Davita St. Mary’s Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 52051 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P) and Manufacturer’s Directions for Use (DFU), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Registered Nurse (RN) to accurately verify the hemodialysis machines’ final dialysate (a solution of pure water, electrolytes, and minerals) pH (acidity) prior to each treatment. If the dialysate composition is incorrect, complications such as minor nausea and fatigue or as severe as metabolic acidosis (a decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, and chest pain) could result. The facility had 33 in-center hemodialysis patients. Findings include: Cross Reference: V 250 - Failure of one of one Registered nurse (RN AA) observed to accurately perform independent testing of the machine’s dialysate pH according to the Manufacturer’s DFU prior to the initiation of patient treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 52051 Based on observation, staff interviews, and a review of records, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 33 in-center hemodialysis patients and four home peritoneal dialysis patients who were receiving dialysis services at this facility. Findings include: Cross References: V 250 - Failure of one of one Registered nurse (RN AA) observed to accurately perform independent testing of the machine’s dialysate (a solution of pure water, electrolytes, and minerals) pH (acidity) according to the Manufacturer’s DFU prior to the initiation of patient treatment. V757 - Failure of the Governing Body to ensure that the facility had adequate number of qualified Patient Care Givers to meet the needs of all patients, to provide safe patient care, and to be in compliance with the minimum state required staff-to-patient ratio of one dialysis caregiver to four 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: 52051 Based on observation, staff interviews, and a review of facility policy and procedures (P&P), it was determined that the facility failed to ensure that one of one Licensed Practical Nurse (LPN BB) observed during initiation of dialysis treatment, maintained aseptic technique and changed gloves when going from a “dirty” area or task to a “clean” area or task during preparation/disinfection and cannulation (needle insertion) of Patient (P) #6’s dialysis access sites. This deficient practice increased the risk for cross contamination and access site infection for P#6. The facility had 33 in-center hemodialysis patients. Findings include: - During observation in the patient treatment floor on 4/9/25 at 10:10 a.m., LPN BB was observed while she prepared to initiate treatment on P#6. LPN BB wore gloves and cleaned/disinfected P#6’s right upper arm dialysis access sites with a single alcohol prep pad that she used for both the arterial (carries blood into the dialyzer) and venous (returns the filtered blood back into the body) needle sites. When finished, LPN BB opened/unwrapped the packs of dialysis needles and gauze while she wore the same gloves (contaminated). LPN BB then cannulated P#6 without removing the contaminated gloves, performing hand hygiene and putting on clean gloves. - During an interview with LPN BB on 4/9/25 at 10:18 a.m., she stated that she was unaware that she had not changed her gloves or performed hand hygiene before cannulation. LPN BB acknowledged this breach in aseptic technique, which could put P#6 at risk of dialysis access infection. - A review of Procedure: 1-04-01E titled, “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” with a revision date of October 2022, showed the following: 11. While maintaining the aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site. Cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out, and allow to dry. 16. Remove gloves, perform hand hygiene and put on clean gloves prior cannulation. - On 4/10/25 at 10:05 a.m., the Facility Administrator was informed of the above findings and no comments were made.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [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-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 52051 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility policy and procedures (P&P), it was determined that the facility failed to ensure that three of three Licensed Nurses (Registered Nurses [RN] AA and Facility Administrator) and Licensed Practical Nurse [LPN] AA), who were present during this observation, immediately and thoroughly cleaned and disinfected surfaces contaminated with visible blood on two of two sharps containers at Pod A (Station (S) 1, S2, S3, and S4). This deficient practice increased the risk for transmission of bloodborne pathogens and other infections from one patient to another in hemodialysis (HD) unit. The facility had 33 in-center HD patients. Findings include: - During an observation in the patient treatment floor on 4/9/25 at 9:20 a.m., both sharps containers at Pod A (S1, S2, S3, S4) were found to have scattered blood splatters on them. One sharp container, situated between S1 and S2, displayed multiple small blood splatters of varying sizes and shapes on one side of its body. The other container, located between S3 and S4, had three dried blood droplets, each approximately one to two inches in size, present on its lid cover. - These sharps containers and trolleys were not cleaned and disinfected between patient use. - During an interview with the Facility Administrator on 4/9/25 at 9:31 a.m., he stated that staff generally clean the sharps containers at the end of the treatment day and added that he would clean the sharps containers after this surveyor showed him the findings. During a tour of the treatment area with the charge nurse (RN AA) on 4/9/25 between 4:15 p.m. to 4:45 p.m., the following was revealed: - There were five small, splattered drops of blood inside the left wing of the treatment chair at S8 and three small drops of blood on the floor under the left wing of the chair. - Inside the right wing of the