St Mary’s Regional Medical Center

“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: 49750 Based on review of documentation and interviews, the facility failed to ensure an on-call physician would respond and appear in the Emergency Department within a reasonable period of time for one of twenty patient records reviewed (Patient #1). The hospital’s policy, “EMTALA - On Call Policy” last reviewed 10/2020, stated in part; “K. Physician Appearance Requirements 1. If a physician on the on-call list is called by the hospital to provide emergency screening or treatment and either fails or refuses to appear within a reasonable period of time, the hospital and that physician may be in violation of EMTALA as provided for under section 1867(d)(1 )(C) of the Social Security Act. 2. If a physician is listed as on-call and requested to make an in-person appearance to evaluate and treat an individual, that physician must respond in person in a reasonable amount of time. 3. If, as a result of the on-call physician’s failure to respond to an on-call request, the hospital must transfer the individual to another facility for care, the hospital must document on the transfer form the name and address of the physician who refused or failed to appear within a reasonable time, normally within 30 minutes of the time requested to come in to see the individual in the DED (Dedicated Emergency Department). On December 9, 2024 at approximately 4:50 PM the Emergency Department physician documented a call to the On-Call surgeon. The note reported the On-Call surgeon after reviewing the case, “He recommends contacting outside surgical specialists.” The patient record does not indicate the On-Call surgeon made an in-person appearance to evaluate the patient prior to referring to an outside provider. This deficient practice had the likelihood to cause harm in all patients presenting to the ED with serious conditions requiring an evaluation by an On-Call specialist. Refer to Tag A2404”

“ON CALL PHYSICIANS CFR(s): 489.20(r)(2) and 489.24(j)(1-2) §489.20(r)(2) [The hospital (including both the transferring and receiving hospitals), must maintain] a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition. §489.24(j)(1) Each hospital must maintain an on-call list of physicians on its medical staff in a manner that best meets the needs of the hospital’s patients who are receiving services required under this section in accordance with the resources available to the hospital, including the availability of on-call physicians. §489.24(j)(2)(i) The hospital must have written policies and procedures in place to respond to situations in which a particular specialty is not available or the on-call physician cannot respond because of circumstances beyond the physician’s control. §489.24(j)(2)(ii) The hospital must have written policies and procedures in place to provide that emergency services are available to meet the needs of patients with emergency medical conditions if it elects to permit on-call physicians to schedule elective surgery during the time that they are on call or to permit on-call physicians to have simultaneous on-call duties. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to follow their policies and procedures to ensure its on-call physicians fulfilled their on-call duties, and to accept a patient for whom the hospital had the capability and capacity to treat who presented to the Emergency Department (“ED”) with an emergency medical condition (an illness, injury, symptom or condition so serious one should seek care right away to avoid severe harm or serious impairment) for one (1) of twenty (20) patients reviewed (Patient #1). Findings: The “EMTALA - On Call Policy”, last approved in 07/2024, states in part, “Purpose: To establish guidelines for the hospital and its personnel to be prospectively aware of which physicians, including specialists and sub-specialists, are available to provide additional medical evaluation and treatment necessary to stabilize individuals with emergency medical conditions in accordance with the resources available to the hospital as required by the Emergency Medical Treatment and Labor Act (EMTALA), 42 U.S.C., Section 1395 and all Federal regulations and interpretive guidelines promulgated thereunder.” In addition, the policy states, in part, “The hospital must maintain a list of physicians on its medical staff who have privileges at the hospital or if it participates in a community call plan a list of physicians who participate in such plan. Physicians on the list must be available after the initial examination to provide treatment necessary to stabilize individuals with emergency medical conditions (EMC) who are receiving services in accordance with the resources available to the hospital. The cooperation of the hospital’s medical staff members with this policy is vital to the hospital’s success in complying with the on-call provisions of EMTALA. The hospital should make its privileged physicians aware of their legal obligation as reflected in this policy and should take all necessary steps to ensure that physicians perform their obligations as set forth herein.” The “Plan for the Provision of Patient Care, Nurse and Clinical/Ancillary Staffing Plan and Contingency Plan” last revised in 02/2024, states in part, “ Operating Room (“OR”) Scope of Service: This unit provides inpatient and outpatient surgical services to patients ranging from infants (6 months and older) to geriatrics. All services are included with the exception of OB/GYN, neurosurgery, ophthalmology, and plastic surgery. Hours of Service: Regular scheduled hours of