HospitalInspections.org

Based on document reviews and interviews, the hospital failed to meet the Condition of Participation for Organizational Structure as evidenced by the following:

The hospital's governing body failed to provide oversight over the hospital's Quality Assurance and Performance Improvement ("QAPI") program resulting in hospital-wide noncompliance with the hospital's quality improvement plan (C-0962).

The hospital's governing body failed to provide oversight over the hospital's policy creation and review process (C-0962).

The hospital's governing body failed to ensure senior members of the hospital leadership including the hospital's Chief Nursing Officer ("CNO") were educated on the hospital's Policy Management Policy (C-0962).

The cumulative and ongoing effects of these deficient practices have led to noncompliance with this Condition of Participation.

Please see C-0962 for details.

Based on document review, interviews, and observation, the hospital failed to perform morning ("AM") and night ("PM") equipment checks in one (1) out of (1) Emergency Departments observed.

Findings:

Interviews with Vice President of Corporate Compliance/Risk Management/Quality and the Infection Preventionist, confirm there is no policy outlining the requirements to ensure performing equipment checks in the Emergency Department.

During administrative document review, May 2025 Emergency Department Daily Check Log, which requires AM/PM checks, showed incomplete documentation of the following equipment checks.

- Warmer, missing seven (7) of twelve (12) AM checks and eight (8) out of twelve (12) PM checks.
- Blanket Warmer, missing seven (7) of twelve (12) AM checks and eight (8) out of twelve (12) PM checks.
- Glidescope, missing six (6) of twelve (12) AM checks and seven (7) out of twelve (12) PM checks.
- Intubation Boxes, missing seven (7) of twelve (12) AM checks and seven (7) out of twelve (12) PM checks.
- Metal Bin #1, missing twelve (12) of twelve (12) AM checks and three (3) out of twelve (12) PM checks.
- Metal Bin #2, missing twelve (12) of twelve (12) AM checks and three (3) out of twelve (12) PM checks.
- Oxygen Tree x 2, missing seven (7) of twelve (12) AM checks and nine (9) out of twelve (12) PM checks.
- Suction Set Up x 2, missing twelve (12) of twelve (12) AM checks and three (3) out of twelve (12) PM checks.
- Two (2) out of three (3) normal saline solutions (NSS) were found without an expiration date in the warmer.

Incomplete documentation was verified on 05/12/2025 at 11:45 AM by RN #3, on 05/14/2025 at 11:00 AM by the Vice President of Corporate Compliance/Risk Management/Quality, on 05/15/2025 at 10:25 AM by RN #4, and at 10:40 AM by RN #5.

Based on interviews, and observation, the hospital failed to ensure two (2) out of three (3) intravenous ("IV") fluids observed in the warmer in the Emergency Department were labeled with the expiration date and time.

Findings:

Interviews with Vice President of Corporate Compliance/Risk Management/Quality and the Infection Preventionist confirmed there was no policy outlining the requirements to ensure proper dating/labeling IV fluids that are placed in the warmer for patients use.

On 05/12/2025 at 11:45 AM, the surveyor observed during observations of the Emergency Department that two (2) out of three (3) normal saline solutions in the IV fluid warmer were found without an expiration date and time. RN #3 was present during the observation and confirmed these findings.

Based on interviews, and observation, the hospital failed to ensure that three (3) out of three (3) observed intravenous line ("IV") carts that contained needles and syringes and which were located in a publicly accessible area in the Emergency Department, were locked. (Cardiac room, hallway, and trauma room)

Finding:

On 05/12/2025 at 11:50 AM the surveyor observed IV carts located in the cardiac room, hallway, and trauma room of the Emergency Department were left unlocked. This was confirmed by RN #3 and the Chief Nursing Officer who were present at the time of observation.

Based on observations and interviews, the hospital failed to maintain a clean and uncluttered physical environment. Cracked floor tiles, stained ceiling tiles, and cluttered hallways were identified during the survey.

Findings:

The following floor tiles were observed in disrepair:

- On 5/12/2025 on a tour of the hospital, cracked floor tiles were noted in the utility rooms on the Medical-Surgery unit at 2:26 PM and 2:48 PM. This created surfaces which could not be easily cleaned and sanitized. The Maintenance Engineer confirmed these findings at the time of observation.

- On 5/13/2025 on a tour of the hospital, cracked floor tiles were noted on the ground floor hallway by the cafeteria at 12:15 PM. This created surfaces which could not be easily cleaned and sanitized. The Maintenance Engineer confirmed these findings on 5/15/2025 at 10:35 AM.

- On 5/15/2025 on a tour of the hospital, cracked floor tiles were noted in the ground floor hallway by the elevator at 8:33 AM. This created a surface which could not be easily cleaned and sanitized. The Maintenance Engineer confirmed these findings on 5/15/2025 at 10:33 AM.

The following ceiling tiles were observed in disrepair:

-On 5/12/2025 on a tour of the hospital, stained ceiling tiles were noted in the Pharmacy at 1:42 PM.

-On 5/12/2025 on a tour of the hospital, stained ceiling tiles were noted in the Soiled Utility Room and Electrical Utility Room on the 2nd floor at 2:27 PM and 2:34 PM. This was confirmed with the Maintenance Engineer at the time of observation.

-On 5/13/2025 on a tour of the hospital, stained and missing ceiling tiles were noted in the Emergency Department at 10:18 AM. This was confirmed with the Vice President of Corporate Compliance/Risk Management/Quality at the time of observation.

-On 5/13/2025 on a tour of the offsite Physical Therapy practice, stained ceiling tiles were noted at this location at 2:24 PM and 2:29 PM. This was confirmed with the Physical Therapy Coordinator at the time of observation.

Clutter in hallways was observed:

-On a tour of the hospital on 5/12/2025, stored equipment was noted in the hallway by the exit on the Medical-Surgical unit at 2:07 PM.

