36C25626Q0128.docx

STATEMENT OF WORK (SOW)

GENERAL INFORMATION

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist Rhonda Gibson rhonda.gibson2@va.gov 3192198990

PLACE OF PERFORMANCE

2495 Shreveport Hwy

Pineville LA

ADDITIONAL INFORMATION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

1. Title: Sterile Processing Service (SPS)Water Testing

2. Purpose: The Network Contracting Office (NCO) 16 located at 5075 Westheimer Road, Galleria Financial Center, Suite 750, Houston, Texas, hereby issues the following Sources Sought to Request Information (RFI) with the intent of determining the contractor interest, capabilities, qualifications of potential businesses, nonmanufacturer rule compliance, Buy American Act compliance, Trade Agreement compliance and estimated industry pricing information for market research and estimated budgetary purpose for Sterile Processing Service (SPS)Water Testing.

Contractor shall provide all shipping, installation (if required), equipment, personnel, labor and testing for name brand. This Sources Sought is published for market research purposes. This Sources Sought will be used to determine if a set-aside for any small business program is appropriate. Government anticipates competitive, firm fixed price contract. Please review this announcement, respond to questions below and review all attachments in their entirety.

Government requests that interested offerors complete all questions below, provide required documentation, descriptive literature and authorization letter as described below. The Government is in no way obligated to do business with or to enter into any form of contract with any person, firm or other entity that receives or responds to this announcement.

Responses Requested: The MEDVAMC requires all the following information and questions answered in this RFI/SS: Questions and information that is not provided shall be considered nonresponsive to the Request for Information and contractor shall not be considered as part of the market research. Please answer all questions.

a. Contractors shall provide their point(s) of contact name, address, telephone number, and email address, and the company's business size, and SAM Unique Entity Identification Number. b. Is your company a small business, SDBs, HUBZone, or 8A concern? Please provide proof of qualifications.

b. Does your company meet all required four prong factors for the Nonmanufacturer Rule (NMR) per guidance of SBA and 13 C.F.R. § 121.406 Offer must answer all questions below.

1. Does your company exceed the 1250 employee alternative size standard for nonmanufacturers? ___

2. Is your company primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied? __________

3. Does your company must take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice? __________

4. Does your company supply the end products of a small business manufacturer or processor made in the United States? _____________

c. Is your company considered small under the NAICS Code 541380

d. Do you (offer) manufacture the product yourself or a distributor of the items being researched above?____

e. Are you an authorized distributor/reseller? Provide evidence from original equipment manufacturer (OEM).

f. Do you (offer) supply a product manufactured by another domestic small business, if it is a nonmanufacturer?

g. Do you (offer) supply the product of any sized manufacturer if SBA has granted a waiver to the nonmanufacturer rule?

h. Is your (offer) Buy American Certificate completed in SAM? Please provide evidence with response.

i. Is your (offer) Trade Agreement Certificate completed in SAM? Please provide evidence with response.

j. What is your schedule of delivery after receipt of order for the name brand or equal product?

k. For the name brand or equal product required, Is your company available under any;

Government Wide Agency Contract (GWAC) General Services Administration Schedules (GSA) Indefinite Delivery Indefinite Quantity (IDIQ) Blanket Purchase Agreement (BPA) If so, please list the contract number for name brand or equal product.

l. Provide descriptive literature demonstrating ability to meet all of the requirement/salient characteristics listed if other than brand name product is being offered. Please provide list of contracts for commercial, federal, state, and local governments. Listed contracts shall provide communication on the government requirement illustrating the capability for comparison. to the name brand or equal product meeting the specific requirements per the draft Statement of Work.

m. Contractors shall provide an estimated industry pricing for name brand product for market research and budgetary purposes.

5. Opportunity: NCO 16 is seeking information from potential contractors on their ability to provide this service. THIS IS A SOURCES SOUGHT FOR REQUEST INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this Sources Sought in order to assist the MEDVAMC in determining potential levels of competition available in the industry. The Contractor shall possess the capability to provide all requirements and objectives.

6. Instructions and Response Guidelines: Sources Sought responses are due by Nov 7, 2025, at 10:00 am (CST) via email to rhonda.gibson2@va.gov.

All Questions shall be submitted by Nov 4, 2025, at 10:00 pm (CST) via email to Rhonda.gibson2@va.gov.

Telephone requests or inquiries will not be accepted.

Public Information will not be provided and shall be utilized to the full extent possible.

This is a New Requirement.

