032579 Sun Lakes Dialysis (Fmc)

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 37489 Based on review of the facility’s Emergency Preparedness Testing Requirements, record review and staff interview, it was determined the facility failed to participate in drills as required. Failure to participate in drills may lead to untrained staff in an emergency situation and may result in harm to the residents during an emergency. Findings include: Review of the Emergency Preparedness documents on 11/14/2024 revealed that the facility conducted a facility-based exercise table top power loss drill on 07/26/2023. Review of the Emergency Preparedness documents on 11/14/2024 revealed that the facility conducted a facility-based exercise table top active shooter drill on 09/27/2024. The facility Emergency Preparedness binder did not contain evidence of participation in a full-scale exercise (FSE) that was community based in the last two cycles. Employees #1 and 2 confirmed on 11/14/2024 that the facility had not participated in community-based drills as required.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1. (3) of (3) dialysis chairs were appropriately cleaned and disinfected; 2. (1) of (3) dialysis machines were free of dried blood splatter. Failure to thoroughly clean and disinfect the dialysis station poses a potential risk for infection through cross contamination and contact transmission of potentially infectious bloodborne organisms between patients at the station. Findings include: 1. and 2. The facility policy titled “Cleaning and Disinfecting the Dialysis Station” requires: “...The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors...a dialysis station must be cleaned and disinfected between dialysis patients...Dialysis station...Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment...The dialysis station could become contaminated with blood and other body fluids during treatment...Follow the steps below to disinfect the dialysis station after each dialysis treatment...Use a cloth wetted with...disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine...)...Place the chair in Trendelenburg position and open side panels if chair has swing open sides so all surfaces of the chair are accessible. Clean all surfaces...Give special attention to the cleaning control panel on the dialysis machine and other surfaces that are frequently touched and potentially contaminated with patient’s blood and/or body fluids...Pick up all trash or visible medical debris from around the patient chair....” 1. Observation on 11/12/2024 revealed that staff did not open the side panels on the dialysis chairs at stations #1, 12, and 13 when cleaning and disinfecting between patients. Staff member set up the station for the next shift of patients without cleaning the inside of the chair sides. Employee #1 confirmed on 11/12/2024 that staff did not open the sides of chairs when cleaning and disinfecting the station as required by policy. 2. Observation on 11/12/2024 revealed that there was residual dried blood splatter on the front of the machine at station #1 after the station had been cleaned and disinfected and set up for the next patient. Employee #1 confirmed on 11/12/2024 that staff did not follow policy and procedure when cleaning and disinfecting the dialysis machine between patients.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1. staff removed dirty gloves after initiating vascular access cannulation disinfection and retrieving additional supplies from a clean medication cabinet; and 2. staff changed gloves and performed hand hygiene between clean and dirty task while performing a catheter (CVC) dressing change procedure. Failure to follow established standard and infection control precautions poses an increased risk of infections for immunocompromised patients through contact transmission and cross contamination. Cross reference tag V143 for item #2 Findings include: 1. and 2. The policy titled “Personal Protective Equipment” requires: “...Staff must remove gloves and wash hands after: Patient care...Exposure to blood and body fluids...Touching any surfaces within the patient station...If hands are not visibly soiled, an alcohol-based hand sanitizer may be used. Always perform hand hygiene after glove removal....” Observation on 11/12/2024 revealed Employee #32 preparing to clean, disinfect, and cannulate Patient #6’s vascular access. Employee #32 cleaned and disinfected the arterial and venous cannulation sites, left the dialysis station without removing the dirty gloves, retrieved a can of “CryoDose” topical anesthetic from the medication cabinet at a central med prep area, and returned to the patient at Station #13. Employee #32 used the anesthetic spray and continued with the cannulation of the patient’s vascular access without removing her gloves, performing hand hygiene, and donning a new pair of gloves. Employee #1 confirmed on 11/12/2024 that Employee #32 did not removed dirty gloves and perform hand hygiene after leaving the dialysis station and retrieving supplies and before continuing to provide patient care. 2. The policy titled “Changing the Catheter Dressing Procedure” requires: “...Inspect and remove old dressing...Discard dressing and remove gloves. Perform hand hygiene...don clean gloves...disinfect the exit site...allow to dry...apply a dressing to the exit site....” Observation on 11/12/2024 revealed Employee #22 performing CVC dressing change at station #7. Employee #22 did not remove his gloves after removing the patient’s old dressing and applying skin antiseptic to the CVC exit site. Employee #22 applied the betadine, allowed it to dry, and placed a new dressing without changing gloves or performing hand hygiene. Employee #1 confirmed on 11/12/2024 that Employee #22 did not change gloves and perform hand hygiene as required in the facility policy for dressing changes.