Davita Norfolk Dialysis Center

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 45736 Based on observations, facility document review and interview, the facility failed to ensure medication for allergic and anaphylactic reactions was available. The findings included: During the flash tour on 6/24/24, the surveyor conducted a review of the facility’s emergency medications. Upon review, it was determined that there was no medication available to treat an allergic or anaphylactic reaction. The surveyor asked Staff Member #6 about the medication and Staff Member #6 indicated that that was not something they used. In an interview with Staff Member #1 and #2, on June 24, 2024, Staff Member #2 indicated that an Epi-pen (epinephrine injections for allergic and anaphylactic reactions) should be stocked. Staff Member #1 indicated they were not aware this was needed. Staff Member #1 ordered the recommended Epi-pen on June 24, 2024 at 11:52 AM and provided a copy of the order form to the surveyor. A review of a facility policy, “Emergency Equipment Checks”, dated April 2024, revealed, in part, “Purpose: Verify that emergency equipment is maintained in a ready-to-use condition. Policy:...2. Recommended emergency medications to stock in the facility are medications to treat allergic reactions, anaphylactic reactions...””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 45736 Based on observations, facility document review and interview, the facility failed to ensure three (3) multi-dose vials of Heparin were labeled with the date the medication was opened and contain initials of the staff member who opened it. The findings include: During the flash tour on June 24, 2024, the surveyor observed three (3) vials of Heparin 30,000/3mL (milliliter) on the counter. Three of three vials did not contain a date on when they were opened or initials of staff who opened them. In an interview with Staff Member #1 and #2, both staff members indicated that it is the expectations of all staff to label all multi-dose vials with the date it was opened. All staff are expected to include their initials on the multi-dose vial when opened. A review of the facility’s policy, “Medication Policy”, Policy: 1-06-01, dated October 2022, revealed, in part: “...29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle puncture), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and expiration date...””

“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: 45736 Based on medical record review, facility document review and interview, the facility failed to ensure that patients were monitored according to facility policy during and after their dialysis treatment. The findings include: Blood Pressure monitoring: Review of the medical records found no evidence of notification to a licensed nurse or physician about the patient’s abnormal blood pressures during treatment. Two (2) of eleven (11) treatment records included in the survey sample revealed the following documentation gaps: Patient #1 On June 12, 2024 at 7:35 AM the treatment record documented a blood pressure of 196/136 without any interventions taken. On June 14, 2024 at 9:27 AM the treatment record documented a blood pressure of 135/107 without any interventions taken. Patient #10 On June 10, 2024 at 12:28 PM the treatment record documented a blood pressure of 203/98 without any interventions taken. Dialysis Target Weight: Review of the medical records found no evidence that staff notified a licensed nurse or physician about the patient’s post treatment weight being above or below one (1) kg target weight. Three (3) of eleven (11) treatment records included in the survey sample revealed the following information: Patient #3 Patient #3’s dialysis prescription established a target weight of 77.0 kg (kilograms). On May 29, 2024 Patient #3’s pre dialysis weight was documented as 75.9 kg and post dialysis weight as 75.2 kg. The treatment record didn’t contain any documentation that a licensed nurse was notified of the abnormal finding. Patient #6 Patient #6’s dialysis prescription established a target weight of 76.0 kg. On June 10, 2024 Patient #6’s post dialysis weight was documented as 74.1 kg. The treatment record didn’t contain any documentation that a licensed nurse was notified of the abnormal finding. On June 12, 2024 Patient #6’s pre dialysis weight was documented as 74.8 kg and post dialysis weight was documented as 73.8 kg. The treatment record didn’t contain any documentation that a licensed nurse was notified of the abnormal finding. Patient #8 Patient #8’s dialysis prescription established a target weight of 60.0 kg. On June 14, 2024 Patient #8’s pre dialysis weight was documented as 57.3 kg and post dialysis weight as 56.8 kg. The treatment record didn’t contain any documentation that a licensed nurse was notified of the abnormal finding. On June 19, 2024 Patient #8’s pre dialysis weight was documented as 59.0 kg and post dialysis weight as 56.5 kg. The treatment record didn’t contain any documentation that a licensed nurse was notified of the abnormal finding. In an interview with Staff Member #1 and #2 on June 24, 2024, they indicated that if there is an abnormal finding with blood pressure, the staff member is expected to document on the treatment record that a licensed nurse was notified. The licensed nurse would also document any interventions taken on the treatment record. If there is an abnormal finding with a patient’s target weight, this would be documented in the notes section of the treatment record, a licensed nurse would be notified and then the doctor would be notified. A review of a facility policy, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT”, dated April 2024, reveled, in part, “...PRE-TREATMENT DATA COLLECTION/ASSESSMENT. 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during the pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy. If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis...7. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated...INTRADIALYTIC DATA COLLECTION/ASSESSMENT 8. The licensed nurse will round on those patients without reported abnormal finding and complete the nursing assessment within one (1) hour of dialysis treatment initiation. 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring. i. For non-nocturnal treatments is completed at least every thirty (30) minutes. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy)...16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. ABNORMAL FINDINGS...Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Fluid Status: - Pre-treatment - Any weight loss from last post weight - Post-treatment - If patient is above or below 1 kg from the target weight Blood pressure: Pre dialysis: - Systolic greater than 180 mm/Hg or less than 90 mm/Hg - Diastolic greater than or equal to 100 mm/Hg Blood pressure-Intradialytic: - Difference of 20 mm/Hg increase or decrease from patient’s last intradialytic treatment BP reading Blood pressure Post Treatment: - If the patient can stand: - Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg - Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ... - Sitting BP for patient’s that cannot stand: - Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg - Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ...””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 45736 Based on the medical record review, facility document review and staff interview, the facility failed to ensure that the prescribed dialysis blood flow rate (BFR) and/or dialysis flow rate (DFR) was followed for ten (10) of eleven (11) patients included in the survey sample. (Patient #1, 2, 3, 4, 5, 6, 7, 8, 10, 11) The findings include: Patient #1 Six (6) treatment records from June 10, 2024 through June 21, 2024 were reviewed. The prescribed BFR was 400 and DFR was 500. Four (4) of six (6) treatment records revealed BFR and/or DFR outside the prescribed goal. On June 10, 2024 the final average BFR was 318. On June 12, 2024 the final average BFR was 350. On June 19, 2024 the final average BFR was 300 and DFR was 600. On June 21, 2024 the final average BFR was 267. Patient #1 treatment record didn’t document why the BFR and/or DFR were not administered as prescribed. Patient #3 Six (6) treatment records from May 13, 2024 through May 29, 2024 were reviewed. The prescribed BFR was 450. Three (3) of six (6) treatment records revealed BFR outside of the prescribed goal. On May 24, 2024 the final average BFR was 421. On May 27, 2024 the final average BFR was 331. On May 29, 2024 the final average BFR was 394. Patient #3 treatment record didn’t document why the BFR was not administered as prescribed. Patient #4 Six (6) treatment records from June 10, 2024 through June 21, 2024 were reviewed . The prescribed BFR was 600. Four (4) of six (6) treatment records revealed a BFR outside of the prescribed goal. On June 10, 2024 the final average BFR was 487. On June 14, 2024 the final average BFR was 525. On June 19, 2024 the final average BFR was 377. On June 21, 2024 the final average BFR was 518. Patient #4 treatment record didn’t document why the BFR was not administered as prescribed. Patient #5 Six (6) treatment records were reviewed from June 10, 2024 through June 21, 2024. The prescribed BFR was 400 and DFR 500. Two (2) of six (6) treatment records revealed BFR outside of the prescribed goal. On June 19, 2024 the final average BFR was 300. On June 21, 2024 the final average BFR was 372 and DFR was 510. Patient #5 treatment record didn’t document why the BFR was not administered as prescribed. Patient #6 Four (4) treatment records were reviewed from May 27, 2024 through June 18, 2024. The prescribed BFR was 600 and DFR 800. Four (4) of six (6) treatment records revealed BFR and DFR outside of the prescribed goals. On May 27, 2024 the final average BFR was 367 and DFR was 500. On May 31, 2024 the final average BFR was 400 and DFR was 600. On June 14, 2024 the final average BFR was 320 and DFR was 600. On June 18, 2024 the final average BFR was 323. Patient #6 treatment record didn’t document why the BFR was not administered as prescribed. Patient #7 Six (6) treatment records were reviewed from June 10, 2024 through June 21, 2024. The prescribed BFR was 400 and DFR 500. One (1) of six (6) treatment