Integrating Theory and Research: Needs Assessment for the Patton - Fuller Community Hospital’s Compliance to Safe Medical Devices Act of 1990 (and its Amendments in 1992)
Cliff Musimenta
University of Phoenix
Integrating Theory and Research: Needs Assessment for the Patton - Fuller Community Hospital’s Compliance to Safe Medical Devices Act of 1990 (and its Amendments in 1992) The Safe Medical Devices Act of 1990 (P.L. 101-629, Section 12, 104 Stat. 4523, 1990) was signed by President Bush on 28 November 1990. According to Samuel (1990), the law entailed seventeen timetabled sets of new regulations that can be grouped into the following four categories: premarket approval; post-market surveillance; penalties; and miscellaneous. According to Merrill (1994, p. 47), the Food and Drug Administration (FDA) “agency was given power to prescribe good manufacturing practices (GMP) requirements for devices, to ban worthless or dangerous products administratively, and to require notification, replacement, and/or refund by makers of defective products.” According to Swayze & Rich (2012) “a medical device is, simply defined, any item used to diagnose, treat, or prevent disease, injury, or any other condition that is not a drug, biologic, or food” (para. 1).

In any health organizational set up, creating patient safety requires that the organization establishes a safe health environment that eliminates/minimizes all unintentional injury to ensure patient wellbeing. This set up requires the institution to operate an institution whose processes and methods prohibit errors or drastically reduces the possibility of inflicting serious damage whenever such arise. The U.S. FDA is in charge of regulations that pertain to medical device products meant “for utilization in the diagnosis, treatment, mitigation, cure, or deterrence of infections intended to influence the composition or any role of the human body or other animals” (Scott, Donnell, & Burkett, 2009, p. 5).

Patton-Fuller Community Hospital (PFCH) is a non-for-profit healthcare organization located in the city of Kelsey. Since 1975, PFCH has been providing a range of services and facilities to the city’s surrounding communities. Some of the specialized services PFCH provides include: emergency medical care; surgery; labor and delivery; physical therapy; and radiology for adults and children. PFHC was one of the first hospitals in Kelsey and among its goals are to provide health programs that support the health and welfare of the population in their local community. PFCH’s mission, vision, and goals are:

To be the healthcare organization of choice for patients, healthcare professionals, and physicians; to provide quality award winning healthcare services to the community by effectively treating diseases and injuries, providing early intervention, and preventive care; and ensuring their staff embraces creativity, integrity, quality, service, teamwork and independence (UOP, 2013).

This paper will analyze the reasons for PFCH's existence and organizational structure. A needs assessment and proposal for utilizing MedSun funds to improve medical device policies, procedures, and processes will be presented. Use of primary and secondary sources of information related to medical devices and methods to improve adverse event reporting and patient safety will be incorporated in the analysis. Also, ways in which this project supports short-term goals and sustains long-term objectives will be discussed. Lastly, a timeline for project completion will be suggested, and a course of action pertaining to collaborative interactions among the key stakeholders to facilitate the organization's success will be recommended.

Needs Assessment and Proposal

PFCH is partnering with the FDA's MedSun Project to develop patient wellbeing by highlighting anomalies associated with medical health care devices in order to ensure compliance with reporting requirements. A MedSun grant of $25,000 is available to PFCH’s funding of research designed to improve medical device safety in clinical and operational processes. A needs assessment and proposal is needed before the MedSun funds can be utilized. Specifically, medical device policies, procedures, and processes must be improved in order for the main objective of improving health services to be achieved. PFCH’s program and performance goals must align with its related budget initiatives and project strategic goals they support, (including plans covering all department strategic goals). The program must also outline how it will be aligned with the existing partnership with States, localities, and the private sector, to meet the health and human service needs of the patients.

