Vistacare Dialysis Center

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 39223 Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure the quality of water and dialysate provided to hemodialysis patients is within the Association for the Advancement of Medical Instrumentation’s (AAMI’s) standards by failing to ensure: 1.) accurate testing of the water treatment system for chlorine/chloramine removal (Tag V-196); 2.) microbiological testing of the Reverse Osmosis (RO) machine and water distribution system are completed monthly for two of six months reviewed (Tag V-213); 3.) the RO machine is disinfected in accordance with the Manufacturer’s Instructions for Use (MFU), and water distribution pipes are disinfected at least monthly (Tag V-219); 4.) the bicarbonate tank is labeled accordingly, to ensure the proper storage time of the bicarbonate (Tag V-233); 5.) microbiological samples are collected in the “worst case” scenario before sanitation and disinfection of the water treatment system in one of two disinfections completed between March 2024 and September 2024 (Tag V-254). Findings include: The above findings (Tag V-213) resulted in an Immediate Jeopardy (IJ) on 10/03/24 at 2:10 PM. The IJ template was provided to Staff 1, the Facility Administrator, on 10/03/24 at 2:21 PM and a removal plan was requested. An IJ removal plan was provided by the facility on 10/03/24 at 02:35 PM, and was accepted. On 10/04/24 at 10:40 AM, it was determined that the facility took the following steps to remove the immediacy of the IJ: The biomedical team received education, as evidenced by sign in sheets and interview with the biomedical team. RO and Loop were disinfected with Minncare and documented on the RO disinfection log. Documented evidence that a culture and endotoxin specimen was drawn prior to disinfection on 10/03/24 was also reviewed. Cross reference: 42 CFR 494.40 (a) - ANSI/AAMI RD 52:2004 Requirements as Adopted by Reference”

“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: 48966 Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that two of two emergency evacuation boxes contained all necessary equipment in the event of an emergency. Findings include: On 09/30/24 at 1:04 PM, a review of the contents of the emergency evacuation box in the Annex area revealed that the following items on the “Emergency Evacuation Box Monthly Checklist,” signed 09/02/2024, were not present: - 10 IV (intravenous) sets - 6 arm clamps At 1:18 PM, a review of the contents of the emergency evacuation box revealed that the following items on the “ Emergency Evacuation Box Monthly Checklist,” signed 09/02/2024, were not present: - 10 IV sets - 6 arm clamps - 10 catheter dressings During an interview on 09/30/24 at 1:50 PM, Staff 3, Clinic Manager, explained the Registered Nurse checks the emergency evacuation box monthly. S3 confirmed when the “Emergency Evacuation Box Checklist” is signed off by the RN for the month it indicates that all contents are present. A review of the facility policy titled, “Emergency Disconnect Kits & Emergency Evacuation Box,” effective date 02/2020, stated, “... Emergency Supply Box 1. The emergency box is checked every month for contents and expiration dates ...” N.J.A.C. 8:43A-15.1(d)”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 50912 Based on three of five observations of cleaning and disinfection of dialysis stations, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that all surfaces within the dialysis station are cleaned and disinfected after patient use to prevent cross contamination. Findings include: On 09/30/24 at 9:56 AM, Station 5 was set-up for a new patient. This was confirmed with Staff (S) 4, Registered Nurse (RN). S4 stated that S5, Patient Care Technician (PCT), cleaned the station according to the facility policy twenty minutes earlier. The chase wall on Station 5 contained two blue colored telephone internet wire cables, two cloth curtain tie backs, and a clear air freshener bottle. These findings were confirmed with S4. During an interview at 10:04 AM with S4, he/she stated, “Those items should have never been left there.’’ S4 then removed all the items found on the chase wall, but did not clean the top surface area of the chase wall where the items were located. During an interview at 10:20 AM with S5, he/she stated “Yes, I cleaned the chair, hemodialysis machine and the chaise wall on Station 5 with 1:100 bleach solution.” When asked about the items left on the chaise wall, S5 stated, “I must have forgotten about it ...” 51227 On 09/30/24 at 10:03 AM, S6, RN, entered Station 11 and proceeded to use a bleach-soaked cloth to clean the dialysis station. S6 did not clean the chaise wall surface located within the dialysis station. During an interview at 10:07 AM, S6 stated he/she was not sure if the chaise wall needed to be cleaned between each patient. S6 stated, “I don’t know what the policy says, but I usually wipe the chaise wall down at the end of each day.” 39223 On 09/30/24 at 10:10 AM, S14, PCT, wiped the patient recliner chair and chase wall of Station 18. S14 then removed the prime bucket from the hemodialysis treatment machine and exited Station 18 with it. S14 did not clean and disinfect the hemodialysis machine prior to removing the prime bucket. S14 proceeded to go to a Dirty Sink and began to clean and disinfect the prime bucket. At 10:14 AM, S6, RN, escorted a patient by wheelchair into Station 18. S6 then assisted the patient into the patient recliner chair. The hemodialysis machine was not cleaned and disinfected prior to the new patient entering the station. After becoming aware that the hemodialysis machine was still dirty, S6 used bleach soaked cloths to clean and disinfect the machine. During an interview at 10:25 AM, when asked about bringing the patient into the dirty station, S6 stated that it was a mistake. S6 stated that when S14 let him/her know that the hemodialysis machine was still dirty, he/she then cleaned and disinfected it. The facility policy titled, “Infection Control for Dialysis Facility,” revised April 2019, stated, “... C. Facility Hygiene: 1. Items taken into the patient station will be disposed of, dedicated for use on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. ... 8. Equipment such as the dialysis machine, the dialysis chair and side tables including opening of the chair to reach crevices, blood pressure equipment, television controls, outside of sharps containers, IV poles and pumps, as well as all work surfaces will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient, throughout the work day, and after each treatment. ...” N.J.A.C. 8:43A-24.8(b)”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 39223 Based on document review, review of facility policy, and staff interview, it was determined that the facility failed to ensure that seven of 61 patients received routine Hepatitis B testing. Findings include: Reference: The Center for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), dated 04/27/01, “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” states, “ ... Routine Serologic Testing ... The HBV serologic status (i.e., HBsAg, total anti-HBc, and anti-HBs) of all patients should be known before admission to the hemodialysis unit. ... HBV-Susceptible Patients. Vaccinate all susceptible patients (see Hepatitis B Vaccination). Test susceptible patients monthly for HBsAg, including those who a) have not yet received hepatitis B vaccine, b) are in the process of being vaccinated, or c) have not adequately responded to vaccination. ... “ A review of the facility Hepatitis B monitoring labs for patients from August 2023 to August 2024 revealed the following: Patient (P) 8 had a Hepatitis B surface antibody (HBsAb) level of less than four on 01/11/24. This indicated that the patient was susceptible to contracting the Hepatitis B Virus (HBV). There was no evidence of monthly Hepatitis B surface Antigen (HBsAg) testing for May 2024. P9 had a HBsAg less than four on 03/14/24. This indicated that the patient was susceptible to contracting the HBV. There was no evidence of monthly HBsAg testing for May 2024. P10 had a HBsAg less than four on 09/13/23. This indicated that the patient was susceptible to contracting the HBV. There was no evidence of monthly HBsAg testing for January 2024. P11 had a HBsAg of six on 03/14/24. This indicated that the patient was susceptible to contracting the HBV. There was no evidence of monthly HBsAg testing for May 2024. P12 had a HBsAg of eight on 01/11/24. This indicated that the patient was susceptible to contracting the HBV. There was no evidence of monthly HBsAg testing for May 2024. P13 did not have Hepatitis B Core Antibody (HBcAb) testing done prior to admission on 11/20/23. There was no documented evidence that P13 had HBcAb testing completed before or since admission. P5 did not have HBcAb testing done prior to admission on 06/26/23. There was no documented evidence that P5 had HBcAb testing completed before or since admission. On 10/01/24 at 12:45 PM, the above findings were reviewed with Staff (S) 3, Clinic Manager, who confirmed that the above lab results were missing. Facility policy titled, “Hepatitis Surveillance Vaccination, and Infection Control Measures,” effective April 2019, stated, “... Policy: A. Hepatitis B Testing 1. Prior to admission, patients will be screened for: Hepatitis B Surface Antigen (HBsAg) Total Hepatitis B Core Antibody (total snit-HBc [sic] or HBcAb) Hepatitis B Surface Antibody (HBsAb or anti-HBs) ... 