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“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 51990 Based on 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 testing for residual disinfectant after weekly CWP (Continuous Water Purification, reverse osmosis [RO] water system) disinfection is performed (Tag V-219). This failure resulted in an Immediate Jeopardy (IJ), posing serious risk of harm to the patients; and to ensure microbiological samples (culture testing for colony count and endotoxins) are collected in accordance with facility policy in three of six months of microbial monitoring reviewed (Tag V-254). On 08/13/25 at 1:24 PM, an IJ was identified for the facility’s failure to ensure that policies and procedures for testing for residual disinfectant after weekly CWP disinfection were adhered to by staff. The Clinic Manager and the Director of Operations were informed of the IJ findings, and a copy of the IJ template was provided at 4:42 PM. An acceptable removal plan was received on 8/14/25 at 9:40 AM. The facility implemented the following: a Governing Body (GB) meeting was held to execute a Removal Plan for the immediacy of the IJ and staff re-education was conducted. On 08/14/25 at 10:15 AM, the surveyors were able to verify implementation of the Removal Plan through facility document review, staff interviews, and review of the staff education documentation. The IJ was removed on 08/14/25 at 10:30 AM and Condition level non-compliance remains. Cross reference: 42 CFR 494.40(a) - Bact Control-Disinfect 1x/mo/dwell; Microb Monitor Sample Before Disinfect”

“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: 51990 Based on observation, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that one of one emergency cart contains a comprehensive checklist of supplies, expired equipment is not available for use, and one of one emergency evacuation box contains a comprehensive checklist of supplies and the list of the staff emergency contact information in accordance with facility policy Findings include: On 08/12/25 at 11:57 AM, in the In-Center Treatment Area, the facility’s emergency cart and emergency evacuation box, were reviewed and revealed the following: The emergency cart binder, located on the emergency cart contained a manual checklist titled, “Emergency Code Cart, Medication and Hand Crank Checklist.” The checklist indicated the cart was last reviewed in 08/2025. The checklist indicated that the cart contained two sets of AED (Automated External Defibrillator) pads with expiration dates of 10/19/26. However, the cart contained three AED pads, and one of the three AED pad expired on 02/18/25. Staff (S)1 also provided an electronic checklist completed by staff for the emergency cart titled, “Emergency Code Cart and Medication Checklist (Monthly).” The electronic checklist stated that there were two AED pads with an expiration date of 10/19/26. During an interview on 08/12/25 at 12:10 PM, S4 confirmed that the cart was checked monthly by an RN and confirmed one of the three AED pads was expired. At 12:25 PM, the emergency box binder, located on the emergency box contained a manual checklist titled, “Emergency Box Contents,” that indicated the box was checked in 08/2025. The checklist indicated a portable radio was “NA” (not available). However, the emergency box contained one portable radio. The checklist also indicated that the staff emergency contact information was present in the box. However, the box did not contain the staff contact information. S1 also provided an electronic checklist completed by staff for the emergency cart titled “Emergency Box Contents Log Incenter (Monthly).” The electronic checklist stated that the box contained a portable radio which is not in accordance with the above checklist documentation. During an interview on 08/12/25 at 12:35 PM, S1 confirmed the emergency evacuation box contained a portable radio and did not have the staff emergency contact. Facility policy titled, “Emergency Medications, Equipment and Supplies,” published 07/07/25, stated, “... Emergency Cart ... The emergency cart must be: ... Checked monthly or after use for contents, expiration dates, ... Emergency Evacuation Box ... An emergency evacuation box must: ... Contain all patient and staff emergency contact information ... An itemized log must be kept indicating the contents ...””

