Laboratories conducting diagnostic testing, classified by the U.S. Food and Drug Administration (FDA) as non-waived, are required to be compliant with the 1988 regulations of the Clinical Laboratory Improvement Amendments (CLIA).1 In addition, laboratories are required to undergo an assessment of their compliance with CLIA regulations every two years. The Centers for Medicare and Medicaid Services (CMS), which administers the CLIA program, has assigned numerous organizations deeming authority to survey laboratories and assess compliance with these regulations.
These requirements can seem overwhelming. So, how does a healthcare organization keep its laboratory survey ready? In this article, we’ll describe some of the most common challenges laboratories face in preparing for an accredidation survey.2
During the on-site survey event, the surveyor will review written documents. Preparing for this part of the assessment is often challenging for organizations.
Below are a few questions to ask yourself and your team to determine if your organization is prepared for an on-site survey event:
- What documentation is required for an on-site survey?
- Do the appropriate personnel have access to the documentation required to perform their duties?
- Is access to the required documentation readily available for review during an on-site survey?
- Is the healthcare organization’s documentation organized, whether it is paper or electronic, to easily support the survey process?
Laboratories are required to provide numerous completed documents during the on-site survey including:
- The laboratory personnel report (CMS form 209)
- A test menu including all specialties and subspecialties. The menu also should include proficiency testing (PT) data that is organized by Clinical Laboratory Improvement Amendments (CLIA) number. All pertinent data for the last 24-months should be available for the surveyor, including all worksheets, attestations, and corrective actions.
- A list of tests that do not use PT for verification of precision and accuracy
- Alternate PT results
- An Individual Quality Control Plan (IQCP) for applicable tests, including process improvement data for the last 24-months
- The laboratory’s emergency operations plan
- Several of these documents are particularly challenging for many laboratory managers.
For example, some healthcare organizations struggle with completing the CMS-209 form that is used by the surveyor to review the qualifications of technical personnel in the laboratory. The form can cause confusion because titles used within a laboratory may not align with the nomenclature used by CLIA to identify roles and qualifications needed to perform testing and provide laboratory oversight.
Before identifying personnel to fulfill supervisory roles, it is important to review the CLIA-defined educational requirements needed to perform laboratory duties based on the level of test complexity. It is also important to review roles for both moderate and high-complexity testing.
Moderate complexity testing requires that healthcare organizations assign the following roles: Laboratory Director, Technical Consultant, and Clinical Consultant. High-complexity testing requires that organizations assign the following roles: Laboratory Director, Technical Supervisor, Clinical Consultant, and General Supervisor. Additional information regarding specific qualifications and responsibilities of these roles can be found in the CLIA regulations Subpart M.
Another challenging component of the survey review process is the Individual Quality Control Plan (IQCP). This is a process that consists of three components — Risk Assessment (RA), Quality Control Plan (QCP), and Quality Assurance Plan (QA). All three components must be approved by a Laboratory Director prior to implementation of the QCP.3 IQCP approval may be documented by a Laboratory Director’s signature on each component or on a cover sheet, which specifically indicates that the director reviewed each of the three components. A cover sheet with only one signature is not adequate, as it must stipulate review of all three components.3
Standards may contain multiple elements of performance (EPs), including a written checklist, which identifies EPs in which written documentation is required. As the standard states, “The laboratory verifies and documents that the applicant has the education and experience required by the job responsibilities.”3 Proof of this documentation will be reviewed during the on-site survey event. In preparation for the survey, organizations should review the written document checklists by chapter and ensure they have documentation for each of the standards by EP where required.
Competency continues to be an area where organizations struggle. It remains the number one cited standard, 4 and has held its place on the top-cited list for many years.
So why do organizations struggle with competency? After all, competency standards have been in the CLIA requirements since their inception. It seems the biggest challenge of competency is meeting CLIA requirements about the qualifications associated with a job title, and specifically for Technical Consultant for moderate-complexity testing and Technical Supervisor for high-complexity testing. Individuals must meet the education requirements and, either, training or experience requirements listed in the CLIA regulations Subpart M for each of the specialties and subspecialties performed by the laboratory.
