Ara - Lawton Dialysis East

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 34689 Based on observation, interview, and record review, the facility failed to ensure that infection control practices and techniques were followed and maintained to prevent risk to patient health and safety, as evidenced by: Findings included: 1. The facility failed to ensure that two of two facility areas (treatment area and medication area) provided and monitored a sanitary environment to minimize the transmission of infectious agents within and between the units or other public areas. Cross refer to V tag: V 111. 2. The facility failed to ensure two of two personnel (Personnel #2 and #5), performed handwashing or used handsanitizer between change of gloves during the provision of patient care and/or when going from a “dirty” area or task to a “clean” area or task. This practice placed all patients at risk for cross-contamination and/or infection. Cross refer to V tag: V 113. 3. The facility failed to ensure that staff followed correct infection control procedures, citing five of five facility staff (Personnel #1, #2, #3, #4, and #5) failed to use Personal Protective Equipment (PPE) during the provision of patient care in the dialysis treatment area. Cross refer to V tag: V 115. 4. The facility failed to ensure that staff clearly designated areas, citing one of one facility area (in-center treatment area) for the storage of clean unused supplies and used equipment, in that “clean” unused supplies were stored on dirty storage containers or areas. This practice had the potential for harm to all patients and personnel in the facility with possible cross contamination of clean and contaminated supplies and/or equipment. Cross refer to V tag: V 117. 5. The facility failed to monitor and implement biohazard and infection control policies and activities within the dialysis unit, citing one of one personnel (Personnel #5) in that the facility personnel held used dialyzer and bloodlines, walked passed dialysis stations with patients, and placed used syringes with blood on the chairside table prior to discarding. This practice placed all patients and staff at risk for accidental needlesticks and cross - contamination and/or infection. Cross refer to V tag: V 121. 6. The facility failed to ensure all staff had infection control training, citing three of six staff (Personnel #8, #9, and #10). Cross refer to V tag: V 132. 7. The facility failed ensure expired medications were discarded in accordance with the manufacturer’s directions in one of two areas (Medication area). Cross refer to V tag: V 143.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 34689 Based on record review and interview, facility failed to ensure facility’s staff were trained in operation and/or testing for quality control testing of the facility’s pH/conductivity meter and failed to assess staffs’ ability to detect color, in that personnel files did not include color blindness testing and/or results. This practice had the potential risk of inaccurate detection of pH/conductivity of the dialysate used to provide hemodialysis treatment. This practice potentially threatened the health and safety of all patients who received hemodialysis treatment in the facility, as evidenced by: Findings included: 1. The facility failed to ensure that personnel checking and/or testing for the facility’s water system operations, function, and/or chlorine/chloramines testing had a color blindness test done, citing seven of seven personnel (Personnel #3, #5, #7, #10, #11, and #15) in that personnel files did not include a color blindness test. Cross refer to V tag: V 196. 2. The facility staff did not follow the manufacturer’s instructions regarding testing the dialysate conductivity and approximate pH with an independent method to use solutions that has not reached a predetermined expiry date for quality control testing prior to each dialysis treatment day. Cross refer to V tag: V 250.”

