RO and DI Water Statement of Work.docx

02 Dec 2019

Statement of Work

Preventive Maintenance for Sterile Processing Reverse Osmosis system, water softener system, and Deionized Water Samples

1. Scope: The Contractor shall provide all services, labor, parts, materials, and equipment necessary for the service and maintenance of the Culligan Reverse Osmosis (RO) water system, water softener system, and Deionized water (DI) samples located in the Sterile Processing Division at Naval Medical Center San Diego (NMCSD). The period of performance is 01/10/2019-01/09/2024.

Contractor shall service and maintain the equipment 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) standards for critical water systems, and Joint Commission recommendations.

2. Definitions: As used throughout this work statement, the following terms shall have the meaning set forth below:

2.1. Service and maintenance: (a) any modification, adjustment, or replacement of the equipment that corrects a malfunction and effectively brings the equipment into material conformity with the technical specification for that equipment as designated by the original equipment manufacturer (OEM), (b) a procedure or routine that, when observed in the regular, proper operation of the equipment, avoids the material adverse effect of the applicable nonconformity, (c) any measures performed that assure the continued operation of the equipment or returns the equipment to its designed efficiency and capacity, (d) replacement of a piece of equipment on a one-for-one basis in order to provide a substitute of equal or greater value in lieu of a damaged or defective device for compensation, return, or refund of equipment.

2.2. Contracting Officer (KO): A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

2.3. Technical Representative (TR): A Government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

3. Location:

Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134-5000

4. Requirements:

4.1. General Performance Requirements:

4.1.1. The Contractor shall provide on-site services to include all periodic planned maintenance and unscheduled repairs in accordance with manufacturer specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error.

4.1.2. The Contractor may use third party service vendors not limited to the Original Equipment Manufacturer (OEM), however, these vendors must be approved in advance by the KO and TR. The Contractor must submit a list of any sub-contractors they intend to use as third party service vendors to the KO and TR for approval. Third party service vendors shall not perform any work under this contract prior to such approval.

4.1.3. Ensure that only fully-qualified field engineers and/or technicians shall be employed in the performance of any and all work performed under this contract. Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product and collection of water samples. Upon request, Contractor shall provide written assurance of the competency their personnel as well as a list of credentials for personnel. The KO and/or TR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

4.1.4. Test equipment: Test equipment calibration shall be traceable to National Institutes of Standards and Technology (NIST traceable). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by TR, the Contractor and/or service vendors shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on NMCSD equipment.

4.1.5. Field Service Reports: Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR) to the Duty Staff at NMCSD Sterile Processing Department and DSS Logistics at NMCSD. All FSR's shall be submitted within 72 hours of completion of service.

The Contractor or their representative shall complete the FSR to include, at a minimum, the following:

Field Service Reports will be sent to the following:

POC: Keith Freeman – Division Officer keith.j.freeman.mil@mail.mil POC: Tresa Thomas – Business Manager tresa.e.thomas2.civ@mail.mil POC: DSS Logistics usn.san-diego.navmedcensanca.list.nmcsd-dsslogisticsoffice@mail.mil

Completed Field Service Reports are required prior to acceptance of any invoice. Failure to submit a Field Service Report can result in delay of payment or rejection of invoice from Government. It is highly recommended that the Contractor attach a copy of the Field Service Report to their Wide Area Workflow Invoice in order to expedite invoicing process.

4.2. NMCSD Preventive Maintenance Requirements:

4.2.1. Preventive maintenance shall be performed in a manner which will minimize corrective maintenance and will include but is not limited to: calibration, adjustment, lubrication, updating software for security, safety, or system functionality issues, testing required to maintain a safe environment of care, electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

4.2.2. Make repairs to the extent necessary, as determined by inspection tests or disassembly, to ensure a functional system that will efficiently serve its intended purpose and the technical specification for that equipment as designated by the original equipment manufacturer.

4.2.3. Installation of system update changes to resolve specific product reliability problems. Hardware and software upgrades, defined as those changes that enhance or add product features, are not included.

4.2.4. Preventive Maintenance shall be performed as per the schedule noted in section 4.1.1, with these scheduled preventive maintenance actions to be coordinated with NMCSD Sterile Processing after contract award.

