OSHA Inspection: WINDSTONE MEDICAL PACKAGING

Issued

Apr 28, 2015

Abate by

May 22, 2015

Penalty

Initial $4,900 · Current $3,430 Reduced

Hazardous substances 1190

General-duty citation text

29 CFR 1910.1047(c)(1): Employees were exposed to an airborne concentration of ethylene oxide in excess of one part per million as an eight hour time-weighted average:    a) Aligned Medical Solutions: On December 12, 2014 and at times prior, an employee in the sterilization area was exposed to ethylene oxide above one part per million (ppm) as an eight hour time-weighted average during the sterilization of surgical packs.  A personal air sample was taken for 425 minutes; the remaining 55 minutes is assumed a zero exposure. The results of the samples were 1.1 ppm; approximately 1.05 times the Permissible Exposure Level of 1 ppm.     b) Aligned Medical Solutions: On December 12, 2014 and at times prior, an employee in the sterilization area was exposed to ethylene oxide above one part per million (ppm) as an eight hour time-weighted average during the sterilization of surgical packs.  A personal air sample was taken for 446 minutes; the remaining 34 minutes is assumed a zero exposure. The results of the samples were 1.8 ppm; approximately 1.8 times the Permissible Exposure Level of 1 ppm.

Issued

Apr 28, 2015

Abate by

May 22, 2015

Penalty

Initial $0 · Current $0

Hazardous substances 1190

General-duty citation text

29 CFR 1910.1047(d)(1)(ii): Representative 15-minutes short term employee exposure to ethylene oxide was not determined on the basis of one or more samples representing 15-minute exposures associated with operations that are most likely to produce exposures above the excursion limit for each shift for each job classification in each work area:  a) Aligned Medical Solutions: On December 12, 2014 and at times prior, employees were exposed to unknown levels of ethylene oxide during the operation of the SteriJet, change out of the ethylene oxide tank, and removal of packs from the cells because the employer did not conduct short term exposure monitoring.

Issued

Apr 28, 2015

Abate by

May 22, 2015

Penalty

Initial $0 · Current $0

Hazardous substances 1190

General-duty citation text

29 CFR 1910.1047(f)(1)(i): Feasible engineering controls and work practices were not adequate to reduce and maintain employee exposure to ethylene oxide to or below the time weighted average:  a) Aligned Medical Solutions: On December 12, 2014 and at times prior, employees were exposed to ethylene oxide above the PEL during the operation of the SteriJet without adequate engineering controls and work practices being established to reduce the employee exposure.  An employee in the sterilization area was exposed to ethylene oxide above one part per million (ppm) as an eight hour time-weighted average during the sterilization of surgical packs.  A personal air sample was taken for 425 minutes; the remaining 55 minutes is assumed a zero exposure. The results of the samples were 1.1 ppm; approximately 1.05 times the Permissible Exposure Level of 1 ppm.   b) Aligned Medical Solutions: On December 12, 2014 and at times prior, employees were exposed to ethylene oxide above the PEL during the operation of the SteriJet without adequate engineering controls and work practices being established to reduce the employee exposure.  An employee in the sterilization area was exposed to ethylene oxide above one part per million (ppm) as an eight hour time-weighted average during the sterilization of surgical packs.  A personal air sample was taken for 446 minutes; the remaining 34 minutes is assumed a zero exposure. The results of the samples were 1.8 ppm; approximately 1.8 times the Permissible Exposure Level of 1 ppm.

Issued

Apr 28, 2015

Abate by

May 22, 2015

Penalty

Initial $0 · Current $0

Hazardous substances 1190

General-duty citation text

29 CFR 1910.1047(f)(2)(i): Where the time-weighted average (TWA) for ethylene oxide was exceeded, a written program had not been established and implemented to reduce employee exposure to or below the TWA and/or to or below the excursion limit by means of engineering and work practice controls and by the use of respiratory protection where required or permitted under 29 CFR 1910.1047:  a) Aligned Medical Solutions: On December 12, 2014 and at times prior, employees were exposed to ethylene oxide above the PEL during the operation of the SteriJet without a compliance program established to reduce the employee exposure.  An employee in the sterilization area was exposed to ethylene oxide above one part per million (ppm) as an eight hour time-weighted average during the sterilization of surgical packs.  A personal air sample was taken for 425 minutes; the remaining 55 minutes is assumed a zero exposure. The results of the samples were 1.1 ppm; approximately 1.05 times the Permissible Exposure Level of 1 ppm.   b) Aligned Medical Solutions: On December 12, 2014 and at times prior, employees were exposed to ethylene oxide above the PEL during the operation of the SteriJet without a compliance program established to reduce the employee exposure.  An employee in the sterilization area was exposed to ethylene oxide above one part per million (ppm) as an eight hour time-weighted average during the sterilization of surgical packs.  A personal air sample was taken for 446 minutes; the remaining 34 minutes is assumed a zero exposure. The results of the samples were 1.8 ppm; approximately 1.8 times the Permissible Exposure Level of 1 ppm

Issued

Apr 28, 2015

Abate by

May 22, 2015

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.1047(d)(7)(i): The employer must, within 15 working days after the receipt of the results of any monitoring performed under this section, notify each affected employee of these results either individually in writing or by posting the results in an appropriate location that is accessible to employees:  a) Aligned Medical Solutions: On December 12, 2014 and at times prior, employer did not communicate the results of the ethylene oxide personal air sampling that was performed.

Issued

Apr 28, 2015

Abate by

May 22, 2015

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.1047(k)(2)(i): An accurate record of all measurements taken to monitor employee exposure to ethylene oxide Et0 was not kept as prescribed in 29 CFR 1910.1047(d):  a) Aligned Medical Solutions: On December 12, 2014 and at times prior, employer did not have accurate records of employee exposure to ethylene oxide.  Information regarding the operation sampled, the full name of the employee sampled, Social Security Number of employee sampled, and the exposure of employees that the sample represents was not documented.