Fkc Milford

“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: 51624 Based on observation, policy review, and staff (EMP) interview, the facility failed to provide a sanitary environment to minimize the transmission of infectious agents, with the potential to impact all 72 in-center patients and 35 home therapy patients receiving treatment from the facility. Findings include: Review of the Facility policy “Medication Preparation and Administration” dated 07/07/2025, Version 10, revealed, “...Monitoring Expired Medications...Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law...” Review of the Facility policy “Storage of Supplies” dated 11/03/2025, Version 3, revealed, “...Appropriately dispose of items that have reached the expiration date...Environmental Storage Conditions: All supplies must be stored in a clean, well lit, and climate-controlled environment...Supplies will be discarded when: Product expires...” I. During an environmental tour on 12/15/2025 of the in-center hemodialysis treatment floor between 9:25 and 11:01 AM, the following was observed. - Twenty-nine 250 mL Baxter 0.9% Sodium Chloride, Lot V24E08K, expired 11/2025, stored within a black cabinet labeled IV supplies alongside unexpired supplies. This product is intended to replenish fluids and electrolytes in patients undergoing dialysis. This finding was confirmed with EMP7 at the time of discovery and again at 10:52 AM by EMP14, who removed the expired supplies from the unit. - One box of Vifor Pharma MIRCERA 30 mcg/0.3 mL, Lot B2500H03, expired 10/2023, in the medication refrigerator. This product is intended to treat anemia. The box was found at the bottom of the refrigerator; its exterior was wet, sticky, and coated in a brown residue. - One dead fly was observed in front of the MIRCERA box at the time of discovery. During an interview on December 15, 2025, at 10:52 AM, EMP14 confirmed the findings and revealed that supplies are received by the secretary and stocked by nurses. EMP14 also confirmed that the bottom of the refrigerator had not been cleaned and removed the soiled expired MIRCERA box from the unit. II. During an environmental tour on 12/16/2025 of the home dialysis training center between 8:56 AM and 9:20 AM, the following was observed. - Home training room 3 contained one (1) bottle of Pure Bright Germicidal Ultra Bleach, Lot 251065302, expired 11/30/25. This was confirmed with EMP9 at the time of discovery, who disposed of the bottle and replaced the item.”

“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: 51624 Based on observation, policy review, and staff (EMP) interview, the facility failed to ensure the salt level in the brine tank (a plastic container that holds salt pellets and produces a brine solution) was at least half full, which is necessary to ensure sufficient concentrated sodium-rich salt solution for regeneration, needed to prevent scaling to reverse osmosis membranes. This failed practice had the potential to compromise the safety of all 72 in-center hemodialysis patients receiving treatment at this facility. Findings include: Facility policy titled “Water Softener Policy”, dated 05/05/2025, Version 7 revealed, “...Salt levels inside brine tanks will be maintained at a minimum of half full...” During an environmental tour of the water treatment area on 12/15/2025, between 12:11 and 12:33 PM, the salt brine tank was observed to be approximately one-quarter full of salt pellets. This finding was confirmed by EMP2 and EMP15 at the time of discovery.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 51624 Based on observation, policy review, and staff (EMP) interview, the facility failed to maintain the integrity of the wall and floor surfaces of the in-center patient treatment areas. Failure to maintain the integrity of these surfaces allows rust and grime to accumulate, rendering them porous and unable to be properly disinfected. This failure creates a patient safety hazard and could negatively affect all 72 in-center hemodialysis patients at this facility. Findings include: Facility policy titled “Quality Assessment and Performance Improvement Program”, dated 11/04/2024, Version 6, revealed, “...Technical Services Representative is responsible for: Reporting on technical related issues, including water and dialysate quality, equipment maintenance and physical plant issues...” Review of the Facility policy “Cleaning the Dialysis Treatment Area and Isolation Area Procedure” dated 09/02/2025, Version 4, revealed, “...The isolation room should be cleaned last if the facility has one...Use only the cleaning equipment identified for the isolation room...Perform sweeping operation with the damp mop head...” During an environmental tour of the in-center hemodialysis unit on 12/15/2025, between 9:25 and 11:01 AM, the following observations were made: - Wall guard in front of patient care station 16 was partially disassembled and not sealed smoothly to the wall. - The integral cove bases in front of patient care stations 1, 2, 12, and 16 were separated from the wall, breaking the floor-to-wall seal. This prevents the facility from effectively disinfecting the floors and walls, creating an additional space for grime to accumulate. - In the isolation room, the base of the floor-mounted PDI television screen, model PDI-405C-10, serial number 986310, had rusted to the floor. Bugs, cobwebs, and debris were found connected from the floor-mounted base of the PDI screen to the bottom, back-left wall corner. - The corner of the wall next to patient care station 22 was cracked and chipped, displaying signs of impact damage from the movable PDI screen. - The wall guard next to the patient handwashing station before exiting the unit was separating and not sealed to the wall. These findings were confirmed by EMP7 on 12/25/2025, between 10:29 and 10:39 AM, and EMP14 between 10:52 and 11:01 AM.”

