Fmc Neptune

“CFC-INFECTION CONTROL CFR(s): 494.30 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 that: 1) staff perform proper handwashing (V-113); 2) visible blood is cleaned and disinfected from all surfaces of the dialysis station after patient use (V-122); and 3) hemostat clamps and pressure clamps are cleaned and disinfected after patient use in accordance with facility policy (V-122). This failure resulted in an Immediate Jeopardy (IJ), posing serious risk of harm to the patients. Findings include: On 02/07/25 at 2:26 PM, an IJ was identified for the facility’s failure to ensure that visible blood was cleaned and disinfected from all surfaces of the dialysis station after patient use. On 02/07/25 at 3:17 PM, the IJ template was presented to the Group Facility Administrator, and a Removal Plan was requested. On 02/10/24 at 10:35 AM, an acceptable Removal Plan was received. The facility implemented the following to address the IJ: inspection of all patient chairs to ensure all surfaces were free of blood, education to all clinical staff on cleaning and disinfection of the station and cleaning blood spills, daily audits of cleaning and disinfection of the station, and daily governing body meetings to review the progress of the plan. The IJ was removed on 02/10/25 at 11:51 AM, after the State Survey Agency verified the full implementation of the removal plan, and Condition Level non-compliance remains (V-122). Cross Reference: 494.30(a)(1) - Ic (Infection control)-Wear gloves/Hand Hygiene 494.30(a)(4)(ii) - Disinfects surfaces/equip (equipment)/written protocols”

“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: 37656 Based on one of two observations of decannulation of a venous access, staff interview, and review of facility documents, it was determined that the facility failed to ensure that staff perform proper handwashing in accordance with facility policy. Findings include: On 02/07/25 at 10:25 AM in Station 23, Staff (S) 11, Registered Nurse, with gloves on, held the patient’s bleeding AVF (arteriovenous fistula/AVG (arterio-venous graft) site. After holding the site, S11 removed his/her gloves and washed his/her hands in the clean sink across from Station 21. S11 applied soap to his/her hands and rubbed his/her hands together under running water. This did not allow the soap to be distributed throughout all surfaces of the hands before allowing water to rinse the soap off. During an interview at 10:30 AM, S11 stated that their policy is to wash hands for 20 seconds but he/she was in a rush. Facility policy titled, “Hand Hygiene,” published 11/06/23, stated, “... Procedure for Washing Hands with Soap and Water ... 3. Wet hands with running water. Water is needed to lather soap. 4. Apply soap to hands using amount recommended by the product manufacturer (frequently 3 to 5 ml [milliliters]). Soap will aid in breaking up and lifting contaminants away from the skin. 5. Rub hands together vigorously. Cover all surfaces of the hands and fingers. Friction helps to remove skin surface contaminants. 6. Rinse hands with running water and dry thoroughly with a disposable towel. ... 7. ... Note: Duration of the entire procedure: 40-60 seconds ...””

“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: 49828 Based on one of two observations of the cleaning and disinfection of the dialysis stations, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that: 1) visible blood was cleaned and disinfected from all surfaces of the dialysis station after patient use. The presence of blood on the hemodialysis treatment chair is considered an immediate and serious threat to patient health and safety; and 2) hemostat clamps and pressure clamps are cleaned and disinfected after patient use in accordance with facility policy. Findings include: 1. On 02/07/25 at 9:57 AM in Station 2, Staff (S) 3, a Patient Care Technician (PCT) removed a fistula needle from Patient (P) 1’s left arm arteriovenous fistula (AVF). While holding pressure with gauze to the AVF, S3 placed a plastic pressure clamp on the removal site. P1’s access immediately bled onto the pressure clamp, down the inside of his/her arm, the inside of the hemodialysis treatment chair, and dripped onto the floor. S3 placed a new gauze onto P1’s AVF and returned the pressure clamp onto P1’s AVF. P1’s access bled again, requiring S3 to hold pressure again. S4, a Registered Nurse, used three 1:100 bleach-soaked cloths (one part bleach to 100 parts water) to clean one baseball sized and two other smaller sized blood spills from the floor under the left arm of the treatment