Nephron-Norcross Dialysis Center

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 03383 Based on a review of Quality Assessment and Performance Improvement (QAPI) meeting minutes and staff interviews, it was determined that the Interdisciplinary Team (IDT) failed to develop and implement an effective QAPI program that monitored indicators related to the patient outcomes and safety. This failure had the potential to negatively impact the health and safety of 27 patients who were under the care of this facility. Findings include: Cross References: V 626 - Failure of the facility to ensure that the IDT conducted monthly QAPI meetings to adequately monitor, discuss, and develop a plan to ensure that improvements were made and sustained on indicators related to improved health outcomes. V 627 - Failure of the facility to monitor indicators or performance measures that included water and dialysate quality safety and safe machine maintenance. V 634 - Failure of the IDT to compile and review reports related to patient adverse occurences. V 636 - Failure of the IDT to monitor and tract patient satisfaction surveys, grievance reports, and outcomes. V 638 - Failure of the IDT to track, trend, analyze, and develop plans of action to improve and sustain outcomes.”

“CFC-PERSONNEL QUALIFICATIONS CFR(s): 494.140 This Condition is not met as evidenced by: 03383 Based on a review of facility records and staff interviews, it was determined that the facility failed to ensure that the facility had a qualified social worker (SW) to meet the psychosocial needs of the patients. This failure could negatively affect the health and safety of 27 patients who were under the care of this facility. Findings were: Cross reference: V 691 - Failure of the facility to provide social services by a qualified SW, to meet the patients’ psychosocial needs.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 03383 Based on a review of facility records and staff interview, it was determined that the Medical Director (MD) failed to demonstrate accountability for the clinical operations of the facility to ensure the delivery of safe patient care. This failure had the potential to negatively affect the health and safety of 27 patients who were dialyzing at this facility. Findings include: Cross References: V 516 - Failure of the Medical Director to ensure the IDT completed an initial comprehensive assessment on a new patient (P#1) within 30 calendar days or 13 hemodialysis sessions, that addressed his specific needs for psychosocial services by a qualified social worker. V 712 - Failure of the MD to demonstrate operational responsibility for the facility’s Quality Assessment and Performance Improvement program for six of six months (September 2023 - February 2024) meeting minutes reviewed. V 715 - Failure of the MD to ensure that all Direct Patient Care Staff adhered to facility policy and procedures pertaining to hypertension [elevated blood pressure (BP)] to ensure that two of two patients (P#2 and P#3) sampled, who experienced high BP readings during dialysis treatment, received medical care and supervision appropriate to patient’s dialysis needs.”

“EP Program Patient Population CFR(s): §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(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:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[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 all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure the facility’s Emergency Preparedness Plan (EPP) addressed patient population, including, but not limited to, persons at-risk; the type of services the facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. The facility census was 27. Findings were A review of the facility’s EPP with the Nurse Practitioner (NP) on 4/10/24 at 1:53 p.m., revealed a lack of system in place for medical documentation that preserved patient information, protected confidentiality of patient information, and secured and maintained availability of records. The NP confirmed the above findings on 4/10/24 at 1:53 p.m.”

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed develop a system to track all patients and staff in the facility’s care during an emergency event. The facility census was 27. Findings were: A review of the facility’s EPP with the Nurse Practitioner (NP) on 4/10/24 at 1:53 p.m., revealed a lack of system in place to track the location of on-duty staff and sheltered patients in the facility’s care during an emergency; and what to do if on-duty staff and sheltered patients are relocated during the emergency. The NP was present and assisted this surveyor to look for the above information in the EPP binder 4/10/24 at 1:53 p.m., and did not produce the missing document.”

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure the facility’s Emergency Preparedness Plan (EPP) included a policy and procedure to show the EPP included a system for medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. Findings were: A review of the facility’s EPP with the Nurse Practitioner (NP) on 4/10/24 at 1:53 p.m. revealed a lack of system in place for medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintaineds availability of records. The NP confirmed the above findings on 4/10/24 at 1:53 p.m.”

“Information on Occupancy/Needs CFR(s): §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure that the communication plan in the Emergency Preparedness Plan (EPP) included a means of providing information about the facility’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. The facility census was 27. Findings were: A review of the facility’s EPP with the Nurse Practitioner (NP) on 4/10/24 at 1:53 p.m. revealed the communication plan lacked a means of providing information about the facility’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. The NP confirmed the above findings on 4/10/24 at 1:53 p.m.”

