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 01C0001013 (X3) Date Survey Completed 06/12/2025
Name of Provider or Supplier Op Surg Ctr, Inc And Surgicare Of Huntsville, Inc Street Address, City, State 721 Madison Street, 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)
Q0101 PHYSICAL ENVIRONMENT
CFR(s): 416.44(a)(1)

The ASC must provide a functional and sanitary environment for the provision of surgical services. Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.


This STANDARD is not met as evidenced by:
Based on policy and procedure review, observations, and staff interviews, it was determined the clinic routinely used sterilization procedures intended for emergency use only. 

This deficient practice had the potential to negatively affect all patients served by the clinic. 

Findings include:

Policy Number: 503.0

Policy: Immediate Use Sterilization (This policy supersedes any previous policies of this nature.)

Date: Not listed

Definition: According to the Association of perioperative Registered Nurses (AORN), "immediate use is considered the shortest time possible between a sterilized items removal from the sterilizer and its aseptic transfer to the sterile field."

Policy: The policy outlines the procedure for the adequate sterilization of surgical instruments and equipment in the instance of emergency situations and/or when there is insufficient time to sterilize an item by the preferred prepackaged method and/or manufacturer's recommendations. 

I. Immediate use steam sterilization (IUSS) should be kept at a minimum.

II. IUSS shall only be used when there is not enough time to process the instruments by preferred wrapped or container method. 

...XI. When an item is flash sterilized, it must be documented in the IUSS Autoclave Log. The following information shall be documented:

A. Item(s) flash sterilized

B. Patient name

C. Type of cycle

D. Cycle parameters (temperature, duration of cycle)

E. Monitoring results

F. Date and time

G. Staff member name

H. Reason for IUSS

XII. At the conclusion of the sterilization process, the IUSS container must be immediately transferred from the sterilizer to the point of use.

...XIV. Items which have undergone IUSS shall be used immediately and not stored for later use... 

 


A tour of the Central Sterile Department was conducted on June 10, 2025 at 11:56 AM with Employee Identifier (EI) # 5, Central Sterile Coordinator. During the tour, the IUSS logbook was reviewed. 

Review of the logbook revealed nearly 400 instances of IUSS from January 2, 2025 through June 12, 2025 with approximately half of those being shoulder repair kits. 

An interview was conducted on 6/10/25 at 3:05 PM with EI # 5, who confirmed there were twelve shoulder repair kits and this was the standard amount the facility kept in stock for patient use.

Further review of the logbook revealed incomplete documentation throughout including: Item(s) flash sterilized, patient name, type of cycle, cycle parameters (temperature, duration of cycle)y, monitoring results, date and time, staff member name, and reason for IUSS.

An interview was conducted on 6/12/25 at 10:10 AM with EI # 20, Director of Quality Assurance and Performance Improvement and Infection Prevention, who confirmed the logbook was not being completed per their policy. EI # 20 also confirmed the facility would not be able to track infections using the incomplete documentation in the IUSS logbook and the facility was not providing adequate surgery kits to meet patient demands requiring IUSS.