S06 Response to Vendor Questions 36C26326Q1063 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 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)

09-02-2026

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

316 ROBERT STREET N, SUITE 506

SAINT PAUL MN 55101

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

316 ROBERT STREET N, SUITE 506

SAINT PAUL MN 55101

To all Offerors/Bidders

36C26326Q1063 08-26-2026

X

See following pages.

Jeffrey Brown Contracting Officer

VA-VHA-RPOC-2024-0033

The purpose of this amendment is to:

1.Respond to vendor questions, see vendor questions and VHA responses below.

2. Edit the Statement of Work (SOW). Changes to the SOW are highlighted.

Questions regarding solicitation 36C26326Q1063 Vendor questions in bold, VHA responses in red.

1. The SOW states that shipping and shipping-material costs are to be included in the testing CLINs; however, the Price/Cost Schedule contains a separate Return Shipping CLIN with an estimated quantity of 60 annually. Please clarify what costs should be included under the Return Shipping CLIN versus incorporated into the individual testing CLINs.

The return shipping line item shall be utilized for all samples, whether initial testing or retesting. The estimated quantity of 60 accounts for the expected testing and the unexpected retesting of samples. The SOW has been updated to reflect this.

2. Please confirm whether the ISO/IEC 17025:2017 accreditation scope submitted with the offer must specifically identify each analytical method/analyte required under AAMI 23500:2019 and AAMI ST108:2023.

Yes, the laboratory shall have ISO/IEC 17025:2017 accreditation that shows capability to perform testing according to AAMI 23500:2019 and AAMI ST108:2023 standards. The SOW has been updated to reflect this.

3. The historical Q&A states that there will generally be three batches for monthly testing. Please confirm whether the estimated 60 annual Return Shipping units represent approximately 60 sample shipments, or whether multiple CLIN tests may be consolidated into individual shipments.

The 60 quantities of return shipments represent either individual shipments of single tests or consolidated/bulk shipments of multiple tests.

4. The SOW requires results within four calendar days of test completion. Is there a maximum required turnaround time from receipt of the sample at the laboratory through completion of testing and issuance of the final report?

The turnaround time for the final report is as listed in the SOW.

5. For purposes of VAAR 852.219-75 limitations on subcontracting, please confirm whether commercial carrier shipping costs, sample containers, collection materials, and similar direct costs may be excluded from the subcontracting-percentage calculation when applicable under 13 CFR 125.6.

VAAR clause 852.219-75 is exclusive to the service portion of this contract, any incidental supply elements (e.g. shipping materials, sample containers) will not count towards meeting the 50% threshold in the clause.

6. In B.4, SOW, in section 5. Testing Services under b. 2. A., it states:

a. Kinetic Turbidimetric Method or Kinetic Chromogenic Method with a sensitivity range of 0.005-50 EU/mL Question: Will you accept a Kinetic Turbidimetric Method with a lower sensitivity range of 0.01 EU/ml instead of 0.005?

Yes. The SOW has been updated to reflect this.

B.4 STATEMENT OF WORK

DIALYSIS AAMI Requirements SPS AAMI Requirements

1. BACKGROUND

a. The Dialysis Department at VA Black Hills Health Care System (BHHCS) requires water and dialysate testing services that adhere to the current version of the Association for the Advancement of Medical Instrumentation (AAMI) Standards for Dialysis Water and Dialysate inclusive of, but not limited to, Colony Forming Units (CFU), Endotoxin Units (EU) and AAMI Chemical Testing under AAMI 23500:2019 and future revisions of AAMI standards. This testing will support government owned central & portable Reverse Osmosis (RO) systems and Hemodialysis machines in the Renal Dialysis Department at the Hot Springs VA Medical Center.

b. The Sterile Processing Service (SPS) Department at VA Black Hills Health Care System (BHHCS) requires water testing services that adhere to the current version of the Association for the Advancement of Medical Instrumentation (AAMI) Standards for Water for the Processing of Medical Devices inclusive of, but not limited to, Colony Forming Units (CFU), Endotoxin Units (EU) and AAMI Chemical Testing under AAMI ST108:2023 and any future revisions of AAMI standards. This testing will support government owned equipment units in the SPS Department at Fort Meade VA Medical Center and Hot Springs VA Medical Center.

2. OBJECTIVES

a. The contract effort goals are to provide appropriate sample collecting equipment, appropriate shipping material, shipping labels, water bottles and vials according to AAMI standards, and results of testing throughout the total contract period.

