| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 01C0001011 | (X3) Date Survey Completed 12/07/2023 |
| Name of Provider or Supplier Gadsden Surgery Center, Ltd | Street Address, City, State 418 South 5th Street, Gadsden, 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 on 12/5/23 to 12/7/23 at Gadsden Surgery Center. The facility was found to be in substantial compliance with the Emergency Preparedness Conditions for Coverage under 42 CFR 494.62. |
| Q0000 | A recertification survey was conducted at Gadsden Surgery Center on 12/5/23 to 12/7/23. An acceptable plan of correction is required for standard level deficiency 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 observations, review of policy and procedure, Manufacturer Guidelines for Use, and interviews, it was determined the facility failed to ensure anesthesia medications requiring refrigeration were dated when removed from refrigeration resulting in the risk of administering medication with decreased potency. This did affect three of four observations and had the potential to negatively affect all patients served by this facility. Findings include: Facility Policy: Storage - Temp Control of Medications Policy Number:12002.5 Date Reviewed: 3/20/22 Policy: Drugs shall be stored properly, maintaining proper temperature in compliance with manufacturer specifications, to maintain potency and stability of the product. Procedure: ...Long Term Refrigeration Drugs requiring refrigeration for long term storage, but stored at room temperature for short periods ( e.g. Insulin, Succinylcholine,...) shall be destroyed when the recommended room temperature expiration date has expired. Manufacturers Guidelines for Use (package insert) for Rocuronium Bromide 50 milligrams (mg) / (per) milliliters (ml): ...16. How Supplied/Storage and Handling Rocuronium Bromide injection should be stored in a refrigerator, two degrees to eight degrees Centigrade (C), 36-46 degrees Fahrenheit (F). DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25 degrees C / 77 degrees F), use Rocuronium Bromide within 60 days. Use opened Rocuronium Bromide injection within 30 days. Manufacturers Guidelines for Use (package insert) for Succinylcholine Chloride 20 mg /10 ml. ...16. How Supplied/Storage and Handling Refrigeration of undiluted Succinylcholine Chloride Injection, USP (United States Pharmacopeia) will assure full potency until expiration date. All units carry a date of expiration. Store in refrigerator two degrees to eight degrees C (36 degrees to 46 degrees F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. 1. An inspection of the anesthesia cart in OR (operating room) # 1 was conducted on 12/5/23 at 11:58 AM with Employee Identifier (EI) # 2, OR Manager. The following medications were observed in the drawer of the cart and available for patient use: One unopened vial of Rocuronium Bromide 50 mg/5 ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. One unopened vial of Succinylcholine Chloride 20 mg/ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. EI # 2 confirmed at the time of the observation, there was no date written on the vials to indicate when they had been removed from refrigerated storage or when they would expire. 2. An inspection of the anesthesia cart in OR # 2 was conducted on 12/5/23 at 12:09 PM with EI # 2. The following medications were observed in the drawer of the cart and available for patient use. One unopened vial of Rocuronium Bromide 50 mg/ 5 ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. One unopened vial of Succinylcholine Chloride 20 mg/ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. EI # 2 confirmed at the time of the observation, there was no date written on the vials to indicate when they had been removed from refrigerated storage or when they would expire. 3. An inspection of the anesthesia cart in OR # 3 was conducted on 12/5/23 at 12:20 PM with EI # 2 and EI # 9, CRNA (Certified Registered Nurse Anesthetist). The following medications were observed in the drawer of the cart and available for patient use. Two unopened vials of Rocuronium Bromide 50 mg/ 5 ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. One unopened vial of Succinylcholine Chloride 20 mg/ml. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. EI # 2 and EI # 9 confirmed at the time of the observation, there was no date written on the vials to indicate when they had been removed from refrigerated storage or when they would expire. |
| Q0220 | NOTICE - POSTING CFR(s): 416.50 ... The ASC must also post the written notice of patient rights in a place or places within the ASC likely to be noticed by patients waiting for treatment or by the patient's representative or surrogate, if applicable. This STANDARD is not met as evidenced by: Based on the posted Patient Rights and Responsibilities framed document, facility policy and staff interview, it was determined the facility failed to include the 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. Findings include: Facility Policy: Patient's Rights and Responsibilities Revision Date: 7/2023 Centers for Medicare and Medicaid Services (CMS) The patient and the patient's representative or surrogate has the right to: ...Voice grievances regarding treatment or care that is (or fails to