The subject line shall read: 36C25626Q0128-RFI-Sources Sought- Sterile Processing Service (SPS)Water Testing– Alexandria VAHCS, Pineville, LA 71360. NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 5(a) - 5(o).

Please provide the information you deem relevant in order to respond to the specific inquiries of the Sources Sought. Information provided will be used solely by MEDVAMC as "market research" and will not be released outside of the MEDVAMC Purchasing and Contract Team.

This Sources Sought notice does not constitute a Request for Proposal (RFP), Invitation for Bid (IFB), or Request for Quotation (RFQ), and it is not to be construed as a commitment by the Government to enter into a contract, nor will the Government pay for the information submitted in response to this request. All information contained in this Sources Sought is preliminary as well as subject to modification and is in no way binding on the Government.

In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. If a solicitation is released, it will be synopsized on Contracting Opportunities (https://beta.sam.gov/) website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this Sources Sought, or future RFP/RFQ.

7. Contact Information:

Contract Specialist, Rhonda Gibson Email address: Rhonda.gibson2@va.gov Your responses to this notice are appreciated.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS; however, any firm that believes it can meet the requirements may provide answers, responses and give written notification prior to the response due date and time. Supporting evidence and responses must be furnished in enough detail to demonstrate the ability to perform the requirements.

***** End Word Document ******

See attached document: Draft 02 _SOW Sterile Processing Service (SPS)Water Testing

Sources Sought Notice Sources Sought Notice

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Sources Sought Notice

1. Contracting Officer Representative

Pineville LA, 71360

2. Contract Title: SPS Water Testing

1. Background: The Alexandria VA Health Care System (AVAHCS) is required to conduct Sterile Processing Service (SPS) sampling per The Association for the Advancement of Medical Instrumental (AAMI ST108). Additionally, the medical center is required to complete testing on all water and steam systems utilized in the reprocessing of reusable medical devices. Water impurities can have adverse effects on medical devices and patient outcomes. The requirements of AAMI ST108 are intended to mitigate the risks associated with water identified to be in improper quality. VA requires monthly, quarterly, and annual source water samples for this requirement. The service shall be performed by a certified Environmental Protection Agency or a State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic).

Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government. The Contractor shall have the technology and knowhow to efficiently and effectively manage services in its entirety. The Contractor shall have the capability to support testing quantity increases for unforeseen and/or unscheduled conditions.

2.Scope: The Contractor shall provide all resources necessary to accomplish the deliverables described in this Statement of Work (SOW), except as otherwise be specified. Furnish all labor, tools, materials, equipment, and supervision necessary to perform all work associated with sampling and testing for certain water quality criteria in the Reverse Osmosis (RO) System for Sterile Processing & Storage Service (SPS) and HVAC Condenser System Loop. Water sampling locations are at the Alexandria VA Health Care System (AVAHCS) located at 2495 Shreveport HWY, Pineville, LA 71360.

3.Objective: The Alexandria VA Health Care System (AVAHCS) Sterile Processing Service (SPS) is establishing a contracted water quality testing program on a monthly testing cycle in accordance with AAMI ST108:2023 and requirements for Steris equipment operation Instructions for Use (IFU).

The purpose of this contract is to procure Laboratory Analysis of water samples for AAMI compliance with water quality in accordance with VHA Directive 1116(2) dated September 09, 2024. Reference guidance in current AAMI ST:108 and various equipment IFU and Steris equipment IFU.

The Contractor shall provide for the use of secure password protected web-based reporting with history of reports maintained on vendor database and exportable as excel and pdf documents.

AVAHCS intends to make this water testing for two physical locations and to make requirement “turn Key” To The Fullest Extent Possible.

4.Requirements:

1. Water testing will be conducted monthly. The vendor shall come to AVAHCS location to take water samples in secured areas of the AVAHCS SPS areas. Utility and Critical water will be tested. Reports will be supplied electronically and hard copy.

a. Alexandria VA Medical Center, 2495 Shreveport Hwy, 71 North, Pineville, LA 71360

2. AVAHCS-SPS requires water testing to occur in AM (morning) of day to ensure water testing does not interfere with SPS workflow or risk of workflow causing contaminated sample. Water samples should be performed using same criteria as AAMI ST108.

