Davita Calverton Dialysis

“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: 47759 Based on observations and record review, the facility’s governing body failed to ensure that the clinical staff took adequate measures in order to prevent the transmission of infectious organisms and the possibility of exposure from contaminants. This failure placed patients and staff at potential risk of harm. Findings Included: On 11/03/2023 at 02:30 p.m., during record review of the facility’s Granuflo Dissolution Unit Manufacturer’s direction for use, the surveyor noted that on page 29 the policy stated: “Clean the exterior surface of the Dry Acid Dissolution Unit (DADU) thoroughly after each batch of concentrate is mixed.” On 11/01/2023, at 12:47 p.m., during inspection of the water room, the surveyor, observed the following: 1. White residue was observed on the floor of the water room. 2. White residue was observed around the granulo-flo acid container. On 11/01/2023, at 12:50 p.m., the covering Facility Administrator, who was observing with the surveyor, corroborated that there were white residue scattered around the granulo-flo acid container as well as as on the floor of the water room.”

“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: 47759 Based on record review and staff interview, the facility’s governing body failed to ensure routine testing was done for all patients. This failure placed patients and staff at potential risk of contracting infectious diseases. Findings Included: On 11/03/2023 at 02:35 p.m. during record review of the facility’s policies and procedure, the surveyor noted that according to the facility’s policy Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance (Policy 1-05-02) page 4, stated: “susceptible patients with X<10 HBsAb must have HBsAg testing done monthly.” According to the Centers for Disease Control and Prevention (CDC), although the incidence of Hepatitis B virus (HBV) infection is low among chronic hemodialysis patients, preventing transmission depends on timely detection of patients converting from HBsAg negative to HBsAg positive and rapid implementation of isolation procedures before cross-contamination can occur. On 11/02/2023, at 09:30 a.m., during record review of the facility ’ s vaccination and surveillance report, the surveyor noted the following: 1. Patient #10, a susceptible patient with a HBsAb <10, was missing Ag for the month of 07/2023. 2. Patient #11, a susceptible patient with a HBsAb <10, was missing Ag for the month of 07/2023. 3. Patient #12, a susceptible patient with a HBsAb <10, was missing Ag for the months of 07/2023, 08/2023, 09/2023, 10/2023. On 11/06/2023 at 11:50 a.m., the FA corroborated that the noted testing for hepatitis B had not been conducted for the three sampled patients.”

“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: 47759 Based on observations and review of policies and procedures, the facility failed to ensure that staff utilized aseptic technique when accessing central venous catheters. The failure to utilize aseptic technique when accessing central venous catheters increased the risk for serious infection(s) and related patient harm. Staff #7 Patients #5 and #13 Findings Included: On 11/03/2023, at 02:40 p.m. during record review of the facility ’ s policies and procedure, the surveyor noted that according to the facility’s policy Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps (Procedure 1-04-02 B) 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 of the policy stated, “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...” On 11/01/2023, during clinical observations, the surveyor observed the following: 1. At 01:30 p.m., during treatment termination, Staff #7 disconnected the bloodline from Patient #5 ’ s CVC line and immediately flushed the CVC line with normal saline without performing a 15 second hub scrub per policy. 2. At 01:45 p.m., during treatment termination, Staff #7 disconnected the bloodline from Patient #13 ’ s CVC line and immediately flushed the CVC line with normal saline without performing a 15 second hub scrub per policy.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 47759 Based on review of the facility policies and procedure and observations, the facility’s governing body failed to ensure that the water room remained secured and restricted from unauthorized access. This failure placed the quality of the water supply at potential risk of tampering thereby placing patients at potential risk of harm. Findings Included: On 11/03/2023 at 02:50 p.m., during record review of the facility ’ s policies and procedure, according to the facility ’ s policy Water treatment Systems Minimum Component Requirement, page 1 number 2 stated: “Access to the water treatment system should be restricted to those personnel/trained teammates responsible for monitoring, maintenance of the system and supply ordering.” On 11/01/2023, at 12:45 p.m., during observations of the water room, the surveyor noted that the following: 1. The door with direct access to the water room was propped open by a door stopper. 2. The facility’s “supply” door, which also gives access to the facility ’ s water room, was propped open by a box.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 47759 Based on observations and record review, the facility’s governing body failed to ensure enough sodium chloride is inside the brine tank. This failure placed the patients at potential risk of harm. Findings Included: The primary use of softeners in hemodialysis water systems is to prevent hard water deposits from damaging sensitive reverse osmosis membranes. A reverse osmosis (RO) system is the primary method for purifying water for dialysis treatments, ensuring patients receive safe, clean water. According to the manufacturer’s Directions for Use (DFU) posted on the facility’s brine tank, the staff must “verify salt level is above water level in the brine tank. As needed, add salt to the brine tank & record salt addition on daily log.” On 11/01/2023 at 12:45 p.m., during observations of the water room, the surveyor observed that the salt level of the bring tank was below the water level. The covering Facility Administrator, who was observing with the surveyor, corroborated that the salt level of the brine tank was below the water level.”