be) provided. Complaint/grievance process: ...If you are not satisfied with the response of Gadsden Surgery Center you may contact the State of Alabama via: Mail: P.O. Box 5624, Montgomery AL 36103-5624. Phone (334) 242-5000. Email or Web Address: www.mediciad.alabama.gov During the tour of the facility on 12/5/23 at approximately 9:45 AM an observation of the posted Patient Rights and Responsibilities framed document located at the patient check in station revealed the State Agency Hotline number 1 (800) 356-9596 was not included as part of the contact information for grievances and complaints. An interview was conducted on 12/6/23 at approximately 12:04 PM with Employee Identifier (EI) # 1, Practice Administrator, who confirmed the State Agency Hotline number was not included in the posted Patient Rights and Responsibilities framed document. |
| 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 review of the written notice of patient rights, facility policy and staff interview, it was determined the facility failed to include the State Agency Hotline phone number 1 (800) 356-9596 to which patients may report complaints or grievances. This deficient practice had the potential to negatively affect all patients served by this facility. Findings include: Facility Policy: Patient's Rights and Responsibilities Revision Date: 7/2023 Centers for Medicare and Medicaid Services (CMS) The patient and the patient's representative or surrogate has the right to: ...Voice grievances regarding treatment or care that is (or fails to be) provided. Complaint/grievance process: ...If you are not satisfied with the response of Gadsden Surgery Center you may contact the State of Alabama via: Mail: P.O. Box 5624, Montgomery AL 36103-5624. Phone (334) 242-5000. Email or Web Address: www.mediciad.alabama.gov A review of the written notice of Patients Rights documents revealed the State Agency Hotline phone number 1 (800) 356-9596, for patients to report complaints was not included in the information provided to the patient. An interview was conducted on 12/6/23 at approximately 12:04 PM with Employee Identifier (EI) # 1, Practice Administrator, who confirmed the staff failed to provide the State Agency Hotline number to the patients. |
| 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 policies and procedures and staff interviews, it was determined the facility failed to ensure the staff: 1. Performed hand hygiene prior to donning gloves and after removing gloves. 2. Wore gloves per facility policy and procedure. Findings Include: Facility Policy: Hand Hygiene Policy Number: 11011 Reviewed: 1/2023 ...All personnel will wash hands: When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or body fluids. Before having direct contact with patients. ...After coming in contact with the patient's intact skin... After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. After removing gloves... 2. An observation of patient care was conducted on 12/6/23 at 12:04 PM to follow PI # 20 through the Pre-Op, Surgery, Recovery and Discharge process for a Right Carpal Tunnel Release and Right Ulnar Nerve Decompression. In the Pre-Op area, EI # 6, RN (Registered Nurse), removed gloves prior to starting an IV (Intravenous) line and without performing hand hygiene (HH), donned a pair of gloves and started the patient's IV. In the PACU (Post Anesthesia Care Unit), EI # 8, RN, without performing HH, donned gloves to inject Demerol. Without performing HH, EI # 8 donned gloves prior to injecting Labetalol. With gloved hand, EI # 8 threw the patients coffee cup away, removed gloves and did not perform HH. Without performing HH, EI # 8, donned gloves to remove the pulse oximeter from the patient's finger, removed gloves and did not perform HH. After discontinuing the patient's IV, EI # 8, removed gloves and without performing HH, donned gloves to transport the patient to the Discharge area. An interview was conducted on 12/07/23 at 12:05 PM with EI # 1, Practice Administrator, who confirmed staff failed to perform HH prior to donning gloves and after removing gloves per facility policy. 1. On 12/6/23 at 11:55 AM an observation of the staff cleaning an endoscope was conducted in procedure room # 1. Employee Identifier (EI) # 10, Endoscopy Technician, flushed the ports with solution, removed gloves then donned new gloves. EI # 10 failed to perform hand hygiene after removing gloves. EI # 10 then cleaned the Neptune suction machine with disinfecting wipes, disposed of the suction tubing, removed gloves then donned new gloves. EI # 10 failed to perform hand hygiene after removing gloves. EI # 10 then transported the endoscope to the endoscope cleaning room. EI # 11, Surgical Technician, cleaned the outer surface of the scope, cleaned the ports, flushed the lines, and placed the endoscope in the Steri-Cycle machine. EI # 11 then removed gloves and donned new gloves. EI # 11 failed to perform hand hygiene after removing gloves. EI # 11 then wiped the endoscope transport bin with disinfecting wipes, removed gloves and donned new gloves. EI # 11 failed to perform hand hygiene after removing gloves. An interview was conducted on 12/7/23 at 12:00 PM with EI # 1, Practice Administrator, who confirmed the staff failed to perform hand hygiene after glove removal per facility policy. |