3. PLACE OF PERFORMANCE

a. Delivery of services in this case will be conducted at the following address:

· VA Black Hills Healthcare System

Hot Springs VA Center Renal Dialysis Department - HS111D 500 N Fifth St, Hot Springs, SD 57747

Fort Meade VA Center SPS Department – 118SPS 113 Comanche Rd, Fort Meade, SD 57741

Hot Springs VA Center SPS Department – HS118SPS 500 N Fifth St, Hot Springs, SD 57747

4. Laboratory Requirements

a. Laboratories, including external or subcontracted, conducting the assay for microbiological and chemical contaminants will present ISO/IEC 17025:2017 (General international requirements for the competence of testing and calibration laboratories) accreditation certificate with capability demonstrated with AAMI 23500:2019 and AAMI ST108:2023 standards.

b. Documented competency training of all qualified analysts in those tasks for which they have responsibility to perform the assay should be demonstrated to ensure that analyst maintains the appropriate skills and training to perform the assay to meet current ANSI/AAMI/ISO 23500-3:2019.

c. Documented competency training of all qualified analysts in those tasks for which they have responsibility to perform the assay should be demonstrated to ensure that analyst maintains the appropriate skills and training to perform the assay to meet current ANSI/AAMI ST108:2023.

5. Testing Services:

a. The following tests shall be compliant with AAMI 23500:2019 and any future revisions to the AAMI standards.

i. The Contractor shall perform the following testing as requested on samples delivered to them:

1. CFU/Colony Count

a. Tryptic Soy Agar (TSA) at an incubation temperature of 35 °C to 37 °C and an incubation time of 48 h with a sensitivity of 1 CFU/mL

2. Endotoxin Units

a. Kinetic Turbidimetric Method or Kinetic Chromogenic Method with a sensitivity range of 0.01-50 EU/mL

3. AAMI Chemical Water Panel

a. Aluminum

b. Antimony

c. Arsenic

d. Barium

e. Beryllium

f. Cadmium

g. Calcium

h. Chromium

i. Copper

j. Fluoride

k. Lead

l. Magnesium

m. Mercury

n. Nitrate (as N)

o. Potassium

p. Selenium

q. Silver

r. Sodium

s. Sulfate

t. Thallium

u. Total chlorine

v. Total Heavy Solids

w. Zinc

b. All testing is to be compliant with AAMI ST108:2023 and any future revisions to the AAMI standards.

i. The Contractor shall perform the following testing on samples delivered to them:

1. CFU/Colony Count

a. Tryptic Soy Agar (TSA) at an incubation temperature of 35 °C to 37 °C and an incubation time of 48 h with a sensitivity of 1 CFU/mL

2. Endotoxin Units

a. Kinetic Turbidimetric Method or Kinetic Chromogenic Method with a sensitivity range of 0.01-50 EU/mL

3. AAMI Ionic Contaminants Chemical Water Panel

a. Aluminum

b. Chloride

c. Conductivity

d. Copper

e. Iron

f. Manganese

g. Nitrate

h. Phosphate

i. Sulfate

j. Silicate

k. Total Hardness

l. Zinc

4. Water Quality

a. pH

b. Total Alkalinity

c. Total Organic Carbon

d. Conductivity

6. Training Services

a. The Contractor shall provide Instructions for Use (IFU) training and materials to VHA staff on proper sample taking techniques, this may be provided in person or remotely depending on the difficulty of the training.

7. SAMPLE COLLECTING EQUIPMENT

a. All equipment needed to appropriately collect samples of water and dialysate shall be provided to the Government by the Contractor throughout the life of the contract when requested by the Government via written or oral communication from the Government’s Point of Contacts (POC), Contracting Officer (CO) or Contracting Officer Representative (COR).

b. NOTE: The Government shall make do effort to avoid waste and excessive cost to the Contractor due to requests of sample collecting equipment, however, there shall not be a threshold on the amount of sample collecting equipment the Government is able to request.

c. The cost of sample collecting equipment will be included in the line items for testing services and not as a separate line item.

8. SHIPPING

a. The Contractor shall provide appropriate shipping materials to pack individual samples in a manner that maintains the integrity of the samples from shipping from the Government’s Facility to the Contractor’s Testing Facility.

b. For environment sensitive samples, the Contractor shall provide appropriate shipping materials to ensure that the samples’ integrity is not compromised during the shipping process.

c. The Contractor shall provide written confirmation to the Government POCs and COR when samples are received at the Contractor’s Testing Facility.

9. TEST RESULTS

a. All test results shall be associated with the specific device that was notated which the sample was collected from.

b. All results shall be accompanied by method used to attain result.

c. The Contractor shall provide an electronic PDF or hard copy of the test results to the Government’s POCs and COR within four (4) Calendar Days of test completion.

d. If any test results are determined to be equal to or exceeding action level as per AAMI Standards, the Contractor shall send a written alert to the Government’s POCs and COR on the same day.

e. The Contractor shall provide additional copies of the test results as requested by the Government.