Laboratory Personnel Evaluation Form
What is the purpose of the Laboratory Personnel Evaluation Roster Form (PER)?
The Laboratory Personnel Evaluation Roster (PER) form is used to ensure that laboratories are staffed with appropriately qualified personnel and they have adequate documentation of these personnel qualifications. 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 form is used by the inspection team to assist in the auditing of personnel records.
Effective July 2016: The PER form and associated personnel records must be audited annually by the director or designee. This audit must include a review of ALL personnel hired within the last 12 months, a mixture of laboratory and non-laboratory personnel (POC, PPT, Radiology, etc.), full and part-time on all shifts and personnel fulfilling supervisory roles (laboratory director, technical supervisor, staff pathologist, etc.).
Is the Laboratory Personnel Evaluation Roster Form required for laboratories in all CAP accreditation programs?
The form is required of all laboratories enrolled in the LAP, FDT, RLAP programs, including international laboratories. Laboratories enrolled in the Biorepository Program are required to submit the Biorepository Laboratory Personnel Evaluation Roster form.
What is the process for completing the Laboratory Personnel Evaluation Roster form?
Laboratories must list all personnel currently fulfilling CLIA defined roles and/or duties which include the Laboratory Director, Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, Cytology General Supervisor, Cytotechnologist, Staff Pathologists, and Nonwaived Testing Personnel. If the laboratory director is qualified to fulfill one or more of the CLIAdefined roles, the laboratory must document all applicable roles on the PER. Instructions for completing the PER are available on the CAP website and also included in the application packets. An excel version of the PER is available on the CAP website; when using the electronic roster, complete each of the three tabs that appear at the bottom of the page (Director/Supervisory Personnel, Laboratory Personnel and Non-Laboratory Personnel). The laboratory director must sign the PER attesting that all information for each person listed on the PER is accurate and complete.
When do I need to have my Laboratory Personnel Evaluation Roster form completed and returned to the CAP headquarters?
The Laboratory Personnel Evaluation Roster form is included in the application/reapplication materials. The forms must be submitted with the completed application materials by the due date of the application. It is the laboratory's responsibility to keep the roster up-to-date after submission. On the day of the inspection, an updated roster should be presented to the inspection team if any personnel changes were made since the application was submitted.
Whose signature must appear on the Laboratory Personnel Evaluation Roster? Is an electronic signature acceptable??
The laboratory director (identified on the CAP/CLIA certificate) must sign and date the last page of the roster attesting that the individuals listed meet the personnel qualifications required for the testing they perform. 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. Unsigned forms or forms signed by someone other than the laboratory director will not be accepted. An electronic signature is acceptable from laboratories that submit the application/reapplication through eLAB Solutions on the CAP website.
Do we need to list the phlebotomy staff, specimen processing staff, personnel that only perform waived testing and Point-of Care testing personnel on the Laboratory Personnel Evaluation Roster?
Phlebotomists and specimen processors need to be listed only if they also perform non-waived testing (e.g., perform bleeding times). If they do not perform any non-waived patient testing (e.g., individuals who do reagent preparation, specimen preparation, or microbiology plating), it is not necessary to list phlebotomists and specimen processors on the Personnel Evaluation Roster. Personnel that 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.
If my laboratory uses a data management system to track POC testing personnel, can I provide a printout from the DMS in lieu of the Personnel Evaluation Roster form? Can I use a different form to submit the information regarding personnel qualifications?
It is recommended that the laboratory upload the list of names of testing personnel list from the DMS to the CAP PER form and then complete the required columns for each employee as applicable. If the laboratory uses a different form to document personnel rosters, ALL information that is required on the CAP PER must be also included on the form.
Do supervisors and/or administrators that are not performing testing need to be included on the roster?
If the supervisor and/or administrators are fulfilling any CLIA defined role or duties (e.g., Technical Consultant, General Supervisor), they must be listed on the roster and meet the appropriate education and experience requirements.
Are physicians who perform PPM required to be listed on the personnel roster?
If 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.
Do histologists need to be listed on the Laboratory Personnel Evaluation Roster?
If the histologist is performing any part of the macroscopic tissue examination (e.g. grossing), which is considered high complexity testing, it is necessary to list those personnel on the roster. 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, NAACLA, or other organization approved by HHS (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.
Do cytotechnologists need to be listed on the PER and what records are required to demonstrate qualifications of a cytotechnologist?
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 HHS (e.g., ASCP) is acceptable documentation of educational qualification.
All non-supervisory cytotechnologists meet at least one of the following qualifications.
- Graduated from an Accrediting Bureau of Health Education Schools (ABHES) accredited school of cytotechnology or other organization approved by Health and Human Services (HHS); or
- Certified in cytotechnology by a certification agency approved by HHS (e.g. American Society of Clinical Pathology); or
- 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
- Before September 1, 1992, have achieved a satisfactory grade in an HHS proficiency test for cytotechnologists
- 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
- 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.
My laboratory has a certificate of waiver. Do I need to submit a PER?
Yes, the Laboratory Director must be identified. Mark the form as "waived testing only" for the remaining positions.
