Laboratory Personnel Evaluation Roster

The Personnel Evaluation Roster (PER) is used to ensure that laboratories are staffed with appropriately qualified personnel with documentation of their education and laboratory experience. The laboratory must confirm that personnel files contain the necessary information to be in compliance with the CLIA personnel qualification regulations and CAP Checklist requirements, as stated in checklist item GEN.54400, prior to the inspection. On the day of inspection, the roster is reviewed by the inspection team to help in auditing personnel records.

The PER and associated personnel records must be audited annually by the director or designee for nonwaived testing personnel and personnel fulfilling supervisory roles (GEN.54025).

This audit must include a review of ALL files of personnel hired within the last 12 months, a mixture of laboratory and non-laboratory personnel (POC, PPM, Radiology, etc.), full and part-time on all shifts and personnel fulfilling supervisory roles (laboratory director, technical supervisor, staff pathologist, etc.).

The roster must be completed for all laboratories enrolled in the LAP, FDT, and RLAP programs, including international laboratories. Laboratories enrolled in the Biorepository Program are required to submit the Biorepository Laboratory Personnel Evaluation Roster in paper format.

The laboratory must complete the PER electronically through the cap website, www.cap.org - eLab Solutions Suite. The PER is located under Organization Profile, Roles/Personnel. Instructions for completing the roster are in each section.

Laboratories have two options when listing personnel currently fulfilling CLIA defined roles and/or duties based on the test complexity performed by the laboratory (see question #13). The CLIA-defined roles include the Laboratory Director, Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, Cytology General Supervisor, Cytotechnologist, Staff Pathologists, laboratory and non-laboratory testing personnel performing nonwaived testing. If the laboratory director is qualified to fulfill one or more of the CLIA- defined roles, the laboratory must document all applicable roles he/she is fulfilling on the PER. The laboratory director must sign the PER attesting that all information for each person listed on the PER is accurate and complete.

The Personnel Evaluation Roster must be completed/updated during the application/reapplication process. The laboratory must complete the PER task online in the Organization Profile section by the due date of the application/reapplication. It is the laboratory’s responsibility to keep the roster up to date after submission.

The laboratory director (identified on the CAP/CLIA certificate) must electronically sign and date the roster attesting that the individuals listed meet the personnel qualifications required for the testing/roles they fulfill. For laboratories not subject to US regulations, the director must be a MD, DO, PhD or have commensurate education and experience necessary to meet personnel requirements as determined by the CAP.

Phlebotomists and specimen processors need to be listed only if they also perform non-waived testing (e.g., perform bleeding times). If these individuals do not perform any non-waived patient testing but are involved in reagent preparation, specimen preparation, or microbiology plating, it is not necessary to list those individuals on the Personnel Evaluation Roster. Individuals who perform only waived testing do not need to be listed on the roster. Non-laboratory personnel (e.g., nurses, respiratory therapists) who perform non-waived testing must be listed on the roster in the Testing Personnel – Non-Laboratory section.

If the supervisor and/or administrators are fulfilling any CLIA defined role or duties (e.g., Technical Consultant, General Supervisor, testing personnel), they must be listed on the roster and meet the appropriate education and experience requirements.

If PPM providers are performing non-waived testing under the CLIA license of a laboratory, they must be included on the Personnel Roster. Physicians and Midlevel providers (nurse midwife, nurse practitioners or physician assistants) must be licensed in the state in which the laboratory is located. If physicians and midlevel providers performing testing have a separate PPM certificate and are not under the oversight of the laboratory, they do not need to be listed on the Personnel Roster.

Staff pathologists must also be listed as testing personnel on the roster as well as any other roles they are fulfilling, such as Technical Supervisor.

