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Based on records reviewed and interviews, the Condition of Participation for Governing Body was not met as evidenced by the failure to ensure a system was in place to verify that all staff (including physicians and staff that provide care to pediatric patients) had completed mandatory abuse reporting training, were competent in abuse reporting knowledge and understood their responsibilities under the State of Maine statutes for immediate reporting to the Department. Additionally, the Governing Body failed to ensure that policies, procedures and processes were sufficiently evaluated, revised and amended to correct the 2016 State Licensure violation regarding the failure to immediately report an allegation of abuse. The Governing Body failed to ensure the hospital protected patient rights by failing to immediately report and thoroughly investigate an October 2018 allegation of abuse, and failing to ensure the hospital had abuse policies and procedures that were in compliance with state and federal requirements, including a hospital process for investigating allegations of abuse that occur within the hospital. The Governing Body failed to ensure that existing policies and procedures were revised and updated timely, and failed to ensure that patient rights were protected, that patients and their decision makers were fully involved in the care planning process and that patients and their decision makers are informed of the risks and benefits before utilization of medical devices whenever possible. The Governing Body failed to ensure that the hospital had a process or system to verify that outside agencies being considered for contractual arraignments were in compliance with State of Maine statutes and federal regulations prior to contracting with those agencies. The Governing Body failed to ensure the Plan of Correction for the 2016 failure to report abuse citation was sufficiently monitored by the Quality Assurance and Performance Improvement Committee (QAPI), to ensure the plan of correction resulted in a sustainable and permanent solution to the deficient practice cited.

Findings:

1. The Governing Body failed to ensure the hospital had a system in place to track and ensure that all medical staff completed and understood their responsibilities for mandatory reporting of abuse or neglect. In an interview with the Director of Accreditation, Regulatory Affairs and Patient Relations on December 21, 2018 surveyors were told that the hospital does provide a video training on abuse for physicians, but that the hospital does not have a process for tracking and ensuring that the physicians completed the course. The surveyor expressed concern that the training does not contain a mechanism to ensure that the physicians know and understand the requirement to immediately report to the Department of Health and Human Services. In a telephone interview on 12/21/18 at 11:48 AM with Physician #1 the surveyor asked Physician #1 what he/she would do if a patient in the hospital made an allegation of abuse that occurred within the hospital to him/her, Physician #1 stated, " I don't know what I'd do. I'd tell the Attending Physician in charge but beyond that I don't know."

In an interview with Physician #2 on 12/20/18 at 2:38 PM, surveyors were informed that the physician was unaware of any internal hospital investigation process for a patient who alleges abuse and that it appears there is a reliance on the physician to determine if a patient's statement has any validity to it based on the patient's mental status or level of cognition or confusion. The physician described that, while it is not uncommon for someone with cognition issues or confusion to misunderstand and claim they were abused when in fact the they were being provided appropriate care for incontinence or wound cleaning, it is difficult for a physician to state conclusively that no abuse occurred as the physician focuses on the patient and his/her medical needs and does not look into who may or may not have been with the patient.

2. Standard: §482.12(e) Contracted Services also known as A0083 - The Governing Body failed to ensure a system was in place to verify that Temporary Nurse Agencies were registered to operate in the State of Maine prior to contracting with those agencies. See A0083 for details.

3. The Governing Body has an overall responsibility for the services furnished at the hospital which includes the review and approval of the hospital's Performance and Patient Safety Improvement Plans (QAPI program). The Governing Body has failed to provide oversight of the QAPI programs within the hospital to ensure that the plan of correction for the failure to report abuse in 2016 resolved the deficient practice and was a sustainable solution. See A0263 for details.

4. The Governing Body failed to ensure that hospital policies and procedures were updated timely to ensure compliance with relevant mandatory reporting abuse requirements (see A0115, A0144, and A0145 for details). The hospital failed to conduct abuse and neglect reporting training for all staff who have potential unsupervised access to patients and who could witness, hear, or be told allegations of abuse themselves, or by patients or patient family and visitors. This finding was confirmed in an interview with the Director of Accreditation, Regulatory Affairs and Patient Relations on 12/21/18, who stated, "Dietary, housekeeping and maintenance staff are not considered mandatory reporters and do not go through mandatory reporter training."

