Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 852587 (X3) Date Survey Completed 02/07/2025
Name of Provider or Supplier Fresenius Kidney Care Richmond County Street Address, City, State 2556 Tobacco Road Suite A, Hephzibah, 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)
E0028 Dialysis Emergency Equipment

ยง494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.


This STANDARD is not met as evidenced by:
Based on observation, a review of Food and Drug Administration (FDA) Guidelines, staff interview, a review of Centers for Disease Control and Prevention (CDC) Recommendations, and a review of facility Policies and Procedures (P&P), it was determined that the facility failed to ensure that two of two Registered Nurses, (RN), (RN AA and RN BB), who were responsible for administering medications, discarded and not made available for use, an opened and expired vial of Tuberculin Purified Protein Derivative (PPD Mantoux - a diagnostic antigen to aid in the detection of infection with Mycobacterium Tuberculosis) testing, in accordance with the manufacturer's set time frames for use, as well as other expired medications in one of one Medication Refrigerator, in one of one Emergency Cart, and in one of one Medication Cabinet. This failure had the potential to negatively affect the health and safety of 37 in-center hemodialysis patients who were under the care of this facility. Findings include: During a tour of the Patient Treatment Room with the Facility Administrator on 2/5/25 between 10:15 a.m. and , the following was revealed: In the Medication Refrigerator: - There was an opened and accessed vial of Tuberculin PPD Mantoux, which was dated as first opened on 2/23/24, (348 days since first opened). - A review of FDA guidelines stated: A vial of Tuberculin PPD (Mantoux) Tubersol, which has been entered and in use for 30 days should be discarded... Do not use after expiration date. In the Medication Cabinet of the Medication Room: - 24 bottles of Calcium Gluconate (for the treatment of low calcium), 100 milligrams [mg] per 10 milliLiters [mL] per bottle, expired 10/2024. - 10 vials of Cefepime (an antibiotic), 1gram [gm] per vial, expired 10/2024. - 16 bottles of Sodium Bicarbonate (used to treat or prevent excess acid in the blood or urine), 50 milliEquivalent [mEq] per 50 mg, expired 10/2024. In the Emergency Crash Cart: - Two vials of Benadryl (antihistamine), 50 mg/mL, expired 11/2024. The Facility Administrator stated on 2/5/25 at 10:30 a.m. that the nurses should have caught this. - According to CDC Guidelines, multi-dose vials typically contain an antimicrobial preservative to help prevent the growth of bacteria. If a multi-dose vial has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. - A review of the facility's Policy: 47488, Version 9, titled, "Medication Preparation and Administration", with latest revision date of February 6, 2023 stated: - Expiration date for all stored medications are to be monitored on a monthly basis. Any open multi-dose vials must be discarded 28 days after opening or per manufacturer's expiration date.