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 852550 (X3) Date Survey Completed 06/09/2022
Name of Provider or Supplier Dublin Kidney Institute Street Address, City, State 207 Industrial Blvd Ste 2, Dublin, 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 facility records, a review of the Food and Drug Administration (FDA) recommendation, and staff interview, it was determined that the facility failed to ensure that all emergency drugs and other stored medications, should not be out of date and should be stored and maintained according to the manufacturer's instructions. This deficient practice had the potential to negatively affect the health and safety of all 16 Home Peritoneal Dialysis (PD) patients (P#1-P#4, P#6 - P#17) and one Home Hemodialysis (HHD) patient (P#5) who were under the care of this facility. Findings include: During a tour of the facility with Registered Nurse (RN AA) on 6/7/22 at 5:20 p.m., the following medications were expired, thus these were not suitable for use. At the Crash Cart: - Naloxone HCl Injection (medication used to rapidly reverse opioid overdose) 0.4 mg/mL (five vials) - expired 5/2022 - Epipen Abboject Injection (for the treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, food, or other substances) 1mg/10 mL glass Abboject (total of six) - expired 5/1/2022. RN AA acknowledged the expiry dates of these medications on 6/7/22 at 5:20 p.m. and she stated that she was unaware that the medications were expired. A review of facility records revealed that there was no available facility policy and procedure (P & P) regarding expired medications. According to FDA recommendation dated 2/8/2021, drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medicine... Once the expiration date has passed there is no guarantee that the medicine will be safe and effective.