6. Monthly hepatitis B surface antigen (HBsAg) testing will be completed on patients who are susceptible or not immune to hepatitis B infection, including non-responders to the vaccine. ...” N.J.A.C. 8:43A-24.4(b)”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 37656 Based on one of two observations of initiation of dialysis through a central venous catheter (CVC), staff interview, and a review of facility policy and procedure, it was determined that the facility failed to ensure that staff maintained aseptic technique for the care of the CVC during the procedure to prevent catheter-related infections. Findings include: On 09/30/24 at 11:10 AM, Staff (S) 7, Registered Nurse, was observed during initiation of dialysis through a CVC at Station 13. S7, with gloves on, held the patient’s shirt with his/her left gloved hand, removed the dressing, and cleaned the site with an alcohol swab two times at 30 seconds each with the right hand, then released the shirt from his/her left hand while stating that he/she will allow the alcohol to dry for 30 seconds. The shirt touched the cleaned exit site. S7 then stepped out of the station to retrieve a tegaderm dressing, performed hand hygiene and donned a pair of gloves, lifted the shirt again with the left hand and applied the tegaderm on the CVC exit site. S7 did not re-clean the exit site after the shirt touched it, and before applying the dressing. Upon interview at 11:20 AM, S7 stated that he/she should have clamped the shirt to hold it in a way that it would not drop on the cleaned site. S7 also stated that he/she will educate the patient to wear clothing that will be easy for them to access the site. A review of the facility policy titled, “Predialysis Central Venous Catheter (CVC) Care,” effective date 2/2020, stated, “... Procedure ... 3. Use Dialysis Precautions and clean technique throughout the procedure. ...” N.J.A.C. 8:43A-24.8(b)”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 39223 Based on one of one observation of total chlorine testing, staff interview, and review of facility documents, it was determined that the facility failed to ensure accurate testing of the water treatment system for chlorine/chloramine removal. Findings include: A review of the RPC E-Z Chek Sensitive Total Chlorine Test Strip instructions for use stated, “... Test Procedure ... 4) Wait 20 seconds for the test strip to develop. ... 5) After the 20 second wait period, immediately compare the strip color to the K100-0118 or K100-0118F color chart to determine the Total Chlorine level in the sample. ...” On 09/30/24 at 12:15 PM, Staff (S) 18, Patient Care Technician, and S9, a Registered Nurse, performed a test for total chlorine levels in the Water Treatment Room. S18 obtained a sample of water and after filling and dumping the cup with water three times, S18 dipped a RPC E-Z Chek Sensitive Total Chlorine Test Strip into the water sample. S18 then removed the strip from the water and together with S9, immediately compared the test strip color to the color chart to determine the level of chlorine. S18 and S9 did not wait 20 seconds to compare the strip to the color chart. This was not in accordance with manufacturer’s instructions for use. During an interview immediately after the observation, S18 and S9 stated that they do not need to wait to read the test results. After reviewing the manufacturer’s instructions for use of the RPC E-Z Chek Sensitive Total Chlorine Test Strip, S18 stated that he/she should have waited 20 seconds before comparing the test strip color to the color chart. S18 and S9 then proceeded to re-test with a new sample of water and waiting the 20 seconds for the test strip color to develop. N.J.A.C. 8:43A-24.4(a)”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. Bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 39223 Based on a review of facility documents and staff interviews, it was determined that the facility failed to ensure that microbiological testing of the Reverse Osmosis (RO) machine and water distribution system are completed monthly for two of six months reviewed. Findings include: The microbiological sampling schedule for the RO and water distribution system and the test results for March 2024 through September 2024 were provided for review. The following was revealed: On 03/14/24, the following areas were tested for microbiological testing: Distribution Return #1, Distribution Return #2, Granuflo Feed, Bicarb Feed, and RO Feed. There was no documented evidence that the above listed areas had microbiological samples drawn and resulted for the month of April 2024. On 08/12/24, the following areas were tested for microbiological testing: Distribution Return #1, Distribution Return #2, Granuflo Feed, Bicarb Feed, and RO Feed. There was no documented evidence that the above listed areas had microbiological samples drawn and resulted for the month of September 2024. A request to interview the main Biomedical Technician (BMT) was made on 09/30/24, 10/01/24, 10/02/24, and 10/03/24 to Staff (S) 1, Facility Administrator. The interview was unable to be accommodated. A request for the policy and procedure for drawing microbiological samples was made on 10/01/24, 10/02/24, and 10/03/24 to S1, who was unable to provide. During a telephone interview on 10/02/24 at 1:11 PM, S12, Medical Director, stated that he/she reviews the microbiological results during QAPI review. S12 stated that there has been no concerns with microbiological testing because “they have all been clean.” S12 stated that he/she discusses with the Biomedical Technician any concerns from their standpoint. N.J.A.C. 8:43A-24.10(a)”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 39223 Based on review of facility documents and staff interviews, it was determined that the facility failed to ensure that the Reverse Osmosis (RO) machine is disinfected in accordance with the Manufacturer’s Instructions for Use (MFU), and water distribution pipes are disinfected at least monthly. Findings include: On 09/30/24 at 2:00 PM a request was made to review the “RO [Reverse Osmosis] Cleaning/Disinfection Log.” On 10/03/24 at 10:16 AM, the log was provided for review. The log indicated that between March 2024 and 10/03/24, the day of survey, the RO Machine was disinfected with Minncare on the following dates: 03/13/24 and 06/14/24. There was no documented evidence that the RO Machine was disinfected in September 2024. There was no documented evidence that the water distribution pipes were disinfected during the months of March through 10/3/24. During a telephone interview on 10/02/24 at 1:11 PM, Staff (S) 12, Medical Director, stated that he/she reviews the microbiological results during QAPI review. S12 stated that there has been no concerns with microbiological testing because “they have all been clean.” S12 stated that he/she discusses with the Biomedical Technician any concerns from their standpoint. During an interview on 10/03/24 at 10:32 AM, S13, Biomedical Technician (BMT) who is currently on orientation, stated that he/she spoke with the current BMT by telephone. S13 stated he/she was informed that the facility disinfected the RO with high and low pH and Minncare on a quarterly basis. S13 stated that the loop is disinfected monthly with bleach. S13 could not provide evidence that the disinfections had been performed as described. Requests to interview the current BMT on 09/30/24, 10/01/24, 10/02/24, and 10/03/24 could not be accommodated. A review of the MAR COR PURIFICATION 23G-Series RO System Manufacturer’s Instructions for Use, dated 01/23/2012, stated, “... 5.3 Monthly Requirements ... 2. Disinfect the RO machine. The RO machine should be disinfected monthly after initial start up. As the system is operated for a period of time, it may be possible to extend the period of time between disinfections (under NO conditions should the period between disinfections exceed 3 months) ...” N.J.A.C. 8:43A-24.10(a)”

