Pennsylvania Department of Health
SHARON REGIONAL HEALTH SYSTEM
Patient Care Inspection Results

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Minimal Citation - No Harm Minimal Harm Actual Harm Serious Harm
SHARON REGIONAL HEALTH SYSTEM
Inspection Results For:

There are  176 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.
SHARON REGIONAL HEALTH SYSTEM - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:

This report is the result of an unannounced onsite complaint investigation (PA00069648) completed on March 29, 2024, at Sharon Regional Health System. It was determined the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 482-Conditions of Participation for Hospitals.

On March 6, 2024, at approximately 2:16 PM, an Immediate Jeopardy (IJ) was identified for the CoP Physical Environment. The IJ was removed on March 6, 2024, at approximately 6:02 PM after the State Survey Agency verified the hospital implemented sufficient immediate corrective action to address the IJ.

On March 7, 2024, at approximately 3:50 PM, an Immediate Jeopardy (IJ) was identified for the CoP for Infection Control. The IJ was removed on March 15, 2024, at approximately 5:24 PM after the State Survey Agency verified the hospital implemented sufficient immediate corrective action to address the IJ.

The facility failed to provide an acceptable removal plan and implement immediate corrective action prior to exit.




 Plan of Correction:


482.12 CONDITION GOVERNING BODY:Not Assigned
There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ...

Observations:

Based on review of facility documentation, medical records (MR) and employee interview (EMP), it was determined the Governing Body failed to maintain adequate supplies to provide surgical services for 29 of 29 surgical cases reviewed (MR20-MR48).

Review of facility documentation revealed vendor holds resulted in the inability to obtain necessary supplies for 29 surgical cases (MR20-MR48). Cardiac cases for MR49 and MR50 were attempted but unable to be completed due to the lack of necessary supplies. Despite being aware of the lack of necessary surgical supplies, the hospital failed to implement actions to address the non-payment issues.

An Immediate Jeopardy was called at 3:53 PM on March 28, 2024, when it was identified the facility did not have a process in place to ensure supplies were available for routine and emergent procedures. Immediate Jeopardy (IJ) was identified for the CoP Governing Body.

The facility failed to provide an acceptable removal plan and implement immediate corrective action prior to exit on March 29, 2024.


Cross Reference:
482.12(d) Institutional Plan and Budget
482.12(e)(1) Contracted Services
482.21(e)(4) Providing Adequate Resources





 Plan of Correction - To be completed: 04/23/2024

To remove immediate threat to patients, advanced scheduling has been discontinued and shorter-term scheduling implemented for elective cases. Patients will not be booked for elective procedures without the required supplies and equipment on hand or delivery confirmed.

Upon receipt of the Immediate Jeopardy (IJ) finding, the hospital President immediately notified the Chairperson of the Board. The Board of Directors (BOD) received a report of the findings and corrective action plans at a special meeting April 8, 2024. The President notified the BOD of the findings/documents received 4/10/2024 and 4/12/2024.

Upon receipt the Corporate Regional President, Steward Chief Medical Officer, Vice President of Quality and Regulatory were notified of the IJ finding. In addition, the Senior Leadership Team reviewed the current patient census, services needed, staffing and supplies and determined that safe care can be provided at that time.

A group was immediately convened consisting of the Senior Leadership Team and Corporate Leaders to review and assess surgical services and cardiology services to determine if there were any current supplies that have not been replaced as well as to review the current census, services needed, and staffing.

Departmental Directors / Managers conducted an inventory of supplies and developed a list of items needed to provide services in their department including assuring appropriate par levels.

At the daily huddle effective 3/29/24 and ongoing, all directors/managers are reporting issues related to supplies and equipment. The list of supplies needed to support the services affected is being forwarded to the Sharon Regional Medical Center Senior Leadership team for sourcing of needed supplies. Daily safety huddle report sheet was edited to include assessment and verification of appropriate supply levels for each department, any surgical/procedural cancelations.

In addition, the Chief Medical Officer of Steward Health Care and the system Vice President of Materials Management review the list to source the supplies from the current or alternate vendor.
The equipment and supply vendor lists were categorized by immediately available for delivery from vendor, an alternate vendor, or another facility.

As of 3/29/24 and going forward, OR and procedural cases are reviewed daily to assure that required equipment has been sourced.
All issues with supplies are under continuous monitoring and tracking by procedural department managers and their staff.

Additional communication / education was provided to all staff and providers directing them to report any supply and/or equipment shortage to their manager or Director or via the hospital's online incident reporting system. This will be reinforced during daily shift huddles and leadership rounding and staff must attest in writing to reviewing the communication / education.

An inventory plan is in place and consists of: utilization of the Inventory list of storerooms stocked clinical supplies with current par levels from the supply module in Meditech with perpetual inventory, and items that are not currently stocked were identified. For the following departments: cardiology, radiology, CVU, ICU, Surgical Services, Endoscopy, Pharmacy and Lab, an Inventory list of special order/PO clinical-based items managed locally by department was created and this will be the focus for special order/PO/consignment.

On 3/29/24, the Regional Director of Materials Management and the Senior VP of Corporate Operation reviewed all current purchase orders for supplies necessary to maintain the clinical services cited. Once completed this list was forwarded to The Regional President, Steward Chief Medical Officer, and Corporate Vice President of Materials Management to resolve any ongoing credit issues to assure that adequate supplies are maintained, to effectively carry out the function of the hospital. At the time of booking elective cases, the perioperative team will assess to ensure all supplies needed are available. No elective case will be booked unless the supplies are confirmed to be available.

Monitoring:
Beginning on 3/31/2024, the CMO at Sharon Regional Medical Center or his designee (Administrator on Call) will check each morning with the leaders of the Department/Service to ensure that supply inventory has been assessed and is present for the safe care of patients and complete the Supply Grid. Any critical supply not present will be escalated immediately to the President of the hospital, the Regional CFO and the Executive Director of Supply Chain and/or the Senior Vice President of Corporate Operations.

Daily monitoring of supply levels in all departments by department Director/Manager or designee is occurring.

The Daily Safety Huddle report sheet was edited and team members were to include assessment and verification of appropriate supply levels for each department, any surgical/procedural cancelations, inability to accept patients in transfer.

SLT will monitor supply levels daily to assure they can meet the needs of the patients.

Any issues identified at the local level will be immediately communicated to the Corporate Supply Chain leadership team for resolution. Any issues that cannot be resolved will be communicated to the hospital president and regional president for evaluation and recommendations.

All reported concerns regarding supply issues from providers and staff both verbal, and via online incident reporting system will be collated daily by the Regional Director of Quality and communicated to the SLT.

The weekly OR schedule will be monitored by the Inventory Coordinator in collaboration with the Director of Surgical Services to assure the supplies are on hand for upcoming cases.

On a daily basis, the Regional Director of Materials Management reviews the Sharon Vendor Status grid that is maintained by her and her team. The review is to ensure we have critical supplies available from vendors and alternative sources in the event we are unable to do business with the primary vendor. If it is determined that critical supplies could impact patient safety, she escalates it to the President of the hospital, the Regional CFO and the Executive Director of Supply Chain and/or the Senior Vice President of Corporate Operations.
Any issues identified at the local level will be immediately communicated to the Corporate Supply Chain leadership team for resolution.

Any issues that cannot be resolved will be communicated to the hospital president and regional president for evaluation and recommendations.

Monitoring of all incident reports related to supply issues, patient care issues/cancellations related to supplies will be reported to the hospital President for corrective action planning/escalation when necessary.

Monitoring and Collection of Data:
In order to ensure the specific deficiencies cited remain corrected; the deficiencies do not recur, compliance with this regulatory requirement is maintained Governing Body oversight is ensured a monitoring program has been initiated. All procedures (surgical services, cardiac catheterization lab, endoscopy, and interventional radiology) will be monitored on an ongoing basis.

Numerator: total number of procedures by service line each month that were completed without encountering barriers related to needed supply

Denominator: Total number of procedures scheduled
(note: numerator and denominator excludes incidents that occur whereby the case is cancelled due to a patient centered reason eg: elevated BP, patient decision, etc)

The Regional Director of Quality will report the results monthly at the following committees: Quality and Patient Safety Committee, Medical Executive Committee and Board of Directors monthly.

Responsible Person: Hospital President
482.12(d) STANDARD INSTITUTIONAL PLAN AND BUDGET:Not Assigned
The institution must have an overall institutional plan that meets the following conditions:
(1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles.
(2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense.
(3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable.
(4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following:
(i) Acquisition of land;
(ii) Improvement of land, buildings, and equipment; or
(iii) The replacement, modernization, and expansion of buildings and equipment.

