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 01C0001002 (X3) Date Survey Completed 04/10/2025
Name of Provider or Supplier Mobile-Sc, Ltd Street Address, City, State 6144 A Airport Boulevard, Mobile, 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 facility policy and procedure, and interviews it was determined the facility failed to ensure opened single dose vials were not available for patient use and discarded per facility policy. 

This deficient practice had the potential to affect all patients served by this facility.

 Findings include:

Facility Policy: Safe Use of Single Dose, Single Use and Multi-dose Vials

Policy Number: None

Date Revised: 1-2025

Policy:

Mobile Surgery Center adheres to the CDC (Center for Disease Control) and USP (United States Pharmacopeia) regulations for safe use of single dose, single use, and multi-dose vials.

Procedure:

The following apply to the use of single dose...vials of medication.

I. Single Use Vials: A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a patient for a single case/procedure/injection...

A. If a single-dose...vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial will not be used for more than one patient nor stored for future use on the same patient.

B. ...the vial must be discarded at the end of the procedure and not stored for future use...


An observation of Operating Room (OR) # 3 conducted on 4/8/25 at 1:30 PM revealed an opened single-dose vial of 1 % (percent) Lidocaine Hydrochloride 50 mg (milligram) /5 ml (milliliter) in a locked narcotic box available for patient use. 

Employee Identifier (EI) # 6, OR Registered Nurse confirmed at the time of the observation the vial was opened and available for patient use and not discarded.