Physician office laboratory quality assurance and compliance standards
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations establish standards for all U.S. labs.
CLIA regulations set federal standards that apply to any facility performing laboratory testing on specimens obtained from humans for the purpose of providing information for health assessment or diagnosis, prevention or treatment of disease. These regulations are in place to help ensure quality is achieved so patients and physicians can be confident test results are accurate and reliable.
Learn how to obtain a CLIA certificate with this quick-start guide from CMS.
The CDC Division of Laboratory Systems focuses on improving the quality and safety of clinical and public health testing and practice. It offers resources and training opportunities.
Stay up to date on 2025 CLIA changes
Laboratory accreditation: Commission on Laboratory Accreditation (COLA)
COLA is a laboratory accrediting organization that offers discounts to AAFP members on education and services. The AAFP is a member of COLA and appoints three family physicians to serve on COLA’s board of directors, ensuring family physician perspectives influence COLA’s education programs, policies and accreditation standards.
For more information about COLA’s laboratory accreditation program, call COLA at (800) 981-9883. Let them know you are an AAFP member to receive a 10% discount on your enrollment fees.
To receive a 10% coupon code for enrollment in courses available on COLA Academy, including the Laboratory Director CME Certification Course, contact learn@cola.org.
Understanding and meeting laboratory standards
Quality assurance is an ongoing, comprehensive program that analyzes every aspect of an entire operation. It involves determining a quality goal, deciding whether or not the goal has been achieved and implementing corrective action if the goal has not been reached.
In the laboratory, quality assurance involves the entire testing process:
Preanalytical
Analytical (testing)
Postanalytical processes
Staff performance
CLIA regulations (42 CFR 493 Subpart K) address laboratory requirements and quality assurance systems. Medical decisions are made based on lab results performed in the office and at reference laboratories. Where the test is performed should not negate the significance of accurate and reliable results. Accurate test results are crucial to patient care.
Good quality assurance systems do the following:
Establish standard operating procedures for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation
Define administrative requirements, such as mandatory recordkeeping, data evaluation and internal audits to monitor adherence to standard operating procedures
Specify corrective actions, documentation and the people responsible for carrying out corrective actions when problems are identified
Ensure high-quality test performance and competency of the staff
The CDC offers information about its quality assurance programs on its website.
Steps to make a quality assurance plan
Assessing testing quality requires planned and systematic monitoring of test processes. Conducting these activities can lead to reduced errors, improved patient outcomes, improved patient and employee safety, and reduced costs. Both internal and/or external mechanisms for quality assurance may be used, depending on the needs, resources and practices of the testing site.
First: Establish laboratory procedures for each step of the test processing, including testing components such as, but not limited to:
Patient identification and order entry
Specimen collection and labeling
Transportation to the testing area
Specimen appropriateness; criteria for specimen rejection
Analytical testing process
Interpretation and accuracy of test results
Timely reporting of results
Evaluation and frequency of quality control
Actions for unexpected or failed quality control results
Instrument verification and proficiency testing (PT)
Test kits and reagent storage
Personal protective equipment and safety issues
Second: Define administrative responsibilities for laboratory management. Consider things such as:
Laboratory medical director responsibilities
Staff (office manager, lab tech, nurses and consultants) responsible for recording quality control, test kit and reagent logs, temperature logs and product recalls
Review of quality control and testing logs, including corrective steps
Periodic review of standard operating procedures
Third: Specify in writing the laboratory’s investigation plan and who will be responsible for follow-through and implementation of corrective action when problems or errors are identified. Document all quality assurance activities. As the saying goes, if it's not documented, it didn't happen.
Fourth: High-quality patient testing requires verification of staff competency and test methods employed in your medical lab.
Staff competencies
Assessment of staff competencies should verify their knowledge, skills and abilities needed to perform patient testing successfully. During the first year of employment, competency assessment is required semiannually. After the first year of employment, staff assessments should be documented and performed annually.
