Maine General Medical Center

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 52959 Based on document reviews and interviews, the hospital failed to ensure nursing staff in the Emergency Department identified patients using two (2) patient identifiers prior to medication administration for one (1) out of five (5) patient records reviewed (Patient #4). The hospital’s failure to implement systemic changes following the hospital’s discovery of this incident led to Nurse #2 failing to identify a patient using two (2) patient identifiers during one (1) of three (3) subsequent medication administrations observed by the survey team. Findings Policy MM-04 (Attachment 2), entitled, “Best Practice Guideline for Safe Medication Administration,” revised April 2025, outlines steps for medication administration and states, in part, that clinical staff should “...Conduct the “5 R’s” process with the patient identifying the patient accordingly per policy ... PC-04: Patient Identification (ID) For Clinical Care and Treatment).” Policy PC-04, entitled, “Patient Identification (ID) for Clinical Care and Treatment,” reviewed/revised February 2026, states, in part: “Proper identification of all hospital patients includes: 1. Use of two consistent identifiers: full name, including middle initial, if available, and date of birth. The third identifier that will be used is the medical record number ... 2. The exact positive correlation between information obtained from the patient (verbal or ID band) and medical information utilized for service ...” Policy PC-04 also addresses checking patient wrist bands prior to medication administration and states, in part: “ ...In the Emergency Department, an identification band will be prepared immediately upon patient entry to the Emergency Department treatment area ... 5. Patient identification must be confirmed using the two-identifier system (full name and date of birth) prior to conducting any healthcare service ...” On 6/12/2026 at approximately 3:55PM, Physician #1 documented that Patient #4 had experienced a medication error and received three medications, “dexamethasone was 4mg [sic], Toradol 30mg IM, and Tylenol 1,000mg,” which were ordered for another patient. During an interview on 07/15/2026, at approximately 4:25PM, Nurse #1 confirmed that on 06/12/2026, they failed to check Patient #4’s wrist band and erroneously administered medications to Patient #4 that had been ordered for Patient #2. The facility confirmed they became aware of the medication error involving Patient #4 on 06/15/2026. Administrator #3 stated that a departmental review was conducted by the Emergency Department; additionally, Administrator #1 stated that the incident was reviewed with Nurse #1 and determined the source of the error was that Nurse #1 failed to use their departmental tools for safe medication administration, including a Workstation on Wheels (WOW) at the patient’s bedside. However, throughout the survey, the hospital failed to provide evidence that systemic changes have been made to prevent this problem from reoccurring. During interviews on 7/16/2026, Administrator #1 and Administrator #3 each stated that the Emergency Department does not currently have a medication administration system that scans barcodes on patient wrist bands to reduce errors. Additionally, during a medication pass observation conducted in the Emergency Department on 7/16/2026, at approximately 10:48AM, a surveyor observed Nurse #2 fail to identify a patient using two (2) patient identifiers prior to administering Morphine 4mg IV. This finding was confirmed by Nurse #2, Administrator #1, and Administrator #2 at approximately 10:53AM.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 52959 Based on a document review of nineteen (19) provided Emergency Department and Medication Administration policies, the facility failed to review and/or revise thirteen (13) policies within the past two (2) years, as directed by hospital policy. Findings Policy LD-05 entitled, “Policy and Procedure Development, Issuance, and Standard Format,” reviewed/revised May 2025, states, in part: “System policies and departmental procedures should be reviewed every two years or as required by regulation. Departmental procedures should be reviewed every two years or as required by regulation...” A review of the nineteen (19) Emergency Department and Medication Administration policies and procedures provided by the hospital as current revealed that a total of thirteen (13) policies were not documented as reviewed and/or revised within the past two (2) years: 1. ED-04 Care of Patients with Behavioral Health Needs in the ED (3/2024) 2. ED-09 EMS Local Destination Protocol to the Alfond Center for Health (12/2023) 3. ED-32 Limited ED Visitor Policy (8/13/2020) 4. ED-33 Vital Sign Guidelines for ED Patients (8/2022) 5. ED-35 Triage of Potentially Infectious Patients (12/2023) 6. ED-01 After Hours Ultrasound Activation and Next Day Ultrasound Results (10/2023) 7. ED-17 Dead on Arrival Patients in Emergency Services (10/2023) 8. ED-19 Procedure for Emergency Services Triage (10/2023) 9. ED-28 Telephone Advice, Results, Payment Information or Wait Times (10/2023) 10. ED-32 Visitors in the Emergency Department (10/2023) 11. Procedure for Proper Disposal of Discovered and Unsecured Medications (Labeled or Unlabeled) (11/2023) 12. Medication Administration Timing Guidelines (11/2023) 13. Authorized Personnel for Medication Storage Areas (11/2023) Per email correspondence from Administrator #2 on 7/15/2026 and 07/16/2026, the policies above were provided as the current policies at the facility.”

