Dialysis - Mt Sinai Hosp Med Ctr Renal Unit

“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: 39802 Based on document review, observation, and interview, it was determined that for 4 of 4staff (MD#2, E#1, E#4 and E#14) observed, the Facility failed to ensure that gloves were removed and hand hygiene performed when going from dirty to clean tasks. Findings include: 1. The Facility’s policy titled, “Infection Control Policy - Outpatient Hemodialysis Unit” (dated 12/2024), was reviewed and required, “...Perform hand hygiene: Before and after patient contact... After touching patient’s surroundings... After removing gloves...” 2. During a tour of the dialysis treatment area on 12/16/2024, the following were observed: - At approximately 9:26 AM, a Physician (MD#2) was observed at station #5 checking on a patient. MD#2 removed and discarded gloves after leaving the station and then obtained a new pair of gloves without performing hand hygiene. MD#2 then went to station #4 and started touching the dialysis machine. MD#2 then left station #4, removed gloves and went into an office without performing hand hygiene. - At approximately 9:35 AM, an EVS (Environmental Services) Staff (E#14) was observed checking on the garbage bins at each station. E#14 pushed down the trash in the bin at station #15 with gloved hands. E#14 then moved on towards the end of the hall to check the last station and then touched the door to the waiting room to open it, while wearing the same gloves. E#14 did not remove the gloves and perform hand hygiene as required. - At approximately 11:03 AM, a Patient Care Technician/PCT (E#4) was preparing to discontinue dialysis treatment for a patient. E#4 disconnected the blood lines from the patient’s access, then flushed the access with saline. E#4 then went to grab some new gloves while wearing the same ones used to flush the patient’s access. - At approximately 1:05 PM, a PCT (E#1) was wearing gloves and placed a wrist band on a patient. E#1 then went to place a wrist band on another patient while wearing the same gloves and did not perform hand hygiene. 3. An interview conducted with PCT (E#1) on 12/16/2024, at approximately 2:28 PM. E#1 stated that they should perform hand hygiene after removing gloves and when moving between patients.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 1 of 4 Patient Care Technicians/PCT (E#1) observed providing care for patients, the Facility failed to ensure that equipment were disinfected in between patients. Findings include: 1. The Facility’s policy, titled “Transmission-Based Precautions Guidelines” (revised 11/2024), was reviewed and required, “...When using patient care equipment that cannot be dedicated to the patient room, it is necessary to make sure that the equipment is cleaned and disinfected per manufacturer instructions before leaving... and/or before use on the next patient...” 2. During a tour of the dialysis treatment floor, between approximately 1:00 PM and 2:05 PM, a PCT (E#1) brought a thermometer and phoenix meter (device used to test pH and conductivity of dialysate), to each patient station prior to initiating dialysis treatment. E#1 brought the same thermometer and phoenix meter to the next patient station without disinfecting the equipment in between stations. After E#1 had initiated dialysis for 3 patients, E#1 returned the thermometer and phoenix meter to the nursing station counter (clean area). 3. An interview was conducted with the Nurse (E#6) on 12/16/2024 at 2:32 PM. E#6 stated that all equipment brought to the stations should be disinfected before being used or taken to another patient/station. E#6 stated that they should also be disinfected the equipment prior to returning to a clean area such as the nurse’s station.