36C25025Q0419 0001.docx

36C25025Q0419 0001

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF

PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED

STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF

CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 04-17-2025 515-25-3-390-0673 None Department of Veterans Affairs Network Contracting Office (NCO) 10 6100 Oak Tree Blvd., Suite 490 Independence OH 44131 Department of Veterans Affairs Network Contracting Office (NCO) 10 6100 Oak Tree Blvd., Suite 490 Independence OH 44131 To all Offerors/Bidders

36C25025Q0419 04-10-2025

X X X 515-3650162-390-854100-2660 0100555X9 X One (1) The purpose of this modification is to answer questions posed by contractors and to update the Statement of Work accordingly. Please see page two (2).

The due date for offers remains unchanged.

Kristina L. Peart Contracting Officer Contractor Questions Question 1: Could the NAICS code be changed to 221310 rather than 238220?

Answer 1: No, the NIACS shall remain 238220. NAICS 238220 is broadly defined as Plumbing, Heating, and Air-Conditioning Contractors, however it is narrowed to more specific parameters under its corresponding index entries. One of these index entries is water system balancing and testing contractors. As this contract is for water testing, NAICS 238220 was deemed a suitable fit.

Question 2: Can FAR 52.219-14 be removed from the solicitation?

Answer 2: This solicitation is set-aside for Small Businesses. As prescribed in 19.507(e), FAR 52.219-14(c)(1) is to be inserted in “contracts that have been set aside for any of the small business concerns identified in 19.000(a)(3).” This clause shall not be removed.

Question 3: Could the contractor provide a turnaround time of 7-10 business days for sterile processing samples except for bacteria (HPC) and endotoxin which could be provided in 2 business days?

Answer 3: We are happy to accept results of any samples prior to the 5 business deadline stated in the SOW

Question 4: The SOW Specific Task #7 mentions the creation of a Water management program. What Clin should we include this pricing in? Can a Clin 0005 be included to encapsulate the cost of this development? Additionally, does the VA require program facilitation post Program development.

Answer 4: Upon further review, this shall be removed from the SOW. An updated SOW has been attached.

SOW Title: Sterile Processing Service (SPS) Water and Steam Testing Background: The Battle Creek VA Medical Center (BCVAMC) is required to complete testing on all water and steam systems utilize in the reprocessing of reusable medical devices. Water impurities can have adverse effects on medical devices and patient outcomes. The requirements of Association for the Advancement of Medical Instrumentation (AAMI) ST108: Water for the Processing of Medical Devices are intended to mitigate the risks associated with water identified to be in improper quality.

Scope: The BCVAMC requires a contract for SPS water and steam testing to meet the criteria of AAMI ST108 Reprocessing of Reusable Medical Equipment and Veterans Health Administration (VHA) Directive 1116(2) Sterile Processing Services at the BCVAMC and Wyoming VA Clinic, located at 5500 Armstrong Rd, Battle Creek, MI and 5838 Metro Way, Wyoming, MI, respectively. Services shall be in accordance with the terms, conditions, provisions and schedule of the contract.

Specific Tasks for Testing-Deliverable Product:

1. Contractor shall provide all labor, materials, equipment, transportation, lodging and supervision necessary to collect appropriate samples and deliver to a lab meeting requirement for processing of AAMI ST108.

2. Contractor shall provide training to SPS and Engineering personnel on AAMI ST108 requirements and responsibilities within one (1) week of contract award.

3. Contractor shall be escorted for all sample collection, either Chief of SPS or Water Safety Engineer shall meet with the collector before any samples are collected.

4. Tester shall be proficient in AAMI ST108 testing methods and procedures.

5. Contractor shall collect all samples utilizing aseptic technique to prevent contamination; gloves shall be worn, sample container cap shall not be laid down, sample container mouth shall not encounter anything. All sample ports shall be flushed for a minimum of 5 minutes prior to collecting any samples. Samples shall be collected before disinfection of the water treatment system. Sample ports will be treated with a general disinfectant such as alcohol and be completely dry prior to collecting sample. Do not use bleach or other disinfectant solutions on sample ports prior to sample collection. Do not contaminate sample port or sample container while collecting samples. The collection container shall not be made of polypropylene. At least 100 to 300ml of water should be collected per sample. To prevent bacterial replication samples shall be placed on ice or at 4°C until delivered to the laboratory for testing. Results should be provided in five (5) calendar days of them being received by the lab.

