Fmc of Forest Park

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 30377 Based on observation, record review, and staff interview, the facility’s staff failed to: A. ensure their hands were washed or sanitized between glove changes, when moving from station to station, and after touching patients per facility policy. (Cross Reference to Tag V0113) B. to appropriately label prepared medications with the time and initials of the person who prepared the medication. (Cross Reference to Tag V0117) C. ensure all patients (pt) susceptible to Hepatitis B had a monthly Hepatitis B Antigen (Ag) drawn (Cross Reference to Tag V0124) D. ensure expired supplies were discarded on or before the expiration date and not available for patient use in the facility. (Cross Reference to Tag V0142) These findings have the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by increasing the potential of cross-contamination between patients.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 30377 Based on observation, record review, and staff interview, the Medical Director failed to ensure that facility staff: A. Ensure their hands were washed or sanitized between glove changes, when moving from station to station, and after touching patients per facility policy. (Cross Reference to Tag V0113) B. Ensure the vascular access was visible during treatment on 2 out of 20 patient observations. (Cross Reference to Tag V0407) C. Ensure a properly executed informed consent for hemodialysis treatment was completed by a licensed professional (Nurse, LMSW or RDLD) prior to treatment initiation within the facility. (Cross Reference to Tag V0451) D. Ensure that the direct patient care staff reported significant changes in patient health status while receiving hemodialysis to the charge nurse and or the charge nurse failed to reassess the patient when significant changes occurred during treatment. (Cross Reference to Tag V0504) E. Ensure that the Registered Nurse (RN) conduct the initial nursing assessment on the date of admission prior to the treatment start time. (Cross Reference to tag V0715)”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 50181 Based on observation and interview, the facility’s staff failed to ensure the dialysis orders were updated monthly in the emergency evacuation box and that there were no expired supplies in the evacuation box/crash cart. Findings included: During a tour of the facility with personnel #1 on 11/14/2024, it was observed that the emergency evacuation box/crash cart had expired hand sanitizer and the emergency disaster binder with dialysis orders for all patients had not been updated for the following months: June 2024 August-October 2024 The above findings were confirmed by personnel #1 during the review on 11/14/2024.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 30377 Based on direct observation and policy review the staff failed to ensure their hands were washed or sanitized between glove changes, when moving from station to station, and after touching patients per facility policy. These findings have the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by increasing the potential of cross-contamination between patients. Findings: Review of facility policy titled Hand Hygiene stated the following: Below identifies when hands shall be washed: o Before and after direct contact with patients o Entering and leaving the treatment area o Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications o Immediately after removing gloves o After contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled. o After contact with inanimate objects near the patient o When moving from a contaminated body site to a clean body site of the same patient o After contact with other objects within the patient station or treatment space During observation of care of the facility’s in-center treatment area on 11/12/2024 the following was observed: At 10:40 am: The registered nurse staff member #16 was observed gloved placing blue pad under dialysis catheter limbs, opening clean supplies at chair side, cleaning catheter ports, removing port caps and removing approximately 5 cc of blood and then flushing the catheter port. He than removed and disposed of the gloves and walked to the counter that contained a box of clean gloves. He then preceded to place on a new pair of gloves. The registered nurse did not perform hand hygiene after touching the patient, prior to exiting station, and or after gloves were removed. To note: The registered nurse and the patient did not have their face mask covering their nose while dialysis catheter was being accessed. At 10:58 am: The registered nurse staff member # 16 was observed gloved rinsing back a patient with a dialysis catheter. Once rinse back was completed the registered nurse removed and disposed of the gloves and walked to the clean counter that contained a box of clean gloves. He then proceeded back to the patient’s chairside to document on the computer. The registered nurse did not perform hand hygiene after touching the patient, prior to exiting station, and or after gloves were removed In an interview conducted, with the Clinical Manager, on 11/12/24 at 11:00 a.m. confirmed that staff were required to wash or sanitize hands between glove changes, when moving from station to station, and after touching patients to prevent cross contamination.”

