HospitalInspections.org

This condition is not met as evidenced by:

Based on observation, review of hospital and pharmacy documentation, hospital committee meeting minutes, hospital corrective action plans, e-mail communications, hospital policies and procedures and staff interviews, the hospital failed to ensure that intravenous solutions and/or chemotherapeutic agents were compounded in preparation rooms that were free of recurrent actionable levels of microbial growth.


The hospital failed to ensure that the Pharmacy Department was in compliance with federal and state laws including United States Pharmacopeia Chapter 797 (USP-797), failed to coordinate an ongoing investigation of causative factors related to recurrent actionable levels of microbial growth in viable air samples in multiple compounding areas, failed to ensure implementation of successful remediation.

Please refer to A501

Based on tour of the pharmacy department, review of hospital documentation and interviews the hospital failed to ensure that pharmacy staff was adequately trained and/or that infection control practices/policies were followed, and/or failed to ensure the successful remediation of actionable levels of microbial growth. The findings include:

A tour of the pharmacy on 10/28/14 at 10:45 AM with the Pharmacy Manager identified an anteroom between the main pharmacy and the "sterile" Intravenous (IV)/Chemotherapy preparation room. The anteroom contained a 4 foot by 4 foot area adjacent to the main pharmacy door identified by red tape lines. On the back of the door located in the "dirty" area were two hooks hanging side by side. One hook was labeled MONC (Medical Oncology) and the other hook was labeled IV (Intravenous). The area was considered to be the "dirty" area of the anteroom. The remainder of the anteroom was considered to be the "clean" area of the room. Staff located in the sterile IV Preparation Room included PT#1 who was preparing chemotherapy medication and PT#2 who was preparing IV medications.

During the tour of the anteroom on 10/28/14 at 10:45 AM with the Pharmacy Manager, Pharmacy Technician (PT) #2 exited from the sterile IV Preparation room into the "dirty" area of the anteroom and proceeded to remove his/her personal protection equipment (PPE). The PPE consisted of disposable gown, gloves, mask and protective shoe coverings. PT#2 then proceeded into the "clean" area of the room without protective shoe coverings on and disposed of his/her gloves, mask and protective shoe coverings into the trash. Upon surveyor inquiry the Pharmacy Manager indicated that according to PPE application and removal practices PT#2 should not have stepped into the "clean" area of the room without shoe coverings on and therefore would be reeducated on the practices.

Upon removal of PPE PT#2 proceeded to hang his/her used disposable gown on the identified IV hook on the door. The second hook on the door, labeled MONC contained a disposable gown. Upon surveyor inquiry PT#2 indicated the disposable gown labeled MONC was used by PT#1 to place over his/her uniform when leaving the pharmacy for break. PT#2 further indicated when he/she returned to the anteroom he/she would reapply the IV gown from the hook and enter the sterile IV Preparation room. Facility policy for Aseptic Technique, Including Personal Cleansing and Garbing indicated each time the sterile products area is exited; the gowns will be turned inside out, hung outside the sterile products room and reused for that shift only. However the policy did not indicate what area of the anteroom, clean vs. dirty, each gown should be hung in order to prevent cross contamination.

Review of the microbiology results of surfaces monitored in the sterile IV Preparation room and anteroom were conducted. The surface results identified from June 12 to June 16, 2014 gram positive rods and cocci were present, July 17 through July 21, 2014 gram positive cocci and gram negative rods were present, and August 21 through August 23, 2014 gram negative rods and gram positive cocci were identified. Although the microbiology results indicated the organism species the organism genus was not identified. Facility policy for Environmental Monitoring of Compounded Sterile Products identified any Colony Forming Unit (CFU) should be identified to at least a genus level.

During a review of the IV room and anteroom surface results with the Infectious Disease (ID) Director on 10/29/14 at 1:25 PM he/she indicated that when a cultured sample has identified CFU's there is not usually a genus identified from the culture, as lab does not process the sample to the genus level. However he/she indicated at an Infection Control Committee meeting on 10/29/14 at 1:00 PM it was decided that from this point forward all growth will be cultured to the genus level.