Competency assessment must include the following six components for each test or test platform:
Direct observation of routine patient test performance, including patient preparation (if applicable), specimen handling, processing and testing
Direct observation of instrument maintenance and function checks
Monitoring of test results reporting
Review of records (i.e., test results, worksheets, quality control records, PT results, maintenance records)
Assessment of test performance (i.e., PT, blind sample testing)
Assessment of problem-solving skills (e.g., evaluation of problem and action logs, quality control corrective action, specimen rejection events, written quiz)
CLIA does not require competency assessment of staff for waived testing; however, ensuring accurate results is essential to make the correct patient diagnosis. Assessments are necessary to ensure staff are following the manufacturer’s instructions. Keep in mind that any variation from the manufacturer’s instructions for waived tests will negate the waived status and the test will be subject to all regulations as a moderate complexity test.
Laboratories with provider-performed microscopy (PPM) certificates are required to meet competency assessment in all six components. All testing personnel in PPM laboratories are required to have annual competency assessment.
CMS provides detailed information on assessing staff competency.
Method verification of test procedures
Method verification of test procedures is required to ensure, by objective evidence, that the instrument or test method consistently provides accurate patient results. Method verification must be completed before reporting your first patient test result. CMS has published a guide for verifying performance specifications to help navigate this regulation.
When should method verification be performed?
- When new tests or analytes are introduced into the medical laboratory, including adding analytes to an existing test system
- When a new test kit or instrument is introduced into the medical laboratory
- When a medical practice or laboratory instrumentation is relocated (e.g., instrument used at the office in building A moves to a new office in the same building or to building B)
Who is responsible for ensuring verification is completed and meets the criteria?
The technical consultant/supervisor and/or laboratory director are responsible for ensuring procedures for verifying performance are adequate, defining criteria for acceptance and evaluating the results generated during the verification process. Laboratory testing staff must participate in the verification process since they will be performing the tests on patient samples.
What performance specifications does verification include?
- Accuracy
- Precision
- Reportable range
- Normal values or range for the laboratory patient population
How is test verification most commonly accomplished?
- Previously tested patient specimens with known values
- Split sampling of patient specimens
- Commercial material with known values, such as calibrators
- Proficiency testing
These materials can be used in multiple ways to verify accuracy, precision and reportable range. The number of specimens needed for each analyte and for each part of the verification process may vary. The laboratory director and technical consultant/supervisor are responsible for determining the appropriate number of samples. As a rule of thumb, use 20 specimens that span the reportable range for quantitative analytes. For qualitative analytes, use five positive and five negative specimens.
Laboratory errors
Most laboratory errors occur in the preanalytical and postanalytical phases, while less than 10% of all errors happen during the testing or analytical phase. Establishing robust processes to ensure quality patient results is the primary purpose of having a quality assurance plan.
The most vulnerable (i.e., prone to errors) aspects of the preanalytical phase of testing are proper patient identification, good-quality specimen collection, timely transport and appropriate physician order. Delays in reporting and incorrect data entry are the most common errors in the postanalytical phase.
A well-prepared procedure manual provides a foundation for the lab’s quality assurance program. Its purpose is to ensure consistency while striving for quality.
The procedure manual may be used to:
Document how tests are performed
Train new personnel
Remind personnel how to perform infrequently ordered tests
Troubleshoot testing problems
Measure acceptable test performance when evaluating staff
The procedure manual should be written at a level that everyone in the laboratory can understand. It must be useful, clear to the user and available at the bench/work area.
All testing personnel should be required to read the entire procedure manual. It is advisable to include a page at the front of the manual where personnel can sign off, indicating when they have read the manual. An annual review would benefit the lab personnel and could be included as part of the overall quality assurance program.
Include a general policies section addressing lab-specific issues, such as:
The lab’s quality assurance plan
Specimen collection
Specimen labeling
Form completion
Panic value list
Guidelines for releasing results
CLIA requirements
All labs must have a written procedure manual that covers all tests performed in the lab. The manual must be readily available and followed by laboratory personnel. Textbooks may be used in addition to the procedure manual.
