Lexington Kidney Center, LLC

“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: 41743 Based on observations, interviews, and review of the facility’s policy, entitled, “Infection Control”, the dialysis staff failed to monitor and implement accepted principles of infection control for hand hygiene for 9 random patients observed exiting the dialysis treatment floor without performing hand hygiene after holding pressure to the dialysis exit sites at termination of the patient’s dialysis treatment. (Random Patient A, B, C, D, E, F, G, H and I) The findings include: Observations on 12/11/2023 between 8:45 AM and 11:00 AM revealed 8 random patients holding cannulation site with gloved hand after dialysis treatment ended and failed to perform hand hygiene after removing the glove and leaving the dialysis treatment floor. Random A at 9:30 AM, Random B at 9:50 AM, Random C at 10:30 AM, Random D at 10:32 AM, Random E at 10:34 AM, Random F at 10:39 AM, Random G at 10:42 AM, and Random H at 10:45 AM. Observations on 12/13/2023 at 11:00 AM revealed Random Patient I failed to perform hand hygiene after removing the glove and leaving the dialysis treatment floor. On 12/13/2023 at 2:45 PM, the Clinical Manager reported “We have had education on this”. Facility policy, entitled, “Infection Control”, revealed, “Patients will be educated and encouraged to wear gloves when holding their access sites after needle removal, wash their hands before entering, and leaving the patient dialsis treatment area.””

“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: 41743 Based on observations, interview, and review of the facility’s policy, entitled, “Infection Control”, 2 of 2 Patient Care Technician (PCT #1 and PCT #5) failed to remove gloves and sanitize hands after touching a contaminated surface or performing patient care. The finding includes: On 12/11/2023 at 9:00 AM, observations of PCT #1 revealed he/she touched chair wheels with gloved hand and failed to remove gloves and perform hand hygiene prior to touching dialysis machine. On 12/13/2023 at 10:33 AM, observations of PCT #5 showed he/she removed gloves but failed to perform hand hygiene prior to donning new gloves. On 12/13/2023 at 2:45 PM, Clinical Manager reported “They’ve been educated on this.” Facility policy, entitled, “Infection Control”, revealed, “Hands are always washed after gloves are removed and between patient contact, as well as after touching blood, body fluids, secretions, excretions and contaminated items”.”

“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: 41743 Based on observations, interviews, and review of facility’s policies, entitled, “MEDICATION POLICY” and “INTRAVENOUS MEDICATION ADMINISTRATION-IV PUSH METHOD”, the dialysis staff failed to follow facility policies and current best practice by leaving medication vials, and unfilled syringes left unattended on the medication counter. One of one Registered Nurse (RN) failed to sanitize medication vial septum prior to needle insertion when withdrawing medications. (RN #3) The findings include: Observations on 12/11/2023 from 10:20 AM to 11:45 AM revealed unattended medication syringes on medication countertop and unlocked refrigerator containing vaccinations. Observations on 12/13/2023 from 10:30 AM to 11:35 AM revealed 6 vials labeled Venofer and unfilled syringes left unattended on the medication counter. Observations on 12/13/2023 at 10:55 AM revealed RN #3 withdrawing medications from vials and failing to sanitize the vial septum with alcohol prior to needle insertion. Facility policy, entitled, “MEDICATION POLICY”, revealed, “Storage of Medications All medications are to be kept in locked cabinets or refrigerators”. Facility policy, entitled, “INTRAVENOUS MEDICATION ADMINISTRATION-IV PUSH METHOD”, revealed, “Swab port of medication vial with alcohol. Maintaining sterility, insert needle, or needleless syringe into vial and extract medication.””

