October 25, 2016
Matt Zetterman
Laboratory Director
Kennebec Water District
P.O. Box 356
Waterville, ME 04903
Subject:2ndFollow-Up Report.
Dear Mr. Zetterman:
We have read your responses, received onOctober 12, 2016, to the On-Site Assessment Report of your laboratory. Your responses are acceptable to the Maine Laboratory Certification Program with the following exceptions for which we request further clarification. The original deficiency, your response to that deficiency, the original new / further inquiry, your response and our second further inquiry is listed (in purple). The instructions for responding to this report can be found at the end of the report.
During the on-site assessment, I went through a list of corrections/edits that should be made to the QAM. I’m not seeing the changes that we discussed. For example:
1. Table 3.3.1 still lists Total P with a 30-day hold time. This should have been changed to 28 days.
2. Section 4.9.1.1 still states, “Work in Progress Unconstruction as of 7/28/10”.
3. The 4th Ed. of MCLADW should now be the 5th Ed.
Please go back to the QAM printout used during the assessment to correct all of the errors/changes/improvements that we discussed.
Please see attached QAM. According to my notes all of the changes we’ve discussed should now be included.
Additional corrections to the QAP are needed. Please see notes on the attached copy of the QAP.
The QAP has been corrected with the changes as suggested. In regards to the appendices we have them as separate documents electronically because some of those documents need to be printed more regularly than others so it makes them more accessible. We could include them in both the QAP and separate documents but I’m afraid they’ll get updated in one place and not the other and we’ll have multiple versions floating around. In the copy that is printed off in our lab binder the appendices are included in the QAP. I’ve included them as separate documents for your reference. If this method is not acceptable we will make the change.
JJ/CB6. Quality Systems. Distilled water, deionized water, or reverse-osmosis produced water that is free from bactericidal and inhibitory substances must be used in the preparation of media, solutions, and buffers. The quality of the water must meet the requirements as listed in Section 11 (E)(2) (Maine Rules Section 18 H 3). No water quality records for water used in preparation of check sample.
Response:
We will be performing and documenting testing as required by the state lab rules. We have ordered a quantity of distilled water that should last us at least a year. That shipment of water includes a certificate of analysis that includes heavy metals. We will be performing as many of the remaining tests we can in-house and will work with the Health and Environmental Testing Laboratory to test for anything we’re not able to test for ourselves. These parameters are as follows:
Test / Monitoring Frequency / Maximum Acceptable LimitConductivity / Continuously or
with each use / >0.5 megohms resistance or
<2 umhos/cm at 25oC
pH / With each use / 5.5-7.5 S.U.
Total organic carbon / Monthly / <1.0 mg/L
Heavy metals, single
(Cd, Cr, Cu, Ni, Pb, and Zn) / Annually * / <0.05 mg/L
Heavy metals, total / Annually * / <0.10 mg/L
Ammonia/organic nitrogen / Monthly / <0.10 mg/L
Total chlorine residual / Monthly or
with each use / <0.01 mg/L
Heterotrophic plate count / Monthly / <1,000 CFU/mL
Further inquiry: Has the lab received the shipment of water? Have the necessary tests been completed? Please provide documentation.
Response:
We have received a 5 gallon quantity of distilled water which should last us a while. The certificate of analysis we received didn’t contain the information we expected to receive so we are in the process of getting all of the water quality parameters analyzed. We are able to do conductivity, pH, total chlorine residual, and HPC in-house so those have been completed. We have received results for ammonia/organic nitrogen, and are just waiting to get our results back for heavy metals.
The maximum acceptance limits for the organic nitrogen is incorrect on the water testing form. It is written as <1.0 mg/L when the actual acceptable limit is <0.10 mg/L, as indicated in the table above. The water testing form also indicates that the concentration is equal to 0.1 mg/L (which would fail), but the laboratory results indicate that it is <0.1 mg/L. Please correct the water testing form to reflect correct acceptance limits and analysis result.
Please see the corrections below as well as the test results for heavy metals.
JJ/CB17. Quality Systems. The laboratory management must ensure that the training of the laboratory personnel is kept up to date (on-going) by…documentation that the employee has read, understands and uses the latest version of the laboratory’s quality documents (Maine Rules Section 16 D 4 a). Management needs to ensure each employee reads and understands laboratory documents, including the QA Manuals, SOPs, original methods, etc.
Response:
We will perform a review and document by August 31, 2016.
Further inquiry: Has the management completed the review of these documents? Please provide documentation.
Response:
The review of these documents has been completed, please see sign-off sheet below:
While documentation of training and review of laboratory documents has been recorded, Lab Cert. requires that the documentation include the language “the employee has read, understands and uses the latest version of the laboratory’s quality documents”as part of that documentation(Maine Rules Section 16 D 4 a). We recommend adding this language to the sign-off sheets and where noted in the QAM. The documents should also have a signature line to indicate who approved the document for use.
