Lecture 1 - Chapter 1 Quality Assurance and Regulation

Chapter 1: Quality Assurance and Regulation of the Blood Industry and Safety Issues in the Blood Bank

Objectives

• U1L1 – O1: State the goals of Quality Assurance (QA).

• U1L1 – O2: Define and contrast quality control and quality assurance.

• U1L1 – O3: Define the elements of record keeping; recognize acceptable/unacceptable practices.

• U1L1 – O4: Describe roles and responsibilities of key regulatory and accrediting agencies in blood banking including the FDA, AABB, and OSHA.

• U1L1 – O5: Explain the purpose, development, and key components of standard operating procedures (SOPs).

• U1L1 – O6: Understand monitoring of personnel competency and proficiency and the differences between these two.

Overview

• Primary Goal: Ensure safe transfusion of blood units.

• Requirements for Quality:

  • Well-constructed SOPs.

  • Well-trained personnel adhering to SOPs.

  • Comprehensive guidelines compliant with Joint Commission, FDA, AABB, and CAP.

• Consequences of Quality Failures:

  • Poor quality in blood collection, screening, or transfusion protocols can result in fatalities.

Regulatory Agencies

• Types:

  • Industrial: AABB (voluntary).

  • Federal: FDA, CMS (enforced by law).

  • State/Local: Varies (enforced by law).

• Functions:

  • Ensure quality products and patient safety (donors and recipients).

Food and Drug Administration (FDA)

• Role: Regulatory agency enforcing safety and efficacy in blood components and reagents.

• Regulations: Governed by the Code of Federal Regulations.

• Blood Classification: Classifies blood as a drug, requiring compliance with good manufacturing practices and quality assurance programs.

Accreditation Agencies

• AABB:

  • Voluntary accrediting agency.

  • Publishes guidelines for members (Technical Manual).

  • Compliance with Quality Essentials mandatory for accreditation since 1998.

Additional Regulatory Agencies

• More Agencies Include: CMS, HIPAA, CLIA Act of 1988.

Key Standards and Regulations

• Government Role: Ensures safety of blood supply.

• Agencies to Note:

  • FDA: Inspects blood banks and blood centers.

  • CAP: College of American Pathologists.

  • JCAHO: Joint Commission on Accreditation of Healthcare Organizations.

  • CLSI: Clinical Laboratory Standards Institute.

Distinction Between Blood Bank and Blood Center

• Blood Bank: Performs compatibility testing and prepares components for transfusion.

• Blood Center: Donation center for screening donors, drawing units, testing blood, and distributing components.

Elements of Quality Assurance

• Essential Elements:

  • Records and SOPs.

  • Personnel selection/training.

  • Validation, calibration, preventive maintenance, proficiency testing.

  • Supplier qualification.

  • Error management.

  • Process improvement and control.

  • Label control and internal auditing.

Safety Regulations

• Occupational Safety and Health Act (OSHA):

  • Ensures safe working conditions, enforced by OSHA.

• EPA: Involved with medical waste as per the Medical Waste Tracking Act of 1988.

Key Terms in Quality Assurance

• Quality Control: Manages the testing process and equipment monitoring.

• Quality Assurance: Encompasses the entire patient care process from test orders to patient treatment.

• Continuous Quality Improvement: Focuses on the review process to enhance care and reduce waste.

Records and Documents

• Importance: Record keeping is essential; if not documented, it’s considered as never happening.

• Audit Trail: Recreates every step in production and distribution of blood for error investigation.

• Guidelines:

  • Good record-keeping practices include using permanent ink, immediate data recording, and documenting corrections accurately.

  • Bad practices include use of correction fluid, non-permanent ink, or late recordings.

Computerized Record Guidelines

• System Requirements: Should trace original entries and document corrections.

• Backup Method: Must have a method for retrieving data for safety management.

Standard Operating Procedures (SOP)

• SOP Requirements: Describes tasks, documented in a standard format, follows CLSI guidelines.

Change Control

• Process: Ensures controlled management of changes to prevent oversight affecting quality.

• Challenge: Routine adaptations due to new technologies and regulatory changes.

Personnel Qualifications

• Selection Criteria: Must be defined for each position; job descriptions essential.

• Training: Provided at orientation or undergoing procedural changes; includes assessment of competence.

• Competency Assessment: Initial and periodic evaluations required for compliance.

Proficiency Testing

• Purpose: Ensures testing methods and equipment function properly, surveyed by accredited agencies.

• Types: Internal and external proficiency tests.

Error Management

• Includes: Mechanisms for detecting, documenting, and managing errors or incidents.

• Recalls: Issued for faulty products; must be reported to FDA for major issues.

Validation and Facilities

• Validation: Confirms process produces consistent products meeting specifications.

• Facilities Responsibilities:

  • Design compliance with cGMPs, housekeeping, equipment calibration.

  • Maintenance records needed for all instruments.

Quality Assessment of Supplies and Reagents

• Daily Testing: Specific reagents must be tested daily; tests must be documented.

• Receiving Documentation: Key details like date, manufacturer, and lot numbers must be logged.

Blood Bank Safety Programs

• Physical Space and PPE: Proper attire and safety measures required to protect employees.

• Decontamination Protocols: Regular cleaning and decontamination practices need to be in place for safety.

Chemical and Radiation Safety

• Chemical Handling: Governed by established classifications and Safety Data Sheets.

• Radiation Safety Program: Required training for personnel using irradiators to minimize exposure.

Waste Management

• Biohazardous Waste: Training in waste management necessary; materials must be correctly disposed of.

Documentation of Injuries and Education

• Injury Reporting: Completion of incident reports for all accidents further improves safety.

• Educational Requirements: OSHA mandates annual reviews of safety programs for employees.