Appendix C.pdf

February 16, 2021 VHA DIRECTIVE 1061(4)

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APPENDIX C

CLINICAL AND ENVIRONMENTAL VALIDATION OF ENGINEERING CONTROLS

FOR PREVENTION OF LEGIONELLA GROWTH IN BUILDING POTABLE WATER

SYSTEMS

1. BACKGROUND

Validation focuses on collecting and evaluating information to determine if the engineering control measures (e.g., water temperature, biocide levels) are effectively controlling Legionella growth in a building’s potable water distribution system(s). The two validation methods for Veterans Health Administration (VHA) buildings subject to this directive (see paragraph 1 in the body of this directive) are clinical surveillance testing and environmental water testing. Validation procedures are to be included in the building health care-associated (HCA) Legionella disease (LD) prevention plan.

Requirements for the two methods are described in paragraphs 2 and 3 of this appendix, along with guidance on interpretation of results and remedial actions.

Summary flow charts depicting the key concepts for environmental validation and clinical validation are included at the end of this appendix. NOTE: While environmental water testing is listed first in this appendix for logistical reasons, it is not meant to imply priority or importance over the clinical surveillance for disease. Furthermore, both the clinical and environmental validation processes in this appendix are intended to assess the effectiveness of the routine implementation of engineering controls and may not include all practices necessary after a case of HCA LD or in an outbreak situation.

2. ENVIRONMENTAL VALIDATION

For this appendix, environmental validation is the process of periodically testing the building’s potable water distribution system(s) to determine if the engineering controls are successfully inhibiting growth of Legionella. Therefore, the primary use of the findings from this routine environmental testing is to assess if adjustments to the implementation of the engineering controls are necessary. However, since Legionella in the water system of a health care building may be a risk for building occupants, this section provides overarching requirements and recommendations for both assessment of engineering controls and remedial actions. NOTE: See paragraph 5 of this appendix for a summary flow chart for interpreting routine water testing results.

a. Quarterly Testing Requirement. Testing of the building’s water distribution system(s) for Legionella must be performed at least quarterly (once per Federal Fiscal Year quarter).

(1) At least 20 water samples (first draw) from water outlets from each building must be tested for Legionella for each quarterly testing cycle. After taking the Legionella water sample, take additional samples at the same outlet to test and document water temperature, pH and level of biocide. NOTE: Department of Veterans Affairs (VA) medical facilities may choose to conduct testing of additional outlets or areas beyond the required 20 outlets (e.g., water tanks, distribution piping). This additional testing

APPENDIX C

C-2 must be determined based on local conditions (e.g., size of building, patient population risk factors, known history of HCA LD, suspicion for recent or current HCA LD occurrence, previous environmental testing results, unique aspects of the VA medical facility’s infrastructure and ability to implement engineering controls to prevent Legionella growth in the building water distribution systems). Additional information on how to test water samples is available at the Water Safety Management and Legionella Resources website at http://vaww.hefp.va.gov/healthcare-engineering/water-safety-management-legionella. This is an internal VA website that is not available to the public.

The types of water samples to be collected for testing are as follows:

(a) At least two of the 20 samples must be from an ice machine or other pure cold-water source. NOTE: Ice machines have been implicated as a source for HCA LD in outbreak investigations reported in the literature. Ensure all ice machines used for patient or resident care are properly maintained and cleaned on a routine basis.

(b) At least two of the 20 samples must be from a pure hot water source (i.e., no mixing valve present), if such water outlets are available.

(c) For the remainder of the samples, where a mixing valve is in place at the outlet, the first draw sample is considered a mixed hot/cold (“mixed”) water sample. If no mixing valve is in place at the outlet, take the first draw sample from either the hot or cold side. The distribution of hot, cold and mixed water samples from a building for each quarterly testing cycle is dependent on the types of outlets and mixing valves present.

Representation from each type of water sample available (hot, cold and mixed) must be attempted each quarter based on the building risk assessment, past testing results and deliberations of the Facility Water Safety Committee to determine where validation testing is most needed.

(d) For buildings with 20 or fewer sample locations, testing of 50% of the potential sample locations can be done each quarter instead of all 20 samples each quarter. The location of the samples must be varied during each sampling cycle, as should the types of water samples taken (hot, cold and mixed) based on deliberations of the Facility Water Safety Committee and validation needs.

(2) For routine water testing, collection of swab samples is not required, although a VA medical facility may choose to collect swab samples in addition to water samples.

Swab samples alone do not meet the requirement of this directive.

b. Laboratory Requirements. Once collected, samples are to be processed for Legionella detection by a testing laboratory with experience in microbial testing of potable water. In addition to culture methodology for Legionella detection, VA medical facilities may choose to first have water samples tested by polymerase chain reaction (PCR) to screen for negative samples (see paragraph 2.c. of this Appendix for more details). The testing laboratory is to be selected, with input from the Facility Water Safety Committee, using the following criteria:

(1) Laboratories that process water samples for microbiological testing must:

http://vaww.hefp.va.gov/healthcare-engineering/water-safety-management-legionella

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(a) Be accredited by a recognized regional, national or international accrediting body as follows:

1. In accordance with a laboratory accreditation standard (e.g., ISO/IEC 17025:

2017, General Requirements for the Competence of Testing and Calibration Laboratories). Examples of such accrediting bodies include the National Environmental Laboratory Accreditation Program (NELAP); the American Association for Laboratory Accreditation (A2LA); and the Environmental Microbiology Laboratory Accreditation Program (EMLAP).

2. Include Legionella testing method(s) that will be used on facility water samples in the laboratory’s scope of accreditation, as documented on the laboratory’s accreditation certificate.

(b) Demonstrate proficiency by the Centers for Disease Control and Prevention (CDC) Environmental Legionella Isolation Techniques Evaluation (ELITE) program or the Public Health England (PHE) Legionella External Quality Assessment (EQA) scheme at performing the culture of Legionella from environmental samples. Information about the CDC ELITE program and a listing of laboratories that are ELITE members can be found at https://wwwn.cdc.gov/elite/public/elitehome.aspx. If PCR will be used in addition to culture, then the laboratory also must demonstrate proficiency at PCR detection of Legionella from environmental samples by the CDC-recognized lab conducting proficiency testing (currently the Wisconsin State Laboratory of Hygiene (WSLH)) or by the PHE EQA Legionella molecular scheme. NOTE: The method(s) used by the laboratory on the samples that the VA medical facility uses to determine Legionella positivity is to be the same method(s) used by the laboratory for proficiency testing.

(c) Be able to determine if the Legionella detected by culture in environmental samples is the species Legionella pneumophila and, if so, if it is L. pneumophila serogroup 1.

(2) If there is a possibility that the VA medical facility will use molecular typing to characterize environmental Legionella isolates (e.g., for potential comparison to clinical Legionella isolates during a case investigation), then the VA medical facility must make arrangements with the testing laboratory for storage of the environmental isolate(s) at least temporarily.

(3) Prior to environmental testing, the selected laboratory must be consulted regarding requirements and recommendations on sample collection and shipping.

Protocols recommended by the laboratory must be in alignment with the requirements in this directive. NOTE: The selected laboratory must be informed if biocides (e.g., chlorine) have been added to the building’s potable water distribution systems to determine if samples must be processed to neutralize the biocide prior to being sent out for testing.

https://wwwn.cdc.gov/elite/public/elitehome.aspx

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c. Optional Use of Legionella PCR to Screen Water Samples (“PCR Negative screen”). The PCR method detects the presence of Legionella genetic material in water samples. Detection of Legionella genetic material indicates the presence of Legionella in the water sample, though the method may not be able to determine reliably if the Legionella are alive or dead. Therefore, VA medical facilities may opt to use Legionella PCR testing to first determine if water samples are negative for the detection of Legionella genetic material. NOTE: The PCR method utilized must be able to detect the genus Legionella, not just L. pneumophila. If a water sample is negative by PCR, then further processing of that sample by culture is not required and the sample can be considered “negative for Legionella detection”. If the sample is positive by Legionella PCR or if the laboratory reports the PCR result as indeterminate, then that same water sample must be processed for culture detection of Legionella to determine if living Legionella are present; the culture result is then used to determine if the sample is Legionella-positive or not. The following criteria must be considered by the Facility Water Safety Committee when determining if the PCR negative screen will be utilized:

(1) The PCR test is to be done by a laboratory that is accredited and deemed to be proficient to detect Legionella in water samples by PCR. NOTE: Use of point-of-use PCR kits that do not meet the laboratory requirements in this appendix is not permitted.

