The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SOUTHWESTERN REGIONAL MEDICAL CENTER, INC 10109 EAST 79TH STREET TULSA, OK 74133 Aug. 30, 2012
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on review of hospital documents, job descriptions, policy and procedure, Governing Board Minutes, Medical Staff Meeting Minutes, Quality Assurance Plans for 2011 and 2012, and interviews with staff, it was determined the hospital facility failed to ensure the CEO and the Governing Body had adequate oversight of the Quality Assurance and Performance Improvement program.

Findings:

1. On August 30, 2012 surveyors reviewed the Quality Assurance Performance Improvement (QAPI) plans for 2011 and 2012. The plan(s) both stipulate the facility will report data on the following: Key performance indicators, operative or other procedures that place patients at risk of disability or death; all significant discrepancies between preoperative and postoperative diagnoses, including pathologic diagnoses; adverse events related to using moderate or deep sedation or anesthesia, the use of blood and blood components and all confirmed transfusion reactions; the results of code blue resuscitation and early response through rapid response team calls; significant mediation errors; significant adverse drug reactions; patient and stakeholder perception of the safety and quality of care and treatment, and services; contracted care, treatment and services.

The plans were not modified based on ongoing analysis of patient safety data. The plans further stipulate, "...annually the Executive leadership, Medical Staff leadership, Lean Six Sigma Operations and the Quality Department will assess the performance improvement accomplishments, areas needing improvement, fulfillment of regulatory and accreditation standards, and applicability to our mission will be evaluated. These results will be used in part to establish the next year's plan..."

2. QAPI plans for 2011 and 2012 were identical. There were no changes based on problems identified through risk or surveillance.

3. There was no documentation in Governing Body Meeting Minutes or Medical Staff Meeting Minutes the plans had been reviewed and approved through governance. The plans did not have a date of approval or implementation. There was no documentation in the meeting minutes the governance followed the plan and annually evaluated the indicators to be used to establish the following year's plan.

4. On 8/30/12 surveyors reviewed Governing Body Bylaws. There was no stipulation in the bylaws or policies or the quality assurance plan the Governing Body was responsible for the quality and safety of patients through an ongoing program of quality improvement.

5. On 8/30/2012 surveyors reviewed the job description of the Chief Executive Officer (CEO) There was no stipulation the CEO is accountable for the effectiveness of the QAPI program. There are no meeting minutes (Governing Body, Medical Staff, Cancer Committee, or CLIC) stipulating the CEO is accountable for the program. The Governing Body Bylaws do not stipulate the CEO is accountable for the effectiveness of the QAPI program.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on record review and staff interview, it was determined the hospital failed to ensure the QA/PI program included all programs and services, including contract services. Findings:

The Performance Improvement and Patient Safety Plan for FY 2012 documented, "... Scope of Services... The scope of our services is oncology and includes adult inpatient care, ambulatory care, distance support care and general medical surgical care..."

The hospital provided a list of contracted services that included supplemental nursing staff, a personal trainer and sleep study services.

The performance improvement plan did not include provisions for QA/PI indicators for each department within each service line. The plan did not address QA/PI for contracted services.

Of those key performance indicators documented elsewhere, very few impacted high risk, high volume or problem prone areas. No key performance indicator documentation provided to the surveyors included medical error indicators.

The only documentation of a patient safety performance indicator provided to the surveyors involved patient falls.

On 08/30/12, staff B was asked if the QA/PI program should focus on medical errors and adverse events. She stated it should.

Staff B was asked to provide documentation of QA/PI activities related to contract services. No documentation was provided.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on record review and staff interview, it was determined the hospital QA/PI plan failed to document how it would identify and reduce medical errors. Findings:

The Performance Improvement and Patient Safety Plan for FY 2012 documented, "... The organization has ongoing, proactive process for identifying and reducing unanticipated adverse events and patient safety risks to patients through the use of an electronic variance reporting system and at least one high risk process is analyzed through the use of a Failure Mode Effect Analysis a minimum of every 18 months..."

There was no other documentation in the plan that indicated what other methods could be used to gather data on medical errors and adverse events that may not have been reported electronically.

On 08/30/12, staff C was asked if medical errors and adverse events were tracked with any other method other than the electronic variance program. She stated she would look into that.

