Fmc Silver

“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: 39228 Based on observation, staff interview, and review of facility documents, it was determined the facility failed to ensure that one of one Emergency Code Cart is secure and contains all necessary equipment in the event of an emergency. Findings include: On 12/18/24 at 11:20 AM, Staff (S) 9, the Charge Nurse, stated that the facility had one Emergency Code Cart located in the Hemodialysis Treatment Area. S9 provided documentation of an itemized checklist of the Emergency Code Cart’s contents and stated that the cart was last checked on 11/14/24. Initial review of the cart revealed that the top drawer, which contained emergency medications (calcium chloride, sodium bicarbonate, naloxone, diphenhydramine, epinephrine, solumedrol, and oral glucose), was unlocked. Upon further review, the bottom drawer of the cart, which contained emergency supplies and equipment, was also unlocked. The remaining three drawers of the cart were locked. This finding was confirmed with S12, the Facility Administrator, at the time of discovery. Review of the contents of the cart revealed that one O2 (oxygen) face mask, indicated on the checklist, was not present. During an interview at 11:55 AM, S9 confirmed that the O2 face mask was missing from the cart and stated that he/she would replace it. Facility policy titled, “Emergency Medications, Equipment and Supplies,” published 05/01/2023, stated, “... Policy: ... Emergency Cart ... The emergency cart must be: Locked when not in use, Checked monthly or after use for contents ... of all equipment. ...” N.J.A.C. 8:43A-15.1(d)”

“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: 39228 51990 Based on one of two observations of the discontinuation of dialysis via an AVG (arterio-venous graft, an access used for hemodialysis), staff interview and a review of facility documents, it was determined that the facility failed to ensure that patients perform hand hygiene after applying pressure to their decannulated (the process of removing a cannula) access sites. Findings include: On 12/18/24 at 10:47 AM, in Station 18, Patient (P) 8, with ungloved hands, removed his/her needle from their AVG access site, and then applied pressure to the site with a piece of gauze. At 11:01 AM, P8, without first performing hand hygiene, picked up a blue pad that was sitting on the recliner chair and then exited Station 18. P8 then walked to the patient scale area where Staff (S) 9, the Charge Nurse, met him/her to be weighed. P8 used the blue pad from Station 18 as a barrier between his/her hand and the patient scale while he/she pressed a button. This could cause possible contamination of the patient scale. P8 then walked back to Station 18, assisted by S9. Once in the station, P8 gathered his/her belongings and exited the treatment floor. P8 did not perform hand hygiene prior to exiting the treatment area. During interview with S9 at 11:10 AM, he/she stated patients should wash their hands after applying pressure to stop bleeding of AVG needle sites and before leaving the treatment area. Facility policy titled, “Hand Hygiene” published 11/06/23, stated, “... Responsibility All staff, patients, ... must follow the same requirements for hand hygiene. Policy ... Hands will be ... decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water When ... leaving the treatment area ... after contact with ... non intact skin, and wound dressings if hands are not visibly soiled, after contact with inanimate objects near the patient ... after contact with other objects within the patient station or treatment space ...” N.J.A.C 8:43A-24.8(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: 39228 Based on three of three observations of clean/dirty work spaces/areas, staff interviews, and review of facility policy, it was determined that the facility failed to clearly designate clean areas from dirty areas to avoid possible cross contamination. Findings include: On 12/18/24 during a tour of the Hemodialysis Treatment Floor, the following was revealed: At 10:32 AM, a portable three-tiered clean supply cart, located outside of and against the window area of Station 18, had clean supplies on all three shelves. This cart directly touched a red biohazard container. Upon discovery, Staff (S) 9, the Charge Nurse, stated the clean supply cart should not touch the biohazard container and stated, “The biohazard container is usually kept in Station 18, but we moved it out of there because Patient (P) 8 (the patient dialyzing in Station 18 at the time of