Fmc - Manistee

“Methods for Sharing Information CFR(s): §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to ensure their method of sharing patient information in the event of an actual emergency was accurate and updated, resulting in the potential for unaccounted patient(s) and an impaired emergency response for all 28 patients currently serviced by the facility. Findings include: On 11/18/24 at 0924, an inspection of the facility’s emergency evacuation “To Go” box was performed. The patient list located in the “To Go” box was reviewed and found to be significantly outdated. The list documented it was “Last Updated” on 02/27/24. When this list was compared to the current patient roster, a total of 15 patient names were found in error; 5 names that have been discharged and 10 current patients not found on the 2/27/24 list. This finding was reviewed and acknowledged by the Administrator (ADM-1) and the Clinical Manager during interview on 11/18/24 at 1045. ADM-1 further acknowledged this did not meet facility expectations or its policy referenced below. Facility Policy: “Medical Record Guidelines” Version 5 (Pub. 11/4/2024) stated “The dialysis facility must maintain complete, accurate, and accessible records on all patients.””

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 46476 Based on observation, record review, and interview, the facility failed to maintain a sanitary environment within the dialysis unit resulting in the potential for cross contamination and spread of infectious agents to the 11 patients receiving dialysis at the time of the observations. Findings include: Facility policy titled “Personal Protective Equipment”, Reference Number: 477663, was reviewed on 11/20/24. On pages 1-2, it stated “Policy ... All personal protective equipment shall be removed prior to leaving the treatment area.” On 11/18/24 during hemodialysis treatment floor observation between 1130 and 1200, PCT-1, a patient care technician (PCT), was observed in the patient treatment area and moving about the treatment stations while wearing a gown and face shield (personal protective equipment- PPE). PCT-1 was observed leaving the treatment area and entering the water room outside of the treatment area without first removing the potentially contaminated PPE. On 11/19/24 during hemodialysis treatment floor observation between 1115 and 1200, PCT-2, a PCT, was observed in the patient treatment area and moving about the treatment stations while wearing a gown and face shield. PCT-2 was observed leaving the patient treatment area and entering the water room outside of the treatment area without first removing the potentially contaminated PPE. On 11/20/24 at 1130, the Clinical Manager (CM) was observed hanging signage on the door to the water room which stated, “No PPE Beyond This Point”. At 11:40, CM was queried to why the sign was placed. CM stated that she saw PCT-1 entering the water room with PPE which had been worn from the treatment floor. CM stated that she immediately educated PCT-1 at the time of the finding. On 11/20/24 at 1145, interview was conducted with the Director of Operations (DO) and query was made regarding whether staff should be entering the water room with potentially contaminated PPE. DO stated that staff should be removing PPE before leaving the treatment area and acknowledged that the observation was not the expected practice according to facility policy.”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 47976 Based on observation, interview, and record review, the facility failed to ensure confidentiality of protected medical information, resulting in the potential unauthorized access to medical information of the 23 patients currently receiving dialysis at this facility. Findings include: **Policy titled “Medical Record Guidelines” (dated 11/4/24) stated, “Each facility must safeguard patient medical records against loss, destruction or unauthorized use.” During dialysis floor observation on 11/18/24 from 1100 to 1400, it was noted the binder containing a log to record patient weights was left open and unattended on the counter next to the scale. The log contained patient last names and weights that could be visible to any patient using the scale. Findings were reviewed with and acknowledged by the Director of Operations (DO) and Clinical Manager (CM) during an interview on 11/20/24 at 1130.”