“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: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure the facility’s Emergency Preparedness Plan (EPP) included testing of the information provided during orientation and training of patients and staff based on the risk assessment and communication plan of the EPP, and the training, testing and orientation program was evaluated and updated every two years. The facility census was 27. Findings were: A review of the facility’s EPP with the Nurse Practitioner (NP) on 4/10/24 at 1:53 p.m. revealed the EPP lacked testing of the information provided during orientation and training of patients and staff. The NP confirmed the above findings on 4/10/24 at 1:53 p.m. and did not produce the missing document.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure the facility’s Emergency Preparedness Plan (EPP) included testing requirements which included conducting exercises to test the emergency plan annually that included staff and patient participatation in a full-scale exercise that is community-based every two years; conduct an additional exercise at least every two years, opposite the year the full-scale or functional exercise, along with an analysis of the facility’s response of the exercise and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the facility’s emergency plan, as needed. The facility census was 27. Findings were: A review of the facility’s EPP with the Nurse Practitioner (NP) on 04/10/24 at 1:53 p.m. revealed the facility has not conducted a mock disaster drill; a full-scale exercise that is community-based, or a tabletop exercise or workshop at least every two years. The NP confirmed the above findings on 4/10/24 at 1:53 p.m. and did not produce the missing documents.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 03383 Based on observation, a review of Centers for Disease Control (CDC) recommendations and facility policy, and staff interviews, it was determined that the Infection Control Committee failed to ensure that one of one physician (Dr. AA) observed, performed hand hygiene between each patient and/or station; and disinfected stethoscope between patient uses. This deficient practice had the potential for cross contamination and increased risk of infection for seven of seven patients [Patients who were seated at Stations (S) 2, 3, 5, 6, 9, 11, and 13] and could negatively affect the health and safety of the other 20 in-center hemodialysis patients who were dialyzing at this facility. Findings were: During observation in the Patient Treatment Room on 4/9/24 between 7:42 a.m. and 8:30 a.m., the following was observed: - There were 7 patients who were receiving dialysis treatment during this observation. - On 4/9/24 beginning at 8:19 a.m., Dr. AA moved from patient to patient, and from one station to another. Dr. AA touched patients, the machine keyboards and panels with ungloved hands. Dr. AA did not perform hand hygiene after touching each patient and their machines at S5, S6, and S9. - Dr. AA did not wash hands with soap and water until he examined a patient, who was seated at S11 but then, went on to patients who were seated at S2, S3, and S13. Dr. AA touched patients and their keyboard/computer screen without performing hand hygiene between each patient and station. - In addition, Dr. AA listened to patients’ lung sounds and did not clean or disinfect stethoscope between patient uses. - Dr. AA did not clean his stethoscope, even after leaving the treatment area. A review of undated policy titled, “Universal Precautions” stated: Hand washing must be done when arriving and leaving the unit and between patients. Dr. AA and the Nurse Practitioner were informed about the above observations during exit conference on 4/10/24 at 3:30 p.m. Dr. AA questioned the cleaning of stethoscope between patients when others in different settings such as hospitals and clinics, do not do it.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the facility failed to ensure that there was a safe environment for all patients and staff, as evidenced by failure of the facility to ensure that one of one double doors in the Storage Room, was maintained to prevent entry of insects and vermin. The facility also failed to maintain the floor clean and dry in one of one Water Treatment Room, that had the potential for slips and fall accidents for three of three staff, who were working at the time of this observation and whose job involved trips to the Water Treatment Room. The facility census was 27. Findings were: 1. During a tour of the facility with the Charge Nurse on 4/8/24 at 2:28 p.m., the following was observed: The double doors in the Storage Room that led to the outside had approximately 1/4 inch - 1/2 inch gap on the right side of the double doors and the floor (12 inches across the right door) that could allow insects and vermin to enter the building. 2. During observation in the Water Treatment Room with PCT AA on 4/9/24 at 5:43 a.m., the following was revealed: The RO (Reverse Osmosis - a water treatment process that removes contaminants from water) storage tank had water overflowing from the top of the tank that spilled onto the floor. Standing water was observed on the floor in the Water Treatment Room around the two carbon tanks (used to remove chlorine and chloramines from the water), brine tank (part of the water softener system, which removes minerals such as calcium and magnesium), and around the cart that stored chlorine test strips used for testing the water. The Medical Director was notified of the above findings on 4/9/24 at 8:08 a.m., and did not offer additional information. A re-inspection of the back exit doors on 4/10/24 at 1:30 p.m., showed unrepaired gap between the double doors and the floor.”

