Fmc Yankee Family Dialysis Center

“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: 44223 Based on observation, interview, and facility policy review, the facility failed to ensure that 1 staff member (Registered Nurse [RN] #5) performed adequate infection control practices related to proper glove use during the discontinuation of dialysis treatment for an arteriovenous fistula (AVF) for 1 of 2 patients (#10) observed, out of a total sample of 13 patients. Findings Include: Review of the facility policy, titled Hand Hygiene, published 11/6/23, included the following: Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: - before and after direct contact with patient - entering and leaving the treatment area - before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications - immediately after removing gloves - after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled - after contact with inanimate objects near the patient - when moving from contaminated body to a clean body site of the same patient - after contact with dialysis wall box, concentrate, drain,or water lines - after contact with other objects within the patient station or treatment space During an observation of the treatment area on 5/14/24 at 10:00 A.M., the surveyor observed RN #5 at station #2 preparing Patient #10 for the discontinuation of treatment to his/her AVF. RN #5 applied gloves and proceeded to place a clean drape under the patient’s left arm. RN #5 removed one piece of tape covering the arterial needle. After removing the piece of tape she moved the patient’s portable electronic device with her gloved left hand. She then proceeded to remove the arterial line from the patient’s arm using both of her hands. RN #5 did not remove her gloves, perform hand hygiene, and put on new gloves, before removing the arterial line. After removing the needle, RN #5 reached over to place the needle in the biohazard sharps container attached to the right side of the hemodialysis machine. She lifted up the cover of the sharps container with her gloved right hand and threw the needle away. RN #5 then proceeded with the discontinuation of the venous needle. She did not remove her gloves, perform hand hygiene and put on new gloves prior to discontinuing the venous needle. During an interview on 5/14/24 at 12:15 P.M., RN #5 said she didn’t think she had to change her gloves because she wasn’t accessing the site or doing an invasive procedure. During an interview on 5/14/24 at 2:05 P.M., the Facility Administrator (FA) said RN #5 contaminated her gloves when she touched the portable electronic device and biohazard container and should have changed her gloves and perform hand hygiene before continuing with the discontinuation process.”

“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: 37700 Based on observation, interview, and policy review, the facility failed to ensure 2 of 2 staff members (Registered Nurse [RN] #1 and RN #2) observed, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk for cross contamination of blood borne pathogens. Findings include: Review of the facility policy, entitled, Cleaning and Disinfecting the Dialysis Station, published 9/5/23, included the following: *Use a cloth wetted with 1:100 bleach solution or Environmental Protection Agency (EPA-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, Intravenous (IV) pole, blood pressure (b/p) cuff, hand sanitizer dispenser and holder, chaise wall behind chair). *Clean all surfaces. Make the surfaces glisteningly wet and allow to air dry unless otherwise specified by the manufacturer. 1. The facility failed to ensure that Registered Nurse (RN) #1 adequately cleaned and disinfected contaminated surfaces within station #1. On 5/14/24 at 9:55 A.M., the surveyor observed RN #1 as he cleaned and disinfected station #1 using 1:100 bleach soaked wipes, after the patient previously occupying the station had left. RN #1 failed to clean the outer and inner storage basket located on the right upper side of the dialysis machine, the sanitizer container and holder on the right side of the dialysis machine, the area of the chair under the folding table on the left side of the chair, the needle sharps container located on the lower right side of the machine, the middle to the bottom of the back of the dialysis machine and an oxygen concentrator that had been located in station #1 during treatment. During an interview on 5/14/24 at 10:10 A.M., RN #1 said he did not clean the needle sharps container because it was new. He further said he did not clean the storage basket, the sanitizer container and holder, the area of the chair under the left folding table, the middle to the bottom of the machine and the oxygen concentrator, as required. 44223 2. The facility failed to ensure that Registered Nurse (RN) #2 adequately cleaned and disinfected contaminated surfaces within station #2. On 5/14/24 at 10:25 A.M., the surveyor observed RN #2 disinfect station #2 for the next patient. She was observed disinfecting the hemodialysis machine and hemodialysis chair using 1:100 bleached soaked pads. RN #2 failed to disinfect the needle sharps container on the right side of the machine. She failed to disinfect the two containers of dialysate sitting on the countertop to to the left of the hemodialysis machine. RN #2 also failed to collapse the tray tables on each side of the hemodialysis chair and disinfect in the crevices between the arms of the chair and the tray tables. During an interview on 5/14/24 at 10:45 A.M., RN #2 said she did not wipe down the containers of dialysate but probably should have and she said she also did not drop the tray tables and clean in the crevices but will do that going forward.”

