Fresenius Kidney Care Fleet Street

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 47759 Based on the overall findings of this survey, it was determined that the facility’s governing body failed to ensure that facility Staff #1, #2, #3 and #5 operated dialysis machines in compliance with the manufacturer’s recommendations as evidenced by: 1. Failure to assemble the required safety components prior to testing as outlined in the manufacturer’s instructions. 2. Failure to adhere to the manufacturer’s troubleshooting procedures and recommended steps as outlined in the manufacturer’s instructions. and 3. Failure to remove dialysis machines from service after they failed subsequent tests, as required by the manufacturer’s instructions . These failures placed the affected patients at potential risk of serious injury, serious harm and possible death and resulted in the determination that the facility was out of compliance with the Condition for Coverage for Physical Environment (CfC: 494.60). Findings included: 1. The facility’s governing body failed to ensure that staff operated dialysis machines in accordance with the manufacturer’s recommendations. Cross Reference: Physical Environment-Safe/functional/comfortable environment (V0403)”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 47759 Based on the overall finding of the survey, it was determined that the facility’s governing body failed to ensure that staff members #9 and #10 provide timely assessments, re-assessments, and interventions for the abnormally high blood pressure values for patients #E and #F. This failure placed the affected patients at risk of serious injury, serious harm and possible death, and resulted in the finding that the facility was out of compliance with the Condition for Coverage for Plan of Care (CfC: 494.90). Findings Included: The facility ’ s governing body failed to ensure that staff members #9 and #10 provide timely assessments, re-assessments and interventions for the abnormally high blood pressure values for patients #E and #F. Cross Reference:Plan of Care-Manage Volume Status (V0543)”

“CFC-MEDICAL RECORDS CFR(s): 494.170 This Condition is not met as evidenced by: 47759 Based on the overall findings of this survey, it was determined that the facility’s governing body failed to ensure that patient E ’ s 1.) Medication order and 2.) Staff member entries were complete and accurate. These failures placed the affected patient at potential risk of harm, denied the patient their right to safe and appropriate treatment, and resulted in a determination that the facility was out of compliance with the Condition for Coverage for Medical Records (CfC: 494.170). Findings Included: The facility’s governing body failed to ensure that 1.) The medication order for Patient E, dated 06/17/2025, included the following required components: a.) Indication/Reason for the medication, b.) Time or frequency of administration, and c.) Clinical parameters for use (e.g., vital sign thresholds or symptom criteria) and 2.) failed to ensure that entries be made as soon as possible after an event or observation is made. Cross Reference: Medical Record-Complete, Accurate, Accessible (V0726)”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and record review of facility’s policies and procedures, it was determined that the facility’s governing body failed to ensure that facility staff #1, #2, #3 and #5 operated dialysis machines in compliance with the manufacturer ’ s recommendations as evidenced by: 1. Failure to assemble the required safety components prior to testing as outlined in the manufacturer’s instructions. 2. Failure to adhere to the manufacturer’s troubleshooting procedures and recommended steps as outlined in the manufacturer’s instructions. and 3. Failure to remove dialysis machines from service after they failed subsequent tests, as required by the manufacturer’s instructions . These failures placed the affected patients at potential risk of serious injury, serious harm, and possible death. Findings Included: 1. On 06/17/2025 at 02:42 p.m., during review of the facility ’ s policy titled “Priming an Optiflux Single Use E-Beam Dialyzer,” page 4 number 13 stated: “Place venous bloodline in the occluding clamp below the air detector and close optical detector door beneath occlusion clamp.” Number 14 stated: “Perform the Pressure and Alarm tests on all 2008 machines.” a. On 06/17/2025, during observations of the treatment floor, the surveyor observed the following: i. At 10:53 a.m., Staff #1 tested dialysis machine #11 located in Station #2 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). ii. At 10:54 a.m., Staff #2 tested dialysis machine #30 located in Station #7 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). iii. At 10:56 a.m., in an interview, Staff #10 stated that the staff members had previously received training on proper assembly of the machines and that there was no excuse for the non-compliance. iv. At 11:25 a.m., Staff #3 began testing dialysis machine #1 located in Station #23 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). The surveyor then observed Staff #3 insert the tubing beneath the venous drip chamber while testing without retesting the dialysis machine again. b. On 06/17/2025 at 05:10 p.m., the Office of Health Care Quality (OHCQ) issued Immediate Jeopardy #1 due to concerns for multiple staff members (Staff #1, Staff #2, and Staff #3) failure to assemble the required safety components prior to testing as outlined in the manufacturer ’ s instructions. On 06/20/2025 at 01:00 p.m., a survey team member verified that the facility implemented the acceptable IJ removal plan, which included the following actions: i. Completion of In-services to all direct patient care (DPC) staff members placing emphasis on the assembly of the required safety components prior to testing as outlined in the manufacturer ’ s instructions. ii. Completion of 100% machine audits prior to patient treatment initiation iii. Completion of daily meetings with the governing body to discuss audit results and monitor compliance. 