QA/QC

What is the CFR?

• Code of federal regulations

• rules and regulations that are published in the federal register

What is the FDA?

• food and drug administration

• federal agency responsible for monitoring safety standards in the food and drug industries

What is GMP?

• good manufacturing processes

• system to ensure products are consistently produced and controlled according to quality standards

What the HCFA?

• Health Care financing administration

• federal agency that establishes standards for medical providers that require compliance to meet certification requirements, now referred to as CMS (centers for medicare and medicaid services)

What is the JC?

• the joint commission

• an independent, non-profit group that administers accreditation programs and develops performance standards for hospitals and other healthcare related organizations

What is an SOP?

• standard operating procedure

• established methods to be followed routinely for performance of designated procedures

What is OSHA?

• the occupational safety and health administration

• an agency within the us department of labor, responsible for establishing and enforcing safety and health standards in the workplace

• conducts periodic, random inspections, as well inspections in response to complaints

What agency inspects laboratories are part of a larger healthcare organization?

Joint Commission

What three agencies are responsible for CLIA?

• FDA: categorizes test complexity and develops rules for complexity categories

• HCFA: certificates, inspections, enforces regulations, approves private accreditation organizations, monitors proficiently testing

• CDC: Analysis, research and technical assistance

What agencies must a lab be accredited by?

HCFA (CLIA or another recognized agency (CAP)

What is CAP?

• College of American Pathologists

• accreditation agency recognized by the federal government

• inspections occur every two years

• inspect blood bank as part of lab

What is the AABB?

• American association of blood banks

• blood bank accreditation agency

• inspection every 2 years

• only inspects blood banks

What is required by all accredication/inspection agencies?

• Compliance with federal regulations

What regulations does the FDA make for blood bank?

• collection and processing of blood for transfusion

• manufacture of reagents and controls

• blood is classified as a drug

What happens when deficiencies and/or non-compliance is detected during an inspection?

• organization may voluntarily correct the issue and document the correction

• organization may dispute the deficiency/non-compliance

• legal sanctions may result

What do GMPs ensure?

That regulated products are manufactured by controlled and auditable process

Where a GMPs that pertain to blood centers found?

Title 21 of the code of federal regulations

What are the FDA intent of gmps?

• to provide consistency

• safe and effective products

What is covered in a GMP manufacturing system?

• suppliers of equipment, reagent, ect

• testing personnel and other individuals involved in the process

• procedures to generate product

• the product itself

• storage, distribution and customer use of the product

If an SOP is changed what must happen?

• date of and reason for change must be documented

• documentation that all staff using the process are informed and trained in the new procedure

• retention to the old procedure for a designated period of time

What does quality management encompass?

• quality system

• quality assurance

• quality control

What must be included in a fatal transfusion reaction report?

• date of transfusion

• date of death

• type of product, unit number, collecting facility

• cause of death