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Based on observation, review of facility documentation, contracted service reports, interviews, and policy review, 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-724, A-747, and A-749.


2. The Governing body failed to function effectively to ensure quality services were provided by two contractors, Company #1 and Company #2.

Please refer to A-83


Based on observations, review of facility documentation, contractor reports, and interviews, the following was ascertained:


a. During tour of the pharmacy on 2/9/16 at 10:00 AM with the Interim Director of Pharmacy, the CNO, and Pharmacist #1 it was identified that the compounding area was under construction and the non-chemo isolator was moved into the staff break room on 1/6/16 per interview. The non-chemo isolator was in a staff break room that as observed to be cluttered with kitchen and office supplies including the counter tops where intravenous bags were placed after compounding was completed. Dust was also visible throughout the room. A line of demarcation that differentiated dirty from clean was absent. Interview with the Interim Director of Pharmacy (contractor #2) on 2/9/16 at 10:10 AM stated medications compounded in this isolator included but was not limited to Insulin drip, Thiamine, Epinephrine, Diltiazem, Vancomycin, Zosyn, Multivitamins, Iron Oxide and Ranitidine.


b. Continued tour of the room where the isolator was located with the Interim Director of Pharmacy on 2/9/16 failed to identify that the room had a thermostat to ensure the temperature of the room was maintained within an acceptable range to compound medications. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:30 AM stated although he was aware that the room needed to be monitored he had only been in the facility for one month and did not have the opportunity to review all systems in place.


c. The Interim Director of Pharmacy failed to identify that pressures within the isolator were monitored to ensure the required ISO classification was maintained in accordance with manufacturer guidelines and/or USP 797. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:35 AM stated although he was aware the isolator needed to be monitored, he had only been in the facility for one month and did not have the opportunity to review all systems in place.


d. The Interim Director of Pharmacy failed to identify that humidity levels were monitored in the room where medications were compounded/stored in accordance with USP 797. Interview with the Interim Director of Pharmacy on 2/9/16 at 10: 40 AM stated although he was aware that humidity levels needed to be monitored, he had only been in the facility for one month and did not have the opportunity to review all systems in place.


e. On 7/1/14, USP 797 requirements were enforceable for Connecticut hospitals. Subsequent to that date, a copy of the certification reports for the IV compounding room was requested. Review of the contract reports (Company #1) during the period of July of 2014 through February of 2015 failed to identify that the reports were comprehensive to include; an airflow smoke pattern test was conducted and/or a preparation ingress and egress test was completed and/or particle testing was conducted under dynamic conditions in the antechamber in accordance with USP 797. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:45 AM stated he had only been in this role for one (1) month therefore had not reviewed any of these reports. Review of the aforementioned reports and interview with the Chief Nursing Officer (CNO identified that the prior pharmacy director handled the testing and/or reports as part of the directors responsibility.


f. Governing Body Committee Minutes dated July of 2014 through February of 2015 failed to identify concerns with contracted services, specifically, Company #1 and Company #2. Interview with the CNO on 3/2/16 stated she attended the Governing Body Committee meetings and the prior pharmacy director did not report concerns regarding certification/environmental testing.


g. Although the hospital had policies related to sterile compounding dated January 2014, entitled Sterile Preparation:Cleaning and Disinfecting the Sterile Compounding Area, Quality Control and Quality Assurance, Environmental Monitoring and Competency for the Pharmacy Staff, the hospital failed to ensure the policies were followed.


Interview with the CEO on 3/3/16 identified he did not have knowledge of the USP 797 law that was enforceable in July of 2014. The CEO indicated the pharmacy was a contracted service and he expected to be informed of USP 797 regulations through the employees of the contract so that he could ensure compliance. Additionally the CEO indicated that although he was aware that environmental cultures were conducted through the quality council and governing body meetings, he did not have an understanding of its meaning. Further interview with the CEO identified he was responsible to oversee the pharmaceutical contract to ensure the services provided were in compliance with state laws.