-On a tour of the hospital on 5/13/2025, stored equipment was noted in the hallway by the back exit on the ground floor at 12:16 PM.

The Maintenance Engineer confirmed these findings at the time of observation.

Based on document reviews and interviews the hospital failed to maintain the temperature and humidity in the procedure rooms and the Central Sterile Room ("CSR"), according to the 2025 Association of perioperative Registered Nurses ("AORN") standards, the standards the hospital adopted.

Findings:

The 2022 Association of perioperative Registered Nurses ("AORN") Edition page 97 contains standards related to temperature and humidity in the following areas: Procedure Rooms 30% to 60% humidity; Sterile Processing Clean Assembly Workroom maximum 60% humidity and temperature 68 to 73 degrees Fahrenheit.

The Millinocket Regional Hospital policy titled, "Environment Humidity, Air Temperature in Surgical Areas, last reviewed 08/02/2022, stated in part, "Room temperature and humidity will be recorded by the following:
a. By operating room personnel on the Intra-Operative Record
b. A log will be maintained in the OR Registry Log Book".

On 05/14/2025, at 9:45 AM, an interview was conducted with Operating Room ("OR") Director, regarding the documentation of the Operating Room Temperatures and Humidity. She was asked if she completed the documentation of the temperature and humidity logs in the OR Registry Log Book. She stated there were no OR Registry Log Books with a record of operating room temperatures and humidity.

Based on document reviews and interviews, the hospital's governing body failed to provide oversight over the hospital's Quality Assurance and Performance Improvement ("QAPI") program resulting in hospital-wide noncompliance with the hospital's quality improvement plan.

Findings:

Millinocket Regional Hospital's Quality Improvement Plan for 2024 states in part:

"...Professional Affairs Committee: The Professional Affairs Committee (PAC) is a multidisciplinary group that is designated by the Board of Trustees to provide oversight and direction for the quality and performance improvement program... The PAC shall consist of at least two Board Trustees, one physician, one to two allied health professionals, Senior Leadership to include the CEO, CNO, CQO, and CFO. PAC meetings will be scheduled on a quarterly basis. Activities include but are not limited to:

1.Assisting the Governing Board and the MSEC with the development and evaluation of the Quality Improvement Plan ...Receive and review the reports regarding the effectiveness of MRH's hospital wide QAPI (Quality Assurance Performance Improvement) activities...Act upon data reviewed...Reporting to the Board of Trustees...

Governing Board:
The Board of Trustees shall be responsible to ensure optimal quality care, safety, and organization-wide performance are provided. The Board is ultimately responsible for the safety and quality of patient care provided in every department and service of the hospital. The Board has legal responsibility and authority of hospital performance. The Board delegates operational responsibility to the Medical Staff and Administration. The Board shall facilitate the Quality Program by:

1.Authorizing the Professional Affairs Committee to implement the QAPl (Quality Assurance Performance Improvement) Program...Establish an organization wide structure that supports a commitment to quality and patient safety...Ensure the quality program reflects the hospital's organization and services...Receives reports of QAPI data from all departments and services of the hospital, including contracted services...

Hospital Departments:

The Department Leaders are accountable for the quality and safety of care/services and performance of their staff and departments. Department Directors and Managers are responsible for the systematic monitoring and analysis of the quality and safety of care provided in their departments. Directors will:

1.Prioritize and communicate opportunities for improvement relating to their department.
2.Monitor, analyze and report the processes in their areas that affect patient care, safety, outcomes and satisfaction...Participate in the quality improvement team and report QAPI data evaluated and actions taken as appropriate...

Data Collection: The department staff will collect, organize and analyze data performance benchmarks. Data will be organized to facilitate comparison and trends. Tools include but are not limited to control charts, graphs, and run charts. The data collected will be collected and reported in a timely and efficient manner. Frequency of Data Collection: Data will be collected by designated department staff on a quarterly basis. The frequency of data collection may require more detail and frequency based upon priority issues and adverse or significant events..."

During an in-person interview on 05/13/2025 at 1:05 PM, the Vice President of Corporate Compliance/Risk Management/Quality indicated that the hospital's QAPI committee was called the Corporate Compliance and Professional Affairs Committee ("PAC"). She stated the PAC was the only quality (QAPI) committee at the hospital. She stated they did not have discussions about specific quality data at the [PAC], and she stated that the quality committee (PAC) was "not a very active committee."

On 05/13/2025 at 1:20 PM, the Vice President of Corporate Compliance/Risk Management/Quality indicated that unless there was a concern or issue, the Quality Department would not discuss quarterly quality information with the board/governing body. She additionally confirmed that the governing body were not aware of all of the other functions of the QAPI (PAC) committee.

A review of Millinocket Regional Hospital's Professional Affairs Committee meeting minutes for 2024 revealed that the Professional Affairs Committee only met two (2) times in 2024 (03/01/2024 & 12/09/2024) and that no physician was present for either of the two (2) Professional Affairs Committee meetings.

Board of Trustees meeting minutes were reviewed for 12/09/2024, 01/27/2025, 02/24/2025, 06/24/2024, 07/29/2024, 09/16/2024, 10/28/2024, 03/31/2025 and the meeting minutes did not reveal evidence of the discussion of any specific QAPI data. The meeting minutes revealed a section titled, "Professional Affairs/Corporate Compliance Committee," and each of the reviewed meeting minutes revealed either of the following statement, "...No pressing issues to bring to the Board...," or "...The committee did not meet since the last Board meeting..." One (1) of the meeting minutes did not mention the Professional Affairs/Corporate Compliance Committee at all.

The Vice President of Corporate Compliance/Risk Management/Quality confirmed on 05/14/2025 at 11:12 AM that the department directors were supposed to be reporting quality data to her but were failing to do so, she confirmed that the governing body was not discussing QAPI at board meetings.