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 39223 Based on one of two observations of the bicarbonate storage tank, staff interview, and review of facility documents, it was determined that the facility failed to ensure the bicarbonate tank is labeled accordingly, to ensure the proper storage time of the bicarbonate. Findings include: On 10/01/24 at 2:20 PM, the Water Treatment Room was toured in the presence of Staff (S) 13, a Patient Care Technician (PCT). The bicarbonate storage tank had a sign on it, indicating the bicarbonate was prepared on 09/30/24 at 04:40 AM. During an interview at the time of discovery, S13 stated that he/she did not mix the current bicarbonate batch, but he/she knew that it was made on 10/01/24 by the opening PCT. During a telephone interview on 10/01/24 at 2:30 PM, S11, the opening PCT, stated that he/she had mixed the bicarbonate batch that morning, and while he/she documented it in the log book, he/she forgot to update the sign. A review of the “Bicarbonate Mixing & Disinfection Log” for 10/01/24 indicated that the current Bicarbonate batch was mixed on 10/01/24 at 04:00 AM. On 10/01/24 at 2:30 PM, a request for a facility policy on the Bicarbonate Mixing and the Manufacturer’s Instructions for Use was made to S1, Facility Administrator. S1 was unable to provide.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 39223 Based on review of facility documents and staff interview, it was determined that the facility failed to ensure that microbiological samples are collected in the “worst case” scenario before sanitation and disinfection of the water treatment system in one of two disinfections completed between March 2024 and September 2024. Findings include: A review of the “RO [Reverse Osmosis] Cleaning/Disinfection Log” indicated that between March 2024 and September 2024, the RO Machine and water distribution system were disinfected with Minncare on 03/13/24 and 06/12/24. A review of the microbiological test results for March 2024 through September 2024 indicated that samples for testing of the RO and water distribution system were drawn on 03/14/24. This was after disinfection was completed. A request for the policy and procedure for obtaining microbiological samples was made to Staff (S) 1, Facility Administrator, on 10/02/24 and 10/03/24. S1 was unable to provide. N.J.A.C. 8:43A-24.10(a)(2)”

“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: 48966 Based on two of two observations of the utility room and staff interview, it was determined that the facility failed to ensure supplies are monitored and discarded according to the manufacturer’s expiration dates. Findings include: On 09/30/24 at 10:50 AM, in the Clean Utility Room where supplies were stored, in the cabinet above the clean sink, on the first shelf, was a box of Abbott Binax Now Covid-19 Antigen testing kits with a manufacturer’s expiration date of 1/19/24. On the second shelf were six bags each containing a set of blood culture bottles that were expired. The twelve blood culture bottles had a manufacturer’s expiration dates of 6/19/24, 7/31/24, and 9/25/24. During an interview at 11:06 AM, Staff (S) 3, Clinic Manager, confirmed the expired supplies. When asked who is responsible for checking for expired supplies, S3 said the Pharmacy Consult. When asked if the staff on-site check for expired supplies, S3 responded the Registered Nurses and S3 check for expired supplies, but it has been a couple of months since the last time the supplies were audited. On 09/30/24 at 2:15 PM, 10/2/24 at 2:04 PM, and 10/4/24 at 1:50 PM, a request was made to S1, the Facility Administrator, for the Storage of Supplies Policy, but none was provided. 50912 On 09/30/24 at 10:30 AM, in the Clean Utility Room, on the top left drawer of the countertop next to a clean sink on the right side was the following blood specimen tubes with the manufacturer’s expiration dates: Three red-top, 5 ml (milliliter) blood specimen tubes with an expiration date of 06/13/24. Three tiger-top, 8.5 ml blood specimen tubes with an expiration date of 04/20/24. Three yellow-top, 5 ml blood specimen tubes with an expiration date of 07/30/24. One purple-top, 3 ml blood specimen tube with an expiration date of 08/31/24. Two green-top, 5 ml blood specimen tubes with an expiration date of 04/30/24. Upon interview at 10:48 AM, Staff (S) 3, Clinic Manager, stated, “Oh, they are expired, we usually check and get rid of them routinely.” S3, confirmed that the blood specimen tubes were expired and discarded them after interview. A review of the facility policy titled, “Infection Control For Dialysis Facility,” effective date 04/2019, stated, “... B. Staff/Patient Safety: 6. The expiration date will be checked on all disposable supplies before the package is opened and the contents are used. 7. The contents of packages will not be used beyond the expiration date on the package ...” On 09/30/24, a request was made for a specific facility storage and supply policy and procedure from S3 at 10:50 AM and 1:30 PM, but none was provided. N.J.A.C. 8:43A-24.11(c)”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 48966 Based on one of one newly admitted patient’s medical record review (Patient (P) 4), staff interview, and review of facility documents, it was determined that the facility failed to ensure that all newly admitted patients were informed of their rights and responsibilities upon admission. Findings include: A review of P4’s medical record revealed that P4 was admitted on 07/11/24. The admission document pertaining to “Patient’s Bill Of Rights & Responsibilities,” was not signed by the patient and/or their representative within the first six treatments after admission. During an interview on 10/1/24 at 3:10 PM, S1, Facility Administrator, confirmed the required admission packet was not in P4’s chart. S1 explained that every new admission gets an admission packet and needs to sign the “Patient Welcome Packet Consent” to show that the patient received the information. S1 stated, “for some reason this patient did not have the “Patient Welcome Packet Consent” signed sheet in his/her chart along with the missing consents.” S1 explained that the Registered Nurse on the hemodialysis floor is responsible for obtaining the signed consents and completing the entire admission packet. A review of the facility policy titled, “Admission Policy,” effective 01/01/2023, stated, “... Procedure: Upon admission (within the first six (6) treatments after admission) to this Dialysis Services Facility, patients and/or their representative shall be informed of their rights (including their privacy rights) and responsibilities when they begin their treatment. This facility shall protect and provide for the exercise of those rights. Each patient shall be given written materials addressing Patient Rights and Responsibilities. Staff shall document in the patient’s medical record that this material was given to the patient ...” N.J.A.C. 8:43A-16.2(a)(1)”

