36C25719Q1308-001.pdf

Attachment 2: Combined Synopsis/Solicitation for Commercial Items Template

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 1 of 5 Original Date: 10/12/17 Revision 01 Date: 01/08/18

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Document Type:

Solicitation Number:

Posted Date:

Original Response Date:

Product or Service Code:

Set Aside (SDVOSB/VOSB):

NAICS Code:

Combined Solicitation/Synopsis

36C25719Q1308

09 August 2019

15 August 2019

SMALL BUSINESS

339112

Contracting Office Address

Network Contracting Office 17, San Antonio, TX – Supply I

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-101 10-26- 2018. This solicitation is being requested as Brand Name or Equal IAW FAR 52.211-6.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1000 employees.

The STERILE PROCESSING SERVICE at the Olin E. Teague VA Medical Center is seeking to purchase Cataract trays.

All interested companies shall quotations for the following:

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 2 of 5 Original Date: 10/12/17 Revision 01 Date: 01/08/18

Schedule of Supplies

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

14.00 EA $0.00 $0.00

IN-2020-1955 custom surgical instrument sterilization tray Eye, Cataract, 41 INST., VA Temple.

LOCAL STOCK NUMBER: IN-2020-1955

Funding/Req. Number: 1 $0.00

GRAND

TOTAL

$0.00

Delivery shall be provided 30 days ARO FOB Destination. The contractor shall deliver line all line items to the following address:

Olin E. Teague VA Medical Center Attn: STERILE PROCESSING SERVICE 1901 Veteran Memorial Dr.

Temple, TX 76504-7451

Award shall be made to the offeror whose quotation is the lowest price technically acceptable.

The government will evaluate information based on the following evaluation criteria: price, delivery, and technical acceptability.

Price – This the total amount of the offeror’s quotation to include all items listed on the schedule of supplies and any charges for shipping/handling (starting Page 1 of this RFQ).

Delivery – This is the offeror’s ability to deliver the equipment within 30 days ARO.

Technical acceptability – This is the offeror’s ability to provide equipment in accordance with the following salient characteristics:

Statement of Salient Requirements

A. GENERAL INFORMATION

1. Title of Project: Cataract sterilization tray standardization

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 3 of 5 Original Date: 10/12/17 Revision 01 Date: 01/08/18

2. Scope of Work: Locate a cataract sterilization tray system that holds all items.

Central Texas Veterans Health Care System (CTVHCS) has been working with the eye surgery team to standardize and procure sterilization tray or system of trays that can safe guard micro eye surgery instruments, prevent potential damage to the eye instruments while reducing the number of surgical trays required for a procedure by bundling all necessary sterilized items into one sterilization tray system. The CTVHCS needs to expand its current inventory to allow for more eye procedures to be performed.

Standardization is part of the ISO program to make Sterile Processing more efficient, effective and reduce opportunity for errors.

The cataract surgery uses a microscope that requires silicone rubber knobs that are re-sterilized following a procedure. These knob covers are designed to slip over the sterile drape that covers the microscope to give the surgeon a good grip on the controls.

These knob covers are very light and often get flipped over and retain steam that turns to water during sterilization. Water in a tray equates to an unsterile tray and unsafe for patient care. These trays are designed to keep the knob covers from flipping and therefore not retaining water and having an unsterile “wet” (contaminated) tray.

Cataract surgery sets use 41 instruments that are specific to the CTVHCS eye surgery team. Cataract sets use many micro instruments and are very small and are often easily damaged due to their small size. They can often be secured in special holders but the securing system also needs to allow for easy release for staff to retrieve during the surgical procedure.

Market research was performed prior to securing current tray system in use. The following questions were key to determine the best tray that met the facility needs.

a. Does tray work well with existing Aesculap sterilization containers and blue wrap?

b. Does tray work well with staff that will be using tray in Surgery?

c. Does tray work well for staff re-processing and sterilizing instruments in tray?

d. Is the tray compatible with the following sterilization formats; Gravity and PreVacuum Steam sterilization, V-Pro , V-Pro Max and Sterrad NX, Sterrad NX100 Low temp sterilization processes. Must be cross compatible with both systems.

