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Tag No.: A0043
Based on staff interviews and record reviews, the governing body failed to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients (A0049).
Tag No.: A0049
Based on staff interviews and record reviews, the governing body failed to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This deficient practice had the potential to affect any patient receiving services in the cardiology service lines, intensive care units, cardiac catheterization suite or operating suite.
Findings include:
1. The facility census of open-heart procedures had increased from an average of fifty per year to 240 in 18 months.
Interview with Staff Q on 10/03/23 at 11:06 AM revealed the facility had stopped their open-heart program on 09/28/23 due to concerns identified in an internal review. Staff Q said a contract specialist group had been hired to evaluate the facility's open-heart program and associated services including nursing in the intensive care unit (ICU), surgical nursing services, and the cardiac catheterization, interventional cardiology services unit.
Interview with Staff Q revealed the facility had begun an open-heart program in 2006 with two physicians who were no longer employed at the facility. Staff Q said that the facility recruited an interventional cardiologist who was skilled, experienced and credentialed to perform valve repairs in the cardiac catheterization lab, a transaortic valve replacement (TAVR), and also recruited two cardiothoracic surgeons to perform open-heart procedures and provide support for the advanced valve procedures in the cardiac catheterization lab. Staff Q said the facility implemented the change for the cardiac services in early 2022 and the volume of procedures and the volume of patients increased.
Interview with Staff Q on 10/10/23 at 10:30 AM revealed the previous open-heart surgery program's annual volume had been 50 patient procedures and the recent volume had been 240 patient procedures in 18 months.
Interview with Staff X on 10/10/23 at 11:14 AM revealed the community population had challenges such as high rates of chronic disease and co-morbidities that were present in younger patients which adjusted the risk levels to higher values than previously seen and with the higher acuity there were more events that required advanced care.
Interview with Staff FF on 10/10/23 at 11:36 AM revealed the facility needed to address education of all care teams with hands-on training ahead of procedures, mandatory training, and better monitoring of staff ratios until confidence could be established. Staff FF said he had been present when the open-heart program was initially begun, and all the staff had gone to another facility where they learned about the procedure, process, and protocols within an active, successful program. Staff FF said no such action was taken with this recent program advancement.
Review of ten patient records sampled from a recent six-month time frame revealed patients had multiple diagnoses, co-morbid and chronic, complex conditions that required advanced cardiac procedures and care. Review of the sample revealed there were events of patient procedure complications within the cardiac catheterization suite, the cardiac surgical services, and the ICU which required use of the advanced equipment, including balloon pumps, ventricular assist devices and life-support apparatuses. Review of physician and nursing documentation revealed the sampled patients required emergent interventions with advanced equipment and complicated care protocols of multiple medications, fluids, close monitoring, quick action, and progressive clinical judgment for rapid changes in condition.
Interview with Staff AA on 10/11/23 at 12:50 PM revealed cardiac operating room (OR) staff experienced patients with elevated acuity, a change in procedure types and new provider styles, different protocols with greater demands for which OR staff felt unprepared. Staff AA said staff requested more training, but none was provided. Staff AA said provider attitudes, mannerisms and behaviors changed the environment of the OR and when events occurred nothing was explained, until de-briefing was implemented months later, and staff education consisted of an assigned article to read.
Interview with Staff Q on 10/11/23 at 1:34 PM confirmed the change in the cardiac surgery program brought the use of robotics to open-heart, and increased volume of surgical patients, new service lines, and surgeons with more advanced skills and abilities than had been seen in previous years' cardiothoracic surgeons.
Interview with Staff JJ on 10/12/23 at 9:03 AM revealed there was minimal information about the preferences of the new cardiac surgeons and there was no hands-on training or simulation to prepare for the newer techniques and equipment. Staff JJ said the OR environment changed with the provider's attitude and demanding demeanor which added stress and uncertainty for staff who were unsure of expectations. Staff JJ said staff turnover occurred for a variety of reasons and the loss of skilled, knowledgeable staff, coupled with the lack of management support made the environment feel unsafe and when patient acuity rose along with adverse events and patient mortality staff confidence wavered.
Interview with Staff I on 10/16/23 at 5:45 PM confirmed that there was no training for staff with the new providers in simulation or hands-on training with established operating programs prior to the introduction of the additional processes, procedures, protocols, and providers at the facility.
The facility failed to ensure that staff had adequate training for advanced level processes and procedures when volume and acuity of cases experienced an increase as the facility added an advanced level cardiac service lines to their operation.
