HospitalInspections.org

Based on document reviews and interviews, the hospital's Governing Body failed to ensure:

1. The Medical Staff are appointed and reappointed in accordance with the Medical Staff and Hospital bylaws.
2. That patient care was provided by a Doctor determined to have concerns related to practicing medicine while impaired.
3. That the Medical Staff Office conducted periodic appraisals and evaluated peer review data.

Findings:

Failure to approve medical staff bylaws and other medical staff rules and regulations. The Governing Body failed to ensure that the Medical Staff Office followed the Medical Staff bylaws for the required approval signatures contained in nine (9) of nine (9) reviewed credential files. (Refer to A-0048 for details).

Failure to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. The Governing Body failed to ensure that the Medical Staff have an accountable and reliable processes to initiate the process and investigate, analyze, and address concerns regarding an impaired Doctor. This failure allowed the Human Resources Department and the Chief Executive Officer to allow this Doctor to work thirty-three (33) shifts and possibly have affected patient care, without review from the required Ad Hoc/Provider Health Committee. (Refer to A-0049 for details).

Failure to ensure the criteria for selection are individual character, competence, training, experience, and judgment. The Governing Body failed to ensure that the Medical Staff's credentialing file contained the following: Peer review and periodic appraisals for application approval for nine (9) of nine (9) files reviewed. (Refer to A-0050 for details).

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

Based upon document reviews and interviews, the Governing Body failed to ensure that the Medical Staff Office followed the Medical Staff bylaws for the required approval signatures contained in nine (9) of nine (9) reviewed credential files.

Findings:

The "York Hospital Medical Staff Bylaws and Regulations", last revised in 05/2019 states, in part, "All those eligible under these Bylaws, who have delineated clinical privileges, and who seek to have patient care responsibilities, must make application for appointment and reappointment to either the Medical Staff. Appointments and reappointments are the legal right and responsibility of the Board of Trustees of the Hospital and will be based on the findings and recommendations of the Bylaws & Credentials Committee and the Medical Executive Committee (MEC). ... The completed application, with supporting documents, shall be forwarded to the Medical Staff Office. After the application has been processed and verifications completed, the Department Chief of the Department in which the applicant seeks clinical privileges will review the application to determine if he or she meets the criteria of education, training, and experience for membership and the clinical privileges requested and make his or her recommendation. The application and all supporting material shall then be sent to the Bylaws and Credential Committee for evaluation and recommendation."

In addition, "The Board shall consider the recommendations for reappointment or non-reappointment and shall direct Administration to notify the applicant, and if reappointed, shall secure his or her signed agreement to be governed by these Bylaws, Rules & Regulations, and Policies & Procedures. In the case of non-reappointment or change in clinical privileges, the Staff member has the right to exercise or waive his or her right to Fair Hearing as provided in the Bylaws of York Hospital. The Board shall not take action (denial, or reduction in privileges) in opposition to MEC recommendation on any reappointment without a prior Joint Conference with the MEC."

On 01/09/2025 at 1:06 PM, nine (9) Medical Staff were chosen and their credentialing files were reviewed with the Medical Staffing Office Coordinator.
- There was no documented evidence of signed Requested Privileges form by Department Chief, Bylaws and Credentials Committee, Medical Executive Committee or Board of Trustees for the reviewed Medical Staff.

The Medical Staffing Office Coordinator stated the following:
- There has been brainstorming. It was in the plan of correction that I was to obtain the signatures;
- I wasn't a part of writing the plan of corrections but was told about it;
- We started going back to the beginning to the older files that had not been signed;
- COVID changed everything and it sounds bad but I got out of the habit [of getting the required signatures] and haven't gotten back into that;
- It is very important that signatures were completed and that is a function of my role;
- I can't offer an explanation; and
- I did not bring the files for them to sign.

On 01/09/2025 at approximately 3:00 PM, an interview was conducted with the Director of Compliance and Privacy in regard to the missing signatures. He stated the following:
- I started the audit; and
- I stopped everything because I realized how badly broken the operation was.

Based on document reviews and interviews, the Governing Body failed to ensure that the Medical Staff have an accountable and reliable processes to initiate the process and investigate, analyze, and address concerns regarding an impaired Doctor (Doctor #9). This failure allowed the Human Resources Department and the Chief Executive Officer to allow Doctor #9 to work thirty three (33) shifts and possibly have affected patient care, without the review from the required Ad Hoc/Provider Health Committee.

Findings:

The "York Hospital Medical Staff Bylaws and Regulations", last revised in 05/2019 states, in part,

"A. The provision of quality patient care is of primary importance to York Hospital, its Board of Trustees and its Medical Staff. It is recognized that practitioners who are suffering from physical or mental impairments may compromise the quality of patient care. York Hospital has developed this procedure to help identify, monitor and address practitioners with impairments. It is the policy of York Hospital to encourage disclosure by practitioners of any impairment which might affect the ability to safely practice medicine, to assist such practitioners in obtaining necessary treatment and, when appropriate, to provide reasonable accommodations to allow such practitioners to continue the practice of medicine.

B. Impaired practitioner is any practitioner suffering from a physical or mental illness, excessive use or abuse of drugs or alcohol, or deterioration due to the aging process which might impair his or her ability to practice medicine with a reasonable degree of skill and safety.

Ad Hoc/Provider Health Committee:

C. Appointment: There shall be a minimum of three (3) but no more than five (5) providers on an Ad Hoc/Provider Health Committee, appointed as necessary by the Chair of the Medical Executive Committee when there are reasonable grounds for review. The Medical Executive Committee will determine if there is a reasonable ground to convene.

D. Reasonability: The Provider Health Committee shall assist the Medical Executive Committee in the monitoring of the clinical performance of individuals with delineated clinical privileges. The Committee shall act as a resource for any Impaired Practitioner and may recommend treatment, counseling, etc. If any information is brought to the attention of the Provider Health Committee indicating that a practitioner is or may be impaired, the Committee or a member thereof may interview the provider and offer or recommend treatment, further evaluation or modification/restrictions to the practitioner's practice. The practitioner may also be referred to the Provider Health Program of the Maine Medical Association. The Provider Health Committee shall have no authority to impose any discipline or mandate any action involving the Provider. However, if the practitioner does not accept the Committee's assistance or recommendations the Committee shall report their findings and recommendations to the President of the Medical Staff.

E. Reports to the Provider Health Committee: All members of the Medical Staff and employees of York Hospital are encouraged to consult with the Medical Staff President and/or the Hospital President if there are reasonable grounds to suspect that another member of the Medical Staff is impaired. Members of the Medical Staff are also encouraged to disclose to the Committee, or a member thereof, their own physical or mental conditions which might impair their ability to safely practice medicine. In the absence of a sitting Provider Health Committee the Medical Staff President can be contacted.

F. Confidentiality: All reports by third parties and all discussions between a practitioner and the Provider Health Committee or a member thereof shall be kept confidential. The Committee shall report to the Medical Executive Committee, identifying the impaired practitioner anonymously and summarizing the actions recommended by the Committee and the actions taken by the impaired practitioner. These reports shall be maintained in confidence by the Medical Executive Committee in accordance with Maine State Statutes.

G. Reportability: Neither the fact that an Impaired practitioner seeks assistance from the Provider Health Committee nor any action undertaken by the practitioner as a result of discussions with the Provider Health Committee shall be reportable to the National Practitioner Data Bank, the Maine Board of Licensure in Medicine, the Maine Board of Osteopathic Licensure or other appropriate licensing board as a disciplinary or adverse clinical privilege action. Likewise, as long as the Impaired practitioner has cooperated with the Provider Health Committee, such matters shall not be reportable by the Provider Health Committee to any other committee or officer of the Medical Staff or York Hospital/ However, the fact that a practitioner seeks assistance or enters into a treatment program shall not preclude an investigation and possible adverse action by other appropriate or Medical Staff committees or officers under the Medical Staff Bylaws.

H. Subsequent Action: Report to the President of the Medical Staff or Chief Executive Officer: If a practitioner who is suspected of being impaired has refused to cooperate with the Provider Health Committee or has declined to accept the assistance or recommendations of the Committee, the Committee shall report its findings and its recommendations to the President of the Medical Staff or the Hospital President . The Medical Staff President and/or Hospital President shall meet with the practitioner to discuss the matter.

I. Action by Medical Staff President and/or Hospital President: If the practitioner still refuses to accept the recommendations of the Provider Health Committee, the Medical Staff President and/or Hospital President may recommend one or more of the following actions:
1. A requirement that the practitioner undergo treatment as a condition of continued Medical Staff privileges;
2. Restrictions on the practitioner's clinical privileges;
3. Suspension or termination of the provider's Medical Staff membership;
4. A request that the practitioner be evaluated by a provider or other appropriate health care professional, selected by the Hospital, who is not a member of the Hospital's Medical Staff;
5. A requirement that the practitioner submit periodic health status reports from his/her personal provider or health care professional, certifying that the practitioner remains able to safely practice medicine; or
6. No further action.

Reinstatement: A member of the Medical Staff who has taken a leave of absence, due to impairment, from the Medical Staff either voluntary or involuntary, or who has been suspended from the Medical Staff, must submit a request for reinstatement.

The following information will be requested by the Hospital President and/or Credentials Committee:
1. A letter from an involved treatment center which covers the following:
a) Description of the impairment;
b) Current status of the impairment;
c) Description of the treatment, and
d) Statement of the long term prognosis.
2. A letter from the impaired staff member's personal provider covering the four points listed in (1) above and:
a) Personal provider's opinion of the effect of impairment on Staff Member's professional performance;
b) Personal provider's statement that the impairment has been treated and that no adverse impact is anticipated; and
c) Any additional pertinent information.
3. A letter from the impaired Staff Member which covers the following:
a) Description of the impairment;
b) Provider's opinion as to whether the impairment is treated and whether professional performance has been affected; and
c) Statement that Staff Members will accept periodic medical evaluations at the request of Administration, Medical Staff President, Credentials Committee.

Board of Trustees and/or the appropriate department chiefs. The evaluation is to be performed by a provider qualified by education, training and experience to care for an individual with the condition for which the impaired staff member was treated, who has been chosen by or is acceptable to York Hospital.

