Davita South Shore Dialysis Center

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 22676 Based on observation, interview, and policy review, the facility failed to restrict access to the water purification and storage system to only individuals responsible for monitoring and maintenance of the system on one of three survey days. Failure to restrict access to the water purification and storage system to only individuals responsible for monitoring and maintenance of the system had the potential to negatively impact the safety and well-being of the 55 in-center dialysis patients receiving treatments at this facility. Findings include: During tour of the facility on 02/28/24 at 1:30 PM, the door leading to the water purification system and the bicarb and acid storage area was observed wide open with no one in the water treatment area. During an interview with the Administrator on 02/28/24 at 1:30 PM, he/she confirmed the door was open and no one was in the water room. During an interview on 02/28/24 at 2:00 PM, Biomed 6 confirmed access to the water purification and storage system was not restricted to only authorized users who were responsible for the monitoring and maintaining the system. Biomed 6 stated that he must have left the door open when he/she left. Review of the facility’s policy titled, “Water Treatment System Minimum Component Requirement,” dated October 2021, indicated, “Access to the water treatment system should be restricted to those personnel/trained teammates responsible for monitoring, maintenance of the system and supply ordering.””

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 22676 Based on observation, interview, and the facility’s policy, the facility failed to ensure the staff monitored the end of day hardness of water quality by failing to ensure one of one water hardness strips were not expired. This deficient practice had the potential to affect the water quality of the all 55 in-center hemodialysis patients receiving treatment and staff at this facility. Findings include: Observation in the water treatment area on 02/28/24 at 1:30 PM, revealed one bottle of RPR, [sic]lot #108041, water hardness test strips expired on 05/31/23. The bottle was dated by unknown staff, as being opened on 12/29/23. The date of opening was recorded but not initialed with the staff initials. During an interview on 02/28/24 at 1:30 PM, the Administrator confirmed the manufactures expiration date was 05/31/23 and the bottle was opened for use on 12/29/23. The Administrator confirmed there was not another opened bottle and this bottle had only three test strips left which indicated it had been used since the date of opening on 12/29/23 and expired 02/29/23. A review of the facility’s policy titled, “Hardness Test Using RPC Water Hardness Test Strips” dated 10/21, revealed, “Do not use test strips after the manufacturing expiration date which is printed on the bottle.””

“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: 22676 Based on review of glucometer logs, interview, facility policy review, and review of manufacturer’s instructions, the facility failed to ensure the glucometers were in the control range and follow manufacturer’s instructions for one of one glucometer used in the facility. This had the potential to provide inaccurate glucose results that could result in mistreated blood glucose levels to all 69 patients receiving care at the facility. Findings include: Review of “Blood Glucose Logs” provided by the Administrator, for glucometer E19LA01248, from 01/01/24 through 02/27/24, revealed the acceptable low blood glucose control range should be 92-124. On 01/30/24, the recorded low control was 127. During an interview on 02/28/24 at 2:00 PM, with Clinical Coordinator 3, he/she confirmed the staff did not repeat calibration of the abnormal low testing level. Review of the facility’s policy titled, “Embrace PRO Blood Glucose Monitoring System Quality Control” dated September 2020, revealed, “. . . 16. If control results fall outside the acceptable range the test must be repeated.” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/2020 revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””

“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: 22676 Based on record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for four of six sampled in-center patients (Patient (P) 7, P9, P10 and P12). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the all 55 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P7’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) 350 milliliters per min (ml/min) and the dialysis flow rate (DFR) was 500 ml/min. Review of one of six “Post Treatment” flowsheets from 02/12/24 through 02/28/24, in the EMR indicated the following: a. On 02/24/24, the BFR was documented at 300 ml/min and the DFR was documented at 800 ml/min from 7:32 AM until 11:23 AM. There was no documented rationale for the change to the prescribed BFR. 2. Review of P9’s EMR revealed a prescribed DFR was 500 ml/min. Review of one of five “Post Treatment” flowsheets from 02/15/24 through 02/24/24, in the EMR indicated the following: a. On 02/24/24, the DFR was documented at 800 ml/min from 10:44 AM until 2:16 PM. There was no documented rationale for the change to the prescribed BFR. 3. Review of P10’s EMR revealed a prescribed DFR was 500 ml/min. Review of one of six “Post Treatment” flowsheets from 02/13/24 through 02/25/24, in the EMR indicated the following: a. On 02/25/24 DFR was documented at 800 ml/min from 7:17 PM until 1:20 AM. There was no documented rationale for the change to the prescribed BFR. 4. Review of P12’s EMR revealed a prescribed BFR 400 ml/min and the DFR was 800 ml/min. Review of one of six “Post Treatment” flowsheets from 02/16/24 through 02/28/24, in the EMR indicated the following: a. On 02/28/24, the BFR was documented at 350 ml/min from 11:02 AM until 2:16 PM and the DFR was documented at 700 ml/min from 12:02AM until 2:16 PM. There was no documented rationale for the change to the prescribed BFR. During an interview on 02/29/24 at 1:30 PM, Clinical Coordinator 3 confirmed the above findings and confirmed that staff did not follow the physician order for dialysis treatment. Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Assessment,” dated 10/23, revealed, “The Nursing assessment will be performed and documented ...Verification of the prescription including machine parameters ...””