“PR-CAN HAVE ADVANCE DIR,TOLD FAC AD P&P CFR(s): 494.70(a)(6) The patient has the right to- (6) Be informed about his or her right to execute advance directives, and the facility ’ s policy regarding advance directives; This Standard is not met as evidenced by: 48966 Based on one of one newly admitted patient’s medical record review (Patient (P) 4), staff interview, and review of facility documents, it was determined that the facility failed to ensure that all newly admitted patients are informed of the right to execute an advance directive. Findings include: On 10/01/24, a review of the P4’s medical record lacked documentation of the “Advance Directive Assessment Form” and failed to contain the signed “Patient Welcome Packet Consent” to show P4 received the information. During an interview on 10/01/24 at 3:10 PM, S1, Facility Administrator, confirmed the required admission packet was not in P 4’s chart. S1 explained every new admission gets an admission packet and needs to sign the “Patient Welcome Packet Consent” to show that the patient received the information. S1 stated, “for some reason this patient did not have the “Patient Welcome Packet Consent” signed sheet in his/her chart along with the missing consents and documents.” S1 explained that the Registered Nurse on the hemodialysis floor is responsible for obtaining the signed consents and completing the entire admission packet. A review of the facility policy titled, Advanced Medical Directive/Health Care Proxy, effective date: 01/2021, stated, “... Implementation: A copy of this written policy and procedure will be provided to each staff member, to each new patient or his or her legal representative on admission to the facility and to each existing patient or his or her legal representative. Responsible: The Medical Director, Clinical Nurse Manager and Social Worker will assume ultimate responsibility for assuring compliance with this policy and assuring each patient is advised of his or her legal rights under this policy. ... Procedure: Upon Admission: A. Upon admission to the facility a Social Worker will determine if a patient has previously signed any type of Advance Directive authorized under state law ... If so, the Social Worker will make an effort to obtain a copy for replacement in the patient’s medical record. The Social Worker completes the Advance Directive Assessment Form ...” N.J.A.C. 8:43A-6.3(a)6”

“PR-INFORMED-MAY FILE INT/EXT GRIEVANCE ANON CFR(s): 494.70(a)(16), (17) The patient has the right to- (16) Be informed of his or her right to file internal grievances or external grievances or both without reprisal or denial of services; and (17) Be informed that he or she may file internal or external grievances, personally, anonymously or through a representative of the patient’s choosing. This Standard is not met as evidenced by: 48966 Based on one of one newly admitted patient’s medical record review (Patient (P) 4), staff interview, and review of facility documents, it was determined that the facility failed to ensure that all newly admitted patients are informed of their rights that they can file grievances anonymously. Findings include: On 10/01/24, a review of the P4’s medical record failed to contain documentation of the “Grievance Procedure” and failed to contain the signed “Patient Welcome Packet Consent” to show P4 received the information. During an interview on 10/01/24 at 3:10 PM, S1, Facility Administrator, confirmed the required admission packet was not in the P4’s chart. S1 explained every new admission gets an admission packet and needs to sign the “Patient Welcome Packet Consent” to show that the patient received the information. S1 stated, “for some reason this patient did not have the “Patient Welcome Packet Consent” signed sheet in his/her chart along with the missing consents and documents.” S1 explained that the Registered Nurse on the hemodialysis floor is responsible for obtaining the signed consents and completing the entire admission packet. A review of the facility policy titled, “Patient Grievance Policy,” effective date: 01/2021, stated, “... 2. Internal Grievance Process (should be utilized prior to external) A patient and/or visitor can register a concern or grievance, verbally or by completing a grievance form, without discrimination or reprisal for voicing the grievances. ... 3. External Grievance Process In addition, the patient has the right to file a complaint with the facility or the New jersey State department of health or ESRD [End Stage Renal Disease] Regional Network 2 concerning patient abuse, neglect, and mistreatment ...” N.J.A.C. 8:43A-16.2(a)(7)”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 50912 Based on observation, review of three of seven medical records (Patient (P) 3, P5 and P6), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that post hemodialysis treatment reassessments are completed per facility policy. Findings include: A review of P3’s Treatment Flowsheet dated 09/28/24 at 08:30 AM, indicated in the pre-treatment “Nursing Evaluation” that the patient had plus one bilateral lower leg and ankle edema, with no distortion. The post-treatment “Nursing Evaluation” at 11:51 AM, lacked evidence of a post treatment reassessment of the bilateral lower leg and ankle edema. A review of P5’s Treatment Flow sheet dated 09/25/24 at 10:06 AM, indicated in the pre-treatment “Nursing Evaluation” that the patient had plus one bilateral lower leg and ankle edema, with no distortion. The post-treatment “Nursing Evaluation” at 1:25 PM, lacked evidence of a post treatment re-assessment of the bilateral lower leg and ankle edema. A review of P6’s Treatment Flow Sheet dated 09/30/24 at 10:13 AM, indicated in the pre-treatment “Nursing Evaluation” that the patient had plus 2 bilateral lower leg and ankle edema, plus two distortion 10-15 seconds. The post-treatment “Nursing Evaluation” at 1:25 PM, lacked documented evidence of a post treatment re-assessment of the bilateral lower leg and ankle edema. These findings were confirmed with Staff (10), Registered Nurse, who could not find any post treatment reassessment documentation in the electronic medical records of P3, P5 and P6 on the treatment dates noted. During an interview on 10/01/24 at 11:35 AM, S10 confirmed the post treatment reassessment was not documented on the hemodialysis flowsheets. S10 stated that there should be a post-treatment reassessment if abnormal findings were found pre-treatment. A review of the facility policy titled, “Post Treatment Patient Assessment,” effective 02/2020, stated, “... 1. The patient care staff will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. ... 3. At the end of each dialysis, the patient will be assessed by the RN for response to treatment. 4. Assessment data may include the following: ... Peripheral edema ...” N.J.A.C 8:43A-8.4(b)”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 48966 Based on three of seven medical record reviews (Patient (P) 1, P7, and P5), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that a physician sees each patient and addresses the status and plan for the patient’s renal and comorbid problems as evidenced by monthly progress notes. Findings include: A review of P1’s medical record lacked documented evidence of a physician’s monthly progress note for April, May, June, July, August, and September 2024. A review of P7’s medical record lacked documented evidence of a physician’s monthly progress note for April, May, June, July, August, and September 2024. S4, the Administrative Assistant, was unable to find documented evidence in the computer of a physician monthly progress note for the above-mentioned months. Both P1 and P7’s physician was S17. During an interview on 10/01/24 at 12:15 PM S1, Facility Administrator, stated, “[S17] makes rounds here weekly, I don’t know where he/she is documenting his/her monthly notes.” On 10/02/24 at 1:09 PM, a phone interview was conducted with S12, Medical Director, regarding the missing monthly progress notes. S12 stated the physicians are aware of the requirement to complete notes monthly. S12 explained he/she has talked to the physicians every month but that no formal documentation has been provided to the physicians regarding this matter. S12 did say this has been identified and discussed in their QAPI (Quality Assurance and Performance Improvement) meeting. 