The following information must be included:
Specimen collection, processing and rejection criteria requirements
Procedures for microscopic examinations, including the detection of inadequately prepared slides
Step-by-step performance of the procedure, including test calculations and interpretation of results
Preparation of slides, solutions, calibrators, controls, reagents, stains and other materials used in testing
Calibration and calibration verification procedures
The reportable range of patient test results as established or verified through method performance specifications
Control procedures
Remedial action to take when calibration or control results fail to meet the lab’s criteria for acceptability
Limitations in methodologies, including interfering substances
Reference or normal ranges
Imminent life-threatening lab results or panic (critical) values
Pertinent literature references
Appropriate criteria for specimen storage and preservation to ensure specimen integrity until testing is completed
The lab’s system for reporting patient results, including, when appropriate, the protocol for reporting panic values
Description of the steps to be taken if a test system becomes inoperable
Criteria for the referral of specimens, including procedures for specimen submission and handling
Source: 42 CFR 493 Subpart K, 493.1251
Manufacturer’s package inserts or operator manuals may be used to meet the requirement; any information not included by the manufacturer must be included by the laboratory. All procedures must be approved, signed and dated by the laboratory director. Procedures must be reapproved, signed and dated if the director of the laboratory changes; each change must be approved, signed and dated by the current laboratory director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance, retaining records for two years after the procedure has been discontinued.
Tips for a useful manual
Preparing the procedure manual is typically the most time-consuming part of developing a quality assurance program. It is worth a little extra effort to ensure the manual is useful. The lab’s needs and organization should determine the procedure manual’s design.
Some tips include:
Use a three-ring binder to maintain the document in a format that is easily reviewed and updated.
Use a computer for word processing to simplify the process, if possible.
Start each procedure on a new page or in a new file for ease in making changes.
Use tabs or a table of contents for easy reference.
Use plastic page protectors to extend the shelf life of the manual.
In a physician office laboratory (POL) with limited space, it is helpful to use a card index system as a supplement to the procedure manual. This system is an abbreviated form; it should contain the first six elements listed above. A copy of each card should be included in the actual procedure manual.
Sources:
- Hoetge GA, et al. Clinical Laboratory Technical Procedure Manuals. 3rd ed. GP2-A3. National Committee for Clinical Laboratory Standards; 1996.
- Laessig RH, Ehrmeyer SS. The New Poor Man’s (Person’s) Guide to the Regulations: CLIA ’88, JCAHO, CAP & COLA. Colorado Association for Continuing Medical Laboratory Education; 2001.
The difference between waived and PPM tests
Waived tests employ methodologies so accurate and straightforward as to render the likelihood of erroneous results very low when the manufacturer’s procedure is followed. However, even if a test is approved by the FDA for waived or home testing, that does not mean it is completely error-proof. Errors can still occur at any stage of the testing process, particularly when manufacturer instructions are not followed or when testing personnel are not familiar with all aspects of the test system.
These tests pose no reasonable risk of harm to the patient if performed incorrectly. However, some waived tests do have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in people with diabetes. In addition, erroneous results from diagnostic tests, such as those for HIV antibody, can have unintended consequences. To decrease the risk of inaccurate results, the test needs to be performed correctly by trained personnel and in an environment where good laboratory practices are followed.
Offices wanting only to perform waived tests must apply for a certificate of waiver.
PPM procedures
PPM procedures are a select group of moderately complex microscopy tests commonly performed by licensed health care professionals during patient office visits. Tests included in PPM procedures do not meet the criteria for waiver because they are not simple procedures; they require training and specific skills for test performance. A CLIA certificate for PPM procedures allows physicians, non-physician clinicians (i.e., nurse practitioners, nurse midwives and physician assistants) and dentists to perform certain moderate complexity microscopic examinations, in addition to waived testing, during patient visits.
The laboratory or testing site performing PPM procedures is not subject to routine biennial inspections. However, a CLIA certificate is required, and the laboratory or testing site must meet the CLIA quality standards for moderate complexity testing.
Sites performing PPM procedures must file for a certificate for PPM procedures and obtain a separate certificate for each location.
Other key notes about PPM
A. Allowed microscopic exams using bright field or phase-contrast microscopy include:
All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites and human cellular elements
All potassium hydroxide preparations
Pinworm examinations
Fern tests
Urine sediment examinations
Nasal smears for granulocytes
Fecal leukocyte examinations
Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility)
Postcoital direct, qualitative examinations of vaginal or cervical mucus
B. The specimens for these procedures deteriorate quickly. A delay in performing the test could compromise the accuracy of the test result. Therefore, it is recommended that PPM procedures be performed during the course of the patient visit.
C. Quality control is required when it is available; control material is available for urine sediments.
D. PPM tests are considered nonregulated. PT is not explicitly required, but a laboratory is responsible for documenting quality assurance. For more guidance, see the CDC’s booklet on quality practices for PPM procedures.
