SubPart 70-4 - Requirements for Alternative Regulated Medical Waste Treatment Systems

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-4.1 - Approval of technology

70-4.1 Approval of technology. (a) No alternative treatment system shall be used to treat regulated medical waste without approval by the Commissioner of Health of the treatment technology pursuant to Subpart 70-5 of this Part. In the approval of an alternative treatment technology, the Department shall specify the scope of the approval, including, but not limited to, the type(s) of waste and/or waste composition for which the system has been approved.

(b) No regulated medical waste other than that of a type and composition specified in the Commissioner of Health’s approval of an alternative treatment technology shall be treated using the approved technology.

(c) No facility shall use an alterative treatment system to render harmless, dispose of or otherwise handle, in the same or different loads than regulated medical waste, material other than the regulated medical waste for which the system received approval, unless the facility, jointly with the system manufacturer, demonstrates to the Department that the system is effective in treating regulated medical waste and that the system is not impacted adversely by the facility’s use of the system for purposes other than treating regulated medical waste.

(d) An autoclave used to treat human tissue(s), human and animal organs, and/or animal body parts shall require approval as an alternative treatment system pursuant to Subpart 70-5 of this Part. An autoclave operated at a residence time, temperature and/or pressure other than those prescribed in section 70-3 shall require approval as an alternative treatment system pursuant to Subpart 70-5 of this Part.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-4.2 - Operational Requirements

70-4.2 Operational requirements. (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 sixty (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 Subpart, 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.

(d) Any modification of an approved operation plan altering treatment efficacy shall be submitted to the Department for approval prior to implementation. Prior to approving a modified plan, the Department may require efficacy and/or validation testing, using a protocol approved pursuant to section 70-4.3 (b) of this Subpart. The Department may require the submission of additional information and data specific to the alternative treatment system as may be pertinent to a demonstration of on-going safety and efficacy.

(e) No alternative regulated medical waste treatment system shall be placed into operation prior to implementation of an approved operation plan.

(f) An alternative regulated medical waste treatment system shall be operated in accordance with the system manufacturer’s instructions and the approved operation plan. Should a system fail during operation, the operating facility shall:

(1) discontinue use of the system, using emergency shutdown procedures if appropriate, until corrective action is taken and verified through parametric controls; validation testing, including but not limited to, biological indicators; or other demonstration that treatment has been attained;

(2) handle as untreated all regulated medical waste processed by the system since the last previous run under documented compliance with such requirements;

(3) document the failure, including date and system identifier;

(4) document the facility response, including corrective action;

(5) whenever a facility has reason to believe untreated waste certified as treated waste has left the facility; notify the waste transporter immediately upon discovery of the incident, at least within a maximum of two business days and notify the Department within seventy-two (72) hours of the waste’s leaving the facility.

(g) For systems that employ parametric controls for automatic and continuous monitoring, the facility shall generate a record of monitoring that identifies operating parameters throughout the cycle. In the absence of such controls, the operational performance of an alternative regulated medical waste system shall be monitored by challenge testing pursuant to a protocol included in the facility’s operation plan and approved by the Department.

(h) No person shall load, operate and/or unload an alternative regulated medical waste treatment system without documented training and retraining in the activities performed. Documentation shall include the date, location and content of all training sessions, as well as an attestation, by signature of trainer and trainee, that such training or retraining was conducted.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-4.3 - Validation testing

70-4.3 Validation testing.

(a) A facility seeking to operate a regulated medical waste treatment system that employs an approved alternative technology shall establish and implement a protocol for validation testing that minimally includes procedures to simulate actual system operation conditions, including, but not limited to, the composition and volume of waste to be treated per load. The validation testing protocol shall be approved by the Department prior to initiation of testing.

(b) Validation testing shall be performed using the Department-approved protocol at the installation site of an approved alternative regulated medical waste treatment system.

Validation testing data shall be submitted for Department review and approval along with the operation plan.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-4.4 - Record keeping

70-4.4 Record keeping.

(a) Each facility shall document efficacy and validation testing, including testing protocols and results, and routine system monitoring, and shall retain such records for three (3) years.

(b) Each facility shall document, in the personnel file of each employee, participation in system training and/or retraining, and retain such records for three (3) years.

(c) Documentation of corrective action, including that required by section 70-4.2 of this Subpart, shall be retained for three (3) years.

(d) Each facility shall document any modification to an approved operation plan and retain such records for three (3) years from discontinuance of the modified plan.

(e) The facility in which the alternative treatment system is situated shall maintain a copy of the Department’s letter notifying the manufacturer of the alternative treatment technology approval and any appendices or amendments thereto for as long as the system is operational.

(f) All records required pursuant to this section shall be made available for inspection and copying by the Department.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete