Loading...
HomeMy WebLinkAbout#610-followup-final INSPECTION REPORT ROUTING SHEET To be attached to all inspection reports in-house only. Laboratory Cert. #: 610 Laboratory Name: Environment 1, Inc. Satellite Laboratory Inspection Type: Commercial Maintenance Inspector Name(s): Todd Crawford and Gary Francies Inspection Date: December 14, 2010 Date Report Completed: December 16, 2010 Date Forwarded to Reviewer: December 16, 2010 Reviewed by: Jason Smith Date Review Completed: December 16, 2010 Cover Letter to use: Insp. Initial X Insp. Reg. Insp. No Finding Insp. CP Unit Supervisor: Dana Satterwite Date Received: December 17, 2010 Date Forwarded to Alberta: January 3, 2011 Date Mailed: January 3, 2011 _____________________________________________________________________ On-Site Inspection Report LABORATORY NAME: Environment 1, Inc. Satellite Laboratory ADDRESS: P.O. Box 7085 Greenville, NC 27835 CERTIFICATE #: 610 DATE OF INSPECTION: December 14, 2010 TYPE OF INSPECTION: Commercial Maintenance AUDITOR(S): Todd Crawford and Gary Francies LOCAL PERSON(S) CONTACTED: Mark Oliveira and Chad Davis I. INTRODUCTION: This laboratory was inspected to verify its compliance with the requirements of 15A NCAC 2H .0800 for the analysis of environmental samples. II. GENERAL COMMENTS: This inspection was a follow-up to the inspection that occurred on July 29, 2010 to assess the changes made to fecal coliform analysis. Sample setup and analysis has been moved from a van to a hotel room. The air incubator has been replaced with a water bath. All other aspects of sampling and analysis have essentially remained the same. Prior to these changes, split sample results between the satellite lab and the Environment 1, Inc. main lab in Greenville, NC showed low counts for the results obtained in the van setting. Since these changes, split sample results have become more statistically comparable with those obtained at the main lab. This audit consisted of an inspection of the hotel room setup and observations of the analysis of several samples that were collected that morning, and the reading of samples that were analyzed the day before. All findings and recommendations from the previous report, dated September 10, 2010, appear to have been corrected and implemented. Carrie Ruhlman, Monitoring Coalition Coordinator with ESS, and Carol Bell with the Yadkin/Pee Dee River Basin Association were also on hand to observe. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Coliform, Fecal (MF) – Standard Methods, 18th Edition, 9222 D Comment: After sample filtration, plates were allowed to sit on the bench for up to 30 minutes before being placed in the water bath. This is the maximum amount of time allowed according to the method. The analyst stated that this was to help maintain the proper water bath temperature by minimizing the number of times that the water bath lid was opened. Special attention needs to be paid to ensure that the 30 minute time requirement is met. Page 2 #610 Environment 1 Inc., Satellite Laboratory A. Finding: The temperature inside the refrigerator where the media is being stored is not being monitored or documented. Requirement: Each day an incubator, oven, waterbath or refrigerator is used, the temperature must be checked, recorded, and initialed. Ref: 15A NCAC 2H .0805 (a) (J). Requirement: Store finished medium at 4 to 8ºC, preferably in sealed plastic bags or other containers to reduce moisture loss, and discard unused broth after 96 hours or unused agar after 2 weeks. Ref: Standard Methods, 18th Edition, 9222 D. (1) (a). Recommendation: Document refrigerator temperature on the same sheet with the water bath temperature. Documentation Recommendation: Change the wording of the space on the benchsheet where the time that samples are put into the water bath is documented from “Analysis End Time” to “Time into the Incubator”, or something similar that better reflects what the time actually is. This will mo re clearly satisfy the requirement to document the time that samples are put in the incubator. IV. PAPER TRAIL INVESTIGATION: No paper trail performed. V. CONCLUSIONS: Correcting the above-cited findings and implementing the recommendations will help this lab to produce quality data and meet certification requirements. The inspectors would like to thank the staff for its assistance during the inspection and data review process. Please respond to all findings. Report prepared by: Todd Crawford Date: December 16, 2010 Report reviewed by: Jason Smith Date: December 16, 2010