Statement of Deficiencies

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)
E0000	An onsite recertification survey was conducted from 1/2/24 to 1/4/24. Surgery Center South was found to be in substantial compliance with the Centers for Medicare and Medicaid Services requirements for Emergency Preparedness.
Q0000	An onsite recertification survey was conducted on 1/2/24 to 1/4/24 at Surgery Center South. Condition level deficiencies and related standards were cited for 416.44 Environment.
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 facility tour with hospital staff by the Life Safety Surveyor and staff interviews, it was determined the facility was not constructed, arranged and maintained to ensure patient safety. This had the potential to negatively affect all patients served by the facility. Findings include: Refer to Life Safety Code violations K 0131, K 0321, K 0325, K 0345, K 0353, K 0372, K 0781,and K 0918 for findings.
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 review of the facility policies and procedures, medical records (MRs), Centers for Disease Control and Prevention (CDC) Safe Practices for Medical Injections, CDC Injection Safety, observations, and interviews with the staff it was determined the facility failed to ensure: 1. Expired and/or beyond use medication and supplies were not available for patient use. 2. Multi-dose vials used for more than one patient in the operating room (OR) did not enter an immediate patient care area. 3. Single dose vials were not used for multiple patients. 4. The staff cleaned the rubber diaphragm of the medication prior to drawing up medications. 5. Medication administration was per the physician's order. 6. Medications were administered only upon the order of a physician. This affected Patient Identifier (PI) # 19, PI # 20 and PI # 11, three of twenty MRs reviewed, had the potential to negatively affect all patients served by the facility. Findings include: Facility Policy: Expired Medication/Controlled Drug Disposal Date: Not documented Policy: All medications will be monitored monthly for expiration. Expired medications will be immediately removed and disposed of according to policy. Procedure: ...All areas of the center will monitor drug inventory on a monthly basis for expiration dates. Facility Policy: Expired Solutions and Supplies Date: Not documented ...Procedure: All areas of the center will be checked monthly for expired products... Expired products will be disposed of according to manufacturer's guidelines. Facility Policy: Administration of Medication Date: Not documented Policy: Medication will be administered according to established policies and standards of practice. Procedure: ...All medications require written or pre-printed orders prior to administration. All medications...administered will be recorded in the patient's medical record with date, time, and signature of the person giving the medication. Facility Policy: Injection Practices Date: Not documented Policy: All members of the healthcare team will comply with current CDC recommendations for safe injection practices. ...6. Do not administer medications from single dose vials or ampules to multiple patients or combine leftover contents for later use. ...8. Do not keep multi dose vials (MDV) in the immediate patient treatment area... Facility Policy: MDV Date: Not documented Policy: MDVs will be discarded...28 days after opening... Procedure: ...Medication with a limited shelf life after opening will be dated and initialed. CDC Safe Practices for Medical Injections Review Date: 6/20/19 Parenteral medications should be accessed in an aseptic manner. ...the rubber septum should be disinfected with alcohol prior to piercing it. CDC Injection Safety Review Date: 6/20/19 ...MDVs should be dedicated to a single patient whenever possible. If MDVs must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area (e.g. nurses station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a MDV enter an immediate patient treatment area, it should be dedicated for single-patient use only... Examples of immediate patient treatment areas include operating and procedure rooms... 