Innovative Renal Care Hockessin

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(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: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 30177 Based on document review and interview, the facility failed to ensure the emergency contact list included the Biomedical Technician (BMT), Regional Operations Manager, Home Training Nurse, and Administrative Assistant, as well as documentation of a primary and alternate means for communicating with those staff members. The failure had the potential to hinder the facility’s ability to respond promptly to an emergency and had the potential to delay emergency assistance, thus negatively affecting the 36 in-center hemodialysis patients receiving care at this facility. Findings include: Review of an undated document titled, “Employee Tracking Form,” located in the “Emergency Preparedness Plan,” revealed the document omitted the BMT, Regional Operations Manager, Home Training Nurse, and Administrative Assistant. Interview with the Regional Operations Manager, who is the Acting Facility Administrator and the Acting Clinical Manager, on 08/22/24 at 12:53 PM, the Regional Operations Manager confirmed the facility’s staff roster omitted him/herself, the BMT, Home Training Nurse, and the Administrative Assistant, which there was no alternate means for communicating with all staff members. The Regional Operations Manager was asked what the facility’s policy is for ensuring the employee contact information, including primary and alternate forms of communication, is available. The Facility Administrator stated that the employees’ contact information must be reviewed and updated. The Facility Administrator confirmed that the facility staff emergency contact roster should have included the current BMT and an alternate means of communication with all staff.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 30177 Based on interview and facility policy review, the facility failed to ensure 7 of 7 staff (Certified Clinical Hemodialysis Technician (CCHT) 1, CCHT2, Social Worker, Administrative Assistant, Registered Nurse (RN)1, RN2, Home Training Nurse, and Regional Operations Manager) were trained and demonstrated knowledge of emergency procedures, including informing patients of what to do, where to go, and whom to contact if an emergency occurs while the patient is not in the dialysis facility; including informing patients of an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls. Failure to ensure staff was trained and competent in all aspects of the emergency preparedness plan had the potential to delay staff response during an emergency and hinder the welfare and safety of the 36 in-center hemodialysis and the three peritoneal dialysis patients receiving care at this facility. Findings include: Review of the facility’s policy, “Associates Training & In-Services,” revised 12/22/23 revealed “Each IRC [Innovative Renal Care] center associate must meet the personal qualifications and demonstrate competencies necessary to provide needed patient care. All new IRC associates will complete the IRC training course currently used for their job roles as appropriate for their position and level of experience. The center’s Medical Director is responsible for ensuring that all center associates receive the appropriate education and training to competently perform their job responsibilities... The IRC training course for PCTs [Patient Care Technicians] shall include all subjects noted in the current conditions for coverage... In-services shall be conducted in each center on a regular basis, but no less often than once every two months...” In an interview on 08/21/24 at 3:31 PM, CCHT2, RN2, Social Worker, Administrative Assistant, and Home Training Nurse were asked if they had been trained to inform patients of what to do, where to go, and whom to contact, including an alternate phone number for instances when the dialysis facility is unable to receive phone calls during an emergency. All staff, as listed above, indicated a response of “No.” In an interview on 08/22/24 at 10:15 AM, CCHT1 and RN1 were asked, do you know where to locate the facility’s alternate emergency contact or phone numbers for instances when the dialysis facility cannot receive phone calls if the facility is closed unexpectedly due to an emergency? Both CCHT1 and RN1 replied, “No.” When asked, have you been trained in informing patients of what to do, where to go, and whom to contact, including informing patients of an alternate phone number for instances when the dialysis facility is unable to receive phone calls during an emergency? CCHT1 and RN1 replied, “No.” Interview on 08/22/24 at 2:45 PM, the Regional Operations Manager was asked to provide evidence of staff training on informing patients of what to do, where to go, and whom to contact, as well as the facility’s alternate emergency phone number. The Regional Operations Manager revealed he/she had no documentation indicating that staff, including him/herself, had been trained to inform patients what to do, where to go, whom to contact, and an alternate phone number in the event of an emergency. The Regional Operations Manager confirmed that he/she had no documentation that the staff was provided the emergency alternate phone number. The Regional Operations Manager also confirmed that the staff is responsible for educating the patients on what to do, where to go, whom to contact, and an alternate emergency phone number.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 30177 Based on observation, staff interview, and policy review, the facility failed to restrict access to the water purification system to only those approved individuals who had been trained and were responsible for monitoring and maintaining the water purification system. Failure to restrict access to the water purification system to only those employees who had been trained and responsible for the water system had the potential to negatively impact the safety and well-being of the 36 in-center hemodialysis patients receiving treatments at this facility. Findings include: Flash tour observation on 08/21/24 at 12:50 PM revealed that the door designated as the entrance to the Water Treatment Room, which housed the Water Purification System, contained a keyless entry lock and opened with a four-digit security code. The same four-digit security code provided access to the door to the hemodialysis treatment floor, which was used by all staff, including the Social Worker, Administrative Assistant, and float staff (staff members from other facilities). During an interview on 08/24/24 at 2:00 PM, the Biomedical Technician (BMT) confirmed that staff untrained in hemodialysis water monitoring and maintenance, including the facility’s Social Worker, Administrative Assistant, and float staff, had access to the water purification system. The BMT stated he/she was unaware of the need to restrict entrance to the water purification system for individuals who had not been trained and responsible for the water system. Review of the facility’s policy titled, “Water Purification System Security,” revision date 02/05/24, revealed, “The water purification system will be kept secure, and entry will only be allowed to individuals responsible for monitoring and maintenance of the system. Only authorized personnel will have access to The Water Purification System’s room ...””

