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Based on observations, review of medical records (MR) and facility documents, and interviews with staff (EMP), it was determined that the nursing services was not provided in accordance with acceptable standards of practice as evidence by failing to ensure that controlled medications were monitored and administered to prevent drug diversion (A0405).

Cross Reference:
§482.23(c) Standard: Preparation and Administration of Drugs

Based on observations, review of medical records (MR) and facility documents, and interviews with staff (EMP), it was determined that controlled medications were not monitored and administered to prevent drug diversion for six out of 14 medical records (MR1, MR2, MR3, MR10, and MR12).

Findings include:

A review of facility policy, "Safe Use of Opioids in the Hospital," effective June 1, 2022, revealed " ... Monitoring should be individualized for each patient based on his or her response to medications."

A review of "Medication Guide" for Suboxone, a controlled sublingual medication used to treat opiate addition, revised June 2022, revealed " ... Suboxone may cause serious and life-threatening breathing problems. ... Do not stop taking Suboxone suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine (physical dependence). ... Never give anyone else your Suboxone sublingual film. They could die from taking it. Selling or giving away Suboxone sublingual film is against the law. ..."

Review of MR1 "Behavior Note," dated August 7, 2024, revealed that the patient reported to EMP16 that another patient was giving them their prescribed Suboxone. Patient indicated that they had been taking about "a quarter strip" of the medication for about two weeks. The provider was notified.

Review of MR1 "Medical Staff Progress Note," dated August 8, 2024, revealed that the treatment team met with the patient and that the patient refused a urine drug screen and indicated that they would come up as positive as they had been taking Suboxone not prescribed to them.

Review of MR2 "Medical Staff Progress Note," dated August 6, 2024, revealed " ... Last evening, [patient] was found with what appeared to be a sublingual film that was concealed in a small piece of paper. [Patient] identified this as Suboxone ...". Further review of the note revealed that the patient indicated that they received the medication, during recreation, from another patient located on another unit. It was indicated that the patient would be placed in "state clothing" so that their personal clothing could be laundered to ensure that there were no other films present. In addition, it was indicated that the patient would undergo random drug screening due to "significant history of diversion and/or contraband possession."

Review of MR3 "Physician Orders," dated May 31, 2024, revealed an order to check the patient's mouth after medication administration and to keep the patient in an open area for "15 minutes after medications."
Review of MR3 "Behavior Note," dated June 2, 2024, revealed that the patient was reminded to sit in the day area for twenty minutes while their Suboxone medication fully dissolved in their mouth. The note indicated that two staff observed the patient removing the Suboxone film from their mouth and tucking it into their sleeve. Nursing approached the patient and subsequently the patient provided the medication back to the nurse. The patient' s provider was notified of the incident and the provider gave the approval to administer the medication to the patient, but to monitor the patient "very closely, until completely dissolved." Further review of the note revealed "Unit RN sat with [patient] as instructed until medication was completely dissolved."

Review of MR10 revealed that on August 12, 2024, the patient reported not feeling well. A review of "Cumulative Vital Report," dated August 12, 2024, revealed that the patient's blood pressure was elevated, had an elevated temperature and pain level was rated as a "10." Review of MR10 "Behavior Note," dated August 13, 2024, revealed that the provider was notified of the patient's vitals and that the provider ordered a medication to treat the patient' s high blood pressure and ordered a urine drug screen. The provider was notified that the patient tested positive for Buprenorphine (medication used to treat opiate addiction, like Suboxone). Further review of the patient's medical record revealed that the patient did not have an order for this medication.

Further review of MR10 "Behavior Note," revealed that the patient indicated that they were getting "Suboxone" from another patient on another Unit. Patient was prescribed Naltrexone, a medication to help with individuals with opioid use disorder, who have stopped taking opiates, manage their cravings and remain drug-free.

Interview on August 16, 2024, at 3:03 PM, with MR10, revealed that they previously received Suboxone from another patient, but did not disclose as to which patient provided it to them. MR10 indicated that there were other areas in the facility in which patients could obtain Suboxone from other patients.

On August 19, 2024, at 10:29 AM, with EMP14, a review of video footage of medication administration was performed. Review of the footage, dated August 5, 2024, showed MR3 receiving their Suboxone. At 8:14:22 AM, the patient is observed walking away from the window, removing their Suboxone and placing at the top of their sweatpants. At 8:29:16 AM, the is not observed to receive a check of their mouth but the medication monitor provides a "thumbs up" and the patient walks away. EMP14 revealed that the patient's mouth is supposed to be check to ensure that the Suboxone film is in the gum area. EMP14 indicated that the patient is then to wait in the day area while being monitored for at least twenty minutes. The patient's mouth is then to be checked again to ensure that the film/strip is dissolved. EMP14 confirmed that the medication process was not followed.

On August 20, 2024, at 11:35 AM, with EMP1, a review of video footage of medication administration was performed. Review of the footage, dated August 19, 2024, revealed that at 8:20 AM, MR12 received their medication, identified as Suboxone. At 8:20:05 AM, MR12 is observed walking away from the medication administration window with what is identified as Suboxone films in their hand. At 8:20:11 AM, MR12 appears to look around and then walks out of sight of the video. EMP1 confirmed that the patient was not administered the medication in accordance with medication administration protocols.

The facility failed to administer controlled medications in accordance with accepted standards of practice, failing to visualize the medication being placed into the patient's mouth before leaving the medication administration area and failing to adequately monitor the patient to ensure that the patient did not leave the area until medication was fully dissolved in order prevent diversion to another patient. In addition, the facility failed to adequately investigate incidents of drug diversion to prevent reoccurrence.