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Based on observation, interview and record review the facility failed to perform sterile compounding to ensure there were no introduction of contamination.

The findings included:

An observation and interview was conducted on June 5, 2012 from 9:45 a.m. to 10:19 a.m. with Staff #44, Staff #45, Staff #47, Staff #49 and Staff #73. Staff #49 described the operation of the facility's "Clean Room Complex" within the pharmacy. The "Clean Room Complex" is an area utilized for sterile compounding. Staff #49 described the "Clean Room Complex" as five areas each progressing to a higher level of cleanliness and with different air pressures to prevent contamination of the sterile compounding area. Staff #49 reported that cardboard was discarded in the "dirty room" and other outside paper products did not enter the "Clean Room." Staff #49 reported that staff needed to perform specific hand/forearm hygiene and don specific personal protective equipment in order to enter the "Clean Room." Staff #49, Staff #44, Staff #45 and the surveyor entered the pediatric pharmacy in order to observe the "Clean Room" through a set of windows. The observation revealed a staff (Staff #73) sitting at the far end of a table reading a book." An inquiry was made into what Staff #73 was reading. Staff #49 motioned for Staff #73 to pick up the phone within the clean room, Staff #49 directed the surveyor to the phone in the pediatric pharmacy. The surveyor asked Staff #73 about the reading material; Staff #73 reported it was a book brought in from home. The phone in the pediatric pharmacy was handed to Staff #49, who directed Staff #73 to immediately remove the book from the "Clean Room" with the reminder that no outside material should ever come in to the sterile compounding room. Staff #49 reported responsibility for supervision of the "Clean Room Complex." Five other Pharmacy staff working in the sterile environment had failed to redirect Staff #73 and failed to ensure the strict protocols for the "Clean Room" were maintained.
Review of the facility's policy titled "Standard Operation Procedures (SOPs): Clean Room Complex read: "Intravenous admixture orders are prepared by the Pharmacy 24 hours per day/ 7 days a week to provide quality patient care to patients requiring intravenous medication therapy. USP Chapter 797 standards for sterile compounding are followed thoroughly and closely monitored. Procedure: A. Break Down Area 1. When supplies and drug vials are received form [sic] the Pharmacy storeroom (Slab), the cartons of drugs or plastic bag of supplies are removed from the corrugated brown cardboard used for shipping. 2. The cartons of individually packaged vials and/or plastic bag or supplies are placed on the dark blue carts which can be transported to the dirty side ... of the Ante Room ... C. Ante Room 1. Pocketbooks, personal laptop computers, and food or drink can NOT be brought into Ante Room, Buffer Room or Hazardous Drug Room. 2. Chewing gum, drinks, candy, or food items shall not be brought into the Ante Room, Buffer Room or Hazardous Drug Room. 3. Cartons of drug vials and supplies are transferred ... the black transfer cart... 5. All non-hazardous drug vials must be removed from their unit dose packaging (boxes or trays) and either spayed and wiped down with 70% isopropyl alcohol to disinfect and to remove particulate matter at the sink staging area before transfer to the Buffer Area. D. ...24. All procedures are performed in a manner designed to minimize the risk of touch contamination ..."

Based on observation and staff interview, the facility staff failed to ensure that food products were stored under appropriate conditions in the walk-in freezer. The ventilation/cooling fan was leaking causing ice build-up on pans placed by staff underneath the fan system.

The findings included:

During the tour of the kitchen area beginning at 1:05 p.m., on June 5, 2012, the surveyors observed the walk-in freezer. Underneath the ventilation/cooling fan were three large metal sheet pans, which had been placed on the top shelf. There were four large (six inches or greater in height/build-up) areas of ice build-up caused by drippings from the fan unit. Frozen food items were on the shelves underneath these pans.

On June 5, 2012 at 1:50 p.m., Staff/Employee # 32 was interviewed by the surveyor regarding this ice build-up and the placement of the pans. Staff/Employee #2 stated, "The fan is leaking and the staff placed those pans underneath to keep the water from getting on the food. We will have a work order put in for that right away."

On June 6, 2012 at 8:10 a.m., the surveyor was presented with a document which evidenced the work order had been placed on June 5, 2012 at 2:57 p.m. and contained the following, "Follow-up for inspectors. A work order has been placed regarding ice build-up on ceiling fan. Staff had placed the pans underneath the fan to catch any drips that might fall so that it would fall directly into the pans placed there and not on food products until physical plant can follow-up." This document contained the electronic signature of Staff/Employee # 31.

Facility policy "Production, Purchasing, Storage - Food Supply and Storage Procedures" documented, "All food, non-food items and supplies used in food preparation shall be stored in such a manner as to prevent contamination to maintain the safety and wholesomeness of the food for human consumption..."

