Davita Laurel Lakes 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, 2.) provide individualized nutritional needs assessments for patients, and 3.) provide initial comprehensive patient assessments within latter of 30 calendar days or 13 treatment sessions. 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 provide treatment in accordance with the written prescription for Patients A and B. See Cross Reference: Patient Assessment -Appropriateness of Dialysis (V0503) 2. The facility’s governing body failed to provide individualized nutritional needs assessment of Patient C. See Cross Reference: Patient Assessment-Registered Dietician-Nutritional Status (V0509) 3. The facility’s governing body failed to provide patient assessments within 30 days of 13 treatment days for Patient C. See Cross Reference: Patient Assessment-Initial-30 Day Assessment (V0516)”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 47759 Based on record reviews and a staff interview, the facility’s governing body failed to ensure that all susceptible patients were offered Hepatitis B Vaccination. This failure placed the affected susceptible patients at potential risk of exposure to blood borne pathogens. Findings Included: On 10/21/2024 from 11:10 a.m.-11:25 a.m., review of the facility’s policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” (Policy 1-05-02) determined that page 2 stated that for patients with antibody of less than 10, next step is to “Offer vaccination series.” Page 3 number 10 stated, “The patient is provided the Vaccination Information Sheet (VIS) and a consent form (included in the Patient Registration Packet found in Reggie). The patient will consent to the vaccination or will decline. The completed form will be kept in the patient’s health record.” On 10/18/2024 at 09:45 a.m., during record review of the facility’s “Vaccination and Surveillance Report,” the surveyor observed that 6 out of the 23 (26%) susceptible patients audited had “no current hepatitis B vaccination documentation.” On 10/21/2024 at 11:05 a.m., the surveyor requested for the vaccination consent or declination form for the 6 susceptible patients (Patients A, G, I, J, K, and L). No consent or declination form for Hepatitis B Vaccine could be presented by the Facility Administrator.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 47759 Based on observations, the facility’s governing body failed to ensure that the correct address of the State Survey Agency was prominently displayed where it can be easily seen and read by the patients. This failure denied the patients their rights. Findings Included: On 10/16/2024, at 09:00 a.m., during a flash tour of the facility, the surveyor observed that the complaint poster was outdated. According to the poster, the address written for the Office of Health Care Quality was “55 Wade Avenue, Catonsville, MD 21228.” The correct information for the Office of Health Care Quality is 7120 Samuel Morse Drive, Second Floor, Columbia, MD 21046-3422.”

“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 10/17/2024 from 01:30 p.m.-02:00 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 stated, “10. 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.” 1. On 10/17/2024 at 12:30 p.m., during the review of Patient A’s fluid and management report, the surveyor observed the following: a. On treatment dates 09/06/2024 through 10/16/2024, based on record review of Patient A’s treatment flowsheets, the ordered target weight was 51 kg and the ordered maximum ultrafiltration rate (UFR) was 13 mL/kg/hr. Based on this information, the calculated UFR was 663 mL/kg/hr. b. Review of Patient A’s treatment flowsheet from 09/18/2024 through 10/16/2024 revealed noncompliance with the prescribed maximum UFR. The review demonstrated that 11 out of 12 (91%) treatment dates audited exceeded the maximum UFR prescribed. See documented examples below: i. On 10/14/2024 the documented UFR from 04:44 p.m. - 07:03 p.m. was 910 mL/kg/hr. ii. On 10/11/2024 the documented UFR from 04:26 p.m. - 07:19 p.m. was 1020 mL/kg/hr. iii. On 10/04/2024 the documented UFR from 03:51 p.m. - 06:39 p.m. was 1020 mL/kg/hr. iv. On 09/20/2024, the documented UFR from 02:56 p.m. -03:01 p.m. was 1020 mL/kg/hr; the UFR from 03:31 p.m. -04:01 p.m. was 970 mL/kg/hr. 2. During an interview on 10/18/2024 at 11:30 a.m., Staff #1 stated that verbal orders from Staff #2 were given to Staff #1 to modify Patient A’s treatment orders. Review of Patient A’s medical records revealed that there were no documented modified orders from Patient A’s nephrologist that modified Patient A’s treatment orders. 3. During an interview on 10/18/2024 at 12:13 p.m., Staff #2 confirmed awareness of the patient’s UFR trend and expressed no safety concerns to the surveyor. Staff #2 stated that documentation of provider to nurse communication will need to improve moving forward. 4. On 10/18/2024 at 02:00 p.m., the surveyor reviewed the “Fluid and Blood Pressure Management Report” of all patients from 10/01/2024 -10/17/2024 and observed that aside from Patient A, Patient B also had documented UFR’s that exceeded the maximum order prescribed. a. On treatment 10/01/2024 through 10/17/2024, based on record review of Patient B’s treatment flowsheet, Patient B’s ordered target weight was 54.5 kg and the ordered maximum UFR was 13 mL/kg/hr. Based on this information, the calculated UFR was 708.5 mL/kg/hr. b. Review of Patient B’s treatment flowsheet from 10/01/2024 through 10/17/2024 revealed noncompliance with the prescribed maximum UFR. The review demonstrated that 7 out of 8 (88%) treatment dates audited exceeded the maximum UFR prescribed. See documented examples below: i. On 10/17/2024, the documented UFR from 07:31 a.m. -10:31 a.m. was 820 mL/kg/hr. ii. On 10/08/2024, the documented UFR from 08:01 a.m. -11:31 a.m. was 820 mL/kg/hr. 5. During an interview on 10/18/2024 at 02:30 p.m., Manager of Clinical Services stated that the facility’s policies and procedures stated above were not followed by the staff members involved and an immediate education will be completed for all direct patient care staff.”

