NALMA / Laboratory Advisory Committee Meeting June 19, 2003 Laboratory QC Paul Sauvé, CLS QC Forms, Excel Templates QC U

1. NALMA / Laboratory Advisory Committee Meeting June 19, 2003 Laboratory QC Paul Sauvé, CLS QC Forms, Excel Templates QC Update, Problems and Improvements

2. Quality Control: • Planned activities designed to provide a quality product. • Start-up routines • Control samples • Maintenance programs • Quality Assurance: • Planned activities designed to ensure that the quality control activities are being properly implemented. • Management review • Laboratory audit • Certification • Operating procedures, training procedures

3. Quality Control, Primary Objectives: • Deliver real-time feedback on the quality and reliability of test results being generated. • Maintain a comprehensive record of critical laboratory information. • A good QC system will satisfy BOTH of these objectives effectively and efficiently. • Many of the existing systems only completely address one of these objectives.

4. Deliver real-time feedback on the quality and reliability of test results being generated. • Start-up checks • Control samples • Zero checks • The feedback to the analyst must be immediate. Testing should not continue if QC tolerances are not satisfied. • Frequently we see that critical calculations are not being done until AFTER samples have been analyzed. • Poorly designed automated systems will allow for collection of QC data without appropriate review or response to nonconformances.

5. SCC Repeatability:

6. Maintain a comprehensive record of critical laboratory information. • Why? • To help when troubleshooting equipment problems; • To help when troubleshooting staff problems; • To demonstrate competence in the event of a challenge.

7. Traceability: • Quality Control Procedures • Lab • Analyzer • Date • Time (if appropriate) • Operator • Results • Tolerances • Status (pass or fail)

8. Routine Test Data • Date of collection • Collected by: • Date of receipt in lab • Date of analysis • Sample condition • Analyzers used • Operator(s) • Traceability: • Quality Control Procedures • Lab • Analyzer • Date • Time (if appropriate) • Operator • Results • Tolerances • Status (pass or fail) • Follow-up

9. Instrument Maintenance: Most labs do a great job of maintaining their instruments and a horrible job of keeping maintenance schedules and records. Schedules of routine procedures should be developed and documented. Comprehensive records should be maintained. The auditor will recommend that the CDCB guidelines be modified to put more emphasis on this issue. Recommendation: If the auditor cannot determine that analytical instruments have been appropriately maintained, those instruments must not be used for official testing.

10. Maintenance records should include: • Instrument; • Date; • Identity of the staff member or Service Technician; • Reason for service; • Routine scheduled maintenance; • Instrument malfunction; • Failure of a QC check; • Sample count (if available); • Parts repaired or replaced; • QC checks (including results) done prior to returning the analyzer to service; • Identity of any test results which may be invalid as a result of the problem.

11. Many of the existing QC systems are too complicated. • Some labs have a separate form for each daily activity: • Sample logs and barn sheets • Sample condition reports • IR start-up zeros • IR repeatability check • IR hourly zero checks • IR control sample checks • SCC start-up zeros • SCC repeatability check • SCC control sample checks • etc.

12. Some labs have implemented multiple QC systems to satisfy the various certification agencies. • Some labs have added new or revised QC procedures over the years without deleting those which are obsolete. In once case, staff were doing the repeatability check for cell counters twice because one standard specified six replicates and the other specified ten. • The CDCB guidelines can be appropriately addressed with four well designed templates: • Equipment maintenance log; • Precalibration check; • Calibration checks and adjustments;

13. Are computerized procedures and records acceptable? • YES • If QC procedures are automated, the following conditions must be satisfied: • Real-time checks must be done. It is not acceptable to collect the results and key the data into a spreadsheet at a later time. • Failures must be identified immediately and operators must be required to respond. If tolerances are satisfied, there is no need for operator intervention (zeros, controls).

14. Continual Improvement: Some labs have passed their QC evaluation several years in a row without addressing any of the issues identified in the audit report. The auditor will recommend that the CDCB guidelines be modified to put more emphasis on continual improvement. Recommendation: QC procedures should be modified to address deficiencies identified in the audit report.

15. Continual Improvement: To help Managers correct deficiencies, simple checklists are now being provided along with each audit report. • Conformance checklist for items identified during the on-site assessment of: • XYZ DHIA, January 15, 2003 • Tolerances for MD and SDD should be added to the calibration records. • IR zeros should only be reset if drift tolerances are exceeded. • IR drift values should be recorded PRIOR to resetting the zero. • Maintenance records should identify the Service Technician. • All QC records should identify the operator and the line number. • ***************************************************************** • 10 of the 13 deficiencies identified at the previous audit (January 17, 2001) have been appropriately addressed. An additional two items have been identified in this report.

16. Sample Unknowns: Results are generally good. Most labs are meeting the reporting deadline and performing well. We are identifying and correcting about three data entry errors each month. If the data entry screens are used properly this cannot happen. Some labs are still not treating the unknowns like normal test samples. Some are reporting averages of multiple test results or multiple instruments. Others are reporting IDENTICAL values for all duplicate analyses. If you think you have a bad sample, report it anyway. We’ll identify it during the data analysis. If you are really worried, send an email. DON’T leave it blank or report the duplicate value. This makes it more difficult to identify problems. We take about 12 calls a month asking if labs are “IN” or “OUT”. Nonconformances are not assessed on a single trial. Read the guidelines.