1. RT Erasmus

2. Introduction Pathology laboratories regularly inspected by various accreditation bodies such as CPA, SANAS, CAP which use ISO standards. Many of these standards based around operational delivery of laboratory analysis Few measure clinical quality such as appropriateness of service and outcome Currently some debate on the present accreditation system and calls to focus on quality outcome measures

3. Introduction(2) Found that US labs are good at incident investigations and performing patient and physician satisfaction surveys but poor at clinical guidelines, studying test utilizations and assessing test interpretations by physicians Reports suggest that lab spent more time on internal activities and not enough time on the external health care activities

4. IFCC Working Group on Lab Errors and Patient Safety (WG-LEPS) Established a series of quality indicators specifically designed for clinical labs to reduce lab errors Identified 25 quality indicators of which 20 were not related to the laboratory internal environment related to the lab –clinical interface In the US, Division of Lab Systems in CDC has established a group to examine clinical quality issues to produce best practice guidelines

5. Clinical Quality Indicators Can be classified as those relating to Preanaltyical phase Analytical phase Postanalytical

6. Identification of Clinical Indicators Many of these indicators are related to good clinical governance and point the need for labs to carry out clinical audits Whilst clinical audits have been recommended as part of the quality system, in many developing countries there is no process for carrying them out. In recognising its role in quality improvement we,in SA established a Clinical Audit Committee which is now linked to the national QA Division One of our first tasks was to write guidelines to assist laboratory personnel to carry out clinical audits

7. Abstract Audits are part of the continuous quality improvement process and one of the key elements of clinical governance. Laboratory-based clinical audits are concerned primarily with the everyday aspects of laboratory services and are a means of providing feedback to the users of the laboratory and its staff. They involve measuring the performance of laboratory services against established standards. These standards have ideally been established using the principles of evidence-based medicine. If necessary, changes are implemented and then a re-audit is performed after a certain time period to ensure that the changes have been implemented and maintained. Areas of audit in the laboratory include the preanalytical, analytical and postanalytical phases. This review article examines the basis of clinical audits in the laboratory and then proceeds to describe in detail how a laboratory-based clinical audit should be performed and monitored, with special reference to the chemical pathology laboratory. ErasmusErasmus RT, Zemlin A. Clinical audit in the laboratory. J Clin Path, 2009, 62, 593 -597 Zemlin

9. Laboratory Handbook What information does your lab provide to clinicians and other customers on Sample tubes Test menu Preanalytical variables

10. Is the test being performed on the right patient and correct tubes used ? Misidentification potentially associated with worst clinical outcome Inpatient Wristband Identification Error: Wrong info on wristbands may lead to erroneous reporting and inappropriate treatment Generally believed that identification errors are few in laboratories One study from Denmark reported that there was 1 error per 142 patients :90% were pre or postanalytical What systems does your lab have in preventing misidentification ?

11. Test order Appropriateness Does your laboratory follow specific testing guidelines such as those established by International and National Healthcare Organizations eg NICE, CDC, CAP. Found that many lab test orders are not supported by guidelines. Promotion of such guidelines, reminders, provision of education, electronic decision support systems may decrease the number of inappropriately ordered tests resulting in cost savings

12. Test ordering Is the right test being requested? What percentage of lab test orders meet specific testing guidelines : many lab test orders are not supported by guidelines What percentage of lab test orders are duplicated within defined intervals Does your lab have guidelines on repeating tests within certain time period – can have enormous cost savings

13. Patient satisfaction with phlebotomy Specimen collection is one area that involves direct patient contact – this provides an opportunity to assess pt’s satisfaction with lab services How many labs have surveyed patients about their phlebotomy services Are there patient information sheets available How many labs measure response time to 24/7 enquiries

14. Sample adequacy and Rejection Rate Specimen adequacy can affect the accuracy & usefulness of lab test results – monitoring specimen acceptability may facilitate identification of quality improvement opportunities that could reduce rejection rates & improve patient care In a single institution study from Denmark specimens rejected was up to 2.2% in the emergency dept No information from developing countries

