Davita Chicago Ridge Dialysis

“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 5 staff (E#4-#7) observed, the Facility failed to ensure that gloves were changed and hand hygiene performed as required. Findings include: 1. The Facility’s policy titled, “Infection Control for Dialysis Facilities” (revised April 2023), was reviewed and required, “All teammates... will perform hand hygiene: ... b. prior to gloving and immediately after removal of gloves. c. after contamination with blood or other infectious material. d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart...” 2. During a tour of the dialysis treatment area on 11/6/2023, the following were observed: - At approximately 9:22 AM, a Patient Care Technician/PCT (E#6) was cleaning a dialysis station after treatment. E#6 then removed gloves and did not perform hand hygiene prior to going to terminate treatment for a patient with a catheter. - At approximately 9:35 AM, a Registered Nurse (E#4) removed gloves after administering medication to a patient and did not perform hand hygiene prior to obtaining clean supplies from the supply drawer. - At approximately 9:38 AM, E#6 went from station #11 to #7 to silence an alarm with the same gloves used at the previous station. - At approximately 9:40 AM, E#7 removed a clamp from a patient’s access site and went to get supplies from the nursing station drawer without removing the gloves and performing hand hygiene. - At approximately 9:45 AM, PCT E#5 touched a patients arm with gloved hands and was preparing to remove the access needles. E#5 then went to grab tape from the clean supply drawer with the same gloves on. - At approximately 10:18 AM, PCT E#7 grabbed the garbage can with gloved hands and brought it to a dialysis station. E#7 used the same gloves to begin care for the patient’s access. 3. An interview was conducted with PCT (E#5) on 11/8/2023, at approximately 11:30 AM. E#5 stated that hand hygiene should always be done after removing gloves. E#6 stated that gloves should be changed (with hand hygiene) when going from station to station or before going to get new clean supplies.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 2 of 3 staff (E#6 and #7) observed performing dialysis station cleaning, the Facility failed to ensure that the dialysis station was vacated before disinfection and that all potentially contaminated areas were cleaned after each treatment. This had the potential to affect all in-center hemodialysis patients on census as of 11/06/2023. Findings include: 1. The Facility’s policy titled, “Infection Control for Dialysis Facilities” (revised April 2023), was reviewed and required, “...At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g. dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g. control panel; top, front, and sides of dialysis machine; touchscreens; countertops)... The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system... Priming containers are to be emptied prior to disinfection... Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient...” 2. During a tour of the dialysis treatment area on 11/6/2023, the following were observed: - At approximately 9:19 AM, a Patient Care Technician/PCT (E#6) was cleaning a dialysis station after treatment. E#6 did not empty and wipe the prime waste receptacle on the machine, did not recline the dialysis chair to clean in between the seat cushions, and did not wipe the wall box. - At approximately 9:47 PM, PCT (E#7) was setting up the dialysis machine at station #2 for the next patient while the previous patient was still sitting in the chair holding their access site. The machine was already priming with solution while the patient was still present. The patient did not vacate the chair until approximately 10:00 AM. E#7 did not empty or wipe the prime waste receptacle and did not wipe the wall box. - At approximately 9:50 AM, E#7 started setting up the supplies in the isolation room (station #1) without completely disinfecting the entire dialysis station. E#7 had only wiped the top and front of the dialysis machine. E#7 did not empty and wipe the prime waste receptacle. 