Reflection 1 Mod 5 ENCL 556 FMEA White Paper
Objective: Demonstrate understanding of Failure Mode Effects Analysis (FMEA) applied to a system design
The purpose of a failure mode process map is to identify potential failure mode and action to be taken to eliminate or reduce failure during software management and update procedure in any given healthcare organization. Lapses in software updates implementation could lead to compromise of patient information, potential HIPAA violation, huge fines and embarrassment. Failure Mode and Effect Analysis (FMEA) process map document provides knowledge of critical areas that require immediate attention and the need for continuous improvement. For hospitals, insurance companies and other healthcare provider, there is always a constant threat of law suit. Beside, federal and state regulation has strict guidelines on the collection, storage, use, and exposure of patients and patients’ data. Any impermissible use or disclosure under HIPAA Privacy Rule that compromises the security or privacy of PHI could be devastating for the organization. Any gap in software is an open window of potential compromise to patients’ data. While the quality measures discussed below may not be exhaustive, it forms the very first steps in preventing software management gaps and saving organizations from potential law suits for breach of HIPAA rules and regulations.
In this class, the relevance of Failure Mode and Effects Analysis was well covered and understood. The failures when applied to the healthcare industry is all the means and methods in which something might fail. The failures may come in the form of errors or defects, especially ones that affect the customer, and can be potential or actual. The Effects Analysis refers to the studying of the consequences of the identified failures. The failures are then prioritized according to how serious their consequences can be. Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement. FMEA is used during design to prevent failures. After design and during normal operation, it is used for control. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.
FMEA performed showed that gaps and vulnerabilities come from various failure points; from lack of timely software inventory and update, required access control and monitoring to relevant knowledge of how to use the software to protect patients and patients’ data in the healthcare industry. However a well designed and implemented quality measures can prevent or reduce the risks for any organization. Such quality measures as automatic or periodic updates of software ensures a system working as designed. It gives the organization an edge in case of a data breach as it will be seen that they have done what is humanly possible. This update need to include all computer terminals including but not limited to medical equipment’s, laptops, cell phones and other hand held devices. Equally important is access control. Up to date software is as good as the user. It is therefore important to provide software access to trusted users who have been trained to use the software. Access control should include strong passwords and periodic change of those passwords. Immediate report of access control breaches should be encouraged. Finally, knowing how the software can be used to achieve the intended, service delivery is important. This can be achieved by biennial refresher course and testing of users to align them with not just software updates but updates in new rules and regulations guiding the industry.
By scheduling automatic software updates, implementing strong access control practices and providing a robust and effective refresher course and testing course of action, the incidence of putting patients and patients; data at risk will be eliminated or reduced to the barest minimum as there will be no software management gaps.
Reflection 2 Mod 5 _ENCL 556 High Reliability Organizations Reliability and Safety (Root Cause Analysis)
Objective: Demonstrate understanding of root cause analysis applied to a failed system or device
Patient safety should be paramount in every health care organization. That means that the workflow, the systems and the environment has to be designed with patient safety in mind. The work environment has to be safe for the employees to do their job with needed concentration and for the patient to receive the needed care. System safety and easy workflow is a must for patient safety to be achieved. That is why High Reliability Organization (HROs) focus on safety. The following are the characteristics of HROs:
Deference to expertise: The openness required for the HRO to succeed depends on accurate information from every source. Therefore HROs know that expert required to avoid failure or handle failure when it occurs is the one with hands-on knowledge of the operation at the point of a failure, not the “expertise” conferred by hierarchical authority.
Commitment to resilience: The ability to embrace emerging conditions is key to their resilience. The key is not errors will not occur but that such occurrence do not disable the organization. This requires both open-minded observation and a willingness to react appropriately even under unanticipated conditions.
Sensitivity to operations: HRO(s), do not assume that the continuous outcomes will be the same all the time. They continually evaluate outcomes to determine if they are in fact serving the objectives of the organization. HRO(s), treat every operation as hands-on experiences from which lessons about the organization can be taken to further improve function in real time.
Reluctance to simply: HRO(s) are averse to complexity as they view any complexity as potential source of failure, and HROs do not apply generalized terms to describe them. In HRO(s), the occurrence of a failure is seen as an opportunity to dig deeply into the details of the system involved to find the root cause of the problem.