the finding) did not like it in there.” During an interview at 2:29 PM, S9 stated that the clean supply cart, located in Station 18, had two partially open drawers which contained multiple clean supplies: gauze pads, blue clean pads, tourniquets, and transducer caps. 48966 At 10:05 AM, during a tour of the Hemodialysis Treatment Floor, a tan, two-tiered clean supply cart, located across from Station 5 contained normal saline bags, BiBags (dry bicarbonate concentrate), two boxes of tape, and blue clean pads. The cart was positioned in a manner that the cart and some of the supplies made contact with an adjacent gray trash can. At 10:46 AM, S5, a Registered Nurse, confirmed the clean supply cart should not touch the gray trash can. S5 moved the clean supply cart away from the gray trash can. 51227 At 10:09 AM, at the “lab (laboratory) specimen area,” a drinking cup, partially filled with a coffee-like liquid, was on the countertop next to the clean sink. During an interview at 10:11 AM, S9, the Charge Nurse, confirmed that food and drinks are not allowed on the hemodialysis treatment floor. S9 threw away the drinking cup. Facility policy titled, “Dialysis Precautions,” published 01/04/12, stated, “... Clean versus Dirty Areas ... Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handles or stored ... 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. ...” N.J.A.C. 8:43A-24.8(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: 48966 Based on one of one observation of the initiation of hemodialysis using a central venous catheter (CVC) (a type of access used for hemodialysis), review of facility documents, and staff interview, it was determined the facility failed to ensure the body of the catheter is cleaned during initiation of hemodialysis. Findings include: On 12/18/24 at 11:06 AM in Station 6, Staff (S) 6, a Registered Nurse, initiated hemodialysis through a right chest CVC. S6 placed a blue pad under the catheter limbs. S6 removed the red (arterial) cap off the end of the CVC, used a sterile alcohol pad and scrubbed the threads and the end of hub of the catheter for five seconds. S6 attached a syringe on the end of the arterial limb. This was five seconds less than required by facility policy. S6 proceeded to remove the blue (venous) cap off the end of the CVC, used a sterile alcohol pad and scrubbed the threads and the end of hub of the catheter for 10 seconds. S6 attached a syringe on the end of the venous limb. S6 did not clean from the hub towards the body of the catheter after cleaning the arterial and venous threads and the arterial and venous ends of the hub as required by facility policy. During an interview at 11:35 AM, S6 stated the threads of the catheter need to be scrubbed for 30 seconds with a alcohol pad. S6 confirmed that he/she did not clean from the hub towards the body of the catheter. S6’s personnel file was reviewed and indicated Annual Skills Validation on the “Coaching Report” was completed on 4/3/24, which included initiation of dialysis with a CVC and scrub the hub. Facility policy titled, “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer,” published 05/06/24, stated, “... Preparing the Catheter: Disinfection of the Catheter Connections, Heparin Removal, Flushing the Catheter and Heparin Administration Follow ... Threads and end of luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) for 1-15 seconds and any time caps are removed, or bloodlines are disconnected ... Step 2 Remove cap from clamped arterial limb ... 3 Using a sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) scrub the sides (threads) and end of the hub thoroughly with friction ... 4 Using the same sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter ...” N.J.A.C. 8:43A-24.8(b)”

“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: 37656 Based on staff interview and a review of facility documents, 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 six months RO (reverse osmosis) disinfection logs and culture and endotoxin results. Findings include: A review of the Reverse Osmosis (RO) Unit Chemical Disinfection logs and the Culture and Endotoxin laboratory results for June 2024 through November 2024 revealed the following: On 6/4/24, the RO unit was disinfected with Minncare. The culture and endotoxin samples were drawn on 6/5/24, one day after disinfection. Upon interview on 12/19/24 at 1:56 PM, Staff (S) 3, Biomedical Technician, stated that he/she forgot to draw the culture and endotoxin samples prior to disinfection and had to draw it after disinfection for the month of June. Facility policy titled, “Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems,” published 03/16/23, stated, “... Scheduled Sampling ... microbiological samples will be collected no less than monthly. ... Samples will be collected prior to disinfection and within 96 hours of system disinfection. ...” N.J.A.C. 8:43A-24.10(a)(2)”