“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: 51990 Based on two of two observations of hand hygiene during the initiation of dialysis through a Arteriovenous Fistula [AVF, a type of vascular access used for hemodialysis (HD)] and a Central Venous Catheter (CVC, a type of access used for HD), staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that hand hygiene is performed to prevent cross contamination in accordance with facility policy. Findings include: On 08/12/25 during a tour of the In-Center Hemodialysis Area, the following was revealed: At 10:24 AM in Station 11, during an observation of the initiation of HD treatment on Patient (P)10 through a left AVF, Staff (S)4, with gloved hands, entered the patient station and performed an assessment (listened to heart and lung sounds, checked for edema). Upon completion, S4 exited the station, removed his/her gloves, did not perform hand hygiene, then applied clean gloves. S4 re-entered the patient station, typed on the keyboard of the dialysis machine and entered the patient’s assessment information. He/she then exited the patient station, removed his/her gloves and did not perform hand hygiene. At 10:42 AM, during an interview, S4 stated that he/she should have used hand sanitizer when changing gloves. At 11:38 AM in Station 10, S1 completed the initiation of HD treatment on P9 through a CVC, then exited the station, removed his/her gloves and performed hand hygiene. S1 then with ungloved hands touched a sharp’s container that was outside of the patient station and re-entered Station 10 with the sharp’s container. S1 did not perform hand hygiene, applied clean gloves and then proceeded to discard the used syringes. During an interview at 11:45 AM, S5 stated that hand hygiene should be performed during glove changes. A review of S4’s personnel file indicated that Infection Prevention Fundamentals training was completed on 08/07/25. A review of S1’s personnel file indicated that Infection Prevention Fundamentals training was completed on 08/04/25. Facility policy titled, “ Hand Hygiene,” published 11/06/23, stated, “... Policy ... Hands Will Be ... Decontaminated using alcohol- based hand rub or by washing hands with antimicrobial soap and water ... Before and after direct contact with patient ... Entering and leaving treatment area ... Immediately after removing gloves ... After contact with inanimate objects near the patient ... After contact with other objects within the patient station or treatment space ...””

“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: 51990 Based on two of two observations, staff interviews, and review of facility documents, it was determined that the facility failed to clearly designate clean areas from dirty areas to avoid possible cross contamination. Findings include: On 08/12/25, during a tour of the In-Center Hemodialysis Treatment Area, the following was revealed: At 10:14 AM in Station 9, Staff (S)4 discontinued hemodialysis on Patient (P)11. S4 then emptied the used Naturalyte acid jug and discarded the acid fluid into the clean hand washing sink located across from the patient scale area. S4 then returned to the patient station and removed the prime waste receptacle bucket from the dialysis machine. He/she then discarded the fluid from the prime bucket into the clean hand washing sink located across from Station 11 and Station 12. During an interview at 10:25 AM, S4 confirmed that handwashing sinks were clean sinks and stated that the fluid should have been discarded in the dirty sink. At 11:45 AM across from Station 11 and Station 12, a trash receptacle touched a gray clean supply cart that contained a box of band aids, a box of facial masks, two boxes of tapes, a box of alcohol pads, two boxes of stretch gauze, six boxes of gloves, a stack of blue pads, six boxes of 2x2 gauze pads, three boxes of 4x4 gauze pads on the top shelf and; 8 unopened 2K (potassium) Naturalyte gallon jugs on the bottom shelf. During an interview on at 11:58 AM, S5 confirmed that the gray cart contained clean supplies, and the trash receptacle should not have touched the cart. Facility policy titled, “Hand Hygiene,” published 11/06/23, stated, “ ... Sink Policy ... Hand washing sinks should be dedicated for hand washing only and should remain clean ... Used items should not be placed or drained in the hand washing sink ...” Facility policy titled, “General Cleanliness and Infection Control Guidelines,” published 05/05/25, stated, “... Policy ... All areas must be kept clean and organized, including but not limited to treatment areas, ...””

“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: 37656 Based on observation, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that four out of 12 blood pressure (BP) cuffs are maintained to allow for adequate cleaning and disinfection in accordance with facility policy. Findings include: On 08/12/25 at 10:45 AM, during tour of the Hemodialysis Treatment Floor, the BP cuffs in Stations 3, 5, 7, and 9, were covered with white lint on the Velcro portion of the cuff, which rendered the BP cuffs uncleanable. Upon interview at 11:00 AM, Staff (S) 4, stated that they will mention it to their Clinic Manager and will change the BP cuffs. Facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 09/05/23, stated, “... Definition ... Area including the dialysis machine, chair bed and other reusable equipment or supplies utilized during treatment ... may include ... IV [intravenous] pole, BP cuff ... after use, any non-disposable equipment ... must be disinfected with 1:100 bleach or EPA [Environmental Protection Agency] registered disinfectant. ...””

