| Monday, January 01, 0001
As Healthcare Professionals we often hear the terms training and competency used when referring to staff performance or education. These terms are often used interchangeably and incorrectly. Their basic meanings are similar but their applications are very different. We will clearly characterize each term as they relate to laboratory testing.
Competency is an ability or skill, as defined by Miriam Webster Learner's Dictionary1. CMS further clarifies it as the "ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly."2
The Dictionary definition of Training is "a process by which someone is taught the skills that are needed for an art, profession, or job."3 According to CMS, "Training may include, but is not limited to, attendance at:
- Seminars given by experts in the field, e.g., a lecture about antibiotic resistance given by the infection control officer of a local hospital;
- On-site or off-site instrument trainings given by a manufacturer, e.g., a week-long training course given at the manufacturer's headquarters, or training by a manufacturer's technical representative on an instrument purchased by a laboratory;
- Technical training sessions, workshops, or conferences given by a professional laboratory organization, e.g., CAP, ASMT, ACC, and ASCT;
- Technical education classes or specialty courses that include hands-on test performance, e.g., parasitology, bacteriology, cytology, given by CDC, a State Health Department, or professional laboratory organizations;
- A formal laboratory training program; or
- In services offered by a local hospital laboratory staff, pathologist, or medical technologist to a physician's office personnel.
Documentation may consist of, but is not limited to, letters from training programs or employers, attestation statements by the laboratory director, a log sheet initialed by the attendees indicating attendance at a training session/in service, certificates from organizations providing the training session, workshop, conference, specialty course."4
Training is also correlated with education. As defined by CMS, testing personnel may attend a formal laboratory training program or have education provided on the job. The level of education required is dependent upon the level of testing that the individual can perform.
To be clear, once trained on a skill personnel can then be assessed for competency on that skill. Simply having been instructed on a process or procedure does not necessarily ensure the task is performed correctly. The commonly used adage "Practice makes perfect", can be taken further to include, "Perfect practice makes perfect performance." Once performance has been perfected, competency can be assessed, and if adequate, patient testing can be performed.
Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by federal regulation5. Even among larger laboratories with more formal structure, there has historically been little uniformity as to what constituted a valid assessment of competency. In recent years, there has been a regulatory emphasis on competency assessment, as an important quality tool to reduce laboratory errors.
WHO SHOULD PARTICIPATE IN A COMPETENCY ASSESSMENT?
Personnel should not be offended or insulted when asked to participate in a Competency Assessment. CMS Certification and many Accrediting Organizations (AO) Criteria include Competency Assessment as part of the laboratory's Certification and/or Accreditation requirements. Employee Competency Assessments and evaluations are required of testing personnel that perform clinical laboratory test(s) that are subject to 42 CFR Part 493.12356. This includes those laboratory facilities that are covered under a HHS CMS CLIA Certificate (e.g., Certificates of Registration/Compliance/Accreditation) that perform non-waived tests, predominantly. The new CMS IQCP Guidelines include Competency Assessments as part of the laboratory's Individual Quality Control Plan7. As the laboratory community makes the transition from EQC to IQCP, competency assessment is likely to be a key component of many Individualized Quality Control Plans risk assessment.
In determining who should participate in a Competency Assessment, the decision is based on a few factors. Some AO criteria mandates that "All staff are to be included in this process from personnel involved in specimen collection and processing to those responsible for supervision and compliance."8 Under CLIA regulations, all testing personnel must have their training documented and their competency verified9. Competency assessment is also required for other positions, such as Technical Consultants, Technical Supervisors, and General Supervisors.
Competency assessment for these individuals must address their ability to fulfill the CLIA defined responsibilities for these positions. If persons serving in these supervisory roles are also testing personnel, they must undergo competency assessment for test performance as well. Laboratory Directors are not required to undergo competency assessment, but must fulfill the CLIA-defined responsibilities of this critical position. This is typically evaluated during the on-site survey.
CLIA currently does not require Testing Personnel who perform waived testing to participate in Competency Assessments, but COLA, the premier private Accrediting Organization in the US, does require competency assessments for all testing personnel performing waived testing.
