliably identifying gram-negative and gram-positive bacteria, yeast, and anaerobes 90 99% of the time.
The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. At a minimum, the equipment shall provide Minimum Inhibitory Concentrations (MIC) values for the following antibiotic-organism combinations in B.3.4.d.iii.
A list of current needs include:
The information below shall be updated as new versions of standards are released:

0.45% NACL SALINE BAG/CASE
0.45% SALINE 1000ml Bottle/CASE
2mm x 75mm POLYSTYRENE TUBES
ACCESSORY KIT VITK2 PIP/DIL
KIT DENSICHEK PLUS STANDARDS
GN TEST KIT VTK2
GP TEST KIT VTK2
YST TEST KIT VTK2
NH TEST KIT VTK2
ANC TEST KIT VTK2
AST-GP TEST KIT
AST-ST02 TEST KIT
AST-GN TEST KIT
AST-XN TEST KIT

The capability of detecting emerging antimicrobial resistance.
MRSA (Methicillin Resistance Staphylococcus aureus, VRE (Vancomycin Resistant Enterococcus, ESBL (Extended Spectrum Beta Lactamase), KPC (Klebsiella pneumonia Carbapenemase), and others as they arise.
Comprehensive and extensive database of bacteria and yeast species that is consistent with FDA/CLSI guidelines.
Software or equipment modifications, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC), and other governing or authoritative bodies. Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades.

The platform shall be able to increase throughput by connecting the two machines together.
The included middleware shall include, as a standard, the ability for continuous remote notification of critical events, and delayed processing steps.
The included middleware shall be able to manage multiple instruments through a unified interface.

Comprehensive array of bacterial antimicrobial susceptibility panels Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions and limitations for their methodology at time of quote.
Built-in quality control program to continuously monitor system performance.

Data Management - The System shall have the following, at a minimum:
Capability to provide varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles, i.e. using conditional statements (if/then statements), that all search and retrieval of specific information (by patient, by organism, by antimicrobial agent, by specimen type, by MIC, etc.)
Conditional statements shall also allow for modification of reporting/not reporting selected antimicrobial agents by enabling/disabling suppression rules.
Capability to connect to the Veterans Health Information Systems and Technology Architecture (VISTA) interface.
The Contractor shall supply IT personnel support to implement VISTA verification from the supplied equipment middleware interface upon installation of the instrumentation.
Capability to record, store, and print the following information:
Manufacturer required quality control and instrument maintenance information.
Patient demographic information and specimen results
Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms (with the option of first-isolate antibiograms), organism trending report, phenotype occurrence report, etc.
Sufficient memory to store patient information and test results with downloading capability to an encrypted/password-protected external hard drive, thumb drive, or equivalent medium for long-term storage of patient records and other information.

Hardware Features - The instrumentation shall have the following, at a minimum:
A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.
An on-board monitor/screen that is easily readable.
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).
An uninterruptible power supply with line conditioner for each instrument provided.

Support Features
Commercial marketing. The equipment models being quoted shall be in current production as of the date this quote is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being quoted as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Gray market equipment, supplies, reagents are not acceptable.
Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing.
Training. The Contractor shall provide an off-site instrument training program for up to two operators initially that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and equivalent to a training program that the Contractor provides in the commercial market. This shall include, but is not limited to, training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

Service Requirements
A technical assistance center shall be available by telephone twenty-four (24) hours per day, seven (7) days per week with a maximum call back response time of one (1) hour.
Equipment repair service shall be provided on site during core business hours between 8 AM and 5 PM within twenty-four (24) hours. If equipment malfunction is deemed to jeopardize the need for continuation of patient care, then the Contractor will provide an emergent on-site repair service to be conducted outside routine business hours within twenty-four (24) hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.
Equipment repair response time shall be no more than two (2) hours.
Preventative maintenance will be performed on all primary and back-up instrumentation and any incremental support equipment as frequently as published in manufacturer s operator s manual and within two (2) weeks of the scheduled due date.
A malfunction incident report shall be furnished to each facility 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
Upgrades. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system, 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 quoted, i.e. new version of software, expanded database, 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 includes replacing the original piece of equipment provided under the BPA if the new equipment is deemed superior by the receiving facility and results in significant changes in the hardware operational capability.

Ancillary support equipment. The Contractor shall provide, install and maintain through the life of the BPA, 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.

The Contractor shall be responsible for moving the quoted instrumentation/equipment in the event of facility renovation, or as needed by the VA, for the term of the BPA and subsequent Delivery Orders.

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 CSLI 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 shall 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.

The Contractor shall provide a description of all wastes that 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, corrosiveness, 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:
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 VAHS 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.

Implementation/transition timeframe. The implementation of the services/requirements described in this solicitation shall be completed no later than 30 days after the award of the BPA. 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 30 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 BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through [TBD] days. 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. Contractor s submitted plan shall not exceed [TBD] days for the transition of all services under the awarded BPA 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 BPA for cause under the Termination for Cause clause of the BPA.
At the end of [TBD] days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

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 BPA] 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 after the installation date, equipment verification, and after the written acceptance by the VA that the equipment can perform the requirements stated within this solicitation. It shall end when the equipment has met the standard of performance for a period of thirty (30) consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in any BPA at an effectiveness level of 90% or more.

In the event that equipment does not meet the standard of performance during the initial thirty (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 thirty (30) consecutive days.

If the equipment fails to meet the standard of performance after sixty (60) 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 Part 52.212-4 entitled Termination for Cause. (The Contractor shall receive revenue for tests reported during the ninety (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 one-hundred (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 one-hundred (100) hours.
The Government shall maintain daily records to satisfy the requirements of this paragraph 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 BPA, 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 POC 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.
Any responsible source that feels it is capable in performing this requirement may submit a quote for the above listed items and describe and/or submit documentation to support your capabilities. The response will be considered by the agency. If you are not the Original Equipment Manufacturer (OEM), you must submit an authorized distributor letter signed by the OEM. If you are not the OEM and a small business, you must indicate in your response how you will comply with limitations on subcontracting and/or the non-manufacturer rule. Responses should be submitted to Shelley Self at Shelley.Self2@va.gov no later than September 11, 2023, at 12:00 PM PST to be considered. If no responses are received, the Government will continue with its sole source procurement, and a sole source Request for Quote will be published to contract opportunities in accordance with FAR 5.102.

Attachments/Links