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Blood Bank

Regulation

The operation of a Clinical Blood Bank is uniquely situated at the intersection of clinical laboratory medicine and pharmaceutical manufacturing. Unlike other laboratory sections that are primarily governed by the Clinical Laboratory Improvement Amendments (CLIA), Blood Bank regulates human blood as both a biological product and a drug. Consequently, regulatory oversight is rigorous, involving federal law (FDA), federal testing standards (CMS/CLIA), and peer-review accreditation (AABB/CAP). Compliance with these regulations is not optional; failure to comply can result in the revocation of the facility’s license to perform testing or issue blood products, effectively shutting down the hospital’s ability to perform surgeries or trauma care

Regulatory Agencies & Standards

The hierarchy of regulation ensures that minimum safety standards are met while encouraging best practices through voluntary accreditation. The laboratory scientist must understand which agency governs specific aspects of the workflow

Food & Drug Administration (FDA)

The FDA is the supreme regulatory authority for Blood Banks in the United States because blood is classified as a “drug” (it treats a condition) and a “biologic” (it comes from a living source). FDA regulations are Federal Law, codified in the Code of Federal Regulations (CFR), specifically Title 21 (21 CFR)

  • cGMP (Current Good Manufacturing Practices): The FDA mandates that Blood Banks operate under cGMP. This philosophy dictates that quality must be built into the manufacturing process, not just tested at the end. It requires strict adherence to Standard Operating Procedures (SOPs), comprehensive record-keeping, and facility suitability
  • Reportable Violations: Facilities must report accidents, errors, and fatalities that affect the safety, purity, or potency of a distributed blood product to the FDA (e.g., issuing a unit with the wrong blood type)

Centers for Medicare & Medicaid Services (CMS) & CLIA’88

CMS administers the Clinical Laboratory Improvement Amendments (CLIA’88). While the FDA focuses on the product, CLIA focuses on the testing process and the qualifications of the personnel

  • Certificate of Accreditation: All laboratories testing human specimens must hold a CLIA certificate
  • Inspections: CLIA grants “deemed status” to agencies like CAP and AABB to inspect laboratories on their behalf. If a lab passes a CAP inspection, they satisfy CLIA requirements

AABB (formerly American Association of Blood Banks)

AABB provides voluntary accreditation, but it is considered the “Gold Standard” for the industry. AABB Standards for Blood Banks and Transfusion Services often exceed minimum federal requirements. Most major hospitals seek AABB accreditation to demonstrate the highest level of quality

College of American Pathologists (CAP)

CAP is a peer-review accrediting agency with “deemed status” from CMS. CAP utilizes detailed checklists (e.g., the Transfusion Medicine Checklist) to inspect the laboratory every two years. CAP standards emphasize the entire testing lifecycle, from specimen collection to result reporting

Proficiency Testing (PT)

Proficiency Testing, also known as External Quality Assessment (EQA), is a federal mandate under CLIA’88. It acts as a “report card” for the laboratory, verifying that the lab’s results are accurate compared to peer laboratories using the same methods

The Proficiency Testing (PT) Process

  • Frequency: PT must be performed at least three times per year (three “events”), usually with five samples per event
  • Strict Prohibition on Communication: The most critical rule of PT is that the laboratory must not communicate with any other laboratory regarding the results until after the submission deadline. Sharing results constitutes “PT Referral,” which can lead to immediate revocation of the lab’s license and a ban on the laboratory director and owner for two years
  • Routine Workflow: PT samples must be tested in the same manner as patient samples. They should not be assigned to the “best” laboratory scientist or tested multiple times (unless patient samples are also tested multiple times). This ensures the assessment reflects the lab’s actual daily performance

Grading & Failure

  • Target Values: Results are graded against a consensus of peer laboratories
  • Unsatisfactory Performance: Failure to achieve a passing score (usually 80% or 100% for ABO/Rh) requires immediate investigation and documented corrective action
  • Suspension of Testing: Repeated unsuccessful performance (e.g., two out of three consecutive events) requires the laboratory to cease testing for that specific analyte until reinstatement requirements are met

Alternative Assessment

If a commercial PT program is not available for a specific test (e.g., a rare antibody titer), the lab must verify accuracy at least twice a year using an alternative method. Common methods include:

  • Split-Sample Testing: Sending a sample to a reference laboratory and comparing results
  • Blind Testing: Re-testing a previously analyzed sample where the result is known by the supervisor but blinded to the tech

Competency Assessment

While Proficiency Testing validates the laboratory, Competency Assessment validates the individual laboratory scientist. Under CLIA, the Laboratory Director is responsible for ensuring all personnel are competent to perform their assigned duties. This is a formalized, documented process

Timing of Assessment

  • New Employees: Competency must be assessed semiannually (twice) during the first year of employment
  • Ongoing Employees: After the first year, competency must be assessed annually

The Six Elements of Competency

CLIA defines six specific methods that must be used to assess competency. A simple written quiz is insufficient; the assessment must include the following:

  1. Direct Observation of Testing: Watching the employee perform the test (e.g., observing the tube shaking technique and grading of agglutination)
  2. Monitoring Recording and Reporting: Reviewing the employee’s worksheets or LIS entries to ensure results are transcribed correctly
  3. Review of Test Results: Examining intermediate results, worksheets, and QC records generated by the employee
  4. Direct Observation of Maintenance: Watching the employee perform instrument maintenance or function checks (e.g., cell washer maintenance)
  5. Proficiency Testing/Known Samples: Having the employee test a sample with a known result (e.g., a blind sample or a PT sample) to verify accuracy
  6. Problem Solving: Assessing the employee’s ability to troubleshoot (e.g., “What do you do if the Check Cells are negative?” or “How do you resolve an ABO discrepancy?”)

Document Control & Standard Operating Procedures (SOPs)

Regulations require that all policies, processes, and procedures be documented. In Blood Bank, “if it isn’t written down, it didn’t happen”

  • SOP Structure: Procedures must follow the Clinical and Laboratory Standards Institute (CLSI) format, including title, principle, specimen requirements, reagents, step-by-step instructions, interpretation, and references
  • Control of Records: Documents must be approved and signed by the Medical Director before implementation. Obsolete documents must be removed from the bench immediately to prevent the use of outdated instructions
  • Record Retention: Blood Bank records have distinct retention requirements to ensure traceability. For example, records tracing a unit of blood from source to final disposition must be kept for a minimum of 10 years (or longer depending on state law), whereas indefinite retention is often required for records regarding patients with permanent deferrals or unexpected antibodies