Observations:
Based on review of facility documentation and employee interview (EMP) it was determined the facility failed to have an operating budget to maintain an adequate stock of supplies and equipment and failed to take action to address the non-payment issues.
Findings include:

On March 22, 2024, at approximately 2:39 PM, review of Chief Financial Officer (CFO) job description, revealed "... Job Summary: Under the direction of the President, the CFO is responsible for the Hospital's accounting practices, the maintenance of its fiscal records, and the preparation and interpretation of the financial reports for senior management. The CFO plans, organizes, directs, controls and supports the Financial Planning process. Serves as a key member of the Sharon Regional Medical Center (SRMC) Senior Leadership team that sets the hospital's strategic direction as well as financial and organization goals. ... Key Competencies: Annual Budgeting ... develops and oversees the budgeting and financial process. ... Project hospital-wide departmental volume for budget year for review and update with senior leadership. Develop and instruct department heads concerning budget polices, procedures, forms and timetable. Coordinate and run annual budget meetings with department managers. Prepare annual budget report including comprehensive pro forma financial statements. ... Cost Accounting Provides financial analysis to evaluate special projects, capital expenditures and product costing when necessary. ... "

Review on March 22, 2024, of the facility organization chart revealed the CEO/President is the top position at the organization.

1. On March 22, 2024, at approximately 9:30 AM, the facility was requested to provide the annual operating budget. The facility was unable to provide an annual operating budget that included all anticipated income expense, capital expenditures, anticipated sources of financing for each anticipated capital expenditure in excess of $600,000.

2. On March 22, 2024, at approximately 11:18 AM, EMP1 and EMP2 confirmed the facility did not have a Chief Financial Officer at the hospital since November 2023. EMP2 confirmed the governing body at the hospital is non-fiduciary and has no financial authority. The CEO sends requests for funding to the Corporate level and is dependent on Corporate to release funds for the facility




 Plan of Correction - To be completed: 04/23/2024

On March 22, 2024, the hospital provided three (3) years of operating budgets 2022, 2023 & 2024. The budgets included a line item with budgeted supply expense, for example, $22.5M for 2024. The operating budget provided supply expense on a percentage of net revenue which was within expected industry guidelines. The anticipated source of funding for supply expenses is patient and other revenue generated from the hospital with supplemental funding from the corporation as needed.

Sharon Regional's CFO resigned November 17, 2023. The Northeast Regional CFO, assumed the responsibilities on an interim basis the same day. The Northeast Regional CFO prepared the 2024 operating and capital budgets in consultation with the CEO and the Senior Team. Financial
functions continue according to requirements of 482.12(d).

For Q1'24, the hospital is averaging $1.8M of monthly supply expense. The hospital will ensure Par Levels of at least 3 days for supplies required for emergent cases. The hospital will source supplies necessary for elective cases to ensure continuation of elective services without disruption. An FTE has been identified and made a dedicated resource to ensure the compliance to Par Levels for emergent and elective cases effective 04/22/24.

Steward leadership is committed to funding the operational budget to maintain an adequate stock of supplies and equipment, resolve non-payment issues, and maintain an overall institutional plan that meets regulatory requirements.

Monitoring:
Any issues identified at the local level will be immediately communicated to the Corporate Supply Chain leadership team for resolution.
Any issues that cannot be resolved will be communicated to the hospital President for evaluation and recommendations.
Monitoring of all incident reports related to supply issues will be reviewed at Patient Safety Triage Team meetings for corrective action planning/escalation when necessary.

The hospital will maintain a daily supply log of inventory.

In order to ensure the plan of correction demonstrates the organization's commitment to safe patient care, and that we have adequate supply on hand the hospital president has initiated a monitoring program.

Numerator: # days the supplies meet the 3 days' supply

Denominator: # of days per month

The Regional Director of Materials Management will report the audit monthly to the Quality and Patient Safety Committee. The Regional Director of Quality will report the audit monthly to the Medical Executive Committee and Board of Directors.

Responsible Person: Hospital President and Corporate Leadership

482.12(e)(1) STANDARD CONTRACTED SERVICES:Not Assigned
The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

Observations:
Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to ensure contracted services were provided in an effective manner (OTH11).

Findings include:

On March 22, 2024, at approximately 2:26 PM, review of the facility contracts provided revealed that OTH11 provided Environmental Services for the hospital.

A request was made on March 2, 2024, for proof of payment to the Environmental Services contractor. This information was not provided.

On March 22, 2024, at approximately 2:27 PM, review of Quality Improvement data of contract services revealed OTH11 met only 73% of facility cleanliness standards for the first, second, and third quarters for the 2023 calendar. No data was provided for the fourth quarter of 2023.

EMP2 confirmed the above findings at the time of review.




 Plan of Correction - To be completed: 04/25/2024

The hospital President is responsible for all corrective actions and ongoing compliance associated with this element of performance.

Following the survey finding, the hospital President and the Regional Director of Quality reviewed the policy in effect at the time of the survey titled: LD 02: Approval and Monitoring of Contracted Services and found the policy meets current regulatory standards and regulations and required no revisions. The Hospital Board of Directors are ultimately responsible for the monitoring of all contracted services' activities.

The Senior Leadership Team reviewed the EVS Quality Metrics for appropriateness and frequency of review and both were found to be appropriate. If the data required for the quarter is unavailable, the SLT and vendor will determine an alternate method for obtaining data or choose another relevant indicator.

A focused review of the contract for EVS was also conducted. The quarter 4 2023 data was reviewed. The EVS contractor was at 65% patient satisfaction for cleanliness for calendar year 2023 vs a goal of 73%, the EVS contractor had implemented ongoing actions throughout 2023 and into 2024 that include: re-education of their team, creation of cards for the restroom to let the patient know it has been cleaned, one patient per room whenever able, creation of thank you cards and spirit lifters handed to the patients from their team members, attendance at weekly meetings with the hospital President and weekly meetings led by the President with a goal of collaborating with the clinical services team.

Contract metrics are reviewed quarterly at the Quality and Patient Safety Committee and are subject to the same hospital-wide quality assessment and performance improvement evaluation as other services provided directly by the hospital. Any variation from expected compliance should be addressed by the senior leader overseeing the contract with the contracted services local representative and corrective actions developed as indicated.

Immediately following the finding, the Regional Quality Director delegated to the Chair of the Quality and Patient Safety Committee to review existing contracts for compliance to the pre-determined metrics and should such outliers occur the senior leader overseeing the contract will be notified for remediation.

As has been the process, contract metrics will continue to be reviewed at the Quality and Patient Safety Committee quarterly and by the Board of Directors at least annually or more frequently if required.

Regarding payment, the vendor for EVS has confirmed that they received payment from Steward Health on April 5, 2024, for $505,804.00.

The hospital Board of Directors is ultimately responsible for the monitoring of all contracted services' activities.

Under the direction of the hospital President, an ongoing monitoring program was implemented on April 12, 2024.

The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

To ensure the specific deficiencies cited remain corrected and that compliance and regulatory requirements for services is ensured; a monitoring program was developed.

The monitoring program ensures services provided that are safe, effective, and safe for patients. If at any time they are not compliant with quality metrics it will be discussed with the senior leadership team and with the Board of Directors as required.

The program audits a minimum of 4 contracts quality data per month to ensure the contractor is meeting the metrics and if not that there is additional action planning or remediation in place.

Numerator: total number of contracts reviewed that month that are meeting the defined metrics or have an acceptable action plan in place.

Denominator: Total number of contracts reviewed for the month.
Auditing will continue until 100% compliance is achieved for six consecutive months.

Once 100% is achieved for six consecutive months, monitoring will continue on a quarterly basis. If compliance is not 100% at any time additional corrective actions will be implemented based on the reasons for non-compliance and monthly monitoring will be reinstituted.

Monthly the Governing Body receives reports of EVS metrics obtained from patient experience data. When expected compliance is below the set goal, the action plan will be revised to ensure sustainability.

The Regional Director of Quality will report the audit results to the Quality and Patient Safety Committee, and the Board of Directors monthly for the first 6 months and quarterly thereafter. Reporting will begin at the May 2024 meetings.


Responsible Person: Hospital President



482.21(b)(2)(ii), (c)(1), (c)(3) STANDARD QUALITY IMPROVEMENT ACTIVITIES:Not Assigned
(b) Program Data
(2) [The hospital must use the data collected to - .....]
(ii) Identify opportunities for improvement and changes that will lead to improvement.

(c) Program Activities
(1) The hospital must set priorities for its performance improvement activities that--
(i) Focus on high-risk, high-volume, or problem-prone areas;
(ii) Consider the incidence, prevalence, and severity of problems in those areas; and
(iii) Affect health outcomes, patient safety, and quality of care.

(3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.



Observations:

Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to monitor identified cancelled surgical cases due to vendor holds that resulted in the inability to have necessary supplies within the Quality Improvement Plan.

Findings Include:

On March 11, 2024, review of facility policy, LD 07, last revised January 13, 2023, revealed "... Quality and Patient Safety Plan ... 2023-2024 updated December 2022 ... II. [OTH12] ... Accountability: ... Accepting responsibility for continuous performance improvement, embracing change and seeking new opportunities to serve. ... Stewardship: ... Managing our financial and human resources responsibly in caring for those entrusted to us while holding firm our mission and values we seek to create a community-based healthcare system that provided the highest quality care in a financially sound manner ... A. Senior managers and leaders of the organized medical staff work with the Board to define their unique and share responsibilities. The board remains responsible for setting clear expectations for safety; advocating for adequate resources for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients; and enhancing the efficacy and quality of care through an appropriate number of performance improvement initiatives ... B. ... The roles of the MEC [Medical Executive Committee] include (but are not limited to): ... Receiving and acting upon departmental and committee reports concerning patient care issues and other quality management activities; ..."

