Protecting the integrity of clinical laboratory test results.
The authors' inspection reports demonstrate that the improper alteration of patient data is not a rare aberration in private commercial clinical laboratories. Although laboratory surveyors could be trained to recognize this problem, the availability of unprotected test systems makes even trained inspectors ineffectual. Both regulatory agencies and professional accrediting agencies should be concerned that their surveyors may be placing a seal of approval on what are, in reality, compromised or even fabricated data. In proposing the regulations discussed in this paper, the FDA sought to "preserve the integrity of the agency's enforcement process." This goal will remain unattainable, however, until a mechanism has been devised to secure the original raw data produced by all of the analytical systems being used not only in clinical laboratories but also in environmental laboratories, pharmaceutical laboratories, etc. Laboratories, as well as regulatory agencies and accrediting bodies, need to be concerned on behalf of the patient, but laboratories may also need to be concerned on their own behalf. In the coming era of unprecedented cost constraints and competitive bidding, unscrupulous testing facilities or groups of such facilities could have a significant edge over their conscientious competitors if the issues raised here continue to be ignored. Although the analytical data management systems provide tremendous benefits, some have serious problems in ensuring the security of their data. However, if regulatory agencies, accrediting bodies, professional organizations, and the analyzer vendors make a united commitment, the problem of securing the integrity of analytical data could eventually be resolved. It is hoped that such a commitment will be made in the near future.
Duffy
G
G
New Jersey State Department of Health, Clinical Laboratory Improvement Service, Trenton 08625, USA.
Russell
A M
AM
D001322:Autoanalysis; D002624:Chemistry, Clinical; D005607:Fraud; D007753:Laboratories; D011786:Quality Control