MUSC Medical Center

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 28883 Based on record reviews, interviews, and review of hospital policy/Mosby’s Clinical Nursing Skills and Techniques, Registered Nurses #1 and #2 failed to document that an evaluation of the midline catheter had been completed to ensure it was intact on removal for 2 of 3 patients reviewed. The findings included: Record review on 12/17/25 at 9:05 AM with the Director of Accreditation and Regulation (DOAR) revealed Patient #1 was admitted to the hospital on 11/26/25 with recurrence of a paraesophageal hernia with concern for volvulus. On 11/28/25, a midline catheter was placed on the patient’s right arm for venous access, and on 12/3/25 the midline catheter was removed by Registered Nurse (RN) #1. According to the record, the midline catheter, documented as 10 centimeters (cm) long was inserted by the VAIN nursing team (vascular access nursing staff). Review of the medical record revealed there was nothing documented about whether the catheter was intact on removal or that this had been assessed to ensure part of the catheter was not retained. The finding was verified by the DOAR during the record review. During an interview on 12/17/25 at 9:33 AM, RN #3, a vascular access team nurse, stated that the floor nurses should be documenting a check of the length of the catheter upon removal. RN #3 verified s/he had been unable to find this documentation for Patient #1 as the record indicated only a date and time of removal of the midline catheter. Further review on 12/17/25 at 9:52 AM with RN #3 revealed there was a place in the electronic medical record for nursing staff to document whether the catheter was intact on removal or not. There was also a comments section where the nurse could add a note on removal and document this information. Record review on 12/17/25 at 9:40 AM with the Director of Accreditation and Regulation (DOAR) revealed Patient #2 was admitted on 11/14/25 to have a Heparin bridge (planned procedure) in anticipation of having a mitral valve replacement. On 12/1/25, Pt #1 had a midline catheter placed in the right upper arm for intravenous access, documented as 10 cm long. The midline catheter was removed on 12/4/25 by RN #2. There was nothing documented to indicate the nurse had assessed the catheter on removal to ensure the entire catheter had been removed with no pieces retained. The finding was verified by the DOAR during the record review. During interviews on 12/17/25 at 1:20 PM and 1:25 PM, RNs #1 and #2 verified they had removed midline catheters. They stated they do know to check to see whether the catheter is intact or not. The nurses stated that they chart by exception, and unless there is a problem they do not document whether catheters are intact on removal or not. RN #1 stated s/he was unaware that there was an entry that could be checked in EPIC (the electronic medical record system) to show that the catheter was intact on removal. RN #2 stated s/he was aware that there was an entry in the electronic medical record where it could be checked that the catheter was intact. RN #2 stated that though aware of this entry, it was not part of his/her process to document this information. Review of the policy provided by the hospital entitled Vascular Access Care and Management, including IV (Intravenous) Administration Sets, IV Infusion, and IV Administration, effective 3/28/25, revealed under Midline Catheter Removal, to refer to Mosby’s (clinical nursing skills handbook) for Midline Catheter removal. Review of the Mosby’s Clinical Nursing Skills and Techniques handbook, copyright 2025 by Elsevier Incorporated; revealed under the Midline Catheter Removal procedure, information for nurses to “...Evaluate the condition of the catheter and compare the length of the catheter to the original insertion length (upon removal). If the catheter length is shorter than the documented length, or if the catheter appears damaged or fragmented, notify the practitioner. Do not throw away the catheter if it is broken...”.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 36779 Based on observation, interviews, record, document and policy review, the Governing Body failed to carry out it’s functions to ensure patient safety related to medical care when one of four patient records reviewed for midline catheters, Patient 1 (P1) experienced a retained midline catheter sheath after attempted insertion by a resident physician and no action items/interventions were put in place to prevent recurrence. Findings included: Cross Reference: 1. A 263, 482.21 QAPI - Based on observation, interview, and review of medical records, documents and policies, the hospital failed to implement measures to ensure patient safety to prevent recurrence of a retained foreign body after one of four patient records reviewed for midline catheters, Patient 1 (P1) experienced a retained catheter sheath after attempted insertion of a midline catheter by a resident physician. 2. A0338, 482.22 Medical Staff - Based on observation, interview, and review of medical records and policies, the hospital failed to ensure patient safety related to insertion of midline catheters when one of four patient records reviewed for midline catheters, Patient 1 (P1) experienced a retained catheter sheath after attempted insertion of a midline catheter by a resident physician.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 36779 Based on observation, interviews, and record, document and policy review, the hospital failed to implement measures to ensure patient safety to prevent recurrence of a retained midline catheter sheath after one of four patient records reviewed for midline catheters, Patient 1 (P1) experienced a retained catheter sheath. Findings included: Cross Reference A286, 482.21 Patient Safety, Medical Errors and Adverse Events. The hospital failed to implement meaures to prevent recurrence of a retained midline catheter sheath after P1 experienced a retained midline catheter sheath after attempted insertion by a resident physician on 08/31/25. P1 had to undergo a procedure to have the foreign body removed on 09/14/25.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 36779 Based on observation, interview, and review of medical records, the hospital failed to ensure patient safety related to insertion of midline catheters when one of four patient records reviewed for midline catheters, Patient 1 (P1) experienced a retained catheter sheath after attempted insertion of a midline catheter by a Resident Physician. Findings include: 1. Cross Reference A0347, 482.22 (b) Medical Staff Organization and Accountability. The hospital failed to ensure processes and procedures were put in place to prevent patient harm when P1 retained a midline catheter sheath and had to undergo a procedure to have the foreign body removed 14 days later. 2. Cross Reference A286, 482.21 (a)(1), 482.21 (a)(2), and 482.21 (a)(3) Patient Safety, Medical Errors and Adverse Events. The hospital failed to implement preventive actions to prevent recurrence of a retained midline catheter sheath.