Review on March 21, 2024, of a surgical cancellation list from September 2023 through March 2024 (a period of six months) related to insufficient supplies revealed 29 of 29 cancelled cases reviewed (MR20-MR48) were identified to be cancelled due to inadequate supplies. Additionally, there were two of two cancelled cardiac cases one for a heart catheterization on September 28, 2023, (MR49) and one for a Percutaneous Coronary Intervention on November 24, 2023, (MR50). The cardiac cases were attempted but unable to be completed due to inadequate supplies.

On March 22, 2024, EMP2 confirmed the facility had not completed any quality/monitoring of identified cancelled cases due to vendor holds that resulted in the inability to obtain supplies.





 Plan of Correction - To be completed: 04/22/2024

Upon receipt of the finding the hospital President immediately notified the Chairperson of the Board. The Board of Directors (BOD) will receive a full report of the findings and corrective action plans at a special meeting on April 8, 2024.

Upon receipt the Corporate Regional President, Steward Chief Medical Officer, Vice President of Quality and Regulatory were notified of the finding.

Following the survey finding, the hospital President and the Regional Director of Quality reviewed the policy in effect at the time of the survey titled: LD 07: Safety Evaluation System and found the policy and associated patient safety plan meets current regulatory standards and regulations and required no revisions.

Data collected is converted to information through assessment and analysis and is used to assess processes and implement improvements and to assure improvements are sustained. This is to include the identification and monitoring of cancelled surgical cases.

Data is presented regularly to Committees and Teams to assess progress towards goals and provided to department and unit directors to share with staff and use in designing improvements.

The Board of Directors (BOD) oversees quality and safety through quarterly (or as necessary) status reports at least quarterly, and the BOD assures that efforts undertaken are effective and appropriately prioritized.

The Senior Leadership Team including the hospital President, Chief Medical Officer, Regional Chief Nursing Officer, Assistant Chief Nursing Officer/Surgical Services Director, and Regional Director of Quality and reviewed the current process of scheduling patients to identify opportunities to proactively manage patient flow and eliminate cancelling surgical cases for reasons within our control eg: limited supply and/or equipment. The prior process for scheduling cases including direct scheduling by the physician offices was halted and a manual process began on April 2, 2024. No cases will be scheduled unless the necessary supply, implant, associated product, and/or equipment is available.

Monitoring:
Beginning on March 29, 2024, the Daily Safety Huddle was augmented to include a report out of cases cancelled and not performed, and the reason for cancellation. If supplies were the etiology of the cancellation, then the President and the Regional Director of Materials Management is notified immediately. In addition, the surgery schedule is printed each day and by the following morning an additional cross check is conducted to assure that any cancelled cases are captured including reason.

The President and Regional Director of Quality reviewed the invitee list for the Quality and Patient Safety Meeting. Beginning with the May 2024 Quality and Patient Safety Meeting, the Regional Director of Materials Management will be invited as an active participant with a focus on quality improvement pertaining to supply issues. In addition, data on cancelled cases related to supply and/or equipment issues will be presented with associated actions if cases were cancelled for said reason. Data will be presented in a run chart as well as table format and action plans will be reviewed and improvement tracked and trended to assure sustainability. The Regional Director of Quality is responsible for the implementation of this plan.

Responsible: Regional Director of Quality

482.21(e)(4) STANDARD PROVIDING ADEQUATE RESOURCES:Not Assigned
[The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:]

(4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients.


Observations:

Based on review of facility documents, medical records (MR) and interview of staff (EMP) it was determined the facility's Governing Body failed to ensure the facility had adequate supplies for surgical procedures for MR20-MR48 to be completed.

Findings Include:

Review on March 22, 2024, of the Governing Body Bylaws, revealed "... Section 2. Duties. Except as otherwise provided in these Bylaws, the Board of Directors shall be responsible for the following: ... (d) Overseeing quality of care at the Corporation, including providing appropriate physical resources and personnel required to meet the needs of the patients and participate in planning to meet the health needs of the patients and health needs of the community ..."

Review on March 21, 2024, of a surgical cancellation list for the previous six months (September 2023 through March 2024) related to insufficient supplies revealed 29 cancelled cases reviewed (MR20-MR48) were identified to be cancelled due to inadequate supplies.

Interview with EMP2, on March 22, 2024, confirmed 29 surgical cases were cancelled due to the inability to obtain necessary supplies.

Cross Reference:
482.12(d) Institutional Budget
482.12(e)(1) Contracted Services



 Plan of Correction - To be completed: 04/23/2024

To remove immediate threat to patients, advanced scheduling has been discontinued and shorter-term scheduling implemented for elective cases. Patients will not be booked for elective procedures without the required supplies and equipment on hand or delivery confirmed.

Upon receipt of the Immediate Jeopardy (IJ) finding, the hospital President immediately notified the Chairperson of the Board. The Board of Directors (BOD) received a report of the findings and corrective action plans at a special meeting April 8, 2024. The President notified the BOD of the findings/documents received 4/10/2024 and 4/12/2024.

Upon receipt the Corporate Regional President, Steward Chief Medical Officer, Vice President of Quality and Regulatory were notified of the IJ finding. In addition, the Senior Leadership Team reviewed the current patient census, services needed, staffing and supplies and determined that safe care can be provided at that time.

A group was immediately convened consisting of the Senior Leadership Team and Corporate Leaders to review and assess surgical services and cardiology services to determine if there were any current supplies that have not been replaced as well as to review the current census, services needed, and staffing.

Departmental Directors / Managers conducted an inventory of supplies and developed a list of items needed to provide services in their department including assuring appropriate par levels.

At the daily huddle effective 3/29/24 and ongoing, all directors/managers are reporting issues related to supplies and equipment. The list of supplies needed to support the services affected is being forwarded to the Sharon Regional Medical Center Senior Leadership team for sourcing of needed supplies. Daily safety huddle report sheet was edited to include assessment and verification of appropriate supply levels for each department, any surgical/procedural cancelations.

In addition, the Chief Medical Officer of Steward Health Care and the system Vice President of Materials Management review the list to source the supplies from the current or alternate vendor.
The equipment and supply vendor lists were categorized by immediately available for delivery from vendor, an alternate vendor, or another facility.

As of 3/29/24 and going forward, OR and procedural cases are reviewed daily to assure that required equipment has been sourced.
All issues with supplies are under continuous monitoring and tracking by procedural department managers and their staff.

Additional communication / education was provided to all staff and providers directing them to report any supply and/or equipment shortage to their manager or Director or via the hospital's online incident reporting system. This will be reinforced during daily shift huddles and leadership rounding and staff must attest in writing to reviewing the communication / education.

An inventory plan is in place and consists of: utilization of the Inventory list of storerooms stocked clinical supplies with current par levels from the supply module in Meditech with perpetual inventory, and items that are not currently stocked were identified. For the following departments: cardiology, radiology, CVU, ICU, Surgical Services, Endoscopy, Pharmacy and Lab, an Inventory list of special order/PO clinical-based items managed locally by department was created and this will be the focus for special order/PO/consignment.

On 3/29/24, the Regional Director of Materials Management and the Senior VP of Corporate Operation reviewed all current purchase orders for supplies necessary to maintain the clinical services cited. Once completed this list was forwarded to The Regional President, Steward Chief Medical Officer, and Corporate Vice President of Materials Management to resolve any ongoing credit issues to assure that adequate supplies are maintained, to effectively carry out the function of the hospital. At the time of booking elective cases, the perioperative team will assess to ensure all supplies needed are available. No elective case will be booked unless the supplies are confirmed to be available.

Beginning on 3/31/2024, the CMO at Sharon Regional Medical Center or his designee (Administrator on Call) will check each morning with the leaders of the Department/Service to ensure that supply inventory has been assessed and is present for the safe care of patients and complete the Supply Grid. Any critical supply not present will be escalated immediately to the President of the hospital, the Regional CFO and the Executive Director of Supply Chain and/or the Senior Vice President of Corporate Operations.

Daily monitoring of supply levels in all departments by department Director/Manager or designee is occurring.

The Daily Safety Huddle report sheet was edited and team members were to include assessment and verification of appropriate supply levels for each department, any surgical/procedural cancelations, inability to accept patients in transfer.

SLT will monitor supply levels daily to assure they can meet the needs of the patients.

Any issues identified at the local level will be immediately communicated to the Corporate Supply Chain leadership team for resolution. Any issues that cannot be resolved will be communicated to the hospital president and regional president for evaluation and recommendations.

All reported concerns regarding supply issues from providers and staff both verbal, and via online incident reporting system will be collated daily by the Regional Director of Quality and communicated to the SLT.

The weekly OR schedule will be monitored by the Inventory Coordinator in collaboration with the Director of Surgical Services to assure the supplies are on hand for upcoming cases and emergent cases. The weekly Cath Lab schedule will be monitored by the Director of Cardiology Services to assure the supplies are on hand for upcoming cases as well as emergent cases.

