| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 01C0001011 | (X3) Date Survey Completed 12/07/2023 |
| Name of Provider or Supplier Gadsden Surgery Center, Ltd | Street Address, City, State 418 South 5th Street, Gadsden, 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) |
| Q0181 | ADMINISTRATION OF DRUGS CFR(s): 416.48(a) Drugs must be prepared and administered according to established policies and acceptable standards of practice. This STANDARD is not met as evidenced by: Based on observations, review of policy and procedure, Manufacturer Guidelines for Use, and interviews, it was determined the facility failed to ensure anesthesia medications requiring refrigeration were dated when removed from refrigeration resulting in the risk of administering medication with decreased potency. This did affect three of four observations and had the potential to negatively affect all patients served by this facility. Findings include: Facility Policy: Storage - Temp Control of Medications Policy Number:12002.5 Date Reviewed: 3/20/22 Policy: Drugs shall be stored properly, maintaining proper temperature in compliance with manufacturer specifications, to maintain potency and stability of the product. Procedure: ...Long Term Refrigeration Drugs requiring refrigeration for long term storage, but stored at room temperature for short periods ( e.g. Insulin, Succinylcholine,...) shall be destroyed when the recommended room temperature expiration date has expired. Manufacturers Guidelines for Use (package insert) for Rocuronium Bromide 50 milligrams (mg) / (per) milliliters (ml): ...16. How Supplied/Storage and Handling Rocuronium Bromide injection should be stored in a refrigerator, two degrees to eight degrees Centigrade (C), 36-46 degrees Fahrenheit (F). DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25 degrees C / 77 degrees F), use Rocuronium Bromide within 60 days. Use opened Rocuronium Bromide injection within 30 days. Manufacturers Guidelines for Use (package insert) for Succinylcholine Chloride 20 mg /10 ml. ...16. How Supplied/Storage and Handling Refrigeration of undiluted Succinylcholine Chloride Injection, USP (United States Pharmacopeia) will assure full potency until expiration date. All units carry a date of expiration. Store in refrigerator two degrees to eight degrees C (36 degrees to 46 degrees F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. 1. An inspection of the anesthesia cart in OR (operating room) # 1 was conducted on 12/5/23 at 11:58 AM with Employee Identifier (EI) # 2, OR Manager. The following medications were observed in the drawer of the cart and available for patient use: One unopened vial of Rocuronium Bromide 50 mg/5 ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. One unopened vial of Succinylcholine Chloride 20 mg/ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. EI # 2 confirmed at the time of the observation, there was no date written on the vials to indicate when they had been removed from refrigerated storage or when they would expire. 2. An inspection of the anesthesia cart in OR # 2 was conducted on 12/5/23 at 12:09 PM with EI # 2. The following medications were observed in the drawer of the cart and available for patient use. One unopened vial of Rocuronium Bromide 50 mg/ 5 ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. One unopened vial of Succinylcholine Chloride 20 mg/ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. EI # 2 confirmed at the time of the observation, there was no date written on the vials to indicate when they had been removed from refrigerated storage or when they would expire. 3. An inspection of the anesthesia cart in OR # 3 was conducted on 12/5/23 at 12:20 PM with EI # 2 and EI # 9, CRNA (Certified Registered Nurse Anesthetist). The following medications were observed in the drawer of the cart and available for patient use. Two unopened vials of Rocuronium Bromide 50 mg/ 5 ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. One unopened vial of Succinylcholine Chloride 20 mg/ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. EI # 2 and EI # 9 confirmed at the time of the observation, there was no date written on the vials to indicate when they had been removed from refrigerated storage or when they would expire. |