Davita Charles County 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 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 patients and staff at potential risk for exposure to infectious diseases through cross contamination. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01) Page 2 number 8 stated, “Supplies will be stored in a manner that maintains their integrity ... d. 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.” Page 3 number 13 stated, “At the end of each treatment, the dialysis station will be cleaned and disinfected.” 1. On 03/31/2025 at 11:45 a.m., observations of Room #4 of the Home Program side revealed the following: a. (Two) 2 opened and empty syringes along with pens on the counter were observed. b. A “clean” dialysis chair with a medical tape on the side table and on the seat cushion was observed. 2. On 04/02/2025 at 09:00 a.m., observations of the facility’s treatment floor, revealed the following: a. Cabinet handles (located near Station #7) were covered with white residues. b. Cabinet floor and shelves (located near Station #7 and Station #14) were covered in brown and black residues.”

“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, staff interviews 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 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Physical Environment” (Policy 8-04-01) page 2 number 9 stated “Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only.” On 04/01/2025 at 08:00 a.m., during observations of the water room, the surveyor observed a gap on the door frames that allowed the surveyor entrance without entering the code to the water room. This was witnessed by the Facility Administrator and the Biomedical technician who both agreed that the door structure does not provide sufficient security to the water room.”

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 47759 Based on observations and a staff interview, the facility’s governing body failed to ensure easy access to all components of the water system. This failure placed the water system at risk for possible damage that may affect patient care. Findings Included: According to the American National Standards Institute (ANSI/AAMI RD52:2004), the layout of the water purification system should provide easy access to all components of the system. On 03/31/2025 between 08:00 a.m. -10:00 a.m., during observations of the water room, the surveyor observed: 1. Hemodialysis Concentrate Naturalyte boxes blocking access to valves K1, K3, K4, and SP5 2. Water Softener Pellets blocking access to the water softener tank 3. 2 Yellow containers blocking access to valves A3, A4, B2, and the blending valve. 4. Stacks of boxes blocking access to the secondary chlorine sample. On 04/01/2025 at 08:00 a.m., Interviews with the Bio-Medical technician revealed that easy access to the components are important in case staff members need to access the components at any time.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 47759 Based on record reviews and staff interviews, the facility’s governing body failed to ensure that staff members document the independent residual chemical tests performed prior to the beginning of the daily activities. This failure placed the patients at risk of potential harm. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Water Treatment System Disinfection” (Policy 1-16-01) page 3 number 15 stated, “Facility teammates are to perform independent residual chemical tests prior to the beginning of the daily activities on the first treatment day following a water treatment system or membrane chemical disinfection at all locations.” On 04/01/2025 between 08:00 a.m.-10:00 a.m., during review of the “Titan Minncare HD Testing Documentation”, the surveyor observed that from October 2024 through March 2025, Independent residual chemical tests conducted at every sample location prior to the beginning of daily activities on the first treatment day following a water treatment system or membrane chemical disinfection had not been recorded by facility teammates. According to the Bio-Medical Technician interviewed, facility teammates will be trained on how to correctly complete the “Titan MinnCare HD Testing Documentation” moving forward.”

“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 reviews, the facility’s governing body failed to ensure an environment that is equipped and maintained to provide dialysis patients, staff and the public a safe, functional, and comfortable treatment environment. This failure placed the patients, staff and visitors at potential risk of harm including injury or infection. Findings included; On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Physical Environment” (Policy 08-04-01) 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.” 1. On 03/31/2025 at 11:45 a.m., observations of Room #4 of the Home Program side revealed that two ceiling tiles were missing. 2. On 04/02/2025, At 09:15 a.m., during observations of the treatment floor, the surveyor observed the following: a. A medication cabinet that has a lock that was no longer intact. b. A cabinet located near Station #7 that does not close properly. c. A drawer located at the nursing station with a missing handle.”

“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 record reviews, the facility’s governing body failed to ensure that emergency exits and pathways were clear of obstructions at all times. This failure placed the patients at risk of harm in case of an emergency. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Facility Emergency Management Plan (In Center Hemodialysis and home)” page 14 number 5 stated “The egress area must remain clear at all times” On 04/02/2025 at 09:30 a.m., during observations of the facility’s physical environment, the surveyor observed that one of the emergency exits was blocked by oxygen tanks, a wheelchair, and a 32 gallon trash container.”