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 37489 Based on review of policy and procedure, observation, and interview, it was determined that the facility failed to ensure staff don personal protective equipment (PPE) correctly when providing patient care at dialysis stations which has the potential risk for cross contamination and infection. Findings include: The policy titled “Personal Protective Equipment” requires: “...a full face shield or mask and protective eyewear with a full side shield...will be worn...when performing procedures during which spurting or spattering of blood might occur....” Observations on 11/12/2024 revealed the following staff not wearing face masks and/or eye protection correctly. Employee #22 did not wear eye protection during cannulation process on patient #5, nor did the staff member properly don his face mask. The face mask only covered Employee #22’s mouth. Employee #16 did not wear eye protection while assessing Patient #3 while the patient’s fistula needles were being accessed by the technician, nor did she have a face mask that covered both her nose and mouth during assessment. Employee #1 confirmed on 11/12/2024 that Employees #16 and 22 did not wear eye protection and their face masks as required.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1. staff cleaned and disinfected their stethoscopes between and after use on multiple patients which poses a potential risk of increased infection for patients through contact transmission and cross contamination of pathogenic organisms that may be harbored on the dirty stethoscope; and 2. staff clean and disinfect YubiKey security key lanyards between multiple patients and patient stations. Findings include: 1. and 2. The facility policy titled “Cleaning and Disinfecting the Dialysis Station” requires: “...The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between used...Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease...Dialysis station...General Cleaning...After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station....” 1. Observation on 11/12/2024 revealed Employee #13 remove a stethoscope hanging around her neck to do a post assessment on patient #11. Employee #11 placed the stethoscope back around her neck after use on the patient, washed her hands, then returned to chart at the nurse’s station computer without disinfecting the stethoscope. After Employee #13 finished charting she walked to Station #5 to assess the patient and used the dirty stethoscope on Patient #12. Employee #13 returned to chart at the nursing station desk and removed the dirty stethoscope and placed in on the desk. Observation on 11/12/2024 revealed Employee #16 use her stethoscope to assess Patient #3. Employee #16 used an alcohol prep pad to wipe the diaphragm and ear pieces on the stethoscope then hung it around her neck. Employee #16 then walked to station #10 and assessed the patient using her stethoscope. Employee #16 used an alcohol prep pad to wipe the diaphragm only on the stethoscope and placed it around her neck after use. Observation on 11/12/2024 revealed Employee #19 using a stethoscope to assess Patient #3’s vascular access prior to cannulation. Employee #19 hung the stethoscope around her neck after use and once the patient was cannulated and dialysis treatment was started, walked to her work station and placed the stethoscope on the desktop without disinfecting it. Employees #1 and 2 confirmed on 11/13/2024 that staff did not disinfect their stethoscopes with bleach solution as required after use. Additionally, Employee #2 confirmed that alcohol prep pads are not acceptable to be used to disinfect the stethoscopes after use. 2. Observation on 11/12/2024 revealed Employees #13, 16, 17, 19, 22, and 32 had long lanyards either hanging around their neck or attached to the front of their fluid resistant gowns. The lanyards contained the employee’s ID name badge and their YubiKey security key for authenticating medical record entries. All staff were observed for a period of two hours while providing patient care to grab the lanyard with dirty gloves, place it beside the YubiKey scanner on the side of patient machines after documenting in the patient’s chairside record and move to the next adjacent machine and repeat the same process. This was observed multiple times during the two-hour observation that staff touched multiple items in the patient station, touched the patient, and handled the lanyard to authenticate their medical record entry before moving on and doing the same activities with a different patient. No staff were observed cleaning and disinfecting the contaminated lanyard between patients and patient stations. Observation on 11/12/2024 revealed Employee #22 performing CVC dressing change procedure. Employee #22’s lanyard with YubiKey was hanging in the staff member’s work field while removing and replacing the patient’s dressing and while accessing the CVC. The staff member reached up several times with their gloved hand to move the lanyard out of the work field. Employees #1 and 2 confirmed on 11/12/2024 that staff did not clean and disinfect the lanyards attached to their gowns.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff discarded (1) of (1) expired multi-dose medication vial which has the potential risk of patients receiving an expired medication. Findings include: The facility policy titled “Medication Preparation and Administration” requires: “...Labeling vials...When preparing medications if the vial is not used immediately in its entirety, the nurse...must place the date and time the vial was opened on the medication label along with their initials...Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date....” The manufacturer’s directions for use for “Doxercalciferol” requires: “...After initial vial use, store opened multi-dose vial for up to 3 days at 2°C to 8°C (36°F to 46°F). Discard unused portion of multi-dose vial after 3 days....” Observation on 11/12/2024 revealed an open multi-dose vial of Doxercalciferol 4 mcg/2 mL labeled “opened 11/8/24.” Employee #1 confirmed on 11/12/2024 that the open vial of Doxercalciferol had not been discarded when expired three days after opening.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 37489 Based on document review, observation and interview, it was determined that the facility failed to ensure the water room remained restricted to unauthorized users, which increases the potential risk that delicate components of the water system are damaged, compromising the functionality of equipment used to purify water used for dialysis. Findings include: The facility policy titled “Equipment Installation - Operation- Maintenance - Repair - And Disposal” requires: “...Any equipment or device that is not fully functioning in accordance with IFU or company policy, must be repaired or replaced as soon as reasonably possible....” Observation on 11/13/2024 revealed that the water room door was propped fully open with a neon green traffic style cone. There were no staff observed in the area either outside the water room or within the water room. The facility water room contains the facility water system components that are used to make dialysate quality water and acid concentrate. The water room door handle had an integrated locking security keypad. Employee #6 confirmed on 11/13/2024 that the water room was left unsecured and accessible to non-authorized individuals. Observation on 11/14/2024 revealed that the water room door did not latch correctly to prevent unauthorized individuals from opening and accessing the room. Employee #17 demonstrated that the latch for the security door did not engage with the door frame strike plate. Employee #17 demonstrated that the door handle just needed to be pushed to open the water room door. Employees #6 and 17 confirmed on 11/14/2024 that the water room door did not latch properly to prevent unauthorized access.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 37489 Based on observation, document review, and interview, it was determined that the facility failed to ensure a safe and functional environment which poses a risk of adverse patient outcomes. Findings include: Observation on 11/12/2024 revealed with cracked and damaged countertops at each patient dialysis station. The laminate over the countertops behind the patient chair were chipped, lifted, and/or had large sections of missing laminate over the particle board. The facility document titled “Building Interior Physical Environment Inspection” revealed the following issues. 02/20/2024: “ ...Are countertops intact and free from damage allowing cleaning and disinfection?...N ....” 03/12/2024: “ ...Are countertops intact and free from damage allowing cleaning and disinfection?...N ....” 08/19/2024: “ ...Are countertops intact and free from damage allowing cleaning and disinfection?...N ....” 09/04/2024: “ ...Are countertops intact and free from damage allowing cleaning and disinfection?...N ....” 09/18/2024: “ ...Are countertops intact and free from damage allowing cleaning and disinfection?...N ....” 10/28/2024: “ ...Are countertops intact and free from damage allowing cleaning and disinfection?...N....” Employees #1, 2, and 3 confirmed on 11/12/2024 that countertops at the dialysis station were damaged and unable to be thoroughly cleaned and disinfected. Observation on 11/12/2024 revealed cracked, lifted, and missing segments of floor tiles. The flooring around each dialysis station showed signs of tile damage that included severe cracking, separation and lifting of seams between tiles, and in some areas sections of tiles were missing with the subfloor visible through the damaged tiles. Areas in front and behind dialysis machines had water-like damage noted. The facility document titled “Building Interior Physical Environment Inspection” revealed the following issues. 10/28/2024: “ ...Are floors clean, intact and free from damage?...N ....” Employees #1, 2, and 3 confirmed that the flooring around the dialysis stations were damaged and unable to be thoroughly cleaned and disinfected. Observation on 11/12/2024 revealed that all cabinets throughout the clinic were damaged. The cabinet laminate on multiple cabinets was not adhered to the surface and hung freely away from the particle board substrate underneath. Edges around these lifted areas showed expansion and crumbling of the particle board on the corners and ends of the cabinet doors and drawers. Additionally, the cabinet doors in the medication preparation area and at the sinks in the treatment area were not attached and falling off of the hinges. Employees #1, 2, and 3 confirmed on 11/12/2024 that the cabinets throughout the facility treatment area were damaged and in poor condition. Observation on 11/12/2024 revealed a black/brown mold or mildew-like substance underneath the entire inside of the cabinet base of the “clean sink” on the west side of the treatment floor. The facility provided a document from T and M Associates regarding water intrusion and fungal growth assessment. The company provided an assessment for potential water intrusion and fungal growth; however, the assessment was limited to two areas of the facility and did not include an assessment of the mold/mildew-like substance that was observed on 11/12/2024 underneath the entire sink cabinet on the east side of the clinic treatment floor. The report stated that FMC requested an assessment of specific areas only which included the dietician/social worker’s office and the area around stations #8 and 9 on the treatment floor. A policy was requested to address maintenance of flooring, countertops, cabinetry, and potential water and/dialysate damage to the physical environment. The following policy was provided. The facility policy titled “Equipment Installation - Operation - Maintenance - Repair - And Disposal” requires: “...This policy applies to all equipment that: ...has the potential to affect the outcome of patient treatments...This includes but is not limited to: ...medical Equipment...Plumbing Equipment/Systems...Dialysis Chairs...Physical Plant (ceilings, floors etc.)....” The policy did not include verbiage for maintenance of the physical plant. Employees #1, 2, and 3 confirmed on 11/12/2024 that the substance underneath the sink on the east side of the clinic had a mold/mildew-like appearance and that this area of the cabinetry had been replaced at one point for the same issue; however, they did not realize that the same issue still persisted.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure medications were locked when not in use at the medication preparation station. Failure to secure medications when not in use may result in unauthorized access to medication not prescribed to an individual and the potential for tampering or other compromise to the integrity of medications administered. Findings include: The policy titled “Medication Preparation and Administration” requires: “...pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration...All medications will be kept in a locked cabinet except when in use...Securement...All medications will be kept in a locked cabinet except when in use....” Observation on 11/12/2024 revealed two sets of unlocked cabinets at the medication preparation station. The left hand set of unlocked cabinets contained pre-drawn medication syringes, medication cups labeled for individual patients filled with oral medications, and facility medication stock that included oral, topical, and IV medications. The right hand set of unlocked cabinets contained flats of IV Heparin, Xylocaine, and Lidocaine multi dose vials, and Sterile Water single use vials. The right-side door of the “Heparin” cabinet was not attached to the hinges and fell off when opened. Employee #1 confirmed on 11/12/2024 that medications were not locked and secured when not in use.”

“PE-INCORPORATION BY REFERENCE CFR(s): (f) Incorporation by reference. The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov, or go to: www.archives.gov/federal__register/cfr/ibr-locations.html. If any changes in the editions of the Codes are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes. (1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1-617-770-3000. (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11 2011. (ii) TIA 12-2 to NFPA 99, issued August 11, 2011. (iii) TIA 12-3 to NFPA 99, issued August 9, 2012. (iv) TIA 12-4 to NFPA 99, issued March 7, 2013. (v) TIA 12-5 to NFPA 99, issued August 1, 2013. (vi) TIA 12-6 to NFPA 99, issued March 3, 2014. (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011. (viii) TIA 12-1 to NFPA 101, issued August 11, 2011. (ix) TIA 12-2 to NFPA 101, issued October 30, 2012. (x) TIA 12-3 to NFPA 101, issued October 22, 2013. (xi) TIA 12-4 to NFPA 101, issued October 22, 2013. (2) [Reserved] This Standard is not met as evidenced by: 37489 Based on observation the facility did not maintain a comfortable temperature in the Dialysis area which poses a potential risk of patient discomfort and adverse outcomes during treatment. Findings include: NFPA 101: Life Safety Code, 2012 Edition - Chapter 21 Existing Ambulatory Health Care Occupancies1.5.2 Heating, Ventilating, and Air-Conditioning. 21.5.2.1 Heating, ventilating, and air-conditioning shall comply with the provisions of Section 9.2 and shall be in accordance with the manufacturer ’ s specifications, unless otherwise modified by 21.5.2.2. NFPA 99: Health Care Facilities Code, 2012 Edition - Chapter 9 Heating, Ventilation, and Air Conditioning (HVAC) 9.3.1 Heating, Cooling, Ventilating, and Process Systems. 9.3.1.1 Heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities, shall be provided in accordance with ASHRAE 170. ASHRAE Standard 170- 2008 Table 7.1 Dialysis Treatment areas must be maintained between 72-78 deg F. The treatemtn floor temperature was controlled by two thermostats mounted on a pillar in the center of the treatment floor. One thermostat was labeled RTU5 and the other labeled RTU6. Observation on 11/12/2024 revealed that the temperature set on RTU5 at 69.5°F and RTU6 at 69.5°F. Observation on 11/13/2024 revealed that the temperature set on RTU5 at 69.0°F and RTU6 at 68.5°F. Observation on 11/14/2024 revealed that the temperature set on RTU5 at 68.0°F and RTU6 at 70.5°F. Patient #6 made a complaint on 11/12/2024 that the facility is too cold. Observation on 11/12/2024 revealed space heaters in use around the staff offices in the facility. Employees #1 and 2 confirmed on 11/12/2024, 11/132/2024, and 11/14/2024, that the facility temperature is a pre-set range set by the corporate offices in Massachusetts and that the facility has a few degree range in which to adjust temperatures. Additionally, they confirmed that the temperature maintained on the treatment floor was below the required 72° minimum requirment for ASHRAE standard.”