50912 A review P5’s medical record lacked documented evidence of monthly physician’s progress notes for May, June, July, August, and September 2024. P5 was admitted in the hospital from 09/18/24-09/25/24. The above was reviewed with S10, Registered Nurse, on 10/01/24 at 10:56 AM. S10 confirmed that no physician notes were found in the patient’s electronic medical record for the above-mentioned months for P5. S10 stated that S17, P5’s physician, has his/her patients go to his/her office for monthly visits or sees his/her patients in the facility. A review of the facility policy titled, “Plan of Care,” effective January 1, 2023, stated, “...The Dialysis Services Facility must ensure that all dialysis patients are seen by a Physician ... providing ESRD [End Stage Renal Disease] care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis ...” N.J.A.C. 8:43A-24.13(d)”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 37656 Based on a review of facility documents and staff interview, it was determined that the facility’s Medical Director failed to participate in the development and periodic review of patient care policies and procedures. Findings include: On 10/3/24, a review of the following facility policy and procedures was conducted and revealed the following: -Infection Control For Dialysis facility; Effective date 4/2019; Revision Dates: ... (blank) -Predialysis Central Venous Catheter Care (CVC); Effective date: 2/2020; Revision Dates: ... (blank) -Central Venous Catheter Care (CVC); Effective date: 2/2020; Revision Dates: ... (blank) -Cannulation of New Arterial Venous (AV) Fistula; Effective date: 2/2020; Revision Dates: ... (blank) - Comprehensive Assessment and Plan of Care; Effective date: 4/2019; Revision Dates: ... (blank) - Hepatitis C Testing and Reporting; Effective date: 7/2016; Revision Dates: ... (blank) - Maintenance of Code Cart; Effective date: 2/2020; Revision Dates: ... (blank) - Prescription Verification and Safety Checks; Effective date: 2/2020; Revision Dates: ... (blank) - Medication Policy; Effective date: 2/2020; Revision Dates: ... (blank) - Central Venous Catheter (CVC) Treatment Initiation; Effective date: 2/2020; Revision Dates: ... (blank) - Pre Hemodialysis Patient Assessment; Effective date: 2/2020; Revision Dates: ... (blank) - Post Treatment Patient Assessment; Effective date: 2/2020; Revision Dates: ... (blank) On 10/03/24 at 1:30 PM, Staff 1, Facility Administrator, stated that the above policies and all the other policies were not available on file in the computer and stated that he/she may have to retype the policies and procedures before it can be revised. S1 stated that he/she will be reviewing all the policies and present it to the governing body during the meeting. Per S1, the policies have not been reviewed by the governing body and they will work on it. Throughout the survey, 09/30/24-10/04/24, multiple requests for policies and procedures were made of Staff (S) 1, Facility Administrator, and S3, Clinic Manager. S1 and S3 could not provide the following policies procedures upon request and could not provide evidence that the policies and procedures were developed: - Policy and Procedure for Internal Cleaning and Disinfection of the Reverse Osmosis Machine lines and Loop. - Policy and Procedure for Priming Dialyzer with Fresenius 2008T Machine - Monthly Progress Notes Policy - Policy and Procedure for mixing of Bicarbonate Solution - Policy and Procedure for Obtaining Microbiological Samples of Water in Dialysis - Policy and Procedure for storage of medications - Policy and Procedure for storage of supplies N.J.A.C 8:43A-24.4(a)”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 39223 Based on observation and staff interviews, it was determined that the facility failed to ensure that the “dummy” drip chamber is not available for use in the hemodialysis treatment room. “Dummy” drip chambers are fluid-filled chambers that are used to bypass the dialysis machine’s air detectors. The presence and availability of “dummy” drip chambers in the hemodialysis patient treatment area is considered an immediate and serious threat to patient health and safety. (V-0403). Findings include: The above findings resulted in an Immediate Jeopardy (IJ) on March 18, 2024 at 10:19 AM. The IJ template was provided to Staff (S) 1, Facility Administrator, on 3/18/24 at 1:57 PM and a removal plan was requested. An IJ Removal plan was provided by the facility on 3/18/24 at 3:58 PM, and was accepted. On 3/19/2024 at 10:39 AM, it was determined that the facility took the following steps to remove the immediacy of the IJ: The Medical director was informed, policy and procedure committee convened, policy developed and accepted by governing body. The facility provided proof of education to all dialysis clinical staff and biomed technician on the following: “Dummy” drip chamber new policy; All staff to ensure “dummy” drip chamber is not on machine prior to removal from maintenance area; staff who were not present on 3/18/24 will be in-serviced prior to start of treatment each day until all staff are in-serviced. A tour of the treatment room was conducted and did not find a “dummy” drip chamber. Staff interviews conducted and confirmed they were educated on the above. It was determined that the IJ removal plan was successfully implemented and the IJ was removed on 3/19/24 at 10:39 AM. Cross Reference: 494.60(b) - Physical Environment: Equipment maintenance - manufacturer’s DFU (Directions for Use)”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 34119 Based on observations, document review, and staff interview, it was determined the facility failed to implement and maintain effective infection control practices. Findings include: 1. The facility failed to ensure staff properly wore their PPE. (Cross Refer 115) 2. The facility failed to ensure all patients receive the Hepatitis B Vaccine according to the schedule for three of three patients who were receiving the Hepatitis B vaccine series (Patient (P) 18, 19, and 20). (Cross Refer V 126) 3. The facility failed to ensure staff receive education regarding emergency plans and procedures, infection prevention and control, universal precautions, and facility policies and procedures. (Cross Refer 132)”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 34119 Based on facility document review and staff interview, it was determined the facility failed to ensure it implements and maintains an effective Quality Assessment and Performance Improvement (QAPI) program. Findings include: 1. The facility failed to perform a mortality review to identify trends in patient deaths and failed to develop an action plan toward improving those outcomes. (Cross Refer V626) 2. The facility failed to provide a written plan of the QAPI program scope, objectives, organization, responsibilities of all participants, and procedures for overseeing the effectiveness of monitoring, assessing and problem-solving activities. (Cross Refer V626) 3. The facility failed to ensure it trends and aggregates data, for its infection control review. (Cross Refer V 637)”

“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: 48966 Based on one (1) of one (1) observation of the initiation of hemodialysis, and review of facility documentation, it was determined the facility failed to ensure staff properly wore their PPE. Finding include: Reference: The Center for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), dated 04/27/01, states, ...Standard precautions are used on all patients and include use of gloves, gown, or mask whenever needed to prevent contact of the health-care worker with blood, secretions, excretions, or contaminated items. In additions to Standard Precautions, more stringent precautions are recommended for hemodialysis units because of the increased potential contamination with blood and pathogenic microorganisms ...Infection Control Practices for hemodialysis Units ...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) ... During an observation at Station #13, on 1/8/24 at 10:27 AM, Staff (S) 15, a Patient Care Technician (PCT), inserted two needles into Patient (P) 14’s right upper arm fistula. S15 was wearing a white protective gown, which was unbuttoned entirely and revealed S15’s clothing underneath. The top of S15’s face shield rested on his/her nose, exposing both his/her eyes to potential blood splash while inserting needles. On 1/8/24 at 1:49 PM, S1 stated that S15 wears the gown open because it does not fit him/her properly and is unable to be closed. S1 stated that the facility does have larger gowns and does not know why S15 is not wearing a bigger gown. A review of the facility policy titled, “Infection Prevention and Control Program,” effective 01/01/23, stated, “... Mitigation of risks associated with patient infections present upon admission ... appropriate use of personal protective equipment, including gowns, gloves, masks and eye protection devices ... adherence to nationally recognized infection prevention and control precautions, such as current CDC guidelines and recommendations, for infection/communicable diseases identified as present in the facility...” Facility Policy titled, “Standard Precautions, effective date 01/01/23, stated, “... Gowns: To be worn during procedures and patient-care activities when contact with blood, body fluids, ... is anticipated to prevent soiling or contamination of clothing and to protect skin. ... Masks, goggles, face shields, ... according to need anticipated by the task performed, to protect the mucous membranes of the eyes, nose and mouth during procedures and patient-care activities that are likely to generate splashes or sprays of blood, ...””

