Davita Takoma Park Dialysis

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 47759 Based on the overall finding of the survey, the facility’s governing body: 1) failed to ensure that the dialysis treatment provided to patients was in accordance with the written prescription; 2) 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; and 3) failed to ensure that a follow up comprehensive reassessment occurred within 3 months after the completion of the initial assessment. These failures placed the affected patients at potential risk of harm and denied patients the right to a minimum standard of medical care and resulted in a finding of the facility being out of compliance with the Condition for Coverage: Patient Assessment. Findings Included: 1. The facility’s governing body failed to ensure that the dialysis treatment provided to patients K, L, M, N, and O was in accordance with the written prescription. Cross Reference: Patient Assessment- Appropriateness of dialysis prescription (V0503) 2. The facility’s governing body failed to provide patient assessments within 30 days of 13 treatment days for Patients C, D, and I. Cross Reference: Patient Assessment Initial 30 Day Assessment (V0516) 3. The facility’s governing body failed to conduct 90 day follow up comprehensive reassessment within 3 months after the initial assessment for Patients C and I. Cross Reference: Patient Assessment Follow Up Reassessment (V0517)”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 47759 Based on record review and a staff interview, the facility’s governing body 1) failed to present documented evidence of a community based emergency training exercise conducted, and 2) failed to analyze the facility’s response to the facility based emergency training exercise conducted. This failure placed the patients and staff at potential risk of harm in case of an emergency. Findings included: On 02/20/2025 from 02:00 p.m. -02:15 p.m., review of the facility’s policy titled “Facility Emergency Management Plan (EMP)” (04-07-01) determined that page 27 under EMP training exercise stated, “The facility will conduct and/or participate in one (1) exercise to test the facility’s EMP at least annually, conducted on opposite years (one year full-scale exercise, next year facility based/exercise of choice).” Page 28 stated that the facility was to document: “c. evaluation of the plan. d. plan revisions required” On 02/19/2025 at 01:00 p.m., record review of the Facility and Community Emergency Preparedness/Emergency Management Plan binder revealed the following: 1. No documentation for 2023-2025 community emergency preparedness training records could be presented to the surveyor. 2. The facility based emergency preparedness training completed in 2024 did not have a complete evaluation form. According to the Facility Administrator, moving forward, he/she will make sure that the evaluation form will be completed.”

“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 02/20/2025 from 02:00 p.m. -02:15 p.m., review of the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01)determined that page 5 number 19 letter b stated, “Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.” Page 5 number 16 stated, “Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.” 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.” On 02/14/2025, from 10:15 a.m.-12:30 p.m., during observation of the treatment floor, the surveyor observed the following: 1. Medical tapes observed on the side tables of Stations #3, #5, #6, #15, #16, and #21. 2. Transparent tape/plastic tape wrapped around the “boom” part of the Hoyer lift. 3. Opened AmbuBag located at the bottom of the facility emergency cart. 4. Medication Preparation area adjacent to the clean sink with no splash guard in place. 5. Two Oxygen concentrators placed adjacent to the clean sink.”

“BACT OF H20-MEDICAL DIRECTOR RESPONSIBLE CFR(s): 494.40(a) 4.1.2 Bacteriology of water: med dir resp The facility medical director is responsible to ensure the manufacturer or supplier of a complete water treatment and distribution system demonstrates that the complete water treatment, storage, and distribution system is capable of meeting these requirements at the time of installation Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels. This Standard is not met as evidenced by: 47759 Based on observation, record review and a staff interview, the facility’s governing body failed to ensure that the medical director reviews and provides oversight of the results of all water and dialysate cultures and endotoxin levels. This failure placed the water system at risk for lack of oversight that may affect patient care. Findings included: On 02/20/2025 at 12:45 p.m., review of the “Medical Director Agreement” determined that page 25 Exhibit B Summary of Duties for a Medical Director of a DaVita Dialysis Facility under “Infection Control” stated, “Review and sign water culture and limulus amoebocyte lysate (LAL) test results monthly.” On 02/14/2025 at 10:00 a.m., during review of the water log report, the surveyor observed that the culture and endotoxin report from 07/2024 through 01/2025 had no signature from the Medical Director. During interviews with the surveyor, the Bio-Medical personnel stated that the facility needed a better process to ensure documentation of the Medical Director’s signature.”

