Draft SOW Water Testing .pdf

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STERILE PROCESSING SERVICE VAILDATION TESTING & CONTINUOUS WATER MONITORING FOR

BUILDING 200 LOCATED AT VA SAN FRANCISCO LOCATED AT 4150 CLEMENT ST, SAN FRANCISCO, CA

94121

STATEMENT OF WORK

The contractor shall provide Validation Testing, Continuous Monitoring Equipment Service, and a Web‐ based Data Management System to record, store, and report all data in alignment with the VA’s Assistant Under Secretary for Health for Operations 28AUG2020 Memorandum: Required critical water systems testing and reporting for Sterile Processing Services (SPS).

Validation Testing The contractor’s laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body (EMLAP, NELAP, etc.), or a state certifying body.

The contractor will provide all labor, materials, and equipment necessary to complete environmental Validation Testing of the SPS water. The contractor shall furnish sterile bottles that are appropriate for the analysis.

The contractor shall collect samples from one (1) critical water source and two (2) utility water sources for the water quality panel and from one (1) critical water source and three (3) utility water sources for the Hardness/Ionic Contaminants panel in accordance with approved laboratory procedures. The sample collector shall indicate on the Chain of Custody whether a sample is critical or utility so the lab can analyze in alignment with the specified limits of AAMI TIR 34: 2014/(R)2017 Table 1. The contractor shall furnish appropriate shipping containers and shipping labels for the transportation of samples to the laboratory. The laboratory will follow strict chain of custody procedures upon the receipt of the samples.

Validation testing shall occur at the frequencies identified in the table below for each test. The laboratory will provide a report indicating the analytical results for each sample submitted. Results shall be provided within 10 days of sample receipt and shall be immediately uploaded into the web‐based data management site and emailed in PDF format to the client point of contact. Lower limits of detection will align with AAMI TIR 34: 2014/(R)2017 recommended levels of water quality for medical device reprocessing.

Frequency Test Panels

Monthly Water Quality Panel

Bacteria ‐ Heterotrophic Plate Count (Spread Plate)

Total Organic Carbon (TOC) pH

Conductivity (for Resistivity)

Color

Turbidity

Quarterly for one year until 4 consecutive quarters

Hardness/Ionic Contaminants Panel

Hardness (Total)

Ionic Contaminants o Chloride o Iron

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Varies* LAL/Endotoxin

* Endotoxin frequency is identified by occasion per AAMI TIR 34: 2014/(R)2017: On installation, modification, or repair of the critical water treatment system or when persistent increased microbial levels are detected by heterotrophic plate count, ATP, or TOC. To simplify, the testing frequency of this parameter will align with the annual testing panel (Quarterly for one year until 4 consecutive quarters within limits, then Annual), but the VA may choose to test less frequently.

Upon request, retesting after remediation or other non‐routine testing will be performed at the request of the client point of contact. Should the quantity listed in the price schedule be exceeded, the COR will request a quote for review, and if accepted will be procured via Government Purchase Card (GPC). If services cannot be paid via GPC, the COR will submit a modification request to the Contracting Officer (CO). Approval from the CO is required before work may proceed.

Continuous Monitoring Equipment Service The PWA systems shall be properly calibrated and maintained to ensure accurate and reliable performance on an ongoing basis. The Flat Monthly Fee for each system shall include:

Sensor reading verification

Cellular data connection service

Training

Web based Data Management System The existing web‐based data management systems used for Legionella and SPS testing results will be used to collect, report, and store continuous monitoring water data. This existing web‐based data management system provides the following functions:

All information stored in the system is available 24/7 via password protected access

WMP‐related reports (including validation testing results, meeting minutes, verification reports, and service provider reports) can be stored and available for immediate access by all users

Customized charts, reports, views and data entry screens as requested

Management dashboards with industry benchmarking

Send text or email alerts for data that is outside of set parameters

Data collection via tablets and other hand‐held devices

Automated data collection via continuous monitoring equipment (equipment not included)

Exportable data to excel and other formats

The software platform shall meet the following minimum criteria:

Software‐as‐a‐Service (SaaS) enterprise‐class platform specialized for building water systems.

Capable of monitoring all sensor data from the potable water quality monitoring system.

Tables and graphs that can be plotted based on user selected time intervals and system parameters

Supports manual data entry via computer and mobile devices, automatic uploading of all water and microbiological test results, documentation of water management plans and activities, and automated sensor monitoring, as specified in VA directive 1061

Administrative functionality to control user access rights, and automated alert notifications

Data storage for a minimum of five years

Exportable data to excel and other formats

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The software platform shall meet the following Infrastructure Reliability and Information Security Management requirements:

The web application host shall provide a service level agreement (“SLA”) with a service commitment to a monthly uptime percentage of at least 99.95.