Laboratories must assess and document the competency of laboratory personnel involved in non-waived testing. CMS requires labs to assess six elements for each type of test that each individual performs:
- Routine patient testing assessed through direct observation
- Reading and reporting of test results and review of intermediate test results assessed by monitoring
- Quality control (QC), proficiency testing (PT), and preventive maintenance
- Instrument maintenance and function checks assessed through direct observation
- Test performance assessment
- Problem-solving skills assessment
Problem-solving skills are imperative and are often an overlooked required element of a competency assessment. It is also necessary to ensure that the person performing the competency assessment meets CLIA required qualifications. For example, when performing moderate complexity testing, the individual performing the direct observation of another person performing that test must qualify as a Technical Consultant, per the CLIA specified qualifications. It is also important to note that competency is per CLIA certificate, so if staff is performing the same testing using the same instrumentation in different locations, a competency assessment, including all six elements, must be performed at each location.
Commonly cited proficiency testing standards
Standards related to PT are among the top ten annually cited standards. The standard states, “A laboratory will participate in CMS-approved proficiency testing programs for all regulated analytes.”5
One common basic pitfall is an organization’s lack of implementation of a process to address adding a new test to its menu. When a laboratory is adding a new test to its test menu for regulated analytes, it is important to put a process in place to ensure that it adds the new analyte to its PT ordering. Another basic requirement is for the Laboratory Director to review each proficiency testing program report, even if testing events are satisfactory and the review is documented. The Laboratory Director may delegate this responsibility, in writing, to an individual meeting the CLIA requirements of technical consultant for moderate complexity testing or someone meeting the CLIA requirements for technical supervisor for high-complexity testing.
Additionally, a thorough corrective action is required for any unsuccessful PT event. This often offers healthcare organizations the opportunity for improvement. When organizations respond to unsuccessful PT by merely documenting “Repeated and OK” or “Random Error,” it does not foster improvement. Instead, a full investigation should be conducted to ensure patient samples performed during the same time frame were not affected. PT samples should be integrated into the laboratory’s normal workflow and rotated among staff performing patient testing.6
Healthcare organizations should follow a normal testing process for PT samples, until the process requires that the sample be sent to another laboratory for validation. PT samples cannot be sent to another laboratory for testing. Sending samples to another laboratory for testing is considered PT referral and carries significant consequences, per the CLIA regulations. It is also important to remember that PT samples are specific to the CLIA certificate.7,8
Correlation, or comparison testing, also is high on the list of most-cited standards. Correlations are required when the same test is performed on different instruments, by different methods, and/or in different locations.9 The goal of correlation testing is to ensure that results for the same test will be equivalent — no matter what instrument, method, or location is involved.
Some typical observations from surveyors include the following: correlations are not performed every six months, or at all; failure to correlate automated and manual differentials; and failure to correlate point-of-care testing locations, the emergency department, or other locations with the main laboratory.
It is imperative that healthcare organizations plan well in advance for their laboratory survey. Hours dedicated to preparation will certainly pay off, resulting in a successful laboratory survey that overcomes obstacles and meets necessary requirements.
Heather Hurley is the Executive Director of Laboratory Accreditation at The Joint Commission. In this role, Hurley leads business strategies and activities, including the development and implementation of products and services for The Joint Commission’s Laboratory Accreditation Program, Patient Blood-Management Certification and Integrated Care Certification.
Hurley also leads The Joint Commission’s Laboratory Professional Advisory Council and serves as liaison to associations, collaborative partners, and accrediting and regulatory bodies in the laboratory field. In addition, she provides technical oversight and assistance in support of the development of laboratory accreditation manuals, standards, education programs and other accreditation-related materials.
- Centers for Disease Control and Prevention. Clinical Laboratory Improvement Amendments (CLIA). https://www.cdc.gov/clia/law-regulations.html. Updated August 6, 2018. Accessed February 1, 2022.
- Joint Commission Resources. Comprehensive Accreditation Manual for Laboratory and Point of Care Testing (CAMLAB), 2020.
- Joint Commission standard HR.01.01.01 EP 3
- Joint Commission standard HR.01.06.01.
- Joint Commission standard QSA.02.04.01.
- Joint Commission standard QSA 01.02.01.
- Joint Commission standard QSA.01.04.01.
- Joint Commission standard QSA.01.03.01
- Joint Commission standards QSA.02.08.01.