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A 56-year-old woman’s annual mammogram showed a lesion in her right breast.  A needle core biopsy of the lesion was obtained on 4/28/2014.  A general pathologist reviewed the patient’s slides and diagnosed the patient with an invasive well-differentiated ductal carcinoma of the right breast.  Based on his diagnosis, the general pathologist ordered immunohistochemical stains for estrogen and progesterone receptors and other tests.  A surgical follow up was recommended.

The patient was referred to a surgeon who informed her she would undergo an immediate lumpectomy.  The patient sought further consultation from a general surgeon and plastic surgeon for evaluation and treatment of the cancer and reconstructive surgery.  The patient met with both on 5/6/2014, at which time she elected to proceed with a bilateral mastectomy, followed by breast reconstructive surgery. The general surgeon’s records show he ordered a consultation with the John Stoddard Cancer Tumor Board for another opinion. The general surgeon contacted the general pathologist and informed him of the findings.  On that same day, the general pathologist sent the slides to Mayo Clinic to be re-read.  The general pathologist also scheduled the case to be discussed at the Marshalltown Medical and Surgical Center’s Tumor Board on 5/19/2014.

The Mayo Clinic issued its report on 5/20/2014, diagnosing a complex sclerosing lesion with unusual ductal hyperplasia and microcalcifications.  On that same date, the general pathologist authored an addendum to his pathology report amending the diagnosis to conform with that of the Mayo Clinic and adding the following comment:

“The case is reviewed for tumor board.  After reviewing the case, the case was sent to Mayo Clinic for a second opinion and the [sic] diagnosis is changed from invasive ductal cell carcinoma to complex sclerosing lesion.  The changes in the diagnosis are communicated with the general surgeon.  Results of the correct report will be discussed with the patient by the general surgeon”.

The patient underwent a lumpectomy performed by the general surgeon on 5/22/2014.  Iowa Pathology Associates reviewed the slides from the lumpectomy and issued a histopathology report confirming the diagnosis of a complex sclerosing lesion.  The report stated, “there is no evidence of atypicality or malignancy.”

An audio recording made by the patient’s husband of a discussion he and the patient had with the general pathologist regarding the misdiagnosis was admitted into evidence.  In response to an inquiry regarding why the second opinion was not obtained prior to making an initial diagnosis, the general pathologist cited to the cost of a consultation.

A senior pathologist at the Iowa clinic reviewed the patient’s slides at the Board’s request and, in contrast to the general pathologist’s carcinoma diagnosis, arrived at a diagnosis of “radial scar” which term is often used interchangeably with “complex sclerosing lesion”.  The senior pathologist testified that she found the diagnosis to be an easy one and that an “average pathologist” would have been able to make it.  However, in her written report the senior pathologist relied on a textbook, which contained the following passage: “The importance of recognizing various patterns of adenosis and sclerosing lesions, and the reason why they are considered together in this chapter, is that they may be mistaken for invasive carcinoma…”  The senior pathologist noted that the condition she diagnosed is benign, although complete excision of the lesion is generally recommended if the diagnosis has been made on a needle biopsy because of the risk of associated malignancy which can be identified only after surgical excision.

The senior pathologist also questioned the general pathologist’s use of special stains in this case.  She explained that myoepithelial cells are not present in invasive cancers and, therefore, stains can be used to look for those cells.  If a stain is used and it shows that myoepithelial cells are present, the sample would not be consistent with invasive cancer.  The senior pathologist emphasized that had the general pathologist ordered the appropriate stains, such as P63, to confirm or rule out cancer in the patient’s case, he might not have misdiagnosed cancer.  On the other hand, the senior pathologist argued that the stains the general pathologist ordered were for breast cancer receptors (estrogen and progesterone) and for human epidermal growth factor receptor 2 (“HER2”) status and that the HER2 was sent for fluorescent in-situ hybridization (“FISH”) analysis, all of which were unnecessary because the patient did not have breast cancer.  The senior pathologist noted that these unnecessary steps added substantial costs to the patient’s care.

The senior pathologist emphasized that this patient might have undergone an unnecessary lumpectomy or mastectomy had her case not been reviewed further.  The senior pathologist found that the general pathologist failed to meet the standard of care when he misdiagnosed the patient because of a substantial lack of knowledge or ability to discharge the professional obligations within the scope of pathology practice.  She also determined that the general pathologist’s actions, in this case, showed a failure to possess and exercise the degree of skill, learning, and care expected of a reasonable, prudent physician acting in the same or similar circumstances.

In response to the Board’s inquiry regarding this patient, the general pathologist admitted his initial diagnosis was incorrect.  He stated, however, that he read the patient’s slides a few days later while preparing to present the case at a Tumor Board and began to have second thoughts about the diagnosis.  According to the general pathologist, he “mentally” amended the diagnosis at that time to being “suspicious of cancer”.  The general pathologist stressed that he discussed the case with the patient’s clinician and also sent it to the Mayo Clinic for a second opinion.  He explained that complex sclerosing lesions are very difficult to evaluate and are subject to misdiagnosis.  The general pathologist testified that when he received the pathology report from the Mayo Clinic on 5/20/2014, he authored a correction to his original report, amending the diagnosis to complex sclerosing lesion with unusual ductal hyperplasia and microcalcifications.

