Personnel Regulations

Practice Test (No Cost) | CME Credit Test (Registration for Credit = $425.00)

Marian Schwabbauer, Ph.D., CLDir(NCA)*

*Marian Schwabbauer reports no financial relationships with proprietary entities that produce health care products and services.

Learning Objectives
After completion of this section, the learner will be able to:
  1. define the following credentialing terms described in this section:
    a) Accreditation
    b) Certification
    c) Competence
    d) Competency Testing
    e) Continuing Education
    f) Licensure
    g) Registration
  2. differentiate between the CLIA '88 certificate granted to laboratories and personnel certification.

     

  3. list the four personnel categories required for a moderate complexity laboratory to meet CLIA accreditation requirements.

     

  4. describe the qualification standards for each of the four personnel categories above.

     

  5. specify the responsibilities listed in the CLIA regulations for each of the four personnel categories above.

Introduction
Physician office laboratories (POLs) perform more than half of all laboratory tests. Poor laboratory results can place patients in jeopardy. Physician office laboratory personnel are the critical ingredient in achieving accurate, reliable laboratory data. CLIA '88 established minimum qualifications for personnel based upon the complexity level of the testing being performed. In the process, new, descriptive personnel categories or classifications using completely revised nomenclature were defined that differ significantly from other commonly used personnel certifications or classifications. CLIA '88 (compared to previous HCFA and CLIA regulations) moves the determination of physician office laboratory competency from process review toward outcome measures. For example, less stringent testing personnel standards are balanced by more emphasis on proficiency testing; this is consistent with what is occurring in other areas in society as well, i.e., value added education.

Credentialing Terms
Accreditation refers to the process by which an agency evaluates and recognizes an institution or program of study as meeting certain predetermined standards. For example, the Joint Commission on Accreditation of Health Organizations (JCAHO) accredits hospitals including on site laboratories; the College of American Pathologists (CAP) accredits clinical laboratories; and the National Accrediting Committee for Clinical Laboratory for Clinical Laboratory Sciences (NACCLS) accredits educational programs that prepare clinical laboratory personnel.

Certification is the process by which a non governmental agency grants recognition to an individual who has met certain predetermined education qualifications and technical competencies; certification is voluntary. Certified laboratory personnel are entitled to use letters such as MLT, MT(ASCP); CLT, CLS (NCA), MT(AMT), depending upon the certification obtained, after their name.

Unfortunately the CLIA license is also called a certificate. However, CLIA only licenses or certifies the laboratory not the personnel who staff the laboratory, e.g., personnel who leave a CLIA licensed or certified laboratory to work in another laboratory are not CLIA certified nor is the second laboratory certified. The second laboratory must obtain its own license (certificate).

Competence denotes possession of the required abilities and qualities to perform a job or function; it generally requires both knowledge and skills.

Competency Testing refers to the measurement of individual's ability to perform a certain job; it is often accomplished by observing an individual perform a designated task. A checklist may be used to document performance. Other forms of competency testing may include examinations such as the HEW examination or performance on known samples (proficiency testing).

Continuing education (CE) refers to participation in any educational experience not normally leading to an academic degree, such as attending professional society meetings, taking classes, or completing self-study units.

Licensure is the process by which a governmental agency grants permission to persons meeting pre-determined qualifications to engage in a given occupation, or grants permission to institutions to perform certain functions; it is mandatory when it exists. States that currently license clinical laboratory personnel include California, Tennessee, and Florida. A number of other states have pending licensure legislation at varying stages of progress. You can determine whether or not licensure of clinical laboratory personnel is required in your state by contacting your state public health department.

Registration is the process by which a non governmental agency or association identifies an individual by maintaining (listing) his her name on a roster upon request of the individual; for example, the Board of Registry of the American Society for Clinical Pathology (ASCP) maintains a list or registry of all the individuals who have been certified by their organization. You can easily check a prospective employeeís credentials by calling the agency providing the credential.

Table 1. Summary of credentialing terms used in this course

Accreditation:

Process by which an agency evaluates and recognizes an institution or program of study as meeting certain predetermined standards
Examples: CLIA, JCAHO, CAP, NACCLS, COLA

Certification

Process by which a non governmental agency grants recognition to an individual who has met certain predetermined education qualifications and technical competencies; voluntary
Examples: MLT, MT(ASCP); CLT, CLS (NCA), MT(AMT)

Competence:

Possession of the required abilities and qualities to perform a job or function; generally requires both knowledge and skills

Competency Testing:

Measurement of individual's ability to perform a certain job
Examples: HEW exam, proficiency tests, observation of performance of job duties.

