Keowee Dialysis Center LLC

“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 observation and interview, Registered Nurse (RN) #1, one of one nurses observed discontinuing a dialysis treatment for a patient with a Central Venous Catheter (CVC), failed to ensure the patient’s mask covered the nares to prevent potential contamination from nasal droplets. The findings included: Observation on 6/17/24 at 9:52 AM revealed RN #1 at machine 3, station 3, discontinuing a dialysis treatment for a patient with a CVC. The nurse removed the dialysis lines from the CVC ports, attached saline syringes to the ports, and closed the ports with the patient’s mask pulled down below the nares. During an interview with RN #1 on 6/17/24 at 9:56 AM, the patient’s mask was still down. RN #1 was informed of the concern and stated s/he hadn’t noticed the mask has not been covering the nose.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 28883 Based on observation, interview and review of facility policy and procedure, the dialysis facility failed to ensure the testing of the water quality was completed appropriately by knowlegeable staff. The findings include: Cross Reference to V0196: The dialysis clinic failed to ensure Patient Care Technicians (PCTs) #2 and #4 accurately performed the total chlorine test according to manufacturer’s instructions for use and staff was knowledgeable of the maximum allowable limit for total chlorine. (PCT #2) and Registered Nurse (RN) #1. Cross Reference to V0197: The dialysis facilty failed to ensure 2 of 3 Patient Care Technicians was able to identify the correct procedure to be performed for total chlorine breakthrough. (PCTs #2 and #4).”

“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 observation, interview, and review of facility policy, the dialysis staff failed to monitor and implement accepted principles of infection control for hand hygiene for 10 of 10 random patients observed exiting the dialysis treatment area without performing hand hygiene after holding pressure to the dialysis access sites after termination of the patient ‘s dialysis treatment. (Random Patients A, B, C, D, E, F, G, H, I and J). Findings include: Observations on 05/07/2024 from 8:04 AM to 11:15 AM showed Random Patients A, B, C, D, E, F, G, H, I and J holding pressure to their dialysis access sites wearing gloves and without performing hand hygiene. Observations revealed staff did not instruct and encourage the patients to perform hand hygiene. During an interview on 05/08/2024 at 11 AM, the Clinical Manager stated that staff had recent training on patient hand hygiene and verified the findings. Record review of facility policy entitled, “G40 Infection Control” dated 11/29/2022, showed that staff should encourage patients to perform hand hygiene when leaving the treatment area.”

“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: 41743 Based on observations, interviews, and review of facility policy and procedures, the dialysis facility failed to ensure that patient medications were secure and expired medications are discarded timely. Findings include: Observations on 5/07/2024 at 8:04 AM to 11:15 AM of the treatment floor revealed an unlocked medication refrigerator with one vial of PPD (purified protein derivative) tuberculin medication expired on 5/06/2024. On 5/07/2024 at 8:40 AM, Registered Nurse (RN) #1 verified the findings. Observations on 5/07/2024 at 8:04 AM to 11:15 AM of the treatment room floor revealed an unlocked and unattended medication drawers with (6) prefilled syringes labeled Heparin with individual patient identificationn labels. During an interview on 5/08/2024 at 11:00 AM, the Clinical Manager stated that “Medications should be locked”. Facility policy, entitled “G48 Medications: Handling, Administration, Storage & Disposal”, showed that “Medications should never be left unsecured or unattended”. Facility policy, entitled “G40 Infection Control” showed that “Medication vials should be discarded 28 days after opening”.”

