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Based on observations and staff interviews, the facility failed to ensure that medications available for patient use were appropriately stored.

This failure created the potential for the administration of unsafe medications.

FINDINGS:

FACILITY POLICY

According to facility policy, Multi-Dose Vial Outdate, effective 02/20/14, all multidose vials will be labeled with an orange pharmacy label and dated the date of "first puncture" and 28 days after. Nurses will check all vials in clinic rooms on a daily basis and are responsible for discarding medication vials that are outdated. Nurses will check for any vials that physicians may have opened to make sure they are labeled appropriately.

REFERENCE

According to the Association of Professionals in Infection Control and Epidemiology (APIC), Safe Injection, Infusion and Medication Vial Practices in Healthcare, published July 30th, 2009, dispose of opened multidose medication vials 28 days after opening, unless specified otherwise by the manufacturer. Date opened multidose vials to reflect the date opened and/or the date of expiration.

1. During a survey, ending 02/21/14, the facility was cited with failure to ensure that multidose medications vials were stored and labeled appropriately. The facility submitted a Plan of Correction attesting that the following corrective measures would be implemented by 03/21/14:

All multi-dose vials will be labeled with orange pharmacy labels depicting the date of first use and the applicable 28-day Outdate Dates.

Each staff nurse now has the responsibility of checking all vials in their assigned rooms on a daily basis, effective 3/19/14. Any outdated stock will be disposed of through proper procedures. Nurses will also check for daily usage by Medical Staff in order to monitor for that possibility.

As a double-check measure, one of the full-time nurses has been assigned the duty to check each room on a weekly basis effective 3/19/14.

The latest changes were enacted 3/19/14, and the Clinic Nurse Supervisor is charged with monitoring for compliance.

The Registered Nurse responsible for medication reconciliation will routinely discard unused portions of the multi-dose vials upon their respective expiration dates.

On 04/10/14, a revisit survey was conducted to evaluate the facility's implementation of their Plan of Correction. Survey findings revealed the facility failed to implement appropriate corrective measures as set forth below.

2. On 04/10/14 at 2:55 p.m., a tour of 14 patient examination and procedure rooms was conducted with the Administrator and the Clinic Manager.

Observation during the tour revealed 7 of 14 rooms contained open and undated multidose medication vials, multidose vials with illegible dates, and multidose medications that had not been discarded after 28 days, per the facility's policy.

Exam room #9 contained 1 vial of multidose Xylocaine open and not dated. According to the Clinic Manager, this room was used for patient care on 04/10/14, and s/he had no way of knowing when the medication was opened.

Exam room #1 contained 1 vial of multidose Xylocaine and 1 vial of multidose Kenalog both open and not dated.

Exam room #7 contained 1 vial of multidose Marcaine and 1 vial of multidose Kenalog with a date written on each vial, but illegible as some of the writing was wiped off. The Clinic Manager stated this room was used for patient care on 04/10/14.

Exam room #10 contained 1 vial of multidose Marcaine, dated 03/07/14, which the Clinic Manager stated was out of date, per the facility's policy. One vial of multidose Xylocaine and 1 vial of multidose Kenalog were found open and dated but the date was not legible on either vial. The Clinic Manager stated s/he could not read the dates on these two vials and because of this, the vials should have been discarded. The Clinic Manager stated the room was used for patient care on 04/10/14 and the Marcaine dated 03/07/14 should have been discarded by the nurse who checked the room the morning of 04/10/14, per the facility's plan of correction.

On 04/10/14 at 4:45 p.m., the Clinic Manager stated when s/he looked further in examination room #10, s/he found another multidose vial of Marcaine and a multidose vial of Xylocaine, both dated 03/11/14, which the Clinic Manager stated was out of date and should have been discarded by the nurse who checked the room the morning of 04/10/14. The Clinic Manger stated s/he also found another vial of multidose Kenalog open and not dated.

Exam room #14 contained 1 vial of multidose Xylocaine and 1 vial of multidose Marcaine, both open and not dated.

Exam room #8 contained 1 vial of multidose Xylocaine and 1 vial of multidose Kenalog, both open and not dated. One vial of epinephrine was found open with a date written on it was was not legible. The Clinic Manager stated because the date was not legible, the medication should have been discarded.

The treatment room contained 1 vial of Xylocaine dated 2/19/14, which the Clinic Manager stated was out of date and should have been discarded.

3. Interviews with staff were conducted from 04/10/14 through 04/11/14.

a) On 04/10/14 at 3:30 p.m., an interview was conducted with Registered Nurse (RN) #1 who stated s/he knew about the orange labels to be placed by nursing staff on multidose medication vials. RN #1 stated s/he received sheets of orange labels from the pharmacy "before the surveyors left," referring to the State survey conducted in February, 2014, and placed them in the injection room, which was examination room #8. S/he stated nurses were instructed, while the surveyors were still present in February, 2014, to start using the orange labels and to complete the labels with the day the medication was opened and 28 days later. RN #1 stated s/he placed an orange label on a multidose vial once, then stopped using the labels. When asked why s/he was not placing orange labels on multidose vials, RN #1 stated, "I don't know why I was not using them."

