HospitalInspections.org

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Based on observation, interview and review of facility documents, the Governing Body failed to ensure adequate and safe operations of pharmacy services for patients.

Failure to do so created risk for patient harm.

Findings:

Reference: Tags 084, 490, 491, 492, 501 and 502.
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Based on interview, the facility failed to demonstrate that the Governing Body assumed responsibility for ensuring the quality of the delivery of contracted services.

Failure to do so created risk that contractor services provided may be unsafe and/or ineffective.

Findings:

1. On 10/19/2016 at 9:00 AM the Interim Director of Environmental Services (Staff Member #1) from a contract agency (since February 2016) was interviewed about the cleaning schedule and activities of environmental services staff in the Pharmacy. S/he stated that s/he was a new (of 3 weeks) staff member and was not oriented to the Pharmacy area needs.

The Interim Director worked for a newly contracted company that assumed responsibility for management and training of existing environmental services staff. When asked if s/he had ever been to the Pharmacy area, s/he stated no. When asked to describe the state of cleanliness, s/he described it as "horrible". S/he also confirmed that the environmental services supervisor did not have the pharmacy on her/his list for oversight. Subsequently at 10:00 AM, s/he stated s/he was unclear about the process to routinely clean the pharmacy.

2. On 10/20/2016 at 10:30 AM, the surveyor interviewed the System Vice President for Operation (Staff Member #28) about the delivery of contract services. S/he verified that the facility staff had a system for evaluating contract services. However, the governing body's role in ensuring those services were delivered in a safe and effective manner had not been defined, including the contracted environmental services.
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Based on observation, interview and document review, the facility failed to meet the needs of patients through ensuring safe medication practices, especially related to the management of hazardous drugs and ensuring overall environmental safety measures pertaining to medications.

Failure to do so created risk that patients may be harmed.

Findings:

Reference Tags: 492, 501 and 502.
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Based on interview and document review, the facility failed to demonstrate that it implemented timely actions to ensure safe and effective pharmaceutical services, including sterile compounding environments.

Failure to do so created risk that patients may be harmed.

Findings:

A. Pharmacy Construction Plans and Re-model to USP <797> Compliance

1. On 10/20/2016 at 2:00 PM the surveyor and technical advisor interviewed the Director of Pharmacy (Staff Member #15) about development plans for the Pharmacy. S/he stated that remodel construction plans for sterile compounding were approved for the 2014-2015 budget (end date June 2015).

Some daily patient care operations began on 10/19/2016 in re-modeled PeaceHealth Southwest Medical Center pharmacy space. The next step was to implement all sterile compounding activities in the new space, anticipated to occur the 2nd week on November.

2. On 10/20/2016 at 10:30 AM, Chief Financial Officier (Staff Member #29) stated that an organizational priority for a new electronic medical record was implemented and "went live" in August 2015. The state Department of Health approved pharmacy construction plans in November 2015. The PeaceHealth System considered the ongoing risk of concurrent timing of organizational change. In January 2016, the PeaceHealth System re-prioritized pharmacy re-model timing to ensure inclusion of all system pharmacy upgrades and fund approval occurred at that level in March 2016. In April 2016, the remodel at PeaceHealth Southwest Medical Center began.

B. Environment of Care Rounds

1. On 10/26/2016 at 3:30 PM the surveyor interviewed the Director of Safety and the Safety Coordinator (respectively, Staff Members #11 and #12) about Environmental Safety Rounds. The Director of Safety stated that the Pharmacy was categorized as a "non-patient care area" and therefore rounds were conducted once a year. Rounds were last conducted in the Pharmacy in November 2015.

Additionally, s/he stated that there was no policy and procedure related to how the rounds were conducted however s/he described the usual participants which included, but were not limited to, staff from environmental services and infection prevention. S/he noted that Infection Prevention staff did not attend safety rounds in November 2015 and that there was no follow-up system to conduct activities.

2. In review of a document of Environmental Safety Rounds for the Pharmacy in November 2015, it was noted the Infection Prevention was not present. Additionally, flooring was identified as needing to be scrubbed and under "Furniture and Equipment are clean and not damaged: " it stated, "around equipment needs to be detail cleaned." The facility could not provide evidence that the identified items were addressed in 2015 and there was no record of related work orders or communication directly with pharmacy staff.