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 51624 Based on observation, policy review, and staff (EMP) interview, the facility failed to provide enough separation between the hemodialysis stations and the clean handwashing sinks, which is necessary to prevent cross-contamination of the clean sinks. This failure creates lapses in infection prevention and could negatively affect all 72 in-center hemodialysis patients at this facility. Findings include: Review of the Facility policy “Dialysis Precautions” dated 01/04/2012, Version 4, revealed, “...Approach...all supplies and equipment used for a patient’s treatment as if...they are contaminated...Clean area: an area designed 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 handed...Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored...” During an environmental tour of the in-center hemodialysis unit on 12/15/25 between 9:25 and 11:01 AM, the following observations were made: - A sink labeled clean handwashing sink was directly next to a hemodialysis treatment station, with no separation between the clean sink countertop and the hemodialysis treatment station. This finding was confirmed with EMP7 between 10:29 and 10:39 AM, and by EMP14 between 10:52 and 11:01 AM.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47821 Based on policy review, medical record (MR) review, and staff (EMP) interview, the facility failed to ensure that the dialysis prescription was followed as ordered for 1 out of 18 (PT16) in-center hemodialysis patients sampled. Findings include: Review of the Facility policy “Patient Monitoring and Safety Checks During Hemodialysis Treatment” dated 9/5/2023, revealed, “...Responsibility...Inpatient Services Registered Nurse (RN)...Patient Care Technician (PCT)...Verify....DFR [dialysate flow rate] is set and functioning per treating physician order...” Review of MR16 revealed: - “Dialysis Orders” dated 12/2/2025, revealed a prescription for DFR of 800 mL/min. The DFR is the rate at which the cleansing fluid (dialysate) flows through the dialyzer, typically measured in mL/min, with values ranging from 500 to 800 mL/min. - “Treatment Data” dated 12/2/2025, documented that the hemodialysis treatment ran with a DFR of 500 ML/min from 11:37 AM to the end of treatment at 3:18 PM. - “Treatment Data” dated 12/4/2025, documented that the hemodialysis treatment ran with a DFR of 500 ML/min from 11:01 AM to the end of treatment at 3:04 PM. - “Treatment Data” dated 12/11/2025, documented that the hemodialysis treatment ran with a DFR of 500 ML/min from 11:01 AM until 1:07 PM. There was no evidence in the medical record explaining why the prescribed DFR was not followed for the above treatments. During an interview on December 18, 2025, between 2:27 and 3:00 PM, EMP1 confirmed these findings.”

“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: 47821 Based on policy review, medical record (MR) review, and staff (EMP) interview, the facility failed to provide management of volume status as evidenced by not addressing high patient blood pressure readings during treatment for 4 out of 18 (PT3, PT10, PT15, and PT16) in-center hemodialysis patients sampled. Findings include: Facility document “AD HOC [for a particular purpose only] GOVERNING BODY MEETING” dated February 18, 2025, revealed, “...The Chairperson directed the attention of the members to the Reportable Parameters to Report to the RN [Registered Nurse] for the Fresenius Medical Care Milford Facility...PCT [Patient Care Technician]...Report to RN Pre-Treatment...B/P [blood pressure] ...Diastolic > [greater than] 110...RN will report to provider prior to starting treatment when above parameters are out of range...PCT...Report to RN Intra-dialysis [during treatment]...B/P...Systolic >200...Diastolic >110...RN will report to provider out of range B/P...PCT...Report to RN post dialysis...B/P... Diastolic >110...RN will report out of range parameter to provider.... After the discussion and review of the above Facility Mandated Reportable Parameters that will be reported to the RN, the Board unanimously approved the recommendation...” Facility job description “PCT I” dated 7/12/2022 revealed, “...PRINCIPAL DUTIES AND RESPONSIBILITIES...Patient Related...Treatment...Report any significant information and/or change in patient condition directly to the registered nurse...” MR3: “Treatment Sheet” dated 12/4/2025 for treatment that started at 10:47 AM revealed: - At 11:32 AM, “...BP 173/116...Patient Alert...” Signed by EMP13, PCT. - At 12:35 PM, “...BP 172/120... Patient Alert...” Signed by EMP13. - At 1:04 PM, “...BP 177/122....” Signed by EMP13. - At 1:32 PM, “...BP 170/119...” Signed by EMP13. - At 2:00 PM, “...BP 164/118...Denies Complaints....Patient Alert...” Signed by EMP10, PCT. - At 2:32 PM, “...BP 161/113...” Signed by EMP13. - The 3:04 PM, “...BP 156/111...Patient Alert...Treatment Discontinued...” Signed by EMP13. - EMP16’s post-treatment nursing evaluation dated 12/4/2025 at 3:20 PM stated,”...Treatment