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

FDA

Food and Drug Administrations (FD)

regulatory agency (required)

enforces regulations to ensure the safety and efficacy of blood and blood components and reagents used or manufactured by blood establishments

Code of Federal Regulations contains the requirements for safety and efficacy

AABB

Association for Advancement of Blood & Biotherapies

voluntary

publishes guidelines for members seeking accreditation

standards for blood banks and transfusion services provides the basis for the inspection and accreditation of blood banks

compliance with quality essentials is mandatory for blood bank accreditation (since 1998)

SOPs

Standard operating procedures

Safety Regulations

Occupational Safety and Health Act

• enforced by Occupational Safety and Health Administrations (OSHA)

Environmental Protection Agency (EPA)

• Medical Waste Tracking Act of 1998

What is quality assurance (QA)

compromises the combined activities performed by an organization to ensure the quality of products and services

QA responsibilities

compliance, SOPs, specifications and validation protocols, development, review, and approval of training programs, investigation of product recalls, errors, and complaints, coordination of internal quality auditing programs

What is document control

should specify and describe acceptable media to be used, types of documents to be kept, and record-retention intervals

all record systems must be described in the SOPs

What is record keeping

an audit trail recreates every step in the production and distribution of a unit of blood and all its components

manual record guidelines

good and bad

good = permanent ink, immediately after task, marking date and initials on correction

computerized record guidelines

a computer system should be able to trace the original entry and person making the correction

processes and procedures support management of computer systems and the backup of data

a backup method for retrieving data must be available

Standard Operating Procedures flow

SOPs → Principle or purpose → Specimen requirements → Supplies, reagents, and equipment, QC, Procedure instructions, Interpretations and reporting, References

What is change control

is a process that develops or changes existing processes or procedures

changes need to be controlled to prevent oversights that could affect the organization

What is validation

establishes that a specific process consistently produces a product that meets predetermined specifications

a process or system should be validated before it is implemented

3 examples of Personnel Qualifications

1. selection criteria and job descriptions

   • criteria must be identified for each typ of position

   • job description describes the tasks and skills

2. training

   • provided during new employee orientation, whenever there are procedural changes, or whenever an employee is performing poorly

3. competency assessment

   • initial competency evaluates an employee’s knowledge and skills during training

   • periodic competency determines whether an employee has maintained the knowledge and skills

Supplier qualifications

BBs and suppliers have written agreements that specify expectations

some facilities choose to audit suppliers

facilities should have procedures for inspecting and testing incoming materials

2 methods of error management

1. root-cause analysis

   • investigation and identification of factors contributing to an error

   • ensures continuous quality improvement

   • major errors involving a donor or patient are reported to the FDA

2. Recalls

   • issued by manufacturers (or the FDA) to remove faulty products

   • recalls are classified based on degree of danger

Facility design and housekeeping

work area should be organized and free of clutter

area should be clean

equipment

calibration - standardizes an instrument

QC - determines accuracy and precision of testing components

preventative maintenance - periodic maintenance enhances reliability and avoids costly repairs

Proficiency testing

required component of the QA program

ensures test methods and equipment are working properly

surveys are prepared by accredited agencies…CAP

BB label control purpose

to avoid mislabeling errors

it is the QAs departments responsibility to inspect and approve all labels

Standard Precuations

CDC, includes policies that treat all body substances as potentially infectious, incorporates universal precautions and body substance isolation together

Universal Precautions

OSHA term 1991

defines policies of treating all body substances as potentially infectious and applying safety measures to reduce possible exposure

examples of BB safety

phsyical space, lab attire, PPE, safety cabinets, gloves and hand hygiene, warning signs

decontamination in the blood bank

1:10 dilution of sodium hypochlorite (bleach)

Chemicals classified by…

corrosivenes, ignitability, reactivity, and toxicity

what must toxic susbtances be accompanied by

material safety data sheet (MSDS)

MSDS required by OSHA

Radiation safety

blood banks use gamma irradiators for irradiation of blood components

Nuclear Regulatory Commission requires training for all personnel using irradiators

Employees are properly trained and monitored for exposure

Biohazardous waste

policies for waste

personnel must be trained

designated, leak-proof containers

wastes containing blood and body fluids are autoclaved

BB storage

blood and blood components are separate from reagents and specimen

BB transportation

specimens transported in plastic bags within institution

shipping of specimens to or from the laboratory must follow regulations of DOT and USPS

If personal injury occurs…

accident report MUST be completed when any injuries or possible injuries occur

investigation of a minor accident may prevent a major accident later

personnel should report all incidents, no matter how insignificant

Employee education

OSHA and other regulatory and accrediting agencies mandate employee education

BB safety should be reviewed with new employees before they begin work

safety program to be reviewed annually by each employee