Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 01C0001010	(X3) Date Survey Completed 09/19/2019
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	A recertification survey was conducted on 9/19/19 at Surgery Center South and standard level deficiencies were cited for the Emergency Preparedness Program.
E0024	Policies/Procedures-Volunteers and Staffing CFR(s): 416.54(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. [For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. [For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on review of the Emergency Preparedness (EP) Program manual and interviews with the staff, it was determined the facility failed to ensure a volunteer policy was initiated for the EP Program which complied with State and Federal requirements. Findings include: Review of the EP Program conducted on 9/18/19 revealed no documentation of a policy for the use of volunteers during an emergency. An interview was conducted on 9/18/19 at 12:30 PM with EI # 2, Administrator, who confirmed the above mentioned findings.
Q0000	A recertification survey was conducted on 9/19/19 at Surgery Center South and the following conditional level deficiency for Life Safety Code was cited at 416.44 and other standard level deficiencies.
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 South 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 served. Findings: Refer to Life Safety Code violations on additional 2567.
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 facility policies and procedures, observations and staff interviews, it was determined the facility failed to ensure staff labeled all medications after opening as directed per facility policy and all medications and supplies were safe for patient use and not expired. This had the potential to negatively affect all patient served by the facility. Findings include: Policy: Expired Medications/Controlled Drug Disposal Policy Number: None Date: None Policy: All medications will be monitored for expiration. Expired medications will be immediately removed and disposed of according to policy. Purpose: To maintain an inventory of active pharmaceuticals Procedure: ...All areas of the Center will monitor drug inventory on a monthly basis for expiration dates. Policy: Expired Solutions and Supplies Policy Number: None Date: None Policy: Surgery Center South will have a policy for the monitoring and disposal of expired products, including all supplies, solutions, and any other items with expiration dates. Purpose: To ensure all expired items are removed and disposed of properly Procedure: All areas of the Center (including crash carts) will be checked monthly for expired products... Policy: Emergency Code Cart Policy Number: None Date: None Policy: Emergency equipment is readily accessible at all times. Purpose: To ensure the Center's ability to respond immediately to life threatening situations. Procedure: A binder will be maintained on the Code Cart and will include: ...Monthly code cart inventory to include: ...Emergency Drug (to include expiration dates) and supply list... ...Emergency drugs will be restocked as needed and checked for expiration dates on a monthly basis... Policy: Multi-Dose Vials Policy Number: None Date: None Policy: Multi-use vials will be discarded when empty, 28 days after opening, at the manufacture's expiration date, if there is obvious or suspected contamination, or at the recommendation of the manufacture. Procedure: ...Medication with a limited shelf life after opening will be dated and initialed. Policy: Malignant Hyperthermia Cart Policy Number: None Date: None Malignant Hyperthermia cart shall be restocked and checked at least monthly and after every use. Monthly checks shall include checking of expiration dates. If there is an item nearing expiration, the item is replaced... 1. A tour of the facility was conducted on 9/17/19 at 9:10 AM with Employee Identifier (EI) # 1, Director of Nursing (DON). During the tour of the facility the recovery area of the eye surgery side was observed which included 10 bays. Observations in the eye recovery area revealed in bay # 10 the following: 1 - opened bottle of Peroxide without an open date and the lid was only partially on the bottle. 1- open 500 ml (milliter) bottle of Sterile Water without an open date on the bottle. 