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 012509 (X3) Date Survey Completed 03/30/2023
Name of Provider or Supplier North Alabama Nephrology Center Street Address, City, State 1311 North Memorial Parkway #200, Huntsville, AL
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)
V0403 PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
CFR(s): 494.60(b)

The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.


This STANDARD is not met as evidenced by:
Based on observations, review of facility policies, Occupational Safety & (and) Health Administration (OSHA) guidelines, and interviews, it was determined the facility failed to ensure: a. Oxygen cylinders stored in the facility were secured and protected. b. Supplies available for patient use were not expired. This did affect two of two observations conducted and had the potential to negatively affect all patients who dialyze at this facility. Findings include: Facility Policy: Emergency Administration of Oxygen Reference Number: 47557 Version: 3 Published: 11/01/2021 Oxygen Cylinders Oxygen (O2) cylinders must be secured in an area where they will not fall. OSHA: Compressed Gas Safety General Safety Guidelines 2. Cylinder Storage Gas cylinders must be secured at all times to prevent tipping. Use appropriate material, such as chain, plastic coated wire cable, commercial straps ... to secure cylinders. ... Cylinders must be stored where they are protected from the ground to prevent rusting... Facility Policy: Storage of Supplies Version: 2 Published: 04/05/2021 Background: Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired... Policy ... Supplies must be rotated... to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date. 1. During the flash tour of the facility on 3/28/23 at 8:30 AM and during observations on 3/29/23 at 7:11 AM, the surveyor observed two upright, free-standing O2 cylinders in the medical records room, which was located inside the treatment floor. The O2 cylinders were not secure to prevent from tipping. Further observations during the flash tour of the treatment floor on 3/28/23 at 8:55 AM revealed the following supplies were expired: Supply Drawer Cabinet next to station 1: a. Male to Male Luer Adapters x (times) 51: expired 9/19/21 Supply Drawer Cabinets in the center isle: a. Male to Male Luer Adapters x 37: expired 4/17/22 Supply Drawers Cabinet located next to the medication preparation area: a. two packages of Oxygen Nasal Cannula Flared Tip: expired 7/15/22 b. two Yankauer Suction Instruments: expired 7/25/22 An interview was conducted on 3/28/23 at 9:00 AM with Employee Identifier (EI) # 2, Registered Nurse(RN), Charge Nurse (CN) who verified the supplies were expired and available for patient use. 2. During inspection of the isolation room supplies and equipment on 3/28/23 at 9:20 AM, the following supplies were observed in the supply cart as expired: a. Six male to male adapters: expired 9/19/21 b. One male to male adapter: expired 4/17/22 c. One Diasafe Plus filter expired: 4/30/22 In an interview conducted on 3/28/23 at 9:29 AM, EI # 2, who was present during the inspection, confirmed the isolation supplies were expired. An interview was conducted on 3/29/23 at 8:20 AM with EI # 2 who verified the O2 cylinders were not secured per facility policy and OSHA guidelines. 30952 41624