Fresenius Medical Care Loganville

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 03383 Based on a review of medical records and facility policy and employee interview, it was determined that the medical director failed to ensure that staff adhered to facility policy pertaining to hypertension [elevated blood pressure (BP)] to ensure that one of two patients (P#2) sampled who experienced extremely high BP readings before, during, and after dialysis treatment, received medical care/interventions appropriate to the patient’s needs. This failure resulted in P#2’s hospitalization and could negatively affect the health and safety of the other 41 patients who were dialyzing at this facility. Findings were: Cross Reference V715 - Failure of the medical director to ensure that staff adhered to facility policy pertaining to hypertension.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure the facility’s Emergency Preparedness Plan (EPP) was evaluated and updated at least every 2 years. The facility census was 42. Findings were: A review of the facility’s EPP with the Facility Administrator (FA) on 12/29/23 at 10:53 a.m., revealed the FA could not provide documentation to confirm the emergency preparedness plan was evaluated and updated at least every 2 years.”

“Information on Occupancy/Needs CFR(s): §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure that the facility’s Emergency Preparedness Plan (EPP) included a means of providing information about the facility’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. The facility census was 42. Findings were: A review of the facility’s EPP with the Facility Administrator (FA) on 12/21/23 at 1:50 p.m., revealed that the FA could not provide documentation to confirm that the EPP included a means of providing information about the facility’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 03383 Based on observation, a review of CDC recommendations, staff interview and review of facility policy, it was determined that the Infection Control Committee failed to ensure that one of one Patient Care Technician (PCT CC) observed, performed hand hygiene (wash hands with soap and water or use an alcohol based hand sanitizer) after glove removal. This deficient practice had the potential for cross contamination and increased risk of infection and could affect 42 patients who were dialyzing at this facility. Findings were: During observation in the patient treatment room on 12/27/23 between 1:08 p.m. and 1:45 p.m., the following was observed: - PCT CC performed tasks at Station (S) 10 with gloved hands. When finished, she removed the gloves and without performing hand hygiene, donned a new pair of gloves, went over to S12 and touched buttons on the machine at S12. - PCT CC then proceeded to S11, touched the machine, removed gloves and without performing hand hygiene, donned a new pair of gloves. - This deficient practice was again repeated at S13. - PCT CC also obtained gauze, dipped gauze in cleaning solution, placed gauze pad on top of the machine at S10, removed gloves and donned a new pair of gloves. - PCT CC then proceeded to S5, touched the machine, removed gloves and washed her hands at this point. According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. The Facility Administrator was informed about the above observations on 12/27/23 at 2:45 p.m. and provided a copy of the facility’s hand hygiene policy per surveyor’s request. A review of Policy titled, “Hand Hygiene” dated 11/06/23 showed the following: Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water. Immediately after removing gloves.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 03383 Based on observation and staff interviews, it was determined that the facility failed to ensure that four of nine patients observed in the patient treatment area at Stations (S) 1, 2, 5 and 9, had their vascular access sites uncovered/visible to the staff throughout dialysis treatment, to ensure patient safety. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood). The facility census was 42. Findings were: An observation in the patient treatment area on 12/29/23 between 7:37 a.m. and 7:42 a.m., revealed three patients who were dialyzing in S2, S5, and S9 had their access sites completely covered by a blanket and were not visible to the staff during their treatment. There was no documented evidence that the patients were reminded not to cover their dialysis access sites to ensure their safety during dialysis. Patient Care Tech (PCT) DD was informed of the above findings on 12/29/23 at 7:45 a.m. PCT DD uncovered the access sites. Another observation in the patient treatment area on 12/29/23 at 11:41 a.m., revealed patient who was dialyzing in S1 had access completely covered by a blanket. The Facility Administrator (FA) was notified of the above findings on 12/29/23 at 7:56 a.m. and 11:51 a.m. The FA was unable to provide documentary evidence that patients were reminded to keep their dialysis access uncovered during dialysis.