HospitalInspections.org

Based on document review and staff interview conducted on 1/21/15, it was determined that the facility failed to ensure that pharmacy services are under competent supervision of a registered pharmacist.

Findings include:

1. The facility failed to provide adequate oversight to ensure that policies and procedures addressing Controlled Dangerous Substances (CDS) were followed. Refer to Tag A 491.

2. The facility failed to ensure control and accountability of CDS. Refer to Tag A 494.

3. The facility failed to ensure the development and implementation of policies and procedures to ensure appropriate access to the Narcotic Vault CII Safe by pharmacy personnel. Refer to Tag A 494.

4. The facility failed to ensure the development and implementation of policies and procedures addressing the storage and accountability of patient's own CDS prescription medication brought from home. Refer to Tag A 494.

Based on document review and staff interview conducted on 1/21/15, it was determined that the facility failed to provide adequate oversight to ensure the control and accountability of controlled dangerous substances.

Findings include:

1. During interview, Staff #1 and #5 stated that, on 12/11/14, three (3) milliliters of oral morphine sulfate liquid were unaccounted for in the pharmacy. Staff #5 stated that the Director of Pharmacy generated a Narcotic Vault Access Report for each pharmacist in an effort to determine who had received the missing morphine sulfate. As a result, the Director of Pharmacy identified many incomplete reasons for entry into the CII Safe by Staff #7.

a. The first incidence of incomplete entries occurred in October 2013. The incidence remained about 3 to 6 times a month until October 2014. At that time there was a sharp increase. There were 32 incidences in October and 47 incidences in November, and 19 instances in December, 2014 (through 12/11/14).

a. Staff #5 stated that the Director of Pharmacy did not counsel Staff #7 until December 29, 2014. He/she stated that Staff #7's employee file lacks evidence that counseling occurred on 12/29/14. The incidences continued throughout the month of December.

b. Staff #1 confirmed that, on 1/7/15, Staff #7 was terminated for suspicion of tampering and theft of controlled dangerous substances. Staff #1 confirmed that, based on the findings of the Narcotic Vault Access Reports, the tampering and theft had been occurring "for some time" and had not been one isolated instance.

2. Staff #1 confirmed that an incident report had not been completed by the Director of Pharmacy at the time of the loss, as required in the facility policy.

A. Based on document review and staff interview conducted on 1/21/15, it was determined that the facility failed to ensure control and accountability of Controlled Dangerous Substances (CDS).

Findings include:

1. During interview, Staff #8 stated that, on January 7, 2015, he/she removed a vial of Morphine 100mg/ml (milligrams/milliliter) from the Narcotic Vault CII Safe and discovered that the vial was empty. Closer examination of the vial revealed that the bottom seal on the box had been tampered with and that there was a very small hole in the middle of the vial cap.

2. Staff #8 stated that, on 1//15, all the vials in the Narcotic Vault CII Safe were checked for signs of tampering. He/she stated that there were signs of tampering with vials of Morphine 100mg/10ml, 10 ml and 50 ml vials of Fentanyl (50mcg/ml), and Dilaudid 1 ml vials. These medications are all Schedule II CDS. He/she stated that all the current supply of the affected medications were removed from stock and turned over to the local authority, a total of 314 vials of medications.

a. Staff #8 and Staff #5 stated that pharmacy staff had not reported that Scheduled II drugs had been tampered with prior to 1/7/15.

3. During interview, Staff #1 and #5 stated that, on 12/11/14, three (3) ml of oral Morphine Sulfate from the Narcotic Vault CII Safe were unaccounted.

B. Based on document review and staff interview conducted on 1/21/15, it was determined that the facility failed to ensure the development and implementation of policies and procedures to ensure appropriate access to the Narcotic Vault CII safe by pharmacy personnel.

Findings include:

Reference #1: The Pyxis CII Safe System User Guide states on Page 22, "Use the Narc Vault Access and Inventory function to verify Narc Vault inventory, put away standard compounds in the Narc Vault, and to access a door without a transaction." The guide states on Page 24, "To access the Narc Vault for other reasons [other than to verify inventory or put away compounds]...2. In the Narc Vault Access/Inventory screen, select Other (Reason). 3. Enter the reason for accessing the Narc Vault (maximum of 50 characters)..."

1. Review of Narcotic Vault Access Reports for Staff #7, from October, 2013 through December 2014, revealed incomplete documentation. He/she failed to enter a reason for accessing the vault. Instead, a letter of the alphabet or a period was entered.

a. An incomplete entry was made about 3-6 times per month from October 2013 until March 2014. Beginning in April 2014, the incidences increased. An incomplete entry was made 32 times in October, 47 times in November, and 69 times in December, 2014.

b. Staff #1 and #5 confirmed that the incomplete entries for access into the Narcotic Vault CII Safe were not discovered by the Director of Pharmacy until 12/11/14.

2. Facility Policy 3.26, titled "Controlled Drugs" only addresses monitoring of controlled drugs for diversion from units throughout the hospital. The policy does not address monitoring for proper access by pharmacy personnel accessing the Narcotic Vault CII safe.

C. Based on observation and staff interview conducted on 1/21/15, it was determined that the facility failed to ensure the development and implementation of policies and procedures addressing the storage and accountability of the patient's own controlled drugs brought to the facility.

1. Many plastic bags containing prescription vials of patient's own medication were found stored in the Narcotic Room in the pharmacy.

a. Upon interview, Staff #8 stated that, if patient's own medication included a controlled dangerous substance, it was stored in the Narcotic Room until returned to the patient upon discharge.

b. Staff #8 stated that the facility does not have policies and procedures addressing the accountability of patient's own controlled drugs.

i. Review of the contents of some of the plastic bags revealed that inventory of the quantity of each controlled drug was not recorded, the bags were not tamper proof, and a record of the amount of controlled drug returned to the patient was not recorded.

b. Staff #8 and #9 confirmed that there was no accountability for controlled drugs that were patient's own medications.