2. Review of the facility policy titled, Problem Reporting/Non-Retaliation applicable to all facility staff, revised 08/21/23, revealed the facility had a process for workforce members to make a good faith report of misconduct, maintaining a working environment that promotes open communication, candid discussions of workforce members problems and concerns. Review of the policy revealed the facility had a system for raising questions, suggestions, expressing problems, concerns or opinions on any issue that provided a procedure to reach a resolution. Review of the policy revealed that the organization's leadership and human resources had responsibility in the process for taking proactive measures to find resolution after receiving workforce members' opinions, concerns, and problems. Review of the policy revealed the goal of the process was to explore a resolution with a thorough and timely investigation and inform the workforce member of the final disposition.
Interview with Staff W on 10/11/23 at 11:08 AM revealed that there were investigations by human resources regarding concerns about the behavior of a provider, Staff I. Those investigations resulted in education to the provider. Staff W said that staff reported the provider's mannerisms and attitude were intimidating, with a demanding and critical style. Staff W said that the provider was educated about their tone and approach with peer to peer communication, explaining expectations ahead of procedures and allowing staff to anticipate needs.
Interview with Staff AA on 10/11/23 at 12:50 PM revealed there were concerns about provider behavior in the operating services that were reported to a manager, but no resolution was provided for the staff who reported the concern. Staff AA said some concerns were about a provider yelling at staff, moving quickly without allowing staff to anticipate actions, nor providing guidance to staff about the process and expectations in the operating room (OR). Staff AA said that months after the concerns were voiced there was an implementation of a post-case debriefing with the provider, but the culture had been too toxic for too long to correct the situation. Staff AA said that the provider commented that there should not be reporting to anyone else because the surgical team could handle the concerns and Staff AA said that since there were few employees on the open-heart team that any report would be obvious for the source and that limited staff members' interest in speaking up. Staff AA said the delay in action potentially led to the turnover of staff including the manager who was present when the problems were reported.
Interview with Staff JJ on 10/12/23 at 9:03 AM revealed there was minimal information about the preferences of the new cardiac surgeons and there was no hands-on training or simulation to prepare for the newer techniques and equipment. Staff JJ said the OR environment changed with the provider's attitude and demanding demeanor which added stress and uncertainty for staff who were unsure of expectations. Staff JJ said staff turnover occurred for a variety of reasons and the loss of skilled, knowledgeable staff, coupled with the lack of management support made the environment feel unsafe and when patient acuity rose along with adverse events and patient mortality staff confidence wavered.
In further interview on 10/12/23 Staff JJ said there was no collaboration with an outside hospital for skill building or real-time observation of the new physicians to learn and gain competence with the style and techniques of the providers as it had been done with the original open-heart program start-up. Staff JJ said the staff reported their concerns to a nursing manager, but no action was taken. Staff JJ said there was no format for communication, no meetings, no huddle groups, and surgeons blamed staff for errors. Staff JJ said that the toxic and hostile culture began to affect morale and staff were not inclined to work in the post-operative ICU setting because of the environment of uncertainty created by unclear leadership for clinical management of patients' care. Staff JJ said that the facility's focus was on increasing patient numbers and the increasing acuities were creating an unsafe environment in which staff were frustrated and ready to quit employment because they perceived no management support.
Interview with Staff O on 10/12/23 at 1:56 PM revealed the change in the cardiac surgery program brought an increase in case counts that included many critical patients with higher acuity and needs and staff were not as prepared as they should have been. Staff O said a shift in the culture as evidenced by voiced concerns about lack of training and a lack of follow-up to staff concerns left staff overwhelmed.
Interview with Staff NN on 10/12/23 at 4:30 PM revealed he/she witnessed the cardiothoracic surgeons arguing and placing conflicting orders in the ICU that created confusion and frustration for staff with patient care management. Staff NN said he/she reported their concerns about the ICU environment and activities to nursing management and received no response. Staff NN said many of the nursing middle management had changed over within the past year.
Interview with Staff LL on 10/12/23 at 2:10 PM revealed the change in cardiothoracic surgeons from the previous group to the new group in 2022 was not organized well. Staff LL said a few dry runs and demonstrations about techniques with videos to introduce topics were not enough training and staff had no meetings or collaborations with the surgeons. Staff LL said the nursing managers did not address concerns or provide leadership to guide staff collaboration for basics such as new supplies, provider requests for sutures and instruments, and preference cards for operative case carts. Staff LL said there were limited open-heart trained staff in the OR so that the source of any concerns would be obvious to the providers and staff were intimidated to complain. Staff LL said the two new providers' mannerisms could be demanding and unfriendly as evidenced by language in the OR and one of the advanced level providers left employment because of one of the provider's poor technique, methods that were difficult to anticipate, lengthy surgery times, and lack of management support.
