Quality Systems: Cryptosporidium and Giardia Analyses Program
The Cryptosporidium and Giardia Analyses Program is collectively managed by the State Hygienic Laboratory’s leadership team using ISO 17025 compliant quality procedures from sample receipt through final reporting. All sections of the laboratory follow standardized procedures.
In Central Accessioning, all samples are evaluated for satisfactory acceptance (e.g. temperature and holding times), logged into the Laboratory’s LIMS system called Open ELIS, labeled with a unique laboratory number, and then transported to the laboratory. In Client Services, meta-data is entered into Open ELIS and verified.
In the Environmental Microbiology section, samples are again double-checked for acceptance and correct lab number labeling before processing begins. Ongoing precision recovery and method blank samples are processed as required and read prior to sample processing to make sure all systems are in control. This QA data is charted and all staff are aware of the laboratory’s control limits. If not within these limits, root-cause analysis is performed, corrective action is instigated, the supervisor is notified, and controls are repeated. Samples are processed within all holding times which are prominently listed on the worksheet.
Analyst verification is performed monthly, and IMS positive controls are performed and charted. All math calculations are double-checked by another analyst. John Kempf, lead analyst for this method, is responsible for facility calendars and sampling questions for round one and will fulfill this role for round two.
The Environmental Microbiology Manager (or her delegate) reviews all data packages which include cyst/oocyst photographs, reviews all QC charting for control and trends, and releases the record in Open ELIS. The final report is generated twice daily, and clients with web access are notified that their results are available online.
Central Services personnel manage kit preparation and shipment. Accounts Receivable staff send out invoices monthly. SHL’s QA officer, Mr. Jeff Wasson, is in charge of Method 1623.1 certification requirements with ORELAP personnel, management reviews, laboratory assessment for non-compliance issues and customer complaints, and document control in iPassport.