If the histologist is performing any part of the macroscopic tissue examination (e.g. grossing) or verifying acceptable performance of special stains including histochemical stains and studies using immunologic and ISH methodology (ANP.21395), which is considered high complexity testing, it is necessary to list those personnel on the roster as testing personnel. Grossing is defined as a tissue examination requiring judgment and knowledge of anatomy. This includes the dissection of the specimen, selection of tissue, and any level of examination/description of the tissue including color, weight, measurement or other characteristics of the tissue. The laboratory must have records of education and training meeting the CLIA requirements for high complexity testing personnel. The minimum training/experience required of such personnel is: 1) an earned associate degree in a chemical or biological science or medical laboratory technology, obtained from an accredited institution, OR, 2) Education/training equivalent to the above that includes the following: 60 semester hours or equivalent from an accredited institution. This education must include 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that includes six semester hours of chemistry, six semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination, AND laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLS, or other organization approved by The Center for Laboratory Medicine Services (note that this training may be included in the 60 semester hours listed above), OR at least three months of recorded laboratory training in each specialty in which the individual performs high complexity testing. It is the responsibility of the laboratory director to determine whether an individual’s education, training and experience satisfy the requirements.

The laboratory must list the cytotechnologists on the PER with an annotation of the appropriate qualifications (from the items below) for each cytotechnologist. Certification in cytotechnology by a certification agency approved by The Center for Laboratory Medicine Services (e.g., ASCP) is acceptable documentation of educational qualification. This is the only area where a certification is acceptable.

All non-supervisory cytotechnologists meet at least one of the following qualifications.

1. Graduated from an Accrediting Bureau of Health Education Schools (ABHES) accredited school of cytotechnology or other organization approved by The Center for Laboratory Medicine Services; or
2. Certified in cytotechnology by a certification agency approved by The Center for Laboratory Medicine Services (e.g. American Society of Clinical Pathology); or
3. Before September 1, 1992, have successfully completed two years in an accredited institution (12 semester hours in science, eight of which are in biology) and have 12 months training in an approved school of cytotechnology; or have received six months formal training in an approved school and six months full-time experience; or
4. Before September 1, 1992, have achieved a satisfactory grade in The Center for Laboratory Medicine Services proficiency test for cytotechnologists
5. Before September 1, 1994, have two years full-time experience or equivalent within the preceding five years examining slides under the supervision of a physician certified in pathology and before January 1, 1969, be a high school graduate with six months cytotechnology training in a laboratory directed by a physician and completed two years fulltime supervised experience in cytotechnology before 1/1/69; or
6. On or before September 1, 1994, have two years full-time experience or equivalent within preceding five years in the US and on or before September 1, 1995, have either graduated from a CAHEA-approved school or be certified as a cytotechnologist.

Yes, the Laboratory Director must be identified. Mark the form as ”waived testing only” for the remaining positions.

Yes, if these individuals are performing non-waived testing they must be listed on the roster. Medical technologist trainees who work entirely under the supervision of another individual and are not the testing person of record do not need to be listed on the PER. Residents or fellows performing unsupervised tissue grossing are considered the testing person of record and therefore, would need to be listed as testing personnel on the roster. The laboratory must ensure that these individuals have the appropriate education and experience, received the appropriate training for the type and complexity of the services offered and have demonstrated that they can reliably perform all assigned duties.

The laboratory MUST list at least ONE individual who is fulfilling each of the CLIA-defined roles on the PER. Additionally, the laboratory has two options:

• Option A – The laboratory must have a fully defined delegation process which includes a mechanism, in writing, to identify individuals fulfilling the CLIA-defined roles or a portion of a role (such as performing competency assessment). Examples of the mechanism could include spreadsheets, delegation policy with grid, templates, etc. The mechanism must be detailed enough to demonstrate that all duties within he CLIA-defined roles are fulfilled by qualified individuals.
  OR
• Option B – The laboratory must list ALL other qualified individuals who are fulfilling the CLIA-defined roles or a portion of a role (such as performing competency assessment) on the PER and have appropriate delegation in writing.

The laboratory must list all personnel fulfilling CLIA defined roles and/or duties which correspond to the complexity of testing being performed. For laboratories performing moderate and high complexity testing, this includes: Laboratory Director, Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel. For moderate complexity testing only, it includes the Laboratory Director, Clinical Consultant, Technical Consultant, and Testing Personnel. The Laboratory Director, if qualified, may fulfill more than one role. If an individual fulfills more than one role, the laboratory must list this person in each role.