During a telephone interview with Board Member #1 on 05/14/2025 at 1:33 PM, when Board Member #1 was questioned regarding why the governing body/board meeting minutes from the past two (2) (02/24/2025 & 03/31/2025) board meetings did not show any information from quality, he stated the board, "must not have talked about any of it." When Board Member #1 was questioned regarding why the PAC committee meeting minutes for 2024 did not show evidence that there was any discussion of quality measures during the PAC meetings, he stated it sounded to him like they (the PAC), "hadn't done a quality discussion at those meetings." He confirmed that that it was his responsibility to review the quality information from the Professional Affairs Committee and take it to the board at the board meeting.

During an in-person interview on 05/15/2025 at 10:24 AM. The Vice President of Corporate Compliance/Risk Management/Quality stated the managers were not providing quality information to her. She stated she had asked for quality data and stated some of the managers were good about doing it and some "just don't know what to do." She stated she had offered to help the department managers to develop quality measures, but "they [the department managers] are just not doing it." She stated she had escalated her concerns about this to the Chief Executive Officer, ("CEO"). She stated the plan was that if the managers didn't report their quality data, [the department managers] would have to come in person to the Professional Affairs Committee meeting to explain why, "but that did not happen."

During the in-person interview on 05/15/2025 at 10:24 AM, the Vice President of Corporate Compliance/Risk Management/Quality confirmed that she attended all of the Professional Affairs Committee meetings, and stated she ran the meetings. She stated that less than half of the hospital's quality data was presented to board members during the PAC meetings. She stated it was the board members' responsibility to bring the quality data from the PAC meetings to the governing body at the board meetings. She stated the board members didn't get any of the quality data at the board/governing body meetings, and stated [the board members] just get the "30,000 feet" if there was any concern. She stated QAPI data didn't flow up to the board at all unless there was a concern. She stated only the governing body members that sit on the PAC committee had input on QAPI measures, and she indicated this only included two (2) board members - Board Member #1, and the Board President.

A document titled, "Quality Summary," was provided to the survey team on 05/15/2025 by the hospital's Vice President of Corporate Compliance/Risk Management/Quality. A review of the document revealed the following information:
-No Quality information was reported for Med-Surg for Quarter #3 2023, Quarter #1 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Lab for Quarter #3 2024, Quarter #4 2024
-No Quality information was reported for Housekeeping for Quarter #1 2025
-No Quality information was reported for the Emergency Room ("ER") also known as the Emergency Department ("ED") for Quarter #1 2024, Quarter #2 2024
-No Quality information was reported for Rehab for Quarter #3 2024,
-No Quality information was reported for Dietary for Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Operating Room for Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-Quality information was blank for the Pharmacy or Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, & Quarter #4 2024
-No Quality information was reported for Cardiopulmonary for Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
On 05/15/2025 at 10:24 AM the Vice President of Corporate Compliance/Risk Management/Quality reviewed the above information with the survey team and confirmed the information was correct and that no quality data was reported by these departments during these quarters.

On 05/15/2025 at 11:03 AM the Board President (President of the Board of Trustees also known as the hospital's governing body) confirmed during an in-person interview that she was the president of the board and a member of the PAC. She indicated that she was responsible for bringing the information from the PAC to the board meetings. She stated the information about quality that they got at the PAC meetings were information about the quality plan, who had reported their quality data and who hadn't, as well as what the plan was to receive the data that hadn't been reported. She stated she did not recall seeing a lot of the actual quality reports themselves. She stated it was typically only if there was an issue. She stated quality wasn't reviewed at every PAC meeting, and she stated specific quality measures were not shared with the board each quarter. She stated she did not recall the specific quality measures being shared at the board meetings in a "long time," and over the past 10 years the board had left, "all of the operation things to the administration team." She stated the board got a "30,000 foot view of everything quality," to try to steer the direction without, "being in the middle of day to day stuff." She added that the board designated the CEO as the person responsible for all of the, "operational stuff." She stated the board, "has been so heavily focused on finance we have run out of time to do everything else," and she stated that as the president of the board, she did not know that many departments had not reported quality data for most of [2024].

On 05/15/2025 at 11:13 AM the Board President reviewed the document titled, "Quality Summary" with the surveyor which included a review of the following data:
-No Quality information was reported for Med-Surg for Quarter #3 2023, Quarter #1 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Lab for Quarter #3 2024, Quarter #4 2024
-No Quality information was reported for Housekeeping for Quarter #1 2025
-No Quality information was reported for the Emergency Room ("ER") also known as the Emergency Department ("ED") for Quarter #1 2024, Quarter #2 2024
-No Quality information was reported for Rehab for Quarter #3 2024,
-No Quality information was reported for Dietary for Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Operating Room for Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-Quality information was blank for the Pharmacy or Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, & Quarter #4 2024
-No Quality information was reported for Cardiopulmonary for Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
Following the review, the Board President stated she was not aware that quality data was not reported by these departments in the above quarters. The Board President stated the board was not aware of the missing quality data either.

Based on document reviews and interviews, the hospital's governing body failed to provide oversight over the hospital's policy creation and review process.

Findings:

Millinocket Regional Hospital's policy titled, "MRH Policy Management," (not dated) states in part:

"...1. Policies in all areas and departments of the hospital will be developed, approved and revised with consideration of input from key stakeholders of the related content.

2. For policies and procedures involving 'patient care' services, the process of development, approval, revision and review will include consideration of the advice of a group or committee whose membership includes at least one doctor of medicine or osteopathy and one or more physician assistants, nurse practitioners and clinical nurse specialist on staff.

3.All policies are required to be reviewed biennially by such group or committee and whenever necessary to assure compliance with accepted practice, regulations and standards..."

The Vice President of Corporate Compliance/Risk Management/Quality confirmed via an email ("Email #1") sent to the survey team on 05/13/2025 at 7:28 PM that the hospital's policies were required to be reviewed every two (2) years.

On 05/14/2025 at 12:37 PM, the survey team sent an email request ("Email #2") for a master list of all policies showing the last date each of those policies was reviewed.

On 05/14/2025, the hospital provided a document to the survey team titled, "MRH Active Policy Documents with All Revision Dates," which the Vice President of Corporate Compliance/Risk Management/Quality indicated was a list of all of the hospitals policies, including the date the policies were last reviewed. A review of the document revealed that one-hundred-thirty-two (132) out of the two-hundred-fifteen (215), or approximately sixty-one percent (61%) of the hospital's policies, had not been reviewed in over two (2) years with last reviewed dates going as far back as the year two-thousand-nineteen (2019).


Based on document reviews and interviews the hospital's governing body failed to ensure senior members of the hospital leadership including the hospital's Chief Nursing Officer ("CNO") were educated on the hospital's Policy Management Policy.

Findings:

Millinocket Regional Hospital's policy titled, "MRH Policy Management," (not dated) states in part:

"...1. Policies in all areas and departments of the hospital will be developed, approved and revised with consideration of input from key stakeholders of the related content.

2.For policies and procedures involving 'patient care' services, the process of development, approval, revision and review will include consideration of the advice of a group or committee whose membership includes at least one doctor of medicine or osteopathy and one or more physician assistants, nurse practitioners and clinical nurse specialist on staff..."

On 05/15/2025 at 8:53 AM the survey team received an email ("Email #3") which stated in part, "...Good Morning, While searching for these policies to deliver as requested, it is apparent that when our policies were compromised last summer, those policies were not recovered. As the new CNO, to close that gap, I have created new policies that staff will be educated on, and they will be uploaded to our policy library. Please see new attached policies ..." The email included attached policies titled, "Medication Ordered STAT and at Specified Time Intervals, Adverse Drug Reaction Definition and Process, & Telephone and Verbal Order Policy."

During an in-person interview on 05/15/2025 at 9:23 AM, the CNO stated there, "was a gap so I rewrote some policies." The CNO stated she created the policies and stated she started working on the policies [on 05/14/2025]. The CNO stated she, "created the policies from scratch." When the CNO was questioned as whether or not she had to have policies and procedures approved by the governing body before instituting them, she stated she did not know the answer.

Based on document reviews and interviews, the hospital failed to ensure that one-hundred-thirty-two (132) out of two-hundred-fifteen (215) policies had been reviewed within two (2) years prior to the date of the initiation of the survey (05/12/2025).

Findings:

Millinocket Regional Hospital's policy titled, "MRH Policy Management," (not dated) states in part:

"...All policies are required to be reviewed biennially by such group or committee and whenever necessary to assure compliance with accepted practice, regulations and standards..."

The Vice President of Corporate Compliance/Risk Management/Quality confirmed via an email ("Email #1") sent to the survey team on 05/13/2025 at 7:28 PM that the hospital's policies were required to be reviewed every two (2) years.

On 05/14/2025 at 12:37 PM, the survey team sent an email request ("Email #2") for a master list of all policies showing the last date each of those policies was reviewed.

On 05/14/2025, the hospital provided a document to the survey team titled, "MRH Active Policy Documents with All Revision Dates," which the Vice President of Corporate Compliance/Risk Management/Quality indicated was a list of all of the hospitals policies, including the date the policies were last reviewed. A review of the document revealed that one-hundred-thirty-two (132) out of the two-hundred-fifteen (215), or approximately sixty-one percent (61%) of the hospital's policies, had not been reviewed in over two (2) years with last reviewed dates going as far back as the year two-thousand-nineteen (2019).

The document titled, "MRH Active Policy Documents with All Revision Dates," additionally revealed the following information related to specific service areas/departments:
-The hospital failed ensure sixty-seven percent (67%) of Central Sterile policies were reviewed
-The hospital failed to ensure fifty-seven percent (57%) of Nursing policies were reviewed
-The hospital failed to ensure seventy-two (72%) of Operating Room policies were reviewed
-The hospital failed to ensure one-hundred percent (100%) of Radiology policies were reviewed
-The hospital failed to ensure one-hundred percent (100%) of Rehabilitation policies were reviewed

Based on document reviews and interviews, the hospital failed to ensure that 1)policies and procedures were available to nursing staff for adverse drug reactions and 2)that leadership was able to identify an adverse drug reaction.

Findings:

In an American Society of Health-System Pharmacists ("ASHP") Adverse Drug Reaction Reporting article by Lee B. Murdaugh, RPh, PhD, he states in part, "The Conditions of Participation standards of the Centers for Medicare & Medicaid Services (CMS) and the standards of accrediting organizations such as The Joint Commission, the Healthcare Facilities Accreditation Program (HFAP), and the National Integrated Accreditation for Healthcare Organizations (NIAHOSM) require hospitals to identify and report adverse drug reactions (ADRs). These ADRs must be reported to patients' attending physicians and the hospital's quality assessment and performance improvement program."

On 05/12/2025, a request was made to the Vice President of Corporate Compliance/Risk Management/Quality for the adverse drug reaction and medication error policies and procedures.

On 05/15/2025 at 8:53 AM, after several requests for some nursing policies and procedures, the Chief Nursing Officer ("CNO") sent an email stating, "While searching for these policies to deliver as requested, it is apparent that when our policies were compromised last summer, those policies were not recovered. As the new CNO, to close that gap, I have created new policies that staff will be educated on, and they will be uploaded to our policy library. Please see new attached policies."

On 05/15/2025 at 9:23 AM, an interview was conducted with the CNO. She was asked about the new policies she created "last night" and the policy process. She stated the following:
- There was a compromise and they lost the policies and that was a gap;
- I re-wrote the policies, through internal policy and got with the supervisor and talked about the guidelines;
- I am able to put them in the [online] library and an all-staff meeting will go out today;
- For new policies, I review them with the [nursing] supervisors and I would review them with [the Vice President of Compliance]; and
- We had a previous policy but we were not able to find them.

On 05/15/2025 at 9:34 AM, an interview was conducted with the Chief Executive Officer ("CEO"). He was asked if he was aware that new policies and procedures were created and ready to be provided to staff today. He stated, "If she started a policy this week, I would not be aware of that."

On 05/15/2025 at 9:48 AM, an interview was conducted with the Information Technology Director and he was asked about a computer breech that occurred on 07/20/2024. He stated that they got a small amount of user files (Documents that people created on their own computers ). However, the policies and procedures are web based and not affected.

On 05/15/2025 at 11:01 AM, after several requests, the Vice President of Corporate Compliance/Risk Management/Quality sent an email stating, "We had no reported adverse drug reactions. Thank you." With this email, she attached a document titled, "Medication Error Report JAN 2024-PRESENT". This report contained information that there was, in fact, an adverse drug reaction on 02/04/2025. Further documentation was requested. The documentation provided shows the steps necessary for a complete review of this incident, which was not completed. Due to leadership not identifying this adverse drug reaction, it was not reported to the Quality Committee for review.

Based on document reviews and interviews, the hospital failed to ensure that nursing staff personnel files contained evidence of competency training to ensure that they could meet the needs of the patients for six (6) of twelve (12) nurses reviewed (Registered Nurse #3 - #8).

Findings:

On 05/15/2025 at 1:45 PM, the policies and procedures for new hires was requested however, the Director of Human Resources did not provide the information.

On 05/15/2025 at 10:05 AM, the Vice President of Corporate Complaince/Risk Management/Quality stated the hospital does not have an Emergency Department nurse manager. The Chief Nursing Officer stated the supervisors would have the nurse competency documents in their office, however, the Director of Human Resources was able to provide the information.

On 05/15/2025 at 1:50 PM, a review of twelve (12) nursing files were provided by the Director of Human Resources. The following was identified:
- Registered Nurse ("RN") #3's date of hire is 01/10/2022;
- RN #4's date of hire is 12/22/2021;
- RN #5's date of hire is 08/19/2024;
- RN #6's date of hire is 08/30/2024;
- RN #7's date of hire is 10/01/2024;
- RN #8's date of hire is 09/01/2024; and
- As of 05/15/2025, the required nursing competencies have not been completed.

Based on document review and interviews, the hospital failed to ensure Emergency Severity Index (ESI) was documented in one (1) out of ten (10) clinical records in the Emergency Department. (Patient #9)

Findings:

The hospital's policy titled, Emergency Department Triage, effective 03/22/2019, defines ESI as "A five level triage scoring system used to facilitate the prioritization of patients based on the urgency of patient condition." The policy states in part, "...All patients presenting to Millinocket Regional Hospital's Emergency Department will be evaluated by an appropriately trained registered nurse who will categorize each patient using the ESI levels of priority upon arrival to the Emergency Department 24 hours a day 7 days a week..."

During a clinical record review on 05/14/2025 at 9:30 AM, Patient #9's medical record was reviewed and revealed that no ESI was documented. The Vice President of Corporate Compliance/Risk Management/Quality and the Infection Preventionist, confirmed these findings.

Based on document review and interviews, the hospital failed to ensure that informed consent forms were obtained for one (1) out of ten (10) patient records reviewed (Patient #9).

Findings:

During a clinical record review on 05/14/2025 at 10:05 AM, patient #9's medical record was reviewed and revealed that no informed consent was obtained. The Vice President of Corporate Compliance/Risk Management/Quality and the Infection Preventionist, confirmed these findings during the clinical record review.

Based on observations and interviews, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infection.

Findings:

The following was found in disrepair:

- On 5/12/2025 on a tour of the hospital at 1:15 PM, tears in the upholstery of a sofa in the 2nd floor Family Room were noted. This created surfaces which could not be easily cleaned and sanitized.

- On 5/12/2025 on a tour of the hospital at 2:15 PM in Room 214 of the Special Care Unit, black tape loosely covering a vent in the ceiling and an exposed patch of the wall were observed. This created surfaces which could not be easily cleaned and sanitized.

These findings were confirmed by the Maintenance Engineer at the time of observation.

On 5/13/2025 on a tour of the lab area at 8:15 AM, an arm on a phlebotomy chair with a rip that was taped over with clear tape was observed. This created a surface which could not be easily cleaned and sanitized. This finding was confirmed by the Vice President of Corporate Compliance/Risk Management/Quality at the time of observation.

On 5/13/2025 on a tour of the offsite Surgery and Urology practice at 11:40 AM, a Urology examination table with rips in 2 corners was noted. This created a surface which could not be easily cleaned and sanitized. This finding was confirmed with the Practice Manager at the time of observation.

Based on document review and interview, the hospital failed to ensure that care plans were completed for one (1) out of ten (10) patient records reviewed (Patient #2).

Findings:

The hospital's policy titled "Swing Bed Comprehensive Care Plan," revised on 11/07/2024, states in part, "...A comprehensive care plan will be developed within 72 hours (3 business days) of completion of the comprehensive assessment..."

During a clinical record review on 05/14/2025 at 12:11 PM, Patient #2's medical record was reviewed and revealed that no care plan was completed. The Case/Utilization Review Manager confirmed these findings at this time.


Based on document review and interview, the hospital failed to ensure Resident Assessment Instruments ("RAI") were completed for two (2) out of ten (10) patient records reviewed (Patient #1 and Patient #2).

Findings:

The hospital's policy titled, "Swing Bed Comprehensive Assessment," effective 07/15/2020, states in part, "...a comprehensive assessment of a resident's needs, strength, goals, life history and preferences no later than 5 days after admission or within 72 hours after any significant change in patient's physical or mental condition..."

During a clinical record review on 05/14/2025 at 12:09 PM, Patient #1's medical record was reviewed and revealed that no RAI was completed. The Case/Utilization Review Manager confirmed these findings at this time.

During a clinical record review on 05/14/2025 at 12:12 PM, Patient #2's medical record was reviewed and revealed that no RAI was completed. The Case/Utilization Review Manager confirmed these findings at this time.

