Davita Howard County Dialysis

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 47759 Based on the overall findings of the survey, it was determined that the facility’s governing body failed to: 1) provide treatment in accordance with the written prescription, and 2) conduct comprehensive monthly assessments for each unstable patient. 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 was in accordance with the written prescription. See Cross Reference: Patient Assessment- Appropriateness of dialysis prescription (V0503). 2. The facility’s governing body failed to ensure conduction of comprehensive monthly assessments for each unstable patient. See Cross Reference: Patient Assessment-Frequency Reassessment-Unstable every month (V520).”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 47759 Based on the overall finding of the survey, the facility’s governing body failed to 1) ensure that the implementation of the initial plan of care began within 30 days after admission to the dialysis facility or 13 hemodialysis sessions beginning with the first outpatient dialysis session; and 2) adjust the affected patient ’ s plan of care when a patient was unable to achieve the desired outcome. These failures denied patients their right to have individualized care and 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 Plan of Care. Findings Included: 1. The facility’s governing body failed to ensure that the implementation of the initial plan of care began within 30 days after admission to the dialysis facility or 13 hemodialysis sessions beginning with the first outpatient dialysis session. . See Cross Reference: Plan of Care-Initial Implementation (V0557). 2. The facility’s governing body failed to adjust the affected patient’s plan of care when a patient was unable to achieve the desired outcome. See Cross Reference: Plan of Care-Outcome not achieved-Adjust Plan of Care (V0559).”

“CFC-PERSONNEL QUALIFICATIONS CFR(s): 494.140 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 direct care staff had their competencies evaluated before being assigned to patient care; and 2) failed to ensure that the facility had a dedicated nursing manager. These failures denied patients their right to receive care by qualified individuals and increased the risk of substandard level of care in the facility. As a result, the facility was found to be out of compliance with the Condition for Coverage: Personnel Qualifications. Findings Included: 1. The facility’s governing body failed to ensure all direct patient care teammates completed the training to meet competency standards. Cross-reference to tag V0681. 2. The facility’s governing body failed to ensure that the facility had a dedicated nurse manager/Clinical Coordinator who was responsible for delivery of nursing services in the facility and failed to demonstrate that active recruitment efforts for a nurse manager/Clinical Coordinator were closely monitored, discussed, and evaluated in the facility. Cross-reference to tag V0684.”

“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 failed to: 1) maintain accurate documentation of the emergency training exercise conducted; and 2) analyze the facility’s response to the emergency training exercise conducted. This failure placed the patients and staff at potential risk of harm in case of an emergency. Findings Included: On 01/06/2025, from 01:00 p.m. -03:00 p.m., during record review of the facility’s policy titled “Facility Emergency Management Plan” (4-07-01), page 5 number 5 stated: “the Facility Administrator, or designee, is responsible for ...c. Collaboration with the Medical Director to lead the development and implementation of the facility Emergency Management Plan, including review and revision of existing policies and processes, participation and evaluation of emergency preparedness drills, planning in advance of anticipated (e.g. weather-related) events and responding to and managing unexpected events.” On page 33, the surveyor observed that the facility was provided a form titled “Facility Emergency Drill Exercise Evaluation.” However, the evaluation form was not utilized by the facility in any of the emergency preparedness drills provided. On 12/31/ 2024, at 09:30 a.m., record review of the Emergency Preparedness binder revealed the following: 1. Emergency Preparedness Training completed on 12/12/2023 was completed in another facility and only involved one personnel from this facility. 2. Emergency Preparedness Training completed on 07/10/2024 did not have evaluation analyzing the facility’s response to the emergency training exercise conducted. 3. A third Emergency Preparedness Training was provided to the surveyor with no date of completion nor details as to whether the steps were completed according to the guideline. The surveyor was provided a blank form of policy 04-07-07. There were no evaluations included in the training record. On 12/31/2024, Interviews with the Facility Administrator stated that moving forward, an evaluation will be recorded on the Emergency Preparedness Training.”