2. On 06/18/2025 at 09:00 a.m., during review of the Fresenius 2008T Machine Operator ’ s Manual, page 208 stated that in case of an air detector alarm, the action required are as follows: “1.) Inspect the venous drip chamber and level detector module to see if: -There is an adequate level of blood (approximately ¾ full) in chamber-The venous drip chamber is properly mounted in its holder. -The venous drip chamber is positioned with the mesh filter below the level detection sensors. -The sensors are clean (if not, clean with an alcohol pad) -The Level Detector door is closed and latched. 2.) Raise blood level by pressing and holding the (up) key on the level detector until the chamber is approximately ¾ full. 3.) Press the reset key to reset the alarm. If unable to reset the alarm, return the blood to the patient and take the machine out of service. Have a qualified service technician recalibrate for the type of bloodline used.” a. On 06/18/2025 during observations of the treatment floor, the surveyor observed the following: i. At 08:11 a.m., Staff #1 reset the dialysis machine alarm-identified as “Air Detector Alarm” on Machine #26, located at Station #10 at least 5 times. The surveyor then observed Staff #1 obtain a syringe as part of troubleshooting. ii. Interviews with Staff #1 stated that the syringe was used to remove air from the venous chamber. Staff #1 then added that, instead of resetting the air detector alarm multiple times, the appropriate action would have been to pause patient treatment, troubleshoot, and reset the air detector alarm. iii. In an interview, Staff #4 stated that Staff #1 ’ s actions of resetting the alarm multiple times placed the patient at risk of harm by “sending” potential air to the patient. b. On 06/18/2025 at 10:10 a.m., the Office of Health Care Quality (OHCQ) issued Immediate Jeopardy #2 due to a concern for Staff #1 ’ s failure to adhere to the manufacturer ’ s troubleshooting procedures and recommended steps as outlined in the manufacturer ’ s instructions. On 06/20/2025 at 01:00 p.m., a survey team member verified that the facility implemented the acceptable IJ removal plan, which included the following actions: i. Completion of In-services to all direct patient care (DPC) staff members placing emphasis on adherence to the manufacturer ’ s troubleshooting procedures and recommended steps as outlined in the manufacturer ’ s instructions. ii. Completion of real-time audits of alarm troubleshooting techniques on the treatment floor and immediate correction of variances in policies and procedures. iii. Completion of daily meetings with the governing body to discuss audit results and monitor compliance. 3. On 06/23/2025 at 12:00 p.m., during review of the Fresenius 2008T Machine Operator ’ s Manual, Page 74 stated “If the machine fails this or any of the pressure, alarm, and diasafe tests and the cause cannot be corrected, or if it fails subsequent tests, do not use it for treatment. Remove the machine from service and have it inspected by a qualified technician to correct the problem.” a. Between 06/19/2025 and 06/20/2025, during observations and staff interviews, the surveyor observed the following: i. On 06/19/2025 between 10:48 a.m. -11:20 a.m.., the surveyor observed that the machine test performed on Machine #15 located at Station #19 failed the machine testing twice. The surveyor heard Staff #10 instruct Staff #5 to not use the machine and to pull the machine out of service ii. On 06/20/2025 at 06:25 a.m., the surveyor observed Machine #15 located at Station #19 failed machine testing twice again. iii. On 06/20/2025 at 09:30 a.m., interviews with Bio-Med stated that the staff members did not pull any machines on 06/19/2025. iv. Interviews with the Bio-Med and Staff #10 stated that the machine that failed twice on 06/19/2025 should have been pulled out of service per policy.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) 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- (1) At least annually for stable patients; This Standard is not met as evidenced by: 47759 Based on observations and record review, the facility’s governing body failed to ensure a comprehensive reassessment and a plan of care (PoC) was done annually for Patient E. This failure denied the patient rights to a minimum standard of care. Findings included: On 06/18/2025 at 01:00 p.m., review of the facility’s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” (Reference Number 45283) determined that page 3 stated, “Comprehensive interdisciplinary assessments and modifications to the Plan of Care (PoC) must be conducted 12 months after the completion of the 3-month assessment and then reassessed annually thereafter on all stable patients.” On 06/18/2025 at 01:10 p.m., during a review of Patient E’s plan of care, the surveyor observed that the most recent plan of care had been completed on March 21, 2024-approximately 2 to 3 months overdue.”