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Based on observation, review of policy and procedure and interview, pharmacy management and administration failed to ensure a clean, safe and appropriate environment for activities required to execute pharmaceutical services to patients.

Failure to do so created risk to the quality of pharmaceutical services and may result in patient harm.

Findings:

A. General Main Pharmacy

1. On 10/18/2016 at 10:15 AM the surveyor and technical advisor toured the Pharmacy clinical areas. The cleanliness of the physical environment was noted as follows:
a. Floors were visibly dull with the appearance of having not been cleaned for an extended time period. In some locations, they contained a large amount of dust, especially where equipment had previously been located. Staff were observed using whisk brooms to clean floor debris in those areas.

b. Debris and general smudging was observed on the work counter surfaces including, but not limited to, an area where non-sterile oral medications were being compounded on a temporary basis for patients.

c. Carpeting had moderate to large amounts of debris on it and supplies were stored on the carpeting including, but not limited to, an unlocked emergency open heart [drug] kit.

d. The sink immediately adjacent to the sterile compounding area had surface build-up of film, especially on the inner surface and around the handles.

d. An antiseptic solution for handwashing (Hibiclens) was located for use in the bottom of the hand hygiene sink (immediately adjacent to the sterile compounding area) and it was wet with splashed water from prior hand hygiene (not clean for use).

e. The room immediately adjacent to the sterile compounding room had a several large-sized, disclored notice papers and a poster board (with devices posted on it) taped to cabinets. This rendered the surfaces under them not cleanable.

f. Plastic doorway hanging strips that served as partial barrier for staff pass-through from the general pharmacy to the supply-hand washing area for sterile compounding were visibly soiled with splatter spots and had a cloudy appearance.

g. Plastic doorway hanging strips that served as partial barrier for staff pass-through from the supply-hand washing area to the sterile compounding room were visibly soiled with splatter and had a cloudy appearance.

h. Supplies were stored on the floor including, but to limited to distilled water and a box of rags (for undeterminable use).

i. The eyewash station in the supply area (next to the sink) and just prior to the sterile compounding room was in the open position and discolored with fluid and dust.

j. The floor in the sterile compounding area was discolored and dull.

k. Staff beverages and food items were located in the work area (order verification space) where medications were handled by staff for delivery to patient care areas

l. A white plastic bag was partially taped as a barrier to protect a printer from debris during construction. Construction had ceased over a week before. The dusty, partially secured barrier was still in place, contiguous to the pass-through window to the supply-hand washing room immediately adjacent to the sterile compounding area.

B. Pharmacy Drug Storage Annex Environment

1. The general environmental conditions were noted as follows on 10/18/2016 at 11:00 AM:

a. The hand washing sink was heavily stained with debris and rust. It served as a hand hygiene sink and a staff break area sink with several items (including cleaning supplies) in a crowded position to the sink edge.

b. The carpeting had a significant amount of debris on it.

c. Some dust was located on racks and on packaged medication and intravenous fluid bags overwraps.

d. Cardboard boxes, some half-emptied, were located immediately adjacent to medications that had already been unpacked from cardboard boxes and were stored in containers in open wire racks.

e. There was no alcohol-based hand sanitizer available for staff use during handling of medications and supplies.

2. a. On 10/19/2016 at 9:00 AM the Interim Director of Environmental Services (Staff Member #1) from a contract agency (Xanithos since February 2016) was interviewed about the cleaning schedule and activities of environmental services staff in the Pharmacy. S/he stated that s/he was a new staff member (of 3 weeks) and was not oriented to the Pharmacy area needs.

