Rai Care Center

“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: 49530 Based on review of facility policies and procedures, observations, and staff interview, the facility failed to have procedures to ensure expired supplies and medications were removed from the patient supply cupboards and medication room. This failed practice had the potential to expose all 99 patients on census to expired supplies and medications. Findings are: A. Review of the facility policy titled Expiration Dates Sterile Supplies, dated 7/4/12, revealed staff were to dispose of sterile supplies that have reached the expiration date. The policy failed to include a procedure to ensure staff monitored, removed, and discarded expired sterile supplies stored in the patient supply cupboards. B. Review of the facility policy titled Medication Preparation and Administration, dated 2/6/23, revealed all medications were to be checked monthly for expiration dates and expired medications were to be removed and discarded. The policy failed to include a procedure to ensure staff monitored, removed, and discarded expired medications stored in the medication room. C. Observation of the patient hemodialysis (HD) treatment area on 3/13/25 at 1:45 PM, revealed 1 box containing 25, 22 gauge 1 ½ inch (size of needle) safety needles, with an expiration date of 11/30/23, and 1 box containing 20, 22 gauge 1 inch needles, with an expiration date of 12/3/22. D. Observation of the medication room on 3/13/25 at 3:30 PM, revealed 1 box containing 30 vials of Parsibiv (a medication used to reduce parathyroid hormone levels), 2.5 milligrams (mg)/0.5 milliliters (ml), with an expiration date of 12/2024, and 1 can of Pain Relief 4% Lidocaine spray (a medication used topically to reduce pain) with an expiration date of 11/2024. E. During staff interview on 3/13/25 at 3:50 PM, the Registered Nurse (RN) Clinical Manager confirmed these identified, expired supplies and medications, and confirmed the facility policy failed to include procedures to ensure expired supplies and medications were not avilable for staff use.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 49530 Based on review facility policies and procedures, observations, and staff interview, the facility failed to maintain a clean environment. This failed practice increased the risk of microbial growth with the potential for affecting the health and safety of all 99 patients on census. Findings are: A. Review of the facility policy and procedure titled General Cleanliness and Infection Control Guidelines, dated 11/4/24, revealed facility staff were to clean areas not assigned to contracted cleaning staff. B. Review of the facility policy and procedure titled Storage of Supplies, dated 4/5/21, revealed all supplies were to be stored in a clean environment. C. Observation of the patient hemodialysis (HD) treatment area on 3/13/25 at 1:45 PM, revealed: 1. The shelves inside 8 cupboards, where patient supplies and personal protective equipment (PPE) were stored, had a buildup of dust and debris. 2. The refrigerator had a brown sticky substance on the bottom shelf, and a sticky substance on the shelves inside the door. D. During staff interview on 3/13/25 at 3:50 PM, the Registered Nurse (RN) Clinical Manager confirmed the following unclean areas were identified in the facility’s patient HD treatment area: the shelves inside 8 cupboards, where patient supplies and PPE were stored, had buildup of dust and debris, and the refrigerator had a brown sticky substance on the bottom shelf and a sticky substance on the shelves inside the door.”

