Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 01C0001000	(X3) Date Survey Completed 11/16/2023
Name of Provider or Supplier Montgomery Surgical Center Llc	Street Address, City, State 470 Taylor Road, Montgomery, 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	Based on a recertification survey conducted on 11/14/23 to 11/16/23, Montgomery Surgical Center LLC, was found to be in substantial compliance with the Centers of Medicare/Medicaid Services requirements for Emergency Preparedness.
Q0000	A recertification survey was conducted at Montgomery Surgery Center, LLC on 11/14/23 to 11/16/23. An acceptable plan of correction is required for standard level deficient findings.
Q0162	FORM AND CONTENT OF RECORD CFR(s): 416.47(b) The ASC must maintain a medical record for each patient. Every record must be accurate, legible, and promptly completed. Medical records must include at least the following: (1) Patient identification. (2) Significant medical history and results of physical examination (as applicable); (3) Pre-operative diagnostic studies (entered before surgery), if performed. (4) Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those exempted by the governing body. (5) Any allergies and abnormal drug reactions. (6) Entries related to anesthesia administration. (7) Documentation of properly executed informed patient consent. (8) Discharge diagnosis. This STANDARD is not met as evidenced by: Based on review of medical records (MR), facility policies and procedures, and interviews with facility staff, it was determined the facility failed to ensure: 1. Physicians performing the surgery documented the date and time Routine Standing Orders (RSO's), and Physician's Order Sheet (POS) were signed in twelve of twenty records reviewed. This did affect Patient Identifier (PI) # 11, PI # 17, PI # 19, PI # 8, PI # 4, PI # 12, PI # 20, PI # 2, PI # 18, PI # 16, PI # 13, and PI # 15. 2. The physician signed, dated, and timed the Pre-Operative (Pre-Op) Ophthalmic Medications and Physician's Orders in one of one record reviewed for Cataract surgery. This did affect PI # 12. 3. History and Physical (H & P) Examinations were legible. This affected five of twenty records reviewed including PI # 11, PI # 17, PI # 19, PI # 16, and PI # 13. These deficient practices increase the potential for error and affect all patients served by this facility. Findings include: Facility Policy: Admission to MSC (Montgomery Surgery Center) Review Date: 1/23 Policy: All patients are identified... and medical record preparation is completed during the admission process. Procedure: ...2. ...M. D. (Medical Doctor) standing orders are obtained and signed off by the Pre-Operative registered nurse... Facility Policy: Record Review Date: 1/23 ...Procedure: ...9. All M.D. orders are to be signed off, dated, and timed. 7. PI # 20 was admitted to the facility on 8/17/23 for a Laparoscopy. Review of the POS revealed a photocopied physician signature and no date and time the orders were signed by the physician. An interview was conducted on 11/16/23 at 9:24 AM with EI # 2 who stated the physician does not have RSO, the office staff fax the orders to the surgery center. EI # 2 confirmed the POS did not include the date and time the physician signed the POS. 8. PI # 2 was admitted to the facility on 9/11/23 for a Right Partial Mastectomy and Right Sentinel Lymph Node Biopsy. Review of the POS revealed a photocopied physician signature and no date and time the orders were signed by the physician. An interview was conducted on 11/16/23 at 9:19 AM with EI # 2 who confirmed the POS documentation failed to include the date and time the physician signed the orders. 9. PI # 18 was admitted to the facility on 7/7/23 for a Diagnostic Laparoscopy. Review of the POS revealed a photocopied physician signature and no date and time the orders were signed by the physician. An interview was conducted on 11/16/23 at 9:18 AM with EI # 2 who stated the physician does not have RSO, and orders are faxed to the surgery center. EI # 2 confirmed the POS documentation did not include the date and time the physician signed the POS. 10. PI # 16 was admitted to the facility on 4/28/23 for a Colonoscopy, Possible Biopsy, Possible Polypectomy. Review of the RSO's revealed a "pre-printed" (photocopied) physician signature. There was no date and time the orders were signed by the physician. Review of the 4/28/23 H & P Examination documented by the physician revealed the documentation was not legible. An interview was conducted on 11/16/23 at 9:20 AM with EI # 2 who confirmed the RSO's were already pre-printed (photocopied) with the physician signature and the physician did not sign and date the orders. EI # 2 confirmed the History and Physical Examination documentation was not legible. 