The Interim Director worked for a newly contracted company that assumed responsibility for management and training of existing environmental services staff. When asked if s/he had ever been to the Pharmacy area, s/he stated no. When asked to describe the state of cleanliness, s/he described it as "horrible". S/he also confirmed that the environmental services supervisor did not have the pharmacy on her/his list for oversight. Subsequently at 10:00 AM, s/he stated s/he did not know about the system for routine pharmacy cleaning.

b. On 10/19/2016 at 10:15 AM, a pharmacist (Staff Member #2) was interviewed by the surveyor. S/he stated that the environmental services staff took out the garbage, vacuumed once a week, did not mop the floors but did sweep them.

c. At 10:20 AM, a pharmacy technician (Staff Member #3) was interviewed by the surveyor. S/he stated that environmental services staff took out the garbage and recycling, but s/he had not observed vacuuming or cleaning of surfaces. S/he stated that they "sweep" in the "IV room" [sterile compounding room], and that there was no mopping in that space before the remodel and "now" it was done most days but not every day.

d. At 11:00 AM the Infection Preventionist (Staff Member #4) was interviewed by the surveyor and described the pharmacy as a "high risk" area and observed level of cleaning as "inadequate" for that activities occurring there. S/he relayed that environmental services was assigned cleaning every day but there was "no documentation".

Additionally, s/he stated records indicated that vacuuming was not an assigned task.

e. On 9/26/2016 at 8:30 AM a pharmacist (Staff Member #5) was interviewed about environmental services cleaning activities in the in the pharmacy. S/he started that there were a lot of recent staff changes and described coverage as sporadic. S/he stated that they emptied the garbage cans but there was not consistent mopping or vacuuming.

f. On 10/19/2016 at 2:45 PM, an environmental services staff member (Staff Member #21) stated that s/he had been asked by a infection prevention staff member to clean the pharmacy area. S/he completed vacuuming with non-HEPA filtered vacuum. When asked to rate level of dirtiness of the carpeting, s/he rated it as 10 out of 10 in severity; and rated the floor as 7 of 10 in severity.

g. On 10/19/2016 at 2:45 PM in an interview with the Pharmacy Director (Staff Member #15), s/he indicated that the pharmacy staff was trained to and had planned to assume responsibility from environmental services staff for cleaning the sterile compounding room. However, the pharmacy staff did not start those activities and environmental services was not notified to resume cleaning functions in the sterile compounding room. The result was that no one was assigned to clean the floor in the sterile compounding room.

3. According to a set of pharmacy records, the floor in the sterile compounding room was not recorded as cleaned 11 of 21 days from 9/23/2016 to 10/13/2016. There were similar omissions in documentation related to garbage can cleaning and garbage removal in the sterile compounding area.

In review of other daily EVS cleaning records it was determined that there was no documentation the general pharmacy patient care area had been cleaned by environmental services staff from September 6, 2016 to October 19th, 2016, except for the weekend of September 25. Additionally, the clinical pharmacy area (prescription verification area and supply-handwashing area) were not listed as a work area on the environmental services daily task checklist for Monday through Friday.

4. In review of the current training document titled, "Environmental Services New Hire Guide" pages 11-14 it addressed cleaning the "Pharmacy Compounding/IV Room (USP 797)".

According to the interim Director of Environmental Services (Staff Member #1), environmental services staff had not been trained to perform those function and Environmental Services policies and procedures were not available for the Pharmacy area.

5. a. On 10/22/2016 at 12:00 PM the surveyor noted that there was no documentation of cleaning having occurred in the annex drug storage area since from 10/19/2016 when cleaning issues were initially identified by the surveyor. Additionally, the sink in the room contained staff drinking bottles.

b. On 10/26/2016 at 12:00 PM and subsequent to initiation of Immediate Jeopardy, the interim Environmental Services Manager (Staff Member # 1) stated s/he was not aware that the drug storage annex area was part of the Pharmacy and that there was no documentation that it had been cleaned to date.

C. Hand Washing Fixtures

1. On 10/21/2016 at 11:15 AM the surveyor observed that there was not a general handwashing sink in the main pharmacy area for staff use other than the sink used by staff assigned to the existing space outside the sterile compounding space and the newly constructed anteroom (both not positioned/available for routine access). A general hand washing sink in the Pharmacy had been unavailable to staff since August 2016 as a result of a re-modeling project.

