Shifa Dialysis

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 39802 Based on document review and interview, the Facility failed to ensure that the emergency plan was updated based on a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. Findings include: 1. The Facility’s policy titled, “Emergency Preparedness” (effective 06/01/2014), was reviewed and required, “...This emergency management program will establish specific measures that will minimize risk to lives, enable the facility to prevent and/or minimize damages, and quickly resume operations, using internal resources and expertise. The plan should include provisions to: ...Comply with federal, state, and local laws and regulations...” 2. The Facility’s Emergency Preparedness and Emergency Plans Binder was reviewed on 08/20/2025. The binder included a last emergency plan updated on 01/31/2025; however, lacked documentation of a hazard vulnerability risk assessment. 3. During an interview with the Nurse Manager (E#1) on 08/20/2025, at approximately 12:52 PM, E#1 stated that they have not yet completed the hazard-vulnerability risk assessment. E#1 showed in the computer system, that a risk assessment was created on 10/8/2024 but was not yet completed. E#1 stated that they did not complete risk assessments prior to the one started in October 2024.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(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. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, for 1 of 1 emergency cart, the Facility failed to ensure that emergency equipment included a functional suction machine that would be available for immediate use and that emergency cart checks were completed daily as required by policy. Findings include: 1. The Facility’s policy titled, “Emergency Crash Cart Checks” (effective 06/01/2024), was reviewed and required, “The facility will perform emergency crash cart checks to ensure that the emergency cart is adequately supplied, medications are current, and emergency equipment is functioning safely and properly... The Director of Nursing will ensure daily crash cart checks are completed...” 2. Emergency Crash Cart Checklists from June to August 2025 were reviewed on 08/20/2025. The logs lacked documentation of daily checks from 06/16/2025-07/31/2025 and from 08/11/2025-08/19/2025. The logs did not include any documentation that the suction machine was out of service or needed repair/part replacement. 3. During a tour of the dialysis clinic on 08/20/2025, between approximately 10:30 AM and 1:30 PM, there was a portable suction machine noted on the bottom shelf of the emergency cart. The suction machine had no power cord and the suction machine had no power when turned on (battery drained). 4. An interview was conducted with the Nurse Manager/Director of Nursing (E#1) on 08/20/2025, at approximately 1:00 PM. E#1 stated that there was an issue with the power cord and they had put an order in for a new one earlier this month. E#1 could not provide any records that they ordered a new cord for the suction machine.”

“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, for 1 of 1 Nurse (E#1), the Facility failed to ensure that the diluted bleach solution used for disinfecting contaminated surfaces was replaced daily to ensure its effectiveness. Findings include: 1. The Facility’s policy titled, “Mixing Bleach Solution” (effective 06/01/2014), was reviewed and required, “...Any unused bleach solution should be discarded at the end of the day and fresh solution should be mixed daily in the morning. Bleach will lose its disinfectant properties after 24 hours...” 2. During a tour of the home dialysis rooms on 08/20/2025, between approximately 11:00 AM and 12:30 PM, a spray bottle was labeled to contain a solution of diluted bleach. The bottle did not include the date that the solution was mixed. 3. An interview was conducted with the Nurse Manager (E#1) on 08/20/2025, at approximately 1:00 PM. E#1 stated that they use the bottle to clean the chairs, table, and counters after a patient has used the room. E#1 stated that they replaced the solution every week.”