Preoccupation with failure: Systems in modern organizations are complicated, and they are bound to fail. HROs focus like a laser on failure by giving continuous attention to anomalies that could be symptomatic of larger problems. The thought process is that basic insight here is that big problems don’t emerge fully formed in an instant. They are almost always preceded by smaller problems or anomalies, or evidence that would point to the big problem if it were given proper attention. Therefore they look deeper into every incident to find underlying causes by performing a root cause analysis (RCA) as often. Root Cause Analysis is the process of identifying the fundamental cause of problems or events and an approach for responding to them. RCA is based on the idea that prevention is better than cure. And HROs have leveraged that adage for better patient outcome and an enviable bottom line.
This program provided a lot of managerial knowledge and tools for the health care industry among them are high reliability principles and root cause analysis.
Reflection 2-Mod 3_ENCL 500 Proposed New Medical Device
Objective: Demonstrate the use electronic health records (EHR)
When the Department of Veteran Affairs signed a $10 billion contract with Cerner, one of the primary goals was to enable data sharing between the VA and the Department of Defense (DOD). The intent was to provide a seamless care for military service members as they transition from active service to veteran status and to establish one single record as it follows service members from enlistment to military service and then as they transition to veteran status. But no one reckoned with interoperability. According to testimony from VA officials, the plan to have interoperability between the two agencies faces challenges due to laws and regulations over data governance. It was discovered that veterans who get care at VA and DOD healthcare facilities would not be able to get their entire health record once both agencies transition to a Cerner electronic health record (EHR).
The summary is that between laws, regulations and data ownership policies, patient information between these two agencies of the same Department cannot be a single data available to both agencies and the patient. In Neehr Perfect EHR, data entry in intake forms differentiate between structured and non-structured fields. Some queries can also be challenging depending on the field that the information is contained. All these is to say that the UTAUT needs to do a better of harmonizing medical device data collection, storage, transfer and usage across similar interface and users.
With that, new medical devices like MedInformatics Apps will generate, collect, collate and transfer data among similarly interfaced devices. Besides, it will be easier to develop Apps that can facilitate interoperability among differing systems. Apps that could solve the VA_DOD single data problem at a relatively cheaper cost.
Objective: Demonstrate understanding of Failure Mode Effects Analysis (FMEA) applied to a system design
The purpose of a failure mode process map is to identify potential failure mode and action to be taken to eliminate or reduce failure during software management and update procedure in any given healthcare organization. Lapses in software updates implementation could lead to compromise of patient information, potential HIPAA violation, huge fines and embarrassment. Failure Mode and Effect Analysis (FMEA) process map document provides knowledge of critical areas that require immediate attention and the need for continuous improvement. For hospitals, insurance companies and other healthcare provider, there is always a constant threat of law suit. Beside, federal and state regulation has strict guidelines on the collection, storage, use, and exposure of patients and patients’ data. Any impermissible use or disclosure under HIPAA Privacy Rule that compromises the security or privacy of PHI could be devastating for the organization. Any gap in software is an open window of potential compromise to patients’ data. While the quality measures discussed below may not be exhaustive, it forms the very first steps in preventing software management gaps and saving organizations from potential law suits for breach of HIPAA rules and regulations.
In this class, the relevance of Failure Mode and Effects Analysis was well covered and understood. The failures when applied to the healthcare industry is all the means and methods in which something might fail. The failures may come in the form of errors or defects, especially ones that affect the customer, and can be potential or actual. The Effects Analysis refers to the studying of the consequences of the identified failures. The failures are then prioritized according to how serious their consequences can be. Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement. FMEA is used during design to prevent failures. After design and during normal operation, it is used for control. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.
FMEA performed showed that gaps and vulnerabilities come from various failure points; from lack of timely software inventory and update, required access control and monitoring to relevant knowledge of how to use the software to protect patients and patients’ data in the healthcare industry. However a well designed and implemented quality measures can prevent or reduce the risks for any organization. Such quality measures as automatic or periodic updates of software ensures a system working as designed. It gives the organization an edge in case of a data breach as it will be seen that they have done what is humanly possible. This update need to include all computer terminals including but not limited to medical equipment’s, laptops, cell phones and other hand held devices. Equally important is access control. Up to date software is as good as the user. It is therefore important to provide software access to trusted users who have been trained to use the software. Access control should include strong passwords and periodic change of those passwords. Immediate report of access control breaches should be encouraged. Finally, knowing how the software can be used to achieve the intended, service delivery is important. This can be achieved by biennial refresher course and testing of users to align them with not just software updates but updates in new rules and regulations guiding the industry.
