Usrc South Aiken Dialysis

“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: 28883 Based on observation, interview, and review of the policy “Hand Hygiene”, the dialysis facility failed to ensure one of two nurses observed discontinuing a dialysis treatment for a patient with a Central Venous Catheter changed gloves, performed hand hygiene after contaminating the gloves by touching a trash can and prior to handling the central venous catheter. (Registered Nurse #1) The findings include: Observation on 4/29/24 at 1:48 PM revealed Registered Nurse (RN) #1 at machine #16, station #7, discontinuing a dialysis treatment for a patient with a Central Venous Catheter. The nurse opened clean supplies with gloved hands, grabbed a trash can touching the inside surface of the trash bag and pulled it close to the station. RN #1 with the same gloved hands, disconnected the dialysis lines from the catheter ports and failed to discard gloves, perform hand hygiene, and don clean gloves after touching the trash bag and prior to handling the central venous catheter. During an interview on 4/29/24 at 2:00 PM, the surveyor reviewed the observation with RN #1 who verified the findings. Facility policy, entitled “Hand Hygiene” revealed “Hand hygiene should be performed prior to contact with the vascular access site”.”

“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: 28883 Based on observations and interview, the dialysis clinic staff failed to ensure worn/torn/soiled tape had been removed from the dialysis treatment room floor to assure appropriate disinfection of the surface/floor to prevent cross contamination by potential blood borne pathogens or other pathogenic materials. The findings include: Observations on 4/29/24, 4/30/24, and 5/1/24 revealed tape on the floor in front of the clinic’s #18 hemodialysis station shaped in an X pattern. The black tape was worn/torn in places and some had grime and dirt embedded in them turning the color to gray. The floor would not be able to be disinfected appropriately where the tape was as the disinfectant may not get into all the crevices/surfaces of the floor/tape leaving the surface open to contamination by possible blood borne pathogens and potential cross contamination by footwear or anything touching the floor/tape. During an interview on 5/1/24 at 10:05 AM, the Biomedical Technician stated, “The tape on the floor of the patient recliners at each dialysis treatment station had been placed there during the Covid pandemic as a way to ensure distance separation between patients”. During an interview on 5/1/24 at 10:56 AM, the Biomedical Technician stated it was going to be difficult to remove the tape as the floors had been waxed and s/he would have to scrape the tape off. The Biomedical Technician verified the tape covering portions of the floor had grime and dirt stuck on it and was worn/torn in places which would not allow appropriate disinfection of the floors to ensure removal of contamination by potential blood borne pathogens.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 28883 Based on record review, interview, and review of the facility policy, “Patient Hepatitis B Testing/Vaccination/ Seroconversion”, the dialysis clinic staff failed to ensure two of two patients reviewed for Hepatitis B vaccination received appropriate care. Nursing staff failed to obtain signed patient consent prior to vaccination for Hepatitis B and failed to ensure the Engerix-B vaccine had been administered according to manufacturer’s directions for use for Patient #6. Nursing staff failed to ensure action was taken to address Patient #3’s decline in antibodies after initialing responding to the vaccine. The findings include: Record review on 5/1/24 at 2:15 PM revealed Patient #6 was admitted to the facility on 8/11/23 with a diagnosis including End Stage Renal Disease. Review of the chart further revealed the patient signed a Hepatitis B vaccine consent/declination form dated 8/11/23 marking an entry which stated s/he had already received a series and had Hepatitis B antibodies greater than 10 mlU/ml (milli-international units per milliter). Further review of the form noted a handwritten note that indicated on 9/6/23, the patient’s antibody level was less than 4 which indicated the patient was not immune to the Hepatitis B virus and to schedule the patient for the vaccine. Review of the chart revealed no other vaccine form in the record that Patient #6 had signed which indicated the patient consented to receive the Engerix-B vaccination. The Hepatitis B vaccine consent/declination form revealed Engerix- B, dose 2; is given one month after the first dose, dose 3 is given two months after the first dose, and the 4th and final dose is given 6 months after the first dose. Review of the medication administration /treatment sheet documentation for Patient #6 revealed nursing staff administered Engerix- B on 9/15/23 (1st dose), on 10/16/23 (2nd dose), 12/6/23 (3rd dose), on 2/5/24 (4th dose), and a 5th dose on 3/6/24 without a consent for the vaccine and/or administration per recommended by manufacturer guidelines. During an interview on 5/2/24 at 9:50 AM, the Facility Administrator verified the findings. Record review on 5/2/24 at 10:32 AM revealed Patient #3 was admitted to the dialysis clinic on 6/9/22 with a diagnosis including End Stage Renal Disease. Patient #3 signed a consent for the Hepatitis B vaccine and had received the full series of Engerix- B with the last dose given on 2/1/23. Labs dated 3/1/23 revealed a Hepatitis B surface antibody result of 22 mIU/ml which indicated the patient was immune to the Hepatitis B virus. Labs dated 5/3/23 and 10/11/23 revealed the Hepatitis B surface antibody results dropped to 4 mIU/ml or less than 4 mIU/ml (not immune). There was no documentation in the record that the clinic nursing staff addressed the drop in antibody level with the patient no longer immune to the Hepatitis B virus and/or documentation of a 2nd series of vaccines having been administered, a booster dose, and/or communication to the physician related to the findings. During an interview on 5/02/24 at 12:22 PM, the Facility Administrator verified the findings. Facility policy, entitled, “Patient Hepatitis B Testing/ Vaccination/ Seroconversion” revealed “The Initial Vaccine Series, staff test for antibodies 1-2 months after the last dose in the initial vaccine series. If antibodies are less than 10mIU/ml, consider the patient susceptible, revaccinate with an additional series and retest for antibodies. For the 2nd vaccine series: Test for antibodies 1-2 months after the last dose in second vaccine series. If after a second series, patient continues to have antibodies less than 10, consider the patient a non-responder and document the non-responder status in EMR. If antibody result is less than or equal to 10 mIU/ml after the initial or second vaccine series, consider the patient immune and retest annually. Booster Dosing: If antibodies decline to less than 10 mIU/ml after the annual result, administer a booster dose”.”