3. An interview was conducted with Patient Care Technician (E#5) on 11/8/2023, at approximately 11:30 AM. E#5 stated that the patient needs to completely leave the station with all their belongings before the staff can start cleaning the dialysis station. E#5 stated that the whole station should be disinfected before setting up for the next patient. E#5 stated that the prime waste container should be emptied in the dirty sink and wiped inside and out. E#5 stated that chairs should be reclined and side panels opened all the way while cleaning to get in between the seat cushions and that the wall box behind the machine should also be disinfected after each treatment.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 10 (Pts. #1, #5, #7, #8, and #9-#14) of approximately 20 patients reviewed, the Facility failed to ensure that Hepatitis B surveillance was completed routinely as required. Findings include: 1. The Facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (dated October 2023), was reviewed and required, “All patients will be routinely tested... Routine Surveillance Testing: [If] Antigen Negative [and] Antibody < (less than) 10 [then] Monthly antigen...” 2. The Facility’s Hepatitis B Report for Peritoneal Dialysis Patients, dated 11/7/2023, was reviewed and indicated the following: - Pt. #5 was susceptible to Hepatitis B since 4/10/2023 and the record lacked monthly antigen labs after 4/10/2023. - Pt. #7 was susceptible to Hepatitis B since 8/17/2023 and the record lacked monthly antigen labs after 8/17/2023. - Pt. #8 was susceptible to Hepatitis B since 6/26/2023 and the record lacked monthly antigen labs for the months of August and September 2023. 3. The Facility’s Hepatitis B Report for In-center Hemodialysis Patients, dated 11/6/2023, was reviewed and indicated the following: - Pt. #1 was susceptible to Hepatitis B since 7/19/2023 and the record lacked monthly antigen labs after 7/26/2023. - Pt. #9 was susceptible to Hepatitis B since 6/28/2023 and the record lacked monthly antigen labs after 8/30/2023. - Pt. #10 was susceptible to Hepatitis B since 6/29/2023 and the record lacked monthly antigen labs after 7/27/2023. - Pt. #11 was susceptible to Hepatitis B since 7/28/2023 and the record lacked monthly antigen labs after 7/28/2023. - Pt. #12 was susceptible to Hepatitis B since 6/27/2022 and the record lacked monthly antigen labs after 7/10/2023. - Pt. #13 was susceptible to Hepatitis B since 6/28/2023 and the record lacked monthly antigen labs after 8/30/2023. - Pt. #14 was susceptible to Hepatitis B since 2/28/2023 and the record lacked monthly antigen labs after 8/31/2023. 3. An interview was conducted with the Peritoneal Dialysis Nurse (E#8) on 11/7/2023, at approximately 12:30 PM. E#8 stated that susceptible patients should have monthly antigens drawn. E#8 stated that if a patient is receiving the vaccine, the time the lab to be drawn right before that administer a dose. E#8 stated that E#8 thought they fixed the problem back in July where the new system would cancel the labs if the vaccine was administered; however, E#8 could did not know why Pts. #5, #7, and #8 had missed monthly labs afterwards. 4. An interview was conducted with the Clinical Coordinator (E#3) on 11/8/2023, at approximately 4:00 PM. E#3 stated that even when patients are receiving the Hepatitis vaccination series, monthly antigen labs should still be drawn. E#3 stated that they try to schedule vaccines to be given at the beginning of the month and labs to be drawn at the end of the month so that they don’t get a false positives. E#3 was not aware that monthly antigens were being missed for susceptible patients. 5. An interview was conducted with the Group Facility Administrator (E#9) on 11/9/2023, at approximately 3:00 PM. E#9 stated that they reviewed the Hepatitis tracker and E#9 was not sure why the system did not draw the labs for several months for certain patients. E#9 stated that these patients are scheduled to have the labs drawn next week and stated that they may need to manually track the hepatitis labs while they work out what’s going wrong with the new medical records system (began May 2023).”

