Davita Chatham Dialysis

“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: 21229 Based on observation, staff interview, and facility policy review, it was determined the facility failed to 1. Ensure all staff members who were assigned the responsibility of mixing the 1:100 (one to one-hundred) bleach concentration for cleaning and disinfection of treatment stations were proficient and 2. Ensure the thorough cleaning and disinfection of the dialysis treatment stations for two (2) of four (4) observations. The findings include: 1. On June 16, 2025 at 9:15 a.m., the surveyor observed three (3) containers labeled 1:100 bleach - expiration date 6/12/15. The surveyor inquired with Staff Member #5 (Patient Care Technician) as to when the bleach water was prepared and when it expired. Staff Member #5 examined the label and then went to Staff Member #4 and asked about the mixing of the bleach. Staff Member # 5 returned to the surveyor and indicated that staff Member #4 had prepared the solution earlier that morning as those were the staff member’s initials on the label and that “(Staff Member) forgot to change the date”. The surveyor was informed that Staff Member #4 was “still in training”. The surveyor expressed concern related to the bleach mixture with the incorrect date. Staff Member #4 proceeded to empty all the containers and refill them. The surveyor observed the staff member to be filling the containers at the dirty sink area and was not measuring the amount of water in the container. The surveyor inquired as to whether there was a mark or identifier on the container to tell the staff member exactly how much water to place in the bin in order to achieve the correct concentration of the bleach mixture. Staff Member #4 stated “I don’t know. I will ask”. Staff Member #4 went to Staff Member #8 (Patient Care Technician - PCT) and the PCT gave the staff member a graduated measuring container and explained to Staff Member #4 how much water they should put in the container along with the amount of bleach. Staff Member #4 was also informed that the “clean” containers should not be placed in, and filled at the identified “dirty sink”. Staff Member #4 refilled the containers and added the bleach and marked the containers with the date and their initials. Staff Member #5 explained the bleach solution was only used on the day it is prepared. The facility policy “Preparation of One to One Hundred (1:100) Bleach Solution” was reviewed and evidenced, in part: “...Materials required: Container of 5.25-6.25% Environmental Protection Agency (EPA) registered sodium hypochlorite (Household bleach), water, Plastic 1000ml (one thousand milliliter - 1 liter) graduated cylinder calibrated in 10ml (ten milliliter) increments dedicated for bleach mixing only..5...Remove the previously applied mixing label including expiration date, time and initials...7. Fill the graduated cylinder approximately 1/2/ full (500ml) with water. 8. Carefully add 10ml of household bleach to the cylinder. 9 Fill the graduated cylinder to the 1000 ml (1 liter) mark with water. 10. Carefully pour the contents of the graduated cylinder into the disinfectant container...12. With indelible marking pen and label, label container with expiration date, time and initials. The solution is good for 24 (twenty-four) hours only...” 2. The surveyor observed Staff Member #4 cleaning the treatment station 14 on June 16, 2025 at 10:40 a.m. The surveyor observed the staff member did not clean the entire IV pole (attached to dialysis machine) nor did the staff member open and clean the dialysis cartridge (kidney) clamp, the Hanson connector hoses and did not empty, rinse nor wipe out the prime bucket. Staff Member #8 was cleaning the wall box behind the station and when (Staff Member #8) stood up they observed liquid in the prime bucket, removed the bucket, emptied it and wiped it out, but did not wipe down the side of the machine before replacing the bucket. At 11:05 a.m., the surveyor again observed Staff Member #4 cleaning station 16. The staff member did not clean the IV pole, the dialyzer clamp, the sides of the machine nor the wall box. The staff member, after performing hand hygiene, retrieved clean supplies to prepare for the next patient, bringing them to the treatment station and lying them in the chair seat. The Staff Member was observed to return to the bleach container, retrieve a bleach cloth and proceed to clean the prime bucket, after which they removed gloves, sanitized and began to set up the machine. The facility policy “Infection Control for Dialysis Centers” evidenced, in part: “...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with patient or their belongings...1. the wall box, drain and water supply lines...priming containers are to be emptied prior to disinfection...” The surveyor discussed the observations with Staff Members #1 (Manager of Clinical Services) and #2 (Interim Facility Administrator) on June 16, 2025, at approximately 11:30 a.m., The surveyor also discussed the concern that whether a staff member “in training” was being adequately precepted while performing tasks on the treatment unit. The Staff Members (1 and 2) acknowledged the concern.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 45736 Based on personnel file review, facility policy review and interview, it was determined the facility failed to verify hepatitis B immunity in one (1) of ten (10) facility staff members. The findings include: On June 16, 2025 at approximately 2:00 PM, the surveyor reviewed the personnel files for ten (10) facility staff members. A review of the personnel file for Staff Member #17, who was hired on April 7, 2025, revealed they did not have documentation of screening for hepatitis B surface antigen or evidence of immunity to hepatitis B. A facility policy Teammate Hepatitis B Monitoring and Follow-Up Guidance, last revision April, 2024, revealed, in part: “...1. New teammates who are not able to provide documentation of hepatitis B surface antibodies..from any time in the past...will be screened for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results...”. During an interview on June 16, 2025 at 2:15 PM with Staff Member #1, they confirmed that the facility did not have Staff Member #17’s documentation of Hepatitis B status and that this should be completed within ten (10) days.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 45736 Based on personnel file review, facility document review and interview, it was determined the facility failed to provide documentation for two (2) of ten (10) staff member’s infection control training. The findings include: On June 16, 2025 at 2:00 PM, a review of ten (10) personnel records was conducted. Two (2) of ten (10) staff members did not have documentation of current infection control training. Staff Member #14 (hire date December 2, 2023) and #17 (hire date April 7, 2025). A facility policy, Training Programs for New Patient Care Provider Teammates, last revision April 2025, was reviewed and did not contain specific details on initial and annual infection control training for staff members. During an interview the morning of June 17, 2025, with Staff Member #2, they indicated that infection control training is conducted within their RISE training curriculum and infection control training should be conducted during orientation. When the surveyor asked if it was reasonable that Staff Member #17, who was still in orientation should have completed their infection control training, Staff Member #2 said yes.”