“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, record review, and a staff interview, the facility’s governing body failed to ensure that supplies were stored in a manner that maintained their integrity. This failure placed the patients and staff at potential risk for exposure to blood-borne pathogens and other infectious diseases. Findings Included: On 01/06/2025 from 01:00 p.m. -03:00 p.m., record review of the facility’s policy titled “Infection Control for Dialysis Facilities” (01-05-01) determined that page 2 number 8 stated: “Supplies will be stored in a manner that maintains their integrity ...Supplies will not be opened until time of use ....Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used.” On 12/30/2024 at 11:10 a.m., during observations on the treatment floor, the surveyor observed the following items located inside the drawers near Station #13: 1. Opened 0.9% Sodium Chloride (NaCl) 250 mL (NDC: 0338-0049-02) 2. Opened 0.9% Sodium Chloride (NaCl) 10 mL flush -Lot #4185556 3. Opened Fistula needle 17 G -Lot #21B211 4. Opened Fistula needle 16 G -Lot #24C176 On 12/30/2024 at 11:16 a.m., during an interview, Staff #7 stated that the items found should have been disposed of.”

“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: 47759 Based on observations and record review, the facility’s governing body failed to ensure that the non disposable items taken to patient stations were cleaned and disinfected before being returned to their designated “clean area”. This failure placed the patients and staff at potential risk for exposure to blood-borne pathogens and other infectious diseases. Findings Include: On 01/06/2025 from 01:00 p.m.-03:00 p.m., review of the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01) determined that page 4 number 14 stated, “Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If the item cannot be cleaned and disinfected it will be dedicated for use on a single patient. “ On 12/30/2024 during observation of the treatment floor, the surveyor observed the following: 1. At 09:42 a.m., during disinfection of Station #22, the surveyor observed that Staff #1 did not disinfect the exterior portion of the used acid jug prior to returning the item to its designated area. 2. At 10:42 a.m., during disinfection of Station #1, the surveyor observed that Staff #4 did not disinfect the exterior portion of the used acid jug prior to returning the item to its designated area.”

“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 record review, the facility’s governing body failed to ensure that the clinical staff maintained an environment that enhances safe handling, storage, and disposal of potentially infectious waste. This failure placed the staff and patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings Included: Based on the Centers for Disease Control and Prevention guidance, “If used dialyzers and blood tubing are transported out of the station before being discarded, they should be transported in a manner that prevents any leakage.” 1. On 12/30/2024, during observations on the clinical treatment floor, the surveyor observed the following: a. At 09:40 a.m., Staff #1 carried the used blood line tubing from Station #3 to the waste container located near Station #4 crossing Station #4. b. At 09:57 a.m., Staff #2 carried the used blood line tubing from Station #2 to the waste container located near Station #1 crossing Station #1. 2. On 01/07/2025, at 10:15 a.m., Staff #9 carried the used blood line tubing from Station #1 to the waste container located near Station #3 crossing Stations #2 and #3.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 47759 Based on a staff interview and record reviews, the facility’s governing body failed to ensure Hepatitis B routine testing was completed for all patients and staff members. This failure placed patients and staff at risk of contracting infectious diseases. Findings Included: On 01/06/2025, from 01:00 p.m. -03:00 p.m., during record review of the facility’s policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (Policy 1-05-02), Page 3 stated that susceptible patients with X<10 Hepatitis B Antibody (HBsAb) must have Hepatitis B Antigen (HBsAg) testing done monthly. According to the Centers for Disease Control and Prevention (CDC), although the incidence of Hepatitis B virus (HBV) infection is low among chronic hemodialysis patients, preventing transmission depends on timely detection of patients converting from HBsAg negative to HBsAg positive and rapid implementation of isolation procedures before cross-contamination can occur. 1. On 12/31/2024 at 11:20 a.m., during record review of the facility’s Hepatitis B Audit Report, the surveyor observed that Patient A, a susceptible patient with a HBsAB <10 that resulted in October 2024 did not have a HBsAg done monthly. The Facility Administrator immediately asked the provider for a HBsAg testing order. 2. On 01/07/2025, at 11:00 a.m., review of the personnel file revealed that 5 out of the 13 (38%) of the staff members did not have documentation that showed hepatitis B result status. (Staff #3, #9,#10, #11,and #12)”

