Trident Medical Center

“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 interview and review of patient records, quality improvement documents and policies, the hospital failed to implement measures to prevent recurrence of a retained sponge after a surgical cardiac procedure in the Cardiac Catheterization Laboratory (Cardiac Cath Lab) for one of six patient records reviewed for insertion of an Automatic Implantable Cardioverter Defibrillator (AICD), Patient 8 (P8). Findings included: Cross Reference A286 482.21 Patient Safety”

“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: 36779 Based on record reviews, interviews and policy review, the hospital failed to ensure sponge counts were completed according to hospital policy for four of six patients reviewed for placement of an automated implantble cardioverter defibrillator (AICD) in the Cardiac Catheterization Laboratory (Cardiac Cath Lab), Patient 8 (P8), Patient 9, Patient 10 and Patient 12. P8 experienced a retained surgical sponge on 08/06/25 and had to undergo a second surgical procedure to remove the foreign object. Findings included: Cross Reference A951 482.51 Operating Room Policies”

“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 interview and review of patient records, quality improvement documents and policies, the hospital failed to implement measures to prevent recurrence of a retained sponge after a surgical cardiac procedure in the Cardiac Catheterization Laboratory (Cardiac Cath Lab) for one of six patient records reviewed for insertion of an Automatic Implantable Cardioverter Defibrillator (AICD), Patient 8 (P8). Findings included: Review of P8’s record on 10/17/25 at 9:10 AM revealed P8 was admitted to the Cardiac Cath Lab for insertion of an AICD on 08/06/25. Review of the Discharge Summary dated 08/07/25 revealed, “...Unfortunately, her [P8’s] post-implant chest x-ray revealed a retained sponge and she was taken back to the lab for retrieval...” Review of the Surgical Case Record dated 08/07/25 revealed P8 arrived for the procedure at 1:41 PM and the document indicated, “...PROCEDURE...INSERT BI-VENTRICULAR AICD...08/06/25 1851 [6:51 PM]...PT [patient] REPORTED 7/10 [pain scale with 0 being no pain and 10 being the worst pain] CHEST PAIN AND TIGHTNESS ON INHLALATION...DR [Doctor]...NOTIFIED. HE RECOMMENDED STAT [immediate] CXR [chest x-ray] AND ECHO [echocardiogram - imaging of the heart]. IMAGING OBTAINED AS ORDERED.” Review of the timeline for the procedure revealed at 6:12 PM the section titled “Post Procedure Count” was blank, and the line titled, “Raytecs [name of radiopaque (detectable on x-ray) sponges]” was blank and the line titled, “count performed by” was blank. There was no documentation of a two-person post-procedure sponge count. Review of the second Procedure Note timed 8:04 PM revealed, “...PROCEDURE...Evacuation of retained sponge...A retained sponge was evacuated...” Review of the timeline for the second procedure revealed no documentation of a two-person pre-procedure sponge count. On 10/17/25 at 12:00 PM, Registered Nurse Scrub Technician 1 (RNST1) was interviewed by phone. RNST1 confirmed he/she was the RNST for P8 on 08/06/25 for both procedures. RNST1 described the process and responsibilities of a RNST. RNST1 stated three counts are done of all sharps, needles, and sutures and then the sponges are counted individually. He/she stated there are ten per pack and with those kinds of cases we have 20 sponges so we count out each individual one. He/she stated the counts are done before the procedure starts and he/she tears off the packaging so he/she has a correct count before the case starts, and then another count is done before the surgeon closes “the pocket” and another count after the procedure is over. RNST1 stated, “The scrub tech [RNST] does that and if another person is available with an eye on it and making sure it’s correct...the circulator [nurse]. RNST1 confirmed all three counts were supposed to be two people. The timeline notes of the counts for both procedures on 08/06/25 were read aloud to RNST1. The documentation indicated the post-procedure sponge count for the first procedure was not done. For the second procedure, the pre-procedure sponge count at 8:37 PM indicated 10 Raytecs. There was no documented evidence a RN counted sponges and there was no documented evidence two people counted sponges. Regarding the first procedure, RNST1 stated, “I think I just did not thoroughly enough count the number of gauze. Maybe I just assumed I had two in one and didn’t separate the gauze out.” The Manager of Clinical Informatics (MCI) was present during the interview and confirmed the findings. In an interview with Registered Nurse Monitor 1 (RNM1) on 10/17/25 at 12:18 PM, when asked if the RNST’s count sponges with a second person, he/she stated, “If the circulator [nurse] is there...Sometimes they are doing a conscious sedation so they can’t be there for the actual count.” In a phone interview with RN Circulator 1 (RNC1) on 10/17/25 at 12:43 PM when asked about counting sponges during procedures, RNC1 stated, “The Tech (RNST) does not verify the counts. We don’t have a set in stone routine where somebody is watching