Downloaded from https://www.everyspec.com controls (personnel training and qualification, procedures, containment equipment, maintenance, and facility design) to contain IAT and to protect workers, support personnel, the environment, and laboratory products. After completing the documented (base line) risk assessment, apply risk management cyclically and to continuously identify and assess hazards that were not identified as part of the initial assessment or that evolved during the operation or activity, develop and implement controls, and evaluate outcomes.
Assess the implementation, execution, and communication of the controls, and assess accuracy of residual risk and effectiveness of controls in eliminating hazards and controlling risks. c. The SOPs are required for every biological operation using IAT in accordance with this regulation and DA Pam 385–69. The SOPs will be based on the activity’s risk assessment. The SOPs will be readily available at the work location and designated personnel will maintain a copy of SOPs in a centralized location. d.
Workers and support personnel that have been designated or granted approval of facility access during IAT operations will be identified, and their health risk assessment will be reviewed in conjunction with all occupational health examinations or screenings. 20–5. Review of biological facilities a. For new construction or major modifications of Government biological facilities, the biosafety officer and/or safety and occupational health professionals at the facility or higher headquarters will review facility design safety controls for compliance with DA Pam 385–69 and provide comments to the appropriate design review or contracting agency (for example, Health Facilities Planning Agency).
The USACE is the designer and construction agent for Army biological facilities. b. Prior to initial use, containment (BSL–3) and maximum containment (BSL–4) laboratories will be validated for safe operation through a commissioning survey. The organization conducting the commissioning survey may be in- house or contracted but will be approved by U.S. Army Public Health Command and ODASAF (see DA Pam 385–69 for commissioning survey criteria). Commissioning surveys are in addition to preoperational surveys (see below). 20–6. Facility preoperational surveys a. Prior to start of operations at new BSL–2 facilities, a preoperational survey will be completed and approved by the Army Headquarters.
The parent Army Headquarters will lead the preoperational survey. Preoperational survey teams will be composed of safety, industrial hygiene, and laboratory operations SMEs. This responsibility may be delegated to a major subordinate command. Surveys of clinical BSL–2 operations will be synchronized with the laboratory coming on line and conducted in a manner to ensure no disruptions in patient care. b.
Prior to start of operations at new biological BSL–3 and BSL–4 facilities or BSL–3 and BSL–4 facilities that have undergone major modification (defined as a modification affecting one or more commissioning certification criteria as listed in DA Pam 385–69), a preoperational survey will be completed and approved by the ODASAF. Preoperational survey teams will be led by a representative of ODASAF and composed of an industrial hygienist from USAPHC, an occupational medicine SME from the Office of the Surgeon General, and a safety and a laboratory operations SME from the appropriate Army Headquarters. The ODASAF is consulted if uncertain whether a modifica- tion requires a preoperational survey:
depending on the scale and complexity of the modification, ODASAF may delegate the survey to the Army Headquarters or major subordinate command. c. The preoperational survey will be conducted to evaluate implementation and effectiveness of the facility’s biosafety control measures and compliance with this regulation and DA Pam 385–69 to include simulation of selected operational and emergency response operations. 20–7. Containment a. Containment equipment will be used, in conjunction with personnel qualification and training and safe work practices and procedures, to minimize potential exposure of personnel and the environment to IAT. b.
Containment will be implemented to the maximum extent feasible and verified as effective. Personal protective clothing and PPE can be used in addition to primary barriers in accordance with risk assessments and the operation being performed. c. Biological protocols and SOPs will maximize use of engineering and administrative controls to preclude or minimize the need for PPE. d. The level and type of PPE required for biological activities will be based on the results of risk assessments and the criteria in DA Pam 385–69. The selection and training for use of PPE will be as specified in DA Pam 385–69. e.
Before beginning any IAT operation, a determination will be made that the hazards associated with the operation are under positive control, as defined in the applicable SOP and that the operation complies with the criteria of this regulation and DA Pam 385–69. 20–8. Special Immunization Program a. The Special Immunization Program has been established so that vaccines will be available for providing an additional level of protection to at-risk individuals involved in biological activities. The Special Immunization Program 78 AR 385–10 • 23 August 2007/RAR 4 October 2011