Davita Harbor Park Dialysis

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 47759 Based on observations and a staff interview, the facility’s governing body failed to ensure that biohazardous waste containers were stored in a manner that prevents casual access and potential contamination to the surrounding environment. This failure placed patients and staff at potential risk of exposure to hazardous materials Findings Included: On 10/02/2025 at 01:00 p.m., during observations of the facility’s waste storage areas, the surveyor observed biohazardous waste containers located outside of the designated bio-hazard room. The containers were labeled as containing hazardous materials but were stored in an open hallway area, accessible to anyone passing by. According to the Facility Administrator, the bio-hazard room was too small to accommodate the contaminated containers. As a result, clean containers are stored inside the biohazard room, and the contaminated ones are placed outside, exposed to casual access.”

“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 10/03/2025, 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 10/02/2025 between 12:00 p.m. - 01:00 p.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 finding was also observed by the Biomedical technician who concurred that the door structure does not provide sufficient security to the water room.”

“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, patient interviews, 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 10/03/2025, 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 10/01/2025, during observations of the treatment floor, the surveyor observed the following: a. Dialysis chairs at Stations #3, #15 and #19 had ripped upholstery b. The door connecting the hallway to the storage room as well as the door connecting the hallway to the treatment room had difficulty opening and closing. c. The vent located in the water room had black residues surrounding it.”

“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 and a staff interview, the facility’s governing body failed to ensure that staff accurately completed the Medical Orders for Life-Sustaining Treatment Form (MOLST) forms for 3 out of 5 sampled patients (Patients D, F, and H). This failure placed patients at risk for not receiving care in accordance with their end-of-life-preferences. Findings Included: According to the Maryland Medical Orders for Life Sustaining Treatment (MOLST), “The physician, nurse practitioner (NP), or physician assistant (PA) must accurately and legibly complete the form and then sign and date it. The physician, NP, or PA shall select only 1 choice in Section 1 and only 1 choice in any of the other Sections that apply to this patient. If any of Sections 2-9 do not apply, leave them blank. A copy or the original of every completed MOLST form must be given to the patient or authorized decision maker within 48 hours of completion of the form or sooner if the patient is discharged or transferred. 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. On 10/01/2025 between 08:10 a.m. -09:10 a.m., during review of selected patients’ medical records, the surveyor observed that the MOLST forms for Patients D, F, and H were inaccurately completed. For example: 1. Patient D: the MOLST form included a practitioner’s name and year that were illegible. 2. Patient F: the MOLST form did not include the year in which the form was completed 3. Patient H: the MOLST form did not include the practitioner’s license number, phone number, or the date of completion. Interviews with the Clinical Coordinator corroborated that all MOLST forms should be legible and complete”

“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 observations and record reviews, the facility’s governing body failed to ensure that the dialysis prescriptions were the same as what the patients received. This failure placed the patients at potential risk of harm or injury due to deviations from provider-ordered treatment parameters. Findings Included: On 10/03/2025, during review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment “ (Policy 01-03-08), page 2 number 3 stated, “ Patient identity, prescription and machine settings are verified by teammate ... within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ... b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate (DFR) “ Page 3 number 8 stated, “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 or sooner as required by state law.” Page 4 number 10 stated “ If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.” Definitions: Ultrafiltration Rate (UFR) is a clinical rate, set by the provider, at which fluid is removed from a dialysis patient’s blood during treatment. Dialysis Flow Rate (DFR) is a clinical rate, set by the provider, that specifies the speed at which the dialysate (cleansing fluid) flows through the dialyzer. Blood Flow Rate (BFR)is a clinical rate, set by the provider, that specifies the speed at which blood is pumped from the patient’s body, through the dialyzer, and back into their body On 10/03/2025, during review of 30 dialysis treatment flowsheets, the following discrepancies were identified: 1. Six (6) out of 30 treatments (20%) were performed with a BFR that did not match the physician’s order. a. For example: i. Review of Patient D’s treatment flowsheet for treatment date 09/22/2025 revealed that the patient had a BFR order of 300 mL/min. From 08:42 a.m. - 11:55 a.m., the documented BFR was at 400 mL/min with the Clinical coordinator verification time at 08:53 a.m. stating that “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” 2. Three (3) out of 30 treatments (10%) were performed with a DFR that deviated from the prescribed value. a. For example: i. Review of Patient C’s treatment flowsheet for treatment date 09/23/2025 revealed that the patient had a DFR order of 800 mL/min. From 06:05 a.m. - 10:04 a.m., the documented DFR was between 600-620 mL/min with Staff #5 nurse prescription verification documented at 06:48 a.m. stating that “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” 3. Six (6) out of 30 records (20%) lacked documentation of a nursing assessment within one hour of treatment initiation, as required by facility policy. a. For example: i. Review of Patient A’s treatment flowsheet for treatment date 09/23/2025 revealed that the patient was put on at 09:37 a.m, yet nurse verification by Staff #5 and pre-treatment assessment occurred at 12:12 p.m. On 10/03/2025, According to Staff #4, an immediate inservice will be conducted with the Staff members regarding following provider prescription and notifying the nurse of any abnormalities or inabilities to meet the prescription along with documentation.”