operation from 7 AM to 7 PM, Monday-Friday. Elective cases end at approximately 4 PM. Once rooms are dropped down to 2, elective cases are allowed to start based on staffing and expected finish times. All other hours of operation are covered by On Call Coverage. On Call Coverage is from Monday through Friday 7 PM - 7 AM with one team consisting of one nurse and one certified surgical tech, one Anesthesiologist or CRNA. Weekend on call coverage is from 7 AM Saturday to 7 AM Monday and consists of one nurse and one certified surgical tech, one Anesthesiologist or CRNA... .” In addition, the policy also describes the Intensive Care Unit (“ICU”), “Scope of Service: The ICU is a Moderate Mixed Acuity unit with capacity for (11) eleven patients; all rooms are private. The ICU specializes in the care of adult and geriatric patients with complex and/or unstable medical and post-surgical needs. Older adolescents may be admitted when conditions are within the scope of care and services provided. The SMRMC ICU partners with Hicuity Health care to provide telemedicine support for the care, treatment and services of patients meeting Intensive Care Level... Operating Hours: 24/7... .” On Monday, 12/09/2024 at 2:17 PM, per the medical record, Patient #1 arrived at St. Mary’s Regional Medical Center (“SMRMC”) ED with a chief complaint of swelling in groin from a boil. At 2:23 PM, the triage nurse indicated that he/she had an [Emergency Severity Index] of three (3) and documented the following: Patient comes [in] with cyst on left butt cheek and is now on right cheek and swelling has gone to groin now. At 2:34 PM, he/she was brought to a room in the ED and the past medical history indicated Diabetes mellitus, Hyperlipidemia, Hypertension and has smoked a pack of cigarettes per day for thirty (30) years. On 12/09/2024 at 2:49 PM, Patient #1 was provided with a medical screening exam by Doctor #2. He documented the following: [Patient #1] has a history of diabetes mellitus who presents with/for painful swelling of the right inferior buttocks. Patient #1 states initially the symptoms began a few days ago with a painful cyst on the left buttocks. An evaluation was completed a few days prior at an outpatient urgent care and was placed on Bactrim for concern for a developing abscess. Patient #1 stated the cyst on the left buttocks had resolved however there was progressively worsening swelling and pain on the right inferior buttocks. Patient #1 describes subjective fever, chills, dyspnea, fatigue, and malaise. The medical decision making documentation is as follows: Vital signs reviewed. Laboratory and image findings indicated in ED course. The patient’s symptoms and clinical findings are most concerning for cellulitis with abscess. Less likely necrotizing fasciitis. Will obtain CT imaging of the pelvis. Patient was treated initially with fentanyl. Per the medical record, Doctor #2 documented the following on 12/09/2024: - 4:40 PM Radiology indicates concern for necrotizing fasciitis versus Fournier gangrene. I will page our general surgeon on-call, [Doctor #1]; - 4:50 PM [Doctor #1] indicates his concern for the patient being high-risk for poor outcomes and likely to exhibit hemodynamic instability either during or immediately after procedure. He recommends contacting outside surgical specialists; - 5:15 PM Central Maine Medical Center [“CMMC”] general surgeon indicates that the patient is currently hemodynamically stable and he indicates 1st line treatment for necrotizing fasciitis is immediate treatment in OR from surgery. He indicates at this time there is no reason that our facility cannot provide treatment given we have a surgeon on-call; - 5:41 PM, the CT of the pelvis with contrast resulted and described the following: 1. Extensive subcutaneous gas seen within the posterior thigh and gluteal region extending suspicious for a necrotizing infection secondary to gas-forming organism. Fournier’s gangrene may coexist and clinical correlation is advised. 2. Left medial gluteal cleft abscess described above. 3. Incompletely visualized heterogeneous enhancing exophytic left lower pole renal mass highly suspicious for renal cell carcinoma which will require further evaluation with dedicated imaging of the renal beds. 4. Extensive atherosclerotic disease of the distal abdominal aorta with thrombotic occlusion of the left common iliac artery. High grade stenosis seen involving the origin of the right common iliac artery; - 5:45 PM, I provided the CMMC transfer center with [Doctor #1’s] direct phone number for their surgeon to directly speak with ours; and - 6:45 PM, I was informed that the patient was accepted to CMMC general surgery. On 01/27/2025 at 2:31 PM, Doctor #1 was interviewed and he stated the following: - The Emergency Room doctor called me to discuss the CT scan findings, which I reviewed; - I realized that our ICU was closing and I saw his/her past medical history which included diabetes, high blood pressure, etc., which indicated a need for ICU and possibly more surgeries; - I looked at the reading and based on this and his/her prior medical history, without an ICU, we cannot take this patient; - He/She will likely have a surge response; - I did speak with a Central Maine Medical Center surgeon; - They weren’t happy about taking the patient but I explained what was going on and why this patient should go and my concern was that I did not want to transfer an unstable patient; - The CMMC surgeon asked me if I had seen the patient and I said I had not ... I could tell from the CT and the PMH, what would happen and that we don’t have an ICU; - If I was going to take