11. PI # 13 was admitted to the facility on 9/19/23 for an Esophagogastroduodenoscopy, Possible Biopsy, Possible Dilatation. Review of the RSO revealed a "pre-printed" (photocopied) physician signature. There was no date or time the orders were signed by the physician. Review of the 9/19/23 H & P Examination document completed by the physician revealed the chief complaint was epigastric discomfort, gastroesophageal reflux. The past medical history and physical examination documentation was not legible. An interview was conducted on 11/16/23 at 9:20 AM with EI # 2 who confirmed the RSO was already pre-printed (photocopied) with the physician signature and the physician did not sign and date the orders. EI # 2 confirmed the History and Physical Examination documentation was not legible. 12. PI # 15 was admitted to the facility on 2/15/23 for Right Shoulder Video Arthroscopy, Subacromial Decompression, Distal Clavicle Resection and Rotator Cuff Repair. Record review revealed a POS faxed to the facility with instructions for the "operative permit to read", anesthesia type "choice", and a "pre-printed" (photocopied) physician signature. There was no date or time the POS was signed by the physician. Further record review revealed a RSO for the specified surgical group with pre-printed (photocopied) signatures of nine physicians. The ROS had a total of seven individual orders listed per the following: a. Order number one-surgical site clip/prepare per physician preference. b. Order number two-pre-operative antibiotics for eight physicians and NO antibiotics for one named physician during specific procedures. c. Order number five- antibiotic orders for two named physicians, and orders for use of compression device for one named physician. d. Order number six-routine prophylaxis orders for one named physician, specific for dialysis patients, or patient hospitalization within the last year. e. order number seven-orders for compression device use for specific procedures for three named physicians. There was no date and time the physician performing the surgery signed the orders. An interview was conducted on 11/16/23 at 9:15 AM with EI # 2 who confirmed the RSO's were already pre-printed (photocopied) with the physician signature. EI # 2 confirmed the physician performing the surgery did not sign and date the RSO. The ROS described above increased the potential for prep-operative errors. 5. PI # 4 was admitted to the facility on 10/04/23 for Left Knee Manipulation Under Anesthesia. Record review revealed a POS faxed to the facility with instructions for the "operative permit to read", anesthesia type "choice", and a "pre-printed" (photocopied) physician signature. There was no date or time the POS was signed by the physician. Further record review revealed a RSO for the specified surgical group with pre-printed (photocopied) signatures of nine physicians. The ROS had a total of seven individual orders listed per the following: a. Order number one-surgical site clip/prepare per physician preference. b. Order number two-pre-operative antibiotics for eight physicians, and NO antibiotics for one named physician during certain named procedures. c. Order number five- antibiotic orders for two physicians, and orders for use of compression device for one named physician. d. Order number six-routine prophylaxis orders for one named physician, specific for dialysis patients, or patient hospitalization within the last year. e. order number seven-orders for compression device use for specific procedures for three named physicians. An interview was conducted on 11/16/23 at 9:08 AM with EI # 2 who confirmed the RSO's were already pre-printed (photocopied) with the physician signature. EI # 2 confirmed the physician performing the surgery did not sign and date the RSO. The RSO described above, pre-signed by nine physicians and not signed and dated when implemented by the physician performing the surgery, increase the potential for pre-operative errors. 6. PI # 12 was admitted to the facility on 11/14/23 for Cataract Extraction with Intraocular Implant Right Eye. A review of the Pre-Op Ophthalmic Medications orders revealed no documentation the physician signed, dated, and timed the orders. Further review of the MR revealed a Physician's Order with no documentation of the date and time the physician signed the order. An interview was conducted on 11/16/23 at 8:33 AM EI # 1 who confirmed there was no documentation the physician signed dated and timed the orders. 