“PR-INFORMED OF OWN MEDICAL STATUS CFR(s): 494.70(a)(10) The patient has the right to- (10) Be informed by the physician, nurse practitioner, clinical nurse specialist, or physician’s assistant treating the patient for ESRD of his or her own medical status as documented in the patient’s medical record, unless the medical record contains a documented contraindication; This Standard is not met as evidenced by: 47759 Based on record review, the facility’s governing body failed to ensure that all of the facility’s patients had completed Medical Orders for Life-Sustaining Treatment Form (MOLST) on their patient records in a prompt manner. This failure denied the patients their rights to formulate treatment decisions that served their end of life needs. Findings Included: The Annotated Code of Maryland found at 10.01.21.04B(4)E(1)(2)(3) states the following: Title Department of Health and Mental Hygiene, Subtitle 01 Procedures, Chapter 21 Medical Orders for Life-Sustaining Treatment (MOLST) Form - Procedures and Requirements, .04B Beginning July 1, 2013, the following health care facilities are required to accept, update if appropriate, and complete the MOLST form for each patient during the admission process in accordance with the form’s instructions: (4) A kidney dialysis center. E. When initially completing a MOLST form or updating an existing MOLST form, a health care facility shall: (1) Offer the patient or authorized decision maker the opportunity to participate in completing or updating the MOLST form, and on request of the patient, offer any physician [or], nurse practitioner, or physician assistant selected by the patient the opportunity to participate in updating or completing the MOLST form; (2) Note in the medical record when a patient or an authorized decision maker declines to participate in completing or updating the MOLST form, indicating the date and time of discussion, with whom the form was discussed, and a summary of the discussion; [and] (3) Inform the competent patient or authorized decision maker that the MOLST form will become part of the medical record and can be accessed through the procedures used to access a medical record. On 04/01/2025 at 01:00 p.m., during review of the selected patients’ medical records, the surveyor observed that Patients A, F, and G did not have a MOLST form.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47759 Based on record review, observations, and staff interviews, the facility’s governing body failed to ensure that clinical staff members report pertinent findings to the appropriate medical staff member to ensure safety of patients. This failure placed the affected patients at potential risk of harm and denied the patient the opportunity to have their care re-evaluated in a prompt manner. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Pre-Intra-Post treatment data collection, monitoring, and nursing assessment (policy 1-03-08) page 4 number 11 stated “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse.” Page 4 number 12 stated “The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status.”Page 4 number 13 stated “All findings, interventions and patient response will be documented in the patient’s medical record.” Page 5 stated “Unless other abnormal parameters are established by the facility governing body and documented in the governing body meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order.” Pre-dialysis: “Systolic greater than 180 mmHg” Intradialytic “Systolic greater than 180 mmHg” 1. On 04/01/2025 at 01:00 p.m., review of the Patient J’s treatment flowsheet revealed a pre-blood pressure systolic trend of 180s-230s. Review of treatment flowsheets between 03/01/2025 through 03/29/2025 revealed the following: a. On treatment date 03/01/2025, Patient J’s Initial blood pressure was 213/94 mmHg. No documentation of license nurse and physician notification was observed on the treatment flow sheet or progress notes. b. On treatment date 03/15/2025, Patient J’s initial blood pressure was 207/86 mmHg. No documentation of license nurse and physician notification was observed on the treatment flow sheet or progress notes. c. On treatment date 03/18/2025, Patient J’s initial blood pressure was 193/111 mmHg. No documentation of physician notification was observed on the treatment flow sheet or progress notes. d. On treatment date 03/22/2025, Patient J’s initial blood pressure was 211/88 mmHg. No documentation of physician notification was observed on the treatment flow sheet or progress notes. e. On treatment date 03/25/2025, Patient J’s initial blood pressure was 231/98 mmHg. No documentation of physician notification was observed on the treatment flow sheet or progress notes. f. On treatment date 03/29/2025, Patient J’s initial blood pressure was 209/88 mmHg. No documentation of physician notification was observed on the treatment flow sheet or progress notes. 2.On 04/01/2025 at 01:00 p.m., interviews with the Clinical Coordinator confirmed that per policy, patient care technicians were instructed to report the abnormal blood pressure finding to the nurse. As for nurses, nurses were instructed to document the abnormal finding along with the provider notification on the patient’s medical record unless a parameter has been established for Patient J. According to the Clinical Coordinator, no parameter has been established for Patient J.”

