chief diagnostic medical physicist inspector university of

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1

Steven J. Backes President and CEO Atirix Medical Systems

Angela Snyder, Ph.D. Director, Research Atirix Medical Systems

Allen Goode, M.S., DABR Chief Diagnostic Medical Physicist

Department of Radiology & Medical Imaging

University of Virginia Health System

QC Zen and the Art of Inspector Happiness

April 27, 2016

Steven J. Backes, President and CEO, Atirix Angela Snyder, Director, Research, Atirix Allen Goode, Lead Diagnostic Medical Physicist, UVA

QC Zen DISCLOSURES

CONTRIBUTORS Andrea Browne, Medical Physicist, Dept. of Engineering, TJC

Marion Boston, Assistant Director, ACR

Eric Berns, Chair ACR Mammography Committee, Assistant Professor and Diagnostic Medical Physicist, Denver Health, UC Denver

April 27, 2016 Copyright (c) 2016 Atirix Medical Systems, Inc. 2

Steven J. Backes President and CEO Atirix Medical Systems

Angela Snyder, Ph.D. Director, Research Atirix Medical Systems

Atirix sells the QC-Track® system for enterprise QC

Allen Goode, M.S., DABR Chief Diagnostic Medical Physicist

Department of Radiology & Medical Imaging University of Virginia Health System

- Atirix client, informal advisor - Member, Global Advisory

Board, Radimetrics/Bayer - Member, AAPM TG 272 - Inspector, State of Virginia


QC Zen Learning Objectives


• The latest device QC regulations, including from TJC and ACR

• Features of enterprise QC systems

• Features of cost justification tools, including the SBAR

• Recent inspection priorities and areas of interest

• Upcoming regulations and areas of QC concern

Dose? CQC?

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QC Zen Agenda • QC Zen

– Inspection Cycle model

– Survey of recent QC regulations and trends

– Review today’s enterprise Quality Control model

– Quality control technologies and alternatives

• Inspector Happiness – Case studies

• What’s on the horizon – TJC Fluoroscopy, ACR Mammography



QC Zen

Dr. Stewart Bushong

Baylor Medical Center

“Medical Imaging: More Than Fifty Shades of Grey.”

AHRA Annual Conference

July 20, 2015

April 27, 2016 Copyright (c) 2016 Atirix Medical Systems, Inc.

“All the world now follows MQSA”

5


QC Zen Alright, what was the life like back when the early ‘90s as the Mammography Quality Standards Act (MQSA) was being introduced?


1992 was an election year!

George Bush Bill Clinton Ross Perot

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QC Zen Minneapolis’ own Prince was rocking the culture



QC Zen Yes, there were computers and cell phones…


IBM PS1

Windows 3.1

Motorola “bag phone”


QC Zen

There were early imaging systems, but it was 1994 before the first 2 slice CTs hit the market


Elscint 2 slice CT

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QC Zen

And in 1994 inspectors were getting ready for MQSA



QC Zen HCFA (now CMS) had a challenge… figure out how to do an annual inspection of 11,000 MQSA facilities

• Medicare had been inspecting Mammo screening facilities

• OIG gathered data, including 87 interviews with facilities, on – # of Medicare certified facilities

– Length of time and cost of on-site inspections

– Inspector training

– Inspection results


6,800 Mammo Screening facilities under quality regs

11,000 Mammo Screening and

Diagnostic facilities under MQSA quality

regs and needing an

annual survey

Medicare

MQSA


QC Zen


State inspectors say that facilities’ unfamiliarity with regulations is the biggest problem encountered during inspections.

It is possible that many of these procedures are being performed, but are not properly documented...

Nevertheless, documentation of such activities are often the only way that inspectors have of determining the presence of quality assurance activities.

What did HCFA find out about inspections?

“45 of 87 facilities had

no knowledge of the

regulations”

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QC Zen … and more…

The facilities’ initial unfamiliarity with [Medicare] requirements contributed to unnecessary noncompliance by the facilities.

This in turn required that the State inspectors spend additional time and effort filling out paper work and conducting follow-up visits.

Furthermore, a lack of documentation of QA process measurements prevents trend analysis which is essential to a QA program.


“86% of inspected

facilities had at least one

failure”


QC Zen … so back to now, 2016

• Regulation Compliance Cycle

– Knowledge -> Performance -> Documentation

• Why are we here today?

– Lots of new regulations, and inspectors are facing a lot of new requirements – it’s 1994 all over again!

– The challenge:

• Then – how to implement broad inspections for 1 modality

• Now – 4 modalities, and soon 5

– Any reason to believe it will be easier?