On 2/11/16 the facility submitted an immediate action plan to the Department of Public Health that identified the following components in part, one (1) hour beyond use date, a thorough cleaning of the room where the isolator was located and to initiate a line of demarcation. A certification company was consulted to perform viable air sampling immediately and media fill testing and fingertip sampling would also be conducted. A thermometer and humidity monitor were installed and a daily log was initiated to record temperature, humidity and isolator pressures. Daily cleaning of the segregated compounding room would also be conducted. Pharmacy personnel would be trained and complete all competencies.

Based on observation, review of facility documentation, contracted service reports, interviews, and policy review, the Governing body failed to ensure that quality services were rendered by Company #1 who conducted certification of the isolator/s and/or by Company #2 who provided pharmaceutical services for the hospital. The findings include the following:


On 2/9/16 during a tour of the pharmacy it was identified that the compounding area was under construction and the non-chemo isolator was moved into the staff break room on 1/6/16. Pharmacist #1 indicated that the chemotherapy isolator had not been operational since 4/14/14 as chemotherapy services were provided at a community infusion center.


a. Review of reports completed by Company #1 (contracted service who provides certification for the facilities isolator) dated 1/4/16 failed to identify that an airflow smoke pattern test was conducted and/or a preparation ingress and egress test was completed and/or particle testing was conducted under dynamic condition in the antechamber in accordance with USP 797.


b. Further review of the reports indicated that certification testing of the non-chemo isolator failed to be completed in July of 2015 and had not been conducted since February of 2015.


The hospital policy entitled Sterile Preparation: Sterile Compounding Area directed in part that the sterile compounding facility shall be checked for operational efficiency by a qualified certifier at least once every six months.


c. Review of the environmental reports completed by the hospital during the period of July 2014 through February 2016 failed to identify that comprehensive surface sampling was conducted within the chemo and non-chemo isolators. The chemo isolator identified one (1) area that was sampled and in the non-chemo isolator, three (3) areas were sampled. Sampling was absent in the ante chambers of both isolators. The facility was unable to provide a risk assessment to determine what the hospitals comprehensive sampling should entail.


The hospital policy entitled Sterile Preparations: Environmental Monitoring Viable dated January 2014 directed in part that an environmental sampling plan would be in place to detect airborne viable particles based on a risk assessment of activities performed. Locations would include those prone to contamination during compounding activities such as staging, labeling, gowning and cleaning.


d. Review of the surface environmental reports from July 2014 through February 2016 indicated that the chemo isolator identified growth on 7/31/14. In the non-chemo isolator growth was identified on site #3 on 9/29/15 and 11/13/15 absent speciation and/or colony forming units (CFU) to ascertain if a microorganism has exceeded a threshold in accordance with USP 797. Although terminal cleaning was listed as the action plan, interviews with Pharmacist #1 and Pharmacy Technician #1 indicated that only daily cleaning of the isolator was completed and the staff was never trained to conduct terminal cleaning.


The hospital policy entitled Sterile Preparations: Competency for Pharmacy personnel dated January 2014 directed in part that surface sampling test that revealed colony forming units above the established threshold would be evaluated by Infection Control.


The hospital policy entitled Sterile Preparations: Environmental Monitoring Viable dated January 2014 directed in part that any CFU count that exceeds its respective action level should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures and air filtration efficiency within the aseptic compounding location. Any CFU should be identified to at least a genus level.


e. Further review of the environmental testing dated July of 2014 through February 2016 failed to identify that air sampling was conducted within the isolators in accordance with USP 797. Interview with the Interim Director of Pharmacy (contractor #2) on 2/9/16 at 10:45 AM stated he had only been in this role for one (1) month therefore had not reviewed any of these reports.


Interview with the CEO on 3/3/16 identified he was responsible to oversee the contract for Company #1 that conducted mechanical testing of the isolators and for Company #2 who provided the hospital with pharmaceutical services. The CEO indicated he did not review the certification reports, environmental testing or collaborate with Company #2 to ensure the services rendered were comprehensive or complete.

Based on a review of hospital documentation, contractor reports, interviews, and policies, 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 develop specific QAPI indicators to monitor the performance of contracted services (Company #1 and #2) and/or ensure the Infection control program effectively monitored high risk area's including but not limited to Pharmacy services.


Refer to A-283


Cross reference A-83, A-490, A-492, and A-747.