them to the OR, I would come in; and - In regard to the patient, I did feel bad and was concerned about dumping ... However, without an ICU, we could not take the patient. On 01/27/2025 at 8:51 PM, Doctor #2 was interviewed and stated the following: - He stated, in regard to the patient he saw in the ED - I do remember this patient; - The patient appeared well, but the area looked bad; - I explained this patient to Doctor #1 but he was concerned about no ICU and the high risk for this surgery; - He believed it was too risky for our hospital; - I spoke to a surgeon at CMMC, and he told me we could handle this patient and declined the transfer; - I did not want to be in the “middle” so I gave the surgeon [at CMCC] Doctor #1’s phone number so that they could talk, surgeon to surgeon; and - Doctor #1 did not come to see the patient at bedside. On 1/28/25 at 11:00 AM, Doctor #3, was interviewed and indicated the following: - Recently, the Chief of Surgery asked to speak with me and I was told that there would be no more call; - When asked what that meant, he stated there was a hard stop to the OR at 7 PM and no more guidance was given; - I was told “[OR] does not want to start cases after 5 PM”; - There is no protocol [for the new process], and I have met with leadership multiple times to request this, and they stated they are working on it; - I performed the required surgery, for Patient #1 about a month ago, to another patient and he/she is doing great, and that patient did not require the ICU following surgery; - I cannot predict who will need ICU care or not; - We are still on call to the ED and I will go to bedside 80% of the time; - For this case, I would typically come in or go to bedside if on site for this case; - Yes, [since the provision of care has changed] we have received so much pushback when trying to transfer patients; - This change was made very blindly, as we found out one (1) hour before implementation; and - From the receiving facility’s perspective, I can see how they feel we are “patient dumping”. On 01/28/2025 at 2:00 PM, the Chief Medical Officer (“CMO”) was interviewed by phone with the State Agency’s Physician Consultant, related to the care for Patient #1, which revealed the following: - We do not have an ICU or Intermediate Care and that change was effective 12/10/2024 for admitting to ICU; - The other piece is after hours surgery, but we don’t start cases that will end after 7 PM and there are no surgical services from 7 PM Friday to Monday 7 AM; - On the ICU side, we just don’t have it ... if they need critical care, they will have to be transferred; - Our after-hours process is that if a patients arrive in ED and needs surgical assistance, we would have them talk to the on call surgeon to determine what is needed and discuss if it is something we can manage, can it be done in the time frame that we can accommodate; - There are no policies and procedures related to this new process; - The information came to the highest levels a week before about the new changes, with a day surgery platform; - Before that, I had meetings with medical leadership to share more details and include them in the formatting go forward; - This description would be written in the Provision of Services; - I have looked at Patient #1’s record; - My conclusion is that I think it is complicated, presented with possible Fournier’s Gangrene, very complicated, the ED Physician had a conversation with the surgeon who determined he/she needed an outside facility; - The decision making, well, there were a number of points, this happened 12/09/2024, and while the ICU was officially still open, we knew we were not going to have ICU staff after the 10th, for a patient who needed multiple surgical interventions; - The treatment for his/her diagnosis depends on the location, but typically antibiotics, supportive therapy and surgical debridement; - This was not done because we didn’t feel like we could take care of him/her; - There are degrees, but yes, Patient #1 had a life-threatening condition; - Yes, the surgeon, the operating room and the ICU were available at that time; - The hospital had the capability, but there is a high likelihood that [Patient #1] would need care beyond the surgery that you have to provide; and - Yes, we were able to perform all of those treatments and I would agree that surgery, antibiotics and stabilizing fluid is the EMTALA obligation.”

“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: 46424 Based on document reviews and interviews, the Governing Body failed to ensure that the Medical Staff followed the Medical Staff Bylaws for reviewing and documenting practitioner-specific quality and peer review data (A-0048) and failed to ensure that the Medical Staff’s credentialing quality files contained peer review and periodic appraisals (A-0050). Cross Reference: §482.12(a)(4) Approve Medical Staff Bylaws §482.12(a)(6) Ensure the Criteria for Selection Findings: The Governing Body is required to ensure that the Medical Staff follows approved medical staff bylaws. The Governing Body failed to ensure that the Medical Staff followed the Medical Staff Bylaws for reviewing and documenting practitioner-specific quality and peer review data. See A-0048 for details. The Governing Body is required to ensure that the criteria for medical staff selection are individual character, competence, training, experience, and judgment. The Governing Body failed to ensure that the Medical Staff’s credentialing quality files contained peer review and periodic appraisals. See A-0050 for details. The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.”

