CQC inspections have “little measurable impact” on services, analysis finds

Dr Ana will find links to The King’s Fund summary and full report on the CQC have been provided by Christopher Paris who explains how this approach to quality derives from ISO standards 1.

Schemes of accreditation through inspection are demanding on staff and funding. To validate them to the standard expected of other medical treatments is difficult or impossible. They are sold on a promise of quality (defined as compliance with a standard) but lack anything more than anecdotal evidence of their efficacy, effectiveness or value. Published reports tend to be of a non-critical nature because of cognitive dissonance around the disproportionate input and output of accreditation. Leaders fall into groupthink.

The report of Alkhenizan and Shaw included 51 peer-reviewed papers and cited 33. It excluded studies on staff attitudes and cost which may have been relevant. Negative findings tend not to be published and significant criticism exists in blogs outside the peer reviewed literature.

Shaw also published evidence that ISO 9001 accreditation was worse than hospital accreditation and both were only slightly better than no accreditation. He wrote, “There is little hard evidence of the impact of these systems on hospitals to justify the amount of time and money spent on organizational assessment, or to choose between available programmes.”2

DJ Pratt warned in 1995 that standards which lay down formalised procedures and require exhaustive documentation, such as BS 5750, do not ipso facto lead to quality assurance3. Professional staff are different from manufactured parts. Similar opinions have been expressed from the early days of these standards, so important expert opinions can be found outside the medical literature. Stone and Starkey4 and Charlton and Adras5 expressed concern about related systems of assessment corrupting UK universities. John Seddon is an established critic who promotes a systems thinking approach6 and engineer, Patrick O’Connor wrote of ISO 9000,

“The only rational solution to the situation that has been allowed to develop is to dismantle the structures that have been built around the standard, and to remove all aspects of compulsion, whether stated or implied. The standard should be used only as a guide to what should be included in a minimal quality system. The systems for accreditation and registration should be abandoned.”7

Each year assessors remind staff their visit is just a screening test. Inspection can’t assure the quality of anything they didn’t look at, which is a subtle way of saying they have no legal liability for the “confidence” they are selling. Margaret McCartney’s recent article has many points relevant to the problems of screening8. The non-clinicians who devised the compliance-based systems derived from BS 5750 would not have been aware of the limitations of screening. Christopher Paris and others have noted that many losses of life have occurred when confidence is placed in ISO-certified systems. The global standards and inspection bodies have eluded the scrutiny that the pharma industry is subjected to and this needs to change.

The weakness of compliance-based inspection provides no excuse not to improve quality. Healthcare workers in regions with limited resources would not be wise to copy bureaucratic systems of accreditation. Instead they should develop systems to improve quality for patients, not to enable the sales of standards that support the ISO or the employment of inspectors. Elaborate systems of dominance are unnecessary in settings where professional attitudes prevail.

From my own perspective in pathology, an optimal balance of quality and cost may need no more than checks on 1) qualifications and ongoing training through CPD. 2) Appropriate technical and medical oversight of internal QC. 3) Maintaining good scores in external technical and interpretive proficiency testing. 4) Periodic external oversight of these. Clinicians in other areas can develop this as appropriate to their situation.

A shortage of resources could be viewed as an opportunity to develop streamlined systems of assuring quality for patients without diminishing the lives of staff. Then publish strong evidence on how well they work. They may be superior.

1. Paris, C. Report: UK “Risk-Based” Healthcare Auditing Scheme Ineffective https://www.oxebridge.com/emma/report-uk-risk-based-healthcare-auditing-...
2. Anonymous. Weak evidence for ISO 9001 not being much good in hospitals https://isowatch.wordpress.com/2018/04/06/weak-evidence-for-iso-9001-not...
3. Pratt DJ. British Standard (BS) 5750 – quality assurance? Prosthetics and Orthotics International, 1995, 19, 31-36. http://www.oandplibrary.org/poi/pdf/1995_01_031.pdf
4. Stone, M. & Starkey, M. J Database Mark Cust Strategy Manag (2011) 18: 154. https://doi.org/10.1057/dbm.2011.18 http://www.palgrave-journals.com/dbm/journal/v18/n3/full/dbm201118a.html
5. Charlton, BG, Andras, P. Auditing as a tool of public policy: the misuse of quality assurance techniques in the UK university expansion. European Political Science 2002; 2, 24-35. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.580.8972&rep=re...
6. Seddon J. The case against ISO 9000 continues. https://vanguard-method.net/2016/01/the-case-against-iso-continues/
7. O’Connor, PDT. ISO 9000: Help or hoax? In In My Humble Opinion http://www.lulu.com/items/volume_67/113000/113721/6/print/imho5.pdf
8. Margaret McCartney: A summary of four and a half years of columns in one column. BMJ 2018;362:k3745. https://www.bmj.com/content/362/bmj.k3745