Confirm with the testing laboratory that the PCR test will be completed with results reported in a timely manner after receipt of the sample and that the sample will be stored appropriately while PCR testing results are pending in case the sample will need to be processed by culture.

(2) The optional use of this PCR negative screen must be assessed on a building level. When deciding if this PCR option will be utilized for a building, it may be prudent to consider whether routine water testing for the building has been habitually negative, and the costs associated with the test. NOTE: The cost effectiveness of using the PCR negative screen is determined at the VA medical facility level.

(3) For samples that are Legionella-positive by PCR, the following requirements apply:

(a) The PCR-positive water sample must be processed by a culture method (in accordance with laboratory selection criteria) to confirm living Legionella are in the sample. While some PCR tests claim ability to differentiate between living and dead Legionella, such designations are not sufficiently reliable and use of the PCR result to determine that the Legionella are living is not permitted.

(b) While the results of the culture tests are pending, the following action is required:

assess the implementation of the engineering controls (e.g., water temperature, biocide levels) to determine if corrective adjustments need to be made.

(c) If the culture result of a PCR-positive sample is subsequently positive, follow the actions in paragraph 2.d. of this Appendix.

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d. Interpretation of Legionella Culture Results from Water Testing. If no Legionella are detected in all routine water samples, then the quarterly validation cycle is complete. If Legionella are detected by culture in at least one sample then there are three different sets of actions that are required: assessment of routine engineering controls, remediation requirements and considerations, and clinical validation. NOTE:

For subsequent clinical validation actions related to Legionella-positive environmental samples, see paragraph 3 of this appendix. See paragraph 5 of this appendix for a summary flow chart for interpreting routine water testing results.

(1) Assessment of Routine Engineering Controls. If environmental testing detects any amount of Legionella (any species) by culture, then the actions in this sub-paragraph are required. NOTE: The Legionella results must be evaluated on at least a building level since each building may have specific considerations to assess and improve implementation of controls. Assess the implementation of the engineering controls (e.g., water temperature, biocide levels) in the area(s) of the positive sample(s) to determine if corrective adjustments must be made. It is particularly important to assess and adjust implementation of engineering controls if the extent of Legionella colonization (e.g., percentage of positive outlets) or concentration of Legionella detected is high, or if the extent of Legionella-positivity or Legionella concentration has increased compared to previous quarters, since these findings could indicate that conditions in the water system are conducive to Legionella proliferation. NOTE: Assessment of engineering controls is a critical, primary response step since the purpose of routine Legionella testing is to validate that routine engineering controls are inhibiting Legionella growth.

(2) Remediation. This section describes the minimum actions required to mitigate potential risk after detecting Legionella in building water distribution systems during routine testing. NOTE: VA medical facilities may choose to implement more stringent actions. This is a local decision based on building risk assessments. For example, a building with a history of HCA LD at any time in the past may require remedial actions to be taken regardless of type or concentration of Legionella detected.

(a) Implement remedial action using the criteria in paragraph 2.d.(2)(b) of this appendix if environmental testing detects L. pneumophila at a concentration of one colony forming unit per milliliter (CFU/ml) or greater. This remedial action approach uses a “graded response” for addressing L. pneumophila-positive samples detected through routine water testing. That is, while each positive sample will require further assessment, the extent of remediation is situation dependent.

1. For areas of the building with individuals considered at higher risk for infection (e.g., transplant units, protective environments, hematology-oncology units), if environmental testing detects any amount of Legionella (any species), then follow the requirements in paragraph 2.d.(2)(b), below (graded response for remediation).

Consider whether other actions need to be taken to reduce the risk of exposure to Legionella until the remediation process is complete (e.g., moving of patients, use of point-of-use filters and use of bottled water).

