Fresenius Medical Care Lexington

“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: 28883 Based on observation and interview, Patient Care Technician (PCT) #2, one of two PCTs observed discontinuing a dialysis treatment for a patient with a fistula or graft, failed to instruct or remind a patient to perform hand hygiene after the patient held gauze to their access sites to stop the bleeding. PCT #2 removed the patient’s glove and did not provide hand sanitizer or instruct the patient to wash/sanitize his/her hands. The patient left the treatment room touching the doorknob without performing hand hygiene. The findings included: Observation on 12/17/24 at 12:37 PM revaled a patient at machine 15, station 8, holding pressure with a gloved hand to their dialysis access site to stop the bleeding. Continued observation at 12:41 PM revealed Patient Care Technician (PCT) #2 taping up the patient’s access sites and removing the glove from the patient’s left hand. The patient walked to the scale, got a weight, and walked back to his/her chair letting PCT #2 know what his/her weight was. The patient touched the door knob to open the door and walked out into the lobby without hand hygiene. PCT #2 had not offered the patient hand sanitizer nor reminded/instructed the patient to perform hand hygiene to prevent contamination of the door knob or other objects the patient might touch. During an interview on 12/17/24 at 12:45 PM, PCT #2 was informed about the concern that the patient had not performed hand hygiene after holding pressure to his/her access sites and removing his/her glove. Review on 12/19/24 at 1:50 PM of the policy provided by the dialysis clinic entitled “Hand Hygiene” revealed, “...All staff, patients, patient care givers...must follow the same requirements for hand hygiene...Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water when...Entering and leaving the treatment area, Immediately after removing gloves, After contact with body fluids or excretion...”.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 28883 Based on observations, interviews, and review of the policies “Initiation and Termination of Treatment Using a Central Venous Catheter (CVC)” and “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer”, Registered Nurse #1, one of three nurses observed initiating and discontinuing dialysis treatments for patients with CVCs, failed to ensure patients wore a mask that covered his/her nares and mouth to prevent possible droplet contamination of the ports. The findings included: Observation on 12/17/24 at 9:39 AM revealed Registered Nurse (RN) #1 discontinuing a dialysis treatment for a patient with a Central Venous Catheter (CVC) at machine 16, station 5. The patient had his/her face mask hanging under his/her chin instead of covering the nose and mouth while RN #1 disconnected the dialysis lines from the catheter and flushed one port. The patient then removed his/her mask completely from the chin area and placed it on the chairside table. RN #1 disconnected the 2nd dialysis line from a CVC port and flushed the 2nd port with saline, removed the syringe, scrubbed the two CVC hubs with saline, and injected Heparin into the two CVC ports with the face mask not on the patient. By not ensuring the patient wore a face mask that covered his/her nose and mouth, RN #1 left the CVC ports open to possible contamination with nasal or oral secretions. During an interview on 12/17/24 at 9:52 AM, RN #1 stated s/he hadn’t noticed that the patient wasn’t wearing his/her mask and stated s/he would make sure and look at that the next time. Reviw on 12/19/24 at 1:42 PM of the policy “Initiation and Termination of Treatment Using a Central Venous Catheter (CVC)” revealed that for Infection Control, “...A mask must be worn that covers the nose and mouth by staff, patient and care partner for all procedures that requir accessing the catheter...”. Observation on 12/17/24 at 11:00 AM revealed RN #1 at machine 16, station 5, initiating a dialysis treatment for a patient with a CVC. After performing CVC exit site care, the nurse placed a dressing over the exit site. At this point, the patient’s mask slid down his/her face and was no longer covering his/her nares. RN #1 continued to open the ports, clean the hubs, attach syringes, pull back blood, remove syringes, attach saline syringes, flush the ports; and administer Heparin through a port: all with the face mask not covering the patient’s nares; leaving the ports open to possible droplet contamination. During an interview on 12/17/24 at 11:16 AM, RN #1 looked over at the patient and saw that the patient’s face mask was not covering his/her nares. RN #1 stated s/he hadn’t noticed before. Review on 12/19/24 at 1:40 PM of the policy “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer” revealed that prior to the CVC dressing change and initiation of treatment, nursing staff are to put a mask on the patient.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 28883 Based on a review of acid mixing logs for the past 3 months, interview, and review of the policy “Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit”(DADU)”, the clinic’s Biomedical Technician failed to ensure a separate qualified person documented the review and verification of the specific gravity of the acid batches mixed for October, November, and December 2024. The findings included: Review on 12/17/24 at 2:41 PM of acid mixing logs for October, November, and December 2024 revealed the employee that completed the mixing of the acid concentrate and the reviewer were documented as the same person, the clinic’s Biomedical Technician. The dates the acid batch was mixed with the same person as the reviewer included batches mixed on 12/3/24, 12/8/24, 12/10/24, 12/11/24, 12/16/24, 11/4/24,11/6/24,11/13/24,11/18/24, 11/21/24, 11/22/24, 10/2/24, 10/9/24, 10/15/24, 10/21/24, 10/23/24, and 10/28/24. Entries for “Reviewer’s employee ID number ***Must be different than person who mixed the batch***”, was the same employee ID number. During an interview on 12/18/24 at 2:30 PM the Biomedical Technician verified s/he mixed the batches and documented the review. When asked, the Biomedical Technician stated that the nurses are doing the review. When asked what the review was for, s/he stated they make sure the temperature and specific gravity are correct for the acid solution. Review on 12/18/24 at 3:03 PM of the policy provided by the Area Technical Manager entitled “Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit”(DADU)” revealed “...Final verification of the batch is done through the measurement of the batch temperature (in degrees Celsius) followed by a specific gravity test with a comparison of these results to either GranuFlo Dry Acid Table for Specific Gravities...Specific Gravity testing will be performed according to the Dry Acid Specific Gravity Test Procedure located in the manufacturer’s IFU (Instructions for Use). Specific gravity of the batch must be within or equal to, the high and low range of the expected specific gravity values. Specific gravity from the DADU will be tested: Once the mixing process is completed by the operator and verified by a second staff member. If not immediately transferred a second specific gravity test must be performed immediately prior to transfer by the staff member performing the transfer. Specific gravity from the holding tank will be tested: Following completion of transfer to a holding tank from the DADU. Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation.... The batch record will contain the following information...Operators signature, Verifier’s signature...”.”

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 28883 Based on observations, interviews, and review of the policy “Storage and Handling of Factory Mixed Bicarbonate”, the clinic’s Biomedical Technician failed to ensure commercially prepared bicarbonate had been disposed of after 24 hours per the manufacturer’s instructions. The findings included: Observation on 12/16/24 at 2:56 PM in the Biomedical Technician’s work room revealed 2 opened partially full 1 gallon containers of commercially prepared bicarbonate (Centrisol). There was no date/time on the label to indicate when they had been opened. According to the manufacturer’s instructions on the container, the liquid bicarbonate must be used within 24 hours. According to Registered Nurse #2 who was present at the time, the clinic’s Biomedical Technician had not been in that day. Observation on 12/17/24 at 1:06 PM in the Biomedical Technician’s work room revealed one full opened 1 gallon container of commercially prepared bicarbonate, dated as opened on 12/15/24. When asked, the clinic’s Biomedical Technician was unaware that the manufacturer of the bicarbonate had instructions on the container to “Use within 24 hours”. The Area Technical Manager who was present stated that this bicarbonate was used for maintenance and not for patient dialysis treatment. The Biomedical Technician verified the bicarbonate should have been disposed of after 24 hours after reviewing the instructions on the label. When asked about the 2 commercially prepared concentrate jugs observed on 12/15/24, that did not have a date/time on the container to determine when it was past the beyond use date of 24 hours, the Biomedical Technician verified they had been opened for longer than 24 hours and stated they had been discarded. Review on 12/18/24 at 3:15 PM of the policy provided by the Area Technical Manager entitled “Storage and Handling of Factory Mixed Bicarbonate”, revealed under “Handling” “...Upon opening the container, write the date opened on the container. Any unused bicarbonate concentrate must be discrded at the end of the day when it was opened...”.”

“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: 28883 Based on observations and interview, the dialysis clinic staff failed to ensure the clinic had been equipped to provide a safe and functional environment. Expired supplies had not been removed from staff access in the water treatment room and storage rooms. The findings included: Observation on 12/16/24 at 2:45 PM in the water treatment room revealed a cart with an opened 16 ounce partially filled container of Mesa Labs standard 10.0 pH buffer solution, dated as opened on 9/12/24, with a beyond use date of 12/12/24. The manufacturer’s expiration date on the container was 10/4/24. The bottle of solution, which was in use on the cart with the meter, was past the beyond use date and the expiration date. An unopened container of the 10.0 pH buffer solution on the cart also had a manufacturer’s expiration date of 10/4/24. Further observations on a storage shelf outside the water treatment room revealed 8 unopened 16 ounce containers of 10.0 pH buffer solution that had expired on 10/4/24. Also on a storage shelf were 8 Hemoccult slides that had expired on 10/31/24. The findings were verified by Registered Nurse (RN) #2. When asked if they had any additional containers of 10.0 pH buffer solution that was not expired, s/he stated s/he was unsure but they had gotten in a truck of supplies recently and it may be in boxes waiting to be put up.”