On a daily basis, the Sharon Vendor Status grid that is maintained by the Direction of Materials Management and the Materials Management team is reviewed. The review is to ensure we have critical supplies available from vendors and alternative sources in the event we are unable to do business with the primary vendor. If it is determined that critical supplies could impact patient safety, it is escalated to the President of the hospital, the Regional CFO and the Executive Director of Supply Chain and/or the Senior Vice President of Corporate Operations.


For Q1'24, the hospital is averaging $1.8M of monthly supply expense. The hospital will ensure Par Levels of at least 3 days for supplies required for emergent cases. The hospital will source supplies necessary for elective cases to ensure continuation of elective services without disruption. An FTE has been identified and made a dedicated resource to ensure the compliance to Par Levels for emergent and elective cases effective 04/22/24.

Steward leadership is committed to funding the operational budget to maintain an adequate stock of supplies and equipment, resolve non-payment issues, and maintain an overall institutional plan that meets regulatory requirements.

Monitoring:
Any issues identified at the local level will be immediately communicated to the Corporate Supply Chain leadership team for resolution. Any issues that cannot be resolved will be communicated to the hospital president and regional president for evaluation and recommendations.
Monitoring of all incident reports related to supply issues, patient care issues/cancellations related to supplies will be reviewed at Patient Safety Triage Team meetings for corrective action planning/escalation when necessary. Reports will be presented to Quality and Safety, Medical Executive Committee and the Board of Directors.

Beginning on 3/31/2024, the CMO at Sharon Regional Medical Center or his designee will check each morning with the leaders of the Department/Service to ensure that supply inventory has been assessed and is present for the safe care of patients and complete the Supply Grid.  Any critical supply not present will be escalated immediately to the President of the hospital, the Regional CFO and the Executive Director of Supply Chain and/or the Senior Vice President of Corporate Operations.

Daily monitoring of supply levels in all departments by department Director/Manager or designee is occurring.

The Daily Safety Huddle report sheet was edited and team members were to include assessment and verification of appropriate supply levels for each department, any surgical/procedural cancelations, inability to accept patients in transfer.

SLT will monitor supply levels daily to assure they can meet the needs of the patients.

Any issues identified at the local level will be immediately communicated to the Corporate Supply Chain leadership team for resolution.  Any issues that cannot be resolved will be communicated to the hospital president and regional president for evaluation and recommendations. 

All reported concerns regarding supply issues from providers and staff both verbal, and via online incident reporting system will be collated daily by the Regional Director of Quality and communicated to the SLT.

The weekly OR schedule will be monitored by the Inventory Coordinator in collaboration with the Director of Surgical Services to assure the supplies are on hand for upcoming cases.

On a daily basis, the Regional Director of Materials Management reviews the Sharon Vendor Status grid that is maintained by her and her team.  The review is to ensure we have critical supplies available from vendors and alternative sources in the event we are unable to do business with the primary vendor.  If it is determined that critical supplies could impact patient safety, she escalates it to the President of the hospital, the Regional CFO and the Executive Director of Supply Chain and/or the Senior Vice President of Corporate Operations.
Any issues identified at the local level will be immediately communicated to the Corporate Supply Chain leadership team for resolution.

Any issues that cannot be resolved will be communicated to the hospital president and regional president for evaluation and recommendations.

Monitoring of all incident reports related to supply issues, patient care issues/cancellations related to supplies will be reported to the hospital President for corrective action planning/escalation when necessary.

Monitoring and Collection of Data:
In order to ensure the specific deficiencies cited remain corrected; the deficiencies do not recur; compliance with this regulatory requirement is maintained; Governing Body oversight is ensured; a monitoring program has been initiated. All procedures (surgical services, cardiac catheterization lab, endoscopy, and interventional radiology) will be monitored on an ongoing basis.

Numerator: total number of procedures by service line each month that were completed without encountering barriers related to needed supply.
Denominator: Total number of procedures scheduled (note: numerator and denominator will exclude incidents that occur whereby the case is cancelled due to a patient centered reason eg: elevated BP, patient decision, etc.)

The Regional Director of Quality will report the results monthly at the following committees: Quality and Patient Safety Committee, Medical Executive Committee and Board of Directors.

Responsible Person: Hospital President





482.41 CONDITION PHYSICAL ENVIRONMENT:Not Assigned
The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community.
Observations:

Based on review of facility documentation, facility tours, and employee interview (EMP), the facility failed to ensure the physical environment of the hospital was safe for patient care. This failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients.

An Immediate Jeopardy was called at 2:16 PM on March 6, 2024, when it was identified the facility was utilizing rooms with non-functioning nurse call bells within rooms 6, 7, and 15 of the Emergency Department. The Immediate Jeopardy was removed at 6:02 PM on March 6, 2024, after the facility submitted and acceptable Immediate Jeopardy removal plan. State Survey Agency verified implementation of an acceptable removal plan when confirmed the facility did a hospital-wide internal audit of all nurse call bell systems. Areas internally identified included the Emergency Department, the Behavioral Health Unit, and 5 West (Med-Surg). Further review of the plan revealed the facility had placed the identified rooms without functioning call bell systems on the Med-Surg and Behavioral Health Unit out of service until the call bells could be fixed. Emergency Department rooms that were identified to have non-functioning call bells were to have staff immediately outside of the rooms for visualization when in use. A tour of the facility revealed the affected Emergency Department rooms utilized at the time of the tour to have staff outside of the room, and rooms on the Med-Surg and the Behavioral Health Unit to be out of service. Confirmation of payment to vendor to obtain necessary supplies was received March 7, 2024. Further ED call bells were functioning effective March 7, 2024.
Additionally, the facility failed to maintain a safe environment by maintaining compliance with the 2012 Edition of the National Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC). Please refer to the FORM CMS-1567 Life Safety Report ZL0421, completed on March 14, 2024.

Cross Reference:
482.41(d)(2) Facilities, Supplies, Equipment, Maintenance







 Plan of Correction - To be completed: 04/25/2024

Following receipt of the immediate jeopardy finding at 2:10 pm on 3/6/24, the hospital President, Chief Nursing Officer (CNO), Senior Director of Specialty Services, Regional Director of Quality, and the Regional Director of Facilities met and reviewed the finding. An immediate assessment of all patient care areas with call lights was conducted by our maintenance technician and our Quality RN and it was determined that there were no additional call lights out of order that the team was unaware of. The team was aware of the call light malfunction in the following rooms and the rooms were not in service: 575, 409, 415, 416, 421, 422, and 423. In order to protect patients and assure patient safety a sitter was placed directly with the patient in ED Room 15. ED Room 7 was taken out of service. Clinically, the patient in room 6 was already a one on one with staff continually present then the room was removed from service once that patient was discharged.

Staff in clinical areas with call lights were educated on the need to take rooms out of service if the call light malfunctions or assign a sitter--defined as a staff member immediately outside of the room for visualization of one or two patients should they need assistance. This was reinforced during daily shift huddles and leadership rounding and staff are attesting in writing to reviewing the communication / education. In addition, this is validated with the leaders at the Daily Safety Huddle.

A Call Light Log was initiated on 3/7/2024 involving an assessment of call light functioning of all clinical areas. Occupied rooms are checked daily, unoccupied rooms will be checked prior to leaving the patient alone the staff will assure the call light is working. If staff find any call lights to be not functioning, the room will be taken out of service or the patient will have a sitter.

All rooms with non-functioning call lights will have a sign posted "Room Out of Order" with the exception of BHU, those rooms will be out of service and locked.

The survey team was provided proof of payment for parts and repair of the system on March 7, 2024. On 3/10/24 675 call light was repaired. On 3/11/24 ED 6, ED7, and ED 15 were repaired.

The current status is that all call lights in the ED are functioning.

The vendor quote has been obtained to replace the system on Adult BHU and the request has been forwarded for processing. The new call light system in Adult BHU is anticipated to be July 2024. The parts for the call lights in Child BHU are on order and the work is anticipated to be completed May 15, 2024. Both units are accommodating patient admissions with the existing rooms in service.

For deficiencies identified by the noncompliance with the 2012 Edition of the National Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC). Please refer to the FORM CMS-2567 Life Safety Report ZL0421, completed on March 14, 2024 were submitted 4/17/2024 for review under separate cover and included E001, E036, E041, K100, K133, K161, K251, K271, K291, K293, K324, K345, K353, K355, K372, K374, K531, K761, K908, K911, K912, K918, K920.

Monitoring:
In order to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community, and to ensure the plan of correction is effective and the deficiencies remain corrected and that compliance with regulatory requirements for a safe environment safe for patient care is maintained a monitoring program was developed under the direction of the hospital President. The program was implemented April 1, 2024.

Under the direction of the hospital President, an ongoing monitoring program was implemented on April 12, 2024 to both ensure the POC is effective and that equipment is maintained and to ensure an acceptable level of safety and quality care is provided.

