Last month we introduced the topic of the US Pharmacopeia Convention (USP)’s “General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings” (USP 800), with the first article in this series. In this month’s article, I’d like to share with you our practice’s journey toward complying with the various regulations of USP 800 for handling chemotherapy.
This article series, like our program, is a work in progress. The purpose of this series is not to take issue with the regulations themselves, but to reflect on firsthand experience from our practice. Several excellent presentations and materials have been made available by others that cover the history and details of the USP 800.
Our private, independent medical oncology practice, which has been serving our area for more than 35 years, is, geopolitically speaking, in a “David and Goliath” situation. Area hospitals dominate our market space, and we know what advantages they have, and how they bear on competing with community cancer care physicians. Regardless, we are subject to most of the same regulations as all entities that handle hazardous drugs, as it should be.
Review of Our Workflow
In mid-2013, our Exposure Control (“Safety”) Committee finished a thorough update of our Occupational Safety and Health Administration (OSHA) manual, which included an inspection of our physical plant. We then began to take a closer look at many of our workflows, procedures, and habits.
Based on this review and the resultant gap analysis, we realized that among other things, we could improve our safety and exposure levels in handling hazardous drugs. We did not consider ourselves covered by the USP’s “General Chapter 797—Pharmaceutical Compounding—Sterile Preparations” (USP 797), but we did consider ourselves regulated by OSHA’s standards in this area. We also were desirous of meeting the Oncology Nursing Society’s safe chemotherapy handling standards whenever possible.
Structural Upgrading for Compliance
Our 10-foot by 12-foot chemotherapy mixing room contained our Biological Safety Cabinet, as well as our computerized drug-dispensing cabinet and a small refrigerator. Access to this room was through a doorway directly from the infusion suite. Airflow pressures were not monitored, and no air quality device was in operation (eg, to measure carbon dioxide levels). Furthermore, the Biological Safety Cabinet was not externally vented and was instead self-contained and filtered. The Biological Safety Cabinet, however, received certifications on a regular schedule per manufacturer and industry standards.
As we were investigating the conditions of the heating, airflow and venting, and air conditioning (HVAC) systems and the existing exposure control standards, the proposed USP 800 regulations were released in March 2014. While reviewing the regulations, it became obvious that our 11,400-square-foot physical plant, workflows, and procedures had to be improved. We consulted OSHA, the National Institute for Occupational Safety and Health, and ONS, as well as other resources, for information, including relevant specifications, standards, and opinions. We also discovered a record of citations and sanctions by regulatory entities of various facilities in the United States, which only added to our focus and motivation to address what we believed were opportunities to begin our journey toward compliance with increasingly stringent standards.
Addressing the Regulations’ Challenges
The USP 800 proposed regulations present real and significant challenges to everyone. We committed to a goal of maximum feasible compliance on an aggressive schedule and within our financial and operational capabilities. Our first step was to gain physician appreciation and recognition of the situation and support for our efforts. We then met with our landlord, because we lease our space. The landlord shared its design, engineering, and various facility specialty personnel with us for consultations and planning meetings.
The final plans were approved in spring 2014, and construction ended in June 2014. Certification, including samplings and testing (including for air quality, surface viability, particle counts, and smoke studies), occurred in early July 2014. Those results were then sent to laboratories for analysis, and the reports were returned to us in August 2014. Fortunately, no samples fell below acceptable levels. Certain remediation efforts were required, however, and they continue to this day in the form of workflows, policies, and procedures.
From our understanding of the regulations, we determined that a 12-foot by 12-foot buffer room or “anteroom” was needed, as was a redesign of our current chemotherapy mixing room (our “clean room”). We had to build the buffer room by taking space from medical records personnel and from some storage space that was adjacent to the mixing room. We set goals of the buffer room being an ISO 7 (formerly class 10,000) level clean room, and our mixing room becoming an ISO 5 (formerly class 100) level room. These rooms require the use of certain materials for covering the floor, walls, and ceilings. The ideal approach was to aim for rooms that were waterproof, except for the air supply and exhaust devices.
The HVAC components included venting the Biological Safety Cabinet through the ceiling and up through the building’s roof. Our existing Biological Safety Cabinet was fitted with the necessary exhaust cowling, ducting, fans, and alarms to accomplish this. We also had to install a larger 5-ton air handler and heat pump for the infusion suite and airflow devices for inbound and return air exchange in the buffer and mixing rooms. HEPA filters were installed in the air handlers.
Programmable thermostats were installed, along with upgraded ducting, refrigerant devices, and ceiling diffusers. Magnehelic differential pressure gauges were installed in both rooms and in the infusion suite to control and document negative and positive air pressures and air quality.
The Cost of Compliance
Certifications were and continue to be performed by the company that has been responsible for certifying our Biological Safety Cabinet over the years. As for the company’s costs, not including the cost of the exhaust system alarms, their expense was less than $2000. Their certification included various environmental scanning in the buffer and mixing rooms, the Biological Safety Cabinet itself, gauge calibrations, multiple fingertip testing, particle counts, and a videotaped smoke study. Subsequent lab work was performed on all samples, and those costs were not included in the certification effort, but we wanted to take the samples’ analyses to the next level of precision for our own records.
The total project costs so far are difficult to specify in a line-item format. For purposes of this article, suffice it to say that the cost for design, HVAC, room construction and modifications, and the necessary specialized materials, including 2-part epoxy paint, seamless flooring, and special ceiling tiles, was approximately $50,000 to $60,000. This does not include the current or future hard cost of certifications, sampling analyses, the anticipated compliance efforts for employee medical surveillance, specialized drug-handling devices and supplies, and ongoing clean room cleaning efforts. There are also soft costs of productivity impact that result from the redesigned workflows, supplies, and materials that are necessary to maintain the ISO standards.
The Challenges Ahead
Because of the extent of the effort required by our employees, as well as the expense involved to date, we have all come to appreciate the focus on employee safety and compliance with regulations and standards. Our efforts continue, and we are aware of certain shortcomings involving complying with the revised and still proposed USP 800 regulations. Several standards pose real and serious challenges for us all, including the medical surveillance section.
Each medical practice will have its own unique physical plant, staff, financial, and operational considerations. Your costs, processes, and experience will govern the extent to which your own compliance efforts are designed and achieved. Physician support, management leadership, and an engaged staff are critical to any successful company-wide initiative, especially of this magnitude.
Numerous resources exist for anyone seeking to understand the relevant regulations and standards. Among the sources of information are the Centers for Disease Control and Prevention, Pharmacy Purchasing & Products magazine, the Association of Community Cancer Centers, ONS, OSHA/National Institute for Occupational Safety and Health, American Society of Clinical Oncology, the Hematology/Oncology Pharmacy Association, and the ISO published standards, manufacturers, and distributors of the supplies and equipment that are deemed necessary for the work involved. Furthermore, several organizations have submitted responses and comments to the USP 800 regulations, which can be found on the USP’s website, at www.usp.org/.