Fmcna - Shawnee

“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: 34689 Based on observation, record review, and interview, the facility failed to ensure that emergency equipment was readily available to manage medical and non-medical emergencies that are likely to threaten the health and safety of patients and staff, citing three of four emergency eyewash stations (Eyewash stations #1 in center hemodialysis treatment area, #2 and #3 emergency eywash stations in the home therapy program unit). Findings: A review of the facility’s Health, Safety and Risk Management Policy dated 08/15/2021, read in part, “...American National Standard for Emergency Eyewash and Shower Equipment...Each eyewash location...be identified with a highly visible sign...Maintenance and training...eyewash units shall be inspected and maintained in accordance with manufactureres’ instructions...plumbed equipment shall be activated weekly to verify proper operation...” On 05/22/2025 at 10:12 AM, the surveyor and Personnel #1 observed Personnel #15 f flushed the emergency eyewash station on top of the sink across dialysis station #10 in the in center hemodialysis treatment area. The eyewash station head was dirty covered with whitish crusted sediments. On 05/22/2025 at 10:15 AM, Personnel #1 stated the emergency eyewash head was dirty and needed to be cleaned. On 05/27/2025 at 10:20 AM, the surveyor and Personnel #9 observed 2 emergency eyewash stations in the home therapy program unit, 1 emergency eyewash station located in room #1 and 1 emergency eyewash station in room #4. A review of the facility’s Emergency Eyewash Weekly preventative maintenance log dated 01/27/2025 and 05/12/2025, read in part, “...Number of eyewash stations...reading 2...” The Emergency Eyewash Weekly preventative maintenance log showed no documented evidence the 2 emergency eyewash stations located in the home therapy program unit were checked and maintained. On 05/27/2025 at 10:25 AM, Personnel #9 stated: 1. the 2 emergency eyewash stations located in the home therapy program unit were not checked nor had preventative maintenance and 2. We did not know those eyewash stations were there.”

“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: 34689 Based on observation, record review, and interview, the facility failed to ensure one of one facility area (hemodialysis treatment area) provided and monitored a sanitary environment to minimize the transmission of infectious agents within and between the units or other public areas. Findings: A review of the facility’s General Cleanliness and Infection Control Guidelines Policy dated 05/05/2025, read in part, “...Policy...all areas must be kept clean...facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection...specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling...facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff...” On 05/21/2025 between 2:00 PM - 2:05 PM, the surveyor observed 3 gray carts in the treatment area across dialysis stations #4, #10, and #23. The gray carts were dirty and wet, covered with whitish crusted sediment and had blue pads on top of the wet top level of the cart. On 05/21/2025 at 2:06 PM, Personnel #1 stated the staff need to clean and dry the gray carts.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to monitor and implement biohazard and infection control policies and activities within the dialysis unit, citing two of two personnel (Personnel #17 and #20 This practice placed all patients and staff at risk for accidental needlesticks and cross - contamination and/or infection. Findings: A review of the facility’s General Cleanliness and Infection Control Guidelines Policy dated 05/05/2025, read in part, “...Policy...all areas must be kept clean...facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection...specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling...facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff...” 1. On 05/21/2025 at 2:08 AM, the surveyor observed Personnel #20 placed 2-3 gauze soaked with red blood on Patient #17’s chairside table where he rested his arm while he waited for bleeding to stop. On 05/21/2025 at 2:10 AM, Personnel #1 stated the biohazard container should be brought closer to discard the blood soaked gauze. 2. On 05/27/2025 at 10:20 AM, the surveyor observed Personnel #17 discontinued Patient #14’s dialysis treatment via right CVC. Personnel #17 placed the used 10 milliliters (ml) syringes X2 with blood on the hub of the syringes on top of the chairside table mixed with clean blue and red catheter port caps. Personnel #17 used the red and blue caps and connected the caps on the venous and arterial catheter ports. On 05/27/2025 at 10:28 AM, Personnel #1 stated and informed Personnel #17 that clean and dirty supplies cannot be mixed and to discard syringes with blood on the hub on the sharps container.”