“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: 28883 Based on observations, interviews, and review of the RPC Ultra-Low Total Chlorine Test Strips Instructions for Use, the dialysis clinic failed to ensure Patient Care Technicians (PCTs) #2 and #4 accurately performed the total chlorine test according to manufacturer’s instructions for use and staff was knowledgeable of the maximum allowable limit for total chlorine (PCT #2) and Registered Nurse (RN) #1. The findings include: Observation on 5/7/24 at 9:03 AM in the water treatment room revealed Patient Care Technicians (PCTs) #3 and #4 present, with PCT #4 performing a water test for total chlorine. PCT #4 placed the RPC Ultra-low Total Chlorine test strip in the dialysis water and 5 seconds later pressed the timer button and started swishing the test strip. After removing the test strip, PCT #4 compared the test strip to the color chart to read the result immediately. During an interview immediately after the test, PCT #4 verified s/he had placed the test strip in the water prior to setting the timer and swishing the test strip and had removed the test strip from the water and read the test strip immediately without waiting the 20 seconds for the test strip to develop. PCT #3 who was present had not stopped PCT #4 from performing the test incorrectly. Observation on 5/7/24 at 9:13 AM in the water treatment room revealed PCT #2 and Registered Nurse (RN) #1 present, with PCT #2 performing a water test for total chlorine. PCT #2 performed the test using the RPC Ultra-low Total Chlorine test strips. PCT #2 did not rinse the cup used to collect the water (as it had not been known to be free of chlorine) and did not wait 20 seconds to allow the test strip to develop after swishing the test strip in the water before immediately comparing the test strip to the color chart. RN #1 did not intervene while PCT #2 performed the test incorrectly. After the test had been completed, PCT #2 was asked what the maximum allowable limit was. PCT #2 was unsure and pointed to a range on the color chart. When asked which of the colors in the range indicated the maximum allowable limit where staff would need to take action, the technician pointed to 0.05 which was incorrect. RN #1 was asked if PCT #2 had performed the test correctly and s/he stated “yes”. Both PCT #2 and RN #1 were not aware of the manufacturer’s instructions for the RPC Ultra-low Total Chlorine test strips included information to wait 20 seconds after swishing the test strip to allow the color strip to develop. Review on 5/8/24 at 10:27 AM of the “RPC Ultra-Low Total Chlorine Test Strips Instructions for Use” revealed staff are to “Collect a fresh sample of water in a clean plastic sample cup known to be free of chlorine or, prior to collecting the sample, rinse the clean sample cup with the water to be tested. Staff are to remove the test strip from the package and swish it in the water sample for the amount of time indicated according to temperature ranges listed, remove the strip from the water, shake once to remove excess water, and wait 20 seconds for the test strip to develop. After waiting 20 seconds, immediately compare the strip to the color chart to determine the Total Chlorine level in the sample”. Facility policy, entitled “Total Chlorine Testing Policy IC23” revealed information that the ANSI/AAMI (American National Standards Institute/Association for the Advancement of Medical Instrumentation) maximum level of total chlorine would not exceed 0.1 ppm (parts per million). The facility policy acceptable level for Total Chlorine is less than 0.1 ppm.”

“CARBON ADSORP-ACTION IF FIRST TEST + CFR(s): 494.40(a) 5.2.5 Carbon adsorption: action if first test positive When samples from the first sampling port are positive for chlorine or chloramine, operation may be continued for a short time (up to 72 hours) until a replacement bed is installed, provided that samples from the second sampling port remain negative. The replacement bed should be placed in the second position, and the existing second bed should be moved to the first position to replace the exhausted bed. If it is not possible to rotate the position of the beds, both beds should be replaced. This Standard is not met as evidenced by: 28883 Based on observations, interviews, and review of facility policy Chlorine/Chloramine Breakthrough Procedure, the dialysis facilty failed to ensure 2 of 3 Patient Care Technicians was able to identify the correct procedure to be performed for total chlorine breakthrough. (PCTs #2 and #4). The findings include: Observation on 5/7/24 at 9:03 AM revealed Patient Care Technicians (PCTs) #3 and #4 performing a water test for total chlorine. After the test had been completed, PCT #4 was asked what action to take if the total chlorine test after the secondary carbon tank had been greater than the allowable limit. PCT #4 stated s/he would call the appropriate staff to report the abnormal result. PCT #4 did not say anything about discontinuing patient treatments and not reinfusing patients’ blood. Observation on 5/7/24 at 9:13 AM revealed PCT #2 and Registered Nurse (RN) #1 performing a water test for total chlorine. After the test had been completed, PCT #2 was asked what action to take if the test after the secondary carbon tank had been greater than the allowable limit. PCT #2 stated s/he did not know what to do. Facility policy, entitled “Chlorine/Chloramine Breakthrough Procedure IC23B” revealed, “If chlorine breakthrough is confirmed after both the primary and secondary carbon tanks, treatment cannot be resumed. Treatments would need to be discontinued immediately and staff are not to reinfuse blood”.”

“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, interviews, and review of facility policy and procedure, the dialysis clinic staff failed to ensure expired supplies were removed from the patient treatment area and staff access. Findings include: Observations on 05/07/2024 at 8:04 AM to 11:15 AM of the treatment room floor and the lab area revealed the following expired supplies: Glucometer control solution Level 1 expired 4/29/2024, Level 2 expired 4/27/2024. Lab Area: (35) gray top lab tubes expired 5/02/2024 and (73) blue top tubes expired 4/10/2024. During an interview on 5/07/2024 at 9:10 AM, Registered Nurse (RN) #2 verified the findings. Record review of facility policy entitled, “G40 Infection Control” dated 11/29/2022, showed that dialysis supplies may not be used after the manufacturer’s expiration date. 28883 Observation of the dialysis treatment room on 5/7/24 at 8:35 AM revealed an opened container of Cal-rite 50 mS conductivity solution on a counter expired on 4/28/24. During an interview on 5/7/24 at 8:40 AM, Patient Care Technician #2 verified the finding.”

