Davita Bertha Sirk Dialysis Center

“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 review of the facility’s policies and procedure, the facility’s governing body failed to ensure a sanitary environment at all times. This failure placed the patients and the staff at potential risk for exposure to infectious diseases through cross contamination. Findings Included: On 02/09/2024 at 12:30 p.m., during record review of the facility’s policy titled Infection Control in Dialysis Facilities (Policy 1-05-01) Page 2 number 8 states, “Supplies will be stored in a manner that maintains their integrity. Anytime the integrity of a package with or without an expiration date is in question,... the package and its contents must be disposed of and not used.” On 02/05/2024 at 11:49 a.m., during observations of the clinical treatment floor, the surveyor observed 2 opened nipro 14G safety fistula needles along with other clean fistula needles located in the storage cabinet between stations 4 and 9. This observation was witnessed by Staff #8 who corroborated that the 2 opened safety fistula needles should have been disposed of.”

“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: 47759 Based on observations and a review of the facility’s policies and procedures, the facility ’ s governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated equipment being used in the facility. This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings Included: On 02/09/2024 at 12:30 p.m., during record review of the facility ’ s policy on Infection Control in Dialysis Facilities, (Policy 1-05-01) Page 3 number 12 letter A states, “Prior to routine disinfection, remove all visible blood ... Cleaning of visible blood should be performed when first observed.” Number 13 states, “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 the patient or their belongings ... and frequently contacted by healthcare personnel” Number 13 a ii. States, “Priming containers are to be emptied prior to disinfection. On 02/07/2024, during observations of the clinical treatment floor, the surveyor observed the following: 1. At 10:00 a.m., during disinfection of Station #12, the surveyor observed that Staff #10 did not disinfect the acid-dialysate jugs. 2. At 10:11 a.m., during disinfection of Station #15, the surveyor observed that Staff #5 did not empty the prime bucket nor disinfect it. 3. At 10:15 a.m., during disinfection of Station #9, the surveyor observed that Staff #3 did not empty the prime bucket nor disinfect it. 4. At 11:10 a.m., during disinfection of Station #7, the surveyor observed a small residue of a red tinge color located on the chair located in Station #7. Staff #3 stated that the previous patient that was sitting on Station #7 had post treatment bleeding. 5. At 01:40 p.m., during disinfection of Station #1, the surveyor observed that Staff #1 did not open the dialysis chair upon disinfection and did not empty the prime bucket nor disinfect it.”

“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’s governing body 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. Findings Included: On 02/09/2024, at 12:35 p.m., during record review of the facility’s policies and procedure titled Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps (Procedure 1-04-02 B) page 2 states, “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, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab.” On 02/07/2024, during observations of the clinical treatment floor, the surveyor observed the following: 1. At 11:06 a.m., during CVC treatment initiation, the surveyor observed that Staff #3 scrubbed Patient B’s venous hub for 6 seconds and the arterial hub for 3 seconds. 2. At 02:00 p.m., during CVC treatment initiation, the surveyor observed that Staff #1 did not clean Patient J’s exit site. The surveyor also observed that Staff #1 scrubbed each hub of Patient J for 4 seconds each.”