“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: 50181 Based on observation and interview, it was determined that the facility staff failed to appropriately label prepared medications with the time and initials of the person who prepared the medication. During a tour of the facility’s in-center treatment area on 11/12/2024 with Staff # 1, the surveyor observed medications prepared by the staff without the time and initials of the person who prepared the medication. Staff #1 confirmed and acknowledged the above findings during the tour of the in-center treatment area on 11/12/2024.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 30377 Based on facility policies and procedures, medical record review, and staff interview the facility failed to identify the patients’ HBV serological status monthly on patients that were susceptible to Hepatitis B virus. This deficient practice has potential to cause harm to all patients and staff who have negative anti-HBs. Findings included: A review of facility policy titled “Patient Hepatitis Testing Requirements” stated Hepatitis B laboratory testing is required for all patients based upon immunity status. Susceptible Anti-HBs less than 10 mlU/ml requires monthly testing. Review of the facility’s Hepatitis Summary Report date range from June 2024 to current revealed the following: Patient # 1 with <10 Hepatitis B Surface antibody did not have a Hepatitis B Antigen drawn for the month of October 2024. The last Hepatitis B Antigen drawn was September 12, 2024. The result was negative. An interview conducted with (Staff #1) on 11/13/24 confirmed and acknowledged the above findings following her own review.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 50181 Based on observation and staff interview during a facility tour on 11/12/2024 the facility failed to ensure expired supplies were discarded on or before the expiration date and not available for patient use in the facility. Findings included: During a tour of the facility treatment floor on the morning of 11/12/2024, the following expired supplies were found and available for patient use: *Hand sanitizer with an expiration date of 10/2022 *Health Guard Antibacterial Soap x 2 in the isolation room with an expiration date of 11/2022 *Mesa Lab Standard Solution located in the Tri-Station with an expiration date of 11/10/2024 *Open bottle of Embrace Pro Glucose Test Strips without notation of when it was opened resulting in the inability to know if it had been opened greater than 4 months after first opening *Open bottle of Embrace Pro Glucose Control Solution without notation of when it was opened resulting in the inability to know if it had been opened greater than 3 months after first opening In an interview with the Clinic Manager (Staff #1) on 11/12/2024 she confirmed the supplies were expired and still available for patient use/testing and discarded when the findings were reported.”

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 50181 Based on observation and interview, the facility failed to ensure that the wall boxes (dispensing outlets) at the dialysis stations were properly disinfected between each patient treatment and at the end of each treatment day. This deficient practice has the likelihood to cause bacterial growth in the wall boxes increasing the risk of transmission of infection to all patients treated within the facility. Findings included: During a tour of the facility treatment floor on the morning of 11/12/2024 the wall boxes were noted to have a crusted, white sediment and build-up around the connectors of the wall box. The following stations were identified as having crusted, white sediment and build-up: Station #7 Station #15 Station #16 Station #17 Station #18 Station #24 The Clinic Manager (Staff #1) confirmed the findings noted on the wall boxes on the treatment floor during the tour on 11/12/2024.”

“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: 50181 Based on observation and interview, the facility staff failed to maintain all equipment. Hemodialysis machines with degradation of the outer coating of paint were identified on the treatment floor. The degradation of the outer coating decreases the effectiveness of cleaning and disinfection between patients. These findings have the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by increasing the potential of cross-contamination between patients. Findings included: On 11/12/2024 the surveyor and Staff #1 conducted a tour of the treatment floor observing machine #8, machine #11, machine #19, machine #21 and machine #24 with damage to the outer coating of paint on the machines not allowing for effective cleaning and disinfection of the machines between use. During the tour, Staff #1 verified and acknowledged the above findings reporting all machines were repainted after the March 2024 complaint survey was conducted but would report to the technical department the need for further touch-ups. Staff #17 and Staff #4 acknowledged and verified the findings and initiated a plan to complete the repairs.