4. PI # 8 was admitted to the facility on 10/10/23 for Septoplasty, Submucosal Resection Turbinoplasty and Anterior Ethmoidectomy. Review of the RSO's revealed a "pre-printed" (photocopied) physician signature. There was no date or time the orders were signed by the physician. An interview was conducted on 11/16/23 at 8:43 AM with EI # 2, who confirmed the RSO's were already pre-printed (photocopied) with the physician signature and the physician did not sign and date the orders. 1. PI # 11 was admitted to the facility on 9/8/23 for a Colonoscopy, Possible Biopsy, Possible Polypectomy. Review of the RSO's revealed a "pre-printed" (photocopied) physician signature. There was no date or time the orders were signed by the physician. Review of the 9/8/23 H & P Examination document completed by the physician revealed the chief complaint was screening evaluation. The past medical history and physical examination documentation was not legible. An interview was conducted on 11/16/23 at 8:57 AM with Employee Identifier (EI) # 2, Peri-anesthesia Nurse Manager (PNM), who confirmed the RSO's were already pre-printed (photocopied) with the physician signature and the physician did not sign and date the orders. EI # 2 confirmed the History and Physical Examination documentation was not legible. 2. PI # 17 was admitted to the facility on 6/23/23 for a Colonoscopy, Possible Biopsy, Possible Polypectomy. Review of the RSO revealed a "pre-printed" (photocopied) physician signature. There was no date or time the orders were signed by the physician. Review of the 6/23/23 H & P Examination document completed by the physician revealed the chief complaint was bleeding from rectum. The past medical history and physical examination documentation was not legible. An interview was conducted on 11/16/23 at 8:56 AM with EI # 2 who confirmed the RSO's were already pre-printed (photocopied) with the physician signature and the physician did not sign and date the orders. EI # 2 confirmed the History and Physical Examination documentation was not legible. 3. PI # 19 was admitted to the facility on 8/7/23 for a Colonoscopy, Possible Biopsy, Possible Polypectomy. Review of the RSO revealed a "pre-printed" (photocopied) physician signature. There was no date or time the orders were signed by the physician. Review of the 8/7/23 H & P Examination document completed by the physician revealed the chief complaint was Anemia. The past medical history and physical examination documentation was not legible. An interview was conducted on 11/16/23 at 8:50 AM with EI # 2 who confirmed the RSO's were already pre-printed (photocopied) with the physician signature and the physician did not sign and date the orders. EI # 2 confirmed the History and Physical Examination documentation was not legible.
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: 1. Medications were stored in a locked and secure area resulting in the risk of medication misuse. 2. Anesthesia medications requiring refrigeration were dated when removed from refrigeration resulting in the risk of administering medication with decreased potency. This did affect four of four observations and had the potential to negatively affect all patients served by this facility. Findings include: Facility Policy: Safe Injection, Infusion, and Medication Vial Practices Policy Number: None Date Reviewed: 1/23 Policy: Safe injection, infusion and medication vial practices shall be followed and adherence monitored. Procedure: A. Aseptic Technique ...4. Staff store, access, and prepare medications and supplies in a clean area on a clean surface. ...F. Medication Vials 1. Always follow manufacturer's Instructions for storage and use Manufacturers Guidelines for Use (package insert) for Rocuronium Bromide 50 milligrams (mg) / (per) milliliters (ml): Rocuronium Bromide 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 within 30 days. Manufacturers Guidelines for Use (package insert) for Succinylcholine Chloride 20 mg /10 ml. Refrigeration of undiluted Succinylcholine Chloride Injection, USP (United States Pharmacopeia) will assure full potency until expiration date. Store refrigerated 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. 2. An inspection of the anesthesia cart located in OR 8 was conducted on 11/14/23 at 2:40 PM with EI # 5, CRNA (Certified Registered Nurse Anesthetist). The following refrigerated medications were observed in the top drawer of the cart and available for patient use: Five unopened vials of Rocuronium Bromide 50 mg/ 5ml. 