HospitalInspections.org

Based on review of facility policy and procedures, review of personnel files (PF), review of medical records (MR) and interviews with staff (EMP), it was determined the facility failed to provide care in a safe setting by not ensuring an employee who provided services to patients in 11 of 11 medical records reviewed had an active status license required for their position in one of 15 personnel files reviewed (PF1), (MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, and MR14)

Findings include:

Review on November 21, 2019, of facility policy "Verification of License," reviewed August 16, 2019, revealed, "The purpose of this policy is to ensure that all organization employees posses [sic] the license, certification or registration at the time of hire and maintains the license, certification or registration during their term of employment that is required of their position. In addition, the policy established that the Human Resources Department is responsible for initially verifying validity and ensuring the annual confirmation that the licensure, certification or registration of these employees remains valid in accordance with regulatory agencies that govern licensure and certification ... The annual confirmation will be performed by the employee's Home Department with results reported to Human Resources in written form for a placement in the personnel file ... Employees are responsible for maintaining valid licensure, certification or registration and providing that information to their department."

Review on November 21, 2019, of PF1 revealed their current licensure verification from The Department of State contained the following, " ... Status Effective Date: 8/2/2019 ... Last Renewal: 8/2/2019 ... Expiration date: 12/31/2020." Review of the previous licensure period revealed the Department of State license verification for PF1 had an expiration date of "12/31/2018".

Review on November 22, 2019, of MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, and MR14 revealed these patients were admitted to the facility and had a procedure performed between January 2, 2019, and June 26, 2019. Further review of the "Intraop Record" and/or the "Cardiopulmonary Bypass Record" for MR4 through MR14 confirmed the employee in PF1 provided services for each of these patients during the time the license for their position was not valid.

Interview with EMP5 on November 21, 2019, at 2:30 PM confirmed the employee in PF1 was employed in their position at the facility from the expiration of the previous license dated December 31, 2018, through the renewal date of August 2, 2019, for the current license, and the facility failed to ensure the verification of the license for PF1. Further interview with EMP5 confirmed the facility also failed to have a process in place for license verifications during this time frame.

Interview with EMP2 on November 22, 2019, at 10:30 AM confirmed the employee PF1 provided services to the patients MR4 through MR14 between January 2, 2019, and June 26, 2019, during the time their license for their position was expired.

Based on review of medical records (MR), review of facility documents and interviews with staff (EMP), it was determined that the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program as evidence by: failing to show measurable improvement in quality indicators and ensuring that they were measured, analyzed and tracked to determine the effectiveness and safety of services provided by the hospital for 5 of 5 service lines reviewed: Endocrinology,Gastroenterology, Immunology, Neurology, and Pulmonology(A0273); failing to evaluate performance improvement interventions for success and are not tracked to ensure that improvements are sustained (A0283); failing to report within the required time frame the occurrence of pressure injury events for 14 of 14 records (MR30-MR44) reviewed and by not completing the focused review process for selected adverse events (A0286); failing to conduct distinct improvement projects proportional to the scope and complexity of the hospital's services and operations. Also, failing to document the measurable progress achieved on selected projects (A0297); failing to ensure Quality Assessment and Performance Improvement (QAPI) monitoring was performed for all services provided under contract with an outside company and services provided under arrangement (A308); failing to establish hospital wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. Also, failing to ensure the determination of the number of distinct improvement projects is conducted annually (A309); failing to ensure that adequate resources are allocated for measuring, assessing, improving and sustaining the hospital's performance and reducing risk to patients and failing to have enough staff to implement Patient Safety Plan (A0315).


Cross Reference:
482.21(a),(b)(1),(b)(2)(i),(b)(3)- Data Collection & Analysis
482.21(b)(2)(ii), 482.21(c)(1) & 482.21 (c)(3) 482.21(b)(2) - Quality Improvement Activities
482.21(a),(c)(2),(e)(3)-Patient Safety
482.21(d) - Performance Improvement Projects
482.21 - Quality Assessment & Performance Program
482.21(e) - Executive Responsibilities
482.21(e) (4) - Providing Adequate Resources

Based on a review of facility documents and interviews with staff (EMP), it was determined that the facility failed to establish an ongoing Quality Assessment Performance Improvement (QAPI) program that showed measurable improvement in quality indicators and failed to show evidence that indicators were measured, analyzed and tracked to determine the effectiveness and safety of services provided by the hospital for five of five service lines reviewed (Endocrinology,Gastroenterology, Immunology, Neurology, and Pulmonology).

