Ronald D. Feld, Ph.D., Marian Schwabbauer, Ph.D.*, CLDir(NCA), John D. Olson, M.D., Ph.D.
After completing this section, the reader will be able to:
1) Institute a QA program for a physician office lab.
2) List the requirements for QA contained in Subpart P of the Feb. 28, 1992, CLIA rules.
3) Design a QA monitors necessary to test facets of the laboratory testing process which require QA
4) Evaluate QA monitors for their effectiveness in resolving QA problems.
5) Describe the QA process in the following areas: patient test managment, quality control, proficiency testing, comparision of test results, personnel competency, complaint investigation, staff review, and QA records.
Latest Revision (March 11, 2003): Final CLIA rules relating to quality control were published in the January 24, 2003 Federal Register (http://www.phppo.cdc.gov/clia/pdf/CMS-2226-F.pdf). These rules take effect on April 24, 2003 but labs will have one 2-year cycle to come into compliance. Changes include:
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Quality Assurance
Quality assurance is a system for ensuring the quality of all facets of a laboratory's technical and non-technical function. The requirements for QA are discussed in Subpart P of the February 18, 1992 rules. QA is much broader in its scope than quality control which is mostly concerned with the analytical process. Quality assurance includes the evaluation of patient preparation and specimen collection, as well as the preanalytical, analytical, and postanalytical phases of laboratory testing.
The preanalytical phase of testing includes patient preparation and specimen collection as well as the preparation, preservation, and transportation of samples. The analytical phase includes the actual test analysis and the postanalytical phase includes test reporting and interpretation.
The laboratory must have a written QA policy which is communicated to all the laboratory staff. This document should contain methods for monitoring and assessment of all phases of the total laboratory process. The purpose of the QA policy is to prevent problems before they occur. This is a living document since no policy can anticipate all the problems which may occur. When an error or potential problem is discovered, corrective action must be instituted and documented. New policies or probes must be added to the written QA policy to prevent recurrence.
The inspector will expect to see a well-written QA policy that monitors all phases of the laboratory process, is actively reviewed, and shows evidence of remedial action when a problem is discovered and evaluation of that remedial action for effectiveness. All members of the staff who perform or direct laboratory testing should be familiar with the QA policy and its implementation when problems occur.
Although satisfying the QA requirement can be accomplished by many systems, an effective method is the QA committee. It is critical that the laboratory director be a member of this committee since this person is ultimately responsible for the acceptability of the QA program. This committee should meet on a regular schedule to review the effectiveness of monitors, establish new monitors, establish targets for monitors, review any identified problems, and institute corrective measures to alleviate identified problems.
Patient Test Management Assessment
This section of QA regulations is mainly concerned with patient test preparation (Subpart J) and obtaining and preparing specimens for analysis. There are many monitors which could be used to assess this area. Some examples are as follows:
Quality Control Assessment
According to the remedial action section of Subpart K, the laboratory must have a system which monitors remedial action. The inspector will want to see that the QC Policy is being following with respect to correcting analytical QC problems such as shifts, trends or out-of-limits QC data. The laboratory must also monitor for errors in reported results. This may involve review by a lab supervisor before release or self review by the analyst for transcription or data entry errors.
Proficiency Testing
Proficiency testing, as outlined in Subpart H, is one of the main ways HCFA assesses the quality of a laboratory. The laboratory must have in place a system for monitoring proficiency testing results and taking corrective action if there is a failure.
Comparison of Test Results
If laboratory testing is performed at several sites that have tests in common under a single CLIA certificate or if the same test is performed at the same or multiple sites using varying methodologies or instruments, then comparisons must be run twice a year to define the relationship between the methods or sites. This can be accomplished by performing a 20-sample or greater comparison using specimens covering the analytical range. The data is then graphed in an x - y comparison plot. The slope and intercept are calculated by a linear least squares program. The laboratory director may define what are acceptable limits. If the laboratory performs an analysis for which there is no accepted proficiency testing program, then accuracy must be assessed twice a year. This may be accomplished by running specimens of known value. It is rare that such esoteric tests are performed in a physician laboratory.
