HospitalInspections.org

Based on a review of hospital documentation, policies, and interviews, it was determined that the hospital failed to meet the Condition of Participation for Governing Body as evidenced by:


1. The Governing Body did not ensure that services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance identified include: Quality Assessment and Performance Improvement (QAPI), Pharmaceutical Services, Physical Environment, and Infection Control. (Please refer to A-263, A-283, A-490, A-492, A-501, A-700, A-701, A-726, A-747, and A-749).


2. The Governing body failed to function effectively to ensure reports received from Contamination Control Service Specialists (contracted services) were comprehensive and/or complete. (Please refer to A83) and/or that mold/fungus growth in the IV Infusion Center and hospital Pharmacy were reported to the governing body for review and appropriate action.


a. Based on a review of facility documentation, contractor reports, interviews, and quality plans, the following was ascertained:


Review of reports completed by Company #1 (contracted service who provides environmental testing) during the period of January 2013 through August 2013 for the IV Infusion Center compounding rooms identified mold growth in various areas in air and surface samples. There was mold growth in October, November, and December 2013. No issues were seen in January 2014 but fungi was again seen in February 2014. No issues were seen in April 2014. There was fungi growth in May and June 2014.

The first action plan provided by the Pharmacy Manager is dated 4/10/14 for the mold growth seen in February 2014. The Manager was unable to speak to issues prior to employment date of February 1, 2014. It is a "rolling" plan where items are added but failed to address each specific finding in the contractor reports (refer to A-83 for specific issues). The action plan for 4/10/14 states "passed USP-797 standards but needs corrective action" despite mold growth on surfaces in the ante and chemo buffer areas. There are no action plans seen before 4/10/14.

During interview on 7/17/14 at approximately 5:15 PM, the Pharmacy Manager stated that s/he informed team members in infection control, environment of care and building services of the mold issue in the pharmacy and notified others via email, however, was unable to provide documentation that supported this. The Manager further stated that an action plan was developed that went to the environment of care committee in June 2014 to include HVAC revision, however, no date of work was identified as IV compounding continued at the infusion center until 7/8/14, when the compounding room at the infusion center was closed.

Review of the Environment of Care meeting minutes dated 4/16/2014 and attended by Assistant Vice President (AVP) #1, Director of Engineering, Pharmacy Manager and Infection Control Nurse #1, identified that there were concerns of not meeting the requirements of USP-797 for intravenous compounding secondary to the increasing temperatures greater than 68 degrees Fahrenheit and increasing humidity greater than 70%. An undersized HVAC system had been identified in August 2013, as the cause for the increasing humidity levels.

During interview on 7/22/14 at 12:50 PM, the Director of Engineering stated that the former CEO/VP of Patient Care had been aware of the mold issues. Although the issue of mold had been discussed at several EOC (environment of care) meetings, less expensive changes (i.e.., covering the windows in one room) were made with a plan to address the HVAC system in the future.

b. Review of reports completed by Company #1 & Company #2 (contracted service who provides environmental testing) for the Hospital Pharmacy compounding rooms, identified mold growth in various areas in air and surface samples in February 2013, June 2013, and July 2013, with the February 2013 surface sample at the edge of the BSC.

There were no action plans to show any remediation was completed to address these findings.


The February 2014 samples show an actionable level of CFU's (195) in the ante room sink surface sample. There is no action plan to show any remediation was done to address these findings or re-testing done. As of 7/18/14, no EM tests were done in the room since to ensure that sanitary conditions exist.

Review of the Pharmacy & Therapeutics (P&T) meeting minutes during the period of 1/31/13 through 5/28/14, identified that committee members included in part, VP of Patient Care, AVP #1, ICN #1 and Pharmacy Director. The minutes failed to indicate a concern of mold/fungi growth at the IV Infusion Center and/or hospital pharmacy although members were aware of the issues.


Review of the Infection Control Meeting minutes during the period of 1/13 through 7/14 identified that committee members included in part, ICN #1, Pharmacy Director, MD #2, VP of Patient Care, and environment/engineering representation. The minutes failed to indicate a concern of mold/fungi growth at the IV Infusion Center and/or hospital pharmacy although members were aware of the issues.


Review of the Environment of Care Committee (EOC) minutes during the period of 8/13 through 6/18/14 identified that committee members included in part, Director of Engineering, VP of Patient Care, AVP #1, ICN #1 and Pharmacy Director. The minutes reflected humidity issues at the infusion center pharmacy due to undersized HVAC system and ongoing mold issues. Although the EOC committee reports to the Quality Committee of the Board (members include in part, VP of Patient Care and Pharmacy Director) who in turn report to Governing Body, Quality minutes failed to indicate a problem with mold despite members knowledge of this issue.

Review of the Medical Executive Committee minutes (reports to Governing Body) during the period of 1/9/13 through 5/11/14, failed to reflect any notification from the Infection Control Committee and/or the P&T committee (report to Medical Executive committee) regarding evidence of mold in the environmental testing studies for the pharmacy compounding rooms although members from those committees participated in Medical Executive committee meetings and were aware of the issues.

Review of the Governing Body meeting minutes during the period of 1/14/13 through 6/2/14 failed to reflect any acknowledgement that during that period of time, the hospital's pharmacy and outpatient infusion center had grown mold within the compounding areas of the pharmacy. Although the infusion center had been closed during the month of August to September 2013, in an attempt to remediate the problem of mold growth, the Governing Body narratives failed to reflect an oversight of knowledge and/or conformation of the problem and how it was to be handled despite the fact that the mold growth continued at the offsite infusion center. In addition, minutes failed to reflect commencement of the new contract signed in May 2014 with Company #2, to provide testing and certification services to the pharmacies.