“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: 39802 Based on document review, observation, and interview, it was determined that for 3 of 3 staff (E#5-#7) observed, the Facility failed to ensure that staff performed arteriovenous fistula (AVF) / graft (AVG) access site cannulation (needle insertion) according to infection control guidelines/policy. Findings include: 1. The Facility’s policy titled, “AV Fistula or Graft Cannulation with JMS Sysloc Mini Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (dated October 2022), was reviewed and required, “...Skin Antiseptic: Povidone Iodine [Betadine]; Effective Contact Time: 30 seconds; Air Drying Time: 2 minutes... Do not palpate insertion site once area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation...” 2. During tours of the dialysis treatment area on 11/6/2023, and 11/8/2023, the following were observed: - On 11/6/2023, at approximately 10:51 AM, a Patient Care Technician (E#7) was preparing to initiate dialysis for a patient with an AVF/G access site. E#7 palpated (touched) the access sites after cleansing them. E#7 then inserted the needles without disinfecting the access again. - On 11/6/2023, at approximately 10:55 AM, PCT E#6 was preparing to initiate dialysis for a patient with an AVF/G access site. E#6 cleansed the site with betadine for only 5 seconds (not the required 30 seconds). Approximately 10 seconds later, E#6 inserted the first access needle, without waiting the required 2 minute air drying time. - On 11/8/2023, at approximately 10:15 AM, PCT E#5 had used a stethoscope and gloved hands to assess (touch) a patient’s AVF/G site, after cleaning it with betadine earlier. E#5 did not reclean the access site before cannulation. - On 11/8/2023, at approximately 10:42 AM, E#7 was preparing to initiate dialysis for a patient with an AVF/G access site. E#7 wiped the access site for 5 seconds (not the required 30 seconds) with betadine. Approximately 30 seconds later, E#7 touched the access site with gloved hands and then 30 seconds later inserted the needles. E#7 did not re-clean the site or wait the 2 minutes to allow the betadine to dry. 3. An interview was conducted with E#5 on 11/8/2023, at approximately 11:30 AM. E#5 stated that after doing a preclean with alcohol, the AVF/G access sites should be scrubbed with betadine for 30 seconds and allowed to air dry for 2 minutes. E#5 stated that E#5 usually cleans the access site first and then assesses it; however, E#5 stated that E#5 should have re-cleaned it after touching it.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 3 of 3 staff (E#5-#7) observed, the Facility failed to ensure that appropriate infection control measures were used to perform catheter care. Findings include: 1. The Facility’s procedure titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” (dated October 2023), was reviewed and required, “...Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason... Remove old dressing and discard... Remove gloves and discard. Perform hand hygiene per procedure and re-glove... [Clean exit site and CVC limbs]... Remove gloves and discard, perform hand hygiene per procedure and re-glove... [Apply dressing]... Remove gloves and discard, perform hand hygiene and re-glove...” 2. During tours of the dialysis treatment area on 11/6/2023 and 11/8/2023, the following was observed: - On 11/6/2023, at approximately 9:30 AM, a Patient Care Technician/PCT (E#7) was preparing to terminate a dialysis treatment for a patient with a central venous catheter (CVC). E#7 disconnected both bloodlines and did not disinfect the hubs prior to connecting a syringe to the hub. After removing the syringes, E#7 only wiped each hub for approximately 2 seconds (not the required 15 seconds) before placing caps on the ends. - On 11/6/2023, at approximately 10:30 AM, PCT E#6 removed the old dressing from a patient’s CVC and did not change gloves and perform hand hygiene prior to clean the exit site. E#6 scrubbed the exit site for 10 seconds with chloraprep (not the required 30 seconds). After completing exit site care, E#6 wiped the arterial and venous catheter hubs for only 3 seconds (not the required 15 seconds) each before connecting the bloodlines. - On 11/6/2023, at approximately 11:03 AM, PCT E#5 removed the exit site dressing and catheter hub dressing off a patient with a CVC. E#5 used the same gloves to setup up new supplies to initiate treatment for the patient. - On 11/8/2023, at approximately 11:15 AM, E#7 was performing exit site care for a patient with a CVC. E#7 cleaned the exit site with chloraprep for 15 seconds (not the required 30 seconds) and immediately placed the gauze dressing on without waiting the required 1 minute. 