Coldsprings Dialysis, LLC

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, the facility’s Governing Body, Administration and the Medical Director failed to meet the Condition for Coverage (CfC: 494.80) for Patient Assessment, as evidenced by the facility’s administration and the Medical Director’s failure to ensure a safe and effective system for the evaluation of patients after treatment. This failure contributed to harm reaching patient #1 and placed all patients at increased risk for harm and/or death. Findings included: 1) Patient Assessment - Assess Current Health Status/cormorbids (V0502)”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, the facility failed to meet the Conditions for Coverage(CfC:494.150) for Responsibilities of The Medical Director, as evidenced by the facility’s Medical Director’s failure to ensure that the facility’s staff adhered to their own policies and procedures to deliver a safe and effective system for the evaluation of patients post treatment. This failure contributed to harm reaching patient #1 and placed all patients at increased risk for harm and/or death. Findings included: 1) Responsibilities of the Medical Director - Ensure All Adhere to Policy and Procedure (V0710)”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on staff interviews and review of documentation including medical record, policies, procedures and electronic communications, the facility failed to ensure patients received safe and effective post-procedural assessments when the facility allowed non-nursing staff to perform the assessments for which they were not qualified. Reliance on unqualified staff for the post-procedural assessments contributed to harm reaching patient #1; and increased the risk for serious harm to all patients affected by the noncompliant practice. Patient: #1 Findings included: Review on 12/5/2023 of facility’s policy entitled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revealed that data is collected and documented by the patient care technician (PCT) or licensed nurse; and that nursing assessments “will be performed and documented by ... a Registered Nurse (RN).” Review on 12/5/2023 of facility’s policy entitled “Care of Patient Post-Hemodialysis” revealed that the post-hemodialysis nursing assessment includes “Assessment of the AV fistula/graft strength of thrill and bruit after removal of both needles.” On 12/5/2023 at 10:30 a.m., review of the facility’s documents and interviews with the Clinical Manager revealed that on 11/29/2023, Patient #1’s dialysis treatment was ended by the Patient Care Technician (PCT) at 11:26 a.m. Review of the record flowsheet revealed that two 17 gauge needles were removed, the puncture sites bled for 15 minutes, and Patient #1 was discharged back to the nursing home co-located in the same buidling at 11:34 a.m. Review of an email from the nursing home’s Executive Director addressed to the Director of Dialysis Services on 11/29/2023 at 3:32 p.m., revealed that Patient #1 “was observed lying in bed in a pool of blood in [the] room by Charge Nurse with one dialysis needle near [the] left arm at the AV fistula site ... the dialysis nurse was contacted to assist and stated [he/she] could not come and was not coming.” Review of documentation by the dialysis Charge Nurse corroborated that the dialysis facility was notified of the bleeding and that a needle and clamp were found on the patient bed. On 12/5/23 interview at 1:30 PM, the facility Charge Nurse indicated that he/she only conducted the pre-procedural assessments, not the post-procedure assessments. The Charge nurse added that he/she relied on the PCT to assess each patient’s access post treatment. Both the Clinical Manager and the Director of Dialysis Services corroborated that it was facility practice for the PCT to conduct these post-procedural assessments.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44367 Based on staff interviews and review of documentation including medical record, policies, procedures and electronic communications, the facility failed to ensure that qualified staff evaluated vascular access of patients following procedures and prior to discharge. Reliance on unqualified staff to assess vascular access after dialysis procedures and before discharge contributed to harm reaching patient #1; and increased the risk for serious harm to all patients affected by the noncompliant practice. Patient: #1 Findings included: Review on 12/5/2023 of facility’s policy entitled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revealed that data is collected and documented by the patient care technician (PCT) or licensed nurse; and that nursing assessments “will be performed and documented by ... a Registered Nurse (RN).” Review on 12/5/2023 of facility’s policy entitled “Care of Patient Post-Hemodialysis” revealed that the post-hemodialysis nursing assessment includes “assessment of the AV fistula/graft strength of thrill and bruit after removal of both needles.” On 12/5/2023 at 10:30 a.m., review of the facility’s documents and interviews with the Clinical Manager revealed that on 11/29/2023, Patient #1’s dialysis treatment was ended by the Patient Care Technician (PCT) at 11:26 a.m. Review of the record flowsheet revealed that staff documented two 17 gauge needles were removed, the puncture sites bled for 15 minutes, and Patient #1 was discharged back to their nursing home co-located in the same building at 11:34 a.m. Review of a written statement from the PCT revealed he/she recalled pulling “one needle.” Review of an email from the nursing home’s Executive Director addressed to the Director of Dialysis Services on 11/29/2023 at 3:32 p.m., revealed that Patient #1 “was observed lying in bed in a pool of blood in [the] room by Charge Nurse with one dialysis needle near [the] left arm at the AV fistula site ... the dialysis nurse was contacted to assist and stated [he/she] could not come and was not coming.” Review of documentation by the dialysis charge nurse corroborated that the dialysis facility was notified of the bleeding and that a needle and clamp were found on the patient bed in the nursing home. On 12/5/23 interview at 1:30 p.m., the facility Charge Nurse indicated that he/she only conducted the pre-procedural assessments, not the post-procedure assessments. The Charge nurse added that he/she relied on the PCT to assess each patient’s access post treatment. Both the Clinic Manager and the Director of Dialysis services corroborated that it was facility practice for the PCT to conduct these post-procedural assessments. Within the facility operational process, no evidence was found that qualified nursing staff assessed patient vascular access after procedures and before discharge.”