“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: 34689 Based on record review, and interview, the facility failed to evaluate the care received based on the dialysis prescription, citing one of one dialysis patient (Patients #2 and #4) who did not have physician’s orders for the provision of care. Findings: A review of the facility’s Physician Order Documentation Policy dated 07/03/2023, read in part, “...Background...all medications, laboratory tests and treatments a paitent receives require an electronic order signed by the physician, nurse practitioner...it is the nurses’ responsibility to ensure that ll treatments, medication...or any care provided to the patient have an accurately documented physician order...” 1. Patient #2: On 05/21/2025 at 12:30 PM, the surveyor conducted an interview with Paitent #2. When asked what training was being completed, they stated home hemodialysis (HHD). Patient #2 stated they did in center hemodialysis (ICHD) and recently aslo did Peritoneal Dialysis (PD). When Paitent #2 was asked the reason they were now in training for home hemodialysis (HHD), they stated it was due toproblems with their PD not draining. A review of Patient #2’s clinical record showed Peritoneal Dialysis (PD) catheter placed on 03/06/2025 and the first continous ambulatory peritoneal dialysis (CAPD) training started on 03/19/2025. A review of Patient #2’s Home Trainibg Vitals or Staff Assist Time note dated 03/19/2025, read in part, “...Patient (Pt) completed 3 exchanges today...Personnel #4...” A review of Order Details dated 03/19/2025, showed, “...Peritoneal Dialysis...CAPD training with exchange 5X week for 15 times...Personnel #4...” There was no documented evidence for an order to perform a first flush of the Patient #2’s PD catheter and if the PD catheter was first flushed prior to the exchange or training to check and assess for PD catheter function. There was no documented evidence for an order of what solution to use to flush the PD catheter and the amount of the flush. On 05/27/2025 at 11:42 AM, when Personnel #14 was asked if the PD catheter needed to be flushed first prior to starting the exchanges and training, Personnel #14 stated, yes and that they went ahead to ask Personnel #2 and they also stated that they have to flush first. Personnel #14 stated that they was unable to find an order for the first time flush and type and amount of solution to flush Patient #4’s PD catheter. 2. Patient #4: On 05/21/2025 at 11:00 AM, when Personnel #1 was asked if they have patients dialyzing in their isolation room due to positive Hepatitis B, she stated, yes, Patient #4. A review of Patient #4’s clinical record showed Patient #4 have positive Hepatitis B. A review of the Orders Summary Report dated 03/01/2024 - 05/21/2025 showed no documented evidence of orders from Personnel #6 to put Patient #4 in the isolation room and for facility staff to maintain isolation precautions. - Imported Provider Note Comp Results Report dated 05/19/2025, read in part, “...Hepatitis B found at the time of start of dialysis August 2016, followed by Hepatology...started on Tenofovir weekly in February 2017...Personnel #6...” On 05/22/2025 at 12:05 PM, Personnel #1 stated: 1. they saw no orders for isolation and/or isolations precautions. 2. they saw no documentation on the treatment sheets and POC that facility staff used and maintained isolation precautions during the provision of dialysis care to Patient #4.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 34689 Based on record review and interview, the IDT failed to develop and implement completely written, individualized POCs for one of one patient (Patient #4). Findings included: A review of the facility’s Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+) dated 11/06/2023, read in part, “...Purpose...the purpose of this policy is to prevent transmission of Hepatietis B...Policy...In addition to dialysis precautions, all patients with hepatitis B infection...treated in the dialysis facility require additional infection control precautions as outlined in this policy...” Patient #4: A review of Patient #4’s clinical records showed Patient #4 was admitted in the facility on 05/23/2026, and the following: - The Plan of Care (POC) dated 12/25/2024, showed no documented evidence Patient #4’s positive Hepatitis B condition status. - Treatment sheets dated 01/13/2025 - 01/17/2025 and 05/12/2025/ - 05/16/2025/ showed no documented evidence isolation precautions were maintained and used by facility staff during Patient #4’s provision of dialysis care. - Imported Provider Note Comp Results Report dated 05/19/2025, read in part, “...Hepatitis B found at the time of start of dialysis August 2016, followed by Hepatology...started on Tenofovir weekly in February 2017...Personnel #6...” On 05/22/2025 at 12:05 PM, Personnel #1 stated: 1. They saw no orders for isolation and/or isolations precautions. 2. They saw no documentation on the treatment sheets and POC that facility staff used and maintained isolation precautions during the provision of dialysis care to Patient #4.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure that adverse events were continuously monitored in the facility’s QAPI program, citing two of two patients (Patients #2 and #3) Findings: A review of the facility’s Patient Safety Reporting Event and Documentation Policy dated 02/06/2023, read in part, “...Policy...when a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event...staff are responsible for timely completion of these policy requirements...Categories, Event Description...category: Access...Modality HD/HHD...event description...hemodialysis access infiltration...definitions...perforation of vessel wall...modality...PD...event description...peritoneal catheter malfunction...definitions...inability to either drain or infuse or both...” 1. Patient #2: A review of Patient #2’s treatment sheet dated 03/17/2025, read in part, “...11:56 AM... treatment initiated without problem...Personnel #18...12:06 PM...Patient (Pt) infiltrated, blood returned, treatment (Tx) ended...Personnel #19...nursing evaluation 2:45 PM...late entry...venous needle infiltrated. Tx ended...Personnel #19...” A review of the adverse event log for the year 2025 did not include Patient #2’s infiltration on 03/17/2025. On 05/27/2025 at 11:15 AM, Personnel #1 stated she did not find an adverse event reported for Patient #2’s infiltration on 03/17/2025 and stated that per policy if the dialysis treatment is interrupted, that should be reported. 2. Patient #3: A review of Patient #’s Clinical Notes Report dated 03/24/2025, read in part, “...Approximately 800 milliliters (ml) fluid instilled. Pt disconnected from stay safe set to allow to dwell...Pt stood to walk around while dwelling...after standing and walking for a few minutes Pt reported sudden rectal, right lower quadrant (RLQ) and scrotal pain. Scrotal edema remained...Personnel #2...” A review of the adverse event log for the year 2025 did not include Patient #3’s pain and scrotal edema while dwelling on 03/24/2025. On 05/22/2025 at 12:17 PM, Personnel #5 stated they saw no adverse event reported for Patient #3’s pain and scrotal edema on 03/24/2025.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 34696 Based on record review, interview, and policy review, the facility failed to provide emergency training to one of one patient (Patient #1) according to the facility policy. Findings included: A review of the “Guidelines for Emergency Preparedness” policy published 07/23/202 included, “Quarterly, all...patients must receive fire drill and emergency evaluation training. Training must be documented in QAI (Quality Assessment and Improvement) and on the fire drill attendance form...Patient education...Facility staff must educate patients on...Evacuation procedures...Emergency Disconnection procedures...Emergency Meal Plan...Facility Contact Information...Shelter Information...Transportation Information...Emergency Preparedness.” A review of Patient #1’s Medical Records did not include documented evidence of the third quarter fire drill. On 01/23/2024 at 2:45 PM, the Clinical Manager (Personnel #1) said there was no evidence of Patient #1’s third quarter emergency training.”

