Printed from acutecaretesting.org
February 2004
The new CLIA quality control regulations and blood gas testing
Introduction
The QC and calibration requirements of CLIA have been in effect for over 10 years [1,2]. All are based on test method complexity or difficulty to perform the testing. Currently, blood gas instrumentation used for POCT as well as that used in the central laboratory is classified as moderately complex.
The initial minimum QC standards for blood gas testing, described in the February 28, 1992 Federal Register, included: following manufacturers' directions; having a procedure manual that specifies how to perform tests and report results; performing and documenting calibration procedures (or verifying calibration) at least once every six months; assaying at least one QC sample every eight hours of testing and including a calibrator or control in each run unless the instrument is calibrated or self-calibrates at least every 30 minutes; performing and documenting remedial actions; and maintaining records of all quality control activities for two years.
When CLIA’s requirements were first promulgated, electronic quality control was unknown.
Eventually CLIA allowed electronic controls to fulfill the daily QC requirement provided the manufacturer specified their use. These as well as other mandated quality practices were discussed previously [3].
The basic QC requirements changed on January 24, 2003 with the publication of the CLIA “Final Rule” [4]. In this rule, the former quality practices described in Subparts K (Quality Control), J (Patient Test Management), and P (Quality Assurance) for tests of moderate and high complexity were updated and combined into a new Subpart K (Quality Systems for Nonwaived Testing).
To ensure that test sites focus their quality efforts on all phases of the testing process, this new subpart adopts a quality systems approach and is organized to reflect the flow of a patient specimen through the laboratory.
Most of Subpart K centers on the analytical phase of testing and introduces a new term, “nonwaived testing.” Nonwaived replaces the former and differing QC requirements for the moderate- and high-complexity test categories with a single set of QC requirements for both.
Changes in QC blood gas requirements under the Final CLIA Rule
Method validation
Test sites must verify or establish the performance of all methods or test systems introduced after April 24, 2003 (§493.1253), the effective date for the Final Rule. If a test site has been using a method or instrument prior to the effective date, it does not have to revalidate the method.
For unmodified FDA-cleared or approved nonwaived blood gas systems, this includes evaluating: accuracy, precision, reportable range, and reference intervals (normal values).
Practically, this requirement is met when the laboratory evaluates the method or test system’s performance characteristics prior to placing the method into routine use, determines that the performance is adequate to meet the needs of the test site’s clientele, retains documentation, and follows the manufacturer’s instructions for operation, including calibration and QC.
If the system has been modified or is non-FDA-cleared, additional characteristics must be evaluated and documented.
Quality control procedures
Section §493.1256 describes the new requirements for the routine QC procedures. This section is quite different from the minimum requirements published in the February 28, 1992 Federal Register. Specifically, the general QC requirements that are relevant to blood gas testing are (emphasis added):
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(a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytical process. |
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(b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in §493.1253(b)(3). |
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(c) The control procedures must--
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(d) Unless CMS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must—
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The specialty requirements for blood gases in §493.1267 are identical to those published in the February 28, 1992 Federal Register under section §493.1245.
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(a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer. |
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(b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. |
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(c) Test one sample of control material each time specimens are tested unless automated instrumentation internally verifies calibration at least every 30 minutes. |
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(d) Document all control procedures performed, as specified in this section. |
We have underlined three of the above requirements that in our view are noteworthy – “having control procedures that monitor … the complete analytical process,” “detect immediate errors" and " equivalent quality testing."
Complete analytical process
The complete analytical process typically means from sample aspiration through measurement to generation of the test result.
In reading the new QC requirements, one is led to believe that electronic controls that monitor only the instrument’s readout and/or electronics and do not evaluate the complete analytical process would need to be used as described under “equivalent quality testing” (see below).
Detect immediate errors
By just meeting the minimum CLIA requirement for blood gases, one control every eight hours, it would be impossible for sites to immediately detect errors without some additional quality assurance activities such as frequent calibration. Certainly in deciding how much QC is necessary, the test site must strictly adhere to the manufacturer’s minimum operating requirements, consider the instrument’s performance specifications (long-term precision and accuracy), personnel’s competence, etc.
Equivalent quality testing
Subpart K launches another new QC concept – equivalent quality testing or control – and states that Appendix C, Regulations and Interpretive Guidelines for Laboratories and Laboratory Services, of the State Operations Manual (SOM) will provide more information [5].
In the past, CMS surveyors primarily used these Interpretive Guidelines during the inspection process to determine a laboratory’s compliance with a CLIA standard. The 500+ pages of Guidelines now are designed to be a companion to the Final CLIA Rule to help laboratories better understand and meet the CLIA requirements and to provide additional regulatory information not included in the Final Rule.
Test sites using methods employing procedural controls can choose to meet the general QC requirements (above) or to qualify the use of procedural controls as “equivalent quality control” by following either of the EQC options (below).
