TO: Michigan Department of Health and Human Services, Lansing, Michigan FROM: Centers for Disease Control and Prevention, Atlanta, Georgia National Center for immunization and Respiratory Diseases Laura A. Cooley, MD, MPHTM, Medical Epidemiologist, RDB, DBD Claressa Lucas, PhO, Research Microbiologist, RDB, DBO National Center for Environmental Health Jasen Kunz, MPH, Environmental Health Scientist, EHSB, DEEHS DATE: December 15, 2019 (Revised) REF: n of healthcare-associated Legionnaires’ disease — Flint, Michigan, January 2018— June 2019 BACKGROUND (On June 15, 2019, the Michigan Department of Health and Human Services (MDHHS) requested onsite “technical assistance from the Centers for Disease Control and Prevention (CDC) with an investigation of McLaren Flint Hospital (McLaren Flint) in response to cases of healthcare-associated Legionnaires’ disease (Appendix A), CDC had visited McLaren Flint previously with the Genesee County Healthy Department (GCHO)—in August 2016'—to investigate a single case of possible healthcare-associated Legionnaires’ disease with exposure to McLaren Flint. At that time, CDC determined that while McLaren Flint had taken considerable effort to create a water management program (WMP) since 2014-2015, when more than 50 cases of possible or definite healthcare-associated Legionnaires’ disease with ‘exposure to Mclaren Flint? had been reported, certain aspects of the WMP had not been fully implemented (¢.g.,disinfectant levels were not being monitored at points of use). OC has continued to provide MDHHS and GCHO with remote technical assistance. Every year since the 2926.anslta.nuassigation, thera has.hoen a} least one patlant reported with Lepioritaltenattzuass:end (sakuKaio-MckecenGliettionto.eymekom, onseieDUzine 14° yamMiOARIOnss RRA er ivan possible or definite healthcare-associated Legionnaires’ disease and exposure to McLaren Flint were reported, two of whom died. Review of environmental data from McLaren Flint (ve., water quality para} from March 2017-June 2019) raised concern that conditions supporting Legionella growth may continue to specific Legionella strain over time. * CDC report via MDHNS website, Availabe at: ito michigan gov/documents/mdhhs/COCMeLarenRepart S48049 7, * MOHHS used the following healthcare-specic exposure categories to define healthcare-associated cases ‘© Definite healthcare-associated case: the patient spent the entire 10 days before symptom onset at McLaren Flint '* Possible healtheare-associated case: the patient spent 2 portion of the 14 days before symptom onset at MeLaren FlotLegionnaires’ disease and exposure to McLaren Flint, MDHHS issued a public health order—in response public health investigation (Appendix B). 0 Regulatory Affairs (DLARA) issued a regulatory order to ensure compliance with the Public Health Code (Appendix C) ‘OnJune 18, 2019, a multidisciplinary CDC team, including a medical epidemiologist, an environmental health scientist, and a research microbiologist, travelled to Flint, MI, to assist MOHHS with an onsite Investigation of McLaren Flint, which took place June 19-21, 2019, Objectives of the investigation + Review clinical and epidemiologic information for the five patients with possible or definite healthcare-associated Legionnaires’ disease and exposure to McLaren Flint during January 2018-June 2019 © Review the facility’s previous environmental testing results, water quality parameter data, and WMP records * Evaluate the facility's plan for minimizing Legionella growth and transmission, including the facility's protocol for environmental Legionella testing and WMP validation * Conduct a comprehensive environmental assessment with representative sampling for Legionella + Evaluate the facility's protocols for clinical evaluation of patients with healthcare-associated pneumonia + Evaluate the facility’ protocols for collecting, processing, storing, and transporting lower respiratory specimens The Setting McLaren Flint isa 378-bed tertiary facility comprised of five buildings. Buildings A, B/C, and F have patient care rooms, Building D has an auditorium area, and Building E has a power plant. The City of Flint uses chlorine as a disinfectant in its municipal water. Three water service lines, which deliver chlorinated water from the water utility to McLaren Flint, meet in a mechanical room where the water supply passes through a booster pump and is distributed throughout the facility. A fourth service line serves Building € and four large cooling towers. The hospital has seven circulating hot water systems, six of which have secondary monochloramine disinfection systems. The seventh hot water system serves the kitchen area McLaren Flint installed point-of-entry cold water filters in April 2019. METHODS This report addresses the observations and findings from the onsite investigation at McLaren Flint conducted jointly by COC and MDHHS June 19-21, 2019. It also references information obtained from discussions with MDHHS, DLARA, GCHD, facility staff, and facility water management consultants, as well as environmental data covering the period September 2018-May 2019 (Appendix D) and Legionella environmental sampling data covering the period March 2017-June 2019 (positive results shown inAppendix E). Relevant epidemiologic information and microbiologic data from 2008-June 2019 were included for context. Descriptive epidemiology ‘The Council of State and Territorial Epidemiologists (CSTE) legionellosis case definition was used to classify cases of Legionnaires’ disease (Appendix A). According to this definition, a patient must have clinically compatible illness (i.e., evidence of clinical or radiographic pneumonia) and a confirmatory diagnostic test to meet public health criteria as a confirmed case of Legionnaires’ disease. For this investigation, MIDHHS used the following healthcare-specific exposure categories to define healthcare- associated cases + Possible healthcare-associated case: the patient spent a portion of the 14 days before symptom onset at Mclaren Flint GCHD staff performed patient or proxy interviews for the five patients with possible or definite healthcare exposure to McLaren Flint during January 2018-June 2019. GCHD electronically uploaded clinical information into the Michigan Disease Surveillance System, which MDHHS reviewed to confirm that each patient met case criteria for Legionnaires’ disease and to understand each patient's possible exposures during the period preceding symptom onset. MDHHS shared clinical information with COC. (On June 19, 2019, the investigation team (including CDC and MDHHS staff) met with McLaren Flint clinical and infection control staff to discuss the clinical details of the five patients, Clinical surveillance ‘On June 19, 2019, the investigation team spoke with hospital laboratory staff to review procedures for collecting, testing, and transporting clinical specimens to ensure timely diagnosis, Procedures for long term retention of clinical isolates for public health surveillance were also reviewed. ‘On4une 20, 2019, the investigation team met with clinical, infection control, and laboratory staff at McLaren Flint to discuss current practices related to active clinical surveillance for healthcare-associated pneumonia and clinical testing for Legionella (Appendix A). Active clinical surveillance summary statistics were requested following the site visit and received on July 1, 2019 Water management program review (On4une 19, 2019, the investigation team spoke with McLaren Flint infection control staf, facilities engineering and maintenance leadership, McLaren Flint leadership, and McLaren Flint water management consuttants (Special Pathogens Lab [SPL], Forensic Analytical Consulting Services [FACS] and Eldon Water) to better understand WMP implementation. The investigation team spoke with Eldon Water staff about the installation, operation, and maintenance of the monochloramine units (On June 20, 2019, the investigation team spoke with McLaren Flint environmental services staff responsible for implementing the point-of-use fixture flushing protocol. Following the onsite investigation, on July 31, 2019, the investigation team also spoke with representatives from McLaren Flint and Eldon Water to get clarification of Oxidation Reduction Potential (ORP) readings.‘The investigation team reviewed documents and records to assess updates to and performance of the WMP. The review focused on the following available records: Water quality parameter data (© Historical monochloramine level data (September 2018-May 2019), provided by Mclaren Flint and compiled by MDHHS (Appendix D) © Data collected during the 2019 onsite investigation including disinfectant residual, temperature, pH, and ammonia levels (Appendix F (© ORP records from all six monochloramine units (January 1, 2018-August 12, 2019), provided by Eldon Water via McLaren Flint on August 23, 2019 (Appendix 6) © Legionella environmental sampling results © Legionella environmental sampling results from the McLaren water system collected and/or processed during March 1, 2017-June 11, 2019 by 1) McLaren Flint water management consultants FACS and SPL, 2) GCHD, MDHHS, and the Michigan Bureau of Laboratories (BOL), and 3) MDHHS's water management consultants HC Info and Risknomics (positive results shown in Appendix ) ‘© McLaren Flint’s WMP and proposed updates for June/tuly 2019 (Note: McLaren Flint’s WMP is. reviewed and updated annually) ‘© Cooling tower operation and maintenance logs ‘© McLaren Flint's WMP team meeting minutes Environmental assessment and sampling ‘The investigation team used the following sources of information to develop a representative Legionella environmental sampling plan: '* Information about the facility's water systems from McLaren Flint facilities engineering and maintenance leadership © Epidemiologic information (i.e., patient location data and areas of possible exposure to water sources) + Water quality parameter data (Appendix 0) '* Historic sampling results (positive results shown in Appendix E) © Atour of the facility ‘The investigation team measured water quality parameters (total chlorine [i.e., an estimate of monochloramine levels) in the hot water, free chlorine in the cold water and occasionally also in the hot water, temperature, and pH) to characterize the potential risk for Legionella amplification. Ammonia and monochloramine levels were measured (using the HACH Monochlor F method) inthe hot water by ‘McLaren Flint’s water management consultant, FACS, who accompanied the investigation team,The investigation team conducted sampling for Legionella per previously published protocols*. Point-of- use filters were removed before swab and bulk water sampling to allow access to the piping interior. Biofilm samples from sink faucets and showerheads were collected with Dacron-tipped sterile swabs. Sodium thiosulfate was added to each bulk water and swab sample to neutralize chlorine-based disinfectant. Bulk water samples and swabs were maintained in insulated coolers and sent to the CDC Legionella laboratory within 24 hours of sample collection. Laboratory methods Environmental samples were cultured for Legionella at CDC according to previously described methods*. Samples were processed within 48 hours of collection and inoculated on buffered charcoal yeast extract {(BCVE) plates either without antibiotic selection or containing PCV and GPCV ([P] = polymyxin B (100,000 U/L, {V] = vancomycin (Smg/L), [C] = cycloheximide (80 mg/L), [G] = glycine (2 g/L). Isolates with suspect colony morphology were tested directly using a multiplex Legionella Polymerase Chain Reaction (PCR) assay, which detects Legionella species, L. pneumophila, and L. pneumophila serogroup 1° Genomic DNA from L. pneumophila serogroup 1 isolates was extracted and sequenced to provide molecular subtyping data. Genome sequences were analyzed using whole genome multilocus sequence typing (weMILST) after sequencing using the lumina MiSeq instrument®. Traditional sequence-based typing (SBT) alleles were extracted in silico from whole genome sequences or according to the methods of the European Study Group for Legionella Infections” ‘Available clinical specimens obtained from the patients with healthcare-associated pneumonia who were included in this investigation were processed at both Michigan BOL and the CDC laboratory. At the CDC laboratory, lower respiratory specimens were cultured for Legionella and the species and serogroup of resulting isolates was determined according to standard methods regulated by the Clinical Laboratory Improvement Amendments (CLIA). DNA was extracted directly from respiratory specimens and ‘examined by multiplex PCR‘. Where feasible, extracted DNA was also examined via a nested SBT method in which amplified alleles are subjected to Sanger sequencing to determine a Sequence Type of Legionella DNA present within the specimen’. With this method, DNA associated with the seven SBT loci is amplified directly from the specimen and sequenced, which is especially useful when an isolate cannot bbe recovered. Where isolates were recovered, they were subtyped by SBT and wgMILST exactly as described for environmental isolates. 