“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: 47759 Based on observations, record reviews and staff interviews, it was determined that the facility’s governing body failed to ensure that staff members #9 and #10 provide timely assessments, re-assessments and interventions for the abnormally high blood pressure values for patients #E and #F. This failure placed the affected patients at risk of serious injury, serious harm and possible death. Findings Included: On 06/18/2025 at 02:30 p.m., during review of the facility’s policy titled “Hypertension,” page 2 stated: - Notify the nurse in charge if a patient has a systolic blood pressure greater than 180 mm/Hg and/or diastolic blood pressure greater than 100 mm/Hg. - The RN will assess the patient and determine if further nursing interventions are needed. - Document in patient’s treatment record. 1. On 06/17/2025 at 09:44 a.m., the surveyor observed Patient E ’ s blood pressure of 222/77 mmHg. The surveyor awaited action from one of the nurses to assess the patient. At 10:06 a.m., the surveyor asked Staff #10 to see the blood pressure data trend. The data trend recorded revealed the following: -07:14 a.m: 200/73 -07:33 a.m: 209/75 -08:12 a.m: 215/79 -08:40 a.m: 213/71 -09:03 a.m: 228/84 -09:35 a.m: 227/77 -10:05 a.m: 230/85 a. On 06/17/2025 between 10:06 a.m. -10:14 a.m., the surveyor interviewed Staff #10 regarding Patient E’s blood pressure trend. According to Staff #10: i. The Blood Pressure is “very high” ii. The 2 clonidine given has “not worked” b. On 06/17/2025 at 04:50 p.m., record review of the treatment flowsheet revealed the following: i. At 07:13 a.m., Clonidine HCl 0.100 mg oral was given. ii. At 08:44 a.m., Clonidine HCl 0.100 mg oral was given. iii. No reassessment or clinical intervention by either Staff #9 or #10 was conducted until 10:06 a.m., approximately one hour and twenty-two minutes following the administration of the second dose of clonidine, at which point the surveyor intervened. iv. At 10:14 a.m., upon notification of Patient E’s condition to the provider, Staff #10 was instructed to initiate contact with emergency medical services (EMS). c. On 06/23/2025 at 12:06 p.m., interviews with Staff #10 revealed the following: i. According to staff #10, if a patient’s systolic blood pressure sustains X>180 mmHg after intervention, the staff should call the patient’s medical provider to report the finding. d. Based on Patient E’s medical record review, Patient E’s blood pressure remained X>200 mmHg for a total of 3 hours total until EMS was initiated. 2. On 06/18/2025 at 11:18 a.m., the surveyor observed Patient F with a blood pressure of 208/93 mmHg. The surveyor awaited action from one of the nurses to assess the patient. At 11:40 a.m., the surveyor observed Staff #10 attend to Patient F. a. On 06/18/2025 at 12:27 p.m., the surveyor observed the following blood pressure trend recorded on the patient ’ s hemodialysis machine: 10:55 a.m. - 216/99 10:56 a.m. - 224/100 11:02 a.m. - 223/110 11:08 a.m. - 217/96 11:16 a.m. - 208/93 11:25 a.m. - 199/109 11:37 a.m. - 214/110 11:54 a.m. - 217/102 b. On 06/18/2025 at 01:10 p.m., record review of Patient F’s treatment flowsheet revealed the following: i. At 11:46 a.m., nursing assessment documentation stated: “Lethargy.” ii. At 12:00 p.m., “EMS initiated.” c. On 06/18/2025 at 01:30 p.m., the surveyor interviewed Staff #10 regarding the steps he/she had taken to address patient F’s condition since 10:55 a.m. According to Staff #10, he/she was aware of the patient’s blood pressure of 216/99 as well as the blood pressure that resulted after that. i. No reassessment or clinical intervention by Staff #10 was conducted until 11:40 a.m., approximately 45 minutes after the initial elevated blood pressure reading of 216/99 mmHg taken at 10:55 a.m. d. On 06/23/2025 at 12:06 p.m., according to staff #10, if a patient’s systolic blood pressure sustains X>180 mmHg after interventions, the staff should call the patient’s medical provider to report the finding. e. Based on Patient F’s medical record review, Patient F’s blood pressure was retaken repeatedly after the first result at 10:55 a.m. and remained X>199 for a total of 45 minutes until provider notification has been made and EMS initiated 3. On 06/18/2025 at 09:05 p.m., the Office of Health Care Quality (OHCQ) issued Immediate Jeopardy #3 due to concerns for Staff members #9 and #10 failure to provide timely assessments, re-assessments and interventions for the abnormally high blood pressure values for patients #E and #F. On 06/23/2025 at 03:45 p.m., survey team members verified that the facility implemented the acceptable IJ removal plan, which included the following actions: a. Completion of In-services for all Patient Care Technicians placing emphasis on i. “If a patient has a systolic blood pressure greater than 180 mm/Hg and/or diastolic blood pressure greater than 100 mm/Hg: 1. Patient Care Technicians will notify the RN immediately. 