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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 (A0273); and failing to adequately analyze the cause of patient deaths after Cardiothoracic surgery, failing to analyze the cause of an adverse event and failing to analyze the cause of a medication event (A0286).


Cross Reference:
482.21(a),(b)(1),(b)(2)(i),(b)(3)- Data Collection & Analysis
482.21(a),(c)(2),(e)(3)-Patient Safety

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 these indicators were measured, analyzed and tracked to determine the effectiveness and safety of services provide by the hospital for three of three quality indicators reviewed (Cardiothoracic Surgery, Medication Events and Pharmacy).

Findings include:
Review of the facility's "2015 Quality and Patient Safety Improvement Plan," approved by the "Quality Improvement Committee" February 4, 2015, revealed " The SCHC [St. Christopher's Hospital for Children] Quality and Patient Safety Improvement Plan is a description of the organizational, multidisciplinary and systematic quality and safety improvement functions designed to support the Mission, Vision and Values of St. Christopher's Hospital for Children. The purpose of the Quality and Patient Safety Improvement Plan is to identify the organization's systematic approach to improving and sustaining high quality performance through the prioritization, design, implementation, monitoring, and analysis of improvement initiatives. ... Measuring and Monitoring Quality: Quality and Patient Safety Improvement initiatives must be objective and data driven. Integration of a structured approach to improvement is guided by the following: ... - Initiatives and proposed measures are developed with multidisciplinary team input (including trainee participation) -Inventory of best practices, evidence-based guidelines and collaboration with other children's hospitals is preferred ... -Risk and event-related data is used to guide improvement activities when available ... -Track and trend data over time ... -Evaluate proposed interventions in terms of ease of implementation and reliability of intervention. -Data collection is systematic and is used to: a) Establish a performance baseline; b) Describe process performance or stability; c) Describe the dimension of performance relevant to functions, processes, and outcomes; d) Identify areas for more focused data collection to sustain improvement. ..."

A request was made on March 16, 2016, at 11:00 AM, to EMP1 for quality indicators and performance improvement activities related to the Cardiothoracic Surgery Department. EMP1 provided facility document, "Quality Improvement in Cardiac Surgery Data Collection," that revealed "2014 review of data identified inconsistencies in Cardiac Surgery procedures entered on the OR log and procedures entered in STS database. ..."

A request was made on March 17, 2016, at 10:30 AM, to EMP1 for evidence of ongoing data collection related to this indicator and that the data received was measured, analyzed, and tracked. None was provided.

Review of the "2015 Quality and Patient Safety Improvement Plan" did not identify any indicators or performance improvement activities related to the Cardiothoracic Surgery Department.

Interview on March 18, 2016, at 2:20 PM, with EMP8 revealed that the Cardiothoracic Surgery Department quality indicator was not a part of the hospital-wide quality program and confirmed that the Cardiothoracic surgery Department "does there own thing with quality."

2. Review on March 17, 2016, of facility document "Medication Events Quality Indicator" revealed medication event data is to be collected daily and reported monthly in the medication incident reporting database. Further review of the database revealed that data was not collected or reported for the months of October, November and December 2015.

Interview on March 18, 2016, at 1:00 PM, with EMP2 confirmed that medication event data was not collected, reported or analyzed for the fourth quarter of 2015.

3. A request was made on March 18, 2016, 10:30 AM, to EMP1 for quality indicators and performance improvement activities related to Pharmacy Services. EMP3 revealed that the Pharmacy Department was working on a quality indicator for the completeness and accuracy of physicians orders for children under 40 kgs.

A request was made on March 18, 2016, at 11:45 AM, to EMP6 for evidence of ongoing data collection related to this indicator and that the data received was measured, analyzed, and tracked. None was provided.

Interview with EMP3 confirmed that pharmacy failed to establish a standardized written method of collecting, analyzing and tracking data for this indicator.

Review of the "2015 Quality and Patient Safety Improvement Plan" did not identify any indicators or performance improvement activities related to the Cardiothoracic Surgery Department.

Interview on March 18, 2016, at 11:30 AM, with EMP1 confirmed that the Pharmacy Services quality indicator was not a part of the hospital-wide QAPI plan and that the facility was not collecting, tracking and analyzing data related to this indicator.

Based on review medical records (MR), review of facility documents and interviews with staff (EMP), it was determined that the facility failed to adequately analyze the cause of patient deaths after Cardiothoracic procedures for eight of eight Cardiothoracic surgery medical records reviewed (MR1, MR2, MR3, MR5, MR8, MR9, MR10, MR13), failed to adequately analyze the cause of an adverse event for one patient (MR19), and failed to adequately analyze the cause of a medication event for one patient (MR21).

Findings include:

1. Review on March 16, 2016, of facility's "2015 Quality and Patient Safety Improvement Plan," approved by the "Quality Improvement Committee" on February 4, 2015, revealed " ... 2015 Quality and Patient Safety Improvement Plan St. Christopher's Hospital for Children (SCHC) is committed to improving the safety and quality of care and services for the patients and communities it serves. ... Assignment Of Responsibility: ... Quality Improvement Committee Role in Quality and Patient Safety: The Quality Improvement committee is made up of hospital and medical staff representation and is responsible for maintaining the quality vision of the organization. The committee has the responsibility to ensure a strategic and structured approach to continous quality improvement. The medical staff committee chair and medical staff members of the committee are appointed by the president of the medical staff. ... Specific functions of the Quality Improvement Committee include: ... -Critically analyze reports received, recommend actions and ensure follow up until satisfactory conclusion is achieved. ... "

A request was made on March 17, 2016, for facility bylaws for the Mortality and Morbidity Committee. None were provided.