A copy of the diploma or transcript is acceptable.

The academic degree (associate, bachelor’s, master’s or doctorate) must show that the person has satisfactorily completed the prescribed studies in a biological, chemical or physical science, or clinical laboratory science or medical laboratory technology from an accredited institution. The type of degree required is based on the complexity level of testing performed. The Laboratory Director is responsible for ensuring that testing personnel have the appropriate education and training for the type and complexity of testing performed.

Personnel performing moderate complexity testing, both laboratory and non-laboratory (e.g. nurses, respiratory therapists, radiologic technologists and medical assistants), must, at a MINIMUM, have earned a high school diploma or equivalent AND have records of training appropriate for the testing performed prior to analyzing patient specimens. Such training must include: 1) specimen collection, including patient preparation, labeling, handling, preservation, processing, transportation, and storage of specimens, as applicable; 2) implementation of all laboratory procedures; 3) performance of each test method and for proper instrument use; 4) preventive maintenance, troubleshooting and calibration procedures for each test performed; 5) working knowledge of reagent stability and storage; 6) implementation of quality control policies and procedures; 7) an awareness of interferences and other factors that influence test results; and 10) assessment and verification of the validity of patient test results, including the performance of quality control prior to reporting patient results. A doctorate, master’s, bachelor’s or associate degree in a biological, chemical or physical science or clinical laboratory science or medical laboratory technology from an accredited institution is also acceptable.

Personnel performing high complexity testing must, at a MINIMUM, have earned an associate degree in a biological, chemical, physical or clinical laboratory science or medical technology from an accredited institution, or equivalent laboratory training and experience. The equivalent laboratory training and experience include 60 semester hours or equivalent from an accredited institution that, at a minimum, includes either 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that include six semester hours of chemistry, six semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination; AND laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLS, or other organization approved by The Center for Laboratory Medicine Services (note that this training may be included in the 60 semester hours listed above), OR at least three months documented laboratory training in each specialty in which the individual performs high complexity testing. A doctorate, master’s or bachelor’s degree in a biological, chemical, physical or clinical laboratory science or medical laboratory technology from an accredited institution is acceptable.

A bachelor’s or associate degree in nursing or respiratory therapy or pulmonary science meets the requirement for earning a degree in a biological science for respectively, high complexity and moderate complexity testing personnel (see exceptions for laboratories in California GEN.78250). The diploma MUST include the field of study, e.g., Bachelor of Science in Biology, Bachelor of Science in Medical Technology. A diploma that is not in a science-related field or simply states Bachelor of Science degree does not meet the requirements. If the diploma does not include the field of study, a transcript must be obtained as documentation of the science field.

If employees do not have a copy of their diploma or transcript, they must obtain the documents from the school. While the procedure will vary among educational institutions, in general, an individual should contact the school directly to obtain instructions for ordering a transcript or copy of the diploma.

This applies even if the degree program no longer exists at the institution, but the institution itself is still in existence. If the university/college is no longer in existence, contact the Department of Education in the state where the university/college was located for instructions. For high school diplomas, contact the school directly. If the school is closed, contact the school board for the school district where the high school was located or the State Board of Education for further guidance. If no records are available, the laboratory must document the attempts to obtain diplomas/transcripts and maintain records that the school has closed, and no records are available. It is the laboratory director’s responsibility to ensure that personnel are qualified. The laboratory director must assess the training and experience of the individual to meet the needs of the laboratory. This assessment must be documented, signed by the laboratory director, and be available in the personnel records.

Primary source verification is the process of confirming an applicant’s credentials by verifying that a degree, certificate or diploma was received, that licenses were granted, and by confirming reported work history, such as company names and locations, dates, and positions held. Verifications are obtained DIRECTLY from an institution, former employers, or their authorized agents.

The laboratory, not the PSV company is responsible for determining whether a given individual meets the personnel qualifications. It is the laboratory’s responsibility to determine if the information provided in the PSV report is sufficient to determine if the person is qualified for the position held.

