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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 12, 2017 FBO #5710
DOCUMENT

65 -- Polymerase Chain Reaction (PCR) Molecular Diagnostics - Attachment

Notice Date

7/10/2017
 

Notice Type

Attachment
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
 

ZIP Code

10468-3904
 

Solicitation Number

VA24217N0856
 

Response Due

7/24/2017
 

Archive Date

10/22/2017
 

Point of Contact

Delfo Saco-mizhquiri
 

Small Business Set-Aside

N/A
 

Description

STATEMENT OF WORK Polymerase Chain Reaction (PCR) Molecular Diagnostics Introduction and Scope of Work Molecular Diagnostics laboratories, Veterans Affairs Medical Centers VISN 2 South, require a Polymerase Chain Reaction (PCR) Molecular Diagnostics Testing Platform that enables a comprehensive menu of tests inclusive of tests depicted in the Workload Data table. A single analyzer platform is preferred, space availability, and cost savings. The sensitivity and specificity of each assay should yield at least a 95% confidence interval. The selected analyzer will be used for PCR testing in Bronx, Brooklyn, Manhattan and Northport VA Medical Centers. Each site may elect to perform all assays or a desired number of assays. This contract will be for one year. The contractor shall provide the analyzer, tests, equipment maintenance and service, and all supplies to the Medical Centers. Description of Services The Contractor shall provide all labor, equipment, uninterruptable power supply units, maintenance, material, reagents, consumables (specimen collection kits), tools, operational/maintenance manuals, upgrades, training, and parts necessary or incidental to furnish the equipment reagents and consumables for PCR Molecular Diagnostics, as further defined herein. We require the cost per reportable test to include sufficient reagents and materials to perform all patient testing, required monthly external quality control, lot to lot studies, proficiency testing challenges, and Calibration. We require a Service Contract for the equipment proposed. We require a set cutoff time for same day service, no later than 3:00 pm for same day service. We require the inclusion of all consumables in the cost per reportable test. This includes, but is not limited to patient collection kits required by the contractor to perform each assay. The VA agrees that it will not alter and/or modify any product loaned under this agreement in any manner without the express written permission of the Contractor. The VA agrees to operate the equipment in accordance with the applicable Operator s Manual provided by the Contractor. VA agrees not to misuse the equipment in any manner. Mandatory/FDA directed upgrades will be provided to the VA. In the event the Contractor develops other technological upgrades for the equipment the Contractor will supply the VA with the upgrades to replace the existing equipment. The VA Contracting Officer (CO) and Contracting Officer Representative (COR) will be notified in advance of such upgrade and a determination will be made by the facility if it is in the best interest of the government to accept the upgrade. If agreed to between the Contractor and the VA, then the existing equipment replaced by the upgrades shall be returned by the VA to the Contractor at the Contractor s expense within 30 days of the replacement. Instructions on the return shall be provided by the Contractor. This upgrade agreement will be effective for the complete period of performance of the contract. The Contractor agrees to repair and/or replace defective equipment as necessary at no expense to the Government. We will not accept remanufactured or used models. The contractor shall provide weight and dimensions of proposed analyzer. The footprint of the system should fit on a typical laboratory countertop otherwise an appropriate cart/table will be provided by the contractor at no charge. A list of the estimated yearly quantity by the participating facility will be provided. Quantities listed in the Statement of Work are estimates based on the projected and historical usage. Requirements The equipment must be Bi-Directionally Interfaced with the Veterans Affairs VISTA system, Cerner or other VA compatible software. The analyzer must be at least 95% accurate and reliable in performing PCR testing. Value added enhancements and/or upgrades without additional cost. The analyzer possess the ability to test for Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile with identification of 027 strain, Influenza A, B, RSV, H1N1, Chlamydia trachomatis/Neisseria gonorrhea, and Carbapenemase producing organism identification with differentiation among the major families of resistant genes. Also, if additional testing (new or reformulated) is available, those tests may be added to the testing menu. The analyzer possess Ease of Use. User friendly and walk-away capability (where applicable) that is not labor intensive and avoids unsafe aerosol producing steps including maintenance requirements. Ease of use includes minimum set up time, automated sample barcoding and minimal amount of time to perform daily, weekly and monthly maintenance. The software program must detect epidemic strains and is able to guide in problem solving. Barcode features should be associated with the equipment. Technical support by telephone must be offered 24 hours a day 7 days a week with a call back within 1 hour. Onsite technical field service representative must be provided same day if instrument is non-functional after trouble shooting fails and resolution is not achieved before the call-time cutoff (for example 3:00 pm for same-day service). If after defined cut-off time, we require onsite technical field service representative the following morning. Service Contract is to include, all labor, travel, and parts necessary to make repairs included in the cost per reportable test, with no additional charge for parts or labor. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed. Analytical/Measurement Aspects: Clearly define turn-around time for each test proposed. The contractor is to define the actual hands on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. At installation of new equipment, contractor will provide technical support to assist in equipment installation/set-up, and validation studies of data sufficient to meet CAP standards, CLSI and Federal Regulations. Instrument Performance/Comparison shall include but is not limited to: Accuracy studies for the assay, Precision studies, Specificity studies, Sensitivity studies, and Carryover studies, if applicable. Post Analytical/Reporting Requirements User Friendly Interface Instrument must have a VA approved interface. It is preferable if the interface has already been successfully implemented and is fully operational in a VA facility. Contractor must provide a continuous, on site hands-on training for users on the instrument and software as needed. Latest software must be user friendly and updated as soon as a new version is released at no cost to VA. Ability to interface with VISTA. Analyzer shall have the capability of providing printouts for all patient results and controls. Contractor Support Requirements Provides Clinical and Laboratory Standards Institute (CLSI) procedure on CD and on-line. Provides Uninterruptable Power Supply unit for each instrument and maintain it during the contract period. Provide FDA approved analyzer/equipment, reagents, controls, disposables, and any consumable part necessary for analyzing/testing. Contractor shall list the consumable parts provided. The contractor shall provide the validation kits and other necessary supplies to perform the validation of new tests/instrument at no cost to the participating facility. There shall be no cost incurred to any site for validation of any new assay or re-formulated assay during the contract period. Provide Technical Support at each site to perform/assist in method validation (correlation and precision studies) at each site. Provide a Training Plan defining the number of key operators that will be trained and the number of Training Specialists assigned to each site for training. Training must include but is not limited to the operation of the analyzer, quality control, interpretation and reporting of results, maintenance and trouble-shooting. We require on-site training for new and/or revised assays during the contract period. If training is available off-site, the contractor is to include all costs (transportation, room and board, etc.) for off-site training for the primary operator. Off-site training is preferred but not required. Instrument upgrade - If any upgraded equipment/software is produced during the term of the contract, the contractor will upgrade all equipment/software without an additional charge to the facility. Instrument and assays must be FDA approved. Contractor provides PM (preventative maintenance) according to manufacturer s specifications at contractor cost. If instrument is down for >72 hours contractor must replace instrument at no cost to VA. Contractor will provide the names and location of users in the area for site visits. Contractor will supply the same lot number for each quarter to each facility, to reduce cost of quality control. Contractor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and SDS s (also available in CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Estimated Yearly Quantity TEST NAME Bronx Northport NYHCS TOTAL TEST VOLUME MRSA 3,421 2,049 8,479 13,949 C. Difficile 505 325 905 1,735 Flu screening (A/B/RSV) 395 273 376 1,044 CT/NG 1,486 664 2,161 4,311 Carbapenemase Resistance 400 * 50 * 0 450 * *This is new in-house testing at the Bronx and Northport and NYHCS hasn t used it yet. An estimated amount for NYHCS will be provided with the solicitation. Delivery The awarded contractor must provide an implementation plan for delivery, installation, set-up, training and connectivity with VA systems to each VISN 2 facility within 30 days of award. Equipment and testing should be fully functional at all VISN 2 South facilities by January 1, 2017. Responses to this notice must be submitted in writing via email and must be received not later than Monday, July 24, 2017, 1:00pm EST. No telephone inquiries will be accepted. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, HUB Zone, 8(a), small business or large business). Responses to this notice will be used by the Government to make appropriate acquisition decisions. Responses to this notice should include company/individual name, a service capability statement, examples of similar facilities for which you have provided services to, proof of applicable certification. DUNS number, address, point of contact and social-economic category (ex: SBVOSB, VOSB, 8(a), HUBZone, WOSB, EDWOSB, Small Business). If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). Contractor must be registered in System for Award Management (SAM), formerly CCR (see internet site: http://www.sam.gov). Responses to this notice must be submitted in writing, and received not later than Monday, July 24, 2017, 1:00pm EST. All interested parties must respond to any related solicitation announcement separately from the responses to this announcement. Email: Delfo.Saco-mizhquiri@va.gov. No telephone inquiries will be accepted. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/VA24217N0856/listing.html)
 

Document(s)

Attachment
 

File Name: VA242-17-N-0856 VA242-17-N-0856.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3646287&FileName=VA242-17-N-0856-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3646287&FileName=VA242-17-N-0856-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04573189-W 20170712/170710235707-3fb642fd6413d687a496cb21255b32dd (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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