“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 Code of Maryland Regulations (COMAR) at 10.01.21.04B states the following: “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.” Additionally, COMAR 10.01.21.04E requires: 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 01/02/2025 from 08:00 a.m. -12:00 p.m., during review of the selected patients’ medical records, the surveyor observed the following: 1. Patient B did not have a page 2 copy of the MOLST form. 2. Patient C did not have his/her name printed on the MOLST form. 3. Patient D did not have a MOLST form. 4. Patient F did not have a MOLST form. At 12:00 p.m., Staff #6, along with the surveyor, confirmed the surveyor’s findings above.”

“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. Findings Included: According to the National Kidney Foundation, the ultrafiltration rate (UFR) is the rate set on the dialysis machine for removing excessive fluid from a dialysis patient. On 01/06/2025 from 01:00 p.m.-03:00 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 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: ...d. Ultrafiltration Rate (UFR) and Maximum UFR.” Page 4 number 10 stated, “If the dialysis prescription is not being met, the reason will be documented and the licensed nurse informed. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record.” Page 5 under fluid status stated, “Removal goal not to exceed maximum ordered by physician” On 01/02/2025 from 08:00 a.m. -12:00 p.m., review of 72 patients’ “Fluid and Blood Pressure Management Report” revealed that at least 50% of treatments for 6 patients (Patient A, D, F, G, H, and I) for the month of December exceeded the prescribed maximum UFR. At 12:05 p.m., interviews with Staff #6 confirmed the surveyors’ findings and stated that based on record review of the patients’ medical records, no documentation recorded demonstrated that the patients’ prescriptions had been modified by their providers. According to Staff #6, per policy, Staff members should abide by the providers ’ orders and should not exceed the prescribed maximum UFR without an order.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to ensure conduction of comprehensive monthly assessments for each unstable patient who had extended or frequent hospitalizations and significant changes in psychosocial needs This failure denied patients their right to have individualized care. Findings Included: On 01/06/2025 from 01:00 p.m. -03:00 p.m., review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” determined that page 2 number 7 stated: “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted:... At least monthly for unstable patients including,...extended or frequent hospitalizations ...significant changes in psychosocial needs.” On 01/02/2025, from 08:00 a.m. -12:00 p.m., record review of Patient D ’ s medical records revealed that the patient had a hospitalization that lasted for more than 15 days which according to Staff #6, was considered an “extended hospitalization” and should have been made unstable immediately after the patient’s admission date of 11/17/2023. Record review revealed that Patient D ’ s plan of care was not completed until 03/04/2024 which was 4 months after the admission date. On 01/02/2025, interviews with Staff #6 revealed that on 06/2024, Patient D was made unstable, and has not been made stable as of 12/2024. Record review revealed incomplete monthly plan of care assessments for this patient in the months of August 2024 and October 2024.”