the count. There’s nobody in the room watching them do the count, so they just find a good moment to count. There’s no one specifically watching every single gauze being counted. All three counts there is usually just the Tech.” When asked about use of a sponge tree (device used to count sponges), she/he stated, “A sponge tree has never been used. I don’t even know how the sponge tree works...” When asked if she/he received education on the policy indicating a two-person count is required, she/he stated, “No. I don’t even know what the policy is.” Review of P9’s record on 10/21/25 at 10:42 AM revealed P9 was admitted to the Cardiac Cath Lab on 10/06/25. Review of the procedure timeline dated 10/06/25, revealed, “PROCEDURE ...Bi-ventricular ICD Implant.” There was no documented evidence a two-person sponge count was done pre-procedure, pre-closing or post-procedure. In a concurrent review of the record with the MCI, she/he confirmed the findings. Review of P12’s record on 10/21/25 at 10:49 AM revealed P12 was admitted to the Cardiac Cath Lab on 09/08/25. Review of the procedure timeline dated 09/08/25 revealed, “PROCEDURE ...Dual Chamber ICD Implant.” There was no documented evidence a two-person sponge count was done pre-procedure, pre-closing, or post-procedure. In a concurrent review of the record with the MCI, she/he confirmed the findings. Review of P10’s record on 10/21/25 at 11:20 AM revealed P10 was admitted to the Cardiac Cath Lab on 09/04/25. Review of the procedure timeline dated 09/04/25 revealed, “PROCEDURE ...Bi-ventricular ICD Implant.” There was no documented evidence a two-person sponge count was done pre-procedure, pre-closing, or post-procedure. In a concurrent review of the record with the MCI, she/he confirmed the findings. In an interview with Electrophysiology Technician 3 (EPT3) on 10/21/25 at 11:38 AM, she/he confirmed she/he was in the first procedure for P8 on 08/06/25 but she/he “left before the first case ended.” When asked if she/he ever has someone else count sponges with her/him, EPT3 stated, “Whenever someone else is there.” When asked if she/he uses a sponge tree, EPT3 stated, “I have never used a sponge tree.” When asked if she/he ever counts by herself/himself, EPT3 stated, “The only time would be the pre-closing.” In an interview with RN4 on 10/21/25 at 2:05 PM, when asked if there was ever a time when only one person counted sponges, he/she stated, “I think there was one time one person counted and I was not there and they told me there was this and this and this.” When asked if he/she used a sponge tree, RN4 stated, “I don’t use the sponge tree.” On 10/21/25, review of the hospital policy titled, “Sponge, Sharp, and Instrument Count,” last reviewed 06/2024, revealed, “ ...Surgical/Procedure counts should include sponges...Counts should occur audibly, and while items are concurrently viewed during the count procedure by two individuals, one of whom should be a registered nurse circulator, referred to as the circulating nurse...Retained surgical items are preventable “never events” that can be reduced by implementing multidisciplinary system and team interventions...The circulating nurse is responsible for...Counting and recording the sponge...Recording results of the final counts on the operative/procedure record...Sponge...counts shall be performed at the following times...Before the procedure...Before closure of a cavity...Before wound closure begins...At skin closure or end of procedure...Sponge counter bags should be used to collect used sponges. These should be filled from the bottom up and have a solid colored backing so that each sponge can be visualized by the entire surgical team. At the end of the procedure all sponges should be accounted for by placing each sponge in a pocket of the counter bags. This provides a verification that all sponges are accounted for...Documentation of Surgical/Procedural Counts...The names of all persons who participate in the count must appear on the operative/procedure record...The circulator must document the names of all individuals who participated in the count...” On 10/21/25 at 3:15 PM, documentation of any interventions/measures implemented since the incident with P8 on 08/06/25 was requested of the DRC, The Vice President of Quality (VPQ) and the Cardiovascular Director (CD). On 10/21/25 at 3:15 PM, review of the “Cardiac Cath and Electrophysiology Staff Meeting” dated 08/27/25 revealed, “..Accounted supplies used are collected and Verified...Example - Using the surgical count bag for the raytec gauze sponges...Audits will begin of [sic] September to validate compliance...” There was no documented evidence staff were educated on the hospital’s policy for sponge counts requiring two people. In a concurrent interview with the DRC, when asked for documentation of the audits, the DRC stated they were not started. She/he also confirmed the staff meeting document dated 08/27/25 did not indicate sponge counts requiring two people. In an interview with the CD, he/she confirmed no visual audits were done prior to this survey. In an interview with the VPQ at 3:40 PM, she/he confirmed there had been a delay in auditing stating there was a “gap” in that happening.”

