CLIA was established in 1988 with the goal of updating existing regulations related to the licensing of clinical laboratories, following the initial CLIA '67 rule. CLIA '88 regulations addressed test complexity, proficiency testing, quality assurance, and other clinical laboratory processes establishing quality standards for clinical laboratory testing for patient diagnosis and treatment. CLIA waived tests are generally simple test that are non-technical. There are over 1,400 test systems that have been waived. Most tests meet the following requirements:
If your lab is conducting only waived testing, you must have a valid Certificate of Waiver (COW) from CLIA and your lab will not be routinely inspected. However, COW labs may be randomly inspected as part of a compliance investigation to ensure that they are only performing waived testing. To qualify for a certificate of waiver, your lab must only perform tests that have received the CLIA waived status. If you meet this requirement, simply fill out the application form CMS-116 at the CMS website or from your state health. The COW is valid for two years. Information required is straightforward and includes:
For any lab that wants to manage risk, maintain the highest standards of quality and enhance patient safety, PT should be part of your ongoing quality assurance checks.In response to those COW labs that elect to participate in PT, MLE responded by preparing special modules of two-sample proficiency modules, designed for the CLIA-waived testing laboratory needs. Please refer to the current MLE Catalog on the Enrollment Information page for more information. A value-added service to enhance the quality and safety of patient care. The e-mail notification service will provide Class I and Class II recall information and field corrections pertaining to waived test devices. Additionally, MLE provides:
To receive “E-Notify on Waived Tests” and the “Recalls and Field Corrections: Devices—Class I and Class II” report, send an e-mail to and request to be added to the recipient list. In the e-mail request, be sure to include your MLE ID number.
Every physician would like to believe that his or her in-office lab executes tests properly and delivers results reliably. Unfortunately, a recent multi-year study identified a number of consistent errors in lab tests waived by the Clinical Laboratory Improvement Amendments (CLIA) program. The study, done by the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), identified problems with failure to maintain and follow manufacturers’ instructions, lack of quality control, and lack of documentation and recordkeeping that were outlined in a subsequent CDC report.1 This article offers suggestions based on the report to help your in-office lab improve quality, reduce testing errors and enhance patient health.
By law, lab tests can be classified as “waived” if they are simple tests with an insignificant risk of erroneous results.2 The list of waived tests, which originally consisted of eight tests, has grown to more than 1,800 test systems and at least 90 analytes, which are the substances or constituents that the test analyzes.
This proliferation of tests has made it more challenging to operate a waived lab, as each test has a specific set of instructions that must be followed precisely. In 2004, 58 percent of U.S. laboratories held certificates of waiver, which are issued by CMS to labs that only perform waived tests. The majority of these labs are in physician offices where they have no routine oversight or personnel requirements. They are only required to register, pay a biennial fee and follow manufacturers’ instructions when testing. As a result, most of the lab personnel do not have formal lab training or testing experience. This lack of exposure to good lab practices, coupled with a high turnover rate among testing personnel, is the source of many of the quality issues identified in the report.
The CDC recommendations are designed to promote the use of good lab practices by physicians, nurses and other providers of waived testing. They are presented here in the order of the testing process.
The CDC suggestions begin with questions you should ask yourself before you decide whether to perform waived testing or to introduce a new waived test. Here are the questions you should consider:
Who will be responsible for testing oversight, and are they properly trained? One staff member should be designated as the site director and held responsible for management of the testing operation. This person should have the appropriate background and training to make decisions about lab testing.
Is the lab prepared to meet all federal, state and local regulations? In addition to the federal requirements under CLIA, many state jurisdictions have regulations concerning personnel licensure, phlebotomy requirements and biohazard safety. If state regulations are more stringent than those specified by CLIA, then they supersede the federal requirements. Your lab can contact your state’s department of health to find out if any special rules apply.
What are the safety issues for both patients and testing personnel? Labs that hold certificates of waiver must comply with Occupational Safety and Health Administration (OSHA) worker-safety standards. The OSHA Bloodborne Pathogen Standard, which specifies that all test samples must be handled with universal precautions, also applies to lab workers. You can learn more about this regulation online at http://www.osha.gov/OshDoc/data_BloodborneFacts/. In addition, Health Insurance Portability and Accountability Act (HIPAA) regulations require that patients be protected from privacy violations, including any that might occur in the patient identification, test result reporting and recordkeeping processes. More information on HIPAA regulations is available online at http://www.hhs.gov/ocr/hipaa/.
Is the physical space adequate? Testing should be performed in a separate, designated area that is large enough to ensure safe testing and patient privacy. To ensure reliable results, environmental factors such as temperature, humidity and lighting must be considered.
What is the cost of offering the test in relation to the benefit in patient care? Consider the intended use of the test, the performance characteristics and your patient population before deciding to offer a new test. Also factor in costs beyond the actual test system. These could include supplies, reagents or controls that are not included with the test kit; equipment maintenance; the potential need for additional personnel; required confirmatory testing; and regulatory compliance.
Do you have sufficient personnel with adequate training to perform the test? Is your current staffing adequate? What will the impact be on workflow? How will you train new employees and maintain competency? You might want to assess your staff for color blindness, which can affect their ability to interpret test results based on color changes.
