Implementation of an Aseptic Service for Radiolabelling of Autologous Blood Cells at the Department of Nuclear Medicine, Dr George Mukhari Hospital

Abstract

Introduction: The Department of Nuclear Medicine at Dr George Mukhari Hospital (DGMH) received a biological safety cabinet (Laminar airflow hood - LAF) as a donation from the International Atomic Energy Agency (IAEA) in 2007, for the specific purpose of preparing radiolabelled blood cells. The laminar airflow hood was installed but has never been commissioned for use. Radiolabelled white blood cells are used in a range of Nuclear Medicine applications related to infection and pyrexia of unknown origin. Correct handling of the blood is essential for both patient and operator safety. A laminar airflow procedure is required for the radiolabelling of autologous blood. Therefore, there was a need to further investigate the guidelines for radiolabelling autologous blood cells with a view to commissioning the LAF and implementing a service for radiolabelling of autologous blood elements. Objectives: 1. Identify the equipment 2. Identify and development of the SOPs 3. Implement aseptic services to radiolabelling blood cells. Method: The study was conducted at the Department of Nuclear Medicine, Dr George Mukhari Hospital. The design of the study was prospective, descriptive and interventional. Data were collected through independent (objective) observation, questionnaires (subjective). In order to involve staff in the implementation of aseptic services in the respective department a focus group discussion (FGD) followed. The International Atomic Energy Agency (IAEA); Operational Guidance on Hospital Radiopharmacy and United Kingdom Radiopharmacy Group (UKRG) Guidelines were consulted to identify equipment and operational standards required. Permission to conduct the study was obtained from the Head of Department of Nuclear Medicine and Chief Executive Officer (CEO) of the Hospital. The proposal was approved by the Medunsa Campus Research and Ethics Committee (MCREC). xii Results: Premises: The room in which the LAF is situated is not in use as a clean room; hence few of the IAEA infrastructure and LAF requirements were met. Only, three aspects (18.75%) were compliant (type of LAF, lighting and dedicated equipment availability) and thirteen (81.25%) were not. For the hot lab only two (16.67%) of the fourteen items regarding structure and facilities were compliant, twelve (83.33%) were not (e.g. access, layout, cleanliness levels). The short term plan devised is to partition the area in which LAF is currently situated into a clean room and change room, seal the ceiling and windows, paint and ensure that walls, floors and surfaces are smooth and impervious in both the clean room and hot lab. The cost of alterations is (+/-) R50 000. The long term plan is to obtain funds (approximately R960 000) for the full development of the aseptic suite which will comply with local and international standards for radiolabelling of autologous blood cells recommended by ISORBE. Environment and Personnel: None of the four survey items on environment was compliant for the clean room (e.g. air not filtered, no temperature or humidity monitoring or control). Only in the hot lab was the temperature monitored. The LAF/clean room is not currently in use. In the hot lab, gowns and overshoes are not available. The plan is to have thermometers installed in both the clean room and hot lab and have log books for recording temperature. Microbial Contamination: In the Department, monitoring of microbial contamination is not performed. The IAEA recommends that surfaces, environment and equipment should be monitored for microbial contamination in an area where sterile products are handled. Staff Training & Improvement of Aseptic Services: Two staff had been trained in aseptic admixing. All eight respondents agreed that training on aseptic handling of radiopharmaceuticals is necessary. Hygiene and SOPs: Six respondents rated hygiene as satisfactory and two as not satisfactory. Despite these views, all felt that hygiene should be improved in the hot lab and that standard operating procedures (SOPs) should be developed. A group xiii was set up to develop SOPs. Four SOPs were developed - cleaning the clean room and LAF, hand washing, gowning/degowning and leukocyte radiolabelling. Radiolabelling of Autologous Blood Cells: Doctors in the Department want this service to help with the diagnosis of pyrexia of unknown origin (PUO) and infections. Therefore, they were supportive to the researcher in the project set-up the processes and facilities for radiolabelling cells. The short term plan is to train staff in radiolabelling of autologous blood cells. The long term plan is to have the facility to set-up correctly to facilitate service provision and research. Equipment: Staff mentioned that a centrifuge dedicated to the radiolabelling of blood cells should be obtained to ensure that all the procedures for labelling blood cells are followed. The short term plan is to commission the LAF (Cost: approximately R15 000 including VAT) and obtain a cooled centrifuge with sealable buckets (Cost: approximately R40 000 including VAT) for the purpose of commencing with the radiolabelling of blood cells service in the Department. Finance: Staff indicated that some of the problems in the department can be solved if they can obtain funding for infrastructure development. The short term plan is to have the budget for the upgrade of the facility included in the Departmental budget. And the long term plan is to obtain funds from the Gauteng Government for the full development of the facility Conclusion: Required standards and guidelines for radiolabelling of autologous blood cells in a radiopharmacy unit have been identified. Therefore, the upgrading process of the facility should commence and SOPs developed should be implemented. Recommendations: Necessary structural changes on the facility should be made to meet the local and international standards for radiolabelling blood products. Therefore, funds should be obtained for upgrading the facility and obtain the necessary minimum equipment for radiolabelling of autologous blood cells. It is recommended that a post for a radiopharmacist be created to increase capacity and help improve standards with regards to pharmaceutical services in the Department.