During interview on 7/23/14 at 9:15 AM, AVP #1 stated that he/she was unaware of the mold growth problem until 7/8/14, when the issue was brought to the attention of the CEO and the infusion center was closed for remediation. Review of the Environment of Care (EOC) meeting dated March 19, 2014 identified that the clean room did not pass inspection and AVP #1 questioned if the room was "ok" to use. The EOC meeting minutes dated 4/16/14, reflected that AVP #1 was present when the Pharmacy Manager identified mold/fungus was present in the IV infusion center secondary to high temperatures/humidity/room pressures which did not meet the standards of USP-797 for compounding intravenous solutions.


During interview on 7/16/14 at 9:30 AM, the CEO stated that structural changes have been made within the organization with an expectation that pertinent data be forthcoming in an effort to address significant issues and ensure quality care is delivered.


According to the Corporate Quality Improvement Plan for 2014, financial and medical information is utilized to identify improvement opportunities and support the success of corrective actions.


Review of the Quality Assessment Plan identified that the Board of Directors had the ultimate responsibility for ensuring the quality and effectiveness of patient care services provided by its medical and other professional and support staff.

Based on observation, review of facility documentation, contracted service reports, interviews, and policy review, the Governing body failed to ensure the hospital's Quality program assessed services provided by two contractors' to identify quality and performance issues. The findings include the following:

a. The IV Infusion Center (Enfield location) was opened by the hospital on March 12, 2012. Review of the testing and certification report dated February 12, 2014, completed by Contamination Control Service Specialists, Company #2, identified the following discrepancies:

i-The positive pressure from the IV buffer area to the ante area was too low.

ii-The positive pressure from the ante area to the outside was too low.

iii- The chemo buffer area failed to qualify for ISO7.

iv- The humidity seen in all three rooms ranged from 12.5% to 13.1%.

v-The Room Air Exchange Rate in the ante room incorrectly listed acceptance criteria even though the actual number meets USP-797 standards.

vi-The particle counts for the chemo buffer area noted in two sections of the report (particle counts and in statistical analysis) do not match.


Review of the testing and certification report dated April 2, 2014, completed by Company #2, identified the following discrepancies:

i-Completed a pressure reading between the rooms. The positive pressure from the ante room to the outside was too low.


Review of the testing and certification report dated May 30, 2014, completed by Company #2, identified the following discrepancies:

i-There is no mention if this certification was done under dynamic conditions.

ii-The acceptance criteria for the Room Air Exchange Rate in the ante room was incorrectly listed (the actual number meets the standards).

iii-The ante area is classified as ISO8 even though it should be classified as ISO7 due to chemo buffer area coming off the ante area.


The facility was unable to provide documentation of follow-up or action plans that the above discrepancies were addressed, remediated and/or that re-testing had occurred.


b. Review of the environmental testing, completed by Company #1 during the period of January 2013 through January 2014, identified the following concerns:

i- No temperature or dates of incubation.

ii- Although testing start and completion dates were noted, the report failed to identify dates the samples were taken.

iii- No documentation if the air samples were volumetric impaction collections.

iv- No sampling (air or surface) done in the PEC until December 2013.

v- With the exception of September 2013, no documentation of lot number and expiration dates of the media used. Additionally documentation failed to reflect whether the growth media had neutralizing agents for the surface samples.

iv- The sample plan was incorrect, showing a BSC in the IV buffer room instead of an LAFW.


Review of the environmental testing, completed by Company #2 for the February 2014 and April 2014 reports, identified the following concerns:


i- No temperature or dates of incubation.

ii- February and April 2014 reports had errors showing the ante room as an ISO8 area which changes the colony forming units (CFU) actionable levels.

iii- Additionally, the sampling plan reflects tables where none exist in the ante room (surface sample marked S9). In February 2014, no sink was marked in the ante room but was identified as a table in the sampling plan.


The facility was unable to provide documentation that these errors were addressed.


c. Review of the hospital pharmacy certification reports completed on 7/10/13 and 2/12/14 identified the following concerns:

i- The 7/10/13 report, showed the positive pressure in the ante room to the outside to be 0.01 inches of water column, which was too low (needs to be between 0.02 -0.05 inch of water column) and the room failed under pressurization.

ii- The humidity seen in the buffer area ranged from 89.8% to 93.5% for the four readings taken and 86.5% to 86.9% for the 3 readings done in the ante area (facility standard between 30 and 60%).

iii- The 2/12/14 report, showed the humidity as 8.3% to 8.9% in the ante room and 8.1% to 8.3% in the buffer area. There was no explanation for these numbers and how they compare to the last report.


There was no action plan to identify what was done to correct these issues.


During interview on 7/17/14 at 10:40 AM, the Pharmacy Manager stated he/she began employment on February 1, 2014, therefore the 7/10/13 report would have been addressed to the previous Pharmacy Manager. The Manager indicated that his/her concern with the contractor included communication issues and untimely reports. The Manager failed to recognize issues within the reports that required immediate follow-up to ensure a safe environment was maintained.