The web application shall be hosted at a datacenter compliant with FedRAMP requirements at the moderate impact level and in accordance with the Federal Cloud Computing Strategy.

The database shall be securely backed up hourly for disaster recovery purposes and provide a minimum durability of 99.999999999% and uptime of 99.999%.

The web applications shall be hosted as a Software‐as‐a‐Service (SaaS) data delivery model. This shall enable easy access to all data in a highly secure environment via the Internet using any internet connected device including personal computers and mobile devices.

The web application shall employ at a minimum TLS 1.2 with 128‐bit AES encryption and authentication.

The web application shall be delivered by way of a secure login‐protected environment with registered HTTPS security provisions.

The software platform shall meet the following minimum Application‐Level Security requirements:

A user account and password of adequate complexity shall be required for each individual user who accesses the system. New user accounts may only be created by administrators with the appropriate level of authorization.

Administrators shall have the ability to easily remove access from users no longer authorized to use the application.

All edits, deletions, or changes to existing data shall be logged with the date and time, user committing the change, and all original data shall be preserved. This audit trail shall be available to users with the appropriate level of access.

The web application shall have varying levels of access for data collectors, operators, site managers, water management team members, and administrators.

Users can be restricted by region or facility. A user restricted to a specific facility shall only be able to view data and information pertaining to that facility.

The software platform shall meet the following minimum Data Collection requirements:

Administrators shall be able to add, edit, or remove sample points in the system as needed.

A web page shall be available in the application for data collectors to enter test results.

The required testing frequency of each sample point can be configured as daily, weekly, or monthly. Alerts can be issued if required sample is missing.

The system shall allow data to easily be exported to a suitable format for offline use.

Time‐series charts shall be provided in real‐time for all data recorded in the system. Charts shall show alert limits and can be easily customized based on predefined specifications.

A daily summary report shall be generated in real‐time by the web application, indicating total number of samples tested by region and facility, total number of samples out of specification for chlorine and temperature, as well as chlorine range and average temperature for each facility.

The web application shall allow for the storage of electronic documents online. The storage capability shall include automated document versioning and all versions of all documents shall be retained.

The web application data shall be time‐stamped with the time it was entered as well as the time the user records it. Edits or changes to the data are logged so the original values can always be recovered.

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The web application shall have the ability to track customer service requests. Requests can be entered by plant personnel or by authorized contractors/vendors and tracked through the system until they are completed which makes it easy to marry equipment operations with equipment repair and maintenance.

Viewer permissions shall be determined based on the direction set forth by the client so those who have access can only see or do what they are authorized to see or do, and no one shall have a view into areas that are outside the scope of their roles and responsibilities.

The client may reclassify any properties, as and when required, from high risk to low risk or vice versa.

The software platform shall meet the following minimum Mobile requirements:

A mobile application shall be available for data entry on modern smartphones, including Apple IOS, Google Android, and Windows Phone operating systems.

Data can be entered, viewed, and edited on the mobile application by users with the appropriate level of access.

To enable resilient operation in the field, the mobile application shall operate with or without an active internet connection. In the absence of an internet connection, data shall be stored on the local device and synchronized with the remote server upon restoration of internet access.

The mobile application shall be capable of reading QR codes (barcoding) affixed to sample points to identify the sample and minimize data input errors. The web application shall be capable of printing QR codes for the associated sample points.

The software platform shall meet the following minimum Alerts requirements:

Alert levels can be set for each individual parameter at every sample point in the system. Alert levels can be easily adjusted at any time by users with the appropriate authorization.

Alerts shall be sent by email upon entry of any data exceeding predefined alert limits.

Each user account can be configured to receive alert emails by region or facility.

Alerts shall be clearly indicated when viewing data in the web application.

The web application shall incorporate a work order system that shall allow alerts to be prioritized and corrective actions to be logged. Users shall be able to view the alert and work order history by region or facility for which they are authorized, down to the individual sample points.

The software platform shall meet the following minimum Remote Data Acquisition requirements:

A system shall be provided to allow rapid deployment of remote sensors throughout the facility.

The sensors shall upload data at regular intervals to the remote servers and the data shall be easily accessible in the web application.

The system shall be capable of acquiring data from sensors with the following output types;

current, voltage, resistance, and pulse.

The data acquisition system shall be capable of both Ethernet and 3G cellular connectivity.

The data acquisition system shall send alerts by email when a sensor reading exceeds predefined alert limits.