“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 01/06/2025 from 01:00 p.m. -03:00 p.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) determined that page 2 number 5 stated: “Perform inspection, auscultation and palpation on entire length of access. Determine the presence of bruit and thrill.” 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 12/30/2024, during observation of AVF/AVG treatment initiation, the surveyor observed the following: 1. At 10:30 a.m., during access assessment, the surveyor observed that Staff #1 did not use a stethoscope to listen to the patient (Sitting in Station #12)’s access. The surveyor also observed that Staff #1 disinfected the patient (Sitting in Station #12)’s access for 15 seconds. 2. At 10:55 a.m., during access assessment, the surveyor observed that Staff #1 did not use a stethoscope to listen to the patient (Sitting in Station #4’s access. The surveyor also observed that Staff #1 disinfected the patient (Sitting in Station #4)’s access for 15 seconds. On 01/07/2025, at 10:05 a.m. during access assessment, the surveyor observed that Staff #8 did not use a stethoscope to listen to the access of the patient sitting in Station #12. The surveyor also observed that Staff #8 disinfected the access of the patient sitting in Station #12 for 10 seconds.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 47759 Based on record review, the facility’s governing body and interdisciplinary team (IDT) failed to ensure that the implementation of the initial plan of care began within 30 days after admission to the dialysis facility or 13 hemodialysis sessions beginning with the first outpatient dialysis session. This failure placed the affected patients at potential risk of harm and denied patients their rights to a minimum standard of care. Findings included: On 01/06/2025 from 01:00 p.m. -03:00 p.m., review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care “ (Policy 1-13-01) determined that page 4 number 10 stated, “ An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” On 01/02/205 from 08:00 a.m. -12:00 p.m., during review of 6 selected patients’ 30 day PoC, the surveyor observed that 3 out of the 6 plan of care reviewed (50%) were not completed within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis). The review demonstrated the following: 1. Patient A, admitted on 04/26/2024, had his/her 30 day plan of care assessment completed on 06/24/2024, which was approximately 1 month late. 2. Patient D, admitted on 11/17/2023, had his/her 30 day plan of care assessment completed on 03/04/2024, which was approximately 2 months late. 3. Patient E, admitted on 06/12/2023, had his/her 30 day plan of care assessment completed on 02/05/2024, which was approximately 6 months late.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to adjust the affected patient’s plan of care when a patient was unable to achieve the desired outcome. This failure denied patients their right to a minimum standard of care. Findings Included: On 01/06/2025 from 01:00 p.m. -03:00 p.m., review of the facility’s policy titled” Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 12-16-01) determined that: 1. Page 1 number 2 stated, “The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient ’ s treatment plan and expectations for care.” 2. Page 2 number 8 stated, “The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patients’ needs, as identified by the comprehensive assessment and changes in the patient ’ s condition and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient’s plan of care will be consistent with current evidenced-based professionally accepted clinical practice standards.” 3. Page 4 number 13 stated, “if the expected outcome is not achieved, the interdisciplinary team (or individual IDT member) will adjust the patient ’ s plan of care to achieve the specified goal. When a patient is unable to achieve the desired outcomes, the team will: -Adjust the plan of care to reflect the patient’s current condition -Document in the patient’s medical record the reason why the patient was unable to achieve the goals. -Implement plan of care changes to address the issues identified. On 01/02/2024, from 08:00 a.m. -12:00 p.m., review of Patient D’s medical records and interviews with Staff #6 revealed the following: 1. According to Staff #6, plan of care documented on 06/2024 did not provide details that could be “adequately measured.” 2. According to Staff #6, plan of care documented on 07/2024, 09/2024, and 12/2024 was “not specific.” There was no documentation explaining the reason why the patient was unable to achieve goals nor plans to change the issues identified. 3. According to the plan of care documented on the dates: 06/2024, 07/2024, 09/2024, and 12/2024 “Patient displays effective coping skills and verbalizes understanding and ability to follow treatment regimen for preferred modality. The patient has adequate resources to meet psychosocial needs.” a. Interviews with the Social Worker, Registered Dietician, Facility Administrator, and Staff #6 revealed that this documentation was not accurate. 4. According to the plan of care documented on 12/2024, under “fluid and blood pressure,” Patient D’s blood pressure was within range. a. Review of Patient D’s pre and post treatment blood pressures throughout the record revealed abnormal ranges. Patient D’s systolic ranged from 170s-228 mmHg. On 01/08/2024, at 11:00 a.m., upon reviewing the unstable plan of care documentation of Patient D, the Manager of Clinical Services (MCS) stated that the reason for”unstable” was not specific nor measurable.