Quality Assurance

degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge

quality

anticipated benefits or results from a planned implementation of a process

outcomes

NAM

National Academy of Medicine

the NAM broadly defines ____ as safe, effective, patient-centered, timely, efficient, and equitable

healthcare quality

3 ways to maintain quality

inspection

education and training of employees

PDCA/PDSA (plan-do-check/study-act)

ways to maintain quality: strategic model used to improve long-lasting, effective change

PDCA/PDSA (plan-do-check/study-act)

explain the steps of PDCA

Plan: team agrees on a project and an intervention if change is needed

Do: carry out the change in a small scale study

Check/Study: monitor change and analyze data for success/failure; what should be done differently for next cycle

Act: activate the changes

MDH

Minnesota Department of Health. e.g. MDH can inspect radiation-producing products at any time to make sure they are safely operating

agencies that establish rules (mandates) that must be followed about the use of radiation

regulatory agencies

mandatory requirements that can apply to businesses, individuals, governments, non profits, etc. about radiation use. mandates.

regulations (set by regulatory agencies)

regulatory agencies can be at what levels of authority?

federal, state, professional, or accreditation bodies

list of 5 federal regulatory agencies for radiation

NRC, EPA, DOT, OSHA, FDA

federal regulatory agency that ensures the safe use of radioactive materials (not linacs or x-ray equipment) while protecting people and the environment. e.g. nuclear power plants, research reactors, medical use (Co-60 machine, brachytherapy sources), industrial and academic use

NRC - Nuclear Regulatory Agency, est. 1974

NRC

Nuclear Regulatory Agency - use of radioactive materials

the NRC is regulated using the Code of ___

Federal Regulations

the Code of Federal Regulations given by the NRC includes:

dose limits to workers and public, exposure limits, monitoring and labeling of radioactive material, signage, reporting theft or loss, establishing penalties of concompliance

federal regulatory agency that provides dose limits to workers and public, exposure limits, monitoring and labeling of radioactive material, signage, reporting theft or loss, establishing penalties of noncompliance

NRC (Nuclear Regulatory Agency)

federal regulatory agency that assists the NRC in order to protect the environment. this includes storage, handling, and disposal of radioactive materials, and radon monitoring

EPA

federal regulatory agency that manages the safe transportation of radioactive materials

DOT

federal regulatory agency that regulates manufacturing and use of radioisotopes, protects public from unnecessary exposure from radiation-emitting electrical products, keeps record of quality testing and communication with vendors and maintenance companies, and requires reporting any safety issues (injury/death) right away or facing severe penalties

FDA - Center for Devices and Radiological Health

what is the name of the radiation regulatory agency within the FDA?

Center for Devices of Radiological Health

federal regulatory agency concerned with the safety of workers/employees. makes sure proper training and education is offered.

OSHA (1970)

devices regulated by the FDA’s Center for Devices of Radiological Health

general radiography, CT/MRI/US, linacs, low-level laser therapy, baggage x-rays, suntan parlors, video monitors, microwave ovens

state regulatory agency in MN

MDH - Minnesota Department of Health

there are how many NRC agreement states?

39

states to which the NRC relinquishes portions of its regulatory authority

agreement states - 39, including Minnesota

example of an institutional regulatory agency

The Joint Commission (TJC)

TJC

The Joint Commission - an institutional regulatory agency

agency that accredits and certifies healthcare organizations (not just hospitals) to assure best practices are being maintained. orgs may not receive reimbursement from Medicare/Medicaid or other insurance agencies if not accredited by them

TJC - The Joint commission - an institutional regulatory agency

3 professional regulatory organizations

AAPM, ASRT, ASTRO

professional regulatory organization that advises on standards for QA programs for treatment planning and delivery. develops task groups - most current is TG 142

AAPM - American Association of Physicists in Medicine

the most current task group developed by the AAPM

TG 142

professional regulatory agency that provides standards for clinical performance, quality performance, and professional performance for radiation therapists

ASRT

professional regulatory organization that is mostly for radiation oncologists, but also physicists and therapists. highly involved with continuing education and practice for accreditation maintenance. is the accrediting agency for APEx, which accredits radiation therapy clinics