1. A tour of the eye pre- op (operative) area was conducted on 1/2/24 at 10:16 AM with Employee Identifier (EI) # 1, Administrator. During the tour the following medications were observed and available for patient use: a. Six opened bottles of Systane 10 ml (milliliters) ophthalmic (Eye) gel drops, three without an opened date, two with a beyond use date labeled as 10/24/23, and one with a beyond use date labeled as 11/13/23. b. Nine opened Tropicamide - Phenylephrine 0.5 % (percent) 5 ml ophthalmic solution bottles without an opened date. c. An opened Cyclopentolate Hydrochloride 1 % 2 ml ophthalmic solution bottle with a labeled beyond use date of 11/15/23. d. Five opened Tetracaine Hydrochloride 0.5 % 5 ml ophthalmic solution bottles with three without an opened date, one labeled beyond use date of 11/14/23 and one 11/15/23. e. Three opened Dicolofenac Sodium 0.1 % 5 ml ophthalmic solution bottles, one without an opened date, one with a labeled beyond use date of 11/15/23, and one with a labeled beyond use date of 11/16/23. f. Two opened Moxifloxacin 5 ml ophthalmic solution bottles, one with a labeled beyond use date of 11/16/23 and one with a labeled beyond use date of 11/14/23. g. An opened Lidocaine Hydrochloride 300 mg (milligram)/ 30 ml single dose vial was available for patient use. h. An opened Polocaine 400 mg/20ml single dose vial was available for patient use. i. An opened Children's Tylenol 120 ml bottle with a labeled beyond use date of 11/23. j. An opened Acetaminophen 325 mg bottle without an opened date. k. An opened Novolin R (Regular) insulin MDV without an opened date. l. An opened bottle of Phenyleprine Hydrocholride Ophthalmic solution 2.5% with a labeled beyond use date of 11/16/23. During the tour, EI # 1 confirmed the facility failed to ensure expired and beyond use date medications were removed, opened medications were labeled, and single dose vials were not stored for patient use. 2. A tour of the eye PACU (Post Anesthesia Care Unit) area was conducted on 1/2/24 at 11:20 AM with EI # 1. During the tour the following medications and supplies were observed and available for patient use: a. Two opened Miostat 0.01% 1.5 ml vials without an opened date. b. An opened Bacitracin 50,000 Unit solution bottle with a labeled beyond use date of 5/22/23. c. Four opened Miochol E (eye) 20 mg/2ml ophthalmic solution bottles with labeled beyond use date of 9/23/23. d. Nineteen 0.9 % Sodium Chloride 30 ml vials with an expiration date of 11/1/23. e. An opened Lugol's Strong Iodine solution 8 ml bottle with a labeled beyond use date of 4/23/23. f. An opened Ceftazidine 1 gm (gram) bottle with a labeled beyond use date of 11/23/23. g. Three Lidocaine HCL 200 mg/5 ml vials with an expiration date of 11/1/23. h. Two opened Solu-Cortef 100 mg 2ml single dose vials were available for patient use. i. An opened Children's Tylenol 120 ml bottle with a labeled beyond use date of 11/23. j. Two 25 Gauge (G) 1 1/2 needle syringe with an expiration date of 10/31/22. During the tour, EI # 1 confirmed the facility failed to ensure expired and beyond use date medications were removed, opened medications were labeled, and single dose vials were not stored for later patient use. 3. A tour of the west pre- op area was conducted on 1/2/24 at 12:44 PM with EI # 10, Registered Nurse (RN) charge nurse. During the tour the following supplies were observed and available for patient use: a. An Intravenous (IV) administration set with an expiration date of 11/26/23. b. 73 syringe tip caps with an expiration date of 2/28/23. During the tour, EI # 10 confirmed the facility failed to ensure expired supplies were removed. 4. A tour of the west OR suites was conducted on 1/2/24 at 4:12 PM with EI # 1. During the tour the following medications were observed and available for patient use: a. A 0.9 % Sodium Chloride 100 ml vial with an expiration date of 9/23. b. A Labetalol HCL 100 mg/20 ml vial with an expiration date of 12/1/23. c. A Solu-Cortef 100 mg vial with an expiration date of 11/23. During the tour, EI # 1 confirmed the facility failed to ensure expired medications were removed. 5. A tour of the eye OR suites was conducted on 1/2/24 at 5:00 PM with EI # 1. During the tour the following supplies were observed and available for patient use: a. A gray top laboratory (lab) collection tube with an expiration date of 8/31/23. b. A purple top lab collection tube with an expiration date of 11/30/23. c. A navy top lab collection tube with an expiration date of 9/30/23. d. A blue top lab collection tube with an expiration date of 11/30/23. During the tour, EI # 1 confirmed the facility failed to ensure expired medications were removed. 