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. 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 facility staff discussed problems that had been identified in the facility, taking into account the prevalence, severity, and prioritizing improvement activities. This failure compromised the opportunity to improve the quality of care being provided at the facility and denied patients’ their rights to a minimum standard of medical care. Findings Included: On 01/08/2025, at 11:30 a.m., record review of the facility’s medical record (FHR) also known as Quality Assurance and Performance Improvement (QAPI) from June through November revealed no documentation of the following: 1. Facility’s need for a Clinical Coordinator a. On 01/08/2025 at 11:45 p.m., Interviews with the manager of clinical services (MCS) stated that discussions regarding the need for a Clinical Coordinator should have been documented on the FHR. 2. Plan of Care oversight 3. Delayed Blood Stream Infection data 4. Hepatitis B status oversight 5. Personnel file oversight 6. Medical Orders for Life-Sustaining Treatment (MOLST) form oversight 7. Consumer Assessment of Healthcare Providers and Systems (CAHPS) result oversight”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to ensure all direct patient care teammates completed the training to meet competency standards. This failure denied patients their rights to a minimum standard of medical care. Findings Included: On 01/07/2025, at 11:00 a.m., during review of the facility’s personnel file, the surveyor observed that 2 out of the 13 direct patient care teammates (Staff #9 and #13) did not have documentation of completed competency/skills check. According to the Facility Administrator, the facility will complete training immediately and ensure completion of the necessary documentation for the two staff members.”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 47759 Based on observations, multiple staff interviews, and record reviews, the facility’s governing body failed to ensure that the facility had a dedicated nurse manager/Clinical Coordinator who was responsible for delivery of nursing services in the facility and failed to demonstrate that active recruitment efforts for a nurse manager/Clinical Coordinator were closely monitored, discussed, and evaluated in the facility. This failure resulted in an increased risk of patients receiving inadequate care due to lack of consistent oversight of dialysis and nursing services provided in the facility. Findings Included: According to the Code of Maryland Regulations (COMAR) at 10.30.02.04C, “1. Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility that: a). Is a full time employee of the facility.” 1. Interviews with the Staff #2, Registered Dietician, Facility Administrator, and Staff #6 throughout the course of the survey revealed that the facility did not have a designated Clinical Coordinator/Nurse Manager who was in charge of overseeing the clinical operations of the facility. The Clinical Coordinator’s position was considered vacant. While the surveyor was told that there were other staff members from this facility and sister facility covering for duties of the Clinical Coordinator, there was no documented evidence to support the stated arrangement. 2. On 01/07/2024 at 11:00 a.m., during review of Facility Health Record (FHR), also known as Quality Assurance and Performance Improvement (QAPI) and Governing Body documents, the surveyor requested for all documentation that discussed the facility’s need for a Clinical Coordinator and documentation that showed active recruitment efforts to be provided. The Facility Administrator provided the surveyor a copy of the facility’s governing body document with the date of December 18, 2024 and was not able to produce documentation of active recruitment efforts prior to December 18, 2024. 3. During interviews with different Interdisciplinary team members, the surveyor was given different times in which the position for Clinical Coordinator had been vacant. a. According to Staff #2 and the Medical Director, the Clinical Coordinator position had been vacant for approximately a year. b. According to the Registered Dietician, the Clinical Coordinator position had been vacant for approximately 3 years. c. According to Staff #8, the Clinical Coordinator position had been vacant for approximately 8 months. d. According to the Facility Administrator, the Clinical Coordinator position had been vacant for approximately 3 months. 4. Additional interviews with the staff members were as follows: a. On 01/02/2025, at 12:00 p.m., during an interview, Staff #6 stated that the facility needs a “permanent” and “full time” Clinical Coordinator and not a covering Clinical Coordinator, and that the patients deserved to have “continuity of care.” b. On 01/08/2025, at 12:00 p.m., during an interview, Staff #2 stated that the facility needed a Clinical Coordinator. At times, Staff #2 was delegated to attend QAPI meetings; however, he/she could not stay during the QAPI meeting due to being a charge nurse on the treatment floor. c. On 01/08/2025, at 10:30 a.m., during an interview, Staff #8 stated that the facility needed a Clinical Coordinator in order to have “continuity of care” and to address “clinical needs” of the facility.”

