Fmc of North Charlotte

“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: 27438 Based on policy review, manufacturer’s DFU, observations, and staff interviews, the facility staff failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not monitoring and maintaining the arterial drip chamber fluid levels at 90% full during treatment for 2 of 2 observations and the facility failed to remove expired medication from their active inventory for 1 of 1 observation of the medication area. Findings included: Review of the “Combi Set Hemodialysis Blood Tubing Set with attached Priming Set,” manufacturer’s DFU used at this facility revealed, “During Treatment: Maintain fluid level in arterial chamber at approximately 90% full....” Review of the facility’s policy, “Medication Preparation and Administration,” published February 6, 2023 revealed, “Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on a monthly basis.” 1. Observations on January 29, 2024 at 12:10 PM revealed, the arterial drip chamber fluid levels were less than 50% full in Stations #5, #6, #8, #9, #15, #16, #17, #22, #23, #24, #28, and #29. Interview on January 29, 2024 at 1:00 PM with RN #11 revealed, the arterial chamber levels at Stations #5 and #6 were below 50% and staff are responsible to observe the chamber levels during treatment and adjust the level as needed. 2. Observations on January 30, 2024 at 3:55 PM revealed the arterial drip chamber fluid levels were less than 10% full in Station #27. Interview on January 30, 2024 at 3:55 PM, with PCT #9 revealed, the technician was unable to provide the manufacturers recommendation that arterial drip chamber fluid levels should be 90% full during treatment. 3. Observation on January 29, 2024 at 2:25 PM of the medication area revealed, two bottles of Calcitriol Capsules (active form of vitamin D) 0.25 mg had DFU expiration dates on the bottles of 11/2023 and were found in the cabinet with unexpired oral medications. Interview on January 29, 2024 at 2:45 PM with RN #11 revealed, the expired supplies should be removed and disposed of when expired.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 35306 Based on observations, interviews and email correspondence review, the facility staff failed to ensure compliance with the provisions of the Life Safety Code (LSC) of the National Fire Protection Association (NFPA) 101, section 19.7.8 in regard to the use of electric space heaters in the patient lobby waiting area in 1 of 2 observations. Findings included: Observation on 01/29/2024 at 0950 upon entry into the facility revealed, one (1) space heater was in the patient lobby waiting area with three (3) patients present. Interview on 01/29/2024 at 1105 with the Facility Administrator (FA) revealed the front lobby temperature was difficult to regulate due to the front door being opened so often with patients entering and exiting the facility and no way to separate the waiting area and entrance area. Email correspondence review on 01/31/2024 at approximately 0910 from the Senior Regulatory Manager, presented by the facility Director of Operations (DO), revealed “... the facility must make reasonable efforts to provide a comfortable environment for patients and staff, in spite of conflicting perceptions of “comfortable.” ... The facility must develop an acceptable plan to determine the temperature in the patient treatment area.” Email correspondence review on 01/31/2024 at 1104 from the Life Safety Engineering Supervisor from Health Services Regulations revealed, space heaters were “only allowed to be used in Staff/employee areas and the heating elements cannot exceed 212 degF [degrees Fahrenheit].” Collaborative information confirmed noncompliance with the provisions of the Life Safety Code (LSC) of the National Fire Protection Association (NFPA) 101, section 19.7.8 heaters in regard to the use of electric space heaters in the patient lobby waiting area in 1 of 2 observations.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 35306 Based on facility policy review, medical record reviews, and staff interview, the facility staff failed to obtain a blood pressure and pulse rate a minimum of every 45 minutes during hemodialysis treatments for 5 of 10 sampled in-center hemodialysis records reviewed (Patients #1, #3, #5, #6 and #7); the facility staff failed to document safety checks a minimum of 45 minutes for 5 of 10 sampled in-center hemodialysis records reviewed (Patients #1, #2, #3, #5, and #7); the facility staff failed to notify the nurse of low blood pressure readings during hemodialysis for 1 of 10 sampled in-center hemodialysis records reviewed (Patient #6); the facility nursing staff failed to document a post-treatment nursing assessment for 1 of 10 in-center hemodialysis records reviewed (Patient #6); failed to document nursing assessments for patients with low blood pressure readings during hemodialysis for 1 of 10 sampled in-center hemodialysis records reviewed (Patient #6), and failed to administer Clonidine per physician order for 1 of 2 sampled in-center hemodialysis records reviewed of patients with prn Clonidine orders (Patient #5). Findings included: 1. Review on 01/31/2024 of the facility policy titled, “Patient Assessment and Monitoring” Published: 05/01/2023, revealed, “... During Treatment Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. a. Medical record review on 01/29/2024 for Patient #1 revealed a 54-year-old female was admitted for In-Center Hemodialysis treatments on 10/09/2017. Review of the physician ordered “Patient Management Services” revealed BP and Pulse “Pre/Post Dialysis, q30min [every 30 minutes] while on dialysis and PRN” was ordered on 01/22/2024 with a stop date of 01/20/2025. Review of the Treatment Flowsheet for 01/17/2024 revealed the staff documented the patient’s blood pressure and pulse 0903 and the next documentation was at 1021 (78 minutes later). Review of the Treatment Flowsheet for 01/22/2024 revealed the staff documented the patient’s blood pressure and pulse at 0724 and the next documentation was at 0859 (94 minutes later). Review of the Treatment Flowsheet for 01/24/2024 revealed the staff documented the patient’s blood pressure and pulse at 0927 and the next documentation was at 1022 (55 minutes later). Review of the Treatment Flowsheets revealed the facility staff failed to document Patient #1’s blood pressure and pulse every 30 minutes as ordered on 01/17/2024 and 01/24/2024. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed staff were expected to obtain and document the blood pressure and pulse a minimum of every 45 minutes, unless there was a physician order indicating otherwise. Interview revealed staff failed to document the patient’s blood pressure and pulse as ordered. Interview on 01/31/2024 at 1420 with the Medical Director revealed that the patient’s blood pressure and pulse should be obtained and documented per physician order or facility policy. b. Medical record review on 01/29/2024 for Patient #3 revealed a 62-year-old male was admitted for In-Center Hemodialysis treatments on 10/16/2015. Review of the Treatment Flowsheet for 01/15/2024 revealed the staff documented the patient’s blood pressure and pulse at 0558 and the next documentation was at 0700 (62 minutes later). Review of the Treatment Flowsheet for 01/19/2024 revealed the staff documented the patient’s blood pressure and pulse at 0829 and the next documentation was at 0930 (61 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed staff were expected to obtain and document the blood pressure and pulse a minimum of every 45 minutes, unless there was a physician order indicating otherwise. Interview revealed staff failed to document the patient’s blood pressure and pulse per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that the patient’s blood pressure and pulse should be obtained and documented per physician order or facility policy. c. Medical record review on 01/30/2024 for Patient #5 revealed a 51-year-old male was admitted for In-Center Hemodialysis treatments on 08/18/2020. Review of the physician ordered “Patient Management Services” revealed BP and Pulse “Pre/Post Dialysis, q30min [every 30 minutes] while on dialysis and PRN” was ordered on 01/09/2024 with a stop date of 01/07/2025. Review of the Treatment Flowsheet for 01/19/2024 revealed the staff documented the patient’s blood pressure and pulse at 0829 and the next documentation was at 0930 (61 minutes later). Review of the Treatment Flowsheet for 01/20/2024 the staff documented the patient’s blood pressure and pulse at 0705 and the next documentation was at 0803 (58 minutes later). Further review of the Treatment