“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: 31240 Based on policy review, record review and interview, the facility failed to ensure timely administration of the hepatitis B vaccine series for one susceptible patient (#2), out of 7 patient records reviewed from a total sample of 13 patients. Findings include: Review of the facility’s policy entitled, Patient Vaccination for Hepatitis B, dated 2/7/22, included the following: *The hepatitis B vaccine shall be offered to all susceptible patients including peritoneal and home hemodialysis patients. *The current vaccine information statement (VIS) will be given to patients prior to administration of each dose of vaccine for hepatitis B. *Protective antibody response is 10 or more milli-international units (mlU) per milliliter (ml). *Protection against hepatitis B is not maintained when antibody titers fall below 10 mlU/ml. *Patients shall sign a vaccination consent/declination form. *Document locally administered vaccines, non-locally administered vaccines and vaccine declinations in the patient’s electronic medical record. Patient #2 was admitted to the facility in February 2024 with a diagnosis of End Stage Renal Disease requiring hemodialysis treatments 3 times a week. Review of the facility’s Hepatitis B Summary Report indicated Patient #2’s most recent hepatitis B status as susceptible and non-vaccinated. The report included the following test results: *Negative hepatitis B surface antigen (HBsAg) test on 4/15/24. *Hepatitis B core antibody test result of <10 on 2/21/24. Review of the medical record included an invoked Health Care Proxy (HCP), dated 9/2/2020, and no evidence of hepatitis B vaccine administrations prior to admission. Further review of the medical record indicated no evidence of a signed hepatitis B vaccine consent or declination form. During an interview on 5/14/24 at 2:10 P.M., the Facility Administrator (FA) said Patient #2 was susceptible to the Hepatitis B virus and had no evidence of previously administered hepatitis B vaccines. She said the facility had contacted the HCP, but the HCP had not signed the vaccine consent form yet indicating whether or not the vaccine would be administered or declined because the HCP was unsure if Patient #2 would continue with dialysis. The FA said that the efforts to contact the HCP had not documented in the medical record, and there was no evidence that Patient #2 had been vaccinated, had been offered or had declined it.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 31240 Based on observation, policy review and interview, 2 of 2 staff members (Registered Nurse [RN] #1 and RN #5) observed, failed to ensure adequate infection control practices related to arteriovenous fistula or graft (AVF/AVG) cannulation for 2 of 2 patients (#8 and #9) observed with an AVF or AVG, out of a total sample of 13 patients. Findings include: Review of the facility’s policy entitled, Access Assessment and Cannulation, dated 5/6/24, included the following: * Prior to treatment, ask patient to wash access area with soap and water, per hand hygiene protocol. If the patient is unable to wash their own access, the staff or care partner should wear gloves to wash the patient’s access with soap and water. * Perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection. NOTE: This method minimizes the risk of contamination the second site while cannulating the first site. 1. For Patient #8, the facility failed to ensure RN #1 adequately washed the AVF access sites with soap and water, in accordance with facility policy. On 5/14/24 at 10:12 A.M., the surveyor observed Patient #8 enter the treatment area, weight him/herself, apply hand gel to his/her hands and then proceed to the dialysis chair. RN #1 was observed as he prepared to cannulate Patient #8’s AVF access sites for dialysis. He disinfected the upper and lower access sites per the policy, and then cannulated each site, however he did not wash the sites before the disinfection process. During an interview on 5/14/24 at 10:50 A.M., Patient #8 said he/she did not wash his/her AVF access sites before RN #1 began the cannulation process. He/She said he/she washes the sites at home. During an interview on 5/14/24 at 10:51 A.M., RN #1 said he did not wash Patient #8’s AVF access sites or ask the patient if he/she had done it when entering the treatment area, but should