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 36779 Based on observation, interview, and review of medical records, documents and policies, the hospital failed to implement measures to ensure patient safety to prevent recurrence of a retained foreign body after one of four patient records reviewed for midline catheters, Patient 1 (P1) experienced a retained catheter sheath after attempted insertion of a midline catheter by a resident physician. Findings include: Review of the hospital’s policy titled, “Event Investigation & Analaysis” on 11/04/25 at 12:43 PM revealed, “...Definitions...A sentinel event is a patient safety event...is...Unintended retention of a foreign object in a patient after an invasive procedure...Policy...It is the policy of MUSC Health to immediately begin an investigation into safety events...If is the goal of MUSC Health to Improve patient care by gaining knowledge about adverse outcomes and to implement improvement activities to prevent such events...” Review of P1’s record began on 11/04/25 at 2:45 PM with Manager of Regulatory and Accreditation (MRA) 1 and MRA2. P1 was admitted to the hospital on 08/06/25 through the Emergency Department and transferred to the Medical Surgical Intensive Care Unit (MSICU) on 08/09/25, transferred to the Cardiothoracic Intensive Care Unit (CTICU) on 08/15/25, transferred out of the CTICU on 09/09/25 and discharged from the hospital on 10/11/25. No documentation of attempted or successful insertion of a midline catheter could be found in the record. MRA2 stated it was a resident who attempted insertion of a midline catheter, not nursing. On 11/04/25 at 3:45 PM, review of the hospital’s quality investigation document titled, “IMPROVE PROJECT A3 SUMMARY,” (undated) revealed the implementation plan actions were “2 person verification all parts and pieces are intact and removed” and “Documentation of procedure attempts successful or unsuccessful.” However, no documentation could be found in P1’s record of an attempted midline catheter insertion. The Quality and Safety Director for Heart and Vascular (QSDHV) joined the record review at 3:52 PM. When asked how it was determined who attempted midline insertion for P1, she/he stated it was through interviews. Continued review of P1’s record on 11/04/25 at 4:00 PM revealed a Progress Note by Resident Medical Doctor (RMD) 7 dated 8/31/25 revealed, “...Plan...Midline...” Review of the Discharge (DC) Summary from the Cardiothoracic Intensive Care Unit (CTICU) dated 9/14/25 by Physician’s Assistant (PA) 8 revealed, “...[P1] mentioned LUE [left upper extremity] tenderness and discomfort. Able to palpate what feels like a foreign object under the skin. XR [xray] shows It [sic] is in the skin and not an artery. Plan for removal today...” Review of a Procedure Note by RMD9 dated 9/14/25 at 1:49 PM revealed, “ ...Type...retained catheter...Body area...L [left] upper arm...The L arm was palpated and appeared to be a catheter in the area ...There was noted to be a fibrous sheath around the object ...was dissected ...An area of the catheter was exposed and grasped with the hemostat and then removed from the body in one piece ...” The Quality and Safety Director for Heart and Vascular (QSDHV) joined the record review at 3:52 PM. When asked how it was determined who attempted midline insertion for P1 since there was no documentation of it in P1’s record, she/he stated it was through interviews. Continued review of P1’s record revealed a nursing note dated 8/31/25 at 8:25 PM which indicated, “Critical Test Results Notification and Provider Notification...Pt [patient] complaining of pain in left upper arm near previous midline attempt insertion site. Site is tender to touch and a skinny bar-like lump was noted on palpation...” In an interview with MD3 on 11/05/25 at 12:15 PM, she/he stated she/he oversees the residents. She/he stated she/he wasn’t sure if they were supposed to document attempted insertion or insertion of midline catheters. She/he stated, “Ultimately, it’s up to the Program Director (PD) to assess their (the resident’s) skills.” She/he stated she/he had not reviewed this incident completely. She/he stated the PD’s for the residents who attempted midline catheter insertion were Medical Doctor Program Director (MDPD) 1 who supervised RMD7 and MDPD2 who supervised Fellow Medical Doctor (FMD) 6. In an interview with FMD6 on 11/05/25 at 1:25 PM, he/she confirmed he/she attempted insertion of a midline catheter for P1 on 09/04/25 to the right upper extremity (RUE). When asked if he/she would be able to see that a part of the sheath was missing after an attempted insertion of a midline catheter, he/she stated with a central line he/she looks at the length and guesses, but because this was a midline and it was not advanced it would come out in one piece. When asked if he/she was doing anything differently when inserting midline catheters since the incident that occurred with P1, he/she stated he/she attempted on the right side and the incident was on the left. When asked if not documenting failed attempts was normal, he/she stated until this incident he/she did not document failed attempts but “Most definitely I should.” He/she did not state anything about implementation of a two-person verification or any other action items/interventions to prevent recurrence of a retained midline catheter sheath. In an interview with RMD7 on 11/05/25 at 3:34 PM, regarding an attempted midline catheter insertion for P1 on 08/31/25, she/he stated, “I attempted a midline placement on the left upper extremity and I removed, to my knowledge, everything and I did not leave any documentation. I should have.” When asked what had been changed to prevent recurrence of a retained midline catheter sheath, RMD7 stated, “After this when it came to light, I need to remember to document everything. RMD7 did not state a two person verification was a new process requirement or any other action items/interventions had been implemented to prevent recurrence of a retained midline catheter sheath. On 11/05/25 at 4:00 PM, a midline catheter insertion kit was observed. The sheath measured three inches. This was confirmed by MRA1. On 11/05/25 at 4:40 PM, Risk Manager (RM) 1 was interviewed and the retained midline catheter sheath that was removed from P1 on 09/14/25 was observed. RM1 and MRA1 confirmed the sheath was approximately two inches long. (The sheath was originally three inches long, therefore only one inch would have been remaining when the Provider removed it from P1’s arm.) On 11/06/25 at 7:42 AM, in an interview with MDPD1, she/he confirmed she/he was a PD with oversight of the general surgery residents. When asked what had been done to prevent recurrence of a retained piece of a midline catheter sheath since the incident with P1, she/he stated there was not specific training for this for residents. She/he stated the residents only place midline catheters in the CTICU unit. She/he stated she/he sent out a “formal email to the residents and then had an in person talk during their dedicated didactic time.” She/he stated she/he only oversees CT surgery, but Vascular surgery also serves that unit and “That’s why [MDPD3’s name] has taken the lead in this action plan.” Review of the email MDPD1 referenced and presented by MRA2 (right after the interview) revealed it was sent by MDPD1 on 09/29/25 and only addressed documenting failed procedure attempts. There was nothing in the email indicating any interventions to prevent recurrence of a retained midline catheter sheath and nothing about two-person verification as an action item/intervention.) In an interview with MDPD2 at 7:55 AM on 11/06/25, when asked what had been done to prevent recurrence of a retained midline catheter sheath, he/she stated, “We didn’t always educate residents what to do during failed attempts.” He/she stated he/she had instructed the three fellows he oversees to document failed attempts. MDPD2 did not state anything about a two-person verification or any other action item/intervention to prevent recurrence of a retained midline catheter sheath. During an interview on 11/06/25 at 8:15 AM with Registered Nurse (RN) 