R420--sterile processing ISO 9001:2015 certifying body services

This is a SOURCES SOUGHT NOTICE only. This is not a request for formal proposals or quotes. No formal solicitation document exists at this time. This request is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information.

PURPOSE AND OBJECTIVES:

The intent of this Sources Sought Notice is to identify potential vendors authorized to provide the Sterile Processing Services Departments within the VHA VISN 2 Medical Centers identified below certification to ISO 9001:2015 standards. Vendors must be a certification body (CB) with a valid Certificate of Accreditation to ISO 17021 that includes a scope of Public administration and Health and Social Work. The anticipated contract action is expected to be a firm fixed-price Contract with an anticipated period of performance of 02-01-2020 to 1-31-2025.

Task 1: Ongoing assessment of its Quality Management System (QMS) and its conformance with ISO 9001:2015.

The CB will conduct annual surveillance audits and a 9001:2015 recertification audit of Sterile Processing Services at seven VA Medical Centers and its Quality Management Organization (QMO) headquarters. The base year is anticipated to begin in February of 2021.

Period of Performance

SERVICE

Base Year

Surveillance Audit #1

Option Year 1

Surveillance Audit #2 with expansion of scope

Option Year 2

Recertification

option year 3

Surveillance Audit #1

Option year 4

Surveillance Audit #2

The CB shall provide all necessary labor, equipment, tools, materials and supervision to accomplish surveillance audits & recertification audits for the currently certified VISN QMO headquarters and the seven VAMCs sites (New Jersey, Hudson Valley Montrose & Castle Point, Northport, Bronx, Brooklyn and Manhattan). 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

SCOPE OF THE QMS AND ISO 9001:2015 CERTIFICATION:

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:

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:

New Jersey VA HCS/East Orange Campus

Building 1, Room 2-210

385 Tremont Ave

East Orange, NJ 07018

Northport VA Medical Center

Building 200, Room 1-23

79 Middleville Road

Northport, NY 11768

Hudson Valley HCS Castle Point

Building 16, Room 300 - 301

41 Castle Point Road

Wappinger Falls, NY 12590

Hudson Valley VA HCS

Building 7, Rooms 17i, 20

2094 Albany Post Road

Montrose, NY 10548

James J. Peters VA Medical Center

130 West Kingsbridge Road

Room GG01A

Bronx, NY 10468

New York Harbor VA HCS/Brooklyn Campus

800 Poly Place

Building 1,

Rooms B111, B115

Brooklyn, NY 11209

New York Harbor VA HCS/Manhattan Campus

423 East 23rd Street

Building 6,

Rooms G500-550

New York, NY 11010

TASK 2: Expand the current 9001:2015 QMS Scope to include four additional VISN2 VA Medical Centers. VISN 2 expects four additional locations to be in conformance with the 9001:2015 ISO standards and prepared for their initial certification at the time of recertification for the Task 1 sites, on or about December 15, 2022.

The additional four VAMC s scheduled to undergo the initial certification audit in December 2022 include:

.

VA Medical Centers:

Stratton VA Medical Center

Rooms D8; D9 A & B; D10; D11 A & B

113 Holland Ave

Albany, NY 12208

VA Western New York Healthcare System

Rooms 306C; 309C; 312C; 814A

3495 Bailey Avenue

Buffalo, NY 14215

VA Finger Lakes HCS Rochester Community-Based Outpatient Clinic

Rooms 5005; 5010; 5012; 5117

Calkins Road

Rochester, NY

Syracuse VA Medical Center

Rooms SG86; SG 87; SG 88-88A

800 Irving Avenue

Syracuse, NY 13210

As in TASK 1, the scope of the QMS in TASK 2 remains the same. 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.

RESPONSE:

Responses to this Sources Sought Notice should demonstrate the firm's experience in delivering the service listed above, as well as capability of performing these services in the areas listed above by including a copy of your ISO 17021 Certificate of Accreditation which shall include a scope of ISO 9001:2015 with specific IAF codes for public administration and healthcare.

Responses should include the following information: Business name, address, DUNS number, business size and Socioeconomic Category (HUBZone, 8(a), Service Disabled Veteran-Owned Small Business, Veteran-Owned Small Business, Small Business, Large Business, etc.), FSS Contract # if applicable, and point of contact to include e-mail address and telephone number. Offerors will be required to be registered in the System for Award Management (www.sam.com) prior to any future offer. Any interested capable parties shall submit their response by email prior to the response date. The NAICS Code is 541611, Administrative Management and General Management Consulting Services with a size standard of $16.5M.

All responses must be submitted via e-mail to Tevia.Mastykarz@va.gov