Reprinted with permission from Birmingham Medical News (November 2022).
In August 2022, the Alabama Department of Environmental Management (“ADEM”) published proposed changes to its rules for public comment. Specifically, the rules affect how a healthcare provider stores medical waste. If the proposed rules go into effect, many healthcare providers will either need to change the frequency with which they have medical waste picked up or they will need to obtain a permit as a storage facility. Consequently, it is important to understand how the rule changes might impact a practice, facility or provider.
What is Medical Waste?
Medical waste is defined by ADEM rules as “a solid waste or combination of solid wastes, which because of its infectious characteristics, may either (a) cause, or significantly contribute to, an increase in mortality or an increase in serious irreversible or incapacitating reversible illness or (b) pose a substantial present hazard or potential hazard to human health or the environment when improperly treated, stored, transported, disposed, or otherwise managed.”
Additionally, a medical facility or person who produces or generates medical waste is a “Medical Waste Generator” under ADEM rules. This includes hospitals, nursing facilities, clinics, dialysis clinics, blood banks, dental offices, surgical clinics, medical buildings, health maintenance organizations, home health agencies, physician offices, laboratories, emergency medical services, veterinary clinics, research and manufacturing facilities. Under the current rules, where more than one person (e.g., doctors with separate medical practices) is located in the same building, each individual business entity is a separate generator.
What are the Changes to the Rules?
As a Medical Waste Generator, healthcare providers are already required to provide information to ADEM about its operations, including a written plan on the management of the waste it produces. Under the new rules, a Medical Waste Generator will be required to register with ADEM, but there does not appear to be any fee associated with the registration. However, the changes to the rules create additional burdens by requiring a formal management and training program.
The proposed rules require a Medical Waste Generator to develop a training program for facility personnel whose “duties have a direct effect on medical waste management and/or medical waste accumulation.” There is no further explanation or identification as to which personnel that applies, but the training program requires “classroom or on-the-job training” that teaches compliance with ADEM rules on handling medical waste. This new training will add additional regulatory requirements for healthcare providers already subject to significant scrutiny for infection control and occupational safety measures.
Under the Generator rule, a healthcare provider cannot store medical waste beyond seven calendar days unless the waste is refrigerated, and then, it can only store the waste for 30 days. If a healthcare provider does store it beyond seven days unrefrigerated or for longer than 30 days refrigerated, the healthcare provider then becomes a “Storage facility” under ADEM’s rules. Many healthcare providers do not generate enough medical waste to warrant waste transport pick-up on a weekly basis nor do they store their medical waste in refrigerated storage containers. Therefore, many providers will become storage facilities.
As a Storage Facility, Proposed Rule § 335-17-4-.01 Storage of Untreated Waste states that those healthcare providers with no ability to refrigerate waste and who are unable to have waste transported from their facility or office within seven calendar days will be required to obtain a permit from ADEM as a Storage Facility. If a healthcare provider is able to refrigerate its medical waste but stores it longer than 30 days, it also is considered a Storage Facility. Unlike registration as a Generator, a Storage Facility registration comes with an initial fee of $2,630, and requires local government approval involving a hearing and public comment in that local jurisdiction. See ADEM Proposed Rules §§ 335-17-8-.02 and 335-17-8-.03. One helpful provision is that storage of medical waste begins after a shipping container is prepared for shipment, and under existing rules, storage does not begin when it is placed in a container at the point of generation, such as a patient’s room, operating room or lab.
These new rules will likely result in many healthcare providers changing the way in which they store medical waste by either creating a means to refrigerate medical waste or paying for more frequent transport pickups. Either option chosen will not be inexpensive. In addition to the potential financial impact on the healthcare provider, the transport companies with whom those providers contract will likely be unable to meet an increase in demand that these rules will generate.
The rules were published in the Alabama Administrative Monthly on September 1, 2022, and public comments could be submitted to the agency through October 13, 2022. There was also a public hearing held at ADEM on October 13, 2022, to allow for additional presentations or comments from interested stakeholders. Several organizations and associations representing healthcare providers in the state submitted public comments in opposition to the proposed rule because of the potential impact. One organization requested that ADEM submit an economic impact statement before adopting the rule. Under Alabama law, if a party negatively affected by the rule change requests an economic impact analysis, the agency must prepare and submit a business impact analysis.
The earliest ADEM could consider adoption of these rules would be at the December 9, 2022 meeting.