2. a. On 10/21/2016 at 11:15 AM, the surveyor interviewed a pharmacy technician (Staff Member #7) about how s/he accessed a sink for needed hand washing during the work day. S/he stated she used the sink in a restroom (B1-516) located in a hallway outside of the hospital proper (in leased space).

Later at 2:45 PM the surveyor interviewed another pharmacy technician (Staff Member #8), s/he stated s/he used the B1-516 restroom (same location) for needed handwashing. Subsequently, the surveyor interviewed the 2 other pharmacy technicians (Staff Members #9 and #10) who stated that they washed their hands in various location outside of the pharmacy, including restrooms, as there was no sink available for general staff hand hygiene located inside the pharmacy.

3. Upon observation at that above time, it was noted that the sink in B1-516 had build-up of film on the handle and base and there was dark discoloration on white porcelain.

Later on 10/26/2016 at 11:15 AM in a follow-up observation of the same sink , the surface looked similarly. It was determined then that the restroom cleaning at that location was managed by a different contractor than the one that cleaned the hospital and there were no cleaning records available.
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Based on observation, interview, USP <797> and facility documents, the facility failed to demonstrate that it adhered to environmental and practice standards required to adequately perform sterile compounding of drugs.

Failure to do so created risk that compounded medications may cause patient harm related to substandard quality.

General Reference: USP <797>, Official 8/1/16

A. Handling of Hazardous (HD) and Non-Hazardous (NHD) Drugs

Refererence: Responsibility of Compounding Personnel; Hazardous Drugs as CSPs; Environmental Quality and Control-Facility Design and Environmental Controls, Placement of Primary Engineering Controls

Findings:

1. On 10/18/2016 between 10:00 - 11:00 AM in the Main Pharmacy, the surveyor and technical advoisor observed that HD and NHDs were both stored on an open wire rack and in the refrigerator outside of the sterile compounding space. Greater than 50 boxes of HDs were located on the wire rack and located next to sterile compounding supplies. Small staging bins used to HD and NHD were co-mingled without interval cleaning. Similarly, medications delivered to the pharmacist after compounding were placed in trays that were not designated for HD or NHD items.

Later that day between 1:30 - 2:30 PM in the Oncology Infusion Center the surveyor and the technical advisor observed that HD and NHDs were co-located in the segregated compounding room and were being compounded in different hoods within the same room. They also observed that HD and NHDs were handled by staff on different sides of the same staging table (within inches of each other).

2. On 10/19/2016 at 2:45 PM, the Director of Pharmacy (Staff Member #15) stated that administration tried to separate HD and NHD drugs through an outsourcing business agreement with another site but multiple attempts had been unsuccessful. The Director stated s/he had not considered moving all HDs and related activities to the Oncology Infusion Center due to the structural inadequacies of that space (considered less adequate than the main pharmacy).

B. Sterile Compounding Environment

Reference: Responsibility of Compounding Personnel; Hazardous Drugs as CSPs; Low-Risk Level CSPs with 12 hour or Less BUD; Environmental Quality and Control-ISO Class 5 Air Sources, Buffer Areas, and Ante Areas, Facility Design and Environmental Controls, Placement of Primary Engineering Controls; Pressure Differential Monitoring

Findings:

1. On 10/18/2016 at 10:15 AM during an initial tour of the main pharmacy, the surveyor and technical advisor observed that the area was renovated to secure a USP 797 compliant environment for sterile compounding. Construction of the new anteroom and separate hazardous and non-hazardous compounding spaces had been completed and space certification was in process. The plans included relocating all HD compounding from the Oncology Infusion Center to the Main Pharmacy.

2. On 10/18/2016 at 10:15 AM during the tour the Director of Pharmacy (Staff Member #15) stated that the anticipated start date for pharmacy sterile compounding operations within the new USP 797 compliant physical space was planned to occur in a few weeks.

In the interim days, the active compounding environments in the Main Pharmacy and the Oncology Infusion Area were occurring without compliance with USP 797 until the new space was operational.

The existing compounding space did not include room separation between the general pharmacy environment and ISO classified spaces, appropriate pressure differentials/monitoring devices and HEPA filtered air into the ISO spaces with required air exchanges. Also the biological safety cabinets used for HD compounding were not vented to the outside.