2 coe. Sampling Procedure and Potential Sampling Sites, Avallabl at: wwrw cde gov/eionela/dounloads/ctc-samaling. procedure "Kotak WA ef dentietion of Legionella inthe environment. Methods Mo Bio 2013, 954:3-25, S eentex Al & Winchel IM Clinical apation of a multiplex realtime PCR assay for smultaneous detection of Legionella ‘pecis, eplonella pneumophilo, and Leplonela pneumophila serogroup 1 Jin Mierabio! 2013/51(1) 348-5 raphael BH, eo. Genome resolution of oubreakaszodatd Legionllopreumophia serogroup 1 isolates from New York Stat. Appl Enon Microbiol 2016;8212):3582-20. 7 Gai V, eto. Consensus sequence-based scheme for enidemiological typing of clinical and environmental slates of Legionella pneumophila Microbll2005;4315):2087-52. * The European Working Group for Lepianela Infections. Legionella SBT Quality Assessment, Avalabe at: Lbiinformatcs. che or.k/leionels/lesionla is * protocol avaiable at: ja pesionelaeionais 48 hours after admission, McLaren Flint has developed @ comprehensive system for ensuring that appropriate Legionella testing is obtained, requiring the full-time effort of one member of McLaren Flint's infection control team, ‘© Dally, this staff person pulls a report of all inpatients for whom a chest radiograph is ordered (for any reason) and a report of all patients receiving one of approximately 10, antibiotics commonly used to treat pneumonia. ‘© For any inpatient who appears on both lists, this staff person works with nursing, respiratory, and laboratory staff to ensure that UAT, routine lower respiratory culture,and culture of a lower respiratory specimen for Legionella are obtained; the staff person continues to follow each patient until all tests are obtained. (© Duplicate orders are cancelled. McLaren Flint is trying to discourage clinicians from ordering serial UAT. ‘+ Monthly, the infection control staff person cross-references the patients on their list with alist of diagnoses for discharged patients to ensure that no one with a pneumonia diagnosis has been. missed, ‘+ McLaren Flint staff utilize multiple pathways for communicating with treating clinicians. McLaren Flint adheres to GCHD's Legionellosis Guidance for Clinicians and distributes Michigan Health Alert Network messaging when recommended by public health. On occasion, they have also shared messaging via the Genesee County Medical Society. They have provided training on Legionnaires’ disease, primarily to Emergency Room staff. A review of requested active clinical surveillance summary statistics (Appendix!) revealed that the proportion of people on the list compiled by infection control staff described above who underwent testing for Legionella was high. Using May 2019 as an example, one patient was dropped from the original ist of 205 patients. Of 204 patients, UAT was ordered for 202 (99%) patients and performed for 194 (95%). Respiratory culture for Legionella was performed on 192 (94%). No list of diagnoses for discharged patients was provided for comparison. A few details were not clear in the active clinical surveillance summary statistics provided by McLaren Flint and will need clarification by MDHHS: ‘+ The denominator is defined as ‘pneumonia case with suspected Legionella on admission’ (Appendix!) Do these numbers include surveillance for inpatients who develop pneumoni after admission? ‘* Why were certain cases dropped from the denominator? ‘* What are the reasons a patient would be missing a UAT result (either because a UAT was not ordered or because a UAT was ordered but the test was not completed)? Findings of water management program review ‘The WMP was developed by McLaren Flint’s water management consultant SPL and was finalized just after the 2016 CDC onsite investigation, on August 31, 2016. It has been updated annually, in April/May 2017 and again in June 2018. Proposed June/July 2019 updates were discussed during the 2019 onsite investigation during a meeting with representatives from SPL, FACS, and McLaren Flint staff. Updates to the WMP, as proposed by McLaren Flint and McLaren Flint water management consultants SPL, include: * Removal of disinfectant and temperature monitoring, as well as Legionella v cold water * Inclusion of ice machines as part of Legionella validation testing, to occur quarterly, rotating ‘through all ice machines by sampling a subset each quarter; the corrective action for a positive Legionella detection includes cleaning and disinfection of the ice machine Inclusion of the newly installed point-of-entry cold water filters into the WMP; these filters, installed in April 2019, consist of two stages, the first filter removing larger material at the 40 9‘micron level and the second filter removing finer material at the 10 micron level; the filters are replaced every two to six weeks when the pressure differential between the incoming and ‘outgoing water exceeds 15 psi; there are eight cartridges in each of the two filter vessels * Updated building water system flow diagrams * Removal of monochloramine system upper and lower disinfectant concentration operating goals, which have been included in past versions of the WMP separately from control mits (note: contro limits will remain and align with ASHRAE 188 terminology) * Deletion of the whirlpool spa (which has been physically removed) * Deletion of the Ballenger Auditorium decorative fountain (which has been physically removed) ‘The investigation team asked McLaren Flint environmental services staff about building water system flushing activities in the WMP. McLaren Flint staff indicated that while they are implementing a robust flushing plan, itis not documented in the WMP. The investigation team spoke with McLaren Flint environmental services leadership in charge of implementing the flushing program. They said that environmental services staff flush all sinks and showers for the duration of room cleaning, at least two minutes, daily and at patient discharge. Flushing occurs in the hot water lines. McLaren Flint’s water management consultant indicated that, because Legionella is not expected to amplify in the cold water, cold water is not a primary focus of the flushing program or WMP. The investigation team observed flushing as described per the established protocols during a random spot check while conducting Legionella environmental sampling. The investigation team requested and received copies of WMP team meeting minutes dating back to January 2018, Review of the meeting minutes revealed that the WMP team, consisting of McLaren Flint administrative leadership, facilities engineering and maintenance leadership, and McLaren Flint’s water management consultants (FACS and/or SPL), convened monthly to discuss: * Previous meeting minutes ‘© Monochloramine unit testing results ‘© Clinical surveillance results (i.e., new cases of Legionnaires’ disease diagnosed at McLaren ‘© Legionella environmental sampling results (including both quarterly results and any testing performed in response to cases of disease) © External events potentially affecting McLaren Flint (e.g., new cases of Legionnaires’ disease diagnosed elsewhere in Genesee County) ‘The investigation team requested and received cooling tower operation and maintenance records dating, back to January 2018, Review of the records revealed that McLaren Flint’s cooling tower system was cleaned and disinfected by hyperchlorination on April 4, 2019, by another water management consultant, NALCO. The NALCO representative indicated, prior to the cleaning and disinfection, that Mclaren Flint cooling towers are in fair condition and that both crossflow systems have debris in the basin. A 24-hour pre-disinfection procedure was completed prior to the mechanical cleaning as directed by the protocol. The NALCO representative indicated, as part of the post-cleaning inspection comments, 10that all towers had been mechanically cleaned and given approval by FACS representatives on site. The NALCO representative further recommended that the insulation material located around the exhaust should be removed because itis at risk for biological growth and is not adding to the performance of the towers. The NALCO representative commented that the cooling towers should, at the very least, undergo an annual offline cleaning and disinfection with the addition of biodispersant (chemical that penetrates and breaks-up biofilm) throughout the year to keep the cooling towers cleaner for longer periods of time. ‘The NALCO representative determined the scale and corrosion inhibitor feed pump was not primed in July 2018 for cooling towers #2, #3, and f#4 and recommended that it be replaced due to previous issues with the pump losing prime. The NALCO representative acknowledged that McLaren Flint staff were aware the pump needed replacing. The NALCO representative also noted that cooling tower #4 isthe last to run, based on cooling demand, and when not running sits in a stagnant condition. Cooling tower 4#4 was found to be not running during the August-November 2028 NALCO monthly service visits. The NALCO representative recommended during the June 2019 visit that all cooling towers are circulated to help control system chemistry and reduce the risk of biological growth. The investigation team met with Eldon Water representatives to discuss the installation, operation, and ‘maintenance of the six separate monochloramine systems that serve McLaren Flint. The six ‘monochloramine systems serve hot water only in the following locations: ‘© Building A hot water (HW) system: Monochloramine system #3, ‘© Building 8/C upper HW system: Monochloramine system #5 ‘© Building B/C lower and kitchen HW system: Monochloramine system #4 Sub C wing HW system: Monachloramine system #6 ‘Building F upper HW system: Monochloramine system #1 ‘Building F lower HW system: Monochloramine system #2 Eldon Water engineering staff provided an overview of how the six monochloramine systems are plumbed and installed. Eldon Water staff answered questions from the investigation team about chemical injection locations and how the computer monitors and adjusts monochloramine levels. Eldon Water staff provided the following operation and maintenance details, which are relevant to this investigation: ‘+ Monochloramine is injected and measured at the hot water return line prior to reheat. Further conversation revealed this is an Eldon Water standard installation practice for other ft utilizing monochloramine systems. ‘+ Eldon Water monitors the monochloramine systems remotely, and if they alarm or malfunction ‘Mclaren Flint is notified. ‘© Eldon Water performs monthly visits to inspect the monochloramine systems and make any needed repairs or system modifications. ‘© Monochloramine chemicals are kept no longer than three months at McLaren Flint. a‘+ Each July, the monochloramine system pumps undergo a rebuild. The monochloramine data set (Appendix D) consists of weekly readings conducted by Mclaren Flint staff at various control point locations within the six monochloramine systems. The McLaren Flint WMP defines the monochloramine operating goal as 1.5 —3.0 mg/L (hot water) and the control limit as 1.0- 4.0 mg/L (hot water). Review of the monochloramine records during September 2018-May 2019 Identified the following: ‘+ Monochloramine system #S experienced monochloramine levels elevated above the upper control limit (4.0 mg/L) during October-November 2018. December monochloramine system #5 levels dropped sharply just below the lower control limit (1.0 mg/L). Review of the November 2018 McLaren Flint WMP meeting minutes revealed that monochloramine system #5 was experiencing problems and was expected to be corrected with the installation of a new check valve. The check valve was installed on December 19, 2018. Monochloramine levels stabilized within the control limits following the instalation of the check valve ‘+ Review of Legionella testing results for monochloramine system #5 revealed two positive detections of Legionella during the November 27, 2018 (n=1) and November 28, 2018 (n=1) Legionella environmental sampling activities. ‘* Review of the WMP team meeting minutes for November 2018 stated that monochloramine systems #1, #3, #4 and #6 were working properly and within range. System #2 had corrections to the chemical flow remotely made by Eldon Water and improvement was shown. Review of the monochloramine levels indicated that system #2 experienced two deviations outside the upper and lower control limits during October 2018. ‘+ Monochloramine system #3 experienced monochloramine levels elevated above the upper control limits during November 2018 and February 2019. Monochloramine levels of 4.55 mg/L and 4,6 mg/L were observed on two separate weekly readings during November 2018, and again in February 2019 with readings at 5.0 mg/l. Review of the December WMP team meeting ‘minutes indicated corrections were made same day to the monochloramine system #3. Review of Legionella testing results for monochloramine system #3 revealed four positive detections of Legionella during the November 29, 2018 (n=3) and December 13, 2018 (n=1) Legionella environmental sampling activities. ‘McLaren Flint has ORP meters installed on the six separate monochloramine systems. Measuring the CORP in the hot water systems combined with other measures (e.g., free ammonia, monochloramine levels, pH, and temperature) provides a point-in-time indicator of the water quality. The ORP indicates the availabilty of free electrons and the oxidizing tendency of the water. It is measured in millivolts using an ORP electrode. When ORP trends downward in a monochloramine system it may be used as an indicator that nitrification is occurring or about to occur. Additionally, downward trending ORP may be used as an indicator that overall system water quality is degrading. Review of the ORP data (Appendix G) revealed monochloramine system #6 experienced multi-month downward trending and then "Sigg . Redox Potential Measurements in Natural Waters: Significance, Concepts, and Problems, Redox Fundomentls, Processes and Applications 2000;32:1-12. 