36C25624Q1047 0001.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 3 n/a

Department of Veterans Affairs Veterans Health Administration Network Contracting Office 16 2575 Keystone Crossing Fayetteville AR 72703

Department of Veterans Affairs Veterans Healthcare System of the Ozarks Network Contracting Office 16 2575 Keystone Crossing Fayetteville AR 72703

To all Offerors/Bidders

36C25624Q1047

X x x

The purpose of this amendment is to answer questions about the solicitation.

There is no extension to the offer due date or time.

Q 1. Regarding RFQ 36C25624Q1047, is this a brand name only requirement?

Answer: Products submitted on quote should be Brand Name Aseculap or equivalent meeting the following salient characteristics:

Sterile Container System

Salient Characteristics:

• FDA-cleared containers for use in sterilization methods including PreVac Terminal, PreVac IUSS, Gravity Steam, EtO, and STERRAD, STERIS, and STERIZONE low-temperature

• Ergonomic container handles stop at 90 degrees

• Single-step latch system

• Single-motion filter retention plate with audible click

• Lifting points on each end of containers allow SPD staff to close and OR staff to open aseptically

• Containers are validated to be stacked during sterilization and storage

• Rigid containers are accompanied by an IFU adhering to and compliant with current processes and sterilization equipment utilized within the SPS Department of the Michael E DeBakey VA Medical Center

• FDA-cleared Steam sterilization dry time of 15 Minutes while still allowing for items to be stored for later use

• FDA clearance to maintain sterility of contents for up to 360 days for PreVac Terminal, PreVac IUSS, Gravity Steam, EtO, and STERRAD, STERIS, and STERIZONE low-temperature sterilization methods

• Item numbers for each container product allowing users to order lids, bottoms, baskets individually

• OEM-owned mobile repair service validated to repair the containers

• Rigid containers are accompanied by a lifetime warranty on manufacturing defects and minimum 3-year warranty on gaskets

• A comprehensive Instrument Organization System (IOS) is available including baskets, instrument brackets, and mats for care and handling

• Shelf life of 10+ years when properly maintained

Aicon Sterile Container System

Salient Characteristics:

• Single-motion latch closure system with large lifting handle

• Tamper-evident lock visible from the front and top of container

• Lock lays flat to protect it during transportation and handling

• QR code on container provides product info and Instructions for Use (IFU)

• Interchangeable color faceplates and tags

• Retaining brackets secure additional information

• Ergonomic integrated handle evenly distributes weight

• Optional cover adds protection when transporting between facilities and may remain in place during cleaning and sterilization

• Full-sized container only requires one filter per set

• Filter retention plate holds filter in place and protects filter from damage and strike through

• Non-slip wavelike basket bottom holds instruments in place

• Vertical mesh in basket sidewalls improve draining

• Optional basket lid for additional protection of set contents

• Large ergonomic basket handles

• Smooth and rounded design allows basket to be used with containers or single-use wrap

• Identical tags can be used on basket and removable container faceplate for synchronization

• Baskets nest together securely, with or without basket lid, allowing stacking in containers during storage

• Container sizes ranging from 11-7/8” L x 11-3/4” W x 4” H to 23-5/8” L x 11-3/4” W x 10”

H

• Basket sizes ranging from 9-3/8” L x 9-7/8” W x 1-3/8” H to 23-5/8” L x 9-7/8” W x 4-

1/8” H

• Single lid fits all container depths at full, ¾, and ½ sizes

• Faceplates available in (10) different colors

• Tags available in (9) different colors, sizes Large and Small

• Container locks available in multiple colors, with and without steam indicator

• Demonstrated pre- and post-sterilization weight difference of less than 0.2% in accordance with ANSI / AAMI ST77

Nothing else follows.