PT/EQA for the Total Laboratory Testing Cycle: Focus on Pre-Examination

PT/EQA for the Total Laboratory Testing Cycle: Focus on Pre-Examination Michael A Noble MD FRCPC Clinical Microbiology Proficiency Testing University of British Columbia Vancouver BC Canada

The North America history of PT In 1945-6 the laboratorians in Philadelphia were concerned because it had become conventional for clinicians to collect patient samples and send them to multiple laboratories for testing. The results from the collective group would be compared and analyzed for interpretation Sunderman Sr. and others devised a battery of chemistry samples to determine the Quality of laboratory testing LabQuality Days 2016 2

The Results were NOT encouraging Assays ranged between ± 40-100 per cent of target values. Inter-laboratory and Intra-laboratory duplication were highly unreliable. 1947. BELK WP, SUNDERMAN FW. A survey of the accuracy of chemical analyses in clinical laboratories. Am J Clin Pathol. Nov;17(11):853-61. LabQuality Days 2016 3

This study lead to Positive Change State wide Proficiency Testing as a measure of interlaboratory analytic chemistry Quality College of American Pathologists develop Multiple Discipline Proficiency Testing National Regulation: US Clinical Laboratory Improvement Act (CLIA) LabQuality Days 2016 4

But there is a downside As ground breaking as CLIA became, it can also be viewed as resulting in a narrow and limited perspective of Proficiency Testing SOLELY FOR REGULATORY PURPOSES --- CLIA is INDIFFERENT to Proficiency Testing as an Internal Quality Measure Proficiency Testing as an Education Measure LabQuality Days 2016 5

And there is an additional problem CLIA specifies the requirements for regulatory based proficiency testing but includes only the examination activities of laboratory testing. LabQuality Days 2016 6

Meanwhile, in Europe Another model of Quality Assessment was being developed, similar to Proficiency Testing but different. External Quality Assessment LabQuality Days 2016 7

The TWO MODELS Approach Proficiency Testing Regulatory Tool to assist Accreditation and Regulatory Authorities Internal Quality Monitor through required (Root Cause Analysis) No incentive for change until the underlying regulatory base changes External Quality Assessment Regulatory Tool to assist Accreditation and Regulatory Authorities Internal Quality Monitor through required (Root Cause Analysis) Provider of Educational Materials for Quality Improvement No inhibition to flexibility and change LabQuality Days 2016 8

The TWO MODELS Approach Proficiency Testing Regulatory Tool to assist Accreditation and Regulatory Authorities Internal Quality Monitor through required (Root Cause Analysis) No incentive for change until the underlying regulatory base changes External Quality Assessment Regulatory Tool to assist Accreditation and Regulatory Authorities Internal Quality Monitor through required (Root Cause Analysis) Provider of Educational Materials for Quality Improvement No inhibition to flexibility and change LabQuality Days 2016 9

Medical Laboratory Total Testing Cycle Pre-Exam Collection Pre-Pre Examination Test Ordering Patient Post-Post Examination Result Interpretation Pre-Exam Transport Sample Examination Post-Examination Report LabQuality Days 2016 10

Medical Laboratory CLIA Required PT 0% 0% Pre-Exam Collection Pre-Pre Examination Test Ordering Patient Post-Post Examination Result Interpretation Pre-Exam Transport Sample Examination 100% Post-Examination Report LabQuality Days 2016 11

80% Medical Laboratory Errors Total Testing Cycle 15% Pre-Exam Collection Pre-Pre Examination Test Ordering Patient Post-Post Examination Result Interpretation Pre-Exam Transport Sample Examination 5% Post-Examination Report LabQuality Days 2016 12

If it makes sense here I rob banks because that's where the money is. Willie Sutton Famous American Bank Robber LabQuality Days 2016 13

How about here? We should be EQA-challenging medical laboratories in the Pre and Post Examination Phases because that's where the errors are. LabQuality Days 2016 14

What do Laboratories think about EQA Beyond the Examination Phase? Clinical Microbiology Proficiency Testing Electronic survey Responses from all CMPT provinces across Canada October 2015 72 Percent response LabQuality Days 2016 15

How important is it that Proficiency Testing programs challenge laboratories on issues such as Pre-examination, Laboratory Safety, Quality Management, and Post-examination phase? Weighted Average 86.4% LabQuality Days 2016 16

How Many EQA Programs Provide Pre-Examination Challenges? EQALM Microbiology Working Group Electronic survey Wide international distribution of programs November 2015 52 Percent response LabQuality Days 2016 17

39.1% LabQuality Days 2016 18

Can We Interpret these two Results? Two small samples, different geographic areas All are focused on Microbiology laboratories The laboratories are ahead of the EQA programs in seeing importance in Pre- Examination EQA, but 40 Percent of EQA programs providing Pre- Examination EQA indicates that EQALM members programs are very aware of the opportunities and value. LabQuality Days 2016 19

Potentially Addressable Areas of Concern Should the samples be rejected if they are Leaking? Appropriate and sufficient patient identifiers? Improper/inadequate clinical information? Inappropriate transport? Excessive delay? Patient related but not patient direct Food Home Environment Pet Cultures Regionally different policies may complicate grading for challenges that are sent to multiple geographies. LabQuality Days 2016 20

