A robust, cohesive environmental monitoring program is central to ensuring the stability of compounded sterile preparations (CSPs) and achieving USP <797> compliance. However, depending on in-house staffing levels and knowledge of specific <797> environmental monitoring requirements, using internal resources to perform environmental monitoring may prove challenging for some hospitals.
Rockford Memorial Hospital is a 396-licensed bed tertiary care center and Level I trauma center located in Illinois. The hospital has a large neonatal intensive care unit, and within the past five years built two USP <797>-compliant cleanrooms with safety redundancies; the two cleanrooms are connected in the center by a single anteroom. The facility also has a negative pressure chemotherapy cleanroom in a separate location. A large number of CSPs are prepared in our cleanrooms daily, and ensuring the rooms are truly clean is a high priority. Because <797> contains specific requirements for air and surface sampling to ensure the safety and sterility of CSPs, and because internal staff does not have the time or training to properly perform environmental monitoring in-house, our hospital outsources its environmental monitoring services to a vendor that specializes in ensuring safety and compliance in the cleanroom environment.
Challenges to Effective Environmental Monitoring
Numerous challenges exist to achieving effective environmental monitoring. At Rockford, our primary considerations include regulatory compliance, cost containment, and staff training and retraining requirements; however, safeguarding compounded medications and ensuring regulatory compliance are our most significant concerns.
The serious consequences of not maintaining effective cleaning practices in the cleanroom are well known. Last year’s deadly fungal infections associated with contaminated compounded methylprednisolone injections, which killed 55 patients and sickened over 740, highlights the necessity of robust cleaning practices and effective environmental monitoring.1 Armed with this knowledge, and because we were unable to provide the depth of monitoring we felt necessary to adequately ensure safety using existing staff, outsourcing environmental monitoring was an attractive option. In addition, we found there was a cost benefit of outsourcing environmental monitoring services rather than performing the service in-house. For example, in order to perform environmental monitoring ourselves, we would need to purchase additional testing equipment, including an incubator. We decided that the steep costs of purchasing and maintaining this equipment, and training and retraining staff on correct procedures, was cost-prohibitive, and that hiring outside environmental monitoring services would be both a prudent and safe choice.
Another important consideration was the knowledge that the outside vendor focuses only on environmental monitoring—and thus is able to perform their services at an expert level—while in-house staff must focus on numerous and varied responsibilities and have less environmental monitoring training. The peace of mind that comes with knowing the true experts are monitoring our cleanrooms reinforced the decision to outsource services.
Choosing a Vendor
Our primary considerations when choosing an outsourced environmental monitoring partner included the vendor’s reputation, years in business, experience and expertise, and reporting capabilities. To accurately evaluate a vendor, be sure to request references from facilities of a similar size and scope as your hospital, and follow up with these references to evaluate the vendor’s skills, expertise, and professionalism. The positive references we received, coupled with the vendor’s excellent reputation in our area, were the prime considerations that dictated our choice of vendor.
Environmental Monitoring Process
Our environmental services vendor performs air and surface sampling in our hoods and cleanrooms every six months, including viable air and surface sampling for both bacterial and fungal contamination, media fill validation, and glove fingertip sterility testing per USP <797> guidelines. We also require our in-house environmental services department to perform redundant sampling every quarter to best ensure safety. Because our in-house environmental services department performs air sampling in other areas of the hospital, including the OR, it was not necessary to purchase the equipment to perform this additional testing. Initial staff training is performed in-house using an ASHP sterile product preparation continuing education training video, with additional staff training performed by our vendor.
Our vendor performs a personal aseptic assessment of each compounding staff member using an aseptic technique evaluation checklist. The checklist covers issues such as proper gowning procedures, preparation of work area, collecting and transferring compounding supplies, aseptic operations, as well as antineoplastic drug compounding procedures. With this checklist approach, the vendor can, for example, confirm that the compounding technician consistently removes the outer wraps from the medication before entering the cleanroom, as required. Employee aseptic assessments are performed yearly on all compounding personnel. A trypticase soy broth sterility test medium is used to evaluate microorganism growth promotion and to test each employee’s technique when manipulating CSPs.
