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79-1019 HAUKAPILA STREET

KEALAKEKUA, HI 96750

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation, interviews, and document review, the facility failed to have a proactive approach and effective pest management plan to keep a pest free environment for patient safety. This deficient practice has the potential to affect any patient in the facility.

Findings include:

1) The OHCA received an anonymous complaint on 07/11/2025 regarding an infestation of gnats in the operating room at the Hospital.

2) Reviewed the facility's Event log for the time period of May 1, 2025 to current. There were two reported events of insects. Review of the "Quality Assurance Communication Healthcare Event Reporting Forms," revealed the following:

On 06/23/2025, the Operating Room (OR) reported "A gnat was spotted in the OR1 by the surgical tech (technician)...during a case and I (Registered Nurse) killed it. ...The report indicated the sighting occurred "After the procedure (incision) had already started but before procedure ended (closed)." The staff documented there was a "Break in sterile technique."

On 07/09/2025, the OB (obstetrical) department reported "gnats noted in LR2 (Labor Room) and LR3 alive and dead." The description of the event was "gnats found in overhead lights, infant radiant warmers, window seals, shower, and flooring. Facilities, Housekeeping, CNE (Chief Nurse Executive), Infection Prevention, andNursing Supervisor notified. Rooms closed for terminal cleaning or until advised."

3) Reviewed the Infection Committee Meeting Minutes dated 06/25/2025. The minutes included the "Operating Room Report," which documented the following timeline of events of flying insects in the OR:
- "Week of May 26th. We noticed more than one flying insect in the OR suite over the week. Sightings were random and isolated. Response: EVS (environmental services) was involved and two additional bug lights were installed (one in the OR hallway and one by the entrance to the OR from OB). That gave a total of 3 inside and outside of the substerile area. We continued to monitor with EVS. 5/27- a fly got into the OR and we had to break down the room/delay a case."
- "June 6th. We discovered a cluster of several, small gnats outside OR3. ...Response: OR3 was closed and a barrier was put up to seal off the area outside OR3. The area was treated/sprayed and we were unable to determine the source of the gnats. ...Infection Control, ...and Ecolab (pest management vendor) were all brought into the fold."
- "June 9th- Gnats were still found in the space. Facilities continued regular inspections of the ceiling space and located a crack in the building leading directly outside. The hole was sealed and the area was re-treated. Barriers remained in place and OR3 remained closed."
- June 13th. OR3 reopened.
- "The past two weeks (no specific dates provided): the cluster of gnats still had not reappeared, but we are still seeing insects getting into the unit. We believe they are piggybacking into the unit when doors are opened/closed."
- "Ongoing efforts to mediate the situation include:"
"Daily cleaning. spraying by EVS in stairwell/near hospital entrance."
"Continues inspection by Facilities in ceiling tiles, roof etc."
"Frequent cleaning of OR break room by EVS."
"OR staff ensuring food is not left out in breakroom or in locker room areas."
"Limited traffic between OB and OR."
"An additional Fly Light is being installed in the hallway outside the surgical unit."
"Bleach was poured down the drains in all the sinks on the unit."
"Automatic door "open time" was adjusted (reduced from 12 seconds to 5 seconds)."
"Continued consultation with Ecolab."
"Daily tracking-shows more activity later in the day and gnats seem worse when it rains and locations are random."
"Daily messaging is going out to medical staff to keep them updated in real time."
"SOP (Standard Operating Procedure) is being created to outline our response. for the future."

4) On 07/31/2025 at 11:30 AM, interviewed the Infection Preventionist (IP), who said she was first notified of flying insects in the OR on June 6, 2025. She said it seemed they were getting in from outside in the hallway by OR3. The IP went on to say by June 9, it seemed they figured it out, as they found and sealed a gap in the "expansion joint" of the buildings. On June 19th, there was an email from one of the surgeons that they were still seeing gnats. She said "at one point an email was sent with an extensive list of bulleted things to look at." She said everyone that lived in the area had gnats at home and they were being found throughout the hospital. Additional things put in place included looking at the roof for standing water, decreased traffic going into the OR, a light on the roof was turned off at night, a plastic barrier was put up, and another gap was sealed. There were ongoing assessments of the perimeter and a request was made from Senior leadership for written guidelines.

