Abstract
In a medical biochemistry laboratory, under ISO 15189:2002, the postexamination process includes the systematic review, formatting and interpretation, authorization for release, reporting of results, transmission of results and storage of samples of the examinations. Results must reach the user in a timely and secure manner.
Clause 5.8 of the standard sets out that ‘the laboratory shall establish policies and practices to ensure that results distributed by telephone or other electronic means only reach an authorised receiver’. The CPA (UK) Ltd Standards for the Medical Laboratory 2010 set out the requirements for giving reports by telephone. Among the requirements demanded of the laboratory management are formalized procedures for (a) the circumstances in which reports may be given; (b) the nominated individual who may give reports; and (c) the individuals who may receive reports. 1
In November 2010, the Royal College of Pathologists (RCPath) published a document ‘Out-of-hours reporting of results requiring urgent clinical action to primary care: advice to pathologists and those that work in laboratory medicine’. This was in response to reports of the inability of laboratory staff to find an appropriate primary care physician to act on a markedly abnormal, and sometimes life-threatening, result outside of conventional working times.
The general principle is set out in section 4 of the RCPath document. ‘The responsibility of the laboratory staff is to communicate the markedly abnormal test result to the clinical team – either the GP who made the request or to the out-of-hours provider’. The next statement is naïve. ‘It is the responsibility of the requesting team to review results of tests that they have requested and have proper handover arrangements in place to review and act on abnormal results after hours. The Primary Care Trust (PCT) or commissioning body has a responsibility to ensure that adequate out-of-hours cover arrangements are available, and that details of those arrangements are communicated to the laboratory. PCTs or GP commissioning bodies should be asked to inform the laboratory of specific arrangements for making telephone contact with a GP out of hours.’
It is recognized that the out-of-hours cover doctor will have limited access to patient information. These are clear patient safety issues. The RCPath document does not address the context of independent GPs outside a state system. It downplays the ethical responsibility of the doctor to the individual patient and the parallel role of the consultant chemical pathologist and consultant clinical scientist in patient care.
The General Medical Council requires doctors to put the care of a patient as a first concern. Therefore it is the duty of the doctor to provide any laboratory to which patient samples are sent with contact arrangements in the event of a life-threatening or very urgent patient result. The clinical biochemistry laboratory consultant must also place the care of the patient first. All requests to the laboratory are referrals to the consultant. My experience is that locum and out-of-hour services are unsatisfactory means of dealing with dangerous laboratory results. On occasions when an appropriate doctor cannot be contacted, there has often been no information on the address of the patient. Where an appropriate professional cannot be traced but the patient's address and phone number is available, I have directly contacted the patient. Where an address only is available, I have rarely asked the police to call and arrange for transfer of the patient.
I believe that access to the direct personal cell phone number of every requestor of laboratory tests which may require urgent intervention should be incorporated into the governance requirements for clinical laboratory accreditation. Since I instituted this policy in 2010, there have been no cases where the laboratory could not find the relevant GP. A minority of GPs were resistant to providing the information and ultimately 2.5% refused and were asked to go elsewhere. This stipulation should also be a requirement for practice accreditation in primary care and must now be considered a best practice standard when GP practice registration is introduced under the Care Quality Commission in the UK in 2013.
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