Attachment 1 SOW Water testing and RO maintenance9-23.docx

Wilmington, DE VA Medical Center Wilmington, DE 19805

SERVICE CONTRACT SCOPE OF WORK

SPD Reverse Osmosis water testing and maintenance

1.0 General: This is a non-personal services contract to provide water testing and Reverse Osmosis (RO) equipment maintenance for the Sterile Processing Services (SPS) Decontamination Room in support of the support of the Wilmington VA Medical Center. This service is required to be compliant with VA Regulations 2020-08-28 and the AAMI TIR 34 Standards. The tests will be performed in accordance with this Scope of Work.

2.0 Objective: The purpose of this service contract is to be compliant with the following and they are all listed in the attachments in 9.0:

2.1 AAMI TIR 34

2.2 Memorandum 2020-08-28 Required critical water systems for testing and report for Sterile Processing Services (SPS)

2.3 ANSI/AAMI ST 79_2017

3.0 Scope for Water Testing

3.1 Water Testing shall be on the following:

3.1.1 Monthly testing for 3 Medivators for pH, bacteria, and LAL. See Attachment J1.

3.1.2 Monthly testing of sinks used for reprocessing for pH, bacteria, LAL. Required frequencies are in the table below:

Ionic Contaminants

Feedlines into the Facility Annually

Facility Annually

heterotrophic plate count

3.2 Testing shall consist of:

3.2.1 Monthly: Monthly Testing is required to be conducted at least 20 days from previous monthly testing.

3.2.2 Quarterly: Quarterly Testing is required to be conducted at least 75 days from previous quarterly testing and will coincide with the monthly testing.

3.2.3 Semi-Annually: Semi-Annual Testing is required to be conducted at least 140 days from previous annual testing and will coincide with the monthly testing.

3.2.4 Annually: Annual Testing is required to be conducted at least 320 days from previous annual testing and will coincide with the monthly testing.

3.2.5 On Demand

3.2.5.1 Endotoxins

3.2.5.1.1 After system modifications.

3.2.5.1.2 After repeat positives for bacteria.

3.3 Testing requirements (reference AAMI TIR)

3.3.1 Ensure all points are flushed/ running after for sixty (60) seconds prior to sample collecting into the container.

3.3.1.1 Container requirements will follow all standards in the attachments of this SOW.

3.3.1.2 Sterile, endotoxin-free container.

3.3.1.3 Shall not be made of polypropylene.

3.3.1.4 Shall follow transport and temperature requirements consistent with AAMI Guidelines.

3.4 Retesting

3.4.1 In the event that retesting is required, the Service Provider must be available to draw samples and begin retesting within 48 hours of notification or on the next testing day as described in this SOW.

3.4.2 Retesting is at the discretion of the Contracting Officer’s Representative and will be based on accurate findings at the same rate as the initial test.

3.4.3 If the retesting is on one of the Medivators the samples will then be drawn from 2 bowls inside the machine. Sterile Processing Services staff shall cycle Medivators per IFU for collection and collect samples from within bowls.

3.4.4 Retesting will not be conducted on Fridays, Saturdays, Sundays, or Holidays.

3.5 Reporting

3.5.1 Chain of Custody Requirements

3.5.1.1 The test form will have actual signatures for transfer.

3.5.1.2 The test form will have date and time of all transfers.

3.5.1.3 The test form will include temperature of the samples requiring temperature control at the point of sampling and each transfer.

3.5.1.4 Note time sensitive samples from sample taken to plating the sample must follow all standards in this SOW.

3.5.1.4.1 Additional Wilmington VAMC Requirements: Heterotrophic Plate Count-8 hour maximum hold time before processing.

3.5.1.5 Report form will have column titles at the top of each column that identify standards for low to high limits.

3.5.2 Reporting requirements

3.5.2.1 At the time of sampling, the Service Provider shall provide the following:

3.5.2.1.1 Name of person collecting the sample

3.5.2.1.2 Date & time

3.5.2.1.3 Identification of the sample:

3.5.2.1.3.1 Identification Examples: RO Loop Start, Instrument Nozzle, Medivator 1, Medivator 2

3.5.2.1.4 Date of analysis

3.5.2.1.5 Laboratory and person responsible for performing the analysis

3.5.2.1.6 Analytical technique/method used

3.5.2.1.7 Results of analysis

3.5.2.1.8 Temperature of sample

3.5.2.1.9 Building number, room number, room name

3.5.2.2 Any discrepancies found on reports missing required information are required to be corrected within 2 days. A trend (defined as two or more instances of discrepancies) may result in notice of concern or other action as determined by the Contracting Officer.