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 03383 Based on a review of records and staff interview, it was determined that the interdisciplinary team (IDT) failed to adjust the patients’ plan of care for two of two sampled patients (P#2 and P#5), who did not achieve expected outcomes for blood pressure (BP) and fluid management. This deficient practice could result in adverse outcomes for P#2 and P#5. The facility census was 42. Findings were: A review of Policy titled, “Hypertension” dated 09/07/21 showed the following: Staff will recognize, report, and immediately address systolic (top number) BP greater than 180 mm/Hg and diastolic (bottom number) BP greater than 100 mm/Hg ... A review of medical records revealed the following: P#2: - P#2 was admitted on 08/30/23. Diagnosis included diabetes (metabolic disease characterized by high levels of blood sugar) and hypertension (elevated blood pressure). - A review of treatment flowsheets dated 11/13/23 through 12/18/23 showed P#2 experienced blood pressure readings that exceeded parameters of systolic BP greater than 180 mm/Hg and diastolic BP greater than 100 mm/Hg. For example: - On 11/24/23, P#2’s BP ranged between 190/96 - 216/103. PRN (as needed) Clonidine 0.1 mg was administered at 12:44 p.m. It was documented at 3:56 p.m. that BP was still elevated. - On 12/08/23, P#2’s BP ranged between 174/91 - 220/104. - P#2’s plan of care dated 09/25/23 showed the following: BP and Fluid management Goal: Achieve BP control as specified by the patient’s physician. The goal was due on 12/06/23 and open. The interventions section showed “Add, adjust, or discontinue BP medications (MD order)” in progress and “Educate patient/family/caregiver on fluid control”. There was no documented reasons why P#2 was unable to achieve BP control. There was also a lack of documented revisions made to the plan of care/ interventions to achieve BP control. P#5: - P#5 was admitted on 12/01/23. Diagnosis included diabetes and hypertension. - A review of treatment flowsheets dated 12/14/23 through 12/26/23 revealed that P#5 experienced blood pressure readings that exceeded parameters of systolic BP greater than 180 mm/Hg and diastolic BP greater than 100 mm/Hg. For example: - On 12/16/23, P#5’s BP ranged between 189/77 - 227/94. The treatment flowsheet did not show interventions to improve P#5’s BP. - Similar findings were found for BP exceeding parameters on 12/14/23, 12/21/23, and 12/23/23. A review of P#5’s plan of care dated 10/23/23 revealed the following: BP and Fluid management Goal: Achieve BP control as specified by the patient’s physician. The goal is due on 10/19/24 and open. The interventions section showed “Met goal: Continue to monitor patient” in progress and “Educate patient/family/caregiver on fluid control”. There was no documented reasons why P#5 was unable to maintain BP control. There was also a lack of documented revisions made to the plan of care/ interventions to achieve and maintain BP control. The Facility Administrator confirmed the above findings on 2/28/23 at 2:25 p.m. and did not produce updated patients’ plan of care for P#2 and P#5. A review of Policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/23 showed the following: Failure to Achieve Plan of Care Outcome: If the patient specific expected outcome as determined by the attending physician, IDT and patient for the Plan of Care is not achieved within the identified timeframe: - The IDT must adjust the patient’s Plan of Care and document changes made to the Plan of Care. - Implement the Plan of Care changes to address the identified issues ...”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 03383 Based on a review of medical records and facility policy and employee interview, it was determined that the medical director failed to ensure that staff adhered to facility policy pertaining to hypertension [elevated blood pressure (BP)] to ensure that one of two patients (P#2) sampled who experienced extremely high BP readings before, during, and after dialysis treatment, received medical care/interventions appropriate to the patient’s needs. This failure resulted in P#2’s hospitalization and could negatively affect the health and safety of the other 41 patients who were dialyzing at this facility. Findings were: A review of P#2’s dialysis treatment flowsheet dated 12/08/23 showed the following: - P#2’s estimated dry weight (EDW) was 63.5 kg (kilogram). - P#2’s pre dialysis weight was 63 kg (.5 kg under EDW). - Registered Nurse (RN) BB performed a pre-dialysis assessment at 10:46 a.m. RN BB did not document concern with patient’s extremely elevated BP of 220/104. RN BB documented “No new findings.” - P#2’s BP was 220/104 during initiation of dialysis treatment at 10:49 a.m. - PCT CC documented RN notified ... BP elevated, asymptomatic, started (dialysis treatment). - At 11:00 a.m., P#2’s BP was 213/113. - PCT CC indicated “BP elevated, patient took BP pills.” - At 11:30 a.m. (41 minutes into dialysis), P#2’s BP was 198/108. - At 12:00 p.m. (one hour and 11 minutes into dialysis), P#2’s BP was 198/108. - At 12:30 p.m. (one hour and 41 minutes into dialysis), P#2’s BP remained elevated at 196/98. - At 1:07 p.m. ( two hours and 18 minutes into dialysis), P#2’s BP was 182/98. - At 1:30 p.m. (two hours and 41 minutes into dialysis), P#2’s BP increased from 182/98 to 190/95. - At 2:07 p.m. (three hours and 18 minutes into dialysis treatment), P#2’s BP remained elevated at 187/102. - During discontinuation of dialysis treatment at 2:12 p.m., P#2’s BP was 186/99. - P#2’s post dialysis BP was 190/89 sitting and 174/91 standing. - P#2’s post dialysis weight was 62.10 kg (1.4 kg below EDW). RN BB performed a post dialysis assessment at 1:05 p.m. (one hour and seven minutes before dialysis treatment was discontinued). The question under post dialysis evaluation section of the treatment flowsheet showed “DID PRE DIALYSIS COMPLAINTS IMPROVE BY THE END OF TREATMENT: No”. There was a lack of documentation that P#2 experienced any symptoms during dialysis. RN BB’s post dialysis assessment stated the patient was alert and oriented, calm, pleasant, no complaints, had no symptoms during dialysis, had bilateral ankle and bilateral lower leg edema. A review of Policy titled, “Hypertension” dated 09/07/21 showed the following: Staff will recognize, report, and immediately address systolic (top number) BP greater than 180 mm/Hg and diastolic (bottom number) BP greater than 100 mm/Hg ... Treating Hypertension: Action Steps 1. Notify the nurse in charge if a patient has a systolic blood pressure greater than 180 mm/Hg and diastolic blood pressures greater than 100 mm/Hg. 2. The RN will assess the patient and determine if further nursing interventions are needed ... 