A member of the Medical Staff who has taken a leave of absence, due to impairment, from the Medical Staff either voluntary or involuntary, or who has been suspended from the Medical Staff, must submit a request for reinstatement. The following information will be requested by the Hospital President and/or Credentials Committee:
1. A letter from an involved treatment center which covers the following:
a) Description of the impairment;
b) Current status of the impairment;
c) Description of the treatment, and
d) Statement of the long term prognosis.
2. A letter from the impaired staff member's personal provider covering the four points listed in (1) above and:
a) Personal provider's opinion of the effect of impairment on Staff Member's professional performance;
b) Personal provider's statement that the impairment has been treated and that no adverse impact is anticipated; and
c) Any additional pertinent information.
3. A letter from the impaired Staff Member which covers the following:
a) Description of the impairment;
b) Provider's opinion as to whether the impairment is treated and whether professional performance has been affected; and
c) Statement that Staff Members will accept periodic medical evaluations at the request of Administration, Medical Staff President, Credentials Committee, Board of Trustees and/or the appropriate department chiefs. The evaluation is to be performed by a provider qualified by education, training and experience to care for an individual with the condition for which the impaired staff member was treated, who has been chosen by or is acceptable to York Hospital.

Q. York Hospital may request periodic status reports covering all points in item (2) above.

R. York Hospital will have the right to evaluate the impaired Staff Member for a period of time after the Staff Member is reinstated to the Medical Staff.

S. If at any point during the process of evaluation, rehabilitation or reinstatement the provider refuses/fails to comply with this procedure he/she may be summarily suspended in accordance with the standards and procedures established in the Bylaws ... ."

On 01/09/2025 at 11:02 AM, Doctor #1 stated the following during an interview:
- We had an impaired provider but [he/she] is no longer on staff;
- This was back in July and [he/she] ended up taking time off;
- [He/She] got letters of support and returned to patient care and then didn't show up for the shift; and
- [He/She] was employed by the hospital.

On 01/09/2025 at 1:06 PM, nine (9) Medical Staff were chosen and their credentialing files were reviewed with the Medical Staffing Office Coordinator. The following was identified when Doctor #9's credentialing file was reviewed:
- The Director of Quality stated there are no quality files for the medical staff;
- The Medical Staffing Office Coordinator stated she had heard there was a concern but did not receive any information about that;
- She heard through the grapevine a concern that [Doctor #9] wasn't able to be located [by staff] in the ED;
- She heard that when [Doctor #9] was located there was additional questioning about whether [he/she] was under the influence;
- It was determined that [he/she] was not but I don't know how that was decided;
- This occurred between February through May [of 2024];
- She deactivated [him/her] in the database because she received information from Human Resources; and
- They stated that it was an ending of [his/her] contract, but is not sure when that happened.

On 01/10/2025 at 8:50 AM, the Chief Human Resources Officer, Director of Compliance and Privacy, Medical Staff President (as of 09/2024) and the Chief Executive Officer were interviewed by a surveyor and Physician Consultant surveyor in regard to Doctor #9.

On 01/10/2025 at 9:17 AM, the Chief Human Resources Officer stated:
- This situation happened in March of 2024; and
- There is no question of [his/her] impairment.

The timeline for Doctor #9, per the Chief Human Resources Officer, is as follows:
- On 03/18/2024, nursing leadership completed a "York Hospital Provider Incident Form" stating that on that day, Doctor #9 could not be located for approximately forty-five (45) minutes during the scheduled shift;
- Eventually, [he/she] was located but staff felt [he/she] appeared slightly disheveled and seemed "off";
- Later that same day, the Chief Human Resources Officer, the Chief Administrator and the nurse leader met with Doctor #9;
- [He/She] admitted to leaving the unit to "take a break" but will not do that again without notifying staff;
- "No further action" was noted;
- On 05/09/2024 at 2:07 PM, an email from Doctor #9's [supervisor] was sent to the (former) Chief Medical Officer;
- The supervisor stated, in part, that he was notified of Doctor #9 calling out for several shifts in a row due to sickness;
- He stated that Doctor #21 was called by Doctor #9. Doctor #21 expressed concerns about [him/her] and getting possible help for drug or alcohol problems;
- Doctor #20 remained concerned about Doctor #9's conduct;
- In the email, he also noted that another staff member came forward on 05/01/2024, stating that when they were talking with Doctor #9, the smell alcohol was present;
- Doctor #9 worked at the hospital on the following days in May (05/01/2024, 05/16/2024 - 05/18/2024, 05/20/2024, 05/26/2024 - 05/28/2024 and 05/31/2024), for a total of ten (10) shifts;
- On 05/29/2024 at 12:42 PM, the (former) Chief Medical Officer sent an email to Chief Human Resources Officer, the Chief Administrator and the Human Resources Director;
- He stated that he was made aware that morning that a staff member noticed that Doctor #9 had facial flushing and smelled of alcohol on Sunday [05/26/2024] while working with patients, but was not escalated further;
- There were concerns about the clinical decision making for a patient he would bring it forward to the (former) Medical Staff President;
- Following that email, there was no documented evidence that the Medical Staff Office was made aware of any concerns for patient care related to the possible impairment of Doctor #9;
- Doctor #9 continued to work at the hospital, caring for patients on the following days in June and early July (06/01/2024 - 06/04/2024, 06/07/2024 - 06/11/2024, 06/14/2024, 06/16/2024 - 06/18/2024, 06/21/2024, 06/24/2024, 07/01/2024, 07/07/2024 and 07/09/2024), for a total of eighteen (18) shifts;
- On 07/18/2024, the Chief Human Resources Officer called Doctor #9 in regard to what was going on for [him/her];
- In part, it was noted that Doctor #9 was dealing with "bouts of alcohol", "anxiety", it was not the job [he/she] signed up for and did not think that [he/she] could do the job anymore;
- Following the phone call where Doctor #9 confirmed that [he/she] was unable to care for patients, there was no documented evidence that the Medical Staff Office was made aware;
- Doctor #9 was told to take some time off;
- On 08/14/2024, Doctor #9 provided a letter from his Doctor stating that [he/she] was safe to return to work without restrictions;
- Doctor #9 continued to work at the hospital, caring for patients on the following days in August (08/18/2024 - 08/20/2024 and 08/26/2024 - 08/27/2024), for a total of five (5) shifts; and
- The last shift Doctor #9 worked was on 08/27/2024, with no documented evidence of any concerns or documented discussions in his credential file;
- There was no documented evidence that the Human Resources Department or the Chief Executive Officer of the hospital relayed any concerns to the Medical Staff Office and could not show evidence that the Medical Staff Bylaws for a possibly impaired Doctor were followed; and
- The Chief Executive Officer stated that he sent in some information to the Maine Board of Medicine but could not recall when that was done but was able to show that the Maine Board of Medicine received the information on 09/09/2024.

On 01/10/2025 at 9:43 AM, the Director of Compliance and Privacy confirmed there was no committee that was initiated, as required per the bylaws.

On 01/10/2025 at 9:49 AM, the Medical Staff President (as of 09/2024) stated that the [Medical Staff President] needs to be made aware of this type of situation.

On 01/10/2025 at 9:59 AM, the Chief Executive Officer stated that [the Director of the Department for Doctor #9] was fully aware.
When asked if the Medical Staff President was notified of this situation with Doctor #9, he stated that he doesn't have anything in his files about speaking to [the Medical Staff President].

When asked if he agreed that the Medical Staff President would need to be made aware of a physician who is impaired, he stated, "You are probably accurate, but I would have to go check the bylaws."

The AdHoc/Provider Health Committee, appointed by the Chair of the Medical Executive Committee, were not aware of any concerns and could therefore, not initiate the proper review. There were also several Doctor's involved who were aware of Doctor #9's impairment and did not bring their concerns, as encouraged in the bylaws, to the Medical Staff President and/or the Hospital President.

Hospital leadership and Human Resources were aware for approximately one hundred and ten (110) days that Doctor #9 was caring for patients at the hospital during thirty-three (33) shifts knowing the significant concerns regarding [his/her] impairment.

Based on document reviews and interviews, the Governing Body failed to ensure that the Medical Staff's credentialing file contained the following: Peer review and periodic appraisals for application approval for nine (9) of nine (9) files reviewed (Doctor #1, #6, #9, #17 - #20, Nurse Practitioner ("NP") #1 and #2).

Findings:

The "York Hospital Medical Staff Bylaws and Regulations", last revised in 05/2019 states, in part, "All those eligible under these Bylaws, who have delineated clinical privileges, and who seek to have patient care responsibilities, must make application for appointment and reappointment to either the Medical Staff. Appointments and reappointments are the legal right and responsibility of the Board of Trustees of the Hospital and will be based on the findings and recommendations of the Bylaws & Credentials Committee and the Medical Executive Committee. The Board may appoint only those practitioners who are judged by their peers to be of good character, qualified, and competent in their respective fields. Application for membership on the Staff shall be presented in writing on a prescribed form which shall state the qualifications and references of the applicant and also signify his or her agreement to abide by the Bylaws, Rules & Regulations, and Policies & Procedures of the Staff and the Hospital as they may then exist or may be amended from time to time. In the process of the initial application for appointment, and in subsequent applications for reappointment, the applicant shall provide personal attestations, and give permission for the Hospital to obtain the following information (from the primary source whenever feasible): 1. Primary verification for appointment and reappointment includes: ... 7. Three peer references regarding clinical skills and competence. At reappointment, two peer references regarding clinical skills and competence ... 15. Results of Hospital review of any patient, staff or professional complaints and review of any notification given to the practitioner or disciplinary actions taken related to such review. 16. Review of quality measures. 17. Record of professional performance and conduct at other institutions where the individual holds, or has held, privileges to practice."

In addition, "The completed application, with supporting documents, shall be forwarded to the Medical Staff Office. After the application has been processed and verifications completed, the Department Chief of the Department in which the applicant seeks clinical privileges will review the application to determine if he or she meets the criteria of education, training, and experience for membership and the clinical privileges requested and make his or her recommendation. The application and all supporting material shall then be sent to the Bylaws and Credential Committee for evaluation and recommendation. Each recommendation concerning the reappointment of a Staff member and the clinical privileges to be granted upon reappointment shall be based upon such member's professional competence and clinical judgment in the treatment of patients, his or her compliance with the Bylaws, Rules & Regulations and Policies & Procedures, quality of care, peer review, participation in required Medical Staff activities, professional behavior and citizenship, ethics, medical records quality, continuing education, and on the information collected pursuant to items 1 through 17 specified previously in Section 6 of this Article.

