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.

REGIONAL GENERAL HOSPITAL WILLISTON 125 SW 7TH ST WILLISTON, FL 32696 June 11, 2015
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, staff interview, and facility record review the facility failed to insure that a qualified Infection Disease Practitioner is employed, that the facility has a safe and effective Infection Control Program and the Governing Body provides oversite and is actively involved in the facility's Infection Control Program.

Findings

1. Reference A 0749 Based on facility record review and staff interview the facility failed to maintain a system for an effective Infection Control program.

2. Reference A 0756 Based on facility document review and staff interview the Governing Body failed to ensue that the facility has a functioning Infection Control Program that reports to Quality Assessment and Performance Improvement Committee.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on staff interviews, facility document review, and patient record review, the Governing
Body failed to establish an effective Quality Assurance Process Improvement and Infection Control programs to ensure patient safety; and to ensure the accountability of the Governing Body for oversite of the Quality Assurance Process Improvement and Infection Control programs. For these reasons, the Condition of Governing Body was found to be out of compliance. These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.

Findings:

Reference A 263 Based on interview and facility document review, it was confirmed the facility failed to establish or implement an effective Quality Assurance Process Improvement program throughout the facility, which is facility specific and encompassing all departments to include Infection Control, Patient Safety, Radiology, Nutrition Services, Laboratory and Pharmacy. The facility failed to enact programs to ensure patient safety, and to ensure the accountability and effectiveness of the Governing Body for the oversight of the all programs. For these reasons, the Condition of Quality Assurance was found to be out of compliance. These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.

Reference A 0747 Based on observation, staff interview, and facility record review the facility failed to insure that a qualified Infection Disease Practitioner is employed, that the facility has a safe and effective Infection Control Program and the Governing Body provides oversite and is actively involved in the facility's Infection Control Program.
VIOLATION: QAPI Tag No: A0263
Based on interview and facility document review, it was confirmed the facility failed to establish or implement an effective Quality Assurance Process Improvement program throughout the facility, which is facility specific and encompassing all departments to include Infection Control, Patient Safety, Radiology, Nutrition Services, Laboratory and Pharmacy. The facility failed to enact programs to ensure patient safety, and to ensure the accountability and effectiveness of the Governing Body for the oversight of the all programs. For these reasons, the Condition of Quality Assurance was found to be out of compliance. These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.

Findings:

Reference A0043: Based on interview, facility document review, it was confirmed the facility Governing Body failed to establish or implement an effective Quality Assurance Process Improvement program throughout the facility encompassing all departments to include Infection Control, Patient Safety, Radiology, Nutrition Services, Laboratory and Pharmacy and which is facility specific. The facility failed to enact programs to ensure patient safety, and to ensure the accountability and effectiveness of the Governing Body for the oversight of the all programs. For these reasons, the Condition of Governing Body was found to be out of compliance. These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.


1. A review of the facility documentation to include the current Quality Assurance Program and Occurrence Reports for the years 2014 and 2015 revealed no tracking or trending of the documented events to include the frequency or an evaluation of the cause of the identified concerns with process improvement programs established for all departments within the facility. An interview was conducted with the facility Risk Manager, Risk Manager Assistant Designee, Director of Nursing and COO / Administrator on 6/10/2015 at 9:15 AM. It was confirmed through review of the 2014 and 2015 reports the frequency and causes of events or analysis with programs initiated (Process Improvement) had not been evaluated for improvement activities. Facility specific departmental programs had not been established identifiying areas of needed improvement or when an area was identified, there was not plan established for the sustained improvement or evaluation of recurrences.

An interview was conducted with the Medical Director and Chief Operations Officer (COO)/Administrator on 6/11/2015 at 8:22 AM. The lack of a defined Quality Assurance Process Improvement program was discussed, taking into consideration those incidents or occurrences documented by the Risk Management Department within the facility since July 2014. The Medical Director stated he's been actively involved with the facility since March 2015. The concern was voiced that the departmental programs throughout the facility have not been reviewed since the date of the last survey (7/2014) and the data that was accumulated has not been developed into any performance based process improvement criteria for the facility. He confirmed his emphasis has been in the emergency room and ensuring the patient arriving in the unit has been cared for promptly by his team. It was clarified again that problems experienced in the overall facility have not been brought forward to the Quality Assurance Committee, broken down into cause and effect with plans established to minimize or eliminate their recurrence and improve overall quality of care for the patients. It was confirmed qualitative and quantitative data has not been generated by the departments for developing improvement programs.

2. An interview was conducted with the facility Administrator and Patient Safety Officer on 6/10/2015 at 8:53 AM. It was confirmed there had been one (1) Patient Safety Committee meeting during the past year which was conducted on 8/12/2014 subsequent to the last annual survey. A review of the Patient Safety Committee from that meeting confirmed there was no data collection or evaluation of the quality of patient safety measures used in the facility. There was no data collected or evaluated for the year through June 2015.

