Closing the loop in medical diagnostic laboratory testing phases

CDC IN SOUTH AFRICA BLOG

August 7, 2014, 2:00 pm ET CDC-South Africa, Laboratory Advisor, Adeboye Adelekan

Laboratory diagnostic tests play a critical role in the provision of relevant healthcare services. The tests are heavily relied on for making accurate diagnosis, and monitoring of treatment and treatment outcomes. Prevention interventions and surveillance activities also depend on diagnostic tests to function effectively. Therefore, it is very important to make sure that laboratory services are of high quality – as medical decisions made based on them could only be as good as the quality of the results supplied.

Laboratory testing is an integral part of a cycle consisting of three phases: pre-analytic, analytic, and post-analytic phases. The quality of all processes occurring in these phases, associated in a workflow, determine the quality of test or results e.g. accuracy, precision, reliability, turn-around time etc. However, most attention – developmental and strengthening efforts (e.g. quality assurance system, new technology, maintenance etc.) – has been focused on the analytic phase. The pre-analytic and post-analytic phases, which are also referred to as clinic-laboratory interface (CLI), have been largely neglected. Errors are known to occur in any of the phases, with majority of the errors being found to occur in the pre-analytic and post-analytic phases.

Laboratory Advisor, Adeboye Adelekan

Focus on facilities.

The testing processes that are more affected are those that occur outside the laboratory, meaning at healthcare facilities. Such processes include: specimen collection, storage of specimen, specimen packaging and transportation, completion of test forms, test ordering, test result collection and filing, and finally using and acting upon the results for patient management and decision making. Some of the errors particular to CLI include inappropriate test requests, misidentification of patient, inappropriate test tube, inadequate sample collection and transport, inadequate sample/anticoagulant volume ratio, insufficient sample, labelling errors, improper data entry etc. Often, adequate supervision of these processes is lacking or weak as some specimens that arrive at the laboratory are either not of the required quantity and/or quality, whereas in other instances the specimen tubes are empty. Clients’ test results are often not filed immediately at clinics, misplaced and as a result, the test re-ordered. Thus, delays in appropriate medical intervention and waste of scarce resources occur. For the provision of high quality laboratory services that respond to healthcare needs, it would be necessary to pay attention and strengthen all the phases in laboratory process cycle.

Various assessments and reviews performed at healthcare facilities around the country have shown weaknesses in CLI. The CDC South Africa Laboratory Program is working towards assisting in addressing these weaknesses and strengthening laboratory services, in collaboration with local partners, to support the improvement of CLI activities and processes. As part of the CDC South Africa laboratory services strengthening efforts, baseline assessments were conducted by implementing partners at the supported facilities. Findings from the assessments have shown concurrence in the weaknesses of CLI with other previous assessments conducted. In addition, the assessments have revealed long turn-around times for some tests, high specimen rejection rates, and gaps in management and coordination of laboratory services in some districts.

Based on these findings, various intervention plans and activities (e.g. trainings) have been developed and are being implemented. Furthermore, the Laboratory Program is providing support to strengthen collaboration and management of laboratory services utilization and oversight at the national, provincial and district level of the South African health sector. Also, the Laboratory Program is currently supporting the implementation of electronic gate keeping (EGK) to prevent or minimize irrational and wasteful use of laboratory services; hiring of district laboratory coordinators to facilitate coordination and communication between healthcare facilities and laboratories; a PEPFAR Laboratory Technical Working Group platform to deliberate on CLI issues, develop, and harmonize tools and framework for interventions; and organizing a symposium to discuss CLI issues, share lessons learnt and best practices, and create awareness and support for CLI strengthening.

Clinic-Laboratory Interface Symposium

Finally, the CDC South Africa Laboratory Program hopes that the CLI symposium will bring CLI activities and challenges to prominence and attract much needed attention and support of leaders, development agencies and partners, the wider community of implementing partners, healthcare workers, and managers at all levels of government for the strengthening of CLI and improving the quality of laboratory services.

The CDC-funded Linking for Change: Strengthening Clinic Lab Interface (CLI) Systems Symposium, hosted by SEAD, is scheduled to take place at Emperors Palace, Johannesburg, on the 11th and 12th of August 2014. The Symposium has the involvement and support of the National Department of Health (NDoH) and the National Health Laboratory Service (NHLS), as well as donors who are working to improve the CLI.

References

1. Hammerling AJ. A Review of Medical Errors in Laboratory Diagnostics and Where We Are Today. Lab Med. 2012; 43(2):41-44.
2. Hawkins R. Review article: Managing the Pre- and Post-analytical Phases of the Total Testing Process. Ann Lab Med 2012; 32:5-16
3. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in Laboratory Medicine. Clinical Chemistry2002; 48 (5): 691–8.
4. SEAD. Integrated Systems Analysis of Clinic-Laboratory Interface 2010. http://www.sead.co.za/downloads/clinic-part-a.pdf
5. Frank H. Wians HF. Clinical Laboratory Tests: Which, Why, and What Do The Results Mean? (2009) LabMedicine, 40, 105-113.