P01 - SOW RO.pdf

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Statement of Work

Hemodialysis Reverse Osmosis Preventive Maintenance and Service Coverage

1. REQUIREMENT:

This requirement is for a firm-fixed price service contract for preventative maintenance and repair service coverage for the Ameriwater MediQa hemodialysis central Reverse Osmosis (R.O.) water purification system owned by the Columbia VA Health Care System, Columbia, SC utilized by the Nephrology department. Specific models and serial numbers are listed in the performance requirements below.

2. BACKGROUND:

The CVAHCS Medical Center is a 216-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in Columbia, South Carolina and provides primary, secondary, and some tertiary care. Annually, the Medical Center serves approximately 56,116 patients. Satellite outpatient clinics are located in Anderson, Greenville, Florence, Orangeburg, Rock Hill, Sumter, and Spartanburg, South Carolina.

The Nephrology service for the facility owns and operates a central R.O. water purification system that provides treatment water to sixteen hemodialysis stations. At least weekly, these systems receive heat disinfection along with monthly acid-based disinfection in order to prevent any bacterial or negative growth within the systems.

The dialysis unit sees patients weekly, Monday – Saturday from 04:30am – 6:30pm.

3. PERIOD OF PERFORMANCE:

This is a requirement for semi-annual preventive maintenance services and repair service coverage. This requirement is for Base year and four (4) renewal options. The Period of performance shall be as follows:

BASE YEAR August 31, 2025 through August 30, 2026 OPTION YEAR 1 August 31, 2026 through August 30, 2027 OPTION YEAR 2 August 31, 2027 through August 30, 2028 OPTION YEAR 3 August 31, 2028 through August 30, 2029 OPTION YEAR 4 August 31, 2029 through August 30, 2030

Due to the operations requirements of the hemodialysis section, work cannot be performed during normal hours and must be accomplished during non-working hours, 6:30 PM or later EST

Monday through Friday except federal holidays. If extended hours are required by the contractor they must notify COR/ACOR and the owning department prior to scheduling the work.

4. PLACE OF PERFORMANCE:

WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209

The equipment is located in Building 100 within the Hemodialysis department (fifth floor, north wing). Please schedule with COR/ACOR prior to any service visits.

5. PERFORMANCE REQUIREMENTS:

A. A Contracting Officer Representative (COR) and/or Alternate Contracting Officer Representative (ACOR) shall be assigned to this procurement and written notification shall be provided to the Contractor after award.

a. Scheduling of work performance shall be arranged through the designated COR/ACOR assigned.

B. The Contractor shall provide full Preventive Maintenance and repair service coverage for the Ameriwater MediQa hemodialysis central Reverse Osmosis (R.O.) water purification system with an integrated HeatSan disinfection system owned and used by the Columbia VA Healthcare System. A breakdown of the services to be provided is as follows:

a. Preventive Maintenance, in accordance with manufacturer recommendations and the following requirements, on all equipment listed in this SOW.

i. Central Reverse Osmosis (R.O.) System Weekly Requirements:

1. Each week, the vendor shall provide either a recommended disinfection or cleaning, depending on system schedule.

Bi-weekly Requirements:

1. Disinfect central R.O. loop piping, rotating the use of a manufacturer-approved acid cleaner and bleach.

2. Clean the R.O. system with manufacturer recommended cleaning solution.

3. Draw AAMI water samples and prepare for shipping to VA hospitals’ lab of choice

Monthly Requirements:

1. Disinfect central R.O. and R.O. water loop piping

2. Replace two (2) 20” 5µm BB system pre-filters

3. Replace one (1) R.O. pre-filter 5µm 20” BB

4. Draw AAMI water samples and prepare for shipping to VA hospitals’ lab of choice

5. Test and calibrate R.O. system to manufacturers’ specifications

6. Test and calibrate R.O. system and heat disinfection monitors and alarms.

7. Provide minimum of 10 bags of salt for brine tank.

8. Review system operations and log book for discrepancies.

9. Check operation of all timers and control valves.

10. Inspect carbon filters for integrity and expected life.

11. Inspect ultraviolet (UV) light and clean UV quartz sleeve when serviced.

12. Inspect and ensure all internal pressures, flow rates, water qualities, membrane effectiveness, electrical interlocks, and protection devices are in operating order and are performing to manufacturers’ recommended specifications.

13. Inspect water distribution system to check for proper operation and integrity, and ensure distribution system loop pressure is ideal.

14. Prepare monthly written report and supply it to the Biomedical Engineering department by the first week of each month.

15. Clean and disinfect R.O. with manufacturers’ recommended acid cleaning solution.

Quarterly Requirements:

1. Clean and disinfect R.O. with manufacturers’ recommended cleaning solution.

2. Check system booster pump and ensure system operation.

Semi-Annual Requirements:

1. Replace 0.2µm endotoxin filter

2. Replace UV bulb and quartz sleeve

Annual Requirements:

1. Re-bed two (2) 8 cubic foot carbon tanks with standard carbon

2. Replace UV bulb and sleeve

3. Clean brine tank

4. Clean incoming water blending valves

5. Perform full Preventive Maintenance on R.O. system as per the manufacturer guidelines.

b. Services and parts to restore damaged equipment to its normal operating condition.

c. Any and all replacement parts must be Original Equipment Manufacturer (OEM) supplied parts.

d. All software and firmware updates required or recommended by the manufacturer, including proprietary operating system software enhancements.

e. Performance verification will be required at the conclusion of every preventive maintenance and emergency repair event. This verification procedure shall include performance testing for accuracy and precision of the system.

f. Each maintenance will include inspection for internal and/or external causes of mechanical, electrical, of software-related system failures.

