SOW Water Quality Testing With Web Based Platform.docx

Performance Work Statement Western States Network Consortium VISNs 17, 19, 20, 21 Water Quality Testing

B.1 DESCRIPTION OF AGREEMENT

Under this agreement, the IDIQ holder shall provide water sampling/testing of designated points, as indicated, for: potable water, utility water, steam, and critical water points. The Contractor shall provide observed parameters and analysis for legionella, pH, conductivity, total alkalinity, total hardness, bacteria, water temperature, endotoxin, and residual biocide for samples taken. Testing quantities will be specified by each individual task order and will occur on reoccurring intervals as defined by individual facilities. Non-routine and emergent sampling may be conducted as needed. Contractor shall provide an option for expedited reporting method for retests. Contractor shall provide an option for equipment for automatic daily trending and monitoring of water conductivity. Contractor shall provide options for water safety and water collection training. Contractor shall provide remote support on water management questions as needed. Contractor shall provide an option for an established functioning cloud-based reporting & analytics platform. Appropriate sample containers of correct material, content, and capacity and shipping packaging shall be included based on analysis specified in scope of work.

The contractor must be familiar with the requirements specified within the Statement of Work, and the VA requirements, national standards, regulations, and policies listed below:

1. VHA Directive 1061 Prevention of Health Care-Associated Legionella Disease and Scald Injury from Water Systems

2. Advancement of Medical Instrumentation (AAMI) ST108 (2023)

3. VHA Directive 1116(2) “Management of Critical and Semi-Critical Reusable Medical Devices”

4. Infection Control Standards for VA Dental Clinics, May 9, 2024

5. ASHRAE Guideline 12-2000, Standard Minimizing the Risk of Legionellosis Associated with

· Building Water Systems for Legionella (reference CDC website)

· http://www.cdc.gov/legionella/about/prevention.html

6. ANSI/ASHRAE Standard 188 Legionellosis: Risk Management for Building Water Systems

7. CDC Toolkit: Developing a Water Management Program to Reduce Legionella Growth & Spread in Buildings

8. CMS Requirement to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires’ Disease (LD)

9. OSHA Technical Manual – Section III: Chapter 7

· https://www.osha.gov/dts/osta/otm/otm_iii/otm_iii_7.html

10. OSHA Legionellosis (Legionnaire’s Disease and Pontiac Fever) Safety and Health Topics page (S&HTP)

11. Safe Drinking Water Act (SDWA)

· http://water.epa.gov/lawsregs/rulesregs/sdwa/index.cfm

12. CTI Guidelines WTB-148, Legionellosis Guideline: Best practices for Control of Legionella

· http://www.cti.org/downloads/WTP-148.pdf

13. Joint Commission Environment of Care Standards – EC 02.05.01

These points include VA-owned buildings in which patients, residents, or visitors stay overnight such as but not limited to, acute care facilities, Community Living Centers, domiciliary, Fisher Houses and temporary lodging facilities (“hoptels”); VA-owned buildings where staff are required to sleep overnight as part of their job; Outdoor non-potable, aerosol-generating water systems such as, but not limited to, cooling towers and irrigation systems; Sterile Processing Services; Dental Clinics, and Pathology & Laboratory Medicine Laboratory Services. Collections will be taken from the below locations:

Water generation locations;

Point of water use locations;

Water chillers and cooling tower sources.

The contractor(s) shall schedule time for initial meetings/walk throughs for risk assessments, and to establish requirements and locations at each facility per individual task orders. These initial meetings/ walk-throughs shall be part of the services provided with no additional charges to individual facilities.

B.2 OBLIGATION OF FUNDS

This IDIQ does not obligate any funds. The Government is only obligated to the extent of authorized Task Orders issued under this IDIQ.

B.3 PRICE -COST SCHEDULE

The Contractor shall provide pricing for each orderable item per

B.4 TERM OF IDIQ

This IDIQ is established for a period of five years from the date of award/effective date listed in block 3 of the SF1449. The Government shall conduct an annual review of the established IDIQ. Upon completion of the annual review, a determination will be made whether or not it is in the best interest of the Government to continue with performance of this IDIQ.

B.5 AUTHORIZED USERS

WSNC COs (NCO 17, 19, 20, 21, or 22) and Government Purchase Card Holders are the only authorized users to place orders under this IDIQ. IDIQ holders shall not accept or perform any purported order that does not contain an order number.

B.6 ORDERING

TOs will be placed against this IDIQ using official email messages and Electronic Data Interchange (EDI). The terms and conditions included in this IDIQ apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this IDIQ and the Contractor’s invoice, the provisions of this IDIQ will take precedence, unless TO variation has been otherwise authorized by the IDIQ.

