1. EVOLVING ASPECTS OF QUALITY ASSURANCE IN LABORATORY TESTING Patrick St.Louis, PhD, Dip Clin Chem Sainte-Justine Hospital Montreal, Canada Congress SCPC, 2004

2. Quality  the total characteristics of a process or procedure that affect its ability to satisfy its intended application To appreciate the need for quality we must understand the impact of poor quality automobile: safety/accidents, repairs - time and cost cigar: taste, low satisfaction, poor reputation - sales laboratory test result: inappropriate treatment delays in treatment direct harm - repeat punctures social and economic harm

3. Quality Assurance (QA)  the systematic activities needed to ensure that the requirements of quality will be met. An efective laboratory QA program will provide reliable test results with a minimum of delay and the efficient use of resources, taking care to address patient safety and to minimise laboratory errors.

4.  Select processes and identify steps for improvement  Need objectives with measurable quality indicators; objectives should have clinical, patient care relevance.  For example: “To reduce the number of unlabelled specimens received”  measurable  patient care relevance:  number of repeat sticks  time delay to results and treatment

5. The laboratory QA program must consider all phases of the laboratory testing process and the steps that can benefit from quality improvement pre-analytical, analytical and post-analytical

6. Pre-analytical phase  patient identification  specimen: collection, identification  laboratory: reception and verification  pre-test handling: separation decanting aliquotting ( labelling )

7. Patient identification: (CRITICAL) §Armbands “No specimen shall be drawn from a patient who is not wearing an armband” §Double identification: name (ask), number §Special situations: newborns, patients in the ER §Sample identification: care should be taken to correctly identify the specimen at this time.

8. Specimen  collection: proper procedure; repeat punctures; correct samples - no omissions; needlestick injuries  identification: label must be affixed  transport: delays ( time-stamping, tube systems )  inappropriate and un-protected samples  Sample volume issues

9. Pre-analytical phase  patient identification  specimen: collection, identification  laboratory: reception and verification  data/order entry  pre-test handling: separation decanting aliquotting ( labelling )  delay or loss in laboratory ( this occurs more often than we would like )

10. Studies on laboratory errors  pre-analytical errors  30%-75% of total errors  patient/specimen ID errors  34 - 58% of pre- analalytical errors Bonini et al. Clin Chem 2002; 48:691-698 Astion et al. Am J Clin Pathol 2003; 120:18-26 CAP-Q Probes study Order entry errors can be as high as 5% of tests entered; most frequent  test request not entered Valenstein & Meier, Arch Pathol Lab Med 1999; 123:1145-1150

11. Analytical phase  need well-written protocols (methods; format)  ensure reliability of test (NCCLS, ISO): establish or verify linearity verify limits of detection and analytical range evaluate precision and accuracy establish institution-specific reference ranges  reagent handling: storage, expiry dates; fridge temperatures  instrument breakdown and repair logs: down time causes loss of effective working time and delays in results

12. Quality control (QC)  operational techniques and activities that are used to fulfill requirements for quality QC for the analytical phase : traditional automatic electronic Continuous system monitoring: total system; remote sensing and monitoring

13.  use of split samples and other means of internal assessment and monitoring  concordance between analysers  External QC programs (proficiency testing) External QC results and proficiency testing material as tests of trueness

14. Post-analytical phase § Result validation: automatic, absurd results (contamination by IV fluids, saline, glucose,) § Reflex testing eg TSH and T3, T4 § Reports and interpretations ( HbS, tumor markers ) § Managing critical and unusual results: l protocols defining critical values and actions l calls and read backs § Problems inherent in manual entry of results § Sample storage and retrieval for supplementary testing; a good system saves time

15. §The total QA process can benefit from the laboratory information system (LIS):  time stamps  identity tags  traceability from specimen collection to test result  previous results and delta checks  format of laboratory reports; reference values and comments

16. Approach to QA program é Develop protocols and policies é Identify intervention points é Use Risk Reports: laboratory and/or hospital; government mandated reporting é Prepare regular QA reports; ensure distribution and follow up.

17. Preparation of QA reports and follow up é statistical analysis: by period, by clinical unit é explain/understand the consequences of particular problems and the reason for actions: eg improper sample identification leading to sample rejection or certification; real or potential harm to the patient é avoid blame and seek support é interdisciplinary problems

18. Some policies at HSJ  patient identification  specimen identification and certification  specimens delayed in transport (use of pneumatic tube system)  adequate filling of specimen tubes (anti- coagulation)  instrument maintenance, breakdown and repair log sheets  temperature logs for refrigerators and freezers  critical values protocols: values and actions

19. Specimen ID errors: HSJ protocol  rejection é Specimen not identified/labelled é no requisition é identification errors: wrong patient, wrong label on specimen, wrong requisition, sample and requisition do not match Are all mis-labelled samples rejected? Some samples are hard to replace é Certification by someone responsible on the clinical side

20. HSJ 2003/2004: from “Certification Forms” l 132 sample-related incidents 64 - no identification 36 - wrong identification number of rejections = 90 number of certifications and acceptances = 8 We have noted a marked decrease in the number of events; under-reporting of problem cases ? What about when the test is already done and the report sent; removing results from the patient chart; do not transfer results

21. §Responsibility for QA: Everyone An institutional issue, having administrative support Uses analytical and statistical tools §Two aspects identify and resolve any current problems long range anticipation to improve processes

22. Publications: NCCLS documents ISO 15189: Standards for Medical Laboratories Relating to Quality and Competence