12. QC & orientation Flashcards
enforces the code of federal regulations and federally established laws
Food and Drug Administration (FDA)
performs lab-wide inspections to monitor compliance with quality performance standards
College of American Pathologists (CAP)
emphasis on standardization and quality of technical aspects of blood banking
Association for the Advancement of Blood and Biotherapies (AABB)
local professional organization with Mary as president
Heart of America Association of Blood Banks (HAABB)
sets guidelines and rules for use of irradiators
Nuclear Regulatory Commission (NRC)
emphasis on employee safety in the workplace
Occupational Safety and Health Administration (OSHA)
a process intended to ensure that reagents and equipment function as expected
quality control
a process intended to provide confidence that systems and elements that influence the quality of the product/service are working as expected
quality assurance
organizational structure, responsibilities, policies, procedures and resources established by executive management to achieve quality
quality systems
a process intended to ensure that problems with processes and procedures can be identified, monitored and corrected
quality improvement
certification of CLS professionals
American Society of Clinical Pathologists (ASCP)
accredits CLS programs
National Accreditation Agence of Clinical Laboratory Science (NAACLS)
internal assessments covering the quality system and major operating systems of blood services
audits
structured evaluation of laboratory methods that assesses the suitability of processes, procedures, equipment, materials, and personnel
proficiency
evaluation of the ability of the coworker to perform a specific task according to procedures
competency
step by step directions used by an individual to perform a specific task
SOP
documents the way the facility conforms to federal, state, and local regulations
policies
testing to ensure equipment and processes are functioning as expected, required before implementation and after modifications
validation
provides for immediate retrieval of information on a patient, blood product or donor
Lab Information System (LIS)
set of regulations, codes and guidelines for the manufacture of drug substances and medical devices, diagnostic products and foods
current good manufacturing processes (cGMP)
provides a worldwide standard to ID each blood component with a unique identifier
International Society of Blood Transfusion (ISBT)
provides evidence that regulations and standards are met and that all coworkers are following the same procedures and policies
document control
follow any unit of blood or component from its source to its final disposition
tracibility
used to prevent unauthorized persons from accessing information
password
alternative system to obtain previous record during downtime
backup
system performs an interpretation of results, prohibition of action, or provision of information that a tech uses to make decisions
critical point
critical point examples
- forward and reverse types do not match
- type does not match previous record
- product doesn’t meet pt special needs
- specimen or visit is not current
4 aspects of document control
- procedures and forms verified for adequacy, reviewed and approved, then kept current with regulations and standards
- versions are controlled and changes are identified
- documents are protected from alteration, or unintended use or destruction
- ensures all testing and processes are performed according to procedure the same way by each tech
good record keeping tips
- concurrent documentation of each step
- use non-water soluble pen
- write clearly and neatly
- proper method for making corrections
- enter enough details so document can be understood in the future
10 commandments of cGMP
- validation—design and construct facilities and equipment properly
- document control—write step by step operating procedures
- follow written procedures and instructions (no copies or cheat sheets)
- document work as performed
- validate work
- QC and PM—monitor facilities and equipment
- design, develop and maintain job confidence
- protect against contamination
- control components and product related processes
- conduct planned and periodic audits
emphasis on safety/risk management; scheduled inspections monitor compliance
the Joint Commission (TJC)
infectious disease reporting in the BB
state health department
type of irradiation now used
x-ray
unscheduled inspections
FDA
may have dual —–/—– inspections
AABB/CAP
scientific society which promotes science, research, and best practice in areas of transfusion medicine
ISBT
CLIA
clinical laboratory improvement amendmends (1988)
aims to improve the quality and safety of collecting, processing, testing, transfusion and distribution of blood products
voluntary and nongovernmental
accreditation
force of law; ensures safety for the blood supply, blood donors, and blood product recipients
mandatory and federal
regulations
CMS
center for medicare and medicaid services
10 quality systems essentials
- organization
- resources (personnel)
- equipment
- supplies/customer issues
- process control, final inspection, handling
- documents and records
- deviations, nonconformances, adverse events
- assessments
- process improvement
- facilities and safety
defines and documents the parties responsible for provision of blood, blood products, and services
organization
products used in the collection, testing, processing, holding and distribution of blood that have the potential to affect the quality of blood
critical materials
CAPA
corrective and preventive action
uses a collaborative team effort to improve performance by systematically removing operational waste and reducing process variation
lean six sigma
an action taken in response to identified problems
corrective action
active planning for potential problems
preventive action
documentation hierarchy
- policies (what to do)
- processes (how it happens)
- procedures (how to do it)
- forms, records, supporting docs, QC records, templates (tools to use)
unknown samples received from a designated provider, tested as other samples
demonstrates that a facility provides comparable results to other facilities
proficiency testing (PT)
direct observations of test performances, testing previously resulted speciments, and assessment of problem solving skills
competency assessment
6 elements required by competency assessment
- direct observation of test performance
- monitoring of recording and reporting results
- review of test results/worksheets/QC records
- direct observation of instrument maintenance and function checks
- testing previously resulted specimens
- assessment of problem solving skills
analysis of quality indicator data, complaint records, blood utilization
product audit
useful to maintain inspection readiness
self-audit
follow a product to the floor, observe the transfusion
process audit
5 functional areas of blood bank
- blood donor services (BDS)
- component processing and storage
- main BB lab
- reference lab
- component preparation and issue
5 basic BB bench assignments
- ordering
- crossmatch
- reference
- hot seat
- float
reviews all orders that print in the blood bank, receives specimen and performs computer steps necessary for testing
ordering tech
performs all routine pretransfusion testing
crossmatch tech
serological problem solver
reference tech
primary person assigned to preparation and issuing of blood products
hot seat tech
second issuing tech, may also help in any area
float tech
allows EXM
results and interpretations recorded
stand alone BBIS
methods preventing unauthorized access to a computer system
- passwords
- program restrictions
- terminal lockouts
necessary before a computer system is used or if a change is made (5)
- program development
- installation of system
- validation of functionality and date integrity
- training of personnel
- policies and procedures for system maintenance and operations
HIPAA
health insurance portability and accountability act
patient info kept so inadvertent —— does not occur
use or disclosure
basic tenet of cGMP
quality cannot be tested into a product, but must be built into each product during all stages of manufacturing process
access blood portion of code of federal regulations
title 21
chapter 1
subchapters F (biologics) and C (drugs)
subchapter F concerned with…
safety, purity and potency
subchapter C concerned with…
safety, purity and effectiveness
revalidation may be necessary when…
changes or process deviations occur
consequences of noncompliance
- FDA warning letter
- FDA licence suspension
- FDA licence revocation
- seizure
- injunction
- prosecution
