Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852557	(X3) Date Survey Completed 03/22/2023
Name of Provider or Supplier Fresenius Kidney Care Glynn County	Street Address, City, State 3150 Glynn Avenue, Brunswick, GA
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.

(X4) ID Prefix Tag	Summary Statement of Deficiencies (Each deficiency should be preceded by full regulatory or LSC identifying information)
E0000	A Recertification Survey was conducted at Fresenius Kidney Care Glynn County from March 20, 2023 through March 22, 2023. The survey revealed that the facility was in compliance with 42 CFR Part 494.62, Conditions for Coverage for Emergency Preparedness Plan for End Stage Renal Disease facilities. No deficiencies were cited.
V0000	A Recertification Survey [CORE] was conducted at Fresenius Kidney Care Glynn County from March 20, 2023 through March 22, 2023. The survey revealed that the facility was in substantial compliance with 42 CFR Part 494 Conditions for Coverage for End Stage Renal Disease Facilities. However, the following deficiencies resulted from the facility's noncompliance related to the survey:
V0117	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: Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and staff interview, it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse (RN AA) observed, utilized appropriate infection control techniques to prevent cross contamination. This breach in infection control techniques could negatively affect the health and safety of one of one patient (P# 9), who was undergoing hemodialysis (HD) treatment with central venous catheter (CVC - dialysis access) at the time of this observation. Findings include: During observation in the patient treatment room on 3/21/23 between 9:30 a.m. and 10:30 a.m., the following was observed: - RN AA was observed during initiation of HD treatment on P#9 with a CVC at Station 5. She placed the used blood tubes (contaminated) on the blue liner that stored clean/sterile supplies such as Heparin-lock syringes, gauze pads, and alcohol pads. According to the CDC, measures to prevent contamination of clean or sterile items include not storing potentially contaminated (used) supplies in areas where clean (unused) supplies are handled. During an interview with the Clinic Manager on 3/21/23 at approximately 11:30 a.m., she stated that the nurse should have separated the clean supplies from the dirty/contaminated supplies to prevent cross contamination.
V0121	IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This STANDARD is not met as evidenced by: Based on observation, a review of facility policies and procedures and Centers for Disease Control and Prevention (CDC) guidelines, and staff interview, it was determined that the Infection Control Committee failed to ensure that the staff followed the facility's infection control policies, to prevent cross contamination and the spread of infections. The facility failed to clean and disinfect multiple blood splatters on the outside of six of 17 sharps containers that were attached to the hemodialysis machines at Stations (S) 2, 4, 5, 8, 15 and 16 in one of one patient treatment room. Findings include: During a tour of the patient treatment room on 3/20/23 between 1:30 p.m. - 2:30 p.m., it was observed that the sharps containers attached to the side of the hemodialysis machines in S2, S4,S5, S8, S15, and S16, were more than 2/3 full and had multiple blood splatters on the outside of the containers. The blood splatters were not cleaned and wiped with a disinfectant cloth during the observation. A review of policy titled, "Medical Waste Management Plan" dated 7/31/21 stated that all sharps container must be replaced when they are 2/3 to 3/4 full. A review of policy FMS-CS-11-155-110A titled, "Cleaning and Disinfection of Dialysis Station" dated July 1, 2019 paragraph titled, "Work Surface Cleaning and Disinfection with Visible Blood" stated that after cleaning up all visible blood, use a new cloth wet with 1:100 bleach solution for a second cleaning of the surface. According to CDC guidelines, failures in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections, from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces) must be performed between patients uses to prevent transmission of dangerous pathogens. During an interview with the Clinic Manager on 3/21/23 at approximately 4:00 p.m., she stated that the staff should have used a separate bleached cloth to clean and disinfect the surfaces of the sharps containers at the patient stations and emptied the containers.
V0506	PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient's comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This STANDARD is not met as evidenced by: Based on a review of the Centers for Disease Control and Prevention (CDC) recommendations, medical records review, and staff interview, it was determined that the Infection Control Committee failed to ensure that two of two patients sampled for anemia (P#1 and P#2) received a tuberculin (TB) skin test (an injection under the skin to determine if the patient is positive for tuberculosis). This deficient practice had the potential to negatively affect the health and safety of the 55 patients who dialyzed at this facility. Findings include: A review of the CDC recommendations stated that all dialysis patients, be tested at least once for baseline tuberculin skin test results (TST) and re-screened if TB exposure is detected. Chest x-rays may be used for individuals for whom the TST is not an option. A review of P#1 and P#2's medical records revealed that P#1 and P#2 did not receive an annual TB skin test or TB questionnaire for 2022 - 2023. During an interview with the facility Clinic Manager on 2/21/23 at approximately 2:30 p.m. she stated that the TB testing should have been completed for P's#1 and P#2.
V0632	QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This STANDARD is not met as evidenced by: Based on a review of Dialysis Facility Report (DFR) and facility records and staff interview, it was determined that the facility failed to track and trend anemia rates (low red blood cell counts) and develop action plans and outcomes, to evaluate the effectiveness of the facility's management of patients with a Hemoglobin (Hgb - protein in red blood cells that carries oxygen) of less than (<) 10 g/dL, for six of six months of Quality Improvement Meeting Minutes reviewed (September 2022 - May 2023). This deficient practice had the potential to negatively affect the health and safety of the 55 patients who were receiving dialysis services at this facility. Findings were: A review of 2022 DFR (A report prepared by Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.) revealed that the average Hgb < 10 g/dL should not exceed 16.8 % for in-center hemodialysis patients. A review of Quality Improvement Meeting reports for six of six months (September 2022 - May 2023) revealed that the facility's average percentage for Hgb < 10 g/dL was 30.6 % for in-center dialysis patients. The Quality Improvement Meeting minutes revealed a lack of documented evidence that anemia management for patients with a Hgb < 10 g/dL had appropriate action plans, root cause analysis, and follow-up evaluations to ensure improvement. During an interview with the Clinic Manager on 3/22/23 at approximately 3:00 p.m., she stated that the anemia management for patients with Hgb <10 were being reviewed. However, the action plans, root cause analysis and follow-up evaluation needed to be completed.
V0715	MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This STANDARD is not met as evidenced by: Based on a review of facility records and staff interview, it was determined that the facility failed to conduct regular fire drills at least every six months for 12 of 12 months of fire drill records reviewed (3/1/22 - 3/1/23). Failure to conduct periodic fire drills for each shift of patients, had the potential to negatively affect the health and safety of the 55 patients who were dialyzing at this facility. Findings were: A review of the facility fire drill records from 3/1/22 to 3/1/23, showed a lack of documented fire and evacuation drills for each shift of patients for the last twelve months. The last documented fire drill was completed on 2/23/22. A review of the policy titled, "Fire Drill" dated 8/2/17, stated fire drills shall be performed quarterly for each shift of patients and staff. During an interview with the Clinic Manager on 3/21/23 at approximately 2:30 p.m., she stated that the fire drills should have been conducted quarterly.