Fmcna - North Harvard

“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 and interview, the facility failed to provide one of ten patients (Patient #3) emergency preparedness orientation and training. Findings: A review of the “Guidelines for Emergency Preparedness” policy dated 07/03/2023 read in part, “Patient education...Facility staff must educate patients on...Evacuation procedures...emergency disconnection.” ~ Patient #3: A review of the facility’s “Admission and Discharge” listing dated 02/28/2025 to 05/28/2025 showed Patient #3 was admitted to the facility on 04/17/2025 and “New to ESRD (End Stage Renal Disease).” The medical record did not show documented evidence that Patient #3 had emergency preparedness education. On 05/29/2025 at 1:30 PM, the Director of Operations stated 1. Patient #3 did not receive emergency preparedness education and 2. the education should have been conducted at admission.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 34696 Based on observation and interview, the facility failed to maintain the building free from defects and/or hazards in two of two areas (Acid Prep area and the adjacent Storage area). Findings: A review of the “General Cleanliness and Infection Control Guidelines” policy published 05/05/2025 showed, “All areas must be kept clean and organized, including but not limited to the treatment area , water supply room”...”Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff”...”Such cleaning should be done regularly using a schedule developed by the facility”...”A written schedule of cleaning procedures shall be established, reviewed, documented annually in Governing Body and implemented which sets forth the cleaning and method of decontamination considering the types of surfaces, soils, and tasks and procedures being performed per policy.” On 05/28/2025 at 9:25 am, during a tour of the facility, the surveyor observed the floor throughout the acid prep area and the adjacent storage area had not been maintained. The floor was dirty and gritty. On 05/28/2025 at 9:30 AM, the Clinical Manager said the areas were supposed to be maintained by the staff.”

“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: 34696 Based on observation and interview, the facility failed to conduct preventive maintenance in one of one area (acid prep area). Findings included: On 05/28/2025 at 9:25 AM, it was observed that the acid tanks in Acid Prep area had not been maintained. The tanks had dried acid splattered around the bases of the tanks. On 05/28/2025 at 9:30 AM, the Clinical Manager said the equipment was supposed to be maintained by the staff.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 34696 Based on record review and interview, the IDT failed to ensure that each patient received the necessary care and services to manage their volume status and BP in one of three patients (Patient #1). Findings: A review of the “Patient Assessment and Monitoring” policy dated 05/01/2023 showed, “During treatment”...”Obtain BP and pulse every 30 minutes or more as needed but not to exceed 45 minutes...Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes” ...” “Record BP...” “Follow the steps...for monitoring patient and machine parameters during treament”...”Report to the nurse”...s”ystolic greater than 180 mmHg (millimeters of mercury)...Diastolic BP greater than 100 mmHg...Document any findings and interventions in the medical record.” ~ Patient #1: The hemodialysis treatment record dated 04/18/2025 showed Patient #1’s vital signs were not obtained every 30 to 45 minutes. The time between Patient #1’s vital signs ranged from 53 to 63 minutes. The hemodialysis treatment record dated 04/23/2025 did not show the intradialytic delivered dialysis prescription (blood flow rate, dialysis flow rate, arterial pressure, venous pressure, ultrafiltration rate, fluid given, access checks and Kecn (conductivity clearance). The hemodialysis treatment record dated 04/25/2025 showed Patient #1 had high BPs during the treatment. The BPs were 176/108, 257/158, and 154/119. There was an hour between the BPs. There was no documented evidence the RN (Registered Nurse) was notified to assess Patient #1. On 05/30/2025 at 9:30 AM, the Clinical Manager said the LPN should have notified the RN when Patient #1’s BPs were high. On 5/30/2025 at 9:40 AM, the Director of Operations there was a problem with the communication from the dialysis machine to the electronic medical record. Personnel #1 said they had not had an opportunity to audit patient records for completeness and accuracy.”