B.7 PURCHASE LIMITATIONS

Individual TOs may not exceed XXX

B.8 PERFORMANCE WORK STATEMENT

8.1 LEGIONELLA SAMPLING AND ANALYSIS

1. Each VA Facility under this IDIQ shall have the option of VA staff conducting sample collection, or Contractor staff. The Contractor shall provide all collection materials/containers and packaging. The containers shall meet quality environmental compliance as prescribed by Title 21 Code of Federal Regulation (CFR) Part 820.

2. For VA Facilities opting for VA Staff to conduct collection, then the Contractor shall provide chain of custody paperwork, 250ml water sampling containers (bottles), shipping boxes and packages (ULIN S-18943 type along with bubble wrap bags), “blue ice” or other methods to maintain appropriate sample temperatures during shipment, and pre-paid shipping labels for FedEx or UPS overnight service. It is anticipated that sampling supplies will be required every three months. The VA will not stock 12 months’ worth of sampling supplies.

3. For VA Facilities opting for full service, then the Contractor will provide the labor and materials to collect samples for Legionella detection during each quarter of the Federal fiscal year and in accordance with VHA Directive 1061 “Prevention of Healthcare-Associated Legionella Disease and Scald Injury from Potable Water Distribution Systems”. Samples shall be collected at locations and intervals indicated by individual facilities. When request by COR or representative is generated, contractor shall perform sampling within two (2) business days of notification.

a. 20 samples per VA owned building containing overnight stays

b. 2 samples at each chiller and 1 sample at each cooling tower basin.

4. Instruments must be used in accordance with manufactures sampling procedures. Must have proof of current annual NIST – Traceable Calibration certificate from a certified institution. A NIST certified buffer solution must be used for in field pH calibration. The instrument must be in operable condition without visual evidence of damage and produce repeatable results with any one sample. The instrument must not be displaying any error indicators such as low battery.

5. Samples must be taken at VHA approved sampling locations. In field calibration and general use of instruments must be performed in accordance with manufactures directions. Measure the pH and chlorine in a triple rinsed container using water from the sampling source outlet prior to final measurement. The VHA representative will evaluate written information for accuracy, legibility, and sign their name at the bottom of each page of the Chain of Custody Record, stating “Witnessed by: VHA Representatives Signature”

6. Sampling Process:

a. Step 1: Collect Water Sample for Legionella Testing

i. Collect water volume of 250 ml or more (e.g., if PCR negative screen will be used), in sterile, screw top bottle.

ii. Water sample must be first draw (i.e., immediately after opening the tap).

iii. For faucets, open cold-water side for cold water sample. Open the hot water side for hot water sample (if no mixing valve) or mixed sample (if mixing valve present).

iv. If required by lab, ensure that a neutralizing agent is used.

v. Refrigerate samples according to laboratory requirements.

vi. Ship samples to testing lab promptly.

b. Step 2: Collect Another Water Sample, Conduct Biocide Testing.

i. After the Legionella water sample is taken, open the same tap (hot or cold) and collect the next immediate sample (volume determined per testing equipment instructions).

ii. Leave water running to begin temperature equilibrium.

Equipment/Methods: Testing equipment that utilizes DPD, ORP, or Amperometric titration. Test strips should only be used in conjunction with another, approved, method.

iii. Samples should be tested on-site immediately after taking the sample (can use same container to test each sample, emptying out and triple rinse the container between tests).

c. Step 3: Collect Another Water Sample, Conduct Temperature and pH Testing

i. After taking the outlet’s biocide reading, open the same tap (hot or cold) and flow the water for at least 60 seconds.

ii. Collect the water sample after at least 60 seconds has passed (volume determined by testing equipment instructions).

iii. Take the water temperature within 10 seconds of collecting the sample. Equipment/Method: Immersion thermometer; digital recommended, however analog can be used. Infrared must not be used.

iv. After taking the temperature reading, use the same sample to take the pH reading.

Equipment/Method: An electronic pH meter. Test strips are not to be used.

7. The Contractor shall submit a sampling schedule broken down for each quarter showing dates (month and day) for each required test for Contracting Officer’s Representative (COR) approval.

8. Upon approval of the Contractor’s sampling schedule, the Contractor shall coordinate service activities with locations, dates, and times with the COR, consistent with the locations identified in the Inventory.

9. At the time that each sample is taken, the water temperature, pH, and level of residual biocide shall be recorded.

10. All samples taken will be identified by location, i.e. Building # , Room #, hot water/cold water, and fixture type (shower, sink, bath, drinking fountain, ice machine). Contractor will use a Chain of Custody form that is recognized by the Testing Laboratory service and the VAMC as an aid in tracking the sample.