In addition to the above, observation were made on 10/16/14 and 10/17/14, and followed by additional on-site inspections and the following was ascertained:


In April 2013, it was identified that the Department of Pharmacy was not compliant with USP 797 in regards to the physical facility (IV preparation areas) to include: low pressures in the buffer and ante rooms, air exchanges per hour (ACPH) were not completely calculated for the buffer area and the pressures in the ante area were too low and did not meet USP 797 standards, testing was done at rest instead of dynamic conditions as required, there was no certifications of primary engineering controls (PEC), the buffer and ante areas failed certification, did not follow through with recommendations to add additional HEPA filters. Additionally, non compliance of preparing chemotherapy products in the same room as intravenous (IV) products was documented multiple times in the hospital's certification reports (recommendation/ remark).

Multiple observations made in October 2014 (10/16, 10/17) identified that the hospital continued preparing chemotherapy products in the same room as (IV) products. Between April 2013 and December 2014, this practice continued and no physical improvements had been made to the IV preparation areas as identified identified in the certification reports of April 2013.

The hospital reported 1 CFU of mold in the ante area but did not identify that the ante area had non-viable particle counts as high as 85 million as required by public act 14-224. The Biological Safety cabinet (BSC) (Labconco) appeared not to be in original working condition as it was observed to have duct tape wrapped around the exterior frame. In addition, the duct tape was observed to be curling back in certain areas, exposing the sticky/tacky side. Review of hospital documentation identified that the hospital's microbiology consultant recommended to replace this BSC but that did not occur. One BSC was not vented to the outside, which was also noted in April 2013 and had not been corrected. Space was found between the ductwork venting the BSC and the ceiling tiles allowing unfiltered plenum air to move into the room. Duct tape was found on the floor of the buffer area and appeared to be used to repair the integrity of the buffer room floor. There was no pressure monitor from the Ante area to the main pharmacy as required. The drop-down ceiling tiles were noted to be porous therefore could not be cleaned and did not meet USP 797 standards.


In regards to maintaining appropriate pressures in the ante and buffer areas, the only return vent in the Ante room ceiling was taped shut, and several of the return vents in the ceiling in the buffer area are also taped shut. The lights in the ceiling were not enclosed therefore allowing unfiltered plenum air to come into the buffer area. A 55 gallon corrugated box was observed in the buffer area, chairs with exposed stuffing were being used in the buffer area, and other items not used for sterile compounding were found in the buffer area, such as graduated cylinders and cords. Used vials of chemo product waste was observed to be gathered in a plastic bag for disposal but were placed on a counter instead of being disposed of appropriately.


Hospital documentation related to the pharmacy department's certification dated March 2014 was reviewed. The certifier identified that zero CFM's were identified in the ante room, indicating that no HEPA filtered air was entering the room. The ante room failed the pressure differential, there was no leak testing of HEPA filters in the ceiling of the buffer areas, and no smoke studies were conducted on the LAFW. There was a failure by hospital staff to identify the room volume discrepancy between the air balancing report versus the certification report. An accurate room volume is required to calculate the ACPH's in the room. March and October 2014 B&V reports identified the ante area as 400 ft 3 and the buffer area as 960 ft 3. However, in October 2014, Air Balancing Service Inc. identified the ante and buffer areas with different calculations.


In regards to surface and air sampling in 2013, although CFU quantities were identified, there was no further identification of growth during viable air sampling. In 2014, there was no identification to genus level of gram positive cocci in viable air samples and no genus level identification of surface mold in August 2014. The hospital did not provide an action plan and/or analysis by their consultant microbiologist for the September 2014 or October 2014 viable air samples. In addition, viable air and surface sampling data did not include the required data such as incubation temperature, agar type, lot number and expiration date.