2rebounding of ORP levels on two occasions (April-May 2018 and October 2018-March 2019). ‘Monochloramine system #4 experienced multi-month downward trending and then rebounding on one ‘occasion (October 2019-December 2019). Retrospective review of MDHHS Legionella environmental sampling results and locations taken during March 1, 2017—June 11, 2019 (positive results shown in Appendix E), revealed that McLaren Flint primarily focused WMP activities on the hot water systems which were served by supplemental monochloramine systems. Furthermore, Legionella testing validation activities are largely confined to the hot water systems. Since 2017, available results from Legionella environmental sampling conducted in response to cases and as part of routine validation has revealed infrequent positive Legionella cultures within the hot water system. This suggests that risk within the hot water system continues to be reduced, however the outbreak strain still persists as a subset of the positive hot water Legionella samples. When Legionella environmental sampling has been expanded to the cold water system in the course of case response or efforts to investigate issues at points of use, Legionella was detected. The investigation team observed a number of concerning Legionella environmental sampling trends in the cold water system based on review of culture data from March 1, 2017—June 11, 2019 (positive results shown in ‘Appendix E) and June 19-20, 2019 (Appendix f). Ice machines tested positive in 2017 and then again, during the 2019 onsite investigation. Additionally, ice machines were not included in the McLaren Flint WMP until the most recent 2019 update, representing a potential missed patient exposure source”. ‘The drinking fountains tested positive in 2017 and then again during the 2019 onsite investigation (Appendix F). This is concerning because McLaren Flint installed 0.2 micron inline filters on the drinking, fountains over the course of 2018-2019 to reduce Legionella exposure risk. Due to the configuration of the inline filters inside the drinking fountains (e., not located at the point of use}, itis possible that the drinking fountains could be contaminated between the filter and the point of use, meaning that the inline filters may not be preventing Legionella transmission; as such, the use of inline filters is not recommended as the sole method of prevention unless placed at the most distal point (ie., at the point of use). Cold water point-of-use devices (e.g,, faucets and showerheads) have tested positive for Legionella on a ‘number of occasions at McLaren Flint from 2017 to the 2019 onsite investigation (Appendix F). Because the cold water system has been considered to be at low risk in the McLaren Flint WMP, infrequent Legionella validation sampling occurs. The lack of Legionella validation sampling (in accordance with the WMP) decreases the likelihood of detecting Legionella growth and exposure risk within the cold water system. Its possible that point-of-use contamination of the cold water system represents a missed and unmanaged patient exposure source at McLaren Flint. The decision by McLaren Flint to remove cold water disinfectant and temperature monitoring, and Legionella validation testing from the 2019 WMP does not appear to have been based on a comprehensive and current hazard analysis of the cold water system. 2 stout J, etal. Legionella in an ice machine may be a sentinel for drinking water contamination. Infect Control Hosp Epidemiol 2010 Mar;33(3):337. 13Findings of environmental assessment The locations of Legionella environmental sampling and corresponding water quality parameter measurements are listed in Appendix F. Hot water post-flush temperatures observed at point-of-use fixtures ranged 94.1°F-115,7°F. Return locations temperatures at the hot water heater ranged 107.8°F— 115.7°F, which is well within the growth range for Legionella. ‘Adequate post-flush hot water monochloramine disinfectant levels (range: 0.9 mg/L-3.2 mg/L) were observed at all sampling points. Additionally, free chlorine measurements were taken in the hot water system. Monochloramine interference in the sample reaction may have contributed to the observe of higher free chlorine levels in the hot water system compared with the level provided by the City of Flint. Detectable post-flush cold water free chlorine disinfectant levels (range: 0.7 mg/L-3.4 mg/L) were observed in point-of-use locations throughout the entire facility. It is unclear why elevated free chlorine levels, well above the typical incoming cold water free chlorine levels, were observed in several F tower locations on June 19, 2019. However, the elevated free chlorine levels do not impact the recommendations made in this report. Cold water free chlorine disinfectant levels (range: 1.2 mg/L-1.5 mg/l) in water entering the building from the water main were within limits recommended by the U.S. Environmental Protection Agency (€PaA). During the 2019 onsite investigation, potential patient exposure to aerosols generated by sinks was visually assessed. In the Emergency Room, the investigation team observed splashing in scrub sinks. The inherent design of these scrub sinks appeared to result in splashing; location of the sinks in close proximity to patients in these rooms represents a potentially Important source of aerosolized water exposure for McLaren Flint patients. Environmental sampling results ‘The investigation team conducted environmental sampling June 19-20, 2019, concurrently with staff from McLaren Flint’s water management consultant, FACS. Samples were collected in duplicate, with COC receiving the first draw. Culture was performed at both the COC laboratory and at SPL. Culture results from the CDC laboratory are presented in Appendix. Briefly, a total of 135 samples were collected from 52 sites or fixtures. Sample types collected at point of use fixtures (e.g. faucets, showers, drinking fountains) included first draw hot water (n=28), post-flush hot water (n=28), cold water (n=19}, and biofilm swabs of fixtures (n=31). Ice and swabs ofthe interior were collected from 10 ice machines. Samples collected in mechanical rooms included five bulk water samples from the hot water return lines, one bulk water sample from a hot water storage tank, and two cold water samples from the water ‘main intake (pre- and post-filter). A bulk water sample was also collected from an outdoor decorative fountain L. pneumophila serogroup 1 was cultured from five sites that included two ice machines and three cold or blended water samples from three sinks. L. rubrilucens or non-fluorescent, non-pneumophila legionellae were cultured from four sites, including one shower, one sink, and two ice machines. L. anisa or other blue-white fluorescent, non-pneumophila legionellae were cultured from 8 sites, including three sinks, one shower, two drinking fountains, and two ice machines. Isolates recovered from fixtures 14were detected in cold or blended water or from biofilm swabs but not hot water samples, whether first draw or post-flush. Three sites (533 shower, 11" floor ice machine, and OR3 east sink) yielded multiple types of legionellae. Comparison of environmental and clinical isolates "SBT molecular subtyping was performed on the seven L. pneumophila serogroup 1 isolates obtained {rom environmental samples collected June 19-20, 2019 (Appendix). These results were compared to, ‘to McLaren Flint during 2008—June 2019 and 20 environmental isolates obtained from hospital (clade). In 2015, two L. pneumophila serogroup 1 ST2 isolates were obtained from McLaren Flint’ cooling tower; these isolates displayed only 90.8% identity to the clade that included clinical isolates. Isolates from other clinical and environmental sources within the county unrelated to McLaren Flint displayed 96.8% or less identity to the clade that included clinical isolates from McLaren Flint, DISCUSSION Since 2014-2015, when more than 50 cases of possible or definite healthcare-associated Legionnai disease with exposure to McLaren Flint were reported, patients with Legionnaires’ disease with epidemiologic links to McLaren Flint have continued to be identified. During January 2018-June 2019, five patients with possible or definite healthcare-associated Legionnaires’ disease and exposure to McLaren Flint were reported. Clinical isolates obtained from two of these patients were highly related by weMLST to other clinical and environmental isolates associated with McLaren Flint. Hospitalized patients are particularly vulnerable to Legionnaires’ disease. As such, additional efforts are needed to ensure that the risk for ongoing Legionella transmission has been minimized. There are both clinical and environmental factors to consider. 1sindicator of inadequate WMP performance, thereby triggering public health actions to identify and, “remediate the source of exposure, which can prevent additional cases. The index of suspicion for infection with Legionella must be high ina facility with evidence of ongoing disease transmission over a period of years. Where epidemiologic associations exist, stvct surveillance definitions may need to be expanded to avoid missing cases of healthcare-associated Legionnaires’ disease. As mentioned earlier, for the patient with more than 14 days between exposure to McLaren Flint and reported onset of illness, microbiologic testing ultimately revealed thatthe Legionella isolated from the patients sputum was highly related to other clinical and environmental isolates associated with Mclaren Flint (Appendix J: Sample CL18-200120), indicating that the most likely source of exposure to Legionella for this patient was indeed McLaren Flint Furthermore, Legionnaires’ disease presents similarly to severe pneumonia caused by other bacterial pathogens, making specific diagnosis paramount, For example, clinical suspicion of aspiration pneumonia does not exclude Legionnaires’ disease as a diagnosis; in fact, while Legionnaires’ disease is usually acquired by inhalation of Legionella-containing aerosols, it also occurs by aspirating Legionella: containing water or ice, which may be a more prominent mode of Legionella transmission in healthcare facilities, where risk factors for aspiration (e.g., dysphagia) are more prevalent, compared with other settings (Appendix A). As such, Legionnaires’ disease should be included in the differential diagnosis for all patients with pneumonia and epidemiologic links to McLaren Flint Systematic approaches to diagnosis are also important. McLaren Flint’s described approach to active clinical surveillance is thorough and ambitious. Their decision to appoint someone specifically to track Legionella testing among patients indicates a clear investment in identifying associated cases. The key now isto ensure that this approach to active clinical surveillance is working as designed to detect cases, ‘meaning that the right patients (Le, patients with pneumonia and an indication for testing, which here includes current or recent exposure to McLaren Flint) are being tested in a timely manner (.e., pon diagnosis of pneumonia, prior to or concurrent with the initiation of antibiotic administration), using the right tests (i.e., UAT and culture of a lower respiratory specimen for Legionella) ‘The BinaxNOW UAT was validated on hospitalized patients and is indicated for use only in patients with signs and symptoms of pneumonia. Excretion of Legionella antigen in urine may vary. While a UAT may produce a negative result following the initiation of appropriate antibiotic treatment, antigen excretion can persist for up to one year afterwards in rare cases", Despite this variation, a positive UAT is, diagnostic for Legionnaires’ disease in a patient with pneumonia, according to the CSTE case definition (Anpendix A). Once a positive UAT result has been obtained, serial testing with UAT is not recommended. Furthermore, confirmation with a second clinical test is not needed to meet the case definition for Legionnaires’ disease in a patient with pneumonia and a positive UAT. Respiratory culture, while extremely helpful when positive, can be falsely negative in a patient with Legionnaires’ disease for a number of reasons (e.g,, preceding exposure to antibiotics, poor specimen quality) Early identification and treatment of Legionnaires’ disease reduces individual patient morbidity and ‘mortality. While standardized order protocols for Legionella testing can reduce the likelihood of missed opportunities for diagnosis, itis important that clinicians also ‘think Legionella’ when testing is indicated "kohler et a, Onset and duration of urinary antigen excretion in Legionnaires disease. J Clin Mirobio! 