The IP said she, the Infection Prevention Medical Director (IPMD) and Operating Room Nursing Director (ORD) did exhaustive searches regarding insects in the OR and impact on infection. She went on to say ECOlab was at the facility several times to treat areas. The IP said the draft guidelines were completed and scheduled to go to the next Department of Surgery for approval. When asked if there was any other policy or plan for insect management, she said Environmental Services (EVS) had something.

5) On 07/31/2025 at approximately 01:00 PM, conducted an interview with the EVS Superintendent (EVSS) and Supervisor. The EVSS said she was responsible for the Pest Management Plan. When asked her to summarize the content of the plan and EVS role, she said when an insect is found, the EVS department is contacted. She went on to say their role is to notify Ecolab if necessary, and to terminally clean the area. "When they see bugs, they call me and I call Ecolab." The EVSS said they have a monthly service with Ecolab for inside and outside treatments, and in addition she had called them "three or four times regarding the gnats."

On 07/31/2025 at 02:49 PM, conducted an interview with the IPMD, who said he was first notified of the gnats on June 6. He said there was no formal policy, so all sightings were to be reported to OR Leadership. The IPMD said there was little guidance in the literature and could not locate data of risk in the surgical suite. He said the Chief of Surgery was involved and consensus was to continue monitor and allow the surgeon to determine to proceed with a case or not.

On 07/31/2025 at 03:10 PM, conducted an interview with the Chief Medical Officer (CMO), who was a surgeon. He said on 06/06/2025, gnats were found outside the OR. At that time OR3 was closed and efforts were made to determine the source. He went on to say, cracks were sealed and they gathered best practice. He said there was a surge of insects reported on 06/19/2025, and the activity waxed and waned June through July. The CMO said the decision was made to discourage implants, but that in general the risk was low if mitigation efforts were kept up. He said personally, he chose to inform his patients.

On 07/31/2025 at 03:45 PM, conducted an interview with the Chief Operating Officer (COO), who had oversight of Surgical Services, Facilities and Environmental Services. She said they were using the interim protocol for flying insects in sterile areas, which was scheduled to go to the Surgical Department in September. The COO said they "should conduct regular inspections to identify and address potential entry points for flying insects and other pests." She said there was an immediate reduction of insects after putting construction barrier up, spraying the roof and sealing the expansion joint. All staff were asked to report any sighting, alive or dead, to the manager. The COO said after a lot of discussion, it was agreed that it was "nuance issue," and we weighed the risk of not doing surgery and closing the entire area for terminal clean, over the potential of an unstudied thing (surgical site infection). She said of all the sightings of gnats, they were all outside the OR room, or before a procedure, except one, when an insect was not discovered until someone was already in the OR. She said she recalled Ecolab "basically did everything they could think to do, and was hesitant to do anything overly aggressive. They did not feel it was an infestation." The COO said yesterday they found one (gnat) in the hallway, and none the previous day. She went on to say " The pest control plan should be under the EOC (Environment of Care), with standard maintenance. The COO said in the long term, over the next 12 months, the plan was to move the foliage away from the building to reduce access points.

5) Reviewed the draft,"Interim Protocol for Flying Insects in sterile areas," dated 07/18/2025. The Purpose of the policy was "Established protocols for managing insects (flies, gnats, moths, mosquitoes) and other insects in the Surgical Services Department and specifically inside the OR suites."

Policy background included: "Key points to remember are that the presence of insects in the operating room should never be considered normal and a proactive approach to pest prevention is crucial to maintaining a safe and sterile operating environment. The protocol regarding insects in the operating room (OR) and other sterile areas is to immediately address any pest sighting to prevent contamination and maintain a sterile environment. This includes a rapid response, investigation, and thorough cleaning or pest control treatment of the affected area. The protocol provided steps for immediate staff response.