• Maybe…


Compliance Cycle

13,000 units

30,000+ CT MR PET

Nuc Med

MQSA

TJC


QC Zen


MQSA QC

Service reports Radiologist

credentials

Sign-offs Technologist credentials

Physicist reports

Failure Tracking

MRI QC

???

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QC Zen


Compliance Cycle


QC Zen


“All the world now follows MQSA”


QC Zen


Device Quality Control

Credentials

Inspections

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QC Zen The Joint Commission and diagnostic imaging QC

TJC “Diagnostic Imaging Requirements”

August 10, 2015



QC Zen TJC Diagnostic Imaging Requirements: Impact on day-to-day QC • Per TJC briefing, the facility is responsible for identifying the

appropriate QC for CT, MRI, PET, and Nuc Med systems, and the facility needs to prove it is following its QC plans

• Per Dr. Browne:

– Plan: “The organization identifies QC and activities to maintain the quality…”

• Equipment and activities

– Includes any CT system with billing for diagnostic imaging

• Frequency and by whom

– Prove: “The organization maintains the quality…”

• TJC review: Observation? Logs?

April 27, 2016

Dr. Andrea Browne, TJC AHRA Annual Meeting,

Jul 21-24, Las Vegas

Copyright (c) 2016 Atirix Medical Systems, Inc. 20


QC Zen Diagnostic Imaging Requirements & technologists


MRI safety risks

Quarterly dosimetry review

Quality Control CT Annual Dose Analysis and

Physics

MR Annual Physics Nuc Med

Annual Physics

PET Annual Physics

Construction shielding

CT Physicist Credentials

CT Technologist Credentials

MR Technologist Credentials

CT Dose Tracking by Exam

Correct Patient

Protocols

CT dose incidents

MRI injury data

Inspector

happiness hint: So far the most common issu es seen by TJC are in MRI Safety

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QC Zen


TJC Diagnostic Imaging

Requirements

Prove it. Plan it.

“The organization maintains the quality of the... images produced.”

TJC review: Observation

Logs

“The organization identifies quality control and maintenance activities”

for CT, PET, MRI, and NucMed.

Equipment and activities Frequency and by whom

Dr. Andrea Browne, TJC AHRA Annual Meeting, Jul 21-24, Las Vegas


QC Zen Device Quality Control

• Printers and Monitors • Visual Checklist • Mechanical • Image Uniformity and

Artifacts • Geometric Accuracy • Resolution • Sensitivity/SNR • Scaling • Dose

Inspector happiness hint: The

physicist annu al inspection is requ ired every year on every device



QC Zen American College of Radiology accreditation

• 38,000 facilities accredited since 1987, per ACR

• Wide variety of accreditation options – New compliance requirements, e.g. BICOE

– New web site: http://www.acraccreditation.org/


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QC Zen

Continuous Quality Control A continuous quality control (QC) program must be established for all CT units with the assistance of a qualified medical physicist. An on-site radiological technologist should be identified to be responsible for conducting routine quality control. The continuous QC program must include, but not be limited to, the following: • Water CT Number & Standard Deviation- Daily • Artifact Evaluation- Daily • Wet Laser Printer Quality Control- Weekly (if applicable) • Visual Checklist- Monthly • Dry Laser Printer Quality Control- Monthly (if applicable) • Display Monitor Quality Control- Monthly

CT Accreditation Program Requirements

ACR Accreditation and Quality Control

25 April 27, 2016 Copyright (c) 2016 Atirix Medical Systems, Inc.

• Continuous Quality Control program – Details are found in the modality

Accreditation Program Requirements document

• Includes: – Quality Control

– Personnel Qualifications

– Preventive Maintenance/Service requirements

Inspector Happiness

Hint: If you r CT, MR, PET and Nu c Med u nits are not ACR accredited th en you r TJC inspector wi ll be looking for you to follow th e QC defined by you r manu facturer


QC Zen ACR Accreditation – BICOE


1,034 995

2015 2016

Breast Imaging Center of Excellence

REQUIREMENTS SUMMARY

• Mammography by the ACR (or an FDA-approved state accrediting body)

• Stereotactic Breast Biopsy by the ACR

• Breast Ultrasound by the ACR (including the Ultrasound-Guided Breast Biopsy module), and

• New: Enhanced Breast MRI requirements, with higher minimum volumes

• Effective: January 1, 2016

• Centers may also satisfy this requirement if they refer their patients to another facility for breast MRI and breast MR-guided biopsy outside their center.

• This facility must be accredited by the ACR in Breast MRI and may be within their facility system or in a referral relationship with the

Center of Excellence.


