SOW.docx

STATEMENT OF WORK

PREVENTIVE MAINTENANCE SERVICE OF

STERILE PROCESSING SERVICE WATER SYSTEM

AND DIALYSIS WATER SYSTEM

I. GENERAL: Preventive maintenance services for the Sterile Processing Service (SPS) water treatment system and the Dialysis water treatment system at the Milo C. Huempfner Green Bay VA CBOC located at 2851 University Avenue, Green Bay, WI 54311. The contractor must furnish all labor, supervision, travel, materials, parts, and equipment necessary to provide preventive maintenance (PM).

II. EQUIPMENT IDENTIFICATION:

Table 1. Manufacturer, model, serial number, equipment entry number, and location of equipment

III. REQUIRED TASKS/SPECIFICATIONS:

A. PREVENTIVE MAINTENANCE:

Contractor must provide all labor, travel, manuals, tools, test equipment, diagnostic software, and manufacturer scheduled replacement parts are included for preventive maintenance. The Contractor must perform PM Service to ensure that the equipment listed herein performs in accordance with the Section IV, Paragraph B of this Statement of Work (“Conformance Standards”). The Contractor must contact biomedical engineering at the equipment location prior to performing service. Upon completion of PM, the Contractor must provide to biomedical engineering checklists with worksheet originals indicating work performed, procedures utilized, and actual values obtained (as applicable) during the PM. The Contractor must provide a written description of each Preventative Maintenance Inspection (PMI). This description must include an itemized list of the procedures performed, including the electrical safety procedures utilized. PM services must include, but need not be limited to, the following:

1. Monthly check over of the dialysis water treatment system located in 2A215-GB. Including but not limited to:

a. Check RO pre-filter replacement due date.

b. Verify and record full salt level in water softener brine tank. Verify and record water softener hardness is less than or equal to one (1) grain per gallon (GPG). Verify correct time displayed on softener.

c. Verify and record blending valve temperature.

d. Inspect vent (air) filters for each of the dialysis water system storage tanks for signs of water intrusion damage or other damage. Check tank air filter replacement due dates. There are three filters. One on each of the water storage tank, bicarb mix tank, and bicarb distribution tank.

e. Verify and record that the product water free chlorine and chloramine levels are less than 0.1 mg/L. This sample is taken at the sample port between the worker carbon tank (first tank) and polisher carbon tank (second tank) in each series after at least 15 minutes of operation.

f. Verify and record booster pump pressure output in PSI (determine proper operating levels).

g. Verify and record resistivity of product water of the final DI bed is greater than 5 MΩ/cm.

h. Verify and record appropriate input, output, and pressure changes for the following components of the dialysis water system:

i. Reverse Osmosis Pre-filter

1. Pressure change should not exceed 10 psi.

ii. Softener

iii. Carbon

iv. Endotoxin-Retentive Filters (Post filter/final filters)

1. Pressure drop across the filters must be less than 15 psi.

v. Distribution loop

i. Verify and record inlet, pump, feed, and concentrate pressures of the RO system.

j. Verify and record product flow rate, concentrate flow rate, and recirculation flow rate.

k. Verify and record inlet TDS, product TDS, and percent rejection.

2. Monthly delivery of eight (8) 50-pound solar salt bags for the dialysis water treatment system.

3. Monthly disinfect of reverse osmosis (RO) and loop of dialysis water treatment system to AAMI standards.

4. Bi-monthly (every two months) replacement of one (1) 14” anion tank, one (1) 14” cation tank, and one (1) 14” mixed-bed tank on the tri-bed deionizer portion of the SPS central sterile water treatment system located in room 1G024-GB.

a. Includes delivery, installation of new tanks, and removal of exhausted tanks.

5. Quarterly check over of the SPS central sterile water treatment system.

a. Including but not limited to verification of operating pressures, pump operation verification, resistivity meter reading verification, and check of operating hours on UV bulbs.

6. Quarterly replacement of two (2) 14-inch carbon tanks for the dialysis water treatment system.

a. Includes delivery, installation of new carbon tanks, and removal of exhausted tanks.

b. New carbon tanks are installed in the polisher position. Existing polisher tanks are moved to working position. Exhausted carbon tanks from the working position are removed.

7. Quarterly replacement of one (1) Hydronix SWC-45-2005 five(5)-micron reverse osmosis pre-filter for the dialysis water treatment system.

a. Includes delivery and installation.

8. Quarterly replacement of 14-inch tri-bed deionizer (DI) exchange tanks in dialysis water treatment system.

a. One (1) 14-inch cation DI exchange tank, one (1) 14-inch anion DI exchange tank, and one (1) 14-inch mixed-bed DI exchange tank per quarter.

b. Includes delivery, installation of new DI tanks, and removal of exhausted tanks.

c. New mixed-bed DI tank is installed in the polisher position. Existing mixed-bed polisher tank is moved to working position. Exhausted mixed DI tank from the working position is removed.

9. Semi-annual (every six months) replacement of one (1) 14” carbon tank for the SPS central sterile water treatment system located in room 1G024-GB.

a. Includes delivery, installation of new carbon tanks, and removal of exhausted tanks.

10. Semi-annual (every six months) replacement of final filter part number FPA-02-20-A for the SPS central sterile water treatment system located in room 1G024-GB.

a. Includes delivery and installation.

11. Semi-annual (every six months) replacement of two (2) 14” Cation and three (3) Anion Deionizer Tanks on the SPS central sterile cart washer water treatment system located in room 1G023A-GB.

