PMLS2_LEC13 Flashcards
It can be defined as accuracy, reliability, and timeliness of reported test results
LABORATORY QUALITY
● Involves procedures to ensure that acceptable standards are being met while the procedures are being performed
● Employs the use of standards, calibrators, and controls
→ ____ are used to adjust customer system to
an established reference system or method
→ ____ are verifiers on the recovery of levels of
the standardized ranges of reagents and calibrators
→ Both ____ are used to ensure
reliability and consistency of the assay results
→ ____ are materials containing precisely known
concentration of the substance being analyzed
QUALITY CONTROL; Calibrators; Controls; calibrators and controls; Standards
● Set of activities to ensure confidence that quality
requirements will be fulfilled
● Addresses procedures in all phases of the laboratory process, which includes QC (Quality Control)
QUALITY ASSURANCE
A systematic and independent examination to determine the degree of conformity to predetermined standards and criteria are exemplified
QUALITY ASSESSMENT
● Focuses specifically on the testing process, or analytical phase of the lab process
● Limited to a test or procedure
QUALITY CONTROL
● Encompasses everything (all phases of the lab process)
● ”Big picture”
QUALITY ASSURANCE
● Voluntary, non-governmental agency
● Establish standards for the operation of hospitals and other-health related facilities and services
● Goals:
◆ To continuously improve healthcare by evaluating
institutions or organizations
◆ Inspire said institutions to excel in providing safe and effective care of the highest value and quality
JOINT COMMISSION INTERNATIONAL (JCI)
● Global, non-profit standards developing organization with representatives from the profession, industry, and government
● Goals:
◆ Develop best practices in clinical and laboratory
testing and promote their use throughout the world
◆ Use a process that balances the viewpoints of the
industry, government, and the healthcare professions
CLINICAL AND LABORATORY STANDARDS INSTITUTE (CLSI)
● International standard-setting body composed of
representatives from various national standards
organizations
● Goal: Develop worldwide standardization by promoting adoption of international quality standards
● ____ – provides guidance for quality in service industries
● – requirements for quality and
competence in Medical Laboratories
INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION (ISO); ISO 9001; ISO 15189:2007
● State policies and procedures that apply to each test or practice performed
PROCEDURE MANUALS
◆ Notify changes
◆ Make annual reviews
Responsibilities of supervisor
◆ Read and familiarize the procedures that are in
the manuals
Responsibilities of staff
The procedure manual indicates:
◆ Principle and Purpose of the test
◆ Sample Type and Method of Collection
◆ Equipment & Supplies Needed
◆ Standards & Controls
Forms used to record equipment checks used in the laboratory
◆ Verification of new lot numbers (tube additives,
vacuum strength, and expiration dates)
◆ Refrigerator and freezer temperatures (should be
recorded)
◆ Centrifuge maintenance checklist
EQUIPMENT CHECK FORMS
Instances where ____ is given
◆ Injury that occurs during the performance of the
procedure (needlestick injury, slipping on wet floor, back injury)
◆ Errors in labeling and processing of samples
◆ Insubordination and other misdemeanors
Confidential incident reports (IR)
(IR must state facts, not feelings)
Most important things in the IR:
◆ Identification of the problem
◆ Statement of the consequences of what really
happened
◆ Description of the corrective actions that has
been done
● Anything that can be changed or altered
● Identification provides basis for development of
procedures and policies
VARIABLES
◆ ____ - variables that occur
before testing
◆ ____ - variables during the
testing process
◆ ____ - during the
reporting and interpretation of results of the
procedures you have done
Pre-examination variables; Examination variables; Post examination variables
what variable?
Patient client prep and sample collection
Personnel competency test evaluation
Sample receipt and accessioning
Sample transport
Pre- Examination
what variable?
Quality control testing
Examination
what variable?
Reporting
Record keeping
Post-Examination
Information required on laboratory requisitions:
- Patient’s first and last name, gender, DOB
(Date of Birth) - Name of doctor requesting the test
- Name of person to contact with critical results
- Name of test(s) ordered and special handling
requirements - Date and time of collection and arrival in the
laboratory
How do we identify patients?
◆ Patients must be actively involved in the ID process
◆ There should be at least 2 patient identifiers
◆ CLSI recommends having the patient spell out their last name
◆ Match these against the laboratory requisition form
◆ Proceed to check the ID band or bracelet
➔ Misidentification can be grounds for SUSPENSION
OR DISMISSAL of the person responsible
➔ On the worst case scenario, it can be used as grounds for malpractice lawsuits
- comparison between a patient’s previous
test results and the current results
Delta Check
● Ensure sterility and quality of needles and puncture
devices
● Ensure stability of evacuated tubes and their additives
● Ensure safety of the phlebotomist and patient with the use of appropriate disposal containers and safety
devices
PHLEBOTOMY EQUIPMENT
● When tourniquet is applied for more than a minute, the concentrations of the following will increase:
◆ Bilirubin
◆ Lipids
◆ Proteins
◆ Enzymes
◆ Hemolysis increase K+
Areas to avoid because of possibility of contamination:
◆ Hematoma
◆ Edematous Areas
◆ Arms adjacent to mastectomies
◆ Arms receiving intravenous fluids
Areas to avoid to prevent injury to the patient:
◆ Burned or scarred areas
◆ Arms adjacent to mastectomies
◆ Arms with fistulas and shunts
◆ The back of the heel
◆ Previous dermal puncture sites
◆ Arteries (for routine testing)
Ideal protocol for needle stick injuries is as follows:
◆ Report to the supervisor, who then allows the
employees that has been injured, paged for;
◆ Employee counseling
◆ Immediate testing
- Especially on infectious diseases; HIV,
hepatitis
◆ Follow-up testing 3-6 months after
Quality of written reports can be severely affected by:
- Delay in the delivery of results
- Failure to place the reports in the correct location
- Errors in the transfer of written reports to the
computer
● Only used to report STAT results and critical or panic values
● When reporting these values verbally, it is crucial that the receiver repeat the information back to the caller
● Ideally, both parties should document the interactionincluding:
- Patient involved (name of the patient & date of birth)
- Reported test value
- Names of the caller and the receiver
- Date and time of interaction
TELEPHONE OR VERBAL RESULTS
● Incorporated many of the objectives of TQM and CQI (Continuous Quality Improvement) to ensure staff
competence and efficiency is in place within the
organization
● ____ is defined as coordinated activates to direct and control an organization with regard to quality and the reduction of medical errors
Quality Management System
There are 12 fundamental components called QSEs
(Quality System Essentials):
- Organization
- Facilities & Safety
- Personnel
- Equipment
- Purchasing and Inventory
- Process Control
- Documents and Records
- Information Management
- Occurrence Management
- Assessments
- Customer Service
- Process Improvement
Originated in Japan (first initiated by Toyota)
● “Do more with less”
● Ability to decrease costs while providing quality
healthcare
● Utilizes a tool called “5S”: enumerate
Lean System; Sort, Straighten, Scrub, Safety, Standardize, and Sustain
developed by Deming
Plan-Do-Check-Act Cycle
● “Plan-Do-Check-Act” modification
● Primary goal: reduce variables and decrease errors to a level of 3.4 defects per 1 million opportunities.
● ____ technology utilizes DMAIC:
Six Sigma; Define, Measure, Analyze, Improve, Control
