Section 480.500 - Procedures; Records; Record-keeping LogWaste generators, small-scale generators and Sharps Collection Centers shall:
(A) Develop written procedures, as applicable, for rendering waste noninfectious and to assure effectiveness and compliance with the requirements set forth in 105 CMR 480.000. These shall include: (1) Procedures for the identification of types, quantities and disposition of regulated medical or biological waste including identification of waste approved for disposal in accordance with 105 CMR 480.200(A)(1);(2) Procedures for safe handling and transportation within the facility from the point of generation to the point of storage and/or treatment;(3) Confirmation of U.S. Department of Labor, Occupational Safety and Health Administration's Blood borne Pathogen Training for all individuals who may potentially handle medical or biological waste;(4) The listing of a contact name and emergency contact number for an individual(s) who either has knowledge about the waste material, including emergency response information, or who has immediate access to a person who possesses such knowledge and information;(5) A description of on-site regulated medical or biological waste storage areas, including those used for short term storage, which detail the ventilation and capacity of the storage areas, and the duration waste will be retained in each area.(B) Maintain a current record-keeping log, on forms provided by the Department or alternate forms, if approved by the Department and which provide at a minimum all of the same required information, for all medical or biological waste either treated on-site in accordance with 105 CMR 480.150 or shipped off-site for treatment, excluding waste approved for disposal pursuant to 105 CMR 480.200(A)(1). The record-keeping log shall have secured, consecutively numbered pages and have on its cover the name of the facility, the name of the owner and operator, if applicable, and in large print the words "Medical/Biological Waste Record-keeping Log". The record-keeping log forms shall be retained for three years and shall include the information listed below. (1) The record-keeping log for medical or biological waste treated on-site shall specify: (a) The exact date of each treatment;(b) The quantity of waste treated;(d) The on-site treatment method with documentation of applicable process parameters including, but not limited to, time, pressure, temperature, and pH;(e) The printed name and signature of the person responsible for treatment;(f) Challenge testing/quality control (QC) analytical (growth/no growth) results; and(g) The following additional information, if applicable:1. in cases where waste generators, small-scale generators or Sharps Collection Centers receive waste from an affiliated small-scale generator or a Sharps Collection Center, prior to on-site treatment:a. the exact date that the waste was received;b. the term "SSG" for small-scale generator or "SCC" for Sharps Collection Center, whichever applies; andc. the name and address of the affiliated small-scale generator or Sharps Collection Center delivering the waste.2. in cases where waste generators or small-scale generators receive sharps from a home sharps user prior to on-site treatment: a. the exact date that the home sharps were received; andb. the term "HS" for home sharps.(2) The record-keeping log for medical or biological waste shipped off-site for treatment shall specify: (a) The exact date of each shipment;(b) The total number of containers;(d) The total combined weight or volume;(e) The name of the transporter with transporter identification number (if applicable), or: 1. in cases where small-scale generators or Sharps Collection Centers conduct instate transportation of their own medical or biological waste to an affiliated generator: a. the name and address of the affiliated generator that received the waste in the transporter column; andb. the term "SSG" for small-scale generator or "SCC" for Sharps Collection Center, whichever applies, in the ID column.2. in cases where waste generators, small-scale generators or Sharps Collection Centers receive waste from an affiliated small-scale generator or a Sharps Collection Center, prior to shipment off-site for treatment: a. e name and address of the affiliated small-scale generator or Sharps Collection Center delivering the waste in the transporter column; andb. e term "SSG" for small-scale generator or "SCC" for Sharps Collection Center, whichever applies, in the ID column.3. cases where waste generators or small-scale generators receive sharps from home sharps users prior to shipment off-site for treatment, the term "HS" in the ID column.(f) The verification (via check box) of shipping papers generated with receipt of corresponding medical waste tracking forms for each shipment; and(g) The printed name and signature of the person responsible for shipping the waste.(C) Develop, maintain and incorporate into the record-keeping log a written contingency plan for spills and accidents and have available tools and materials sufficient to implement the contingency plan in case of a spill or accident.(D) Retain results of annual calibration procedures for parametric monitoring equipment with the record-keeping log for three years, if applicable.(E) Retain results of all analytical Q.C. test results with the required record-keeping log for three years.(F) Retain with the required record-keeping log, a copy of all applicable registrations and material safety data sheets (MSDS) for chemicals used in approved disinfection methods pursuant to 105 CMR 480.150.(G) Retain with the required record-keeping log, a list of all IBC members, past and present, with credentials, minutes of all IBC meetings and recommendations of the IBC pursuant to 105 CMR 480.200(F)(3) and 105 CMR 480.200(F)(5).(H) Retain with the required record-keeping log, copies of all shipping papers with corresponding medical waste tracking forms, or the signed original shipping papers in the case of small-scale generators or Sharps Collection Centers that transport their own waste within the Commonwealth pursuant 105 CMR 480.400(D), for a period of 375 days.(I) Make all such procedures, records and record-keeping log accessible and available upon request to the Department and the Board of Health at all reasonable times.