“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: 51040 Based on observation and staff interview on 12/18/24, it was determined that the facility failed to ensure that the physical environment is maintained. Findings include: During a tour of the facility starting at 11:12 AM, in the presence of Staff (S) 3, the Biomedical Technician, the following was revealed: In the Staff Locker Room, the outlet under the staff time clock lacked a protective cover exposing live electrical wiring. A loose outlet receptacle was observed in the Conference Room. Spackle was present on the sprinkler head in the Staff Locker Room which prevents proper operation of the sprinkler head. Chipped paint was present above the clean sink across from Station 17 which exposed porous gypsum board that cannot be properly cleaned. During a tour of the Patient Treatment Area, starting at 11:25 AM, in the presence of S3, the following was observed: At Stations 4 and 5 and to the right side of the doorway near the Bio Medical area, the wall surface was chipped and cracked which exposed porous gypsum board that cannot be properly cleaned. A buildup of a white hardened substance was found around the edges of the sink and on the counter surface of the designated dirty sink, located across from Station 4. Two areas, each approximately six inches by six inches were visibly stained brown in the exit egress hallway near the Storage Room. Gypsum board was cracked, chipped and stained brown around the ceiling mounted light fixture in the Storage Room. The exterior door from the Storage Room to the generator area was visibly damaged at the bottom which can allow insects and rodents to enter the building. During an interview, S3 stated, “that was caused by standing water from when it rains.” In the Medical Supply Room, the upper cabinet door was separated from the hinge and the door was hanging. S3 confirmed the above findings on 12/18/24 at 11:45 AM. N.J.A.C. 8:43A-17.3(a)(j)(l) N.J.A.C. 8:43A-17.4(a)(15)”

“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: 37656 Based on one of one observation of the Water Treatment Room and staff interviews, it was determined the facility failed to ensure that the calibration solutions used for calibrating the phoenix meters (device used to verify the conductivity, temperature and pH [potential of hydrogen] of solutions) are maintained in accordance with the manufacturer’s instructions. Findings include: On 12/19/24 at 11:40 AM, during tour of the Water Treatment Room, in the presence of Staff (S) 3, Biomedical Technician, the following conductivity solution was expired and was available for use: Mesa Labs conductivity standard solution 14.0 mS/cm had a label indicating the date opened was 10/10/24 and the discard date was 01/08/25. The manufacturer’s instruction label on the bottle stated: “Discard 30 days after opening.” The above solution should have been discarded on 11/08/24. Upon interview at the time of discovery, S3 stated it should have been discarded. S3 discarded the solution after the interview. N.J.A.C. 8:43A-24.11(c)”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 48966 Based on one of one Central Venous Catheter (CVC) (a type of access used for hemodialysis) observation, and staff interview, it was determined that the facility failed to ensure each patient’s right to privacy. Findings include: On 12/18/24 at 11:06 AM, an initiation of dialysis via a CVC was performed by staff in Station 6. The curtains were drawn on both sides of Station 6, fully extended to ensure patient privacy on the left and right side of the patient. The curtain did not fully extend in the front of the station, leaving a two-foot opening. The patient’s exposed chest was visible to the patients sitting in Stations 12 and 13. During an interview at 11:35 AM, Staff (S) 6, a Registered Nurse, confirmed the curtains should be fully around the patient sitting in Station 6. Facility policy titled, “Patient Rights and Responsibilities,” published 04/04/12, stated, “... Policy: Privacy Rights ... Patient have the right to privacy during activities that may require the exposure of private body parts while in the dialysis facility. Privacy screens or curtains may be used to provide privacy ...” N.J.A.C. 8:43A-16.2(a)(10)”

