Quality Assurance Basics Course Information

This is a 1-credit introductory course that is part of the required study in the area of quality assurance. It is a prerequisite to the course, Quality Assurance Projects, a 2-credit course that can be taken concurrently.

Quality Assurance Basics examines the U.S. regulatory perspective, the many CLIA requirements that impact all test sites, and the voluntary accreditation process. While CLIA'88 establishes the minimum requirements that all test sites must meet, many test sites choose to be accredited by HCFA "deemed," professional organizations, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), College of American Pathologists (CAP), and the Commission of Office Laboratory Accreditation (COLA). These sites must adhere to the organization's standards and pass its inspection process.

Sharon S. Ehrmeyer, Ph.D. is the primary instructor for this course. Dr. Ehrmeyer is a Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School and Director of the Clinical Laboratory Science Program. Many of the course readings are from the Poor Man's Guide to Meeting the Regulations. She and Dr. Ronald Laessig, Director of the Wisconsin State Laboratory of Hygiene, are the authors of this guide.

This course is intended for clinical laboratory scientists who have an interest in or responsibility for developing and overseeing total quality management and continuous quality improvement of laboratory testing processes. It should be especially useful for directors and managers of healthcare laboratories, clinical chemists, QC technologists and specialists, teachers and students in Clinical Laboratory Science programs, instrument developers, manufacturer's technical and field specialists, and laboratory inspectors.

The emphasis is on the regulations that govern all laboratory testing, regardless of the specific location performed. Assuring quality or quality assurance is a concept tied to the theories of "total quality management" and the closely related concept of "continuous quality improvement." All testing must meet the minimum requirements specified in CLIA. A test site achieves this through its defined quality assurance program, which includes policies and procedures that ensure adherence to testing requirements and include mechanisms to evaluate the quality of the testing process, identify and correct problems, and assure the adequacy and competency of the staff. The backbone to achieving this is understanding the regulations identified in CLIA and accreditation programs.

Goals

• Participants who complete the lessons in this course will be able to:
• Review the history of U.S. clinical laboratory regulation.
• Discuss why CLIA'88 was implemented and the purpose of CLIA's requirements.
• Review the types and the process for obtained CLIA certificates.
• Describe HCFA deemed and exempt status under CLIA
• Identify the CLIA'88 requirements (QC, patient test management, personnel standards, training, PT, QA, inspection) based on test complexity and mandated for all laboratory tests sites.
• Access Internet sources of information for regulatory requirements.
• Discuss professional accreditation and requirements for testing under CAP, JCAHO, and COLA.
• Compare and contrast CLIA, JCAHO and CAP requirements for specific testing applications.
• Select regulatory schemes (CLIA, JCAHO, CAP, or COLA) for various testing situations.

• All the materials for this course are available via the Internet.
• The Course Syllabus outlines the order of the lessons and provides links to individual lesson plans.
• Each Lesson Plan provides a summary of the lesson, specific learning objectives, a list of materials, a list of things to do, and self-assessment exercises.
• A Lesson may involve text material, Internet references, journal articles.
• A Glossary of Terms is available and can be accessed from any lesson.
• A Reference List identifies the scientific papers that are the basis of the approach and the background for the course materials.

• Participants are encouraged to submit questions by e-mail. These questions will be summarized and a representative sample will be posted.
• Each participant is encouraged to find a mentor who will be available to discuss the lessons and self-assessment exercises.

