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CITY OF HOPE HELFORD CLINICAL RESEARCH HOSPITAL 1500 E DUARTE ROAD DUARTE, CA May 4, 2017
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on interview and document review, the hospital failed to ensure policies and procedures for controlled substance (CS - medications with the potential for abuse) accountability were implemented when there were no Pharmacy Services processes in place to ensure control of the issuance of temporary access by the charge nurses for the automated (computerized) dispensing cabinets (ADCs - password-accessible machines that store and dispense medications).

This failure resulted in CS theft, the potential for future CS theft, and the potential for patient harm due to impaired (when a person becomes physically and mentally affected from drugs) staff.

Findings:

On 5/1/17 at 10:55 a.m., during an interview, the Senior Director of Pharmacy (DOP) stated the hospital investigated "inappropriate withdrawals [drug diversion]" from the facility's ADC system by Nurse A, who was a traveler (a licensed nurse assigned to work in the hospital for a limited time period), and Nurse B, who was a registry (agency) nurse. Nurse A and Nurse B were not available for interview.

On 5/2/17 at 10:24 a.m., during an interview, the DOP stated he started investigating Nurse A and Nurse B on 1/19/17. During the drug diversion investigation, reports generated by the DOP indicated Nurse A had 4 different "User Names". The report indicated that Nurse A had a permanent User ID to access the ADC. The DOP stated he noticed Nurse A had three aliases (creation of false names) which were indicated by alterations (misspellings) of Nurse A's first and last name. The DOP stated the system would see Nurse A's four "User Names" as different people.

On 5/3/17 at 9:01 a.m., during an interview with the DOP and Unit Nurse Manager 1, they acknowledged Nurse A's travel nurse agreement indicated assignment start date as 10/25/16 and assignment end date as 1/21/17. The DOP and Unit Nurse Manager 1 acknowledged the first identified drug diversion occurred on 11/4/16. The time duration calculated between the first identified drug diversion (11/4/17) and start of investigation (1/19/17) was 76 days or 2 months and 15 days (2.5 months). The Unit Nurse Manager 1 identified Charge Nurse 2 and Charge Nurse 3 as the hospital staff who had the ability to give Nurse A temporary access to the facility's ADC system.

On 5/3/17 at 9:20 a.m., during an interview, the DOP stated all charge nurses have the ability to issue temporary access. The DOP acknowledged he did not have a method to determine or monitor when temporary access to the facility's ADC system was given out.

On 5/3/17 at 9:49 a.m., during an interview, the Unit Nurse Manager 1 acknowledged the education to prevent the creation of future aliases was informally reviewed with Charge Nurse 2 and Charge Nurse 3. She stated the process for charge nurses issuing temporary access to the facility's ADCs was for the charge nurse to type in the nurse's name instead of the nurse typing in their own names themselves into the facility's ADC system. The Unit Manager 1 was requested to provide documentation of the education of the two nurses but the facility did not provide the requested documentation by the end of survey.

On 5/3/17 at 10:22 a.m., during an interview, Charge Nurse 2 acknowledged she had the ability to issue out temporary access to the facility's ADC system. Charge Nurse 2 stated she did not remember issuing Nurse A temporary access. She stated there may have been one time she allowed a licensed nurse to enter in their own name into the facility's ADC system computer screen instead of entering the nurse requestor's name herself. She stated she had no record which licensed nurses she had issued temporary access.

On 5/3/17 at 10:56 a.m., during an interview and concurrent document review, the DOP acknowledged the DEA Form 106 titled, "Report of Theft or Loss of Controlled Substances", indicated the date of theft/loss as 1/19/17. The type of theft/loss indicated was "Employee Pilferage (theft)". The list of the controlled substances that were lost or stolen: ketamine (pain medication) 100 mg/ml (quantity lost/stolen: 115 mL (abbreviation for milliliters - a unit of measurement)), hydromorphone (pain medication) 2 mg/ml (quantity lost/stolen: 1 mL), and meperidine (pain medication) 25 mg/ml (quantity lost/stolen: 2 mL).

On 5/3/17 at 2:24 p.m., during an interview, Charge Nurse 3 acknowledged she had issued temporary access to the facility's ADC system before. Charge 3 stated she did not remember issuing Nurse A temporary access. She stated she had no record which licensed nurses she had issued temporary access.

On 5/4/17 at 8:37 a.m., during an interview, the DOP acknowledged that a charge nurse could give themselves temporary access to the facility's ADC system under an alias similar to Nurse A.

On 5/4/17 at 9:04 a.m., during an interview and concurrent document review with the DOP and the Director of Risk Management, they acknowledged the number of facility charge nurses was at least 35. This indicated 2 of 35 charge nurses (5.7%) were educated on the process prior to survey.

On 5/4/17 at 9:40 a.m., during an interview, upon inquiry on how Nurse A was able to alter the spelling of his name, the DOP acknowledged the hospital was not certain on how the aliases were created since the charge nurses did not remember but it appeared hospital staff let Nurse A type in his altered name into the facility's ADC system for temporary access.

On 5/4/17 at 10:51 a.m., during an interview and concurrent review of the facility policy on "Pyxis Medstation", the DOP stated "the language has to be added" upon inquiry if the education to prevent creation of future aliases and CS theft was incorporated into the policy.

The facility policy and procedure titled, "Pyxis Medstation" dated 5/5/14, indicated "Management: The use of the Pyxis Medstations is under the direction and control of the Department of the Pharmacy Services." In the section entitled "Security", the policy indicated, "1. User ID and Password: (a) Limit User ID access to Pyxis according to specific user class" and "Nursing Manager or Charge Nurse - issue registry nurse a temporary User ID and password." In the section entitled "References", the policy indicated "Institute for Safe Medication Practices http://www.ismp.org/Tools/guidelines/ADC_Guidelines_Final.pdf"

Review of the "Institute for Safe Medication Practices (ISMP) 2008 Guidance on the Interdisciplinary [involving more than one type of healthcare professional] Safe Use of Automated Dispensing Cabinets" indicated on page 8, "Ensure ADC System Security. Rationale: Security processes must be established to ensure adequate control of medications outside of the pharmacy and to reduce the potential for medication diversion from ADCs."