2000 OPEN FORUM Abstracts
Practical Blood Gas Quality Control
Susan Blonshine, RRT, RPFT, FAARC Owner & Director of TechEd Consultants
The goal is to assure the medical reliability of laboratory data through quality control (QC), quality assurance (QA), and the quality systems. Systems must exist to assure test results are dependable. Accreditation or regulatory agencies such as Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the College of American Pathologists, (CAP), and CLIA '88 require documentation of a quality control program.
Proficiency testing services are required that equal or exceed laws or regulations. The requirement for proficiency testing includes the availability of a cumulative record. Laboratories must perform proficiency testing in the same manner as patient samples. One must evaluate the performance of proficiency testing for acceptability and trends.
Quality control includes the validation of methods. In addition, correlation or results is required when the same test is performed with different equipment or methods. The QC system also includes the reagents and labeling of the reagents. The QC program should be determined in conjunction with the Medical Director with control limits on the tests that are consistent with meaningful data. At minimum, three levels of quality control are evaluated each day with at least one level per eight hours to meet CLIA '88 requirements. The QC program design may require running controls more frequently and alternating levels. The driving force in developing QC requirements is meaningful clinical data. Statistical parameters are determined for each lot of QC material and the acceptable limits defined. Quality control (QC) results must be acceptable before reporting patient results. The quality control system should have daily surveillance by a director or supervisor.
Establishing criteria for remedial action is also part of the quality control program. Remedial action should occur concurrent with the identified problem and be consistent with defined QC policies, defined preventive maintenance procedures, proficiency testing, and equipment inspection policies. Documentation of repeat testing or quality control is included in remedial action. When developing the remedial action criteria, consider the correction of individual results and acceptable response times for correction. Design a system, which is adequate to correct all deficiencies and includes a process to review actions for the adequacy of a remedial action response. Documentation of remedial action applies to unacceptable quality control results, testing instrument variances, reporting of incorrect test results, and unsatisfactory specimen collection or testing.
Retention of the QC records is essential to meet regulatory requirements and provide a basis for evaluating trends that may trigger appropriate troubleshooting.