Combined Synopsis-Solicitation for Commercial Products and Commercial Services Revision 01 Effective: 05/30/2023 Description This is a combined synopsis/solicitation for commercial products and services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as RFQ 36C24125Q0227. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-03. The associated North American Industrial Classification System (NAICS) code for this procurement is NAICS 541380 (Testing Laboratories and Services) SBA size standard $19 Million. This is being bid as a VOSB set-aside. This is a solicitation for VA Connecticut Healthcare System requires 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 duration of the contract will be a base plus 4 OY. Any technical questions will be directed at Cornelius Finnegan IV (203) 932-5711 x3817. All interested companies shall provide quotations for the following: 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: Provide all labor, materials, tools, equipment, applicable state licenses and permits to accomplish this SOW. 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. 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. Conduct Monthly Water Monitoring program for both Newington & West Haven Provide a sampling of the utility or supply water at each monthly testing date. Provide a rapid means of immediate shipping of all water samples to the approved laboratory. Provide a consolidated monthly report of all sample locations, results, parameters on a single report. Provide immediate notification of any positive samples over the bacteria and endotoxin threshold per AAMI ST 108. Provide an annual balance of Emergency / On-call tests for any locations that require re-testing or per direction of VA. 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. Ensure contractor staff adhere to all PPE requirements when testing in PPE required areas. 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. Ensure contractor staff conducts flushing of testing location valves, sample ports, sinks, sprayers etc., to avoid accidental contamination. Enforce a strict chain of custody of sampling so that samples are secured and shipped by one dedicated technician. 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. 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. 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.). Contractor policies and procedures shall comply with VA Privacy and Security policy, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). 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. 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. 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.]. 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. 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. 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 TEST TYPE Qty per Year FREQUENCY    CRITICAL WATER AT POINT OF GENERATION  BACTERIA (HPC) HETEROTROPHIC PLATE COUNT 84 MONTHLY ENDOTOXIN (LAL) 84 MONTHLY PH 84 MONTHLY TOTAL ORGANIC CARBON 84 MONTHLY CONDUCTIVITY 84 MONTHLY ALKALINITY 84 MONTHLY          CRITICAL WATER OTHER LOCATIONS - POINT OF USE     BACTERIA (HPC) HETEROTROPHIC PLATE COUNT 96 MONTHLY ENDOTOXIN (LAL) 96 MONTHLY       UTILITY WATER AT POINT OF GENERATION   24 MONTHLY    UTILITY WATER AT SELECTED POINT OF USE LOCATIONS   12 QUARTERY          CRITICAL WATER RE-TEST BALANCE / ON CALL TESTING     BACTERIA (HPC) HETEROTROPHIC PLATE COUNT 12 PER OPTION YEAR ENDOTOXIN 12        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* Utility Water Critical Water Steam pH pH meter** or Colorimetric dipsticks (sample tested within 15 minutes) At the point the distribution loop enters the processing area or first POU on the distribution loop Quarterly Monthly Quarterly Conductivity Conductivity meter** or Colorimetric dipsticks At the point the distribution loop enters the processing area or first POU on the distribution loop Quarterly Monthly Quarterly Total Alkalinity Colorimetric dipsticks or Alkalinity test kit** At the point the distribution loop enters the processing area or first POU on the distribution loop Quarterly Monthly Quarterly Total hardness Determination of ppm as CaCO3 by Colorimetric dipsticks, Titration kit** ,or Handheld meter** At the point the distribution loop enters the processing area or first POU on the distribution loop Quarterly Monthly Quarterly Bacteria Heterotrophic plate count (see Annex H) Each location of point-of- use in department Quarterly Monthly N/A Endotoxin LAL test (see Annex H) Each location of point-of- use in department N/A Monthly N/A Visual Inspection Visual Inspection of inside of equipment - Look for residue, staining, scaling, and discoloration (Annex I) Spray Arms/Inside Chamber Walls/Inside Interior of Machine Daily Daily Daily *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). Evaluation Process Award shall be made to the best value, as determined to be the most beneficial to the Government. Please read each section below carefully for the submittals and information required as part of the evaluation. Failure to provide the requested information below shall be considered non-compliant and your quote could be removed from the evaluation process. Offeror quotes shall be evaluated under FAR Part 13.106-2(b) -- Evaluation of Quotations or Offers. Therefore, the Government is not obligated to determine a competitive range, conduct discussions with all contractors, solicit final revised quotes, and use other techniques associated with FAR Part 15. The contracting techniques associated with FAR Part 15 are not mandatory. The Government shall award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation shall be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Price (Follow these instructions): Offeror shall complete the attached Price Schedule, with offerors proposed contract line-item prices inserted in appropriate spaces. Ensure your representations and certifications are complete in the System for Award Management (SAM)( https://www.sam.gov). Otherwise, you will need to fill out solicitation Clause 52.212-3 "Offeror Representation and Certifications -Commercial Items and submit with the quote. Federal Acquisition Regulations require that federal contractors register in the SAM database at http://www.sam.gov and enter all mandatory information into the system. Award cannot be made until the contractor has registered. Offerors are encouraged to ensure that they are registered in SAM prior to submitting their quotation. Past Performance: Provide (3) references of work, similar in scope and size with the requirement detailed in the Statement of Work. References must include contact information; brief description of the work completed, and contract # (if relevant). Please utilize Attachment 1 Past Performance Worksheet for your references and please submit as part of your quote submission. References may be checked by the Contracting Officer to ensure your company can perform the Statement of Work. The Government also reserves the right to obtain information for use in the evaluation of past performance from all sources. Technical: The offeror s quote shall be evaluated to determine if the organization has the experience and capabilities to provide the requested services IAW the Statement of Work in a timely efficient manner. Contractor shall demonstrate their corporate experience and approach to meet all requirements stated in the Statement of Work. Contractor shall demonstrate that their technicians meet the qualification standards stated in the Statement of Work. Contractor shall provide all current and relevant or license(s) to include manufacture training certificate etc. If you are planning to sub-contract some or all of this work, please provide the name and address(s) of all subcontractor(s) (if applicable) and a description of their planned subcontracting effort. 