Fmc - Escanaba

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 36887 Based on interview and record review, the facility failed to 1) provide dialysis as prescribed for 1 (P-4) of 6 patients reviewed, and 2) failed to ensure the plan of care was signed and/or dated in a timely manner by all members of the interdisciplinary team for 3 (P-2, P-5, P-6) of 6 patients whose plans of care were reviewed resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes. Findings include: See Specific Tags: V-543 Failure to provide dialysis as prescribed V-556 Failure to sign and/or date the plan of care”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 29955 Based on observation, interview, and record review, the facility failed to maintain clean areas separated from dirty items resulting in the potential for the spread of infectious disease to 8 of 8 patients receiving dialysis treatment at the time of observation. Findings include: On 6/24/2025 at 0853 during observation while in the treatment area a stethoscope was observed hanging from a wire device on the wall touching the dirty lab area at station #16. On 6/24/2025 at 0901 during observation while in the treatment area a biohazard bin was observed to be within 6 inches of a clean supply storage shelving unit. On 6/24/2025 at 0920 during initial tour of the treatment area a wheelchair was observed parked against a large trash can across from station #8. 36887 On 6/24/2025 at 0943, the lab was entered. A large cardboard box was present on the counter next to the handwashing sink which had a large plastic bag with the opening of the bag draped down each side of the box. The box was filled to the top with clean vacutainers (for drawing blood) and there was no covering present. On 6/26/2025 at 0950, while making observations on the treatment floor, a face shield was observed hanging on the corner of the glass by the hand washing sink across from Station #5. Staff A’s first name was written across the bill of the shield and dried opaque droplets and streaks were visualized on the shield. On 6/24/2025 at 0952, goggles were observed hanging by one arm over the glass by the bleach solution used for cleaning. Smudges were clearly seen on the lenses of the goggles. On 6/24/2025 at 0953, goggles were observed sitting on the nurse’s station desk near the radio. Smudges were clearly seen on the lenses. On 6/24/2025 at 0955, goggles were observed sitting on the nurse’s station counter across from Station #3 and behind the timer used for water room checks. Dried opaque droplets and smudges could be seen on the lenses. On 6/24/2025 at 0956, two pairs of goggles were visualized across from Station #12, one pair sitting on the nurse’s station counter, and the other sitting on the desk. Both pairs of goggles had dried opaque droplets and smudges present on the lenses. On 6/24/2025 at 0958, a shield was observed hanging on a hook between the dirty and clean counters across from Station #11. Staff G’s name was writting across the inside of the bill of the shield. Facility policy titled “Dialysis Precautions” published 1/4/2012 states, “Clean area: An area designated for clean and unused equipment, supplies and medications. Dirty area: An area where this is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas wehre used supplies, equipment or blood samples are handled or stored.””