1984; 20:605-607, 16and strongly consider including empiric coverage against Legionella (e.., fluoroquinolones, macrolides) while testing is pending. Systematic efforts to reach all treating clinicians with clear instructions regarding Legionnaires’ disease testing and treatment are necessary. ‘When there is concern for ongoing transmission of Legionella, based on factors such as Legionella- positive environmental cultures, new cases of Legionnaires’ disease, or suboptimal performance of the WMP, immediate control measures may be necessary to protect patients, staff, and visitors from. exposure to Legionella, Examples of control measures include water restrictions (.g., avoiding exposure to all forms of aerosolized water and consumption of nonsterile water or ice) and installation of 0.2 ‘micron biological point-of-use filters. The extent and duration of these control measures, determined by ‘the findings of the investigations and the effectiveness of subsequent interventions, should be decided in conjunction with MDHHS. ‘Water management is a continuous and team-centric process. A facility the size of McLaren Flint generates a significant amount of water management data. Therefore, sound data management is necessary to identify trends in water management data needed to further refine Legionella risk reduction practices. Since the onsite investigation in 2016, Mclaren Flint has made significant strides in water management through the implementation of a WMP modeled on the principles of ASHRAE 188. Additionally, McLaren Flint has instituted a culture of WMP improvement through data analysis, which ‘was evident during the 2019 onsite investigation, However, given the continued identification of cases of Legionnaires’ disease associated with McLaren Flint and a hot water system that is, by design, in the permissive zone for Legionella growth (as described in the 2016 investigation report’), additional WMP refinements are warranted. fee Teantof the oust ehtaned fom th colng over, emlonmentl soles {rom another healthcare facility located within the same county, or isolates obtained from residents of the county without an exposure history to McLaren Flint. Combined, these results strongly suggest — ‘Samples from the 2019 onsite investigation that yielded isolates genetically related to McLaren Flint’s clinical case clade were from cold water, ice, or swab sources. None of the samples collected from hot ‘water sources, whether first draw or post flush, yielded any Legionella isolates, though such sources are ‘more often associated with transmission of Legionnaires’ disease than cold water sources. It should be noted that most hot water outlets at McLaren Flint are tempered with cold water at the fixture to "ptandellLA, eto. Consensus guidelines on the management of caemmurty-acquired pneumonia in adults. Clin ect Dis 2007; 44:527-72, °S COC report via MDHHS website, Available at hts: michigan nou/documents/mdhhs/COCMeLarent v7prevent scalding, Thus, itis difficult to determine ifthe most likely source of exposure to patients was directly rom cold water/ice or tempered hot water. Additionally, the June 2019 sampling event focused ‘on only two of the monochloramine loops and so the full extent of the distribution of McLaren Flint clinical clade legionellae is currently unknown, Given the recent definite and possible healthcare-associated cases of Legionnaires’ disease associated ‘with Mctaren Flint it is premature to consider declaring he end of the outbreak at this time. However, it can be helpful for all interested parties to understand the process and considerations in ultimately declaring that an outbreak has ended. Such decisions are typically made by the health department with jurisdiction, not by CDC, and are decided on a case-by-case basis. Possible considerations include: + No new cases of Legionnaires’ disease identified during a period of careful monitoring for new cases + No detection of outbreak-associated Legionella in post-remediation environmental samples Performance of the facility's WMP (ie., assurance that the facility's WMP is effective in preventing ongoing transmission of Legionella) The timeframe for enhanced environmental and clinical surveillance following an outbreak may need to be extended at any point if public health officials have concern for the potential for ongoing transmission of Legionella, based on factors such as Legionelio-positive environmental cultures, new ‘cases of Legionnaires’ disease, or suboptimal performance of the WMP. ‘exposure to Legionella. While a specific . pneumophila serogroup 1 ST1 strain has been identified through molecular characterization to be associated with disease at McLaren Flint, all. pneumophila serogroup 1 strains can cause disease. Detection of L. pneumophila serogroup 1 should thus be considered as evidence of the presence of the outbreak strain when additional molecular typing information is unavailable. From a public health perspective, no safe levels of Legionella have been demonstrated", particularly in healthcare settings. While ‘evidence of amplification’ at a single site (Le., increasing concentrations in serial samples) is concerning, persistence of a single strain of Legionella over time throughout a water system, even at low levels, is evidence of sustained, ongoing risk. Continued efforts to maximize the performance of McLaren Flint’s WMP is needed. Because of continued occurrence of facility-assoctated cases, this WMP must not be viewed only as a prevention tool as outlined in ASHRAE 188; itis also a response tool, for which additional steps are necessary. If itis Impossible for McLaren Flint to eradicate the outbreak strain under current conditions, additional efforts may be needed. 2 pemisian A, ta. The importance of clinical surveillance in detecting Legionnaires’ disease outbreaks: large cutbreak ina hospital witha Legianela disinfection system—Pennsyvania, 2011-2012, Cin infect O's 2015;60(11)-1586-1602. 8CDC RECOMMENDATIONS Immediate control measures to reduce possible exposure to Legionella McLaren Flint Potable water © Continue use—and proper maintenance—of 0.2 micron biological point-of-use filters on all outlets as instructed by MDHHS. Areas of use may need to be expanded in the future in some circumstances, for example: + Identification of new possible or definite healthcare-associated cases of Legionnaires’ disease, if review of patient locations reveals exposure to nonfiltered outlets Identification of L. pneumophila serogroup 1 from environmental samples obtained from nonfiltered outlets + Evidence of poor WMP performance (e.g,, concerning monochloramine trends) in areas of the water system with nonfiltered outlets © Use of point-of-use filters should be continued until MOHHS feels that the risk for Legionella growth and transmission has been adequately minimized. Given the evidence of persistent presence of a disease-causing strain of Legionella in the water system, CDC recommends continuing targeted point-of-filter use (in areas of identified risk) until 12, months have passed with no possible or definite healthcare-associated cases and no identification of L. pneumophila serogroup 1 in the water system. (© Engineering or administrative modifications could be required if L. pneumophila ‘serogroup 1 continues to be identified (during which time point-of-use filters should remain in place), © Icemachines (© Take all ice machines at Mclaren Flint out of service until MDHHS feels that the risk for Legionelta growth and transmission has been adequately minimized. Use ice only from ‘an external source until directed otherwise by MDHHS. © Before resuming use of ice machines, McLaren Flint should clean and disinfect allice machines and demonstrate—for each ice machine—absence of L. pneumophila serogroup 1 in samples collected at two-week intervals for three consecutive months, followed by samples collected monthly for another three consecutive months” (or as directed otherwise by MDHHS). © Engineering or administrative modifications—or ice machine replacement—could be required if L. pneumophila serogroup 1 continues to be identified. + recommendations of COC and the Healthcare Infection Control Practices Advisory Committee: Guidelines for Preventing eta aseited Preumon, 2003, valable at s/c go efectoncondgietne Meat: aus newonis- 19(© Once MOHHS has determined that the period of enhanced surveillance for ice machines is over and approves resumption of use, all ce machines should be sampled at least quarterly until directed otherwise by MDHHS and taken offline immediately should L pneumophila serogroup 1 be identified. (© Cleaning and maintenance should be performed per manufacturer's instructions, © Drinking fountains © Take all drinking fountains at McLaren Flint out of service. (© Before resuming use of drinking fountains, McLaren Flint should clean and disinfect all drinking fountains and demonstrate—for each drinking fountain— absence of L. pneumophila serogroup 1 in samples collected at two-week intervals for three consecutive months, followed by samples collected monthly for another three consecutive months” (or as directed otherwise by MOHHS). ‘© Engineering modifications to accommodate a new point-of-use filter configuration or drinking fountain replacement could be required if L. pneumophila serogroup 1 continues to be identified. ‘© Once MDHHS has determined that the period of enhanced surveillance for drinking, fountains is over and approves resumption of use, all drinking fountains should be sampled at least quarterly until directed otherwise by MDHHS and taken offline mediately should L. pneumophila serogroup 1 be identified. ‘© Routine cleaning and maintenance should be performed per manufacturer's instructions. Disease surveillance McLaren Flint ‘Ensure that all patients with clinical or radiographic pneumonia and indications for Legionella testing (regardless of suspected etiology), including patients with current or recent exposure to Mclaren Flint (ie., within the 14 days prior to onset of symptoms, or longer as indicated by strong epidemi ks), undergo Legionella testing. Both UAT and culture of a lower respiratory specimen for Legionella should be performed upon diagnosis of pneumonia, prior to or concurrent with the initiation of administration of antibic * For those patients for whom Legionella testing is ordered, strongly consider administering empiric coverage against Legionella (e.g., fluoroquinolones, macrolides) while test results are pending. * Report all patients with positive Legionella testing result to MDHHS within 24 hours of result, * Ensure that all clinicians receive adequate training regarding diagnosis and treatment of Legionnaires’ disease. Also ensure that they understand the context for concern within McLaren Mandell LA, eto Consensus guidelines on the management of communty-acquired pneumonia in adults. Clin Infect Dis 2007; 44:827-72. 