Fresenius Kidney Care Richmond South

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 46466 Based on the scope and severity of deficiencies related to infection prevention and control, the facility staff failed to substantially comply with this condition. The facility staff failed to maintain a sanitary environment (V111); wear gloves and perform hand hygiene appropriately (refer to V113); failed to ensure clean areas were not contaminated (refer to V117); failed to properly disinfect dialysis stations (refer to V122); failed to test patients for Hepatitis B according to schedule (refer to V124); failed to perform monthly infection control audits (refer to V142); failed to remove expired medications and label vials appropriately (refer to V143); and failed to use aseptic technique when accessing an arteriovenous (AV) fistula/graft (refer to V550).”

“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: 46466 Based on observation and facility document review, it was determined the facility staff failed to perform monthly crash kit checks which led to the failure of removing expired medications and supplies from the crash cart. The findings include: On September 4, 2024 at 10:00 AM, the surveyor found the “Emergency Code Cart, Medications and Machine Crash Cart Checklist” laying on top of the facility’s crash cart. The checklist had not been completed since March, 2024. Inside the crash cart, the surveyor found two (2) expired Yankauer suction tubes that expired on March 12, 2024 and ten (10) vials of naloxone that had expired on June 30, 2024. A review of the facility’s policy “Emergency Medications, Equipment and Supplies”, published 5/1/2023 documented in part: “...Emergency Cart...The emergency cart must be...Checked monthly or after use for contents, expiration dates...Items approaching expiration must be reordered and replaced prior to the actual expiration date...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 46466 Based on interview, medical record and facility document review, it was determined the facility failed to perform quarterly patient fire safety training for three (3) of six (6) patient records sampled. The findings include: On September 4 and September 5, 2024, a review of six (6) sampled patient medical records was conducted. Patient #2, #4 and #5’s medical records did not contain documented evidence to support that these patients received quarterly fire drill training. The request was made to Staff Members #1 and #2 to provide the documentation, but they were unable to provide the documentation prior the surveyors exit from the facility. A review of the facility’s policy “Guidelines for Emergency Preparedness”, published 7/3/23, documented in part: “...QAI Documentation: Quarterly, all (facility) patients must receive fire drill and emergency evacuation training. Training must be documented in QAI and on the fire drill attendance form. All drills: Fire, emergency evacuation, tabletop and community-based drill must be reviewed and documented in QAI...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 42042 Based on observations, interview, and document review, it was determined the facility failed to ensure an appropriate dress code was maintained for infection control practices. The findings include: During observations on the treatment floor on 09/04/24, the surveyor observed Staff Member #8 performing dialysis care with nails extending approximately one inch beyond fingers. The surveyor met with Staff Member #1 in the afternoon of 09/05/24 to disseminate the findings, and was provided the facility policy titled, “Employee Dress Code” (with effective date of 06/18/21). Under “Patient Care/Lab Environments” section of page two, the policy stated, in part, the following: To ensure employees maintain a work environment that adheres to safety and infection control protocols, the following applies: Fingernails must be clean and no more than one-quarter of an inch beyond the tip of the finger” [sic]. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 42042 Based on ten (10) infection control observations, interview, and document review, it was determined the facility failed to ensure that hand hygiene was performed in between glove changes. The findings include: The surveyors conducted observations of the treatment floor on 09/04/24 from 10:02 AM until 1:10 PM. While observing the discontinuation of dialysis care with a central venous catheter (CVC) on 09/04/24 at 11:25 AM, the surveyor observed Staff Member #10 failing to perform hand hygiene prior to donning clean gloves at hemodialysis station #8. Additionally, the surveyor observed Staff Member #9 preparing and administering Heparin parenteral/intravenous (IV) medication to a patient located at hemodialysis station #11 on 09/04/24 at approximately 12:00 PM. Following preparation, the surveyor observed the staff member enter the patient’s treatment area to don clean gloves without performing hand hygiene prior to administering the IV medication. 