Audit 1:
Open work orders will be reviewed by the Regional Safety Officer on a weekly basis and the Regional Safety Officer will escalate any concerns regarding open work orders to the appropriate Senior Leadership Team Member.
Numerator: The total # of priority 1 work orders completed each month
Denominator: The total # of priority 1 work orders submitted for each month.
Auditing will continue until 100% compliance is achieved for six consecutive months. Once 100% compliance is achieved for six consecutive months, monitoring will continue on a quarterly basis. If compliance is not 100% at any time additional corrective actions will be implemented based on the reasons for the non-compliance and monthly monitoring will be reinstituted.
The Regional Safety Officer will report the work order audit results to the Quality and Patient Safety Committee and the Environment of Care Committee monthly. The Regional Director of Quality will report at least quarterly to the Board of Directors. Reporting will begin at the May 2024 meetings.

Audit 1:
Numerator: the number of functioning call lights

Denominator: the total number of patient call lights

The Regional Director of Quality/designee will report the call light audit results to the Quality and Patient Safety Committee and to the Board of Directors monthly beginning at the May 2024 meetings.

Audit 2:
Numerator: # in the denominator that has documentation/evidence that the room was removed from service, or an observer was assigned

Denominator:
# of rooms with non-functioning call lights

Auditing will continue until 100% compliance is achieved for six consecutive months. Once 100% compliance is achieved for six consecutive months, monitoring will continue on a quarterly basis. If compliance is not 100% at any time additional corrective actions will be implemented based on the reasons for the non-compliance and monthly monitoring will be reinstituted.

The Director of Quality will report the audit results to the Quality and Patient Safety Committee and the Board of Directors monthly for the first six months and quarterly thereafter. Reporting will begin at the May 2024 meetings.

Responsible Person: Hospital President




482.41(d)(2) STANDARD FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE:Not Assigned
Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.
Observations:

Based on review of facility documentation, facility tours, and employee interview (EMP), the facility failed to ensure nurse call bells were functional in all Emergency Department rooms.

An Immediate Jeopardy was called at 2:16 PM on March 6, 2024, when it was identified the facility was utilizing rooms with non-functioning nurse call bell systems within rooms 6, 7, and 15 of the Emergency Department. The Immediate Jeopardy was removed at 6:02 PM on March 6, 2024, after the facility submitted and implemented an acceptable Immediate Jeopardy removal plan. State Survey Agency verified implementation of an acceptable removal plan when confirmed the facility did a hospital-wide internal audit of all nurse call bell systems.

On March 7, 2024, review of facility policy, Environment of Care, EOC 09, dated August 9, 2023 revealed "... Procedure A. The Facilities/Plant Operations Department provides a system in which an emergency or urgent situation, can be addressed in a prompt and efficient manner. The goal is to maintain a safe environment for patients, visitor, and employees. ... B. Utilities equipment is categorized into groups of high-risk utility components that supports: (1) Life Support, (2) Infection Control, (3) Non-Life Support but essential for patient care and (4) All other utilities equipment. 1. Any work order received that affects Life Support or Infection Control will take priority over all other work. This work must be undertaken and corrected at a planned completion rate of 100% with no exceptions. This work will be overseen by the Facilities/Plant Operations Director/designee, who will determine when the work is accomplished to the customers' needs. 2. Work that is Non-Life Support but essential for patient care will take the next priority. 3. All other work will be prioritized based on first in first out, staff availability, part availability, or cost. ..."

On March 6, 2024, review of open work order log revealed call bell systems within the Emergency Department was on the log for maintenance, effective February 4, 2024.

On March 6, 2024, tour of the ED confirmed Exam Rooms 6, 7, and 15 did not have functioning nurse call bells.

On March 6, 2024, review of a facility audit identified non-functioning nurse call bells in the Behavioral Health Unit and on the 5 West Medical Surgical Unit.

On March 6, 2024, employee interview with EMP8 revealed that parts for call bells within the Emergency Department were on order for approximately three months. Further confirmed that the rooms within the Emergency Department had non-functioning call bells.

On March 6, 2024, employee interviews with EMP9 and EMP10 confirmed call bells within Exam Rooms 6 and 7 of the Emergency Department were not consistently functioning.

Cross reference:
482.41 Condition of Participation: Physical Environment







 Plan of Correction - To be completed: 04/25/2024

The hospital President is responsible for all corrective actions and ongoing compliance associated with this element of performance.
Following the survey finding, the hospital President, Regional Director of Quality, and the Senior Director of Specialty Services, and the Regional Safety Officer reviewed the policy in effect at the time of the survey titled: EOC 09: Vytal Work Order Process found the policy meets current regulatory standards and regulations and required no revisions.

The Senior Leadership Team reviewed the work order process and determined there was an opportunity to assure all staff understand their responsibility to enter work orders and to assure patient safety issues are addressed and mitigated. All staff are responsible for submitting work orders and incident reports.

As identified at the time of the survey, the work order had been placed for out of service call lights and at the time, the work had not been completed. To maintain a safe environment for patients the Facilities department has established a standardized method of classifying and processing work requests.
Work orders are reviewed at the Environment of Care (EOC) Committee. Work orders are prioritized according to category by facilities. The Facilities Director determined the involved staff have completed the initial Vytal Training Guide Work Order Management in February of 2023 and continues to comply with education on periodic system upgrades. All priority one work orders that are open and pending are reported to the Regional Facilities Director and if needed are escalated to the Senior Director of Specialty Services and the Senior Leadership Team. Open priority one work orders are also reported the EOC Committee.

Following receipt of the immediate jeopardy finding at 2:10 pm on 3/6/24, the hospital President, Chief Nursing Officer (CNO), Senior Director of Specialty Services, Regional Director of Quality, and the Regional Director of Facilities met and reviewed the finding. An immediate assessment of all patient care areas with call lights was conducted by our maintenance technician and our Quality RN and it was determined that there were no additional call lights out of order that the team was unaware of. The team was aware of the call light malfunction in the following rooms and the rooms were not in service: 575, 409, 415, 416, 421, 422, and 423. In order to protect patients and assure patient safety an observer was placed with the patient in ED Room 15 and ED Room 7 was taken out of service. Clinically, the patient in room 6 was already a one on one with staff continually present and the room was removed from service once that patient was discharged.

All current staff in clinical areas with call lights were educated on the plan to take rooms out of service or assign an observer-- defined as a staff member immediately outside of one room or two adjacent rooms for direct visualization should they need assistance if the call light is not functioning. Attestations of receipt and understanding of education are being signed. This education will continue shift to shift until all clinical staff have been educated.

A Call Light Log will be done and the functioning of call lights in occupied rooms will be checked daily, prior to placing new patients in a room and prior to leaving the patient alone the staff will assure the call light is working. If staff find any call lights to be not functioning, the room will be taken out of service or the patient will have an observer.

All rooms with non-functioning call lights will have a sign posted "Room Out of Order" with the exception of the Behavioral Health Units (BHU), those rooms will be out of service and locked including rooms 409 (Adult BHU), 415, 416, 421, 422, and 423 (Child BHU). The vendor quote has been obtained to replace the system on Adult BHU and the request has been forwarded for processing. The new call light system in Adult (BHU) is anticipated to be July 2024. The parts for the call lights in Child BHU are on order and the work is anticipated to be completed May 15, 2024. Both units are accommodating patient admissions with the existing rooms in service.

The current status is that all call lights in the ED are functioning.

Monitoring:
Under the direction of the hospital President, an ongoing monitoring program was implemented on April 12, 2024 to both ensure the POC is effective and that equipment is maintained and to ensure an acceptable level of safety and quality care is provided.

Audit 1:
Open work orders will be reviewed by the Regional Safety Officer on a weekly basis and the Regional Safety Officer will escalate any concerns regarding open work orders to the appropriate Senior Leadership Team Member.
Numerator: The total # of priority 1 work orders completed each month
Denominator: The total # of priority 1 work orders submitted for each month.
Auditing will continue until 100% compliance is achieved for six consecutive months. Once 100% compliance is achieved for six consecutive months, monitoring will continue on a quarterly basis. If compliance is not 100% at any time additional corrective actions will be implemented based on reasons for the non-compliance and monthly monitoring will be reinstituted.
The Regional Safety Officer will report the work order audit results to the Quality and Patient Safety Committee and the Environment of Care Committee monthly. The Regional Director of Quality will report at least quarterly to the Board of Directors. Reporting will begin at the May 2024 meetings.

Audit 2:
Numerator: the number of functioning call lights
Denominator: the total number of patient call lights
The Regional Director of Quality/designee will report the call light audit results to the Quality and Patient Safety Committee and to the Board of Directors monthly beginning at the May 2024 meetings.

Audit 3:
Numerator: # in the denominator that has documentation/evidence that the room was removed from service, or an observer was assigned
Denominator:
# of rooms with non-functioning call lights
Auditing will continue until 100% compliance is achieved for six consecutive months. Once 100% compliance is achieved for six consecutive months, monitoring will continue on a quarterly basis. If compliance is not 100% at any time additional corrective actions will be implemented based on reasons for the non-compliance and monthly monitoring will be reinstituted.

The Director of Quality will report the audit results to the Quality and Patient Safety Committee and the Board of Directors monthly for the first six months and quarterly thereafter. Reporting will begin at the May 2024 meetings.

