DRAFT SOW.docx

Corporal Michael J Crescenz Veterans Affair Medical Center (CMCMC) 3900 Woodland Ave Philadelphia, PA 19104

Statement of Work for Preventative Maintenance on the Deionized Water System in Sterile Processing Service and Reverse Osmosis Dialysis Unit Department

1.0 General

The Corporal Michael J Crescenz Veterans Affair Medical Center (CMCMC) requires a five-year contract for Preventative Maintenance of the Deionized (DI) Water Equipment Systems. The DI Water Equipment Systems are essential for serving the Sterile Processing Services (SPS) and Dialysis Unit with critical water as required by Association of the Advancement of Medical Instrumentation (AAMI). This requirement sets standards for the critical water being used in the processing of instruments and equipment used in direct patient care. For SPS functions, poor water quality increases bioburden on the medical devices/instruments used in surgery. This causes premature breakdown of costly surgical instruments and high risk for surgical infections in post-operative veterans.

1.1 The contractor shall furnish all necessary labor, materials, parts, supervision, management, management support, transportation, supplies, and equipment necessary to furnish the services listed below.

1.2 The preventative maintenance services consist of evaluating system components, replacing consumable system components, generating Field Service Reports, and recommending corrective actions for deficiencies. The Preventive Maintenance Service shall consist of weekly, bi-weekly, and monthly site visits to meet scheduled maintenance intervals defined below.

2.0 Objective:

Services provided in this contract shall conform to original equipment manufacturer (OEM) maintenance and operation instructions, AAMI Standard 79, AAMI TIR 34:2014 and AAMI ST108-2023 recommendations for the water quality necessary for the reprocessing of medical instruments, and all other applicable AAMI Standards.

3.0 Scope:

3.1 Sterile Processing Service – Deionized Water System Preventative Maintenance and Sanitization

3.1.1 Every 7 days

3.1.1.1 Service exchange of (4) 3.6 cf Mixed Bed ion exchange resin tanks (DI) Tanks

3.1.1.2 Service exchange of (1) 3.6 cf carbon media (DI) Tank

3.1.1.3 Service exchange of (1) Filter cartridges 20” 1UM CDE F ROGII

3.1.1.4 Service exchange of (1) 5.0 micron 20’ Prefilter Cartridge

3.1.1.5 Check the Ultraviolet light system is operational.

3.1.2 Bi-Weekly

3.1.2.1 Perform Loop Sanitizing - of the DI piping system that support (5) DI sinks, (1) Cart washer, and (3) sterilizers.

3.1.2.2 Work is defined below and must be completed the 2nd Friday and last Friday of each month commencing @ 5AM. This time is required to eliminate the risk of impacting operations of SPS.

A. Disconnect existing DI beds and drain water in remaining line B. Remove pre/post filters C. Fill pre/post filter housings with biocide D. Purge all sample ports and points of use until sanitant can be detected to the level of a 1% solution (minimum of ten seconds per purge) E. Isolate loops to stand full for a minimum of one hour F. Install new DI beds G. Drain sanitant from loop H. Install new post filters I. Flush the loop with deionized water: Start recirculation pump, run the system to drain through all point-of-use valves and sample ports. Continue flushing until sanitant is removed.

J. Verify sanitant is removed by testing. Sanitant levels should be less than 2 ppm peracetic acid or equivalent.

K. Allow system to recirculate to normal quality and return to service.

3.1.2.3 Inspect the final filter for DI loop

A. The pre and post gauges will provide the pressure differentia is less than 15 psi. Verify that the pressure differential is less than 15 psi.

B. Immediately notify the point of contact if this UV filter is out of compliance.

3.1.2.4 After inline Endotoxin Filter Installation - Bi-weekly sanitization of the DI piping system will change after the installation of the endotoxin filter. This notification will come from the main point of contact. Please see section 3.1.3, on changes which will happen after endotoxin installation. Please see 3.1.3.2 (N), on how to remove, and install new filter after biocide treatment of the DI Loop sanitization.

3.1.3 Monthly

3.1.3.1 Perform Loop Sanitizing - of the DI piping system that support (5) DI sinks, (1) Cart washer, and (3) sterilizers.

3.1.3.2 Work is defined below and must be completed on the last Friday of each month commencing @ 5AM. This time is required to eliminate the risk of impacting operations of SPS.

A. Disconnect existing DI beds and drain water in remaining line B. Remove pre/post filters C. NEPHROS HydroGuard 10” UltraFilter, Part Number 70-0111

i. Turn off the water source upstream of the filter and vent any excess pressure from the housing via its bleed valve or outlet test valve

ii. Remove both the housing bowl/cover and old filter

iii. Open a new HydroGuard 10” Ultrafilter blister pack and aseptically remove the filter

iv. Insert the new O-ring end of the filter into the head of the housing. It may be necessary to use a twisting motion to ensure that the filter is firmly in place and the O-ring seat properly. Re-attach housing bowl/cover

v. Open the upstream water source and prime the new filter by opening the outlet test valve for a few minutes to purge it of trapped air (if the housing has a bleed valve, open it at the same time to assist purging)

vi. Close the outlet test valve (and bleed valves if present) and verify there are no leaks.

A. Fill pre/post filter housings with biocide B. Purge all sample ports and points of use until sanitant can be detected to the level of a 1% solution (minimum of ten seconds per purge) C. Isolate loops to stand full for a minimum of one hour D. Install new DI beds E. Drain sanitant from loop F. Install new post filters G. Flush the loop with deionized water: Start recirculation pump, run the system to drain through all point-of-use valves and sample ports. Continue flushing until sanitant is removed.

