QT NEWSLETTER

April 20, 2007

{mosimage} A Matrix Model For Phlebotomy Quality Assurance
by Raymond L. Olesinski, Ph.D., MT/PBT(ASCP)SH, CLS(NCA) and Nina M. Olesinski, Ph.D., RN

The current standard references on phlebotomy provide details on quality assurance (QA) policies and quality control measures required for phlebotomy practice. A noticeable deficiency, however, is the lack of an overarching conceptual framework on phlebotomy QA that can be used to categorize what part of the phlebotomy process these measures affect and what general considerations need to be addressed for a comprehensive QA program. The guidelines and standards of various regulating and accrediting agencies are similar in this respect. We address this deficiency in this article by presenting a model for organizing phlebotomy QA data in a matrix format.


The model conceptual framework matrix was originally developed as a means to better organize program content for a continuing education program on phlebotomy QA presented by one of the authors. It stems from what would need to be considered in order to fulfill the following purpose of phlebotomy related to clinical laboratory operation: To provide blood specimens, obtained with no harm to the patient and phlebotomist, that will produce valid results from clinical laboratory testing. Based on this definition of purpose the goals of phlebotomy quality assurance are to:
1. Maximize test result validity
2. Minimize patient trauma
3. Minimize the potential for phlebotomist injury
(Note that minimizing patient trauma refers to both the physical and psychological trauma associated with
the phlebotomy procedure.)
The 4 x 4 x 3 matrix is organized into three dimensions and contains 48 cells. Each of the cells of the matrix represents a particular aspect of phlebotomy practice that contributes to a successful QA program, e.g., how training can be used to effect patient well being during the collection phase of phlebotomy. Phlebotomy practice is segmented into three phases that are analogous to the preanalytical, analytical and post analytical framework commonly used to describe clinical laboratory practice. The analogous phases are pre-collection, collection and post-collection. Pre-collection includes, but is not solely limited to, test ordering, patient preparation and training. The collection phase applies to procedures directly involved in acquiring blood specimens by various techniques. Post-collection activities encompass what occurs once the specimen has been obtained.
A second axis corresponds to the goals of phlebotomy and includes patient test management (PTM), as being. PTM is divided into identification and specimen suitability phases. Specimen suitability is defined as the degree to which a correct specimen is obtained and specimen integrity maintained during those activities that are under the control of phlebotomists. The final axis involves process considerations and equipment that are necessary to effectively accomplish quality goals. These include training, technique, QA monitoring and equipment. The framework is applied to individual tests that comprise a clinical laboratory's test menu. The information needed to fill each cell may be similar or redundant for many of the same tests, leading to an economy of effort in the development of the matrix. However, much of the information for many of the tests will be unique, either due to the nature of the test or to the specific clinical environment in which the specimens are collected.
If used to develop a phlebotomy QA program, each individual cell should be considered for a particular test. For example, personnel responsible for a phlebotomy operation would need to ask about the equipment considerations during the collection phase, when drawing a complete blood count that would maximize specimen suitability. Similarly, for the same procedure, they would need to consider what techniques (or procedures) in the post-collection phase would lead to appropriate patient test management regarding specimen identification. If each cell is considered systematically, the matrix facilitates the development of a QA program for various procedures by ensuring that no important consideration is overlooked. For QA programs, the matrix approach has three potential benefits. First, by considering each cell for each test on the menu, phlebotomists can determine if important considerations had been overlooked in the past. Second, the matrix can serve as a means of systematically examining test result validity problems that may be related to phlebotomy operation. Third, the matrix can be used as an integral component of continuous quality improvement (CQI) efforts.
Continuous quality improvement focuses on improving processes, as well as the performance of individuals on an ongoing basis. Part of the CQI process involves identifying aspects of practice where improvements need to be made. Using the data already contained in the phlebotomy QA matrix-specific aspects of practice can be readily targeted for improvement based on various criteria, e.g., the expert's knowledge of problem-prone areas, implementation of a new practice, etc. Once the aspects of practice have been targeted, specific, measurable quality indicators can be developed, and additional CQI data can be collected and analyzed. Thereafter, a specific action plan can be implemented to further improve the phlebotomy process. Evaluation of the completed CQI process may ultimately lead to the revision of the phlebotomy QA matrix by providing new information related to test collections. As this cyclical process continues, the matrix will become more individualized for a specific clinical setting.
While the matrix can be developed as a printed manual, the data entry and retrieval associated with it best suggest creation of a computerized database. Since a three- dimensional database may be difficult to visualize and use, we suggest constructing the database as a series of three, two-dimensional tables for each test. The tables would correspond to the pre-collection, collection and post- collection phases and provide information for each of the 16 cells that cross-reference the goals and the process/equipment axes. Such a computerized database could be made available institution-wide and could incorporate user-friendly search features that would allow phlebotomists and other health care personnel to rapidly retrieve valuable QA specifics on individual laboratory tests.
Additionally, authors of phlebotomy textbooks, guidelines and standards can use the matrix model to provide a consistent, all-encompassing conceptual framework within which to organize information on phlebotomy QA. Educators can also use the model as a means of organizing program content and helping students to internalize a systematic way of thinking about phlebotomy QA. In summary, the matrix approach to phlebotomy QA provides a systematic conceptual framework for organizing phlebotomy QA data and developing and improving QA programs. Based on considerations needed to effect the goals of a quality phlebotomy service, it links the phases of phlebotomy, the goals of QA related to phlebotomy and the process and equipment considerations needed to accomplish those goals. We hope that the matrix model will be adapted and tested by clinical laboratories to determine its merit in actual practice and to effect future improvements in the model.

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