HospitalInspections.org

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A. Pharmacy Technician Supervision by a Pharmacist

Based on review of policy and procedure and interview, the facility failed to ensure that pharmacy technician activities during the sterile compounding process in the main inpatient pharmacy were supervised by a registered pharmacist.

Failure to do so creates risk that the compounded sterile products may cause patient harm.

Findings:

1. In review of facility policy titled, " Pharmacy Ancillary Caregiver Utilization Plan " (Policy #PH-ANC; Effective 06/27/2016) it described the job responsibilities and requirements of pharmacy technicians. Under item 1 it stated, " All work must be performed and checked under the direct supervision of a registered pharmacist. "

2. On 9/22/2016 at 1:00 PM, the surveyor and technical advisor interviewed a pharmacy technician (Staff Member #9) about her/his work duties in the main inpatient pharmacy sterile compounding room (non-hazardous drugs). A portion of the main pharmacy was under remodel and sterile compounding room was in a temporary location with no observation windows. When asked if the pharmacist came into the room during technician compounding practices (for interim supervision), s/he stated no.

This finding was confirmed on 9/23/2016 at 12:30 PM during an interview with a pharmacist (Staff Member #10) who stated that s/he did not go into the sterile compounding room to observe technician activities during compounding processes, except when technicians compounded sterile pediatric products.

3. On 9/22/2016 at 10:00 AM in the Cancer Center, the surveyor and technical advisor observed the pharmacist (Staff Member #2). During that time period s/he did not inspect the final compounded products for quality (i.e. color, clarity and container integrity) prior to making them available for nursing staff for patient administration.

On 9/23/2016 at 12:30 PM in the main pharmacy, the surveyor and technical advisor interviewed the pharmacist (Staff Member #10) twice about how s/he handled compounded products delivered to her/him by technicians. S/he neglected to mention that s/he inspected compounded products for quality (i.e. color, clarity and container integrity) prior to making them available for nursing staff to administer.

B. Staff Training and Demonstrated Competency for Hazardous Drug (HD) Compounding and Use of Equipment

Based on review of the approved Plan of Correction dated 8/12/2016 for the federal complaint investigation dated 6/20/2016, the facility failed to ensure completion of staff training for USP 797 compliance in the Oncology Infusion Center per the timelines identified in the plan of correction and prior to re-initiation of HD compounding the week of September 19, 2016.

Failure to do so, creates risk that standards for sterile compounding of hazardous drugs will not be adhered to and may result in patient harm.

Findings:

1.In review of facility policy titled, " Sterile Compounding " (Policy # ANC-2552; Effective 08/26/2016) it stated, " All personnel who compound or handle hazardous materials undergo safety training before handling materials. . . 1.1.7.1 Personnel willing to prepare hazardous medications will complete the Peacehealth Hazardous Medication Initial Training and Competency Assessment. " The policy went on to describe other items required for training. "

Plan of Correction Appendices D, E, F and F-1 were competency assessment checklists for pharmacist and pharmacist technicians specifically addressing " Hazardous IV Admixtures " .

2. In review of training records of staff engaged in hazardous drug (HD) compounding in the Cancer Center, the following omissions were noted:

a. A pharmacist (Staff Member #1) did not complete the competency titled, " Initial Training and Competency for Hazardous Medication Order Entry and Compounding " (Appendix F) for pharmacists).This pharmacist was a specialized clinical oncology pharmacist and engaged in HD compounding practices a few days of the week.

Two other HD pharmacists (Staff Members #2 and 3) had not completed the competency titled, " Initial Training and Competency Hazardous Medication Order Entry and Compounding " (for pharmacists) after the stated timeline for completion and prior to supervising technicians in HD compounding and managing compounding practices.

b. One of two HD pharmacy technicians (Staff Member #4) had not completed the competency titled, " Hazardous Medication Order Entry and Compounding " (for technicians) after the stated timeline and prior to engaging in HD compounding practices.

c. One of two HD pharmacy technicians (Staff Member #4) had not competed the competency titled, " Initial Training and Competency PH [pharmacy] Cleaning and Disinfection Procedures Audit " after the stated timeline for completion and prior to engaging in HD compounding practices.

d. One of two HD pharmacy technicians (Staff Member #5) was signed off for items on a training/competency checklist titled, " ChemoSHIELD Negative Pressure Isolator " . However, one item was not designated as completed; " Demonstrate glove replacement: decontaminates old gloves first, pull inside out, remove O-ring discard old glove, stretch new glove over plastic flange, replace O-ring, push glove into isolator, sanitize with sterile IPE " . This document also was not dated and did not contain the name and/or signature of the person certifying competency, as also lacking for Staff Member #4.

On 9/22/2016 at 11:15 AM, a pharmacy technician (Staff Member #4) stated to the technical advisor that " gauntlet " gloves in the containment isolator required changing every 3 hours per an equipment instructional video.

e. During an interview with the surveyor and technical advisor on 9/22/2016 at 9:30 AM, a HD compounding pharmacist (Staff Member #2) told the surveyor and technical advisor that he watched the instructional video about the isolator but did not read the required sections of the operations manual.

On 9/23/2016 at 1:00 PM, another HD compounding pharmacist (Staff Member #3) told the surveyor and technical advisor the same information.

3. In review of an email from the Clinical Pharmacy Specialist (Staff Member #1) to pharmacy HD compounding staff dated 9/13/2016 at 2:33 PM (while the Pharmacy Manager-Staff Member #6 and Pharmacy Director-Staff Member #7 were out of town), it stated " We will begin using the IV [intravenous] room and Isolator on September 19. In preparation we need to complete competency training for the new process. " The email further described that " we will need to complete " a training video, Review of Section I and Section III of the isolator operator manual and completing the competency.

It identified the pharmacist managers (inpatient-Staff Member #6 and outpatient-Staff Member #8) as the person to " check us off using the competency tool attached " to the email. (Both pharmacy managers were included in the email.)

The outpatient pharmacy manager (Staff Member #8) had not completed competency in the area of HD compounding. The inpatient pharmacy manager (Staff Member #6) was out of town that week (which also immediately preceded the implementation of HD compounding using a new containment isolator).

4. On 9/23/2016 the Pharmacy Manager (Staff Member #6) stated that the Clinical Oncology Pharmacy Specialist (Staff Member #1) was not assigned responsibility for competency assessment of staff performing HD compounding practices while the Pharmacy Manager and Pharmacy Director were out of town.

During the onsite investigation the Clinical Oncology Pharmacy Specialist (Staff Member #1), the Pharmacy Director (Staff Member #7) and the administrator over Pharmacy Services (Vice President of Professional Services-Staff Member #11) were out of the office and unavailable for interview regarding implementation of decision making for training and HD compounding activities.

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