Based on observation, review of facility documentation, contracted service reports, interviews, and policy review, the hospital failed to develop quality performance improvement activities regarding high risk area's in the hospital that included contracted services (Pharmacy). The findings include the following:

Cross reference A-83

During tour of the pharmacy on 2/9/16 at 10:00 AM with the Interim Director of Pharmacy, the CNO, and Pharmacist #1 it was identified that the compounding area was under construction and the non-chemo isolator was moved into the staff break room on 1/6/16 per interview. The non-chemo isolator was in a staff break room that as observed to be cluttered with kitchen and office supplies including the counter tops where intravenous bags were placed after compounding was completed. Dust was also visible throughout the room. A line of demarcation that differentiated dirty from clean was absent.
Review of reports completed by Company #1 (contracted service who provides certification for the facilities isolator) dated 1/4/16 failed to identify that an airflow smoke pattern test was conducted and/or a preparation ingress and egress test was completed and/or particle testing was conducted under dynamic condition in the antechamber in accordance with USP 797.


Further review of the reports indicated that certification testing of the non-chemo isolator failed to be completed in July of 2015 and had not been conducted since February of 2015.


The hospital policy entitled Sterile Preparation: Sterile Compounding Area directed in part that the sterile compounding facility shall be checked for operational efficiency by a qualified certifier at least once every six months.


Review of the environmental reports completed by the hospital during the period of July 2014 through February 2016 failed to identify that comprehensive surface sampling was conducted within the chemo and non-chemo isolators. The chemo isolator identified one (1) area that was sampled and in the non-chemo isolator, three (3) areas were sampled. Sampling was absent in the ante chambers of both isolators. The facility was unable to provide a risk assessment to determine what the hospitals comprehensive sampling should entail.


The hospital policy entitled Sterile Preparations: Environmental Monitoring Viable dated January 2014 directed in part that an environmental sampling plan would be in place to detect airborne viable particles based on a risk assessment of activities performed. Locations would include those prone to contamination during compounding activities such as staging, labeling, gowning and cleaning.


Review of the surface environmental reports from July 2014 through February 2016 indicated that the chemo isolator identified growth on 7/31/14. In the non-chemo isolator growth was identified on site #3 on 9/29/15 and 11/13/15 absent speciation and/or colony forming units (CFU) to ascertain if a microorganism has exceeded a threshold in accordance with USP 797. Although terminal cleaning was listed as the action plan, interviews with Pharmacist #1 and Pharmacy Technician #1 indicated that only daily cleaning of the isolator was completed and the staff was never trained to conduct terminal cleaning.


The hospital policy entitled Sterile Preparations: Competency for Pharmacy personnel dated January 2014 directed in part that surface sampling test that revealed colony forming units above the established threshold would be evaluated by Infection Control.


The hospital policy entitled Sterile Preparations: Environmental Monitoring Viable dated January 2014 directed in part that any CFU count that exceeds its respective action level should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures and air filtration efficiency within the aseptic compounding location. Any CFU should be identified to at least a genus level.


Further review of the environmental testing dated July of 2014 through February 2016 failed to identify that air sampling was conducted within the isolators in accordance with USP 797. Interview with the Interim Director of Pharmacy (contractor #2) on 2/9/16 at 10:45 AM stated he had only been in this role for one (1) month therefore had not reviewed any of these reports.


a. Review of the P&T minutes (chaired by the Director of Pharmacy) dated July of 2014 through February of 2016 and interview with the CNO on 3/3/16 at 1:00 PM noted "growth or no growth", however, failed to identify that comprehensive testing was conducted by Company #1.

b. Review of the Infection control minutes dated July 2014 through February 2016 and interview with the CNO on 3/3/16 at 1:30 PM failed to identify that a comprehensive mechanism was in place to identify and monitor potential infections in the compounding area of the pharmacy. Further review of the infection control meeting minutes failed to reflect that the facility analyzed the environmental testing that was conducted to determine implementation of appropriate interventions to prevent and control communicable disease. The minutes failed to reflect that surveillance rounds were conducted in the compounding area of the hospital and/or that other departments and specialty areas collaborated regarding adherence to the USP 797 guidelines and compliance with Pharmacy policies. Interview with the Infection Control Nurse and the Infectious Disease physician on 3/3/15 indicated he/she had heard of patient safety issues with compounding however were not aware of USP 797 guidelines and all of the criteria and/or elements required to ensure compliance with the law.