46466 On September 4, 2024 at 10:15 AM, Staff Member #9 was observed removing gloves after caring for a patient at station #3. Staff Member #9 began to remove their gloves while walking towards the trash can. After disposing of the gloves, Staff Member #9 began to rub their hands together as if they had just placed hand sanitizer on their hands beside the trash can. After this observation, the surveyor inspected the area around the trash can and found that there was no hand sanitizer bottle located near the trash can. Also, there was no hand sanitizer bottle on station #3. At 10:22 AM, Staff Member #9 was observed removing their gloves. Staff Member #9 did not hand sanitize after removing their gloves and donning new gloves. At 10:25 AM, Staff Member #9 removed their contaminated gloves in the trash can and started to rub their hands together as though they had used hand sanitizer. Again, there was no hand sanitizer located near the trash can where Staff Member #9 disposed of their gloves. At 10:35 AM, Staff Member was observed removing their gloves and did not hand sanitize prior to donning new gloves. At 10:38 AM, Staff Member #9 was observed touching the contaminated dialysis station at station #4 while wearing gloves. With the same gloves, Staff Member #9 walked to a clean sink, picked up a clean cloth, soaked in it the bleach solution and walked back to station #4 and began to disinfect the machine. Staff Member #9 never removed the contaminated gloves before touching the clean bleach solution and wipes. At 10:45 AM, while wearing gloves, Staff Member #9 touched the screen of station #4. With the same gloves, Staff Member #9 walked over to station #3 and touched the screen. Staff Member #9 left station #3 and went to the treatment floor door and brought a patient to station #3 and began patient care. Staff Member #3 never removed their gloves after touching each station and beginning patient care. At 10:50 AM, Staff Member #9 was observed cannulating a patient at station #3. After cannulation, Staff Member #9 walked over to the container of clean clamps, inserted the contaminated gloved hand into the container, pulled out a clean clamp and went back to station #3 and placed it at the station. Staff Member #9 did not remove their contaminated gloves before placing their hand into the clean container. At 11:00 AM, the surveyor discussed the observations with Staff Member #1. Staff Member #1 removed Staff Member #9 from the treatment floor temporarily. Staff Member #9 returned to the treatment floor approximately five (5) minutes later and continued to perform patient care. A review of the facility’s policy “Hand Hygiene”, published 11/6/23, stated in part: “...Hands will be...Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water...Immediately after removing gloves...Alcohol Based Hand Rubs...installed on the side of each dialysis machine...”. A review of the facility’s policy “Personal Protective Equipment”, published 11/6/23, stated in part: “...Always perform hand hygiene after glove removal. Avoid touching surfaces with gloved hands that will be touched with ungloved hands...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 42042 Based on observations, interview, and document review, it was determined the facility failed to ensure that bleach for disinfecting were maintained according to facility policy. The findings include: While conducting treatment floor observations on 09/04/24 at 10:45 AM, the surveyor identified two separate “1:100” bleach containers (Bleach Container #1 and #2) located on both sides of the nursing station. Bleach Container #1 had a label indicating it was prepared on 08/23/24, while Bleach Container #2 did not have any label indicating the date and time in which it was prepared. On 09/05/24 at 2:46 PM, the surveyor met with both Staff Member #1 and Staff Member #6 to share the aforementioned observations. Both staff members demonstrated understanding of findings without additional response. 46466 Based on four (4) infection control observations and facility document review, the facility staff failed to ensure that clean areas were not contaminated with dirty supplies. The findings include: On September 4, 2024 at 10:00 AM, the surveyor observed a used pair of dirty, crumpled gloves and a used face shield with the name of a staff member who was not working in the facility on the day laying on the desk in the nurses station. At 10:38 AM, Staff Member #9 was observed touching the contaminated dialysis station at station #4 while wearing gloves. With the same gloves, Staff Member #9 walked to a clean sink, picked up a clean cloth, soaked in it the bleach solution and walked back to station #4 and began to disinfect the machine. Staff Member #9 never removed the contaminated gloves before touching the clean bleach solution and wipes. At 10:50 AM, Staff Member #9 was observed cannulating a patient at station #3. After cannulation, Staff Member #9 walked over to the container of clean clamps, inserted the contaminated gloved hand into the container, pulled out a clean clamp and went back to station #3 and placed it at the station. Staff Member #9 did not remove their contaminated gloves before placing their hand into the clean container. On September 4, 2024 at 11:10 AM, a used gown was observed laying over a clean clamps container and across the nurses station. Staff Member #9 returned the treatment floor and was observed picking up used gown and placing it back on. A review of the facility’s policy, “Dialysis Precautions”, published 1/4/12, documented in part: “...Clean Versus Dirty Areas: Clean area: An area designated for clean and unused equipment, supplies and medications. 