“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: 03383 Based on observation and staff interview, it was determined that the facility failed to maintain a clean, orderly, and safe environment. These environmental concerns were observed in one of one office area, one of one storage area, and one of one Biomed area. This deficient practice could negatively affect the health and safety of all staff and 27 patients who were receiving dialysis treatment at this facility. Findings were: During a tour with the Charge Nurse (CN) on 4/8/24 at 2:28 p.m., the following was observed: - Multiple items were cluttered against the wall next to an exit door in the office area from recent renovation of the facility. Items included four wall panels, five boxes of various sizes, a rolling chest cooler, and a square metal object. - The storage area had debris on the floor under the clean items that were stored on the shelves. - The computer/Biomed area had a broken down dialysis machine and two dirty mop buckets with a mop in one of the buckets. - There were soiled tiles in front of the double doors in the storage area along with cement debris. - There was a large wall panel that leaned against clean acid jugs; and a trash can with cleaning supplies draped around it that leaned against the water heaters and Granuflo boxes. The CN confirmed the above findings on 4/8/24 at 2:30 p.m. The CN stated that the facility was renovated and has not been cleaned; some items had not been returned to hang on the wall; and some items had not been disposed of.”

“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: 03383 Based on observation and staff interview, it was determined that the facility failed to maintain a safe environment as evidenced by torn leather upholstery on three of 13 patient treatment chairs. This deficient practice could hinder effective cleaning/disinfection and could have a negative effect on the health and safety of 27 patients who were receiving dialysis treatment at this facility. Findings were: During a tour of the treatment area on 4/8/24 at 2:28 p.m., the following was observed: - The patient treatment chairs in Stations (S) 4 and 13 had cracks and tears in the arm of the chair. - The treatment chair in S1 had a one inch crack in the back rest of the chair. The Charge Nurse was present during the tour and confirmed the above findings on 4/8/24 at 2:30 p.m.”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 03383 Based on a review of facility records and staff interviews, it was determined that the facility failed to ensure that initial comprehensive assessment was completed by the entire Interdisciplinary Team (IDT) for one of one patient (P#1), who was sampled for new admission. This deficient practice had the potential to negatively affect 27 patients who were dialyzing at this facility. Findings include: A review of P#1’s medical records revealed the following: - P#1 was admitted to this facility on 2/12/24. - A review of P#1’s Initial Interdisciplinary Comprehensive Assessment (CIPA) and Plan of Care (POC) dated 3/4/24, showed a lack of psychosocial assessment that was conducted by a qualified social worker (SW). During an interview with the Patient Coordinator (PC) on 4/10/24 at 8:56 a.m., she stated that she does not have a degree in social work but has been performing SW duties such as completing the KDQOL-36 (Kidney Disease Quality of Life 36-item survey: a patient-reported outcome measure for patients on dialysis) and PHQ-9 (a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression). An interview with Staff XX on 4/10/24 at 10:00 a.m. revealed that a SW has not come to this facility since November of 2023. During the exit interview on 4/10/24 at 3:30 p.m., the Medical Director and the Nurse Practitioner (NP) were informed of the above findings and concerns with lack of a qualified SW at this facility, to meet the needs of patients. The Medical Director and NP indicated that P#1 had been in and out of the hospital.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 03383 Based on a review of records and staff interview, it was determined that the facility failed to ensure that one of one patient (P#1) who was sampled for new admission, had an Initial Comprehensive Interdisciplinary Assessment that was conducted within 30 calendar days or 13 hemodialysis sessions, that addressed his specific needs for psychosocial services by a qualified social worker (SW). This deficient practice had the potential to negatively affect all newly admitted patients under the care of this facility. The facility census was 27. Findings include: A review of medical records revealed the following: - P#1 was admitted to this facility on 2/12/24. - A review of P#1’s Initial Interdisciplinary Comprehensive Assessment (CIPA) and Plan of Care (POC) dated 3/4/24, showed the following: 1. The section that asked if patient understands and accepts kidney disease and treatment was left blank. 2. The transplant section was not addressed and was left blank. 3. There was a lack of documented psychosocial assessment that included psychological needs, financial, social resources, and stability of patient. During the exit interview on 4/10/24 at 3:30 p.m., the Medical Director and the Nurse Practitioner (NP) were informed of the above findings and concerns with a lack of qualified SW at this facility. The Medical Director and NP indicated that the patient had been in and out of the hospital.”