Flowsheet revealed at 0830, the staff documented the patient’s blood pressure and pulse, and the next documentation was at 0930 (60 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed staff were expected to obtain and document the blood pressure and pulse a minimum of every 45 minutes, unless there is a physician order indicating otherwise. Interview confirmed the findings. Interview on 01/31/2024 at 1420 with the Medical Director revealed that the patient’s blood pressure and pulse should be obtained and documented per physician order or facility policy. d. Medical record review on 01/30/2024 for Patient #6 revealed an 81-year-old male was admitted for In-Center Hemodialysis treatments on 03/22/2012. Review of the physician ordered “Patient Management Services” revealed BP and Pulse “Pre/Post Dialysis, q30min [every 30 minutes] while on dialysis and PRN” was ordered on 05/30/2023 with a stop date of 05/28/2024. Review of the Treatment Flowsheet for 01/23/2024 revealed the staff documented the patient’s blood pressure and pulse at 0801and the next documentation was at 0901(60 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed staff were expected to obtain and document the blood pressure and pulse a minimum of every 45 minutes, unless there is a physician order indicating otherwise. Interview confirmed the findings. Interview on 01/31/2024 at 1420 with the Medical Director revealed that the patient’s blood pressure and pulse should be obtained and documented per physician order or facility policy. e. Medical record review on 01/30/2024 for Patient #7 revealed a 38-year-old male was admitted for In-Center Hemodialysis treatments on 04/29/2014. Review of the physician ordered “Patient Management Services” revealed BP and Pulse “Pre/Post Dialysis, q30min [every 30 minutes] while on dialysis and PRN” was ordered on 01/22/2024 with a stop date of 01/20/2025. Review of the Treatment Flowsheet for 01/22/2024 revealed the staff documented the patient’s blood pressure and pulse at 1525 and the next documentation was at 1628 (63 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed staff were expected to obtain and document the blood pressure and pulse a minimum of every 45 minutes, unless there is a physician order indicating otherwise. Interview confirmed the findings. Interview on 01/31/2024 at 1420 with the Medical Director revealed that the patient’s blood pressure and pulse should be obtained and documented per physician order or facility policy. 2. Review on 01/31/2024 of the facility policy titled, “Patient Assessment and Monitoring” Published: 05/01/2023, revealed, “... Document....safety checks every 30 minutes or more often as needed but not to exceed 45 minutes per state regulations...” a. Medical record review on 01/29/2024 for Patient #1 revealed a 54-year-old female was admitted for In-Center Hemodialysis treatments on 10/09/2017. Review of the Treatment Flowsheet for 01/17/2024 revealed the staff documented a safety check at 0903 and the next documentation was at 1021 (78 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed that staff were expected to perform safety checks every 30 minutes to include visualizing the access sites, check for wet transducers, and machine parameters. Interview revealed the facility policy allows a 15-minute grace period and required that a safety check be performed a minimum of every 45 minutes. Interview revealed the staff should have documented the safety checks a minimum of every 45 minutes. Interview revealed staff failed to document safety checks per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that safety checks should be performed and documented per facility policy. b. Medical record review on 01/29/2024for Patient #2 revealed a 66-year-old male was admitted for In-Center Hemodialysis treatments on 01/05/2017. Review of the Treatment Flowsheet for 01/17/2024 revealed the staff documented a safety check at 1300 and the next documentation was at 1400 (60 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed that staff were expected to perform safety checks every 30 minutes to include visualizing the access sites, check for wet transducers, and machine parameters. Interview revealed the facility policy allows a 15-minute grace period and required that a safety check be performed a minimum of every 45 minutes. Interview revealed the staff should have documented the safety checks a minimum of every 45 minutes. Interview revealed staff failed to document safety checks per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that safety checks should be performed and documented per facility policy. c. Medical record review on 01/29/2024 for Patient #3 revealed a 62-year-old male was admitted for In-Center Hemodialysis treatments on 10/16/2015. Review of the Treatment Flowsheet for 01/19/2024 revealed the staff documented a safety check at 0829 and the next documentation was at 0930 (61 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed that staff were expected to perform safety checks every 30 minutes to include visualizing the access sites, check for wet transducers, and machine parameters. Interview revealed the facility policy allows a 15-minute grace period and required that a safety check be performed a minimum of every 45 minutes. Interview revealed the staff should have documented the safety checks a minimum of every 45 minutes. Interview revealed staff failed to document safety checks per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that safety checks should be performed and documented per facility policy. d. Medical record review on 01/30/2024 for Patient #5 revealed a 51-year-old male was admitted for In-Center Hemodialysis treatments on 08/18/2020. Review of the Treatment Flowsheet for 01/19/2024 revealed the staff documented safety monitoring at 0829 and the next documentation was at 0930 (61 minutes later). Review of the Treatment Flowsheet for 01/20/2024 revealed the staff documented a safety check at 0700 and the next safety check was documented at 0803 (63 minutes later). Further review of the Treatment Flowsheet revealed at 0830, the staff documented a safety check, and the next documentation was at 0930 (60 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed that staff were expected to perform safety checks every 30 minutes to include visualizing the access sites, check for wet transducers, and machine parameters. Interview revealed the facility policy allows a 15-minute grace period and required that a safety check be performed a minimum of every 45 minutes. Interview revealed the staff should have documented the safety checks a minimum of every 45 minutes. Interview revealed staff failed to document safety checks per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that safety checks should be performed and documented per facility policy. e. Medical record review on 01/30/2024 for Patient #7 revealed a 38-year-old male was admitted for In-Center Hemodialysis treatments on 04/29/2014. Review of the Treatment Flowsheet for 01/22/2024 revealed the staff documented safety monitoring at 1525 and the next documentation was at 1628 (63 minutes later). Interview on 01/31/2024 at 1355 with the Facility Administrator revealed that staff were expected to perform safety checks every 30 minutes to include visualizing the access sites, check for wet transducers, and machine parameters. Interview revealed the facility policy allows a 15-minute grace period and required that a safety check be performed a minimum of every 45 minutes. Interview revealed the staff should have documented the safety checks a minimum of every 45 minutes. Interview revealed staff failed to document safety checks per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that safety checks should be performed and documented per facility policy. 3. Review on 01/31/2024 of the facility policy titled, “Patient Assessment and Monitoring” Published: 05/01/2023, revealed, “... Blood Pressure Report to the nurse: Systolic blood pressures greater than 180 mm/Hg - Diastolic blood pressure greater than 100 mm/Hg - Blood pressure less than or equal to 100 mm/hg [sic] systolic...” a. Medical record review on 01/29/2024 for Patient #2 revealed a 66-year-old male was admitted for In-Center Hemodialysis treatments on 01/05/2017. Review of the Treatment Flowsheet for 01/26/2024 revealed the documented blood pressure at 1055 was 99/56, 97/49 at 1331, and 98/52 at 1358 with no documentation of nursing notification. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed the facility patient care staff are trained to report any abnormal finding to the nurse, including blood pressure. Interview revealed the patient care staff should report high or low blood pressures during treatment to the nurse for assessment and evaluation of the patient. Interview revealed the patient care staff failed to follow policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that patients experiencing high or low blood pressures as defined by facility policy should be reported to the nurse for follow up evaluation of the patient’s pre-treatment medication regimen, if indicated, such that adjustments could be made, if needed. Interview revealed the patient care staff failed to follow policy. b. Medical record review on 01/29/2024 for Patient #4 revealed a 49-year-old male was admitted for In-Center Hemodialysis treatments on 09/23/2023. Review of the Treatment Flowsheet for 01/24/2024 revealed the patient dialyzed from 1025-1355 (3 hours, 30 minutes). At 1328, the blood pressure was documented as 139/75 and 97/59 at 1355 with no documentation of nursing notification. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed the facility patient care staff are trained to report any abnormal finding to the nurse, including blood pressure. Interview revealed the patient care staff should report high or low blood pressures during treatment to the nurse for assessment and evaluation of the patient. Interview revealed the patient care staff failed to follow policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that patients experiencing high or low blood pressures as defined by facility policy should be reported to the nurse for follow up evaluation of the patient’s pre-treatment medication regimen, if indicated, such that adjustments could be made, if needed. Interview revealed the patient care staff failed to follow policy. c. Medical record review on 01/30/2024 for Patient #5 revealed a 51-year-old male was admitted for In-Center Hemodialysis treatments on 08/18/2020. Review of the Treatment Flowsheet on 01/16/2024 revealed the patient dialyzed from 0713-1159 (4 hours, 46 minutes). The documented blood pressure at 0918 was 181/100 and 204/93 at 0949 with no documentation of nursing notification. Review of the Treatment Flowsheet for 01/18/2024 revealed the patient dialyzed from 0805-1300 (4 hours, 55 minutes). The documented blood pressure at 0805 was 180/100 and 177/101 at 0836. At 0930, the blood pressure was documented as 195/115, 197/108 at 1000, 175/111 at 1030, 191/111 at 1100, and 177/103 at 1130 with no documentation of nursing notification. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed the facility patient care staff are trained to report any abnormal finding to the nurse, including blood pressure. Interview revealed the patient care staff should report high or low blood pressures during treatment to the nurse for assessment and evaluation of the patient. Interview revealed the patient care staff failed to follow policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that patients experiencing high or low blood pressures as defined by facility policy should be reported to the nurse for follow up evaluation of the patient’s pre-treatment medication regimen, if indicated, such that adjustments could be made, if needed. Interview revealed the patient care staff failed to follow policy. d. Medical record review on 01/30/2024 for Patient #6 revealed an 81-year-old male was admitted for In-Center Hemodialysis treatments on 03/22/2012. Review of the Treatment Flowsheet for 01/16/2024 revealed the patient dialyzed from 0611-0939 (3 hours, 28 minutes). The documented blood pressure at 0830 was 105/70 and 96/56 at 0855 with no documentation of nursing notification. Further review of the Treatment Flowsheet revealed the documented blood pressure at 0926 was 89/64 with a note by the PCT stating, “Patient alert; bp dropped pt [patient] stable uf [ultrafiltration] off.” with no documentation of nursing notification. Review of the Treatment Flowsheet for 01/18/2024 revealed the patient dialyzed from 0625-0936 (3 hours, 11 minutes). At 0626, the blood pressure was documented as 109/63 and 94/51 at 0701 with no documentation of nursing notification. Further review of the Treatment Flowsheet revealed at 0728, the blood pressure was documented as 104/60, 92/56 at 0758 and 95/53 at 0834 with no documentation of nursing notification. Review of the Treatment Flowsheet for 01/20/2024 revealed the patient dialyzed from 0638-0946 (3 hours, 8 minutes). The documented blood pressure at 0755 was 101/47 and 89/48 at 0834 with no documentation of nursing notification. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed the facility patient care staff are trained to report any abnormal finding to the nurse, including blood pressure. Interview revealed the patient care staff should report high or low blood pressures during treatment to the nurse for assessment and evaluation of the patient. Interview revealed the patient care staff failed to follow policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that patients experiencing high or low blood pressures as defined by facility policy should be reported to the nurse for follow up evaluation of the patient’s pre-treatment medication regimen, if indicated, such that adjustments could be made, if needed. Interview revealed the patient care staff failed to follow policy. 4. Review on 01/31/2024 of the facility policy titled, “Patient Assessment and Monitoring” Published: 05/01/2023, revealed, “... The purpose of this policy is to provide guidance to [Organization name] direct patient care staff on assessment and monitoring patients before, during and after treatment. Responsibility Direct patient care staff (RN, LPN/LVN, PCT) ... Data Collection Direct patient care staff may collect data such as ... BP ... general observations ... If the PCT/LPN note any changes or abnormal findings in the patient’s condition ... the registered nurse must assess the patient. * The RN will notify the patient’s physician/physician extender of any abnormal findings, if necessary, based on clinical judgment for additional instruction. The Registered Nurse will assess/reassess any findings addressed pre or during treatment as needed. Post-Treatment Follow the steps below for obtaining post-treatment assessment data ... Blood Pressure Ensure vital signs and overall condition are stable for discharge ... Evaluate access prior to discharge ... Lungs sounds Edema Heart sounds The registered nurse will assess/re-assess post treatment as indicated... 2. Document findings in the patient’s record.” Review on 01/31/2024 of the facility policy titled, “Nursing Supervision and Delegation” Published: 11/06/2023, revealed, “... Record Review The record must be reviewed for... Low or high blood pressures... addressed by the registered nurse with documentation present - Blood pressures < 100 systolic or greater than 180 systolic addressed by the registered nurse with or [sic] documentation present...” Medical record review on 01/30/2024 for Patient #6 revealed an 81-year-old male was admitted for In-Center Hemodialysis treatments on 03/22/2012. Review of the Treatment Flowsheet for 01/16/2024 revealed the patient dialyzed from 0611-0939 (3 hours, 28 minutes). The patient’s blood pressure was documented as 93/55 at 0939 with documentation from the PCT stating, “tx [treatment] complete discomfort nurse aware.” Review of the Treatment Flowsheet revealed there was no documented post-treatment nursing assessment completed per policy. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed, “No documented pre or post-treatment nursing assessment is not acceptable under any circumstances.” Interview revealed abnormal findings should be reported to the nurse and that there should be documentation by the nurse either during the hemodialysis treatment or in the pre- or post-treatment nursing assessment. Interview revealed the facility nursing staff failed to document a post-treatment assessment per policy. 5. Review on 01/31/2024 of the facility policy titled, “Nursing Supervision and Delegation” Published: 11/06/2023, revealed, “... Reporting of Patient Care Findings to the Team Nurse in Charge The staff member who collects information pre, post and during treatment will document their findings... Registered nurses who are not the nurse in charge must report abnormal findings and interventions to the nurse in charge. Daily Treatment Prior to discharge, the RN must review the treatment record to: Confirm patient is stable for discharge ... Record Review The record must be reviewed for... Low or high blood pressures... addressed by the registered nurse with documentation present - Blood pressures < 100 systolic or greater than 180 systolic addressed by the registered nurse with or [sic] documentation present...” a. Medical record review on 01/29/2024for Patient #2 revealed a 66-year-old male was admitted for In-Center Hemodialysis treatments on 01/05/2017. Review of the Treatment Flowsheet for 01/26/2024 revealed the patient dialyzed from 1018-1433 (4 hours, 15 minutes). The documented blood pressure at 1055 was 99/56, 97/49 at 1331, and 98/52 at 1358 with post-treatment nursing assessment stating, “Patient completed treatment without complaints, issues vss [vital signs stable].” Review of the nursing assessment revealed no documented nursing assessment in follow up of the patient’s low blood pressure readings during hemodialysis. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed abnormal findings should be documented by the nurse either during the hemodialysis treatment or in the pre- or post-treatment nursing assessment, as indicated. Interview revealed nursing staff should evaluate the patient and respond to the condition accordingly. Interview revealed If abnormal findings are reported to the nurse, there should be a follow up evaluation of the patient’s condition and documentation should occur. Interview revealed the facility nursing staff failed to document abnormal findings per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that patients experiencing high or low blood pressures as defined by facility policy should be reported to the nurse for follow up evaluation of the patient’s pre-treatment medication regimen, if indicated, such that adjustments could be made, if needed. Interview revealed the patient care staff failed to follow policy. b. Medical record review on 01/30/2024 for Patient #5 revealed a 51-year-old male was admitted for In-Center Hemodialysis treatments on 08/18/2020. Review of the Treatment Flowsheet on 01/16/2024 revealed the patient dialyzed from 0713-1159 (4 hours, 46 minutes). The documented blood pressure at 0918 was 181/100 and 204/93 at 0949. Review of the Post-treatment nursing assessment revealed, “No unusual findings noted.” Review of the nursing assessment revealed no documented nursing assessment of the patient’s elevated blood pressure readings during hemodialysis. Review of the Treatment Flowsheet for 01/18/2024 revealed the patient dialyzed from 0805-1300 (4 hours, 55 minutes). The documented blood pressure at 0805 was 180/100 and 177/101 at 0836. At 0930, the blood pressure was documented as 195/115, 197/108 at 1000, 175/111 at 1030, 191/111 at 1100, and 177/103 at 1130. Review of the Post-treatment nursing assessment revealed, “Tx completed with no issues, assessment unchanged from this morning; spoke to patient about running full tx and not skipping txs so we can get him to his goals; left tx floor stable.” Review of the nursing assessment revealed no documented nursing assessment of the patient’s elevated blood pressure readings during hemodialysis. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed abnormal findings should be documented by the nurse either during the hemodialysis treatment or in the pre- or post-treatment nursing assessment, as indicated. Interview revealed nursing staff should evaluate the patient and respond to the condition accordingly. Interview revealed If abnormal findings are reported to the nurse, there should be a follow up evaluation of the patient’s condition and documentation should occur. Interview revealed the facility nursing staff failed to document abnormal findings per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that patients experiencing high or low blood pressures as defined by facility policy should be reported to the nurse for follow up evaluation of the patient’s pre-treatment medication regimen, if indicated, such that adjustments could be made, if needed. Interview revealed the patient care staff failed to follow policy. c. Medical record review on 01/30/2024 for Patient #6 revealed an 81-year-old male was admitted for In-Center Hemodialysis treatments on 03/22/2012. Review of the Treatment Flowsheet for 01/18/2024 revealed the patient dialyzed from 0625-0936 (3 hours, 11 minutes). At 0859, the blood pressure was documented as 87/57 with documentation by the PCT stating, “rechecking bp/rn [blood pressure/registered nurse] aware.” Further review of the Treatment Flowsheet revealed at 0931, the blood pressure was documented as 87/39 and 96/51 at 0939 with documentation by the PCT stating “...ended tx [treatment] 13 mins [minutes] early d/t [due to] bp dropping.” Review of the post-treatment nursing assessment revealed, “... RN Evaluation - No unusual findings noted. Tx. completed w/o [without] incident. No issues noted during tx... VSS [Vital Signs Stable]. Pt voiced no c/o [complaint of] or concerns at discharge... Pt tx time adj [adjusted] per pt request.” Review revealed no documented nursing assessment of the patient’s blood pressure readings during treatment. Review of the Treatment Flowsheet for 01/20/2024 revealed the patient dialyzed from 0638-0946 (3 hours, 8 minutes). The documented blood pressure at 0900 was 97/56 and 106/48 at 0924 with documentation by the PCT stating, “PT BP low, 200cc [measurement of volume] given, RN notified.” Review of the post-treatment nursing assessment revealed, “...Tx completed w/o incident. No issues noted during tx...” Review revealed no documented nursing assessment or follow up of the patient’s low blood pressure readings during hemodialysis. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed abnormal findings should be documented by the nurse either during the hemodialysis treatment or in the pre- or post-treatment nursing assessment, as indicated. Interview revealed nursing staff should evaluate the patient and respond to the condition accordingly. Interview revealed If abnormal findings are reported to the nurse, there should be a follow up evaluation of the patient’s condition and documentation should occur. Interview revealed the facility nursing staff failed to document abnormal findings per policy. Interview on 01/31/2024 at 1420 with the Medical Director revealed that patients experiencing high or low blood pressures as defined by facility policy should be reported to the nurse for follow up evaluation of the patient’s pre-treatment medication regimen, if indicated, such that adjustments could be made, if needed. Interview revealed the patient care staff failed to follow policy. 6. Review on 01/31/2024 of the facility policy titled, “Medication Preparation and Administration” Published: 02/06/2023, revealed, “... The following points must be followed to ensure proper documentation of medication preparation and administration. Medication administration must be documented in the patient’s medical records... Document reason for PRN [as needed] drug administration and effectiveness of medication post administration in the patient’s medical record.” Medical record review on 01/30/2024 for Patient #5 revealed a 51-year-old male was admitted for In-Center Hemodialysis treatments on 08/18/2020. Review of the physician ordered “Treatment Medications” revealed Clonidine HCL [used to treat high blood pressure] 0.1mg ORAL during dialysis prn [as needed’ - may repeat x1 SBP >190/DBP >100 was ordered on 05/25/2023 with a stop date of 05/23/2024. Review of the Treatment Flowsheet for 01/18/2024 revealed the patient dialyzed from 0805-1300 (4 hours, 55 minutes). The documented blood pressure at 0805 was 180/100 and 177/101 at 0836. At 0930, the blood pressure was documented as 195/115, 197/108 at 1000, 175/111 at 1030, 191/111 at 1100, and 177/103 at 1130. Review of the medications administered during the patient’s hemodialysis treatment revealed the nurse was at the patient’s chairside and administered scheduled Sensipar [used to treat high parathyroidism] 30mg at 1100; however, the Clonidine prn was not administered per the physician order. Interview on 01/31/2024 at 1355 with the Facility Administrator revealed prn Clonidine should be administered as ordered. Interview revealed the nurse is responsible for monitoring the patient and for administering medications as ordered. Interview revealed the nurse staff failed to administer prn Clonidine as ordered.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 35306 Based on policy review, medical record review and staff interview, the facility’s patient care staff failed to dialyze a hemodialysis patient according to a physician ordered dialysis prescription for 5 of 10 sampled patient treatment flowsheets reviewed (Patients #1, #2, #5, #6, and #7). Findings included: Review on 01/31/2024 of the facility policy titled “Patient Assessment and Monitoring” Published: 05/01/2023, revealed, “ ... During Treatment ... Follow the steps below for monitoring patient and machine parameters during treatment ... 