39- Percocet were in the narcotic lock up box and had the expiration date of 7/19. An interview was conducted on 9/17/19 at 9:35 AM with EI # 1 who confirmed the above mentioned findings. 2. An observation was conducted on 9/17/19 at 9:45 AM to observe the pre (before)/post (after) op (operation) sections of the GI (Gastrointestinal) area. During the tour, the medication cupboard was checked and the following medication was found to be expired: Midazolam HCL (Hydrochloride) 2 mg (milligram) per 1 ml in a 110 ml bottle with an expiration date of August 19, 2019. An interview was conducted on 9/17/19 at 10:00 AM with EI # 1 who confirmed the above mentioned findings. 3. An observation was conducted on 9/17/19 at 10:05 AM of all vacant OR (operating room) suites. Observation of OR suite # 11 revealed near the anesthesia cart a 250 ml bottle of Servoflurane inhalation anesthetic. The bottle contained approximately 75 ml of solution and no open date label was on the bottle. An interview was conducted on 9/17/19 at 10:30 AM with EI # 1 who confirmed the above mentioned findings. 4. An observation was conducted on 9/17/19 at 11:00 AM in the hallway of the OR suites # 1- 6 to observe the crash cart. Observation of the crash cart revealed the following medication and supplies were expired: 1- 10 ml bottle of Epinephrine expired 8/19 4- 0.9% Normal Saline (NS) flushes expired 7/31/19 1- 0.9% NS flush expired 8/31/19 1- Adult CO2 (Carbon dioxide detector) expired 8/6/19 2- 500 ml bags of Lipids expired 8/19 An interview was conducted on 9/17/19 at 11:20 AM with EI # 1 who confirmed the above mentioned findings. 5. An observation was conducted on 9/17/19 at 11:25 AM to observe the Hyperthermia cart. Observation of the Hyperthermia cart revealed the following medications and supplies were expired: 1- esophageal stethoscope with temperature probe expired 8/19 5- 60 ml syringes expired 5/14 5- mini spike dispensing pins expired 7/18 2- red top blood vials expired 5/18 1 blue top blood vial expired 6/30/18 1- green top blood vial expired 11/30/18 1- purple top blood vial expired 6/30/18 1- orange top blood vial expired 5/31/18 4- tegaderm expired 2018 4- Jelco 18 gage needles expired 6/19. An interview was conducted on 9/17/19 at 11:50 AM with EI # 1 who confirmed the above mentioned findings. 6. An observation was conducted on 9/17/19 at 11:50 AM to observe the difficult airway cart. Observation of the difficult airway cart revealed the following supplies were expired: 1- oral airway 6.5 mm (millimeters) expired 7/19 1- laryngeal mask airway expired 8/19 1- laryngeal mask airway expired 4/19 1- laryngeal mask airway expired 5/19 An interview was conducted on 9/17/19 at 12:10 PM with EI # 1 who confirmed the above mentioned findings.
Q0221	NOTICE OF RIGHTS CFR(s): 416.50(a) An ASC must, prior to the start of the surgical procedure, provide the patient, or 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 medical records (MR) and interviews with the staff it was determined the facility failed to have a new Patient Acknowledgement Form signed for each new surgery performed at the Center on each patient. This affected 3 of 20 MR's reviewed and did affect Patient Identifier (PI) # 2, PI # 3 and PI # 7 and had the potential to negatively affect all patients served by the facility. Findings include: 1. PI # 2 was admitted to the surgery center on 1/7/19 for a EGD (esophagogastroduodenoscopy) with a Colonoscopy. Review of the Patient Acknowledgement Form revealed a date of November 27, 2017. Further review revealed no documentation an Acknowledgement Form was signed for his/her surgery dated 1/7/19. An interview was conducted on 9/19/19 at 4:20 PM with Employee Identifier (EI) # 2, Administrator, who confirmed the above mentioned findings. 2. PI # 3 was admitted to the surgery center on 6/11/19 for a Colonoscopy. Review of the Patient Acknowledgement Form revealed a date of 11/2/15. Further review revealed no documentation an Acknowledgement Form was signed for his/her surgery dated 6/11/19. An interview was conducted on 9/19/19 at 4:20 PM with EI # 2 who confirmed the above mentioned findings. 3. PI # 7 was admitted to the surgery center on 6/20/19 for a Cataract Removal. Review of the Patient Acknowledgement Form revealed a date of 1/3/17. Further review revealed no documentation an Acknowledgement Form was signed for his/her surgery dated 6/20/19. An interview was conducted on 9/19/19 at 4:20 PM with EI # 2 who confirmed the above mentioned findings.