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Based on observations, a review of hospital documentation, policies and interviews, it was determined that the hospital failed to meet the Condition of Participation for Governing Body. The findings included:

1. The Governing body did not ensure that services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance identified include: Pharmaceutical Services. Refer to A-283, A-490, A-492, and A-501.


2. The Governing body failed to function effectively to ensure that culture testing was conducted in the offsite Intravenous (IV) Infusion Center by Company #1 (contracted service) prior to the initiation of compounding medications and/or failed to ensure that the contracted company provided quality services (Refer to A-83) and/or that mold/fungus growth that required the discontinuation of compounding was reported to the Governing body for review.

a. The infusion center was opened by the hospital on 9/4/14. Review of hospital documentation failed to provide evidence that culture testing was conducted in the isolator prior to the initiation of compounding. Review of the environmental reports and interview with the Director of Pharmacy and the hospital's microbiologist on 8/18/15 at 10:10 AM identified they were not aware that culture testing should have been conducted in the isolator prior to the initiation of compounding to ensure the area was free of organisms and/or mold.

b. Review of environmental testing completed by company #1 (contracted service who provided environmental testing) during the period of October 2014 through June 2015 for the off-site IV Infusion Center rooms where compounding was conducted in an isolator, identified mold growth in various areas within the room in both air and surface sampling. Mold growth was identified in October, November, and December of 2014 additionally in January and February of 2015. Twenty nine colonies of bacterial growth were also identified on a surface area in the negative pressure room in January of 2015. No actionable issues were identified on March 5th 2015 however mold was identified again on 3/12/15, 4/30/15, and on 5/28/15 in the room where the isolators were located. On June 25th 2015 mold was identified in the antechamber of the isolator in the negative pressure room. Tests results were provided to the facility on 6/30/15 and intravenous compounding ceased operation at the infusion center on that day. Interview with the Director of Pharmacy on 8/18/15 at 10:00 AM indicated the compounded sterile preparations (CSP) were couriered over from the main hospital campus so that services would not be interrupted, however, a standard operating procedure for the transport and transfer of the CSP's had not been developed. Subsequent to the surveyor's inquiry the facility developed a written procedure for the transportation of CSP's that included monitoring of the temperature to ensure the efficacy of the medication was maintained.

c. Review of the culture results and interview with the Director of Pharmacy and the hospital's microbiologist on 8/18/15 at 10:10 AM indicated that testing within the isolator was only conducted in one area within the unit and in one area of the antechamber. The Director of Pharmacy and the microbiologist identified they were not aware that additional sampling within the isolator/antechamber was necessary to be considered a comprehensive sample in accordance with USP 797.
d. Review of the facilities documentation failed to identify from October 2014 to April 2015 that the agar type (Trypticase Soybean Casein or Sabouraud Dextrose Agar) contained neutralizers for the surface samples as required by USP 797.

e. Further review of the facility documentation failed to identify a lot number and expiration date on the EM testing reports from October 2014 to Dec 2014 and/or the incubation dates from October 2014 to July 23, 2015.

f. On 4/30/15 and 5/28/15 mold was identified in both the negative and positive pressure room in both surface and air sampling. The action plan was to assess if the air flow had been adjusted, discuss a HEPA filter upgrade, to obtain a hood peridox sporicidal cleaner to use daily on the counter tops, and terminal cleaning with an alternate bleach product. The Director of Pharmacy indicated he was not aware if the air flow was adjusted, and the new HEPA filtration system that was proposed had not been accepted to date of this interview.

g. Interview with the Manager of Clinical Quality/Regulatory Affairs and the Director of the Pharmacy on 8/24/15 identified from September of 2014 through March of 2015 Company #2 was utilized for daily cleaning of the compounding rooms. The hospital failed to demonstrate that a surveillance program was in place to ensure quality services were provided subsequent to the identification of mold growth in the compounding rooms.

h. In March of 2015 the daily cleaning company was changed to a Company #3, a hospital grade company to assess for improvements with mold and bacteria cultures within the positive and negative pressure rooms. Interview with the Manager of Clinical Quality/Regulatory Affairs and the Director of the Pharmacy on 8/24/15 identified from March of 2015 through June of 2015 the facility failed to demonstrate that a surveillance program was in place to ensure quality services were provided subsequent to the identification of mold growth in the compounding rooms.