“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: 46424 Based on document reviews and interviews, the facility failed to ensure that staff reported medication errors in accordance with their internal variance reporting policy. Findings: Policy PI-01, entitled, “Variance Reporting,” states, in part, “MaineGeneral Medical Center staff who are involved in or observe a variance are responsible for reporting the variance while maintaining confidentiality.” Additionally, under the sub-heading, “Variance Report Completion,” the policy states, in part: “1. The employee or Medical Staff member involved in, observing, or discovering the unusual occurrence is responsible for initiating a Variance Report. 2. Variance Reports should be completed within 24 hours of discovery. All parts of the variance reporting form must be completed. 3. Supervisors, managers, and directors will receive and review variance reports pertaining to their designated areas of oversight and provide follow-up documentation within the electronic variance reporting software.” Additionally, MaineGeneral’s “Ethics & Compliance Memo” authored on 9/28/2023 by the hospital’s Compliance Specialist describes the expected ordering and documentation process for Sublocade injections. Under “Documentation Requirements,” the memo states, in part: “ ...Documentation will be maintained in the [Electronic Medical Record] system. A physician order is required and documentation must support the medical necessity (please see the requirements outlined in coverage criteria above) of the Sublocade [an injectable medication] Injection in order for payment to be received. The specific order needs to be created. Please contact IT directly to set up before implementation, as the order must be signed prior to administration. The order must include: 1. Patient name and date of birth 2. Requesting practitioner name, legible signature with credentials, that is dated and timed 3. Name of the study, test, medication etc. requested 4. Best Practice: Sign/symptom/indication (S/S/I) for study test, medication etc ...” Patient #1’s medical record revealed Nurse Practitioner #1 wrote a paper order for three-hundred-milligrams (300mg) Sublocade injection for six (6) doses on 1/20/2026. The paper order form indicated three-hundred-milligrams (300 mg) of Sublocade was administered by Certified Medical Assistant (“CMA”) #1 on 1/22/2026 and 2/19/2026. Documentation in the electronic medical record for Patient #1 revealed an electronic order for, “Sublocade [one-hundred-milligrams] 100 MG,” and not the three-hundred-milligrams (300 mg) that had been administered to Patient #1 on 1/22/2026 and 2/19/2026. During an interview on 05/06/2026 at 9:09AM, Nurse Practitioner #1 stated, “I filled out the paperwork incorrectly, and [Patient #1] got a [three-hundred-milligram] 300mg dose.” Nurse Practitioner #1 stated that they read the paper order and faxed it to the Physiatry clinic. When the survey team inquired about what Nurse Practitioner #1 did after they discovered the medication error. Nurse Practitioner #1 stated, “The error just came to my attention yesterday afternoon [on 05/06/2026].” Nurse Practitioner #1 then stated, “Back in March [2026], I corrected the order.” Nurse Practitioner #1 confirmed that they modified the order after the medication was administered by CMA #1 on 1/22/2026 and 2/19/2026. Nurse Practitioner #1 stated, “I think what happened is that [Patient #1] called and got the larger dose. I got [the] second call, and I adjusted the dose. On March 4th [2026], I corrected the order forms.” When the survey team inquired as to why Nurse Practitioner #1 didn’t report the medication error on 3/4/2026, Nurse Practitioner #1 responded, “I’m not sure.” Practice Administrator #1 was present during this interview and added, “It should have been reported.” Internal documentation from MaineGeneral Addiction Medicine-Waterville indicated that as of 02/19/2026, Practice Administrator #2 was made aware of a potential dosing error but did not report it, in violation of Policy PI-01: On 02/19/2026, Patient #1 spoke to Practice Administrator #2 via phone and reported and stated they thought they were “given 300 and should have been given 100.” Practice Administrator #2 documented, “Explained that pt was given 300 Sublocade during their January 22, 2026 injection and Order for the injection was for 300mg.””

“ORDERS FOR OUTPATIENT SERVICES CFR(s): 482.54(c) §482.54(c) Standard: Orders for Outpatient Services. Outpatient services must be ordered by a practitioner who meets the following conditions: (1) Is responsible for the care of the patient. (2) Is licensed in the State where he or she provides care to the patient. (3) Is acting within his or her scope of practice under State law. (4) Is authorized in accordance with State law and policies adopted by the medical staff, and approved by the governing body, to order the applicable outpatient services. This applies to the following: (i) All practitioners who are appointed to the hospital’s medical staff and who have been granted privileges to order the applicable outpatient services. (ii) All practitioners not appointed to the medical staff, but who satisfy the above criteria for authorization by the medical staff and the hospital for ordering the applicable outpatient services for their patients. This Standard is not met as evidenced by: 46424 Based on document reviews and interviews, the hospital failed to ensure consistency between paper and electronic medication orders in one (1) out of ten (10) patient medical records reviewed (Patient #1). This failure led to Patient #1 receiving an incorrect dose of a prescribed medication Findings: MaineGeneral’s “Ethics & Compliance Memo” authored on 9/28/2023 by the hospital’s Compliance Specialist describes the expected ordering and documentation process for Sublocade injections. Under “Documentation Requirements,” the memo states, in part: “ ...Documentation will be maintained in the [Electronic Medical Record] system. A physician order is required and documentation must support the medical necessity (please see the requirements outlined in coverage criteria above) of the Sublocade [an injectable medication] Injection in order for payment to be received. The specific order needs to be created. Please contact IT directly to set up before implementation, as the order must be signed prior to administration. The order must include: 1. Patient name and date of birth 2. Requesting practitioner name, legible signature with credentials, that is dated and timed 3. Name of the study, test, medication etc. requested 4. Best Practice: Sign/symptom/indication (S/S/I) for study test, medication etc ...” The hospital’s policy PI-01, titled “Variance Reporting,” states, in part, “MaineGeneral Medical Center staff who are involved in or observe a variance are responsible for reporting the variance while maintaining confidentiality.” Additionally, under the sub-heading, “Variance Report Completion,” the policy states: “1. The employee or Medical Staff member involved in, observing, or discovering the unusual occurrence is responsible for initiating a Variance Report. 