Coryell Dialysis

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 30377 Based on review of governing body minutes, medical record review, and staff interviews the facility failed to assess each patient’s individual dialysis needs and evaluate if the dialysis prescription was meeting those needs. The findings include. Review of governing body minutes on 02/27/2025 revealed the following: On 02/12/2025 the facility had experienced water issues resulting in the inability to complete in-center hemodialysis treatments. The bicarb mixing machine did not turn on, and the facility was not able to initiate dialysis treatment for the 34 patients scheduled that day. The next scheduled treatment day, 02/14/2025, the facility failed to provide its patients with full-length treatment due to limited supply of bicarb; all patients treatments were shortened. This was done as a blanket order for all 34 patients without consideration of appropriateness of dialysis prescription and health status. Patient #2 Review of in-center dialysis flow sheets from 02/03/2025 to 02/14/2025 revealed the following: Patient has a history of no-shows and shortened treatments. 02/12/2025 Facility Closed due to water issues. 02/14/2025 EDW: 95.5 Pre weight: 104.1 Last Weight: 96.8 Gain: 7.3 Lost: 1.2 Post: 102.9 Fluid Removed: 1.65 Liters Starting Vitals Sitting: 234/102 Ending Vitals Sitting: 237/110 The registered nurse documented the following under Initial Nursing Note and Post Nursing Note: Initial Nursing Note: “Goal set for 2.4 kilos ...Elevated BP at treatment start. Cuff on patient’s wrist.” Post Nursing Note: “Completed 0.8 out of a 2-hour treatment: Patient complained of pain all over and moaned during treatment because of itching and sores all over her body. States she is going to have a biopsy done to determine what is going on. Advised to monitor her fluid intake over the weekend and go to ER if she has S/S of fluid overload or mentation changes. Patient signed AMA.” Review of nurse progress note dated 02/14/2025 revealed the following documentation: At 5:18 P.M. Contacted [attending physician], discussed patient arrived to clinic pre [blood pressure] 234/102, [heart rate] 73, treatment started. Patient given Clonidine 0.1 mg per protocol for elevated [systolic blood pressure] >180. Patient completed 48 minutes of treatment and signed out [Against Medical Advise], complaining of pain. Patient stated to [Certified Clinical Hemodialysis Technician] she was in so much pain she was going to go to the [emergency room] tomorrow. [Attending physician] stated patient signed out [Against Medical Advise], no further orders. There was no documentation found that the registered nurse notified the attending physician that the patient arrived at the facility 8.6 kilograms above her estimated dry weight. There was no documentation found that the registered nurse notified the attending physician that a blanketed two-hour treatment would not adequately meet the needs of this patient in severe volume overload. There was no documentation found that the registered nurse notified the attending physician that the patient was discharged from the dialysis unit with severe hypertension 237/110 and that the Clonidine administered was not effective. There was no documentation found that the registered nurse notified the attending physician that the patient was discharged from the dialysis unit 7.4 kilos above estimated dry weight with no plans to dialysis the patient the following day? Review of hospital records for patient #2 dated 2/14/2025 revealed the following: A 62-year-old female with history of Endstage Renal Disease on hemodialysis, Congested Heart Failure, Coronary Artery Disease, S/p cardiac arrest 2024, and Diabetes Mellitus presents to the emergency room with husband for shortness of breath, chest tightness and painful rash all over the body. Patient admitted for acute heart failure exacerbation after missing hemodialysis ...She was found to be Covid positive. She was found to have a small bowel obstruction and a transverse colon obstruction within a large ventral hernia which is chronically incarcerated and partially reducible. She continues to have bowel function. Given her symptoms and large mouth of the hernia, it is unlikely that the bowel is threatened and in need of emergent operation. Work up on admission with CXR significant for Congested Heart Failure and Volume overload. Confirmed through interviews with the facility administrator on 02/25/2025 at 10:30 A.M., she confirmed that the facility had experienced water issues on 02/12/2025, leaving it unable to complete dialysis treatment for all 34 patients scheduled. The facility administrator confirmed the following treatment day that all patients were offered two hours of treatment without consideration of appropriateness of dialysis and or health status due to limited bicarb supplies. The facility administrator confirmed that patient #1 remained in the hospital at time of interview. Confirmed with staff # 2 on 03/11/2025 after her own review, the following events from 02/12/2025: There was no documentation found that the registered nurse notified the attending physician that the patient arrived at the facility 8.6 kilograms above her estimated dry weight. There was no documentation found that the registered nurse notified the attending physician that a blanketed two-hour treatment would adequately meet the needs of this patient in severe volume overload. There was no documentation found that the registered nurse notified the attending physician that the patient was discharged from the dialysis unit with severe hypertension 237/110 and that the Clonidine administered was not effective. There was no documentation found that the registered nurse notified the attending physician that the patient was discharged from the dialysis unit 7.4 kilos above estimated dry weight with no plans to dialysis the patient the following day?”

