HospitalInspections.org

15036

A. Based on interview and record review, the provider failed to ensure the punch code to access controlled and noncontrolled medications in one of one catheterization (cath) laboratory (lab) had been changed after the termination of one of one independent contracted healthcare worker (registered nurse [RN] B) was suspected of drug diversion. Findings include:

1. Review of the provider's investigation of Fentanyl drug diversion revealed:
*On 8/1/19 independent contracted healthcare worker RN B had been terminated under suspicion of diverting Fentanyl.
*The hospital pharmacy purchased Fentanyl with a concentration of 100 micrograms (mcg) per 2 milliliter (ml) vials.
*From the cath lab and operating room (OR) 5 controlled medication lock box one Fentanyl vial found with the top removed from both areas were sent to an independent lab for potency testing.
*Vial number 2019-17506-01 potency was 6.34 percent (%) and vial number 2019-17507-01 potency was 11.1%. Both vials were below the manufacturer's potency level of 100 mcg/2 ml. The report had not identified which vial was from the cath lab or the operating room.

Interview on 8/14/19 with the following staff revealed:
*At 3:40 p.m. with RN C revealed the punch code had not been changed since RN B had been terminated.
*At 4:30 p.m. with cath lab and vascular lab director F stated the punch code could be changed but had not been changed since RN B had been terminated.

Interview on 8/15/19 with the following staff revealed:
*At 12:52 p.m. RN J stated the punch code had not been changed after RN B had been terminated.
*At 1:45 p.m. with pharmacist H revealed the punch code should have been changed as "staff is different." She had not been involved in changing the punch code when staff were no longer employed with the facility.
*At 3:30 p.m. with the director of nursing revealed the code not being changed was a problem and agreed there was a concern with narcotic security.

B. Based on record review, interview, and policy review, the provider failed to ensure controlled substance log sheets were accurate to reflect medication on hand and medication wastage for two of two patient care areas (cath lab and OR 5). Findings include:

1. Review of the provider's 5/30/19 to 8/8/19 controlled substance log for physician I revealed:
*The log was used to monitor Fentanyl 100 mcg/2 ml and midazolam/Versed 2 milligram (mg)/2 ml in the vascular lab.
*No documented narcotics were given or wasted from 5/30/19 through 6/10/19.
*On 5/30/19, a balance of 20 vials of Versed was documented on the controlled substance log sheet S311 as balance brought forward.
*On 6/11/19, the following doses were documented as given or wasted on controlled substance log sheet S311:
-Patient 13 was given 5 mg/2 ml of Versed and 1 mg/2 ml of Versed was wasted. Vials of Versed documented as 17 vials after patient dose.
-Patient 14 was given 4 mg/2 ml of Versed. Vials of Versed was documented as 15 vials after patient dose.
-Patient 12 was given 7 mg/2 ml of Versed and 1 mg/2 ml of Versed was wasted. Vials of Versed was documented as 12 vials after patient dose.
-The amount of vials documented after patient 12 should have been 11 vials instead of 12 vials.
*Controlled substance log sheet S312 had a 6/11/19 balance forward of vials of Versed documented as 12 vials.
*No correction of the vial count for Versed was made on the from 6/11/19 through 7/30/19.

2.a. Review of the medical record for patient 5 revealed:
*He had a cath lab procedure completed on 7/2/19.
*The case synopsis and sedation flowsheets dated 7/2/19 revealed RN B had administered a total of:
-Versed 1 milligram (mg).
-Fentanyl 25 micrograms (mcg).

Comparison of the pharmacy controlled substance log against the medical record case synopsis and sedation flowsheets documentation revealed RN B had:
-Removed two vials of Fentanyl (a total of 200 mcg) from the controlled medication storage box.
-Administered Versed 1 mg.
-Administered Fentanyl 25 mcg.
-Wasted Fentanyl 100 mcg.

Interview and review of the pharmacy controlled substance log on 8/15/19 at 1:45 p.m. with pharmacist H revealed:
*The Fentanyl documented waste should have been 175 mcg, not 100 mcg.
*Fentanyl was supplied as 100 mcg per 2 milliliters.
*RN B had removed two vials of Fentanyl (total of 200 mcg) from controlled storage.

b. Review of the medical record for patient 13 revealed:
*He had a left heart catheterization procedure on 7/12/19.
*Review of of the case synopsis and sedation report for that day revealed he had received Fentanyl 100 micrograms (mcg).