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 # 5 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 located in OR 6 was conducted on 11/14/23 at 3:00 PM with EI # 5. The following refrigerated medications were observed in the top drawer of the anesthesia cart and available for patient use. 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. Five unopened vials of Rocuronium Bromide 50 mg/5 ml. There was no date written on the vial to indicate when it had to been removed from refrigerated storage or when it would expire. EI # 5 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. 4. An inspection of the anesthesia cart located in OR 4 was conducted on 11/14/23 at 3:38 PM. with EI # 5. Eleven unopened vials of Succinylcholine Chloride 20 mg/ml were observed in the top drawer of the anesthesia cart and available for patient use. There was no date written on the vial to indicate when it had been removed from refrigerated storage or when it would expire. EI # 5 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. 1. A tour was conducted of the Pre- Op (Operative) area on 11/14/23 at 9:43 AM. The following medications were not stored in a secured and locked area: Top of anesthesia block cart located outside of the medication room a. Two unopened vials of Ropivacaine Hydrochloride Injection 0.5 % 20 ml, 100 mg /20 ml single dose vials and three unopened Ropivacaine Hydrochloride Injection 0.5 % 30 ml, 150mg/30ml single dose vials. Nurses station countertop located in baskets a. 13 vials of Cefazolin 1 gm (gram) with IV (intravenous) bags of Dextrose 50 ml, for IV injection use only. b. 22 vials of Cefazolin 1 gm per vial for injection. An interview was conducted on 11/14/23 at 10:06 AM with Employee Identifier (EI) # 2, Peri-anesthesia Nurse Manager (PNM), who verified the staff failed to secure the mediations in a locked and secure area.
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. Disinfected the medication vial septum prior to drawing up medication. 3. Disinfected the Intravenous (IV) port prior to injecting medication. 4. Wore gloves per facility policy and procedure. 5. Disposed of the fingerstick lancet after use in a puncture resistant container per facility policy and procedure. Findings include: Facility Policy: General Hand Hygiene Policy Number: None Date Reviewed: 1/23 Purpose To prevent/reduce the transmission of infectious agents from patient to employee and employee to patient. Policy All personnel shall practice general hand hygiene... Procedure A. Hand Hygiene should be performed in the following instances: Before and after patient contact Before performing a clean or sterile task such as starting an IV (intravenous) [access]...or surgical site prepping. After removing gloves... After risk for blood or body fluid exposure. ...or there is a possibility that there has been contact with blood or other potentially infectious materials. ...F. An alcohol-based hand rub may be used for routine decontamination of the hands. Facility Policy: Standard Precautions Policy Number: None Date Reviewed: 1/23 Purpose To identify practices that can be employed to protect patient and health care workers from exposure to bloodborne and body fluid pathogens... Policy Standard Precautions are implemented for every patient as the primary strategy for successful control of disease-producing micro-organisms... Procedure 1. Gloves are to be worn when handling blood or...anything contaminated with...blood... 2. Gloves are changed after contact with a patient...or contaminated items. Hands are washed as soon as gloves are removed or cleansed with an antimicrobial waterless solution. 3. Hand Hygiene should be performed after each contact with a patient...or contaminated items. 10. After use, syringes...blades, and other sharp items should be placed in a puncture resistance container for disposal...Sharps containers are located in all work areas where sharps are used. Facility Policy: Safe Injection, Infusion, and Medication Vial Practices Policy Number: None Date Reviewed: 1/23 Procedure: A. Aseptic Technique 1. Staff shall perform hand hygiene prior to accessing supplies, handling vials, and IV solutions, and preparing or administering medications and conducting point-of-care testing (e.g., blood glucose, coagulation studies) 2. Staff shall use aseptic technique in all aspects of parenteral medication administration, medication vial use, injections, and point-of-care testing. ...8. Disinfect the rubber stopper of medication vials...with sterile 70% (percent) alcohol before inserting a needle.... 