Hello, and welcome to Getting Started with CLIA. I'm your presenter, Bridget Smedrick. I'm the current director of CLIA Compliance for Doctors Management. I have a bachelor's in science and pre-med concentration in biology and chemistry from the University of Tennessee. I'm a certified medical technologist through the American Society of Clinical Pathology since 2000. I have over two decades of laboratory experience from physician office laboratories to high complexity laboratories, and I'm a licensed laboratory supervisor. Doctors Management is a full-service medical practice management and consulting firm. We simplify the business of medicine so that you can focus on caring for your patients and the future of your business. We advise large and small medical practices and healthcare organizations on topics such as increasing practice profits, reducing compliance risk, improving patient satisfaction, reducing stress for physicians and staff. Our team consists of nationally recognized industry experts in compliance, coding, auditing, financial services, patient retention, human resources, and more. The learning objectives for this session will be as follows. To get to know the basic aspects of CLIA, to understand the differences in CLIA certificates, to learn how to obtain a CLIA certificate, and discuss the overview of CLIA requirements. CLIA stands for the Clinical Laboratory Improvement Amendments of 1988. Its purpose is to ensure site-neutral quality of patient care. It is enforced through the Centers for Medicare and Medicaid Services. CLIA covers all laboratory testing on human specimens and healthcare settings. The exceptions to this include forensic testing and skin testing. There are five different types of CLIA certificates. The Certificate of Waiver, a Certificate of Provider Performed Microscopy Procedures, the Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation. The CLIA Certificate of Waiver. The Certificate of Waiver, or COW, covers waive tests only. Currently, there are more than 1,400 test systems listed as waived. Laboratories with a Certificate of Waiver must maintain a current certificate, pay fees every two years, follow the manufacturer instructions, and submit to inspections. However, CMS typically only inspects 2% of all waived laboratories. The survey is meant as educational and typically results in an improved laboratory environment. All laboratories who hold a Certificate of Waiver must follow the manufacturer instructions for the following topics. Specimen Collection and Handling. You can only use specimens listed as appropriate in the package insert. Quality Control. How often do you perform the quality control? Do you do it per lot, kit, shipment, new operator, every day of patient testing? All of this information is found in your package insert. Monitoring the Testing Environment, meaning you must monitor the temperature of your refrigerator or freezer if appropriate, the room temperature, and the room humidity. Your package insert also contains information on storage and handling of kits and reagents. You are not to mix lots or use any kit or reagent past its expiration date. All COLA-accredited labs are required to have written policies, procedures, competency assessments, and proficiency testing for all waived tests. Provider Performed Microscopic Procedures is a subset of non-waived complexity testing. It is not routinely inspected. The direct specimens are only to be read by a provider and a state license may be required. Procedure manuals, quality assessment plan, and competency assessments are also required for laboratories who hold this type of certificate. Your competencies are assessed using formal proficiency testing or split specimen testing. The three types of non-waived certificates include a Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation. With a Certificate of Registration, your application for non-waived testing is accepted, but your laboratory has not yet been surveyed. Some states, like New Jersey, require initial survey prior to issuing the Certificate of Registration. The second type is the Certificate of Compliance. This is a laboratory who has been successfully surveyed by CMS. Lastly, the Certificate of Accreditation. This is a laboratory who has successfully been surveyed by an agency approved by CMS, for example, COLA, CAP, or the Joint Commission. Non-waived tests fall under three different complexity levels. The Provider Performed Microscopy, Moderate Complexity, and High Complexity. Some examples of moderate complexity testing include the complete blood count, a routine chemistry, immunochemistry, throat and urine cultures, ABO and RH testing, and some test kits are actually moderate complexity instead of waived. Finally, high complexity. This includes a crossmatch, viral blood cultures, LC-MS, ID, and sensitivity for most cultures. Now let's discuss the personnel for moderate complexity laboratories. There are four different positions, the director, the clinical consultant, the technical consultant, and testing personnel. The director may be an MD, DO, or DPM with training or experience. The training may include the lab director course with 20 CMEs. Your director may also hold a BS in laboratory science plus experience, including supervisory experience. Your clinical consultant must be an MD, a DO, or PhD with board certification. Your technical consultant must hold a four-year BS degree, plus have two years of training and experience in the specialty for which you are testing. And finally, your testing personnel must hold a high school diploma or GED, plus documented training. The personnel requirements for high complexity testing are as follows. The director must be