Ask The Expert

 Happy 2009! I hope the New Year finds all of you in good health, rested, and ready to tackle the cold and flu season!

Here is the latest batch of questions I have received

My lab is under CLIA and we were cited for not having a Quality Assessment plan. What is the difference between Quality Control and Quality Assessment?

Quality Control is part of the laboratory’s Quality Assessment program consisting of their proficiency testing program, personnel competency assessments, quality control program, etc.

The laboratory director has the overall responsibility to determine the

laboratory’s QC program. The laboratory must establish the number, type and frequency of testing control materials that monitor the complete analytical process:

The quality control process involves running samples of known value or range of values and comparing the results obtained to the expected values.

Waived testing requires that you follow the manufacturer’s recommendation for frequency and type of QC testing.

Non-waived testing requires at minimum that two levels of external controls be run each day of patient testing. This is a minimum requirement and some tests systems may require more levels of controls to be run or more frequent intervals

Quality Assessment involves measuring and monitoring all parts of the testing process by assessing and reviewing different components of the testing process.

The testing process is divided into three distinct groupings; pre-analytical, analytical, and post-analytical.

Pre-analytical: These are the things that take place before testing begins. Items that could be measured as part of a QA plan include:

• Personnel competency – Are the people performing the tests educationally qualified? Have they been properly trained to perform the test? Have their skills been assessed in the performance of the tests?
• Patient Identification – Are patients identified by two unique identifiers before specimens are collected? Are collection devices labeled with the identifiers and does the specimen stay labeled through all phases of testing?
• Specimen Collection – Is the specimen collected in the proper tube or collection device? Is the patient properly prepared for the tests to be collected such as fasting for a lipid profile?

Analytical: These are the things that take place during the testing procedure. Items that could be measured include:

• Quality control – Have all controls been run and found to be within normal limits before any patients are tested?
• Instrument maintenance – Has the instrument been properly maintained and is it documented to be in working order? Is corrective action is taken and documented when analyzers do not meet performance specifications?
• Reference or normal ranges – Have normal ranges been established that meet the patient population served by your laboratory?

Post-analytic: These are the things that take place after testing has been completed. Items that could be measured include:

• Results reporting – Are results reported to the ordering physician in a timely manner? Is a copy of the results maintained and all instrument printouts maintained for a minimum of two years?
• Results review – Are results reviewed before report to make sure they are clinically relevant and are not erroneous?

We received a renewal bill from CLIA today but our certificate does not expire for six months. Was this in error?

CLIA usually bills for certificate renewal about six months before your certificate expires. PLEASE note that CLIA generates only one renewal bill. They do not send reminders or follow-up letters. Your site really has just one chance to pay the renewal. If your certificate expires and you have not paid for renewal, you must cease testing until your renewal is obtained. The best practice to follow is to call your state CLIA office if you are within three months of your certificates expiration and have not received a renewal notice, and make arrangements for payment. If you have a low quantity of memory cells like I do, mark it on your paper or on-line calendar. You can also contact your state CLIA office and change the contact person for mailings to someone you are sure will recognize the bill and take care of it. Hint: Having the bill sent o the physician director is not always best practice as their mail tends to stack on their desk like an Egyptian pyramid.

What is your take on used equipment? Is it a good buy? Does CLIA care if you purchased it used?

CLIA doesn’t care where you obtain your equipment as long as it functions properly. My personal feeling is that used analyzers and instruments can be a risky proposition.

First, use equipment usually does not have a warranty so if it quits on the second day of use, to bad.

Second, it can be costly to obtain a service contract for used analyzers. I know of a site that purchased a used hematology analyzer and then spent an additional 3500.00 to bring the instrument up to specs before the manufacturer would certify it for a service contract.

Third, it’s used. Do you really want to buy someone else’s problems? Running a physician office lab is stressful enough when things go right so why add to the stress by dealing with the magical, exploding glucose analyzer to your day?

My opinion is to steer clear of used equipment unless you personally know the history of the instrument and who you are purchasing from.