“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: 21229 Based on observation, staff interview, and facility policy review, it was determined the facility failed to ensure, when opened or prepared, medications were properly labeled. The findings include: During observations on the treatment unit, the surveyor observed the following in the area designated as the “medication preparation area”: One multi-dose vial of Heparin (blood thinner) 30,000u/30 ml (thirty thousand units per thirty milliliters) was opened and not dated as to when opened and not initialed by the staff member opening the vial. There were multiple syringes prepared with medications for administration bearing labels of patient names, drug and dose. The medications were not initialed nor included the time the staff member (Registered Nurse) prepared the medications. The medications were as follows: Four (4) syringes identified as Venofer (a medication used to treat iron deficiency anemia), One (1) syringe identified as Micera (a medication used to treat anemia), and three (3) syringes identified as heparin (a blood thinner). On June 16, 2025 at 11:05 a.m., the surveyor inquired as to the facility policy regarding medication preparation and labeling. Staff Member #3 (Registered Nurse) indicated medications, once drawn up in the syringe should be labeled with the patient name, date, drug, dose as well as the time the medication was drawn up and the nurse’s initials. “Yes, we are supposed to initial and put the time when we draw up the medications...the bottle of heparin should also be marked as to when it was opened, but we go through so many in a day, sometimes we only mark the one at the end of the day if there is any medication left in the vial that we can use for the next treatment day...” The facility policy “Medication Policy” evidenced,in part: “...20... If medications are not administered immediately or are to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medications...29...Each vial is labeled with the initials of the person opening the vial and the expiration date...” On June 19, 2025 at approximately 11:30 a.m., the surveyor discussed the observation with Staff Members #1 (Manager of Clinical Services) and Staff Member #2 (Interim Facility Administrator).”

“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: 45736 Based on personnel file review, facility document review and interview, it was determined the facility failed to ensure that color blindness testing was performed on four (4) of ten (10) facility staff members. The findings include: On June 16, 2025 at 2:00 PM, a review of ten (10) personnel records was conducted. There was no documentation of color blindness testing being completed on Staff Members #14 (hire date December 2, 2023), #15 (hire date March 17, 2025), #16 (hire date November 18, 2024) and #17 (hire date April 7, 2025). A facility policy, Color Vision Evaluation, last revision October 2017, was reviewed and revealed, in part, “...1...Color blindness testing is performed at time of hire...3. The Facility Administrator/Program Manager/designee is responsible for assuring that the appropriate teammates are evaluated for ability to see color...”. During an interview the afternoon of June 16, 2025, with Staff Member #1, they confirmed that the personnel records for the above staff members did not contain evidence that a color blindness test was performed. Staff Member #1 conducted color blindness testing on the four staff members the afternoon of June 16, 2025 and all staff members passed the test.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 45736 Based on personnel file review, facility document review and interview, it was determined the facility failed to provide documentation for one (1) of ten (10) staff member’s water and dialysate training. The findings include: On June 16, 2025 at 2:00 PM, a review of ten (10) personnel records was conducted. One (1) of ten (10) staff members did not have documentation of current training and competencies on water and dialysate. Staff Member #14 (hire date December 2, 2023). A facility policy, Training Programs for New Patient Care Provider Teammates, last revision April 2025, was reviewed and did not contain specific details on annual water and dialysate training for staff members. During an interview the morning of June 17, 2025, with Staff Member #2, they indicated that water and dialysate training is conducted within their RISE training curriculum and this training should be conducted during orientation and annually.”

