Safety In IHBB Flashcards
1
Q
U.S. agency responsible for the regulation of the blood bank industry and other manufacturers of products consumed by humans
A
FOOD AND DRUG ADMINISTRATION
2
Q
Classifies blood as a drug
Requires all blood banks and transfusion services to follow its legally required standards
A
FOOD AND DRUG ADMINISTRATION
3
Q
Describes standards for quality and safety for transfusion services and blood banks through QA Programs (Quality Assurance programs)
A
FDA
4
Q
BLOOD BANK
Function →
A
collects, processes, stores, and transports human blood intended for transfusion
5
Q
• performs testing and issues blood and blood components for transfusion
A
TRANSFUSION SERVICE
6
Q
- enforces regulations to ensure the safety and efficacy of biologics, drugs, and devices, including blood and blood components and diagnostic reagents used or manufactured by blood establishments
A
Food and Drug Administration
7
Q
- publication from the Food and Drug
Administration outlining the legal requirements of blood banking facilities
A
Code of Federal Regulations
8
Q
- regulates all laboratory testing (except research) performed on humans in the United States.
A
Centers for Medicare and Medicaid Services
9
Q
- act to ensure that laboratory tests are consistently reliable and of high quality
A
Clinical Laboratory Improvement Amendments (CLIA)
10
Q
(CLIA)
A
Clinical Laboratory Improvement Amendments
11
Q
, is a voluntary accrediting agency.
A
American Association of Blood Banks
12
Q
- the goal of the society is to improve the safety of blood transfusion worldwide
A
International Society of Blood Transfusion
13
Q
- agency responsible for ensuring safe and healthful working conditions
A
Occupational Safety and Health Administration
14
Q
- act is enforced by the Occupational Safety and Health Administration (OSHA)
A
Occupational Safety and Health Act
15
Q
- determine types, numbers, and sizes of generators of medical waste in the United States
A
Environmental Protection Agency
16
Q
- comprises the combined activities performed by an organization to ensure the quality of products and services they offer, which must include good manufacturing practices (cGMPs)
A
Quality Assurance
17
Q
- performed in blood banks and
transfusion services as part of QA and are legal requirements established by the FDA.
A
Good Manufacturing Practices
18
Q
- plan for the management of all documents in an organization that addresses the design, responsibility, storage, removal, and revision of all records, forms, and procedure~
A
Document Control
19
Q
- written procedures to ensure the complete understanding of a process and to achieve consistency in performance from one individual to another
A
Standard Operating Procedures (SOPs)
20
Q
- If it was not recorded, it never happened. The concept seems simple; however, poor record keeping is the most common violation identified by regulatory and accreditation
A
Record Keeping
21
Q
- describe how a particular task is to be accomplished. Established methods for performing and administering processes ensure the consistent quality of the final product or result.
Internal and external auditors carefully assess noncompliance with written SOPs, one of the most serious violations that can be identified during an inspection.
A
Standard Operating Procedures
22
Q
- CDC term defining policies of treating all body substances as potentially infectious and applying safety measures to reduce possible exposure.
It incorporates universal precautions and body substance isolation
A
Standard Precautions
23
Q
- OSHA term defining policies of treating all body substances as potentially infectious and applying safety measures to reduce possible exposure
A
Universal Precautions
24
Q
- Blood bank safety programs must include policies for handling all waste materials from areas where waste is contaminated with blood or body fluids.
Medical waste
A
Biohazardous Wastes
25
- All laboratory surfaces and reusable equipment should routinely be cleaned and decontaminated daily and as needed while performing tasks and as spills occur.
Decontamination
26
- In the event an employee or other person is injured or possible injury or infection exists, an accident report should be initiated.
Worker's compensation, OSHA, and other regulatory and accrediting bodies require these reports.
Personal Injury and Reporting
27
CGMPs
Current good manufacturing practices
(CGMPs)
28
REGULATORY AND ACCREDITING AGENCIES FOR QUALITY AND SAFETY
Compliance with the standards set by the gov't agencies, such as_____,_______, and state agencies is enforceable by law
FDA
Centers of Medicare and Medicaid Services (CMS)
29
enforces regulations to ensure the safety and efficacy of biologics, drugs, and devices, including blood and blood components and diagnostic reagents used or manufactured by blood [components] establishments
Falls under the jurisdiction of the…
FDA
Department of Health and Human Services
30
Many industries fall under the jurisdiction of the FDA Including (4)
drugs, cosmetics, food and blood
31
FDA
Agency is involved in 3 Areas
1. Surveillance of facilities (inspections)
2. Policy enforcement
3. Establishment and issue of regulations
32
The FDA publishes its legal requirements in a book which is called the…
A publication from the FDÄ outlining the legal requirements of blood banking facilities
CODE OF FEDERAL REGULATIONS
33
Federal
agency with a lot of administrative
responsibilities, such as:
• - regulates all laboratory testing (except research) performed on humans in the United States.