RN #1 stated s/he checked the medications for examination room #7 the morning of 04/10/14, and was aware there were two vials of multidose medications that had dates written on the vials that were not legible. RN #1 stated s/he could "read some of the numbers of the dates" but because s/he could not read the full date written on the vials, s/he should have disposed of the medications. RN #1 stated the date written on the sides of multidose medication vials represented the date the medication was opened and, per the facility's policy, should be discarded 28 days later. RN #1 stated every examination room was not checked every day but only on the mornings the room was scheduled to be used.

RN #1 showed the surveyor a sheet of orange labels located in examination room #8 that contained 50-60 pre-printed labels. The labels were located on a counter top near the container where nurses placed expired medications to be disposed of by the pharmacy staff.

b) On 04/10/14 at 3:40 p.m., an interview was conducted with RN #2 who stated s/he did not know about the orange labels and was not instructed to use them. RN #2 stated s/he was instructed once at the nurses station to write the "open" date on the multidose vials, and that the vials would be discarded 28 days after being opened. RN #2 stated this instruction occurred sometime after the State survey was conducted in February, 2014. RN #2 stated every examination room was not checked every morning, only on the mornings rooms were scheduled to be used.

c) On 04/1/14 at 3:45 p.m., an interview was conducted with RN #3 who stated s/he had never seen the orange medication labels and had not been instructed to use them. S/he stated nurses were instructed "when surveyors were still here" to start dating the multidose vials with the open date by writing the date on vials with a pen. RN #3 stated nurses were instructed once of this new process and that no further training or education of nursing staff had been conducted. When asked who placed the open dates on multidose vials, RN #3 stated the nurses did but at times the RN might not be in the room when a physician opened and accessed a multidose medication. RN #3 stated if s/he noticed an open, undated multidose medication since the morning check was conducted, s/he would ask the physician if they had opened the medication and s/he would then place the open date on the medication. RN #3 stated s/he has had to do this in order to ensure all medications are appropriately dated. RN #3 stated rooms were checked by nurses in the mornings, prior to seeing patients in an examination room and were not checked again at the end of the day.

d) On 04/10/14 at 5:05 p.m., an interview was conducted with the facility's Administrator and the Clinic Manager. The Administrator and the Manager stated the Clinic Nurse Manager was responsible for carrying out the plan of correction related to dating multidose medication vials. Both stated they were not aware the orange labels were not being used by nursing staff, and in lieu of using the labels, that there were multidose medication vials found with no open dated written on them. The Manager stated the medication vials with illegible dates should have been discarded by nursing staff. The Manager stated s/he was not aware only the rooms scheduled to have patients each day were checked by nursing staff instead of each room being checked each day. The Manager stated this made it more difficult to determine when a vial was opened and who on staff opened a vial, as days could go by with a room not being used.

The Manager confirmed that some rooms had expired medications, longer than 28 days, in a room that had been used on 04/10/14 (examination room #10), the date of the revisit, and these medications should have been discarded at least on the morning of 04/10/14 if not prior.

e) On 04/11/14 at 1:36 p.m., a phone interview was conducted with the Clinic Nurse Manager, the Clinic Manager, and the Chief Financial Officer. The Nurse Manager stated s/he developed the plan of correction regarding the dating of multidose medications. When asked why the orange labels were not being used by nursing staff, and that some nurses interviewed had no knowledge of the labels, s/he stated when it came time to implement the use of the orange labels, the clinic physicians "took the stand that they would not change their practice" regarding labeling or dating multidose medications. The Nurse Manager clarified further and stated this meant the physicians would not write open dates on these medications and would not use the labels. The Nurse Manager stated s/he did not inform the Administrator or the Clinic Manager of these statements by physicians. The Nurse Manager stated s/he felt "caught in the middle" between administration and the physicians and so did not implement the plan of correction as submitted to the Department and did not ensure it was being carried out by nursing staff. Upon review of the plan of correction with those present on the call, it was agreed the plan of correction was to be carried out by nursing staff, not by physicians.

When asked how s/he instructed nursing staff that they were responsible for activities contained in the plan of correction, the Nurse Manager stated s/he "told RNs to write the open dates on multidose vials." The Nurse Manager stated s/he instructed nurses in February, 2014, when the survey was still going on and s/he did not instruct nurses to use the orange labels. The Nurse Manager stated s/he held no further training or education of nursing staff on this issue. S/he confirmed again the use of the labels was part of the plan of correction and was submitted to administration. The Nurse Manager stated s/he could not say why multidose medication vials were found open with no open date written on them. When asked again what kept the labels from being used, the Nurse Manager stated, "they just were not."

The Nurse Manager stated the plan of correction was not carried out by the facility as presented to the Department and that it was his/her responsibility. The Clinic Manager stated s/he had no knowledge there were issues with the plan of correction being carried out by nursing staff but stated the plan of correction was not implemented and monitored by the facility.