Davita Wheaton Dialysis Center

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 44367 Based on inspection of the facility’s emergency evacuation kit, and a review of their policies and procedures, the facility’s administrative staff failed to maintain a current copy of all of the patients’ treatment orders and medication lists. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency evacuation. Patients: All Findings included: Review on 02/03/2025 of the facility’s policy policy 04-07-02 entitled, “ Evacuation Kit” states: “Each evacuation kit should contain a copy of each patient’s treatment orders and medication list.The Facility Administrator (FA) or designee will verify patient information is update and replaced at least monthly.” 1. During inspection of the facility’s two emergency evacuation kits on 02/03/2025 revealed that neither kit contained any patients’ treatment orders or medication lists for any of the facility’s patients. The Charge Nurse and the Facility Administrator were informed of the findings on 02/03/2025.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44367 Based on observations, review of the facility’s policies and procedures and interviews with facility staff, the governing body and the medical director failed to ensure that personal protective equipment (PPE) was worn according to industry (end stage renal disease) standards. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to all patients, staff members, and visitors. Findings include: Review on 01/30/2025 of the facility’s policy #1-05-01, entitled “Infection Control For Dialysis Facilities” page 2 number 5 states, “An appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care area.” Page 2 number 6 states, “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physicians (NPP) and visitors when in the treatment area.” On 01/30/2025 at 11:22 a.m. during observation of the clinical treatment area, the surveyor noted a visitor was sitting in very close proximity to the patient and the Patient Care Technician (PCT) during the treatment initiation process at station #17. The visitor was sitting approximately 12 inches from the patient’s access while the PCT was cannulating the access. The Facility Administrator was informed of the findings on 01/30/2025”

“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: 44367 Based on clinical observations, a review of the dialysis water room logs, a review of the facility’s policies and procedures, and interviews with the clinical and biomedical staff, the governing body failed to ensure that the clinical staff followed procedure when mixing Dry Acid and cleaning the walboxes. This failure placed all patient at potential risk for exposure endotoxins and infectious diseases. Findings included: Review on 01/30/2025 of the manufactures manual entitled “Dry Acid Dissolution Unit 135 Gallons (500 Liters)”... page 35 states”The micron filter should be changed under the following conditions: 1. After mixing 6 batches of Dry Acid concentrate. 2. When the Dry Acid Dissolution (DADU) requires disinfection.” Review on 01/30/2025 of the facility’s procedure 2-07-04D entitled, “Granuflo (132 Gallon) Batch Record” revealed that the Micron filter attached to the acid dissolution tank is to be replaced “after 6 batches” of Granuflo Dry Acid has been mixed. Inspection of the facility’s water room on 01/30/2025 revealed the following: 1. The surveyor noted that the Micron filter attached to the acid dissolution tank, was completely black with no viability. Interview with the Biomedical Technician revealed that a micron filter is white and the clear liquid is visible even after multiple uses, so after 6 batches there will be some discoloration but visibility should remain. According to Biomed, he/she has had many conversations with the clinical staff regarding changing the micron filter after 6 batches, but the staff has not complied. The surveyor requested documentation from Biomed regarding staff education on the micron filter; However, Biomed stated that the provided education was not documented. According to the documentation for the mixing process of Granuflo Dry Acid completed on 01/18/2025, the micron filter was at batch number 6. The Granuflo Batch Production Record completed on 01/23/2025, stated that the filter was at batch number 1, but there was no date provided as required in the section labeled “last Date 1 Micron Filter Installed.” The Biomed Technician corroborated that the Micron Filter attached to the Acid Dissolution tank has not been changed every 6 batches as required. 2. The Acid Dissolution Tank had a build up of brownish and white colored substance over the entire surface. 3. The drain next to the carbon tank was completely covered in a brownish black substance. The substance was also covering the base of the pipe over the drain. Review on 01/31/2025 of the facility’s policy 1-05-01 entitled, “Infection Control for Dialysis Facilities” states that, “At the end of each treatment, the dialysis station will be cleaned and disinfected...1. The Wall Box, Drain and Water supply lines are considered part of the dialysis delivery system.” 1. During observation of the clinical treatment area on 01/31/2025 at 10:44 a.m., the surveyor observed a approximately 8 inch by 2 inch black colored area on the surface of the wall box at station #15. The Facility Administrator was informed of the findings on 01/30/2025 and 01/31/2025.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #4 and #5 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review on 01/31/2025 of the facility’s policy 1-04-02B, “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” page 2, “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason”; Page 6 number 16 states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...” Page 4 Number 8 states, “clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds...Then wait 60 seconds for air dry time.” 1. During observation of the clinical treatment area on 01/31/2025 at 10:53 a.m., during initiation of treatment of a CVC patient at station #20, Staff #4 removed both caps at the same time exposing the hubs. Staff #4 cleaned the arterial hub for only 5 seconds. Staff #4 did change gloves per policy throughout the process; However, Staff #4 did not perform hand hygiene after removing gloves and before placing new gloves. 2. During observation of the clinical treatment area on 01/31/2025 at 11:33 a.m., during the treatment initiation process of a CVC patient at station #13, after cleaning exit site Staff #5 allowed the site to dry for only 20 seconds before placing a new dressing. The Clinical Specialist and the Facility Administrator were informed of the findings on 01/31/2025.”