“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 observations and review of the facility policies and procedure, 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 02/09/2024 at 12:40 p.m.., during record review of the facility ’ s policies and procedure titled Water treatment Systems Minimum Component Requirement page 1 number 2 states, “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 02/05/2024, at 12:50 p.m., during observations of the facility ’ s physical environment, the surveyor observed that the room where the acid concentration gallon was stored and transferred was unlocked and easily accessible to the general public. On 02/09/2024, at 12:25 p.m., the Facility Administrator corroborated that the room where the acid concentration gallon was stored should be locked at all times as it poses a risk of tampering thereby placing patients at potential risk of harm.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 47759 Based on staff interviews, observations and reviews of policies and procedures, the facility’s governing body failed to ensure that a label (with the correct concentrate, date and preparer) has been affixed to the reusable concentrate containers. This failure placed the patients and staff at potential risk of harm. Findings Included: On 09/092024 at 01:25 p.m., during record review of the facility ’ s policy titled “Acid Concentrate System, Incoming Acid Concentrate and Supply Log and use of Acid Gallon Concentrate Containers”, page 2 number 14 states “When transferring acid into reusable containers, the device used to transfer needs to be designed and labeled for a specific acid concentrate: (1) Label acid concentrate jugs with the content identified; (2) 45X sticker (3) Hazardous Material Identification Guide (HMIG) sticker.” On 02/05/2024 at 10:35 a.m., during observations on the treatment floor, the surveyor noted that the jugs located on the stations (Stations #1, 2, 3, 5, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 16) did not have labels (with the correct concentrate, date and preparer) attached to the jugs. On 02/05/2024 at 10:40 a.m., Staff #3 was interviewed about the lack of labels; according to the staff member, all the jug concentrates were 2K (Potassium) /2.5 Ca (Calcium) dialysate from the gallon of 2K/2.5Ca dialysate concentrate and all the teammates were aware. On 02/05/2024 at 12:00 p.m., during interviews with the Facility Administrator, the Facility Administrator corroborated that the staff members should have labels on any type of liquid to properly identify the item.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 47759 Based on observations, record review and staff interview, the facility’s governing body failed to ensure that pH was performed before starting the treatment of each patient. This failure placed the patient affected at potential risk of harm. Findings Included: On 02/09/2024 at 12:45 a.m., during record review of the facility’s policies and procedure titled “Testing pH and conductivity of proportioned dialysate and verification of temperature of proportioned dialysate” page 1 number 6 states “Independent pH is required to be performed prior to each treatment” On 02/07/2024 from 10:00 a.m. -03:00 p.m., during observations of the clinical treatment floor, the surveyor observed that Staff #1 did not test the pH prior to patient treatment. To confirm this finding, at 03:15 p.m., the surveyor interviewed Staff #1. According to Staff #1, pH testing is done once in the morning and not done prior to each treatment.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure an environment free from defects or hazards in order to maintain safety and functionality. This failure placed the patients, staff and visitors at potential risk of harm including injury or infection. Findings included: On 02/09/2024 at 12:50 p.m., during review of the facility’s policies and procedures titled “Physical Environment” (Policy: 08-04-01) page 1 number 1 states, “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public safe, functional, and comfortable treatment environment.” Number 2 states “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public.” 1. On 02/07/2024, at 09:42 a.m., During inspection of the bio-medical room, the surveyor observed a. Two (2) ceiling tiles with brown residue that were dangling. b. Four (4) missing ceiling tiles c. A hole on the wall approximately Two (2) by Two (2) inches. 2. On 02/05/2024, at 12:40 p.m., During inspection of the treatment floor, the surveyor observed a. Several tears on the employee chair b. A small tear on the chair located in station #2. c. An exposed electrical panel on the wall near Station #16.”

“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 and staff interview, the facility’s governing body failed to ensure that the dialysis prescriptions were the same as what the patients received. The failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm or injury. Findings included: On 02/09/2024 at 12:55 p.m. during review of the facility’s policies and procedures titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, (Policy 1-03-08) page 4 number 10 states, “If the dialysis prescription is not being met (including dialysis flow rate or change to inability to obtain prescribed blood flow rate or BFR) the reason will be documented, and the licensed nurse informed.” Page 5 states, “Members of the patient care team should report any changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ...Post-treatment: If patient is above or below 1 kg from the target weight” ....Page 3 number 8 states, “The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation.” On 02/05/2024, at 02:00 p.m., during record review of the sampled patients’ treatment flowsheet, the surveyor noted the following: 1. On treatment date 02/02/2024, Patient A had a BFR prescription order of 400 mL/minute., during review of Patient A’s treatment flowsheet, the surveyor observed that the BFR was set at 330 mL/minute from 01:02 p.m. -02:32 p.m with no supporting documentation explaining why the BFR was not followed. 2. On treatment date 02/02/2024, Patient B had a pre-weight of: 55.5 kg with the maximum ultrafiltration rate (UFR) being 721 mL/hr, during review of Patient B’s treatment flowsheet, the surveyor observed that the UFR was set at 860 mL/hr from 10:51 a.m. -02:00 p.m. with no supporting documentation explaining why the ordered prescription was not followed. 3. On treatment date 01/29/2024, Patient B had a pre weight of: 56.3 kg with the maximum UFR being 732 mL/hr, during review of Patient B’s treatment flowsheet, the surveyor observed that the UFR was set at 990 mL/hr from 11:02 a.m. -02:02 p.m. with no supporting documentation explaining why the ordered prescription was not followed. 4. On treatment date 02/02/2024, Patient D had a DFR prescription order of 800 mL/minute., during review of Patient D ’ s treatment flowsheet, the surveyor observed that the DFR was set at 500 mL/minute from 02:08 p.m. - 05:03 p.m with no supporting documentation explaining why the DFR was not followed. 5. On treatment date 01/29/2024, Patient E had a pre weight of: 54.5 kg with the maximum UFR being 708 mL/hr, during review of Patient E ‘s treatment flowsheet, the surveyor observed that the UFR was set at 840-1560 mL/hr from 09:45 a.m. -12:52 p.m. with no supporting documentation explaining why the ordered prescription was not followed. 6. On treatment dates 02/02/2024, 01/31/2024, and 01/29/2024, Patient G did not meet the target weight post treatment. On 02/02/2024, Patient G was over 4.3 kg, On 01/31/2024, Patient G was over 5.2 kg, and on 01/29/2024, Patient G was over 3.6 kg. No documentation acknowledging that the patient did not meet the target weight was found. On 02/09/2024 at 01:10 p.m., during review of the findings, the Facility Administrator corroborated that if the patients treatment orders were not followed and/or abnormalities were noted, the staff members should have documented the inability to follow order treatment and/or abnormalities so that trend can be established and the provider can determine whether a change in prescription would be necessary.”

