Fresenius Kidney Care Florence Medical Mile

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 30011 Based on observations, interview, and review of facility policy and procedure, the dialysis facility failed to ensure expired supplies were removed from the dialysis treatment room and that stained ceiling tiles were replaced in the treatment room. The findings include: Observations on 02/05/24 at 8:25 AM in the dialysis treatment room revealed expired supplies: (50) purple top blood collection tubes expired 01/31/24 and (3) yellow top blood collection tubes expired on 01/31/24. During an interview on 02/05/24 at 8:26 AM, Registered Nurse (RN) 1 verified the findings. Observation on 02/05/24 at 8:30 AM in the dialysis treatment room revealed (5) ceiling tiles above dialysis station 19 with brownish stains. During an interview on 02/05/24 at 3:24 PM, the Biomedical Technician verified the findings. Facility policy, entitled, “Storage of Supplies”, revealed, “Supplies must be rotated First in-first Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date...”.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 30011 Based on observations, interview, and review of facility policy and procedure, the dialysis facility failed to ensure 1 of 3 Registered Nurses (RN 2) performed hand hygiene post glove removal and/or donned clean gloves between dialysis stations. The findings include: Observations on 02/05/24 at 9:25 AM in the dialysis treatment room revealed RN 2 providing central venous catheter (CVC) exit site care wearing clean gloves removed the patient at dialysis station 6 soiled CVC dressing and discarded the dressing. RN 2 discarded the soiled gloves and donned clean gloves without performing hand hygiene. During an interview on 02/07/24 at 1:53 PM, RN 2 stated, “I remove all dressings discard gloves and put on a new one. I do hand hygiene before catheter care and then when I finish.” Observations on 02/05/24 at 9:45 AM in the dialysis treatment room revealed RN 2 wearing clean gloves silenced an alarm at dialysis station 6, and then went to dialysis station 4 wearing the same gloves and silenced the alarm. RN 2 discarded the soiled gloves and performed hand hygiene. During an interview on 02/07/24 at 1:58 PM, RN 2 stated, “Gloves are required when touching the machines.” Facility policy, entitled, “Personal protective Equipment”, revealed, “Change gloves and practice hand hygiene between each patient and/or station to prevent cross contamination...Hand hygiene must always be performed after glove removal...”.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 30011 Based on observations, interview, and review of facility policy and procedure, the dialysis facility failed to ensure two dialysis machines were disinfected according to the facility’s policies and procedures, and the tympanic thermometer was disinfected between patient use. The findings include: Observations on 02/05/24 at 9:20 AM in the dialysis treatment room revealed Certified Clinical Hemodialysis Technician (CCHT) 3 disinfecting the dialysis machine failed to clean the inside window and rotor during disinfection. Observation on 02/05/24 at 10:00 AM in the dialysis treatment room revealed CCHT 1 failed to clean the inside window and rotor during disinfection. During an interview on 02/07/24 at 2:10 PM, CCHT 1 stated, “We are supposed to open the glass, clean it, and clean the wheel.” Observations on 02/05/24 at 10:43 AM in the dialysis treatment area revealed CCHT 1 obtained a tympanic thermometer from a table near the patient scales and obtained the patient’s temperature. After use, CCHT 1 failed to disinfect the thermometer. During an interview on 02/07/24 at 2:10 PM, CCHT 1 stated, “We are supposed to clean them between patients.” Observations on 02/05/24 at 10:15 AM in the dialysis treatment room revealed Registered Nurse (RN) 2 used a clean bleach cloth disinfected the inside and outside of the prime waste receptacle and then the side of the dialysis machine using the same bleach cloth. During an interview on 02/07/24 at 1:52 PM, RN 2 stated, “I usually clean the prime waste bucket first then the rest of the machine”. ` Facility policy, entitled, “Cleaning and Disinfection the Dialysis Station”, revealed, “Procedure: 5.2. Clean around the blood pump rotor with a wetted bleach cloth using 1:10 (one to ten) for visible blood and following with 1:100 (one to one hundred) for surface disinfection...”.”

