Automated Autoimmune Immunoassay CPRR/CPT
SOURCES SOUGHT SYNOPSIS
The Department of Veterans Affairs is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in, and the resources to support, a requirement for a multiplexed Automated Autoimmune Immunoassay of patient samples to include FDA approved instrumentation and reagents to include supplies on a cost per test or cost per reportable result basis for the Edward J. Hines Jr VA Hospital, Hines, IL. The results of this market research will contribute to determining the method of procurement.
The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334516-Analytical Laboratory Instrument Manufacturing.
THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals/quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.
If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability.
The government will evaluate market information to ascertain potential market capacity to provide services consistent in scope and scale with those described in this notice and otherwise anticipated.
BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.
Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 12:00 PM CST on 26 April, 2018. All responses under this Sources Sought Notice must be emailed to jessica.rasmussen3@va.gov.
Below are a list of capabilities and requirements :
PERIOD OF PERFORMANCE
The anticipated period of performance would be a base period with four option years or a total of a 5-year ordering period.
SCOPE
Contractor must have FDA approved instrumentation and reagents for automated autoimmune immunoassay to include supplies.
The capability of performing random access analysis of the tests listed in the test menu using multiplexing technology. Total time to analyze a single test must be less than 2 hours. The analyzer must offer sufficient capacity and throughput to meet the volume and service demands defined in the test menu on a single eight-hour shift, Monday through Friday.
A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA computerized hospital information system-
Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.
Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha-numeric.
A barcode reading accuracy rate of 99% or greater.
An instrument management system (internal to testing instrumentation) that provides/maintains the following:
On-board QC data management system with minimum storage capacity of 34 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data, preferably to the Bio-Rad Unity Real Time data management system.
Ability to monitor instrument performance.
Continuous monitoring of vital instrument functions with immediate operator notification of failure(s). A record(s) of the vital instrument function failure(s) must be maintained and stored electronically on-board the equipment.
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.
Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.
Capability to capture, store and print the following information:
Instrument maintenance information.
Patient demographic information, minimally including patient name and UID.
Specimen results.
On board reagent inventory management system must have:
A system that provides reagent data to include but not limited to lot number, expiration date, and the number of remaining tests available for use on the analyzer (per analyte).
Barcoding of reagents and the ability to track reagent containers throughout the testing process through the use of barcode technology.
The ability to detect and alert operator of low liquid levels and the potential of depletion.
The capabilities to store, print, and retrieve calibration data.
The ability to continuously load patient specimens.
Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.
Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.
Minimal carryover.
Long calibration stability of at least one week.
Hardware Features- The instrumentation must have the following:
All monitors/screens will clearly display information in all light conditions.
A printer(s) 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). Replacement printers must be provided by the vendor at no additional cost for the duration of this agreement.
An uninterruptible power supply (UPS) with line conditioner for each instrument provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. Replacement UPS must be provided by the vendor at no additional cost for the duration of this agreement.
Specific Equipment Requirements-
Patient testing is disabled if QA failure occurs.
The technology to print results in real time or on demand
Method Performance/Validation Rerquirements-
Method performance/comparison at the expense of the contractor and include linearity material and reagents, consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. All studies performed must be appropriate for the test menu of the respective laboratory to include serum, plasma, urine, and body fluids, as applicable. These validation requirements are applicable to all new testing analyzers.
Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, must be run comparing the present and the proposed method. IN system where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor must be capable of analyzing results and providing statistical data to support acceptance of the new method for above studies. Statistics must consist of at least: mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current CLSI standards.
Carryover studies
Specificity studies
Analytical Measurement Range Validation
Precision study using normal and abnormal control material
Sensitivity
Reference Range- A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols must be used:
A verification of the manufacturer s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer must provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals must be used to verify the manufacturer s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.
If the suggested manufacturer s range is not appropriate for the patient population, a reference range must be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.
If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.
Reports- The Contractor must provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports must be used to monitor the commitment of each facility, reporting the savings realized and must be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) must not be accepted. There will be no additional charges for any reports required as part of the BPA. These reports will be in an Excel spreadsheet.
Support Features-
Commercial marketing. The equipment models being offered must be in current production as of the date this offer is submitted. For purposes of this solicitation, current production must 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.
Start-Up Reagents. The Contractor must be capable of providing all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment.
The Contractor must be able to perform/assist, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government.
The Contractor must be capable of performing all of the statistical analysis as stated in the Method Performance/Validation section above and provide a hard-copy of data in an organized, clearly comprehensible format.
Training. The Contractor must be capable of providing 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 must include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor must 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 must be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel must include the cost of airfare and room and board for each participant.
In addition to the training above the following must be provided:
Basic operator training must be provided by Contractor on-site for all operators on all shifts, as applicable.
Advanced training must be provided on instrument troubleshooting.
Equipment Preventative Maintenance/Repair Service. The Contractor must be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, etc. offered according to the following terms:
Service requirements
Preventative maintenance as required by manufacturer s operator s manual
Provide technical assistance center with availability by telephone 24 hours per day, 7 days a week with maximum call back response time of 1 hour.
Equipment repair service during core business hours, Monday-Friday, 7:30am-4:00pm or more often as required by the VA within reason.
Equipment repair response no more than 24 hours
Upgrades - The Contractor must 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 must 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; however, it does refer to significant changes in the hardware operational capability.
Ancillary support equipment - The Contractor must 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, preventative maintenance and repair, etc.), printers and universal interface equipment, etc. In addition, the Contractor must include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.
Interface Requirements-
Provide all hardware required for connect, implementation, and operation of the interface to the universal interface and any incremental fee required.
All necessary software support for insuring successful interfacing via Data Innovations instrument manager is established.
If a site does not have a universal interface and one is needed to optimally interface the instrument the contractor will be required to acquire one along with any other equipment necessary to connect to VA computerized hospital information system.
Commercial offerings - The Contractor must 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.
Implementation-
Capable of instrument implementation within 60 days of an award.
Test Menu-
Contractor instrumentation must include capabilities for the following tests:
Analyte
Estimated Annual Volume of Tests
ANA EIA Screen
5774
Anti-dsDNA
263
Anti SS-A
617
Anti SS-B
617
Anti-Sm
367
Anti-SmRNP
367
Anti-Scl-70
218
Anti-Jo-1
145
Anti-Centromere
59
P-ANCA (MPO)
807
C-ANCA (PR3)
807
Anti-GBM
77
Anti CCP
1030
Gliadin IgG
371
tTG IgG
579
Gliadin IgA
371
tTG IgA
579
Cardiolipin IgG
270
Cardiolipin IgA
48
B2GP1 IgG
255
B2GP1 IgA
255
Cardiolipin IgM
269
B2GP1 IgM
255
Measles
3054
Rubella
2281
Mumps
2747
Varicella Zoster
1132
Jessica L Rasmussen
Contracting Officer
920-431-2500 x72720
Jessica.rasmussen3@va.gov