20Flint and receive timely notification when L. pneumophila serogroup 1 is identified in the water system and/or other possible or definite cases of Legionnaires’ disease have been diagnosed. * During the period of active clinical surveillance, provide notification upon discharge for al patients that, should they develop signs and symptoms of pneumonia, they should immediately seek medical care and that testing for Legionella should be included in their diagnostic evaluation. McLaren Flint should work with MDHHS to develop appropriate messaging. © When lower respiratory specimens are obtained for Legionella culture, continue current practice Of splitting the sample, freezing half, and submitting the frozen half within 48 hours to Michigan BOL. MDHHS * A review of active clinical surveillance summary statistics indicates that McLaren Flint’s approach seems to be fairly effective for testing patients diagnosed with pneumonia on admission, however a few details need clarification, as mentioned in the Results: ‘© The denominator is defined as ‘pneumonia case with suspected Legionella on admission’ (Appendix |). Do these numbers include surveillance for inpatients who develop pneumonia after admission? © Why were certain cases dropped from the denominator? ‘© What are the reasons a patient would be missing a UAT result (either because a UAT was not ordered or because a UAT was ordered but the test was not completed)? + Periodically review summary statistics from McLaren Flint’s active clinical surveillance efforts to verify that all appropriate patients are undergoing Legionella testing via both UAT and culture of a lower respiratory specimen for Legionella and that this testing is occurring immediately upon iagnosis of pneumonia, before or concurrent with the initiation of administration of antibiotics. This includes a review of statistics from the infection control lst, as well asa review of the monthly cross-reference with diagnoses of pneumonia ‘+ Determine duration of active clinical surveillance based upon review of factors such as identification of additional cases, persistence of L. pneumophila serogroup 1 in the water system, and concerns regarding performance of the WMP. Given the evidence regarding the persistent presence of a disease-causing strain of Legionella in the water system, CDC recommends continuing active clinical surveillance until 12 months have passed with no possible or definite healthcare-associated case and no identification of L. pneumophila ‘Serogroup 1 ST1 in the water system. ‘+ Inaneffort to improve the understanding of sources of exposure for clinical disease, continue to process clinical isolates from McLaren Flint for sequencing at Michigan BOL. ‘© Continue to communicate with GCHD regarding findings and interventions. aWater management McLaren Flint = Monochioramine ° Monochloramine systems require strong oversight and operation and maintenance procedures to optimize system performance (e.g, to ensure consistent ‘monochloramine levels at points of use throughout the hot water system) and prevent unintended consequences (e,, system nitrification). Conduct trend analyses of ‘monochloramine systems (e.g., monochloramine levels at points of use, free ammonia, and ORP levels) and overlay this with trends in other water parameters, Legionella sampling results, geographic location, and changes over time. Include nitrate and nitrite monitoring to the list of current tests performed (free ammonia) to assess for system nitrification. ‘+ Sampling for Legionella ° Continue to perform representative sampling of the potable water system at least quarterly (or more frequently, as determined by MDHHS) and as needed in response to cases of disease, identification of Legionella in the water, or issues with WMP performance and conduct trend analyses of Legionella culture results. Any evidence of persistence, even at low levels, in a single fixture or device is concerning, When any Legionella is identified, continue efforts to identify the root cause of Legionella growth, jervene as indicated by your investigation, and include that fixture or device in the sampling plan moving forward to ensure that Legionella does not persist at that location. Inform MDHHS about all environmental sampling results within one week of receipt during the period of enhanced environmental surveillance. Retain all L. pneumophila serogroup 1 environmental isolates cultured at SPL (or other ‘consultant's fab) for at least 12 months and submit to Michigan BOL upon request. Engineering or administrative modifications could be required if L. pneumophila ‘serogroup 1 continues to be identified (during which time point-of-use filters should be installed or remain in place). © Cold water ° In addition to hot water, the cold water system should be included in the WMP. As part of the WMP, perform a cold water system hazard analysis to determine if conditions are favorable for Legionella growth and amplification. The hazard analysis should include representative Legionella baseline sampling to determine if certain fixture types (e-g., scrub sinks) or areas (e.g., low water use areas) of the McLaren Flint’s cold water system are prone to Legionella colonization. Expanded Legionella validation sampling, including routine temperature, pH and chlorine monitoring is recommended as part of the WMP. 2Cold water system data should be used in conjunction with hot water system data to validate the effectiveness of the WMP moving forward. © Flushing (© Continue the flushing protocol and include protocol details in the WMP. Use WMP performance data to optimize flushing protocol. © Data management (© Data should inform all WMP team decisions. Some facilities find it useful to track culture and parameter data in a sortable spreadsheet, such as shown in this data template: -de.gov/legionella/downloads/wmy late.xlsx © WMP data visualization (Appendix D, Appendix F, Appendix G) can be used to identify, track, and respond to trends in monochloramine and ORP data. In the specific case of CORP it may serve as an indicator that water quality is changing. * Cooling towers (© Cooling towers require oversight and strong operation and maintenance protocols that, adhere to industry guidance®. Cooling tower maintenance should include regular cleanings and routine circulation should occur to help control system chemistry and reduce the risk of biological growth. Additionally, McLaren Flint staff should respond, quickly to cooling tower equipment malfunctions by conducting necessary repairs. * Other control points (© Include ice machines and drinking fountains in the WMP. See ‘Immediate control measures’ above for additional sampling recommendations. ‘© Include point-of-entry cold water filters in the WMP. © Continue to maintain and mor wep. F the remaining decorative fountain as, MDHHS * Follow-up with McLaren Flint to determine how monochloramine system alarms and ORP levels are being monitored, communicated, and documented and that appropriate responses occur. ‘+ Inan effort to improve the understanding of the distribution and diversity of legioneliae in the Mclaren Flint water system, continue to process environmental isolates for molecular sequencing at Michigan BOL. * Continue to communicate with GCHD regarding findings and interventions. Legionelloss guideline: Best practices for control of Legionella Available 23APPENDIX A. Healthcare-associated Legionnaires’ disease: Legionella ecology, epidemiology, and laboratory testing Legionella, a gram-negative bacterium, lives in fresh water, but in the natural environment there are insufficient quantities to cause disease. In large, complex human-made water systems, Legionella can amplify to quantities large enough to cause disease, depending upon the conditions. The following conditions can promote the amplification and potential transmission of Legionella®*: ‘+ Warm temperatures (77-108"F) ‘+ Inadequate infectant ‘+ pH outside range of approximately 6.5-8.5 ‘+ Water stagnation and water pressure changes ‘+ Presence of free-living protozoa ‘+ Presence of biofilm, scale, and sediment in piping + Change water pressure due to construction, water main breaks, or municipal water quality To cause disease after Legionella amplifies, the bacterium must be aerosolized via some device (like a showerhead, sink faucet, cooling tower, hot tub, or decorative fountain}. It must then be transmitted to a susceptible host, typically people who are 50 years or older, smoker, or have weakened immune systems or chronic medical conditions. Legionnaires’ disease is usually acquired by inhaling droplets of water containing Legionella into the lungs. Less commonly, disease occurs by aspirating Legionella- containing water or ice; however, this may be a more prominent mode of Legionella transmission in healthcare facilities, where risk factors for aspiration (e.g, dysphagia) are more prevalent”, compared with other settings. ‘Arreview of 27 Legionnaires’ disease outbreaks investigated by COC during 2000-2014 indicated that almost all were caused by problems preventable with an effective water management program®, a multi-step, continuous process designed to identify areas in a building where Legionella could grow and spread, reduce risk by managing and monitoring the water system, and trigger action when risks are identified. Exposure to a healthcare facility is an important epidemiologic risk factor for Legionnaires’ disease. Healthcare facilites often have large, complex building water systems. They frequently undergo construction and plumbing changes. They often have aerosol-producing devices, such as the ones listed above, as well as other devices unique to healthcare facilities (e.g., respiratory therapy equipment, hydrotherapy tubs, heater-cooler units). Patients in these settings often have clinical risk factors for jonnaires’ disease, such as underiying illness or immunosuppression. While mortality associated with Legionnaires’ disease is approximately 9% overall, approximately 25% of persons who definitely ® coc. Developing a water management program to reduce Legionelle growth and spread in buildings. Avalable at: mw. cde gov of toot Stout J, Yu VL Legionellosis. N Engl Med 1997; 3370}: 682-7 2 Garrison LE, et al Vial Signs: Deficiencies in Environmental Control dentfed in Outbreaks of Leglonnsies’ Disease — North ‘America, 2000-2014. MMWR 2016;65:576-8 Fyacquired the infection from a healthcare facility die of the disease. This difference may be explained, in part, by the inherent vulnerability of the people served by these facilities. CDC's review of Legionnaires’ disease outbreaks indicated that 33% of the outbreaks, 57% of outbreak-associated cases, and 85% of outbreak-associated deaths were associated with healthcare facilties™. Accordingly, CDC has developed recommendations for performing a full public health investigation of healthcare facilites to ensure that the potential risk for Legionella growth and transmission at the facility has been minimized. ‘According to the legionellosis case definition developed by the Council of State and Territorial Epidemiologists (CSTE/**, a patient must have clinically compatible illness (i.e., evidence of clinical or radiographic pneumonia) and a confirmatory diagnostic test to meet public health criteria as a confirmed case of Legionnaires’ disease: ‘© By culture: isolation of any Legionella organism from respiratory secretions, lung tissue, pleural fluid, or other normally sterile fluid * By detection of L. pneumophila serogroup 1 antigen in urine using validated reagents ‘© Byseroconversion: fourfold or greater rise in specific serum antibody titer to L. pneumophila serogroup 1 using validated reagents on specimens collected three-six weeks apart ‘The most commonly used diagnostic test for Legionnaires’ disease is the urinary antigen test (UAT). ‘While UAT has the advantage of rapid turnaround time, the test can only detect L. pneumophila serogroup 1 (which accounts for the majority of cases in the United States). Culture of a lower respiratory specimen for Legionella allows for detection of all species and serogroups, and enables ‘comparison of clinical and environmental isolates to confirm potential sources of exposure. Serological assays can be nonspecific and require paired sera collected at acute onset to two weeks after symptoms and three to six weeks later and thus are not recommended in most situations. In healthcare facilities, COC typically recommends that a full investigation for the source of Legionella be performed when: #21 case of definite healthcare-associated Le isease (a case in a patient who spent the entire 10 days prior to onset of iliness in a healthcare facility) is identified, or + 22 cases of possible healthcare-associated Legionnaires’ disease (cases in patients who spent a portion of the 10 days before symptoms began ina healthcare facility) are identified within 12 months of each other. However, where there is a history of Legionnaires’ disease cases possibly associated witha facility and there is concern that a potential risk for Legionella transmission stil exists, investigating even a single 2 Soda EA eta. Vital Signs: Health Care-Associated Legionnaires’ Disease Surveillance Data from 20 States and a Large ‘Metropolitan Aes — United States, 2015. MMWR 2017;66(22):584-9 % Gacrison Lf, etal Vital Signs: Deficiencies in Environmental Control identified in Outbreaks of Legionnaires’ Disease — North ‘America, 2000-2014, MMWR 2016;65:576-84 CSTE. Position Statements. Avallable at: htps://cdn,ymaws com/wow cst ors/resource/tesmar/PS/09-10-45.odf CDC. Developing a water management program to reduce Legionella growth and spread in buildings. Available at f ‘tof cde.gov/egionela/downloads/toolkit. pot 7 COC. Things to Consider: Healthcare-associated cases and outbreaks. Available at: tns://yww.cdgov/lesionella/heslth: depte/healthcare-resources/cases-outbreaks htmlsfullinvesigaion 25case of possible healthcare-associated Legionnaires’ disease is prudent. Also note that, while the incubation period for Legionnaires’ disease is most commonly two to 10 days from the time of exposure to symptom onset with an average of five to six days*, public health officials have reported incubation periods up to 26 days under rare circumstances™. For surveillance purposes, public health officials. collect exposure histories for the 10 days before date of symptom onset. However, in outbreak settings, ‘where its important to consider a wide range of possible sources, use of a 14-day range (or more) may be adopted by the public health agency leading the investigation, CDC recommends testing of al patients at risk for Legionnaires’ disease with healthcare-associated pneumonia for Legionelfa with both culture of a lower respiratory specimen (e.g., sputum, bronchoalveolar lavage) for Legionella and Legionella UAT. This includes inpatients with pneumonia with onset 2 48 hours after admission as well as patients being readmitted with pneumonia who have had ‘exposure to that particular facility in the 10 days (or longer, as described above) before symptom onset This process is crucial for detecting additional cases of healthcare-associated Legionnaires’ disease associated with a healthcare facility Egan R, Halli, Lemon Di, Leach S. Modeling Legionnaires’ dsease outbreaks: estimating the timing of an aerosolized release using symptom-onset dates. Epidemiology 2011;22(2)188-98 2 Fraser DW, Tsai TR, Orenstein W, etal Legionnaires’ disease: description ofan epidemic of pneumonia. N Engl Med 1977;297(22):1389-97. 