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2. For areas of the building not considered to be higher risk, if the Legionella detected was not L. pneumophila or was L. pneumophila at less than 1 cfu/ml, then the Facility Water Safety Committee must determine what additional actions, if any, will be taken. The committee must consider the following factors when determining if remediation will be implemented using the graded response in paragraph 2.d.(2)(b) of this appendix:

a. Comparison of results to past quarters of testing to determine if the area is habitually positive for Legionella pneumophila, even at levels below 1 cfu/ml. NOTE:

The committee may choose to have more testing done in the area(s) if more data could be helpful in making a decision.

b. Comparison of results to past quarters of testing to determine if there is an increase in the extent of positivity regardless of Legionella species. That is, assess whether the data indicate that Legionella are proliferating in the water system. For example, this could be indicated by an increase in the percent of water samples in which Legionella were detected or an increase in the concentration of Legionella in water samples.

(b) The minimum remedial actions required to mitigate potential Legionella risk (i.e., the “graded response”) are as follows:

NOTE: The water system(s) to be remediated is determined by the types of water samples that were considered positive. If the positive results were from pure cold-water samples or pure hot water samples, then remediate the corresponding water distribution system (hot, cold or both). If the positive results were from mixed hot/cold samples, then the minimum requirement is to remediate the hot water distribution system; the Facility Water Safety Committee must determine if remediation of the cold water distribution system is also needed (e.g., based on additional testing or knowledge from past environmental testing results of hot versus cold water positivity).

1. If one water sample is determined to be positive, then, at a minimum, the fixture that tested positive must be promptly remediated by chlorinating the fixture and supply lines. Review past routine testing results in the area of the positive fixture to determine if more extensive remediation may be beneficial. NOTE: A VA medical facility may choose to conduct additional testing in the area of the positive fixture to determine if more extensive remediation is needed. Retest the outlet after remediation is complete to determine if the remediation was successful. If the remediation was successful, then the quarterly environmental validation cycle is complete. If the remediation was not successful at reducing Legionella positivity, assess the remediation procedure and repeat remediation and retesting until the remediation is successful. NOTE: When re-testing the water after remediation, wait at least 24 hours after remediation is complete before taking the water samples. This re-testing as post-remediation follow-up is not to be considered as a sample for the next round of routine quarterly environmental testing.

2. If more than one water sample is considered positive, assess the results to determine the subsequent actions as follows:

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a. If the water samples that tested positive are in the same area of the building or on the same water distribution loop, then promptly conduct remediation of the area or loop.

b. If the water samples that tested positive are in different areas of the building or on different water distribution loops, then promptly conduct remediation in a graded response based on location of the positive outlets. The Facility Water Safety Committee must meet to review the location of the positive water samples in relation to the configurations of the building water distribution system(s) to determine the extent of remediation (i.e., fixture, areas/loops versus the entire building). For example, if there are two positive sample results in different parts of the building and all other samples are negative, then the VA medical facility may determine that targeted remediation of each fixture is appropriate, or that remediation of those areas or loops with positive samples is appropriate (e.g., based on results from past quarters). If multiple outlets are positive throughout the building, then the VA medical facility must consider remediation of the entire water distribution system(s) in the building as described in Appendix A, paragraph 4. Detection of L. pneumophila in more than one outlet in different areas of the building water system on repeated cycles of routine quarterly water testing is also a strong indication for remediating the whole system. VA medical facilities must consider local factors (e.g., previous environmental testing results; VA medical facility size and configuration of water distribution systems; population risk factors; and past history of HCA LD) when determining the extent of remediation to be conducted. NOTE: The overarching goal is to use Legionella testing data to try to understand whether the pathogen is being controlled in the system and, if not, to what extent the data indicate that proliferation is occurring. Mitigating the risk of these validation results must be assessed on a case-by-case basis. Consultation from the Office of Healthcare Engineering (OHE) and the National Infectious Diseases Service (NIDS) is available for assistance with assessing validation testing results.

