Meeting Clinical Laboratory Improvement Amendments (CLIA) Regulation Standards in Your Practice

Quality assurance is an ongoing, comprehensive program which 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:

• pre-analytical
• analytical (testing)
• post-analytical processes 
• staff performance. 

The CLIA regulations (Subpart K) addresses 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 include the following:                 

1. Establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation;
2. Defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs;
3. Specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified; and
4. Assure high-quality test performance and competency of the staff.

For information from CDC’s Lab Standards webpage, visit Laboratory Quality Assurance and standardization Programs.

Making a Quality Assurance Plan

Assessing testing quality requires planned and systematic monitoring to 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 testing processing, include components of testing such as, but not limited to:

• Patient identification & order entry
• Specimen collection & labeling
• Transportation to testing area
• Specimen appropriateness, criteria for specimen rejection
• Analytical testing process
• Interpretation & accuracy of test result
• Timely reporting of results
• Evaluation and frequency of quality control (QC)
• Actions for unexpected/failed QC results
• Instrument verification and proficiency testing
• Test kits and reagent storage
• Personal protective equipment (PPE) and safety issues

Second: Define administrative responsibilities to laboratory management. Consider things such as:

• Laboratory medical director responsibilities 
• Staff (office manager, lab tech, nurses, and consultants) responsibilities for recording QC, test kit and reagent logs, temperature logs, and product recalls
• Review of quality control and testing logs, include corrective steps
• Periodic review of SOPs

Third: Specify, in writing, laboratory’s investigation plan and who will be responsible for follow through and implementation of correction action when problems or errors are identified. Document all quality assurance activities. As the saying goes, if it is not written down, it didn’t happen.

Fourth: High-quality patient testing requires verification of staff competency and test methods employed in your medical lab.

Staff Competencies

Staff competencies should assess their knowledge, skills and abilities needed to perform patient testing successfully. Staff assessments should be documented and performed annually after the first year of employment. During first year of employment, competency assessment is required semiannually.  

Competency assessment must include the following 6 components for each test or test platform:

1. Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing
2. Direct observation of instrument maintenance and function checks
3. Monitoring test results reporting
4. Review of records- i.e., test results, worksheets, quality control (QC) records, proficiency testing results, and maintenance records
5. Assessment of test performance- i.e., proficiency testing, blind sample testing
6. Assessment of problem-solving skills- e.g., evaluate problem/action logs, QC corrective action, specimen rejection events, or written quiz

CLIA does not require competency assessment of staff for waived testing, however ensuring accurate results is essential to make the right patient diagnosis. Staff assessments are necessary to ensure staff are following manufacturers’ instructions. Keep in mind, any variation from manufacturer’s instructions of waived tests will negate waived status and test will be subject to all regulations as a moderate complex test.

Laboratories with provider-performed microscopy (PPM) certificates are required to meet competency assessment in all 6 components. All testing personnel in PPM laboratories are required to have annual competency.

For detailed information from CMS regarding staff competency, visit CMS brochure What Do I Need to Do to Assess Personnel Competency.

Method Verification of Test Procedures

Method verification of test procedures is required to ensure, by objective evidence, the instrument or test method consistently provides accurate patient results Method verification must be completed prior to reporting your first patient test result. CMS has a published guide for Verification of Performance Specifications to help navigate this regulation.

When should method verification be performed?

• New test(s) or analytes introduced into the medical laboratory. This includes adding analytes to an existing test system.
• New test kit or instrument introduced into the medical laboratory.
• Relocation of medical practice or laboratory instrumentation. (e.g., instrument used at office in building A moves to new office same building A or new building (B))

Who is responsible for ensuring verification is completed and meets criteria?

• The Technical Consultant/Supervisor and/or Laboratory Director are responsible for ensuring procedures for verifying performance is adequate, defining criteria for acceptance, as well as evaluating the results generated during the verification process. Laboratory testing staff must participate in the verification process as they will be performing the tests on patient samples.  

What performance specifications are included in verification?

• Accuracy
• Precision
• Reportable Range
• Normal values or range for the laboratory patient population

How is test verification most commonly accomplished?

• Proficiency testing
• Previously tested patient specimens with known values
• Split sampling of patient specimens
• Commercial material with known values, such as calibrators

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, 20 specimens spanning the reportable range for quantitative analytes. Five positive and five negative specimens for qualitative analytes.

Laboratory Errors

Most laboratory errors occur in the pre and post analytical phases, while less than 10% of all errors happen during the testing or analytical phase. Establishing robust processes to ensure quality patient results are obtained every time is the whole purpose of having a quality assurance plan.