have. 37700 2. For Patient #9, the facility failed to ensure RN #5 provided adequate infection control measures related to canulation of an AVF. On 5/14/24 at 10:40 A.M., the surveyor observed RN #5 initiate treatment via an AVF for Patient #9. RN #5 palpated the access and chose the upper and lower cannulation sites. She disinfected the upper and lower sites with Povidine Iodine pads and let each site dry. She then palpated the upper access (contaminating the area) with a gloved hand and cannulated the site. She palpated the lower access (contaminating the area) with a gloved hand and cannulated the site. During an interview on 5/14/24 at 11:00 A.M., RN #5 said she had to touch the sites prior to cannulation to ensure accuracy.”

“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: 31240 Based on record review, policy review and interview, the facility failed to 1.) ensure that staff documented theoretical conductivity (TCD) in the medical record for 1 of 5 applicable patients (#2), out of a total sample of 13 patients, and 2.) ensure that 1 of 2 staff members (Registered Nurse [RN] #5) observed followed the manufacturer’s directions for use when checking the pH of the dialysate solution for the hemodialysis machine. Findings include: Review of the facility’s policy entitled, Checking Conductivity and pH of Final Dialysate, dated 5/6/24, included the following: *The TCD is calculated by the machine based on the concentrate formula selected, and the sodium bicarbonate values entered in the dialysate composition screen. *Check TCD on all dialysis machines. To ensure delivery of safe dialysate, the conductivity alarm limits must be maintained at +/- 0.5 mS/cm of the TCD. *Record conductivity and pH readings in the treatment record. 1.) For Patient #2, the facility failed to ensure staff documented the TCD reading in the medical record for 5 of 9 treatments. Patient #2 was admitted to the facility in February 2024 with a diagnosis of End Stage Renal Disease requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 4/24/24 through 5/13/24, indicated that staff failed to document the TCD reading for 5 of 9 treatments, including 4/24/24, 4/26/24, 4/29/24, 5/1/24 and 5/6/24. During an interview on 5/15/24 at 1:25 P.M., the Facility Administrator said the staff had not documented the TCD readings, as required, for the 5 treatment days noted above. 44223 2. The facility failed to ensure that 1 of 2 staff members (RN #5) followed the manufacturer’s directions for use when testing the pH of the dialysate solution for hemodialysis machines. Review of the manufacturer’s directions for use, located on the test strip vial, included the following: * hold one end of strip between index finer and thumb * dip the test strip about 1/2 inch into a cup size sample for 1-2 seconds * remove excess liquid by shaking test strip * immediately match the color of strip to the chart provided with the vial On 5/14/24 at 9:45 A.M., the surveyor observed RN #5 test the pH of the dialysate solution from station #8. While at the dirty sink, she obtained a test strip, submerged the whole strip into the cup of the dialysate solution, removed the strip, and without shaking off the excess liquid, immediately read the strip, comparing it to the color chart provided with the vial. On 5/14/24 at 12:05 P.M., the surveyor observed RN #5 test the pH of the dialysate solution from station #3. While at the dirty sink, she obtained a test strip, submerged the whole strip into the cup of the dialysate solution, removed the strip, and without shaking off the excess liquid, immediately read the strip, comparing it to the color chart provided with the vial. During an interview on 5/14/24 at 12:15 P.M., RN #5 said she should have shaken off the excess fluid from the test strip, but she did not.