QC Zen and the Art of Inspector Happiness

Transcription

1 April 27, 2016 and the Art of Inspector Happiness 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 DISCLOSURES 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 Atirix sells the QC-Track system for enterprise QC - Atirix client, informal advisor - Member, Global Advisory Board, Radimetrics/Bayer - Member, AAPM TG Inspector, State of Virginia 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 CQC? Dose? Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

2 Agenda 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, All the world now follows MQSA Dr. Stewart Bushong Baylor Medical Center Medical Imaging: More Than Fifty Shades of Grey. AHRA Annual Conference July 20, 2015 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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! Bill Clinton George Bush Ross Perot Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

3 Minneapolis own Prince was rocking the culture Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Yes, there were computers and cell phones IBM PS1 Motorola bag phone Windows 3.1 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, There were early imaging systems, but it was 1994 before the first 2 slice CTs hit the market Elscint 2 slice CT Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

4 And in 1994 inspectors were getting ready for MQSA Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Medicare 6,800 Mammo Screening facilities under quality regs MQSA 11,000 Mammo Screening and Diagnostic facilities under MQSA quality regs and needing an annual survey Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, What did HCFA find out about inspections? 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. 45 of 87 facilities had no knowledge of the regulations Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

5 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, so back to now, 2016 Regulation Compliance Cycle Knowledge -> Performance -> Documentation Compliance Cycle 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 MQSA 13,000 units TJC 30,000+ CT MR PET Nuc Med Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, MQSA QC Failure Tracking Technologist credentials Sign-offs??? Service reports Radiologist credentials Physicist reports MRI QC Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

6 Compliance Cycle Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, All the world now follows MQSA Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Device Quality Control Credentials Inspections Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

7 The Joint Commission and diagnostic imaging QC TJC Diagnostic Imaging Requirements August 10, 2015 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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? Dr. Andrea Browne, TJC AHRA Annual Meeting, Jul 21-24, Las Vegas Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Diagnostic Imaging Requirements & technologists Quality Control Quarterly dosimetry review MRI safety risks Construction shielding CT Physicist Credentials CT Annual Dose Analysis and Physics MR Annual Physics Nuc Inspector Med Annual happiness Physics hint: PET So Annual far the most common Physics issu es seen by TJC MRI are injury in data MRI Safety CT dose incidents Protocols CT Technologist Credentials MR Technologist Credentials CT Dose Tracking by Exam Correct Patient Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

8 TJC Diagnostic Imaging Requirements Plan it. The organization identifies quality control and maintenance activities for CT, PET, MRI, and NucMed. Equipment and activities Frequency and by whom Prove it. The organization maintains the quality of the... images produced. TJC review: Observation Logs Dr. Andrea Browne, TJC AHRA Annual Meeting, Jul 21-24, Las Vegas Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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: Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

9 ACR Accreditation and Quality Control Continuous Quality Control program Details are found in the modality Accreditation Program Requirements document Includes: Quality Control Personnel Qualifications Preventive Maintenance/Service requirements 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 Inspector Happiness CT Accreditation Program Requirements Hint: If you r CT, MR, PET and Nu c Med u nits are not ACR accredited th en you r TJC inspector will be looking for you to follow th e QC defined by you r manu facturer Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, ACR Accreditation BICOE Breast Imaging Center of Excellence 1, 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. Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, ACR Accreditation DICOE 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

10 New: ACR Basic vs. Advanced 10 Modality Accreditations Breast Imaging Center of Excellence Diagnostic Imaging Center of Excellence Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Regulations State TJC MQSA ACR AIUM MIPPA IAC Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

