Life Cycle of A New Point of Care Test Request. Managing the Chaos

Similar documents
Quality Assurance Program For Hospital Based Point of Care Testing. Presented by: Jeanne Mumford, MT(ASCP) Pathology Supervisor, QA Specialist

Internal Lab Inspections: Are You Inspection Ready? Presented by: Jeanne Mumford, MT(ASCP) Manager, Point of Care Testing, JHM

Subject: Quality Management for Origin date: 3/06 Point of Care and Waived Testing Reviewed: 2009 /2010 Revised: 2/2009

CAP Most Frequent Deficiencies and How to Avoid Them. March 11, 2015

PROGRAM GUIDE - UNIVERSITY CLIA REGISTERED LABORATORIES COMPLIANCE COMMITTEE

Plan for Quality to Improve Patient Safety at the POC

Catholic Health Initiatives

Improving Your POC Program: An Upside Down Map. Sheila K. Coffman MT(ASCP)

Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

Rapid Specimen Testing In the Medical Office (POCT)

Point of Care Testing Clinical Practice Standard and Policy (LTR31449) Version: 2.01

Laboratory Risk Assessment: IQCP and Beyond. Ron S. Quicho, MS Associate Project Director Standards and Survey Methods, Laboratory July 18, 2017

Hannah Poczter, AVP, Laboratories, Cari Gusman, Administrative Director, Ed Giugliano, PhD, Project Manager, Certified Six Sigma Black Belt

SUCCESSION PLANNING: FILLING A LABORATORY DIRECTOR S SHOES PART ONE

Policy Subject Index Number Section Subsection Category Contact Last Revised References Applicable To Detail MISSION STATEMENT: OVERVIEW:

Point of Care Testing

3/14/2016. The Joint Commission and IQCP. Objectives. Before Getting Started

Point of Care Quality Management. Procedure. Approving Authority: President and CEO, Keith Dewar

EDUCATIONAL COMMENTARY KEY COMPONENTS OF AN INDIVIDUALIZED QUALITY CONTROL PLAN

THE VALUE OF CAP S Q-PROBES & Q-TRACKS

Surviving Katrina: How Touro Infirmary Met the Challenges of the Disaster! Paula McCreary MT(ASCP) Technical Manager Pathology Department

Standards for Laboratory Accreditation

The CLIA regulations..

What s New in Point-of-Care Testing (POCT)? Marjorie W. Doty, MT(ASCP)SBB OneBlood, Inc. St. Petersburg, FL

POINT OF CARE TESTING MED Laboratory Branch Kim DeGroat, RMLS - Frankfurt Region Wilfred Lovelock, RMLS - Dakar Region

Joint Commission Laboratory Accreditation: Why It Is Right For Your Organization

Standards for Forensic Drug Testing Accreditation

CAP Forensic Drug Testing Accreditation Program Standards for Accreditation

Clinical and Laboratory Standards Institute: Addressing POCT Needs; The Good, The Bad, and The Risky

Massachusetts General Hospital Point of Care Testing Program

CE Update [generalist compliance/regulation management/administration and training] COLA Accreditation An Educational Experience

: Suzanna Immanuel Place, date of birth : Jakarta, 11 th March 1953 Education : MD FMUI 1978 Profession : Clinical Pathologist (SpPK) FMUI 1984

TITLE: POINT OF CARE TESTING

IQCP. Ensuring Your Laboratory s Compliance With Individualized Quality Control Plans. November/December 2016

POCT Testing and Importance of Operator Lockout

VUMC Office of Research Research Core Facilities/Shared Resources 2015 Professional Development Track. Core Research Assistant I

Recent Veterans of Major EMR Launches Share Insights on Keys to a Robust Go-Live Command Center

Heart of America POC Group Quality Management Making it Meaningful

Point Of Care Testing in Emergency Departments

NT POCT Program Quality Framework and Initiatives

C A L I F O R N I A L A B O R AT O RY P E R S O N N E L

3. Does the institution have a dedicated hospital-wide committee geared towards the improvement of laboratory test stewardship? a. Yes b.

Nestor A.Guerrero,BSMT,RMT,CLS,MT(ASCP) Major (Ret), US Army Medical Service Corps

FEDERAL/STATE GUIDANCE OR COMMUNICATIONS NEEDED BY CLINICAL LABORATORIES

Performance of Point-of-Care Testing in Unaccredited Settings:

Improving the Delivery of Troponin Results to the Emergency Department using Lean Methodology

CHALLENGES IN POCT. Dr. Jayesh P. Warade. Consultant Biochemistry and Quality Manager, Meenakshi Mission Hospital and Research Centre, Madurai, India

PURPOSE: This policy provides an overview of SHANDS Jacksonville Laboratory s commitment to the care and safety of the patients we serve.