“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: 30177 Based on observation, staff interview, and policy review, the facility failed to maintain the integrity of surfaces in the water and patient treatment areas. Failure to maintain the integrity of surfaces allowed an accumulation of grime and rust, rendering the surfaces porous. Rust accumulation in the water room had the potential to transfer accumulated rust into the water system, which can potentially contaminate the water and expose the patients to contaminates. This failure created a patient safety hazard and had the potential to affect all 36 in-center hemodialysis patients at this facility negatively. Findings Include: Observation of the “Water Treatment Room” on 08/21/24 at 10:30 AM with the Biomedical Technician (BMT); the following observations were made and confirmed by the BMT: 1. An excessive accumulation of rust on top of three of three endotoxin filter housings. 2. The brine tank had spots of a white powdery substance on the exterior surface. Observation of the “Patient Treatment Area,” on 08/21/24 at 10:45 AM with the Facility Administrator; the following observations were made and confirmed: 1. The floor behind stations two and three was noted to have a considerable accumulation of white powdery substance, dirt, and grime. 2. The countertop formica on the “Clean Sink” had visible areas where the formica showed degradation. 3. The wall in the isolation room behind the dialysis machine displayed an area with spots of a white substance, which created a disheveled and unkempt appearance. 4. The drain in the wall boxes in Stations 1, 5, 7, and 8 had an accumulation of suds from the drain. 5. The handwashing sink in the Isolation Room was noticeably coated with a substantial accumulation of dark brown, grimy substance. 6. Three carts used to store clean supplies showed a conspicuous white crystal/chalky substance accumulation. 7. Ten of twelve wall boxes (Stations 1, 2, 3, 5, 6, 7, 8, 9, 10, and the Isolation Room) had a visibly tinged hue ranging from pink to reddish with a dark, brown build-up of grimy substance. 8. Three windows showed a conspicuous accumulation of spider webs in the lower corners of the windows. 9. The ledge behind the treatment stations contained an accumulation of a white crystal/chalky substance. In an interview with the Regional Operations Manager on 08/22/24 at 4:15 PM, a policy was requested for the initiation and maintenance of a clean and sanitary environment. No policy was provided by the survey exit date.”

“GOV-STAFF HAVE ACCESS TO CONTINUING ED CFR(s): 494.180(b)(4) The governing body or designated person responsible must ensure that- (4) All employees have an opportunity for continuing education and related development activities This Standard is not met as evidenced by: 30177 Based on staff interview, personnel file review, and review of the facility’s policy, the facility failed to ensure staff had an opportunity for internal training programs and external professional continuing education and related development activities/in-services to help maintain and improve their knowledge and skills. This failed practice did not ensure staff maintained their knowledge and skills to care for the complex needs of the 36 in-center hemodialysis patients and the three peritoneal dialysis patients receiving care at this facility. Findings include: Interview with a confidential staff member on 08/21/24 at 1:00 PM stated that the facility does not have a Charge Nurse for the Monday, Wednesday, and Friday shifts, and the Facility Administrator/Clinical Manager is no longer working at the facility, a Registered Nurse recently quit a couple of weeks ago, the Registered Dietitian quit the facility as well, and the facility uses staff from other locations who at times may not be as knowledgeable. During an interview with seven of the seven staff (Certified Clinical Hemodialysis Technician (CCHT) 1, CCHT2, Social Worker, Administrative Assistant, Registered Nurse (RN)1, RN2, and the Home Training Nurse) and the Regional Operations Manager on 08/21/24 at 1:15 PM and 08/22/24 at 2:15 PM, the staff members were asked what educational in-services were offered for staff to maintain their knowledge and skills. All staff members verbalized that the facility did not offer educational in-services to help maintain and improve their knowledge and skills. During a follow-up interview with the Regional Operations Manager on 08/22/24 at 3:45 PM, it was stated that the facility is currently working on recruiting staff members and recognizes the importance of providing continuing education programs to help staff maintain and enhance their knowledge and skills. The Regional Operations Manager was asked to provide documentation where the Medical Director signed the documents that demonstrate the associate’s successful completion of the orientation training program. The Regional Operations Manager was unable to provide documentation where the Medical Director signed demonstrating the staff members successful completion of the facility’s orientation training program. Review of the facility’s policy titled, “Associates Training & In-Services,” revised 12/22/23 revealed “The center’s Medical Director is responsible for ensuring that all center associates receive the appropriate education and training to competently perform their job responsibilities. The Medical Director must sign the documents that demonstrate the associate’s successful completion of the orientation training program...Ongoing education shall be made available to all employees... In-services shall be conducted in each center on a regular basis, but no less often than once every two months ...” In an interview with the Medical Director on 08/23/24 at 11:30 AM, he/she was asked how he/she ensures staff have opportunities to professional continuing education and related development activities/in-services to help maintain and improve their knowledge and skills. The Medical Director stated that the Manager is responsible for the training.”