Interview with Staff MM on 10/12/23 at 3:47 PM confirmed there were concerns among staff about the lengthy procedure times of one of the cardiothoracic surgeons and there were challenges with staff skills for use of the advanced life-sustaining equipment, and challenges with the patients' post-procedure care management when medical providers gave conflicting directions, and no one was designated to lead. Staff MM said that he/she witnessed the medical providers giving conflicting orders to ICU staff and creating confusion and frustration that as reported to the nursing manager. Staff MM said that a trend was developing with critically ill patients experiencing subtle changes in condition requiring staff to have advanced clinical judgement to identify the clinical variances before a full-blown decline with poor outcomes. Staff MM said the model for patient care was not working because of a lack of active management in the ICU and staff education for care of critical patients under the advanced cardiac service line. Further interview revealed there was a decision to stop one cardiothoracic surgeon from operating after a patient experienced a complication with a balloon pump and the other cardiothoracic surgeon refused to assist with that patient due to a poor prognosis. Staff MM said both cardiothoracic surgeons were terminated on 09/28/23 after these events and concerned providers reporting about their concerns to the medical executives of the facility.
Interview with Staff X on 10/16/23 at 1:10 PM revealed that after a recent patient cardiac surgery case, on 09/26/23, that ended up being the final case prior to the closure of the open-heart program Staff X met with medical executives at the facility to report concerns about one of the cardiothoracic surgeons. Staff X said the facility's medical executives were informed about the observed deficits in the cardiothoracic surgeon's skill set that posed a threat to patient safety and decided to revoke that surgeon's privileges. Review of a memo dated 09/28/23 titled, Termination of Physician Employment Agreement, revealed the facility terminated a cardiothoracic surgeon's employment contract at the facility with that written notice.
Interview with Staff I on 10/16/23 at 5:45 PM confirmed there was staff turnover that contributed to nursing services' challenges to keep up with the increased patient volumes.
The facility failed to ensure staff concerns about provider behavior, lack of training and competency, lack of leadership and guidance in cardiac service lines, which compromised staff ability to deliver comprehensive care for cardiac service patients.
3. Review of the facility's governing body meeting minutes, known as the Adena Health System Board Trustees Meeting minutes, for months starting in March 2022 through the present revealed no information about the challenges with the cardiology, cardiothoracic, open-heart surgical, critical care nursing services, medical management, or progress of the advancement of the cardiac services withing the facility. Further review of the meeting minutes revealed during several Adena Health System Board Trustees Meeting the Executive Team would enter into an Executive Session. There were no meeting minutes detailing what was discussed during the Executive Session.
On 10/17/23, meeting minutes for the Executive Sessions were requested. Interview with Staff S via email communication on 10/17/23 at 4:12 PM revealed there were no meeting minutes from the Executive Sessions. Further emailed communication with Staff S on 10/19/23 at 3:08 PM revealed the Executive Sessions were just verbal conversations.
The facility failed to ensure that ongoing issues within cardiovascular services, the cardiac catheterization lab, the cardiothoracic surgical services, and the intensive care unit were addressed by the governing body.
This deficiency represents non-compliance investigated under Substantial Allegation OH00146661.
Tag No.: A0347
Based on interview and record review, the facility failed to ensure the medical staff was well organized and accountable to the governing body for the quality of the medical care provided to the patients. This deficient practice had the potential to affect any patient receiving services in the cardiology service lines, intensive care units, cardiac catheterization suite or operating suite.
Findings include:
Interview with Staff Q on 10/03/23 at 11:06 AM revealed the facility had stopped their open-heart program on 09/28/23 due to concerns identified in an internal review. Staff Q said a contract specialist group had been hired to evaluate the facility's open-heart program and associated services including nursing in intensive care unit (ICU), surgical nursing services, and the cardiac catheterization, interventional cardiology services unit. Interview with Staff Q revealed the facility had begun an open-heart program in 2006 with two physicians who were no longer employed at the facility. Staff Q said the facility implemented changes to the cardiac services in early 2022 and the volume of procedures and the volume of patients increased.
Review of ten patient records sampled from a recent six-month time frame revealed patients had multiple diagnoses, co-morbid and chronic, complex conditions that required advanced cardiac procedures and care. Review of the sample revealed there were events of patient procedure complications within the cardiac catheterization suite, the cardiac surgical services, and the ICU which required use of the advanced equipment, including balloon pumps, ventricular assist devices and life-support apparatuses. Review of physician and nursing documentation revealed the sampled patients required emergent interventions with advanced equipment and complicated care protocols of multiple medications, fluids, close monitoring, quick action and progressive clinical judgment for rapid changes in condition.
Interview with Staff Q on 10/10/23 at 10:30 AM revealed the previous open-heart surgery program's annual volume had been 50 patient procedures and the recent volume had been 240 patient procedures in 18 months.