Medicare
Medicaid
HIPAA (Health Insurance Portability and
Accountability Act of 1996)
Clinical Laboratory Improvement Amendments
34
• Regulations for accurate and reliable laboratory tests in the code of federal regulations
• act to ensure that laboratory tests are consistently reliable and of high quality
• Conducts routine inspections, and may impose sanctions to laboratories not meeting requirements
• Applies to physician's office, laboratories and hospital laboratories - areas in the hospital such as the Operating room and Emergency room and Independent Testing Laboratories
Clinical
Laboratory
Improvement
Amendments
35
______, is a voluntary ***accrediting agency.***
• Its publication serves as a guideline for members seeking accreditation
This includes the standards for blood banks and transfusion services, technical, manual, and others
American Association of Blood Banks
36
• the goal of the society is to ***improve the safety of blood transfusion worldwide***
• NOT A REGULATORY OR ACCREDITING
AGENCY
International Society of Blood Transfusion
37
• Responsible for providing a global standard or worldwide terminology, identification and labeling of medical products of human origin
• Can be of blood, cell, tissue and organ products, etc.
International Society of Blood Transfusion
38
agency responsible for ensuring safe and healthful working conditions
OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION
39
• act is enforced by the Occupational Safety and Health Administration (OSHA)
• Goal: Assure safe and healthful working conditions for working men and women by authorizing enforcement of standards developed under the act
Responsible for assisting and encouraging the states in their efforts to
assure safe and healthy working
conditions providing research, information education and training in the field of occupational safety and health and for other purposes
OCCUPATIONAL SAFETY AND HEALTH ACT
40
• determine types, numbers, and sizes of generators of medical waste in the United States
• Examines present/potential threat of medical waste to human health in the environment
ENVIRONMENTAL PROTECTION AGENCY
41
• comprises the combined activities performed by an organization to ensure the quality of products and services they offer, which must include good
manufacturing practices (cGMPs) (current good manufacturing practices)
• Part of the organization's goal to maintain an atmosphere of continuous quality improvement
QUALITY ASSURANCE
42
•______ is the responsibility of everyone in an organization/inside the blood bank laboratory
Therefore, internal quality audits evaluate the effectiveness of the QUALITY SYSTEM inside the laboratory / from another organization
Quality
43
Performed in blood banks and transfusion services as part of QA and are legal requirements established by the FDA.
• These regulations itemize what needs to be done without necessarily specifying HOW Each organization MUST DETERMINE THE BEST WAY to implement all good manufacturing processes
• They must have their own Standard Operating Procedures (SOPs); record and document all work performed;
GOOD MANUFACTURING PRACTICES
44
COMPONENTS OF A QUALITY ASSURANCE PROGRAM
1. Records and documents
2. Document control
3. Standard Operating Procedures
4. Record keeping
45
• According to the AABB Standards for Blood Banks and Transfusion Services, the facilities shall have policies, processes, and procedures to ensure document identification, review, approval and retention
These are created and stored in accordance with the RECORD RETENTION POLICIES
Examples include:
Manual
logs,
worksheets,
computer
printouts,
temperature charts, CD-ROMs, DVDs, and Photographs
Records and Documents
46
plan for the management of all documents in an organization that addresses the design, responsibility, storage, removal, and revision of all records, forms, and procedures
• Should specify and describe acceptable media to be used; types of documents to be kept, and record retention intervals
Document Control
47
• written procedures to ensure the complete understanding of a process and to achieve consistency in performance from one individual to another
• Therefore, every laboratory or organization should have a standard operating procedure in order for them to be uniform in everything they do.
Standard Operating Procedures (SOPs)
48
• If it was not recorded, it never happened. The concept seems simple; however, poor record keeping is the most common violation identified by regulatory and accrediting agencies
• Good documentation practices, whether manual or computerized, allow tracing of all products collected or transfused by an organization
Record keeping
49
A thorough record keeping system recreates every step related to the production and distribution of a unit of blood and all its components
It is very important in investigating errors and accidents
Audit Trail
50
is the most common violation identified by regulatory and accrediting agencies
Poor Record Keeping
51
Good Record Keeping
• Use of indelible (permanct) blue or black ink
• Blue ink is preferred
• Recording data on appropriate form or log
• Recording date and initials of person making a correction
• Recording data immediately after performance of task
• Not obliterating or deleting the original entry when making a correction
• Indicating "broken," "closed," or "not in use" when appropriate
• Not using "dittos"
52
Bad Record Keeping
• Use of correction fluid or white tape when making a correction
• Use of pencil or nonpermanent ink
• Recording data on a piece of scratch paper or sticky notes
• Not recording date or initials of person making a correction
• Recording data for someone cise
• Recording data later or not immediately after perfornance of task
• Obliterating or deleting original entry when making a correction
• Not recording "broken," "closed," or "not in use" when appropriate
• Use of "dittos"
53
NOT ACCEPTABLE ERROR CORRECTION
ACCEPTABLE ERROR CORRECTION
• Appears messy
• A record is corrected by placing a ***single line through the error,*** recording the correct information to the next error, and placing the initials of that person, making that correction along with the date (A statement describing the reason for correction is also recommended)
54
• describe how a particular task is to be accomplished. Established methods for performing and administering processes ensure the consistent quality of the final product or result.