2. The Registered Nurse will assess the patient and determine if further nursing interventions are needed.” b. Completion of In-services for all Registered Nurses placing emphasis on i. “The RN will notify the physician as needed and document any new orders given ii. All interventions will be documented in the patient’s treatment record. iii. The RN conducts reassessments and or updates clinical interventions timely” c. Completion of 100% patient blood pressure audits on the treatment floor and immediate correction of variances in policies and procedures. d. Completion of daily meetings with the governing body to discuss audit results and monitor compliance.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and a review of the facility ’ s policies and procedures, it was determined that the facility ’ s governing body failed to ensure that 1.) The medication order for Patient E, dated 06/17/2025, included the following required components: a.) Indication/Reason for the medication, b.) Time or frequency of administration, and c.) Clinical parameters for use (e.g., vital sign thresholds or symptom criteria); and 2.) Failed to ensure that entries be made as soon as possible after an event or observation is made. These failures placed patients at potential risk of harm and denied the patient their right to safe and appropriate treatment. Findings Included: 1. On 06/23/2025, at 04:00 p.m., during review of the facility ’ s policy titled “Medication Preparation and Administration” Reference number 47488, page 3 stated, “Follow the principles below for medication preparation and administration: -Right Drug -Right Dose -Right Route -Right Time -Right Patient -Right Documentation (Right Reason) (Right Response).” a. At 12:35 p.m., review of Patient E ’ s “treatment medication” stated: “Clonidine HCl 0.1 mg oral prn-may repeat x1.” The order lacked the following elements: 1.) The reason for administration, 2.) The parameters indicating when the medication should be given, and 3.) The specific frequency or time interval between doses. b. At 12:37 p.m., interviews with Staff #10, the clinical coordinator, confirmed that, based on the order above, Staff #10 will use his/her judgement 1.) When to administer Clonidine HCl 0.1 mg and 2.) When the second dose of Clonidine HCl 0.1 mg may be given again. 2. On 06/23/2025, at 04:30 p.m., review of the facility ’ s policy titled “Medical Record Documentation Standards” Reference Number 46940 determined that page 2 stated, “Entries should be made contemporaneously or as soon as possible after an event or observation is made.” a. On 06/17/2025 at 04:50 p.m., during review of Patient E ’ s treatment flowsheet, the surveyor observed the following: i. At 07:13 a.m., Clonidine HCl 0.1 mg was documented as administered to Patient E. 1. The corresponding documentation of reassessment was not logged until 01:41 p.m. ii. At 08:44 a.m., Clonidine HCl 0.1 mg was documented as given to Patient E. 1. The corresponding documentation of reassessment was not logged until 01:41 p.m. iii. At 10:37 p.m., Patient E ’ s treatment was documented as ended. 1. Provider notification and list of important events were not documented until 01:52 p.m.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 47759 Based on record review, patient interviews and staff interviews, the facility’s governing body failed to ensure an adequate number of qualified and trained staff to meet the needs of the patients. This failure placed the patients at potential risk and denied their rights to a minimum standard of medical care. Findings Included: The Code of Maryland Regulations 10.05.04.06C (Dialysis Monitoring for Freestanding Kidney Dialysis Centers) states:... C. Dialysis Monitoring. (1) Staffing Ratio. (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients .... (c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. ... (2) Staffing Exception Reporting. (a) The center shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum:(i) The date and shift of the exception; (ii) A description of the emergency staffing situation, (iii) Actions taken in response; and (iv) Any measures taken to ensure the center’s future compliance. ... 