“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 02/14/2025 between 08:10 a.m. -10:00 a.m., during observations of the water room and the storage room, the surveyor observed that the booster pump, a component of the water system, was blocked off by several boxes as well as cushions placed above the water line. Interviews with the bio-medical staff revealed that the boxes impeded the staff’s ability to access the booster pump in case of an emergency.”

“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, staff interview, and record review, the facility ’ s governing body failed to maintain the facility building in a manner that promoted patient and staff safety as evidenced by failer to provide a means of egress that remained unobstructed in case of fire or other emergency. This failure placed patients and staff at potential risk of harm in case of an emergency. Findings Included: Per the requirement of Occupational Safety and Health Administration (OSHA) at 29 CFR 1910.37(a)(3), “Exit routes must be free and unobstructed. No materials or equipment may be placed, either permanently or temporarily, within the exit route.” On 02/20/2025 from 02:00 p.m. -02:15 p.m., review of the facility’s policy titled “Facility Emergency Management Plan (EMP)” (04-07-01) page 13 number 5 stated “Evacuation routes shall be, as per local fire code: ...e. The egress area must remain clear at all times.” On 02/13/2025 at 12:25 p.m., the surveyor observed two dialysis chairs, a dolly, several boxes, and a traffic cone blocking the hallway towards the back exit. On 02/14/2025, at 10:10 a.m., interviews with the bio-medical staff stated that the hallway should be clear at all times.”

“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: 47759 Based on observations and a staff interview, the facility’s governing body failed to ensure that all supplies on the treatment floor were appropriate to use and were within its designated timeframe. This failure placed the affected patients at potential risk of harm. Findings included: On 02/20/2025 from 02:00 p.m. - 02:15 p.m., review of the facility’s policy titled “Medication Policy” (Policy 1-06-01) determined that page 5 number 32 stated: “Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of.” On 02/14/2025 at 11:20 a.m., during observations and inspection of supplies in the clinical treatment room, the surveyor observed four expired Cefazolin vials with a lot number 2004KFMBKE, expiration date: 01/2025. The Clinical Coordinator verified the surveyor’s finding and immediately discarded the items upon discovery.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 47759 Based on observations, staff interview, and record review, the facility ’ s governing body failed to provide a means of egress that remained unobstructed in case of fire or other emergency. This failure placed patients at potential risk of harm in case of an emergency. Findings Included: According to NFPA 1 Section 14.4.1, the means of egress must remain unobstructed in case of fire or other emergency. On 02/20/2025 from 02:00 p.m. -02:15 p.m., review of the facility’s policy titled “Facility Emergency Management Plan (EMP)” (04-07-01) page 13 number 5 stated “Evacuation routes shall be, as per local fire code: ...e. The egress area must remain clear at all times.” On 02/13/2025 at 12:25 p.m., the surveyor observed two dialysis chairs, a dolly, several boxes, and a traffic cone blocking the hallway towards the back exit. On 02/14/2025, at 10:10 a.m., interviews with the Bio-Med stated that the hallway should be clear at all times.”