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 34119 Based on medical record review, staff interview, and facility document review, it was determined the facility failed to ensure all patients receive the Hepatitis B Vaccine, according to the schedule, for three of three patients who were receiving the Hepatitis B vaccine series (Patient (P) 18, 19, and 20). Findings include: Reference: Center for Disease Control and Prevention, MMWR Morbidity and Mortality Weekly Report, April 27, 2001/Vol. 50/No. RR-5, stated, “... Prevention and Management of HBV (Hepatitis) Infection ... HBV-Susceptible Patients. Vaccinate all susceptible [non immune] patients against hepatitis B. ...” On 1/8/24, Staff (S) 1, Facility Administrator, provided the Immunization Binder and the following was revealed: A review of the Vaccine Record for P18, indicated P18 received the first dose of Hepatitis B vaccine on 2/6/23 and the second dose on 3/6/23. There is no evidence that P18 received the third dose of the vaccine. The Hepatitis B Management report indicated that on 7/7/23, P18 was tested for Hepatitis B antibodies. The result stated P18 had less than 4, indicating P18 was susceptible to Hepatitis B. A review of the Vaccine Record form for P19 indicated P19 received the first dose of Hepatitis B vaccine on 1/30/23 and the second dose on 3/31/23. There is no evidence that P19 received the third dose of the vaccine. The Hepatitis B Management report indicated that on 7/5/23, P19 was tested for Hepatitis B antibodies and had less than 4, indicating that P19 was susceptible to Hepatitis B. A review of the Vaccine Record form for P20 indicated P20 received the first dose of Hepatitis B vaccine on 2/6/23. There is no evidence that P20 received the second or third dose of the vaccine. The Hepatitis B Management report indicated that on 9/13/23, P20 was tested for Hepatitis B antibodies. The result stated P20 had less than 4, indicating that P20 was susceptible to Hepatitis B. On 1/8/24 at 2:25 PM, S1 stated he/she could not provide any information related to the Hepatitis B vaccination records. S1 stated he/she could not provide documentation of Hepatitis B vaccination records for any patients who were transferred from a recently closed facility. Upon request, S1 could not provide evidence that hepatitis B vaccination surveillance is being performed at the facility. Facility policy titled, Hepatitis B Vaccine Program, effective 01/01/2023, stated, “... Hepatitis B vaccination is recommended for all susceptible chronic hemodialysis patients ... The immunization regimen consists of three (3) doses ... given according to the following schedule: First dose - at elected date Second dose - one (1) month later Third dose - six (6) months after the first dose. ...””

“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: 34119 Based on staff interview and personnel file review, it was determined the facility failed to ensure staff receive education regarding emergency plans and procedures, infection prevention and control, universal precautions, and facility policies and procedures, for four of eight personnel files reviewed. Findings include: The competencies and training for Staff (S) 3, S5, S9, and S11 were requested on 1/5/24. On 1/8/24, S1 stated he/she did not have any competencies or training for S3, S5, S9 and S11. S1 stated he/she did not know where they were.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 34119 Based on staff interview and medical record review, it was determined the facility failed to ensure all patients have a physician’s hemodialysis treatment order that includes the type of treatment and specific requirements of the treatment for five of ten medical records reviewed (Medical Record #1, #5, #8, #10 and #16) Findings include: Reference: The Nurse Practice Act for the State of New Jersey stated: “The practice of nursing as a registered professional nurse is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist.” A review of Medical Records on 1/5/24 revealed the following: Medical Record (MR) #1 contained a physician’s order dated 8/9/23, that lacked identification of the patient’s hemodialysis access site, type, and location, and the arterial and venous needle size to be used for treatment. The hemodialysis treatment sheets dated 12/22/23, 12/27/23, 12/29/23, 12/31/23, and 1/4/24, lacked evidence that the Registered Nurse (RN) contacted the physician to clarify the needle gauge size prior to initializing [starting] hemodialysis. The treatment sheets lacked evidence of the needle size that staff used to access the patient’s access site on the above dates. MR5 contained a Dialysis Prescription dated and signed by S3, a Registered Nurse, on 10/9/2023. This dialysis prescription lacked a physician’s signature authorizing this prescription, the patient’s hemodialysis access type and location, and the arterial and venous needle size to be used for treatment. The medical record lacked evidence that the physician was notified to clarify the dialysis prescription prior to treatment. The hemodialysis treatment sheets dated 12/22/23, 12/24/23, 12/27/23, 12/29/23, and 12/31/23 lacked evidence that the RN contacted the physician to clarify the needle gauge size prior to initializing hemodialysis. The treatment sheets lacked evidence of the needle size that staff used to access the patient’s access site on the above dates. MR 8 contained a physician’s order dated 9/6/2023, that lacked identification of the patient’s hemodialysis access site type and location and the arterial and venous needle size to be used for treatment. The hemodialysis treatment sheets dated 12/22/23, 12/24/23, 12/27/23, 12/31/23, and 1/4/24 lacked evidence that the RN contacted the physician to clarify the needle gauge size prior to initializing hemodialysis. The treatment sheets lacked evidence of the needle size that staff used to access the patient’s access site on the above dates. On 1/8/24 at 1:15 PM, S15, a Patient Care Technician (PCT) was interviewed regarding MR 8’s hemodialysis treatment sheet dated 1/4/24. There was documentation that S15 initiated hemodialysis for P8. S15 was asked what needle size he used to cannulate P8 access. S15 stated he/she used a 15 gauge needle to start the treatment. S15 was asked how he/she determined what needle size to use and S15 stated he/she knew the patient from a different clinic and just used the needle size that was used there. S15 stated he/she does not document on the flowsheet what needle size he/she uses to cannulate patients. S15 stated he/she did not clarify with the RN about what needle size to use. MR10 contained a physician’s order dated 1/4/24, that lacked identification of the patient’s hemodialysis access site type and location and the arterial and venous needle size to be used for treatment. The hemodialysis treatment sheets dated 12/22/23, 12/24/23, 12/27/23, 12/31/23, and 1/3/24 lacked evidence that the RN contacted the physician to clarify the needle gauge size prior to initializing hemodialysis. The treatment sheets lacked evidence of the needle size that staff used to access the patient’s access site on the above dates. Upon request, S1 could not provide a signed authorized dialysis prescription for 12/22/23, 12/24/23, 12/27/23, and 12/31/23. During interview on 1/5/24 at 2:40 PM, S1 confirmed the medical records lacked the needle size on the prescription. S1 stated he/she did not know why it was not on there. S1 could not provide a plan of care for MR1, MR5, MR8, MR10, or MR16 that indicated access needle size. During an interview on 1/8/24 at 9:50 AM, S9, a RN, stated the needle sizes should be there in the dialysis orders. S9 stated that if the needle sizes were missing, he/she would ask the Charge Nurse, but the Charge Nurse/Director of Nursing (DON) left last week. S9 stated he/she would look at the previous treatment flowsheet and confirm with the Doctor. During an interview on 1/8/24 at 11:31 AM S6, an RN, and S10, an RN stated they would call the Doctor for needle sizes if not documented in the hemodialysis orders. They both stated that the Charge Nurse usually enters the dialysis prescription orders. The Charge Nurse/DON was not available for interview because he/she had not shown up for work, nor was he/she available by telephone during the survey. 