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 50181 Based on observation and staff interview, the facility’s direct patient care (DPC) staff failed to ensure the vascular access was visible during treatment on 2 out of 20 patient observations. Ensuring proper visualization of the arteriovenous fistula access, arteriovenous graft access and Central Venous Catheter (CVC) is important for the early recognition and prevention of bleeding from the patient’s access site. In review of the facility’s incident reports there was a noted needle dislodgement in the facility on 05/16/2024 resulting in a hospital transfer for patient #16. During a tour of the facility’s in-center treatment area on the morning of 11/12/2024 with Staff # 1, the surveyor observed patients receiving dialysis treatment at the following stations with their access covered: Station #22 and #24. The surveyor observed the patient’s access covered for more than 10 minutes without any intervention from the direct care staff. This was reported to Staff #1 and above observations were confirmed. Staff #1 discussed findings with each DPC staff caring for the patients and the access was uncovered after findings noted.”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 50181 Based on record review and staff interview, the facility failed to ensure a properly executed informed consent for hemodialysis treatment was completed by a licensed professional (Nurse, LMSW or RDLD) prior to treatment initiation within the facility. Findings include: A review of patient # 1’s medical records revealed the patient was admitted to the facility on 09/12/2024 for hemodialysis treatment. Patient # 1 signed the “Dialysis Consent Form” on 09/12/2024. The consent indicates it was witnessed and reviewed with the patient by Staff #9 (Administrative Assistant). A review of patient # 3’s medical records revealed the patient was admitted to the facility on 09/10/2024 for hemodialysis treatment. Patient # 3 signed the “Dialysis Consent Form” on 09/10/2024. The consent indicates it was witnessed and reviewed with the patient by Staff #9 (Administrative Assistant). In an interview with Staff #1 and Staff #9 on 11/12/2024 the above findings were confirmed and acknowledged.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 50181 Based on record review and interview, it was determined that the facility failed to provide evidence of patient participation in the facility’s care plan process. Patients have the right to know about and participate in their care and treatment to the extent they desire. A review of the policy titled; “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/2023 revealed the following: “The following are recommendations for involving the patient in the development and review of the plan of care: *Provide appropriate patient education to enable to patient to participate in the development of the Plan of Care *Encourage both patients and family to participate in the Plan of Care discussions in whatever format the facility and attending physician develop *Notify the patient in writing of the time and date of the Plan of Care review *Review expectations for participation in the Plan of Care with each patient *Review the expectations again when Rights and Responsibilities are reviewed” Findings include: A review of the plan of care invites revealed there was no date documented indicating the invite was provided to the patient prior to the meeting date and their preference of chairside side meeting with the IDT, private meeting with the IDT or choosing not to attend was not selected. Patient #4: Plan of Care Meeting invite indicates the meeting will be held 05/23/2024, no time of meeting entered. Patient selection of meeting preference (chairside, private, not attending) not selected. Date invite provided to patient not noted. Plan of Care Meeting invite indicates the meeting will be held 06/15/2023, no time of meeting entered. Date invite provided to patient not noted. Plan of Care Meeting invite indicates the meeting will be held 05/09/2023, no time of meeting entered. Date invite provided to patient not noted. Patient #5: Plan of Care Meeting invite indicates the meeting will be held 11/29/2023, no time of meeting entered. Patient selection of meeting preference (chairside, private, not attending) not selected. Date invite provided to patient not noted. An interview with Staff #1 on 11/13/2024 confirmed the lack of evidence that the patients were being invited to attend an IDT (Interdisciplinary Team) in advance to decide to attend the meeting and discuss their Plan of Care.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 30377 Based on review of facility policy, hemodialysis flow sheets, and staff interview the facility failed to ensure that the direct patient care staff reported significant changes in patient health status while receiving hemodialysis to the charge nurse and or the charge nurse failed to reassess the patient when significant changes occurred during treatment. The findings included: A review of the facility policy, “Reportable by Direct Patient Care Staff to Charge Nurse.” Revealed that the following parameters were provided for the direct patient care staff to give guidance when a registered nurse needed to evaluate the patient status. Fluid Status: No weight gain, negative gain or weight gain >4 kgs Blood Pressure: Systolic >180, < or = to 100mm/hg Diastolic >100 PRE/During/Post Tx Pulse: >100 or < 60 -slow / fast / irregular Temperature: >100F or < 96 F Review of hemodialysis flow sheets in the facility conference room on 11/12/24 revealed an example of the following discrepancies: Patient # 4 Flow Sheet Dated: 9/03/24. Initiation of treatment: 06:18 AM Termination of treatment: 09:31 AM. Pre-Vitals: 186/71 heart rate 63. Post Vitals: 187/63 heart rate 44. The Following vitals were recorded: 06:18 AM: Blood Pressure: 203/77 with heart rate 60. There was no documentation found that the direct patient care staff notified the registered nurse of the severe hypertension. 