Review on March 16, 2016, of MR1 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR1's case was reviewed and referred to another hospital department, Intensive Care Unit and Cardiology, for further review. A request was made on March 16, 2016, for documentation regarding the outcome of the review that was to be completed by the Intensive Care Unit and Cardiology department. None was provided.

Review on March 16, 2016, of MR2 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR2's case was reviewed and referred to another hospital department, Intensive Care Unit and Cardiology, for further case review. A request was made on March 16, 2016, for documentation regarding the outcome of the review that was to be completed by the Intensive Care Unit and Cardiology department. None was provided.

Review on March 17, 2016, of MR3 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR3's case was reviewed and referred to another hospital department, Cardiology, for further case review. A request was made on March 17, 2016, for documentation regarding the outcome of the review that was to be completed by the Cardiology department. None was provided.

Review on March 17, 2016, of MR5 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR5's case was reviewed and referred to another hospital department, Cardiology, for further case review. A request was made on March 17, 2016, for documentation regarding the outcome of the review that was to be completed by the Cardiology department. None was provided.

Review on March 17, 2016, of MR8 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR8's case was reviewed and referred to another hospital department, Intensivist Service, for further case review. A request was made on March 17, 2016, for documentation regarding the outcome of the review that was to be completed by the Intensivist Service. None was provided.

Review on March 17, 2016, of MR9 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR9's case was reviewed and referred to another hospital department, Cardiology, for further case review. A request was made on March 17, 2016, for documentation regarding the outcome of the review that was to be completed by the Cardiology department. None was provided.

Review on March 17, 2016, of MR10 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR10's case was reviewed and referred to another hospital department, Cardiology and Intensivist Service, for further case review. A request was made on March 17, 2016, for documentation regarding the outcome of the review that was to be completed by the Cardiology department and Intensivist Service. None was provided.

Review on March 17, 2016, of MR13 revealed this patient expired after a Cardiothoracic procedure at the facility. Review of facility documents revealed MR13's case was reviewed and referred to another hospital department, Critical Care, for further case review. A request was made on March 17, 2016, for documentation regarding the outcome of the review that was to be completed by the Critical Care department. None was provided.

Interview on March 16, 2016, at 2:30 PM, with EMP1 confirmed there were no bylaws that described the facility's Mortality and Morbidity Committee.

Interview on March 18, 2016, at 10:30 AM, with EMP8 confirmed there was no documentation regarding the outcome of the review for the cases that were referred to other departments for additional review.

2. Review on March 18, 2016 of facility document, "2015 Quality and Patient Safety Improvement Plan," approved by the "Quality Improvement Committee" on February 4, 2015, revealed "... Measuring and Monitoring Quality: -An intense analysis of undesirable patterns or trends in quality including, but not limited to the following criteria: ... (d) Serious adverse drug reaction or medication event or risk thereof ... - A Root Cause Analysis will be performed for all sentinel events to identify the base or contributing causal factors that underlie variations in performance. An RCA may also be completed for any process variation for which recurrence would carry a significant chance of adverse event. ..."
Review of MR19 revealed that the patient was transferred to the hospital on January 10, 2012 for "further studies."
Review of MR19 "ECMO Flowsheet," dated March 24, 2012, by EMP7 revealed that the ECMO pump sounded, displaying an error code, after EMP7 placed platelets (a component of blood) on the ECMO pump. The nurse began to manually "handcrank" the machine which showed "massive amounts of air observed in arterial and venous cannulas."
Interview on March 17, 2016, at 11:30AM, with EMP9, indicated that the facility conducted a Root Cause Analysis (RCA) of the event. EMP9 was asked what did the facility determine to be the cause of the event. EMP9 revealed that "they still aren't sure if it was related to EMP7 returning from being on maternity leave for 3 months or a machine malfunction." EMP9 would only show documentation regarding the interventions that were implemented after the event occurred. There was no documented evidence provided to show that this event was critically analyzed to determine the root cause, including how air got into the machine, or other contributing factors, in order to prevent recurrence.

3. Review on March 18, 2016 of facility document, "2015 Quality and Patient Safety Improvement Plan," approved by the "Quality Improvement Committee" on February 4, 2015, revealed "... Measuring and Monitoring Quality: -An intense analysis of undesirable patterns or trends in quality including, but not limited to the following criteria: ... (d) Serious adverse drug reaction or medication event or risk thereof ... - A Root Cause Analysis will be performed for all sentinel events to identify the base or contributing causal factors that underlie variations in performance. An RCA may also be completed for any process variation for which recurrence would carry a significant chance of adverse event. ... Appendix A: Quality/Patient Safety Priority Focus Areas and Target Metrics ... Quality and Safety Improvement Priority Focus Area #2: Improve Safe Delivery of Medications -Medication Errors (category C and above) ..."

Review on March 18, 2016, of MR21 revealed this patient had a confirmed drug to drug interaction that was reported as a category D medication event on April 6, 2015. Review of facility documents revealed MR21's case was reviewed and a root cause analysis performed.

Requests were made on March 18, 2016, at 10:15 AM, to EMP1 for the analysis that was performed, for the medication event that the patient experienced, in order to determine if the events were being reported and investigated; and to evaluate whether data regarding reports of such events and incidents were being tracked and analyzed by the facility, to ensure that they were being used to improve health outcomes. None was provided.

Interview on March 18, 2016, at 10:25 AM, with EMP5 confirmed the review data for the medication event could not be located.

Interview on March 18, 2016, at 10:40 AM, with EMP1 confirmed that they could not find the follow-up regarding the adverse medication event for MR21.