Trends

Are you ready for the latest lists for the laboratory? IQLM is preparing a list of Quality Indicators, as well as a list of things that physicians don't like about laboratorians, and a list of things that laboratorians don't like about physicians. In all of this "Top Tenning," is there anything useful?

What's important to the nation?

What's important to the physician?

What's important to the laboratory?

What do these lists have in common?

How should measures of quality be reported?

Airline baggage update

Update on laboratory performance?

References

March 2006

The Institute for Quality in Laboratory Medicine, (IQLM), has adopted a mission to advance patient safety through development of quality indicators for laboratory medicine. At their 2005 conference [1], IQLM explained that these indicators should be the answer to the question: “If congress wanted to quickly know about American’s laboratories, what information should they have? Laboratory medicine’s contributions to the nation’s health, and what is important to the nation should be important to its laboratories.”

What’s important to the nation?

IQLM has recommended the following set of indicators as the answer to that question [2]:

1. Diabetes monitoring
   
2. Hyperlipidemia screening
   
3. Patient identification
   
4. Test order accuracy/appropriateness
   
5. Blood culture contamination
   
6. Adequacy of specimen information
   
7. Accuracy of point-of-care testing
   
8. Cervical cytology/biopsy correlation
   
9. Critical value reporting
   
10. Turnaround time
    
11. Clinician satisfaction
    
12. Clinician follow up

The national guidance to laboratories is to focus their efforts on pre-analytic and post-analytic parts of the total testing process. Indicators 1-6 have to do with pre-analytic factors, whereas indicators 8-12 have to do with post-analytic factors. Only indicator 7 has to do with getting the correct test result and that focuses on point-of-care testing sites (a hidden assumption: the accuracy of non-POC testing is so great we don't have to "indicator" it).

What’s important to the physician?

In a related development, IQLM is sponsoring a series of presentations on “Controversies in Laboratory Medicine.” The first presentation [3] deals with the “top 5 issues” from the physicians’ perspective and also from the laboratory perspective. Here’s the physician list:

1. Failure to provide useful information to help interpret a test result (e.g., likelihood ratios);
   
2. Standardization of reference ranges and units of measurement (confusing when physicians practice in different settings that have different units and different reference ranges);
   
3. Laboratory policies that interfere with patient care (critical value reporting to the wrong physician, cancellation of test orders, disposal of specimens that appear incorrectly labeled, timely notification when QNS, inflexibility of rules or policies without adequate explanation);
   
4. Performance of the wrong test;
   
5. Miscellaneous: Changes in reference range, assay methodology, or specimen requirements without notification or explanation; turnaround times that are too slow; failure to recognize that a test was ordered stat.

What’s important to the laboratory?

Here’s the top 5 list of issues from the laboratory’s perspective:

1. Critical values reporting (Hey Doc, where are you?);
   
2. Inappropriate ordering of STATs (Not another STAT!);
   
3. Missing history (What’s the Story?);
   
4. Inappropriate testing ordering (What do you really want, Doc?);
   
5. Rudeness (We get no respect!)

Notice that laboratories and physicians often have conflicting views and interests:

• Appropriate test orders is an irritant between physicans and laboratories, including the ordering of STATs;
  
• Specimen information and processing is an irritant between physicians and laboratories when specimen labeling and identification policies are enforced;
  
• Critical value reporting is also seen as an irritant to both the physician and the laboratory;

What do these lists have in common?

We can see that the quality of laboratory testing has to do with ordering the right test on the right patient, getting the right specimen on the right patient processed right, getting the right answer (assumed) on the right specimen from the right patient, and reporting the right answer on the right patient to the right physician in the right time.

Those are the basic dimensions or measures of quality for laboratory testing services!

How should measures of quality be reported?

The measurement of quality on the “sigma-scale” facilitates the benchmarking of quality across processes, organizations, and industries. The goal for “world class quality” is 6-sigma. Typical business processes are expected to be about 4-sigma. The minimum quality for production processes is recommended to be 3-sigma..

