Current through Register 1531, September 27, 2024
Waste 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;
(c) The type of
waste;
(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; and
c. 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; and
b. 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;
(c) The type of
waste;
(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; and
b. 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; and
b. 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.