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 51457 Based on document review, observation, and interview, it was determined that for 1 of 2 Patient Care Technicians/PCTs (E #1) observed for infection control practices, the Facility failed to ensure that protocols were in place to prevent cross-contamination to other patients. Findings include: 1. The Facility’s policy titled, “Infection Control Policy-Outpatient Hemodialysis Unit at (the Facility)” (dated 12/2024) was reviewed and included, “Policy is to establish a comprehensive guidelines and procedure that effectively minimize the risk of infection transmission within the outpatient dialysis facility. The outpatient dialysis facility is mandated to maintain safe environment and minimizing infection risk for patients, staff, and visitors...” 2. During a tour of the dialysis treatment area on 12/16/2024, at approximately 12:51 PM, the PCT (E#1) was at station #18. E#1 was observed using gloves obtained from E #1’s pocket. E #1 then donned gloves and proceeded to provide care of the patient. At approximately 1:05 PM, E#1 then went to station #17 and obtained gloves from their pocket to provide care for the patient. 3. An interview was conducted with the Nurse (E#6) on 12/16/2024 at 2:32 PM. E#6 stated that no supplies should be stored in the staff pockets as it increases risk for cross-contamination between patients.”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 8 of 11 months (January, March-July, September, and October) of microbial monitoring records reviewed for 2024, the Facility failed to ensure that dialysate samples were collected from at least two machines monthly. This had the potential to affect all in-center hemodialysis patients on census. Findings include: 1. The Facility’s policy titled, “Water Quality Monitoring for Bacteriological Analysis and Disinfection Guidelines” (dated February 2023), was reviewed and required, “...Schedule of culture and endotoxin testing [for] ...Hemodialysis Machine: Monthly, rotated among machines so that each machine is tested at least once per year and different machines are sampled on each occasion...” 2. The Facility’s Microbial Records were reviewed from 1/1/2024-11/30/2024 and indicated that dialysate cultures and endotoxins were not done in January, March through July, September, and October. The log indicated that the Facility had a total of 20 dialysis machines. 3. An interview was conducted with the Registered Nurse (E#3) on 12/18/2024, at approximately 9:23 AM. E#3 stated that they tested all the machines in February and most of them again in November. E#3 stated that all machines have to be tested at least annually. E#3 stated that they can start testing 2-3 machines a month.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 2 of 7 months (July and October 2024) reviewed, the Facility failed to ensure that samples for microbial monitoring were collected before sanitization/disinfection of the water distribution system. Findings include: 1. The Facility’s policy titled, “Water Quality Monitoring for Bacteriological Analysis and Disinfection Guidelines” (dated February 2023), was reviewed and required, “...Schedule of culture and endotoxin testing [for] Reverse Osmosis Equipment [water purification/distribution system]: Monthly...” The policy did not include instructions to obtain samples for water cultures/endotoxins before disinfection. 2. The Facility’s Water Culture/Endotoxin Logs from June 2024 to December 2024 were reviewed and included the following: - Cultures were drawn on Tuesday 7/9/2024 at 7:45 AM, the morning right after scheduled disinfection was completed on Monday 7/8/2024 after 9:00 PM (after treatments are completed). - Cultures were drawn on Tuesday 10/1/2024 at 7:25 AM, the morning right after scheduled disinfection was completed on Monday 9/30/2024 after 9:00 PM (after treatments are completed). 3. An interview was conducted with the Registered Nurse (E#3) on 12/18/2024, at approximately 9:23 AM. E#3 stated that they try to draw culture/endotoxin samples at the beginning of the month. E#3 stated that they are only required to draw them within the month and at no specific time of the month. E#3 stated that it would be ideal to draw the cultures/endotoxins before disinfection to so they could determine if there was a breakthrough in the system.