The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

Based on review of clinical contracts and interviews it was determined that the governing body failed to ensure that there was oeversight of all Temporary Nurse Agency contracts to ensure the agencies were registered and legally able to provide services in the State of Maine.

Findings include:

A review of eight (8) Temporary Nurse Agency staffing contracts for the hospital Fiscal Year (October 1, 2017 to September 30, 2018) revealed that 3 of the 8 staffing agencies that the hospital chose to contract with had not met the State of Maine statutory requirement to register as a Temporary Nurse Agency in the State of Maine. This finding was reviewed with the Director of Accreditation, Regulatory Affairs and Patient Relations on December 21, 2018 who stated that it was the Human Resources Department's responsibility to validate the TNAs were approved to operate in the State of Maine.

The hospital failed to ensure all staff, including physicians, were trained and competent regarding the mandatory reporting, and investigation of allegations of abuse, that patients or their decision makers were truly involved in the plan of care, and that all physicians had completed training on restraints prior to ordering restraints in the hospital. The cumulative effect of the deficient practice, in combination with the fact that the failure to immediately report an allegation of abuse is a repeat deficiency as the hospital was found in violation of the State of Maine Rules for the Licensing of Hospitals and 22 MRSA Chapter 1071 §4011-A for failure to immediately report an allegation of abuse on 11/30/16, resulted in noncompliance with this Condition of Participation.

Findings:

1. The Governing Body failed to ensure that all physicians complete training and education in the hospital's restraint policies and procedures before ordering the application of restraints for a patient (see A-0199 and A0176 for details).
2. The Governing Body failed to ensure that the hospital had established a clear process, policy, or procedure for immediately reporting any allegation of abuse or neglect, and conducting thorough internal investigations of such allegations, while ensuring patient protection. This failure resulted in the hospital's failure to conduct a thorough investigation of an allegation of abuse, and failure to identify quality of care and patient safety process issues (see A-0144 for details).
3. The Governing Body failed to ensure that its policies regarding mandatory reporting of abuse and neglect were revised and in compliance with State and Federal requirements, that all staff were trained and competent in the abuse or neglect mandatory reporting requirements, and that the hospital had an internal investigative process that ensures immediate reporting and patient protections during an internal investigation (see A-0145 for details).
4. The Governing Body failed to ensure that the hospital's grievance policy was in full compliance with regulatory requirements, and failed to ensure an allegation of abuse was appropriately entered and tracked, thoroughly investigated, and reports and notifications made consistent with the hospital's policy and regulatory and statutory requirements (see A-0118, A-0144 and A-0145 for details).
The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

The hospital failed to process a grievance for prompt resolution for 1 of 10 grievance records reviewed, and failed ensure staff followed the hospital's grievance process.

Finding:

While conducting a complaint survey between 12/19/18 and 12/27/18, surveyors reviewed a sample of 10 grievance cases, and noted that one of the cases was an allegation of abuse that had been classified in the hospital grievance system as a "Public Submission." Surveyors requested the hospital's current policy regarding grievances and were provided with a hospital policy titled "Patient Complaints and Grievances" with revised date of 12/3/12. The policy did not contain a definition of a "Public Submission" nor did it address what the process is for handling something classified as a "Public Submission." On 12/20/18, in an interview with the Director of Accreditation, Regulatory Affairs, and patient Relations, surveyors were informed that this allegation of abuse should have been classified as a grievance as it met the criteria of grievance and when she requested that the Patient Relations staff enter it into the system she had instructed that it be entered as a grievance. The Director of Accreditation, Regulatory Affairs, and Patient Relations stated that there was no definition of a "Public Submission" in any hospital policy or procedure related to grievances or the hospital's grievance process.
On December 20, 2018 at 3:15 PM, surveyors conducted an interview with the Hospital Director of Security, the Director of Accreditation, Regulatory Affairs, and Patient Relations, and a Project Manager regarding the allegation of abuse that was received and classified as a "Public Submission" in the hospital's complaint and grievance database. The hospital Director of Security stated that he had received a call from a law enforcement agency on 12/11/18 advising him that they (the law enforcement agency) had received a complaint about an alleged incidence of abuse that occurred at the hospital. The Hospital Director of Security stated that he then informed the Director of Accreditation, Regulatory Affairs, and Patient Relations. Surveyors were then informed by the Director of Accreditation, Regulatory Affairs, and Patient Relations that she conducted a chart review of the patient involved and noted a particular nurse note which indicated that the patient was confused and that the patient had stated he/she "is being 'Abused'." The Director of Accreditation, Regulatory Affairs, and Patient Relations then directed the staff in the Patient Relations unit to enter this into the hospital complaint and grievance database for follow up. The hospital grievance system denoted that the hospital was notified of the allegation of abuse on 12/11/18, and it was not entered into the hospital grievance system until 12/12/18. On 12/12/18 at 9:01 AM, a Patient Relations Representative sent a follow up action request to the Director of Nurses for the unit on which this was alleged to have occurred. In that follow up request, the Unit Director of Nurses was told that a thorough investigation of the events must be conducted and then told to interview one staff nurse regarding her chart note and entries on a certain date and the circumstances around that note. On 12/12/18 at 9:47 AM, the Director of Nurses for the unit involved entered a note in response to the request from Patient Relations advising that she conducted a phone interview with the nurse and noted that the patient involved appeared "confused/vague, disoriented" and that the patient arrived "soiled" and the "RN advised her that they needed to clean him/her up, patient stated not wanting to be cleaned up, but due to confusion the RN and another staff member cleaned him/her." The surveyors asked why this allegation was never reported and why a thorough investigation was not conducted. The Director of Accreditation, Regulatory Affairs, and Patient Relations stated that she had conducted a review of this and consulted with one of the Director of Nurses for the unit involved regarding the clinical aspects of the allegation and determined that there was no abuse but rather a confused patient who did not understand staff were trying to help him/her. The Director of Accreditation, Regulatory Affairs, and Patient Relations stated since there was no abuse, there was nothing to report. When asked if there was any follow up with the law enforcement agency that reported this allegation on 12/11/18, surveyors were informed, "no, we have called and left messages but we have not connected with them yet." On 12/20/18 at 8:45 AM, surveyors conducted a phone interview with the law enforcement official who had notified the hospital on 12/11/18 of the allegation and were told that he was still awaiting a call back from the hospital so he could gather the preliminary and background information he needed to proceed.
Surveyors conducted a telephone interview on 12/21/18 at 11:48 AM with Physician #1 who spoke to the patient on the afternoon/evening the incident was alleged to occur, he/she stated that he/she did recall that "the patient was delirious from the ICU setting and that the nurse said the patient had brought up an allegation of sexual assault in the ICU." When asked to clarify if the nurse told him/her this or if the patient may have told him this and the physician stated, "I don't recall the patient making any statements directly to me and I heard the statement tangentially as I was talking to him/her; the way we left it was that the nurse would enter a note and it would work its way through the system." When asked what he/she would do if a patient in the hospital made an allegation of abuse that occurred within the hospital to him/her, Physician #1 stated, "Honestly this is the only time this has ever happened and I don't know what I'd do. I'd tell the Attending Physician in charge but beyond that I don't know."
On 12/20/18 at 2:40 PM surveyors conducted a phone interview with the nurse who received the patient on the date the incident was alleged to have occurred. The nurse recalled the patient appeared to be confused and yelling and that he/she was extremely upset at being transferred. The nurse stated that patient was resistive to care and arrived incontinent. The nurse stated that she (the nurse) was assisted by a Patient Care Technician in cleaning and changing the patient and that despite several attempts to reassure the patient about the need to clean and change him/her, the patient was resistive and didn't want them to clean him/her and didn't understand that they were trying to help him/her.
On 12/27/18, surveyors were informed by Director of Accreditation, Regulatory Affairs, and Patient Relations that this case was an abuse grievance case, and that the hospital was notified of on 12/11/18, and the hospital's grievance should have been followed and a more thorough investigation should have been completed.