Based on document review and interviews, the facility failed to ensure the State law requiring a criminal history record is obtained for individuals who will work in direct contact with a consumer in two (2) of ten (10) personnel files reviewed (Registered Nurse ("RN") #1 & RN #2.)

Findings:

The Maine Revised Statutes Annotated, Title 22, Subtitle 2, Part 4, Chapter 401, subsection 1724 states; "Beginning October 1, 2010, a facility or health care provider subject to the licensing or certification processes of chapter 405...shall obtain, prior to hiring an individual who will work in direct contact with a consumer, criminal history record information on that individual, including, at a minimum, criminal history record information from the Department of Public Safety, State Bureau of Identification."

A randomly selected sample of ten (10) personnel files was reviewed to determine compliance with State regulations. Of these records, two (2) of ten (10) employees (RN #1 & RN #2), who were hired on or after October 1, 2010, failed to have evidence of a criminal background check containing a minimum, criminal history record information from the Department of Public Safety, State Bureau of Identification.

On May 15, 2025, at approximately 11:45 AM, the Director of Human Resources confirmed RN #1 & RN #2's personnel records did not have the required criminal background checks.

Based on document reviews and interviews, the hospital failed to meet the Condition of Participation for Quality Assessment and Performance Improvement ("QAPI") Program as evidenced by the following:

The hospital failed to ensure the Medical/Surgical ("Med-Surg") Unit, Laboratory, Housekeeping, Emergency Room ("ER") also known as the Emergency Department ("ED"), Rehabilitation, Dietary, Operating Room ("OR"), Pharmacy, & Cardiopulmonary departments were consistently collecting and reporting QAPI data to the hospital's Quality Department (C-1302).

The hospital failed to ensure the governing body, also known as "The Board of Trustees," was aware of the activities of the hospital's QAPI program including the failure of the hospital's QAPI program to ensure consistent participation of all of the hospital's departments (C-1313).

The cumulative and ongoing effects of these deficient practices have led to noncompliance with this Condition of Participation.

Please see C-1302 & C-1313 for details.

Based on document reviews and interviews, the hospital failed to ensure the Med-Surg Unit, Laboratory, Housekeeping, ER, Dietary, Operating Room, Pharmacy and Cardiopulmonary departments were consistently collecting and reporting QAPI data to the hospital's Quality Department.

Findings:

Millinocket Regional Hospital's Quality Improvement Plan for 2024 states in part, "...Data Collection: The department staff will collect, organize and analyze data performance benchmarks. Data will be organized to facilitate comparison and trends. Tools include but are not limited to control charts, graphs, and run charts. The data collected will be collected and reported in a timely and efficient manner. Frequency of Data Collection: Data will be collected by designated department staff on a quarterly basis. The frequency of data collection may require more detail and frequency based upon priority issues and adverse or significant events..."

On 05/14/2025 at 11:11 AM, the Vice President of Corporate Compliance/Risk Management/Quality confirmed that the department directors were supposed to be reporting quality data to her, but were failing to do so.

During an in-person interview on 05/15/2025 at 10:24 AM. The Vice President of Corporate Compliance/Risk Management/Quality stated the managers were not providing quality information to her. She stated she had asked for quality data and stated some of the managers were good about doing it and some "just don't know what to do." She stated she had offered to help the department managers to develop quality measures, but "they [the department managers] are just not doing it." She stated she had escalated her concerns about this to the Chief Executive Officer, ("CEO"). She stated the plan was that if the managers didn't report their quality data, [the department managers] would have to come in person to the Professional Affairs Committee meeting to explain why, "but that did not happen."

A document titled, "Quality Summary," was provided to the survey team on 05/15/2025 by the hospital's Vice President of Corporate Compliance/Risk Management/Quality. A review of the document revealed the following information:
-No Quality information was reported for Med-Surg for Quarter #3 2023, Quarter #1 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Lab for Quarter #3 2024, Quarter #4 2024
-No Quality information was reported for Housekeeping for Quarter #1 2025
-No Quality information was reported for the Emergency Room ("ER") also known as the Emergency Department ("ED") for Quarter #1 2024, Quarter #2 2024
-No Quality information was reported for Rehab for Quarter #3 2024,
-No Quality information was reported for Dietary for Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Operating Room for Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-Quality information was blank for the Pharmacy or Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, & Quarter #4 2024
-No Quality information was reported for Cardiopulmonary for Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
On 05/15/2025 at 10:24 AM the Vice President of Corporate Compliance/Risk Management/Quality reviewed the above information with the survey team and confirmed the information was correct and that no quality data was reported by these departments during these quarters.

Based on document reviews and interviews, the hospital failed to ensure the Med-Surg Unit, Laboratory, Housekeeping, ER, Dietary, Operating Room, Pharmacy and Cardiopulmonary departments were consistently collecting and reporting QAPI data to the hospital's Quality Department.

Findings:

Please see C-1302 for details.

Based on document reviews and interviews, the hospital failed to ensure the governing body, also known as "The Board of Trustees," was aware of the activities of the hospital's QAPI program including the failure of the hospital's QAPI program to ensure consistent participation of all of the hospital's departments

Findings:

Millinocket Regional Hospital's Quality Improvement Plan for 2024 states in part:

"...Professional Affairs Committee: The Professional Affairs Committee (PAC) is a multidisciplinary group that is designated by the Board of Trustees to provide oversight and direction for the quality and performance improvement program... The PAC shall consist of at least two Board Trustees, one physician, one to two allied health professionals, Senior Leadership to include the CEO, CNO, CQO, and CFO. PAC meetings will be scheduled on a quarterly basis. Activities include but are not limited to:

1.Assisting the Governing Board and the MSEC with the development and evaluation of the Quality Improvement Plan ...Receive and review the reports regarding the effectiveness of MRH's hospital wide QAPI (Quality Assurance Performance Improvement) activities...Act upon data reviewed...Reporting to the Board of Trustees...

