Fmc - Charlotte

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to notify the physician of post-dialysis weights significantly above target weight in 1 (P-2) of 1 record reviewed with hospitalization due to fluid overload, out of a total sample of 9 records reviewed, resulting in the potential for less-than-optimal outcomes for all 55 patients currently receiving services at this facility. Findings include: Review of P-2’s medical record on 5/21/2024, revealed a 69-year-old male admitted to the in-center unit at this dialysis facility on 12/8/2022, with diagnoses which included kidney failure, acute combined systolic (congestive) and diastolic (congestive) heart failure, and fluid overload-unspecified. P-2’s dialysis schedule was every Tuesday, Thursday, and Saturday. It was noted upon record review that the patient was hospitalized 2/22/24 through 3/3/24 due to fluid overload signs and symptoms. Review of P-2’s active treatment orders (effective 4/18/24) noted the prescribed target weight (TW) was 74.3 Kg. or 164 pounds. Review of P-2’s 13 (per policy referenced below) most recent treatment sheets revealed the following: On 4/4/24; post-treatment weight of 73.8 Kg. with ordered TW of 73.0 Kg. On 4/6/24; post-treatment weight of 74.6 Kg. with ordered TW of 73.0 Kg. (1.6 Kg. over) On 4/9/24; post-treatment weight of 75.7 Kg. with ordered TW of 73.0 Kg. (2.7 Kg. over) On 4/11/24; post-treatment weight of 75.0 Kg. with ordered TW of 73.5 Kg. (1.5 Kg. over) On 4/13/24; post-treatment weight of 75.2 Kg. with ordered TW of 73.5 Kg. (1.7 Kg. over) On 4/15/24; post-treatment weight of 75.2 Kg. with ordered TW of 73.5 Kg. (1.7 Kg. over) On 4/16/24; post-treatment weight of 74.3 Kg. with ordered TW of 73.5 Kg. On 4/18/24; post-treatment weight of 75.0 Kg. with ordered TW of 73.5 Kg. (1.5 Kg. over) On 4/20/24; post-treatment weight of 75.7 Kg. with ordered TW of 74.3 Kg. (1.4 Kg. over) RN (Staff D) documented “Bilateral” ankle edema (swelling) with no measurements, no new findings, and no physician communication noted. On 4/23/24; post-treatment weight of 75.7 Kg. with ordered TW of 74.3 Kg. (1.4 Kg. over) RN (Staff E) documented no edema, no new findings, and no physician communication noted. ** Hospitalized 4/25/24 through 4/28/24 for fluid overload. On 4/30/24; post-treatment weight of 75.0 Kg. with ordered TW of 74.3 Kg. RN (Staff C) documented “Bilateral” lower leg edema with no measurements, and no new findings. On 5/2/24; post-treatment weight of 75.0 Kg. with ordered TW of 74.3 Kg. RN (Staff C) documented “Bilateral” lower leg edema with no measurements, no new findings. On 5/4/24; post-treatment weight of 75.6 Kg. with ordered TW of 74.3 Kg. (1.3 Kg. over). RN (Staff D) documented “Bilateral” ankle edema with no measurements, no new findings, and no physician communication noted. ** Hospitalized 5/9/24 through 5/17/24 for CABG (coronary artery bypass graft) and mitral valve repair. On 5/18/24; post-treatment weight of 78.7 Kg. with ordered TW of 74.3 Kg. (4.4 Kg. over). RN (Staff D) documented weight gain due to post-hospitalization. Subsequently this treatment date was not included in the 13-treatment sample size above. Review of the above findings when compared to facility policy referenced below found 9 of 13 (69%) were above the 30% threshold of 13 treatments in which the TW was exceeded by 1 Kg. or more. During an interview on 5/22/24 at 1040, the facility’s Administrator (Staff A) reviewed and acknowledged the above findings. Staff A noted that clinical staff needed to document the ankle/lower leg edema in measurable terms and communicate with the physician/nurse practitioner of P-2’s consistency in exceeding the 1 Kg. threshold of post treatment TW given P-2’s recent hospitalizations concerning fluid overload. Facility Policy: “CMAB Recommended Volume Evaluation and Management Algorithm Version 2.0 (revised 4/11/2019) stated, “If the post-treatment weight variance is greater than 1 kg. form EDW (estimated dry weight) for more than 30% of previous 13 treatments... consult physician/NP/PA for new EDW order.””