2. Variance Reports should be completed within 24 hours of discovery. All parts of the variance reporting form must be completed. 3. Supervisors, managers, and directors will receive and review variance reports pertaining to their designated areas of oversight and provide follow-up documentation within the electronic variance reporting software.” Patient #1’s medical record revealed Nurse Practitioner #1 wrote a paper order for three-hundred-milligrams (300mg) Sublocade injection for six (6) doses on 1/20/2026. The paper order form indicated three-hundred-milligrams (300 mg) of Sublocade was administered by Certified Medical Assistant (“CMA”) #1 on 1/22/2026 and 2/19/2026. Documentation in the electronic medical record for Patient #1 revealed an electronic order for, “Sublocade [one-hundred-milligrams] 100 MG,” and not the three-hundred-milligrams (300 mg) that had been administered to Patient #1 on 1/22/2026 and 2/19/2026. During an interview on 05/06/2026 at 9:09AM, Nurse Practitioner #1 stated, “I filled out the paperwork incorrectly, and [Patient #1] got a [three-hundred-milligram] 300mg dose.” Nurse Practitioner #1 stated that they read the paper order and faxed it to the Physiatry clinic. When the survey team inquired about what Nurse Practitioner #1 did after they discovered the medication error, Nurse Practitioner #1 stated, “The error just came to my attention yesterday afternoon [on 05/06/2026].” Nurse Practitioner #1 then stated, “Back in March [2026], I corrected the order.” Nurse Practitioner #1 confirmed that they modified the order after the Sublocade was administered by CMA #1 on 1/22/2026 and 2/19/2026. Nurse Practitioner #1 stated, “I think what happened is that [Patient #1] called and got the larger dose. I got [the] second call, and I adjusted the dose. On March 4th [2026], I corrected the order forms.” When the survey team inquired as to why Nurse Practitioner #1 didn’t report the medication error on 3/4/2026, Nurse Practitioner #1 responded, “I’m not sure.” Practice Administrator #1 was present during this interview and added, “It should have been reported.””

“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: 49750 Based on document reviews, interviews and observations, the hospital failed to ensure nursing staff followed the hospital’s MaineGeneral Best Practice Guideline for Safe Medication Administration-Attachment 2, and MaineGeneral Medical Centers’s Infection Control Cleaning and Disinfection of Patient Equipment policy, last reviewed/revised 02/2024, for one (1) of one (1) registered nurse’s observed. (RN #1). Findings: -The hospital’s policy titled, “MaineGeneral Best Practice Guideline for Safe Medication Administration-Attachment 2” states in part, “ ...Medication administration will be conducted one patient at a time.” -The hospital’s policy titles, “MaineGeneral Medical Centers’s Infection Control Cleaning and Disinfection of Patient Equipment policy, last reviewed/revised 02/2024, states in part, “ ...Critical items confer a high risk for infection if they are contaminated with any microorganism. Thus, objects that enter sterile tissue or the vascular system must be sterile because any microbial contamination could transmit disease ... Follow manufacturers’ instructions for proper use of disinfecting (or detergent) products.” -The container that the facility receives the prefilled saline syringes from the manufacturer has the instructions for use (IFU) printed directly on the container and in part, states the following “ ...do not re-sterilize ...Do not reuse ...For Single use only ...store at 20-25? C(Celsius)/68-77? F (Fahrenheit) ...” -On 2/10/2026 at 9:04 AM, surveyors observed RN #1 preparing medications for Pt. #11 in the medication room and then proceeding to pt #11’s room to administer medications. No intravenous medications were prepared. This observation revealed the following: - RN #1 was observed to be carrying four (4) prefilled saline syringes in the cargo pocket on her scrub pant leg when entering and exiting patient #11’s room. When asked about the prefilled syringes in her pant leg pocket, RN #1 responded “yes, because we have to do so many IV (intravenous) medications.” -On 2/10/2025 at 9:15 AM, the Associate Director of Nursing and Care Management and the Nurse Manager for this unit both confirmed that RN #1 was carrying prefilled syringes in the cargo pocket on her scrub pant leg. -On 2/11/2026 @ 8:30 AM, the Associate Director of Nursing and Care Management and Chief Compliance Officer and Administrative Director confirmed that the prefilled syringes were not being stored (in pant leg pocket) per manufacturer’s instructions.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to inform a patient/patient representative of patient’s rights in advance of providing care for one (1) of ten (10) patients reviewed (Patient #1). Finding: The MaineGeneral Medical Center “Informed Consent” policy’s purpose, last reviewed/revised in 01/25, states in part, “To establish the right of a patient or their representative, as allowed under Maine law, to make informed decisions regarding their health care. The patient’s rights include being informed of their health status, being involved in care planning and treatment, and being able to request or refuse treatment.” In addition, it states, “Health care decisions for incompetent adults may be made by others expressly authorized to make such decisions or by family members in certain circumstances. Authorized decision-makers do NOT have the authority to make decisions contrary to the decisions made by the patient while competent. Authorized decision-makers are determined in the following order of priority: ... Guardians: If there is no agent under a power of attorney and a guardian has been appointed by a court, consent should be obtained from the guardian if consent to medical care is included in the court order.” On 04/02/2025 from 10:30 AM to 11:30 AM, ten (10) medical records were reviewed with the Nurse Director and the Assistant Nurse Director of the Emergency Department. This review