The protocol included post incident actions, which included, but not limited to:
- "During terminal clean special assessments/investigation as to the potential source of insect penetration should be completed by the EVS and Facilities team. 1. HVAC (heating, vacuum, air conditioning), water intrusion. construction projects and breaches in building, sinks, trash/roof, ceiling spaces, electrical and water penetrations not sealed, fresh air intakes, drains and pooling water. 2. Assessment should also include all adjacent spaces and other hospital departments for similar incidents. 3, Assessment of the following environmental impacts should also be completed. Foliage, parking lot drainage,drainage grates, outside trash moved away from building entrances, dead animals around building, birds' nests, proper rain gutter management, pooling water on roof, roof vent overs and intakes are covered. ..."
- "Review and reinforce pest prevention protocols. 1. Review the facilities pest management program and protocols, including sanitation, exclusion and education for staff on reporting insect sightings ..."
-" Review and reinforce pest prevention protocols. 1. Review the faculties pest management program and protocols, including sanitation, exclusion and education for staff on reporting insect sightings ... 2. Professional pest management may be required to inspect and treat the area, ...or other pest management strategies. ..."

The protocol included "C. Prevention: a. Healthcare facility should have an established and documented integrated pest management program that focuses on prevention, monitoring and control. b. Conduct regular inspections to identify and address potential entry points for flying insects and other pests. Maintain strict sanitation practices throughout the facility to include proper disposal of waste and regular cleaning of ... d. train staff on the importance of pest prevention and how to report insect sightings promptly."

In addition, the protocol included " During any period of heightened insect activity, consistent monitoring and reporting will come from the OR management/Senior leadership....ii. Any incident that would reasonably be considered a "sentinel event," or "near miss (i.e.: insect in the sterile field during a procedure) should be logged in ...event software ... iii. OR manager ...will maintain and track insect activity. iv. COO (Chief Operating Office) ...will coordinate and track mitigation activity. ..."

Reviewed the Policy Reference # 1260, titled "Insect and Vermin (refers to wide scope of organisms, including rodents, cockroaches, termites, bedbugs and more) Containment - Guidelines for Management," last review date 01/25/2022. This was the only current policy that addressed pest management. The owner of the policy was the EVS Superintendent. The purpose statement was "To provide an environment free of potential for injury or infection by insects, vermin or vectors, for patients, visitors, ..." The policy included:
- "Policy ... Appropriate departments are notified promptly, with the management of incidents monitored by the Environment of Care Committee."
- "Procedures: ...5c) Need for additional measures, such as extermination, trap setting, etc. will be recommended to Senior Management by the Environmental Services Director in consultation with the Infection Control Practitioner. ...
...7. Problem management and resolution is monitored in the Environment of Care Committee and Infection Control Committee. ..."

This document provides direction for staff should they see a "Insect or Vermin," and addresses some follow-up, but does not include any mitigation or prevention strategies.

6) Reviewed the Environment of Care (EOC) Committee Minutes from meeting dated 07/30/2025. The agenda included updates to the 1) Environmental Safety Management (Mgmt.) Plan, 2) Security Mgmt. Plan, 3) Medical Equipment Mgmt. Plan, 4) Utility Systems Mgmt. Plan, 5) Fire Safety Mgmt. Plan, and 6) Hazardous Materials and Waste Mgmt. Plan.
The discussion under the Environmental Safety Mgmt. plan read "Environmental safety/hazard incidents - Issues we are having with gnats. We are moving in the right direction as maintenance has setup screens, sticky mats, bug traps and pressure washed areas and cleaned up the landscaping where could have been their breeding area. Some days we get reports of 0 gnats getting in." There were no recommendations and/or follow up documented.

Reviewed the documents provided, which revealed there were two versions of Reference (Ref) # 1191, Version 3 titled "Safety Program Management Plan with last reviewed date of 04/28/2025 and Ref # 1191 Version 4 titled "Environmental Safety Management Plan. Version 4 had a titile change and had not yet been approved. The Version 4 draft included the following:
- "A. Scope 1. The ESMP is designed to address the safety risks the environment ...presents to patients, staff and visitors. The program is also designed to assure compliance with applicable codes and regulations."
- "C. Objectives 1. EOC rounds are conducted regularly of the buildings, grounds, equipment ... and work environment ..." 2. The analysis system for accidents, incidents, and occurrences is used to identify key casual [sic] elements of those incidents, and organizes the information for the Environment of Care Committee. ...7. The ESMP includes inspections of grounds and facilities at least annually."
- "E. Processes of the Safety Program 1. EOC rounds ...d. The results of the rounds are used to create new and revised policies and procedures, identify new hazard surveillance elements ... and indicators and /or short-term mitigation of identified hazards or potential hazards. ...3. On Going Examination of Safety Issues a. The chair of the EOC Committee manages the processes for examining safety issues and distributing resultant information. 7. Grounds and Equipment a. The Facility Director is responsible for managing the hospital grounds ... The facility director is responsible for scheduling and performing maintenance of hospital grounds. ... b. Hospital grounds include lawns, shrubs and trees, ... Contractors or KCH staff does preventive maintenance . Corrective maintenance is performed on an as - needed basis. ..."