The Governing Body failed to ensure that hospital had established a clear process, policy, or procedure for immediately reporting, and conducting thorough internal investigations while ensuring patient protection of any allegation of abuse or neglect. This failure resulted in the hospital's failure to conduct a thorough investigation of an allegation of abuse and failure to identify quality of care and patient safety process issues.

Findings:

While conducting a complaint survey between 12/19/18 and 12/27/18, surveyors reviewed a sample of 10 grievance cases, and noted that one of the cases was an allegation of abuse that had been classified in the hospital grievance system as a "Public Submission." Surveyors requested the hospital's current policy regarding grievances and were provided with a hospital policy titled "Patient Complaints and Grievances" with revised date of 12/3/12. The policy did not contain a definition of a "Public Submission" nor did it address what the process is for handling something classified as a "Public Submission." On 12/20/18, in an interview with the Director of Accreditation, Regulatory Affairs, and Patient Relations, surveyors were informed that this allegation of abuse should have been classified as a grievance as it met the criteria of grievance and when she/he requested that the Patient Relations staff enter it into the system she/he had instructed that it be entered as a grievance. The Director of Accreditation, Regulatory Affairs, and Patient Relations stated that there was no definition of a "Public Submission" in any hospital policy or procedure related to grievances or the hospital's grievance process.
On 12/20/18 at 3:15 PM, surveyors conducted an interview with the Hospital Director of Security, the Director of Accreditation, Regulatory Affairs, and Patient Relations, and a Project Manager regarding the allegation of abuse that was received and classified as a "Public Submission" in the hospital's complaint and grievance database. The hospital Director of Security stated that he had received a call from a law enforcement agency on 12/11/18 advising him that they (the law enforcement agency) had received a complaint about an alleged incidence of abuse that occurred at the hospital. The Hospital Director of Security stated that he then informed the Director of Accreditation, Regulatory Affairs, and Patient Relations. Surveyors were then informed by the Director of Accreditation, Regulatory Affairs, and Patient Relations that she conducted a chart review of the patient involved and noted a particular nurse note which indicated that the patient was confused and the patient had stated he/she "is being 'Abused'." The Director of Accreditation, Regulatory Affairs, and Patient Relations then directed the staff in the Patient Relations unit to enter this into the hospital complaint and grievance database for follow up. The hospital grievance system denoted that the hospital was notified of the allegation of abuse on 12/11/18 and it was not entered into the hospital grievance system until 12/12/18. On 12/12/18 at 9:01 AM, a Patient Relations Representative sent a follow up action request to the Director of Nurses for the unit on which this was alleged to have occurred; in that follow up request, the Unit Director of Nurses was told that a thorough investigation of the events must be conducted and then told to interview one staff nurse regarding her chart note and entries on a certain date and the circumstances around that note. On 12/12/18 at 9:47 AM, the Director of Nurses for the unit involved entered a note in response to the request from Patient Relations advising that she conducted a phone interview with the nurse and noted that the patient involved appeared "confused/vague, disoriented" and that the patient arrived "soiled" and the "RN advised him/her that they needed to clean him/her up, patient stated not wanting to be cleaned up, but due to confusion the RN and another staff member cleaned him/her." The surveyors asked why this allegation was never reported and why a thorough investigation was not conducted. The Director of Accreditation, Regulatory Affairs, and Patient Relations stated that she had conducted a review of this and consulted with one of the Director of Nurses for the unit involved regarding the clinical aspects of the allegation and determined that there was no abuse but rather a confused patient who did not understand staff were trying to help him/her. The Director of Accreditation, Regulatory Affairs, and Patient Relations stated since there was no abuse, there was nothing to report. When asked if there was any follow up with the law enforcement agency that reported this allegation on 12/11/18, surveyors were informed, "no, we have called and left messages but we have not connected with them yet." On 12/20/18 at 8:45 AM, surveyors conducted a phone interview with the law enforcement official who had notified the hospital on 12/11/18 of the allegation and were told that she/he was still awaiting a call back from the hospital so she/he could gather the preliminary and background information she/he needed to proceed.
