Self Regional Healthcare

“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: 28883 Based on record review, review of the hospital’s Quality Policy, and interview, the hospital’s Quality program staff failed to implement interventions to prevent recurrence for an adverse event in which a nurse failed to remove sutures as ordered for Patient #1, one of eight patients reviewed having a procedure in the heart catheterization lab that required sutures. The findings included: Cross Refer to A-286 Patient Safety”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 28883 Based on record reviews, interviews, and review of hospital policy, nursing staff failed to ensure sutures had been removed as ordered for Patient #1 and failed to document the removal of sutures from the groin site(s) for Patients #3, #4, #5, #7, #8, #9, and #10, 8 of 8 patients reviewed who had sutures placed. The findings included: Cross Refer to A-398 Supervision of Contract Staff”

“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: 28883 Based on record review, interviews, and policy review, the hospital’s Quality program staff failed to implement interventions to prevent recurrence of an adverse event in which a nurse failed to remove sutures as ordered for Patient #1, one of eight patients reviewed having a procedure that required sutures. The findings included: Record review on 10/13/25 at 12:37 PM revealed Patient #1 had undergone a Watchman procedure on 9/25/24 in the hospital’s heart catheterization (cath) lab where s/he received sutures for hemostasis (control of bleeding) after the procedure. Patient (Pt) #1 had been admitted as an inpatient and transferred to a telemetry monitoring unit, 7 Tower (T) after the procedure. Review of physician orders revealed an order dated 9/25/24 at 12:00 Noon to remove the sutures the next morning (9/26/24) at 6:00 AM. Further review of the record revealed no nursing documentation that showed that the sutures had been removed from both groin sites. A Discharge Summary dated 9/26/24 by a Cardiology Nurse Practitioner did not address whether the stitches had been removed or not. During an interview on 10/13/25 at 2:20 PM, Risk Manager #1 stated that s/he had been notified of the adverse event on 8/25/25 at 1:25 PM when Pt #1 called him/her. According to the Risk Manager, the patient had walked into the cardiology physician practice group office on 8/25/25 complaining of a stitch coming out the left groin; (having had an attempt at the Watchman procedure in August 2024 with sutures placed in the right and left groin areas). Physician #1, the cardiology physician at the office was not able to remove the suture (due to the risk of bleeding and lack of local anesthetic); and had scheduled the patient for the suture removal in the cath lab. The patient had informed the Risk Manager that s/he had removed a suture from the right groin him/herself, about 2 months prior. According to the Risk Manager, s/he had also spoken with Physician #1 who felt that it was best the suture was removed in the cath lab, in case the suture was around a blood vessel. Review of a brief operative note revealed Pt #1 had been admitted on 8/27/25 to have the left groin suture removed. The wound had been inspected for signs of infections, dehiscence, or delayed wound healing. No erythema, drainage, or abnormal findings noted. Local infiltration anesthesia using lidocaine and bupivacaine with the suture removed atraumatically using sterile technique. Minimal bleeding. Hemostasis achieved with gentle pressure. Sterile dressing applied. Pt tolerated procedure well. According to the Risk Manager, the adverse incident had been placed in the hospital’s reporting system by the Practice Manager on 8/26/25. From there it had been passed on to the nurse manager (NM) for 7 Tower, NM #1. NM #1 did follow up with Registered Nurse (RN) #1, who worked the 7 AM- 7 PM shift the day the sutures should have been removed, on 9/26/24. RN #1 could not recall why the sutures had not been removed as ordered. The Risk Manager stated that currently there was no documentation to support completion of the task (suture removal for Pt #1). When asked if they had spoken to the other nurse, RN #2 who had worked the 7 PM- 7 AM shift on 9/25/24 (s/he would have been the nurse to remove the sutures on 9/26/24 at 6:00 AM); the Risk Manager stated they had not spoken with RN #2 as they had assumed that RN #1 was supposed to have taken out the sutures. When asked if any education had been provided for the nursing staff or interventions implemented to prevent recurrence in response to the adverse event for Pt #1, the Risk Manager stated there had been nothing done other than referring the issue to Nurse Manager #1 for follow up since it happened on her/his unit. During an interview on 10/13/25 at 2:45 PM, Nurse Manager #1 stated there had been no documented education for the nursing staff related to this particular incident; but that s/he does do daily huddles with nursing staff and the importance of checking orders to make sure none are left hanging out (undone) has been discussed. During an interview on 10/14/25 at 10:28 AM, the Director of Quality (DQ) and the Assistant Vice President of Nursing Outcomes and Patient Care (AVP) were present. According to the AVP, s/he works with the Director of Quality and if an issue is discovered with nursing services (for example not following physician orders); they address it and put steps into place to correct the issue. According to the AVP, they have different directors that handle different issues and each has different responsibilities; which include the quality measures of falls, infections, and patient experience. Once an adverse event is reported through risk management, it goes to the particular director that handles the issue and it is reviewed there. If it was just an issue on that unit, they may address the issue with the unit or provide a correction for that nurse. According to the AVP, the director that would review the type of incident that Pt #1 experienced is an open position that needs to be filled; and that is why the incident hadn’t been reviewed. No interventions had been put into place to prevent recurrence. According to the AVP, the directors come together and review information, and his/her role as AVP is to give the quality committee an update on where those different committees are at. According to the DQ, they review issues with a few key members of the governing body during the monthly quality meetings, and then higher level issues go to the board. The AVP and DQ verified there had not been any performance improvement actions taken related to the nursing staffs’ failure to remove sutures from Pt #1. Review of the policy provided by the DQ entitled Quality Management System, reviewed 02/2018; revealed the hospital is committed to upholding the highest standard of care as set forth by their vision and mission. Principles of organizational excellence include process improvement. The hospital, through its strategic planning process establishes measurable quality objectives to meet this commitment and evaluates those objectives.”

