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Based on observations, staff interviews, and record review, the hospital failed to ensure frozen antibiotics (Zosyn and Azactam) were stored at the appropriate temperature range, in accordance with manufacturer's specifications to maintain medication potency and stability. Also, the medication refrigerator temperature logging was not consistently recorded daily for three of six observed medication refrigerators.

Findings:

1. During medication storage inspection at the pharmacy on 11/7/10 at 10:30 am, in the company of Pharmacist A, the pharmacy's medication freezer temperature log for 12/10 indicated the temperature range was set from -10 to -20 Celsius (°C). The freezer contained 120 doses of frozen premixed Zosyn Injection Solution in single dose plastic containers and 72 doses of frozen premixed Azactam Injection Solution in single dose plastic containers. Zosyn and Azactam are potent antibiotics used to treat potentially life-threatening infections.

Review of the manufacturer's storage instructions on the antibiotics' manufacturer labels indicated to store at -20 °C or 4 Fahrenheit (4°F) or below.

Pharmacist A said the freezer temperature range had been set from -10 to -20°C, so the temperature never went down below -20 °C. She said the antibiotics had been in the freezer for more than two months. At 11:40 am, Pharmacist A said the antibiotics were disposed of after checking with the manufacturer.

Review of the hospital's current policy regarding medication storage titled, "Medications: Procurement, Storage and Control," revised 10/07, reflected, "Medications requiring freezing shall be stored at the temperatures 4°F-14°F (-20°C to -10°C)." Storing above-mentioned frozen antibiotics at -20°C to -10°C is not consistent with the manufacturer's storage requirements.

The CDPH (California Department of Public Health) issued an All Facilities Letters (AFL 09-56) in 12/10/09 regarding Medication Safety: Storage of Medications Requiring Refrigeration. The principles of proper medication storage include the following:

"Development and implementation of policies and procedures to ensure safe storage of medications under proper conditions (e.g., temperature, humidity, protection from light and security)...Storage equipment (e.g., refrigerators, thermometers, carts and cabinets.) is maintained in accordance with standards of practice and/or manufacturer recommendations to ensure proper functioning. Adherence to pharmaceutical manufacturer requirements for product storage."

2. A visit to the Module 3 Medical Unit was conducted with Admin C on 12/6/10 at 2 pm. Admin C explained that manual monitoring was being used throughout the hospital as the electronic remote monitoring was not yet implemented. The review of the medication refrigerator temperature log for 12/10 reflected the temperature was not logged on 12/3/10 and 12/4/10. Admin C said the requirement was to have medication refrigerators temperature recorded daily to ensure the temperatures were within range. She explained that nursing staff were to record the temperature on the log daily, and other staff were to ensure that logging was done (a double checking system). She could not explain why the temperature logging was not done on the mentioned dates.

On 12/6/10, the Module 3 refrigerator contained different types of insulins (for diabetes), Marinol (for severe nausea/vomiting or as an appetite stimulant), and other refrigerated medications.

A visit to the Module 2 Medical Unit was conducted at 3:30 pm The 12/10 temperature log for Module 2 medication refrigerator revealed the nursing staff did not log the temperature on 12/3/10.

During a medication pass observation on 12/7/10 at 9:05 am in the presence of Admin C, the medication refrigerator temperature log at the Surgical Unit revealed the temperature was not recorded on 12/5/10.

Based on observation, interview, and record review, the facility failed to ensure the policy for the prevention of methicillin resistant staphylococcus aureus (MRSA - an antibiotic resistant bacterial infection) transmission were followed by dietary staff (DS) UU.

Findings:

On 12/6/10 at 9:05 am, Patient 121's room was noted to have a sign indicating she was on contact isolation precautions. This sign further instructed all persons entering the room to wear a gown and gloves. DS UU was observed in Patient 121's room without a gown or gloves.

On 12/6/10, the facility policy titled, "Methicillin Resistant Staphylococcus Aureus (MRSA) Active Surveillance/Screening Cultures," dated 12/08, indicated that the facility had a requirement for MRSA patients requiring staff to wear gowns and gloves upon entrance to the patient room.

In a concurrent interview, Administrative Staff TT acknowledged that the facility policy for MRSA precautions was not implemented.