Technical Only Flow

Technical Only Flow, or use of the TC/PC split, sometimes referred to as “Virtual Flow” was introduced to the market, over 10 years ago, in January of 2002.

LabPerfect, having had experience introducing this technology to the market, can leverage this technology for the benefit of organizations and medical practices looking to provide these services to their clients.

  • Establishing Validated TC Flow Cytometry Departments including:
    • Validation Plan
    • Obtaining instrumentation, reagents and supplies
    • Panel Design
    • Analysis, interpretation development, report generation and sales and marketing support
  • Provision of qualified Medical/Professional Interpretation, if the Professional Component portion is considered or required

 

Standardization of Clinical Flow Cytometry

Standardization of Clinical Flow Cytometry – Euroflow, vs Current State of the Art

Issues and Concerns:  Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called “home brew” assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS – Part I – Rationale and aims. VC 2013 International Clinical Cytometry Society

Davis, et al, Cytometry Part B (Clinical Cytometry) 84B:282–285 (2013)

 

This dedicated issue of  Cytometry Part B, contains valuable information that the regulating bodies will consider on a go-forward basis, in their decisions as how this important field will be regulated and possible changed.

 

Stay tuned to further updated on www.labperfect.net

CAP Checklists

An Analysis of compliance requirements and issues.

  • Requirement  –  Positive Control for L/L markers
  • Issue: Rarely encountered antigens are difficult to readily find.

Resolution:  Network with labs and organizations to share source materials,

 

Comments:

Jobs – Flow Cytometry Technologists

Flow Cytometry Technologists

Task

  1. Setup, Run Flow Cytometry experiments in a clinical laboratory setting.

Skills Needed

  1. Experienced in Flow Cytometry
  2. Experienced in clinical laboratory operations
  3. Experienced in immuno-histochemistry
  4. Experience working with start-up labs desired
  5. Some travel may be required

Call for a quick interview (714) 329 – 9938 or email Michael.Schwartz@LabPerfect . net

 

Flow Cytometry Validation Protocol

The first document that should be established, when setting up a flow cytometry laboratory is a Validation Protocol.  This will be the master document to follow when preparing to test samples using a flow cytometer.

Components of Flow Cytometry QC should include:

1.  Instrument Control

a: Optical alignment (Daily)

b. Standardized optimal detector voltages (Daily)

c. Sensitivity and linearity (Initially and monthly, thereafter)

d. Compensation (Daily but can be validated and shown to be stable over a one week period)

e. Correlation studies, if applicable.

2.  Antibody Control

a.  Must monitor and verify that fluorescence is consistent, in a normal sample and on a day to day basis

3.  Reagent Control

a.  Must also monitor and parallel all reagents used in testing.

4.  Procedural control – Monitors the sample preparation methods.

5. Specimen integrity verifications – This is a requirement that all samples be evaluated for suitability for analysis.  If the viability is low it is necessary to comment on it’s suitability for analysis.

6.  Patient QC  – Prior to reporting, the identity of the results needs to be able to be verified and tracked.

There are many details of all of the reagents and QC materials used in all of these areas of testing for quality, but suffice it to say that in order to validate flow cytometric analysis in your lab you must:

 

Say what you will do:  Validation Protocol,

 

and more importantly:

Do What You Say

 

The “Keep It Simple Stupid” – (KISS) Principal

“Keep it Simple Stupid!”  The medical field has been swept up in a revolution of scientific discovery.  With the advent of unlocking the secrets of life, encoded within our DNA, the link between research and clinical practice has been skewed.  Sales hype and the perceived potential for profits, differentiation  and marketing claims make untested medical breakthroughs part of the sales professionals pitch.  “The Shameful State of Our Hospitals”  (http://www.beckershospitalreview.com/hospital-management-administration/chuck-lauer-keep-it-simple.html) written by Chuck Lauer, regarding the need to get back to basics site many instances where getting back to basics can vastly improve the state of healthcare.  I was told of the KISS principle early on in my career, and I’ve always focused on accomplishing the “Task at Hand”.  As technology and medical science advances, it is increasingly hard to maintain that focus, but if you break down complicated tasks, into “bite sized” pieces, it’s easier to make step-wise progress to your end goal.

Whether meeting quota’s, validating tests, products and services, maintaining organizational integrity or C-suite titles are motivating factors in peoples aspirations, the bottom line, as it relates to healthcare, is the patient.  Without exception, the importance of the patient is always the ultimate focus of the mission statements of all the companies I’ve ever been involved in.  Profits are certainly important, as this is the mothers milk of success and the driving force in order to keep moving forward.  When a product or service goes to the bottom line, “the patient”, it makes it all worthwhile, and profits follow.

All that said, the discovery of new genes that govern biological processes, and our ability to investigate these, do hold the potential of improving the lives for those afflicted with specific problems.  The FDA as well as our elected officials in Washington, have the sacred task of regulating what is, and is not worth moving forward.  Whether it’s FDA approval or government and business subsidy and sponsorship, moving these technologies forward should be dependent on how these discoveries advance the ultimate cause; the patient.

Personalized medicine has been a buzzword that has been used to represent the potential of improved outcomes.  To corporate executives and business leaders it actually represents increased sales and profits.  In a world of “out of control” healthcare costs, we all need to get back to basics and keep it simple. The pediatrician who treated our children used to always say, “my kids had this, and I did, so and so…”, and I was upset that she wasn’t being scientific, but in retrospect, our kids turned out just fine, and looking back, her approach to the practice of medicine was simple and effective.  In large part, that’s what we, in the medical community, need to get back to.

Focus on specific details of everyday activities and help move projects forward.  Focus and succeed!!!! And Keep it Simple Stupid.

 

Inventory and Ordering:

www.Labperfect.net

Inventory and Ordering:

The most common inventory/ordering system for startups and small laboratory businesses involve some type of Microsoft Excel spreadsheet application.  Often, these spreadsheets contain lookups and internal programming that makes tracking and ordering inventory more convenient.  A typical example of an Excel spreadsheet may look something like:

labperfect image001

Where you list your purchase orders, per vendor, with a general item description, on a tab labeled P.O. Log.

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Various tabs in the spreadsheet can have lookups, where you fill in one item, say a part number for example, and vendor, vendor contact, item price, item description, and more, can be automatically filled in:

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This is an example of a purchase order that can be quickly and easily filled out by just adding in your part numbers for your supplies and reagents.  This then can be saved and emailed to the purchasing authority at your company.  The Vendor Name, Address, Phone, Email Address, Contact Name, Fax No., Account # and Item Description will instantly be filled in by looking into other spreadsheet tabs (Vendors List, Running Lists of supplies and reagents, a “Supplies” sheet, and more, to find the appropriate information.

This makes ordering and tracking for the individual, fairly painless, unless you’d like other people in the company, who may require similar reagents, supplies and equipment, to access the same information, instead of re-creating the process, and needlessly duplicating effort, supplies and reagents.

To increase efficiencies and economies of scale, you’d like to have the more people participating in the ordering process.  By doing so, you’d get better pricing, if you’re going to use certain materials, in a certain period of time.  By tracking usage, you could order the “right” quantity and save, even if ordering a smaller amount costs more, you’d save due to the avoidance of spoilage due to reagent or supply expiration.

Inventory/ordering/supply level consolidation enables:

  1. Less reagent spoilage
  2. Better pricing
  3. Item/equipment standardization (where possible) – allowing a failsafe: Sharing of supplies between departments.
  4. Allows a continuation of services avoiding the cost of operational failure.
  5.  Lower Overall Costs

One must consider critical supply disruptions and reagent expirations – as the cost of abrupt production outages could have catastrophic effects on a small fledgling company.

In addition, by shopping different catalogs, for the same items, you’d generate supplier competition and competitive bidding for your business.

One such software application that provides this type of service can be found at:  www.quartzy.com

Quartzy.com is an online, cloud based solution to your Inventory/Ordering needs.

  1. Having a purchasing agent in charge of keeping track of expenditures, the approval process can be funneled through that one person.Also, when ordering, the various departments of the lab can see what has been ordered, where it is being stored, and find out if the supply that is kept on-hand can be shared between the different departments.
  2. Easy setup of inventory and ordering: By adding an item to your inventory:labperfect image007
    You can easity add single items, or you can add many items by cutting and pasting the appropriate fields in your spread sheet directly into Quartzy by uploading a “Quartzy” generated spread sheet:
    labperfect image009
  3. An example of such a spread sheet might look like this:labperfect image011 
  4. One can edit and customize the fields to accommodate their Excel spread sheet by creating  or choosing the appropriate headers on the window following calling for Excel spreadsheet:
    labperfect image013
  5. This would allow you to cut and paste from existing Excel spreadsheets directly into Quartzy.It is important though, to always paste “text” or Value fields into the Quartzy generated spreadsheets, as it doesn’t recognize any special formatting that may be present in the Inventory spreadsheet.  You can paste “Values or Text” by using the paste feature found in Microsoft Excel:

 

 

LIS

Laboratory Information Systems are critical to successful laboratory operations.  Critical features of an LIS would be:

  • Simple yet comprehensive – ease of use and instant applicability to add benefit to the laboratory is essential.
  • A cloud based LIS solution allows busy, on the go, clients that ability to access their vital data, anywhere, anytime.
  • HIPPA compliance and security – With increased scrutiny being put on protected health information (PHI), a system that conforms to all regulations and protections from the unintended viewing of patient results, is an absolute necessity.

Evaluation of the performing sales reps, and where new business is being developed is a beneficial element of an LIS system, to enable rapid growth and servicing of new and existing clients.

  • Easy to read auto-generated charts and graphs, that communicate large amounts of summarized data, in an instant, is a plus.

Technical Support – Excellent implementation and ongoing support

Seamless Integration to all associated software applications

 

Further evaluations of the specific features of various systems to come…

Managing your Standard Operating Procedures (SOP)

Managing your Standard Operating Procedures is easy, once you have the template and framework setup. All procedures stem from the Mission Statement.  From the mission statement stems the overall policy and procedures to establish quality.  This is an important aspect of overall continuous quality improvement, as well.  All SOP’s should reflect current practice, and revisiting these procedures, when making changes to the procedure, is an important part of documented change control to reflect the current practices at any point in the clinical operation of a laboratory.  Change approval is usually made by the laboratory’s Medical Director.

MISSION STATEMENT:  This statement should reflect the overall purpose of the business.  Careful thought should be given when formulating a Mission Statement, as all other policies and procedures stem from this goal.

Policies: It is imperative that the executive management team formulate the Mission Statement and support the policies that support the overall mission of the company.

Procedures:  Procedures support the policies and overall goal of the company by providing “How To” instructions on carrying out the various functions of the laboratory.

An efficient management of documents is necessary, as the amount of data required to start, maintain and improve a laboratory operation is immense.

Managing your Lab inventory / supplies