“PA-RD-NUTRITIONAL STATUS CFR(s): 494.80(a)(6) The patient’s comprehensive assessment must include, but is not limited to, the following: (6) Evaluation of nutritional status by a dietitian This Standard is not met as evidenced by: 47759 Based on observations, record reviews and a staff interview, the facility’s governing body failed to ensure that that all patients’ nutritional assessments and nutritional plan of care were individualized to address the patients’ needs. This failure placed Patient C at potential risk of harm and denied their rights to a minimum standard of medical care. Findings Included: On 10/17/2024 from 01:30 p.m.-02:00 p.m., review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 1-14-01) determined that page 1 number 2 stated, “The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs.” Number 2 stated, “ Assessment criteria will include, but not be limited to, evaluation of: Nutritional status by dietitian” On 10/16/2024 from 12:30 p.m.-01:00 p.m., during review of the facility’s hospitalization log and adverse event log, the surveyor observed that Patient C had a hypoglycemic event in the facility and was hospitalized in July of 2024. On 10/17/2024 from 09:30 a.m. -11:30 a.m., the surveyor requested documentation for the months of July through August regarding evaluation of patient C’s nutritional status regarding glycemic control. The dietician was unable to provide documentation of the assessment of Patient C’s nutritional condition based on metabolic parameters, particularly glycemic control, or of strategies to avoid hospitalization in the future.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 47759 Based on record reviews and a staff interview, 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 10/21/2024 from 11:10 a.m. -11:25 a.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 10/17/2024 from 09:30 a.m. -11:30 a.m., during record review of the selected patients’ Plan of Care (PoC), the surveyor observed that Patient C was readmitted to the facility on 06/24/2024. During review of the patient’s plan of care, the surveyor observed that the patient’s last plan of care was completed 05/27/2023. During an interview on 10/17/2024 at 11:30 a.m., the Facility Administrator stated that the Comprehensive Assessments and Plan of Care for Patient C should have been completed within 30 days per policy.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 47759 Based on observations, a staff interview and record review, the facility’s governing body failed to ensure that adverse events reported were discussed, analyzed, and evaluated for a possible improvement plan by the facility’s Quality Assurance and Performance Improvement (QAPI) Program. This failure placed patients at potential risk of harm by failing to utilize the data gathered to identify potential problems in the facility resulting in delay in interventions aimed at improvement. Findings Included: On 10/21/2024 from 11:10 a.m. -11:25 a.m., review of the facility’s policy titled “Continuous Quality Improvement Program” (Policy 01-14-06) determined that page 2 number 7 stated, “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: Patient Safety including: -Review of sentinel events, review of trends of adverse patient occurrences.” On 10/18/2024 at 03:30 p.m., review of the facility’s Facility Health Records (FHR, also known as the facility’s Quality Assurance and Performance Improvement or QAPI program), the surveyor observed that the facility’s FHR did not have documentation of discussions, analysis, and evaluation for an improvement plan on 4 out of the 7 adverse events that occurred from 01/2024 through 08/2024. Interviews with the Facility Administrator revealed that discussions documented should include a “root cause analysis” and discussions of possible “action plans” to prevent events from recurring.”

“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 10/18/2024 at 10:10 a.m., during record review of the facility’s “Medical Director Agreement” under “Summary of Duties for a Medical Director “ it stated the following: -Participate in development, implementation, review and approval of all Center policies and procedures -Actively oversee, lead and participate in the Center’s monthly Facility Health Meeting (“ FHM “) -Review all patient grievances during FHM -Provide general oversight for safety activities at Center -Work with Center staff to monitor potential safety issues at Center The Medical Director’s signature on the “Medical Director Agreement” and interviews conducted on 10/18/2024 at 10:18 a.m. both confirmed awareness of the duties outlined in the agreement. 1. On 10/18/2024, review of the facility’s “Vaccination and Surveillance Report” revealed failure to ensure that all susceptible patients were offered Hepatitis B Vaccination and were documented. This failure failed to meet the facility’s policy titled “ Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance. “ 2. On 10/17/2024 through 10/18/2024, review of Patient A and Patient B’s treatment flowsheets 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) 3. On 10/17/2024, review of Patient C’s medical records revealed failure to ensure that the nutritional assessment and nutritional plan of care was individualized to address patient specific needs. This finding failed to meet the facility’ s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 1-14-01). 4. On 10/17/2024, review of Patient C’s medical records revealed the facility’s failure to ensure that the initial comprehensive assessments; and plans of care were completed on time. This findings failed to meet the facility’s policy titled “Interdisciplinary team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01). 5. On 10/18/2024, review of the facility’s “Facility Health Meetings” (FHM, also known as QAPI), the surveyor observed the lack of documentation on discussions pertaining to 1. Adverse Events and Patient Plan of Care This finding failed to meet the facility’s policy titled “Continuous Quality Improvement Program” (Policy 1-14-06).”