“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, the nursing staff on 3 units failed to ensure sutures had been removed or that sutures had been documented as removed for eight of eight patients reviewed who had sutures placed and physician orders for removal. Patient #1 did not have sutures removed as ordered prior to discharge in September 2024. Nursing staff failed to document that Patients #3, #4, #5, #7, #8, #9, and #10 had sutures removed as ordered; 8 of 8 patients with orders for suture removal prior to discharge. The findings included: Record review on 10/13/25 at 12:37 PM revealed the hospital admitted Patient (Pt) #1 on 9/25/24 for a Left Atrial Appendage (LAA) closure procedure called the Watchman, with diagnoses including Atrial Fibrillation, History of Atrial Flutter. The Watchman procedure blocks or closes the opening to the LAA to keep blood clots from going into the bloodstream; preventing a stroke in people with atrial fibrillation who are not on blood thinners. Review of the operative note revealed that multiple attempts were made to implant the device with venous access sheaths and/or devices placed in both the right and left groins; and sutures placed in both the right and left groins after removal of the sheaths for hemostasis (control of bleeding). This was verified during an interview on 10/13/25 at 1:10 PM with Nurse Manager #2. Pt #1 had subsequently been admitted as an inpatient and transferred to unit 7 Tower. Review of physician orders revealed an order dated 9/25/24 at 12:00 Noon for bedrest. In the comments section of the order was information to remove the figure of 8 sutures at 6:00 AM the next morning if staying an inpatient. Review of nursing notes and nursing documentation on the flow sheets revealed nothing to indicate the bilateral femoral sutures had been removed. Review of the hospital discharge summary dated 9/26/24 at 10:00 AM revealed Pt #1’s bilateral femoral insertion sites were grossly intact without bleeding or hematoma; and that Pt #1 was stable for discharge. During an interview on 10/15/25 at 7:30 AM, RN #2 reviewed the physician orders to remove the sutures for Pt #1. According to RN #2, the suture removal would have been his/her responsibility. RN #2 could not recall why the sutures had not been removed as ordered. Record review on 10/14/25 at 1:15 PM revealed Pt #3 had been admitted on 10/1/25 for a LAA closure using the Watchman procedure. Review of the operative note revealed the procedure was successful, with a figure of 8 stitch to the right groin. Pt #3 was admitted as an inpatient and transferred to unit 8 Tower after the procedure. Review of physician orders dated 10/1/25 at 10:55 AM revealed information to remove the figure of 8 stitch at 6:00 AM on 10/2/25. Review of nursing notes and nursing documentation on the flowsheets revealed it had not been documented that nursing had removed the figure of 8 stitch as ordered. Review of a Discharge Summary dated 10/2/25 at 10:17 AM by Nurse Practitioner (NP) #1 revealed s/he had documented the figure of eight stitch had been removed from the right groin that morning without incident. There was nothing documented by the nurse who had removed the suture. During an interview on 10/14/25 at 1:20 PM, RN #3 verified the finding. During an interview on 10/14/25 at 2:51 PM, NP #1 stated s/he does not remove the sutures and stated s/he does forewarn the nurses on the unit to remove the sutures prior to coming to see the patient to do the discharge/discharge summary. Record review on 10/14/25 at 1:25 PM revealed Pt #4 had been admitted to 8 Tower on 10/1/25 after having a watchman procedure and a figure of 8 stitch placed in the groin area. Review of physician orders revealed the figure of eight stitch was to be removed on 10/2/25 at 6:00 AM. There was no nursing documentation to indicate which nurse removed the suture and when, or if there were any complications. This was verified by RN #3 during an interview on 10/14/25 at 1:30 PM. A Discharge Summary y NP #1 bdated 10/2/25 at 10:25 AM revealed the figure of eight stitch had been removed from the right groin that morning without incident. During an interview on 10/14/25 at 2:51 PM, NP #1 stated s/he does not remove the sutures and stated s/he does forewarn the nurses on the unit to remove the sutures prior to coming to see the patient to do the discharge/discharge summary. Record review on 10/14/25 at 1:35 PM revealed Pt #5 had been admitted as an inpatient on 9/11/25 after having a watchman procedure and a figure of 8 stitch placed in the right groin. A physician’s order dated 10/1/25 at 12:00 Noon revealed nursing staff were to remove the figure of eight stitch on 10/2/25 at 6:00 AM. There was no nursing documentation to indicate which