“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: 03383 Based on a review of the Dialysis Facility Report (DFR: A report prepared for Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), review of records, and staff interview, it was determined that the facility failed to ensure that the interdisciplinary team (IDT) conducted monthly Quality Assessment and Performance Improvement (QAPI) meetings for six of six months (September 2023 - February 2024), to adequately monitor, discuss, and develop plans of action to ensure that improvements were made and sustained on indicators related to improved health outcomes. This deficient practice could negatively affect the health and safety of 27 patients who were dialyzing at this facility. Findings were: A review of the 2024 DFR showed the following: - Infection: The percentage of Medicare dialysis patients at this facility hospitalized with septicemia during 2019-2022 was 14% compared to 13% in Georgia (GA), 11% in Network 06 (included GA), and 12% nationally. - Transplant Waitlist: The 2022 age-adjusted percent waitlisted at this facility was 1.5%, which was 15% lower than the national adjusted percentage. - Dialysis Adequacy: In 2022, 65% of patients had a Kt/V (a number used to quantify hemodialysis adequacy) >= (greater or equal to) 1.2 reported, compared to 95% in GA, 96% in Network 06, and 96% nationally. - Vascular Access: This facility’s 2022 Standardized Fistula Rate (SFR) for prevalent patients was 45%, which was 14% lower than the national SFR. Of the prevalent patients receiving hemodialysis treatment at this facility in 2022, the long term catheter rate was 28%, compared to 15% in GA, 15% in Network 06, and 17% nationally. A written request for QAPI team meeting minutes for past six months (September 2023-February 2024) and any supporting materials was given to the Nurse Practitioner (NP) on 4/8/24 at approximately 11:00 a.m. The only QAPI meeting minutes presented to this surveyor by the NP was from the QAPI meeting held on 1/22/24. There was no documentary evidence that the IDT held QAPI meetings in September, October, November, December of 2023, and February 2024. A review of facility QAPI records dated 1/22/24 revealed a lack of an effective, data-driven, quality assessment and performance improvement program. The facility failed to produce monthly QAPI meeting minutes that demonstrated activities which positively influenced patient outcomes. For example, a review of the only QAPI meeting minutes available for review, showed the following: Date of Meeting: 1/22/2024 Team Members: Medical Director/Provider, Clinical Nurse Manager, Social Worker, Dietitian, Bio Med Technician, and Facility Administrator. [All team members signed the QAPI form except the Medical Director and Biomed Technician (form showed “Not Present”]. Adequacy: Problem Statement: 56% patients have meet (sic) goal Goal: Greater than 95% will meet goal Root Cause Analysis: Lab results are not timely Action Plan/Plan of Correction: Continue to collect all labs when needed Responsible IDT Team Member(s): Charge RN Start Date: 1/22/24 Check Point: 2/22/24 End Date: 3/22/24 Status, Outcomes, and Evaluation: All patients will have Kt/V greater than 1.2 Access Management: Problem Statement: To (sic) many catheters Goal: Pt (Patient) will have cathaters (sic) Root Cause Analysis: No viable access or bad vein Action Plan/Plan of Correction: Increase fistula rate more patients with grafter (sic) fistula Responsible IDT Team Member(s): Charge RN, Social Worker, Medical Director Start Date: 1/22/24 Check Point: 2/22/24 End Date: 3/22/24 Status, Outcomes, and Evaluation: Patience (sic) will have less catheters Action Plan/Plan of Correction: Patients will have less catheters Responsible IDT Team Member(s): Charge RN, Medical Director, Facility Administrator Start Date: 1/22/24 Check Point: 2/22/24 End Date: 3/22/24 Status, Outcomes, and Evaluation: Patient 1 (sic) have less catheters Action Plan/Plan of Correction: Patients have less catheters Responsible IDT Team Member(s): Charge RN, Medical Director, Facility Administrator Start Date: 1/22/24 Check Point: 2/22/24 End Date: 3/22/24 Status, Outcomes, and Evaluation: Left blank. The other performance measures documented in 1/22/24 QAPI meeting were: Calcium and Phosphorus, Anemia, Safety-Fluids, Mortality, Access Infection, Albumin, Hospital readmits < 30 days, and Missed Treatments. There was a lack of documented plans of action, implementation and evaluation of action plans to improve and sustain clinical outcomes. During an interview on 4/10/24 at 10:40 a.m., Staff XX stated, “There has been no QAPI meetings at this clinic since the social worker (SW) quit in October 2023. The Patient Coordinator (PC) came here to cover and worked under a SW who was assigned to other clinics; that SW did not come here”.