treatment chair at S10, there were three lines of dried blood ia a dripping form. There were two dime size blood on the floor under the treatment chair. - There were three to four drops of blood on the floor under the treatment chair at S12 and S13. - There were two scattered drops of blood on top of the plastic cover of the sharps containers at S1, S3, S6, S7, and in the Isolation Room (S16). On 4/9/25 at 4:50 p.m., RN AA acknowledged the findings and said she would take care of it. - According to CDC guidelines, failure in environmental cleaning and disinfection has led to the transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floor, sharps containers, patients’ chairs or bed surfaces, dialysis equipment surfaces, etc., especially with blood splatters) must be performed between patient use to prevent transmission of dangerous pathogens. - A review of facility Policy # 1-05-01 titled, “Infection Control for Dialysis Facilities” revised April 2023, showed the following: DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the stations) and prior to returning to clean/designated area or removal from treatment area. iii. Cleaning of visible blood should be performed when first observed.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 52051 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P) and Manufacturer’s Directions for Use (DFU), and review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Registered Nurse (RN) to accurately verify the hemodialysis machines’ final dialysate (a solution of pure water, electrolytes, and minerals) pH (acidity) prior to each treatment. If the dialysate composition is incorrect, complications such as minor nausea and fatigue or as severe as metabolic acidosis (a decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, and chest pain) could result. The facility had 33 ICHD patients. Findings include: During an observation in the Patient Treatment Room on 4/9/25 at 12:00 p.m., the following was revealed - RN AA was observed testing the dialysate pH at Station (S) 3 before the start of Patient (P) #2’s dialysis treatment. RN AA obtained a sample of the dialysate from Hansen sample port (the blue port) of the dialysis machine using a 10 ml (milliliter) syringe, transferred the solution into a disposable 20 ml collection cup, and filled it completely. RN AA then proceeded to dip RPC K100-0117 CT E-Z pH test strip into the solution, swished it back and forth for 20 seconds, removed the strip from the fluid, shook off the excess liquid, and immediately compared the reaction strip to the color chart on the bottle to determine the closest match. - During an interview with RN AA on 4/9/25 at 12:20 p.m., RN AA stated that she swished the strip back and forth while submerging it into the solution for about 30 seconds, removed the strip, and immediately read the result. RN AA also acknowledged that it was done incorrectly after reviewing the Manufacturer’s DFU. - A review of Policy: 1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” revised October 2024, stated: Manual pH testing must be performed prior to each patient’s treatment. - A review of Procedure: 1-21-09 titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips” with latest revision date of February 2024, showed the following: 2. Obtain dialysate sample..., then dip the strip in the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20-25 seconds, compare the color reaction on the strip to the color chart on bottle to determine the closest match... Rationale: Following manufacturer’s directions for use. Retest if the results are not read within 25 seconds. - A review of the RPC K100-0117CT E-Z Chek 6.8- 8.5 pH Test Strips’ manufacturer’s DFU showed the following: Instructions for use: 3. Dip or wet the strip pad for one second with fresh solution to be tested. 4. Briskly shake off excess solution. Compare test results to the color scale on the bottle within 20 and 25 seconds. Retest if the results are not read within the 25-second time frame. According to ANSI/AAMI RD52: 2004, Section 5.6, “Dialysate Proportioning”, it is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. - The Facility Administrator was informed of the above observation on 4/9/25 at 12:20 p.m. The Facility Administrator acknowledged and confirmed that the pH test was performed incorrectly.”

“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: 49321 Based on observation, staff interview, and a review of the Governing Body Bylaws, it was determined that the facility failed to ensure that the building in which dialysis services were provided was sanitary and maintained to ensure the safety of the patients and staff. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Water Treatment Room/Supply Room and one of one Patient Treatment Room. The facility had 33 in-center hemodialysis patients and four home peritoneal dialysis patients. Findings include: During a tour of the facility with the Facility Administrator on 4/9/25 from 3:45 p.m. to 4:15 p.m., the following was observed: In the Water Treatment Room/Supply Room: - The epoxy floor in the Supply Room was covered with deep scrathes and a thin layer of dirt. There were four-wheel cart tire tracks with dirt that led out of the Supply Room into the Water Treatment Room. - There was a 5 x 2-inch chipped epoxy flooring at the center of the floor in the Supply Room. - There were two 4-inch metal electrical receptable metal boxes labeled (B18 and B20) in between the two large acid holding tanks that were covered with white flaky and rust colored substances. - The large acid mixer tank (to the left of the extra-large holding tanks) had a moderate amount of rust-colored substance at the top front and that flowed downward and spread out along the front of the tank. At the top of the tank was a mixing pump that was covered with thick layers of white flaky substance. The steel base under the mixing pump was covered with a rust colored substance. - There was a hose from the acid holding tank #1 (at the ceiling level), that was covered