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 3 of 12 patients (Pts. #4, #10, and #11) observed, the Facility failed to ensure that access sites were uncovered and visible throughout dialysis treatment. Findings include: 1. The Facility’s policy titled, “Pre-Dialysis, Intra-Dialysis and Post-Dialysis Assessment and Care” (12/2024) was reviewed and required, “...Intra-dialysis: ...Observe lines to access to verify well secured...” 2. During tours of the dialysis treatment area on 12/16/2024, the following were observed: - On 12/16/2024, between approximately 9:23 AM and 11:00 AM, a patient (Pt. #4) was noted to have a blanket covering their access site. At approximately 11:08 AM, a Nurse (E#5) went to Pt. #4’s station and did not uncover the access site or address the covered site with the patient. - On 12/16/2024, between approximately 1:20 PM to 2:30 PM, two patients (Pts. #10 and #11) had blankets covering their access sites. Staff were observed approaching or passing the patients’ stations; however, they did not address the covered access sites. The access sites for both patients remained covered during the tour. 3. An interview was conducted with Patient Care Technician (E#1) on 12/16/2024, at approximately 2:28 PM. E#1 stated that access sites should remain visible throughout treatment. E#1 stated that if a patient covers their access, the staff are expected to uncover the site and explain to the patient that they need to be able to see the access site.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 34411 Based on document review and interview, it was determined that for 3 of 9 (Pt #3, Pt #4, Pt #6) clinical records reviewed, the Facility failed to adjust dry weights (weight without fluid gains), for patients that were not achieving their ordered dry weight. Findings include: 1. The Facility’s policy on fluid management or dry weight was requested. The Facility was unable to provide a policy or a fluid management algorithm. 2. The clinical record for Pt #3 was reviewed on 12/17/2024. Pt #3 was admitted on 5/4/2022 with a diagnosis of ESRD (end stage renal disease). Pt #3’s hemodialysis treatment order (dated 11/25/2024), included a dry weight at 127 kilograms (kg). Pt #3’s treatment sheets from 11/27/2024-12/13/2024 were reviewed and included post-treatment weights that were less than or greater than the dry weight on: - 11/27/2024: 123.5 kg (3.5 kg below) - 11/29/2024: 123.5 kg (3.5 kg below) - 12/11/2024: 128.2 kg (1.2 kg above) - 12/13/2024: 129.5 kg (2.5 kg above) 3. The clinical record for Pt #4 was reviewed on 12/17/2024. Pt #4 was admitted on 9/14/2022, with a diagnosis of ESRD). Pt #4’s hemodialysis treatment order (dated 12/2/2024), included a dry weight at 68.5 kg. Pt #4’s treatment sheets from 11/29/2024-12/13/2024 were reviewed and included post-treatment weights that were less than or greater than the dry weight on: - 11/29/2024: 71.5 kg (3 kg above) - 12/2/2024: 70.2 kg (1.7 kg above) - 12/13/2024: 73.8 kg (5.3 kg above) 4. The clinical record for Pt #6 was reviewed on 12/17/2024. Pt #6 was admitted on 1/31/2023 with a diagnosis of ESRD. Pt #6’s hemodialysis treatment order (dated 12/3/2024, included a dry weight at 79.2 kg. Pt #6’s treatment sheets from 12/3/2024-12/14/2024 were reviewed and included post-treatment weights that were 1 kg less than or greater than the dry weight on: - 12/3/2024: 85.7 (6.5 kg above) - 12/7/2024: 83.6 kg (4.4 kg above) - 12/10/2024: 85.6 kg (6.4 kg above) - 12/12/2024: 83.4 kg (4.2 kg above) - 12/14/2024: 83.4 kg (4.2 kg above) 5. On 12/19/2024 at 12:15 PM, an interview was conducted with a Registered Nurse (E #5). E #5 stated that the doctor usually adjusts the patient’s dry weight. E #5 stated that E #5 would look at the patient’s dry weight over the week (3 treatments) and if the patient is far off from the treatment with about 2 kilograms from the dry weight, then E #5 would notify the physician.”

