Central Florida Kidney Centers Inc.

“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: 39943 Based on observations, interviews, and record reviews the dialysis center failed to ensure all medications and equipment stored in the Emergency Cart and Emergency Evacuation Box were not expired for 1 of 1 crash carts and 1 of 1 Emergency Evacuation Boxes. Findings: On 5/28/24 at 1:15 PM, observations revealed one Emergency [crash] cart and one Emergency Evacuation box to be on the adult hemodialysis treatment floor. The Emergency Cart contained emergency medications for allergic reactions as well as other emergencies. The cart also had emergency equipment on top of it. There was a suction machine, an automated external defibrillator (AED), airways, and an artificial resuscitator (Ambu bag). Emergency oxygen tanks were also noted to the right side of the crash cart. Review of the inventory sheet listed all the medications and equipment stored in the Emergency Cart. The Emergency Cart was opened and all items inside were checked for expiration dates. The following items were found to be expired in the Emergency Cart: 2-60 cc syringes expired 02/28/23 and The following items were expired in the evacuation box: 24-replacement caps expired 03/24 21-nasal cannulas expired 11/13/23 On 5/28/24 at 1:40 PM, the Unit Manager for the hemodialysis unit verified the above items were in the cart and were expired. On 5/28/24 at 1:45 PM, the emergency cart and evacuation box in the pediatric hemodialysis center were checked for expiration dates. The following items were found to be expired in the emergency cart: 20-nasal cannulas expired 03/01/23. On 5/28/24 at 2:00 PM the Director of Clinical Compliance verified the nasal cannulas found in the pediatric emergency cart were expired. She explained she did not know the nasal cannulas had an expiration date. On 05/29/24 at approximately 9:30 AM RN A stated the expired nasal cannulas were for adults. She said, “They would not be used by the children; they would be for the parents.” Review of the policy, “Routine Check of Emergency Supplies, Equipment and Drugs,” issued /revised 07/88. . .09/22 read: Emergency cart and Evacuation Box is to be checked at least once a month for adequate supplies and proper function of equipment. Restocking of supplies will be accomplished as needed after any emergency or as expiration date approaches. . . .”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 13640 Based on observations, interviews and a review of manufacturer documentation, the facility failed to ensure that testing for total chlorine was performed in a proper manner. Findings: During observations of chlorine testing by PCT-A on 05/29/24 at approximately 10:55 AM, he was observed to have failed to properly perform the test when instead of waiting for twenty seconds, as per recommendations by the manufacturer’s instructions, he only waited for 10 seconds to compare the test strip to the color chart to determine the Total Chlorine level in the sample.” A review of the manufacturer’s instructions for the RPC Ultra-Low Total Chlorine Test Strips revealed the following: “Collect a fresh 100 ML (milliliters) sample of water in a clean plastic cup. . . . Remove one test strip from its foil package and swish it in the sample for . . . 60 seconds. . . . Move the strip back and forth at a constant gentle rate . . . Remove the strip and shake once, briskly, to remove excess water. Wait for 20 seconds for the test strip color to develop. . . After the 20 second wait period, immediately compare the strip color to the K100-0118 or K100-0118F color chart to determine the Total Chlorine level in the sample.” During an interview of the BioMed Manager on 05/29/24 at approximately 11:00 AM, he confirmed that the test had not been performed properly.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 13640 Based on observations, interviews and a review of facility documentation, the facility failed to ensure that medications were maintained to provide patients with a safe treatment environment. Findings: During observations of the medication cabinet in the Peritoneal Dialysis Training Room on 05/28/24 at approximately 10:28 AM, two 1 Gram vials of Tazicef injections were found with expiration dates of “APR 2024.” During an interview of the Nurse Manager for the Pediatric Department they confirmed that the medication should have been discarded due to the expired dates. A review of facility policy Medication Administration revealed the following: “Nursing staff at each facility is responsible for ensuring that medications are within date (not expired) by the third week of each month. Any medications that are expired or that will expire within the next 30 days should be discarded.””

“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: 39943 Based on observations, interviews, and record review, the dialysis center failed to uncover a patient’s central venous catheter (CVC) access site and line connections during a hemodialysis treatment which increased the risk for undetected accidental needle dislodgement or line disconnection, exsanguination, and potential death for 1 of 5 sampled residents,(#13). Findings: Patient #13 was a three-year-old male who started dialysis treatments on 09/01/20. His diagnoses included end stage renal disease. His treatment orders included in-center hemodialysis three times a week for four hours per treatment via a left internal jugular, tunneled catheter. On 05/29/24 at approximately 11:00 AM, patient #13 was observed lying in a crib in the pediatric dialysis center. RN A wrapped a binder around the patient’s chest and adjusted a strap across his left shoulder attached to the binder. His access site was completely covered. When the RN was asked how she assessed patient #13’s access site she responded that she assessed it at the beginning of his treatment and the end of the treatment. Review of resident #13’s treatment record dated 05/29/24, revealed no documentation of the access site throughout the entire treatment. On 05/30/24 at 9:40 AM the Director of Clinical Compliance confirmed that the access site on a dialysis patient needs to be assessed at least every thirty minutes and it is unacceptable for the site to only be assessed at the beginning and end of a treatment. Review of the policy, “Patient Assessment and Monitoring During Hemodialysis” effective date 1/2021, revised 3/2023 read: Monitoring During Treatment. . . Do not exceed 30 minutes on patient checks to include blood pressure, access checks and patient monitoring and always ensure charted in electronic medical record (EMR).”

“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 interviews and record reviews, the facility failed to ensure that the necessary care and services in the form of a specific prescribed treatment duration and a prescribed blood flow rate to manage the patient’s volume status were followed in one of 11 sampled patients. (#6) Findings: A review of the medical record for patient #6 revealed physician orders of 05/09/24 and also 05/22/24 for a blood flow rate of 350 ML (milliliters)/minute and a treatment duration of three hours and thirty minutes. A review of the HD (hemodialysis) Treatment Flowsheet for 05/22/24 revealed that the patient started hemodialysis treatment at 3:55 PM and it ended just over one hour later at 4:56 PM. Throughout the treatment, a blood flow rate of 200 ML/minute was documented. A nurses note of 05/22/24 at 5:39 PM read: “Tx (treatment) started late due to an approbation from nephrology to use AV (arterio-venous) fistula). Patient did not complete dialysis.” A note of 05/22/24 by the Nurse manager of the Clinical Unit read: “Pt left early due to transportation issues.” There was no entry in documentation for this treatment date which explained why the ordered blood flow rate of 350 ML/minute was not followed nor was there any documentation to indicate that the patient was offered an additional hemodialysis treatment time on another date to make up for the almost two and one half hours that he had missed placing the patient’s volume status at risk. During an interview with the Director of Clinical Operations on 05/30/24 at approximately 10:00 AM she confirmed the preceding.”