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to ensure emergency preparedness program was monitored and updated to meet the health and safety of all patients and staff of the facility during an emergency event, as evidenced by: Findings included: 1. The facility failed to ensure that emergency equipment and supplies were readily available for use and checked for expiration dates to manage medical and non-medical emergencies that are likely to threaten the health and safety of patients, citing one of one facility’s emergency log (Evacuation Crate Log) and citing 28 of 28 1 liter Normal Saline bags. This practice placed all patients treating in this dialysis facility for potential harm for using an expired IV solutions in management of medical and non-medical emergencies. Cross refer to E tag: E0028. 2. The facility failed to ensure all staff have an Emergency Preparedness training, citing one of one facility staff (Personnel #11) in that personnel file showed no documented evidence of an Emergency Preparedness training. This practice placed all patients and staff’s safety at risk during an emergency in the facility. Cross refer to E tag: E0036”

“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 one of one direct patient care staff (Personnel #2) wear gloves when going inside the isolation room and touching equipment. Cross refer to V tag: V 113. 2. The facility failed to ensure that staff followed correct infection control procedures, citing one of one facility staff (Personnel #15) failed to use Personal Protective Equipment (PPE) while cleaning the dialysis machines. Cross refer to V tag: V 115. 3. The facility failed to ensure that staff clearly designated areas, citing one of one facility area (nursing station) 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. 4. The facility failed to ensure used dialyzer and bloodlines in the isolation room were discarded in a regular gray garbage can and not labeled red bagged isolation, citing one of one facility staff (Personnel #2) in that used dialyzer and bloodlines were discarded in a gray garbage can inside the isolation room. Cross refer to V tag: V 130. 5. The facility failed to ensure that biohazard and infection control practices were monitored and implemented, citing one of one personnel (Personnel #5) in that, facility staff did not follow infection control practices and/or activities within the unit. This practice placed all patients and staff in the facility at risk for potential harm for infection and/or cross contamination. Cross refer to V tag: V 142.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 34689 Based on observation and interview the facility failed to ensure proper maintenance of the physical environment which could impact the safety and health of the patients and staff, as evidenced by: Findings included: 1. The the facility failed to ensure that three of three patients (Patients #5, #12, and #13) were provided a safe environment to be able to call for assistance or help when needed during their dialysis treatment in the isolation rooms. Cross refer to V tag: V 401. 2. The facility failed to implement and maintain a program to ensure that all equipment was maintained citing 15 of 15 hemodialysis machines (Machine serial number for Items #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, and #15). Cross refer to V tag: V 403.”

“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: 1. The facility failed to ensure emergency preparedness program was monitored and updated to meet the health and safety of all patients and staff of the facility during an emergency event. Cross refer to E tag: E0003. 2. The facility failed to ensure that infection control practices and techniques were followed and maintained to prevent risk to patient health and safety. Cross refer to V tag: V 110. 3. The facility failed to ensure staff were appropriately trained and/or have an updated skills that are sustained, three of three Charge Nurses (Personnel #1, #4, and #8) in that, personnel files showed incomplete competency skills. These findings have the potential to cause harm to all patients at the facility by the failure to train and evaluate the staff on their knowledge and understanding of the facility water treatment system skills and/or machine equipment procedures and skills. Cross refer to V tag: V 260. 4. The facility failed to ensure proper maintenance of the physical environment which could impact the safety and health of the patients and staff. Cross refer to V tag: V 400.”

“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 and supplies were readily available for use and checked for expiration dates to manage medical and non-medical emergencies that are likely to threaten the health and safety of patients, citing one of one facility’s emergency log (Evacuation Crate Log) and citing 28 of 28 expired 1 liter Normal Saline IV bags. This practice placed all patients treating in this dialysis facility for potential harm for using an expired IV solutions in management of medical and non-medical emergencies. Findings included: On 05/16/2024 at 4:25 PM, the surveyor and the Regional Vice President (RVP) (Personnel #3) observed the following: 1. A review of the facility’s Emergency Evacuation Box Contents Log sheet for 2024 showed the supplies and expiration of the contents of the Emergency Evacuation Box were last checked on January 2024. The Emergency Evacuation Box and its contents were not checked for February, March, April, and May 2024. 2. The facility’s Evacuation Crate container included 28 IV bags of 1 liter Normal Saline (NS) with an expiration date of January 2024. On 05/16/2024 at 4:45 PM, the Regional Vice President (RVP) (Personnel #3) confirmed the above findings. A review of the facility’s Emergency Medications, Equipment and Supplies Policy dated 05/01/2023, included, “...Emergency Evacuation Box...an emergency evacuation box must...be checked monthly or after use for contents, expiration dates and cleanliness...An itemized log must be kept indication the contents and expiration dates of contents. Items approaching expiration must be recorded and replaced prior to the actual expiration date...””

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure all staff have an Emergency Preparedness training, citing one of one facility staff (Personnel #11) in that personnel file showed no documented evidence of an Emergency Preparedness training. This practice placed all patients and staff’s safety at risk during an emergency in the facility. Findings included: A review of the Patient Care Technician (PCT) Personnel #11’s personnel file showed no documented evidence for Emergency Preparedness training. On 05/17/2024 at 2:30 PM, Personnel #14 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 and interview, the facility failed to ensure one of one direct patient care staff (Personnel #2) wear gloves when going inside the isolation room and touching equipment. Findings included: On 05/16/2023 at 10:17 AM, the surveyor inquired from the facility administrator (Personnel #2) if there is a call light that the patient in the isolation room can use when inside the isolation room and if the isolation room door needed to be closed. Personnel #2 stated that there is call light inside the isolation room and went inside the isolation room and without donning on gloves reached out to a red colored cord that hung on the wall beside the foot of the dialysis recliner, and handed the red cord to Patient #5. On 05/16/2024 at 10:19 AM, personnel #2 confirmed the above findings. When asked if she needed to use gloves when entering the isolation room and touching the call light cord and giving the cord to the patient, she stated that she did not touch the patient and that she used the hand sanitizer inside the room. On 05/16/2024 at 12:10 PM, when the Regional Vice President (RVP) (Personnel #3) was asked what the policy was when entering the isolation room, if gloves were needed to be worn, she stated, yes that she checked the policy. A review of the facility’s Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg) dated 11/06/2023, included, “...Purpose: The purpose of this policy is to prevent transmission of Hepatitis B...Policy...In addition to dialysis precautions, all patients with hepatitis B infection...treated in the dialysis facility require additional infection control precautions...All disposable items, including the patient’s dialyzer, shall be considered infectious, and shall be red-bagged, labeled as Infectious Waste...” A review of the facility’s Personal Protective Equipment (PPE) Policy dated 11/06/2023, included, “...Gloves...staff must remove gloves and wash hands after...patient care...touching any surfaces within the patient station...””

“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 one of one facility staff (Personnel #15) failed to use Personal Protective Equipment (PPE) while cleaning the dialysis machines. Findings included: On 05/16/2024 at 4:00 PM, the surveyor observed facility staff (Personnel #15) cleaned and set up dialysis machines at dialysis stations #3 and #4 without a gown on. On 05/16/2024 at 4:15 PM, Personnel #3 confirmed the above findings. When asked if personnel #15 needed to wear a gown while she cleaned and set up dialysis machines, she stated, yes. A review of the facility’s Exposure Categories and Determination Policy dated11/06/2023, included, “Category A - job classifications that involve exposure or reasonably anticipated exposure to blood or other potentially infectious material or that involve likelihood for spills or splashes of blood or other potentially infectious material...Tasks and Procedures with exposure determination...Task: Cleaning the machine and patient area...category A...Gloves X...Gown X...””

“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 (nursing station) 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: On 05/16/2024 at 9:50 AM, the surveyor observed the nursing station by dialysis stations #3 and #19 had a counter top that was dirty with sticky grayish residues and whitish paper tapes, taped on the counter. There were two used face shields that were stored on top of the nursing station counter. On 05/16/2024 at 9:52 AM, Personnel #2 confirmed the above findings. A review of the facility’s General Cleanliness and Infection Control Guidelines Policy dated 02/07/2022, included, “All areas must be kept clean...””

