Reverse Osmosis Statement of Work _6.21.24.pdf

Reverse Osmosis 06/21/2024

1. Introduction: The 88th Medical Group (MDG) at Wright Patterson Medical Center (WPMC) requires a new reverse osmosis system to replace the current unit. On September 8, it was noted that the system is degrading and has expected remaining life expectancy of 6 months. If this system goes down, MDG will lose 100% instrument reprocessing capability at the Medical Treatment Facility (MTF). Reverse osmosis provides de-ionized water for the washers that clean WPMC surgical instruments. This cannot be substituted by any other type of water.

2. Background: Deionized (DI) water is water that has had all the ions removed. Ions are charged particles, meaning that they have a positive or negative electrical charge. Many of the impurities in water are dissolved salts, a type of ion. When water is passed through the DI system, the ions are easily removed, leaving clean, pure water. This water is necessary for surgical instruments to go through the washer. The washer decontaminates the instruments making them safe for handling so that they can be assembled or use. On average the sterilization department will process 90-120 instruments a day which is determined by the number of surgeries scheduled as well as the type of procedure.

Additionally utilizing pure -or- deionized water is essential to the longevity of the facility’s sterilization equipment.

3. Period of Performance:

o Timeline of completion for removal of existing system, product delivery, and installation: within 30 days of contract award.

o Base Access Point of Contact:

• SrA Jaslyn Gutierrez, 937-257-8866 , Jaslyn.s.gutierrez.mil@health.mil

• SrA Jeffrey Allen, 937-713-2550, jeffrey.w.allen58.mil@health.mil

• TSgt Dwayne Wheatley, 937-713-3952, dwayne.h.wheatley.mil@health.mil o Surgical procedure dates – N/A o Is hand delivery by sales representative required: No o Does sales representative need to be present during surgery: No

4. Building address: 4881 Sugar Maple Dr Bldg. 830, Wright Patterson AFB, OH, 45433

5. Minimum Requirements:

o Size – The Central Sterile department has determined that they will need a 185 Gallon tank to support the amount of water output that will be needed for continued operations.

STATEMENT OF WORK

mailto:jeffrey.w.allen58.mil@health.mil mailto:dwayne.h.wheatley.mil@health.mil o Design – Tempered tap water from the blend valve enters the water system first through the carbon filters to remove chlorine, after which a chemical injection system injects anti-scalant into the Reverse Osmosis (RO) feed water stream to control hardness scaling. The RO unit removes > 96% of the dissolved impurities from the tap water. The RO concentrated waste is sent to the drain. RO product water flows through the mixed bed deionizer then to the storage tank. DI water quality is monitored with an audible 1 megohm quality indicator. Water from the storage tank is re-pressurized by a distribution pump and sent to the UV disinfection unit followed by a bacteria/endotoxin final filter. From the final filter water is continuously recirculated to the usage points throughout the sterile processing department. Water from the continuously flowing distribution loop is recirculated back to the storage tank and monitored and controlled by a return flow meter, pressure gauge and relief valve. The entire water system is monitored by a central alarm panel with a remote alarm.

Performance Requirements –

• The RO system shall provide a minimum flow rate of at least 70 gallons per minute (GPM) to meet the demand of the washers.

• The RO system shall produce clean, purified water by removing contaminants and impurities, making it suitable for various applications, including drinking water and, industrial processes.

• Shall meet the following ANSI/AAMI (American National Standards Institute/Association for the Advancement of Medical Instrumentation requirements and provide the below requirements for successful operation and lifecycle management of sterilizers and washers currently in the sterilization department:

o Ultrasonic Irrigator Shall support 4 units within the sterilization department of

WPMC.

Water Hardness, Quality, & Purity Conductivity: <125ppm with water quality and purity tested and approved for Disinfection as per ANSI/AAMI ST 15883-1:2009 (item 6.4.1 and 6.4.2) or AAMI TIR 34 <30μS/cm (RO) <10μS/cm (DI) <300μS/cm (Soft)

Pressure: 30 – 70 psi for all water supplies Flow Rate: 3-8 US gal/m Temperature:

• Cold Water 41 – 86°F

• Hot Water 122 – 140°F

• RO Water 41 – 140°F

Water Consumption:

• Total Per supply:

o Cold 11US gal o Hot 11US gal o RO 10US gal

• Total Cycle 32US gal o Cart and Utensil Washer-Disinfector Shall support 1 unit within the sterilization department of

WPMC.