During interview on 7/23/14 at 10:20 AM, AVP #1 stated that when a contract was due to be reviewed, it went to quality metrics, a separate group, for a legal review, rather than a quality review prior to renewing the contract.


Review of the corporate structure for committee reporting identified that the Environment of Care and Quality Improvement Committee report directly to the Quality Committee of the Board while all other committees (Infection Control, Pharmacy and Therapeutics) all report to the Medical Executive Committee. According to the Corporate Quality Improvement Plan for 2014, financial and medical information is utilized to identify improvement opportunities and support the success of corrective actions.

Based on a review of hospital documentation, contracted services, policies, and interviews, it was determined that the hospital failed to meet the Condition of Participation for Quality Assessment and Performance Improvement as evidenced by:


1. The hospital failed to integrate its departmental Quality Assessment and Performance Improvement (QAPI) program, specifically contracted services, Pharmaceutical Services and Infection Control, into the hospital wide program when mold was identified in the compounding areas at the IV infusion center and hospital pharmacy dating back to 1/13. (Refer to A-283).

Cross reference A-83, A490 and A747.

Based on a review of hospital documentation, contractors' reports, interviews, and policies, the hospital failed to develop quality performance improvement activities regarding high risk area's including the IV compounding rooms in the Pharmacy and the IV infusion center (offsite location) and/or had an effective reporting structure through the various committees that report to Governing body to ensure appropriate intervention when mold was identified in the IV infusion center dating back to 1/13 and the hospital's pharmacy on 2/13. The findings include the following:


a. Review of reports completed by Company #1 & Company #2 (contracted service who provides environmental testing) during the period of January 2013 through August 2013 for the IV Infusion Center compounding rooms show mold growth in various areas in air and surface samples. The September 2013 sampling was done after a terminal clean of the facility and no issues are seen. There was mold growth in October, November, and December 2013. No issues were seen in January 2014 but fungi was again seen in February 2014. No issues were seen in April 2014. There was fungi growth in May and June 2014.


Review of the hospital pharmacy EM testing reports, performed by Company #1 and/or #2 identified mold growth in various areas in air and surface samples in February 2013, June 2013, and July 2013, with the February 2013 surface sample at the edge of the BSC.


The February 2014 samples show an actionable level of CFU's (195) in the ante room sink surface sample. There was no action plan to show any remediation was completed to address these findings and/or re-testing completed. As of 7/18/14, no EM tests were done in the room since to ensure that sanitary conditions exist.


Review of the Infection Control Meeting minutes during the period of 1/13 through 7/14 identified that committee members included in part, ICN #1, Pharmacy Director, MD #2 (Chairperson), VP of Patient Care, and environment/engineering representation. The minutes failed to indicate a concern of mold/fungi growth at the IV Infusion Center and/or hospital pharmacy although members were aware of the issues. The Infection Control committee failed to institute measures (e.g. surveillance) to remediate mold growth in the Pharmacy compounding rooms.


During interview on 7/18/2014 at approximately 2:20 PM, the Infection Control Nurse (ICN #1) stated that s/he did know of the mold problem at the outpatient infusion center however, did not complete surveillance rounds of the pharmacy compounding room at the IV Infusion center or the hospital pharmacy. ICN #1 further stated that MD #2 (Infectious disease physician) was aware of the mold problem and suggested that it could be coming from the air handling system however, ICN #1 failed to document any suggestions and/or bring the matter before the Infection Control Committee.


During interview on 7/17/14, MD #1 (Medical Director of Infusion Center) stated that s/he was first aware of a mold problem approximately one year ago (August 2013) when the infusion center closed for one month for remediation of the problem. MD #1 stated that the Program Director of the Infusion center notified him/her of the mold growth problem in May 2014, however, was unaware of the plan to remediate of the problem.


During interview on 7/22/14 at approximately 11:30 AM, the Nurse Manager of the IV Infusion Center was unable to recall the exact date s/he was notified of the mold issue but had a peripheral awareness of the issue. The Manager explained s/he was responsible for the Infusion Center and that Pharmacy was a separate department where they obtained medications for their patients'. The Nurse Manager stated there were no formal meetings and/or discussion with the infection control department regarding this issue and/or assessment regarding how this affected the safety of the patients treated at the infusion center.


During interview on 7/22/14 at 10:00 AM, the IV Infusion Center Program Director stated the previous pharmacy Manager had notified him/her of the mold problem, however, was unable to provide an exact date of awareness. The Director stated s/he had notified the Medical Director (MD#1) of the issue in August 2013 when the decision to close the compounding room was made, however, did not contact the Infection Control Department as s/he relied on the experts (Engineering and Pharmacy Manager) to address the issues which included reopening of the compounding room on September 23, 2013. The Director further identified that the previous VP of Patient Care Services (no longer employed at the hospital) was aware of the ongoing mold issues.


b. Review of the Pharmacy & Therapeutics meeting minutes during the period of 1/31/13 through 5/28/14, identified that committee members included in part, VP of Patient Care, AVP #1, ICN #1 and Pharmacy Director (Secretary). The minutes failed to indicate a concern of mold/fungi growth at the IV Infusion Center and/or hospital pharmacy although members were aware of the issues.



Review of a memo dated 3/24/14 to IV Infusion Center staff (signed by 7 staff members) from the Pharmacy Manager identified that based on the mold problem on the walls last year and fungi growth on the chemo and anteroom table during last month (2/14) steps to improve environment controls to minimize fungi/mold growth in the mixing (buffer) rooms must be taken. The Manager and the Microbiologist from company #2 strongly suspect that the HVAC system might be the primary culprit since it is not a dedicated Pharmacy system and temperature and humidity controls are not adequate and this concern is being addressed at the administrative level.