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 41743 Based on observations, interviews, and facility policy, entitled, “ CVC: INITIATION OF TREATMENT”, the dialysis facility failed to ensure its staff followed the dialysis facility’s policies and procedure regarding Central Venous Catheter (CVC) end caps disinfection for 1 of 1 Registered Nurse (RN 1) The finding includes: Observations on 12/11/2023 at 9:10 AM revealed Registered Nurse (RN#1) was observed placing 4x (by) 4 gauze moistened with Alcavis disinfectant around end caps of the patient’s CVC line prior to end of the patient’s dialysis treatment. When RN #1 was asked about this procedure, RN #1 reported “Done 15 minutes before treatment and at end of treatment ...Alcavis disinfects the end caps ...soak the gauze and put around end caps with paper around the gauze ...loosely”. When the facility’s policy was requested as well as the data on Alcavis from the manufacturer, it was noted the facility had no policy regarding soaking end caps before and after use or use of Alcavis. Facility policy, entitled, “ CVC: INITIATION OF TREATMENT”, revealed, “The role of soaking caps in an antiseptic prior to removing them is not clear. It is not a CDC/HICPAC recommendation”.”

“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: 41743 Based on observations, interviews, and review of the manufacturer’s instructions, entitled, “RPC Ultra Low Total Chlorine Test Strips”, the dialysis facility staff failed to follow instructions regarding removing excess water when testing chlorine strips for 2 of 2 Patient Care Technicians (PCT #4 and #1) The findings include: On 12/12/2023 at 11:45 AM, observations of Patient Care Technician #4 performing the Chlorine test revealed PCT #4 removed the sample strip from water sample and shook the test strip 6 times prior to waiting 20 seconds to read the results. The manufacturer’s instruction states to shake once briskly. On 12/13/2023 at 11:45 AM, observations of PCT #1 performing the chlorine test revealed PCT #1 removed the sample strip from the water sample and shook the test strip 3 times prior to waiting 20 seconds to read the results. The manufacturer’s instruction state to shake once briskly. On 12/13/2023 at 2:45 PM, the Clinical Manager verified the findings. Manufacture’s instructions, entitled, “RPC Ultra Low Total Chlorine Test Strips”, revealed, “Remove the strip and shake once, briskly, to remove excess water”.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 41743 Based on observations, interview, and review of manufacturer’s instructions, entitled, “OPERATION OF PORTABLE MYRON L CONDUCTIVITY METER”, 2 of 2 Patient Care Technicians (PCT #1 and #2) observed failed to follow manufacturer’s instructions when performing dialysate conductivity and pH testing when setting up the dialysis machine prior to start of the patient’s dialysis treatment. The dialysis facility failed to follow manufacturer’s instructions regarding calibration of Myron meter D6 at end of day. The finding includes: Observations on 12/11/2023, 12/12/2023, and 12/13/2023 revealed 2 Myron Meters D6 on the dialysis treatment floor and 1 Myron meter D6 in the water treatment room left with PH/ORP sensor wells left uncapped. Observations on 12/11/2023 at 10:25 AM revealed PCT #2 used a syringe lying on the counter beside the Myron Meter D6 to obtain the sample, but failed to rinse the meter prior to testing. PCT #2 performed the test with the machine, and then rinsed the pH/ORP and conductivity wells with tap water, but left pH/ORP sensor uncapped. Observation on 12/11/2023 at 10:35 AM revealed PCT #1 used a syringe lying on the counter beside Myron Meter D6 to obtain the sample, failed to rinse meter prior to testing, performed the test with the machine, and then failed to rinse meter. PCT #1 left pH/ORP sensor uncapped. Observations on 12/13/2023 at 10:45 AM revealed PCT #2 used a syringe lying on the counter beside Myron Meter D6 to obtain the sample, but failed to rinse the meter prior to testing, performed the test with the machine, but then failed to rinse meter and left pH/ORP sensor uncapped. On 12/13/2023 at 2:45 PM with Clinical Manager reports “been talking with staff and biomed”. Record review on 12/11/2023 at 11:25 AM of Myron Meter D6 record for calibrations seen on dialysis treatment floor revealed there was no documentation of end of day calibrations performed by staff. On 112/11/2023 at 12:16 PM, the Clinical Manager and Biomedical staff revealed, “We have not been doing calibrations at the end of the day” and verified the finding. Manufacturer’s instructions, entitled, “OPERATION OF PORTABLE MYRON L CONDUCTIVITY METER”, revealed, “ALWAYS perform a calibration check of the pH sensor at the beginning and end of each workday or more often if required by your clinic’s internal procedures ...The protective cap is removed and the pH/ORP sensor well and conductivity cell are filled and rinsed with the sample enough times to completely replace the storage solution ...After use, the pH/ORP sensor well must be filled with Myron Storage Solution, and the protective cap reinstalled securely ...Both the pH/ORP sensor well and the conductivity cell MUST be rinsed and filled at least 3 times with sample before each measurement is taken ...Fresh dialysis quality water should be used to rinse the plunger and cell cup of the D6 meter ...When you are finished with the D6 meter, RINSE thoroughly with dialysis quality water”.”

