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Based on observation, staff interview, and medical record review, the hospital failed to ensure medications were prepared and administered as ordered by the physician, in accordance with the hospital's policy and procedures, or per manufacturer's guidelines, when:

1. Medication orders for propofol (an anesthetic used to produce sedation) were not carried out as per physician order for two of three patients (29 and 30). For Patient 29, the starting dose was not carried out correctly. For Patient 30, the propofol was not titrated as ordered, and the sedation assessment and monitoring was inconsistent with the physician order. The failure had the potential to result in adverse effects for patients.

2. The hospital failed to provide ongoing sedation assessments for three of three patients (27, 28, and 32) receiving medications via the PCA (patient controlled analgesia, an interactive method by which the patient self-administers small amount of narcotics intravenously [IV] at frequent intervals upon demand by pushing a button). Sedation assessments were not routinely documented following initiation, dose increase, and at the minimum interval stipulated by policy. Sedation assessment is essential in monitoring the clinical effects of narcotic PCA.

3. The hospital failed to provide appropriate training to a licensed staff regarding disinfecting a medication vial stopper when using a Mini-Bag Plus container system (a standard diluent container that allows for drug mixture). This failure had a potential to expose patients to infections.

Findings:

1. On 5/30/13 at 10:05 a.m., a review of the electronic medical records for Patients 29 and 30 was conducted at the Surgical Intensive Care Unit (SICU) with the ICU Manager in the presence of the director of pharmacy (DOP) and administrative staff (Admin) A. Patient 29 was admitted to the hospital for small bowel obstruction, for which he underwent surgery. On 5/23/13, he had a physician order for propofol via intravenous infusion, to start at 5 mcg/kg/min (micrograms/kilogram/minute), with titration (increase or decrease) parameters of 10 mcg/kg/min every 10 minutes to maintain Ramsey scale (sedation scale) of 2 to 3. The record showed the propofol was started at 15 mcg/kg/min, instead of 5 mcg/kg/min as ordered. There were no other physician orders or nursing narratives explaining the reason for deviation from the physician order. The ICU Manager agreed the staff did not administer the propofol as ordered.

Patient 30 was admitted to the hospital for toxic colitis (inflammation of the colon) and was transferred to the SICU after surgery. On 5/15/13, she had a physician order for propofol intravenous infusion to start at 5 mcg/kg/min, to titrate by 10 mcg/kg/min every 10 minutes, to maintain goal RASS (Richmond Agitation Sedation Scale) score for -1 to 1. The record showed the propofol was started at 5 mcg/kg/min at 1:15 a.m. At 1:29 a.m. (14 minutes later), the rate was increased to 40 mcg/kg/min, an increase of 35 mcg/kg/min, instead of 10 mcg/kg/min every 10 minutes as ordered. Also, it was noted the nursing staff used the Ramsey scale, instead of RASS, to monitor the patient's sedation during the propofol treatment. Ramsey sedation score and RASS are not equivalent; as each uses different scoring designation. The ICU Manager confirmed the staff did not follow the physician order and should have the order clarified when the sedation scale was different from what they were accustomed to.

To date, the manufacturer of propofol indicates the following under Dosage and Administration: "Intensive Care Unit (ICU) sedation should be initiated slowly with a continuous infusion in order to titrate to desired clinical effect and minimize hypotension. When indicated, initiation of sedation should begin at 5 ?g/kg/min (0.3 mg/kg/h). The infusion rate should be increased by increments of 5 to 10 ?g/kg/min (0.3 to 0.6 mg/kg/h) until the desired level of sedation is achieved." (http://dailymed.nlm.nih.gov; accessed 6/7/13)

2. The hospital policy and procedures on "(PCA) PATIENT CONTROLLED ANALGESIA," dated 1/13, required the following documentation: "Respiratory Rate and Sedation level: enter the patient's respiratory rate and sedation level 1 hour following the initiation of PCA therapy, after every increase in dose then every 4 hours. More frequent monitoring may be needed for patients considered at risk of over sedation/respiratory depression."

On 5/29/13 at 4 p.m., a review of Patient 27's medical record with Admin A and the DOP revealed the patient had an order for Dilaudid (a potent narcotic) PCA on 5/26/13 at 12:39 p.m., which was initiated at 1:43 p.m. (same day). The PCA was continued until 8:57 p.m. on 5/28/13. There was no evidence of sedation assessment 1 hour following the PCA initiation and every 4 hours after. Admin A and the DOP confirmed there was no sedation level documentation for Patient 27 during the PCA therapy.

On 5/30/13 at 9:35 a.m., a review of Patient 28's medical record was conducted at the Mother Infant Care Center (MICC) with a MICC nurse (RN B), Admin A, and the DOP, revealed the patient had a physician order for Dilaudid PCA on 5/29/13 at 3:15 p.m. It was initiated at 3:36 p.m. and continued until 9:46 a.m. the next day. There was no documented evidence the sedation assessment 1 hour after initiation and every 4 hours after as stipulated per policy. Admin A and RN B verified this finding.

