Mainehealth Maine Medical Center

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure patient privacy during medication administration. This failure led to Patient #5 receiving a subcutaneous injection in their abdomen while seated at a lunch table with, and in full view of, other patients for one (1) out of ten (10) patients reviewed (Patient #5). Findings: The MaineHealth Patient Care Partnership: Understanding Expectations, Rights, and Responsibilities (not dated) handout, states in part, “... What to expect during your hospital stay ... Protection of your privacy ... Patient Rights: You have the right to ... Privacy ... .” On 05/12/2026 at 12:15 PM, two (2) members of the survey team observed patients, including Patient #5, sitting at tables in a day room/lunchroom on the inpatient unit, “P-6,” eating lunch. The two (2) members of the survey team observed Registered Nurse (“RN”) #1 had a computer on wheels and was administering medications to Patient #5, who was sitting with other patients at a table in the day room/lunchroom, while Patient #5 was in full view of the other patients present at the table. Patient #5’s medical record revealed RN #1 administered an injection of insulin lispro subcutaneously in Patient #5’s left lower abdomen on 05/12/2026 at 12:26 PM. On 05/12/2026 at 12:28 PM, RN #1 confirmed that he/she had administered an insulin injection to Patient #5’s left lower abdomen while Patient #5 was at the lunch table.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure that staff reported allegations of abuse per hospital policy for one (1) of ten (10) patients reviewed (Patient #2). Findings: The “Investigation of Alleged Patient Abuse, Neglect, or Exploitation (ANE) by Staff within MaineHealth Facilities” policy, approved on 07/07/2023, states in part, “Report allegations to either APS [Adult Protective Services] or CPS [Child Protective Services]: - APS or CPS should be contacted as soon as becoming aware of the allegation. - MaineHealth encourages mandated reporters to contact APS or CPS directly. i. If this is not possible, Maine law requires that if the mandated reporter does not report themselves but follows institution protocol to have someone else report, that person has to get written notification that the report has been made or report themselves within 24 hours. Consult with LHS Integrated Quality and Safety team for assistance. ii. Adults: Reports regarding abuse, neglect or exploitation must be made immediately by telephone to the department and may require a written follow up report within 48 hours if requested by Adult Protective Services.” On 05/12/2026 at 11:51 AM, the hospital provided the surveyor team with their internal investigation related to Patient #2. This review indicated the following: On 03/26/2026 at 2:13 PM, Registered Nurse (“RN”) #3 sent an email to the nurse manager that RN #4 was allegedly involved in an incident with Patient #2. On 03/27/2026 at 8:20 AM, the nurse manager read the email sent from RN #3 and called Adult Protective Services at 8:35 AM. The alleged event on 03/25/2026 at 1:30 PM was not reported, in accordance with hospital policy, until 03/27/2026 at 8:35 AM, a duration of forty-three (43) hours after the event. On 05/12/2026 at 12:30 PM, the Human Resources Business Partner was interviewed regarding this event and his/her investigation and confirmed the above timeline of events.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(2) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure the hospital’s policy for restraints and seclusion, related to the documenting of less restrictive measures tried before applying restraints, was implemented for two (2) of five (5) restrained patients reviewed (Patient #16 and #20). Findings: The “Southern Region Use of Restraints” policy, last revised on 05/19/2025 states in part, “Least restrictive alternatives should be implemented first. If the alternatives prove to be ineffective. Document on the Non-Violent Non Self destructive flow sheet in the EHR [Electronic Health Record] ... The trained RN [Registered Nurse] documentation at the time of initiation of restraint will document the following on the Violent Self Destructive flow sheet in the EHR a. Assessment of the patient’s behavior leading to restraint b. Less restrictive alternatives considered or used, as appropriate to the situation, and why these alternatives proved ineffective.” On 05/12/2026 at 2:00 PM, five (5) medical records were reviewed with the Clinical Informatics Nurse. This review identified the following: 1. On 03/25/2026 at 4:32 AM, Patient #16 was placed in an elbow immobilizer, however, there was no documented evidence that less restrictive measures were tried before the restraint was applied. 2. On 03/07/2026 at 7:47 PM and 7:48 PM, Patient #20 was provided with chemical restraints, however, there was no documented evidence that less restrictive measures were tried before the restraints. On 05/12/2026, during the review, the Clinical Informatics Nurse confirmed the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the facility failed to ensure the use of restraint or seclusion was in accordance with the provider order for one (1) of five (5) patients reviewed (Patient #19). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “Chemical Restraint: The administration of a medication(s), which is neither a standard treatment for the patient’s medical or psychiatric condition nor a part of the patient’s daily medication regimen and is used for the primary purpose of controlling a patient’s behavior or restricting a patient’s freedom of movement. ... Orders and Initiation: A trained licensed practitioner, trained provider or designee must issue the order to initiate restraint or seclusion.” On 05/12/2026 at 2:00 PM, five (5) patients medical records that were restrained were reviewed with the Clinical Informatics Nurse. Documentation in Patient #19’s record indicated the following: On 02/09/2026 at 6:41 PM, Medical Doctor (“MD”) #1 ordered a physical hold restraint, which was initiated at 6:02 PM and discontinued at 6:03 PM. MD #1 documented in the face to face assessment that, “The clinical plan for the patient is IM [Intramuscular] sedation.” Per the medical record, on 02/09/2026 at 6:03 PM, a chemical restraint [Droperidol 5 mg] was documented as given. There was no documentation of a chemical restraint order for the medication given. Therefore, the requirements for violent restraints were not followed, according to hospital policy. On 05/12/2026, the above finding was confirmed at the time of the review by the Clinical Informatics Specialist.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure the condition of a patient, who was in restraints, was monitored in accordance with hospital policy for three (3) of five (5) patients reviewed (Patient #16, #19 and #20). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “1. The trained RN [Registered Nurse] documentation at the time of initiation of restraint will document the following on the Violent Self Destructive flow sheet in the EHR [Electronic Health Record] a. Assessment of the patient’s behavior leading to restraint b. Less restrictive alternatives considered or used, as appropriate to the situation, and why these alternatives proved ineffective. c. Date, time and type of restraint used. d. Request for a security officer, if circumstances are warranted. e. The patient’s response to the use of restraint. f. Notification and education provided to the patient/family regarding the necessity. 2. The trained RN ongoing documentation will include the following at a minimum of approximately every 15 minutes on the Violent Self Destructive flow sheet in the EHR. 3. Criteria to determine if a restraint meets the requirements. 4. Documentation of the termination of restraint will be documented on the Violent Self Destructive flowsheet in the EHR, and the trained RN must discontinue the order in the electronic documentation system. (Choose “no longer clinically indicated” from dropdown list). The plan of care should be completed.” In addition, it states, “Guidelines: Restraint for Non-Violent, Non-Self-Destructive Behavior ... Ongoing Assessment - Assessment of the patient’s behavior leading to restraint. - Less restrictive alternatives considered or used, as appropriate to the situation, and why these alternatives proved ineffective. - Supporting documentation for need for continued restraint. - Approximately every two hours, the RN will assess and document the following within the EHR: to assess vital signs as ordered approximately every two hours. At a minimum respiratory rate should be assessed if vital signs cannot be obtained. - A patient’s need for toileting, fluid/food, and neurovascular checks to limbs, skin integrity and range of motion must be attended to approximately every two hours while awake, and the documentation should be completed appropriately. - Criteria to determine if a restraint meets the requirements for using non-violent, non-self-destructive restraint. - Behavioral observations of the patient in restraints - Patient care needs If the patient appears to be sleeping, the period between addressing patient’s need for toileting, fluids/foods, neurovascular checks, skin integrity and range of motion cannot exceed 4 hours, and must be documented.” On 05/12/2026 at 2:00 PM, five (5) patients medical records that were restrained were reviewed with the Clinical Informatics Nurse. 1. Documentation in Patient #16’s record indicated the following: On 03/25/2026 at 4:31 AM, Medical Doctor (“MD”) #3 ordered a left and right elbow immobilizer. On 03/25/2026 at 4:32 AM, Registered Nurse (“RN”) #2 documented the initiation of the restraint. RN #2 documented an assessment at 6:32 AM, however, there is no further evidence of Patient #16 was monitored while restrained. Per the restraint flowsheet, the restraint was discontinued on 03/25/2026 at 8:32 PM, a duration of fourteen (14) hours after the last documented assessment. 2. Documentation in Patient #19’s record indicated the following: On 02/09/2026 at 6:41 PM, MD #1 ordered a physical hold restraint, which was initiated at 6:02 PM and discontinued at 6:03 PM. MD #1 documented in the face to face assessment for the physical hold is that, “The clinical plan for the patient is IM [Intramuscular] sedation.” Per the medical record, on 02/09/2026 at 6:03 PM, a chemical restraint [Droperidol 5 mg] was documented as given. There was no restraint flowsheet documentation completed by an RN for this restraint. There was no documented evidence in the medical record that would show that Patient #19 was monitored while being restrained. 3. Documentation in Patient #20’s record indicated the following: On 03/07/2026 at 9:58 PM, MD #2 ordered a chemical restraint. Per the medical record, on 03/07/2026 at 9:47 PM and again at 9:48 PM, a chemical restraint (Haldol 5 mg) was documented as given. There was no restraint flowsheet documentation completed by an RN for this restraint. There was no documented evidence in the medical record that would show that Patient #19 was monitored while being restrained. On 05/12/2026, the above findings were confirmed at the time of the review by the Clinical Informatics Specialist.