QC Explained Quality Control for Point of Care Testing

Today s Featured Speaker

COMMISSION ON LABORATORY ACCREDITATION. Laboratory Accreditation Program TEAM LEADER ASSESSMENT OF DIRECTOR & QUALITY CHECKLIST

Rules Based Orders. Good For Your Practice Today. And Tomorrow

STANDARDS Point-of-Care Testing

CLIA s New IQCP Requirements Are in Effect, or Are They?: Implementing Laboratory Risk Management Now to Ensure Success

The CAP Inspection Process

A COLA White Paper: FEDERAL GOVERNMENT QUESTIONS QUALITY IN WAIVED TESTING.


QC net in hospitals POCT. Marija Prezelj Institute of Clinical Chemistry and Biochemistry University Medical Centre Ljubljana, Slovenia

CLIA S NEW IQCP SEABB. March 19, Linda Sigg, MT(ASCP)SBB,CQA(ASQ) Staff Lead Assessor, Accreditation, AABB

Scope of Service. Department Mission

Individualized Quality Control Plan (IQCP) Frequently Asked Questions Date: May 5, 2015 (last updated 08/21/2017)

Organisation of a Clinical Laboratory. Peter O Loughlin SA Pathology

insights INTO Preparing Your Laboratory For Its Next Survey COLA S FALL 2016 ALSO IN THIS ISSUE: Letter from the Chair... 2

How to Improve the Laboratory Experience CLS and MLT Working Together

Session Number 208 LAB POTPOURRI WHAT EVERY CRITICAL CARE NURSE NEEDS TO KNOW ABOUT COMMON LABS

CLIA & Individualized Quality Control Plan (IQCP) Karen W. Dyer MT(ASCP), DLM Director (Acting) Division of Laboratory Services

Fairview Health Services

Parkland Health & Hospital System Department of Pathology Research Support

Information Collection Challenges: A Global Health Perspective. Bob Sokolow APHL Global Health Consultant APHL Annual Meeting June 2, 2013

SAMPLE. Essential Tools for Implementation and Management of a Point-of-Care Testing Program

Dominic Cox Royal Free Hospital London Joan Pearson Leeds General Infirmary

Sunquest Collection Manager Nurse and PCT Workflows. June 2012

GUIDELINE FOR HANDLING FOMEMA SPECIMEN

Tutorial: Basic California State Laboratory Law

Ontario Shores Journey to EMRAM Stage 7. October 21, 2015

EMA Inspection Site perspective

US ): [42CFR ]:

Lab Quality Confab Process Improvement Institute. New Orleans, LA. John Waugh 11/3/2015

IMPROVING EFFICIENCY AND COST SAVINGS. Technology Solutions for NHS Hospitals

Right person. device time

QC for the Future: Laboratory Issues POCT and POL concerns

Saves counter space and money while improving in-house testing capability

COLA CATALOG WE GIVE YOU THE TOOLS TO SUCCEED RESOURCES FOR LABORATORY PERSONNEL EDUCATIONAL COURSES, PROGRAMS, AND MATERIALS

CLINICAL CHEMISTRY. Phone: The department is staffed 24 hours a day.

CME/SAM. Determination of Turnaround Time in the Clinical Laboratory

The CLSI Consensus Process: Making a Difference in Health Care David Sterry, MT(ASCP) Director, Standards Development, CLSI

Dr. Jones has served as the Director, Geisinger Regional Laboratories since 1985 and established the Ancillary Testing Program for Geisinger Medical

CHEYENNE REGIONAL MEDICAL CENTER AREA: TITLE: TrueConnect Downtime/Recovery Procedure. Page 1 of 1 NUMBER: ADMIN-IM-32 ORIGINATOR: CMIO

Masimo Patient SafetyNet

Leadership Communication for the POCC: Overcoming the Barriers of Productive Communication

Primary Ingredients. Primary Ingredients. Referrals. Positive cash-flow. Dedication & growth Give it some time and put effort into it

What s New and Improved for the Laboratory Program in 2013 April 23, 2013

Core Item: Hospital. Cover Page. Admissions and Readmissions. Executive Summary

Towards Sustainable Point-of-Care Testing in Remote Australia Brooke Spaeth BMedSc (Hons)

DEPARTMENT OF CLINICAL LABORATORY SCIENCES SCHOOL OF HEALTH TECHNOLOGY AND MANAGEMENT THE UNIVERSITY AT STONY BROOK STONY BROOK, NEW YORK

Symposium for Clinical Laboratories May 30 June 2, 2018: Session Descriptions

Using the epoc Point of Care Blood Analysis System Reduces Costs, Improves Operational Efficiencies, and Enhances Patient Care

Learning Objectives. Individualized Quality Control Plans. Agenda. Another Way To Determine QC? Hooray!!!! What is QC?