indicated the following: - Patient #1 had a Guardian; - Patient #1 had ten (10) visits to the hospital between 10/28/2024 and 03/29/2025; and - Seven (7) visits contained no documented evidence that the Guardian was informed of patient rights in advance of care being provided, as no notification or contact was initiated by the Patient Access Team at the time of registration. On 04/02/2025 at 3:16 PM, an interview was conducted with the Manager of Patient Access which indicated the following: - I became aware of this [in regard to Patient #1] in January; - [Paperwork such as Guardianship] gets scanned into the medical record system, but the Patient Access Team would not be notified immediately; - I ensured that the guardianship information was in the system on 1/23/2025; and - I was aware of the continued issues with Guardian consent and have been working with staff members on an individual basis. On 04/02/2025, the ED Nurse Director confirmed that seven (7) of ten (10) visits contained no evidence of Guardian notification.”

“PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, the hospital failed to inform a patient/patient representative of his/her rights in regards to having the right to participate in the development and implementation of the plan of care for one (1) of ten (10) patients reviewed (Patient #1). Finding: The MaineGeneral Medical Center “Informed Consent” policy’s purpose, last reviewed/revised in 01/25, states in part, “To establish the right of a patient or their representative, as allowed under Maine law, to make informed decisions regarding their health care. The patient’s rights include being informed of their health status, being involved in care planning and treatment, and being able to request or refuse treatment. ... When indicated, each patient or the patient’s legal representative, signs a general consent or verbally expresses their consent and MGMC staff will document as part of the registration process. This general consent documents the patient’s consent to routine medical care. Oral consent from a patient or their designated representative may be substituted for written consent if the verbal consent is documented on the general consent form. These forms of consent must be given by an authorized individual. The individual providing oral consent must provide adequate information to confirm their identity as well as that of the individual they are consenting for. In person and telehealth verbal consents may be accepted and documented by one representative of MaineGeneral... .” In addition, “The patient or the patient’s legal representative should receive adequate information provided in a manner that the patient or the patient’s legal representative can understand to assure that the patient can effectively exercise the right to make informed decisions. The responsible practitioner must provide as much information about treatment options as is necessary based upon a patient’s understanding of the practitioner’s explanation of the risks, benefits and likely outcomes of the treatment. On 04/02/2025 from 10:30 AM to 11:30 AM, ten (10) medical records were reviewed with the Nurse Director and the Assistant Nurse Director of the Emergency Department. This review indicated the following: - Patient #1 had a Guardian; - Patient #1 had ten (10) visits to the hospital between 10/28/2024 and 03/29/2025; and - Seven (7) visits contained no documented evidence that the Guardian was informed of their rights about participating in the plan of care. On 04/02/2025, the ED Nurse Director confirmed that seven (7) of ten (10) visits contained no evidence of Guardian notification.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, it was determined that the hospital failed provide notice to a patient’s representative about the right to make informed decisions regarding care for one (1) of ten (10) patients reviewed (Patient #1). Findings: The MaineGeneral Medical Center “Informed Consent” policy’s purpose, last reviewed/revised in 01/25, states in part, “To establish the right of a patient or their representative, as allowed under Maine law, to make informed decisions regarding their health care. The patient’s rights include being informed of their health status, being involved in care planning and treatment, and being able to request or refuse treatment. ... When indicated, each patient or the patient’s legal representative, signs a general consent or verbally expresses their consent and MGMC staff will document as part of the registration process. This general consent documents the patient’s consent to routine medical care. Oral consent from a patient or their designated representative may be substituted for written consent if the verbal consent is documented on the general consent form. These forms of consent must be given by an authorized individual. The individual providing oral consent must provide adequate information to confirm their identity as well as that of the individual they are consenting for. In person and telehealth verbal consents may be accepted and documented by one representative of MaineGeneral... . ... “Authorized Decision-Maker: An authorized decision-maker is any person who is: (1) Legally authorized to make medical decisions on behalf of an incompetent patient, (2) the patient’s agent as defined in this policy, (3) the patient’s guardian if one has been appointed, or (4) the patient’s involved family members.” In addition, “The patient or the patient’s legal representative should receive adequate information provided in a manner that the patient or the patient’s legal representative can understand to assure that the patient can effectively exercise the right to make informed decisions. The responsible practitioner must provide as much information about treatment options as is necessary based upon a patient’s understanding of the practitioner’s explanation of the risks, benefits and likely outcomes of the treatment. On 04/02/2025 from 10:30 AM to 11:30 AM, ten (10) medical records were reviewed with the Nurse Director and the Assistant Nurse Director of the Emergency Department. This review indicated the following: - Patient #1 had a Guardian; - Patient #1 had ten (10) visits to the hospital between 10/28/2024 and 03/29/2025; and - Seven (7) visits contained no documented evidence that the Guardian was notified of their right to make informed decisions, as no notification or contact was initiated by the Patient Access Team at the time of registration. On 04/02/2025, the ED Nurse Director confirmed that seven (7) of ten (10) visits contained no evidence of Guardian notification.”