A follow-up interview was conducted on 6/10/2015 at 9:30 AM with the facility Risk Manager, Risk Manager Assistant Designee, Director of Nursing and COO/Administrator. The lack of evaluation of the Patient Safety Program to include the collection of data and analysis of the program was discussed and confirmed the program failed to actively collect safety data, analyze the safety issues within the facility and then develop plans to correct areas of concern.

No further information could be provided.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and facility document review, it was confirmed the facility failed to establish or implement an effective ongoing Quality Assurance Process Improvement program encompassing all departments with Quality Indicator criteria which is measurable and monitors the effectiveness and safety of services to include Infection Control, Patient Safety, Radiology, Nutrition Services, Laboratory and Pharmacy. The facility failed to enact programs to ensure patient safety, and to ensure the accountability and effectiveness of the Governing Body for the oversight of the all programs. These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.

Findings:

Governing Body minutes for the hospital were reviewed and failed to provide sufficient presentation of the Quality Assurance activities initiated by the departments of the facility with data collection, assimilation of the data process improvement plans implemented by the identified departments for years 2014 and 2015.

1. A review of the facility documentation to include the current Quality Assurance Program and Occurrence Reports for the years 2014 and 2015 revealed no tracking or trending of the documented events to include the frequency or an evaluation of the cause of the identified concerns with process improvement programs established for all departments within the facility. An interview was conducted with the facility Risk Manager, Risk Manager Assistant Designee, Director of Nursing and COO / Administrator on 6/10/2015 at 9:15 AM. It was confirmed through review of the 2014 and 2015 reports the frequency and causes of events or analysis with programs initiated (Process Improvement) had not been evaluated for improvement activities. Facility specific departmental programs had not been established identifying areas of needed improvement or when an area was identified, there was not plan established for the sustained improvement or evaluation of recurrences.

An interview was conducted with the Medical Director and Chief Operations Officer (COO)/Administrator on 6/11/2015 at 8:22 AM. The lack of a defined Quality Assurance Process Improvement program was discussed, taking into consideration those incidents or occurrences documented by the Risk Management Department within the facility since July 2014. The Medical Director stated he's been actively involved with the facility since March 2015. The concern was voiced that the departmental programs throughout the facility have not been reviewed since the date of the last survey (7/2014) and the data that was accumulated has not been developed into any performance based process improvement criteria for the facility. He confirmed his emphasis has been in the emergency room and ensuring the patient arriving in the unit has been cared for promptly by his team. It was clarified again that problems experienced in the overall facility have not been brought forward to the Quality Assurance Committee, broken down into cause and effect with plans established to minimize or eliminate their recurrence and improve overall quality of care for the patients. It was confirmed qualitative and quantitative data has not been generated by the departments for developing improvement programs.

2. An interview was conducted with the facility Administrator and Patient Safety Officer on 6/10/2015 at 8:53 AM. It was confirmed there had been one (1) Patient Safety Committee meeting during the past year which was conducted on 8/12/2014 subsequent to the last annual survey. A review of the Patient Safety Committee from that meeting confirmed there was no data collection or evaluation of the quality of patient safety measures used in the facility. There was no data collected or evaluated for the year through June 2015.

A follow-up interview was conducted on 6/10/2015 at 9:30 AM with the facility Risk Manager, Risk Manager Assistant Designee, Director of Nursing and COO/Administrator. The lack of evaluation of the Patient Safety Program to include the collection of data and analysis of the program was discussed and confirmed the program failed to actively collect safety data, analyze the safety issues within the facility and then develop plans to correct areas of concern.

No further information could be provided.

3. Reverence A 0756 Based on facility document review and staff interview the Governing Body failed to ensue that the facility has a functioning Infection Control Program that reports to Quality Assessment and Performance Improvement Committee
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview and facility document review, it was confirmed the facility failed to establish or implement an effective Quality Assurance Process Improvement program throughout the facility, which is the responsibility of the Governing Body and is facility specific and encompassing all departments to include Infection Control, Patient Safety, Radiology, Nutrition Services, Laboratory and Pharmacy. The facility failed to enact programs to ensure patient safety, and to ensure the accountability and effectiveness of the Governing Body for the oversight of the all programs. These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.

Findings:

Governing Body minutes for the hospital were reviewed and failed to provide sufficient presentation of the Quality Assurance activities initiated by the departments of the facility with data collection, assimilation of the data process improvement plans implemented by the identified departments for years 2014 and 2015.