H. Verify sanitant is removed by testing. Sanitant levels should be less than 2 ppm peracetic acid or equivalent.

I. Allow system to recirculate to normal quality and return to service

3.1.3.3 Inspect the final filter for DI loop

A. The pre and post gauges will provide the pressure differentia is less than 15 psi. Verify that the pressure differential is less than 15 psi.

B. Immediately notify the point of contacts if this UV filter is out of compliance.

3.1.4 Quarterly

3.1.4.1 Change the final filter 0.2 micron for the DI loop

3.1.5 Every 6 months

3.1.5.1 Replace Ultraviolet lamp and associated component to ensure this system is operational.

3.1.5.2 Clean the UV sleeve: The UV lamp's protective sleeve collects debris over time, so it should be cleaned regularly. The UV sterilizer bulb itself should not be cleaned.

3.1.5.3 Check the o-rings and seals: Monitor the o-rings and seals for leaks.

3.1.5.4 Follow the manufacturer's guidelines: Different UV units may have slightly different maintenance requirements, so refer to the manufacturer's guidelines.

3.2 Dialysis Unit – Water Softener System - Preventative Maintenance

3.2.1 Monthly

3.2.1.1 Change the final filter 5 micron for the Dialysis Loop

3.2.1.2 Verify the water softener is operational per manufacturers specifications

3.2.2 Monthly

3.2.2.1 Cleaning all valves to prevent sediment and debris from accumulating

3.2.2.2 Ensuring the bypass valve operates smoothly allows easy system maintenance without disrupting the water supply.

3.2.2.3 Check all seals and spacers for damage. Replacing seals and spacers that show signs of wear prevents leaks and maintains the system’s structural integrity

3.2.3 Triannual – 3 Times per year

3.2.3.1 Replace Water softener resin tanks per manufacturer’s’ specification

4.0 Reporting:

4.1 The Contractor shall complete a maintenance chart adjacent to all equipment being serviced with the following:

4.1.1 Name of equipment

4.1.2 Date equipment was serviced.

4.1.3 Type of service

4.1.4 Name of technician completing the maintenance

4.2 The Contractor shall document services rendered on a legible field service report and deliver to the Plant Supervisor or designee immediately following the completion of service work.

4.3 The reports shall summarize the work performed, document the names of technicians performing the work, arrival and departure times, issues found, and any deviations from planned work.

4.4 An electronic copy of the sanitization report shall be emailed to the point of contacts in PDF within 3 days of completed service

4.5 The Contractor shall immediately notify SPS of any urgent repairs that will affect safety of the system.

5.0 Contractor Qualifications:

5.1 Contractor should be certified to work with Evoqua equipment.

6.0 Other General Information:

6.1 Contractors shall check in with the Supervisor of SPS or designee, and sign in with arrival time, name of technician(s), and general nature of the visit. Check in is mandatory.

6.2 The Contractor shall sign out of the plant daily logbook, with departure time, name of technician(s), and any deviations to the planned work. Check out is mandatory.

6.3 Normal working hours are 7:30 AM to 4:00 PM Monday through Friday excluding Federal Holidays.

6.4 Sanitation of the SPS DI line must occur Monday – Friday at 5AM

6.5 Place of Performance is: Corporal Michael J Crescenz Veterans Affair Medical Center (CMCMC) 3900 Woodland Ave Philadelphia, PA 19104

6.6 Contractor is required to adhere to all safety requirements while working inside of SPS. The contractor is required to don and doff all PPE when entering and leaving SPS. PPE will be supplied by VA

6.7 Privacy: Contractor may not have access to VAMC network.

6.8 Safety Information:

6.8.1 The Contractor shall adhere to all AAMI, ANSI, OSHA, EPA, NFPA Life Safety Codes, and all other regulatory requirements.

6.8.2 In performance of this contract, the Contractor shall follow CMCMC safety policies and standards for safe work practices and take such safety precautions as the Safety Officer or designee may determine to be reasonably necessary to protect the lives and health of occupants of the building. Contractor is responsible for the supervision of all the employees while on government property. It is the contractor’s responsibility to assure compliance with the scope of work and requirements referenced in this contract. Provisions provided in the SOW are not intended to relieve the contractor of this responsibility.

6.8.3 CMCMC is a non-smoking facility.

6.8.4 Prior to the commencement of the contract, the contractor shall submit to the point of contact the Safety Data Sheets (SDS) for all potentially hazardous materials (lubricants, cleaners, working fluids, etc.) to be used in the facility in performance of the contract. The contractor shall maintain a copy of all MSDS at the chemical storage site in a location accessible to CMCMC personnel to assure compliance with all laws and requirements regarding the “Right to Know” law.

6.8.5 The point of contact is responsible to identify, provide and maintain all personal protective equipment required to perform the duties outlined in the contract. In addition, the point of contact is responsible for identifying and providing all applicable safety programs (i.e. lockout/tag out, confined space entry, universal precautions, etc.) required performing the work. Training on required safety programs and the proper use of PPE’s shall be provided, and documentation maintained by the point of contact.

7.0 VHA Supplemental Contract Requirements for Combatting COVID-19

7.1 Contractor employees who work in or travel to VHA locations must comply with the following:

7.1.1 Documentation requirements:

7.1.1.1 If fully vaccinated, contractors shall show proof of vaccination.

1. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

7.1.1.2 If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

7.1.1.3 Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by point of contact or other hospital personnel.

7.1.1.4 Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

7.1.1.5 Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

7.1.1.6 Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

7.1.1.7 Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

7.1.1.8 For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

8.0 Security Considerations

8.1 The Certification and Accreditation (authorization) (C&A) requirements do not apply. A Security Accreditation Package is not required.