In regards to air samples collected, there was a failure to recognize and remediate actionable surface sampling in June 2013 and again in March 2014. In August 2014, actionable levels of microbial growth were identified in a BSC. However, the hospital closed the incorrect PEC for remediation. Documentation identified that the "small chemo hood" was shut down for remediation but the actionable levels of microbial growth were in the "large" chemo BSC.


In regards to gowning and garbing for chemo and IV preparations, a compounding technician identified that non-chemo gowns were worn underneath the chemo gowns so that once compounding chemotherapy agents were completed, the top chemo gown was removed and left on a chair. The technician would then begin compounding IV products wearing the same non-chemo gown. The technician would transition between compounding chemo and IV products using the same two gowns between preparation areas as products were needed. Review of hospital documentation, there were missing/incomplete training documents for staff regarding proper hand washing and garbing. It was also identified that four technicians who failed initial fingertip tests were allowed to continue compounding, with one technician compounding for six months before re-testing occurred. It was identified that staff were using chemotherapy gowns that had a maximum of four hours protection (against various chemotherapy agents) for as long as 8 hours. On physical inspection used gowns potentially contaminated with chemo products were being draped over counters and chairs to be reused by compounding staff.


The hospital was not using closed system vial transfer devices (CSTD) for chemotherapy agents to prevent venting and exposure of hazardous substance into the environment.
In regards to cleaning, the PEC's were only being wiped with 70% sterile isopropyl alcohol (sIPA) and sterile water and no cleaning agents were being utilized on a daily basis. Large vials of single sterile water with chemo pins were being used for both cleaning and compounding with no appropriate labeling. This practice was unknown to the pharmacist in charge, and it continued to be the practice despite managements assurance that they would no longer use this practice.

Based on tour of the pharmacy department, review of facility documentation and interviews the hospital failed to ensure pharmacy staff was adequately trained and/or infection control practices/policies were followed. The findings include:
A tour of the pharmacy on 10/28/14 at 10:45 AM with the Pharmacy Manager identified an anteroom between the main pharmacy and the "sterile" Intravenous (IV)/Chemotherapy preparation room. The anteroom contained a 4 feet by 4 feet area adjacent to the main pharmacy door identified by red tape lines. On the back of the door located in the "dirty" area were two hooks hanging side by side. One hook was labeled MONC (Medical Oncology) and the other hook was labeled IV (Intravenous). The area was considered to be the "dirty" area of the anteroom. The remainder area of the anteroom was considered to be the "clean" area of the room. Staff located in the sterile IV Preparation Room included PT#1 who was preparing chemotherapy medication and PT#2 who was preparing IV medications.
During the tour of the anteroom with the Pharmacy Manager, Pharmacy Technician (PT) #2 exited from the sterile IV Preparation room into the "dirty" area of the anteroom and proceeded to remove his/her personal protection equipment (PPE). The PPE consisted of disposable gown, gloves, mask and protective shoe coverings. PT#2 then proceeded into the "clean" area of the room without protective shoe coverings on and disposed of his/her gloves, mask and protective shoe coverings into the trash. Upon surveyor inquiry the Pharmacy Manager indicated that according to PPE application and removal practices PT#2 should not have stepped into the "clean" area of the room without shoe coverings on and therefore would be reeducated on the practices.
Upon removal of PPE PT#2 proceeded to hang his/her used disposable gown on the identified IV hook on the door. The second hook on the door, labeled MONC contained a disposable gown. Upon surveyor inquiry PT#2 indicated the disposable gown labeled MONC was used by PT#1 to place over his/her uniform when leaving the pharmacy for break. PT#2 further indicated when he/she returned to the anteroom he/she would reapply the IV gown from the hook and renter the sterile IV Preparation room. Facility policy for Aseptic Technique, Including Personal Cleansing and Garbing indicated each time the sterile products area is exited; the gowns will be turned inside out, hung outside the sterile products room and reused for that shift only. However the policy does not indicate what area of the anteroom, clean vs. dirty, each gown should be hung in order to prevent cross contamination.
Review of the microbiology results of surfaces monitored in the sterile IV Preparation room and anteroom were conducted. The surface results identified from June 12 to June 16, 2014 gram positive rods and cocci were present, July 17 through July 21, 2014 gram positive cocci and gram negative rods were present, and August 21 through August 23, 2014 gram negative rods and gram positive cocci were identified. Although the microbiology results indicated the organism species the organism genus was not identified.
Facility policy for Environmental Monitoring of Compounded Sterile Products identified any Colony Forming Unit (CFU) should be identified to at least a genus level.
During a review of the IV room and anteroom surface results with the Infectious Disease (ID) Director on 10/29/14 at 1:25 PM he/she indicated that when a cultured sample has identified CFU's there is not usually a genus identified from the culture. The lab does not process the sample to the genus level. However he/she indicated at an Infection Control Committee meeting on 10/29/14 at 1:00 PM it was decided that from this point forward all growth will be cultured to the genus level.

