J046--642-26-1-583-0011 | SEA 26545 | Deionized Water System Lease and PM&R Services

Department of Veteran Affairs Michael J Crescenz VA Medical Center

Performance Work Statement - Sterile Processing Service

Maintenance Service Contract for Deionized (DI) Water

1.0 Introduction

The Michael J Crescenz VA Medical Center, Sterile Processing Services (SPS) requires critical modifications to the existing DI water equipment supplied by Evoqua. These modifications will provide new equipment and additional tanks to adhere to the standards defined by Advancement of Medical Instrumentaiton (AAMI) ST-108.

This scope of work is to provide services contract for the initial installation, operations and maintenance service contract for Deionized (DI) Water for Sterile Processing Services areas (SPS) the VA Medical Center to be compliant with the standards defined in this performance work statement. This service contract will be issued as a 3-Year Service Contract.

The Contractor shall provide all personnel, equipment, materials, facilities, transportation, tools, water testing services, and supervision to perform these operations and maintenance services to adhere to AAMI ST-108.

2.0 Objective

The equipment installed under this contract will be part of a (3) year service maintenance contract. The vendor will be required to provide on-site maintenance to ensure all equipment maintenance and exchanges (DI units, filtration, UV sterilization) will process DI water to meet ST-108 standards.

Given the critical nature of the instruments SPS sterilizes, there is a direct impact on the operations of Surgery, Ear, Nose, & Throat (ENT), and Gastrointestinal (GI).

All work must be completed on Saturday. A fully operational and validated system must be completed in one day.

Scope

Design & Installation

Removal of existing Evoqua systems in SPS Mechanical Room. Refer to Attachment A for layout of existing equipment.

All Evoqua equipment removed will be disposed of off-site.

The VA supplied SPS DI water utilization will be the basis for design of the system.

The system will be designed to meet the DI water capacity where anion, cation, and carbon tanks will be replaced every 30 days. The system design is based on the most stringent conditions of high conductivity (total dissolved solids) for the in-coming water during the winter months and DI water usage of 11,000 gallons per month.

(2) carbon tanks

(9) exchange tanks

The existing DI pipe (1.5 inch diameter ) for the supply and the return will remain. Vendor will attach the system connections to the supply and return line.

The VA will create a smaller DI supply and return loop (3/4 ) for sinks #2 and #3. The loop will generate at the DI Skid and return at the skid. Vendor will provide the connections to the DI skid

System will provide primary filter and housing (20 inch) 5 micron

System will provide secondary filter and housing (20 inch) 1 micron

System will provide final filter and housing (20 inch) 0.2 micron

Bacteria destruct ultraviolet sterilization

Feed & final water quality sensor

Check valves on supply and return lines

Flow meter on supply and return lines

Main control panel to provide centralized, automated control and monitoring of the entire purification process. System will monitor water quality and manage maintenance cycles.Â

Recirculation pumps on supply and return lines

Test valves for water testing validation

Drain & isolation valves for maintenance

Check valves to present reverse flow within system

The exchange tanks will be placed in the SPS mechanical room. The remaining equipment will be supplied with a skid mount system placed outside the mechanical room. Hoses will be attached from the skid mount system to the tanks. The VA will provide the open wall section for these hose connections inside the mechanical room. See Sketch 1.

Vendor shall provide ST-108 compliant water testing services for Sterile Processing.

Commissioning

Inspect, test, and verify the system's performance to ensure it meets design objectives to consistently produce DI water to meet ST-108 standards

Qualifications & Inspection

Verifying the system is installed according to design standards.

Visual inspection, Pre-treatment checks, Performance tests for flow rate and water conductivity

Calibration of monitoring instruments

Final verification and on-site operator training

Functional Testing

Performance Testing:Â Measuring the system's flow rate and water conductivity to confirm it meets the required purity standards

Calibration:Â Calibrating all monitoring instruments, such as resistance meters and flow meters.

Integrated System Testing:Â Operating the entire system to ensure all parts work together correctly.

Post-Commissioning

Final Verification:Â A final confirmation that the system meets all established criteria and standards.

