Sources Sought.docx

SUBJECT*

Sterile Processing Service (SPS) Water Testing.

GENERAL INFORMATION

SET-ASIDE

NCO 17 North Texas Healthcare System Regional Procurement Office West (RPO-W) 124 E. Hwy 67, Suite 100 Duncanville TX 75137

POINT OF CONTACT*

Contract Specialist Ivan Torres ivan.torres1@va.gov

PLACE OF PERFORMANCE

Olin E. Teague Veterans' Center

CTVHCS Sterile Processing Service

1901 Veterans Memorial Drive

Temple TX

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 not a request for quotes; the Government is seeking information for market research purposes only.

The CTVHCS Sterile Processing Service has established 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.

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, Memorandum from Assistant Under Secretary for Health for Operations (10N) dated August 28th, 2020 requiring Sterile Processing service water testing Reference guidance in current AAMI ST108: 2023 and various equipment Instructions for Use (IFU) and Steris equipment IFU.

Use of secure password protected web-based reporting with history of reports maintained on vendor database and exportable as excel and pdf documents highly preferred to paper based reporting.

CTVHCS intent to make this water testing for two physical locations (Temple and Austin) that each have two internal locations in one contract and to fully make requirement “turnkey” possible.

1. Water testing will be conducted monthly and quarterly. Vendor needs to include option for additional year. Vendor will come to CTVHCS Temple and Austin Sterile Processing locations to take water samples in secured areas of the CTVHCS Sterile Processing Service areas. Utility and Critical water will be tested. Reports will be supplied electronically and hard copy.

2. CTVHSC-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: 2023.

3. Sampling locations for SPS Water as listed in below chart. Sampling should be performed as listed in AAMMI ST108; H.5.2 Water sampling Technique.

4. A total of 22 samples will be collected each month for critical water, and 6 each quarter for utility water, for the testing described above:

Point of Generation (POG) (Reverse Osmosis) RO x 1 Deionized (DI) still x 1

POG

Point of Use (POU) DI x 1 RO x 4 Medivators x 4 (minus endotoxin) Ultrasonics x 2

POU

Decon x 4

POG

RO x 1

POG

POU

RO x 1

Medivators x 2 (minus endotoxin)

POU

GI x 1

Decon x 1

5. SCHEDULE OF SUPPLIES:

a. Contractor shall supply all sampling supplies, containers, and shipping labels. Contractor will supply training as needed for emergency samples to be collected and shipped. Contractor shall pay 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. Containers must be sterile, appropriate for the analysis, properly preserved, and ready for prompt transportation to the laboratory under strict chain of custody procedures. Contractor required to 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.

6. Sample/specimen Analysis and Reporting:

a. The testing laboratory processing the water samples for AAMI compliance with water quality must be certified by the Centers for Disease Control and Prevention (CDC) Environmental AAMI compliance with water quality Isolation Techniques Evaluation (ELITE) program as proficient at performing the culture of AAMI compliance with water quality from environmental samples.

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

ii. Endotoxin testing must be in compliance with use of Limulus Amoebocyte Lysate testing as listed in AAMI ST108: 2023

Per Association for the Advancement of Medical Instrumentation (AAMI) ST108: 2023

3.30 endotoxin: High-molecular-weight complex that is associated with the cell wall of Gram-negative bacteria, is pyrogenic in humans and specifically interacts with Limulus amoebocyte lysate (LAL). See also bacterial endotoxins test (BET) and pyrogen.

3.31 endotoxin unit (EU): Standard unit of measure for endotoxin activity initially established relative to the activity contained in 0.2 nanograms of the U.S. Reference Standard Endotoxin Lot EC-2 (United States Pharmacopeia [USP] standard reference material).

NOTE—FDA’s reference endotoxin EC-6, USP Lot G, and the World Health Organization’s primary international endotoxin standard (IS) are sublots of the same endotoxin preparation, making the EU and IU (International Unit) equal (Poole, et al., 1997).

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

c. Contractor required to provide all sample analysis reports via e-mail to identified COR and Central Texas Veterans Health Care System Point of Contact.

d. Contractor required shall provide water testing services no less than once per month and more frequent if necessary to treat water or provide maintenance on equipment. Successive stops between testing shall not exceed 35 calendar days.

e. Contractor required to make notification 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 CTVHCS required complete notification process.

f. 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 CTVHCS SPS AAMI water quality sampling results reporting form. Sample analysis reports must be provided within 15 calendar days of the lab receiving the samples. If the 15th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day.

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

h. Required- collection of samples will be performed in full compliance with facility PPE practice and policy. Collection team will be escorted into SPS restricted access areas.

i. Required- unscheduled Event related collections will be required to be collected on weekends and federal holidays to be performed on federal holidays.

j. Reports must include reference material and include previous test results to note trend of water quality with visual aids /graphs. Reports and materials need to be both electronic and hard copy/paper. POCs will be provided for electronic access. Electronic access training of VA POCs required.

k. Required- Assistance with interpretation of reports and creating effective plan of action consultation required.

