New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-4 - Requirements For Alternative Regulated Medical Waste Treatment Systems › Section 70-4.2 - Operational requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each
					 facility seeking to operate an alternative regulated medical waste treatment
					 system shall develop an operation plan, and shall submit such plan to the
					 department for review and approval prior to using the system to treat regulated
					 medical waste. Any change in procedures related to the operation of the system
					 shall be reflected in a modified plan, which shall be dated with each
					 revision.
(b) No alternative
					 regulated medical waste treatment system shall be used to treat regulated
					 medical waste without department approval of the facility's operation plan and
					 any modifications made to such plan on or after the effective date of this
					 regulation. The operation plan shall be submitted to the department for
					 approval at least 60 days prior to the anticipated start-up date of the
					 system.
(c) The operation plan
					 shall be designed to promote safe and effective operation of the alternative
					 treatment system. The operation plan shall include, minimally, procedures to
					 ensure:
(1) the system as situated on-site of
					 the facility meets department criteria for effective treatment of regulated
					 medical waste (i.e., the protocol for validation testing and a summary of the
					 results);
(2) loads contain only
					 those items or types of waste for which effective treatment by the system has
					 been demonstrated by efficacy testing and verified by validation testing; and
					 exclude waste materials for which effective treatment by the system has not
					 been demonstrated and/or is prohibited pursuant to section
					 70-2.3  of
					 this Part, and materials expressly excluded in the commissioner's notice of
					 approval treatment;
(3) each load
					 is treated using operating parameters that have been demonstrated as effective
					 for the treatment of regulated medical waste, and conditions of treatment are
					 monitored and documented for each load;
(4) the effectiveness of treatment is
					 maintained, by including, as applicable, procedures for and frequency of
					 calibration verification and recalibration of parametric controls; monitoring
					 by challenge testing or other demonstration that treatment has been attained;
					 and preventive maintenance of engineering controls (e.g., charcoal and/or HEPA
					 filters) and diagnostic procedures for electronic controls (e.g., integrated
					 computers and mechanical components);
(5) occupational exposure is minimized and
					 physical injury to operators is prevented during loading, the cycle, and
					 unloading of the system; and
(6)
					 personnel are knowledgeable about routine operation of the system, are kept
					 current with system manufacturer recommendations for operation, and have been
					 instructed in emergency procedures for handling malfunctioning systems and
					 untreated waste. Training programs shall mandate initial training and
					 retraining at least once per calendar year and as necessary for presenting
					 updates on operational information.