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Blood Bank

Performance Standards

In the clinical laboratory, ensuring that personnel are qualified and competent is not just a matter of good management; it is a federal requirement. The Clinical Laboratory Improvement Amendments of 1988 (CLIA’88), along with accrediting bodies like CAP (College of American Pathologists) and AABB (Association for the Advancement of Blood & Biotherapies), mandate a structured system of performance standards. This system includes Initial Training, Periodic Competency Assessment, and Continuing Education. For Blood Bank administrator, this framework is the primary defense against errors that could lead to transfusion-associated morbidity or mortality

The Hierarchy of Personnel Qualifications

Before an employee can even be trained, they must meet specific educational requirements defined by CLIA based on the complexity of testing they perform. Blood Bank testing is almost exclusively classified as High Complexity

  • Testing Personnel: Must possess at least an Associate degree (MLT) or Bachelor’s degree (MLS/MT) in a chemical, physical, or biological science. They are responsible for specimen processing, test performance, and reporting results
  • General Supervisor: Must be accessible to testing personnel at all times testing is performed to provide on-site supervision
  • Technical Supervisor: Responsible for the technical and scientific oversight of the laboratory (e.g., selecting test methods, validating new assays)
  • Medical Director (CLIA Laboratory Director): A physician (Pathologist) or PhD who holds ultimate legal responsibility for all operations, safety, and personnel competency

Initial Training & Orientation

When a new employee is hired, they enter a probationary “Training Phase.” During this time, they cannot report patient results unsupervised

Structure of the Training Program

  • Standard Operating Procedures (SOPs): The trainee must read and acknowledge the procedure manuals for every test they will perform
  • Observation: The trainee watches a trainer perform the task
  • Supervised Performance: The trainee performs the task while the trainer watches
  • Independent Performance: The trainee performs the task alone, and the results are reviewed by the trainer before release

Documentation (The Training Checklist)

  • Every task (e.g., “Daily Reagent QC,” “ABO/Rh Tube Method,” “Thawing Plasma”) must be listed on a checklist
  • Sign-Off: Both the Trainer and the Trainee must date and initial each item. This document proves that the employee was formally taught how to do the job
  • Conclusion: The Medical Director (or designee) must sign a statement verifying that training is complete and the employee is approved to perform patient testing

Competency Assessment (The CLIA “Big 6”)

Competency assessment is distinct from training. Training teaches you how to do it; Competency confirms you still do it correctly

Frequency

  • New Employees: Competency must be assessed Semiannually (at 6 months) during the first year
  • Ongoing: Competency must be assessed Annually thereafter

The Six Required Elements

CLIA specifically mandates how competency must be assessed. The laboratory cannot just give a written quiz; they must utilize all six of the following methods for each test system:

  1. Direct Observation of Routine Patient Test Performance: Watching the laboratory scientist perform the test from start to finish (e.g., watching them perform an antibody screen)
  2. Monitoring the Recording and Reporting of Test Results: verifying that the laboratory scientist enters results correctly into the LIS and handles critical values (read-backs) appropriately
  3. Review of Intermediate Test Results or Worksheets: Checking old records to ensure QC was documented, lot numbers were recorded, and interpretations matched the reaction grades
  4. Direct Observation of Instrument Maintenance/Function Checks: Watching the laboratory scientist perform daily/weekly maintenance (e.g., cleaning the cell washer, changing analyzer tubing)
  5. Assessment of Test Performance via Proficiency Testing (PT): Having the laboratory scientist run blind samples (e.g., CAP Survey samples) and achieving the correct result
  6. Assessment of Problem Solving Skills: Usually accomplished via a quiz or case study (“What would you do if the daily QC failed?”)
  • Note on “Waived” Testing: If a test is waived (e.g., urine dipstick, though rare in Blood Bank), the 6 elements are not strictly required by CLIA, but good practice dictates following them

Proficiency Testing (PT)

Proficiency Testing serves as an external validation of both the laboratory’s method and the personnel’s performance

  • Process: An external agency (CAP, API) sends unknown samples to the lab 3 times a year
  • Testing: The samples must be integrated into the routine workflow and tested by the staff who normally perform patient testing. Strict Rule The lab cannot send PT samples to a reference lab or consult with another hospital. Doing so is considered “PT Referral” and results in severe penalties (revocation of CLIA license)
  • Evaluation: The lab’s results are graded against peer groups
    • Passing: Usually 80% or 100% for ABO/Rh
    • Failure: If the lab fails a survey event (e.g., <80%), they must perform a Root Cause Analysis. Was it a clerical error? A bad reagent? A training issue?
    • Sanctions: Repeated failure (2 out of 3 events) leads to “Cease Testing” orders from CMS

Continuing Education (CE)

Medicine changes. Personnel must demonstrate that they are staying current with new standards and technologies

  • Requirements
    • CAP: Generally requires a defined number of CE hours per year
    • Certification Maintenance (ASCP CMP): laboratory scientists certified after 2004 must earn 36 CE credits every 3 years to maintain their credential (including 1 point in Safety and 2 in Blood Bank)
  • Sources: In-services, webinars, reading journal articles, or attending conferences
  • Documentation: The laboratory manager maintains a file of CE certificates for every employee to present to inspectors

Performance Improvement Plans (PIPs)

When an employee fails a competency assessment or makes a significant error (e.g., an ABO mistype), the administration must initiate remedial action

  • Immediate Action: The employee is usually suspended from performing that specific test until retraining occurs
  • Retraining: The employee repeats the initial training module (SOP review, observation, supervised practice)
  • Re-assessment: The employee must pass a new competency assessment before being allowed to resume patient testing
  • Documentation: This “Loop” (Error \(\rightarrow\) Retraining \(\rightarrow\) Re-assessment) must be fully documented in the personnel file. If it is not written down, in the eyes of the inspector, the corrective action never happened