“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: 28883 Based on observations, interview, and review of the APIC (Association for Professionals in Infection Control and Epidemiology) Position Paper “Safe Injection, Infusion, and medication vial practices in healthcare”, the dialysis clinic nursing staff failed to follow aseptic principles for administering parenteral medication. Three of three nurses observed (Registered Nurses (RN) #1, #2, and #3) failed to disinfect the septum of medication vials before drawing up the 2nd dose of intravenous Heparin. The findings include: Observation on 4/29/24 at 11:11 AM of the treatment room floor revealed Registered Nurse (RN) #1 drawing up Heparin into 2 syringes. RN #1 wiped the septum of the vial and withdrew medication into the 1st syringe then failed to disinfect the septum of the vial with alcohol/other disinfectant before withdrawing heparin into the 2nd syringe. Observation on 4/29/24 at 1:04 PM revealed RN #1 wiped the septum of the vial of heparin and withdrew medication into the 1st syringe then failed to disinfect the septum with alcohol/disinfectant prior to withdrawing heparin into the 2nd syringe. During an interview on 4/29/24 at 1:05 PM, RN #1 stated s/he was not aware of guidelines to disinfect the septum prior to each medication draw. Observation on 4/29/24 at 2:06 PM of the treatment room floor revealed RN #3 drawing up Heparin into 2 syringes. RN #3 wiped the septum of the vial and withdrew medication into the 1st syringe then failed to disinfect the septum of the vial with alcohol/other disinfectant before withdrawing heparin into the 2nd syringe. During an interview on 4/29/24 at 2:25 PM, RN #3 verified the finding. Observation on 4/30/24 at 8:38 AM of the treatment room floor revealed RN #2 drawing up Heparin into 2 syringes. RN #2 wiped the septum of the vial an withdrew medication into the 1st syringe then failed to disinfect the septum of the vial with alcohol/other disinfectant before withdrawing the heparin into the 2nd syringe. During an interview on 4/30/24 at 8:39 AM, RN #2 verified the finding. Review on 5/9/24 of the 2016 APIC Position Paper by S.A. Dolan entitled “Safe Injection, Infusion, and medication vial practices in healthcare” revealed that when drawing up medication “Staff should disinfect the rubber septum on all vials prior to each entry”.”

