36C24223Q1136.docx

Statement of Work VA New Jersey Health Care System – East Orange, NJ On-Site Surgical Instrument Repair Services Statement of Work VA New Jersey Health Care System – East Orange, NJ On-Site Surgical Instrument Repair Services

GENERAL INFORMATION

385 East Tremont Avenue

East Orange NJ

CONTACT INFORMATION

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

POINT OF CONTACT*

Contract Specialist Tiffany Vazquez-Simon tiffany.vazquez-simon@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

EMAIL DESCRIPTION

DESCRIPTION

On-Site Surgical Instrument Repair Services at VANJHCS East Orange VAMC 385 Tremont Avenue East Orange, NJ 07018

1. Action Code: THIS IS A PRE-SOLICITATION NOTICE

2. Date: 08/24/2023

3. Contracting Office Address: James J. Peters Bronx VA Medical Center 130 W. Kingsbridge Road Bronx, NY 10468

4. Classification Code: This procurement is classified as J066 – Maintenance, Repair, and Rebuilding of Equipment- Instruments and Laboratory Equipment

5. Important: This notice does not constitute a request for proposal, request for quote, or invitation for bid. The intent of this notice is to provide the pre-solicitation notice required by FAR 5.2- Synopsis of Proposed Contract Actions in preparation for release of the Request for Quote (RFQ) at a later date.

6. Description: The RFQ is planned to be issued on August 25, 2023. The Proposal due date is tentatively planned for September 15, 2023. The North American Industry Code Standard (NAICS) is 811210 – Electronic and Precision Equipment Repair and Maintenance, and the annual size standard is $34 Million. The planned procurement method is 100% Total Service-Disabled Veteran Owned Small Business (SDVOSB) Set-Aside, Request for Quote (RFQ). The solicitation utilizes source selection procedure using best value, which requires Quoters to submit a non-price proposal that includes past performance, experience information, and a price proposal for evaluation by the Government.

The resulting contract is planned to be a Firm-Fixed Price (FFP) Contract. The contract terms will be a base period for one year.

This procurement is to provide all labor, materials, and travel to perform bi-weekly on-site refurbishing of reusable medical equipment and if necessary, off-site repairs for instruments that require extensive repairs at the VA NJHCS East Orange VAMC.

Contractor will provide a qualified instrument RME repair technician.

The procurement consists of one solicitation with the intent to award a single contract to the responsible offeror whose proposal, conforming to the RFQ, will be most advantageous to the Government resulting in the best value, price and non-price factors, comparative analysis may be utilized for the source selection process.

Quoters are advised award may be made without discussions. Therefore, the Quoters should submit proposals which contain their best terms.

7. Set-Aside Status: The proposed contract is Total 100% Service-Disabled Veteran Owned Small Business (SDVOSB) set-aside. Prospective Quoters must be certified in SBA Veteran Small Business Certification (VetCert), Veteran Small Business Certification (sba.gov) in order to participate in this solicitation.

8. Additional Details:

THIS SOLICITATION WILL BE OFFERED IN ELECTRONIC FORMAT ONLY. NO HARD COPIES WILL BE PROVIDED. Quoters can view and/or download the RFQ and attachments at SAM.gov | Contract Opportunities when the RFQ is posted. Interested parties can register under the Interested Vendors List at sam.gov. This will be the only method of amendment distribution; therefore, it is the OFFERORS’ RESPONSIBILITY TO CHECK THE WEBSITE PERIODICALLY FOR ANY AMENDMENTS TO THE SOLICITATION.

9. Prospective Quoters MUST register themselves on the website. Prospective Quoters must also be registered with the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM in order to participate in this procurement.

Presolicitation Notice Presolicitation Notice

Presolicitation Notice

Background:

VHA Directive 1116(2)*, “Sterile Processing Service (SPS)” requires that SPS must have a systematic plan to assess and retire malfunctioning reusable medical equipment (RME) instrumentation by utilizing a company or intra-facility service that is certified to refurbish instrumentation. Currently there is no service located within the facility that has the knowledge and training to inspect, sharpen and perform all steps in the refurbishing process. The future goal is to acquire a service contract to be in compliance with the VHA Directive 1116(2). The goal and vision for the future is to receive recommendations for surgical instrument replacements, maintenance data, and quality assurance monitoring which will provide SPS with essential information to develop an annual budget for replacement instruments.

This service shall be provided by a qualified instrument RME repair technician provided by the Contracting service.

