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PALOMAR HEALTH DOWNTOWN CAMPUS 555 EAST VALLEY PARKWAY ESCONDIDO, CA 92025 May 4, 2018
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on interview, and document review, the hospital failed to ensure policies and procedures were effectively implemented to prevent controlled substance diversion (unauthorized use).

Findings

Controlled Substances/Medications are medications with high potential for abuse or misuse. The Drug Enforcement Agency (DEA) classified them into schedules, from schedule II to schedule V. Schedule II has the highest potential for abuse or misuse, schedule V has the lowest potential for abuse or misuse.

Suspicious activities occurred on four separate occasions, from 4/4/17 to 5/10/17. Registered Nurse (RN) 1 removed 6 milligram (mg) of hydromorphone (a schedule II medication) injection, however, the hospital could not account for all the doses removed.

In addition, the hospital did not report the theft or loss to law enforcement as required by hospital policy.

These failures resulted in theft or loss of controlled medications. In addition, RN 1 potentially could have provided care while under the influence of controlled medications. Therefore, the hospital could not ensure care was safely provided to its patients.

Findings:

A joint interview and record review was conducted on 4/20/18 at 9:45 A.M. with the Interim-Chief Nursing Officer (CNO), Director of Regulatory Affairs (DRA), Director of Pharmacy (DOP), and Director of Emergency Department (DIR 1).

They determined RN 1 diverted 4.5 mg of hydromorphone: 0.5 mg on 4/4/17, 2 mg on 4/11/17, 1 mg on 4/12/17, and 1 mg on 5/10/17.

1. On 4/4/17, RN 1 removed 2 mg (two units of 1 mg) of hydromorphone for Patient 1. RN 1 was not assigned to this patient. RN 1 documented 1.5 mg was administered, and "wasted" 0.5 mg with a witness (RN 3).

They stated RN 1 indicated there was a "verbal" order (medication order given by the prescriber to the nurse verbally) for 1 mg hydromorphone, given by MD 1. They stated MD 1 was unable to recall the event.

RN 1 documented 1.5 mg was administered (the order was for 1 mg).

They stated they expected RN 3, as a witness, to see the medication dispensing and waste, as well as verifying the medication order and dose together with RN 1.

They stated the "verbal" order was "placed" into the system 11 minutes after the medication was dispensed from the system. Therefore, RN 3 would not have been able to verify the medication order and dose with RN 1 at the time the medication was dispensed.

2. On 4/11/17, RN 1 removed 1 mg of hydromorphone at 8:16 P.M. and 9:27 P.M. (2 mg total), without a prescriber's order.

They stated RN 1 did not indicate these were medication errors.

3. On 4/12/17, RN 1 removed 1 mg of hydromorphone for Patient 2, then "wasted."

They stated there was not a prescriber's order to remove this dose.

During a telephone interview on 4/30/18 at 2:05 P.M., the CNO, DRA, and DIR 1 stated 1 mg was "wasted" with a witness (RN 4).

4. On 5/10/17, RN 1 removed 1 mg of hydromorphone under RN 2's login. The medication was not accounted for.

They stated the Automated Dispensing Machine (ADM, where the medications were stored for dispensing) had a one minute time-out (the machine would automatically log the user off if the user did not manually log off). They stated the users were expected to log off after each use.

According to the hospital's policy, [ADM] MedStations, dated 2/22/17, "...Upon completion of the transaction, the Nurse will log-off the system."

5. During a telephone interview on 4/30/18 at 2:05 P.M., the CNO, DRA, and DIR 1 stated they did not report RN 1 to law enforcement, because "reporting to the police was not part of the process."

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 2/17/17, "...If an employee... is believed to be diverting medications... Reporting to outside agencies will be coordinated... Local Police Department when appropriate...."
VIOLATION: REPORTING ABUSES/LOSSES OF DRUGS Tag No: A0509
Based on interview, and document review, the hospital failed to report the loss of controlled substances to the chief executive officer (CEO) for approximately six months.

Controlled Substances/Medications are medications with high potential for abuse or misuse. The Drug Enforcement Agency (DEA) classified them into schedules, from schedule II to schedule V. Schedule II has the highest potential for abuse or misuse, schedule V has the lowest potential for abuse or misuse.

As a result, the CEO potentially could not determine if additional measures should have been taken immediately to prevent further incidents, or a broader investigation should have been initiated.

Findings:

A joint interview and record review was conducted on 4/20/18 at 9:45 A.M. with the Interim-Chief Nursing Officer (CNO), Director of Regulatory Affairs (DRA), Director of Pharmacy (DOP), and Director of Emergency Department (DIR 1).

They stated RN 1's hire date was 2/1/16 and separation date was 5/25/17.

They determined RN 1 diverted 4.5 mg of hydromorphone (a schedule II medication): 0.5 mg on 4/4/17, 2 mg on 4/11/17, 1 mg on 4/12/17, and 1 mg on 5/10/17.

They stated they did not investigate all of RN 1's activities related to controlled substances during her employment there [to determine the full scope of diversion] because they had enough information to move forward with her employment termination.

An interview and review of RN 1's employment record was conducted on 4/20/18 at 12:10 P.M. with Talent Acquisition (HR 1), Human Resource Director (HR 2), and Director of Talent Acquisition (HR 3).

They indicated RN 1 provided three references: (1) a manger at her previous employment agency; (2) a manager at a hospital in Los Angeles County; and (3) a co-worker at a hospital in Riverside County.

Page 1 of the reference Feedback Report indicated "Duplicate IP Address."

IP address is a unique address of the computer's location.

Pages 5 and 6 of the Feedback Report indicated References 1 and 2 had "Duplicate IP Address." Reference 1 completed the reference report on 1/18/16 at 6:16 P.M. Reference 2 completed the reference report on 1/18/18 at 6:34 P.M. The IP addresses where Reference 1 and Reference 2 completed the report were identical, and the reference reports were completed approximately 15 minutes apart. The IP addresses were in bold red color text.

In addition, page 6 of the Feedback Report indicated, "...A bold red color text for an IP address on the report indicates the same IP Address was used more than once and that could be a problem with the authenticity of the References that a Candidate has provided... one or more of the References have a matching IP address... this means that the same computer (or computer system) was used by these References...."

They stated it was "...not logical..." to have duplicate IP address, and there should have been some review and explanation for this. They acknowledged there was no explanation for the duplicate IP address. In addition, they stated the hospital did not have procedures to address duplicate IP address on the reference report.

During a telephone interview on 4/30/18 at 2:05 P.M., the CNO, DRA, and DIR 1 stated the CEO was informed about the loss of controlled substances on 11/15/17, approximately six months after they determined RN 1 diverted controlled drugs. They acknowledged the information should have been reported to the CEO sooner. They also stated the staff involved in the decision-making process related to this incident was no longer with the hospital, and they could not explain why the incident was not reported to the CEO for approximately six months.

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 2/17/17, "...Abuses and losses of controlled substances must be reported to... the chief executive officer, as appropriate."