“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: 46424 Based on document reviews and interviews, the Condition of Participation (COP) for the Medical Staff was not met as evidenced by the hospital’s failure to ensure that the medical Staff operates under bylaws approved by the Governing Body. Cross Reference: §482.22(a)(1) Medical Staff Periodic Appraisals §482.22(a)(2) Medical Staff Credentialing Findings: a. The Medical Staff must periodically conduct appraisals of its members. The hospital provided no evidence that medical staff appraisals are being conducted according to the process documented in the Medical Staff Bylaws. See A-0340 for details. b. Provider candidates who have been recommended by the medical staff and who have been appointed by the Governing Body are subject to all Medical Staff Bylaws, Rules, and Regulations. The hospital failed to provide evidence of medical staff quality review as required in the Medical Staff credentialing process. See A-0341 for details. The cumulative effects of these deficient practices, specifically the failure to provide documented evidence of meaningful case review as specified in the Medical Staff Bylaws for all but two (2) medical staff members in 2024 as well as the lack of documentation of peer review of Physician #1 cited as an example of the medical staff performing quality review, resulted in noncompliance with this Condition of Participation.”

“MEDICAL STAFF - BYLAWS AND RULES CFR(s): 482.12(a)(4) [The governing body must] approve medical staff bylaws and other medical staff rules and regulations. This Standard is not met as evidenced by: 46424 Based on document review and interviews, the hospital failed to follow all steps specified in the Medical Staff Bylaws for re-credentialing and approval of privileges for medical staff including sharing reviewed quality data with the providers. Findings: The hospital failed to provide documented evidence that the Medical Staff performs the following steps in the determination of privileges and reappointment: - Reviews practitioner-specific quality data and performance improvement activities or case review; - Shares this information with medical staff members at least annually; - Reviews peer review, performance improvement, or quality assurance material prior to the process of re-credentialing and approval of privileges. - Maintains this information in the Medical Center’s credential file of the medical staff member. The hospital failed to provide documented evidence that the Medical Staff conducts periodic appraisals of its members. There was no documented evidence that practitioner-specific quality data and performance improvement activities or case review described in the bylaws was being performed, or any peer review, performance improvement, or quality assurance material was reviewed by the Medical Staff prior to the process of re-credentialing and approval of privileges. The St. Mary’s Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part: “7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner’s licensure, education, training, experience, demonstrated professional competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic reappointment or otherwise shall include, but not necessarily be limited to, the following: 7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities, 7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities; 7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member’s participation in the delivery of medical care. This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center’s credential file established for a Medical Staff member or Allied Health Professional.... 11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care.” On 1/17/2025 at 2:10 PM, the Chief Medical Officer (CMO) was interviewed. When asked about peer review, the CMO acknowledged that there is no consistent process for peer review in individual departments, but there is a peer review committee that meets throughout the year to review flagged cases. The CMO also acknowledged that meetings are canceled when there are no cases to review. The CMO provided an example of a physician whose care was subjected to peer review (Physician #1). The survey team requested minutes of this peer review committee, but the hospital was only able to provide minutes of one (1) meeting in 2024 on 10/10/2024, with 2 cases discussed, neither related to Physician #1. A schedule of peer review committee meetings was provided to the survey team showing all meetings in 2024 were canceled except for the 10/10/2024 meeting and a 6/6/2024 meeting for which the hospital failed to provide minutes. On 1/21/2025 at 11:15 AM, a follow-up interview with the CMO and the hospital President was conducted with further discussion of peer review. The CMO described the “first step” as a referral to the Department Chair for first review. The CMO stated that he also reviews cases reported to him. The CMO acknowledged again that many peer review meetings were canceled in 2024. When asked about medical staff quality review, the CMO mentioned Focused Professional Practice Evaluation (FPPE), Ongoing Professional Practice Evaluation (OPPE), National Surgical Quality Improvement Program (NSQIP) certification, and Det Norske Veritas (DNV) Hip & Joint certification. The CMO stated that peer reviews are part of credentialing process but admitted that documentation is “limited” to “email threads” or just direct communication. The CMO acknowledged “But I know if it is not documented, it did not happen.” On 1/22/2025 at 10:40 AM, the Chair of Psychiatry, who is also a member of the Medical Executive Committee and Peer Review Committees and who will be taking over as Interim CMO next month, was interviewed. She was not able to provide information on any more than the 2 peer review committee meetings that took place in 2024. She was not sure what quality/peer information goes into medical staff credentialing quality files and stated, “From my experience, if it is not documented, it did not happen.” The hospital failed to provide evidence of how quality data are used for credentialing and recredentialing or how the medical staff determines a pattern of concern with