The specific option selected depends on the characteristics of the blood gas instrument being used. Notice that in the context of the SOM, “EQC” stands for equivalent quality control, not electronic quality control. Both of the options allow the daily, routine, use of non-traditional control procedures once the test system has been proved to be sufficiently stable over time. This stability must be demonstrated and documented. The two applicable options for blood gas systems are as follows:
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EQC Option 1. Test Systems with internal/procedural control(s) that monitor the entire analytic process If a test system uses one or more internal/procedural control(s) to monitor all of its analytic components and the laboratory using the test system successfully completes the evaluation process described below to demonstrate test system stability over time, the laboratory may use the equivalent quality control procedures described below in lieu of performing the applicable procedures specified in the regulations at §493.1256(d)(3)(i-ii for blood gases) and the applicable specialty requirements listed for routine chemistry §493.1267. Evaluation process: The laboratory must perform the test system’s internal control procedure(s) in accordance with the manufacturer’s instructions (but not less frequently than once each day of testing) and test two levels of external control material daily for 10 consecutive days of testing. If the internal and external control results are acceptable throughout the evaluation process, the laboratory may reduce the frequency of testing two levels of external control material from daily [or for blood gases, once per 8 hours of testing] to once per calendar month unless the manufacturer requires more frequent and/or additional external control testing. The laboratory must continue to perform and monitor the internal control(s) in accordance with the manufacturer’s instructions, but not less frequently than once each day of testing. |
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EQC Option 2: Test Systems with internal/procedural control(s) that monitor a portion of the analytic process Some internal/procedural controls monitor only certain components of the test system. Although the test system’s manufacturer may suggest other mechanisms to monitor the component(s) not checked by the internal/procedural controls, the laboratory is ultimately responsible for ensuring that all components of the analytic process are monitored. The laboratory may use the equivalent quality control procedures listed below in lieu of performing the applicable procedures specified in the regulations at §493.1256(d)(3)(i-ii for blood gases) and the applicable specialty requirements listed for routine chemistry §493.1267, when it can demonstrate the test system’s stability over time. Evaluation process: The laboratory must perform the test system’s internal control procedure(s) in accordance with the manufacturer’s instructions (but not less frequently than once each day of testing) and test two levels of external control material daily for 30 consecutive days of testing. If the internal and external control results are acceptable throughout the evaluation process, the laboratory may reduce the frequency of testing two levels of external control material from daily [or for blood gases, once per 8 hours of testing] to once per calendar week unless the manufacturer requires more frequent and/or additional external control testing. The laboratory must continue to perform and monitor the internal control(s) in accordance with the manufacturer’s instructions, but not less frequently than once each day of testing. |
Both Options have the same requirements when a control (internal and/or external) result is unacceptable:
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References+ View more
- If the repeat control result(s) are within range, no further corrective action is necessary and the laboratory may, as applicable, resume the evaluation process or continue the reduced frequency of external control testing.
- If the repeat control result(s) are not acceptable, the laboratory must identify the problem, take appropriate corrective action and follow the requirements at §493.1282(b)(2) before reporting patient test results. The laboratory must restart and successfully complete the evaluation process before reducing the frequency of testing external control materials.
Specifically §493.1282(b)(2) for corrective actions state: Results of control or calibration materials, or both, fail to meet the laboratory’s established criteria for acceptability. All patient test results obtained in the unacceptable test run and since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected. The laboratory must take the corrective action necessary to ensure the reporting of accurate and reliable patient test results.- All evaluation process and corrective action activities must be documented.
- Public Law 100-578, Section 353 Public Health Service Act (42 U.S.C. 263a) October 31, 1988.
- U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Fed Regist 1992; 57: 7002-186.
- Ehrmeyer SS. U.S. quality assurance regulations for decentralized testing. Available at: http://www.bloodgas.org
- US Centers for Medicare & Medicaid Services (CMS). Medicare, Medicaid, and CLIA Programs: Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications. Final Rule. Fed Regist Jan 24 2003; 16: 3640-3714. Current CLIA Regulations (including all changes through 01/24/2003) available at:http://www.phppo.cdc.gov/clia/regs/toc.aspx.
- CMS State Operations Manual Appendix C, Regulations and Interpretive Guidelines for Laboratories and Laboratory Services. Available at: http://www.cms.gov/clia/appendc.asp.
- Joint Commission on Accreditation of Healthcare Organizations. Comprehensive accreditation manual for pathology and clinical laboratory services. Oakbrook Terrace, IL: JCAHO, 2004. Available at: http://www.jcaho.org.
- College of American Pathologists. Laboratory Accreditation Program's Checklists. Northfield, IL. 2003. Available at: http://www.cap.org.
References
- If the repeat control result(s) are within range, no further corrective action is necessary and the laboratory may, as applicable, resume the evaluation process or continue the reduced frequency of external control testing.
- If the repeat control result(s) are not acceptable, the laboratory must identify the problem, take appropriate corrective action and follow the requirements at §493.1282(b)(2) before reporting patient test results. The laboratory must restart and successfully complete the evaluation process before reducing the frequency of testing external control materials.
Specifically §493.1282(b)(2) for corrective actions state: Results of control or calibration materials, or both, fail to meet the laboratory’s established criteria for acceptability. All patient test results obtained in the unacceptable test run and since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected. The laboratory must take the corrective action necessary to ensure the reporting of accurate and reliable patient test results.- All evaluation process and corrective action activities must be documented.
- Public Law 100-578, Section 353 Public Health Service Act (42 U.S.C. 263a) October 31, 1988.
- U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Fed Regist 1992; 57: 7002-186.
- Ehrmeyer SS. U.S. quality assurance regulations for decentralized testing. Available at: http://www.bloodgas.org
- US Centers for Medicare & Medicaid Services (CMS). Medicare, Medicaid, and CLIA Programs: Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications. Final Rule. Fed Regist Jan 24 2003; 16: 3640-3714. Current CLIA Regulations (including all changes through 01/24/2003) available at:http://www.phppo.cdc.gov/clia/regs/toc.aspx.
- CMS State Operations Manual Appendix C, Regulations and Interpretive Guidelines for Laboratories and Laboratory Services. Available at: http://www.cms.gov/clia/appendc.asp.
- Joint Commission on Accreditation of Healthcare Organizations. Comprehensive accreditation manual for pathology and clinical laboratory services. Oakbrook Terrace, IL: JCAHO, 2004. Available at: http://www.jcaho.org.
- College of American Pathologists. Laboratory Accreditation Program's Checklists. Northfield, IL. 2003. Available at: http://www.cap.org.
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