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GEORGETOWN BEHAVIORAL HEALTH INSTITUTE 3101 S AUSTIN AVENUE GEORGETOWN, TX 78626 May 8, 2019
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
Based on a review of clinical records, facility documentation and interviews with staff, the facility failed to maintain an accurately written medical record for each patient.

Findings were:

During a review of the clinical record for patient #1, the following was noted:

* Forms titled "Admission Medication Reconciliation - Psychiatric" and "Admission Medication Reconciliation - Medical" had not been filled out with the names of patient #1's medications. A line had been drawn through both forms and the attending physician had signed them on 1-10-19 at 8:50 am. The intake assessment for patient #1 contained a section to be completed with the patient's current medications and numerous medications had been listed. Instructions at the top stated that, if there were current medications, a medication reconciliation for inpatient admission was to be completed.

Facility policy PHR-201 titled "Medication Inventory/Reconciliation" states, in part:
"2.0 Policy:
It is the policy of the facility to reconcile medications upon admission, transfer, and discharge from the facility. This is a mandate per the Joint Commission National Patient Safety Goals.
...
4.0 Procedure:
4.1 At the time of admission, the admitting nurse will reconcile the medication history provided by a MAR [medication administration record] from previous facility, discharge paperwork from a facility, patient recall, prescriptions, patient medication list, or patient/family record.
4.2 The information will be recorded in the Medication Reconciliation section of admitting paperwork and will include:
...
4.2.4 Medications will be checked Yes or No to continue at the hospital. This section constitutes as(sic) a doctor's order."

An order written for patient #1 on 1-10-19 at 8:50 am by the attending physician stated "Fentanyl patch 25 mcg [micrograms], q 3 days x [for] pain, use own med[ication], change new patch tomo[rrow]". Based on the date of the order and the facility's own standardized dosing times, the patch was to be replaced on 1-11-19 at 9:00 am. The patient was admitted with a Fentanyl 25 mcg patch, the receipt of which was appropriately inventoried and signed off on by 2 nursing staff.

Patient #1 completed a "request for release" at 8:01 pm on 1-10-19. The "patient home medications" form for patient #1 (on which had been documented the receipt of the Fentanyl patch at admission) contained a hand-written notation that said "used 1-11-19" and the initials [staff #2's initials]. The facility document titled "Home Medication Control Count Sheet" provided documentation that the oncoming, day-shift nurse (staff #1) on 1-11-19 started the shift with 1 Fentanyl patch and gave 1 Fentanyl patch during the same shift, ending with -0- in the column marked "end amount". In an interview with staff #5, staff #5 identified that the entry line was signed by [staff #1]. Staff #5 stated that there had been a nurse call in sick the for the morning shift on 1-11-19 and that staff #2, who had worked the night shift beginning 1-10-19, had stayed over a few hours until an agency nurse could arrive to work the rest of the shift. A review of the MAR (medication administration record) revealed that staff #2 had circled his own initials (indicating that the medication was not given) next to the Fentanyl patch ordered to be changed on 1-11-19 at 9:00 am. There was no nurse's note to indicate why the patch had not been changed as ordered. There was also no additional documentation to indicate that the oncoming nurse (staff #2) had changed the patch, where the new patch had been applied and how the old patch (a controlled substance) had been disposed of. Note: a "patch" had been documented on the left, posterior shoulder during the skin check at the time of patient #1's admission.

A review of facility policies revealed no pharmacy or nursing policy addressing the use of fentanyl patches to include proper application, disposal, documentation and storage. In an interview with staff #7, staff #7 stated that, because Fentanyl patches were not on the hospital formulary, there was no policy available to address their use.

According to the Drug Enforcement Administration at https://www.deadiversion.usdoj.gov/schedules/:
Schedule II/IIN Controlled Substances (2/2N)
Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.
Examples of Schedule II narcotics include: hydromorphone (Dilaudid), methadone (Dolophine), meperidine (Demerol), oxycodone (OxyContin, Percocet), and fentanyl (Sublimaze, Duragesic). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.

According to resource guide https://online.lexi.com/lco/medguides/ 5.pdf:
Important information about Fentanyl transdermal system:
o Proper disposal of Fentanyl transdermal system after use and for unused patches when no longer needed: Fold the sticky sides of the patch together and flush down the toilet. Do not put patches in a trash can.
When using Fentanyl transdermal system:
o Do not change your dose. Apply Fentanyl transdermal system exactly as prescribed by your healthcare provider.
o See the detailed Instructions for Use for information about how to apply and dispose of the Fentanyl transdermal system patch.
o Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
o You should wear the Fentanyl transdermal system patch continuously for 3 days, unless advised otherwise by your healthcare provider.

Facility policy PHR-184 titled "High Alert Medications" states, in part:
"4.0 Procedure:
...
4.2 Opiates: ...Scheduled medication patches are not on the formulary due to diversion abuse potential."

Facility policy PHR-128 titled "Controlled Medication" states, in part:
"1.0 Statement of Purpose:
The facility will establish standard procedures with controlled medication to ensure safe and appropriate use."

Facility policy PHR-159 titled "Medication Administration and Records" states, in part:
"1.0 Statement of Purpose:
To establish procedures for timely, accurate and safe administration of medication.
...
4.3.1.19 If a scheduled medication is refused or not given, then the medication time is circled; and the nurse's initials are written directly to the right of the refused time. In addition, the nurse will place the appropriate note in the chart."

In an interview with staff #1 on 5-8-19, staff #1 was asked if she remembered working a shift at GBHI in January 2019 and a situation where she applied a Fentanyl patch to a patient sounded familiar. She replied "No. It doesn't. I don't recall that." When prompted with patient #1's name and age, she stated "I don't remember him and I don't remember putting a patch on him."

The above was confirmed in an interview with the CEO and other administrative staff on the afternoon of 5-8-19.