3. Machine Parameters ... Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow ...” 1. Medical record review on 01/29/2024 for Patient #1 revealed the patient was admitted to the facility on 10/09/2017 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/24/2024 revealed the patient had a BFR of “350” ordered by the physician. Review of treatment flowsheets from 01/15/2024 to 01/26/2024 revealed the facility patient care staff failed to dialyze the patient at the prescribed BFR on 01/26/2024 when Patient #1 was dialyzed from 0758-1019 with a BFR of “300” (50 less than the prescribed rate). The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered BFR. No physician order was found in the medical record to indicate the patient’s physician was aware of the BFR changes. Interview on 01/31/2024 at 1355 with the FA revealed that if the patient is unable to obtain the prescribed BFR, the treatment flowsheet should include documentation from staff indicating the reason the prescribed order was not followed. Interview on 01/31/2024 at 1420 with the MD revealed that his expectation was that staff follow the prescribed orders for patients and that if the patient is unable to reach the prescribed BFR, there should be documentation available supporting the need to deviate from the patient’s prescription. 2. Medical record review on 01/29/2024 for Patient #2 revealed the patient was admitted to the facility on 01/05/2017 for ICHD treatment. The review of the patient’s dialysis prescription dated 12/27/2023 revealed the patient had a BFR of “350” ordered by the physician. Review of treatment flowsheets from 01/15/2024 to 01/26/2024 revealed the facility patient care staff failed to dialyze the patient at the prescribed BFR on 01/22/2024 when Patient #2 dialyzed from 1057-1500 with a BFR of “300” (50 less than the prescribed rate). The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered BFR. No physician order was found in the medical record to indicate the patient’s physician was aware of the BFR changes. Interview on 01/31/2024 at 1355 with the FA revealed that if the patient is unable to obtain the prescribed BFR, the treatment flowsheet should include documentation from staff indicating the reason the prescribed order was not followed. Interview on 01/31/2024 at 1420 with the MD revealed that his expectation was that staff follow the prescribed orders for patients and that if the patient is unable to reach the prescribed BFR, there should be documentation available supporting the need to deviate from the patient’s prescription. 3. Medical record review on 01/29/2024 for Patient #5 revealed the patient was admitted to the facility on 08/18/2020 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/16/2024 revealed the patient had a BFR of “450” ordered by the physician. Review of treatment flowsheets from 01/16/2024 to 01/27/2024 revealed the facility patient care staff failed to dialyze the patient at the prescribed BFR on 01/16/2024 when Patient #5 dialyzed from 0826-1159 with a BFR of “400” (50 less than the prescribed rate); 01/18/2024 from 0805-1001 with a BFR of “400” (50 less than the prescribed rate) and from 1038-1234 with a BFR of “420” (30 less than the prescribed rate); and on 01/20/2024 from 0702-1102 with a BFR of “400” (50 less than the prescribed rate). The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered BFR. No physician order was found in the medical record to indicate the patient’s physician was aware of the BFR changes. Interview on 01/31/2024 at 1355 with the FA revealed that if the patient is unable to obtain the prescribed BFR, the treatment flowsheet should include documentation from staff indicating the reason the prescribed order was not followed. Interview on 01/31/2024 at 1420 with the MD revealed that his expectation was that staff follow the prescribed orders for patients and that if the patient is unable to reach the prescribed BFR, there should be documentation available supporting the need to deviate from the patient’s prescription. 4. Medical record review on 01/30/2024 for Patient #6 revealed the patient was admitted to the facility on 03/22/2012 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/16/2024 revealed the patient had a BFR of “450” ordered by the physician. Review of treatment flowsheets from 01/16/2024 to 01/27/2024 revealed on 01/27/2024, Patient #6 dialyzed from 0802-0939 with a BFR of “300” (150 less than the prescribed rate). The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered BFR. No physician order was found in the medical record to indicate the patient’s physician was aware of the BFR changes. Interview on 01/31/2024 at 1355 with the FA revealed that if the patient is unable to obtain the prescribed BFR, the treatment flowsheet should include documentation from staff indicating the reason the prescribed order was not followed. Interview on 01/31/2024 at 1420 with the MD revealed that his expectation was that staff follow the prescribed orders for patients and that if the patient is unable to reach the prescribed BFR, there should be documentation available supporting the need to deviate from the patient’s prescription. 5. Medical record review on 01/30/2024 for Patient #7 revealed the patient was admitted to the facility on 04/29/2014 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/15/2024 revealed the patient had a BFR of “450” ordered by the physician. Review of treatment flowsheets from 01/15/2024 to 01/26/2024 revealed that on 01/15/2024, Patient #7 dialyzed from 1449-1630 with a BFR of “300” (150 less than the prescribed rate) and from 1700-1751 with a BFR of “400” (100 less than the prescribed rate). The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered BFR. No physician order was found in the medical record to indicate the patient’s physician was aware of the BFR changes. Interview on 01/31/2024 at 1355 with the FA revealed that if the patient is unable to obtain the prescribed BFR, the treatment flowsheet should include documentation from staff indicating the reason the prescribed order was not followed. Interview on 01/31/2024 at 1420 with the MD revealed that his expectation was that staff follow the prescribed orders for patients and that if the patient is unable to reach the prescribed BFR, there should be documentation available supporting the need to deviate from the patient’s prescription.”

“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: 35306 Based on policy review, medical record review and staff interview, the facility’s medical director failed to assure facility staff adhered to policy and procedures for prescription verification of machine temperatures for 5 of 10 sampled patients (Patients #1, #3, #4, #5, and #6). Findings included: Review on 01/31/2024 of the facility policy titled, “Nursing Supervision and Delegation” Published: 11/06/2023, revealed, “ ... Policy The registered nurse must evaluate each patient preferable within an hour or according to state requirements .... Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed ...” 1. Medical record review on 01/29/2024 for Patient #1 revealed the patient was admitted to the facility on 01/05/2017 for ICHD treatment. The review of the patient’s dialysis prescription dated 12/27/2023 revealed the patient had a Machine Temperature of “36.5” degrees Celsius ordered by the physician. Review of treatment flowsheets from 01/15/2024 to 01/26/2024 revealed the facility patient care staff documented the machine temperature as “37.0”, 0.5 degrees higher than the prescribed temperature, on 01/15/2024, 01/17/2024, 01/22/2024, and 01/24/2024 with “MACHINE SETUP ...REVIEWED BY” documented by the RN on each of the treatment flowsheets reviewed. The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not set the machine up with the prescribed machine temperature. No physician order was found in the medical record to indicate the patient’s physician was aware of the machine temperature changes. Interview on 01/25/2024 at 1645 with the MD revealed that he was not aware machine temperatures were not being programmed and/or documented as prescribed and that his expectation was that staff follow the prescribed orders for patients. 