“CFC-PERSONNEL QUALIFICATIONS CFR(s): 494.140 This Condition is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure that all staff practiced within their scope of practice, and demonstrated the competencies and/or skills necessary to serve collectively the comprehensive needs of the patients, as evidenced by: Findings included: 1. The Based on observation, record review, and interview, the facility failed to ensure that the staff demonstrated the competencies necessary to serve collectively the comprehensive needs of the patients, citing four of six staff (Personnel #3, #10, #14, and #15) who did not have documented evidence of competencies and/or skills checklists to demonstrate that they had the skill required to perform dialysis. Cross refer to V tag: V 681. 2. The facility failed to have a charge nurse that was in the facility who was out of orientation and 3 months experience in providing nursing care to patients on maintenance dialysis., citing one of one Registered Nurse (Personnel #1) who had not completed orientation and training in hemodialysis. Cross refer to V tag: V 686.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 34689 Based on record review and interview, the medical director failed to ensure that all policies and procedures relative to patient care, infection control, and safety were adhered to by all individuals who treat patient in the facility, as evidenced by: Findings included: Medical Director failed to participate in the development, review, and approval of facility policies that affect patient care and safety, citing six of six facility policies and procedures (Infection Control, starting a treatment with an arterio venous (AV) fistula, bleaching or disinfection of dialysis machines, quality control testing of pH/conductivity meter, and fire/disaster drill policy and Emergency Preparedness). This deficient practice had the potential to affect all patients who received treatment at this facility. Cross refer to V tag: V 714.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 34689 Based on observations, record review, and interview, the Governing Body failed to demonstrate respoonsibility for the opereraation of the facility, health care, and safety of the patients, staff, and public. Findings included: 1. The governing body failed to appoint an individual to exercise responsibility for the management of the facility and the provision of all dialysis services. Cross refer to V tag: V 752. 2. The governing body failed to ensure that five of five staff (Personnel #3, #8, #9, #10, and #14) were oriented to the facility. Cross refer to V tag: V 760.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to develop, review, and update the emergency preparedness plan annually. This deficient practice affected 25 of 25 patients, who currently dialyzed in this facility, as listed on the patient list given by the medical director on 04/02/25. Findings included: On 04/02/25 at 10:00 AM, the surveyor conducted an interview with the medical director (Personnel #6) and when asked if the facility is currently under American Renal Management, he stated no that since 2023 this facility was independently owned. A review of the facility’s Disaster Preparedness Manual included, “...American Renal Management...Emergency Preparedness Plan (EPP) Review Log...effective date 08/01/17...annual review date 01/28/2022...presented in Governing Body date 01/28/2022...presented in TQM date 02/28/2022...” There was no documented evidence the facility’s disaster preparedness manual and emergency preparedness plan was developed, updated since 2022 and approved by the current governing body of the facility. On 04/03/25 at 3:40 PM, the medical director (Personnel #6) and clinical manager (Personnel #7) confirmed the above findings.”

“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, checked, and maintained to manage medical and non-medical emergencies that are likely to threaten the health and safety of patients, citing one of one emergency supplies and medications (Emergency Evacuation Box). Findings included: A review of the facility’s Employee Related Policies Emergency Box, included, “...An emergency box needs to be maintained in the facility to house supplies and medications that would be needed to treat patients should they have to be evacuated from the facility in an emergency situation...the contents of the box need to be listed and checked monthly for expiration dates...the month and signature of the person doing the checks needs to be recorded on the form...” On 04/02/45 at 11:25 AM, the surveyor and the clinical manager (Personnel #7) opened the facility’s evacuation/emergency box container. - The emergency evacuation box did not include a binder and showed no documented evidence of current patients list and information, current facility staff and/or doctor information to be accessed in case of emergency or disaster. - A review of the emergency box supplies log included, “...the emergency box needs to be checked monthly to rotate stock and to check expiration dates on medications...03/01/2024 and 10/02/24...” and showed no documented evidence the emergency box supplies were checked in 2025. - A review of the facility’s Hemodialysis Emergency Evacuation Box Lock Tracking log, included, “...Year 2024...March 03/01/2024...September...10/2/24...” On 04/02/25 at 11:30 AM, the clinical manager (Personnel #7) confirmed the above findings.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure facility personnel citing six of six personnel (Personnel #5, #8, #9, #10, #14, and #15) demonstrated training on Emergency Preparedness as no documented evidence in their personnel file. Findings included: A review of the facility’s Staff Orientation/Inservice Policy included, “...3. Initial Inservices...During the first week of orientation to the facility, the new employees must receive an inservice on infection control...disaster policies and procedures...4. Continuing Education/Inservices...competency tests and skills check lists will be kept in personnel files...Mandatory...Fire Extinguisher/Disaster...” A review of personnel files showed no documented evidence of emergency preparedness education/training for the following staff: 1. Licensed Practical Nurse (LPN) Personnel #5. 2. Registered Dietitian (RD) Personnel #8. 3. Social Worker (SW) Personnel #9. 4. Patient Care Technician (PCT) Personnel #10. 5. Registered Nurse (RN) Personnel #14. 6. Biomed Personnel #15. On 04/03/25 at 3:30 PM, the clinical manager (Personnel #7) confirmed the above findings.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure staff and patients participate in the quarterly fire drill/disaster, citing two of two years (2024 and 2025). This placed all patients, staff, and visitor at risk for harm during different types of disasters that could occur such as fire and natural disasters. Findings included: A review of the facility’s Employee Related Policies included, “...c. Disaster Policy All patients are inserviced on what to do if a disaster occurs and how to evacuate the facility. This is done when the patient is admitted to the facility and on a quarterly basis thereafter...On a quarterly basis, all staff will participate in fire/disaster drills that will be conducted on each patient and staff shift. The staff that participates will write their names on the drill sheet and names of the patients who are on dialysis at the time...” 1. On 04/02/25 at 10:42 AM, the surveyor conducted an interview with Patient #2. When asked if they participated in the facility’s fire drill exercises, they stated no fire drills and that they cannot remember. On 04/02/25 at 10:52 AM, when Patient #1 was asked how long had he come to this facility for dialysis treatments, he stated 4 - 5 years. When asked if and when he participated in the facility’s fire drill exercises, he stated it’s been awhile. On 04/02/25 at 11:24 AM, when Patient #3 was asked how long had they come to this facility for dialysis treatments, They stated 9 months. When asked if and when they participated in the facility’s fire drill exercises, they stated no fire drills. On 04/02/25 at 11:30 AM, the surveyor requested for the facility’s fire drills done in the facility for patients and staff for 2024 and 2025. The clinical manager (Personnel #7) stated that they were not able to find any fire drills done and will have to wait for Personnel #11, a patient care technician (PCT) and the administrative assistant. On 04/03/25 at 3:30 PM, the clinical manager (Personnel #7) when asked about the requested fire drills done in the facility, stated that there were no fired drills found and that Personnel #11 was unable to find them. Personnel #7 confirmed the above findings.”

“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 that two of two facility areas (treatment area and medication area) provided and monitored a sanitary environment to minimize the transmission of infectious agents within and between the units or other public areas. Findings included: A review of the facility’s Infection Control Policy dated 03/31/2009 (American Renal Associates), included, “...standard Precautions...all employees are required to follow standard precautions...facility rules are to be followed...good hand washing techniques with antimicrobial soap...use of clean, hand washing and dirty sinks...use of clean versus dirty areas...machines and surrounding areas are to be cleaned with 1:100 bleach solution between patients...” On 04/02/25 between 11:10 AM - 11:50 AM, during a tour of the facility, the surveyor and clinic manager (Personnel #7) observed the following: 1. Treatment area: The cabinets under 4 sinks in the treatment area were dirty with dried yellowish brownish stains with scattered grayish blackish sediments. The cabinet under the designated “dirty sink” sink #2 located towards the laboratory area, had a strong foul odor while closed and once opened the foul odor became stronger. There was a reddish brownish drip stain approximately 20 - 24 inches in length on the cabinet that faced dialysis stations #14, #15, and #16. On 04/02/25 at 11:15 AM, clinical manager (Personnel #7) confirmed the above findings. When asked what the odor was, she stated she does not know. 2. Medication area: The medication refrigerator was dirty with brownish sediments and cluttered with with plastic blue cap, piece of foil, and paper literature of medicine. On 04/02/25 at 11:17 AM, clinical manager (Personnel #7) confirmed the above findings.”

“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: 34689 Based on observation, record review, and interview, the facility failed to ensure two of two personnel (Personnel #2 and #5), performed handwashing or used handsanitizer between change of gloves during the provision of patient care and/or when going from a “dirty” area or task to a “clean” area or task. This practice placed all patients at risk for cross-contamination and/or infection. Findings included: A review of the facility’s Infection Control Policy dated 03/31/2009 (American Renal Associates), included, “...standard Precautions...all employees are required to follow standard precautions...facility rules are to be followed...good hand washing techniques with antimicrobial soap...use of clean, hand washing and dirty sinks...use of clean versus dirty areas...machines and surrounding areas are to be cleaned with 1:100 bleach solution between patients...” 1. On 04/02/25 at 10:40 AM, the surveyor observed the patient care technician (PCT) (Personnel #2) removed gloves and don on gloves three times without the use of handsanitizer or washed her hands while she worked with Patient #6 at dialysis station #23. On 04/02/25 at 10:42 AM, personnel #2 confirmed the above findings. 2. On 04/02/25 at 10:50 AM, the surveyor observed the licensed practical nurse (LPN) (Personnel #5) removed gloves and reapplied gloves, removed Patient #1’s arterio venous fistula (AVF) needle and did not use handsanitizer. On 04/02/25 at 10:51 AM, personnel #5 confirmed the above findings.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to ensure that staff followed correct infection control procedures, citing five of five facility staff (Personnel #1, #2, #3, #4, and #5) failed to use Personal Protective Equipment (PPE) during the provision of patient care in the dialysis treatment area. Findings included: A review of the facility’s Infection Control Policy dated 03/31/2009 (American Renal Associates), included, “...standard Precautions...all employees are required to follow standard precautions...facility rules are to be followed...barrier gowns should be worn in the treatment area when performing tasks...” On 04/02/25 at 9:30 AM, the surveyor observed Registered Nurse (Personnel #1), Patient Care Technicians (Personnel #2, #3, and #4), and the Licensed Practical Nurse (Personnel #5) were in the treatment area during turnover, assisting patients did not have protective gown on. On 04/02/25 at 9:35 AM, personnel #1 confirmed the above findings.”

“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: 34689 Based on observation, record review, and interview, the facility failed to ensure that staff clearly designated areas, citing one of one facility area (in-center treatment area) for the storage of clean unused supplies and used equipment, in that “clean” unused supplies were stored on dirty storage containers or areas. This practice had the potential for harm to all patients and personnel in the facility with possible cross contamination of clean and contaminated supplies and/or equipment. Findings included: A review of the facility’s Infection Control Policy dated 03/31/2009 (American Renal Associates), included, “...standard Precautions...all employees are required to follow standard precautions...facility rules are to be followed...good hand washing techniques with antimicrobial soap...use of clean, hand washing and dirty sinks...use of clean versus dirty areas...machines and surrounding areas are to be cleaned with 1:100 bleach solution between patients...” On 04/02/25 at 11:00 AM, the surveyor and clinic manager (Personnel #7) observed an Intravenous (IV) pump with a red dried stain unlabeled whether clean or dirty and stored beside 3 Oxygen concentrator machines in the treatment area. On 04/02/25 at 11:05 AM, confirmed the above findings. When asked if the IV pump was clean or dirty and if the Oxygen concentrator machines were clean or dirty, she stated that they are supposed to be clean.”

“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 one of one personnel (Personnel #5) in that the facility personnel held used dialyzer and bloodlines, walked passed dialysis stations with patients, and placed used syringes with blood on the chairside table prior to discarding. This practice placed all patients and staff at risk for accidental needlesticks and cross - contamination and/or infection. Findings included: A review of the facility’s Infection Control Policy dated 03/31/2009 (American Renal Associates), included, “...standard Precautions...all employees are required to follow standard precautions...facility rules are to be followed...good hand washing techniques with antimicrobial soap...Proper handling of lab spcimens, trash...use of clean, hand washing and dirty sinks...use of clean versus dirty areas...machines and surrounding areas are to be cleaned with 1:100 bleach solution between patients...” 1. On 04/02/25 at 10:30 AM, the surveyor and clinic manager (Personnel #7) observed the Licensed Practical Nurse (LPN) (Personnel #5) removed the used dialyzer and bloodlines from the dialysis machine at dialysis station #22, walked passed dialysis stations #19, #20, and #21 during patients’ dialysis treatments, across the nursing station to discard the used dialyzer and bloodlines with blood. On 04/02/25 at 10:31 AM, the clinic manager (Personnel #7) confirmed the above findings. 2. On 04/02/25 at 11:36 AM, the surveyor observed the LPN (Personnel #5) flushed patient #8 left central venous catheter ports with 10 milliliters (ml) of Normal Saline syringe each port, removed the 10 ml syringes and placed the 10 ml syringes with blood on the tip of the syringes on top of the chairside table. On 04/02/25 at 11:37 AM, personnel #5 confirmed the above findings.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure all staff had infection control training, citing three of six staff (Personnel #8, #9, and #10). Findings included: On 04/03/25 at 2:45 PM, a review of the facility’s staff personnel files did not include documented evidence of infection control training and education for the following: 1 Registered Dietitian (Personnel #8). 1 Social Worker (Personnel #9). 1 Patient Care Technician (Personnel #10). On 04/03/25 at 3:30 PM, the clinical manager (Personnel #7) confirmed the above findings.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 34689 Based on observation and interview, the facility failed to ensure expired medications were discarded in accordance with the manufacturer’s directions in one of two areas (Medication area). Findings included: 1. On 04/02/25 at 11:17 AM, the surveyor and clinical manager observed the medication refrigerator included 2 expired Intradialytic Parental Nutrition (IDPN) for Patient #5 2:1 sol 427 milliliter (ml) “discard after 03/28/25” and for Patient #11 2:1 sol 440 ml. “discard after 03/28/25.” 2. At 11:18 AM, there were 4 250 ml Intravenous (IV) bags 0.9% Normal Saline expiration date Dec 22 stored in the medication room drawer, available for use. On 04/02/25 at 11:20 AM, clinical manager (Personnel #7) confirmed the above findings.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure that personnel checking and/or testing for the facility’s water system operations, function, and/or chlorine/chloramines testing had a color blindness test done, citing seven of seven personnel (Personnel #3, #5, #7, #10, #11, and #15) in that personnel files did not include a color blindness test. Findings included: A review of the facility’s Staff Orientation/Inservice Policy (no date), included, “VIII. Staff Orientation. Facility Orientation...an orientation program will be maintained at the facility and will be overseen by the governing body...all staff must be oriented to the facilities policies...specific to their area of care...new employees will also be oriented to the facility...Note: prior to an offer of employment being made, clinical and technical staff must pass a color blindness test...this is required due to the results of tests performed in the facility...” A review of facility staff who checked the facility’s water testing showed personnel files showed no documented evidence and not include color blindness, for the following staff: 1. Registered Nurses (RN): Personnel #7 and #14, charge nurses of the facility. 2. Licensed Practical Nurse (LPN): Personnel #5. 3. Patient Care Technician (PCT): Personnel #3, #10, and #11 checks daily water and dialysate testing. 4. Biomed: Personnel #15. On 04/03/25 at 3:30 PM, clinical manager confirmed the above findings.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 34689 Based on interview and record review, the facility staff did not follow the manufacturer’s instructions regarding testing the dialysate conductivity and approximate pH with an independent method to use solutions that has not reached a predetermined expiry date for quality control testing prior to each dialysis treatment day. Findings included: On 04/02/25 at 11:15 AM, the surveyor and the clinic manager (Personnle #7) observed the solutions for quality control testing for the pH/conductivity of the dialysate prior to patients treatments used by the facility staff were labeled with expiration date of 12/17/24 for the solutions of CalRite 7.00 pH QC standard solutions, standard buffeed solution, CalRite QC 14.0 ms/cm conductivity solution, Probe site sensor cleaning solution, CalRite 10.00 pH QC standard solution, and CalRite 4.00 pH QC standard solution. On 04/02/25 at 11:17 AM, clinic manager (Personnel #7) confirmed the above findings. When asked if these were the solutions used by facility staff, she stated that’s used for the Myron L for checking the conductivity.”

