Davita Winter Park Hemo 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: 13640 Based on observation, interview and a review of facility documentation, the facility failed to ensure the implementation of a process to confirm that emergency equipment, including normal saline was immediately available. Findings: During an observation of the emergency cart on 4/23/24 at approximately 10:30 AM, a document which listed required contents was reviewed. The document, Emergency Drug Box, indicated that on a weekly basis two bags of “0.9% Normal Saline 250 ML (milliliters)” were present. The form indicated that two bags were present for each week in the month of April. Further observation of the emergency cart revealed that this item was not present. Facility policy Emergency Equipment Checks revealed the following: “The following equipment checks will be performed . . . weekly . . . Emergency cart (crash cart) is clean, operational and supplies/medications have not expired.” The facility was not in compliance with their established process for fully stocking the emergency cart. During an interview of the Administrator on 4/23/24 at approximately 10:40 AM, he confirmed the preceding.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 13640 Based on observation, interview, record review and a review of facility documentation, the facility failed to ensure that a common medication cart was not used to deliver medication to patients. Findings: During floor observations on 4/23/24 at approximately 10:55 AM, a mobile table was observed with 4 syringes on the top surface. The table was positioned near the nurse’s station counter, which was in the center of the treatment floor. At approximately 11:02 AM, the Clinical Coordinator took the mobile table to the vicinity of the chair of patient #9. Once he arrived he administered two medications by IV push: Venofer and Micera. After this, he returned the mobile table to the vicinity of the nurse’s station. Then, at 11:27 AM he took the cart, which had the remaining syringes on it, to the vicinity of the chair of patient #8. Once he arrived he administered the Micera by IV push. At 11:32 AM, he returned the mobile table to the vicinity of the nurse’s station. A review of the Treatment details report for patient #9 revealed that treatment began at 11:01 AM on 4/22/24. It indicated that the following medication were given at 11:03 AM as follows: “Venofer 50 Milligram, intravenous push, one time.” and “”Micera 60 microgram, intravenous; push, ESA.” A review of the Treatment details report for patient #8 revealed that treatment began at 11:23 AM on 4/22/24. It indicated that the following medication was given at 11:30 AM as follows: “Micera 30 microgram, intravenous; push, ESA.” A review of facility policy Infection Control for Dialysis Facilities revealed the following: “If a common supply cart is used to store clean supplies in the patient treatment/training area, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. The cart will not be moved between stations to distribute supplies.” During an interview of the Clinical Coordinator at approximately 11:36 AM on 4/22/24, he confirmed that he should not be transporting medications in the manner as described above. The Clinical Coordinator did not comply with infection control practices and/or follow the facility’s established policy.”

“H20 TEST-DEVIATIONS REQUIRE RESPONSE CFR(s): 494.40(c) Water testing results including, but not limited to, chemical, microbial, and endotoxin levels which meet AAMI action levels or deviate from the AAMI standards must be addressed with a corrective action plan that ensures patient safety. This Standard is not met as evidenced by: 13640 Based on observation and interview the facility failed to ensure chlorine testing was performed in accordance with manufacturer’s directions for use (DFU). Findings: On 4/22/24 at 10:45 AM, patient care technician (PCT A) said he opened this morning and performed the initial chlorine check. He explained he drew 20 ml of test water from post carbon #1 and placed a Hi-Sense total chlorine test strip in the sample water and swizzled for 15 seconds. When asked why he only swizzled the test strip for 15 seconds he replied, there had been a change and that the staff only needed to keep the test strip in the test sample water for 15 seconds. The test strip indicated that the sample water had less than 0.1 ppm of chlorine. PCT A was asked to read the manufacturers DFU that was printed on the back of the chlorine test strip bottle. It noted that the test strip needed a contact time of 30 seconds, not 15 seconds. PCT A performed the chlorine test again but followed the manufactures DFU and the result was less than 0.1 ppm of chlorine. The Biomed was present at the time of the test and stated the contact time for the test strip had always been 30 seconds and the testing procedures had not been changed. On 4/22/24 at 12:20 PM, Patient Care Technician Z, (PCT Z), explained that PCT A was trained to do the chlorine test for 30 seconds.”

“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, record review and a review of facility documentation, the facility failed to ensure that a patient sustained the prescribed dose of dialysis in the form of dialysate flow rate and failed to ensure patients had reached their target weight/estimated dry weight (EDW), during treatment and/or implement a corrective plan when the EDW was not achieved for two of seven sampled patients. (#6, #7) Findings: Record review for patient #6 noted the Treatment Details Report dated 4/15/24 revealed that orders were in place at the time for a Dialysis Flow Rate (DFR) of “600 ML (milliliters)/min (minute.” The document indicated that hemodialysis treatment had begun at 6:13 AM on 4/15/24 and ended at 9:38 AM on 4/15/24. The DFR was set at 500 ML/min at 6:13 AM, 7:13 AM, 7:43 AM, 8:13 AM, 9:12 AM and 9:38 AM. It was set at 510 ML/min at 6:43 AM and 8:42 AM. There was no documentation reflecting that the DFR was administered as ordered (600 ML/min). Continued review of patient #6’s record did not find any notes in the record justifying the use of the non-prescribed rates. A review of facility policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment revealed the following: “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.” The facility was not in compliance with this policy. During an interview with the Administrator on 4/23/24 at approximately 3:00 PM, he confirmed the preceding. On 4/23/24 while completing a record review for patient #7, it was noted that the physician prescribed EDW was 80.5 kilogram (kg). The patient was prescribed three treatments a week and the prescribed treatment time was three hours and thirty minutes. Review of the treatment flow sheets from 4/01/24 to 4/19/24, revealed that patient #7 did not achieve the prescribed EDW on 2 of 9 treatments. On 4/01/24 the patient’s post treatment weight was 83 kg. The nurse noted, in the post treatment assessment, “Pt A&O [alert and orientated] x3. Discharge to home ( routine discharge).” The staff failed to identify that patient #7 had not achieved the prescribed EDW and why the EDW was not attained. Further review noted Patient #7 did not reach their EDW goal on 4/01/24 and 4/17/24, with the patient’s post treatment weight documented as 83.0 kg, and 81.0 kg, respectively. Continued record review for patient #7 revealed there was no evidence, after each treatment, of staff identifying the patient had not achieved their respective EDWs or had implemented a plan, such as scheduling an extra treatment, increasing treatment time or ensuring the dialysis machine’s settings and ultrafiltration rates were correct, to ensure that the prescribed EDW was attained. On 4/22/24 at 3:20 PM, Patient Care Technician, PCT Z, explained how the staff remove excess fluid from the patients during treatment. She said we try to remove excess fluid based on the patient’s physician prescribed dry weight. PCT Z stated that the staff cannot remove more than 13 milliliters per kilogram, of fluid per hour. When asked if the patient weighs more than his dry wight after the dialysis treatment, PCT Z explained if they cannot remove enough fluid to return the patient to their dry weight, she informs the nurse and they would try to remove the excess at the next treatment, or the patient would be offered an extra treatment. On 4/23/24 at 4:10 PM, the Facility Administrator (FA) stated that the staff should not exceed the maximum fluid removal that is noted in the computer for each patient. He stated if a patient does not achieve their estimated dry weight (EDW) during the treatment, extra treatment time may be offered, but the fact that the EDW was not achieved must be addressed. The FA was unable to explain why more fluid was not removed during the dialysis treatment. There was no evidence on the treatment flow sheet that the staff had offered an extra treatment so the patient could achieve the doctor prescribed dry weight.”