with accumulated white thick crystallized substance. - The brine tank had a thick flaky white crystallized substance around the hose that led to a carbon tank. - The floor around the brine tank was covered with thick white flaky substance. - The drain in the left corner of the Water Treatment Room had a thick accumulation of white and yellowish crystallized substances. - Above the drain was a flexible pipe drain that was connected to a shut off valve. The drain was covered with a thick accumulation of white and yellow substances. - The exit door that led to the outside had a patch of cement missing in front of the door (approximately 3 inches deep, 12 inches long, and 5 inches wide) that allowed light to come through. This had the potential for insects and rodents to enter the building through the gap. In the Treatment Area: - There was one ceiling tile at Station (S) 1, two tiles in front of S2, two tiles at S6, one tile at S14, one tile at S15, and two ceiling tiles in the Isolation Room, that had moderate to large rust-colored stains. - The dialysis wall boxes (frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products) at S10, S11, and S12 had rust colored substance under the bicarbonate port. - The floor at S8, S9, and S10 was covered with a thick white film. - The exit door that led to the parking lot had approximately 36 inches gap that allowed light to come through the gap. The Facility Administrator was notified of the above findings on 4/3/25 at 4:30 p.m., and did not offer comments. A review of the “Governing Body Bylaws” showed the following: 3.6 Physical Environment a. Ensure that the physical environment in which ESRD facilities provide services is functional, sanitary, safe, and comfortable for patients and staff.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 52051 Based on observation, staff interviews, a review of the Food and Drug Administration (FDA) recommendations, and review of facility Policies and Procedures (P&P), it was determined that the facility failed to ensure that three of three Licensed Nurses (Registered Nurses [RN] AA and Facility Administrator) and Licensed Practical Nurse [LPN] AA), who were responsible for administering medications, adhered to facility’s medication policy. This deficient practice increased the risk for medication errors. The facility had 33 in-center hemodialysis patients and four home peritoneal dialysis patients. Findings include: During observation in the treatment area on 4/9/25 between 9:00 a.m. and 12:00 p.m., the following was revealed: In the Medication Preparation Area: - There were ten 10 ml [milliliters) syringes containing heparin for hourly infusion and eleven 5 ml syringes of heparin for bolus infusion that were prepared and labeled with the patients’ names, but they lacked the staff’s initials and the date and time of preparation. - During an interview with the Facility Administrator on 4/9/25 at 9:32 a.m., he stated that the prepared heparin medications on the counter at the medication preparation area, were prepared by RN AA (charge nurse) for second shift patients. The Facility Administrator mentioned that the syringes had been drawn up between approximately 6:00 a.m. and 6:30 a.m. and acknowledged that the labels did not include the staff ‘s initials, the time, or the date of preparation. - During an interview with RN AA on 4/9/25 at 10:00 a.m., it was revealed that she prepared the heparin syringes between 8:00 a.m. and 8:30 a.m. RN AA acknowledged that she forgot to write down her initials, the date, and the time of preparation, and subsequently added those missing details to the labels. - At 10:16 a.m., Licensed Practical Nurse (LPN) BB obtained two syringes (one 10 ml and one 5 ml) of prepared heparin from the medication preparation counter and took them to Station (S) 5. LPN BB administered Heparin in a 5 ml syringe for bolus infusion by intravenous (IV) push to P#6 at S5. LPN BB also attached another Heparin maintenance dose in a 10 ml syringe for hourly infusion to prevent clotting in the extracorporeal circuit (bloodlines and artificial kidney). - During an interview with LPN BB at 10:21 a.m., she stated that she came in from another facility to help put patients on. LPN BB admitted that she did not prepare the heparin and assumed that LPN AA prepared it. In the Medication Drawer #1: - There were three containers (100 capsules each container) of Calcitriol (used for treatment of low calcium) 0.25 micrograms (mcg) per capsule, that expired 9/2024. In the Medication Drawer #2: - Three containers (96 tablets each container) of Calcium Carbonate (Antacid) 750 mg per tablet, that expired 12/2024. The Facility Administrator stated on 4/9/25 at 11:20 a.m., that these expired medications should have been disposed. According to the FDA recommendations dated 2/08/21, drug expiration dates indicate the timeframe during which the product is expected to remain stable. This means it retains its strength, quality, and purity when stored according to the specified conditions on the label. Utilizing expired medications or supplies can pose various potential risks. Once the expiration date has elapsed, there is no assurance that the medication or supplies will continue to be safe or effective. A review of the facility’s Policy: 1-06-01 titled, “Medication Policy” with the latest revision date of October 2023, showed the following: 20. If medications are prepared and administered immediately by the same licensed nurse teammate, they do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, date, time prepared, dose, and initials of the teammate preparing the medication. 30. All medications in the facility are checked monthly for expiration dates. 31. Medications are ordered and replaced prior to expiration. 32. Disposal of expired medications, including all over-the-counter and nutritional product samples, are removed from the treatment and inventory areas and disposed of per state/local regulations. - The facility P&P did not to include that all medications shall be administered by the individual who prepared them.