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 03383 Based on a review of Quality Assessment and Performance Improvement (QAPI) meeting minutes and staff interview, it was determined that the interdisciplinary team (IDT) failed to monitor indicators or performance measures that included water and dialysate quality safety and safe machine maintenance in six of six months (September 2023 - February 2024) QAPI meeting minutes requested/reviewed. This deficient practice had the potential to negatively affect the health and safety of 27 patients who were dialyzing at this facility. Findings were: A written request for QAPI team meeting minutes for past six months (September 2023 - February 2024) and any supporting materials was given to the Nurse Practitioner (NP) on 4/8/24 at approximately 11:00 a.m. The only QAPI meeting minutes presented to this surveyor by the NP was from the meeting held on 1/22/24. The Biomed Technician (BT) was not in attendance and there was a lack of documented evidence that water and dialysate quality and machine maintenance were included in QAPI. During an interview on 4/9/24 at 10:13 p.m., the BT stated he attends QAPI meetings. However, there was no documentary evidence that the IDT held QAPI meetings in September, October, November, December of 2023, and February 2024.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 03383 Based on a review of Quality Assessment and Performance Improvement (QAPI) meeting minutes, it was determined that the QAPI team failed to compile and review reports related to patient adverse occurences for six of six months (September 2023 - February 2024) meeting minutes requested/reviewed. This deficient practice had the potential to negatively affect the health and safety of 27 patients who were dialyzing at this facility. Findings were: A written request for QAPI team meeting minutes for past six months (September 2023 - February 2024) and any supporting materials was given to the Nurse Practitioner (NP) on 4/8/24 at approximately 11:00 a.m. The only QAPI meeting minutes presented to this surveyor by the NP was from the meeting held on 1/22/24. A review of the minutes showed a lack of documentary evidence that adverse occurrences/near misses were addressed in QAPI.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 03383 Based on a review of Quality Assessment and Performance Improvement (QAPI) meeting minutes and staff interviews, it was determined that the QAPI team failed to monitor and tract patient grievance reports and outcomes; and to include patient satisfaction surveys in QAPI as a means to identify opportunities to improve care. The facility census was 27. Findings were: The only QAPI meeting minutes presented to this surveyor by the NP, was for the meeting held on 1/22/24. A review of the minutes showed that patient satisfaction surveys and patient grievances were not included in QAPI. Cross Reference: V 765 - Failure of the facility to implement internal grievance process.”

“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: 03383 Based on a review of the Quarterly Update of the Fiscal Year 2024 Dialysis Facility Report (DFR: A report prepared for the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), a review of facility records, and staff interviews, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track, trend, analyze, and develop plans of action to improve and sustain the facility’s long term catheter rate and dialysis adequacy. This deficient practice had the potential to negatively affect the health and safety of 27 patients who were dialyzing at this facility. A review of the Quarterly Update of the Fiscal Year 2024 DFR for this facility, showed the following: Long Term Catheter Rate: The Long Term Catheter Rate for Q1 (Quarter 1): January-March 2023 was 32.5; and had increased to 39.4 in Q2: April-June 2023, compared to 15.3 in Georgia (GA), 14.4 in Network 06 (included GA), and 17.2 nationally. Dialysis Adequacy (Goal: Kt/V (a number used to quantify hemodialysis adequacy) >= 1.2): The Kt/V < (less than) 1.2 for Q1: January-March 2023 was 3.8%; and had increased to 5.4% in Q2: April-June 2023 for this facility, compared to 2.4% in GA, 2.2% in Network 06, and 1.9% in U.S. In comparison, this facility’s adequacy outcome for last six months (September 2023 - February 2024) did not improve and the percentage of patients whose Kt/V was <1.2 had increased based on a review of the following laboratory results for this facility: - In September 2023, 17% of the patients had a Kt/V < 1.2; - In October 2023 - 10%; - In November 2023 - 19%; - In December 2023 - 22%; - In January 2024 - 17%; and - In February 2024 - 17%. There was no documentary evidence that the IDT held QAPI meetings in September, October, November, December of 2023, and February 2024. A review of the only QAPI meeting minutes (dated 1/22/24) available, revealed a lack of documentary evidence that the QAPI team developed plans of action and tracked performance to ensure that improvements were attained and sustained over time. During an interview on 4/10/24 at 10:40 a.m., Staff XX stated, “There has been no QAPI meetings at this clinic since the social worker (SW) quit in October 2023”.”