Further interview with the CNO indicated the meeting minutes from P&T and Infection control are then brought for review to the Quality Assurance Committee.

c. Review of the Quality Assurance Committee Minutes dated July 2014 through February 2016 and interview with the CNO on 3/3/16 at 2:00 PM failed to identify that concerns regarding contracted services was discussed. The CNO indicated the meeting minutes from the Quality Assurance Committee and are then brought for review to the Medical Executive Committee.

d. Review of the Medical Executive Committee Minutes and interview with the CNO on 3/3/16 at 2:20 PM lacked documentation to support a review of concerns identified in the compounding area of the pharmacy that were discussed for disposition.

e. Review of the Governing Body Minutes and interview with the CEO on 3/3/16 at 3:00 PM identified that all of the aforementioned subcommittee minutes are complied into a binder prior to the governing body meeting that is held every other month for all members to review. The CEO indicated he did not have knowledge of the USP 797 law that was enforceable in July of 2014 therefore he did not inquire or recognize elements of USP 797 that were not conducted. The CEO identified the pharmacy was a contracted service and he expected to be informed of USP 797 regulations through the employees of the contract so that he could ensure compliance.

Based on observation, a review of hospital documentation, contractor reports, interviews, and policies, 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 that the Pharmacy Director (Contractor #2) effectively supervised the day to day operations of the Pharmacy Department as evidenced by failure to follow policy/procedures, failure to ensure environmental sampling and certification of the isolators were comprehensive, failure to compound medications in a sanitary environment and/or maintain compliance with federal and state laws (USP-797).


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 the isolators where intravenous compounding was performed was tested/certified and/or that environmental testing was conducted in accordance with Federal and/or state laws, United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding (USP-797). The findings include:


Cross reference A-501


a. During tour of the pharmacy on 2/9/16 at 10:00 AM with the Interim Director of Pharmacy, the CNO, and Pharmacist #1 it was identified that the compounding area was under construction and the non-chemo isolator was moved into the staff break room on 1/6/16 per interview. The non-chemo isolator was relocated in a staff break room that was observed to be cluttered with kitchen and office supplies including the counter tops where intravenous bags were placed after compounding was completed. Dust was also visible throughout the room. A line of demarcation that differentiated dirty from clean was absent. Interview with the Interim Director of Pharmacy (contractor #2) on 2/9/16 at 10:10 AM stated medications compounded in this isolator included but was not limited to Insulin drip, Thiamine, Epinephrine, Diltiazem, Vancomycin, Zosyn, Multivitamins, Iron Oxide and Ranitidine.


The hospital policy entitled Sterile Preparations dated January 2014: Segregated Compounding Area directed in part that the pharmacy would compound sterile preparations in a segregated compounding area which meets the requirements of USP 797.


The hospital policy entitled Sterile Preparations: Cleaning and Disinfecting the Sterile Compounding Areas dated January 2014 directed in part that sterile preparation areas and segregated compounding areas would be cleaned monthly to include the floors, walls, shelving and ceilings.


b. On 7/1/14, USP 797 requirements were enforceable for Connecticut hospitals. Subsequent to that date, a copy of the certification reports for the IV compounding room was requested. Review of reports completed by Company #1 (contracted service who provides certification for the facilities isolator) dated 1/4/16 failed to identify that an airflow smoke pattern test was conducted and/or a preparation ingress and egress test was completed and/or particle testing was conducted under dynamic condition in the antechamber in accordance with USP 797.



c. Further review of the reports indicated that certification testing of the non-chemo isolator failed to be completed in July of 2015 and had not been conducted since February of 2015.


The hospital policy entitled Sterile Preparation: Sterile Compounding Area directed in part that the sterile compounding facility shall be checked for operational efficiency by a qualified certifier at least once every six months.


d. Review of the environmental reports completed by the hospital during the period of July 2014 through February 2016 failed to identify that comprehensive surface sampling was conducted within the chemo and non-chemo isolators. The chemo isolator identified one (1) area that was sampled and in the non-chemo isolator, three (3) areas were sampled. Sampling was absent in the ante chambers of both isolators. The facility was unable to provide a risk assessment to determine what the hospitals comprehensive sampling should entail.