“PA-EVAL FOR SELF CARE/MODALITY/SETTING CFR(s): 494.80(a)(9) The patient’s comprehensive assessment must include, but is not limited to, the following: (9) Evaluation of the patient’s abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process; the preferred modality (hemodialysis or peritoneal dialysis), and setting, (for example, home dialysis), and the patient’s expectations for care outcomes. This Standard is not met as evidenced by: 39228 51990 Based on one of one observation of self decannulation (the process of removing a cannula) of a thigh arteriovenous graft (AVG, an access used for hemodialysis), interviews, and review of facility documents, it was determined that the facility failed to ensure that patients receive self-care training prior to completing decannulation independently. Findings include: On 12/18/24 at 10:35 AM in Station 18, an interview was conducted with Patient (P) 8, a hemodialysis patient. During the interview, P8 stated that he/she decannulates his/her own AVG needles upon the completion of hemodialysis. On 12/18/24 at 10:37 AM in Station 18, Staff (S) 8, a Registered Nurse, removed the needle from one of P8’s AVG access sites following the completion of hemodialysis. Once the needle was removed, P8 then placed pressure on the site. At 10:47 AM, P8 removed the second AVG access site needle. After removal of the needle, P8 did not pull safety guard on the needle and then placed the needle on the side table of the recliner treatment chair with the needle exposed. P8 then applied pressure to the access needle site. On 12/19/24, a review of P8’s medical record, date of admission 09/29/19, revealed no documented evidence that P8 received self-care training to decannulate him/herself following a hemodialysis treatment. On 12/19/24 at 2:40 PM, S12, the Facility Administrator, confirmed there was no documentation of patient education on self-decannulation. Facility policy titled, “Patient Education” published 02/06/23, stated, “... Responsibility The members of the interdisciplinary team (IDT) ... all have a role in providing patient education. ... Document Patient Education Patient Education must be documented in the patient’s medical record. This may occur through the use of: Patient Education Assessment, Other interdisciplinary specific assessments, Clinical/progress notes Educating Existing Patients: Required Topics and Materials Ongoing education will be provided to patients as needed on an individualized basis. Topics not limited to and as applicable should include: ... Vascular access ...” N.J.A.C. 8:43A-24.4(a)”

“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: 39228 Based on medical record review (Patient (P) 1, P3, P4, and P7), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that post hemodialysis nursing assessments are completed according to facility policy. Findings include: A review of P1’s plan of care, dated 06/24/24, stated, “Area of Focus BP [blood pressure] and Fluid Management Open Goal Achieve BP Control as specified by the patient’s physician ... Intervention (s): ... Educate patient/family/caregiver on fluid control In Progress ... Met goal: Continue to monitor patient In Progress Monitor fluid gains ... In Progress ...” A review of the “Treatment Sheets For Facility” from 11/11/24 through 12/18/24 in P1’s medical record revealed the following: On 11/11/24, the pre-treatment (before treatment) “Nursing Evaluation” section stated, “... Edema Ankle Right, 3+[plus]: 4-6 mm [millimeters] indent, noticeably deep, last more than 1 minute, extremity swollen. Edema Lower Leg Bilateral 2+: 2-4 mm indent, disappears in 10-15 seconds. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a Registered Nurse (RN). On 11/13/24, 11/15/24 and 11/29/24, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle Bilateral , 2+: 2-4 mm indent, disappears in 10-15 seconds, 3+: 4-6 mm indent, noticeably deep, last more than 1 minute, extremity swollen. Edema Lower Leg Bilateral 2+: 2-4 mm indent, disappears in 10-15 seconds, 3+: 4-6 mm indent, noticeably deep, last more than a minute, extremity swollen. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/02/24 and 12/06/24, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle Bilateral, 2+: 2-4 mm indent, disappears in 10-15 seconds. Edema Lower Leg Bilateral 2+: 2-4 mm indent, disappears in 10-15 seconds. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/13/24, 12/16/24 and 12/18/24, the pre-treatment “Nursing Evaluation” section stated, “... Edema Ankle Bilateral, 2+: 2-4 mm indent, disappears in 10-15 seconds. Edema Lower Leg Bilateral 1+: 2 mm or less, disappears rapidly. ...” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/19/24 at 12:55 PM, the above treatment sheets were reviewed with Staff (S)13, Director of Operations and S14, the Charge Nurse. S14 confirmed the RN needs to address and document edema post treatment if present pre-treatment. 48966 A review of P7’s medical record revealed the following: A Plan of Care, dated 07/30/24, stated “Area of Focus BP and Fluid Management ... monitor fluid gains and discuss high weight gains with patient In progress ... “ A review of the “Treatment Sheets For Facility” from 11/27/24 through 12/17/24 in P7’s medical record revealed the following: On 11/27/24, 11/30/24, 12/03/24, 12/05/24, 12/10/24, 12/14/24 and 12/17/24, the pre-treatment “Nursing Evaluation” section stated, “Bilateral lower leg/ankle edema, 1+: 2 mm (millimeters) or less, disappears rapidly.” The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/07/24 and 12/12/24 the pre-treatment “Nursing Evaluation” section stated, “Bilateral lower leg/ankle edema, 2+: 2-4mm (millimeters) indent, disappears in 10-15 seconds”. The post treatment “Nursing Evaluation” at 3:33 PM lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/19/24 at 11:46 AM, the above flowsheets were reviewed with S13, the Director of Operations. S13 confirmed that the RN should reassess and document edema post treatment if edema was present pre-treatment. On 12/19/24 at 2:20 PM the above flowsheets were reviewed with S9, the Charge Nurse. S9 confirmed that the RN needs to address and document edema post treatment if present pre-treatment. 50912 A review of Patient (P) 3’s medical record indicated that he/she received hemodialysis treatments three times per week. Further review of the hemodialysis treatment flowsheets revealed the following: A review of P3’s plan of care, dated 11/22/24, stated, “Area of Focus BP and Fluid Management Open Goal Achieve BP Control as specified by the patient’s physician ... Intervention (s): ... Educate patient/family/caregiver on signs and symptoms of fluid overload ... In Progress ... Monitor fluid gains and discuss high weight gains with patient ... In Progress ...” On 11/29/24 at 4:49 AM, the pre-treatment “Nursing Evaluation” indicated bilateral ankle edema, plus one: two mm (millimeters) or less, disappears rapidly. The post-treatment “Nursing Evaluation” at 8:46 AM lacked documented evidence of a re-assessment of the bilateral ankle edema. On 12/04/24 at 4:55 AM, the pre-treatment “Nursing Evaluation” indicated bilateral ankle edema, one plus: two mm or less, disappears rapidly. The post-treatment “Nursing Evaluation” at 7:16 AM lacked documented evidence of a re-assessment of the bilateral lower ankle edema. On 12/09/24 at 4:45 AM, the pre-treatment “Nursing Evaluation” indicated bilateral lower leg, ankle, and sacral edema, one plus: two mm or less, disappears rapidly. The post-treatment “Nursing Evaluation” at 7:46 AM lacked documented evidence of a re-assessment of the bilateral lower leg, ankle, and sacral edema. On 12/11/24 at 4:53 AM, the pre-treatment “Nursing Evaluation” indicated bilateral lower leg and ankle edema, one plus: two mm or less disappears rapidly. The post-treatment “Nursing Evaluation” at 8:40 AM lacked documented evidence of a re-assessment of the bilateral lower leg and ankle edema. On 12/13/24 at 4:38 AM, the pre-treatment “Nursing Evaluation” indicated bilateral lower leg, ankle, and sacral edema, one plus: two mm or less, disappears rapidly. The post-treatment “Nursing Evaluation” at 9:18 AM lacked documented evidence of a re-assessment of the bilateral lower leg, ankle, and sacral edema. On 12/16/24 at 4:42 AM, the pre-treatment “Nursing Evaluation” indicated bilateral lower leg and ankle edema, one plus: two mm or less disappears rapidly. The post-treatment “Nursing Evaluation” at 8:25 AM lacked documented evidence of a re-assessment of the bilateral lower leg and ankle edema. During an interview on 12/19/24 at 2:28 PM, S9, the Charge Nurse, confirmed the post re-assessment of edema was not documented on the above-mentioned hemodialysis flowsheets. S9 stated that staff nurses should reassess and document post-treatment edema if abnormal findings were found pre-treatment. Facility policy titled, “Patient Assessment and Monitoring,” published 05/01/23, stated, “... Purpose ... provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during and after treatment ... Edema (As indicated by patient condition): Asses the patient for edema ... Location ... Severity ...” 