completed and tolerated well, pt [patient] denies pain/discomfort; CVC [central venous catheter] patent, intact, covered and secured; pt d/c [discharged] stable...” - There is no evidence in the medical record that the PCTs notified the RN of the diastolic blood pressures greater than 110 or that the RN notified the provider of the elevated diastolic blood pressures. “Treatment Sheet” dated 12/8/2025 for treatment that started at 6:11 AM revealed: - At 6:32 AM, “...BP 174/115...Denies Complaints...Patient Alert...” Signed by EMP17, PCT. - At 7:32 AM, “...BP171/115...” Signed by EMP17. - At 8:31 AM, “...BP 165/115...” Signed by EMP17. - At 9:02 AM, “...BP 169/111...” Signed by EMP6, RN Charge Nurse. - At 9:32 AM, “...BP 173/114...Access Visible...Denies Complaints...” Signed by EMP17. - EMP6’s post-treatment nursing evaluation dated 12/8/2025 at 11:04 AM stated, “Post Tx [treatment]-Tx tolerated, no complaints post Tx, A & O [alert and oriented], catheter capped and dressed, ambulated out of clinic...” - There is no evidence in the medical record that the PCT notified the RN of the diastolic blood pressures greater than 110 or that the RN notified the provider of the elevated diastolic blood pressures. “Treatment Sheet” dated 12/10/2025 for treatment that started at 6:29 AM revealed: - At 6:29 AM, “...BP 160/116...Denies Complaints; Patient Alert; Started...” Signed by EMP18, RN. - At 6:35 AM, “...BP 165/114...Denies Complaints...Access Visible...” Signed by EMP18. - EMP18’s post-treatment nursing evaluation dated 12/10/2025 at 12:29 PM stated, “...Txt [treatment] tolerated well. Slept during txt. Denies pain/discomfort. Cath intact, patent, taped and secured. Txt reviewed. D/c stable amb [ambulation] and steady...” - There is no evidence in the medical record that the RN notified the provider of the elevated diastolic blood pressures. These findings were confirmed with EMP1 during an interview on December 16, 2025, between 9:28 and 9:48 AM. MR10: “Treatment Sheet” dated 12/3/2025 for treatment that started at 7:07 AM revealed: - At 8:00 AM, “...BP 158/118...Denies Complaints...Patient Alert...” Signed by EMP19, PCT. - EMP20’s post-treatment nursing evaluation dated 12/3/2025 at 11:25 AM stated, “...RN evaluation-No Unusual Findings noted...stable, no s/s [signs or symptoms] of distress noted, offers no complaints...” - There is no evidence in the medical record that the PCT notified the RN of the diastolic blood pressure greater than 110 or that the RN notified the provider of the elevated diastolic blood pressure. “Treatment Sheet” dated 12/12/2025 for treatment that started at 7:10 AM revealed: - At 8:03 AM, “...BP 175/111...Patient Alert...Denies Complaints...” Signed by EMP10, PCT. - EMP1’s post-treatment multidisciplinary note dated 12/12/2025 at 1:03 PM stated, “Post treatment patient out of unit with no noted problems. Catheter capped and secure patient d/c to home...” - There is no evidence in the medical record that the PCT notified the RN of the diastolic blood pressure greater than 110 or that the RN notified the provider of the elevated diastolic blood pressure. “Treatment Sheet” dated 12/15/2025 for treatment that started at 7:07 AM revealed: - At 11:03 AM, “...BP 147/120...” Signed by EMP21, PCT - EMP18’s post-treatment nursing evaluation dated 12/15/2025, at 1:18 PM stated, “...Txt tolerated well. Denies pain/discomfort. Cath intact, patient, taped and secured. Txt reviewed. D/c stable amb and steady...” - There is no evidence in the medical record that the PCT notified the RN of the diastolic blood pressure greater than 110 or that the RN notified the provider of the elevated diastolic blood pressure. These findings were confirmed with EMP1 during an interview on December 18, 2025, between 2:27 and 3:00 PM. MR15: “Treatment Sheet” dated 11/25/2025 for treatment that started at 8:55 AM revealed: - At 11:32 AM “...BP 202/97...” Signed by EMP22, RN. - EMP7’s post-treatment nursing evaluation dated 11/25/2025 at 2:34 PM stated, “...post tx [treatment], tol [tolerated] her tx, needles pulled, access taped/secured, pos bruit/thrill over RAVG [right arteriovenous graft], bp stable...” - There is no evidence in the medical record that the RNs notified the provider of the elevated systolic blood pressure. This finding was confirmed with EMP1 during an interview on December 18, 2025, between 2:27 and 3:00 PM. MR16: “Treatment Sheet” dated 11/27/2025 for treatment that started at 11:16 AM revealed: - At 12:37 PM, “...BP 137/115...” Signed by EMP19, PCT. - EMP7’s post-treatment nursing evaluation dated 11/27/2025 at 3:49 PM stated, “...post tx, tol her tx, cvc heparinized, ports remain capped/clamped/taped/secured, bp stable...” - There is no evidence in the medical record that the PCT notified the RN of the diastolic blood pressure greater than 110 or that the RN notified the provider of the elevated diastolic blood pressure. These findings were confirmed with EMP1 during an interview on December 18, 2025, between 2:27 and 3:00 PM.”

“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: 47821 Based on document review, observation, medical record (MR) review, and staff (EMP) interview, the facility’s Medical Director failed to ensure that treatment orders followed the Governing Body-approved reportable vital signs parameters for 3 of 18 (PT15, PT22, and PT23) in-center hemodialysis patients sampled. Findings include: Facility document “AD HOC [for a particular purpose only] GOVERNING BODY MEETING” dated February 18, 2025, revealed, “...The Chairperson directed the attention of the members to the Reportable Parameters to Report to the RN [Registered Nurse] for the Fresenius Medical Care Milford Facility...PCT [Patient Care Technician]/CCHT [Certified Clinical Hemodialysis Technician]...Report to the RN Pre-Treatment...B/P [blood pressure] Systolic >200 or <90 &/Or Diastolic >110...Pulse <45 or >115 beats per minute...PCT/CCHT...Report to the RN Intra-dialysis [during treatment]...B/P Systolic >200 or <90 &/Or Diastolic >110...Pulse <45 or >115 beats per minute...After the discussion and review of the above Facility Mandated Reportable Parameters that will be reported to the RN, the Board unanimously approved the recommendation...” During an interview on December 16, 2025, at 9:28 AM, EMP1 stated that the unit adheres to the Facility Mandated Reportable Parameters for registered nurses (RNs) as approved by the Governing Body on 2/18/2025. These parameters are B/P Systolic >200 or <90 &/OR Diastolic >110, Pulse <45 or >115 BPM (beats per minute). PT15 - During an observation on 12/18/2025 between 9:03 and 9:16 AM, when asked by the surveyor, “What vital sign parameters do you report to the RN?” EMP12 referred to the patient orders in PT15’s machine, which documented “Special Attentions Per Clinic Policy: Reportable Parameters to RN/MD [medical doctor] B/P Systolic >200 or <90 &/OR Diastolic >100 Pulse <45 or >115 BPM.” - Review of PT15’s “Treatment Sheet” dated 12/18/2025 for treatment that started at 9:01 AM and ended at 1:07 PM, documented a physician order for “...Special Attentions...Per Clinic Policy: Reportable Parameters to RN/MD B/P Systolic >200 or <90 &/Or Diastolic >100 Pulse <45 or >115 BPM...” PT22 - During an observation on 12/18/2025 between 9:03 and 9:16 AM, when asked by the surveyor, “What vital sign parameters do you report to the RN?” EMP11 referred to the patient orders in PT22’s machine, which documented “Special Attentions Per Clinic Policy: Reportable Parameters to RN/MD B/P Systolic >200 or <90 &/OR Diastolic >100 Pulse <45 or >115 BPM.” - Review of PT22’s “Treatment Sheet” dated 12/18/2025 for treatment that started at 7:38 AM and ended at 11:41 AM, documented, “...Special Attentions...Per Clinic Policy: Reportable Parameters to RN/MD B/P Systolic >200 or <90 &/Or Diastolic >100 Pulse <45 or >115 BPM...” PT23 - During an observation on 12/18/2025 between 9:03 and 9:16 AM, when asked by the surveyor, “What vital sign parameters do you report to the RN?” EMP13 referred to the patient orders in PT23’s machine, which documented “Special Attentions Per Clinic Policy: Reportable Parameters to RN/MD B/P Systolic >200 or <90 &/OR Diastolic >100 Pulse <45 or >115 BPM.” - Review of PT23’s “Treatment Sheet” dated 12/18/2025 for treatment that started at 6:48 AM and ended at 11:19 AM, documented, “...Special Attentions...Per Clinic Policy: Reportable Parameters to RN/MD B/P Systolic >200 or <90 &/Or Diastolic >100 Pulse <45 or >115 BPM...” During an interview on December 18, 2025, between 2:27 and 3:00 PM, EMP1 confirmed these findings and that the Special Attentions Per Clinic Policy: Reportable Parameters to RN/MD referenced in the patient orders for PT15, PT22, and PT23 did not reflect the Facility Mandated Reportable Parameters to the RN that was approved by the Governing Body on 2/18/2025.”