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(i) When restraint or seclusion is used, there must be documentation in the patient’s medical record of the following: The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure the patient received a face-to-face evaluation by the provider within one (1) hour of initiating a restraint for two (2) of five (5) patients that were restrained (Patient #19 and #20). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “ The trained provider or designee’s initial physical, face-to-face examination must be performed within 1 hour of the patient being placed in restraints. ... Violent, self-destructive behaviors a. Patients in violent, self-destructive restraints or seclusion always require direct observation by a trained staff member. b. Violent, self-destructive (including seclusion) requires a face-to-face assessment, where the trained provider or trained designee must complete an in person, face to face evaluation of the patient within 1 hour from the onset of restraint, even if the restraint has been discontinued, to evaluate: i. the patient’s immediate situation, ii. the patient’s reaction to the intervention, iii. the patient’s medical and behavioral condition and iv. the need to continue or discontinue the restraint.” On 05/12/2026 at 2:00 PM, five (5) patients medical records that were restrained were reviewed with the Clinical Informatics Nurse. 1. Documentation in Patient #19’s record indicated the following: On 02/09/2026 at 6:41 PM, MD #1 ordered a physical hold restraint, which was initiated at 6:02 PM and discontinued at 6:03 PM. MD #1 documented in the face to face assessment that, “The clinical plan for the patient is IM [Intramuscular] sedation.” Per the medical record, on 02/09/2026 at 6:03 PM, a chemical restraint [Droperidol 5 mg] was documented as given. There was no documented evidence that a face-to-face was completed, following the chemical restraint. 2. Documentation in Patient #20’s record indicated the following: On 03/07/2026 at 9:58 PM, MD #2 ordered a chemical restraint. Per the medical record, on 03/07/2026 at 9:47 PM and again at 9:48 PM, a chemical restraint (Haldol 5 mg) was documented as given. There was no documented evidence that a face-to-face was completed, following the chemical restraint. On 05/12/2026, the above findings were confirmed at the time of the review by the Clinical Informatics Specialist.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(4) Training documentation. The hospital must document in the staff personnel records that the training and demonstration of competency were successfully completed. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure that staff member’s personnel record contained documentation of the required training for three (3) of five (5) Providers who had been involved in the restraint of a patient (Medical Doctor (“MD”) #1 and #2, and Physician Assistant (“PA”) #1). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “All staff who are involved with the application of a restraint, implementation of seclusion, providing care for a patient in restraint or seclusion, or assessment and monitoring the condition of the violent self-destructive restrained or secluded patient, will receive training based on their duties and responsibilities. Training occurs prior to performing restraint application and on a periodic basis.” In addition, it states, “A trained licensed practitioner, trained provider or designee must issue the order to initiate restraint or seclusion. ... Apply restraints with a trained team of staff to prevent patient or staff injury.” On 05/12/2026 at 2:00 PM, five (5) patients medical records that were restrained were reviewed with the Clinical Informatics Nurse. On 05/12/2026, the training documentation for five (5) Providers involved in the restraints were requested, which revealed the following: 1. MD #1: On 02/09/2026, MD #1 was involved in the care of Patient #19 when he/she was restrained. On 05/13/2026, MD #1’s training records were reviewed and this indicated that MD #1’s last completed training on restraints was completed on 06/11/2022. As of 05/13/2026, the hospital failed to provide evidence to the surveyor that indicated MD #1 had completed periodic refresher training on restraints since 06/11/2022. 2. MD #2: On 03/07/2026, MD #2 was involved in the care of Patient #20 when he/she was restrained. On 05/13/2026, MD #2’s training records were reviewed, and this indicated the hospital failed to provide evidence that MD #2 had evidence of restraint training. As of 05/13/2026, there was no evidence provided to the surveyor that indicated MD #2 had completed any training on restraints. 3. PA #1: On 04/21/2026, PA #1 was involved in the care of Patient #17 when he/she was restrained. On 05/13/2026, PA #1’s training records were reviewed and this indicated that PA #1 had no evidence of restraint training. As of 05/13/2026, there was no evidence provided to the surveyor that indicated PA #1 had completed any training on restraints. On 05/13/2026 at 2:44 PM, the Accreditation and Compliance Specialist II confirmed that the above Medical Doctor’s and Physician Assistant files failed to contain evidence of restraint training.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure that the medical record contained accurate information for two (2) of twelve (12) patient records reviewed (Patient #11 and #12). Findings: The MaineHealth System-Wide “Record Retention Policy” last reviewed on 12/29/2025 states in part, “The policy defines a record as the following, “A record is recorded information, regardless of medium, that is retrievable. It includes all original documents, papers, letters, xrays, cards, books, maps, photographs, blueprints, sound or video recordings, microfilm, magnetic tape, electronic media (including e-mail with relevant clinical or administrative information), and other information recording media, regardless of physical form or characteristic, that are generated and/or received by MH [MaineHealth] in connection with providing patient care or otherwise transacting its business.” In addition, it states, “It is the policy of MH [MaineHealth] to apply effective and cost efficient management techniques to maintain complete, accurate and high quality records, and to retain records in accordance with applicable federal and state regulations.” On 04/06/2026 and 04/07/2026, twelve (12) medical records were reviewed. This indicated the following: 1) Patient #11 and #12, in 2017, reached out to the patient relations department with concerns that there were many inaccurate entries were noted in the medical records, which later were determined to have been entries added as part of the training with a new electronic health record system that had recently gone “live” at a different MaineHealth Hospital. At that time, when brought to the attention of the hospital, the incorrect information was removed. A flag was added for Patient #11 and #12 to indicate that these were real patients, and the “Break the Glass” [this forces users of the electronic health record to pause and justify accessing a restricted chart, which provided an added layer of security beyond the standard security measures] was implemented at the time for these two (2) patients. 2) Patient #11 and #12, on 01/28/2026, again contacted MaineHealth, as they were notified of lab work that was completed at another hospital within MaineHealth. When looking at the lab work, they knew that these tests did not belong to them and wanted to know why the layer of security placed in 2017 had been breached. 3) MaineHealth discovered, through their investigation, that Patient #11 and #12 had been unknowingly used again as test patients, however, this was done in the “live” records. While validating some lab orders and results for another hospital by [a laboratory] within the electronic health record, these patients record reflected labs that should not have been entered in their record. The layer of security, “Break the Glass”, apparently is not applicable to lab requisitions and/or order entries so there was no safeguard in place for Patient #11 and #12. 4) MaineHealth discovered, through their investigation, that Patient #12 was given access for a test patient for staff training purposes in 2012 and was linked to Patient #12’s MyChart [This is a patient portal app and website that allows individuals to manage their health information, communicate with providers, and access care services via phone, tablet, or personal computer]. Access to test results, medication lists, immunization history, and visit summaries. account. MaineHealth affirms that though this was visible to the patient through MyChart, it was not a part of the true medical record of Patient #12. It is not clear how or why Patient #12 was provided access to the test patient in 2012, but as of 01/29/2026, this access has been removed. On 04/07/2026 at 9:29 AM, an interview was conducted with the Director of Patient Safety and Risk Management, MaineHealth Maine Medical Center. He/She stated that he/she had also been involved in 2017. In May of 2017, [another hospital] went live with the electronic health record software. The Director of Patient Safety and Risk Management first encountered [Patients #11 and #12] in 08/2017. During a Provider visit, and as they were chatting with the doctor it became clear that the information in the record did not match the patients actual medical history. The Director of Patient Safety and Risk Management stated that they identified some [incorrect] “test” information had been included in their charts as staff were training to go live with the new electronic health record software. An analysis of the record and corrections were done at the time. As a protective measure, Director of Patient Safety and Risk Management stated that they added a Break the Glass and a flag for the charts, and it seemed like the issue was corrected. The Director of Patient Safety and Risk Management confirmed that [Patients #11 and #12] labs in [Patients #11 and #12’s] in 2026, should not have been in the record. They involved [a laboratory], and further analysis identified that this was done as part of a testing for the new Epic Beaker system [a comprehensive Laboratory Information System, designed to manage, track, and report lab specimens and results] build in another hospital. It was a staged approach to provide a new module to enter lab orders. This somehow was associated with testing. My understanding is that there is a requirement, attached to CLIA [Clinical Laboratory Improvement Amendments], to test in the production [live] environment to ensure that it was working. The safety mechanism from 2017 was still there but the lab order entry process doesn’t have a Break the Glass safeguard.”

