36C24821Q0830.docx

Contract Opportunity Sources Sought Notice

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* = Required Field Contract Opportunity Sources Sought Notice Gynecologic, Non- Gynecologic & Urine Specimen Machine Hologic ThinPrep (or equal) 33744 36C24821Q0830 05-14-2021 13:00

EASTERN TIME, NEW YORK, USA

N 334516 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Room 315, Bldg. 2 10,000 Bay Pines Blvd Bay Pines FL 33744 Contracting Officer Janice Fornaro janice.fornaro@va.gov C.W. Bill Young VA Healthcare System 10,000 Bay Pines Boulevard Bay Pines, FL

33774

USA

THIS IS A SOURCES SOUGHT ANNOUNCEMENT ONLY

This is a sources sought notice only and it is not a solicitation announcement. The purpose of this sources sought notice is to gain knowledge of qualified, potential contractors and their socio-economic size classification in accordance with NAICS code 334516 (Analytical Laboratory Instrument Manufacturing). Responses will be used by the Government to make appropriate acquisition decisions. After a review of the responses to this sources sought notice, a solicitation announcement may be posted. A response to this sources sought notice is not an adequate reply to a potentially forthcoming solicitation.

The Department of Veterans Affairs, (NCO 08), C.W. Bill Young VA Healthcare System, 10,000 Bay Pines Boulevard, Bay Pines, Florida 33744 is seeking authorized Service Disabled Veteran Owned Small Business (SDVOSB’s), Veteran Owned Small Business (VOSB’s), Small Business (SB’s) or Large Business (LB’s) manufacturers/distributors that can provide a laboratory processor for gynecologic, non-gynecologic, and urine specimens (Pap Testing). Attached are the salient characteristics.

No reimbursement will be made for any costs associated with providing information in response to this Sources Sought and no contract will be directly awarded on the basis of this sources sought. Any information submitted by respondents to this Sources Sought shall be voluntary.

To respond to this sources sought notice, please complete the attached form titled “Response Form to Sources Sought Notice” and you may include a brief 1-2 page capabilities statement. Email the information requested to Janice Fornaro, Contracting Officer, at janice.fornaro@va.gov. Please reference “36C24821Q0830-Labortory Equipment” in the subject of the email. The closing date and time of this sources sought notice is May 14, 2021 at 1:00 PM Eastern Time.

This is not a solicitation and in no way obligates the Government to award any contract. Additionally, a response to this sources sought notice is not a request to be added to a prospective bidders list or to receive a copy of any forthcoming solicitation.

See attached documents: Response Form to Sources Sought Notice (Attachment A) Salient Characteristics (Attachment B)

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Procurement Sensitive Do Not Disclose----See FAR Subparts 2.101 and 3.104-4

Attachment A Response Form to Sources Sought Notice

Sources Sought Information and Capabilities for Laboratory Equipment

Please fully complete each section of the form below.

Company Name: _____________________________________________________________ Company Address: ___________________________________________________________ DUNS Number: _____________________________________________________________ Point of Contact: ____________________________________________________________ Phone Number: _____________________________________________________________ Email Address: _____________________________________________________________

(1) Is your company considered small under the NAICS code?

(3) Are you the manufacturer or distributor? What is the manufacturing country of origin of these items?

(4) If you’re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?

(5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract (e-CAT, etc)? If so, please provide the contract type and number.

(6) If you are an FSS GSA/NAC, e-CAT or NASA SEWP contract holder or other federal contract holder, are all the referenced items/solutions available on your schedule/contract and what is the contract number?