“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: 30011 Based on observations, interview, and review of facility policy and procedure, the dialysis facility failed to ensure expired medications were removed from the patient treatment area and pre-drawn medications were timed and initialed when drawn. The findings include: Observations on 02/05/24 at 8:10 AM in the dialysis treatment room crash cart revealed the following expired supplies: (2) Adrenalin 1 mg (milligram)/ml (milliliter) single dose vial expired 01/24 and (3) Sodium Bicarbonate injection 50 ml single dose expired 02/01/24. During an interview on 02/05/24 at 8:20 AM, Registered Nurse (RN) 1 verified the findings. Observations on 02/05/24 at 8:50 AM in the dialysis treatment room’s evacuation box revealed the following expired supplies: (20) 1000 ml Normal Saline bags expired 01/24 and (1) 17 fl (fluid) oz (ounce) hand sanitizer gel hand rub expired 01/24. During an interview on 02/05/24 at 8:51 AM, RN 1 verified the findings. Facility policy, entitled, “Medication Preparation and Administration”, revealed, “Monitoring Expired Medications: Expiration dates for all stored medication are to be monitored on a monthly basis. Expired medications are to be discarded via ..... off-site return program or in accordance with local and/or state law...”. Observations on 02/05/24 at 2:15 PM revealed pre-drawn medications that were not labeled with the time and initials when drawn for the following patients: Patient (Pt) 4, Heparin 2400 units intravenous (IVP) push and Venofer 100 mg IVP; Pt 5, Venofer 50 mg intravenous push (IVP) and Heparin 2500 units IVP; Pt 6, Heparin 4000 units IVP; Pt 7, Heparin 3000 units IVP; and Pt 8, Heparin 3000 units IVP. During an interview on 02/05/24 at 2:20 PM, RN 1 stated, “They are supposed to have the date and time on them”. Facility policy, entitled, “Medication Preparation and Administration”, revealed, “All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication...”.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30011 Based on observation, interview, and review of facility policy and procedure, the dialysis facility failed to ensure 1 of 1 Certified Clinical Hemodialysis Technicians (CCHT) 1 responsible for the labeling of Minncare disinfectant used for disinfection of the CWP reverse osmosis system had the training in place to perform the duties accurately. The findings include: Observations on 02/05/24 at 11:48 AM of the Minncare bottle in the CWP machine revealed there were no markings on the Minncare bottle which showed the decrease in the amount of fluid consumed during each disinfection. During an interview on 02/05/24 at 11:45 AM, CCHT 1 stated, “I’ve been doing the water room for three years now. On 02/05/24 at 2:00 PM, CCHT 1 stated, “I haven’t been marking the Minncare jugs. I think the Biomedical Technician (BMT) does that.” On 02/05/24 at 11:49 PM, the Area Technical Operations Manager (ATOM) stated, “Normally CCHT 1 does all of the water room procedures, but it has been marked before. We recommend that it’s marked so we know it’s doing what it’s supposed to. The RO (Reverse Osmosis) machine is disinfected every Tuesday.” On 02/07/24 at 4:19 PM, BMT 1 stated, “I only mark the Minncare bottle when I do the disinfection.” Review of CCHT 1’s personnel training file on 02/05/24 at 3:09 PM revealed CCHT 1 successfully completed annual training on 12/15/23 with validation by BMT 1 to perform the “CWP Chemical Disinfect”. Review of manufacturer guidelines on 02/05/24 at 1:48 PM, revealed, “Step 6: Mark the fluid level and the date on the disinfectant container with a permanent marker...”.”