51227 A review of P4’s medical record revealed the following: A Plan of Care, dated 10/09/24, stated “Area of Focus BP and Fluid Management ... continue to monitor patient’s BP and fluid gains in between treatments ... “ A review of P4’s hemodialysis “Treatment Sheets For Facility” from 11/26/24 through 12/16/24, revealed the following: During hemodialysis treatments on 11/26/24, 12/6/24, 12/9/24, 12/13/24, the pre-treatment “Nursing Evaluation” section stated, “... Bilateral lower leg/ankle edema, 2+: 2-4mm (millimeters) indent, disappears in 10-15 seconds ...”. The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. During hemodialysis treatments on 11/29/24, 12/02/24, 12/04/24, 12/11/24, 12/16/24, the pre-treatment “Nursing Evaluation” section stated, “... Bilateral lower leg/ankle edema, 3+: 4-6mm indent, noticeably deep, last more than 1 minute, extremity swollen ...”. The post treatment “Nursing Evaluation” lacked documented evidence of a re-assessment of the patient’s edema by a RN. On 12/19/24 at 2:20 PM, the above flowsheets were reviewed with S9, the Charge Nurse. S9 confirmed the RN needs to address and document edema post treatment if present pre-treatment. Facility policy titled, “Patient Assessment and Monitoring,” published 05/01/23, stated, “ ... Pre-Treatment ... 2 ... Edema (As indicated by patient condition) Assess the patient for edema: [bullet] Location: foot, ankle, lower leg and sacrum. [bullet] Right, Left or Bilateral [bullet] Severity (None, 1+, 2+,3+ or 4+) 3 Document findings and interventions in the medical record. ... Post-Treatment ... 1 ... Edema The registered nurse will assess/re-assess post treatment as indicated. 2 Document findings in the patient’s record. ...” N.J.A.C. 8:43A-24.6(d)(3)”

“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: 39228 Based on staff interview, review of two of eight medical records (Patient (P) 1 and P3) and review of facility documents, it was determined that the facility failed ensure the patients receive the prescribed BFR (Blood Flow Rate, the speed at which blood is pumped through the dialyzer during hemodialysis) and DFR (Dialysate Flow Rate, the rate at which the dialysate passes through the dialyzer during hemodialysis). Findings include: A review of P1’s plan of care dated, 06/24/24, stated, “Area of Focus Dialysis Adequacy (IHD) Access Open ... Intervention (s): Continue to monitor patient In Progress ...” A review of P1’s treatment records revealed the prescribed BFR for this patient was 450 milliliters per minute (450 mL/min). Further review revealed the following: On 11/29/24, the BFR for P1 was set at 300 mL/min from the initiation of treatment at 10:22 AM until 11:03 AM, when it was changed to 450 mL/min; at 1:28 PM, the BFR was changed to 345 mL/min; at 2:00 PM, the BFR was changed to 325 mL/min until 2:22 PM, when the treatment was ended. On 12/02/24, at the initiation of treatment at 10:52 AM, the BFR for P1 was set at 450 mL/min; at 12:01 PM, the BFR was changed to 400 mL/min; at 1:39 PM, the BFR was changed to 300 mL/min; at 2:05 PM, the BFR was changed to 200 mL/min, when the treatment ended. On 12/06/24, at the initiation of treatment at 10:01 AM, the BFR for P1 was set at 400 mL/min and remained at 400 ml/min; at 2:16 PM, when treatment ended, the BFR was set at 200 mL/min. On 12/16/24, at the initiation of treatment at 10:22 AM, the BFR for P1 was set at 450 mL/min; at 12:02 PM, the BFR was changed to 400 mL/min; at 2:00 PM, the BFR was changed to 300 mL/min; at 2:22 PM, when the treatment ended, the BFR was changed to 200 mL/min. On 12/18/24, at the initiation of treatment at 11:03 AM, the BFR for P1 was set at 200 mL/min; at, 11:38 AM, the BFR was changed to 300 mL/min; at 1:07 PM, the BFR was changed to 350 mL/min; at 1:32 PM, the BFR was changed to 400 mL/min; at 2:04 PM, the BFR was changed to 350 mL/min, at 2:32 PM, the BFR was changed to 300 mL/min until 2:52 PM, when the treatment ended. There was no documentation found in the medical record that the Patient Care Technician (PCT) notified the Registered Nurse (RN) of the change in BFR, or that the RN notified the physician that the BFR was set lower than the prescribed rate. Also, there was no documentation found in the record to indicate the reason for the change in BFR on the following dates: 12/2/24, 12/6/24, and 12/16/24. During an interview on 12/19/24 at 12:55 PM, S13, Director of Operations and S14, the Charge Nurse confirmed that the dialysis prescriptions for P1 were not administered according to the physician order on the above dates and that the documentation on the treatment records lacked notification of the RN by the PCT that the BFR had been adjusted, or notification of the physician to obtain an order by the RN to change the BFR. S14 provided the physicians orders for hemodialysis for the above dates which did not include any orders for the changes in BFR’s indicated above. 