1, she/he confirmed caring for P1 on 08/31/25. She/he stated P1 complained of pain to her arm where there had been an attempted midline catheter insertion earlier that day, and when she/he assessed it, “It was a little warm and it felt like there was something in there like a Nexplanon (implanted medication device used for birth control) in someone’s arm, like a skinny bar object and I told my provider.” The CTICU Nurse Manager (NM) 1, who was also present, stated, “Nurses do not place midlines on that unit at all.” In an interview with the MRA2 on 11/06/25 at 8:21 AM, she/he stated the CT Surgeon in the CTICU that oversees the CTICU residency in that unit is MDPD3 (indicated by MDPD1 as lead person working on the incident with P1), but he/she is not available for interview this week. In an interview with Risk Management Coordinator (RMC) 16 on 11/06/25 at 9:12 AM, she/he stated in their investigation, they determined in staff interviews that there were multiple residents/fellows who had attempted midline insertion and none of those attempts were documented. She/he stated one resident attempted in the right arm and was unsuccessful and there was no progress or procedure note documented. She/he stated they got a leader huddle together the next day and they went over their two-person verification that they use for their arterial lines in the ICU; and “Anytime they are placing a line in a patient there needs to be a two-person verification.” RMC16 stated at the time of the incident with P1, “we were treating midlines more like a peripheral line. We decided to do them like central lines moving forward. We all discussed that all residents and attendings needed to have documentation of attempts, successful or not, of midlines, and any line that they are placing.” She/he stated, “It is our expectation that they immediately disseminate that information.” When asked how it is determined that the information was disseminated and implemented, she/he stated, “There’s nothing in place right now to make sure the responsible parties actually do what was decided as the action plan.” RMC16 was informed that interviews with residents and fellows revealed no action items/interventions were implemented to prevent recurrence of a retained midline catheter sheath. She/he stated, “We did deem this was a serious safety event (SSE) and a sentinel event which she/he defines as anything that is reportable to the accrediting organization or the state department of public health. She/he stated all sentinel events require an Action Plan Meeting. She/he stated the Action Plan Meeting was on 10/02/25 and that’s where the A3 (the hospitals root cause analysis - RCA), action plan and goals were determined. She/he stated everyone involved is in the Action Plan Meeting, “So, yes, they should carry out ...please start your work now ...these are your goals and begin your goals prior to receiving the finalized A3 which she states she sent out 10/7/25. On 11/06/25 at 10:09 AM, MRA2 stated the next meeting regarding the incident with P1 was the Improve Meeting and that is scheduled in December. Review of the QAPI Meeting Minutes for Heart and Vascular dated 10/24/25 on 11/06/25 at 10:13 AM revealed, “Foreign Retained Object ...will be presented at Improve in December.” During an interview on 11/06/25 at 11:34 AM with the Chief Medical Officer (CMO), he/she stated the Chief Quality Officer brought it (incident with P1 of retained sheath) up in our ELC (Executive Leadership Team) which is where he/she first became aware of this incident. He/she stated he/she wants to wait for the recommendations and see what the team says. In an interview with MRA2 on 11/06/25 at 12:15 PM, she/he stated RM1 said although it’s not in a policy, the results from the Leadership Huddle on 09/15/25 for the two-person verification should have been cascaded from there to ensure it was carried out. In an interview with the CQO on 11/06/25 at 1:28 PM, he/she described the quality process for the incident with P1 and the retained midline catheter sheath. He/she stated all events with patient harm go to all executive leadership as an alert. He/she stated the risk group that’s responsible for doing the actual investigation reports to him/her and they review it and score it. When asked what changes were made to prevent recurrence of a retained midline catheter sheath and if a leadership huddle/meeting occurred after the incident with P1, the CQO confirmed there is an “immediate” team meeting to discuss what actions can be put in place to make sure something similar doesn’t happen again. He/she stated, “The problem with midlines is they have pieces that are similar to a central line and we have processes for central lines ...for the midline we need to switch that mentality from peripheral to moving it into the category into the central line to ensure there’s always someone there to help so really a second person in place ...a nurse ...we already have that process for standard central lines...” He/she did not indicate a two-person verification or any other action item/intervention had been implemented to prevent recurrence of a retained midline catheter sheath.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 36779 Based on observation, interview, and review of medical records and policies, the hospital failed to ensure patient safety related to insertion of midline catheters when one of four patient records reviewed for midline catheters, Patient 1 (P1) experienced a retained catheter sheath after attempted insertion of a midline catheter by a resident physician. Findings included: On 11/04/25 at 12:43 PM, review of the hospital’s policy titled, “Event Investigation & Analysis” dated 04/03/23, revealed, “...Definitions...A sentinel event is a patient safety event...that reaches a patient...The event is one of the following...Unintended retention of a foreign object in a patient after an invasive procedure...Policy...It is the policy of MUSC Health to immediately begin an investigation into safety events...It is the goal of MUSC Health to improve patient care by gaining knowledge about adverse outcomes and to implement improvement activities to prevent such events.” Review of the Medical Staff Rules and Regulations on 11/05/25 revealed, “PATIENT SAFETY INITIATIVES...All members of the medical staff are required to follow all guidelines/policies related [sic] the National Patient Safety Goals and other patient safety initiates. These policies include but are not limited to the following...”Event Investigation & Analysis.” Review of P1’s record began on 11/04/25 at 2:45 PM with Manager of Regulatory and Accreditation (MRA) 1 and MRA2. P1 was admitted to the hospital on 08/06/25 through the Emergency Department and transferred to the Medical Surgical Intensive Care Unit (MSICU) on 08/09/25, transferred to the Cardiothoracic Intensive Care Unit (CTICU) on 08/15/25, transferred out of the CTICU on 09/09/25 and discharged from the hospital on 10/11/25. No documentation of midline catheter insertion or attempted insertion could be found in the record. MRA2 stated it was a resident (physician) who attempted insertion of a midline catheter, not nursing. Review of a Progress Note by Resident Medical Doctor (RMD) 7 dated 8/31/25 revealed, “...Plan...Midline...” Review of the Discharge (DC) Summary from the Cardiothoracic Intensive Care Unit (CTICU) dated 9/14/25 by Physician’s Assistant (PA) 8 revealed, “...