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Based on interview, record review, and policy and procedure review, the facility failed to take action aimed at performance improvement.

Findings:

Record review of the Patient Safety Committee Minutes, dated 10/11/2016, showed Topic: Profile Overrides. Discussion/Findings: There was discussion about several of the overrides. The clinical educator discussed the variances with staff involved. There is an action plan in place. The committee agreed that medication pass audits need to be conducted incorporating the profile override process. The committee also recommended that Pharmacy Service conduct live in-service education for nurses on Look Alike-Sound-Alike medications. It was also recommended that nurses receive education on their responsibility as it related to signing as a witness. Action Recommendations: Facilitate medication pass audits and look Alike-Sound Alike education with Pharmacy Service. In-service education on signing as a witness. Report findings to committee. Follow Up: Hospital Educator.

Record review of the Patient Safety Committee Minutes showed dated: 11/8/2016 Old Business: Medication Pass Audits. Discussion/Findings: Has not been implemented. There was a discussion about the need to begin audits and the importance of having pharmacy involved in the process. The committee felt that 2 patients per week was reasonable and would not be a burden on pharmacy staff. Action Recommendations: Develop audit tool. Pharmacist to conduct 2 med pass audits per weeks. Report findings to PSC (Patient Safety Committee). Follow Up: Educator, Pharmacist. Look Alike-Sound Alike: Has not been implemented. There was a discussion about the need to provide short in service training and not rely on passive means of educating, i.e., signage. Committee members still agree that pharmacy involvement is appropriate and necessary. Action Recommendations: Provide update to PSC. Follow Up: Pharmacist. Witnessing Medications: Has not been implemented. Witnessing medications will be part of the med pass audit process. Action Recommendations: Refer to recommendations under "medication pass audits". Follow Up: Refer to recommendations under "medication pass audits".

During an interview on 3/6/2017 at 1:36 PM with the Director of Quality/Risk (DQR), she stated there was no meeting in December 2016.

Record review of the Patient Safety Committee Minutes showed dated: 1/10/2017 Old Business: Medication Pass Audits: Sample audit forms were provided to pharmacy. The audits have not started. There was a discussion about potential barriers to implementation. None were identified. Committee recommending that audits begin in January 2017. Action Recommendations: Hospital Educator to follow-up with pharmacists and provide education in the medication pass audit process. Follow Up: Hospital Educator. Look Alike-Sound Alike: The Automated Dispensing System (ADS-Pyxis) has been programmed to display a "Sound Alike-Look Alike" alert. This requires the nurse to acknowledge the transaction and serves as documentation. Action Recommendations: No additional follow up. Monitor for patterns/concerns. Follow Up: N/A (Not Applicable). Witnessing Medications: Pending update. This is part of the medication pass audit. Action Recommendations: Monitor through med pass audits and report trends/pattern. Follow Up: N/A.

Record review of the Patient Safety Committee Minutes showed dated: 2/14/2017 Old Business: Medication Pass Audits: The interim pharmacy director conducted a few medication pass rounds. There were no significant issues identified. Action Recommendations: continue with audits. Report findings to committee. Follow Up: Hospital Educator.

Record review of the Medication Pass Audit Tool, dated 1/27/2017, showed there were two medication audits completed for the period of 10/2016 through 1/27/2017. There was no documentation on the audits regarding Witnessing Medications.

During an interview on 3/6/2017 at 1:26 PM with the DQR, she stated, regarding the medication pass audit, this is something we should do to ensure appropriate steps are being taken with medication pass in general. While we are at it, we should add the profile override piece. This was something I stated should be done, the audits for medication pass. It wasn't being done so in October 2016 I said it should be and as part of the medication pass audits we should also do the audit for the override of the medications for administration. When asked for the live in-service regarding Look Alike, Sound Alike medications sign in sheet which was recommended in 10/2016 and 11/2016, the Risk Manger stated, "In 1/2017 it was decided the automatic dispensing system was programmed to give an alert." When asked if the recommendation was for a live in-service the DQR stated, "Yes. There is no evidence of training having been done. That is my official statement."

During an interview on 3/6/2017 at 1:58 PM with the Clinical Staff Educator (CSE), when asked for the two medication pass audits that were to be done weekly starting in 10/2016, the Staff Educator stated the pharmacist was responsible to get it done. When asked for documentation of the live in-service for Look Alike, Sound Alike medication training for the nursing staff, the CSE stated the training was not provided.

During an interview on 3/6/2017 at 2:05 PM with Chief Clinical Operations (CCO), when asked about the medication pass audits and the live in-service training for Sound Alike, Look Alike for the nursing staff the CCO stated, "The simple answer is that we didn't get it done."