3. If hypertension is related to hypervolemia (fluid overload), decrease EDW: Follow CMAB Fluid Management algorithm or notify physician for possible estimated dry weight adjustment outside of algorithm. 4. If hypertension is not related to hypervolemia, notify physician for additional orders/interventions. 5. Document in the patient’s treatment record. - There was a lack of documented evidence that RN BB notified the physician of P#2’s BP readings that exceeded parameters before, during, and after dialysis treatment on 12/08/23. The Facility Administrator was informed of the above findings on 12/28/23 at 1:25 p.m. and confirmed there was no interventions or follow-up documentation in progress notes for 12/08/23. A review of the Hospital Discharge Summary (HDS) dated 12/18/23 showed that P#2 was admitted to the hospital on 12/08/23 at 2:52 p.m. (dialysis treatment ended at this facility on 12/08/23 at 2:12 p.m.). The reason for hospitalization was Hypertensive urgency, ESRD. Visit diagnosis was elevated troponin, ESRD on dialysis, headache, hypertensive emergency. HDS indicated P#2 stated she took her antihypertensive medication today prior to going to dialysis. She however stated that while she was having dialysis, she looked at the monitor and noted blood pressure was markedly elevated with systolic BP greater than 200 mmHg. She further stated that after that, she started having mild diffuse headache. The headache was worse on the occipital region. The headache did not radiate to the other part of her body and did not affect her vision. The patient stated that despite completing the dialysis session, she was still having the headache and her blood pressure still remained elevated. She therefore decided to present to the emergency department for further evaluation. Pt #2 was discharged from the hospital on 12/15/23. - Despite documentation that indicated the patient was asymptomatic, the hospital record showed the patient was symptomatic during dialysis treatment.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 03383 Based on record review and patient and employee interviews, it was determined that the facility failed to implement the facility’s internal grievance process as evidenced by a lack of documented steps taken to resolve five of six documented grievances (filed on 1/16/23, 3/15/23, 5/8/23, 7/3/23, and 8/10/23) in a timely manner. This deficient practice had the potential to negatively affect the health and safety of 42 patients (P) who were under the care of this facility. Findings were: A review of the facility’s Grievance Status Report revealed the following: P#3, a patient admitted to the facility on 12/09/20 filed five grievances regarding the Home Training Nurse (HTN) on 1/16/23, 3/15/23, 5/8/23, 7/3/23, and 10/16/23. - The grievance that was filed on 1/16/23 was not resolved until 2/13/23 and was not substantiated. There was a lack of documented evidence that the nurse in charge or the Facility Administrator met with P#3 and discussed the grievance within five business days to resolve it. P#3 was offered to transfer to another clinic which was declined by the patient. - The grievance that was filed on 3/15/23 had no documented resolution. - The grievance that was filed on 7/3/23 had a resolution date of 8/1/23. However, there was a lack of documented steps taken to resolve the grievance. P#3 was given two choices: To stay at this clinic and resolve issues with HTN or to go to another clinic. P#3 stayed at this clinic due to distance from her residence. - The grievance that was filed on 10/16/23 had a resolution date of 12/01/23. There was a lack of documented evidence that the nurse in charge or the Facility Administrator met with P#3 and discussed the grievance within five business days to resolve it as quickly as possible. P#4 also phoned to complain about the HTN on 08/10/23. The documented grievance was dated 08/31/23 (21 days later). There was a lack of documented evidence that the nurse in charge or the Facility Administrator met with P#3 and discussed the grievance within five business days to resolve the grievance. A meeting was called with the nephrologist but there was no documented resolution. An interview with P#3 on 12/29/23 at 10:38 a.m. revealed that she didn’t feel like her grievances were resolved but she did not want to transfer because this clinic is close to her house. A review of Policy titled, “Patient Grievance” dated 01/02/2014 stated: All facility staff: Promptly acknowledging the patient/family members concern and reporting any patient grievances to the Nurse in Charge or Team Leader. Assisting in assessing and resolving patient grievances as appropriate. Nurse in Charge or Team Leader: Meeting with the patient/representative within 72 hours of being notified of a grievance. Assisting in assessing and resolving patient grievances as appropriate. Clinical Manager (CM): Reviewing the Patient Grievance Status Report daily. The CM reviews the Patient Grievance Status Report daily. For any new grievances, CM meets with the patient within 5 business days to discuss the grievance, resolve it as quickly as possible, and periodic updates to the patient. Documenting actions taken on the Patient Grievance Status Report and reporting this information to the Quality Assessment and Performance Improvement (QAI). The FA was notified of the above findings on 12/29/23 at approximately 11:00 a.m. and did not provide documentation to confirm that staff adhered to the facility’s grievance policy.”