Collaboration and partnership are important to PFCH’s success in implementing this project. PFCH is currently collaborating with the FDA on the HIV infections through strengthening capacity nationwide aimed at developing and implementing effective prevention strategies and diseases through immunization. PFCH plans to continue such arrangements and partnerships. Through this project, PFCH will continue to respond to emergencies through state community health organizations as outlined in the state strategic guidelines. The PFCH-FDA partnership will also be in support of nation’s biographical surveillance efforts designed for early potential disease detection. In addition, PFCH-FDA relationship will contribute to better supervision of reports of unpleasant events and other inconveniences with health care devices. Health experts and the public will be alerted certifying appropriate use of devices and the health and wellbeing of patients becomes necessary. Organizational Structure, Policies, Procedures, and other Capabilities An organizational structure outlines the roles and reporting structure between employees at different positions in an organization. Organizational structures facilitate organizations to work cohesively as social entities and, thereby, helping the organization to realize and reach its goals. Five basic primary organizational structures exist: (1) functional, (2) geographic, (3) divisional, (4) matrix, and (5) product team (Pierce-Robinson, 2004). A functional structure exists in an organization when a group of people hold similar positions, perform similar sets of tasks, and use the similar skills. A functional structure of organization best suits PFCH since the hospital requires well-defined skills focused on areas of specializations organized around clinical and administrative function. Efficiency at PFCH is of great importance and it is measured and ensured in different clinical functions: radiology, pharmacy, laboratories, emergency rooms and operating rooms, wards, intensive care units, and doctors’ personnel offices and outpatient examining rooms. Other support functional areas IT, admitting/discharge, HR, facilities, hospital senior management and finance (Patton-Fuller Community Hospital, 2013). PFCH will enjoy the advantage of a functional structure but it will also have to deal with the disadvantage of its promotion of narrow specialization and functional rivalry/conflict. Therefore PHCH’s top management will have to insure that programs to enhance team planning and coordination are implemented (Pierce-Robinson, 2004). PFCH’s safety standards and guidelines must remain high. “Emergency management for healthcare facilities involves elements of alleviation, attentiveness, reaction, and resurgence. The objectives in order to obtain these goals should consider things such as suitability and sufficiency of physical facilities, organizational structures, personnel, and communication systems” (UOP, 2009). PFCH must develop a detailed sequence of steps and objectives taken to measure milestones and measures of progress, responsibilities, and assignments. A time line of events and an effective action plan that encourages feedback and open communication with internal and external stakeholders will be extremely necessary. PFCH will need to consider horizontal collaboration or integration - which is the "acquisition or merger of competing businesses" (Pearce, 2004), and vertical collaboration or integration which is the "acquisition or merger of suppliers or customer businesses" (Pearce, 2004). Human capital acquisition and retention management for PFCH especially of doctors and physicians with specialized skills and expertise will enhance the public image in the community. PFCH’s key stakeholders include the employees, patients, visitors, investors, the Board of Directors, and the community. Stakeholder relations and information management will need to be enhanced. Smallwood, Sweetman, & Ulrich (2007) stated that: Employees want to work in a place where they can meet their personal needs and wants. Leaders who create job assignments, work environments, and visions help employees be both competent and committed to their work." Patients want to know that they are receiving the best care possible and be able to trust the care providers. Visitors want to know their loved ones are receiving the best care and that they can trust caretakers. All stakeholders have their demands/needs and such needs may at times be in conflict with one another (p. 49)
Project Support for Short-Term Goals and Sustainability of Long-Term Objectives PFCH’s goals are to provide quality customer care and services to all its patients and by meeting the needs and expectations of key stakeholders. Due to the nature of today’s cost structures, efficient care management is of absolute essence. Therefore PFCH must implement people-centered mechanisms that must encourage, motivate and control key personnel towards the accomplishment of long-term organizational goals and objectives. Fortunately, the FDA works with its stakeholders in a structural effort to identify and prevent medication errors that will assist PFCH in the implementation of this project. The FDA recommends the following steps be implemented by the organization prior to applying for the any grant: develop a general list of candidate cases for collaborative analysis and intervention; collaborate with Federal partners to develop population-based national estimates of preventable harm from medications, categorized by drug, drug classes, and therapeutic situations; open a public docket to receive suggestions and comments related to this report, risk management issues, and proposed candidate cases; hold a series of meetings to gather broad public feedback as the candidate list is being developed; and based on the public contribution just outlined and the best available population-based data, work with interested partners to select specific candidate cases for analysis, intervention proposals, and evaluation metrics (FDA, 2014).
Timeline for Project Completion A 12 months period of time is recommended for this project duration. Parceled into progressive steps, each step will be designed to ensure that proper policies, procedures and processes are in place to assist PFCH meeting regulatory bodies’ standards. Embedded in the steps will be systematic measurement and accountability mechanisms involving strong leadership. PFCH’s suggested short and long term goal-oriented activities should include: • Establish a list of candidate cases to be reviewed for analysis and intervention by collaborators and stakeholders.