The general pathologist further testified at a hearing that the HER2 test and FISH analysis were requested by the patient’s clinician and were obtained due to that request.

The general pathologist emphasized that he learned from his error in this case and now requests additional immunostains and/or second opinions in these types of cases.

Another pathologist reviewed the case and while agreeing that the general pathologist reached an incorrect diagnosis at the outset, disagreed with the senior pathologist’s determinations that the misdiagnosis and use of stains demonstrated any lack of professional knowledge or a deviation from the standard of care from the general pathologist’s part.  He opined that this type of lesion can be difficult to evaluate, especially when the general pathologist has only a small amount of tissue provided by a needle core biopsy as opposed to a completely excised lesion.  The reviewing pathologist also emphasized that, while the senior pathologist opined the general pathologist ordered unnecessary stains, the pathologists at Mayo Clinic ordered additional stains when they re-read the slides involved.

The other reviewing pathologist offered his opinion that the general pathologist did not display professional incompetence or any behavior harmful or detrimental to the public in his review of the patient’s case.

For this allegation and others, the Board judged the general pathologist’s conduct to be below the minimum standard of competence given (his/her) lack of professional competency and practice that was harmful or detrimental to the public.  The general pathologist was warned that such practice in the future may result in further disciplinary action against his medical license.

For this allegation and others, the Board ordered the general pathologist to arrange in the auditing of 5% of his cases by outside pathology laboratory approved by the Board and ensure that the auditing entity submits a report to the Board on a quarterly basis.  He was also ordered to obtain consultation with a board-certified dermatopathologist in all suspected melanoma cases and author a paper discussing the diagnostic criteria for well-differentiated squamous cell carcinoma and keratoacanthoma in vulvar tissue.

State: Iowa

Date: June 2017

Specialty: Pathology

Symptom: N/A

Diagnosis: Dermatological Issues

Medical Error: Diagnostic error, Unnecessary or excessive treatment or surgery

Significant Outcome: N/A

Case Rating: 4

Link to Original Case File: Download PDF

In April 2013, a nurse practitioner collected a skin biopsy from a 20-year-old patient’s back.  That biopsy was reviewed by a general pathologist, who diagnosed superficial spreading of malignant melanoma (“SSMM”).  He did not consult with any other pathologist or dermatopathologist prior to providing the nurse practitioner with the SSMM diagnosis.

The patient was referred for treatment and a surgical consult was requested by her treating physician.  The same biopsy material reviewed by the general pathologist was also read by two pathologists, at the surgeon’s request.  Those pathologists agreed with the general pathologist’s diagnosis of SSMM.

After the patient underwent an excision, she was referred to a dermatologic surgeon, for annual skin examinations. The dermatologic surgeon noted the patient’s surgical scar and a few irregular moles during his 2013 exam.  During the 2014 examination, the dermatologic surgeon noted one irritated nevus, which was removed but saw nothing atypical.

Subsequently, in July 2014, the nurse practitioner collected a new shave biopsy from the patient’s back, near the site of the former biopsy.  The general pathologist discussed the proximity of the lesions with the nurse practitioner and the two agreed that, upon gross examination, the present biopsy material was similar in appearance to the first.  Upon microscopic examination, the general pathologist again arrived at a diagnosis of SSMM.  Once again he did not consult any other pathologist or dermatopathologist prior to providing the diagnosis to the nurse practitioner.

The nurse practitioner contacted the dermatologic surgeon with the patient’s diagnosis.  The dermatologic surgeon questioned the diagnosis because he examined the patient only two months earlier.  The dermatologic surgeon requested and received the slide on which the general pathologist based his SSMM diagnosis.  When he reviewed the slide, the dermatologic surgeon believed it showed an irritated nevus and not SSMM.

The dermatologic surgeon sent the slide from the patient’s latest biopsy to Iowa Pathology Associates, to be re-read.  A dermatopathologist reviewed the patient’s slide.  He found nothing in the sample which would point to melanoma.  He determined the slide showed an inflamed compound nevus.  Because his diagnosis conflicted with the general pathologist’s diagnosis, the dermatopathologist consulted with four of his colleagues, each of whom agreed the slide was not SSMM but an inflamed nevus.

The dermatopathologist then reported his findings to the dermatologic surgeon, who then began to question the patient’s SSMM diagnosis in 2013 SSMM.  The dermatologic surgeon obtained slides from the 2013 biopsy which looked to him to be identical to the slide from the 2014 biopsy.  The dermatologic surgeon then sent these slides to the dermatopathologist for review as well.

The dermatopathologist reviewed the slides from the 2013 biopsy and, once again, arrived at a diagnosis of inflamed compound nevus.  He shared these slides with the same four colleagues previously consulted, and once again, each concluded that the SSMM diagnosis was incorrect and that the slides showed an inflamed compound nevus.

Based on the dermatopathologist’s  diagnosis, the dermatologic surgeon alerted the patient’s mother that the patient did not have melanoma and the patient avoided a second surgery.

At the hearing, the dermatopathologist expressed his concerns with the general pathologist’s misdiagnosis in the patient’s case.  The dermatopathologist explained that a diagnosis of melanoma often makes it difficult for the patient to obtain health insurance and often he or she cannot obtain life insurance.  The dermatopathologist also explained that people diagnosed with melanoma are prohibited from donating tissue or blood.  Finally, the dermatopathologist testified to his fear that if the general pathologist misdiagnosed an inflamed compound nevus as malignant melanoma, that he might also be misdiagnosing malignant melanomas as inflamed compound nevi, thereby potentially exposing patients to the risk of developing metastatic melanoma.

A senior pathologist testified that neither of the biopsy specimens collected from the patient showed features of malignant melanoma.  She noted that there was no upward migration of atypical melanocytes or Pagetoid spread of atypical melanocytes. The senior pathologist explained the melanocytes in the patient’s biopsies showed no evidence of cytological atypia.  The senior pathologist also took issue with the fact that the general pathologist ordered a Melan-A stain, which, while it might have been appropriate had the biopsies shown malignant melanoma, was unnecessary since the correct diagnosis was inflamed compound nevus.

The senior pathologist emphasized the emotional strain placed on a patient once given a diagnosis of malignant melanoma.  She also noted that such a diagnosis might well result in a wider excision of the biopsy site, a regional lymph node excision, and chemotherapy; all unnecessary for an inflamed compound nevus.

The senior pathologist, dermatopathologist, and dermatologic surgeon all testified to the difficulty of making a diagnosis of malignant myeloma.  The senior pathologist wrote in her peer review to the Board:

“In my practice, EVERY case I think is malignant melanoma goes out for second (and sometimes third) opinion; regardless of how certain I am that the lesion is indeed a malignant melanoma. I feel that the practice of skin pathology (dermatopathology) is very difficult when it comes to accurately classifying atypical melanocytic proliferations, such as malignant melanoma and dysplastic nevi. Without special training, I believe it’s best to get second opinions on these cases; however that is my opinion and may not be shared by all pathologists”.

Likewise, while the dermatologic surgeon testified he was not an expert in pathology, he asserted that the diagnosis of an inflamed nevus is not a difficult one to make. He did admit, however, that the subspecialty of dermatopathology was developed specifically because of the difficulty in diagnosing melanomas.  He noted that, in his practice, he sees “problem after problem” with the diagnoses provided by general pathologists and that, as a result, he will not accept a diagnosis from a general pathologist without confirmation by a specialist.

The dermatopathologist noted that the practice of pathology involves, at best, the subjective interpretation of objective data and, at times, less than objective data. He stated that malignant melanoma is a particularly difficult diagnosis and urged that confirmation of that diagnosis could and should be had through consultation with a pathology group with subspecialty expertise such as the pathology group at Mayo Clinic.

In response to the complaint regarding this patient, the general pathologist noted that his 2013 diagnosis of SSMM was confirmed by the Ames Pathology Group who reviewed the biopsy at that time at the request of the patient’s surgeon. He stressed that he read the 2014 biopsy with the knowledge that this patient had been diagnosed with SSMM and that the diagnosis had been confirmed the previous year. He also noted that the 2014 biopsy was taken very close to the site of the 2013 biopsy.  The general pathologist noted that this information caused him to lean towards an SSMM diagnosis.  He also explained that, since the biopsy was from the patient’s back, an excision with a wider margin would not lead to any cosmetic defects.  He noted he was aggressive in this case because he did not want the patient to come back with metastatic melanoma.  He stressed the difficulty of diagnosing pigmented skin lesions.

At the hearing, the general pathologist testified that he remained convinced the patient’s 2014 biopsy showed SSMM.

Another reviewing pathologist expressed a different opinion in the patient’s case.  He stressed that the 2013 SSMM diagnosis had been confirmed after the slides were reread by the Ames Pathology Group and that fact, along with histology of the 2014 biopsy, would have led him to classify the latter specimen as, at the very least, an atypical compound melanocytic proliferation which would not rule out melanoma. The other reviewing pathologist stated that his review of the specimen revealed extensive lymphocytic reaction in the dermis which, in some cases, can mask an infiltrating tumor, He noted that in his practice, this sample would have been sent out for a consultation with a dermatopathologist.  However, once again the reviewing pathologist found no professional incompetency or harm to the public in the general pathologist’s action with regard to this case

For this allegation and others, the Board judged the general pathologist’s conduct to be below the minimum standard of competence given his lack of professional competency and practice that was harmful or detrimental to the public.  The general pathologist was warned that such practice in the future may result in further disciplinary action against his medical license.

For this allegation and others, the Board ordered the general pathologist to arrange in the auditing of 5% of his cases by outside pathology laboratory approved by the Board and ensure that the auditing entity submits a report to the Board on a quarterly basis.  He was also ordered to obtain consultation with a board-certified dermatopathologist in all suspected melanoma cases and author a paper discussing the diagnostic criteria for well-differentiated squamous cell carcinoma and keratoacanthoma in vulvar tissue.

State: Iowa

Date: June 2017

Specialty: Pathology

Symptom: N/A

Diagnosis: Dermatological Issues

Medical Error: Diagnostic error

Significant Outcome: N/A

Case Rating: 4

Link to Original Case File: Download PDF

An 82-year-old female presented with swollen lymph nodes under her right arm. She underwent a core needle biopsy on 8/11/2014.  That biopsy failed to provide a sufficient amount of viable tissue from which to arrive at a definitive diagnosis, but the general pathologist was of the opinion that the sample was “suggestive not diagnostic of metastatic melanoma.”

On 8/26/2014, a right axillary lymph node excisional biopsy was performed on the patient and the sample was sent to the general pathologist. Because of the small amount of viable tissue, the general pathologist prepared a portion of the material for flow cytometry and the remainder in touch preparations, a method by which a thin layer of cells is distributed on a slide for examination.  There was insufficient tissue for a frozen section, which consists of a thin slice of tissue cut from a frozen specimen.  The general pathologist ordered eleven special stains and arrived at a diagnosis of malignant melanoma.

A senior pathologist reviewed this file and expressed no concerns about the general pathologist’s final diagnosis; however, she opined that his use of eleven special stains to rule out other forms of cancer was unnecessary.  The senior pathologist testified that the majority of pathologists are able to diagnose melanoma through touch preparations, although many would prefer a frozen section to rely on.  She opined that the tough preparations, in this case, showed such obvious signs of malignant melanoma that no stains were necessary unless the patient had a history of other cancer.  The senior pathologist testified, if that were the case, a single, inexpensive stain to confirm the diagnosis would have been appropriate.  She stated that the general pathologist’s use of eleven stains suggested a lack of knowledge both as to the appearance of malignant melanoma and as to the appropriate use of special stains.  She emphasized the unnecessary expense added to the patient’s treatment because of the use of these stains.

The general pathologist defended his use of stains in this case.  He stressed that this patient had no clinical history of cancers.  He further noted that he does not have the ability to do stains in his own lab and that specimens must be sent out for staining.  The general pathologist explained that the process involves several days and patients are often anxious to receive a diagnosis.  He noted that he orders all stains he might need when he sends slides out so as to avoid having to send them out a second or third time.  The general pathologist reported he has never had an insurer question his use of stains and that he is of the opinion that the number and type of stains to be used are at the discretion of the physician.  He stressed that his diagnosis of malignant melanoma was correct in this case and that a previous punch biopsy performed by an outside facility on a skin lesion on the patient’s right arm had been misdiagnosed as benign.  After the general pathologist’s diagnosis, the facility that reviewed the specimen from the punch biopsy amended its diagnosis accordingly.

Another pathologist agreed with the general pathologist’s diagnosis.  The other pathologist stressed that it is in the pathologist’s prerogative as to how many stains to order.  He noted that the general pathologist received the patient’s slides without a medical history.  The other pathologists admitted that he might have begun with fewer stains, but he appreciated that the general pathologist might have felt the need to order additional stains in order to rule out other types of malignancies.  The other pathologist was unwilling to deem the order of multiple stains a deviation from the stand of care.

The other pathologist further agreed with the general pathologist that misreading the patient’s previous punch biopsy by an outside facility demonstrates the difficulty of diagnosing melanocytic lesions.

The Board was unconvinced that the evidence presented regarding the general pathologist’s use of special stains met the definitions of either professional incompetence or practice harmful or detrimental to the public.  The state argued that the evidence showed a lack of appropriate knowledge as to when and which special stains to use.

For other various allegations, the Board judged the general pathologist’s conduct to be below the minimum standard of competence given (his/her) lack of professional competency and practice that was harmful or detrimental to the public.  The general pathologist was warned that such practice in the future may result in further disciplinary action against his medical license.

For other various allegations, the Board ordered the general pathologist to arrange in the auditing of 5% of his cases by outside pathology laboratory approved by the Board and ensure that the auditing entity submits a report to the Board on a quarterly basis.  He was also ordered to obtain consultation with a board-certified dermatopathologist in all suspected melanoma cases and author a paper discussing the diagnostic criteria for well-differentiated squamous cell carcinoma and keratoacanthoma in vulvar tissue.

State: Iowa

Date: June 2017

Specialty: Pathology

Symptom: N/A

Diagnosis: Cancer

Medical Error: No error found

Significant Outcome: N/A

Case Rating: 2

Link to Original Case File: Download PDF

A 72-year-old male was diagnosed with a malignant melanoma. On 9/24/2014, he underwent an excision of the left forearm skin and removal of the left sentinel lymph nodes.  Intraoperative frozen sections were prepared from the lymph node material and the general pathologist ordered two special stains, Melan A and HMB 45.  The general pathologist issued a report finding the lymph node material negative for metastatic melanoma.

A senior pathologist did not take issue with the diagnosis in this case.  Instead, she expressed her opinion that the general pathologist ordered inappropriate immunohistochemical stains on the lymph node samples.  In her peer review, the senior pathologist wrote: “There is no agreed upon protocol to do HMB-45 and/or Melan-A on sentinel lymph nodes to look for metastatic melanoma cells.”  She called the use of the stains unnecessary and stated: “This just adds cost to the patient.  Melanoma cells are very large and easy to see, therefore making these stains unnecessary.”

At a hearing, the general pathologist again argued that the use of stains is the prerogative of the doctor and that the stains he used were appropriate.  The general pathologist stressed that his diagnosis was not questioned by the senior pathologist.

Another reviewing pathologist supported the general pathologist’s use of stains in the patient’s case.  He noted that, in his own practice, he uses the same strategy employed by the general pathologist to evaluate the presence of microscopic metastases in lymph nodes.  The reviewing pathologist explained that the American Joint Committee on Cancer (AJCC) Staging Handbook recommends the use of stains for the detection of micrometastases and considers it acceptable to classify lymph node positive metastases based solely on staining of melanoma-associated markers.

The senior pathologist countered that both of the special stains ordered by the general pathologist are specific for melanoma.  She noted that the AJCC Melanoma Taskforce has recommended using one specific stain and one sensitive stain.  Stains which are specific for melanoma are useful to avoid false positives, while stains which are sensitive for melanoma are useful to avoid false negatives.  According to the AJCC using only specific markers can lead to missing up to 15% of malignant melanomas.  The senior pathologist remained convinced the general pathologist’s actions in ordering the stains he used violated the standard of care.

The Board was unconvinced that the evidence presented regarding the general pathologist’s use of special stains met the definitions of either professional incompetence or practice harmful or detrimental to the public.  The state argued that the evidence showed a lack of appropriate knowledge as to when and which special stains to use.

For other various allegations, the Board judged the general pathologist’s conduct to be below the minimum standard of competence given (his/her) lack of professional competency and practice that was harmful or detrimental to the public.  The general pathologist was warned that such practice in the future may result in further disciplinary action against his medical license.

For other various allegations, the Board ordered the general pathologist to arrange in the auditing of 5% of his cases by outside pathology laboratory approved by the Board and ensure that the auditing entity submits a report to the Board on a quarterly basis.  He was also ordered to obtain consultation with a board-certified dermatopathologist in all suspected melanoma cases and author a paper discussing the diagnostic criteria for well-differentiated squamous cell carcinoma and keratoacanthoma in vulvar tissue.

State: Iowa

Date: June 2017

Specialty: Pathology

Symptom: N/A

Diagnosis: Cancer

Medical Error: No error found

Significant Outcome: N/A

Case Rating: 2

Link to Original Case File: Download PDF

A 49-year-old female underwent a punch biopsy of the left labia on 7/15/2014.  The specimen was delivered to a general pathologist who issued a pathology report diagnosing keratoacanthoma (“KA”).  Under the “COMMENT” portion of the report, the general pathologist noted, “The specimen shows changes of a well-differentiated squamous cell carcinoma.”

The slides examined by the general pathologist were subsequently reread by another pathologist of Iowa Pathology Associates, who confirmed his diagnosis with a dermatopathologist and another pathologist.  The dermatopathologist arrived at a diagnosis of a well-differentiated squamous cell carcinoma with a 0.85 cm depth of invasion.

A senior pathologist reviewed this file and arrived at the opinion that the general pathologist diagnosis of KA, in this case, demonstrated a lack of professional competency and knowledge.  The senior pathologist emphasized the correct diagnosis here was well-differentiated squamous cell carcinoma.  She explained that a KA, as diagnosed by the general pathologist, is a lesion of sun-exposed skin, generally found in the elderly.  It is shaped like a wart and protrudes up from the skin surface, whereas this lesion was not protruding and was located on the vulva.  The senior pathologist acknowledged that some authorities believe a KA is a form of well-differentiated squamous cell carcinoma, but she opined the term should never be used to describe the type of lesion involved in this case.

At the hearing, the senior pathologist further explained that a KA is marked by a dome shape and a keratin core.  The sample in this case did not show those characteristics.  The senior pathologist stated that even more telling was the location of the tumor: KAs are found on skin that is exposed to the sun and the fact that this sample was of vulvar tissue should have led the general pathologist to the conclusion that it was not a KA.  The senior pathologist noted that while vulvar KAs have been reported in the literature, they are extremely rare.

The senior pathologist testified that the misdiagnosis in this case could have resulted in the patient receiving inappropriate treatment.  She explained that KAs do not usually metastasize and excision of the lesion with an adequate margin is the accepted treatment for such a tumor.  Squamous cell carcinoma, on the other hand, may develop lymph node metastasis and the accepted treatment is therefore much more aggressive, and may involve removal of lymph nodes and chemotherapy.  The senior pathologist offered her opinion that the general pathologist’s misuse of terminology demonstrated a lack of substantial knowledge or ability.

A surgical pathologist with Iowa Pathology Associates testified at the hearing.  He was asked to review the patient’s biopsy because of a concern the KA diagnosis provided by the general pathologist was incorrect.  The surgical pathologist noted that while a KA can look quite similar to squamous cell carcinoma, KAs are not found on the vulva.  He testified that he shared this biopsy with colleagues who had 250 years of combined experience and not one of them had ever seen a KA on vulvar tissue.  The surgical pathologist disagreed with the suggestion that this was simply a matter of semantics.  He stated that, while one might use the the terms KA and squamous cell carcinoma interchangeably if one is speaking of skin on the arm or another sun-exposed area, that is simply not the case with vulvar tissue.  The surgical pathologist also emphasized that this was a deeply invasive tumor, 0.85cm, requiring much more aggressive action than would be required for a KA.

A dermatopathologist also testified at the hearing that he reviewed the slides from the patient’s biopsy at the surgical pathologist’s request.  He agreed with the surgical pathologist and the senior pathologist that KAs are not found in vulvar tissue and are restricted to sun-exposed skin.  The dermatopathologist expressed his opinion that this was not a difficult diagnosis to make.

The general pathologist argued that the difference between his diagnosis and that of the Iowa Pathology Associates was only a matter of semantics.  He testified that some authorities use the terms KA and squamous cell carcinoma interchangeably.  He stressed that he used the term “well-differentiated squamous cell carcinoma” in the comment section of his report.  The general pathologist testified that, while KAs are generally found on sun-exposed skin, there have been reports in the literature of vulvar KAs.

In response to questions as to why he did not report the depth of the lesion, the general pathologist explained that he did not do so because the sample was from a punch biopsy.  He noted that he recommended the entire lesion be excised, which would have allowed him to make a concrete diagnosis of the sample and the depth of the tumor.

Another reviewing pathologist agreed with the general pathologist and refused to characterize the general pathologist’s conclusions as a misdiagnosis.  He testified the dispute in this case was involving terminology only and did not rise to a breach of the standard of care. He noted that, in addition to providing the diagnosis of KA, the general pathologist authored a comment in his report stating that the biopsy showed a well-differentiated squamous cell carcinoma.  The reviewing pathologist testified that many authorities consider a KA to be a low grade invasive, well-differentiated squamous cell carcinoma, while others regard it as a unique lesion.  The reviewing pathologist emphasized that even though the general pathologist did not refer to the depth of the lesion, he recommended complete excision.  The reviewing pathologist opined that the general pathologist met the standard of care in this case.

The Board did not accept the general pathologist’s and the reviewing pathologist’s portrayals of the dispute surrounding the patient’s diagnosis as one of semantics only.  The evidence is clear that the lesion in this case was not a KA, which is nearly always found on sun-exposed skin.  The evidence is also clear that, while some authorities believe a KA is a form of well-differentiated squamous cell carcinoma and use of the terms interchangeably when referring to a lesion on sun-exposed skin, the term “KA” is not used to refer to such a lesion in vulvar tissue.  Further, while the literature does contain a few instances of KAs on the vulva, those occurrences are exceedingly rare and happening upon such a case would be remarkable.  The general pathologist’s diagnosis in this case demonstrated an obvious lack of knowledge and departure from the standard of care applicable to the general pathologist.  The Board found that the general pathologist’s actions in this case amounted to professional incompetence and practice harmful and detrimental to the public.

For this allegation and others, the Board judged the general pathologist’s conduct to be below the minimum standard of competence given (his/her) lack of professional competency and practice that was harmful or detrimental to the public.  The pathologist was warned that such practice in the future may result in further disciplinary action against his medical license.

For this allegation and others, the Board ordered the general pathologist to arrange in the auditing of 5% of his cases by outside pathology laboratory approved by the Board and ensure that the auditing entity submits a report to the Board on a quarterly basis.  He was also ordered to obtain consultation with a board-certified dermatopathologist in all suspected melanoma cases and author a paper discussing the diagnostic criteria for well-differentiated squamous cell carcinoma and keratoacanthoma in vulvar tissue.

State: Iowa

Date: June 2017

Specialty: Pathology

Symptom: N/A

Diagnosis: Cancer

Medical Error: Diagnostic error

Significant Outcome: N/A

Case Rating: 4

Link to Original Case File: Download PDF

A 70-year-old female underwent a right vulva punch biopsy on 7/1/2014.  The sample was delivered to a general pathologist who noted pigmented cells within the epidermis.  The general pathologist ordered five stains to confirm the diagnosis and rule out Paget’s disease.  All stains were negative and the general pathologist arrived at a diagnosis of condyloma acuminatum with low grade vulvar dysplasia.

A senior pathologist disagreed with the general pathologist’s diagnosis in this case.  She described her findings as “[h]igh grade squamous intraepithelial lesion characterized by severe squamous dysplasia” and noted “[t]his lesion requires complete excision to rule out invasive squamous cell carcinoma.  A wider excision to include negative margins should have been performed.”

The senior pathologist offered her opinion that the general pathologist became sidetracked when he saw pigmented cells in the dermis and dying squamous cells in the epidermis.  The senior pathologist testified she thought those findings led the general pathologist to believe he needed to rule out Paget’s disease and malignant melanoma, which led to the ordering of the five special stains.  She explained that, in her opinion, the dying squamous cells looked nothing like Paget’s cells and the pigmented cells in the epidermis did not appear at all atypical as they would in a malignant melanoma.  The senior pathologist stated both the ordering of the stains and the misdiagnosis showed a deviation from the standard of care on the general pathologist’s part.  She emphasized this was not a benign lesion and the proper diagnosis, high grade squamous dysplasia, requires the excision of additional tissue to rule out invasive squamous cell carcinoma.

In response to questions about his diagnosis and the use of stains, in this case, the general pathologist noted that he saw large epithelial cells with prominent nuclei in the specimen which may be seen in Paget’s disease as well as other diseases.  The general pathologist explained he ordered stains to rule out Paget’s disease and melanoma in-situ.

A reviewing pathologist agreed with the senior pathologist that the general pathologist arrived at a misdiagnosis in this case; however, he did not agree that the misdiagnosis or the use of stains constituted a violation of the standard of care.  The reviewing pathologist opined that the histology warranted the use of stains to rule out Paget’s disease and melanoma and he did not believe the failure to report moderate to severe dysplasia would have resulted in improper management of the patient’s care.

For this allegation and others, the Board judged the general pathologist’s conduct to be below the minimum standard of competence given (his/her) lack of professional competency and practice that was harmful or detrimental to the public.  The general pathologist was warned that such practice in the future may result in further disciplinary action against his medical license.

For this allegation and others, the Board ordered the general pathologist to arrange in the auditing of 5% of his cases by outside pathology laboratory approved by the Board and ensure that the auditing entity submits a report to the Board on a quarterly basis.  He was also ordered to obtain a consultation with a board-certified dermatopathologist in all suspected melanoma cases and author a paper discussing the diagnostic criteria for well-differentiated squamous cell carcinoma and keratoacanthoma in vulvar tissue.

State: Iowa

Date: June 2017

Specialty: Pathology

Symptom: N/A

Diagnosis: Dermatological Issues

Medical Error: Diagnostic error

Significant Outcome: N/A

Case Rating: 2

Link to Original Case File: Download PDF

A 74-year-old female underwent a vulvar punch biopsy on 7/11/2014.  A general pathologist reviewed the specimen and arrived at a diagnosis of lichen sclerosus, a nonmalignant condition.

A senior pathologist arrived at a diagnosis different from that of the general pathologist’s lichen sclerosis diagnosis. She found “[s]kin showing foamy histiocytes, chronic dermal inflammation, and hemosiderin deposition, with a subepidermal vesicle.”  She believed the changes represented a reaction to an injury which could be from a ruptured cyst or gland.  This is also a nonmalignant condition; however, the patient would be managed differently than would a patient with lichen sclerosus.

At the hearing, the senior pathologist emphasized that she saw no features of lichen sclerosus in her review of the slides.  She explained that lichen sclerosus features inflammation running parallel to the epidermis and that was not the case in the patient’s specimen.  She also testified that the pathology report issued by the general pathologist did not contain his microscopic findings so she was unable to determine exactly what features he saw that led him to his diagnosis.  The senior pathologist found the general pathologist did not meet the standard of care in this case.

The general pathologist noted that he found this to be a “rather straight forward case”.  He stated that his diagnosis fits the patient’s age, the clinical information supplied, and the histomorphology.  At the hearing, he pointed out that, even though the senior pathologist criticized his diagnosis, she did not provide a definitive diagnosis herself but only a descriptive diagnosis.  The general pathologist explained that he looks at possible cancer cases, such as this, first thing in the morning when his mind is fresh.  After he is able to rule out malignancy, as in the patient’s case, he waits for the surgical biopsy to correlate his initial diagnosis.  Once again, the general pathologist stressed that the patient did not have a malignant lesion.

Another reviewing pathologist disagreed with the senior pathologist’s diagnosis.  He found the general pathologist’s diagnosis to be more appropriate.  The reviewing pathologist opined that the biopsy “most likely represents a hypertrophic variant of lichen sclerosus et atrophicus, which has some evidence of trauma or irritation in the recent past.”  He stressed that he did not believe the general pathologist arrived at a misdiagnosis in this case or that he failed to meet the standard of care.

There was a divergence in the evidence surrounding the general pathologist’s diagnosis in the patient’s case.  The senior pathologist opined that the general pathologist arrived at an incorrect diagnosis and stressed that she could not even determine how he arrived at his conclusions because he failed to describe his microscopic findings in the pathology report.  The reviewing pathologist, on the other hand, found the general pathologist’s diagnosis to be more appropriate than the senior pathologist’s.