“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, observations, and staff interviews, the facility’s governing body failed to ensure that the dialysis treatment provided to patients was in accordance with the written prescription. This failure placed the affected patients at potential risk of harm and denied patients their rights to a minimum standard of medical care. This was a repeat finding from 2021 recertification survey. Findings Included: On 02/20/2025 from 02:00 p.m. -02:15 p.m., review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” (Policy 1-03-08) determined that page 2 number 3 stated, “The prescription components are confirmed by a licensed nurse 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: ...c. Target Weight ...d. Ultrafiltration Rate (UFR) and Maximum UFR ...f. Blood flow rate ... g. Dialysate flow rate.” Page 4 number 10 stated, “If the dialysis prescription is not being met ...the reason will be documented and the licensed nurse informed.” Number 12. stated, “The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status.” Number 13 stated, “All findings, interventions and patient response will be documented in the patient’s medical record.” Under “Abnormal Findings,” the policy stated that “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.” Those abnormal findings include, 1. “If the patient is above or below 1kg from the target weight.” 2. “If unable to obtain patient weight, the nurse is to contact physician for orders ....Removal goal not to exceed maximum ordered by physician” Between 02/18/2025-02/19/2025, the surveyor observed the following: 1. Ultrafiltration Rate (UFR): On 02/18/2025, the surveyor, along with the manager of clinical services (MCS) audited 18 dialysis machines on the treatment floor and compared the set ultrafiltration rate (UFR) in comparison to each patients ’ prescribed maximum ultrafiltration rate. Of the 18 treatments, 5 had exceeded the maximum ultrafiltration rate. (Patients K, L, M, N, and O). Interviews with the Manager of Clinical Services (MCS) revealed that per policy, Staff #1 should first notify the provider of the finding and ask for an order to modify the maximum ultrafiltration rate. According to the MCS, Staff #1 did not follow policy. To confirm this finding, the surveyor interviewed Staff #2 about Patient K. The surveyor asked if Staff #1 had asked Staff #2 if he/she could exceed the maximum UFR in relation to the prescribed order. According to Staff #2, he/she was not informed and immediately assessed the patient. a. On 02/19/2025, to further confirm this finding, the surveyor asked for the treatment flowsheet of the 5 patients (Patients K, L, M, and O). Review of the 5 treatment flowsheet did not contain supporting documentation of provider notification or modified orders by the provider. This information was verified by the Clinical Coordinator and the Facility Administrator who both agreed with the surveyor’s finding. b. Examples of observations are listed below: i . Patient K was ordered a maximum UFR of 13 mL/kg/hr. Based on the treatment flowsheet, the UFR set was 16.3 mL/kg/hr. Per documentation, the RN had verified that the “patient’s prescription matches what is currently being delivered during the dialysis treatment.” No notes were found explaining why the prescribed orders were not followed. ii. Patient O was ordered a maximum UFR of 13 mL/kg/hr. Based on the treatment flowsheet, the UFR set was 17.7 mL/kg/hr. Per documentation, the RN had verified that the “patient’s prescription matches what is currently being delivered during the dialysis treatment.” No notes were found explaining why the prescribed orders were not followed. iii. Patient N was ordered a maximum UFR of 13 mL/kg/hr. Based on the treatment flowsheet, the UFR set was 15.9 mL/kg/hr. Per documentation, the RN had verified that the “patient’s prescription matches what is currently being delivered during the dialysis treatment.” No notes were found explaining why the prescribed orders were not followed. 2. Blood Flow Rate (BFR): On 02/19/2025, review of the selected patients’ treatment flowsheet revealed the following: a. Of the 24 treatment flowsheets audited, 10 treatment flowsheets did not follow the prescribed Blood Flow Rate (BFR) or Dialysate Flow Rate (DFR). Review of the 10 treatment flowsheets did not contain supporting documentation of provider notification or modified orders by the provider. This information was verified by the Clinical Coordinator who agreed with the surveyor’s finding. b. Examples of the observations are listed below: i. On treatment date 02/08/2025, Patient B was prescribed a Dialysis Flow Rate (DFR) of 500 mL/min. From 03:31 p.m. -05:51 p.m., the documented DFR was 0 mL/min. Per documentation, the RN had verified that the “patient’s prescription matches what is currently being delivered during the dialysis treatment.” No notes were found explaining why the prescribed orders were not followed. ii. On treatment date 01/28/2025, Patient D was prescribed a DFR of 500 mL/min. From 11:20 a.m. -01:12 p.m., the documented DFR was 0 mL/min. Per documentation, the RN had verified that the “patient’s prescription matches what is currently being delivered during the dialysis treatment.” No notes were found explaining why the prescribed orders were not followed. iii. On treatment date 01/22/2025, Patient H was prescribed a BFR of 400 mL/min. From 02:41 p.m. -06:15 p.m., the documented BFR was 300 mL/min. Per documentation, the RN had verified that the “patient’s prescription matches what is currently being delivered during the dialysis treatment.” No notes were found explaining why the prescribed orders were not followed. 3. Review of the survey report conducted on 09/2021 revealed a similar finding.”

“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 02/20/2025 from 02:00 p.m. -02:15 p.m., review of the facility’s policy titled “Interdisciplinary team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01) determined that 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 02/14/2025 between 01:00 p.m. -02:00 p.m., during record review of the selected patients’ Plan of Care (PoC), the surveyor observed the following: 1. Patient C, admitted 03/2024, had his/her PoC completed on 05/21/2024, approximately 1 month past the due date. 2. Patient D, admitted on 05/2023, had his/her PoC completed on 02/02/2024, approximately 9 months past the due date. 3. Patient I, admitted 08/2024, had his/her PoC completed on 10/2024, approximately 1.5 months past the due date.”