Record review of the 2017 Promise Hospital Of Florida At The Villages Strategic Quality Plan showed on page 3 - We are committed to consistently delivering the highest quality of care through disciplined performance and regular re-examination of needs and desires of our patients and payor standards. We measure the effectiveness of our efforts by tracking processes that are critical to our organizational success including provision of clinical services and related billing for services provided. Analysis of performance within our Key Success Factors leads to new opportunities for improvement and are tightly integrated with our quality strategy and vision. Use of the Balanced Score Card process ensures visibility and communicates progress of key metrics. Benchmarks, targets, and minimum thresholds are developed based on performance and improvement goals designed to reduce variation, drive out waste, and improve outcomes. Trends and patterns are monitored and statistical process control (SPC) stools utilized when possible to ensure appropriate response to outliers. Page 10 - Becoming Process Driven: To achieve Operational Excellence, the leadership team must ensure that processes and systems are well-designed and capable of achieving the desired outcomes. Moving from being strictly results oriented to becoming more process driven requires a leadership-led shift to process management utilizing statistical thinking and methods. Since you do not do the result, but you execute the Process, focusing on refining, controlling and improving the process enables you to stabilize predict and control the result.

Based on observation and interview, it was confirmed that the facility failed to ensure the confidentiality of patients' medical record information and failed to ensure that unauthorized individuals cannot gain access to or alter these patient records.

Findings:

During a tour of the facility with the Chief Executive Officer, Risk Manager and the Chief Clinical Officer on 3/8/2017 at 11:18 AM revealed 11 patients' medical records are on clipboards. The clipboards front page has a blank paper that serves as the cover of the medical records. The clipboards are hanging on a wall in the medical surgical hallway. There is a nurse's work desk in front of the clipboards. Review of the documents on the clipboard revealed the patients' identifier, vital signs and other medical documentation. The medical records on a clipboard are aligned on the wall. The records were not secured, and are easily accessed by unauthorized personnel, visitors and other patients. One female visitor was observed walking by the hallway where the clipboards were hanging on the wall. At 11:30 AM some environmental staff and other personnel who have easy access and potentially could take, tamper or alter these medical records, were observed in the hallway where clipboards were hanging on the wall.

During an interview with the Chief Executive Officer on 3/8/2017 at 11:44 AM, it was confirmed that the patients' medical records are on these clipboards and did not occur to him until surveyor addressed the concern of lack of confidentiality.

During an interview with the Health Information Management (HIM) Coordinator/Coder on 3/7/2017 at 8:52 AM, it was stated that all of our medical records are secured in a locked office with keypad entry for authorized personnel only. Confidentiality of the records on the floor are behind the nurse's station with last name and first initial only. The physician may take the records to the dictating room. The physicians will take the medical records in a closed-door room and dictate. Physician then brings them back to the nurse's station. The Case Managers has a system of signing them out by putting a sign on the slot and keeps the records for about an hour for review.

During an interview with the Risk Manager on 3/8/2017 at 11:46 AM, it was stated the facility does not have a specific policy on medical records management on the nursing floors.

Based on observation, interview and facility policy review, it was confirmed that the facility failed to ensure that outdated, mislabeled, or otherwise unusable drugs and biological's were not available for patient use.

Findings:

A tour of the operating room was conducted on 3/6/2017 from 2:30 PM to 2:50 PM with the Surgical Services Coordinator, the facility's Risk Manager and a Registered Pharmacist (RPH). The RPH unlocked the anesthesia cart. Observation of the anesthesia cart revealed 1 out of 4 vials of .9% normal saline- 30 milliliter (ml) had an expiration date of 12/2016. The RPH removed the vial from the cart.

During an interview with the RPH on 3/6/2017 at 2:52 PM, when asked who is responsible for checking the anesthesia cart for expiration dates, RPH replied, we in the pharmacy department.

During an interview with another RPH, staff pharmacist, on 3/8/2017 at 9:24 AM, it was stated we review through Pyxis what has been used, we will go down and replace each item that has been used that day. Whenever we replace any medication in the medication Pyxis cart, the pharmacy technician checks for expiration dates.

Review of the General Storage Policy provided by the Risk manager on 3/8/2017 at 10:12 AM, which has an effective date of 5/2014 and reviewed on 6/2016, showed on Page 1 of 1 of the policy reads: Drugs and devices shall be stored to ensure their stability and integrity.

Review of Expired or Destroyed Medications policy and procedure provided by the Risk Manager on 3/8/2017 at 12:32 PM revealed an effective date of 5/2014, reviewed and revised on 6/2016, and showed on Page 1 of 2 of the policy reads:
Purpose: To eliminate expired medications from active stock so that they can no longer be dispensed or utilized.
Policy: The pharmacy will assure that outdated or unusable medications are removed from active stock (within pharmacy, floor stock, and automated dispensing machines) through a monthly audit conducted by the pharmacy staff. All unused or expired medication will be returned to pharmacy for proper processing.