November 6, 2015

The Upper Occoquan Service Authority-Laboratory (UOSA) appreciates the opportunity to respond to the changes proposed to 1VAC30-45, Regulations Governing the Certification of Non-Commercial Environmental Laboratories.

1VAC30-45-95 C.5.  “…may allow the laboratory up to 60 days…”

We propose the removal of the 60 day limitation and propose that this is replaced with language that “allows time for the implementation of an approved corrective action plan.”

We agree with VAMWA’s proposed change.  A number of factors can influence how long it may take DCLS and the lab to work together in resolving a problem that warrants the possibility of suspension.  The flexibility in time to work together would be appreciated.

1VAC30-45-400 C.3.  “Checklists used by assessment personnel during the onsite assessment shall be provided to the laboratory with the final on site assessment report.”

We propose this statement remain in the regulation. It is beneficial for the labs to continue having access to both the checklists on the DCLS website and those marked during the onsite assessment. The checklists provided on the website and during the closing conference are a helpful tool as the laboratory works to continually improve the quality system.  We should be allowed to copy the marked checklists after the closing conference.

1VAC30-45-520 C.1.  “…corrective action documentation shall be completed in 30 days…”

It is not clear which specific documentation is required in 30 days. We propose the removal of the wording “…corrective action documentation shall be completed in 30 days…” and, instead, the addition of language that allows the laboratory time to investigate the causes: “correction action shall begin after a “not acceptable” PT study result, documented, and provided upon request by DCLS once completed.”

Expecting a laboratory to complete a corrective action on a “not acceptable” PT study within 30 days is not reasonable.  Some labs may perform non-routine tests infrequently during the calendar year and would need more time for corrective action investigations.

1VAC30-45-520 C.5. “…shall not extend the period for annual PT study completion...”

This is not clear. We propose “…shall not extend the period for makeup PT study completion...”

UOSA supports VAMWA and Spotsylvania’s request for this minor clarification.

1VAC30-45-730 D.1.  “Laboratories shall use the latest valid edition of a method unless it is not appropriate to do so.”

We propose the removal of this sentence.  Earlier in this section we are told “Laboratories shall use (i) promulgated test methods in accordance with the Code of Federal Regulations...”

UOSA supports VAMWA’s reason for this change.

1VAC30-45-730 G.  “The following certification statement shall be used to document the completion of each demonstration of capability”.

We propose “Each demonstration of capability will be documented and certified according to laboratory protocols.”

UOSA agrees with VAMWA and Spotsylvania’s proposed change.  We also agree that the certification statement should be deleted from the regulation.  Removal of the certification statement is consistent with the finalized 1VAC 30-46 regulation.