“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: 34696 Based on observations, record review, and interview, the facility failed to ensure one of six staff (Personnel #4) performed hand hygiene while performing patient care. Findings included: A review of the “Hand Hygiene” policy published 11/06/2023 included, “Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water...when...before and after direct contact with patients...before performing any invasive procedure...immediately after removing gloves...after contact with inanimate objects near the patient.” On 01/23/2024 at 11:25 AM, RN (Registered Nurse, Personnel #3) was observed initiating treatment at hemodialysis station #22. The RN removed her gloves and did not sanitize or wash her hands. The RN went back to the chair side to assess the patient. The RN did not sanitize or wash her hands. The RN retrieved a pair of gloves from a box of gloves. The RN proceeded to enter information into the dialysis machine. The RN removed her gloves. While holding the contaminated gloves in her left hand, she used the right hand to pump hand sanitizer into her right hand. At 11:40 AM, the RN said she was supposed to sanitize her hands after removing her gloves and touching equipment.”

“BICARB JUGS RINSED DAILY/STORED DRY CFR(s): 494.40(a) 6.5 Concentrate distribution: bicarb jugs rinsed daily/stored dry Bicarbonate concentrate jugs should be rinsed with treated water and stored inverted at the end of each treatment day. Pick-up tubes should also be rinsed with treated water and allowed to air dry at the end of each treatment day. This Standard is not met as evidenced by: 34696 Based on observation, record review, and interview, the facility failed to store 10 of 10 bicarbonate concentrate jugs in an inverted position. Findings included: A review of the “Bicarbonate Concentrate Container, Cap, and Wand Disinfection Procedure” policy published 01/02/2024 included, “Fill jug with RO (reverse osmosis) or DI (deionized) water and bleach...place the cap on the jug and tighten...invert/shake the jug...empty the bleach solution from the jug...fill the jug with RO or DI water and swirl while dumping the rinse water...invert concentrate container to drain and allow to air dry...store capped concentrate container in a clean and dry storage location.” On 01/23/2024 at 10:50 AM, 10 concentrate jugs were observed on a utility cart and on the floor in the water treatment area. The jugs were not clean and stored inverted. At the time of the findings, the ATOM (Area Technical Manager, Personnel #2) said the jugs should have been cleaned and stored inverted.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 34696 Based on observation, record review, and interview, the IDT (Interdisciplinary Team) failed to ensue one of six patient’s (Patient #1) vascular access was evaluated by an RN (Registered Nurse) after an infiltration. Findings included: A review of the “Needle Infiltration” policy published 09/07/2021 included, “Definition...A puncture through the vessel wall leading to leaking of blood into the surrounding tissues...Signs and symptoms of infiltration include...immediate sharp pain...swelling...hematoma...The following steps should be followed to treat a needle infiltration that occurs while on hemodialysis...Notify the nurse in charge of an infiltration...Apply ice to the site of the infiltration...Instruct patient to apply ice to the infiltrate for the first 24 hours and then warm compresses for the following 24 hours...Instruct the patient to watch for...complications and contact the physician should any occur...Document event in the patient’s treatment record.” On 01/23/2024 at 11:45 AM, in an interview, it was observed that the circumference of Patient #1’s left upper arm was red and bruised. Patient #1 said his vascular access had been infiltrated the week prior. Patient #1’s hemodialysis treatment record dated 01/18/2024 indicated, “access infiltrated.” There was no documented evidence the RN in charge was notified for assessment and/or intervention. There was no documented evidence the physician was notified. On 01/24/2024 at 10:35 AM, the Clinical Manager (Personnel #1) said there was no documented evidence that Patient #1’s infiltrated vascular access was reported to the RN for assessment. There was no docuented evidence of interventions and education to Patient #1 regarding the infiltration There was no documented evidence the physician was notified.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 34696 Based on observation, record review, and interview, the facility failed to safeguard records against unauthorized use and keep confidential all information contained in patients’ records in one of one area (home therapies storage room #2). Findings included: On 01/22/2024 at 10:40 AM, 10 storagge boxes were observed in the home therapies storage room #2. The boxes had patients’ rmedical records inside them. It was further observed that the door to the room did not have a locking mechanism to secure patients’ personnel information. At the time of the findings, the Home Therapies Clinical Manager (Personnel #10) said they were not awae how long the records had been in the room. Personnel #2 said the records should be stored in a secured location.”