Sources Sought 36C26326Q0885.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

NETWORK CONTRACTING OFFICE 23

316 ROBERT STREET N, SUITE 506

SAINT PAUL MN 55101

POINT OF CONTACT*

Contracting Officer Jeffrey Brown Jeffrey.Brown8@va.gov 651-293-3009

PLACE OF PERFORMANCE

Fort Meade and Hot Springs VA Clinics

South Dakota

POSTAL CODE

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Black Hills VA Healthcare System requires dialysis water, dialysate and SPS testing services in accordance with the draft Statement of Work (SOW) below.

This is a sources sought looking for vendors to perform the services per the SOW for market research purposes. No awards of a contract will be made from this announcement.

If you are a vendor that can complete the work described in the SOW with competitive pricing, please send your contact and organization information with a descriptive proof of capability to: Jeffrey.Brown8@va.gov on or before July 7th, 2026. Only emailed responses will be considered.

This sources sought is separate from sources sought # 36C26326Q0804 as the requirement has been expanded to include a significant amount of additional testing. A response to sources sought # 36C26326Q0804 will not be considered a response to this sources sought (#36C26326Q0885).

Additionally, please provide answers as appropriate to the following questions in the table below with your response to this sources sought. Failure to respond to the following questions may affect the acquisition strategy.

*If applicable, VAAR 852.219-75 VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction, will apply to the potential solicitation if set-aside for Veteran Owned Small-Businesses or Service Disabled Veteran Owned Small-Businesses.* *If applicable, FAR 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses.* Draft 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.

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 chromogenic with a sensitivity range of 0.005-50 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 this document with standard recommends for validations and quarterly collections (Table 2) and standard recommends for monthly monitoring (Table 4)

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 chromogenic with a sensitivity range of 0.005-50 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.

d. The cost of shipping and shipping materials will be included in the line items for testing services and not as a separate line item.

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 a 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.

Sources Sought Notice