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 34689 Based on observation, interview, and record review, the facility failed to ensure used dialyzer and bloodlines in the isolation room were discarded in a regular gray garbage can and not labeled red bagged isolation, citing one of one facility staff (Personnel #2) in that used dialyzer and bloodlines were discarded in a gray garbage can inside the isolation room. Findings included: On 05/16/2024 at 10:40 AM, the surveyor observed the Registered Nurse (Personnel #1) removed the used dialyzer with the used bloodlines from the dialysis machine used in the isolation room for Patient #5. Personnel #1 discarded the used dialyzer with the used bloodlines from the dialysis machine used in the isolation room for Patient #5 in the gray garbage can by the dialysis machine beside the dialysis recliner in the isolation room across dialysis stations #4 and #5. On 05/16/2024 at 10:42 AM, personnel #1 confirmed the above findings. When personnel #1 was asked if that’s the facility policy to use gray garbage can for used dialyzer and bloodlines used by a HBsAG positive patient, he stated, we put in this gray garbage then bring it out and put them in the red biohazard trash can. A review of the facility’s Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg) dated 11/06/2023, included, “...Purpose: The purpose of this policy is to prevent transmission of Hepatitis B...Policy...In addition to dialysis precautions, all patients with hepatitis B infection...treated in the dialysis facility require additional infection control precautions...All disposable items, including the patient’s dialyzer, shall be considered infectious, and shall be red-bagged, labeled as Infectious Waste...””

“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: 34689 Based on observation, record review, and interview, the facility failed to ensure that biohazard and infection control practices were monitored and implemented, citing one of one personnel (Personnel #5) in that, facility staff did not follow infection control practices and/or activities within the unit. This practice placed all patients and staff in the facility at risk for potential harm for infection and/or cross contamination. Findings included: On 05/16/2024 at 10:05 AM - the surveyor observed the Patient Care Technician (PCT) (Personnel #5) removed the arteriovenous fistula (AVF) needle from Patient #3’s AVF site. Personnel #5 pulled the AVF needle out without applying the safety, while she held the AVF site with her left fingers, she held the AVF needle with her right hand and with the sharp point of the needle pointed up, applied the safety device. On 05/16/2024 at 10:10 AM, personnel #5 confirmed the above findings. A review of the facility’s General Cleanliness and Infection Control Guidelines Policy dated 02/07/2022, included, “Contaminated needless/sharps...during use, sharps containers shall be...easily accessible and located as close as is feasible to the immediate area where sharps are used...contaminated sharps shall be discarded immediately...other regulated waste...regulated waste shall be placed in a container that is accordance with...bloodborne standard...is closeable, leak proof...closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport...” A review of the facility’s Post Treatment Fistula Needle Removal Procedure dated 07/06/21, read in part, “...Background...Incorrect needle removal technique can result in difficulty achieving hemostasis, potential injury to the access and increase the risk of contaminated needlestick to patients and staff...procedure...6. carefully remove...engage safe needle device per manufacturer’s directions...discard the needle in sharps container...””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to ensure staff were appropriately trained and/or have an updated skills that are sustained, three of three Charge Nurses (Personnel #1, #4, and #8) in that, personnel files showed incomplete competency skills. These findings have the potential to cause harm to all patients at the facility by the failure to train and evaluate the staff on their knowledge and understanding of the facility water treatment system skills and/or machine equipment procedures and skills. Findings included: 1. On 05/16/2024 at 11:09 AM, the surveyor and the Area Technical Operations Manager (ATOM) (Personnel #12) observed the Registered Nurse (RN) (Personnel #4) checked the water system’s total chlorine. When personnel #4 was asked which tank did the water sample she tested came from, personnel #4 stated that she does not know. When asked what happens to the cold water from the city gets in the water system, personnel #4 was unable to verbalize regarding the water system’s blending valve and other water system flow and function. When personnel #4 was asked how long had she been working in this facility and if she does charge, she stated that she used to be a travel nurse and have been here for about 8 months. She stated that she’s a charge nurse. On 05/16/2024 at 11:15 AM, the ATOM confirmed the above findings. A review of Personnel #4’s personnel file showed no documented evidence of water knowledge testing and an incomplete Direct Patient Care Skills (DPC) Validation dated 09/26/2023. 2. A review of the facility’s charge nurses personnel files showed incomplete DPC skills validation for the Registered Nurses (RN) (Personnel #1 and #8) dated 02/27/2024 for Personnel #1 and dated 09/25/2023 for Personnel #8. On 05/17/2024 at 2:25 PM, Personnel #14 confirmed the above findings. A review of the facility’s Knowledge, Skills and Competency Evaluation for Clinical Staff Policy dated 10/12/2021, included, “...Policy: Employees are required to pass all exams, including an initial and annual exam. Employees are required to successfully complete all skills requirements...skills validation...Employees without current documented competency within the past 365 days may be removed from performing independent direct patient care (DPC) until competency is demonstrated and documented...””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to ensure that three of three patients (Patients #5, #12, and #13) were provided a safe environment to be able to call for assistance or help when needed during their dialysis treatment in the isolation rooms. Findings included: 1. On 05/16/2024 at 10:15 AM, the surveyor observed Patient #5 dialyzed in the isolation room across dialysis stations #4 and #5. When Patient #5 was asked when and if he needed help or assistance while he dialyzed, how does he call the nurses, he stated that he guess he would have to call loudly. There was no visible call light that patient can access to call. The isolation room door is propped open. On 05/16/2023 at 10:17 AM, the surveyor inquired from the facility administrator (Personnel #2) if there is a call light that the patient in the isolation room can use when inside the isolation room and if the isolation room door needed to be closed. Personnel #2 stated that there is call light inside the isolation toom and went inside the isolation room and without donning on gloves reached out to a red colored cord that hung on the wall beside the foot of the dialysis recliner, and handed the red cord to Patient #5. On 05/16/2024 at 10:19 AM, personnel #2 confirmed the above findings. 2. On 05/17/2024 at 8:40 AM, the surveyor observed two patients (Patients #12 and #13) dialyzing in the isolation rooms #25 and #26. There were no visible call light cords for Patients #12 and #13 to call for assistance or help. When Patient #12 was asked how to call for help when she needed to, she stated, I don’t know how. When Patient #13 was asked how to call for help when she needed to, she stated, I don’t know how. The surveyor called Personnel #9 and when asked where the call light cords were for Patients #12 and #13, she stated, the cords were by the wall. When asked if Patients #12 and #13 can reach those cords if they needed to call for help, she stated, no. On 05/17/2023 at 8:50 AM, personnel #9 confirmed the above findings. A review of the facility’s Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg) dated 11/06/2023, included, “...Purpose: The purpose of this policy is to prevent transmission of Hepatitis B...Policy...In addition to dialysis precautions, all patients with hepatitis B infection...treated in the dialysis facility require additional infection control precautions...” A review of the faciity’s Personal Protective Equipment (PPE) Policy dated 11/06/2023, included, “...Gloves...staff must remove gloves and wash hands after...patient care...touching any surfaces within the patient station...””

