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.

WILLIAM R SHARPE, JR HOSPITAL 936 SHARPE HOSPITAL ROAD WESTON, WV 26452 June 24, 2015
VIOLATION: PATIENT SAFETY Tag No: A0286
A. Based on document review and staff interview it was determined the hospital Quality Improvement Program failed to oversee the analysis of the causes of medication errors and implementation of preventive actions and mechanisms, including feedback and education, throughout the hospital. This failure negatively impacts the quality of care for all patients.

Findings include:

The hospital's Performance Improvement Plan and the Continuous Quality Improvement (CQI) meeting minutes for 1/27/15, 2/24/15, 3/23/15 and 5/5/15 were provided and reviewed.

The hospital's Performance Improvement Plan states, in part: "The priority focus areas are... Medication Management... The data collection is aggregated and analyzed to determine any changes or improvement that needs to be made... Undesirable trends in performance may result in further intensive analysis, particularly when it is related to patient safety."

Review of the CQI's Meeting Minutes revealed no mention of medication errors or what preventive actions and mechanisms are being implemented to address and reduce errors.

Review of the Pharmacy and Therapeutics quarterly reports presented at the January and May meetings revealed medication errors were listed in both reports but no improvement activities were referenced.

Review of the Pharmacy and Therapeutics Meeting Minutes for 1/13/15 revealed the Medication Error Comparison Report for 2013 and 2014 was distributed and reviewed. The minutes did not reflect any discussion, assessment of the report, or if there were improvements or trends to address.

Review of the Medication Error Comparison revealed the medication error number had increased by more than fifty (50) percent. There was no mention of medication error action plans found in any of the CQI Meeting Minutes.

The Medication Safety Committee Minutes for 6/4/15, 5/7/15, 4/16/15, 2/5/15 and 1/8/15 were also reviewed. These minutes included a listing of medication errors, but lacked improvement activities and/or assessment of improvement activities.

The above listed information was reviewed and discussed with the CQI/Compliance Director on 6/24/15 at 11:30 a.m. She acknowledged the minutes reviewed did not reflect activities to measure, analyze or track medication errors. The resulting performance activities were implemented to prevent recurrence and measure the efforts to improve medication safety.

B. Based on document review and staff interview it was determined the hospital failed to ensure the maintenance of a reporting system to measure, track and analyze all adverse events. This failure was noted with one (1) of one (1) security log reports reviewed for medications keys which were found and turned into the security department. This failure creates a potential for an adverse impact on the quality of care provided to all patients.

Findings include:

1. Review of hospital documents related to an ongoing investigation revealed a copy of a 6/7/15 security log indicating a set of keys for the C2 Unit medication room door and a medication cart were found on the C1 Unit and turned into security. Security then returned the keys to the nursing department. It was determined the keys came out of the Nursing Clinical Coordinator's (NCC) office.

A request was made to the Quality Department for the investigation reports pertaining to this event. The Quality Department was unable to locate the report at the time of this survey.

Review of the NCC Shift Reports and NCC Weekly Summaries for the 6/7/15 timeframe revealed there was no mention of the medication room keys being found or turned in to security.

An interview was conducted with the Chief Nursing Officer (CNO) on 6/23/15 at 2:20 p.m. She stated the NCC did not inform her about this incident. She further stated she was made aware of the event on 6/16/15 but at no time did she realize the keys recovered belonged to the medication room.

The CNO acknowledged this was an unusual incident with potentially serious consequences and should have been reported and documented immediately for timely follow-up and analysis. She confirmed the incident was not reported or documented immediately, nor was the staff involved spoken to in a timely manner.

2. Review of the policy titled, "Incident Reporting and Review Policy", with an effective date of 1/15/15, states, in part: "An incident form must be forwarded to the Quality Department as soon as possible... reporting and reviewing of incidents/accidents provides hospital leaders with valuable information for Performance Improvement activities. Review of patterns and trends of specific types of incidents serve to identify contributing factors/conditions... thus enhancing the safety of patients, employees, and visitors. The hospital encourages a culture of open communication in order to support accurate, timely reporting of errors, incidents and near misses... Employees are responsible for completing an Incident Report form as soon as possible, but ideally at the time they become aware of an incident."

3. The Compliance Officer confirmed on 6/25/15 at 9:00 a.m. no incident reports or any other report forms were completed or filed regarding this incident.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on document review and staff interview it was determined Nursing Services failed to ensure an adequate number of licensed Registered Nurses (RN) is maintained on the night shift to ensure the immediate availability of a RN for bedside care of patients. This failure adversely affects the care and condition of all patients.

Findings include:

1. An interview was conducted with Nurse Clinical Coordinator (NCC) #2 on 6/17/15 at 1:15 p.m. The Night Shift NCC staffing sheet for 6/6/15 was reviewed at that time. The staffing sheet reflected there was only one (1) RN on duty for units N-1, N-2, E-1 and C-2.