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 38304 Based on record review and interview, the Facility failed to develop a plan of care (POC) to meet the needs of the patient in 1 (P-1) of 1 record reviewed with an unstable status, from a total sample of 7 records reviewed, resulting in the potential for unmet needs and an involuntary discharge from the Facility. Findings include: P-1: This 56 year-old patient was admitted to the Facility on 7/7/2021 for diagnoses which included kidney failure, anemia, and hypertension. P-1 received dialysis treatments three times weekly (Mon-Wed-Fri). On 5/22/24, record review of the POC concerning P-1 (dated 9/13/2023) revealed the patient was made unstable due to chronic missed treatments. The 9/13/23 POC documented the following: “Pt (patient) misses multiple treatments due to living 30+ miles from the clinic and struggling with paying for gas. Does not want to switch MD’s. SW (Social Worker) applied pt for NFK Emergency Fund last month. Pt. educated on missed and shortened treatments. The POC was signed off on 9/13/23 by all members of the IDT (Inter-disciplinary Team). The following month on 10/4/23, the POC status for P-1 was updated back to “Stable” status. Further review found no evidence in the POC indicating increased compliance by P-1. In addition, the lone section in the POC which addressed the patient’s missed treatments documented the following by the SW: “Pt. reports struggling with getting to tx (treatment) due to gas money and living 30 miles from the clinic. SW applied pt. for Bob Meyer Patient Emergency Fund through NFK in August but pt. was denied due to not meeting criteria. Pt. does not want to move clinics and he does not want to switch to another MD. SW to continue to educate/assist pt.” The POC was signed off on 9/13/23 by all members of the IDT (Inter-disciplinary Team). In addition, review of the clinical notes by Skilled Nursing (Staff B) documented on 10/13/23 that “Patient continues to have poor clearance with dialysis treatments, appears to be recirculating... Explained the urgency to (wife) that patient should be seen as dialysis access left upper arm is not functioning well at this time.” On 5/22/24, review of P-1’s treatment logs which detailed the times the patient was compliant or non-compliant with scheduled treatments noted the following: August 2023 had a total ordered treatment time of 51 hours. P-1 attended 18 hours and 44 minutes, with an “Incomplete Time” of 32 hours and 16 minutes. This amount was deemed sufficient to re-classify the patient to an “Unstable” status. September 2023 had a total treatment time of 55 hours and 15 minutes. P-1 attended 24 hours and 53 minutes, with an “Incomplete Time” of 30 hours and 22 minutes. October 2023 had a total treatment time of 55 hours and 15 minutes. P-1 attended 23 hours and 14 minutes, with an “Incomplete Time” of 32 hours and 01 minutes. November 2023 had a total treatment time of 55 hours and 15 minutes. P-1 attended 23 hours and 25 minutes, with an “Incomplete Time” of 31 hours and 50 minutes. January 2024 had a total treatment time of 55 hours and 15 minutes. P-1 attended 15 hours and 57 minutes, with an “Incomplete Time” of 39 hours and 18 minutes. February 2024 had a total treatment time of 46 hours and 45 minutes. P-1 attended 15 hours and 17 minutes, with an “Incomplete Time” of 31 hours and 28 minutes. Review of a clinical note by the Facility clinic manager (Staff A) dated 1/31/24 documented “(Physician) advised that she will be D/C (discharging) patient from her care due to severe non-compliance. I spoke to the patient and he confirmed this and asked that I contact (Medical Director/Staff B) to see if he would accept him as a patient.” Staff A then documented on 2/9/24 the following: “After review (Staff B) stated he will not be accepting patient to his care.” Additional review of the medical record revealed Staff A proceeded with appropriate measures to find placement among other dialysis facilities which was successful. P-1 had his last treatment at the Facility on Friday 3/1/24, and was transferred to another facility later that day. P-1 received his first dialysis treatment at the new facility on Monday 3/4/24 with no treatments missed during the transfer. On 5/22/24, interviews concerning the above findings were reviewed and acknowledged by Staff A (at 0940) and Staff B (at 1015). Both were noted that the IDT should have kept P-1’s status as “Unstable” to better address the patient’s needs and failed to adhere to its policy referenced below. Facility Policy: “Comprehensive Interdisciplinary Assessment and Plan of Care” (dated 7/3/2023) Version 6 stated, “Patient stability must be reviewed monthly. The interdisciplinary team will offer input to the attending physician who will determine whether the patient is stable or unstable on the criteria included in this policy... Monthly re-assessment and any POC updates related to the reason the patient is considered “unstable” must be documented until the issues have been resolved ...””