* See VHA Directive 1116_D_2023-07-17 - Updates the term reusable medical equipment (RME) to reusable medical devices (RMD) Objectives:

The purpose of this project is to obtain a contract with a company that provides on-site refurbishing of reusable medical equipment and if necessary, off-site repairs for instruments that require extensive repairs. By obtaining a service of this type, instruments will be inspected, repaired, sharpened, lubricated, and marked unrepairable during scheduled bi-weekly visits. In doing so, instrumentation used by EO VAMC providers will be maintained in good working condition to enhance positive patient outcomes during ambulatory and surgical procedures. Furthermore, the EO Sterile Processing Service will be able to be compliant with the VHA Directive 1116(2).

Scope of Work:

· The Contractor shall furnish all parts and labor to accomplish the tasks

· The Contractor shall Provide full-service repair for RME including electrical, re-insulation, sharpening, re-alignment

· The Contractor shall replace basic instrumentation that cannot be repaired

· The Contractor shall inspect, sharpen, and perform all steps in the refurbishing process - for all RME and containers.

· The Contractor shall work on-site with same-day service

· The Contractor shall coordinate specific dates for maintenance and repairs with the contracting officer or designee. In general, services will be scheduled bi-weekly, but dates for such services may vary depending on the type of procedures scheduled. Notification and confirmation for maintenance and repairs must be coordinated one week prior to the date requested. The services will be performed between the hours of 8:00am and 4:30pm for a period of 8 hours each occurrence.

· The Contractor’s technicians must be specifically trained in various types of surgical instrumentation including general surgery, GYN, ortho, neuro, eye, ENT, microsurgery, laparoscopic, cardiothoracic, vascular, and plastic surgery.

· The field service technicians shall work directly with the facility Sterile Processing Service and pull sets based on set usage and repair/refurbish accordingly, as well as servicing the repair bin containing instruments set aside during prep inspection that do not meet operating room standards for proper functioning.

· The Contractor shall test the functionality of the equipment upon completion of repair. If this is a test for repair, the test should ensure that damaged parts have been successfully repaired and all functions including, but not limited to those related to repaired parts, are operational. If this is a test for a routine PM service, inspection, etc., then the test should just ensure that the equipment is functioning within the guidelines of the OEM or the applicable standards (OSHA, ASSE, JCAHO, NEFP, etc.).

· Instruments will be retrieved by the Contractor and returned by the Contractor on the same day. If an instrument has extensive damage and cannot be repaired on-site, the contracting officer or designee must approve off-site repairs which may require a second level approval from a clinical manager or supervisor. If approved, the Contractor will provide within 3 business days a description of the defect, repair options, cost, and estimated time repair will be completed. Contracting officer or designee will determine whether to pursue off-site repair option or return instrument without repair. All instruments will be returned to EO VAMC via the warehouse. Under no circumstance will the Contractor retain VA property.

Deliverables for the service to provide to SPS:

· Roster of daily work including instruments needing replacement or unrepairable

· Instruments replaced

· Name of trays serviced on each visit Safety Requirements:

Contractor will adhere to all Federal, State and Local Requirements for conducting business on VA grounds. In performance of this contract, the technician will adhere to all safety standards set forth by the profession.

The Contracting repair services must be based on the same strict quality standards applied to the original manufacturer’s Instructions for Use (MIFU).

The Contracting Officer or his/her designee will notify the contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his/her representative at the site of the work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all and any part of the work and hold the Contractor in default.

Inspection:

Upon completion of the maintenance service, the SPS Chief or designee will perform the inspection in the presence of the contractor personnel, prior to the contractor personnel leaving the facility. This inspection will ensure that all equipment is returned to full functioning condition No invoices will be processed for payment prior to the completion of POC inspection.

All instruments will be returned to the NJHCS via the warehouse. Under no circumstance will the contractor retain VA property.

Government Furnished Property:

The Government will provide a space for the work to occur and electric hook up.

Other Related Services (Not Included in the Scope of Work):

Any services not expressly stated in this statement of work are not authorized. Services such as inspection, Original Equipment Manufacturer (OEM) required maintenance, or other maintenance and repair vital to the continued functioning of the systems may be added only after written modification from the contracting officer, unless they are inclusive to the requested services. No other person, including the COR or any other VA personnel are authorized to request additional work be performed by the contractor. Any additional services performed that are not authorized by the contracting officer will be considered inclusive.

The contractor will not have access to VA computer (IT) services or sensitive / personal health information (PHI) information.

Period of Performance:

One year contract from October 2023 – August 2024. Normal hours of services are Monday through Friday from 8:00 a.m. to 4:30 p.m., exc1uding the federal holidays. (Dates will be finalized upon award) Place of performance:

The contractor shall perform services on-site at the NJHCS East Orange Campus at 385 East Tremont Avenue East Orange, NJ 07018.

Contract type:

Firm Fixed Price. All repair services will be provided on a fixed, flat daily rate.

See attached document: wage determination 2015-4211.

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