11. Proper chain of custody forms will be completed by the contractor during the collection of samples. Once water samples are collected, they must be delivered to the analytical laboratory within 30 hours. To ensure integrity, sample collections shall be done by the contractor and laboratory testing shall be conducted by delegated laboratory facility or subcontractor. Samples must be delivered to the testing laboratory per the CDC and VHA Directive 1061 for sample collection. The CDC Method for Legionella culturing known as “Procedures for the Recovery of Legionella from the Environment” will be used for the sample analysis. Other methods of Legionella analysis are prohibited. All aspects of water sampling will be held in strict confidence and are to be discussed only with the VA COR and staff he/she authorizes.

8.2 LEGIONELLA TESTING REQUIREMENTS AND LABORATORY QUALIFICATIONS

1. QUALIFICATIONS AND TESTING LABORATORY DUTIES AND PROCEDURES: In accordance with VHA Directive 1061-4, the laboratory processing the water samples for Legionella must be certified by the CDC ELITE program as proficient at performing the culture of Legionella species from environmental samples. The testing laboratory will utilize the “CDC Method” for Legionella culturing known as “Procedures for the Recovery of Legionella from the Environment” this method includes the “Presumptive Phase” and “Confirmatory Phase” as described below:

i. The “Presumptive Phase” will be used for potable water and non-potable water. Potable waters will be filtered and plated on Buffered Charcoal Yeast Extract (BCYE) agar for primary culturing of Legionella. Non-potable water requires an acid buffer treatment prior to plating on the BCYE. Due to the overall high bacterial count present in the non-potable water, this step is used to reduce the number of these non-legionella bacteria from the water before culturing.

ii. After the “Presumptive Phase”, the “Confirmatory Phase” will be conducted. All colonies that do not grow on the BCYE agar plates will be analyzed using the “Legionella Latex Test”. This test is a serology method used to identify Legionella colonies by its serotype. This test will determine Legionella pneumophila serogroup 1 and serogroup 2-14. It will also identify the presence of non-pneumophila Legionella bacteria, or "other Legionella species" including Legionella anisa, Legionella bozemanii, Legionella dumoffii, Legionella gormanii, Legionella jordanis, Legionella longbeachae 1 and 2, and Legionella micdadei.

iii. Upon completion of the Legionella culturing and enumeration, the original results will be emailed to the contractor for immediate interpretation. The testing laboratory shall submit copies of the reports tests promptly and directly to the contractor. All reports shall contain at least the following information:

1. Testing Laboratory Name and Address

2. Project Name/Lab Request Number

3. ELITE or NELAC Accreditation Number

4. Sample Receipt Date

5. Report Date

6. Location of Sampling (i.e., building and room numbers)

7. Name and Signature of Laboratory Director or Manager

8. Copy of Chain of Custody Form

9. Sample results in colony forming units per milliliter (cfu/ml)

a. Water temperature, biocide residual level, and pH for each sample collected

10. Method of Analysis

2. WATER SAMPLE RESULT REPORTING AND TRACKING

i. All positive sample result reports will be sent to the VA via email by contractor within 24 hours of the receipt of positive sample results from lab. A list of email recipients will be provided.

ii. Attached to email from contractor will be a recommended course of mitigation action.

iii. All sampling results will be tracked on a spreadsheet approved by the COR. The spreadsheet must include “L” results, free chlorine residual, pH, water temperature, date. Mitigation date, locations (room number) and retesting when applicable.

8.3 RE-TEST REQUIREMENTS

1. At request form the COR, the Contractor shall provide re-testing of those components to verify that the mitigating actions resolved the detection.

2. Re-testing will be at the COR’s direction.

3. The Contractor shall include a provision for individual re-tests per performance year in the quantities indicated on this this CLIN. This pricing should include travel to collect samples if the facility chose the option for contractor to collect all samples and shipping costs for lab analysis.

4. Contractor shall provide an option for an expedited method of testing.

8.4 WATER TESTING FOR THE PROCESSING OF MEDICAL DEVICES

The contractor is required to follow all the guidelines set out in AAMI ST108. Categories of Water defined by AAMI ST108 are Utility Water, Critical Water, and Steam. Table 2 in AAMI ST-108 governs these categories and performance qualification levels of water quality for medical device processing. Table 5 in AAMI- ST-108 governs the frequency for water quality monitoring. Table 6 in AAMI ST-108 governs the frequency for water quality monitoring at point-of-water-use.

The contractor’s responsibility of this contract includes:

1. Provide all labor, materials, tools, equipment, applicable state licenses and permits to accomplish this scope. Task order recipients will have the option to collect water themselves or opt for the contractor to collect samples.

1. Provide all testing requirements as outlined by AAMI ST-108, WATER FOR THE PROCESSING OF MEDICAL DEVICES.

1. Provide a fully qualified Laboratory for processing of water samples to meet all metrics from AAMI ST-108-2023. Ensure all laboratory certificates, credentials and capabilities are provided to VA COR/POC.

1. Provide critical, utility, and steam samples according to AAMI ST-108.

1. Provide a consolidated monthly report of all sample locations, results, parameters on a single report within 10-14 consecutive days after samples are received by the laboratory.

