Davita Harford Road Dialysis Center

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 36839 Based on clinical observations and a review of the facility’s policies and procedures, the facility’s administration failed to ensure that the standards of care related to hand hygiene requirements were complied with by all of the clinical staff. This failure placed all patients at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Findings included: The facility’s policy and procedure 1-03-12A, page 2, #14-#15 states: (14) Disconnect venous blood line from venous access. (15) Discard gloves, perform hand hygiene and put on new gloves. Rationale: Hand hygiene and new gloves are used for performing post dialysis access care per procedure. On 2/5/2025 at 1:27 p.m., the patient care technician assigned at station #13 was observed touching the buttons of the dialysis machine during rinseback then proceeded to remove the patient’s access needles without changing gloves and performing hand hygiene in between.”

“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: 36839 Based on observations and a review of the facility’s policies and procedures, the governing body failed to ensure that the clinical staff followed their policy on implementing proper utilization of personal protective equipment (PPE) on the clinical treatment floor. This failure placed all the patients and staff at risk of exposure to infectious diseases and blood borne pathogens. Findings included: According to the Centers for Disease Control and Prevention (CDC), used personal protective equipment (PPE) is considered “contaminated” from areas that have or are likely to have been in contact with body sites, materials, or environmental surfaces where the infectious organism may reside. Therefore, when a gown or full PPE is worn, PPE should be removed prior to leaving the treatment area. The facility’s policy and procedure 5-06-01, page 2 states that PPE is to be (5a) Removed prior to leaving the treatment/training area, (5c) PPE is not to be worn in non-treatment areas. On 2/6/2025 at 11:55 a.m., staff #9 was seen in the hallway between the dialysis treatment room and the supply room on her phone wearing a PPE gown.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 36839 Based on observations and a review of the facility’s policies and procedures, the governing body failed to ensure that the items taken to the dialysis stations were either disposed of, dedicated for use on a single patient, or cleaned and disinfected before being returned to a common clean area. This failure placed the patients at potential risk for exposure to blood-borne pathogens and other infectious diseases. Findings included: The facility’s Infection Control policy states: (Policy#12-07-01, page 4, #34) “If electronic thermometers and/or blood glucose meters are used, measures will be taken to prevent cross contamination between patients... If the potential for contamination exists, the device outer casing is wiped with an appropriate disinfectant before being returned to a clean area or using on another patient.” During observations on the treatment floor on 2/5/2025, the following were noted: 1. At 1:40 p.m., a patient care technician (PCT) brought the digital thermometer to station #17 to obtain the patient’s temperature , then returned to the designated clean area without disinfecting it. 2. At 2:10 p.m., a PCT brought the thermometer to station #14 to obtain the patient’s temperature, then returned to the designated clean area without disinfecting it.”

“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: 36839 Based on observations and a review of the facility’s policies and procedures, the governing body failed to ensure that all reusable supplies used by the patients for dialysis were cleaned and disinfected according to standard infection control practices. This failure placed staff and patients at potential risk for exposure to bloodborne pathogens and infectious diseases. Findings included: The facility’s policies and procedures on infection control (Policy 5-06-01, page 3) states: “12b.iv. Items disinfected via submersion will be fully submerged.” During observations on the clinical treatment floor on 2/5/2025 at 2:30 p.m., it was noted that a rectangular basin containing a solution labeled as 1:10 bleach located next to the dirty sink across stations #17 and #18 had blue and white clamps which were not fully submerged.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 36839 Based on observations, the governing body failed to ensure that all clinical staff complied with aseptic techniques when entering injection ports (plastic septum to allow the insertion of a needle to withdraw or inject fluids into a bag or vial). Findings included: According to the Centers for Disease Control and Prevention (CDC), parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it. During observation on 2/5/2025 at 2:20 p.m., staff member #11 was noted inserting a needle into the septum of a heparin vial without wiping the septum first with alcohol.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 36839 Based on observations and interviews with facility staff, the governing body failed to ensure that the reclining chairs used by the patients during dialysis treatment were kept intact and free from damage. This failure placed the well being and safety of the patients and staff at potential risk for harm and possible exposure to infectious diseases. Findings included: Patient treatment chairs are essential for the comfort of patients during dialysis sessions. It is crucial to maintain these chairs to enable effective cleaning and disinfection between patients. Regular inspections should be conducted to identify and address any issues promptly. Torn upholstery on patient treatment chairs should be repaired or replaced to avoid potential contamination and to uphold hygiene standards. Observations and interviews with the clinical staff on 2/5/2025 revealed that several dialysis chairs being used by the patients during treatment have stains and multiple tears on different locations of the upholstery such as the seats, armrests, and backrests. These findings were confirmed by the clinical coordinator and the facility administrator and again discussed during the exit conference on 2/6/2025.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 36839 Based on observations, the facility’s governing body failed to ensure that every patient’s vascular access was visible during hemodialysis treatment. This failure placed the patients at potential risk of harm and possible death. Findings included: During observations on the clinical floor on 2/5/2025 at 1:20 p.m., the patients at stations #1, #3 and #8 had their vascular accesses covered with a blanket during dialysis treatment for more than 10 minutes.”

“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: 36839 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patients had a completed Medical Orders for Life-Sustaining Treatment Form (MOLST) in their patient records. This failure denied the patient’s rights to formulate treatment decisions that served their end-of-life needs. Patient #8 Maryland Code 10.01.21.04B(4)E(1)(2)(3) mandates that, starting July 1, 2013, kidney dialysis centers must accept, update, and complete the Medical Orders for Life-Sustaining Treatment (MOLST) form during patient admission. When completing or updating the MOLST form, health care facilities must offer patients or authorized decision makers the opportunity to participate. If declined, the facility must document the refusal in the medical record, including the date, time, participants, and a summary of the discussion. Patients are to be informed that the MOLST form becomes part of the medical record, accessible through standard record procedures. A MOLST form must be signed and dated by a licensed physician, nurse practitioner, or physician assistant to be valid. Each page with orders must be signed and dated. A review of the medical records of 9 sampled patients with the facility’s clinical coordinator revealed that Patient #9, whose initial dialysis treatment at the facility was on 11/29/2022, did not have a MOLST form in the chart.”

“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: 36839 Based on medical records reviewed, the governing body failed to ensure that all initial nursing assessments were completed by the assigned registered nurse (RN) prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patients at risk for receiving insufficient and ineffective care, and denied the patients their rights. Patients: #6 and #9 Findings included: A nursing assessment includes a physical examination, the measurement of vital signs, observation of the vascular access, and assessment of a patient’s general condition. It also includes a neurological assessment of the level of alertness and the mental status of the patient, subjective complaints, pain status, activity levels, assessment of the respirations, including auscultation of breath sounds; assessment of cardiac status to include auscultation of the heart sounds, fluid gains, skin color and temperature, and bowel sounds. In order for dialysis treatment to be initiated, each patient must have an initial dialysis prescription, orders for care, and baseline physical and nursing assessments documented and completed before treatment is begun at the facility. Upon review of the sampled patients’ charts with the clinical coordinator on 2/6/2025, the following were noted: 1. Patient #6, whose first dialysis treatment at the facility was on 6/24/2024, had a documented initial nursing assessment completed on 7/3/2024 which was 9 days after the patient’s date of admission. 2. Patient #9’s first dialysis treatment at the facility was on 9/30/2023. No initial nursing assessment was found in the patient’s medical records.”

“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: 36839 Based on a review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff 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. Patient #8 Findings included: A review of the sampled patients’ treatment flowsheets on 2/6/2025 revealed that on treatment date 2/1/2025, Patient #8’s blood flow rate (BFR) ran between 300-350 mL/minute; then on treatment date 2/4/2025, the patient’s BFR was set at 400 mL/minute throughout the dialysis treatment. No supporting documentation was found as to why the prescribed BFR of 450 mL/minute was not followed.”