“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: 34411 Based on document review and interview, it was determined that for 5 of 9 (Pt #2-Pt #6) patients reviewed for assessments, the Facility failed to ensure that pre and/or post assessments were completed on hemodialysis patients, by the registered nurse, as required. Findings include: 1. The Facility’s policy titled, “Pre-Dialysis, Intra-Dialysis and Post-Dialysis Assessment and Care” (dated 12/2024), was reviewed, and required, “Pre-dialysis (assessment and documentation through EMR [electronic medical record], prior to treatment beginning, consists of the following ...General condition of the patient including mental status, skin color, pitting edema ...symptoms or special condition that may require the attention of the physician ...Post-dialysis (assessment includes the following): Patient response to treatment ...The RN [registered nurse] must sign the treatment flow sheet ...” 2. The clinical records for Pt #2-Pt #6, who were admitted with a diagnosis of end stage renal disease (ESRD) were reviewed. The hemodialysis treatment sheets were reviewed for pre and post assessments. The treatment sheet lacked the required pre and post treatment assessments by the RN on the following dates: - Pt #2: 11/30/2024; 12/3/2024; 12/7/2024; 12/10/2024; 12/12/2024; and 12/14/2024 - Pt #3: 11/27/2024; 12/11/2024; and 12/13/2024 - Pt #4: 11/29/2024; 12/2/2024; 12/6/2024; 12/9/2024; and 12/11/2024 - Pt #5: 12/5/2024; 12/10/2024; 12/12/2024; and 12/14/2024 - Pt #6: 12/3/2024; 12/7/2024; 12/10/2024; 12/12/2024; and 12/14/2024 3. On 12/19/2024 at 12:15 PM, an interview was conducted with a Registered Nurse (E #5). E #5 stated that pre and post assessments including listening to lung sounds, checking for edema, and pain, should be done by the RN pre and pot treatments.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 34411 Based on document review and interview, it was determined that for 4 of 4 patients reviewed for mortality, the Facility failed to ensure that a quality indicator was analyzed to identify the cause of patient deaths, as a part of the Quality Improvement Plan, in order to monitor and implement performance action plans. Findings include: 1. The Facility’s Charter titled, “Dialysis Quality Assurance Process Improvement Meeting” (6/2023) was reviewed and required, “...The Dialysis Quality Assurance Program Improvement Committee is a multidisciplinary committee formed to improve and monitor quality outcome initiatives in the outpatient dialysis center...Key measurements of success...deaths...” 2. On 12/18/2024 at approximately 9:30 AM, the Facility’s QAPI (Quality Assurance Program Improvement) activities and meeting minutes were reviewed with the System Director (E #2). Review of mortality data indicated that from 1/2024-12/18/2024, there were 4 patient deaths. The QAPI performance activities related to mortality, included data on the number of deaths. However, there was no data indicating the cause of death or any documentation that analyzed and tracked trends in patient deaths at the Facility. 3. On 12/18/2024 at 10:15 AM, an interview was conducted with the System Director (E #2). E #2 acknowledged that the QAPI meetings lacked analysis of the death.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 34411 Based on document review and interview, the Facility failed to ensure that a quality indicator for anemia was included as a part of the Quality Improvement Plan, in order to monitor and implement performance action plans. This has the potential to affect the 96 patients on census. Findings include: 1. The Facility’s Charter titled, “Dialysis Quality Assurance Process Improvement Meeting” (6/2023) was reviewed and required, “...The Dialysis Quality Assurance Program Improvement [QAPI] Committee is a multidisciplinary committee formed to improve and monitor quality outcome initiatives in the outpatient dialysis center...Key measurements of success...key patient outcome data...departmental key performance indicators...” 2. On 12/18/2024 at approximately 9:30 AM, the Facility’s QAPI performance activities and meeting minutes were reviewed with the System Director (E #2). The QAPI indicators lacked an anemia metric. 3. On 12/18/2024 at 10:15 AM, an interview was conducted with the System Director (E #2). E #2 acknowledged that the QAPI meeting lacked an indicator for review of anemia.”

“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: 34411 Based on document review and interview, it was determined that the Facility failed to ensure that patient safety events were analyzed or investigated as part of the quality improvement activities. This has the potential to affect the 96 patients on census. Findings include: 1. The Facility’s Charter titled, “Dialysis Quality Assurance Process Improvement Meeting” (6/2023) was reviewed and required, “...The Dialysis Quality Assurance Program Improvement [QAPI] Committee is a multidisplinary committee formed to improve and monitor quality outcome initiatives in the outpatient dialysis center...Key measurements of success...key patient outcome data...departmental key performance indicators...” 2. On 12/18/2024 at approximately 9:30 AM, the Facility’s QAPI activities and meeting minutes were reviewed with the System Director (E #2). Review of the QAPI performance activities included 11 patient safety events. The QAPI indicators lacked an metric for patient safety events in order to analyze and investigate the events. 3. On 12/18/2024 at 10:15 AM, an interview was conducted with the System Director (E #2). E #2 acknowledged that the QAPI meeting lacked an indicator for review and analysis of patient safety events.”