Pain Practice Laboratory Made Simple

Welcome to the second in our series of articles focusing on Pain Management Practices. In this article we will address the topic of laboratory testing, specifically Urine Drug Screening in Pain Management. Many pain practices utilize Urine Drug Screening Point of Care Rapid Cups as there only form of laboratory testing. In many practices, those samples are then forwarded to a reference for additional testing.

Point of Care Rapid Drug Screen cups utilize Flow Through Technology which basically means that the target (analyte being tested for) is attached to a membrane inside the rapid cup.  The sample, in this case your patients urine, flows across the test membrane and if the target analyte is present in the sample it attaches to the membrane and a visual change occurs allowing the test results to be read visually without any form of reader or equipment. While quick and easy, there are many ways for errors to occur.   All product inserts include storage guidelines, specimen volume requirements and time frames which must be adhered to for the test results to be valid. As with any point of care test the potential for human factor errors cannot be ignored. Additionally, not all point of care rapid drug screening cups are CLIA Waived. 

I reviewed product inserts and information provided by 25 manufactures of Rapid Testing Cups and I was disappointed to find that the documented Sensitivity and Specificity rates for the Point of Care cups does not compare to the other Point of Care testing methods currently used in Clinical Laboratory Medicine. While you will never get 100 % Sensitivity and Specificity, you want to utilize a method that gets as close as possible to reduce the amount of false results. The Sensitivity rate ranged from 90% to 98 % and the Specificity rate ranged from 85% to 96% depending on the manufacturer.  All manufactures also list a number of potential interfering factors that may affect the test results. I encourage you to check the product insert for the rapid cups you are currently utilizing in your practice. All point of care rapid cups yield a qualitative result, reporting as either positive or negative for the drug class or metabolite tested. Due to yielding a qualitative result, it is recommended that additional testing be performed.  Additional testing may be quantitative utilizing chemistry instrumentation and enzyme immunoassay methods or liquid or gas chromatography methodology.

The method of additional testing should be your decision, not the reference laboratories.

Setting Up a POL

Point of care rapid drug screen cups are not your only option. I would like you to consider other methods for laboratory testing in your office by setting up a Physician Office Laboratory (POL).

Setting up a POL is not as difficult as your reference laboratory account managers would like you to believe. Most reference laboratory representatives will try to discourage you from setting up a laboratory in your office. This is because they understand that if you perform testing in your office, the amount of testing you send to them will be reduced. You will want to form a relationship with a reference laboratory that works with you to support and complements your in house testing.

Investing in a POL is a good patient care decision and a good financial practice decision.  Starting a POL should be done only after you review everything involved including: costs of start up and operation versus the potential benefit to your patients, and the allowable reimbursement obtained from laboratory testing.

The entire process may take several months, so please be patient. Briefly what is involved after you make the decision to set up your POL is:

  • Application to CLIA to upgrade certificate
  • Application to state for licensure, if applicable
  • Choose space in your office for laboratory
  • Choose instrumentation
  • Instrumentation installation, validation and operator training
  • Preparation of Laboratory Manuals
  • Enrollment in Proficiency Testing Services
  • CLIA or state survey, prior to initiation of testing

Each of these items is discussed in more detail below.

Applications to CLIA and State Licensure

For the sake of discussion I will assume you are doing rapid drug screen cups in your office, which means you have a CLIA certificate of Waiver.  In order to add a physician office laboratory to your practice you must obtain a CLIA certificate of Compliance or Accreditation. This will require completion of and submission of a CLIA application to upgrade your certificate as well as payment of fees based on your anticipated number of tests performed. Contact your state Department of Health or Department of Business/Professional Regulation to determine if your state requires Laboratories and laboratory personnel to be licensed. This will vary from state to state. (If your state requires laboratory licensure this will require completion of and submission of the state application along with any applicable fees.)  This is in addition to the CLIA application and fees. In order to perform Urine Drug Screen testing using a chemistry analyzer which is classified by CLIA as" Highly Complex testing", you will have to have a CLIA qualified Laboratory Director and CLIA qualified testing personnel.  Check out this website for CLIA requirements:wwwn.cdc.gov/clia/regs/toc.aspx

 

Office Space

Determine where in your office you would like to set up your laboratory.  The area should have space for a counter for the chemistry analyzer and computer, unless your practice is large enough to support a floor model analyzer.  A sink, refrigerator for storing testing reagents and samples, and a work area for staff to prepare samples for testing are also required.  The area should not be carpeted and any windows should have blinds, otherwise controlling the room temperature for instrument operation may be a challenge.

Instrumentation

Contact laboratory vendors a>d equipment manufacturers for information on instrumentation options. They will need an estimate of the number of samples you run per week or month. Make sure when you get proposals from them that they reflect the numbers provided, not inflated numbers to make the proposal more attractive to you with regard to potential earnings. Talk to your colleagues that are already operating an office laboratory or contact a laboratory consultant for assistance.  You don't have to do this alone, there are an abundance of resources to help you an informed decision, use them! Choose a laboratory vendor or manufacturer that has experience in the urine drug screen testing market and who will put your needs ahead of their desire to sell you an instrument.

Compare the costs and services being offered, paying close attention to the cost per reportable test. That means the cost of a patient test that you can bill for, not the cost of calibration and quality control testing.  If a vendor won't tell you the cost per test, only the cost per kit or box of reagent, you do not want to deal with them.

Evaluate the options of purchase, lease and reagent rental for laboratory equipment. Many vendors and manufacturers offer consultation services to help you get started or can refer you to a laboratory consultant if you desire. Take advantage of the consultation services in order to insure that you are in compliance with federal (CLIA) and state guidelines.  This will make starting your POL "painless".

Once your instrument choice is made, arrangements will be made for delivery, installation and validation of the test menu you have chosen to run on your instrument. Your laboratory staff will be trained on operation of the instrument and performance of drug screen testing. Laboratory manuals to include Policies, Procedures, and Quality Assurance will need to be written (this is where those consultant services pay off) and reviewed by the laboratory director and laboratory staff.

Proficiency Testing and CLIA/State Survey

The laboratory must enroll in Proficiency testing in order to be in compliance with the CLIA guidelines.  Once all of these are complete you are ready for your survey. After the survey is complete you will be notified when you can begin testing.

While this certainly may sound complicated and somewhat overwhelming, it doesn't have to be. Utilize the many resources available to make an informed decision, and I'm sure you will quickly see the benefits of a POL far outweigh the efforts required to get started. In the next article I will discuss reimbursement associated with Urine Drug Screening. (One of the many aforementioned benefits)

Wishing you a Happy Holiday Season and a prosperous New Year!