“PQ-SW-MSW;GRANDFATHER IF HIRED BEFORE 1976 CFR(s): 494.140(d) The facility must have a social worker who- (1) Holds a master’s degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education; or (2) Has served at least 2 years as a social worker, 1 year of which was in a dialysis unit or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who qualifies under §494.140 (d)(1). This Standard is not met as evidenced by: 03383 Based on a review of records and staff interviews, it was determined that the facility failed to provide social services by a qualified social worker (SW), to meet the patients’ psychosocial needs; perform assessments, develop psychosocial plans of care, and provide counseling to patients and families. This failure could negatively affect the health and safety of 27 patients who were under the care of this facility. Findings were: A review of the Patient Notes under “Note Type” Progress Notes - SW, from 2/1/24 - 4/9/24 showed the following: For P#1: - The Patient Coordinator (PC) documented under SW Progress Notes on 2/21/24, 2/26/24, 3/4/24, 3/11/24, 03/18/24, 3/27/24, 4/3/24, and on 4/8/24. - On 3/11/24, it was documented that PC tried to do KDQOL (Kidney Disease Quality of Life 36-item survey: A patient-reported outcome measure for patients on dialysis) and PH2 (sic) (PHQ-9: A multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression) and CAREPLAN (sic)... - On 3/20/24, PC documented “... since first treatment he alwas (sic) cut his treatment short, and gets in a bad mood if his treatment doesnt (sic) run on his own way, and has really moody with staff...” - On 4/3/24, PC documented “Pt (Patient) states (sic) is not good, she has to (sic) much stress and responsibilities on taking care her husband at the Hospital... I tried to do CarePlan and didnt (sic) work out well, she told me try next time.” - There was a lack of documented participation/involvement of a qualified Licensed Master Social Worker (LMSW). For P#2: - PC documented under SW Progress Notes on 2/21/24, 2/26/24, 3/4/24, 3/11/24, 3/18/24, 3/27/24, 4/3/24, and on 4/8/24. For P#3: - PC documented under SW Progress Notes on 2/21/24, 2/26/24, 3/4/24, 3/11/24, 3/18/24, 3/27/24, 4/3/24, and on 4/8/24. For P#4: - PC documented under SW Progress Notes on 2/21/24, 2/27/24, 3/5/24, 3/12/24, 3/19/24, 3/30/24, 3/26/24, 4/2/24, and on 4/9/24. For P#5: - PC documented under SW Progress Notes on 2/21/24, 2/26/24, 3/4/24, 3/11/24, 03/18/24, 3/27/24, 4/3/24, and on 4/8/24. The last SW Notes that were completed by a Licensed Master Social Worker (LMSW) AA, who left this facility in August of 2023 was on 8/9/23 for P#2; on 8/18/23 for P#5; on 8/3/23 for P#3; and on 8/22/23 for P#4. SW Progress Notes dated 10/21/23 showed LMSW BB spoke to P#4 about transplant concerns. No further documentation was found or provided that showed LMSW BB’s involvement/participation in the care of the remaining four patients (P#1, P#2, P#3, and P#5). Moreover, Patient KDQOL36 Survey results for P#2 showed under SW Conclusion: “Patient continues to adjust to being on dyalisis (sic). However pt (patient) mark (sic) some areas of concern on her (sic) most recent KDQOL regarding of (sic) his feelings, frustations (sic) and depresions (sic) dealing with her (sic) kidney disease. SW will follow-up with patient regarding his mental health state to see if he currently hasa (sic) counselor that he speaks with on a regular basis and if so that he may need to increase sessions with his counselor when he feeling down. If pt doesnt (sic) currently have a conseour (sic), sw will speak with pt about getting starrted (sic) with one or will make a referral for a patient mental health counseling. Due to his score of 6 on PHQ2 screen and PHQ9 scored 19.” This SW conclusion was documented and signed off by PC on 12/29/23. There was a lack of documented involvement and follow-up by the LMSW. A review of the undated facility “Social Workers’ Role and Responsibilities” revealed the following: Essential Functions: - Meet with and check in with patient and their family on a weekly basis to provide psychosocial support needed to cope with chronic, acute, or terminal illnesses. - Provide care and case management, or interventions designed to promote health, prevent disease, and address barriers to access healthcare. - Conduct psychosocial assessments on each patient and determine social work treatment plan compatible with a total medical treatment plan per CMS guidelines (initial, 90-day, annual and adjusted treatment plans in compliance with status changes in the status of an unstable patient. - Complete KDQOL, PHQ9/2 and other assessment tools as required. - Complete quarterly reviews and provide quarterly documentation in every patient’s charts. - Review grievances and assist in the resolution of the grievance as well as report to the facility administrator. - Complete monthly tracking of patients needed for QAPI and actively participate in activities that elevate clinical outcomes throughout