48966 A review of MR16 was conducted and the following was revealed: A written Physician’s order by the Nephrologist dated 1/3/24 stated, “Okay to use left arm arteriovenous fistula [AVF], use 17G [gauge] needles.” A review of MR16’s hemodialysis treatment sheet, dated 1/4/24, indicated the patient had a central venous catheter. The flowsheet lacked documented evidence that the patient had an AVF. There was no documented needle size. Under the notes section, timed 09:55 AM, it stated that treatment started via arteriovenous graft (AVG). There was no documented evidence that the Registered Nurse assessed the AVG. During an interview on 1/8/24 at 2:38 PM, Staff (S) 8, a Registered Nurse, stated that Patient (P) 16 has a graft and due to his/her experience, he/she used 15 G needles. S8 stated, “The doctor must have written the wrong needle size.” There is no documentation that S8 clarified the needle size with the physician. During an interview on 1/8/24 at 3:04 PM, S17, the Nephrologist, stated that the patient came from New York and, “... I am not sure if the patient has a fistula or a graft. I assume start with 17 G needles.” Facility Policy and Procedure, effective date 1/1/23 titled, “Verbal and Written Orders - General”, stated, “Policy: Orders for patient treatment and medications, ;;; shall be carried out only when given by a qualified physician, ... or other person duly licensed or authorized by the state of New Jersey ... All orders of ... treatment shall be written into the medical record or the patient and signed by the ordering licensed independent practitioner. ... All orders for treatment shall include the type of treatment, specific requirements of the treatment, ...The most recent orders should be used for patient care, treatment, services ... Written Orders: These orders shall be filled when written as stated above and signed by the practitioner. Verbal/telephone Orders: ... Verbal/telephone orders ... shall be received and recorded by the licensed nurse. ... The prescribing practitioner must date, time and authenticate the verbal order within ... 48 hours. ...””

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 37656 Based on a review of four of four months of QAPI (Quality Assurance and Performance Improvement) meeting minutes and interview, it was determined the facility failed to: 1) perform a mortality review to identify trends in patient deaths and failed to develop an action plan toward improving those outcomes; 2) provide a written plan of the QAPI program scope, objectives, organization, responsibilities of all participants, and procedures for overseeing the effectiveness of monitoring, assessing and problem-solving activities. Findings include: A review of the QAPI (Quality Assurance and Performance Improvement) meeting minutes revealed the following: August 30, 2023 for July 2023 data, stated, “... # (number) of Patients Lost Note Deaths by Modality ... E. Death: (HD) [hemodialysis] ... 2 ..” September 29, 2023 for August 2023 data, stated, “... # (number) of Patients Lost Note Deaths by Modality ... E. Death: (HD) [hemodialysis] ... 2 ..” October 27, 2023 for September 2023 data, stated, “... # (number) of Patients Lost Note Deaths by Modality ... E. Death: (HD) [hemodialysis] ... 3 ...” November 30, 2023 for October 2023 data, stated, “... # (number) of Patients Lost Note Deaths by Modality ... E. Death: (HD) [hemodialysis] ... 4 ...” The above QAPI data lacked evidence that a mortality review had been conducted to determine the causes of patient deaths. During an interview on 1/8/2024 at 2:50 PM, Staff #1 (S1), Facility Administrator, stated that the number of deaths were tracked and discussed at the QAPI meetings but he/she could not provide documented evidence of a completed mortality review and Plan of Action. 2. A review of the facility policy and procedure titled, “OPERATIONAL POLICY AND PROCEDURE MANUAL”, effective date 01/2021, states, “Policy: ... Quality Improvement is a basic responsibility of Vistacare Dialysis Center and the Governing Body ... Ensures the implementation and continuance of quality improvement activities ... Reviews all quality assurance activities ... Procedure: A written Quality Improvement Plan which describes the facility’s objectives, responsibilities of it’s participants, ... Scope of the Quality Improvement program ... and Procedures for overseeing the effectiveness of monitoring, assessment and problem solving activities. ...” The above policy and procedure lacked a written plan describing the QAPI program scope, objectives, organization, responsibilities of all participants, and procedures for overseeing the effectiveness of monitoring, assessing and problem-solving activities.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 34119 Based on review of facility Quality Assurance Performance Improvement (QAPI) meeting minutes and program, facility document review, and staff interview, it was determined the facility failed to ensure it trends and aggregates data, for its infection control review. Findings include: A review of the facility QAPI meeting minutes for the months of July, August, September, October, November, and December 2023 were reviewed. On 1/5/24 at 9:30 AM, Staff (S) 1 stated the facility has not conducted any Infection Control Audits since January 2022. S1 stated that the facility does not conduct infection control audits of staff and the facility does not have Infection Control Meetings minutes past February 2022. S1 stated that he/she does not know why the audits have not been done since 2022. S1 stated that S 11, the Director of Nursing, is the day-to-day infection control person and that S 11 is responsible for doing the audits. S1 stated that S 11 has not shown up for work or contacted the facility since 12/29/23. S1 was unable to provide evidence that Infection Control Reports are prepared monthly for the Governing Body. S1 was unable to provide evidence that the lack of Infection Control Audits were discussed in QAPI and that an action plan was developed. On 1/5/24 at 9:30 AM, Staff (S) 1, the Facility Administrator, stated the facility has not had an Infection Control Meeting or conducted infection control audits since January 2022. S1 could not provide evidence of an Infection Control Committee that included the medical director, the infection control professional, administration, or nursing staff. On 1/4/24 at 12:05 PM, Staff (S) 1, the Facility Administrator, stated that the facility’s Certified infection Control Professional (ICC) quit in June 2021. S1 stated the facility does not currently have a ICC and has not had one since June 2021. S1 stated he/she started with the facility in December 2022. S1 stated he/she recently realized the ICC had not been to the facility and that is when he/she found out that the previous ICC had quit in June 2021. S1 stated that they have not been able to find a ICC to take on the facility. On 1/8/24, S1 was unable to provide evidence that the monthly QAPI, discussed patients’ Hepatitis B vaccine status nor develop an action plan for those who needed to complete the series. Facility document titled, “Infection Control Audit Guidance”stated, “... There are 6 [six] audits that will be completed as per the schedule (weekly) ... The results will be reviewed and presented at QAPI [Quality Assurance and Performance Improvement] ... Facility policy titled, “Infection Prevention and Control Program” stated, “... Prepare monthly reports for the Governing Body ...””