2. On 8/30/2012, surveyors reviewed Governing Body Meeting Minutes 2011-2012, Medical Staff Meeting Minutes 2011-2012, Cancer Committee Meeting Minutes 2012 (identified as the Quality Assurance Committee by Staff B), Leadership (CLIC) Committee 2011-2012 (also identified as the QA committee. There was no information the facility utilized information from peer review processes, incident/occurrence reporting, patient care data, environmental surveillance, interviews or other methods to monitor safety and effectiveness of services.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of meeting minutes, hospital documents, policy and procedure and interviews with staff, the hospital failed to have an ongoing quality program that included all processes of care and all hospital services. The facility failed to incorporate patient care data to improve the effectiveness and safety of patient care and improve health outcomes.

Findings:

1. On the morning of 8/30/2012 surveyors requested a copy of the Quality Assurance Performance Improvement Plan (QAPI) plans for 2011 and 2012. On the morning of 8/30/2012, Staff B told the surveyors the facility had identified "re-admissions, national patient safety goals, and implementing bundles as indicators for the (QAPI) 2012..."

Staff B stated the QAPI plan for 2012 encompassed July 01, 2011 through June 30, 2012. No plan was provided for 2013. Staff B stated the QAPI plan for 2013 should have been implemented on July 01, 2012. At the time of survey, no QAPI plan for 2013 had been developed, approved or implemented.

Staff B also told surveyors the QAPI data is reviewed in the Cancer Committee. There was no evidence re-admission, national patient safety goals, and implementing bundles were reviewed in the Cancer Committee meeting minutes. There was no evidence in the Governing Body Meeting Minutes, Medical Staff Meeting Minutes those indicators had been chosen, reviewed and analyzed as part of the QAPI plan.

Later in the morning, Staff B told surveyors the facility had recently changed committee structure and quality information would be found in a Clinical Leadership Committee. No evidence of the indicators Staff B gave surveyors was included in any of the meeting minutes reviewed. At that time, surveyors again requested Staff B provide the QAPI plans for 2011 and 2012.

At 1:30 p.m. on 8/30/2012, Staff B provided QAPI plans for 2011 and 2012. The plans did not include re-admissions, national patient safety goals, or implementing bundles. The plan(s) were identical. The plan(s) documented the hospital would report data on the following:

"... Key performance indicators, operative or other procedures that place patients at risk of disability or death; all significant discrepancies between preoperative and postoperative diagnoses, including pathologic diagnoses; adverse events related to using moderate or deep sedation or anesthesia, the use of blood and blood components and all confirmed transfusion reactions; the results of code blue resuscitation and early response through rapid response team calls; significant mediation errors; significant adverse drug reactions; patient and stakeholder perception of the safety and quality of care and treatment, and services; contracted care, treatment and services..."

There was no documentation hospital governance and medical staff reviewed and approved the plan. Documentation in meeting minutes did not reflect information provided in the QAPI plan.

At approximately 2:00 p.m., Staff D told surveyors the Strategic Planning documents included the indicators/processes the facility was addressing through the QAPI process. The processes identified in the Strategic planning documents did not include indicators which impact patient care or patient safety. There was no information in the meeting minutes these indicators had been selected due to high risk, low volume processes. Staff D told surveyors staff were allowed to select indicators and processes for their departments. Some of the Key Performance Indicators chosen by staff included:

"... reducing image reading turnaround time... software improvements/installs...clinic coordination of care... reducing the number of patients sent to outpatient services without orders and without being scheduled... decrease wait times... surgery scheduling process focusing on maximizing use of surgery capacity and staffing... chiropractic and oncology rehabilitation integration with a focus on elimination of lost opportunity of sharing patients..."

The only documentation in the Governing Body, Medical Staff, or Quality Committees related to QAPI included the number of projects completed, number of students who graduated from the Lean Six Sigma Program, process lead time, patient wait time, revenue impacted, cost reduction projected and net impact projected. There was no documentation stipulating these projects improved patient safety or care.

2. Surveyors reviewed facility documents which included two incidents the facility determined to be "sentinel events". Surveyors requested all documents related to the sentinel events. A review of Governing Body, Medical Staff, Cancer Committee, and Leadership meeting minutes did not include any review, analysis or plan for improvement on these events. One of the events included a root cause analysis (RCA). The other event did not have a root cause analysis. There was no documentation the committees reviewed the root cause analysis, analyzed the information and made recommendations to change patient care processes based on the information from the RCA.