The most vulnerable components in the pre-analytical phase of testing and prone to errors are proper patient identification, good quality specimen collection, timely transport, and appropriate physician order. While timeliness in reporting and incorrect data entry are most prone errors in the post analytical phase.

The Difference Between Waived and PPM Tests

Waived tests are defined to employ methodologies so simple and accurate as to render the likelihood of erroneous results is very low when manufacturer procedure is followed. However, with the advancement of technologies, tests that are FDA approved for waived or home testing, does not mean waived tests are completely error-proof. They pose no reasonable risk of harm to the patient if the test is performed incorrectly, and they are cleared by the Food and Drug Administration for home use. Errors can occur anywhere in the testing process, particularly when the manufacturer’s instructions are not followed and when testing personnel are not familiar with all aspects of the test system.

Some waived tests 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 diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. To decrease the risk of erroneous 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 (COW). 

Provider Performed Microscopy (PPM)

Provider-performed microscopy (PPM) procedures are a select group of moderately complex microscopy tests commonly performed by licensed health care providers 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, midlevel practitioners (i.e., nurse practitioners, nurse midwives, and physician assistants) and dentists to perform certain moderate complexity microscopic examinations in addition to waived testing during a patient’s visit.

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:

1. All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements
2. All potassium hydroxide (KOH) preparations
3. Pinworm examinations
4. Fern tests
5. Urine sediment examinations
6. Nasal smears for granulocytes
7. Fecal leukocyte examinations
8. Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility)
9. Post-coital direct, qualitative examinations of vaginal or cervical mucous

B.    The specimens for these procedures deteriorate quickly or delay in performing the test could compromise the accuracy of the test result, therefore recommended to 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 non-regulated, proficiency testing (PT) is not specifically required, but a laboratory is responsible for documenting quality assurance. For more guidance read the PPM Procedures: A Focus on Quality Practices booklet authored by CDC.

E.     Several CLIA-approved PT programs offer modules for PPM and participation in a clinical microscopy or PPM PT module will satisfy the bi-annual 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.     Those laboratories with an inspecting agency other than CMS/state agencies should contact their inspecting agencies to inquire about their specific requirements.

G.    The 42 CFR 493- October 2001 indicates that PPM laboratories are subject to Subparts H (Proficiency Testing), J (Patient test Management), K (Quality Control), M (Personnel), and P (Quality Assurance).

H.    CDC: Provider-Performed Microscopy (PPM) Procedures

Effective December 28, 2024, CLIA regulations require a non-pathologist physician to:

• Have at least one (or two*) year directing or supervising non-waived laboratory testing 
• AND complete 20 CE credit hours in laboratory director duties 

The CLIA personnel requirements are found in Subpart M of the Code of Federal Regulations. This subpart addresses qualifications and responsibilities for provider performed microscopy (PPM), moderate complexity, and high complexity laboratories. Laboratories performing only waived testing do not have specific personnel qualifications.

However, waived laboratories need oversight to consistently achieve quality patient testing. 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 (in most situations, the laboratory director is qualified to full multiple roles):

Laboratory Director Qualifications

MD/DO/DPM certified in anatomic or clinical pathology* 

PhD/DCLS degree in fields such as biology, chemistry, clinical laboratory science, medical technology (MT), or medical laboratory science (MLS),*  the individual must also:

• Hold current board certification from an HHS approved entity
• Have one year of experience directing or supervising non-waived testing
• Earned 20 hours of continuing education in laboratory director duties

MD/DO/DPM not certified in pathology* must also:

• Have one year of experience directing or supervising non-waived testing
• Earned 20 hours of continuing education in laboratory director duties

Master’s degree in fields such as biology, chemistry, clinical laboratory science, medical technology (MT), or medical laboratory science (MLS), the individual must also:

• Have one year of non-waived laboratory experience or training
• Have one year of experience directing or supervising non-waived testing
• Earned 20 hours of continuing education in laboratory director duties

Bachelor’s degree in fields such as biology, chemistry, clinical laboratory science, medical technology (MT), or medical laboratory science (MLS), the individual must also:

• Have two years of non-waived laboratory experience or training
• Have two years of experience directing or supervising non-waived testing
• Earned 20 hours of continuing education in laboratory director duties

Degrees in fields other than those aforementioned may require transcripts so applicable coursework can be evaluated and approved. 

Laboratory directors are 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 (verses 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. The qualifications include:

• Possess a current license issued by the state in which the laboratory is located, if such licensing is required.