a pathologist or MD or PhD with appropriate board certification. Your clinical consultant must be an MD, DO, or PhD with the appropriate board certification. Your technical supervisor is specialty dependent, so you will need to search out someone with your particular specialty in mind. The general supervisor must have a four-year science degree, plus training and experience in your specialty. And finally, the testing personnel must hold a two-year science degree, plus lab training and experience. One thing to note is that certain specialties will have specific requirements for your testing personnel. State Laboratory Laws. CLIA requires all laboratories comply with state laboratory regulations. Some states require a laboratory license, and others have specific personnel requirements. You may contact your state CLIA office for more details. It is your responsibility to ensure the confidentiality and security of your patients. You do this by ensuring privacy, ensure availability and reliability of data. And the risks in the laboratory are as follows. Schedules that can be seen by anyone, specimens left out, terminals that have not been put into screensaver mode when you walk away, results that are faxed, and then the questions that are asked to your patient while in the phlebotomy chair. It is your responsibility to ensure the identity and integrity of your specimen throughout your testing process. This is accomplished by positive patient identification, using proper collection procedures, following and providing patient preparation instructions, using the correct container to collect your specimen, properly labeling your specimen, meaning that you use the name, medical record number, date and time of collection, and the collector's initials on each specimen, properly processing your sample, and all tests must be referred to a CLIA certified laboratory. Investigation and communication. All legitimate complaints and any breakdown in communication between the laboratory and ordering providers must be documented, investigated, and resolved. It is your responsibility to develop a system to prevent recurrence. Testing personnel competency assessments. CLIA holds the laboratory director responsible for completing all testing personnel competency assessments. However, your director may choose to delegate this task to a technical consultant. Competency is assessed via direct observation, quality control, proficiency testing, patient records, and a quiz. Competency is assessed initially before the individual begins patient testing for all COLA laboratories. At six months for all new personnel in CLIA and COLA laboratories, and at 12 months for all laboratory personnel in CLIA and COLA laboratories. This includes your technical consultant, and the competency assessment should be specific for the job responsibilities. Proficiency testing. CLIA requires that you enroll for proficiency testing for all regulated analytes. You may also choose to enroll for non-regulated analytes, but you may choose to perform split specimen testing. This is completed twice yearly using at least three specimens for each challenge. You should test your proficiency testing samples exactly as you would patient specimens. Also, all documentation should be kept for at least two years. This includes any instrument printouts and handwritten data, signed attestations, and graded reports, including any necessary corrective actions. Some of the more common errors documented for proficiency testing are as follows. Failure to inspect specimens and obtain replacements if any are found missing or damaged upon arrival. Lack of documentation of when your kit test was received. Sending your specimen more times than you would a patient specimen. Sending the specimens to or conferring with another laboratory. Failure to return all documentation, including the ID of testing personnel. Failure to return results by the deadline. And finally, a failure to self-grade if analytes were not graded. Laboratory requires a test request for all tests being performed in your laboratory. This test request may be written or electronic in nature. All verbal requests the laboratory must obtain their written order or electronic order within 30 days and must document all efforts in order to get that written order. Your test request must be ordered by an authorized individual. State law will dictate who is authorized to order tests. You must include the name of the authorized person ordering the test, who is to receive the report, and whom to contact in case of an alert value. Your test request must also include the patient's name or unique identifier, the sex and date of birth of the patient, the test to be performed, the source of the specimen, the date and time of specimen collection, along with the collector ID. Please remember also to include any information needed to ensure accurate, timely testing and reporting, including any interpretation information. CLIA requires that all laboratories have written policies and procedures surrounding specimen submission, handling, and referral. The following are topics that should be included. Instructions for patient preparation. Instructions for patient collected specimens. Proper specimen collection, meaning the order and site of draw. How to use appropriate specimen containers. How to appropriately label your specimen. How to store and preserve your specimen. How to appropriately transfer and process for referral. How to accept or reject your specimen. And finally, how to note the date and time the specimen was received in the laboratory. All CLIA certified laboratories are required to have a written procedure manual. Topics to be included in this manual are as follows. Requirements for patient preparation. Specimen collection, labeling, storage, preservation, transportation, processing, and referral, and any criteria for specimen acceptability and rejection. Instructions for the microscopic examination, including the detection of unacceptable slides. Step-by-step performance of the procedure, including any test calculations and interpretation of the results. Instructions for the preparation of slides, solutions, calibrators, controls, reagents, stains, and any other materials used in testing. Your procedure manual should also include reportable ranges for all test results, control procedures, corrective actions to take when calibration or control results fail to meet the criteria for acceptability, limitations in test methodology, including interfering substances, reference intervals, also known as normal values, panic values or medical alert values, and finally, any pertinent literature references. Test systems. CLIA allows your laboratory director, along with any pertinent laboratory staff, to choose your test system, equipment, instruments, reagents, materials, and supplies that you use to perform testing. This testing must be performed according to the manufacturer's instructions. You must monitor the following environmental conditions in order to ensure the proper functioning of each test system. Appropriate values are provided by the manufacturer. You must monitor the following, water quality, room temperature, room humidity percentage, and make sure there are no fluctuations to your electrical current. Any materials used in your laboratory, such as reagents or solutions, must be labeled to indicate the following, their identity, if applicable, the titer, the strength or concentration, all storage requirements, and the preparation and expiration dates of each solution. Your reagents and controls must not be used past their expiration date or if their integrity has been compromised. Any components of kits, such as reagents or cards, may not be combined with components of a different lot number. Your laboratory must establish and verify performance specifications of all test systems used in your laboratory. This includes non-WAVE test systems implemented after 2003, all FDA-approved test systems, new replacement or loaner test systems, and any analyte that has been added to your existing test menu. If your laboratory is using a different brand of reagents, or modified or non-FDA-approved, also known as lab-developed tests, you must also establish and verify the performance specifications of this test system. Please keep in mind that your certificate must be high complexity in order for you to make these changes. In the end, your laboratory must prove that they can meet the performance specifications set by the manufacturer. These performance specifications include accuracy, precision, reportable range, normal range, specificity, and sensitivity. You must also be able to meet personnel requirements for high-complexity testing. In order to establish and verify performance specifications, your laboratory may do the following. Run multiple specimens, on multiple shifts, on different days, with different operators. You may use commercial materials or patient specimens. Proficiency testing specimens which have already been graded may also be used for this purpose. You may use the same sample set to meet several of the requirements. Calibration requires the calibration and calibration verification of all non-waved analytes. Its purpose is to verify the accuracy throughout the reportable range. You should perform and document calibration procedures using the following criteria. Always follow your manufacturer instructions, using calibration materials provided for or specified by, and with at least the frequency recommended by your manufacturer. Use the criteria verified or established by your laboratory. Use calibration materials appropriate for the test system. And finally, include the number, type, and concentration of calibration materials, being careful to note the acceptable limits for and the frequency of your calibration. CLIA requires that your laboratory have a written procedure for how to perform calibration and calibration verification. This procedure must include actions to take whenever the calibration verification fails to meet the laboratory's acceptable limits. You must perform this calibration at least every six months, more frequently if recommended by your manufacturer. You must also perform the calibration with a complete change of your reagents, anytime you have extensive repairs or control problems. Your calibrators used must span the reportable range, low, middle, and high. Also, you must include a minimum of three specimens, although five is preferable. CLIA requires that your laboratory maintain written control procedures. Controls are used to monitor accuracy and precision of the complete analytic process, including the performance of your instrument, reagent, and operator. Control procedures are specified by the test manufacturer. For example, quantitative tests, a minimum of two levels of controls each day of patient testing is required. For qualitative tests, you must run a positive and negative control. You are required to achieve acceptable control results prior to patient testing. Controls must be performed again if maintenance is performed, if you have a complete change of your reagents, or if a part has been replaced. Across time, all operators must run controls. Controls should be treated just like patient specimens. You should also verify the integrity of your new controls on any new lot number before using them by testing in parallel with a current lot number. You should document