chair. After stabilizing, P1 was discharged at 10:32 AM. During an interview at 10:07 AM, S4 stated that he/she used 1:100 bleach solution because he/she felt the spill was under 10 ml (milliliters). S4 continued, that if the spill was over 10 ml, he/she would use 1:10 bleach solution (one part bleach to 10 parts water). At 10:46 AM in Station 2, S3 cleaned the hemodialysis machine and the treatment chair. S3 opened the left arm of the chair which revealed visible blood on a large portion of the inside left arm panel’s surface and on the left side of the seat. S3 used a 1:100 bleach-soaked cloth and cleaned the area. S3 used the same cloth and moved to another area of blood that had dripped onto the floor. S3 disposed of the cloth in a biohazard bin and removed his/her gloves and performed hand hygiene. S3 donned new gloves, acquired a new 1:100 bleach-soaked cloth, and cleaned over the area again. S3 left the sides of the chair open to air dry while he/she completed cleaning the rest of the treatment chair and the station. While the sides of the chair were open, wet appearing blood was visible on the left side of the seat of the chair. At 10:59 AM, S3 returned to the station, closed the sides of the treatment chair, and began to setup the hemodialysis machine for the next patient. At 11:00 AM, this surveyor requested that S4 open the left panel of the chair. Upon opening the left arm of the chair, S4 confirmed that visible blood was present on the left side of the seat and on the back left wheel. S4 and S3 acquired 1:100 bleach-soaked cloths and cleaned the blood present on left side of the seat, and back left wheel. 2. On 02/07/25 at 10:46 AM in Station 2, S3 removed a vascular clamp used on P1’s left arm, which had visible blood present on it, and placed it into the bucket of 1:100 bleach used for soaking clamps. During an interview at 11:02 AM, S3 confirmed that he/she placed a clamp with visible blood on it into the soaking bucket. S3 stated, “from what I have been told” clamps with visible blood on them are placed into the soaking bucket. During an interview at 11:08 AM, S1, the Charge Nurse, stated that clamps that have visible blood should be cleaned with a 1:100 bleach soaked cloth prior to being placed into the soaking bucket with the other clamps in order to “not get the rest of the clamps bloody.” 39223 On 02/07/25 starting at 10:20 AM, a tour of the Hemodialysis Treatment Room was conducted and the following was revealed: A 1:100 bleach solution container, located on the central nurse station countertop, next to a dirty sink, contained 20 plastic hemostat clamps and five plastic pressure clamps soaking in the solution. Four hemostat clamps soaking in the liquid were in a closed position. This prevented the bleach solution from making contact with and disinfecting all surfaces of the closed hemostat clamps. During an interview at 10:44 AM, S1, the Charge Nurse, stated that the hemostat clamps should be soaking in an open position. S1 then proceeded to open the hemostat clamps and return them into the bleach solution to soak. Facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 09/05/23 stated, “Purpose, The purpose of this policy is to provide guidelines to prevent the spread of infectious disease ... General Cleaning, The dialysis station could become contaminated with blood and other body fluids during treatment. ... Work Surface Cleaning and Disinfection with Visible Blood > [greater than] 10ml and Other Potentially Infectious Material using Bleach Solutions, Use 1:10 bleach solution to clean surfaces with visible blood. Note: If needed, staff may use an absorbent cloth to clean up excess blood prior to cleaning and disinfecting blood spill. After cleaning up all the visible blood, use a new cloth wetted with 1:100 bleach solution for a second cleaning of the surface. Make the surface glisteningly wet and let air dry unless otherwise specified by the manufacturer. Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible. ... Cleaning Clamps Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with 1:100 bleach solution per the Mixing bleach policy. Make sure the items are completely submerged, unclamped, and in open position when placed in the solution. ...””