“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: 50181 Based on clinical record review, facility policies and interviews with staff #8 the facility failed to ensure a specific order was received for instilling heparin as an intervention for poor flow of a Peritoneal Dialysis (PD) catheter. Findings: Clinical record review of patient #1 revealed the following: “02/03/2025 10:30 Nurse: Labs and PD Catheter Troubleshooting ...The patient exit site is clear, no S/S infection or occlusion. To initially assess catheter patency, I used a 60mL syringe with 45mL of heparin to connect directly to the transfer set, using aseptic technique per protocol. I applied gentle pressure to the syringe plunger. I used gentle pressure to push and pull the heparin until it started going through the catheter. After 3-4 minutes the catheter flow was greatly improved, but I did not feel the problem was fixed. I had pulled back all of the 45mL of the heparin into the syringe but did not see the fibrin in the syringe or the catheter tubing. The patient and her spouse agreed they did not see the fibrin during this process. [Attending Physician] called and I left the room, leaving the syringe with heparin connected to the patient transfer set, to speak with him. I updated [Staff # 2] (facility administrator) and she was going to assess the catheter as well. [Attending Physician]advised that if we were unable to restore patency we would use Activase. While I checked another patient, [Staff # 2], went into the room with [patient #1]. I went back into the room with [patient #1] about 20 minutes later. [Staff # 2], FA, had a different syringe connected to [patient #1]’ transfer set, and [staff #2], FA, let me know the catheter was now working very well. I thanked her and then spoke with the patient and her spouse about the next steps. I wanted to check the catheter patency before connecting to an ultrabag, so I connected another 60mL syringe to the transfer set and used the push/pull method to assess patency. The flow in and out was much easier than before. I noted the fluid to be pink-tinged. I pulled back on the syringe and got about 30mL of fluid and took a picture of the syringe for [attending physician]. I still not see any fibrin. I then connected the patient to a 1.5%, 2000mL ultrabag. The patient and her husband acknowledged I was going to use the dialysate to do a flush, not a dwell. There was zero on the initial drain and the fill was a little on the slow side. I filled with 300 then immediately drained. To facilitate the drain I had the patient sit forward, sit back, change position. The total fill time for 900mL was 15 minutes. The total drain time for 700mL was 20 minutes. The patient reported no pain or discomfort. Sue, FA, and [attending physician] updated.” During an interview with Staff #8 she stated, there was no specific order for the 45mL of Heparin but it’s what she was taught and what they have done in the past. In review of the “Chronic Peritoneal Dialysis Orders,” there is no standing order for indwelling 45mL of heparin for PD catheter issues. In review of patient #1 medication list there is no order for 45mL of heparin for PD catheter issues. The above findings were confirmed with staff #2 and staff #8.”

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 30377 Based on a review of facility documentation and staff interviews, the facility failed to develop and maintain an emergency preparedness plan that evaluated hazards and or risks to the facility and develop and implement plans to address those risks. Findings were: In an interview with the facility administrator, on 1/29/25 at 2:30 p.m., while discussing the events of 1/27/25 and 1/28/25 when the facility was unable to complete in-center hemodialysis treatments due to water issues, the facility administrator confirmed that the facility did not have an emergency preparedness plan. The facility administrator asked “Where would I get an emergency plan?””

