Sanderling Dialysis of Ramona

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 38542 Based on interview and record review, the facility failed to ensure: 1) consents for dialysis were documented in the patients charts for 4 out of 23 sampled patients (14, 17, 24, 24) and 2) an acknowledgement of receipt of patient rights and an authorization for release of medical records was signed by the patients(25 and 27). As a result, there was a potential treatments were performed without the patients full understanding of the risks and benefits. Findings: 1) Patient 14 was admitted to the facility on 7/1/24 with diagnoses which included Type 2 diabetes mellitus (high blood sugar) per the facility’s facesheet. Patient 17 was admitted to the facility on 12/9/22 with diagnoses which included Type 1 diabetes mellitus (high blood sugar) per the facility’s facesheet. Patient 23 was admitted to the facility on 3/6/24 with diagnoses which included Type 2 diabetes mellitus (high blood sugar) per the facility’s facesheet. Patient 24 was admitted to the facility on 4/21/23 with diagnoses which included Type 2 diabetes mellitus (high blood sugar) per the facility’s facesheet. A review of records was conducted. There were no consents for dialysis documented in the patients’ electronic medical records. 2) Patient 25 was admitted to the facility on 11/10/21 with diagnoses which included impaired renal tubular (tubes in the kidney) function per the facility’s facesheet. A review of records was conducted. There was no acknowledgement of receipt of patient rights documented in Patient’s 25 chart. On 8/29/24 at 4:12 P.M., an interview with the NM was conducted. The NM stated Patient 25 “refused” to sign the acknowledgement of receipt of patient rights but stated he did not document the refusal. Patient 27 was admitted to the facility on 8/23/24 per the facility’s facesheet. A review of records was conducted. A document titled Authorization for Release of Medical Records dated 8/23/23 was signed by a witness but not by the patient. On 8/29/24 at 2:15 P.M., an interview with the NM was conducted. The NM stated Patient 27 “may have missed signing the document.” Per the facility’s policy and procedure titled Patient Rights, Responsibilities and Grievance Procedure dated 11/5/12, “ ...POLICY:..ATTACHMENT A ...Patient Rights and Responsibilities {Facility} require all personnel to strive to ensure that patients are aware of their rights and responsibilities ...PATIENT RIGHTS: INFORMATION ...4. You have the right to be informed of services available in the facility ... TREATMENT AND CARE ...2. You have the right to be informed about all aspects of your care ...” Per the facility’s policy and procedure titled Medical Record Requirements for the PEARL System dated 11/11/12, “ ...Medical Record Requirements for the PEARL System ...5. Obtain signatures (as required) on the following forms and scan into the PEARL system: a. Acknowledgement of Patient Rights b. Consent for dialysis ...j. Release of Medical Information ...””

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 38542 Based on interview and record review, the facility did not follow policy and procedure when treatment was changed to accommodate the training of a non-staff member without disclosure and consents of two out of 23 sampled patients (17 and 22). As a result, there was a potential the patients did not fully understand the treatments conducted and the complications that could have occurred. Findings: Patient 17 was admitted to the facility on 12/9/22 with diagnoses which included Type 1 diabetes mellitus (high blood sugar) per the facility’s facesheet. Patient 22 was admitted to the facility on 8/27/21 with diagnoses which included Type 2 diabetes mellitus (high blood sugar) per the facility’s facesheet. A review of records was conducted. There was no documentation in Patients 17 and 22’s charts of a discussion of this change of treatment modality and whether the patients agreed to the change during the non-staff member’s training. On 8/28/24 at 10 A.M., an interview with the NM was conducted. The NM stated the facility was not certified for a HHD (dialysis performed in a patient’s home) program. The NM stated non-staff members were trained at this facility and used HHD machines to dialyze in-center patients. On 8/28/24 at 1:58 P.M., an interview with Patient 17 was conducted. Patient 17 stated she did not recall if she was asked by the facility if she agreed to dialyze using a different machine. On 8/29/24 at 9:45 A.M., an interview with the DOR was conducted. The DOR stated the facility should not have allowed a non-staff member to train on HHD with in-center patients. On 9/4/24 at 9:05 A.M., an interview with Patient 22 was conducted. Patient 22 stated the facility used a “smaller machine” to perform dialysis on her sometime last year. Patient 22 stated the NM informed her they will “try [the HHD machine] on her and eventually they will be used on her at home. Patient 22 stated it was not explained to her why the non-staff member was conducting the treatment with a different machine. Per the facility’s policy and procedure titled Patient Rights, Responsibilities and Grievance Procedure dated 11/5/12, “ ...POLICY:..ATTACHMENT A ...Patient Rights and Responsibilities {Facility} require all personnel to strive to ensure that patients are aware of their rights and responsibilities ...TREATMENT AND CARE ...2. You have the right to be informed about all aspects of your care ...4. You have the right to know of changes to your dialysis prescription and the reasons for those changes.””

