Somatus Dialysis of Mount Vernon

“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: 42725 Based on three (3) infection control observations and document review, it was determined the facility staff failed to follow required infection control and prevention practices related to hand hygiene. Findings: The facility’s policy titled, Infection Control for Dialysis Facilities, under the heading “Staff Members Hygiene” reads, in part: “1. Hand hygiene is to be performed upon entering the facility, prior to gloving, after removal of gloves, ... after patient and dialysis delivery system contact...”. On April 7, 2025, the state agency (SA) conducted observations on the treatment floor from approximately 11:45 AM to 2:35 PM and again from approximately 3:45 PM to 5:00 PM. The observations included, but was not limited to, initiating and discontinuing dialysis treatment, cleaning dialysis stations and administering medication. At 12:08 PM, employee (EMP) 10 was observed removing and discarding gloves without performing hand hygiene prior to donning a new pair. At 12:15 PM, EMP10 was initiating treatment for a patient with a central venous catheter (CVC). EMP10 did not perform hand hygiene between the six (6) glove changes observed. During a CVC treatment initiation at 12:20 PM, EMP8 did not perform hand hygiene between one (1) glove change.”

“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: 42725 Based on two (2) infection control observations and document review, it was determined that the facility staff failed to ensure that after using non-disposable equipment, cleaning and disinfection was performed prior to returning the equipment to the clean area. Findings: The facility’s policy titled, Infection Control for Dialysis Facilities, under the heading “Facility Hygiene” reads, in part: “... 3. Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, cleaned and disinfected before taken to a common clean area or used on another patient...”. During the observations on April 7, 2025 at approximately 12:30 PM, the SA observed EMP7 use a hoyer lift to assist in moving a patient from a stretcher to the recliner. After using the lift, EMP7 returned it to the clean area without cleaning or disinfecting it. The SA returned to the treatment floor at approximately 3:45 PM and conducted additional observations until approximately 5:00 PM. During the observations, the hoyer lift was used on two (2) patients within approximately a seven minute time span. The lift was not cleaned or disinfected between each use.”

“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: 42725 Based on one (1) infection control observations and document review, it was determined that facility staff failed to properly label an open vial of medication. Findings: The facility’s policy titled, Medication Anticoagulation, under the heading “Use of Heparin” reads, in part: ... “9. Each bottle of heparin is marked with the date it is first opened and staff members initials...”. While reviewing the medication preparation area, the SA surveyor observed an open vial of Heparin with no date or initials. The vial had approximately a quarter of liquid remaining.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 42725 Based on observations and document review, it was determined the facility staff failed to maintain asepsis when initiating treatment for two (2) of three (3) patients with a central venous catheter. Findings: The facility’s policy titled, Central Venous Catheter (CVC) Cleaning and Dressing Change, under the heading “Procedure Rationale” reads, in part: ... “6. ... With clean, gloved hands remove old dressing and discard... 7. Assess for infection... 8. Assess CVC at exit site for evidence of cuff migration, cracks, or leaks in the catheter limbs... 9. Remove gloves and discard. Wash hands and re-glove... 10. Holding catheter with nondominant hand, and using aseptic technique, clean exit site with a Chlorhexidine swab... 11. Repeat procedure using a fresh Chlorhexidine swab... 14. Remove gloves and discard. Wash hands and re-glove... 15. Apply sterile adhesive wound dressing over catheter and exit site...”. On April 7, 2025 at 12:15 PM, EMP10 was observed initiating a CVC treatment. EMP10 cleansed the area around the CVC exit site. The patient’s clothing was not secured during the process and fell, touching the cleansed site. EMP10 did not recleanse the site prior to applying a new dressing. At 12:30 PM, EMP9 was observed initiating a CVC treatment. EMP9 cleansed the area around the CVC exit site; the patient’s clothing was not secured during the process and fell, touching the cleansed site. EMP9 did not recleanse the site prior to applying a new dressing.”