E. Several CLIA-approved PT programs offer modules for PPM, and participation in a clinical microscopy or PPM PT module will satisfy the biannual alternative competency assessment requirement. If laboratories or testing sites enroll in PT, they are subject to all requirements for PT, including the prohibition of PT referral.
F. Laboratories with an inspecting agency other than CMS and/or state agencies should contact their inspecting agency to inquire about their specific requirements.
G. 42 CFR 493 (Oct. 2001) indicates that PPM laboratories are subject to Subparts H (PT), J (patient test management), K (quality control), M (personnel) and P (quality assurance).
H. CDC: PPM procedures
Test your knowledge of waived and PPM labs
True or false?
Quality control is never required on waived tests.
Once the testing personnel review the manufacturer's instructions for a test, it is not necessary to review them again.
Documented training is not required of testing personnel in a waived lab.
A waived lab can perform complete blood count tests if the test is not billed.
Quality assurance is not required for PPM labs.
The correct answer to all of these questions is “False.” Being a CLIA-waived or PPM lab does not mean there aren't specific regulatory criteria to which the POL must adhere.
Under the CLIA regulations, POLs with a certificate of waiver may perform only those tests that have been classified as waived. During the course of a patient visit, POLs with a PPM certificate may perform tests using a microscope on specimens that are not easily transportable, along with the waived tests.
CLIA requires waived labs to:
Enroll in the CLIA program
Pay applicable certificate fees biennially
Follow manufacturers' test instructions
The number and types of tests waived under CLIA have increased from eight tests to approximately 40 since the inception of the program in 1992. As a result, the number of waived labs has grown exponentially from the total 171,000 laboratories enrolled.
CLIA requires PPM labs to:
Enroll in the CLIA program
Pay applicable certificate fees biennially
Address certain quality and administrative requirements
Checklist for waived and PPM testing compliance
Waived labs:
Use the most recent package insert of the manufacturer's instructions. Kit instructions may change slightly from lot to lot; date the insert with the date the shipment was received as documentation.
Perform quality control and/or calibration as specified by the kit manufacturer. Most of the test kits receiving waived status after the publication of the CLIA regulations have specific quality control requirements. Maintain the quality control documentation for two years.
Use the test kits and reagents in their original form. Do not alter reagent strips by cutting them to test more samples per strip.
Store and handle all test kits according to the manufacturer's instructions.
Never use outdated reagents.
Document training of all testing personnel in their personnel file. Training for each test and test method is required. Update the training records whenever a test method changes (either the method or the manufacturer).
Inform the POL's surveying agency of any change in the status of the lab (e.g., change in the medical director, practice name or address). Monitor room and refrigerator temperatures.
Follow all Occupational Safety and Health Administration (OSHA) regulations that pertain to laboratory testing (e.g., bloodborne pathogens regulations).
PPM labs (in addition to the checklist for waived testing):
Perform either PT or quality assurance (i.e., split sampling or an external quality assurance program) at least two times per year for documentation of the accuracy of the procedures.
Perform and document microscope and centrifuge maintenance (daily or when tests are performed).
Develop and maintain a current procedure manual for all microscopy tests performed in the lab.
Perform and document personnel competency (through quality assurance testing or other educational material for microscopy testing).
Inform the POL's surveying agency of any change in the status of the lab (e.g., change in the medical director, practice name or address).
Follow all OSHA regulations that pertain to laboratory testing (e.g., bloodborne pathogens regulations).
Effective December 28, 2024, CLIA regulations require a nonpathologist physician to both:
Have at least one (or two*) year(s) directing or supervising nonwaived laboratory testing AND
Complete 20 continuing education credit hours in laboratory director duties
The CLIA personnel requirements are found in 42 CFR 493 Subpart M. This subpart addresses qualifications and responsibilities for PPM, moderate complexity and high complexity laboratories. Laboratories performing only waived testing do not have specific personnel qualifications. However, waived laboratories need oversight to achieve quality patient testing consistently. The individual designated for oversight should have the technical knowledge and experience to problem-solve testing issues and provide support to testing personnel.
