Fresenius Kidney Care Worcester County Dialysis

“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: 10249 Based on observation, and staff interview, the facility failed to ensure that proper infection control practices were followed when personal protective equipment (PPE) came in contact with both clean and dirty items. Findings include: On 2/3/25 at 9:00 A.M., during the flash tour, the surveyor observed 2 hoyer pads, used to transfer patients from their wheel chair to a dialysis chair, hanging from a wall hook. The wall hook was located by station 1. The hoyer pads were overlapping each other. On 2/3/25 at 11:30 A.M., the surveyor observed 3 gowns hanging from separate wall hooks. Two gowns were touching the floor, and a third gown was touching a dialysis chair, that was stored in the area. There were 2 patient’s personal wheelchairs that were pushed up against the wall, preventing staff from hanging their PPE. On 2/3/25 at 1:30 P.M., the surveyor observed 3 gowns hanging from separate wall hooks, however they were touching the floor. On 2/4/25 at 11:00 A.M., the surveyor observed 2 hoyer pads hanging from one wall hook, located by the station 1. The hoyer pads were overlapping each other. During an interview on 2/4/25 at 11:15 A.M., Registered Nurse [RN] #3 said the PPE (gowns) should not be touching the floor, nor should the wheel chairs be placed against the wall, in front of the PPE. RN #3 said she was not aware that the hoyer pads were being stored on the hook and overlapping each other.”

“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: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1) observed, adequately cleaned and disinfected contaminated surfaces within the dialysis station, increasing the risk of cross contamination of blood borne pathogens. Findings Include: Review of the facility policy, titled Cleaning and Disinfection of the Dialysis Station, published November 2020, indicated the following: Definition: *Dialysis Station - Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during the dialysis treatment, patient training, and/or patient clinic visits. *Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as IV pole, BP cuff and hand sanitizer/holder, organizer, chair/bed, Pureflow SL, and individual television and remote. *All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. On 2/3/25 at 9:50 A.M., the surveyor observed CCHT #1 disinfect station 15 for the next patient. He was observed to disinfect the hemodialysis machine and hemodialysis chair using 1:100 bleach soaked pads. CCHT #1 failed to disinfect the countertops located behind the hemodialysis machine and chair. He also failed to disinfect the portable sharps container that was next to the hemodialysis machine. During an interview on 2/3/25 at 10:05 A.M., CCHT #1 said he only cleans the countertops or sharps container if they see debris on it or if the patient’s belongings were on the counter. During an interview on 2/3/25 at 3:00 P.M., the Director of Operations said the counters and sharps container should have been disinfected.”