During interview on 7/17/14 at approximately 5:15 PM, the Pharmacy Manager stated that s/he told the team members of infection control, environment of care and building services of the mold issue in the pharmacy and notified others via email, however, was unable to provide documentation that supported this. The Manager further stated that an action plan was developed that went to the environment of care committee in June 2014 to include HVAC revision however, no date of work was identified as IV compounding continued at the infusion center until 7/8/14, when the compounding room at the infusion center was closed.


c. Review of the Environment of Care Committee (EOC) minutes during the period of 8/13 through 6/18/14 identified that committee members included in part, Director of Engineering (Chairperson), VP of Patient Care, AVP #1, ICN #1 and Pharmacy Director. The first notation regarding a concern of mold/fungi growth at the IV Infusion Center and/or hospital pharmacy was dated 4/16/14 with interventions that included, in part, to wipe down all surfaces in the chemo and infusion mixing rooms, all vials and IV bags with IPA (Isopropyl Alcohol), verify floors were properly cleaned at night, staff were to wear new booties everytime they enter the anteroom, removal of cardboard and trash from the area and fix the floor seal. Although the EOC committee reports to the Quality Committee of the Board (members include in part, VP of Patient Care and Pharmacy Director) who in turn report to Governing Body, Quality minutes failed to indicate a problem with mold despite member's knowledge of this issue.

During interview on 7/22/14 at 12:50 PM, the Director of Engineering stated that the former CEO/VP of Patient Care Services had been aware of the mold issues and that s/he had been working to remediate the problem.

During interview on 7/23/14 at 9:15 AM, AVP #1 stated that s/he was unaware of the mold growth problem until 7/8/14, when the issue was brought to the attention of the CEO and the infusion center was closed for remediation. Review of the Environment of Care (EOC) meeting dated March 19, 2014 identified that the clean room did not pass inspection and AVP #1 questioned if the room was "ok" to use. The EOC meeting minutes dated 4/16/14, reflected that AVP #1 was present when the Pharmacy Manager identified mold/fungus was present in the IV infusion center secondary to high temperatures/humidity/room pressures which did not meet the standards of USP-797 for compounding intravenous solutions.


Although members of several committees had knowledge of the mold issues, these members failed to ensure data was incorporated into the Medical Executive Committee and/or Quality Committee of the Board who report directly to the Governing Body.



Review of the Corporate Quality Assessment Plan identified that the Board of Directors had the ultimate responsibility for monitoring all aspects of patient care and safety. The primary goal of the Quality/Performance improvement plan is to systematically plan, design, measure, assess and improve performance of hospital wide key functions and processes relative to patient care and safety; and to improve healthcare outcomes while reducing and preventing errors and preventable adverse outcomes.


d. When asked if the hospital conducted a risk analysis to determine if the positive mold/fungal cultures could potentially impact the health of the patients, interviews with the Director of the Infusion Center and Nurse Manager on 7/22/14 and MD #2 on 7/28/14 failed to reflect that this was done.


On 7/18/14, the hospital arranged for the IV Infusion Center Treatment Room (where patient's received care & services) to be environmentally tested. Review of the report identified that during this testing period, the area (indoor) mold spores were significantly above recommended guidelines and required attention. Possible Causes include: inadequate filtration of the outdoor air, either at the building or test area level and improper building pressurization allowing unfiltered outdoor air to penetrate this space.




16649

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 as evidenced by:


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 the contracted service who provided environmental monitoring/testing/certification at the IV Infusion Center (Enfield campus) and the hospital's pharmacy and/or developed action plans when mold/fungus was identified in the compounding rooms dating back to 1/13. (Please 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 mold growth in the IV compounding rooms dating back to 1/13 was addressed in a timely manner, and/or that quality services were provided by a contracted service. The findings include:


Cross reference A-501


a. The IV Infusion Center (Enfield location) was opened by the hospital on March 12, 2012. The facility was unable to provide evidence that certifications were done when the facility was first opened and prior to compounding. Certification involves airborne non-viable particle counting (determining of ISO classification), airflow testing and smoke pattern test, room pressurization, HEPA filter leak test, general temperature and humidity.

During interview on 7/17/14 at 10:40 AM, the Pharmacy Manager stated s/he started employment on February 1, 2014 and that it was the Manager's responsibility to arrange for any testing required at the facility. The Manager was unable to provide documentation that certification was completed. Interview with AVP #1 on 7/22/14 at 2:00 PM stated the contracted company was contacted and was unable to provide documentation that the room was certified prior to compounding medications as required. Documentation was not provided to the surveyor that identified the date compounding of medications commenced.


b. Review of work orders during the period of 2012 and 2013 identified that floors were fixed and then replaced in the ante area as explained by Director of Engineering on 7/22/14 at 12:50 PM, however, failed to provide documentation that the rooms were certified following this work as required by USP 797. This created the potential for unsanitary conditions that could affect compounding of medications at the Center.


c. Review of reports completed by Company #1 & Company #2 (contracted service who provides environmental testing) during the period of January 2013 through August 2013 for the IV Infusion Center compounding rooms show mold growth in various areas in the air and surface samples. The September 2013 sampling was done after a terminal clean of the facility and no issues are seen. There was mold growth in October, November, and December 2013. No issues seen in January 2014 but fungi was again seen in February 2014. No issues were seen in April 2014. There was fungi growth in May and June 2014.