“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: 39802 Based on document review and interview, for 1 of 2 patient (Pt. #2) on continuous cycling peritoneal dialysis (CCPD), the Facility failed to ensure that patient’s blood pressure was monitored during treatment per policy. Findings include: 1. The Facility’s policy titled, “The Facility’s policy titled, “Home Peritoneal Patient Record Keeping” (effective 11/08), was reviewed and required, “...Train patients and/or patient helpers to complete blood pressure, weight and effluent measurement and to fill out home treatment log sheets as part of home dialysis training... Patients will document treatments on paper treatment logs or on data cards. Document review of log in progress notes as part of monthly clinic visit.” 2. The clinical record of Pt. #2 was reviewed on 08/20/2025. Pt. #2 was admitted on 08/22/2023 with a diagnosis of end-stage renal disease. A physician’s order, dated 09/17/2024, included to complete CCPD 7 days per week. Treatment records from 05/24/2025-08/20/2025 were reviewed and lacked documentation of blood pressure on most treatment days (only 7 days of treatments during this period had recorded blood pressures). The record lacked any documentation prior to start of survey (08/20/2025) of any education or any additional interventions to address the lack documented blood pressures. 3. An interview was conducted with the Nurse Manager (E#1) on 08/21/2025, at approximately 10:00 AM. E#1 stated that patients should be documenting pre and post blood pressures. E#1 stated that E#1 tries to remind them every month to complete it. E#1 stated that for patients on CCPD, the data uploads automatically to the system so E#1 can see the data remotely.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 39802 Based on document review and interview, for 3 of 4 patients’ (Pts. #1, #3, and #4) plans of care reviewed, the Facility failed to ensure that all members of the interdisciplinary team (IDT) signed the plan of care. Findings include: 1. The Facility’s policy titled, “Plan of Care” (revised 04/12), was reviewed and required, “...The team consists of: Primary dialysis physician, Registered nurse, Dietician, Master social worker, and Patient... The patient’s signature of the care plan should be attained prior to the plan’s implementation...” 2. The clinical records for the following were reviewed on 08/20/2025 and 08/21/2025 and indicated the following: - Pt. #1 was admitted on 04/13/2022 with a diagnosis of end-stage renal disease (ESRD). The record indicated that an annual plan of care meeting was completed on 09/01/2024; however, the record lacked signatures from all IDT members, including the physician, nurse, dietician, social worker, and the patient. - Pt. #3 was admitted on 02/01/2023 with a diagnosis of ESRD. The record indicated that an annual plan of care meeting was completed on 06/01/2024; however, the record lacked signatures from the dietician, social worker, and the patient. - Pt. #4 was admitted on 03/19/2025 with a diagnosis of ESRD. The record indicated that an initial plan of care meeting was completed; however, the record lacked signatures from all IDT members. 3. An interview was conducted with the Nurse Manager (E#1) on 08/21/2025, at approximately 11:00 AM. E#1 stated that all team members are generally present for the plan of care meeting in person, except for the social worker who attends remotely. E#1 stated that they print out the signature sheet after having the meeting but sometimes the staff forget to sign. E#1 keeps the unsigned forms in a folder for documents that need to be signed.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 39802 Based on document review and interview, for 2 of 2 patients (Pts. #3 and #4) reviewed for continuous ambulatory peritoneal dialysis (CAPD), the Facility failed to retrieve and review dialysis treatment data from self-care patients at least every 2 months. Findings include: 1. The Facility’s policy titled, “Home Peritoneal Patient Record Keeping” (effective 11/08), was reviewed and required, “...Patients and/or patient helpers will be taught to maintain a daily record of home dialysis treatments... Teach patients to bring the binder and completed home training log sheets to the Home Dialysis unit for monthly clinic visits to be reviewed by Home Program nursing staff and/or physicians... Patients will document treatments on paper treatment logs or on data cards. Document review of log in progress note as part of monthly clinic visit...” 2. The clinical record of Pt. #3 was reviewed on 08/20/2025. Pt. #3 was admitted on 02/01/2023 with a diagnosis of end-stage renal disease (ESRD). A physician’s order, dated 03/14/2025, included to complete CAPD 7 days per week, with 3 exchanges each treatment. The record lacked any home treatment records completed after 04/20/2025. Monthly nursing progress notes completed from May 2025-current were reviewed and lacked documentation of efforts by staff to obtain these records. 3. The clinical record of Pt. #4 was reviewed on 08/20/2025. Pt. #4 was admitted on 03/19/2025 with a diagnosis of ESRD. A physician’s order, dated 04/22/2025, included to complete CAPD 7 days per week, with 2 exchanges each treatment. The record lacked any home treatment records completed after 05/07/2025. Monthly nursing progress notes completed from May 2025-current were reviewed and lacked documentation of efforts by staff to obtain these records. 4. An interview was conducted with the Nurse Manager (E#1) on 08/20/2025, at approximately 3:30 PM. E#1 stated that E#1 has been trying to tell the patients to bring they’re treatment records in but they keep forgetting.”