Initial Water testing at points of use on the DI system to meet ST-108 requirements. See Attachment B

Operator Training:Â Providing on-site training

Documentation:Â Documenting all test results and the entire commissioning process for future reference and compliance.

Monitoring & Break-in Period:Â A continuous water sampling and testing period, often 2-4 weeks) is sometimes recommended to monitor performance

Maintenance and Repair

All maintenance work shall ensure continuous system operation and compliance to ST-108

Routine checks and replacement of filter and UV lamps

Addressing leaks at hoses and connections

Pumps - replacing worn components

Resin Replacement/Regeneration: replace as required. Design is based on 30-day cycle. Should operation or incoming water conductivity affect higher utilization of tanks, these will be switched next day, which could occur on a weekend.

Instrument Calibration: Conductivity sensors and other instruments need periodic calibration to ensure accurate water quality monitoring.Â

Leak Checks: Inspect tanks and piping networks for leaks to prevent contamination and system downtime.Â

Sanitization: Periodically clean and flush the system to remove biofilms and prevent bacterial growth.Â

All work scheduled work will be performed Monday Friday 5AM 7AM. Any work requiring more that (2) hours shall be performed on a Saturday

Quarterly DI loop sanitization.

Water Testing Requirements

Vendor shall furnish all personnel, supervision, certifications, materials, equipment, facilities, results, and resources necessary for water sampling of all locations and frequencies outlined in Attachment B in accordance with ANSI/AAMI ST108 for Sterile Processing. The water quality required from this DI generation system is used for the various stages of medical device processing. Water test results validate system operation for water quality measurement values per ANSI/AAMI ST108 are outlined in Attachment B.

Aseptic technique should be used for water collection. This technique is  a set of procedures designed to prevent contamination from microorganisms, especially bacteria, viruses, and other pathogens. It's a crucial practice in healthcare, laboratory settings, and manufacturing to protect patients, personnel, and products from infections.Â

Sample taps should be wiped with alcohol and flushed for 5 minutes prior to retrieving samples. Collect all SPS Samples in accordance with ST-108

Bleach should never be used as a disinfectant.

Vendor will bring a calibrated pH meter as pH must be tested immediately at time of draw.

Containers must be sterile and should be of the required quality not to introduce contamination into the test sample. (eg. Pyrogen-Free, Polypropylene Free, endotoxin-free etc.)

Vendor performing sampling shall use Personal Protective equipment.

The Vendor must provide a cooler and ice packs or other effective methods to maintain the required temperature as required by contract requirements.

Transportation Requirements

The contractor is responsible for all transportation and/or shipping while performing under this contract.

Bacterial replication shall be prevented by holding the sample on ice (or through other means of keeping the sample between 1.0 °C- 4°C [39.2°F]) until it is delivered to the laboratory for testing.

The recommended maximum elapsed time between collection and analysis of sample is 8 h (maximum transit time 6 h, maximum processing time 2 h)

When analysis cannot begin within 8 h, maintain sample at a temperature for SPS, maximum elapsed time between collection and analysis must not exceed 24 h.

Any samples that arrive at the lab out of range shall be resampled within 24 hours of when the sample was taken.

Samples collected are transported immediately back to vendor laboratories and the endotoxin results are required to be provided to the VA within 48 hours

Samples collected are transported immediately back to vendor laboratories and the bacterial results are required to be provided to the VA within 72 hours

Samples collected are transported immediately back to vendor laboratories. Conductivity, alkalinity, pH, hardness, and ionic composition results are required to be provided to the VA within 5 days. The vendor shall include maintained temperatures in the sample collection result report.

Laboratory Requirements

The testing laboratory shall have qualified technical support staff for consultation relative to water sample collection, testing, and interpretation results.

The testing laboratory processing the water samples for ST-108 compliance with water quality must be certified by the Centers for Disease Control and Prevention (CDC) Environmental AAMI compliance

On Demand Retesting

Retesting is a critical part of the services required. Retesting shall be done within 48 hours of notification or on the next testing day, absent of Saturdays, Sundays or Federal Holidays. Retesting is required for the following:

After out-of-range values as defined in ST-108.