The hospital policy entitled Sterile Preparations: Environmental Monitoring Viable dated January 2014 directed in part that an environmental sampling plan would be in place to detect airborne viable particles based on a risk assessment of activities performed. Locations would include those prone to contamination during compounding activities such as staging, labeling, gowning and cleaning.


e. Review of the surface environmental reports from July 2014 through February 2016 indicated that the chemo isolator identified growth on 7/31/14. In the non-chemo isolator growth was identified on site #3 on 9/29/15 and 11/13/15 absent speciation and/or colony forming units (CFU) to ascertain if a microorganism has exceeded a threshold in accordance with USP 797. Although terminal cleaning was listed as the action plan, interviews with Pharmacist #1 and Pharmacy Technician #1 indicated that only daily cleaning of the isolator was completed and the staff was never trained to conduct terminal cleaning.


The hospital policy entitled Sterile Preparations: Competency for Pharmacy personnel dated January 2014 directed in part that surface sampling test that revealed colony forming units above the established threshold would be evaluated by Infection Control.


The hospital policy entitled Sterile Preparations: Environmental Monitoring Viable dated January 2014 directed in part that any CFU count that exceeds its respective action level should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures and air filtration efficiency within the aseptic compounding location. Any CFU should be identified to at least a genus level.


f. Further review of the environmental testing dated July of 2014 through February 2016 failed to identify that air sampling was conducted within the isolators in accordance with USP 797. Interview with the Interim Director of Pharmacy (contractor #2) on 2/9/16 at 10:45 AM stated he had only been in this role for one (1) month therefore had not reviewed any of these reports.


The hospital policy entitled Sterile Preparations: Quality Control and Quality Assurance dated January 2014 directed in part that semiannual certification of nonviable and viable environmental monitoring of all ISO 5 and segregated compounding areas would be conducted.


Interview with the Interim Director of Pharmacy on 2/9/16 at 10:45 AM stated he had only been in this role for one (1) month therefore had not reviewed any of these reports. The Interim Director of Pharmacy further identified he was aware of USP 797 guidelines however did not inquire about the hospital's compliance and was not aware of the mechanical or environment testing that was conducted or any other elements that were necessary to be compliant with USP 797.


Review with the aforementioned reports with the CNO on 3/3/16 at 11:15 AM identified that the prior pharmacy director handled the testing and/or reports as part of the directors responsibility.


g. Continued tour of the room where the isolator was located with the Interim Director of Pharmacy on 2/9/16 failed to identify that the room had a thermostat to ensure the temperature of the room was maintained within an acceptable range to compound medications. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:30 AM stated although he was aware that the room needed to be monitored he had only been in the facility for one month and did not have the opportunity to review all systems in place. The hospital policy entitled Sterile Preparations: Quality Control and Quality Assurance dated January 2014 directed that quality control practices in part would include daily documentation of temperature in areas where sterile products or sterile preparations are stored or compounded.



h. The Interim Director of Pharmacy failed to identify that pressures within the isolator were monitored to ensure the required ISO classification was maintained in accordance with manufacturer guidelines and/or USP 797. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:35 AM stated although he was aware the isolator needed to be monitored, he had only been in the facility for one month and did not have the opportunity to review all systems in place. The hospital policy entitled Sterile Preparations: Quality Control and Quality Assurance dated January 2014 directed that quality control practices in part would include daily documentation of pressure or velocity to monitor pressure differential or airflow between the buffer and ante-area and the general environment outside the compounding area.



i. The Interim Director of Pharmacy failed to identify that humidity levels were monitored in the room where medications were compounded/stored in accordance with USP 797. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:40 AM stated although he was aware that humidity levels needed to be monitored, he had only been in the facility for one month and did not have the opportunity to review all systems in place.


The hospital policy entitled Sterile Preparations: General directed in part that the Director of the Pharmacy shall ensure the sterility and integrity of sterile preparations compounded by the pharmacy department, and oversee the policies and procedures for compounded sterile preparations throughout the hospital.


The job description for the Director of Pharmacy, in part, included to plan, organize and direct all functions of the hospital pharmacy services. To ensure compliance with all state, local and federal regulations. Establish standards/training for sterile product preparation. To participate in the P&T committee assuring all pertinent information was communicated. To train and develop staff and ensure competency of designated staff on proper use of equipment and skills.

