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Based on interview and record review the facility Governing Body failed to ensure the Chief Executive Officer (CEO) was responsible for managing the entire facility including accountability for the effectiveness of the quality assessment and performance improvement (QAPI) program. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY (fiscal year) 12 (2012), Section V. Accountability / Responsibility" showed the following:
-The Board of Trustees {governing body}, Medical Executive Committee {physician leaders}, Professional Standards Committee {physician quality assessment leaders}, Performance Improvement Committee {facility department heads} and leaders play key roles in enabling systemic assessment and improvement of performance.
-The facility leaders provide the stimulus, vision, and resources that permit activities to be successfully implemented in an environment that fosters continuous improvement.
-They {the leaders} are responsible for setting priorities for improvement by reviewing reports that assess quality and performance improvement activities and for allocating necessary training and resources.

Appendix A of the plan showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis.
The seventeen indicators included:
-Composite scores (Centers for Medicare & Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice).
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia).
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff).
-Accidental Puncture or laceration.
-Infection from a Urinary Catheter.
-Average Length of Stay.
-Emergency Department throughput for discharged patients.

2. Record review of an undated list of the facility QAPI monitors, (provided during the survey by Staff B, Director of Quality and Risk Management) showed monitoring projects including the following:
-Intensive care unit staff were monitoring blood clot prevention, laboratory values, oral care, peptic ulcer disease prevention, sedation and extubation (removal of breathing tubes).
-Case Managers and Social workers were monitoring if patients signed a Medicare form on admission and the percentage of patient visits those staff perform.
-Laboratory staff was monitoring blood culture contaminations, proficiency testing in the lab, documentation of results, labeling of specimen.
-Pharmacy staff was monitoring controlled substances, order entries, medication errors, insulin orders and clarification orders.
-Surgery staff was monitoring delays in start times, quick sterilization of equipment and biological indicator results (used in equipment sterilization).
-Medical nursing unit staff was monitoring vaccines, pain assessment, wound photographs, patient activity orders, obstetrical charges and laboratory values.
-Emergency department staff was monitoring charges versus nurse documentation and staff peer review.

There was data collected on some of the monitors but the facility did not use the data to improve quality of care, patient safety or reduction of medical errors related to the quality indicators outlined in the facility QAPI plan

3. Record review of the facility's document titled, "Organizational Performance Improvement Plan FY 12", undated, showed approval signatures by the following:
- Chairman, Board of Trustees;
- President/CEO (Staff A); and
- President, Medical Staff.

4. During an interview on 08/21/12 from 10:05 AM through 10:59 AM Staff A, Chief Executive Officer (CEO) confirmed the list of facility monitors provided during the survey do not "match" the QAPI listing of quality performance indicators listed in the "Organizational Performance Improvement Plan FY12".

5. Record review of the facility's Hospital Database Worksheet dated 08/22/12 showed the facility had agreements (contracts) for the following patient care services:
-Anesthesia.
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones).
-Emergency psychiatry services.

6. Record review of the contracted services provided by Staff B, RN (Registered Nurse), Quality and Risk Manager, showed 356 services by contract or agreement. Of the contracted services approximately 25-30 provide direct clinical care to patients.

7. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility QAPI plan does not include contracted services.

8. During an interview on 08/21/12 at 11:12 AM, Staff A, CEO, stated the following:
-He was appointed by the Governing Body and was ultimately responsible for the facility-wide QAPI Program and the overall management of the facility.
-He was an active member of the Board of Trustees {governing body}, the Medical Executive Committee {physician leaders}, Professional Standards Committee {physician quality assessment leaders, and the Performance Improvement Committee {facility department heads).
-He also stated that Staff B reported directly to him for the QAPI Program.
-He signs (demonstrating approval) the facility QAPI plan.

Staff A stated that Staff G, RN, Infection Control Coordinator, was not a member of the QAPI Committee and did not present to the committee on infection control issues. He stated that she was not a Director and that it must have been an oversight.

9. During an interview on 08/21/12 at 2:15 PM, Staff B, RN, Quality and Risk Manager, stated that the QAPI program did not have any Policy and Procedures. Staff B stated she could not provide evidence of QAPI projects or performance improvement activities for any of the contracted services. She stated that she was not aware that the Organizational Performance Improvement Plan FY 12 did not contain guidance for analysis of data collected for QAPI projects.

10. Record review of the minutes from the monthly QAPI Committee Meetings for the past seven months (January, February, March, April, May, June, and July) showed the following for QAPI:
- "Report reviewed".
It was not evident by reviewing the QAPI Committee Meeting Minutes that QAPI was discussed or if new or old or pending projects were continuing, successful, unsuccessful or needed revisions in implementation for quality assurance and performance improvement.







27029

Based on interview and record review the Governing Body failed to ensure contracted patient care services were systematically and routinely assessed through the facility quality assessment/performance improvement plan (QAPI) for quality of service provided including identification of performance problems; implementation of corrective interventions and monitoring to ensure sustained correction. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012), Section III. Scope" approved by the Governing Body on 05/25/12 showed the Performance Improvement Plan was designed to provide the following:
-Objectively and systematically measure and evaluate the quality, appropriateness, and effectiveness of care;
-Continuously pursue opportunities for improvement.
-Resolve identified problems through interdisciplinary and interdepartmental collaboration.

Appendix A of the plan showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis.
The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice).
-Thirty day readmissions for Acute Myocardial Infarction (heart attack); Heart Failure and Pneumonia.
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff).
-Accidental Puncture or laceration.
-Infection from a Urinary Catheter.
-Average Length of Stay.
-Emergency Department throughput for discharged patients.

2. Record review of the facility's Hospital Database Worksheet dated 08/22/12 showed the facility had agreements (contracts) for the following patient care services:
-Anesthesia;
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones); and
-Emergency psychiatry services.
None of these contracted services were addressed in the facility QAPI plan.

3. Record review of the contracted services provided by Staff B, Registered Nurse, (RN), Quality and Risk Manager, showed 356 services by contract or agreement. Of the contracted services approximately 25-30 provided direct clinical care to patients.

4. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility QAPI plan does not include contracted services. Staff B stated she could not provide evidence of QAPI projects or performance improvement activities for any of the contracted services.





27029

Based on interview and record review the facility failed to develop data collected from the Labor and Delivery/Obstetrics Unit regarding inductions (a method of artificially or prematurely stimulating childbirth in a woman) performed by Family Practice Practitioners as compared to Obstetric Practitioners to formulate an organized QAPI safety indicator that directed specific data collection methods (numbers of cases, staff involved, outlined parameters, frequency over a specified time period) to be aggregated, analyzed and evaluated for remedial actions and interventions as needed. The facility also failed to outline the frequency detail of data collection in the annual plan approved by the governing body titled, "Organizational Performance Improvement Plan FY 12 (fiscal year 2012)". The facility census was 42.