1. Why CLIA'88? Few regulations for laboratory testing existed before 1967. CLIA'67 and Medicare '68 affected only large hospital laboratories and laboratories engaged in interstate commerce. Primarily as a result of poor quality PAP testing, HCFA, through CLIA'88, now regulates all laboratory testing (except tests used solely for research) performed on humans in the U.S. Approximately 169,600 laboratories currently are registered and all test sites must follow the many mandates identified in a series of Federal Registers.
2. What are the types of CLIA certificates and how are they obtained? All test sites must perform testing under an appropriate CLIA certificate. Laboratories need to apply to HCFA for a certificate and the certificate issued will depend on the type of tests performed and whether the site is seeking professional accreditation from a HCFA deemed organization. Certificate types include: waiver, professional performed microscopy procedures, registration, compliance and accreditation.
3. What is test complexity under CLIA'88? CLIA'88 is unique in that it categorizes all tests according to the complexity or difficulty to perform the testing. The FDA selects the appropriate category based on the required knowledge, skills and background necessary to perform a particular test methodology. There are three major complexity levels - waived, moderate and high. The many requirements to assure quality vary with complexity.
4. What are the personnel standards for laboratory testing? CLIA'88 identifies personnel standards (education/training and responsibilities) based on test complexity. For example, a test site performing only waived testing is not required to adhere to any personnel standards. Under the Provider-Performed Microscopy category, only physicians, dentists, nurse practitioners, nurse midwives, or physician assistants can perform 9 tests that are associated with specimens collected as part of a physical exam. The required personnel positions, training and specific responsibilities are identified for test sites performing moderate and high complexity testing.
5. What are CLIA's quality requirements for patient test management? CLIA'88 identifies processes to ensure positive patient identification and sample integrity throughout the testing phases - pre-analytical, analytical and post-analytical. Test site's policies and procedures must encompass these requirements.
6. What is included in a procedure manual? A major focus of the inspection process is the test site's procedure manual. CLIA'88 draws heavily on the NCCLS' Clinical Laboratory Technical Procedure Manual document (GP2-A3). The procedure manual is the place where the regulations come together - the philosophy, the strategy, the tactics, and the implementation.
7. What are CLIA's method and performance verification requirements? Verification represents a series of "laboratory exercises" to ensure and document that the method, initially and on an on-going basis, is working properly. CLIA bases its verification requirements on test complexity.
8. What are CLIA's QC (process control) requirements? CLIA was implemented to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. QC requirements, which include calibration, calibration verification, remedial actions and documentation are identified for test complexity and, in some cases, specific analytes.
9. How are CLIA's proficiency testing requirements met? Under CLIA, PT is mandated as an external assessment tool for all test sites performing moderate and high complexity tests. CLIA specifies which professional organizations or states can provide PT; what analytes must be evaluated by PT; how PT samples are to be handled; what constitutes successful, passing performance; and what sanctions are applied for PT failure.
10. What are CLIA's requirements for personnel training and on-going competency assessment? Essential components to ensuring quality test results are training and competency assessment. Initial training and at least yearly, on-going competency assessments must be documented. The technical consultant is responsible for the competency of personnel performing moderate complexity tests and the technical supervisor is responsible for those personnel performing high complexity tests.
11. What is deemed and exempt status under CLIA? While all testing sites must meet the minimum requirements of CLIA'88, CLIA may deem a laboratory as meeting its requirements through accreditation by a private, (deemed) nonprofit, HCFA-approved accreditation program or by meeting the requirements in a CLIA exempt state. Currently, there are six approve accreditation programs and two exempt-states - New York and Washington. Test sites seeking accreditation from one or more of these professional accreditation organizations or licensure from an exempt-state must adhere to the standards of the organization or state and show compliance through biannual inspections.
12. What are CAP, JCAHO, and CAP in terms of HCFA-approved accreditation organizations? The three most widely used private, (deemed) nonprofit, HCFA-approved accreditation programs are the Laboratory Accreditation Program from the College of American Pathologists, the Joint Commission on Accreditation of Healthcare Organizations, and COLA, formerly known as the Commission on Office Laboratory Accreditation. Although each organization's testing requirements are at least equivalent to those of CLIA, each has a somewhat different testing requirements and philosophies in reaching its goal of quality laboratory testing.
13. What are CLIA's quality assurance requirements for assuring quality? CLIA states: "The QA program is designed to monitor and evaluate the ongoing and overall quality of the total testing process. CLIA enumerates ten specific sections of the regulations, which need to be addressed as part of a QA program. All inspectors will ask for the written Laboratory-wide QA plan that identifies the test site's overall approach to QA including how some of the goals in the plan will be achieved.
14. What is involved in an inspection? Most test sites are inspected every two years for compliance to CLIA or an accrediting organization's requirements. If a test site has not chosen to be accredited by a HCFA deemed organization or is not located in a state with "exempt" status, HCFA inspectors will inspect the site for compliance to CLIA's regulations. For a successful inspection, it is essential that sites prepare and have all the documentation in order clearly showing that all requirements are being met. Test sites being inspected for CLIA compliance may be eligible for self-inspection through AQAS providing they routinely pass PT and have a record of successful on-site inspections.
15. What are the answers to some frequently asked questions concerning CLIA'88? On-line practical exam.
16. On-line examination.