2019 Rule Revision

The NC Rules Review Commission approved the revised the 2H .0800 rules on June 20, 2019 and became effective on July 1, 2019. Although most of the revisions should have little impact since they have codified the policies laboratories already have in place, we understand that it takes time to fully digest any changes and then implement them; so the following implementation deadlines have been set.

Fees

The updated fee schedule in the Rule affects all laboratory types and has been implemented immediately. See the new fee schedule for Field and Non-field Laboratories on the linked pages.

Non-Field Laboratories

Most amendments that affect Non-field Laboratories codify policies that Certification was already requiring. As such, the implementation date for any applicable changes in the rules will be January 1, 2020. 

Some of the new requirements that may need to be implemented or that may impact your laboratory follow:

  • The following parameters have been defined as Field Parameters:  Total Residual Chlorine, Free Available Chlorine, Conductivity, Dissolved Oxygen, pH, Settleable Residue, Salinity, Sulfite, Turbidity, Temperature, Vector Attraction Reduction Option 5, Vector Attraction Reduction Option 6, and Vector Attraction Reduction Option 12.
  • Explosives was added to the list of certifiable parameters.
  • Acetonitrile/Acrolein and Acrylonitrile are two separate parameters now.
  • Total Hardness has been added to the metals category.
  • Vector Attraction Reduction Options 9, 10, and 11 are separate parameters.
  • Flashpoint and Ignitability are separate parameters.
  • To afford more flexibility, the rule states that supervisors must only contact (not visit) the laboratory each day. It also extends the length of time that substitute supervisor can remain in charge in the supervisor’s absence to 12 weeks to align with the Family and Medical Leave Act (FMLA).
  • The analysis frequency of a standard for residue parameters (excluding Settleable Residue) was increased from quarterly to monthly.
  • The rule requires reviewing Standard Operating Procedures and other QA/QC documentation every two years.
  • The rule reduces the decertification period for consecutive Unacceptable PT Results from 60 to 30 days. The rule also requires that if recertification is not requested within 2 years of the decertification effective date, adding the subject Parameter Method will be treated as an initial Certification for that Parameter Method.

For the documented training program requirement, current analysts may be grandfathered in by signing statements attesting that:

  1. staff have the education, training, experience, or demonstrated skills needed to generate quality control results within method-specified limits and meet the requirements of these Rules;
  2. staff have read the laboratory Quality Assurance Manual and applicable Standard Operating Procedures; and
  3. staff have obtained acceptable results on Proficiency Testing Samples pursuant to Rule .0803(1) of this Section or other demonstrations of proficiency (e.g., side-by-side comparison with a trained analyst, acceptable results on a single-blind performance evaluation sample, an initial demonstration of capability study prescribed by the reference method).

Field Laboratories

15A NCAC 02H .0805 (g)(4) requires Field Labs to have Standard Operating Procedures (SOPs). The deadline for this will be July 1, 2020.

15A NCAC 02H .0805 (g)(5) requires Field Labs to develop and implement a documented training program. The deadline for this will be August 1, 2020.

We understand that it takes time to develop SOPs and since part of the documented training program requirements are to attest that staff have read the laboratory Quality Assurance Manual or applicable Standard Operating Procedures, you must have those SOPs in place before you can do that. We hope to help with this process by providing SOP templates for the Field Parameters by mid-August. These will be posted on our website and we will send out a notification when they are available.

For the documented training program requirement, current analysts may be grandfathered in by signing statements attesting that:

  1. staff have the education, training, experience, or demonstrated skills needed to generate quality control results within method-specified limits and meet the requirements of these Rules;
  2. staff have read the Standard Operating Procedures; and
  3. staff have obtained acceptable results on Proficiency Testing Samples pursuant to Rule .0803(1) of this Section or other demonstrations of proficiency (e.g., side-by-side comparison with a trained analyst, acceptable results on a single-blind performance evaluation sample, an initial demonstration of capability study prescribed by the reference method).
Any revisions not associated with those two rules have an implementation date of January 1, 2020.

 

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