During interview on 7/17/14 at approximately 5:15 PM, the Pharmacy Manager stated that s/he informed team members in infection control, environment of care and building services of the mold issue in the pharmacy and notified others via email of the issues, however, was unable to provide documentation that supported this. The Manager further stated that an action plan was developed that went to the environment of care committee in June 2014 to include HVAC revision, however, no date of work was identified as IV compounding continued at the infusion center until 7/8/14, when the compounding room at the infusion center was closed.


The first action plan provided by the Pharmacy Manager is dated 4/10/14 for the mold growth seen in February 2014. The Manager was unable to speak to issues prior to employment date of February 1, 2014. It is a "rolling" plan where items are added but failed to address each specific finding in the EM testing. The action plan for 4/10/14 states "passed USP-797 standards but needs corrective action" despite mold growth on surfaces in the ante and chemo buffer areas. There were no action plans seen before 4/10/14.


d. Review of the hospital pharmacy EM testing reports, performed by Company #1 and/or #2, identified mold growth in various areas in air and surface samples in February 2013, June 2013, and July 2013, with the February 2013 surface sample at the edge of the BSC.

During interview on 7/17/14 at 10:40 AM, the Pharmacy Manager stated s/he began employment on February 1, 2014 and prior to employment, was unable to provide documentation that these concerns were addressed.

The February 2014 samples show an actionable level of CFU's (195) in the ante room sink surface sample. There is no action plan to show any remediation was done to address these findings or re-testing done. As of 7/18/14, no EM tests were done in the room since to ensure that sanitary conditions exist.


e. Review of the testing and certification report dated February 12, 2014, completed by Company #2, (known for contamination control), for the IV Infusion Center identified the following report discrepancies:

i-The positive pressure from the IV buffer area to the ante area was too low.

ii-The positive pressure from the ante area to the outside was too low.

iii- The chemo buffer area failed to qualify for ISO7.

iv- The humidity seen in all three rooms ranged from 12.5% to 13.1%.

v-The Room Air Exchange Rate in the ante room incorrectly listed acceptance criteria even though the actual number meets USP-797 standards.

vi-The particle counts for the chemo buffer area noted in two sections of the report (particle counts and in statistical analysis) do not match.


The facility was unable to provide documentation of follow-up or action plans that the above discrepancies were addressed, remediated and/or that re-testing had occurred.


Review of the testing and certification report dated April 2, 2014, completed by Company #2, identified the following discrepancies:


i-The company completed pressure reading between the rooms only. The positive pressure from the ante area to the outside was too low.


Review of the testing and certification report dated May 30, 2014, completed by Company #2, identified the following discrepancies:


i-There is no documentation that this certification was completed under dynamic conditions.

ii-The acceptance criteria for the Room Air Exchange Rate in the ante room was incorrectly listed (the actual number meets the standards).

iii-The ante area is classified as ISO8 even though it should be classified as ISO7 due to
chemo buffer area coming off the ante area.


The facility was unable to provide documentation of follow-up or action plans that the above discrepancies were addressed, remediated and/or that re-testing had occurred.



f. Review of the environmental testing, by Contamination Service Company #1 during the period of January 2013 through January 2014, identified the following concerns:

i- No temperature or dates of incubation.

ii- There was testing start and completion dates that failed to state on what dates the samples were taken.

iii- No documentation if the air samples were volumetric impaction collections.

iv- No sampling (air or surface) done in the PEC until December 2013.

v- With the exception of September 2013, no documentation of lot number and expiration dates of the media used. Additionally documentation failed to reflect whether the growth media had neutralizing agents for the surface samples.

iv- The sample plan was incorrect, showing a BSC in the IV buffer room instead of an LAFW.

There is no action plan seen on what was done to correct these issues.


Review of the environmental testing, completed by Company #2 for the February 2014 and April 2014 reports, identified the following concerns:

i- No temperature or dates of incubation.

ii- February and April 2014 reports had errors showing the ante room as an ISO8 area which changes the colony forming units (CFU) actionable levels.

iii- Additionally, the sampling plan reflects tables where none exist in the ante room (surface sample marked S9). In February 2014, no sink was marked in the ante room but was identified as a table in the sampling plan.

The facility was unable to provide documentation that there errors were addressed.



g. Review of the hospital pharmacy certification reports completed on 7/10/13 and 2/12/14 identified the following concerns:

i- The 7/10/13 report, showed the positive pressure in the ante room to the outside to be 0.01 inches of water column, which is too low (needs to be between 0.02 -0.05 inch of water column) and the room failed under pressurization.

ii- The humidity seen in the buffer area was from 89.8% to 93.5% for the four readings taken and 86.5% to 86.9% for the 3 readings done in the ante area (facility standard between 30 and 60%).

iii- The 2/12/14 report, showed the humidity as 8.3% to 8.9% in the ante room and 8.1% to 8.3% in the buffer area. There was no explanation for these numbers and how they compare to the last report.

There was no action plan to identify what was done to correct these issues.