“PR-CAN HAVE ADVANCE DIR,TOLD FAC AD P&P CFR(s): 494.70(a)(6) The patient has the right to- (6) Be informed about his or her right to execute advance directives, and the facility ’ s policy regarding advance directives; This Standard is not met as evidenced by: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patients were given information about creating an advance directive in a prompt manner. This failure denied the patients their rights to formulate treatment decisions that served their end of life needs. Patients: #3 and #6 Findings included: Review on 02/03/2025 of the facility’s policy 3-02-19 “Advanced Directives and DNR Policy” revealed “The Patients’ Rights and Responsibilities document, presented to the patient at the initiation of treatment, will advise the patient of his/her right to execute an Advance Directive, and of DaVita’s policy that properly executed and documented Advance Directives will be honored and carried out in DaVita facilities.” A review of the medical records on 02/03/2025 revealed that two (2) out of ten (10) or 20% of the selected patients selected did not have an Advance Directive acknowledgement form in their chart. 1. Patient #3 was admitted on 03/14/2017. An Advanced Directive acknowledgement form was not found in Patient #3’s paper or electronic chart. 2. Patient #6 was admitted on 12/15/2017. An Advanced Directive acknowledgment form was not found in Patient #6’s paper or electronic chart. The Facility Administrator was informed of the findings on 02/03/2025.”

“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: 44367 Based on observations, the facility’s administration failed to ensure that a copy of the address, and contact numbers of the State Survey Agency (SSA), was prominently displayed where it can be easily seen and read by the patients, and/or patient advocates. This failure denied the patients their rights to report a complaint. Findings included: The Office of Health Care Quality (OHCQ) located at 7120 Samuel Morse Drive, Second Floor, Columbia, MD 21046, contact number is (410) 402-8015 must be easily accessed by patients, caregivers, advocates, and staff to make complaints and/or make inquiries regarding the services provided by dialysis facilities. During observation of the patient’s waiting room on 01/30/2025 at 01:45 p.m., the surveyor noted that the complaint information of the SSA/Office of Health Care Quality (OHCQ) was not posted and easily seen by patients, visitors, and staff. The Facility Administrator was informed of the findings on 01/30/2025.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on record review of medical records, the Facility’s Administration and the Medical Director failed to ensure that initial nursing assessments were performed by the assigned registered nurse prior to a patient’s initial dialysis treatment when being admitted to the facility. This failure placed the affected patient(s) at risk for receiving insufficient and ineffective care and denied the patients their rights. Patient: #1, #2, #3, #4, and #9 Findings included: Review on 02/03/2025 of the facility’s policy 1-03-07 entitled “New Patient Pre-Treatment Evaluation” revealed that “An RN, as required by federal regulation, will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility.” Review on 02/03/2025 of the selected patients’ charts revealed that 5 out of 10 or 50% of the patients did not have an initial nursing assessment completed at the time of admission. The patients electronic and paper charts were reviewed with the Facility Administrator, but the initial nursing assessments were not found. The Facility Administrator corroborated that the initial nursing assessment were not completed on Patients #1, #2, #3, #4, and #9.”