At 12:00 p.m. on 8/30/2012, Staff B told surveyors she was told she could not document any information on the root cause analysis discussions. Later, Staff B and Staff C told surveyors a task force was set up from the RCA. Information provided from task force documents did not include any analysis of the RCA. Binder information included fall data specific to units after implementation of interventions. Surveyors could not find any information the RCA was analyzed and the information gained was used to make recommendations for changes in patient care. No committee meeting minutes reflected the information from the task force.

3. On 8/30/2012 surveyors reviewed Governing Body Meeting Minutes, Medical Staff Meeting Minutes, Cancer Committee, and Leadership Committee (CLIC). There was no information the facility utilized information from peer review processes, incident/occurrence reporting, patient care data, and environmental surveillance to monitor safety and effectiveness of services. There was no evidence the governing body approved the QA/PI program indicators selected and the frequency of data collection.

4. On the afternoon of 8/30/2012 surveyors selected three contract provider files. Staff B told surveyors one file was for a personal trainer. Two other contractor files were selected. Staff B told surveyors the contract was in the file but no evaluation of services had been done. The other file selected was not provided to surveyors. The facility failed to evaluate care/services provided for all hospital services.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on record review, policy and procedure review and staff interview, it was determined the hospital failed to set priorities for its performance improvement activities and failed to track the indicators from identification to resolution. Findings:

The Performance Improvement and Patient Safety Plan for FY 2012 documented, "... Performance Improvement Priorities... All performance improvement is centered on safe patient quality care and a culture of safety the following priority areas:...

Talent - Empowered stakeholders who deliver breakthrough results for out patients through a leadership culture that attract, develop, engages and empowers fully-performing stakeholders to positively encompass and impact the... culture...

Quality - Developing key indicators and metrics and consistently monitoring the results to exceed the highest standards and possibilities for our patients through the flawless execution of the Mother Standard in every interaction...

Profit - Maximizing return and realizing value for our patients and stakeholders through sound and consistent stewardship of our resources...

Growth - Serving more patients with cancer by leveraging innovation, creativity and talent, increasing access for more patients while differentiating our care..."

On 08/30/12, Staff B stated the QAPI plan for 2012 encompassed July 01, 2011 through June 30, 2012. No plan was provided for 2013. Staff B stated the QAPI plan for 2013 should have been implemented on July 01, 2012. At the time of survey, no QAPI plan for 2013 had been developed, approved or implemented.

Staff C was asked how priorities for performance improvement activities were determined. She stated there was no formal process identified in the plan. She was asked if there was documentation in meeting minutes or elsewhere to support what items were given priority. She stated she wasn't sure where that would be.

She was asked what QA/PI projects had priority. She stated, "Probably medication errors and fall." She was asked why these areas were chosen. She stated, "We had some serious incidents in those areas."

She was asked to provide patient safety or quality of care data that was analyzed and determined to be an area for improvement. The only data provided related to patient falls.

She was asked to provide documentation that demonstrated how interventions to correct problem areas were developed, evaluated and monitored for effectiveness.

No documentation was provided.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on record review and staff interview, it was determined the hospital failed to develop the QA/PI program to include how it would reduce medical errors and adverse events and how QA/PI activities and results would be tracked throughout the organization through committees and leadership entities. No single patient safety/quality of care performance improvement item could be traced from its identification through committee for analysis, action and response. Findings:

There was no documentation of a formalized QA/PI process to identify, measure, analyze and track medical errors and adverse events. The 2011 and 2012 QA/PI plans did not identify what patient safety and quality of care indicators would be the focus of the year's program.

There was no documentation of QA/PI activities designed to respond to identified causes of events and how preventive actions would be implemented. There was no evidence the hospital had mechanisms to gather feedback from staff when processes or procedures were implemented in response to adverse events.

There was no evidence of widespread staff training related to any specific patient safety or quality of care key performance indicator.

The Performance Improvement and Patient Safety Plans for FY 2011 and 2012 documented, "... Responsibility... The Governing Board is responsible for the quality of patient care provided. The Medical Executive Committee... strives to improve and sure provision of quality patient care through the monitoring assessment and evaluation of performance measurement and outcome. The Executive Leadership Steering Team and the Medical Executive committee assist in establishing priorities for organization-wide performance improvement activities and receive regular reports to ensure compliance with the intent of the program... All stakeholders have a significant role in the hospitals performance and are involved in the performance improvement activities. Managers are directly accountable to their vice-presidents and directors are accountable to the CEO for implementing annual quality goals in their departments. The Quality Director and Lean Six Sigma Operations Director oversee the ongoing, systematic process and offers education and support resources for all PI activities..."

