NYH Dialysis Water Testing SOW Dec 2024 update.docx

STATEMENT OF WORK

A. GENERAL INFORMATION:

1. Project Title: VA New York Harbor Healthcare System (VA NYHHS) Dialysis Water Quality Analytical Testing Services.

2. Background: The VA New York Harbor Healthcare System has a requirement for Dialysis Water Quality Testing Services. Samples will be collected by the VA and shipped via overnight mail to the vendor’s laboratory for analysis from the following locations.

MANHATTAN VA Medical Center Department of Veterans Affairs New York Harbor Healthcare System 423 E. 23rd Street New York, NY 10010-5011

BROOKLYN VA Medical Center Department of Veterans Affairs New York Harbor Healthcare System 800 Poly Place Brooklyn, NY 11209-7104

3. Scope of Work:

a. The vendor shall provide adequate quantities of new, sterile sampling containers appropriate for the analyses to be performed. The vendor shall bear the cost of providing and shipping the containers to the VA at the inception of the contract term and as required thereafter. All containers shall have tamper-evident seals and shall conform to Association for the Advancement of Medical Instrumentation (AAMI) protocols in terms of capacity, preservatives (if any) and all other requirements and protocols.

b. The vendor shall provide portable ice packs, appropriate insulated shipping containers, sample labels, chain of custody forms and all other appurtenances necessary to facilitate sample collection by the VA.

c. The vendor shall have demonstrated experience with the specific processing and analysis of samples of dialysis water. The vendor must provide and maintain all required certifications to conduct testing in accordance with AAMI protocols. Vendor must have ISO/IEC 17025:2017 Accreditation.

d. The vendor must process all samples in accordance within designated holding times.

e. Samples collected by the VA may include but not necessarily be limited to water and dialysate samples from: main and portable reverse osmosis (RO) machines; dialysis machines; dialysis water wall outlets; post-disinfection samples from various locations; and samples of utility, product and distribution water from various locations. The laboratory must have capability to analyze these samples for the parameters indicated in the sampling schedule herein.

f. The vendor shall provide clear and comprehensive analytical reports including a comparison of sample results to the applicable thresholds and standards. Analytical reports shall be transmitted to designated VA contacts via email. The analytical reports shall have utilize an acceptable method of highlighting (i.e. bold font) any samples found to be “out of range” of acceptable limits.

4. Analytical Testing:

Contractor shall adhere to the following requirements. All samples shall be processed within 24 hours of receipt. Contractor shall provide adequate quantities of sterile sampling containers with tamper-proof seals. Containers shall be appropriate to the test method required.

4.1 Heterotrophic Plate Count (HPC) Bacteria Testing:

· Specimen is to be cultured using the spread-plate technique in accordance with ANSI/AAMI ISO 23500-1-2019 method.

· Results must be reported as total viable colony count of colony forming units per ml of fluid (CFU/ml).

· Contractor must provide results via email.

· Contractor must notify the designated New York Harbor VA Contracting Officer’s Representative (COR) immediately by phone and email upon receiving results that exceed the alert level as defined in the most recent standards. The COR will provide a phone number to contact in case of such an event.

· Alert levels are based on ANSI/AAMI 23500-1-2019 standards.

4.2 Endotoxin (LAL) Testing:

· Endotoxin tests must be FDA Approved using the Kinetic Limulus Amoebocyte Lysate (LAL) method.

· Test results must be reported in endotoxin units per ml (EU/ml).

· Contractor must notify the designated New York Harbor VA Contracting Officer’s Representative (COR) immediately by phone and email upon receiving results that exceed the alert level as defined in the most recent standards. The COR will provide a phone number to contact in case of such an event.

· Alert levels are based on ANSI/AAMI 23500-1-2019 standards.

4.3 AAMI Panel:

· The test method(s) utilized shall be sensitive enough to detect the maximum allowable contaminant levels from ANSI/AAMI/ISO 13959:2014 and 23500-1-2019 standards.

· Test for the following parameters:

4.4 Analytical Schedule:

The following indicates the maximum number and types of samples to be submitted by VA to the laboratory for processing. The schedule does not constitute a commitment for VA to submit a minimum number of samples. It is expected that “batches” of samples will be shipped approximately four (4) times per month (twice per month from each of our two medical centers).

Sampling Schedule: Dialysis Water Testing NOTE: All samples will be collected by VA personnel and shipped to the vendor laboratory via overnight mail. All sample collection bottles, shipping packaging (coolers), icepacks and other ancillary supplies needed for sampling shall be provided by the vendor at no additional cost.

Location

Collection Frequency

Brooklyn VA Dialysis Suite

Monthly

Monthly

Manhattan VA Dialysis Suite (Pickup)

Endotoxin

* AAMI parameters testing shall include: Specific Conductance, Flouride, Nitrate as N, Sulfate, Aluminum, Antimony, Arsenic, Barium, Beryllium, Cadmium, Calcium, Chromium, Copper, Lead, Magnesium, Potassium, Selenium, Silver, Sodium, Thallium, Zinc and Mercury.

5. Performance Period: Performance shall be for a period of one year, effective the date identified in block 3 of the SF1449 (Purchase Order award), with four option years.

Base: 3/1/2025 to 2/28/2026 OY1: 3/1/2026 to 2/28/2027 OY2: 3/1/2027 to 2/29/2028 OY3: 3/1/2028 to 2/28/2029 OY4: 3/1/2029 to 2/28/2030

6. Contract Type: Firm Fixed Price

7. Applicable Documents:

· VHA DIRECTIVE 1042.01 – “Veteran Dialysis Care”

· ANSI/AAMI RD52:2004, “Dialysate for Hemodialysis”

· ANSI/AAMI/ISO 13959:2014, “Water for Haemodialysis and Related Therapies”

· ANSI/AAMI ISO 23500-1-2019, “Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies”