Davita Kissimmee Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 37965 Based on observations, staff interviews, medical record reviews and review of policy and procedures the facility failed to maintain an effective infection control program by failing to ensure staff adhered to infection control policies and standards. On 06/03/24 Patient Care Technician (PCT) staff B, was observed caring for a patient in the isolation room of the facility. The patient was positive for the Hepatitis B Virus (HBV), a serious transmittable liver infection caused by the hepatitis B virus. At the time of the observation the PCT was observed to not be wearing an isolation gown. This staff member was then observed to assist with caring for patients who were identified as having a hepatitis B surface antibody of less than 10, indicating they were not immune from the virus. (Patients #3, #4 and #11). During the three day survey other infection control violations were observed to include staff members not sanitizing their hands before and after donning gloves (Staff members A and B), failing to clean stethoscopes before and after use (Staff member B and the Advanced Practice Registered Nurse), failure to ensure proper Personal Protective Equipment (PPE) use (Staff member B, Charge Nurse F), and failing to clean the top of multi-use vials of medications (Staff member F). Furthermore, the facility’s Quality Assurance Improvement Performance program failed to identify issues with infection control practices which are persistently occurring over several months. The continuous effects of the facility’s systemic failure to identify, monitor and implement infection control practices presents a risk to the patients’ health and safety and resulted in the facility failing to meet the Condition for Coverage for Infection Control. Hepatitis B Virus (HBV) is a serious infection of the liver that is transmitted via blood or other body fluids. Patients with end-stage renal disease are at risk for contracting hepatitis B virus and other infections because of their exposure to blood products and due to their compromised immune status’. This concern had the potential to affect all 106 patients in the facility. (retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936461/ on 06/04/24) The findings include: The facility failed to ensure that staff caring for Hepatitis B Virus (HBV) positive patients did not care for HBV susceptible patients at the same time for 3 of 26 patient observations (Patients #3, #4 & #11) and for 3 of 5 staff members (Staff members B, F, and the Advanced Practice Registered Nurse - APRN). (cross reference V0131) The facility failed to ensure staff assigned to work with patients on isolation for the Hepatitis B Virus (HBV) were educated on the virus, prevention of patient exposure of the virus, staff relief and proper use of personal protection equipment when caring for HBV patients for 2 of 5 staff members reviewed (Staff members A and B). (cross reference V0132) The facility failed to ensure staff utilized proper hand hygiene to minimize risk of infection and cross contamination for 2 of 5 staff observed (Staff members A & B). Center of Disease Control guidelines state proper hand washing is the most important measure against cross contamination. (cross reference V0113) The facility failed to ensure that items taken to a dialysis system station were either disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient for 2 of 5 staff observations. (Staff member A and the Advanced Practice Registered Nurse - APRN) (cross reference V0116) The facility failed to ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules for 1 of 2 patients observed for medication administration, Of a total sample of 26, (#26). (cross reference V0143) The facility failed to maintain an effective Quality Assurance Performance Improvement program by failing to continuously monitor its performance, take actions that result in performance improvements, and track performance overtime by failing to ensure monthly audits of infection control were conducted for 5 of 6 months reviewed (December, January, February, March and May) and by failing to address PHOS averages that were greater than the national average for the last 12 months. (cross reference V0638)”

“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: 37965 Based on observations, staff interviews and review of policy and procedures the facility failed to ensure staff utilized proper hand hygiene to minimize risk of infection and cross contamination for 2 of 5 staff observed (Staff members A & B). Center of Disease Control guidelines state proper hand washing is the most important measure against cross contamination. The findings include: On 06/03/24 at 11:00 AM, Patient Care Technician (PCT) B was observed providing care in an area of the facility adjacent to the isolation room. The PCT was addressing dialysis machine alarms that needed attention. The PCT walked between stations #4, #3 (located in POD A) and #24 (located in POD F). PCT B was adjusting the settings and/or resetting the alarms. When PCT B was working at the dialysis station #4, he was wearing gloves however when the alarm at dialysis machine at station 24 began to alarm, the PCT removed only one of his gloves, and with his un-gloved hand took a new glove out a box at station #24. He folded the new glove around his finder (did not put it on) and used it as a barrier to address the machine that was alarming. On 06/03/24 at 11:01 AM, Registered Nurse (RN) A was wearing gloves and assisted patient #3 (Station 8, POD B) to transfer from the wheelchair to the dialysis chair. RN A brought the wheelchair to the nurse’s station and returned to the patient without removing her gloves or performing hand hygiene before donning new gloves. She then placed the blood pressure cuff on patient #3. At 11:04 AM, RN A walked away from patient #3 and walked to the supply room after removing the glove on her left hand but kept wearing the dirty glove on her right hand. She returned to patient #3’s dialysis station with a bottle of bicarb solution (a concentrated solution that is proportionate with acid concentrate and purified water used in dialysis). The nurse obtained a new glove from the station and put it on her left hand while still wearing the original glove on her right hand. The nurse did not perform hand hygiene. On 06/03/24 at 11:37 AM, RN A was observed providing assistance to patient #3. After documenting on the computer next to the patient she was observed to don gloves and provide assistance to the patient. She did not perform hand hygiene prior to donning the new gloves. On 06/03/24 at 1:39 PM, an interview was conducted with RN A, who stated she works as a float nurse at several dialysis facilities. She had infection control training upon hire at (another Dialysis location). She also has attended In-services at other locations on sanitizing, hand washing, and wiping everything down as well as appropriate use of PPE such as gowns. She stated that she has not attended in-services at this facility. She stated that she is usually the charge nurse on the floor but had to take a POD, which has 4 chairs. On 06/03/24 at 1:48 PM, an interview was conducted with PCT B during which he stated that he has worked at the facility for just short of a year. He offered that he has had training in the (facility’s electronic) learning program with bimonthly classes on multiple topics as well as in-services on CVC (central venous catheter) catheters and infections related to CVC. He was asked about when he leaves the patient he is working with while wearing gloves and removing one glove to address the sounding alarms of another patient’s dialysis machine. He stated that he removes one glove and will take a new glove from the box and use it as a barrier but that he does not usually actually put that glove on because it is quick. He stated this is not best practice and that he will use sanitizer on the one hand but it isn’t ideal. After the interview the staff member was observed to walk into the isolation room with the white gown on, ask the patient a question and then leave. At no point was he observed to remove the white gown, don the yellow isolation gown or perform hand hygiene. On 06/04/24 at 8:38 AM, PCT B was observed to enter the dialysis treatment floor, remove a white gown from the hanging hooks by the door, walk through the treatment area and begin to provide care to the patient at station 22. He was not observed to wash his hands when entering the treatment floor and did not sanitize his hands before donning gloves to provide care to the patient at the station. Review of the Monthly Infection Control Audit (All modalities) states “Per CMS Conditions for Coverage: Surveillance for infections and other adverse events is required to monitor the effectiveness of infection control practices, as well as training and evaluation of both staff members and patients ensure that appropriate infection control behaviors and techniques are carried out. The Monthly Infection Control Audit forms for December, January and February are blank and not completed. The audit items include “Gloves worn for all patient care and machine contact.” And “Hand hygiene perform immediately upon glove removal”. Policy 1-05-01 Infection Control for Dialysis Facilities Purpose “To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment” Hand Hygiene. 1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene upon entering/exiting the patient treatment are; prior to gloving and immediately after removal of gloves; after patient and dialysis delivery system contact; after interacting with wall boxes (i.e. plugging/unplugging acid bicarb lines ...) between patient even if the contact is casual, before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” 14 Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37965 Based on observations, staff interviews and review of facility policy and procedures the facility failed to ensure that items taken to a dialysis system station were either disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient for 2 of 5 staff observations. (Staff member A and the Advanced Practice Registered Nurse - APRN) The findings include: On 06/03/24 at 10:44 AM, Registered Nurse (RN A) was observed to initiate dialysis for patient #4. The Nurse obtained a multi-use stethoscope from the nursing station and listened to the patient’s lung sounds. RN A failed to clean the diaphragm of the stethoscope and/or any other part of the stethoscope before assessing the patient. On 06/03/24 at 1:12 PM, observation of the clean sink with a full dirty biohazard waste bin pushed up against the sink with the lid open and leaning up on the sink. On 06/03/24 at 1:39 PM, an interview was conducted with RN A, who stated she works as a float nurse at several dialysis facilities. She had infection control training upon hire at (another Dialysis location). She also has attended In-services at other locations on sanitizing, hand washing, and wiping everything down as well as appropriate use of PPE such as gowns. She stated that she has not attended in-services at this facility. She stated that she is usually the charge nurse on the floor but had to take a POD, which has 4 chairs. She offered that she uses the same stethoscope for the entire shift. When asked about the observation from earlier in which she obtained a stethoscope from the nursing station that she did not clean, she stated that she did not clean it because she is the one who put it there and did not observe anyone else use it. On 06/04/24 at approximately 9:01 AM an observation was made of the Advanced Practice Registered Nurse (APRN) during which she assessed the lung sounds for the patient #14 (Station 16, POD D). She was observed to remove the stethoscope from around her neck and assess the patient’s lungs without cleaning the stethoscope prior to or after the assessment. On 06/04/24 at approximately 9:34 AM, an observation was made of the APRN during which she was standing with her computer on wheels, typing on the keypad and talking with the patient #12 at dialysis station #10. The APRN assessed the patient’s dialysis access site on her left arm using a stethoscope the APRN had removed from around her neck. At no point was the APRN observed to cleanse the stethoscope prior to placing the diaphragm on the patients access site. She was then observed to return to the stethoscope to her neck without cleansing it. On 06/04/24 At approximately 11:30 AM an interview was conducted with the APRN. She stated that she comes to the facility twice a week to assess patients. She stated she cleans her stethoscope after her shift with bleach but has been known to forget to clean it between patients. She stated that she has seen infection control violations at times but for the most part everyone does a good job. She stated she does assess the isolation patients however she makes sure those patients are seen last so she doesn’t expose other patients. At approximately 11:45 AM an Interview was conducted with the Medical Director regarding the infection control concerns identified during the survey. He offered that stethoscopes should be cleaned between each patient. He stated that he attends QA (Quality Assurance) meetings monthly. Infection Control is discussed in the meetings however no infection control concerns have been reported. No concerns were brought to his attention during the last several meetings when asked about April or March he reported he has not been told about any concerns. He stated if they had he would have addressed it immediately. A review of the personnel file for staff member A, Registered Nurse (RN), revealed that she is In Center Hemodialysis Float (ICHD) Float nurse. The job description noted under Essential Function includes “..verifying safety measures are in place and complied with ...” dated as signed on 02/05/23. Completed Annual Nurse Competency exam on 04/10/24 in (the facility’s electronic education program). In-Center Procedural Skills Verification Checklist Includes Infection Control “No stethoscope around necks while wearing gowns” proper use of PPE barrier precautions dated 10/09/23 A review of the Policy 1-05-01. Infection Control for Dialysis Facilities revealed Purpose “To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment” Hand Hygiene. 1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene upon entering/exiting the patient treatment are; prior to gloving and immediately after removal of gloves; after patient and dialysis delivery system contact; after interacting with wall boxes (i.e. plugging/unplugging acid bicarb lines ...) between patient even if the contact is casual, before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” 14 Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution.”