The NCC was asked how lunch breaks are provided on units which have only one (1) RN on duty. She stated the RN notifies another Unit Nurse that she is leaving. The RN leaves her keys with the Unit Nurse while gone on break. She confirmed that the covering RN does not leave her unit to cover the unit while the RN is on her lunch break, leaving the unit without RN coverage. When asked if the NCC could cover for breaks she stated they are too busy and routinely do not cover breaks.

2. Review of the Night Shift NCC staff sheets for 6/1/15 to 6/24/15 revealed most units are staffed with only one (1) RN. There are six (6) patient units in the hospital. On three (3) dates in June, four (4) units were staffed with only one (1) RN. On ten (10) dates in June, five (5) units were staffed with one (1) RN. On eleven (11) dates in June all six (6) units were staffed with one (1) RN.

3. An interview was conducted with the Chief Nursing Officer (CNO) on 6/23/15 at 2:00 p.m. The policy titled, "Nursing Department Staff and Acuity", with an effective date of 1998 was reviewed. The policy states, in part: "RN (Registered Nurse) staff is to include at least one (1) scheduled RN per shift per twenty-five (25) to thirty (30) bed capacity patient care unit..." Further review of the policy revealed there were no minimum RN staffing levels established for the night shift. The CNO stated the minimum requirement for night shift is one (1) RN. The RN leaves the unit for a break, sometimes leaving the hospital grounds, without being physically replaced by another RN to cover her duties while she is on break. She confirmed the RN does call and leaves her keys with a neighboring unit while she is gone. The CNO acknowledged the hospital was not currently meeting the requirements for having the physical presence of a RN on each unit at all times. She stated she would work to correct this issue by increasing staff on the nightshift.
VIOLATION: HOSPITAL PROCEDURES Tag No: A0410
Based on document review and staff interview it was determined the nurse failed to follow the hospital's procedures for reporting a controlled drug discrepancy. This was identified in one (1) of one (1) records reviewed with an identified drug discrepancy for Patient #1. This failure creates the potential for missed opportunities to implement necessary corrections and/or improvements.

Findings include:

1. Interview with the Chief Nursing Officer (CNO) on 6/22/15 at 9:45 a.m. revealed hospital staff reported a narcotic discrepancy approximately one (1) week to ten (10) days prior to this survey. Review of the controlled drug count record for unit C-2 on 6/13/15 revealed an unexplained discrepancy in the count for oxycodone solution twenty (20) milligrams/milliliters (mg/ml) for Patient #1.

2. Review of the policy titled, "Controlled Medication Discrepancy", with an effective date of 2/92, revealed, in part: "The Nurse who discovered the discrepancy will immediately complete the Narcotic Discrepancy Report and forward it to the Nurse Clinical Coordinator (NCC) on duty."

Review of the policy titled, "Ordering and Obtaining Controlled Medications", with an effective date of March 1991, revealed, in part: "Count sheets will be accurate and complete. If count sheets are incomplete or show a count discrepancy a Medication Discrepancy report form must be filled out immediately."

3. Review of the 6/13/15 Unit Controlled Drug Count Record for unit C2 revealed a discrepancy recorded for the 7:30 a.m. count of oxycodone solution twenty (20) mg/ml.

4. On 6/22/15 the Narcotic Discrepancy Report for the 6/16/15 discrepancy was requested. The Compliance Director confirmed on 6/22/15 at 1:00 p.m. no Discrepancy Report was completed for the discrepancy.

On 6/23/15 the Pharmacy Director stated there should have been a Narcotic Discrepancy Report completed for the 6/13/15 discrepancy. The Pharmacy Director acknowledged a Narcotic Discrepancy Report was not completed for 6/13/15 narcotic discrepancy.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
A. Based on medical record review, document review and staff interview it was determined drug administration errors were not documented or reported to the attending physician as required in ten (10) out of ten (10) records reviewed, with actual medication errors (Patient #1, Patient #3, Patient #4, Patient #5, Patient #6, Patient #9, Patient #10, Patient #12, Patient #13 and Patient #14). This failure creates the potential for an adverse impact on the care and condition of all patients who experience medication errors.

Findings include:

1. Review of a Medication Error Report dated 4/20/15 revealed an error occurred on 4/13/15 in the administration of medication for Patient #1. The sections of the form for the patient vital signs, physician notification and physician response were not completed. Review of Patient #1's medical record revealed no mention of what occurred or what was reported to the physician.

2. Review of a Medication Error Report dated 6/18/15 revealed an error occurred in the administration of medication for Patient #3. Review of Patient #3's medical record revealed no mention of what occurred or what was reported to the physician.

3. Review of a Medication Error Report dated 5/11/15 revealed an error occurred in the administration of medication for Patient #4. Review of Patient #4's medical record revealed no mention of what occurred or what was reported to the physician.

4. Review of a Medication Error Report dated 5/1/15 revealed an error occurred on 4/30/15 in the administration of medication for Patient #5. Review of Patient #5's medical record revealed no mention of what occurred or what was reported to the physician.

5. Review of a Medication Error Report dated 5/10/15 revealed an error occurred on 5/3/15 in the administration of medication for Patient #6. Review of Patient #6's medical record revealed no mention of what occurred or what was reported to the physician.