1. On 06/17/2025, at 03:00 p.m., during record review, the surveyor observed that the facility failed to meet the minimum patient ratio on the following dates: a. 04/14/2025, 05/16/2025, 05/19/2025, 06/02/2025, 06/10/2025, 06/14/2025. 2. On 06/19/2025, interviews with staff members revealed the following a. According to anonymous staff #1, #2, #3, and #4, the facility has experienced periods of short staffing over the past three months. During these times, according to the staff members interviewed, the patient to staff ratio becomes 4:1. According to anonymous staff #1, this level of staffing makes it difficult for the staff members to monitor vital signs and ensure that the next group of patients begins treatment on time. b. The information provided by anonymous staff #1 was supported by statements provided by anonymous patients #1 and #2 who reported instances of short staffing, instances of delays in treatment start time, and instances of delayed response to machine alarms. 3. On 06/23/2025, the surveyor requested the staffing exception reports for the past three months; however, the team leader and Staff #10 were unable to provide them.”

“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: 44367 Based on review of the facility’s documents and interviews with the Facility Administration and the Clinical Coordinator, the facility administrator and medical director failed to ensure staff members did not present to the facility when experiencing symptoms of COVID-19 and to ensure that the staff did not return to work as stated in its own policy. This failure placed the welfare and safety of patients, staff and visitors at risk of harm. Review on 04/21/2025 of the facility’s policy entitled, “Guidelines Dialyzing and Infection Control Practices of COVID-19 in Fresenius Kidney Care (FKC) Dialysis” revealed that “Staff should report symptoms of COVID-19 to their manager and be directed to stay home and not report to work when they are ill.” The policy also revealed that when staffing shortages are not anticipated and the staff member is “symptomatic: At least 24 hours have passed since fever without use of fever reducing medication, and improvement in respiratory symptoms, and at least 10 days have passed since the positive diagnosis.” The policy also states that if the facility anticipates staffing shortages and the staff member is “asymptomatic or mildly symptomatic: return to work after 5 days, recommended to wear an N95 respirator until 10 days have passed since the onset of symptoms or date of first exposure.” 1. On 04/21/2025, an interview with the Facility Administrator (FA) and the Clinical Coordinator (CC) and review of the facility’s documents revealed that on 03/12/2025, PCT #1 presented to the facility and provided direct patient care while displaying symptoms of COVID-19 without wearing a mask. According to the FA, the Clinical Coordinator informed him/her that PCT #1 showed signs and symptoms of COVID-19. After the CC reported the symptoms, PCT #1 then self-reported the signs and symptoms of COVID to the FA. The FA stated that PCT #1 was then informed to wear a mask and instructed to leave and get tested for COVID-19. The surveyor asked the FA why did PCT #1 come to work if he/she was not feeling well, but no answer was provided. The FA stated that he/she asked PCT #1 the same question. On 03/12/2025, PCT #1 did test Positive for COVID-19 and was instructed not to return to work. The FA stated that PCT #1 returned to work on 03/16/2025 after providing a negative test result. PCT #1 returned to work 4 days after testing positive. PCT #1 returned to work before the time the policy states. The Facility Administrator corroborated that PCT #1 was displaying signs and symptoms of COVID-19 and providing direct patient care without wearing a mask; and that PCT #1 was allowed to return to work against the facility’s policy.”