Required:

A. FDA cleared for steam sterilization using rigid Aesculap steam sterilization containers, Aesculap filters and sterilization container locks.or blue single use steam sterilization wrap.

B. Sterilization tray that protects 41 delicate micro surgical and ophthalmic eye surgery instruments with design that facilitates sterilization, Sized 15 1/4” x 9 5/8” x 4 ¾”. Must have retractable handles to allow for tray to be removed from sterilization container without compromising

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 4 of 5 Original Date: 10/12/17 Revision 01 Date: 01/08/18 space for instruments or possible contamination by sterile gloves contacting the outer tray.

Must fit the Aesculap container JK742. Must be compatible with the CTVHCS SPS protocols, current Aesculap sterilization filters, sterilization tray locks and container storage systems.

Must secure the instruments without making difficult loading or unloading of the storage points, thus preventing bending and torqueing the micro instruments.

Must safely secure Phaco or Vitrectomy handpiece to include cord and have a small secure covered container for tips physically attached to tray.

Tray must have small rounded feet underneath to prevent damage to sterile field drapes and elevate tray to allow complete steam penetration of items to be sterilized and facilitate water drainage during re-processing and prevent condensation after steam sterilization.

Tray must allow modular expansion and adjustment of instrument storage points with the use of minimal tools yet secured. Instrument store points should not be removable or adjustable without tool to prevent accidental movement during use.

Tray must use silicone holders and instrument pads and retain micro eye instruments safely in position in ANY position of tray, even upside down.

Tray must be able to be processed using both pre-vacuum and gravity steam sterilization and low temp plasma sterilization using the Sterrad NX, Sterrad NX100 and the V-Pro and V-Pro Max. Cross compatibility is a requirement.

CTVHCS Eye surgery team has a unique Cataract eye tray system that is customized to their procedure process and work flow. Tray needs to be specific to the instrument sets and has specific locations for each micro instrument, knob and surgical hand piece.

Trays being evaluated must work with existing sterilizations systems and processes established at CTVHCS; Steris Steam sterilizers and washers, Aesculap sterilization containers, filters and sterilization container locks for primary steam sterilization process and Halyard blue wrap as an alternative steam sterilization process.

Tray design should minimize water entrapment points and allow for steam sterilization integrators to be placed in multiple points on the multiple levels of the sterilization tray to confirm sterilization occurred.

Cataract instrument trays need to be rigid and sturdily constructed to endure multiple re-processing of instruments yet light weight.

C. Tray must prevent rubber microscope knob covers from flipping and capturing moisture/water.

D. Must have a built-in covered location (box) built in or attached to tray.

E. Tray must be latex free. Latex free silicone instrument holders that allow for reconfiguration. Latex free rubber feet and corner guards

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 5 of 5 Original Date: 10/12/17 Revision 01 Date: 01/08/18

F. Easy to open latches that facilitate access to instruments without risk of damage to sterile gloves and contamination of instruments.

G. Trays must be able to be steam sterilized, plasma Sterilized mechanically washed and thermo-disinfected.

ADDITIONAL DESCRIPTION OF PRODUCT NEEDED:

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items”

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items”

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

• FAR 52.212-4, “Contract Terms and Conditions–Commercial Items”

• FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive

All questions related to this acquisition shall be submitted via email to jesus.casiano@va.gov.

All questions are to be received no later than 3:00PM CST 12 August 2019.

Quotes shall be submitted via email to jesus.casiano@va.gov. All quotes and additional required documentation are to be received no later than 2:00PM CST 15 August 2019.

For information regarding this solicitation please contact:

Jesus Casiano Contract Specialist

(210) 694-6243 jesus.casiano@va.gov http://acquisition.gov/comp/far/index.html https://www.sam.gov/portal mailto:jesus.casiano@va.gov mailto:jesus.casiano@va.gov mailto:jesus.casiano@va.gov