QC Zen ACR Accreditation – DICOE

27 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 2016

34

174

2015 2016

Diagnostic Imaging Center of

Excellence

REQUIREMENTS SUMMARY

• ACR accreditation in all modalities provided where ACR accreditation is offered

• Dose Index Registry® (DIR) and General Radiology Improvement Database (GRID) participation

• Image Gently® and Image Wisely® pledges

• Site survey assessing multiple areas of quality, safety, procedures and personnel by an ACR survey team that includes a radiologist, medical physicist and technologist working with your team members

• 21 facilities in process

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QC Zen New: ACR – Basic vs. Advanced


10 Modality Accreditations

Breast Imaging Center of Excellence

Diagnostic Imaging Center of

Excellence


QC Zen

MIPPA – # of sites by CMS-accredited accreditors


May 2013, GAO Report MEDICARE IMAGING ACCREDITATION Establishing Minimum National Standards and an Oversight Framework Would Help Ensure Quality and Safety of Advanced Diagnostic Imaging Services


QC Zen Regulations


MQSA TJC

MIPPA

ACR

State

AIUM

IAC

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QC Zen


Credentials

Inspections



QC Zen Imaging credentials

• CME/CEU and Exams

• Required at the point of inspection

• Challenge: Clinical professionals work in multiple locations, and each location required to have a copy


Inspector Happiness Hint:

A common inspection issu e is physician and physicist credentials not on -site


QC Zen


Credentials

MQSA/ACR MG ACR CT and MR TJC/ARRT

Continuing Experience (exams/months)

200/24 CT – dose training MR – safety training

Continuing Education (CEU/months)

15/36 24/24 ARRT - 24/24 or NMTCB

Continuing Experience (exams/months)

960/24 General - 200 /36 Specific - 60 /36 Cardiac – 50/24

Continuing Education (hours CME/months)

15/36 General - 150/36 Specific - 15/36

Continuing Experience (surveys/months)

Facilities: 2/24 Units: 6/24

Units: 2/24 ABR - 1 PQI project/36

Continuing Education (CEU or CME/months)

15/36 15/36 ABR – 75/36

Ph

ysic

ist

Rad

iolo

gist

Te

chn

olo

gist

TJC: Advanced-level certification in CT required (effective Jan 1, 2018) – new 2/16/16

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QC Zen


Credentials

Inspections



QC Zen Inspections


MQSA TJC

MIPPA

ACR

State

1 year

3 year 18 – 36 month

depends

random


QC Zen


Inspection Stats • Annual inspection at all 8,740 certified facilities (April 1,

2016) • Plus: ACR inspections

• 50 random on-site inspections per year • Random off-site inspections of 3% of facilities, about

260/yr total

• 38,000 certified facilities, 995 BICOE, 174 DICOE • Approx. 6,500 MIPPA ADI (Advanced Diagnostic Imaging)

suppliers receive an ACR inspection every three years • MIPPA inspection teams will also review other ACR facilities

in the area

• TJC accredits approx. 88% of accredited US hospitals, including 4,000+ accredited hospitals and 361 critical access hospitals (per TJC web site)

• Imaging inspection statistics not yet available (only about 8 months into program)

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QC Zen TJC and Imaging Inspection • Today: observational, due to imaging skill levels of inspectors

– Plan to add more imaging skills as time goes on

• Professional latitude accepted, but need professional guideline

support

• Tracer method – TJC uses three types of tracers:

• Program-specific tracers, which identify safety concerns within different levels and types of care, treatment, or services;

• Individual tracers, which “trace” the care, treatment, or services received by individual patients; and

• System tracers, which explore one specific system or process across the organization.



QC Zen Dr. Browne’s best advice on how to survive your inspection?

“If you say it, you’d better do it!”

Examples: • If your policy is for a daily QC test,

– be prepared to actually do it daily, and

– be able to show that you’ve been doing it daily

• If you’re running a test and the results are out of limits – Be prepared to show that indication was given to appropriate parties



QC Zen


Compliance Cycle

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QC Zen


University of Virginia’s approach to QC Performance


QC Zen


The case for QA – a physicist’s perspective

• QA is simply an aid to determine the “health” of an Imaging System – Mammography is good example [MQSA]

• Accrediting bodies beginning to request to view – and the ACR is starting to do spot inspections!

• Sets stage for how to deal with Quality issues when they arise. – Many times - used to indicate “Go - No Go” when in question

– Depending on personnel and situation- provides a “consultation opportunity”


QC Zen


Accrediting Bodies and QA

• QA now being mandated for diagnostic imaging

• Physicists reports are being examined for ACR accreditation – Physicist needs to represent an “adequate QC process in place”

• Doses more closely monitored between what is specified in sites’ protocols and the dose delivered in images submitted

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QC Zen


How do you accomplish your QA goals?