Findings included:

1. Record review of the facility's undated brochure titled "We Have Your Health Care Needs Covered" showed the facility had "eight hundred births last year".

2. During an interview on 08/20/12 at 1:34 PM Staff E, Director of Obstetric (OB) Unit stated the following:
-One of the quality assessment/performance improvement projects being studied on the OB Unit was inductions performed by Family Practice Practitioners compared to inductions performed by OB Practitioners.
-Inductions by Family Practice Practitioners seemed to show less than optimal results than inductions by OB Practitioners.
-Less than optimal results were assessed by Pediatricians.
-The OB Unit had collected data on inductions for the last two to three years.
-The first year data collection was reported to the providers in Family Practice, Obstetrics and Pediatrics.
-No written documented interventions were added to the study parameters after the first, second or third year data collection.
-In the second and third years the data collection showed a decreased number of inductions by Family Practice Practitioners.
-Staff E stated that the decrease in number was probably due to the fact one of the Family Practice Practitioners stopped performing obstetrics at the facility, however was not able to support that with documented data.

3. During an interview on 08/21/12 at 1:06 PM Staff B Director of Quality and Risk Management stated the following:
-She was a part of data collection in that she put the information on the facility "score card".
-All departments reported any data they collected to her.
-The Labor and Delivery/Obstetrics data collection was not for a documented/written study.
-Discussion of the topic of inductions by Family Practice Practitioners as compared to OB Practitioners could not be proved because the Director of OB could not find minutes of the meeting (when the meeting occurred and who attended).
-The data collection showed inductions for less than thirty nine weeks of gestation but the data does not show who the practitioner was who induced the pregnant mother.
-No documented medical record was done.
-There was no documented policy or procedure written for the Labor and Delivery data collection.
-Staff B did not know who collected the data or if there was a standardized method to collect the data, review the data and analyze any trends or changes.
-Staff E just reported data to Staff B who records it on the "score card".
-The data was never reported to the QAPI Committee, it was only sent to the OB Practitioner staff.
-Staff B did not know if the Professional Standards Committee (physicians) had an approved format for data reporting; and
-When asked why this specific project was selected for continued data collection over two to three years, Staff B stated, "I doubt I could tell you."

4. Record review of the facility document titled, "Organizational Performance Improvement Plan FY 12 (fiscal year 2012)" showed the following:
- GOALS AND OBJECTIVES: Design quality and safe practice into the processes of care and develop systems, processes, and procedures . . .;
- Objectives to fulfill these goals are prioritized and approved annually by the facility's performance Improvement Committee, Professional Standards Committee, Medical Executive Committee and Board of Trustees;
- Utilize LEAN (a series of tools and techniques for managing the organization's processes to eliminate all non-value-added activities and waste from processes) tools and techniques in prioritized improvement activities.

The document gave direction on the facility's Performance Improvement Plan in the following areas:
- Definitions;
- Goals and Objectives;
- Scope;
- Methodology;
- Accountability/Responsibility;
- Reporting;
- Evaluation; and
- Confidentiality.
The document failed to provide direction for data collection or the frequency of data collection as a required component of the Organizational Performance Improvement Plan.








27029

Based on interview and record review the facility failed to:
-Analyze the data collected for the Quality Assurance and Performance Improvement (QAPI) Project from flash sterilization (immediate use steam sterilization) procedures to implement changes in processes for program improvements;
-Set priorities for its performance improvement activities that focused on high-risk, high-volume, or problem-prone areas. This had the potential to affect all patients in the facility for surgical procedure;.
-Take actions after receiving Labor and Delivery/Obstetrics Unit data regarding inductions (a method of artificially or prematurely stimulating childbirth in a woman) performed by Family Practice Practitioners as compared to Obstetric Practitioners to formulate interventions aimed at performance improvement and after implementation of the interventions, measure the success and track the performance based on the interventions to ensure sustained improvement. The facility census was 42.

Findings included:

1. Record review of the facility document titled, "Organizational Performance Improvement Plan FY 12 (fiscal year 2012)" showed the following:
- GOALS AND OBJECTIVES: Design quality and safe practice into the processes of care and develop systems, processes, and procedures;
- Objectives to fulfill these goals are prioritized and approved annually by the facility's Performance Improvement Committee, Professional Standards Committee, Medical Executive Committee and Board of Trustees;
- Utilize LEAN (a series of tools and techniques for managing the organization's processes and focuses on eliminating all non-value-added activities and waste from processes) tools and techniques in prioritized improvement activities.
The document gave direction on the facility's Performance Improvement Plan in the following areas:
- Definitions;
- Goals and Objectives;
- Scope;
- Methodology;
- Accountability/Responsibility;
- Reporting;
- Evaluation; and
- Confidentiality.
The document did not provide direction for data analysis as a required component of the Organizational Performance Improvement Plan.

Data analysis as it applies to the QAPI process is the process of evaluating data using analytical and logical reasoning to examine each component of the data provided. LEAN is a tool that provides cost-effective techniques to be used in the process of data analysis but is not in and of itself a process of analyzing data.

2. Record review of the Association of Perioperative Registered Nurses (AORN ) Standards, Recommended Practices, and Guidelines, 2010 provides the following recommendations for sterilization in the perioperative setting (the period of time from when the patient goes into the hospital for surgery until the time the patient is discharged home);
"Flash sterilization" has traditionally been used to describe steam sterilization cycles where unwrapped medical instruments are subjected to an abbreviated steam exposure time and then used promptly after cycle completion without being stored. This is in contrast to traditional "terminal sterilization" cycles, where instruments are sterilized within containers, wrappers, or primary packaging designed to maintain the instruments' sterility and allow the devices to be stored for later use. The term "flash" arose out of the abbreviated time of exposure of the unwrapped device.

The term "immediate-use steam sterilization" more accurately reflects the current use of these processes. The same critical reprocessing steps (such as cleaning, decontaminating, and transporting sterilized items) must be followed regardless of the specific sterilization cycle employed; a safe process does not include short-cuts or work-arounds. "Immediate use" is broadly defined as the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another.

Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.

3. Record review of the Centers for Disease Control (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, state the following:
RECOMMENDATIONS FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES
-Rationale: The ultimate goal of the Recommendations for Disinfection and Sterilization in Health-Care Facilities, 2008, is to reduce rates of health-care-associated infections through appropriate use of both disinfection and sterilization.
-Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save time.

4. Record review of the facility document titled, "2012 Flash Log and Biological Indicators" beginning January 2012 and monthly thereafter, showed the following:
Number of surgical cases Number of times surgical instruments
For the month: were flashed for a procedure:
January: 196 24
February 221 33
March 219 20
April 183 34
May 218 32
June 190 17
July 206 17

5. During an interview on 08/20/12 at 12:40 PM, Staff I, RN (Registered Nurse), Director of Intensive Care Unit and Surgical Services stated that one of the QAPI projects for the unit was flash sterilization.