“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: 22676 Based on record review, interviews, and review of the facility’s policy, the facility failed to ensure four of six patients (Patient (P) 8, P9, P10, and P11) reviewed, participated in the plan of care (POC), or received the information within a timely manner. Failure to ensure the patients reviewed the POC and understand the goals set had the potential to negatively impact the effectiveness of the dialysis treatments for the 69 patients receiving dialysis treatments at this facility. Findings include: 1. Review of P8’s 30-day POC in the electronic medical Record (EMR) under the “Plan of Care” section, dated 06/06/23 revealed the patient was not provided with the information in the POC until 07/11/23. 2. Review of P9’s 30-day POC, EMR under the “Plan of Care” section, dated 12/19/23, revealed the facility failed to ensure the patients signature was dated to indicate if the information in the POC was provided within a timely manner. Review of the 90-day POC for P8 dated 02/08/24 the form the patient sign was also left blank. There was no evidence that the POC information for the initial 30-day POC or the 90-day POC was provided to P9 in a timely manner. 3. Review of P10’s 90-day POC, in the EMR under the “Plan of Care” section, dated 01/26/24, revealed the facility failed to document evidence P10 POC information was provided to the patient. The date for the patient to sign was left blank and there was no notation in the medical record that indicated the information was provided to the patient. 4. Review of P11’s POC in the EMR under the “Plan of Care” section the unstable POC dated 10/31/23 revealed the patient was not provided with the information until 11//20/23. During an interview on 02/29/24 at 1:30 PM, Clinical Coordinator 3 confirmed the facility failed to show the POC information was provided to the patients in a timely manner for P8, P9, P10 and P11. Review of the facility’s form tilted “Patient Plan of Care” “ stated “ ...the form required a patient signature and date when the plan was reviewed, and the patient understood the plan...” Review of the facility’s policy titled, “Interdisciplinary Team (IDT) patient assessment and Plan of Care” dated 07/23, indicated, “. . . “The patient’s plan of care will be signed by all members of the IDT.””

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 22676 Based on record review, interviews, and review of the facility’s policy, the facility failed to ensure one of six patients (Patient (P) 9) 30-day plan of care (POC) was not completed within 13 treatments or 30 days as required by federal regulations. Failure to ensure the POC was completed within the first 13 treatments or within 30 days of admission had the potential to negatively impact the effectiveness of the dialysis treatments for all 69 patients receiving dialysis at this facility. Findings include: Review of P9’s electronic medical record (EMR) revealed the patient was admitted on 09/20/23. Review of the EMR under the “Plan of Care” section indicated that the facility failed to conduct a POC meeting within 13 treatments or 30 days as required. According to the EMR, the POC the 30-day meeting was not held until 12/19/23. In addition, there was no documented evidence that the information was provided to the patient as of 02/29/24. During an interview on 02/29/23 at 130 PM, Clinical Coordinator 3 confirmed the patient was admitted on 09/20/23 and the POC meeting was not held until 12/19/23. Clinical Coordinator 3 confirmed the staff did not follow the Federal Regulations and facility policy. Review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” dated 7/23 states ...”An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days or 13 outpatient dialysis sessions for hemodialysis beginning with the first outpatient dialysis treatment or per state guidelines.””

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 22676 Based on medical record reviews, interviews, and review of the facility’s policy and the Comprehensive Interdisciplinary Assessment and Plan of Care form, the facility failed to ensure two of six patients (Patient (P)7 and P9) plan of care (POC), was completed within 15 days of the reassessment as required by federal regulations. Failure to ensure the POC was developed using current assessment information had the potential to negatively impact the effectiveness of the dialysis treatments for all 69 patients receiving dialysis at this facility. Findings include: 1. Review of P7’s POC in the electronic medical record (EMR) under the “Plan of Care” section, indicated that the POC meeting was held on 09/20/23 the Registered Dietician (RD) completed the assessment on 08/09/23, the Social Worker (SW) on 08/15/23 and the Registered Nurse (RN) on 08/26/23. All assessments were conducted more than 15 days before the POC meeting and there was no evidence of an update. 2. Review of P9’s initial 30-day POC in the EMR under the “Plan of Care” section indicated that the POC meeting was held on 12/19/23. The RN conducted the assessment on 11/16/23, the SW on 10/13/23 and the RD on 10/09/23. All assessments were conducted more than 15 days before the POC meeting and there was no evidence of an update. During an interview on 02/29/24 at 1:30 PM, Clinical Coordinator 3, confirmed the above findings. Review of the facility’s form titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/23 indicated, “Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional assessments.” Review of the facility’s policy titled, “Interdisciplinary Team (IDT) patient assessment and Plan of Care” dated 7/23, indicated,” ... the plan of care must be performed within 15 days of the completion of assessments.””