[P1] mentioned LUE [left upper extremity] tenderness and discomfort. Able to palpate what feels like a foreign object under the skin. XR [xray] shows It [sic] is in the skin and not an artery. Plan for removal today...” Review of a Procedure Note by RMD9 dated 9/14/25 at 1:49 PM revealed, “ ...Type...retained catheter...Body area...L [left] upper arm...The L arm was palpated and appeared to be a catheter in the area ...There was noted to be a fibrous sheath around the object ...was dissected ...An area of the catheter was exposed and grasped with the hemostat and then removed from the body in one piece ...” Continued review of P1’s record revealed a nursing note dated 8/31/25 at 8:25 PM which indicated, “Critical Test Results Notification and Provider Notification...Pt [patient] complaining of pain in left upper arm near previous midline attempt insertion site. Site is tender to touch and a skinny bar-like lump was noted on palpation...” In an interview with MD3 on 11/05/25 at 12:15 PM, she/he stated she/he oversees the residents. She/he stated she/he wasn’t sure if they were supposed to document attempted or successful insertion of midline catheters. She/he stated, “Ultimately, it’s up to the Program Director (PD) to assess their (the resident’s) skills.” She/he stated she/he had not reviewed this incident completely. She/he stated the PD’s for the Residents who attempted midline catheter insertion were Medical Doctor Program Director (MDPD) 1 who supervised RMD7 and MDPD2 who supervised Fellow Medical Doctor (FMD) 6. In an interview with RMD7 on 11/05/25 at 3:34 PM, regarding an attempted midline catheter insertion for P1 on 08/31/25, she/he stated, “I attempted a midline placement on the left upper extremity and I removed, to my knowledge, everything and I did not leave any documentation.” On 11/05/25 at 4:00 PM, a midline catheter insertion kit was observed. The sheath measured three inches. This was confirmed by MRA1. On 11/05/25 at 4:40 PM, Risk Manager (RM) 1 was interviewed and the retained midline catheter sheath that was removed from P1 on 09/14/25 was observed. RM1 and MRA1 confirmed the sheath was approximately two inches long. (The sheath was originally three inches long, therefore only one inch would have been remaining when the Provider removed it from P1’s arm.) During an interview on 11/06/25 at 8:15 AM with Registered Nurse (RN) 1, she/he confirmed caring for P1 on 08/31/25. She/he stated P1 complained of pain to her arm where there had been an attempted midline catheter insertion earlier that day, and when she/he assessed it, “It was a little warm and it felt like there was something in there like a Nexplanon (implanted medication device used for birth control) in someone’s arm, like a skinny bar object and I told my provider.” The CTICU Nurse Manager (NM) 1, who was also present, stated, “Nurses do not place midlines on that unit at all.” In an interview with RMD4 at 1:52 PM on 11/06/25, she/he confirmed she/he was notified by RN1 on 08/31/25 of assessment findings of P1’s left arm. RMD4 stated P1 “was having some irritation in her left upper extremity and how it was just strange ... felt like a superficial thrombosis ...I remember her and they attempted a midline.” She/he stated she/he thought “maybe it was a clot from the placement because I’ve just never seen that.” She/he stated she/he palpated and “It really did feel like a Nexplanon but superficial. I have now since placed a midline and understand that kit and how it could break off ...at that time I just hadn’t seen the kit before.” After attempted insertion of a midline catheter to the left upper extremity for P1 on 08/31/25, she/he complained of pain to the left upper extremity that evening to RN1. RN1 palpated a “skinny bar object” and notified RMD4 who performed a physical assessment and palpated an object that felt like a Nexplanon” but thought it was a superficial thrombosis. The retained sheath was removed on 09/14/25.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 30260 Based on record review, staff interview, and review of the hospital’s policies and procedures, the hospital failed to ensure the correct location was biopsied for one of four sampled patients, Patient (P)1. This failure had the potential to place to all patients presenting to the radiology department for biopsy procedures in jeopardy of wrong site procedures. Findings included: On 08/07/25 at 1:27 PM, the Director of Regulatory Affairs and the Program Manager of Accreditation and Regulatory Affairs were notified of Immediate Jeopardy (IJ) under A0940 Surgical Services related to the failure of the facility to ensure the correct site was biopsied during an ultrasound-guided biopsy procedure on 07/28/25, and failure to immediately implement and document corrective actions to prevent a recurrence of the event. The facility submitted an acceptable Removal Plan on 08/07/25 at 7:47 PM. The survey team validated the Immediate Jeopardy was removed on 08/08/25 at 1:15 PM following the facility’s implementation of the Removal Plan. Condition level deficiencies remained for Surgical Services at 42 CFR 482.51. Cross reference A0951- Operating Room Policies - Polices that govern surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. Cross reference A0955 -Informed Consent -A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 30260 Based on record review, staff interviews, and review of hospital policies and procedures, the hospital failed to ensure a biopsy was obtained from the correct location for one of four sampled patients, Patient (P)1. This failure had the potential to place to all patients presenting to the radiology department for biopsy procedures in jeopardy of wrong site procedures. Findings included: Review or the facility’s policy titled, “Universal Protocol for Operative/Procedural Areas origination date: 09/01/03, revealed, “Policy Statement: All ... staff are responsible for the safety of the operative/procedural patient and will follow the verification of procedure protocol for Time-Out prior to all surgical and other invasive procedures...Policy Purpose: To prevent wrong patient, wrong procedure, or wrong site surgeries including side, digit, and level, by providing patient care providers with specific expectations and procedures to follow throughout the perioperative process. The following verification of procedure will take place for all surgical and other invasive procedures in all inpatient and outpatient clinical settings, including procedures at the bedside. The operation/procedure must be stopped if there is any discrepancy and/or disagreement amongst team members. The discrepancy/disagreement must be resolved before proceeding with the surgery/procedure without compromising patient safety or causing clinical deterioration. Patient safety is a shared responsibility among all team members and must be taken seriously to ensure the highest quality of patient safety and trust...Scope: This policy applies to all MUSC (Medical University of South Carolina) operative settings, invasive procedure departments, to all invasive and operative procedures, and for all employees who take part in any surgical or invasive procedure performed on a patient...Policy: I. Surgical/Procedural Time-Out Process A. Pre-Operative/Pre-Procedure Verification 1. Verification of the correct person, correct procedure site, and correct side must occur (as applicable) ...F. Operation/Procedure Time-Out 1. A deliberate pause of all operative/procedural team members involving clear communication, active listening and verbal communication that occurs before starting the operation/procedure, is led by the qualified individual responsible for and credentialed to independently perform the operation/procedure, and includes any additional Attending, Fellow, or Resident surgeons, NP/PA, anesthesiology