“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: 10249 Based on observations, staff interview, and facility policy and guide review, the facility failed to ensure that 1 of 2 staff (Certified Clinical Hemodialysis Technician [CCHT] #1) observed failed to follow the procedure of testing for the presence of Total Chlorine in the reverse osmosis (RO) water. Findings include: Review of the facility policy, titled Total Chlorine Testing using RPC Ultra Low Total Chlorine Stripes, published 3/23/23, indicated the following: *Collect a fresh 100 milliliter (ml) sample of water in a plastic sample cup. *Remove one test strip from its foil package and dip it into the sample for 60 seconds. *While dipping the strip, move it back and forth at a constant gentle rate of approximately two, 1-2 inch wide strokes (one forward-one backward) per second. *Remove the strip and shake once, briskly, to remove excess water. *Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a consistent viewing background. *After the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample. The color block that most closely resembles the color of the test strip is the total chlorine level of the sample. *Document results in electronic documentation system or approved paper log. On 2/3/25 at 8:30 A.M., the surveyor observed CCHT #1 perform a Total Chlorine Test with Registered Nurse #1 present to verify. He rinsed the collection cup thoroughly 3 times and obtained a 100 ml sample. CCHT #1 removed a test strip from the package and dipped it into the RO sample, then moved it back and forth for 60 seconds. He removed the test strip from the RO sample and held the strip for 20 seconds. After the 20 seconds, CCHT #1 briskly flicked the excess RO off the test strip, then compared test strip to the color chart. CCHT #1 failed to flick the test strip prior to waiting the 20 seconds for the test strip to develop. During an interview on 2/4/25 at 9:15 A.M., CCHT #1 said it was my error, I should have flicked the strip, then waited 20 seconds.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 44223 Based on record review, interview, and policy review, the facility failed to ensure a change in modality comprehensive interdisciplinary team (IDT) assessment and plan of care was developed within 30 days for 1 Patient (#1), out of a total sample of 7, when the patient changed from Home Hemodialysis (HHD) to In-Center dialysis (ICHD). Findings Include: Review of the facility policy, titled Comprehensive Interdisciplinary Assessment and Plan of Care, dated 7/3/2023, indicated the following: *An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the latter of 30 days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. Patients changing modalities are classified as new patients and must have comprehensive interdisciplinary assessments and plans of care with the same frequency as patients new to dialysis. *The timeline for both the completion of the initial comprehensive assessment and the beginning of implementation of the initial patient plan of care is the latter of 30 days from the date of admission or 13 hemodialysis treatments at the facility. Patient #1 was admitted to the facility in December 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis three times a week. Review of the last comprehensive assessments and corresponding plan of care, developed when the patient was in the home program (completed December 13, 2024), indicated the patient was receiving dialysis at the Dialysis Den (a dedicated space in a skilled nursing facility where patients receive hemodialysis treatments, which is a part of the home dialysis program). Further review of the medical record indicated Patient #1 transferred to In-Center dialysis on December 26, 2024. There was no change in modality comprehensive assessment or plan of care completed by the IDT, as required when a patient changes modalities. During an interview on 2/4/25 at 12:30 P.M., the Director of Operations said there was no change of modality assessment completed. During an interview on 2/4/25 at 1:00 P.M., the Social Worker said she wasn’t aware an assessment needed to be completed, but she would look at the schedule and add the patient to the care plan calendar.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 37349 Based on record review, staff interview, and document review, the facility failed to adjust the dialysis treatment per their potassium (K+) algorithm to achieve and sustain an acceptable potassium level for 1 of 1 applicable patients (#7), out of a total sample of 7 patients. Potassium levels that are too high (Hyperkalemia) or too low (Hypokalemia) can cause health issues, including abnormal heart rhythms. Findings include: Review of the facility Potassium Algorithm, undated, included the following: Goal * To prevent complications of Hyperkalemia * To prevent complications of Hypokalemia Algorithm * If K+ level is less than 6.0 patient to dialyze on a 2.0 K+ bath * If K+ level is 6.0 or greater patient to dialyze on a 1.0 K+ bath * Resume 2.0 K+ bath when weekly K+ falls below 5.0 Patient #7 admitted to the facility in March 2022 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of K+ lab results for Patient #7, included the following: 1/14/25 - 6.0 (per the algorithm patient to dialyze on 1.0 K+ bath as K+ is 6.0 or greater) 1/21/25 - 5.3 (per the algorithm patient to dialyze on 1.0 K+ bath as weekly K+ not below 5.0) 1/28/25 - 5.6 (per the algorithm patient to dialyze on 1.0 K+ bath as weekly K+ not below 5.0) Review of the dialysis treatment order for Patient #7, dated 1/2/25, indicated that the order was for a 2.0 K+ bath. Review of the dialysis treatment sheets for Patient #7 indicated that treatment was run with a 2.0 K + bath for 6 treatments including on 1/16/25, 1/18/25, 1/21/25, 1/23/25, 1/25/25, and 1/28/25, despite the elevated K+ level obtained on 1/14/25. Review of the clinical note, dated 1/29/25, indicated “K 5.6, bath changed to 1K per algorithm.” Review of the dialysis treatment order for Patient #7, dated 1/30/25, indicated the order changed to a 1.0 K+ bath, 16 days after the initial K+ result 6.0 or greater. During an interview on 2/4/25 at 2:05 P.M., Registered Nurse #3 said that when K+ is 6.0 or greater, a patient should use a 1.0 K+ bath until K+ falls below 5.0. During an interview on 2/4/25 at 3:15 P.M., the Director of Operations said that Patient #7 should have been on a 1 K+ bath when the facility received the 6.0 K+ result from 1/14/25. She said the K+ bath change should have happened sooner than it did, and she was not able to find documentation in the medical record why that did not happen.”