nurse had removed the suture or when. This was verified by RN #3 during an interview on 10/14/25 at 1:40 PM. A Discharge Summary by NP #1 dated 10/2/25 at 10:22 AM documented that the figure of 8 stitch had been removed from the right groin that morning without incident. During an interview on 10/14/25 at 2:51 PM, NP #1 stated s/he does not remove the sutures and stated s/he does forewarn the nurses on the unit to remove the sutures prior to coming to see the patient to do the discharge/discharge summary. Record review on 10/14/25 at 1:45 PM revealed Pt #7 had been admitted as an inpatient on 9/3/25 after having a watchman procedure and figure of eight stitch placed. Review of physician orders revealed the figure of eight stitch was to be removed by nursing staff on 9/4/25 at 6:00 AM. There was no nursing documentation to indicate which nurse had removed the suture and when. This was verified by RN #3 during an interview on 10/14/25 at 1:50 PM. A Discharge Summary by NP #1 dated 9/4/25 at 8:40 AM revealed the figure of eight stitch had been removed from the right groin that morning without incident. During an interview on 10/14/25 at 2:51 PM, NP #1 stated s/he does not remove the sutures and stated s/he does forewarn the nurses on the unit to remove the sutures prior to coming to see the patient to do the discharge/discharge summary. Record review on 10/14/25 at 1:55 PM revealed Pt #8 had been admitted as an inpatient on 9/3/25 after having a watchman procedure and figure of eight stitch placed. Review of Physician orders dated 9/3/25 at 2:36 PM revealed nursing staff were to remove the figure of eight stitch on 9/4/25 at 6:00 AM. There was no nursing documentation to indicate which nurse had removed the suture and when. This was verified by RN #3 during an interview on 10/14/25 at 2:00 PM. A Discharge Summary by NP #1 dated 9/4/25 at 9:30 AM revealed the figure of eight stitch had been removed from the right groin that morning. During an interview on 10/14/25 at 2:51 PM, NP #1 stated s/he does not remove the sutures and stated s/he does forewarn the nurses on the unit to remove the sutures prior to coming to see the patient to do the discharge/discharge summary. Record review on 10/14/25 at 2:05 PM revealed Pt #9 had been admitted as an inpatient on 9/2/25 after having an ablation procedure (Minimally invasive procedure that uses heat, cold, or lasers to destroy abnormal tissue) for atrial fibrillation and a figure of eight stitch in both groins. Review of physician orders dated 9/2/25 at 1:43 PM revealed the sutures were to be removed by nursing staff the next morning, 9/3/25 at 6:00 AM. There was no nursing documentation to indicate which nurse had removed the stitches and when; or if there had been any complications. The nursing flowsheet did indicate that on 9/3/25 at 3:45 AM there was a suture, and at 6:15 AM documentation revealed a Tegaderm dressing was in place. This was verified by RN #3 during an interview on 10/14/25 at 2:10 PM. A Discharge Summary dated 9/3/25 at 10:12 AM by NP #1 revealed the sutures had been removed that morning. During an interview on 10/14/25 at 2:51 PM, NP #1 stated s/he does not remove the sutures and stated s/he does forewarn the nurses on the unit to remove the sutures prior to coming to see the patient to do the discharge/discharge summary. Record review on 10/14/25 at 2:15 PM revealed Pt #10 had been admitted as an inpatient on 10/13/25 after having an ablation for persistent atrial fibrillation and figure of eight stitch in the right and left groins. Review of physician orders dated 10/13/25 at 3:28 PM revealed the sutures were to be removed by nursing staff the next morning at 6:00 AM. There was no nursing documentation to indicate which nurse had removed the stitches and when. This was verified by RN #3 during an interview on 10/14/25 at 2:20 PM. A Discharge Summary dated 10/14/25 at 12:24 PM revealed the bilateral sutures had been removed that morning prior to discharge. Review of the hospital’s procedure, “Skin suture removal”, Revised February 24, 2025; revealed that documentation with skin suture removal includes: assessment finding to include the incision site appearance with the presence or absence of redness, warmth, swelling, or drainage, date and time of skin suture removal, location, type and number of skin sutures removed, any complications, application of dressing and tolerance of procedure.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 41879 Based on medical record review, hospital policy and procedure review, review of Medical Staff Rules and Regulations, and staff interviews, the hospital failed to ensure a Medical Screening Exam (MSE) had been provided by a Qualified Medical Personnel (QMP) for 9 of 20 patients reviewed who presented to the hospital’s Emergency Department with a medical complaint. (Patients #1, #2, #3, #8, #10, #11, #12, #16, and #18). The findings include: Cross Refer to A2406.