Based on observation, review of facility documentation, interviews, and policy review, the hospital, who compounds sterile pharmaceuticals, failed to maintain a sanitary environment and/or that staff competencies were conducted in accordance with hospital policies. The findings include:


1. During tour of the Pharmacy on 2/9/16 at 10:00 AM with the Interim Pharmacy Director and CNO, the following concerns were identified:


a. A non-chemo isolator was observed in a room cluttered with kitchen and office supplies including the counter tops where intravenous bags were placed after compounding was completed. Dust was also visible throughout the room. A line of demarcation that differentiated dirty from clean was absent.

Interview and review of the cleaning logs on 2/9/16 with Pharmacist #1 indicated although daily cleaning of the isolator was completed, terminal cleaning was not conducted in the break room since the isolator was re-located on 1/6/16 in accordance with USP 797. Further interview with Pharmacist #1 identified staff were not trained to conduct terminal cleaning.

Interview with the Interim Director of Pharmacy (contractor #2) on 2/9/16 at 10:10 AM stated medications compounded in this isolator included but was not limited to Insulin drip, Thiamine, Epinephrine, Diltiazem, Vancomycin, Zosyn, Multivitamins, Iron Oxide and Ranitidine.

The hospital policy entitled Sterile Preparations: Cleaning and Disinfecting the Sterile Compounding Areas dated January 2014 directed in part that sterile preparation areas and segregated compounding areas would be cleaned monthly to include the floors, walls, shelving and ceilings. The pharmacies policies failed to identify that a line of demarcation was necessary to differentiate dirty from clean.



b. On 2/9/16 at 1:00 PM, Pharmacy Technician #2 was observed with long fingernails, and was wearing nail polish and jewelry. The Technician washed her hands then proceeded to compound an IV medication. The Technician failed to clean beneath her nails and/or remove jewelry and/or remove nail polish prior to compounding in accordance with facility policy and/or USP 797 guidelines. The hospital policy entitled Sterile Preparation: General dated November 2014 directed in part that personnel working in the sterile compounding area shall keep their nails neat and trimmed, however, failed to include all components to ensure safe compounding.


c. Further observation of Pharmacy Technician #2 on 2/9/16 at 1:00 PM identified she placed the intravenous solutions and medications in the antechamber of the isolator and immediately opened the isolator and placed the compounding items into the main chamber. Interview with Pharmacy Technician #2 indicated she was not aware that a waiting time was necessary to return conditions to ISO 5 prior to the initiation of compounding. Subsequent to the observation the Interim Director of Pharmacy identified per manufacturers guidelines a five (5) minute waiting time was needed to return to an ISO 5 condition and placed a clock in the room to ensure compliance. The hospital policy entitled Sterile Preparations: Sterile Compounding Area dated January 2014 in part directed that the isolator shall maintain ISO class 5 conditions, including transferring ingredients, components, and devices into and out of the isolator and during preparation of medications that are compounded.


d. Interview with the Interim Pharmacy Director on 2/9/16 at 1:15 PM identified although written competencies were conducted yearly for the staff that compounded medications, observations where not conducted to ensure aseptic techniques and practices in accordance with USP 797 and should have been. The hospital policy entitled Sterile Preparations: Quality Control and Quality Assurance dated January 2014 directed in part that initial and annual competence documentation of personnel would include hand hygiene and garbing.


e. Interview and review of the finger-tip testing with Pharmacist #1 on 2/9/16 identified testing was not conducted in 2015 and should have been completed yearly. Subsequent to the surveyors inquiry finger-tip testing of the pharmacy staff was initiated. The hospital policy entitled Sterile Preparations: Quality Control and Quality Assurance dated January 2014 directed in part the initial and annual competence documentation of personnel would include glove fingertip sampling.

The facility failed to ensure that the condition of the physical plant and overall hospital environment was developed and maintained in a manner that provides an acceptable level of safety and well-being of patients, staff, and visitors based upon a tour of the Main Pharmacy on 02/10/16.


