HospitalInspections.org

Based on observation, a review of facility documentation, and staff interviews the facilities governing body failed to ensure the hospitals quality program assessed services provided by an outside environmental monitoring company to identify quality and performance issues. The finding includes:

During a tour of the pharmacy on 10/15/14 at 10:00 AM, a review of the facility environmental monitoring reports from January 2014 - October 2014were conducted. It was noted that an independent company had conducted monthly testing of the compounding area of the pharmacy to determine if microbial contamination was present. The monthly reports identified site samples, total number of colonies, with genus identification in multiple locations with both surface and air sampling. Interview with the Director of the Pharmacy on 10/15/14 at 10:00 AM indicated he spoke with the microbiologist from the company and was told that the findings did not require an action with the one exception of the floor sampling. The recommendation was to place a "tacky" mat on the floor entrance to the clean room in September of 2014 where compounding occurred, as most of the genus identified was located in this area. Further interview with the Director of the Pharmacy indicated he did not discuss the results of the monthly testing with the quality committee to determine the severity of the problem, interventions that may have been needed and/or opportunities for improvement to effectively deliver quality care and ensure patient safety. Interview with the Vice President of Nursing on 10/29/14 at 1:30 PM identified the governing body was not made aware of the environmental testing that was conducted in the pharmacy to ensure monitoring, improvement activities, and sustainability of quality problems. The hospital bylaws dated 12/20/07 directed in part, the quality coordinating council would monitor the performance improvement activities carried out within the hospital. Further review of the bylaws identified the governing body would be responsible to review infection control as it related to the development of a mechanism for monitoring and reporting environmental conditions with infection potential.

Based on a review of the hospital documentation and interviews with hospital personnel, the facility failed to assess and/or analyze environmental testing conducted in the pharmacy and/or failed to incorporate the hospital's quality improvement program to ensure patient safety and quality of care. The finding includes:

During a tour of the pharmacy on 10/15/14 at 10:00 AM a review of the facility environmental monitoring reports were conducted. It was noted that an independent company had conducted monthly testing of the compounding area of the pharmacy to determine if microbial contamination was present. The monthly reports from Janurary 2014-October 2014 identified site samples, total number of colonies, with genus identification in multiple locations with both surface and air sampling. Interview with the Director of the Pharmacy on 10/15/14 at 10:00 AM indicated he spoke with the microbiologist from the company and was told that the findings did not require an action with the one exception of the floor sampling. The recommendation was to place a "tacky" mat on the floor entrance to the clean room in September of 2014 where compounding occurred, as most of the genus identified was located in this area. Further interview with the Director of the Pharmacy indicated he did not discuss the results of the monthly testing with the quality committee to determine the severity of the problem, any interventions that may have been needed and/or opportunities for improvement to effectively deliver quality care and ensure patient safety. The hospital's performance improvement management plan directed in part, a performance improvement plan specific to the department's scope of care and to ensure the deployment of strategies based on measurement and assessment of process and outcomes. The chief executive officer, senior leadership and the executive leadership team would be responsible for assuring the identified key projects are reflected, measured and evaluated in the performance improvement plan with outcomes documented.

Based on review of facility documentation, review of facility policy, review of manufacturer's recommendations, observations and interviews, the facility failed to ensure that pharmacy equipment inspections and/or cleaning maintenance was conducted/documented as per manufacturer's recommendations, and/or facility policy and/or state law. The finding includes:

A tour of the pharmacy department was conducted with the Director of Pharmacy on 10/27/14. Observation on 10/27 14 at 2:00 PM identified that the pharmacy had three glove compounding isolators. Isolator #3 had a maintenance sticker dated for 9/2014 on the outer right side of the isolator. Review of isolator inspection documentation on 10/28/14 at 2:05 PM indicated that all three isolators had HEPA filters and air velocity testing, by Company #2 on 1/20/13 and 7/8/13, testing was not conducted for January 2014. A change in vendor on 9/24/14 identified that Company # 3 only tested Isolators #2 and # 3, and that Isolator # 1 was not tested. Interview with the Director of Pharmacy on 10/28/14 at 2:05 PM noted that there was a glitch in the testing schedule, Company #2 did not test the equipment in January 2014 as per contract and Company #3 was only capable of testing the positive pressure isolators, Isolators #2 and #3.
The facility submitted a corrective action plan on 10/28/14 that included testing of the negative pressure isolator, Isolator #1, scheduled for 10/29/14. The facility IV Infection Control policy directed that, barrier isolators are inspected and certified every six months.