Thorough analysis of what is required vs. what is important or desired

State Regulations

Vendor Recommended

Societal Recommended

What the physicist wants

Accreditation Required

Your QA program


QC Zen


The Decision Tree: When do you do QA, who do you call when it fails?

• Having the process defined up front removes the burden from the tech to determine what to do in tricky situations


QC Zen


Overview of 3 Tiered Approach: UVA CT QA Method

➡ LEVEL 1 - Annual Inspections or Major check-ups

➡ LEVEL 2 - Weekly/ Monthly or Quarterly QA work

➡ LEVEL 3 - Daily QA work

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QC Zen


Overview of 3 Tiered Approach: UVA CT QA Method- Details

Who Does? When Done? What Done? What Goal?

Level 1 Physicist Annual or post-major service

Catphan 600 Dose Phantoms - 32cm & 16 cm

Dose monitoring- typical/standard protocols + random audits, collimation, High level Image Quality: Recon slice thickness, MTF, detailed linearity, detailed contrast

Level 2 QA Tech or Tech

Weekly or post-service

ACR 464 Gammex Phantom

Low level Image Quality: Evaluation of Uniformity, System Integrity, gross resolution, contrast/noise, system linearity and laser/slice table position accuracy

Level 3 Tech Daily Water Phantom or other vendor supplied phantom(s)

Evaluation of Uniformity, System Integrity


QC Zen


What makes a Quality QA program? Dedicated or Designated QA Technologist

ACR Accreditation Coordinator

Good list of written procedures

QA /Issues workflow document

UVA Method- Whether Vendor, Tech or Physicist initiated - all under Heading of “QA”

Good Communication

And… structure

A database or other cataloging software tool for trend analysis

We like digital archives of QA data

We REALLY like flags set that remind us when QA is overdue or FAILS


QC Zen University of Virginia Charlottesville, VA

• 578 bed academic hospital

• 12 affiliated locations

• 220+ imaging units (CT, MRI, FFDM, US…)

• 3 full time medical physicists

• TJC, ACR Accredited

• Situation in 2010 – Seeking automated solution to support vision for QC as a key component

of overall image quality

– Explored cost of building in-house QC system…


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QC Zen

UVA and the QC-Track journey

2012 2013 2014 2011

1. FFDM

2. CT

3. Aprons

4. New FFDM

site

5. PM/Service Tracking

2015


6. Nuclear Medicine

2016

7. US


QC Zen

Situation today… • Full digital QC for 3 modalities

• 9 FFDMs in 5 locations • 5 CTs in 2 locations • 6 Nuc Med units in 2 locations

• Apron tracking

• 3,000+ aprons in 41 locations

• 125+ users trained • Synergy between Physics and Biomed teams

Result: Responsible Parties now have centralized system to track status across locations

41 UVA Sites

QC Data

UVA Intranet



QC Zen


Compliance Cycle

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QC Zen So, you need a QC tracking system. What do you do?


Apron ID Who? Type

Date

Checked

1234 Dr. Smith skirt 1/1/2013

1235 Dr. Smith collar 1/1/2013

1236 Al 1/5/2013

?


QC Zen Options

1. Binders

2. Spreadsheets

3. Products


• Meet physicist requirements and inspector needs

– Need to have a QC plan, follow the plan, keep records

• Which means:

– Define QC workflow – by modality, room, location, tests, who performs QC and when

– Schedule QC activities and monitor that QC activities have been completed

– Record QC data, and process with calculations, baselines, limits/thresholds, date/time/user stamps

– Detect, notify and track QC failures

– Enforce security – access to QC records, changes to forms

– Generate reports needed to monitor QC processes and meet the information requirements of responsible parties

– Be able to back up the QC data (and recover)

Requirements


QC Zen Option 1: Binders • Source: Usually made up of forms provided by

ACR, physicists or manufacturer

• Advantages – “business as usual” – Inexpensive

– Accepted by inspectors

• Disadvantages – Manual scheduling, manual calculations, manual

failure notices

– Monitoring? difficult, not timely

– Usually need to “clean things up” before inspection

– Difficult to meet remote data access needs

– Only one person can use a binder at a time

– Security and control

– Backup and recovery


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QC Zen Inspector experience?