“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 observations and review of the facility’s policies and procedures, 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 10/03/2025, review of the facility’s policy titled “Arteriovenous Fistula (AVF) or Arteriovenous Graft (AVG) Cannulation with JMS Syloc Mini Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (Policy 1-04-01D) 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%. Page 3 number 13 stated “Do not palpate insertion site once area has been prepped.” On 10/01/2025 between 09:30 a.m. -10:30 a.m., during observation of AVF/AVG treatment initiation, the surveyor observed the following: 1. Staff #1 disinfected the access site of the patient at Station #5, Machine #16, for 5 seconds using an alcohol wipe, applied a tourniquet, and then cannulated. 2. Staff #2 disinfected the access site of the patient at Station #7, Machine #19, for 8 seconds with an alcohol wipe, palpated the access site, and cannulated. 3. Staff #1 disinfected the access site of the patient at Station #17, Machine #22, for 5 seconds followed by an additional 4 seconds, then proceeded with cannulation. 4. Staff #3 disinfected the access site of the patient at Station #9, Machine #11, for 10 seconds with an alcohol wipe, palpated the access site, and cannulated.”

“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 the interdisciplinary team implements plans of care within 15 days of the completing patient assessments for 6 of 17 reviewed care plans. This failure placed patients at risk of not receiving timely and appropriate care based on current clinical assessments. Findings Included: On 10/03/2025, 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 10/01/2025 between 08:10 a.m. -09:00 a.m., during record review of the selected patients’ Plan of Care (PoC), the surveyor reviewed 17 plans of care. In 6 of these records, the Plan of Care was either completed late or implemented before all assessments were finalized. Affected patients included: 1. Patient B: 2024 and 2025 Annual Plan of Care 2. Patient D: 90 Day Plan of Care 3. Patient E: 30 Day and 90 Day Plan of Care 4. Patient G: 2024 Annual Plan of Care To give examples: 1. According to documentation, Patient B’s 2024 annual Plan of Care assessment was first completed on 05/08/2024. The Plan of Care was implemented on 06/14/2024, approximately 1 month and 6 days after the assessment date. 2. According to documentation, Patient B’s 2025 annual Plan of Care assessments by the Registered Dietitian was completed on 06/20/2025. The Plan of Care was implemented on 06/06/2025, which was 14 days before the registered dietitian assessment was completed. Interviews conducted with Staff #4 stated that per policy, the Plan of Care following re-assessments must be completed within 15 days.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to ensure that 1.entries on the routine total chlorine testing log and the daily water treatment log were clearly attributable to specific staff members; and 2. an accurate staffing schedule was maintained that clearly reflected the number of patients and staff members present.This failure compromised the facility’s ability to 1. verify that required water quality testing was completed by trained personnel and 2. Effectively monitor staff levels necessary to ensure safe and adequate patient care. Findings Included: 1. Staffing Schedule: a. On 09/30/2025, the surveyor reviewed both the completed Staffing Schedule audit as well as the facility’s daily staffing schedule documentation used to monitor staff-to-patient ratios covering the period from 09/07/2025 to 09/27/2025. The schedules included: i. Scratch-offs, white-outs, and handwritten personal notes ii. Documented downsizing without clear documentation as to which staff left or remained. iii. Checkmarks with no corresponding legend or explanation of meaning b. Example: The schedule dated 09/15/2025 lacked clarity in all above respects. c. During an interview on 09/30/2025, the Facility Administrator acknowledged the lack of clarity in the staffing records and stated that the facility intends to implement a better system to ensure accurate documentation of both patient census and staff assignments. 2. Signature Page a. On 10/02/2025, the surveyor reviewed the routine total chlorine testing log and the daily water treatment log. These logs included some signatures and initials that were illegible to both the surveyor as well as the bio-medical staff member. b. No signature legend was provided upon request c. During an interview conducted on 10/02/2025, the Facility Administrator acknowledged the importance of a signature page for ensuring accountability. The Administrator stated that he/she believed a signature page existed, but was unable to produce one upon request.”