“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: 50912 Based on review of medical records, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that patients who are susceptible to the Hepatitis B Virus (HBV) are tested monthly for the Hepatitis B surface Antigen (HBsAg) in two of 48 patients reviewed (Patients [P]6 and P7). Findings include: Reference: The Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), dated 04/27/01, states, “Prevention and Management of HBV Infection ... Preventing HBV (Hepatitis B Virus) transmission among chronic hemodialysis patients requires a) infection control precautions recommended for all hemodialysis patients b) routine serologic testing for markers of HBV infection and prompt review of results ... Immunogenicity defined as greater or equal to 10 milliliter (ml) - International Units (IU) in 90 percent to 95 percent of adults with normal immune status. The need for routine follow-up testing and vaccination, or isolation is based on patients’ serologic status ... HBV susceptible patients ... test susceptible patients monthly for HBsAg, including those who have not yet received Hepatitis B vaccine, b) are in the process of being vaccinated or c) have not adequately responded to vaccination. According to the table, Schedule for Routine testing for Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Infections: HBV - susceptible including non-responders to vaccine - Monthly testing for HBsAg ...” A review of the Hepatitis B Lab (Laboratory) Results Summary from July 2024 through July 2025 indicated the following: P6 had an anti-HBs (Hepatitis B surface antibody) test result of less than 10 mIU/ML on 03/19/25, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in April, May, June, and July 2025. P7 had an anti-HBs test result of less than 10 mIU/ML (milli-international units per milliliter) on 06/13/25, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg surveillance test in July 2025. On 08/13/25 at 2:10 PM, review of the above findings was completed with Staff (S)1, who confirmed that the above laboratory testing was missed. Facility policy titled, “Patient Hepatitis B Testing Requirements,” published 02/03/25, stated, “... HBV Patient Testing ... Hepatitis B Laboratory testing is required for all patients based upon immunity status. ... Patient Status ... Susceptible ... HBsAg: Negative ... Anti-HBs: less than 10 mlU/ml ... Anti-HBc “total”: Negative ... HBsAg ... Monthly Testing ...””

“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: 51990 Based on a review of facility documents and staff interviews, it was determined that the facility failed to ensure testing for residual disinfectant is performed after weekly CWP (Continuous Water Purification, reverse osmosis [RO] water system) disinfection with Minncare (a chemical disinfectant) in four of six disinfections, in accordance with manufacturer’s instructions for use. Findings include: A review of facility logs titled, “CWP Disinfect Start” and “CWP Disinfect End” from February 2025 to July 2025 revealed the following: CWP chemical disinfectant (Minncare) disinfection was performed on 03/04/25, 05/14/25, 06/24/25, and 07/18/25 by the staff. The log did not contain evidence of the residual testing for the disinfectant (Minncare) after disinfection by staff on the following dates: 03/05/25, 05/15/25, 06/25/25, and 07/19/25 in accordance with the manufacturer’s instruction for use. During an interview on 8/13/25 at 11:00 AM, Staff (S)2 confirmed that there was no evidence of residual testing after disinfection in the above dates. A follow-up interview at 1:15 PM, S2 stated there was no documented evidence of testing for residual disinfectant for the above dates. In a follow up interview on 08/13/25 at 3:45 PM, S1 stated that the CWP chemical disinfection schedule was changed in February from Thursdays to Tuesdays. S1 stated a verbal staff huddle was held and a decision was made to change the day of CWP disinfection to Tuesday. S1 stated that the education was verbally provided to the Patient Care Technicians (PCTs) who perform the disinfection and residual checks approximately 3 weeks prior to the change. S1 stated that there was no documentation of the education, and who were educated during the huddle. Manufacturer’s instruction for use for CWP 100, Model WRO H/S, stated, “... 3.6.2 Disinfectant Information ... Minncare Cold Sterilant ... A test for residual disinfectant after rinse must be performed before the next dialysis session ...””