c. After remediation is completed, retest the water in the areas that tested positive to determine if the remediation procedures were successful. If the remediation procedures were successful, then the quarterly water environmental validation cycle is complete. If the remediation procedures were not successful, assess the post-remediation results for location of positive samples, assess the remediation process and repeat remediation and retesting until remediation is successful. NOTE: When re-testing the water after remediation, wait at least 24 hours after remediation is complete before taking the water samples. This re-testing of the water distribution system(s) for Legionella as post-remediation follow-up must not be considered as samples for the next round of routine quarterly environmental testing.

d. Documentation is required for environmental testing (e.g., date, outlets and results), any assessments of positive results, any remedial action taken and efficacy of remedial actions. NOTE: Discussion of environmental testing findings and remedial actions must be a component of the quarterly Facility Water Safety Committee meetings as described in paragraph 5.m.(7)). An annual summary report of these items must be submitted to the VA Medical Facility Safety Committee and Infection Control Committee.

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e. Reporting Environmental Testing Results. VA medical facilities are required to report environmental testing results, taken in accordance with Legionella testing requirements in this directive, to the VHA Water Safety Management Tool (WSMT) database or equivalent. The WSMT database can be found at:

http://vaww.hefp.va.gov/healthcare-engineering/water-safety-management-legionella.

NOTE: This is an internal VA website that is not available to the public. Further, this requirement pertains to the reporting of samples taken specifically for Legionella testing, including related readings such as biocide levels and water temperature. This requirement does not pertain to the reporting of routine or continual engineering control monitoring; those results must be recorded locally to monitor the implementation of controls.

(1) The required content, VISN Water Safety Liaison validation, frequency and timeframe for reporting results to the WSMT must be in accordance with the database User Manual. NOTE: The WSMT User Manual can be found on the VHA Water Safety Management & Legionella Resources intranet site at:

http://vaww.hefp.va.gov/healthcare-engineering/water-safety-management-legionella.

This is an internal VA website that is not available to the public.

(2) Reporting of environmental Legionella testing results is required for samples taken for any component of this directive, such as routine testing, post-remediation testing, or investigation of an LD case or cases.

(3) No clinical Legionella data are to be reported using the WSMT. Reporting of clinical Legionella data is to follow the requirements in the directive (paragraphs 5.g.(8)(a) and 5.g.(8)(b)).

3. CLINICAL VALIDATION

Clinical validation is the process of determining if the primary engineering controls and any supplemental actions are successfully inhibiting Legionella growth in the potable water distribution system(s) by monitoring the occurrence of HCA LD in VHA patients and residents. Although monitoring of visitors and employees for LD is not within the scope of clinical practice, learning that a visitor or employee is diagnosed with LD and had exposure to the VA medical facility is information that must be considered for assessment of engineering controls and need for further action. NOTE: This directive focuses on prevention of HCA LD. If a case of HCA LD is detected, this directive provides policy for immediate actions to prevent further cases. Guidance for case investigations of confirmed or suspected HCA LD is available from the CDC at:https://www.cdc.gov/legionella/health-depts/healthcare-resources/cases-outbreaks.html. Consultation with the VHA National Infectious Diseases Service is available if assistance is necessary. See paragraph 6 of this appendix for a summary flow chart for Clinical Validation.

a. Clinical Testing. Consider diagnostic Legionella testing for patients or residents who have pneumonia (community- or health care-associated); such testing is to be conducted if clinically indicated. Diagnosis of LD relies principally on use of Legionella http://vaww.hefp.va.gov/healthcare-engineering/water-safety-management-legionella https://www.cdc.gov/legionella/health-depts/healthcare-resources/cases-outbreaks.html https://www.cdc.gov/legionella/health-depts/healthcare-resources/cases-outbreaks.html

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Culture of sputum or other respiratory specimens for Legionella is also to be considered if these types of clinical specimens are collected during the course of clinical management of the case. If a case of LD is diagnosed, see paragraph 3.c. of this appendix to determine if there is a link of the case to the VA medical facility.

(1) If there are known cases of LD in the community (e.g., at other health care facilities in the surrounding area, from a known higher incidence of LD in the geographic area or alerts from the local Health Department) then it would be prudent to maintain a high index of suspicion of LD for patients that present to the VA medical facility with pneumonia.

