[22] CHAPTER IX LESSON 4 Flashcards
When discussing Quality Programs, it includes:
Quality Control
Quality Assurance
Quality Improvement
For Blood Banking Quality Programs are essential requirements of 2 Federal Agencies:
- Centers for Medicare and Medicaid Systems (CMS)
- Food and Drug Administration
formerly HCFA, under CLIA-88 which covers all Clinical Laboratory activities and related federal payments
- Centers for Medicare and Medicaid Systems (CMS)
- Food and Drug Administration that has the following concerns:
a. Responsibilities of the [?] (anticoagulants and preservatives, shelf life etc.)
b. Specific requirements related to independent [?] for overall quality of blood products and the processes related to dispersion of those products.
blood product requirements
quality control and quality assurance
A number of accrediting agents have quality requirements as well:
- American Association of Blood Banks (Blood Banks and Transfusion Services)
- Joint Commission on the Accreditation of Healthcare Organizations
- College of American Pathologists
SOP’s - Standard Operating Procedures
AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization
Training plans and development of procedures
AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization
Approval of lot release of reagents and quality control reagents
AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization
Review and approval of practices relating to personnel, equipment, selection of suppliers, process control, final inspection and handling nonconforming components, methods in place for handling incidents, errors, and accidents.
AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization
Methods for hiring of qualified personnel needs to be in place
Personnel Practices
Job descriptions for all positions need to exist and be available
Personnel Practices
Training program and full documentation of that training for new and continuous employees.
Personnel Practices
Whenever a new procedure or instrument is implemented a training program needs to be in place.
Personnel Practices
Regular competency evaluations including direct observation and documentation of such must occur.
Personnel Practices
Validation of new equipment
Equipment
Calibration and preventative maintenance including standard equipment like refrigerators, complex equipment and computer systems
Equipment
Continual monitoring of blood bank refrigerators extremely important in both blood centers and transfusion services
Equipment
According to AABB, the following criteria and documentation must be in place in the individual laboratory.
List of [?]
Clearly defined [?]
Evaluation of [?] to meet requirements
Included: requirements for [?] to notify facility of changes
Prior to use of [?] they need to be tested.
Determination needs to be made relating to whether they are satisfactory for [?]
Documentation of [?]
Documentation of [?] needs to done by facility before being put into use and prior to each use for reagents related to ABO, Rh, antibody screening and infectious diseases before being used for patient or donor testing. (See attached worksheet for daily QC of blood bank reagents.)
critical supplies and services
requirements
suppliers qualifications
manufacturer mechanisms
incoming supplies
intended use
package, storage and transportation
testing
Development of SOP
Process control, final inspection, and handling elements
Control of changes in policies, processes or procedures
Process control, final inspection, and handling elements
Acceptance testing to new/revised software involved in blood bank procedures
Process control, final inspection, and handling elements
Validation of new policies, processes or procedures
Process control, final inspection, and handling elements
Monitoring and control of production processes
Process control, final inspection, and handling elements
Participation in proficiency testing appropriate for each testing system in place
Process control, final inspection, and handling elements
Established QC procedures for supplies and equipment
Process control, final inspection, and handling elements
Supplier qualifications and product specification need to be in place
Process control, final inspection, and handling elements
Control processes for nonconforming blood and blood components and products.
Process control, final inspection, and handling elements
Documents and records have 4 levels
relate to “What to do” in response to various situations
- Policies (Level 1)
relate to “How it happens”
- Processes (Level 2)
“How to do it”
- Procedures (Level 3)
that need to be completed when you are performing the procedures and following the processes and policies.
- Forms/Records, Supporting Documents etc. (Level 4)
Process to capture incidents, errors etc.
Incidents, errors, and accidents
If incident occurs, the severity of the incident is determined by the facility
Incidents, errors, and accidents
: “What is the likelihood it will happen again?” and what to do about it if it could happen again
If it is a one-time incident
“What might be the root cause?”
If there are multiple similar incidents
Develop processes for continuous improvement to help eliminate both one-time incidents and multiple similar incidents.
Incidents, errors, and accidents
includes both internal and external assessment
Quality Assessment Program
includes blood usage review committees within a hospital (transfusion audits) or institutional QA teams
Internal assessment
include inspections, surveys, proficiency surveys performed by agencies like the FDA, AABB, and CAP
External assessments
Corrective actions that are educational not punitive
Process improvement
Timely corrections
Process improvement
Yearly reports relating to QA and CQI committees
Process improvement
Although both transfusion services and blood centers are primarily concern with safe transfusions and related issues, there also needs to be processes in place related to employee safety
Facilities and safety
Compliance with OSHA requirements: chemical and biologic
Facilities and safety
Disaster preparedness
Facilities and safety
Adequate space and ventilation
Facilities and safety
Adequate sanitation and water systems etc.
Facilities and safety
Evaluations of limitations of physical structure prior to implementation of new equipment or processes
Facilities and safety
An allogeneic blood donor should weigh at least
110 lbs (50 kg).
The minimum hemoglobin for a female whole blood donor is
12.5 g/dL.
The minimum hemoglobin for a male whole blood donor is
13.0 g/dL.
Persons who have had a blood transfusion are deferred for [?] owing to risk of exposure to hepatitis, HIV, or other viral diseases.
12 months
The interval between whole blood donations is [?].
8 weeks or 56 days
The interval between plasmapheresis, plateletpheresis, or leukapheresis is at least [?].
2 days
Attenuated live viral vaccines such as smallpox, measles, mumps, yellow fever, and influenza carry a [?] deferral.
2-week
A blood donor that has a positive serologic test for syphilis is deferred for [?].
12 months
refers to blood for the donor-patient that is drawn before an anticipated transfusion for surgery and stored until used.
Predeposit autologous donation
An autologous donor must have a hemoglobin of at least [?] and a hematocrit of at least [?].
11.0 g/dL
33%
A person who has received a nonhuman animal trans plant of cells or tissues is [?] deferred from donating whole blood.
permanently
Males who have had sex with another male (MSM) in the past 12 months are deferred for [?].
1 year
Acute normovolemic hemodilution takes place in the operating room when [?] of whole blood are collected and the patient’s volume is replaced with colloid or crystalloid, then reinfused during surgical procedure, starting with the first unit collected.
1 to 3 units
can be a powerful tool for a Blood Service if it is planned and implemented appropriately as a whole-of-business program that adds value to the entire Blood Service beyond meeting compliance
quality assurance program
can ensure consistency of product, reliable results, effective risk-based decision-making and reduction in wastage through minimization of errors
quality assurance
therefore provides a strong basis for donor, product and staff safety.
Quality assurance
