Legacy Dialysis of Virgina, LLC

“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: 42725 Based on interview and document review, it was determined the facility’s emergency preparedness plan failed to include policies and procedures related to high risk(s) identified in the hazard vulnerability assessment. Specifically, the facility failed to have a policy and procedure in place for a pandemic and/or outbreak of an infectious disease. Findings: On 07/18/2024, the surveyor reviewed the facility’s Emergency Preparedness documents to include the hazard vulnerability assessment. The facility’s hazard vulnerability assessment was conducted on 06/18/2024 and the assessment identified a pandemic and/or outbreak of infectious disease as a high risk probability. A review of the facility’s policies and procedures did not include information related to a pandemic and/or outbreak. The surveyor discussed the information with the Director of Nursing who acknowledged that the facility had not developed a policy and procedure for a pandemic and/or outbreak after it had been identified as a high risk through the hazard vulnerability assessment.”

“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: 42725 Based on the scope and severity of deficiencies related to Emergency Preparedness, the facility failed to substantially comply with this condition. See tags: E0004, E0028, and E0036”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 42725 Based on interview and document review, it was determined the facility failed to develop and implement an emergency preparedness plan that contains all the required elements. Findings: The facility’s policy titled, “Emergency Preparedness”, reads in part: “... 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... Planning for an Emergency... The Facility will form a planning team. This will consist of the Director of Nursing, Chief Technician and an administrative person. The team will meet on a regular basis and report to the governing body of the Facility.” The facility’s policy titled, “Emergency and Disaster Responsibility” reads in part: “... I. Roles of Director or Operations / Area Manager... Prepare the Hazard vulnerability Assessment for each facility in their area with input from the facility interdisciplinary teams... Responsible for all the disaster planning and response... Medical Director: Participate in the completion of the Hazard Vulnerability Assessment annually. Attend Governing Body meeting to review and approve the Emergency Plan annually...”. The surveyor reviewed the facility’s emergency preparedness binder, which included an emergency plan. The plan was not specific to the facility; it was a template with areas to be completed by the facility; however, those areas were blank. An additional document in the binder containing the words “emergency plan” provided general guidance regarding the information and requirements for an emergency plan. It was not specific to the facility. There was no evidence of the following: the completion of a facility-based, community-based risk assessment, development of policies and procedures (shelter in place, volunteers, medical records) and required training and testing. The surveyor reviewed Governing Body meeting minutes from 01/15/2024 which indicated a review was conducted of an emergency plan. There was no documentation of what information was reviewed and if there were any updates. During the exit interview on 04/23/2024, the surveyor discussed the findings with Staff Members #1 and #6. The surveyor discussed the emergency plan, the missing information, and how it needs to be specific to the facility. Staff Members #1 and #6 verbally acknowledged the information.”

“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: 42725 Based on observation, interview and document review, it was determined the facility failed to remove expired supplies from the emergency cart and evacuation kit, ensure all the required supplies/emergency equipment were available for use, and ensure the emergency cart and evacuation kit were secured when not in use. Findings: The facility’s policy titled, “Emergency Medications, Equipment and Supplies” states in part: “... The following minimum emergency supplies and equipment must be on the premises at all times, clean, functional, accessible and immediately available: Automated External Defibrillator (AED); Oxygen, tubing...; Emergency medications...; IV solutions and administration sets... Emergency Cart... The emergency cart must be: Locked when not in use. Checked monthly or after use for contents, expiration dates... Equipped with a dedicated oxygen tank... Emergency Equipment... Note: Facilities using and Automated External Defibrillators (AED) should refer to manufacturer’s instruction regarding maintenance and testing... Emergency Evacuation Box... An emergency evacuation box must: ... Contain all patient and staff emergency contact information. Be checked monthly or after use for contents, expiration dates... An itemized log must be kept indicating the contents and expiration dates of contents...”. On 04/22/2024 at 1:30 p.m., the surveyor conducted a tour of the facility. Upon review of the emergency cart, the surveyor observed there was a lock on the side of the emergency cart with a key in it. Without turning the key, the surveyor was able to open the first drawer of the cart. A review of the contents in the emergency cart revealed the following: - One (1) set of adult electrode pads, expired 9/26/22 - One (1) suture removal kit, expired 5/30/23 - Three (3) triple antibiotic ointment packets, expired 09/22 - Five (5) tongue depressors, expired 03/2022 - One (1) 3.6 x 4 inch Mepore bandage, expired 8/28/2022 - One (1) suction catheter, expired 4/16/2023 The automated external defibrillator (AED) had a sticker indicating an inspection has been conducted on 10/02/2020 with the next inspection due 10/2021. The surveyor observed an oxygen tank regulator laying on top of the emergency cart; however, there was no oxygen tank present. While reviewing the contents of the evacuation kit, the following was discovered: - Five (5) tongue depressors, expired 03/2022 - One (1) 17 G fistula needle, expired 12/31/2023 - One (1) non-conductive suction tubing, expired 10/01/2023 - Six (6) triple antibiotic ointment packets, expired 08/2021 - Three (3) ultraclamp tubing clamp, expired 10/2022 - Eight (8) 3 ml 21 G x 1” syringe with needle, expired 12/01/2023 The surveyor requested a list of medications and supplies that should be in the emergency cart. A document titled, “Emergency Crash Cart Checklist”, was provided. The document identified the standard medications and equipment that should be in the cart. The following items were not present as required by the policy: - Dextrose 50%, 50 ml IV; - Benadryl 50mg/ml IM, IV; - 0.9 Sodium Chloride IV 1000 mL; - Zoll pads (AED pads); - Radio Battery; - Flashlight with spare batteries and - IV administration set The surveyor asked Staff Member #1 if the facility had an oxygen tank available and if there were additional AED electrode pads available for use. Staff Member #1 confirmed there was no oxygen tank in the facility and there were no additional AED electrode pads available.