“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: 51990 Based on review of facility documents and staff interviews, it was determined that the facility failed to ensure microbiological samples (culture testing for colony count and endotoxins) are collected in accordance with facility policy in three of six months of microbial monitoring reviewed. Findings include: A review of facility logs titled, “CWP (Continuous Water Purification, reverse osmosis [RO] water system) Disinfect Start” and “Environmental CQI (Continuous Quality Improvement)” from February 2025 to July 2025 revealed the following: On 03/11/25, CWP disinfection was performed. On 03/13/25, 48 hours after disinfection, culture and endotoxin samples were collected. On 06/10/25, CWP disinfection was performed. On 06/12/25, 48 hours after disinfection, culture and endotoxin samples were collected. On 07/08/25, CWP disinfection was performed. On 07/10/25, 48 hours after disinfection, culture and endotoxin samples were collected. During an interview on 08/13/25 at 11:25 AM Staff (S)2 confirmed the above findings. The surveyor then questioned S2 regarding the culture testing performed post CWP disinfection, he/she stated, “That’s how I always did it.” Facility policy titled, “Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems,” published 02/03/25, stated, “ ... Scheduled Sampling ... Samples will be collected prior to disinfection and within 96 hours of system disinfection ...””

“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: 33557 Based on observation and staff interview, it was determined that the facility failed to ensure ceilings are maintained to ensure the safety of patients. Findings include: During a tour of the Patient Treatment Floor on 8/14/25 at 10:35 AM in the presence of Staff (S)2, one ceiling tile located in Station 3, 4, 5, and the Separation Room were stained brown and discolored. During an interview on 8/14/25 at 10:35 AM, S2 confirmed the above finding and stated, “We have a problem in the summer with pipes sweating in the ceiling.””

“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: 51990 Based on two of two observations of the initiation of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interviews and review of facility documents, it was determined that the facility failed to ensure patient’s rights to privacy. Findings include: On 08/12/25, during a tour of the Hemodialysis Treatment Floor, the following was revealed: At 11:12 AM in Station 10, Patient (P)9 sat in the treatment chair and lifted his/her shirt to expose their right chest wall CVC. Staff (S)4 closed the privacy curtains to the left and the right side of the station then proceeded to exit the station. The front of the station was left opened. As a result, P9’s chest was visible from the nurse’s station, staff and to several patient that were observed to walk by the station. At 11:30 AM, eighteen minutes later, S1 returned to the station to initiated hemodialysis on P9. S1 pulled the privacy curtains from the left and right sides toward the front of the station. However, an approximate two-foot opening remained in front of the patient’s station, leaving P9’s chest visible from the nurse’s station. During an interview 08/12/25 at 11:45 AM, S4 confirmed that the curtains should be fully closed around the patient station when initiating and terminating hemodialysis. At 11:50 AM, in Station 5, S4 initiated dialysis on P12 through a left chest CVC. The privacy curtain was not fully closed, leaving an approximate three feet opening in front of the patient station. As a result, P12’s chest was visible from the nurse’s station by one patient and two staff members who walked by. Upon interview at 12:05 PM, S4 stated the curtains should have been closed all the way to cover the entire station. Facility policy titled, “Patient Rights and Responsibilities,” published 04/04/12, stated, “... Policy: Privacy Rights ... Patients 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 ...” 37656”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 33557 Based on observation, staff interview, and document review, it was determined that the facility failed to ensure medical records are securely stored to protect patient confidentiality. Findings include: On 08/12/25 at 11:34 AM, on the countertop ledge at the Nurse’s Station located across from the hallway that leads to the patient Treatment Floor entrance door, was a rectangle shaped, black colored, wire bin that was open on the top. The bin had a pile of paper documents inside. The top document in the bin was a dialysis patient’s plan of care (POC) that had the patients name, medical record number, date of birth and other health information documented on it. Further review of the documents inside the bin revealed they were paper copies of medical record information for several in-center dialysis patients at the facility. At 11:42 AM, Patient (P)14 entered the Treatment Floor entrance door, proceeded down the hallway, approached the countertop area at the nurse’s station where the bin was located and placed his/her wallet and keys directly on the countertop next to the bin, giving the patient a direct view of the top medical record document in the bin. P14 then walked over to the scale, was weighed, and then returned to the countertop area to retrieve his/her wallet and keys. On 08/12/25 at 11:50 AM, an interview was conducted with Staff (S)3, who reviewed the documents in the bin and stated that it contained in-center dialysis patient’s POC’s. S3 further stated the bin should not be placed on the countertop area and should be kept behind the nurses’ station, out of view, to safeguard the information. During a tour of the facility on 8/14/25 at 10:25 AM in the presence of S2, 17 boxes of medical records were found in an unlocked Storage Room next to the Staff Lounge. A sign on the Storage Room door read, “Do not lock this door.” During an interview at the time of discovery, S2 stated, “These medical records are waiting to be shipped to storage.” Facility policy titled, “Medical Record Guidelines,” published: 11/04/24 stated, “... Safeguarding the Medical Record Each facility must safeguard patient medical records against ... unauthorized use ... Ownership of Medical records ...The facility will safeguard the information in the record against loss, defacement, tampering, or use by unauthorized persons ...” 39228”