15. Analytical:Turn Around Time Are they discussed with clinical staff Which tests need to be have TAT s that will have a clinical impact

16. Result reporting Lab result availability before morning rounds Important for diagnosis and delay in mx leading to LOS In a survey of 300 hospitals, 10% of FBC not reported before the reporting deadlines set by labs What percentage of lab reports are corrected as this may lead to corrective action that can reduce the release of incorrect reports

18. Integrity of samples :serum indices Serum indices have been used to assess condition and integrity of samples: these include the detection of mild icteric, haemolytic and lipaemic specimens which may interfere with analytical procedures Also provides an index of preanalytical quality which can be used to improve sample collection and transportation. In a study from Sweden, samples received from primary health care centres were more likely to be haemolysed Recently recommended that routine reporting of serum indices should be included in results sent back to physicians

19. Reference Change Values Concept first developed by Harris and Yasaka in 1983 to identify significant changes that occur in sequential set of results. A significant difference from the previous result very much dependent on the analytical variation and biological variation of the analyte. An opportunity to educate the physician and can have significant impact on patient management with resulting cost savings especially if clinician is ignorant of the variability

20. Interpretative reporting Reported that 5% of errors are due to misinterpretation of laboratory results by physicians Lab’s final product is the result and labs must therefore become patient focused Number of tests have grown and physicians need assistance & more patients have to be managed in shorter time Growing body of evidence that it improves quality of clinical care by reducing errors and costs Kilpatrick showed that addition of automated interpretative comment on thyroid function to GP’s improve patient compliance

21. Guidelines RCPath in 1998 defined guidelines & include - Results are unexpected - A decision on treatment is indicated by the result in combination with clinical details provided - A specific question has been pose but its not obvious if the results provide the answer - A clinician has ordered a test with which he is not familiar with

22. Areas where reports are relevant Coagulation disorders, Anaemia evaluations Endocrinology Serum protein analysis Toxicology TDM Autoimmune disorders

23. Test Methods How often are internal evaluations made ? Are assay precisions determined at critical concentrations for key assays ? Are reference ranges determined in your laboratory on locally sourced samples Does your point of care (POC) committee involve clinicians and other role players

24. Reflex Testing Any test that automatically results in the order in the order of one or more secondary tests based on preset criteria These criteria are usually set in consultation with clinicians and attracts an extra charge Reflex testing is important to prevent delays in diagnosis How often are these policies laid out or more importantly in consultations with clinical staff. Are there any signed agreements ?

25. Examples of Reflex Testing Cholesterol, Reflex to Lipid Profile If Cholesterol is >200 mg/dl, Lipid Profile is performed UA, Micro Only w/ Reflex to C&S If the microscopic shows WBC >5/hpf and/or bacteria >moderate, Urine Culture is performed TSH, w/ Reflex to Free T4 If TSH is 4.02, Free T4 is performed.

27. Critical Results Reporting of critical test values to physicians has recently come under intense scrutiny from accrediting organizations Medical and legal ramifications of not getting critical results to physicians Labs should advice, streamline the list of critical results that must be provided to caregivers. Recommended that call centres be set up

29. Clinical participation, training, education How often are clinical audits carried out ? How often are collaborative clinical audits carried out with clinical staff Audits of erroneous results Dept attends multidisciplinary team meetings Do lab staff participate in undergraduate and postgraduate lectures and tutorials How often is training carried out

30. Sentinel Events These are events that may be linked to patient damage eg How does your lab track Lost samples Lost results Wrong test performed Failure to report critical results to a senior physician Audit by cross correlation How often does your lab audit these events and how do you prevent them

31. Customer satisfaction How often are your services rated ? How often do you meet with customers How often are visits arranged to the lab Is there good communication with clinical staff eg wards, clinics, theatre, IC, emergency dept Lowest satisfaction surveys have been reported due to poor communication related to timely reporting, notification of significant abnormal results

32. Conclusion A quality clinical lab service might be described as performing the right test on the right person at the right time and interpreting the test correctly It is important that laboratories are patient focused and work as a team