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 49828 Based on observation, medical record review, review of facility documents, and staff interview, it was determined that the facility failed ensure that interventions to mitigate the risk of the spread of bed bug infestations are implemented and documented in accordance with facility policy for one of one patient identified with bed bugs (Patient (P) 4). Findings include: On 02/07/25 at 11:30 AM, P4 entered the hemodialysis treatment floor and was escorted by staff directly to Station 15, located directly to the right when entering the treatment floor. The curtains were drawn closed and P4 changed into a facility provided disposable paper gown and P4’s personal clothing/belongings were placed and kept inside blue heater bags for the duration of his/her dialysis treatment. During an interview at 11:15 AM, Staff (S) 7, a Patient Care Technician (PCT), identified that P4 was on precautions for bed bugs. A review of Medical Record (MR) 4 revealed the following: A Social Work Progress note dated 08/12/24, stated, “SW [Social worker] contacted pt’s [patient’s] sister via phone. Discussed pt. arrive at clinic with BB [bed bug] on him/her. ...”. Further review of the hemodialysis treatment sheets dated 08/12/24, 08/14/24, and 08/16/24, lacked documented evidence that the following precautions outlined by the “Bed Bug Control Policy” were implemented for each hemodialysis treatment reviewed: the patient wore a second set of clothes previously treated in a heater bag, all current belongings were placed into heater bag for duration of treatment, the room patient changed in was examined and used a hand held steamer to kill any bugs that may have fallen off the patient while changing, and when the treatment was completed the staff used a hand held steamer on the chair. During an interview on 02/10/25 at 2:24 PM, S18, Director of Operations, confirmed the staff are not documenting the interventions for the bed bugs. S18 stated the interventions should be documented every treatment. During an interview on 02/10/25 at 2:35 PM, S19, the Facility Administrator stated, “I think pest control was called immediately but I cannot remember.” A review of the facility provided “Integrated Pest Management Service Report,” revealed two “Routine” services were provided on: 12/02/24, three months and 21 days after the bed bugs were identified, and 1/6/25. Both reports did not include an inspection of the hemodialysis treatment floor or patient waiting area. During an interview on 02/07/25 at 2:07 PM, S7, the Regional Operations Manager, stated he/she was unable to provide documented evidence that the facility was serviced for a Bed Bug Inspection during August, September, October, and November 2024. Facility policy titled, “Bed Bug Control Policy,” updated December 2022, stated,”... Policy, When a patient is identified with having bed bugs, the clinic must take immediate actions to mitigate the risks of exposure to the clinic, other patients and staff ... Following the procedures outlined below, clinics should be able to contain the issue and work with the infested patient to treat the root cause of the problem ... Procedure ... Notify your pest control provider of a bed bug positive patient so that they can immediately implement monitoring techniques such as the use of bed bug monitoring devices ... When the patient arrives, ask that they immediately enter the bathroom and change into a 2nd set of clothes that was previously treated in the heater bag. They should then place all personal belongings and clothes (except for items that may be damaged by extreme heat. I.e. Cell Phones) in the heater bag for treatment during the dialysis treatment. The extreme heat will kill any bugs in the bag. After the patient has changed, ask the clinic staff examine the bathroom for the presence of bed bugs and use the hand held steamer to kill any that may have fallen off the patient while changing. If possible, place the patient in a dialysis chair away from other patients to mitigate the risk of transferring bed bugs to others. When the dialysis treatment is complete, use the hand held steamer to steam the chair that the patient sat in. This should kill any bugs or eggs that may be present. Have the patient remove their personal belongings from the treatment bag, but leave the original set of clothes, as they will wear them for their next treatment (the patient will switch into pre treated clothes at each treatment). Clothes can either remain in the treatment bag or be stored in an airtight container between treatments. Continue process until root cause of the problem has been addresses and issue has been eliminated. Notify Pest control provide of resolved issue so that they can discontinue bed bug monitoring techniques. ... Documentation, Clinic staff should document all interventions taken and response to interventions in the Medical Records ...””