Click to edit Master title. style. Click to edit Master title. style. style 8/3/ Are You on Track?

Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services CLIA

Transcription:

Life Cycle of A New Point of Care Test Request Managing the Chaos

Speaker Introductions Jeanne Mumford, MT(ASCP) Manager, Point of Care Testing Johns Hopkins Medicine jmumfor3@jhmi.edu Quality Oversight of 2 Academic Hospitals and 3 Community Hospitals and 50+ Physician Office Laboratories 9 Full Time Point of Care Coordinators Standardizing Workflows and Managing Quality Oversight

Jeanne Mumford Disclosures Nonfinancial - Member of Board of Directors, COLA Resources, Inc, President, KEYPOCC Keystone Point of Care Coordinators; receives no financial compensation Financial Honorarium Author for AAFP POL Insight 2015A: Quality Assurance Program for Physician Office Laboratories Financial Honorarium Speaker- AACC, KEYPOCC

4

Johns Hopkins Medicine

List of Current POCT Interfaced Devices: ACT-LR, ACT Plus Creatinine INR Hgb Urinalysis HBA1c Glucose, whole blood O2 Saturation Blood Gases ph Strep A Rapid HIV 1/2 Antibody Rapid HCV Urine Drug Screen PPM Tear Osmolality Fecal Occult Blood Specific Gravity Urine HCG 6

Point of Care Coordinators

Objectives At the end of the session, participants will be able to: Identify key components in developing a formal approval structure for new test requests Recognize and overcome common IT issues when interfacing point of care devices Learn how to integrate new tests into your point of care program

Definitions Enterprise the university, all 5 hospitals and all ambulatory sites Facility single hospital POCC point of care coordinator JHH The Johns Hopkins Hospital JHM Johns Hopkins Medicine: Hospitals, University and Ambulatory August 15, 2017

New Test Request Form- Basics

New Test Request Form- Benefits

New Test Request Form- Funds

Who is a Part of the Decision Process? POC Committee (Enterprise-wide) 6-8 key members Lab Directors from each facility (5) Medical Director over POCT at JHM (Chairman) Overall goals and visions of this committee: Global vision to standardize test devices across facilities. More educated, insightful decision process with SME s in the latest technologies.

POCT vs. Central Lab Medical professionals considering POCT need to balance POCT s rapid turnaround and positive effect on patient care with the more robust results available through lab-based testing (David, 2016). Many factors to consider before implementing POCT: Pre-analytical, analytical and post-analytical errors (proper collection technique per device, application of sample, documenting results) Manufacturer s instructions (ex. off-label use) Good communication David, K. (2016, July 1). Point-of-Care Versus Lab-Based Testing: Striking a Balance. Clinical Laboratory News.

How the Decision is Made Decision is based off of information provided on the new test request form, as well as central laboratory reports, if needed. The POC Committee may want to meet with the requestor to go over this information and determine the best course of action.

You said, Yes, Now What?: New Device to Facility Brand new POC device to facility: Contact vendor for price quote (device, QC, reagents, linearity kit). Perform meter validation/check-in based on good laboratory practices. Perform correlation studies between new device and central laboratory, if available. Create procedure and competency assessment tools for training. POCC trains unit trainer(s), then unit trainer trains the staff.

You said, Yes, Now What?: Current Device Current device already in use at facility Contact vendor for price quote (device only). Perform meter validation/check-in based on good laboratory practices. Use current procedure and competency assessment tools for training. POCC trains unit trainer(s), then unit trainer trains the staff on their unit.

Vendors Use vendors and your training and QA program to actually train testing personnel. Vendor and industry support is important.

Trainer Sessions POCC trains unit trainers. Train the trainer sessions held annually. Go over any updates to policies and procedures. Ensure proper technique is being used to train new hires.

POC Advisory Meeting Includes unit trainers, patient care managers, Epic interface rep., clinical engineering, regulatory rep., nurse educators and POCC. Meetings are held monthly. Send out info frequently, but sometimes doesn t get communicated.

