36C24125Q0227.docx

VACHS Critical Water Monitoring Program New 2025

GENERAL INFORMATION

SET-ASIDE

VAMC Manchester

718 Smyth Road Manchester NH 03104

POINT OF CONTACT*

Contract Specialist Nathan Langone Nathan.Langone@va.gov

PLACE OF PERFORMANCE

950 Campbell Ave

West Haven CT

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

This is a Sources Sought notice only. This is not a request for quotes and no contract will be awarded from this announcement. The Government will not provide any reimbursement for responses submitted in response to this Source Sought notice. Respondents will not be notified of the results of the evaluation.

If a solicitation is issued it shall be announced at a later date, and all interest parties must response to that solicitation announcement separately. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation The purpose of this announcement is to perform market research to gain knowledge of potential qualified sources and their size classification relative to NAICS 541380 (Testing Laboratories and Services) SBA size standard $19 Million. VA Connecticut is looking for their own Sterilization Processing Services for all RME and medical equipment processing. SPS is a critical part of any Hospital as it ensures all clinical departments have a readily available supply of sterile equipment. One of the key pieces of equipment supporting any SPS is the Critical Water support. Both West Haven and Newington have large Reverse Osmosis based water treatment systems that provide a direct critical water supply to SPS personnel and equipment. The full SOW is attached below for reference.

This Sources Sought notice provides an opportunity for respondents to submit their capability and availability to provide the requirement described below. Vendors are encouraged to submit information relative to their capabilities to fulfill this requirement, in the form of a statement that addresses the specific requirement identified in this Sources Sought. Information received from this Sources Sought shall be utilized to facilitate the Contracting Officer’s review of the market base, for acquisition planning, size determination, and procurement strategy.

Submission Instructions: Interested parties who consider themselves qualified to perform the services are invited to submit a response to this Sources Sought Notice by 17:00 EST, 06th of February 2025. All responses under this Sources Sought Notice must be emailed to Nathan.Langone@va.gov with Sources Sought # 36C24125Q0227 in the subject line. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Interested parties should complete the attached Sources Sought Worksheet. Parties may submit additional information related to their capabilities, provided it contains all the requirements contained in the Sources Sought Worksheet. Responses to this Sources Sought shall not exceed 8 pages. In addition, all submissions should be provided electronically in a Microsoft Word or Adobe PDF format.

Attachment 1 Sources Sought Worksheet

QUALIFICATION INFORMATION:

Company / Institute Name: _______________________________________________________ Address: ______________________________________________________________________ Phone Number: ________________________________________________________________ Point of Contact: _______________________________________________________________ E-mail Address: ________________________________________________________________ Unique Entity Identifier (UEI) #: ___________________________________________________ CAGE Code: __________________________________________________________________ SAM Registered: (Y / N) Other available contract vehicles applicable to this sources sought (GSA/FSS/NASA SEWP/ETC): __________________________________________________________________

SOCIO-ECONOMIC STATUS:

VIP Verified SDVOSB: (Y / N) VIP Verified VOSB: (Y / N) 8(a): (Y / N) HUBZone: (Y / N) Economically Disadvantaged Women-Owned Small Business: (Y / N) Women-Owned Small Business: (Y / N) Small Business: (Y / N) NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov.

BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SDVOSB, VOSB, SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION.

CAPABILITY STATEMENT:

Provide a brief capability and interest in providing the service as listed in Attachment 2 Statement of Work with enough information to determine if your company can meet the requirement. The capabilities statement for this Sources Sought is not a Request for Quotation, Request for Proposal, or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach, but rather the Government is requesting a short statement regarding the company’s ability to provide the services outlined in the SOW. Any commercial brochures or currently existing marketing material may also be submitted with the capabilities statement. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government. The Government will not pay for information solicited. Respondents will not be notified of the results of the evaluation.

Statement of Work VACHS Critical Water Monitoring Program

BACKGROUND

VACHS Critical Water Monitoring Program covers the main medical center at West Haven, CT and the Newington, CT Medical Center. Both CT facilities have their own Sterilization Processing Services for all RME and medical equipment processing. SPS is a critical part of any Hospital as it ensures all clinical departments have a readily available supply of sterile equipment. One of the key pieces of equipment supporting any SPS is the Critical Water support. Both West Haven and Newington have large Reverse Osmosis based water treatment systems that provide a direct critical water supply to SPS personnel and equipment.

The updated AAMI ST-108-2023 Standard, which governs the processes and requirements for Sterile Processing, added requirements to the roster of locations needing monthly critical water sampling. Per the standard, the requirement to test critical water at “every point of use” has significantly raised the quantity of water samples needed each month. Current water sampling contracts only cover the bare minimum of testing locations at the source of Critical Water systems.

At VACHS, we have been without any backup or extra testing on the annual contract. It is essential that an on-call or emergency testing balance be added to the new contract requirement. This will give VA leaders the ability to quickly re-test any areas that have been positive for contamination or allow leaders to check any area of concern. When an emergency re-test is needed, there is no time to source funding. The test and result are needed as fast as possible to restore operations in affected areas. A robust on-call/emergency testing balance is needed for this new contract. Furthermore, the contractor will have to guarantee a quick availability and turn-around time for these tests.

SCOPE OF WORK

The purpose of this Statement of Work is to provide all the details and requirements in developing a monthly Water Testing program for VACHS. There will be designated testing locations required for testing each month. There will also be general purpose testing locations that can be alternated as the SPS department’s needs.

The primary direction for this new contract requirement are detailed updates in the AAMI ST-108:2023 Standard, “WATER FOR THE PROCESSING OF MEDICAL DEVICES.” All contractor proposals should thoroughly review this standard.