Based on review of facility documentation, review of facility policy, and interviews the facility failed to ensure that the infection control department was informed of positive mold cultures in the medication compounding area. The finding includes:

1. A tour of the pharmacy department was conducted on 10/27/14 at 2:00 PM with the Director of Pharmacy. Observation on 10/27/14 at 2:00 PM identified a door at the back of the department lead to a room that contained, in part, three isolators for medication compounding. Review of facility contracts and/or environmental monitoring reports on 10/27/14 indicated that Company #1 performed environmental culturing in the pharmacy department as per facility contract. The monitoring reports further noted that 1 to 3 mold spores were cultured on the surfaces and/or floor and/or in the air of the medication compounding room (not in the compounding isolators) in January, February, May, June, July, August, and September 2014. The monitoring reports further documented that the Director of Pharmacy did not take steps to remediate the presence of mold until June 2014 when cleaning processes were reviewed, and/or when dynamic testing was conducted in August 2014 and/or the institution of a sticky mat" in September 2014. Review of Pharmacy and Therapeutics committee minutes from 1/2014 to 9/2014 lacked documentation of the mold spores and/or the steps taken by pharmacy to remediate the mold. Review of Infection Control (IC) meeting minutes from 1/2014 to 9/2014 lacked documentation of the pharmacy cultures and/or remediation. Interview with the Director of Pharmacy on 10/27/14 at 2:30 PM identified that, although the pharmacy mold levels were far below actionable levels, he/she consulted with the contracted microbiologist for ideas to eliminate/decrease the mold. Review of IC meeting minutes and further interview with the Director of Pharmacy on 10/27/14 at 2:30 PM noted that the IC team had never been made aware of and/or been involved in environmental culturing results/remediations as the levels were non- actionable. Interview with the Infectious Disease Physician on 10/29/14 at 11:12 AM indicated that, going forward, he/she would like to see a grid to reflect known unacceptable culture levels and the pharmacy culture results/trends. The facility IC plan identified that the program was an institution- wide program whose main objectives are the prevention and control of infections. The IC plan included a major function to design and execute routine surveillance data collection and analysis activities and to develop, review, and revise hospital- wide infection prevention policies and procedures. According to the USP 797, highly pathogenic microorganisms, to include mold, must be immediately remedied regardless of the colony forming unit count, with the assistance of a competent microbiologist, IC professional, or industrial hygienist.
2. A tour of the pharmacy department was conducted with the Director of Pharmacy on 10/27/14. Observation on 10/27/14 at 2:00 PM identified that Pharmacy Technition #1 placed items in the antechamber of Isolator #3, sprayed the antechamber with sterile 70% Isopropyl alcohol and after donning the isolators gloves/sleeves, moved the items from the antechamber to the main chamber and began the medication compounding procedure. Following the procedure, Pharmacy Technition #1 moved the items to the antechamber, removed his/her gloved hands from the isolator's gloves/sleeves and removed all items from the antechamber. Pharmacy cleaning logs identified that Glove Box A and Glove Box B (Isolators #2 and #3) were cleaned on each shift. The cleaning logs lacked evidence of any additional cleaning of Isolators #1 and/or of cleaning of the negative pressure isolator (Isolator #1). In addition documentation could not be provided for required isolator glove changes. Interview with the Director of Pharmacy on 10/27/14 at 2:30 PM indicated that isolator gloves are changed daily and on the morning shift and that this was not documented. He/she further noted that additional cleaning of isolators was performed if soling was noted in the chamber and was not performed between compounding- sterile preparations (CSP). Interview with the Performance Improvement Specialist on 10/28/14 at 8:55 AM noted that the pharmacist would change the gloves in Isolator #1 each day the isolator was used, which was approximately once a week, and that this was not documented. Manufacturer's recommendations for the IV isolators directed cleaning and disinfecting the isolator at the beginning of each shift and cleaning and sanitizing the isolator between CSP. The IV room IC policy directed that barrier isolator gloves will be changed every other day.
3. A tour of the pharmacy department was conducted with the Director of Pharmacy on 10/27/14. Observation on 10/27/14 at 2:00 PM identified that Pharmacy Technition #1 placed items in the antechamber of Isolator #3, sprayed the antechamber with sterile 70% Isopropyl alcohol and after donning the isolators gloves/sleeves and a 20 second lapse in time, moved the items from the antechamber to the main chamber. Interview with Pharmacy Technition #1 on 10/27/14 at 2:08 PM noted that, after the antechamber and items therein were sprayed with the alcohol solution, items remained in the antechamber for as long as it took to don the isolator gloves/sleeves, enter the main chamber and transfer the items. Interview with the Director of Pharmacy on 10/28/14 at 2:05 PM noted that items needed to remain in the antechamber for 15 to 20 seconds after the Isopropyl alcohol spray. Manufacturer's recommendations for the IV isolators directed that after cleaning and decontamination, the product is to remain in the transfer chamber (antechamber) receiving a sterile shower for a period of not less than 30 seconds prior to moving them to the main working chamber.
4. A tour of the pharmacy department was conducted on 10/27/14 at 2:00 PM with the Director of Pharmacy and identified that the facility had three isolators for medication compounding. Review of the annual pharmacy IV competency evaluations identified that all staff received the annual aseptic technique test and challenge kit competency testing in the fall of 2013. The facility IV Room IC policy, revised in 1/2014, directed that all pharmacy personnel must undergo performance evaluations (competencies) including gloved fingertip sampling and media fill testing every 12 months. Interview with the Director of Pharmacy on 10/27/14 at 2:40 PM noted that staff had not yet undergone gloved fingertip sampling as competencies are conducted in the fall. According to the USP 797 (2012), all compounding personnel shall successfully complete an initial competency evaluation and gloved fingertips/thumb sampling no less than 3 times before initially being allowed to compound CSPs and a re- evaluation shall occur at least annually.