ATS Pulmonary Function Laboratory Manual

chapter  3

3.

Organizational structure 3.1.

The organizational structure of the laboratory depends on the size of the operation, but should in- clude a qualified medical director and well-trained technical staff (1). Larger operations might also require a technical director, manager, and/or supervisor in addition to the testing staff. In addition, there may be computer support staff, administrative assistants (transcriptionist), and/or bioengineers who provide support to laboratory operations. Quality Systems in Pulmonary Function Laboratories The Clinical and Laboratory Standards Institute (CLSI) published an approved guideline outlining a model for quality systems in healthcare in 1999 that was last updated and retitled Quality Management System: A Model for Laboratory Services (QMS01-A4) in 2011 (2). Subsequently, in 2002 and updated in 2006, a guideline was pub- lished applying the quality management system to respiratory care, titled Application of a Quality Management Sys- tem Model for Respiratory Services (QMS07-A2) (3). Detailed discussion and implementation steps for pulmonary diagnostics may be found in this document and other resources (4). The model outlines twelve essential items or quality-system essentials (QSEs) and the path of workflow for pulmonary diagnostics ( see Appendix 3.1). Specific recommendations for development of a documentation system are also included. The twelve QSEs should be incor- porated into the daily operations. A quality manual includes the PF laboratory’s intent to fulfill each of these QSEs as provided in the following example. 1. QSE: Documents and Records: All documents and records are maintained according to standard operating procedures and accreditation or regulatory bodies. 2. QSE: Organization: Each PF laboratory-testing site is committed to providing quality patient care and test performance according to published standards and guidelines. 3. QSE: Equipment: Procedures address selection and installation of equipment. An installation manual is maintained for the life of the equipment. 4. QSE: Process Management: The standard operating procedures in this manual address all test performance issues across the pulmonary diagnostic path of workflow. The laboratory will participate in internal and external assessments. 5. QSE: Personnel: Personnel issues are addressed in the standard operating procedures. All employees are required to complete an approved orientation and training program. In addition, all employees are re- quired to maintain documentation of their training and education. 6. QSE: Purchasing and Inventory: A system to maintain adequate supplies at an acceptable functional level will be maintained and monitored. 7. QSE: Non-conforming Event Management: A problem and resolution log related to equipment is main- tained in the calibration log. A system is maintained to record all other occurrences and related actions and/or resolutions. 8. QSE: Assessment (external and internal): Quality indicators will be developed, monitored, and changed as appropriate. 9. QSE: Continual Improvement: Opportunities for improvement may be identified through internal assess- ment, review of test results, accrediting or regulatory agencies and external assessment. 10. QSE: Customer Focus: A method to evaluate satisfaction with services will be maintained and monitored to identify opportunities. 11. QSE: Facilities and Safety: The environment is designed to provide safety for all and meet all accreditation and regulatory requirements.

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