“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: 34689 Based on observation and interview, the facility failed to implement and maintain a program to ensure that all equipment was maintained citing 15 of 15 hemodialysis machines (Machine serial number for Items #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, and #15). Findings included: A review of the facility’s dialysis machines disinfection log showed 15 dialysis machines were not disinfected with bleach weekly or every 7 days in the month of April 2024, as follows: Machine serial #: Disinfection Dates for April 2024: 1. 3TOS-121600 9, 17 2. 4TOS-129739 9, 17 3. 8TOS-227269 9, 17 4. 5TOS-139070 9, 17 5. 5TOS-139145 9, 17 6. 3TOS-121626 10, 18 7. 6TOS-167298 10, 18 8. 4TOS-129904 10, 18 9. 6TOS-167337 10, 18 10. 6TOS-167465 10, 18 11. 7TOS-207095 10, 18 12. 8TOS-225706 10, 18 13. 7TOS-207103 10, 18 14. 8TOS-227927 17, 25 15. 8TOS-227875 17, 25 On 05/17/2024 at 10:25 AM, the Area Technical Operations Manager (ATOM) (Personnel #12) confirmed the above findings. A review of the facility’s Hemodialysis: Acid Clean, Chemical Rinse, and Heat Disinfection Policy dated 05/02/2022, included, “...Manufacturer’s instructions must be followed. The following defines the minimum dialysis machine cleaning and disinfection requirements. The frequency and duration of system cleaning and disinfection will be scheduled to maintain microbial contamination to conform with the company policy and procedures...Chemical rinse must be performed at a minimum weekly (every 7 days)...The chemical rinse program will be performed using bleach...” A review of the manufacturer’s Instruction for Use (IFU) 2008T Machine Operator’s Manual P/N 490122 Rev AA Chapter 5 Disinfection and Maintenance, Table 34-Cleaning and Disinfection Recommended Frequency, included, “...Procedure...Chemical/Rinse...Frequency: Weekly...””

“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 observation, record review and interview, the facility failed to evaluate the appropriateness of the dialysis prescription, citing two of two dialysis patients (Patients #5 and #9) who did not have physician’s orders for the provision of care. Findings included: 1. Patient #5: On 05/16/2024 at 10:15 AM, the surveyor observed Patient #5 dialyzing in the isolation room. The surveyor conducted an interview with Patient #5 and when asked if he knew the reason why he dialyzed in the isolation room, he stated, yes. A review of Patient #5’s clinical records showed admission to the facility on 05/02/2024 and started his dialysis treatment on 05/02/2024. Hemodialysis orders dated 05/02/2024 showed no documented evidence of orders from Patient #5’s physician (Personnel #10) to dialyze Patient #5 in the isolation room and orders to maintain isolation precautions. Treatment sheets dated 05/02/2024, 05/09/2024 - 05/16/2024, showed no documented evidence facility staff observed and/or maintained isolation precautions during provision of care to Patient #5. On 05/17/2024 at 10:00 AM, the facility administrator (Personnel #2) confirmed the above findings. 2. Patient #9: A review of Patient #9’s clinical records showed Patient #9 was hospitalized from 03/24/2024 - 03/27/2024 for vitreous hemorrhage bilateral bleed. Patient #9 returned to the dialysis facility on 03/29/2024 for her dialysis treatment. Orders for Heparin dated 12/18/2023 - 12/16/2024 included, “ 1,000 units/2,000 units bolus Intravenous Push (IVP). A review of the treatment sheet dated 03/29/2024, included, “...Anticoagulation 12:21 PM Heparin Sodium 2,000.000 Bolus administered 2000 units...Licensed Practical Nurse (LPN) (Personnel #14)...12:13 PM Blood Pressure (BP)____, Pulse___Started....12:28 PM general assessment...no unusual finding...Registered Nurse (RN) (Personnel #3)...” There were no documented evidence facility staff called Patient #9’s physician (Personnel #10) for hemodialysis orders, clarification of orders, and for Heparin orders for post hospitalization and return to the dialysis facility on 03/20/2024. On 05/17/2024 at 12:40 PM, the facility administrator (Personnel #2) confirmed the above findings. A review of the facility’s Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg) dated 11/06/2023, included, “...Purpose: The purpose of this policy is to prevent transmission of Hepatitis B...Policy...In addition to dialysis precautions, all patients with hepatitis B infection...treated in the dialysis facility require additional infection control precautions...” A review of the facility’s Physician Order Documentation Policy dated 07/03/2023, included, “...Background...All...treatments a patient receives require an electronic order signed by the physician..general policy...Nurse practice acts require nurses to carry out treatment care medication administration, lab tests, procedures, and other treatments, based on physician orders...” A review of the facility’s Nursing Supervision and Delegation Policy dated 11/05/2023, included, “...Non-Delegated Tasks...the following tasks that may NOT be delegated...Pre treatment assessment at the patient’s first treatment back from a hospitalization...Documentation...document all findings in the patient’s medical record...””