HPV Follow-Up [Cervical Cancer]
Case #155
A 32-year-old woman presented to her gynecologist for an annual exam in April 2016.
She underwent co-testing with Pap test and HPV testing.
Pap test was negative but her HPV test was positive.
She was advised to return in a year for repeat testing.
The relevant guidelines from the 2019 ASCCP Risk-Based Management Consensus Guidelines are shown below (red box added for emphasis).
If she had a positive HPV test in a year, her gynecologist planned to do a colposcopy.
Later that year, she became pregnant.
She switched her care to a different OB group.
She delivered a healthy baby boy in July 2017.
She had a repeat Pap and HPV testing in September 2017.
As before, Pap test was negative but her HPV test was positive for high risk HPV.
However, her new OBGYN did not realize she already had a positive HPV test a year earlier, and therefore did not proceed with colposcopy.
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In September 2018, she returned for another visit.
A Pap was completed (again negative).
Her cervix reportedly appeared normal.
HPV testing was ordered but apparently was never completed nor reported.
2 months later in November 2018, she developed vaginal bleeding.
Ultrasound revealed a cervical mass.
Pap test confirmed squamous cell carcinoma.
Her care was transferred to a gynecologic oncology specialist.
She underwent a radical hysterectomy and partial vaginectomy.
She also underwent chemo and radiation therapy.
Sadly, the patient died several years later at 35-years-old.
She left behind a 2-year-old boy.
A lawsuit was filed before she died.
She sued the OBGYN physician for not realizing that a previous HPV test was positive, for failing to repeat HPV testing (it was ordered but never done), and for failing to do a colposcopy.
An expert witness was hired and wrote the following opinion:
A confidential settlement was reached before trial.
MedMalReviewer Analysis:
Once again, communication issues played a key role in a malpractice case. The OBGYN did not realize that the patient already had a positive HPV test.
The appropriate HPV test was ordered but not actually done. Once we order a test, we often assume it’s being done unless informed that there was an issue. The dangers of that assumption are illustrated in this case.
This isn’t the first lawsuit I’ve covered related to HPV and squamous cell carcinoma. This previous case involved a 49-year-old man who developed a tonsillar mass that was positive for HPV, and died of carotid blowout syndrome. Fortunately, there’s an HPV vaccine that significantly reduces the odds of these cancers.
I’d love to get some comments from OBGYNs about 2 questions:
She had a (reportedly) normal cervix on physical exam in September 2018, and two months later had a 3.5cm x 4.4cm cervical mass. Does this seems like a relatively fast development of a mass this size?
Do you agree with the expert’s claims about the appropriate follow-up?
Prior OBGYN Cases:
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Oh now you got me started.
This case sounded so familiar I had to do a double take. It's not the same case but I knew of one VERY similar case.
"She had a (reportedly) normal cervix on physical exam in September 2018, and two months later had a 3.5cm x 4.4cm cervical mass. Does this seems like a relatively fast development of a mass this size?"
My answer is yes, but my understanding is that is the natural history of cervical cancer. It is VERY slow growing, but the mutations that allow CIN-3 (not necessarily visible but a true precancer) to break through the basement membrane are also the ones that allow for its rapid proliferation, direct and lymphatic spread and eventual metastasis. While progression from infection to carcinoma may take 7-14 years, the majority of that time is spent in INTRAepithelial dysplasia, growth may be rapid after extraepithelial neoplastic conversion. The reason HRHPV when genotyped to 16 or 18 is by itself an indication for colposcopy is that the "immediate risk of CIN 3+ is 5.3%" (ie at the time of pap) - see ASCCP smartphone app - (DeMarco, M, et al. A Study of partial human papilloma virus genotyping in support of the 2019 ASCCP risk-based management concensus guidelines. J Low Genit Tract Dis 2020) Though this article is newer than this case, this same logic applied at the time of this case in 2017.
"Do you agree with the expert’s claims about the appropriate follow-up?"
If by followup, you mean, "if retesting 12 in months still finds HPV then referral for colposcopy is indicated," then yes, I do agree about the appropriate followup. This is true if HPV genotyping is not performed. If HPV genotyping is performed and the type is 16 or 18, then colposcopy is recommended. Interestingly, in an UNTYPED cohort, the 5 year risk of CIN 3 is 4.8% (Egemen, D et al. Risk estimates supporting th e2019 ASCCP Risk based Manageement Concensus Guidelines. J Low Genit Tract Dis 2020)
If by followup you mean, "When a physician orders a test, the standard of care requires the physician to follow up on the results," I do NOT agree for missing results when an order is placed even though it is the standard we are held to. I feel very strongly that CO-TESTING must then CO-REPORT the results and that any deviation from that creates a high-risk environment for missed results. Even though administrators and programmers carved a gaping hole in the swiss cheese, the physician is held responsible for lab error. It is VERY difficult to see something that is NOT there.
Despite my exhortations to both my Arizona and now Pennsylvania employer, the results for cytology and co-testing are frequently reported SEPARATELY (and on *different days*) because of technologic vagaries such as, "lack of a field for string inputs" or "change in software vendor resulting in disruption of the backend reporting link." In my current employer, for example, the Pap result makes NO MENTION of HPV testing. The HPV testing result is located on an entirely different results screen and is not reported with pathology results but rather with virology results. Labs return results in different time frames and as a result, not only are physicians held responsible for the results they DO receive, they are held equally responsible should the lab forget or incorrectly report results. My current employer requires patients to present a requisition slip, but the lab will ONLY draw from the requisition provided. If the patients sees two doctors who each order labs, but the patient takes only one requisition slip, only those labs will be drawn even if the computer orders are readily available. My employer does not believe this is a problem.
HPV reporting is a giant malpractice trap and lawyers know it. Missing cervical cancer frequently results in windfall judgments. I lost a young work colleague to cervical cancer in a situation almost identical to this one. The multimillion dollar verdict is small consolation to her children. I wish I could say I won't make this error, but the truth is, I almost certainly will because missing a result is a matter of probability when an administrator doesn't care how hard it is to find a result. Just put yourself in the ob-gyn's shoes. She ordered a pap with HPV. The HPV result isn't present. She calls the lab. The lab says, oh, I see the order, it must still be in process, the result will come to you shortly. She closes the pap result because her employer harangues her if the box isn't emptied regularly. The HPV result then never comes. HOW IS THE OBGYN SUPPOSED TO KNOW? Missing result alerts? They were broken at my last employer because the NEVER got the backend link between the pap/HPV computer order and LabCorp system working. To send LabCorp paps (because of insurance requirements), we had to use paper requisitions. Those were initially not reported electronically. When labcorp begans sending electronic results, they were not attached to the computer based order. This resulted in a result but also a No-Result alarm. We spent INORDINATE amounts of time painstaking making sure we checked that all paps going out came back. We did Q6 month complete audits to double check our work. And we still found we missed about 2 a year.
I am an Operating Room Nurse and a Pathology Nurse and do Legal Nurse Consulting as well. As a Pathology Nurse I make sure that any test result that is considered abnormal is sent to the doctor directly. It is true that results are not reported together because specimen samples goes to different departments with different pathologists. A facility can be held liable for missed diagnoses as well, therefore they should have someone dedicated to reading and tracking results. My facility uses 8 different pathology companies with 8 different processes for receiving reports and we send out around 50 specimens for processing each week. I am constantly hunting down pathology reports that are missing and sending over results to avoid missed diagnoses. In this case, a pathology nurse would have intervened once that second test was never reported.