“H-MONITOR HOME ADAPT;HOME VISIT=POC CFR(s): 494.100(c)(1)(i) Services include, but are not limited to, the following: (i) Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. This Standard is not met as evidenced by: 39802 Based on document review and interview, for 3 of 4 patient (Pts. #1-#3) records reviewed, the Facility failed to ensure that home visits were conducted annually as required by policy. Findings include: 1. The Facility’s policy titled, “Home Visit Guidelines” (effective 11/08) was reviewed and required, “Home visits will be performed initially, annually and as necessary... After the home visit, staff will document findings in the patients’ record.” 2. The clinical records of the following patients were reviewed on 08/20/2025: - Pt. #1 was admitted on 04/13/2022 with a diagnosis of end-stage renal disease (ESRD). The record lacked documentation of an annual home visits from initial home visit through 8/20/2025. - Pt. #2 was admitted on 08/22/2023 with a diagnosis of ESRD. The record lacked documentation of an annual home visits from initial home visit through 8/20/2025. - Pt. #3 was admitted on 02/01/2023 with a diagnosis of ESRD. The record lacked documentation of an annual home visits from initial home visit through 8/20/2025. 3. An interview was conducted with the Nurse Manager (E#1) on 08/20/2025, at approximately 10:45 AM. E#1 stated that they do home visits initially before the patient goes home to do treatments and then at least annually thereafter.”

“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: 39802 A. Based on document review and interview, the Facility’s Quality Assessment and Performance Improvement program failed to include monitoring of fluid & BP management, transplant referrals, and the results of the Health outcomes-physical and mental functioning (HRQOL) assessments, and physical plant safety rounds. Findings include: 1. The Facility’s policy titled, “Quality Improvement Program” (revised 03/14), was reviewed and required, “...Quality measures will include the following: ... Management of complications... Environmental safety... Management of patient education...” The policy did not specifically address transplant referrals, HRQOL assessments, fluid & BP management...” 2. Monthly Quality Assessment and Performance Improvement (QAPI) Meeting Minutes from February to July 2025 were reviewed on 08/21/2025 and lacked documentation that data for transplant referrals, HRQOL assessments, environmental/physical plant safety rounds, and fluid & BP management was discussed and analyzed. 3. An interview was conducted with the Nurse Manager (E#1) on 08/21/2025, at approximately 10:45 AM. E#1 stated that the social worker attends these meetings and will bring up any concerns regarding transplants or HRQOL assessments; however, they are not discussed or included in the minutes on a regular basis. E#1 stated that they do not cover topics of environmental safety or have specific data regarding BP and fluid management in the QAPI meetings. 4. A telephone interview was conducted with the Social Worker (E#3) on 08/21/2025, at approximately 11:50 AM. E#3 stated that E#3 tracks the information for transplant referrals and completion rates for the HRQOL assessments; however, they have not included the specific information in the QAPI minutes but they should going forward. B. Based on document review and interview, for 1 of 1 death (Pt. #5) that occurred between February 2025-08/19/2025, the Facility failed to ensure that a mortality review was completed for each death in order to measure, analyze, and track for possible trends. Findings include: 1. The Facility’s policy titled, “Quality Improvement Program” (revised 03/14), was reviewed and required, “...Quality measures will include the following: ... Review of hospitalizations and deaths...” 2. The clinical record of Pt. #5 was reviewed on 08/21/2025. Pt. #5 was admitted for home peritoneal dialysis on 11/26/2024 with a diagnosis of end-stage renal disease. The record indicated that Pt. #5 expired due to intraoperative myocardial infarction (heart attack) on 02/10/2025. 3. Monthly Quality Assessment and Performance Improvement (QAPI) Meeting Minutes from February to July 2025 were reviewed on 08/21/2025 and lacked documentation of any deaths. The February 2025 meeting minutes indicated that Pt. #5 “left the facility” and there was no documentation of a mortality review to analyze for potential contributing factors. 4. An interview was conducted with the Nurse Manager (E#1) on 08/21/2025, at approximately 10:45 AM. E#1 stated that they discussed the fact that Pt. #5 had expired due to cardiac arrest during a surgical procedure. E#1 stated that they did not review any other information regarding Pt. #5’s death. E#1 did not know what surgical procedure Pt. #5 had when Pt. #5 expired and why Pt. #5 was in the hospital at the time having the surgery.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, for 3 of 3 home dialysis training rooms and 1 of 1 laboratory area, the Facility failed to ensure that outdated supplies and/or medications were discarded. Findings include: 1. The Facility’s policy titled, “Control and Storage of Medications” (effective 11/08), was reviewed and required, “Medication inventory is to be checked monthly. Assess for: a. Discontinued, unused medication; b. Expired (outdated) medication... e. Containers with worn, illegible, damaged, incomplete, or missing labels... Discard medication if: a. Expired; b. Opened without completed date and/or initials; c. Opened for longer than 30 days... for multi-dose vials...” 2. During a tour of the home dialysis clinic on 08/20/2025, between approximately 10:30 AM and 1:30 PM, the following was observed: - an opened and undated vial of heparin (blood thinner) - five bottles of opened and undated skin disinfectant (with a shelf life of 6 months after opening) - two bottles of hand sanitizer in the laboratory area that expired on 03/14/2025 - multiple expired needles, vacutainers for blood draws, syringes, alcohol wipes, and laboratory tubes in home training rooms and the laboratory area with expiration dates ranging from January 2024 to July 2025. 3. An interview was conducted with the Nurse Manager (E#1) on 08/20/2025, at approximately 11:30 AM. E#1 stated that E#1 usually checks monthly for outdated supplies and medications. E#1 stated that multi-dose medication vials should be labeled with the opened date since they are only good for 30 days after opening. E#1 stated that E#1 will discard the expired supplies. 4. A telephone interview was conducted the Medical Director (MD#1) on 08/21/2025, at approximately 11:38 AM. MD#1 stated that staff are expected to follow the Facility’s policies and procedures.”

