WEBINAR: IQ, OQ, PQ – the 3 Pillars of Validation

If you missed this presentation on October 24th, you can watch it HERE

 

Please join us for a presentation by Validation expert, Suzanne Butch. Suzanne will be reviewing the 3 pillars for maintaining a validated state. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Suzanne H. Butch, MA, MLS(ASCP)SBBCM, DLMCM, CQA(ASQ) Michigan Medicine, Department of Pathology

Suzanne H. Butch, received her Bachelors in Medical Technology from the University of Michigan and has a Specialist in Blood Bank certification. She serves in numerous positions of leadership with AABB, Michigan Association of Blood Banks, ICCBBA, American Society for Clinical Laboratory Science, CLSI, and more. Her extensive history of publications, invited lectures, and workshops has made her a sought-after expert in her field.

Webinar will be held Tuesday October 24th at 1:00 pm EST.   Click Here to Register

Here We Grow Again:

Now Accepting Resumes.

BC Solutions is looking for Medical Technologists with experience in in Transfusion Medicine and Blood Bank and/or Donor computer systems.  Our work is performed remotely* and requires self-motivated personalities who are detailed and process oriented. Strong communication skills with strong commitment to patient safety and serving the blood bank community are key to our culture.

Experience in one or more of the following software systems is required:  Cerner Millennium and PathNet, Mediware HCLL and LifeTrak, SCC SoftBank and SoftDonor, Sunquest Blood Bank, Haemonetics SafeTrace Tx and El Dorado Donor, Meditech Blood Bank, MAK eProgesa, and EPIC. Software Database Management ability is a plus.

If you would like to discuss opportunities with us, please send your resume to info@bcsolutionsrfn.com, or call us directly at 480-346-7011.

*travel and onsite work is also available, please let us know if you are available for projects involving travel.

2017 Schedule of Events

LET’S TALK.  Each project we take on is unique.  From systems, to people, to process.  We pride ourselves in our ability to adapt our expertise to best meet our client’s individual requirements.  That’s why we also look for ways to meet face to face, or provide educational opportunities where ideas can be exchanged.  Please join us for the events below, invite us to your facility to chat when we are in town, or call us for a conversation.  480-346-7011

We hope to see you in 2017:

WEBINAR:

Next Webinar is scheduled for:  Tuesday October 24th – IQ, OQ, PQ – the 3 Pillars of Validation. Read More

Presenter: Suzanne H. Butch, Michigan Medicine, Department of Pathology

TRAVEL:

Detroit, MI – September 19th-22nd

Minneapolis, MN – September 27th-29th

San Diego, CA – October 7th-10th

Robin will be on the road checking in on current projects and visiting clients, if you are in the area and would like to set up a quick visit (or long meeting) please call us at 480-346-7011 or email Robin directly at rnozick@bcsolutionsrfn.com

CONFERENCES:

Michigan Association of Blood Banks – 63rd Annual Scientific Meeting

Livonia, MI –  September 20th-21st

Minnesota Association of Blood Banks – Annual Fall Conference

Minneapolis, MN – September 28th

AABB Annual Meeting

San Diego, CA – October 7th-10th

WEBINAR: “How to Defend your Validation during an Audit or Inspection”

Join us Wednesday June 7th at 1:00 pm EST

Robin Nozick, MT(ASCP) will present

What is Validation? Why is Validation Important? What Must be Validated?
Validation Guidelines  and Documentation needed to prove you’re in control
How to use Validation documentation. What you are trying to prove
What NOT to do.

Learn more by Registering HERE

WEBINAR: Testing vs. Validation

WEBINAR – Wednesday March 1st, 1:00pm EST

BC Solutions, Robin Nozick, MT(ASCP) discusses the difference between Testing and Validation of your Blood Establishment Computer System

What are the keys to maintaining a quality blood bank computer system? Testing and Validation.

Ever wonder what the difference is?  Why both are important?  What is required in order to maintain patient safety and compliance?

This presentation is geared towards explaining the unique requirements of blood bank computer systems.  It is intended to provide valuable information to staff using the system, and explain to those outside the blood bank why compliance is just as important as functionality.

Join Robin on March 1st at 1:00 pm EST for a presentation on this topic and chance to ask your questions.

REGISTER HERE

7 Phases for Successful Epic Beaker Project Planning

7 Phases for Successful Epic Beaker Project Planning

Spring has arrived and for many laboratories that means planning is underway for new LIS projects. If a roll out of a new LIS system is something your team is tackling, here is an outline of 7 project phases our Beaker certified staff of licensed Medical Technologists (MT) believe to be critical parts of a successful plan.  Following all the steps and phases will help you achieve your goal, ensure the needs of your lab are met, and ensure patient safety.

1: Planning – Application Coordinator and Application Manager have onsite visit from Epic team to evaluate the lab department.

Key points: Make sure all software and technical aspects of the lab are included:  Blood Bank, Anatomic Pathology, Laboratory Automation System, and Analyzer Instruments.

2: Installation – Shell System is installed as a Basic Foundation System including build of all lab tests.

Key point: Your lab team can provide a complete list of all order codes and tests available, including all reference lab tests.  This will help you to avoid delays and manually needing to build them later on.

3: Validation – Usually a 3 month time period consisting of site visits to go through lab workflow and determine customization requirements.

Key point:  Ensure Subject Matter Experts (SME) from each department are included for decision making. 

ü  Clerical/Billing

ü  Chemistry

ü  Specimen Processing

ü  Hematology

ü  Microbiology

ü  Blood Bank

ü  Urinalysis

ü  Pathology

 4: BuildBeaker Build occurs in a 3-4 month period concurrent with all other system builds.

Key Point: Many detailed build items occur during this phase.  Some items will be completed by IT personnel and other by laboratory assigned resources.  Experience and clinical knowledge are critical at this step.  Include your Beaker Certified MT or MLT in all aspects of the build, their clinical knowledge is invaluable to completing a full lab build and have it done right prior to the MRT testing period. 

·   Order Codes and Test Codes – Only the initial build is done via export/import functionality so be sure to assign each department SME their section to validate.

§  Facility Structure Build – The full lab and department outline will be detailed here. Include your specimen routing logic, auto cancel rule, and worklists for bench development.

§  Instruments – All analyzer setup occurs here and mapping may be completed by an IT resource, but a MT or MLT should review and sign-off on all data.  Laboratory staff should determine if processing rules will be written in the middleware selected or built in the application.

§  QC Build – A Unity Real Time external product or Beaker internal QC functions can be used for this build, but a department SME should work to develop the scheduled QC runs and alerts within system.

§  Security Build (outside Epic Beaker Module) –Having a certified resource assigned to build all lab users, allows control as to which lab facilities your end users will have access to.

§  Charge Build (outside Epic Beaker Module) – Laboratory build of CPT per order code or result code. Be sure to include a billing specialist to complete this build.  (BCS has developed a detailed billing testing plan that can be incorporated in your system validation to monitor accuracy.)

§  Patient Reports & Labels – Extra time and attention should be dedicated to make sure all CLIA and CAP reporting features are included for proper specimen or patient identification prior to reporting. 

§  Reference Lab Interface – Completed primarily by using translation tables which may be managed by the IT department. Again, include your specimen processing specialist for review and sign off of actual naming mapping and specimen mapping.

§  Custom Management Report Writing – This can be a very technical skill but laboratory personal need to provide the guidance on what they need to capture. 

§  Outreach EMR Interfaces – All outreach systems need to be validated against the new LIS Order and Test build to ensure translation tables are built with the new codes.

5: Testing (Mapped Record Testing) – Internal MRT process within Beaker. Each Order code is ordered and downloaded to the analyzers. Review results returned to ensure each posts to the representative result code. Include MRT to Reference Lab interface and EMR Interfaces.

Key Point:  MRT testing does not cover all CAP mandated checks to ensure laboratory results are complete and compliant.   Work with your project manager to add extra steps in your project plan that check for the following CAP regulations:

ü  Patient Name & Unique Identifier

ü  Name & Address of Testing Lab

ü  Name of Test Performed

ü  Test Report Date

ü  Physician of Record or Ordering Person

ü  Test Results Including Units & Interpretation (if applicable)

*If applicable/appropriate: Specimen Source, Specimen Comments, Date/Time of Specimen Collection, Time of Release of Report, Reference Ranges

6: Training – Workflows are developed by the Instructional Designer to train internal staff.

Key Point:  Include audit tracking to ensure all staff completes training and are signed off as compliant. Strong SOPs will help ensure processes are followed, and new personnel are trained properly.

7: Data Conversion – At this point, your old LIS is able to be exported and imported to Beaker for reference.  There is no limit to the amount of data that can be imported.

Key Point:  Have MT involved in linking each test/result from the old system to the new Beaker code.

After completing these 7 project phases, it’s time to take a deep breath and realize that your lab has gone live with Epic. Congratulations!  Our team has worked through these phases numerous times with Epic and Beaker, as well as with Epic and other Laboratory Systems, having seen firsthand how good planning and qualified resources can impact not only the build, but reduce the risk of retests and lost revenue. Carefully executing these 7 phases will help your new system work for your lab and your patients. Please call us for more information or help with any part of your project.  We’d love to help!

(480) 346-7011   www.bcsolutionsrfn.com

Healthcare Information Technology

Anyone that is involved in the health care industry is aware that there are many regulations in place by the FDA, HCFA (HIPAA), CAP, JCACHO, AABB, ISBT and other regulatory organizations that health care organizations must comply with. One of the major challenges is ensuring that the software being used is also in compliance with regulations.  It’s safe to say that typical I.T. companies aren’t aware of the software elements that need to be in place for compliance.

BC Solutions specializes in healthcare information technology, particularly blood banks and donation centers.  We offer many services such as consulting, data migration, unit testing services, blood bank validation and project management.  We can install or convert your laboratory software with a complete system that maximizes efficiency to save you time and provide quicker results.

Please visit our home page for more information about our company.