By scheduling automatic software updates, implementing strong access control practices and providing a robust and effective refresher course and testing course of action, the incidence of putting patients and patients; data at risk will be eliminated or reduced to the barest minimum as there will be no software management gaps.
Reflection 2 Mod 5 _ENCL 556 High Reliability Organizations Reliability and Safety (Root Cause Analysis)
Objective: Demonstrate understanding of root cause analysis applied to a failed system or device
Patient safety should be paramount in every health care organization. That means that the workflow, the systems and the environment has to be designed with patient safety in mind. The work environment has to be safe for the employees to do their job with needed concentration and for the patient to receive the needed care. System safety and easy workflow is a must for patient safety to be achieved. That is why High Reliability Organization (HROs) focus on safety. The following are the characteristics of HROs:
Deference to expertise: The openness required for the HRO to succeed depends on accurate information from every source. Therefore HROs know that expert required to avoid failure or handle failure when it occurs is the one with hands-on knowledge of the operation at the point of a failure, not the “expertise” conferred by hierarchical authority.
Commitment to resilience: The ability to embrace emerging conditions is key to their resilience. The key is not errors will not occur but that such occurrence do not disable the organization. This requires both open-minded observation and a willingness to react appropriately even under unanticipated conditions.
Sensitivity to operations: HRO(s), do not assume that the continuous outcomes will be the same all the time. They continually evaluate outcomes to determine if they are in fact serving the objectives of the organization. HRO(s), treat every operation as hands-on experiences from which lessons about the organization can be taken to further improve function in real time.
Reluctance to simply: HRO(s) are averse to complexity as they view any complexity as potential source of failure, and HROs do not apply generalized terms to describe them. In HRO(s), the occurrence of a failure is seen as an opportunity to dig deeply into the details of the system involved to find the root cause of the problem.
Preoccupation with failure: Systems in modern organizations are complicated, and they are bound to fail. HROs focus like a laser on failure by giving continuous attention to anomalies that could be symptomatic of larger problems. The thought process is that basic insight here is that big problems don’t emerge fully formed in an instant. They are almost always preceded by smaller problems or anomalies, or evidence that would point to the big problem if it were given proper attention. Therefore they look deeper into every incident to find underlying causes by performing a root cause analysis (RCA) as often. Root Cause Analysis is the process of identifying the fundamental cause of problems or events and an approach for responding to them. RCA is based on the idea that prevention is better than cure. And HROs have leveraged that adage for better patient outcome and an enviable bottom line.
This program provided a lot of managerial knowledge and tools for the health care industry among them are high reliability principles and root cause analysis.
Reflection 2-Mod 3_ENCL 500 Proposed New Medical Device
Objective: Demonstrate the use electronic health records (EHR)
When the Department of Veteran Affairs signed a $10 billion contract with Cerner, one of the primary goals was to enable data sharing between the VA and the Department of Defense (DOD). The intent was to provide a seamless care for military service members as they transition from active service to veteran status and to establish one single record as it follows service members from enlistment to military service and then as they transition to veteran status. But no one reckoned with interoperability. According to testimony from VA officials, the plan to have interoperability between the two agencies faces challenges due to laws and regulations over data governance. It was discovered that veterans who get care at VA and DOD healthcare facilities would not be able to get their entire health record once both agencies transition to a Cerner electronic health record (EHR).
The summary is that between laws, regulations and data ownership policies, patient information between these two agencies of the same Department cannot be a single data available to both agencies and the patient. In Neehr Perfect EHR, data entry in intake forms differentiate between structured and non-structured fields. Some queries can also be challenging depending on the field that the information is contained. All these is to say that the UTAUT needs to do a better of harmonizing medical device data collection, storage, transfer and usage across similar interface and users.
With that, new medical devices like MedInformatics Apps will generate, collect, collate and transfer data among similarly interfaced devices. Besides, it will be easier to develop Apps that can facilitate interoperability among differing systems. Apps that could solve the VA_DOD single data problem at a relatively cheaper cost.

artifact_1_mod_5_encl_556_fmea_white_paper.docx | |
File Size: | 88 kb |
File Type: | docx |

artifact_2_mod_5_encl_556_high_reliability_organization.docx | |
File Size: | 21 kb |
File Type: | docx |

artifact_3_mod_5__encl_500_proposed_new_medical_device.ppsx | |
File Size: | 2521 kb |
File Type: | ppsx |