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Based on document reviews and interviews, it was determined that the Condition of Participation ("CoP") for Organizational Structure was not met as evidenced by the Governing Body's failure to provide oversight. This failure was evidenced by the following: The failure to ensure hospital staff to implemented policies and procedures related to assessment and treatment of psychiatric patients.

Findings:

The Governing Body has failed to provide oversight of the hospital as evidenced by the following:

Condition: §485.627 CoP: Organizational Structure, also known as C-0960 - Based on document review and interviews, it was determined that the Condition of Participation for Organizational Structure was not met as evidenced by the hospital's failure to ensure the implementation of policies and procedures for twenty-nine (29) of twenty-nine (29) records reviewed, with patients who were seen with psychiatric complaints in the Emergency Department. See C-0962 for details.

Standard: §485.627(a) Governing Body or Responsible Individual, also known as C-0962 - Based on document reviews, observations and interviews, the Governing Body failed to ensure hospital policies were implemented in relation to two (2) required assessments for twenty-nine (29) of twenty-nine (29) sampled records for patients seen in the hospital for psychiatric complaints. In addition, the Governing Body failed to ensure hospital policies were implemented in relation to placing high risk suicidal patients in paper scrubs for three (3) of three (3) patients who were assessed as high risk suicidal patients (Patient #5, #8 and #31). See C-0962 for details.

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

Based on document reviews, and interviews, the Governing Body failed to ensure hospital policies were implemented in relation to two (2) required assessments for twenty-seven (27) of twenty-seven (27) patients seen in the hospital for psychiatric complaints (Patient #1 - #4A and #4B, #5B, #5C - #9, #12, #15 - #17, #23 - #26B, #28, and #31 - #39). In addition, the Governing Body failed to ensure hospital policies were implemented in relation to placing high risk suicidal patients in paper scrubs for three (3) of three (3) patients who were assessed as high risk suicidal patients (Patient #5, #8 and #31).

Findings:

1. The hospital's policy titled, "Psychiatric and Violent Patients", last reviewed 1/2022, indicates, in part, the following: "The Colombia score will be used at triage to determine suicide risk for all patients presenting with any psychiatric complaints. Patients risk will be classified using this scale in conjunction with provider determination...In the event that the interviewer suspects that a patient is at risk of harming himself or is expressing suicidal ideation, the "Suicide Risk Screening Tool", should be completed".

This policy was not implemented as evidenced by the following:

From 6/27/2022 through 6/30/2022, surveyors reviewed a total of twenty-nine (29) records for patients seen in the hospital for psychiatric complaints. There was no evidence in the records that the required assessments were completed.

On 6/28/2022 at 10:42 AM, the Emergency Department ("ED") Director confirmed that the policy requires both the Columbia-Suicide Severity Rating Scale ("C-SSRS") and the Suicide Risk Screening Tool ("SRST"), if the patient is at risk of harming himself or is expressing suicidal ideation.

On 6/28/2022 at 12:19 PM, RN #1 was interviewed in relation to the required assessments. When asked if she conducted the SRST, she stated, "No, I am not familiar with that assessment". When asked if she had ever seen that tool, she stated, "No".

On 6/28/2022 at 12:41 PM, RN #2 was interviewed in relation to the required assessments. When asked if she conducted the SRST, she stated she had not heard of that tool.

On 6/28/2022 at 12:49 PM, RN #3 was interviewed in relation to the required assessments. When asked if she conducted the SRST, she stated that she had not heard of that assessment...that it was not part of the electronic medical record.

On 6/29/2022 at 2:38 PM, an interview was conducted with the Board of Directors Chairman and the Board of Directors Chairman of Compliance. When the Board of Directors Chairman was asked if the board was aware of assessments for psychiatric patients not being done, she stated, "I am not aware of those items not being done or any concerns in that area...I am not recalling anything on that".

2. The hospital's policy titled, "Psychiatric and Violent Patients", last reviewed 1/2022, indicates, in part, the following: "Upon arrival to the Emergency Department, the patient will be placed in a hospital gown, or color-coded paper scrubs depending on the Colombia severity score given during triage. If a patient is scored as high-risk, they will be placed in maroon paper scrubs, medium risk in teal and low risk in a regular hospital gown".