provider, nurses, techs, and all other staff in attendance at the start of the case...4. The signed consent and the patient’s armband is referenced during the Operation/Procedure Time-Out and includes: b. Correct procedure. c. Correct site/side/level/digit - verified by site marking and visible after prep and draping... e. Relevant images and/or test results are properly labeled and appropriately displayed.” Review of P1’s electronic medical record revealed he/she was admitted to the facility’s Cancer Center on 07/28/25 for an ultrasound guided biopsy procedure. A procedure narrative for P1’s first biopsy, dated 07/28/25, signed by Attending Physician (MD)2 and Radiology Resident (RR)1 on 07/29/25 and acknowledged by Physician Assistant (PAC)1 on 07/31/25 at 4:45 PM; revealed “... patient presents for ultrasound guided biopsy of 0.5 cm (centimeter) mass in the left breast at 11 o’clock, 4 cm from the nipple. PATIENT CONSENT: An ultrasound guided biopsy procedure with potential risks and complications was explained in full to the patient. Written and verbal consent were obtained prior to the initiation of the procedure. PROCEDURE DESCRIPTION: MD2 was present for the entire procedure, and there were no overlapping procedures. COMPARISON: The present examination has been compared to a prior imaging study performed at Hollings Cancer Center Breast Imaging Program on 07/22/25. An ultrasound guided biopsy was performed for the 0.5 cm mass located in the left breast at 11 o’clock 4 cm from the nipple using real-time ultrasound. This was described on the previous ultrasound report. The skin was prepped in the usual manner. Local anesthetic was administered to the site. A skin nick was made in the breast. The abnormality was approached from the medial aspect. A 14-gauge biopsy needle was placed adjacent to the abnormality under ultrasound guidance and confirmatory ultrasound images were obtained to document needle placement. Once the needle was documented to be in the correct location, three specimen(s) were obtained using BARD biopsy device. A Twirl clip was inserted into the targeted area under ultrasound guidance. A skin closure strip was applied to the access site. Post-placement mammographic images were obtained which demonstrates appropriate placement to the targeted area. The specimens were sent to the laboratory for pathologic analysis. Impression: ...Ultrasound guided biopsy of the 0.5 cm mass in the left breast at 11 o’clock 4 cm from the nipple with the placement of clip was successful with no apparent post procedure complications. This was labeled as A. Samples sent for analysis. Waiting for pathology results. An addendum will be placed on this procedure report when these become available.” A procedure narrative dated 07/28/25 for P1’s second biopsy revealed, “ ...patient presents for ultrasound guided biopsy of mass in the left breast retroareolar. PATIENT CONSENT: An ultrasound guided biopsy procedure with potential risks and complications was explained in full to the patient. Written and verbal consent were obtained prior to the initiation of the procedure. PROCEDURE DESCRIPTION: (MD2) was present for the entire procedure, and there were no overlapping procedures. COMPARISON: The present examination has been compared to a prior imaging study performed at Cancer Center Breast Imaging Program on 07/22/2025. An ultrasound guided biopsy was performed for the mass located in the left breast retro-areolar using real-time ultrasound. This was described on the previous ultrasound report. The skin was prepped in the usual manner. Local anesthetic was administered to the site. A skin nick was made in the breast. The abnormality was approached from the lateral aspect. A 16-gauge biopsy needle was placed adjacent to the abnormality under ultrasound guidance and confirmatory ultrasound images were obtained to document needle placement. Once the needle was documented to be in the correct location, two specimen(s) were obtained... A Coil clip was inserted into the targeted area under ultrasound guidance. A sterile dressing was applied to access site. Post-placement ultrasound images were obtained which demonstrates appropriate placement to the targeted area. The specimens were sent to the laboratory for pathological analysis. Impression: ...Ultrasound guided biopsy of the mass in the left breast retro-areolar with the placement of clip was successful with no apparent post procedure complications. This was labeled as B. Samples sent for analysis. Waiting for pathology results. An addendum will be placed on this procedure report when these become available.” Review of P1’s electronic medical record revealed a Physician Assistant (PAC)1 progress note that included a message from P1 dated 07/30/25 which documented, “The first radiologist identified two areas, one at 11 o’clock and one at 1 o’clock on my left breast the one at 11 o’clock, [he]/she was suspicious about however {sic} the one at 1 o’clock, [he]/she wanted to do a biopsy on. They originally done {sic} the biopsy on 11 o’clock and I kept telling them I felt like it was the wrong place and then when I was headed out Radiologist or attendant came in and told me it was biopsied wrong and needed to do the 1 o’clock one ...Also wanted to ask did the results include tissue samples from two different biopsies taken (one at 11:00 and other at 1:00 from left breast)? Long story short, they messed up and biopsied wrong area! But want to make sure results from both ...” During an interview 08/05/25 at 2:40 PM, the Director of Risk Management and Patient Safety (DRMPS) stated the facility self-reported an event that involved an ultrasound guided biopsy performed by radiology resident (RR)1. The benign lesion image was displayed instead of the intended target lesion image and the biopsy was performed on the wrong site. The error was caught by RR1 who performed the biopsy when he/she went to the reading room to review the biopsy images and read the result of the ultrasound. DRMPS stated an attending physician (MD)2 was in the room with the RR1 during the biopsy but did not catch the error. When RR1 realized the error MD2 was immediately informed. The error was identified before the patient left the radiology department and was explained to the patient. A biopsy of the correct lesion in the left breast was subsequently obtained by MD2 prior to the patient leaving the facility. When asked what the facility had implemented after the incident, DRMPS stated a SHIELD (safety heroes implementing event learning and discovery - the facility’s incident report system) event had been started. DRMPS stated the incident was discussed and training in time-out education and labeling of images would ensure this incident did not happen again. DRMPS stated the facility had not taken any formal action to prevent the incident from occurring to other patients because it was a fairly new event and the Root Cause Analysis (RCA) meeting was scheduled for 08/12/25 and the event would be discussed and the RCA conducted at that meeting. DRMPS stated the facility did not have a completed action plan because it was too soon since the incident occurred, but there was a discussion with the attending physician involved. DRMPS stated he/she reported the event to the leadership team that meets every Monday but did not have written documentation of any report or leadership action. During an interview on 08/06/25 at 10:01 AM Radiologic Technician (RT)1, stated he/she specialized in Mammography, and had been an RT for 28 years. RT1 stated his/her role in ultrasound guided mammograms was to bring the patient back in the procedure