Starting in 1999, numerous organizations have published reports that highlight the harm brought to patients by health care organizations (Ciesielski & Fraser, 2016).  These reports, the increased complexity of health care environment, and the inclusion of medical software as a critical component in health care delivery had been the triggering factors for the promotion of patient safety, quality improvement and regulations.  Quality improvement methods in health care organizations seek to focus on intervention that will benefit most the patient and improvement of health care delivery processes (Carlisle & Blanchard, 2016).  Additionally, as part of these process improvement, health care organization must aim their efforts at the management and regulation of software and hardware for medical use in order to avoid medical errors that have their origin in faulty software and hardware.

Artifact 1: 542 Post Implementation Evaluation

• Demonstrates the articulation of tools that evaluate human and technology systems
• Demonstrates the articulation of methods for design of quality programs or performance improvement programs as applied to implementation of electronic health record systems

This artifact evaluates the implementation process of an electronic health record (EHR) in a mock health care organization.  This evaluation is applied three to four week after the go-live date on the EHR system implementation with the goal of identifying the areas that can be improved.  Additionally, this process helps to identify any technical and knowledge gaps that can affect the use of the EHR system and propose customized training to leverage these issues.

Artifact 2: 544 Definitions

• Demonstrates the knowledge on Privacy and security of Protected Health Information (PHI)

This artifacts contains the interpretation of concepts that are related to privacy and security on health care organizations.  The objective of this artifact is to demonstrate the understanding and identify the relevant regulations that protect health care information and privacy security.  Include definitions include the following: Health Insurance Portability and Accountability Act, Covered Entity, Business Associate, Protected Health Information, Privacy Rule, Breach, Minimum Necessary Access, Administrative Safeguards, and, Physical Safeguards.

​Artifact 3: 556 Quality Measures for Monitoring Software for IoT Devices

• Demonstrates the knowledge of hardware
• Demonstrates the articulation of tools that evaluate human and technology systems

This artifacts includes the identification of proposed quality measures needed to monitor IoT devices used for medical applications.  The proposed quality measurements have the purpose of assisting device manufactures and firmware developers in the identification of the Mean Time Between Failures and Mean Time to Recovery/Repair.  Additionally, they aim to assist in the assessment of reliability and availability of a medical device and its software.
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References
Carlisle, A., & Blanchard, M. (2016). Introduction to Quality Improvement. In E. Fondahn, M. Lane, & A. Vannucci (Eds.), The Washington Manual of Patient Safety and Quality Improvement (Philadelphia, pp. 10–22). Wolters Kluwer.
Ciesielski, T., & Fraser, V. J. (2016). Introduction to Patient Safety and Quality Improvement. In E. Fondahn, M. Lane, & A. Vannucci (Eds.), The Washington Manual of Patient Safety and Quality Improvement (pp. 2–10). Philadelphia: Wolters Kluwer.
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Artifact 1:

postimplementationevaluation.doc
File Size:	135 kb
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Artifact 2:

definitions.docx
File Size:	40 kb
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Artifact 3:

fmea.qualitymeasure.docx
File Size:	43 kb
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