This policy was not implemented as evidenced by the following:

Surveyors reviewed Patient #8's medical record. The documentation in the record stated the following:
- On 6/14/2022 at 11:34 AM, the patient entered the ED with a chief complaint of being anxious, depressed, and suicidal, with self-injurious actions within the previous forty-eight (48) hours; and
- On 6/14/2022 at 12:16 PM, RN #4 completed the C-SSRS with a score of "high risk" for this patient.

As of 6/30/2022 at 2:00 PM, there were no paper scrubs available for patient use at the hospital.

Surveyors reviewed Patient #5's medical record. The documentation in the record stated the following:
- On 6/28/2022 at 8:34 AM, the patient entered the ED with a chief complaint of Depression, Suicidal Thoughts and Delusions; and
- At 9:55 AM, RN #1 completed the C-SSRS with a score of "high risk" for this patient.

As of 6/30/2022 at 2:00 PM, there were no paper scrubs available for patient use at the hospital.

Surveyors reviewed Patient #31's medical record. The documentation in the record stated the following:
- On 6/28/2022 at 9:34 AM, the patient entered the ED with a chief complaint of depression, suicidal thoughts, and anxiety; and
- On 6/28/2022 at approximately 10:26 AM, RN #3 completed the C-SSRS with a score of "high risk" for this patient.

As of 6/30/2022 at 2:00 PM, there were no paper scrubs available for patient use at the hospital.

On 6/27/2022 at 11:33 AM, surveyors were asked to meet with the Chief Nursing Officer, the Quality Improvement Nurse and Emergency Department Director in relation to a recent sentinel event that prompted a Root Cause Analysis ("RCA") meeting.
- The Quality Improvement Nurse stated, in part, "An outcome of the RCA [conducted on 6/9/2022] was that we had trouble obtaining scrubs...for the RCA, we invite the people involved who were in the case...we use the standard framework and identify the cause. We were reviewing the process and learned we are unable to get scrubs...the two items from the RCA were to review policy and get paper scrubs. The RCA is not done, it is not due to the Sentinel team until 7/15/2022...we put a due date to 7/31/2022 to complete items".
- The Chief Nursing Officer stated, in part, "The ED does not carry paper scrubs...".

On 6/27/2022 at 12:30 PM, surveyors interviewed the Materials Manager for the hospital in relation to the availability of paper scrubs.
- She stated that she had no paper scrubs in the facility and had not been asked about them since the winter of 2021;
- She stated no one, in her recent memory had asked her to purchase paper scrubs; and
- She looked up the availability of paper scrubs with one (1) of her suppliers with surveyors present and she verified that paper scrubs are available to order.

On 6/27/2022 at 1:22 PM, RN #1 was interviewed. She was asked if she recalls having paper scrubs for "high risk" patients and she said, "We have never had paper scrubs".

Based on interviews and document reviews, the hospital failed to ensure that all medical records were accurately documented for one (1) of forty-six (46) Emergency Department ("ED") patient records ( Patient #11).

Findings:

The Down East Community Hospital "Medical Record Completion Policy" last reviewed 10/2018, states, in part, "The documentation in the medical record will be detailed, complete and accurate..."

Documentation of Patient #11's ED visit by Nurse #5, on 6/21/2022 stated, in part, "The patient left the ED before triage. The patient appears to be alert, oriented X 4, coherent and in no acute distress. The patient did not notify staff prior to leaving the department. The patient left the ED ambulatory and via private vehicle."

On 6/27/2022 at 11:13 AM, an interview with ED Staff Nurse #5 was conducted. She was asked if she had seen the patient during their visit, she stated, "I did not see the patient, they left before triage". She was then asked how she was able to ascertain that the patient appeared to be alert, oriented X 4, coherent and in no acute distress. She stated, "I put appears alert and oriented because they were able to register".

Based on document reviews and interviews, the hospital failed to implement, and maintain an effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement ("QAPI") program that demonstrated the effectiveness of the program related to the Emergency Department ("ED") chosen indicators.

