Health inspection·December 3, 2020

F 0700 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few Try different approaches before using a bed rail. If a bed rail is needed, the facility must (1) assess a resident for safety risk; (2) review these risks and benefits with the resident/representative; (3) get informed consent; and (4) Correctly install and maintain the bed rail. Based on observation, record review, and staff and resident interview, the facility failed to ensure 2 (Resident #49 and #165) of 2 residents reviewed for accident hazards were assessed for the need and safe use of bedrails, obtained an informed consent prior to the use of the bed rails, and ensured evaluation for potential entrapment zones. Failure to ensure bed rails were appropriate and safe placed the residents at risk. The findings included: The facility's Policies and Procedure, Subject: Side Rail/Bed rail (effective 4/19/18) listed: 1. Prior to installation of a side rail/bed rail complete the side rail/bed rail evaluation to evaluate the resident for risk of entrapment. 2. Review the risk and benefits with the resident and/or resident representative. 3. Obtain consent from the resident and/or resident representative. The Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment for Industry and Food and Drug Administration (FDA) staff, issued on March 2006, identified the area between the bed rails and mattress; and between the head or foot board and mattress as a risk for head entrapment. Recommendations included caution should be taken when using these products to ensure a tight fit of the mattress to the bed system. (source: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM072729.pdf) 1. On 11/30/20 at 9:57 a.m., Resident #49 was observed sitting in her room in a wheelchair. There were two bedrails observed at the head of the bed. The head of bed was slightly elevated, and a large gap was noted between headboard and mattress. Resident #49 stated she was unaware the rails were there and was unsure what they could be used for. Resident #49 said she had not consented to their placement. On 11/30/20 at 12:41 p.m., Resident #49 stated the bed rails were present on the bed upon her arrival. Review of Resident #49's clinical record revealed no assessment for the safe use of bed rails to include potential entrapment zones. Page 1 of 4 105983 105983 12/03/2020 Harborview Sarasota 4783 Fruitville Road Sarasota, FL 34232

F 0700 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few 2. On 11/30/20 at 9:45 a.m., Resident #165 was observed sitting in his room in a wheelchair. There were two bed rails observed at the head of the bed. Resident #165 stated he was not informed of them and did not consent to their use. He said the bed rails were present upon his admission, and he assumed it was normal for a hospital bed. On 12/1/20 at 3:19 p.m., Resident #165 was observed lying in bed with the right bed rail in the raised position. Review of the admission Data Collection dated 11/14/20 indicated an evaluation for side rails was completed. There was no evidence of a bed rail evaluation having been done in the clinical record. There was no informed consent in Resident #165's chart for the use of bed rails. On 12/2/20 at 10:12 a.m., during an interview with the Assistant Director of Nursing (ADON), she stated an evaluation was to be done for all bed rails and the nurses are to review the risk and benefit of bed rails to obtain informed consent. The ADON said ideally bed rails would not be on beds at the time of admission. The ADON said she kept a list of residents using side rails. She said she was not aware that Resident #49 had side rails. The ADON reviewed Resident #49 and #165's records and confirmed there was no assessment for the safe use of bed rails to include any informed consent for their use. The ADON said she was unsure of who would officially evaluate beds, bed rail fitting, mattresses and entrapment zones. The ADON said maintenance did periodic inspections. On 12/2/20 at 10:32 a.m., Resident #165's bed was observed with the ADON and she acknowledged two side rails at head of bed. On 12/2/20 10:34 a.m., Resident #49's bed was observed with the ADON and she acknowledged two bed rails at head of bed. The ADON placed the bed to flat position and confirmed a gap between head of bed and mattress. On 12/2/20 at 10:42 a.m., the Administrator measured Resident #49's bed from headboard to footboard as 86.75 inches and mattress as 78 inches, creating a possible 8.75-inch gap. He measured the width of mattress as 35 inches, mattress to rail as 3.25 inches, and verified this was an entrapment zone. He said he would get it adjusted. On 12/03/20 11:04 a.m., the Administrator brought the operation and maintenance manuals for Resident #49's and Resident #165's beds. Review of owner's manual for the two beds used in facility both referenced the FDA bed safety guidelines as outlined in https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM072729.pdf). 105983 Page 2 of 4 105983 12/03/2020 Harborview Sarasota 4783 Fruitville Road Sarasota, FL 34232