4.2.5. Preventive Maintenance Completion: Contractor must insure that 100% of periodic maintenance is performed within two (2) days of the due date.

4.2.6. Equipment in Use: If, for reasons beyond the Contractor’s control, equipment is not made available for maintenance, the Contractor shall immediately notify the TR. Contractor shall arrange a means of complying with the requirements for preventative maintenance at no additional cost to the government.

4.3. NMCSD Corrective Maintenance Requirements:

4.3.1. Correct inoperable condition in a timely manner. Contractor shall respond to corrective maintenance requests no later than two (2) hours after telephone notification from Sterile Processing. Service should be provided within one (1) business day of notification, Monday-Friday, between the hours of 0800-1500.

4.3.2. Provide only the work necessary to restore the equipment to a properly serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts are not necessary.

4.3.3. Equipment improvements/modifications shall be made only upon written approval and direction. This includes software updates to the device. All updates, improvements, or modifications performed shall be notated on the FSR or equivalent.

4.3.4. Notify Sterile Processing immediately upon receipt of safety recall notices or upon discovery of any other safety hazard discovered during the performance of work.

4.3.5. Ensure that the original design and functional capabilities shall not be changed, modified, or altered without express written authorization from NMCSD.

4.3.6. Provide suitable recommended repair equipment/tools required for the satisfactory execution of all repairs made.

4.3.7. Replacement parts shall be covered by the Contractor for the duration of the contract.

4.4. End-User Requirements:

4.4.1. Contractor shall perform an initial inspection of the Culligan Reverse Osmosis (RO) Water treatment system and water softener system.

4.4.2. Contractor shall provide routine inspections of the Reverse Osmosis (RO) water treatment system to ensure proper function and effectiveness for the intended task of supplying high quality, low conductivity critical water suitable to use in the reprocessing of surgical instrumentation, in accordance with AAMI standards for critical water (AAMI TIR 34-2014).

4.4.3. Contractor shall maintain service logs for the water treatment system and water softener system. They will keep one copy on site at NMCSD Sterile Processing. The Contractor may, at their choosing, retain an additional copy, but the primary copy shall be retained by NMCSD Sterile Processing.

4.4.4. Contractor shall provide service and maintenance for the following items. These materials and items shall be provided for as part of the services and maintenance contract at no additional charge to the government.

a. Carbon filter cartridges – 5 mic, 10” – routine inspection and replacement per manufacturer’s recommendations. Replace at a differential pressure of fifteen (15) psi.

b. ROS Membrane(s) – 4” x 40” - routine inspection and replacement per manufacturer’s recommendations. Monitor the product flow and quality. Clean or replace as needed.

c. O-rings kit – 2.5” – routine inspection and replacement per manufacturer’s recommendations. Replace the O-rings and retest before replacing the entire element.

d. Pilot valve rebuild kit – routine inspection and replacement per manufacturer’s recommendations.

e. Valve core replacement kit – routine inspection and replacement per manufacturer’s recommendations.

f. Brine valve assembly kit – routine inspection and replacement per manufacturer’s recommendations.

g. Salt delivery – refill water softener salt. Routine inspection and replacement per manufacturer’s recommendations.

h. Sanitation – completed annually. Also performed if testing values indicate a compromise in the system either due to biofouling or the water treatment application limits the microbial count in the product water. Routine inspection and replacement is per manufacturer’s recommendations.

i. Monthly DI testing & AD HOC tested if indicated – will provide all testing materials required for monthly testing. AD HOC testing will be needed and requested from Sterile Processing.

4.4.5. Feedwater: Feedwater will be supplied by the Government to the water treatment system. However, the Contractor shall inspect the feedwater supply (pipes, valves, etc.) as part of the routine service and maintenance. Additionally, the Contractor shall test feedwater routinely to ensure compatibility with water treatment system manufacturer’s requirements, to include water pressure, temperature and pH. If problems are detected in feedwater or its components, the contractor shall notify the Sterile Processing division and shall provide a report of their findings to the TR and NMCSD Facilities Department.