3. An interview was conducted with PCT (E#5) on 11/8/2023, at approximately 9:30 AM. E#5 stated that CVC sites should be cleaned with chloraprep for 30 seconds and allowed to dry for 1 minute prior to placing the dressing on. E#5 stated that hubs should be scrubbed with alcohol for at least 15 seconds when connecting or disconnecting bloodlines. 4. An interview was conducted with PCT (E#7) on 11/8/2023, at approximately 1:15 PM. E#7 stated that gloves should be changed and hand hygiene performed when removing the old catheter dressings during CVC exit site care.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 3 of 3 staff observed (E#5-#7), the Facility failed to ensure that pH (measure of acidity/alkalinity) testing was conducted with an appropriate/approved method; that the manufacturer’s instructions for use (IFU) and/or policy were followed; and that staff were aware of the acceptable range for pH. This had the potential to affect all in-center dialysis patients as of 11/06/2023. Findings include: 1. The Facility’s policy titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” (dated April 2020), was reviewed and required, “...Trained teammates will test pH... of final dialysate utilizing appropriate test strips... prior to each patient treatment... The acceptable range for final dialysate pH is 6.9-7.6. Check independent pH with approved test method for final dialysate...” 2. The Facility’s procedure titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8-8.5 Test Strips” (dated October 2020), was reviewed and required, “2. Obtain dialysate sample by using a disposable cup, then dip the strip in the solution for one (1) second. Or using new syringe, obtain dialysate sample from sample port, then allow fluid to flow over the pad for one (1) second. 3. Remove the strip from the fluid and shake off excess dialysate. 4. At 10 seconds, immediately compare the color reaction on strip to the color chart on bottle to determine the closest match...” 3. During a tour of the dialysis treatment area on 11/06/2023, the following was observed: - At approximately 9:07 AM, a Patient Care Technician/PCT (E#5) went to a dialysis station with a bottle of RPC E-Z Check K100-104.5 pH Test Strips (incorrect test strips, per manufacturer these strips should only be used to test water used for preparing dialysate, not for testing the dialysate itself). E#5 obtained a sample of final dialysate from a dialysis machine and applied it to the test strip. The color pad appeared to be darker than the 7.5 color block (the next increment on the color chart was 8.0). E#5 was unsure of the exact range for pH and stated that the pH should be somewhere around 7.0-7.5. E#5 stated that the result looked closer to 7.5 and that it’s okay if the color is between 7.5 and 8.0. - At approximately 10:50 AM, PCT (E#6) obtained a sample of final dialysate. E#6 dipped the correct pH test strips (K100-0117CT) into the sample for approximately 5 seconds and read the test strip right away (without waiting the required 10 seconds). - At approximately 11:16 AM, PCT (E#7) obtained a sample of final dialysate and applied it to the correct pH test strips (K100-0117CT); however, E#7 did not bring the bottle to the station when testing to compare the strip to the color chart and left it on the strip on the machine. E#7 did not return with the pH strip bottle to check the result within the allotted 10 seconds. 4. An interview was conducted with E#7 on 11/06/2023, at approximately 11:17 AM. E#7 stated, “We’re supposed to compare it with the bottle, I’ve been doing this a long time and it should be a nice olive green color. I look at it right away (no wait). As long as the color is on the bottle (6.8-7.8), it’s okay.” 5. An interview was conducted with E#6 on 11/6/2023, at approximately 11:34 AM. E#6 stated that the E#6 dips the strip in the solution for 15 seconds and reads it right away. E#6 stated that an acceptable pH is 6.9-7.5.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 2 of 2 patient records (Pt. #1 and #3) reviewed for allergies, the Facility failed to ensure that the patients’ allergies were evaluated/assessed and kept current in the medical record. Findings include: 1. The Facility’s policy titled, “Accepting End Stage Kidney Disease Patients for Treatment” (dated October 2023), was reviewed and required., “...After Acceptance of a new patient... and prior to Admission... the treating facility must obtain and document... the following up-to-date information for each patient... b. Copy of History and Physical (within the last year - must be legible)... Confirm that the following medical records are received and recorded... Allergies...” 