C. Aseptic Compounding Technique

Reference: Responsibility of Compounding Personnel; Additional Personnel Requirements; Cleaning and Disinfecting the Compounding Area; Personnel Cleansing and Garbing; Low-Risk Level CSPs with 12 hour or Less BUD [beyond use dating]

Findings:

1. On 10/19/2016 at 9:30 AM the surveyor and technical advisor observed a pharmacy technician (Staff Member #16) in the Main Pharmacy performing compounding sterile compounding as follows:

a. S/he performed those activities for greater than 30 minutes in succession without a glove change. Additionally, sterile gloves for staff use were not located inside the sterile compounding area for needed availability.

b. The technician was observed compounding 5 bags of an intravenous antibiotic at the same time. The bags were lined up in the hood and after they were compounded, patient labels were applied in immediate succession. This activity was considered batching and not permissible under the existing environmental conditions.

2. On 10/26/2016 at 3:15 - 3:45 PM, the technical observed a pharmacy technician (Staff Member #26) perform sterile compounding in the Main Pharmacy. The staff member did not use sterile alcohol solution to disinfect sterile gloves before re-entering the ISO-5 environment inside the hood. S/he also did not perform a sterile glove change after greater than 30 minutes of continuous sterile compounding activity.

3. On 10/18/2016 at 3:00 PM, the surveyor and technical advisor interviewed the pharmacist in the Intensive Care Unit pharmacy space about sterile compounding practices. S/he stated that s/he occasionally prepared emergency medications in the hood located there. When asked about cleaning practices s/he stated the exterior of the hood was not cleaned. A bottle of cleaning solution was determined not to be sterile (required) and was unlabeled (isopropyl alcohol). The stock container for isopropyl alcohol was stored under the sink (not considered clean storage).

D. Personal Protective Equipment

Reference: Responsibility of Compounding Personnel; Additional Personnel Requirements; Standard Operating Procedures; Personnel Cleansing and Garbing

Findings:

1. On 10/26/2016 at 3:15 - 3:45 PM, the technical advisor observed a pharmacy technician (Staff Member #26) perform sterile compounding in the Main Pharmacy. The staff member did not have her/his gown secured over most of her/his back and to the extent that the front of right shoulder was not covered while inside the ISO-5 environment of the hood.

2. On 10/18/2016 at 11:00 AM an outpatient pharmacist (Staff Member #20) was observed to enter and exit the sterile compounding room of the main pharmacy in street clothes without wearing any protective attire, including a beard cover.

3. On 10/18/206 at 2:15 PM pharmacy technician (Staff Member #23) was observed in the segregated compounding room of the Oncology Infusion Center wearing a protective gown in a manner the exposed most of her/her back and the front area of her/his right shoulder.

4. On 10/18/2016 at 10:45 AM, a pharmacy technician (Staff Member #19) was observed was observed with exposed jewelry (a necklace) from under her/his gown.

E. HAND HYGIENE

Reference: Responsibility of Compounding Personnel; Standard Operating Procedures;
Personnel Cleansing and Garbing

Findings:

On 10/18/2016 between 10:15 - 11:00 AM the surveyor and technical advisor observed the following:

a. In an effort to communicate with another staff member, a pharmacist (Staff Member #17) touched the plastic strips hanging in the doorway between the interior main pharmacy and the supply-handwashing area (preceeding the sterile compounding room).

S/he also touched uncleaned plastic strips hanging in the doorway between the that area and the sterile compounding room. S/he did not perform hand hygiene before or after touching the strips and then proceeded to computer use and to handle injectable antibiotic medication to be delivered from the pharmacy for administration to an inpatient newborn.

b. A pharmacist (Staff Member #18) was observed licking her/his fingers twice while working on drug order verification tasks. S/he did not clean her/his hands and then proceeded to other pharmacist tasks.

c. Hand sanitizer was not available for staff use in the annex drug storage area of the pharmacy during a period of time when the sink and sink controls in that location were grossly soiled and covered with a dull film.