After system modifications. Per ST-108, the loop and associated point of use equipment/fixtures will be required to be retested in accordance with Appendix B . The VA Program Manager will specify when this retest is required. The VA cannot anticipate the total number of frequencies for this retest. This work will be performed under a separate Task which the vendor will provide a unit cost. It is estimated the minimum number of retests for this requirement is twice per month.

Reporting and Chain of Custody Requirements

All sample analysis reports shall be emailed to the VAMC designated Point of Contract(s) (POC(s) within, including weekends. Routine analytic reports shall include:

Name and signature of person collecting the sample

Date, time, pH, and temperature of sample when collected

Date, time, and temperature when sample arrived in Lab

Building number, room number, room name, area name, as defined in Attachment B

Date and time sample was plated/analyzed

Laboratory and person responsible for performing the analysis

Actual wet signatures or digital if electronic for transfer

Analytical technique/method used

The unique laboratory sample identification number/code for the accredited lab

Results of analysis

Vendor Qualifications

Water used for medical device processing must be within the appropriate standards for critical water as listed in AAMI/ANSI ST108 to the point-of-use.

International Organization of Standards (ISO) 9001, 14001

Vendor must be trained in best practices of sample collection, preservation, and must be able to perform on-site testing when necessary.

Vendor qualifications shall include EPA, CDC and ISO (17025) certifications.

Vendor must possess the ability to perform quality control procedures on reagents and supplies (for sterility and product efficacy), document equipment performance and maintain equipment to manufacturer recommendations as needed to maintain compliance with this Performance Work Statement (PWS).

Vendor shall supply all equipment to complete testing. Equipment may include but is not limited to the following:

Hach DR1900 and DR3900 Spectrophotometers

YSI Multi Lab 4010-W3

reactor/heat block, autoclave

pH meter

TDS meter

Colorimeter

Shaker

incubator

pipettors

Heterotrophic Plate Count SM9215

American National Standard Institute ANSI/AAMI ST108:2023

Clinical & Laboratory Standards Institute (CLSI) guidelines

Schedule

All work to install the equipment will be performed on a Saturday only. The installation is required to be performed in one day.

All maintenance and repair work will be performed Monday Friday at 5AM 7AM

All Water testing must be completed Monday Friday 7AM 11AM

Security Requirements

Vendor is required to have VA approved form of identifications to include a driver s license or photo ID, and Government PIV Contractor Identification card as it applies. ID badge must be always worn by Contractors while on VA premises

Will need to wear a mask while on the premises and be screened on the way in each day.

Contractor may not have access to the VA network or any VA sensitive information under this contract.

Contractor owned computer equipment including laptops are not permitted to be connected to the VA network

All Contractors must receive Privacy training annually using one of the following methods:

Complete VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information training by using VA s TMS system (https://www.tms.va.gov/SecureAuth35/).

Complete the hard copy version of VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information .

Signed training documents must be submitted to VA Point of contact for this contract.

Training must be completed prior to the performance of the contract and annually thereafter.

Task Orders

All worked performed under this contract shall only be performed by the contractor via Government issued task orders award against the base contract.

The Task Order will include the line items, quantities and associated pricing. All pricing shall be determined directly from the base contract Pricing Schedule.

Each Task Order will include

Initial equipment installation based on a 30-day tank exchange rate

Overage charge rate for additional DI water VA uses

Additional tank exchange due to 7.3.2

Maintenance fee

Water testing for ST-108 compliance per Attachment B

Additional water testing based on VA requests

Quarterly Sanitization of the DI Loop

Additional DI Loop sanitization due to VA request

Invoices will be paid upon satisfactory completion of all project-specific tasks, requirements, and acceptance. Individual purchase order numbers will be issued on each task order for invoicing purposes.

Exclusions

All Electrical work will be performed by VA

All Carpentry work will be performed by VA

Sink removals to provide clearance for the skid mounted DI system will performed by VA

Alterations to the existing DI water loop.