room, verify the patient’s name and date of birth, the correct breast for biopsy, and give the doctor the consent form to read. RT1 set up the sterile tray for the procedure and the projected picture of the ultrasound. RT1 stated he/she was not ultrasound trained and was not in the room as an ultrasound technologist, but there to assist with the procedure. RT1 stated he/she was present during P1’s first ultrasound guided biopsy on 07/28/25. RT1 stated he/she had an image of the patient’s left breast pulled up on the screen that was one of many images of the left breast pulled up. RT1 stated what he/she could recall from the procedure on 07/28/25 was normal fashion, the Radiologist scanned the area to biopsy, marked the skin and performed the scrub and positioned the patient.. A sterile drape was placed on the patient, and the Radiologist scrubbed the patient’s skin and got the probe ready. MD2 came in and a time-out was performed. RT1 stated he/she projected and labeled the original ultrasound on the screen. MD2 and the ultrasound technologist confirmed it was the correct image of the site intended to biopsy. All agreed on the site and marker clips were put in. Pictures of the clips were taken after the biopsy. When finishing in the room, MD2 came knocking and informed the patient the biopsy was performed on the wrong area and another biopsy needed to be done. The clip pictures alerted the Radiologist of the wrong position, and another biopsy was performed. When asked how the wrong image was projected on the screen RT1 stated the patient had a mammogram and ultrasound done the week prior to the biopsy. Multiple images were pulled up. During an interview on 08/06/25 at 12:25 PM, Fourth-year RR1 stated he/she performed P1’s first ultrasound guided biopsy on 07/28/25. RR1 stated he/she was not a surgical resident, but that Radiologists performed many image-guided invasive procedures, including ultrasound guided biopsies. RR1 confirmed that during an ultrasound guided biopsy, the skin is punctured to obtain a tissue sample for biopsy. RR1 stated P1 had three lesions in the left breast. They were all hypoechoic (a structure appearing darker than surrounding; tissues may be indicative of denser tissue associated massed or tumors) lesions. All lesions were fairly similar in appearance. RR1 stated before he/she goes into any procedure, the images are pulled up in the reading room. In this case, the lesion that was supposed to be biopsied was labeled as retro-areolar (behind the nipple). RR1 stated he/she looked at the images immediately prior to walking into the procedure room. RR1 stated he/she did not realize the technologist pulled up the wrong image on the computer screen in the biopsy room. The image that was pulled up was labeled 11:00 o’clock, 3 cm. RR1 stated the image on the screen did not raise a red flag in his/her mind because it was so close to the correct one. RR1 stated the biopsy was started and the lesion was found, but it was the wrong lesion. RR1 stated an ultrasound technologist came into the room and also verified they were in the correct place, but the ultrasound technologist was looking at the computer screen in the room, which had the wrong image displayed. RR1 stated MD2 came into the room and the team did a time out. MD2 looked at the screen and assumed the correct image was on display. RR1 stated as soon as he/she got back to the reading room to dictate the summary and pulled up the prior images, he/she realized the biopsy was performed on the wrong site. RR1 stated MD2 was immediately informed and went to talk with the patient. The patient agreed to have a biopsy of the correct site which was performed by MD2. RR1 stated he/she self-reported the event in SHIELD. When asked who was responsible for putting up the wrong series of diagnostic images on the screen, RR1 stated he/she was ultimately responsible for double checking the images when he/she got to the procedure room. When asked if any safety measures had been implemented since the incident, RR1 stated there was a serious safety solutions (SSS) meeting scheduled for the following week, where the incident would be discussed, but no formal steps have been taken to correct the issue.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 30260 Based on record review, staff interviews, and policy review, the hospital failed to ensure a properly executed Informed Consent form was in the medical record for two invasive biopsy procedures performed for Patient (P)1, one of four patients who presented to the facility’s Outpatient Cancer Center for an ultrasound-guided biopsy. This deficient practice had the potential to affect all patients who have invasive biopsy procedures at the hospital. Findings included: Review of the “Medical Staff Rules and Regulations” dated 02/10/23 revealed, “ ...Informed Consent Requirements. It is the responsibility of the attending physician, APRN (Advanced Practice Registered Nurse), PA-C (Physician Assistant-Certified), resident, or intern to assure appropriate informed consent is obtained and documented in the medical record and when appropriate, also document the discussion in a progress note if the provider is present during the procedure. For surgical procedures only, the provider needs to be present for invasive procedures, for the use of anesthesia, including moderate and deep sedation, and for the use of blood and blood products. Appropriate informed consent shall include the following at a minimum:- Patient identity, -Date, -Procedure or treatment to be performed, -Name of person performing the procedure or treatment, -Authorization for the proposed procedure, -Authorization for anesthesia or moderate sedation if indicated, -Indication that alternate means, risk and complications of the planned procedure and recuperation, and anesthesia have been explained, -Authorization for disposition of any tissue or body parts as indicated, -Risks and complications of blood or blood product usage (if appropriate), -Witnessed signature of the patient or other empowered individual authorizing informed consent, and -Signature, name/identity, and pager # of the physician, APRN or PA-C who obtained the consent, (verbal consent may be witnessed by the nurse and indicated on the consent form), Physician, APRN or PA-C documentation of the consent process in a progress note or on the consent form. Physician, APRN or PA-C documentation of the consent process and discussion may be accomplished with either an out-patient or in-patient note in the record.” Review of P1’s electronic medical record revealed P1 underwent two biopsies on 07/28/25. Review of the procedure narrative dated 07/28/25 revealed, “...patient presents for ultrasound guided biopsy of mass in the left breast retroareolar. PATIENT CONSENT: An ultrasound guided biopsy procedure with potential risks and complications was explained in full to the patient. Written and verbal consent were obtained prior to the initiation of the procedure. PROCEDURE DESCRIPTION: (MD2) was present for the entire procedure, and there were no overlapping procedures. COMPARISON: The present examination has been compared to a prior imaging study performed at Cancer Center Breast Imaging Program on 07/22/2025. An ultrasound guided biopsy was performed for the mass located in the left breast retro-areolar using real-time ultrasound...The skin was prepped in the usual manner. Local anesthetic was administered to the site. A skin nick was made in the breast. The abnormality was approached from the lateral aspect. A 16-gauge biopsy needle was placed adjacent to the abnormality under ultrasound guidance and confirmatory