The Royal College of Pathologists has published a draft report entitled How to assess the quality of a pathology service. Report of a meeting held to discuss the evaluation of medical laboratories in the context of health service reform.
Despite praising ISO 15189, or perhaps having to play along with the inspection cartel because there seems to be no choice, the College seems unconvinced by at least some of the inspectors’ dogma. But it didn’t get its doubts from reading this blog. The College’s criticisms are phrased far too politely for that.
It doesn’t even identify accreditation as a disease. Perhaps that job must fall to the psychiatrists.
Its plan is for ongoing self-inspection bureaucracy beyond CPA. It can never bring a cure for whatever the poorly-defined disease of low quality is. Just perpetual inspection.
Page 3 says,
“Recent changes have drawn attention to two broad areas of deficiency:
1. Laboratory accreditation concentrates too much on the laboratory, on areas where laboratory managers have control. It pays little attention to what happens before a patient’s sample reaches the laboratory or after the report leaves it. This is despite evidence from the National Patient Safety Agency, among others, that the majority of patient safety incidents occur not in the laboratory, but at these “interface” zones. It ignores demand management; the need to avoid unnecessary testing and the need to use laboratory tests when they can genuinely improve outcomes. Consequently, if we are concerned about improving patient outcomes, we need systems to measure the whole service, from the decision to use a laboratory test through to the interpretation and clinical implementation of the result of the test.”
Quite. CPA accreditation is inadequate. Pre- and post-analytical factors invalidate most of the claims of accreditation. Readers of this blog and many others know that.
But are such words not in danger of inviting CPA to measure and inspect every aspect of the rest of the clinical service also? The extension of an ill-founded regime will not improve care.
“2. Most available quality evaluation systems have focussed on the needs of the pathology manager who wants to produce accurate results. They have not considered adequately the needs of the user; neither the patient, where phlebotomy, sample delivery and report availability are likely to be important nor (to any great extent) the clinician who requests tests. They have not considered adequately the needs of those who commission to pay for the service, because the division between purchaser and provider was not an issue when the system was designed. Consequently (and with the arguable exception of some benchmarking services which are not universally used) they do not consider efficiency. Systems to deliver appropriate demand management are neither required nor assessed.”
By the admission of ISO 17025, ISO 9000 was inadequate to assure the technical validity of laboratory results. This justified an oppressive raft of unprofitable obligations under ISO 17025.
Now the failure of ISO 15189 to truly address quality as it matters to users – not inspectors – requires yet another set of standards. It’ll take a few years to get them into an ISO.
Is there a pattern emerging here?
The College report is rather mixed with some excellent statements like,
“If those who have to commission laboratory service demand CPA accreditation (and they have no obligation in law to d0 so) [unlike ISO 17025!] the process gives them no further information on how to evaluate a service. Market forces only work if the purchaser has tools to evaluate the quality of the product. For the reasons given above, purchasing decisions based only on accreditation status and price would risk being seriously flawed.“
“The only “real” test of the quality of a medical laboratory service is its effects on patient outcomes. Anything else is a surrogate measure. Direct measurement of effect on outcomes is rarely possible, so surrogate measures have to be used, but their limits must be understood and a suitable spread of measures is essential.”
But then it goes on to wallow in various indirect indicators of quality that may not pass muster if they were diagnostic tests.
The College’s solutions to the inadequacy of CPA and ISO 15189? Tightening targets, measurement of compliance/non-compliance, surveys, but some professional freedom and a slimming of the multiple regulators’ overlaps in reporting. The document is well-intentioned – to address meaningful quality rather than to enable inspection – but is too heavily constrained by the MBA command and control management strait-jacket that has been killing the country since the late 80s.
A broader vision is needed. It’s the world outside the inspection cartel’s box. They should have read about the perils of obsessive measurement.
Since they haven’t, the folly of the last two decades measuring against targets (outcomes now) is about to grow…