“PROTECTING PATIENT RECORDS CFR(s): 482.24(b)(3) The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure that medical records remained confidential and ensure that unauthorized individuals gained access for two (2) of twelve (12) patient records reviewed (Patient #11 and #12). Findings: The MaineHealth System-Wide “Medical Staff Access to Protected Health Information Policy” last approved on 10/06/2025 states in part, “MaineHealth recognizes the critical importance of protecting patient privacy and ensuring that medical staff have access to the necessary information to provide high-quality are. As 3part of this commitment, the hospital has developed guidelines to govern the use of the Electronic Health Record (EHR) for medical staff, including Trainees (Interns, Residents, and Fellows), Designated Providers (Advanced Practice Providers, Psychologists, and Dentists), and other healthcare providers involved in direct patient care. This policy ensures that PHI is accessed and disclosed only for legitimate purposes related to patient care, continuity of care, and education, and that access is conducted in accordance with the “minimum necessary” standard.” The MaineHealth System-Wide “Use and Disclosure of Protected Health Information Policy” last approved on 11/22/2024 states in part, “This document sets forth the policy of MaineHealth regarding the conditions under which a patient’s Protected Health Information (“PHI”) may be used or disclosed by MAINEHEALTH. ... Access to PHI for Educational Purposes: Although MaineHealth’s general consent to treat form permits the disclosure of patient information to residents and students, the disclosure may be made only to those trainees who are involved in treatment of the patient. The general consent to treat does not authorize disclosure of patient information to those not involved with the patient’s treatment.” The MaineHealth System-Wide “Privacy and Confidentiality Policy” last approved 09/10/2021 states in part, “Individuals who access or control access to Confidential Information, including protected health information (PHI) or electronic personal health information (ePHI) at any MaineHealth must maintain the confidentiality, security, availability and integrity of that Confidential Information, including any technology which supports and protects that information.” The policy defines workforce to include “employees, volunteers, trainees, and other persons whose conduct, in the performance of work for MaineHealth, is under the direct control of that organization, whether or not they are paid by that organization.” The MaineHealth “Guidance on Use of the Patient Level Confidentiality “Break the Glass” Feature” states in part, “The “Break the Glass” (BTG) feature ... is a privacy safeguard designed to restrict access to a patient’s medical record in exceptional situations where there is a legitimate concern about inappropriate or unauthorized access. The BTG function requires users to provide justification and reauthenticate before proceeding with access. This guidance document outlines the limited circumstances in which patient level BTG may be applied, emphasizing that it should only be used in rare and serious cases, such as high-profile patients or those with highly communicable diseases, where there is a legitimate privacy or safety concern. BTG may be used in the following exceptional circumstances: ... 2. When there is a documented safety concern or security risk - This includes situations where there is reason to believe that access to a patient’s medical record could result in harm or unwanted exposure, such as when the safety or wellbeing of the patient, staff, or others is at risk.” On 04/06/2026 and 04/07/2026, twelve (12) medical records were reviewed. This indicated the following: 1) Patient #11 and #12, in 2017, reached out to the patient relations department with concerns that there were many inaccurate entries were noted in the medical records, which later were determined to have been entries added as part of the training with a new electronic health record system that had recently gone “live” at a different MaineHealth Hospital. At that time, when brought to the attention of the hospital, the incorrect information was removed. A flag was added for Patient #11 and #12 to indicate that these were real patients, and the “Break the Glass” [this forces users of the electronic health record to pause and justify accessing a restricted chart, which provided an added layer of security beyond the standard security measures] was implemented at the time for these two (2) patients. 2) Patient #11 and #12, on 01/28/2026, again contacted MaineHealth, as they were notified of lab work that was completed at another hospital within MaineHealth. When looking at the lab work, they knew that these tests did not belong to them and wanted to know why the layer of security placed in 2017 had been breached. 3) MaineHealth discovered, through their investigation, that Patient #11 and #12 had been unknowingly used again as test patients, however, this was done in the “live” records. While validating some lab orders and results for another hospital by [a laboratory] labs within the electronic health record, these patients record reflected labs that should not have been entered in their record. The layer of security, Break the Glass, apparently is not applicable to lab requisitions and/or order entries so there was no safeguard in place for Patient #11 and #12. 4) MaineHealth discovered, through their investigation, that Patient #12 was given access for a test patient for staff training purposes in 2012 and was linked to Patient #12’s MyChart [This is a patient portal app and website that allows individuals to manage their health information, communicate with providers, and access care services via phone, tablet, or personal computer]. Access to test results, medication lists, immunization history, and visit summaries. account. MaineHealth affirms that though this was visible to the patient through MyChart, it was not a part of the true medical record of Patient #12. It is not clear how or why Patient #12 was provided access to the test patient in 2012, but as of 01/29/2026, this access has been removed. On 04/07/2026 at 9:29 AM, an interview was conducted with the Director of Patient Safety and Risk Management, MaineHealth Maine Medical Center. He/She stated that he/she had also been involved in 2017. In May of 2017, [another hospital] went live with the electronic health record software. The Director of Patient Safety and Risk Management first encountered [Patients #11 and #12] in 08/2017. During a Provider visit, and as they were chatting with the doctor it became clear that the information in the record did not match the patients actual medical history. The Director of Patient Safety and Risk Management stated that they identified some [incorrect] “test” information had been included in their charts as staff were training to go live with the new electronic health record software. An analysis of the record and corrections were done at the time. As a protective measure, Director of Patient Safety and Risk Management stated that they added a Break the Glass and a flag for the charts, and it seemed like the issue was corrected. The Director of Patient Safety and Risk Management confirmed that [Patients #11 and #12] labs in [Patients #11 and #12’s] in 2026, should not have been in the record. They involved [a laboratory], and further analysis identified that this was done as part of a testing for the new Epic Beaker system [a comprehensive Laboratory Information System, designed to manage, track, and report lab specimens and results] build in another hospital. It was a staged approach to provide a new module to enter lab orders. This somehow was associated with testing. “My understanding is that there is a requirement, attached to CLIA [Clinical Laboratory Improvement Amendments], to test in the production [live] environment to ensure that it was working. The safety mechanism from 2017 was still there but the lab order entry process doesn’t have a Break the Glass safeguard.””

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, it was determined that the hospital failed to ensure that medical record entries were authentic for the patient and consistent with hospital policies and procedures for two (2) of twelve (12) patient medical records reviewed (Patient #11 and #12). Findings: The MaineHealth System-Wide “Record Retention Policy” last reviewed on 12/29/2025 states in part, “The policy defines a record as the following: A record is recorded information, regardless of medium, that is retrievable. It includes all original documents, papers, letters, xrays, cards, books, maps, photographs, blueprints, sound or video recordings, microfilm, magnetic tape, electronic media (including e-mail with relevant clinical or administrative information), and other information recording media, regardless of physical form or characteristic, that are generated and/or received by MH [MaineHealth] in connection with providing patient care or otherwise transacting its business.” In addition, it states, “It is the policy of MH [MaineHealth] to apply effective and cost efficient management techniques to maintain complete, accurate and high quality records, and to retain records in accordance with applicable federal and state regulations.” The MaineHealth System-Wide “Privacy and Confidentiality Policy” last approved 09/10/2021 states in part, “1.Individuals who access or control access to Confidential Information, including protected health information (PHI) or electronic personal health information (ePHI) at any MaineHealth must maintain the confidentiality, security, availability and integrity of that Confidential Information, including any technology which supports and protects that information. 2. Individuals working for, or on behalf of MaineHealth must perform their work consistent with the Procedures outlined below and follow all systems and facilities policies and standards relevant to their jobs and access.” On 04/06/2026 and 04/07/2026, twelve (12) medical records were reviewed. This indicated the following: 1) Patients #11 and #12, in 2017, reached out to the patient relations department with concerns that there were many inaccurate entries were noted in the medical records, which later were determined to have been entries added as part of the training with a new electronic health record system that had recently gone “live” at a different MaineHealth Hospital. At that time, when brought to the attention of the hospital, the incorrect information was removed. A flag was added for Patients #11 and #12 to indicate that these were real patients, and the “Break the Glass” [this forces users of the electronic health record to pause and justify accessing a restricted chart, which provided an added layer of security beyond the standard security measures] was implemented at the time for these two (2) patients. 2) Patient #11 and #12, on 01/28/2026, again contacted MaineHealth, as they were notified of lab work that was completed at another hospital within MaineHealth. When looking at the lab work, they knew that these tests did not belong to them and wanted to know why the layer of security placed in 2017 had been breached. 3) MaineHealth discovered, through their investigation, that Patient #11 and #12 had been unknowingly used again as test patients, however, this was done in the “live” records. While validating some lab orders and results for another hospital by [a laboratory] labs within the electronic health record, these patients record reflected labs that should not have been entered in their record. The layer of security, Break the Glass, apparently is not applicable to lab requisitions and/or order entries so there was no safeguard in place for Patient #11 and #12. 