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 37965 Based on observation, interview and record review, the facility failed to ensure that staff caring for Hepatitis B Virus (HBV) positive patients did not care for HBV susceptible patients at the same time for 3 of 12 patient observations (Patients #3, #4 & #11) and for 3 of 5 staff members (Staff members B, F, and the Advanced Practice Registered Nurse - APRN). The findings include: Hepatitis B Virus (HBV) is a serious infection of the liver that is transmitted via blood or other body fluids. Patients with end-stage renal disease are at risk for contracting hepatitis B virus and other infections because of their exposure to blood products and due to their compromised immune status’. (retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936461/ on 06/04/24) On 06/03/24 at approximately 10:25 AM two surveyors entered the treatment floor to begin observations of care. At this time both surveyors observed PCT B in the facility’s isolation room providing care to a dialysis patient. At this time the Social Worker said the patient in the isolation room was Hepatitis B Virus (HBV) positive. She was asked if the staff member should be wearing a gown and she stated “Yes”. When asked if PCT B was providing care to other patients, outside of the isolation room, she stated, “yes”, and indicated the other patients who were being cared for by PCT B, would have immunity against HBV. On 06/03/24 at 11:00 AM, PCT B was observed providing care in an area of the facility adjacent to the isolation room. The PCT was addressing dialysis machine alarms that needed attention. The PCT walked between stations #4, #3 (located in POD A) and #24 (located in POD F). PCT B was adjusting the settings and/or resetting the alarms. When PCT B was working at the dialysis station #4, he was wearing gloves however when the alarm at station 24 began to alarm, the PCT removed only one of his gloves, and with his un-gloved hand took a new glove out a box at station #24. He folded the new glove around his finger (did not put it on) and used it as a barrier to address the machine that was alarming. On 06/03/24 at 11:40 AM staff member B, PCT was noted to be standing in the isolation room wearing the white gown used for care of non-isolation patients. He was standing approximately 3 feet from the HBV positive patient talking with the patient. On 06/03/24 at 12:40 PM, patient #11 was being treated at station 9 (POD B). Patient #11 was having an issue with confusion and attempting to get out of his dialysis chair. RN A called out for assistance from other staff members. Several staff responded including PCT B. The patient returned to baseline, at this time RN A was overheard to ask PCT B to cover her POD (POD B) of patients while she went to lunch. On 06/03/24 at 12:44 PM, PCT B assisted patient #11 (Station 9, POD B) to stand, walk to the scale to obtain post treatment weight, off of the treatment floor and out the main facility door. On 06/03/24 at 1:39 PM, an interview was conducted with RN A, who stated she works as a float nurse at several dialysis facilities. She had infection control training upon hire at (another Dialysis location). She also has attended In-services at other locations on sanitizing, hand washing, and wiping everything down as well as appropriate use of PPE such as gowns. She stated that she has not attended in-services at this facility. She stated that she is usually the charge nurse on the floor but had to take a POD, which has 4 chairs. She verified that she had asked PCT B to take over her pod while she left for lunch. She added that today was hectic and this was not the usual staff break system. She stated that she was not sure how she would know who had immunity from HBV and was not sure if she should have asked PCT B, who was assigned to work with the positive HBV positive patient on isolation, to watch her POD while she went to lunch. On 06/03/24 at 1:48 PM, during the interview with RN A, PCT B approached the nursing station and began to explain, how patients are identified as having HBV immunity. He offered a copy of the patient dialysis schedule and chair assignments, that was resting on the counter in the nursing station. He noted that in the “Notes” section on the form that the immunity levels for the patients were listed. In viewing the list, it was revealed that patient #4 had no information in the notes box to which both he and the RN stated that if the box was empty, it meant that the patient had full immunity. When shown the box for patient #11 which had a “7” he stated that a 7 meant the patient had immunity and the RN A agreed. PCT B went on to report that he has worked at the facility for just short of a year. He stated that he has had training in the STAR learning program - bimonthly classes on multiple topics. He was asked about when he leaves the patient he is working with while wearing gloves and removing one glove to address the sounding alarms of another patient’s dialysis machines. He stated that he removes one glove and will take a new glove from the box and use it as a barrier but that he does not usually actually put that glove on because it is quick. He stated this is not best practice and that he will use sanitizer on the one hand but it isn’t ideal. When asked about caring for the patient on isolation for HBV, he stated that you need to wash your hands when leaving the POD, never walk into the isolation room with a white gown, use a separate (yellow) gown, wear mask, gloves in the room and ensure that it has all the supplies, so you don’t have to leave to get it. He offered that this morning when the surveyors walked into the treatment floor he had just walked into the room with the patient. He stated that “You put on the gown when you start working with the patient.” And that staff should never wear a white gown into the isolation room. He offered in regards to the patient who had issues earlier that he responded to (patient #11) he knew that patient was immune from previously working with him. After the interview the staff member was observed to walk into the isolation room with the white gown on, ask the patient a question and then leave. At no point was he observed to remove the white gown, don the yellow isolation gown or perform hand hygiene. On 06/04/24 at 8:29 AM an observation was made of PCT C addressing a machine alarm in the isolation room with appropriate PPE. Ten minutes later at 8:39 AM, the Charge Nurse, RN F entered the isolation room and assisted the PCT with machine that continued to alarm. The Charge Nurse was observed to don a yellow isolation gown however, she did not tie it, so the gown hung open, exposing her back. She put on goggles and a surgical mask. The Charge nurse was noted to lean over the isolation patient and flush the patient’s CVC catheter dialysis access, with her body pressing against the chair with her back fully exposed. At 8:46 AM, both staff members (C & F) began to remove their PPE. However, the alarm sounded again, both staff members had removed of their face shields and the charge nurse had removed her gloves. The PCT, without facial coverings, assisted the patient to recline in her chair and then handed the charge nurse 2 flushes. The charge nurse had not put her goggles or face shield back on when she began to flush the patient’s dialysis tubing. On 06/04/24 at 8:51 AM, the charge nurse returned to the isolation room as alarms were sounding. She had on a yellow isolation gown however it was not tied in the back. At 8:54 AM, the charge washed her hands in sink in room and exited the isolation room. She