all results and corrective actions as needed. Please remember it is important to follow your specialty-specific regulations when it comes to controls. If your laboratory is using media for culture purposes, it is important to perform the following control procedures. Check each lot and shipment for cracked petri dishes or media, unequal filling of plates, hemolysis, freezing, excessive bubbles, and contamination. You must test to verify sterility such that the media will support or suppress growth of specified bacteria. Test disc QC should be performed per shipment or lot prior to use and at least monthly. If your laboratory is performing staining procedures, you should perform a positive and negative slide on each day of patient testing. Comparison of Test Results. If your laboratory performs a test on more than one test system, you must establish how the two compare and define acceptable variances at least twice yearly. You must also identify and assess patient test results that appear inconsistent using the following criteria, patient age and gender, diagnosis, relationship with other test parameters, and distribution of patient test results. CLEAR requires that laboratories have a quality assessment plan. Quality assessment is used to evaluate the entire testing system from the pre-analytic phase all the way to post-analytic. It ensures right test results on the right patient under the correct circumstances reported in a timely manner to the authorized individual. Quality assessment ensures that from the time the provider determines a test is needed through the use of the test result for patient care, all is well. Corrective actions are required to be documented for all problems in the laboratory. You should investigate the cause, develop corrective actions, implement those corrections, verify the effectiveness of those corrective actions, find a process to prevent recurrence, and document each step. Test Records. Your laboratory must maintain records that include the following, positive identification of the specimen, the date and time of specimen receipt into the laboratory, the condition and disposition of specimens that do not meet the criteria for specimen acceptability. The records and dates of all specimen testing, including the identity of the personnel who performed the test, and all instrument printouts should be preserved. Test Reports. It requires that all laboratory test reports contain the following, patient name and unique identifier, the name and address of the testing facility, the date of testing, the tests that were performed, the source of the specimen, the unit of measure or interpretation where applicable, the normal range, and a note if the specimen was unacceptable. It's important to remember that all test reports should only be released to authorized individuals. In reviewing test reports, it's important to note that panic values must be reported immediately to the responsible healthcare professional. You should notify the ordering provider if you are unable to test within the usual timeframe. You must not alter test results from reference laboratories, and if you note any errors you should do the following, immediately notify the ordering provider, immediately issue a corrected report, and then maintain both the erroneous report and the corrected report. If your laboratory uses an LIS or Laboratory Information System, you should verify the following, that your results cross over from the analyzer correctly, that the correct results are crossing over, that these results go into the correct patient's file, and they are matched to the correct analyte. You should also verify calculations yield the correct results. All of this information is required by CLIA to be verified annually. Record Retention. Your laboratory should keep installation records for the life of the analyzer plus two years. All other records, including the following, should be kept for at least two years. The Maintenance and Service Records, Calibration and Calibration Verification Data, Quality Control Results and Quality Assessment Exercises, All Proficiency Testing Data, Patient Results, and any Corrective Actions. Surveys. Surveys will be conducted on your laboratory every two years. You normally will receive a maximum two weeks notification. You do have the opportunity prior to your notification to enter blackout dates, however this must be done in advance. The state or COLA will send forms in advance asking certain criteria to be reported to them prior to the survey, for example, your hours of operation, directions to your office, your test menu and test volumes. While conducting your survey, your surveyor will do the following, present identification, take a tour of your laboratory, review laboratory records, view certain patient records. These records may be electronic or paper charts. Please note it is not a HIPAA violation for your surveyor to review patient records. HIPAA inspectors will send or bring a business associate agreement. CLIA inspectors you may ask to sign a confidentiality agreement. Your surveyor will also look for expired items, evaluate laboratory safety, give laboratory personnel an opportunity to ask questions, and then summarize their findings. After your survey is complete, you will receive a letter outlining any deficiencies received. You must respond to this letter within 10 days. You may have additional time to complete certain corrections. You may be asked or required to submit proof of the execution of your corrections. Please remember you are required to keep all documentation until the next survey.

CLIA

Bridget Smedrick

CLIA certificates

laboratory testing

personnel requirements

manufacturer instructions