Based on observations, interviews and document review the facility failed to monitor compliance with all policies, procedures, protocols of their infection control program, maintain of a sanitary physical environment, monitor the disinfecting of environmental surfaces between patient usages and monitor the storage and preservation of food:

1. Facility staff and or vendors were observed wearing surgical attire (scrubs, shoe coverings, mask and head coverings) outside of the surgical area in food service areas.

The vent directly over the cleaned surgical instruments in the sterile processing room was blocked by dust/lint.

An operating room (OR) was cleaned then prepared by the same staff in the same uncovered scrubs.

Items used by different patients could not be properly disinfected due to tears or worn areas in numerous areas.

Staff observed adjusting their hair using the inside of a refrigerator door as a mirror.

There was no air gap on 2 observed ice machines.

2. Pharmacy staff introduced contaminates into the sterile compounding room. Pharmacy staff failed to follow strict protocols within the sterile compounding room.

3. The facility failed to disinfect tables and pads between patients in the radiology area.

4. Food was still available for use with an expired best used by date and there was ice build up under the ventilation fan in the freezer used for patient food storage.

The Findings Include:

1. On June 5, 6 and 7, 2012 while touring the facility and while having lunch in the main dining room of the hospital the following observations and interviews occurred.

On June 5, 2012 at approximately 12:45 P.M., three people were observed sitting at a table in the main dining room. One person (staff/vendor #66) had on a red cloth head covering, surgical scrubs (no cover) and paper foot covers over shoes. The second person (staff/vendor #65) had on surgical scrubs (no cover). The third person who was not identified had on street clothes (shirt and pants). At approximately 1 P.M., staff/vendor #66 and #65 left the dining area and proceeded down the hallway, through a doorway and up a flight of stairs. They next walked into a door that led into a lounge area of surgical suite. They walked through the lounge area and through another door that led into another hallway.

The Interim Director of the OR arrived at approximately 1:20 P.M. and was asked to locate staff/vendor #66 and #65. At approximately 1:35 P.M., staff/vendor #66 and #65 were located in different operating rooms. They each were asked if they had been in the dining room and the response from both was, "I may have been." Staff/vendor #66 was asked if he had on a cloth head covering and paper shoe coverings in the dining room and he stated, "I don't remember." Staff/vendor #66 had on a paper head covering and no shoe covers at this time. Staff/vendor #66 was asked why he had on a cloth head covering in the dining room and he stated, "I was embarrassed by the way my hair looked." When asked where the shoe coverings were he stated, "These are the shoes I always wear." He did not answer about the shoe coverings.

On June 5, 2012 at approximately 1:50 P.M. an observation was made of the staff cleaning OR room 2024 to prepare for the next surgical case. During the cleaning of the dirty linens and surgical covers were removed and the surgical table was wiped down by an OR tech. Once the table was dry the same OR tech placed clean linens on the table to prepare for the next surgical table. The OR tech did not have on protective coverings over his scrubs for either event. At various points during both processes the OR tech's scrubs touched the table. The Interim Director of the OR was observing this and stated, "Maybe we should look at that."

Also in OR room 2024 the surgical table was observed to have worn/torn edges on the seams. The surgical rolling stool had a 2-3 inch tear in the covering. Also in the hallway in the area of rooms used for orthopedic surgeries were devices used during surgery for patient placement. The devices had old tape on them, tape residue and the area where they hung had dust that could be picked up by a person's fingers. The Interim Surgical Director of the OR stated, "I will get that taken care of right away."

On June 5, 2012 during the tour of the surgical area, the ice machine was observed. The drain from the ice machine was below the surface of the floor and did not have an air gap.

On June 5, 2012, a tour of the sterile central supply area was made. The vent directly over the cleaned surgical instruments in the sterile processing room was blocked by dust/lint. The Manager of the area stated, "We just had them clean the vents a week ago."

On June 5, 2012 at approximately 3:30 P.M., the medical director of the operating room was interviewed regarding the wearing of scrubs (uncovered), head covers and shoe covers in various places in the hospital. The medical director stated, "We are in complete agreement with that (scrubs should be covered, head wear should be removed and shoe covers removed when leaving the surgical area and covers removed, head wear and shoe covers (if desired) replaced)."

On June 5, 2012 while touring the neuro ICU area the ice machine was observed. The drain from the ice machine was below the surface of the floor and did not have an air gap. The Health Systems Engineering Manager (HSEM) was interviewed regarding the air gap. The HSEM stated, "The drain can't be hard wired to the drain in the floor. It can not touch the sides of the drain. I was not aware the drain from the ice machine could not be below the floor."

