laboratories are highly regulated operations requiring strict
adherence to standards and regulations to be granted accreditation.
As part of the accreditation process, a laboratory must be inspected.
For laboratory staff, the regular inspection cycles produce some of
the most stressful experiences they will likely have while working in
a lab. Fortunately, whether it is an initial or biennial inspection,
there are some standard tasks and duties a laboratory can do to
prepare in advance to reduce stress, smooth out the inspection
process, and reduce the risk of getting a deficiency.
the United States, there are seven accrediting
approved by CLIA to accredit laboratories performing patient testing.
This series of articles will discuss preparing for an inspection
conducted by the College of American Pathologists (CAP).
1946, the CAP has grown from a small group of pathologists to a
world-renowned, international laboratory accrediting organization.
In 1949, the CAP conducted its first chemistry survey. Today the
organization operates one of the largest and most extensive
proficiency-testing programs in the world. Along with providing
proficiency testing surveys required by CLIA, the CAP also perform
onsite inspections of laboratories.
laboratory is required to have an onsite inspection every two years
to meet accreditation requirements. Depending on the laboratory's
size, the CAP inspection team may consist of 1-3 inspectors to teams
comprised of 40 or more inspectors. (The large teams are usually for
system inspections of laboratories with many specialties.)
on the size of the laboratory, inspectors may be onsite one day or an
entire week. Other than the initial inspection, all CAP biennial
inspections are unannounced. For an unannounced inspection, the
laboratory is given a 90-day window in which the team may arrive.
There are no further notifications given within the 90-day window
other than when the team arrives the morning of the inspection.
a CAP inspected laboratory may be subject to a CMS validation
inspection within 60 days after the CAP inspection.)
Laboratories should strive always to be inspection-ready. However, there are things even the most well-run laboratory needs to do in preparation for the inspection. Some of the smallest items can go a long way in reducing inspection-related stress. Here a few:
Call-tree: It is a great idea to have a call-tree ready. A call-tree is a list of people to be contacted when the inspection team arrives. Share the list with the hospital’s front desk (or front customer service area for an independent laboratory), as this is where the team will first present itself. Front desk personnel can be tasked to call the people on the list or directly contact the laboratory.
Conference room: Have a room reserved large enough for the inspectors to work. In our COVID-19 world, ensure there is enough room for social distancing and that there are a sufficient number of tables for the inspectors to review manuals and other documentation. (Note: The CAP has been working on some hybrid-model inspections consisting of video and onsite inspections. The laboratory should be prepared for either type of inspection model. Virtual Inspections are discussed in the next installment.)
Document management: If the laboratory has an electronic document control system, create a process for the inspectors to view documents online. Some laboratories set up dedicated personal computers or laptops with a sign-on specific for the inspectors. Other laboratories will assign personnel with computer access to each inspector. The latter method can be problematic if social-distancing is to be maintained. (If the laboratory uses a paper document control system, see the note in number 4.)
Cart availability: Have a cart ready. All proficiency surveys performed since the last inspection are required to be reviewed. Surveys are generally kept in CAP books. As a result, many books often need transportation to the room where the team is located. (Note: Paper procedure manuals, QC logs, and worksheets will also need reviewing, but if used in a testing area, they should not be in the inspection team’s clean location.)
Coats and gloves: Ensure enough lab coats and gloves are available for inspectors. Some laboratories use non-disposable lab coats and will need to make certain there are enough for all inspectors.
Obvious deficiency targets: Discard all low-hanging deficiency material. Inspectors consider expired items low-hanging deficiencies because they are so easy to find. Expired reagents, quality control material, and timers are some of the most frequently found items causing a deficiency. Laboratories should be proactive in checking refrigerator/freezer thermometers and timers to ensure calibrations have not expired.
Prior inspection review: Review deficiencies received in the last inspection and ensure all have been corrected. Inspectors are tasked to check if the previous inspection's deficiencies are fixed and the corrective actions are being maintained. (Note: there will be no deficiencies to review if this is an initial inspection.)
of the recommendations discussed so far may seem obvious or
straightforward. Still, you would be surprised at how often
inspectors arrive at a lab and are informed there isn’t a room
large enough to accommodate everyone. Inspectors’ perception of
the lab may be negatively impacted if the laboratory is not ready or
if they have to wait for responsible staff to arrive. (The inspection team may wonder if the lab is purposefully delaying the
concludes Part 1 of this two-part series. In the next
installment, staff preparation will be discussed, along with some
questions staff should be prepared to answer when an inspection team
walks through the door.
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