How will records and documentation be recorded and maintained? Documentation should include written test procedures that are easily accessible to testing personnel. (See “Key components of a waived test procedure manual.”) A comprehensive procedure manual might incorporate manufacturer package inserts. However, you should regularly review any package inserts included in your manual to see if they’ve been revised by the manufacturer. In the CMS/CDC study, 21 percent of waived labs reported that they did not routinely check the product insert for changes to the procedure, and 12 percent lacked the most recent instructions for the waived tests they were performing.
In addition, inserts should be supplemented with testing information unique to your office. Personnel training and periodic competency assessment must also be documented. Competency can be evaluated through observation, split sample testing or external proficiency testing programs.
The next stage of lab practice, referred to as the pre-analytical phase, occurs before testing begins. These good lab practices should be followed:
Confirmation of test orders. Confirm written orders by comparing them with chart notes or the presumptive diagnosis. Verbal orders for tests are acceptable if a system is in place to follow up with written confirmation.
Patient identification. Use middle initials, birth dates or identification numbers to avoid confusing patients who have similar names.
Patient preparation and pretest information. Provide patients with appropriate instructions if tests have special preparation (e.g., fasting before glucose testing). Advise patients about test limitations and the ways in which medications or medical conditions such as pregnancy might affect the test results.
Procedures for specimen collection and handling, including labeling. Directions for specimen collection from the package insert must be followed explicitly, including using appropriate collection devices. Substituting or altering collection devices can invalidate test results. Label samples immediately upon collection. If a sample is applied directly to the test device, then label the test strip/cassette before sample collection.
Preparation of test area and materials. Perform and record temperature checks and instrument calibration. Check and record expiration dates, discarding any outdated kits or reagents. Verify that instructions are current and unchanged for the test in use. Visually examine reagents or test kits for signs of deterioration. When you open a kit or prepare fresh reagents, record the lot numbers, expiration date and preparation date. Do not mix or combine reagents between lot numbers.
The report contains the follow recommendations for the testing, or analytical, phase:
Quality control. Quality control includes both internal controls (e.g., built-in or electronic monitors) and external controls (e.g., liquid). Although the frequency of quality control testing needs to be established by the individual lab, it should never be done less frequently than specified by the manufacturer. If controls fail, then patient results must not be reported until the discrepancy is resolved. Quality control results should be recorded each time they are performed, and the results should be periodically monitored to detect shifts or trends. Keep phone numbers for manufacturers’ technical support service, the lab director, consultants and public health labs handy for assistance in solving quality control problems.
Test performance. Follow test directions exactly as stated in the package insert or procedure manual, paying particular attention to timing. Failure to add reagents or read results within the specified time limits can produce invalid results. Consider using timers that can be attached to clothing, and keep extra timer batteries on hand.
Interpretation. Quantitative results are numerical values and do not require interpretation to report. Report the actual value, including units of measure. Qualitative results are reported as positive/negative, reactive/nonreactive, etc. Results may be compared to color charts, photographs or diagrams for interpretation.
Problem resolution. If testing produces results that are invalid, outside the measuring range of the instrument or incompatible with the patient’s clinical picture, the results should not be reported until the discrepancy is resolved. Resolution may involve repeating the test using a fresh device, referring to quality-control results or consulting with manufacturers’ technical support service.
Recording results. Results may be recorded directly in the patient chart, or in a paper or electronic logbook. Quantitative results must include the units of measure, and qualitative results should be recorded using interpretative words rather than symbols (e.g., positive/negative vs. +/−) to avoid clerical errors. Unacceptable results or repeat testing should also be recorded.
Good lab practices do not end when the test is complete. There are a number of important aspects to the post-analytic phase:
Reporting test results. Reports should be timely, legible and standardized. Verbal reports should be documented and followed by written reports. Panic values should be established for each practice, and procedures should be in place to ensure prompt communication of critical results. Labs should have a system for notifying federal and state public health agencies when a reportable disease is confirmed.
Confirmatory testing. The package insert will explain when supplemental or confirmatory testing is needed. Your lab should have procedures in place to ensure that this follow-up testing is performed. The procedure should include directions for specimen collection and handling, instructions for specimen packaging and transport if being sent to a reference lab, and a mechanism for tracking results.
Record keeping. Documentation is essential to assure quality waived testing. Documents should be easily retrievable and maintained in chronological order. Records should be maintained for the time specified by state or other regulatory agencies. You should consider keeping documentation for each item listed in “Records to maintain.” To meet CLIA requirements, most lab records should be maintained for a minimum of two years.
Quality assessment. You have two options – internal or external quality assessment. Internal assessment is a low-cost, flexible option for evaluating quality. It may be accomplished by self-inspection, review of procedures and quality control documentation. It can also be done by exchanging specimens with another lab using the same methodology and comparing results. External assessment offers extra opportunities for training and education. Arranging for inspections by peers or consultants will help you evaluate performance and quality.
Proficiency testing programs (see the list) offer an objective measure of lab performance. While voluntary for waived labs, they are strongly recommended by many state and other accreditation agencies. Proficiency testing allows you to assess your lab’s individual performance and to see how your lab is performing compared with peer groups using the same test methodologies.
Records of testing materials; test system and equipment checks; maintenance logs:
Product recall notifications
Test results, including confirmatory or supplemental results
Quality control test results and corrective action
Records of test-system failures, troubleshooting and corrective action
Records of personnel training and competency assessment
Results of proficiency testing or other external control
Better practices and health
Although the CDC recommendations lack the force of law, the power of improved quality, reduced errors and better patient health – not to mention the avoidance of possible regulatory action – should be enough to steer your in-office lab toward improvement. |
Labs who only perform waived tests
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