50912 A review of P3’s plan of care dated, 11/22/24, stated, “Area of Focus Dialysis Adequacy (HD) ... Issues: Open ... Patient is not meeting spKt/V goal. 1.23 as of 11/04.24 ... in Progress ...” A review of P3’s medical record revealed the following: The “Hemodialysis Orders” section dated 11/26/24, included a physician order for a DFR of “800 mL/min (milliliters/minute).” A review of hemodialysis treatment sheets, “Treatment Sheet for Facility,” from 11/26/24 to 12/18/24 indicated that the prescribed DFR was not followed on the following treatment dates: On 12/4/24, P3 was dialyzed with a DFR of 500 from the initiation of the treatment at 5:07 AM until the end of the treatment at 6:33 AM (one hour and twenty-six minutes). On 12/18/24, P3 was dialyzed with a DFR of 500 from the initiation of the treatment at 5:06 AM until the end of the treatment at 7:38 AM (two hours and thirty minutes). The medical record lacked documented evidence of a rationale for a lowered DFR rate of 500 ml/min instead of the prescribed DFR of 800 ml/min and physician notification on the above dates. The “Hemodialysis Orders” section dated 12/04/24, included a physician order for a BFR of “450 mL/min (milliliters/minute)”. On 12/11/24, P3 was dialyzed with a BFR of 400 from 6:02 AM until 7:32 AM (one hour and 30 minutes). On 12/13/24, P3 was dialyzed with a BFR of 400 from 5:01 AM until 7:41 AM (two hours and 40 minutes). The medical record lacked documented evidence of a rationale for a lowered BFR rate of 400 ml/min instead of the prescribed BFR rate of 450 ml/min and physician notification on the above dates. On 12/19/24 at 2:28 PM, the above findings were reviewed with S9, the Charge Nurse. S9 stated that staff members should write a comment about why they cannot achieve the prescribed BFR and notify the physician. Facility policy titled, “Nursing Supervision and Delegation” published 11/06/23, stated, “... Reporting of Patient Care Findings to the Team Nurse in Charge ... The staff member who collects information pre, post and during treatment will document their findings. Any observed changes or abnormal findings ... must be reported to the registered nurse who will assess the patient. ... Daily Treatment Record Review Prior to discharge, the RN must review the treatment record ... The record must be reviewed for: ... correct dialysate prescription was delivered. ...” Facility policy titled, “Physician Order Documentation” published 07/03/23, stated, “... General Policy Nurse practice act requires nurses to carry out treatment care, ... based on physician orders. ...” Facility policy titled, “Patient Assessment and Monitoring” published 05/01/23, stated, “... Data Collection ... Direct patient care staff may collect data ... If the PCT... note any changes in the patients condition or vascular access ... the registered nurse must assess the patient. ... The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed. ... During Treatment ... Document machine parameters ... every 30 or more often as needed ... Follow the steps below for monitoring ... machine parameters during treatment ... Machine Parameters and Extracorporeal Circuit ... Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered ... Document any findings and interventions in the medical record” N.J.A.C. 8:43A-24.4(a) N.J.A.C. 8:43A-24.13(b)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 39228 Based on three of four observations of the initiation of hemodialysis through an arteriovenous graft/fistula (AVG/F) (a type of vascular access used for hemodialysis), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 12/18/24 at 10:15 AM in Station 3, Staff (S) 10, a Patient Care Technician (PCT), initiated dialysis through a patient’s AVG. S10 cleansed the first site of the AVG with an alcohol pad in a circular motion for seven seconds then cannulated (the act of inserting a needle into the vascular access). At 10:16 AM, S10 cleansed the second site of the AVG with an alcohol pad in a circular motion for 12 seconds then cannulated. During an interview at 10:22 AM, S10 stated he/she should clean each site of the access for at least 30 seconds with alcohol. 