Requirements for a moderate complexity lab
A moderate complexity laboratory is required to have personnel who meet the following qualifications (Note: In most situations, the laboratory director is qualified to fulfill multiple roles.):
Laboratory director qualifications:
MD/DO/DPM certified in anatomic or clinical pathology*
An individual with a PhD/DCLS degree in a field such as biology, chemistry, clinical laboratory science, medical technology or medical laboratory science* must also have:
Current board certification from a Department of Health and Human Services-approved entity
One year of experience directing or supervising nonwaived testing
20 hours of continuing education credit in laboratory director duties
An MD/DO/DPM not certified in pathology* must also have:
One year of experience directing or supervising nonwaived testing
20 hours of continuing education credit in laboratory director duties
An individual with a master’s degree in a field such as biology, chemistry, clinical laboratory science, medical technology or medical laboratory science must also have:
One year of nonwaived laboratory experience or training
One year of experience directing or supervising nonwaived testing
20 hours of continuing education credit in laboratory director duties
An individual with a bachelor’s degree in a field such as biology, chemistry, clinical laboratory science, medical technology or medical laboratory science must also have:
Two years of nonwaived laboratory experience or training
Two years of experience directing or supervising nonwaived testing
20 hours of continuing education credit in laboratory director duties
Degrees in fields other than the aforementioned may require transcripts so applicable coursework can be evaluated and approved.
The laboratory director is responsible for the laboratory’s total compliance, even if responsibilities are delegated to others.
*Laboratory directors of high complexity laboratories must have two years of experience directing high complexity testing (versus one year of experience needed for moderate complexity testing). See the Federal Register for more details if needed.
Technical consultant
The laboratory must have a technical consultant qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties tested in the laboratory.
Qualifications include:
Possess a current license issued by the state in which the laboratory is located, if such licensing is required
AND
Be a licensed MD or DO practicing in the state where the laboratory is located and be certified in anatomic pathology, clinical pathology or both by the American Board of Pathology or the American Osteopathic Board of Pathology, or hold equivalent qualifications
OR
Be an MD, DO or DPM licensed to practice medicine, osteopathy or podiatry in the state in which the laboratory is located and have at least one year of laboratory training, experience or both in nonwaived testing in the designated specialty or subspecialty areas of service for which the technical consultant is responsible
OR
Hold a doctoral or master’s degree in a chemical, physical, biological or clinical laboratory science or in medical technology from an accredited institution and have at least one year of laboratory training, experience or both in nonwaived testing in the designated specialty or subspecialty areas of service for which the technical consultant is responsible
OR
Have earned a bachelor’s degree in a chemical, physical or biological science or in medical technology from an accredited institution and have at least two years of laboratory training, experience or both in nonwaived testing in the designated specialty or subspecialty areas of service for which the technical consultant is responsible
Clinical consultant
The clinical consultant must be qualified to consult with and render opinions to the laboratory’s clients concerning diagnosis, treatment and management of patient care.
Qualifications include:
Be qualified as the laboratory director
OR
Be an MD, DO or DPM and possess a license to practice medicine, osteopathy or podiatry in the state in which the laboratory is located
Testing personnel
The laboratory must have a sufficient number of individuals who meet the qualifications to perform the volume and complexity of tests performed.
Qualifications include:
Possess a current license issued by the state in which the laboratory is located, if such licensing is required
AND
Be an MD, DO or DPM licensed to practice medicine, osteopathy or podiatry in the state in which the laboratory is located or have earned a doctoral, master’s or bachelor’s degree in a chemical, physical, biological or clinical laboratory science or in medical technology from an accredited institution
OR
Have earned an associate degree in a chemical, physical or biological science or in medical laboratory technology from an accredited institution
OR
Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks' duration and have held the military enlisted occupational specialty of medical laboratory specialist (laboratory technician)
OR
Have earned a high school diploma or equivalent and have documentation of training appropriate for the testing performed before analyzing patient specimens
Such training must ensure the individual has:
The skills required for proper specimen collection, including patient preparation (if applicable), labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens
The skills required for implementing all standard laboratory procedures
The skills required for performing each test method and for proper instrument use
The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed
A working knowledge of reagent stability and storage
The skills required to implement quality control policies and procedures of the laboratory
An awareness of the factors influencing test results, along with the necessary skills to assess and verify the validity of patient test results through the evaluation of quality control sample values before reporting
CLIA inspection regulations are found in 42 CFR 493 Subpart Q, which addresses both basic and specific inspection requirements. All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements.