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 39228 Based on observation of one of four handwashing sinks, review of facility policy, and staff interview, it was determined that the facility failed to ensure that the supply of paper towels available at each handwashing sink is protected from potential contamination. Findings include: On 6/12/24 at 10:25 AM, during a tour of the treatment floor, a handwashing sink located across from Station #15 had a supply of paper towels in a wall mounted dispenser that had been removed from the wall. The dispenser was positioned on the countertop directly next to the sink. Upon interview at 11:17 AM, Staff (S)7, the Charge Nurse, stated that the paper towel holder fell down a couple of months ago and had not been remounted back onto the wall yet. Review of facility policy titled, “Hand Hygiene,” published 11/6/2023, stated, “... Sink Policy ... Soap and a supply of paper towels protected from contamination must be available at each sink. ...” N.J.A.C. 8:43A-24.4(b)”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48966 Based on two of two observations of the dirty sink area, staff interviews, and review of facility policy, it was determined that the facility failed to clearly designate clean areas from dirty areas in order to avoid possible cross contamination. Findings include: During a tour of the hemodialysis treatment area on 6/12/24 starting at 9:43 AM, the following was observed: The dirty sink across from Station #17 contained two large rectangular containers on the countertop labeled with 1:100 bleach solution and clamps that were submerged in the bleach solution. Directly adjacent to the dirty sink was a two tiered cart that had a large amount of white residue, black residue, and dust. The cart was positioned close to the dirty sink and items on the cart could become potentially contaminated by liquid splashing from the sink and/or the bleach solution. The cart contained the following supplies: 1. On the top shelf of the cart were two lid-less clear rectangular containers which contained blue and white clamps while a yellow lid-less container held acid wands. 2. On the second shelf was six spray bottles and on the third shelf was an opened bottle of vinegar and bleach. During an interview at 10:01 AM, Staff (S) 10, a Patient Care Technician, confirmed the two tiered cart, along with the supplies, was considered clean. During an interview at 10:50 AM, S7, the Charge Nurse, confirmed the cart next to the dirty sink was clean along with the supplies stored on it. S7 moved the cart away from the dirty and sink and placed lids on the three containers on the top shelf. 39228 On 6/12/24 at 10:25 AM, during tour of the treatment floor, a sink located across from Station #18, had a pHoenix Meter (a device used to check the conductivity and pH of dialysate solution) and several packages of unopened clean supplies (caps) on the countertop. There was also a table directly next to the clean supplies on the sink that contained several blood sample tubes. The sink was not labeled as a clean or dirty sink. Upon interview with S6, a Patient Care Technician, on whether the sink was a clean or dirty sink, S6 stated that the sink was a clean sink but that the staff did not wash their hands at that sink. At 11:08 AM, an interview was conducted with S7, the Charge Nurse. S7 stated that the sink was a dirty sink and the clean supplies located on the countertop should not be stored there and directly next to blood samples. At 11:22 AM, an interview was conducted with S5, the Area Technical Operations Manager, who explained that the sink is a dirty sink because the pHoenix Meter is stored there and that the bleach solution that gets expelled post disinfection had to be drained into a dirty sink. A review of facility policy and procedure titled, “Dialysis Precautions,” published 1/4/2012, stated, “... Clean Versus Dirty Areas ... Clean area: An area designated for clean and unused equipment, supplies and medication. ... Dirty area: An area where this is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. ... Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored. ...” 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: 39228 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: On 6/12/24 at 12:06 PM, Staff (S)7, Charge Nurse, and Staff (S)10, a Patient Care Technician, performed a test for total chlorine levels in the Water Treatment Room. S7 obtained a sample cup of water and after filling and dumping the cup with water three times, dipped a RPC E-Z Chek Sensitive Total Chlorine Test Strip in the sample. S7 then removed the strip from the water and together with S10, immediately compared the test strip color to the color chart to determine the level of chlorine. S7 and S10 did not wait 20 seconds to compare the strip to the color chart. This was not in accordance with manufacturer’s instructions for use, which 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. ...” During an interview immediately after the observation, S7 and S10 stated that