26APPENDIX B. Order, Michigan Department of Health and Human Services: issued June 12, 2019 S STATE OF MICHIGAN GRETCHEN WHITMER DEPARTMENT OF HEALTH AND HUMAN SERVICES ROBERT GORDON covERKOR LANSING ‘RECTOR ORDER REQUIRING MCLAREN REGIONAL MEDICAL CENTER IN FLINT TO CORRECT CONDITIONS ‘The Michigan Department of Health and Human Services (the “Department” or “MDHHS") has a duty “to prevent the spread of diseases and the existence of sources of contamination.” MCL 833.2226. Further, “[tJo assure compliance with laws enforced by the department, the department may inspect, investigate... any matter, thing, premises, place, person, record, vehicle, incident, or event.” MCL. 383.2241. And, the Department may issue an order to “correct, at the owner's expense, a building or condition which violates health laws or which the local health officer or director reasonably believes to be a nuisance, unsanitary condition, or cause of illness.” MCL 888.2466. The Department also has authority to order the correction of conditions posing an imminent danger to the public health. MCL 333.2251. McLaren Regional Medical Center in Flint (“Mclaren Flint”) has been the subject of Legionnaires’ disease outbreak investigations due to having health-care associated cases of Legionnaires’ disease in multiple years, including 2014 and 2015 (62 cases), 2016 (2 cases), 2017 (1 case), 2018 (3 cases) and 2019 (2 cases to date). In 2018 and 2019 alone, five cases of Legionnaires’ disease were identified as having health care associated exposure as an inpatient to McLaren Flint. One of these cases is a definite health care associated case, as the individual spent ten days at the facility during their disease incubation period. ‘Two of the five health care {889 SOUTH GRANO AVENUE « PO BOX 30196 + LANSING, MICHIGAN 48000 ‘wn clgan govt «617.373.3740, ‘Source: Michigan Department of Health and Human Services 27associated cases have died. In comparison, during this two-year period, no other hospital in the state has had more than three cases with in-patient exposure. Despite best efforts, the Department has been unable to obtain satisfactory assistance from McLaren Flint in investigating the continued occurrence of cases. ‘The Department has attempted to work with McLaren Flint to assure that all appropriate steps are being taken to protect the health, safety and welfare of patients, staff and visitors within the health facility. McLaren Flint has a duty to cooperate with this Department in matters affecting the public health. MCL. 383.2231(1), McLaren Flint also has an obligation to carry out practices to prevent the spread of diseases. MCL 333.21621. But the history of Legionnaires’ disease cases in this facility, coupled with McLaren Flint’s resistance to the Department's public health assurance efforts, leave concerns about McLaren Flint's practices and patient health at the hospital. The Department may assure compliance with laws enforced by the Department, and may inspect, investigate, or authorize an inspection or investigation to be made of any matter, thing, premises, place, person, record, vehicle, incident, or event. MCL 833.2241(1). This Order is issued because the Department has sought assurance of legal compliance from McLaren Flint but not received it, and because the Director has determined a nuisance, unsanitary condition, and a possible cause of illness rising to the level of an imminent danger to the public health exist in this facility. ‘The facts giving rise to the issuance of this Order are as follows: 281. MeLaren Flint was the subject of Legionnaires’ disease outbreak investigations for 2014, 2015, and 2016. Concerns flowing from those investigations led the Department to issue a correction order on February 14, 2017. While there was disagreement between the Department and McLaren Flint regarding the issuance of that order, that disagreement was resolved through a collaboration agreement between the parties that took effect on May 17, 2017. 2, By ite terms, the collaboration agreement expired on December 31, 2017. 8. Following expiration of the collaboration agreement, the Department issued a Close-out Report on July 11, 2018, through which the Department evaluated McLaren Flint’s compliance with the agreement. The Department also articulated concerns about McLaxen Flint’s implementation of its water management plan and offered recommendations for public health assurance improvements. 4, During 2018, three patients at McLaren Flint experienced conditions the Department believes to be Legionnaires’ Disease with a possible association with their stays in McLaren Flint. As McLaren Flint is aware based on its participation in discussions with the Department and the Centers for Disease Control and Prevention (“CDC’), the CDC agrees with the Department's determinations in this regard. Nonetheless, McLaren Flint has disputed the factual determinations related to all three of these patients. McLaren Flint has declined to fully implement recommendations made by both the CDC and the Department on 29how to investigate suspected cases in the future, and on the steps to be taken regarding the water system to better assure public health. 5. During 2018, McLaren Flint also failed to provide timely and complete documentation or information about its corrective actions to address problems (reflected in testing data) arising in its implementation of its water management plan. 6. As McLaren Flint provided poorly scanned testing data, the Department enlisted the assistance of the Michigan Department of Licensing and Regulatory Affairs (‘LARA’) in early 2019 to facilitate the receipt of water system testing data. On February 11, 2019, McLaren Flint provided LARA water system testing data from November 1, 2018 through February 7, 2019. The Department also asked LARA to secure documentation describing McLaren Flint’s process for corrective measures arising from the data, such as Water Management Team meeting minutes and Corrective Action reports described in McLaren Flint’s Water Management Plan, McLaren Flint did not supply documentation. 7. Aveview of the testing data from July of 2018 through February 7, 2019, showed anomalies in the provided data that included evidence of Legionella bacteria in water in patient areas and monochloramine measurements that often fell outside control limits. Because of these continuing anomalies, the Department requested a collaborative agreement through which McLaren Flint would send information directly to the Department, Despite several lengthy communications, efforts to come to such an agreement were not successful. 308 On April 6, 2019, I sent McLaren Flint’s Chief Executive Officer a letter requiring McLaren Flint to provide the Department specified documentation needed for public health assurance purposes. A deadline for providing this material was set for April 10, 2019. 9. On April 10, 2019, Chad Grant, McLaren Flint’s Chief Executive Officer, responded to my letter making various commitments. This letter objected to MDHHS attention to cases associated with McLaren Flint and stated that attention focused exclusively on McLaren Flint biases resulting data against McLaren Flint. McLaren Flint agreed to provide the revised edition of its water management plan when it is completed. Mr. Grant’s April 10, 2019 letter also agreed to make corrective action logs available to MDHHS or the Genesee County Health Department (‘GCHD”) only after a public health investigation of Legionellosis conducted in accordance with MDHHS's “Legionellosis Surveillance and Investigation Protocol”, limiting conditions for public health investigation. Not accepting my request that it provide water system parameter testing data on a routine ongoing basis, McLaren Flint only agreed to provide data for water testing for February and March 2019 only, which Julie Borowski provided under a separate cover on April 10, 2019. In the cover letter to these data, Ms Borowski stated that their expert consultant, Dr. David Krause, felt that overall the data “reflects a water management program that is actively managing the supplemental treatment of its higher risk systems and responding to varying conditions and validation sample results in a rapid, conservative, and effective manner. Sporadic detection of anlow Legionella concentrations does not indicate amplification, nor does it correlate with risk of disease.” CDC has documented the importance of maintaining a high index of suspicion for healthcaye-associated LD, even in the setting of a long-term disinfection program (Demirjian A, Lucas CE, Garrison LE, et al. Clin Infect Dis. 2016; 60:1696-602). 11, Meanwhile, during 2019, two more Legionnaires’ disease cases with association to McLaren Flint have been reported. This means that, during 2018 and 2019, five cases of Legionnaires’ disease were identified as having health care associated exposure as an inpatient to McLaren Flint. One of these cases is a definite health care associated case, as the individual spent ten days at the facility during their disease incubation period. Two of the five health care associated cases have died. In comparison, during this two-year period, no other hospital in the state has had more than three in-patient cases with this exposure. 12, Two of the 2018 and 2019 cases had Legionella bacteria from their Jungs available for genetic testing, including the 2019 definite health care associated case. These cases with exposure to McLaren Flint during the incubation period are highly similar genetically to environmental samples taken from water in McLaren Flint between 2016 and 2019, from both hot and cold-water systems. ‘These Legionella are also highly genetically similar to Legionella from four other patients with health care associated exposure to McLaren Flint from 2008, 2016 (2 cases) and 2016. 32218. On May 10, 2019, MDHHS recommended to McLaren Flint that, due to the definite health care associated case of Legionnaires’ disease, immediate water restrictions were needed in F Building, as well as notification of risk to current patients and patients discharged from impacted areas of the facility since April 21, 2019. Ms Borowski shared a patient notification on May 10, 2019 that did not adequately notify patients to the potential Legionella exposure at McLaren Flint. MDHHS has provided suggestions and templates for patient notification that have been disregarded by McLaren Flint. 14. On May 10, 2019, McLaren Flint also stated that it would not be able to pull a report of past discharged patients and begin mailing notices until the following Monday. MDHHS issued a press release on May 10, 2019, disclosing to the public that MDHHS is investigating a case of Legionnaires’ disease in a patient at McLaren Flint and alerting people to signs and symptoms of the disease and that people with pneumonia should be tested for Legionnaires’ disease if they were recently hospitalized. On Wednesday, May 15, 2019, Ms Borowski informed MDHHS that McLaren Flint would not be restricting water usage or sending notification to previously discharged patients at this time, as no Legionella was detected in water from locations where that recent patient had stayed, and they felt the MDHHS press release advised the public of ongoing issues with Flint water. 