7. Contractor shall provide water testing equipment – 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.

8. REQUIRED-Sampling for SPS water quality of Utility and Critical water:

a. Laboratory and Chemical Analysis:

i. Requirements for testing per ST108 ST108 2023 A.3 Quality Characteristics

a) pH

b) Total alkalinity

c) Water hardness

d) Bacterial content

e) Endotoxin content

f) Total organic carbon

g) Water temperature

h) Ionic contaminants (Conductivity) (annual requirement)

i) Corrosive Agents

j) Scaling Agents

Appendix A has complete breakdown of labs and parameters.

ii. Requirements and Procedures for Sampling of SPS water lines for CFU and Endotoxin: The contractor must be certified by the Environmental Protection Agency or a State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic). The contractor shall utilize the Standard Spread Plate Method 9215C using R2A agar. The contractor will provide an outline of their actual testing procedures. Proof of certification and outline of actual testing procedures must be provided before acceptance of the contract. Sampling results will report the number of colony forming units of heterotrophic water bacteria per milliliter of water (cfu/ml).

iii. Bacteria in water readings of less than 1CFU may be recorded as <1CFU. Critical water quality readings greater than <9 cfu/ml or greater are required to be immediately (<24 hours notified by both telephone and email to identified CTVHCS staff.

iv. Requirement -Utility water with bacteria in water findings of <195 or greater will require immediate (<24 hours) notification by both telephone and email.

v. All readings greater than 1CFU/ML should be quantified in whole numbers...or greater than 500 may be recorded as <10 cfu/ml or > 500 cfu/ml.

vi. REQUIRED- Sampling will 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: 2023.

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

b. Contractor shall provide all sample analysis reports via e-mail to the COR and the assigned Points of Contact within the CTVHCS -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 safe, within parameters established.

9. REQUIRED- Contractor takes all responsibility of their staff while on CTVHCS property. Contractor staff will be escorted in all restricted areas of SPS. All Contractor staff will be required to wear full PPE supplied by the CTVHCS SPS, no exceptions.

10. Period of Performance:

a. Base period beginning June 17, 2024, to June 16, 2025.

b. Option Year 1 June 17, 2025, to June 16, 2026.

11. The C & A requirements do not apply, and a Security Accreditation Package is not required.

12. Summary: The CTVHCS Sterile Processing Service 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.

13. Qualifications:

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

14. 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. Contractor responsible for clean-up and removal of all trash and debris created during installation or maintaining system.

c. Contractor responsible for any damage to property whether personal, private or government owned. Contractor responsible for actions of their workers.

d. Contractor to provide all safety equipment and personal protective equipment for their employees outside of the CTVHCS-SPS areas.

15. Work Hours: The following terms have the following meanings and are applicable to this contract:

16. Normal hours of coverage are Monday through Saturday from 7:00 am to 6:30 pm, excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee. CTVHCS Infection Prevention and Safety will provide Risk Assessment and guidance for working in hospital areas that is required to be followed.

i. Federal Holidays observed by Veterans Health Administration are:

17. Security:

a. The certification and accreditation (C&A) do not apply.

b. The Contractor’s field service employee will wear visible identification issued by the VA Police Service.

18. Identification, Parking, Smoking and VA Regulations:

a. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Service. The CTVHCS will not validate or make reimbursements for parking violations to the Contractor under any conditions. Smoking is prohibited inside any buildings at the CTVHCS.

19. Possession of weapons, illegal drugs & alcohol is prohibited.

20. Enclosed containers, including tool kits, shall be subject to search.

21. Points of Contact: N/A

22. Additional Notes:

a. Information System Officer, Information Protection: The contractor will not have access to VA Desktop computers. They will not have access to online resources belonging to the VA or the U.S. government.

b. Privacy Officer: The Contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

Records Manager:

c. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

d. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

e. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

f. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

g. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

h. The Government Agency owns the rights to all data/records produced as part of this contract.

i. 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.

j. 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.].

k. 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.

l. 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.

23. NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Central Texas Veterans Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Central Texas Veterans Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Central Texas Veterans Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Central Texas Veterans Health Care System control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

24. Appendix A.

The North American Industry Classification System (NAICS) is 541690 -Other Scientific and Technical Consulting Services Service Code (PSC) is H146 Quality Control- Water Purification and Sewage Treatment Equipment

Responses to this notice shall include company/individual name, size status for the above reference NAICS code, a service capability statement, SAM Entity Unique Identifier (EUI), DUNS Number, address, point of contact, and examples of similar facilities to which similar services have been provided to. Contractors should provide information on whether they are certified SDVOSB, VOSB, Hub zone, 8(a), women-owned concern. If standard company brochures are supplied as a response to this Source Sought, ensure that additional information tailored to this notice is included.

A solicitation is not currently available. If a solicitation is issued, it will be announced on the Contract Opportunities website https://sam.gov at a later date, and all interested parties must respond to that solicitation announcement separately from the response to this announcement. Contractors must be registered in the System for Award Management (SAM); see the website https://www.sam.gov for registration information.

Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owners?

If you are in GSA, please provide the schedule and contract number.

Responses to this notice must be submitted via email to ivan.torres1@va.gov no later than May 21, 2024, at 3:00 pm CT. No telephone inquiries will be accepted.

DISCLAIMER

This RFI is issued only for information and planning purposes and does not constitute a solicitation. All information received in response to this Sourced Sought Notice marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought Notice.

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