6. During an interview on 08/21/12 at 2:15 PM, Staff B, RN, Quality Assurance and Risk Manager, stated there was no written plan for the flash sterilization QAPI project that specified the method and frequency of data collection and data collected with hospital methodology.

Staff B stated that the data was electronically derived from the hospitals electronic data system and was reviewed by Staff I and then submitted to her to be included in the hospital wide QAPI documentation.

Staff B, stated that Staff I, RN, Director of the Intensive Care Unit and Surgical Services, did not document the data analysis for the data collected from the flash sterilization performance improvement project and if any interventions were evaluated there was no documentation to reflect those interventions or evaluations.

Without evidence of data analysis or process intervention, the QAPI project was determined to be an exercise in monitoring the number of times flash sterilization was performed in the surgical procedures and did not result in process interventions, performance improvement or quality assurance.

During an interview on 08/21/12 at 2:22 PM, Staff B, RN, stated that the only QAPI projects that were prioritized as to high-risk, high-volume, or problem-prone areas were the projects for medication errors conducted by Staff F, Registered Pharmacist, Director of Pharmacy. She stated that all the other department projects were given a number that corresponded to severity of harm.

7. Record review of the facility's undated brochure titled "We Have Your Health Care Needs Covered" showed the facility had "eight hundred births last year".

8. During an interview on 08/20/12 at 1:34 PM Staff E, Director of Obstetric (OB) Unit stated the following:
-One of the quality assessment/performance improvement projects being studied on the OB Unit was inductions performed by Family Practice Practitioners compared to inductions performed by OB Practitioners.
-Inductions by Family Practice Practitioners seemed to show less than optimal results than inductions by OB Practitioners.
-Less than optimal results were assessed by Pediatricians.
-The OB Unit had collected data on inductions for the last two to three years.
-The first year data collection was reported to the providers in Family Practice, Obstetrics and Pediatrics.
-No written documented interventions were added to the study parameters after the first, second or third year data collection.
-No assessment of any interventions could be done because there were no interventions.
-In the second and third years the data collection showed a decreased number of inductions by Family Practice Practitioners.
-Staff E stated that the decrease in number was probably due to the fact one of the Family Practice Practitioners stopped performing obstetrics at the facility, however was not able to support that with documented data.
-No specific tracking was done to track performance improvement or to ensure changes (no interventions were established) that occurred were sustained or incidental.




16215

Based on interview and record review the facility failed to ensure the Quality Assessment/Performance Improvement (QAPI) program showed evidence of collaboration with the Infection Control (IC) Co-Ordinator in order to identify and track avoidable health care acquired infections. The facility also failed to conduct root cause analysis on adverse events or delineate risk factors for the adverse events. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012) Appendix A" showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis;
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice);
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia;.
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff).
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay;
-Emergency Department throughput for discharged patients.

2. During a telephone interview on 08/20/12 at 3:03 PM Staff G, Infection Control Co-ordinator stated that she did not have much interaction with the QAPI program or input into the QAPI plan.

During an interview on 08/21/12 at approximately 9:00 AM Staff G, Infection Control Co-ordinator stated the following:
-She was not a member of the facility QAPI committee;.
-She had her own catheter acquired urinary tract infection (CAUTI) committee that tracked indication for use of urinary catheters in the intensive care units and in the surgical areas;
-The committee formation was not due to an increase in urinary tract infections caused by urinary catheters.

3. During an interview on 08/21/12 at approximately 3:48 PM Staff B, RN, Quality Assurance and Risk Manager, stated that the facility had no CAUTI in the last eighteen months, but that Staff G continued to collect data for zero cases of CAUTI.
Staff B did not respond when asked why the facility monitored a performance improvement indicator that had no cases to study for the last eighteen months.

During an interview on 08/21/12 at 1:30 PM, Staff B, RN, stated that there have been no life threatening adverse events for the last 24 months and no deaths from adverse events.

4. Record review of the facility document titled, "Event Frequency by Notification Type" dated 08/20/12 showed the following without adverse event risk factors:
Notification Type Year to date
Against Medical Advice 11
Slip and Fall 63
Medication Event 380
Personal Property Loss 3
Test/Procedure/Treatment 76
The annual totals of adverse events for the facility were 533.

5. By request, Staff B, RN, created a facility document titled, "Event Frequency by Severity" dated 08/21/12. The document showed adverse events from 08/22/11 to 08/20/12 as follows:
EVENT NUMBER OF EVENTS SEVERITY
Medication event 57 Capacity to cause error
Medication event 50 Error did not reach patient
Medication event 195 Error, reached patient, no harm
Medication event 32 Increased monitoring, no harm
Medication event 5 Treatment intervention temporary harm
Test/Procedure/Treatment 1 Increased length of stay, temporary harm
Slip and Fall 4 Fractures
Slip and Fall 8 Laceration/Cut/Skin tear
Personal Property Loss 1 Other
Patient left against medical advice 15 Unknown
Total events were 411 for the last 12 month period.

6. During an interview on 08/21/12 at 2:30 PM, Staff B, RN, Quality and Risk Manager, stated that she had not completed any formal root cause analysis for the adverse events reported. She stated that they look at them and can usually figure out why they happened but no formal documented analyses were performed.






27029

Based on interview and record review the facility failed to provide evidence showing specific reasons for selection of each of the distinct performance improvement projects such as reduction of medical errors or performance improvement and the facility failed to show the selection of each of the Performance Improvement projects were reflective of the scope and complexity of the entire facility including patient care services provided by contractors. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012) Appendix A" showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis;
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate which only addresses a portion of the population treated by the facility;
-Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice) which provided patient perception of care but do not identify or decrease medical errors or performance improvement in specific identified areas;
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia) all without target rates established;
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff);
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay; and
-Emergency Department throughput for discharged patients.

2. Record review of an undated list of the facility QAPI monitors, (provided during the survey by Staff B, Registered Nurse (RN), Director of Quality and Risk Management) showed monitoring projects including the following:
-Intensive care unit staff were monitoring blood clot prevention, laboratory values, oral care, peptic ulcer disease prevention, sedation and extubation (removal of breathing tubes);
-Case Managers and Social workers were monitoring if patients signed a Medicare form on admission and the percentage of patient visits those staff performed;
-Laboratory staff was monitoring blood culture contaminations, proficiency testing in the lab, documentation of results, labeling of specimen;
-Pharmacy staff was monitoring controlled substances, order entries, medication errors, insulin orders and clarification of orders;
-Surgery staff was monitoring delays in start times, quick sterilization of equipment and biological indicator results (used in equipment sterilization);
-Medical nursing unit staff was monitoring vaccines, pain assessment, wound photographs, patient activity orders, obstetrical charges and laboratory values; and
-Emergency department staff was monitoring charges versus nurse documentation and staff peer review.
None of the monitors measured any factors that would assess the quality of care, patient safety or reduction of medical errors related to the performance/quality indicators outlined in the facility QAPI plan.

