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Based on medical record reviews, document reviews and staff interviews, it was determined the facility failed to have oversight of a physician pre-signing prescriptions. This failure has the potential to negatively impact all patients receiving care at the facility. (see tag A1079)

Cross Reference:
§482.54(b)

Based on observation, document review, and staff interview, sleep lab management failed to ensure that physicians were not signing blank documents for staff to copy and complete, including the prescription area, for the initiation of obtaining medications for the treatment for Narcolepsy at the Sleep Lab; affecting one (1) Patient (Patient #1) of five (5) reviewed, who were ordered Xywav and/or Xyrem. This failure has the potential to affect all patients being treated medically for Narcolepsy or Idiopathic Hypersomnia. (Refer to 482.54)

Findings include:

A review of the medical record for Patient #1 was completed, and revealed a "Xywav and Xyrem REMS Prescription Form," (form) dated 03/27/24, that appeared to be completed in it ' s entirety, including the prescription dose, by Employee # 6. The form was signed by Employee #13. Six (6) of these blank forms signed by Employee #13 located in a file cabinet in the control room in the sleep lab.

A telephone interview was conducted on 07/16/24 at 9:50 a.m. with Employee #13 regarding the forms. Employee #13 stated: "The form is filled out to initiate the process of obtaining the medication for the patient. The MA fills out the top of the form and I fill out the dosage information. The medications are given for Narcolepsy and Idiopathic Hypersomnia. They are a controlled substance, and it is a process that we have to go through to get the medication. The patient will come to the clinic after their sleep studies, and options are discussed. The medications have interactions with alcohol and other medications and may have psychotic side effects. The patient will fill out an enrollment form, and we fill out our forms. The forms are sent with medical records to the only pharmacy that handles the medication] and the insurance. It is a process, and sometimes we have to resubmit documentation. Once it is approved, we can send the prescription through Epic [computer e-pharmacy]. It all has to go through me. Any time I make a dosage change, we follow the same process."

An interview was conducted on 07/18/24 at 12:33 p.m. with Employee #13. Employee #14 examined the pre-signed form found in the control room and confirmed that it was their signature on the blank form. Employee #13 then examined the form filled out for Patient #1, dated 03/27/24. Employee #13 confirmed that the MA had filled out the entire form, including the prescription, and it appeared to be a copy of the blank pre-signed form. Employee #13 stated: "I recall this. I had been talking to [Patient #1] about starting the medication, and [he/she] was on the fence. I had submitted the paperwork last November, and [he/she] decided against it. [The November documentation was reviewed, and the prescription area was completed by the physician, and the physician signature was not the same as the blank copies]. In March, [he/she] was contemplating starting it again. I signed the paper to get the process started, waiting to hear back from the patient. I told the MA I would fill out the rest later. I frankly had forgotten about it. I had discussed it with the MA, who said they would fill in the paperwork if they heard back from the patient. The prescription is the standard starting dose. I ' m not sure where the MA got it from. I do not give verbal orders for medications to an MA. I am responsible for filling out the prescription area and should not have done that [left a blank signed form]. I had absolutely no idea that the blank form was copied - especially six (6) times. I only have four (4) patients on the medication at this time. I am very upset that I left a blank signed form, and that copies were made. I have no idea who would have copied it. The company has changed the process just this week where the entire process will be completed online, so this will never happen again."

A zoom interview was conducted on 07/18/24 at 10:45 a.m. with Employee #11 regarding pre-signed forms. Employee #11 stated: "I oversee the medical staff of the sleep lab. I found out about the pre-signed forms on Monday." Employee #11 then viewed the blank form with Employee #13 ' s signature, and confirmed that it was an old form that was no longer in use; and that the process just recently changed, and will be completed electronically without the use of the documents. Employee #11 concurred the forms should not be pre-signed. Employee #11 stated: "I complete the medication dosage area, and would never give a verbal order for medication to an MA. The MA fills out the top portions, pulls the appropriate medical records from Epic, and sends them to [specific pharmacy]. I call and coordinate everything with the pharmacy."

A zoom interview was conducted on 07/18/24 at 11:05 a.m. with Employee #12, who stated: "I do not have direct oversight of the sleep clinics. Employee #1 reports to me in the leadership meetings." Regarding the pre-signed forms, Employee #12 stated: "There should be no pre-signed forms of any kind anywhere. That is totally unacceptable."

An interview was conducted on 07/16/24 at 10:35 a.m. with Employee #1 regarding the pre-signed blank copied forms that were found in the control room. Employee #1 confirmed that the form for Patient #1, dated 03/27/24, looked like it was completed entirely by Employee #6, except for the signature, which matched the copies in found in the drawer, and signed by Employee #13.