Maintaining Personnel Competency: New Requirements

Laboratory – Physician Office Resource, July 2016

Maintaining Personnel Competency: New Requirements


By Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP), Technical Writer /Quality Advisor, COLA Resources, Inc.




Knowledge of the impact of laboratory errors on patient care first reached the public arena during the 1960s and 1970s, resulting first in the passage of CLIA’67, and then CLIA ’88. Along with this, was the realization that safe and accurate laboratory testing could only be assured through a well-trained and competent staff.   Competency assessment is the means to confirm that training is effective, and that personnel are competent to perform laboratory testing that produces accurate and reliable results.


The Centers for Medicare and Medicaid Services (CMS) increased their emphasis on competency assessment because studies showed that laboratory errors with potential patient impact are often caused by a lack of competent personnel. Thus, an important component of CLIA '88 was a set of defined requirements for the documentation of initial personnel training and ongoing assessments of competency.


While the requirements are specific in what must be assessed, they did not specify how to implement some of these specific assessments in a laboratory setting. Thus, there was considerable variation in how these were implemented. To address this uncertainty and standardize implementation guidelines, in 2012 the government updated and specified the requirements for Competency assessment. Below are the six specific requirements for assessing laboratory personnel competency as set forth by CLIA[i]:


1. Direct observation of routine patient test performance;

2. Monitoring the recording and reporting of test results;

3. Review of intermediate test results, QC records, proficiency testing results, and preventive

   maintenance records;

4. Direct observation of performance of instrument maintenance and function checks;

5. Assessment of test performance by testing previously analyzed specimens, internal blind

   testing samples, or external proficiency testing samples;

6. Assessment of problem-solving skills.


Who Should Have Competency Assessments?[ii]


Current governmental mandates make it necessary to assess the competency of all laboratory workers who handle patient specimens. This not only  includes staff performing  non-waived testing, but all those who perform waived testing, as well as those who  perform phlebotomy duties, and those who are otherwise involved in the pre-and post analytical phases of testing


Clinical consultants, technical consultants/technical supervisors and general supervisors must also have their competency to perform regulatory responsibilities evaluated. However, the competency of lab directors is not assessed directly since they are held to separate standards and criteria to confirm that they are fulfilling the responsibilities of their positions. However, their competency must be assessed if they are performing Provider Performed Microscopy (PPM) testing.


It is just as important to have all front office personnel, including receptionists, medical assistants, secretaries, phlebotomists, couriers, and even the office manager, properly trained for  anything they do that affects any aspect of the laboratory operation. This is especially true for the pre-analytic phase of patient testing, as office staff is often involved in getting important patient information, ensuring that specimens are sent to the requested reference labs, and performing data entry on the office computer system.  In a Physician Office Lab, this multi-tasking may also extend to post-analytic activities such as receiving specimens collected off-site as well as receiving and filing of reference lab reports.  While not a CLIA requirement, good laboratory practice would also include competency assessment.  One possibility is to consider incorporation of competency assessments of laboratory-related activity into staff evaluations.


How does this differ from Performance Evaluations?[iii]


This is not the traditional “employee review”, which examines an individual’s initiative, interpersonal relationships, and work ethic although these are important attributes. The focus of this process is the individual’s ability to perform assigned tasks according to defined laboratory processes and procedures to assure accurate and reliable laboratory results. The review must address the competency of each individual to fulfill the duties and responsibilities

of their position.


Since Performance Evaluations often focus on non-laboratory duties and responsibilities, they have often been performed by non-laboratory personnel, especially in POLs and smaller laboratory operations. This has included: the office manager, the nursing supervisor, the HR person, or other managers in the practice. This was not unreasonable if the office saw the staff person as primarily a medical assistant with other duties. But, even then, the laboratory evaluation component should be by a qualified laboratory-competent person.


