SOW CAVHS SPS Steam Quality Testing.docx

STATEMENT OF WORK

Steam Quality Testing and Port Installation Central Arkansas Veterans Healthcare System (CAVHS)

1. SCOPE

1.1. The contractor will complete work for this service contract per the provided attachments, specifications, and this SOW. The qualified Contractor shall furnish all labor, materials, tools, equipment, transportation, and qualified supervision necessary to provide steam quality testing at the Central Arkansas Veterans Healthcare System (CAVHS) 4300 West 7th Street Little Rock AR 72005 steam sterilizers in room GE-107 to determine compliance with ANSI/AAMI-ST79 and ANSI/AAMIST108. All critical variables under these requirements shall be tested. The testing shall also include moisture content (saturation), physical inspection, and condensate parameters (alkalinity, conductivity, pH, etc.). The Contractor shall provide all resources and labor for the sample collection, testing, and reporting, and shall be appropriately qualified to perform these required tests. VA personnel will be available for access and some rudimentary assistance, but the contractor will be primary with regards to conducting the testing and reporting. Access to the space where the test will be located shall be coordinated with the COR. Results shall be presented in a neat and orderly fashion with sample sets and results clearly delineated. Final reporting of results shall occur within two weeks (14 days) of completion of the testing. If a new port must be installed to allow for sterile and safe testing to occur, any new pipe or fittings must fall within the VA’s allowable materials. Cast iron, black iron, etc. shall not be installed. Materials such as cast steel or forged steel may be used. Confirm materials are approved with the COR before conducting work. Work must be in accordance with applicable local, state, and federal codes, rules, and regulations. Impact shall be minimized and mitigated in a way that limits disruption to the functioning of the Medical Center. If any damages occur during installation, it will be the responsibility of the contractor to bear the costs for repairs. Scheduling and coordination with the CAVHS will be critical and must be approved by COR prior to work.

1.2. Delivery of detailed work proposal to COR prior to starting work.

1.3. Steam Audit - Sterilizer(s) Wet Pack Troubleshooting Steam Quality Test as described in ANSI/AAMI ST79 -"Comprehensive guide to steam sterilization and sterility assurance in health care facilities".

1.4. Conduct steam quality and purity testing at access point in accordance with ANSI/AAMI ST108 and ANSI/AAMI ST79.

1.5. Steam quality testing to include dryness of steam, level of non-condensable gases (NCGs), superheat of steam.

1.6. Steam purity testing to include pH, conductivity, total alkalinity, and total hardness.

1.7. Delivery of testing results in report format via email.

2. GENERAL GUIDANCE

2.1. Employees of the contractor and sub-contractors shall always conduct themselves in a professional manner while on medical center property. The contractor shall ensure all personnel working on this contract are aware of Medical Center rules pertaining to employee behavior and conduct.

2.2. Physical or verbal misconduct may be grounds for removing employees from Medical Center property, or grounds for arrest by the VA Police. Employees may be banned from Medical Center property as a result of inappropriate or illegal behavior. The contractor shall not be entitled to any compensation from the Government for any costs resulting from employee misconduct (including, but not limited to, delays in contract completion) and may be held liable for costs incurred by the Government as a result of employee misconduct.

2.3. Tobacco Use is 100% prohibited on all VA property.

2.4. The VA will not be responsible for storage of equipment, materials, or tools.

2.5. It is the contractor’s responsibility to properly assess the working conditions and include in the bid any specialty equipment, training, additional time, personnel, or safety equipment to perform the work safely and in compliance with all applicable local, State, and Federal regulations.

3. Hours of Work

3.1. Normal working hours are 0700 – 1700 Monday to Friday, except for federal holidays. Preparation can be done during these hours. To reduce patient impact, all work that requires a utility outage will need to take place during afterhours (1700 – 0500) or during weekends. All work started shall be completed and the work area(s) ready for full operations no later than 0500 the following day, unless otherwise coordinated with the COR. All schedules and work hours shall be requested, coordinated, and approved through the COR.

3.2. The contractor can phase the work such that it is most efficient for their work schedule. The planned phasing and schedule will be provided to the Government as part of the bid package. Finalized phasing and schedule will be subject to Government approval and will be provided to the Government within 3 calendar days of kickoff meeting.

4. Infection Control

4.1. Employee clothing and shoes shall be cleaned of all dirt and debris before entering the medical center, and before leaving the work site. Employees shall wear closed toed shoes, long pants, and shirts that always cover the shoulders and upper arms while in the medical center.

5. GOVERNMENT RESPONSIBILITIES

The government will provide the contractor access to the rooms CAVHS Little Rock room GE-107 for insulation and EJTVAHC North Little Rock Building 170 room GK-126.

6. CONTRACTOR REQUIREMENTS

6.1. The contractor will provide onsite installation at CAVHA ground floor room GE-107, and EJTVAHC North Little Rock Building 170 room GK-126 support and inspection of system startup, system sanitization, customer training and verification sampling. Equipment unloading, moving, and rigging into position and anchoring. Equipment and instrumentation quality assurance checks onsite for initial setup. Interconnecting piping between equipment skids and ship loose components. Field testing of unit assemblies and system startup.

7. SECURITY REQUIREMENTS

7.1. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

7.1.1. The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

7.1.2. The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

8. Safety

8.1. Prior to commencing work, general contractor shall provide proof that an OSHA certified “competent person” (CP) (29 CFR 1926.20(b)(2) will supervise all work under this contract and maintain a continual presence at the work site whenever the general or subcontractors are present. In accordance with FAR 52.236-6, at all times during performance of this contract and until the work is completed and accepted, the Contractor shall directly superintend the work or assign and have on the worksite a competent superintendent who is satisfactory to the Contracting Officer and has authority to act for the Contractor. Assigned CP shall have completed the OSHA 30-hour construction safety training within the past 5 years and all other construction workers shall have at least a 10-hour OSHA course. Whenever executing work within the proximity of live electrical equipment (including testing, voltage/current measurements, infrared scans, ultrasonic scans, and/or verifying a de-energized condition prior to performing work), the contractors shall provide and wear full and proper Personal Protective Equipment per the requirements of VHA Directive 1028, NFPA 70E. The contractor must also provide all lockout/tagout equipment required to secure electrical safe work conditions.

9. References

9.1. Contractors shall have ready access to the latest versions of the following references:

9.1.1. Latest editions of ANSI/AAMI ST108 Water for the processing of medical devices.

9.1.2. Latest edition of ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities

10. Schedules

10.1. The contractor must work with the COR to schedule all work. Work must be completed within 60 calendar days of the contract award.

11. Parking/Laydown Area

11.1. The Contractor shall make arrangements for parking. At no time shall vehicles be parked on roadways, patient parking areas, the loading dock, etc. Coordinate use of the loading dock for loading/unloading material with the COR. Materials shall not be deposited on the loading dock for any length of time.

11.2. There is no guarantee for laydown of testing equipment. The CAVHS shall not provide an extensive area for storage of testing equipment. Again, scheduling and coordination with the CAVHS will be critical. Interim Life Safety Measure (ILSM) Permit may be required for staged testing equipment due to increased combustible loading. It is the responsibility of the Contractor to ensure their testing equipment remain secure.

12. Utility Shutdowns

12.1. The Contractor must coordinate and request a shutdown with the VA prior to shutting down or interrupting any utility system. The Contractor shall provide a minimum of 21 calendar days of notice for a utility shutdown. The Contractor shall make every effort possible to reduce the amount and duration of impacts of utility shutdowns. Requests to shutdown utilities are dependent upon the Medical Center’s ability to maintain normal operations. Should a request be denied due to clinical needs, the COR shall inform the contractor of alternate dates and times that meet the Medical Center’s needs. Before initiating any work or portion thereof, a specific work plan, which is to include procedures to be used on and near the energized electrical equipment, barriers to be installed, safety equipment to be provided and exit paths identified shall be developed. This plan shall be review by CAVHS staff and documented.

13. Period of Performance

13.1. Period of Performance is 60 calendar days from the Notice to Proceed.

13.2. Contractor shall have an accepted schedule prior to start of work, but hospital operations shall take priority. Contractor may have to shift areas of work around to accommodate hospital operations.

14. Specification

14.1. ANSI/AAMI ST 79 Annex L

Annex L (informative) Steam quality L.1 Introduction This Annex provides guidelines on how to achieve and maintain adequate steam quality for steam sterilization processes. L.2 General considerations As recommended in 3.3.3 of the main text, steam systems should be designed to ensure that a continuous and adequate supply of saturated steam is available to the sterilizer. The critical variables are the dryness of the steam, expressed as a dryness fraction, and the level of noncondensable gas (such as air), expressed as a fraction by volume. Steam dryness should be at a value between 97% and 100%, and the level of noncondensable gas should be at a level at which it will not impair steam penetration into sterilization loads. Steam pipework should be insulated, and it should be designed so that any condensate flows by gravity in the same direction as the steam, except for vertical rises between floors. This general principle applies equally to steam mains, branch connections, and pipework on the sterilizer itself, especially in situations where the steam is generated in a location remotely located from the sterilizer. Air vents and steam traps should be fitted at each vertical rise. Care should be taken to trap, drain, and return any condensate that could be collected in pockets in the pipework. Dead legs should be avoided. (A “dead leg” is a section of pipe that leads nowhere and does not form part of a constant circulation system; in a steam line, condensate can form in a dead leg and become stagnant.) Branch steam lines should exist from the top of the main lines to reduce condensate carryover. The accumulation of condensate during the periods when the sterilizer is not in operation should be avoided, particularly in any part of the pipework and fittings between the take-off from the manifold and the sterilizer chamber. This can be achieved by the correct declination of each portion of pipework and by adequate trapping throughout the steam distribution system. At installation, an assessment of the steam quality should be made and documented. Steam quality should be maintained by monitoring and controlling the process of generating steam; maintaining steam traps, boilers, and generators in good working order; and periodically assessing sterilization loads for wet packs. In some circumstances, a steam separator may be used to remove entrained water and increase the degree of steam saturation. If used, the separator should be placed in the steam supply piping as close as possible to the sterilizer. L.3 Steam dryness The dryness of the steam is of vital importance to the performance of any steam sterilizer. Excess moisture can cause damp loads in porous materials and uneven temperature distribution in nonporous materials, particularly those containing a large number of small items. Sterilizing conditions might not be attained if the moisture contained in the steam supply is insufficient to prevent the steam from becoming superheated when it expands into the chamber. Significant deviations in steam dryness are likely to cause the following problems: a) Wet loads, resulting from a dryness value that is too low b) Superheating, resulting from either a dryness value that is too high before the pressure-reducing system or from excessive pressure reduction through the valve (superheating can be severe if both conditions are present simultaneously) c) Difficulties with operation of the pressure-reducing system, resulting from a low pressure-reduction ratio, water hammer, water logging, and/or dirt and other carryover. If wet steam continues to be a problem, “priming” could be occurring in the boiler, causing water droplets to be delivered in the steam. Modern compact, high-rated boilers and steam generators are particularly sensitive to the quality of feedwater and are much more likely to prime than boilers of traditional design. Priming or foaming (which results in carryover of boiler water) can result from d) treating feedwater incorrectly; e) setting the boiler water level too high;

f) forcing a boiler that needs internal cleaning; g) violent boiling under fluctuating load conditions; and/or h) a high level of total dissolved solids (typically 2,000 ppm). Superheated steam is an unsuitable medium for steam sterilization and can cause failure to sterilize, scorching of textiles and paper, and rapid deterioration of rubber. Superheat conditions within the load and chamber could result from adiabatic expansion, exothermic reaction, or both. Superheating caused by adiabatic expansion (high-pressure steam entering a low-pressure chamber) is usually the result of an excessive reduction in pressure through a throttling device, such as a pressure-reducing system or a partially closed main steam valve. It is unlikely to be of significance in the circumstances normally encountered in hospital steam distribution systems, but superheating can arise if the main steam supply is dry or the pressure is unusually high before the throttling device. Superheating arising from exothermic reaction (rise in temperature from absorption of moisture) can occur during sterilization as a result of rehydration of exceptionally dry hygroscopic material. L.4 Noncondensable gases Noncondensable gases (NCGs) are defined as gases that cannot be liquefied by compression under the conditions of temperature and pressure used during the sterilization process. They can be simplistically described as air in a steam supply. Low levels of NCGs contained in steam supplied to sterilizers can markedly affect the performance of the sterilizer and the efficacy of the process and lead to inconsistencies in the performance of the sterilizer and in BowieDick test results. The main source of NCGs in the steam supply is the boiler feedwater, and the level will be greatly influenced by the water treatment used. In some cases, a study by a water-treatment specialist will be necessary. The study should cover analysis of the water, the venting characteristics, and the blow-down regime required to ensure protection of the boiler against corrosion while minimizing the entrainment of NCGs in the steam supply. If anti-foaming agents and oxygen-scavenging agents (such as sodium sulfite) are used, it is essential to ensure that the dosages are accurate. Water-softening treatment is required to prevent the formation of scale. Except in hard-water areas, a simple baseexchange system, in which bicarbonate ions are effectively converted into sludge-forming carbonates, is usually adequate. This process releases carbon dioxide into the water. A properly managed blow-down regime is essential to remove the accumulated sludge. The most effective way of driving off dissolved air, carbon dioxide, and other NCGs is to degas the boiler feedwater before use by heating it in a vented tank (a hot well). This process will also break down bicarbonate ions, driving off more carbon dioxide. For the degassing to be effective, it is important that the temperature of the feedwater remain high.

14.2. ANSI/AAMI ST108 Table 2 - Categories and performance qualification levels of water quality for medical device processing

14.3. ANSI/AAMI ST108 Table 4 – Water quality monitoring requirements

14.4. ANSI/AAMI ST108 Table 6 – Frequency for water quality monitoring at point-of-use.

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