Continuing Education:

Participation in any educational experience not normally leading to an academic degree
Examples: Meetings, classes, self-instructional units

Licensure:

Process by which a governmental agency grants permission to persons meeting pre-determined qualifications to engage in a given occupation, or grants permission to institutions to perform certain functions; mandatory
Examples: California, Tennessee, Florida

Registration:

Process by which a non governmental agency or association identifies an individual by maintaining (listing) his her name on a roster upon request of the individual
Examples: ASCP

CLIA Personnel Requirements and Classifications
CLIA '88 establishes site neutral laboratory personnel requirements. The regulations apply to all clinical laboratories, not just physician office laboratories. Those clinical laboratories certified to perform only waived tests have no personnel requirements imposed by CLIA '88. However, only a few tests have been classified as waived. Laboratory supply companies are attempting to design instruments and procedures so that they meet the criteria for classification as waived tests.

The remainder of this section will discuss the personnel requirements for moderate complexity laboratories. Laboratories who wish to perform any tests classified as moderate complexity must have the following four categories of personnel: laboratory director, technical consultant, clinical consultant, and testing personnel. All four categories can be covered by the same individual if s/he meets the qualifications for each category. For example, the laboratory director can qualify as the technical consultant only if he or she has the required hands on laboratory testing experience.

Laboratories certified to perform tests of high complexity must have an individual classified as a technical supervisor rather than the technical consultant, and a general supervisor in addition to the laboratory director, clinical consultant, and testing personnel required in the moderate complexity laboratory. The qualifications and responsibilities specified for testing personnel in the high complexity laboratory vary somewhat from those listed for testing personnel in the moderate complexity laboratory. Again one individual may meet the criteria for and fulfill the requirement for more than one category of personnel. If a laboratory engages in cytology testing it must also have the following two categories of personnel: Cytology general supervisor and Cytotechnologist, who again may be the same person. b>Qualification Standards
CLIA personnel standards are designed to assure that laboratory personnel have the appropriate training and experience to adequately perform the level of tests that the laboratory offers. Only the qualifications for those personnel categories required for the moderate complexity laboratory will be described; similar information about personnel requirements for the high complexity laboratory is available.

Laboratories certified to perform moderate complexity tests must have personnel who meet the following specified qualifications.

Laboratory Director
There are five routes that will qualify an individual to fill the Laboratory Director requirement.

1. Pathologist or

2. Licenced MD, DO or Doctor of Podiatry with:

One year of experience directing/supervising non-waived tests; or

Effective September 2, 1993, have at least 20 CME credit hours in laboratory practice commensurate with director duties; or laboratory training during residency equivalent to 20 CME rule above, or certification in hematology or hematology/oncology

3. Doctorate in science with:

1 year of full-time experience supervising non- waived testing; or

clinical laboratory-related board certification

4. Master in science with:

1 year supervisory experience

1 year laboratory training or experience; and

5. Baccalaureate in science with :

2 years of laboratory training or experience; and 2 years of supervisory experience

The twenty hours of CME credit must cover preanalytic, analytic, and postanalytic phases of testing.It should provide information about the principles and theories of laboratory practice including: quality control and quality assurance; proficiency testing; patient test management and development; and implementation of personnel policy and procedures. It should include hands-on laboratory testing experience. Courses related to laboratory payment and CPT coding would not fulfill this requirement.

There are also two routes by which one can be "grandfathered" in as a laboratory director: if on February 28, 1992, they were previously qualified as a laboratory director under March 14, 1990 Medicare/CLIA '67 rules or were qualified under state law to direct a laboratory in that state.

Clinical Consultant
A Clinical Consultant must be qualified as a laboratory director under #1, #2, or #3 above; or be a licensed MD/DO.

Technical Consultant
The Technical Consultant must meet one of the following four qualifications:

Testing Personnel
All Testing Personnelmust meet one of the following two qualifications:

The laboratory director is responsible for assuring and documenting that each person, regardless of education or experience, who performs a laboratory test is competent to perform that laboratory test. Responsibilities of Each Category of Laboratory Personnel Under CLIA '88 the responsibilities of each category of laboratory are clearly spelled out.

Laboratory Director
The director is responsible for the overall operation and administration of the laboratory, including hiring personnel who can perform test procedures and to record and report test results promptly, accurately, and proficiently. He or she is also responsibile for compliance with CLIA regulations. The laboratory director must be accessible but not necessarily on-site during testing. Each individual director can direct no more than five laboratories. Specifically, the laboratory director must ensure that:

A.the testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of the test performance.