“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: 34689 Based on record review and interview, the IDT (Interdisciplinary Team) failed to ensure that each patient’s fluid management and/or status was assessed and/or addressed, citing two of two patients (patient #4 and #11) in that patient Blood Pressures were not evaluated and/or adjusted, the management of which may require reassessment of medication needs, adjustment in target weight, and changes to the Plan of Care. Findings included: 1. Patient #4: A review of Patient #4’s clinical records showed dialysis order report dated 03/23/25 included dry weight of 78.0 kilogram (kg). A review of Hemodialysis (HD) Treatment Flowsheet dated 03/28/25 included, “...pre dialysis weights of 86.3 kg...treatment started at 5:53 AM...treatment ended 6:23 AM...Notes...patient meds unable to be given due to (d/t) water issue and having to stop treatments early...Personnel #14...post dialysis weight 88.0 kg...” Patient #4’s pre dialysis weight 86.3 kg was 8.3 kg over the ordered dry weight. There was no documented evidence Patient #4’s weight was rechecked and no documented evidence facility staff called the physician (Personnel #6) to notify of 8.3 kg over dry weight. A review of HD Treatment Flowsheet dated 03/31/25 included, “...pre dialysis weight 88.0 kg...post dialysis weight 85.5 kg...” Patient #4’s pre dialysis weight 88.0 kg was 10 kg over the ordered dry weight and post dialysis weight was 85.5 kg, 7.5 kg over dry weight. There was no documented evidence Patient #4’s physician (Personnel #6) was notified of 10.0 kg over dry weight and 7.5 kg over dry weight post dialysis for orders and/or clarification of orders regarding fluid removal. On 04/03/25 at 10:30 AM, the physician (Personnel #6) confirmed the above findings. 2. Patient #11: A review of Patient #11’s HD Treatment Flowsheet showed elevated blood pressures during dialysis treatments and showed no documented evidence Patient #11’s physician (Personnel #6) was notified of elevated blood pressures for orders and/or clarification of orders regarding blood pressure treatment and management. HD Treatment flowsheet dated 01/03/25 included, “...7:00 AM Blood Pressure (BP) 183/115...7:30 AM BP 180/122...” HD Treatment flowsheet dated 01/08/25 included, “...11:01 AM BP 160/136...11:52 AM BP 163/147...11:56 AM BP 154/111...” HD Treatment flowsheet dated 01/22/25 included, “...7:08 AM BP 152/112...7:38 AM BP 173/110...8:08 AM BP 150/123...8:39 AM BP 187/102...” On 04/03/25 at 3:25 PM, the clinical manager confirmed the above findings.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 34689 Based on record review and interview, the IDT (Interdisciplinary Team) failed to ensure that the POC (Plan of Care) included vascular access monitoring, citing one of one patient (Patient #3) whose hemodialysis treatment sheets did not include documentation of assessments and evaluation of a newly placed vascular access. Findings included: Patient #3: On 04/02/25 at 11:25 AM, the surveyor conducted an interview with Patient #3 at dialysis station #18. Patient #3’s right central venous catheter (CVC) was used for dialysis treatment and the surveyor observed Personnel #7 discontinued the dialysis treatment. When Patient #3 was asked about a permanent access for her dialysis treatment, she stated that she has a new access on her left upper arm and pointed to her upper left arm. A review of Patient #3’s clinical record included, “...access list...type: arterio venous fistula (AV fistula)...site left upper arm...placement date 02/06/2025...” A review of Patient #3’s Hemodialysis (HD) treatment flowsheets dated 03/17/25 - 03/31/25 showed no documented evidence facility staff assessed Patient #3’s left upper arm AV fistula for bruit and thrill, site assessment, and function. On 04/02/25 at 2:30 PM, the clinical manager (Personnel #7) 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: 34689 Based on observation, record review, and interview, the facility failed to ensure that the staff demonstrated the competencies necessary to serve collectively the comprehensive needs of the patients, citing four of six staff (Personnel #3, #10, #14, and #15) who did not have documented evidence of competencies and/or skills checklists to demonstrate that they had the skill required to perform dialysis. Findings included: A review of the facility’s Staff Orientation/Inservice Policy (no date), included, “VIII. Staff Orientation. Facility Orientation...an orientation program will be maintained at the facility and will be overseen by the governing body...all staff must be oriented to the facilities policies...specific to their area of care...new employees will also be oriented to the facility...Clinical Staff Orientation...1. Previous dialysis experience...must be oriented to the policies and procedures of this facility prior to performing any clinical duties. After a comprehensive orientation, completion of mandatory inservices and demonstration of competency in performing dialysis procedures, the trainee will complete a skills check list and take a competency exam...examination must be passed...2. No dialysis experience...A certificate of completion of the training program will be signed...a copy of this ceritificate is to be retained in the employee’s personnel file...Mandatory inservices (annually)...infection control/bloodborne pathogens (an aknowledgment is required)...Nurse/Technical training...Competency testing...compliance program...” On 04/03/25 at 2:45 PM, a review of the facility staff’s personnel files did not include documented evidence of hemodialysis knowledge examination/testing and competency and skills, and/or water/dialysate competency and skillls for the following staff: 1 Registered Nurse (RN): Personnel #14. 2 Patient Care Technicians (PCT): Personnel #3, and Personnel #10. 1 Biomed Personnel #15. On 04/03/25 at 3:30 PM, the clinical manager (Personnel #7) confirmed the above findings.”

“PQ-CHARGE NURSE-12 MO NURSING+3 MO DIALYSIS CFR(s): 494.140(b)(3)(i)-(ii) The charge nurse responsible for each shift must- (i) Be a registered nurse, a licensed practical nurse, or vocational nurse who meets the practice requirements in the State in which he or she is employed; (ii) Have at least 12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis; This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to have a charge nurse that was in the facility who was out of orientation and 3 months experience in providing nursing care to patients on maintenance dialysis., citing one of one Registered Nurse (Personnel #1) who had not completed orientation and training in hemodialysis. Findings included: A review of the facility’s Staff Orientation/Inservice Policy (no date), included, “VIII. Staff Orientation. Facility Orientation...an orientation program will be maintained at the facility and will be overseen by the governing body...Clinical Staff Orientation...2. No dialysis experience...all employees who are hired no dialysis experience will complete a formal training program...will consist of day to day training (both classroom and practical) for a period of 2 months...All “hands-on” procedures will only be done under the supervision of either the inservice instructor or a preceptor who will insure that procedures are completed safely...” On 04/02/25 at 9:40 AM, the surveyor conducted an interview with the Registered Nurse (RN) (Personnel #1). When asked who the charge nurse was, she stated it was her. When asked when she started working in this clinic, she stated that this is her first day out on the floor and started orientation yesterday. Personnel #1 stated the trained 6 months and 3 weeks at another dialysis facility and did not finish her training. Personnel #1 stated that clinic manager (Personnel #7) just left and was in the facility this morning. On 04/02/25 at 9:45 AM, personnel #1 confirmed the above findings. On 04/02/25 at 9:50 AM, the patient care technician (PCT) (Personnel #2) was asked if there was another RN this morning in the facility, she stated that Personnel #7 was here at 5:00 AM and waited for Personnel #1 to arrive and left around 8:00 AM. Personnel #2 stated that a licensed practical nurse (LPN) (Personnel #5) is here at the facility. A review of Personnel #1’s Employment Application included employment dates from 01/24 - 04/25 as an RN hospice case manager. On 04/03/25 at 9:00 AM to 4:00 PM, the surveyor had requested for Personnel #1’s resume and personnel file and the clinical manager (Personnel #7) stated that Personnel #1 has the file with her and stated that she was still on orientation. On 04/03/25 at 4:10 PM, the clinical manager (Personnel #7) confirmed the above findings.”