a medical staff member. On 1/22/2025 at approximately 2:30 PM, the hospital President asked one of the Quality staff to review Ongoing Professional Practice Evaluation (OPPE) data with the survey team. The Data Quality Coordinator provided an example of the Hospitalist OPPE data elements. She reported that these dashboards are updated monthly and put in a ShareFile with secure access to only the respective chief and the Chief Medical Officer (CMO). Staff confirmed at 2:40 PM that there is no evidence that the OPPE data are reviewed prior to reappointment. When asked if OPPE data are reviewed by the CMO at the Medical Executive Committee, the Medical Staff Coordinator assumed it was but could not confirm. On 1/23/2025 at 8:50 AM, the Director of Quality and the Medical Staff Coordinator reviewed the credential file of Physician #1 mentioned by the CMO as having quality issues with the survey team. The Director of Quality stated that she had identified probable quality concerns with the care provided by Physician #1. There was, however, no evidence in the credentials quality file of Physician #1 that any case review was performed by the hospital medical staff which was confirmed by the Director of Quality. On 1/23/2025 at 10:30 AM, the survey team reviewed 3 more credentialing files for medical staff reappointments with the Medical Staff Coordinator and Director of Quality. The survey team asked about any documentation of quality or case review of these practitioners. There was no documented evidence that quality data or case review of these practitioners was reviewed as part of the reappointment process. There was no evidence in minutes of meetings labeled “Medical Executive Committee” or “Medical Executive Committee Peer Review” of any case review or quality review.”

“MEDICAL STAFF - SELECTION CRITERIA CFR(s): 482.12(a)(6) [The governing body must] ensure that criteria for selection are individual character, competence, training, experience, and judgement. This Standard is not met as evidenced by: 46424 Based on document review and interviews, the hospital failed to provide documented evidence that the Medical Staff conducts periodic appraisals of its members. There was no documented evidence that practitioner-specific quality data and performance improvement activities or case review described in the bylaws was being performed or any peer review, performance improvement, or quality assurance material was reviewed by the Medical Staff prior to the process of re-credentialing and approval of privileges. Findings: The St. Mary’s Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part: “7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner’s licensure, education, training, experience, demonstrated professional competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic reappointment or otherwise shall include, but not necessarily be limited to, the following: 7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities, 7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities; 7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member’s participation in the delivery of medical care. This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center’s credential file established for a Medical Staff member or Allied Health Professional ... 11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care.” On 1/22/2025 at 12:55 PM, the Medical Staff Coordinator (an administrative position supporting the Medical Staff office) was interviewed along with the hospital President. The hospital maintains medical staff credential files online. The Medical Staff Coordinator stated that she has does not have access to individual medical staff member quality files. When the survey team asked to review peer review cases, the Medical Staff Coordinator was able to show an on-line list of cases which were reviewed by the Peer Review Committee. Four (4) cases were reviewed in 2024 for a medical staff with 188 active status members. Physician #1 was not among these four (4) peer reviews. In an interview on 1/27/2025 at 2:10 PM, the Chief Medical Officer (CMO) had mentioned Physician #1 having quality issues which led to a peer review. There was no evidence of how quality data are used for credentialing and recredentialing or how the medical staff determines a pattern of concern with a medical staff member. At approximately 2:30 PM on 1/22/2025, the President asked one of the Quality staff to review Ongoing Professional Practice Evaluation (OPPE) data with the survey team. The Data Quality Coordinator provided an example of the Hospitalist OPPE data elements. She reported that these dashboards are updated monthly and put in a ShareFile with secure access to only the respective chief and the Chief Medical Officer (CMO). Staff confirmed at 2:40 PM that there is no evidence that the OPPE data are reviewed prior to reappointment. When asked if OPPE data are reviewed by the CMO at the Medical Executive Committee, the Medical Staff Coordinator assumed it was but could not confirm. On 1/23/2025 at 8:50 AM, the Director of Quality and the Medical Staff Coordinator were interviewed. The credential file of Physician #1 mentioned by the CMO as having quality issues was reviewed. The Director of Quality stated that she had identified probable quality concerns with the care provided by Physician #1. There was, however, no evidence in the credentials quality file of Physician #1 that any case review was performed by the hospital medical staff which was confirmed by the Director of Quality. On 1/23/2025 at 10:30 AM, the survey team reviewed 3 more credentialing files for medical staff reappointments with the Medical Staff Coordinator and Director of Quality. The survey team asked about any documentation of quality or case review of these practitioners. There was no documented evidence that quality data or case review of these practitioners was reviewed as part of the reappointment process. There was no evidence in minutes of meetings labeled “Medical Executive Committee” or “Medical Executive Committee Peer Review” of any case review or quality review. This deficient practice poses a risk to the health and safety of patients served by the hospital.”