2. Medical record review on 01/29/2024 for Patient #3 revealed the patient was admitted to the facility on 10/16/2015 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/19/2024 revealed the patient had a Machine Temperature of “36.0” degrees Celsius ordered by the physician. Review of treatment flowsheets from 01/15/2024 to 01/26/2024 revealed the facility patient care staff documented the machine temperature as “37.0”, 1.0 degree higher, on 01/15/2024; “35.9”, 0.1 degree less on 01/19/2024 and 01/22/2024; and “35.2”, 0.8 degrees less than the prescribed temperature on 01/26/2024, with “MACHINE SETUP ...REVIEWED BY” documented by the RN on each of the treatment flowsheets reviewed. The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered Dialysate temperature. No physician order was found in the medical record to indicate the patient’s physician was aware of the Dialysate temperature changes. Interview on 01/25/2024 at 1645 with the MD revealed that he was not aware machine temperatures were not being programmed and/or documented as prescribed and that his expectation was that staff follow the prescribed orders for patients. 3. Medical record review on 01/29/2024 for Patient #4 revealed the patient was admitted to the facility on 09/23/2023 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/19/2024 revealed the patient had a Dialysate temperature of “37.0” degrees Celsius ordered by the physician. Review of treatment flowsheets from 01/15/2024 to 01/26/2024 revealed the facility patient care staff documented the machine temperature as “36.0”, 1.0 degree less than the prescribed temperature on 01/19/2024, with “MACHINE SETUP ...REVIEWED BY” documented by the RN on each of the treatment flowsheets reviewed. The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered Dialysate temperature. No physician order was found in the medical record to indicate the patient’s physician was aware of the Dialysate temperature changes. Interview on 01/25/2024 at 1645 with the MD revealed that he was not aware machine temperatures were not being programmed and/or documented as prescribed and that his expectation was that staff follow the prescribed orders for patients. 4. Medical record review on 01/30/2024 for Patient #5 revealed the patient was admitted to the facility on 08/18/2020 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/16/2024 revealed the patient had a Dialysate temperature of “37.0” degrees Celsius ordered by the physician. Review of treatment flowsheets from 01/16/2024 to 01/27/2024 revealed the facility patient care staff documented “35.7”, 1.3 degrees less than the prescribed temperature on 01/16/2024, with “MACHINE SETUP ...REVIEWED BY” documented by the RN on each of the treatment flowsheets reviewed. The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered Dialysate temperature. No physician order was found in the medical record to indicate the patient’s physician was aware of the Dialysate temperature changes. Interview on 01/25/2024 at 1645 with the MD revealed that he was not aware machine temperatures were not being programmed and/or documented as prescribed and that his expectation was that staff follow the prescribed orders for patients. 5. Medical record review on 01/30/2024 for Patient #6 revealed the patient was admitted to the facility on 03/22/2012 for ICHD treatment. The review of the patient’s dialysis prescription dated 01/16/2024 revealed the patient had a Dialysate temperature of “37.0” degrees Celsius ordered by the physician. Review of treatment flowsheets from 01/16/2024 to 01/27/2024 revealed the facility patient care staff documented “36.5”, 0.5 degrees less than the prescribed temperature on 01/23/2024, with “MACHINE SETUP ...REVIEWED BY” documented by the RN on each of the treatment flowsheets reviewed. The review in the clinical record revealed no documented complications or issues for the reason the facility staff did not dialyze the patient at the ordered Dialysate temperature. No physician order was found in the medical record to indicate the patient’s physician was aware of the Dialysate temperature changes. Interview on 01/25/2024 at 1645 with the MD revealed that he was not aware machine temperatures were not being programmed and/or documented as prescribed and that his expectation was that staff follow the prescribed orders for patients.”

“GOV-GB INFORMS MED STAFF OF P&P/QAPI PROG CFR(s): 494.180(c)(2),(3) The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. This Standard is not met as evidenced by: 32003 Based on medical staff bylaws, policy reviews, QAPI review, medical record reviews, and staff interviews revealed the Governing Body failed to ensure an iron protocol utilized by [Nephrologist #1] was approved for patient use for 7 of 8 patients (#12, #13, #14, #15, #16, #17, and #18). Findings included: Review on January 31, 2024 of the facility’s “MEDICAL STAFF BYLAWS” revised May 23, 2011 revealed, “ARTICLE I - NAME ...ARTICLE II - DEFINITIONS ...ARTICLE III - PURPOSES ...ARTICLE IV - ORGANIZATION OF MEDICAL STAFF ...4.1 CHAIRPERSON ...4.3.2 Duties ...The Medical Director is responsible for the delivery of patient and outcomes in the Facility and is accountable to the Company, [organization] Medical Department, Governing Body, and CMS, for the quality of medical care provided to patients. Medical Director responsibilities include, but are not limited to, the following: a. ...d. Oversight of all Medical Staff Members and their compliance with these Bylaws and Policies and Procedures. ...” Review on January 31, 2024 of the facility’s “Special Considerations: Mircera” published September 5, 2023 revealed there was no iron protocol utilized by [Nephrologist #1] attached as an addendum for patient use. Review on January 31, 2024 of the facility’s “Mircera IVP Administration Anemia Algorithm” revised January 1, 2023 revealed there was no iron protocol utilized by [Nephrologist #1] attached as an addendum for patient use. Review on January 30, 2024 at the QAPI clinical outcomes revealed, the percentage of patients at the facility with a hemoglobin less than 10 included 7 of 8 patients under the care of [Nephrologist #1]. Review on January 30, 2024 of the Governing Body meeting minutes from April 24, 2019 through January 24, 2024 failed to reveal approval of an iron protocol utilized by [Nephrologist #1]. 1. Open medical record review on January 31, 2024 revealed Patient #12 was admitted to the in-center facility in August 2022 and was under the care of [Nephrologist #1]. Review from November 9, 2023 through January 27, 2024 revealed, a.) hemoglobin levels ranged from 7.8 to 9.8 g/dl, b.) Ferritin levels ranged from 511 to 853 ng/ml, c.) TSAT levels ranged from 15 to 20, and d.) 100 mg of iron sucrose was administered fourteen times. Review revealed the patient was administered iron sucrose via an unapproved protocol. Interview on January 30, 2024 at about 9:30 AM with the Clinical Nurse Manager revealed, [Nephrologist #1] utilized an iron protocol algorithm that if: a.) Ferritin <800 and TSAT < 30 = six (6) doses of iron), b.) Ferritin <800 and TSAT between 30 - 50 = 100 doses of iron per week, and c.) Ferritin >800 = no doses of iron. Interview revealed there was not tangible copy of the iron protocol utilized by [Nephrologist #1]. Telephone interview on January 30, 2024 at 3:08 PM with [Nephrologist #1] revealed, the doctor provided patient care at the facility for more than 10-years, in which, the iron protocol had been in effect for patient care for many years. Interview revealed, the iron protocol was utilized because the doctor refused to use the anemia algorithm utilized by [organization] and the surveyor should follow-up with the Governing Body for approval of the protocol. Telephone interview on January 30, 2024 at 3:42 PM with the Medical Director revealed, as to knowing [Nephrologist #1] for 25-years and some of that time was from [Nephrology Group] where [Nephrologist #1] was formerly employed. The medical director’s last conversation with [Nephrologist #1] occurred about eight (8) days ago. Additionally, the Governing Body recently discussed [Nephrologist #1] on January 22, 2024. Interview revealed: 1.) the iron protocol utilized by [Nephrologist #1] has not been presented to the Governing Body for approval, 2.) [Nephrologist #1 becomes upset with any mentioning of the iron protocol, and 3.) hemoglobin levels were suboptimal for the patients subjected to the iron protocol. Interview revealed [Nephrologist #1] was a good doctor that cared for the patients under his/her care, but there were some areas of improvements that were needed, wherein, the medical director planned to present the iron protocol to the Governing Body for review because he/she was responsible for the care of the patients at the dialysis facility. Interview on January 31, 2024 at 9:15 AM with [Nephrologist #1] revealed, the nephrologist provided a rounding book for when he/she was at the facility. Additionally, the nephrologist revealed, that historically had a patient in the hospital received intravenous iron and developed iron deposits on the brain as a rational for not utilizing the [organization] iron protocol. 