6. An observation was conducted on 1/3/24 at 9:08 AM of a Right Eye Cataract Extraction with Intraocular Lens on PI # 19. During the procedure, EI # 5, Certified Registered Nurse Anesthetist (CRNA), withdrew and administered 2 mg of Versed from a single dose vial without cleansing the access septum of the vial with alcohol prior to puncture with the needle. An interview was conducted on 1/4/24 at 4:15 PM with EI # 1 who confirmed EI # 5 failed to follow the facility policy for safe injection practices. 7. An observation was conducted on 1/3/24 at 1:46 PM of a Right Eye Cataract Extraction with Intraocular Lens on PI # 20. EI # 6, RN, obtained a MDV of Dexamethasone Sodium Phosphate 120 mg/30 ml and Triamcinolone Acetonide Injectable Suspension 400 mg/ 10 ml from the supply cabinet of OR 2, wiped each MDV with alcohol, and presented each MDV individually to EI # 11, Scrub Technician, who withdrew the medications from each MDV individually and placed the filled syringes on the sterile OR field for use during the procedure. EI # 6 then replaced both MDVs in the supply cabinet of the OR for later patient use. Review of the MR Physician orders dated 1/4/24 revealed an order for Imprimis 1 drop to the right eye twice with each drop five minutes apart. Review of the Pre-Operative note dated 1/3/24 revealed the nurse administered Imprimis 2 drops to the right eye at 12:35 PM. There was no documentation the drops were five minutes apart per the physician's order. An interview was conducted on 1/3/24 at 2:40 PM with EI # 6 who confirmed the Dexamethasone Sodium Phosphate 120 mg/30 ml and Triamcinolone Acetonide Injectable Suspension 400 mg/ 10 ml MDVs were placed in the OR supply cabinet prior to the start of patient procedures and have been used for two patient procedures on 1/3/24. EI # 6 verbalized the MDVs are removed at the end of the day and placed in medication refrigerator for use in the OR's for up to 30 days on multiple patients. A second interview was conducted on 1/4/24 at 4:31 PM with EI # 2, Operating Room Supervisor, who confirmed there was no documentation the Imprimis drops were five minutes apart per the physician's order. 8. PI # 11 was admitted to the facility on 11/15/23 with diagnoses of Right Upper Eyelid Basal Cell Carcinoma Status Post Mohs (Micrographically Oriented Histographic Surgery) Surgery and Right Upper Eyelid Defect Measuring Six Centimeters. Review of the Physician's Orders signed by the physician on 11/13/23 revealed orders for Ancef 1 gram IV one hour before surgery and Zofran 4 mg IV 30 minutes before surgery for the planned Right Upper eyelid Mohs reconstruction via Adjacent Tissue Transfer. Review of the Anesthesia Record dated 11/15/23 revealed the CRNA (Certified Registered Nurse Anesthetist) administered Ancef 1 gram at 3:12 PM and the surgical procedure started at 3:27 PM, 15 minutes after the Ancef was administered. Further review revealed the CRNA administered Zofran 4 mg. There was no documentation of the time Zofran was administered. The CRNA failed to administer the Ancef one hour prior to the surgical procedure per the physician's order and document the time Zofran was administered. An interview was conducted on 1/4/24 at 4:33 PM with EI # 2, who confirmed the Ancef was not administered one hour prior to the surgical procedure per the physician's order and there was no documentation of the time Zofran was administered. 9. PI # 19 was admitted to the facility on 1/3/24 with a diagnosis of Right Eye Cataract with planned surgical procedure of Right Eye Phacoemulsification of Cataract with Intraocular Lens Insertion. . Review of the Physician orders dated 12/19/23 revealed an order for Imprimis 1 drop to the right eye. Review of the Pre-Operative note dated 1/3/24 revealed the nurse administered Imprimis 2 drops to the right eye at 8:57 AM. An interview was conducted on 1/4/24 at 4:31 PM with EI # 2 who confirmed there was no documentation the physician ordered 2 drops to be administered to the right eye.
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.