The FDA Food Establishment Plan Review Guide - Section III, Part 12 defines an air gap as the unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or outlet supplying fixture, or other device, and the flood level rim of the receptacle. The vertical physical separation shall be at least two times the inside diameter of the water inlet pipe above the flood rim level, but shall not be less than one inch.
On June 6, 2012 while touring the pediatric ICU (PICU) a shower room, (room #7542) was observed, the vent in the shower room was filled with dust. The Manager of the PICU stated the room was for visitors to use. The room was not labeled for visitors.

On June 6, 2012 at approximately 1:50 P.M. staff #68 was observed in the food selection area of the main dining room area selecting food. Staff #68 was dressed in scrubs (no cover), a cloth head cover and a mask hanging around her neck. Staff #68 was asked where she worked and she stated, "The hybrid area." When asked where the hybrid area was Staff #68 stated, "It's a part of the cardiac cath lab." Staff #68 was asked why she had worn her scrubs, hat and mask into the food serving area and she stated, "It is ok for us to wear scrubs here. I am in anesthesia and we are too busy to change."

On June 7, 2012 at approximately 9:00 A.M. prior to entering the cath lab area a person in surgical scrubs, a mask around the neck and a cloth head covering was observed running down the hallway and entering the cath lab area. The person entered cath lab "B".

On June 7, 2012 at approximately 9:30 A.M., observations were made of the cardiac cath lab and hybrid areas. The Director stated the hybrid room could immediately turn into an operating room where open heart surgery could be performed. During the tour of the cath lab area wheelchairs were observed to have torn/cracked seats exposing porous surfaces leaving them unable to be cleaned after use. The Director of the cath lab stated, "We will need to replace those."

On June 7, 2012 at approximately 11:30 A.M., a staff member who was serving coffee from a vending area of the main dining room was observed opening the refrigerator where milk and other perishable items were stored. The staff member opened the door of the refrigerator, looked into the inside of the door, adjusted her hair and closed the door. She returned to serving coffee with no hand hygiene observed. An observation of the inside of the refrigerator door was made and the inside of the door was mirror like in the reflection it gave off.

On June 7, 2012 at approximately 2:30 P.M., the ambulatory surgical area was observed. There were numerous chairs that could not be cleaned due to torn seats; tape residue was on the key boards, beside tables and crash carts. The Nurse Manager stated, "We will get that taken care of immediately." Also during this observation, a patient was observed being transported to a waiting car via wheelchair.

Once outside the building a member of the transportation staff took over and assisted the patient into the car. The transportation staff returned the wheelchair back to a storage area. The transportation staff stated they did not wipe the chairs down after use, that was the staff's responsibility in the building. No one was observed wiping down the wheelchair. There was no wipes for cleaning items with direct patient contact near the wheelchair storage area.

On June 5, 6 and 7, 2012 numerous (approximately 7-10 within a 1 hour span of time) staff/vendors were observed wearing scrubs (uncovered) head coverings, and some shoe coverings in the food serving and dining areas of the facility.

A copy of the facility policy on Surgical Attire Section S Number 11.0 was provided by the facility staff. The policy was reviewed on 6/7/12 and 6/8/12 and #2 of the content states, "Protective coverings (masks, gowns and shoe covers) are to be removed prior to leaving the surgical area."