i. Interview with the Manager of Clinical Quality/Regulatory Affairs and the Director of Pharmacy on 8/24/15 indicated that hospital staff provided the terminal cleaning which included all surfaces in the compounding rooms with the exception of the isolators. The hospital failed to provide evidence that staff who performed the cleaning were trained and/or the type of cleaning products/supplies utilized were documented. Further interview with the Manager of Clinical Quality/Regulatory Affairs stated that surveillance was not completed to ensure terminal cleaning was conducted properly.

j. Interview and tour of the compounding rooms with the Director of Engineering on 8/17/15 at 10:45 AM identified the negative and positive pressure rooms failed to have a thermostat to ensure the temperature of the room was within an acceptable range for medications to be stored. Medications were transferred to the main hospital pharmacy on 6/30/15. Interview with the Facilities Director and the Director of Pharmacy indicated on 7/1/15 they were informed the air conditioning unit in the infusion center was turned off at night and on the weekends. During the period of 9/4/14 through 6/30/15 the facility failed to have a mechanism in place to monitor the temperature of the rooms were the medications were stored to ensure efficacy of the medications were maintained in accordance with the manufacturers recommendations. Subsequent to the surveyors inquiry the facility implemented a procedure entitled Monitoring Medication Room Temperatures.

k. Interview with the Manager of the Infusion Center and the Director of Engineering identified the Infusion Center failed to have generator and did not have a plan if the power source was absent for the compounding areas. Subsequent to the surveyors inquiry an operating procedure entitled Power Outage was implemented that directed in part that the property manager of the facility would notify the manager of the infusion center and the Director of the Pharmacy of any power outage to assess and determine if medications need to be transported to the main campus of the hospital.

l. Interview and tour of the compounding rooms on 8/17/15 at 11:00 AM with the Director of Engineering failed to identify pressure senor alarms or alarms for the exhaust fan were present in accordance with hospital policy. Review of the hospital policy entitled IV Room Infection Control directed in part that both the IV room and the barrier isolators would be monitored and alarmed for proper pressure range. If the alarms sounded, the hospital facilities department would be contacted.
Interview with the Director of Engineering on 8/20/15 at 4:00 PM identified he was responsible to ensure a thermometer, pressure senor and exhaust fan alarms were present in the positive and negative pressure rooms and a plan for a power outage and did not.

Review of the job description for the Director of Engineering identified his/her responsibilities in part directed the management of the physical plant, electrical and medical gas delivery systems, emergency generators and project management. In addition the Director of Engineering supervises general contractors, evaluates locates and recommends equipment and systems for replacement or upgrades, provides oversight for the development and implementation of an overall emergency management strategy for the hospital, applies practical knowledge for the operation of air conditioning and heating systems and meets with contractors to plan, organize, coordinate and communicate programs, services policies and procedures.

m. During an interview on 8/18/15 at 10:30 AM, the Director of Pharmacy, the hospital's microbiologist and the Director of Facilities indicated they had meetings each time culture results were received with the Director of Environmental Services to discuss the mold/bacteria issues in the Infusion Center however, documentation did not support this. An interview with the Director of Environmental Services was unable to be scheduled as he was on a medical leave.

n. During interview on 8/18/15 at 10:40 AM, the hospital microbiologist and the Director of Pharmacy identified mold issues were discussed at each monthly infection control meeting in the attendance of MD #1 who was the infection control physician. MD #1 indicated on 8/18/15 at 4:39 PM he was not aware that mold even in small amounts exceeded the USP 797 threshold. Further interview with MD #1 and the hospital microbiologist indicated that speciation was not conducted until January of 2015 and would be important for identification of the bacteria/mold to determine an appropriate action plan. MD #1 and the hospital microbiologist could identify why the speciation was not conducted from September through December of 2014. Review of the infectious disease physician's duties and responsibilities included to oversee the infection control department.

