Tool Box Chock-Full of Skills

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High-performing laboratories realize that their quality and risk management success depends on their employees’ competence.

Competent employees have the ability to do the job properly. Conducting competency assessments offers an opportunity to provide continuing education and performance feedback to employees and to document valuable objective information for performance evaluations. Evaluations should and can be used as a positive experience that helps to ensure that employees and employers can perform assigned tasks. Another benefit of ongoing assessments of employee competency skills promotes service delivery improvement.

Well-defined laboratory competencies assist management in measuring patterns of abilities, behaviors, knowledge, skills and other characteristics of
their staff. These performance attributes are needed in order to achieve work tasks successfully. The clarity of expected skills assists in the specification of the “how” during the performing of job functions. In other words, what the lab worker needs to be, do and have in order to be successful in their tasks.

Clear competencies create winning environment

High-performing laboratories realize that their quality and risk management success depends on how capable their employees are. Management recognizes that the clinical and nonclinical education with which the employee was hired doesn’t necessarily “fully” equip laboratorians with the appropriate skills to tackle the new technological and other advancements. In order to meet the current and futuristic challenges, the solution lies in ongoing skills evaluation and training.

Regulatory oversight of personnel assessment

Accreditation and regulatory agencies mandate that human resources ensure that permanent and contractual employees have the required competency skills and that those skills are assessed at specified timeframes. Laboratories are expected to comply with the guidelines of federal regulations and national accrediting agencies. One the key principles is that a system must be in place that will verify, in a documented format, the initial training of staff and ongoing skills assessment of competence.

Competency assessment in the clinical laboratory, as mandated in U.S. law since 1988 as part of CLIA ’88, is published in the Federal Register as part of the Code of Federal Regulations (CFR). The CFR defines the requirements for initial training verification, initial competency assessment and ongoing competency assessments of laboratory personnel. As a recap of the regulation titles basics, the number “42” indicates “Public Health, the “493” indicates “Laboratory Requirements,” and the series of numbers beginning with the “1300s” are the qualifications section standards.

CLIA’s expectations for skills assessment

CLIA’s expectations, as they relate to competency assessments, are to ensure that each laboratory employee fulfills their duties as required by federal regulation.

To accomplish this, the agency puts promotes the following six procedures as minimal regulatory requirements for assessment of skills for all lab staff performing laboratory testing:

  1. Direct observations of routine patient test performance occurs, including patient preparation, if applicable, specimen handling, processing and testing
  2.  Monitoring the recording and reporting of test results
  3. Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records
  4. Direct observations of performance of instrument maintenance and function checks
  5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples

Assessment of problem solving skills

CLIA encourages that a comprehensive competency assessment occurs, which includes, but is not limited to the six procedures above. In addition, the assessment must be performed by testing personnel for each test that the staff member has received approval from the laboratory director to perform.1

Enhancements to skill tool box

All laboratory employees should have a well-stocked tool box of skills. And over the past three years, public health and other professionals collectively joined forces in a competency project to name what tools should be in it.

Just recently, the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) took on the quest to reduce risk, while, at the same, time boosting positive laboratory outcomes by encouraging upgrades to expected competency guidelines.

In 2012, the two agencies sponsored a two year workforce project to review and develop specialized skill level areas, which are divided into four levels of proficiency: beginner, competent, proficient and expert. In addition, during the initial 2012 work, they designed 15 laboratory domain areas to include:

  • Quality Management System
  • Ethics
  • Management and Leadership
  • Communication
  • Security
  • Emergency Management and Response
  • Workforce Training
  • General Laboratory Practice
  • Safety
  • Surveillance
  • Informatics
  • Microbiology
  • Chemistry
  • Bioinformatics
  • Research

The domains reach across settings, including, but not limited to governmental public health, environmental labs and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related services that protect human populations against infectious diseases, food-borne and water-borne diseases, environmental hazards, treatable hereditary disorders and natural and human-made public health emergencies.

During April 2014, a Harmonization of Domains Workgroup met to review major changes that could be drafted into competencies to address skill gaps and overlaps in skills. In addition, the workgroup reviewed content and inconsistencies in approach and language among the competency domains. The members then split into small teams and met via teleconference from April through July 2014 to finalize the competency domains. The final draft of the competency guidelines was reviewed by the CDC and APHL Steering Committee in October 2014. The fine-tuned competency guidelines were approved by CDC in February 2015 for distribution.

During the month of May 2015, the result of the 170 member CDC and APHL workgroup endorsed the CDC release of a Morbidity and Mortality Weekly Report (MMWR) publication titled, “Competency Guidelines for Public Health Laboratory Professionals (Supplement Volume 64 / Number 1).”2

The CDC and APHL competency guidelines clearly outline the knowledge, skills and abilities necessary for public health laboratory (PHL) workers. The guidelines attempt to assist professionals to deliver the core lab services of PHLs in an effective and efficient manner.

Competencies support quality improvement initiatives

Media press and literature is loaded with accounts of unintended adverse results due to lab errors. Erroneous incidents have been traced back to numerous causes, such as inadequate staff schedules, demanding workloads and poor verbal and written communication practices. But quality audits and inspections also reveal that insufficiently trained and incompetent employees also play a role in error trends.

The hope among compliance regulatory professionals and other clinical, research and public health  professionals is that the new clearly defined competencies derived from the CDC and APHL sponsored project will aid in a reduction of quality assurance & control (QA&C) and performance improvement (PI) lab errors.

Guidelines can be applied to other lab settings

The new competency guidelines were developed specifically for the PHL community, but the document is worth a look for all laboratorians, regardless of work setting.  The clearly defined competency strategy encourages a broader application to other professionals. Most will find that the layout and content of the document will enable employees to be more proactive beyond their individual roles, which ultimately will be of value to our customers and stakeholders.


References:

  1. Clinical Laboratory Improvement Amendments (CLIA). Regulations and Guidance. https://www.cms.gov/regulations-and-guidance/regulations-and-guidance.html.
  2. Competency Guidelines for Public health Laboratory Professionals: CDC and the Association of Public Health Laboratories. Supplement: May 15, 2015/64(01). http://www.cdc.gov/mmwr/preview/mmwrhtml/su6401a1.htm.

Suggested Readings:

Elder, B. L., and S. E. Sharp. 2003. Competency Assessment in the Clinical Microbiology Laboratory. American Society for Microbiology Press, Washington, D.C.

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About Author

Eleanor Wolfram, MS

Eleanor Wolfram, MS, is a certified QA&C auditor.

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