According to CLIA '88, the competency of testing personnel must be assessed semi-annually for the first year of patient testing, and annually thereafter. ­Competency must also be demonstrated whenever new testing methods, kits and/or instruments are added to your laboratory's test menu.


Who Is Qualified To Perform Competency Assessments?[iv]


A common pitfall for labs is the question of who can actually perform a competency assessment under the regulations. In a moderately complex laboratory, the person performing the competency assessment must be qualified as a technical consultant.

In a high complex laboratory, he or she must qualify as a technical supervisor. However, a technical supervisor may delegate the responsibility for competency assessments, in writing, to a general supervisor.

Personnel who perform point-of-care testing must also have their competency assessed. In this case, trained nurses may perform the assessment, but they must still meet the regulatory qualifications—at least a bachelor’s degree and 2 years’ of training or experience with non-waived testing. In addition, the laboratory director must delegate this task to a nurse in writing beforehand.




Suggestions for Implementing Competency Assessment Requirements[v]


  1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing

This method requires a specified individual to observe staff members performing the pre-analytic and analytic phases of testing according to written procedures. These procedures can be summarized in a direct observation checklist that addresses the critical steps of a specific procedure to help the observer evaluate each procedure.


  1. Monitoring the recording and reporting of test results

This can be accomplished by reviewing patient records in a laboratory information system, hard copy reports, or patient medical records.  


  1. Review of intermediate test results or worksheets, quality control records,

    proficiency testing results, and preventive maintenance records

The routine review of quality control records and preventive maintenance records should be part of every laboratory’s quality assessment plan. Proficiency test results are reviewed by performing personnel as well as by the laboratory director. Intermediate test results can be reviewed by specified personnel before patient results are reported. Look for documentation such as the date testing was performed, the initials of staff performing the testing, and documentation of kit performance by quality controls.


  1. Direct observation of performance of instrument maintenance and function


Again, an observation checklist with the critical steps summarized is an effective tool for documentation of this method.


  1. Assessment of test performance through testing previously analyzed specimens,

    internal blind testing samples or external proficiency testing samples


This requires the assessor to prepare unknown samples to be incorporated into the daily workload. These can be proficiency samples, blind samples, or previously analyzed samples. The other component of this method is setting an acceptable performance limit. Acceptable standard deviation, coefficient of variation, or CLIA ‘88 proficiency limits for the test that is assessed are valid methods for setting the acceptable performance limits.


  1. Assessment of problem solving skills

Although problem solving skills can be difficult to assess, they are used by laboratory staff every day. Problems encountered include inadequate or mislabeled specimens, troubleshooting instrumentation or reagent performance, and customer complaints. Documentation of how these common problems have been handled can be used to fulfill this assessment.





Documentation Is Required


Competency assessments must be documented, and this documentation must be maintained in the personnel files. This documentation must state whether competency was demonstrated, and what corrective actions were taken if competency was not demonstrated.  Competency assessments must be signed and dated by both the assessor and the employee.




[i] Centers for Medicare & Medicaid Services. What do I need to do to assess personnel competency? [brochure].

 Published November 2012. Accessed July 3, 2013.


[ii] I Rothenberg. New Requirements For Competency Assessment. March 2016.  AAFP-PT POL Insights.


[iii] I Rothenberg. New Requirements For Competency Assessment. March 2016.  AAFP-PT POL Insights.


[iv] B Malone. Competency Assessment:  Does the New CLIA Guidance Mean Big Changes? AACC Clinical Laboratory News. June 1, 2013.


[v]  API – PT EDUCATIONAL COMMENTARY – COMPETENCY ASSESSMENT IN THE CLINICAL LABORATORY: DEVELOPING A COMPETENCY ASSESSMENT PROGRAM. Educational commentary is provided through our affiliation with the American Society for Clinical Pathology (ASCP).



Irwin Z. Rothenbergis a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals. CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at or call 1-800-981-9883.




Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP)

Technical Writer/ Quality Advisor, COLA Resources, Inc.