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of records, it was determined that the Governing Body failed to ensure that the facility had adequate number of qualified staff to meet the needs of all patients, provide safe patient care, and to be in compliance with minimum state required staff-to-patient ratios as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, access sites, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure [BP] which can occur when fluid is removed too rapidly), hypertension (elevated BP), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility had 33 in-center hemodialysis patients. Findings include: During observation in the treatment area on 4/9/25 at 9:15 a.m., the following was observed: - The Facility Administrator, who is a Registered Nurse (RN), RN AA, who is the charge nurse, and Licensed Practical Nurse (LPN) AA, were providing dialysis care. - There were 13 patients (P) who were seated at Station (S) 1, S2, S3, S4, S6, S7, S8, S9, S10, S11, S13, S15, S16 and were completing their dialysis treatment. During an interview on 4/9/25 at 9:30 a.m., the Facility Administrator stated one nurse was out with a medical issue and one Patient Care Technician (PCT) took a PTO (paid time off). Stated, he hired another PCT, but she was still in orientation and the Administrative Assistant (AA) who was working, was also a PCT and was helping with vital signs and removing hemodialysis needles. When asked about the time the AA arrived, the Facility Administrator stated he was not sure. An interview with RN AA on 4/9/25 at 9:43 a.m. revealed that RN AA was not assigned to specific stations/area. RN AA stated she goes where she is needed, and she was responsible for everyone in the treatment floor. When asked about the number of patient treatments that were started on the first shift while there were three staff members working, RN AA stated there were 15 patients on the first shift and 15 patients were scheduled for dialysis on the second shift. When asked about the AA, she stated that the AA arrived at 8:00 a.m. During an interview with LPN AA on 4/9/25 at 9:54 a.m., it was revealed that he was not assigned to a specific Pod or certain stations. LPN AA stated there were only four staff members who worked every Monday, Wednesday, and Friday and no one was assigned a certain area because everyone was expected to help with getting all the patients on the dialysis machine. Stated, if teammates are absent like today, with two of our teammates missing, the Facility Administrator will help out but when all four staff are here, the Facility Administrator usually arrives to work around 9:00 a.m. During an interview with the AA on 4/9/25 at 2:42 p.m., it was revealed that she arrived at 8:00 a.m. Stated that she was covering for the full time AA who is off today. She then added that she was only here to cover for the full time AA. When asked which stations were assigned to her, the AA stated, she tried to help as much as possible, but her job is administrative assistant and she should not have patient assignment on the schedule. A review of the “Patient and Teammate Schedule” (names of patients who were scheduled to dialyze each shift and the names of dialysis care givers [nurses and PCTs] who were scheduled to work) from March 17, 2025 through April 7, 2025, revealed that this facility’s days of operation were Mondays, Wednesdays, and Fridays. There were three shifts with 15 patients on the first shift, 15 patients on second shift and three patients on third shift. A review of the actual “Patient and Teammate Schedule” (when patients did not show up for treatment due to no shows/absences or hospitalizations) for the following dates showed: March 17, 2025: - There were 15 patients on the first shift, 15 patients on second shift, and two patients on third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. March 19, 2025: -There were 15 patients on the first shift and 15 patients on the second shift. There was no third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. March 21, 2025: - There were 15 patients on the first shift, 15 patients on the second shift, and three patients on the third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on that day. March 24, 2025: - There were 15 patients on the first shift, 15 patients on second shift, and two patients on third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. March 26, 2025: - There were 15 patients on the first shift, 15 patients on second shift, and two patients on third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. March 28, 2025: - There were 15 patients on the first shift, 15 patients on the second shift, and three patients on the third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. March 31, 2025: - There were 15 patients on the first shift, 15 patients on second shift, and two patients on third shift. - There were two PCTs (PCT AA and PCT BB) and one LPN (LPN AA) who worked on this day per facility timecard. It was documented on the staff schedule that the Facility Administrator would be working on the treatment floor as the RN. April 2, 2025: - There were 15 patients on the first shift, 15 patients on second shift, and two patients on third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. April 4, 2025: - There were 15 patients on the first shift, 15 patients on second shift, and two patients on third shift. - There were two PCTs (PCT AA and PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. April 7, 2025: There were 15 patients on the first shift, 15 patients on second shift, and two on third shift. - There was one PCT (PCT BB), one LPN (LPN AA), and one RN (RN AA) who worked on this day. - The staff schedule showed “W” by the Facility Administrator’s name. During an interview with the Facility Administrator on 4/11/25 at approximately 11:30 a.m., he stated that “W” on the staff schedule meant that he was scheduled to work, and “FL” meant he was scheduled to work on the treatment floor.”