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 42601 Based on document reviews and interviews, it was determined that the hospital failed to document that a patient’s guardian was asked if they had an advanced directive and/or did they want to execute one for one (1) of ten (10) patients reviewed (Patient #1). Finding: The MaineGeneral Medical Center (“MGMC”) “Advance Directives- Healthcare Decision Making” policy, last reviewed/revised 11/23, states in part, “Decision-Makers for Adults Who Lack Capacity: (1) Healthcare decisions for adults who lack capacity may be made by others expressly authorized to make such decisions or by family members in certain circumstances. Authorized decision-makers are determined in the following order of priority: Guardians ... .” In addition, it also states, “Documentation: As part of the admission process for all adult individuals, the admitting agent will ask and record whether an advance directive, e.g. Living Will or Durable Healthcare Power of Attorney is in effect and on file with MaineGeneral. A copy of the advance directive will be requested and filed in the medical record ... .” The MGMC “Patient Visitation Rights” policy, last reviewed/revised 08/23, states in part, “Registration: At the time of admission, MGMC’s registration personnel will ask the patient if the patient has an agent under a healthcare power of attorney and whether the patient wishes to rely on his or her agent to exercise the patient’s visitation rights. If the patient lacks an available agent, the patient will be asked whether he or she wishes to designate a support person to exercise the patient’s visitation rights, or rely on his or her healthcare surrogate designated under Maine law to exercise such visitation rights. Registration personnel will document the patient’s decision, and MGMC staff will honor the patient’s decision unless an exception applies under this Policy.” On 04/02/2025 from 10:30 AM to 11:30 AM, ten (10) medical records were reviewed with the Nurse Director and the Assistant Nurse Director of the Emergency Department. This review indicated the following: - Patient #1 had a Guardian; - Patient #1 had ten (10) visits to the hospital between 10/28/2024 and 03/29/2025; and - Seven (7) visits contained no documented evidence that the Guardian was asked about advanced directives for Patient #1, as no notification or contact was initiated by the Patient Access Team at the time of registration.. On 04/02/2025, the ED Nurse Director confirmed that seven (7) of ten (10) visits contained no evidence of Guardian notification.”

“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 one (1) of five (5) restrained patients (Patient 1R). Finding: MaineGeneral Medical Center’s “Restraint or Seclusion of Patients” policy last revised 07/2024 states in part, “While the patient is in restraint, the staff responsible for the patient will document the following: ... Alternative measures utilized prior to application of restraints and patient’s response to the alternatives.” On 10/09/2024 at 12:33 PM, five (5) records were reviewed with the Emergency Department Nurse Director. This review revealed the following: Documentation in Patient 1R’s record indicated the following: - Registered Nurse (“RN”) #1 documented that Patient 1R had bilateral soft wrist restraints applied on 09/02/2024 at 1:47 PM; - RN #1 documented that Patient 1R had the restraints discontinued on 09/02/2024 at 5:11 PM; and - There was no documented evidence in the medical record that would show that less restrictive measures were attempted. On 10/09/2024 at approximately 12:35 PM, the above findings were confirmed with the Emergency Department Nurse Director, 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: 42601 Based on document reviews and interviews, the hospital failed to ensure a physician’s order was obtained for one (1) of five (5) patients that were restrained (Patient 1R). Finding: MaineGeneral Medical Center’s “Restraint or Seclusion of Patients” policy last revised 07/2024 states in part, “Restraint devices may be used only with the order of a physician or other licensed independent practitioner, under the standard conditions where the primary purpose is for non-violent or non-self-destructive behavior.” On 10/09/2024 at 12:33 PM, five (5) records were reviewed with the Emergency Department Nurse Director. This review revealed the following: 1. Documentation in Patient 1R’s record indicated the following: - On 09/02/2024 at 1:477 PM, Patient 1R required bilateral soft wrist restraints; - The restraint was discontinued at 5:11 PM; and - There was no evidence in the medical record of a Provider order for the bilateral soft wrist restraints. On 10/09/2024 at approximately 12:40 PM, the above findings were confirmed with the Emergency Department Nurse Director, at the time of the review.”

