8 Comments
Apr 18, 2023Liked by Med Mal Reviewer

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.

Expand full comment
author

Wow! I can tell this case really touched a nerve. This is probably one of the most insightful comments I've ever gotten on a case. I've had a few other obgyns reach out too and say standard of care with high risk hpv would have been to go directly to colposcopy. hopefully your admins will come around with enough prompting,,, sounds like an overlooked pt safety issue!

Expand full comment
Aug 29, 2023Liked by Med Mal Reviewer

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.

Expand full comment
author

It gets pretty complicated using that many companies, glad there are pathology nurses to help keep everything organized!

Expand full comment

I am a Board Certified OBGYN and have acted as an Expert Witness for both sides in the past.

This case is not unusual in that the patient was seen by multiple providers and often times there is no good follow up of past results including Pap smear/HPV testing or Biopsy Results. This patient unfortunately had not follow up. Due to seeing this over a long period of time in OBGYN practice, ANY time a Pap smear, HPV test, or Biopsy is done I ALWAYS provide a COPY of the results to the patient so they can FOLLOW UP with a provider in the future. If this was done the patient would have been evaluated further with a colposcopy. Often times these fine details are overlooked by a busy OBGYN office. In addition, there was a discrepancy in the pelvic exam performed by the OBGYN and what was found by the Oncologist with the delayed diagnosis of Uterine Cancer. In my 25 years of experience as an OBGYN I have found the picking up cancer with a "cervical mass" is not usually done by the General OBGYN but rather a subspecialist such as a GYN Oncologist. Many factors affect this such as body habitus and ability to adequately feel the cervix, uterus, and adnexa. If the OBGYN provider cannot see a large cervical mass on speculum exam then the pelvic examination doesn't reveal anything additional unless there is pain or a large mass that can be felt. This is not unusual for many pelvic exams that are done. It is unfortunate in this case that an abnormal result on a Pap smear was never followed up and the patient died from a preventable cancer that can be cured if recognized and treated early.

Expand full comment

OB/GYN here. Routine screening with cytology alone every three years is an option within ACOG/USPSTF guidelines, however in this case there was a known normal cytology, HPV+ Pap one year prior. For such cases, the one year follow up has to test for both, as pretty much any abnormality would prompt colposcopy. Spontaneous SCC tends to develop quickly; assuming it was HPV mediated the lesion may have been within the endocervix. Colposcopy exists because you can't evaluate the entirety of the cervix or diagnose cancer/pre-cancer with Pap smears and the naked eye. Even knowing this reading the case was painful because obtaining clearly reported results can be such a struggle depending on the lab, adds one more thing for physicians to police while seeing pts, most EMRs are not designed to make pulling up historical results easy, etc.

Expand full comment

Unfortunate case and another shortcoming of the American healthcare system. Patients often assume we have everything “in their records” but it’s often very difficult to get prior results

Expand full comment

I’m an EM doc so I virtually never request outside records since by the time I got them my shift would be over and they don’t usually make a difference in immediate management anyway. The case seems to hinge on whether the second ob gyn was responsible for obtaining records from the first. This is often difficult to do - I guess since I’m not an OB GYN I don’t know how standard it really is or whether doing so is the standard of care

Expand full comment