G
The analyzer unit shall be capable of handling a daily throughput of the following quantities:
Test Qty.
CT 250
GC 250
TV 10
HPV 80
HPV 16/18 10
a) The analyzer unit shall be a fully automated, random access robotic system.
b) The analyzer unit shall be capable of analyzing nucleic acids from male and female urine samples, endocervical samples, vaginal samples, and male urethral swabs.
c) The analyzer unit shall utilize Food and Drug Administration (FDA)-approved tests to test for CT, GC, TV, and HPV.
d) The analyzer unit shall be capable of conducting FDA-approved assays for HPV Genotype 16 and HPV Genotype 18.
e) The analyzer unit shall be FDA-approved for testing female gynecological specimens collected in ThinPrep Pap Test vials containing PreservCyst solution.
f) The analyzer unit shall be capable of simultaneously testing for the presence of CT, GC, TV, and HPV in the same sample.
g) The analyzer unit shall utilize nucleic acid amplification testing (NAAT) technology to perform simultaneous amplification and detection of target DNA or rRNA for CT, GC, TV, and E6/E7 mRNA for HPV.
h) The analyzer shall be a single platform able to sample directly from patient collection tubes without removing caps, able to automatically dispense all reagents, and able to perform all automated steps for NAAT.
i) The analyzer shall be capable of performing the following procedures: sample preparation, separation suspension, reagent preparation, hybridization, separation, and detection.
j) Specimen flow from start to finish shall be fully-automated to include waste collection.
k) The analyzer shall be able to read Code 39 barcodes.
l) The analyzer shall be capable of specimen storage stability of at least seven (7) days in a transport container for urine and swab samples stored at a minimum range of 2ºC to 30ºC.
m) Samples shall be able to be kept at -20ºC for up to 90 days if the time of transport/storage exceeds 30 days.
n) The analyzer unit shall have integrated software that allows for on-board maintenance/error code generation and automated troubleshooting procedures.
o) The software shall document procedures.
p) The analyzer unit shall bi-directionally interface with the Composite Health Care System (CHCS) and with the laboratory information system (LIS). If the vendor is not already approved to connect to CHCS bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government. Interface integration must be completed prior to final acceptance of the system.
q) The analyzer unit shall meet the performance characteristics for accuracy, safety, and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA).
r) The units shall include an uninterruptable power supply (UPS) capable of providing all necessary electrical power to each analyzer.
s) The power requirements is 120 V, 60Hz.
The vendor shall provide installation, validation testing, user training, and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies, and establishment of initial control ranges using control materials.
Corrective system maintenance coverage shall occur Monday through Friday from 0730-1700 local time, excluding Federal Government holidays as seen at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. This includes annually required preventive maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week. Training shall be provided by the vendor. The vendor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a period of performance from 01 October 2019 to 30 September 2020, with four (4) subsequent one-year option periods.
Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.
Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.
The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.
There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334516. This RFI is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Derek Bell at [email protected]. Closing date for information is no later than 9:00 AM ET on 11 March 2019. No phone calls will be accepted.