15. Ina June 5, 2019 email to LARA, Chad Grant, McLaren Flint CEO said he welcomed the involvement of CDC but then attempted to set conditions for a public health investigation. McLaren Flint requested that the visit occur duringnormal business days, limiting the time of the investigation to three days. They also required that CDC or MDHHS provide a written report to McLaren Flint within 80 days of the completion of the site visit, CDC will provide a report to MDHHS once the work is completed and cleared review. McLaren Flint also attempted to restrict the use of the information obtained as part of this visit. McLaren Flint also tried to set conditions regarding MDHUHS ability to inform the public about this visit or the findings from this visit. McLaren Flint’s approach to this CDC site visit is consistent with its past efforts to restrict the public health assurance activities generally, and the CDC specifically. During a CDC and GCHD site visit on August 25-26 of 2016, McLaren Flint also placed time and location restrictions on CDC's ability to investigate a health care associated case in that facility. CDC was advised of these restrictions in a letter from Cline, Cline and Griffin on August 25, 2016. Although CDC and GCHD staff were given one day to take samples from areas where the patient had stayed, the agencies were only able to conduct a limited environmental assessment of other areas of the McLaren Flint facility and could therefore only collect a few representative points to describe the water management system. If additional time had been available, CDC and GCHD would have expanded the environmental assessment to include additional control points and inspection of all cooling towers, decorative fountains, whirlpool therapy spas, and ice machines, which is usual investigation practice. 3416. Rooms, drinking fountains, and ice machines in McLaren Flint have continued to test positive for Legionella on multiple occasions. McLaren Flint has stated these levels of positivity are to be expected, but repeated positive tests in water systems serving patients who later became sick with Legionnaires’ disease is an indicator of health risk. On these grounds, I reasonably believe McLaren Flint’s water system is a nuisance, in an unsanitary condition, and a possible source of illness rising to the level of being an imminent danger. Acting on this reasonable belief, I, under the authority granted by sections 2241, 2251 and 2455 of the Public Health Code, order McLaren Flint to comply with the following: 1, McLaren Flint shall immediately implement and maintain water restrictions for patients in areas used by health care associated Legionnaires’ disease cases, as directed by the Department, including water restrictions on the fifth floor of B/C building. Water restrictions, including those currently in place on all floors of F tower served by monochloramine unit one, will be maintained until MDHHS, in consultation with CDC, states the imminent threat from building water system has been mitigated. a, Water Restrictions include: i, Restricting showers (using sponge baths instead); ii, Avoiding exposure to jetted tubs; iii, Installing 0.2-micron biological point-of-use filters on any showerheads or sink/tub faucets intended for use; 351, Understand and comply with manufacturer's recommendations regarding the temperature, pressure, and chemical levels that filters can withstand and suggested frequency for replacement. iv. Provision of an alternate potable water supply for patients; v. Any other potential source of patient exposure that are identified during the investigation; 2, McLaren Flint shall immediately notify current patients and all patients discharged since April 21, 2019 of potential exposure to Legionella at this facility, symptoms of Legionnaires’ disease and recommendations to seek immediate care if symptomatic, using notification templates already provided by MDHHS. McLaren Flint shall provide the Department written confirmation this has been accomplished by 5:00p.m. on June 14, 2019. 8, McLaren Flint shall provide MDHHS complete test results with raw data for all water tests including, but not limited to, bacteriologic, temperature, pH, monochloramine, chlorine residuals, and free ammonia testing within seven (7) days of testing. Results should be provided for a period not less than twelve (12) months for purpose of public health investigation into the source of Legionella exposure in the facility. This twelve-month investigatory period will reset following the diagnosis of a definite health care-associated Legionnaires’ disease case or a second possible health care associated case. 36Data for period April 1 to June 7, 2019 shall be provided by Friday June 14, 2019. McLaren Flint shell perform an evaluation of trends in water quality and testing measures over time, particularly in response to incident Legionnaires’ disease cases and also for areas occupied by patients with healthcare associated Legionnaires Disease in the past. , McLaren Flint shall continue to identify and remediate underlying issues (Gxtures, systemic) that are the source of the persistent positivity and continuation of associated cases. . McLaren Flint shall allow MDHHS and cooperating public health agencies such as the CDC to conduct a public health investigation of the health threat. ‘This shall include unfettered access to: a. the facility to conduct a risk assessment and test water quality parameters, water and biofilm samples at any locations deem to be appropriate by the Department in the public health investigation. b. records and appropriate staff to assess current implementation of the facility's water management plan and enhanced clinical surveillance. . McLaren Flint will preserve isolates from all positive Legionella results from clinical and environmental testing in accordance with MDHHS and CDC recommendations. Isolates from environmental samples are needed to assess the genetic variability of Legionella within the facility's system. All isolates that result from this testing must be promptly shared with MDHHS using 37shipping method as described in attached “Legionellosis Guidance for Clinicians” from MDHHS. 8 McLaren Flint must provide DHHS with all information requested by the Department related to Legionella, its water system, the revision and implementation of its infection control protocols, and the revision and implementation of its water management plan. McLaren Flint shall also promptly comply with all requests for information related to its investigations, evaluations, and responses to Legionnaires’ disease cases. 9, McLaren Flint must carry out the recommendations from the Department, the CDC, and the GCHD to assess and reduce risk of Legionnaires’ disease in its facility. ‘This ORDER IS EFFECTIVE IMMEDIATELY. Date: June 12, 2019 obey Robert Gordon, Director Michigan Department of Health and Human Services 38APPENDIX C. Order, Michigan Department of Licensing and Regulatory Affairs: issued June 12, 2019 & STATE OF MICHIGAN GRETCHEN WHITMER DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS ORLENE HAWKS ‘GOVERNOR. LANSING DIRECTOR, June 12, 2019 In the Matter of: McLaren Flint Chad M. Grant, President and CEO 401 South Ballenger Hwy Flint, MI 48532 ORDER Conditions at McLaren Flint Hospital concerning low level persistence of Legionella bacteria in the McLaren Flint Hospital's water system has come to the attention of the Department of Licensing and Regulatory Affairs (DLARA). Steps taken by McLaren Flint (“the Facility”) to date are not sufficient to resolve these issues that impair the ability of the Facility to deliver an acceptable level of care and services for the health, safety and welfare of the public, Therefore, after review I find, as the Director of the Michigan Department of Licensing and Regulatory Affairs (DLARA), that additional steps must be taken by the hospital to ensure compliance with the Public Health Code, 1978 PA 368, MCL 333.20101 ef seg., as amended, related to the persistent level of Legionellosis and the continued identification of healthcare associated Legionnaires’ disease cases. Findings: This Order is based upon the Michigan Department of Health and Human Services’ (MDHHS), Communicable Disease Division, Ongoing Legionellosis Investigation, MeLaren Flint Hospital (dated June 10, 2019). The MDHHS investigation report is included as Attachment A. ‘The MDHUS investigation makes findings related to Legionellosis that includes, among other items: five cases of Legionnaires’ disease with health care associated exposure at McLaren Flint Hospital were reported to public health officials in 2018 and 2019; review by the Centers for Disease Control and Prevention (CDC) and MDHHS review of all medical records attached to the case files entered into the Michigan Disease Surveillance System by Genesee County Health Department (GCHD) supports the assertion that these five cases represent Legionnaires’ Disease (LD) cases with exposure histories that classify them as possible (4) and/or definite (1) health care association with McLaren Flint Hospital. 611 W. OTTAWA +P.0, BOX 30004 » LANSING, MICHIGAN 48909 ‘wor michigan govlara » 817-373-1820 ing and Regulatory Affairs Source: Michigan Department of LiAs a result of MDHHS’s investigation and this report, MDHHS recommended the following non-inclusive steps be taken: - immediately impose water restrictions for patients (filters or reduction in patient water use) on all areas serviced by the impacted monochloramine unit (F tower, floors 4 and up), - advise current and recently released patients (as of April 1, 2019) of potential exposure, symptoms of Legionnaires’ disease and recommendations to seek immediate care if symptomatic, ~ evaluate trends in water quality and testing measures over time, particularly in light of Legionnaires’ disease cases, and - continue to identify and remediate underlying issues (fixtures, systemic) that are the source of the persistent positivity and continuation of associated cases. MDHHS further recommended a facility evaluation by subject matter experts from the CDC, which would include unfettered access to review records, assess cutrent implementation of the facility water management plan, and to obtain water and biofilm samples from the facility at any locations the CDC deems to be appropriate. MDHHS anticipated the Facility’s good faith cooperation with the recommendations and site evaluation by the CDC team. However, efforts by DLARA to secure the Facility’s full cooperation have not been successful. Thus, in light of dangers to current and future patients posed by the Legionellosis reviewed in the DHHS investigation and report, and pursuant to the DLARA’s authority under the Public Health Code, 1978 PA 368, ef. seq., DLARA makes the following findings: 1, The DLARA has the obligation and authority to “[pJrotect the health, safety, and welfare of individuals receiving care and services in or from a health facility... [.]” MCL 333.20131(1)(a) 2. The DLARA has the further authority “to control communicable diseases” and can “take immediate action necessary to protect the public health, safety, and welfare of individuals receiving care and services in or from a health facility or agency.” MCL 333.20132(2), 3. The Facility has the mandatory obligation to “cooperate with the department in carrying out its responsibility under this article.” MCL 333.20151. 4, The Facility has the further mandatory obligation to provide DLARA with “access to books, records, and other documents maintained by a health facility .. . to the extent necessary to carry out the purpose of” Article 17 of the Public Health Code. MCL 333.20155(17). 405. The Facility also “shall endeavor to carry out practices that will further protect the public health and safety, prevent the spread of disease, alleviate pain and disability, and prevent premature death.” MCL 333,21521. 6. The Facility further must “assure that the hospital develops and maintains a plan for biohazard detection and handling.” MCL 333.21513. 7. The Public Health Code authorizes the DLARA to issue an order concerning a licensee's operations according to the Code’s requirements, MCL 333.20162(6). Considering the foregoing findings, and based on the MDHHS investigation report, it is hereby ordered that: ORDER Now therefore, pursuant to the DLARA’s foregoing statutory authority and McLaren Flint Hospital’s statutory obligations and duties, and in light of the Public Health Code’s clear intent that i isions “be liberally construed for the protection of the health, safety, and welfare of the people of this state.” MCL 333. it is hereby ordered that: 1. McLaren Flint shall immediately implement and maintain water restrictions for patients in areas used by health care associated Legionnaires’ disease cases, as directed by the Department, including water restrictions on the fifth floor of B/C building. Water restrictions, including those currently in place on all floors of F tower served by monochloramine unit one, will be maintained until MDHHS, in consultation with CDC, states the imminent threat from building water system has been mitigated. a. Water Restrictions include: i. Restricting showers (using sponge baths instead); . Avoiding exposure to jetted tubs; . Installing 0.2-micron biological point-of-use filters on any showerheads or sink/tub faucets intended for use; 1. Understand and comply with manufacturer’s recommendations regarding the temperature, pressure, and chemical levels that filters can withstand and suggested frequency for replacement. iv. Provision of an alternate potable water supply for patients; v. Any other potential source of patient exposure that are identified during the investigation. 