On 01/08/2025 at 8:46 AM, Doctor #1 was interviewed in regard to the credentialing process. The following was stated:
- I couldn't find evidence of [Ongoing Professional Practice Evaluation] "OPPE" [This identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges via the Medical Staff chapter requirements] or [Focused Professional Practice Evaluation] "FPPE" [A process whereby the medical staff evaluates the privilege-specific competence of the practitioner that lacks documented evidence of competently performing the requested privilege(s) at the organization];
- We really need to execute the OPPE and FPPE;
- As far as any ongoing reporting, I have not seen that information;
- For new candidates, there is a page application, verifications, and the usual housekeeping actions that are done;
- Evaluations for new Medical Staff, I don't feel like it happened:
- When I came on board, I had completed three (3) or (6) months, and no feedback was provided;
- I can't say as though I recall seeing anything specific for quality for the providers file since their last credentialing; and
- The credentialing and re-credentialing needs to be more robust, as there is no chair signature.

On 01/09/2025 at 9:02 AM, Doctor #4 was interviewed. He stated the following:
- I have never worked in a place that doesn't have OPPE and FPPE; and
- I look at it as an opportunity as doing things that we have not seen done at this institution.

On 01/09/2025 at 1:06 PM, nine (9) Medical Staff were chosen and their credentialing files were reviewed with the Medical Staffing Office Coordinator. There was no documented evidence of the following in nine (9) of nine (9) of the Medical Staff files:
- Results of a hospital review of any patient, staff or professional complaints and review of any notification given to the practitioner or disciplinary actions taken related to such review; and
- Record of professional performance and conduct at other institutions where the individual holds, or has held, privileges to practice.

On 01/09/2025 at approximately 1:15 PM, the Director of Quality stated the following in regard to the requirements for their peer reviews, professional performance or notifications of any disciplinary actions in their credentialing file, which the hospital refers to as the "Quality File":
- As far as the quality file for providers, we don't have any quality files. We don't have those programs set up and we don't have a process set up;
- I have been here two years and we have not done any OPPE's or FPPE's;
- We have no data to provide for at least the last two (2) years; and
- We do have letters from peer review, I do not know what they are for and I don't recall ever using them for credentialing.

On 01/09/2025 at 2:37 PM, the Medical Staffing Office Coordinator was asked how she knew that the Medical Staff were qualified for the privileges they were requesting at the hospital. She said, "I don't have an answer for that."

Based on document reviews and interviews, the hospital failed to provide a written notice of its determination regarding a grievance in accordance with their policy for three (3) of five (5) patients reviewed who filed grievances (Patients 1G, 4G, and 5G).

Findings:

The hospital's "Patient Complaints and Grievances" policy and procedure, last approved 12/2024, states in part, "To establish procedures to respond, review and resolve patient grievances and complaints as required by the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation. CMS defines a grievance as a written or verbal complaint, not resolved at the time of the complaint by the staff present, regarding the patient's care, abuse or neglect, issues related to compliance with the CMS Conditions of Participation."

The procedure for responding is defined, in part, "A written (email/mail) acknowledgement to the patient or patient's representative within 7 business days of receipt of the written grievance and/or conversation with patient or representative...and a written (email/mail) response will be given to the patient or representative within 30 business days from date of receipt."

1. On 1/22/2024, the hospital received a grievance from Patient 1G. As of 1/13/2025, there was no evidence of written a written response and determination within thirty (30) business days of receipt of the grievance.

2. On 11/18/2024, the hospital received a grievance from Patient 4G. As of 1/13/2025, there was no evidence of a written response and determination within thirty (30) business days of receipt of the grievance.

3. On 11/18/2024, the hospital received a grievance from Patient 5G. As of 1/13/2025 there was no evidence of a written response and determination within thirty (30) business days of receipt of the grievance.

On 1/10/2025 at 9:45 AM, the Compliance and Privacy Director confirmed that the hospital had failed to comply with its policy on the above grievances.

Based on document reviews and interviews, the hospital failed to ensure medical and nursing staff, who were involved in patient restraints, had completed the required restraint training for six (6) of six (6) doctors and three (3) of nine (9) who were involved with patient restraints (Doctor #10 - #15) (Registered Nurses #1 - #3).

Findings:

The hospital's "Use of Restraints for Non-Violent/Non Self-Destructive Behaviors" policy and "Use of Restraints for Violent/Self-Destructive Behaviors" policies, last approved in 1/2022, both state in part for providers, "Providers ordering restraints will receive restraint education according to medical staff bylaws and the current policy during Medical Staff Orientation with the Quality & Risk Department and/or Healthstream. Restraint training will be provided through HealthStream or face to face with the education department to any caregiver responsible for applying restraints," and for staff, "On-going training and evaluation for competency of the assessment/reassessment, safe use, application and release occurs annually for all staff who applies restraints."

1. Doctor #10 and Doctor #11 were involved in the care of the following patient who was restrained:

- Patient 1R was in restraints from 1/04/2024 - 1/05/2024. Violent restraints were applied at 4:30 AM on 1/04/2024 and removed at 11:00 AM on 1/04/2024. Non-violent restraints were then applied at 11:00 AM on 1/04/2024 and removed at 9:30 AM on 1/05/2024.

The surveyor requested to review the restraint training records of Doctor #10 and Doctor #11.

As of 1/13/2025, there was no evidence provided to the surveyor that indicated Doctor #10 and Doctor #11 had completed annual training on restraints.

2. Doctor #12, Doctor #13 and Registered Nurse ("RN") #1 were involved in the care of the following patient who was restrained:

- Patient 2R was in restraints from 7/09/2024 - 7/10/2024. Non-violent restraints were applied at 5:30 PM on 7/09/2024 and removed at 10:00 AM on 7/10/2024.

The surveyor requested to review the restraint training records of Doctor #12, Doctor #13 and RN #1.

As of 1/13/2025, there was no evidence provided to the surveyor that indicated Doctor #12, Doctor #13 and #4 and RN #1 had completed annual training on restraints.

3. Doctor #14 was involved in the care of the following patients who were restrained:

- Patient 3R was in restraints on 9/28/2024. Non-violent restraints were applied at 6:40 AM on 9/28/2024 and removed at 9:21 AM on 9/28/2024.
- Patient 4R was in restraints on 6/30/2024. Non-violent restraints were applied at 1:00 PM on 6/30/2024 and removed at 9:00 PM on 6/30/2024.
- Patient 5R was in restraints on 12/28/2024. Violent restraints were applied at 8:17 PM on 12/28/2024 and removed at 10:40 PM on 12/28/2024.

RN #2 and RN #3 were also involved in the care of Patient 4R who was in restraints on 6/30/2024.

The surveyor requested to review the restraint training records of Doctor #14 and RN #2 and RN #3.

As of 1/13/2024, there was no evidence provided to the surveyor that indicated Doctor #14, RN #2, and RN #3 had completed annual training on restraints.

3. Doctor #15 was involved in the care of Patient 5R who was in restraints on 12/28/2024.

The surveyor requested to review the restraint training records of Doctor #15.

As of 1/13/2025, there was no evidence provided to the surveyor that indicated Doctor #15 had completed annual training on restraints.

On 1/13/2025 at 11:40 AM, the Chief Nursing Officer confirmed that Doctor #10 - Doctor #15 and RN's #1 - #3 were not in compliance with hospital policy regarding restraint training.

Based on document review and interviews, the Condition of Participation for Quality Assessment and Performance Improvement ("QAPI") was not met as evidenced by the hospital's failure to ensure that its QAPI Program reflected the hospital's patient population, identified opportunities for improvement based on the collection of data and to identify any Performance Improvement projects for 2024, based on high-risk or problem-prone areas that affect health outcomes and patient care. There was no evidence that they considered the incidence, prevalence, and severity of problems in those areas and that the Governing Body failed to ensure that the QAPI Program reflects the complexity of the hospital's organization and services.

The hospital failed to ensure that it incorporated quality indicator data into the hospital's QAPI Program. (See A-0273 for details)

The hospital failed to ensure that Quality Program activities were based on high-risk, high-volume, or problem-prone areas that affect health outcomes and patient care. There was no evidence that they considered the incidence, prevalence, and severity of problems in those areas. (See A-0283 for details)

The hospital failed to identify any Performance Improvement projects that had been identified in 2024. (See A-0297 for details)

The hospital's Governing Body failed to ensure that the QAPI Program reflects the complexity of the hospital's organization and services and involves all hospital department and services (including those services furnished under contract or arrangement). (See A-0308 for details)

There was no documented evidence that the Governing Body had taken full responsibility for the hospital-wide QAPI Program. (See A-0309 for details)

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

Based on document reviews and interviews, the hospital failed to ensure that it incorporated quality indicator data into the hospital's Quality Assessment and Performance Improvement ("QAPI") Program.

Findings include:

The "York Hospital QAPI Plan" for 2024 states, in part, "Data collection is the basis for all performance improvement activities and provides a means of measuring performance through which informed decisions can be made. Data is collected for a comprehensive set of performance measures based on a priority basis in order to:
o Establish a baseline when a process is implemented or redesigned
o Identify the process performance measure
o Describe the dimensions of the performance relevant to functions, processes, and outcomes
o Identify areas for improvement including patient outcomes
o Determine if the changes in a process have met the objectives
o Implement a strategy for maintaining the effectiveness of the redesigned process over time
o Collect data as a part of continuing measurement and work prioritization, and may include process and outcomes measures
Performance measurements (indicators) data obtained through:
o Use of process or outcome indicators (as part of monitoring and evaluation activities), utilization and financial monitors, and adverse-event or occurrence monitors.
o Benchmarking or comparative data, such as local, state, regional, or national utilization patterns related to specific procedures, mortality rates and aggregated clinical outcome compliance rates.
o Studies or continuous monitoring of the cost of poor quality, patient and staff complaints and recommendations, and focus-group findings on the community's perception of the cost and quality of York Hospital services."

