Pending such evaluation, it may be desirable to implement interim remedial action. In some states, consent is required for this voluntary testing; rejection of offered testing must be documented. Staff members who do not demonstrate the requisite understand- ing and skills must receive additional training. Evaluations typically include comparisons of actual to expected results. Quality Management as an Evolving Science The principles and tools used in quality man- agement today will change as research pro- vides new knowledge of organizational behav- ior, technology provides new solutions, and the transfusion medicine and cellular thera- pies fields present new challenges. Quality indicators are used to monitor progress toward stated quality goals and objectives. Evaluating Enzyme-Treated Red Cells Method 3-12.Next
Environmental monitoring systems should be considered for laboratories that require posi- tive or negative air pressure differentials or where air filtration systems are used to control particle levels. . Unauthorized access, modification, or destruction of data and information must be prevented and confidentiality of patient and donor records main- tained. Periodic integrity checks should be conducted to ensure that critical data have not been inad- vertently modified, been lost, or become inaccessible. Platelet and Granulocyte Antigens and Antibodies 453 Brian R. Reporting and monitoring of events are essential problem identification methods for process improvement activities in a quality management system. A process flowchart gives a detailed picture of the multiple activi- ties and important decision points within that process.Next
Documents describe how processes are in- tended to work, how they interact, where they must be controlled, what their require- ments are, and how to implement them. Additional information about both approach to problem solving of define, mea- methods can be found on the website of the sure, analyze, improve, and control. Receipt and inspection records enable the facility to trace materials that have been used in a particular process and provide information for ongoing supplier qualifica- tion. Preparing and Using Phosphate Buffer Method 1-9. Establish quality goals for the project.Next
The traditional topics covered as part of discus- sions on blood utilization review and periop- erative blood recovery are augmented by detailed content on anemia management, optimization of coagulation, and a host of adjunctive therapies that can reduce the need for transfusion. They should be consulted when possible solu- tions are being considered. Develop process controls and validate the process in the operational setting. Disaster Management 97 Ruth D. International Organization for Standardiza- tion.Next
These indicators can be process based or outcome based. Chemical Categories and Howto Work Safely with Them. The structure of the or- ganization must be documented, and the roles and responsibilities for the provision of tests, products, and services must be clearly defined. Control chart A graphic tool used to determine whether the distribution of data values gener- ated by a process is stable over time. Records provide evidence that the process was performed as intended and allow assessment of product and service quality.Next
One-Stage Enzyme Procedure Method 3-13. Even low- voltage exposures can lead to serious injury. Each facility must have a policy for alter- ing or correcting records. Whole-Blood Collection and Component Processing 135 Larry J. If it is not possible to interrupt the power supply, a nonconduc- tive material, such as dry wood, should be used to pry a victim from the source of cur- rent. Damaged receptacles and faulty electrical equipment must be tagged and removed from service until they have been repaired and checked for safety.
These pro- grams should be representative of the facility processes and consistent with organizational goals, and they should reflect customer needs. In addition to providing adequate facili- ties, the organization should develop and im- plement a safety program that defines policies and procedures for safe work practices and emergency responses. Other assessments important in transfusion practice include reviews of policies for in- formed consent, indications for transfusion, releases of directed donor units, and outpa- tient or home transfusions. Possible solutions should be evaluated relative to organizational con- straints and should be narrowed down to those that are most reasonable. Portable screens and crowd-control ropes are helpful in directing traffic flow to maintain safe work ar- eas. Mobile Sites Mobile blood collection operations can pre- sent special challenges. Training should be provided to the staff responsible for the content of new or revised documents.Next
Careful consideration should be given to maintaining a controlled process and verifying the safety and quality of the resulting product or service. Personnel involved in collecting and processing the unit s are at risk of exposure to infectious agents. Archival copies of computer operating systems and applications software required to view original records should be stored in the same manner. Process improvement includes determination of root causes, implementation of corrective and preventive actions, and evaluation of the effectiveness of these actions. Records Records provide evidence that critical steps in a procedure have been performed appropri- ately and that products and services conform to specified requirements. This model centers around three fundamental processes for managing quality in any organization: planning, control, and improvement. When equipment is found to be operating outside acceptable parameters, the potential effects on the quality of products or test results must be evaluated and documented.Next
Medical laboratories — Requirements for quality and competence. The process of develop- ing corrective and preventive action plans in- volves identification of problems and their causes as well as identification and evaluation of solutions to prevent future problems. Effective job de- scriptions clearly define the qualifications and responsibilities of the positions as well as their reporting relationships. Inadequately address- ing customer concerns or failing to meet ex- pectations may result in loss of the customer. Administrative and clerical areas are generally considered low risk and not restricted. The documents developed should be re- viewed by management personnel with direct authority over the process and by quality over- sight personnel before implementation.