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 30377 Based on observation, review of the dialysis machine disinfection logs, and policy and procedures, the facility failed to ensure that all equipment were maintained and operated in accordance with the facilities policy and procedures and or manufacturer’s recommendations. Interview conducted with biomed and the facility manager on 1/30/25 at 10:25 a.m. following their own review of the findings revealed that they were unaware of the discrepancies found. When asked who was responsible for review of facility logs and who completed monthly audits the biomed responded he did not know. He stated he comes to the facility with a check list of items to complete. The facility manager stated she does not review facility logs. The biomed also stated he did not know how to complete a facility audit. On 1/30/25 approximately 10:35 AM spoke with Biomed Operation Manager that stated the biomed was responsible for facility log audits. The findings included: Cross reference tags V403”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 30377 Based on a review of facility documentation and staff interviews, the facility failed to develop and maintain an emergency preparedness plan that evaluated hazards and or risks to the facility and develop and implement plans to address those risks. Based on observation, review of the dialysis machine disinfection logs, and policy and procedures, the facility failed to ensure that all equipment were maintained and operated in accordance with the facilities policy and procedures and or manufacturer’s recommendations. Based on review of hemodialysis flow sheets and staff interview the facility failed to ensure that direct patient care staff reported significant changes in patient health status while receiving hemodialysis to the charge nurse and or the charge nurse failed to reassess the patient when significant changes occurred during treatment. Based on employee file review and staff interview the facility failed to follow state and federal requirements in the standards of practice by direct patient care staff. Based on review of Quality Assessment and Improvement Performance (QAPI) meeting minutes and staff interview the Medical Director failed to ensure that monthly QAPI meetings were held and that required staff attend and participate in the QAPI meetings. The medical director failed to ensure that the facility identify opportunities for improvement, develop and implement performance improvement plans, and evaluate the data collected for revision of improvement plans as necessary until resolved. These deficient practices identified have the potential to cause harm to all patients at the facility. . The findings included: Cross reference tags V403 V 504, V 628, V637. V638 V692”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 30377 Based on a review of facility documentation and staff interviews, the facility failed to develop and maintain an emergency preparedness plan that evaluated hazards and or risks to the facility and develop and implement plans to address those risks. Based on observation, review of the dialysis machine disinfection logs, and policy and procedures, the facility failed to ensure that all equipment were maintained and operated in accordance with the facilities policy and procedures and or manufacturer’s recommendations. Based on review of hemodialysis flow sheets and staff interview the facility failed to ensure that direct patient care staff reported significant changes in patient health status while receiving hemodialysis to the charge nurse and or the charge nurse failed to reassess the patient when significant changes occurred during treatment. Based on employee file review and staff interview the facility failed to follow state and federal requirements in the standards of practice by direct patient care staff. Based on review of Quality Assessment and Improvement Performance (QAPI) meeting minutes and staff interview the Medical Director failed to ensure that monthly QAPI meetings were held and that required staff attend and participate in the QAPI meetings. The medical director failed to ensure that the facility identify opportunities for improvement, develop and implement performance improvement plans, and evaluate the data collected for revision of improvement plans as necessary until resolved. These deficient practices identified have the potential to cause harm to all patients at the facility. . The findings included: Cross reference tags V403 V 504, V 628, V637. V638 V692”

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 50181 Based on record review and interview, the facility staff failed to provide documented evidence that fire drills and quarterly emergency preparedness was completed with the 32 in-center hemodialysis patients that receive dialysis treatments at the facility. This deficient practice has the likelihood to cause harm to the health and safety of all patients and staff within the facility during the event of an emergency. Findings: A report titled, “Emergency Take Off Procedure Review,” with the date range of 01/01/2024-02/05/2025 for review. 20 patients have a documented review of the emergency take off procedure for quarter 1 in 2024 during the month of April. 3 patients have a documented review of the emergency take off procedure for quarter 2 in 2024 during the month of May. There is no evidence of quarter 4 review with patients in 2024. There have been no emergency reviews conducted at this time for quarter 1 of 2025. There is no evidence that the staff participate in the fire drills or receive the required education to ensure they understand their role in the event of a fire or other emergency requiring evacuation. In an interview with the Facility Administrator on 02/05/2025, she confirmed the above and verbalized understanding of the importance of ensuring all patients receive quarterly education related to the emergency disconnect and evacuation procedures and that all staff have the required training, at least annually.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 50181 Based on observation and interview the facility failed to safeguard medication in enclosures that are not accessible to unauthorized persons. These findings have the potential to allow medications to be tampered with or removed from the facility by unauthorized persons. Failure to safeguard medications within the facility with the potential of the medications being tampered with or removed from the facility by unauthorized persons could negatively impact the health and well-being of the 34 in-center hemodialysis patients and the 5 peritoneal dialysis patients receiving dialysis treatments at the facility. During an observation, of the dialysis treatment area, on 02/04/2025, with the Facility Administrator, multiple medications were observed left out from the previous day unsecured and accessible to unauthorized persons entering and exiting the facility.The FA confirmed the above findings during the tour and confirmed the medications should have been secured prior to the staff leaving the facility on 02/03/2025.”

“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: 50181 Based on observation and staff interview during a facility tour on 02/04/2025 the facility failed to ensure expired supplies were discarded on or before the expiration date and not available for patient use in the facility. The use of expired supplies within the facility has the potential to negatively impact the 34 in-center hemodialysis patients and 5 peritoneal dialysis patients receiving dialysis treatments within the facility. Findings included: During a tour of the facility hemodialysis treatment floor and the peritoneal (PD) dialysis treatment rooms on the morning of 02/04/2025, the following expired supplies were found and available for patient use: 1 package of AED defibrillator pads with a stamped expiration date of 2024-09-282 un-opened Yankauer Suction instruments with a stamped expiration date of 2024-10-303 un-opened Nasal Cannulas with Non-Flared Tips with a stamped expiration date of 2024-05-25 4 un-opened Nasal Cannulas with Non-Flared Tips with a stamped expiration date of 2024-11-06 1 opened gallon jug of Naturalyte with a stamped expiration date of 2024-01-31 In an interview with the Facility Administrator, on 02/04/2025, she confirmed the supplies were expired and still available for patient use within the facility.”

“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: 50181 Based on observation and staff interview during a facility tour on 02/04/2025 the facility failed to ensure expired medications were discarded on or before the expiration date and not available for patient use in the facility. The use of expired medications could negatively impact the health and well-being of the 34 in-center hemodialysis patients and 5 peritoneal dialysis patients receiving dialysis treatments at the facility. Findings included: During a tour of the facility treatment floor on the morning of 02/04/2025, the following expired medications were found and available for patient use: 1 bottle of multi-use oral Liquacel in the medication area with a stamped expiration date of 12/20241 bottle of multi-use oral Liquacel in the medication area with a stamped expiration date of 01/2025 1 single use package of oral Liquacel in the medication area with a stamped expiration date of 01/20251 opened vial of muli-use tubersol without an opened date resulting in the inability to determine the date of discard which is noted as 30 days after opening on the tubersol packaging In an interview with the Facility Administrator on 02/04/2025 she confirmed the medications were expired and still available for patient use.”

“EQUIPMENT-GENERAL/BACK UP PLAN CFR(s): 494.40(a) 5 Equipment 5.1 General: back up plan A dialysis facility should develop contingency plans to cover the failure of its water purification and distribution system or a critical component of that system. Such contingency plans should describe how to deal with events that completely prevent dialysis from being performed, such as failure of the facility’s municipal water supply or electrical service following a natural disaster or water main break. Other plans should address how to deal with sudden changes in municipal water quality, as well as with failure of a critical component of the water purification and distribution system. This Standard is not met as evidenced by: 30377 Based on record review and interview, facility failed to develop and implement policies and procedures to address a contingency plan for failure of its water and water treatment system. Findings were: On 01/29/25 at 2:30 p.m. the surveyor requested from the facility administrator evidence of a plan to address failure of the facility’s water and water treatment system. The facility administrator stated that the facility did not have a written plan in place.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30377 Based on observation, review of the dialysis machine disinfection logs, and policy and procedures, the facility failed to ensure that all equipment were maintained and operated in accordance with the facilities policy and procedures and or manufacturer’s recommendations. The findings were: Tour of the dialysis treatment area on 1/29/25 at 3:15 p.m. revealed that all 12 hemodialysis machines on the treatment floor that were ready for use revealed the last DIASAFE Filter change occurred 10/29/24 which exceeded the manufacture’s recommendation of replacement every 90 days. Review of dialysis machine disinfection logs for December 2024 and January 2025 on 1/30/25 at 09:40 a.m. in the facility’s conference room revealed that high level disinfection (bleaching) of the hemodialysis machine was not documented as completed weekly. The following was observed: December 2024 high level disinfection (bleaching) of the dialysis machine documented completed on 12/2/24, 12/16/24 and 12/30/24. 12/2/24 only dialysis machine labeled #2 revealed documentation that high level disinfection occurred. 12/16/24 all dialysis machines revealed documentation that high level disinfection occurred. 12/30/24 only dialysis machines labeled #1, #3, #4, #10, and #11 revealed documentation that high level disinfection occurred. January 2025 high level disinfection (bleaching) of the dialysis machine documented completed on 1/6/25, 1/13/25 and 1/20/25. 1/06/25 only dialysis machine labeled #2 and #12 revealed documentation that high level disinfection occurred. 1/13/25 only dialysis machine labeled #8 and #11 revealed documentation that high level disinfection occurred. 1/20/25 all dialysis machines revealed documentation that high level disinfection occurred. Facility Policy titled Hemodialysis: Policy 730 Cleaning and Disinfection of the Internal Fluid Pathway of the Delivery System stated the facility will establish a regular schedule for performing daily and weekly acid rinsing, cleaning, and disinfection procedures on delivery systems that meet or exceed Coryell Dialysis policy and manufacturer recommendations. Interview conducted with biomed and the facility manager on 1/30/25 at 10:25 a.m. following their own review of the findings revealed that they were unaware of the discrepancies found. When asked who was responsible for review of facility logs and who completed monthly audits the biomed responded he did not know. He stated he comes to the facility with a check list of items to complete. The facility manager stated she does not review facility logs. The biomed also stated he did not know how to complete a facility audit. On 1/30/25 approximately 10:35 AM spoke with Biomed Operation Manager that stated the biomed was responsible for facility log audits.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 50181 Based on record review and interview, it was determined that the facility failed to provide evidence of patient participation in the facility’s care plan process for all patients receiving dialysis treatments at the facility. Patients have the right to know about and participate in their care and treatment to the extent they desire. Findings include: A review of the plan of care for 4 patients revealed that patients had not been invited to the IDT (Interdisciplinary Team) meeting. None of the patients had documentation showing that the patients were invited to attend their Plan of Care meeting. An interview with Staff #11 (LMSW) on 02/05/2025 confirmed the lack of evidence of the patient being invited to attend an IDT (Interdisciplinary Team) meeting to discuss the patient’s Plan of Care.”

“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: 30377 Based on review of hemodialysis flow sheets and staff interview the facility failed to ensure that direct patient care staff reported significant changes in patient health status while receiving hemodialysis to the charge nurse and or the charge nurse failed to reassess the patient when significant changes occurred during treatment. The findings included: Review of hemodialysis flow sheets dated 1/24/25 in the facility conference room revealed an example of the following discrepancies: Patient # 4 Flow Sheet Dated: 1/24/25. Initiation of treatment: 10:01 AM Termination of treatment: 13:35 PM. Pre-Vitals: 206/119 heart rate 85. During treatment blood pressure recorded from 167/86 to 206/113 with heart rate recorded from 60-79. Post Vitals: 205/106 heart rate 73. The Following vitals were recorded: 10:01 AM: Blood Pressure: 187/97 with heart rate 78. There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. 10:32 AM: Blood Pressure: 190/99 with heart rate 69: There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. 13:32 PM: Blood Pressure: 204/95 with heart rate 69. There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. 13:35 AM: Blood Pressure: 206/113 with heart rate 78. There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. Treatment termed at 13:35 PM. Post Vitals: 205/106 heart rate 73. 14:22 PM The registered nurse documented “Goal met. Patient tolerated treatment well ...” There was no documentation found that the registered nurse addressed the elevated blood pressure during treatment and at time of discharge. There was no documentation found that PRN Clonidine was offered or refused by the patient. There was no documentation that the attending physician was notified of the hypertension prior to discharge. Patient # 5: Flow Sheet Dated: 1/24/25. Initiation of treatment: 13:56 PM Termination of treatment: 17:28 PM. Pre-Vitals: 226/103 heart rate 73. During treatment blood pressure recorded from 169/83 to 199/95 with heart rate recorded from 68-85. Post Vitals: 180/74 heart rate 84. The Following vitals were recorded: 13:58 PM: Blood Pressure: 199/95 with heart rate 68. There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. 14:02 PM: Blood Pressure: 194/87 with heart rate 66: There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. 15:03 PM: Blood Pressure: 187/94 with heart rate 73. There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. 17:28 AM: Blood Pressure: 190/76 with heart rate 77. There was no documentation found that the direct patient care staff notified the registered nurse of the elevated blood pressure. There was no documentation found that the registered nurse addressed the hypertension. Treatment termed at 17:28 PM. Post Vitals: 180/74 heart rate 84. 17:51 PM The registered nurse documented “Goal not met d/t cramping and patient requested to end treatment ...” There was no documentation found that the registered nurse addressed the elevated blood pressure during treatment and at time of discharge. There was no documentation found that PRN Clonidine was offered or refused by the patient. There was no documentation that the attending physician was notified prior to discharge. A review of the facility policy, “Abnormal Findings to Report to the RN” stated: PCT/CCHT/LPN: Reports to Charge Nurse Pre-Dialysis: B/P Systolic >180 B/P Diastolic <=100 Pulse < 60 > 100 PCT/CCHT/LPN: Reports to Charge Nurse Intra-Dialysis: B/P Systolic: 20mmHg change from typical. PCT/CCHT/LPN: Reports to Charge Nurse Post-Dialysis: B/P Systolic: 40mmHg difference from typical or SBP > 140, < 90 An interview conducted with the facility administrator on 2/04/25 following her own review of the findings revealed she was unaware of the discrepancies found in the flow sheets. The facility administrator confirmed the above findings. When the facility administrator was asked how often flow sheets were reviewed the facility administrator stated she does not review flow sheets.”