2. The Facility’s policy titled, “Initial Patient Nursing Assessment for New Patients” (dated October 2021), was reviewed and required, “... A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility. The minimal nursing evaluation prior to initiating treatment for a patient new to the facility should include: ...General assessment... the registered nurse will review the patient’s current home medications and determine any potential treatment implications... This initial pre-treatment evaluation will be retained in the patient’s medical record...” 3. The clinical record of Pt. #1 was reviewed on 11/8/2023. Pt. #2 was admitted on 3/1/2023 with a diagnosis of end-stage renal disease (ESRD). The patient’s record included a pre-admission Hospital record, dated 2/21/2023, that indicated Pt. #2 became encephalopathic after receiving cefepime (an antibiotic). The Facility’s Medication Report, dated 4/28/2023, indicated there was “no data” to report under allergies. The treatment record, dated 8/9/2023, indicated that pre-treatment Pt. #1 was alert. During treatment, Pt. #1 reported chills and shivering, and 2 grams of cefepime was ordered and administered. The post-treatment assessment noted that there was a change in Pt. #1’s mental status as Pt. #1 had a decreased level of alertness. Thereafter, a nurse’s note included, “When pt’s caregiver arrived to pick pt up, she was updated. She [caregiver] reports pt was allergic to Cefepime. We had ‘no known allergies’ listed in the chart ... She reports it causes encephalopathy ...” Pt. #1 was subsequently sent to the hospital and remained there until 8/14/2023. The record lacked documentation that an initial nursing assessment was completed for Pt. #1. 3. The clinical record of Pt. #3 was reviewed on 11/8/2023. Pt. #3 was admitted on 5/16/2019, with a diagnosis of ESRD. A hospitalization record, dated 9/7/2023, included allergies to aspirin (pain medication), iodine (chemical element found in medication and antiseptics), and latex (natural rubber). However, the Patient’s Summary Report as of 11/7/2023 listed “No known allergies.” 4. An interview was conducted with the Facility Administrator (E#1) on 11/9/2023, at approximately 1:30 PM. E#1 stated that the nurse conducts an initial nursing assessment upon admission and is responsible for reconciling medications and reviewing the patient’s medical history including allergies, and entering into the medical record system. E#1 stated that the nurse will reconcile home medications monthly and should review records received from hospitalizations to ensure that any changes are updated in the record and should include adding any new allergies reported.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 2 of 3 staff (E#6 and #7) observed, the Facility failed to ensure that staff assessed for the presence of a bruit (sound of blood flowing through access) and/or thrill (vibration indicating blood flow) prior to cannulating (inserting dialysis access needle) a fistula (AVF) or graft (AVG) access site. Findings include: 1. The Facility’s procedure titled, “AV Fistula or Graft Cannulation with JMS Sysloc Mini Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (dated October 2022), was reviewed and required, “...Perform inspection, auscultation [listen with stethoscope] and palpation [feel with fingers] on entire length of access. Determine presence of bruit and thrill. The presence of a bruit and thrill indicates flow through the access. If bruit or thrill is not present... do not cannulate. Notify licensed nurse of access status for follow-up. Absence of a bruit or thrill could indicate a clotted access...” 2. During a tour of the dialysis treatment area on 11/6/2023, the following were observed: - At approximately 10:51 AM, a Patient Care Technician (E#7) was preparing to initiate dialysis for a patient with an AVF/G access site. E#7 palpated (touched) the access sites but did not use a stethoscope to listen for a bruit prior to cannulating the access site. - At approximately 10:55 AM, PCT E#6 was preparing to initiate dialysis for a patient with an AVF/G access site. E#6 did not perform an assessment of the access site (by listening with a stethoscope or palpating with fingers) prior to cannulating the access site. 3. An interview was conducted with PCT E#5 on 11/8/2023, at approximately 11:30 AM. E#5 stated that for patients with AVFs or AVGs, the access site must be assessed prior to cannulating. E#5 stated that the access check includes using a stethoscope to listen for a bruit and feeling the site for a thrill. E#5 stated that if one or both are missing (bruit or thrill), it may indicate the access is clotted.”