“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: 46476 Based on record review and interview, the facility failed to ensure staff monitored and reported elevated blood pressure (BP) readings which were above parameters specified per facility policy in 1 (P-5) of 7 sample records reviewed resulting in unmanaged fluid volume status for that patient and the potential for a poor patient outcome. Findings include: Facility policy titled “Patient Assessment and Monitoring”, Reference Number: 45284, was reviewed on 5/22/24. On page 4., it stated “During Treatment- Follow the steps below for monitoring patient ... Step 1 Blood Pressure ... Report to the nurse: Systolic blood pressures greater than 180 mm/Hg Diastolic blood pressure greater than 100 mm/Hg ...” P-5: This 60-year-old was admitted to the facility on 4/25/23 with diagnoses which included end stage kidney disease, type 2 Diabetes, and high blood pressure. The medical record was reviewed on 5/22/24 and included 6 hemodialysis treatment sheets between the dates of 4/13/24 and 5/7/24. During review of the hemodialysis treatment sheets, the following were noted: On the hemodialysis treatment sheet dated 4/20/24, the following BP’s were recorded by a patient care technician (PCT): At 1224 the BP was recorded as 183/104 millimeters of mercury (mm/Hg). At 1304 the BP was recorded as 196/98 mm/Hg At 1333 the BP was recorded as 210/112 mm/Hg At 1406 the BP was recorded as 210/112 mm/Hg At 1433 the BP was recorded as 200/95 mm/Hg At 1532 the BP was recorded as 197/104 mm/Hg On the hemodialysis treatment sheet dated 4/30/24, the following BP’s were recorded by a PCT: At 1237 the BP was recorded as 189/104 mm/Hg At 1338 the BP was recorded as 190/112 mm/Hg At 1402 the BP was recorded as 196/118 mm/Hg At 1505 the BP was recorded as 207/115 mm/Hg On the hemodialysis treatment sheet dated 5/4/24, the following BP’s were recorded by a PCT: At 1236 the BP was recorded as 190/115 mm/Hg At 1309 the BP was recorded as 179/134 mm/Hg At 1432 the BP was recorded as 229/89 mm/Hg Following the above BP recordings on each treatment sheet listed above, the PCT who recorded the elevated BP finding failed to notify the registered nurse (RN) at the time of the finding. There were no additional notes documented by the RN on any of the treatment sheets above indicating awareness of the elevated BP recordings at the times indicated. This finding was reviewed and acknowledged on 5/22/24 during interview at 1300 with the Facility Administrator (Staff A). Staff A stated that PCT’s should be notifying the RN of elevated BP findings, and RN’s should be assessing the patients for symptoms or interventions needed.”

