Lydia Pleotis Howell, MD
Accreditation inspections are inevitably stressful events. Having a colleague you’ve never met walk through your lab with a checklist looking for how you’ve slipped up reminds me a bit of my mother’s first visit to my apartment when I was a newlywed. I had cleaned everything, including every nook and cranny that weren’t part of my usual routine. I even bought a new shower curtain to ensure no possible hint of mildew. I thought the place looked terrific and that my high level of preparation would surely be sufficient to meet my mom’s white glove standards. Little did I expect that she would peer down the shade of my living room lamp shortly after arriving and remark that I really should dust my light bulbs.
It is hard to ever be fully prepared for a June Cleaver mom or to read the mind of a CAP inspector. Fortunately, deficiencies in cytopathology are relatively infrequent and don’t involve eliminating dust on light bulbs. Nonetheless, being aware of the top three checklist items that are most often cited as phase one and two deficiencies can be helpful in your inspection preparation and will assist you in avoiding pitfalls.
According to the CAP’s data from inspections occurring between Nov. 1, 2011 and Nov. 1, 2012, the most common cytopathology checklist item for a phase one deficiency was CYP.07690, which requires that 90 percent of reports on routine nongynecologic cytology cases be completed within two working days of receipt by the laboratory performing the examination. Citations for this checklist item constitute four percent of all the phase one deficiencies. It is important to note the word “routine” in this requirement, and to be sure you are collecting statistics only on your routine cases. Cases that involve special processing or extra studies such as immunohistochemistry or molecular analysis are not considered routine, and longer turnaround times are acceptable. However, the lab must also provide a reasonable targeted reporting time for the non-routine cases. Documenting turnaround time may not always be as easy as you’d like it to be due to constraints in your laboratory information system, which may not be able to distinguish working from non-working days, or routine from non-routine cases. The CAP inspector will therefore not require continuous monitoring and will accept periodic auditing of reports as an acceptable alternative.
The second most common phase one deficiency in cytopathology (2.7 percent of all deficiencies) involves CYP.06450, which requires a policy regarding communication of significant and unexpected cytopathology findings and documentation that such communication is occurring. Laboratories can create their own list of significant and unexpected findings that fits their own practice environments, resources, and client needs. We all know how difficult it can be to contact busy clinicians to communicate unexpected findings. Fortunately, the CAP accreditation checklist recognizes this difficulty; this checklist item notes there must be “reasonable” efforts to ensure these diagnoses are received by a clinician and that a variety of means can be employed, such as phone calls, pager, or other notification. The need to document the date the notification occurred is another common pitfall in this requirement. Notification methods such as e-mail or messaging through the electronic health record can make it easier to meet all aspects of this checklist requirement since a dated and traceable message can be sent that is available at the clinician’s convenience.
Close behind at No. 3 among the phase one deficiencies (2.3 percent of all) is a fairly new checklist requirement that was added in July 2011, CYP.01650, which requires that laboratories have a policy listing specimens that an institution may choose to exclude from routine submission for cytologic examination. The laboratory must also provide documentation that this list of exclusions was made in collaboration with the institution’s medical staff to ensure that the needs of laboratory and clinician are considered. Since not all laboratories are part of a larger institution or health care organization, this checklist requirement does not apply universally to all laboratories. Additionally, this checklist item does not obligate laboratories to create a list of exclusions; laboratories are fully able to require cytologic evaluation on all specimens, if they so choose.
Phase two deficiencies aren’t any more common than phase one deficiencies, and none exceeds five percent. Workload requirements are among the most common inspection pitfalls since they account for two of the top three phase two deficiencies. CYP.08500 requires a documented workload policy for manual screening with evidence of data recording, but applies only to U.S. labs. Though CLIA regulations specify 100 slides per day as an individual screening maximum, some states may have more stringent requirements that must be included in the policy. Just as for all checklist requirements, the laboratory must provide documentation of compliance; thus, records of workload screening must be available for each person. These records must demonstrate that workload has been prorated for those who work fewer than eight hours in one day, and to accommodate time spent in duties other than screening. Cytotechnologists are responsible for maintaining their own workload records (CYP.08300) and, if an individual works in more than one laboratory, this must include documentation of workload from all places of employment.
CYP.08575 is the other common deficiency and requires that laboratories have a policy to establish individual maximum workload for the screening of cytology slides. This requirement recognizes that the slide limit defined by CLIA or state regulation is a maximum and that an individual may require a lower maximum to ensure safety and quality. The policy must include a reassessment of the workload limit at least every six months, and it must describe the criteria used to monitor and determine workload. It can include common quality indicators such as findings from 10 percent rescreens, comparison of cytotechnologist interpretation with final diagnoses, comparison of individual performance statistics with overall laboratory statistics, or other methods the laboratory deems appropriate.
Lastly, the most common phase two deficiency is about remembering to sign your policies and procedures—not a tough requirement but tough to remember. Recently the requirement changed from annual review and signature to every two years. Maybe this will be easier since plenty of labs forget to get that annual signature; on the other hand, the longer time interval may make it even easier to forget. Use your calendar, create a tickler file—you know what to do. And while you are at it—it might not hurt to dust your light bulbs, too.
Dr. Howell, a member of the CAP Cytopathology Committee, is professor and chair, Department of Pathology and Laboratory Medicine, University of California, Davis Health System, Sacramento.