Review of the aforementioned reports and interview with the Pharmacy Manager on 7/17/14 at 10:40 AM stated s/he began employment on February 1, 2014, therefore the 7/10/13 report would have been addressed to the previous Pharmacy Director. The Manager indicated that his/her concern with the contractor included communication issues and untimely reports. The Director failed to recognize issues within the reports that required immediate follow-up to ensure a safe environment was maintained.


h. The minutes failed to indicate a concern of mold/fungi growth at the IV Infusion Center and/or hospital pharmacy although members were aware of the issues.

Review of the Pharmacy and Therapeutics Committee minutes for the period of 1/31/13 through 5/18/14, identified that the Director of Pharmacy changed in February 2014; other committee members included in part, VP of Patient Care, AVP #1, ICN #1 and Pharmacy Director (Secretary). The minutes failed to reflect that mold was first identified in January 2013 and continued through June 2014 within the compounding rooms at the outpatient infusion center (with the exception of a few months with negative cultures). From August 2013 into September 2013, the outpatient infusion center was closed to patients and pharmacy compounding secondary to remediation of mold growth at that time. The minutes failed to reflect this.


Review of committee memberships identified that the Pharmacy Manager participated in the environment of care, pharmacy and therapeutics and infection control meetings. None of these meeting minutes reflected concern for mold growth at the pharmacy compounding areas despite knowledge of this concern.


During interview 7/17/14 at 10:40 AM, the Pharmacy Manager on stated the plan included reeducation of staff regarding infection control techniques. Review of the education provided dated 7/17/14 and 7/21/14, indicated that only three (3) of eleven (11) staff received the education.


Review of the job description for the Manager of Pharmacy reflected responsibility for the management and coordination of resources on a daily basis including anticipation and identification of potential problems in either direct pharmaceutical care and/or assigned area of operations with facilitation of an effective resolution of problems.

Based on observation, review of facility documentation, interviews, and policy review, the hospital, who compounds sterile pharmaceuticals, failed to comply with Federal and/or state laws, United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations and/or maintain a sanitary environment to ensure patient safety. The findings include:


1. During tour of the IV infusion center on 7/16/14 at 11:30 AM with the Pharmacy Director, the Pharmacy Manager, the Program Director, Nurse Manager, and Assistant Vice President of Ancillary Services (AVP #1), the following concerns were identified:

a. In the storage room, the floor beneath two (2) large racks that contained supplies for provision of services was observed to be dusty. Boxes that stored intravenous (IV) fluids had accumulated dust. Although the program Director stated a monthly cleaning schedule was in place, staff failed to ensure this room was clean.

b. Review of the temperature and humidity log dated July 2014 for the locked storage closet that stored medication identified that humidity levels were not recorded on seven (7) of ten days and that temperatures were not recorded on two (2) of the ten days secondary to "no thermometer".



2. During tour of the hospital pharmacy compounding rooms on 7/18/14 at approximately 11:30 AM with the Pharmacy Manager identified the following concerns:

a. No pressure gauges to monitor pressure of ante, chemo and IV buffer areas. (subsequent to inquiry, they were installed on July 24, 2014).

b. The ceiling tiles were not caulked around each perimeter to seal them to the support frame.

c. Jewelry and makeup was observed to be worn by Pharmacy Technician #1 who had just finished compounding and was exiting the compounding areas. Review of the Preparation of Compounded Sterile Products Assessment for USP-797 identified that the technician passed the test on 5/21/14, which included that jewelry/make-up can not be worn in the compounding area.

d. Garbing (with PPE) was not done in the sequence as outlined in the facility policy. All the PPE's were kept outside the ante area.

e. No line of demarcation was observed in the ante area that delineated "clean" from "dirty".

f. Multiple mop heads were kept in a plastic bag on top of the water pump. The water pump was covered in dust and there failed to be documentation of who and when it was last cleaned.

g. Bins used to hold drug products were dirty.

h. A ladder was observed in the ante area, where it was placed to fix the ceiling tile in the buffer area.

i. A corner of the wall above the sink appeared to have black material on two adjacent walls near the ceiling.

j. A large crack in the vinyl seam on the floor was observed.

k. Both the BSC and LAFW were in positive pressure rooms where the BSC was being used to compound chemo products. The BSC was vented to the outside but there were no closed system vial transfer devices (CSTD) being used to compound chemo products.

l. The tile above the BSC (hood for sterile preparation of medications) was not properly aligned in its supporting structure with wires hanging through the space created. The tile was discolored on the inside, indicative of a water leak. Staff were unable to identify how long the tile had been askew. Plenum air was being introduced in the room without going through a HEPA filter.

Subsequent to inquiry, the wall and ceiling tile were swabbed by a facility microbiologist and submitted for culture. Review of the description of work completed monthly by cleaning contractor #1 identified that the ceilings and walls were mopped and sanitized on June 26, 2014.

m. Two chairs were observed to have considerable amount of rust on the base rendering an inability to effectively sanitize the equipment.

n. The LAFW HEPA filter had staining with no EM testing of the stain.


Hospital staff failed to recognize and correct the aforementioned concerns during day-to-day operations.