“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: 30377 Based on review of Quality Assessment and Improvement Performance (QAPI) meeting minutes and staff interview the facility failed to analyze, make recommendation, and develop action plans including root cause analysis to minimize events that occurred in the facility and take appropriate action to reduce future events. These deficient practices identified have the potential to cause harm to all patients at the facility. Findings were: Review of Quality Assessment and Improvement Performance meeting minutes from September 2024 to January 2025 on 2/4/25 in the facility’s conference room revealed the following: The facility did not complete a QAPI meeting in the month of October 2024 and January 2025. Review of QAPI attendance sheets for the months reviewed did not reflect that all mandatory members participated in the meetings. The following was observed QAPI Attendance Sheet dated 12/20/24 (Review of November 2024 data) In Attendance: Medical Director, Facility Administrator Additional Attendees (Kathy Lee) The Biomed, Social Worker, and Registered Dietician were not in attendance. Hospitalizations: Incenter hemodialysis -4, involving 3 patients Readmissions/Causes: 3 cases: Hill x 2, Dees x 1 There was no documentation found that indicated the reason for the hospitalizations. There was no documentation found that the facility conducted a root cause analysis of the hospitalizations. There was no documentation found that the facility developed action plans to minimize hospitalizations. Review of Technical Section of QAPI revealed the following areas blank. There was no documentation found that the facility discussed the following areas. Water cultures reviewed and signed by medical director: BLANK Trends in cultures reviewed: BLANK Total number positive cultures: BLANK RO logs completed and signed: BLANK AAMI (quarterly) reviewed and signed by Medical Director: (BLANK) Review of C &C Log for every 4 hour check: BLANK Total Preventative maintenance completed: BLANK Total work order for machine repair: BLANK QAPI Attendance Sheet dated 11/22/24 (Review of October 2024 data) In Attendance: Medical Director, Facility Administrator Social Worker Registered Dietician Additional Attendees (Kathy Lee) The Biomed was not in attendance. Hospitalizations: Incenter hemodialysis-6, involving 4 patients Readmissions/Causes: 0 There was no documentation found that indicated the reason for the hospitalizations. There was no documentation found that the facility conducted a root cause analysis of the hospitalizations. There was no documentation found that the facility developed action plans to minimize hospitalizations. Review of Technical Section of QAPI revealed the following areas blank. There was no documentation found that the facility discussed the following areas. Water cultures reviewed and signed by medical director: BLANK Trends in cultures reviewed: BLANK Total number positive cultures: BLANK RO logs completed and signed: BLANK AAMI (quarterly) reviewed and signed by Medical Director: (BLANK) Review of C &C Log for every 4 hour check: BLANK Total Preventative maintenance completed: BLANK Total work order for machine repair: BLANK QAPI Attendance Sheet dated 11/08/24 (Review of September 2024 data) In Attendance: Medical Director, Facility Administrator Social Worker Additional Attendees (Nurse Practitioner) The Biomed and Registered Dietician were not in attendance. An interview conducted with the facility administrator on 2/04/25 at 11:30 a.m. following her own review of the findings confirmed the above. The facility administrator stated that diagnosis breakdown for hospitalizations was not discussed in QAPI. At the time of the interview no evidence of compliance was presented where non-compliance was found.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 30377 Based on review of Quality Assessment and Improvement Performance (QAPI) meeting minutes and staff interview the facility failed to identify opportunities for improvement, develop and implement performance improvement plans, and evaluate the data collected for revision of improvement plans as necessary until resolved. These deficient practices identified have the potential to cause harm to all patients at the facility. Findings were: Review of Quality Assessment and Improvement Performance meeting minutes from September 2024 to January 2025 on 2/4/25 in the facility’s conference room revealed the following: The facility did not complete a QAPI meeting in the month of October 2024 and January 2025. Review of QAPI attendance sheets for the months reviewed did not reflect that all mandatory members participated in the meetings. The facility failed to complete infection control surveillance to identify areas for improvement in infection control practices. The following was observed: QAPI Attendance Sheet dated 12/20/24 (Review of November 2024 data) In Attendance: Medical Director, Facility Administrator Additional Attendees (Kathy Lee) The Biomed, Social Worker, and Registered Dietician were not in attendance. Infection Control Audits Completed: Current Month and Past Month: BLANK Handwashing / Access Care / PPE USE: BLANK Patient Education: Current Month: BLANK Staff Education: Current Month and Past Month: BLANK Internal Audits Completed: Water temperature: BLANK Infection Control: BLANK Dialysis Station Cleaning: BLANK Medication Prep: BLANK QAPI Attendance Sheet dated 11/22/24 (Review of October 2024 data) In Attendance: Medical Director, Nurse Manager Social Worker Registered Dietician Additional Attendees (Kathy Lee) The Biomed was not in attendance. Infection Control Audits Completed: Current Month and Past Month: BLANK Handwashing / Access Care / PPE USE: BLANK Patient Education: Current Month: Disaster Preparedness-30/32 HD patients completed. Staff Education: Current Month and Past Month: BLANK Internal Audits Completed: Water temperature: BLANK Infection Control: BLANK Dialysis Station Cleaning: BLANK Medication Prep: BLANK QAPI Attendance Sheet dated 11/08/24 (Review of September 2024 data) In Attendance: Medical Director, Nurse Manager Social Worker Additional Attendees (Nurse Practitioner) The Biomed and Registered Dietician were not in attendance. Infection Control Audits Completed: Current Month and Past Month: BLANK Handwashing / Access Care / PPE USE: BLANK Patient Education: Current Month: BLANK Staff Education: Current Month and Past Month: BLANK QAPI Attendance Sheet dated 09/20/24 (Review of August Data) In Attendance: Medical Director, Facility Administrator Social Worker Registered Dietitian Additional Attendees (Nurse Practitioner) The Biomed, Social Worker, and Registered Dietician were not in attendance. Infection Control Audits Completed: Current Month and Past Month: BLANK Handwashing / Access Care / PPE USE: BLANK Patient Education: Current Month: BLANK Staff Education: Current Month and Past Month: BLANK Internal Audits Completed: Water temperature: BLANK Infection Control: BLANK Dialysis Station Cleaning: BLANK Medication Prep: BLANK An interview conducted with the facility administrator on 2/04/25 at 11:30 a.m. following her own review of the findings confirmed the above. The facility administrator stated that she does not document infection control surveillance on the treatment floor. The facility administrator stated she would correct staff on the treatment floor when she observes a breech in infection control practices but does not record those observations or corrections. At time of the interview no evidence of compliance was presented were noncompliance was found.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 30377 Based on review of Quality Assessment and Improvement Performance meeting minutes, facility logs and staff interview the facility failed to continuously monitor its performance, take actions that result in performance improvements and track performance to ensure progress sustained. The findings included: Review of dialysis machine disinfection logs for December 2024 and January 2025 on 1/30/25 at 09:40 a.m. in the facility’s conference room revealed that high level disinfection (bleaching) of the hemodialysis machine was not documented as completed weekly. The following was observed: December 2024 high level disinfection (bleaching) of the dialysis machine documented completed on 12/2/24, 12/16/24 and 12/30/24. 12/2/24 only dialysis machine labeled #2 revealed documentation that high level disinfection occurred. 12/16/24 all dialysis machines revealed documentation that high level disinfection occurred. 12/30/24 only dialysis machines labeled #1, #3, #4, #10, and #11 revealed documentation that high level disinfection occurred. January 2025 high level disinfection (bleaching) of the dialysis machine documented completed on 1/6/25, 1/13/25 and 1/20/25. 1/06/25 only dialysis machine labeled #2 and #12 revealed documentation that high level disinfection occurred. 1/13/25 only dialysis machine labeled #8 and #11 revealed documentation that high level disinfection occurred. 1/20/25 all dialysis machines revealed documentation that high level disinfection occurred. Review of the last QAPI meeting completed in the facility dated 12/20/24 revealed the following under Technical Review: QAPI Attendance Sheet dated 12/20/24 (Review of Data) In Attendance: Medical Director, Nurse Manager Additional Attendees (Kathy Lee) The Biomed, Social Worker, and Registered Dietician were not in attendance. Technical Review: Water cultures reviewed and signed by medical director: BLANK Trends in cultures reviewed: BLANK Total number positive cultures: BLANK RO logs completed and signed: BLANK AAMI (quarterly) reviewed and signed by Medical Director: (BLANK) Review of C &C Log for every 4 hour check: BLANK Total Preventative maintenance completed: BLANK Total work order for machine repair: BLANK Interview conducted with biomed and the facility manager on 1/30/25 at 10:25 a.m. following their own review of the findings revealed that they were unaware of the discrepancies found. When asked who was responsible for review of facility logs and who completed monthly audits the biomed responded he did not know. He stated he comes to the facility with a check list of items to complete. The facility manager stated she does not review facility logs. The biomed also stated he did not know how to complete a facility audit. On 1/30/25 approximately 10:35 AM spoke with Biomed Operation Manager that stated the biomed was responsible for facility log audits. The biomed stated he never attends QAPI meetings.”