“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 interview and record review of hemodialysis machine disinfection logs, and manufacturer’s manual for Fresenius 2008T Machine Operator’s Manual, the dialysis clinic nursing staff failed to ensure bleach disinfection had been documented for one week for 16 of 19 hemodialysis machines reviewed. (Hemodialysis machines, #1, #2, #4, #5, #6, #7, #8, #9, #10, #11, #12, #15, #16, #17, #18, and #19). The findings include: Review on 5/7/24 at 3:15 PM of the dialysis machine disinfection logs for 3/2024 through 5/7/24 revealed no documented weekly bleach disinfection for machines #1, #2, #3, #4, #5, #6, #7, #8, #9, #20, #11, #12, #15, #16, #17, #18, and #19 on 4/16/24. Further review revealed the last bleach disinfection for the machines was documented on 4/9/24. During an interview on 5/8/24 at 8:20 AM, the Facility Technical Manager verified the findings. Review on 5/8/24 at 10:24 AM of the Fresenius 2008T Machine Operator’s Manual revealed recommendations to have a weekly Chemical/Rinse completed to disinfect the hydraulic system with a corrosive chemical such as bleach.”

“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: 41743 Based on observations, interviews and record reviews, the dialysis clinic failed to ensure education had been provided to patients and staff related to precautions, use, and storage of the Pain Ease skin refrigerant mist spray. There was no clinic policy to address qualifications for staff administering the spray and missing documentation in the medical record of the date/time and name of person administering the refrigerant spray. The findings include: Observation on 05/07/2024 at 10:25 AM of the treatment room floor revealed Certified Clinical Hemodialysis Technician (CCHT) #3 performing cannulation to an AV fistula of Patient #2 using Pain Ease spray prior to venipuncture. Review of the treatment sheet post usage revealed no documentation to report use of this medication. Observation on 05/07/2024 at 10:25 AM showed Patient #1 had a Pain Ease Spray can on the chair side tray. This surveyor questioned Patient #1 if this spray had been used at this treatment and patient replied “yes every treatment”. Review of Patient #1’s treatment sheet post usage revealed no documentation to report use of this medication. 28883 Observation on 5/7/24 at 8:11 AM at station #9, machine #7 revealed Patient Care Technician #3 spraying a mist over Patient #8’s skin before inserting needles into the patient’s dialysis access (graft). Review of the container revealed it was Gebauer’s Pain Ease Mist Aerosol, 3.5 ounce canister with the main ingredient being pentafluoropropane-tetrafluoroethane. The aerosol mist had been dispensed by a pharmacy with the patient’s name on the label. Review of the manufacturer’s product information insert revealed “Federal law restricted the device to sale by or on the order of a licensed healthcare practitioner. Information included that the spray was a vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections and other procedures. There were precautions listed which included not to use on persons with poor circulation or insensitive skin. That when used to produce local freezing of tissues, adjacent skin areas should be protected with petroleum. That freezing may lower resistance to infection and delay healing. Over-application could cause frostbite and/or alter skin pigmentation. To keep out of reach of children, and to not spray longer than 10 seconds”. Review on 5/8/24 at 10:00 AM of physician orders, and treatment sheet/nursing documentation for Patient #8 revealed no documentation related to the use/administration of the Pain Ease skin refrigerant. The Clinic Manager (CM) provided documentation of handwritten physician orders dated 7/26/22 to “Apply EMLA cream/Pain Ease Mist before cannulation on scheduled dialysis days. Use as directed by manufacturer.” During an interview on 5/7/24 at 10:10 AM, the CM verified the 5/7/24 treatment sheet/nursing documentation for Patient #8 did not include that the Pain Ease mist spray had been administered or by whom. During an interview on 5/8/24 at 10:44 AM, the Clinic Manager (CM) stated, “Patients are provided the refrigerant spray by the clinic who orders the product in bulk. The patients use it by physician order and are taking the spray canister home and bringing the spray to the clinic for dialysis nurses/patient care technicians to administer. Patient Care Technicians (PCTs) and nurses, anyone who cannulates patients are able to use the Pain Ease refrigerant mist spray on patients. These nursing staff receive cannulation training on hire and during annual skills checkoffs”. Review on 5/7/24 at 11:16 AM of the PCT/nursing skills checkoffs revealed staff had received cannulation training including the application of medicated numbing creams with no specific documentation to the use of skin refrigerants or the “Pain Ease” mist spray. During an interview on 5/7/24 at 11:20 AM, the CM was unable to provide documentation of training for staff specific on how to administer the spray or precautions related to the use of the skin refrigerant. There was no documented education for patients related to safe storage/use of the spray and/or clinic policy related to the use of the skin refrigerant to include information about qualifications of the staff that would be administering the spray.”