If PSV is used, the laboratory must have a defined system for reviewing PSV reports, with written criteria for accepting records. If there are required elements for the qualifications that the PSV report does not adequately verify (e.g., transcripts, educational equivalency for personnel trained outside of the US, or reports lacking the type of degree earned), there must be records showing the qualifications are met using other means. The laboratory must maintain either paper or electronic records.

Ultimately, it is the Laboratory Director’s responsibility to ensure that personnel qualifications are met for each position and there is documented evidence of the qualifications.

Credentials for supervisory and testing personnel educated outside the US must be evaluated to

ensure that their education is equivalent to an education obtained in the United States (US) and meet the CLIA requirements. Evaluation of such equivalency must be performed by a nationally recognized organization. Examples of such organizations include the National Association Credential Evaluation Services, Inc (NACES) and The Association of International Credential Evaluators, Inc, (AICE), or other organizations approved by The Center for Laboratory Medicine Services. The equivalency evaluations should be on a course-by-course basis. Once the evaluation has been completed and is deemed acceptable, a copy of the evaluation must be retained in the personnel file.

Physicians (MD., D.O., DDS) educated outside of the US who are licensed to practice in the state in which the laboratory is located do not need to produce educational equivalencies. A valid state medical license is sufficient proof of academic achievement.

Individuals educated outside of the US with a PhD must provide documentation of certification from The Center for Laboratory Medicine Services approved board to demonstrate academic achievement AND provide foreign education equivalencies. Currently, The Center for Laboratory Medicine Services approved boards are:

ABB- American Board of Bioanalysis

ABB Public Health Microbiology certification

ABCC – American Board of Clinical Chemistry

ABFT- American Board of Forensic Toxicology

ABHI – American Board of Histocompatability and Immunogenetics

ABMGG – American Board of Medical Genetics and Genomics

ABMLI – American Board of Medical Laboratory Immunology

ABMM – American Board of Medical Microbiology

NRCC – National Registry for Certified Chemists

For supervisory and laboratory testing personnel educated outside of the US, a state laboratory personnel license may be used to demonstrate educational equivalency ONLY in states that require laboratory personnel licensure. State licensure for other types of personnel, such as nursing, respiratory therapy, or radiology, is NOT acceptable documentation of equivalency.

The laboratory director can designate an individual who is familiar with the educational requirements for all technical positions. This person must be able to assess whether each individual qualifies to function in the position indicated on the form.

The records for the verification of the educational qualifications using the credentialing system can be used instead of maintaining a separate copy of a diploma or transcript. This applies to all laboratory and non-laboratory testing personnel (e.g. POCT and blood gas personnel). These laboratories are not under the authority of the Centers for Medicare and Medicaid Services and the use of their standardized credentialing system has been accepted by the CAP. On the day of inspection, the laboratory must be able to provide records of employee qualifications for all testing personnel to the inspector upon request.

Laboratory testing personnel who earned high school diplomas and were trained to perform high complexity testing prior to September 1, 1997 are allowed to continue performing high complexity testing in the specialty area that they were performing testing in prior to 9/1/97 . For example, if an individual was trained and deemed qualified to perform high complexity testing in a specialty such as Blood Bank prior to 1997 and currently performs testing in that specialty, they are still qualified to perform testing IN THAT SPECIALTY. The individual may also perform new testing in that specialty, e.g., gel testing, automated methods. However, if the individual moves to a different area of the laboratory where high complexity testing is performed, such as Molecular Diagnostics, the individual must now meet the current CLIA requirements for personnel performing high complexity testing with education and training equivalent to an associate degree. Besides having records of the high school diploma or equivalent, the laboratory must retain documentation of the training appropriate to the testing performed. Documentation may include letters from training programs or employers or an attestation statement by the laboratory director. The laboratory director is responsible for ensuring that testing personnel have the appropriate education and experience and receive the appropriate training for the type and complexity of testing performed.