6. Review of a Medication Error Report dated 11/19/14 revealed an error occurred on 10/24/14 in the administration of medication for Patient #9. Review of the Medication Error form revealed the physician notification and physician response sections were not completed. Review of Patient #9's medical record revealed no mention of what occurred or what was reported to the physician.

7. Review of a Medication Error Report dated 9/11/14 revealed an error occurred in the administration of medication for Patient #10. The sections of the form for the patient's vital signs, physician notification and physician response were not completed. Review of Patient #10's medical record revealed no mention of what occurred or what was reported to the physician.

8. Review of a Medication Error Report dated 8/19/14 revealed an error occurred in the administration of medication for Patient #12. The sections of the report for the patient's vital signs, physician notification and physician response were not completed. Review of Patient #12's medical record revealed no mention what occurred or what was reported to the physician.

9. Review of a Medication Error Report dated 9/16/14 revealed an error occurred on 9/15/14 in the administration of medications for Patient #13. The sections of the report for the patient's vital signs, physician notification and physician response were not completed. Review of Patient #13's medical record revealed no mention of what occurred or what was reported to the physician.

10. Review of a Medication Error Report dated 2/25/15 revealed an error occurred on 2/7/15 in the administration of medication for Patient #14. Review of the sections for physician notification and physician response revealed they were not completed. Review of Patient #14's medical record revealed no mention of what occurred or what was reported to the physician.

The policy titled, "Medication Errors", with an effective date of 10/1/2000, was provided for review. It states, in part: "If an actual medication error has occurred, the RN (Registered Nurse) responsible for the patient's care should first notify the Physician or the Physician's Assistant. All doses of medication should be accurately documented in the patient's progress notes."

The above mentioned documents and records were reviewed with the Compliance Director on 6/24/15 at 11:00 a.m. and she agreed with the findings.

B. Based on document review and staff interview it was determined the Medication Safety Committee Assessment portion of the Drug Administration Error Reports were not completed for quality review as required per policy for eleven (11) out of fourteen (14) medication error reports reviewed. This included both actual and potential medication error reports and involved Patient #1, Patient #4, Patient #5, Patient #6, Patient #7, Patient #8, Patient #9, Patient #10, Patient #12, Patient #13 and Patient #14. This creates the potential for an adverse impact on the quality of care for all patients receiving medications.

1. The policy titled, "Medication Errors", with an effective date of 10/1/2000, was provided for review. The policy states, in part: "The Medication Error Interdisciplinary Team will complete the Medication Error Assessment, then further investigate the Medication Error if warranted. This investigation will include any systems problems that may have contributed to the event... All Medication Error reports will be forwarded to the Medication Error Interdisciplinary Team within seventy-two (72) hours... summary and analysis of the Medication Errors will be reported monthly to the Director of Nursing, the Clinical Director, the Pharmacy Director, the hospital's Joint Commission Measures Initiative Coordinator and quarterly to the Pharmacy and Therapeutics Committee."

Review of samples of the Medication Error report, last updated on 2/11, for the past year revealed the front page of the report noted: "To be completed by the person discovering the event." The back page, titled "Medication Error Safety Committee Assessment", noted: "To be completed by the Medication Safety Committee." Review of the sample of fourteen (14) Medication Error reports revealed the back page was not completed on eleven (11). This back page includes the section for event assessment and course of action.

2. The back page of the 4/20/15 Medication Error Report for Patient #1 was not completed.

3. The back page of the 5/11/15 Medication Error Report for Patient #4 was not completed.

4. The back page of the 5/1/15 Medication Error Report for Patient #5 was not completed.

5. The back page of the 5/10/15 Medication Error Report for Patient #6 was not completed.

6. The back page of the 4/26/15 Medication Error Report for Patient #7 was not completed.

7. The back page of the 4/25/15 Medication Error Report for Patient #8 was not completed.

8. The back page of the 11/19/14 Medication Error Report for Patient #9 was not completed.

9. The back page of the 9/11/14 Medication Error Report for Patient #10 was partially completed.

10. The back page of the 8/19/14 Medication Error Report for Patient #12 was partially completed.

11. The back page of the 9/16/14 Medication Error Report for Patient #13 was not completed.

12. The back page of the 2/25/15 Medication Error Report for Patient #14 was not completed.

Review of the Medication Safety Committee minutes and Pharmacy and Therapeutics (P&T) Committee minutes revealed a summary of complaints were listed. No investigation with contributory factors or other system factors were identified. There was no analysis of the event with an action plan documented.

The Medication Error Reports were reviewed and discussed with the Pharmacy Director on 6/23/15 at 10:40 a.m. He explained the Medication Safety Committee and the P&T Committee are reviewing medication errors and were responsible for quality measures in addition to the CQI Committee. He acknowledged documentation of the medication error review process had been better in the past. He stated the number of errors was low and there were few steps left that could be taken to reduce or improve the process. He acknowledged the documentation was lacking. The Director stated he took responsibility for the incomplete assessments of the medication errors and stated he would take steps to ensure completion in the future.