“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: 44367 Based on staff interviews and review of documentation including medical record, policies, procedures, employee files and electronic communications, the facility’s governing body failed to ensure all staff performed duties within their scope of practice when the facility allowed non-licensed staff to perform assessments for which they were not qualified. Reliance on unqualified staff for patient assessments violated the facility’s policies and state laws; and increased the risk for serious harm to all patients affected by the noncompliant practice. Findings included: Review on 12/5/2023 of facility’s policy entitled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revealed that data is collected and documented by the patient care technician (PCT) or licensed nurse; and that nursing assessments “will be performed and documented by ... a Registered Nurse (RN).” Review of 12/5/2023 of the Maryland “Nurse Practice Act” regulation 10.27.11 page 6 .05 A.(1), “Nursing Functions: A. The following nursing functions require knowledge, judgement, and skills and may not be delegated: (1) The nursing assessment including, but not limited to, the admission, transfer, and discharge assessment.” On 12/5/2023, review of the Patient Care Technician (PCT) #1’s employee file revealed he/she held a certification as a CNA-DT (Certified Nursing Assistant - Dialysis Technician), which was issued 1/5/2007 and with an expiration date of 5/28/2025. The certification is a non-licensed position, which does not permit the performance of a nursing assessment and the task cannot be delegated. On 12/5/23 interview at 1:30 PM, the facility Charge Nurse indicated that he/she only conducted the pre-procedural assessments, not the post-procedure assessments. The Charge nurse added that he/she relied on the PCT to assess each patient’s access post treatment. Both the Clinic Manager and the Director of Dialysis services corroborated that it was facility practice for the PCT to conduct these post-procedural assessments.”

“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: 44367 Based on staff and governing body interviews, and review of the facility’s policies and procedures, the Medical Director and the governing body failed to ensure that the facility’s staff members adhered to their own policies and procedures regarding post care treatment of a dialysis patient. The governing body’s failure to ensure staff followed facility policy contributed to actual harm and placed all patients at increased risk for serious harm. Findings included: Review of the facility’s policy and procedures, interviews with the facility’s staff on 12/5/2023 revealed that the Charge Nurse and the Patient Care Technician did not follow policy and procedure regarding removing fistula needles and ensuring a nursing assessment of the patient’s access was completed prior to discharge. Cross reference tags: 1. V0502 for the facility’s policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” and “Care of Patient Post-Hemodialysis.” 2. V0550 for the facility’s policy “Care of Patient Post-Hemodialysis” and AV Fistula or Vein Graft - Initiating and Termination Dialysis For Mature Access The Medical Director, Director of Dialysis Services and the Clinical Manager corroborated the findings on 12/8/2023.”