Review and comparison of patient 13's cath lab controlled substance log documentation against the flowsheets listed above revealed:
*He had been the first case that day.
*The cath lab controlled substance log starting count had been 10 vials of Fentanyl (100 mcg/2 ml).
*Two vials of Fentanyl had been removed leaving a total of 8 vials.
*RN A had documented on the controlled substance log she had administered 200 mcg and wasted Fentanyl 100 mcg.
*If RN A had administered Fentanyl 200 mcg and wasted Fentanyl 100 mcg; the total Fentanyl count should have been 7 vials remaining not 8. That would have meant 3 vials of Fentanyl had been removed not 2 vials.

Interview and medical record review on 8/15/19 at 4:10 p.m. with RN A regarding patient 13 revealed:
*She had administered Fentanyl 100 mcg during the patient's procedure.
*She had incorrectly documented Fentanyl 200 mcg had been administered on the cath lab controlled substance log.
*She had only removed 2 vials of Fentanyl from the controlled medication lock box not 3 vials.

3.a. Review of the controlled substance logs from 5/30/19 through 8/14/19 provided by pharmacist H for the cath lab revealed corrections in medication administration documentation had been made on that form as listed below:
*Seven errors had lines drawn through the information with an initial.
*Six errors when the staff wrote over existing information to make the corrections.
*Thirteen errors where the information had been scribbled out.

b. Review of the controlled substance logs from 5/30/19 through 8/14/19 provided by pharmacist H for the cath lab revealed forth-seven days where cath lab procedures had been performed. Seventeen of those days the staff had not completed an end of shift final day count signed off by two nurses for controlled and noncontrolled medications.

4. Review of the controlled substance logs provided by pharmacist H for the vascular lab revealed:
*No initial or end of the day counts were made on 6/11/19, 6/13/19, 7/23/19, 8/6/19, and 8/8/19.
*The end of day count for 6/25/19 was performed on 6/26/19.
*One date of balance forwarded was documented as a Sunday when no patient exams had been performed.
*Two errors of numbers with a line or lines drawn through and nurse's initials.
*Four errors of numbers with a line or lines drawn through and no nurse's initials.
*Three errors of numbers scribbled out with nurse's initials.
*Four errors of numbers scribbled out with no nurse's initials.
*Four errors of numbers written over with nurse's initials.
*Two errors of numbers written over with no nurse's initials.
*One error of numbers written in the wrong column with arrows to show where they should have been documented.
*None of the above listed errors had the correction documented in the next line.

Review of the provider's October 2018 Controlled Substance Storage, Distribution, and Documentation for Patient Areas policy revealed:
*Two nurses should have conducted a medication verification count at the end of each shift and both nurses should have signed-off on the controlled substance log.
*When a dose had been administered the nurse administering the medication should have recorded that administration on the form.
*"If an error is made, one line shall be drawn through the error and the nurse shall proceed to the next line."

5. Interview on 8/15/19 at 1:45 p.m. with pharmacist H revealed:
*She agreed the count of Versed vials on the vascular lab was incorrect.
*She had concentrated on the Fentanyl count and had not looked at the Versed count.
*Diversion of Fentanyl would have triggered a look at Versed.
*They were not required to monitor Versed but had chosen to.
*The controlled substance logs were reviewed by pharmacy technicians.
*The pharmacy technicians should have been reviewing to make "sure everything is matching up." The review should have caught:
-Incorrect running total for medications listed on the controlled substance log, incorrect documented wastage, and incorrect methods of documenting errors.
-A pharmacist would not have reviewed the controlled substance logs unless the technicians identified discrepancies. They would then forward the questionable sheets to her or another pharmacist for review.
-Since the incident (potential drug diversion/drug tampering) she "wanted eyes on everything."
-She had "went back and audited through April and May, Nothing was amiss."
-She nor the technicians had identified the incorrect entries and inappropriate documentation corrections listed above on the controlled substance logs.
-Staff correcting errors should have drawn a line through the incorrect entry and put their initials by that entry; not scribbled out the entry.
*Staff should have been sending the controlled substance logs for the cath lab and vascular lab to the pharmacy daily.
*There were times when pharmacy had to request those sheets.