Findings include:
Review of the facility's Quality Assurance and Performance Improvement Plan 2019, revealed, " ... IV. ... The organizational leaders perform the following functions: ... adopt an approach to performance improvement, set exceptions and priorities for Organization-wide performance improvement that are designed to improve safe patient care delivery, outcomes and customer satisfaction ... ensure that important processes and activities are measured, assessed and improved systematically throughout the organization ... V. ... The process for identifying priorities focus areas for improvement requires input and discussion with senior leadership, departments, and services from all areas involved with quality performance measurement and improvement ... VI. ... Team members representative of all involved services collaboratively develop indicators and quality performance measurement specifications based on the opportunities identified for focus ... ."

A request was made on November 21, 2019, at 11:00 AM, to EMP1 for quality indicators and performance improvement activities related to the following hospital service lines: Endocrinology,Gastroenterology, Immunology, Neurology, and Pulmonology. None provided.

A request was made on November 21, 2019, at 11:00 AM, to EMP1 for documented evidence of ongoing data collection related to indicators for above service lines and that the data received was measured, analyzed, and tracked. None was provided.

Interview on November 21, 2019, at approximately 2:00 PM, with EMP1 revealed that the the following hospital service lines: Endocrinology,Gastroenterology, Immunology, Neurology, and Pulmonology were not a part of the hospital-wide quality program. Further confirmed no documented evidence of ongoing data collection related to indicators for above service lines and that the data received was measured, analyzed, and tracked.

Based on a review of facility documents and interviews with staff (EMP), it was determined that the facility failed to use data collected to identify opportunities for improvement hospital wide and changes that will lead to improvement; failed to evaluate the success of performance improvement interventions and track performance to ensure that improvements are sustained.

Findings include:
Review of the facility's Quality Assurance and Performance Improvement Plan 2019, revealed, " ... IV. ... The organizational leaders perform the following functions: ... adopt an approach to performance improvement, set exceptions and priorities for Organization-wide performance improvement that are designed to improve safe patient care delivery, outcomes and customer satisfaction ... ensure that important processes and activities are measured, assessed and improved systematically throughout the organization ... V. ... The process for identifying priorities focus areas for improvement requires input and discussion with senior leadership, departments, and services from all areas involved with quality performance measurement and improvement ... VI. ... Team members representative of all involved services collaboratively develop indicators and quality performance measurement specifications based on the opportunities identified for focus ... ."
A request was made on November 21, 2019 to EMP1 for facility dashboard reflecting hospital wide quality indicators. Provided "Comprehensive Cardiac Care Measures" and "Department of Pediatrics Clinical Quality Report."

Review on November 21, 2019 of facility's, "Comprehensive Cardiac Care Measures," no date, revealed "Metric/Measure" ... Cardiothoracic Surgery Complications ... ."

Review on November 21, 2019 of facility's, " Department of Pediatrics Clinical Quality Report," dated July 25, 2019, revealed, " Metrics ... Rapid Responses resulting in Unsafe transfers ... ."

A request was made on November 21, 2019 for documented evidence that interventions implemented for quality indicators (Cardiothoracic Surgery Complications and Rapid Responses resulting in Unsafe transfers) were evaluated for success. None provided.

Interview on November 21, 2019, at approximately 2:00 PM, with EMP1 confirmed no documented evidence that interventions implemented for quality indicators (Cardiothoracic Surgery Complications and Rapid Responses resulting in Unsafe transfers) were evaluated for success. Further confirmed data collected for implemented performance improvement interventions are not evaluated for success and are not tracked to ensure that improvements are sustained. Further confirmed facility does not have a hospital wide dashboard inclusive of all quality indicators followed by facility.

Based on review of facility documents and staff interviews (EMP), facility failed to establish an ongoing program that shows measurable improvement in indicators for which there is evidence that it will identify and reduce medical errors, failed to measure, analyze and track adverse patient events as evidenced by not reporting within the required time frame the occurrence of pressure injury events for 8 of 8 records (MR30-MR38) reviewed and by not completing the focused review process for selected adverse events.

Findings include:
Review on November 21, 2019 of facility's "Patient Safety Plan," dated November 26, 2018 revealed, " ... V. Reporting Requirements: 1. All adverse events, sentinel events and near misses shall be reported by staff using the electronic based reporting system ... 2. ... The report shall be made immediately or as soon as thereafter as reasonable practicable, but in no event later than 24 hours after the occurrence or discovery of a serious event or incident ... ."
Review on November 21, 2019 of facility's "Serious/Sentinel Event Reporting," revealed " ... Process Flow for Sentinel and Serious Events ... Risk Management in collaboration with DCQI and PSO determine if a Root Cause Analysis or Focused Review is needed ... ."
Review on November 21, 2019 of facility's "Adverse Event Log," dated November 2018 thru November 2019 revealed multiple events.
Request was made on November 21, 2019 to EMP1 and EMP2 for a list of adverse events determined to need a focused review. None provided.

Request was made on November 21, 2019 for completed focused reviews for any event on Adverse Event Log. None provided.