“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: 47976 Based on record review and interview, the facility failed to ensure the blood flow rate (BFR) was delivered at the prescribed rate in 2 (P-1, P-5) of 5 total records reviewed, resulting in the potential to impact the adequacy for all 23 patients served by this facility. Findings include: P-1: This 53-year-old patient was admitted to this dialysis facility on 9/3/24 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 11/19/24, it was determined the BFR was ordered at 400 milliliters per minute (mL/min). Upon review of the last 6 treatment sheets, it was noted the BFR was run incorrectly as follows: On 11/2/24, the BFR was recorded as 300 mL/min by the patient care technician (PCT) upon initiation of treatment at 0805. Throughout the treatment time, 5 additional checks were done by a PCT or registered nurse (RN). Each interdialytic check indicated the BFR was run between 250 mL/min and 300 mL/min, with an average of 270 mL/min noted at the end of treatment under the “Post-Dialysis Vitals and Evaluation”. The interdialytic checks did not indicate a reason for the BFR being run below the prescribed treatment rate. Under “Events & Interventions” on the daily treatment sheet, it was noted the patient was unable to maintain an arterial pressure of less than -250 mm Hg during treatment. This is often a reason for the BFR being lowered, however, there is no documentation of this being the reason during this treatment session. Additionally, the arterial pressure values during this treatment were reviewed. According to the interdialytic checks, the patient’s arterial pressure was recorded between -125 mm Hg and -194 mm Hg throughout the treatment. There was no evidence of the patient’s arterial pressure being recorded greater than the facility policy of -250 mm Hg. On 11/5/24, the BFR was recorded at 250 mL/min by the RN upon initiation of treatment at 0758. The arterial pressure was recorded at -100 mm Hg at this time. The registered nurse indicated the BFR was lowered to 250 mm Hg due an elevated arterial pressure. Throughout the treatment session, 7 additional checks were done by a PCT or RN. The next interdialytic check at 0836 indicated the BFR was run at 250 mm Hg and then increased to 300 mm Hg for the remainder of the treatment. There was no documentation regarding the reason for continuing the BFR at a rate below the prescribed rate. There were no additional notes regarding the arterial pressure being too high. Arterial pressures were recorded between -98 and -194 mm Hg throughout treatment. There was no evidence of the patient’s arterial pressure being recorded greater than the facility policy of -250 mm Hg. During an interview with the Clinical Manager (CM) on 11/20/24 at 1122, CM stated the patient was having issues with his arterial pressure levels due to a malfunctioning catheter. CM stated staff attempted to increase the BFR during the treatments above, however, it had to be decreased before the next recorded check due to increased arterial pressures. CM agreed the documentation does not show evidence of this. The Director of Operations (DO) was present during the interview and acknowledged the findings. 38304 P-5: This 89-year-old patient started dialysis at this facility on 6/20/2024, with diagnoses which included renal failure, hypertension, and anemia. The patient received dialysis treatments three times per week (Mon-Wed-Fri). During record review on 11/19/24, the six most recent treatment sheets were evaluated, all were ordered with a BFR (blood flow rate) of 400 milliliters per minute (mL/min). However, the most recent treatment sheet on 11/18/24, failed to follow the ordered BFR prescription rate despite having 7 of 7 documented arterial pressures below negative 250 mmHg per facility policy. Facility Policy: “Patient Assessment and Monitoring” Version 4 (Pub. 5/1/2023) stated, “Check machine settings and measurements: Check arterial pressure is less than negative 250 mmHg.” In addition, the Medical Director (MD-1) was queried during an interview on 11/20/24 at 0935 about the upper limit for arterial pressures that would warrant lowering the ordered BFR rate. MD-1 replied, “At least 250 (negative mmHg.)” MD-1 further noted that keeping the prescribed BFR would help ensure optimal adequacy or effectiveness of the dialysis treatment. The documented BFR values and accompanying arterial pressures from the 11/18/24 dialysis treatment are as follows: Time: BFR Arterial Pressure 12:33 350 -170 13:04 275 -236 13:34 200 -212 14:01 150 -3 14:33 150 -187 15:02 150 -162 15:34 200 -219 Under “Post-Dialysis Vitals and Evaluation”, the average BFR for the dialysis treatment was only 190 mL/min. versus the ordered rate of 400 mL/min. Further, Staff RN-1 documented “No new findings” under “New complaint or observations which developed during dialysis.” Additional review of the 11/18/24 treatment sheet noted RN-1 was aware and documented concerns of elevated arterial pressures from 12:33 to 13:34. However, no evidence was found in the medical record which indicated P-5’s arterial pressure had ever exceeded the facility’s policy of -250 mmHg. Subsequently, evidence which warranted changing the BFR prescription was not found, resulting in P-5 not receiving the appropriate dialysis prescription. The above findings were reviewed and acknowledged by the Administrator during an interview on 11/20/24 at 0935.”

“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: 47976 Based on observation, record review, and interview the medical director failed to ensure medications were disposed of by their expiration date per policy, and failed to ensure the Initial Nursing Assessment was completed prior to the start of the first dialysis treatment in 1 (P-5) of 5 total records reviewed, resulting in the potential to affect the safety of all 23 patients currently served by this agency. Findings include: *Policy titled “Medication Preparation and Administration” (dated 2/5/23) stated, “Expiration dates for all stored medications are to be monitored on a monthly basis ....Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law ....CDC immunization program states vaccine are to be discarded per manufacturer’s expiration date.” During dialysis floor observation on 11/18/24 at 1140, it was noted the medication refrigerator contained 4 boxes of vaccines labeled “Pneumococcal 13-valent Conjugate” with the expiration date of 9/2024. The Clinical Manager (CM) was made aware of the findings at the time of discovery. During an interview with the Medical Director (MD-1) on 11/20/24 at 0945, MD-1 was asked if he expects staff to following agency policy. MD-1 stated, “Of course, I expect all staff to follow policy.” Findings were again reviewed with and acknowledged by the Director of Operations (DO) during an interview on 11/20/24 at 1120. 38304 P-5: This 89-year-old patient started dialysis at this facility on 6/20/2024, with diagnoses which included renal failure, hypertension, and anemia. During record review on 11/19/24, it was noted the Initial Nursing Assessment (INA) was performed on 6/20/2024, with a documented time of 1044. However, review of P-5’s first dialysis treatment (6/20/2024) had a documented start time of 1037, prior to the INA. This finding was reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 11/20/24 at 0932. Staff A acknowledged this did not meet facility expectations or its policy referenced below. Facility Policy: “Comprehensive Interdisciplinary Assessment and Plan of Care” Version 6 (Pub. 7/3/2023) stated, “A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs.””