Surveyors conducted a telephone interview on 12/21/18 at 11:48 AM with Physician #1 who spoke to the patient on the afternoon the incident was alleged to occur, he/she stated that he/she did recall that "the patient was delirious from the ICU setting and that the nurse said the patient had brought up an allegation of sexual assault in the ICU." When asked to clarify if the nurse told him/her this or the patient the physician stated, "I don't recall the patient making any statements directly to me and I heard the statement tangentially as I was talking to him/her; the way we left it was that the nurse would enter a note and it would work its way through the system." When asked what he/she would do if a patient in the hospital made an allegation of abuse that occurred within the hospital to him/her, Physician #1 stated, "Honestly this is the only time this has ever happened and I don't know what I'd do. I'd tell the Attending Physician in charge but beyond that I don't know."
On 12/20/18 at 2:40 PM surveyors conducted a phone interview with the nurse who received the patient on the date the incident was alleged to have occurred. The nurse recalled the patient appeared to be confused and yelling and that he/she was extremely upset at being transferred. The nurse stated that patient was resistive to care and arrived incontinent. The nurse stated that she (the nurse) was assisted by a Patient Care Technician in cleaning and changing the patient and that despite several attempts to reassure the patient about the need to clean and change him/her, the patient was resistive and didn't want them to clean him/her and didn't understand that they were trying to help him/her.
A review of the medical record denoted a nurse's note dated 10/24/18 which stated, "This RN and C.N.A. washed patient at this time. Patient became very upset while being washed and while RN placed Purewick on patient for incontinence, patient stating he/she is being 'Abused'."
Telephone interviews were conducted with RN#2 on 12/21/18 and 1/2/19; RN#2 had taken care of Patient A while he/she was in the ICU unit. RN#2 stated she did not recall the patient making any allegation of abuse in her presence. During the interview, surveyors asked for clarification regarding a device noted in the medical record as a "Purewick." RN#2 stated that the Purewick is used for patient incontinence and that the nurse does not need a doctor's order to apply and use the device. RN#2 stated it is placed in the appropriate area of the perineum and hooked to suction to wick away urine from patients with incontinence. RN#2 stated that a nurse does an online in-service training with a link to a web based video on the device. RN#2 stated that Patient A did not have a Purewick device or an internal catheter in use while RN#2 was Patient A's nurse.
On 1/2/19 surveyors requested copies of the hospital policy and procedures for use and application of the Purewick device which the 10/24/18 nurses note states was applied to Patient A. Surveyors were provided with the hospital's 1-page training document (which contained a link to a web based video for instructions). Surveyors also contacted the manufacturer and obtained information from the manufacturer which stated, "Precautions: Not recommended for patients who are agitated, combative, or uncooperative." On 1/2/19, surveyors were advised by the Director of Accreditation, Regulatory Affairs, and Patient Relations that the Purewick does not require a physician's order and it is considered covered under the hospital's policy titled "Prevention of Catheter Acquired Associated Urinary Tract Infections (CAUTI)" which she provided a copy of the policy for reference. The surveyors could find no reference to the utilization and application of the Purewick in the hospital policy provided, and noted that the hospital policy provided does not define or address insertion or utilization of external catheters, only indwelling catheters are addressed in the CAUTI policy.
The surveyor asked if there was any competency evaluation by nursing staff to ensure they knew the contraindications and precautions and on when to not use the Purewick device. The Director of Accreditation, Regulatory Affairs, and Patient Relations stated in an email received on 1/2/19 that there is no competency assessment or process for testing nurses prior to their approval to use the Purewick. The nurses complete the hospital's training (the hospitals Express Inservice) which includes an instructional video and then they may utilize the device. The surveyor read the manufacturer precautions and noted that the utilization of the Purewick for Patient A appears to be contrary to the manufacturer recommendations, based on interviews and records which indicated the patient was confused and resistive to care. The Director of Accreditation, Regulatory Affairs, and Patient Relations had no additional information regarding the use of Purewick in this case.