Findings:

The Quality Assessment and Performance Improvement Program has failed to maintain an effective and data-driven program related to the ED as evidenced by the following:

Condition: §485.641 CoP: Quality Assessment and Quality Improvement, also known as (C- 1300) - Based on document reviews and interviews, it was determined that the Condition of Participation for Quality Improvement and Performance Improvement was not met as evidenced by the hospital's failure to demonstrate evidence of the effectiveness of the program related to the Emergency Department indicators. See C-1306, C-1313, C-1319 and C-1325 for details.

Standard: §485.641(b)(2), (b)(3) - The hospital's QAPI program must be ongoing and comprehensive, involve all departments of the hospital and services including those services furnished under contract or arrangement. also known as C-1306 - Based on document review and interviews, the hospital failed to ensure that the hospital's quality program known as Quality Improvement/Safety Program ("QIPS") was ongoing and comprehensive related to the ED quality indictors. See C-1306 for details.

Standard: §485.641(c) - The hospital's governing body or responsible individual is ultimately responsible for the hospital's QAPI program and is responsible and accountable for ensuring that the QAPI program meets the requirements of paragraph (b) of this section, also known as 1313 - Based on document reviews and interviews the hospital's governing body failed to be accountable and take full responsibility for the QAPI Program, related to the ED quality indicators. See C-1313 for details.

Standard: §485.641(d)(2) - The hospital must use the measures to analyze and track its performance, also known as 1319 - Based on document reviews and interviews, the hospital failed to use the Medical Staff and Nursing ED indicators to analyze and track their ED performance for three (3) of three (3) indicators. See C-1319 for details.

Standard: §485.641(e) - The hospital must use the measures to analyze and track its performance, also known as 1325 - Based on document reviews and interviews, the hospital failed to incorporate ED quality indicator data in order to achieve the goals of the QAPI program for three (3) of three (3) ED indicators. See C-1325 for details.

The cumulative effects of these deficient practices resulted in this CoP being out of compliance.

Based on document reviews and interviews, the hospital failed to ensure that the hospital quality program known as Quality Improvement/Patient Safety Program ("QIPS") was ongoing and comprehensive related to the Emergency Department ("ED") quality indictors.

Findings:

The Down East Community Hospital Quality Improvement/Patient Safety Program 2021 states, in part, "The QIPS Program includes the following assessments...2. Each hospital department and medical staff services will be required to identify at least one non-routine performance improvement indicator. Indicator results and improvements are reported to the QIPS monthly."

A review of the documentation of the Emergency Services Medical Staff quality indicator, stroke patients evaluated in the ED will meet all bundle elements, revealed no data from 12/2021 thru 5/2022.

On 6/29/202 at 11:37 AM, an interview was conducted with the Vice President of Quality. She was asked to explain the lack of data for the Medical Staff quality indicator related to stroke patients. She stated, "This gap was due to lack of an ED Service Chief and lack of involvement by ED Provider staff."

The facility had two (2) Nursing quality indicators:
1) That restraint documentation is present in nurses notes within six (6) months, lacked data from 6/2021 through 12/2021; and
2) To ensure that patients presenting with suicidal ideation are scored using the Columbia Scale during triage, lacked data from 4/2021 thru 12/2021.

On 6/29/202 at 11:37 AM, an interview was conducted with the Vice President of Quality. When asked why the lack of data for the Nursing quality indicators, the Vice President of Quality stated, "The ED was missing a Director. The Chief Nursing Officer at that time just didn't work out."

A review of the QIPS meeting minutes from 12/2021 thru 5/2022 revealed no discussion of the Medical Staff stroke quality indicator results and/or improvements. Additionally, the review of the QIPS meeting minutes from 4/2021 thru 12/2021 revealed no discussion of the two (2) Nursing quality indicator results and/or improvements.

A review of the ED Service Meeting Minutes dated 10/2021, 1/10/2022, 2/14/2022 and 3/14/22 revealed no discussion of the lack of recording quality data for the Medical Staff quality indicator.

Based on document reviews and interviews the hospital's Governing Body failed to be accountable and take full responsibility for the Quality Assessment and Performance Improvement ("QAPI") Program, related to the Emergency Department ("ED") quality indicators.