48966 On 12/18/24 at 10:12 AM at Station 21, S4, a PCT, initiated dialysis through a patient’s AVG. S4 cleansed the first site of the AVG with an alcohol pad in a circular motion for 20 seconds then immediately cannulated. S14 cleansed the second site of the AVG with an alcohol pad in a circular motion for 20 seconds then immediately cannulated. This is ten seconds less than required by facility policy. During an interview at 10:33 AM, S4 stated he/she should clean the each site of the access for 30 seconds with alcohol but was unsure of the dry time. 51227 On 12/18/24 at 10:15 AM, in Station 11, S7, a PCT, initiated hemodialysis through an AVG. S7 cleansed the first site of the AVG with alcohol in a circular motion for 20 seconds. This is 10 seconds less than required per facility policy. S7 then cleaned the second site with alcohol for 20 seconds. This is 10 seconds less than required by facility policy. During an interview at 10:35 AM, S7 stated that each site should be cleaned with alcohol for 30 seconds. Facility policy titled, “Access Assessment and Cannulation,” published 05/06/24, stated, “... Skin Disinfection ... Disinfect cannulation site as follows ... 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating. ... Perform skin antisepsis on one site at a time, allow to dry and them [sic] cannulate. ...” N.J.A.C. 8:43A-24.4(b)”

“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 observation, medical record review, staff interviews, and a review of facility documents, it was determined that the Medical Director failed to ensure that: 1) verbal or telephone orders given by the physician are entered into the medical record for seven of seven medical records reviewed for shortened treatments for Patient (P)1, P4, P9, P10, P11, P12, and P13; and 2) the expiration dates of medications are monitored and discarded according to the manufacturer’s expiration dates. Findings include: 1. A review of the treatment flow sheets dated 12/2/24 for the following patients indicated that the treatments were shortened for three hours: P1, P4, P9, P10, P11, P12, and P13. The medical records contained notes on all of the above patients’ medical records from Staff (S) 9, Charge Nurse, that stated, “Opening the unit this morning was delayed due to pipe breaking and water flooding the unit. Medical Director, FA [Facility Administrator], CM [Clinic Manager], and Biomed [Biomedical] all made aware. Biomed was able to fix the pipe and treatments were started by 8:30 AM. Medical Director gave orders for all patients to run three hour treatments if medically appropriate.” The medical records lacked evidence that the physician orders were entered into each patients medical records upon receiving the order from the Medical Director. During an interview on 12/20/24 at 12:30 PM, S9 stated that he/she entered the nurse’s notes for all the patients’ shortened treatments on 12/02/24 and confirmed that there was no order entered when he/she received the telephone order from the Medical Director. Facility policy titled, “Physician Order Documentation,” published 07/03/23, stated, “... General Policy ... Nurse practice acts require nurses to carry out treatment care ..., based on physician orders. ... These orders can be entered electronically, given by telephone, ... Telephone Orders ... must be: ... Taken by a licensed nurse who is employed by FKC directly from the physician or physician’s agent (ex. APN, PA) ... Recorded in the medical record. ... Signed by the physician, at the time of the physician’s next facility visit. The orders must be signed, within 30 days, or earlier if required by state law, ...” N.J.A.C. 8:43A-7.4(a)(3) 51227 2. On 12/18/24 at 1:52 PM, the Medication Room was inspected, and the following was observed: The second shelf of the Medication Room refrigerator contained two boxes with 10 vials in each box of expired 20,000 units per ml (milliliter) of Retacrit Epoetin Alfa-epbx recombinant (a medication used to treat anemia). The expiration date was 10/31/24. During an interview at 2:00 PM, S5, a Registered Nurse (RN), said the charge nurse usually checks the Medication Room for expired medications. During an interview at 2:15 PM, S9, a Charge Nurse, stated they typically check for expired medications monthly and will remove the expired medications from the refrigerator. When asked if they have any patients currently taking Retacrit, he/she explained that they do. Facility policy titled, “Medication Preparation and Administration,” revised 02/06/23, stated, “... Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law. ...” N.J.A.C 8:43A-9.5(f)”