Use of the sigma-scale and appropriate benchmarks makes quality more understandable for customers and consumers. One useful benchmark is airline baggage handling, which had been quoted as being 0.4% errors or 4000 DPM (Defects Per Million). That benchmark was referenced in Nevelainen’s paper [4] which first introduced quality on the sigma-scale to the clinical laboratory community. The figure for baggage handling was referenced to a paper [5] by Mikel Harry, who was one of the original architects of Six Sigma when working at Motorola in the 1980s [6].

The benchmark of 4000 DPM converts to 4.15 on the sigma scale. In comparison, Nevelainen showed that data from clinical laboratories demonstrated generally lower quality for several pre-analytic and post-analytic processes, e.g.,

• 3.60 for order accuracy,
  
• 3.65 for duplicate test orders,
  
• 4.00 for wristband errors,
  
• 2.20 for TDM timing errors,
  
• 4.15 for hematology specimen acceptability,
  
• 4.25 for chemistry specimen acceptability,
  
• 3.30 for surgical pathology specimen accessioning,
  
• 2.95 for cytologoy specimen adequacy,
  
• 3.85 for laboratory proficiency testing,
  
• 3.60 for surgical pathology frozen section diagnostic discordance,
  
• 3.45 for PAP smear rescreening false negatives, and
  
• 4.80 for reporting errors.

These figures provide an average of 3.65, as compared to the 4.15 benchmark for airline baggage handling. Based on this comparison, many laboratory testing processes are not of as high quality as airline baggage handling.

Update on airline baggage handling

The 4.15 benchmark comes from a Quality Progress paper that was published in 1998, thus this figure is now at least 8 years old. Given the competition in our deregulated airline industry and given customer demand for improvements in service in competitive industries, we should expect that baggage handling today would operate at a much higher level of quality than before.

USA Today published new figures on baggage handling this month [7]. Here’s the new data, airline by airline:

Airline	Reports/1000 Passengers	Yearly increase	DPM	Sigma Short Term
US Airways	9.62	+81%	9620	3.85
Delta Air Lines	7.09	+37%	7090	3.95
American Airlines	5.92	+25%	5920	4.00
Northwest Airlines	4.86	+15%	4860	4.10
America West Airlines	4.33	+9%	4330	4.10
United Airlines	4.28	+9%	4280	4.10
Southwest Airlines	4.25	+27%	4250	4.10
Continental Airlines	4.12	+15%	4120	4.15

Whoops! These figures show that the quality of airline baggage handling has actually gone down, not up! And the quality for all airlines actually got worse in the last year (see yearly increase column where all the percentages are positive). The benchmark now appears to be closer to 4.0?.

Update on laboratory performance?

What’s happened to laboratory performance during this same period of time? The Nevelainen paper was published in 2000, which means the data comes from an earlier time, at least a year or two earlier. Has laboratory performance gotten better or not?

Where’s the data? Is anyone monitoring and measuring the quality of laboratory testing services today? Will IQLM take on this task? Will CAP Q-Probes be adapted to this task? Will CMS do this as part of their monitoring of regulatory effects and compliance? Does CMS have data from inspections and surveys that could provide some of these measures?

If the Congress wanted to know the quality of laboratory services, does anyone have the data to answer the question?

References

IQLM Conference. Recognizing Excellence in Practice. April 28-30, 2005, Atlanta GA.


Hilbourne L, Meier F. Quality Indicators Workgroup Report. IQLM Conference, April 29, 2005, Atlanta, GA.


Butterly JR, Horowitz RE. Top 5 issues that irritate physicians about the laboratory vs top 5 issues that irritate the laboratory about physicians. Medscape General Medicine. 2006;8(1):47. www.medscape.com

Nevelainen D, Berte L, Kraft C, Leigh E, Morgan T. Evaluating laboratory performance on quality indicators with the six sigma scale. Arch Pathol Lab Med 20000;124:516-519.


Harry MJ. Six Sigma – a breakthrough strategy for profitability. Quality Progress 1998;31(5):60-64.

Harry MJ, Schroeder R. Six Sigma: The breakthrough management strategy revolutionizing the world’s top corporations. Currency, New York, 2000.


"Airlines lost 10,000 bags a day in ’05. USA Today, February 17, 2006.

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.