Quality Requirements and Standards

In 2006, gas stations around the country ran out of gas. Would you go to a gas station that had no gas? Now, would you use a laboratory that had no quality in their testing?

• Why do people go to a gas station?
• Why do people go to a hospital?
• Why do people go to a laboratory?
• Why do we have this issue?
• Here's some data on analytical quality today?
• Here's the conclusion!

May 2006

I’ve been intrigued by some of the reasoning that is guiding laboratory priorities and directions, particularly the emphasis on pre-analytic and post-analytic processes along with a disregard for the quality of analytic processes. You can see this emphasis in the IQLM recommendations for laboratory quality indicators.

As we discussed earlier, there are 6 indicators for pre-analytic processes, 5 indicators for post-analytic processes, and only 1 indicator for analytic processes. That analytic indicator is for accuracy in Point-of-Care testing, thus there is no analytical indicator for a healthcare laboratory. Obviously, that means analytical quality is no longer an issue in laboratories today! CMS confirms this conclusion by recommending that laboratories today can reduce the amount of QC performed from the previous minimum of 2 levels of control per day to 2 levels per week (EQC option 2 or 3) or 2 levels per month (EQC option 1).

Why do people go to a gas station?

Today I noticed that my favorite gas station was out of gas. Not a problem if I go there only to get coffee and doughnuts, but a serious issue if I go there only when gas is available. If the station is out-of-gas, then I’ll go down the street to a coffee shop. The core competency I expect from a gas station is to be able to provide gasoline for my car. I don’t go there just to get coffee or use the restroom. Those services are nice, but they are valuable mainly as additions to the core capability to provide gasoline.

Why do people go to a hospital?

It’s obvious that the core competency of a hospital is billing, right! Billing is most important to support the operations of the hospital and allow customers to have access to the facilities and services. If not billing, then it must be parking! Parking makes it easy to access the hospital, so it is very important to the patients. [I’ve been wondering if it might be a good moneymaker to expand these services to provide gasoline and car washes.] BUT, don’t you think that the patients really expect the hospital to be competent to deliver the healthcare services that they need! That would be there number 1 concern and the core competency that is needed. Parking is a pre-analytic process that’s important, but not essential if the hospital can’t deliver the needed medical services – no reason for the customer to try to access those services. Billing is a post-analytic process and becomes irrelevant if the hospital can’t deliver services that are billable.

Why do people go to a laboratory?

Obviously it’s to have blood drawn or to deliver other specimens for analysis! Therefore the pre-analytic processes are very important if those specimens are to lead to reliable test results. BUT, the real competency that is expected from the laboratory is that it can produce reliable test results, otherwise, people wouldn’t bother to submit specimens and it wouldn’t be necessary to produce and deliver reports. Getting the right answer is still the fundamental and core competency of a laboratory! Calling critical values is important to facilitate the use of test results for treatment, but the assumption is that the test results being produced are correct! If a laboratory can’t get the correct result, then it doesn’t need to collect specimens and report results.

Why do we have this issue today?

People argue that getting the correct test result isn’t important if you have mis-identified the patient, collected the wrong specimen, or ordered the wrong test. True, but that doesn’t change the core competency expected of the laboratory. You shouldn’t be ordering tests and collecting specimens from patients if the laboratory can’t get the correct answer.

The real issue today is that many people assume the analytical quality of laboratory tests is better than needed for medical diagnosis and treatment, therefore it is appropriate to pay attention to other pre-analytic and post-analytic factors that affect the reliability of the testing process. BUT, there’s no data to prove that analytical quality is better than needed for medical applications! This is a myth – a mistaken yearning, theory, or hypothesis.

What is the quality needed for medical applications? If you can’t answer this question, what makes you think we are somehow achieving that unknown quality!

What QC is needed to guarantee achievement of the intended quality? Obviously, this is a difficult question in the absence of knowledge of the quality needed for medical applications. The right QC depends additionally on the precision and accuracy observed for the analytical method in the particular laboratory. The right QC will vary from test to test because there are different quality requirements for each test and different performance characteristics for each method.

Here’s some data on analytical quality today!

In an attempt to debunk this myth that analytical quality is better than needed for medical care today, we recently published a paper titled “The Quality of Laboratory Testing Today: An assessment of sigma-metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance” [Westgard JO, Westgard SA. Am J Clin Pathol 2006;125:343-354]. Here’s the abstract:

“To assess the analytic quality of laboratory testing in the United States, we obtained proficiency testing survey results from several national programs that comply with the Clinical Laboratory Improvement Amendments (CLIA regulations). We studied regulated test (cholesterol, glucose, calcium, fibrinogen, and prothrombin time) and nonregulated tests (internal normalized ratio [INR], glycohemoglobin, and prostate-specific antigen [PSA]). Quality was assess on the sigma-scale with a benchmark for minimum performance of 3-sigma and a goal for world-class quality of 6-sigma. Based on the CLIA criteria for acceptable performance in proficiency testing (allowable total errors [TEa]), the national quality of cholesterol testing (TEa=10%) is estimated as 2.9 to 3.0 sigma; glucose (TEa=10%) 2.9 to 3.3 sigma; calcium (TEa=1.0 mg/dL) 2.8 to 3.0 sigma; prothrombin time (TEa=15%) 2.8 to 3.0 sigma; INR (TEa=20%) 2.4 to 3.5 sigma; fibrinogen (TEa=20%) 1.8 to 3.2 sigma; glycohemoglobin (TEa=10%) 1.9 to 2.6 sigma; PSA (TEa=10%) 1.2 to 1.8 sigma.”

Here’s the conclusion!

The analytic quality of laboratory tests requires improvement in measurement performance and more intensive quality control monitoring than the CLIA minimum of 2 levels per day.