“PQ-CHARGE NURSE-12 MO NURSING+3 MO DIALYSIS CFR(s): 494.140(b)(3)(i)-(ii) The charge nurse responsible for each shift must- (i) Be a registered nurse, a licensed practical nurse, or vocational nurse who meets the practice requirements in the State in which he or she is employed; (ii) Have at least 12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis; This Standard is not met as evidenced by: 34119 Based on staff interview and facility document review, it was determined the facility failed to ensure there is a designated Charge Nurse for each shift. Findings include: On the 1/4/24 and 1/5/24, the facility did not have a designated Charge Nurse on the treatment floor. Staff (S) 1, the administrator, who is not a registered nurse, confirmed the DON is usually the charge nurse but he/she had not reported to work since 12/29/23 and has not called out. S1 stated they tried to contact the DON by phone but he/she was not taking calls. S1 stated the alternate DON/Charge Nurse was on vacation. On 1/4/24 at 10:27 AM, on the main treatment floor, the RN’s, S8, and S9, had patient assignments and both stated they were not the charge nurse or the DON. On 1/4/24 at 11:20 AM in the Annex, the RN on the floor stated he/she was not the Charge Nurse nor the DON.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 34119 Based on observation and staff interview, it was determined he facility failed to: 1) ensure that two of two medication refrigerators are monitored daily to ensure all medications are being stored in accordance with manufacturer’s instructions and 2) failed to implement surveillance techniques to identify sources of and minimize transmission of, infections. Findings include: Reference #1: The New Jersey Administrative Code Title 13 Law and Public Safety Chapter 39 State Board of Pharmacy, 13:39-9.23 (a)(4) stated, “... 4) The drugs throughout the facility shall be maintained under adequate storage conditions including proper lighting, ventilation and temperature control ...” Reference #2: The Centers for Disease Control Vaccine Storage and Handling Toolkit, stated, “... An accurate temperature history that reflects actual vaccine temperatures is critical for protecting your vaccines. ... Monitoring Vaccine Temperature and Vaccine Equipment. Monitoring vaccine storage equipment and temperatures are daily responsibilities to ensure the viability of your vaccine supply and the safety of your patients. ...” Reference #3: Aranesp Instructions for Use stated, “Store at 36 (degrees) F (Fahrenheit) to 46 (degrees) F. Do not freeze.” Reference #4: Fluzone Instructions for Use stated, “... 16.2 Storage and Handling Store All Fluzone Quadrivalent presentations refrigerated at ... (35 (degrees to 46 (degrees) F). DO NOT FREEZE. ...” Reference #5: Tubersol Instructions for Use stated, “... Storage Store at ... (35 (degrees to 46 (degrees) F). DO NOT FREEZE. ...” 1. During a tour of the Annex on 1/4/24 at 11:37 AM, in the presence of Staff (S) 10, a Registered Nurse, the medication “Refrigerator Temperature Log” was reviewed for the months of September, October, November and December 2023 and January 2024. It was identified the refrigerator temperature was not monitored for 17 of 30 days in September 2023, 19 of 31 days in October 2023, 18 of 31 days in November 2023, 15 of 30 days in December 2023, and three of four days in January 2024. The Annex medication refrigerator contained 19 boxes of Aranesp and 2 boxes of Daptomycin, both medications require refrigeration. S10 confirmed these medications must be stored in the refrigerator. S10 stated he/she did not know why it was not checked everyday and confirmed there were temperatures missing on the logs. S10 stated it is only checked on Monday, Wednesday, and Friday and did not know how often it should be checked. S10 stated he/she is per diem and not in charge and did not know what the policy was for how often the refrigerator temperatures should be checked. During a tour of the Main Treatment floor on 1/4/24 at 12:55 PM, in the presence of S1, Facility Administrator, the medication “Refrigerator Temperature Log” was reviewed for the months of October, November, December 2023 and January 2024. It was identified that the refrigerator temperature was not monitored 10 of 31 days in October 2023, 10 of 31 days in November 2023, 21 of 31 days in December 2023, and three of four days for January 2024. The Main Treatment floor medication refrigerator contained two boxes of Fluzone, 11 boxes of Daptomycin, multiple boxes of Activase and Aranesp, Tubersol. S1 stated staff only check the refrigerator temperatures in the morning and in the afternoon on Monday, Wednesday, and Friday. S1 confirmed the facility provides hemodialysis treatments six days a week. S1 also confirmed staff do not check the medication refrigerators every day to ensure the temperature is maintained at all times. Upon request on 1/4/24 at 1:10 PM, S1 could not provide a policy and procedure for maintaining the medication refrigerator temperatures. Upon request on 1/8/24 at 2:13 PM, S1 was unable to provide the facility medication administration policy. S1 stated the facility did not have a medication administration policy. 2. On 1/5/24 at 9:30 AM, Staff (S) 1 stated the facility has not conducted any Infection Control Audits since January 2022. S1 also stated the facility does not conduct infection control audits of staff, and the facility does not have Infection Control Meetings minutes past February 2022. S1 stated he/she does not know why the audits have not been done since 2022. S1 stated that S11, the Director of Nursing, is the day-to-day infection control person and that S11 is responsible for doing the audits. S1 stated that S11 has not shown up for work or contacted the facility since 12/29/23. S1 was unable to provide evidence that Infection Control Reports are prepared monthly for the Governing Body. Facility document titled, “Infection Control Audit Guidance”stated, “... There are 6 [six] audits that will be completed as per the schedule (weekly) ... The results will be reviewed and presented at QAPI [Quality Assurance and Performance Improvement] ... Facility policy titled, “Infection Prevention and Control Program” stated, “... Prepare monthly reports for the Governing Body ...””