4) MaineHealth discovered, through their investigation, that Patient #12 was given access for a test patient for staff training purposes in 2012 and was linked to Patient #12’s MyChart [This is a patient portal application and website that allows individuals to manage their health information, communicate with providers, and access care services via phone, tablet, or personal computer]. Access to test results, medication lists, immunization history, and visit summaries. account. MaineHealth affirms that though this was visible to the patient through MyChart, it was not a part of the true medical record of Patient #12. It is not clear how or why Patient #12 was provided access to the test patient in 2012, but as of 01/29/2026, this access has been removed. On 04/07/2026 at 9:29 AM, an interview was conducted with the Director of Patient Safety and Risk Management, MaineHealth Maine Medical Center. He/She stated that he/she had also been involved in 2017. In May of 2017, [another hospital] went live with the electronic health record software. The Director of Patient Safety and Risk Management first encountered [Patient #11 and #12] in 08/2017. During a Provider visit, and as they were chatting with the doctor it became clear that the information in the record did not match the patients actual medical history. The Director of Patient Safety and Risk Management stated that they identified some [incorrect] “test” information had been included in their charts as staff were training to go live with the new electronic health record software. An analysis of the record and corrections were done at the time. As a protective measure, Director of Patient Safety and Risk Management stated that they added a Break the Glass and a flag for the charts, and it seemed like the issue was corrected. The Director of Patient Safety and Risk Management confirmed that [Patient #11 and #12] labs in [Patient #11 and #12’s] in 2026, should not have been in the record. They involved [a laboratory], and further analysis identified that this was done as part of a testing for the new Epic Beaker system [a comprehensive Laboratory Information System, designed to manage, track, and report lab specimens and results] build in another hospital. It was a staged approach to provide a new module to enter lab orders. This somehow was associated with testing. “My understanding is that there is a requirement, attached to CLIA [Clinical Laboratory Improvement Amendments], to test in the production [live] environment to ensure that it was working. The safety mechanism from 2017 was still there but the lab order entry process doesn’t have a Break the Glass safeguard”.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 46424 Based on document reviews and interviews, the hospital failed to ensure orders were written for chemical restraints for one (1) of five (5) restrained patient records reviewed (Patient Restraint #11). Findings: The hospital’s policy “Southern Region Use of Restraints” defines a chemical restraint as “the administration of a medication(s), which is neither a standard treatment for the patient’s medical or psychiatric condition nor a part of the patient’s daily medication regimen and is used for the primary purpose of controlling a patient’s behavior or restricting a patient’s freedom of movement.” The policy also states: “Trained provider or designee must issue the order to initiate restraint. The order must be renewed daily if the criterion for release of the restraint is not met. If anyone other than the attending/covering attending orders restraints, the attending/covering attending must be notified as soon as possible.” Patient Restraint #11’s medical record revealed the following: Physician #3 was involved in the care of the following patient and ordered medications to alter the patient’s behavior. On 02/12/2026 at 3:15 PM, Patient Restraint #11 was administered a one time dose of Droperdiol 5mg (a sedative medication), and physical restraints were applied on 02/12/2026 at 3:24 PM. Patient Restraint #11 then received a one-time does of Versed 4 milligrams (a sedative medication). The medical record indicated the physical restraints were removed at 4:44 PM. On 03/26/2026 at 10:37 AM, the Senior Director reviewed the medical record with the survey team and confirmed that this was a chemical restraint and additionally confirmed there was no written order for a chemical restraint. As of 03/29/2026, the hospital failed to provide evidence that Physician #3 had written an order for a chemical restraint for this patient. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(1) Training intervals. Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion- (i) Before performing any of the actions specified in this paragraph; (ii) As part of orientation; and (iii) Subsequently on a periodic basis consistent with hospital policy. This Standard is not met as evidenced by: 46424 Based on document reviews and interviews, the hospital failed to ensure medical staff, who were involved in patient restraints, had completed the required restraint training for two (2) of five (5) physicians (Physicians #1 and #2). Findings: MaineHealth Maine Medical Center’s “Use of Restraints for Non-Violent/Non Self-Destructive Behaviors” and “Use of Restraints for Violent/Self-Destructive Behaviors” policies both state in part for providers, “Providers ordering restraints will receive restraint education according to medical staff bylaws and the current policy during Medical Staff Orientation with the Quality & Risk Department and/or HealthStream. Restraint training will be provided through HealthStream or face to face with the education department to any caregiver responsible for applying restraints,” and for staff, “On-going training and evaluation for competency of the assessment/reassessment, safe use, application and release occurs annually for all staff who applies restraints.” Physician #1 was involved in the care of the following patient who was restrained: Patient Restraint #1 was in restraints form 02/13/2026 - 02/14/2026. Violent restraints were applied at 2:06 PM on 02/13/2026 and removed on 02/14/2026 at 6:19 AM. The surveyor requested to review the restraint training records of Physician #1. As of 03/26/2026, there was no evidence provided to the surveyor that indicated Physician #1 had completed required training on restraints. Physician #2 was involved in the care of the following patient who was restrained: Patient Restraint #2 was in restraints form 12/03/2025 - 12/03/2025. A physical hold was initiated at 10:45 AM, and then the patient was placed in violent restraints which were applied at 11:05 AM on 12/03/2025 and removed on 12/03/2025 at 12:05 PM. The surveyor requested to review the restraint training records of Physician #2. As of 03/26/2026, there was no evidence provided to the surveyor that indicated Physician #2 had completed required training on restraints. The Senior Director confirmed at 10:33 AM on 03/26/2026 that these two providers had not completed required restraint training.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 46424 Based on document review and interviews, the hospital failed to complete background checks before the first day of employment for one (1) of twelve (12) new hire records reviewed (CNA #1). Findings: Maine State Law under Title 22, Chapter 401: General Provisions §1724, requires hospitals to complete criminal background checks prior to hiring an individual who will work in direct contact with patients. The offer letter to CNA #1 dated 10/2/2025 states in part: “Job offers are contingent upon receipt of documentation that demonstrates your ability to be hired in compliance with employment laws and MaineHealth policies. This includes successful completion of the I-9 (Eligibility to work in the United States), pre-placement Employee Health screening, background investigation, professional licensure verification and credentialing. Your tentative start date is dependent on the completion of these steps.” During the review of new hire records on 1/5/2026, the background check for CNA #1 who started work on 11/3/2015 was not completed until 11/17/2025. This was confirmed by the Manager of Human Resources Operations at the time of the finding, and on 1/6/2025, the Human Resources Advisor confirmed that the background check was not completed before the employee began work at the hospital.”

“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: 50294 Based on document reviews, observations, and interviews, the hospital failed to properly label breast milk while feeding according to hospital policy. The hospital’s policy titled, “Breast Milk Collection, Storage, Administration and Exposure Procedures,” last approved on 6/2023, states in part ... “When pouring the milk into the necessary feeding device/bottle, the nurse will label it with: a. Correct patient’s name and medical record number, b. Date and time of preparation, c. Preparer’s initials.” During a tour of the NICU (Neonatal Intensive Care Unit), it was found that multiple patient’s breast milk were not labeled according to policy. At 10:12AM, room #3746, RN #5 verified that breast milk being administered was without a label. At 10:40AM, room #3863, RN #6 verified that an empty breast milk syringe, which was attached to the baby, was without a label. At 11:00AM, room #3831, RN#7 verified that a breast milk syringe was not labeled properly, missing date, time and preparer’s initials.”

“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 and interviews, the hospital failed to ensure medications were administered in accordance with the providers’ orders for four (4) out of thirteen (13) patient medical records reviewed (Patients #1, #8, #11, & #12). Findings: The hospital’s policy titled, “Administration of Medications,” last approved on 05/22/2023 states in part, “...Medications will be administered only upon the order of providers...” A review of thirteen (13) patients’ medical records was conducted by the survey team on 12/15/2025 at 1:10 PM assisted by Clinical Informatics Specialist #1 and Clinical Informatics Specialist #2 which revealed the following: -A review of Patient #1’s medical record revealed the patient had an order for butalbital-acetaminophen-caffeine 50-325-40 mg tablet ordered as needed for, “ ...headaches ...” The medical record revealed that on 10/23/2025 at 4:57 PM, RN #1 administered a dose of butalbital-acetaminophen-caffeine 50-325-40 mg. RN #1’s documentation indicated that a pain scale of one-to-ten (1-10) was used to assess the patient’s pain at the time of medication administration, however; RN #1 failed to document a pain score on the one-to-ten (1-10) scale. Clinical Informatics Specialist #1 was present for the medical record review and confirmed that no pain score was documented. Clinical Informatics Specialist #1 stated it is an expectation that a nurse would document a pain score. -A review of Patient #8’s medical record revealed the patient had an order for ibuprofen 200 mg tablet as needed for a pain score of one-to-three (1-3.) The medical record revealed that on 08/03/2025 at 6:04 AM ibuprofen 200 mg was administered by RN #2. RN #2’s documentation indicated that a Pain Assessment in Advanced Dementia (“PAINAD”) score was used to assess the patient’s pain at the time of the ibuprofen administration. However, RN #2 failed to document a PAINAD score at this time. Clinical Informatics Specialist #1 was present for the record review and confirmed these findings. -A review of Patient #11’s medical record revealed the patient had an order