• Internal and external auditors carefully assess noncompliance with written SOPs, one of the most serious violations that can be identified during an inspection.
STANDARD OPERATING PROCEDURES
55
Why is SOP very important?
These are very important training
tools for new employees because these documents should be written using a standard format
The_______ publishes guidelines for the development of SOPS
Clinical and Laboratory Standards Institute (CLSI)
56
• CDC term defining policies of treating all body substances as potentially infectious and applying safety measures to reduce possible exposure.
Standard precautions incorporate universal precautions and body substance isolation together.
• Minimum infection prevention practices that apply to all patient care regardless of suspected or confirmed infection status of the patient
STANDARD PRECAUTIONS
57
STANDARD PRECAUTIONS -Include
hand hygiene, use of personal protective equipment, sharp safety, respiratory hygiene/cough etiquette, safe injection
practices, sterile instruments and devices, etc.
58
OSHA term defining policies of treating all body substances as potentially infectious and applying safety measures to reduce possible exposure
• Involves precautions taken with all patients regardless of suspicion of infection to prevent the spread of blood-borne pathogens
• In an inevitable evolution, standard precautions in contrast, are steps taken to encompass fighting the spread of airborne pathogens in situations where providers come in contact with any form of body fluid
UNIVERSAL PRECAUTIONS
59
• All outerwear worn during the performance of blood banking tasks should be considered_____
• A______-resistant laboratory coat, gown, or apron whether disposable or made of cotton material is recommended
• Blood bank personnel should wear____ as a personal barrier when handling any blood or blood products, safety glasses, faceshields or masks, splash barriers and goggles are devices categorized as personal protective equipment
• _____should be worn when splashes are likely to occur during a task
contaminated
fluid
gloves
Safety glasses/goggles
60
• All outerwear worn during the performance of blood banking tasks should be considered_____
• A______-resistant laboratory coat, gown, or apron whether disposable or made of cotton material is recommended
• Blood bank personnel should wear____ as a personal barrier when handling any blood or blood products, safety glasses, faceshields or masks, splash barriers and goggles are devices categorized as personal protective equipment
• _____should be worn when splashes are likely to occur during a task
contaminated
fluid
gloves
Safety glasses/goggles
61
•_____ are better because they protect the mouth, the nose and the eyes
•_____are made of shatterproof plastic and wrapped around the face - offering greater protection
• Permanently mounted splash barriers over the bench area are preferred when task performance risk is splashing or aerosol contamination - the shield should be cleansed and decontaminated on a regular basis to avoid spreading of infection, if contaminated.
Masks
Face shields
62
_____should be capable of providing a gentle stream or spray of aerated water for an extended period
_____treat immediate first aid needs of personal contamination with hazardous materials and for extinguishing clothing fires
Eyewash device
Safety shower
63
Containment devices that facilitate safe handling of infectious materials and reduce the risk to personnel and the laboratory environment.
Procedures that expose open tubes of blood or units known to be positive for Hepatitis B surface antigen or Human
Immunodeficiency virus (HIV) are examples of blood bank procedures which it may be useful.
BIOLOGICAL SAFETY CABINETS
64
Biohazard waste
• Containers should be_____, and_____ are currently recommended for the disposal of blood samples and blood products
leak-proof
incineration, decontamination by autoclaving
65
OSHA also allows the use of EPA ( environmental protective agency ) registered disinfectants effective against HIV and Hepatitis B Virus
You can use diluted bleach solutions or combination of disinfectants for
decontamination of working area
A fresh solution of a_____ can be used for general disinfection or for spills
1:10 dilution of Sodium hypochlorite (bleach)
66
PERSONAL INJURY AND REPORTING
• In the event an employee or other person is injured or possible injury or infection exists, an accident report should be initiated.
An ______should be initiated in all accidents and injuries involving employees or other persons - routine investigation of a minor incident and follow-up to correct the risk may thwart a major accident later
accident report