Please see revised form below:
JJ/CB18. Quality System. A laboratory must have a written sample acceptance policy that clearly outlines the circumstances under which samples will be accepted or rejected by the laboratory. Data from samples that do not meet the laboratory's criteria must be recorded in an unambiguous manner clearly defining the nature and substance of the deviation from acceptable procedures.
A. A laboratory's sample acceptance policy must be made available to sample collection personnel and must address, at a minimum:
(a) documentation, including sample identification; location, date, and time of collection; collector's name; preservation type; sample type; and any special remarks concerning the sample;
(b) sample labeling, to include unique identification, and a labeling system for the samples with requirements concerning the durability of the labels (water resistant) and the use of indelible ink;
(c)use of appropriate sample containers;
(d) adherence to specified holding times;
(e) adequate sample volume to perform the requested tests and relevant quality control determinations; and
(f)procedures to be used when samples show signs of damage, contamination,
inadequate preservation, or loss of integrity (Maine Rules Section 10 C 1-2).
The lab does not have a Sample Acceptance Policy.
Response:
Our existing Sample Acceptance Policy from our QAP:
“3.2.3Sample Receipt, Sample Receipt Form, and Chain-of-Custody (COC)
Samples are received in the laboratory by designated personnel and are checked immediately for analytical requests, appropriate sample container use, holding time and shipping conditions, preservation, temperature, sample identification, and chain of custody records. A Chain-of-Custody (C-O-C) form (see Appendix C for an example of a typical form) is used to document the data quality objectives for each sample; the sample conditions when obtained, during delivery, and upon arrival at the lab; and is filled out by the person sampling and delivering the sample to the lab. (“Manual for the Certification of Laboratories Analyzing Drinking Water” 4th Edition, (MCLADW) USEPA Office of Ground & Drinking Water, 1997) Drinking water compliance samples will be rejected, or reports for these samples flagged appropriately, if holding times, preservatives, or shipping conditions do not meet ME DHS requirements. If other problems are found, they are documented on the C-O-C, and the sampler is notified with specific details of the problem. “
We will be developing this policy further to be more comprehensive and detailed. Will be completed by August 31, 2016.
Further inquiry: Please send a copy of the Sample Acceptance Policy. This policy needs to be displayed at the laboratory and given to each sampler.
Response:
Please see attached Sample Acceptance Policy.
Please see the notes in the attached QAP regarding sample receipt. The language in the QAP should mirror that of the stand-alone Sample Acceptance Policy. It is recommended that language is added to the QAP.
Made changes as requested, please see attached QAP.
Note: ME DHHS instructions for responding to this report:
In order to receive / maintain accreditation, a plan of corrective action, in response to each listed deficiency / finding, with supporting documentation in hard copy and electronic format (where possible), to Maine DHHS within 30 days of receiving this report. The laboratory’s responses to this report need to be returned to Maine DHHS in Word® format. The corrective action responses listed in this report must be incorporated into the relevant laboratory Quality Assurance Manual, Standard Operating Procedure or document, where applicable. The supporting documentation may be photocopies of revised Quality Systems Manual pages, revised SOP pages, revised laboratory policies, memos, copies of analytical data, photocopies of pages from bench logbooks, revised laboratory report formats, preparation logs, packing slips, photocopies of quality control documents, new document templates, etc. It is suggested that each response should be considered a “draft” until the laboratory management receives an acceptable corrective action plan letter from Maine DHHS. At that time, the corrective actions may become an official part of the laboratory’s quality system.
Each response to a deficiency should include a clear reference to a supporting document. Each document should be numbered and correspond to the appropriate deficiency [i.e. note a “#1” on the documentation for deficiency “#1”, etc.].
If a corrective action plan involves submitting documentation by a future date, a specific laboratory established deadline needs to be included with the response.
Delays in reporting processing for responses submitted to Maine DHHS may result in suspension of laboratory certification, in total or in part (Maine Rule Section 4F5b). If the laboratory does not provide documentation of deficiency corrections or corrective actions to Maine DHHS within the required time frame (within 60 days of receiving the report of deficiencies), the certification officer will notify the laboratory that its certification is revoked in total according to Section 4J of the Maine Rules.
It will be your responsibility to meet the various objectives and deadlines stated in your corrective action plan(s). Certification may be revoked or suspended if you fail to meet those objectives and deadlines.
Report Prepared by:
Jennifer Jamison
Title: Laboratory Certification Officer, Maine DHHS
Responses prepared by: Matt Zetterman
Title: Director of Water Quality/Laboratory Director Date: 11/22/2016
ME DHHSOn-Site Date: 5/17/16Page 1 of 9
Follow-Up Report: Kennebec W.D. Report Date: 9/12/16Assessor: JJ, CB