for Acetaminophen 650 mg as needed for a pain score of one-to-three (1-3). The medical record revealed that on 07/12/2025 at 8:47 PM RN #3 administered 650 mg of acetaminophen to the patient but RN #3 failed to document a pain assessment with a numerical pain score for this administration. Clinical Informatics Specialist #2 was present for the record review and confirmed these findings. -A review of Patient #12’s medical record revealed the patient had an order for oxycodone 5 mg as needed for a pain score of four-to-six (4-6.) The medical record revealed that on 07/19/2025 at 4:16 PM, RN #4 documented the patient had a pain score of eight-out-of-ten (8/10) and the medical record revealed RN #4 administered 5 mg of oxycodone for the pain score of eight-out-of-ten (8/10). Clinical Informatics Specialist #2 confirmed was present for the record review and confirmed these findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(2)(vi) [The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] (vi) Monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation. This Standard is not met as evidenced by: 50294 Based on document review and interviews, the hospital failed to ensure required assessment and documentation were completed related to violent restraint, for one (1) out of five (5) medical charts reviewed. (Patient 3R) Findings: MaineHealth Maine Medical Center Policy titled, “Southern Region Use of Restraints” (last revised 06/17/2025) states in part, “...The trained RN ongoing documentation will include the following at a minimum of approximately every 15 minutes on the Violent Self Destructive flow sheet in the EHR [electronic health record].” The medical record indicated; on 06/22/2025 at [10:26 pm], Patient 3R was placed in 4-point violent restraints. initial assessment completed 06/22/2025 at [10:26 pm]. The hospital failed to document the following required assessments: Respirations, Psychological Status/Behaviors, Circulation/Skin Integrity, Continuous Observation with Close Proximity at all times, Patient’s Dignity, Privacy, and Comfort Maintained, and Progress Towards Release, after the completion of the initial assessment. On 07/08/2025 at 1:10 pm, the Clinical Informatics Specialist confirmed that according to the medical record, Patient 3R was in 4-point restraints, and the documentation/assessment was incomplete.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(2) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure the hospital’s policy for restraints and seclusion, related to the documenting of less restrictive measures tried before applying restraints, was implemented for three (3) of five (5) restrained patients (Patient #2R, #3R and #4R). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “Guidelines: Restraint for Violent, Self-Destructive Behavior/ Seclusion ... The trained RN documentation at the time of initiation of restraint will document the following on the Violent Self Destructive flow sheet in the EHR a. Assessment of the patient’s behavior leading to restraint b. Less restrictive alternatives considered or used, as appropriate to the situation, and why these alternatives proved ineffective.” In addition, it also states “Guidelines: Restraint for Non-Violent, Non-Self-Destructive Behavior ... Assessment of the patient and the circumstances should be completed prior to the application of a restraint, if possible. The assessment must include the following [In part]: · Less restrictive alternatives considered or used, as appropriate to the situation, and why these alternatives proved ineffective. · Least restrictive alternatives should be implemented first. If the alternatives prove to be ineffective. Document on the Non-Violent Non Self destructive flow sheet in the EHR.” On 06/18/2025 from 9:00 AM to 10:00 AM, five (5) patients’ medical records that were restrained were reviewed with the Clinical Informatics Specialist. 1. Documentation in Patient #2R’s record indicated that: - On 03/19/2025 at 2:28 PM, Provider #2 ordered bilateral soft wrist restraints; - On 03/19/2025 at 2:29 PM, Registered Nurse (“RN”) #5 applied bilateral soft wrist restraints; - RN #5 documented that Patient #2R had the restraints discontinued on 03/20/2025 at 8:29 AM; and - There was no documented evidence in the medical record that would show that less restrictive measures were attempted prior to applying the restraints. 2. Documentation in Patient #3R’s record indicated that: - On 03/09/2025 at 2:07 PM, Provider #4 ordered a manual hold; - On 03/09/2025 at 2:13 PM, RN #1 documented in part, “...Order obtained for IM [IntraMuscular] Zyprexa. Permission to give med against objection by spouse ... Security called to assist with giving the injection IM ... 5mg IM Zyprexa given at 1410 [2:10 PM] ... .” - There was no restraint flowsheet documentation completed by an RN; and - There was no documented evidence in the medical record that would show that less restrictive measures were attempted prior to applying the restraints. 3. Documentation in Patient #4R’s record indicated that: - On 05/27/2025 at 3:25 AM, RN #7 documented in part, “... pt [patient] to be placed in restraints and medicated for further eval.” - On 05/27/2025 at 3:34 AM, Provider #5 ordered four-point restraints; - There was no restraint flowsheet documentation completed by an RN; and - There was no documented evidence in the medical record that would show that less restrictive measures were attempted prior to applying the restraints. On 06/18/2025, the above findings were confirmed at the time of the review by the Clinical Informatics Specialist.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the facility failed to ensure the use of restraint or seclusion was in accordance with the provider order for one (1) of five (5) patients reviewed (Patient #3R). Finding: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “Violent, self-destructive behaviors: Assessment for psychological status/behaviors/ circulation/ skin integrity, patients’ dignity, privacy and comfort maintained and progress towards release is assessed and documented approximately every 15 minutes. 4. Non-violent, non-self-destructive behaviors: Assessed for safety and continued need at a minimum of approximately every 2 hours. Assessment includes patient dignity, privacy and comfort maintained, nutrition and hydration, elimination, circulation/ skin integrity, range of motion and progress towards release. 5. Violent, self-destructive behaviors a. Patients in violent, self-destructive restraints or seclusion always require direct observation by a trained staff member. b. Violent, self-destructive (including seclusion) requires a face-to-face assessment, where the trained provider or trained designee must complete an in person, face to face evaluation of the patient within 1 hour from the onset of restraint, even if the restraint has been discontinued, to evaluate: i. the patient’s immediate situation, ii. the patient’s reaction to the intervention, iii. the patient’s medical and behavioral condition and iv. the need to continue or discontinue the restraint. c. Consultation with the Attending/covering Attending should occur as soon as possible and include: i. a discussion of the findings of the 1-hour face to face evaluation ii. the need for other interventions or treatments, and iii. the need to continue or discontinue the use of restraint or seclusion.” On 06/18/2025 from 9:00 AM to 10:00 AM, five (5) patients’ medical records that were restrained were reviewed with the Clinical Informatics Specialist. 1. Documentation in Patient #3R’s record indicated that: - On 03/01/2025 from 10:22 AM, Provider #6 ordered non-violent restraint soft bilateral wrist restraints was ordered; - On 03/01/2025 from 10:22 AM through 10:45 AM, Registered Nurse (“RN”) #2 documented on the restraint flowsheet that soft bilateral wrist restraints were applied; - On 03/01/2025 at 10:45 AM, RN #2 documented, “Temporary restraints for combative behavior, were not ordered as violent, discontinued approx.. 20 min once behavior improved”; - Based on the above, the intent of the restraint type, per the nursing documentation, did not match the order by the provider; - There was no documented evidence that a violent restraint was ordered on 03/01/2025 for Patient #3R; and - Therefore, the requirements for violent restraints were not followed, per hospital policy. On 06/18/2025 from 9:00 AM to 10:00 AM, the above findings were confirmed at the time of the review by the Clinical Informatics Specialist.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure a restraint was discontinued at the earliest time possible for two (2) of five (5) patients (Patient #1R and #3R). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “Guidelines: Restraint for Violent, Self-Destructive Behavior/ Seclusion ... Documentation of the termination of restraint will be documented on the Violent Self Destructive flowsheet in the EHR, and the trained RN must discontinue the order in the electronic documentation system. (Choose “no longer clinically indicated” from dropdown list). The plan of care should be completed.” On 06/18/2025 from 9:00 AM to 10:00 AM, five (5) patients’ medical records that were restrained were reviewed with the Clinical Informatics Specialist. 1. Documentation in Patient #1R’s record indicated that: - On 02/04/2025 at 1:02 AM, Registered Nurse (“RN”) #6 applied four-point restraints; - On 02/04/2025 at 1:43 AM, Provider #1 ordered four-point restraints; - On 02/04/2025 at 8:45 AM, RN #6 documented that “no progress” had been made towards the release of the four-point restraints with no further documentation; and therefore, - It could not be determined if the restraint was discontinued at the earliest possible time. 2. Documentation in Patient #3R’s record indicated that: - On 03/09/2025 at 2:07 PM, Provider #4 ordered a manual hold; - On 03/09/2025 at 2:13 PM, RN #1 documented in part, “...Order obtained for IM [IntraMuscular] Zyprexa. Permission to give med against objection by spouse ... Security called to assist with giving the injection IM ... 5mg IM Zyprexa given at 1410 [2:10 PM] ... .” - There was no restraint flowsheet documentation completed by an RN; and - Therefore, it could not be determined if the restraint was discontinued at the earliest possible time. On 06/18/2025, the above findings were confirmed at the time of the review by the Clinical Informatics Specialist.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 42601 REPEAT DEFICIENCY Based on document reviews and interviews, the hospital failed to ensure the condition of a patient, who was in restraints, was monitored in accordance with hospital policy for two (2) of five (5) patients reviewed (Patient #3R and #4R). Findings: During a recent complaint survey on 04/07/2025, the hospital was in substantial compliance with 42 Code of Federal Regulations, Part 482, Conditions of Participation: Patient Rights (§482.13). However, there was a following standard level requirement that was not met. Based on document reviews and interviews, the hospital failed to ensure the condition of a patient, who was in restraints, was monitored every two (2) hours in accordance with hospital policy for one (1) of five (5) patients reviewed (Patient #4R). On 4/07/2025 at approximately 1:00 PM, Patient 4R’s medical record was reviewed with the Clinical Informatics Specialist. This review indicated the following: - On 2/12/2025 at 11:00 PM, Patient #4 had soft bilateral wrist restraints applied; - On 2/16/2025 from 2:37 PM until 8:57 PM (a duration of five (5) hours and twenty (20) minutes), there was no documentated evidence of the required monitoring; and - On 2/17/2025 at 6:49 PM, the restraints were discontinued. On 4/07/2025 at approximately 1:00 PM, this finding was confirmed by the Clinical Informatics Specialist at the time of the review. The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “1. The trained RN documentation at the time of initiation of restraint will document the following on the Violent Self Destructive flow sheet in the EHR a. Assessment of the patient’s behavior leading to restraint b. Less restrictive alternatives considered or used, as appropriate to the situation, and why these alternatives proved ineffective. c. Date, time and type of restraint used. d. Request for a security officer, if circumstances are warranted. e. The patient’s response to the use of restraint. f. Notification and education provided to the patient/family regarding the necessity. 