“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: 47759 Based on observations and record review, the facility ’ s governing body failed to ensure a dialysis facility that was constructed, equipped, and maintained to provide dialysis patients and staff a safe and functional environment. This failure placed the staff and patients at potential risk of harm, including injury or infection. Findings Included: On 11/06/2023., at 10:00 a.m., during record review of the facility ’ s policies and procedure, the surveyor noted that according to the facility ’ s policy “Physical environment,” page 1 number 1 stated: “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. On 11/01/2023, during observations of the facility, the surveyor noted the following: 1. The surveyor observed five patient chairs with peeled off exterior covering located in the waiting room. 2. The surveyor observed a brown, black, and orange type of floor marking located in the facility ’ s previous “reuse” room. On 11/03/2023, during observations of the facility ’ s treatment floor, the surveyor noted a peeled flooring and wall near station number 11. The Biomedical Operations Manager of the facility, who was observing with the surveyor, corroborated that there was a peeled flooring and wall near station number 11.”

“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: 47759 Based on record review, the facility’s governing body failed to ensure that patients had an opportunity to provide or create advanced directives to be entered into the medical record. This increased the risk for rights violations where patient wishes would not be understood and honored by facility staff. Findings Included: Advance directives establish in writing an individual’s preference with respect to the degree of medical care and treatment desired or who should make treatment decisions if the individual should become incapacitated and lose the ability to make or communicate medical decisions. On 11/2/2023, at 10:30 a.m., during record review of the sampled patient ’ s medical chart, the surveyor noted the following: 1. Patient #4, #5, and #6 did not have an “acknowledgement of advance directive policy” documentation in file. On 11/06/2023 at 11:45 a.m., the FA corroborated that Patients #4, #5, and #6 did not have an “acknowledgement of advance directive policy” documentation in file”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47759 Based on record review, the facility staff failed to adhere to prescribed orders for blood flow rates during procedures, and failed to document any reason why they did not follow the prescribed orders. The failure to follow prescribed orders for blood flow rates during dialysis procedures (1) increased the risk that individual procedures would be less effective and (2) increased the risk for patient harm. This was evident for patients: #4, #5, and #6 Findings included: On 11/03/2023, at 03:00 p.m., during record review of the facility ’ s policies and procedure, surveyor noted the policy on Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, Policy 1-03-08. Page 4 number 10 of the policy stated: “If the dialysis prescription is not being met (including dialysis flow rate [DFR] or change to inability to obtain prescribed blood flow rate [BFR]) the reason will be documented, and the licensed nurse informed.” On 11/02/2023, at 11:30 a.m., review of medical records revealed that facility staff failed to follow prescribed orders as detailed below: 1. Patient #4 had a BFR prescription of 350 mL/minute and a DFR prescription of 500mL/minute. On treatment date 10/25/2023, it was noted that the BFR for this patient was set at 300 from 10:05 a.m.-02:05 p.m. and the DFR was set at 600 mL/minute from 10:41 a.m.- 02:21 p.m. with no supporting documentation found explaining why the BFR and the DFR prescription was not followed. 2. Patient #6 had a DFR prescription of 500mL/minute. On treatment date 10/23/2023, it was noted that the DFR was set at 800 mL/minute from 11:00 a.m. -12:08 p.m. with no supporting documentation found explaining why the DFR prescription was not followed. 3. Patient #5 had a BFR prescription of 400 mL/minute and a DFR prescription of 500mL/minute. On treatment date 10/27/2023, it was noted that the BFR for this patient was set at 350 from 11:01 a.m.- 01:01 p.m. and the DFR was set at 600 mL/minute from 10:43 a.m. -01:48 p.m. with no supporting documentation found explaining why the BFR and the DFR prescription was not followed.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 47759 Based on record review of the facility’s Quality Assessment and Performance Improvement (QAPI) and facility’s policies and procedures, the Facility’s Administration and the Medical Director failed to ensure QAPI meetings were held with all of the members of the facility’s interdisciplinary team (IDT). This failure compromised the opportunity to improve patient safety and outcomes thereby placing the patients at potential risk for harm. Findings include: The IDT, as a diverse group, brings diverse knowledge, experience and perspectives that could help review performance data, identify areas for improvement, as well as conduct and monitor improvement efforts. On 11/06/2023, at 10:05 a.m., during record review of the facility’s policies and procedure, the surveyor noted that according to the facility’s policy 1-14-06 “Continuous Quality Improvement Program”, number 1: “Each dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team (IDT): Facility Medical Director, Facility Administrator, Registered Nurse, Biomed Service Specialist, Registered Dietician, and Social Worker.” On 11/06/2023, at 11:00 a.m., during record review of the facility’s QAPI meeting, the surveyor noted that for the months of July, August and September, the biomedical Service Specialist and the clinical manager were missing from the attendance sheet and therefore not present in the meetings. The Facility Administrator corroborated that for the months of July, August and September, the biomedical Service Specialist and the clinical manager were missing from the attendance sheet and therefore not present in the meetings.”