“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, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that staff assess patients for edema (fluid build-up in the body tissues) and lung sounds post (after) hemodialysis treatment in accordance with facility policy in seven out of 10 treatment sheets reviewed for Patient (P)3. Findings include: A review of P3’s Plan of Care (POC), dated 03/20/25, stated, “Area of Focus BP [blood pressure] and Fluid Management: Goal Achieve BP Control as specified by the patient’s physician ... Intervention (s): ... Met Goal: Continue to monitor patient ... Monitor fluid gains ...” A review of the “Treatment Sheets for Facility” from 07/21/25 through 08/11/25 in P3’s medical record revealed the following: On 07/23/25, 07/25/25, and 08/08/25, the pre-treatment (before treatment) Nursing Evaluation, stated, “... Lungs Decreased breath sounds Ankle - severity, 1+ [one plus]: 2 mm [millimeters] or less, disappears rapidly Edema Ankle -Location Bilateral ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the lung sounds and ankle edema. On 07/28/25 and 08/11/25, the pre-treatment Nursing Evaluation, stated, “... Lungs Decreased breath sounds ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the lung sounds. On 08/04/25, the pre-treatment Nursing Evaluation stated, “... Lungs Decreased breath sounds Ankle - Severity 1+: 2 mm or less, disappears rapidly Lower Leg - Severity 1+: 2 mm or less, disappears rapidly ... Edema Lower Leg - Location Bilateral Edema Ankle -Location Bilateral ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the lung sounds and ankle edema. On 08/06/25, the pre-treatment Nursing Evaluation stated, “... Fluid Assessment Symptoms ... Dyspnea on Exertion Lungs Decreased breath sounds ...” The post-treatment Nursing Evaluation lacked documented evidence of a re-assessment of the lung sounds. On 08/13/25 at 11:30 AM, the treatment sheets were reviewed with Staff (S)1, who confirmed that the post-treatment assessments for lung sounds, and edema were not completed by the Registered Nurse on the above dates. Facility policy titled, “Patient Assessment and Monitoring,” published 05/01/23, stated, “... Purpose ... provide guidance to (facility name) direct patient care staff on assessment and monitoring patients before, during and after treatment ... Pre-Treatment ... Lung sounds ... Auscultate lung sounds: Sound: ... Decreased breath sounds ... Edema ... Assess the patient for edema ... Location ... Severity ... Post-Treatment Follow the steps below for obtaining post-treatment assessing data: ... 1. The direct patient care staff may obtain the following: ... Lung sounds Edema ... The Registered Nurse will assess/re-assess post treatment as indicated ... 2. Document findings in the patient’s record ...””