2. The trained RN ongoing documentation will include the following at a minimum of approximately every 15 minutes on the Violent Self Destructive flow sheet in the EHR. 3. Criteria to determine if a restraint meets the requirements. 4. Documentation of the termination of restraint will be documented on the Violent Self Destructive flowsheet in the EHR, and the trained RN must discontinue the order in the electronic documentation system. (Choose “no longer clinically indicated” from dropdown list). The plan of care should be completed.” In addition, it states, “Holding a patient in a manner that restricts the patient’s freedom of movement against the patient’s will is considered a violent/self-destructive restraint. An example is the application of force to physically hold a patient, to administer a medication against the patient’s wishes, is considered a restraint. This intervention should be a temporary measure; if a longer hold is necessary, alternative restraint types should be considered.” On 06/18/2025 from 9:00 AM to 10:00 AM, five (5) patients’ medical records that were restrained were reviewed with the Clinical Informatics Specialist. 1. Documentation in Patient #3R’s record indicated that: - On 03/09/2025 at 2:07 PM, Provider #4 ordered a manual hold; - On 03/09/2025 at 2:13 PM, Registered Nurse (“RN”) #1 documented in part, “...Order obtained for IM [IntraMuscular] Zyprexa. Permission to give med against objection by spouse ... Security called to assist with giving the injection IM ... 5mg IM Zyprexa given at 1410 [2:10 PM] ... .” - There was no restraint flowsheet documentation completed by an RN; and - There was no documented evidence in the medical record that would show that the patient was monitured while being restrained. 2. Documentation in Patient #4R’s record indicated that: - On 05/27/2025 at 3:25 AM, RN #7 documented in part, “... pt [patient] to be placed in restraints and medicated for further eval.” - On 05/27/2025 at 3:34 AM, Provider #5 ordered four-point restraints; - There was no restraint flowsheet documentation completed by an RN ; and - There was no documented evidence in the medical record that would show that the patient was monitured while being restrained. On 06/18/2025, the above findings were confirmed at the time of the review by the Clinical Informatics Specialist.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(1) Training intervals. Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion- (i) Before performing any of the actions specified in this paragraph; (ii) As part of orientation; and (iii) Subsequently on a periodic basis consistent with hospital policy. This Standard is not met as evidenced by: 42601 Based on document reviews and interviewed, the hospital failed to ensure that staff ordering and applying restraints had the required training per hospital policy for two (2) Registered Nurses (“RNs”) and one (1) Provider involved in the ordering and applying of restraints (RN #4, RN #5 and Provider #6). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “All staff who are involved with the application of a restraint, implementation of seclusion, providing care for a patient in restraint or seclusion, or assessment and monitoring the condition of the violent self-destructive restrained or secluded patient, will receive training based on their duties and responsibilities. Training occurs prior to performing restraint application and on a periodic basis.” In addition, it states, “A trained licensed practitioner, trained provider or designee must issue the order to initiate restraint or seclusion. ... Apply restraints with a trained team of staff to prevent patient or staff injury.” On 06/18/2025 from 9:00 AM to 10:00 AM, five (5) patients’ medical records that were restrained were reviewed with the Clinical Informatics Specialist. The following was identified: 1. Documentation in Patient #2R’s record indicated that: - On 03/08/2025 at 4:34 AM, RN #5 applied bilateral soft limb restraints; and - RN #5 had restraint training on 09/16/2021. Based on the above finding, RN #5 did not meet the requirements to be involved with the restraint of Patient #2R. 2. Documentation in Patient #2R’s record indicated that: - On 03/12/2025 at 10:15 AM, RN #4 was involved with the discontinuation of restraints; and - RN #4 last had restraint training on 01/17/2022, upon hire. Based on the above finding, RN #4 did not meet the requirements to be involved with the restraint of Patient #2R. 3. Documentation in Patient #3R’s record indicated that: - On 03/01/2025 at 10:22 AM, Provider #6 ordered restraints; and - Provider #6 had no documented training prior to 03/05/2025. Based on the above finding, Provider #6 did not meet the requirements to be involved with the restraint of Patient #3R. On 06/18/2025 at approximately 1:30 PM, the Senior Director, Regional Accreditation and Regulatory Affairs confirmed the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(4) Training documentation. The hospital must document in the staff personnel records that the training and demonstration of competency were successfully completed. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure that staff member’s personnel record contained documentation of the required training for three (3) of sixteen (16) staff who had been involved in the restraint of a patient (Registered Nurse (“RN”) #4, RN #5 and Provider #4). Findings: The “Southern Region Use of Restraints” policy, last revised 05/19/2025, states in part, “All staff who are involved with the application of a restraint, implementation of seclusion, providing care for a patient in restraint or seclusion, or assessment and monitoring the condition of the violent self-destructive restrained or secluded patient, will receive training based on their duties and responsibilities. Training occurs prior to performing restraint application and on a periodic basis.” In addition, it states, “A trained licensed practitioner, trained provider or designee must issue the order to initiate restraint or seclusion. ... Apply restraints with a trained team of staff to prevent patient or staff injury.” 1. RN #4: - On 03/12/2025, RN #4 was involved in the care of Patient #2R when he/she was restrained; - On 06/18/2025, RN #4’s training records were reviewed and indicated that RN #4 had completed training on restraints on 01/17/2022; and - As of 06/18/2025, there was no evidence provided to the surveyor that indicated RN #4 had completed training on restraints since 01/17/2022. 2. RN #5: - On 03/08/2025, RN #5 was involved in the care of Patient #2R when he/she was restrained; - On 06/18/2025, RN #5’s training records were reviewed and indicated that RN #5 had completed training on restraints on 09/16/2021; and - As of 06/18/2025, there was no evidence provided to the surveyor that indicated RN #5 had completed training on restraints since 09/16/2021. 3. Provider #6: - On 03/01/2025, Provider #6 ordered restraints for Patient #3R; - On 06/18/2025, Provider #6’s training records were reviewed and indicated that Provider #6 had completed training on restraints on restraints on 03/05/2025, four (4) days after ordering restraints; and - As of 06/18/2025, there was no evidence provided to the surveyor that indicated Provider #6 had completed training on restraints prior to 03/05/2025. On 06/18/2025 at approximately 1:30 PM, the Senior Director, Regional Accreditation and Regulatory Affairs confirmed the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to ensure the condition of a patient, who was in restraints, was monitored every two (2) hours in accordance with hospital policy for one (1) of five (5) patients reviewed (Patient #4R). Findings: The hospital’s “Use of Restraints Policy Summary”, last reviewed 8/23/2024, states, in part, “...Approximately every two hours, the RN will assess and document the following within the EHR: - Assess vital signs as ordered approximately every two hours. At a minimum respiratory rate should be assessed if vital signs cannot be obtained. - A patient’s need for toileting, fluid/food, and neurovascular checks to limbs, skin integrity and range of motion must be attended to approximately every two hours while awake, and the documentation should be completed appropriately. - Criteria to determine if a restraint meets the requirements for using non-violent, non-self-destructive restraint. - Behavioral observations of the patient in restraints. - Patient care needs. If the patient appears to be sleeping; the period between addressing patient’s need for toileting, fluids/foods, neurovascular checks, skin integrity and range of motion cannot exceed 4 hours; and must be documented.” On 4/07/2025 at approximately 1:00 PM, Patient 4R’s medical record was reviewed with the Clinical Informatics Specialist. This review indicated the following: - On 2/12/2025 at 11:00 PM, Patient #4 had soft bilateral wrist restraints applied; - On 2/16/2025 from 2:37 PM until 8:57 PM (a duration of five (5) hours and twenty (20) minutes), there was no documentated evidence of the required monitoring; and - On 2/17/2025 at 6:49 PM, the restraints were discontinued. On 4/07/2025 at approximately 1:00 PM, this finding was confirmed by the Clinical Informatics Specialist at the time of the review.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 48232 Based on document reviews and interviews, the hospital failed to ensure restraints were removed or that the restraint order was renewed upon its expiration for (1) out of five (5) restrained patient records reviewed (Patient #12) This failure led to Patient #12 spending over twenty-four (24) hours in restraints without a provider’s order. Findings: MaineHealth’s Southern Region Policy titled, “Use of Restraints,” (no date) states in part, “...The order for nonviolent non self-destructive restraint must be renewed daily if criteria for release of non-violent, non-self-destructive are not met...” On 11/25/2024 at 1:15 PM, Patient #12’s medical record was reviewed with the assistance of the Clinical Informatics Specialist. Patient #12’s medical record revealed the following: -An order for left and right wrist soft limb restraints ordered by Provider #1 and dated 11/22/2024 at 12:48 AM. -Restraint flowsheet documentation indicating that Patient #12 was in left and right wrist soft limb restraints for the entirety of 11/22/2024, 11/23/2024, and 11/24/2024. -An order for left and right wrist soft limb restraints ordered by Provider #2 dated 11/24/2024 at 2:47 PM. Patient #12’s medical record did not reveal an order for left and right wrist soft limb restraints for the time between the expiration of Provider #1’s 11/22/2024 restraint order, and the initiation of Provider #2’s 11/24/2024 restraint order. The Clinical Informatics Specialist confirmed that, according to the medical record, Patient #12 was in restraints without an order from 11/23/2024 at approximately 12 AM until 11/24/2024 at 2:27 PM.”