Work Together Use resources from other facilities to implement the new test. Experienced POCC s that have used the device. Nurse educators. Vendor reps.

Timeframe May take several months to implement a new POC device. Dependent on: Size of facility Number of POCC s Complexity of test Workload

Balancing Act New Test Requests Everyday Activities Prioritize by request date Set realistic timeframe Ensure completion of tasks Prioritize activities

Example 1: Hemoglobin in Renal Clinic (Outpatient) Need for immediate hemoglobin result in order to administer erythropoietin within clinic visit. This minimizes delay in patient care and having to schedule a subsequent appointment for treatment.

Example 2: Creatinine in Imaging (Inpatient/Outpatient) Need for immediate creatinine result in order to administer media contrast for imaging studies. Reduced procedure cancellations and need to reschedule appointments.

Example 3: BUN, Creatinine, Na, K, Mg in Cardiac Clinic (Outpatient) Need faster TAT for lab results to not delay treatment. Can cut visit time by 30%. Central lab had no complaints from clinic other than many samples were hemolyzed. Importance in communicating with central lab.

Challenges Clinical staff expecting implementation within an unrealistic timeframe. Communication between the requestor of the test and endusers. Retrieved from http://www.ideachampions.com/weblogs/ archives/2010/12/the_single_bigg.shtml

What Aids in a Successful Implementation? Responsive and dedicated vendor reps. Teamwork Effective communication Retrieved from http://www.practicalsoftwaresolutions.com/implementation-methodology.html

Enterprise Interface Infrastructure: Past Within our Health System, we had nothing in common Unable to troubleshoot and support POCCs

Johns Hopkins Hospital: Past Manually recording results in patient charts By sneakernet system, we would download instruments once a month to keep data Transcription errors

Enterprise Interface Infrastructure Present JHH BMC HC POC Middleware LIS EMR SH SM

Interface Infrastructure Glucose Vendor Middleware Creatinine Hgb Vendor Middleware Hgb A1C POC middleware LIS EMR INR Vendor Middleware ACTs Urinalysis Blood gases Vendor Middleware Aimee Craft TELCOR, Project Team Leader Point of Care Testing Solutions

POC Connectivity Today, your POCT program efficiency will depend on the instrument s rapid TAT combined with the fast access of the accurately integrated results. Example: Blood gas instrument in an ICU setting Futrell, K. (2016, September). Point of Care Testing: The Great Boom Ahead.

Connectivity Advantages Helps ensure that all care teams have access to patient results in a timely manner Monitor POC program from a centralized location Operator certifications are more manageable More control over large number of instruments QC and calibration documentation QA monitoring/ troubleshooting in real time You are not alone!

Pathways: Instrument to EMR Operator runs a test If ADT sent to instrument, Pat Information is displayed Scans a PID barcode Result Result is sent to the POC middleware Result is sent to LIS LIS creates order Result is posted to EMR

Instrument Connectivity How does this happen?

Who is Your Team Point of Care Coordinators Hospital IT representative multiple groups depending on connection types Vendor- including an IT expert LIS representative EMR representative Operator/nursing Billings representative

Vendor Support and Importance Need to be able to provide support for IT and POCCs Understand instrument connection capabilities Understand what type of barcodes instrument can handle, what type of information is accepted

Interface: Step by Step Questions to get started: - How are you connecting the instrument? - Do you need data jacks installed/ activated? - What steps are involved to send results? Extra steps for operators?

Interface: Connections Connection Type/Requirements: Wired connection: - Are network jacks available/ need new installation - Are they active - Does your Hospital IT have special requirements Wireless connection: - Is there a certificate required - Any expiration dates - Do you need dedicated IPs Get your Hospital IT involved

Interface: Instrument Testing Besides instrument validation, the interface set up needs to be tested, including: - Reporting units - Reference ranges - Critical action values - Instrument comments - Any calculated values - EMR result posting - Billing validation *It is a CAP requirement to check proper performance for an instrument interface when installed and after any modifications

Interface: Training POCCs Middleware functions Operator certifications Reagents set up Corrections Instrument Operators What steps are needed for the instrument to connect Basic connection troubleshooting Where to find results (Lab section)

Interface: Challenges - To meet expectations (i.e., transmission timing, location of results) - Instrument date/time must be accurate - Human factor, for instruments not automatically uploading - Wireless dead spots - Depending on institution s size, IP addresses availability: wireless traffic - Different IT regulations per site

Interface: Successes, Tips and Tricks - Learn from experiences - When testing, try to break the system - Knowing your Team - Having a POCC with IT knowledge

Enterprise Infrastructure: Future - Vendors become up to date with IT requirements (network security) - IT Harmonization - We embrace new technology and connectivity

Point of Care Testing JHM operates six academic and community hospitals. Hospital Beds Glucose Operators Johns Hospital 1,059 4,313 Bayview 545 1,300 Howard County 267 1,466 Sibley 318 800 Suburban 229 1,343 Johns Hopkins Community Physicians 39+ sites, 400+ providers, 1,600 glucose operators (primary and specialty care)

Integrating the System Whose procedures do we use Whose POCT devices? Whose workflows are the Best Practices?