The EOC conducts quarterly rounding on departments, and uses the following to document findings: - "EOC Checklist: General EOC Overview" to check specific things such as oxygen cylinders, alarm pulls etc. - "EOC Checklist: Staff NPSG (National Patient Safety Goals/Joint Commission) Knowledge & PHI (Protected Health Information) Surveillance. Staff are interviewed to test their knowledge on several topics. - "EOC Checklist: Medication & Crash Cart Safety." - "EOC Checklist: Patient Room Safety." Included call light, privacy curtains, etc.
EOC rounding did not include any routine inspection for pests, or identification of structural or environmental issues
such as foliage, or shrubs that could potentially contribute to breeding. In addition, EOC staff knowledge check did not include any questions about pest management.

7) Reviewed the Hospital "Performance Improvement -Patient Safety Quality Plan Ref # 1287 last review date 05/18/2025. The Plan included:
- "It is our policy to prevent, minimize, identify and resolve any breakdown in systems and processes that may occur and result in suboptimal patient care and/or safety issues. ..."
- "The CEO (Chief Executive Officer): ...Reports to the Board matters related to performance improvement, quality, risk management, infection control and patient safety. ..."

Review of the "Clinical Quality Meeting" Minutes for June 12, June 26, and July 10, 2025 revealed there was no discussion regarding gnat activity in the facility.

8) Reviewed Ecolab (pest management company) invoices from January 1, 2025 to current. The invoices included the following documentation:

01/06/2025: Monthly service
"Structural concerns that could cause pest problems; Kitchen Area- Interior--hole/gap noted behind dish machine. Splash guard and caulking comin [sic] loose seal to prevent pest entry or harborage."

01/09/2025: Monthly service
"Sanitation issues that could cause pest problems: Exterior Area-- trees/shrubs are contacting the facility creating a path for pests to enter. Trim back this vegetation to eliminate contact."

02/03/2025: Monthly service; Additional service report.
Actions taken: ...Interior treatment for flying insects performed.
"Structural concerns that could cause pest problems; Kitchen Area- Interior--hole/gap noted behind dish machine. Splash guard and caulking comin [sic] loose seal to prevent pest entry or harborage."

02/06/2025: Monthly service
"Sanitation issues that could cause pest problems: Exterior Area-- trees/shrubs are contacting the facility creating a path for pests to enter. Trim back this vegetation to eliminate contact."

03/03/2025: Monthly service
"Structural concerns that could cause pest problems; Kitchen Area- Interior--floor drains in need of cleaning. Please clean in and around drains frequently to help prevent breeding sites."

03/05/2025 Monthly service
"Sanitation issues that could cause pest problems: Exterior Area-- trees/shrubs are contacting the facility creating a path for pests to enter. Trim back this vegetation to eliminate contact."

04/04/2025 Monthly service
Sanitation issues that could cause pest problems: Exterior Area-- trees/shrubs are contacting the facility creating a path for pests to enter. Trim back this vegetation to eliminate contact."

04/07/2025 Monthly service
"Structural concerns that could cause pest problems; Kitchen Area- Interior--hole/gap noted behind dish machine. Splash guard and caulking comin [sic] loose seal to prevent pest entry or harborage."

05/01/2025 Monthly service
"Structural concerns that could cause pest problems; Kitchen Area- Interior--hole/gap noted behind dish machine. Splash guard and caulking comin [sic] loose seal to prevent pest entry or harborage."

05/20/2025 Monthly service
"Sanitation issues that could cause pest problems: Exterior Area-- trees/shrubs are contacting the facility creating a path for pests to enter. Trim back this vegetation to eliminate contact."

06/06/2025 Monthly service
"Sanitation issues that could cause pest problems: Exterior Area-- trees/shrubs are contacting the facility creating a path for pests to enter. Trim back this vegetation to eliminate contact."

06/06/2025 Second Invoice
Additional Actions taken: "...Inspected OR rooms for gnat entry points. ...pest activity found during this service.
Conditions found/Actions taken: Roof -Exterior -Gap at the bottom of roof entry door needs to be sealed. Please address structural concern."

06/09/2025 Service: Interior insect.
Actions taken: Inspected OR for gnats. Pesticide applications were made to the following room (s)/area(s) Spot treated hallway loading dock for gnats." Escorted by EVSS.

07/02/2025
"Sanitation issues that could cause pest problems: Exterior Area-- trees/shrubs are contacting the facility creating a path for pests to enter. Trim back this vegetation to eliminate contact."

07/07/2025 Second Invoice
"Sanitation issues that could cause pest problems: Exterior Area--excess water noted. Very damp areas throughout the entire property. Keep area dry. Reduce plant watering to help eliminate pest infestations."

07/17/2025
Actions taken: "Exterior areas was treated for control of gnats."

Ecolab invoices identified multiple times that the vegetation was an issue that could cause a pest problem, as well as some kitchen issues. There was a lack of evidence that the facility addressed these issues in a timely manner.

9) On 08/01/2025 at 09:00 AM, during an interview with the Facilities Director (FD), he said EVS was responsible for the pest management plan and worked with Ecolab for services. He said he had done one walk around with the Ecolab representative who made some recommendations regarding the grounds for pest control. When inquired what kind of routine or preventive maintenance was done to areas that may contribute to pests such as cutting back shrubs, power washing areas of the building including the roof, he replied they had "recently done work, but it is on an as needed basis." The FD did not know how many times Ecolab had been called by EVS, outside the monthly visit, for pest issues. A request was made for work orders related to the issue.

Review of work orders provided included:
- July 2, 2025 and July 30, 2025: "Pressure wash 1st floor roof"
- July 9, 2025: "Cleaned out gnats and wiped down lens from surgical light covers in Rm 2,3,6, & 7."
- July 14, 2025: "mats installed inside or (OR) door inside pacu (post anesthesia care) office and both locker rooms (to mitigate any gnats on people's shoes)."
- July 16, 2025: "removed gnats and cleaned lights in labor rooms 123, and 5"

Later received a typed document from FD listing mitigation efforts facilities did related to the insects. The list included:
"6/05 installed additional bug light in OR"
"6/09 ...found gap in expansion joint above the ceiling in the storage between OR3 and OR2, he sealed from the inside"
"7/7 sprayed area around generator for weeds and cleaned any potential moss off the concrete"
"7/9 sealed the expansion joint from the outside to ensure there was no gap"
"7/9 placed sticky mats at entrances to OR"
"7/9 cleaned lights of gnats in OB"
"7/11-7/18 cleaned roof to remove any possible le organic matter that would be a breeding ground for insects"
"7/14 installed screen over elevator entrance in the ambulance bay"
"7/15 sealed all gaps in ceiling tiles as needed"
"7/21-7/23 installed additional bug light"
"Other items addressed throughout: Checked and replaced filters as needed in AHU's, verified exhaust fans working as designed, removed vegetation that may have been contributing to favorable breeding conditions, repair and inspect any potential water sources above ceiling in the OR suite, multiple inspections,completed by facilities for potential abatement and sources of contribution to breeding and food sources."
Hand written on the document was "Other mitigation includes:"
- "List from EVS"
- "Closed breakroom/removed trash cans"
- "Limited access to hall by 'closing' stairwell entrance by OR, and access points between OB/OR to reduce potential sources"
- "Increased trash removal and increased cleaning."