ultrasound images were obtained to document needle placement. Once the needle was documented to be in the correct location, two specimen(s) were obtained... A Coil clip was inserted into the targeted area under ultrasound guidance. A sterile dressing was applied to access site. Post-placement ultrasound images were obtained which demonstrates appropriate placement to the targeted area. The specimens were sent to the laboratory for pathologic {sic}analysis. Impression: ...Ultrasound guided biopsy of the mass in the left breast retro-areolar with the placement of clip was successful with no apparent post procedure complications. This was labeled as B. Samples sent for analysis. Waiting for pathology results. An addendum will be placed on this procedure report when these become available.” Review of the medical record did not include an Informed Consent for the two biopsy procedures performed on 07/28/25. During an interview on 08/06/25 at 12:37 PM, the Director of Regulatory Affairs (DRA) was informed the procedure Informed Consent forms for the two biopsies conducted on 07/28/25 could not be located in P1’s electronic medical record. The DRA stated he/she would reach out to medical records to obtain the consent forms. During an interview on 08/06/25 at 4:08 PM, the DRA stated the P1’s Informed Consent forms for the biopsy procedures could not be located. During an interview on 08/06/25 at 12:25 PM, Fourth-year Radiology Resident (RR) 1 stated he/she performed the first ultrasound guided biopsy on P1 on 07/28/25. RR1 stated before biopsy procedures he/she obtains the patient’s consent form for the procedure, and explains the risks and benefits of the procedure, as well as alternatives to the procedure and asks asks the patient if they had any questions. RR1 stated the patient and the physician sign the consent form. When shown the General Informed Consent in the P1’s medical record that was presented to the surveyor, RR1 stated the form was not the Informed Consent form he/she filled out for the biopsy procedure, and the form lacked his/her signature. RR1 stated he/she did not know if an Informed Consent form was obtained for the second biopsy because the attending physician (MD)2 conducted the second biopsy. MD2 was not available for interview.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 36779 Based on observation, interview, and record review the hospital failed to put measures in place to ensure a piece of port-a-cath (central venous catheter - inserted in a large vein) was not retained when the central line was removed/explanted for one of one patients reviewed for central lines, Patient 2 (P2). The findings included: Review of P2’s record on 07/14/25 at 12:35 PM revealed a computed tomography (CT - a type of x-ray image) scan report dated 05/08/25 which read, “ ...Tubular hyperdensity within the left chest wall with soft tissues which may represent a retained tubing ...” Review of the Interval History and Physical (H & P) Note by surgeon (MD4) on 5/21/2025 at 1:25 PM revealed, “ ...On evaluation of the patient’s right breast we note there was a small area of Was Taken [sic] with the Specimen. The Implant Remained Flat ...Specimens ...left chest retained object for gross id [identification] ...Type ...Foreign Body ...Source ...Chest ... Collected by ...[MD4’s name] ...Time ...5/21/2025 4:08 PM ...Findings ...blue foreign body removed from left upper chest ...Synoptic Reporting ...The [sic] was a palpable abnormality under the skin in the left upper chest, immediately deep to the healed port site scar. An incision was made in the skin of the left chest with a scalpel following the scar from the patient prior [sic] port. Bovie electrocautery was used to dissect through the subcutaneous tissues. The foreign body was freed from the surrounding subcutaneous tissues and passed off for gross identification ...” Review of the pathology reports from surgeries 10/20/22 and 5/21/25 reviewed revealed gross identification of a port on 10/20/22 and a small piece of tube with a suture on 05/21/25. An interview was conducted with the Director of ART OR Perioperative (DARTP) on 07/16/25 at 10:32 AM. The DARTP stated she remembered the case of P2 with the retained foreign body (FB). She stated the port-a-cath was removed on 10/20/22 when P2 was having another surgical procedure done in the ART OR. The DARTP stated, “We don’t remove many ports in ART, usually in VIR (vascular interventional radiology) or in clinic.” The DARTP stated the surgeon removes it (FB) and hands it to the scrub nurse and it gets documented and sent to pathology for gross ID (identification). When asked how a piece of a port-a-cath gets left (in the patient) she stated, “I don’t know. When asked how it will be prevented from happening again, she stated, “The only way we would be able to get it all would be an x-ray.” She stated, “an x-ray was not policy and is not - we’re working on trying to find as a group to find solutions.” She stated they had some “initial meetings with ...Quality and Safety and there’s been a couple of them ...it was mainly a surgeon issue.” She stated she does not know if that’s why port (port-a-cath) removals are typically done in VIR or what their (VIR’s) policy is for port removal. The DARTP stated all options were being considered including films. Review of the Root Cause Analysis (RCA) on 07/16/25 at 9:57 AM revealed the case was taken to peer review but no measures were identified or put in place to ensure patients having removal of port-a-cath’s and central lines in the ART OR did not have pieces of the catheter inadvertently left in the patients (retained FB). An interview was conducted with the System Director of Risk (SDR) on 07/17/25 at 1:35 PM. The SDR stated the RCA involving P2 was just created on 06/30/25 and has not been to the hospital’s Improve Meeting yet which she said occurs approximately 30-45 days after the action plan is created and approved. A phone interview was conducted with the Operations Manager of Vascular and Interventional Radiology (OMVIRS) on 07/17/25 at 5:13 PM and the Director of Regulatory Affairs (DRA) was present. The OMVIRS confirmed port-a-caths and central line removal is normally done in the VIR department. He stated the process for removal of port-a-cath is to “do a ‘scout shot’ (imaging) to visualize where it is ...an incision is made and the accepting part of the port-a-cath ...under the skin ...a wire is passed once that hub part is taken off and the sheath is removed over that wire to ensure no adhesions ...hemostasis is maintained ...maybe another shot immediately after removing that ...sew up the pockets and take an additional shot at that point ...assure that nothing is remaining and that is what we would do with fluoroscopy ...” The OMVIRS confirmed they always do imaging after port-a-cath removal to “ensure everything has been removed” and he stated, “Anything that’s in vascular you can’t see that in the OR but you would see it on fluoroscopy.” In an interview with the DAR after the phone call, she confirmed there was no documented evidence measures had been put in place to prevent a recurrence of a piece of a port-a-cath/central line being retained when they are removed in the ART OR.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 36779 Based on observation, interview, record review and review of the hospital’s policy the hospital failed to ensure a properly executed written consent was obtained for one of four patients reviewed for surgical and procedure consents, Patient 3 (P3) when the location and laterality (side of the body) the procedure was to be done on was not included in the written consent. The findings included: Review of P3’s record on 07/14/25 at 2:26 PM revealed P3 had a diagnosis of spasticity post stroke and on 05/05/25 she received botulinum toxin (botox) injections in the neurology department to relieve the spasticity. The Progress Note by Medical Doctor 1 (MD1) dated 05/05/25 at 8:00 AM indicated, “ ...botox procedure note - limb ...Botulinum Toxin injections ... Indication ...spasticity ... Etiology ...stroke ...Interval History ...Worked well. L [left] arm started loving move [sic] ...Informed consent was obtained ...Procedure ...Injection Schedule ...Upper Limb ...Left ...OF NOTE ...In error, the RIGHT arm was injected ...We discussed the potential for temporary weakness in the R [right] arm. Since we kept to total dose of Dysport [botulinum toxin medication] the same, we also significantly decreased the amount of toxin injected into the L [left] arm. We discussed that there may be less optimal results in the L arm due to this ...We kept the LLE [left lower extremity] the same to optimize gait/balance ...” During observation of the neurology department on 07/15/25 at 3:37 PM, MD1 was interviewed. MD1 stated she remembered P3 and the procedure on 05/05/25. MD1 stated they were in this procedure room [where the interview was being conducted] and “She [P3] goes, ‘I’m ready’ and she holds out her right arm [MD1 held out her right arm in demonstration also]. My documentation is on the screen [MD1 gestures to the computer monitor on the desk beside the procedure chair] and I said ‘left’.” MD1 stated P3’s family member was present and Registered Nurse 1 (RN1). She stated they were talking and then she proceeded to inject P3’s right arm and while she was administering the botox injections P3 stated, “Oh, my goodness, it’s my left arm.” MD1 stated P3 apologized to her, but she apologized to P3. MD1 stated, “I obviously should have caught it anyway.” MD1 stated she stopped injecting the right arm and continued injections to the left arm, administering the same daily dose of medication, and she injected the left leg with the usual dose. MD1 stated she instructed P3 she could have weakness to the right arm because she received botox in the absence of spasticity. MD1 stated, “It was clearly just a mistake.” She stated she reported the error and it was presented at the Executive Committee meeting. MD1 stated right after it happened, “on the same day,” she “started doing time outs” intra-procedure and “we now have a form.” MD1 stated the time-outs were pre-procedure before the Provider was in the room but not intra-procedure. She stated now (beginning 05/05/25) the time-outs are intra-procedure (with the Provider present in the procedure room.) In an interview with Registered Nurse (RN1) on 07/15/25 at 3:48 PM, RN1 stated he began working in the neurology department in 12/2024. RN1 confirmed he was in the procedure room on 05/05/25 with MD1 and confirmed MD1 injected botox into the wrong arm. RN1 stated until 05/05/25, the process was, “The Provider would be ready to inject and we didn’t confirm sites we were injecting.” RN1 stated MD1 administered 6-7 injections and P3 “realized it after a while” and said something like “Oh, I think it’s supposed to be the left side.” RN1 printed the patient consent for the procedure on 05/05/25. It was signed by P3 on 06/11/24. Review of the form revealed, “ ...procedure ...Botulinum Toxin Injections for the preoperative diagnosis of spasticity ...” It did not indicate the location the procedure was to be done on. There was a body diagram just to the right of the section that indicated “Botulinum Toxin Injections” with boxes labeled “R [right]” and “L [left].” The boxes were blank and the laterality of the procedure was not indicated. RN1 confirmed the procedure consent did not indicate which location(s) or side(s) of the body (laterality) were to be injected. RN1 confirmed the consent should include the location and laterality of the procedure. The Director of Regulatory Affairs (DRA) confirmed the findings and stated laterality was supposed to be documented on the procedure consent and was not. On 07/15/25 at 4:10 PM, review of the audit log with the DRA and Neurology Lead Nurse, Registered Nurse 2 (RN2) revealed the audits being done did not include auditing of consents to ensure they indicated procedure location(s) and laterality. Review of the RCA and planned interventions on 07/16/25 at 10:08 AM, revealed no plan to educate or audit patient procedure consents in the neurology department for location and laterality. In an interview with the Quality Service Manager (QSM1) on 07/16/25 at 2:33 PM, the RCA was reviewed. QSM1 stated she oversaw the project related to the RCA for the event with P3 on 05/05/25. The RCA indicated the incident was caused by “Failure to follow established timeout process/policy ...Personal performance: wrong side procedure”. Education on time out procedure per policy was completed, a new form initiated and audits were being done. QSM1 confirmed there was no documented evidence of education or corrective measures to ensure written consents for procedures included the location and laterality of the procedure. When asked about location and laterality being identified on the written consent for procedures QSM1 confirmed it was not included in the RCA and stated, “It’s been discussed ... I don’t think we put it in our action plan.” On 07/16/25 at 10:40 AM the hospital policy titled, “Informed Consent and Refusal” dated 04/29/24 revealed, “ ...A patient’s or his/her surrogate decision maker’s consent must be obtained before any procedure or treatment is provided unless an emergency exists ...” The policy did not include the requirement for a written consent to include location and laterality of procedures.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 36779 Based on observation, interview and policy review, the hospital failed to ensure infection prevention interventions were maintained in the Sterile Processing Department (SPD) when one of three SPD Technicians (SPDT’s) did not follow manufacturer’s recommendations for use of detergent in the cleaning of surgical instruments. Findings included: On 04/18/25 at 1:55 PM, SPDT 2 was observed in the decontamination area of the SPD (located at the Consolidated Service Center in Charleston). SPDT 2 was observed to fill the sink with 15 gallons of water (the sink had lines indicating the number of gallons) and pushed the button on the disinfectant detergent dispenser twice. SPDT 2 stated she always pushed it twice. The disinfectant detergent dispensed was measured and was 4.5 ounces. In a concurrent interview, SPDT 2 pointed to the manufacturer’s instructions for use (MFU’s) which were posted by the sink and stated this was the amount she used for the 15 gallon sink of water. The MFU’s indicated 0.5 to 1 ounce of detergent per gallon of water. The CSP Division Director (CSPDD) was present and confirmed in a concurrent interview the MFU’s were 0.5 to 1 ounce of disinfectant detergent per gallon of water. He observed the detergent dispensed and confirmed it was 4.5 ounces and was not according to the MFU’s. He stated they changed companies in December of 2024 and the new company does not come out to calibrate the dispensers regularly like the old company did. On 04/18/25, the policy titled, “Cleaning, High-Level Disinfection, Sterilization and Storage of Patient Care Equipment and Supplies,” dated 07/12/24 was reviewed. The policy indicated, “...All disinfectants and liquid sterilants should be used...according to their IFU [instructions for use] (including...specified use/dilution...)...””