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 44223 Based on record review and staff interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed relative to the Dialysis Flow Rate (DFR- the measurement of how fast the dialysate solution flows in ml/min) to draw toxins from the patient’s blood during the process of dialysis for 1 of 6 applicable patients (#4), out of a total sample of 13 patients. Findings Include: For Patient #4 the facility failed to ensure the DFR was delivered as prescribed. Patient #4 was admitted to the facility in March 2022 with a diagnosis of End Stage Renal Disease (ESRD) requiring dialysis. Review of the physician orders, dated 4/24/24-5/8/24, indicated the Blood Flow Rate (BFR) was to be delivered at a rate of 450 and the DFR was to be delivered at an autoflow rate of 1.5 (1.5 times the BFR of 450 or 700 ml/min). Review of 9 Hemodialysis Flowsheets dated 4/24/24-5/13/24, indicated the DFR had not been delivered as prescribed for 5 of 9 treatments, including the following: *4/24/24-the DFR was delivered at a rate of 800 ml/min not the autoflow 1.5 rate of 700 ml/min as ordered, with no documentation to indicate why the physician order was not followed. *5/3/24-the DFR was delivered at a rate of 800 ml/min not the autoflow 1.5 rate of 700 ml/min as ordered, with no documentation to indicate why the physician order was not followed. *5/6/24-the DFR was delivered at a rate of 800 ml/min not the autoflow 1.5 rate of 700 ml/min as ordered, with no documentation to indicate why the physician order was not followed. *5/8/24-the DFR was delivered at a rate of 800 ml/min not the autoflow 1.5 rate of 700 ml/min as ordered, with no documentation to indicate why the physician order was not followed. 5/13/24-the DFR was delivered at a rate of 800 ml/min not the autoflow 1.5 rate of 700 ml/min as ordered, with no documentation to indicate why the physician order was not followed. Further review of the treatment flowsheets and the medical record failed to indicate the physician had been notified the DFR had been changed. The physician orders did not indicate an order that the DFR could be changed as needed. During an interview on 5/14/24 at 2:05 P.M., the Facility Administrator (FA) said staff do not usually document in the medical record or on the flowsheets why the flow rate had been run at a different rate. She said that there should be a physician order to change the rate and that the physician should be notified if the flow rate was changed.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 44223 Based on observation, interview, and policy review, the facility failed to ensure 1 of 2 staff (Registered Nurse [RN] #5) observed did not use excessive force to the bag of normal saline for intravenous infusion during the rinse back phase of dialysis (returning of blood back to the patient) for 1 patient (#10) with an arteriovenous fistula or graft (AVF/AVG) observed out of a total sample of 13 patients, increasing the risk of damage to the access site. Findings Include: Review of the facility policy titled, Termination of Treatment Using an Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer, published 2/7/24, indicated the following: *Purpose: The purpose of this policy is to provide direction to reinfuse blood in the extracorporeal system to the patient at completion of the hemodialysis treatment using an arteriovenous fistula (AVF) or Graft and an Optiflux Single Use electron beam (Ebeam) Dialyzer. *While closely monitoring the access site, return blood through the arterial line either by gravity, or by applying gentle pressure to the saline bag. *Do not apply excessive pressure on the saline bag; this may cause damage to the access. On 5/14/24 at 10:00 A.M., the surveyor observed RN #5 at station #2, terminating dialysis for Patient #10. RN #5 twisted the upper portion of the normal saline bag used to flush back the blood and then used excessive force by squeezing the solution back through the dialysis circuit to forcibly push the normal saline back through the dialysis system to the patient’s AVF access. During an interview on 5/14/24 at 12:15 P.M., RN #5 said it is difficult to rinse back Patient #10 so she has to apply some pressure. She also said that her hands are weak so she has to squeeze hard to complete the rinse back. RN #5 said this not normal practice or per policy. During an interview on 5/14/24 at 2:05 P.M., the Facility Administrator (FA) said that staff should not be squeezing or applying excessive pressure to the normal saline bag during rinse back. During the exit conference on 5/15/24 at 2:30 P.M., the FA said Patient #10 has difficulty with his/her access site especially during the rinse back phase. She said that in order for the patient to get as much blood back during the rinse back phase the staff have had to apply more pressure or the blood will back up into the lines and into the normal saline bag. The FA said applying pressure to the normal saline bag during rinse back is not part of their usual practice. She said Patient #10 needs to be seen by vascular and the facility has been trying to set up an appointment but the vascular office is very difficult to work with. The facility did not provide any documentation that the facility has been attempting to schedule a vascular appointment or that the physician is aware that staff need to apply excessive pressure during the rinse back phase.