In addition, "The Quality Department will assist with the coordination of data, which is available throughout the facility in order to develop a consistent flow of information. All designated services of the hospital and Medical Staff will be responsible for participating in the data collection processes for each of their key performance areas and quality improvement projects. When high volume cases are sampled, an appropriate sample size is to be determined and used."
"The organization has a systematic process for assessing the collected data (measurement) in order to determine whether the newly designed processes result in performance improvements. The assessment will look at the performance of the process over time and make comparisons to external resources as appropriate. Ultimately, the assessment will determine the success of performance improvement by: identifying if new processes have met the elements of design. Identifying whether existing processes are stable and meet the level of expected performance. Assisting in setting priorities for opportunities of improvement in existing processes. Evaluating the effects of changes in the process to determine if improvements have resulted in the desired outcome or resulted in undesirable variations in performance. Comparing statistical data over time to determine if collection is systematic and accurate. Reviewing situations where the assessment of the data reveals a problem with individual performance; The medical staff or department leader uses the findings according to the medical staff bylaws, rules and regulations, or other appropriate human resource guidelines."

01/09/2025 11:20 AM, the Director of Quality was asked about the reporting of QAPI data. He stated they only report when he asks for the data, he tries to have them report yearly. He also stated he recognizes that they have a problem here with the way things are done here. He further stated they had a quality control person but since they left the facility, they are struggling to rebuild the program.

01/09/2025 1:05 PM, the Administrative Director of Laboratory Services was asked about QAPI. He stated that the only time data they have been tracking is reported to Quality is when they ask for it. He was unaware if the data submitted was represented at the QAPI meetings.

Based on document reviews and interviews, the hospital failed to ensure that Quality Assessment and Performance Improvement ("QAPI") program activities were set based on high-risk, high-volume, or problem-prone areas that affect health outcomes and patient care. There was no evidence that they considered the incidence, prevalence, and severity of problems in those areas.

Findings:

The "York Hospital QAPI Plan" for 2024 states, in part, "All areas of the organization will take a systematic approach for identifying trends, problems, or variations in services. The leaders of the service and staff members are responsible for setting priorities to improve already well operating processes, or to reduce variation or eliminate undesirable outcomes in current processes. The primary focus will be on those processes that need to be improved with high risk, high volume, or problem prone. Additionally, areas with new process, technologies or changes in the standard of care may also be areas of focus. In cases where priorities need to be set, assistance may be obtained from the Quality Committee or the service's leader. When opportunities for improvement of performance are determined, an action plan should reflect the following items:
o Identification of the process to be improved and establishment of priorities if more than one process for improvement has been identified.
o Comparison of improvement plan to the organization's mission and goals/objectives for conformity.
o Determination of whether the action requires testing. If testing is required, a strategy will be formulated which addresses how, when, where, and by whom.
o Assessment of the data following testing or action to determine if change has improved the performance or if a new design is necessary.
o Determination of the line of responsibility for implementation of the improvement (ultimately the responsibility lies with the organization's leaders to ensure that improvement has been accomplished.)."

On 01/08/2025 at 11:38 AM, the Director of Quality was asked about the scope of their projects and stated the following:
- Invasive cardiology is done at York Hospital and would be considered the most dangerous for patients; and
- There have been no performance improvement activities in that area.

On 01/08/2025 at 1:04 PM, Doctor #2 stated the following in regard to improvement projects:
- Our Quality Department has had a lot of [staff] losses;
- It is hard to devote time to quality projects;
- We have wanted to start a few but we have not been able to get it off the ground;
- We need to know how to get one going;
- It has been two (2) or three (3) years [since we have had projects]; and
- It is probably a lower priority than it has ever been.

On 01/09/2025 at 8:45 AM, the Director of Quality stated that Provider projects "Didn't happen".

On 01/13/2025 at 3:11 PM, the Chief Nursing Officer was asked about projects. She confirmed that they have an opportunity in that area.

Based on document reviews and interviews, the hospital failed to ensure that the Quality Assessment and Performance Improvement ("QAPI") identified Performance Improvement projects in 2024.

Findings include:

The "York Hospital QAPI Plan" for 2024 states, in part, "To fulfill this commitment, the Quality Assurance and Performance Improvement (QAPI) plan at York Hospital is designed to assess patient care and other support processes important to health and safety in a systematic, ongoing manner, identify improvement opportunities, and to develop action plans and interventions in a timely manner. This organization-wide written plan provides guidance for York's overall quality improvement program, including identifying and implementing opportunities to improve the quality of care, as well as other measures of organizational performance."

In addition, "Performance Improvement plans that have been approved by the Quality Committee will have action plans that have been tested or implemented, and the results are to be communicated at least annually to the Quality Committee. If the action has been determined to be ineffective, a new action is to be planned and tested. To coordinate the performance improvement information activities throughout the hospital, the Quality and Risk Management Department will have access to and receive all performance improvement activities information. The Chairperson of each committee, the Medical Staff department President, and Leaders will share information among the appropriate patient services, committees, professionals, and/or leadership in the hospital/Medical Staff when applicable. The Chairperson of the Quality Committee or designee will report performance improvement activities to the Medical Executive Committee through the Quality Committee minutes annually. Based in part upon the annual reappraisal report prepared by the Quality Department, the Quality Committee will conduct a review of the Quality and Patient Safety Plan on an annual basis. This will include a review of the distinct performance improvement projects being conducted, the reasons for conducting these projects, and measurable progress achieved. The evaluation of the plan's effectiveness will be documented in the minutes. Specific recommendations will be sent to all applicable committees, Medical Staff departments and patient services in the organization as needed."

On 01/08/2024, the Quality Improvement data was reviewed. The following was identified:
- There are five (5) areas in which data is being reviewed (Length of Stay, Sepsis, Hand Hygiene, Falls and Ambulatory Access); and
- There was no documented evidence of Performance Improvement projects.

On 01/08/2025 at 3:07 PM, Doctor #3 was asked about performance improvement projects. He/She stated that we are looking to have a formal process for performance improvement. As it is, I don't believe that it exists.

On 01/09/2025 at 9:02 AM, Doctor #4 was asked about performance improvement projects. He/She stated, "Unfortunately, there has not been any dedicated Quality Improvement."

On 01/09/2025 at 11:02 AM, Doctor #6 was asked about performance improvement projects. He/She stated they were a recent hire but was not aware of [performance] initiatives prior to my arrival.

01/09/2025 11:20 AM, the Director of Quality was asked about performance improvement projects. He stated that the projects are tracking the Length of Stay, Sepsis, Ambulatory Access, Falls, and Hand Hygiene.

On 01/13/2025 at 3:11 PM, the Chief Nursing Officer was asked about performance improvement projects. She confirmed that they have an opportunity in that area.

Based on document reviews and interviews, the hospital's Governing Body failed to ensure that the Quality Assessment and Performance Improvement ("QAPI") Program reflects the complexity of the hospital's organization and services and involves all hospital department and services (including those services furnished under contract or arrangement).

Findings include:

The "York Hospital QAPI Plan" for 2024 states, in part, "The Board of Trustees of York Hospital bears the ultimate responsibility for assuring the quality and effectiveness of patient care services provided by the medical staff members, clinical staff, and support staff.

o The Board will ensure that the improvement program reflects the complexity of the hospital's organization and services; that it involves all hospital departments and services; and focuses upon indicators related to improved health outcomes and the prevention and reduction of medical errors.
o The Board of Trustees must ensure that the hospital-wide quality and performance improvement program efforts address priorities for improved quality of care and patient safety; and all improvement actions are evaluated.
o The Board of Trustees will require that objective measures be used to gauge the quality of care and services are provided.
o The Board of Trustees will receive reports of hospital- wide performance improvement activities; they will review the findings, actions and results from the performance improvement activities in order to assess the plan's efficiency and effectiveness.
o The Board of Trustees will allocate adequate resources for measuring, assessing, also improving, and sustaining performance in key quality processes. Also reducing risk to patients through assignment of personnel and providing adequate time for personnel to participate in performance improvement activities. Adequate information services and data management systems will be supplied to facilitate collection and analysis of data.
o The Board of Trustees will assure training and education to all Leaders, and subsequently their staff, on the processes that contribute to improved patient safety and patient outcomes."

On 01/09/2024, the Board of Trustees minutes, provided for 2024, were reviewed. The following was identified:
- On 02/29/2024, it was noted that Board of Trustee #1 was the Chairman of the Quality Committee;
- On 04/25/2024, Board of Trustee ("BOT") #1 stated that in regard to QAPI, they have been talking about structure as they reassess and move forward and that the[QAPI] minutes reflect the ongoing success of this approach;
- On 06/27/2024, BOT #1 stated that the [QAPI] minutes are available in the Board Packet;
- On 08/29/2024, BOT #1 was absent but the Chief Nursing Officer ("CNO") stated that the [QAPI] minutes are available in the Board Packet; and
- On 10/31/2024, BOT #1 stated that the minutes are very thorough and review our discussions and presentations. It is very positive to know a number of benchmarks are being used to measure our quality measures.

There was no documented evidence that the Governing Body discussed the QAPI program in any of the meetings, other than being provided the Hospital Quality Committee Minutes.

On 01/09/2024, the Hospital Quality Committee ("HQC") minutes, provided for 2024, were reviewed. The following was identified:
- On 01/09/2024, the HQC was informed of the proposed 2024 goals, including: Hospital-wide length of stay, Hospital-wide Sepsis CMS Bundle Compliance, Hand Hygiene compliance, Hospital Falls reduction, and Improve Ambulatory Access;
- On 02/13/2024, the HQC was provided information on the five (5) areas they are monitoring;
- On 03/12/2024, the HQC was provided information on one (1) of the areas they are monitoring;
- On 04/09/2024, the HQC was provided information on the five (5) areas they are monitoring;
- On 05/14/2024, the HQC was provided information on three (3) areas they are monitoring, however there was a request from a committee member that there be an outpatient discussion on quality initiatives;
- On 06/14/2024, the HQC was provided information on the five (5) areas they are monitoring;
- On 08/13/2024, the HQC was told that their QAPI updates and performance reports were going to be sent via email;
- On 09/10/2024, the HQC was told that their QAPI updates and performance reports were going to be sent via email;
- On 10/07/2024, the HQC was provided information on four (4) of the five (5) areas they are monitoring; and
- On 12/10/2024, the HQC was provided information on four (4) of the five (5) areas they are monitoring.

Throughout the HQC minutes for 2024 that were provided, there was no documented evidence that BOT #1 attended an HQC meeting or participated in any way.

