36C24221Q0017 0001.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 NUMBERE

D 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 amendmen t, 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) 09-04-2020

NONE

Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227 Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227 To all Offerors/Bidders

36C24221Q0017 09-04-2020

X X X

The SOW is hereby amended as follows with changes under the General Requirements Section Only.

See continuation Pages.

Joseph Cellino Contracting Officer

CONTINUATION PAGE

B.2 STATEMENT OF WORK

Statement of Work Biomedical Engineering Water and Dialysate Testing

Background:

The Syracuse VA Medical Center, 800 Irving Avenue, Syracuse, NY 13210-2716, requires an indefinite delivery, indefinite quantity (IDIQ) Firm Fixed Price (FFP) contract for water and dialysate testing. This testing is used in the dialysis unit for compliance with VA and AAMI standards for dialysis water. The fluid test samples will be sent out by the Syracuse VA Medical Center for analysis by the contractor.

Objectives:

The objective is for the Syracuse VA Medical Center to improve patient care and safety by testing the water and dialysate to VA and AAMI standards in the dialysis unit. The IDIQ contract will have a 5- year ordering period to reduce testing costs, improve results turn-around time, and ensure patient safety.

General Requirements:

The contractor must comply with the following general requirements:

a) The Contractor shall comply with Federal, State, and Local Laws, plus any Federal Regulations as applicable to the performance of this contract.

b) The Contractor shall not accept any instructions issued by any person employed by the U. S. Government, other than: the Contracting Officer (CO), or the Contracting Officers Technical Representative (COR), all acting within the limits of their authority.

c) The Contractor shall be accredited to perform all tests in accordance with AAMI guidelines. Contractor shall have and maintain ISO/IEC 17025:2017 accreditation throughout entire contract period. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance.

d) The Contractor shall use United Parcel Service (UPS) for shipping to and from the laboratory facility and the Syracuse VA Medical Center.

e) The Contractor shall be required to perform the following tests at the notice of the CO or COR:

i. Water Analysis Panel to the AAMI standard 23500:2011 Guidance for preparation and quality management of fluids for hemodialysis and related therapies for aluminum, copper, fluoride, lead, nitrate, sulfate, zinc, calcium, magnesium, potassium, and sodium.

ii. Water Analysis Panel to the AAMI standard 23500:2011 Guidance for preparation and quality management of fluids for hemodialysis and related therapies for trace metals, specifically antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, and thallium.

iii. LAL Pyrogen testing for bacterial endotoxins to the AAMI standard 23500:2011 Guidance for preparation and quality management of fluids for hemodialysis and related therapies with a maximum allowable limit of <0.25 EU/ml for water and <0.5 EU/ml for dialysate.

iv. Colony Count for microbial purity of the water to the AAMI standard 23500:2011 Guidance for preparation and quality management of fluids for hemodialysis and related therapies with a maximum allowable limit of <100 CFU/ml.

v. Colony Count for microbial purity of the dialysate to the AAMI standard 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies with a maximum allowable limit of <100 CFU/ml.

f) The Contractor shall electronically report test results within forty-eight (48) hours of receiving samples to the COR; within seven (7) days for colony counts.

Statement of Work:

The contractor will provide testing and reporting on the dialysis fluid samples performing all necessary tests collected and shipped through the Syracuse VA Medical Center. The contractor shall provide all testing containers and shipping to and from the laboratory facility through United Parcel Service (UPS). The contractor shall perform the following tests at the notice of the Syracuse VA Medical Center: Water Analysis Panel to the AAMI standard 23500:2011, LAL Pyrogen testing for bacterial endotoxins to the AAMI standard 23500:2011, Colony Count for microbial purity of the water to the AAMI standard 23500:2011, and Colony Count for microbial purity of the dialysate to the AAMI standard 11663:2009. The contract shall provide a report stating the tests performed and their results on the provided water samples within forty-eight (48) hours of receiving the samples, seven (7) days for colony counts. The contractor must have the skills, certification, and experience to be qualified to test and analyze the dialysis fluid samples.

Government Furnished Equipment:

The dialysis fluid test samples will be collected from the following government furnished equipment:

Estimated Ordering Quantities :

The Syracuse VA will place an estimated task order in the number of tests anticipated during the period specified on the task order. The number of tests in excess of what is included on the task order requires a modification to the task order.

Following completion of the task order period, any excess funds will be de-obligated from that task order.

Period of Performance:

The IDIQ ordering period is from 10/01/2020 through 09/30/2025.