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 46424 Based on document review and interviews, the hospital failed to provide documented evidence that the Medical Staff conducts periodic appraisals of its members. There was no documented evidence that practitioner-specific quality data and performance improvement activities or case review described in the bylaws was being performed or any peer review, performance improvement, or quality assurance material was reviewed by the Medical Staff prior to the process of re-credentialing and approval of privileges. Findings: The St. Mary’s Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part: “7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner’s licensure, education, training, experience, demonstrated professional competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic reappointment or otherwise shall include, but not necessarily be limited to, the following: 7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities, 7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities; 7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member’s participation in the delivery of medical care. This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center’s credential file established for a Medical Staff member or Allied Health Professional.... 11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care.” On 1/17/2025 at 2:10 PM, the Chief Medical Officer (CMO) was interviewed. When asked about peer review, the CMO acknowledged that there is no consistent process in individual departments, but there is a peer review committee that meets throughout the year to review flagged cases. The CMO also acknowledged that meetings are canceled when there are no cases to review. The CMO provided an example of a physician whose care was subjected to peer review (Physician #1). The survey team requested minutes of this peer review committee, but the hospital was only able to provide minutes of one (1) meeting in 2024 on 10/10/2024, with 2 cases discussed, neither related to Physician #1. A schedule of peer review committee meetings was provided to the survey team showing all meetings in 2024 were canceled except for the 10/10/2024 meeting and a 6/6/2024 meeting for which the hospital failed to provide minutes. On 1/21/2025 at 11:15 AM, a follow-up interview with the CMO and the hospital President was conducted with further discussion of peer review. The CMO described the “first step” as a referral to the Department Chair for first review. The CMO stated that he also reviews cases reported to him. The CMO acknowledged again that many peer review meetings were canceled in 2024. When asked about medical staff quality review, the CMO mentioned Focused Professional Practice Evaluation (FPPE), Ongoing Professional Practice Evaluation (OPPE), National Surgical Quality Improvement Program (NSQIP) certification, and Det Norske Veritas (DNV) Hip & Joint certification. The CMO stated that peer reviews are part of credentialing process but admitted that documentation is “limited” to “email threads” or just direct communication. The CMO acknowledged “But I know if it is not documented, it did not happen.” On 1/22/2025 at 10:40 AM, the Chair of Psychiatry, who is also a member of the Medical Executive Committee and Peer Review Committees and who will be taking over as Interim CMO next month, was interviewed. She was not able to provide information on any more than the 2 peer review committee meetings that took place in 2024. She was not sure what quality/peer information goes into medical staff credentialing quality files and stated, “From my experience, if it is not documented, it did not happen.””

“MEDICAL STAFF CREDENTIALING CFR(s): 482.22(a)(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This Standard is not met as evidenced by: 46424 Based on record reviews and interviews, the hospital failed to provide documented evidence that the Medical Staff follows the process delineated in its bylaws regarding quality review of members in the reappointment process as well as demonstrating a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to medical staff members. Findings: The St. Mary’s Regional Medical Center Medical Staff, Bylaws, Rules & Regulations, amended and restated on 6/17/2024, state in part: “7.2.2 Bases for Privileges Determinations. Requests for clinical privileges shall be evaluated based on the Practitioner’s licensure, education, training, experience, demonstrated professional competence, judgment, physical and mental health status, references and other relevant information. The bases for privileges determinations to be made in connection with periodic reappointment or otherwise shall include, but not necessarily be limited to, the following: 7.2.2.1 results of practitioner-specific quality assessment and performance improvement activities, 7.2.2.2 review of the records of patients treated in the Medical Center or other healthcare facilities; 7.2.2.3 and review of the records of the Medical Staff which document the evaluation of the member’s participation in the delivery of medical care. This review may also include direct observation of care provided. This information shall be added to and maintained in the Medical Center’s credential file established for a Medical Staff member or Allied Health Professional... 