“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: 21229 Based on clinical record review, staff interview and facility policy review, it was determined the facility failed to ensure one (1) of 5 (five) patients, Patient #5 had documentation they had been informed of the risks of discontinuing their dialysis treatment prior to the prescribed time set by their physician. The findings include: Patient #5 was admitted to the facility on June 14, 2023. The patient was ordered dialysis treatment three (3) days a week for 240 minutes (4 hours). Review of the treatment records for June 2, June 4, June 6, and June 11, 2025 revealed Patient #5 had discontinued their treatment early (average time one hour early). The treatment records for each date documented “Close Treatment Reason: Patient Choice (AMA [against medical advice], feels unwell/cramping, patient behavioral issue). None of the treatment records documented that the patient had any complaints during treatment indicating they were ill or there was issue. There was just the documentation “treatment terminated”. The patient had been identified as having concerns related to adequacy (getting enough dialysis) according to the latest lab results. The surveyor was unable to locate in the clinical record any documentation of the patient having been notified of the risks each time they chose to end treatment early. The surveyor requested the assistance of Staff Members #1 and 2 (Manager and Interim Administrator) on June 16, 2025 at approximately 1:30 p.m. to locate documentation of the patient signing the “Against Medical Advice” document. Staff Member #2 stated there were no documents found for the dates listed. The facility policy “Prescribed Treatment Time Not Met” was reviewed and evidenced, in part: “...4. A completed copy of the Early Termination of Treatment Against Medical Advice form will be kept in the patient’s health record...6. The Facility Administrator?Designee will verify that all shortened treatments are recorded and trended...and reviewed and discussed at Facility Health Meetings (FHM) as appropriate...””

“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: 21229 Based on observation, staff interview and facility policy review, it was determined the facility failed to ensure aseptic technique when accessing the dialysis access site at the initiation of dialysis treatment for one (1) of four (4) observations. The findings include: On June 16, 2025 at 9 38 a.m., the surveyor observed Staff Member #8 initiating dialysis treatment for the patient at station #13. During the observation, after the Staff Member had thoroughly cleaned and applied antiseptic to the access site, the Staff Member was observed to touch the cleaned insertion site prior to inserting both the arterial and venous needles. The facility policy “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and administration of Heparin Loading Dose” evidenced, in part: “...13. Do Not palpate insertion site once area has been prepped . Once the access site has been prepped, touching it will contaminate the site and possibly allow for introduction of bacteria during cannulation...” On June 19, 2025 at approximately 11:30 a.m., the surveyor discussed the observation with Staff Members #1 (Manager of Clinical Services) and Staff Member #2 (Interim Facility Administrator).”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 45736 Based on personnel file review, facility policy review and interview, it was determined the facility failed to perform initial Tuberculosis (TB) testing on two (2) of ten (10) staff members. The findings include: On June 16, 2025 at approximately 2:00 PM, the surveyor reviewed the personnel files for ten (10) facility staff members. A review of the personnel file for Staff Member #15 (hire date March 17, 2025) and Staff Member #17 (hire date April 7, 2025), did not have documentation of TB testing. A facility policy, Tuberculosis Monitoring and Follow Up, last revision October 2024, revealed, in part, “... 3...c...i. Baseline TST (tuberculin skin test) using a two step Purified Protein Derivative (PPD) Mantoux test (a *second TST repeated one to three weeks after the first, If the initial test is negative. Test results will be recorded on the Teammate Health Monitoring Record...iv. Baseline TST results must be documented and recorded in millimeters within 10 days of employment...” During an interview on June 16, 2025 at 2:15 PM, with Staff Member #1, they indicated the facility did not have Staff Member #15 or #17’s TB testing documentation and that this should be completed during staff onboarding and within 10 days. Based on personnel file review, facility policy review and interview, it was determined the facility failed to provide evidence that staff member’s annual competencies were maintained according to facility policy. The findings include: On June 16, 2025 at approximately 2:00 PM, the surveyor reviewed the personnel files for ten (10) facility staff members. Staff Members #19 (hire date April 25, 2022), and Staff Member #20’s (hire date July 2, 2018) personnel files did not include evidence that their annual competency verification had been performed. Staff Member #19’s last annual competencies were documented as “June 2023” and Staff Member #20’s last annual competencies were documented as February 28, 2024. A facility policy, Training Programs for New Patient Care Provider Teammates, last revision April 2025, was reviewed and did not contain specific details on annual competencies requirements. During an interview with Staff Member #2, the morning of June 17, 2025, they indicated that competencies are conducted annually and this should be documented in staff member personnel files or via the online learning transcript.”