“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: 50294 Based on document reviews and interviews, the hospital failed to ensure that medications were reconciled for one (1) out of (1) outpatient clinic patients reviewed (Patient #3). Findings: The MaineHealth “Medication Reconciliation” policy (not dated) states in part, “A complete list of a patient’s current medications, allergies and sensitivities will be obtained and documented at all relevant encounters and sites of care... The medication history is completed at all visits whenever medications are administered, prescribed or included in the care or service provided... The patient’s current medication history will be completed using all available resources including the patient, families, caregivers, residential facility, pharmacies and providers...” On 09/24/2024 at 2:30 PM, medical records were reviewed with the Clinical Informatics Specialist. This review revealed the following: -Patient #3’s medical record contained no documented evidence that a medication history was obtained at an outpatient clinic visit on 6/25/2024. On 09/26/2024 at 9:28 AM, the Senior Director of Accreditation confirmed that Patient #3’s medical record visit to the outpatient clinic on 06/25/2024 had no documentation of a medication reconciliation completed as required by hospital policy.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 50294 Based on documentation reviews and interviews, the hospital failed to ensure that the medical record contained accurate information for one (1) out of eleven (11) reviewed patients (Patient #3). Findings: MaineHealth “Documentation Standards for the Legal Health Record” Corporate policy, dated 05/2023 states in part, “When an error is made in a medical record entry, proper error correction procedures must be followed... ...For Electronic Medical Records: When correcting or making a change, the original entry should be viewable, the current date and time should be entered, the person making the change should be identified, and the reason should be noted. In situations where there is a hard copy printed from the electronic record, the hard copy must also be corrected... ...Electronic Documentation: the medical record should only contain documentation that pertains directly to the patient.” On 09/24/2024 at 2:30PM, medical records were reviewed with the Clinical Informatics Specialist. This review revealed the following: -Patient #3 and Patient #11’s had the same first and last name; -Patient #11’s medications, allergies, encounters from outside facilities and medical history was included in Patient #3’s medical record; and -The electronic medical record was not consistent with the hard (printed) copy of Patient #3’s medical record. On 09/25/2024 at 2:30pm, an interview was conducted with the Health Information Manager. She/He believed the problem, after investigating the concern, was from the information network that may have merged Patient #3 and #11’s medical record. On 09/26/2024 at 9:28 AM, an interview was conducted with the Senior Director of Accreditation. She/he stated that upon further review, it was identified that a staff member had uploaded medical information into the incorrect patient’s chart and there was no network error. In addition, corrected information in the electronic and hard copy record were not completed in accordance with the policy until after the date of the initiation of the survey (09/24/2024).”

“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: 48232 Based on document reviews, interviews, and observations, the hospital failed to ensure Sterile Processing Department (SPD) staff performed Ultrasonic Cleaning, a required step of the sterilization process, in one (1) out of two (2) observed Sterile Processing Departments (Portland). Findings: The STERIS InnoWave Unity and Unity 20 Sonic Irrigators (Ultrasonic Cleaner used in the Portland Location) Manufacturer Operator Manual states in part, “... Intended Purpose of Equipment The STERIS InnoWave (Trademark) Unity Sonic Irrigator is designed to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. Cleaning is achieved through a combination of ultrasonic cavitation and low- frequency cannulated pulse enhancement (CPE) fluid recirculation to dislodge and flush away unwanted debris from both the outside and inside surfaces (hollow instruments only) of items placed in the tank...” Maine Medical Center, Bramhall Campus’s Standard Operating Procedure titled, “Sterile Processing Department, Maine Medical Center, Bramhall Campus Job Tools: Standard Operating Procedures (SOP) - Decontamination,” states in part,”...Unless an item is incompatible, all trays must be placed in the ultrasonic cleaner...” On 09/25/2024 at 11:17 AM, Sterile Processing Staff #1 stated the following: - They feel like things are rushed; - They must perform ultrasonic cleaning on very heavily contaminated trays; - A lot of people skip the ultrasonic cleaning process; and - The ultrasonic cleaning step is very important for patient safety. On 09/25/2024 at 11:33 AM, Sterile Processing Staff #2 stated the following: - To “ultrasonic something” means putting the equipment to be sterilized into a machine that makes ultrasonic cavitation bubbles, or vibration, to remove contamination; - There are staff that skip the ultrasonic step; - The equipment needs to go into the ultrasonic because that was the process. On 09/25/2024 at 12:17 PM, Sterile Processing Staff #3 stated the following: - We recently had five (5) trays sent back because they found adhesive or bioburden (viable microorganisms); - Most of the time it is the same people who are just more or less dunking their trays in, doing a quick inspection and just sending it through the wash; - Some trays that are really needed, and they can’t be sent through sterilization because they are dirty so they must get sent back to the staff in the sink area, which takes more time; - I have complained before and [the management of the Sterile Processing Department] says they will take care of it; however - We are still seeing dirty trays. On 09/26/2024 at 10:33 AM, Sterile Processing Staff #4 stated the following: - If I received a tray in [decontamination] that was clearly not used in surgery, I have been told that it was alright if I just took [the tray] apart and manually cleaned it; and - I wouldn’t put it in the ultrasonic cleaner. On 09/26/2024 at 10:48 AM, the SPD Educator, also known as the Central Services Educator, stated the following: - Unless the item would be damaged by going through an ultrasonic machine, this would be a mandatory step according to the standard operating procedures; and - To his/her knowledge, this step in the process is happening. On 9/26/2024 at 1:30 PM, these findings were reviewed with hospital leadership.”

“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: 30938 Based on review of documentation and interviews, the facility failed to ensure patients presenting to the Emergency department (ED) with suicidal risk received an appropriate medical screening exam prior to being discharged and escorted out of the hospital by police. In 1 of 20 sampled patients (Patient #5). An EMTALA (Emergency Medical Treatment and Active Labor Act) requires all patients seeking treatment at an Emergency Department to receive a Medical Screening Evaluation (MSE) to determine if am Emergency Medical Condition (EMC) is present. At the time patient #5 was discharged on 04/19/2024, and removed by police, he/she was displaying abnormal and agitated behavior indicative of potential ongoing emergency medical condition, as indicated by requesting to leave but then refusing to leave. Patient #5 was described by the discharging physician (MD #4) as “very agitated”, and up to that point was still under suicidal precautions. The hospital failed to provide evidence that an appropriate medical screening evaluation was completed to rule out if an Emergency Medical Condition persisted prior to discharge, as Patient #5 continued to display abnormal behaviors. This deficient practice had the likelihood to cause harm in all patients presenting to the ED with behavioral crisis and psychological complications. Refer to Tag 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: 30938 Based on review of documentation, interviews, and review of security video footage, it was determined that the facility failed to provide Patient #5, an appropriate medical screening exam at the facility’s Emergency Department (ED) prior to discharge on 04/19/2024. Findings: Facility policy entitled “EMTALA” last revised 02/14/2023, stated in part, “ It is the purpose of this policy to ensure that: (1) all patients who come to the hospital requesting emergency services receive an appropriate medical screening examination to determine if an emergency medical condition exists; (2) patients with an emergency medical condition (as defined below) are stabilized ...” “2.1 Medical Screening Examinations Generally. MMC/SMHC must provide an appropriate medical screening examination (MSE) to every individual covered by EMTALA, as defined in Section 1 of this Policy, based on the person’s medical circumstances and condition and without regard to the individual’s insurance status or ability to pay for the examination.” “2.2 What is a Medical Screening Examination (MSE)? A medical screening examination (MSE) is an examination by qualified, designated MMC/SMHC [Maine Medical Center/Southern Maine Health Care] personnel to determine with reasonable clinical confidence whether an individual has an emergency medical condition (EMC). The extent of the MSE is based upon the judgment and discretion of the physician or advanced practice provider (APP) as to what is necessary to accurately determine whether the individual does or does not have an EMC ...” “2.3 What is an Emergency Medical Condition (EMC)? An Emergency Medical Condition (EMC) is defined as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in (a) placing the health of the individual (or with respect to pregnant women, the health of the woman or her unborn child) in serious jeopardy; or (b) serious impairment to bodily functions, or (c) serious dysfunction of any bodily organ or part.” “2.3.2 Psychiatric Patients. A psychiatric patient is considered to have an EMC if either (a) acute psychiatric or acute substance abuse symptoms are manifested; or (b) the individual is expressing suicidal or homicidal thoughts or gestures and is determined to be a danger to self or others.” “3.2 Definition of Stabilized. A patient with an EMC will be considered stabilized if the treating physician has determined within reasonable clinical confidence that the patient is expected to leave the hospital (via either discharge or transfer to another facility) with no material