Fresenius Medical Care King George

“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: 46466 Based on observations and document review, it was determined that the facility’s staff failed to properly perform hand hygiene when touching the dialysis machines. The findings included: On 1/17/24 at 12:15 p.m., the surveyor observed Staff Member #5 (SM5) touching the dialysis machine at patient station #16 without wearing gloves. SM5 performed hand hygiene after touching station #16, then walked over to another patient station and touched the machine while using a single glove to cover the tip of SM5’s finger. SM5 was not wearing the glove on SM5’s hand. A review of the facility’s policy “Cleaning and Disinfecting the Dialysis Station”, published 9/5/23, stated in part “...Electronic Charting Device Integrated into the Dialysis Machine. The electronic charting device incorporated in the 2009 T dialysis machine is not considered a clean area. Gloves will be required when touching either the screen or keyboard...”. The findings were discussed with Staff Members #1,#3 and #13 at the exit conference on 1/18/24 at 2:00 p.m. 49355 Based on observation, interviews and review of the documentation, it was determined that staff failed to follow the facility’s policy on hand hygiene to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. The findings include: On 01/17/2024 between the hours of 10 a.m. and 12:30 p.m., both surveyors observed Staff Member #4 (SM4) fail to change gloves and perform hand hygiene, per the facility’s policy, multiple times. At 11:03 a.m., SM4 prepared heparin for a patient at station 13. SM4 did not change gloves or perform hand hygiene before administering the medication to the patient via fistula. At 12:01 p.m., SM4 was observed leaving a patient’s station, removing gloves, but did not use hand sanitizer and then walked to the office of SM1. SM4 was observed sitting down, with gloves on, touching glasses and then returning to the patient’s station, never changing gloves or performing hand hygiene prior to patient contact. Interviews with SM1 and SM7 confirmed the need to change gloves and perform hand hygiene before donning a new pair of gloves. The above concerns were discussed with Staff Members # 1, #3, and #13 at the exit conference on 01/18/2024 at 2:00 p.m.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 46466 Based on observations and facility document review, the facility staff failed to don and doff Personal Protective Equipment (PPE) when caring for a COVID-19 positive patient. The findings include: On 1/17/24 between 10:10 a.m. and 11:25 a.m., Staff Member #9 (SM9) was observed three (3) separate times entering and exiting the isolation room to care for a COVID-19 positive patient. Each time, SM9 entered the isolation room without removing their gown used on the treatment floor. SM9 cared for the patient and when SM9 left the isolation room, SM9 left the gown on and continued to care for other non-isolated patients on the treatment floor. A review of the facility’s policy “Guidance on Dialyzing and Infection Control Practices of COVID-19 in (facility’s name) Dialysis Clinics”, published 7/3/23, stated in part: “...If there are shared staff members between the PUI and COVID-19 classifications and negative patients, the staff member must wear dedicated PPE in caring for the COVID-19 positive and PUI patients. The dedicated PPE should remain within the isolation cohort area and be donned when caring for the isolation cohort of patients and doffed when moving to care for non-isolation patients...”. The findings were discussed with Staff Members #1,#3 and #13 at the exit conference on 1/18/24 at 2:00 p.m.”

“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: 46466 Based on interview and medical record review, the facility failed to provide evidence that patients were provided the Hepatitis B vaccine for one (1) of four (4) in-center hemodialysis patient records sampled. Patient #1 The findings include: On 1/18/24 the surveyors reviewed four (4) in-center hemodialysis patient medical records. Patient #1 (P1) was tested for Hepatitis B virus prior to P1’s initiation of dialysis treatment. P1’s result revealed that P1 was susceptible to the virus. P1’s medical record did not contain evidence that P1 was offered hepatitis B vaccine or that P1 declined to be vaccinated. While navigating the chart with Staff Member #1 (SM1), SM1 was not able to locate a physician order for the vaccine. SM1 confirmed that P1 should have documentation in their chart that the vaccine was either offered or declined. SM1 also stated that the staff will make sure that P1 was offered the vaccine when P1 returned for the next dialysis treatment. The above concerns were discussed with Staff Members #1, #3 and #13 at the exit conference on 1/18/24 at 2:00 p.m.”

“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: 46466 Based on observations and facility document review, it was determined that the facility staff failed to maintain a safe environment for dialysis patients and staff by not properly labeling opened medications per the facility’s policy. The findings include: On 1/17/24 at 11:30 a.m., the surveyor observed one intravenous (IV) medication syringe laying on the chairside table of station #15. The syringe was labeled with the medication name, route, dose, and initials of the person who prepared the medication, but failed to provide the date and time that the medication was drawn. A review of the facility’s policy titled, “Medication Preparation and Administration”, published 2/6/23, stated in part: “...All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication...” The above concerns were discussed with Staff Members #1, #3 and #13 at the exit conference on 1/18/24 at 2:00 p.m. 49355 Based on observations, interview and document review, it was determined the facility staff failed to comply with the facility’s policy on medication preparation and administration. Findings: During the flash tour on 01/17/2024 at 10:15 a.m.., the surveyor observed a opened multidose vial of heparin in the medication preparation area. The vial label contained initials and date the vial was opened but the time of opening of the vial was not written on the label. On 01/17/2024 at 11:03 a.m., the surveyor observed Staff Member #4 (SM4) administer heparin to a Patient #6 at station #13. SM4 did not disinfect the cannula port prior to injecting the heparin. A review of the facility’s policy titled “Medication Preparation and Administration” last reviewed 02/06/2023 stated, in part: “... Labeling Vials * When preparing medications if the vial is not used immediately in it entirety, the nurse or PCT ... must place the date and time the vial was opened on the medication label along with their initials. Note: to ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened. *Label any opened multi-dose vial that is not used immediately and store vial accordingly.” “... Infection Control * Disinfect IV ports prior to accessing, using friction and 70% alcohol.... Allow to dry prior to accessing.” The above concerns were discussed with SM1, 3, and 13 at the exit conference on 01/18/2024 at 2:00 p.m.”

“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: 46466 Based on medical record and facility document review, the facility staff failed to ensure that two (2) of four (4) patients included in the survey sample were monitored according to facility policy during their dialysis treatment. Patient #2 and Patient #3 The findings include: On 1/18/24, the surveyor conducted medical record reviews of four (4) in-center hemodialysis patients. Review of the medical records determined that the staff failed to include documentation of notification to the registered nurse for abnormal findings for intra-dialysis pulse for Patient #2 (Pt. 2) and blood pressures for Patient #3 (Pt. 3) as per the facility’s policy. The surveyor reviewed Pt.2’s six (6) treatment flow sheets from 10/18/23 through 12/11/23 and found the following; On 10/18/23, Pt. 2 had a documented pulse rate above 100 beats per minute. On 12/1/23, Pt. 2 had a documented pulse rate above 100 beats per minute. The surveyor reviewed Pt.3’s six (6) treatment flow sheets from 1/3/24 through 1/15/24 and found the following: On 1/5/24, Pt. 3 had a documented blood pressure of 85/46 at 1:37 p.m. and 95/49 at 2:10 p.m. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...During Treatment...Blood Pressure...Report to the nurse:...Blood Pressure less than or equal to 100 mm/hg systolic. Pulse...Report to the nurse patients whose heart rates have dropped below 60, risen above 100...”. The above concerns were discussed with Staff Member #1 on 1/18/24 at 1:10 p.m. and again with Staff Members #1, #3 and #13 at the exit conference on 1/18/24 at 2:00 p.m.”

“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: 46466 Based on medical record and facility document review, the facility staff failed to follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) for one (1) of four (4) in-center dialysis patients included in the survey sample. Patient #3 The findings included: The surveyor reviewed Patient #3’s six (6) dialysis treatment records from 1/3/24 through 1/15/24. Pt. #3 treatment record evidenced an order for dialysis treatment prescription with BFR of 450. Three (3) of six (6) treatment sheets evidenced the following: On 1/5/24, the BFR was documented as 300. On 1/12/24, the BFR was documented as 350. On 1/15/24, the BFR was documented as 400 Pt. #3’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...3. Machine Parameters and Extracorpeal Circuit - Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow...”. The above concerns were discussed with Staff Members #1, #3 and #13 at the exit conference on 1/18/24 at 2:00 p.m.”