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 01C0001010 (X3) Date Survey Completed 01/04/2024
Name of Provider or Supplier The Southern Alabama Surgery Center, Llc Street Address, City, State 2800 Ross Clark Circle, Suite 3, Dothan, 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)
Q0241 SANITARY ENVIRONMENT
CFR(s): 416.51(a)

The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.


This STANDARD is not met as evidenced by:
Based on observation, review of Centers for Disease Control and Prevention (CDC) Hand Hygiene in Healthcare Settings guidelines, CDC Health Update, an SuperNova .25 (Brand) Multi-Enzymatic Manufacture's Specifications, it was determined the facility failed to ensure the staff:



Followed the CDC guidelines for hand hygiene.
Used the correct dilution rate of SuperNova .25 for instrument cleaning.
Were provided education and demonstrated competency prior to staff performing the reprocessing of surgical instruments.

This did affect Patient Identifier (PI) # 19 and PI # 20, two of two surgical procedures observed, and had the potential to negatively affect all patients served by this facility.


Findings include:


CDC Hand Hygiene in Healthcare Settings


Review Date: 1/30/2020


Hand Hygiene Guidance


...Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications:


Immediately before touching a patient.


...After touching a patient or the patient's immediate environment.


After contact with blood, body fluids, or contaminated surfaces.


Immediately after glove removal.


CDC Health Update


Distributed Date: 10/2/15


CDC/FDA (Federal Drug Administration) Health Update about the Immediate need for healthcare facilities to review procedures for cleaning, disinfecting, and sterilizing reusable medical devices.


...Training...Healthcare faclities should provide training to all personnel who reprocess medical devices.


Training should be required and provided:


Upon hire or prior to provision of services at the facility.


At least once a year...


SuperNova .25 Multi-Enzymatic Specifications


Review date: 9/19


...Directions for Use:


...Dilution rate...0.8 ml/l (milliliters per liter) in automated washers using high purity (...distilled) water.


Diluation rate...2ml/l using tap water for manual and automated use.


1. An observation was conducted on 1/3/24 of a Right Eye Phacoemulsification of Cataract with Intraocular Lens Insertion on PI # 19.


At 8:45 AM, Employee Identifier (EI) # 3, RN (Registered Nurse), obtained Intravenous (IV) placement on PI # 19, removed gloves, proceeded to don clean gloves and obtain tape to secure the IV site. EI # 3 failed to perform hand hygiene after gloves were removed and clean gloves donned. PI # 19 was placed in preoperative bay 3 which had a hand sanitizer station located on the wall.


At 9:08 AM, EI # 4, RN, administered eye drops to PI # 19's right eye, placed the eye drops in the supply cabinet of the OR (Operating Room), removed gloves, documented on the medical record, then proceeded to obtain and open a sterile lens package. EI # 4 failed to perform hand hygiene after gloves were removed and prior to obtaining and opening the sterile lens package. PI # 19 was placed in OR 3 which had two hand sanitizer stations were located on the wall by each door of the OR and one station on the anesthesia cart.


EI # 4 then donned gloves, opened iodine swab stick package and proceeded to clean PI # 19's right eye with three swab sticks. EI # 4 failed to perform hand hygiene prior to opening clean supply and cleaning PI # 19's right eye.


After documenting on the medical record, EI # 4 donned gloves without performing hand hygiene and removed an instrument from the Centurion Vision System (machine used in operation). EI # 4 failed to perform hand hygiene after contact with the PI # 19's medical record in the patient's immediate environment and prior to removing an instrument used on the vision system, which continued to be actively in use for the surgery.


An interview was conducted on 1/4/24 at 4:15 PM with EI # 1, Administrator, who confirmed EI # 3 and EI # 4 failed to perform hand hygiene per the CDC guidelines.


2. An observation was conducted on 1/3/24 at 1:46 PM of a Right Eye Phacoemulsification of Cataract with Intraocular Lens Insertion on PI # 20


EI # 6, RN, administered eye drops to PI # 20's right eye then removed gloves, and assisted the physician with donning a sterile gown. EI # 6 failed to perform hand hygiene after glove removal and prior to assisting the physician with sterile gowning.


EI # 6 performed documentation in medical record, obtained gauze, then cleaned the betadine used in procedure off of PI # 20's right eye without performing hand hygiene. EI # 6 failed to perform hand hygiene immediately before touching a patient. EI # 6 then proceeded to leave OR without performing hand hygiene. PI # 20 was placed in OR 2 which had a hand sanitizer station located by the exit door and on the anesthesia cart.


After the surgical procedure was completed, EI # 7, Surgeon, removed the gown and gloves used for the procedure and exited the OR without performing hand hygiene. PI # 20 was placed in OR 2 which had a hand sanitizer station located by the exit door and on the anesthesia cart.


At 2:10 PM, EI # 8, Technician, obtained the surgical instruments used in the procedure. EI # 8 placed each instrument in a basin filled with one liter of distilled water and when asked how much solution was added EI # 8 stated, "like seven pumps" of SuperNova .25 Multi-Enzymatic solution. Each instrument was then brushed and packaged to place in the sterilizer. EI # 8 failed to use dilution ratio of 0.8 ml/l for the SuperNova .25 solution per the manufacture's specifications.


An interview was conducted on 1/4/24 at 12:34 PM with EI # 9, Scrub Technician Supervisor, who confirmed each pump of the SuperNova solution was 1 ml and adding seven pumps to one liter of water "would be too much" and "could eat away at the instruments."


An interview was conducted on 1/4/24 at 4:15 PM with EI # 1, who confirmed EI # 7 failed to perform hand hygiene per the CDC guidelines.


3. Review of EI # 8's personnel file on 1/4/24, revealed no documentation EI # 8 had been provided education and demonstrated competency on the reprocessing of sterile instruments.


An interview was conducted on 1/4/24 at 4:37 PM with EI # 1, who confirmed there was no documentation EI # 8 had been provided education and demonstrated competency on the reprocessing of sterile instruments.