“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, observations and interviews, the hospital failed to maintain all facilities and equipment to ensure an acceptable level of safety and quality at MaineGeneral Express Care on 15 Enterprise Drive in Augusta, ME . Findings: - On 06/20/2024 at 11:41 AM an interview was conducted with Practice Administrator #1, who stated room 14 was closed, as of 06/20/2024, (the date of the initiation of the survey). She stated she put a sign up on 06/20/2024. Practice Administrator #1 was asked if the room was being used prior to 06/20/2024. She confirmed the room was being used prior to 06/20/2024. She stated that if they had to use the exam table it would be an infection control issue due to a tear in the exam table. She stated the room was being used, but not if there were infection prevention concerns. Practice Administrator #1 was asked if she closed room 14 in response to the initiation of the survey. Practice Administrator #1 confirmed that she closed room 14 in response to the initiation of the survey. - On 06/20/2024 at 11:46 AM it was observed that room 14 had the door closed with a paper sign taped to the door which read, “STOP Do NOT use this Room Until table top is repaired.” The exam table cover in room 14 was observed to be torn in 2 places. -On 06/20/2024 at 11:56 AM an interview was conducted with Medical Assistant #1 who stated one of the tables had a rip in it that they were trying to replace in room 14. He stated the exam table had a rip in it and the foam was showing. He stated it has been like this ever since he can remember. He stated he has been working [at the 15 Enterprise Drive Location] since March 2023. He confirmed they have been seeing patients in room 14 as recently as 06/19/2024. He stated that room 14 was not in any special status where patients with certain conditions could not be placed in the room. -On 06/20/2024 an interview was conducted with RN #1, who confirmed the bed [exam table] in room 14 was in use prior to 06/20/2024. She stated they did not restrict placing patients with any specific conditions in room 14 when it was being used.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 49750 Based on document reviews, observations and interviews, the hospital failed to comply with the operating room policies and procedures related to surgical attire and personal electronic devices for one (1) of one (1) observed surgical procedures. Findings: MaineGeneral Medical Center “Surgical Services Departmental Procedures” policy, last reviewed on 02/2023, states in part, “To define what is acceptable, allowable attire in the Operating Rooms and to maintain environmental control within the Surgical Department. Adapted from AORN [Association of Perioperative Registered Nurses] Guidelines for Perioperative Practice: Guideline for Surgical Attire - 2021 Edition.” ... “Fingernail polish free from chipping may be worn in the operating room by personnel. Artificial nails or gels, which harbor organisms and prevent effective hand washing, will not be worn in the operating room by OR personnel. This includes bonding, tips and wrapping, gels and shellac.” MaineGeneral Medical Center “Hand Hygiene” policy, last reviewed 8/23, states in part, “All providers/staff/students/volunteers that provide direct patient care or have contact with patient care supplies, equipment or food will comply with this hand hygiene policy.” ...”Fingernails: Studies note artificial and/or long natural fingernails harbor microorganisms, creating a reservoir, which may increase the risk of infection in the patient in the acute care setting.” The policy defines artificial fingernails as, “Substances or devices applied or added to the natural nail to augment or enhance the wearer’s own nails. This includes, but is not limited to: acrylic, gels, bonding, tips, wraps, shellacs, tapes or overlays. Nail piercing jewelry of any kind is also included in the definition for the purposes of this policy.” ...”Natural fingernails: Defined as natural nails without an artificial covering other than nail polish. Maintenance of natural fingernails on employees who may not wear artificial fingernails: Nails must be trimmed so they are no longer than 1/8 to 1/4 inch past the tip of the finger. They may need to be shorter to avoid puncturing gloves or injuring patients in certain situations as determined by the employee’s manager. Polish, if worn, must be in good repair without cracks or chips.” ... “Artificial Fingernails: The following employees will not be allowed to wear artificial fingernails. Direct patient care providers (*Category IA CDC recommendation). Employees who have contact with patient care supplies or equipment (i.e. Central Sterile or Lab) ...Please Note: Either natural or artificial fingernail piercing’s with or without jewelry embedded is prohibited. Either natural or artificial fingernails that interfere with performance of one’s job duties as determined by the employee’s manager is prohibited.” MaineGeneral Medical Center “Personal Electronic and IoT Devices” policy, last reviewed on 1/23, states in part, “Personal electronic devices (PEDs) are not to be used in patient care areas at any MaineGeneral facility unless that usage is directly related to conducting MaineGeneral business. No personal PEDs may be used while traveling throughout the facility (hallway, elevators, and stairwells). PEDs may only be used for personal use in designated areas during break times. These areas may include the cafeteria, breakrooms, etc. Some departments may have more specific guidelines regarding the storage and usage of PEDs while at work. PEDs include but are not limited to mobile devices such as Kindles, Nooks, iPads, tablets, cellular phones, smartphones, pagers, Bluetooth, laptops, voice recorders and gaming devices.” 