3. Record review of the facility's "FY12 Organizational Performance Indicators (Report Card)" provided during the survey showed results from 01/12 through 07/12 including the following:
-Patient satisfaction scores in all areas listed on the QAPI plan failed to meet the target in one or more reporting months, however no remedial studies were implemented to identify the reasons for patient dissatisfaction, remediate the problems and study the remediation to see if patient satisfaction was achieved and maintained;
-Rates for heart failure, acute myocardial infarct and pneumonia, immunization and SCIP were documented, however no monitors were in place to address months that fell below the stated target to identify why the target level was not achieved; and
-Accidental punctures and lacerations were identified problems in two of the seven months reported however no remedial studies were implemented to identify the reasons for patient dissatisfaction, remediate the problems and study the remediation to see if patient satisfaction was achieved and maintained.

4. During an interview on 08/21/12 at 10:05 AM Staff A, Chief Executive Officer confirmed the QAPI performance indicators did not coincide with the list of monitors/data collections done by selected departments.

5. During an interview on 08/21/12 at 1:06 PM Staff B, RN, Director of Quality and Risk Management confirmed the following:
-She was part of data collection from each of the departments in that she received the data and transcribed the numbers onto the score (report) card without review or comment;
-She confirmed that patient satisfaction surveying was not performance improvement;
-She doubted she could provide rationale for the selection of a specific project.

6. Record review of the facility's undated brochure titled "We Have Your Health Care Needs Covered" showed the facility had capability for the following patient care and services:
-Maternity center;
-Cardiac care;
-Emergency medicine team;
-General surgery including laparoscopic, endoscopy, non cardiac thoracic and peripheral vascular services;
-Advanced imaging and diagnostic radiology including CT scanner and MRI;
-Obstetrics and gynecology services;
-Orthopedic services;
-Pain management;
-Rehabilitation services; and
-Specialty services including dermatology, rheumatology, urology, oncology/hematology, neurology and pulmonology.

7. Record review of the Hospital Database Worksheet dated 08/22/12 showed the facility maintained services provided by contractors including the following:
-Anesthesia
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones).
-Emergency psychiatry services.
None of these contracted services were addressed in the facility QAPI plan.

The Hospital Database Worksheet also showed the facility provided some services through a combination of contractors plus facility staff including:
-Dietetic services;
-Emergency department;
-Magnetic Resonance Imaging (MRI);
-Nuclear Medicine;
-Ophthalmic Surgery (eye surgery);
-Pharmacy; and
-Diagnostic Radiology (x-ray images for clinical purposes).

8. Record review of the contracted services provided by Staff B, RN, Quality and Risk Manager, showed 356 services by contract or agreement. Of the contracted services approximately 25-30 provide direct clinical care to patients.

9. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility QAPI plan does not include contracted patient care services and she could not provide evidence of QAPI projects or performance improvement activities for any of the contracted services.





27029

Based on interview and record review the facility failed to ensure that the hospital-wide quality assurance performance improvement (QAPI) program included all departments and services including services by contract or agreement for anesthesia, extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones) and emergency psychiatry services. This had the potential to affect all patients in the facility. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012) Appendix A" showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis.
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice);
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia);
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff);
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay; and
-Emergency Department throughput for discharged patients.

2. Record review of the facility's contracted services showed approximately 25-30 contracted services included:
- Dietary services;
- Emergency room physicians;
- Ambulance services; and
- Hospice Services.

3. Record review of the facility's Hospital Database Worksheet dated 08/22/12 showed the facility had agreements (contracts) for the following patient care services:
-Anesthesia;
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones); and
-Emergency psychiatry services.

4. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility's QAPI plan does not include contracted services. Staff B stated that they periodically review the data that the contracted services collect for themselves but they do not have QAPI projects to evaluate the services provided to their patients.


16215

Based on interview and record review the Chief Executive Officer (CEO), medical staff members and administrative leaders failed to show accountability for the effectiveness of the quality assessment and performance improvement (QAPI) program by failing to ensure the facility performance indicators listed in the QAPI plan were monitored through appropriate data collection, analysis, activities and projects that were related to improving care and reduction of medical errors and the CEO, medical staff and administrative leaders failed to ensure the QAPI plan included assessment of performance of contractors who provided patient care services. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012), Section III. Scope, approved by the Governing Board, the Chief Executive Officer (CEO) and the President of the Medical Staff on 05/25/12, showed the Performance Improvement Plan was designed to provide the following:
-Objectively and systematically measure and evaluate the quality, appropriateness, and effectiveness of care;
-Continuously pursue opportunities for improvement; and
-Resolve identified problems through interdisciplinary and interdepartmental collaboration.

Appendix A of the plan showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis;
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice);
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia);
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff);
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay; and
-Emergency Department throughput for discharged patients.

2. Record review of an undated list of the facility QAPI monitors, (provided during the survey by Staff B, Director of Quality and Risk Management) showed monitoring projects including the following:
-Intensive care unit staff were monitoring blood clot prevention, laboratory values, oral care, peptic ulcer disease prevention, sedation and extubation (removal of breathing tubes);
-Case Managers and Social workers were monitoring if patients signed a Medicare form on admission and the percentage of patient visits those staff perform;
-Laboratory staff was monitoring blood culture contaminations, proficiency testing in the lab, documentation of results, labeling of specimen;
-Pharmacy staff was monitoring controlled substances, order entries, medication errors, insulin orders and clarification orders;
-Surgery staff was monitoring delays in start times, quick sterilization of equipment and biological indicator results (used in equipment sterilization);
-Medical nursing unit staff was monitoring vaccines, pain assessment, wound photographs, patient activity orders, obstetrical charges and laboratory values;
-Emergency department staff was monitoring charges versus nurse documentation and staff peer review;
The data collected on some of the monitors was not used to assess for problems, develop changes or interventions to improve quality of care, patient safety or reduction of medical errors related to the quality indicators outlined in the facility QAPI plan

3. Record review of the facility's Hospital Database Worksheet dated 08/22/12 showed the facility had agreements (contracts) for the following patient care services:
-Anesthesia;
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones); and
-Emergency psychiatry services.
None of these contracted services were addressed in the facility QAPI listing of performance indicators.

4. During an interview on 08/21/12 from 10:05 AM through 10:59 AM Staff A, Chief Executive Officer (CEO) confirmed the list of facility monitors provided during the survey do not "match" the QAPI listing of quality performance indicators listed in the "Organizational Performance Improvement Plan FY12".

5. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility QAPI plan does not include contracted services.

During an interview on 08/21/12 at 4:05 PM Staff B confirmed the facility did not have a written policy or procedure documenting the Governing Body's responsibilities or relationship for the facility's QAPI program.

Based on interview and record review the facility failed to ensure the Infection Control Co-ordinator maintained active collaboration with the quality assessment/performance improvement program (QAPI) to identify and track avoidable facility acquired infections. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY12 Appendix A" showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis;
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice);
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia);
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff);
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay; and
-Emergency Department throughput for discharged patients.

2. During a telephone interview on 08/20/12 at 3:03 PM Staff G, Registered Nurse (RN), Infection Control Co-ordinator stated that she did not have much interaction with the QAPI program or input into the QAPI plan.

During an interview on 08/21/12 at approximately 9:00 AM Staff G, RN, Infection Control Co-ordinator stated the following:
-She was not a member of the facility QAPI committee;
-She had her own catheter acquired urinary tract infection (CAUTI) committee that tracked indication for use of urinary catheters in the intensive care units and in the surgical areas;
-The committee formation was not due to an increase in urinary tract infections caused by urinary catheters.

3. During an interview on 08/21/12 at approximately 3:48 PM Staff B, RN, Director of Quality and Risk Management confirmed the following:
-The facility had no CAUTI in the last eighteen months.
-Staff G continued to collect data for zero cases of CAUTI.
Staff B did not respond when asked why the facility monitored a performance improvement indicator that had no cases to study for the last eighteen months.

4. During an interview on 08/21/12 at 10:04 AM, Staff A, CEO (Chief Executive Officer), stated that Staff G, RN, Infection Control Coordinator, was not a member of the QAPI Committee and did not present infection control issues to the committee. He stated that she was not a Director and that it must have been an oversight.




27029

Based on interview and record review the facility Governing Body failed to ensure the Chief Executive Officer (CEO) was responsible for managing the entire facility including accountability for the effectiveness of the quality assessment and performance improvement (QAPI) program. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY (fiscal year) 12 (2012), Section V. Accountability / Responsibility" showed the following:
-The Board of Trustees {governing body}, Medical Executive Committee {physician leaders}, Professional Standards Committee {physician quality assessment leaders}, Performance Improvement Committee {facility department heads} and leaders play key roles in enabling systemic assessment and improvement of performance.
-The facility leaders provide the stimulus, vision, and resources that permit activities to be successfully implemented in an environment that fosters continuous improvement.
-They {the leaders} are responsible for setting priorities for improvement by reviewing reports that assess quality and performance improvement activities and for allocating necessary training and resources.

Appendix A of the plan showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis.
The seventeen indicators included:
-Composite scores (Centers for Medicare & Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice).
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia).
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff).
-Accidental Puncture or laceration.
-Infection from a Urinary Catheter.
-Average Length of Stay.
-Emergency Department throughput for discharged patients.

2. Record review of an undated list of the facility QAPI monitors, (provided during the survey by Staff B, Director of Quality and Risk Management) showed monitoring projects including the following:
-Intensive care unit staff were monitoring blood clot prevention, laboratory values, oral care, peptic ulcer disease prevention, sedation and extubation (removal of breathing tubes).
-Case Managers and Social workers were monitoring if patients signed a Medicare form on admission and the percentage of patient visits those staff perform.
-Laboratory staff was monitoring blood culture contaminations, proficiency testing in the lab, documentation of results, labeling of specimen.
-Pharmacy staff was monitoring controlled substances, order entries, medication errors, insulin orders and clarification orders.
-Surgery staff was monitoring delays in start times, quick sterilization of equipment and biological indicator results (used in equipment sterilization).
-Medical nursing unit staff was monitoring vaccines, pain assessment, wound photographs, patient activity orders, obstetrical charges and laboratory values.
-Emergency department staff was monitoring charges versus nurse documentation and staff peer review.

There was data collected on some of the monitors but the facility did not use the data to improve quality of care, patient safety or reduction of medical errors related to the quality indicators outlined in the facility QAPI plan

3. Record review of the facility's document titled, "Organizational Performance Improvement Plan FY 12", undated, showed approval signatures by the following:
- Chairman, Board of Trustees;
- President/CEO (Staff A); and
- President, Medical Staff.

4. During an interview on 08/21/12 from 10:05 AM through 10:59 AM Staff A, Chief Executive Officer (CEO) confirmed the list of facility monitors provided during the survey do not "match" the QAPI listing of quality performance indicators listed in the "Organizational Performance Improvement Plan FY12".

5. Record review of the facility's Hospital Database Worksheet dated 08/22/12 showed the facility had agreements (contracts) for the following patient care services:
-Anesthesia.
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones).
-Emergency psychiatry services.

6. Record review of the contracted services provided by Staff B, RN (Registered Nurse), Quality and Risk Manager, showed 356 services by contract or agreement. Of the contracted services approximately 25-30 provide direct clinical care to patients.

7. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility QAPI plan does not include contracted services.

8. During an interview on 08/21/12 at 11:12 AM, Staff A, CEO, stated the following:
-He was appointed by the Governing Body and was ultimately responsible for the facility-wide QAPI Program and the overall management of the facility.
-He was an active member of the Board of Trustees {governing body}, the Medical Executive Committee {physician leaders}, Professional Standards Committee {physician quality assessment leaders, and the Performance Improvement Committee {facility department heads).
-He also stated that Staff B reported directly to him for the QAPI Program.
-He signs (demonstrating approval) the facility QAPI plan.

Staff A stated that Staff G, RN, Infection Control Coordinator, was not a member of the QAPI Committee and did not present to the committee on infection control issues. He stated that she was not a Director and that it must have been an oversight.

9. During an interview on 08/21/12 at 2:15 PM, Staff B, RN, Quality and Risk Manager, stated that the QAPI program did not have any Policy and Procedures. Staff B stated she could not provide evidence of QAPI projects or performance improvement activities for any of the contracted services. She stated that she was not aware that the Organizational Performance Improvement Plan FY 12 did not contain guidance for analysis of data collected for QAPI projects.

10. Record review of the minutes from the monthly QAPI Committee Meetings for the past seven months (January, February, March, April, May, June, and July) showed the following for QAPI:
- "Report reviewed".
It was not evident by reviewing the QAPI Committee Meeting Minutes that QAPI was discussed or if new or old or pending projects were continuing, successful, unsuccessful or needed revisions in implementation for quality assurance and performance improvement.