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 38141 Based on review of the facility Quality Assessment Performance Improvement (QAPI) committee meeting minutes, review of the monthly infection control audits and interview, the facility failed to ensure monthly infection control audits were completed for arteriovenous fistula and graft (AVF/AVG) disinfection compliance, to ensure they could be consistently measured, analyzed and a plan developed based on the results of monthly infection control audits. Findings include: Review of the facility policy, titled, Quality Assessment and Performance Improvement Program, dated 5/2/22, indicated the following: *The QAPI Committee will monitor data/information, prioritize areas for improvement, determine potential root cause analysis, develop, implement, evaluate and revise action plans that results in sustainable improvements in patients care. *Elements to be reviewed will include: -patient care outcomes -infection surveillance -staff training and education -patient safety *An effective and successful review of QAPI meeting and program activities will include: -analysis of QAPI tool -review of the results of required self-audits Review of the facility monthly clinical audit checklist for 12 months (May 22, 2023 through April 22, 2024) failed to include audits of care for patients with Arterio-Venous Fistula (AVF) and Arterio-Venous Graft (AVG) access. During the survey, 2 of 2 staff had infection control breaches during initiation of hemodialysis treatment including RN #1 failed to wash a patients access prior to disinfecting and cannulating the AVF and RN #5 failed to disinfect a AVF site after contaminating it during cannulation. During an interview on 5/15/24 at 11:30 A.M., the Facility Administrator (FA) said that there were no infection control audits for AVF and AVG access from May 2023 through present.”

“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: 38141 Based on observation, Quality Assessment and Performance Improvement (QAPI) minutes review, Clinic Audit Checklist review, interview, and policy review, the facility failed to sustain an effective performance improvement program in regard to disinfection of the hemodialysis station. Findings include: Review of the facility policy, titled, Quality Assessment and Performance Improvement Program, dated 5/2/22, indicated the following: *The QAPI Committee will monitor data/information, prioritize areas for improvement, determine potential root cause analysis, develop, implement, evaluate and revise action plans that results in sustainable improvements in patients care. *Elements to be reviewed will include: -patient care outcomes -infection surveillance -staff training and education -patient safety *An effective and successful review of QAPI meeting and program activities will include: -analysis of QAPI tool -review of the results of required self-audits Review of the facility monthly clinical audit checklist for 12 months (May 22, 2023, through April 22, 2024) period, for cleaning and disinfection of dialysis station indicated 1 staff member per month was observed with 100% accuracy in the previous 10 months. Further review of the monthly clinical audit checklist for cleaning and disinfection of dialysis station failed to indicate which staff members were observed. During the survey 2 of 2 staff members (Registered Nurse (RN) #1 and RN #2) observed failed to adequately clean and disinfect the station for the next patient. During an interview on 5/15/24 at 1:15 P.M., the Facility Administrator (FA), agreed there were breaches in infection control policy during the survey observations, despite 100% compliance documented in the facility infection control audits. She further said only one staff member was observed per month and was not able to say which staff had been observed during the monthly audits of disinfection of the station.”