Based on tour of the pharmacy department, review of hospital documentation and interviews the hospital failed to ensure that pharmacy staff was adequately trained and/or that infection control practices/policies were followed, and/or failed to ensure the successful remediation of actionable levels of microbial growth. The findings include:

A tour of the pharmacy on 10/28/14 at 10:45 AM with the Pharmacy Manager identified an anteroom between the main pharmacy and the "sterile" Intravenous (IV)/Chemotherapy preparation room. The anteroom contained a 4 foot by 4 foot area adjacent to the main pharmacy door identified by red tape lines. On the back of the door located in the "dirty" area were two hooks hanging side by side. One hook was labeled MONC (Medical Oncology) and the other hook was labeled IV (Intravenous). The area was considered to be the "dirty" area of the anteroom. The remainder of the anteroom was considered to be the "clean" area of the room. Staff located in the sterile IV Preparation Room included PT#1 who was preparing chemotherapy medication and PT#2 who was preparing IV medications.

During the tour of the anteroom on 10/28/14 at 10:45 AM with the Pharmacy Manager, Pharmacy Technician (PT) #2 exited from the sterile IV Preparation room into the "dirty" area of the anteroom and proceeded to remove his/her personal protection equipment (PPE). The PPE consisted of disposable gown, gloves, mask and protective shoe coverings. PT#2 then proceeded into the "clean" area of the room without protective shoe coverings on and disposed of his/her gloves, mask and protective shoe coverings into the trash. Upon surveyor inquiry the Pharmacy Manager indicated that according to PPE application and removal practices PT#2 should not have stepped into the "clean" area of the room without shoe coverings on and therefore would be reeducated on the practices.

Upon removal of PPE PT#2 proceeded to hang his/her used disposable gown on the identified IV hook on the door. The second hook on the door, labeled MONC contained a disposable gown. Upon surveyor inquiry PT#2 indicated the disposable gown labeled MONC was used by PT#1 to place over his/her uniform when leaving the pharmacy for break. PT#2 further indicated when he/she returned to the anteroom he/she would reapply the IV gown from the hook and enter the sterile IV Preparation room. Facility policy for Aseptic Technique, Including Personal Cleansing and Garbing indicated each time the sterile products area is exited; the gowns will be turned inside out, hung outside the sterile products room and reused for that shift only. However the policy did not indicate what area of the anteroom, clean vs. dirty, each gown should be hung in order to prevent cross contamination.

Review of the microbiology results of surfaces monitored in the sterile IV Preparation room and anteroom were conducted. The surface results identified from June 12 to June 16, 2014 gram positive rods and cocci were present, July 17 through July 21, 2014 gram positive cocci and gram negative rods were present, and August 21 through August 23, 2014 gram negative rods and gram positive cocci were identified. Although the microbiology results indicated the organism species the organism genus was not identified. Facility policy for Environmental Monitoring of Compounded Sterile Products identified any Colony Forming Unit (CFU) should be identified to at least a genus level.