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 38542 Based on interview and record review, the facility failed to ensure care plans were: 1) developed for...(14, 16, 17, 23, 2) completed in a timely manner for (15, 21) and 3) discussed between the members of the IDT (21, 23, 24, 25) As a result, issues related to dialysis care were not addressed which could potentially affect overall care and management. Findings: 1) Patient 14 was admitted to the facility on 7/1/24 with diagnoses which included Type 2 diabetes mellitus (high blood sugar) per the facility’s facesheet. Patient 16 was admitted to the facility on 7/19/21 with diagnoses which included Type 2 diabetes mellitus per the facility’s facesheet. Patient 17 was admitted to the facility on 12/9/22 with diagnoses which included Type 1 diabetes mellitus (high blood sugar) per the facility’s facesheet. Patient 23 was admitted on 3/6/24 per the facility’s facesheet. A review of records was conducted. There was no nursing care plan developed for these patients. 2) Patient 15 was admitted to the facility on 5/8/24 with diagnoses which included hypertensive (high BP) chronic kidney disease per the facility’s facesheet. A review of records was conducted. The initial nursing care plan for Patient 15 was created on 6/24/24 and a reassessment care plan was created on 9/2/24. Patient 21 was admitted to the facility on 7/12/21 with diagnoses which included Type 1 diabetes mellitus per the facility’s facesheet. A review of records was conducted. There was no care plan developed for Patient 21 since the last care plan documented on 11/4/22 . On 9/4/24 at 11:31 A.M., an interview with the NM was conducted. The NM stated the first assessment to develop a care plan should be done within the first 30 days of a patient’s admission and reassessed and documented within 90 days of admission. 3) Patient 21 was admitted to the facility on 7/12/21 with diagnoses which included Type 1 diabetes mellitus per the facility’s facesheet. Patient 23 was admitted on 3/6/24 per the facility’s facesheet. Patient 24 was admitted to the facility on 4/21/23 with diagnoses which included Type 2 diabetes mellitus per the facility’s facesheet. Patient 25 was admitted to the facility on 11/10/21 with diagnoses which included impaired renal tubular (tubes in the kidney) function per the facility’s facesheet. A review of records was conducted. There was no documentation of a discussion of the patients’ care plans between the members of the IDT on the patients’ medical records. Per the facility’s policy and procedure titled Performance and Plans of Care, undated, “POLICY:..2. Each patient will receive an evaluation by each member of the IDT in accordance with the following schedule: a. An initial assessment by each member of the Inter-Disciplinary Team (IDT) at the earlier of 30 days from the date of admission or the performance of 13 Hemodialysis Sessions at the Facility. b. A follow-up assessment within 90 days of admission to the Facility (but not less than 60 days of admission) ...d. The 3 parts of the form plus documentation of a discussion that includes the 4 members of the IDT (Nurse, Social Worker, Dietitian and Nephrologist) will be collated and uploaded in the patient’s electronic medical record ...””