C. Contractor shall provide all personnel, parts, tools, test equipment, service manuals, computer software and necessary upgrades/patches/firmware changes, applications support and schematics necessary to effect repairs and preventive maintenance procedures on the listed equipment. Due to the operations requirements of the hemodialysis section, work cannot be performed during normal hours and must sbe accomplished during non-working hours, 6:30 PM or later EST Monday through Friday except federal holidays. The following equipment shall be covered under this contract:

MODEL PART NUMBER SERIAL NUMBER

AmeriWater MediQa Central R.O. MDR240021 AmeriWater HeatSan HeatSan 00HS208 HS0002

D. The Contractor’s service representative (CSR) shall contact the COR/ACOR to schedule an inspection or prior to responding to a service call.

a. CSR shall acknowledge receipt of a service call within 2 hours and shall arrive on the premises to effect repairs within 24 hours.

b. CSR shall provide, upon request, suitable loaners for contracted equipment that shall be out of service for more than 48 hours.

i. Equipment repaired by the CSR or loaned to the Medical Center by the contractor shall be calibrated and safety tested by the CSR before being placed into service.

ii. CSR shall not deviate from this protocol without the prior approval of designated COR.

E. The contractor’s service representative shall present the field service report to a representative of COR/ACOR for an authorized signature, leaving one legible copy for inclusion in the individual equipment’s Historical Maintenance Record. Contractor shall also provide COR/ACOR with a legible copy of the calibration reports including numerical values of measurements taken within 5 business days.

F. Preventive maintenance shall include, but not be limited to the following:

a. Electrical safety testing

b. Lubrication

c. Adjustments

d. Calibration

e. Testing and replacement of faulty parts and parts which are likely to fail at no additional charge

f. Returning the instruments or equipment to the operating conditions specified by the manufacturer, NFPA 99 and VA MP-3 guidelines.

G. The contractor shall be responsible for providing and applying any and all recommended manufacturer’s software updates, upgrades, and patches during the execution of this contract. Timing and device availability shall be coordinated with COR/ACOR.

EXPERIENCE/CERTIFICATION

All work shall be performed by competent, experienced personnel qualified to work on the specified equipment in accordance with good manufacturing practices. Prior to award Contractor shall provide factory training certificates/competencies for all technicians assigned to service the specified equipment, in accordance with JCAHO standards. Technicians assigned to provide services to the equipment shall provide evidence of OEM training in the form of factory training certificates that are within their expiration date. These OEM certifications shall clearly identify the technicians’ name, the training center, and the equipment the technician was trained to service. Technicians shall provide certifications that indicate they were trained on all items / equipment listed as to be covered under this contract. Such certificates/competencies are to be submitted to COR/ACOR within 30 days from date of contract award. Failure to provide required documentation shall result in non-payment of invoices for this service.

Per ISO 9001, contractor shall list all the test equipment that had been used along with the details on the service report during any service associated with the medical equipment to include, but not limited to:

• Test equipment name

• Equipment Calibration due date

• Model

• Serial number

• Manufacturer

REPORTS:

The Contractor’s Service Representative shall present a Field Service Report to the designated COR for an authorized signature, leaving one legible copy for inclusion in the individual Equipment’s Historical Maintenance Record.

Contractor shall provide the designated COR with a legible copy of the Calibration Reports including numerical values of measurements taken within five (5) business days.

A copy of the Preventive Maintenance Inspection procedure (including Qualitative and Quantitative tests) used by the Contractor Service Representative for each item listed on the contract, shall be made available upon request.

SAFETY:

Contractor shall ensure all tools and equipment are secured at all times.

• Tools and equipment must be removed from open areas or stored in secured location during breaks, lunch, and/or at the end of each work day.

• All debris must be removed from the facility upon completion of service each day.

Operation of the equipment for testing, servicing, or any other purpose shall be done only in secured areas designated by the COR/ACOR and away from the general patient population.

Contractor shall ensure proper signage and/or blockage of service area is provided and clearly visible to ensure patient/employee safety is adhered to.

Smoking is not permitted within the facilities at any time. All smoking shall be conducted in designated smoking areas only.

6. INVOICES:

a. Payment shall be made monthly in arrears, invoices shall be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain:

Invoice Number and Date Contractor’s Name and Address Accurate Purchase Order Number Supply or Service provided Period Supply or Service Provided Total Amount Due

b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge.

c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

d. Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP http://www.tungsten-network.com/us/en/ http://www.tungsten-network.com/us/en/ mailto:VA.Registration@Tungsten-Network.com http://vafsccshd@va.gov http://www.fsc.va.gov/EINVOICE.ASP

7. TERMINATION FOR CONVENIENCE: In accordance with FAR 52.212-4 (l) The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience.

8. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents shall be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

8. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS: