S06_PWS_Legionella_SPS_Dental Water Sampling_SF_Revised 9Jul24.pdf

PERFORMANCE WORK STATEMENT

Legionella, SPS, and Dental Water Sampling/Maintenance

Sioux Falls VA Medical Center

OBJECTIVES:

The purpose of this contract is to procure services for collecting and analyzing water samples for Legionella, Dental Clinic water sampling and Sterile Processing Service Water Sampling.

This contract will adhere to the following standards for water testing in their respective areas.

VHA Directive 1061, “Prevention of Healthcare-Associated Legionella Disease and Scald Injury from Potable Water Distribution System.” “Infection Control Standards for VA Dental Clinics,” October 2015, and EPA Safe Drinking Water Act regulations in Dental Offices. VHA Directive 1061 (1) Prevention of Health Care-Associated Legionella Disease and Scald Injury from Water Systems and Infection Control Standards for VA Dental Clinics is provided as part of this requirement.

1. Legionella Sampling Requirements:

a. General Procedures for Legionella Sampling:

The contractor shall furnish all personnel, supervision, equipment, supplies, facilities, certifications, transportation, and resources necessary to perform Legionella water testing.

The contractor must furnish all sample collection equipment. Containers must be sterile, properly preserved, and promptly transported to the laboratory under strict chain of custody.

The contractor shall collect and analyze water samples from distal points (for example:

pure cold-water source, sinks and showers) and ice or water from ice machines at the Sioux Falls VA Health Medical Center (SFVAMC) campus included in the contract.

Specific distal point locations for sampling will be determined by the Contracting Officers Representative (COR) and/or the SFVAMC Point of Contact. The COR will generate a list of 20 sample locations in Building 1 for quarterly sampling and legionella testing. The COR will generate a list of 20 sample locations in Building 5 for quarterly sampling and legionella testing.

The Sioux Falls VA Medical Center is in the final stages of completion for the Hospice Cottage, Building 54, located on facility grounds. The expected occupation of the Hospice Cottage, Building 54, is June 2024. Beginning in the 3rd quarter of FY2024, the COR will generate a list of 20 sample locations in Building 54 for quarterly sampling and legionella testing.

The SFVAMC has three cooling towers which require quarterly Legionella testing while in operation.

1. Cooling Tower #1, North.

2. Cooling Tower #2, South.

3. Cooling Tower #3, Building 38.

The contractor shall travel to the Sioux Falls VA Medical Center four (4) times a year, collect 240 routine Legionella samples per year, collect up to 12 cooling tower samples per year, and provide 20 miscellaneous or non-routine Legionella samples.

Testing of the building’s hot and cold-water distribution system(s) for L. pneumophila must be performed quarterly (once per Federal Fiscal Year quarter, plus or minus 10 calendar days from the date of the last performance of regular quarterly service). Extensions may be granted for unforeseen conditions and for other factors outside of the contractor’s control.

Water samples must be taken from outlets on the hot water distribution system and outlets on the cold-water distribution system from each building for each quarterly testing cycle.

NOTE: “Outlets” are the points in the water distribution system where the end user comes in contact with the water (e.g., faucet, showers, and ice machines). Process to follow for water testing must be the following:

1. Water samples for bacterial culture will be taken at first “draw” to catch the water that comes out immediately from the outlet and will be 250 ml for bacteria culture.

2. The contractor will allow temperatures to reach maximum hot and maximum cold and document maximum temperature.

3. Contractor will then sample for chloramine level and pH.

Contractor is required to correctly label the sample and sample sites. Contractor is required to provide the finished report in English and ensure the reports accuracy prior to submission to owner. Contractor is required to provide definitions for any abbreviations used in reports.

Contractor is required to provide the following information in accordance with Healthcare Environment and Facilities Programs (HEPF) reporting for the persons sampling and for each laboratory utilized in analysis. Periodically, HEPF modifies the required information, the vendor shall comply and supply the required information.

1. Samplers Registration:

a. Last Name.

b. First Name.

c. Occupation.

d. Vendor Name.

e. Training source of sampler.

f. Date training completed.

g. Date competency evaluation.

h. Name of Person who performed competency evaluation.

i. List any restrictions.

2. Laboratory Registration:

a. Laboratory Name.

b. Address, City, State, Zip.

c. Telephone (with area or country code).

d. Fax.

e. Email.

f. Contract Number.

g. Contract type.

i. Contract.

ii. Purchase card.

iii. Purchase order.

h. Legionella proficiency.

i. Legionella.

• CDC Elite

• PHE-EQA

i. Laboratory Accreditation.

i. Environmental.

• NELAP.

• A2LA.

• ACLASS.

• L-A-B.

• PJLA.

• EMLAP.

• OTHER.

j. VA Certification Verifier.

k. Date Certifications Verified.

l. Lab Legionella Limit Detection (CFU/ml format).

Non-routine sampling (outside of the quarterly sampling) may be conducted as needed.

The Sioux Falls VA Medical Center may require up to 20 additional Legionella test per year.

The Sioux Falls VA Medical Center staff shall collect the samples. The contractor shall provide the supplies and shipping.

The specific sampling location and type of sample (e.g., hot water or cold water) will be specified by the COR and/or Health Care System Point of Contact. Specific distal points sampled will vary per quarter, so communication with the Health Care System Point of Contact will be required before the round of sampling each quarter or before non-routine sampling in order to ensure that the contractor knows the locations of sampling.

b. Sample Collection, Storage, and Transferring of Analysis:

Samples will be collected, stored, and transferred to the Environmental Legionella Isolation Techniques Evaluation (ELITE) laboratory. For routine sampling, water samples shall be 250 ml. Each water sample will be collected in a sterile, unused, High-Density Polyethylene (HDPE) plastic leak-proof container provided by the testing laboratory. The following parameters will be measured and logged with each water sample that is collected: water temperature upon reaching a stable temperature, level of residual biocide and type of biocide measured, and pH. Samples will be stored and transferred for analysis in a manner that will maintain the integrity of the samples. Samples will be secured to prevent cross-contamination. Samples need to arrive at the testing laboratory within the time frame defined by the Environmental Legionella Isolation Techniques Evaluation (ELITE) laboratory.

c. Sample Analysis and Reporting:

The testing laboratory processing the water samples for Legionella must be certified by 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 limit of detection must be < = 1 CFU/ml. The full 250 ml volume of potable water must be concentrated for routine quarterly testing. The full 1000 ml volume of potable water must be concentrated for non-routine testing. The testing laboratory must retain samples that test positive for Legionella for 30 calendar days and must release them to the healthcare system if requested. Information about ELITE certified laboratories can be found at https://wwwn.cdc.gov/Elite/Public/MemberList.aspx. The testing laboratory must also be able to determine if the Legionella detected in environmental samples is the species Legionella pneumophila and whether it is serogroup 1. Quantify L. pneumophila and identify the presence or absence of other Legionella species.

NOTE: rapid testing method, such as polymerase chain reaction (PCR) and direct fluorescent antibody (DFA) are not permitted.

In addition to the CDC ELITE certification, the laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body, such as EMLAP, NELAP, etc. Proof of certification must be provided before acceptance of contract.

Provide all sample analysis reports via e-mail to COR and Health Care System Point of Contact (POC). Notification of any positive sampling results will be made within two (2) working days of making this determination. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations and conditions, including the specific outlet temperature of water at the time the sample was collected, pH, biocide residual levels, method detection limits, and a description of test methodology.

The final report submitted to the Point of Contact and/or COR shall be in Excel Spreadsheet format. Periodically, HEPF modifies the required information, the vendor shall comply and supply the required information.

1. Sample ID.

2. Sample date.

3. Floor number.

4. Room number.

5. Sample source.

a. Faucet.

b. Shower.

c. Sink.

d. Etc.

https://wwwn.cdc.gov/Elite/Public/MemberList.aspx

6. Sample type.

a. Hot water.

b. Cold water.

7. Sample volume in milliliters (ml).

8. Water temperature in degrees Fahrenheit.

9. Biocide type.

10. Biocide level.

11. pH.

12. Name of individual taking the sample.

13. Date sample sent to laboratory.

14. Date report sent to POC and COR.

15. Was Legionella detected in the sample.

a. Yes or no.

b. If yes, provide species and serogroup with concentrations in CFU/ml.

16. Name of the laboratory used for Legionella testing.

17. Lab sample Id.

18. Was sample stored for future molecular typing.

a. Yes or no.

b. If yes, what is the storage end date.

Sample analysis reports must be provided within 15 calendar days of the lab receiving the samples. If the 15th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day.

The testing laboratory shall have qualified technical support staff for consultation relative to water sample collection, testing, and interpretation of results.

Dental Waterline Sampling

OBJECTIVES:

The purpose of this contract is to procure services for collecting and analyzing water samples to verify compliance with “Infection Control Standards for VA Dental Clinics,” 21 October 2013, and EPA Safe Drinking Water Act regulations in Dental Offices in the Sioux Falls VA (SFVA) Health Care System. A summary of expected sample collection and analysis activities will be provided.

VHA Directive 1061 and “Infection Control Standards for VA Dental Clinics” is provided as part of this requirement.

Sampling is required on a quarterly basis for waterlines in the Dental clinic. 40 samples need to be taken per quarter. The 40 samples will be divided over the first two separate months of each quarter, 20 each month, so that it will have the least amount of disruption to dental clinic workload. The third month of each quarter will be reserved for any retesting that may be required.

Non-routine sampling (outside of the quarterly sampling) may be conducted as needed, up to 10% of total samples taken annually. If sampling over this amount is needed by the healthcare system, the contractor will provide a fixed price for sampling equipment and analysis. For non-routine sampling bottles and supplies must be provided by the contractor and received by the requesting Dental Clinic within two (2) business days of being notified of the need to sample.

The contractor will furnish 40 sterile bottles and a minimum of four (4) ice packs that are appropriate, per industry standard, for the analysis at the beginning of each quarter, properly preserved and promptly transported to the SFVA Dental Clinic. The contractor will furnish appropriate shipping containers and supplies for the transport of samples to the laboratory. The bottles will be marked to indicate what facility they are supplied to and a unique identifying number for that facility and the sample. Comprehensive instructions on how samples will be collected, preserved, and transported to the laboratory for analysis will be provided to the Sioux Falls VA Dental Staff, per contract requirements. The laboratory will follow strict chain of custody procedures, per industry standard, as required by lab certification upon receipt of the samples from the facilities.

The Contractor will provide all sample analysis reports via email to the COR and the Health Care System Point of Contact within ten (10) calendar days of receiving the samples. If the 10th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day. Notification of any positive sampling results will be made within two (2) working days of making the determination. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, method detection limits, and a description of test methodology.

The testing laboratory shall have qualified technical support staff for consultation relative to water sample collection, testing, and interpretation of results.

Sterile Processing Service (SPS)

1. Contractor shall provide:

a. The contractor shall provide critical water system sampling services, per the quality requirements within SPS, defined in the Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report ST108:2023 “Water for the Reprocessing of Medical Devices”.

This document not only defines the parameters to be monitored but also outline the frequency of quality testing and limits for the noted contaminants in utility water and critical water.

b. The contractor’s personnel, while on VA property, shall adhere to all requirements and regulations that govern the VA Health Care System and its property.

c. Services shall be performed by contractor on site during normal business hours Monday through Friday 7:30 am to 4:30 pm, excluding Federal Holidays, unless otherwise authorized by the VA POC. All Samples shall be collected on the 1st of every month unless it falls on a holiday, or weekend then it would be collected on the next normal business day.

2. Reporting:

a. The contractor shall provide all sample reports via email to the VA Technical Representative within ten calendar days of receiving the samples. If the tenth day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day. Notification of any abnormal results will be made within two calendar days of making the determination.

b. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, method detection limits, and a description of test methodology.

c. The testing laboratory shall have a qualified technical support staff for consultation relative to water sample collection, testing, and interpretation of results.

3. Sampling Requirements:

a. The Sterile Processing Service is located at the Sioux Falls VA Health Care system at 2501 W 22nd Street, Sioux Falls, SD 57105.

Frequency for water quality monitoring at water generation system:

Water Quality Measurement Type of Testing

Routine Monitoring

Sampling Site

Minimum Frequency of Testing*

Utility Water Critical Water pH pH meter** or Colorimetric dipsticks (sample tested within 15 minutes)

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly

Conductivity Conductivity meter** or Colorimetric dipsticks

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly

Total Alkalinity Colorimetric dipsticks Alkalinity test kit **

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly

Total Hardness Determination of ppm as CaCO3 by Colorimetric dipsticks, Titration kit**, or Handheld meter**

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly

Bacteria Heterotrophic plate count (see Annex H)

Each location of point-of-use in department

N/A Monthly

Endotoxin LAL test (see Annex H)

Each location of point-of-use in department

N/A Monthly

Description of Service Frequency

PH 12 per year

Total Alkalinity 12 per year

Total Hardness 12 per year

Bacteria 12 per year

Endotoxin 12 per year

**NOTE- If results are bad, additional tests will be required until water is in range**

Frequency for water quality monitoring at point-of-water-use:

Water Quality Measurement Type of Testing

Routine Monitoring

Sampling Site

Minimum Frequency of Testing*

Utility Water Critical Water

Steam pH pH meter** or Colorimetric dipsticks (sample tested within 15 minutes)

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly N/A

Conductivity Conductivity meter** or Colorimetric dipsticks

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly N/A

Total Alkalinity Colorimetric dipsticks Alkalinity test kit **

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly N/A

Total Hardness Determination of ppm as CaCO3 by Colorimetric dipsticks, Titration kit**, or Handheld meter**

At the point the distribution loop enters the processing area or first POU on the distribution loop

N/A Monthly N/A

Bacteria Heterotrophic plate count (see Annex H)

Each location of point-of-use in department

N/A Monthly N/A

Endotoxin LAL test (see Annex H)

Each location of point-of-use in department

N/A Monthly N/A

Description of Service Frequency

PH 24 per year

Conductivity 24 per year

Total Alkalinity 24 per year

Total Hardness 24 per year

Bacteria 24 per year

Endotoxin 24 per year

**NOTE- If results are bad, additional tests will be required until water is in range**

Tests to be performed by the contractor:

Test location for water generation system (Located in room E02 building 5):

• Water generation system pH Monthly

• Water generation system Total Alkalinity Monthly

• Water generation system Total hardness Monthly

• Water generation system Bacteria Monthly

• Water generation system Endotoxin Monthly

Testing location for Point of water use (Located in SPS E08-5 building 5):

• Point of water use pH Monthly

• Point of water use conductivity Monthly

• Point of water use Total Alkalinity Monthly

• Point of water use Total Hardness Monthly

• Point of water use Bacteria Monthly

• Point of water use Endotoxin Monthly

Contractor Provided:

• Contractor shall provide all sample collection devices.

• Contractor shall provide written report that states actual results and if limits are within correct range as indicated in the Department of Veterans Affairs Memorandum dated August 28th, 2020, required critical water system testing and reporting for sterile processing services.