ALO Laboratory Consulting Group, LLC

02/11/2020

MEANINGFUL COMPETENCY

Competency is an activity to monitor and document that testing personnel reporting patient results are properly trained and maintain an acceptable level of competency

Most proficiency testing problems can be traced back to improper competency assessment

Competency is just not a check in the box paperwork task, but meaningful competency means monitoring and properly documenting that testing personnel are competent in all phases of testing

Competency is required for waived, moderate and high complexity testing. Competency is also required for (PPM) Provider Performed Microscopy if testing is performed by mid-level practitioners such as Nurse Practitioners or Physician Assistants

It is also important that competency assessment is performed by competent individuals. Office Managers or Nursing Supervisors who do not perform lab tests cannot be the reviewer of competency assessment

The Lab Director, Technical Consultant or Technical Supervisor are qualified to assess competency

Have questions about competency?
Contact ALO Laboratory Consulting Group!

888-ALO-LAB-1
888-256-5221
[email protected]

01/17/2020

Yesterday January 15th, 2020 Abbott sent an urgent notification to US customers currently using the i-Stat point of care analyzer regarding the Chem 8 + and CG4 + cartridges. Abbott modified the original white Chem 8 + and CG4+ cartridges, and introduced the blue Chem 8 + and CG4 + cartridges without obtaining FDA waived and non-waived clearance for the modified cartridges.

What does this mean for you if you are a physician office laboratory or free standing emergency room/facility using these i-Stat chemistry cartridges onsite?

Ø The FDA informed Abbott that these two modified cartridges – Chem 8 + and CG4 + are not approved for waived and non-waived testing

Ø That automatically converts these two cartridges to highly complex, laboratory developed tests (LDT)

Ø If your facility choose to continue using the two affected i-Stat cartridges, you are now required to perform full clinical and analytical validation studies

Ø All your test results for the two cartridges should also include a disclaimer of no evidence of FDA approval

Ø Your testing personnel must also meet the CLIA requirements for highly complexity testing

Ø If you currently do not perform QC on a daily basis for the Chem 8 + and CG 4+ cartridges, you must develop an IQCP plan immediately

Ø Other FDA approved waived and non-waived alternatives are out there, and you will have to do your own cost-benefit analysis and decide the best route for your facility if you are affected

At ALO Laboratory Consulting Group, LLC, we believe that we are in this together! We are here to provide guidance and support so that you can stay compliant while also improving quality and efficiency by providing interrupted onsite lab services.

Focus on your patients, as we zoom in on the Lab!

ALO Laboratory Consulting Group, llc

T: 888-ALOLAB-1
888-256-5221
[email protected]

01/11/2020

We provide comprehensive solutions for a variety of clinical laboratory needs to help providers efficiently perform labs in their offices to improve patient experience and profitability.

Our team of multiskilled Medical Laboratory Scientists will work with you and devise a solution tailored to your office laboratory needs.

01/11/2020