“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: 40079 Based on document review and interview, it was determined that for 1 of 1 (Pt. #2) peritoneal dialysis (PD) clinical record reviewed, the facility failed to ensure that the dialysis prescription was followed as ordered. Findings include: 1. The clinical record of Pt. #2 was reviewed on 03/07/2024. Pt. #2 was admitted on home peritoneal dialysis (PD) on 03/07/2023 with a diagnosis of ESRD (end stage renal disease). A physician’s order dated 02/22/2024, included a home PD treatment order for CCPD (Continuous Cycling Peritoneal Dialysis), 7 treatments per week, with dwell of 2 hours ... Fill volume of 2000. Pt #2’s home treatment flowsheets for 02/23/2024 through 02/29/2024 and 03/01/2024 through 03/06/2024 were reviewed, Pt. #2 did not receive PD treatment for the following dates: 02/23/24, 02/25/24, 02/28/24, and 03/03/24. The Pt. #2’s clinical record lacked documentation of a reason for missed treatments. 2. The facility’s policy titled, “PD Procedures General Instructions” (revised 11/01/2018) was reviewed and required, “ ... A physician will prescribe the correct number of exchanges or cycles according to your body size and residual renal function ... This procedure is performed only by a nurse, patient ... who has been trained by the home training dialysis staff ... All home PD records are to be maintained per training instructions ...” 3. On 03/07/2024 at approximately 1:30 PM, an interview was conducted with the Clinical Nurse Manager (E #1). E #1 stated that when the peritoneal dialysis cycler (machine used to remove waste products from blood) is programmed by (E #1) and must be followed according to the doctors’ orders. E #1 confirmed that (Pt. #2) has missed several dialysis treatments.”

“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: 40079 Based on document review and interview, it was determined for 1 of 3 (Pt. #2) clinical records reviewed, the facility failed to ensure the patient’s weight and blood pressure were monitored during treatment per policy. Findings include: 1. The facility’s policy entitled, “Home Peritoneal Patient Record Keeping” (revised 11/01/2014) required, “... 1. Train patients and/or patient helpers to complete blood pressure, weight ... and to fill out home treatment log sheets as part of home dialysis training ...” 2. The clinical record for Pt #2 was reviewed on 03/07/2024. Pt #2 was admitted on 03/07/2023 with a diagnosis of ESRD (end stage renal disease). Pt #2’s home treatment flowsheets for 02/01/2024 - 03/07/2024, were reviewed and lacked documentation of weight and blood pressure for every treatment. The nurses’ notes did not include any discussion or reeducation with Pt #2, about incomplete documentation about importance of monitoring blood pressure, heart rate, and weight pre and post dialysis treatment and appropriateness of treatment. 3. On 03/07/2024 at 1:25 PM, an interview was conducted with the Clinical Nurse Manager (E #1). E #1 stated that patients are all trained on how to complete the home treatment form and they are supposed to record blood pressure and weight before and after every treatment, this information is important to evaluate appropriateness of the treatment.”