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 38905 Based on observation and interview, the facility failed to ensure proper maintenance and monitoring of the water treatment system. This deficient practice has the potential to affect all 28 incenter patients by exposing them to inadequately treated dialysis water. Findings Include: During a tour of the Water Room, on 6/24/25 at 12:18, observation of the brine tank for the water softener found that it was half full of water while the salt level was roughly 5 inches below the water line. When asked if this was the normal level for the salt, Bio-med “J” stated that its “normally higher” and above the water. When asked how often the tank is checked, Bio-med “J” stated it should be daily.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 36887 Based on observation, interview, and record review, the facility failed to maintain a safe and functional environment resulting in the potential for transmission of infectious agents for 8 of 8 patients who were currently dialyzing on the treatment floor. Findings include: On 6/24/2025 at 0923, upon entering the short hallway to the treatment floor, the soiled utility room door was observed to be propped open. On 6/24/2025 at 0955, Staff A was queried as to why the soiled utility room door was propped open to which she replied it was open for staff convenience. On 6/24/2025 at 0940, the clean supply room was entered and two cardboard boxes were found to be sitting on the floor under the shelves. Additionally, there were 20 collapsed, unused boxes sitting on the floor and leaning against one of the other boxes sitting on the floor. These observations were confirmed by Staff C at the time of discovery. On 6/24/2025 at 0943, the lab was entered and 7 new, collapsed boxes were leaning against the wall behind the trash can, 4 new, collapsed boxes were sitting on the counter next to the dirty sink, and 11 new, collapsed boxes were sitting next to the handwashing sink and actually hanging partially over the sink area. These findings were confirmed by Staff C at the time of discovery. 29955 On 6/24/2025 at 0825 during observation in the dialysis treatment area it was revealed two cardboard boxes located in the treatment area - one at the emergency crash cart and one at the nurse’s station. On 6/24/2025 at 0908 during observation in the dialysis treatment area it was revealed the window sill behind station #14 had an accumulation of dust. On 6/24/2025 at 1020 during observation in the dialysis treatment area it was revealed an accumulation of dust on the chaise behind station #4. On 6/24/2025 at 1500 a tour of the dialysis treatment area was conducted with staff A, Facility Administrator. Staff A was queried if the cleaning service was dusting various areas including window sills in the facility. Staff A stated that the cleaning company was supposed to dust but was unsure if dusting occurred on a regular basis. On 6/24/2025 at 1535 during a tour with staff A, Facility Administrator, and staff I, Director of Operations, it was revealed a large amount of dust located in the common corridor prior to the water room on top of the staff lockers. Staff A and staff D verified the finding. On 6/24/2025 at 1550 during a tour of the home dialysis training rooms an accumulation of cardboard boxes were observed in the patient care area. On 6/24/2025 at 1555 an interview occurred with staff K, home dialysis nurse/tech. Staff K was queried about the cardboard boxes. Staff K stated the facility was limited on storage space and had no other place to store the items. According to the policy titled, “General Cleanliness and Infection Control Guidelines,” dated 5/05/2025, policy #46785, it revealed the following, “ All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices and restrooms.....””

“PR-INFORMED OF INTERNAL GRIEVANCE PROCESS CFR(s): 494.70(a)(14) The patient has the right to- (14) Be informed of the facility’s internal grievance process; This Standard is not met as evidenced by: 29955 Based on interview and record review, the facility failed to provide current contact information for the facility and corporate contacts denying all 34 patients the right to file a grievance with internal agencies. Findings include: On 6/24/2025 at 0825 during tour of the dialysis waiting room area, a document review occurred of the information sheet titled, “What to do if you have a concern...” dated 1/2/2014, version 1, explaining how to file an internal complaint/grievance. Further review of the document on 6/24/2025 at 1345 it was revealed that the listed Social Worker was no longer employed at the facility, the Area Manager or Director of Operations was blank, and the Regional Vice President was also no longer employed at the facility. The phone number for placing an internal complaint with corporate was also incorrect. On 6/24/2025 at 1530, during an interview with staff I, the Director of Operations, it was asked if the contact information for filing an internal grievance was correct. Staff I responded, “No””

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 29955 Based on interview and record review, the facility failed to provide current contact information for the State Agency and End Stage Renal Disease (ESRD) Network resulting in denying all 34 patients the right to file a grievance with external agencies. Findings include: On 6/24/2025 at 0825 during tour of the dialysis waiting room area, a document review occurred of the information sheet titled, “What to do if you have a concern...” dated 1/2/2014, version 1, explaining how to file a complaint/grievance with outside agencies. It was noted that the department and address to file an external grievance with the state agency was incorrect. The information sheet stated, “The State Agency...MI Dept of Community Health, PO Box 20664, Lansing, MI 48909, 800-882-6066.” Further review of the information sheet revealed the name and address stated for the End Stage Renal Disease Network was also incorrect. The information sheet stated, “Network 11, 970 Raymond Ave Suite 205, St. Paul, MN 55114, 800-973-3773.” On 6/24/2025 at 1530, during an interview with staff I, the Director of Operations, it was asked if they knew the contact information for the State Agency and ESRD Network was incorrect. Staff I stated, “No, I did not know it was incorrect.””

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 36887 Based on interview and record review, the facility failed to identify 1 (P-2) of 2 unstable patients resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes. Findings include: On 6/24/2025 at 1025, review of the hospitalization log revealed P-2 had been hospitalized 10/17/2024-10/23/2024 (6 days), and 10/25/2024-11/5/2024 (11 days). Review of P-2’s medical record revealed the last plan of care was done on 10/15/2024 in which the patient was deemed stable; no plan of care was present for November 2024. This was confirmed by Staff I on 6/25/2025 at 1415 who agreed P-2 should have been made unstable in November 2024 due to his being hospitalized for 17 days within 1 month. It was noted P-2 did not sign the 10/15/2024 plan of care until 11/6/2024. Additionally, P-2 returned to the hospital 12/6/2024, and while there, expired 12/12/2024. Facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care” published 7/3/2023 states, “The patient’s Plan of Care will be guided and developed based on the findings identified in the Comprehensive Interdisciplinary Assessment. Patient stability must be reviewed monthly. The interdisciplinary team (IDT) will offer input to the attending physician who will determine whether the patient is stable or unstable on the criteria included in this policy...Unstable patients must be reassessed by the IDT monthly...The following are unstable criteria: Extended or Frequent hospitalizations: a. Hospitalization of more than 15 days with discharge occurring within the last 30 days or b. More than 3 admissions in the last 30 days...””

“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: 45246 Based on interview and record review, the facility failed to report, assess, and address high blood pressure for one patient (P-4) of 6 patients reviewed for blood pressures during treatment resulting in the potential for unrecognized fluid status changes and poor patient outcomes. Findings include: On 6/26/25 at approximately 0930 during medical record review for P-4 dialysis treatment sheets on 6/20/25 revealed that patient had elevated blood pressure of 188/100 at 1122 and 182/98 at 1334 during her treatment. At 1418 P-4 blood pressure was documented as 199/102. Treatment was discontinued at 1443 and P-3 was sent home with blood pressure 190/99. No documentation was evident in patient record regarding nurse or physician notification and treatment of the elevated blood pressure. Further record review revealed there was a provider’s order for Clonidine HCl 0.2 mg PO (oral) as needed for systolic BP (blood pressure) higher than 190. During the interview with facility patient care technician, Staff D, on 6/25/25 at 1115, she stated that if patient’s treatment parameters (like blood flow or dialysate rates) or the vital signs are outside of the indicated range she would notify the nurse and document in the patient’s record. On 6/26/25 at approximately 1005 the Director of operations, Staff I, was interviewed. She stated that staff nurses need to notify physician of any abnormal assessments or findings during the dialysis treatments. This will include elevated blood pressure. Facility policy “Patient Assessment and Monitoring”, published 5/01/23, #45284, was reviewed and revealed: “Data collection. Direct patient care staff may collect data such as weight, BP (blood pressure), pulse, respirations, temperature, general observations, access, and complaints reported by the patient. If the PCT/LPN note any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, 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 the clinical judgment for additional instructions. During treatment. Obtain blood pressure and pulse rate every 30 minutes or more is needed but not to exceed 45 minutes or per state regulations. Report to the nurse: Systolic blood pressures greater than 180 mm/Hg”.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 36887 Based on interview and record review, the facility failed to ensure patients signed and/or timely dated the plan of care for 3 (P-2, P-5, P-6) of 6 patients reviewed for plans of care resulting in the potential of patients being uninformed about their care and loss of patient rights to participate in their care. Findings include: Review of the medical record for P-2 revealed an invitation to the plan of care meeting for 10/15/2024 in which case the patient eleceted to have the nurse review the care plan with him after the interdisciplinary team (IDT) met. On 10/15/2024, the IDT met and discussed the plan of care. It was noted P-2 did not dialyze that day. The patient signature was obtained 11/6/2024. A note was present stating P-2 had been hospitalized. On 6/24/2025 at 1025, review of the hospitalization log from the past 12 months revealed P-2 was hospitalized on 10/17/2024-10/23/2024, and 10/25/2024-11/5/2024. On 6/25/2025 at 1330, review of the Missed or Shortened Treatment Report from 10/1/2024-10/31/2024 revealed P-2 had been in the clinic on 10/15/2024; however, dialysis had not been started and he was sent to the Emergency Department (ED) for a medical emergency. Additionally, P-2 was in the clinic on 10/24/2024 and ran dialysis for 1 hour and 37 minutes prior to being sent out again for a medical emergency. On 6/25/2025 at 1015, Staff A was queried as to why the IDT met regarding P-2 when he had been taken to the hospital, and why a signature had not been obtained when he was in the clinic on 10/24/2024. Staff A stated the IDT met anyway as the patient had indicated he did not want to be present for the meeting and wished to review it with the nurse later. She was not sure why it had not been reviewed with him the next time he was in the clinic as they try to get a patient signature within 7 days of the plan of care meeting. 29955 On 6/25/2025 at 1420 during record review of P-6’s plan of care (POC) meeting signature page dated 3/26/2024, it was revealed all members of the IDT (Interdisciplinary Team) had signed the POC with the exception of P-6. On 6/25/2025 at 1430 during record review of P-6’s POC meeting signature page dated 3/14/2025, it was revealed all members of the IDT had signed the POC with the exception of P-6. On 6/25/2025 at 1500 during record review of P-5’s POC meeting signature page dated 9/25/2024, it was revealed all members of the IDT had signed the POC with the exception of P-5. On 6/25/2025 at 1510 an interview occurred with staff L, the Home Dialysis program nurse. Staff L confirmed the findings. Staff L was queried why P-5 had not signed the POC. Staff L was unable to provide an answer why P-5 would not have signed. Staff L was queried why P-6 had not signed his POC’s. Staff L stated she was unaware of P-6’s POCs not being signed, but explained that P-6’s POC from 3/14/2025 was not signed because he had gone into the hospital. Staff L was then asked if P-6 was in the hospital on 3/14/2025. Staff L stated that P-6 was not in the hospital at that time and had attended clinic on that day, but signatures from all patients were not obtained until all staff had signed the POC which would be obtained in 30 days from the day of the POC meeting. On 6/25/2025 at 1600 a record review occurred of the policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/3/2023, version 6, Reference #45283. According to the policy under the subtitle “Comprehensive Assessment Participation and Plan of Care Review” it revealed, “ ...If the patient chooses to not sign their plan of care, the reason for refusal must be documented in the patient’s medical record.””

“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: 36887 Based on observation, interview, and record review, the medical director failed to ensure staff adhered to facility policy and procedure regarding 1) blood flow rates and dialysate flow rates running as prescribed by the physician for 3 (P-1, P-3, P-4) of 6 patients reviewed, 2) blood pressure monitoring during treatment for 1 (P-1) of 6 patients reviewed, and 3) initial nursing assessments being completed prior to the start of treatment for 2 (P-1, P-2) of 2 patients reviewed resulting in the potential for ineffective treatments and poor patient outcomes. Findings include: 1) Review of the medical record for P-1 revealed physician orders for a blood flow rate (BFR) to be run at 450 milliliters/minute (ml/min) and a dialysate flow rate (DFR) to be run at 800 ml/min. Treatment was to last for 255 minutes (4 hours, 15 minutes). Review of the treatment sheet dated 6/11/2025 revealed P-1 was started with a DFR of 800 ml/min and continued at that rate until 1405 when the DFR was changed to 500 ml/min for 13 minutes and then was changed back to the prescribed 800 ml/min. There was no documentation present indicating why the DFR had been changed. Review of the treatment sheet dated 6/13/2025 revealed P-1 was started on treatment at 1002 with a BFR of 200 ml/min until 1121 when it was changed to 450 ml/min. She continued at 450 ml/min until 1228 when the BFR was changed to 285 ml/min. P-1 ran with a BFR of 285 ml/min until treatment was terminated at 1418. No documentation was present as to why the changes had been made. On 6/25/2025 at 1015, Staff A stated if changes are made to the BFR or DFR, there should be documentation present as to why they were changed. 2) During review of P-1’s medical record, review of treatment sheets dated 6/11/2025-6/23/2025 revealed the patient dialyzed for 255 minutes (4 hours, 15 minutes) and the patient’s vital signs were not monitored nor documented every 30-45 minutes on the following dates and times: On 6/11/2025 from 1307-1405 (58 minutes) On 6/13/2025 from 1014-1105 (51 minutes) On 6/25/2025 at 1015, Staff A was queried as to her expectation for monitoring a patient during treatment to which she stated the patient should be checked “every half hour.” Facility policy #56284 titled “Patient Assessment and Monitoring” published 5/1/2023 states, “During Treatment Obtain blood pressure and pulse rate every 30 minutes or more often as needed but not to exceed 45 minutes...” 3) Review of the medical record for P-1 revealed she started treatments on 1/24/2025. Review of the initial nursing assessment/cascade revealed the assessment was completed 1/24/2025 at 1054. The initial treatment was started 1/24/2025 at 1040. Review of the medical record for P-2 revealed he started treatments on 6/27/2024. Review of the initial nursing assessment/cascade revealed the assessment was completed on 6/24/2024 at 1224. The initial treatment was started 6/24/2024 at 1200. On 6/25/2025 at 1015, Staff A was shown the above findings. Staff A stated she did not understand how that could have happened as “the computer won’t allow it.” Facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care” published 7/3/2023 states, “A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs.” 45246 1) On 6/25/25 at approximately 1300 review of P-3 treatment sheets revealed the following documentation. The treatment flowsheet dated 6/17/25 had dialysis treatment documented as started at 0623 and completed at 0953. P-3’s treatment orders indicated: BFR (blood flow rate)- 450, DFR (dialysate flow rate)- 800. At 0930 BFR was recorded 450 (as ordered) and DFR was 500. DFR remained 500 till the end of the patient’s treatment at 0953. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. The treatment flowsheet dated 6/14/25 had dialysis treatment documented as started at 0626 and completed at 1000. P-3’s treatment orders indicated: duration- 210 min, BFR- 450, DFR- 800. At 0629 BFR was recorded 350 and DFR was 500. At 0723 BFR documented at 450 and DFR remained 500. At 0855 DFR documented as 0 (zero). No nursing progress/treatment note was found with explanation of BFR and DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. On 6/26/25 at approximately 0930 review of P-4 treatment sheets revealed the following documentation. The treatment flowsheet dated 6/20/25 had dialysis treatment documented as started at 1055 and completed at 1443. P-4’s treatment orders indicated: BFR- 450, DFR- 800. At 1122 BFR was recorded 350 and DFR was 600. At 1334 BFR was changed to 450 and DFR to 700 till the end of the patient’s treatment at 1443. No nursing progress/treatment note was found with explanation of BFR and DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. During the interview with facility patient care technician, Staff D, on 6/25/25 at 1115, she stated that if patient’s treatment parameters (like blood flow or dialysate rates) or the vital signs are outside of the indicated range she would notify the nurse and document in the patient’s record. On 6/26/25 at approximately 1005 the Director of operations, Staff I, was interviewed. She stated that staff nurses need to notify patient’s physician if patient’s flow rates were adjusted (outside of the order) during the treatment. Facility policy #56284 titled “Patient Assessment and Monitoring” published 5/1/2023 was reviewed and revealed: “During treatment. Follow the steps below for monitoring patient and machine parameters during treatment: Check prescribed blood flow is being achieved, or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered. Document any findings and interventions in the medical record”.”