06:30 AM: Blood Pressure: 211/74 with heart rate 60: There was no documentation found that the direct patient care staff notified the registered nurse of the severe hypertension. 06:49 AM: Clonidine 0.1mg provided by the registered nurse. 06:52 AM: The registered nurse completed the patient’s Pre-Dialysis Assessment. Pre-Vital blood pressure was out of acceptable range per the facility reportable events. There was no documentation found that the registered nurse was notified or addressed the hypertension prior to the initiation of treatment. The first documentation that the blood pressure was addressed was 31 minutes after treatment initiated and blood pressure had increased to 211/74. Patient # 16 Flow Sheet Dated: 11/11/24. Initiation of treatment: 10:18 AM Termination of treatment: 2:26 AM. Pre-Vitals: 132/90 heart rate 76. Post Vitals: 140/70 heart rate 79. The Following vitals were recorded: 12:30 PM: Blood Pressure: 178/104 with heart rate 69. The PCT documented the following “UF on, resting comfortably, access visible, RN notified, Patient alert. 1:30 PM: Blood Pressure: 91/60 with heart rate 69: The PCT documented the following “Resting comfortably, access visible, RN notified, UF off ...denies complains .... UF off as per the RN. 3:26 PM: (one hour after treatment ended) the registered nurse documented the following “patient leaving 0.6 kg above dry weight. Unable to achieve EDW per tolerance. Patient advised to limit fluid intake and to seek medical attention for any SOB / discomforts. MD made aware, VSS, Escorted to scale. No documentation was found that the registered nurse addressed the elevated diastolic and or the hypotension at time of event. Patient # 17 Flow Sheet Dated: 06/17/24. Pre dialysis nursing evaluation completed at 08:41 AM revealed the following documentation: Fluid Assessment: Ankle: 2+ 2-4mm indent disappears in 10-15 seconds Post Assessment nursing evaluation completed at 13:35 PM No documentation found post dialysis that the registered nurse addressed the pre dialysis edema. An interview conducted with (Staff #1) on 11/14/24 following her own review of the findings revealed she was unaware of the discrepancies found in the flow sheets. Staff #2 confirmed the above findings.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 50181 Based on personnel file review and staff interview the facility failed to ensure skills checklists and written competency tests were completed on employees to determine their competency necessary to perform their job duties prior to performing the assigned duties. Findings were: Staff #1 (Clinic Manager) Annual Clinical Exam completion date: 10/05/2023 Annual Clinical Skills Validation completion date: 10/03/2023 Annual Water Skills Checklist completion date: 09/12/2023 CPR Expiration: 07/31/2024 An interview with staff #1 on 11/13/2024 confirmed the above findings indicating her annual skills validations were expired. Staff #1 was on leave from June 25, 2024, to October 14, 2024. During the interview she verbalized she knew her skills were past due after being on leave and had not updated them since being back from leave. Staff #3 (Charge Nurse) Annual Water Skills Checklist completion date: 9/21/2023 An annual water skills checklist was completed during the time of the survey (11/12/2024) In review of the facility’s water logs it was noted that Staff #3 completed water checks during the period of 09/22/2024-11/11/2024 without a current water skills checklist. The above findings were verified and confirmed by Staff #1 during an interview on 11/13/2024. Staff #7 (RN) Hire date: 04/04/2024 Experienced RN with dialysis experience; however, per the Clinic Manager (Staff #1) her dialysis experience was greater than one year old requiring her to complete the 280 hours of training. Initial training was completed on 06/01/2024; Staff #7 will not meet the minimum 6 months of dialysis for charge capability until 12/01/2024. During an interview with Staff #1 and Staff #2 on 11/13/2024 the date of charge capability was confirmed to be 12/01/2024. During an interview, Staff #1 reported staff #7 worked in the charge nurse capacity on 10/19/2024 due to a call in. Staff #1 reported she was in the facility during this time; however, in review of Staff #1’s personnel file it was determined her clinical exam, clinical skills and annual water checklists were not current. Staff #18 (CCHT) Annual Water Skills Checklist completion date: 9/06/2023 An annual water skills checklist was completed during the time of the survey (11/13/2024) In review of the facility’s water logs it was noted that Staff #18 completed water checks during the period of 09/07/2024-11/12/2024 without a current water skills checklist. The above findings were verified and confirmed by Staff #1 during an interview on 11/13/2024.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 50181 Based on document review and interview 1 of 13 direct patient care staff did not have evidence of CPR (cardiopulmonary resuscitation). Staff #1 CPR card on file expired 7/31/2024. During an interview with staff #1 on 11/13/2024 she confirmed her CPR had expired while she was out of leave and had not been renewed as of 11/13/2024. Staff #1 reported she was on leave from June 25, 2024, to October 14th, 2024. Staff #1 is the Clinic Manager and Supervising Nurse for the facility.”