“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: 49530 Based on review of facility policies and procedures, observations, and staff interview, the facility failed to identify and remove expired EZ Blood Leak test strips (testing strips used to assess for potential blood leaks in hemodialysis (HD) machines when the HD machine blood leak alarm sounds). This failed practice had the potential to expose all 99 patients on census to undetected blood leaks during HD treatments. Findings are: A. Review of the facility policy and procedure titled Recognizing a Dialyzer Membrane Leak, dated 11/2/20, revealed blood test strips were to be used to assess if a small/minor blood leak is suspected when the hemodialysis (HD) machine blood leak alarm sounds. The facility policy and procedure failed to ensure expired HD test strips were not available for use, or used, by staff. B. Observation of the patient HD treatment area on 3/13/25 at 1:45 PM, revealed a bottle containing 29 EZ Blood Leak test strips, opened on 12/23/24, had an expiration date of 3/3/25. C. During staff interview on 3/13/25 at 3:50 PM, the Registered Nurse (RN) Case Manager confirmed the bottle of EZ Blood Leak test strips located in the patient HD treatment area were expired, and the policy and procedure failed to ensure expired blood test strips were not available for use, or used, by staff.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 48995 V504 Based on review of policies and procedures, record review, and staff interviews, facility Patient Care Technicians (PCTs) failed to follow the facility’s policy and procedure for notification of a Registered Nurse (RN) when patient Blood Pressure (BP) readings, taken during hemodialysis (HD) treatment, were not within the facility policy’s parameters for 1 of 5 sampled patients (Patient 5). This failed practice provided the potential for a lack of interventions by the RN to prevent negative patient outcomes associated with blood pressure changes. The facility census was 105. V638 Based on review of policies and procedures, review of Quality Assurance Performance Improvement (QAPI, a data driven and proactive approach using a systematic, comprehensive, approach for maintaining and improving safety, and to identify areas of opportunity for the improvement in the provision of care, and testing of interventions) monthly meeting minutes, and staff interviews, the facility failed to document QAPI meeting discussions of their Medical Record Documentation audit findings, as part of the facility’s plan of correction (POC) to correct the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23, in 3 of 3 monthly QAPI meeting minutes (11/27/23, 12/28/23, and 1/25/24). This failed practice prevented the Medical Director from being involved in adjusting the facility’s POC, if needed, to ensure ongoing correction, by facility staff, of the deficient practices cited at V504 on 10/20/23. The facility census was 105. V712 Based on review of policies and procedures, review of Quality Assurance Performance Improvement (QAPI, a data driven and proactive approach using a systematic, comprehensive, approach for maintaining and improving safety, and to identify areas of opportunity for the improvement in the provision of care, and testing of interventions) monthly meeting minutes, and staff interviews, the Medical Director failed to ensure review, discussion, and evaluation of the facility’s Medical Record Documentation audit findings, as part of the facility’s plan of correction (POC) to correct the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23, was included in 3 of 3 monthly QAPI meeting minutes (11/27/23, 12/28/23, and 1/25/24). This failed practice prevented the Medical Director from being involved in adjusting the facility’s POC, if needed, to ensure ongoing correction, by facility staff, of the deficient practices cited at V504 on 10/20/23. The facility census was 105. V713 Based on review of policies and procedures, review of Quality Assurance Performance Improvement (QAPI, a data driven and proactive approach using a systematic, comprehensive, approach for maintaining and improving safety, and to identify areas of opportunity for the improvement in the provision of care, and testing of interventions) monthly meeting minutes, and staff interviews, the Medical Director failed to ensure facility staff provided and documented staff education on facility policies that were part of the facility’s plan of correction (POC) to ensure permanent correction of the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23. The facility census was 105. V715 Based on review of policies and procedures, record review, and staff interviews, the Medical Director (MD) failed to ensure facility staff followed the facility’s policies and procedures for Quality Assurance Performance Improvement (QAPI) as cited at Tag V638 on 2/22/24 and failed to ensure facility Patient Care Technicians (PCTs) followed the facility’s policy and procedure for notification of a Registered Nurse (RN) when patient Blood Pressure (BP) readings, taken during hemodialysis (HD) treatment, were not within the facility policy’s parameters for 1 of 5 sampled patients (Patient 5). These failed practices provided the potential for a lack of interventions by the RN to prevent negative patient outcomes associated with blood pressure changes and prevented the MD from being involved in adjusting the facility’s POC, if needed, to ensure ongoing correction, by facility staff of the deficient practices cited at V504 on 10/20/23. The facility census was 105.”

