Ask the Expert: Waived Testing Changes, Inadequate Lab Space, Lab Record Storage

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Ask the Expert

Barry Craig


I keep hearing different rumors about Waived testing and changes that may be coming. What have you heard?

Ah, the rumor mill. The fastest way to transmit rumors is not broadband or paper, it is voice.

Here is what I know. Waived testing has snowballed into a monstrous industry. When this happens, government regulation is never far behind. Some of the ideas for changes that are being considered:

1. Requiring Proficiency Testing for Waived tests – This I do not necessarily think is a bad idea. Twice a year you would receive specimens that mimic patient specimens. You would run the tests in the same manner as you run your patients, then mark an answer sheet and mail it back in. You would be graded on your performance since the specimens have been doctored to produce known results. These tests measure not only the test method, but the employee running the test. This idea is being considered but is receiving a lot of push back from the testing industry.

2. Requiring personnel standards for training and competency – This would require written documentation of training to perform the test and then periodic competency evaluations to insure continued competency in performing the testing. By the way, #1 can be used as part of the competency evaluation. I believe this being added as a requirement is likely to happen in the future.

3. Manufacturers being required to take a stricter stance on Quality Control requirements – The only requirements for Quality Control under CLIA for Waived testing are that you follow the manufacturer’s guidelines. These guidelines are sometimes vague and do not use definitive terms. They say things like “suggest” and “recommend” when it comes to QC, instead of “required”. I believe this being added as a requirement is likely to happen in the future as well.

I feel the lab space we use in our office is inadequate. We have almost no room to process specimens and it gets very hot in there. I have tried to talk to the doc about it but it falls on deaf ears. Any thoughts or suggestions?

Traditionally the lab sometimes ends up as an afterthought. This is true in physician offices all the way up to large healthcare systems. But maintaining adequate space and environment is part of the CLIA regulations and is also part of all other accreditation agencies regulations as well.

The Federal Register says:

 493.1252Standard: Test systems, equipment, instruments, reagents, materials, and supplies.(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under § 493.1253.(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following:(1) Water quality.(2) Temperature.(3) Humidity.

This means that the environmental conditions must be adequate to meet the manufactures requirement s for storage and use. If the manufacture says to store the kits at 12-24C, then this must be met.

Also, under Lab Director Responsibilities:

As laboratory director, you must ensure that:

• testing systems in the laboratory provide quality services in all aspects of test performance, i.e., the preanalytic, analytic, and postanalytic phases of testing and are appropriate for your patient population;

  • physical and environmental conditions of the laboratory are adequate and appropriate for the testing performed;

• the environment for employees is safe from physical, chemical, and biological hazards and safety and biohazard requirements are followed;

If you do have room to process your specimens, then the above statements are not being met. I hope these regulations will help get you out of the broom closet.

How long do I have to store my lab records? We have boxes and boxes of stuff going back years!

For CLIA purposes, everything the lab produces must be stored, and retrievable, two years. This includes:

Test requests, test reports, QA records, QC records, maintenance and temperature logs, personnel records, validation records, policies and procedures. Validation records and procedure manuals for instruments should be kept for the life of the instrument.

If your facility has transfusion services or cytology/histology, the requirement for the storage of these records is much longer.

Funny bit:

I was watching a sci-fi movie the other day and noticed something hilarious. The “laboratory” people were supposed to be running DNA tests on an alien specimen. They were using a urine dipstick reader found in most doctors’ offices. I laughed till I cried. My wife wanted to know what was so funny and I told her they were checking the alien for a urinary tract infection.

As a parting thought, I noticed on the television show “House” that, quite often, the doctors went to both the lab and x-ray areas and ran their own testing. Wow! I bet you wish that would catch on…