The facility failed to ensure that its policies regarding abuse and neglect mandatory reporting were revised and in compliance with State and Federal requirements, that all staff were trained and competent in the abuse or neglect mandatory reporting requirements, and that it had an internal investigative process that ensure immediate reporting and patient protections during an internal investigation.

Findings:

1. On 12/19/18 and 12/20/18, the surveyor reviewed 10 patient grievance cases, three of which were related to abuse. One of the grievances cases was coded as a "Public Submission", which was not defined by facility policy; on December 27, 2018, the Director of Accreditation, Regulatory Affairs, and Patient Relations provided surveyors with a "Working Definition of Public Submission" that defined this as "An issue that is presented by someone not affiliated with the hospital ...This category refers to the manner in which the case comes in and then can be reclassified appropriately as the case proceeds." On 12/20/18, in an interview with the Director of Accreditation, Regulatory Affairs, and Patient Relations confirmed that there is no reference to "Public Submission" in the hospital's grievance policy and that this case was an abuse grievance case and should have been categorized as a grievance and the hospital's grievance process should have been followed. At the time of the interview, the surveyor requested a copy of the hospital's written procedure for investigating allegations of abuse and neglect, including methods to protect patients from abuse during investigations of allegations, how the hospital substantiates allegations of abuse and neglect, and the appropriate agencies that are notified in accordance with State and Federal laws regarding incidences of abuse and neglect.

On 12/21/18 at 9:15 AM, in an interview with the Director of Accreditation, Regulatory Affairs, and Patient Relations and a Project Manager, the surveyor followed up, again requesting a copy of the hospital's written procedure for investigating allegations of abuse and neglect, and was informed the hospital does not have a formal process or written procedure for investigating allegations of abuse and neglect to include appropriate agencies to be notified, thus the appropriate agencies were not contacted by the facility. At the time of the interview, the surveyor confirmed the finding with the Director of Accreditation, Regulatory Affairs, and Patient Relations

2. The hospital did not have a sufficient process for tracking abuse and neglect training completion of all staff or ensuring staff comprehension and competence following completion of the training. A review of the hospital's abuse and neglect training for nurses and Certified Nursing Assistants (C.N.A.) was conducted and it was noted as lacking clarity regarding the State requirements for individual staff to immediately report suspected abuse and neglect requirements to the State of Maine Department of Health and Human Services. Surveyors observed a training video that the hospital provides for physicians and noted that it also failed to clarify the individual responsibilities to immediately report suspected abuse or neglect to the State of Maine Department of Health and Human Services. Surveyors requested documentation of staff completion and competency evaluations for abuse and neglect reporting requirements and were only provided records for nursing and C.N.A staff. In an interview with the Director of Accreditation and Regulatory Affairs, surveyors were informed that the hospital has no system or process in place to track physician completion or comprehension and competence regarding abuse and neglect reporting; surveyors were informed, "it's on the honor system and we cannot tell who actually completed the video training and who did not." Surveyors conducted interviews with hospital physicians regarding abuse and neglect reporting training and the process for reporting any allegations of abuse that may have occurred in the hospital or any of its facilities that they, as physicians, may have heard from patients. All 3 physicians interviewed stated they were unsure of specific training in abuse reporting, all indicated they were sure they probably completed training at some point but could not recall the hospital process; all 3 stated they would inform the Director of Accreditation, Regulatory Affairs, and Patient Relations and Risk Management and that it would then go through appropriate channels to be addressed. When asked if they would immediately report to any agency or department outside of the hospital, all 3 physicians reported that they would not do so.
In an interview with a physician on 12/20/18 at 2:38 PM, surveyors were informed that the physician was unaware of any internal hospital investigation process for a patient who alleges abuse and that it appears there is a reliance on the physician to determine if a patient's statement has any validity to it based on the patient's mental status or level of cognition or confusion. The physician described that, while it is not uncommon for someone with cognition issues or confusion to misunderstand and claim they were abused when in fact the they were being provided appropriate care for incontinence or wound cleaning, it is difficult for a physician to state conclusively that no abuse occurred as the physician focuses on the patient and his/her medical needs and does not look into who may or may not have been with the patient.