CMS' policy for inspections includes announced initial and biennial recertification inspections and unannounced complaint and follow-up inspections. The process focuses more on outcomes as opposed to processes. CMS' objectives in developing an outcome-oriented survey process were to not only determine the laboratory's regulatory compliance but also to assist laboratories in improving patient care by emphasizing those aspects that have a direct impact on the laboratory's overall test performance. CMS promotes the use of an educational survey process.
Basic inspection requirements
Laboratories are required to permit CMS or its representatives to conduct an inspection. CLIA-exempt and accredited laboratories must permit validation and complaint inspections.
As part of the process, laboratories may be required to:
Test samples, including PT, or perform procedures
Permit interviews of all personnel concerning the laboratory's compliance
Permit personnel to be observed performing all phases of the testing process
Permit CMS or its representatives to access all areas encompassed under the certification, including, but not limited to:
• Specimen procurement and processing areas
• Storage facilities for specimen reagents, supplies, records and reports
• Testing and reporting areasProvide CMS or its representatives with copies or exact duplicates of all records and data it requires
A laboratory must have all records and data accessible and retrievable within a reasonable amount of time during the inspection. Further, a laboratory must provide (upon request) all information and data necessary for CMS or its representatives to make a determination of the laboratory's compliance. CMS or its representatives may reinspect a laboratory at any time to evaluate the laboratory's ability to provide accurate and reliable test results.
Note: CMS or its representatives may conduct an inspection when there are complaints alleging noncompliance with the regulations. Failure to permit an inspection of any type results in suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment, as well as suspension or limitation of the laboratory's CLIA certificate or action to revoke it.
Waived and PPM laboratories
While laboratories issued a certificate of waiver or certificate for PPM are not subject to biennial inspections, CMS or its representatives may conduct inspections at any time during the laboratory's hours of operation to:
Determine if the laboratory is operated and performs testing in a manner that does not constitute an imminent and serious risk to public health
Evaluate a complaint from the public
Determine whether the laboratory is performing tests beyond the scope of its certificate
Collect information regarding the appropriateness of tests specified as waived or PPM
Waived and PPM laboratories must comply with all of the basic inspection requirements.
Certificate of compliance
Laboratories issued a registration certificate must permit an initial inspection to assess the laboratory's compliance with the regulations before issuance of a certificate of compliance. These inspections may occur at any time during the laboratory's hours of operation and may include review of PPM testing. CMS or its representatives may conduct subsequent inspections on a biennial basis or with such frequency as necessary to ensure compliance.
Subsequent inspections are based on compliance history. Laboratories demonstrating CLIA compliance—based on type and number of deficiencies cited previously, PT performance, and number and types of complaints lodged—are given the opportunity to participate in the Alternative Quality Assessment Survey, which is a self-survey document. This option is available every other survey cycle (a two-year period).
Accredited and CLIA-exempt laboratories
CMS or its representatives may conduct validation and complaint investigation inspections of any accredited or CLIA-exempt laboratory at any time during its hours of operation.
Should an accredited laboratory fail to comply with one or more condition-level requirements, it is subject to a full review by CMS.
Should a CLIA-exempt laboratory fail to comply with one or more condition-level requirements, it is subject to appropriate enforcement actions under the approved state licensure program.
Along with stipulating qualifications, the CLIA regulations specify the expected duties of the laboratory director. The director has the responsibility for the overall administration and operation of the laboratory, including hiring personnel who are competent to perform laboratory testing and record/report test results promptly, accurately and proficiently.
The director is also responsible for ensuring compliance with the regulations. Regulations related to the director are contained in 42 CFR 493 Subpart M, along with those for the technical consultant, clinical consultant and testing personnel. The laboratory director must be accessible to the laboratory to provide on-site, telephone or electronic consultation, as needed. CLIA requires a laboratory director to be on site at least once every six months, with at least four months between the visits. Each visit must be documented with supporting evidence of the lab director’s duties being performed.
A person may direct no more than five laboratories. If qualified, the laboratory director may perform the duties of the technical consultant, clinical consultant and testing personnel, or they may delegate these responsibilities to personnel meeting the appropriate qualifications. If the laboratory director reassigns performance of their responsibilities, they remain responsible for ensuring all duties are properly performed.
