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.

ST CLOUD HOSPITAL 1406 6TH AVE NORTH SAINT CLOUD, MN 56303 April 7, 2011
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observations, interviews, and documentation review, the hospital failed to have a system, including policies and procedures, in place to actively identify and minimize potential and actual continued drug diversion. Although the hospital identified two significant cases of drug diversion with two separate employees in the last six months, there continues to be a high risk for continued drug diversion. This failure places all patients receiving narcotics at risk of their narcotics being diverted for employee use. The Condition of Participation for Pharmaceutical Services is out of compliance. See documentation at tag 42 CFR 48.25(a)(3)/A 494.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, interviews, and documentation review, the hospital failed to have a system in place to actively identify and minimize potential and actual continued drug diversion and failed to keep current and accurate records to trace the movement and distribution of schedule II, III, IV, and V narcotic medications. Although the hospital identified two significant cases of drug diversion with two separate employees (Employees (E)/nurse and (F)/nurse) in the last six months, there continues to be a high risk for continued drug diversion. This failure places all patients receiving narcotics at risk of their narcotics being diverted for employee use.
Findings include:

Observations on various stations within the hospital on [DATE] and interviews with employee (B)/pharmacy staff on 04/07/2011 at 8:45 a.m. and employee (C)/pharmacy staff on 04/07/11 at 11:10 a.m. revealed that the hospital's Pharmacy utilizes Omnicell carts, which is a medication automated distribution unit that is secured with a logon and password. This medication unit stores medications for patient use, including schedule II, III, IV, and V narcotic medications. In addition, a set of keys are kept in the Omnicell carts to another double locked cupboard that stores the hospital's patient controlled anesthesia (PCA) pumps (a patient controlled intravenous pump) and Hydromorphone (a schedule II medication used for the PCA pump). Each time a nurse removes a medication from the Omnicell, the nurse must enter their log in and password. According to interviews with employees (B) and (C), the Omnicell system does have the ability to create a "Dispensing Practices Report," which is a computerized report that compares dispensing practices of employees for medications removed from Omnicell.

Documentation of the Omnicell "Dispensing Practices Report" for Schedule II, III, IV, and V narcotic medications from 01/28/2010 through 7/28/2010 was reviewed and revealed that over the period of six months, employee (E)/nurse removed significantly more controlled medications than her peers. The report indicated that on 117 transaction days (the number of days in which the Omnicell was utilized), employee (E) removed 1,582 total controlled medication doses from the Omnicell. In addition, according to an Omnicell "Dispensing Practices Report" for the medication Oxycodone (a schedule II narcotic medication which is considered to have a strong potential for abuse or addiction) from 01/28/2010 through 7/28/2010, on 117 transaction days employee (E) removed 825 total doses from the Omnicell, a number significantly higher than her peers.

Employee (C) was interviewed on 04/07/11 at 11:10 a.m. and indicated that in July of 2010 he completed a routine review of the Omnicell "Dispensing Practices Report" for Schedule II, III, IV, and V narcotic medications for the prior six months and noticed excessive doses of controlled medications, especially Oxycodone, being removed by employee (E)/nurse. He immediately notified employee (D)/administrative nurse for further investigation. When asked why this was not identified earlier, he stated he did not know and indicated that the hospital did not have a formal process in place for identifying potential drug diversion other than looking at the Omnicell "Dispensing Practices Report" or if a concern is brought to their attention by staff. When asked when he last reviewed the report prior to July 2011, he indicated that it should have been completed in the prior three months, but could not recall the exact date or month.

Employee (D) was interviewed on 4/7/2011 at 10:15 a.m. and indicated that after she was notified regarding the increased access to medications from the Omnicell by employee (E), she compared a sample of medications being taken out of Omnicell for specific patients by employee (E) to the specific patients' medication administration records (MARs), which are documented in EPIC (the hospital's electronic medical record). Employee (D) identified that on multiple occasions employee (E) would remove four to six doses of a controlled medication out of Omnicell and document in EPIC that she administered two doses to the patient. When asked regarding the security of controlled medications, she indicated that the medications are kept in a secured area and are restricted by a code and the hospital reviews the Omnicell "Dispensing Practices Report" periodically. She indicated that she was not aware of any other security measures for the controlled medications.

According to the interview with employee (C) on 04/07/11 at 11:10 a.m. EPIC and Omnicell are two different computerized systems and do not share information. Therefore, the only way to identify discrepancies between doses of medication being removed from Omnicell and doses of medication being recorded in each patients MAR is to go through the separate systems manually and compare the Omnicell report to each individual patient's MAR in EPIC.

According the interview with employee (D) on 4/7/2011 at 10:15 a.m. and documentation review of the hospital's identified drug diversions from April 2010 through April 2011, following the drug diversion that was identified with employee (E) in July 2010, a second case of employee drug diversion was identified in April of 2011.

Employees (C) and (D) indicated that after a concern was raised regarding possible employee drug diversion in the beginning of April 2011 in relation to PCA pumps/Hydromorphone, an Omnicell "Dispensing Practices Report" for the narcotic keys kept in the Omnicell for the PCA pumps/Hydromorphone was generated. The employees indicated that prior to April 2011, the hospital did not review the key report because no concerns had been raised in the past. When the report was reviewed, it was revealed that employee (F)/nurse had accessed the keys significantly more than his peers, including accessing the keys on numerous occasions when he was not scheduled to provide patient care. Employee (F) was confronted regarding the Omnicell "Dispensing Practices Report," and he confessed to diverting Hydromorphone.

Documentation of the Omnicell "Dispensing Practices Report" for removal of the narcotic keys from 06/01/2010 through 2/28/2011 was reviewed and revealed that on 163 transaction days employee (F) removed the keys 246 times.

When asked regarding the hospital's system for decreasing the risk of drug diversion and ensuring the security of controlled medications, employees (B), (C), (D), (G)/administrative staff, and (F)/administrative staff all indicated during the site investigation between 04/06/2011 and 04/07/2011 that the current system is to review the Omnicell "Dispensing Practices Report" at least every three months. When asked if there was a system to identify a concern regarding the security of medications or drug diversion between the three months when reports are reviewed, they all reiterated that the current system is to review the reports. No other system was in place unless a concern was brought to their attention.