4.4.6. Sanitation: The Contractor shall provide sanitation/flushing of the whole Reverse Osmosis water treatment system in conjunction with the service and maintenance contract. Scheduled routine sanitation/flushing of the water treatment systems shall be performed annually per the manufacturer’s recommendations. Additionally, the contractor shall provide immediate sanitation/flushing of the water treatment systems within (3) calendar days of verbal request from Sterile Processing division at no additional charge to the Government (with up to three sanitations in a one-year time frame).

4.4.7. Water Quality Monitoring: the Contractor shall provide water testing and monitoring in conjunction with the service and maintenance contract. Water shall be tested in accordance with AAMI TIR 34-2014 guidelines. Water samples shall be taken from test port by the Belimed Washers to ensure proper functioning in the water loop. Water quality testing shall be performed monthly at a minimum; however, additional water samples may be requested by the Sterile Processing division. Six (6) additional water samples are built into the monthly contract at no extra charge to the Government. An electronic copy of the lab results must be delivered to the points of contact identified in section 4.1.5. Lab results shall be delivered within seven (7) calendar days of the sampling date. Water quality monitoring shall include at a minimum, testing for the following:

· Hardness

· pH

· Chlorides

· Bacteria

· Endotoxin

· Conductivity

· Total organic carbon

· Total dissolved solids

· Ionic contaminants

4.4.8. Contractor shall perform all necessary work to decontaminate the Reverse Osmosis water treatment system (sanitation/flushing) should a water quality test result indicate the system may have been compromised in its function and reliability to provide water that meets AAMI guidelines. Sanitation, flushing, and cleaning of the water treatment system shall be performed in a manner consistent with AAMI TIR 34- 2014 guidelines and will not be considered complete until cleared for service through multiple water quality testing and confirmation of these results with the KO.

4.4.9. Contractor shall notify the DSS Logistics and/or KO of any parts or labor required above and beyond routine service and maintenance for the water treatment system. No work shall be performed without written approval from the DSS Logistics Office or the KO. Contractor shall provide a written estimate of the costs for this service within forty-eight (48) hours of identification of an issue.

4.5. Response Time and Labor:

4.5.1. Contractor shall use commercially reasonable efforts to respond by telephone to any report of a malfunction within two (2) hours of notification from NMCSD. The Contractor shall also provide telephone consulting services, twenty-four (24) hours per day, seven (7) days a week. This consulting service shall be provided to avoid delays in contract service coverage during after-hours and weekend/holiday periods as applicable. Under no circumstances shall the Contractor assume an inquiry, via telephone or any other means, is authorization to provide services not specifically covered by the terms of the contract.

4.5.2. The Contractor shall use commercially reasonable efforts to provide on-site support within one (1) day or twenty-four (24) hours from notification by NMCSD, unless otherwise noted in Section 4.4.

4.5.3. All compensation for labor is provided for in this contract and included in the contract price.

4.5.4. Any work that would require overtime or additional charges must be approved, in writing, in advance by the KO. Any materials that would require additional charges above and beyond those already provided for under the contract must be approved, in writing, in advance by the KO.

5. Travel and Related Expenses: Contractor shall be responsible for its service related trip expense, including round trip travel, mileage, and overnight living expenses.

6. Shipment: The Contractor shall not exceed one (1) business day for shipment of all equipment coming from and/or going to NMCSD minus exceptions or conditions as previously noted in this Statement of Work or as approved by the KO. All shipping expenses/costs are provided for in this contract and included in the contract price.

7. Liability:

7.1. The Contractor shall not be liable for any loss, damage, or delay due to any cause beyond their reasonable control, including but not limited to fire, explosion, theft, flood, riot, civil commotion, war, malicious acts of mischief, or other circumstances outside of human control.

7.2. NMCSD Employees will not perform maintenance or attempt repairs to equipment covered under this contract while such equipment is under the purview of this contract without express, written concurrence from Contractor.

7.3. Insurance: Contractor shall be required to have liability insurance to cover any actions on the part of the Contractor or their sub-contractors which result in injury or death to patients, staff, visitors, or other Contractors. Coverage shall be of at least $500,000 per occurrence. Additionally, Contractor is required to have property damage liability insurance of at least $500,000. Liability insurance shall meet the requirements set forth in FAR 28.307-2.