donned a blue gown and returned to the medication station. Where she began to draw up medications for other patients. On 06/04/24 at approximately 9:01 AM an observation was made of the APRN during which she assessed the lung sounds for patient #14 (Station 16, POD D). She was observed to remove the stethoscope from around her neck and assess the patient’s lungs without cleaning the stethoscope prior to or after the assessment. Review of the patient schedule and assignment sheet dated 06/04/24 revealed the patient #14 was to receive dialysis for 2 hours and 15 minutes and under the “notes” section on the sheet was noted to be “<3”, indicating she was susceptible to HBV. Review of the Vaccination and Surveillance Report revealed patient #14’s HBsAB result on 11/14/23 was noted to be “<3”, indicated she was susceptible. On 06/04/24 at 9:04 AM, an observation was made of PCT C removing the isolation patient from the dialysis machine, the door to the room remained open during the removal process. On 06/04/24 at 9:15 AM, an interview was conducted with Staff member F, RN, who was observed as she prepared a medication to be given to a dialysis patient. There was a multi dose bottle of Heparin on the counter, used as a medication station. The nurse picked up the bottle and removed the heparin using 2 different syringes. She did not wipe the top of the bottle with alcohol. At this time, she was asked if she should have cleaned the top before she removed the heparin and she responded “Yes.” She was then asked if it was her normal practice not to clean the top before use and she shook her head yes. On 06/04/24 at approximately 9:34 AM, an observation was made of the APRN during which she was standing with her computer on wheels, typing on the keypad and talking with the patient #12 at dialysis station #10. The APRN assessed the patient’s dialysis access site on her left arm using a stethoscope the APRN had removed from around her neck. At no point was the APRN observed to cleanse the stethoscope prior to placing the diaphragm on the patients access site. She was then observed to return to the stethoscope to her neck without cleansing it. At this time she was asked for an interview to which she stated she was not an employee of the dialysis center and walked away. Review of the patient schedule and assignment sheet dated 06/04/24 revealed patient #12’s name had been handwritten next to the crossed-out name of patient #13. In the notes section of the schedule “9” was typed into the box. Review of the Vaccination and Surveillance Report for patient #12, whose name had been written in revealed his HBsAB result on 06/01/2024 was noted to be the following “Unknown/Results Not available - 06/01/24”. Review of the same report revealed that patient #13 who had been originally assigned was not found on the list provided by the facility. On 06/04/24 at 10:50 AM, a group interview was conducted with the Manager of Clinical Services, Regional Operations Director and Facility Administrator. At this time they were shown the patient schedule and assignment sheets for 06/03/24 and 06/04/24, the Manager of Clinical Services stated that this was the Patient Schedule and Assignment Sheet is used by staff to quickly identify the HBV immunity status for the patients receiving dialysis on that day. Each patient has a “Notes” section on the schedule that has a numeric value, which represents the Hepatitis B surface antibody (HBsAb). A HBsAb result less than 10 indicates the patient is susceptible to the virus, greater than 10 indicated immunity. She went on to state that yesterday (6/3/24) the Charge nurse should have ensured that the sheet was accurate, and that float staff were educated on the need to verify immunity status before asking staff to relieve them for breaks. She stated that the boxes that identify the patient’s immunity status should not be blank, and the form should be kept up to date with each patient’s HBV immunity status. When asked about training for staff related HBV that include isolation, and the importance of ensuring staff caring for the HBV positive patients do not care for susceptible patient, they stated they were not sure if HBV was included in the infection control training. They were again shown the schedule with multiple blank spaces, they stated that was not acceptable and the sheet should be current. When asked specifically what training staff had received on caring for a HBV patient to ensure susceptible patients are not exposed, they were unable to provide an answer. A review was conducted of the patient schedule and assignment sheet for 06/03/2024 and 06/04/2024 which revealed that the dialysis facility had three shifts on Monday, Wednesday and Friday and two shifts on Tuesday, Thursday and Saturday, for a total of 5 shifts, all 5 shifts had an assigned isolation patient at station 5 in the isolation room. For 06/03/2024 the sheet revealed three isolation patients, one patient to receive dialysis at 6:00 AM, one at 9:45 AM and one at 2:00 PM. On 06/04/2024 there were two scheduled isolation patients, one at 5:15 AM and one at 10:15 AM. Further review of the document revealed that on 06/03/2024 14 out of 69 note sections were blank on the sheet which should have contained HBsAB values to indicate immunity or susceptibility and on 06/04/2024 9 out of 20 notes sections were blank. On 06/04/24 At approximately 11:30 AM an interview was conducted with APRN. She stated that she comes to the facility twice a week to assess patients, she sees all patients. She stated she cleans her stethoscope after her shift with bleach but has been known to forget to clean it between patients. She stated that she has seen infection control violations at times but for the most part everyone does a good job. She stated she does assess the isolation patients however she makes sure those patients are seen last so she doesn’t expose other patients. On 06/04/24 at approximately 11:45 AM, an Interview was conducted with the Medical Director regarding the infection control concerns identified during the survey. He was very concerned that staff working with the isolation patients were working with patients not immune from HBV, and stated this should not happen. He stated that staff should not be working with both positive and non-immune patients and that staff that do work in the isolation room should have a full barrier of protection, gloves, masks, and gowns when in the isolation room. He offered that stethoscopes should be cleaned between each patient. He stated that he attends QA meetings monthly. Infection Control is discussed in the meetings however no infection control concerns have been reported. No concerns were brought to his attention during the last several meetings when asked about April or March he reported he has not been told about any concerns. He stated if they had he would have addressed it immediately. A record review for patient #1 revealed she was admitted to the dialysis center on 10/05/18 and was receiving dialysis treatments on Monday, Wednesday and Fridays. Review of the patient schedule and assignment sheet dated 06/03/24 revealed under the “Notes” section of the sheet indicated “.<3” indicating she was susceptible to HBV, however review of the Vaccination and surveillance Report revealed her HBsAB result on 12/11/23 was “287”. A record review for patient #2 revealed he was admitted to the dialysis center on 12/09/22 and was receiving dialysis treatments on Monday, Wednesday and Friday. On admission he tested positive for hepatitis B surface antigen (HBsAB) and assigned to the dialysis station #5, the isolation room. Review of his Vaccination and Surveillance Report revealed “Isolation Required/HBsAB>=10” 2/10/2023. Review of the patient schedule and assignment sheet dated 6/3/24 revealed he was to receive dialysis for 3 hours and under the “notes” section on the sheet “ISO” indicating he was on isolation. He was assigned in POD A with staff member B, PCT, as the staff member responsible for his care The record also revealed that he was assessed during his treatment on 06/03/24 by the APRN at 10:36 AM, as indicated by the time stamp noted next to “Created By” on the assessment. A record review for patient #3 revealed she was admitted to the dialysis center on 12/16/20 and was receiving dialysis treatments on Monday, Wednesday, and Fridays. Review of the Vaccination and Surveillance Report revealed his HBsAB result on 3/11/2024 was noted to be “<3”, indicated she was susceptible to the virus. Review of the patient schedule and assignment sheet dated 06/03/24 revealed she was to receive dialysis for 3 hours at station 8, in POD B with staff member A, RN as staff member responsible for his care. The notes section on the schedule sheet was noted “<3”. The record also revealed that he was assessed during his treatment on 6/3/24 by the APRN at 11:45 AM (1 hour and 9 minutes after the APRN assessed the isolation patient), as indicated by the time stamp noted next to “Created By” on the assessment. The assessment revealed “LUA AVC No bleeding or infection + bruit, cannulated x 2” A record review for patient #4 revealed he was admitted to the dialysis center on 01/24/2024 and was receiving dialysis treatments on Monday, Wednesday, and Friday. On admission he was noted to be “HBV Susceptible/HBsAB<10” - on 01/28/24. Review of the patient schedule and assignment sheet dated 06/03/24 revealed he was to receive dialysis for 3 hours at station 6, in POD B with staff member A, RN as staff member responsible for his care. The notes section on the schedule sheet was noted to be blank. Review of the Vaccination and Surveillance Report revealed his HBsAB result on 03/11/2024 was noted to be “7”, indicated he was susceptible. The record also revealed that he was assessed during his treatment on 06/03/24 by the APRN at 11:06 AM (30 minutes after the APRN assessed the isolation patient), as indicated by the time stamp noted next to “Created By” on the assessment. A review of the patient schedule and assignment sheet dated 06/03/24 revealed the notes section revealed “7”, indicating patient #11 was susceptible to the HBV however review of the Vaccination and Surveillance Reported revealed she was actually a 33 which indicates immunity. Review of the Monthly Infection Control Audit (All modalities) states “Per CMS Conditions for Coverage: Surveillance for infections and other adverse events is required to monitor the effectiveness of infection control practices, as well as training and evaluation of both staff members and patients ensure that appropriate infection control behaviors and techniques are carried out. The Monthly Infection Control Audit forms for December 2023, January 2024 and February 2024 are blank and not completed. The audit items include “Gloves worn for all patient care and machine contact.” And “Hand hygiene preform immediately upon glove removal”. Review of the Policy; 01-05-02 Hepatitis B Surveillance, Vaccination, Infection Control measures and isolation Guidance. Purpose “To prevent the spread of hepatitis B infections in the dialysis setting.” The policy states that if a patient has an antibody of less than 10 the patient is susceptible to the hepatitis B virus and can been seated “general population using an immune patient as a geographic buffer between any antigen positive patient. Patients who are susceptible should have monthly antigen surveillance testing and patients who are positive should be tested annually. Under the section titled “Confirmed positive” item 15.ii. “When using a designated isolation room .....A door is required to the isolation room and it must be closed during times when blood spurting or spattering is possible, for example at initiation and termination of treatment.” Under the section titled “Infection Control Measures for Confirmed Positive or Suspected/Unknown Status” item 17.a. “When entering the isolation room/area or station for any reason, physician, NPPs, Social workers, dietitians, and all other teammates will wear long-sleeved fluid resistant/fluid impervious gowns in addition to gloves, face shields, or masks and eye protection”. B. The long sleeved gown will be tied in the back and gloves will be pulled over the cuffs of the sleeves.” C. PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the room or area.” 21. A. Teammates caring for confirmed or suspected hepatitis B surface antigen positive (HBsAg) positive patients do not care for surface antibody negative (susceptible) patients simultaneously and will only be assigned to care for surface antibody positive (immune) patients.”

“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: 37965 Based on staff interview and review of personnel records, the facility failed to ensure staff assigned to work with patients on isolation for the Hepatitis B Virus (HBV) were educated on the virus, prevention of patient exposure of the virus, staff break relief and proper use of personal protection equipment when caring for HBV patients for 2 of 5 staff members reviewed (Staff members A and B). This has the potential to affect all 106 patients receiving dialysis in the facility. Hepatitis B Virus (HBV) is a serious infection of the liver that is transmitted via blood or other body fluids. Patients with end-stage renal disease are at risk for contracting hepatitis B virus and other infections because of their exposure to blood products and due to their compromised immune status’. This concern had the potential to affect all 106 patients in the facility. (retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936461/ on 06/04/24) The findings include: On 06/03/24 at approximately 10:25 AM two surveyors entered the treatment floor to begin observations of care. At this time both surveyors observed Patient Care Technician (PCT) B in the facility’s isolation room providing care to a dialysis patient. At this time the Social Worker said the patient in the isolation room was Hepatitis B Virus (HBV) positive. She was asked if the staff member should be wearing a gown and she stated “Yes”. When asked if PCT B was providing care to other patients, outside of the isolation room, she stated, “yes”, and indicated the other patients who were being cared for by PCT B, would have immunity against HBV. On 06/03/24 at 11:00 AM, PCT B was observed providing care in an area of the facility adjacent to the isolation room. The PCT was addressing dialysis machine alarms that needed attention. The PCT walked between stations #4, #3 (located in POD A) and #24 (located in POD F). PCT B was adjusting the settings and/or resetting the alarms. When PCT B was working at the dialysis station #4, he was wearing gloves however when the alarm at station 24 began to alarm, the PCT removed only one of his gloves, and with his un-gloved hand took a new glove out a box at station #24. He folded the new glove around his finger (did not put it on) and used it as a barrier to address the machine that was alarming. On 06/03/24 at 11:40 AM staff member B, PCT was noted to be standing in the isolation room wearing the white gown used for care of non-isolation patients. He was standing approximately 3 feet from the HBV positive patient talking with the patient. On 06/03/24 at 12:40 PM, patient #11 was being treated at station 9 (POD B). Patient #11 was having an issue with confusion and attempting to get out of his dialysis chair. RN A called out for assistance from other staff members. Several staff responded including PCT B. The patient returned to baseline, at this time RN A was overheard to ask PCT B to cover her POD (POD B) of patients while she went to lunch. On 06/03/24 at 12:44 PM, PCT B assisted patient #11 (Station 9, POD B) to stand, walk to the scale to obtain post treatment weight, off of the treatment floor and out the main facility door. On 06/03/24 at 1:39 PM, an interview was conducted with Registered Nurse (RN) A, who stated she works as a float nurse at several dialysis facilities. She had infection control training upon hire at (another Dialysis location). She also has attended In-services at other locations on sanitizing, hand washing, and wiping everything down as well as appropriate use of PPE such as gowns. She stated that she has not attended in-services at this facility. She stated that she is usually the charge nurse on the floor but had to take a POD, which has 4 chairs. She verified that she had asked PCT B to take over her pod while she left for lunch. She added that today was hectic and this was not the usual staff break system. She stated that she was not sure how she would know who had immunity from HBV and was not sure if she should have asked PCT B, who was assigned to work with the positive HBV positive patient on isolation, to watch her POD while she went to lunch. On 06/03/24 at 1:48 PM, during the interview with RN A, PCT B approached the nursing station and began to explain, how patients are identified as having HBV immunity. He offered a copy of the patient dialysis schedule and chair assignments, that was resting on the counter in the nursing station. He noted that in the “Notes” section on the form that the immunity levels for the patients were listed. In viewing the list, it was revealed that patient #4 had no information in the notes box to which both he and the RN stated that if the box was empty, it meant that the patient had full immunity. When shown the box for patient #11 which had a “7” he stated that a 7 meant the patient had immunity and the RN A agreed. PCT B went on to report that he has worked at the facility for just short of a year. He stated that he has had training in (the facility’s learning program) - bimonthly classes on multiple topics. He was asked about when he leaves the patient he is working with while wearing gloves and removing one glove to address the sounding alarms of another patient’s dialysis machines. He stated that he removes one glove and will take a new glove from the box and use it as a barrier but that he does not usually actually put that glove on because it is quick. He stated this is not best practice and that he will use sanitizer on the one hand but it isn’t ideal. When asked about caring for the patient on isolation for HBV, he stated that you need to wash your hands when leaving the POD, never walk into the isolation room with a white gown, use a separate (yellow) gown, wear mask, gloves in the room and ensure that it has all the supplies, so you don’t have to leave to get it. He offered that this morning when the surveyors walked into the treatment floor he had just walked into the room with the patient. He stated that “You put on the gown when you start working with the patient.” And that staff should never wear a white gown into the isolation room. He offered in regards to the patient who had issues earlier that he responded to (patient #11) he knew that patient was immune from previously working with him. After the interview the staff member was observed to walk into the isolation room with the white gown on, ask the patient a question and then leave. At no point was he observed to remove the white gown, don the yellow isolation gown or perform hand hygiene. On 06/04/24 at 10:50 AM, a group interview was conducted with the Manager of Clinical Services, Regional Operations Director and Facility Administrator. At this time they were shown the patient schedule and assignment sheets for 06/03/24 and 6/4/24, the Manager of Clinical Services stated that this was the Patient Schedule and Assignment Sheet and is used by staff to quickly identify the HBV immunity status for the patients receiving dialysis on that day. Each patient has a “Notes” section on the schedule that has a numeric value, which represents the Hepatitis B surface antibody (HBsAb). A HBsAb result less than 10 indicates the patient is susceptible to the virus, greater than 10 indicated immunity. She went on to state that yesterday (06/03/24) the Charge nurse should have ensured that the sheet was accurate, and that float staff were educated on the need to verify immunity status before asking staff to relieve them for breaks. She stated that the boxes that identify the patient’s immunity status should not be blank, and the form should be kept up to date with each patient’s HBV immunity status. When asked about training for staff related HBV that include isolation, and the importance of ensuring staff caring for the HBV positive patients do not care for susceptible patient, they stated they were not sure if HBV was included in the infection control training. They were again shown the schedule with multiple blank spaces, they stated that was not acceptable and the sheet should be current. When asked specifically what training staff had received on caring for a HBV patient to ensure susceptible patients are not exposed, they were unable to provide an answer. The Regional Director of Operations and the Manager of Clinical Services stated that they were unsure who monitors the APRN for Infection Control, the nurses do not audit her. They stated she is an affiliate (the physician group) and not an employee of the dialysis center. They reported she comes 6 days a month and the physician comes two times a month. They stated again that she is not a (dialysis center) employee. A review of the personnel file for staff member A, Registered Nurse (RN), revealed that she is In Center Hemodialysis Float (ICHD) Float nurse. The job description noted under Essential Function includes “..verifying safety measures are in place and complied with ...” dated as signed on 02/05/23. Completed Annual Nurse Competency exam on 04/10/24 in (the facility’s electronic education program). In-Center Procedural Skills Verification Checklist Includes Infection Control “No stethoscope around necks while wearing gowns” proper use of PPE barrier precautions dated 10/09/23. There was nothing in the employee’s file to indicate she had been provided education on HBV or infection control measures to ensure susceptible patients were not exposed during treatment. A review the personnel file for Staff member B, patient care (PCT) revealed a “Verification of Competency for New Non-experienced in-center Teammate” which offers that staff member B, PCT natures of the Procedural Skills Verification Checklist”. The form indicates that the employee received a score of 85% on the final exam. Signed by the Clinical New Teammate Training Instructor on 09/13/23; The Medical Director on 12/24/23; and the Administrator 10/24/23. In-Center Annual Procedural Skills Verification Checklist dated 03/14/24 states under Infection Control the employee demonstrates appropriate hand hygiene, proper use of PPE barrier precautions, etc. There was nothing in the employee’s file to indicate he had been provided education on HBV or infection control measures to ensure susceptible patients were not exposed during treatment.”

