N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.8

Current through Register Vol. 46, No. 45, November 2, 2024

Section 365-2.8 - Recordkeeping and reporting requirements

(a) Recordkeeping. The following records must be maintained on-site for a minimum of three years and must be available for inspection and copying by the department.

(1) A record of RMW managed by quantity and category as specified by the generator on the container and treated at the facility. Categories include cultures and stocks, human pathological waste, human blood and blood products, sharps, animal waste, and other (specify characteristics).

(2) A record of how all RMW was managed, including treatment, if applicable. For treatment, copies of certificates of treatment must be retained. For shipment off-site for treatment, copies of tracking documents must be retained.

(3) In addition, treatment facilities must:

(i) retain hard copy or electronic records of validation testing and bio-challenge testing, including protocols and test results;

(ii) retain records of parametric monitoring (e.g., the residence time, pressure and temperature of each load treated);

(iii) document each employee's participation in training and/or retraining in treatment equipment operations;

(iv) document corrective actions; and

(b) Reporting. The facility must submit an annual report covering the previous calendar year, on forms prescribed by or acceptable to the department. The report must include:

(1) a summary of the RMW managed, by quantity and if feasible, by category as specified by the generator on the containers. Categories include cultures and stocks, human pathological waste, human blood and blood products, sharps, animal waste, and other (specify characteristics);

(2) a summary of all waste received that could not be managed at the facility and how it was handled;

(3) for storage and transfer facilities, an identification of the treatment facility that received the RMW; and

(4) for treatment facilities, report any issues that have been identified (e.g., failure to attain operating requirements, equipment failures, etc.), and any corrective action taken including additional bio-challenge testing, management of spills, and special training for employees to resolve the issues.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.8

Adopted New York State Register September 20, 2017/Volume XXXIX, Issue 38, eff. 11/4/2017