On 01/09/2025 at 11:29 AM, Doctor #7 was interviewed in regard to QAPI for a contracted service. The following was identified:
- Well, we don't do a lot;
- We had locums and staffing issues and then we have had a little trouble getting into the system but we do have some of the peer review information; and
- I am not aware of reporting to Quality.

On 01/13/2025 at 2:45 PM, the CNO stated that she thinks they are conducting [Performance Improvement] PI, but thinks they need to streamline the data.

Based on document reviews and interviews, the hospital failed to provide documented evidence that the Governing Body has taken full responsibility for the hospital-wide Quality Assessment and Improvement Process ("QAPI") Program.

Findings:

The "York Hospital QAPI Plan" for 2024 states, in part, "The Board of Trustees of York Hospital bears the ultimate responsibility for assuring the quality and effectiveness of patient care services provided by the medical staff members, clinical staff, and support staff.

o The Board will ensure that the improvement program reflects the complexity of the hospital's organization and services; that it involves all hospital departments and services; and focuses upon indicators related to improved health outcomes and the prevention and reduction of medical errors.
o The Board of Trustees must ensure that the hospital-wide quality and performance improvement program efforts address priorities for improved quality of care and patient safety; and all improvement actions are evaluated.
o The Board of Trustees will require that objective measures be used to gauge the quality of care and services are provided.
o The Board of Trustees will receive reports of hospital- wide performance improvement activities; they will review the findings, actions and results from the performance improvement activities in order to assess the plan's efficiency and effectiveness.
o The Board of Trustees will allocate adequate resources for measuring, assessing, also improving, and sustaining performance in key quality processes. Also reducing risk to patients through assignment of personnel and providing adequate time for personnel to participate in performance improvement activities. Adequate information services and data management systems will be supplied to facilitate collection and analysis of data.
o The Board of Trustees will assure training and education to all Leaders, and subsequently their staff, on the processes that contribute to improved patient safety and patient outcomes."

The Bylaws of York Hospital, last reviewed 08/26/2021, states in part, "Members of the Board of Trustees are expected to attend 75% of Committee meetings. The administrative office will maintain an attendance record for each Committee meeting. Attendance at Full Board and Committee meetings will be reviewed annually by the Executive Committee to determine continued service on the Board."

On 01/09/2024, the Board of Trustees minutes, provided for 2024, were reviewed. The following was identified:
- On 02/29/2024, it was noted that Board of Trustee #1 was the Chairman of the Quality Committee;
- On 04/25/2024, Board of Trustee ("BOT") #1 stated that in regard to QAPI, they have been talking about structure as they reassess and move forward and that the[QAPI] minutes reflect the ongoing success of this approach;
- On 06/27/2024, BOT #1 stated that the [QAPI] minutes are available in the Board Packet;
- On 08/29/2024, BOT #1 was absent but the Chief Nursing Officer ("CNO") stated that the [QAPI] minutes are available in the Board Packet; and
- On 10/31/2024, BOT #1 stated that the minutes are very thorough and review our discussions and presentations. It is very positive to know a number of benchmarks are being used to measure our quality measures.

There was no documented evidence that the Governing Body discussed the QAPI program in any of the meetings, other than being provided the Hospital Quality Committee Minutes.

On 01/09/2024, the Hospital Quality Committee ("HQC") minutes, provided for 2024, were reviewed. The following was identified:
- On 01/09/2024, the HQC was informed of the proposed 2024 goals, including: Hospital-wide length of stay, Hospital-wide Sepsis CMS Bundle Compliance, Hand Hygiene compliance, Hospital Falls reduction, and Improve Ambulatory Access;
- On 02/13/2024, the HQC was provided information on the five (5) areas they are monitoring;
- On 03/12/2024, the HQC was provided information on one (1) of the areas they are monitoring;
- On 04/09/2024, the HQC was provided information on the five (5) areas they are monitoring;
- On 05/14/2024, the HQC was provided information on three (3) areas they are monitoring, however there was a request from a committee member that there be an outpatient discussion on quality initiatives;
- On 06/14/2024, the HQC was provided information on the five (5) areas they are monitoring;
- On 08/13/2024, the HQC was told that their QAPI updates and performance reports were going to be sent via email;
- On 09/10/2024, the HQC was told that their QAPI updates and performance reports were going to be sent via email;
- On 10/07/2024, the HQC was provided information on four (4) of the five (5) areas they are monitoring; and
- On 12/10/2024, the HQC was provided information on four (4) of the five (5) areas they are monitoring.

On 01/13/2025 at 11:00 AM, BOT #2 was interviewed. She stated, in part, the following:
- We get reports from leaders, quality, medical executive, nursing, etc. and they keep us informed;
- Concerns, in regard to patient care, are not brought to the board level, but it wouldn't be ignored; and
- I do not recall any quality of care concerns.

On 01/13/2025 at 11:49 AM, BOT #1 was interviewed. She stated, in part, the following:
- I am the current Chair of the BOT and the Chair of the Quality Committee;
- In regard to QAPI, all areas of the hospital are reviewed at the meetings;
- They have four (4) - five (5) QAPI goals; and
- They have a plan to improve the process, for example, hand hygiene.

On 01/13/2025 at 2:45 PM, the CNO was asked who oversees the QAPI program to provide evidence of QAPI activities that were initiated based on data reported through the medical error/adverse event tracking system. She stated that the Chief Medical Officer ("CMO") had responsibility for Quality. Our CMO left and it got shifted to me.

In addition, the CNO stated that she thinks they are conducting [Performance Improvement] PI, but thinks they need to streamline the data.

Throughout the HQC minutes for 2024 that were provided, there was no documented evidence that BOT #1 attended an HQC meeting or participated in any way, though the expectation is to attend 75% of Committee meetings.

Based on document reviews and interviews, the hospital failed to ensure that the Medical Staff was brought to the credentialing committee with the required approval signatures, that the credential files contained any quality information and that a Doctor, who confirmed they were impaired and unable to care for patients, continued to work in the hospital.

Findings:

The hospital failed to ensure that each medical staff's credentialing file contained the required signatures for application approval for nine (9) of nine (9) files reviewed (Doctor #1, #6, #9, #17 - #20, Nurse Practitioner ("NP") #1 and #2). See A-0339 for details.

The hospital failed to ensure that each medical staff's credentialing file contained the following: Peer review and periodic appraisals for application approval for nine (9) of nine (9) files reviewed (Doctor #1, #6, #9, #17 - #20, Nurse Practitioner ("NP") #1 and #2). See A-0340 for details.

The Medical Staff Office failed to have an accountable and reliable processes to initiate the process and investigate, analyze, and address concerns regarding an impaired Doctor (Doctor #9). This failure caused the Human Resources Department to make decisions, that could have affected patient care, without the review of the Medical Executive Committee or Governing Body. See A-0347 for details.

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

REPEAT DEFICIENCY

Based on document reviews and interviews, the hospital failed to ensure that each Medical Staff's credentialing file contained the required signatures for application approval for nine (9) of nine (9) files reviewed (Doctor #1, #6, #9, #17 - #20, Nurse Practitioner ("NP") #1 and #2).

Findings:

During a recent Federal complaint survey (07/11/2024), five (5) of eight (8) Medical Staff credentialing files failed to include a signed Requested Privileges form by Department Chief, Bylaws and Credentials Committee, Medical Executive Committee or Board of Trustees.

The plan of correction, signed by the President/Chief Executive Officer on 08/02/2024 stated the following corrective measures:
- In order to ensure the Medical Staff Office and subsequently the Medical Staff itself is operating in accordance with its bylaws, the hospital will initiate an audit of all provider files (including Advanced Practice Practitioners) with a 09/06/2024 goal of completion;
- Results of this audit will be shared with the Compliance Officer, Executive Leadership, The President of the Medical Staff and Board of Trustees;
- Any corrective action steps will be completed immediately upon discovery of a deficiency;
- In addition, the Compliance Officer will randomly select and review the Medical Staff Office files of new providers joining the organization 08/04/2024;
- Immediate feedback will be provided if any deficiencies are noted with correction required within forty-eight (48) hours;
- The Compliance Officer is responsible for implementing this plan of correction.

The "York Hospital Medical Staff Bylaws and Regulations", last revised in 05/2019 states, in part, "All those eligible under these Bylaws, who have delineated clinical privileges, and who seek to have patient care responsibilities, must make application for appointment and reappointment to either the Medical Staff. Appointments and reappointments are the legal right and responsibility of the Board of Trustees of the Hospital and will be based on the findings and recommendations of the Bylaws & Credentials Committee and the Medical Executive Committee. ... The completed application, with supporting documents, shall be forwarded to the Medical Staff Office. After the application has been processed and verifications completed, the Department Chief of the Department in which the applicant seeks clinical privileges will review the application to determine if he or she meets the criteria of education, training, and experience for membership and the clinical privileges requested and make his or her recommendation. The application and all supporting material shall then be sent to the Bylaws and Credential Committee for evaluation and recommendation."

In addition, "The Board shall consider the recommendations for reappointment or non-reappointment and shall direct Administration to notify the applicant, and if reappointed, shall secure his or her signed agreement to be governed by these Bylaws, Rules & Regulations, and Policies & Procedures. In the case of non-reappointment or change in clinical privileges, the Staff member has the right to exercise or waive his or her right to Fair Hearing as provided in the Bylaws of York Hospital. The Board shall not take action (denial, or reduction in privileges) in opposition to MEC recommendation on any reappointment without a prior Joint Conference with the MEC."

On 01/09/2025 at 1:06 PM, nine (9) Medical Staff were chosen and their credentialing files were reviewed with the Medical Staffing Office Coordinator.
- There was no documented evidence of signed Requested Privileges form by Department Chief, Bylaws and Credentials Committee, Medical Executive Committee or Board of Trustees for the reviewed Medical Staff.

The Medical Staffing Office Coordinator stated the following:
- There has been brainstorming. It was in the plan of correction that I was to obtain the signatures;
- I wasn't a part of writing the plan of corrections but was told about it;
- We started going back to the beginning to the older files that had not been signed;
- COVID changed everything and it sounds bad but I got out of the habit [of getting the required signatures] and haven't gotten back into that;
- It is very important that signatures were completed and that is a function of my role;
- I can't offer an explanation; and
- I did not bring the files for them to sign.

On 01/09/2025 at approximately 3:00 PM, an interview was conducted with the Director of Compliance and Privacy in regard to the missing signatures. He stated the following:
- I started the audit; and
- I stopped everything because I realized how badly broken the operation was.