Based on records review and interviews, the facility failed to ensure training was completed by a physician authorizing restraint orders according to hospital policy for 1 of 5 restraint records reviewed.

According to Maine Medical Center - Institutional Policy Manual - Policy Title: Restraint:
"9. A trained licensed independent practitioner (LIP) or his or her designee must issue the order to initiate restraint or seclusion."
"18. All staff who are involved with the application of a restraint, implementation of seclusion, providing care for a patient in restraint or seclusion, or with assessing and monitoring the condition of the restrained or secluded patient, will receive training based on their duties and responsibilities, initially (prior to performing restraint application) and on an ongoing basis by individual site polity. (MMC Appendix C: Education Requirements)"

Finding:

On 12/19/18 and 12/20/18, the surveyor reviewed 5 restraint records, one of which contained a physician order for a non-violent restraint used for medical purposes to protect the patient. The restraint ordered 12/6/18 at 5:55 AM was ordered by a physician who had not completed required seclusion and restraint training. On 12/21/18 at 9:15 AM, in an interview with the Director of Accreditation, Regulatory Affairs, and Patient Relations, she confirmed the physician did not complete required seclusion and restraint training prior to ordering the restraint on 12/6/18.

The facility failed to ensure required seclusion and restraint training was completed by a physician for 1 of 5 restraint records reviewed.

According to Maine Medical Center - Institutional Policy Manual - Policy Title: Restraint:
"9. A trained licensed independent practitioner (LIP) or his or her designee must issue the order to initiate restraint or seclusion."
"18. All staff who are involved with the application of a restraint, implementation of seclusion, providing care for a patient in restraint or seclusion, or with assessing and monitoring the condition of the restrained or secluded patient, will receive training based on their duties and responsibilities, initially (prior to performing restraint application) and on an ongoing basis by individual site polity. (MMC Appendix C: Education Requirements)"

Finding:

On 12/19/18 and 12/20/18, the surveyor reviewed 5 restraint records, one of which contained a physician order for a non-violent restraint used for medical purposes for patient protection. The restraint order dated 12/6/18 at 05:55 AM was ordered by a physician who had not completed required seclusion and restraint training. On 12/21/18 at 9:15 AM, in an interview with the Director of Accreditation and Regulatory Affairs, he/she confirmed the physician did not complete required seclusion and restraint training prior to ordering the restraint on 12/6/18, and the surveyor confirmed the finding.

Based on records reviewed and interviews, the Condition of Participation (CoP) for Quality Assurance Performance Improvement (QAPI) was not met as evidenced by the hospital's failure to have a system in place to ensure that the plan of correction for the 2016 failure to report suspected abuse had sufficiently corrected the deficient practice and maintained compliance with requirements, and the failure to ensure an effective system was in place to monitor contracted temporary nurse agencies and ensure they were in compliance with State of Maine registration requirements.

Findings:

1. Standard §§482.21(a)(1), 482.21(a)(2), 482.21(c)(2), & 482.21(e)(3) Patient Safety, Medical Errors & Adverse Events also known as A-0286- The hospital QA Prgram must failed to provide evidence of an ongoing program that shows measurable improvements based on the repeat deficient practice for failure to immediately report an allegation of abuse. See A0286 for details.

2. Standard: §482.21 Condition of Participation: Quality Assessment and Performance Improvement Program-also known as A0308 -The QA Program failed to ensure quality of contracted services based on the lack of a system in place to verify that Temporary Nurse Agencies were registered to operate in the State of Maine prior to contracting with those agencies. See A0308 for details

The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

Based on Interviews and documents reviewed, the hospital failed to ensure that a submitted and approved plan of correction related to a 2016 citation for failure to report suspected abuse was implemented and monitored for 1 of 1 previously cited issues. This failure resulted in a repeat deficiency.