Binders vs. today’s complex facilities vs. today’s inspection requirements

• Per Dr. Browne: “a common issue is the organization of documents”

“I know we have it somewhere…”

• Result: inspector unhappiness! – A citation, if the requested document can’t be produced

by the time the inspector leaves

– Appeals are time consuming and expensive

– Even if appeal successful the citation remains on the record


Needed at point

of inspection

• QC Records • Credentials • PM/Service docs • Safety documents • …


QC Zen Option 2: Spreadsheets • Source: Usually “in house”

• Advantages

– Inexpensive – Able to build in calculations – Backup

• Disadvantages

– Testing? – Facility still relies on manual scheduling, manual failure

notices – Monitoring can be difficult – Reports can be difficult to build – Few controls around data modification or deletions so

difficult to identify if occurred – Only one person can use a spreadsheet at a time – Security limited to network access, cell locking – On-going support, if changes needed


Apron ID Who? Type

Date

Checked

1234 Dr. Smith skirt 1/1/2013

1235 Dr. Smith collar 1/1/2013

1236 Al 1/5/2013


QC Zen


How many technologists are “spreadsheeters”?

• Scenario: – Physicist preps spreadsheets and sends them to

the QC team

– What does the QC team do? • Not trained in Excel so they print the spreadsheets

and continue writing down QC data

• Result: inspector unhappiness! – Calculations (for limits)? Lost

– Any chance at remote monitoring? Lost

– Any chance at trend reporting? Lost

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QC Zen Option 3: Products • Source: professional software engineers

– Scope: “point” (apron tracking) or “complete” (Enterprise QC across modalities, per SEA 47)

– User: QC dashboard, QC scheduler, tests specialized for QC, reporting, multi-user, provisioning, secure

– Server: database, centralized, secure, revision management, audit logging

– Workflow: standardized or customized

– Other: on-going improvements, training, documentation, testing per professional standards

• Advantages – Complete solution – that can cover normal and uncommon (holidays, down for PM)

circumstances

– Training and documentation

– On-going support and upgrades

– Collective needs and ideas from multiple locations are built into a product

• Disadvantages – Expenses for licensing + support

– Vendor might have limited experience with your specific area of interest

– Control over improvements



QC Zen

Enterprise web-based device QC and credential tracking

59 April 27, 2016

Atirix product: the QC-Track® system

Copyright (c) 2016 Atirix Medical Systems, Inc.

Aprons DBT/FFDM/CR-FFDM CT MRI Nuc Med/PET/Fusion Fluoro US CR/DR DXA CEU/CME/Exams PM/Service

Modality QC • MQSA device QC for DBT/FFDM/CR FFDM and accessories • State, ACR/AAPM, and vendor QC for fluoroscopy/C-Arm,

US/Breast US, DXA, stereo biopsy and CR/DR • ACR and vendor QC for MRI/Breast MRI • ACR and vendor QC for CT • ACR and vendor QC for Nuc Med, PET and Fusion

Credentials • ACR CEU/CME and exam tracking

Aprons • Apron QC with integrated barcode tags

PM/Service Tracking • Preventive Maintenance and Service Tracking, with integrated

email and failure tracking

Enterprise QC Tools • Enterprise Dashboard • Document Management


QC Zen

Email Notices, Reminders, Warnings

QC Data, Electronic Documents

April 27, 2016 60

QC Data Repository

Dashboards, Email Notices, Reminders, Warnings , Reports


QCIS™ Quality Control Information System

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QC Zen

61

So, how does it work? 1. QC notification The QC Dashboard or a QC-Track email notice indicates QC tests are due for a device or an apron.

April 27, 2016

4. QC Reporting QC data available for tracking and reporting, including MQSA, TJC aprons, ACR, and custom reports.

3. QC Data entry. Results are matched to devices and tests, comments added, and data is entered into QC-Track. Failures are recorded and tracked. Apron Tag indicators are updated.


2. QC data gathering QC data is gathered from the room, device or apron. Phantom data is gathered and processed.


QC Zen

CASE STUDY:

ENTERPRISE QC AT SUTTER PAMF


Sutter PAMF

January, 2015


QC Zen Case Study: Palo Alto Medical Foundation

• Background – Sutter Health, 10th largest US healthcare

system, is based in Sacramento

• Sutter PAMF – 20+ hospitals and outpatient clinics

– Jim Holder, Director of Imaging • 1981, Nuc Med Tech

• 2000, Manager

• 2013, Director

– Enterprise QC project

– Funded: 2015, with IS involvement • IS requested an SBAR as part of the funding process

The Palo Alto Medical Foundation has hospitals and clinics all over the bay area with convenient locations located in the California Bay Area of San Francisco, San Jose, Santa Cruz, Los Gatos and the East Bay.