“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: 46476 Based on record review and interview, the facility failed to ensure patient treatments were delivered as prescribed in 1 (P-5) of 7 sample records reviewed potentially resulting in difficulty achieving and sustaining the prescribed dose of dialysis to meet the hemodialysis needs of this patient. Findings include: P-5: This 60-year-old was admitted to the facility on 4/25/23 with diagnoses which included end stage kidney disease, type 2 Diabetes, and high blood pressure. The medical record was reviewed on 5/22/24 and included 6 hemodialysis treatment sheets between the dates of 4/13/24 and 5/7/24. The active dialysis prescription for the period of hemodialysis treatments reviewed included a Blood Flow Rate (BFR) of 400 milliliters per minute (mL/min), and a Dialysate Flow Rate (DFR) of 800 mL/min for a duration of 3 hours and 45 minutes each treatment. During review of the hemodialysis treatment sheets, the following were noted: On the treatment sheet dated 4/13/24, the total treatment time was 3 hours and 48 minutes. The DFR was recorded at 1305 running at a rate of 500 mL/min (300 mL/min less than prescribed) and continued at that rate until it was changed to 800 mL/min at 1435. There was no documentation indicating why the DFR was not running as prescribed for 1 hour and 30 minutes of this treatment. On the treatment sheet dated 5/7/24, the total duration of the treatment was 1 hour and 58 minutes. The BFR was recorded at 1231 (beginning of treatment) to be running at 150 mL/min (250 mL/min less than prescribed) and the DFR was recorded at the same time to be running at 500 mL/min (300 mL/min less than prescribed). The BFR was again recorded at 1303 to be running at 200 mL/min (still 200 mL/min less than prescribed) and the DFR remained at 500 mL/min. The BFR and DFR remained at that rate until treatment was discontinued per patient request at 1427. There was no documentation indicating why the BFR and DFR both were running at lower rates than prescribed for the duration of this treatment. This finding was reviewed and acknowledged on 5/22/24 during interview at 1300 with the Facility Administrator (Staff A). Staff A stated that if the prescription needed to be altered for the treatment, an order should have been obtained for the change and then documentation should have been included on the treatment sheet with the reason of the dialysis prescription change.”

“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: 46476 Based on observation, interview, and record review, the Medical Director failed to ensure policy relative to pre-drawn medication labeling was adhered to by all staff resulting in unsafe medication administration practices and potentially resulting in poor patient outcomes for all 55 incenter hemodialysis patients currently under the care of the facility. Findings include: Facility policy titled “Medication Preparation and Administration”, Reference Number: 47488, was reviewed on 5/22/24. On page 2., it stated “All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication. If more than one syringe of the same medication is needed for a single patient, mark the label as “1 of 2, 2 of 2” ... Oral medications not being administered immediately must also be labeled as indicated above.” On page 3. It stated “Medications may be pre-drawn up to 4 hours prior to administration ...” On 5/21/24 at 1145, flash tour of the hemodialysis treatment floor was performed. During initial observations, the medication drawer in the centralized medication preparation area was viewed. It was observed that 5 medication cups, each containing oral medications, were found in the top drawer with a patient information label sitting under each of the medication cups (not attached to the cup). There were no dates, times, or staff initials noted on any of the medication cups containing the pre-drawn medications. It was also noted that 14 pre-drawn IV medications were found in the second drawer of the nurses medication preparation area. The syringes were stuck together in pairs (2 syringes each) by a patient information label. The syringes were not labeled independently with any patient information, and no date, time or staff initials were found on the patient label or the syringes. It was unclear how long the pre-drawn medications had been sitting in the drawers or which staff member had pre-drawn them (both oral and IV). The Facility Administrator (Staff A) was queried at the time of the finding of whether the medications were pre-drawn according to facility policy. Staff A observed the pre-drawn medications (oral and IV) in the drawers and stated that the medications should have been labeled properly with the patient information and include the time, date, and initials of the staff member who prepared them. On 5/21/24 during interview at 1600 with the Medical Director (Staff B), Staff B was notified of the above finding and stated that it is expected that all staff follow policies and procedures of the facility.”