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...”. A review of the facility’s policy, “Mixing Bleach”, published 6/5/24, documented in part: “...Procedure...4. Label opaque container with “Bleach Solution”, strength of solution, date and time prepared, and preparer’s initials...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 42042 Based on observations, interview, and document review, it was determined the facility failed to properly clean and disinfect the dialysis station following treatment for two (2) of three (3) observations. The findings include: On 09/04/24 at 11:34 AM, the surveyor observed Staff Member #10 using a disinfectant-soaked wipe to clean hemodialysis station #8. The surveyor observed that the staff member omitted cleaning of the dialysate hoses, Hansen connectors, and internal and external surface areas of the prime waste container. 46466 On September 4, 2024 at 10:40 AM, Staff Member #9 was observed disinfecting patient station #4. Staff Member #9 did not disinfect the blood pressure cuff and did not place the chair in Trendelenburg position to disinfect the seat or the foot rest. A review of the facility’s policy “Cleaning and Disinfecting the Dialysis Station”, published 9/5/23, documented in part: “...Procedure...3. Use a cloth wetted with 1:100 bleach solution or EPA-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV pole, B/P cuff, hand sanitizer dispenser and holder, chaise wall behind chair). Place the chair in Trendelenburg position and open side panels if chair has swing open sides so all surfaces of the chair are accessible...”. On 09/05/24 at 2:46 PM, the surveyor met with both Staff Member #1 and Staff Member #6 to share the aforementioned observations. Both staff members demonstrated understanding of findings without additional response.”

“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: 46466 Based on observations, interviews and facility document review, it was determined the facility staff failed to perform monthly Hepatitis B testing on one (1) of six (6) patient records sampled. The findings include: On September 5, 2024 at 2:40 PM, a review of Patient #5’s medical record was conducted. Patient #5’s was admitted to the facility on 5/22/24. On 5/22/24, Patient #5’s Hepatitis B surface antigen and Hepatitis B antibody testings revealed that Patient #5 was negative for both the virus and the antibodies. These results indicated that Patient #5 was susceptible to the Hepatitis B virus. Patient #5 not have any further testing for the Hepatitis b virus after 5/22/24. Patient #5 was not a candidate for the Hepatitis B vaccine due to an allergy to the vaccine. A review of the facility’s policy “Patient Hepatitis B Testing Requirements”, published 2/7/22, documented: “...HBV Patient Testing: Hepatitis B laboratory testing is required for all patients based upon immunity status. Susceptible...HBSAg: Negative, Anti-HBs: less than 10 mlU/ml, Anti-HBc “total”: negative...Monthly Testing...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 46466 Based on facility document review, it was determined the facility failed to conduct monthly infection control (IC) audits on facility staff members. The findings include: On September 4, 2024 at approximately 1:45 PM, a review of the facility’s “Clinic Audit Checklist” for Infection Prevention was conducted. The checklist was missing documentation that infection control audits were completed in February, 2024, March, 2024, July, 2024 and August, 2024. On September 5, 2024, Staff Members #1 was unable to provide evidence to support that infection control audits were conducted on the missing months. A review of the facility’s policy “Infection Control Overview”, published 5/2/22, documented in part: “...Mandatory Components of Program...Adherence to standard and dialysis precautions, mechanism to evaluate the effectiveness of the program and take corrective action...