11 Physicist Radiologist Technologist 4/26/2016 Device Quality Control Credentials Inspections Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Imaging credentials CME/CEU and Exams Required at the point of inspection Inspector Happiness Hint : A common inspection issu e is physician and physicist credentials not on -site Challenge: Clinical professionals work in multiple locations, and each location required to have a copy Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Credentials TJC: Advanced-level certification in CT required (effective Jan 1, 2018) new 2/16/16 MQSA/ACR MG ACR CT and MR TJC/ARRT Continuing Experience (exams/months) Continuing Education (CEU/months) Continuing Experience (exams/months) Continuing Education (hours CME/months) Continuing Experience (surveys/months) Continuing Education (CEU or CME/months) 200/24 CT dose training MR safety training 15/36 24/24 ARRT - 24/24 or NMTCB 960/24 General /36 Specific - 60 /36 Cardiac 50/24 15/36 General - 150/36 Specific - 15/36 Facilities: 2/24 Units: 6/24 Units: 2/24 ABR - 1 PQI project/36 15/36 15/36 ABR 75/36 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

12 Device Quality Control Credentials Inspections Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Inspections State depends TJC MQSA ACR 1 year month random 3 year MIPPA Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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) Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

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

14 University of Virginia s approach to QC Performance Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

15 How do you accomplish your QA goals? Thorough analysis of what is required vs. what is important or desired Vendor Recommended State Regulations Your QA program Societal Recommended Accreditation Required What the physicist wants Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

16 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 Level 2 QA Tech or Tech Weekly or post-service Catphan 600 Dose Phantoms - 32cm & 16 cm ACR 464 Gammex Phantom Level 3 Tech Daily Water Phantom or other vendor supplied phantom(s) Dose monitoring- typical/standard protocols + random audits, collimation, High level Image Quality: Recon slice thickness, MTF, detailed linearity, detailed contrast Low level Image Quality: Evaluation of Uniformity, System Integrity, gross resolution, contrast/noise, system linearity and laser/slice table position accuracy Evaluation of Uniformity, System Integrity Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

17 UVA and the QC-Track journey 1. FFDM 5. PM/Service Tracking 2. CT 4. New FFDM site 6. Nuclear Medicine 7. US 3. Aprons Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 41 UVA Sites UVA Intranet QC Data Result: Responsible Parties now have centralized system to track status across locations Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Compliance Cycle Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

18 So, you need a QC tracking system. What do you do?? Date Apron ID Who? Type Checked 1234 Dr. Smith skirt 1/1/ Dr. Smith collar 1/1/ Al 1/5/2013 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Requirements 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) Options 1. Binders 2. Spreadsheets 3. Products Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

19 Inspector experience? Binders vs. today s complex facilities vs. today s inspection requirements Per Dr. Browne: a common issue is the organization of documents Needed at point of inspection QC Records Credentials PM/Service docs Safety 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Option 2: Spreadsheets Source: Usually in house Advantages Inexpensive Able to build in calculations Backup Date Apron ID Who? Type Checked 1234 Dr. Smith skirt 1/1/ Dr. Smith collar 1/1/ Al 1/5/2013 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

20 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Atirix product: the QC-Track system Enterprise web-based device QC and credential tracking 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 and failure tracking Enterprise QC Tools Enterprise Dashboard Document Management Aprons DBT/FFDM/CR-FFDM CT MRI Nuc Med/PET/Fusion Fluoro US CR/DR DXA CEU/CME/Exams PM/Service Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, QCIS Quality Control Information System Notices, Reminders, Warnings QC Data Repository Dashboards, Notices, Reminders, Warnings, Reports QC Data, Electronic Documents Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

21 So, how does it work? 1. QC notification The QC Dashboard or a QC-Track notice indicates QC tests are due for a device or an apron. 2. QC data gathering QC data is gathered from the room, device or apron. Phantom data is gathered and processed. 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. Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Sutter PAMF January, 2015 CASE STUDY: ENTERPRISE QC AT SUTTER PAMF Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Case Study: Palo Alto Medical Foundation Background Sutter Health, 10 th largest US healthcare system, is based in Sacramento 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. 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

22 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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! Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Implementation Summary 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

