Davita Apopka Dialysis

“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: 52666 Based on observation, interview and policy review the facility failed to ensure that expired medications and supplies were disposed of timely for 1 of 1 observations of the in-center’s hemodialysis emergency evacuation kit. Findings: On 7/30/25 at approximately 3:00 PM, an observation was made of the emergency evacuation kit/tote which revealed the following expired medication and supplies: -5 unopened 30 Milliliter (ML) multi-dose vials of Heparin with an expiration date of 01-APR-2025 (April 1, 2025); -30 sealed packs of 4X4 All Purpose Sponges were noted with an expiration date of 2020-03 (March 2020) (Photographic evidence obtained) On 7/30/25 at approximately 3:20 PM, an interview was conducted with the FA (Facility Administrator). When shown the expiration dates on the vials the FA stated that the medication should have been discarded and not used. When shown the expiration dates on the 4X4 sponges, the FA stated those were the manufactured dates and was unaware that they have expiration dates. She went on to state that the expectation is that expired items are to be discarded and replaced with new items. On 7/30/25 at approximately 3:40 PM, an interview was conducted with the Charge Registered Nurse and the Per-Diem Staff Registered Nurse. They were shown the expiration dates of the 4X4 sponges and the heparin vials. Both nurses agreed that the 4x4’s and heparin vials should have been discarded and replaced since supplies are checked monthly by a staff nurse. A review of the policy/procedure: Facility Emergency Management Plan - Emergency Evacuation Kit (last revised on 10/2024) revealed the following: “8. - Evacuation kit will be sealed with a breakaway lock and is only to be opened in the event of an emergency situation, monthly review, and/or the replacement of an outdated item.” As a result of the proceeding observation, the facility was in violation of their policy.”

“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: 37965 Based on observations, interviews and policy review the End Stage Renal Disease center (ESRD) failed to ensure that multiple use items such as stethoscopes were disinfected before use on patients for 2 of 7 staff members observed (Staff members A and B). stethoscopes. The findings include: On 7/30/25 at approximately 10:53 AM, an observation was made of staff member A, a Patient Care Technician (PCT), during which he was cleaning the dialysis machine at station #1. He was noted to place a stethoscope retrieved from the tray table at station #1 and place it on a pole at station #2. He was not observed to clean the stethoscope. On 7/30/25 at approximately 11:27 AM, Staff member B, Registered Nurse (RN), was observed obtaining a stethoscope from the nursing station and approached station #2 where she was observed to clean the diaphragm of the stethoscope with a small alcohol wipe. She was not observed to clean the entirety of the stethoscope only the diaphragm. After assessing the patient, she returned to the nursing station and placed the stethoscope on the counter. She was not observed to clean the stethoscope prior to placing it on the counter. On 7/30/25 at approximately 11:30 AM, staff member A, PCT was observed to retrieve the stethoscope from behind the dialysis machine at station #2. He used the stethoscope to assess the patient’s dialysis port without cleaning or sanitizing the stethoscope. After assessing the patient’s dialysis port, he hung the stethoscope from the pole attached to the machine. On 7/31/25 at approximately 10:00 AM, an interview was conducted with the Manager of Clinical Services and the Facility Administrator. During the interview they were asked about the cleaning of stethoscopes between patients. The Manager of Clinical Services stated that it is expected that staff are to clean the stethoscope in its entirety between patients. She was asked if cleaning the diaphragm was sufficient she stated “no” and said staff are expected to clean the entire stethoscope. A review of policy 1-05-01 Infection Control for Dialysis Facilities on page 4 of 5 under the heading “Disinfection” item 14. “Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses.” In subsection a. “Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) ...””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 13640 Based on observation, interview and a review of facility documentation, the facility failed to ensure that the access sites of patients were in full view of staff during hemodialysis treatment in one of eight sampled patients (#8). Findings: On 7/30/25 from 9:55 AM and 10:15 AM, patient #8 was observed to have been covered from her chin area to her feet with a blanket which draped over the sides. Since the patient was completely covered, her access site could not be visualized. On 7/30/25 at 10:15 AM, Patient Care Technician (PCT) A confirmed the access site, an Arteriovenous graft (a surgically created connection between an artery and a vein use to provide access for dialysis) on the left thigh, which should not have been covered. He stated that he attempts to check the access when walking past hemodialysis treatment stations and when performing blood pressure assessments. A review of the medical record of patient #8 revealed that the patient had an ordered treatment duration of 240 minutes and that treatment had begun on 7/30/25 at 6:28 AM. A review of facility policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment revealed the following: “The nursing assessment will be performed and documented by a licensed nurse . . . The assessment includes the following components: . . . Verification that the patient access is visible and face is not covered.” Thus, the facility was not in compliance with this policy.”

“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: 37965 Based on observations and review of the facility’s policy and procedure, the facility failed to ensure that heparin was administered per physician order for 2 of 9 residents reviewed (#7 &# 9). Findings: Patient #7 A review of the medical record for patient #7 revealed she was to receive dialysis treatment 3 times weekly for 4 hours each treatment. The patient had a central venous catheter (CVC) through which she was receiving her dialysis treatment. Review of the physician orders dated 7/16/25 revealed she was to receive Heparin 400 units per hour via infusion every dialysis treatment at a rate of 0.4 milliliters per hour. The order noted a stop time for the hourly dose before end of treatment was zero. Review of the treatment details report dated 7/21/25 revealed that patient #7’s dialysis treatment was initiated at 10:24 AM and was terminated at 14:35 PM (2:35 PM). The heparin infusion was noted as infusing at 13:30 (1:30 PM) however at 14:00 (2:00 PM) the heparin was noted to have stopped, indicating the heparin was turned off 35 minutes prior to the end of treatment. Review of the treatment details report dated 7/23/25 revealed that patient #7’s dialysis treatment was initiated at 10:26 AM and was terminated at 14:26 PM (2:46 PM). The heparin infusion was noted as infusing at 13:28 (1:28 PM) however at 13:59 (1:59 PM) the heparin was noted to have stopped, indicating the heparin was turned off 33 minutes prior to the end of treatment. Patient #9 A review of the medical record for patient #9 revealed she was to receive dialysis treatment 3 times weekly for 3 hours each treatment. The patient had a fistula in her right upper arm through which she was receiving her dialysis treatment. Review of the physician orders dated 6/25/25 revealed she was to receive Heparin 400 units per hour via infusion every dialysis treatment at a rate of 0.4 milliliters per hour. The order noted that the infusion stop time was to be 60 minutes before end of treatment. Review of the treatment details report dated 7/02/25 revealed that patient #9’s dialysis treatment was initiated at 11:22 AM and was terminated at 14:15 PM (2:15 PM). The heparin infusion was noted as infusing throughout the treatment. Review of the treatment details report dated 7/21/25 revealed that patient #9’s dialysis treatment was initiated at 11:11 AM and was terminated at 14:12 PM (2:45 PM). The heparin infusion was noted as infusing throughout the treatment. Review of the treatment details report dated 7/23/25 revealed that patient #9’s dialysis treatment was initiated at 11:04 AM and was terminated at 14:18 PM (2:18 PM). The heparin infusion was noted as infusing throughout the treatment. Review of the treatment details report dated 7/30/25 revealed that patient #9’s dialysis treatment was initiated at 11:44 AM and was terminated at 14:45 PM (2:45 PM). The heparin infusion was noted as infusing throughout the treatment. On 7/31/25 at 11:45 AM, an interview was conducted with the Manager of Clinical Services who reviewed the treatment records for patient #7. She verified that the treatments had been stopped several minutes prior to the end of treatment and offered that the patient had recently had the CVC placed and the nurses failed to follow the orders for maintaining the heparin infusion to the end of treatment. She said the patient previously had a fistula (a surgically created connection between an artery and a vein use to provide access for dialysis) which did require that the heparin infusion be stopped 60 minutes prior to the end of treatment. With a CVC the practice is to keep the heparin infusing into the ports throughout treatment to decrease the risk of the CVC ports clotting. She stated that the staff should be following physician orders for heparin infusions. Review of Policy: 1-06-01, “Medication Policy” offers that the purpose of the policy “To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications.” On page 2 of 7, next to item #9, the policy states “Medications are administered as prescribed and then documented in the patient’s 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: 13640 Based on interview and record review, the facility failed to ensure that the plan of care for medication administration was followed for ordered Parsabiv in one of nine sampled patients (#4). Findings: Physician orders dated 7/17/25 read: “Parsabiv 5 milligrams intravenous three times a week.” The Treatment Details Report of 7/22/25 had a nursing entry which read: “Parsabiv . . . Not given. Reason: Missed Administration.” The Treatment Details Report of 7/24/25 had a nursing entry which read: “Parsabiv . . . Not given. Reason: Missed Administration.” There was no further mention in the medical record of the reason why the medication was not given on 7/22/25 and 7/24/25 and there was no evidence of physician notification on either date. A review of facility policy Medication Policy revealed the following: “Medications are administered as prescribed and then documented in the patient’s medical record. . . . Physician will be notified of any medication errors prior to patient leaving the facility. Examples of medication errors include: . . . A prescribed medication not administered to the patient.” Thus, the facility policy was not followed. On 7/31/25 at approximately 11:30 AM, the Manager of Clinical Services stated the medication should have been given on the above dates and the physician should have been notified of the failure to give the medication.”