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Cytopathology in focus: How can a lab ensure individual competence?

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Onboarding in gyn and nongyn cytopathology

Barbara A. Crothers, DO
Janie Roberson, SCT(ASCP)CM
Kelly Goodrich, CT(ASCP)

January 2019—It is happening again: CAP members and cytotechnologists are asking about regulatory requirements for re-integrating into cytopathology after a period of practice latency.

That is good news because it indicates that they are interested in practicing at a time when the cytopathology community can use skilled professionals. The past decade has seen a shrinking volume of Pap tests and a concomitant decline in the number of practicing cytologists, which has created new job opportunities for those with cytopathology skills. Whether the practitioner is new to the field, new to an employer/laboratory, or back in the field from a period of latency, onboarding is a critical component of ensuring competency and good laboratory practice.

Let’s attack the regulatory issues first: specifically, how they apply to gynecologic cytopathology.

The Centers for Medicare and Medicaid Services CLIA ’88 regulations at section 493.855(a) say that a laboratory “must ensure that each individual engaged in the examination of gynecologic preparations is enrolled in a proficiency testing program approved by the Centers for Medicare and Medicaid Services.” As of 2018, there were only two approved Pap PT programs: the CAP and American Society for Clinical Pathology programs.

Who needs to take the Pap PT? Any individual who primarily examines and/or interprets (even one!) Pap test for clinical purposes during a calendar year.

Who is exempt from Pap PT? Researchers are exempt, as are the following:

  • Trainees (cytotechnologists, residents, and fellows)—exempt up to and including the calendar year of graduation.
  • Individuals who examine or interpret only nongynecologic specimens.
  • Individuals who are using previously reported Pap test slides for teaching.
  • Individuals who are reviewing Pap test slides solely for the purpose of presentation to tumor boards or planning conferences without an intended change in Pap test diagnosis.

The guiding principle is that if the individual is making an assessment of a Pap test for a diagnosis or for interpretation to provide information that can be used toward a diagnosis, he or she must participate in PT. For example, if a pathologist who does not interpret Pap tests reviews a Pap test slide for a tumor board and does not disagree with the diagnosis, she may present the findings at tumor board. However, if she disagrees with that interpretation and seeks changes in the diagnosis, then she is influencing patient care and should be proficiency tested. Similarly, any individual who is reviewing Pap tests and requests a revision of the primary cytologist’s interpretation of the Pap test should be proficiency tested, even if he or she does not primary screen or sign out cases.

Individuals who fail the initial Pap PT must retest with a two-hour, 10-slide test within 45 days of notification of that failure. There is no requirement that previously examined slides from that individual be rescreened.

Individuals who fail the second retest must obtain documented remedial training “in the area of test failure” and pass a four-hour, 20-slide PT. There is no time interval required to take the test other than that it must be in that calendar year. Remedial training can be in the laboratory and focus on cases that were misinterpreted. For example, if an individual calls a slide with HSIL as NILM, he or she can focus re-education on slides and courses on HSIL. In addition, all Pap tests screened/signed out by that individual prior to the test failure date must be re-examined. If an individual fails this third test, he or she must cease examining Pap tests from the date of failure notification and obtain 35 hours of documented, formal continuing education in diagnostic gynecologic cytology.

However, it’s not “three strikes and you’re out.” Those who fail the third test can complete as many cycles of testing (using the third test algorithm) as necessary to pass. Importantly, the individual must pass for that calendar year. If for some reason testing extends into the next calendar year and the individual passes, he or she must take a new initial 10-slide PT for the new calendar year. In addition, the individual must pass the calendar year PT in the program selected for that calendar year and cannot switch programs, hoping for an easier test, until he or she has passed the original PT program.

The regulations require that each individual pass an annual PT for the year(s) in which he or she practices. Individuals must complete initial testing by Dec. 31 of a given year, but the retesting can extend into the following year, to be completed no later than April 2 of that year.

Individuals need only take the test once a year, even if working for multiple different laboratories. If the laboratory does not provide Pap PT, the individual must obtain it independently. The CMS-approved PT programs can provide locum tenens Pap PT testing sites with proctors if a pathologist or cytotechnologist is unable to complete testing. This is often helpful for pathologists and cytotechnologists who do part-time or temporary work. Individuals must provide proof of their Pap PT completion to all laboratories with which they practice gynecologic cytopathology for each calendar year they practice. There is no federal mandate for nongynecologic cytology PT, but all individuals practicing cytology must be enrolled in an educational comparative program.