deterioration in his or her medical condition.” “3.2.2 Psychiatric Patients. In the case of an individual who is suffering from a psychiatric condition(s), the individual is considered to be stable when he or she is protected and prevented from injuring himself/herself or others.” On 04/19/2024 at approximately 10:10 AM, patient #5 presented to the Emergency Department (ED) at Maine Medical Center accompanied by law enforcement. The triage note by RN #1 stated, “Pt presents from [Recovery home] for crisis evaluation. Increased SI [suicidal ideation], and paranoia. Denies plan. Pt is agitated and fidgeting on arrival, but cooperative with care at this time. Denies HI [homicidal ideation] at this time. Pt denies drug and alcohol use today. Endorses hallucinations, but states this is a constant problem for [him/her].” The triage note included a Columbia Suicide Scale (a suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs) completed by RN #1. Patient #5 was placed in a hallway bed in direct site of the nursing station, belongings secured by security and the patient was also provided set of paper scrubs to wear. On 04/19/2024 at approximately 10:36 AM, patient #5 was seen for an examination by MD #1 and MD #2. Patient medical record includes history of: Amphetamine-induced psychotic disorder with hallucinations, Psychosis, Schizoaffective disorder, bipolar type, and, Stimulant-induced disorder (Common psychological complications of stimulant use disorders include psychosis, depression, hypervigilance, and anxiety.) The physician note by MD#1 included: “ ... presents from Police Department behavioral health unit after being found acutely agitated. History is vague. At this time [he/she] does state that [he/she] uses alcohol and meth but is unable to provide a timeframe of use, at times nods yes to use within the past 24 hours but is unable to speak for self. Says yes to increased hallucinations, auditory and visual. Says no to suicidal ideation. Says that [he/she] hurts all specific details as to where in [his/her] body this is. Asked if [he/she] would like some medicine to help calm down [he/she] says if doctors thinks it is necessary that is fine ...” Additionally, a physical examination was performed, and laboratory blood testing ordered. Review of systems included: “Psychiatric/Behavioral: Positive for agitation and hallucinations. Negative for suicidal ideas. The patient is hyperactive.” The examination included the following statement: “Psychiatric: Comments: No suicidal or homicidal ideation. Endorses auditory and visual hallucinations. Behavior is abnormal, interrupted by whole body discoordinated spasms, asymmetrically and shaking in bed. Stares off into space while talking.” MD #2 ordered “OLANZapine (ZyPREXA) injection 5 mg” (a medication used to treat mental disorders, including schizophrenia and bipolar disorder and associated agitation) at 10:42 AM. To treat patient #5’s anxiety and agitation. This medication was administered at 10:51 AM. The patient record indicated multiple safety checks and medical/behavioral assessments by nursing staff throughout Patient #5’s time in the ED. Patient #5 remained on suicide precautions and hourly rounding during the time in the ED. At 3:27 PM nursing note by RN #2 reports; “Pt awake, crying, appears upset and asking for food.” Note indicates the patient remained in an “agitated state”. MD #4’s note at 3:45 PM stated: “I received this patient in signout. Patient is very agitated and wanting a cigarette. I reassessed the patient [he/she] is denying any SI or HI. [He/She] stated adamantly that [he/she] feels safe to leave and states over and over again that [he/she] “just wants a cigarette.” Patient discharged from the ED HDS [hemodynamically stable]. Medical record note by RN #2 indicated at approximately 4:28 PM on 04/19/2024, patient #5, “Pt refuses to leave after [he/she] requested a taxi voucher, which was provided. Discharge papers were provided. Pt continues to scream very loudly that [he/she] wants a cigarette. Pt refuses to leave. Dr [MD #3] was contacted. Security returned all personal belongings to pt.” Another nursing note by RN #3 reported, “Pt refusing to leave after given taxi voucher. Dr. [MD #4] at bedside and pt still refusing. This RN spoke with Dr. [MD #4] and agreed to call PD [police] as pt not leaving.” Patient #5 was discharged from the Emergency Department escorted by the local police department at approximately 5:00 PM on 04/19/2024. Review of security video shows patient escorted out of the ED by police. Patient appears to be yelling and staff appear to be shielding other patients from patient #5 as he/she exits the ED. Patient #5 appears to be yelling and stomping feet while leaving. Once outside the ED, patient #5 attempts to reenter the waiting room when in the entry vestibule, dropping items, circling back, continues to be wearing scrubs (at least the top) and blood pressure cuff is still attached to his/her arm. The information obtained in the patient record was additionally verified through interviews with various emergency department staff throughout the course of the complaint survey. Interviews with Chair of ED Psychiatry, (MD #5), who stated all patients receive a Columbia Suicide Scale which is completed by an RN. An assessment by an Emergency Department physician or PA will complete an assessment with “key questions” to immediately evaluate their level of safety risk. At this point the patient may stay as a 1:1 observation and referred to a team psychiatrist or a licensed clinical social worker who will evaluate and discuss case with a psychiatrist. Psychiatrist may or may not evaluate patient directly. MD #5 stated that when the patient is ready to be discharged, must agree to a “safety plan”. The safety plan includes seeking help. Interview with RN #2 on 05/03/2024 at approximately 11:14 AM, reported, “She recalled that the patient was very erratic, wanting to stay, but not wanting care. The patient was yelling and calling the nurse names and swinging at the nurse.” Additionally; “The patient kept asking for a cigarette, calling the staff names. offered the patient a nicotine patch, which was offered but refused and said [he/she] wanted to leave.” Patient #5 was discharged without evidence of an appropriate medical screening re-examination to determine if an emergency medical condition (EMC) continued/worsened, based on the documented change in his/her signs and symptoms. The hospital’s EMTALA policy states in part: “MMC/SMHC must provide an appropriate medical screening examination (MSE) to every individual covered by EMTALA.” The triage nurse note described him/her as presenting at time of admission with increased suicidal ideation, paranoia, auditory and visual hallucinations. Patient #5’s behavior was described by MD #1 as, “ ...abnormal, interrupted by whole body discoordinated spasms, asymmetrically and shaking in bed. Stares off into space while talking.” However, at the time of discharge, he/she was described as “very agitated”, “screaming loudly” and “refusing to leave the emergency department”. Security video displayed him/her yelling and stomping feet while leaving accompanied by police and security, making attempts to reenter the emergency department, dropping items, and circling back, with uncoordinated movements.”

“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, the hospital failed to ensure nursing staff wore personal protective equipment during the care of a patient on isolation status for one (1) out of one (1) patients observed in a room with precautions on Unit R5 (Patient #11). Findings: The hospital’s policy titled, “Drug Resistant Organism Precautions”, last revised 02/2023 states in part, “ ... Gloves are indicated for all healthcare workers prior entry into room. Change gloves after contact with infective material. Remove gloves before leaving the patient’s room ... .” “...Gowns are indicated for all healthcare workers prior entry into room. Remove gown before leaving the patient’s environment ...”. A booklet the hospital provides to patients titled, “The Patient Care Partnership: Understanding Expectations, Rights, and Responsibilities”, dated 10/2022 states in part, “ ...What to expect during your hospital stay: High quality hospital care. A clean and safe environment ... .” Certified Nursing Assistant (“CNA”) #1’s Learning Management System transcript was reviewed, and showed that he completed, “2023 MMC EOC Infection Prevention Training for Clinical Staff” on 01/18/2024. CNA #1’s Competency Based Orientation Tool was reviewed and was signed by his preceptor on 01/18/2024, indicating that he was able to independently, “ ... Demonstrate appropriate use of and disposal of personal protective equipment ... .” On 3/4/2024 at 12:41 PM, surveyors observed a sign on Patient #11’s door indicating Drug Resistant Organism (“DRO”) precautions are required, including, “ ... Staff must wear gown and gloves before entering room ... .” This observation revealed the following: - CNA #1 was observed in Patient #11’s room at the foot of the bed; and - CNA #1 was not wearing any personal protective equipment. On 3/4/2024 at 12:41 PM, CNA #1 acknowledged to the surveyors that he should have been wearing personal protective equipment while in the room. CNA #1’s failure to follow DRO precautions subsequently placed all other patients and/or staff he came into contact with that day at risk of potential exposure to Drug Resistant Organisms.”

“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: 48232 Based on document reviews, interviews and observations, the hospital failed to ensure nursing staff followed the hospital’s Drug Resistant Organism Precautions policy for one (1) of one (1) patients observed in a room with precautions on Unit R5 (Patient #11). Findings: The hospital’s policy titled, “Drug Resistant Organism Precautions”, last revised 02/2023 states in part, “ ... Gloves are indicated for all healthcare workers prior entry into room. Change gloves after contact with infective material. Remove gloves before leaving the patient’s room ... .” “...Gowns are indicated for all healthcare workers prior entry into room. Remove gown before leaving the patient’s environment ...”. On 3/4/2024 at 12:41 PM, surveyors observed a sign on Patient #11’s door indicating Drug Resistant Organism Precautions (“DRO”) are required, including, “ ... Staff must wear gown and gloves before entering room ... .” This observation revealed the following: - Certified Nursing Assistant (“CNA”) #1 was observed in Patient #11’s room at the foot of the bed; and - CNA #1 was not wearing any personal protective equipment. On 3/4/2024 at 12:41 PM, CNA #1 acknowledged to the surveyors that he should have been wearing personal protective equipment while in the room.”