36C24925Q0255 0003.pdf

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)

1 5

Department of Veterans Affairs Network Contracting Office 9 1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

Network Contracting Office 9 Department of Veterans Affairs 1639 Medical Center Parkway Suite 204 Murfreesboro TN 37129

To all Offerors/Bidders

36C24925Q0255

04-24-2025

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 05-14-2025 16:00 CDT

The purpose of this amendment is to share questions and answers, remove the Period of Performance from the Statement of Work, and extend the solicitation.

Quotes are due by 4:00pm CT on May 14, 2025.

It is advised that interested parties conduct sites visits to obtain all necessary information to provide accurate quotes. Site visits can be arranged by emailing Rachel Hall at Rachel.Hally7@va.gov and Kimberly Coleman at KimberlyJ.Coleman2@va.gov.

Elyse N. McVey Contracting Officer

Lexington VA Health Care System Sterile Processing Service (SPS)

Statement of Work Water Quality Monitoring/Testing

1. Scope of Work

1.1 The Lexington VA Health Care System Sterile Processing Service (SPS) department has need of water testing services for water used in the processing of medical devices. This testing is to put the department in compliance with AAMI ST108 Water for the Processing of Medical Devices and VHA Directive 1116(2) Sterile Processing Service.

1.2 The vendor shall follow the Water Quality Management Plan for the SPS department of the Lexington VA Health Care System.

1.3 The testing shall include all tests required at each sample site for utility water, critical water, and steam.

1.4 The testing shall be conducted at the required frequencies of each test and sample site.

1.5 Monthly samples to be taken are 24. Quarterly samples to be taken are 38. Annual samples to be taken are 9. Parameters to be tested are to be in accordance with the Water Quality Management Plan for the SPS department of the Lexington VA Health Care System and AAMI ST108 Water for the Processing of Medical Devices.

1.6 One-time service of sample port installation. Sample ports shall be installed at locations determined by the the Water Quality Management Plan for the SPS department of the Lexington VA Health Care System and in conjunction with facility plumbing.

1.7 Sample ports installed shall be 13 copper line ports and 5 PVC line ports.

2. Qualifications:

2.1 The vendor shall be a subject matter expert on water quality and sample collection for the reprocessing of medical devices.

2.2 The vendor shall be a subject matter expert on AAMI ST108 Water for the Processing of

Medical Devices.

2.3 The vendor shall have the ability to collect all needed samples from all sample ports and equipment (regardless of the manufacturer of the equipment) used at the facility.

3. Deliverables and Delivery Schedule

3.1 One-time service of sample port installation. Sample ports shall be installed at locations determined by the Water Quality Management Plan for the Sterile Processing department of the Lexington VA Health Care System and in conjunction with facility plumbing.

3.2 Sample ports installed shall be 13 copper line ports and 5 PVC line ports.

3.3 The vendor shall schedule each site visit at the facility through the CORs.

3.4 Site visits will be scheduled during normal business hours of 7:30am to 4:00pm. The SPS department will be closed on weekends and all federal holidays and any other holidays designated by the President of the United States.

3.5 The vendor shall be responsible for sample collection and delivery of the sample to the laboratory.

3.6 Monthly samples to be taken are 24. Quarterly samples to be taken are 38. Annual samples to be taken are 9. Parameters to be tested are to be in accordance with the Water Quality Management Plan for the SPS department of the Lexington VA Health Care System and AAMI ST108 Water for the Processing of Medical Devices.

3.7 The Annual Performance Qualification testing shall be conducted in conjuction with the first monthly testing of each contract year.

3.8 Quarterly testing shall be conducted every 3 months.

4. Documentation

4.1 The vendor shall provide test results electronically via email documentation to the CORs

(kimberlyj.coleman2@va.gov and rachel.hall7@va.gov).

5. Invoicing Instructions

5.1 The invoices for this service shall be submitted monthly.

5.2 The vendor shall submit all invoices to the Invoice Payment Processing System (IPPS).

(End of Statement of Work) mailto:kimberlyj.coleman2@va.gov mailto:rachel.hall7@va.gov

QUESTIONS AND ANSWERS, CHANGES 5/2/2025

Answers are in Bold italics typeface.

1. Please provide the “Water Quality Management Plan for the SPS department of the Lexington VA Health Care System” that is referenced in 1.2 and other places as well.

The Water Quality Management Plan for the SPS department of the Lexington VA Health Care System does not exceed or contain different standards of AAMI ST108. It will be provided to the awarded quoter.

2. We are working to determine the specific testing requirements; however, the solicitation does not clearly indicate which tables or testing standards are required at which intervals. Any clarification on this would be greatly appreciated. They can find the standards in Association for the Advancement of Medical Instrumentation AAMI ST108 – Water for processing of medical devices.

3. The BPA ceiling is based on the Independent Government Cost Estimate and will be determined after receipt of all quotes.

4. The RFQ is being extended to Wednesday, May 14, 2025 at 4:00 pm CT. It is advised that interested parties conduct site visits to obtain all necessary information to provide accurate quotes. Site visits can be arranged by sending an email to Rachel Hall at Rachel.Hally7@va.gov and Kimberly Coleman at KimberlyJ.Coleman2@va.gov.

5. The Period of Performance has been removed from the Statement of Work.

QUESTIONS AND ANSWERS FROM 4/25/25 AMENDMENT 0001 ARE FOLLOWING FOR

YOUR CONVENIENCE.

QUESTIONS AND ANSWERS 4/25/2025

Answers are in Bold italics typeface.

1. The number of samples to be taken are listed:

Monthly – 24

Quarterly – 38 mailto:Rachel.Hally7@va.gov mailto:KimberlyJ.Coleman2@va.gov

Annual – 9

a. Can you please confirm that the 38 quarterly samples are additional, and do not include the 24 monthly samples? ADDITIONAL

b. Can you please break down the number of Utility Water and Steam samples to be taken quarterly?

Utility cold water quarterly: 5 sample locations – 1 test, 2 sample locations

– 5 tests.

Utility hot water quarterly: 5 sample locations – 1 test, 2 sample locations – 5 tests.

Steam quarterly: 5 sample locations – 4 tests AERs quarterly: 8 sample locations – 5 tests

c. For the 9 annual samples, can you please specify the number of critical, utility and steam samples?

Utility cold water annual: 2 sample locations – 17 tests.

Utility hot water annual: 2 sample locations – 17 tests.

Steam annual: 2 sample locations – 16 tests.

Critical water annual: 3 sample locations – 19 tests.

d. Of the 18 sample ports to be installed, are any of them steam sample ports? NO.

2. Size of pipe and material of pipe needing to be tapped. The distance will determine quantities, cost, etc. 13 copper line ports and 5 PVC line ports

3. Location of the nearest valve to isolate the line and all areas it will affect. If not, we have live tap options available. *UNKNOWN

4. Total amount and tap sizes needed. *UNKNOWN

5. Will this work be done during daytime hours or during premium time? DAYTIME

6. Footage of pipeline (if any) needing to be runs to the area served. *UNKNOWN

7. What materials and connections will be approved and this location? *UNKNOWN

*UNKNOWN: “Due to the extensive amount and variety of testing is why we put in the sow the vendor needs to be a subject matter expert on AAMI ST108. For the questions with this answer, the vendor would have to look at this on site.”