“PQ-PCT-STATE REQUIREMENTS & HS DIPLOMA CFR(s): 494.140(e)(1),(2) Patient care dialysis technicians must- (1) Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician; and (2) Have a high school diploma or equivalency; This Standard is not met as evidenced by: 50181 Based on employee file review and staff interview the facility failed to follow state and federal requirements in the standards of practice by direct patient care staff. The findings include: During review of employee file on 02/04/2025 it was noted 5 of 5 patient care technicians working in the facility did not have the facility medical director delegation to administer heparin, lidocaine, normal saline, and oxygen to patients as per state requirements. 8 of 8 direct patient care staff did not have proof of annual water competencies. Staff #7 (CCHT) did not have an annual clinical skills checklist completed. The last annual skills checklist on file was dated 4/26/2023. Facility Administrator (Staff #2) who serves as back-up peritoneal dialysis (PD) nurse does not have current PD skills competencies. The last PD skills competency completed on file was dated 10/18/2022. The Facility Administrator confirmed the above findings during an interview on 02/05/2025.”

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 30377 Based on review of Quality Assessment and Improvement Performance (QAPI) meeting minutes and staff interview the Medical Director failed to ensure that monthly QAPI meetings were held and that required staff attend and participate in the QAPI meetings. The medical director failed to ensure that the facility identify opportunities for improvement, develop and implement performance improvement plans, and evaluate the data collected for revision of improvement plans as necessary until resolved. These deficient practices identified have the potential to cause harm to all patients at the facility. The findings included: Review of Quality Assessment and Improvement Performance meeting minutes from September 2024 to January 2025 on 2/4/25 in the facility’s conference room revealed the following: The facility did not complete a QAPI meeting in the month of October 2024 and January 2025. Review of QAPI attendance sheets for the months reviewed did not reflect that all mandatory members participated in the meetings. The facility failed to complete infection control surveillance to identify areas for improvement in infection control practices. The facility failed to conduct a root cause analysis and develop action plans to minimize hospitalizations. Review of Technical Section of QAPI revealed the following areas blank. There was no documentation found that the facility discussed the following areas. Water cultures reviewed and signed by medical director: BLANK Trends in cultures reviewed: BLANK Total number positive cultures: BLANK RO logs completed and signed: BLANK AAMI (quarterly) reviewed and signed by Medical Director: (BLANK) Review of C &C Log for every 4 hour check: BLANK Total Preventative maintenance completed: BLANK Total work order for machine repair: BLANK An interview conducted with the facility administrator on 2/04/25 at 11:30 a.m. following her own review of the findings confirmed the above. At the time of the interview no evidence of compliance was presented where non-compliance was found.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 30377 Based on review of Quality Assessment and Improvement Performance (QAPI) meeting minutes and staff interview the Governing Body failed to ensure that monthly QAPI meetings were held and that required staff attend and participate in the QAPI meetings. The Governing Body failed to ensure that the facility identify opportunities for improvement, develop and implement performance improvement plans, and evaluate the data collected for revision of improvement plans as necessary until resolved. These deficient practices identified have the potential to cause harm to all patients at the facility. The findings included: Review of Quality Assessment and Improvement Performance meeting minutes from September 2024 to January 2025 on 2/4/25 in the facility’s conference room revealed the following: The facility did not complete a QAPI meeting in the month of October 2024 and January 2025. Review of QAPI attendance sheets for the months reviewed did not reflect that all mandatory members participated in the meetings. The facility failed to complete infection control surveillance to identify areas for improvement in infection control practices. The facility failed to conduct a root cause analysis and develop action plans to minimize hospitalizations. Review of Technical Section of QAPI revealed the following areas blank. There was no documentation found that the facility discussed the following areas. Water cultures reviewed and signed by medical director: BLANK Trends in cultures reviewed: BLANK Total number positive cultures: BLANK RO logs completed and signed: BLANK AAMI (quarterly) reviewed and signed by Medical Director: (BLANK) Review of C &C Log for every 4 hour check: BLANK Total Preventative maintenance completed: BLANK Total work order for machine repair: BLANK An interview conducted with the facility administrator on 2/04/25 at 11:30 a.m. following her own review of the findings confirmed the above. At the time of the interview no evidence of compliance was presented where non-compliance was found.”