“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: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment and Plan of Care (POC) was completed for all new patients within the latter of 30 calendar days or 13 Hemodialysis sessions beginning with the first outpatient dialysis session. This failure placed the affected patients at potential risk of harm and denied patients their rights. Patients: #2 and #3 Findings included: Review on 02/03/2025 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care,” revealed that “A comprehensive assessment will be conducted on all patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” Review on 02/03/2025 of the facility’s medical records revealed that two (2) out of the ten (10) or 20% of the selected patients did not have an initial (30-day) assessment completed in their paper or electronic charts. The assessment was not completed or completed after the patient’s admission date. The documentation revealed the · Patient #2 was admitted on 08/31/2009. A 30-day assessment was not found in Patient #2’s paper or electronic chart. · Patient #3 was admitted on 03/16/2017. A 30-day assessment was not found in Patient #2’s paper or electronic chart. The Facility Administrator was informed of the findings on 02/03/2025.”

“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: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration and the Medical Director failed to ensure that the clinical staff complied with the appropriate procedures when assessing the patients’ vascular access prior to cannulation and practiced the correct infection control protocol. This failure placed the safety and well-being of the patients at potential risk of harm in maintaining their vascular access. Staff: #1, #2 and #3 Findings included: Review on 01/31/2025 of the facility’s policy 01-04-01E entitled “Cannulation of Fistula or Graft” states “Do not palpate insertion site once are has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” Review on 01/31/2025 of the facility’s policy entitled “AV Fistula or Vein Graft - Initiating Dialysis for Mature Access” states that, “Before initiating dialysis the Dialysis Tech or nurse shall determine the integrity of the vascular access by palpating for a thrill and auscultating for a bruit...Aseptic technique shall be followed when initiating dialysis.” 1. Observation of the clinical treatment area on 01/31/2025 at 10:28 a.m. revealed that during treatment initiation at station #11, Staff #1 palpated the patient’s access after cleaning prior to cannulation. Staff #1 did not re-clean the access. Staff #1 also did not use a stethoscope to auscultate for a bruit prior to cannulation. 2. Observation of the clinical treatment area on 01/31/2025 at 10:31 a.m. revealed that during treatment initiation at station #7, Staff #2 palpated the patient’s access after cleaning prior to cannulation. Staff #2 did not re-clean the access. Staff #2 also did not use a stethoscope to auscultate for a bruit prior to cannulation. 3. Observation of the clinical treatment area on 01/31/2025 at 10:34 a.m. revealed that during treatment initiation at station #4, Staff #3 palpated the patient’s access after cleaning prior to cannulation. Staff #3 then auscultated access with a stethoscope and did not re-clean the access prior to cannulation. The Facility Administrator was informed of findings on 01/31/2025.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patient’s medical records were completed and accurate. This failure denied the patients their rights to formulate their own treatment decisions. Patients: #6 Findings included: Review on 02/03/2025 review of the facility’s policy 3-02-02 entitled “Medical records Documentation Guidance” revealed “All handwritten entries must be legible in the medical record...Do not chart in advance (before the service, observation or order)...Document accurately and concisely but completely.” Review on 02/03/2025 of selected Patient #6’s chart revealed that a consent for hemodialysis was not completed. The Administrative Assistant and the Facility Administrator was given the opportunity to provide a consent for Patient #6; However, no other documentation was provided.”