Attachment 1 Statement of Work for Critical Water Testing Services HT941026EQ0027.docx

STATEMENT OF WORK

This requirement is for Critical Water Testing services at Robert E. Bush Naval Hospital, Twentynine Palms, CA.

GENERAL REQUIREMENTS:

The effort required hereunder shall be performed in accordance with this Statement of Work and in accordance with all other terms and conditions set forth herein.

The Contractor shall provide all services, labor, parts, materials, and equipment necessary for the water sample of the Reverse Osmosis Tanks in Decontamination area of Sterile Processing Department (xl) and Main Operating Room (x2) at Navy Medicine Readiness and Training Command, Twentynine Palms, CA.

Contractor shall sample within the original equipment manufacturer's specifications, and in accordance with the US, State, and Local laws and regulations, US Navy regulations, American Association for Medical Instrumentation (AAMI) guidelines, and Joint Commission recommendations.

THE CONTRACTOR SHALL PERFORM THE FOLLOWING FUNCTIONS:

· Perform Monthly, Quarterly, Annual, and Emergency testing as required by AAMI TIR 34.

· Perform monthly samples to include: Chloride, pH, Bacteria, Conductivity.

· Use SM9215B Heterotrophic Spread Plate method for bacteria test with agar that allows for results after two (2) days of incubation.

· Perform Quarterly testing to include: Endotoxins, Total Organic Carbon (TOC), Total Dissolved Solids (TDS). Quarterly sample will be taken in conjunction with monthly sampling.

· Perform Annual samples to include: Hardness, and Ionic Contaminates.

· Per AAMI TIR 34, Analysis of a sample should be initiated as soon as possible after collection to minimize changes in the bacterial population. The recommended maximum elapsed time between collection and analysis is 8 hours. When analysis cannot begin within 8 hours, the sample should be maintained at a temperature of 2°C to 8°C (35.6°F to 46.4°F); in this case, the maximum elapsed time between collection and analysis should not exceed 24 hours.

· Contractor must be able to conduct Emergency samples when one of the criteria is met on the RO system that constitutes testing. Samples will be one sample of bacteria and endotoxin.

· If results constitute for re-testing, Contractor must be able to perform emergency re-testing the same day the results were provided.

· Emergency results must be reported within two (2) days (unless the incubation period ends on a weekend, in which case they will be received the following Monday) to mitigate the effects of out-of-acceptable-range endotoxin and bacteria levels on our surgical and sterilization.

· Contractor shall take samples from 3 designated ports identified by SPD staff.

· Contractor is responsible for samples and all cost associated with delivery, laboratory requirements, equipment, consumables, and reporting results back to POCs.

· Contractor shall schedule visits for sampling at least 2 days in advance with the Sterile Processing Department staff.

· Contractor will require escort by NMRTC Twentynine Palms SPD staff.

· Contractor will supply personnel and required items to collect water samples from NMRTC Twentynine Palms.

· Contractor shall provide an electronic copy of all results of all samples to all POCs identified within seven (7) days of testing, but will send results for bacteria and endotoxins as soon as they are available.

Please see below for AAMI TIR 34 Recommended levels of water quality for medical device reprocessing, overview of water quality monitoring and sample collection details.

\TYPE OF WATER

UTILITY WATER

CRITICAL WATER

WATER USE

FLUSHING/WASHING/ RINSING

FINAL RINSE/ STEAM

SPECIFICATIONS:

UNITS

CONDUCTIVITY

(MG/L=PPM)

PH

OVERVIEW OF WATER QUALITY MONITORING

analyzed by Suggested frequency of testing

Bacteria

Heterotrophic plate count Reprocessing area, storage tanks (if used), immediately downstream of water treatment process

Maintenance personnel

Monthly

Endotoxins

LAL test

Reprocessing area, storage tanks (if used), immediately downstream of water treatment process

Maintenance personnel On installation, modification, or repair of the Critical Water treatment system or when persistent increased microbial levels are detected by heterotrophic plate count, ATP, or

TOC

pH pH meter

Colorimetric dipsticks Reprocessing area

Reprocessing area -Maintenance personnel -Reprocessing personnel Monthly

Monthly

Colorimetric dipsticks

Reprocessing area -Reprocessing personnel Annually

Sample collection details per AAMI TIR 34

Samples of Critical Water (or other types of water when indicated) should be collected from several places to give an indication of the microbial quality of the water throughout the water distribution system. In general, samples should be collected at the beginning and end of the water distribution loop, where water enters equipment used to reprocess medical instruments. If a storage tank is used, water should be sampled at the end of the water purification cascade and where water exits the storage tank.

Samples should always be collected before sanitization or disinfection of the water treatment system. If repeat cultures are performed after the system has been disinfected (e.g., with hydrogen peroxide, chlorine, or peracetic acid), the system should be flushed completely before samples are collected. Before samples are collected, the storage tanks and distribution system should be drained and flushed until residual disinfectant is no longer detected. For new systems, the water should be cultured weekly until an established pattern has been determined. For established systems, the water can be cultured monthly (or at least quarterly) unless a greater frequency is dictated by historical data at a given institution.

Water samples should be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps should be opened and the water allowed to run for at least 60 seconds before a sample is aseptically collected in a sterile, endotoxin-free container. The collection container should not be made of polypropylene, because polypropylene has been shown to inhibit endotoxin detection (Roslansky, et al., 1991). At least 100 to 300 mL of water should be collected. Sample taps should not be treated with disinfectants. If treatment of taps is desired, alcohol should be used. The sample should not be collected until all the alcohol has evaporated so that no disinfectant residual will be left in the sample. Bleach or other disinfectant solutions should never be used.

Bacterial replication is prevented by holding the sample on ice (or at 4°C [39.2°F]) until it is delivered to the laboratory for testing.

Combinations of incubation media, time, and temperature other than those recommended could occasionally-or even consistently-result in higher numbers of cfus being observed.

TITLE TO EQUIPMENT: The contractor shall use only equipment which they own in carrying out service for this contract.

LIABILITY: The contractor shall not be liable for any loss, damage, or delay due to any cause beyond his reasonable control including but not limited to, acts of government, strikes, lockouts, fire, explosion, theft, floods, riot, civil commotion, war, malicious mischief or acts of God.

UTILITIES: The contractor may use Government utilities, (e.g., electrical power, compressed air, and water) that are available and required for any service performed under this contract.

CONTRACTOR CHECK-IN/CHECK-OUT: The Contractor, or his representative, is required. to check-in and out at the NMRTC Twentynine Palms Quarterdeck during the hours of 0730 - 1600 hours, Monday through Friday, prior to and upon completion of any service performed.

FIELD SERVICE REPORTS: The contractor or his representative shall furnish to:

Main Operating Room Staff and Infection Prevention:

A legible copy of the Field Service Report upon completion of work performed. The contractor, or his representative, shall complete the Government copy of this Field Service Report to include the following:

· Date and Time Notified

· Date and Time Arrival

· Set and or equipment names and quantities

· Time expended sampling

· General Description of samples performed

FIELD SERVIC E REPORTS ARE REQUIRED PRJOR TO AP PROVAL OF ALL INVOICES

GOVERNMENT PERSONNEL: NMRTC MOR employees will provide escort from quarterdeck to sample sites.

Labor: All compensation for labor is included in the contract price.

Parts and materials: Compensation for only the parts and materials listed is included in contract price.

Parts/Supplies Quality: Parts and Supplies provided under this contract shall be guaranteed to be equal in all respects, including performance, interchangeability, durability and quality to the OEM parts when new or as presently recommended by the manufacturer.

(End of Statement of Work)