The contractor’s responsibility of this contract includes, but is not limited to the following:

(1) Provide all labor, materials, tools, equipment, applicable state licenses and permits to accomplish this SOW.

(2) Provide all testing requirements as outlined by AAMI ST-108-2023 WATER FOR THE PROCESSING OF MEDICAL DEVICES. (SEE CHAP 11, TABLE 6) FOR testing quantity guides.

(3) Provide a fully qualified Laboratory for processing of water samples to meet all metrics from AAMI ST-108-2023. Ensure all laboratory certificates, credentials and capabilities are provided to VA FMS.

(4) Conduct Monthly Water Monitoring program for both Newington & West Haven

(5) Provide a sampling of the utility or supply water at each monthly testing date.

(6) Provide a rapid means of immediate shipping of all water samples to the approved laboratory.

(7) Provide a consolidated monthly report of all sample locations, results, parameters on a single report.

(8) Provide immediate notification of any positive samples over the bacteria and endotoxin threshold per AAMI ST 108.

(9) Provide an annual balance of Emergency / On-call tests for any locations that require re-testing or per direction of VA.

(10) Apart from the routine Critical Water Locations, VA may provide locations with any remaining balance of tests in areas such as: Dialysis, Pathology labs, Research Labs, and other areas on medical facility. There are myriad of smaller point of use De-ionization and Reverse Osmosis units throughout the facility that may need testing as required. VA FMS will direct as needed in advance of site visit.

UN-INTENTIONAL OR ACCIDENTAL CONTAMINATION OF THE CRITICAL WATER SAMPLES OCCURS WHEN THE TESTER DOES NOT MAINTAIN PROPER PPE, FLUSHING OF TEST PORT, CLEANING OF SITE, OR USE OF GLOVES. VA STAFF HAS RIGHT TO HAVE TESTER RE-TAKE A SAMPLE IF HE/SHE BELIEVES THE SAMPLE WAS TAKEN WITHOUT ADHERANCE TO RIGID PPE OR SAMPLING DISCIPLINE.

(11) Ensure contractor staff adhere to all PPE requirements when testing in PPE required areas.

(12) Ensure contractor staff conducts a thorough test-location wipe down with alcohol wipes and utilizes latex or vinyl gloves to avoid accidental contamination of sample.

(13) Ensure contractor staff conducts flushing of testing location valves, sample ports, sinks, sprayers…etc., to avoid accidental contamination.

(14) Enforce a strict chain of custody of sampling so that samples are secured and shipped by one dedicated technician.

(15) Contractor to immediately notify VA of any breach in chain of custody or shipping issues that would render the samples un-usable. Contractor to coordinate with VA on providing re-tests.

(16) All work to be done during normal operation hours. Any request for off hours work to be coordinated with COR or Mike Olechnicki VA Boiler Supervisor.

(17) The contractor shall verify all existing utility installations and take appropriate action prior to working in the vicinity of utility services (electrical, plumbing, HVAC, etc.).

(18) Contractor policies and procedures shall comply with VA Privacy and Security policy, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA).

(19) All contractor personnel shall obtain a short-term identification badge issued by the VA designee. Such badge shall be worn by the individual and prominently always displayed while on VA property. No employee of the contractor shall enter the project site without a valid identification badge issued by the VA. To obtain a short-term identification badge, contractor personnel shall present to the VA designee a valid (non-expired) photo identification issued by a US federal, State, or local government agency.

(20) The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

(21) The Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

(22) No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

(23) The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

(24) Please see below documentation and table from AAMI ST-108 on sampling requirements. The following table shows a baseline requirement for testing quantities with re-test quantities included as well. Contractor to review ST-108 Standard and table for best allocation of testing quantities.

Required Quantities of Critical Water Tests Monthly/Quarterly VA CONNECTICUT HEALTH CARE SYSTEM - AAMI ST-108-2023 CRITICAL WATER SAMPLING & TESTING TOTALS REQUIRED EACH OPTION YEAR / 12 MONTHS WEST HAVEN, CT & NEWINGTON, CT MEDICAL CENTERS

CRITICAL WATER AT POINT OF GENERATION

MONTHLY

CRITICAL WATER OTHER LOCATIONS - POINT OF USE

MONTHLY

UTILITY WATER AT POINT OF GENERATION

MONTHLY

UTILITY WATER AT SELECTED POINT OF USE LOCATIONS

QUARTERY

CRITICAL WATER RE-TEST BALANCE / ON CALL TESTING

PER OPTION YEAR

Any Outstanding Balance can be utilized as needed by VA

The Following Table from ST-108 highlighting key requirements (Please review full Standard ST-108 2023 for further information) Table 6—Frequency for water quality monitoring at point-of-water-use

Water quality measurement

Type of testing

Routine monitoring sampling site Minimum frequency of testing*

*NOTE 1 The recommendations for frequency of testing in this table are the recommended minimum frequency. If problems or issues arise with the water quality, it may be necessary to increase the frequency until they are resolved.

**NOTE 2 Test type needed to measure Critical Water and Steam levels. Steam condensate must be filled to the brim, sealed, and allowed to cool before testing to prevent carbon dioxide absorption.

The minimum frequency of testing aligns with established water monitoring programs performed during medical device manufacturing. Device processing is an extension of the medical device supply chain, so a continuation of the water quality requirements is necessary for continued patient safety. The testing frequency described in Table 5 and Table 6 are recommended minimum frequencies to demonstrate the water system remains in a state of control. The risk assessment performed by the multidisciplinary team may identify sampling points that will require an increase in testing frequency (e.g., less frequently used point-of-use, portion of circulation loop containing a dead-leg).

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