• Discuss policies, rules, and regulations. Perform a Strength, Weaknesses, Opportunities, and Threats (SWOT) analysis within first two months of project

• Create an inventory of preventable medication list based on national standards encompassing medication errors that are common globally and ways that measures have been put in place to prevent them (Two months after initial implementation)

• With partners, select specific interventions and measures for the list of cases that have been established. Develop specific interventions and measures for the list of cases that have been selected. (Two months after collaboration with federal partners)

• Measure the developed interventions that have taken place over the past 6-8 month timeframe. Ensure that interventions show the impact of the various interventions and can be utilized to develop tool for measuring the effectiveness of medication interventions.

This process should be ongoing (FDA, 2014).

Continued professional education must be built in the entire project in order for PFCH to effectively implement the grant’s goals and objectives. The suggested total time needed to implement the grant will be 12 months from the date of the grant’s inception.

Conclusion PFCH’s records must be reviewed and areas where project funds can be used to improve medical policies, procedures and practices to assist with medication errors and fiscal sustainability be identified. PFCH has a strong presence in the community it serves. It’s internal processes and management team appears strong. PFCH should use the Safe Use Initiative that will allow it to self-assess its areas of strengths and weaknesses with improving patient safety. This methodology will also allow them to collaborate with various stakeholders in an effort to improve their overall revenue sources and decrease their medication errors. The overall goal would be to increase the quality of services that they provide and ultimately gain the trust and increase the customer based of the organization as a whole. These safety measures will improve healthcare outcomes throughout the community.

References
Merrill, R. A. (1994). Regulation of drugs and devices: An evolution. Health Affairs, 13(3), 47- 69.
P.L. 101-629, Section 12, 104 Stat. 4523 (1990).
Pearce II, John A. (2004). Strategic Management: Formulation, Implementation, and Control. 9th Ed. Chapter 6, p 209.
Pierce-Robinson (2004). Strategic Management: Implementing Strategy, Structure, Leadership and Culture, Ch. 10, p 359.
Samuel, Jr., F, E. (1990). Safe medical devices act of 1990. Health Affairs, 10(1), 1991: 192-195. Doi: 10.1377/hlthaff.10.1.192
Scott, F., McDonnell, W., & Burkett, M. (2009). Designing medical devices to improve patient outcomes. AMR Research, Inc.
Smallwood, N., Sweetman, K., & Ulrich, D. (2007). A leader's five key stakeholders. Retrieved February 16, 2014 from: http://blogs.harvardbusiness.org/cs/2007/11/a_leaders_five_key_stakeholder.html
Swayze, Sonia C,R.N., M.A., & Rich, Suzanne E, RN,M.A., C.T. (2012). Promoting safe use of medical devices. Online Journal of Issues in Nursing, 17(1), 11-9. Retrieved from http://search.proquest.com/docview/1079889126?accountid=458
UOP (2013). Patton-Fuller Community Hospital. Retrieved on February 16, 2014 from: https://ecampus.phoenix.edu/secure/aapd/CIST/VOP/Healthcare/PFCH/employeefiles.asp?ashley