3. Sampling locations for SPS Water as listed in below chart.

4. The total samples needed is described in Attachment A.

5. Schedule Of Supplies:

a. The Contractor shall supply all sampling supplies, containers, and shipping labels. The Contractor shall supply training as needed for emergency samples to be collected and shipped. Contractor shall pay for postage and shipping on any samples requiring re-testing.

b. AAMI compliance with water quality Water Testing Requirements.

c. General Procedures for AAMI compliance with water quality.

i. The Contractor shall furnish all sample collection bottles and return shipping labels, all transportation costs, and resources necessary to perform for AAMI compliance with water quality testing. The Containers shall be sterile, appropriate for the analysis, properly preserved, and ready for prompt transportation to the laboratory under strict chain of custody procedures. The Contractor shall provide trained staff to perform sample collections.

ii. VA requires monthly, quarterly, and annual source water samples for analysis plus 28 emergency samples if necessary.

The Contractor is responsible for the following:

a. Testing

6. Sample/specimen Analysis and Reporting:

a. The testing laboratory processing the water samples for AAMI compliance with water quality shall be proficient at performing water quality AAMI compliance cultures from environmental samples.

i. The full 250 ml volume of potable water (utility) shall be concentrated for routine quarterly testing. The testing laboratory shall retain samples that test positive for AAMI compliance with water quality for 30 calendar days and shall release them to the healthcare system if requested.

ii. Endotoxin testing shall be in compliance with use of Limulus Amoebocyte Lysate testing as listed in AAMI ST108.

b. The laboratory shall have environmental microbiology accreditation by a nationally recognized accrediting body, such as EMLAP, NELAP, etc. Proof of certification shall be provided before acceptance of contract.

c. The Contractor shall provide all sample analysis reports via e-mail to identify COR and Alexandria VA Health Care System Point of Contacts.

d. The Contractor shall provide water testing services no less than once per month and more frequent if necessary. Successive stops between testing shall not exceed 35 calendar days.

e. The Contractor shall notified if of any positive sampling results and notification will be made within 24 hours or 1 working day of making this determination. Confirmation of notification from AVAHCS required complete notification process.

f. The Contractor Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations and conditions, including the specific outlet temperature of water at the time the sample was collected, pH, biocide residual levels, method detection limits, and a description of test methodology. Sample reports need to be provided in a format that can be copied into the AVAHCS SPS AAMI water quality sampling results reporting form. Sample analysis reports shall be provided within 7 calendar days of the lab receiving the samples. If the 7th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day.

g. The Contractor shall have qualified technical support staff for consultation relative to proper water sample collection, testing, and interpretation of results.

h. The collection of samples shall be performed in full compliance with facility PPE practice and policy.

i. The unscheduled event related collections may be required to be collected on weekends and federal holidays.

j. The assistance with interpretation of reports and creating effective plan of action consultation required.

7. The Contractor shall provide water testing equipment: The Contractor shall provide submittals of water testing equipment or lab certification that they intend on using to carry out the requirements of this contract. Submittals will then be evaluated to ensure that equipment is appropriate and certified.

i. Requirements and Procedures for Sampling of SPS water lines for CFU and Endotoxin:

The contractor shall utilize testing procedures per AAMI ST108. Proof of certification and outline of actual testing procedures shall be provided before acceptance of the contract.

ii. Bacteria in water readings of less than 1CFU may be recorded as 500 cfu/ml.

iii. Requirement -Utility water with bacteria in water findings of 500 cfu/ml.

iv. All readings greater than 1CFU/ML should be quantified in whole numbers or greater than 500 may be recorded as 500 cfu/ml.

vi. The sampling shall be tested for presence of Endotoxin and response of results expected in less than 24 hours. Testing should be conducted and resulted in less than 7 days. Parameters for LAL testing as listed in AAMI ST108.

1. Weekend and Holidays are included in the timed suspense as the AVAHCS is in continuous operation.

b. The Contractor shall provide all sample analysis reports via e-mail to the COR and the assigned Points of Contact within the AVAHCS -SPS service within 7 calendar days including weekends and holidays of receiving the sample. If the 7th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, method detection limits, and a description of test methodology.

c. The Contractor shall have qualified technical support staff for consultation relative to water sample collection, testing, and interpretation of results.

d. The Contractor shall provide expertise to formulate effective plans of action to correct the water to a safe condition, within parameters established.

e. The Contractor shall take all responsibility of their staff while on AVAHCS property. All the Contractor staff will be required to wear full PPE supplied by the AVAHCS SPS, no exceptions. The Contractor’s field service employee will wear visible identification issued by the VA Police Service.

f. The Certification & Accreditation requirements do not apply, and a Security Accreditation Package is not required.

8. Certifications: The Contractor shall be certified by the Environmental Protection Agency or a State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic).