Agenda items and meeting minutes were reviewed for 2011 and 2012 for the following committees: Clinical Leadership, Cancer Committee, Medical Executive and Governing Body. There were no meeting minutes provided for the Executive Leadership Steering Committee.

On 08/30/12, staff C stated the Cancer Committee was identified as the QA/PI committee.

January 2012 Cancer Committee meeting minutes were reviewed for evidence of QA/PI activities. None were documented.

On 08/30/12, staff H was asked to identify any single safety or quality of care performance improvement indicator from identification through resolution for 2011 or 2012. She stated the hospital had informally identified a potential for increased surgical site infection related to a specific procedure. She stated there were various interventions and actions taken related to this issue.

She was asked to provide documentation of this through the QA/PI process. She stated she recognized there was not a way to trace this through the organization. No documentation was provided.
VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS Tag No: A0297
Based on record review and staff interview, it was determined the hospital failed to conduct performance improvement projects that reflected the hospital's scope and complexity. Findings:

On 08/30/12, staff H stated the hospital provided specialty services to cancer patients that included investigational drugs, radiology and surgical procedures.

The Performance Improvement and Patient Safety Plan for FY 2012 documented, "... Scope of Services... The scope of our services is oncology and includes adult inpatient care, ambulatory care, distance support care and general medical surgical care..."

The plan did not document QA/PI indicators for each department within each service line.

Of those key performance indicators documented elsewhere, very few impacted high risk, high volume or problem prone areas. No key performance indicator documentation provided to the surveyors included medical error indicators. There were no key performance indicators that included new, or investigational patient care services.

The only patient safety performance indicator provided to the surveyors involved patient falls.

On 08/30/12, staff B was asked if the QA/PI program should focus on medical errors, adverse events and high risk areas. She stated it should. She was asked how areas for performance improvement were identified. She stated that information usually came from problems that had happened.

She was asked to provide documentation of meetings where data and information was presented to a committee to determine how the types and scope of projects for the QA/PI program for the year were selected.

That information was not provided.
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on record review and staff interview, it was determined the hospital failed to ensure the QA/PI program included all programs and services, including contract services. Findings:

The Performance Improvement and Patient Safety Plan for FY 2012 documented, "... Scope of Services... The scope of our services is oncology and includes adult inpatient care, ambulatory care, distance support care and general medical surgical care."

The hospital provided a list of contracted services that included supplemental nursing staff, a physical trainer and sleep study services.

The performance improvement plan did not include provisions for QA/PI indicators for each department within each service line. The plan did not address QA/PI for contracted services.

Of those key performance indicators documented elsewhere, very few impacted high risk, high volume or problem prone areas. No key performance indicator documentation provided to the surveyors included medical error indicators.

The only documentation of a patient safety performance indicator provided to the surveyors involved patient falls.

On 08/30/12, staff B was asked if the QA/PI program should focus on medical errors and adverse events. She stated it should.

Staff B was asked to provide documentation of QA/PI activities related to contract services. No documentation was provided.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on review of hospital documents, job descriptions, policy and procedure, Governing Board Minutes, Medical Staff Meeting Minutes, Quality Assurance Plans for 2011 and 2012, and interviews with staff, it was determined the hospital facility failed to ensure the CEO and the Governing Body had adequate oversight of the Quality Assurance and Performance Improvement program.

Findings:

1. On August 30, 2012 surveyors reviewed the Quality Assurance Performance Improvement (QAPI) plans for 2011 and 2012. The plan(s) both stipulate the facility will report data on the following: Key performance indicators, operative or other procedures that place patients at risk of disability or death; all significant discrepancies between preoperative and postoperative diagnoses, including pathologic diagnoses; adverse events related to using moderate or deep sedation or anesthesia, the use of blood and blood components and all confirmed transfusion reactions; the results of code blue resuscitation and early response through rapid response team calls; significant mediation errors; significant adverse drug reactions; patient and stakeholder perception of the safety and quality of care and treatment, and services; contracted care, treatment and services.