3.5.3 Results, in AAMI standard units, shall be provided to the SPD Chief or assigned back-up within 3 days of the sample taking.

3.5.3.1 Results shall be provided via email on PDF format.

3.5.3.2 Vendor shall notify Wilmington VAMC COR immediately upon positive bacteria or endotoxin results.

4.0 Scope for Equipment Maintenance/System Performance Review: The Contractor shall inspect water system, which includes inspection of the items listed below.

4.1 The Contractor shall inspect and record operations data in the log book.

4.2 The Contractor shall inspect and document Feed Water Chemistry data.

4.2.1 Contractor shall sample system feed water before pretreatment to check for hardness and chlorine levels with appropriate test kits.

4.2.2 Record findings in the service report.

4.3 The Contractor shall inspect and RO Data

4.3.1 Inspect RO overall appearance, check pump pressure, permeate flow, recycle flow, concentrate flow and RO membrane rejection.

4.3.2 Record findings in the service report.

4.4 Inspect & Record Control Panel Data

4.4.1 Inspect control panel for correct operation and indicators on the panel, including control switches, indicator lamps, meters and local alarms.

4.4.2 Record any issues in the service report.

4.5 Inspect & Record Remote Alarms Data

4.5.1 Inspect remote alarms for correct operation, including audible and visual alarms.

4.5.2 Record any issues in the service report.

4.6 The Contractor shall provide rental carbon tanks: 3.61 cu.ft.

4.6.1 Contractor is responsible for installing, placing and connecting the tank in the designated area on-site.

4.6.2 Contractor shall remove the old tank and from Government facility.

4.6.3 The Government shall contact the Contractor if the carbon tank is close to being exhausted or require exchange.

4.6.3.1 This service shall be considered part of the service and shall not be considered an emergency.

4.7 The Contractor shall clean membranes in the RO system.

4.7.1 Clean the RO Membranes using Low and High pH cleaners.

4.7.2 Rinse the system

4.7.3 Use test strips to verify that all chemical is clear from the system.

4.8 The Contractor shall disinfect RO/Loop/Storage Tank

4.8.1 Disinfect the RO Loop and/or Storage Tank using disinfectant.

4.8.2 Use test strips to verify that the disinfectant is clear from the Loop and/or Storage Tank.

4.9 The Contractor shall inspect and replace the RO pre-filter.

4.9.1 The contractor is responsible for old filter disposal.

4.10 The Contractor shall inspect and replace Pyrogen

4.10.1 The contractor is responsible for Pyrogen disposal.

4.11 The Contractor shall inspect and replace Vent Filters.

4.11.1 The contractor is responsible for old filter disposal.

4.12 The Contractor shall inspect and replace UV Lamp and Quartz Sleeve

4.12.1 The Contractor is responsible for disposal of all old parts/equipment.

4.13 The Contractor shall provide rental DI Tanks:

4.13.1 Tanks shall be 14x47, 3.61 cu ft.

4.13.1 Contractor is responsible for installing, placing and connecting the tank in the designated area on-site.

4.13.2 Contractor shall remove the old tank and from Government facility.

4.13.3 The Government shall contact the Contractor if the carbon tank is close to being exhausted or require exchange.

4.13.3.1 This service shall be considered part of the service and shall not be considered an emergency.

4.14 LAL Water Test (Service Provider to Pull) x3 — RO product, loop start, loop end

4.14.1 Service Provider will pull test.

4.14.2 Testing will meet 1S013959 testing standard for LAL (Colony) and Bacteria (Endotoxin) Units.

4.14.3 Results will be sent at the time of full incubation and/or if a failure level is met.

14.15 Bacteria Water Test (Service Provider to Pull) -x3 RO product, loop start, loop end

14.15.1 Service Provider will pull test. Testing will meet 1S013959 testing standard for LAL (Colony) and Bacteria (Endotoxin) Units.