Based on document reviews and interviews, the hospital failed to ensure that each Medical Staff's credentialing file contained the following: Peer review and periodic appraisals for application approval for nine (9) of nine (9) files reviewed (Doctor #1, #6, #9, #17 - #20, Nurse Practitioner ("NP") #1 and #2).

Findings:

The "York Hospital Medical Staff Bylaws and Regulations", last revised in 05/2019 states, in part, "All those eligible under these Bylaws, who have delineated clinical privileges, and who seek to have patient care responsibilities, must make application for appointment and reappointment to either the Medical Staff. Appointments and reappointments are the legal right and responsibility of the Board of Trustees of the Hospital and will be based on the findings and recommendations of the Bylaws & Credentials Committee and the Medical Executive Committee. The Board may appoint only those practitioners who are judged by their peers to be of good character, qualified, and competent in their respective fields. Application for membership on the Staff shall be presented in writing on a prescribed form which shall state the qualifications and references of the applicant and also signify his or her agreement to abide by the Bylaws, Rules & Regulations, and Policies & Procedures of the Staff and the Hospital as they may then exist or may be amended from time to time. In the process of the initial application for appointment, and in subsequent applications for reappointment, the applicant shall provide personal attestations, and give permission for the Hospital to obtain the following information (from the primary source whenever feasible): 1. Primary verification for appointment and reappointment includes: ... 7. Three peer references regarding clinical skills and competence. At reappointment, two peer references regarding clinical skills and competence ... 15. Results of Hospital review of any patient, staff or professional complaints and review of any notification given to the practitioner or disciplinary actions taken related to such review. 16. Review of quality measures. 17. Record of professional performance and conduct at other institutions where the individual holds, or has held, privileges to practice."

In addition, "The completed application, with supporting documents, shall be forwarded to the Medical Staff Office. After the application has been processed and verifications completed, the Department Chief of the Department in which the applicant seeks clinical privileges will review the application to determine if he or she meets the criteria of education, training, and experience for membership and the clinical privileges requested and make his or her recommendation. The application and all supporting material shall then be sent to the Bylaws and Credential Committee for evaluation and recommendation. Each recommendation concerning the reappointment of a Staff member and the clinical privileges to be granted upon reappointment shall be based upon such member's professional competence and clinical judgment in the treatment of patients, his or her compliance with the Bylaws, Rules & Regulations and Policies & Procedures, quality of care, peer review, participation in required Medical Staff activities, professional behavior and citizenship, ethics, medical records quality, continuing education, and on the information collected pursuant to items 1 through 17 specified previously in Section 6 of this Article.

On 01/08/2025 at 8:46 AM, Doctor #1 was interviewed in regard to the credentialing process. The following was stated:
- I couldn't find evidence of [Ongoing Professional Practice Evaluation] "OPPE" [This identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges via the Medical Staff chapter requirements] or [Focused Professional Practice Evaluation] "FPPE" [A process whereby the medical staff evaluates the privilege-specific competence of the practitioner that lacks documented evidence of competently performing the requested privilege(s) at the organization];
- We really need to execute the OPPE and FPPE;
- As far as any ongoing reporting, I have not seen that information;
- For new candidates, there is a page application, verifications, and the usual housekeeping actions that are done;
- Evaluations for new Medical Staff, I don't feel like it happened:
- When I came on board, I had completed three (3) or (6) months, and no feedback was provided;
- I can't say as though I recall seeing anything specific for quality for the providers file since their last credentialing; and
- The credentialing and re-credentialing needs to be more robust, as there is no chair signature.

On 01/09/2025 at 9:02 AM, Doctor #4 was interviewed. He stated the following:
- I have never worked in a place that doesn't have OPPE and FPPE; and
- I look at it as an opportunity as doing things that we have not seen done at this institution.

On 01/09/2025 at 1:06 PM, nine (9) Medical Staff were chosen and their credentialing files were reviewed with the Medical Staffing Office Coordinator. There was no documented evidence of the following in nine (9) of nine (9) of the Medical Staff files:
- Results of a hospital review of any patient, staff or professional complaints and review of any notification given to the practitioner or disciplinary actions taken related to such review; and
- Record of professional performance and conduct at other institutions where the individual holds, or has held, privileges to practice.

On 01/09/2025 at approximately 1:15 PM, the Director of Quality stated the following in regard to the requirements for their peer reviews, professional performance or notifications of any disciplinary actions in their credentialing file, which the hospital refers to as the "Quality File":
- As far as the quality file for providers, we don't have any quality files. We don't have those programs set up and we don't have a process set up;
- I have been here two years and we have not done any OPPE's or FPPE's;
- We have no data to provide for at least the last two (2) years; and
- We do have letters from peer review, I do not know what they are for and I don't recall ever using them for credentialing.

On 01/09/2025 at 2:37 PM, the Medical Staffing Office Coordinator was asked how she knew that the Medical Staff were qualified for the privileges they were requesting at the hospital. She said, "I don't have an answer for that."

Based on document reviews and interviews, the hospital failed to ensure that the Medical Staff Office had an accountable and reliable processes to initiate the process and investigate, analyze, and address concerns regarding an impaired Doctor (Doctor #9). This failure caused the Human Resources Department to make decisions, that could have affected patient care, without the review of the Medical Executive Committee or Governing Body.

Findings:

The "York Hospital Medical Staff Bylaws and Regulations", last revised in 05/2019 states, in part,
"A. The provision of quality patient care is of primary importance to York Hospital, its Board of Trustees and its Medical Staff. It is recognized that practitioners who are suffering from physical or mental impairments may compromise the quality of patient care. York Hospital has developed this procedure to help identify, monitor and address practitioners with impairments. It is the policy of York Hospital to encourage disclosure by practitioners of any impairment which might affect the ability to safely practice medicine, to assist such practitioners in obtaining necessary treatment and, when appropriate, to provide reasonable accommodations to allow such practitioners to continue the practice of medicine.

B. Impaired practitioner is any practitioner suffering from a physical or mental illness, excessive use or abuse of drugs or alcohol, or deterioration due to the aging process which might impair his or her ability to practice medicine with a reasonable degree of skill and safety. Ad Hoc/Provider Health Committee:

C. Appointment: There shall be a minimum of three (3) but no more than five (5) providers on an Ad Hoc/Provider Health Committee, appointed as necessary by the Chair of the Medical Executive Committee when there are reasonable grounds for review. The Medical Executive Committee will determine if there is a reasonable ground to convene.

D. Reasonability: The Provider Health Committee shall assist the Medical Executive Committee in the monitoring of the clinical performance of individuals with delineated clinical privileges. The Committee shall act as a resource for any Impaired Practitioner and may recommend treatment, counseling, etc. If any information is brought to the attention of the Provider Health Committee indicating that a practitioner is or may be impaired, the Committee or a member thereof may interview the provider and offer or recommend treatment, further evaluation or modification/restrictions to the practitioner's practice. The practitioner may also be referred to the Provider Health Program of the Maine Medical Association. The Provider Health Committee shall have no authority to impose any discipline or mandate any action involving the Provider. However, if the practitioner does not accept the Committee's assistance or recommendations the Committee shall report their findings and recommendations to the President of the Medical Staff.

E. Reports to the Provider Health Committee: All members of the Medical Staff and employees of York Hospital are encouraged to consult with the Medical Staff President and/or the Hospital President if there are reasonable grounds to suspect that another member of the Medical Staff is impaired. Members of the Medical Staff are also encouraged to disclose to the Committee, or a member thereof, their own physical or mental conditions which might impair their ability to safely practice medicine. In the absence of a sitting Provider Health Committee the Medical Staff President can be contacted.

F. Confidentiality: All reports by third parties and all discussions between a practitioner and the Provider Health Committee or a member thereof shall be kept confidential. The Committee shall report to the Medical Executive Committee, identifying the impaired practitioner anonymously and summarizing the actions recommended by the Committee and the actions taken by the impaired practitioner. These reports shall be maintained in confidence by the Medical Executive Committee in accordance with Maine State Statutes.

G. Reportability: Neither the fact that an Impaired practitioner seeks assistance from the Provider Health Committee nor any action undertaken by the practitioner as a result of discussions with the Provider Health Committee shall be reportable to the National Practitioner Data Bank, the Maine Board of Licensure in Medicine, the Maine Board of Osteopathic Licensure or other appropriate licensing board as a disciplinary or adverse clinical privilege action. Likewise, as long as the Impaired practitioner has cooperated with the Provider Health Committee, such matters shall not be reportable by the Provider Health Committee to any other committee or officer of the Medical Staff or York Hospital/ However, the fact that a practitioner seeks assistance or enters into a treatment program shall not preclude an investigation and possible adverse action by other appropriate or Medical Staff committees or officers under the Medical Staff Bylaws.

H. Subsequent Action: Report to the President of the Medical Staff or Chief Executive Officer: If a practitioner who is suspected of being impaired has refused to cooperate with the Provider Health Committee or has declined to accept the assistance or recommendations of the Committee, the Committee shall report its findings and its recommendations to the President of the Medical Staff or the Hospital President . The Medical Staff President and/or Hospital President shall meet with the practitioner to discuss the matter.

I. Action by Medical Staff President and/or Hospital President: If the practitioner still refuses to accept the recommendations of the Provider Health Committee, the Medical Staff President and/or Hospital President may recommend one or more of the following actions:
1. A requirement that the practitioner undergo treatment as a condition of continued Medical Staff privileges;
2. Restrictions on the practitioner's clinical privileges;
3. Suspension or termination of the provider's Medical Staff membership;
4. A request that the practitioner be evaluated by a provider or other appropriate health care professional, selected by the Hospital, who is not a member of the Hospital's Medical Staff;
5. A requirement that the practitioner submit periodic health status reports from his/her personal provider or health care professional, certifying that the practitioner remains able to safely practice medicine; or
6. No further action.