“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: 42725 Based on observations, interview, and document review, it was determined the facility staff failed to perform conductivity testing before initiating treatment for five (5) patients. Findings: The facility’s policy titled, Treatment Initiation Utilizing Single-Use Dialyzer and Blood Tubing, under the heading “Procedure Rationale” reads, in part: “1. Verify dialysis delivery system is free of residual disinfectants, has passed all pretreatment tests and is operating free of alarms with correct dialysate concentrates attached...”. The facility’s policy titled, Conductivity Measurement Using the Myron L D-1 Meter, under the heading “Testing Parameters” reads, in part: “The final dialysate conductivity must be tested prior to treatment initiating... For all dialysis programs, 2 staff members will verify the conductivity before treatment...”. On April 7, 2025, while on the treatment floor, the SA did not observe staff perform conductivity testing on the machine prior to the initiation of five (5) treatments. During the observations and review of the water room, the SA inquired about conductivity testing on the machines. EMP4 confirmed that conductivity testing should performed, using the Myron L D-1 meter, prior to the initiation of every treatment.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42725 Based on observations and document review, it was determined the facility staff failed to ensure that a patient’s access site was uncovered and visible throughout the dialysis treatment. Findings: The facility’s policy titled, Intradialytic Treatment Monitoring, under the heading “Note” says: “Patient’s access and face must always be visible”. The facility’s policy titled, Treatment Initiation Utilizing Single-Use Dialyzer and Blood Tubing, under the heading “Procedure Rationale” reads, in part: “... 12. Secure bloodlines to patient. Verify that the access and connections are always visible during the treatment... The access and connections are left visible for ongoing monitoring...”. While conducting treatment floor observations on April 7, 2025 at 1:00 PM, the SA observed the patient a station #7 had their access site covered with a blanket. The SA left the floor at approximately 2:30 PM, the patient’s site was still covered. Upon returning to the floor at 3:45 PM, the SA observed the site remained covered.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 42725 Based on medical record review, document review and interview, it was determined the facility staff failed to acknowledge and address abnormal blood pressure readings during treatment for two (2) of five (5) medical records sampled, MR1 and MR3. Findings: The facility’s policy titled, Pre/Post Dialysis Treatment Data Collection, under the heading “Purpose” reads, in part: “1. Patient data will be obtained and collected by staff members... 3. Findings that may preclude the initiation of dialysis will be reported to the charge nurse immediately. 4. The RN determines the need to intervene and assess the patient immediately or completes the assessment during dialysis and collects any additional data needed... 6. Data collection includes the following: ... Blood pressure... 7. Findings that may preclude the discharge of the patient will be reported to the charge nurse immediately...”. The facility’s policy titled, Intradialytic Treatment Monitoring, under the heading “Policy” reads, in part: “1. Treatment checks should be completed at least every 30 minutes. 2. At a minimum, obtain and document the following: Blood pressure... 5. Significant changes are reported to the licensed nurse and documented. 6. Appropriate action is taken and documented, including patient response... 8. All findings, interventions and patient will be documented in the patient’s medical record...”. Medical record (MR) review revealed the following: MR1 03/28/2025 - Pre-treatment blood pressure (BP) reading was 143/85. Treatment was initiated at 12:14 PM. At 2:30 PM, a BP reading of 156/103 was recorded. At 3:00 PM, the BP reading was 168/103. The post-treatment BP reading recorded was 170/100. 