27029

Based on interview and record review the Governing Body failed to ensure contracted patient care services were systematically and routinely assessed through the facility quality assessment/performance improvement plan (QAPI) for quality of service provided including identification of performance problems; implementation of corrective interventions and monitoring to ensure sustained correction. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012), Section III. Scope" approved by the Governing Body on 05/25/12 showed the Performance Improvement Plan was designed to provide the following:
-Objectively and systematically measure and evaluate the quality, appropriateness, and effectiveness of care;
-Continuously pursue opportunities for improvement.
-Resolve identified problems through interdisciplinary and interdepartmental collaboration.

Appendix A of the plan showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis.
The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice).
-Thirty day readmissions for Acute Myocardial Infarction (heart attack); Heart Failure and Pneumonia.
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff).
-Accidental Puncture or laceration.
-Infection from a Urinary Catheter.
-Average Length of Stay.
-Emergency Department throughput for discharged patients.

2. Record review of the facility's Hospital Database Worksheet dated 08/22/12 showed the facility had agreements (contracts) for the following patient care services:
-Anesthesia;
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones); and
-Emergency psychiatry services.
None of these contracted services were addressed in the facility QAPI plan.

3. Record review of the contracted services provided by Staff B, Registered Nurse, (RN), Quality and Risk Manager, showed 356 services by contract or agreement. Of the contracted services approximately 25-30 provided direct clinical care to patients.

4. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility QAPI plan does not include contracted services. Staff B stated she could not provide evidence of QAPI projects or performance improvement activities for any of the contracted services.





27029

Based on interview and record review the facility failed to develop data collected from the Labor and Delivery/Obstetrics Unit regarding inductions (a method of artificially or prematurely stimulating childbirth in a woman) performed by Family Practice Practitioners as compared to Obstetric Practitioners to formulate an organized QAPI safety indicator that directed specific data collection methods (numbers of cases, staff involved, outlined parameters, frequency over a specified time period) to be aggregated, analyzed and evaluated for remedial actions and interventions as needed. The facility also failed to outline the frequency detail of data collection in the annual plan approved by the governing body titled, "Organizational Performance Improvement Plan FY 12 (fiscal year 2012)". The facility census was 42.

Findings included:

1. Record review of the facility's undated brochure titled "We Have Your Health Care Needs Covered" showed the facility had "eight hundred births last year".

2. During an interview on 08/20/12 at 1:34 PM Staff E, Director of Obstetric (OB) Unit stated the following:
-One of the quality assessment/performance improvement projects being studied on the OB Unit was inductions performed by Family Practice Practitioners compared to inductions performed by OB Practitioners.
-Inductions by Family Practice Practitioners seemed to show less than optimal results than inductions by OB Practitioners.
-Less than optimal results were assessed by Pediatricians.
-The OB Unit had collected data on inductions for the last two to three years.
-The first year data collection was reported to the providers in Family Practice, Obstetrics and Pediatrics.
-No written documented interventions were added to the study parameters after the first, second or third year data collection.
-In the second and third years the data collection showed a decreased number of inductions by Family Practice Practitioners.
-Staff E stated that the decrease in number was probably due to the fact one of the Family Practice Practitioners stopped performing obstetrics at the facility, however was not able to support that with documented data.

3. During an interview on 08/21/12 at 1:06 PM Staff B Director of Quality and Risk Management stated the following:
-She was a part of data collection in that she put the information on the facility "score card".
-All departments reported any data they collected to her.
-The Labor and Delivery/Obstetrics data collection was not for a documented/written study.
-Discussion of the topic of inductions by Family Practice Practitioners as compared to OB Practitioners could not be proved because the Director of OB could not find minutes of the meeting (when the meeting occurred and who attended).
-The data collection showed inductions for less than thirty nine weeks of gestation but the data does not show who the practitioner was who induced the pregnant mother.
-No documented medical record was done.
-There was no documented policy or procedure written for the Labor and Delivery data collection.
-Staff B did not know who collected the data or if there was a standardized method to collect the data, review the data and analyze any trends or changes.
-Staff E just reported data to Staff B who records it on the "score card".
-The data was never reported to the QAPI Committee, it was only sent to the OB Practitioner staff.
-Staff B did not know if the Professional Standards Committee (physicians) had an approved format for data reporting; and
-When asked why this specific project was selected for continued data collection over two to three years, Staff B stated, "I doubt I could tell you."

4. Record review of the facility document titled, "Organizational Performance Improvement Plan FY 12 (fiscal year 2012)" showed the following:
- GOALS AND OBJECTIVES: Design quality and safe practice into the processes of care and develop systems, processes, and procedures . . .;
- Objectives to fulfill these goals are prioritized and approved annually by the facility's performance Improvement Committee, Professional Standards Committee, Medical Executive Committee and Board of Trustees;
- Utilize LEAN (a series of tools and techniques for managing the organization's processes to eliminate all non-value-added activities and waste from processes) tools and techniques in prioritized improvement activities.

The document gave direction on the facility's Performance Improvement Plan in the following areas:
- Definitions;
- Goals and Objectives;
- Scope;
- Methodology;
- Accountability/Responsibility;
- Reporting;
- Evaluation; and
- Confidentiality.
The document failed to provide direction for data collection or the frequency of data collection as a required component of the Organizational Performance Improvement Plan.








27029

Based on interview and record review the facility failed to:
-Analyze the data collected for the Quality Assurance and Performance Improvement (QAPI) Project from flash sterilization (immediate use steam sterilization) procedures to implement changes in processes for program improvements;
-Set priorities for its performance improvement activities that focused on high-risk, high-volume, or problem-prone areas. This had the potential to affect all patients in the facility for surgical procedure;.
-Take actions after receiving Labor and Delivery/Obstetrics Unit data regarding inductions (a method of artificially or prematurely stimulating childbirth in a woman) performed by Family Practice Practitioners as compared to Obstetric Practitioners to formulate interventions aimed at performance improvement and after implementation of the interventions, measure the success and track the performance based on the interventions to ensure sustained improvement. The facility census was 42.

Findings included:

1. Record review of the facility document titled, "Organizational Performance Improvement Plan FY 12 (fiscal year 2012)" showed the following:
- GOALS AND OBJECTIVES: Design quality and safe practice into the processes of care and develop systems, processes, and procedures;
- Objectives to fulfill these goals are prioritized and approved annually by the facility's Performance Improvement Committee, Professional Standards Committee, Medical Executive Committee and Board of Trustees;
- Utilize LEAN (a series of tools and techniques for managing the organization's processes and focuses on eliminating all non-value-added activities and waste from processes) tools and techniques in prioritized improvement activities.
The document gave direction on the facility's Performance Improvement Plan in the following areas:
- Definitions;
- Goals and Objectives;
- Scope;
- Methodology;
- Accountability/Responsibility;
- Reporting;
- Evaluation; and
- Confidentiality.
The document did not provide direction for data analysis as a required component of the Organizational Performance Improvement Plan.