1. Fingernail / Hand Hygiene On 3/20/2024 at 6:00 AM, the Perioperative Nursing Supervisor was observed in the peri-operative area. She was noted to have artificial nails that extended past the pad of the finger. When asked if she performed patient care, she stated, “At times.” The Perioperative Nursing Supervisor confirmed that she has “bonded gel nails”. On 3/20/2024 between 7:40 AM and 10:30 AM, an operation was observed and revealed the following: -The Surgical Services Nurse Manager had a nail application on her fingernails that had flaked and lifted in some areas; and -The Surgical Services Nurse Manager was observed placing a gown on surgical staff, who then proceeded to the sterile area. On 3/21/2024 at 9:18 AM, the Surgical Services Nurse Manager confirmed that she had a nail application that bonded to the natural nail. 2. Personal Electronic Devices On 3/20/2024 between 7:40 AM and 11:00 AM, the Surgical Services Department was observed and revealed the following: - Medical Doctor (“MD”) #1 was observed retrieving his cell phone from his shirt pocket and made multiple calls from the operating room; - Surgical Technician #1 was observed to carry her personal cell phone in her pant pocket under her sterile gown, which she confirmed; and - a Laboratory Technician was observed using her cell phone while in the post anesthesia care unit hallway. On 3/21/2024 at approximately 9:18 AM, the Surgical Services Nurse Manager and the Administrative Director of Surgical Services confirmed that surgical services personnel are allowed to carry and use their personal cell phones in the restricted areas of the Surgical Services Department. They stated that all surgical services personnel are to “wipe down their cellphone with a wipe that is designed to clean cell phones.” However, this cleaning process was not observed at any time. On 3/21/2024 at approximately 9:20 AM, the Administrative Director of Surgical Services stated there is no written policy or procedure for wiping down cellphones in the Surgical Services Department. On 3/21/2024 at approximately 9:25 AM, Administrative Director of Surgical Services, was interviewed regarding cell phone use within the Surgical Services Department, and confirmed that there are no specific cellphone policies for this department. Current Association of Perioperative Registered Nurses (“AORN”) guidelines, dated 2023, address this topic in Managing Distractions and Noise during Perioperative Care. These guidelines have not been implemented by Surgical Services Department at MaineGeneral Medical Center despite the Administrative Director of Surgical Services, stating that they follow current AORN guidelines. On 3/21/2024 at 2:58 PM, a telephone interview was conducted with MD #1. He confirmed that he utilized his cell phone in the operating room stating, “I was not aware I could not use it [cellphone] in the operating room.” When asked about the process of wiping the cell phone down at the beginning of the day while in the restricted area, he responded “I am not aware of that process.””

“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 insulin was administered in accordance with the provider’s orders one (1) out of twenty (20) sampled patients (Patient #2). Findings: 1. Patient #2’s medical record was reviewed and revealed that Patient #2 had a history of type 1 diabetes. 2. Patient #2’s medical record contained a Physician Note by Physician #1 dated 02/11/2024 at 2:25 PM which reads in part: “ ...Physician Note REASON FOR ADMISSION: Diabetic ketoacidosis ...” 3. Patient #2’s medical record contained an order for regular insulin dated 01/29/2024 at 5:31 PM. The order stated a dose of insulin was ordered for 20:00 (8 PM) on 01/29/2024. The order reads in part: “ ...01/29/2024 17:31 Insulin Reg (S/S) U100 Ordered by: [Physician #2] {FALL RISK} (High Alert Drug), Injection, SubCutaneous, <User Schedule> ( every 1 day: 00:00, 04:00, 08:00, 12:00, 16:00, 20:00 ) ...” 4. Patient #2’s medical record contained an entry stating a Glucose Meter, Point of Care blood glucose level was obtained and Patient #2’s blood glucose level was 445 at 8:36 PM on 01/29/2024. 5. Patient #2’s medical record showed that the 8 PM ordered dose of insulin was not administered until at 9:59 PM on 01/29/202, with 13 units of regular insulin administered by RN #1. This was 1 hour and 59 minutes after the ordered administration time, and 1 hour and 23 minutes after the point of care blood glucose level of 445 was obtained. 6. At 9:30 AM on 02/14/2024 a telephone interview was conducted with Physician # 3, one of the physicians who was caring for Patient #2 on 01/29/2024. During the interview Physician #3 was asked, “What are the risks associated with a blood glucose level of 445 in a patient who has type 1 diabetes?”: Physician #3 stated that if the patient became hyperglycemic (high blood sugar), they could become dehydrated if they lose too much glucose in the urine. She stated that generally patients could potentially go into Diabetic Ketoacidosis (DKA) if they don’t have enough endogenous insulin, which she stated is why they should always have either long acting or short acting insulin on board. Physician #3 was asked, “For a patient with type 1 diabetes who has a blood glucose level of 445, and an ordered dose of insulin which was available to be administered immediately, what is an acceptable timeframe for the administration of the dose of insulin?”: At 9:31 AM on 02/14/2024 Physician #3 stated that the dose of insulin should be administered within an hour at the most of the scheduled administration time. Physician #3 stated, “It depends on what else is going on, but the patient could potentially go into DKA if they do not receive the insulin in an hour.” Physician #3 stated the risks of DKA could be that the patient could become dehydrated and become unstable. Physician #3 additionally stated there could be a lot of electrolyte imbalances, which could lead to downstream multiorgan failure.”