Please refer to A-701 and A-724

Based on tour of the Pharmacy, interviews and policy review, the Hospital failed to maintain the overall hospital environment in such a manner that the safety and well-being of patients are assured. The findings include the following:



On 02/10/16, the surveyor, accompanied by the Supervisor of Engineering and Property, observed the following:


a. The facility installed into service a temporary medication compounding room within the Main Pharmacy employee "breakroom" without first submitting a stamped set of architectural drawings for review and obtaining approvals from the Connecticut Department of Public Health detailing building construction equipment installed in the space.


b. The facility installed a fume hood designed to be utilized for the mixing of pharmaceutical medications in an employee "breakroom" that also contained a coffee maker, food products, personal belongings, a microwave oven, filing cabinets, and unsecured electrical power distribution panels.


c. The facility failed to provide pharmaceutical staff that mixes and handles medications with an area within the "breakroom" in proximity to the fume hood to safely process, handle, and store medications.


d. The facility constructed a new medication compounding room within the Main Pharmacy that contained a new medication compounding hood with associated HVAC ductwork, room pressurization monitoring equipment, and electrical equipment without first submitting a stamped set of architectural drawings detailing building construction, equipment installed in the space without obtaining an approval from the Connecticut Department of Public Health.


e. Continued tour of the room where the isolator was located with the Interim Director of Pharmacy (contractor #2) on 2/9/16 failed to identify that the room had a thermostat to ensure the temperature of the room was maintained within an acceptable range to compound medications. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:30 AM stated although he was aware that the room needed to be monitored he had only been in the facility for one month and did not have the opportunity to review all systems in place.


f. The Interim Director of Pharmacy failed to identify that pressures within the isolator were monitored to ensure the required ISO classification was maintained in accordance with manufacturer guidelines and/or USP 797. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:35 AM stated although he was aware the isolator needed to be monitored, he had only been in the facility for one month and did not have the opportunity to review all systems in place. The hospital policy entitled Sterile Preparations: Quality Control and Quality Assurance dated January 2014 directed that quality control practices in part would include daily documentation of pressure or velocity to monitor pressure differential or airflow between the buffer and ante-area and the general environment outside the compounding area.


g. The Interim Director of Pharmacy failed to identify that humidity levels were monitored in the room where medications were compounded/stored in accordance with USP 797. Interview with the Interim Director of Pharmacy on 2/9/16 at 10:40 AM stated although he was aware that humidity levels needed to be monitored, he had only been in the facility for one month and did not have the opportunity to review all systems in place.

The hospital failed to ensure that adequate provisions to ensure the availability and reliability of equipment needed for its operations and services was provided based upon observations conducted within the Main Pharmacy on 02/10/16. These observations include:


a. The facility constructed a new medication compounding room within the Main Pharmacy that contained a new medication compounding hood with associated HVAC ductwork, room pressurization monitoring equipment, and electrical equipment without first submitting a stamped set of architectural drawings detailing building construction, equipment installed in the space without obtaining an approval from the Connecticut Department of Public Health.

Based on observation, review of facility documentation, contracted service reports, interviews, and policy review, 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 Control program was comprehensive to include high risk areas including surveillance of the hospital's pharmacy.


Please refer to A-749

1. Based on observation, review of facility documentation, contracted service reports, interviews, and policy review, the hospital failed to ensure the Infection Control program evaluated and monitored the presence of "growth" identified during environmental testing at the hospital pharmacy to establish a plan of surveillance to maintain a safe environment. The findings include the following:

Cross reference A-492.

a. During tour of the pharmacy on 2/9/16 at 10:00 AM with the Interim Director of Pharmacy, the CNO, and Pharmacist #1 it was identified that the compounding area was under construction and the non-chemo isolator was moved into the staff break room on 1/6/16 per interview. The non-chemo isolator was relocated in a staff break room that was observed to be cluttered with kitchen and office supplies including the counter tops where intravenous bags were placed after compounding was completed. Dust was also visible throughout the room. A line of demarcation that differentiated dirty from clean was absent. Interview with the Interim Director of Pharmacy (contractor #2) on 2/9/16 at 10:10 AM stated medications compounded in this isolator included but was not limited to Insulin drip, Thiamine, Epinephrine, Diltiazem, Vancomycin, Zosyn, Multivitamins, Iron Oxide and Ranitidine.

Interview with the Infection Control Nurse on 3/3/16 at 11:15 AM indicated she assumed the role of Infection Control Nurse in July of 2015. The Infection Control Nurse stated she was not included in the decision to move the isolator prior to the initiation of construction and does not conduct surveillance rounds of the pharmacy.

b. On 7/1/14, USP 797 requirements were enforceable for Connecticut hospitals. Subsequent to that date, a copy of the certification reports for the IV compounding room was requested. Review of the environmental reports completed by the hospital during the period of July 2014 through February 2016 failed to identify that comprehensive surface sampling was conducted within the chemo and non-chemo isolators. The chemo isolator identified one (1) area that was sampled and in the non-chemo isolator, three (3) areas were sampled. Sampling was absent in the ante chambers of both isolators. The facility was unable to provide a risk assessment to determine what the hospitals comprehensive sampling should entail.

Review of the surface environmental reports from July 2014 through February 2016 indicated that the chemo isolator identified growth on 7/31/14. In the non-chemo isolator growth was identified on site #3 on 9/29/15 and 11/13/15 absent speciation and/or colony forming units (CFU) to ascertain if a microorganism has exceeded a threshold in accordance with USP 797. Although terminal cleaning was listed as the action plan, interviews with Pharmacist #1 and Pharmacy Technician #1 indicated that only daily cleaning of the isolator was completed and the staff was never trained to conduct terminal cleaning.

Further review of the environmental testing dated July of 2014 through February 2016 failed to identify that air sampling was conducted within the isolators in accordance with USP 797.

Review of the Infection Control Meeting minutes dated 8/27/15 and interview with the Infection control nurse on 3/3/16 at 11:15 AM stated environmental cultures identified "no growth". The meeting minutes dated 10/29/15 indicated the environmental cultures identified "growth" and cleaning was conducted. Further review of the minutes and interview with the infection control nurse and the CNO identified they were in attendance of the infection control meetings however were not involved in the results or analysis of the information as they felt it was the responsibility of the pharmacist.

Interview with the Infectious Disease Physician on 3/3/16 indicated he was aware of patient safety issues with intravenous compounding however was unaware of USP 797 guidelines and all of the criteria and/or elements required to ensure compliance with the law. Further interview with the Infectious Disease Physician indicated it would be important to obtain comprehensive environment sampling within the isolator to identify specific microorganisms and that he should be consulted for analysis and interpretation of the testing to determine appropriate interventions for remediation.

2. Based on a tour of the facility, review of facility policies, observations and interviews the facility failed to ensure that facility infection control practices were followed. The findings include the following:

a. During a tour of the OR with the OR Director on 2/9/16 at 10:56 AM, a surgical case was being performed in OR #3. Further observation at this time identified that the male scrub nurse had donned a mask and facial hair was exposed under the chin and at the sides of the face. Interview with the OR Director on 2/9/16 at 10:56 AM noted that the facility followed the Association of periOperative Registered Nurses (AORN) regarding OR attire. The facility policy for surgical attire identified that complete hair coverage is necessary in restricted areas (OR).

b. Patient #27 was admitted to the ED on 3/4/16 with a diagnosis of overdose. Observation on 3/3/16 at 2:10 PM identified the RN obtained blood from a finger on the patient's left hand, placed the strip with the patient's blood in the glucometer, and sanitized the glucometer with a 70% alcohol pad after use. The facility policy for maintenance of the glucometer (Precision Exceed Pro Glucometer) identified to clean the meter with alcohol or ammonia solution for decontamination. According to the Association for Professionals in Infection Control and Epidemiology (APIC) 2014 Infection Prevention; alcohol is never an acceptable disinfectant in shared- use situations.

c. During a tour of the emergency department (ED) on 3/2/16 at 1:55 PM, RN #4 was observed to draw up medication into a syringe from two (2) new medication containers/vials without the benefit of sanitizing the rubber diaphragm with an alcohol pad. Interview with RN #4 on 3/2/16 at 1:55 PM noted that he/she believed that the rubber diaphragm was sterile when the vial was first opened. The facility policy for sterile preparations directed to prepare the vial by removing protective caps and cleaning the port diaphragm with an alcohol pad.



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