A Better Lab Now

Monday, April 1, 2024

Coming Soon

Creating a Project for your Staff and Mentorship

Organization with PARA

Closed Channel Development for the Cobas Pro

Project Board- Studies

Assay Conversion- The Infinity Connection

Calculations Review for CAP Inspection

Project Board- Quality Control

Are You Ready to Teach with TikTok?

Project Board- Procedures

Project Board- CAP

Project Board- IT

Project Board- Validations Plans & Sign Off

Project Board- Communication

Body Fluid Analysis: Are You Ready for Inspection?

A guide for Body Fluid validation is available from CLSI. C49 Analysis of Body Fluids in Clinical Chemistry should be reviewed, and you should review your laboratory's validations for possible weakness when a CAP inspector asks "Do you have any LDTs? or "Are you using any a applications off-label?", or just "Are you performing body fluid testing?"

Using a spreadsheet here are the suggested validations from the CLSI document and a place for what we have done and place for my medical director to detail if we need additional validation.

I provide this for you, but with the caveat that it does not replace the need for you to obtain the CLSI document and review it yourself. It will be well worth your effort.

Key Point	Current Processes	Follow Up Actions
Definitions of Fluids: Includes names of processes of removal (BF—centesis) Pericardial Peritoneal- aka Ascitic fluid Pleural
Proper instruction provided for collection and transport is provided to user; being part of validation for body fluid testing.
Laboratory needs to evaluate clinical requests and inform which tests will not be provided.
Pleural Fluid for pH should be collected and tested as blood gas sample.
Specimen processing: pretreatment, specimen viscosity issues and various techniques: dilution, freeze-thaw cycles, hyaluronidase. These processes should be included in validation plan.
Measurement Procedure Selection based on expected measuring range need to consider appropriate analyzer application [and reagent choice].
Measurement Procedure Validation- Accuracy: comparative reference measurement, spiked studies, 40 samples.
Measurement Procedure Validation- Spiked Recovery: three specimens each spiked three times with comparison of observed vs. expected results.
Measurement Procedure Validation- Mixing Studies: 3 pair specimen sets.
Measurement Procedure Validation- Dilution Recovery: three specimens diluted at three different concentrations.
Measurement Procedure Validation- Precision: 2 specimens near medical decision points, 5 reps for 5 days.
Measurement Procedure Validation- Detection Capability: prepare four diluted samples using specimen that is above the LLoQ and blank sample.
Measurement Procedure Validation- Linearity, AMR: 7 – 9 samples prepared by mixing, spiking and dilution prepared to demonstrate linearity over the proposed measuring range.
Measurement Procedure Validation- Reference Interval and Medical Decision Limits: Laboratory should provide guidance in interpreting results even if intervals cannot be defined.
Measurement Procedure Validation- Endogenous Interference Testing: due to the possibility that manufacturer tested interferences may exist in higher concentrations in body fluids the laboratory should access if these studies are directly transferable and perform evaluations when appropriate.
Measurement Procedure Validation- Sample Processing: perform paired difference protocol on specimens for various sample processing techniques such as those to reduce sample viscosity.
Measurement Procedure Validation- Stability: laboratory should establish stability as it relates to body fluids as possibly different than blood samples.
Ongoing Quality Assurance- Quality Control Selection: Controls used for serum assays are usually sufficient, taking note that levels should be appropriate for expected values in body fluids if different.
Ongoing Quality Assurance- New Reagent Validation: inclusion of body fluids for correlation should be considered; however, if reagent is only used for body fluid then body fluids should be used.
Ongoing Quality Assurance- Biannual Instrument Measurement Comparisons: body fluid specimens should be included.
Ongoing Quality Assurance- Biannual Linearity and AMR Verification: commercially available martials for serum, plasma, urine are acceptable.
Ongoing Quality Assurance- External Quality Assessment: commercially available products for body fluids should be used. When not available, but a serum/ urine is available then an alternate is not required. When neither body fluid or serum/ urine is available then and alternate assessment is required.

Sunday, March 31, 2024

Can a Single Book Enable Your Middle and Senior Laboratory Staff?

Years ago I came across a 1997 edition of a book as a .pdf on the internet. I thought the title a little funny and thus intrigued I read on. Suddenly I was immersed in the first book that actually detailed my job functions as a Chief Laboratory Technologist. Even though it was already a few years old it detailed many processes and functions I had figured out myself or from many different resources. It provided a detail that I found very useful which helped develop my Personal Job Description.

I hope you are also intrigued and read on. After finding this book on Amazon I bought my own copy and then gave away many copies from the 2020 edition to the 2023 edition. I have given this book to Pathology Residents, Chemistry Fellows, my managers, my counter parts in my system's community laboratories, and my Specialists in my own department. The Specialists in my own department I am calling in this context my "middle staff". Can this book enable my middle and senior staff? I say, if I have given away at least 20 copies, then I say emphatically YES IT CAN!