AND

• Be a doctor of medicine or osteopathy licensed to practice medicine or osteopathy in the state in which the laboratory is located and be certified in anatomic, clinical pathology, or both by the American Board of Pathology or the American Osteopathic Board of Pathology, or possess qualifications that are equivalent.

OR

• Be a doctor of medicine, osteopathy, or doctor of podiatric medicine 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 or experience or both in non-waived 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 medical technology from an accredited institution, and have at least one year of laboratory training or experience or both in non-waived 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 medical technology from an accredited institution, and have at least two years of laboratory training or experience or both in non-waived 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 the diagnosis, treatment, and management of patient care. The qualifications include:

• Be qualified as the laboratory director.

OR

• Be a doctor of medicine, osteopathy, or podiatric medicine 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 a doctor of medicine, osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, 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 medical technology from an accredited institution.

OR

• Have earned an associate degree in a chemical, physical, or biological science or 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 prior to analyzing patient specimens. Such training must ensure that 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, and
  • The skills required for implementing all standard laboratory procedures, and
  • The skills required for performing each test method and for proper instrument use, and
  • The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed, and
  • A working knowledge of reagent stability and storage, and
  • The skills required to implement quality control policies and procedures of the laboratory, and
  • An awareness of the factors that influence test results, and the skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.

Along with stipulating qualifications, the CLIA regulations specify the expected of duties for 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 assuring compliance with the regulations. The regulations related to the director are contained in 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 lab director 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 delegate these responsibilities to personnel meeting the appropriate qualifications. If the laboratory director reassigns performance of his/her responsibilities, he/she remains responsible for ensuring all duties are properly performed. Duties for directing a moderate level laboratory include:

• Ensure that systems used for testing provide quality laboratory services for all phases of testing (including preanalytic, analytic, and postanalytic).
• Ensure that the laboratory facilities (physical setting and environmental conditions) are suitable for the tests being performed and provide a safe work area in which employees are protected from physical, chemical, and biologic hazards.
• Ensure that the laboratory’s test systems have the capability of providing the quality results necessary for patient care.
• Ensure that verification procedures used are adequate to determine the accuracy, precision, and other applicable performance characteristics of the method.
• Ensure that laboratory personnel are performing the test methods as required for accurate and reliable results.
• Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program and make certain that:
  • Samples are tested as required in Subpart H.
  • The results are submitted within the timeframe determined by the PT provider.
  • All reports are reviewed by the appropriate staff to evaluate the laboratory’s performance and identify problems that require corrective action.
  • An approved corrective action plan is completed when PT results are unacceptable or unsatisfactory.
• Ensure that the quality control and quality assurance programs are developed and maintained to assure quality testing and to identify failures in quality as they occur.
• Ensure that acceptable standards of testing performance are established and maintained.
• Ensure that 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 that test result reports include pertinent information required for interpretation (i.e., reference ranges, panic values, etc.).
• Ensure that 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/reporting in accordance with the regulations.
• Ensure, prior to testing, that all staff have the required education and experience and have received the appropriate training for the testing being performed. The staff must be able to demonstrate that they can perform the testing and reliably report accurate results.
• Ensure that policies and procedures have been established for monitoring staff who perform pre-analytic, analytic, and post-analytic steps to assure that they are competent to process, test, and report results of test procedures. When necessary, identify needs for additional training and/or continuing education in order to improve skills.
• Ensure that 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 prior to reporting results.

Source: 42 CFR 493 (Subpart M, 493.1407)

Before your laboratory can perform any testing, your practice must obtain the appropriate CMS CLIA certification. 

CLIA, which is administered by CMS, FDA, and CDC, 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:

1. Certificate of Waiver (COW): Simple tests or examinations with low risk for erroneous results known as waived tests. Tests must be performed according to manufactures instructions without variation to meet the CLIA certificate of waiver criteria.
2. Certificate for Provider Performed Microscopy Procedures (PPMP): Is a subset of moderate complexity tests preformed by physician or midlevel practitioner. PPMP test consist of specific microscopy examinations performed during a patients visit.
3. Certificate of Compliance (COC) or Accreditation (COA): laboratories performing moderate and/or high complexity tests can choose either COC or COA based on the agency who will survey laboratory for compliance to CLIA regulations.

a. COC is issued to a lab after an inspection by state agency and found to be in compliance.

b. COA is issued to a lab after an inspection by a CMS approved non-profit accreditation organization, such as COLA, and found to be complying with CLIA regulations.

For questions about applying for a CLIA certificate or filling out the application:

• Visit the CMS website
• Download the CMS CLIA certification quick start guide