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42042 Based on observations, interview, and document review, it was determined the facility failed to properly label opened multi-dose medication vials and discard expired medications The findings include: On 09/04/24 at 10:25 AM, the surveyor inspected the contents of the medication storage refrigerator located adjacent to the nurse’s station. Upon inspection, the surveyor identified the following medications inappropriately stored according to infection control guidelines: Epogen, 20,000 U/mL multi-dose medication vial [Lot # 1157188], opened without label indicating the date and time opened with staff responsible. Pneumococcal Vaccine (Pneumovax 23), single dose vial [W025084], Quantity: 7 vials, Expiration Date: 08/12/2024. Daptomycin, 500 mg (milligram), single dose vial [F7E0109A1], Quantity:19 vials, Expiration Date: 01/31/2024. 46466 A review of the facility’s policy “Medication Preparation and Administration”, published 2/6/23, stated in part: “Labeling Vials: When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT...must place the date and time the vial was opened on the medication label along with their initials...Expiration dates for all stored medications are to be monitored on a monthly basis. -Expired medications are to be discarded...Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 46466 Based on observation and facility document review, it was determined that the facility failed to ensure that test strips were disposed of on or after the expiration date. The findings include: On September 4, 2024 at 10:05 AM, one (1) bottle of minncare test strips was found on a clean sink on the treatment floor. The bottom of the bottle indicated that the strips expired on 6/12/2024. According to the manufacturers directions found at (https://www.evoqua.com/en/evoqua/parts--consumables/chemicals-chemical-feeders-and-parts/chemicals/disinfectants/minncare-residual-test-strips/?srsltid=AfmBOor26ax2uGRO6JUSW2gzFYDK0IB-Taa0Z1eZbpxz_UVqOEGsp6-q), “Both the Minncare 1% TS and the Minncare Residual Test Strips may be used up to and including the last day of the month indicated by the expiration printed on the container even after opening”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 46466 Based on observations and facility document review, it was determined the facility staff failed to ensure a secure and safe environment for all staff, visitors and patients while on facility property. The findings include: On September 4, 2024 at 9:30 AM, the surveyors entered the facility to find the treatment floor door unlatched and insecure. The surveyor was able to open the door and obtain entry to the treatment floor. A review of the facility’s policy “Physical Security and Facility Access”, published 9/5/23, documented in part: “...Physical Security...Doors from the waiting area to the treatment area should remain closed and locked at all times while still allowing emergency access/exit. NO person other than the patients scheduled for treatment and authorized staff are to be admitted into the treatment area while dialysis is taking place...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42042 Based on observations, interview, and document review, it was determined the facility failed to ensure that patient access sites were uncovered and visible throughout dialysis treatment. The findings include: On 09/04/24 at 10:55 AM, the surveyor observed three patients receiving dialysis treatments with access sites covered located at Hemodialysis Stations # (1, 9, 12). The surveyor continued to conduct observations until 09/04/24 at 1:10 PM, and confirmed the aforementioned accesses remained covered without staff intervention. On 09/05/24 at 2:46 PM, the surveyor met with both Staff Member #1 and Staff Member #6 to share the aforementioned observations. Both staff members demonstrated understanding of findings without additional response. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“PR-RECEIVE UNDERSTANDABLE INFORMATION CFR(s): 494.70(a)(2) The patient has the right to- (2) Receive all information in a way that he or she can understand; This Standard is not met as evidenced by: 46466 Based on interviews and medical document review, it was determined the facility staff failed to provide a patient with information in a way that they could understand. The findings include: On September 4 and September 5, 2024, a review of Patient #5’s medical record was conducted. Patient #5’s medical chart indicated that staff utilized a Spanish translator when communicating with Patient #5. In Patient #5’s paper chart, there was a consent form for the hepatitis B vaccine written in English with a “Sign here” sticker indicating where the patient should sign. Patient #5’s signature was located on the line consenting for the vaccine. Patient #5’s medical chart also documented that Patient #5 had an allergy to the Hepatitis B vaccine. Additionally, medical records from a hospitalization dated 5/8/24 documented Patient #5’s allergy prior to their admission to the facility on 5/22/24. On September 5, 2024 at 1:10 PM, Staff Member #1 confirmed that the signed Hepatitis B vaccine consent form should not have been in Patient #5’s medical chart. A review of the facility’s policy “Patient Vaccination for Hepatitis B”, published 2/7/22, documented in part: “...Documentation: Document...vaccine declinations in the patients’ electronic medical record. Reasons for vaccine declination include...Medical Contraindication (e.g., allergies, other)...