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QC Zen PAMF situation prior to QC-Track

• Manual QC practices

• Lots of Binders

• Lots of modalities, with inconsistent practices across locations

• Lots of locations, so difficult to easily monitor QC status

• Lots of inspectors: California DPH, ACR, MQSA, NRC, IMQ,… – DPH, ACR – “on the spot” inspections



QC Zen So, why enterprise QC?

• Jim Holder: “back to my nuc med days”

– Reality: 30+ years being regularly inspected

– Jim’s Goal: Make it as easy as possible for the inspectors

• QC as simplistic as possible

– Electronic system: “big benefits”

• Easier and faster for inspectors

– In California, inspectors regularly perform soft reviews using QC-Track

• Minimizes/eliminates staff disruption prepping for inspection

• Minimizes staff disruption when the inspector is in the department

“The shorter the time the

inspector is in the

department, the easier it is

on me!”



QC Zen

– 30 QC Departments across 20+ physical locations

– Standardized device QC for 8 modalities across 116 imaging units • Mammo 19 • Stereo 3 • CT 12 • MR 9 • Fluoro/C-arm 27 • US 32 • Nuc Med 5 • PET/SPECT 3 • Dexa 6

– Plus:

• 1,100 aprons

• 145 professional credentials

• PM/Service tracking

Implementation Summary


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QC Zen


Aprons (1,000 across 30 locations)

Credentials (145)

Device QC (116 units, 8 modalities, 30 QC dashboards, 100+ users)

Camino Division

Santa Cruz Division

Alameda Division

Palo Alto Division

QC-Track.Planner for PM/Service Tracking

Enterprise Dashboard

Trend Reporting

Worksheet Editor

Sutter PAMF QC-Track Enterprise Server

Enterprise QC Data Repository (data, documents)

QC

Do

cum

ent

Man

agem

en

t

Security Mgmt

Device Mgmt

Audit Logging

Failure Tracking

Scheduler

Worksheet Mgmt

Rep

ort

ing

Engi

ne

Email Engine

DICOM-Connector

Test Server

Test QC Data Repository

SMTP

LDAP System Health Monitor

Atirix Support

Monitoring


QC Zen

CASE STUDY:

THE SBAR AT SUTTER PAMF

Sutter PAMF

January 2015



QC Zen SBAR decision document used by PAMF to help justify centralized QC system

Situation

Background

Assessment

Recommendation


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QC Zen SBAR Primer

SBAR is an effective and efficient way to communicate important information.

S=Situation - a concise statement of the problem

B=Background - pertinent and brief information related to the situation

A=Assessment - analysis and considerations of options — what you found/think

R=Recommendation - action requested/recommended — what you want

SBAR offers a simple way to help standardize communication and allows parties to have common expectations related to what is to be communicated and how the communication is structured. • The safety attitudes questionnaire administered at Kaiser Permanente identified that physician and nurse

perceptions of teamwork were significantly different. Physicians tended to view the care environment as fairly collaborative, whereas nurses saw it as much less so.

• To address the issue, Kaiser developed a communication tool that was adapted from the US Navy, called SBAR.

• Michael Leonard, MD, Physician Leader for Patient Safety, along with colleagues Doug Bonacum and Suzanne Graham at Kaiser Permanente of Colorado (Evergreen, Colorado, USA) developed this technique.

Institute for Healthcare Improvement, ihi.org


“Conversational Return On Investment Analysis”


QC Zen

• MQSA and the ACR require each site that performs Mammography to complete several quality control tests on the Mammography unit, (daily, weekly, monthly, etc). The recording of these results is currently done manually, where the Technologist documents the test results on paper graphs and charts and kept in a binder.

• Technologists, Radiologists, and Physicists (Tech/Rad/Phys) are required to maintain their license current, keep copy of their initial training in Mammography, and maintain a certain number of credits over a rolling time period. This is currently done manually, where copies of each are kept in a binder at each site that performs Mammography.

Actual SBAR: Situation



QC Zen

Each site performing Mammography must perform daily, weekly, monthly, quarterly, semi-annually, and annual quality control tests, which are all documented by hand on paper. These original paper logs are subject to be destroyed by a flood, fire, or person, or even lost. It is required that these documents be kept from inspection to inspection, which is done annually.

Each Tech/Rad/Phys maintains their initial training, licenses, and continuing education credits from year to year. They must send a copy of everything to each site that performs Mammography whenever there is a change. Because each person is on a different schedule, there are always changes and updates to the person’s file, which is maintained by the site.

Actual SBAR: Background


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QC Zen

• Any manual process opens up the potential for errors. An error in the Mammography quality control process can result in the department being shut down or subjected to fines.

• A back up or copy of all quality control tests would also be a manual process because the originals are all done by hand. All original charts and graphs have the potential to be lost or tampered with, and are exposed to fire or water damage.