1. A review of the facility documentation to include the current Quality Assurance Program and Occurrence Reports for the years 2014 and 2015 revealed no tracking or trending of the documented events to include the frequency or an evaluation of the cause of the identified concerns with process improvement programs established for all departments within the facility. An interview was conducted with the facility Risk Manager, Risk Manager Assistant Designee, Director of Nursing and COO / Administrator on 6/10/2015 at 9:15 AM. It was confirmed through review of the 2014 and 2015 reports the frequency and causes of events or analysis with programs initiated (Process Improvement) had not been evaluated for improvement activities. Facility specific departmental programs had not been established identifiying areas of needed improvement or when an area was identified, there was not plan established for the sustained improvement or evaluation of recurrences.

An interview was conducted with the Medical Director and Chief Operations Officer (COO)/Administrator on 6/11/2015 at 8:22 AM. The lack of a defined Quality Assurance Process Improvement program was discussed, taking into consideration those incidents or occurrences documented by the Risk Management Department within the facility since July 2014. The Medical Director stated he's been actively involved with the facility since March 2015. The concern was voiced that the departmental programs throughout the facility have not been reviewed since the date of the last survey (7/2014) and the data that was accumulated has not been developed into any performance based process improvement criteria for the facility. He confirmed his emphasis has been in the emergency room and ensuring the patient arriving in the unit has been cared for promptly by his team. It was clarified again that problems experienced in the overall facility have not been brought forward to the Quality Assurance Committee, broken down into cause and effect with plans established to minimize or eliminate their recurrence and improve overall quality of care for the patients. It was confirmed qualitative and quantitative data has not been generated by the departments for developing improvement programs.

2. An interview was conducted with the facility Administrator and Patient Safety Officer on 6/10/2015 at 8:53 AM. It was confirmed there had been one (1) Patient Safety Committee meeting during the past year which was conducted on 8/12/2014 subsequent to the last annual survey. A review of the Patient Safety Committee from that meeting confirmed there was no data collection or evaluation of the quality of patient safety measures used in the facility. There was no data collected or evaluated for the year through June 2015.

A follow-up interview was conducted on 6/10/2015 at 9:30 AM with the facility Risk Manager, Risk Manager Assistant Designee, Director of Nursing and COO/Administrator. The lack of evaluation of the Patient Safety Program to include the collection of data and analysis of the program was discussed and confirmed the program failed to actively collect safety data, analyze the safety issues within the facility and then develop plans to correct areas of concern.

No further information could be provided.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on facility record review and staff interview the facility failed to maintain a system for an effective Infection Control program


Findings:

1. Observation in the IV room across from the nursing station on 06/08/2015 at 10:34 AM of Nurse S revealed the nurse mixing IV medications for patient #1. The nurse was observed opening, (touching) in the sharps container with her right hand while disposing of empty medication vials. The nurse was observed without changing gloves and washing her hands, then injected medication in a IV bag with the contaminated glove on her right hand.

Observation on 06/08/2015 at 11:45 AM of the #1 revealed a IV pole next to his bed with a 1/2 full bag of NS that did not have any label that indicated the date and time when the normal saline was started. Observation of the IV tubing connected to the IV bag did not reveal any label indicating the date it started or when it was to be replaced. Interview with Nurse #1 revealed that they should be labeled.

Observation of Nurse #1 on 06/09/2015 at 8:17 AM the room of patient #9 revealed that the nurse washed her hands, placed on gloves and, then after wiping the IV injection port, inject a IV medication. After the medication was administered to the patient the nurse walked to the needle box container next to sink and opened it with her still gloved hand. The nurse returned to the patient and connected an IV bag mixed with Vancomycin to the resident's IV. The nurse was not observed changing her gloves until the tubing was connected to the IV and the IV pump was striated.

Review of the facility Policy and Procedure titled RECOMMENDATIONS FOR HAND HYGIENE/IC P&P MANUAL revealed under on page 1 of 5 Indication for Handwashing and Hand Antiseptics to Decontaminate hands after contact with inanimate objects, (including medical equipment), in the immediate vicinity of the patient.

2. Review of the Quality Assurance Performance Improvement meeting minutes for January 2015 revealed the results on Infection Control study on hand washing completed in December 2014. The study revealed an 85% non-compliance rate for hand hygiene by the hospital staff. The Quality Assurance Performance Improvement meeting minutes for January 2015 revealed that a Plan of Correction was approved that included providing the staff with educational hand-outs, requiring the staff to pass a post test and that on the spot correctional counseling will be performed. The Plan of Correction included that Hand Hygiene will be continued to be monitored.

Review of the quality Assurance Performance Committee after January 2015 did not reveal any follow -up to the Handwashing study.

3. Review of the quality Assurance Performance Committee after January 2015 did not reveal that any Infection Control reporting was done or that Infection Control was on the agenda.

4. Review of the Infection Control data collected monthly in 2015 was not reported to any committees including the Governing Body.

Interview with the VPO/CCO on 06/10/2015 at 10:00 AM revealed that the Infection Control Nurse had resigned the last Friday and that currently they are looking for a replacement. He stated that the Nurse replaced the last Infection Control Nurse that had resigned last March.