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2. An observation and interview was conducted on June 5, 2012 from 9:45 a.m. to 10:19 a.m. with Staff #44, Staff #45, Staff #47, Staff #49 and Staff #73. Staff #49 described the operation of the facility's "Clean Room Complex" within the pharmacy. The "Clean Room Complex" is an area utilized for sterile compounding. Staff #49 described the "Clean Room Complex" as five areas each progressing to a higher level of cleanliness and with different air pressures to prevent contamination of the sterile compounding area. Staff #49 reported that cardboard was discarded in the "dirty room" and other outside paper products did not enter the "Clean Room." Staff #49 reported that staff needed to perform specific hand/forearm hygiene and don specific personal protective equipment in order to enter the "Clean Room." Staff #49, Staff #44, Staff #45 and the surveyor entered the pediatric pharmacy in order to observe the "Clean Room" through a set of windows. The observation revealed a staff (Staff #73) sitting at the far end of a table reading a book." An inquiry was made into what Staff #73 was reading. Staff #49 motioned for Staff #73 to pick up the phone within the clean room, Staff #49 directed the surveyor to the phone in the pediatric pharmacy. The surveyor asked Staff #73 about the reading material; Staff #73 reported it was a book brought in from home. The phone in the pediatric pharmacy was handed to Staff #49, who directed Staff #73 to immediately remove the book from the "Clean Room" with the reminder that no outside material should ever come in to the sterile compounding room. The five other pharmacy staff working in the "Clean Room" with Staff #73 had failed to ensure that outside contaminates were not introduced into the sterile compounding environment.
Review of the facility's policy titled "Standard Operation Procedures (SOPs): Clean Room Complex read: "Intravenous admixture orders are prepared by the Pharmacy 24 hours per day/ 7 days a week to provide quality patient care to patients requiring intravenous medication therapy. USP Chapter 797 standards for sterile compounding are followed thoroughly and closely monitored. Procedure: A. Break Down Area 1. When supplies and drug vials are received form [sic] the Pharmacy storeroom (Slab), the cartons of drugs or plastic bag of supplies are removed from the corrugated brown cardboard used for shipping. 2. The cartons of individually packaged vials and/or plastic bag or supplies are placed on the dark blue carts which can be transported to the dirty side ... of the Ante Room ... C. Ante Room 1. Pocketbooks, personal laptop computers, and food or drink can NOT be brought into Ante Room, Buffer Room or Hazardous Drug Room. 2. Chewing gum, drinks, candy, or food items shall not be brought into the Ante Room, Buffer Room or Hazardous Drug Room. 3. Cartons of drug vials and supplies are transferred ... the black transfer cart... 5. All non-hazardous drug vials must be removed from their unit dose packaging (boxes or trays) and either spayed and wiped down with 70% isopropyl alcohol to disinfect and to remove particulate matter at the sink staging area before transfer to the Buffer Area. D. ...24. All procedures are performed in a manner designed to minimize the risk of touch contamination ..."
3. An observation and interview was conducted on June 5, 2012 from 11:00 a.m. to 12:18 p.m. with Staff #43 and Staff #51. The observation revealed the pad on one of two magnetic resonance imaging (MRI) tables had non-intact surfaces. The pad had tears at the corners and along one side with worn areas on the top surface of the pad. The torn surfaces of the pad allowed for contamination of the underlying foam and prevented disinfection of the pad between patients. One of two MRI tables had multiple layers of tape and sticky substances, which prevented the table from being disinfected between patients. Staff #43 and Staff #51 observed the findings, acknowledged the pad was not intact, and could not be disinfected between patients. Staff #51 reported the tape and sticky substance on the MRI table prevented its disinfection between patients.
An observation and interview conducted on June 5, 2012 from 3:01 p.m. to 3:11 p.m. with Staff #38, Staff #43 and Staff #79 revealed five of five viewed diagnostic radiology tables had torn pads. Staff #79 reported the facility had changed from the "regular" table pads to a "dipped and more flexible pad." The observation revealed the regular pad had worn areas along the sides, the top midsection and at the corners. Four of four observed dipped pads had tears at the corners exposing the underlying foam pad. Staff #38, Staff #43 and Staff #79 observed the findings, acknowledged the pads were not intact, and could not be disinfected between patients.
An observation and interview conducted on June 5, 2012 at 3:30 p.m. with Staff #43 and Staff #39 revealed one of two procedure table pads in the Interventional Neuroradiology (INR) suite was not intact. The observation in procedure room #2 revealed the table pad was torn at the corners and had a worn area on the lower midsection of the top. Staff # 39 observed the findings and reported the risk of cross-contamination between patients related to the inability to disinfect the pad between patients.


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4. During the tour of the kitchen area beginning at 1:05 p.m., on June 6, 2012, the surveyors observed food items that were not dated when opened and expired "half-and half" cream.

At 1:45 p.m., the surveyor observed the following: (1) A white quinova rice bag which had been opened and sealed with clear wrap. This rice had no label/date as to when the product was opened. (2) A rice "Medley" bag which was opened and sealed with clear wrap. No label/date as to when the product had been opened. (3) A 7 lb (pound) 8 oz (ounce) plastic container of "Strawberry Topping" which had been opened with approximately 2/3 (two thirds) of the contents remaining. This item was not dated when opened and the sides of the bottle were streaked to the bottom with sticky residue from the contents. (4) Three quart-sized cartons of half-and-half cream were found with the expiration date of June 4, 12 at 1600 (4:00 p.m.). Staff/Employee (s) #'s 30, 31, and 32 were present and aware of the observations/findings of the surveyors.

Facility policy "Production, Purchasing, Storage - Food Supply and Storage Procedures" documented, in part: "All food, non-food items and supplies used in food preparation shall be stored in such a manner as to prevent contamination to maintain the safety and wholesomeness of the food for human consumption. PROCEDURES: ... Cover, label and date unused portions and open packages. Use the [Name of the company]'s orange label; complete all sections on the label...Discard food past the use-by or expiration date..."