Center for Dialysis Care, Warrensville

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 29732 Based on observation, policy review and staff interview, the facility failed to ensure staff removed gloves and wash hands between each patient or station (V113). The facility failed to ensure staff wore face shields, eye wear, or masks to protect themselves when performing procedures during which spurting or spattering of blood might occur, and the facility failed to ensure staff did not drink in the dialysis treatment area (V115). The facility failed to ensure portable equipment was cleaned and disinfected between patients (V116). The facility failed to ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules (V143).”

“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: 29732 Based on observation, staff interview and policy review, the facility failed to ensure staff removed gloves and wash hands between each patient or station for one staff person observed on the treatment floor providing care (Staff N). This could affect all patients receiving services from the facility. The census was 117. Findings include Review of the facility’s policy titled, “Personal Protective Equipment,” effective 12/13/2013, revealed staff were to change gloves after touching a patient or their machine and before arriving to care for another patient or touch another patient’s machine. On 11/13/23 at 6:05 AM Staff N was observed to touch the dialysis machine at station 23, then go to the dialysis machine at station 25, and then return back to the dialysis machine at station 23 without changing her gloves or performing hand hygiene. Interview on 11/13/23 at 6:15 AM with Staff N confirmed this finding. This deficiency represents non-compliance investigated under Substantial Allegation OH00147039.”

“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: 29732 Based on observation, policy review and staff interview, the facility failed to ensure staff wore face shields, eye wear, or masks to protect themselves when performing procedures during which spurting or spattering of blood might occur, and the facility failed to ensure staff did not drink in the dialysis treatment area. This could affect all patients receiving services from the facility. The census was 117. Findings include: Review of the facility’s policy titled, “Personal Protective Equipment,” effective 12/13/2013, revealed protective eyewear is defined as goggles or a face shield that provides shielding from top, bottom, and side as well as front of the eyes. Wear protective eyewear whenever splashes, sprays or droplets may come in contact with the eyes. Change gloves after touching a patient or their machine and before arriving to care for another patient or touch another patient’s machine. Review of the facility’s policy titled, “Universal Precautions,” effective 12/30/2013, revealed eating and drinking is prohibited in the patient care units and nursing stations. 1. Observations were made on 11/08/23 from 5:27 AM to 7:30 AM. At 5:27 AM Staff J was observed to start the dialysis treatment for the patient in Station 14 without a face shield or goggles on. At 5:29 AM Staff L was observed to start the dialysis treatment for the patient in Station 26 without a face shield or goggles on. At 5:30 AM Staff K was observed to start the dialysis treatment for the patient in Station 24 without a face shield or goggles on. At 5:40 AM Staff I was observed to start the dialysis treatment for the patient in Station 4 without a face shield or goggles on. At 5:45 AM it was observed that when staff saw the State Surveyor, they all put their face shields or goggles on. Interview on 11/08/23 at 6:30 AM with Staff B confirmed the staff were not wearing face shields or goggles when putting patients on the dialysis machine. 2. On 11/08/23 at 11:40 AM Staff N was observed to wear a mask below her nose. Staff N confirmed this in an interview at 11:45 AM. At 11:55 AM Staff N was again observed wearing her mask below her nose. Staff N confirmed this in an interview at 12:05 PM. 3. On 11/08/23 at 5:30 AM three drinks were observed to be at the nurses’ station by a computer. Interview on 11/08/23 at 6:30 AM with Staff B confirmed there were three drinks at the nurses’ station. Interview on 11/13/23 at 8:00 AM with Staff G revealed a walk through was made at this facility in July and coffee and food was found at the nurses’ station at that time. Further interview revealed staff did not wear a face shield or goggles or wear their mask over their nose. The Facility Manager was notified several times. This deficiency represents noncompliance investigated under Substantial Allegation OH00147039.”

“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: 29732 Based on observation, policy review, and staff interview, the facility failed to ensure 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. This could affect all patients receiving services from the facility. The census was 117. Findings include: Review of the facility’s policy titled, “Cleaning and Disinfection of External Surfaces and Movable Equipment,” effective 12/30/2013, revealed cleaning and disinfection of any portable equipment (thermometers, stethoscopes) must be performed between patient treatments to prevent cross contamination. On 11/08/23 at 7:07 AM Staff C was observed taking a large blood pressure cuff from station 17, where a patient was receiving treatment, and then use it on the patient in station 7 without cleaning it first. Interview on 11/08/23 at 7:15 AM with Staff C confirmed this finding. On 11/08/23 at 11:50 AM Staff N was observed to use the thermometer on the patient in station 16 and then return it to the clean area without cleaning it. Interview on 11/08/23 at 12:00 PM with Staff N confirmed this finding. On 11/08/23 at 11:56 AM Staff P was observed to use a stethoscope on the patient in station 16 and then on the patient in station 18 without cleaning it between the patients. On 11/08/23 at 12:10 PM Staff B was observed to use a stethoscope on the patient in station 21 and then at 12:25 PM use it on the patient in station 8 without cleaning it between the patients. Interview on 11/08/23 at 12:27 PM with Staff B confirmed this finding. A review of Infection Control audits dated 07/29/23 revealed in eight of eight observations the thermometers and stethoscopes were not disinfected between patients. Interview on 11/08/23 at 1:47 PM with Staff A and Staff F revealed there were no infection control plan of actions currently in place and no follow up plan of action was done from the audit dated 07/29/23. This deficiency represents noncompliance investigated under Substantial Allegation OH00147039.”