3. During tour of the hospital pharmacy on 7/21/14 at approximately 2:20 PM with the Pharmacy Manager identified the following concerns:


a. Patient's personal medications stored in manilla envelopes were observed in a drawer intermingled with coffee supplies. Review of Patient #25's medication envelope identified the patient was admitted on 1/23/07. Interview with the Pharmacy Manager on 7/21/14 identified that medication brought from home are stored in the pharmacy and returned to the patient upon discharge and/or thirty (30) days following discharge if the medications are not requested back.

b. The narcotic refrigerator was not being monitored for temperature. Subsequent to inquiry, monitoring commenced.

c. Clean gloves located outside of the infusion room were stored on top of the biohazard box.

d. Approximately fifteen (15) bags of IV bags were observed to be hanging on hooks defrosting with a metal pan directly beneath to catch the water. The pan had collected dirt/debris from the overhead ceiling tile that was askew. Subsequent to inquiry, the IV bags were removed from circulation.



4. The following observations were made on 7/28/14 at approximately 3:00 PM and identified the following concerns:

a. Gowns used for compounding were too low on the neck exposing skin of the Technician.

b. Pharmacy Technician #2 had a visible piercing. It was confirmed by RPH #2 that s/he had compounded that morning.



During interview on 7/18/14 at approximately 2:00 PM, the Infection Control Nurse stated that s/he does not perform surveillance activities of the Pharmacy compounding rooms during environmental rounds (approximately every six months) as s/he expects the Department Managers to monitor day to day functions such as handwashing and the environment.



Review of the Pharmacy policy for sanitizing procedures and staff competency for sterile compounding identify the importance of each step that is required during the sanitizing of the room and appropriate garbing. The policies stipulate that the Director of Pharmacy/Pharmacy designee will ensure adherence to these policy/procedures.


Review of the compounding personnel hand hygiene and garbing competency directed jewelry and make-up should be removed prior to entry into the ante room and staff are aware of the line of demarcation separating clean and dirty sides.

Based on observation, review of hospital documentation, policies, and interviews, it was determined that the hospital failed to meet the Condition of Participation for Environment as evidenced by:


1. The hospital failed to ensure that the physical environment and mechanical HVAC systems were being maintained efficiently and in compliance with federal and state laws. (Cross reference A-492 & A-501) (Refer to A-701 and A-726)

a. Review of reports completed by Company #1 (contracted service who provides environmental testing) during the period of January 2013 through August 2013 for the IV Infusion Center compounding rooms, identified mold growth in various areas in air and surface samples. There was mold growth in October, November, and December 2013. No issues were seen in January 2014 but fungi was again seen in February 2014. No issues were seen in April 2014. There was fungi growth in May and June 2014.

The first action plan provided by the Pharmacy Manager is dated 4/10/14 for the mold growth seen in February 2014. The Manager was unable to speak to issues prior to employment date of February 1, 2014. It is a "rolling" plan where items are added but failed to address each specific finding in the contractor reports (refer to A-83 for specific issues). The action plan for 4/10/14 states "passed USP-797 standards but needs corrective action" despite mold growth on surfaces in the ante and chemo buffer areas. There are no action plans seen before 4/10/14 to ensure that the environmental concerns were addressed.

During interview on 7/17/14 at approximately 5:15 PM, the Pharmacy Manager stated that s/he informed team members in infection control, environment of care and building services of the mold issue in the pharmacy and notified others via email, however, was unable to provide documentation that supported this. The Manager further stated that an action plan was developed that went to the environment of care committee in June 2014 to include HVAC revision however, no date of work was identified as IV compounding continued at the infusion center until 7/8/14, when the compounding room at the infusion center was closed.

Review of the Environment of Care meeting minutes dated 4/16/2014 and attended by Assistant Vice President (AVP) #1, Director of Engineering, Pharmacy Manager and Infection Control Nurse #1, identified that there were concerns of not meeting the requirements of USP-797 for intravenous compounding secondary to the increasing temperatures greater than 68 degrees Fahrenheit and increasing humidity greater than 70%. An undersized HVAC system had been identified in August 2013, as the cause for the increasing humidity levels.

During interview on 7/22/14 at 12:50 PM, the Director of Engineering stated that the former CEO/VP of Patient Care had been aware of the mold issues. Although the issue of mold had been discussed at several EOC (environment of care) meetings, less expensive changes (i.e.., covering the windows in one room) were made with a plan to address the HVAC system in the future.

b. Review of reports completed by Company #1 & Company #2 (contracted service who provides environmental testing) for the Hospital Pharmacy compounding rooms, identified mold growth in various areas in air and surface samples in February 2013, June 2013, and July 2013, with the February 2013 surface sample at the edge of the BSC.

Review of hospital documentation and interviews during the course of the inspection failed to identify that an action plan was developed pursuant to the environmental testing reports in February 2013, June 2013, and July 2013, There were no action plans to demonstrate that remediation was completed to address these findings and ensure that the environment of care was maintained to ensure the safety of the patients.

Based on observation, review of hospital documentation, interviews, and policies and procedures, the hospital failed to ensure that the physical environment of the I.V. Infusion Center (Enfield Campus) and the main hospital was in compliance with federal and state laws (USP-797) as required. The findings include the following:

Cross reference A-492 and A-501


a. Observations of dirt and debris were identified in the Ante, Chemo and I.V. Rooms on the floor near the cove base in the Hospital on 7/21/14 and I.V. Infusion Center on 7/16/14.

b. Ceiling tiles were found in the Ante, Chemo and I.V. rooms that were not sealed/caulked in place to prevent contamination and/or air pressure loss in the Hospital on 7/21/14 and I.V. Infusion Center on 7/16/14.

c. There were areas on the walls in the Ante, Chemo and I.V. Rooms where paint was chipping in the I.V. Infusion Center identified on 7/16/14.

d. There was ceiling discoloration and damage identified in the bathroom and storage room in the I.V. Infusion Center identified on 7/16/14.

e. There was a separation of the welded seam identified in the floor of the Hospital Pharmacy identified on 7/21/14.