“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: 50181 Based on interview and record review, the Registered Nurse (RN) failed to conduct the initial nursing assessment on the date of admission prior to the treatment start time. Review of the facility’s current policy and procedure titled, “Nursing Supervision and Delegation (version 6, published date 11/06/2023)” directs nursing staff as follows: “The following tasks that may NOT be delegated: *Assessment of the patient prior to treatment initiation for patients new to dialysis and receiving their first ever outpatient dialysis treatment ...” Findings: Patient #1 was admitted to the facility on 09/12/2024 Initial RN Assessment completed at 11:46 AM Treatment start time: 11:43 AM Patient #2 was admitted to the facility on 10/24/2024 Initial RN Assessment completed at 12:00 PM Treatment start time: 11:46 AM Patient #3 was admitted to the facility on 09/10/2024 Initial RN Assessment completed at 11:37 AM Treatment start time: 11:30 AM Patient #5 was admitted to the facility on 08/07/2024 Initial RN Assessment completed at 05:32 PM Treatment start time: 1:56 PM Patient #5 was readmitted to the facility on 06/03/2024 Initial RN Assessment completed at 2:06 PM Treatment start time: 1:59 PM An interview with staff #1 on 11/13/2024 the above findings were confirmed and acknowledged.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 50181 Based on medical record review, policy review and staff interview the facility failed to ensure the direct patient care (DPC) staff reported patient status changes during treatment to the Registered Nurse (RN) to ensure a reassessment was performed and documented with appropriate interventions and/or physician notification, if required. Findings included: A review of facility policy titled, “Patient Assessment and Monitoring,” version 4 with a published date of 05/01/2023 includes the following guidance: “Purpose: The purpose of this policy is to provide guidance to Fresenius Kidney Care (FKC) direct patient care staff (DPC) on assessment and monitoring patients before, during and after treatment. Data Collection: Direct patient care staff may collect data such as weight, blood pressure (BP), 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 (RN) must assess the patient. *The registered nurse will notify the patient’s physician/physician extender of any abnormal findings, if necessary, based on clinical judgment for additional instructions. *The registered nurse will assess/re-assess any findings addressed pre or during treatment as needed. During Treatment: *Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulation. Step 1: Blood Pressure Record blood pressure *Recheck blood pressures after a drop that requires interventions such as administering normal saline. *Reposition electronic cuff or use manual cuff for aberrant blood pressure readings. Report to the nurse: *systolic blood pressures greater than 180 mm/Hg *diastolic blood pressures greater than 100 mm/Hg *blood pressure less than or equal to 100 mm/Hg systolic Pulse Record pulse. Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute. *Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular ...” Patient #1 treatment record dated 03/18/2024 reveals the following: 06:36: Blood Pressure 98/56 There is no documentation acknowledging the systolic BP was a reportable finding and was reported to the RN by the DPC staff. 09:51: Blood Pressure 93/54 There is no documentation acknowledging the systolic BP was a reportable finding and was reported to the RN by the DPC staff. 10:05 Blood Pressure 103/58 Pulse 101 There is no documentation acknowledging the pulse was a reportable finding and was reported to the RN by the DPC staff. Patient #1 treatment record dated 03/15/2024 reveals the following: 10:32 Blood Pressure 94/57 There is no documentation acknowledging the systolic BP was a reportable finding and was reported to the RN by the DPC staff. On 04/09/2024, an interview with the Clinic Manager confirmed the facility’s reportable parameters and documentation required for out of parameter findings pre/intra/post dialysis treatment by the DPC staff to the registered nurse.