“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, interview, and review of the APIC (Association for Professionals in Infection Control and Epidemiology) Position Paper “Safe Injection, Infusion, and medication vial practices in healthcare”, the dialysis clinic failed to ensure 1 of 2 nurses observed performing catheter care used acceptable aseptic practices when handling a syringe of normal saline and sterile endcaps used on a patient’s Central Venous Catheter (CVC) site. (Registered Nurse (RN) #3). The findings include: Observation on 4/29/24 at 10:14 AM revealed RN #3 at machine #15, station #18 initiating a dialysis treatment for a patient with a Central Venous Catheter (CVC). The nurse removed the cap on the tip of the normal saline syringe and placed the syringe on a chux. The uncapped tip of the syringe came in contact with the chux and after cleaning the hub of the catheter port with alcohol, RN #3 attached the syringe that was on the chux to the port and flushed it with the saline syringe. Observation on 4/29/24 at 2:10 PM of the treatment floor revealed RN #3 discontinuing a dialysis treatment for a patient at machine #2, station #13. RN #3 opened a pack of sterile endcaps and emptied them onto a chux on the chairside table. Further observation revealed the endcaps with no covers over the ends to prevent the sterile portions of the endcaps from coming into contact with the chux. During an interview on 4/29/24 at 2:25 PM, RN #3 verified the findings of the observations. Review on 5/9/24 of the 2016 APIC Position Paper by S.A. Dolan entitled “Safe Injection, Infusion, and medication vial practices in healthcare” revealed, “To avoid having nonsterile contact with sterile areas of devices, containers, and drugs”.”

“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 observation, interview, and review of the RPC Ultra-Low Total Chlorine Test Procedure, the dialysis facility failed to ensure 1 of 2 Patient Care Technicians (PCT) #1 observed testing dialysis water for total chlorine performed the test correctly by waiting the appropriate amount of time for the test strip to develop. The findings include: Observation on 4/30/24 at 11:29 AM revealed PCT #1 performing a total chlorine test on the dialysis quality water. After swishing the RPC Ultra-Low total chlorine test strip in the water, the technician removed the test strip from the water, flicked the water off the test strip, waited 43 seconds, and compared the test strip to the color chart. During an interview on 4/30/24 at 11:35 AM, PCT #1 stated s/he had waited 30 seconds before reading the test strip results. Review on 5/2/24 at 12:00 PM of the RPC Ultra-Low Total Chlorine Test Procedure revealed that “After dipping the test strip in the water sample, to remove the strip and shake once to remove excess water, and wait 20 seconds for the test strip color to develop. After the 20 second wait period staff are to immediately compare the color strip to the color chart to determine the total chlorine level in the sample”.”