“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: 48995 Based on review of policies and procedures, review of Quality Assurance Performance Improvement (QAPI, a data driven and proactive approach using a systematic, comprehensive, approach for maintaining and improving safety, and to identify areas of opportunity for the improvement in the provision of care, and testing of interventions) monthly meeting minutes, and staff interviews, the facility failed to document QAPI meeting discussions of their Medical Record Documentation audit findings, as part of the facility’s plan of correction (POC) to correct the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23, in 3 of 3 monthly QAPI meeting minutes (11/27/23, 12/28/23, and 1/25/24). This failed practice prevented the Medical Director from being involved in adjusting the facility’s POC, if needed, to ensure ongoing correction, by facility staff, of the deficient practices cited at V504 on 10/20/23. The facility census was 105. Findings are: A. Review of the facility policy titled Quality Assessment and Performance Improvement Program, dated 5/2/22, revealed following every QAPI meeting, documentation of meeting minutes should include meeting date, time, attendance, meeting checklist for monthly topics and discussion during the meeting. B. During staff interview on 2/21/24 at 4:00 PM, the Director of Operations/Interim Facility Administrator confirmed the facility’s Medical Record Document audits were to be conducted as part of the facility’s plan of correction to ensure the deficient practices cited at V504, during a recertification survey with exit date on 10/20/23, were corrected and remained corrected. C. Review of facility monthly QAPI meeting minutes revealed no documentation of reviewing, discussing, or evaluating the facility’s 26 Medical Record Documentation audits conducted from 11/23/23 through 12/23/23. D. During staff interview on 2/21/24 at 4:00 PM, the Director of Operations/Interim Facility Administrator confirmed there was no documentation included in the 11/27/23, 12/28/23, or 1/25/24 monthly QAPI meeting minutes for the review, discussion, or evaluation of the facility’s Medical Record Documentation audits as part of the facility’s POC for V504 cited on 10/20/23. E. During staff interview on 2/22/24 at 11:15 AM, the Medical Director confirmed they were aware of the 10/20/23 recertification survey deficient practice findings cited at V504; but, could not confirm survey findings, or the facility’s POC in response to these survey findings, were discussed at the 11/27/23, 12/28/23, or 1/25/24 QAPI meetings. The Medical Director further confirmed they were not aware of any specifics regarding the facility’s Medical Record Documentation audits as part of the facility’s POC for V504 cited on 10/20/23.”

“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: 48995 Based on review of policies and procedures, review of Quality Assurance Performance Improvement (QAPI, a data driven and proactive approach using a systematic, comprehensive, approach for maintaining and improving safety, and to identify areas of opportunity for the improvement in the provision of care, and testing of interventions) monthly meeting minutes, and staff interviews, the Medical Director failed to ensure review, discussion, and evaluation of the facility’s Medical Record Documentation audit findings, as part of the facility’s plan of correction (POC) to correct the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23, was included in 3 of 3 monthly QAPI meeting minutes (11/27/23, 12/28/23, and 1/25/24). This failed practice prevented the Medical Director from being involved in adjusting the facility’s POC, if needed, to ensure ongoing correction, by facility staff, of the deficient practices cited at V504 on 10/20/23. The facility census was 105. Findings are: A. Review of the facility policy titled Quality Assessment and Performance Improvement Program, dated 5/2/22, revealed the Medical Director is the Chairperson of the QAPI Committee and is responsible for the effectiveness of the overall facility QAPI Program. The objective of the QAPI meeting is the QAPI committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care and, following every QAPI meeting, documentation of meeting minutes should include meeting date, time, attendance, meeting checklist for monthly topics and discussion of meeting. B. During staff interview on 2/21/24 at 4:00 PM, the Director of Operations/Interim Facility Administrator confirmed the facility’s Medical Record Document audits were to be conducted as part of the facility’s plan of correction to ensure the deficient practices cited at V504, during a recertification survey with exit date on 10/20/23, were corrected and remained corrected. C. Review of facility monthly QAPI meeting minutes revealed no documentation of reviewing, discussing, or evaluating the facility’s 26 Medical Record Documentation audits conducted from 11/23/23 through 12/23/23. D. During staff interview on 2/21/24 at 4:00 PM, the Director of Operations/Interim Facility Administrator confirmed there was no documentation included in the 11/27/23, 12/28/23, or 1/25/24 monthly QAPI meeting minutes for the review, discussion, or evaluation of the facility’s Medical Record Documentation audits as part of the facility’s POC for V504 cited on 10/20/23. E. During staff interview on 2/22/24 at 11:15 AM, the Medical Director confirmed they were aware of the 10/20/23 recertification survey deficient practice findings cited at V504; but, could not confirm survey findings, or the facility’s POC in response to these survey findings, were discussed at the 11/27/23, 12/28/23, or 1/25/24 QAPI meetings. The Medical Director further confirmed they were not aware of any specifics regarding the facility’s Medical Record Documentation audits as part of the facility’s POC for V504 cited on 10/20/23.