Best Practices Steps to standardizing and harmonizing procedures, workflows and processes Now what? How to keep in touch and how to run this as one big complicated program?

Ongoing Monitoring Mock inspections and intracycle monitors Follow regulatory body checklist Enroll in a CLIA approved Proficiency Testing Program Perform semi-annual patient correlations Patient Safety Net (PSN) which allows for staff to submit lab issues and other patient safety concerns Safety Officers program Safety officers are engaged in the unit practices. Safety Officers include nurses, medical assistants, unit managers, providers

Ongoing Monitoring Schedule internal audits or inspections to each unit Inspect all storage areas where POC supplies are kept Look for open and expiration dates on all POC containers and/or test kit/devices Observe testing and sample collection techniques Review all Quality control and patient documents Inspect devices/instruments Look for QC liquid on device surfaces Ensure that back up batteries are charging Ensure that docking stations are properly plugged in and charging devices

Ongoing Monitoring Host a monthly meeting with the major lab vendors such as Quest, Lab Corp and Johns Hopkins Medical Lab Review cancellation reports Trends in cancel reasons Education Supplies Courier schedules New Test Codes New Specimen Collection Devices

Communication? Maybe? Attention: Toilet ONLY For Disabled Elderly Pregnant Children

Communication Cycle Sender Feedback Message Receiver Channel

The Message Sender Feedback Message Receiver Channel

Suggestions from Hopkins Monthly Meetings Testing Personnel Unit Managers Trainers Standards of Care (Monthly, as Needed) Nursing Representation from every Discipline

Have You Considered? Host a monthly meeting with the major lab vendors such as Quest, Lab Corp and Johns Hopkins Medical Lab Review cancellation reports Trends in cancel reasons Education Supplies Courier schedules New Test Codes New Specimen Collection Devices

Vendor Support/Training Utilizing Vendor Reps for support in training Vendor reps are brought into sites to perform on site training with our competency checklist Vendor reps have a great report with sites and reach out several times a year for support

More Tools Quarterly Flyers Published by Nurse Educations Screen Savers on Computers Across Hospital Campus Attending Team Huddles and Staff Meetings

Less Is More Nurse Educators can help POCC s learn how to trim down their message in order to have meaningful exchange of information Nurses and clinical care teams techniques Balancing clinical demands with laboratory regulation demands

Empathy In Communication Understanding someone else s perspective How does it impact the nurse or tech if they have to troubleshoot QC on a meter when a patient is crashing and needs an urgent glucose result? August 15, 2017

Empathy In Communication Let the nurse or tech state their point of view While meeting regulatory requirements, you may still work with clinical teams to meet their needs Take the time to check regularly that the message is still meaningful

Good Communication Is Key For Patient Safety Poor communication is reported as the root cause in 70% of hospital sentinel events and in 40% of malpractice cases due to medical errors. Keynote Session, Safety, Quality and Patient-Centered Care Peter Pronovost, MD, PhD, FCCM Sr. Vice President for Patient Safety and Quality Director of the Armstrong Institute for Patient Safety and Quality Johns Hopkins Medicine

Summary

Our Accomplishments So Far Standardized IT platform for Point of Care tests across 5 Hospitals and Ambulatory Medicine Will allow for quality indicators across the enterprise Will allow for centralized reporting and oversight Standardized electronic medical record One Patient, One Record Standardized laboratory information system Harmonized test panels Standardized testing platforms Chemistry and Hematology lines One Patient, One Test Result

Future Goals Electronic Audit/Rounding Tool Real time grading and feedback on tablets Networking Events for all POCC s No New POCT Devices Without Interface Capabilities Managing Non-laboratory Devices Through Middleware (i.e., transcutaneous bili)

Questions Jeanne Mumford, MT(ASCP) Pathology Manager, Point of Care Testing jmumfor3@jhmi.edu Johns Hopkins Hospital