“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: 41743 Based on observations, interview, and facility policy, entitled, “Infection Control”, the dialysis staff failed to remove expired supplies from staff access in the laboratory area, medication area, and in the dialysis treatment room. The findings include: Observations on 12/11/2023 from 10:20 AM to 11:45 AM revealed: One 17 gauge needle set expired 05/31/2023 in the dialysis treatment area, 3 cotton tipped applicators expired 11/2020 in the medication area, and 50 white topped lab tubes expired 12/01/2023 in the lab area. Interview with Clinic Manager on 12/11/2023 at 12:16 PM who observed and verified the findings. Facility policy, entitled, “Infection Control”, revealed, “No dialysis supplies or medications may be used after the manufacturer expiration date printed on the package, label, or carton”.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 41743 Based on record reviews, interviews, and review of the facility policy, entitled, “Monitoring & Documentation Of Patient Care During Treatment”, the facility staff failed to monitor Blood Pressure (BP) and patient status every 30 to 45 minutes for 1 of 10 patient charts reviewed. (Patient #2) The finding includes: On 12/13/2023 at 9:40 AM, chart review for Patient #2 revealed documentation during the patient’s dialysis treatment: 12/11/2023 at 10:00 AM: BP 174/98 and at 11:00 AM: BP of 139/84. This is 60 minutes between patient assessments. Dialysis Treatment for Patient #2 on 12/08/2023 revealed: BP 109/62 at 1:00 PM and BP 108/60 at 2:00 PM. This is 60 minutes between patient assessments. Interview on 12/13/2023 at 2:45 PM with the Clinical Manager, he/she verifies the findings. Facility policy, entitled, “Monitoring & Documentation Of Patient Care During Treatment”, revealed, “Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every 30 minutes and PRN (as needed) depending on the patient’s condition includes but is not limited to: Patient blood pressure and heart rate (BP & HR) ...Patient status”.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 41743 Based on observation, interviews, and review of facility policy, entitled, “AVF-AVG Cannulation, Treatment Initiation and Termination”, 3 of 6 Patient Care Technicians (PCT #1, #3 and #6) failed to maintain sterility when cannulating the patient’s vascular access sites. The finding includes: On 12/11/2023 at 10:30 AM, PCT #6 was observed cleaning the random patient’s access site with alcohol, touched the insertion site with a gloved finger, but failed to re-disinfect site after touching. On 12/13/2023 at 10:50 AM, PCT #3 was observed cleaning a random patient’s access site with alcohol, touched insertion site with gloved finger, but failed to re-disinfect site after touching. On 12/13/2023 at 10:55 AM, PCT #1 was observed cleaning a random patient’s access site with alcohol, touched insertion site with gloved finger, but failed to re-disinfect site after touching. On 12/13/2023 at 2:45 PM, the Clinical Manager reported “This is so disappointing.” Facility policy, entitled, “ AVF-AVG Cannulation, Treatment Initiation and Termination”, revealed, “If the access is touched after being disinfected, it must be disinfected again before the needle insertion ...Once the fistula has been prepped, touching it will contaminate the site”.”