36C24221Q0300 0001.docx

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) 01-14-2021 528-21-1-3760-0006

NONE

Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga

NY

14227 Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga

NY

14227 To all Offerors/Bidders

36C24221Q0300 01-14-2021

X X X

The purpose to Amendment #A0001 is to provide answers to the following questions and to extend the RFQ until January 22, 2021. All responses will be due by January 22, 2021 by 10:00 AM EST. The answers to the questions are included herewith.

Joseph Cellino Contracting Officer

CONTINUATION PAGE

Solicitation # 36C24221Q0300 , Attachment A, Amendment A0001

1. What is the existing scope statement for the ISO 9001 Certification? (per SOW on pgs 2-4) The scope of the VISN2 Sterile Processing Service Quality Management System and ISO 9001:2015 certification encompasses the VISN2 ISO Administrative Program/QMO Headquarters and each of the following VISN2 VA Medical Center Sterile Processing Service specifically selected for conformity to the ISO 9001:2015 requirements. VISN2 VA Medical Center locations include:

Headquarters:

1. The NY/NJ VISN2 Office James J. Peters VA Medical Center Quality Management Organization 130 W. Kingsbridge Road, Building 16 Bronx, New York 10468

VA Medical Centers:

1. New Jersey VA HCS/East Orange Campus Building 1, Room 2-210 385 Tremont Ave East Orange, NJ 07018

1. Northport VA Medical Center Building 200, Room 1-23 79 Middleville Road Northport, NY 11768

1. Hudson Valley HCS Castle Point Building 16, Room 300 - 301 41 Castle Point Road Wappinger Falls, NY 12590

1. Hudson Valley VA HCS Building 7, Rooms 17i, 20 2094 Albany Post Road Montrose, NY 10548

1. James J. Peters VA Medical Center 130 West Kingsbridge Road Room GG01A Bronx, NY 10468

1. New York Harbor VA HCS/Brooklyn Campus 800 Poly Place Building 1, Rooms B111, B115 Brooklyn, NY 11209

1. New York Harbor VA HCS/Manhattan Campus 423 East 23rd Street Building 6, Rooms G500-550 New York, NY 11010

The Sterile Processing Services (SPS) Quality Management System (QMS) encompasses a network “headquarters” which manages the centralized, administrative SPS processes and local VAMC SPS locations which provide the primary processes of equipment intake, decontamination, preparation & assembly, sterilization/ high-level disinfection, storage, and out-take of critical and semi-critical reusable medical equipment (RME). The scope of the SPS QMS is specifically defined as everything within the direct control and authority of the VAMC Sterile Processing Services only. The QMS is executed within the walls of SPS and is bound by the walls of SPS.

VISN2 Quality Management System 2015 Clause Exclusion Table

7.1.5.1 General

7.1.5.2 Measurement traceability

8.2.4 Changes to requirements for products and services

7.1.5.1 General

7.1.5.2 Measurement traceability

2. When is the current ISO 9001: 2015 Certificate expiring? Provide current ISO 9001 Certification.

For facilities who have the certification, it expires in February 2023.

3. Will the additional sites to be added be under the existing HQ site certification (VISN) or be added as a separate certification for VAMC sites All sites will have separate certifications; each certification will include Veterans Integrated Service Network (VISN) 2 and the individual facility achieving ISO 9001:2015 certification.

4. What is the new scope statement for the additional VAMC sites or what is the proposed Same as response in #1.

5. Is the scope of ISO 9001 Certification for “administrative processes” only or does it include “specific sterile processing services”?

It includes both the headquarters , each of the affiliates. Sterile processing services occurs at the affiliates (VAMCs)

7. If it includes sterile processing services, then it may not be possible to take exclusions listed such as: 7.1.5, 8.5.1 - 8.5.5, etc.

We disagree with this statement and exclusions listed in response #1.

6. TECHNICAL

o Factor 1 Technical: 17025 is not applicable to conducting ISO 9001 Certification audits. This should be replaced by a Registrar that is Accredited to 17021. The scope of service is not 17025, therefore should be excluded.

Correction accepted, 17021.

7. PAST EXPERIENCE (per your guidance) o All lead auditors must be certified by the International Register of Certificated Auditors (IRCA). This should include equivalent as there are other certifications (e.g. Exemplar Global, and others, etc.)

No Change to this requirement, All lead auditors must be certified by the International Register of Certificated Auditors (IRCA). No substitutions.

8. Please clarify the requirement on page 4 of the PWS which states, “All sites will have separate certifications; each certification will include Veterans Integrated Service Network (VISN) 2 and the individual facility achieving ISO 9001:2015 certification.”

All sites will have separate certifications; each certification will include Veterans Integrated Service Network (VISN) 2 and the individual facility achieving ISO 9001:2015 certification.