36C24420Q0502-001.docx

Purpose and Objectives: The intent of this Sources Sought Notice is to identify potential businesses especially any Small Businesses and SDVOSB offerors capable of providing Brand Name or Equal PCR HIV/HCV/HPV/COVID-19 Reagents and Supplies as listed in the Statement of Work/Description/Specifications and CLIN List. These are for the VA Medical Center in Pittsburgh, PA 15240. Responses to this Sources Sought Notice should demonstrate the firm's ability, capability, and responsibility to provide the principal components of supplies listed in the SOW and CLIN list.

Responses should include the following information:

1. Business name, address, Government Business Point of Contact, telephone number and email address.

2. Socio-economic Category and if they are a manufacturer or authorized distributor of the items.

3. Company DUNS number, CAGE Code, and Tax ID numbers.

4. If applicable Identify FSS/GSA contracts.

All information is to be submitted via e-mail at Amanda.Williams4@va.gov.

Information provided will not be returned. All responses shall be in the English Language. Responses are due by 3:00 pm (EST) on Thursday, April 16, 2020. No submissions will be accepted after this date and time. Questions can be submitted electronically at Amanda.Williams4@va.gov.

This is a Sources Sought Notice and submissions will be used for informational and planning purposes only. This notice does not constitute a formal Request for Quote (RFQ), nor is the government obligated to issue an RFQ. In addition, the Government does not intend to pay for any information provided under this notice. The Government is not obligated to notify respondents of the results of this survey.

Molecular PCR Statement of Work/Description/Specifications

1. Standard Requirements:

A. VA Pittsburgh Healthcare System has a need for instrumentation to perform automated real-time polymerase chain reaction (PCR) testing (also called molecular photocopying) to detect HIV, HCV, HPV, and COVID 19.

B. Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. The instrument must be new equipment. No remanufactured items. All items must be covered by manufacturer’s warranty.

C. Minimal instrument maintenance preferred with little to no maintenance parts to replace.

D. The instrument must be a contained system with procedures/processes that have less than an hour hands on technologist time due to staffing shortages. Minimal specimen pre-treatments/pipetting and specimen transfer are required.

E. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of workstations or overall labor required to accomplish the required testing.

F. The Contractor is required to 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 date must be clearly marked on reagent, 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. Ready to use reagents with no preparation are preferred.

G. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the regularly scheduled standing order/routine supplies delivery.

H. The testing instrumentation must be approved by the Food and Drug Administration (FDA) and be available on the on Contractor’s FSS Contract at the time of proposal submission I. Minimum of 380 results per 8-hour shift.

J. Automated contamination control and isolation of sample processing and transfer from each other and the general laboratory environment.

K. On board refrigeration is preferred.

L. Sample capability of at least 300 tubes on board.

M. Operational system must be at least Windows 7 with an upgrade to Windows 10 included as soon as available.

N. VA Pittsburgh will be a reference laboratory for VISN 4 Clinical Laboratories and other VAMCs for PCR testing including COVID 19 once available.

O. Must be able to perform Human Papilloma Virus (HPV) testing once FDA approved.

P. The analyzer must have 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 immediately available for implementation to the VA computerized hospital information system.

Q. The instrument must have a barcode reading accuracy rate of 99% or greater.

R. An instrument management system (internal to testing instrumentation) that provides/maintains and on-board QC data management system with minimum storage capacity of BBB QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data. Ability to monitor instrument performance. Minimal carryover is required.

S. 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.

T. 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.

U. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

V. Capability to capture, store and print patient demographic information and specimen results.

W. On board reagent inventory management system must provide 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). Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology is preferred.

X. On board reagent stability sufficient to accommodate both high and low volume use.

2. Vendor Information Requirements:

Vendor agrees to notify the COR of any changes to reagent composition, shipping delays or product recalls. Vendor will work with COR to schedule any required training or education. The vendor will provide any updates to safety data sheets (SDS).

3. Service/Support:

A. The vendor shall provide preventative maintenance at no additional charge B. The vendor shall provide field service repairs within 24 hours of being notified Mon-Fri 8a-5p if corrective actions can not be resolved by technologists via technical support C. The vendor shall provide technical support via telephone Mon-Fri 8a-5p D. The vendor must provide software updates at no additional charge within 30 days of availability

4. Government Furnished Property:

The government will furnish no property to the vendor.

5. Term of Contract/Delivery:

Delivery is intended to be as soon as possible due to COVID-19 Testing.

The Government intends to award a contract for a base year and four (4) option years.

The base year shall start on or before 08/01/2020 and the specific period of performance will be determined depending on delivery time frame. No materials shall be sent by the contractor after the end date until the Contracting Officer authorizes such services in writing.

6. Legal Requirements Related to Medical Records/Privacy And Confidentiality:

E. Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security, use, and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).

F. Records created by the Contractor in the course of treating patients under this contract are the property of VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.

G. The treatment and administrative patient records created by, or provided to, the Contractor under this contract are covered by the VA system of records entitled “Patient Medical Records – VA” (24VA19), which is available at http://www.rms.oit.va.gov/SOR_Records/24VA19.asp

H. The Contractor is required to comply with Title 48 of the Code of Federal Regulations, Part 24.101-24.104 “Protection of Privacy and Freedom of Information”. When responding to a veteran’s request that copies of records is released to a third party, the Contractor shall refer the veteran to VA for release of records. The Contractor is responsible for complying with VHA, Joint Commission, HIPAA, and other applicable external regulatory agency regulations.

I. Neither the VA nor the Contractor has the legal authority to require that a patient provide his/her Social Security Number to the VA as a condition for receiving medical care under Title 38, United States Code. If the patient does not provide a Social Security Number, the VA will assign a unique identification number to the patient.

7. Delivery Location

· Items are to be delivered to the shipping dock at:

Attn: Erin Palmer

2NW101-1-UD

8. Contract Administration: Designation of Contracting Officer Representative (COR)

Jason C. Tedrow is designated as the COR in monitoring and certifying as to the receipt of services rendered under this contract. A formal Delegation letter outlining the responsibilities of the COR will be sent after award of contract.

Name: Jason C. Tedrow Title: Lead Medical Technologist Email: Jason.Tedrow2@va.gov

BRAND NAME OR EQUAL TO THE FOLLOW CLINS

ITEM INFORMATION

Cobas 6800

HIV-1 quant. (cobasR 6800 / 8800 assays)

LOCAL STOCK NUMBER: 6998798190

HCV quant. (cobasr 6800 / 8800 assays)

LOCAL STOCK NUMBER: 6998836190

cobas omni Amplification Plate

LOCAL STOCK NUMBER: 5534941001

cobas omni Pipette Tips

LOCAL STOCK NUMBER: 5534925001

cobas omni Processing Plate

LOCAL STOCK NUMBER: 5534917001

KIT COBAS 6800/8800 LYS REAGENT IVD

LOCAL STOCK NUMBER: 6997538190

KIT COBAS 6800/8800 MGP IVD

LOCAL STOCK NUMBER: 6997546190

KIT COBAS 6800/8800 SPEC DIL REAGENT IVD

LOCAL STOCK NUMBER: 6997511190

KIT COBAS 6800/8800 WASH IVD

LOCAL STOCK NUMBER: 6997503190

KIT COBAS 6800/8800 NHP NEG RMC IVD

LOCAL STOCK NUMBER: 7002220190

KIT COBAS HBV/HCV/HIV-1 CONTROL US-IVD

LOCAL STOCK NUMBER: 6998887190