12. Semi-annual (every six months) replacement of two (2) Mar Cor 50-203 endotoxin retentive filters (final filters/post filters) for the dialysis water treatment system.

a. Includes delivery and installation.

13. Annual replacement of UV bulbs in the Aquafine, model SL-1, UV water treatment portion of the SPS central sterile water treatment system located in room 1G024-GB.

a. Includes delivery and installation.

14. Annual validation and calibration of the Mettler-Toledo Thornton Model M300 resistivity monitor used on the SPS central sterile water treatment system located in room 1G024-GB.

15. Annual replacement of three (3) Mar Cor FP-02-10-E, 0.2-micron vent (air) filters for the dialysis water treatment system storage tanks.

a. One each per year for the bicarb system mix tank, bicarb distribution tank, and water storage tank.

b. Includes delivery and installation.

16. Annual AAMI test of dialysis water treatment system.

17. Annual calibration of AmeriWater Dialysis Alarm Panel Model 00850231 Serial Number 9515547.

18. Bi-annual (every two years) replacement of quartz sleeves in the Aquafine, model SL-1, UV water treatment portion of the SPS central sterile water treatment system located in room 1G024-GB.

a. Includes delivery and installation.

b. Replacement to occur in July 2021 and July 2023.

B. Conformance Standards:

Contractor service must ensure that the equipment listed herein functions in conformance with the latest published edition of NFPA-99, UL, OSHA, AAMI, TJC, VA, Federal, State, local, EPA and American National Standards Institute (ANSI) standards.

Contractor service must also ensure that the equipment performance/specifications are equal to or exceed the performance/specifications when the equipment was originally accepted after procurement.

All software upgrades/updates must also be included in this contract except for upgrades that provide new features or capabilities or that require hardware changes. Vendor will provide system engineering changes for bug fixes.

V. HOURS OF COVERAGE:

A. Normal hours of coverage are 7:00 AM – 4:30 PM CST, Monday through Friday, excluding holidays. All service will be performed during normal hours of coverage unless requested or approved by COR or their designee.

B. Federal Holidays observed by the VA are:

C. Biomedical Engineering must be contacted prior to arrival to confirm day and time for performing service. Upon arrival, check in at the main desk with the police and contact Biomedical Engineering to escort you to the service location.

VI. DOCUMENTATION/REPORTS:

Documentation must include detailed descriptions of maintenance performed and parts replaced to maintain the equipment in accordance with Section IV, Paragraph B of this Statement of Work (“Conformance Standards”). The Vendor Engineering Service Report (ESR) must only reference and report on equipment covered by this contract and must not be grouped with equipment covered under separate contracts. Each ESR must, at a minimum, legibly document the following data in complete detail:

a. Name of Contractor and Contract Number.

b. Name of FSE who performed services.

c. Contractor service ESR number/log number

d. Date, Time (starting and ending), equipment downtime and hours on-site for the service call.

e. Description of problem reported by COR/End User (if applicable).

f. Identification of equipment to be serviced: Inv. ID Number (EE Number), manufacturer’s name, device name, model number, serial number and any other manufacturer specific information or identification information.

g. Itemized descriptions of service performed including:

Labor and Travel, Parts (with part numbers) and Materials and Circuit location of problem/corrective action.

h. Signatures of FSE performing services and a VA employee who witnessed the services described.

The Contractor must design/develop an ESR report form that, at a minimum, incorporates the above criteria. The form must be on standard 8 1/2 x 11 paper and must be approved by the COR prior to use and implementation.

VII. QUALIFICATIONS:

Vendor must be an authorized 510K dialysis vendor.

Vendor must be an authorized AmeriWater dealer.

“Fully Qualified” is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this contract. For field experience, the FSE(s) has a minimum of two years’ experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on equipment identified in this contract.

The FSEs must be authorized by the Contractor to perform the maintenance services. All work must be performed by “Fully Qualified” competent FSEs. The Contractor must provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC. The contractor must meet The Joint Commission requirements for proving competency of service provider. The contractor must provide job title, job description, and qualifications of all that will or may provide service. The CO may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing any VA equipment. The CO or COR specifically reserves the right to reject any of the contractor's personnel and refuse them permission to work on the VA equipment.

If subcontractor(s) are used, they must be approved by the CO; the Contractor must submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

VIII. PARTS

The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied must be compatible with existing equipment. The contractor must use new or rebuilt parts. All parts must be of current manufacture and have complete versatility with the presently installed equipment. All parts must perform identically to the original equipment specifications. Rebuilt parts, used parts, or those removed from another unit, must not be installed without specific approval by the CO or the COR.

IX. SERVICE MANUALS, TOOLS, EQUIPMENT:

The government will not provide tools, test equipment, service manual, or service diagnostic software to the contractor. The contractor must obtain, have on file, and make available to its FSE’s all operational and technical documentation (such as; operation and service manuals, schematics, and parts lists) which are necessary to meet the performance requirements of this contract. The location and listing of service data manuals, by name and/or the manuals themselves must be provided to the CO upon request. Test equipment calibration must be traceable to a national standard. Test equipment calibration certification must be provided to the CO upon request.

X. REPORTING REQUIREMENTS FOR SERVICES BEYOND CONTRACT SCOPE:

The Contractor must immediately, but no later than 24 hours consecutive hours after discovery, notify the CO and COR in writing of the existence or development of any defects in, or repairs required, to the scheduled equipment which the contract considers he/she is not responsible for under the terms of the contract. The Contractor must furnish the CO and COR with a written estimate of the cost to make any necessary repairs. Any charges or work performed outside of the scope of this statement of work must be approved by the COR or CO prior to completion.