F. Pharmacist Supervision of Pharmacy Technician Sterile Compounding

Reference: Responsibility of Compounding Personnel; Finished Preparation Release Checks and Tests-Inspection of Solution Dosage Forms and Review of Compounding Procedures, Physical Inspection; Determining Beyond-Use Dates

Findings:

1. In review of facility job description titled, "Pharmacist" (Last modified 3/10/2015), item 9 stated, "Supervise and train pharmacy technicians to assure accurate order entry, preparation and proper technique. Under job summary it stated, "This position is responsible for performing all necessary functions to ensure optimal use of medications to achieve specific outcomes that improve a patient's quality of life."

In review of facility job description titled "Pharmacy Technician" (Modified 2/25/2016) under "Job Summary" it stated, "Under the direct supervision of a licensed pharmacist, this position is responsible for performing supportive clerical and technical tasks to assist the pharmacist in providing pharmaceutical care."

There was no language in either job description addressing adherence to USP 797 sterile compounding practices.

2. On 10/18/ 2016 at 10:45 AM, the surveyor and technical assistant observed 2 pharmacists in the Main Pharmacy manage oversight of an order for newborn injection of Penicillin G. The initial pharmacist (Staff Member #17) utilized computer systems to verify the order and components of the technician's actions. A second pharmacist completed at double check of those actions. There was no direct observation by either pharmacist of the compounding process by the pharmacy technician (Staff Member #19) for this higher risk (newborn) compounding session.

3. On 10/20/2016 at 8:45 AM, the surveyor interviewed a pharmacist (Staff Member #5) about pharmacy technician supervision. S/he stated that s/he does not perform interim or direct observation of technician practices unless the medication is pediatric, high risk or chemotherapy. S/he planned to implement visual observation of the process when the new sterile compounding environment became operational.

4.a. In review of pharmacy technician annual evaluations, the surveyor noted that 4 of 4 pharmacy technician evaluations (Staff Members# 16, 22, 23 and 24) a registered pharmacist had not conducted any part of the evaluation process. Per the documentation, the evaluations were completed solely by the Pharmacist Technician Supervisor (Staff Member #25).

4.b. On 10/27/2016 at 10:30 AM during an interview with the surveyor and the Pharmacy Technician Supervisor (Staff Member #25) s/he indicated that s/he independently conducted annual evaluations of the pharmacy technicians.
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Based on observation, interview and review of policy and procedure, the facility failed to demonstrate that the pharmacy adequately secured emergency medications.

Failure to do so creates risk that patients may be harmed by poor quality medications and/or the lack of availability of medications.

Findings:

1. a. On 10/20/2016 at 3:25 PM, the surveyor interviewed a Central Supply (CS) staff person (Staff Member #13) about the role of Central Supply department in stocking emergency crash carts. S/he described that pharmacy staff brought a tray of drugs to Central Supply that was fully wrapped in clear plastic. CS staff kept an unsecured key in the department and used it to access a metal supply cabinet. They stored medication trays in that cabinet once the tray was handed off to them by pharmacy staff. The trays were locked by CS staff and placed in crash carts when needed. There was a variation on this plan for pediatric drug trays.

1.b. In review of the policy titled, "Medication Security" (Policy #: NSG-2205; Effective 11/5/2015) it stated that medication shall be secured from "unauthorized personnel". It did not address handling of medications by Central Supply staff and those staff were not licensed accordingly.

2.a. In review of facility policy titled, "Pharmacist Code Box Procedure" (#7170.104.1; revised 02/11) item C. 2. A. 4. stated, "Lock box and record lock number on the code box tracking log".

2.b. On 10/21/2016 at 10:30 AM during a tour of the Emergency Department, the surveyor and technical advisor observed a pediatric code box and adult code box located in the locked medication room. Both medication boxes did not have a securing plastic lock in place.

2.c. During an interview at that time the pharmacist (Staff Member #14) stated that s/he opened one of the boxes and handed it (unused) to another pharmacist. S/he concluded that the second pharmacist had not placed another lock on it as s/he requested. S/he did not have information about the tracking log and had no information about the circumstances of the other unlocked code box.