11.4.13 Provide a process which includes, at a minimum on a yearly basis, relevant documented provider-specific clinical performance improvement feedback to each member of the Medical Staff department who participates in patient care.” On 1/22/2025 at 12:55 PM, the Medical Staff Coordinator was interviewed with the hospital President. The hospital maintains medical staff credential files online, and the Medical Staff Coordinator stated that she has does not have access to individual medical staff member quality files. When the survey team asked to review peer review cases, the Medical Staff Coordinator was able to show an on-line list of cases which were reviewed by the Peer Review Committee. Four (4) cases were reviewed in 2024 for a medical staff with 188 active status members. Physician #1 was not among these four (4) peer reviews. There was no evidence of how quality data are used for credentialing and recredentialing or how the medical staff determines a pattern of concern with a medical staff member. At approximately 2:30 PM, the President asked one of the Quality staff to review OPPE data with the survey team. The Data Quality Coordinator provided an example of the Hospitalist OPPE data elements. She reported that these are updated monthly and put in a ShareFile with secure access to only the respective chief and CMO. Staff confirmed at 2:40 PM that there is no evidence that the OPPE data are reviewed at time of reappointment. When asked if OPPE data are reviewed by the CMO at the Medical Executive Committee, the Medical Staff Coordinator assumed it was but could not confirm. On 1/23/2025 at 8:50 AM, the Director of Quality and the Medical Staff Coordinator were interviewed. The credential file of Physician #1 mentioned by the CMO as having quality issues was reviewed. The Director of Quality stated that she had identified probable quality concerns with the care provided by Physician #1. There was, however, no evidence in the credentials quality file of Physician #1 that any case review was performed by the hospital medical staff. On 1/23/2025 at 10:30 AM, the survey team reviewed 3 more credentialing files for medical staff reappointments with the Medical Staff Coordinator and Director of Quality. The survey team asked about any documentation of quality or case review of these practitioners. There was no documented evidence that quality data or case review of these practitioners was reviewed as part of the reappointment process. There was no evidence in minutes of meetings labeled “Medical Executive Committee” or “Medical Executive Committee Peer Review” of any case review or quality review. This deficient practice poses a risk to the health and safety of patients served by the hospital.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 46424 Based on observations and interviews, the hospital failed to maintain all facilities and equipment on the Chemical Dependency Unit (“D4”) to ensure an acceptable level of safety and quality. Findings: The following was observed on: - 3/18/2024 at 1:14 PM, the patient shower in Room 405B was found damp and musty smelling with a black substance on the ceiling and edges of the shower tile. The ventilation fan in the shower was not able to be demonstrated as operable and had a rust-colored substance on the vent. - 3/19/2024 at 12:09 PM, a stain was observed on the ceiling in Room 404. - 3/19/2024 at 12:20 PM, the mattresses in Rooms 406 and 425 were found to have torn covers, preventing them from being cleaned and sanitized. These findings were confirmed with the Behavioral Nurse Manager on 3/19/2024 at 12:50 PM.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 48232 Based on document reviews, interviews, and observations, St. Mary’s Regional Medical Center failed to ensure patients’ right to receive care in a safe setting by failing to ensure that 15-minute checks were being conducted on an 18 bed Inpatient Psychiatric Unit (C4) as evidenced by: Findings: -St Mary’s Regional Medical Center’s policy titled, “Close Observation, SML Behavioral Health,” last revised 12/2022 states in part: “ ...It is the policy of St. Mary’s Regional Medical Center to initiate and provide close observation for patients exhibiting behavior warranting increased supervision ...” And “ ...Type of Close Observation includes, but is not limited to: suicide precautions (SP) behavioral assessment precautions (BA) fall precautions elopement precautions reassurance Frequency: Intermittent Observation: staff checks every 15 minutes ...” -At 12:11 PM on 11/29/2023 an interview was conducted with DIRECTOR OF ADULT BEHAVIORAL SERVICES which revealed the following information: DIRECTOR OF ADULT BEHAVIORAL SERVICES stated the purpose of the 15-minute checks is to, “make sure the patients are alive and breathing.” DIRECTOR OF ADULT BEHAVIORAL SERVICES stated that 15-minute checks are the primary task technicians perform on C4. -A document titled, “Evidence for Tag A0144 Internal Correspondence,” containing email correspondence was reviewed and revealed the following information: “Evidence for Tag A0144 Internal Correspondence,” contains an email sent to DIRECTOR OF ADULT BEHAVIORAL SERVICES at 7:10 PM on 09/09/2023 which reads in part: “...Hey, [DIRECTOR OF ADULT BEHAVIORAL SERVICES], [TECHNICIAN #1] was our only tech on the