1. Provide immediate notification of any positive samples over the bacteria and endotoxin threshold per AAMI ST 108.

1. Provide a tracking mechanism on balance of all tests, per Task Order, including Emergency / On-call tests for any locations that require re-testing per request of VA.

*UN-INTENTIONAL OR ACCIDENTAL CONTAMINATION OF THE CRITICAL WATER SAMPLES OCCURS WHEN THE TESTER DOES NOT MAINTAIN PROPER PPE, FLUSHING OF TEST PORT, CLEANING OF SITE, OR USE OF GLOVES. VA STAFF HAS RIGHT TO HAVE TESTER RE-TAKE A SAMPLE IF HE/SHE BELIEVES THE SAMPLE WAS TAKEN WITHOUT ADHERANCE TO RIGID PPE OR SAMPLING DISCIPLINE.

1. Ensure contractor staff adhere to all PPE requirements when testing in PPE required areas.

1. Ensure contractor staff conducts a thorough test-location wipe down with alcohol wipes and utilizes latex or vinyl gloves to avoid accidental contamination of sample.

1. Ensure contractor staff conducts flushing of testing location valves, sample ports, sinks, sprayers…etc., to avoid accidental contamination.

1. Enforce a strict chain of custody of sampling so that samples are secured and shipped by one dedicated technician.

14. Contractor to immediately notify VA of any breach in chain of custody or shipping issues that would render the samples un-usable. Contractor to coordinate with VA on providing re-tests.

15. All work to be done during normal business hours.

16. The contractor shall verify all existing utility installations and take appropriate action prior to working in the vicinity of utility services (electrical, plumbing, HVAC, etc.).

8.5 DENTAL SERVICES

Per the Environmental Protection Agency (EPA), The Centers for Disease Control (CDC), and American Dental Association (ADA), dental chairs are to be tested quarterly for total colony forming units of heterotrophic water bacteria per milliliter of water count (HPC), ensuring no chair exceeds 200 colony forming units (cfu) per milliliter of water. These are to be done on a quarterly basis with individual facilities having the option to for contractor to collect samples or facility personnel to perform collection.

8.6 REPORTING & DELIVERABLES

If measurements or visual inspections detect any existing or potential problems, they shall be discussed with the COR before the Contractor leaves the site. Each individual facility will have the option to choose the testing services under this scope that best meet their facility’s requirements. The Contractor shall submit separate PDF reports for each of the above type tests with the information and analysis required following each testing event in this scope to the Facility COR/POC. The reports shall include test methodologies, test results, and the parameters defined in this Statement of Work. The water testing results/reports shall be provided within 10-14 consecutive days of sample receipt by laboratory and emailed to the designated facility COR/point of contact. Failure to meet this requirement would constitute grounds for contract cancellation due to the safety issues delays could cause.

8.7 WEB-BASED DATA MANAGEMENT PROGRAM

The Contractor shall provide an optional web-based water data management program with Management Dashboards, Organizational and Site Management, Key Performance Indicator Management and Tracking, and action item trackers.

This web-based program shall be able to;

Store all program information such as process flow diagrams, system analyses, program controls summaries, water team meeting notes.

Provide data verification for quality assurance of water management to include data collection forms for operators and vendors, notifications and alerts, real-time water quality monitoring, and verification and corrective action logs.

Provide validation through testing dashboards, testing reports/results, schedules and logs, and response guidance.

8.8 QUALIFICATIONS

The contractor selected to perform this work must be an independent provider of water management services engaged in the development and ongoing management of facility and corporate water management programs. To be deemed “independent” and thus avoid commercial conflict of interest, neither the prime contractor, nor any partners, subcontractors nor subsidiary companies may sell treatment chemicals, disinfection devices or remediation services. The sale of water testing services and diagnostic equipment related to determining the safety and quality of the water does not void independence.

The laboratory must have a certificate from the Centers for Disease Control and Prevention (CDC) Environmental Legionella Isolation Techniques Evaluation (ELITE) Program as proficient at performing the culture of Legionella from environmental samples. The laboratory must also have environmental microbiology accreditation by a nationally recognized accrediting body (e.g., EMLAP, NELAP).

8.8 INFORMATION SECURITY

The C&A requirements do not apply, and a Security Accreditation Package is not required.

8.9 RECORDS MANAGEMENT

A. Applicability

This applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records,

2. does not include personal materials,

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract, and

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. The Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created while performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the IDIQ. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the IDIQ. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

8. The 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 from public disclosure by an exemption to the Freedom of Information Act.

9. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

10. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flow down of requirements to subcontractors.

1. The Contractor shall incorporate the substance of section 8.9, its terms, and requirements including this paragraph, in all subcontracts under this IDIQ, and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

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