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 48995 Based on review of policies and procedures, review of Quality Assurance Performance Improvement (QAPI, a data driven and proactive approach using a systematic, comprehensive, approach for maintaining and improving safety, and to identify areas of opportunity for the improvement in the provision of care, and testing of interventions) monthly meeting minutes, and staff interviews, the Medical Director failed to ensure facility staff provided and documented staff education on facility policies that were part of the facility’s plan of correction (POC) to ensure permanent correction of the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23. The facility census was 105. Findings are: A. Review of the facility policy titled Knowledge, Skills and Competency Evaluation for Clinical Staff, dated 12/12/21, revealed Fresenius Kidney Care (FKC, the facility’s owner) incorporates a team approach to education including introduction to and updating all clinical field employees on its policies and procedures. FKC provides all clinical field employees with initial and ongoing development and evaluation of the knowledge and skills essential for a highly functional and well-trained workforce. This policy did not contain a requirement for staff to document staff training provided, to include, but not limited to: training date, time, and content; trainer’s name and job title; and training attendee’s name, job title and signature to confirm their attendance at the training. B. Review of QAPI meeting minutes, dated 11/27/23, 12/28/23, and 1/25/24, revealed the QAPI meeting minutes failed to include documentation confirming the date all facility Patient Care Technicians (PCTs) and Registered Nurses (RNs) were educated/trained on the facility’s policy and procedure titled Patient Assessment and Monitoring, dated 5/1/23, as part of the facility’s POC to correct the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23. C. During staff interview on 2/21/24 at 3:00 PM, the Charge Nurse (CN) revealed the facility’s 10/23/23 training, as part of the facility’s POC to correct the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23, was not a formal staff training/education event; instead, it was a morning huddle, conducted on the treatment floor, with some of the facility’s staff present. The CN further confirmed a formal staff training event was not conducted. D. During staff interview on 2/21/24 at 4:00 PM with Facility Administrator (FA) revealed the facility was unable to provide documentation confirming the date all facility PCTs and RNs were educated/trained on the facility’s policy and procedure titled Patient Assessment and Monitoring, dated 5/1/23, as part of the facility’s POC to correct the deficient practices cited at V504 during a recertification survey with exit date on 10/20/23. E. During staff interview on 2/22/24 at 11:15 AM, the Medical Director (MD) confirmed being aware of a huddle (an informal staff meeting) attended by some staff on 10/23/23 regarding reporting vital signs outside of facility policy’s parameters to the RN; however, the MD had not seen or heard of any confirmation regarding formal education provided to all of the facility’s PCTs and RNs. F. Review of the facility policy titled Patient Assessment and Monitoring, dated 5/1/23, revealed the Patient Care Technician (PCT) must notify the RN of any patient Blood Pressures (BP) readings of systolic BP parameters greater than 180 mm (millimeters)/Mercury (Hg) or equal to or less than 100 mm/Hg and/or diastolic BP parameter greater than 100 mm/Hg during HD treatment. The PCT is also required to document the RN was notified of patient BP readings outside of the policy parameters. G. Review of Patient 5’s clinical record on 2/21/24 revealed PCTs failed to document an RN was notified for BP readings outside of policy parameters for the following HD treatments: 1. PCT-E on: 2/2/24 at 3:34 PM BP 195/98 and at 4:07 PM BP 202/97 2/12/24 at 3:11 PM BP 200/109, at 3:31 PM BP 204/101, at 4:31 PM BP 205/109, and at 5:15 PM BP 194/84 2/14/24 at 5:04 PM BP 207/99, and at 5:11 PM BP 204/100 2/16/24 at 4:33 PM 197/109 2. PCT-G on: 2/7/24 at 3:37 PM BP 194/102, and at 5:22 PM BP 201/102 2/9/24 at 2:00PM BP 186/101, at 2:30 PM BP 185/101, at 4:31 PM BP 205/103, and at 5:07 PM BP 190/104 2/19/24 at 3:04 PM BP 192/99, and at 3:30 PM BP 200/119 3. PCT-K on: 2/5/24 at 3:13 PM BP 198/103, at 4:01 PM BP 208/92, at 4:11 PM BP 193/85, and at 5:06 PM BP 133/118 2/19/24 at 1:12 PM BP 184/102 H. During staff interview on 2/21/24 at 3:00 PM, the CN confirmed facility PCTs had failed to document an RN was notified when BP readings were outside of policy parameters during HD treatments for Patient 5.”