(2) It would be prudent for clinical staff at the VA medical facility (e.g., infection prevention and control) to periodically assess whether patients with pneumonia, especially HCA pneumonia, are being tested for LD. This is especially important when conditions at the facility indicate the need for heightened awareness for clinical testing (see paragraph 3.b. of this Appendix). NOTE: Additional information on clinical diagnosis of patients with pneumonia for LD can be found at the VHA Water Safety Management and Legionella Resources intranet site located at:

http://vaww.hefp.va.gov/healthcare-engineering/water-safety-management-legionella.

This is an internal website and not available to the public.

b. Circumstances for Heightened Awareness for Clinical Testing. If Legionella is found during environmental validation testing, clinicians are to be vigilant for patients who develop respiratory disease or processes suggestive of pneumonia (e.g., fever with cough or production of sputum or radiographic findings) during their hospital admission or while under residential care, and perform testing of such identified patients for LD.

Clinicians also must have heightened awareness for clinical testing if a case of presumptive or possible HCA LD is detected for the building or if there is a community-based outbreak of LD. NOTE: For the situation in which environmental testing indicates positive Legionella results, the results must be communicated to clinical providers in order to initiate heightened awareness for clinical testing (see paragraph 4 of this appendix). If the Legionella detected during environmental water sampling is L.

pneumophila serogroup 1, then use of both urinary antigen testing and sputum culture for diagnosis of LD is appropriate. If Legionella other than L. pneumophila serogroup 1 is found during the environmental water sampling, then use of sputum culture for diagnosis of LD is appropriate; it is also reasonable to consider urinary antigen testing in addition to culture testing since L. pneumophila serogroup 1 may also be present in the water distribution system.

(1) This heightened state of clinical vigilance and testing as a result of positive environmental samples must be followed for at least 3 months and until the next round of quarterly water testing results are received. If Legionella is again found in the building’s water distribution system at the next quarterly testing, then the heightened state of clinical vigilance must continue for another 3 months. If Legionella are not found in the building’s water system, then the state of heightened clinical vigilance may end, and the VA medical facility may return to conducting routine clinical testing.

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(2) If a case of LD is diagnosed at the VA medical facility, see paragraph 3.c. of this Appendix for determination of linkage of the case to the health care facility.

c. Determination of Epidemiological Linkage of LD Cases to the Health Care Facility for Assessment of Remediation Needs. If diagnostic testing determines that any case of pneumonia is caused by any species of Legionella, then determine if the case is epidemiologically linked to the building using the following guidance.

(1) Presumptive HCA LD. If the person has spent 10 or more days continuously in a VA medical facility in the 14 days prior to the onset of pneumonia symptoms, then the case is classified as presumptive HCA LD. The remedial actions in paragraph 3.d. of this appendix are required. NOTE: “Presumptive HCA LD” was called “definite HCA LD” in previous policy. Classification of an HCA LD case as “presumptive” is a temporal determination based on length of continuous stay at the VA medical facility (at one or more buildings). Therefore, collection of water to determine if Legionella are detected is not a component of deciding if remediation is needed. Rather, such water collection prior to remediation is an option to assess the environmental situation (see paragraph 3.c.(2)(a) and paragraph 3.d.(2) of this appendix for more information on such water collection).

(2) Possible HCA LD. If the patient or resident had exposure to a health care facility for a portion of the 14 days prior to onset of illness, regardless of whether that contact occurred during an inpatient stay or outpatient visit/non-clinical contact (e.g., prescription pick up), then the case is classified as possible HCA LD. Possible HCA LD can be the result of only outpatient/non-clinical exposure in the 14 days prior to symptom onset, or only inpatient exposure in the 14 days prior to symptom onset, or both outpatient/non-clinical and inpatient exposure. The VA medical facility must assess possible association of an LD case with the VA medical facility on a case by case basis.

Conduct the following actions to determine if remediation of the VA medical facility water system(s) is necessary.

(a) For possible HCA LD resulting from inpatient exposure, collect environmental water samples from the hot and cold water distribution loops in at least the areas where the patient had contact with the building water distribution systems, including samples from ice machines and medical devices/equipment that may have been involved in exposure of the patient to water. Consider collection of swab samples of the outlets where water samples are collected. NOTE: CDC recommends collection of one-liter water samples and swab samples for investigation of LD cases. Consider non-potable water sources, such as cooling towers, if epidemiologically indicated. The environmental samples are to be processed for the culture of Legionella bacteria to determine if the species responsible for the person’s illness is detected in environmental samples.

(b) For possible HCA LD resulting from only outpatient or non-clinical exposure, consider factors that could indicate increased likelihood that the LD may have been a result of contact with the building such as use of water sources by the person or other cases of HCA LD with exposure to the same building in the past 12 months. The Facility Water Safety Committee must determine the extent of investigation needed, including a

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(c) If any of the environmental testing results are positive for L. pneumophila, or the species of Legionella associated with the case (if the case was not caused by L.

pneumophila), then the remedial actions in paragraph 3.d. of this appendix are required.

(d) If the environmental testing does not detect L. pneumophila, or the Legionella species associated with the case, then clinical staff are to remain vigilant for the identification of additional cases of LD for at least the next 3 months. Any LD-positive diagnostic result precipitates the actions in paragraph 3.c. of this appendix to determine if the case is linked to the VA medical facility. NOTE: Based on local conditions or circumstances, the Facility Water Safety Committee may determine that remediation is to be conducted even if the criteria above are not met. Consultation with HEFP and NIDS is available for guidance.

(3) If the VA medical facility compares patient and environmental Legionella isolates by molecular typing and the isolates are determined to be closely related, then the case is epidemiologically linked to the VA medical facility regardless of the duration of time the patient spent in the VA medical facility or the nature of the visit. The remedial actions in paragraph 3.d. of this appendix are required.

(4) If an HCA LD case is identified (whether presumptive, possible or molecularly linked), then implement heightened awareness for clinical testing as described in paragraph 3.b. of this appendix for a period of at least 3 months.

d. Remedial Actions. Linkage of a case of LD to the VA medical facility as described in paragraph 3.c. of this appendix requires the following immediate actions.

(1) The Facility Water Safety Committee must meet and review data on the implementation of the primary engineering controls and any supplemental actions to determine if there were any circumstances (e.g., construction activities, reduced water temperatures, reduced biocide residual levels) that could have resulted in Legionella growth and that require corrective action to restore the controls and systems to levels for ongoing suppression of Legionella growth. NOTE: If the Facility Water Safety Committee discusses any case of LD, patient information must be de-identified prior to sharing the information with the committee.

(2) Implement remediation, described in Appendix A, paragraph 4, as an immediate remediation of the potable water distribution system(s) in the building. Consider cleaning ice machines, medical devices and equipment as a way to prevent potential further transmission of Legionella if such apparatus may be associated with the diagnosed case. In the situation of a presumptive HCA LD case where taking environmental samples may not have been necessary to link the case to the VA medical facility, it may be prudent to collect environmental samples prior to implementing remediation to determine the extent of Legionella in the building water distribution system(s); however, remediation is not to be delayed until results are returned and not

C-12 to be canceled if results are all negative. Retest the water after remediation is complete to determine if the remediation was successful at reducing Legionella to undetectable levels. Detection of Legionella in subsequent environmental testing prompts a review of remediation procedures and further remediation and testing to reduce Legionella to undetectable levels. NOTE: Consultation with HEFP is available for guidance on remediation.

e. Case Reporting. Ensure that LD cases (community-associated and VA-associated) are reported as indicated in the directive (paragraphs 5.g.(8)(a) and 5.g.(8)(b)).

4. COMMUNICATION OF VALIDATION ACTIVITIES AND RESULTS AT THE VA

MEDICAL FACILITY

Legionella prevention and control in the health care setting is multidisciplinary.