The plans were not modified based on ongoing analysis of patient safety data. The plans further stipulate, "...annually the Executive leadership, Medical Staff leadership, Lean Six Sigma Operations and the Quality Department will assess the performance improvement accomplishments, areas needing improvement, fulfillment of regulatory and accreditation standards, and applicability to our mission will be evaluated. These results will be used in part to establish the next year's plan..."

2. QAPI plans for 2011 and 2012 were identical. There were no changes based on problems identified through risk or surveillance.

3. There was no documentation in Governing Body Meeting Minutes or Medical Staff Meeting Minutes the plans had been reviewed and approved through governance. The plans did not have a date of approval or implementation. There was no documentation in the meeting minutes the governance followed the plan and annually evaluated the indicators to be used to establish the following year's plan.

4. On 8/30/12 surveyors reviewed Governing Body Bylaws. There was no stipulation in the bylaws or policies or the quality assurance plan the Governing Body was responsible for the quality and safety of patients through an ongoing program of quality improvement.

5. On 8/30/2012 surveyors reviewed the job description of the Chief Executive Officer (CEO) There was no stipulation the CEO is accountable for the effectiveness of the QAPI program. There are no meeting minutes (Governing Body, Medical Staff, Cancer Committee, or CLIC) stipulating the CEO is accountable for the program. The Governing Body Bylaws do not stipulate the CEO is accountable for the effectiveness of the QAPI program.
VIOLATION: HOSPITAL PROCEDURES Tag No: A0410
Based on variance reporting record review and staff interview, it was determined the hospital failed to have a mechanism to report drug administration errors, adverse drug reactions and incompatibilities to the QA/PI program. Findings:

On 08/30/12, staff C was asked what committee oversaw medication errors and other adverse drug events. She stated, "It used to be the clinical leadership committee and now it's the cancer committee."

Meeting minutes for both committees were reviewed for 2011 and 2012. There was no documentation these events were consistently addressed by these committees. Only one committee meeting had a statistical report on medication errors. The report addressed data from the first quarter of 2012.

The hospital did not provide policy and procedure that stipulated what events would be reported to the hospital-wide quality assurance program.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
Based on record review and staff interview, it was determined the hospital failed to have a mechanism to report drug administration errors, adverse drug reactions and incompatibilities to the QA/PI program. Findings:

On 08/30/12, staff C was asked what committee oversaw medication errors and other adverse drug events. She stated, "It used to be the clinical leadership committee and now it's the cancer committee."

Meeting minutes for both committees were reviewed for 2011 and 2012. There was no documentation these events were consistently addressed by these committees. Only one committee meeting had a statistical report on medication errors. The report addressed data from the first quarter of 2012.

The hospital did not provide policy and procedure that stipulated what events would be reported to the hospital-wide quality assurance program.
VIOLATION: LEADERSHIP RESPONSIBILITIES Tag No: A0756
Based on review of hospital documents and meeting minutes where infection control was to be reported, and infection control data provided, and interviews with hospital staff, the hospital's leadership failed to ensure infection control activities, issues, and problems, were reported to the Quality Assessment and Performance Improvement (QAPI) committee. The QAPI program failed to ensure infection control activities:

a. were monitored, reviewed and analyzed;

b. included corrective actions were taken to prevent, identify and manage infections and communicable diseases with measures that resulted in improvement on an ongoing basis; and

c. corrective actions were followed to ensure improvement was achieved and alternative solutions/actions were not needed.

Findings:

1. They surveyors were told that the CLIC (Clinical Leadership Improvement Council) committee, until recently, had been the hospital's QAPI function. They told the surveyors that just recently this had been changed to the Cancer Committee.

2. The hospital's most recent (2012) infection prevention plan documented the CLIC was responsible for reviewing, analyzing, and "monitoring the effectiveness" of the infection prevention program.

3. Infection control data provided showed hospital acquired infections. The QAPI meeting minutes (CLIC and Cancer) did not contain this information with review, analysis or plans of action taken to reduce infections. Only one meeting contain infection control information, but was only statistical information.

4. The QAPI program has not provided oversite of the infection control program to ensure a safe and sanitary environment. Meeting minutes did not contain review of the hospital's environment, disinfectants utilized by the hospital and their effectiveness or of employee immunizations, including influenza vaccinations.

5. Although the hospital, as of July 1, 2012, started into its 2013 fiscal year, the hospital leadership has not ensured the QAPI has reviewed and revised the Infection Control Plan.

6. These findings were reviewed and verified with Staff D and C on the afternoon of 08/30/2012.