A copy of the employee’s diploma/transcript or primary source verification is required as proof of academic achievement for all non-laboratory personnel performing non-waived POCT. Per CMS, copies of state licensure for non-laboratory personnel (nurses, respiratory therapists, etc.) are not acceptable documentation of academic achievement. The diploma must include the area of study, (e.g., Nursing, Respiratory Therapy, Biology, etc.). A diploma that is not in a science-related field or simply states Bachelor of Science degree does not meet the requirements. In this case, the laboratory must obtain a transcript to ensure that the individual has completed the required number of specific science credit hours. The laboratory director is responsible for ensuring that all non-laboratory personnel fulfill the necessary qualifications for laboratory testing.

POCT personnel files may be kept in the corresponding department where they are employed (e.g., Nursing Education, Radiology, Respiratory Therapy). The files must be readily available to the inspection team on the day of the inspection but need not be kept in the laboratory.

If the state that the laboratory is located in requires licensure of laboratory personnel, then a copy of

the state license alone is acceptable. The state requirements must be at least equivalent to CLIA. As of this date, current states requiring state licensure for clinical laboratory personnel include: California, Florida, Hawaii, Montana, Nevada, New York, North Dakota, Louisiana, Tennessee and West Virginia. The territory of Puerto Rico also requires licensure. Questions regarding state licensure should be directed to the individual state Department of Health or laboratory licensing. Specific requirements regarding personnel qualifications and licensure from the state of California may be found in the Laboratory General checklist GEN.78200-GEN.78425.

Licensure for nurses or respiratory therapists is not acceptable documentation of educational experience; a copy of the diploma, transcript or primary source verification report is required.

The CAP does not accept certifications. The certificate alone is not considered adequate documentation that educational qualifications have been met. A copy of the ASCP certification is only necessary if certification is required by your laboratory.

The number of personnel records to be examined is based upon a percentage of the total number of technical FTEs listed on the Personnel Evaluation Roster. The review includes a mixture of part-time and full-time, testing and supervisory personnel from all shifts and areas (POCT, Respiratory Therapy, etc.). Records for ALL new laboratory personnel hired within the last two years and non-laboratory personnel who started performing testing with the last two years will be reviewed. In addition to documentation of educational qualifications, the personnel records must contain all items required by GEN.54400. The records/items must be available at the time of the inspection, but need not all be in the personnel file.

The laboratory director must be able to provide, evidence of current medical licensure in the jurisdiction where the laboratory is located and/or current board certification, training or experience as applicable. For the inspection, the CAP provides the inspection team leader with the director’s curriculum vitae. While on-site, the inspector confirms that the credentials of the laboratory director and licensure and certification are current.

For directors of moderate complexity laboratories using the 20 hours of continuing medical education credit hours in laboratory medicine as a qualification (DRA.10100), these hours may be obtained through the University of Iowa online computer assisted laboratory director course or the COLA Lab University online laboratory director course. Evidence of completion of the course must be available to show compliance.

Records must show that military staff have successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). Enlisted military personnel, when successfully completed training, will be granted special codes for this specialized training, e.g., NEC (Navy Enlisted Code: Medical Laboratory Technician), MOS (Military Occupational Specialty: Medical Laboratory Technician) or AFSC (Air Force Specialty Code). Successful completion of the 50-week course qualifies personnel to perform moderate and high complexity testing.

The Centralized Credential System (CCQAS) may be used to access the educational records for licensed physicians, nurse practitioners or pharmacists. Medical technicians, nurses and respiratory therapists are required to submit a copy of their transcript and the appropriate enlisted code certificate.

The laboratory may retain personnel records in separate locations. The laboratory must be able to produce all necessary documentation during the inspection, in a timely manner.

A technologist with HEW certification qualifies to perform high complexity testing. Individuals who received an acceptable score on the exam were issued an HEW card and were then qualified to perform high-complexity testing. Individuals who are HEW certified also qualify as a General Supervisor.

No, a Board of Regents Bachelor of Arts does not meet the requirement. The Board of Regents Bachelor of Arts is a baccalaureate degree program for adult students to earn college-equivalent credit for work and life experiences that can be equated to college courses. It is designed to provide students with a comprehensive general education. There is no designation of a major. CLIA regulations require that a bachelor’s degree be obtained from an accredited institution. The degree must be in a chemical, physical, biological or clinical laboratory science or medical technology.

