ATS Pulmonary Function Laboratory Manual

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

Equipment 1.

Selection of new or replacement equipment (11, 12) 1.1.

Define the needs of the laboratory and healthcare system.

1.2.

Develop a product evaluation matrix.

1.3. Develop a list of acceptable vendors based on the defined equipment needs and required specifica- tions. 1. Consider: a. Food and Drug Administration approval b. Selected equipment should meet or exceed minimum American Thoracic Society (ATS)/ European Respiratory Society (ERS) equipment performance standards (7). c. Acceptable limits of accuracy and precision d. Specifications for linearity, hysteresis, signal damping and response time e. Compatibility of instrument components, costs, limitations, and software or hardware f. Frequency and verification standards for software updates g. Ease and method of infection control for equipment and accessories h. The use of disposable or non-disposable items for measurement of flow or volume parameters i. Fixed and variable costs of the system j. Availability of supplies k. Effect of filters on equipment performance and test results 1) The total system resistance to airflow must be less than current ATS/ERS equipment recommendation (currently 1.5 cm H 2 O/L/s) (7). l.

Data base management options, which may include: 1) Patient records and quality control records 2) Preventive maintenance schedules 3) Quality assurance programs 4) Performance improvement indicators 5) Staff or patient scheduling options 6) Network and interface options with other systems m. Quality control standards and ease of calibration routines n. Available reference standards (normal prediction equations) o. Training options and costs for operators p. Technical support

1.4. The terms of agreement should include expected response times for service/uptime guarantee. 1.5. Consider the computer standards for the healthcare system. 1.6. Verify that calculations included in the software are accurate. 1.7. Verify that the equipment has been tested by an independent testing agency. 1.8. The equipment should comply with regulatory agency requirements, for example the National Institute for Occupational Safety and Health (NIOSH), and Social Security Income Administration standards for disability. 1.9. Warranty and service agreements should be well defined. 1.10. Perform an on-site evaluation of the equipment. 1. Simulate normal and abnormal conditions for quality control and patient testing. 2. Determine if the equipment meets special considerations for the age and population to be tested. 3. Evaluation tools may include a calibrated syringe and biologic standards (controls). 4. Complete a biomedical evaluation (safety check).

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