B.the physical plant and the environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected.

C.the testing methods selected have the capability of providing the quality of results required for patient care; the verification procedures used are adequate to determine accuracy, precision and other pertinent performance characteristics of the method; and that laboratory personnel are performing the test methods as required for accurate and reliable results.

D.the laboratory is enrolled in a approved proficiency testing (PT) program and that all requirements for participation in PT are met.

E.quality control (QC) and quality assurance (QA) programs are established and maintained.

F.acceptable levels of analytical performance are established and maintained for each test system.

G.all remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified.

H.reports of test results include pertinent information required for interpretation.

I.consultation is available to the laboratory's clients on matters relating to the quality of testing.

J.a sufficient number of laboratory personnel who are appropriately qualified to provide consultation and supervision, perform tests, and report test results accurately are employed.

K.all personnel have the required education and training or experience to perform their assigned functions.

L.policies and procedures are established to monitor individuals who conduct the pre-analytical and post-analytical phases of testing, and whenever necessary identify the need for remedial training or continuing education.

M.an approved procedure manual is available to all personnel.

N.the responsibilities and duties of each consultant and each person engaged in the testing process are specified in writing. Identification of which procedures and examinations each individual is authorized to perform; whether supervision is necessary; and whether the consultant or director should review patient results before they are reported must be included.

Clinical Consultant
Generally, 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. Specifically, the clinical consultant must:

 
A.be available to provide clinical consultation to the laboratory's clients;

B.be available to assist the laboratory's clients in ensuring that appropriate test are ordered to meet the clinical expectations;

C.ensure that reports of test results include all pertinent information required for patient-specific interpretation of results; and

D.ensure that consultation is available to the laboratory's clients on matters related to the quality and interpretation of test results.

Technical Consultant
The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant does not have to be on-site but must be accessible to the laboratory to provide on-site and telephone consultation as needed. Specifically, the technical consultant is responsible for:

A.selecting test methods.

B.verifying the test procedures and the establishment of the laboratory's test performance characteristics, when necessary.

C.enrolling and participating in an approved proficiency testing (PT) program.

D.establishing a quality control (QC) and quality assurance (QA) program.

E.resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

F.ensuring that patient test results are not reported until corrective actions are taken and the test system is functioning properly.

G.identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the laboratory and the testing being performed.

H.evaluating the competency of all testing personnel and assuring that all staff maintain their competency to perform the test procedures and report patient test results promptly, accurately and proficiently. The procedures for evaluation of competency must include, but are not limited to:
Direct observation of routine patient test performance;
Monitoring the recording and reporting of test results;
Review of intermediate test results and worksheets, quality control (QC) records,
Proficiency testing (PT) results and preventive maintenance and function checks;
Direct observation of performance of instrument maintenance and function checks;
Assessment of test performance through testing previously analyzed specimens,
Internal blind testing samples or external proficiency testing (PT) samples; and
Assessment of problem solving skills.
I.evaluating and documenting the performance of individuals responsible for moderate-complexity testing at least semi-annually during their first year. Thereafter, evaluations must be performed at least annually unless the methodology or instrumentation changes, in which case before reporting any patient results, the individual's performance must be re-evaluated to include the new methodology or instrumentation.

Testing Personnel
Generally, testing personnel perform the actual testing process. Specifically, testing personnel must:

A.follow the laboratory's procedures for handling specimens. processing tests, analyzing tests, and reporting and maintaining records of patient results.

B.maintain records that demonstrate that proficiency testing (PT) samples are tested in the same manner as patient samples.

C.adhere to the laboratory's quality control (QC) policies, documenting all QC activities, instrument and procedural calibrations, and maintenance performed. Note: the director must review these records to make sure that each instrument is functioning properly.

D.follow the laboratory's established corrective action policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance.

E.be capable of identifying problems that may adversely affect test results and either correct the problems or immediately notify the technical consultant, clinical consultant or director. Testing personnel must be instructed to notify the appropriate person immediately if there is a technical problem affecting the test results.

F.document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.

This completes the first module on CLIA personnel regulations. The second module, CLIA Personnel Regulations II, will cover sources of personnel and continuing education. It will also address competency testing and other personnel related issues in the moderate complexity laboratory.

Personnel Regulations
Practice Test (No Cost) | CME Credit Test (Registration for Credit = $425.00)

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