In Massachusetts, medical and biological waste is regulated by the Department of Public Health’s, Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII) [105 CMR 480]. There are various waste management, disposal, disinfection, and record-keeping requirements in the Sanitary Code. In this blog we’re going to focus on important things to consider to ensure your medical and biological waste record-keeping is compliant.
Generators of medical or biological waste are required to maintain a waste record-keeping log. On the cover, it must include the following: the words “Medical/Biological Waste Record-Keeping Log” in large print, the name of the facility generating the waste, and when applicable, the name of the owner and operator. Per the Sanitary Code requirements, the log must contain the documentation described below.
- Medical/biological waste manifests need to be included for each waste shipment for off-site treatment, and they must be signed by a Department of Transportation (DOT)-trained hazmat employee. Waste generators are responsible for confirming that the waste was received by the off-site treatment facility within 30 days of shipment. The signed biowaste manifests (or tracking forms) that are returned by the treatment facility serve as proper documentation.
Under the Sanitary Code, a copy of all manifests is required to be kept on file for a period of 375 days after the material is accepted by the transporter. However, the Code defers to any stricter federal requirements such as DOT’s which specify that manifests must be maintained for three years.
Note that hazardous/chemical waste manifests should not be included in the medical/biological waste record-keeping log. Rather, they should be filed separately such as in a binder dedicated to hazardous waste manifests or in an appropriate filing cabinet.
- Record-keeping log forms are required to be maintained to document the disposal of medical or biological waste and to serve as confirmation of receipt by an off-site treatment facility. The log forms are used to track waste generator and transporter information, the date of shipment, the type and quantity of waste, container type, and verification that shipping papers and tracking forms are on file.
Note that for each waste shipment, the printed name and signature of the person who offered the waste for transport (i.e., who signed the waste manifest) needs to be included.
In cases where facilities use steam disinfection/autoclaving or another approved method to treat their medical/biological waste on-site, a similar record-keeping log form must be maintained. This version is used to track the date and type of treatment, process parameters, and quantity of waste. In addition, it must include the printed name and signature of the person responsible for treating the waste.
Logs for both treatment methods must be retained for three years. The State has published approved record-keeping log templates for both on-site and off-site treatment.
- Safety Data Sheets (SDS) are required to be included in the log for chemicals used for medical/biological waste disinfection. A company’s Institutional Biosafety Committee (IBC) is responsible for approving the disinfectants used for the on-site treatment. It is common for bleach to be approved, but if additional products are authorized by the IBC and put into use, their SDSs must also be on file.
- IBC documentation needs to be retained with the record-keeping log. This includes a list of all IBC members, past and present, with their credentials. In addition, minutes of all IBC meetings must be maintained along with any recommendations made by the Committee. Where this is not practical due to the amount of documentation, it is generally acceptable to add a note to the log that indicates the location of the IBC roster, members’ résumés, and meeting minutes.
- Spill and accident procedures are also required to be filed in the medical/ biological waste record-keeping log. As an alternative, a note is commonly added stating that spill and accident procedures can be found in the facility’s Biosafety Manual & Exposure Control Plan and/or Emergency Action Plan or Contingency Plan as applicable.
For more information on medical/biological waste record-keeping requirements, or for help implementing them at your facility, please contact us.
This blog was written by Beth Graham, Safety Partners’ Director of Quality, Research, and Training.
