Jerry Lipsky Office of Standards and Quality Assurance EM-43 May 20, 2013

1. Recently Noted Quality Assurance and Operational Concerns for Respiratory Protection Devices in DOE Jerry Lipsky Office of Standards and Quality Assurance EM-43 May 20, 2013

2. Objective Identify and evaluate known respirator issues raised by workers at DOE sites. Provide information to the DOE community and others and make recommendations on a path forward.

3. Background United Steel Worker representatives voiced concerns regarding the cleanliness and residual contamination of laundered respirators provided by UniTech, a subcontracted vendor to LATA Environmental Services of Kentucky. SPRU and BWXT-Y-12 had raised similar concerns in the past A joint DOE/LATA assessment of UniTech was conducted

4. Assessment Approach Tours, interviews and process reviews were conducted at Barnwell, SC Facility. Follow up was conducted on previously raised concerns, specifically: Residual Contamination. Residual contamination was common to LATA, B&W Y-12, and SPRU. Brownish residue noted by LATA workers when conducting their own pre-use cleaning/inspections.

5. Initial Assessment Results The wash/monitor/rewash process with subsequent monitoring appears to be a reasonable approach to balance cost and risk, while providing a service that many depend on. Significant additional actions may render the process uneconomical and drive users to simply dispose of PPE. This risk needs further evaluation. The assessor noted information that led to a follow-on review for additional or complex-wide concerns.

6. Initial Assessment Results Brown residue reported by LATA workers was analyzed by MSA. Positively identified the residue as a combination of two compounds they use during production to protect rubber from degradation. Residue

7. Initial Assessment Results Residual contamination issues were addressed by UniTech Small Articles Monitor, which has a greater detection capability. SAM-12 is not an alpha detector. Additional manual survey is employed. For LATA, a 25% confirmatory sampling for beta-gamma and alpha is also conducted as a quality control measure. Other customers are provided a 10% confirmation rate. Key personnel change-out and training

8. Initial Assessment Issues • Finding-01: There is no technical basis and specification provided by the respirator manufacturer (Mine Safety Appliances [MSA]), UniTech, or LATA for the extent of respirator disassembly in order to meet cleanliness specifications for the current cleaning process. These issues are detailed in assessment report EM-PA-13-018. This report can be provided upon request.

9. Manufacturer’s Cleaning Instructions

10. Initial Assessment Issues Finding-02: The inconsistency of implementation of manufacturer’s instructions for respirator inspections, by LATA workers and UniTech staff, results in: required inspection steps not being performed; and critical respirator components being disassembled by LATA workers without the benefit of proper quality assurance and training programs.

11. Manufacturer’s Inspection Procedure

12. Initial Assessment Issues Finding-03: UniTech has no formal process to document their Quality Control Process, including sampling basis, trending, causal analysis, corrective actions and the threshold to change the sampling frequency.

13. Follow On Assessment Approach Based on concerns noted during the review at UniTech, the assessor conducted an abbreviated follow-on assessment to try to determine if other DOE sites may have similar issues or if the concerns were limited to LATA. This follow up review: was a limited procedural review of respirator cleaning and pre-use inspection processes at several DOE sites, with limited field activities.

14. Follow On Assessment Discussion An informal query was sent to other DOE sites as to what processes/protocols were followed for respirator refurbishment/cleaning, re-use, and pre-use inspection. A variety of responses were received from the sites that responded: Refurbishment/Cleaning: Some sites do all of their respirator refurbishment/cleaning on-site and some send theirs off to UniTech or other similar type vendors. Of those that send their respirators out for service, there are varying scopes of work done by both the vendor and the site.

15. Follow On Assessment Discussion Re-use of Respirators: Some sites do not re-use the respirators at all, but the majority of those informally polled do re-use respirators. Pre-use Inspection: There is also a complete range of the division of labor/responsibility for the pre-use inspections. These range from all inspections done by the site central respirator authority (with minimal pre-use inspection by the user) to the user doing extensive disassembly and re-assembly during the inspection process (as discussed above for LATA).

16. Follow On Assessment Results In general, the information reviewed indicated that the three Findings noted in the first review may have applicability at other DOE sites, especially if they use UniTech as a vendor. Two additional recommendations were provided which may have universal applicability.

17. These issues are detailed in assessment report EM-PA-13-020. This report can be provided upon request. Follow On Assessment Issues Recommendation-01: Organizations which re-use respirator cartridges should develop a technical basis demonstrating acceptable risk for the re-use of respirator cartridges, and this technical basis should be provided to relevant stakeholders for review.

18. Follow On Assessment Issues Recommendation-02: Formal expanded assessment activity should be conducted across DOE sites to ascertain the true extent of condition of inconsistency of procedural guidance for cleaning respirators, employment of manufacturer’s instructions for respirator inspections, and for flow-down of QA requirements to their respirator service vendors. This assessment should include other PPE associated with respirators such as SCBA, Hoods, supplied air, etc.

19. Conclusion Although there are some issues identified, the respirator laundering process at UniTech in Barnwell provides a reasonable approach to cleaning respirators. Each site should examine the entire process their respiratory protection equipment undergoes for refurbishment and use. Balance these processes against manufacturers’ instructions and site specific hazards and instructions, in order to ensure there is a consistent and appropriate methodology to ensure worker safety.

20. Jerry LipskyOffice of Standards and Quality AssuranceEM-43 803-952-6930 Jerold.lipsky@srs.gov

21. Background Information

22. EM-ID--ITG-AMWTF-2013-0003 PAPR Cartridge Releases Charcoal into User's Breathing Area Zone NA--LSO-LLNL-LLNL-2012-0043 Management Concern: Respirator Filter Cartridge Dislodges and Falls Off GVP Respirator Pump in Building 801A Occurrences • NA--YSO-BWXT-Y12SITE-2011-0004 • NA--YSO-BWXT-Y12SITE-2011-0011 Improper Cartridge Use NA--YSO-BWXT-Y12SITE-2012-0055 Supplied-Air Respirator Equipment Malfunction/Defect (Reconditioned Respirator) NA--LASO-LANL-TA55-2011-0021 Final Respirator Protection Factor Exceeded Resulting in Potential Overexposure to Silica NA--LSO-LLNL-LLNL-2011-0057 Worker issued respirator without required fit test in building 810B EM-SR--SRNS-KAREA-2013-0003 Failure of EVA Bullard Hood during Surveillance Activities