“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 record reviews, interviews and policy review, the hospital failed to ensure sponge counts were completed according to hospital policy for four of six patients reviewed for placement of an automated implantble cardioverter defibrillator (AICD) in the Cardiac Catheterization Laboratory (Cardiac Cath Lab), Patient 8 (P8), Patient 9, Patient 10 and Patient 12. P8 experienced a retained surgical sponge on 08/06/25 and had to undergo a second surgical procedure to remove the foreign object. Based on record reviews, interviews and policy review, the hospital failed to ensure sponge counts were completed according to hospital policy for one of six patients reviewed for placement of an automated implantble cardioverter defibrillator (AICD) in the Cardiac Catheterization Laboratory (Cardiac Cath Lab), Patient 8 (P8). P8 experienced a retained surgical sponge and had to undergo a second surgical procedure to remove the foreign object. Findings included: Review of P8’s record on 10/17/25 at 9:10 AM revealed P8 was admitted to the hospital’s Cardiac Cath Lab on 08/06/25 for insertion of an AICD. Review of the Discharge Summary dated 08/07/25 revealed, “...Unfortunately, her [P8’s] post-implant chest x-ray revealed a retained sponge and she was taken back to the lab for retrieval...” Review of the Surgical Case Record dated 08/07/25 revealed P8 arrived for the procedure at 1:41 PM and the document indicated, “...PROCEDURE...INSERT BI-VENTRICULAR AICD...08/06/25 1851 [6:51 PM]...PT [patient] REPORTED 7/10 [pain scale with 0 being no pain and 10 being the worst pain] CHEST PAIN AND TIGHTNESS ON INHLALATION...DR [Doctor]...NOTIFIED. HE RECOMMENDED STAT [immediate] CXR [chest x-ray] AND ECHO [echocardiogram - imaging of the heart]. IMAGING OBTAINED AS ORDERED.” Review of the timeline for the procedure revealed at 6:12 PM the section titled “Post Procedure Count” was blank, and the line titled, “Raytecs [name of radiopaque (visible on x-ray) sponges]” was blank and the line titled, “count performed by” was blank. There was no documentation of a two-person post-procedure sponge count. Review of the second Procedure Note timed 8:04 PM revealed, “...PROCEDURE...Evacuation of retained sponge...A retained sponge was evacuated...” Review of the timeline for the second procedure revealed no documentation of a two-person pre-procedure sponge count. On 10/17/25 at 12:00 PM, Registered Nurse Scrub Technician 1 (RNST1) was interviewed by phone. RNST1 confirmed he/she was the RNST for P8 on 08/06/25 for both procedures. RNST1 described the process and responsibilities of a RNST. RNST1 stated three counts are done of all sharps, needles, and sutures and then the sponges are counted individually. He/she stated there are ten per pack and with those kinds of cases they have 20 sponges so they count out each individual one. He/she stated the counts are done before the procedure starts and he/she tears off the packaging so he/she has a correct count before the case starts, and then another count is done before the surgeon closes “the pocket” and another count after the procedure is over. RNST1 stated, “The scrub tech [RNST] does that and if another person is available with an eye on it and making sure it’s correct ...the circulator [nurse]. RNST1 confirmed all three counts were supposed to be two people. The timeline notes of the counts for both procedures on 08/06/25 were read aloud to RNST1. The documentation indicated the post-procedure sponge count for the first procedure was not done. For the second procedure, the pre-procedure sponge count at 8:37 PM indicated 10 Raytecs but there was no documented evidence a RN counted sponges and there was no documented evidence two people counted sponges. Regarding the first procedure, RNST1 stated, “I think I just did not thoroughly enough count the number of gauze. Maybe I just assumed I had two in one and didn’t separate the gauze out.” The Manager of Clinical Informatics (MCI) was present during the interview and confirmed the findings. In an interview with Registered Nurse Monitor 1 (RNM1) on 10/17/25 at 12:18 PM, when asked if the RNST’s count sponges with a second person, he/she stated, “If the circulator [nurse] is there...Sometimes they are doing a conscious sedation so they can’t be there for the actual count.” In a phone interview with RN Circulator 1 (RNC1) on 10/17/25 at 12:43 PM when asked about counting sponges during procedures, RNC1 stated, “The Tech (RNST) does not verify the counts. We don’t have a set in stone routine where somebody is watching the