Home schooling is considered a form of “private education”. Parents who choose to educate their children at home are under a legal obligation to ensure attendance and teach branches of education taught to children of corresponding age and grade in public schools. The home school students may not participate in public school graduation ceremonies; however, they are entitled to receive a high school diploma if they have met the graduation requirements. This diploma would serve as documentation of meeting the educational requirements at the high school level.

Testing personnel performing high complexity testing must be assessed by the section director, or individual meeting the qualifications of a technical supervisor if delegated in writing. The technical supervisor may delegate the responsibility in writing to a general supervisor.

Testing personnel performing moderate complexity testing must be assessed by an individual meeting the qualifications of a technical consultant. The minimum qualifications for a Technical Consultant are a bachelor’s degree in a chemical, physical or biological science or medical technology AND at least 2 years of experience in nonwaived testing in the designated specialty or subspecialty.

An individual with a bachelor’s degree in Nursing or Respiratory Therapy with the two years of experience in the specialty being assessed, does qualify as a Technical Consultant, EXCEPT in the state of California. In the state of California, nurses and respiratory therapists can perform moderate complexity testing, however, they CANNOT perform competency assessments of individuals performing moderate complexity tests.

In states where laboratory personnel are required to be licensed, the laboratory must ensure that the Technical Consultant meets the educational qualifications of the Technical Consultant. A copy of the diploma or transcript is required as some states grant licensure to personnel with qualifications other than a bachelor’s degree.

If the bachelor’s degree is in a field that is science-related but not specific for biology or chemistry, the laboratory should review the individual’s transcript for successful completion of courses in human biology and chemistry courses. There are no specific required number of credit hours in each science. The laboratory director must approve the qualifications of individuals delegated as Technical Consultants.

Initial training can be performed by personnel who are competent in all phases of the testing process. The CAP does not have educational requirements for individuals performing training. The laboratory may use the assistance of manufacturer’s technical support staff when installing a new instrument, however, laboratory staff must be involved in the training process for details that specifically apply to the laboratory.

Test complexity is determined by the FDA. Visit the FDA website.

Yes, a resume may be used as documentation of previous work experience and training. The initial training and semi-annual/annual competency assessments that have been performed at the current institution will be reviewed by the inspection team as documentation of completed training and experience. The laboratory should indicate whether supervision is required for all testing. The format of that information is at the discretion of the laboratory.

No, CMS requires competency of nonwaived testing to be assessed at the laboratory (CAP/CLIA number) where the testing is performed as there may be variations on how testing is performed at different sites. The competency assessment records may be retained centrally within a healthcare system but must be available upon request.

For waived testing, the laboratory director may determine how competency will be assessed for personnel performing testing at multiple test sites (same CAP/CLIA number) or laboratories within the healthcare system (different CAP/CLIA number). If there are variations on how a test is performed at different test sites or laboratories, those variations must be included in the competency assessment specific to the site or laboratory.

The supervisory performance assessment should be an evaluation of the assigned supervisory duties such as monthly QC review, consultations, resolution of problems, orientation, and training of personnel. The laboratory may develop a form with specific details of the job, expectations, and grading criteria. The duties must be assigned in writing by the Laboratory Director. The frequency of performance review should be determined by the Laboratory Director.

If supervisory personnel are ALSO performing patient testing, they MUST also be assessed for competency for the applicable test systems.

For personnel licensed in the State of Florida, please list each number for the specialty they are licensed to perform. The specialties are as follows:

1. Microbiology
2. Serology/Immunology
3. Clinical Chemistry
4. Hematology
5. Immunohematology/Blood Banking (Donor Processing)
6. Cytogenetics
7. Molecular Pathology
8. Histocompatibility
9. Histology
10. Cytology
11. Andrology
12. Embryology
13. Oral Pathology
14. Respiratory Therapy

Additional resources that you may wish to refer to include the following:

• CAP Personnel Requirements by Test Complexity
• Laboratory General Checklist
• Director Assessment Checklist
• CMS Brochures on competency assessment and laboratory director responsibilities
• Laboratories with California Clinical Laboratory Licensure Frequently Asked Questions