Governing Board:
The Board of Trustees shall be responsible to ensure optimal quality care, safety, and organization-wide performance are provided. The Board is ultimately responsible for the safety and quality of patient care provided in every department and service of the hospital. The Board has legal responsibility and authority of hospital performance. The Board delegates operational responsibility to the Medical Staff and Administration. The Board shall facilitate the Quality Program by:

1.Authorizing the Professional Affairs Committee to implement the QAPl (Quality Assurance Performance Improvement) Program...Establish an organization wide structure that supports a commitment to quality and patient safety...Ensure the quality program reflects the hospital's organization and services...Receives reports of QAPI data from all departments and services of the hospital, including contracted services...

Hospital Departments:

The Department Leaders are accountable for the quality and safety of care/services and performance of their staff and departments. Department Directors and Managers are responsible for the systematic monitoring and analysis of the quality and safety of care provided in their departments. Directors will:

1.Prioritize and communicate opportunities for improvement relating to their department.
2.Monitor, analyze and report the processes in their areas that affect patient care, safety, outcomes and satisfaction...Participate in the quality improvement team and report QAPI data evaluated and actions taken as appropriate...

Data Collection: The department staff will collect, organize and analyze data performance benchmarks. Data will be organized to facilitate comparison and trends. Tools include but are not limited to control charts, graphs, and run charts. The data collected will be collected and reported in a timely and efficient manner. Frequency of Data Collection: Data will be collected by designated department staff on a quarterly basis. The frequency of data collection may require more detail and frequency based upon priority issues and adverse or significant events..."

During an in-person interview on 05/13/2025 at 1:05 PM, the Vice President of Corporate Compliance/Risk Management/Quality indicated that the hospital's QAPI committee was called the Corporate Compliance and Professional Affairs Committee ("PAC"). She stated the PAC was the only quality (QAPI) committee at the hospital. She stated they did not have discussions about specific quality data at the [PAC], and she stated that the quality committee (PAC) was "not a very active committee."

On 05/13/2025 at 1:20 PM, the Vice President of Corporate Compliance/Risk Management/Quality indicated that unless there was a concern or issue, the Quality Department would not discuss quarterly quality information with the board/governing body. She additionally confirmed that the governing body were not aware of all of the other functions of the QAPI (PAC) committee.

A review of Millinocket Regional Hospital's Professional Affairs Committee meeting minutes for 2024 revealed that the Professional Affairs Committee only met two (2) times in 2024 (03/01/2024 & 12/09/2024) and that no physician was present for either of the two (2) Professional Affairs Committee meetings.

Board of Trustees meeting minutes were reviewed for 12/09/2024, 01/27/2025, 02/24/2025, 06/24/2024, 07/29/2024, 09/16/2024, 10/28/2024, 03/31/2025 and the meeting minutes did not reveal evidence of the discussion of any specific QAPI data. The meeting minutes revealed a section titled, "Professional Affairs/Corporate Compliance committee, and each of the reviewed meeting minutes revealed either of the following statement, "...No pressing issues to bring to the Board...," or "...The committee did not meet since the last Board meeting..." One (1) of the meeting minutes did not mention the Professional Affairs/Corporate Compliance Committee at all.

The Vice President of Corporate Compliance/Risk Management/Quality confirmed on 05/14/2025 at 11:12 AM that the department directors were supposed to be reporting quality data to her but were failing to do so, she confirmed that the governing body was not discussing QAPI at board meetings.

During a telephone interview with Board Member #1 on 05/14/2025 at 1:33 PM, when Board Member #1 was questioned regarding why the governing body/board meeting minutes from the past two (2) (02/24/2025 & 03/31/2025) board meetings did not show any information from quality, he stated the board, "must not have talked about any of it." When Board Member #1 was questioned regarding why the PAC committee meeting minutes for 2024 did not show evidence that there was any discussion of quality measures during the PAC meetings, he stated it sounded to him like they (the PAC), "hadn't done a quality discussion at those meetings." He confirmed that that it was his responsibility to review the quality information from the Professional Affairs Committee and take it to the board at the board meeting.

During an in-person interview on 05/15/2025 at 10:24 AM. The Vice President of Corporate Compliance/Risk Management/Quality stated the managers were not providing quality information to her. She stated she had asked for quality data and stated some of the managers were good about doing it and some "just don't know what to do." She stated she had offered to help the department managers to develop quality measures, but "they [the department managers] are just not doing it." She stated she had escalated her concerns about this to the Chief Executive Officer, ("CEO"). She stated the plan was that if the managers didn't report their quality data, [the department managers] would have to come in person to the Professional Affairs Committee meeting to explain why, "but that did not happen."

During the in-person interview on 05/15/2025 at 10:24 AM, the Vice President of Corporate Compliance/Risk Management/Quality confirmed that she attended all of the Professional Affairs Committee meetings, and stated she ran the meetings. She stated that less than half of the hospital's quality data was presented to board members during the PAC meetings. She stated it was the board members' responsibility to bring the quality data from the PAC meetings to the governing body at the board meetings. She stated the board members didn't get any of the quality data at the board/governing body meetings, and stated [the board members] just get the "30,000 feet" if there was any concern. She stated QAPI data didn't flow up to the board at all unless there was a concern. She stated only the governing body members that sit on the PAC committee had input on QAPI measures, and she indicated this only included two (2) board members - Board Member #1, and the Board President.