“PA-RD-NUTRITIONAL STATUS CFR(s): 494.80(a)(6) The patient’s comprehensive assessment must include, but is not limited to, the following: (6) Evaluation of nutritional status by a dietitian This Standard is not met as evidenced by: 47759 Based on observations and record reviews, the facility’s governing body failed to ensure that all patients’ nutritional assessments and nutritional plan of care were individualized to address the patients needs. This failure placed Patient J at potential risk of harm and denied their rights to a minimum standard of medical care. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 1-14-01) page 1 number 2 stated “The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs.” Number 3 stated “ Assessment criteria will include, but not be limited to, evaluation of:...Nutritional status by dietitian” On 04/01/2025 at 01:00 p.m., review of the hospitalization records revealed that Patient J was hospitalized on 02/08/2025 due to hyperglycemia. Review of Patient J’s records revealed no documentation of the re-assessment conducted for Patient J’s nutritional condition based on metabolic parameters, particularly glycemic control, or of strategies to avoid hospitalization in the future.”

“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: 47759 Based on observations and record reviews, the facility’s governing body failed to ensure that an initial comprehensive assessment has been conducted on 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 patient at potential risk of harm and denied patients right to a minimum standard of care. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Interdisciplinary team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01) page 2 number 4 stated “A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” On 04/01/2025 at 01:00 p.m., during record review of the selected patients’ Plan of Care (PoC), the surveyor observed the following: 1. Patient A, admitted on 01/2025, had a completed 30 day PoC on 03/2025, approximately 1 month after the due date. 2. Patient E, admitted on 09/2024, had a completed 30 day PoC on 11/2024, approximately 1 month after the due date.”

“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: 47759 Based on record review and observation, the facility’s governing body failed to ensure that the clinical staff members complied with the facility’s access assessment and cannulation protocol. This failure placed patients at potential risk for infection. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Arteriovenous Fistula (AVF) or Arteriovenous Graft (AVG) Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (Policy 1-04-01E) Page 2 provided a list of effective contact time with the minimum contact time as 30 seconds for Providone Iodine and 60 seconds for both ExSept Plus and Isopropyl Alcohol 70%. On 04/01/2025 during observation of AVF/AVG treatment initiation, the surveyor observed the following: 1. At 11:18 a.m., Staff #4 disinfected the patient’s access (patient at Station #3 Machine #5) for 11 seconds total then palpated the patient’s access site again prior to cannulation. 2. At 11:35 a.m., Staff #4 disinfected the patient’s access (patient at Station #2 Machine #10) for 5 seconds total then palpated the patient’s access site again prior to cannulation.”

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 47759 Based on staff interviews and record reviews, the facility’s governing body failed to ensure that implementation of the plan of care was implemented within 15 days of the completion of the patient assessments. This failure denied patients their right to have timely and effective care. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “Interdisciplinary Team Patient Assessment and Plan of Care” (Policy 1-14-01) page 4 number 12 stated “The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment.” On 04/01/2025 at 01:00 p.m., during record review of the selected patients’ Plan of Care (PoC), the surveyor observed the following: 1. Review of Patient B’s Plan of Care (POC) revealed that Patient B’s assessment was first conducted on 04/01/2024, with the Plan of Care completed date as 04/30/2024. Approximately 1 month following the assessment. 2. Review of Patient D’s POC revealed that Patient D’s assessment was first conducted on 09/11/2023 with the POC completed date as 01/03/2024. Approximately 4 months following the assessment. 3. Review of Patient J’s POC revealed that Patient J’s assessment was first conducted on 03/05/2024 with the POC completed date as 04/11/2024. Approximately 1 month following the assessment. 4. Review of Patient K’s POC revealed that Patient K’s assessment was first conducted on 12/11/2023 with the POC completed date as 01/04/2024. Approximately 1 month following the assessment. Interviews with the Clinical Coordinator stated that an immediate inservice will be completed to emphasize the importance of assessing and completing the Plan of Care in a timely manner.”

“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 a review of Quality Assessment and Performance Improvement (QAPI) meeting minutes and interviews with staff, the facility’s governing body failed to ensure that the facility analyzed the hospitalization and mortality 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 potential delay in interventions aimed at improvement. Findings Included: On 04/02/2025 at 08:45 a.m., review of the facility’s policy titled “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 04/02/2025 at 04:30 p.m. during record review of the facility’s Facility Health Record (FHR) and interviews with the Facility Administrator, the surveyor observed that the facility could not produce documentation regarding hospitalization and mortality analysis review as well as action plans related to the trends observed. Interviews with the Facility Administrator stated that moving forward, discussions of analysis and action plans taken to identify potential problems and opportunities for improving care will be documented moving forward.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 47759 Based on record review, the governing body failed to ensure that the patient’s health records were protected from being seen by other patients. his failure denied the patients their rights to privacy and confidentiality of their health information. Findings included: On 03/31/2025 at 09:22 a.m., upon entering the treatment floor from the staff hallway, the surveyor observed patients’ medical hard copy charts visibly exposed and easily accessible to the unauthorized patients and staff members.”