CMPT Paper Challenge Program Process Advisory Committee selects: Topic Text Choices Best/Preferred Responses Unacceptable Responses Challenge questions are sent out at the same time as regular sample challenges. Deadline for response is 14 days (way too long!!!) Grading is based solely on response, but laboratory complexity may be taken into consideration. Informative Critique is written Appeals are accepted and reviewed. LabQuality Days 2016 21

Example 1 PC134 February 2014 Your laboratory accessioning bench received a set of 2 blood culture bottles (2 aerobic bottles) collected from an 87 year old male. On observation, both bottles appeared to contain a scant amount of blood. Phlebotomist record indicates the total volume of blood collected from the patient was 2 ml, of which 1 ml was dispensed in each blood culture bottle. The phlebotomist described the patient to be very ill with fragile veins and recollection would be very difficult. LabQuality Days 2016 22

Example 1 PC134(continued) February 2014 Which option that best describes your laboratory protocol? A. Culture the two vials in the blood culture analyzer for up to 5 days B. Culture the two vials in the blood culture analyzer for up to 5 days but flag (record) the vials as inadequate collection volumes. C. Reject the two vials as insufficient volumes and unacceptable for culture. D. Immediately forward/refer the two vials to a facility capable of performing advanced direct testing, such as MALDI TOF MS. E. Sample not applicable to or not normally processed by our laboratory LabQuality Days 2016 23

Example 1 PC134(continued) February 2014 Committee considerations Blood cultures are critical tests that must be collected and performed optimally to provide optimal information. Adding inadequate blood volume is problematic, but does occur especially in elder patients because of inadequate veins and low blood pressure Clinician needs to be aware that blood volume inadequacy may result in falsely negative results. LabQuality Days 2016 24

Example 1 PC134(continued) February 2014 Committee Grading A. - 1 of 4 Can not interpret negative result B. - 4 of 4 Most informative choice C. - 0 of 4 Refusal to culture is inappropriate D. - 1 of 4 Referral in unhelpful. Statement is nonsense E. - Ungraded LabQuality Days 2016 25

Example 1 PC134(continued) February 2014 Reported Results LabQuality Days 2016 26

Example 2 PC132 August 2013 A physician sends a requisition along with a throat culture swab to the laboratory. The requisition includes the patient's name, Thomas James Smith, date of birth and healthcare number. The only information written (handwritten) on the throat culture swab only TJ Smith. How would you proceed? LabQuality Days 2016 27

Example 2 PC132(continued) August 2013 A. Phone the physician office and request recollection of the throat culture swab B. Reject the throat culture swab C. Phone the physician office and request relabeling of the throat culture swab D. Process the throat culture swab with the requisition E. Sample not applicable to the laboratory or not normally processed in the laboratory LabQuality Days 2016 28

Example 2 PC132(continued) August 2013 Committee considerations Throat swabs are rarely critical samples. They are samples that can be recollected, usually without undue inconvenience. Sample identifiers are critical to ensure that the sample and the requisition match. Delaying processing the sample by sending it back to a physician office or waiting for re-labelling can result in overgrowth and wrong results. LabQuality Days 2016 29

Example 2 PC132(continued) August 2013 Committee Grading A 4 of 4 Require recollect. Appropriate and acceptable B 4 of 4 Reject and discard. Appropriate and acceptable C 1 of 4 Request relabel. High inconvenience with little benefit D 0 of 4 Process as is. E Ungraded Unacceptable risk for error LabQuality Days 2016 30

Example 2 PC132(continued) August 2013 LabQuality Days 2016 31

Example 2 PC132(continued) August 2013 An appeal was raised because the history should have differentiated whether the story referred to an outpatient setting or a hospitalized patient. Practice with respect to requiring a physician to come to the laboratory and confirm the sample identity would be done for a hospitalized patient. Appeal was rejected. LabQuality Days 2016 32

CMPT Paper Challenges 2009-2015 Pre- Post- Examination Safety Examination Other PC134 Feb2014 PC144 Feb2015 PC142 Aug2014 PC102 Aug2010 PC132 Aug 2013 PC124 Feb2013 PC122 Aug 2012 PC114 Feb2012 PC104 Feb2011 PC112 Aug2011 PC092 Aug2009 PC094 Feb2011 LabQuality Days 2016 33

Year over Year Performance Paper Challenges LabQuality Days 2016 34

Pre-examination Challenges can be in a variety of formats APPROACHES Paper Challenges Graphic Clips ADVANTAGE Versatile Versatile RISK Literal Interpretation (Great Potential) Video Clips Simulated Samples Realistic Realistic Expensive Limited Application LabQuality Days 2016 35

An Example of one Graphic Prototype we are developing LabQuality Days 2016 36

In Summary The laboratory world has changed and it is appropriate to extend PT/EQA to cover a broader view of the total laboratory testing cycle, including pre-examination and post-examination issues. Approaches may be less technical but can be monitored and measured in a consistent approach. Our experience is that performance is aligned with laboratory complexity, however, laboratory improvement can be measured. Over time Paper Challenge scores progressively improve LabQuality Days 2016 37

In Conclusion EQA can and should cover the whole laboratory cycle for better Quality and better Care LabQuality Days 2016 38

In conclusion Pre-Exam Collection Pre-Pre Examination Test Ordering Patient EQA Post-Post Examination Result Interpretation Pre-Exam Transport Sample Examination Post-Examination Report LabQuality Days 2016 39