Effective prevention of HCA LD requires timely communication among staff. This is especially important regarding interpretation and follow-up for positive validation results as delineated in this appendix, since positive results in one section triggers required actions in other sections.

a. If the results of the environmental validation are determined to be positive for Legionella, the following must be promptly notified of the type of Legionella detected and the location(s): VA medical facility Chief of Staff, the Associate Director for Patient Care Services, the Facility Water Safety Committee Chair, Infection Prevention and Control and Facility Chief Engineer or Facility Manager. The Chief of Staff and the Associate Director for Patient Care Services are responsible for ensuring that clinicians involved in direct patient care are notified of the positive environmental results, including the species and serogroup detected (if appropriate), in order to implement heightened awareness for clinical testing for LD as required in paragraph 3.b. of this appendix, and in accordance with the building HCA LD prevention plan.

b. If there is a presumptive or possible HCA LD case at the VA medical facility, Infection Prevention and Control must promptly notify the Chief of Staff, the Associate Director for Patient Care Services and the Facility Water Safety Committee Chair. This notification of the Facility Water Safety Committee Chair will initiate the committee’s review of engineering controls and implementation of the emergency remediation process, as appropriate, described above in paragraph 3.c. of this appendix.

5. SUMMARY FLOW CHART FOR INTERPRETATION OF ROUTINE QUARTERLY

ENVIRONMENTAL WATER TESTING CULTURE RESULTS IN THE ABSENCE OF

HCA LD

This flow chart summarizes the main concepts in Appendix C regarding Environmental Validation processes. For a summary of Clinical Validation processes, see the flow chart in paragraph 6. For details on these validation processes, see the text in Appendix C.

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No

L

1. Cllnlc-al Valldallon Heigtllened awareness for LO for 3 months ConSidet bolh d ln1,c ..

oultvres ~ UAT for dagnosis

Revle•N extent of poslh,.lly

2. Check Englne,rlng Controls

Make adjustment, as needed to be in ocml)llance -.1th control limilS

Is there an inaease in extent of positivity compa,ed to pre,,ious (1Jarter.s (regardless d species)?

Ate a subs1entiaf number of samples posllve'?

Determine if more 1~0 endl'or remeda'Cion is ne.eded

11 remecfalio, wlll be performed. condJd graded resoonse tor 11511 mtliQ&tlCl"I (Le . rollc>N lhe •yes· side as if samples were posll -.ie )

Retnediete outlet Check pest resdlsl determine If moie testno is needed « ~ der remec:lallon

• Remeclate loopla,eas wlh po~l11e s.a~es

• Considerbuldln~~de remech.tiQn

3. Rt mtcllaUon

No

No

Peffonn follO\i/·UP water sampling of the ~-----------------.i oullet/loophire&Jbuildng to deter-nine if M-----, remediation was successful.

O:uarlerly evMUalion IS tcmplele Continue program

~Should eltpaod lo tiny tcr,iondla at •nt concent,M.lon ro, h!gh-ll)k 11«>. &1'1.1 <o~·,c,te, !f 1)1:bt definite HCA-lO.

No

RfMew remediation protoeds and re-suit, Repeat retriedl11itlon.

C-14

6. SUMMARY FLOW CHART FOR CLINICAL VALIDATION

This flow chart summarizes the main concepts in Appendix C regarding Clinical Validation processes. For a summary of Environmental Validation processes, see the flow chart in paragraph 5. For details on these validation processes, see the text in Appendix C.

Cooduc-t Clinical

To.strng to, Lo,giOtte,,.

DiStHJu (see Appendix

C, parqsph 3s) llkety a non-VA ·comn-...nity- LO cue

Heightened cinicel awareness fOt mOl"O CH.S (3 months) Rornoellete aroa or building Perform follo.<•UP wate, tesl." g

Case IS POSSlbtt outpauenl.

Test wate, for "'9/onella In areas of exposure.

.. Evaluate need for water te-sting bued on exPosurot end risk

.. Implement hei&f',tened d inicel ewarenos, for 3 months knplemcnt heightened cwical awareness tor 3 mcnllts.

mplement he~tened ellnieal awarene&S fer 3 months Retnediate area er Duiding Perfcnn follow• up water testing

C-15

NOTE: If molecular typing was done and the patient Legionella isolate matches an environmental Legionella isolate, then follow the actions associated with a presumptive case of HCA LD.