Davita Ivy Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 40430 Based on observation, and interview, nursing staff did not ensure a sanitary environment to minimize the transmission of infectious agents within the unit. Specifically, bloodlines (tubing used to provide hemodialysis treatment) were draped over the top/side of the non-biohazard (waste does not include sharps or heavily soiled items) waste container located in the dialysis stations during the hemodialysis (treatment that cleans blood and removes fluid from the blood) treatment. Findings include: Observation on 08/25/25 from 02:15 PM to 03:30 PM at Station #1 revealed during the hemodialysis treatment, the two blood lines connected to Patient #18’s access and the hemodialysis machine, were draped over the top/side of the non-biohazard waste can located on the floor in the station, next to the dialysis chair. One of the blood lines had a used glove (dirty) that was disposed of in the waste can, on top of the blood line. Interview on 08/27/25 at 12:45 PM with Staff (C), Facility Administrator, verified this finding.”

“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: 40430 Based on policy review, observation, and interview, nursing staff did not perform hand hygiene after removing gloves and/or prior to re-donning of gloves. Findings include: Review of the policy “Infection Control for Dialysis Facilities,” last revised April 2023, indicated all teammates will perform hand hygiene prior to gloving and immediately after the removal of gloves, after patient and dialysis delivery system contact, and before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse. Observation on 08/26/25 at 10:52 AM at Station #18 for Patient #4 revealed Staff (J), Registered Nurse, checked the needle insertion sites for bleeding, removed their gloves, walked over to the cart to retrieve Band-Aids, and reapplied gloves without performing hand hygiene. At 02:40 PM at Station #11 for Patient # 11, Staff (I), Registered Nurse, removed their gloves and walked over to the computer stand at Station #9 to retrieve the thermometer. Staff (I) re-entered Station #11 and re-applied gloves without performing hand hygiene prior to disconnecting Patient #11 bloodlines from their central venous catheter (CVC- tube inserted into a large vein to provide access for hemodialysis) port to discontinue the treatment. Interview on 08/27/25 at 12:45 PM with Staff (C), Facility Administrator, verified the findings.”

“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: 22484 Based on policy review, observation, and interview, the facility failed to ensure personal protective equipment (PPE-equipment worn for protection from workplace hazards such as blood) such as gowns, face shields, eye wear, or masks were worn when performing procedures during which spurting or splattering of blood may occur. Findings include: Review of policy “Infection Control For Dialysis Facilities,” revised April 2023, revealed appropriate PPE will be worn whenever there is the potential for contact with body fluids. Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, physicians/providers, and visitors when in the treatment area. Review of the policy “Personnel Protective Equipment,” dated August 2006, indicated teammates will wear PPE including, but not limited to full face shields or mask and goggles. Observation on 08/25/25 at 11:05 AM at Station #19 for Patient #23 revealed Staff (R), Patient Care Technician, cannulating (inserting needles) Patient #23’s fistula (surgically created access for dialysis) and initiated dialysis treatment. Staff (R) was wearing eye protection/goggles, but their surgical mask was below their nose with their nostrils exposed. Between 02:30 PM to 03:00 PM at Station #9 and Station #10, Staff (R) was observed stripping the machines (removing used blood lines) then cleaning/disinfecting the machines/equipment/stations wearing their surgical mask below their nose exposing their nostrils. Between 03:05 PM to 03:40 PM at Station #1 and Station #2, Staff (R) discontinued the dialysis treatments for Patient #18 and Patient #21, removing needles from fistulas, stripping and cleaning/disinfecting machines wearing their surgical mask below their nose with nostrils exposed. Observation on 08/26/25 at 10:40 AM at Station #18, revealed the adult child of Patient #4 was sitting in a chair facing them while holding the needle insertion sites post treatment, without a gown or any face protection PPE. Interview on 08/27/25 at 12:45 PM with Staff (C), Facility Administrator, verified the findings.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 40430 Based on policy review, observation, and interview, staff do not properly handle and/or immediately dispose of potentially infectious waste. Specifically, staff do not dispose of needles and/or syringes at the point of use. Findings include: Review of the policy “Methods of Compliance,” last revised October 2023, indicated disposable sharps, including but not limited to needles, fistula needles, and other rigid sharp material that has or may have come in contact with blood or bodily fluids, must be discarded as soon as possible into sharps containers (puncture/leak resistant container for disposal of contaminated needles and sharps) that can be closed and are puncture resistant and leak-proof. Sharps containers should be located as close as possible to the immediate work area. Review of the policy “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles,” last revised April 2023, indicated staff are to remove the needle from the fistula and dispose of the safety fistula needle in the sharps container. Observation on 08/25/25 at 11:15 AM at Station #8 for Patient # 1 revealed Staff (J), Registered Nurse, aspirated (withdrew/removed) two 10 milliliter (ml) syringes of blood and placed them on the side table. After Patient #1 was connected to the hemodialysis machine, Staff (J) exited the station to reset a machine alarm at Station #6, and did not discard the two syringes of blood. At 11:20 AM at Station #9 for Patient #16, Staff (I), Registered Nurse, used two five ml and two 10 ml syringes to aspirate blood and flush central venous catheter (CVC- tube inserted into a large vein in the body to provide access for dialysis) ports. After Patient #16 was connected to the hemodialysis machine, Staff (I) carried the used syringes in their hands and walked approximately 10 feet across the unit to dispose of the syringes into a mobile (on wheels) sharps container located near the nursing station/desk across from Stations #9 through #12. At 03:20 PM at Station #1 for Patient #18, Staff (R), Patient Care Technician, removed a needle from Patient #18’s fistula, carried the needle approximately six feet to a sharp’s container located across from Station #3, in the center of Pod #1. Observation on 08/26/25 at 09:40 AM at Station #4 for Patient #25 revealed Staff (P), Patient Care Technician, removed a needle from Patient #25’s fistula and carried the needle approximately six feet to a sharp’s container located across from Station #3, in the center of Pod #1. At 09:45 AM Staff (P) removed the used blood lines from the dialysis machine, carried the lines approximately six feet to a mobile (on wheels) biohazard red garbage can located across from Station #3, in the center of Pod #1. At 09:55 AM at Station #5 for Patient #24, Staff (K), Patient Care Technician, removed a needle from Patient #24’s fistula, carried the needle approximately six feet to the mobile sharp’s container located across from Station #8, in the center of Pod #2. Interview on 08/27/25 at 12:45 PM with Staff (C), Facility Administrator, verified the findings.”

“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: 40430 Based on policy review, observation, and interview, the facility does not ensure expired supplies are not available for use. Findings include: Review of the policy “Residual Minncare HD Testing Using Residual Minncare HD Acid Test Strips,” dated April 2021, indicated staff are to verify the test strips are not expired. The expiration date is printed on the side of the vial. Review of the policy “Infection Control for Dialysis Facilities,” last revised April 2023, indicated expiration dates will be verified prior to use. Review of the “Medication Policy,” last revised October 2023, indicated the facility designee is responsible for handling, storing, disposing and controlling of medications and performs a monthly audit. Observation on 08/25/25 at 10:40 AM in the isolation room revealed two bottles of Minncare Residual Test Strips expired on 01/31/25. At 10:45 AM in the lab room, 17 culture swabs (wound drainage sample swabs) expired on 06/22/25. Interview on 08/25/25 at 11:05 AM with Staff (D), Registered Nurse, verified this finding.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 16136 Based on policy review, observation, document review, and interview, the facility does not ensure that hardness testing is collected after the softener tank (system to remove hardness from water to prevent patient complications during hemodialysis treatment) and the salt level in the brine tank (mixture of salt and water, used to soften water) is above the water level. Findings include: Review of policy “Hardness Test Using RPC Water Hardness Test Strips,” last reviewed September 2015, indicated staff are to flush the post-softener sample port for 30 seconds before obtaining a sample from this location, place the test strip in the sample port for five (5) seconds, shake off any excess liquid, and wait 15 seconds before reading the result. The water sample collection cup is to be rinsed three times after completion of hardness testing. Observation on 08/26/25 at 03:00 PM revealed that Staff (O), Patient Care Technician, obtained a water sample for hardness testing after the secondary carbon tank. The sample should have been taken from the main softener tank. Staff (O) utilized a test strip, placed the test strip in the sample port for five (5) seconds and read the result immediately, not waiting for 15 seconds. Staff (O) did not rinse the water sample collection cup after testing the water hardness. Review of the manufacturer’s recommendations “Mar Cor Purification,” no date, indicated to maintain the salt level (of the brine tank) at or above the water level. Observation on 08/26/25 at 02:45 PM revealed the salt in the brine tank was below the water level. Interview on 08/27/25 at 01:00 PM with Staff (T) and Staff (H), Biomedical Staff, verified these findings.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 16136 Based on observation, policy review, and interview, the facility does not ensure the correct procedure for chlorine level testing of the water utilized for patient hemodialysis treatments. Findings include: Review of the manufacturer’s recommendations “RPC Ultra-low Total Chlorine Test Strips,” no date, revealed staff are to rinse the sample cup prior to obtaining a water sample to ensure that cup is free of any chlorine; swish the test strip in the sample cup according to the temperature in the water room (75-88 degrees Fahrenheit. requires a swish time of 20 seconds); remove the test strip from the sample, shake briskly to remove any excess water; wait 20 seconds for the test strip color to develop, and read. Observation on 08/26/25 at 02:50 PM, revealed Staff (O), Patient Care Technician, performed the chlorine testing on the treated water after the primary carbon tank. The water temperature was 77 degrees Fahrenheit. Staff (O) did not rinse the cup prior to obtaining a 100 ml (milliliter) water sample. Staff (O) swirled the test strip in the sample for 60 seconds and did not wait 20 seconds to allow for the color to develop, reading the result immediately. Interview on 08/26/25 at 03:30 with Staff (B) and Staff (C), Facility Administrators, verified this finding and stated training for chlorine testing had occurred within the past 10 days.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure the hot water return temperature of the Continuous Water Purification (CWP- water purification system for hemodialysis) is 85 degrees Celsius when utilized to disinfect the water system. Findings include: Review of the manufacturer recommendations “The 2012 Mar Cor Purification CWP 100, Model H/S, Revision B,” indicated the return hot water from the distribution loop from the farthest point should be 85 degrees Celsius when using hot water to disinfect the water loop. Review of the “CWP Daily Water Log,” from June 2025 to July 2025 did not include documentation of the hot water temperature during the nightly disinfection of the CWP water loop. Interview on 08/25/25 at 01:00 PM with Staff (H), Biomedical Staff, verified this finding.”

“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: 16136 Based on observation, and interview, the facility does not ensure the regulated medical waste (RMW) was secured. Findings include: Observation on 08/27/25 at 10:10 AM, revealed that the soiled utility room where RMW was stored was not secured, did not have a locking mechanism, and was not constantly monitored by staff when the clinic was operational, to prevent unauthorized entry. Interview on 08/27/25 at 12:30 PM with Staff (Q), Facilities Staff, and Staff (S), Facility Administrator, verified these findings”

“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: 16136 Based on policy review, observation, document review, and interview, the facility failed to maintain the building and building systems to ensure safety and functionality. Specifically: smoke dampers (prevents smoke from traveling through the ventilation distribution system) were not tested when installed, the first year and every six years after; fire doors were not self-closing and have positive latching; and the spray foam insulation was utilized in the rated fire walls was not an approved form of insulation. Findings include: Review of the NFPA (National Fire Proection Association), 72-2010 edition” and “NFPA 25, 2011 edition” revealed the smoke dampers must be tested when installed and one year later, and the sprinkler system must be tested quarterly. Observation on 08/27/25 between 11:00 AM and 01:00 PM, the smoke dampers were present in the fire-rated wall adjacent to the Infectious Disease Department and in the fire-rated wall in the reception area. Review of the “Executive Summary Report,” dated 06/06/24 for the fire alarm system revealed no evidence was found to indicate the smoke dampers were tested. No other documentation was received. Interview on 08/27/25 at 12:30 PM with Staff (Q), Facilities Staff, and Staff (S), Facility Administrator, revealed that the dampers were installed approximately 12-18 months ago. No documentation was not provided to verify that the smoke dampers were tested when initially installed and/or after installation. Observation on 08/26/25 at 03:00 PM, in the water room corridor revealed the entrance fire door and exit fire did not have an automatic closing mechanism on the doors. All fire doors must be self-closing and have positive latching to ensure the doors remain closed in the event of an actual fire emergency per NFPA (National Fire Protection Association), 2010 edition. Interview on 08/26/25 at 03:30 PM with Staff (N), Patient Care Technician, verified this finding. Observation on 08/27/25 between 11:00 AM and 01:00 PM, revealed cables, pipes, ductwork, the fire alarm, and security/computer cables were supported by the sprinkler piping throughout the facility. The supply and return hot water pipes were supported by the sprinkler piping adjacent to the Infectious Disease Department and the supply ductwork was supported by the sprinkler piping in the reception area. Non-system components shall not be supported by the sprinkler piping itself per NFPA 25, 2011 edition. Observation on 08/27/25 between 11:00 AM and 01:00 PM, revealed a dark yellow spray foam insulation was utilized in the rated fire walls to seal penetrations throughout the facility. Some examples of locations were above the ceiling tiles in the reception area and the ceiling adjacent to the Infectious Disease Department. According to National Fire Protection Association (NFPA) 13, the spray foam insulation must be separated from the building interior by a thermal (protects against heat and fire spread) or ignition barrier (prevents materials from catching fire). The spray foam insulation was not separated by a thermal or ignition barrier. Additionally, the facility could not provide information demonstrating ASTM E84 testing (a test to evaluate the ability of a product to limit surface spread of flames over 30 minutes). Interview on 08/27/25 at 11:30 AM and at 01:15 PM with Staff (Q), Facilities Staff, verified this finding.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 16136 Based on policy review, document review, observation, and interview, the facility does not ensure equipment is maintained and operated in accordance with manufacturers recommendations. Specifically, maintenance was not performed on seven of seven oxygen (O2) concentrators (machine that provides supplemental oxygen); the emergency “drench” shower was not tested weekly; the eyewash unit was not maintained; and the glucose quality control testing was not performed on the glucometer (tests blood sugar) every day the monitor is in use. Findings include: Review of the manufacturer recommendations for the O2 concentrators (DeVilbiss, SeQual and Invacare) indicated the cabinet filters are to be cleaned at least weekly. Review of the “Oxygen Concentrator Filter Weekly Cleaning Log,” May 2025 to August 2025, revealed seven of seven O2 concentrator filters were not cleaned weekly. Interview on 08/27/25 at 02:00 PM with Staff (B) and Staff (C), Facility Administrators, verified these findings. Review of the “Weekly Eyewash and Drench Shower Inspection Log,” dated 04/23/25 to 08/23/25, revealed no evidence that the drench shower was tested weekly. The log indicates the emergency shower must be tested weekly. Interview on 08/27/25 at 11:40 AM with Staff (H), Biomedical Staff, revealed clinical staff is responsible for testing the drench shower weekly. Observation on 08/27/25 at 09:25 AM, revealed the eyewash station in POD 3 was not maintained. There was a water leak under the cabinet and water was slow to drain out of the sink basin. The temperature gauge for the eyewash unit had condensation and was not legible.. Interview on 08/27/25 at 12:30 PM with Staff (Q), Facilities Staff, and Staff (S), Facility Administrator, verified these findings. Review of the policy “Blood Glucose Testing,” dated April 2025, revealed quality control procedures are performed and documented every day the monitor is used before the monitor is used for patient testing. The “Quality Control Log” is completed at the time of the quality control test. A new log is initiated every month. Completed logs are filed and maintained for two years. Review on 08/25/25 of the “Glucometer Log,” located in a binder kept in the medication area indicated the last documented quality control testing was performed on 05/31/24. No additional logs for subsequent months were found in the binder. Interview on 08/26/24 at 01:45 PM with Staff (C), Assistant Facility Administrator, verified this finding, indicated the glucometers have been used since, and they could not find any logs after May 2024.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 22484 Based on policy review, document review, medical record review, and interview, the quality assurance/performance improvement (QAPI) program does not ensure that all adverse events are investigated, reviewed, and/or completed by the QAPI team for trends, prevalence, and causes to potentially prevent re-occurrences and improve patient care. Findings include: Observation on 08/26/25 from 01:30 PM to 02:00 PM revealed treatment for Patient #8 was paused, lines were rinsed back, a new dialysis/lines were set up due to a clot in the dialyzer, and treatment was re-initiated. The treatment for Patient #20 was paused, most of the system was lost except some of the arterial line, due air in the lines. A new dialyzer/lines were set up and treatment was re-initiated. Review of the quality assurance “Monthly Facility Event by Location,” report from 02/01/25 to 08/18/25, revealed the following adverse reporting events related to accessing and the functioning of a hemodialysis access: one blood loss less than 500 cc (cubic centimeters), seven instances of clotted dialyzer/access/lines, and eight infiltrations. Review of the facility quality assurance monthly meeting documentation “July 2025 Facility Health Meeting,” which shows collected data and documentation by the team from July 2024 to June 2025 revealed no evidence the team analyzed/trended data and/or implemented a monitoring plan with interventions related to events involving blood loss, clotting of dialyzers/accesses/lines, and infiltrations. Interview on 08/27/25 at 11:10 AM with Staff (B), Facility Administrator, verfied there was no documentation of team discussion, analysis, and/or implementation of corrective actions in the quality assurance reports. No incident reports for Patient #8 and Patient #20 had been submitted yet.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 22484 Based on policy review, document review, and interview, in 1 of 10 health files reviewed, the facility does not ensure all staff have an annual health assessment and proof of vaccination/immunity to Measles (Rubeola), Mumps, and Rubella (Staff A). Findings include: Review of the policy “Teammate Health Monitoring Program,” dated April 2019, revealed teammates will be monitored for infectious diseases according to current guidelines. When required by State/Local Health Departments, teammates will be screened for Measles (Rubeola), Mumps, and Rubella. The Facility Administrator or designee will be responsible for the teammate monitoring program. Review of the health files for Staff (A) revealed no evidence of Measles (Rubeola), Mumps, and Rubella screening and/or testing. Interview on 08/27/25 at 12:15 PM with Staff (B), Facility Administrator, verified these findings.”