2. MeLaren Flint shall immediately notify current patients and all patients discharged since April 21, 2019 of potential exposure to Legionella at this facility, symptoms of Legionnaires’ disease and recommendations to seek immediate care if symptomatic, using notification templates already provided by MDHHS. McLaren 3 aFlint shall provide the Department written confirmation this has been accomplished by 5:00p.m. on June 14, 2019. }. McLaren Flint shall provide MDHHS complete test results with raw data for all water tests including, but not limited to, bacteriologic, temperature, pH, monochloramine, chlorine residuals, and free ammonia testing within seven (7) days of testing, Results should be provided for a period not less than twelve (12) months for purpose of public health investigation into the source of Legionella exposure in the facility. This twelve-month investigatory period will reset following the diagnosis of a definite health care-associated Legionnaires’ disease case or a second possible health care associated case. Data for period April | to June 7, 2019 shall be provided by Friday June 14, 2019. McLaren Flint shall perform an evaluation of trends in water quality and testing measures over time, particularly in response to incident Legionnaires’ disease cases and also for areas occupied by patients with healthcare associated Legionnaires’ disease in the past. .. McLaren Flint shall continue to identify and remediate underlying issues (fixtures, systemic) that ate the source of the persistent positivity and continuation of associated cases. . McLaren Flint shall allow MDHHS and cooperating public health agencies such as the CDC to conduct a public health investigation of the health threat, This shall include unfettered access to: a, the facility to conduct a risk assessment and test water quality parameters, water and biofilm samples at any locations deem to be appropriate by the Department in the public health investigation, b. records and appropriate staff to assess current implementation of the facility’s water management plan and enhanced clinical surveillance, McLaren Flint will preserve isolates from all positive Legionella results from clinical and environmental testing in accordance with MDHHS and CDC recommendations. Isolates from environmental samples are needed to assess the genetic variability of Legionella within the facility’s system. All isolates that result from this testing must be promptly shared with MDHHS using shipping method as described in attached “Legionellosis Guidance for Clinicians” from MDHHS. . McLaren Flint must provide DHHS with all information requested by the Department related to Legionella, its water system, the revision and implementation of its infection control protocols, and the revision and implementation of its water management plan. McLaren Flint shall also promptly comply with all requests for a2information related to its investigations, evaluations, and responses to Legionnaires? disease cases. 9. McLaren Flint must carry out the recommendations from the MDHHS, the CDC, and the GCHD to assess and reduce risk of Legionnaires’ disease in its facility. This ORDER IS EFFECTIVE IMMEDIATELY. Conclusion: 1, This Order is issued under the authority provided to the DLARA under the Public Health Code including, but not limited to, the statutory provisions cited above. 2. This Order does not relieve the McLaren Flint Hospital, owners, officers, directors, employees and/or agents from any requirement under state or federal laws or regulations governing hospitals or similar health facilities. 3. Nothing in this Order shall be construed to limit the Michigan Department of Licensing and Regulatory Affairs’ authority, or that of any other state entity or department, to take additional action or issue further orders based upon on-going investigations. Pursuant to MCL 333.20162(7) and 333.20168, the Facility may request a hearing within 5 days of the issuance of this Order. This Order is made and dated this 12" day of June 2019, in Lansing, Michigan. Orlene Hawks, Director Michigan Department of Licensing and Regulatory Affairs 8ATTACHMENT A INTEROFFICE MEMORANDUM TO: LARRY HORVATH DIRECTOR, LARA BUREAU OF HEALTH CARE FACILITY LICENSING FROI JIM COLLINS DIRECTOR, MDHHS COMMUNICABLE DISEASE DIVISION SUBJECT: ONGOING LEGIONELLOSIS INVESTIGATION, MCLAREN FLINT. HOSPITAL. DATE: JUNE 10, 2019 ce: SARAH LYON-CALLO, MDHHS BUREAU OF EPIDEMIOLOGY ROBERT GORDON, MDHHS DIRECTOR DR. JONEIGH KHALDUN, MDHHS CHIEF MEDICAL EXECUTIVE ORLENE HAWKS, LARA DIRECTOR KIM GAEDEKE, LARA DEPUTY DIRECTOR ‘This memorandum serves as an update on MDHHS engagement with McLaren Flint Hospital regarding cases of Legionnaires’ disease associated with the facility, and to clarify our specific asks of the facility given our concerns about ongoing, MDHHS had recommended that McLaren Flint Hospital provide water restrictions in patient areas of floors 4 through 12 of the F Tower and allow the Centers for Di Control and Prevention (CDC) to conduct an environmental investigation. Iti that McLaren Flint Hospital be cooperative with the site evaluation by this CDC team and that the team be offered unfettered access to review records, assess current implementation of the facility water management plan, and to obtain water and biofilm samples from the facility at any locations they deem to be appropriate. It is also important to re-state that there are public health and safety concerns with low level persistence of Legionella bacteria in the McLaren Flint Hospital’s water system particularly in the context of continued identification of healthcare associated Legionnaires’ discase cases. MDHHS Legionellosis staff review case referrals and local public health response to reported cases of legionellosis, including Legionnaires’ Disease. Records gathered for reported cases in the Michigan Disease Surveillance System are reviewed for timely follow-up, completion and indications of common exposures for cases, including healthcare settings. Responses to identified issues, including investigation into possible healthcare associated cases of Legionnaires’ disease, are coordinated with local publi¢ “ahealth jurisdiction staff. MDHHS staff look for guidance in evaluation of cases and conduct of investigations from the CDC Legionella program (htips:l/www.ede.gov/legionella/index.html) and frequently obtain technical assistance from subject matter experts from that program. Standard protocols promulgated by the CDC include assessment for a full investigation of hospitals that have two or more possible healthcare associations, or one or more definite health care associations, within a twelve-month period ( hitpsu/iwww.cde.gov/legionella/health-depts/healthcare- resources/cases-outbreaks.himl), Investigation includes implementation of enhanced clinical review of cases, full risk assessment and investigatory water testing, possible water restrictions, and identification/remediation of potential source(s) of exposure. During 2018 and 2019, five cases of Legionnaires’ disease with healthcare associated ‘exposure to McLaren Flint Hospital were reported to public health. CDC and MDHHS, staff have reviewed all available medical records attached to the case files in the sigan Disease Surveillance System by Genesee County Health Department (GCHD) staff. That review supports the assertion that these five cases represent Legionnaires’ disease cases with exposure histories that classify them as possible (4) and/or definite (1) healthcare association with McLaren Flint Hospital (see attachment One). Among these five eases with exposure at McLaren Flint, two clinical Legionelia isolates were recovered from patient specimens. Whole genome sequencing (WGS) on these two clinical isolates demonstrated that they were highly similar to a known cluster of environmental isolates collected at McLaren Flint Hospital during 2016-2019 and four other clinical specimens collected during 2008-2016 from healthcare associated case- patients with exposure to McLaren Flint Hospital. Further, environmental specimens collected in 2019 include one collected from an ice machine that was located near the definite healthcare associated case in 2019. These clinical and environmental specimens. were also, genetically, highly similar to each other and the rest of the McLaren Hospital patient and environmental specimens. Overall, this cluster demonstrates not only great similaity within, but also represents a very distinct pool when compared to other Michigan and national isolates. Resultant from these cases and ongoing concerns with persistent, low level positivity of Legionella testing in the hospital water system, MDHHS, CDC, and GCHD have been actively engaged with McLaren Hospital administration and contracted consultants to minimize risk to current and recent patients. The hospital is in process with updating their ‘water management plan, continues to maintain monochloramine secondary water treatment units, has reported to have installed appropriate filters on the fixtures on floors 4-12 of F Building, has imposed limited additional water restrictions while filter installation occurred, and has conducted limited patient notification of current patients and staff, To protect the public against this threat, MDHHS is specifying that: 1) McLaren Flint Hospital shall immediately implement water restrictions for patients in areas used by health care associated Legionnaires’ discasc cases, as directed by public health, including water restrictions on the fifth floor of B/C building. Water restrictions, including those currently in place on floors of F tower served by 45monochloramine unit one, will be maintained until MDHHS, in consultation with CDC, states the source of exposure has been identified and remediated. 8) Water Restrictions include, but are not limited t i) Restricting showers (using sponge baths instead) ii) Avoiding exposure to jetted tubs iii) Installing 0.2 micron biological poi sink/tub faucets intended for use (1) Understand manufacturer's recommendations regarding the temperature, pressure, and chemical levels that filters can withstand and suggested frequeney for replacement iv) Provision of an alternate potable water supply for patients ¥) Restrictions around any other potential sources of patient exposure that are identified during the investigation. ital shall immediately notify all current patients and all patients 21, 2019, using the templates provided by MDHHS, of L-of-use filters on any showerheads or discharged since Apr potential exposure to Legionella, symptoms of Legionnaires’ disease and recommendations to seek immediate care if symptomat 3) McLaren Flint Hospital will provide MDHHS complete test results with raw data for all water tests including, but not limited to, bacteriologic, temperature, pH, monochloramine, and free ammonia testing within seven (7) days of receipt. Results should be provided for a period not less than twelve (12) months for purpose of public health investigation into the source of Legionella exposure in the facility. This twelve-month investigatory period will reset following the diagnosis of a definite health care-associated Legionnaires’ disease case or a second possible health care associated case in a twelve-month period. Data for period April | to June 7, 2019 shall be provided by Friday June 14, 2019. 4) McLaren Flint Hospital shall demonstrate evaluation of trends in water quality and testing measures over time, particularly in response to incident Legionnaires’ disease cases, 5) McLaren Flint Hospital shall continue to identify and remediate underlying issues (fixtures, systemic) that are the source of the persistent positivity and continuation of associated cases. 6) McLaren Flint Hospital shall allow MDHHS, GCHD, and the CDC to conduct a public health investigation of the health threat. This shall include unfettered access to: 8) the facility to conduct a risk assessment and test water quality parameters, water and biofilm samples at any locations deemed to be appropriate by the Department in the public health investigation. b) records and appropriate staff to assess current implementation of the facility water management plan and enhanced clinical surveillance. 7) McLaren Flint Hospital will preserve isolates from all positive Legionella results from clinical and environmental testing in accordance with MDHHS, GCHD and CDC recommendations. Isolates from environmental samples are needed to assess the genetic variability of Legionella within the hospital system. All isolates that result from this testing must be shared with MDHHS using shipping method as described in attached “Legionellosis Guidance for Clinicians” from MDHHS. 468) McLaren Flint Hospital must cooperate with all requests for information from the Department related to Legionella, its water system, the revision and implementation of its infection control protocols, and the revision and implementation of its water management plan, MeLaren Flint shall also comply with all requests for information related to its investigations, evaluations, and responses to Legionnaires’ disease cases. 9) McLaren Flint Hospital must cooperate with recommendations from public health to assess and reduce risk of Legionnaires! disease.