“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: 28883 Based on a review of 6 months of the Continuous Water Purifier (CWP) Reverse Osmosis (RO) disinfection/chemical residual check logs, interviews, and review of the manufacturer’s manual for use, the dialysis clinic staff failed to document weekly chemical disinfections of the RO machine along with the check for residual chemical disinfectant the morning after for disinfections for June, August, September, October, and November 2024. The findings included: Review on 12/17/24 at 1:41 PM of the Continuous Water Purifier (CWP) RO (Reverse Osmosis) disinfection logs and checks for residual disinfectant revealed missing documentation. Documentation that the weekly disinfection had been performed was missing for 8/1/24, 9/19/24, 10/24/24, and 11/21/24. Documentation of residual checks after disinfection were missing for 6/7/24, 6/14/24, 9/27/24, 10/5/24, 11/1/24, and 11/8/24. During an interview on 12/18/24 at 11:30 AM, Patient Care Technician (PCT) #1 stated that both PCTs and at times the Biomedical Technician for the clinic perform the weekly Reverse Osmosis disinfections/ S/he stated the disinfectant residual checks are done the next morning by the opening nursing staff. After a review of the Reverse Osmosis machine disinfection logs and residual checks, PCT #1 verified the missing documentation. During an interview on 12/18/24 at 2:30 PM, the clinic’s Biomedical Technician and Area Technical Manager also verified the findings. Review on 12/18/24 at 3:10 PM of the maintenance manual for the clinic’s Marcor CWP 100, provided by the Area Technical Manager revealed under “Regular Maintenance”, that “...Chemical Disinfection ensures a high microbiological water quality...Disinfection must be performed on a regular basis to ensure consistent microbiological quality of the product water. The required freqency depends on factors such as inlet water quality and operation schedule and should be determined by regular microbiological testing. Disinfection once a week is a minimum...”. Under “Start After Chemical Disinfection” was a warning. “...Do not connect patients until a test for residual disnfectants has been performed...”.”

“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: 28883 Based on record review, interview, and review of the policy “Patient Assessment and Monitoring”, the nursing staff failed to ensure blood pressures and pulse rates had been documented and monitored every 30-45 minutes for Patient #4, one of six patients reviewed for blood pressure/volume management. The findings included: Record review on 12/19/24 at 10:43 AM revealed treatment sheets for Patient #4 that indicated the patient’s blood pressure and pulse rate had not been monitored during treatment timely. On 12/12/24, the blood pressure and pulse had been documented at 1:34 PM, and not again until 2:32 PM. On 12/7/24, the patient’s blood pressure and pulse had been documeted on 12:05 PM, and not again until 1:08 PM. On 12/3/24, the blood pressure and pulse had been documented at 11:01 AM, and not again until 12:08 PM. On 11/27/24, the blood pressure and pulse had been documented at 11:01 AM, and not again until 12:05 PM. During an interview on 12/19/24 at 12:45 PM, the Clinic Manager verified the findings. Review on 12/19/24 at 1:04 PM of the policy provided by the dialysis clinic entitled “Patient Assessment and Monitoring” revealed nursing staff are to obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.”

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 28883 Based on record review and interview, the dialysis clinic nursing staff failed to ensure the medication Sensipar had been administered as ordered for Patient #4, one of two patients reviewed for mineral bone disease managment. The findings included: Record review on 12/19/24 at 10:17 AM revealed Patient #4 had an elevated Parathyroid Hormone (PTH) level of 970 picograms/milliliter (pcg/ml) (high) on 12/12/24, and an elevated PTH of 818 pcg/ml on 11/14/24. Review of physician orders revealed on 10/17/24, the patient had been ordered Sensipar 30 mg (milligrams) orally every treatment for hyperparathyroidism. Review of dialysis treatment sheets revealed the patient did not get a dose of Sensipar on 12/10/24 or 12/17/24. There was no reason documented for not getting the dose on 12/10/24; and on 12/17/24 the nurse documented that the medication was out of stock. During an interview on 12/19/24 at 12:40 PM, the Clinic Manager verified the findings and stated they had ordered the Sensipar dose but it had not come in yet.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 28883 Based on record reviews and interviews, the dialysis clinic nursing staff failed to ensure Venofer (Iron) had been administed for Patient #5 as ordered, or that Mircera, an Erythopoietin Stimulating Agent (ESA) had been held for Patient #7, 2 of 5 patients reviewed for anemia management. The findings included: Review on 12/19/24 at 11:12 AM of the medical record for Patient #5 revealed a Hemoglobin level of 8.1 grams/deciliter (Low) and transferrin saturation level of 14% (Low) on 12/11/24. A Hemoglobin level of 8.2 grams/deciliter (Low) and transferrin saturation level of 14% (Low) had been documented for 12/9/24. A Physician’s order dated 11/22/24 was for Venofer (Iron) 100 mg (milligrams) Intravenous x 10 doses. Review of the patient’s dialysis treatment sheet revealed the patient had not received the dose of Venofer as scheduled on 12/9/24. There was no reason documented as to why the patient did not get the medication. The finding was verified by the Clinic Manager during an interview on 12/19/24 at 12:50 PM. The dialysis clinic admitted Patient #7 on 8/13/24 with diagnoses including End Stage Renal Disease. Record review on 12/19/24 at 12:26 PM revealed physician orders for “Special Attention”, dated 9/17/24 that documented, “Patient has bladder cancer. Oncology to treat anemia”. The order had been entered by the Clinic Manager on 9/17/24 and signed by the Medical Director on 9/18/24. Review of Provider progress notes revealed the patient had received 2 units of packed red blood cells for anemia during his/her hospitalization from 11/11/24 through 11/21/24. Further review of Provider progress notes dated 11/7/24 and 10/19/24 included information that the patient was not to receive ESAs (Erythropoietin Stimulating Agents) due to having cancer, and that they would need clearance from oncology to administer ESAs. Review of dialysis treatment sheets for Patient #7 revealed nursing staff had administered Mircera (ESA) 30 mcg (micrograms) on 10/3/24, Mircera 75 mcg on 10/14/24, and Mircera 50 mcg on 11/25/24. Review of the corresponding physician orders for the Mircera revealed the orders had been put in by a nurse but had not been co-signed by a physician or medical Provider. Further review of the record revealed nothing to indicate there had been a change in directive to not give the patient ESAs. There was nothing documented that they had obtained clearance from oncology to administer the medication Mircera or other ESA medication. During an interview on 12/19/24 at 12:40 PM, the Clinic Manager stated s/he was unaware of clearance from oncology or clearance from the dialysis medical Providers to administer the Mircera.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 28883 Based on observation, record reviews, and interviews, one of two Registered Nurses observed failed to demonstrate the competency necessary to initiate a treatment for a patient with a Central Venous Catheter. Registered Nurse (RN) #3 did not follow procedure and withdraw the heparin lock solution from the catheter limbs/ports before the initiation of the treatment. One of one patients reviewed with an infection, Patient #1, did not receive an intravenous antibiotic as ordered. The findings included: Observation on 12/17/24 at 12:02 PM revealed Registered Nurse (RN) #3 initiating a dialysis treatment for Patient #2, who used a Central Venous Catheter (CVC) for dialysis treatment, at machine 10, station 11. After scrubbing the port hubs with alcohol, the nurse attached saline syringes to each port and flushed them with saline. RN #3 did not attach empty syringes and pull back blood/heparin lock solution from out of the two ports before flushing with saline. The nurse started the patient’s dialysis treatment at 12:28 PM. During an interview on 12/17/24 at 12:33 PM, RN #3 was asked why s/he had not attached empty syringes and drew back blood before flushing the ports with saline. RN #3 along with the surveyor observed the two empty syringes still on the chairside table unused. RN #3 verified s/he had not drawn back blood from the ports before flushing and stated s/he knew better. RN #3 stated that the patient did have a Heparin lock solution (medication to prevent blood clots from forming, which would clot the port) ordered to be administered to both ports after dialysis treatment; and that this Heparin should have been removed by pulling back on the syringes and removing blood from the ports before the saline flush and treatment start. Review on 12/19/24 at 9:44 AM of the treatment sheets for Patient #2 revealed the patient’s last/prior dialysis treatment had been completed on 12/14/24, at which time s/he received a heparin lock solution consisting of Heparin 2100 units instilled in each catheter port post dialysis treatment. This solution had not been removed prior to the dialysis treatment on 12/17/24. Review on 12/19/24 at 1:40 PM of the policy provided by the dialysis clinic entitled “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer” revealed information that 2-10 ml (milliliter) empty syringes were needed to “...7. Remove heparin (or other locking agent) by unclamping the arterial catheter limb and gently aspirating 5 ml fluid from the catheter lumen, then re-clamp. Repeat with venous catheter limb...”. The dialysis clinic admitted Patient #1 on 3/20/23 with diagnoses including End Stage Renal Disease. Record review on 12/18/24 at 12:22 PM revealed Provider notes that documented the patient had been admitted to the hospital from 11/27/24 through 12/7/24 with an ICD (Implantable Cardiac Defibrillator) pocket infection, and was started on intravenous antibiotics. Review of physician orders revealed the patient was to receive Cefipine 2 grams and Vancomycin 500 mg (milligrams) intravenous on 12/11/24. Review of the dialysis treatment sheet dated 12/11/24 revealed Cefipime had been administered, but the nursing staff were unable to administer the Vancomycin as prescribed. There was no reason documented as to why it could not be given. During an interview on 12/19/24 at 12:35 PM, the Clinic Manager reviewed the record and verified the finding.”