ATS Pulmonary Function Laboratory Manual

ATS Pulmonary Function Laboratory Management & Procedure Manual | 3rd Edition

Procedure Manual Design The design and format of the 3 rd Edition of the ATS Pulmonary Function Laboratory Management and Procedure Manual is based on the Clinical and Laboratory Standards Institute (CLSI) guideline QMS02-A6, Quality Manage- ment System: Development and Management of Laboratory Documents, 6 th Edition (1). This approved guideline is available from CLSI (940 West Valley Road, Suite 2500, Wayne, PA 19087). While the final form and wording of any procedure manual should be determined by the specific needs and organization of the laboratory or department, the ATS recommends the following as a minimal standard: 1. A loose-leaf notebook designed to allow easy updating, or electronic preparation and storage 2. The use of tabs and a table of contents 3. Process flow charts or tables are strongly recommended 4. Beginning each procedure on a new page 5. Using only current manufacturers’ literature (if it is used) and using it only to supplement the written procedure Procedure Manual Style Procedures should be explicit, easy-to-follow, and complete. A uniform style should be established and used throughout. In accordance with CLSI guidelines, the ATS recommends the following: 1. Indicate the page number and the total number of pages at the top or bottom of each page. 2. Include the effective date for the procedure on the first page. 3. Document the date of review of each procedure and include the reviewer’s signature. 5. Note if the procedure replaces an earlier one (document history). 6. Retain obsolete or suspended procedures either in the manual or in a separate file, and keep them for at least 2 years. The procedure manual is also written using the CLSI “Path of Workflow” concept, which is based on a model that is described in the CLSI guideline Quality Management System A Model for Laboratory Services (QMS01-A4) (2). This concept recognizes that quality testing incorporates every stage of the testing cycle, which includes the pre-test, test, and post-test phases. Format for Technical Procedures The technical procedures should be written in a uniform style and contain the following: 1. Procedure Name —concise and descriptive 2. Purpose or Principle —written in paragraph form with comprehensive indications and contraindications 3. Equipment and Supplies —a listing of what is needed to perform the test (e.g., nose clip, tissue, and mouthpiece) 4. Patient Preparation (Pre-Test Instructions) —specific instructions for the patient (e.g., which medications to withhold and for how long) 5. Assessment of Patients (Pre-Test) —specific instructions on assuring patient has complied with preparation instructions and has the ability to perform the test procedures 6. Equipment Preparation and Calibration Checks (Pre-Test) —directions for preparing the instrumentation and supplies; detailed, stepwise instructions, and frequency and tolerances for calibration

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