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to develop and maintain an emergency preparedness training and testing program specific to the facility’s needs. Findings: The facility’s policy titled, “Emergency Preparedness”, states in part: “... 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: ... Train all dialysis employees... Comply with federal, state, and local laws and regulations...”. The facility’s policy titled, “Emergency and Disaster Responsibility”, states in part: “... I. Roles of Director or Operations / Area Manager... Responsible for all the disaster planning and response... Join local emergency healthcare coalitions and schedule to participate in any full-scale community based disaster drills. Conduct a table top drill. Document drills. Medical Director: ... Participate in facility Table Top Drill and Community Based disaster drill annually...”. A facility policy titled, “Competency Assessment Program Exams” states in part: “... The Competency Assessment program will help the facility to maintain high standards of quality patient care through the assessment of clinical and theoretical knowledge of patient care staff using the facility’s personnel assessment survey, facility needs and orientation competency checklists... 1. The facility will be assessed... on a yearly basis... 3. After the education program is given, evaluation of performance will determine the need for further instruction... 4. Documentation of staff’s progress will occur using... annual competency exams...”. A facility document titled, “Orientation/Skills Checklist”, was reviewed. The document has a “Content” column which has various topics listed. Of the topics the following were included: “Emergency Equipment/Procedure”. The surveyor reviewed the facility’s emergency preparedness program binder, the binder contained documentation of a power failure “drill” on 12/01/2023. The surveyor was unable to determine if the “drill” was a functional exercise or a mock disaster drill. The documentation did not contain an analysis of the facility’s response. The surveyor asked Staff Member #1 for any additional documentation of drills and/or exercises the facility has conducted. The surveyor was provided with two documents both titled, “Emergency Preparedness Documentation of Emergency Exercises.” The following information was revealed: Document #1 indicated a tabletop or workshop exercise was conducted on 04/20/2023. The scenario was “Floods/Power Failure” and the description was “Facility lost power due to snow storm.” The document listed the problem statement, the after exercise review/lesson learned and that the exercise addressed an issue that had been identified in the facility’s risk assessment (which had not been conducted). Document #2 indicated a tabletop or workshop exercise was conducted on 03/20/2024. The scenario was “Power Failure” and the description was “Facility lost power due to snow storm”. The documentation for the list of problem statement and the after exercise review/lessons learned read exactly the same as the exercise conducted on 04/20/2023. The document listed the names of three (3) staff members who participated in the exercise. The surveyor confirmed that one of the staff members listed on the document did not participate in the exercise. On 04/23/2024, the surveyor reviewed the personnel records for four (4) staff members. The surveyor was unable to locate emergency preparedness training documentation for Staff Members #2, #7, #8 and #9. The surveyor asked Staff Member #1 about the missing documentation, Staff Member #1 replied, “that is all that was in the file.” The surveyor asked Staff Member #8 about the receipt of emergency preparedness training, Staff Member #8 said, “we have a meeting in July or August where we talk about that.” The surveyor asked Staff Member #1 for any documentation available to support the meeting or training. No additional documentation was provided to the surveyor prior to the exit conference.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 36946 Based on observation and document review, it was determined the facility failed to ensure it provided a sanitary environment. Specifically, the facility utilized the restroom for storage of dialysate fluid. Additionally, the facility did not have bathrooms designated specifically for patient and staff use. Findings: On 04/23/24 the surveyor asked Staff Member #6 for the location of the restroom. The restroom was not specifically marked for patient or staff use. The restroom in the facility was observed to have multiple boxes of sterile dialysate fluid in storage stacked on top of each other. Cardboard boxes containing dialysate fluid were directly on the floor without being elevated off the floor to prevent contamination. The boxes of fluid were stored in close proximity to the toilet, trashcan, and sink without room to prevent them from becoming contaminated. The facility’s policy, “Infection Control Practices and Procedures for Dialysis Facilities and Treatments Performed in the Home” state in part: “Additional measures to prevent contamination of clean or sterile items include: Not handling or storing contaminated supplies, equipment, blood samples, or biohazard containers in area where medications and clean (i.e. unused( equipment and supplies are handled)...Bathroom facilities: Dialysis patients should utilize the patient bathroom specifically marked for patient use...All personnel should only utilize the staff bathrooms.””

