Preparing for Compliance with USP 800: Unreimbursed Efforts of an Oncology Practice

April 2016, Vol 6, No 4
Robert D. Orzechowski, MBA, SPHR, SHRM-SCP
Chief Operating Officer, Lancaster Cancer Center, Lancaster, PA

This is the third article in our series on the US Pharmacopeia Convention (USP)’s “General Chapter 800 Hazardous Drugs” (USP 800) regulations regarding handling hazardous drugs. Our goal is to provide information primarily on the unreimbursed compliance efforts of one private medical oncology practice. This series, like our program, is a work in progress.

Our first article appeared in the January 2016 issue of this journal.

The second article appeared in the February 2016 issue of this journal, in which we shared more details of our practice’s journey toward compliance with the various USP 800 regulations for handling chemotherapy.

As a reminder, our private, independent medical oncology practice has been serving our area for >35 years and 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 the competition with community cancer care physicians. We are subject to most of the same regulations as all entities that handle hazardous drugs, as it should be. This article focuses on our second (and most recent) certification since the initial testing in the summer of 2015.

Preparing for Our Second ISO Certification

After the construction of both rooms—the buffer (or ante) room and the chemotherapy-mixing room—­we engaged a firm to conduct various tests, with the goal of obtaining certification from the International Standards Organization (ISO). These standards can be identified in part by a measurement known as “particulates per cubic meter by micrometer size.”

Testing is also necessary for design and construction, biocontaminates, molecular contamination, clean room operations (workflow), and airflow and pressures. The buffer room is 12 feet by 12 feet, and the chemotherapy-mixing room is 10 feet by 12 feet.

The certifying vendor submitted a proposal similar to its first proposal for our second effort to test air quality, surface viability, particle counts, and smoke studies.

Our initial round in July 2015 consisted of testing the Biological Safety Cabinet, testing the surfaces and air sampling in both rooms, fingertip testing of all employees who mix the drugs, Magnehelic differential pressure gauge calibrations, a videotaped smoke study, performing operational particle counts, and doing 4 bacterial colony identifications. Subcultures and Gram stains for potential microorganisms were performed at an additional cost.

The testing revealed minor levels of an unidentified mold on one surface. Mold colonies are automatically identified, and no further action is necessary if the results are below the exceeded concern level, as set by regulations. A microorganisms report includes 4 types of bacteria; if they exist beyond the exceeded concern level, further testing is advised. Fortunately, our results were acceptable. Certain remediation efforts, however, were required, including workflows, policies, and procedures; they continue to this day.

Recommendations Based on Our Remediation Experience

Based on our remediation efforts to the test results, we can offer the following recommendations for oncology practices:

  1. Follow a robust cleaning regimen of all hard surfaces every other week; we settled on bleach-based products where possible
  2. Keep all cardboard and “softer” materials out of the buffer room
  3. Minimize staff traffic in and out of both rooms
  4. Replace tacky mats once or twice daily, depending on traffic
  5. Wipe clean and cover any hard-surface items that are returned to the buffer room, such as the small cart used to transport unpacked drugs
  6. Wear longer, high-quality gowns, and don and doff in the buffer room
  7. Wear bouffant caps in the mixing room; they have an elastic band that is waterproof
  8. Wet mop the infusion suite floor twice weekly, or more frequently, with a cleaning solution
  9. Regularly change the cleaning tools and devices, such as mop heads, when wear and tear is obvious
  10. Use lint-free, nonshedding disposal wipes as our preferred cleaning cloth.

Updating Workflows and Procedures

Because we had to comply with so many physical plant changes and many new standards, we needed to review our workflows, tasks, and job-specific essential functions. We reviewed the entire process for receiving our drug inventory, including where it enters the suite, the opening of boxes, and order verification, which must all occur outside either room. All boxes, bubble wrap, and other packaging are controlled in the area immediately next to the receiving area. The drugs are then delivered to the computerized drug cabinets located in the buffer room. The buffer room has a self-closing door with a small window, and there are sticky mats on either side to help control particulates from entering the buffer room.

Access to the mixing room is only possible through the buffer room. Doors to both rooms have automatic closing mechanisms. Access to the buffer room is limited to the nursing and dispensary personnel. Drugs are sent from the buffer room to the mixing room via a sliding glass door with a small ledge beneath it in each room. This door is kept closed at all times and is opened only to pass drugs that are to be reconstituted, because maintaining proper air pressure in each room requires the restriction of airflow into the mixing room and between the infusion suite and the buffer room. Air pressure issues must be addressed during the design phase, and specifications exist for the proper calculations. The room size; HVAC (heating, airflow and venting, and air conditioning) systems; ducting; airflow; and air returns must all be designed as part of a larger environment.

No one may enter the mixing room without a thorough hand washing; if they do enter, they must wear clean gowns, gloves, a mask, and a bouffant head cover. Nothing is kept in the mixing room that anyone other than the mixing personnel needs. The mixing room has a telephone in it if communication with the mixing person is necessary.

Our second testing occurred in January 2016. Our results were nearly all within ISO 5 and ISO 7 standards. A very minor finding of one isolated bacteria on a fingertip testing exercise was the only remarkable finding, and this did not rise to an exceeded concern level that required further testing. Regardless, we took it seriously, and we revised how we transport, store, and open a box of gloves. We attribute this most favorable finding from the second round of testing to the remediation efforts developed by the Exposure Control Committee, the nursing team, and to the diligence of everyone to comply with our revised workflows and standards.

Continuing Efforts

Our efforts continue, and we are aware of the dynamic nature of the changing processes, our learning curve, the ability to remain informed of changes, the importance of teamwork and communication, and the relevance of well-designed workflows and individuals’ essential functions. Several standards pose real and serious challenges for us all, including in the medical surveillance section, which we hope to address in a subsequent article in this journal.

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