F 0921 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Many Make sure that the nursing home area is safe, easy to use, clean and comfortable for residents, staff and the public. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation and staff interview, the facility failed to maintain a safe, sanitary and comfortable environment free from bio growth for residents, staff and the public by not having clean surfaces; storing and preparing resident medications in a sanitary environment; and not repairing damaged walls in resident rooms and bathrooms. Not maintaining a sanitary environment has the potential for cross contamination and promotes bio growth. The findings included: 1. On 12/1/20 at 12:30 p.m., review of the facility report date 11/16/20 from ECO Mold Testing, who came onsite to assess 3 areas of concern, revealed the 3 areas identified had high concentrations of Aspergillus, Penicillium, Cladosporium, and Hyphal Fragment Fungi. These tests were achieved by air sampling and tape or swab testing. The areas focused were the Employee Break Room, the Weight Room, and the SSU Nurses Station. All 3 of the locations were observed during the 2:00 p.m., to 4:30 p.m., life safety tour. All 3 areas had signs such as bio growth appearances. Additionally, and not included in the report, the life safety tour revealed similar signs of bio growth in the shower by resident room [ROOM NUMBER], Central Supply, Medical Records, Medical Records Storage, Storage Room next to Medical Records Storage, SSU Nourishment, SSU Medication Room, Dietary Managers Office, and Dry Food Storage. These were mostly located on the ceiling surrounding the air conditioning diffusers and some extruded lighting. Photographic evidence obtained On 12/1/20 at 3:00 p.m., during an interview with the regional life safety coordinator, revealed the facility had not put any interim measures in place from 11/16/20 through 12/1/20 to protect the residents until a remediation company can mitigate all the issues. After surveyor intervention some of the rooms were enclosed with Plastic Sheeting and duct tape to prevent mold spores from migrating out of the affected rooms. The presence of mold in especially high concentrations, can exacerbate immune suppression, respiratory compromise, and allergies in residents, staff and other building occupants, with these conditions. 2. On 11/30/20, 12/1/20, and 12/3/20, during a tour of the facility, the following was observed: room [ROOM NUMBER] - the wall was in disrepair behind the resident's bed. room [ROOM NUMBER] - the resident's wheelchair was heavily soiled with dust and debris; the shared dresser was gouged, viably soiled /heavily stained and missing a handle on one of the drawers; the floor was heavily marred and stained; and a large accumulation of dust was present along the inside vent of the air conditioner (AC) wall unit. room [ROOM NUMBER] 3- the wall was gouged next to the resident's bed; the shared dresser was gouged, viably soiled/heavily stained and missing a handle on one of the drawers; and dust was accumulated along the top of the vents of the AC unit. room [ROOM NUMBER] - the wall behind the toilet was soiled with detached section of drywall; the metal bar behind the toilet was stained; cobwebs were present along the top of the walls and in the 105983 Page 3 of 4 105983 12/03/2020 Harborview Sarasota 4783 Fruitville Road Sarasota, FL 34232

F 0921 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Many corner behind the door; the shared dresser was gouged, viably soiled /heavily stained and the handle was partially detached on one of the drawers; and bio growth was present around the detector in the ceiling. room [ROOM NUMBER] - the shared dresser was gouged, viably soiled /heavily stained with exposed wood near base; there was a large patch of drywall plaster on the wall across from the residents' beds; gouged wall next to resident's bed; a large accumulation of dust was present along the inside vent of the AC unit; the metal bar behind the toilet was stained; and the base of the toilet was heavily stained with black/brown areas. room [ROOM NUMBER] - detached cover with cable hanging loose from hole in upper wall; and gouged walls around room and next to resident's bed. room [ROOM NUMBER] - the wall was gouged behind the resident's bed; the door to the bathroom was gouged; the gout was stained in the shower floor; the light fixture in the shower had a large accumulation of insects inside globe; and the metal bar behind the toilet was stained. The staff bathroom at the SSU unit nursing was in disrepair with stained and peeling walls; heavily soiled/stained floor; heavy accumulation of black debris along cove base; dust and rust present on pipes under hand sink with hole present in wall; wall behind sink had signs of water damage; with brown staining along wall; and heavy corrosion on faucets in sink. On 12/1/20 at 10:48 a.m., the GNR unit medication room was observed along with the GNR Unit Manager. The air vent was heavily coated with bio growth; the refrigerator had several areas of rust present on the side; the hand sink was heavily soiled/stained; the cabinets were soiled/stained with a section of exposed wood near bottom; several of the drawers and doors were stuck and had to be pried open; and the wall cover light switch was partially detached. On 12/1/20 at 11:10 a.m., the SSU medication room was observed along with the Assistant Director of Nursing. The air vent was heavily coated in rust and bio growth was present along the edges; the ceiling was stained brown next to the vent; and there was no soap dispenser or paper towels present by the hand sink. On 12/1/20 at 1:11 p.m., the employee break room was observed. The ceiling was heavily damaged with cracks and detached areas of plaster; and the metal air vents had bio growth present. On 12/3/20 at 9:10 a.m., a tour was conducted with the Administrator and Housekeeping Supervisor. The above room issues were again observed. The Administrator acknowledged the areas of concern and said the dressers were beyond repair and needed to be replaced. The Administrator confirmed he was aware of the areas of bio growth in the facility. *Photographic evidence obtained* 105983 Page 4 of 4