Review on November 21, 2019, of Pressure Injury event log dated November 6, 2018 thru October 8, 2019, revealed patients related to MR30 thru MR38 had a pressure injury event occur. Further revealed these pressure injury events were reported in the electronic based reporting system over 24 hours after it occurred or was discovered.

Review on November 21, 2019, of Serious Event Log revealed pressure injury events related to MR30 thru MR38 were not documented.

Interview on November 21, 2019 with EMP1 at approximately 2:00 PM confirmed there were adverse events determined to need a focused review completed. Further confirmed the focused reviews were not completed and events determined to require a focused review were not being logged. Further confirmed patients related to MR30 thru MR38 had a pressure injury event occur. Further confirmed these pressure injury events were reported in the electronic based reporting system over 24 hours after it occurred or was discovered.

Interview on November 22, 2019 with EMP2 at approximately 1:30 PM confirmed Pressure Injuries are considered serious events.

Based on review of facility documents and interview with staff (EMP), facility failed to conduct distinct improvement projects proportional to the scope and complexity of the hospital's services and operations and failed to document the measurable progress achieved on selected projects.

Findings include:

Review of the facility's Quality Assurance and Performance Improvement Plan 2019, revealed, " ... IV. ... The organizational leaders perform the following functions: ... adopt an approach to performance improvement, set exceptions and priorities for Organization-wide performance improvement that are designed to improve safe patient care delivery, outcomes and customer satisfaction ... ensure that important processes and activities are measured, assessed and improved systematically throughout the organization ... V. ... The process for identifying priorities focus areas for improvement requires input and discussion with senior leadership, departments, and services from all areas involved with quality performance measurement and improvement ... VI. ... Team members representative of all involved services collaboratively develop indicators and quality performance measurement specifications based on the opportunities identified for focus ... ."

Review on November 21, 2019 of facility's monthly, "Quality Committee Minutes," dated January 2019 thru September 2019 revealed no documented evidence of discussions related to facility's performance improvement projects.


Review on November 21, 2019 of facility's "2019 Performance Improvement Projects," revealed the following projects: Metric Based Weight Recommendations, Lift Device, ED POC Urinalysis Documentation, DART Injury Rate, CLASBI K-Card, Hand Hygiene Program, Pressure Injury, and Unplanned Extubations. Further review revealed no documentation of the measurable progress achieved on the projects. The review also revealed the projects were not proportional to the scope and complexity of the hospital's services and operations.

Requested on November 21, 2019 of EMP1 documented evidence that performance improvement projects were reviewed and approved by Governing Body. None provided.

Interview on November 21, 2019 at approximately 2:00 PM confirmed no documented evidence of QI Committee discussions of performance improvement projects. The interview also confirmed no documentation of the measurable progress achieved on the projects and confirmed Governing Body had not reviewed and approved the list of projects.

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to ensure Quality Assessment and Performance Improvement (QAPI) monitoring was performed for all services provided under contract with an outside company and services provided under arrangement.

Findings include:

Review on November 20, 2019, of the facility's "Quality Assurance and Performance Improvement Plan 2019," revealed "... The organizational leaders perform the following functions: ... Monitor the performance and quality of contracted services ... ."

Request was made on November 20, 2019 to EMP1 for a list of facility's contracted services and provided was "Vendor Entity."

Review on November 21, 2019 of "Vendor Entity," revealed a list of approximately 100 vendors or outside companies that provided services under arrangement.

Interview with EMP1 on November 20, 2 019, at approximately 9:45 AM confirmed the facility's Performance Improvement Program does not contain documentation for monitoring all services provided under contract with an outside company and services provided under arrangement.

Based on review of facility policy, documents and interview with staff (EMP), it was determined the facility failed to establish hospital wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated and failed to ensure the determination of the number of distinct improvement projects is conducted annually.

Findings include:

Review on November 21, 2019, of the facility's Quality Assurance and Performance Improvement Plan 2019, revealed, " ... IV. ... The organizational leaders perform the following functions: ... adopt an approach to performance improvement, set exceptions and priorities for Organization-wide performance improvement that are designed to improve safe patient care delivery, outcomes and customer satisfaction ... ensure that important processes and activities are measured, assessed and improved systematically throughout the organization ... V. ... The process for identifying priorities focus areas for improvement requires input and discussion with senior leadership, departments, and services from all areas involved with quality performance measurement and improvement ... VI. ... Team members representative of all involved services collaboratively develop indicators and quality performance measurement specifications based on the opportunities identified for focus ... ."
Review on November 21, 2019 of facility's "Serious/Sentinel Event Reporting," revealed " ... Process Flow for Sentinel and Serious Events ... Risk Management in collaboration with DCQI and PSO determine if a Root Cause Analysis or Focused Review is needed ... ."

Review of Adverse Event log dated November 2018 thru November 2019 revealed multiple events related to hospital wide wrong MD orders and/or medication errors.