9. Special Qualifications:

The Contractor shall, without additional expense to the Government, be responsible for obtaining any necessary licenses and permits, and for complying with any applicable Federal, State, and Municipal laws, codes, and regulations, in connection with the execution of the work.

10. Qualifications:

a. The Contractor services shall be performed by trained and qualified personnel and performed in accordance with manufacturer’s guidelines.

b. The laboratory shall have environmental microbiology accreditation by a nationally recognized accrediting body, such as EMLAP, NELAP, etc.

c. The testing laboratory processing the water samples for AAMI compliance with water quality shall be proficient at performing water quality AAMI compliance cultures from environmental samples.

d. The contractor shall be certified by the Environmental Protection Agency or a State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic).

11. Contractor Furnished Material:

a. The Contractor shall furnish all supplies, labor, materials, and equipment necessary for this service. No Government property will be provided.

b. The Contractor is responsible for cleaning up and removal of all trash and debris created during testing.

c. The Contractor shall be responsible for any damage to property whether personal, private or government owned during performance of these services. The Contractor shall be responsible for the actions of their workers.

d. The Contractor shall provide all safety equipment and personal protective equipment for their employees outside of the AVAHCS -SPS areas.

12. Key Personnel:

The Contractor shall identify one remote full-time manager or supervisor during all scheduled working hours to ensure compliance with the contract specifications.

Additionally, key personnel shall be able to respond to agency needs in instances where services are needed outside of normal hours of operation to include weekends and holidays. The Contractor shall furnish the COR with contact information (phone number, e-mail, etc.) for key personnel.

Any personnel the contractor offers as substitutes shall have the ability and qualifications equal to or better than personnel being replaced. The substitution of key personnel shall be submitted to the COR and CO within 14 calendar days prior to making any change in key personnel. This request shall be written and provide a detailed explanation of the circumstances necessitating the proposed substitution.

13. Environmental Control Restrictions The Contractor shall ensure proper protective equipment is used prior to entry into the Sterile Processing area as posted on entry doors. This equipment must be always worn while within the processing area.

The The Contractor shall have escorted access into the facility. All work shall be completed during standard business hours and coordinated with Contracting Officer Representative “COR” in coordination with “Sterile Processing” supervisor and Biomed department prior to arrival.

14. Points of Contact:

Name: Dianyelle Hawkins Email: Dianyelle.Hawkins@va.gov Phone:318-466-4284

Location of work to completed Address: Alexandria Lusianan VA Medical Center 2495 Shreveport Hwy Pineville, LA 71360

All Requirements for testing are broken down in Appendix A and shall follow AAMI ST108 Guidelines

Attachment A

*If a bacteria filter is included in the water return line, samples should be drawn pre- and post- filter.

15. Period of Performance: Working hours for this contract are between 6:00 pm to 4:30 am, Monday through Friday excluding weekends and federal holidays.

VA follows all Federal holidays that are sent by law (USC Title 5 Section 6103). The Government hereby provided notice, and the Contractor hereby acknowledges receipt that Government personnel observe the listed days as holidays:

New Year’s Day January 1 Martin Luther King Jr.’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 14 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25 When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by the US government agencies.

In addition to the days designated as holidays, the Government observes the following days:

- Any other day designated by Executive Order

- Any other day designated by the President’s Proclamation; and

- Any other day designated by Federal Statute Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-month optional performance periods. The Period of Performance reads as follows:

Base Year Nov 27, 2025 thru Nov 26, 2026 Option 1 Nov 27, 2026, thru Nov 26, 2027 Option 2 Nov 27, 2027, thru Nov 26, 2028 Option 3 Nov 27, 2028, thru Nov 26, 2029 Option 4 Nov 27, 2029, thru Nov 26, 2030

16. Invoices: Offeror May submit invoices for any complete and government accepted items on the Price Schedule. See VAAR Clause 852.232-72, Electronic Submission of Payment Requests for invoicing procedures. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer’s Representative (COR). A properly prepared invoice will contain:

a) Invoice Number and Date

b) Contractor’s Name and Address

c) Accurate Purchase Order Number

d) Supply or Service provided

e) Total Amount Due

Payments shall be made in accordance with the Prompt Payment Act out of the Government annual appropriate funds obligated in a task order which will be issued after the contract is awarded.

Note: Invoices that are not in compliance with the aforementioned requirements under this paragraph will be rejected for payments and required to be resubmitted

End of Statement of Work

See attached document: Water Testing Drawings.

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