count. There’s nobody in the room watching them do the count, so they just find a good moment to count. There’s no one specifically watching every single gauze being counted. All three counts there is usually just the Tech.” When asked about use of a sponge tree (device used to count sponges), she/he stated, “A sponge tree has never been used. I don’t even know how the sponge tree works ...” When asked if she/he received education on the policy indicating a two-person count is required, she/he stated, “No. I don’t even know what the policy is.” Review of P9’s record on 10/21/25 at 10:42 AM revealed P9 was admitted to the Cardiac Cath Lab on 10/06/25. Review of the procedure timeline dated 10/06/25, revealed, “PROCEDURE...Bi-ventricular ICD Implant.” There was no documented evidence a two-person sponge count was done pre-procedure, pre-closing or post-procedure. In a concurrent review of the record with the MCI, she/he confirmed the findings. Review of P12’s record on 10/21/25 at 10:49 AM revealed P12 was admitted to the Cardiac Cath Lab on 09/08/25. Review of the procedure timeline dated 09/08/25 revealed, “PROCEDURE ...Dual Chamber ICD Implant.” There was no documented evidence a two-person sponge count was done pre-procedure, pre-closing, or post-procedure. In a concurrent review of the record with the MCI, she/he confirmed the findings. Review of P10’s record on 10/21/25 at 11:20 AM revealed P10 was admitted to the Cardiac Cath Lab on 09/04/25. Review of the procedure timeline dated 09/04/25 revealed, “PROCEDURE ...Bi-ventricular ICD Implant.” There was no documented evidence a two-person sponge count was done pre-procedure, pre-closing, or post-procedure. In a concurrent review of the record with the MCI, she/he confirmed the findings. In an interview with Electrophysiology Technician 1 (EPT1) on 10/21/25 at 11:02 AM, when asked if he/she was taught about the count procedure policy, EPT1 stated he/she did not remember. In an interview with EPT3 on 10/21/25 at 11:38 AM, she/he confirmed she/he was in the first procedure for P8 on 08/06/25 but she/he “left before the first case ended.” When asked if she/he received training on the policy for counting sponges, EPT3 stated she/he did not remember receiving training on the policy. When asked if she/he has someone else count sponges with her/him, EPT3 stated, “Whenever someone else is there.” When asked if she/he uses a sponge tree, EPT3 stated, “I have never used a sponge tree.” When asked if she/he ever counts by herself/himself without a second person verification, EPT3 stated, “The only time would be the pre-closing.” In an interview with EPRN1 on 10/21/25 at 1:11 PM, when asked if he/she received orientation to the specific policy for counting sponges, EPRN1 stated he/she did not remember. In an interview with RN4 on 10/21/25 at 2:05 PM, when asked if there was ever a time when only one person counted sponges, he/she stated, “I think there was one time one person counted and I was not there and they told me there was this and this and this.” When asked if he/she used a sponge tree, RN4 stated, “I don’t use the sponge tree.” On 10/21/25, review of the hospital policy titled, “Sponge, Sharp, and Instrument Count,” last reviewed 06/2024, revealed, “ ...Surgical/Procedure counts should include sponges...Counts should occur audibly, and while items are concurrently viewed during the count procedure by two individuals, one of whom should be a registered nurse circulator, referred to as the circulating nurse...Retained surgical items are preventable “never events” that can be reduced by implementing multidisciplinary system and team interventions...The circulating nurse is responsible for...Counting and recording the sponge...Recording results of the final counts on the operative/procedure record...Sponge...counts shall be performed at the following times...Before the procedure...Before closure of a cavity...Before wound closure begins...At skin closure or end of procedure...Sponge counter bags should be used to collect used sponges. These should be filled from the bottom up and have a solid colored backing so that each sponge can be visualized by the entire surgical team. At the end of the procedure all sponges should be accounted for by placing each sponge in a pocket of the counter bags. This provides a verification that all sponges are accounted for...Documentation of Surgical/Procedural Counts...The names of all persons who participate in the count must appear on the operative/procedure record...The circulator must document the names of all individuals who participated in the count...””