they do not need to wait to read the test results. S4, Biomedical Technician and S5, Area Technical Operations Manager, were made aware of the findings and indicated that they would re-educate the staff. A review of facility policy titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strips Procedure,” published 4/5/2021, stated, “... Procedure ... Step 4... Remove the strip and shake once, briskly, to remove excess water. Step 5... Wait 20 seconds for the test strip color to develop. ... Step 6... After the 20 second wait period, immediately compare the strip color to the K100-0118 color chart to determine the Total Chlorine level in the sample. ...” N.J.A.C. 8:43A-24.4(a)”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 49828 Based on five of five observations of four ‘clean sink’ areas, observations of ceiling tiles, and staff interviews, it was determined that the facility failed to ensure that a safe and clean treatment environment is provided for patients, staff, and the public. Findings include: On 6/12/24 at 10:44 AM, a tour of the dialysis treatment area was conducted, and the following observations were made: The sink across from Station #15 labeled, “Clean Sink” had delamination (peeling of the laminate) on both cabinet doors located directly underneath the sink, exposing the wood framing beneath it and rendering the surface uncleanable. The door hinges inside the cabinet were stained reddish- brown, and there was brown and black substance stains on the bottom of the cabinet. On the top counter of the sink, there was a glass splash guard present. Between the splash guard and back portion of the sink surface there was a dark green, and black substance that was not reachable for cleaning without removing the glass splash guard. The sink across from Station #8 labeled, “Clean Sink” had delamination on both cabinet doors located directly underneath the sink exposing the wood framing beneath it. Within the cabinet was a laminated sign that stated, “DO NOT PUT ANYTHING HERE UNDER SINK.” Next to this sign was a bottle labeled, “Pure Bright Germicidal Ultra Bleach.” There was also an area of yellowish-brown stains on the bottom of the cabinet, and reddish- brown stained cabinet door hinges. On the top counter of the sink there is a glass splash guard present. Between the splash guard and back portion of the sink surface there was a dark green, and black substance that was not reachable for cleaning without removing the glass splash guard. The sink across from Station #2 labeled, “Clean Sink” had delamination on both cabinet doors located directly underneath the sink exposing the wood framing beneath it. Within the cabinet, below the sink, there were brown and black substance stains. On the top counter of the sink there is a glass splash guard present. Between the splash guard and back portion of the sink surface there was a dark green, and black substance that was not reachable for cleaning without removing the glass splash guard. The sink across from Station #21 labeled, “Clean Sink” had delamination on both cabinet doors. The right side had clear tape securing the laminate in place. Within the cabinet there were brown and black substance stains. On the top counter of the sink there is a glass splash guard present. Between the splash guard and back portion of the sink surface there was a dark green, and black substance that was not reachable for cleaning without removing the glass splash guard. 37656 On 6/12/24 at 10:30 AM, during tour of the treatment room, the ceiling light fixture and the three white square ceiling tiles surrounding the fixture, across from Station #12 and the Nurse’s station, contained brown stains. Upon interview at the time of discovery, Staff (S) 6, Patient Care Technician, stated that he/she did not noticed it before until this surveyor showed him/her. N.J.A.C. 8:43A-17.4(a)(13)(15)”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 39228 Based on observation and staff interview, it was determined the facility failed to ensure that a means to flush the eyes and/or body are available within the immediate work area in the event that it is needed. Findings include: During a facility tour conducted on 6/12/24 starting at 10:00 AM, in the presence of Staff (S)4, Biomedical Technician and S5, the Area Technical Operations Manager (ATOM), there was no eyewash/drench shower located within the Water Treatment Room or the Store Room where acid drums are stored and transferred into distribution tanks. There was an eyewash/drench shower located in Room 129 (Storage Room). However, Room 129 could only be accessed by going through two (2) doors (one door to exit either the Water Treatment Room or the Store Room) and another door to enter the storage room containing the eyewash/drench shower. S5 confirmed the above finding. Reference: OSHA [The Occupational Safety and Health Administration] 29 CFR [Code of Federal Regulations] 1910.151(c) states: “Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick, drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use.””

“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: 48966 Based on staff interview, review of one of four medical records (Patient [P] 3) and a review of facility policy, it was determined that the facility failed to ensure that post (following) hemodialysis treatment assessments are completed on all patients. Findings include: A review of P3’s hemodialysis flowsheets revealed the following: On 5/24/24 at 7:43 AM, a pre-treatment (before treatment) “Nursing Evaluation” stated, “edema ankle and lower leg- bilateral [affecting both sides], severity +1: 2 mm (millimeter) or less, disappears rapidly and decreased bilateral breath sounds.” At 12:41 PM, the nursing post- treatment evaluation had no re-assessment or documentation of edema or lung sounds. On 5/29/24 at 7:20 AM, a pre-treatment “Nursing Evaluation”stated, “edema ankle and lower leg- bilateral, severity +1: 2 mm or less, disappears rapidly and decreased bilateral breath sounds.” At 12:23 PM, the nursing post- treatment evaluation had no re-assessment or documentation of edema or lung sounds. On 5/31/24 at 7:28 AM, a pre-treatment “Nursing Evaluation” stated, “edema ankle -bilateral, severity +1: 2 mm or less, disappears rapidly and decreased bilateral breath sounds.” At 12:16 PM, the nursing post- treatment evaluation had no re-assessment or documentation of edema or lung sounds. On 6/3/24 at 7:45 AM, a pre-treatment “Nursing Evaluation” stated,”edema ankle and lower leg-severity +1: 2 mm or less, disappears rapidly and decreased bilateral breath sounds.” At 11:30 AM, the nursing post- treatment evaluation had no re-assessment or documentation of edema or lung sounds. On 6/7/24 at 7:43 AM, a pre-treatment “Nursing Evaluation” stated, “edema ankle and lower leg-severity +1: 2 mm or less, disappears rapidly and decreased bilateral breath sounds.” At 11:25 AM, the nursing post- treatment evaluation had no re-assessment or documentation of edema or lung sounds. On 6/10/24 at 7:43 AM, a pre-treatment “Nursing Evaluation” stated, “edema ankle and lower leg- bilateral, severity +1: 2 mm or less, disappears rapidly and decreased breath sounds and wheezing on left lung.” At 12:25 PM, the nursing post- treatment evaluation had no re-assessment or documentation of edema or lung sounds. On 6/12/24 at 7:27 AM, a pre-treatment “Nursing Evaluation” stated, “edema ankle and lower leg- bilateral, severity +1: 2 mm or less, disappears rapidly and decreased bilateral breath sounds.” At 2:07 PM, the nursing post- treatment evaluation had no re-assessment or documentation of edema or lung sounds. During an interview on 6/12/24 at 3:01 PM, Staff (S) 1, the Clinic Manager, stated, “I am not sure if a post reassessment comes up in the computer for the Registered Nurse to reassess edema.” S1 stated, “it could take more than one treatment to see if edema has improved.” S1 confirmed the Registered Nurse should reassess if abnormal findings were found pre-treatment. A review of facility policy and procedure titled, “Patient Assessment and Monitoring,” published 5/1/23, stated, “... Post-Treatment Follow the steps below for obtaining post-treatment assessment data: ... 1 ... Lungs sounds, Edema ... The registered nurse will ... assess/reassess post treatment as indicated. ... 2 Document findings in the patient’s record. ...” N.J.A.C. 8:43A-24.4(a)”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 48966 Based on a review of two of four medical records (MR 5 and MR 9), staff interview, and review of facility policy, it was determined that the facility failed to ensure that the patient reviewed and signed the Plan of Care (POC) after it was developed by the Interdisciplinary Team (IDT). Findings include: A review of MR 5 and MR 9 revealed the following: A review of a Hemodialysis Patient (P) 5’s initial Plan of Care dated, 5/30/24 indicated it was signed by the Social Worker (SW), Registered Dietician (RD), Registered Nurse (RN) and the Physician, but was not signed by the patient. During an interview on 6/13/24 at 2:55 PM, S1, the Facility Manager, confirmed he/she looked for the signed Plan of care for P5 but was unable to find it. A review of P 9’s stable Plan of Care, dated 2/29/24, indicated it was signed by the SW, RD, RN, and the Physician, but was not signed by the patient. During an interview on 6/13/24 at 12:26 PM, Staff (S) 2, the Home Clinical Manager, confirmed he/she was unable to find the signed Plan of Care for P9. Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 07/03/23 indicated, “The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of the patient or patient’s designee .... The Comprehensive Assessment and Plan of Care must be completed electronically in the patient’s medical record. The Plan of Care must be signed at the time of the interdisciplinary team meeting for those attending in person or if attending remotely within 30 days of the interdisciplinary team meeting.” N.J.A.C. 8:43A-24.4(a)”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 37656 Based on observations, staff interviews, and review of facility documents, it was determined the facility medical director failed to: 1) implement facility policy to ensure that open acid jugs are properly labeled and stored for one of one opened acid jug