Responsible Person: Hospital President


482.42 CONDITION INFECTION PREVENTION CONTROL ABX STEWARDSHIP:Not Assigned
The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program.
Observations:

Based on review of facility documentation, a facility tour, and employee interview (EMP), it was determined that the facility failed to maintain equipment for the cleaning and sterilization of surgical and procedural materials in accordance with accepted standards with manufacturer's recommendations and failed to maintain a sanitary environment. These failures resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients.

An Immediate Jeopardy was called on March 7, 2024, at approximately 3:50 PM, an Immediate Jeopardy (IJ) was identified for the CoP for Infection Control. On March 12, 2024, at approximately 4:39 PM, the facility was unable to maintain surgical equipment when they were unable to provide documentation that washer # 1 washer # 2 were cleaned according to Manufacturer Guidelines. On March 13, 2024, at approximately 11:15 AM, the facility was unable to provide documentation of cleaning of the Sterilizer as required per Manufacturer Guidelines. On March 14, 2024, at approximately 2:15 PM, the facility was unable to provide documentation of required maintenance for two of two endoscopy reprocessors.
On March 15, 2024, at approximately 5:24 PM Immediate Jeopardy was removed after the facility provided an acceptable IJ Removal Plan. SA verified implementation of acceptable removal plan when a tour of the Surgical Services Department revealed that the facility took action to enforce a sanitary environment within the Department. Additional actions included the immediate delegation of responsible party to ensure cleaning and maintenance of washer # 1, washer # 2, and the sterilizer. Applicable staff attested to re-education of sterilization processes and maintenance for sanitary environment. The facility temporary ceased Endoscopy Services until maintenance of endoscopy reprocessors was able to be completed, which was completed for one of two endoscopy reprocessors on March 18, 2024.

Cross Reference:
482(a)(3) Infection Control Surveillance, Prevention (A 750)






 Plan of Correction - To be completed: 03/15/2024

(Washers)
Following receipt of the washer finding at 3:15pm on 3/7/24 the washers were immediately removed from service and "Out of Service" signage was placed. All Sterile Processing Department (SPD) staff were notified that the washers are out of service until further notice.
The manufacturer's instructions for use (IFU) on the washers were reviewed by the team and a log was developed for the completion of weekly cleaning and descaling. The log includes identification of washer by # 1 and #2, the manufacturers steps for cleaning and descaling, date, time and signature of person completing. All staff (RNs, scrub techs, and SPD staff) were re-educated on the manufacturers,' IFU on the washers and completed an observation competency for the cleaning of the washers prior to performing independently and signed an attestation of understanding.

To ensure a sanitary environment is maintained:

A surgical services team member will complete cleaning prior to utilizing the washer each day the OR is open for procedures; this will be documented on a log.

(Sterilizers)
Following receipt of the sterilizer finding at 11:15 on 3/13/24 the sterilizer was immediately removed from service and "Out of Service" signage was placed. All SPD staff were notified that the sterilizers were out of service until further notice.

The manufacturer's instructions for use (IFU) on the sterilizers were reviewed by the team and a log was developed for the completion of daily cleaning and maintenance. The log includes the manufacturers steps for cleaning and maintenance, date, time, and signature of person completing. All staff (RNs, scrub techs, and SPD staff) were re-educated on the manufacturers' IFU on the sterilizers and completed an observation competency for performing cleaning and maintenance of the sterilizers prior to performing independently and signed an attestation of understanding.

To ensure a sanitary environment is maintained:

A surgical services team member will complete cleaning and maintenance prior to utilizing the sterilizer each day the OR is open for procedures; this will be documented on a log.

(Endoscopic Re-Processors)
Following receipt of the endoscopic re-processor finding at 2:15pm on 3/14/24 the re-processor was removed from service and "Out of Service" signage was placed. All endoscopic staff were notified the re-processors were out of service. The vendor performed preventative maintenance (PM) on 3/18/24 and was placed back in service following the PM.

The Corporate Chief Medical Officer and President North Region, North Region COO, and Vice President Quality and Regulatory were notified to assure patient safety. Sharon Regional Medical Center Senior Leadership team and Surgical Services Director met on an ongoing basis to review all findings.

Retrospective review of the cleaning logs ensured that the Olympus re-processors were operating correctly for each load ensuring high level disinfection.

However, because of the expired PM, the hospital canceled future cases until the PM could be completed. The hospital notified EMS, emergency department, the medical staff, the surgical staff, and the nursing supervisor. Endoscopic procedures resumed on 3/15/24.

Retrospective review of surgical instrument washer and sterilizer records show: (1) proper operation for Washers #1 and #2 for each day of surgical services, and (2) proper sterilization for surgical instruments (Bowie Dick, chemical and biological indicators).

To ensure a sanitary environment is maintained:

An endoscopy team member will check the preventative maintenance light on the endoscopic re-processor each day the endoscopy area is open for procedures and will cease processing if the light is flashing (indicating a preventative maintenance is needed) and notify the appropriate clinical engineer. The daily check of the PM light will be documented on a log.

Monitoring:
In order to assure the maintenance of a sanitary environment we have an active house-wide program for the surveillance, prevention, and control of hospital acquired infections (HAIs)and other infectious diseases that adheres to nationally recognized infection prevention and control guidelines. Cleaning and maintenance of the washers, sterilizers, and endoscopic re-processors is an important component of this program.

To ensure that a sanitary environment is maintained, a monitoring program was developed.

Washers Monitoring:
Effective 4/1/2024 the ACNO/designee is auditing the cleaning logs for the instrument washers.
Numerator: the number in the denominator compliant with evidence of cleaning documented on the logs
Denominator: the number of days surgery is open for procedures


Sterilizers Monitoring:
Effective 4/1/2024 the ACNO/designee is auditing the cleaning & maintenance logs for the sterilizers
Numerator: the number in the denominator compliant with evidence of cleaning & maintenance documented on the logs
Denominator: the number of days surgery is open for procedures


Endoscopic Re-processor Monitoring:
Effective 4/1/2024 the ACNO/designee is auditing to assure the PM light is assessed each day while the endoscopy area is open for procedures.
Numerator: the number in the denominator compliant with evidence the documentation has been completed.
Denominator: the number of days endoscopic services is open for procedures

For all 3 audits, auditing will continue until 100% compliance is achieved for six consecutive months. Once 100% is achieved for six consecutive months, monitoring will continue on a quarterly basis. If compliance is not 100% at any time additional corrective actions will be implemented based on reasons for the non-compliance and monthly monitoring will be reinstituted.

The ACNO is responsible for the oversight of all auditing and will report the audit results to the Quality and Patient Safety Meeting, the Infection Control Meeting, and the Board of Directors monthly for the first 6 months and quarterly thereafter. Reporting will begin at the May 2024 meetings.

Responsible Person: Chief Nursing Officer











482.42(a)(3) STANDARD INFECTION CONTROL SURVEILLANCE, PREVENTION:Not Assigned
The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and
Observations:

Based on review of facility documentation, a facility tour, and employee interview (EMP), it was determined that the facility failed to maintain equipment for the cleaning and sterilization of surgical and procedural materials in accordance with accepted standards of practice and manufacturer's recommendations and failed to maintain a sanitary environment.

Findings include:

On March 25, 2024, review of the facility's "2023 Infection Prevention and Control Annual Assessment and Plan," revised 1/13/2023, revealed " ... Strategies Environmental: Rounds ... Description The Infection Preventionist participates in environmental rounds with facility team members to assess patient safety and environmental safety, and quality. Plan ... Participate in environmental rounds with facility team members. Provide education on a case-by-case basis to staff, patients and visitors as identified. ... Sterilizer testing is done in accordance with AORN, AAMI and CDC recommendations. ... Sterilizer report fall-outs or issues will be submitted to the Infection Prevention Control Committee by the Director of Surgery. ... Accurate logs will be completed and reviewed by the Infection Prevention and Control. ..."

