ISO standards have not been as successfully pushed into the USA as they have been in Europe. The US has CLIA instead, and it fails too. In a disproportinate reaction to public concern over one or more deaths due to misread pap smears, Congress passed the Clinical Laboratory Improvement Act of 1988 to regulate all laboratory testing. Unlike banks, no lab is too big to fail and no error is too small to cause the failure.
I know of an instance where a CLIA license was revoked over a clerical error that resulted in PT results for blood gasses (performed under the CLIA number of another lab)being reported under the CLIA number of the main clinical laboratory which did not even perform blood gas testing. The error resulted when the PT material was ordered, so the results were reported under the main laboratory number instead of the number for the blood gas laboratory. No inadvertant referral of PT material to another laboratory, no quality issues or patient care issues, just a clerical mistake entering the wrong CLIA number. The inspectors admitted that they could not think of an instance that they could deem as “unintentional” and that they were not allowed to make judgement calls in this matter. The punishment does indeed exceed the crime! And beware if there is more than one CLIA number in your institution!
Prof. James Westagard has criticised aspects of CLIA heavily.
“Why should we oppose the CMS recommendations on Eqc? After all, Eqc makes it easier for laboratories to be in compliance with the CLIA QC regulations. Isn’t that better? Won’t the improved compliance statistics assure the public that healthcare laboratories are doing a good job?
“NO, compliance should not be the goal and compliance statistics should not be misinterpreted to suggest improvements in the quality of laboratory testing! The goal must be to provide quality testing services! Compliance equates to average, being good enough to stay out of jail. Quality is about excellence, being good enough to take proper care of our patients. The Final CLIA QC rules and interpretive guidelines set the standard so low that QC now represents “Quality-less Compliance” rather than Quality Control.
“The Eqc options are so obviously and absurdly inadequate when judged against CLIA’s own standard that QC “should detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance, monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance.” The recommended evaluation protocols are so obviously and absurdly inadequate. The idea that individual laboratories rather than manufacturers can and should take responsibility for documenting the effectiveness and performance of the internal procedural controls developed by the manufacturer is itself absurd, particularly in light of the staffing and skill issues in laboratories today. Manufacturers are best able to do that, not individual laboratories…” (emphasis added):
Some criticisms have parallels with the ISO standards’ deficiencies as interpreted by the enforcement bodies, even though the systems devised to enable the employment of inspectors err in different directions.
CLIA may have been invented by regulators but it was shaped by business interests with the money for lobbyists. Its Eqc “may allow Big Errors and provide little quality and little control“. It gets manufacturers off the hook, but has to remain realistic about what labs can do with ever-fewer and less qualified staff.
BS 5750 and its derivatives, ISO 15189 and ISO 17025 were invented to employ factory inspectors whose services had been dispensed with. The inspection systems were sold to regulators as “quality systems”, and effectively imposed on businesses through Government pressure, the ISO market coercion clauses that prevent dealing with non-ISO-accredited businesses, or legislation.
ISO inspectors fail in the opposite direction to CLIA and demand that extensive methodological evaluations IQC, EQA, witnessing of staff and gap analysis must be conducted for methods and products supposedly well-validated, certificated and accredited previously.
Both the CLIA and ISO systems are not truly about quality but enforcing compliance.