Duties for directing a moderate complexity laboratory include:
Ensure systems used for testing provide quality laboratory services for all phases of testing (including preanalytic, analytic and postanalytic)
Ensure the laboratory facilities (i.e., physical setting, environmental conditions) are suitable for the tests being performed and provide a safe work area in which employees are protected from physical, chemical and biological hazards
Ensure the laboratory’s test systems have the capability of providing the quality results necessary for patient care
Ensure verification procedures used are adequate to determine the accuracy, precision and other applicable performance characteristics of the method
Ensure laboratory personnel are performing the test methods as required for accurate and reliable results
Ensure the laboratory is enrolled in a Department of Health and Human Services-approved PT program
Make certain samples are tested as required in 42 CFR 493 Subpart H
Make certain the results are submitted within the timeframe determined by the PT provider
Make certain the appropriate staff reviews all reports to evaluate the laboratory’s performance and identify problems that require corrective action
Make sure an approved corrective action plan is completed when PT results are unacceptable or unsatisfactory
Ensure the quality control and quality assurance programs are developed and maintained to ensure quality testing and to identify failures in quality as they occur
Ensure acceptable standards of testing performance are established and maintained
Ensure corrective actions are taken and documented whenever deviations from performance standards are identified and that patient test results are reported only when the testing is functioning properly
Ensure test result reports include pertinent information required for interpretation (i.e., reference ranges, panic values)
Ensure consultation is available to clients (i.e., other physicians in the practice) in the area of quality of the test results reported and interpretation concerning patient conditions
Employ a sufficient staff with the required education, experience and training to provide consultation, supervision, and test performance and reporting in accordance with the regulations
Ensure all staff have the required education and experience and have received the appropriate training for the testing being performed before testing. The staff must be able to demonstrate they can perform the testing and reliably report accurate results.
Ensure policies and procedures have been established for monitoring staff who perform preanalytic, analytic and postanalytic steps to ensure they are competent to process, test and report results of test procedures
When necessary, identify needs for additional training and/or continuing education to improve skills
Ensure an approved procedure manual is available to all office personnel who are responsible for any phase of testing
Specify in writing the responsibilities and duties for each person involved with any aspect of testing
Document which tests each individual is authorized to perform, whether or not supervision is required and whether a consultant or director review is required before reporting results
Source: 42 CFR 493 Subpart M, 493.1407
PT record retention requirements
| Laboratory record | Period of retention |
| PT results (copies of what was submitted to the PT provider) | 2 years |
| Attestation statement | 2 years |
| PT evaluations | 2 years |
| All other PT-related forms | 2 years |
Test record retention requirements
| Laboratory record | Period of retention |
| Test requisitions | 2 years |
| Test records | 2 years |
| Test reports | 2 years |
| Immunohematology | 2 years |
Quality control record retention requirements
| Laboratory record | Period of retention |
| Discontinued procedures | 2 years |
| Method performance specifications | 2 years |
| Equipment maintenance and function checks | 2 years |
| Calibration and calibration verification | 2 years |
| Control procedures (e.g., daily quality control records) | 2 years |
| Remedial action—errors in reported results (the original and corrected report) | 2 years |
Before your laboratory can perform any testing, your practice must obtain the appropriate CMS CLIA certification.
CLIA, which CMS, the FDA and the CDC administer, regulates the quality and safety of U.S. clinical laboratories to ensure the accuracy, reliability and timeliness of patient test results, regardless of where the test was performed. CLIA has regulatory requirements for quality that all laboratories must meet.
Certificate type is based on the highest level of test complexity performed by a laboratory.
Laboratories can apply for one of the following:
- Certificate of waiver: Simple tests or examinations with low risk for erroneous results are known as waived tests. Tests must be performed according to the manufacturer’s instructions without variation to meet the CLIA certificate of waiver criteria.
- Certificate for PPM procedures: This is a subset of moderate complexity tests performed by a physician or non-physician clinician. PPM procedures consist of specific microscopy examinations performed during a patient’s visit.
- Certificate of compliance or accreditation: Laboratories performing moderate and/or high complexity tests can choose either the compliance or accreditation certificate based on the agency that surveys the laboratory for compliance with CLIA regulations.
A certificate of compliance is issued to a lab after an inspection by the state agency if it is found to be in compliance.
A certificate of accreditation is issued to a lab after an inspection by a CMS-approved nonprofit accreditation organization, such as COLA, if it is found to be in compliance with CLIA regulations.
Have questions about applying for a CLIA certificate or filling out the application?
Visit the CMS website.
Download the CMS CLIA certification quick-start guide.