“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: 42601 Based on document reviews and interviews, the hospital was unable to follow their policy and provide a medical screening examination with the capability of the hospital’s Emergency Department for a patient who was seeking care in one (1) of twenty (20) ED patient records reviewed (Patient #1). Finding: The hospital’s “Management of Patients Presenting with Potential Emergency Medical Conditions in Compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA) and Maine’s Hospital Licensing Rules” policy, last revised 11/22, states in part, “ ... If a person, including a minor, comes or presents to a MGMC ED (“ED”) (i.e. at either the ACH, or the TCH) and (i) the person requests examination or treatment for a medical condition, (ii) a request for examination or treatment for a medical condition is made on the person’s behalf by anyone accompanying the person, or (iii) it is evident to a prudent layperson observer that based on the person’s appearance or behavior the person needs examination or treatment for a medical condition, qualified ED clinical staff (as defined in Section III(A)(2) below) shall provide an appropriate medical screening examination within the capability of the ED, including ancillary services routinely available to the ED, to determine whether an emergency medical condition exists. If a patient comes to a MGMC ED and a request is made on the patient’s 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, qualified ED clinical staff will perform a medical screening examination medically appropriate for a patient presenting in that manner to determine that the patient does not have an emergency medical condition ... “. On 12/07/2023, MaineGeneral Medical Center self-reported a possible EMTALA violation stating, in part, “[Patient #1] came into the Emergency Department to be seen for a “miscarriage”. The registrar told the patient that because she was a minor, consent by a parent would be needed. The patient said that she did not want to contact the parent(s) and left the building. The registrar did NOT tell the patient that she could not be seen or treated.” On 01/03/2024 at 12:35 PM, the patient registration employee who was involved with Patient #1 on 12/05/2023 was interviewed. She stated that [Patient #1] came in and said she was possibly having a miscarriage, I usually ask their age ... she told me she was seventeen (17) years old and I told her we need consent. At that point, I didn’t know her name. She said no and walked out. I offered her a nurse and she walked out.” MaineGeneral Medical Center identified the potential violation, self-reported the event, and put in measures to ensure that registration staff did not pose a question that could possibly deter a patient in the future from seeking care, which included a review of facility Emergency Medical Treatment and Active Labor Act (“EMTALA”) policies, online EMTALA training for staff, and in-person EMTALA reviews with Emergency Department staff. At the time of the on-site survey, surveyors determined, through observation, document reviews, and interviews, that MaineGeneral Medical Center was in compliance, but previously out of compliance with 42 CFR, Part 489, Responsibilities of Medicare Participating Hospitals in Emergency Cases. On 01/03/2024 at 10:56 AM, the Chief Compliance Officer was interviewed. She stated, in part, that the registration person was re-educated as she has only been here a few months. We have a new training for staff that may be exposed. It will be for anyone at the offsite practices, security and staff at the hospital and other campus’. All ED and Ob/Gyn staff have intensive EMTALA training.”

“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: 42601 Based on document reviews and interviews, the hospital was unable to provide a medical screening examination with the capability of the hospital’s Emergency Department for a patient who was seeking care in one (1) of twenty (20) ED patient records reviewed (Patient #1). Finding: The hospitals “Management of Patients Presenting with Potential Emergency Medical Conditions in Compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA) and Maine’s Hospital Licensing Rules” policy, last revised 11/22, states in part, “ ... If a person, including a minor, comes or presents to a MGMC ED (“ED”) (i.e. at either the ACH, or the TCH) and (i) the person requests examination or treatment for a medical condition, (ii) a request for examination or treatment for a medical condition is made on the person’s behalf by anyone accompanying the person, or (iii) it is evident to a prudent layperson observer that based on the person’s appearance or behavior the person needs examination or treatment for a medical condition, qualified ED clinical staff (as defined in Section III(A)(2) below) shall provide an appropriate medical screening examination within the capability of the ED, including ancillary services routinely available to the ED, to determine whether an emergency medical condition exists. If a patient comes to a MGMC ED and a request is made on the patient’s 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, qualified ED clinical staff will perform a medical screening examination medically appropriate for a patient presenting in that manner to determine that the patient does not have an emergency medical condition ... “. On 12/07/2023, MaineGeneral Medical Center self-reported a possible EMTALA violation stating, in part, “[Patient #1] came into the Emergency Department to be seen for a “miscarriage”. The registrar told the patient that because she was a minor, consent by a parent would be needed. The patient said that she did not want to contact the parent(s) and left the building. The registrar did NOT tell the patient that she could not be seen or treated.” On 01/03/2024 at 12:35 PM, the patient registration employee who was involved with Patient #1 on 12/05/2023 was interviewed. She stated that [Patient #1] came in and said she was possibly having a miscarriage, I usually ask their age ... she told me she was seventeen (17) years old and I told her we need consent. At that point, I didn’t know her name. She said no and walked out. I offered her a nurse and she walked out.” MaineGeneral Medical Center identified the potential violation, self-reported the event, and put in measures to ensure that registration staff did not pose a question that could possibly deter a patient in the future from seeking care, which included a review of facility Emergency Medical Treatment and Active Labor Act (“EMTALA”) policies, online EMTALA training for staff, and in-person EMTALA reviews with Emergency Department staff. At the time of the on-site survey, surveyors determined, through observation, document reviews, and interviews, that MaineGeneral Medical Center was in compliance, but previously out of compliance with 42 CFR, Part 489, Responsibilities of Medicare Participating Hospitals in Emergency Cases. On 01/03/2024 at 10:56 AM, the Chief Compliance Officer was interviewed. She stated, in part, that the registration person was re-educated as she has only been here a few months. We have a new training for staff that may be exposed. It will be for anyone at the offsite practices, security and staff at the hospital and other campus’. All ED and Ob/Gyn staff have intensive EMTALA training.”