Interview and review of the Governing Body Minutes from September 2014 through June 2015 with the Chief Nursing Officer (CNO) on 8/24/15 at 1:00 PM identified the Chief Medical Officer (CMO) presented the report of the Quality and Safety Committee minutes to the Governing body however the minutes failed to reflect any acknowledgement that during that period of time, the hospital's outpatient infusion center had grown mold within the compounding areas that exceeded the USP 797 guidelines. In addition the minutes failed to reflect the infusion center ceased compounding on 6/30/15 due to mold in the antechamber of the isolator. Further interview with the CNO indicated he did not inform the Governing body of the positive cultures in the infusion center as remediation was in place and although compounding operations ceased on 6/30/15 patient care was not interrupted.

Interview with the CMO on 8/24/15 at 1:10 PM indicated he was not aware that the positive culture results in the infusion center exceeded USP 797 thresholds and/or that compounding had ceased in that area as of 6/30/15. The CMO indicated that he would have expected to be notified.

Review of the hospital's Pharmacy and Therapeutics Committee functions in part directed to advise the medical staff and hospital administration in all matters pertaining to the use of drugs.

Based on observation, review of facility documentation, interviews and policy review, the Governing Body failed to ensure that quality services were rendered by contracted company's to conduct environmental testing and/or certification of the compounding rooms and/or that staff recognized that reports submitted by numerous company's were complete/accurate. The findings included:

a. The infusion center was opened by the hospital on 9/4/14. Review of hospital documentation failed to provide evidence from September 2014 through December 2014 that the compounding rooms were negative and positive.


b. Review of the report dated 8/20/15, submitted by Company #4, to the Director of Engineering identified that the positive pressure room did not meet the minimum requirement in USP797. The room had only 0.012 of pressure and the minimum requirement is 0.02. Also, it was found that the negative pressure room was drawing air into the room from the return in the ceiling. The Director of Engineering failed to respond to the abnormal report.


Review of the certification report test dated 9/2/14, provided the following information:

c. As per the manufacturer, there are 2 supply and 2 exhaust HEPA filters (total of four) in the CACI. The test report documented that only leak tested one HEPA filter and listed the exhaust as non-applicable. There was no way to determine if the other three were leak tested before compounding began inside the CACI (chemotherapy hood).

d. There were two chambers to the isolator with two gauges showing the pressure in each chamber (ante chamber or the pass through and compounding chamber). Only the barrier isolator pressurization or compounding chamber was documented in the certification.

e. The pressure measured inside the isolator is listed as 0.34 inches of water column. A CACI is used for chemotherapy compounding and is a negative pressure isolator as seen in the physical inspection on 8/17/15 where the dials for both the chambers read negative pressure. But the report lists the pressure inside as positive pressure and incorrectly lists the manufacturer specifications as 0.01.

f. The alarm assessment test is marked as not applicable. Since there is an alarm on the CACI, there is no reason given that it was not tested.

g. The certification does not list if it was done under dynamic conditions as required under USP797.

h. Under overall certification, the box for fail is crossed off. The pass box is filled in. There is a note that there is an issue with the units magnehelic gauge which measures the pressure inside the isolator.

i. The report shows that 4 HEPA filters were leak tested-2 exhaust and 2 supply filters. According to the manufacturer there is only one supply filter. The certification does not match the manufacturer specifications.

j. The alarm assessment test is marked as not applicable. Since there is an alarm on the CAI for low pressure, there is no reason given that it was not tested.

k. The pressure test indicates a negative 0.38 inches of water column in the barrier isolator and the pass through. This is a CAI which is a positive pressure isolator therefore the pressure should not be negative. Even the manufacturer specifications are listed incorrectly as negative 0.02 for both the chambers.


l. The certification does not list if it was done under dynamic conditions as required under USP797.

m. The pre-filters of the isolators are changed every 3 months. The CACI pre-filters are dated 3/25/15 of when they were changed but there is no date on the CAI prefilters. This is done by an outside vendor that also does changes the filters in the entire hospital. There is no way to determine when the prefilters at the off-site infusion center were changed since the invoices are done by listing all the filters changed and does not provide specifically where these filters are located.

Interview with the Director of Pharmacy on 8/18/15 indicated when the certifications reports were issued, hospital staff failed to identify the aforementioned abnormalities and/or contacted company #5 (certified the isolators). At the time of this inspection, there was no report showing if the CAI had even passed certification when compounding was started on 9/4/15.

Based on a review of hospital documentation, interviews and policies, the hospital failed to develop quality performance improvement activities regarding high risk area's including the IV infusion center (offsite location). The finding includes the following:

The infusion center was opened by the hospital on 9/4/14. Review of environmental testing completed by Company #1 (contracted service who provided environmental testing) during the period of October 2014 through June 2015 for the off-site IV Infusion Center rooms where compounding was conducted in an isolator, identified mold growth in various areas within the room in both air and surface sampling. Mold growth was identified in October, November, and December of 2014 additionally in January and February of 2015. Twenty nine colonies of bacterial growth were also identified on a surface area in the negative pressure room in January of 2015. No actionable issues were identified on March 5th 2015 however mold was identified again on 3/12/15, 4/30/15, and on 5/28/15 in the room where the isolators were located. On June 25th 2015 mold was identified in the antechamber of the isolator in the negative pressure room. Tests results were provided to the facility on 6/30/15 and intravenous compounding ceased operation at the infusion center on that day.

a. Review of the Infection prevention committee meeting minutes during the period of September 2014 through June 2015 failed to indicate that surveillance activities were conducted subsequent to the identification of mold growth. Review of the the infection prevention committee functions in part. determines the mechanism for effective surveillance for hospital-acquired infections. Cultures would be conducted whenever necessary for environmental or patient surveillance. Recommendations for corrective actions would be implemented whenever necessary.

Based on a review of hospital documentation, policies and interviews, it was determined that the hospital failed to meet the Condition of Participation for Pharmaceutical Services. The findings included:

1. The hospital failed to ensure the Pharmacy department was in compliance with federal and state laws (USP-797) and/or that the Director recognized questionable performance standards provided by contracted services that provided environmental testing and certification at the IV infusion center from 9/4/14 through 6/30/15. Refer to A-492 and A-501.

Based on observation, review of facility documentation, contractor reports, interviews, and policy review, the hospital failed to provide the necessary supervision of Pharmacy services to ensure that IV compounding rooms were tested/certified in accordance with federal and state laws (USP-797) and/or that culture testing was conducted prior to the initiation of compounding and/or that culture testing was comprehensive and/or that inaccurate reports were recognized and addressed. The findings include:


The infusion center was opened by the hospital on 9/4/14. Review of reports completed by Company #1 (contracted service who provided environmental testing) during the period of October 2014 through June 2015 for the IV Infusion Center rooms where compounding was conducted in an isolator, identified mold growth in various areas within the room in both air and surface sampling. Mold growth was identified in October, November, and December of 2014 additionally in January and February of 2015. Twenty nine colonies of bacterial growth were also identified on a surface area in the negative pressure room in January of 2015. No actionable issues were identified on March 5th 2015 however mold was identified again on 3/12/15, 4/30/15, and on 5/28/15 in the room where the isolators were located. On June 25th 2015 mold was identified in the antechamber of the isolator in the negative pressure room. Tests results were provided to the facility on 6/30/15 and intravenous compounding ceased operation at the infusion center on that day.

a. Review of hospital documentation failed to provide evidence that culture testing was conducted in the isolator prior to the initiation of compounding. Review of the environmental reports and interview with the Director of Pharmacy and the hospital's microbiologist on 8/18/15 at 10:10 AM identified they were not aware that culture testing should have been conducted in the isolator prior to the initiation of compounding to ensure the area was free of organisms and/or mold.

b. Interview with the Director of Pharmacy on 8/18/15 at 10:00 AM indicated the compounded sterile preparations (CSP) were couriered over from the main hospital campus when compounding ceased, so that services would not be interrupted, however, a standard operating procedure for the transport and transfer of the CSP's had not been developed. Subsequent to the surveyor's inquiry the facility developed a written procedure for the transportation of CSP's that included monitoring of the temperature to ensure the efficacy of the medication was maintained.

c. Review of the culture results and interview with the Director of Pharmacy and the hospital's microbiologist on 8/18/15 at 10:10 AM indicated that testing within the isolator was only conducted in one area within the unit and in one area of the antechamber. The Director of Pharmacy and the microbiologist identified they were not aware that additional sampling within the isolator/antechamber was necessary to be considered a comprehensive sample in accordance with USP 797.