“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: 48995 Based on review of policies and procedures, record review, and staff interviews, the Medical Director (MD) failed to ensure facility staff followed the facility’s policies and procedures for Quality Assurance Performance Improvement (QAPI) as cited at Tag V638 on 2/22/24 and failed to ensure facility Patient Care Technicians (PCTs) followed the facility’s policy and procedure for notification of a Registered Nurse (RN) when patient Blood Pressure (BP) readings, taken during hemodialysis (HD) treatment, were not within the facility policy’s parameters for 1 of 5 sampled patients (Patient 5). These failed practices provided the potential for a lack of interventions by the RN to prevent negative patient outcomes associated with blood pressure changes and prevented the MD from being involved in adjusting the facility’s POC, if needed, to ensure ongoing correction, by facility staff of the deficient practices cited at V504 on 10/20/23. The facility census was 105. Findings are: A. Review of the facility policy titled Patient Assessment and Monitoring, dated 5/1/23, revealed the Patient Care Technician (PCT) must notify the RN of any patient BP readings of systolic BP parameters greater than 180 mm (millimeters)/Mercury (Hg) or equal to or less than 100 mm/Hg and/or diastolic BP parameter greater than 100 mm/Hg during HD treatment. The PCT is also required to document the RN was notified of patient BP readings outside of the policy parameters. B. Review of Patient 5’s clinical record on 2/21/24 revealed PCTs failed to document an RN was notified for BP readings outside of policy parameters for the following HD treatments: 1. PCT-E on: 2/2/24 at 3:34 PM BP 195/98 and at 4:07 PM BP 202/97 2/12/24 at 3:11 PM BP 200/109, at 3:31 PM BP 204/101, at 4:31 PM BP 205/109, and at 5:15 PM BP 194/84 2/14/24 at 5:04 PM BP 207/99, and at 5:11 PM BP 204/100 2/16/24 at 4:33 PM 197/109 2. PCT-G on: 2/7/24 at 3:37 PM BP 194/102, and at 5:22 PM BP 201/102 2/9/24 at 2:00PM BP 186/101, at 2:30 PM BP 185/101, at 4:31 PM BP 205/103, and at 5:07 PM BP 190/104 2/19/24 at 3:04 PM BP 192/99, and at 3:30 PM BP 200/119 3. PCT-K on: 2/5/24 at 3:13 PM BP 198/103, at 4:01 PM BP 208/92, at 4:11 PM BP 193/85, and at 5:06 PM BP 133/118 2/19/24 at 1:12 PM BP 184/102 C. During staff interview on 2/21/24 at 3:00 PM, the Charge Nurse confirmed facility PCTs had failed to document an RN was notified when BP readings were outside of policy parameters during HD treatments for Patient 5. D. During staff interview on 2/22/24 at 10:30 AM, the Facility Administrator (FA) revealed the expectation of staff is to follow all facility policies and procedures. E. During staff interview on 2/22/24 at 11:15 AM, the MD revealed they had no knowledge of the facility’s PCTs continued failure to follow the facility’s policy and procedure for notification of an RN when patient BP readings, taken during hemodialysis (HD) treatment, were not within the facility policy’s parameters.”