A member of the Medical Staff who has taken a leave of absence, due to impairment, from the Medical Staff either voluntary or involuntary, or who has been suspended from the Medical Staff, must submit a request for reinstatement. The following information will be requested by the Hospital President and/or Credentials Committee:
1. A letter from an involved treatment center which covers the following:
a) Description of the impairment;
b) Current status of the impairment;
c) Description of the treatment, and
d) Statement of the long term prognosis.
2. A letter from the impaired staff member's personal provider covering the four points listed in (1) above and:
a) Personal provider's opinion of the effect of impairment on Staff Member's professional performance;
b) Personal provider's statement that the impairment has been treated and that no adverse impact is anticipated; and
c) Any additional pertinent information.
3. A letter from the impaired Staff Member which covers the following:
a) Description of the impairment;
b) Provider's opinion as to whether the impairment is treated and whether professional performance has been affected; and
c) Statement that Staff Members will accept periodic medical evaluations at the request of Administration, Medical Staff President, Credentials Committee, Board of Trustees and/or the appropriate department chiefs. The evaluation is to be performed by a provider qualified by education, training and experience to care for an individual with the condition for which the impaired staff member was treated, who has been chosen by or is acceptable to York Hospital.

Q. York Hospital may request periodic status reports covering all points in item (2) above.

R. York Hospital will have the right to evaluate the impaired Staff Member for a period of time after the Staff Member is reinstated to the Medical Staff.

S. If at any point during the process of evaluation, rehabilitation or reinstatement the provider refuses/fails to comply with this procedure he/she may be summarily suspended in accordance with the standards and procedures established in the Bylaws ... ."

On 01/09/2025 at 11:02 AM, Doctor #1 stated the following during an interview:
- We had an impaired provider but [he/she] is no longer on staff;
- This was back in July and [he/she] ended up taking time off;
- [He/She] got letters of support and returned to patient care and then didn't show up for the shift; and
- [He/She] was employed by the hospital.

On 01/09/2025 at 1:06 PM, nine (9) Medical Staff were chosen and their credentialing files were reviewed with the Medical Staffing Office Coordinator. The following was identified when Doctor #9's credentialing file was reviewed:
- The Director of Quality stated there are no quality files for the medical staff;
- The Medical Staffing Office Coordinator stated she had heard there was a concern but did not receive any information about that;
- She heard through the grapevine a concern that [Doctor #9] wasn't able to be located [by staff] in the ED;
- She heard that when [Doctor #9] was located there was additional questioning about whether [he/she] was under the influence;
- It was determined that [he/she] was not but I don't know how that was decided;
- This occurred between February through May [of 2024];
- She deactivated [him/her] in the database because she received information from Human Resources; and
- They stated that it was an ending of [his/her] contract, but is not sure when that happened.

On 01/10/2025 at 8:50 AM, the Chief Human Resources Officer, Director of Compliance and Privacy, Medical Staff President (as of 09/2024) and the Chief Executive Officer were interviewed by a surveyor and Physician Consultant surveyor in regard to Doctor #9.

On 01/10/2025 at 9:17 AM, the Chief Human Resources Officer stated:
- This situation happened in March of 2024; and
- There is no question of [his/her] impairment.

The timeline for Doctor #9, per the Chief Human Resources Officer, is as follows:
- On 03/18/2024, nursing leadership completed a "York Hospital Provider Incident Form" stating that on that day, Doctor #9 could not be located for approximately forty-five (45) minutes during the scheduled shift;
- Eventually, [he/she] was located but staff felt [he/she] appeared slightly disheveled and seemed "off";
- Later that same day, the Chief Human Resources Officer, the Chief Administrator and the nurse leader met with Doctor #9;
- [He/She] admitted to leaving the unit to "take a break" but will not do that again without notifying staff;
- "No further action" was noted;
- On 05/09/2024 at 2:07 PM, an email from [the Director of the Department for Doctor #9] was sent to the (former) Chief Medical Officer;
- The supervisor stated, in part, that he was notified of Doctor #9 calling out for several shifts in a row due to sickness;
- He stated that Doctor #22 was called by Doctor #9. Doctor #21 expressed concerns about [him/her] and getting possible help for drug or alcohol problems;
- Doctor #21 remained concerned about Doctor #9's conduct;
- In the email, he also noted that another staff member came forward on 05/01/2024, stating that when they were talking with Doctor #9, the smell alcohol was present;
- Doctor #9 worked at the hospital on the following days in May (05/01/2024, 05/16/2024 - 05/18/2024, 05/20/2024, 05/26/2024 - 05/28/2024 and 05/31/2024), for a total of ten (10) shifts;
- On 05/29/2024 at 12:42 PM, the (former) Chief Medical Officer sent an email to Chief Human Resources Officer, the Chief Administrator and the Human Resources Director;
- He stated that he was made aware that morning that a staff member noticed that Doctor #9 had facial flushing and smelled of alcohol on Sunday [05/26/2024] while working with patients, but was not escalated further;
- There were concerns about the clinical decision making for a patient he would bring it forward to the (former) Medical Staff President;
- Following that email, there was no documented evidence that the Medical Staff Office was made aware of any concerns for patient care related to the possible impairment of Doctor #9;
- Doctor #9 continued to work at the hospital, caring for patients on the following days in June and early July (06/01/2024 - 06/04/2024, 06/07/2024 - 06/11/2024, 06/14/2024, 06/16/2024 - 06/18/2024, 06/21/2024, 06/24/2024, 07/01/2024, 07/07/2024 and 07/09/2024), for a total of eighteen (18) shifts;
- On 07/18/2024, the Chief Human Resources Officer called Doctor #9 in regard to what was going on for [him/her];
- In part, it was noted that Doctor #9 was dealing with "bouts of alcohol", "anxiety", it was not the job [he/she] signed up for and did not think that [he/she] could do the job anymore;
- Following the phone call where Doctor #9 confirmed that [he/she] was unable to care for patients, there was no documented evidence that the Medical Staff Office was made aware;
- Doctor #9 was told to take some time off;
- On 08/14/2024, Doctor #9 provided a letter from his Doctor stating that [he/she] was safe to return to work without restrictions;
- Doctor #9 continued to work at the hospital, caring for patients on the following days in August (08/18/2024 - 08/20/2024 and 08/26/2024 - 08/27/2024), for a total of five (5) shifts; and
- The last shift Doctor #9 worked was on 08/27/2024, with no documented evidence of any concerns or documented discussions in his credential file;
- There was no documented evidence that the Human Resources Department or the Chief Executive Officer of the hospital relayed any concerns to the Medical Staff Office could not show evidence that the Medical Staff Bylaws rule for a possibly impaired Doctor were followed; and
- The Chief Executive Officer stated that he sent in some information to the Maine Board of Medicine but could not recall when that was done but was able to show that the Maine Board of Medicine received the information on 09/09/2024.

On 01/10/2025 at 9:43 AM, the Director of Compliance and Privacy confirmed there was no committee that was initiated, as required per the bylaws.

On 01/10/2025 at 9:49 AM, the Medical Staff President (as of 09/2024) stated that the [Medical Staff President] needs to be made aware of this type of situation.

On 01/10/2025 at 9:59 AM, the Chief Executive Officer stated that [the Director of the Department for Doctor #9] was fully aware.
When asked if the Medical Staff President was notified of this situation with Doctor #9, he stated that he doesn't have anything in his files about speaking to [the Medical Staff President].

When asked if he agreed that the Medical Staff President would need to be made aware of a physician who is impaired, he stated, "You are probably accurate, but I would have to go check the bylaws."

The AdHoc/Provider Health Committee, appointed by the Chair of the Medical Executive Committee, were not aware of any concerns and could therefore, not initiate the proper review. There were also several Doctor's involved who were aware of Doctor #9's impairment and did not bring their concerns, as encouraged in the bylaws, to the Medical Staff President and/or the Hospital President.

Hospital leadership and Human Resources were aware for approximately one hundred and ten (110) days that Doctor #9 was caring for patients at the hospital during thirty-three (33) shifts knowing the significant concerns regarding [his/her] impairment.

Based on document reviews, observations, and interviews, the hospital failed to meet the Condition of Participation Physical Environment as evidenced by the following:

The hospital failed to ensure air distribution systems for the Operating Room suites received preventive maintenance to include but not limited to testing, adjusting, & balancing for over seven (7) years (A-0701).

The hospital failed to ensure preventive maintenance and repairs were scheduled and performed in one (1) of two (2) Computed Tomography areas observed (A-0701).

The hospital failed to ensure preventative maintenance and plumbing fixtures in the kitchen of the Medical/Surgical unit were repaired and maintained sanitary in one (1) of two (2) observed Medical/Surgical unit kitchens (A-0701).

The hospital failed to ensure expired supplies were removed from circulation in York Hospital Emergency Care in Wells, and the Sterile Processing Department (A-0724).

The hospital failed to ensure humidity levels were monitored and recorded in Operating Room #3 for the entire months of February, March, April, August, September, October, and November of 2024, and part of the months of May, July, and December of 2024 (A-0726).

Please see A-0701, A-0724, & A-0726 for details.

Based on document reviews and interviews, the hospital failed to ensure: 1) That operating room air distribution systems for the Operating Room ("OR") suites received preventive maintenance to include but not limited to regular testing, adjusting, and balancing for greater than seven (7) years, for five (5) of five (5) OR's (OR #1 - 5); failed to ensure preventative maintenance to include but not limited to repairs were scheduled and performed in one (1) of two (2) Computed Tomography ("CT") areas observed (CT #2) and ensure plumbing fixtures in the kitchen of the Medical/Surgical unit were repaired and maintained in a sanitary condition in one (1) of two (2) observed Medical/Surgical unit kitchens.

Findings:

1. Operating Rooms:

York Hospital has adopted the Association of Perioperative Registered Nurses' ("AORN") standards. AORN's standard for air flow handling lists the following lists the following suites/parameters:
-Minimum Total Air Changes Per Hour: 20
-Minimum total Outdoor Air Changes: 4
-Design Temperature: 68-75 Degrees Fahrenheit
-Design Relative Humidity: 20% - 60%
-Pressure Relationship to Adjacent Areas: Positive

A Testing, Adjusting & Balancing Completion Report for the Air Distribution Systems at York Hospital Operating Rooms was reviewed and revealed that prior to the date of the initiation of this recertification survey (01/07/2025), the last time the York Hospital OR suites preventive maintenance to include but not limited to testing, adjusting, and balancing of the OR suites' air handling system was on 07/14/2017.