the QAPI process. - Provide supportive and goal directed counseling to patients who are seeking transplant. - Assess patient awareness of advanced directives; assists with accessing advanced directive wishes ...” - Documents reviewed do not show a SW has completed the items listed under Social Workers’ Role and Responsibilities. An interview with the PC on 4/10/24 at 8:56 a.m., revealed the following: - PC is a new employee, who was trained at a sister facility by another PC in November 2023, to assist with SW duties. PC started at this facility in December of 2023. - PC has been performing SW duties for patients at this clinic and for another clinic (sister facility). - PC stated that she does not have a degree in social work and has never worked in a SW position in the past; but has a degree in marketing. - PC assisted patients with transportation issues; completed weekly SW notes; assisted with transplant referrals and monitoring transplant status; checked into payment information for Medicare and Medicaid or payment sources for transportation and transplant; completed the KDQOL-36, and PHQ-9, which were checked and discussed with the LMSW. A review of the training documents for PC dated 1/3/24 did not show that PC received any SW related training. This surveyor requested a copy of PC’s job description and social work related training from the Facility Administrator (FA) six times during the survey, but the FA did not produce the requested documents. The Employee Audit form that was filled out and signed by the FA listed PC’s position as an SW. During an interview on 4/10/24 at 10:40 a.m., Staff XX stated the PC came here to cover and worked under a SW who was assigned to other clinics and the SW did not come here. During the exit interview on 4/10/24 at 3:30 p.m., the Medical Director (MD) and the Nurse Practitioner (NP) were informed of the above findings and concerns pertaining to the lack of a qualified LMSW, to meet the psychosocial needs of the patients. The MD and the NP did not offer additional information or comments. The FA was not present during the exit conference.”

“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: 03383 Based on a review of the facility’s Quality Assessment and Performance Improvement (QAPI) meeting minutes, and staff interviews, it was determined that the Medical Director (MD) failed to demonstrate operational responsibility for the facility’s QAPI program for six of six months (September 2023 - February 2024) meeting minutes requested and/or reviewed. This deficient practice had the potential to negatively impact the health and safety of 27 in-center hemodialysis patients who were under the care of this facility. Findings include: Cross References: V 627 - Failure of the MD to monitor QAPI indicators or performance measures that included water and dialysate quality safety and safe machine maintenance in six of six months (September 2023 - February 2024) meeting minutes requested and/or reviewed. V 638 - Failure of the QAPI Team to consistently monitor, track and trend facility’s performances and develop action plans to improve and sustain patient outcomes.”

“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: 03383 Based on a review of medical records, staff interview, and review of policy, it was determined that the medical director failed to ensure that all Direct Patient Care Staff adhered to facility policy and procedures pertaining to hypertension [elevated blood pressure (BP)] to ensure that two of two patients (P#2 and P#3) sampled, who experienced high BP readings during dialysis treatment, received medical care and supervision appropriate to patient’s dialysis needs. This deficient practice had the potential to negatively affect the health and safety of 27 patients who were dialyzing at this facility. Findings were: A review of P#2’s treatment flowsheets showed the following: On 4/1/24: - The initiation of P#2’s dialysis treatment began at 6:59 a.m. - P#2’s BP was 188/102 at 7:00 a.m.; 211/106 at 7:30 a.m.; 193/96 at 8:00 a.m.; 203/89 at 8:30 a.m.; 186/94 at 9:00 a.m.; 171/97 at 9:30 a.m.; 195/94 at 10:00 a.m. - There was a lack of documentary evidence that the nurse was notified of P#2’s high BP readings. - There was a lack of interventions done for the elevated BP readings during dialysis treatment. On 4/8/24: - The initiation of P#2’s dialysis treatment began at 7:10 a.m. - P#2’s BP was 180/99 at 7:13 a.m.; 191/98 at 7:30 a.m.; 186/93 at 8:30 a.m.; 191/91 at 9:00 a.m.; 182/94 at 9:30 a.m.; 196/95 at 10:00 a.m.; and 180/86 at 10:30 a.m. - There was a lack of documentary evidence that the nurse was notified of P#2’s high BP readings. - There was a lack of interventions done for the elevated BP readings during dialysis treatment. A review of P#3’s treatment flowsheets showed the following: On 3/27/24: - The initiation of P#3’s dialysis treatment began at 6:42 a.m. and his BP was 188/103. - P#3’s BP was 181/94 at 7:00 a.m.; 180/91 at 7:30 a.m.; 187/87 at 8:30 a.m.; 