Socio-economic Classification in Accordance with NAICS code 334516 Analytical Laboratory Instrument Manufacturing (check all that apply)

☐ Small Business ☐ Service-Disabled Veteran Owned Small Business (SDVOSB) ☐ Verified SDVOSB by www.vip.vetbiz.gov ☐ Veteran Owned Small Business (VOSB) ☐ Verified VOSB by www.vip.vetbiz.gov ☐ Small Disadvantage Business ☐ Women-owned Small Business ☐ Economically Disadvantaged Small Business ☐ HUBZone ☐ 8(a) Certified ☐ Other: _________________________________________________

Detailed Information:

1. What percentage of the contracted services can your company complete as the prime contractor? ______________%

2. What percentage of the contracted services would your company subcontract? ______________%

3. Please attach your Company’s Capability Statement (1-2 pages maximum).

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Attachment B Salient Characteristics

Bay Pines VA Healthcare System

Brand Name or Equal Salient Characteristics for Hologic ThinPrep 5000 Processor for Gynecologic, Non-gynecologic, and Urine Specimen

Equipment: Hologic ThinPrep 5000 Processor (Part# 71362-001)

GENERAL REQUIREMENTS:

A. The ThinPrep 5000 Processor (or equal) must Include the following Components and Features:

1. Shall be a fully automated slide preparation, including automated capping and de-capping of machines/equipment vials, chain of custody verification and slides directly output into stainer-ready racks

2. Shall be a benchtop unit with Built-in touchscreen.

3. Must have an input carousel for up to 20 samples per batch.

4. Must include waste bottle

5. Must include fixative bath with staining rack

6. Must include filter waste bin

7. Must be able to check vial and slide Identification (ID)

8. Must be able to pick up the vial and filter

9. Must be able to deposit slides into the fixative bath

10. The processor must support the preparation of:

· Gynecologic specimens for use with the equipment’s Pap test, and subsequent imaging by the equipment’s Imaging System, or samples for gynecologic cytology screening.

· Must be able to collect non-gynecologic specimens for general cytologic screening.

· Must have urine specimens used in conjunction with the equipment’s Urine Collection Kit.

11. The dimensions must not exceed:

· Height – 40 inches

· Width – 40 inches

· Depth – 36 inches

12. Operating Temperature / Humidity must be:

· 16-32° C or 60-90° F

· 20%–80% RH, non-condensing

13. Must have power requirements – 100-130 VAC at 50-60 Hz, 240 Watts

B. Installation:

1. The vendor must provide installation support for the completion of all required validation documents / correlation studies CAP guidelines.

2. The Vendor must provide Standard Operating Procedures (SOP’s) for the instrument operation, quality control, and maintenance.

3. The Vendor must provide Safety Data Sheets (SDS) for all reagents, supplies, and consumables associated with the instrument operation.

C. Training:

1. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, and sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair.

2. Shall include the cost of the training program in the installation cost.

3. For off-site key operatory training (2 operators), the vendor must agree to pay all associated costs to attend the training (flight, baggage, lodging, meals, and transportation).

D. Upgrades: During the life cycle of the equipment, the Contractor shall provide to the Government all hardware and software upgrades i.e. new version of software, correction of hardware defect, etc., that are customarily provided to equivalent commercial customers at no cost to the Government.

E. Ancillary support equipment: The Contractor shall provide to the Government all ancillary components that are customarily provided to equivalent commercial customers with the model of equipment offered, including but not limited to, starter kits, LIS interface, automation track line connectivity.

F. Commercial Offerings: The Contractor shall provide the Government laboratories any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. template for writing standard operating procedures (SOPs), PC of their procedure / user manuals, an on-line procedure manual in the instrument software, training documents, competency sheets, validation protocols including documentation of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), test case scenarios and any other material necessary to comply with current Good Manufacturing Practice (cGMP) standards, etc.

G. Characterization of hazardous waste: The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

1. Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

2. Waste ignitability (Reference 40CFR261.21)

3. Waste corrosivity (Reference 40CFR261.22)

4. Waste reactivity (Reference 40CFR261.23)

5. Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31)

6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

H. Implementation/transition timeframe: The transition period for the awarded Contractor to have all instrumentation installed and operational is 90 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. It is preferred that at least 1 key operator attends training prior to the installation of the equipment.

I. Service: 1-year manufacturer included + 4 year extended service

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