Ask the Expert: Questions From Physician Office Laboratories

I am having trouble contacting the state CLIA office for where I live. Is there a list or something with this info?

Yes there is. Here is the link to the CLIA contact database. It lists all the state agencies for CLIA and their contact info including addresses, phone numbers and emails.

Regulations-and-Guidance

Who is required to review and sign off on the controls, calibrations, etc. that are produced by the lab? If the tech that runs the instrument signs off, is that sufficient?

For all non-waived labs, it is required to have someone listed as either technical consultant (moderate complexity) or technical supervisor and general supervisor (high complexity). These positions should review all documentation produced by the lab. If the Lab Director fills more than one role and also serves in one of these roles, then they must review and sign off on these records.

The laboratory inspector cited us for not having a "traceable" thermometer for our refrigerator. What does this mean?

Traceable refers to NIST traceable. This means the thermometer is certified to be accurate and comes with a certificate of accuracy from the National Institute of Standards and Technology (NIST). The thermometer will have an expiration date on the back. After the date listed, the thermometer is no longer considered accurate to NIST standards and must be sent in for recertification.
Check the POR magazine website to see if these are available through one of their advertisers.

I just looked on the wall in the lab and our Certificate of Waiver has expired! What do we do now? Are we in trouble?

First, the government goon squad is not going to break down your door and start shooting (unless it's related to tax evasion, then the IRS will break the door down).

Stop testing immediately. You cannot test without a valid license. Contact your state CLIA office (see the link above) and find out if they can resend your payment coupon or if you will need to apply again from scratch. Regardless of what they say, NO TESTING CAN BE PERFORMED until you pay for and receive your new license. Also, any testing performed while the certificate was expired is subject to having the reimbursement taken back.

We have had a rash of bad needles lately from a manufacturer we normally do not order from. These are snapping off at the hub when we use them. I am afraid one of patients is going to get hurt. What steps do I take to report this problem?

The FDA has a program called MedWatch 3500, which a reporting mechanism for any medical device that can cause injury or death to a patient.

Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for:

  • Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
  • Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
  • Medical devices (including in vitro diagnostic products)
  • Combination products
  • Special nutritional products (dietary supplements, infant formulas, and medical foods)
  • Cosmetics
  • Foods/beverages (including reports of serious allergic reactions)

Just Google "Medwatch 3500" and all the reporting forms and instructions will be there.

 

Barry Craig

 

Expert on physician office laboratories and diagnostic equipment

Barry works almost exclusively with POLs and understands the needs and challenges they face. With more than 20 years of lab consulting experience, his company works with office lab start-ups, inspection follow-ups, and help with the CLIA, COLA and JCAHO regulatory issues offices face daily. He offers a unique insight and customer focused approach to the lab and its solutions. In his current role as President of Laboratory Consulting, LLC, Barry is leading the way for physician's offices to develop their in-house labs as a place to obtain fast, accurate results and maintain a healthy profit using the latest technology available.

Being in touch with the POL community nationwide his company has a unique insight into the problems and questions that arise from the operation of a POL.

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