10) On 08/01/2025 at approximately 09:30 AM, interviewed the Operating Room Director (ORD) and the OR lead. They said they have kept a daily log to track and trend the activity of the insects. The ORD said they provide a report to the surgeon of the recent activity, and the surgeon makes the decision to do the case or not. He went on to say there were only two times an insect was found in the OR Room when a patient was in it, and these two events should have had an event reports made. At that time reviewed the event reports with the ORD, and confirmed that there was no report for the 06/20/2025 event. Reviewed the report of the 06/23/2025 report, and the ORD agreed it lacked important details of where specifically the insect was found and what immediate actions were taken. Although a request was made for the number of cases canceled or delayed, the data was not received prior to survey exit.

Reviewed an email communication from OR Director to COO dated June 27, 2025 at 09:06 AM, that read "...They are seeing a large number of gnats in MS2 (medical/surgical inpatient unit) ..." The ORD said that area of the MS unit is fairly close to the OR.

Reviewed the OR log of pest activity, which included, but not limited to the following entries:
- 06/18/2025: OR3 (inside OR), Case moved/delayed, 1 gnat, Room open, no pt (patient)
- 06/20/2025: OR3 (inside OR), Case in progress, 1 gnat, landed on sterile field
- 06/23/2025: OR1 (inside OR), Case in progress. no comment recorded
- 07/01/2025: OR hallway, outside OR3, 1 beetle like bug, found dead on mayo (small procedure table) stand
- 07/04/2025: Outside OR3, 15 gnats dead and alive, maintenance called in to investigate
- 07/05/2025: OR3 (inside OR) and hallway- all over ..., 30 ish dead and alive, Maintenance sealed off OR3 and hallway of OR 3
- 07/7/2025: OR charge station, led room, 10-20 dead and alive, canceled dental cases ...OR remained sealed. ..."
- 07/07/2025: Scheduling office, 15 dead, ...Maintenance is working on it outside ..."
- 07/08/2025: OR suite in the equipment room, 6 gnats, 3 alive
- 07/08/2025: Break Room, 5 gnats, 1 dead
- 07/09/2025: inside OR3, 1 live gnat, MD aware as it it his room, room shut down to be terminally cleaned, delaying his last case.
- 07/10/2025: inside all OR's, 6 total, was told this morning that they found gnats overnight in all the OR's, they were terminally cleaned after. ..."
- 07/11/2025: there were seven separate entries on 07/11/2025, with locations that included: OR suite hallway , outside of OR1, OR3 subroom, pre-op hallway by HUC office, cart in hallway by preop 3 and 4, Procedure room, OR chart area, a total of 10 live gnats
- 07/12/2025: outside of OR3, and equipment room, 5 live gnats. MD canceled all of his cases due to last weeks gnats.

11) Reviewed a communication thread between the COO and the EVSS,which included: July 10, 2025 COO asked EVVS: "Can your teams please assist with morgue as well?" July 11, 2025 EVSS to COO: "Yes, ..., we will be cleaning up any dead gnats first thing in the morning, I also gave her (staff) a spray bottle to spay any gnats she sees flying around."
July 11. 2025 EVSS to COO: " I've been doing morning rounds daily, spraying any live gnats found in the basement, stairwells, and entrances. there wasn't much activity this morning. ..."

12) On 08/01/2025 at approximately 10:00 AM, toured the OR entrances and area with the OR Director and lead. Observed several of the mitigation strategies put in place, that included, blocked off entrance from OB to OR with tape (can access in emergency), blocked off entrance from locker room from hallway, insect lights installed in OR hallway, sign regarding no open food in break room, and sign limiting stairwell use, and the screen installed in front of the elevator by the ER entrance. Observed one dead gnat on the tape of one insect trap.

On at 08/01/2025 at approximately 10:30 AM, escorted the Quality Director (QD) to an area located near the elevator, off the Emergency Department ambulance entrance, where had previously observed green growth on the ground. The QD agreed the area needed to be cleaned.

13) The facility's response to pest management was focused on monthly treatments from Ecolab and responding when something was found, rather than a proactive approach. The plan was not effective and did not include 1) adequate preventive maintenance, 2) routine inspections internal and external to include foliage and drainage 3) an organized method to track overall insect activity and mitigation activities, 4) Staff education, or 5) monitoring of the amount of pesticide used.











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