“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: 39802 Based on document review and interview, it was determined that for 2 of 3 patient (Pts. #1 and #2) records reviewed with incidents, the Facility failed to ensure that medical errors/injuries were reported, investigated, and/or tracked as part of the Facility’s quality improvement program. Findings include: 1. The Facility’s policy titled, “Risk Event Reporting Policy” (dated July 2023), was reviewed and required, “...Any unexpected event that is inconsistent with the routine operation of a dialysis facility, routine provision of acute dialysis or ancillary renal-related services may be a risk event... All risk events will be promptly reported to the Facility Administrator/Manager or designee... The teammate involved in the risk event or who witnessed the risk event firsthand will complete a Risk Event Management (REM) Report. The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened... REM Reports are to be trended and reviewed during the Facility Health Meeting (FHM)... Examples of Reportable Risk Events: ...Allergic Reaction or Adverse Drug Reaction... Medication Error... Prolonged Bleeding Post Treatment (>30 mins)...” 2. The clinical record of Pt. #1 was reviewed on 11/8/2023. Pt. #1 was admitted on 3/1/2023 with a diagnosis of end-stage renal disease (ESRD). Pt. #1’s hard chart included a Hospital Record, dated 2/21/2023 (pre-admission), which included “Patient became encephalopathic [disease of brain structure causing altered mental ] after receiving cefepime [antibiotic].” The Facility’s Home Medication Reconciliation Record, dated 4/28/23, indicated that no allergies were entered for Pt. #1. Treatment records on 8/9/2023 indicated that Pt. #1 complained of chilling and shivering and cefepime was ordered and administered during treatment. A nurse’s note included, “When pt’s caregiver arrived to pick pt up, she [caregiver] was updated. She reported pt was allergic to Cefepime. We had ‘no known allergies’ listed in the chart...” Pt. #1 was subsequently sent to the hospital following dialysis treatment with altered mental status. 3. The clinical record of Pt. #2 was reviewed on 11/8/2023. Pt. #2 was admitted on 2/5/2020 with a diagnosis of ESRD. The record indicated that Pt. #2 had an episode of prolonged bleeding (greater than 40 minutes) after treatment on 9/13/2023. On 10/13/2023, a nurse’s note indicated that Pt. #2 was administered a heparin bolus instead of an infusion as ordered. 4. The Facility’s REM System was reviewed with the Facility Administrator (E#1) and Manager of Clinical Services (E#2) on 11/8/2023. The system included an event filed for Pt. #1’s allergic reaction on 8/9/2023. The event was filed under “Unexpected Hospitalization.” There was no evidence or documentation to indicate that Pt. #1’s incident was investigated to determine why it happened and no action plan was implemented to prevent recurrence. There were no reports filed for Pt. #2’s two events on 9/13/2023 and 10/13/2023. 5. The Facility’s REM Tracking Binder was reviewed for 2023 and indicated there were no allergic reactions or unexpected hospitalizations in August 2023, no prolonged bleeding in September 2023, and no medication administration errors in October 2023; therefore, the REM Tracker lacked inclusion of Pt. #1 and #2’s risk events. 6. An interview was conducted with E#1 and E#2 on 11/8/2023, at approximately 2:30 PM. E#2 stated that medication administration errors and prolonged bleeding greater than 30 minutes should be reported in the REM system. E#2 stated that risk events are manually tracked in the REM Binder. E#1 reviewed the binder and could not find documentation that Pt. #1’s or #2’s events were included in the tracking. During another interview with E#1 on 11/9/2023, at approximately 12:15 PM, E#1 stated that Pt. #1 was sent to the hospital and returned the following week. E#1 stated that the event was not escalated or investigated further.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 10 of 12 grievances reviewed, the Facility failed to ensure that grievances were reviewed/investigated and steps were taken to resolve the grievance. This had the potential to affect all patients on census. Findings include: 1. The Facility’s policy titled, “Patient Grievance” (dated October 2021), was reviewed and required, “...Internal Grievance Process: ... The FA [Facility Administrator] (or her/his designee) is to discuss the grievance with the patient, investigate and take appropriate action towards a solution...” 2. The Facility’s Patient Grievance Log from June 2023-October 2023 was reviewed and indicated that there were 12 complaints filed. The Grievance Binder did not contain completed Grievance/Investigation Documents (Form #3-01-06D) for 10 of the complaints to show that the grievances were investigated and what steps were taken to resolve the grievances. 3. An interview was conducted with the Facility Administrator (E#1) on 11/8/2023, at approximately 9:45 AM. E#1 stated that when a teammate receives a grievance/complaint from a patient, they will escalate it to E#1 right away. E#1 stated that depending on whether the patient is available, they will try to investigate and resolve the grievance within 7 days. E#1 could not find the any documentation to show that the 10 grievances were addressed. E#1 stated that the #3-01-06D form should be completed for each grievance received.”