“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: 47759 Based on observations and record review, the facility’s governing body failed to ensure that a follow up comprehensive reassessment occurred within 3 months after the completion of the initial assessment. This failure placed the affected patient at potential risk of harm and denied patients right to a minimum standard of care. Findings Included: On 02/20/2025 between 02:00 p.m. -02:15 p.m., review of the facility’s policy titled “Interdisciplinary team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01) determined that page 2 number 5 stated, “A follow up 90 day reassessment will be completed to evaluate patient ’ s status and provide information to adjust the patient’s plan of care.” Page 4 number 15 stated, “If the documents are adequate and the patient is stable, the Interdisciplinary Team may conduct a re-assessment within 3 months of admission.” On 02/14/2025 between 01:00 p.m. -02:00 p.m., during record review of the selected patients’ Plan of Care (PoC), the surveyor observed the following: 1. Patient C, a transfer patient admitted on 03/14/2024 had his/her 90 day PoC completed on 10/17/2024, approximately 3 months past the due date. 2. Patient I, assessed on 10/2024, had his/her 90 day PoC completed on 02/13/2025, approximately 1 month past the due date.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of the facility’s policies and procedures, the medical director failed to ensure that the staff members adhered to their own policies and procedures. This failure posed a potential risk of safety to the patients, and denied patients their rights to a minimum standard of medical care Findings Included: On 02/20/2025, review of the facility’s “Medical Director Agreement,” page 25, Exhibit B: Summary of Duties for a Medical Director of a DaVita Dialysis Facility, determined that it stated under “Physician Duties”: “Participate in development, implementation, review, and approval of (and adherence by center providers to) all Center policies and procedures ....Center staff education, training, and performance.” The Medical Director’s signature on the “Medical Director Agreement” and interviews conducted on 02/20/2025 at 01:00 p.m. both confirmed awareness of the duties outlined in the agreement. 1. On 02/19/2025, review of the Facility and Community Emergency Preparedness/ Emergency Management Plan binder revealed failure to 1. Maintain documentation of the emergency training exercise conducted and 2. Analyze the facility’s response to the emergency training exercise conducted. This finding failed to meet the facility’s policy titled, “Facility Emergency Management Plan” (4-07-01). 2. On 02/14/2025, observations of the treatment floor revealed failure to maintain a sanitary environment at all times. This finding failed to meet the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01). 3. On 02/14/2025, observations of the treatment floor revealed failure to ensure that all supplies essential to the delivery of appropriate dialysis treatment were not expired. This finding failed to meet the facility’s policy titled “Medication Policy” (Policy 1-06-01). 4. On 02/13/2025, observations of the treatment floor revealed failure to provide a means of egress that remained unobstructed in case of fire or other emergency. This finding failed to meet the facility’s policy titled, “Facility Emergency Management Plan (EMP)” (04-07-01). 5. Between 02/18/2025-02/19/2025, staff interviews, observations and record review revealed failure to ensure that the dialysis treatment provided to patients was in accordance with the written prescription. This finding failed to meet the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment.” (Policy 1-03-08). 6. On 02/14/2025, record review revealed failure to ensure that 1. 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 2.a follow up comprehensive reassessment occurred within 3 months after the completion of the initial assessment. This finding failed to meet the facility’s policy titled, “Interdisciplinary team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01).”

“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, 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 included: 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....Staffing Exception Reporting. (a) ... The report shall include, at a minimum: (i) The date and shift of the exception; (ii) A description of the emergency staffing situation;(iii) Actions taken in response; and (iv) Any measures taken to ensure the center’s future compliance. (b) The exception reporting protocol shall be included in the center’s quality assurance process. On 02/19/2025 at 2:00 p.m., review of the facility’s staffing report from 01/27/2025 through 02/15/2025 revealed that staffing ratios did not meet the requirements on the following dates and shifts. 1. 01/27/2025 -Shift 1 2. 01/31/2025 -Shift 1 3. 02/03/2025 -Shift 1 4. 02/04/2025 -Shift 2 5. 02/08/2025 -Shifts 1 and 2”