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 42725 Based on interview and document review, it was determined the facility failed to provide infection control training to three (3) of the four (4) staff members reviewed. Findings: A facility policy titled, “Competency Assessment Program Exams” states in part: “... The Competency Assessment program will help the facility to maintain high standards of quality patient care through the assessment of clinical and theoretical knowledge of patient care staff using the facility’s personnel assessment survey, facility needs and orientation competency checklists... 1. The facility will be assessed... on a yearly basis... 3. After the education program is given, evaluation of performance will determine the need for further instruction... 4. Documentation of staff’s progress will occur using... annual competency exams...” A facility document titled, “Orientation/Skills Checklist”, was reviewed. The document has a “Content” column which has various topics listed. Of the topics the following were included: “Hand Hygiene”, “Infection Monitoring”, “Aseptic Technique” and “Infection Management”. On 04/23/2024, a review was conducted of four (4) Staff Members (#2, #7, #8 and #9) personnel files. There was no documentation in the files that the Staff Members #2, #8 and #9 had received infection control training. There were no “orientation/skills checklist” located in the three (3) files. The surveyor inquired if there were any annual online or in person training required for infection control, Staff Member #8 said, “they will randomly watch what we are doing sometimes”. The surveyor was unable to locate evidence that the facility has an annual infection control training program. The surveyor asked Staff Member #1 about the missing documentation, Staff Member #1 replied, “that is all that was in the file.””

“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: 40084 Based on staff interview and document review, it was determined the facility failed to develop and update each home patient’s plan of care according to the facility’s policies and procedures in one (1) of three (3) records reviewed in the survey sample. Medical record for Patient #2. Findings: Review of the medical record for Patient #2 evidenced the patient initiated home peritoneal dialysis with the facility on 12/27/22. An initial care plan was completed by the interdisciplinary team on 01/27/23. This initial care plan contained some documentation from the social worker, but the care plan was not signed by the social worker and the documentation was marked “incomplete” in the medical record. The team met again to complete an additional care plan and comprehensive assessment on 04/27/23, but the plan of care failed to contain evidence of any input from the social worker or a social worker assessment. The medical record for Patient #2 contained no evidence that the social worker has participated in any comprehensive care planning for the patient since admission to the facility sixteen (16) months ago. The facility’s policy, “Interdisciplinary Team Patient Assessments” states in part: “An initial assessment will be done for all patients and completed by all disciplines within the latter of thirty (30) calendar days or thirteen (13) outpatient sessions beginning with the first outpatient session. A comprehensive reassessment will occur within three months after the completion of the initial assessment to provide information to adjust the patient;s plan of care...Patient reassessment - At least annually for stable patients. “ An interview was conducted with Staff Member #6 on 04/23/24 during record review. Staff member #6 stated the social worker should have completed the assessment from the first care plan and participated in the second care plan occurring at 90 days for the patient. Staff member #6 confirmed the incomplete social worker initial assessment and the absence of a 90 day re-assessment in the medical record for Patient #2.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to demonstrate and document an effective QAPI program. Findings: A facility policy titled, “Continuous Quality Assessment and Performance Improvement Plan (CQAPI)”, states in part: “The Facility will develop, implement, maintain, and evaluate an effective, data driven, quality improvement program. The program will focus on indicators related to improved health outcomes and the prevention and reduction of medical errors... The program will serve to reveal opportunities, to improve care, and to resolve identified problems and improve trends to meet specific standards... C. The facility will compare their specific data to network or national data to assess, identify, analyze, correct, and monitor real or potential problems and/or trends. D. The Facility Committee meets at least monthly/quarterly (facility specific) under the supervision of the Facility GB... F. Minutes are recorded at each meeting. G. The scope of the CQAPI program includes monitoring of clinical performance measures as well as patient satisfaction, patient quality of life (Facility Specific) and other quality indicators as per the CQAPI Indicators as developed by the facility. 1. The CQAPI program will also include risk management activities for infection control,... staff competency and performance issues, as appropriate. 2. The CQAPI Indicators will be utilized as the basis for the monthly facility CQAPI meetings. 