“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: 47759 Based on record review and staff interviews, the facility’s governing body failed to record adverse event occurrences as soon as possible after they occur as well as discuss Adverse Events in the facility’s Quality Assurance and Performance Improvement (QAPI). This failure placed the patients at potential risk for harm. Findings included: According to the facility’s policy 13-01-02 “Risk Event Reporting Policy,” page 1 number 1: “Any unexpected event that is inconsistent with the routine operation of a dialysis facility, routine provision of acute dialysis or ancillary renal-related services may be a risk event.” Page 1 number 2 stated: “All risk events will be promptly reported to the Facility Administrator/Manager or designee ...The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened.” According to the facility ’ s policy 1-14-06 “Continuous Quality Improvement Program,” page 1 number 7 stated: “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following: Patient Safety, including: ... review of trends of adverse patient occurrences, review of product, equipment” On 11/03/2023, at 10:06 a.m., the surveyor discovered that there were issues with the facility’s machine causing a delay in patient care. According to a staff member who requested to remain anonymous, two machines needed to be replaced by the backup machines. See the interview below: Surveyor: Can you tell me about what happened this morning? Anonymous Staff #1: Two machines broke down this morning and had to be switched with the back up machines. Machines here break down and cause delay in patient treatment Surveyor: Is this the first time this has happened? Anonymous Staff #1: No. This has happened before. On 11/06/2023, at 10:00 a.m., when the surveyor asked the Facility Administrator (FA) if there were any adverse events logged on 11/03/2023, the FA stated “no.” As a follow up question, the surveyor mentioned the three adverse events logged on 07/21/2023, 09/04/2023, and 09/11/2023,and asked the FA whether these adverse event occurrences are being talked about in QAPI, the answer was no.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 47759 Based on record review and staff interview, the facility ’ s governing body failed to ensure that all grievances are being filed, resolved, trended, and presented in Quality Assurance and Performance Improvement (QAPI). This failure poses a potential risk of safety to the patients, and denies patients their rights to a minimum standard of medical care. Findings Included: According to the facility ’ s policy 3-01-06A, “Addressing Patient grievances: DaVita Teammates,” page 1 number 1 stated: “Patient grievances may be verbal or written. They may be submitted directly to a facility teammate or submitted to the DaVita Guest Services department. Number 2 stated: “all complaints/grievances should be documented on the facility Patient Grievance Log.” On 11/06/2023, at 11:00 a.m., during review of the patient grievance log and interview with the Facility Administrator (FA), the surveyor noted a complaint written on behalf of Patient #14. When the surveyor asked the FA for the educational inservice provided to the staff members as stated on the “resolution,” the FA was not able to provide the documentation. 1. At 11:10 a.m., during interview with the FA, the surveyor asked if there were other patients that had filed complaints about delay in treatment time as well as machines breaking down. The FA stated yes, Patients #7, #8, and #15. The surveyor then asked for documentation of the grievances filed on behalf of the complainants. The FA was not able to present the surveyor any documentation except for one anonymous complaint. 2. At 11:15 a.m., during record review of the facility ’ s QAPI, the surveyor asked the FA to present documentation that the facility is talking about patient complaints/grievances on QAPI, the FA was not able to present documentation.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 47759 Based on record review, patient interviews, and staff interviews, the facility’s governing body failed to ensure that indicators regarding facility’s management and performances are continuously being measured, analyzed, tracked and presented in Quality Assurance and Performance Improvement (QAPI). This failure poses a potential risk of safety to the patients and denies patients their rights to a minimum standard of medical care. Findings Included: On 11/06/2023 at 10:10 a.m., during record review of the facility’s policies and procedure, the surveyor noted that according to the facility’s policy 1-14-06 “Continuous Quality Improvement Program,” page 1 number 7 stated: “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following: Patient Safety, including: ... review of trends of adverse patient occurrences, review of product, equipment.” Number 8 stated: “Continuous monitoring of the ...indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, and will track this change in performance over time to verify improvements are sustained.” On interviews conducted on 11/01/2023-11/03/2023 and 11/06/2023, 5 out of the 8 patients interviewed stated that the facility had ongoing issues with machines. On interviews conducted on 11/03/2023, two (2) staff members who requested to be anonymous shared to the surveyor that the facility has had ongoing issues since February of 2023. The Facility Administrator (FA) and the Social Worker corroborated that the facility has had ongoing issues since February of 2023. On 11/06/2023, during Quality Assurance and Performance Improvement (QAPI) review, the surveyor asked the FA for documentation regarding machine issues, how it was being monitored, analyzed, tracked, and presented in QAPI. The FA was not able to present documentation. The surveyor educated the Facility Administrator (FA) on the importance of QAPI and how it is utilized by the governing body to make the necessary improvements in the facility.”