Review of Patient Results
This section emphasizes the correlation of patient test data with information such as sex, age, clinical data, and consistency within laboratory data. An example might be what is the correlation of the MCV in a patient with a low iron and elevated iron binding capacity. (This QA is covered in the accuracy of test reports under patient test management.) The inspector will question the availability of patient information and the system for correlating it with test data. A cumulative report format that correlates all patient data together with age, sex and clinical information is helpful for review. A plan for corrective action when inconsistencies are found should be available.
Personnel Assessment
The key concept of this section is competency. Competency can be addressed by several mechanisms. For example, a study set of peripheral blood films with a passing score determined by the director may be used as a competency test. Specimens of known value may be submitted as unknowns. Direct observation by a supervisor or a checklist of questions administered by a supervisor may be used to confirm competency. Competency testing must be performed at least annually.
The laboratory also needs a remedial action plan with respect to the competency of employees. If testing uncovers problems with an employee's competency, what solutions are available to bring the individual up to competency standards? This may consist of additional training or practice and retesting.
Communications
This section is concerned with information transfer in the form of a requisition or test order by the ordering physician and the reporting of results to the appropriate person. If there are requirements on the requisition such as clinical history, age, sex, etc., are these requisitions monitored for completeness? Do the reports present the test data in an easily understood manner? A survey of the laboratory's customers could be useful here.
Complaint Investigation
All complaints must be documented. Any investigation done to assess the validity of the complaint or to resolve valid complaints must be documented. Corrective action of problems identified through complaints must be documented as well as the actions taken to minimize recurrences.
Quality Assurance Review
All QA activities must be reviewed with the staff. This could take place at weekly or monthly staff meetings. The staff should be involved in QA review, suggesting corrective actions to minimize future errors. Minutes of the meetings as well as an attendance roster must be available.
Quality Assurance Records
As with all of CLIA, documentation is the key. QA records as well as the policy manual should be available to the staff and reviewed and signed by the laboratory director.
BMCX VERSION 1.F 06-23-95, 2:16 pm
DATE: 06-23-1995SYSTEM: 747 URIC ACIDTECHNOLOGIST: ML NO(S):_________________________________________________________ REAGENT LOT NO(S): R1 818629 R2 815675 REAGENT RECONSTITUTION DATE: R1 6-9-95 R2 6-9-95 SHIPMENT DATE _____________ CALIBRATOR LOT NO.: XLS-89 PRECILIN-S LOT NO.: SA4108 DEMONSTRATED LINEARITY/CALIBRATION VERIFICATION RANGE: ___ to ___ mg/dL QC RECOVERY _______________ (Acceptable Range: ___ to ___ mg/dL) QC RECOVERY _______________ (Acceptable Range: ___ to ___ mg/dL) __________________________________________________________________ BOTTLE 1BOTTLE 2BOTTLE 3BOTTLE 4BOTTLE 5BOTTLE 6 __________________________________________________________________ Theoretical 0.00 5.1710.3315.50 20.6722.73 __________________________________________________________________ Observed 0.005.2010.30 15.40 20.1022.70 Values 0.00 5.2010.40 16.50 20.5022.70 0.00 5.2010.30 15.40 20.6022.50 __________________________________________________________________ APPROVED: __________________________________ DATE:________________
BMCX VERSION 1.F 06-23-1995, 2:16 pm
LINEARITY/CALIBRATION VERIFICATION TABLE URIC_ACID PASS/FAIL CRITERIA: 0.14 mg/dL or 5%
Bottle FactorAverageTheoreticalAbsolute Percent Pass/ Result BiasBiasFail
1 0.00.00 0.000.00 N/A Pass 2 0.55.20 5.170.03 0.77%Pass 3 1.0 10.33 10.330.00 0.00%Pass 4 1.5 15.43 15.500.07 0.45%Pass 5 2.0 20.40 20.670.27 1.25%Pass 6 2.2 22.63 22.730.10 0.44%Pass
APPROVED:___________________________________ DATE:_________________
