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Hematology

Performance Standards

Ensuring that laboratory personnel are qualified and competent to perform patient testing is not just a best practice; it is a federal mandate. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) and accreditation standards (CAP, TJC), the laboratory administration must rigorously document the “lifecycle” of an employee’s proficiency. This process moves from the initial verification of credentials to training, and finally to the ongoing assessment of competency. In Hematology, where morphological identification is subjective and critical, these standards are strictly enforced

Personnel Qualifications (CLIA Subpart M)

Before an employee can be hired or trained, they must meet specific educational requirements based on the complexity of testing they will perform. Most Hematology and Coagulation testing is classified as High Complexity (e.g., Manual Differentials, Bone Marrow analysis) or Moderate Complexity (e.g., Automated CBC)

  • Testing Personnel (High Complexity)
    • Minimum requirement: Associate degree in laboratory science (MLT) or medical laboratory science (MLS)
    • Note: While CLIA sets the minimum at an Associate degree, many institutions require a Bachelor’s degree (MLS/MT) for high-complexity roles or supervisory positions
  • Primary Source Verification: The laboratory manager cannot simply take the applicant’s word for it. They must verify education by obtaining an official transcript directly from the university. Diplomas are generally not sufficient for inspection purposes
  • License vs. Certification
    • Certification (ASCP, AMT): A voluntary professional credential proving knowledge (e.g., laboratory scientist(ASCP)). While highly preferred, it is not a federal requirement for CLIA, though some states mandate it
    • Licensure: A state-mandated legal requirement to practice (e.g., California, Florida, New York). The lab must maintain copies of current licenses for all staff

Training & Orientation

Training is the process of teaching an employee how to perform a task. It occurs upon hiring or when a new instrument/method is introduced

  • Standard Operating Procedure (SOP): Training must be based directly on the lab’s specific SOPs, not the manufacturer’s manual or “tribal knowledge” (how the senior laboratory scientist likes to do it)
  • The Training Checklist: Documentation is key. A checklist must itemize every critical task (e.g., “Changes Lyse Reagent,” “Performs Calibration,” “Identifies Malaria”)
  • Documentation: Both the Trainer and the Trainee must initial and date each item
  • Conclusion of Training: The employee cannot touch patient samples until the training period is formally closed and they have been deemed competent. A “Statement of Competency” must be signed by the Technical Consultant/Supervisor

Competency Assessment (The 6 Elements)

Competency Assessment is the verification that the employee retains the knowledge and skill to perform the test accurately after training is complete. CLIA mandates a very specific schedule and method for this

  • Frequency
    • New Employees: Competency must be assessed Semiannually (at 6 months) during the first year of employment
    • Ongoing: After the first year, competency must be assessed Annually
  • The 6 Required Elements of Competency: CLIA mandates that the assessment must include all six of the following methods for each test system (e.g., one assessment for the Sysmex, one for the Stago, one for the Microscope):
    1. Direct Observation of Testing: Watching the employee perform the patient test (from sample loading to result verification)
    2. Monitoring the Recording and Reporting of Results: Reviewing worksheets or LIS logs to ensure results are entered correctly and critical values are documented
    3. Review of Test Performance Records: Checking the employee’s QC logs, maintenance records, and proficiency testing signatures
    4. Direct Observation of Maintenance: Watching the employee perform instrument maintenance (e.g., cleaning the aperture or changing a probe)
    5. Assessment of Test Performance (Proficiency Testing): Having the employee run a blind sample (PT sample or previously analyzed patient) to see if they get the correct answer
    6. Assessment of Problem Solving: Giving the employee a written quiz or a case scenario (e.g., “What do you do if the QC fails twice?”) to test troubleshooting skills

Competency in Hematology Morphology

Assessing competency in manual differentials is unique because it is subjective. A simple quiz is often insufficient

  • The Cell Identification Quiz: Staff are typically shown a set of digital images or glass slides with pre-identified cells (e.g., Blasts, Reactive Lymphs, Plasmodium). They must identify them correctly
  • Grading Consistency: To ensure standardization, the manager may have all staff perform a differential on the same difficult slide. The individual results are compared to the “consensus” or the pathologist’s review. Outliers (e.g., one laboratory scientist calling “Monocytes” what everyone else calls “Reactive Lymphs”) trigger remedial training

Proficiency Testing (PT) Performance

Proficiency Testing (External Quality Assessment) serves as a check on both the laboratory’s accuracy and the individual personnel’s performance

  • Rotation: PT samples (from CAP or API) should not be performed by the same “Lead Tech” every time. They must be rotated among all testing personnel who perform the test
  • Attestation: The individual who performs the PT must sign the attestation statement confirming that they tested the sample exactly like a patient sample, without consulting others
  • Corrective Action: If an employee fails a PT event (e.g., misidentifies a cell or gets a result outside 2 SD), they must undergo documented Remedial Training and re-assessment before they can resume patient testing for that analyte

Personnel Files

For inspection purposes (CAP/Joint Commission), the laboratory must maintain a continuously updated file for every employee containing:

  • Copy of Diploma/Transcript
  • Copy of current License/Certification
  • Job Description (signed)
  • Training Checklists
  • Competency Assessments (Initial, 6-month, and all Annuals)
  • Color Blindness Test (critical for Hematology staining and Microbiology)
  • Continuing Education (CE) credits (proof of ongoing learning)