Here are the front and back covers:

Here is the description of the book you will find on Amazon (3/21/24):

How to be the Lab Director of a general hospital lab. Includes tutorials on: how to make a corrective action, requirements for proficiency testing, how to remediate proficiency testing failures, how to make a Plan of Correction (PoC), how to respond to CMS form 2567, how to put a new analyzer into service, how to do validation and verification, how to do quality assurance and root cause analysis, how to write a policy and/or procedure and how to respond to complaints and incident reports involving lab. Includes easy to understand explanations of accuracy, precision, sensitivity, specificity, proficiency testing, correlation, reference range (also called normal values), critical values (also called panic values), Limit of Detection (LoD), Limit of Quantitation (LoQ), ruggedness, robustness, linearity, Analytic Measurement Range (AMR), controls, calibration, false positive, and false negative as applied to the clinical lab and diagnostic lab testing. This book includes information on how to start a new lab, lab planning and budget, how to verify a Laboratory Developed Test (LDT) or "off label" test, qualitative analyzer verification, how to make an Individualized Quality Control Plan (IQCP), how to perform voluntary closure of a laboratory. information on how to helm a hospital lab through a major disaster, and information on Lab Director liability (malpractice) insurance, recommendations on how to validate microbiology organism identification and antibiotic sensitivity testing. The section on Individualized Quality Control Plan (IQCP) has an example IQCP. The 2023 edition includes information on lab testing in the COVID pandemic including SARS-CoV-2 test verification, SARS-CoV-2 specimen handling and pooling, laboratory expansion to accommodate SARS-CoV-2 testing and travel-related COVID testing, and how to reduce and reallocate laboratory resources after COVID test requests decline.

Can this book "enable" your staff? Every time I have given this book there was a wiry smile on the face of the recipient, then their eyes widened when they saw the content. The current price for this concentrated textbook for your laboratory staff is less than $11.00.

Why THIS book? It says "How to be a Lab Director". Your middle and senior laboratory staff have a fundamental job description to SUPPORT their Laboratory Management and Medical Directors. Knowing the responsibilities of these people, and having the technical skills to do so, ENABLES them to do so.

Sunday, March 24, 2024

A Professional Development Program for Your Staff

As a manager of a laboratory you may be considering a strategy of succession for your senior staff.

Or you may be interested in advancing staff with core competencies that would be essential with new instrument acquisition or simply to share the load of complex tasks that befall the senior staff.

I think those are all good reasons to look at the many tasks your lead technologist perform and provide a way to spread this technical knowledge base. Additionally, I think it is imperative to look at this as a way to retain staff by engaging and developing their skill sets.

Looking at the challenges we face in the laboratory it may be only short sighted to look at the training and retention of new or younger staff. We always should be looking for ways to invest in the "middle" staff to advance their "senior" skill sets for readiness of succession, assisting in periodic, large projects and their retention!

How to accomplish this? I look at it as a project, it needs design with specific objectives and due dates, participation by senior staff and the medical director. Even though much of this non-productive work, I think it is important to make this project "institutionalized" into your operational plan.

Starting in 2018 I wrote down all my tasks and projects, what I was best at and what others were best at. The point would be to take our best assets and make more. Your lead techs are probably caught up in the constant scurry to complete tasks that they could not list for you all they do without taking a long moment to think about it. So I took my time and wrote it down and wrote a "shell" around that. The shell is the program with a plan to teach all these skill sets and provide real world practical projects for the trainee to complete. Then, title the project with a, maybe stighlty grand title.

I called mine [insert major chemistry line name] Professional Development Program. When I showed that the vendor they were very excited about it and pledged their resources to assist in the program.

Here is my 2018 draft for you to consider how to adapt to your uses.

XXXXXX Hospital Department of XXXXXX

[Main Chemistry Analyzer] Professional Development Program

Objective:

The objective of the program is to train a tech is all areas that support the operation of the XXXXX analyzers. Presently there are several techs who are very knowledgeable of some of the components of this program, but not all. This program addresses the need for coverage when one person is absent, provides for succession, and helps secure the department during periods of special projects, personnel turnover, and other events. This program will enhance the operations of the shifts where these tech work and the whole department overall. Much of this training has carry over to other instruments in the department which allows additional coverages when needed.

Scope:

The program can handle up to two techs at one time. Techs must have demonstrated commitment, motivation, and desire to complete the program. The two candidates are ideally not from the same shift at the same time. Depending on laboratory resources additional techs can join the program before the current techs complete all the components.

The time commitment is approximately two years to adequately cover the program components, provide time for the tech to perform the tasks and feedback, and make process improvements.

Training and competency will cover lower management, technical, and Informational Technology duties. Each component will have four elements that cover:

· Education (direct and independent training),

· Practical (the component being performed by the tech),

· Experience (the independent actions and feedback of current practices and procedures), and

· Process Improvement (the items the tech has helped to improve in the department).

These sections will be signed by laboratory management as being completed satisfactorily.

Resources:

Individual components of the program will have a lead person identified who has expertise in the tasks for be completed. This person will train the tech and monitor progress. When ready the tech will assume assigned duties and projects to complete the Practical and Experience elements. The Process Improvement element is accomplished as an ongoing project and does not have specific time restraints.

Other resources include specific on-line training modules from Bio-Rad, XXXX, and Med Training. On-site training provided by vendors including Bio-rad and XXXX. It is preferred at least one off-site training occur related to the program components. Additionally, lecture and CE by laboratory personnel to includ residents, fellows and medical directors to supplement the training where indicated.

Outline:

Program Components:

A. Reagent Management

B. Quality Control

C. Quality Indicators

D. New Assay Validation and Implementation

E. Procedure Writing

F. Training

G. Mentoring

H. Competency Assessment

I. Proficiency Testing and Management

J. Maintenance

K. Troubleshooting

L. Instrument Interface

M. IT Tasks and Validations

N. Instrument Manager

O. Water Supply

P. Regulatory

Q. 6 Sigma White Belt Project

Reagent Management

This component encompasses the annual reagent order, individual orders, product receiving, stocking and monitoring of reagent lot changes, expirations, Reagent Bulletins, Package inserts, and procedural changes related to reformulations, conversions and best practices. By the end of this process the tech will be proficient in all areas, and will be able to provide process improvements and cost savings, and independently take action to overt waste, and incorrect result reporting.

A. Education (this section for details of training, resources, and check-off)

B. Practical (this section for details of what the tech will do and duration)