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.

HIGHLANDS REGIONAL MEDICAL CENTER 3600 S HIGHLANDS AVE SEBRING, FL 33870 April 25, 2013
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on document review and staff interview it was determined the Chief Executive Officer (CEO) failed to ensure quality review of the interventional cardiology program, outpatient wound care center that included hyperbaric therapy and the sleep study laboratory.

Findings include:

During review of the quality monitors for the interventional cardiology program, it was noted there was no tracking or trending of patient outcomes related to the service. The only data presented was meeting minutes from the STEMI committee. The only physician involved was the only interventional cardiologist on staff. There was documentation that the cases were reviewed, but no analysis of the findings and no reports generated to quality committee, medical executive committee or governing body.

The CEO was interviewed on 4/25/13 at 12:35 p.m. and confirmed there was no monitoring of the program and patient outcomes beyond the discussions in the STEMI meetings. He stated that he had relied on the Chief Nursing Officer to oversee the program and failed to recognize the deficiencies until recently.

Review of the meeting minutes for the quality committee revealed that in addition to there being no review of the interventional cardiology program, there was also no review of the wound care center, hyperbaric services or the sleep laboratory.

During interview on 4/25/13 at approximately 2:00 p.m. the Risk Manager also confirmed there was no documentation of quality monitoring of these programs.

During the entrance conference on 4/24/13 at approximately 9:00 a.m. the CEO stated the cardiac catheterization laboratory was temporarily closed due to renovation and installation of new equipment. He stated the procedures were being done in the Operating Room utilizing a C-Arm since 4/8/13. During tour of the cardiac catheterization laboratory on 4/24/13 at approximately 9:30 a.m. it was revealed the laboratory was under going renovations. Review of the quality documentation revealed no evidence of monitoring while services were being provided in the different location utilizing a C-arm.
VIOLATION: QAPI Tag No: A0263
Based on document review and staff interview it was determined the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program for the facility's interventional cardiac program, outpatient wound care that included hyperbaric therapy and the sleep study laboratory clinical programs. The 126 bed facility performed 167 interventional cardiac catheterization procedures since June 2012. The facility:

Failed to ensure an ongoing program with measurable improvement indicators and failed to measure, analyze and track quality indicators to assess the processes of care, service and operations related to the interventional cardiology program, outpatient wound care center that includes hyperbaric therapy and sleep studies laboratory. (Refer to A0273)


Failed to have a process in place to analyze data related to the interventional cardiology program, the outpatient wound care center that includes hyperbaric services and the sleep studies laboratory. (Refer to A0283)


Failed to ensure quality review of the interventional cardiology program, the outpatient wound care center that includes hyperbaric services and the sleep laboratory. (Refer to A0308)

The Chief Executive Officer (CEO) failed to ensure quality review of the interventional cardiology program, outpatient wound care center that included hyperbaric therapy and the sleep studies laboratory. (Refer to A0309)

During the entrance conference on 4/24/13 at approximately 9:00 a.m. the CEO stated the cardiac catheterization laboratory was temporarily closed due to renovation and installation of new equipment. He stated the procedures were being done in the Operating Room utilizing a C-Arm since 4/8/13. Review of the quality documentation revealed no evidence of monitoring while services were being provided in the different location utilizing a C-arm.

The cumulative effect of the lack of a quality assessment performance improvement plan for the interventional cardiology, outpatient wound care with hyperbaric therapy and the sleep study programs resulted in the determination of non-compliance with the Condition of Participation for Quality Assessment and Performance Improvement.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on document review and staff interview it was determined the facility failed to ensure an ongoing program with measurable improvement indicators and failed to measure, analyze and track quality indicators to assess the processes of care, service and operations related to the interventional cardiology program, outpatient wound care center that includes hyperbaric therapy and sleep study laboratory.

Findings include:

During review of the quality monitors for the interventional cardiology program on 4/25/13, it was noted there was no documentation of data collection related to the program that was initiated in June 2012. The only data presented was meeting minutes from the STEMI committee. The only physician involved was the only interventional cardiologist on staff. There was documentation the cases were reviewed, but there was no evidence of any quality indicators that would evaluate effectiveness and quality of the services provided. The Director of Critical Care provided documentation that there had been 167 procedures since June 2012.

The Chief Executive Officer was interviewed on 4/25/13 at 12:35 p.m. and confirmed there was no monitoring of the program and patient outcomes beyond the discussions in the STEMI meeting.

Review of the meeting minutes for the quality committee revealed that in addition to there being no review of the interventional cardiology program, there was also no evidence of data collection related to the outpatient wound care center that included hyperbaric services and the sleep study laboratory.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on document review and staff interview it was determined the facility failed to have a process in place to analyze data related to the interventional cardiology program, the outpatient wound care center that includes hyperbaric services and the sleep study laboratory.

Findings include:

During review of the quality monitors for the interventional cardiology program, it was noted there was no tracking or trending of patient outcomes related to the service. The only data presented was meeting minutes from the STEMI committee. The only physician involved was the only interventional cardiologist on staff. There was documentation that the cases were reviewed, but no analysis of the findings and no reports generated to quality committee, medical executive committee or governing body.

The Chief Executive Officer was interviewed on 4/25/13 at 12:35 p.m. and confirmed that there was no monitoring of the program and patient outcomes beyond the discussions in the STEMI meetings.

Review of the meeting minutes for the quality committee revealed that in addition to there being no review of the interventional cardiology program, there was also no review of the wound care center including hyperbaric therapy or the sleep laboratory.

On 4/25/13 at approximately 2:00 p.m. the Risk Manager also confirmed there was no documentation of quality monitoring of these programs.
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on document review and staff interview it was determined the governing body failed to ensure quality review of the interventional cardiology program, the outpatient wound care center that includes hyperbaric services and the sleep study laboratory.

Findings include:

During review of the quality monitors for the interventional cardiology program it was noted that there was no tracking or trending of patient outcomes related to the service. The only data presented was meeting minutes from the STEMI committee. There was documentation the cases were reviewed, but no analysis of the findings and no reports generated to the quality committee, medical executive committee or governing body.

The Chief Executive Officer was interviewed on 4/25/13 at 12:35 p.m. and confirmed there was no monitoring of the program and patient outcomes beyond the discussions in the STEMI meetings. It was also confirmed there had been no review of the program for quality and safety by the governing body.

Review of the meeting minutes for the quality committee revealed that in addition to there being no review of the interventional cardiology program, there was also no review of the wound care center, hyperbaric therapy or the sleep laboratory. The Risk Manager also confirmed there was no documentation of quality monitoring of these programs.