• At least 1 person in charge of maintaining the training, licenses, and continuing education credits for each Tech/Rad/Phys at each Mammography site. This person requests copies of the updated material when it expires for each Tech/Rad/Phys that works at that site. This ultimately is the responsibility of the individual, but lack of compliance can result in fines and/or closures for the site.

• During each annual inspection, the inspector goes through all the binders that hold the QC test results and Tech/Rad/Phys credentials. Their assessment of the site is based on what they find/don’t find in those manual logs.

Actual SBAR: Assessment



QC Zen

• Provide a web-based system to record quality control tests and required Technologist, Radiologist, and Physicist documentation.

• This system can/will: • Streamline how each site records the data collected so it’s the same,

correct way across all of the [hospital] sites, reducing the chance for human error.

• Provide automatic quality alerts throughout the [hospital] network so the proper people are notified as soon as a QC test does not pass or when a Tech/Rad/Phys has expired credentialing.

• Allow the sites’ Imaging Technical Consultants and Physicists to review the QC process and track credentials remotely.

• Provide inspectors a neatly organized report of all test results and credentialing, which will streamline and speed up the inspection process.

• Speed up the time it takes for the QC Mammography Tech to complete the recording process of all the required tests, which can allow for additional patients to be seen.

Actual SBAR: Recommendation



QC Zen

CASE STUDY:

ACR INSPECTION EXPERIENCE

University of Virginia

February 2016


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QC Zen ACR Inspection Process

• UVA got a one week notice

• The ACR sent an inspection prep package – 25 pages!

• The ACR inspector was on-site for one day

• The ACR provided a post-review report



QC Zen Here’s how to think about ACR inspections


ACR List Inspected by physicist

On site day of the inspection


QC Zen Case Study: CT

• Situation: – QC-Track installed for past 4 years

– Follow UVA workflow daily

– Automated analysis in place

• Inspection Process: – Structure in place so very fast -- 5 minutes! – Reviewed each scanner and reviewed

credentials

• Results: – Site needed to have all credentials –

including non-ACR for cardiologists – Ensure that the actual serial # of the

Console agrees with the physicist report agrees with the device serial # at the ACR


ACR Inspection 2016

Inspector Happiness Hint:

Some ACR inspectors do look for serial nu mbers, bu t knowing th is is di fficu lt to track, mismatch ed serial nu mbers wi ll not be noted in th e written report.

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QC Zen Case Study: NM

• Situation: – Started using QC-Track in September, 2015 – 6 units, 12 counters and probes

• Inspection Process:

– Matched the records to their inspection documents

• Results: – Needed to prove annual review of safety documents – Recommended that the technologist team use a phantom more

frequently – quarterly, instead of semi-annual

• Response:

– Added an Annual Document Review worksheet within QC-Track – Considering Jaszczak Phantom for possible automated analysis


Inspector Happiness

Hint: With a QCIS you can respond immediately to an issu e and SHOW the inspector the fix. For example, “recommend testing the phantom qu arterly not semi-annually” , s imply show them the changed test schedule.

ACR Inspection 2016


QC Zen Case Study: US

• Situation: – Lots of units: 27 base units and 77 probes

– No QC-Track, all binders and spreadsheets

– QC work divided between physicists and biomed at main location and remote

• Inspection Process: – Less structured and more time consuming because no

electronic tracking system

• Results: – On-site physicist needs to own the QC process – Suggested the site perform the QC at the high end of the

recommendations

• Response: – Implement a structured QC system, with physicist

overseeing the QC process and biomed performing


ACR Inspection 2016

Inspector

Happiness Hint: We were su rprised by the recommendation to do QC at the h igh end. Then we saw a recent informal su rvey on the physicist l is tserv indicating an average fai lu re rate of 10% on transdu cer QC du ring yearly physicist su rveys


QC Zen

CASE STUDY:

TJC INSPECTION EXPERIENCE

University of Virginia

March 2015


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QC Zen Case Study: Aprons

• Situation: – 2,400+ aprons across 38 locations – QC-Track for four years

• Inspection Process, Spring 2015:

– TJC Inspector found apron item with tracking tag

– “I see you have it tracked. Can I see the report that shows it has been inspected”

• Results: – UVA Response: Scanned the Tag and brought up the

QC-Track Apron Inspection report – Post inspection – TJC complimented the tracking

approach



QC Zen Apron QC – Fluoro? • Advice from Dr. Browne: consider other

clinically supported methods for apron QC

– Tactile inspection minimizes dose exposure to the professionals

• Advice from Allen:

– Do what your state says you need to do

– If OK, use a tactile inspection – does it feel like all of the material has fallen to the bottom of the item?