Request was made on November 21, 2019 to EMP1 and EMP2 for a list of adverse events determined to need a focused review. None provided.

Request was made on November 21, 2019 for completed focused reviews for any event on the facility's Adverse Event Log. None provided.

Review on November 21, 2019 of facility's monthly, "Quality Committee Minutes," dated January 2019 thru September 2019 revealed no documented evidence of discussions related to facility's performance improvement projects.

Request was made on November 21, 2019 for documented evidence of Performance Improvements activities related to hospital wide wrong MD orders and/or medication errors. None provided.

Request was made on November 21, 2019 for a list of facility's Performance Improvement Projects. Provided "2019 Performance Improvement Projects."

Review on November 21, 2019 of "2019 Performance Improvement Projects," revealed no project related to wrong MD orders and/or medication errors. Further revealed no evidence of governing body review or approval of listed projects.

A request was made on November 21, 2019 to EMP1 for facility dashboard reflecting hospital wide quality indicators. Provided "Comprehensive Cardiac Care Measures" and "Department of Pediatrics Clinical Quality Report."

Review on November 21, 2019 of facility's, "Comprehensive Cardiac Care Measures," no date, revealed "Metric/Measure" ... Cardiothoracic Surgery Complications ... ."

Review on November 21, 2019 of facility's, " Department of Pediatrics Clinical Quality Report," dated July 25, 2019, revealed, " Metrics ... Rapid Responses resulting in Unsafe transfers ... ."

A request was made on November 21, 2019 for documented evidence that interventions implemented for quality indicators (Cardiothoracic Surgery Complications and Rapid Responses resulting in Unsafe transfers) were evaluated for success. None provided.

Review on November 22, 2019, of facility's "Board Report Matrix: 2019," revealed Quality/Patient Services reports to the Governing Body occur biannually in March and September.

Review on November 22, 2019, of facility's "Board of Governors," dated "March 26, 2019" and "September 24, 2019," revealed no documented evidence of review or approval related to facility's performance improvement projects.

Interview on November 21, 2019, at approximately 2:00 PM, with EMP1 confirmed no documented evidence that interventions implemented for quality indicators (Cardiothoracic Surgery Complications and Rapid Responses resulting in Unsafe transfers) were evaluated for success. Further confirmed data collected for implemented performance improvement interventions are not evaluated for success and are not tracked to ensure that improvements are sustained. Further confirmed the "2019 Performance Improvement Project," still needed to be reviewed and approved by the Governing Body. Further confirmed facility's "Quality Assurance and Performance Improvement Plan 2019" was not reviewed and approved by the Governing Body. Further confirmed no documented evidence of a QAPI dashboard/metrics reflecting hospital wide quality indicators. Further confirmed there were adverse events determined to need a focused review completed. Further confirmed the focused reviews were not completed and events determined to require a focused review were not being logged.

Based on review of facility documents and interviews with staff (EMP), it was determined that the facility failed to ensure that adequate resources are allocated for measuring, assessing, improving and sustaining the hospital's performance and reducing risk to patients.

Findings include:

Review on November 20, 2019, of facility's policy, "Quality Assurance and Performance Improvement Plan 2019," revealed " ... The organizational leaders perform the following functions: ... Allocate adequate resources, including personnel, time and data collection systems for assessment and improvement of the Organization's governance, managerial, clinical and support processes ... ."

Request was made on November 20, 2019 to EMP1 for the facility's QAPI budget. None Provided.

Interview on November 20, 2019 at 9:45 AM with EMP1 confirmed the facility failed to ensure that adequate resources are allocated for measuring, assessing, improving and sustaining the hospital's performance and reducing risk to patients. Further confirmed there is no documented evidence of allocation of resources towards the QAPI program.


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Based on review facility documents and staff interview (EMP), it was determined the facility failed to provide personnel necessary to implement the facility's Patient Safety Plan.

Findings include:

Review on November 22, 2019, of facility document dated August 23, 2019, to November 22, 2019, revealed 184 patient safety occurances were not reviewed, categorized or reported to the Pennsylvania Patient Safety Authority within the prescribed time frame as outlined by the Authority.

Interview on November 22, 2019, at 11:00 AM with EMP3 confirmed they are responsible for the reviewing the facility's internal safety occurrences and reporting the occurrences that meet PA-PSRS reportable event criteria. Continued interview with EMP3 confirmed they are the only person in their department responsible for reviewing, categorizing, investigating and reporting safety occurrences to the PA-Patient Safety Authority.

Interview on November 22, 2019, at 1:20 PM with EMP1 confirmed they were not aware of ACT 13 or the Pennsylvania Patient Safety reporting requirements. Further interview with EMP1 confirmed the facility was in bankruptcy and there were "not enough funds," and were allocating funds that were a "priority to provide a reasonable standard of care."