ASTRO (American Society for Radiation Oncology)

ASTRO is the accrediting agency for ___

APEx - Accreditation Program for Excellence

the agency that accredits radiation therapy clinics

APEx, which is managed by ASTRO

examples of things that must be documented

quality of facility (shielding, patient dose monitoring, dose verification)

the radiation oncology program (accreditation, calibration, quarterly maintenance)

radiation safety (radioactive sources, personnel monitoring)

management of errors (events e.g. wrong patient/site/energy, over 20% dose from prescription)

near miss and good catch

monthly department review of M&M, mistakes done

updated credentials and licenses checked yearly by supervisor

equipment yearly and quarterly maintenance

safety recommendations for quality of facility include:

shielding, patient dose monitoring, dose verification

a medical error includes the wrong ___, wrong ___, or wrong ___ and over ___% dose from prescription

wrong patient, wrong site, wrong energy, over 20% dose from prescription

the supervisor needs to check updated credentials and licenses for the clinic’s staff how often?

yearly

the best practice is to have how many therapists per machine?

2 therapists

if 3 therapists work on a machine, what are the roles of each?

one to run the machine, one to monitor the patient, one to make sure that documentation and billing is done

the best practices for numbers of physics staff depends on:

number of units (machines), number of procedures (HDR, SRT, etc), number of patients per year

who is responsible for the establishment and continuation of a Quality Improvement (QI) program at a clinic?

medical director of the department (often one of the doctors)

responsibilities of a clinic’s medical director

establishment and continuation of a QI program

checking that all staff is up to date with licenses and/or certification

members of the QI team

medical director of department, radiation oncologist, physics/dosimetry, radiation therapists, nurses

member of the QI team responsible for conducting chart reviews, morbidity and mortality conferences, port film review, patient education, reviewing incident reports

radiation oncologist

member of the QI team responsible for carrying out their own QI program for equipment and treatment planning computers, as well as weekly and final review of treatment records

physics/dosimetry

member of the QI team responsible for daily warm-up and QC checks, verifying signed prescription and consent forms, documentation of treatment, and patient assessment and education

radiation therapists

member of the QI team responsible for patient assessment and education, ordering and evaluating blood tests, regular weight checks of patients

nurses

devices needed in a clinic for QA

ion chambers, TLDs, diodes

examples of things included in daily QA

things that could seriously affect patient positioning and dose distribution: ODI, lasers, daily output “checkers”, door interlock, audio and visual monitoring

examples of things included in monthly QA

less impact on dose distribution, or less likely to change throughout the month: flatness and symmetry, field/light coincidence, treatment couch indicators

QA checks of the block/mold room

monthly check of equipment, yearly air quality checks following OSHA guidelines

QA checks of accessory devices

latching integrity of electron cones, wedges, trays, and compensators

integrity of breast boards and head holders

a record that includes patient identification, consultation notes, medical records, treatment plan, and treatment devices

patient treatment chart

a patient’s daily record should include:

date, time out, daily and cumulative doses, number of fractions and elapsed days, treatment aids, imaging

when should QA of patient charts be done?

before the first treatment, and then weekly by therapists and physicists

for linacs and simulators, ____ QA recommendations have been used since 2009

AAPM TG-142. before that it was TG-40

if a machine fails tolerance within a QA, who decides the response?

physicist

daily QA tolerance for linacs X-ray and electron output constancy (all energies), (if not equipped with electron beam, then weekly electrons)

3%

daily QA tolerance for non-IMRT linacs laser localization, ODI at isocenter, and collimator size indicator

2 mm

daily QA tolerance for IMRT linacs laser localization, ODI at isocenter, and collimator size indicator

lasers 1.5 mm, ODI and collimator 2 mm

daily QA tolerance for SRS/SBRT machine laser localization, ODI at isocenter, and collimator size indicator

laser and collimator: 1 mm

ODI: 2 mm

daily QA tolerance for door interlock, door closing, AV monitors, beam on indicator, radiation area monitors (if used), and stereotactic interlocks (if used)

functional

monthly QA tolerance for x-ray and electron output constancy, backup monitor chamber constancy, typical dose rate output constancy, and electron beam energy constancy