On March 8, 2024, review of the Operator Manual for Washer # 2, dated 3/31/2008, revealed " ...Alteration of equipment which could adversely affect its operation ... Routine Maintenance ... Daily Cleaning ... After last cycle of day, allow unit to cool. Then, remove and clean debris screens in bottom of wash chamber and suction filter at the bottom sump. Always clean screens while they are still wet, before foreign matters dries ... 2. Remove rise valve and inspect for debris. Brush and rinse under tap water if necessary. Monthly Cleaning ... On a weekly basis, perform the following routine procedures; 1. Clean washer exterior as follows: ... a. Using a damp cloth or sponge, apply cleaner in a back-and forth motion, rubbing in same direction as surface grain b. Thoroughly wipe off cleaner. C. Polish surface with a clean, dry, lint-free cloth. 2. Wash chamber interior with a moderately alkaline detergent solution. Rinse with tap water and dry with a lint-free cloth ... Monthly Cleaning ... Remove hard water deposits from chamber and loading accessories as follows, using DESCALER cycle especially designed for this purpose. ... "
On March 11, 2024, review of the facility policy IC 50, " Sterilization Processes, " last reviewed June 23, 2022, revealed, " ... 6. All sterilizers are used according to manufacturer's written instructions. ... 12. Responsibilities with regards to sterilization processes: a. SPD manager is responsible for direct oversight of sterilization processes throughout the hospital. ... b. Infection Control has the overall responsibility to ensure that there is an effective program for cleaning, disinfection, and sterilization of reusable medical and surgical supplies. ... "
On March 11, 2024, review of the Operators Manual for the Sterilizer, dated 4/6/2016, revealed " ... In addition to the weekly flushing ...steam generator requires quarterly cleaning and yearly descaling (minimum recommended frequency). Have a qualified service person perform these procedures. ... "
On March 14, 2024, review of the Operators Manual for Washer #1, dated 3/31/2008, revealed " ... Routine Maintenance 6.2 Daily Cleaning ... Weekly Cleaning ... "
On March 14, 2024, review of Operators Manual for the endoscope reprocessor, dated 1/11/2012, revealed " ... After use, reprocess and store this equipment referring to the instructions ...End-of-day-checks in this manual. Inappropriate care and storage could present an infection control risk and/or cause equipment damage and malfunction. ... If any irregularity is observed, do not use the equipment ... If the lamp of the PERIODICAL MAINTENANCE indicator described in Section 2.5, Control Panels on page 24 blinks, contact [Manufacturer]. ... "
A policy for maintaining a clean and sanitary environment was requested on March 6, 2024. This policy was not provided prior to exit of survey.
1. On March 7, 2024, a tour of the sterile processing clean room revealed a visible accumulation of green and brown debris on the inside of window of washer # 2, an accumulation of matter on the outside of washer # 2, visible accumulation of thick dust above washer # 2.

EMP3 confirmed the above finding at the time of the tour.

On March 13, 2024, the facility was unable to provide documentation that daily maintenance and cleaning had been performed on washer # 1.

EMP2 further confirmed documentation was not available on March 13, 2024.

On March 13, 2024, surgical staff at the facility were unable to identify the processes for daily cleaning and maintenance for washer # 1, and washer # 2, according to manufacturer's guidelines.

2. On March 14, 2024, a tour of the endoscopy suite revealed the lamp of the periodical maintenance indicators had been blinking on two of two endoscopic reprocessors. Further observation revealed the endoscopic reprocessors were in use at the time of tour. Staff were unable to provide documentation of manufacturer service as required per manufacturer guidelines.

EMP7 confirmed finding occurred due to vendor holds.

3. On March 6, 2024, Intensive Care Unit (ICU) tour revealed room 450 to be observed to have an overflowing waste receptacle and a cracked outlet cover near the head of the bed. EMP3 confirmed the room was cleaned prior to the observation. Additional observations of the ICU revealed chipped paint throughout the walls and door frames throughout the unit and discoloration of ceiling tiles.

EMP3 confirmed findings at the time of the tour. EMP3 further confirmed that discoloration of ceiling times was from prior ceiling leak. Timeframe of leak was unable to be identified.
Above findings in the ICU were not included on the open work order list provided prior to tour of the ICU.

4. On March 6, 2024, a tour of the Medical Imaging Department revealed the following findings:

Ultrasound room 2 observed to have chipped paint on the walls, countertops, and cabinetry, exposing surface integrity. Attached room was observed to have a cracked pipe under the sink.

MRI hallway observed to have substantial discoloration of ceiling tiles. Ceiling tile discoloration in the Medical Imaging Department was identified to be included on the open work list provided, effective December 20, 2023. Remaining findings above were not included on the list provided prior to tour of the Department.

Dressing rooms observed to have visible accumulated debris on walls.

X-Ray Room 2 and 4 observed to have chipped cabinetry, exposing the surface integrity.

CT Room observed to have chipped paint, exposing surface integrity, and discoloration of wall.

EMP11 confirmed wall discoloration was from prior leak from the Maintenance Department that was located directly above the area. Unable to identify timeframe.

Changing area restroom observed to have discolored ceiling tiles and holes within the tiles.

EMP3 confirmed above findings at the time of the tour.

On March 13, 2024, EMP12 confirmed the facility had difficulties obtaining necessary cleaning supplies for the Medical Imaging Department due to vendor holds.

Above findings in the Medical Imaging Department were not included on the open work order list provided prior to tour of the Department.

5. On March 6, 2024, a tour of the Emergency Department revealed the following findings:
Decontamination area attached to Emergency Department room 1 revealed chipped shower tiles, and cracked ceiling tiles.

Emergency Department room 6 revealed multiple chipped areas exposing wood on the surface of the overbed wall-unit, dark grey speckling of a mold-like substance on the ceiling tile above the wall mounted cabinetry, and a food-substance on the window of the sliding door.

EMP3 confirmed room 6 was cleaned prior to observation.

Emergency Department rooms 7, 16, and 18, revealed scuffed paint, and chipped areas on the surface of the head wall unit.

Above findings in the ED were not included on the open work order list provided prior to tour of the Department.

6. On March 6, 2024, a tour of the Dietary Department revealed multiple areas non-intact flooring. There was exposed and burrowing cement. The floor surfaces were uneven with large areas of indentations, exposing the cement beneath. Additionally, an accumulation of debris was observed behind the ice machine, and an air handler unit pipe was duct taped together. EMP13 confirmed duct taped pipe was due to prior leak. Unable to identify timeframe of the leak.

EMP3 confirmed above findings at the time of the tour.

Above findings in Dietary were not included on the open work order list provided prior to tour of the Dietary.

7. On March 7, 2024, a tour of the Surgical Services Department revealed the following:

The sterile processing dirty room revealed the surface of the sink and surrounding cabinetry to contain a large amount of rust.

A sub-sterile area located at the end of the hallway had an actively leaking sink, with a green film inside the bowl of that sink that extended up the faucet. Visible water damage and mold-like substance identified under the sink cabinetry.

Main operating room corridor was identified to have discoloration of approximately twelve ceiling tiles. EMP3 confirmed discoloration was due to prior roof leak that occurred approximately one week prior to the observation. Further confirmed that the roof leaks when it rains.

Operating Rooms 5 and 6 were identified as being cleaned. Both rooms were observed to have debris and a build-up of unknown substance on the floor.

EMP3 confirmed above findings at time of the tour.

Above findings in the Surgical Services Department were not included on the open work order list provided prior to tour of the Department.

8. On March 7, 2024, tour of the Physical Therapy Department revealed approximately six overhead lights to be non-functional. Further observation revealed discolored ceiling tiles above the linen carts and active medical gas outlet, a cut ceiling tile surrounding a sprinkler, observation of a tube to be protruding from the ceiling tiles leading into a waste receptacle. The surrounding approximate three feet of ceiling tiles and floor space was discolored. Ceiling discoloration extended into the adjacent storage room, which contained an electrical panel.

EMP3 confirmed above findings at time of the tour.

Above findings were not included on the open work order list provided prior to tour of the Department.

9. On March 7, 2024, tour of the Laboratory revealed the following findings.

Observation of exposed wiring in the ceiling, discolored ceiling tiles, and approximately nine missing light bulbs.

EMP14 confirmed light bulbs were removed from the light fixtures approximately one year ago.

Observation of the central processing room of the lab revealed two over head lights to be nonfunctioning and approximately three discolored ceiling tiles, counter tops to be cracked, exposing surface integrity, a cracked receptacle outlet, an approximate three-foot high shelf that was previously dislodged from the wall exposing a hole in the wall. The identified shelf was propped up with use of a biohazard waste receptacle.

Observation of the chemistry area and microbiology area revealed approximately sixteen non-functioning lights, an uncapped exposed pipe on the lab wall, a non-functioning pneumatic tube system, and various cracked and peeling floor tiles. EMP14 confirmed the pneumatic tube system had not been working for approximately one week prior. Further confirmed delay in fixing was related to vendor holds.

Observation of the specimen collection area revealed a ceiling tile with a hose protruding into a waste receptacle adjacent to an electrical panel box, and specimen collection refrigerator. Bottom shelf of the specimen refrigerator was observed to contain debris and a build-up of brown matter.

10. On March 7, 2024, a tour of Cath Lab 2 revealed approximately four batteries sitting on top an electrical box, exposed wiring from a missing wall mounted digital clock, a thermostat loosely secured to the wall, and an accumulation dust within the recessed lighting.
Additional observation revealed uneven floor surfaces directly outside the room.

11. On March 7, 2024, a tour of 4 West and 6 West (Med-Surg) revealed observation of wide-spread nonfunctioning overhead lighting throughout.

12. On March 11, 2024, review of an internal environment checklist, completed by EMP6 on January 23, 2024, revealed identified concerns within the Emergency Department. No actions taken upon internally identifying concerns. Further confirmed no actions were taken as a result of internally identified concerns during employee interview with EMP6 on March 22, 2024.

13. On March 11, 2024, review of internal environment checklists, completed by EMP6 on February 27, 2024, revealed infection control concerns identified within the Surgical Services Department. No actions taken upon internally identifying concerns. Further confirmed no actions were taken because of internally identified concerns during employee interview with
EMP6 on March 22, 2024.

On March 22, 2024, EMP6 confirmed all elements of the facility's Infection Control Plan were not enforced.