“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 01/07/2025, during record review of the facility’s “Medical Director Agreement” under “Physician Duties,” page 40 number 40 letter X stated, “In coordination with the Facility Administrator, assure that patient care policies and procedures are followed by each person who treats patients.” The Medical Director’s signature on the “Medical Director Agreement” and interviews conducted on 01/07/2025 at 12:00 p.m. both confirmed awareness of the duties outlined in the agreement. 1. On 12/31/2024, review of the facility’s Emergency Preparedness binder revealed failure to 1. Maintain accurate 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 12/30/2024, observations of the treatment floor revealed failure to ensure that supplies were stored in a manner that maintains their integrity. In addition, On 12/30/2024, observations of the treatment floor revealed failure to ensure that the non disposable items taken to patient stations were cleaned and disinfected before being returned to their designated “clean area”. These findings failed to meet the facility ’ s policy titled, “Infection Control for Dialysis Facilities” (Policy 1-05-01). 3. On 01/06/2025, review of the facility’s “Vaccination and Surveillance Report” revealed failure to ensure Hepatitis B routine testing was completed for all patients and staff members.This finding failed to meet the facility’s policy titled “ Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance. “ 4. On 01/02/2025, review of Patient D ’ s medical records revealed failure to ensure conduction of comprehensive monthly assessments for unstable patient including ...extended or frequent hospitalizations and significant changes in psychosocial needs. This finding failed to meet the facility ’ s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01). 5. On 12/30/2024, observations of the treatment floor revealed failure to ensure that the clinical staff members complied with the facility’s access assessment and cannulation protocol. This finding failed to meet 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). 6. On 01/02/2025, review of the selected patients ’ 30 day Plan of Care revealed failure to ensure that the implementation of the initial plan of care began within 30 days after admission to the dialysis facility or 13 hemodialysis sessions beginning with the first outpatient dialysis session. In addition, on 01/02/2025, review of Patient D ’ s medical records revealed failure to adjust the affected patient ’ s plan of care when a patient is unable to achieve the desired outcome. These findings failed to meet the facility ’ s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 12-16-01). 7. On 01/02/2025, review of the selected patients’ initial nursing assessment revealed failure to ensure conduction of initial nursing assessments prior to the initiation of their first treatment at the facility. The surveyor observed that 5 out of 6 (83%) patients reviewed did not have an initial nursing assessment completed. This finding failed to meet the facility ’ s policy titled, “Policy and Procedure: Initial Patient Nursing Assessment for New Patients” (Policy 1-03-07). 8. On 01/02/2025, review of the selected patients ’ treatment flowsheets and “Fluid and Blood Pressure Monitoring Report” 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).”

“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 proper documentation of the daily machine disinfection log. This failure placed the facility’s water system at potential risk of contamination Findings Included: On 01/06/2025 from 01:00 p.m. -03:00 p.m., review of the facility’s policy titled “B Braun Dialog Dialysis Delivery System Cleaning and Disinfection Policy” (Policy 1-15-07) determined that page 1 and 2 stated that each treatment day, after each patient use and at the end of the day, the staff must use “50% Citric Acid and Thermal Disinfection.” If the delivery system has not come in contact with bicarb concentrate, thermal disinfection is acceptable.” On 01/06/2025, Review of the “B Braun Dialysis Delivery System Clean and Disinfect Log” revealed the following: On 11/07/2024, there was no documentation that demonstrated disinfection of machines 1 through 27. On 11/13/2024, there was no documentation that demonstrated disinfection of machines 5 through 27. During an interview, the Bio-Medical personnel stated that moving forward, an audit will be conducted on a monthly basis to ensure staff compliance with the stated policy.”