“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 observation, interview, and review of the facility policy “Total Chlorine Testing”, the dialysis facility failed to ensure 1 of 2 Patient Care Technicians (PCT #2) observed performing a total chlorine test on dialysis water identified the correct port to check if there was chlorine breakthrough after the primary carbon tank. The findings include: Observation on 4/29/24 at 11:24 AM revealed Patient Care Technician (PCT) #2 performing a water check for total chlorine. PCT #2 obtained the water sample correctly from the port between the primary and secondary carbon tanks. During an interview on 4/29/24 at 11:28 AM, the technician was asked which water port s/he would check if the result of the test had been greater than the allowable limit. PCT #2 stated s/he would redo the test at the same port, and if that was greater than the allowable limit; s/he would go downstream from the carbon tanks to do the check and pointed to the sample port before the primary carbon tank instead of the port after the secondary carbon tank. When the surveyor repeated the same question again, PCT #2 again pointed to the port in front of the primary carbon tank and stated it was the post secondary port. Facility policy, entitled “Total Chlorine Testing” revealed that, “Once results of repeat total chlorine testing from the primary carbon filter indicate a level greater than or equal to 0.1 ppm (parts per million)... staff are to proceed immediately and draw a water sample for Total Chlorine testing from the sample port located downstream of the second carbon tank or set of tanks...”.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 28883 Based on observation, interview, review of the facility “Occurrence/Incident Reports Including Close Call/Near Miss” report, the facility Quality and Performance Improvement Meeting minutes and the facility policy and procedure “Blood Leak Detection”, the dialysis clinic staff failed to ensure a possible blood leak/dialyzer event was reported, reviewed, tracked, and/or any performance improvements initiated to prevent another occurrence and/or potential cross contamination to another patient. The findings include: Observation on 4/29/24 at 11:56 AM revealed a used dialyzer with blood residue in a red biohazard bag in the lab refrigerator. There was no name or date on the bag to indicate a patient and/or date/time the dialyzer had been used or what had occurred. During an interview on 4/29/24 at 11:58 AM, the Facility Administrator (FA) was unsure and thought it may have been placed in the refrigerator due to a blood leak. During an interview on 4/29/24 at 12:05 PM, the FA stated, “The dialyzer had been saved because of a blood leak”. The FA was unsure how long they needed to keep the dialyzer after the blood leak, how long ago the blood leak had occurred, or which patient the dialyzer had been used for. Review on 4/30/24 at 8:48 AM of the “Incident/Occurrence Report” revealed no documentation related to a dialyzer blood leak or other incident which would explain why a dialyzer had been stored in the lab refrigerator. Facility policy, entitled “Blood Leak Detection” revealed following a blood leak, “The dialyzer should be retained in the lab refrigerator or designated dirty area for possible return to the manufacturer...an Occurrence/Incident report should be completed...for tracking and quality improvement purposes blood leaks should be classified under Supply: Medical Product Defect: Dialyzer/Blood Leak..the machine involved in a blood leak should be bleached and rinsed prior to the next patient use and the machine disinfection log should be completed”. Facility policy, entitled “Occurrence/Incident Reports (O/IR) Including Close Call/Near Miss” revealed “...Technical occurrence/incidents: ...All technical incidents that involve the patient or result in treatment interruption, medical injuries or errors will be documented on an O/IR and technical services will be notified...”. During an interview on 4/30/24 at 11:38 AM, the Biomedical Technician stated that staff may have called and notified her/him of a dialyzer blood leak and asked what to do related to bleaching the hemodialysis machine because of a blood leak. S/he did not have any documentation of a call and stated s/he may be confusing calls from another clinic. When asked when this may have happened, the Biomedical Technician stated it had to have been in the past 2 months. The Biomedical Technician stated there had been no Incident/Occurrence report filled out and that s/he wouldn’t have been the person responsible to do an Incident report. Review on 5/2/24 at 9:00 AM of the disinfection logs for the past 2 months of all the clinic’s hemodialysis machines revealed no documentation of a machine being bleached in response to a blood leak other than the documentation of the routine weekly bleach disinfection of all the hemodialysis machines. During an interview on 5/2/24 at 9:07 AM, the Biomedical Technician stated s/he had checked and had been unable to find documentation that a machine had been bleached in response to a blood leak. Review on 5/2/24 at 10:30 AM of the facility QAPI (Quality Assessment Performance Improvement meeting minutes for the past 6 months revealed no documentation of a blood leak under the adverse event sections. During an interview on 5/02/24 at 11:00 AM, the Facility Administrator verified the findings.”

“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, interview, and review of the facility policy and procedure “Iron Protocol and Administration”, the dialysis facility failed to ensure 1 of 1 Registered Nurses (RN) #3 observed administering Intravenous Venofer (Iron) administered the medication according to policy and in the timeframe recommended by the manufacturer. The findings include: Observation on 4/30/24 at 11:12 AM of the treatment room floor revealed RN #3 administering/pushing a 50 mg (milligram) dose of Intravenous Venofer (black liquid) into the saline line on the dialysis machine of a patient receiving treatment over 7 seconds with the saline running. After the 7 seconds, RN #3 clamped the saline line with a small amount of light brown substance (Venofer mixed with saline) remaining in the saline line. During an interview on 4/30/24 at 11:12 AM, RN #3 stated s/he was administering Venofer 50 mg (milligrams) through the saline line and had administered half the dose (25 mg) to the patient with the other half left in the saline line. Further observation revealed RN #3 had given the whole syringe of Venofer 50 mg over 7 seconds with very little left in the line. During an observation at 11:16 AM, RN #3 then opened the saline line for 5 seconds which caused the rest of the Venofer (light brown substance in the saline line) to be administered to the patient. RN #3 stated, “Clinic policy allowed for the administration of Venofer this way through the saline line and s/he preferred this way rather than through the venous drip chamber where you pushed a little and had to come back to administer the rest”. Facility policy, entitled “Iron Protocol and Administration” revealed that if administering the medication through the bloodlines to “...Push Venofer slowly over 2 to 5 minutes as recommended by manufacturer....Follow Venofer with 1 ml (milliliter) of air to ensure entire dose is administered...Unclamp the saline line to allow enough normal saline to pass through the line to deliver the entire dose...”.”