“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, staff interview, and a review of facility documents, it was determined that the Medical Director failed to ensure that: 1) medications, needles and syringes are kept in locked storage areas; and 2) pre-drawn medications are labeled for two of two patients (Patient (P)1 and P10), in accordance with facility policy. Findings include: 1. On 08/12/25, during a tour of the Hemodialysis Treatment Floor, the following was revealed: At 10:25 AM, in Patient Room 13, which was unoccupied by a patient and staff member, there was a labeled pre-drawn syringe that contained three milliliters (ml) of heparin (a medication used to prevent blood clots) on the dialysis chair side table. At 10:35 AM, an interview was conducted with Staff (S)4 who stated that he/she prepared the heparin syringe at 10:00 AM and placed it on the chairside table when he/she set up the room for a patient. S4 stated the medication syringe should be in a locked drawer until use. At 10:25 AM until 11:30 AM, an opened heparin multi-dose vial containing 30,000 units with an opened date of 08/12/25, was on the countertop of the medication preparation area, unsecured. At 11:30 AM, S4 prepared the heparin for use on a patient. Upon interview at that time, S4 stated that he/she usually locks the heparin inside a drawer when not in use. At 11:12 AM, a five drawer portable cart with a locking mechanism was observed across from Station 6. Upon inspection of the cart, the five drawers were unlocked and easily opened. The second drawer from the top contained greater than 50, 10 millimeter (ml) syringes; 48, 15-gauge (g) fistula needles; and eight 16g fistula needles. The fifth drawer from top contained 22, 10 ml pre-filled 0.9% Sodium Chloride Injection syringes. Upon interview at 11:20 AM, this finding was confirmed with S1, who stated the cart “is usually kept locked.” At 11:58 AM at the Patient Care Technician Station, there were six unlocked drawers that contained needles: Drawer 1 contained three HD (hemodialysis) initiation packs with three 16g fistula needles; Drawer 2 contained 13 HD initiation packs with 16g fistula needles; Drawer 3 contained four HD initiation packs with 15g fistula needles; Drawer 4 contained nine HD initiation packs with 15g fistula needles; Drawer 5 contained 57 HD initiation packs with 15g fistula needles; and Drawer 6 contained three boxes of Vacutainer Eclipse with needles. During an interview on 08/12/25 at 12:00 PM, S5 stated the HD initiation packs were made in the morning and that the drawers should have been locked. He/she also stated the drawer with the vacutainer with the needles should have been locked. Facility policy titled, “Medication Preparation and Administration,” published 07/07/25, stated, “... Securement: The following steps must be taken for the securement: All medications will be kept in locked cabinet except when in use. ... There are states that may require securement of syringes and or needles in addition to medication (ex: NJ [example: New Jersey]). Ensure syringes and or needles are secure if per state requirements ...” 2. On 08/12/25 during the tour of the Hemodialysis Treatment Floor, the following was revealed: At 10:24 AM, in Station 11, which was occupied by P10, a labeled pre-drawn medication syringe was found on the dialysis chair side table. The syringe contained 4 mls of heparin and was labeled with the patient’s name, the dose (heparin 1mL:1000 units), and the date (08/12/25). However, the “time” and “initials” sections of the label were blank. During an interview at 10:55 AM, S4 confirmed that the heparin was drawn at 10:00 AM and that the pre-drawn medication should be labeled with the time it was drawn and initialed by the RN (Registered Nurse) who prepared it. At 10:25 AM, during a tour of the Hemodialysis Treatment Floor, one syringe, which contained clear liquid, was found unattended in Patient Room 13 on the dialysis chairside table. The syringe had a white label affixed that had P1’s name, the date it was prepared and that it contained heparin. The label included an area that stated, “Time: __” with a blank space and “Initials: __” with a blank space. The syringe lacked documentation of the time that it was prepared and the staff member who prepared it. At 10:35 AM, an interview was conducted with S4 who stated that he/she prepared the heparin on 08/12/25 at 10:00 AM, but did not time or initial the syringe when he/she prepared it. Facility policy titled, “Medication Preparation and Administration,” published 07/07/25, stated, “... Labeling Reconstituted Medication Solutions and Syringes All medications in syringes not being administered immediately shall be labeled appropriately with the ... time and initials of the person who prepared the medication. ...” 39228 51990”