23 QC Document Management Reporting Engine 4/26/2016 Enterprise Dashboard Device QC (116 units, 8 modalities, 30 QC dashboards, 100+ users) Palo Alto Division Alameda Division Santa Cruz Division Camino Division Credentials (145) Aprons (1,000 across 30 locations) QC-Track.Planner for PM/Service Tracking Trend Reporting Worksheet Editor Sutter PAMF QC-Track Enterprise Server Worksheet Mgmt Audit Logging Scheduler Failure Tracking Device Mgmt Security Mgmt Engine Enterprise QC Data Repository (data, documents) LDAP SMTP DICOM-Connector Test Server System Health Monitor Test QC Data Repository Atirix Support Monitoring Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Sutter PAMF January 2015 CASE STUDY: THE SBAR AT SUTTER PAMF Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, SBAR decision document used by PAMF to help justify centralized QC system Situation Background Assessment Recommendation Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

24 SBAR Primer SBAR is an effective and efficient way to communicate important information. S=Situation - a concise statement of the problem Conversational B=Background - pertinent and brief information related to the situation Return On A=Assessment - analysis and considerations of options what you Investment found/think R=Recommendation - action requested/recommended what you want Analysis 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Actual SBAR: Situation 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. Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Actual SBAR: Background 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. Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

25 Actual SBAR: Assessment 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. Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Actual SBAR: Recommendation 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. Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, University of Virginia February 2016 CASE STUDY: ACR INSPECTION EXPERIENCE Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

26 ACR Inspection Process UVA got a one week notice The ACR sent an inspection prep package 25 pages! The ACR inspector was onsite for one day The ACR provided a postreview report Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Here s how to think about ACR inspections ACR List Inspected by physicist On site day of the inspection Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 difficu lt to track, mismatch ed serial nu mbers will not be noted in th e written report. Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

27 Case Study: NM ACR Inspection 2016 Situation: Inspector Happiness Started using QC-Track in September, 2015 Hint: With a QCIS you can 6 units, 12 counters and probes respond immediately to an issu e and SHOW the Inspection Process: inspector the fix. For Matched the records to their inspection example, documents recommend testing the phantom qu arterly not Results: semi-annually, simply show Needed to prove annual review of safety them documents the changed test Recommended that the technologist team schedule. 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Case Study: US Situation: Lots of units: 27 base units and 77 probes ACR Inspection 2016 Inspector Happiness Hint: We No QC-Track, all binders and spreadsheets were su rprised by the QC work divided between physicists and biomed recommendation main to do location and remote QC at the high end. Inspection Process: Then we saw a recent Less structured and more time consuming because informal no su rvey on the electronic tracking system physicist listserv indicating an average Results: failu re rate of 10% on On-site physicist needs to own the QC process transdu cer QC du ring Suggested the site perform the QC at the high end of the yearly physicist su rveys recommendations Response: Implement a structured QC system, with physicist overseeing the QC process and biomed performing Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, University of Virginia March 2015 CASE STUDY: TJC INSPECTION EXPERIENCE Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

28 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, FLUOROSCOPY, TJC AND AAPM TG272 NEW ACR MAMMOGRAPHY QC PROCESS WHAT S ON THE HORIZON? Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

29 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 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 TJC is moving in parallel with the AAPM s Task Group 272 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, TG 272 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

30 Mammography and the unified ACR QC program 2/17/2016 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 fullfield 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Standardize: ACR for Mammography Current approach Manufacturer-specific or ACR QC ACR approach Standardized QC for all units Advantages Simpler, with few or no calculations for the techs Easier for the inspector, esp. in multi-manufacturer settings Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

31 Standardize: ACR for Mammography 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, 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! Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,

32 Thank you! 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 Atirix Sponsorships Atirix is a Director s Circle sponsor of the AHRA Educational Foundation Atirix sponsors MTMI Mammography courses for technologists and physicists - For more information QC-Answers@Atirix.com 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 Copyright (c) 2016 Atirix Medical Systems, Inc. April 27, Additional information on QC-Track Contact qc-answers@atirix.com for private briefings, demos and QC reviews See 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! Copyright (c) 2016 Atirix Medical Systems, Inc. April 27,