“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: 39943 Based on observations and interviews the facility failed to ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules for 1 of 2 patients observed for medication administration, Of a total sample of 26, (#26). Findings: On 06/04/24 at 9:15 AM, An observation of the Charge Nurse F drawing up heparin to be given to patient #26 revealed an open multi dose vial of heparin sitting on the medication counter. The nurse sanitized her hands, donned gloves and picked up the vial, using a clean syringe she punctured the septum (top rubber stopper) of the heparin and drew up the heparin into the syringe. She repeated the same steps with another syringe. She then labeled the two syringes and taped them together and placed them on the counter. She did not wipe the septum with an alcohol wipe prior to drawing the heparin from the vial. When asked if she should have cleaned the septum of the bottle prior to drawing up the heparin she said yes. When asked if it was her normal practice to draw medications from a vial without first cleaning the septum, she shook her head yes. On 06/04/24 at 11:15 AM, the Director of Clinical Operations acknowledged that all vials should be cleaned with alcohol prior to inserting a needle into the septum. Review of the policy and procedure titled, “Infection Control for Dialysis Facilities”, revised April 2023, revealed its purpose was: “To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment.””

“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: 13640 Based on observations, interviews, record reviews and a review of facility documentation, the facility failed to ensure that equipment in the form of Vacutainer blood collection tubes and culture vials were maintained with respect to expiration dates and failed to ensure the correct transfer procedure was used for a mechanical lift in accordance with the manufacturer’s recommendations for patient safety for 1 of 1 patient who required the use of a mechanical lift during transfers of a total of 26 sampled patients (#6). Findings: 1. During observations of the lab area of the facility on 06/03/24 at approximately 10:36 AM, the contents of cabinets were examined. Inside the cabinets the following was discovered: (1) four each of boxes which respectively contained 100 BD Vacutainer blood collection tubes. Each of the boxes were labeled with the expiration date of “2024-04-30”; (2) eight each of 40 ML (milliliters) BD Bactec Lytic/10 Anaerobic/I culture vials which were labeled with the expiration date of “2024-05-13”; (3) seven each of 30 ML BD Bactec Plus Aerobic/F culture vials which were labeled with the expiration date of “2024-05-13”; and (4) four bags which each contained two 40 ML (milliliters) BD Bactec Lytic/10 Anaerobic/I culture vials and two 30 ML BD Bactec Plus Aerobic/F culture vials; all labeled with the expiration date of “2024-05-27.” During an interview with the Administrator on 06/03/24 at approximately 10:50 AM, he confirmed that the expiration dates on the above listed items had passed. Review of facility policy Infection Control for Dialysis Facilities revealed the following: “Supplies will be stored in a manner that maintains their integrity.” The facility was not in compliance with this policy as the expiration status of the stored items compromised their integrity. 39943 2. On 06/04/24 at 10:30 AM, patient #6 was seen sitting in his wheelchair with a mechanical lift sling under him. Patient Care Technician (PCT) B brought a mechanical lift over to the wheelchair which was positioned in front of the treatment chair. PCT B was the only staff person assisting the transfer using the mechanical lift. The PCT manually rolled the mechanical lift toward the wheelchair and connected the sling to the lift. The PCT lifted the patient out of the wheelchair and he was suspended in the air sitting in the sling. PCT B then pushed the wheelchair out of the way and turned the mechanical lift toward the treatment chair. As they approached the treatment chair, PCT B guided the patient in the sling over the chair using his left hand to hold the sling and pushed the lift closer to the chair. He lowered the patient into the chair using the controls on the lift with his right hand and he guided the sling with his left hand. No other staff person stood near the dialysis chair during the transfer to guide the sling to the correct position and stabilize any patient movements the patient may have had as he was suspended in air about 5-6 feet off the ground above the treatment chair. The patient held onto the sling with his hands and was lowered to his chair. On 06/04/24 at 10:40 AM, PCT B explained that he did not need another staff member to assist with the mechanical lift transfer. He said he was able to transfer the patient without any assistance and did not believe it was necessary for two people to perform the transfer. At the time of the transfer there were two other PCTs on the floor and two nurses. No other staff member came to the area to ask if the PCT needed assistance. On 06/04/24 at 11:15 AM, the Regional Operations Director stated a mechanical lift requires two people to transfer a patient. She said, “ A one person transfer is not acceptable.” Review of the facility policy and procedure, Use of a Mechanical Device for Lifting Patients,” initiated March 2008 and revised April 2023 read: “Two teammates are required when utilizing mechanical lift devices. With one teammate operating the lift, and one teammate assisting the patient, slowly lower the patient down while the teammate assisting the patient verifies the patient is as far back in the chair as possible.” Review of the mechanical lift’s manufacturer’s instructions for use and patient safety included the following: “ . . . observe a trained team of experts perform the lifting procedures and then perform the entire lift procedure several times with proper supervision and a capable individual acting as a patient.” The facility could not provide any documented evidence that they had trained PCT B in the use and safety operation of the center’s mechanical lift.”

“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: 13640 Based on interviews, record reviews and a review of facility documentation, the facility failed to provide the necessary care and services including a corrective plan to manage the patient’s volume status concerning a failure to meet target weights (estimated dry weights) and obtain treatment for a prescribed duration in hours in one of ten sampled patients. (#10) Findings: A review of the medical record of patient #10 revealed physician orders for hemodialysis treatment of 05/08/24 which read: “Dialysate flow rate (DFR) 500 ML (milliliters) /min (minute).” A review of the hemodialysis Treatment Details Report for 05/21/24 revealed that treatment started at 11:26 AM. It indicated the performance of a DFR of 500 from 11:26 AM through 1:26 PM. After this, the next DFR entry was at 3:26 PM, a few minutes before the end of the treatment at 3:32 PM. Thus, approximately one hour had passed between entries concerning the DFR. A review of the hemodialysis Treatment Details Report for 05/23/24 revealed that treatment started at 11:29 AM. It indicated the performance of a DFR of 500 from 11:29 AM through 2:32 PM. After this, the next DFR entry was at 2:59 PM, for a DFR of 730. There were no additional DFR entries until the termination of treatment at 3:23 PM. Approximately one hour had passed between entries indicating a rate of 500 and an intervening rate of 730 was entered. There were no justifications for the absence of entries in the above stated time ranges or the entry of 730 which was not in compliance with orders. A review of facility policy Pre-Intra-Post Treatment Data Collection, monitoring and Nursing Assessment revealed the following: Vital signs and treatment monitoring: . . . Non-nocturnal treatments are completed at least every thirty (30) minutes, At a minimum, document the following: . . . dialysate flows . . . “ The facility was not in compliance with this policy. Interview with the Administrator on 06/04/24 at approximately 3:30 PM confirmed the findings.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 37965 Based on Infection Control Audit and national phosphorus (PHOS) level reviews, and interviews the facility failed to maintain an effective Quality Assurance Performance Improvement program by failing to continuously monitor its performance, take actions that result in performance improvements, and track performance overtime by failing to ensure monthly audits of infection control were conducted for 5 of 6 months reviewed (December, January, February, March and May) and by failing to address PHOS averages that were greater than the national average for the last 12 months. The findings include: A review was conducted of the Training/Inservice Documentation Form dated 2/28/24, revealed that 9 employees, including the current Facility Administrator, had attended an Inservice with topics that included the initiation of Monthly Infection Control Audits. Attached to the form was a document titled Monthly Infection Control Audits “(All modalities)” and states “Per CMS Conditions for Coverage: Surveillance for infections and other adverse events is required to monitor the effectiveness of infection control practices, as well as training and evaluation of both staff members and patients ensure that appropriate infection control behaviors and techniques are carried out.” The forms state under the title “How to Create an Improvement Plan [If applicable]” there is a bulleted list that offer, “Review audits for areas of deficiencies/unmet. Compare to previous months to look for trends.” “Collaborate with team to develop solutions ...” and “Monitor improvement and evaluate plan for modification if necessary. Re-evaluate root cause or search for other root cause. Reach out to MCS and/or IPM for assistance with plan development/modification. Keep it going until everyone agrees you have sustainability ...that’s a minimum 3 months in a row.” Under the month of March focus areas included Hand Hygiene (all); Station/training Disinfection (all), Physical plant and Environment (all) and CVC Termination (HD).” Review of the Monthly Infection Control Audit (All modalities) states “Per CMS Conditions for Coverage: Surveillance for infections and other adverse events is required to monitor the effectiveness of infection control practices, as well as training and evaluation of both staff members and patients ensure that appropriate infection control behaviors and techniques are carried out. The Monthly Infection Control Audit forms for December 2023, January 2024 and February 2024 were blank and not completed. The audit items include “Gloves worn for all patient care and machine contact.” And “Hand hygiene preform immediately upon glove removal”. A review of the Monthly Infection Control electronic audits from March to current, provided by the facility Administrator revealed that for the month of April one staff member had been audited for adherence to infection control standards without identified concerns. No other Monthly Infection Control electronic audits forms were provided. On 06/04/24 at 10:50 AM, a group interview was conducted with the Manager of Clinical Services, Regional Operations Director and Facility Administrator. They reported that the nurses are in-charge of the Infection Control program. There are two registered nurses (RN) one works as the charge nurse and the other one is assigned to work with patients in a POD. The charge nurse oversees water checks, administers medications, answers the telephone and conducts patient assessments. The nurse with an assigned POD assists with patient assessments, medications administration and helps the charge nurse manage the floor. Both RNs monitor infection control for all staff. The nurses do the audits or assign a designee. The audits should be done monthly or more often if there is a trend or more concerns. Audits for Dec, Jan and Feb were not done and there was a lot of turnovers in nurses. Transition over last 6 months previous facility administrator who left in October after 6 years, and then there was an interim administrator until middle of April. On 06/04/24 at approximately 11:45 AM, an Interview was conducted with the Medical Director. He stated that he attends QAPI meetings monthly. Infection Control is discussed in the meetings however no infection control concerns have been reported. No concerns were brought to his attention during the last several meetings and he had not been told about any concerns. He stated if they had been reported he would have addressed it immediately. On 06/05/24 at approximately 2:25 PM, an interview was conducted with the Administrator during which he provided details on the Quality Assurance Performance Improvement program (QAPI). He reported that he is the lead for QAPI and that the facility conducts infection control audits monthly. He stated that these audits review much more than previous infection control audits and allows for everything be on one sheet. The audits in the past were completed by the nurse however going forward it will be the Administrator and the Nurse manager. Any concerns will be addressed immediately and will be discussed with the entire team to include the Medical Director weekly. During the meeting the Administrator used a large monitor to display graphs for trends they were following, all of which demonstrated positive trends related patient infections and hospitalization rates. However, when asked if these rates were specific to the dialysis center only or if these trends were compared to the state and national averages, he stated they were specific only to this dialysis location. When asked how the facility compared on a national level, since the facility had higher hospitalization with septicemia than the national average (17% vs 12%), he changed the view on the monitor to a national comparison and quickly began to scroll through the comparative results. He was asked to stop scrolling. At this time the monitor screen was on PHOS (Phosphorus) highlighted in bright red. Next to PHOS was a percentage value of 26.7, also noted in bright red and with the national level noted next to this value of 12.6.(Hemodialysis patients with serum phosphorus greater than 6.5 mg/dL were reported to have a 27% higher mortality risk than patients with serum phosphorus between 2.4 and 6.5 mg/dL.) He then was asked if he trended this overtime, he changed the view on the monitor again which showed data going back 12 months all of which had numbers showing in red color indicating PHOS levels greater than the national average of 12.6. At this time the administrator stated that it would be the nursing staff and the dietitian who would address this and create a performance improvement plan. He stated he addressed the hospitalizations and saw positive results on the clinical level and has not worked at the facility long enough to bring down the PHOS levels but was aware of the concern, and it is on the list for review. He stated he has only been here a short time and cannot address everything but he is working on it.”