“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: 29732 Based on observation, policy review, and staff interview, the facility failed to ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules. This could affect all patients receiving services from the facility. The census was 117. Findings include: Review of the facility’s policy titled, “Medication Preparation and Administration,” effective 01/22/2014, revealed all medications must be prepared just prior to administration and labeled with the name of the medication, dose, date, and time prepared and initials of who prepared the medication. During observations on 11/08/23 at 6:02 AM three syringes containing Heparin were found to be drawn up with no initials, or date or time when drawn up. A syringe was observed to contain a clear liquid, but was not labeled with the name of the medication, date, time or initials of who drew it up. Interview on 11/08/23 at 6:03 AM with Staff K confirmed these findings.”

“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: 29732 Based on observation, policy review and staff interview, the facility failed to ensure patients were in view of staff during hemodialysis treatment to ensure patient safety for five of five patients observed with covered sites (Patient #5, #7, #8, #9 and #10). This could affect all patients receiving services from this facility. The census was 117. Findings include: Review of the facility’s policy titled, “AV Access Cannulation,” effective 11/13/2012, revealed always keep the access uncovered. When monitoring a patient that refuses to uncover their access, educate the patient on the risks of a covered access at least once during the dialysis treatment and document the education and notify the RN. Review of the facility’s policy titled, “Routine Intradialytic Monitoring,” effective 03/17/23, revealed the patient care technician will go to the chair side at least every 30 minutes to monitor the access site is uncovered and secure. Observations were made on 11/08/23 from 7:00 AM to 12:00 PM. 1. At 7:15 AM Patient #7 was observed to have a covered access site. Interview on 11/08/23 at 7:15 AM with Staff I revealed Patient #7 would not keep it uncovered. Review of Patient #7’s medical record and treatment sheet dated 11/08/23 revealed Staff I documented the access was covered and the patient was re-educated; however, no observations were made of Staff I re-educating Patient #7 between 7:00 AM and 12:00 PM. 2. At 7:20 AM Staff I was observed putting oxygen on Patient #8 and then covering the patient and the access site. Interview on 11/08/23 at 7:28 AM with Staff I confirmed this finding. Review of Patient #8’s medical record and treatment sheet dated 11/08/23 revealed Staff I documented at 6:56 AM and 7:26 AM that Patient #8’s access site was visible. 3. At 11:20 AM Patient #9 was observed to have a covered access site. Staff J was observed to answer the machine alarm for Patient #9 and then walk away leaving Patient #9 with a covered site. Review of Patient #9’s medical record and treatment sheet dated 11/08/23 revealed Staff J documented at 11:01 AM and 11:30 AM that the access was visible. 4. At 11:20 AM Patient #5 was observed to have a covered access site. Staff B was observed to talk with Patient #5 and then walk away leaving the access site covered. Review of Patient #5’s medical record and treatment sheet dated 11/08/23 revealed Staff J documented at 10:53 AM and 11:23 AM that the patient’s access site was visible. 5. At 11:40 AM Patient #10 was observed to have a covered site. Staff L looked at the patient and walked away. Review of Patient #10’s medical record and treatment sheet dated 11/08/23 revealed Staff L documented Patient #10 had a covered site and was re-educated; however, no observations were made of Staff L re-educating Patient #10 between 7:00 AM and 12:00 PM. Review of the audits for covered sites dated 09/18/23 revealed five of six patients observed did not have visible access nor was it documented. Four of six patients with covered sites were not re-educated. Interview on 11/08/23 at 2:10 PM with Staff A revealed there was no plan of action documented. This deficiency represents noncompliance investigated under Substantial Allegation OH00147039.”

“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: 29732 Based on observation, policy review, and staff interview, the medical director failed to ensure all policies and procedures relative to patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility for three of eight stations observed with specialty bath containers (station #1, #2 and #8). The census was 117. Findings include: Review of the facility’s policy titled, “Non-Refillable Specialty Bath Cleaning and Storage,” effective 06/26/2019, revealed upon opening a new specialty bath, date, time and initial the container. Do not use if the bath has been opened for >30 days or if the container is opened but not dated or initialed. On 11/08/23 at 12:15 PM dialysate bottles observed at stations 1, 2 and 8 were not labeled with the date and time opened. Interview on 11/08/23 at 12:28 PM with Staff B confirmed this finding.”