Findings:

The Down East Community Hospital Quality Improvement/Patient Safety Program states, in part, "...The Board of Trustees bears a legal and ethical obligation to all the citizens of the communities within the Down East Community Hospital area of service for the quality and safety of the patient services being provided. To fulfill that obligation, the Board of Trustees oversees a Quality Improvement/Safety program with the purpose of continually monitoring and improving the hospital's performance and it's patients' health outcomes in a cost effective manner. The Board delegates the responsibility for implementing the plan to the Medical Staff, QIPS committee and the Hospital's Leadership Team."

The Quality Indicators review report dated January 2022 documented three (3) ED quality indicators. The ED Nursing indicators were:
1) That restraint documentation is present in nurses notes within six (6) months (initiated May 2021) and this indicator lacked data from 6/2021 through 12/2021; and
2) To ensure that patients presenting with suicidal ideation are scored using the Columbia Scale during triage (initiated April 2020 and this indicator lacked data from 4/2021 thru 12/2021.

The Board of Trustees Meeting Minutes from 6/2021 through 5/2022 were reviewed. There was no documented evidence of a discussion about the lack of data related to the three (3) ED quality indicators.

The ED Medical Staff quality indicator was that stroke patients evaluated in the ED will meet all bundle elements (initiated May 2019) and this indicator lacked data from 12/2021 thru 5/2022.

On 6/29/202 at 11:37 AM, an interview was conducted with the Vice President of Quality. She was asked to explain the lack of data for the Medical Staff quality indicator related to stroke patients. She stated, "This gap was due to lack of an ED Service Chief and lack of involvement by ED Provider staff." When asked why the lack of data for the Nursing quality indicators, the Vice President of Quality stated, "The ED was missing a Director. The Chief Nursing Officer at that time just didn't work out."

On 6/29/2022 at 2:38 PM, an interview was conducted with the Board of Directors Chairman and the Board of Directors Chairman of Compliance. When the Board of Directors Chairman was asked if the board was aware of assessments for psychiatric patients not being done, she stated, "I am not aware of those items not being done or any concerns in that area...I am not recalling anything on that".

Based on document reviews and interviews, the hospital failed to use the Medical Staff and Nursing Emergency Department ("ED") indicators to analyze and track their ED performance for three (3) of three (3) indicators.

Findings:

The Quality Indicators review report dated January 2022 documented three (3) ED quality indictors. The ED indicators were:
1) That restraint documentation is present in nurses notes within six (6) months (initiated May 2021) and this indicator lacked data from 6/2021 through 12/2021;
2) To ensure that patients presenting with suicidal ideation are scored using the Columbia Scale during triage (initiated April 2020) and this indicator lacked data from 4/2021 thru 12/2021; and
3) The Medical Staff quality indicator chosen for review was that stroke patients evaluated in the ED will meet all bundle elements (initiated May 2019) and this indicator lacked data from 12/2021 thru 5/2022.

On 6/29/2022 at 11:37 AM, an interview was conducted with the Vice President of Quality. She stated that the absence of data was due to not having an ED Medical Director, ED Director, and lack of involvement of other ED providers.

Based on document reviews and interviews, the hospital failed to incorporate Emergency Department ("ED") quality indicator data in order to achieve the goals of the Quality Assessment Performance Improvement ("QAPI") program for three (3) of three (3) Emergency Department ("ED") indicators.

Findings:

The Quality Indicators review report dated January 2022 documented three (3) ED quality indictors. They are as follows:
1) The Nursing Staff quality indicator was that restraint documentation is present in nurses notes within six (6) months (initiated May 2021) and this indicator lacked data from 6/2021 through 12/2021;
2) The second Nursing Staff quality indicator was to ensure that patients presenting with suicidal ideation are scored using the Columbia Scale during triage (initiated April 2020) and this indicator lacked data from 4/2021 thru 12/2021; and
3) The Medical Staff quality indicator was that stroke patients evaluated in the ED will meet all bundle elements (initiated May 2019) and this indicator lacked data from 12/2021 thru 5/2022.

On 6/29/2022 at 11:37 AM, an interview was conducted with the Vice President of Quality. She stated that the absence of data was due to not having an ED Medical Director, ED Director, and lack of involvement of other ED providers.