Be prepared for inspections

Aug. 1, 2009

When it is lab-inspection time

From The Lab Guy, Tim Dumas


The inspection process ensures that a lab is following
certain standards so test results used to diagnose and treat patients
are accurate. A two-week notice precedes the majority of lab
inspections, giving time for lab personnel to prepare (and to stress).
Unannounced inspections are an option, so it is best to stay prepared at
all times. Surveyors visit your lab to help you help your
patients, so make your life easier by trying to make their 
job easier. Here are a few tips to assist an inspector with the job:

  • Familiarize lab personnel with the inspection
    process and, more importantly, with what the inspector is looking
    for. CLIA makes this information available at
    If the guidelines are confusing or do not answer your questions,
    call your state CLIA office to ask for assistance. If you are a COLA
    lab, an inspection guide has been given to you.
  • Have necessary procedure manuals, personnel
    folders, QA documents, QC charts, and proficiency-testing results
    separated and organized. To avoid prolonging the process and to
    appear prepared, appoint one person to answer an inspector's
    questions or gather any information he requests.
  • Provide a clean, quiet area in which the
    inspector can work. Avoid using a heavily trafficked, noisy area
    (e.g., break room or kitchen). Bring all necessary documents to that
    room and have those ready for the inspector's review. Make yourself
    or other involved personnel available — take care not to “hover.”
  • Treat your inspector as if he were a guest in
    your home. Not only is this is a good time to dust the place but
    also to go through your lab inventory making sure that nothing is
    expired, including blood-collection tubes, which — yes — have
    expiration dates. Everything gets a good cleaning.
  • On the day the inspector arrives, greet him with
    a smile, and introduce the inspector to all the laboratory's
    inspection-engaged parties. This is a positive way to start the
    process. You might ask if the inspector would like to meet the lab
  • Bring the inspector to the nicely organized room
    you have prepared with all pertinent lab information. Offer him
    coffee or a cold beverage, and stay available to fulfill his
    refreshment needs, as well as to check in on his progress
  • For small to moderate size POLs, the inspection
    should take only half a day. Ask for a brief summary of the
    inspector's findings. A detailed evaluation should arrive within a
    few weeks, listing each deficiency and the required information
    needed to correct it.
  • After the inspector leaves, feel free to dance and cheer.

Tim “The Lab Guy” Dumas is a clinical laboratory scientist, manager, and consultant, and an accredited speaker through the National Speakers Association. He operates Tim Dumas Laboratory Consulting. Reach him through , or for information on his professional workshops, use .

When OSHA comes to call

From the Safety Lady,Terry Jo Gile, MT(ASCP), MA Ed

A typical day in the lab begins — you come to work and
settle into your desk chair — then there is a knock on the door. You
answer only to find a person in the doorway who says, “Hi, I am from
OSHA, and I am here to help you.” Before you panic or make a wrong move,
consider the following points:

  • Take the compliance officer directly to the CEO's
    office for verification of credentials and review the complaint. The
    name and title of the complainant will not be revealed in the
  • Gather managers and supervisors of the involved
    area(s) to attend the opening conference; take lots of notes.
  • Follow the compliance officer throughout the
    walk-through and record any deficiencies identified. Make sure the
    walk-through only covers area(s) cited in the complaint.
  • Provide personal protective equipment (lab coat,
    gloves, and more) before entering the testing area; failure to do so
    is an automatic violation with a potential fine up to $7,000.
  • Take photos of or videotape any photos or
    video(s) taken by the compliance officer, which will help when the
    time comes for abatement or fixing the citations.
  • If something cited can be fixed before the
    compliance officer departs, then fix it. This is called a “quick
    fix” and may still be cited — but no fine should be levied.
  • Do not volunteer any information — everything
    said and done during this visit is “on the record.”
  • Provide employees time to speak privately with
    the compliance officer who will give you a list of names or job
    titles to be interviewed — one of these will be the complainant.
    Most interviews will be 15 to 20 minutes for each of six to eight
    employees selected.
  • Attend the closing conference and, again, take
    lots of notes.
  • Ask questions about any citations.
  • Clarify the requirements for abatement of the
  • When the citations arrive, post copies at the
    site of the violation for three days or until these violations are
  • Prepare position on each citation and back-up
    documentation, as necessary.
  • Attorney involvement should occur before the
    paperwork is submitted to OSHA, and he should assist with
    negotiation of any fines.
  • Make sure all employees know the OSHA requirements and are able to
    recite them when asked. This includes policies and procedures on
    bloodborne pathogens, chemical hygiene, environmental monitoring (if
    applicable), and injury prevention.

Best-selling author, professional speaker, and safety consultant Terry Jo Gile has helped thousands of laboratorians create safety-savvy laboratories. Her book,
Complete Guide to Laboratory Safety – Second Edition, is considered the consummate safety reference tool specific to clinical labs. Her new computer-based safety-education games reinforce OSHA requirements for the clinical lab.

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