floor today and we had an admission from C2. It was discovered that this patient did not have 15 minute checks completed for 11 rounds (2.5 hours)...” “Evidence for Tag A0144 Internal Correspondence,” contains an email sent to DIRECTOR OF ADULT BEHAVIORAL SERVICES at 10:55 AM on 11/01/2023 which reads in part: “...The front door to the unit was not shut completely and was noticeably open for a unknown amount of time. When asking [TECHNICIAN #1] if all the pt’s were accounted for and when the last set of rounds took place. Was informed that [he/she] did not do checks for 30 min. As [he/she] took over the CVO [Constant Visual Observation] we have on the floor, so the tech could use the bathroom. Was informed no other techs were on the floor...” “Evidence for Tag A0144 Internal Correspondence,” contains an email sent to DIRECTOR OF ADULT BEHAVIORAL SERVICES at 11:38 AM on 11/29/2023 which reads in part: “...Checks were not done today 11/29/23 for one hour and thirty minutes. When spoken to [TECHNICIAN #1] [he/she] states [he/she] handed checks off for one hour to give a patient a shower. Spoke with the 2 other techs [TECHNICIAN #2 and TECHNICIAN #3], was told [TECHNICIAN #1] did not had off checks to anyone...” -At approximately 11 AM on 11/29/2023 observations were conducted on the Adult Psychiatric Inpatient Unit (C4) which revealed the following: Surveyor observed RN #1 talking with TECHNICIAN #1 who was holding paperwork to do 15-minute safety checks. RN #1 then returned to the nursing station and stated, “[TECHNICIAN #1] is not doing [his/her] 15-minute checks today.” Surveyor observed staff doing 15-minute checks for the next hour. At the end of the hour, Surveyor asked TECHNICIAN #1 if 15-minute checks were missed on his/her current shift. TECHNICIAN #1 confirmed 15-minute checks had been missed from 10am to 11am on 11/29/2023. -At 9:34 AM on 11/29/2023 an interview was conducted with TECHNICIAN #3 which revealed the following information: At 9:35 AM on 11/29/2023 TECHNICIAN #3 made the following statement, “Some of the 15-minute checks are being falsified because there is no way that you can do all of the checks and all of the patient care.””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 48232 Based on document reviews, observations and interviews, St. Mary’s Regional Medical Center failed to ensure that Registered Nurses (“RN”) performed hand hygiene prior to medication administration and/or following patient contact during four (4) out of five (5) observed medication passes. ( #1, #2, #3, #4). Findings: St. Mary’s Regional Medical Center policy titled, “Medication Administration,” last revised 08/2023 states in part: “...Hand hygiene is performed before handling medications...” St. Mary’s Regional Medical Center policy titled, “Hand Hygiene,” last revised 09/2023 states in part: “...Clean hands before and after routine patient care activities, including entering and exiting the patient care environment and after hand-contaminating activities. Clean hands before handling medication or preparing food...” And “...Hand hygiene indications include: 1. Before touching a patient 2. Before clean/aseptic procedure 3. After body fluid exposure 4. After touching a patient 5. After touching the patient’s surroundings (patient care area)...” St. Mary’s Regional Medical Center policy titled, “Standard Precautions, 1016 (was 13.01),” last revised 03/2022 states in part: “...Gloves: a. Wear gloves when touching blood, body fluids, secretions or excretions and contaminated items. Clean gloves are donned before touching mucous membranes and non-intact skin. Change gloves during patient care if the hands will move from a contaminated body site (e.g., perineal area) to a clean body site (e.g., face). b. Remove gloves after contact with a patient and/or surrounding environment (including medical equipment), using proper technique to prevent hand contamination. c. Do hand hygiene immediately after removal of gloves to avoid transfer of microorganisms to other patients or environments. Note that gloves are an adjunct, not a substitute, for hand hygiene. Utility gloves are disinfected for re-use if the integrity is not compromised....” At approximately 9:06 AM on 11/29/2023, during observation of medication pass #1, RN #2 failed to wash or sanitize his/her hands prior to medication administration. RN #2 failed to wash or sanitize his/her hands following medication administration. At approximately 9:10 AM on 11/29/2023, during observation of medication pass #2, RN #3 failed to wash or sanitize his/her hands prior to medication administration. At approximately 9:10 AM on 11/29/2023, following the observation of medication pass #3, RN #3 assisted the patient with getting dressed. RN #3 failed to wash or sanitize his/her hands following patient contact. At approximately 9:30 AM on 11/29/2023, during observation of medication pass #4, RN #4 failed to wash or sanitize his/her hands prior to medication administration. Surveyors observed that the patient had removed their own intravenous catheter (IV), and the IV was on the floor. RN #4 was observed to have picked up the IV catheter and dressing off of the floor without gloves. RN #4 failed to perform hand hygiene after picking up the IV catheter and dressing with his/her bare hands and proceeded to administer medications.”