“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: 34689 Based on record review and interview, the Medical Director failed to participate in the development, review, and approval of facility policies that affect patient care and safety, citing six of six facility policies and procedures (Infection Control, starting a treatment with an arterio venous (AV) fistula, bleaching or disinfection of dialysis machines, quality control testing of pH/conductivity meter, and fire/disaster drill policy and Emergency Preparedness). This deficient practice had the potential to affect all patients who received treatment at this facility. Findings included: On 04/02/25 at 10:00 AM, the surveyor conducted an interview with the Medical Director (Personnel #6) and when asked if the facility is currently under American Renal Management, he stated no that since 2023 this facility was independently owned. On 04/02/25 and 04/03/25, the surveyor requested policies and procedures for Infection Control, starting a treatment with an arterio venous (AV) fistula, bleaching or disinfection of dialysis machines, quality control testing of pH/conductivity meter, and fire/disaster drill policy and Emergency Preparedness. A review of the policies and procedures given to the surveyor such as Infection Control (03/31/2009), Treatment Initiation - AV Fistula, AV Graft (last revised 08/04/16), CVC evaluation and dressing change (last revised 02/17/12), and disaster policy, included with “American Renal Associates” in the policy. The Residual Bleach Testing of the Dialysis Machine Procedure included, “...American Renal Associates...last revised 02/21/17...” The policy and procedure book manual included, “...Important Information: The contents of this manual are the property of the Lawton Dialysis Center...Affiliate of American Renal Associates...” “The Governing Body Approval...the Governing Body of Lawton Dialysis Center has reviewed and approved the contents of this manual...this manual will remain in effect for the period of one year...Additional revisions or changes...will be noted on each page...approved...January 28, 2022 and will remain in effect until January 31, 2023...” A review of the facility’s Governing Body showed no documented evidence of updated and current approval of the facility’s policy and procedures. The facility’s policy and procedures for starting a treatment with an arterio venous (AV) fistula, bleaching or disinfection of dialysis machines, and fire/disaster drill policy showed no documented evidence of current and updated information as to who developed the policy and procedure (P&P) and who approved the P&P. On 04/03/2025 at 3:40 PM, the medical director (Personnel #6) confirmed the above findings.”

“GOV-APPOINT CEO/ADMINISTRATOR CFR(s): 494.180(a) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, This Standard is not met as evidenced by: 34689 Based on staff interview and facility record review, the governing body failed to appoint an individual to exercise responsibility for the management of the facility and the provision of all dialysis services. Findings included: On 04/02/25 at 11:10 AM, the surveyor conducted an interview with Personnel #7. When asked what position does she have for this facility, she stated nurse manager. Personnel #7 stated that she started here since October 2024 and has been coming in this facility consistently for 3 months.Personnel #7 stated that she is fulltime in another facility. A review of the facility’s governing body on 04/03/25 at 3:35 PM showed no documented evidence of governing body meeting minutes in 2024 and 2025 and no documented evidence of an appointment or any staff as administrator or nurse manager or Personnel #7’s appointment as designated nurse manager or administrator of the facility responsible for the provision of all dialysis services. On 04/03/25 at 3:40 PM, the medical director (Personnel #6) and the clinic manager (Personnel #7) confirmed the above findings.”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 34689 Based on record review and interview, the governing body failed to ensure that five of five staff (Personnel #3, #8, #9, #10, and #14) were oriented to the facility. Findings included: A review of the facility’s Staff Orientation/Inservice Policy (no date), included, “VIII. Staff Orientation. Facility Orientation...an orientation program will be maintained at the facility and will be overseen by the governing body...all staff must be oriented to the facilities policies...specific to their area of care...new employees will also be oriented to the facility...Note: prior to an offer of employment being made, clinical and technical staff must pass a color blindness test...this is required due to the results of tests performed in the facility...” A review of personnel files for Personnel #3 date of hire (DOH) 02/20/24, Personnel #8 DOH 01/01/23, Personnel #9 DOH 01/31/23, Personnel #10 DOH 01/01/23, and Personnel #14 DOH 03/01/23, showed no documented evidence of orientation to the facility. On 04/03/2025 at 3:30 PM, the clinical manager (Personnel #7) confirmed the above findings.”