Statement of Deficiencies

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)
E0000	A recertification survey was conducted 6/10/25 to 6/12/25 and The Surgery Center of Huntsville was found to be in substantial compliance with the Conditions for Coverage for Emergency Preparedness.
Q0000	A recertification survey was conducted 6/10/25 to 6/12/25 at The Surgery Center of Huntsville. The facility was found to be not in compliance with the Condition for Coverage at 42 CFR 416.44: Environment. Standard level deficiencies were also cited.
Q0100	ENVIRONMENT CFR(s): 416.44 The ASC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients. This CONDITION is not met as evidenced by: Based on observations during the facility tour with the Surgery Center of Huntsville's staff and the Life Safety Officer, it was determined the facility was not constructed, arranged, and maintained to ensure patient safety. This had the potential to negatively affect all patients, staff, and visitors of the facility. Findings: Refer to Q101 and Life Safety Code violations on additional 2567
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.
Q0221	NOTICE OF RIGHTS CFR(s): 416.50(a) §416.50(a) Standard: Notice of Rights An ASC must, prior to the start of the surgical procedure, provide the patient, the patient’s representative, or the patient’s surrogate with verbal and written notice of the patient’s rights in a language and manner that ensures the patient, the representative, or the surrogate understand all of the patient’s rights as set forth in this section. The ASC’s notice of rights must include the address and telephone number of the State agency to which patients may report complaints, as well as the Web site for the Office of the Medicare Beneficiary Ombudsman. This STANDARD is not met as evidenced by: Based on the posted Patient Rights and Responsibilities framed document, and staff interview, it was determined the facility failed to include the correct State Agency Hotline phone number 1 (800) 356-9596 as part of the contact information for grievances and complaints. This deficient practice had the potential to negatively affect all patients served by this facility. Upon entrance to the facility on 6/10/25 at approximately 9:15 AM, an observation of the posted Patient Rights and Responsibilities framed document located in the facility lobby revealed the State Agency Hotline phone number was incorrect. An interview was conducted on 6/12/25 at 2:40 PM with Employee Identifier (EI) # 1, Director of Nursing, who confirmed the incorrect phone number was posted.
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 observations, review of facility policy and procedure, and staff interviews, it was determined the facility failed to ensure staff performed hand hygiene per facility policy. This did affect Patient Identifier (PI) # 19, one unsampled patient, PI # 20, and had the potential to affect all patients served by the facility. Findings include: Facility Policy: Hand Hygiene Policy Number: 116.0 Date: Not Listed Purpose: To provide guidelines for effective hand hygiene, in order to prevent the transmission of bacteria, germs, and infections. Policy: All members of the healthcare team will comply with current Centers for Disease Control and Prevention (CDC) and AORN (Association of periOperative Registered Nurses) hand hygiene guidelines on when to use non-bacterial soap and water, an antimicrobial soap and water or an alcohol-based hand rub. Procedure: I. Indications For Handwashing ...C. Hand-washing may also be used for routinely decontaminating hands in the following clinical situations: 1. Before having direct contact with patients. 2. Before inserting indwelling urinary catheters, peripheral vascular catheters, or other invasive devices that do not require a surgical procedure. 3. After contact with a patient's intact skin (e. g. [for example], when taking a pulse or blood pressure, and lifting a patient). 4. After contact with body fluids or excretions, mucous membranes, non-intact skin and wound dressings... 5. When moving from a contaminated body site to a clean body site during patient care. 6. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. 7. After removing gloves. II. Indications for Hand-rubbing A. If hands are not visibly soiled, an alcohol-based hand sanitizer containing 60-95 % (percent) may be used for routinely decontaminating hands in the following clinical situations: 1. Before having direct contact with patients. 2. Before inserting indwelling urinary catheters, peripheral vascular catheters, or other invasive devices that do not require a surgical procedure. 