HospitalInspections.org

Based on observation, interview, document and record review, the facility failed to ensure policies and procedures were developed and implemented for distribution and control of drugs to ensure patient safety when:

1. Fentanyl (opioid or narcotic for pain) patch order that was contraindicated for one of five sampled patients (Patient 3) was not evaluated appropriately by pharmacy staff. This failure had the potential of exposing the patient to respiratory depression and death.

2. The list of drugs for the malignant hyperthermia (MH, an inherited muscle disorder triggered by certain drugs including succinylcholine and volatile anesthetics that may cause a fast-acting life-threatening crisis) cart did not indicate the location of chilled saline or insulin (to reduce potassium levels in the body).

3. Three emergency crash carts (containing medications and supplies for life threatening emergencies) were observed without a list of contents posted on the outside.

These failures (2 and 3) had the potential of preventing caregivers from quickly finding and using drugs required for resuscitating patients during a medical emergency.

Findings:

1) Review of Patient 3's clinical record with nurse manager (RN Mgr) C indicated that she was admitted to the facility on 2/26/16, with a diagnosis of severe degenerative arthritis (breakdown of cartilage in the joints leading to painful inflammation). Patient 3's list of home medications indicated that she was taking Tylenol (for pain) and ibuprofen (for pain and inflammation).

Review of Patient 3's physician orders dated 2/26/16, indicated an order for hydromorphone (opioid for pain) 0.5 milligrams (mg) every 6 hours as needed and a Fentanyl 12 mcg (micrograms)/hour transdermal (via the skin) patch every 72 hours. Review of Patient 3's medication administration record indicated that Fentanyl 12 mcg patch was administered on 2/26/16 to the right upper arm.

Fentanyl patch is a high potency opioid used for pain and has a boxed warning which is the strongest warning the FDA (food and drug administration) can require a pharmaceutical company to place on the labeling of a prescription drug, or in literature describing it. Following is part of the boxed warning: "Respiratory depression and death may occur with use of Fentanyl transdermal system, even when Fentanyl transdermal system has been used as recommended and not misused or abused ... Fentanyl transdermal system is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including ..., use in non-opioid tolerant patients."

The manufacturer package insert defines opioid tolerance as "Tolerance to an opioid of comparable potency must be established before prescribing Fentanyl transdermal system ... Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine (an opioid) daily, or at least 30 mg of oral Oxycodone (an opioid) daily, or at least 8 mg of oral hydromorphone daily or an desquamates (narcotic equivalence) dose of another opioid for a week or longer."

During an interview on 3/29/16 at 11:45 am, the Director of Pharmacy (DOP) acknowledged that Patient 3 was opioid naïve. DOP stated that there was no intervention noted in Patient 3's record that the pharmacist evaluating the order established opioid tolerance or followed up with the physician with concerns of Patient 3 being opioid naïve.

In an interview on 3/30/16 at 9:10 am, the DOP stated that there was nothing in the CPOE (computerized physician order entry) that prompted the physicians to evaluate opioid tolerance in a patient before ordering a Fentanyl patch. DOP also stated that there was nothing in the pharmacy program that required opioid tolerance evaluation. DOP stated that other boxed warning drugs had also not been entered into CPOE but they will be working on them.

Review of the facility policy, "Provider Medication Orders" indicated "The pharmacist will contact the provider when clarification of a medication order is needed."

Review of the facility policy, "Black Box Warning," dated 2/2016, indicated "The Pharmacy Director shall receive and review notification of package insert change for any medication, medication-related device or biological. Upon receipt of a change or update to a medication, medication-related device or biological the Pharmacy Director shall ...ensure that any information related to the medication is updated into the hospital's clinical information system. "

2. On 3/28/16 at 1:20 pm tour of the PACU (post anesthesia care unit) showed an emergency cart that was identified by RN Mgr C as the MH cart. The list of drugs on the MH cart did not include the location of chilled saline and insulin.

In a concurrent interview, RN Mgr C indicated the hospital followed MHAUS (Malignant Hyperthermia Association of the United States).

Review of MHAUS crisis management indicated "Cool the patient (using chilled saline) if core temperature is >39°C or less if rapidly rising. Stop cooling when the temperature has decreased to < 38°C."

3. On 3/28/16 at 12:10 am, an adult and a pediatric emergency crash cart was observed in the emergency room (ER) There was no list of contents posted on the outside. In a concurrent interview, ER manager, RN Mgr F confirmed there was no contents list on the adult and pediatric crash carts.

On 3/28/16 at 11:30 am, an adult emergency crash cart was observed in the Intensive Care Unit (ICU) without a contents list on the outside cover. In a concurrent interview, RN Mgr F acknowledged that there was no contents list for the cart on the outside cover.

Review of the facility policy, "Emergency Medicine: Crash Carts," dated 2/2016 indicated, "The contents shall be listed in a log on top of the cart ... "