8. Utilities, Facilities, and Equipment Access:

8.1. The Contractor may use Government utilities (e.g., electrical power, compressed air, water) that are available and required for any service performed under this contract while at Government facilities. The facilities engineer however must approve of any contractor equipment which would connect to these utilities in order to ensure compatibility with NMCSD utilities.

8.2. Any outages required in order to perform services must be approved by NMCSD Facilities Management prior to initiation of work and shall be performed per Facilities' instruction. Contractor may request Facilities assistance in performing these outages if required.

8.3. Ensure that all use, storage, transport of any materials regulated by OSHA as "hazardous", required for the performance of this contract, is in in compliance with all federal, state, and local regulations. Contractor shall have available MSDS's for any such materials on-site.

8.4. The Contractor shall protect all facilities from damage caused by the Contractor and shall repair, at no additional cost to the Government, all damages caused by the Contractor's activities. During performance of services, Contractor shall keep the site safe, neat, clean and orderly. Contractor shall be responsible for all means, methods, techniques, sequences, and procedures of the services

8.5. Access to Equipment: Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start/stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on-duty personnel responsible for such equipment.

9. Security and Safety Requirements:

9.1. The Contractor is required to submit/complete Naval Base San Diego Base access requirements for access to NMCSD. Contractor shall contact Naval Base San Diego Security Department at 619-556-1653/5336 or at https://www.cnic.navy.mil/regions/cnrsw/installations/navbase_san_diego/om/force_protection/pass_and_decal.html in order to obtain the necessary clearances to perform this contract. All costs for completing the requirements for access are the responsibility of the contractor.

While waiting for authorized access, contractor shall, at a minimum, contact NMCSD Biomed not later than 1400 on the day prior to a scheduled visit to submit the required information to complete the NMCSD Temporary Security Pass. In case of emergent repairs or service, the contractor shall wait at the NMCSD Main Gate for escort from Biomed personnel.

9.2. Identification, Parking, and Smoking Regulations at NMCSD: Field service personnel shall wear visible photo identification at all times while on the premises of NMCSD. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Information on parking is available from NMCSD Security personnel. Smoking is prohibited inside any buildings of NMCSD and is restricted to designated smoking locations only. Possession of weapons, alcohol, or pharmaceuticals that are not over the counter and not prescribed to the individual/family is prohibited on the premises. Enclosed containers, including tool kits, are subject to search. Violations of regulations may result in citation answerable in the United States (Federal) District Court. Violation of any policy which results in lost time for Contractor or his sub-contractors is the sole responsibility of the Contractor, and shall not be charged to the government. Contractor employees shall demonstrate appropriate behavior and dress at all times.

9.3. Contractor Check-In/Check-Out: Contractor is required to report to Material Management Department, Biomedical Repair Division at Building One (1), Ground Floor, Room GD-18H1 at NMCSD prior to and upon completion of any services or repair work performed.

9.4. General Safety Requirements: The Contractor shall exercise safety precautions as the TR may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. NMCSD will notify the Contractor of any non-compliance with the foregoing conditions and the action(s) to be taken. Service vendors shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. If field service engineer refuses to comply promptly, the TR may issue an order stopping all or any part of the work. Under such circumstances, the KO and hold the service vendor in contract default. Nothing in this section will be construed so as to limit the Contractor or his sub-contractors responsibilities to comply with any existing law, nor to switch jurisdictions.

9.5. Government Right of Refusal: NMCSD reserves the right to reject any of the contractor's personnel and refuse them permission to enter the premises or work on NMCSD equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include but not be limited to: behavior, attire, security concerns, immigration status.

10. Compliance with Applicable Laws: Contractor shall be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of his business. The Contractors personnel shall comply with the DoD Information Assurance Policies applicable. Contractors are required to maintain a Drug Free Workplace, as well as to require any sub-contractor to do the same. Contract shall require wage determinations and comply with applicable Federal and State worker's compensation and occupational disease statutes.

11. Modifications to Contract: Only the KO has the authority to obligate the government, and then only in writing. No modification or instruction from any party shall be construed to authorize the Contractor to take any action for which they expect compensation without written authorization from the KO.

12. Invoicing: All invoicing shall be done in accordance with this statement of work and in accordance with contract. Failure to do so may delay or interfere with payment for services rendered.