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 50181 Based on record review and staff interview the Medical Director (MD) failed to ensure that all policies and procedures relative to patient infection control and safety are adhered to by all individuals who treat patients in the facility. The facility failed to adhere to the facility policy and procedure titled, “Device Evaluation Following Patient Event,” with a published date of 04/05/2021, version 3. The above referenced policy and procedure includes the following guidance: “Purpose: To define the process for the documentation and evaluation of devices in use at the time of a patient event. Policy: *The facility technical staff and clinical staff will complete a “Device Evaluation Following Patient Event Form” when equipment is being utilized for the dialysis treatment and following the patient event. The “Device Evaluation Following Patient Event Form” should be completed as soon as practical following the patient event. *Trained staff will collect dialysate specimens and send to Spectra Laboratories for both colony count and LAL analysis as soon as practical following a patient event and in accordance with “Microbiology Monitoring of Dialysate” policy. (Not applicable for all types of equipment)” Findings include: During the on-site investigation on 04/09/2024, a review of the Device Evaluation Following Patient Event form completed for this event which occurred on 03/18/2024 reveals there is no documentation that dialysate specimens were collected and sent to the laboratory for colony count and LAL analysis by a trained facility staff after the event and the sequestering of the machine. On 04/09/2024, the above findings were confirmed during interviews with the Clinic Manager (Personnel #1) Facility Bio-Medical Technician (Personnel #2) and Area Technical Operations Manager (Personnel #3).”

“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: 50181 Based on observation and interview, the facility staff failed to maintain all equipment, citing five of five hemodialysis machines with degradation of the outer coating of paint not allowing for effective cleaning and disinfection of the machines between patients. These findings have the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by increasing the potential of cross-contamination between patients. Findings included: On 03/11/2024 at approximately 0930, the surveyor and clinical manager (Personnel #1) conducted a tour of the treatment floor observing five out of five hemodialysis machines with damage to the outer coating of paint on the machines not allowing for effective cleaning and disinfection of the machines between uses. On 03/11/24 at 0945, the Clinic Manager (Personnel #1) stated the majority of the machines had this type of damage and were in the process of being repainted. During an interview with the facility biomedical technician (Personnel #2) on 3/11/24 at 1000, he confirmed the appropriate supplies have been obtained to complete the repairs and were expected to be completed within the next two weeks.”

“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: 50181 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for blood flow rate (BFR) in patient #2 and patient #3 medical records review. The facility staff failed to verify the ordered prescription matched the prescription the patient was receiving before treatment initiation. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders which could negatively impact the effectiveness and adequacy of the dialysis treatment for in-center hemodialysis patients receiving care at this facility. Findings include: Patient #2: A review of the treatment sheet dated 03/08/2024 revealed the following: “Hemodialysis Orders: Blood Flow Rate (BFR): 400” Tx initiation line at 10:01 includes the following: “BFR:400” Tx line at 10:31 includes the following: “BFR: 375” Comments recorded for 10:31: “UF on; Resting Comfortably; Access visible; Green AMP light; Denies complaints; Patient Alert” There was no documentation indicating the need to adjust the BFR, no notification of the nurse by the technician and no follow-up note from the nurse addressing the change in hemodialysis prescription orders by the physician. Patient #3: A review of the treatment sheet dated 08/08/2023 revealed the following: “Hemodialysis Orders: Blood Flow Rate (BFR): 350” Staff # 4 documented a BFR of “250 ml/min” throughout the patient’s entire treatment. There was no documentation indicating the need to adjust the BFR, no notification of the nurse by the technician and no follow-up notes from the nurse addressing the change in hemodialysis prescription orders by the physician. An interview with Staff # 1 on 03/11/2024 confirmed that she had identified treatment sheet records during her reviews that indicated the dialysis prescription orders were not being followed as ordered per the physician. She reported she provides re-education to the staff as needed related to appropriate treatment sheet documentation.”