“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: 47759 Based on patient records reviewed and facility’s policies and procedure, the facility’s governing body failed to ensure that the interdisciplinary team (IDT) members, including the patient or the patient ‘s designee met as a team in order to discuss the patients’ plans of care (PoC); or if the patient chooses not to sign the plan of care, choice must be documented on the plan of care, along with the reason the signature was not provided. This failure denied the affected patients their rights to a minimum standard of medical care. Findings Included: On 02/05/2024 at 01:30 p.m., during record review of the facility’s Interdisciplinary team (IDT) Patient Assessment and Plan of Care (Policy 01-14-01) page 1 number 1 states “The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician or Non-Physician Practitioner (NPP)... a social worker, and a dietician.” Number 2 States “The IDT is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient ’ s treatment plan and expectation for care.” Each team member is expected to sign the Plan of Care (PoC), including the patient, showing that everybody agrees with the patient’s individualized assessments, needs, treatment, and progress . The patient’s signature is to acknowledge the information in the plan. If the patient chooses not to sign their PoC, the reason for refusal must be documented. On 02/05/2024 at 01:25 p.m., during record review of the selected patient’s Plan of care (PoC), the surveyor observed the following 1. Patient C, D, and E did not have a signed and therefore incomplete plan of care for the year 2023. Patient C and E’s last plan of care was completed in November 2022. Patient D’s last plan of care was completed in December 2022.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 47759 Based on review of Quality Assessment and Performance Improvement (QAPI) meeting minutes and interviews with staff, the facility’s governing body failed to (1) ensure that the facility incorporated hospitalization data in QAPI, (2) tracked hospitalization data in QAPI, and (3) analyzed the hospitalization data gathered to identify potential problems and opportunities for improving care. This failure placed patients at potential risk of harm by failing to utilize the data gathered to identify potential problems in the facility resulting in delay in interventions aimed at improvement. Findings Included: On 02/09/2024 at 01:00 p.m.,, during record review of the facility’s Continuous Quality Improvement Program (Policy 12-16-06) page 1 number 7 states, “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: ... hospitalizations.” Number 8 states, “continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to ensure improvements are sustained.” On 02/09/2024 at 11:20 a.m. during record review of the facility’s Facility Health Record (FHR) meeting for October, November and December. The surveyor observed that hospital data, hospitalization analysis and hospitalization action plan was not included in the FHR meeting. At 11:30 a.m., during interviews with the Facility Administrator (FA), the FA corroborated that the facility’s interdisciplinary team failed to document the analysis performed on hospitalization data and actions taken to identify potential problems and opportunities for improving care.”

“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, observation and staff interviews, the facility’s governing body failed to collect and aggregate data regarding adverse event occurrences. This failure places the patients at risk for harm. Findings included: On 02/09/2024 at 01:05 p.m., during review of the facility ’ s policy titled Risk Event Reporting Policy, (Policy 13-01-02) Page 1 number 2 states “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. “ On 02/09/2024 at 11:00 a.m., during record review and interview with the Facility Administrator, the surveyor discovered that an event that occurred on 2/07/2024 at 10:37 a.m. was not reported in the facility’s Risk Event Management also known as REM: 1. On 02/07/2024 at 10:37 a.m., Patient I had post treatment bleeding which according to Staff #2 had been bleeding for “more than 30 minutes.” This incident was not documented on the Adverse Event Report upon review on 02/09/2024. 2. On 02/09/2024 at 11:45 a.m., according to Staff #1, that incident was not an isolated event, Patient I often experience post treatment bleeding. Upon informing the Facility Administrator about this information, the Facility Administrator corroborated that the staff members need further education on documenting REM reports.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to ensure an adequate number of qualified and trained staff to meet the needs of the patients. This failure placed the patients at potential risk and denied their rights to a minimum standard of medical care. Findings Include: The Code of Maryland Regulations 10.05.04.06C (Dialysis Monitoring for Freestanding Kidney Dialysis Centers) states: (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients. ... (c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (d) The charge nurse may not be included in the staffing ratio except: (i) When there are nine or fewer patients; or (ii) In the event of an emergency. On 02/06/2024 at 11:10 a.m., a review of the facility’s staffing exception report from December 2023 through January 2024 revealed that staffing ratios did not meet the requirements on the following dates: a. December 2023: 6, 11, 18, 22 and 24 b. January 2024: 3, 5, 8, 10 and 15 In all instances, the charge nurse was either included in the staffing ratio or had to monitor patients. On 02/09/2024 at 01:20 p.m., The Facility Administrator corroborated that the facility has been experiencing short staffing in the last 2 months.”