COLA does note in their recommendations, "Even though CLIA has no specific requirements for personnel performing waived testing, you need to ensure that patient testing results are correct to assist in making an accurate patient diagnosis. You will need to ensure that testing personnel are following all manufacturers' instructions. Testing personnel who are properly trained and performing the test correctly will aid the physician/provider in making an accurate patient diagnosis."10
As healthcare professionals, we should always strive for excellence in providing patient care, even if the test system is considered waived. As defined by CLIA, waived tests are categorized as "simple laboratory examinations and procedures that have an insignificant risk of an erroneous result."11 This means that the test system itself is simple in design, but the results that are being reported are equally significant to non-waived test results in patient care.
WHEN SHOULD A COMPETENCY ASSESSMENT BE PERFORMED?
"Evaluations should occur semi-annually for the first year and annually thereafter for all testing personnel, supervisors and technical consultants."12 More importantly CMS and many AO's mandate that "Personnel must not report test results for patient specimens until, training is complete and competency is verified for each test procedure they perform."13 In other words, no Competency Assessment, no testing can be performed!
WHAT IS GOING TO BE ASSESSED?
Methods of competency assessment must include, but are not limited to :14
- Direct observation of routine patient test performance;
- Monitoring the recording and reporting of test results;
- Review of intermediate test results or worksheets;
- Direct observation of instrument maintenance;
- Blind sample testing (such as Proficiency Testing); and
- Assessment of problem solving skills.
Competency Assessment, which includes the six methods, must be performed for testing personnel for each test that the individual is approved by the laboratory director
to perform. It is also good to know that Proficiency Testing (PT) performance may be used as part of the competency assessment; however use of PT performance alone is not sufficient to meet all six required methods.
To ensure personnel can successfully complete a Competency Assessment, proper training from the start is fundamental. For quality test performance, training must ensure that all testing personnel are familiar with the following for each test procedure:15
- The test name and purpose of the test
- The equipment necessary to perform the test
- Specimen collection and handling
- Preparation, labeling, use, and storage of reagents, standards, and controls
- Special requirements, safety procedures, etc.
- Instrument maintenance, function checks, and calibration, when applicable
- Step-by-step performance of the test procedure
- Quality control procedures including what constitutes acceptable results and when to report patients
- How to recognize and interpret inconsistent results and test system problems and perform troubleshooting
- Recommended corrective action when controls are unacceptable
- Necessary calculations and derivation of results, when applicable
- Reference ranges and critical values
- Result reporting
- Quality assessment procedures
Training and personnel evaluation are not the same as competency assessment. While training is important to ensure competency, training is a process to provide and develop the knowledge, skills, and behaviors to meet established requirements.
Documentation of training does not satisfy the requirement for documented competency assessment. Personnel evaluations evaluate other behaviors and attributes as they relate to the position or job (such as internal or external customer service). Competency is the application of the knowledge, skills and behaviors for performance.
The difference between training and competency is that training happens before the individual begins testing and competency assessment confirms that the individual is doing the testing correctly.16
In summary, by taking the necessary documented steps to properly train and then assess the competency of testing personnel, laboratories ensure regulatory and Accreditation compliance. Testing patient samples and producing accurate results is critical for proper patient care. And a competent and capable laboratory staff is critical before patient samples are tested.
Maria S. Hardy is a Technical Writer for COLA's Education 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 Symposia for Clinical Laboratories and Workshops, providing live educational sessions and interactive seminars with leading industry organizations. For more information, visit their website at www.criedu.org, or call 1-800-981-9883.
2,5,7,10,12 CLIA Brochure #10 - What Do I Need to Do to Assess Personnel Competency? http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf
4CMS 493.1423 Standard; Testing personnel qualifications. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/apcsubm.pdf
5,6,9 CMS 493.1235 Standard: Personnel competency assessment policies. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/apcsubk1.pdf
7Implementing the Individualized Quality Control Plan (IQCP) for Clinical Laboratory Improvement Amendment http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter12_20-.pdf
8,10 COLA Accreditation Manual (July 2013) PERSONNEL REQUIREMENTS:PER 5 p.65
11CLIA – How to Obtain a Certificate of Waiver http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf
12,13 COLA Accreditation Manual (July 2013) PERSONNEL REQUIREMENTS:WAV 6 R p.105
14,15,16 COLA LabGuide 16 Personnel Training & Competency Assessment www.colacentral.com