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Follow Manufacturer's Directions to the “T”

Section Editor(s): Ehrmeyer, Sharon S. PhD, RN

Regulatory Affairs

Section Editor

Author Information

About the Editor: Sharon Ehrmeyer, PhD, RN is Professor of Pathology and Laboratory Medicine, Medical School, University of Wisconsin in Madison, where she directs the four-year, undergraduate Medical Technology/Clinical Laboratory Science Program. Her research focuses on quality issues related to laboratory testing. This focus began with evaluative studies conducted on the ability of proficiency testing to assess intralaboratory performance and then expanded to include the impact of the many Clinical Laboratory Improvement Amendments (CLIA '88) requirements on testing practices. Her interest in POCT began at a National Committee for Clinical Laboratory Standards meeting in 1991 with a presentation by Dr. Edwin Whitehead. He spoke of technology changes that would move testing, other than glucose and urines, out of the laboratory and closer to the patient and allow almost anyone to do it.

Regulatory affairs are a complex and evolving aspect of POCT. Understanding and remaining current on regulatory requirements requires ongoing review and reassessment. This column will provide updates on regulatory affairs and discussions of related topics of interest to professionals that manage POCT. In each edition of the journal, I will highlight a particular topic from contemporary practice. Over time, this section of the journal will build a reference guide to regulatory affairs and POCT.

The most frequent deficiency found in CLIA inspections of test sites performing only nonwaived testing for the last two inspection cycles is failure to follow manufacturers' directions.1 Much of POCT is classified as waived testing, and CLIA's only requirement for this classification is to follow manufacturers' directions. While the government does not inspect waived testing for compliance, the Centers for Medicare and Medicaid Services (CMS), recently conducted a pilot study of waived testing in Colorado and Ohio. This study was undertaken because of the increasing number of waived tests, the large number of POCT sites with essentially no oversight, and serious noncompliance findings in complaint investigations.

To confirm the findings of the initial study, CMS expanded it to include eight additional states. It was found that within these 10 states, 32% of the waived test sites failed to have current manufacturer's instructions, 32% did not perform quality control (QC) as required, 16% failed to follow current manufacturer's instructions, and 7% did not perform calibration as required by the manufacturer.1

Many POCT sites follow the test standards mandated by CLIA-deemed professional accrediting bodies such as the Joint Commission on Accreditation of Health Care Organizations (JCAHO) and the College of American Pathologists (CAP). Each has more stringent requirements than the CLIA for POCT. Barbara Goldsmith, Director of POCT Programs at Alliance Laboratory Services (Cincinnati, Ohio), surveyed five POCT sites in her CAP-accredited facility and identified several specific causes of POCT errors. Failure to follow procedures topped her list. She recommends that after selecting a POCT device, the first step in ensuring high-quality POCT is to develop written procedures in a language that is understandable and easy to follow by nonlaboratory personnel.2 It is also important to note that the written procedure should reflect both the recommendations of the manufacturer and those of the individual site or institution.

Having a procedure manual that all personnel who will be administering tests can follow, is key to quality POCT. While the CLIA has no specific procedure manual requirement for waived testing, test sites performing waived tests must follow manufacturer's directions. It should also be noted that if POCT sites are not following the manufacturer's directions, the waived tests are automatically classified as highly complex and all CLIA requirements for that category of testing must be followed.

For moderately complex POCT, test sites inspected by the government (CMS) must follow section 493.1202 (c) (2) in Subpart K of the February 28, 1992 Federal Register. This includes having a procedure manual that describes the processes for testing and reporting patient test results.3 The laboratory may use the manufacturers' package inserts or operators' manuals, but must supplement these instructions when specific test performance and reporting procedures, calibration, or control activities are not included.4

The JCAHO recognizes waived test methods as defined by CLIA '88, but unlike CLIA, has specific requirements for waived testing. Waived Testing Standard 1.3 requires proof that all testing personnel have access to current written procedures that include specimen collection and preservation, instrument calibration, QC and remedial actions, equipment performance evaluation, and test performance. For testing classified as moderately complex, written procedures must be available to all testing personnel and include policies and procedures for specimen collection and preservation, instrument calibration, QC and remedial actions, equipment performance evaluation, and test performance. The JCAHO requires documentation to show at least annual review and evaluation of the procedure manual by the POCT site's director or appropriate supervisor, and testing personnel must attest to their understanding of the document.5

The philosophy of the CAP laboratory accreditation program is that all clinical laboratory testing, including POCT, needs to adhere to the same quality requirements, regardless of the CLIA classification. The CAP specifically requires sites seeking their accreditation to have a procedure manual, which can be in electronic form. Previously, CAP required procedure manuals to be in substantial compliance with the NCCLS GP2-A3 document.6,7 The note associated with item AGC.21000 in the new automated/general chemistry checklist states that substantial compliance means the format can vary from GP2-A3 and only components relevant to the testing situation need to be included. The checklist also allows manufacturer inserts as part of the manual; however, the inserts cannot replace it, since the manual must reflect the circumstances (skill of testing personnel, QC, panic values, reference ranges, etc.) of the test site. The director (or director's designee) must initially approve the procedure manual and review it annually. All testing personnel must attest to their familiarity with its contents. This change in the CAP procedure manual requirement will be included in all checklists as they are updated.

Future columns will discuss the three remaining top four CLIA deficiencies, QC, quality assurance, and proficiency testing. Suggestions for topics to be included in future columns are welcome.

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References

1. Centers for Medicare and Medicaid Services for the Clinical Laboratory Improvement Amendments Program web site. Available at: http://www.hcfa.gov/medicaid/clia/cliahome.htm.
2. Goldsmith, BM. Point of care testing: how laboratorians can ensure quality beyond the lab. Clinical Laboratory News. April 2001; 27 (4): 6-8.
3. Codified Current Federal Register (Clinical Laboratory Improvement Amendments regulations) Centers for Disease Control and Prevention web site. Available at: http://www.phppo.cdc.gov/clia/pdf/42cfr49300.pdf.
4. Appendix C, Survey Procedures and Interpretive (Clinical Laboratory Improvement Amendments) Guidelines for Laboratories and Laboratory Services. Available at: http://www.hcfa.gov/pubforms/pub07pdf/ap%2Dc.pdf.
5. Joint Commission on Accreditation of Health Care Organizations (JCAHO). Comprehensive Accreditation Manual for Pathology and Clinical laboratory Services. Oakbrook Terrace, IL: JCAHO; 2001.
6. College of American Pathologists (CAP). Laboratory Accreditation Program. Northfield, IL: CAP; 2001.
7. National Committee for Clinical Laboratory Standards. Clinical Laboratory Technical Procedure Manuals. Approved Guideline (GP2-A3). Third ed. NCCLS: Wayne, PA; 1996.
© 2002 Lippincott Williams & Wilkins, Inc.