“MAINTENANCE PER DFU OR 2X/YR;RECORD CFR(s): 494.50(b)(1) 7.2.3 Maintenance: per DFU or semiannual/maintenance record Written maintenance procedures and a schedule of preventive maintenance activities designed to minimize equipment malfunctions should be established. In the case of purchased reprocessing equipment or safety equipment, the recommendations of the vendor should be followed unless documented experience supports alternative approaches. If the manufacturer’s recommendations are not available, reuse equipment and safety equipment should be inspected on a semiannual basis. 4 Records 4.3 Equipment maintenance record Records shall be maintained of the dates of preventive maintenance procedures and the results of scheduled testing in order to ensure the proper functioning of reprocessing equipment, environmental-control equipment, safety equipment, or other equipment. 4 Records A place should be provided for the signature or other unique mark of identification of the person ...performing preventative maintenance procedures. This Standard is not met as evidenced by: 30011 Based on observation, interview, and review of facility policy, the dialysis facility failed to ensure fire extinguishers were inspected monthly. The findings include: Observations on 02/05/24 at 8:05 AM in the dialysis treatment room revealed a fire extinguisher with a tag documented with the last inspection on 12/04/23. During an interview on 02/05/24 at 8:51 AM, RN 1 stated, “Technical normally checks our fire extinguisher for us”. During an interview on 0205/24 at 3:39, PM Biomedical Technician (BMT) 1 stated, “I check the fire extinguishers. The last time I checked them was December”. Facility policy, entitled, “Fire Extinguisher, Portable Fire Extinguishers & (and) Means of Egress Program”, revealed, “Fire extinguishers are to be visually inspected monthly...”.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30011 Based on record reviews, interviews, and review of manufacturer guidelines, the dialysis facility failed to ensure daily conductivity and pH monitoring was conducted twice a day on the digital dialysate meter. The findings include: On 02/05/24 at 12:19 PM, review of the facility’s two Myron meter logs revealed documentation for the morning checks for calibration of the Myron meters used to check conductivity and pH values on the days of operation had no documentation of for end of workday checks for the two Myron meters. During an interview on 02/05/24 at 2:00 PM Certified Clinical Hemodialysis Technician (CCHT) 1 stated, “We check the Myron meters first thing in the mornings”. Review of manufacturer guidelines on 02/05/24 at 2:15 PM revealed “Suggested Calibration Intervals: Conductivity: Check against standard conductivity solutions; At the beginning and end of each workday and pH: Check against standard buffer solutions; At the beginning and end of each workday...”.”

“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: 30011 Based on record reviews and interview, the dialysis facility failed to ensure staff signed the patient’s plan of care (POC) on the day of the Interdisciplinary (IDT) meeting for 3 of 4 dialysis patient charts reviewed. (Patient (Pt) 1, 2, and 3) The findings include: On 02/07/24 at 11:07 AM, review of Pt 1’s chart revealed the patient was admitted on 11/09/18 with a diagnosis of End Stage Renal Disease (ESRD), and revealed a stable POC meeting was held on 01/18/23. The Medical Doctor (MD) signed the POC on 01/23/23, Registered Nurse (RN) signed on 01/28/23, Social Worker (SW) signed on 01/18/23, and the Registered Dietician (RD) signed on 01/18/23. During an interview on 02/07/24 at 3:18 PM, the Clinic Manager (CM) verified the findings. On 02/07/24 at 12:20 PM, review of Pt 2’s chart revealed the patient was admitted on 05/18/22 with a diagnosis of ESRD and revealed a stable “annual CIA” meeting was held on 07/18/23. The MD signed the POC on 07/28/23, the RN on 07/18/23, the SW signed on 07/18/23 and the RD signed on 07/18/23. During an interview on 02/07/24 at 3:25 PM, the Clinic Manager (CM) verified the findings. On 02/07/24 at 12:56 PM, review of Pt 3’s chart revealed the patient was admitted on 03/25/19 with a diagnosis of ESRD, and revealed an unstable monthly CIA meeting was held on 10/31/23. The MD did not sign, the RN signed on 10/31/23, the SW signed on 10/31/23, and the RD signed on 10/31/23. A monthly unstable CIA meeting was held on 11/16/23. The MD signed the POC on 11/17/23, RN on 11/16/23, SW signed on 11/16/23, and RD signed on 11/16/23. A monthly unstable CIA meeting was held on 12/14/23. The MD signed on 01/08/24, RN on 12/14/23, SW on 12/14/23 and RD on 12/14/23. During an interview on 02/07/24 at 3:32 PM, the Clinic Manager (CM) verified the findings. Facility policy, entitled, “Comprehensive Interdisciplinary Assessment and Plan of Care”, revealed, “The Plan of Care should be signed at the time of the interdisciplinary team meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDP member within 30 (thirty) days of the interdisciplinary team meeting...”.”