While successful PT is a requirement for practicing gynecologic cytology and is a definitive step in onboarding, perhaps a more pressing question for laboratories is: How do we ensure that an individual is prepared to practice cytopathology independently? The laboratory director is responsible for verifying an individual’s qualifications to practice. Apart from following CLIA regulations on personnel requirements for the practice of pathology and cytopathology, how can a laboratory attest to an individual’s competence, especially if she or he has not been practicing gynecologic cytopathology for several years?

Many laboratories use a pre-employment exam, structured similar to the PT slide set, as part of the interview process. While high performance on a one-time exam offers assurance, the real test of a competent cytotechnologist or cytopathologist is if they can identify and correctly interpret abnormal cells and if accuracy can be maintained over time and with significant volume. For this, particularly for cytotechnologists, slide sets of known abnormal Pap tests can be used in combination with a 100 percent prospective rescreen of the individual’s initial work, before final case reporting. With prospective screening, however, even at 100 percent, depending on the laboratory case mix, it can take time before the individual has the opportunity to “miss” a significant lesion. Study sets in combination with routine work can enrich and accelerate the onboarding process.

The 100 percent rescreen can be decreased gradually over time depending on screening performance. Intensive rescreening can be intimidating and place a person under great stress, but there are ways to create a positive environment for this review. Initial re-education with formal courses, review of existing study slide sets, and sitting in on sign-outs with competent pathologists and cytotechnologists can increase diagnostic confidence before independent reporting. Those who undergo onboarding should be encouraged to consult with colleagues for difficult cases. Prospective review of the individual’s cases should be viewed as an educational exercise to pinpoint areas of potential concern and supplement that individual’s experience with challenging cases or additional education.

The cytopathology director should establish a reasonable percent accuracy target based on prior episodes of 100 percent prospective review with others. It would be unfair to hold new personnel to standards that were not, or are not, applied to existing personnel. If a practice group has not been performing prospective review, then recruiting multiple cytologists of variable experience to serve as a reference pool and to be reviewed in conjunction with the onboarding individual would be a fair alternative to enable comparison. In cytopathology, supervisors commonly allow a one-step discrepancy as a partial agreement with an interpretation, recognizing that it can be impossible to obtain consensus, even among experts, for some interpretations such as atypical squamous cells-undetermined significance, atypical squamous cells-cannot exclude HSIL, and atypical glandular cells. In other words, a two-step discrepancy that might be considered an error would be an interpretation of negative for intraepithelial lesion or malignancy (NILM) on a slide containing cells meeting the criteria of low-grade squamous intraepithelial lesion (LSIL) (i.e. NILM→​ASC-US→​LSIL).

As laboratorians, we are drawn to tangibles; however, there are also relevant discussion points on intangibles that can put the onboarding practitioner and the employer at a greater comfort level. The iconic late Gary W. Gill, CT(ASCP), CFIAC, inventor of “Gill’s hematoxylin,” had proposed an alternative to rescreening the first 500 slides for newly onboarding cytotechnologists. Gill had extensive experience as a cytotechnology educator, scientist, and researcher. He pointed out that at the rate of SIL in the current population (median less than eight percent), rescreening 500 slides prospectively would be unlikely to capture significant screening and interpretive errors. He sought ways to remedy this problem and proposed systematic investigation of the person’s beliefs and education prior to rescreening cases, and to purposefully prepare practice sets for the individual to test and document performance. While not applicable or even attainable in all settings, these ideas warrant consideration for the onboarding process. Gill suggested (in his own words below, see bulleted lists) that supervisors inquire about the following:

Attitudes and beliefs

  • Do you modify your screening practices after you’ve been informed about a false-negative?
  • Do you think it’s possible to screen error-free (i.e. no false-negatives)?
  • Why do you think you miss abnormal cells?
  • How many slides an hour can be screened accurately?
  • How many abnormal cells must be present on a slide to be sure of finding at least one?
  • Do you think [liquid-based preparations] can be screened at the same rate as conventional Pap smears?

Training

  • How much were you taught to overlap?
  • How much do you overlap?
  • How do you know?
  • Do you overlap along each scan path, between each scan path, or both?
  • What were you taught about eyepiece magnification and field number as they relate to screening?

Experience

  • How many years have you screened? Where was this?
  • What was the total laboratory workload and the total number of cytotechnologists screening?
  • How many slides per day did you screen?
  • What was your error rate?
  • What were the screening expectations and quality assurance program at your previous employer?

Knowledge

  • What factors are at work in the process of finding abnormal cells?
  • What is the prerequisite for avoiding a false-negative Pap test?
  • Define vigilance in the context of screening.
  • Define an adequate smear, with particular emphasis on cellularity following the criteria outlined in The Bethesda System for Reporting Cervical Cytology.

Gill suggested the following practice sets and educational exercise to further assess an individual’s comfort with slide screening and interpretation:

Prepare a set of Pap smears, with faux requisitions, each of which exhibits some feature that can be used to test [an individual’s] response. Sit at a double-head microscope as they screen to observe their screening behaviors. Report your findings and recommendations.

  • Begin with unsatisfactory illumination. Can they fix it (i.e. Kohler illumination)?
  • Slide with few total cells. How do they find the cells and focal plane?
  • Slide with few endocervical cells. Did they find them? How did they look for them?
  • Bare nuclei only—how to report?
  • Few abnormal cells—how to find? Did they find them at all?
  • Screening coverage self-assessment—how much do they overlap in percent? Do they overlap along one dimension or two? How many total fields per slide do they examine on average?
  • Unsatisfactory preps—do they notice? How do they determine?
  • High-grade squamous intraepithelial lesion (HSIL) case or two.
  • Adenocarcinoma in situ (AIS) case.
  • ASC-US/atypical glandular cells (AGC) case.
  • Thick smear—does the individual slow down and examine selected fields or simply whiz past them?
Regardless of the onboarding process, the laboratory should develop a written policy outlining the steps and keep records documenting the process and outcome for each onboarded individual. While accurate screening and interpretation are essential requirements for a competent cytopathology practitioner, the laboratory must include documented review of appropriate SOPs and it should provide a clear definition of what it considers an error and communicate and document reasonable workload limits.

Throughout early employment and at scheduled intervals, feedback on one’s progress is essential, and there are metrics in addition to rescreening that, when compared to peers and lab overall, can offer insight into performance: cyto-histo correlation, HPV-positive ASC-US cases, estimated false-negative fraction, and diagnostic distribution. These numbers can help the individual more confidently align their interpretations with laboratory practice. This feedback is helpful for gynecologic and nongynecologic cytopathology. It is especially wise to compare the individual’s performance with that of the practice group as a whole. It is common for newly practicing, or re-entry cytologists, to resort to “atypical” interpretations initially, resulting in a high ASC:SIL (atypical squamous cells of undetermined significance to squamous intraepithelial lesion) ratio compared with the practice group. In nongynecologic cytology, the result may be too many “atypical” interpretations without a definitive diagnosis of tumor or cancer, a situation particularly aggravating to clinicians. These cases are rich sources for review, particularly when compared with subsequent biopsy or radiographic imaging results. Review can instill confidence and encourage an individual to downgrade Pap tests to reactive/negative, or upgrade them to LSIL or HSIL, where appropriate. Comparison with peers and discovering when others are definitive about a malignant diagnosis is also helpful. An experienced cytologist should review these cases with the individual to explain the features that may promote a more definitive interpretation.

As mandated by CLIA, the technical supervisor must review performance and set workload at least every six months based on that performance. This practice should ensure there is ongoing and active review and feedback about the cytotechnologist’s work. While this is required for primary screeners only, routine feedback is also good practice for cytopathologists. Good cytopathology laboratories know constant engagement with the practicing cytologists and sharing of difficult and classic cases is a key to quality practice. The skills of isolated practitioners may degrade over time; engagement by telecytology and web-based education is available for such practitioners. In the future, a reduction in the prevalence of squamous intraepithelial lesions owing to better penetration of the HPV vaccine will likely result in fewer SIL cases. The national rate of high-grade SIL is already very low (less than one percent) and may decrease further, requiring case review to ensure that cytologists are fine-tuned to the identification and diagnostic features of less prevalent lesions in gynecologic and nongynecologic cytology.
Successful onboarding serves the employee and employer in establishing expectations and verifying performance. This is one of the best practices a laboratory can establish in its aim to provide good patient care.

  1. 1. Centers for Medicare and Medicaid Services. Center for Medicaid and State Operations: Informational supplement (2006): Medicare, Medicaid and CLIA programs: statutory and regulatory requirements related to laboratory participation in proficiency testing and the availability of proficiency testing programs in cytology. www.cms.gov/regulations-and-guidance/legislation/clia/downloads/informational_supplement.pdf. Published Jan. 26, 2006.
  2. Tworek JA, Henry MR, Blond B, Jones BA. College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization. Arch Pathol Lab Med. 2013;137(2):158–163.

Dr. Crothers, former chair of the CAP Cytopathology Committee, is associate professor of pathology, Uniformed Services University of the Health Sciences, and senior consultant for gynecologic, breast, and cytopathology, Joint Pathology Center, Silver Spring, Md. Roberson, a member of the CAP committee, is manager, laboratory quality and anatomic pathology, University of Alabama-Birmingham. Goodrich is senior cytology technical specialist, College of American Pathologists, Northfield, Ill.

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