Benefits of Outsourcing Environmental Monitoring Services
Shortly after our cleanrooms were built, the value of utilizing outsourced environmental monitoring services became apparent when one of the water pipes in the ceiling above a cleanroom burst, causing water to leak into the cleanroom. Because we built redundancies into our layout, we were able to move our equipment out of that cleanroom and work in the other while the pipe and ceiling were repaired. Our environmental services staff then cleaned the room, and I asked our vendor to come and recertify the room where the pipe had burst.
The vendor collected particle counts and viable air samples for both bacterial and fungal contamination, and evaluated the level of microorganisms. While the results determined that the cleanroom was clean, the results in the anteroom came back with positive findings for gram negative rods and fungal spores, which likely developed as a result of moving supplies from one cleanroom to the other. Although we were familiar with bacteria, we were not clear on certain parameters—for example, how many colony-forming units (CFUs) per plate were acceptable for different ISO classes.
When addressing this event, the expertise of our outsourced environmental services partner proved invaluable. Upon receiving the positive results in the anteroom, our vendor asked us to do another thorough cleaning of the cleanrooms and anteroom and then they repeated the testing. This time, the tests came back negative. Without the expertise of the environmental services vendor, we would have assumed that the cleanroom initially had been cleaned adequately and resumed compounding in potentially unsafe conditions. Moreover, if left unaddressed, the contamination may have become more serious. Although we were technically never out of compliance, this experience reinforced the value of partnering with a quality vendor with the capability to uncover environmental concerns.
Routine Equipment Maintenance
In addition to the important benefit of utilizing an outsourced environmental monitoring vendor in emergencies, these services also can be useful for uncovering problems through routine equipment maintenance. During a recent routine biannual hood certification, our vendor alerted us to a small hole in a filter that needed to be replaced. This type of imperfection would have been easy for in-house staff to miss without careful review.
Enhanced Reporting Capabilities
Systemized reporting capabilities support our environmental monitoring efforts. The vendor supplies regular reports on the monitoring of our hoods, air and surface sampling, and a yearly assessment of each technician’s compounding skill compliance. The hood certification reports include HEPA filter integrity testing, air velocity measurements, and smoke pattern tests. Viable air and surface sampling for both bacterial and fungal contamination is conducted for hoods and compounding rooms per USP <797> guidelines. The completion of media fill validation, aseptic technique evaluation, and glove sterility testing is also required for all compounding staff. These reports are filed and stored for quick access in the event of an audit.
TJC Auditing Assurance
Another significant benefit of utilizing outsourced environmental monitoring has been the assurance that our practices are compliant. During two recent TJC surveys, as well as state inspections, the inspectors have been satisfied that our environmental monitoring was sufficient upon review of our comprehensive reports and policies and procedures. After review of our policies and records we passed both surveys; the surveyors verified that we were in compliance and praised our efforts to ensure cleanroom cleanliness and CSP safety.
Evaluation of the costs associated with outsourcing environmental monitoring reveal the service to be cost effective for our facility. Purchasing additional equipment is not necessary, nor is overseeing staff training and retraining each year. In addition, as pharmacists who routinely purchase expensive medications that take up a large portion of the pharmacy budget, the comparatively low cost of contracting with a vendor to perform environmental services—coupled with the surety and confidence we have that our compounding process is performed in a safe environment—have proven the decision to be practical.
Contracting for Environmental Monitoring Services
The type of contract most appropriate for each hospital depends on the depth and breadth of environmental services required. A large facility that requires its vendor to perform all environmental monitoring services may be best served by a contract specifying a flat fee per month for all services rendered, while less comprehensive services may be best negotiated with a fee-per-service agreement. Although our vendor performs all of our environmental monitoring services, at Rockford we made the decision to contract for each service individually to avoid paying for services we do not require.
Although it is not possible to guarantee there will never be an incident with a CSP produced in our cleanroom, appropriate environmental monitoring, performed by a knowledgeable outsource vendor, has provided significant peace of mind that our hospital is doing everything possible to prevent patient harm from contaminated CSPs. When considering the potential consequences of not maintaining cleanliness in the compounding environment, the costs of partnering with an effective environmental services vendor are well worth the price.
Curt Lesher, RPh, is the director of pharmacy at Rockford Memorial Hospital in Rockford, Illinois. In addition to his hospital responsibilities, Curt assists other institutions in the application of quality improvement and statistics with Care Education Group of Chicago. He received his bachelors degree from the University of Illinois and has worked in pharmacy management for over 25 years.
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