“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: 36839 Based on review of the sampled patients’ medical records and the facility’s policies and procedures, the governing body, and the interdisciplinary team (IDT) failed to ensure that a 30-day comprehensive assessment had been completed on all new patients within the latter of 30 calendar days, or 13 treatments beginning with the first outpatient dialysis session. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patients: #1, #4, #5, #6, and #7 Findings included: According to the facility’s policies and procedures titled Interdisciplinary Team (IDT) Patient Assessment and Plan of Care (Policy #1-14-01, page 2, #4), “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.” A review of the 9 sampled patients’ medical records with the clinical coordinator on 2/6/2025 revealed the following: 1. Patient #1’s initial dialysis treatment at the facility was on 11/4/2024. No initial comprehensive assessment was documented in the patient’s medical records. 2. Patient #4’s initial dialysis treatment at the facility was on 10/24/2022. The initial comprehensive assessment was not completed until 12/16/2022 which was greater than 30 days from the date of the patient’s first treatment. 3. Patient #5’s initial dialysis treatment at the facility was on 11/21/2024. No initial comprehensive assessment was documented in the patient’s medical records. 4. Patient #6’s initial dialysis treatment at the facility was on 6/24/2024. The initial comprehensive assessment was not completed until 8/5/2024 which was greater than 30 days from the date of the patient’s first treatment. 5. Patient #7’s initial dialysis treatment at the facility was on 7/27/2024. The initial comprehensive assessment was not completed until 9/17/2024 which was greater than 30 days from the date of the patient’s first treatment.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 36839 Based on review of the patients’ medical records and the facility’s policies and procedures, the governing body failed to ensure that the facility’s interdisciplinary team (IDT) completed the 90-day follow-up comprehensive assessment. This failure placed the affected patients at risk for receiving inadequate health care and denied the patients their rights. Patients: #6 and #7 Findings included: According to the facility’s policy (1-14-01, page 2, #5), “A follow-up 90-day reassessment will be completed to evaluate the patient’s status and provide information to adjust the patient’s plan of care.” Upon review of the sampled patients’ medical records on 2/6/2025, the following were noted: 1. Patient #6, who was admitted to the facility on 6/24/2024, had a comprehensive assessment completed on 8/5/2024, and a follow-up reassessment on 12/2/2024 which was greater than 90 days from the day of the comprehensive assessment. 2. Patient #7 , who was admitted to the facility on 7/27/2024, had a comprehensive assessment completed on 9/17/2027. No follow-up 90-day reassessment was found in the patient’s medical records. These findings were verified with the clinical coordinator during medical record review, and again discussed with the facility administrator during the exit conference on 2/6/2025.”

“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: 36839 Based on review of the facility staffing logs and interviews with the clinical staff, the facility’s governing body failed to ensure adequate staffing patterns, and failed to document staffing exception reports in a timely manner. This failure placed the patients’ well-being and safety at risk. Findings included: The Code of Maryland Regulations 10.05.04.06C(1)(a)(b)(c)(i)(ii) for Freestanding Kidney Dialysis Centers states “Dialysis Monitoring. Staffing Ratio. The monitoring individual-to-patient ratio at each center shall be a minimum of one staff member to three participants (patients) and staffing shall be sufficient to meet the needs of patients. The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients; or in the event of an emergency.” The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with this regulation. On 2/5/2025, a review of the 3-week staffing schedule from 1/20/2025 to 2/5/2025 revealed that the facility did not comply with the patient-staff ratio per state regulations on 1/20, 1/22, 1/24, 1/29, 1/31 and 2/3/2025. Additionally, no staffing exception reports were provided for 1/22/2025 and 1/24/2025.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 44367 Based on review of the patient grievance log, the facility’s policies and procedures and interviews with facility staff and patients, the governing body and the facility’s administration failed to follow the facility’s internal grievance process. This failure denied the patients their rights to advocate for themselves for effective care. Findings included: Review on 06/06/2024 of the facility’s policy #3-01-06A entitled “Addressing Patient Grievances: DaVita Teammates states: “ 1. Patient grievances may be verbal or written. They may be submitted directly to a facility teammate or submitted to the DaVita Guest Services department: 2. Complaints/Grievances should be documented on the facility Patient Grievance Log. 3. All details of patient grievances and discussions will be documented.” During an interview 06/05/2024, Patient #1 stated that he/she was not assessed on 06/07/2024 and 06/10/2024. Patient #1 informed the surveyor that a complaint was filed with the social worker on 06/11/2024, but no one followed up with any details of the investigation. Interview with the Social Worker on 07/01/2024 revealed that Patient #1 did “discuss” with him/her that the assessment was not completed by the Registered Nurse on 06/07/2024 and 06/10/2024. The Social Worker informed the surveyor that a grievance was not filed because Patient #1 stated that he/she “will take care if it.” On 06/06/2024, review of the facility’s grievance log for the month of June 2024 revealed that no grievance was filed on Patient #1’s behalf. The Facility Administrator and the Social Worker were informed of the findings on 07/01/2024.”