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 28883 Based on interviews, record reviews, hospital Medical Staff Bylaws, on-call physician schedule, and review of facility Emergency Medical Treatment and Labor Act (EMTALA) policy, the hospital failed to provide a Qualified Medical Professional (QMP) to do a Medical Screening Exam (MSE) for 9 of 20 patients who presented to the Emergency Care Center (ECC) for an MSE. (Patient #1, #2 , #3, #8, #10, #11, #12, #16, and #18) The findings are: Review on 8/27/24 at 10:08 AM of the hospital’s Medical Staff Bylaws, dated 5/6/24, revealed Appendix B Medical Staff Rules and Regulations, that included information under Emergency Services that stated, “ .... Qualified Medical Person. The following professionals with the documented competency to perform a medical screening examination in the Emergency Department are the following: a. Certified Nurse Midwife to do medical screening examination of obstetrical patients, greater than twenty (20) weeks gestation, who present to the Emergency Department. b. A Registered Nurse who has been certified competent by the Director of Obstetrics, two (2) other Obstetricians and the Director of the Women’s Center to do medical screening examination of obstetrical patients, greater than twenty (20) weeks gestation, who present to the Emergency Department ...”. Nurse Practitioners (NP’s) and Physician Assistants (PA’s) who were working in the Emergency Care Center (ECC) were not listed as qualified to perform a MSE (Medical Screening Exam). 1. Record review on 8/27/24 from 10:20 AM through 2:26 PM revealed the following patients had received a medical screening exam (MSE) from an advanced practice provider (NP (Nurse Practitioner) or PA (Physician Assistant)) that had not been designated by the governing body to be a Qualified Medical Person (QMP) to perform medical screening exams: Patient #1 came to the Emergency Care Center (ECC) on 7/16/24 after a fall with shoulder pain and swelling. The patient received an MSE from Physician Assistant #2. Patient #2 came to the ECC on 7/22/24 with leg swelling. The patient received an MSE from Physician Assistant #3. Patient #3 came to the ECC on 7/19/24 after a fall and Urinary Tract Infection (UTI) The patient received an MSE from Nurse Practitioner #3. Patient #8 came to the ECC on 8/06/24 for groin and flank pain, abdominal pain also noted. The patient received an MSE by Nurse Practitioner #4. Patient # 8 left Against Medial Advice (AMA) and filled out AMA paperwork. Patient #10 came to the ECC on 08/12/24 with pain to the right leg. The patient received an MSE from Physician Assistant #2. 2. Record review on 8/28/24 from 9:18 AM through 12:26 PM revealed the following patients had received a medical screening exam from an advanced practice provider (NP or PA) that had not been designated by the governing body to be a Qualified Medical Person (QMP) to perform medical screening exams: Patient #11 came to the ECC on 5/18/24 for a fall with head laceration. The patient received a MSE from Physician Assistant #1. Patient #12 came to the ECC for a rash on 4/13/24 and received an MSE from Nurse Practitioner #3. Patient #16 came to the ECC on 8/24/24 after a fall. The patient received a MSE from Nurse Practitioners #1 and #2. The patient was transferred to another hospital for a higher level of care. Patient #18 came to the ECC on 6/26/24 for a rabies vaccine. The patient received a MSE from Nurse Practitioner #2. Review on 8/28/24 at 1:17 PM of the Medical Staff Roster provided by the hospital revealed (8) Advanced Practice Providers (APP’s) had been listed under the group Advanced Emergency Physicians. The APP’s were Physician Assistants (PA’s) #1, #2, #3, and #4; and Nurse Practitioners (NP’s) #1, #2, #3, and #4. During an interview on 8/29/24 at 8:05 AM, the ECC Medical Director verified the Medical Staff Bylaws and Rules and Regulations did not list the ECC Physician Assistants (PA’s) or Nurse Practitioners (NP) as QMP’s to perform MSE. The ECC Medical Director stated the APP’s (Advanced Practice Providers) were capable and have been performing MSE’s appropriately, but governing body/medical staff are now working on changing the verbiage in the Medical Staff Bylaws to include the ECC PA’s and NP’s. During an interview on 8/29/24 at 9:30 AM, the ECC Medical Director and ECC Director of Nursing were present. They reviewed the ECC medical records for Patient’s #11, #12, #16, and #18. They verified the record showed the MSE had been conducted by Nurse Practitioners #1, #2, #3; and Physician Assistant #1. 41879”