MJA: Ensuring quality in all phases of the pathology cycle

Ensuring quality in all phases of the pathology cycle

Laboratories need to monitor and improve their procedures to ensure that they always deliver the correct test results for the correct patient to the correct doctor

MJA1996; 165: 125-126.

There is an unfortunate perception that pathology laboratories are only interested in performing tests, whereas, in reality, they are responsible for a cycle of activities which begin before and conclude after the actual testing. These activities include consultation between the clinician and pathologist, accurate identification of the patient and referring doctor, correct collection and storage of the specimen, timely and accurate delivery and readability of the result, and, if necessary, more consultation between the pathologist and the clinician.

As a consequence of more than 30 years of the Royal Col lege of Pathologists of Australasia (RCPA) leading the provision of well-organised proficiency testing programs, and the advent of medical (pathology) laboratory accreditation with mandatory National Association of Testing Authorities-RCPA registration in 1986, ¹ the quality of analysis in Australian laboratories is as good as, if not better than, that in most developed countries. However, it has been recognised that there are still significant problems with the activities that surround analysis in many laboratories.

In this issue of the Journal, Khoury et al. ( page 128 ) present an insight into the extent of the problem. Although there were an equal number of laboratories which compared less than favourably with their peers in each of the analytical and transcription-error aspects of the study, the error rate would appear to be much higher in the latter. While some of the 14 laboratories they looked at had near-perfect records in transcribing patient details, median error rates for various elements of the data were in the order of 3%. One laboratory documented an overall transcription-error rate of nearly 40%.

If these findings are extrapolated to all laboratory activity in Australia, errors must abound in alarming numbers. In a similar study of 417 laboratories (eight from Australia), Nakhleh and Zarbo ² found deficiencies of identification and recording in 6% of surgical pathology requests.

While neither of these studies addressed the question of whether such errors affect patient outcomes, there is indirect evidence that a minor, preventable systems error can have serious consequences. ³ The Quality in Australian Health Care Study ⁴ showed that a significant number of patient adverse events were related to system errors. These were often errors of omission related to investigations, such as failure to act upon results of findings, or failure to carry out indicated tests. In such cases it is likely that one health care worker's error of omission results from another's error of commission, such as the incorrect delivery of a report.

It is likely that most errors occur because of system problems. Typical examples are poor staff training and non-existent work manuals. Inadequate computer systems with insufficient internal audit checks and poor or no access to the hospital Master Patient Index and ward information system are the bane of many laboratories' existence. Despite a belief that those in private practice are more skilled at the activities surrounding analysis, the article by Khoury et al. indicates that the problems are widespread in both public and private sectors.

Where then does the remedy lie? The first step in rectifying this situation is to recognise and document that the problems exist. Pathology laboratories should recognise that their professional responsibility encompasses a whole cycle of events, starting with the requesting doctor initiating an investigation necessary for the management of a patient, right through to recognising the significance of the results for the management of the patient. Then, laboratories should be given, and accept, the authority and responsibility necessary to fulfil their professional obligations to both patient and clinician.

Australian pathology laboratories have been slow to adopt total quality improvement processes. Unfortunately, there are even those who believe that too much money is already being spent on mandatory quality activities. This near-sighted stance ignores the significant costs to both patients and the community of preventable adverse events, not to mention potentially expensive medicolegal exposure. Without some mechanism for documenting the problems they experience or cause, laboratories are in no position to begin improving the quality of their services. An example of such documentation stipulating the requirements for laboratory quality systems has been provided by the International Standards Organisation. ⁵

Because so few laboratories monitor their pre- and post-analytical activities, there is little information from which to develop the necessary benchmarks. The College of American Pathologists has introduced "quality probes" programs to gather data from which realistic benchmarks may be re commended. These programs also document the features of laboratory operations and organisation that correlate with better quality outcomes. A good example of this is a study of wristband identification errors which showed that hospitals with the lowest error rate had systems where the pathology phlebotomists played a crucial role in monitoring wristband conformity to the required standard. ⁶ Such peer review techniques, which have delivered improvement in the quality of laboratory analysis, may bring about similar improvement in these other areas of laboratory operations. Another technique that has been productive in other procedural areas is incident monitoring. ⁷ It may very well yield fruitful results if applied to laboratory activities.

There is obviously much scope for documenting, understanding and minimising the types of laboratory errors highlighted by Khoury et al. However, a systematic and co ordinated approach will be required from those involved in laboratory medicine to achieve the all-round quality of performance that clinicians and their patients should come to expect.

Stewart J Bryant
General Manager, SouthPath, St George Hospital Campus, Sydney, NSW

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