Electronic Medical Records

Assessment/Implementation Plan Assignment for the OLINDA/EXM personal computer

OLINDA/EXM stands for Organ Level Internal Dose Assessment/Exponential Modeling and is used in calculating radiation doses to dissimilar body organs from systemically administered radiopharmaceuticals. It executes regression analysis on user-supplied biokinetic data in order to support such calculations. The OLINDA/EXM version 1.0 personal computer code was developed in order to replace the extensively used MIRDOSE3.1 code (Stabin, Sparks & Crowe, 2005). The purpose of this paper is to prepare an implementation plan for use of this device/system in a patient care setting.

The system commonly runs on Windows-XP or Windows-2000 based personal computers, with at least 256 MB RAM and 100 MB free space on the hard disk. When obtaining the software, a comprehensive instruction manual which includes implementation tests is supplied to the users by the vendors. The implementation tests typically illustrate a sequence of sample problems which could be run to make sure that the software is installed correctly and in an approved manner. Apart from the comprehensive instruction manual that is provided together with the code/software, some on-screen help is also supplied. Moreover, active support regarding the use of the software is also provided through fax, email, phone or regular mail (Stabin, Sparks & Crowe, 2005).

Description of the setting and those who will use the device or system

The OLINDA/EXM software application is planned to be deployed to an oncology or cancer clinic and those who will use it are nuclear medicine physicians or medical professionals within the radiopharmaceutical industry. OLINDA/EXM code will be used in performing dose calculations as well as kinetic modeling for radiopharmaceuticals (Khalil, 2011). OLINDA will calculate radiation doses to dissimilar body organs from radiopharmaceuticals that have been administered systemically, and will perform regression analysis on the user supplied biokinetic data in order to support such calculations for nuclear medicine drugs. According to the Center for Technology Transfer and Commercialization (CTTC), these calculations will be used by the nuclear medicine physicians in performing risk/benefit assessments of the use of such pharmaceuticals in therapeutic and diagnostic applications in nuclear medicine (2012).

OLINDA will be used to perform internal dose calculations chiefly for radiopharmaceuticals, with the use of RADAR technique of dose calculations as well as RADAR dose factors, while the EXM module will be used to fit kinetic data to the sums of exponential functions (Khalil, 2011). RADAR simply refers to the RAdiation Dose Assessment Resource – a working group which maintains resources for external and internal dose calculations. OLINDA executes the dose factors from the website of RADAR in a code which allows users to input kinetic data for radiopharmaceuticals (CTTC, 2012).
Description of the patient/client population to be served

Patients to be served include those suffering from cancer such as prostate cancer and thyroid cancer, and the OLINDA/EXM personal computer code will be used to perform dose calculations and kinetic modeling for radiopharmaceuticals (Khalil, 2011).

Timeline for implementing the system

Stabin, Sparks and Crowe (2005) pointed out that implementation of the system in clinical practice is a linear process with a clearly defined starting point, goals as well as readily identifiable phases. Successfully implementing OLINDA/EXM personal computer will involve more than just selecting the appropriate vendor and signing the contract. The process of implementing the system will start with specifically defined goals and a project implementation team identified. The implementation plan will address everything including workflow, software and hardware selection, installation to user/staff training. Here is the process the clinic will go through as they adopt the new system.

March 2013: Defining goals and identifying the project implementation team
April 2013: Begin evaluating the different versions of OLINDA/EXM personal computers
May 2013: Choose the relevant OLINDA/EXM personal computer software and acquire the appropriate hardware
June 2013: Sign contract with OLINDA/EXM personal computer vendor
August 2013: Conduct initial basic skills assessment staff training
October 2013: Install the system to the clinic for use by nuclear medicine physicians and conduct application-specific staff training.

Plan for staff training-include time required, content outline for training and identification of who should conduct the training

The staff training will involve two stages – initial basic skills assessment and the application-specific training – and they will be performed for two months and one week respectively before starting to use the system. The initial basic skills assessment training will last for one week and the content outline will be the basics/fundamentals or overview of OLINDA/EXM personal computer. This initial training will not cover the details of the software. The second staff training will also last one week and its content will cover OLINDA/EXM personal computer in detail including how to use it effectively. Questions from the trainees will be answered adequately to ensure they have proper understanding of the software. The training will be carried out by personnel from the vendor who has adequate knowledge of OLINDA/EXM personal computer. Moreover, the vendor’s trainer will stay on site during installation and two weeks after installation in order to answer questions and deal with problems that may arise.

Plan for evaluation of the effectiveness of the device or system

System evaluation plan will involve the following essential steps; the first one is determining whether the system meets its intended goal from the viewpoint of the user who will interact with the system on a regular basis. In this step, the system will be compared to the goals identified prior to implementing the system in order to determine whether the intended goals have been attained. The second step involves evaluating the ease of use and user satisfaction. In general, the system should be easy for the users to use. Third step will be about economic effectiveness, and this will require identifying the costs and benefits of the system and properly evaluating them. Benefits derived from the system will be expected to outweigh the overall costs of acquisition and implementation (Khalil, 2011).
Possible disruption or impact of implementation on usual work of the patient care setting

There will be a possible disruption or impact of system implementation with regard to the usual work of the patient care setting. This will arise largely because of the physician meetings that will be called to address any issues or problems regarding the system. Moreover, they will also continue to meet occasionally to discuss OLINDA/EXM personal computer issues and problems. As such, these meetings will likely have an impact on the usual work of the patient care setting.

Conclusion

The wide testing of OLINDA/EXM software program, which was based on comparison with literature-established dose calculations and with the extensively tested and accepted MIRDOSE3.1 code ought to give users confidence with regard to its output. With an effective plan, OLINDA/EXM software should be particularly easy for MIRDOSE users to accept and for new users to understand and adopt. It would be helpful in automating and standardizing internal dose calculations, evaluating doses in clinical trials with radiopharmaceuticals, teaching, performing theoretic calculations for the existing pharmaceuticals, and other purposes. Implementing the OLINDA/EXM personal computer in clinical practice is a daunting task requiring good planning, effective leadership and supportive employees. The most immediate benefit of the software will be its use in calculating radiation doses to dissimilar body organs from systemically administered radiopharmaceuticals.

Reference

Center for Technology Transfer and Commercialization. (2012). OLINDA/EXM Radiation Dose Assessment Software Application (FDA Approved). Nashville, TN: Vanderbilt University.

Khalil, M. (2011). Basic Sciences of Nuclear Medicine. San Francisco, CA: Springer

Stabin, M., Sparks, R., & Crowe, E. (2005). OLINDA/EXM: The Second-generation Personal Computer for Internal Dose Assessment in Nuclear Medicine. Retrieved from http://lib.bioinfo.pl/paper:15937315

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