ATS Pulmonary Function Laboratory Manual

chapter  3

1.11. Establish cost-per-service versus profit ratios. 1.12. Compare test results between the old equipment and the new equipment. 2. Preparation of equipment for testing 2.1. New equipment must be validated prior to patient testing (12). 2.2. Allow for adequate warm-up time for each piece of equipment. 2.3. Perform quality control as required for each procedure. 2.4. Verify calibration as indicated for equipment and type of procedure. 2.5.

Attach additional supplies as required for the procedure (e.g., mouthpieces, hoses).

Patient Privacy 1. Patient privacy during test performance must be maintained to meet regulatory requirements and improve comfort and compliance with testing. 2. Patient confidentiality must be maintained at all times (13). 3. Medical records should be maintained so as to prevent access by unauthorized personnel (13). 3.1. Medical records and medications should be maintained in locked files or in a locked room to which only authorized personnel have access. References 1. American Thoracic Society and European Respiratory Task Force. Standardization of lung function testing: general considerations for lung function testing. Eur Respir J 2005;26:153–161. 2. Clinical and Laboratory Standards Institute. QMS01–A4, quality management systems, a model for laboratory services: approved guideline, 4th ed. Wayne, PA: Clinical and Laboratory Standards Insti- tute; 2011. 3. Clinical and Laboratory Standards Institute. QMS07–A2, application of a quality management sys- tem model for respiratory services: approved guideline, 2nd ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2006. 4. Mottram CD. Ruppel’s manual of pulmonary function testing, 10th ed. Elsevier; 2012. 5. College of American Pathologists. General laboratory checklist; 2014. 6. The Joint Commission (TJC). Accreditation manual. 2014. 7. American Thoracic Society/European Respiratory Society. Standardization of spirometry. Eur Respir J 2005;26:319–338. 8. Blonshine SB. Integrating education with diagnostics: patient and technologist. Respiratory Care Clinics of North America 1997;3:139-154. 9. Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care facilities. MMWR 2005;54:N17. 10. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2014 Update. 11. Clinical and Laboratory Standards Institute. QMS13-a, quality management systems, equipment: approved guideline. Wayne, PA: Clinical and Laboratory Standards Institute; 2011. 12. Wanger J. Equipment validation: developing a strategy in the pulmonary function laboratory. Advance for Respiratory Care Managers September 1996;39–43. 13. U.S. Congress. Health Insurance Portability and Accountability Act of 1996 (HIPAA), 67 FR 53182.

27