Do we need to list residents, fellows or medical technology students on the PER?
If these personnel 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 personnel 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.
If we have more than one person who qualifies as a Technical Consultant and they perform competency assessments for moderate complexity testing, do we need to list all such personnel as Technical Consultants on the PER?
Yes—list all persons who are fulfilling the role of the Technical Consultant (such as those performing competency assessments for moderate complexity testing). The laboratory must ensure that the person performing the assessment meets the educational and experience requirements for that CLIA-defined role.
Does every position on the PER need to have a person filling that role?
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 a person does fulfill more than one role, the laboratory must list this person in each role.
Can we accept copies of diplomas or transcripts from our employees or do these documents need to be originals or official transcripts with the seal from the registrar?
A copy of the diploma or transcript is acceptable.
What academic degrees are acceptable as evidence of appropriate educational experience for personnel performing non-waived laboratory testing (moderate or high complexity testing)?
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 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 HHS (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 meets the requirement for earning a degree in a biological science for respectively, high complexity and moderate complexity testing personnel.
How do employees obtain transcripts or diplomas and what if the school has closed?
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 contacts 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.
Our HR department uses primary source verification (PSV) to confirm personnel credentials. What does this involve and what is the laboratory's responsibility?
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.
What records are required for reviewing the qualifications of personnel educated and trained outside of the United States?
Credentials for supervisory and testing personnel educated outside the US must be evaluated to ensure that their education is equivalent to CLIA requirements. Evaluation of such equivalency must be performed by a nationally recognized organization. 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 HHS. 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 an HHS approved board to demonstrate academic achievement and provide foreign education equivalences. Currently, the HHS 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 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.
Who is qualified to evaluate the transcripts, diplomas and primary source verification records to be sure that these documents meet the requirements?
TThe 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.
Can the credentialing systems used by the Department of Veterans Affairs (e.g., VetPro Credentialing System) and the Department of Defense (CCQAS) be used to document educational qualifications instead of maintaining copies of the diplomas or transcripts?
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.
Are individuals who have earned a high school diploma or equivalent prior to September 1, 1997, without evidence of further education (i.e. transcripts/diplomas), qualified to perform high complexity testing? What type of documentation is required?
Laboratory testing personnel who earned high school diplomas prior to September 1, 1997 are allowed to continue performing high complexity testing. Besides having records of the high school diploma or equivalent, the laboratory must retain documentation of training appropriate to the testing performed. If an individual was qualified to perform high complexity testing in the specialty of the laboratory prior to 1997 and continues to perform testing in that speciality in which they were trained and qualified, they are still qualified after 1997 to perform this testing. If the individual moves to a different area of the laboratory, they must now meet the current CLIA requirements for personnel performing high complexity testing with education and training equivalent to an associate degree.
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.
Do we need to have a copy of the diploma or transcript for all POCT personnel performing non-waived testing? Do these records need to be stored in the laboratory?
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, Biology, etc). A diploma that is not in a science-related field or simply states Bachelor of Science degree does not meet the requirements. 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 my state requires laboratory personnel licensure, is it necessary to also have a copy of the diploma on file?
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.
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.
Is a copy of an ASCP certificate acceptable documentation of educational qualifications?
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.
How many personnel records will my inspector review at my on-site inspection?
The number of personnel records to be examined is based upon a percentage of the total number of technical FTEs listed on the Laboratory 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.
What records should be available on-site to show the qualifications of the laboratory director?
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, 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.
What is required for evidence of education and training for military laboratory personnel performing non-waived testing?
Records must show that military staff have successfully completed an official U.S. military medical laboratory procedures raining 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).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.
Do all personnel records need to be retained in the personnel file or is it acceptable to keep some records in separate locations?
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.
Does a technologist with HEW certification qualify to perform high complexity testing?
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.
Does a Board of Regent degree satisfy the Bachelor's degree requirement for a Technical Consultant?
No, a Board of Regents Bachelor of Arts does not meet the requirement. The Board of Regents Bachelors 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 not designation of a major. CLIA regulations required 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.
Can we accept a high school diploma from an individual who was home schooled?
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.
Competency and Training
Who can assess competency for moderate and high complexity testing?
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.
Who can perform initial training for testing personnel?
Initial training can be performed by personnel who are competent in all phases of the testing process. 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.
How do I know if a test is categorized as moderate or high complexity?
Test complexity is determined by the FDA. Visit the FDA website.
Regarding checklist item GEN.54400—Personnel Records—Can we use a resume for the summary of training and experience?
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.
We are a multihospital system. Can we share copies of competency assessments between different locations?
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.
What is the difference between supervisory performance assessment and competency assessment/
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.
Florida Laboratory Specialty Licenses
How do I document the licensed specialties of testing personnel licensed in the State of Florida?
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:
- Clinical Chemistry
- Immunohematology/Blood Banking (Donor Processing)
- Molecular Pathology
- Oral Pathology
- Respiratory Therapy
What other resources available to help understand personnel qualifications and requirements?
Additional resources that you may wish to refer to include the following:
Please direct questions or comments to: