7A21--VISN Wide Lab Subscription

Active

Contract Opportunity

DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Sources Sought Notice (SSN) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this SSN.

1. Title: Laboratory Statistical Analysis Software - VISN 16 medical center and outpatient clinic laboratories

2. Purpose: Under the single VISN procurement, contractor shall provide 8 base network license and 25 additional user license subscription renewals for EP Evaluator Standard Version Release 12 Clinical Laboratory Statistical Analysis software or newer or equal. Subscription renewals for each site shall allow for continued concurrent use up to the total number of licenses purchased for a respective site. An EP Evaluator subscription renewal code for each site subscription shall be provided electronically to the VISN Clinical Systems Program Office for distribution to the respective laboratories. Each license has a subscription period of one year to begin on December 16, 2024, and end December 15, 2025. The commercial off the shelf subscription will include use of the existing software, contractor provided technical support, contractor provided product support, upgrades and updates for the entire period of performance. The contractor shall provide technical troubleshooting, report assistance, and software upgrades without additional charges. Subscription shall also provide electronic access to previously entered data and saved reports for historical purposes. Technical support shall be provided by email or telephone, Monday through Friday, excluding holidays from 9 am to 8 pm EST/EDT. Contractor provided support includes troubleshooting and technical (clinical) assay performance evaluation assistance by a clinical chemist or equivalent. Upgrades and updates will be provided via CD or HTML download, as applicable. The software is loaded on laboratory PCs (by local OI&T staff) that are connected to the network. The software is not installed on any laboratory equipment, nor will it contain/collect any personally identifiable or protected health information. The raw data is entered into the statistical analysis report by the laboratory technologist or imported from spreadsheets. Contractor will not be on site or access the VA network in any way. All contractor support is provided via telephone/email.

EP Evaluator version 12 statistical analysis commercial off the shelf software or equal should have VA TRM approval. Subscription shall support full product functionality. The commercial off the shelf product shall perform statistical analyses necessary to accomplish the functions listed below for clinical laboratories as required by accrediting agencies to include The College of American Pathologists (CAP), The Joint Commission on Laboratory Accreditation (TJC), the Clinical Laboratory Improvement Act of 1988 (CLIA) and VHA Handbook 1106:
Performance of method comparison analysis for quantitative, semi-quantitative and qualitative assays between laboratory instruments (between 2 instruments and between multiple instruments) and correlations between laboratory and point of care equipment for both new and existing test methods (includes calculation of Accuracy, Precision, Linearity, Carryover, Sensitivity (Limits of Blank and Limits of Quantitation)
Calculates/Validates the International Normalized Ratio (INR) calculation, establishes geometric means, manual INR check and determines Factor Sensitivity for coagulation assays
Calibration Verification statistical analysis
Statistical analysis to establish and/or verify reference/normal ranges
Analysis/evaluation of assay carryover, interference and checks assay bias
Offers functionality to track laboratory cost per test
Offers functionality to maintain an incident tracking log
Offers functionality to support inventory management of reagents, controls, calibrators, etc.
Offers functionality to track and maintain competency assessment of technologists and technicians, and phlebotomists as well as nursing staff for the ancillary testing programs,
Offers Histogram and Descriptive Stats
Composite Reporting
Six Sigma Metrics
Provides professional reports, that are ready to review, sign and file in accordance with clinical laboratory accreditation requirements.
Definition of user groups to control access to specific projects/data.
Built-in backup and restore.
Help User Guide has been consolidated and the entire guide is also available on line.
Implements the following Clinical and Laboratory Standards Institute (CLSI) protocols:
EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline
EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
EP9-A, Method Comparison and Bias Estimation using Patient Samples; Approved Guideline
EP9-A3, in addition to EP9-A in previous editions, EP version 12 provides an advanced option for method comparison and incorporates an updated outlier detection algorithm.
EP12-A, User Protocol for Evaluation of Qualitative Test Performance--Approved Guideline
C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline
GP10-A, Assessment of the Clinical Accuracy of Laboratory Tests using Receiver Operating Characteristic (ROC) Plots; Approved Guideline
EP10-A, Preliminary Evaluation of Clinical Chemistry Methods; Approved Guideline
EP7-A, Interference Testing in Clinical Chemistry--Approved Guideline

ED-EE-S-NET-SU Single User Network license provides renewals for the following VAMC Labs:
Alexandria VAMC
Biloxi VAMC
Fayetteville VAMC
Houston VAMC
Jackson VAMC
Little Rock VAMC
New Orleans VAMC
Shreveport VAMC

ED-EE-S-ADD Network License Additional User provides renewals for the following Clinic Labs:
Lafayette OPC
Joint Ambulatory Care Clinic (JACC), Eglin, Mobile, and Panama City OPCs
Branson, Ft. Smith, Joplin, and Springfield OPCs
Beaumont, Conroe, Lufkin, Katy, and Tomball OPCs
Conway, Searcy, Russellville, El Dorado, and Hot Springs OPCs
Baton Rouge OPC
The anticipated Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code 513210 is $41 M.

3. Responses Requested: The following questions must be answered in response to this SSN.
Answers that are not provided shall be considered non-responsive to the SSN:

a. Where are the requested items/equipment manufactured?

Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice

b. Are the requested items/equipment manufactured by a Small or Large business? Is the potential vendor in compliance with the Non-Manufacturer Rule (NMR)?

Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice

c. Is the Vendor an authorized distributor with access to Original Equipment Manufacturer (OEM) parts, services and upgrades which may be required in performance of this requirement?

The VA does not accept grey market items and therefore the Vendor must attach evidence of this access (Authorized Distributor letter) to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice. Distributors shall also provide written evidence of software developer/manufacturer provision of all services required including contractor provided technical support, contractor provided product support, contractor provided troubleshooting as well as contractor provider upgrades and updates without additional charge.
d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following:

Point(s) of contact name: _______________________________________________
Address: ___________________________________________________
Telephone number: ___________________________________________
Email address: _______________________________________________

Company's business size: ________________________________________________
Data Universal Numbering System (DUNS) #: _______________________________

e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite NAICS code 513210?

Please provide proof of qualifications.

f. Is your company available under any Government Wide Agency Contract (GWAC), General
Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or
Blanket Purchase Agreement (BPA)?

If so, please identify the contract number for the Government to review as part of this Market Research.

4. Opportunity/Market Pricing: The VAMC is seeking information from potential vendors on their ability to provide the required items/equipment and support. THIS IS A SOURCES SOUGHT NOTICE ONLY. Small Business Concerns are encouraged to provide responses to this SSN in order to assist the VAMC in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation.

5. Instructions and Response Guidelines: Questions regarding this SSN shall be submitted no later than 1 pm (CST), Monday, November 4, 2024, via email to diyonne.williams@va.gov

SSN responses are due by 1 pm (CST), Monday, November 4, 2024; size is limited to 8.5 x 11 inches, 12-point font, with 1-inch margins in Microsoft Word format via email to diyonne.williams@va.gov The subject line shall read: Laboratory Statistical Analysis Software and its associated parts. NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 3(a) - 3(f).

Please provide the information you deem relevant in order to respond to the specific inquiries of the SSN. Information provided will be used solely by VAMC as Market Research and will not be released outside of the VAMC Purchasing and Contract Team.

7. Contact Information:

Diyonne Williams
DIYONNE.WILLIAMS@va.gov

Your response to this notice is greatly appreciated!

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