Data analysis as it applies to the QAPI process is the process of evaluating data using analytical and logical reasoning to examine each component of the data provided. LEAN is a tool that provides cost-effective techniques to be used in the process of data analysis but is not in and of itself a process of analyzing data.

2. Record review of the Association of Perioperative Registered Nurses (AORN ) Standards, Recommended Practices, and Guidelines, 2010 provides the following recommendations for sterilization in the perioperative setting (the period of time from when the patient goes into the hospital for surgery until the time the patient is discharged home);
"Flash sterilization" has traditionally been used to describe steam sterilization cycles where unwrapped medical instruments are subjected to an abbreviated steam exposure time and then used promptly after cycle completion without being stored. This is in contrast to traditional "terminal sterilization" cycles, where instruments are sterilized within containers, wrappers, or primary packaging designed to maintain the instruments' sterility and allow the devices to be stored for later use. The term "flash" arose out of the abbreviated time of exposure of the unwrapped device.

The term "immediate-use steam sterilization" more accurately reflects the current use of these processes. The same critical reprocessing steps (such as cleaning, decontaminating, and transporting sterilized items) must be followed regardless of the specific sterilization cycle employed; a safe process does not include short-cuts or work-arounds. "Immediate use" is broadly defined as the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another.

Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.

3. Record review of the Centers for Disease Control (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, state the following:
RECOMMENDATIONS FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES
-Rationale: The ultimate goal of the Recommendations for Disinfection and Sterilization in Health-Care Facilities, 2008, is to reduce rates of health-care-associated infections through appropriate use of both disinfection and sterilization.
-Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save time.

4. Record review of the facility document titled, "2012 Flash Log and Biological Indicators" beginning January 2012 and monthly thereafter, showed the following:
Number of surgical cases Number of times surgical instruments
For the month: were flashed for a procedure:
January: 196 24
February 221 33
March 219 20
April 183 34
May 218 32
June 190 17
July 206 17

5. During an interview on 08/20/12 at 12:40 PM, Staff I, RN (Registered Nurse), Director of Intensive Care Unit and Surgical Services stated that one of the QAPI projects for the unit was flash sterilization.

6. During an interview on 08/21/12 at 2:15 PM, Staff B, RN, Quality Assurance and Risk Manager, stated there was no written plan for the flash sterilization QAPI project that specified the method and frequency of data collection and data collected with hospital methodology.

Staff B stated that the data was electronically derived from the hospitals electronic data system and was reviewed by Staff I and then submitted to her to be included in the hospital wide QAPI documentation.

Staff B, stated that Staff I, RN, Director of the Intensive Care Unit and Surgical Services, did not document the data analysis for the data collected from the flash sterilization performance improvement project and if any interventions were evaluated there was no documentation to reflect those interventions or evaluations.

Without evidence of data analysis or process intervention, the QAPI project was determined to be an exercise in monitoring the number of times flash sterilization was performed in the surgical procedures and did not result in process interventions, performance improvement or quality assurance.

During an interview on 08/21/12 at 2:22 PM, Staff B, RN, stated that the only QAPI projects that were prioritized as to high-risk, high-volume, or problem-prone areas were the projects for medication errors conducted by Staff F, Registered Pharmacist, Director of Pharmacy. She stated that all the other department projects were given a number that corresponded to severity of harm.

7. Record review of the facility's undated brochure titled "We Have Your Health Care Needs Covered" showed the facility had "eight hundred births last year".

8. During an interview on 08/20/12 at 1:34 PM Staff E, Director of Obstetric (OB) Unit stated the following:
-One of the quality assessment/performance improvement projects being studied on the OB Unit was inductions performed by Family Practice Practitioners compared to inductions performed by OB Practitioners.
-Inductions by Family Practice Practitioners seemed to show less than optimal results than inductions by OB Practitioners.
-Less than optimal results were assessed by Pediatricians.
-The OB Unit had collected data on inductions for the last two to three years.
-The first year data collection was reported to the providers in Family Practice, Obstetrics and Pediatrics.
-No written documented interventions were added to the study parameters after the first, second or third year data collection.
-No assessment of any interventions could be done because there were no interventions.
-In the second and third years the data collection showed a decreased

Based on interview and record review the facility failed to ensure the Quality Assessment/Performance Improvement (QAPI) program showed evidence of collaboration with the Infection Control (IC) Co-Ordinator in order to identify and track avoidable health care acquired infections. The facility also failed to conduct root cause analysis on adverse events or delineate risk factors for the adverse events. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012) Appendix A" showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis;
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice);
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia;.
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff).
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay;
-Emergency Department throughput for discharged patients.

2. During a telephone interview on 08/20/12 at 3:03 PM Staff G, Infection Control Co-ordinator stated that she did not have much interaction with the QAPI program or input into the QAPI plan.

During an interview on 08/21/12 at approximately 9:00 AM Staff G, Infection Control Co-ordinator stated the following:
-She was not a member of the facility QAPI committee;.
-She had her own catheter acquired urinary tract infection (CAUTI) committee that tracked indication for use of urinary catheters in the intensive care units and in the surgical areas;
-The committee formation was not due to an increase in urinary tract infections caused by urinary catheters.

3. During an interview on 08/21/12 at approximately 3:48 PM Staff B, RN, Quality Assurance and Risk Manager, stated that the facility had no CAUTI in the last eighteen months, but that Staff G continued to collect data for zero cases of CAUTI.
Staff B did not respond when asked why the facility monitored a performance improvement indicator that had no cases to study for the last eighteen months.

During an interview on 08/21/12 at 1:30 PM, Staff B, RN, stated that there have been no life threatening adverse events for the last 24 months and no deaths from adverse events.

4. Record review of the facility document titled, "Event Frequency by Notification Type" dated 08/20/12 showed the following without adverse event risk factors:
Notification Type Year to date
Against Medical Advice 11
Slip and Fall 63
Medication Event 380
Personal Property Loss 3
Test/Procedure/Treatment 76
The annual totals of adverse events for the facility were 533.

5. By request, Staff B, RN, created a facility document titled, "Event Frequency by Severity" dated 08/21/12. The document showed adverse events from 08/22/11 to 08/20/12 as follows:
EVENT NUMBER OF EVENTS SEVERITY
Medication event 57 Capacity to cause error
Medication event 50 Error did not reach patient
Medication event 195 Error, reached patient, no harm
Medication event 32 Increased monitoring, no harm
Medication event 5 Treatment intervention temporary harm
Test/Procedure/Treatment 1 Increased length of stay, temporary harm
Slip and Fall 4 Fractures
Slip and Fall 8 Laceration/Cut/Skin tear
Personal Property Loss 1 Other
Patient left against medical advice 15 Unknown
Total events were 411 for the last 12 month period.

6. During an interview on 08/21/12 at 2:30 PM, Staff B, RN, Quality and Risk Manager, stated that she had not completed any formal root cause analysis for the adverse events reported. She stated that they look at them and can usually figure out why they happened but no formal documented analyses were performed.






27029

Based on interview and record review the facility failed to provide evidence showing specific reasons for selection of each of the distinct performance improvement projects such as reduction of medical errors or performance improvement and the facility failed to show the selection of each of the Performance Improvement projects were reflective of the scope and complexity of the entire facility including patient care services provided by contractors. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012) Appendix A" showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis;
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate which only addresses a portion of the population treated by the facility;
-Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice) which provided patient perception of care but do not identify or decrease medical errors or performance improvement in specific identified areas;
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia) all without target rates established;
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff);
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay; and
-Emergency Department throughput for discharged patients.

2. Record review of an undated list of the facility QAPI monitors, (provided during the survey by Staff B, Registered Nurse (RN), Director of Quality and Risk Management) showed monitoring projects including the following:
-Intensive care unit staff were monitoring blood clot prevention, laboratory values, oral care, peptic ulcer disease prevention, sedation and extubation (removal of breathing tubes);
-Case Managers and Social workers were monitoring if patients signed a Medicare form on admission and the percentage of patient visits those staff performed;
-Laboratory staff was monitoring blood culture contaminations, proficiency testing in the lab, documentation of results, labeling of specimen;
-Pharmacy staff was monitoring controlled substances, order entries, medication errors, insulin orders and clarification of orders;
-Surgery staff was monitoring delays in start times, quick sterilization of equipment and biological indicator results (used in equipment sterilization);
-Medical nursing unit staff was monitoring vaccines, pain assessment, wound photographs, patient activity orders, obstetrical charges and laboratory values; and
-Emergency department staff was monitoring charges versus nurse documentation and staff peer review.
None of the monitors measured any factors that would assess the quality of care, patient safety or reduction of medical errors related to the performance/quality indicators outlined in the facility QAPI plan.

3. Record review of the facility's "FY12 Organizational Performance Indicators (Report Card)" provided during the survey showed results from 01/12 through 07/12 including the following:
-Patient satisfaction scores in all areas listed on the QAPI plan failed to meet the target in one or more reporting months, however no remedial studies were implemented to identify the reasons for patient dissatisfaction, remediate the problems and study the remediation to see if patient satisfaction was achieved and maintained;
-Rates for heart failure, acute myocardial infarct and pneumonia, immunization and SCIP were documented, however no monitors were in place to address months that fell below the stated target to identify why the target level was not achieved; and
-Accidental punctures and lacerations were identified problems in two of the seven months reported however no remedial studies were implemented to identify the reasons for patient dissatisfaction, remediate the problems and study the remediation to see if patient satisfaction was achieved and maintained.

4. During an interview on 08/21/12 at 10:05 AM Staff A, Chief Executive Officer confirmed the QAPI performance indicators did not coincide with the list of monitors/data collections done by selected departments.

5. During an interview on 08/21/12 at 1:06 PM Staff B, RN, Director of Quality and Risk Management confirmed the following:
-She was part of data collection from each of the departments in that she received the data and transcribed the numbers onto the score (report) card without review or comment;
-She confirmed that patient satisfaction surveying was not performance improvement;
-She doubted she could provide rationale for the selection of a specific project.

6. Record review of the facility's undated brochure titled "We Have Your Health Care Needs Covered" showed the facility had capability for the following patient care and services:
-Maternity center;
-Cardiac care;
-Emergency medicine team;
-General surgery including laparoscopic, endoscopy, non cardiac thoracic and peripheral vascular services;
-Advanced imaging and diagnostic radiology including CT scanner and MRI;
-Obstetrics and gynecology services;
-Orthopedic services;
-Pain management;
-Rehabilitation services; and
-Specialty services including dermatology, rheumatology, urology, oncology/hematology, neurology and pulmonology.

7. Record review of the Hospital Database Worksheet dated 08/22/12 showed the facility maintained services provided by contractors including the following:
-Anesthesia
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones).
-Emergency psychiatry services.
None of these contracted services were addressed in the facility QAPI plan.

The Hospital Database Worksheet also showed the facility provided some services through a combination of contractors plus facility staff including:
-Dietetic services;
-Emergency department;
-Magnetic Resonance Imaging (MRI);
-Nuclear Medicine;
-Ophthalmic Surgery (eye surgery);
-Pharmacy; and
-Diagnostic Radiology (x-ray images for clinical purposes).

8. Record review of the contracted services provided by Staff B, RN, Quality and Risk Manager, showed 356 services by contract or agreement. Of the contracted services approximately 25-30 provide direct clinical care to patients.

9. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility QAPI plan does not include contracted patient care services and she could not provide evidence of QAPI projects or performance improvement activities for any of the contracted services.





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Based on interview and record review the facility failed to ensure that the hospital-wide quality assurance performance improvement (QAPI) program included all departments and services including services by contract or agreement for anesthesia, extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones) and emergency psychiatry services. This had the potential to affect all patients in the facility. The facility census was 42.

Findings included:

1. Record review of the facility "Organizational Performance Improvement Plan FY 12 (fiscal year 2012) Appendix A" showed the following:
-A summary of seventeen indicators reported to the Board of Trustees, Medical Executive Committee, Professional Standards Committee and the Performance Improvement Committee on a monthly and/or quarterly basis.
-The seventeen indicators included:
-Composite scores (Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting) for Pneumonia and Surgical Care Improvement Project (SCIP).
-Pneumococcal Immunization (pneumonia vaccine) Rate; Patient satisfaction (Inpatient; Emergency; Ambulatory Surgery/Endoscopy; Outpatient Departments; Medical practice);
-Thirty day readmissions (Acute Myocardial Infarction (heart attack); Heart Failure; Pneumonia);
-Adult Iatrogenic Pneumothorax (air in the area around the lung due to mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention by staff);
-Accidental Puncture or laceration;
-Infection from a Urinary Catheter;
-Average Length of Stay; and
-Emergency Department throughput for discharged patients.

2. Record review of the facility's contracted services showed approximately 25-30 contracted services included:
- Dietary services;
- Emergency room physicians;
- Ambulance services; and
- Hospice Services.

3. Record review of the facility's Hospital Database Worksheet dated 08/22/12 showed the facility had agreements (contracts) for the following patient care services:
-Anesthesia;
-Extracorporeal shock wave lithotripter (outside the body sound waves to break up kidney stones); and
-Emergency psychiatry services.

4. During an interview on 08/21/12 at 10:59 AM Staff B, Director of Quality and Risk Management confirmed the facility's QAPI plan does not include contracted services. Staff B stated that they periodically review the data that the contracted services collect for themselves but they do not have QAPI projects to evaluate the services provided to their patients.


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