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 38542 Based on interview and record review, the facility failed to ensure the staff followed policy and procedure when: 1) there was a decrease in BP during dialysis (procedure to remove waste and excess fluid from the body) for five out of 23 sampled patients (14, 15, 21, 25, 27), 2) a patient’s (20) high BP was not addressed during dialysis, and 3) patient (15) DW 4) In addition, the facility exceeded the maximum allowable fluid removal for As a result, there was a potential for patients to have an increased risk for complications. Findings: 1a.) Patient 14 was admitted to the facility on 7/1/24 with diagnoses which included Type 2 diabetes mellitus (high blood sugar) per the facility’s facesheet. A review of records was conducted. The Hemodialysis Flowsheet dated 8/30/24 indicated Patient 14 had low BP from 7 A.M. to 9:30 A.M. and a post dialysis standing BP of 97/46. There was no documentation the staff re-checked Patient 14’s BP or took the BP more frequently per the facility’s policy. There was no documentation the patient was stable upon discharge when the post dialysis BP was low. 1b.) Patient 15 was admitted to the facility on 5/8/24 with diagnoses which included hypertensive (high BP) chronic kidney disease per the facility’s facesheet. A review of records was conducted. The following Hemodialysis Flowsheets indicated Patient 14 had low BP on : 8/21/24 from 6:11 A.M. to 9:30 A.M.; 8/23/24 from 7:05 A.M. to 9:49 A.M. and 10 A.M. to 11:10 A.M.; 8/26/24 from 6:30 A.M. to 8 A.M. and from 8:30 A.M. to 9:49 A.M. with a post dialysis standing BP of 94/67; 8/28/24 from 6:15 A.M. to 9:54 A.M. and a post dialysis sitting BP of 90/68 and post dialysis standing BP of 89/72; 8/30/24 from 6:30 A.M. to 9:53 A.M. and a post dialysis standing BP of 89/59; and 9/2/24 from 6:23 A.M. to 7 A.M., 8:30 A.M., 9:30 A.M. and 10:05 A.M. There was no documentation the staff re-checked Patient’s BP or took the BP more frequently per the facility’s policy. There was no documentation the patient was stable upon discharge when the post dialysis BP was low. 1c.) Patient 21 was admitted to the facility on 7/12/21 with diagnoses which included Type 1 diabetes mellitus (high blood sugar) per the facility’s facesheet. A review of records was conducted. The Hemodialysis Flowsheet dated 9/2/24 indicated Patient 21 had low BP from 8:02 A.M. to 9 A.M. There was no documentation the staff re-checked Patient’s BP or took the BP more frequently per the facility’s policy. 1d.) Patient 25 was admitted to the facility on 11/10/21 with diagnoses which included impaired renal tubular (tubes in the kidney) function per the facility’s facesheet. A review of records was conducted. The following Hemodialysis Flowsheets indicated Patient 25 had low BP on 8/16/24: from 7 A.M. to 9:01 A.M.; 8/19/24 from 7 A.M. to 9:36 A.M.; 8/21/24 from 7 A.M. to 9 A.M.; 8/23/24 from 8 A.M. to 9:05 A.M. and a post dialysis sitting BP of 71/46 ; 8/26/24 from 8 A.M. to 8:58 A.M.; 8/28/24 from 8:14 A.M. to 9:01 A.M. There was no documentation the staff re-checked Patient’s BP or took the BP more frequently per the facility’s policy. There was no documentation the patient was stable upon discharge when the post dialysis BP was low. On 8/29/24 at 3:33 P.M., an interview with the NM was conducted. The NM stated patients with systolic BP (SBP-pressure in the arteries when the heart contracts) less than 100 (mmHg-millimeters mercury) should not have been discharged. The NM stated the staff should have documented if the patient was asymptomatic and educated patients on the low BP at discharge. On 8/29/24 at 3:40 P.M., an interview with the DOR was conducted. The DOR stated Patient 25 should not have been discharged with a post-dialysis BP of 71/36 on 8/23/24. 1e.) Patient 27 was admitted to the facility on 8/23/24 per the facility’s facesheet. A review of records was conducted. The Hemodialysis Flowsheet dated 8/26/24 indicated Patient had a post dialysis BP sitting BP of 97/78. There was no documentation the BP was rechecked or the patient was stable upon discharge when the post dialysis BP was low. On 8/29/24 at 3:33 P.M., an interview with the NM was conducted. The NM stated when patients have low BP, the staff had to assess the situation, readjust the BP cuff and recheck the BP. The NM stated if the BP was still low, the patients can be repositioned or given fluids. The NM stated the BP should have been checked more frequently than every 30 minutes. On 9/4/24 at 3:41 P.M., an interview with PCT 2 was conducted. PCT 2 stated when patients experience hypotension (low BP) during dialysis, the BP should have been taken every 15 minutes. Per the facility’s policy and procedure titled Monitoring During Treatment dated 11/3/12, “PROCEDURE: 1. PATIENTS CHECKS: a. Check blood pressure every 30 minutes or more frequently depending on patient’s needs. Report to the nurse in charge B/P ...<80 systolic or any significant change or trends. KEY POINTS: 1. To ensure the blood pressure remains stable and to treat unstable blood pressure.” 2) Patient 20 was admitted to the facility on 10/30/23 with diagnoses which included Type 2 diabetes mellitus (high blood sugar) per the facility’s facesheet. A review of records was conducted. The Hemodialysis Flowsheet dated: 8/21/24 indicated Patient 20 had a high pre-dialysis BP of 225/85 and high SBP from 10:30 A.M. to 12 P.M.; 8/28/24 high BP pre-dialysis of 206/83 and high SBP from 10:34 A.M. to 11 A.M. There was no documentation the high BP was addressed or that the staff re-checked Patient’s BP or took the BP more frequently per the facility’s policy. On 9/5/24 at 9:45 A.M., an interview with the NM was conducted. The NM stated when the SBP was >200 and it was not decreasing after an hour, the patient should have been given a BP-lowering medication. The NM stated the high BP should have been addressed. The NM stated the expectation was for the PCT to inform the nurse of the patient’s high BP. Per the facility’s policy and procedure titled Monitoring During Treatment dated 11/3/12, “PROCEDURE: 1. PATIENTS CHECKS: a. Check blood pressure every 30 minutes or more frequently depending on patient’s needs. Report to the nurse in charge B/P greater than 200 mmHg systolic ...or any significant change or trends. KEY POINTS: 1. To ensure the blood pressure remains stable and to treat unstable blood pressure.” Per the facility’s policy and procedure titled Hypertension dated 8/1/12, “ ...POLICY:..4. If the pre-dialysis systolic blood pressure is greater than 200 mmHg, notify the physician ...” 3) Patient 15 was admitted to the facility on 5/8/24 with diagnoses which included hypertensive (high BP) chronic kidney disease per the facility’s facesheet. A review of records was conducted. The Hemodialysis Flowsheets indicated Patient 15 had been under his DW for the past six treatments: 8/21/24 DW 52 kg Post-dialysis weight 47.3 kg 8/23/24 DW 52 kg Post-dialysis weight 46.2 kg 8/26/24 DW 52 kg Post-dialysis weight 47.1 kg 8/28/24 DW 52 kg Post-dialysis weight 46 8/30/24 DW 52 kg Post-dialysis weight 47.5 kg 9/2/24 DW 52 kg Post-dialysis weight 49.3 kg There was no documentation the physician was informed of the need to adjust Patient 15’s DW.”

“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: 38542 Based on interview and record review, the facility failed to ensure a plan of care was developed for consistently low BP for one out of 23 sampled patients (25). As a result, potential complications may not have been properly addressed or managed. Findings: Patient 25 was admitted to the facility on 11/10/21 with diagnoses which included impaired renal tubular (tubes in the kidney) function per the facility’s facesheet. A review of records was conducted. The Hemodialysis Flowsheet dated: 8/16/24 indicated Patient 25 had low BP from 7 A.M. to 9:01 A.M.; 8/19/24 from 7 A.M. to 9:36 A.M.; 8/21/24 from 7 A.M. to 9 A.M.; 8/23/24 from 8 A.M. to 9:05 A.M. and a post dialysis sitting BP of 71/46 ; 8/26/24 from 8 A.M. to 8:58 A.M.; 8/28/24 from 8:14 A.M. to 9:01 A.M. On 8/29/24 at 3:46 P.M., an interview with the NM was conducted. The NM stated a care plan should have been developed for Patient 25’s low BP. Per the facility’s policy and procedure titled Performance and Plans of Care, undated, “PURPOSE: To ensure that Plans of Care and Patient Assessments are performed in a timely manner ...””

“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: 38542 Based on interview and record review the facility failed to ensure the staff competencies were met. As a result, there was a potential the care provided to a patient may be affected. Findings: On 9/5/24 a review of personnel qualifications records was conducted. PCT 3’s last competency checklist was dated 6/20/22. In addition, there was no documentation PCT 3 was currently competent on chlorine testing (a test to check for water safety). On 9/5/24 at 2:35 P.M., an interview with the DOR was conducted. The DOR stated per the regulations, staff competencies should be conducted annually. The facility did not provide a policy and procedure for personnel qualifications.”