36C26225Q0554 0002 - AMENDED RFQ - HEMODIALYSIS WATER TESTING.docx

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) 04-25-2025 None 36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815 To all Offerors/Bidders

36C26225Q0554 03-20-2025

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 05-01-2025 3:00 PM PDT X Please see next page for RFQ amendment details.

Michael Kahyai, - Contracting Officer

This solicitation is being amended for the following reasons;

1. The deadline for offers is being extended to 05-01-2025, 3:00PM Pacific Time.

2. Vendor Questions v2 document is added to provide responses to questions submitted by vendors.

3. Section III, Services to be Provided, paragraph F, Qualifications, of the SOW is revised to update Accreditations. The following accreditation is added as qualifications, Perry Johnson Laboratory Accreditation (PJLA), 23500-1:2024 - Preparation and quality management of fluids for hemodialysis and related therapies.

4. To add, ATTACHMENT F - ISO-23500-1:2024

STATEMENT OF WORK

HEMODIALYSIS WATER TESTING SERVICE

I. Scope: The contract shall provide services for hemodialysis water testing for VA Long Beach Healthcare System (VALBHCS). This includes the following test types, Bacteria/Colony Count and LAL/Endotoxin. Service must include all sample collection supplies, consumables and equipment necessary to perform this service.

II. Period of Performance: The period of performance will start shortly after award for a one (1) Year Base Period with the Government having the option to exercise four (4) one-year option periods for a total of five (5) years.

III. Services to be Provided:

a. Ongoing Support Services:

· The contractor shall be responsible for performing hemodialysis water testing services.

· All services must meet the standards of Association for the Advancement of Medical Instruments Technical Information Report (AAMI TIR-34) standard defined for the test below;

1. Bacteria/Colony count – 48-hour Incubation: 63 tests per month

2. LAL/Endotoxin: 63 tests per month

· All services/tests must be performed on a weekly/monthly basis.

b. Documentation: Vendor will provide individual results in a service report which describe services performed (in sufficient detail to be acceptable to the field inspectors of The Joint Commission). The following information must be provided in each report:

1) Date of service

2) Sample ID and serial #

3) Test name

4) Environmental results

5) Reference range

6) Vendor comments

Note: The completed service report must be approved and signed by Biomedical Engineering personnel or their representative. A copy of each report must be sent to the Lead Medical Instrument Technician (MIT), or with a designee of the MIT, i.e., a supervising official, using the agreed upon method of communication(s).

c. Labor: The vendor will provide all labor associated with the hemodialysis water testing defined in section III “Services to be Provided” of the SOW.

· All testing errors must be corrected by the contractor at a mutually agreed upon time and at no additional cost to the VA.

d. Response Times:

· LAL Endotoxin results: Must be reported within 48 hours post testing service date.

· Bacteria/Colony Count: Must be reported within 3-4 days post testing service date. Colony count testing will be reported on Sundays, holidays, or any day that testing is completed.

· Test results must be report by email, website or fax. If a website is used, users must be provided 24/7 access to the results of test.

· Failures or other testing issues must be communicated via phone support or email immediately upon identification.

· Test results that are ready prior to the stated report times must, upon completion, be reported immediately.

· The Contractor will notify VALBHCS immediately when any results action level is above the Alert Limit.

· Water cultures Max Level = 100 cfu/mL Action level = 50 cfu/mL

· Endotoxin LAL Max Level = 0.25 eu/mL Action level = 0.125 eu/mL

e. Parts:

· Sample Collection Supplies: All sample collection supplies defined as “Kit” must be included. The kit must include, shipping box, freezer pack, test tubes and bottles. These supplies are to be include in the pricing.

f. Qualifications: The contract must provide evidence of their most recent dialysis water testing service. This shall include evidence of bacterial, colony count and LAL/endotoxin testing service.

· Equipment: The contractor’s personnel must be capable of performing all hemodialysis water testing services on the equipment below.

· B-Braun Dialog+ Dialysis machine

· Phoenix 36X Gambro Dialysis machine

· Millenium HX Portable Reverse Osmosis machine

· Accreditation: The contractor’s laboratory must have the following accreditations;

· Perry Johnson Laboratory Accreditation (PJLA)

· 23500-1:2024 - Preparation and quality management of fluids for hemodialysis and related therapies

· ISO/IEC 17025 – Testing and Calibration Laboratories

IV. Hours of Coverage:

a. Normal hours of testing will be Monday through Friday from 8am to 5pm EST.

b. All services will be performed during stipulated hours of coverage unless requested or approved by Biomedical Engineering.

· Hours: Normal duty hours are 7:30 a.m. through 5:00 p.m., Monday through Friday, not including federal holidays. Whenever contact with a facility is required outside of normal duty hours, the Contractor shall coordinate these times with the designated COR, POC or designee.

c. Federal Holidays: In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”

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