2. Open medical record review on January 31, 2024 revealed, Patient #13 was admitted to the in-center facility in July 2023 and was under the care of [Nephrologist #1]. Review from November 4, 2023 through January 25, 2024 revealed, a.) hemoglobin levels ranged from 8.3 to 9.8 g/dl, b.) Ferritin levels ranged from 390 to 1230 ng/ml, c.) TSAT levels were 27 and 28 percent, and d.) 100 mg of iron sucrose was administered nine times and 50 mg was administered once. Review revealed the patient was administered iron sucrose via an unapproved protocol. Interview on January 30, 2024 at about 9:30 AM with the Clinical Nurse Manager revealed, [Nephrologist #1] utilized an iron protocol algorithm that if: a.) Ferritin <800 and TSAT < 30 = six (6) doses of iron), b.) Ferritin <800 and TSAT between 30 - 50 = 100 doses of iron per week, and c.) Ferritin >800 = no doses of iron. Interview revealed there was not tangible copy of the iron protocol utilized by [Nephrologist #1]. Telephone interview on January 30, 2024 at 3:08 PM with [Nephrologist #1] revealed, the doctor provided patient care at the facility for more than 10-years, in which, the iron protocol had been in effect for patient care for many years. Interview revealed, the iron protocol was utilized because the doctor refused to use the anemia algorithm utilized by [organization] and the surveyor should follow-up with the Governing Body for approval of the protocol. Telephone interview on January 30, 2024 at 3:42 PM with the Medical Director revealed, as to knowing [Nephrologist #1] for 25-years and some of that time was from [Nephrology Group] where [Nephrologist #1] was formerly employed. The medical director’s last conversation with [Nephrologist #1] occurred about eight (8) days ago. Additionally, the Governing Body recently discussed [Nephrologist #1] on January 22, 2024. Interview revealed: 1.) the iron protocol utilized by [Nephrologist #1] has not been presented to the Governing Body for approval, 2.) [Nephrologist #1 becomes upset with any mentioning of the iron protocol, and 3.) hemoglobin levels were suboptimal for the patients subjected to the iron protocol. Interview revealed [Nephrologist #1] was a good doctor that cared for the patients under his/her care, but there were some areas of improvements that were needed, wherein, the medical director planned to present the iron protocol to the Governing Body for review because he/she was responsible for the care of the patients at the dialysis facility. Interview on January 31, 2024 at 9:15 AM with [Nephrologist #1] revealed, the nephrologist provided a rounding book for when he/she was at the facility. Additionally, the nephrologist revealed, that historically had a patient in the hospital received intravenous iron and developed iron deposits on the brain as a rational for not utilizing the [organization] iron protocol. 3. Open medical record review on January 31, 2024 revealed, Patient #14 was admitted to the in-center facility in August 2022 and was under the care of [Nephrologist #1]. Review from November 8, 2023 through January 26, 2024 revealed, a.) hemoglobin levels ranged from 7.4 to 10.0 g/dl, b.) Ferritin levels ranged from 415 to 922 ng/ml, c.) TSAT levels ranged from 22 to 39 percent, and d.) 100 mg of iron sucrose was administered eleven times. Review revealed the patient was administered iron sucrose via an unapproved protocol. Interview on January 30, 2024 at about 9:30 AM with the Clinical Nurse Manager revealed, [Nephrologist #1] utilized an iron protocol algorithm that if: a.) Ferritin <800 and TSAT < 30 = six (6) doses of iron), b.) Ferritin <800 and TSAT between 30 - 50 = 100 doses of iron per week, and c.) Ferritin >800 = no doses of iron. Interview revealed there was not tangible copy of the iron protocol utilized by [Nephrologist #1]. Telephone interview on January 30, 2024 at 3:08 PM with [Nephrologist #1] revealed, the doctor provided patient care at the facility for more than 10-years, in which, the iron protocol had been in effect for patient care for many years. Interview revealed, the iron protocol was utilized because the doctor refused to use the anemia algorithm utilized by [organization] and the surveyor should follow-up with the Governing Body for approval of the protocol. Telephone interview on January 30, 2024 at 3:42 PM with the Medical Director revealed, as to knowing [Nephrologist #1] for 25-years and some of that time was from [Nephrology Group] where [Nephrologist #1] was formerly employed. The medical director’s last conversation with [Nephrologist #1] occurred about eight (8) days ago. Additionally, the Governing Body recently discussed [Nephrologist #1] on January 22, 2024. Interview revealed: 1.) the iron protocol utilized by [Nephrologist #1] has not been presented to the Governing Body for approval, 2.) [Nephrologist #1 becomes upset with any mentioning of the iron protocol, and 3.) hemoglobin levels were suboptimal for the patients subjected to the iron protocol. Interview revealed [Nephrologist #1] was a good doctor that cared for the patients under his/her care, but there were some areas of improvements that were needed, wherein, the medical director planned to present the iron protocol to the Governing Body for review because he/she was responsible for the care of the patients at the dialysis facility. Interview on January 31, 2024 at 9:15 AM with [Nephrologist #1] revealed, the nephrologist provided a rounding book for when he/she was at the facility. Additionally, the nephrologist revealed, that historically had a patient in the hospital received intravenous iron and developed iron deposits on the brain as a rational for not utilizing the [organization] iron protocol. 4. Open medical record review on January 31, 2024 revealed, Patient #15 was admitted to the in-center facility in December 2019 and was under the care of [Nephrologist #1]. Review from November 13, 2024 through January 24, 2024 revealed, a.) hemoglobin levels ranged from 8.5 to 9.9 g/dl, b.) Ferritin levels ranged from 800 to 1400 ng/ml, c.) TSAT levels were 16 and 41 percent, and d.) 100 mg of iron sucrose was administered nine times. Review revealed the patient was administered iron sucrose via an unapproved protocol. Interview on January 30, 2024 at about 9:30 AM with the Clinical Nurse Manager revealed, [Nephrologist #1] utilized an iron protocol algorithm that if: a.) Ferritin <800 and TSAT < 30 = six (6) doses of iron), b.) Ferritin <800 and TSAT between 30 - 50 = 100 doses of iron per week, and c.) Ferritin >800 = no doses of iron. Interview revealed there was not tangible copy of the iron protocol utilized by [Nephrologist #1]. Telephone interview on January 30, 2024 at 3:08 PM with [Nephrologist #1] revealed, the doctor provided patient care at the facility for more than 10-years, in which, the iron protocol had been in effect for patient care for many years. Interview revealed, the iron protocol was utilized because the doctor refused to use the anemia algorithm utilized by [organization] and the surveyor should follow-up with the Governing Body for approval of the protocol. Telephone interview on January 30, 2024 at 3:42 PM with the Medical Director revealed, as to knowing [Nephrologist #1] for 25-years and some of that time was from [Nephrology Group] where [Nephrologist #1] was formerly employed. The medical director’s last conversation with [Nephrologist #1] occurred about eight (8) days ago. Additionally, the Governing Body recently discussed [Nephrologist #1] on January 22, 2024. Interview revealed: 1.) the iron protocol utilized by [Nephrologist #1] has not been presented to the Governing Body for approval, 2.) [Nephrologist #1 becomes upset with any mentioning of the iron protocol, and 3.) hemoglobin levels were suboptimal for the patients subjected to the iron protocol. Interview revealed [Nephrologist #1] was a good doctor that cared for the patients under his/her care, but there were some areas of improvements that were needed, wherein, the medical director planned to present the iron protocol to the Governing Body for review because he/she was responsible for the care of the patients at the dialysis facility. Interview on January 31, 2024 at 9:15 AM with [Nephrologist #1] revealed, the nephrologist provided a rounding book for when he/she was at the facility. Additionally, the nephrologist revealed, that historically had a patient in the hospital received intravenous iron and developed iron deposits on the brain as a rational for not utilizing the [organization] iron protocol. 5. Open medical record review on January 31, 2024 revealed, Patient #16 was admitted to the in-center facility in November 2022 and was under the care of [Nephrologist #1]. Review from November 8, 2024 through January 26, 2024 revealed, a.) hemoglobin levels ranged from 9.4 to 12.3 g/dl, b.) Ferritin levels ranged from 226 to 310 ng/ml, c.) TSAT levels ranged from 16 to 41 percent, and d.) 100 mg of iron sucrose was administered six times. Review revealed the patient was administered iron sucrose via an unapproved protocol. Interview on January 30, 2024 at about 9:30 AM with the Clinical Nurse Manager revealed, [Nephrologist #1] utilized an iron protocol algorithm that if: a.) Ferritin <800 and TSAT < 30 = six (6) doses of iron), b.) Ferritin <800 and TSAT between 30 - 50 = 100 doses of iron per week, and c.) Ferritin >800 = no doses of iron. Interview revealed there was not tangible copy of the iron protocol utilized by [Nephrologist #1]. Telephone interview on January 30, 2024 at 3:08 PM with [Nephrologist #1] revealed, the doctor provided patient care at the facility for more than 10-years, in which, the iron protocol had been in effect for patient care for many years. Interview revealed, the iron protocol was utilized because the doctor refused to use the anemia algorithm utilized by [organization] and the surveyor should follow-up with the Governing Body for approval of the protocol. Telephone interview on January 30, 2024 at 3:42 PM with the Medical Director revealed, as to knowing [Nephrologist #1] for 25-years and some of that time was from [Nephrology Group] where [Nephrologist #1] was formerly employed. The medical director’s last conversation with [Nephrologist #1] occurred about eight (8) days ago. Additionally, the Governing Body recently discussed [Nephrologist #1] on January 22, 2024. Interview revealed: 1.) the iron protocol utilized by [Nephrologist #1] has not been presented to the Governing Body for approval, 2.) [Nephrologist #1 becomes upset with any mentioning of the iron protocol, and 3.) hemoglobin levels were suboptimal for the patients subjected to the iron protocol. Interview revealed [Nephrologist #1] was a good doctor that cared for the patients under his/her care, but there were some areas of improvements that were needed, wherein, the medical director planned to present the iron protocol to the Governing Body for review because he/she was responsible for the care of the patients at the dialysis facility. Interview on January 31, 2024 at 9:15 AM with [Nephrologist #1] revealed, the nephrologist provided a rounding book for when he/she was at the facility. Additionally, the nephrologist revealed, that historically had a patient in the hospital received intravenous iron and developed iron deposits on the brain as a rational for not utilizing the [organization] iron protocol. 6. Open medical record review on January 31, 2024 revealed, Patient #17 was admitted to the in-center facility in January 2021 and was under the care of [Nephrologist #1]. Review from November 7, 2023 through January 25, 2024 revealed, a.) hemoglobin levels ranged from 6.9 to 10.2 g/dl, b.) Ferritin levels ranged from 598 to 870 ng/ml, c.) TSAT levels were 33, 34, and 49 percent, and d.) 100 mg of iron sucrose was administered nine times. Review revealed the patient was administered iron sucrose via an unapproved protocol. Interview on January 30, 2024 at about 9:30 AM with the Clinical Nurse Manager revealed, [Nephrologist #1] utilized an iron protocol algorithm that if: a.) Ferritin <800 and TSAT < 30 = six (6) doses of iron), b.) Ferritin <800 and TSAT between 30 - 50 = 100 doses of iron per week, and c.) Ferritin >800 = no doses of iron. Interview revealed there was not tangible copy of the iron protocol utilized by [Nephrologist #1]. Telephone interview on January 30, 2024 at 3:08 PM with [Nephrologist #1] revealed, the doctor provided patient care at the facility for more than 10-years, in which, the iron protocol had been in effect for patient care for many years. Interview revealed, the iron protocol was utilized because the doctor refused to use the anemia algorithm utilized by [organization] and the surveyor should follow-up with the Governing Body for approval of the protocol. Telephone interview on January 30, 2024 at 3:42 PM with the Medical Director revealed, as to knowing [Nephrologist #1] for 25-years and some of that time was from [Nephrology Group] where [Nephrologist #1] was formerly employed. The medical director’s last conversation with [Nephrologist #1] occurred about eight (8) days ago. Additionally, the Governing Body recently discussed [Nephrologist #1] on January 22, 2024. Interview revealed: 1.) the iron protocol utilized by [Nephrologist #1] has not been presented to the Governing Body for approval, 2.) [Nephrologist #1 becomes upset with any mentioning of the iron protocol, and 3.) hemoglobin levels were suboptimal for the patients subjected to the iron protocol. Interview revealed [Nephrologist #1] was a good doctor that cared for the patients under his/her care, but there were some areas of improvements that were needed, wherein, the medical director planned to present the iron protocol to the Governing Body for review because he/she was responsible for the care of the patients at the dialysis facility. Interview on January 31, 2024 at 9:15 AM with [Nephrologist #1] revealed, the nephrologist provided a rounding book for when he/she was at the facility. Additionally, the nephrologist revealed, that historically had a patient in the hospital received intravenous iron and developed iron deposits on the brain as a rational for not utilizing the [organization] iron protocol. 7. Open medical review on January 31, 2024 revealed, Patient #18 was admitted to the in-center facility in April 2022 and was under the care of [Nephrologist #1]. Review from November 8, 2023 through January 29, 2024 revealed, a.) hemoglobin levels ranged from 8.6 to 9.7 g/dl, b.) Ferritin levels ranged from 358 to 634 ng/ml, c.) TSAT levels were 5, 11, and 16 percent, and d.) 100 mg of iron sucrose was administered fifteen times. Review revealed the patient was administered iron sucrose via an unapproved protocol. Interview on January 30, 2024 at about 9:30 AM with the Clinical Nurse Manager revealed, [Nephrologist #1] utilized an iron protocol algorithm that if: a.) Ferritin <800 and TSAT < 30 = six (6) doses of iron), b.) Ferritin <800 and TSAT between 30 - 50 = 100 doses of iron per week, and c.) Ferritin >800 = no doses of iron. Interview revealed there was not tangible copy of the iron protocol utilized by [Nephrologist #1]. Telephone interview on January 30, 2024 at 3:08 PM with [Nephrologist #1] revealed, the doctor provided patient care at the facility for more than 10-years, in which, the iron protocol had been in effect for patient care for many years. Interview revealed, the iron protocol was utilized because the doctor refused to use the anemia algorithm utilized by [organization] and the surveyor should follow-up with the Governing Body for approval of the protocol. Telephone interview on January 30, 2024 at 3:42 PM with the Medical Director revealed, as to knowing [Nephrologist #1] for 25-years and some of that time was from [Nephrology Group] where [Nephrologist #1] was formerly employed. The medical director’s last conversation with [Nephrologist #1] occurred about eight (8) days ago. Additionally, the Governing Body recently discussed [Nephrologist #1] on January 22, 2024. Interview revealed: 1.) the iron protocol utilized by [Nephrologist #1] has not been presented to the Governing Body for approval, 2.) [Nephrologist #1 becomes upset with any mentioning of the iron protocol, and 3.) hemoglobin levels were suboptimal for the patients subjected to the iron protocol. Interview revealed [Nephrologist #1] was a good doctor that cared for the patients under his/her care, but there were some areas of improvements that were needed, wherein, the medical director planned to present the iron protocol to the Governing Body for review because he/she was responsible for the care of the patients at the dialysis facility. Interview on January 31, 2024 at 9:15 AM with [Nephrologist #1] revealed, the nephrologist provided a rounding book for when he/she was at the facility. Additionally, the nephrologist revealed, that historically had a patient in the hospital received intravenous iron and developed iron deposits on the brain as a rational for not utilizing the [organization] iron protocol. NC00208951”