204/96 at 9:00 a.m.; and 190/85 at 9:30 a.m. - There was a lack of documented interventions done for the elevated BP readings during dialysis treatment. On 4/1/24: - The initiation of P#3’s dialysis treatment began at 6:37 a.m. and his BP was 171/94. - P#3’s BP was 180/114 at 8:00 a.m.; 165/101 at 8:30 a.m.; and 182/95 at 9:30 a.m. - There was a lack of documentary evidence that PCT informed the nurse about P#3’s high BP readings. - There was a lack of interventions done for the persistently elevated BP readings during dialysis treatment. On 4/5/24: - The initiation of P#3’s dialysis treatment began at 6:39 a.m. and his BP was 192/103. - P#3’s BP was 190/103 at 7:00 a.m.; 186/107 at 7:30 a.m.; 180/92 at 8:30 a.m.; and 186/100 at 9:30 a.m. - There was a lack of documentary evidence that PCT informed the nurse about P#3’s high BP readings. - There was a lack of interventions done for the elevated BP readings during dialysis treatment. On 4/8/24: - The initiation of P#3’s dialysis treatment began at 6:39 a.m. and his BP was 187/105. - P#3’s BP was 185/97 at 7:00 a.m.; 205/110 at 7:30 a.m.; and 187/101 at 9:30. a.m. - There was a lack of interventions done for the elevated BP readings during dialysis treatment. The above findings were discussed and reviewed with the Nurse Practitioner (NP) on 4/9/24 at 9:30 p.m. The NP indicated that the nurse should have been notified about the high BP readings. The Medical Director was informed of the above findings during the exit interview on 4/10/24 at 3:30 p.m. The MD did not offer additional information or comments. A review of policy titled, “Hypertension Management” revised 3/18/29 showed the following: Goal is to keep post dialysis BP <140/90 at all times but to avoid immediate complication in the dynamic disease, Post Dialysis BP of>180/100 to be treated on immediate basis. Procedure: 1. Check the patient’s blood pressure with the appropriate size cuff. If the reading is elevated reposition the cuff and check again. 2. If blood pressure is consistently greater than 180/100 during and/or after dialysis, a. Pt (Patient) must make appointment with their physician to be evaluated. b. Instruct patient to take prescribed BP medications at this time. c. Offer patient to take Clonidine 0.1 mg PO, and repeat dose after one hour if BP is still 180/90 if no obvious contraindications. d. Inform patient’s PMD and obtain order for further management.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 03383 Based on a review of records and staff interviews, it was determined that the facility failed to implement their internal grievance process to resolve six of seven patient complaints/grievances during the months of October 2023 - April 2024. The facility census was 27. Findings were: 1. A review of Complaint/Grievance Report filed by Patient #4 on 12/12/23 showed the following: Complaint/Grievance Description: Quality service, cleanliness, improper staff hygiene, staff lateness, dirty bathrooms and out of supplies. Resolution: Notified Administration The form was signed by the Facility Administrator. Below the signature was a comment that stated: “We are currently undergoing renovations to bring the facility upto date and create a greater atmosphere for the patients. Nurse (named) has been disciplined. We have hires (sic) 2 new techs to start Jan 1st to allow termination of late technician. Also ordered new machines”. The report was marked as pending. There was a lack of documented evidence that P#4 was informed of the status of the investigation and resolution. 2. This surveyor was provided with an undated document titled, “Grievance Policy” that showed the following: Number of Grievances/complaints received this month: 5 Complaints that require Governing Body/IDT interference: Yes. The blinds are broken. The billing question are not being answered. The patient (sic) are stating they feel pressured to switch their insurance around due to their insurance not paying enough. The patients are stating that if they ...(The sentence was cut off). Root Cause Analysis: Yes, administration has been made aware of this ongoing problem over and over again and nothing has been done. There was no documentation that showed resolution of grievances. Each grievance did not demonstate a completed cycle of reviewing the grievance, conducting investigation, and reporting back to the patient. The Facility Administrator (FA) was not available on 4/10/24 to answer questions about the above grievances. The Nurse Practitioner (NP) and Patient Coordinator were unable to answer questions related to the grievances listed above. The Medical Director and NP were informed of the above findings during the exit conference on 4/10/24 at 3:30 p.m., and did not offer additional information or comments. A review of undated policy titled, “Patient Complaint and Grievance and Resolution” showed the following: Patient/representative will be notified about resolution - outcome in expeditious way but no later than 2 business days.”