 Plan of Correction - To be completed: 04/22/2024

The hospital President is responsible for all corrective actions and ongoing compliance associated with this element of performance.

Following the survey finding, the hospital President, Regional Chief Nursing Officer (CNO), Infection Control Preventionist, Director of Environmental Services (EVS), Director of Surgical Services, and the Regional Director of Quality reviewed the policy in effect at the time of the survey titled: IC 17 Environmental Services and determined the policy meets current regulatory standards and regulations and determined the policy required no revisions. In addition, the Infection Control Plan was reviewed and was found to be comprehensive and up to date. Education was developed on IC 17 and all staff were educated on IC 17 and environmental cleanliness with an emphasis on patient care equipment. In addition, education was provided to clarify what the clinical staff is responsible for vs what the EVS staff is responsible for. Staff on leave will be educated upon return to work.

In addition, the President, Regional Facilities Director, Senior Director of Specialty Operations, Biomed Site Lead, reviewed the policies in effect at the time of survey titled: BCE 03 Equipment Testing and BCE 04 Equipment Problems, Failures, User Errors. Both policies were found to meet current regulatory standards and regulations and required no revisions. In addition, the Equipment Management Program and Plan was reviewed by the Regional Safety Officer and required no additions or corrections. Education was developed on BCE 03 and BCE 04 for all staff with an emphasis on key concepts including adherence to manufacturer's instructions (MIFU) for use, tips for interpreting clinical engineering/biomed tags, and triggers for notification of biomed for equipment. Staff on leave will be educated upon return to work.

Following the survey finding, the President, Regional Facilities Director, Senior Director of Specialty Operations, Administrative Assistant Plan Operations, Regional Safety Officer, and Regional Director of Quality met and reviewed EOC 09: Work Order Process. The policy was found to meet current regulatory standards and regulations and required no revisions. Education was developed on EOC 09 for all staff with an emphasis on how to enter a work order and key examples of critical types of work orders pertaining to clinical safety. Staff on leave will be educated upon return to work.

1. Washer #2 was immediately removed from service with signage placed, all staff informed, and Bio Med was notified. EVS was contacted immediately to remove the visible dust noted above the washer. In addition, cleaning of visible buildup on the outside of washer 2 was completed on 3/7/24. On 3/8/2024 the door was removed and the debris was removed from between the glass. The washer remained out of service pending re-certification which was conducted on 3/12/24. The manufacturer's instructions for use (IFU) were reviewed, a log was developed for the completion of weekly cleaning and descaling. The log includes identification of washer by # 1 and #2, the manufacturers steps for cleaning and descaling, date, time and signature of person completing. All staff were re-educated on the manufacturers IFU. All staff (RNs, Scrub Techs, and SPD) scheduled 3/13/24 and 3/14/24 completed an observation competency performing cleaning and descaling, prior to performing independently. All staff have signed an attestation of understanding.

2. Following receipt of the endoscopic re-processor finding at 2:15pm on 3/14/24 the re-processor was removed from service and "Out of Service" signage was placed. All endoscopic staff were notified the re-processors were out of service. The vendor performed preventative maintenance (PM) on 3/18/24 and was placed back in service following the PM.

The Corporate Chief Medical Officer and President North Region, North Region COO, and Vice President Quality and Regulatory were notified to assure patient safety. Sharon Regional Medical Center Senior Leadership team and Surgical Services Director met on an ongoing basis to review all findings.

Due to the expired PM, the hospital canceled future cases until the PM could be completed. The hospital notified EMS, emergency department, the medical staff, the surgical staff, and the nursing supervisor. Endoscopic procedures resumed on 3/15/24.

Retrospective review of the processing logs ensured that the re-processors were operating correctly for each load ensuring high level disinfection.

3. The waste that was overflowing from the trash receptible was removed immediately during the survey on 3/6/2024. The outlet cover was repaired on 3/6/2024. The anticipated completion date for painting the walls and door frames is 4/19/24. The discolored ceiling tiles were replaced on 3/9/2024.


4. US room 2 walls were painted on 3/11/2024, counters were repaired on 3/11/2024, cabinets were repaired on 3/10/2024, cracked water pipe was repaired on 3/21/24, MRI hallway and radiology ceiling tiles are anticipated to be completed on 4/20/2024. Dressing rooms were cleaned on 3/6/2024, cabinets in XR rooms 2 & 4 were repaired on 3/11/2024, CT room chipped paint anticipated to be corrected by 4/19/24, Discoloration on wall was cleaned by Environmental Services on 3/11/24. and again on 4/16/24 The changing area restroom ceiling tiles were replaced on 3/9/24.

Confirmed on 3/7/2024 that radiology team has the cleaning supplies that they need and confirmed with both the leadership of radiology and the materials management leadership that we ae not experiencing issues obtaining cleaning supplies.

5. A temporary silicone barrier was used to assure the surface is non-porous chipped tiles in the Decontamination room. It is anticipated that a permanent resolution will be in place by 5/30/24. The damaged ceiling tiles were replaced on 3/15/24, ED room 6 wood on the wall unit as well as the painting and repair of chipped areas in ED Rooms 7, 16, and 18 will be accomplished by 4/20/24. The glass door was cleaned on 3/6/2024.

6. Vendor contacted and quote obtained for the flooring and the anticipated date of completion is anticipated to be 6/10/24 subject to vendor and material availability, debris behind ice machine was cleaned on 3/6/2024, the tape on the air handler pipe was removed and the pipe was repaired with armor flex pipe insulation on 3/7/2024.


7. Rust was removed from the SPD sink on 3/8/24, rust removed from the cabinets and cabinets repainted on 3/8/2024, sub-sterile sink was taken out of service on 3/7/24, signage placed, sink and faucet was replaced on 3/8/24, water damage remediated and cabinet thoroughly cleaned on 3/8/24. Ceiling tiles were replaced on 3/9/2024. The facilities director had already had a vendor on site on 2/21/2024 to evaluate the roof and repairs had been completed on 3/1/2024. The debris on the OR floors was removed on 3/7/24 immediately, on the evenings of 3/7/2024 and 3/8/2024 all OR floors were scrubbed and burnished and all ORs underwent a thorough terminal cleaning. There is a process for weekly terminal cleaning by Environmental Services.

8. The overhead lighting issues were corrected on 3/30/2024, ceiling tiles were replaced on 3/11/2024, the tube and receptacle were deemed not necessary and were removed on 3/7/2024, the floor discoloration was remediated on 3/11/24, on 3/7/2024 the facilities electrician was dispatched to assess the electrical panel in the storage room and determined that the electric panel was not impacted by moisture.

9. The exposed wiring determined to be phone wire was corrected on 3/10/2024, the work to replaced discolored ceiling tiles commended on 3/18/2024 and was completed on 3/28/2024, lighting issues and bulb replacements were completed on 3/9/2024 and 3/10/2024, the cracked and exposed countertops were repaired on 4/15/24, the cracked outlet plate was replaced on 3/21/2024, dislodged shelf was removed and hole in wall was repaired on 3/10/24 and the unused biohazard container was disposed of, a cap for the drain line was installed on 3/8/2024, the pneumatic tube system was repaired and fully functioning on 4/2/2024, the hose and waste receptacle were removed on 3.7.2024 and the panel was an IT junction box and refrigerator were both assessed, neither incurred damage, the specimen refrigerator shelf was cleaned immediately on 3/7/24.

10. The batteries were removed from the box immediately on 3/7/2024, the wiring was checked by the electrician and was not electrical in nature, wall clock was replaced on 3/7/2024, the dust was removed immediately on 3/7/2024, a vendor was on site on 3/15/2024 to assess the flooring outside the entrance and the anticipated repair date is anticipated to be 6/10/24 subject to vendor and material availability.

11. Assessment of all lighting in the facility began on 3/7/2024 and all lights were repaired and/or new bulbs placed on 3/10/2024.

12. The Environment of Care (EOC) tours checklist was reviewed with the Safety Officer/EOC Committee Chair. The EOC rounding process had recently been revised and the EOC chairperson has defined the responsibilities of the participants and has created a process to assure mitigation of internally identified issues. To assure compliance is sustained with loop closure, the Safety Officer will do a retrospective review of all EOC checklists monthly and assure the issues are under review and/or remediated. Results of this will be reported monthly at the EOC Committee and the Quality and Patient Safety Committee and quarterly to the Board of Directors.

13. The EOC rounding process had recently been revised and the EOC chairperson has defined the responsibilities of the participants and has created a process to assure loop closure on internally identified issues. To assure compliance is sustained, the Safety Officer will do a retrospective review of all EOC checklists monthly and ensure the issues are under review and/or remediated. Results of this will be reported monthly to the EOC Committee and the Quality and Patient Safety Committee and quarterly to the Board of Directors.

Monitoring:
For findings 1-11: An audit program was implemented to monitor the environment for issues related to infection prevention and control that the existing Open for Business rounding tool was edited to include findings 1-11. Compliance will be reported monthly to the Quality and Patient Safety Committee monthly, Infection Control monthly, and Board of Directors quarterly.

Responsible: Chief Nursing Officer

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