During a review of the IV room and anteroom surface results with the Infectious Disease (ID) Director on 10/29/14 at 1:25 PM he/she indicated that when a cultured sample has identified CFU's there is not usually a genus identified from the culture, as lab does not process the sample to the genus level. However he/she indicated at an Infection Control Committee meeting on 10/29/14 at 1:00 PM it was decided that from this point forward all growth will be cultured to the genus level.

In addition to the above, observation were made on 10/16/14 and 10/17/14, and followed by additional on-site inspections and the following was ascertained:


In April 2013, it was identified that the Department of Pharmacy was not compliant with USP 797 in regards to the physical facility (IV preparation areas) to include: low pressures in the buffer and ante rooms, air exchanges per hour (ACPH) were not completely calculated for the buffer area and the pressures in the ante area were too low and did not meet USP 797 standards, testing was done at rest instead of dynamic conditions as required, there was no certifications of primary engineering controls (PEC), the buffer and ante areas failed certification, did not follow through with recommendations to add additional HEPA filters. Additionally, non compliance of preparing chemotherapy products in the same room as intravenous (IV) products was documented multiple times in the hospital's certification reports (recommendation/ remark).

Multiple observations made in October 2014 (10/16, 10/17) identified that the hospital continued preparing chemotherapy products in the same room as (IV) products. Between April 2013 and December 2014, this practice continued and no physical improvements had been made to the IV preparation areas as identified identified in the certification reports of April 2013.

The hospital reported 1 CFU of mold in the ante area but did not identify that the ante area had non-viable particle counts as high as 85 million as required by public act 14-224. The Biological Safety cabinet (BSC) (Labconco) appeared not to be in original working condition as it was observed to have duct tape wrapped around the exterior frame. In addition, the duct tape was observed to be curling back in certain areas, exposing the sticky/tacky side. Review of hospital documentation identified that the hospital's microbiology consultant recommended to replace this BSC but that did not occur. One BSC was not vented to the outside, which was also noted in April 2013 and had not been corrected. Space was found between the ductwork venting the BSC and the ceiling tiles allowing unfiltered plenum air to move into the room. Duct tape was found on the floor of the buffer area and appeared to be used to repair the integrity of the buffer room floor. There was no pressure monitor from the Ante area to the main pharmacy as required. The drop-down ceiling tiles were noted to be porous therefore could not be cleaned and did not meet USP 797 standards.


In regards to maintaining appropriate pressures in the ante and buffer areas, the only return vent in the Ante room ceiling was taped shut, and several of the return vents in the ceiling in the buffer area are also taped shut. The lights in the ceiling were not enclosed therefore allowing unfiltered plenum air to come into the buffer area. A 55 gallon corrugated box was observed in the buffer area, chairs with exposed stuffing were being used in the buffer area, and other items not used for sterile compounding were found in the buffer area, such as graduated cylinders and cords. Used vials of chemo product waste was observed to be gathered in a plastic bag for disposal but were placed on a counter instead of being disposed of appropriately.


Hospital documentation related to the pharmacy department's certification dated March 2014 was reviewed. The certifier identified that zero CFM's were identified in the ante room, indicating that no HEPA filtered air was entering the room. The ante room failed the pressure differential, there was no leak testing of HEPA filters in the ceiling of the buffer areas, and no smoke studies were conducted on the LAFW. There was a failure by hospital staff to identify the room volume discrepancy between the air balancing report versus the certification report. An accurate room volume is required to calculate the ACPH's in the room. March and October 2014 B&V reports identified the ante area as 400 ft 3 and the buffer area as 960 ft 3. However, in October 2014, Air Balancing Service Inc. identified the ante and buffer areas with different calculations.


In regards to surface and air sampling in 2013, although CFU quantities were identified