2% (2% or 2 mm for electron beam energy constancy)

monthly QA tolerance for photon and electron beam profile constancy (flatness and symmetry)

1%

monthly QA tolerance for light/radiation field coincidence

2mm or 1% on a side

monthly QA tolerance for light/radiation field coincidence (asymmetric)

1mm or 1% on a side

monthly QA tolerance for distance check device for lasers, jaw position indicators (asymmetric), cross-hair centering, and compensator placement accuracy

1 mm

monthly QA tolerance for gantry/collimator angle indicators

1 degree

monthly QA tolerance for accessory trays (port film graticule), jaw position indicators (symmetric), and wedge placement accuracy

2 mm

monthly QA tolerance for treatment couch position indicators

2 mm/1 degree unless SRS/SBRT is used, then 1 mm/0.5 degree

monthly QA tolerance for latching of wedges and blocking trays

functional

monthly QA tolerance for localizing lasers

± 2 mm if non-IMRT, ± 1 mm if IMRT or SRS/SBRT

monthly QA tolerance for beam output constancy with respiratory gating

2%

monthly QA tolerance for respiratory gating: phase, amplitude, beam control; in-room respiratory monitoring system; gating interlock

functional

weekly test that checks that positional leaf precision of MLCs

picket fence test

who performs QA tests for brachytherapy?

physicists

how often does the physicist complete leak tests of brachytherapy sources?

every 6 months

when new brachytherapy sources are delivered, the activity must be within ___% of the vendor’s specifications, checked in a ___

3%; well ionization chamber

QA of brachytherapy sources includes accurate counting of sources, their activity, and identification method. what are examples of types of identification?

color, code, length

a full calibration on each linac must be done how often? beam data is measured in a ___

once per year; water tank

overall dosimetric accuracy must be within ___% of the treatment prescription. what accounts for this variation?

± 5%

calibration of ion chamber; the calibration procedure; dose calculations (e.g. rounding up vs. down), daily variations in treatment; reading and recording SSDs and other positioning variations

constancy of intensity over 80% of the field width

flatness

only 80% because of penumbra at the edges

how is flatness checked? how often?

with a beam profile. monthly, by physicist

what is the tolerance level for beam flatness?

TG-142 now lumps flatness and symmetry together into “beam profile constancy” with a tolerance of 1% for both x-rays and electrons

daily radiation output verification during QA must be within ___% of normal output. how is it measured?

± 3%; small dosimeters

monthly radiation output verification must be within ___% of normal output. how is it measured?

2%; thimble chamber in water phantom

test that makes sure the field light accurately represents the irradiated field

coincidence testing

two possible causes of failing a coincidence test

mirror misalignment after a field light bulb is changed in the gantry head (mirror gets bumped)

gantry head collision

old method for coincidence testing

mark a field size on a film and make an exposure. dark square where exposed should be within 2 mm of marked edges (or 1% on each side)

newer method of coincidence testing

light-field coincidence

(blue and red boxes on PP slide)

the digital collimator and gantry angle readouts should be accurate to within ___ degree of actual. how often is this checked?

1 degree. monthly check by physicist. used to be checked with a bubble/spirit level (old?)

how is a mechanical isocenter check done?

to check the intersection of axes of rotation of collimator and gantry, graph paper and center finder/wiggler are used to see if isocenter stays within a 2mm diameter circle as the gantry is rotated.

what is one reason the mechanical isocenter could fail a tolerance check?

the heavy weight of the gantry frame could flex during rotation

term for the actual treatment isocenter (as compared to the isocenter that the gantry and collimator actually rotate around)

radiation isocenter

how is the radiation isocenter checked?

star pattern test. collimators are set to make a thin slit of a field; it is rotated several degrees and an exposure is made. intersection of lines should be within a 2mm diameter circle or the isocenter fails tolerance check.

three types of rotation checks

mechanical isocenter

radiation isocenter (star field test)

split-field test (Winston Lutz)

QA used to check for symmetry when doing parallel opposed fields

split-field (Winston Lutz) test