On 5/30/13 at 1:30 p.m., a review of Patient 32's medical record with a registered nurse (RN C), Admin A, and the DOP revealed the patient had a physician order for morphine PCA on 5/16/13 at 3:18 p.m., which was started at 4:36 p.m. (same day). From 5/17/13 to 5/19/13, the patient had three morphine PCA order changes, with a dose increase at 7:30 a.m. on 5/17/13. There was no documented evidence of sedation assessment 1 hour following the initiation, after the dose increase, and at every 4 hour intervals as stipulated by policy.

In a recent Medication Safety Alert, dated 5/30/13, the Institute for Safe Medication Practices (ISMP) documented the following in regards to sedation assessment in PCA use: "Sedation is an extremely useful assessment parameter to observe the clinical effects of opioids. In fact, sedation is the most important predictor of respiratory depression in patients receiving IV opioids... Sedation generally precedes significant respiratory depression... for patients receiving PCA, early recognition of excessive sedation and intervention is essential."



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3. During medication pass observation on 5/29/13 at 11:25 a.m., in Rehab 2, RN A was observed preparing an IV antibiotic for infusion. RN A removed Zosyn (IV antibiotic) 4.5 grams vial cover and attached the Mini-Bag plus to the vial without disinfecting the stopper.

During an interview with the Rehab Manager on 5/29/13 at 3:45 p.m., she said nurses were supposed to disinfect the Zosyn stopper with an alcohol swab before attaching Mini-Bag plus container system.

Review of the manufacturer's manual titled "Mini-Bag Plus Container System" dated 04/09, under directions, indicated to remove the vial cover and disinfect the stopper.

Review of the hospital training manual for Mini-Bag Plus container system titled "Key Antibiotics and Infusions to be placed in the pyxis machines" dated June 2012, indicated to remove the vial cover and disinfect the stopper prior to attaching the Mini-Bag Plus.

During an interview on 5/30/13 at 3:05 p.m., Admin A reported the Rehab Manager reviewed the training records and was unable to find documentation of Mini-Bag Plus container system training for RN A.

Based on observation, interview, and record review, the hospital:

1. Failed to store medications within the temperature range specified on the manufacturer's packaging to maintain drug integrity, stability, and effectiveness, for two of two medication freezers. The failure had the potential to expose patients to the ineffective treatment of serious infections due to the use of expired and/or less than labeled strength medications.

2. Failed to ensure irrigation fluids in the operating room (OR) warmer were stored separate from the blankets as per hospital guidelines; fluids and blankets required different temperature ranges for storage.

Findings:

1. During a tour of the hospital main pharmacy on 5/28/13 at 11 a.m. with the director of pharmacy (DOP) and a pharmacy supervisor, two medication freezers were identified; one inside the pharmacy (Freezer 1) and the other outside the pharmacy (Freezer 2). Both contained Baxter's frozen antibiotics such as vancomycin, Penicillin G Potassium (to treat serious infections). A review of the temperature tracking on a computer monitor showed the average temperature reading within the last month for Freezer 1 was -3.6?F (negative 3.6 degrees Fahrenheit); the current temperature reading for Freezer 2 was -3.3?F. The DOP said the hospital set the freezer temperature range from -50 to 5?F.

The storage instructions on the Baxter's frozen antibiotics observed during the visit indicated to store them at -4?F or below. Thus, any temperature above - 4?F (such as -3?F) would not meet the temperature specified by manufacturer. The DOP and the pharmacy supervisor confirmed the current freezer temperature setting did not meet the manufacturer's specification for storage of the said frozen antibiotics.

On 5/29/13 at 8:20 a.m., the DOP provided a newly revised policy and procedure on "Medication Storage and Refrigeration." He said the old policy reflected to store frozen medications at 5?F or colder.

2. A visit to the OR was conducted on 5/29/13 at 11 a.m. with the OR manager, the DOP, and administrative staff (Admin) A. Inspection of the OR warmer revealed blankets were stored in the same compartment as the irrigation fluids (such as 0.9% sodium chloride and lactated Ringer's solutions). The storage instruction posted on the outside of the warmer read: "Fluids and blankets should be stored separately for different temperature ranges." It indicated the maximum temperature range for irrigation fluids was 104?F and 109?F for blankets. When commenting about the combined storage, the OR Manager said, "They are not supposed to be stored together."

Based on observation, interview and hospital manual review, the hospital failed to ensure that 1 of 2 Code Blue tote bags (contains medications and equipments needed during life threatening medical emergencies) did not have outdated drugs available for patient use. This failure had the potential of allowing patients to receive deteriorated medication in an emergency situation.

Findings:

During an observation on 5/29/13 at 4:50 p.m. at the CCU (Coronary Care Unit), it was noted that the pericardiocentesis (a procedure where fluid is aspirated from the sac enveloping the heart) tray containing Lidocaine 1% injection (Anesthetic/numbing medication) expired in March 2013.

Concurrent interview with the DOP indicated the pharmacist checked the medication bag inside the Code Blue tote bag monthly but not the supplies from central warehouse. Pharmacist A claimed pharmacy thought the pericardiocentesis tray (from central warehouse) no longer contained Lidocaine injection.

The hospital Manual Standards of Care titled "CRASH CART, ADULT," under Process, indicated "the staff assigned to check the cart is responsible for noting the medication module expiration date and returning the expired medication module to the In-patient Pharmacy."