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Each course requires you to complete a Course Project. In this course, your project will consist...

Each course requires you to complete a Course Project. In this course, your project will consist of conducting an assessment of Evolving External Issues related to a health care organization. This health care organization may be the one you currently work for, one you have worked for in the past, or one you desire to work for (for example a hospital in your community, etc.). Your final written assessment should be between 1600 to 1700 words in length (more if you prefer), 12 point font, double-spaced; and must use APA format for both in-body citations and the reference page at the end of the paper.

The overall resource guide for your Course Project efforts will be pages 36-38 of Chapter 2 in your textbook. In particular, you will write about (assess) each of the areas where changes may impact your selected organization. This means your Course Project should address potential areas of change to your selected health care organization in the following areas:

  • Legislative/Political Changes
  • Economic Changes
  • Social/Demographic Changes
  • Technological Changes
  • Competitive Changes

In visualizing what your final Course Project document will contain, it should have a section for each of the five change areas above specific to your organization; along with an Introduction and Conclusion section. How you structure the content using this format is totally up to you!

The individual Course Project Assignments will all contribute to your final product so there is no wasted effort!

For Lesson 1, your goal is to write the Introduction section, describing the health care organization you are using as the basis for exploring evolving external issues. In addition, you will also write the Legislative/Political Changes section, identifying any changes in this category that may impact your organization. Be sure to include your APA citations and edit your writing before submitting these first two parts of your Course Project to your instructor for review and comment.

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External assessment is increasingly used worldwide to regulate, improve and market health care providers, especially hospitals.

Most countries have statutory inspectorates to monitor compliance of hospitals with published regulations required for licensing. More specialized versions typically relate to fire, hygiene, radiation, medical devices, and medicines but some countries include infection control and blood transfusions. Standards are in the public domain as legal regulations and are thus difficult to update. They address the minimal legal requirements for a health care organization to operate and care for patients, in terms of structure and capacity to protect basic public health and safety; they do not usually address clinical process or hospital performance. In many countries, institutional licenses are issued before a new institution opens and there is no systematic or regular follow up; in some, operating licenses are reissued in return for payment of a fee with minimal or no inspection. Such assessments by local government agents may be inconsistent nationally and do not provide a credible independent check on the public sector.

*International Organization for Standardization

The International Organization for Standardization (ISO)8 developed a series of standards (ISO 9000) which were originally designed for the manufacturing industry (eg medicines, medical devices) but which has been used to assess quality systems in specific aspects of health services and in whole hospitals and clinics. Hospitals (or, more commonly, parts of them) are assessed by independent auditors who are themselves regulated by a national ‘accreditation’ agency. Performance is measured in terms of compliance with the ISO standard.

Certification is widely available from independent certificated auditors and is recognized in many other service and manufacturing industries, and across national borders. But the current ISO 9000 standards relate more to administrative procedures than to hospital performance, and the terminology is difficult to relate to health care, leading to varying interpretations between national agencies. The audit process tests compliance with standards and is not intended in itself for organizational development.

Even if ISO standards are voluntary – the fact that they are developed in response to market demands, and are based on consensus among them. ISO takes account of both evolving technology and evolving interests by requiring a review of its standards at least every five years to decide whether they should be maintained, updated or withdrawn. In this way, ISO standards retain their position as the state of the art, as agreed by an international cross-section of experts in the field.

ISO develops only those standards for which there is a market requirement. Experts on loan from the industrial, technical and business sections, which have asked for the standards, carry out the work and subsequently put them to use. Others with relevant knowledge, such as representatives of government agencies, consumer organizations, academia, and testing laboratories may join these experts.ISO standards have played important role in providing benefits to the various strata of the society. The benefits, which can accrue to the different strata, are given in the following paragraphs: For business, the widespread adoption of International Standards means that suppliers can base the development of their products and services can base the development of their sectors. This, in turn, means that businesses using International Standards are increasingly free to compete in many markets around the world. For customers, the worldwide compatibility of technology, which is achieved when products and services are based on International Standards, brings them an increasingly wide choice of offers, and they also benefit from the effects of competition among suppliers. For governments, International Standards provide the technological and scientific bases underpinning health, safety, and environmental legislation. For trade officials negotiating the emergence of regional and global markets, International Standards create “a level playing field” for all competitors on those markets. The existence of divergent national or regional standards can create technical barriers to trade, even when there is political agreement to do away with restrictive import quotas and the like. International Standards are the technical means by which political trade agreements can be put into practice. For developing countries, International standards that represent an International consensus on the state of the art constitute an important source of technological know-how. By defining the characteristics that product will be expected to meet on export markets, International Standards give developing countries a basis for making the right decisions when investing their scarce resources and thus avoid squandering them. For consumers, conformity of products and services to International Standards provides assurance to quality, safety, and reliability.

The standard was primarily intended for situations where customers and suppliers were in a contractual relationship. It was not intended for use when there was no contractual relationship. Even in contractual situations, demonstration of capability is often only necessary when the customer cannot verify the quality of the products or service after delivery. It is clear that customers need confidence in the quality of products supplied and would require some evidence that addressed the need. ISO 9000 was a neat solution to this problem as it embodied most of the requirements needed to obtain an assurance of quality. Any additional requirement could be put into the contract. ISO 9000:2000 is a series of three International Standards for Quality Management Systems. They specify requirements and recommendations from the design and assessment of management systems. ISO 9000 is not a product standard. The purpose of the standards is to assist organizations of all types to implement and operate effective quality management systems.

The purpose of ISO 9000 is to provide an appreciation of the fundamental principles of QMS and an explanation of terminology used in the standard. Although they are not requirements, the context and interpretation of the requirements will not be understood without the appreciation of the concepts that underpin the requirements.

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