d. Review of the facilities documentation failed to identify from October 2014 to April 2015 that the agar type (Trypticase Soybean Casein or Sabouraud Dextrose Agar) contained neutralizers for the surface samples as required by USP 797.

e. Further review of the facility documentation failed to identify a lot number and expiration date on the EM testing reports from October 2014 to Dec 2014 and/or the incubation dates from October 2014 to July 23, 2015.

f. On 4/30/15 and 5/28/15 mold was identified in both the negative and positive pressure room in both surface and air sampling. The action plan was to assess if the air flow had been adjusted, discuss a HEPA filter upgrade, to obtain a hood peridox sporicidal cleaner to use daily on the counter tops, and terminal cleaning with an alternate bleach product. The Director of Pharmacy indicated he was not aware if the air flow was adjusted, and the new HEPA filtration system that was proposed had not been accepted to date of this interview.

g. Interview with the Manager of Clinical Quality/Regulatory Affairs and the Director of the Pharmacy on 8/24/15 identified from September of 2014 through March of 2015 Company #2 was utilized for daily cleaning of the compounding rooms. The hospital failed to demonstrate that a surveillance program was in place to ensure quality services were provided subsequent to the identification of mold growth in the compounding rooms.

h. In March of 2015 the daily cleaning company was changed to a company #3, a hospital grade company to assess for improvements with mold and bacteria cultures within the positive and negative pressure rooms. Interview with the Manager of Clinical Quality/Regulatory Affairs and the Director of the Pharmacy on 8/24/15 identified from March of 2015 through June of 2015 the facility failed to demonstrate that a surveillance program was in place to ensure quality services were provided subsequent to the identification of mold growth in the compounding rooms.

i. Interview with the Manager of Clinical Quality/Regulatory Affairs and the Director of Pharmacy on 8/24/15 indicated that hospital staff provided the terminal cleaning which included all surfaces in the compounding rooms with the exception of the isolators. The hospital failed to provide evidence that staff who performed the cleaning were trained and/or the type of cleaning products/supplies utilized were documented. Further interview with the Manager of Clinical Quality/Regulatory Affairs stated that surveillance was not completed to ensure terminal cleaning was conducted properly.

j. Interview and tour of the compounding rooms with the Director of Pharmacy and the Director of Engineering on 8/17/15 at 10:45 AM identified the negative and positive pressure rooms failed to have a thermostat to ensure the temperature of the room was within an acceptable range for medications to be stored. Medications were transferred to the main hospital pharmacy on 6/30/15. Interview with the Facilities Director and the Director of Pharmacy indicated on 7/1/15 they were informed the air conditioning unit in the infusion center was turned off at night and on the weekends. During the period of 9/4/15 through 6/30/15 the facility failed to have a mechanism in place to monitor the temperature of the rooms were the medications were stored to ensure efficacy of the medications were maintained in accordance with the manufacturers recommendations. Subsequent to the surveyors inquiry the facility implemented a procedure entitled Monitoring Medication Room Temperatures.

k. Interview with the Director of Pharmacy, the Manager of the Infusion Center and the Director of Engineering identified the Infusion Center failed to have generator and did not have a plan if the power source was absent for the compounding areas. Subsequent to the surveyors inquiry an operating procedure entitled Power Outage was implemented that directed in part that the property manager of the facility would notify the manager of the infusion center and the Director of the Pharmacy of any power outage to assess and determine if medications need to be transported to the main campus of the hospital.

l. Tour of the compounding rooms on 8/17/15 at 11:00 AM and interview with the Director of Pharmacy and the Director of Engineering failed to identify pressure senor alarms or alarms for the exhaust fan were present in accordance with hospital policy. Review of the hospital policy entitled IV Room Infection Control directed in part that both the IV room and the barrier isolators would be monitored and alarmed for proper pressure range. If the alarms sounded, the hospital facilities department would be contacted.

Review of the hospital's Pharmacy and Therapeutics Committee functions in part directed to advise the medical staff and hospital administration in all matters pertaining to the use of drugs.

Review of the job description for the Director of Pharmacy included in part the initiative to acquire knowledge, to stay currently informed in the area and fields which are applicable to this position. Works collaboratively with other departments to meet the needs of the hospital.