Hot Water Requirements:

• Pressure Range - 15 - 50 psig DYNAMIC [103-345 kPa] MAX. 90 psig STATIC [620 kPa]

• Operating Flow Rate - 19 US GPM [72 L/min] AT 15 psig [103 kPa] TO 35 US GPM [132 L/min] AT 50 psig [345 kPa]

• Total Consumption for Standard Cycle - FIRST

CYCLE: 50 US GAL [189 L] (25 US GAL [95 L] PER

PHASE) CONSECUTIVE CYCLES: 14 US GAL [53

L] (7 US GAL [27 L] PER PHASE)

• Temperature Range - 110°F [43°C] TO 150°F [65.5°C] Water Quality - HARDNESS (CaCO3) : 50-80 ppm (MAX. 120 ppm)

Cold Water Requirements

• Pressure Range - 30 - 50 psig DYNAMIC [206-345 kPa] MAX. 90 psig STATIC [620 kPa]

• Operating Flow Rate - 30 US GPM [114 L/min] AT 30 psig [206 kPa] TO 38.5 US GPM [146 L/min] AT 50 psig [345 kPa]

• Total Consumption for Standard Cycle - FIRST

CYCLE: 0 US GAL [0 L] CONSECUTIVE CYCLES:

0 US GAL [0 L]

• Total Consumption for Drain Cooling - IF

RECYCLING: 7 US GAL [26] NOT RECYCLING: 46

US GAL [175 L]

• Temperature Range - 40 - 70°F [4.4 - 21°C]

MAXIMUM

• Water Quality Hardness - (CaCO3): 50-80 ppm (MAX.

120 ppm)

Pure Water Requirements

• Connection Size/Type - 3/4 in / FEMALE NPT 3/4 in /

MALE BSPT

• Pressure Range - 5 - 50 psig DYNAMIC [34 - 340 kPa]

MAX. 90 psig STATIC [620 kPA]

• Operating Flow Rate - 12 US GPM [45 L/min] AT 5 psig [34 kPa] TO 28 US GPM [106 L/min] AT 50 psig [345 kPa]

• Total Consumption for Standard Cycle - FIRST

CYCLE: 0 US GAL [0 L] CONSECUTIVE CYCLES:

0 US GAL [0 L]

• Temperature Range - 150°F [65.5°C] MAXIMUM

• Resistivity (Conductivity) 0.5-0.1 MΩ -cm [2-10 µS/cm]

• pH 6.8 - 7.5 o Single Chamber Washer-Disinfector (Steam Heated)

Shall support 4 units within the sterilization department of

WPMC.

Manufacturer Recommended Water Quality Parameters:

• Total Dissolved Solids: 100-200 ppm (MAX 500 ppm)

• Total Alkalinity (CaCO3): 70-120 ppm (MAX 180ppm)

• pH: 6.8-7 (MAX 7.5)

• Total Silica: 0.1-0.5 ppm (MAX 1ppm)

Hot Water Requirements:

• Pressure Range - 15 - 50 psig DYNAMIC [103-345 kPa] MAX. 90 psig STATIC [620 kPA]

• Operating Flow Rate - 6.8 US GPM [25.7 L/min] TO

14.1 US GPM [53.4 L/min]

• Total Consumption Per Instrument Cycle - 9.9 US GAL

[37.5 L] WITH ACU-WASH RESERVOIR:6.6 US

GAL [25.0 L]

• Temperature Range - 110 °F [43 °C] TO 150 °F [65.5 °C]

• Water Quality - HARDNESS (CaCO3): 50-80 ppm (MAX. 120 ppm)

Cold Water Requirements

• Pressure Range - 30 - 50 psig DYNAMIC [206-345 kPa] MAX. 90 psig STATIC [620 kPa]

• Operating Flow Rate - 10.7 US GPM [40.5 L/min] TO

14.1 US GPM [53.4 L/min]

• Total Consumption Per Instrument Cycle – FOR SUMP

FILLING: 10.5 US GAL [39.8 L] (ADD THE

FOLLOWING CONSUMPTION FOR

OPTIONS/CONFIGURATIONS)

o CONDENSATE RETURN COOL DOWN: 6.2

US GAL [23.5 L]

o NON-VENTED SYSTEM: 12.9 US GAL [48.8 L] o DRAIN COOLDOWN: 14.5 US GAL [54.9 L] o DRAIN ACU-COOLDOWN: 10.9 US GAL

[41.3 L]

• Temperature Range - 70 °F [21 °C] MAXIMUM

• Water Quality - HARDNESS (CaCO3) : 50-80 ppm

MAX. 120 ppm) Pure Water Requirements

• Connection Size/Type - 1/2 in / FEMALE NPT [1/2 in /

MALE SPT]