3. After contact with a patient's intact skin (e. g. [for example] , when taking a pulse or blood pressure, and lifting a patient). 4. After contact with body fluids or excretions, mucous membranes , non-intact skin and wound dressings... 5. When moving from a contaminated body site to a clean body site during patient care. 6. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. 7. After removing gloves. III. Non-Surgical Hand Hygiene Technique ...D. Gloves and Hand Hygiene: ... 1. Wear gloves when contact with blood or other potentially infectious materials (other body fluids, secretions and excretions), mucous membranes, non-intact skin and contaminated items will or could occur. 2. Change gloves during patient care if moving from a contaminated body site to a clean body site. 3. Remove gloves promptly after use, before touching non-contaminated items and environmental surfaces, and before caring for another patient 4. Decontaminate hands after removing gloves. 2. An observation was conducted on 6/10/25 at 10:13 AM. EI # 16, PACU Technician, obtained Vesa Sure disinfectant wipes, cleaned a dirty bed mattress, handrails, pillow and blood pressure cuff. EI # 16 obtained a clean sheet with contaminated gloves and placed on the cleaned bed. EI # 16 failed to remove the contaminated gloves and perform hand hygiene before he/she obtained a clean sheet. EI # 16 then gathered two dirty linen bags and carried them to the soiled utility room. EI # 16 returned to the PACU bed cleaning section, removed contaminated gloves and without performing hand hygiene donned clean gloves. EI # 16 then obtained Vesa Sure disinfectant wipes, wiped the next bed mattress, handrails, pillow and blood pressure cuff. EI # 16 failed to perform hand hygiene after the removal of contaminated gloves. An interview was conducted on 6/10/25 at 10:20 AM with EI # 22, RN, who confirmed EI # 16 failed to remove contaminated gloves and perform hand hygiene per facility policy. 3. An observation was conducted on 6/11/25 at 8:05 AM. EI # 15, RN took PI # 20's vital signs, cleaned vital sign equipment with Clorox wipes. EI # 15 then removed contaminated gloves, without performing hand hygiene applied clean gloves and assessed PI # 20's right arm for IV catheter insertion. An interview was conducted on 6/12/25 at 2:40 PM, EI # 1, who confirmed the staff failed to perform hand hygiene per facility policy. An observation of care was conducted on 6/10/25 at 10:43 AM. Employee Identifier (EI) # 6, Pre-Op (Pre-Operative) RN ( Registered Nurse), without performing hand hygiene, weighed and admitted PI # 19 to the Pre-Op area, Bay # 20. EI # 7 (Pre-Op RN), without performing hand hygiene, donned gloves to obtain PI # 19's vital signs. The initial blood pressure cuff did not inflate correctly. The cuff was removed and cleaned with a Cavi-Wipe. While wearing the same pair of gloves used to clean the blood pressure cuff, a second cuff was applied to obtain PI # 19's blood pressure. The second cuff and cords were cleaned, the contaminated gloves were removed and hand hygiene was not performed. Without performing hand hygiene, EI # 7 gathered and opened supplies to start PI # 19's IV (Intravenous) catheter, including spiking the IV bag. EI # 6 and EI # 7, did not perform hand hygiene according to facility policy. An observation was conducted on 6/10/25 at 11:31 AM of an unsampled patient receiving a blood glucose check. EI # 9, Pre-Op RN, after obtaining the blood sugar, and wearing the same contaminated gloves, obtained a Cavi-Wipe, cleaned the glucometer and returned it to a counter in the Pre-Op area. EI # 9 removed the contaminated gloves and without performing hand hygiene, re-entered the unsampled patient's bay. EI # 9 did not perform hand hygiene according to facility policy. The observation of PI # 19 continued at 12:03 PM, when EI # 8, Anesthesiologist entered PI # 19's Bay, and without performing hand hygiene, performed a brief physical assessment. EI # 8 exited the patient's bay and did not perform hand hygiene. At 2:07 PM, EI # 10, CRNA (Certified Registered Nurse Anesthetist) and EI # 11, Circulating RN, entered PI # 19's patient bay and without performing hand hygiene, donned gloves to transport PI # 19 to the OR ( operating room). After surgery was completed, PI # 19 was transported to the PACU (Post Anesthesia Care Unit). EI # 13, PACU RN, without performing hand hygiene, donned gloves and cared for the patient. EI # 8, # 10, # 11, and # 13 did not perform hand hygiene according to the facility policy. An interview was conducted on 6/12/25 at 2:40 PM with EI # 1, Director of Nursing, who confirmed the staff did not perform hand hygiene according to facility policy.