Review of work orders with the Director of Engineering on 7/17/14, it was identified that an adequate and effective preventive maintenance program could not be produced to utilize and track daily preventive maintenance work orders and other daily maintenance performed. The work orders that were supplied had incorrect detailed information such as incorrect staff names performing work, incorrect times of completion, and inadequate work requested/performed and actions taken for correction.

Based on observation, review of hospital documentation, policies and procedures and interviews the hospital failed to ensure that the air handling equipment in the I.V. Infusion Center (Enfield Campus) and the main hospital was in compliance with federal and state laws (USP-797) as required. The findings include the following:

Cross reference A-492 and A-501


a. During a tour of the facility on 7/16/14 with Director of Engineering, it was observed that the Ante room, IV room and Chemo Buffer room were not supplied with an air handling system which was separated from the main air handling system that supplies the entire facility at the I.V. Infusion Center.

b. There were no pressure gauges to monitor the pressure of the Ante, Chemo and I.V. Buffer rooms in the Hospital and I.V. Infusion Center.

c. There was a damper attached to the ventilation system on the Biological Safety Cabinet which is non-compliant to the proper ventilation of this area in the I.V. Infusion Center identified on 7/16/14.

d. The air return registers in these areas were identified as returning room air back into the ceiling plenum and being recirculated back to the room, there was no indication that fresh air was being brought into the room through a compliant HVAC system and supplied to HEPA filters and returning to the air handler as required in the I.V. Infusion Center identified on 7/16/14.

e. Review of facility documentation and interview with the Director of Engineering on 7/16/14 failed to identify which HEPA filters were changed specifically and the frequency of the changes at the Hospital and I.V. Infusion Center.

Based on observation, review of hospital documentation, policies, and interviews, it was determined that the hospital failed to meet the Condition of Participation for Infection Control as evidenced by:


1. The hospital failed to ensure that the Infection Conrol program was comprehensive to include high risk areas including surveillance of the hospital's pharmacy and/or IV infusion center. (Refer to A-749)

Based on a review of hospital documentation, review of hospital policies and interviews, the hospital failed to ensure the Infection Control program effectively evaluated and monitored the presence of mold/fungus identified during environmental testing at the IV Infusion center and the hospital pharmacy dating back to 1/13 to establish a plan of surveillance to maintain a mold-free environment. The findings include the following:

Cross reference A-501.

a. Review of reports completed by Company #1 & Company #2 (contracted service who provides environmental testing) during the period of January 2013 through May 2014 identified the presence of mold/fungus at the IV Infusion Center and the hospital pharmacy compounding room.


Review of the Infection Control Minutes for the period of 10/14/13 through 5/2014, failed to identify that this was a concern. Although committee membership included physicians, nurses, pharmacists, facility environmental maintenance and microbiology, the hospital representatives failed to share information to establish a plan of surveillance/monitoring to maintain a mold-free environment.


During interview on 7/18/2014 at approximately 2:20 PM, the Infection Control Nurse (ICN #1) stated that s/he did know of the mold problem at the outpatient infusion center however, did not complete surveillance rounds of the pharmacy compounding room at the IV Infusion center or the hospital pharmacy. ICN #1 further stated that MD #2 was aware of the mold problem and suggested that it could be coming from the air handling system however, ICN #1 failed to document any suggestions and/or bring the matter before the Infection Control Committee.


During interview on 7/17/14, MD #1 (Medical Director of Infusion Center) stated that s/he was first aware of a mold problem approximately one year ago (August 2013) when the infusion center closed for one month for remediation of the problem. MD #1 stated that the Program Director of the Infusion center notified him/her of the mold growth problem in May 2014, however, was unaware of the plan to remediate of the problem.


During interview on 7/28/14 at 1:00 PM, MD #2 (infectious disease) stated that s/he was aware that there had been a mold problem in the pharmacy since approximately August of 2013. MD #2 stated that the facility (outpatient infusion center) had closed in response. Although the physician was aware of the mold problem, there was a failure to participate in the solution and/or to complete a risk analysis to determine the level of risk to the patients being served.


During interview on 7/23/14 at 9:15 AM, AVP #1 stated that s/he was unaware of the mold growth problem until 7/8/14, when the issue was brought to the attention of the CEO and the infusion center was closed for remediation. Review of the Environment of Care (EOC) meeting dated March 19, 2014 identified that the clean room did not pass inspection and AVP #1 questioned if the room was "ok" to use. The EOC meeting minutes dated 4/16/14, reflected that AVP #1 was present when the Pharmacy Manager identified mold/fungus was present in the IV infusion center secondary to high temperatures/humidity/room pressures which did not meet the standards of USP-797 for compounding intravenous solutions.


Review of the job description of the Infection Control Nurse (ICN) identified that the ICN was accountable to the VP of Patient Care Services and the hospital epidemiologist for effectively managing resources, assessing and evaluating infection control practices and the program itself within the hospital.


Review of the infection control policy for monitoring and compliance directed that infection control and environmental rounds shall be conducted annually in all departments and biannually in patient care/clinical areas in conjunction with the environment of care team (engineering, building services & quality) to monitor adherence to hospital-wide and department specific infection prevention policies.







16649