• Pressure Range - 5 - 30 psig DYNAMIC [30 - 206 kPa] MAX. 90 psig STATIC [620 kPa]

• Operating Flow Rate - 5.5 US GPM [21 L/min] TO

12.6 US GPM [48 L/min]

• Total Consumption Per Instrument Cycle - 6.6 US GAL [25.0 L]

• Temperature Range - 70 °F [21.1 °C] TO 150 °F [65.5 °C]

• Resistivity (Conductivity) - 0.1-0.5 MΩ -cm (2-10 μS/cm)

• pH - 6.8 - 7.5 o Maintenance Plan – The contractor shall provide maintenance of the water purification system to include the Reverse Osmosis System being requested. After the one year initial award of this contract, the maintenance plan will be an annual agreement with 4 option years.

Description of Services: The contractor shall provide the required support to ensure the operational integrity of the equipment. The contractor shall provide all supplies, services, equipment, and transportation as well as obtain necessary documentation (i.e. repair manuals, technical orders, parts catalogues, and drawings), needed to restore and keep the water purification equipment in operating condition. The maintenance plan shall include labor, parts, and other requirements as necessary to maintain the equipment in good operating condition. The contractor shall not be liable for repairs necessitated by catastrophic accident; neglect; misuse;

failure of electrical power, air- conditioning, or humidity control, unless caused by the contractor, or fault of; negligence of; or movement by the government.

Service Requirements:

• The contractor shall use only new original equipment manufacturer (OEM) parts or new parts of equal performance that the manufacturer deems necessary as replacement parts in effecting repair. All parts shall have no less than a 90-day warranty period

• The contractor shall maintain the water purification systems within operational parameters in accordance with Association for the Advancement of Medical Instrumentation (AAMI) Standards. 0.2 sub-micron filtration is utilized, as well as water recirculation to minimize bacterial growth within AAMI Standards.

• The contractor shall provide sanitization of Reverse Osmosis (RO) membranes annually and a monthly treatment to disinfect the loop.

• The contractor shall complete two-(2) product water trace elemental analyses per year for routine monitoring of the quality of water produced by the system.

• The contractor shall monitor the system via audible alarm to detect malfunctioning status of water system as well as monitoring alarms.

• The contractor shallprovide preventative sanitation monthly. Preventative sanitation includes sanitation of the storage tank and distribution piping including freshwater rinse after the sanitation.

• The contractor shall be responsible for all maintenance on the system, changing filters, flushing, system disinfection, routine and non-routine maintenance and shall use infection control procedures to prevent cross-contamination.

o Installation & Testing – The vendor chosen shall complete deinstallation of the current system prior to installation of the new system. The vendor shall ensure that the new system is fully operational and that there are no leaks/problems prior to departure.

o Warranty –The Reverse Osmosis System shall come with a one-year warranty to include the replacement of new parts.

o Standards, guidelines or approvals –System shall conform with the recommendations put forth by the Association for Advancement of Medical Instrumentation (AAMI). These recommendations are divided into two segments for medical device reprocessing: utility water and critical water. This product shall provide critical water for washers, disinfectors, glassware washers, steam boilers and final rinses.

ANSI/AAMI ST79: 2017 recommends to "rinse with water of the quality specified by the device manufacturer. When the water quality is not specified by the device manufacturer, refer to AAMI TIR34". (Reference ANSI/AAMI ST79: 2017, Section 7.4.1 j)

AAMI TIR 34 states that "if the quality of the tap water could cause corrosion, tarnishing, or salt deposits, it might be necessary to use various water treatment processes (e.g., softening, deionization) to ensure that devices are not damaged and that the ensuing disinfection or sterilization process will be effective".(Reference AAMI TIR34: 2014/(R)2017, Section 5.2.1.3)

"For devices that will contact the bloodstream, or other sterile areas of the body, the final stage in rinsing requires water that does not have excessive levels of organics (e.g., endotoxins or other microbial constituents);

therefore, Critical Water is recommended in the final rinsing stage before sterilization". (Reference AAMI TIR34: 2014/(R)2017, Section 5.2.1.3 )

Critical Water is water that meets certain quality specifications and may need to be "extensively treated (usually by a multistep treatment process that could include a carbon bed, softening, DI and RO or distillation) to ensure that the microorganisms and the inorganic and organic material are removed from the water. This water is mainly used for final rinse of critical and semi-critical devices. (Reference AAMI TIR34:2014/(R)2017, Section 4.2 b)