3. The CQAPI process, including an action plan, should be utilized for each improvement opportunity identified... Reporting and Confidentiality A. Minutes of the committee meeting shall be recorded and reported by each Facility and reported to the Governing Body. B. Indicator monitoring results, actions taken, and follow-up monitoring will be fully documented. The documentation of all CQAPI activities will be updated on an ongoing basis and will reflect current status of each identified problem. On a monthly/quarterly basis, a summary of all CQAPI activities will be reported to the Governing Body... 5. Program Evaluation A. Facility will evaluate the CQAPI Program at least annually to assure that it meets the continuous quality improvement needs and goals of the facility. B. The facility will set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety...”. The surveyor conducted a review of the QAPI program. The “QAPI summary” from September 2023 to February 2024 were reviewed. There was no documentation available for March 2024. The surveyor inquired if a March QAPI meeting was held, Staff Member #1 replied, “we did not have one”. The surveyor reviewed the “Peritoneal Dialysis CAPD and CCPD Dimension Report Card” for the meeting that was held on 02/19/2024. The timeframe of the report card was “Feb 23 through Jan 24”. The facility had not consistently met any of the eight (8) goals listed on the report card. An interview was conducted with Staff Member #3 on 04/23/2024 via telephone. Staff Member #3 is involved with the QAPI program. The quality focus, according to Staff Member #3, is the patient’s home medications. Specifically, “knowing all the home medications they are taking, I would like for them to be at 90% accuracy”. Staff Member #3 said that the IDT discusses every patient monthly, “it is a continuous assessment”. The surveyor could not locate any documentation via the QAPI program that this was a quality focus area. An interview was conducted with Staff Member #5 on 04/23/2024 via telephone. Staff Member #5 advised the surveyor of the data they are responsible for reporting on for QAPI. Staff Member #5 said that the IDT “discuss the patients monthly”. Staff Member #5 said, “we meet in the PD room” (referring to the PD room at the provider’s office). An interview was conducted with Staff Member #4 on 04/23/2024 via telephone. Staff Member #4 informed the surveyor of what data they are responsible for at QAPI. With regard to a QAPI meeting, Staff Member #4 said, ‘we meet but I can’t say we sit and have a formal discussion”. Staff Member #2 was interviewed via telephone on 04/23/2024. Staff Member #2 explained what they are responsible for reporting on for QAPI. The surveyor inquired if the facility held a formal QAPI meeting monthly, Staff Member #2 replied, “we discuss all the patients monthly”. The surveyor located no formal “meeting minutes” to support the interdisciplinary team reviewed, analyzed and discussed all areas of QAPI. There was no documentation to support the facility is identifying, reporting, tracking near misses, errors and adverse events or monitoring patient satisfaction and tracking patient grievances.”

“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: 40084 Based on interview and record review, it was determined the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to take action to ensure sustained improvement over time. Specifically, the QAPI program failed to correct known issues related to Emergency Preparedness and Patient Plan of Care. The findings include: Current Recertification Survey Tag E-0004 Based on interview and document review, it was determined the facility failed to develop and implement an emergency preparedness plan that contains all the required elements. Recertification Survey Ending May 5, 2021 Tags E-0024 and E-0026 Based on document review and interview, it was determined the facility did not have an emergency preparedness policy and procedure related to the use of volunteers during an emergency. Based on interview and document review, it was determined the facility failed to have a policy and procedure outlining the role of the facility under an 1135 waiver. Current Recertification Survey Tag V-0556 Based on staff interview and document review, it was determined the facility failed to develop and update each home patient’s plan of care according to the facility’s policies and procedures in one (1) of three (3) records reviewed in the survey sample. Medical record for Patient #2. Tag V-0556 Recertification Survey Ending May 5, 2021 Based on document review and interview, it was determined the interdisciplinary team (IDT) and the patient failed to sign the plan of care (POC) for patient #1.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined that the facility failed to conduct annual competency assessments for three (3) of four (4) personnel records reviewed. (Staff Members #2, #8 and #9) Findings: A facility policy titled, “Competency Assessment Program Exams”, states in part: “... The Competency Assessment program will help the facility to maintain high standards of quality patient care through the assessment of clinical and theoretical knowledge of patient care staff using the facility’s personnel assessment survey, facility needs and orientation competency checklists... 1. The facility will be assessed... on a yearly basis... 3. After the education program is given, evaluation of performance will determine the need for further instruction... 4. Documentation of staff’s progress will occur using... annual competency exams...”. A facility document titled, Orientation/Skills Checklist, was reviewed. The document has a “Content” column which has various topics listed. On 04/23/2024, a review was conducted of four (4) Staff Members (#2, #7, #8 and #9) personnel files. There were no “orientation/skills checklist” located in the three (3) files (Staff Members #2, #8 and #9). Staff Member #1 confirmed that the “orientation/skills checklist” is the document used for competency assessment. The surveyor asked Staff Member #1 about the missing documentation, Staff Member #1 replied, “that is all that was in the file.””