Our laboratory has an extensive competency program focused on meaningful tasks that satisfy the “intent of the law.” Management has decided to refocus on the competency program, and one area that seems to be problematic is the definition of a test system.
Using chemistry as an example: is each kit test (mono, preg, TCA, HP) a test system? Or, are manual tests such as pregnancy or mono grouped together as a manual test system? The implication of the former is a survey for mono, maintenance for mono, a problem for mono, etc., leading to extra work in a time of diminishing FTEs and budget cuts. And the question would be “what is the value of this?” if one were making something up to have a maintenance/function test to check off.
CLIA’s definition is: “A test system means the instructions and all of the instrumentation, equipment, reagent, and supplies needed to perform an assay or examination and generate test results.”1
College of American Pathologists defines a test system as: “The process that includes pre-analytic, analytic, and post-analytic steps used to produce a test result or set of results. A test system may be manual, automated, multi-channel or single-use and can include reagents components, equipment or instruments required to produce results. A test system may encompass multiple identical analyzers or devices. Different test systems may be used for the same analyte.”2
According to CMS (CFR 493.1252), each test system must meet the manufacturer’s instructions and the laboratories “stated performance specifications,” as addressed in CFR 493.1253.3,4 The laboratory is responsible for defining criteria that address how reagents and specimens are stored, ensuring proper test systems’ functionality, and the reporting of accurate test results.
The article cited5 addresses these issues as related to blood bank and transfusion medicine, yet is applicable to other laboratory sections. The author states that “each method used defines a test ‘system’ and constitutes the need for a competency assessment activity. When tests are done on an automated instrument and all of the testing has the same problems and there are no unique aspects, the competency assessments can be combined.”
A test system would include any procedural function that may be used to aid in generating a test result. With the example of the chemistry instrument, one instrument performs a number of different tests using different reagents and could be considered a test system. It would be the lab’s responsibility to ensure that the instrument functions correctly (i.e., temperatures, clean probes, tubing, electrical fluctuations, water purity, etc.) in order to ensure correct measurement of each analyte.
Manual tests generally use reagents from a manufacturer’s validated kit, regents that are not to be mixed with other kits [“(e) Components of reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer.”2] Thus to assume all manual tests fall under a single test system (“manual test system”?) would not necessarily fit these established criteria. If a single kit produces multiple laboratory test values, then that could be considered a test system.
Furthermore, each test kit would require validation. CFR 493.1253 states a laboratory “that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristic…”3 These characteristics include establishing accuracy and precision and developing normal, age-based reference intervals. In addition, calibration and control protocols must be established, validated, and documented accordingly.
This brings me to another question. Does a kit test actually have a maintenance/function test that is appropriate? Droppers are included in most kits, and we do not routinely test timers. There is no instrument involved.
Maintenance and function checks must be completed for each test system as defined in section 493.1254: “The laboratory must perform and document the following: (a) (2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer’s established limits before patient testing is conducted.”6 Thus, function checks would be done only if the manufacturer’s guidelines indicate that it must be so and provides a timetable of how often it must be done.
The third question is similar to the chicken vs. the egg. Should the technical consultant check everyone, or should he or she be checked as well, since he or she works on the bench part of the time? Or, should the checkers be only management or general supervisors as designated by CLIA?
“Clinical consultants, technical consultants, technical supervisors, and general supervisors who are performing testing on patient specimens are also required to have a competency assessment including the six procedures.”7,8 The six procedures include the following:8
- Directly observing performance of routine patient testing
- Monitor[ing] how test results are recorded and reported
- Review of intermediate test results/worksheets, quality control results, proficiency testing, and preventive maintenance records of equipment
- Directly observing the performance of instrument maintenance and function checks
- Appraising test performances by retesting of previously analyzed specimens, testing blind test samples, or proficiency testing samples
- Evaluating problem-solving skills.
The last question concerns the review of intermediate test results. Recording a normal test released that was a manual entry with no intermediate clipboard to verify against seems not to be the intent. By definition, intermediate indicates that a result is transferred from one source to another.
CLIA regulations state:
“The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (1) Results reported from calculated data. (2) Results and patient-specific data electronically reported to network or interfaced systems. (3) Manually transcribed or electronically transmitted results and patient specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations.”9
And as noted in section 493.1413 standard, a technical consultant is responsible for the: “(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.”8 A system needs to be in place to ensure test results, whether intermediate or otherwise, are reliable before they are released.
The medical director of the clinical laboratory is ultimately responsible for interpreting and implementing CLIA and/or other agency guidelines. The intent of these guidelines is to ensure quality laboratory services are provided to patients, and to protect them and staff from untoward outcomes.
- State Operations Manual; Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Rev. 1, 05-21-04) https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_c_lab.pdf. Accessed November 21, 2014.
- CAP. Collage of American Pathologists All Common Checklist.(7/29/2013).
- Federal Register. 42CFR 493:1252. Standard; Test systems, equipment, instruments, reagents, materials, and supplies. 2003:598 https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_c_lab.pdf. Accessed November 21, 2014.
- Federal Register 42 CFR 493:1253. Standard; Establishment and verification of performance specifications.2003:597-598. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_c_lab.pdf. Accessed November 21,2014.
- Butch SH. Competency assessment in the transfusion service: tips and tools. MLO. 2013;45(10):8.
- Federal Register 42 CFR 493:1254. Standard; Maintenance and function checks. 2003:598. http://www.gpo.gov/fdsys/pkg/CFR-2013-title42-vol5/pdf/CFR-2013-title42-vol5-sec493-1254.pdf. Accessed November 21, 2014.
- CMS. What do I need to do to access personal competency? CDC, Brochure #10. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf. Accessed November 21, 2014.
- Federal Register. Standard; Technical consultant responsibilities. CFR493.1413.
- Federal Register. Standard; Test report. CFR 493.1291.