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 01C0001000 (X3) Date Survey Completed 11/16/2023
Name of Provider or Supplier Montgomery Surgical Center Llc Street Address, City, State 470 Taylor Road, Montgomery, 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:


1. Medications were stored in a locked and secure area resulting in the risk of medication misuse.


2. Anesthesia medications requiring refrigeration were dated when removed from refrigeration resulting in the risk of administering medication with decreased potency.


This did affect four of four observations and had the potential to negatively affect all patients served by this facility.


Findings include:


Facility Policy: Safe Injection, Infusion, and Medication Vial Practices


Policy Number: None


Date Reviewed: 1/23


Policy: Safe injection, infusion and medication vial practices shall be followed and adherence monitored.


Procedure:


A. Aseptic Technique


...4. Staff store, access, and prepare medications and supplies in a clean area on a clean surface.


...F. Medication Vials


1. Always follow manufacturer's Instructions for storage and use


Manufacturers Guidelines for Use (package insert) for Rocuronium Bromide 50 milligrams (mg) / (per) milliliters (ml):


Rocuronium Bromide 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 within 30 days.


Manufacturers Guidelines for Use (package insert) for Succinylcholine Chloride 20 mg /10 ml.


Refrigeration of undiluted Succinylcholine Chloride Injection, USP (United States Pharmacopeia) will assure full potency until expiration date.


Store refrigerated 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.





2. An inspection of the anesthesia cart located in OR 8 was conducted on 11/14/23 at 2:40 PM with EI # 5, CRNA (Certified Registered Nurse Anesthetist). The following refrigerated medications were observed in the top drawer of the cart and available for patient use:


Five unopened vials of Rocuronium Bromide 50 mg/ 5ml. 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 # 5 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 located in OR 6 was conducted on 11/14/23 at 3:00 PM with EI # 5. The following refrigerated medications were observed in the top drawer of the anesthesia cart and available for patient use.


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.


Five unopened vials of Rocuronium Bromide 50 mg/5 ml. There was no date written on the vial to indicate when it had to been removed from refrigerated storage or when it would expire.


EI # 5 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.


4. An inspection of the anesthesia cart located in OR 4 was conducted on 11/14/23 at 3:38 PM. with EI # 5. Eleven unopened vials of Succinylcholine Chloride 20 mg/ml were observed in the top drawer of the anesthesia cart and available for patient use. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire.


EI # 5 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.




1. A tour was conducted of the Pre- Op (Operative) area on 11/14/23 at 9:43 AM. The following medications were not stored in a secured and locked area:


Top of anesthesia block cart located outside of the medication room


a. Two unopened vials of Ropivacaine Hydrochloride Injection 0.5 % 20 ml, 100 mg /20 ml single dose vials and three unopened Ropivacaine Hydrochloride Injection 0.5 % 30 ml, 150mg/30ml single dose vials.


Nurses station countertop located in baskets


a. 13 vials of Cefazolin 1 gm (gram) with IV (intravenous) bags of Dextrose 50 ml, for IV injection use only.


b. 22 vials of Cefazolin 1 gm per vial for injection.


An interview was conducted on 11/14/23 at 10:06 AM with Employee Identifier (EI) # 2, Peri-anesthesia Nurse Manager (PNM), who verified the staff failed to secure the mediations in a locked and secure area.