4. Veterans Preference Factor (per 852.215-70): The Government will assign evaluation credit for an Offeror (prime contractor) which is a Service-Disabled Veteran-Owned (SDVOSB) or a Veteran-Owned Small Business (VOSB). Non-SDVOSB/VOSB Offerors proposing to use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation Factor. a. For SDVOSBS/VOSBs: In order to receive credit under this Factor, an Offeror shall submit a statement of compliance that it qualifies as a SDVOSB or VOSB in accordance with VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors . Offerors are cautioned that they must be registered and verified in Vendor Information Pages (VIP) database (http://www.VetBiz.gov). Verified SDVOSBs will receive a 5% price credit (e.g. if a SDVOSB submits an offer of $100.00, it will be evaluated as if it submitted an offer of $95.00). ii. Verified VOSBs will received a 2.5% price credit (e.g. if a VOSB submits an offer of $100.00, it will be evaluated as if it submitted an offer of $97.50). The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. (x) Please include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with your offer via the SAM.gov website or a written copy. (xi) Clause 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition in addition to the following addenda s to the clause: 52.252-2 Clauses Incorporated by Reference (FEB 1998), 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (JUN 2020), 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011), 52.204-13 System for Award Management Maintenance (OCT 2018), 52.204-18 Commercial Government Entity Code Maintenance (AUG 2020), 52.217-9 Option to Extend the Term of the Contract (MAR 2000), 52.228-5 Insurance-Work on a Government Installation (JAN 1997), 52.232-40 Providing Accelerated Payments to Small Business Subcontracting (DEC 2013), 852.212-70 Provisions and Clauses Applicable to VA Acquisitions of Commercial Items (APR 2020) 852.203-70 Commercial Advertising 852.219-74, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside 852.232-72 Electronic Submissions of Payment Requests 852.233-70 Protest Content/Alternative Dispute Resolution 852.233-71 Alternate Protest Procedure 852.270-1 Representatives of Contracting Officers 852.219-74 Limitations on Subcontracting Monitoring and Compliance (JUL 2018) As prescribed in 819.7203(a) insert the following clause: (a) This solicitation includes 852.219-74, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside, (b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor s compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor s offices where the Contractor s business records or other proprietary data are retained and to review such business records regarding the Contractor s compliance with this requirement. (c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor s business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. (d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor s compliance with the limitations on subcontracting or percentage of work performance requirement. (End of clause) 852.219-77 VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction. As prescribed in 819.7009(c) insert the following clause: VA NOTICE OF LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (SEP 2021) (DEVIATION) (a) Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that (1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Contracting Officer check the appropriate box below based on the predominant NAICS code assigned to the instant acquisition as set forth in FAR 19.102.] (i) [X] Services. In the case of a contract for services (except construction), the contractor will not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-74 or VOSBs as set forth in 852.219-11. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Other direct costs may be excluded to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service as set forth in 13 CFR 125.6. (ii) [ ] General construction. In the case of a contract for general construction, the contractor will not pay more than 85% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-74 or VOSBs as set forth in 852.219-11. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 85% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted. (iii) Special trade construction contractors. In the case of a contract for special trade contractors, the contractor will not pay more than 75% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-74 or VOSBs as set forth in 852.219-11. Any work that a similarly situated subcontractor further subcontracts will count towards the 75% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted. (2) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution. (3) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following: (i) Referral to the VA Suspension and Debarment Committee; (ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and (iii) Prosecution for violating section 1001 of title 18. (b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract. The Contracting Officer may, at their discretion, require the Contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the Contracting Officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed. (c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance with the limitations on subcontracting requirement. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate. (d) Offeror completed certification/fill-in required. The formal certification must be completed, signed, and returned with the offeror s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award. I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror]. Printed Name of Signee: _________________________________ Printed Title of Signee: ________________________________ Signature: ______________________________________________ Date: ___________________________________________________ Company Name and Address: _____________________________________________________________________________________ (End of clause) 852.242-71 Administrative Contracting Officer. As prescribed in 842.271, insert the following clause: ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation shall be furnished to the Contractor. (End of clause) (xii) Clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and in addition to the following FAR clauses cited, which are also applicable to the acquisition: 52.203-6, 52.204-10, 52.209-6, 52.219-4, 52.219-8, 52.219-6, 52.219-28, 52.222-3, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-3, 52.225-13, 52.232-33, 52.222-41 (Wage Determination West Haven and Newington VAMC WD 2015-4127 and 2015-4119 (Rev-28), 52.222-42, 52.222-43, 52.222-55, 52.222-6 (xiii) All contract requirement(s) and/or terms and conditions are stated above. (xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this requirement. (xv) RFQ questions are due NLT 02/19/2025 at 17:00 PM EST. RFQ responses are due NLT 02/21/2025 at 17:00 PM EST. RFQ responses must be submitted via email with RFQ #36C24125Q0227 in the subject line to: Nathan.Langone@va.gov Hand deliveries shall not be accepted. (xvi) The POC of this solicitation is Nathan Langone (Nathan.Langone@va.gov)