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 42042 Based on observations, interview, and document review, it was determined the facility failed to conspicuously post all required signage to include the contact information for the State Agency (SA). The findings include: On 09/04/24 at approximately 9:45 AM, the surveyors made observations of the facility lobby and was unable to identify any signage indicating how patients and/or staff could contact the SA for complaints or concerns. In the evening of 09/04/24, the surveyor discussed the concern with with both Staff Member #1 and Staff Member #6. The surveyor accompanied both staff members to the lobby to verify that no SA contact information (i.e. phone number, mailing address) was posted and available. The surveyor informed both staff members that the aforementioned signage was required to be plainly posted. Both surveyors notified Staff Member #1 and Staff Member #6 to share the aforementioned observations. Both staff members verbalized understanding without additional response. 46466”

“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: 42042 Based on clinical record and facility document review, it was determined the facility staff failed to ensure patients were monitored during their treatments within forty-five (45) minutes; and failed to ensure that the Registered Nurse (RN) assessed patients within one (1) hour of dialysis treatment. The findings include: On 09/04/24 and 09/05/24, the surveyors conducted medical record review of Patient # (1-6) to include the most recent two weeks’ worth of treatment flowsheets. While reviewing Patient #4’s medical record in the morning of 09/05/24, the surveyor identified two of six dialysis treatments in which nursing assessments were not conducted within one hour of treatment initiation. 08/21/24: Patient #4’s treatment was initiated at 4:10 PM. Nursing assessment not conducted until 5:41 PM. 08/23/24: Patient #4’s treatment was initiated at 4:17 PM. Nursing assessment not conducted until 5:27 PM. During medical record review on 09/05/24, the surveyor identified the following treatments in which Patient #4’s vital signs were not monitored every forty-five (45) minutes as required during dialysis treatment: 08/26/24: No vital signs were documented between [5:37 PM through 6:33 PM]. 08/28/24: Last set of vital signs documented was at 6:34 PM. The patient continued to receive dialysis treatment until 8:24 PM. 08/30/24: No vital signs were documented between [1:33 PM through 2:36 PM]. 46466 A review of treatment records for the sampled patients revealed the following: Patient #5: Six (6) treatment records were reviewed from 8/21/24 to 9/2/24. On 8/23/24, the treatment record evidenced treatment monitoring at 3:33 PM. It was not completed again until 4:34 PM. The treatment began at 2:53 PM, the RN assessment was documented at 4:18 PM. On 8/26/24, the treatment began at 2:43 PM, the RN evaluation was documented at 4:38 PM. On 8/28/24, the treatment record evidenced treatment monitoring at 5:34 PM. It was not completed again until 6:39 PM. The treatment began at 2:37 PM, the RN assessment was documented at 4:52 PM. On 8/30/24, the treatment record evidenced treatment monitoring at 2:37 PM. It was not completed again until 4:01 PM. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...During treatment: - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations... A review of the facility’s policy “Nursing Supervision and Delegation”, published 11/6/23, stated in part: “...Non-Delegated Tasks...Assessment of each patient preferably within an hour (or according to state requirements) of treatment initiation in the clinic setting...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 42042 46466 Based on medical record and facility document review, it was determined the facility staff failed to follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) and/or DFR (dialysate flow rate) for two (2) of six (6) dialysis patients included in the sample. The findings included: Patient #2: The surveyor reviewed six (6) dialysis treatment records from 7/10/24 to 8/30/24. The treatment records evidenced an order for a BFR of 500. The treatment sheets evidenced the following: On 7/15/24, the BFR was documented as 450. On 7/17/24, the BFR was documented as 450. On 7/19/24, the BFR was documented as 450. Patient #2’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. Patient #5: The surveyor reviewed six (6) dialysis treatment records from 8/21/24 to 9/2/24. The treatment records evidenced an order for a BFR of 450 and DFR of 800. The treatment sheets evidenced the following: On 8/23/24, the BFR was documented as 400. On 8/26/24, the DFR was documented as 500. On 8/30/24, the BFR was documented as 410. Patient #5’s clinical record failed to contain evidence of documentation explaining why the BFR and/or DFR were not being administered as prescribed. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...3. Machine Parameters and Extracorpeal 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”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 46466 Based on one (1) infection control observation and facility policy review, it was determined the facility staff failed to use aseptic technique when accessing an arteriovenous (AV) fistula/graft. The findings included: On September 4, 2024 at 10:20 AM, the surveyor observed a Staff Member #9 preparing to access an AV site on a patient at station #2. Staff Member #9 wiped the patient’s AV site with antiseptic, palpated the access site and inserted the cannulation needle without reapplying antiseptic to the AV site after palpating. A review of the facility’s policy “Access Assessment and Cannulation”, published 5/6/24 documented in part: ...Skin Disinfection...Step 2. Perform skin antisepsis on one site at a time, allow to dry and them {sic} cannulate. Do not touch cannulation sites after skin disinfection...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“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: 46466 Based on medical record review and facility document review, it was determined that facility staff failed to ensure the Plan of Care (POC) was signed by the patient for one (1) of four (4) patient records sampled. The findings included: Medical record review on September 5, 2024 evidenced that one (1) of four (4) patient records sampled had a POC that did not contain a signature from the patient. Patient #2- POC (dated 6/26/24) failed to document Patient #2’s signature or Patient #2’s refusal to sign. On September 5, 2024, a signed copy of Patient #2’s POC dated 6/26/24 was requested of Staff Member #1, however, the signed POC was not provided to the surveyors prior to the exit conference. A review of the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care”, published 7/3/23, stated in part: “...Comprehensive Assessment Participation and Plan of Care Review...- The patient must sign the plan of care meant to acknowledge the information in the plan. If the patient chooses not to sign their plan of care, the reason for the refusal must be documented in the patient’s medical record...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 46466 Based on interview and medical record review, it was determined the facility staff failed to update a patient’s Plan of Care (POC) to reflect the patient’s current condition. The findings include: On September 5, 2024, a review of Patient #5’s POC dated 8/28/24, revealed that the area of focus for vaccination/immunization status was opened on 6/10/2024. The due date for the goal to vaccinate the patient was dated 9/30/24. The interventions listed was to ensure that the patient was current with flu, Hepatitis B and pneumonia vaccines and was dated 6/10/24 as “in progress”. Patient #5’s medical record indicated that the patient had an allergy to Hepatitis B vaccine. This was documented on a hospitalization record dated 5/8/24, which was prior to Patient #5’s admission to the facility on 5/22/24. The POC did not document a declination for the hepatitis vaccine or that Patient #5 had an allergy. On September 5, 2024 at 1:10 PM, Staff Member #1 confirmed that the goal should have been closed. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 46466 Based on interviews, medical record review and facility document review, it was determined the facility staff failed to report and document patient related safety events. The findings include: On September 5, 2024, a review of Patient #5’s medical record was reviewed. The medical record documented on August 21, 2024 at 7:04 PM “...Pt got sick, feeling cold, with elevated temp. MD notified and ordered 2 sets of blood culture: pt condition continued, MD called to report pt condition, and get permission to send to ER. 911 called, pt sent to ER, MD has not returned call at this time”. On September 4, 2024 at 12:30 PM, a review a the facility’s “Adverse Event” report was reviewed. There were two (2) events documented in the past six (6) months. The two (2) events did not include Patient #5’s event on August 21, 2024. On September 5, 2024 at 1:25 PM, a review of the facility’s “Patient Safety” report for the last six (6) months was reviewed. There were only two (2) events listed on this report and again, Patient #5’s event was not listed on the report. On September 5, 2024 at 1:25 PM, an interview was conducted with Staff Member #1. Staff Member #1 stated that Patient #5’s event should have been documented on the “Patient Safety” report. A review of the facility’s policy “Patient Safety Event Reporting and Documentation”, published 2/6/23, stated in part: “...Policy: When a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event as noted in this policy. Staff are responsible for timely completion of these policy requirements...”. The findings were discussed with Staff Members #1, #5 #6, and #11 at the exit conference on September 5, 2024 at 3:00 PM.”