observed; 2) ensure that physicians are notified of the early termination of a hemodialysis treatment in two of three medical records (Patient [P] 6 and P13) reviewed for shortened treatments; and 3) ensure that all medications, needles, and syringes are stored in locked areas for three of three medication and syringes storage carts observed. Findings include: 1. On 6/12/24 at 11:05 AM, during tour of the dialysis treatment floor, an opened jug, approximately two third (2/3) full of Naturalyte 2.0 K (Potassium), 2.0 Ca (Calcium) acid solution, was on the chaise wall of Station #25, the Isolation Room. The container was not labeled with a date of opening and was available for use. Upon interview at the time of discovery, Staff (S) 11, a Patient Care Technician, stated that he/she did not know why it was there and did not know when it was opened. S11 stated, “we do not reuse acid jugs.” A review of the facility policy titled, “Acid Concentrate Storage and Handling,” published 7/3/23, stated, “... Concentrate Container Labeling ... 1 gallon container: If unused acid will be stored for further use, record on the container the date and time it was opened and the initials of the staff member that opened the container. ... Acid Concentrate Gallon Container ... Prior to treatment: ... Label the acid per policy. ...” 39228 2. A review of P6’s medical record revealed the following: The “Orders Summary Report” stated, “... Hemodialysis In Ctr [Center], MonWedFri [Monday, Wednesday, Friday], 4 hrs [hours] 0 min [minute] ... Start Date 05/22/2024 ...” On 5/22/24, the “Treatment Sheet” indicated that P6’s initiation of hemodialysis began at 12:15 PM and that treatment was discontinued at 3:33 PM, 42 minutes earlier than the prescribed treatment time. The Multidisciplinary Notes section of the Treatment Sheet stated, “Late entry, patient requested to leave 41 minutes early ...” On 5/31/24, the “Treatment Sheet” indicated that P6’s initiation of hemodialysis began at 12:08 PM and that treatment was discontinued at 3:46 PM, 34 minutes earlier than the prescribed treatment time. The Multidisciplinary Notes section of the Treatment Sheet stated, “Late entry, patient requested to come off 21 minutes early ...” The medical record did not contain evidence that the physician was notified of the shortened treatments. On 6/13/24, review of P13’s medical record revealed the following: The “Orders Summary Report” stated, “... Hemodialysis In Ctr, MonWedFri, 3 hrs 30 min ... Start Date 03/04/2024 ...” On 6/5/24, the “Treatment Sheet” indicated that P13’s initiation of hemodialysis began at 5:01 PM and that treatment was discontinued at 8:06 PM, 25 minutes earlier than the prescribed treatment time. The Multidisciplinary Notes section of the Treatment Sheet stated, “Late entry, patient requested to come off 28 minutes early ...” The medical record did not contain evidence that the physician was notified of the shortened treatment. On 6/13/24 at 3:06 PM, the above findings were confirmed with S1, the Clinic Manager. Review of facility policy and procedure titled, “Early Termination or Arriving Late for Treatment,” published 11/7/22, stated, “... Early Termination ... If a patient requests to leave treatment early: ... The RN is responsible to notify the physician ... Documentation ... any notification or discussion with the physician, must be documented in the patient’s medical record. ...” 49828 3. On 6/12/24 at 9:45 AM, a tour of the dialysis treatment floor was conducted and revealed the medication storage carts across from Station #3, Station #12, and Station #19 were unsecured. There were several types of injectable and oral medications present in the first drawer of each cart. The second and third drawers contained needles and syringes. At 9:47 AM, S11, Licensed Practical Nurse (LPN), stated he/she uses a lever on the right side to open the cart. S11 demonstrated opening the cart by turning the lever down located on the right side, which allows the drawers on the cart to open. At the time of the observation, all the above cart’s levers were down allowing for immediate opening of the drawers. At 9:50 AM, S7, Charge Registered Nurse, stated that he/she uses a code to access the medication storage cart. S7 attempted to demonstrate this at the medication storage cart across from Station #3. The demonstration revealed that control panel was not lighting up nor responding to touch and the cart was unlocked. S7 stated that he/she was unaware that the cart was unlocked, and the control panel was not working. At 11:36 AM, S12, Registered Nurse, stated, “there is no code used for the medication cart.” S12 demonstrated that he/she pulls the lever on the right side of the cart to open the drawers. Facility Policy titled, “Medication Preparation and Administration” revised 2/6/23, stated the following: “... Securement: The following steps must be taken for the securement: All medications will be kept in a locked cabinet except when in use...There are states that may require securement of syringes and or needles in addition to medications (example: New Jersey). Ensure syringes and or needles are secure if per state requirements...” N.J.A.C. 8:43A-9.3(b)(6) N.J.A.C. 8:43A-9.5(a) N.J.A.C. 8:43A-24.4(a)”