14.15.2 Results will be sent at the time of full incubation and/or if a failure level is met.

14.15.3 Bacteria samples to be taken before RO cleaning and disinfect.

14.16 TEST,SPS AAMI TIR 34,TOC - x2 — RO Product, loop start

14.16.1 Customer will pull test.

14.16.2 Testing will meet IS013959 testing standard for LAL (Colony) and Bacteria (Endotoxin) Units.

14.16.3 Results will be sent at the time of full incubation and/or if a failure level is met.

4.17 Reporting for equipment maintenance:

4.17.1 Service Provider's service technician will document any issues in the service report that are outside acceptable ranges as defined in the manufacture’s specifications or associated references and required to be sent to the SPD Chief within 3 days of findings.

4.17.1.1Any issues found during inspection of the operations log book.

4.17.1.2 Water Feed Chemistry data.

4.17.1.3 RO data results

4.17.1.4 Control Panel Data results

4.17.1.5 Remote alarms data.

5.0 Scheduling table

6.0 Emergency Services and other tests:

6.1 Emergency Services for retesting and for Endotoxins will be covered in CLINs 0009, 1009, 2009, 3009, and 4009. Emergency Repairs will be covered in CLINs 0010, 1010, 2010, 3010 and 4010. Services are only for This is on a case-by-case basis and follows limits: parts/services above $2,500.00 and up to $25,000.

6.1.1 If system is modified or sanitized because of repeated positives, Endotoxin test is required.

6.1.2 Prior to engaging in service or repair under this paragraph the Service Provider shall obtain written approval from the CO (funds are not available on subject CLIN) or the Government POC/COR (funds are available on subject CLIN). Email is an acceptable form of written approval. Any work performed without CO or COR/Government POC approval shall not be approved for payment and considered and Unauthorized Commitment. Testing shall be conducted IAW with rates found in the subject CLIN unless further discounts are applied.

6.2 The contractor shall ensure that emergency services will be available 24 hours a day | 7 days a week including holidays.

6.2.1 If any work is to be performed outside of the scope of the maintenance agreement, the Service Provider shall submit a proposal to the COR and Bio-Med Shop supervisor and obtain either a purchase card number or signed contract action from a warranted contracting officer. prior to commencement of any work.

7.0 Service Provider Qualifications

7.1 Service Provider laboratory qualification requirements: AAMI Accredited.

7.2 Service Provider employee requirements: Trained per AAMI collection and processing standards.

8.0 Other general information

8.1 Hours of operation & scheduling

8.1.1 No sampling on Holidays, Fridays, Saturdays, and Sundays

8.2 Testing coordination will be with the COR. COR information will be provided at time of contract award.

8.3 Place of performance will be the Wilmington, Delaware VA Medical Center

8.4 All employees of the Service Provider shall comply with the VA security management program and obtain permission of the VA police, be identified by service and employer, and restricted from unauthorized access.

8.5 Regulatory Compliance – EOSH requirements for work performed at the above location can be found in:

8.5.1 Volume 29 of the Code of Federal Regulations, Part 1910 – Occupational Safety for General Industry

8.5.2 Volume 29 of the Code of Federal Regulations, Part 1926 – Occupational Safety for The Construction Industry

8.5.3 Volume 40 of the Code of Federal Regulations – Protection of The Environment

8.5.4 Volume 49 of the Code of Federal Regulations, Part 397 – Transportation of Hazardous Materials

8.5.5 Title 7 of the Delaware Code – Conservation

8.5.6 Title 16 of the Delaware Code – Health and Safety

9.0 Attachments

9.1 AAMI TIR 34 Standards

9.2 2020-08-28 Required Critical Water Systems Testing for SPS

9.3 ANSI_AAMI ST79_2017

9.4 Medivator Water Sample Collection Process

10.0 Task Orders

10.1 All worked performed under this contract shall only be performed by the contractor via Government issued task orders award against the base contract.

10.2 The Task Order will include the line items, quantities and associated pricing. All pricing shall be determined directly from the base contract Pricing Schedule.

10.3 The Task Order will include the location of the work, and an effective start and ending dates for the period of performance.

10.4 Invoices will be paid upon satisfactory completion of all project-specific tasks, requirements, and acceptance. Individual purchase order numbers will be issued on each task order for invoicing purposes.

10.0 VHA Supplemental Contract Requirements for Combatting COVID-19

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

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. 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.

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.

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 Contracting Officer Representatives (CORs) or other hospital personnel.

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.

2. 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.

a. 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.

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

1. 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.