• If so – CT scout to confirm

• CT is preferred as an alternative to fluoro since zero dose to the tech



QC Zen

WHAT’S ON THE HORIZON?

FLUOROSCOPY, TJC AND AAPM TG272

NEW ACR MAMMOGRAPHY QC PROCESS


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QC Zen Fluoroscopy and heightened QC requirements


• The Joint Commission is likely to add fluoroscopy QC to Diagnostic Imaging Requirements – Goal: circulate plans for comment in

2017, introduce regulations in 2018

• States aren’t waiting – California Department of Public Health

• TJC is moving in parallel with the AAPM’s Task Group 272

“The industry has responded to dose concerns with CT.

Are we now going to focus on the rooms that have the capacity to generate equivalent if not more patient dose?

Does QC emphasize checking the dose metrics of the devices?”

Allen Goode


QC Zen TG 272



QC Zen AAPM - TG 272

• Formed in 2015 to unify previous work on dose checking to create a common understanding, including:

– Output parameters coming from a room to more accurately determine dose

– How to make different systems give equivalent information

• Shades of XR-27/XR-29? FDA may be looking to add a phantom requirement to the QC manuals for new fluoroscopy units


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QC Zen Mammography and the unified ACR QC program – 2/17/2016



QC Zen Mammography and the unified ACR QC program

• Chair: Eric Berns, PhD – “I’d love to talk, but… we’re in a quiet period“

• What a process! – ACR committee started in 2008, then tomo systems emerged…

– FDA approval in Feb 2016 of new program and phantom – but only for 2D (FFDM) systems

• “The FDA alternative standard specifies that the new manual may be used only for full-field digital mammography systems without advanced imaging capabilities (e.g., tomosynthesis and contrast enhancement).” (ACR website, FAQ)

– Per ACR web site: “The manual is currently undergoing preparation for publication and should be available this spring”



QC Zen


Standardize: ACR for Mammography

Advantages • Simpler, with few or no

calculations for the techs

• Easier for the inspector, esp. in multi-manufacturer settings

Current approach Manufacturer-specific or ACR QC

ACR approach Standardized QC for all units

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QC Zen

• Remaining ACR Deployment Steps

– Near term: Phantom and manual availability

– Then: Tomography, Contrast

• Interested? You will need a physics inspection with new method before starting


Standardize: ACR for Mammography


QC Zen


“You look at where you’re going and where you are and it never makes sense, but then you look back at where you’ve been and a pattern seems to emerge.”

Zen and the Art of Motorcycle Maintenance Robert M. Pirsig


QC Zen A recap of tips to stay on the path to Inspector Happiness

• Structure, structure, structure!

– QC: “Plan it – Prove it”, and “Say it – do it!”

– Credentials

– Organized documents, accessible at time of inspection

• Work closely with your physicist!

• Inspector happiness = radiology director happiness!


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QC Zen Atirix Sponsorships

Thank you!


Copyright © 2016 Atirix Medical Systems, Inc. All rights reserved. Atirix® and QC-Track® are registered trademarks of Atirix Medical Systems, Inc.

QC-Track is protected by issued and pending patents, including U.S. 8,428,969 “System and method for tracking medical imaging quality” and continuations

Special thanks to Eric Berns, Chair ACR Mammography Committee,

Assistant Professor and Diagnostic Medical Physicist, Denver Health, UC Denver

Marion Boston, Assistant Director, ACR Andrea Browne, Medical Physicist, Dept. of

Engineering, TJC Jim Holder, Director of Imaging, Sutter PAMF Rania Johnson, Senior Director of Product

Management, Atirix Medical Systems Nancy Prouty, Medical Center Administrator, UVA

- For more information [email protected]

Atirix sponsors MTMI Mammography courses for technologists and physicists

Atirix is a Director’s Circle sponsor of the AHRA

Educational Foundation


QC Zen Additional information on QC-Track

• Contact [email protected] for private briefings, demos and QC reviews

• See www.Atirix.com for QC-Track information, brochures, QC blog, and recent presentations. A sample SBAR is available for download

• AHRA 2016, Nashville – Booth 621. Please stop by to say hi and get a demo!

– Atirix sponsors the Lean Six Sigma Workshop

• Also:

– MTMI Webinar on enterprise QC, Sept 22, 2016, 6PM CDT – details coming soon!

– California Society of Radiological Technologists (CSRT)

• Atirix will be a presenter in the CSRT Fall Virtual Conference, Mid November, 2016 – details coming soon!


mailto:[email protected]






http://www.atirix.com/