10. Disinfect catheter hubs, needleless connectors, and injection ports before accessing...vigorously apply mechanical friction with...or sterile 70% isopropyl alcohol...swab.... ...C. IV solutions ...7. IV ports are disinfected using friction and 70% alcohol... ...F. Medication Vials ...6. Disinfect the rubber septum on all vials prior to each entry, even after initially removing the cap of a new unused vial. Facility Policy: Medication Administration Policy Number: None Date Reviewed: 1/21 Policy: To assist staff in the safe administration of medications ... ...11. Guidelines for routes for administration of medications. b. Intravenous injection. 1. Select injection port and cleanse with alcohol prep. 4. An observation of care, testing of an un-sampled patient's blood glucose, was conducted on 11/15/23 at 7:49 AM in the Post Acute Care Unit (PACU) Unit, Bay 8, with EI # 3, PACU, RN. EI # 3 retrieved the glucometer (a point of care device used to test capillary blood glucose levels) from the nurse station counter, and with ungloved hands cleaned the glucometer with a disinfecting cloth wipe. Without first performing hand hygiene, EI # 3 donned gloves, used a fingerstick lancet, obtained the blood sample onto the test strip, and tested the patient's blood glucose sample. EI # 3 then disposed of the fingerstick lancet into the trash and not the puncture resistant sharps container. EI # 3 failed to wear gloves when in contact with potentially contaminated items, failed to perform hand hygiene after cleaning equipment and before donning gloves, and failed to dispose of sharps into a puncture resistant container. An interview was conducted on 11/15/23 at 8:10 AM with EI # 1 who confirmed staff failed to follow the policy and procedure for hand hygiene, glove use, and sharps disposal. 1. An observation of care was conducted on 11/14/23 at 10:00 AM in Pre-op (Pre-Operative) bay 13 to observe staff prepare PI (Patient Identifier) # 12 for a Cataract Extraction with an Intraocular Lens Implant. At 10:15 AM, Employee Identifier (EI) # 4, Pre-op Nurse, without performing hand hygiene (HH), donned gloves and placed dilating gtts (drops) in the patient's right eye. Wearing the same pair of gloves, EI # 4 assembled and opened supplies to place the patient's IV catheter. After starting the IV, EI # 4 placed more dilating gtts into the patient's right eye wearing the same gloves used to start the IV. EI # 4 failed to change gloves, perform HH and re-glove between procedures. At 10:31 AM, EI # 4, without performing HH, donned gloves and applied more gtts to the patient's right eye. At 11:45 AM, the patient was in the OR (operating room) being prepared for surgery. EI # 5, CRNA (Certified Registered Nurse Anesthetist) removed gloves and without performing HH, donned gloves to tape the LMA (laryngeal mask airway) place. The gloves were removed and HH was not performed. At approximately 11:58 AM, EI # 6, Circulating Nurse, without performing HH, donned sterile gloves and prepped the patient's right eye for surgery. At approximately 12:23 PM, EI # 5, without performing HH, donned gloves and administered an IV medication. The gloves were removed and HH was not performed. At 12:33, the surgery was over. EI # 5, without performing HH, donned gloves to remove the patient's LMA and insert an oral airway. The gloves were removed and without performing HH another pair of gloves were donned.. An interview was conducted on 11/16/23 at 10:15 AM with EI # 1, Administrator, who confirmed the staff failed to perform HH according to the facility policy. 2. An observation of care was conducted for PI # 12 on 11/14/23 at 11:46 AM in OR (operating room) eight. EI # 6, circulating nurse, was observed preparing Xylocaine 1% (an anesthetic agent) for administration. EI # 6 failed to disinfect the vial's septum prior to allowing the scrub tech to withdraw the medication. An interview was conducted on 11/16/23 at 10:15 AM with EI # 1 who confirmed EI # 6 should have disinfected the vial's septum prior to allowing the scrub tech to draw from the vial. 3. An observation of care was conducted for PI # 12 on 11/14/23 at 12:07 PM in OR eight. EI # 5, CRNA, failed to disinfect the IV port prior to injecting Robinul 0.2 mg. An interview was conducted on 11/16/23 at 10:15 AM with EI # 1 who confirmed EI # 5 should have disinfected the IV port prior to injecting the Robinul.