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 852551 (X3) Date Survey Completed 01/15/2025
Name of Provider or Supplier Duluth Dialysis Street Address, City, State 3170 Peachtree Ind Blvd, Ste 100, Duluth, 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, staff interview, a review of the Food and Drug Administration (FDA) recommendations and a review of facility Policy and Procedures (P&P) it was determined that the facility failed to ensure that expired medications in one of one Evacuation Kit were removed and not made available for use. This deficient practice had the potential to negatively affect the health and safety of 32 in-center hemodialysis patients who were under the care of this facility. Findings include: During a tour in the Patient Treatment Room on 1/13/25 from 10:14 a.m. though 10:55 a.m., the following medications and supplies had expired, thus these were not suitable for use. In the Evacuation Kit: -One Muli-dose vial of Heparin 30 Heparin Sodium 30,000 Units/30 mL (milliliter) 1000 Units/mL expired 8/16/24. - 9 bags of 0.9% Sodium Chloride Injection, USP 1000mL expired 1/2024 On 1/13/25, Facility Administrator (FA) acknowledged these findings at 10:55 a.m. According to FDA recommendations dated 2/8/21, drug and supplies' 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 medication or using expired supplies. Once the expiration date has passed there is no guarantee that the medicine or supplies will be safe and effective. A review of facility Policy: 1-06-01, titled, "Medication Policy" with latest revision date of October 2023, stated: 13. All open or unopened medication packages (i.e. vials, ampules, etc.) are stored according to the manufacturer's directions. Do not use any medication that has been stored improperly or has expired. A review of facility Policy: 4-07-01, titled, "Facility Emergency Management Plan" with latest revision date of October 2024, stated: Emergency Evacuation Kit 7. FA or designee will review the contents of the kit(s) and replace missing or expired supplies at least monthly.