A document titled, "Quality Summary," was provided to the survey team on 05/15/2025 by the hospital's Vice President of Corporate Compliance/Risk Management/Quality. A review of the document revealed the following information:
-No Quality information was reported for Med-Surg for Quarter #3 2023, Quarter #1 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Lab for Quarter #3 2024, Quarter #4 2024
-No Quality information was reported for Housekeeping for Quarter #1 2025
-No Quality information was reported for the Emergency Room ("ER") also known as the Emergency Department ("ED") for Quarter #1 2024, Quarter #2 2024
-No Quality information was reported for Rehab for Quarter #3 2024,
-No Quality information was reported for Dietary for Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Operating Room for Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-Quality information was blank for the Pharmacy or Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, & Quarter #4 2024
-No Quality information was reported for Cardiopulmonary for Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025

On 05/15/2025 at 10:24 AM the Vice President of Corporate Compliance/Risk Management/Quality reviewed the above information with the survey team and confirmed the information was correct and that no quality data was reported by these departments during these quarters.

On 05/15/2025 at 11:03 AM the Board President (President of the Board of Trustees also known as the hospital's governing body) confirmed during an in-person interview that she was the president of the board and a member of the PAC. She indicated that she was responsible for bringing the information from the PAC to the board meetings. She stated the information about quality that they got at the PAC meetings were information about the quality plan, who had reported their quality data and who hadn't, as well as what the plan was to receive the data that hadn't been reported. She stated she did not recall seeing a lot of the actual quality reports themselves. She stated it was typically only if there was an issue. She stated quality wasn't reviewed at every PAC meeting, and she stated specific quality measures were not shared with the board each quarter. She stated she did not recall the specific quality measures being shared at the board meetings in a "long time," and over the past 10 years the board had left, "all of the operation things to the administration team." She stated the board got a "30,000 foot view of everything quality," to try to steer the direction without, "being in the middle of day to day stuff." She added that the board designated the CEO as the person responsible for all of the, "operational stuff." She stated the board, "has been so heavily focused on finance we have run out of time to do everything else," and she stated that as the president of the board, she did not know that many departments had not reported quality data for most of [2024].

On 05/15/2025 at 11:13 AM the Board President reviewed the document titled, "Quality Summary" with the surveyor which included a review of the following data:
-No Quality information was reported for Med-Surg for Quarter #3 2023, Quarter #1 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Lab for Quarter #3 2024, Quarter #4 2024
-No Quality information was reported for Housekeeping for Quarter #1 2025
-No Quality information was reported for the Emergency Room ("ER") also known as the Emergency Department ("ED") for Quarter #1 2024, Quarter #2 2024
-No Quality information was reported for Rehab for Quarter #3 2024,
-No Quality information was reported for Dietary for Quarter #4 2024, & Quarter #1 2025
-No Quality information was reported for the Operating Room for Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025
-Quality information was blank for the Pharmacy or Quarter #1 2024, Quarter #2 2024, Quarter #3 2024, & Quarter #4 2024
-No Quality information was reported for Cardiopulmonary for Quarter #2 2024, Quarter #3 2024, Quarter #4 2024, & Quarter #1 2025

Following the review, the Board President stated she was not aware that quality data was not reported by these departments in the above quarters. The Board President stated the board was not aware of the missing quality data either.

Based on document review, observations, and interviews, the hospital failed to demonstrate that it has established a clearly explained procedure for the submission of a patient's written or verbal grievance to the hospital.

Findings:

The Patient Rights information provided to patients of the hospital states in part, "I have the right to be informed of the facility's grievance procedure and also to appeal to an external agency, which is posted."

The Vice President of Corporate Compliance/Risk Management/Quality was interviewed on 5/14/2025 at 3:30 PM and was asked what a patient would receive when asking for the hospital's grievance procedure. The Vice President of Corporate Compliance/Risk Management/Quality thought it was posted at reception desks. When checking at the Internal Medicine practice reception desk in the hospital and at the desk at the main hospital reception area, she confirmed that this information was not posted.

A copy of a "Patient Notice" was found posted outside the door of the Chief Financial Officer (not in a patient care area easily accessible to patients and families) which includes information on how a patient can raise a concern, complaint, or grievance, but this Notice includes information which conflicts with the hospital's "Patient Grievance Policy." The undated hospital "Patient Grievance Policy" states in part that a "follow-up letter outlining the findings of the investigation shall be provided to the complainant. This letter is to be prepared and sent as soon as practicable, but in all cases, within 30 days of the completion of the investigation. If additional response time is required, the complainant must be notified by phone of the delay and the circumstances warranting the extension." The "Patient Notice, " however, states "You can expect to a reasonable response time, usually 7 days."

The Vice President of Corporate Compliance/Risk Management/Quality confirmed this discrepancy at the time of the observation.

Based on document review, observations, and interviews, the hospital failed to meet the specified time frames in its grievance process for review of grievances and the provision of responses for five (5) of five (5) patient grievances reviewed (Patients #56 - #60).

Findings:

The undated hospital "Patient Grievance Policy" states in part that a "follow-up letter outlining the findings of the investigation shall be provided to the complainant. This letter is to be prepared and sent as soon as practicable, but in all cases, within 30 days of the completion of the investigation. If additional response time is required, the complainant must be notified by phone of the delay and the circumstances warranting the extension."

On 5/14/2025 at 3:45 PM, a sample of five (5) patient grievances were reviewed with the Vice President of Corporate Compliance/Risk Management/Quality. All five (5) patients received responses later than 30 days after the grievance was received by the hospital.

-A grievance from Patient #56 was received on 1/6/2025, and the hospital sent a response letter to the patient on 2/26/2025.

-A grievance from Patient #57 was received on 1/19/2025, and the hospital sent a response letter to the patient on 2/21/2025.

-A grievance from Patient #58 was received on 1/19/2025, and the hospital sent a response letter to the patient on 2/26/2025.

-A grievance from Patient #59 was received on 5/24/2024, and the hospital sent a response letter to the patient on 7/2/2024.

-A grievance from Patient #60 was received on 8/27/2024, and the hospital sent a response letter to the patient on 10/9/2024.

The Vice President of Corporate Compliance/Risk Management/Quality confirmed in this interview that all these responses were mailed beyond the 30 days specified in the hospital policy, and none of these patients were contacted to inform them that additional time would be required.