On 01/13/2025 at 10:57 AM an in-person interview was conducted with the Executive Director of Operations and Development, during which they confirmed that prior to the date of the initiation of this recertification survey, the OR suites' air distribution systems had not been calibrated since 2017. The Executive Director of Operations and Development stated that the hospital did not have a regular interval at which this was done, and they indicated that as far as they were aware there wasn't a standard policy or process for the regular re-calibration of air distribution equipment in the operating room.

On 01/14/2025 at 8:55 AM, a telephone interview was conducted with the hospital's Heating Ventilation and Air Conditioning ("HVAC") Contractor. The HVAC Contractor stated testing, adjusting, and balancing was important in the operating rooms because they want to confirm they are meeting the air changes required per hour, to make sure the air is moving, and that there are no contaminants from out in the hallway are being pulled into the OR suites. The HVAC Contractor stated that if air from other areas entered the OR suites, it would be an infection risk. The HVAC Contractor stated that the standard for the industry was to have preventative maintenance to include but not limited to testing, adjusting, and balancing done yearly. The HVAC Contractor confirmed that the last time they had performed preventative maintenance to include but not limited to testing, adjusting, and balancing at York Hospital was in 2017.

On 01/09/2025 at 11:03 AM, the Executive Director of Operations and Development confirmed there is no written policy or procedure that compelled staff to submit work orders for facility maintenance issues once they were discovered.

2. Computed Tomography Areas

Observation of the patient care area, CT #2, 01/07/2025 at 1:04 PM revealed the following:
- A cabinet door underneath the sink had an exposed screw sticking out in a way that could potentially cause injury;
- The handles on two (2) of the cabinets in the CT area were broken;
- The flooring in CT #2 was damaged underneath one of the hand sanitizer dispensers (due to the dispenser drippings?); and
- Broken ceiling tiles in the staff/control area of CT #2.

The Director of Imaging was present during observation and was made aware of these issues at the time of observation.

On 01/09/2025 at 11:03 AM, the Executive Director of Operations and Development confirmed there is no written policy or procedure that compelled staff to submit work orders for facility maintenance issues once they were discovered.

3. Medical/Surgical Unit

On 01/07/2025 11:59 AM, the survey team observed a water line next to the sink in the medical/surgical kitchen on the unit Biewind was folded over itself and held together with clear tape. The clear tape was soiled with an unidentified red/pink substance. The Executive Director of Operations and Development was present for the observations confirmed this was a water line.

Based on document reviews, interviews, and observations, the hospital failed to ensure expired supplies were removed from circulation at the York Hospital Emergency Care in Wells, and in the Sterile Processing Department.

Findings:

York Hospital's policy titled, "General Stockroom Inventory and Storage and Security," last revised 03/2024 states in part, " ... Outdated/expired items must be removed from supply stock and set aside for proper disposal, donation, or returned to the manufacturer if possible ... ."

On 01/08/2025 at 1:49 PM, observations were conducted in the Sterile Processing Department. The following was identified:
- It was observed that three (3) containers of Povidone Iodine Swabsticks were present in the hanger that had expired in 11/2024; and
- A supply storage hanger on one of the racks that stated "Out Dates Checked 01/11/2025".

On 01/08/2025 at 1:49 PM, the Central Sterile Coordinator confirmed these supplies were expired.

On 01/13/2025 from 10:33 AM - 12:04 PM, observations were conducted at York Hospital Emergency Care in Wells. The following was indentified:
- One (1) pair of surgical gloves on the adult code cart expired on 11/2024;
- Three (3) 22 gauge syringes were expired; and
- One (1) 18 gauge syringe in exam room #3 were expired.

The Nurse Manager present for these observations was made aware of the expired items at the time of observation.

Based on document reviews, interviews, and observations, the hospital failed to ensure humidity levels were monitored and recorded in Operating Room ("OR") #3 for the entire months of February, March, April, August, September, October, and November of 2024, and portions of the months of May, July, and December of 2024.

Findings:

The York Hospital's policy titled, "Temperature and Humidity of Surgical Services," last revised 10/2022 states in part: "...The temperature of the Operating Rooms should be from 68F - 75F with humidity from 20% to 60%. These temperatures must be intentionally adjusted for a limited time based on individual case needs ...On all days that the Operating rooms are open temperature and humidity will be logged before the first case begins...Temperature and Humidity will be logged by the housekeeper daily. On days that housekeeping is not present, temperature and humidity will be logged by the Clinical Coordinator or Charge Nurse...At any time the relative humidity of any Operating room is outside the above range Maintenance on call should be contacted and the call documented on the temperature and humidity log..."

On 01/09/2025, OR Temperature and Humidity Logs for Operating Rooms 1, 2, 3, 4, & 5 were reviewed which revealed the following:
- February 2024: No humidity data was recorded for February 2024 for OR #3
- March 2024: No humidity data was recorded for all of March 2024 for OR #3
- April 2024: No humidity data was recorded for all of April 2024 for OR #3
- May 2024: No humidity data was recorded for May 1, 2, 6, 7, 8, 9, 13, 14, 15, 16, 20, 21, 22, 23, 28, 29, 30 for OR #3.
-July 2024: No Humidity data was recorded for July 1, 2, 3, 8, 9, 10, 11, 15, 16, 17, 18, 22, 23, 24, 25, 29, 30, 31 for OR #3
- August 2024: No humidity data was recorded for all of August 2024 for OR #3
- September 2024: No humidity data was recorded for all of September 2024 for OR #3
- October 2024: No humidity data was recorded for all of October 2024 for OR #3
- November 2024: No humidity data was recorded for all of November 2024 for OR #3
- December 2024: No Humidity data was recorded for December 2, 3, 4, 5, 9, 10, 11, 12, 16, 17, 18, 19, 23, 24, 26, 30, 31

On the dates where no humidity data was recorded, it was observed that the "Humidity" spaces on the above dates were lined through on the logs, indicating the measurements were not missed.

On 01/09/2025 at 12:49 PM, an interview was conducted with the Director of Surgical Services and stated the following:
- It is important to monitor humidity in the operating room for sterility purposes and for equipment to function properly;
- The equipment has a humidity requirement for it to function; and
- The humidity levels not being monitored could be an infection risk.

On 01/10/2025 at 9:01 AM, an interview was conducted with the Director of Surgical Services and stated the following:
- The humidity detection equipment in OR #3 was out of service for the majority of 2024;
- It was not reported to me that OR #3 didn't have a working humidity reader;
- We weren't verifying the humidity logs; and
- "Looking back at the logs, it was pretty much the whole year."

On 01/10/2025 at 9:10 AM, The Director of Surgical Services confirmed that staff were drawing a line through the humidity line on the OR Temperature and Humidity Logs for OR #3 for [2024], indicating the item was looked at by staff and there was no action taken.

On 01/13/2025 at 11:52 AM, The Director of Corporate Compliance and Privacy communicated the following statement regarding humidity levels in the operating room via email , "... Heat and humidity are intimately intertwined, one affects the other and vice versa ... Humidity that is too low is a fire risk - in an OR you have anesthetic gases, lots of electrical equipment, electro-cautery devices ... between 20% - 60% is generally acceptable ... Humidity that is too high is an infection risk - pathogens thrive in a warm, moist environment..."

Based on observations, interviews, and document reviews, the hospital failed to ensure the following: 1) That the patient food storage freezer was maintained in a sanitary condition for one (1) out of three (3) patient food storage freezers observed (the freezer in the Intensive Care Unit); 2) That opened containers of prepared foods and condiments were labeled with the date in one (1) out of one (1) observed kitchen walk-in refrigerator (the walk-in refrigerator in the main hospital kitchen); and that laboratory supplies were being stored in a sanitary manner in one (1) out of one (1) observed laboratory blood bank (the blood bank located at the York Hospital main campus).

Findings:

1. Food Storage

The hospital's policy titled, "Purchasing, Receiving, Storage and Issuing of Food and Supplies," last revised 05/2024 stated in part, "...Prepared items are clearly covered, labeled [sic.], dated and stored safely to prevent contamination..."

On 01/07/2025 at 11:51 AM, during observation of the Intensive Care Unit, the survey team observed dirt, debris and an unidentified red substance on the bottom of the freezer containing patient food.

On 01/07/2025 at 11:51 AM, the Medical Surgical and Intensive Care Unit Director was notified of the condition of the freezer and confirmed that the food stored in this freezer was for patients.

2. Labeling Food and Supplies

The hospital's policy titled, "Purchasing, Receiving, Storage and Issuing of Food and Supplies," last revised 05/2024 states in part, "...Prepared items are clearly covered, labeled [sic.], dated and stored safely to prevent contamination..."

During observation of the main hospital kitchen on 01/07/2025 at approximately 2:20 PM the following was observed:
- An open container of soup, covered in plastic wrap, that was not dated, the top of the container was labeled with, "Cream of Cauliflower for Wednesday."
-Opened jars of condiments including Caesar Salad Dressing, Thousand Island Dressing, & Buffalo Wing Sauce which were not dated.

At the time of the observation, the Dining and Nutrition Staff Member confirmed that the container of soup, salad dressings, and buffalo wing sauce were not dated.

3. Blood Bank Storage

The hospital's policy titled, "Medication, Specimen, and Reagent Storage," last revised 05/2023 was reviewed and did not reveal any information related to not storing reagents directly on the ground.

On 01/08/2025 at 8:25 AM, during observation of the York Hospital Blood Bank, it was observed that a box labeled, "D-10 Hemoglobin A1C Program," was being directly stored on the floor of the Blood Bank. This product was confirmed by the Lab Administrative Director to be a reagent for labs.

At the time of the observation, the Lab Administrative Director confirmed that the reagent should not be stored on the ground.

Based on document reviews and interviews, the hospital failed to ensure the Antibiotic Stewardship Program was participating in Quality Assessment and Performance Improvement ("QAPI").

Findings:

On 01/09/2025 at 9:57 AM, the Antibiotic Stewardship Program Leader stated their last quality presentation was in August of 2022. The Antibiotic Stewardship Program Leader stated they had not reported to Quality since 2022, and stated they had asked to, but Quality hadn't prioritized it. They stated no quality data had been reported to Quality from Antibiotic Stewardship for 2 years.

On 01/09/2025 at 10:15 AM, the Director of Quality and Risk Management confirmed the Antibiotic Stewardship Program hadn't reported any data to Quality since 2022, that they were not integrated with QAPI as of 01/09/2025, the date of the interview, and confirmed the last time the Antibiotic Stewardship Program participated in QAPI was in 2022.