03/31/2025 - Pre-treatment BP was 138/77. Treatment began at 1:03 PM. At 3:30 PM, a BP reading of 169/100 was recorded. The post-treatment BP reading recorded was 183/96. 04/02/2025 - Treatment began at 12:29 PM with a BP reading of 119/67. At 1:30 PM, the BP was 148/93 and at 3:00 PM, the BP was 134/105. The post-treatment BP recorded was 155/106. 04/04/2025 - Treatment began at 12:41 PM with a BP reading of 130/66. At 3:00 PM, the BP was 139/91, at 3:30 PM the BP was 136/90, at 4:00 PM the BP was 148/98, and at 4:12 PM the BP was 146/100. The post-treatment BP recorded was 164/96. 04/07/2025 - Treatment began at 12:41 PM with a BP reading of 144/85. At 3:00 PM, the BP was 165/101, at 4:00 PM the BP was 173/103, and at 4:14 PM the BP was 167/107. The post-treatment BP recorded was 167/103. There was no documentation on the treatment flowsheets acknowledging the elevated BP readings, nurse notification of the elevated readings, or a nursing note post-treatment acknowledging the readings. Additionally, there was no documentation in the medical record indicating on-going management of the blood pressure. MR3 03/19/2025 - Pre-treatment BP reading was 177/101. Treatment began at 7:38 AM with a BP reading of 157/107. At 9:00 AM, the BP reading was 167/101. 03/24/2025 - Pre-treatment BP reading was 177/99. Treatment began at 7:30 AM with a BP reading of 183/103. At 8:00 AM, the BP was 189/102 and at 10:00 AM the BP was 181/100. There was no documentation on the treatment flowsheets acknowledging the elevated BP readings, nurse notification of the elevated readings, or a nursing note post-treatment acknowledging the readings. The SA discussed the findings from the review with EMP2 who acknowledged that staff are expected to document any abnormal findings and notify the nurse.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 42725 Based on medical record review, document review and interview, it was determined the facility staff failed to follow the dialysis prescription for three (3) of five (5) medical records sampled, MR1, MR2, MR3. Findings: The facility’s policy titled, Treatment Initiation Utilizing Single-Use Dialyzer and Blood Tubing, under the heading “Procedure Rationale” reads, in part: “1... Verify patient prescription per procedure...”. The facility’s policy titled, Intradialytic Treatment Monitoring, under the heading “Policy” reads, in part: “1. Treatment checks should be completed at least every 30 minutes. 2. At a minimum, obtain and document the following: ... Blood and dialysate flows, arterial and venous pressures...”. The medical record review revealed the following: MR1 The prescribed dialysate flow rate (DFR) is 600. 04/02/2025 - During the treatment, the DFR was 700 for 2 hours and 30 minutes of the 3 hours and 30 minute total treatment time. There was no documentation indicating the reason for the change. MR2 The prescribed blood flow rate (BFR) is 350 and DFR is 700. The duration of treatment is 3 hours and 30 minutes. 03/26/2025 - The DFR ran at 600 for the full treatment. 03/28/2025 - The DFR ran at 600 for the full treatment. 04/02/2025 - The BFR ran between 300 and 330 for 2 hours of the treatment time. The DFR was 600 for the full treatment. 04/04/2025 - The DFR ran at 600 for the full treatment. There was no documentation indicating the reason for the changes on each treatment day. MR3 The prescribed BFR is 450 and DFR is 800. The duration of treatment is 4 hours. 03/19/2025 - The BFR ran at 400 for 1 hour and the DFR ran at 600 for the full treatment. 03/21/2025 - The DFR ran at 600 for 30 minutes and 700 for the remainder of the treatment. 03/24/2025 - The DFR ran at 600 for 26 minutes and 700 for the remainder of the treatment. 03/31/2025 - The BFR ran at 400 for 1 hour and 30 minutes and the DFR was 700 the entire treatment. 04/04/2025 - The BFR ran at 400 for 1 hour and the DFR was 700 the entire treatment. 04/07/2025 - The BFR ran at 400 for 2 hours and 30 minutes and DFR was 700 the entire treatment. There was no documentation indicating the reason for the changes on each treatment day. The SA discussed the findings from the review with EMP2 who acknowledged that if there are changes to the dialysis prescription during treatment, a reason should be documented.”