6. Contractor is to provide emergency service for retesting of out of parameter testing and testing five (5) calendar days post disinfection.

7. Testing shall be in alignment with VA and industry standards and guidance, including the AAMI ST108-2023 Water for the Reprocessing of Medical Devices ii. Association of periOperative Registered Nurses (AORN) Guideline for Cleaning and Care of Surgical Instruments (https://www.aami.org/standards/featured-standards/aami-st108).

Table 1: AAMI ST108 Utility Water, Critical Water, and Steam Testing

Utility Water

40 Original Samples for Wyoming/year 12 Retest/year

Critical Water

156 Original Samples for Wyoming/year 55 Retest/year

Steam

8 Original Samples for Wyoming/year 2 Retest/year

1:pH, Alkalinity, TOC, Aluminum, Conductivity, Hardness, Copper, Iron, Manganese, Nitrate, Phosphate, Sulfate, Silicate, Chloride & Zinc (See Table 4 AAMI ST108 for required units)

8. Conduct one Table 2 test on the first of August each year at each location with 1 retest per location if needed.

Table 2: “Table 2”—Categories and performance qualification levels of water quality for medical device processing Water Quality Measurement @ 25 °C:

Total Alkalinity, Bacteria, Endotoxin, Total Organic Carbon (TOC), Color and Turbidity, Ionic Contaminants, Aluminum, Chloride, Conductivity, Copper, Iron, Manganese, Nitrate, Phosphate, Sulfate, Silicate, Total Hardness, Zinc

Performance: The Government will document performance in accordance with deliverables. Any report will become a part of the supporting documentation for any contractual action.

Security Requirements: Contractor will not have access to VA Sensitive Information, patient records, or data.

General Requirements

1. All on-site work shall be coordinated with COR, Chief of SPS, or Water Safety Engineer at least seven (7) days prior to performing services.

2. Water testing shall be done during normal business hours 0730-1600 ET Monday through Friday.

3. The contractor shall respond to routine communications within 24 hours on business days and 48 hours on holidays/weekends.

4. Situations requiring more frequent analysis and/or special testing, other than the specified requirements, may arise. The contractor shall not perform any extra cost work without written authorization from the contracting officer.

5. Any deficiencies or problems noted with VA test results or with the water treatment system test results are to be reported to the COR and SPS as soon as possible but no later than 4 hours after test results are received. The Contractor shall not perform any work outside of the scope of this contract unless they have been issued a separate Purchase Order to cover that work.

Deliverables

1. The contractor shall provide complete written reports within five (5) business days after each analysis and inspection.

a. The reports shall include all test results, the date of the test, testing parameters, recommendations, and a review with the COR.

b. Each report shall highlight the results with a green for pass and red for fail, indicating whether the results pass or fail the parameters specified in AAMI ST108.

c. For any products utilized in the testing process, the following shall be documented on the report: name, ingredients, control range, test procedures, physical state (liquid, powder, etc.), container size, method of delivery, compatibility with present materials being used, catalog data, Material Safety Data Sheets (MSDS) sheets.

2. The reports shall be emailed to the COR.

Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI): The BCVAMC will not furnish parts and/or test equipment for the performance of this contract. It is the responsibility of the contractor to bring the appropriate equipment; and/or supplies necessary to complete the work as required per this contract.

Other Pertinent Information or Special Considerations: All work shall be performed by personnel qualified to work on the specific equipment. All work performed shall be compliant with AAMI ST108 guidelines and shall be designed to assure that the BCVAMC is providing the best possible water to process reusable medical equipment.

Place of Performance: The Department of Veterans Affairs BCVAMC located at 5500 Armstrong Rd, Battle Creek, MI, and Wyoming VA Clinic located at 5838 Metro Way, Wyoming, MI. AAMI ST108 testing shall take place in Sterile Processing department, Sterile Processing Reverse Osmosis mechanical room, and GI Procedures reprocessing area.