Findings:

During a complaint survey with an onsite investigation conducted from 12/19/18 through 12/27/18, the hospital was found to be in noncompliance with standard 482.13(c)(3) Patient Rights: (A-0145) and one of the issues identified and cited involved the hospital physician and his/her staff's failure to immediately report an occurrence of suspected abuse by non-hospital staff which was witnessed by hospital staff in the hospital facility. On December 15, 2016, the hospital submitted a notification to the State Agency that it had corrected the deficient practice.

During this survey, the facility was found again to be in noncompliance with 482.13(c)(3) Patient Rights (A-0145) as evidenced by the following:

A.A review of the hospital policies and procedures for reporting suspected abuse and neglect did not include clear guidance regarding the requirement to immediately report to the Department of Health and Human Services.

B. A review of the hospital abuse and neglect training programs identified that they did not provide clear guidance regarding the requirement for staff to immediately report to the Department of Health and Human Services. Additionally, the hospital failed to train all staff and had no evidence to indicate that dietary staff, housekeeping staff, maintenance staff, or physicians had completed any training in mandatory abuse reporting. In an interview with the Director of Accreditation, Regulatory Affairs and Patient Relations on December 21, 2018 surveyors were told that the hospital does not train dietary, housekeeping, and maintenance staff as they do not consider them to be mandated reporters under the Maine State Statutes. Surveyors were also informed that the physicians do participate in a video training program but that the hospital does not have a process for tracking and ensuring that the physicians completed the course.

C. Surveyors requested a list of all staff who work in the hospital area that was subject to the 2016 citation for failure to report abuse and any evidence to indicate that those staff had completed the statutorily required abuse reporting training. In an interview with the Director of Accreditation, Regulatory Affairs and Patient Relations on 12/27/18 at 10:10 AM, surveyors were told that the hospital does not have a process to track and ensure that the physicians have completed the pediatric mandatory reporting of suspected abuse training.

D. Surveyors requested a copy of the most current policy and procedure for reporting suspected abuse that was in effect and readily available to staff at the time of this survey and any evidence to demonstrate that the hospital Quality Assurance Committee had monitored and evaluated the plan of correction implementation and corrective actions for the 2016 citation to ensure they were effective and would sustain compliance. Surveyors were provided with a copy of a policy titled: "Reporting of Suspected Child Abuse or Neglect or Drug Affected Baby." This policy was noted as having a development date of June, 1999, with a review date of 9/27/04 and the most recent date was noted as "Committee(s) Approval and Date: Institutional Policy Review: 6/23/08, 11/23/09." Surveyors were informed that the policy provided was the most current policy; surveyors were informed that this policy has been revised but is not published or available to staff until it has completed legal review and been signed off by one of the Vice President's which has yet to be completed. In an interview with the Director of Accreditation, Regulatory Affairs and Patient Relations on 12/19/18 at 2:04 PM, she verified that the policy provided (which predated the 11/30/16 determination of noncompliance) is the most current policy in effect, and she verified that the policy provided does not address the requirement for immediate mandatory reporting to the Department.

Based on record review and interview, the hospital Quality Assurance Program failed to ensure that contracted staffing was included in its review as evidenced by 3 out of 8 Temporary Nurse Agencies (TNA) which the hospital contracted with for staffing services that were not in compliance with the Maine State statutes for TNA registration (22 MRSA Chapter 417 §2131).

Finding includes:

Several of the hospital contracts for the Fiscal Year (October 1, 2017 to September 30, 2018) were reviewed, including staffing contracts. A review of the State of Maine Temporary Nurse Agency Registry determined that 3 of the 8 staffing agencies that the hospital chose to contract with had not met the State of Maine statutory requirement to register as a Temporary Nurse Agency in the State of Maine. This finding was reviewed with the Director of Accreditation, Regulatory Affairs and Patient Relations on December 21, 2018 who stated that it was the Human Resources Department's responsibility to validate the TNAs were approved to operate in the State of Maine.