SPOTSYLVANIA COUNTY LABORATORY SERVICES COMMENTS ON PROPOSED REGULATIONS FOR CERTIFICATION OF NONCOMMERCIAL ENVIRONMENTAL LABORATORIES

(1VAC30-45)

November 6, 2015

GENERAL COMMENTS

1. Spotsylvania County Laboratory Services ("Spotsylvania") supports DCLS’s mission to improve the regulations for Certification of Noncommercial Environmental Laboratories with amendments to improve efficiency and support the endurance of the program.

2. Spotsylvania appreciates amendments made to the program to ensure noncommercial laboratories are not held to more demanding requirements than commercial laboratories (1VAC30-46).

3. Spotsylvania appreciates the hard work and dedication of DCLS staff. This certification program is necessary to guarantee all noncommercial laboratories are held to the same standards across the board. Spotsylvania understands this program is self-funded and hopes the new fee structure brings enough additional revenue to bring on another assessor. The one-on-one time between laboratory and assessor is incredibly important and useful.

GENERAL PROVISIONS

1. Procedures to Suspend Laboratory Certification. Spotsylvania appreciates and supports the addition of a suspension process. This step before decertification will allow laboratories time to correct deficiencies, which in the past might have resulted in automatic decertification.

2. Reduction in Number of Proficiency Tests. Spotsylvania supports the reduction of PT studies to once every year. Laboratories have been requesting this change for quite some time and Spotsylvania is pleased to see it in the proposed regulations. This change has multiple benefits for DCLS and laboratories: reduced administrative burden, cost savings for laboratories, etc. The reduced proficiency test requirement partially offsets the increased certification fees proposed by DCLS and Spotsylvania appreciates this.

3. Maintain DCLS’s On-Site Inspection Frequency Spotsylvania supports the current schedule of inspections once every two years. Spotsylvania would also consider supporting a three year inspection cycle. Spotsylvania must withhold support for VAMWA’s suggestion of a Risk Based Inspection Strategy modeled after DEQ’s model. As we understand, an inspection plan similar to DEQ’s might have low-risk laboratories inspected once every five years. Spotsylvania feels this is much too long to go without a site visit. Inspections are valuable sources of information for laboratories and provide important time for training by DCLS assessors.

4. Confirmation Related to On-Site Assessment Checklists. Spotsylvania would like to confirm that checklists completed by assessors during on-site assessments will be available to the laboratory. As we understand it, the provision for DCLS providing checklists to laboratories was removed from this regulation because the checklists are now available online. Spotsylvania would like assurance that the practice of giving laboratories completed inspection checklists is continued. These marked-on checklists are an important tool to help laboratories understand findings and troubleshoot solutions with assessors during an on-site visit.

The Augusta County Service Authority appreciates the opportunity to comment on the proposed regulations for Certification of Noncommercial Environmental Laboratories.

Specifically, we support the reduction in the number of proficiency tests required for each field of certification from twice to once per year.    As noted, noncommercial environmental laboratories perform proficiency tests quite well and this will help reduce the costs of fees for smaller utilities.

The frequency of on-site inspections should be a Risk Based approach similar to the process used by DEQ with regards to Wastewater Treatment Plant inspections.  If a facility is not having issues, then DCLS's resources could be better utilized elsewhere.  An inspection schedule of every 3 years (like Drinking Water Labs) would benefit labs and possibly allow DCLS to combine the inspections.  If a lab had specific issues, the inspection frequency could remain on a 2 year schedule.

ACSA supports the addition of procedures for temporary suspension of laboratory certification in lieu of decertification.  This gives the lab an opportunity to remedy the problem prior to its certification being withdrawn.

ACSA also supports removing references to the initial certification period and streamling the process for laboratories applying for and renewing their certifications. 

ACSA supports modifications to ensure that noncommercial laboratories are required to meet standards no more stringent than commercial laboratories.

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.