records revealed BFR and DFR outside of the prescribed goals. On June 19,2024 the final average DFR was 763. Patient #7 treatment record didn’t document why the BFR was not administered as prescribed. Patient #8 Six (6) treatment records were reviewed from June 7, 2024 through June 21, 2024. The prescribed BFR was 400 and DFR 500. Four (4) of six (6) treatment records revealed BFR and DFR outside of the prescribed goals. On June 14, 2024 the final average BFR was 310 and DFR was 517. On June 17, 2024 the final average BFR was 292 and DFR was 538. On June 19, 2024 the final average BFR was 353. On June 21, 2024 the final average BFR was 200 and DFR was 800. Patient #8 treatment record didn’t document why the BFR and/or DFR were not administered as prescribed. Patient #10 Six (6) treatment records were reviewed from June 10, 2024 through June 21, 2024. The prescribed BFR was 400 and DFR 500. Three (3) of six (6) treatment records revealed BFR and DFR outside of the prescribed goals. On June 14, 2024 the final average BFR was 325. On June 17, 2024 the final average BFR was 350. On June 21, 2024 the final average BFR was 320 and DFR was 600. Patient #10 treatment record didn’t document why the BFR and/or DFR were not administered as prescribed. In an interview with Staff Member #1 and #2 on June 24, 2024, they indicated that the staff member would document the reason for the alteration in the BFR and/or DFR, in the treatment record, and a licensed nurse would be notified. The licensed nurse would also document in the treatment record, the reason for the alteration in BFR and/or DFR. A review of the facility’s policy, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, dated April 2024, revealed, in part: “... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed...” 19883 Patient #2 The surveyor reviewed six (6) dialysis treatment records from 6/10/24 through 6/21/24. The treatment sheets evidenced an order for a BFR of 400 and a DFR of 500. Three (3) of six (6) treatment records evidenced BFR outside of the prescribed goal. On 6/12/24 the final average BFR was 262. On 6/14/24 the final average BFR was 228. On 6/21/24 the final average BFR was 225. Patient #2’s treatment record didn’t document why the BFR and/or DFR were not administered as prescribed. Patient #11 The surveyor reviewed six (6) dialysis treatment records from 6/10/24 through 6/21/24 for patient #11. The treatment sheets evidenced an order for a BFR of 600 and a DFR of 500. Five (5) of six (6) treatment records evidenced BFR outside of the prescribed goal. On 6/10/24 the final average BFR was 357. On 6/12/24 the final average BFR was 500. On 6/17/24 the final average BFR was 407. On 6/19/24 the final average BFR was 485. On 6/21/24 the final average BFR was 450. Patient #11’s treatment record didn’t document why the BFR and/or DFR were not administered as prescribed.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 45736 Based on medical record review, document review and interview, it was determined that the facility failed to ensure the Plan of Care (POC) was signed by all members of the interdisciplinary team and the patient for one (1) of eleven (11) patients included in the survey sample (Patient #7). The findings include: Medical record review indicated, one (1) of eleven 11) medical records did not contain signatures by all members of the interdisciplinary team and the patient. Patient #7: POC, dated August 28, 2023, failed to include signatures from the doctor, social worker, registered dietician, registered nurse and patient. In an interview with Staff Member #1 and #2 on June 25, 2024, they indicated that the POC should be signed at the meeting with the patient. If the patient does not attend the meeting, it is the expectation that by the following week, the POC will be signed by everyone. A review of the facility’s policy, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, dated July 2023, revealed, in part, “...Plan of Care:...14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or a patient’s personal representative...””

“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: 45736 Based on medical record review, facility document review and interview, it was determined that the facility failed to complete the initial plan of care (POC) within 30 calendar days or 13 treatments for one (1) of eleven (11) patients included in the survey sample (Patient #1). The findings include: Patient #1 was a new admission to this facility on May 3, 2024 and received their first dialysis treatment May 3, 2024. At the time of the survey, Patient #1 did not have a completed POC. Patient #1’s POC was in draft form, had not been reviewed with the patient and did not have signatures from the interdisciplinary team or patient. In an interview on June 25, 2024 Staff Member #1 and #2 indicated that it is the expectation that the POC for new admission would be completed within thirty (30) days or thirteen (13) treatments. A review of a facility policy, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, dated July 2023, revealed, in part, “...4. 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.””