ATS Pulmonary Function Laboratory Manual

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

The blood gas laboratory’s policy and procedure manual should describe in detail the QC program including type of controls and how often they are to be analyzed.

Proficiency Testing Proficiency testing is a comprehensive tool in the quality management system that evaluates the entire blood gas test. It involves the analysis of specimens with unknown values and statistically compares the results with a peer group. A minimum of 10 laboratories from a regional geographical area comprise a peer group. The reporting facilities in the peer group must use the same model device and test at a similar altitude. Proficiency test samples must be analyzed as patient tests within the environment where testing occurs. The proficiency testing providers assess the individual site’s data and notify the laboratory of how their results compared to the peer group. All analytes defined by CLIA as “regulated” must participate in a proficiency testing program. Typically proficiency testing programs supply five samples at various levels or concentrations of analytes. A satisfactory performance is set at 80% for each individual testing event. This allows for one unacceptable result or deficiency. When a deficiency is cited by the proficiency testing provider, the site must investigate and document its findings. System Audits System audits are an essential part of every blood gas laboratory. They allow for closer examination of the policies and procedures and can identify possible sources of error before they occur. Auditors should be familiar with the test system but not involved with the development of the polies or procedures. The audits should involve: patient identification, sample collection and handling, instrument operation and maintenance, QC data analysis, results reporting, proficiency testing, and noncompliance management. Operator Training and Competency Certification Annual training is required by all regulatory bodies and should entail a review of the laboratory’s policy and procedure manual. The training documentation can include a written assessment, direct observation of specimen testing, and certification with a skills checklist. The skills checklist should include: obtaining a sample, performing an analysis, reporting results, correctly managing critical values, and identifying the location of the policy and procedure manual. Inventory Management The date when reagents and supplies are received is documented to assist with inventory management. It is also necessary to note when supplies or reagents are removed from temperature-controlled storage units. Daily temperature monitoring and recording of the instrument’s environment, reagents, and quality control material is mandatory.

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