Interview with Staff FF on 10/10/23 at 11:36 AM revealed the facility needed to address education of all care teams with hands-on training ahead of procedures, mandatory training, and better monitoring of staff ratios until confidence could be established. Staff FF said he had been present when the open-heart program was initially begun, and all the staff had gone to another facility where they learned about the procedure, process, and protocols within an active, successful program. Staff FF said no such action was taken with this recent program advancement.
Interview with Staff AA on 10/11/23 at 12:50 PM revealed cardiac operating room (OR) staff experienced patients with elevated acuity, a change in procedure types and new provider styles, different protocols with greater demands for which OR staff felt unprepared. Staff AA said staff requested more training, but none was provided. Staff AA said provider attitudes, mannerisms and behaviors changed the environment of the OR and when events occurred nothing was explained, until de-briefing was implemented months later, and staff education consisted of an assigned article to read.
Interview with Staff JJ on 10/12/23 at 9:03 AM revealed there was minimal information about the preferences of the new cardiac surgeons and there was no hands-on training or simulation to prepare for the newer techniques and equipment. Staff JJ said the OR environment changed with the provider's attitude and demanding demeanor which added stress and uncertainty for staff who were unsure of expectations. Staff JJ said staff turnover occurred for a variety of reasons and the loss of skilled, knowledgeable staff, coupled with the lack of management support made the environment feel unsafe and when patient acuity rose along with adverse events and patient mortality staff confidence wavered. Staff JJ said there was no format for communication, no meetings, no huddle groups, and surgeons blamed staff for errors. Staff JJ said that the toxic and hostile culture began to affect morale and staff were not inclined to work in the post-operative ICU setting because of the environment of uncertainty created by unclear leadership for clinical management of patients' care. Staff JJ said that the facility's focus was on increasing patient numbers and the increasing acuities were creating an unsafe environment in which staff were frustrated and ready to quit employment because they perceived no management support.
Interview with Staff LL on 10/12/23 at 2:10 PM revealed the change in cardiothoracic surgeons from the previous group to the new group in 2022 was not organized well. Staff LL said a few dry runs and demonstrations about techniques with videos to introduce topics were not enough training and staff had no meetings or collaborations with the surgeons. Staff LL said the nursing managers did not address concerns or provide leadership to guide staff collaboration for basics such as new supplies, provider requests for sutures and instruments, and preference cards for operative case carts. Staff LL said there were limited open-heart trained staff in the OR so that the source of any concerns would be obvious to the providers and staff were intimidated to complain. Staff LL said the two new providers' mannerisms could be demanding and unfriendly as evidenced by language in the OR and one of the advanced level providers left employment because of one of the provider's poor technique, methods that were difficult to anticipate, lengthy surgery times, and lack of management support.
Interview with Staff MM on 10/12/23 at 3:47 PM confirmed there were concerns among staff about the lengthy procedure times of one of the cardiothoracic surgeons and there were challenges with staff skills for use of the advanced life-sustaining equipment, and challenges with the patients' post-procedure care management when medical providers gave conflicting directions, and no one was designated to lead. Staff MM said that he/she witnessed the medical providers giving conflicting orders to ICU staff and creating confusion and frustration that was reported to the nursing manager. Staff MM said there was a decision to stop one cardiothoracic surgeon from operating after a patient experienced a complication with a balloon pump and the other cardiothoracic surgeon refused to assist with that patient due to a poor prognosis. Staff MM said both cardiothoracic surgeons were terminated on 09/28/23 after these events and concerned providers reporting about their concerns to the medical executives of the facility.
Interview with Staff NN on 10/12/23 at 4:30 PM revealed he/she witnessed the cardiothoracic surgeons arguing and placing conflicting orders in the ICU that created confusion and frustration for staff with patient care management. Staff NN said he/she reported their concerns about the ICU environment and activities to nursing management and received no response. Staff NN said many of the nursing middle management had changed over within the past year.
Interview with Staff X on 10/16/23 at 1:10 PM revealed that after a recent patient cardiac surgery case, on 09/26/23, that ended up being the final case prior to the closure of the open-heart program Staff X met with medical executives at the facility to report concerns about one of the cardiothoracic surgeons. Staff X said the facility's medical executives were informed about the observed deficits in the cardiothoracic surgeon's skill set that posed a threat to patient safety and decided to revoke that surgeon's privileges. Review of a memo dated 09/28/23 titled, Termination of Physician Employment Agreement, revealed the facility terminated a cardiothoracic surgeon's employment contract at the facility with that written notice.
The facility failed to ensure that medical staff were organized in delivery and evaluation of the service line when medical staff disagreed about the appropriateness of service, failed to provide guidance and direction to staff, to influence the technical quality of staff and procedures, and future direction impacting those services.
This deficiency represents non-compliance investigated under Substantial Allegation OH00146661.