The Board was faced with two equally credible experts who arrived at differing views after reviewing the same slides on which the general pathologist based his diagnosis.  This fact highlights other testimony at the hearing describing pathology as a discipline in which two similarly trained pathologists can disagree on a diagnosis without either violating the standard of care. It leads the Board to the conclusion that the state failed in its burden to prove the general pathologist failed to meet the appropriate standard of care in the patient’s case or that he engaged in practice harmful or detrimental to the public.

The absence of microscopic findings in the patient’s case is concerning. The Board urges the general pathologist to exercise more care and attention in the communication of his findings.

For other various allegations, the Board judged the general pathologist’s conduct to be below the minimum standard of competence given (his/her) lack of professional competency and practice that was harmful or detrimental to the public.  The general pathologist was warned that such practice in the future may result in further disciplinary action against his medical license.

For other various allegations, the Board ordered the general pathologist to arrange in the auditing of 5% of his cases by outside pathology laboratory approved by the Board and ensure that the auditing entity submits a report to the Board on a quarterly basis.  He was also ordered to obtain a consultation with a board-certified dermatopathologist in all suspected melanoma cases and author a paper discussing the diagnostic criteria for well-differentiated squamous cell carcinoma and keratoacanthoma in vulvar tissue.

State: Iowa

Date: June 2017

Specialty: Pathology

Symptom: N/A

Diagnosis: Dermatological Issues

Medical Error: No error found

Significant Outcome: N/A

Case Rating: 2

Link to Original Case File: Download PDF

On 6/3/2013, a 67-year-old female presented to a pain management specialist for treatment of her previously diagnosed hypothyroidism.  The pain management specialist prescribed the patient 65 mg of Nature-Throid daily and drew blood for lab tests.  Each 65 mg Nature-Throid medication consists of 38 mcg of levothyroxine and 9 mcg of liothyronine.  The results of the patient’s blood tests showed normal TSH levels, normal T4 levels, and slightly elevated T3 levels.

On 6/18/2013, the pain management specialist increased the patient’s prescription for Nature-Throid to 130 mg daily.  The results of the patient’s blood tests did not justify increasing the dosage of Nature-Throid prescribed to the patient.  A reasonably prudent physician would only have increased the dosage of Nature-Throid prescribed to the patient with justification.  The pain management specialist did not document justification for increasing the dosage of Nature-Throid prescribed to the patient.  The blood tests did not justify prescribing the 130 mg of Nature-Throid daily.  A reasonably prudent physician would have waited for the patient’s hormone levels to properly balance and reach equilibrium before altering the dosage of Nature-Throid prescribed to the patient.

On 7/16/2013, the pain management specialist increased the patient’s prescription for Nature-Throid to 195 mg daily.  A reasonably prudent physician would not have altered the dosage of Nature-Throid prescribed to the patient without having ordered blood tests for the patient.  The pain management specialist did not document justification for increasing the dosage of Nature-Throid prescribed to the patient.  A reasonably prudent physician would have waited for the patient’s hormone levels to properly balance and reach equilibrium before altering the dosage of Nature-Throid prescribed to the patient.

On 7/16/2013, the pain management specialist informed the patient that he was increasing her dosage of Nature-Throid based on her body temperature.  A reasonably prudent physician would not have increased the dosage of Nature-Throid prescribed to the patient based on the patient’s body temperature.  Also, a reasonably prudent physician would have ordered blood tests for the patient, and he did not order or document ordering any blood tests for the patient.

The Board issued a letter of concern against the pain management specialist’s license.  The Board ordered that he pay a fine of $5,000 against his license and pay reimbursement costs for a minimum of $5,857.09 and not to exceed $7,857.09.  The Board also ordered that he complete a records course and complete ten hours of continuing medical education in endocrinology and complete a course in quality assurance consultation/risk management assessment.

State: Florida

Date: June 2017

Specialty: Pain Management, Endocrinology

Symptom: N/A

Diagnosis: Endocrine Disease

Medical Error: Improper medication management

Significant Outcome: N/A

Case Rating: 1

Link to Original Case File: Download PDF

On 1/15/2010, a 61-year-old female underwent an epidural injection.  Following the procedure, she complained of sharp pain in the lower extremities, followed by sensory and motor function loss below the T10 and T11 level.  The patient was transferred by ambulance to the emergency department.

A thoracic and lumbar MRI was performed and interpreted by a radiologist.  The final report for the lumbar spine states “Mild desiccation and degenerative changes of the disc but no disc bulge or herniation is noted.”  His final report of the thoracic spine demonstrates “normal MRI of the thoracic spine…A repeat study of the thoracolumbar spine is recommended without contrast infusion in both projections to better evaluate this area as this is on the edge of the study on the current images both lumbar and thoracic is not well delineated.”  Although the images were suboptimal, the epidural hematoma of the lower thoracic spine was evident in the axial images.

On 1/19/2010, a repeat MRI was performed.  The radiologist interpreted the MRI stating there is “abnormal signal focus demonstrated in the spinal canal from approximately the T10-T11 disc space inferiorly through the T12-L1 disc space located mostly in the posterior and posterolateral aspect of the spinal canal displacing the cords slightly anteriorly and causing a slight mass effect on the cord and subarachnoid sac.  This is consistent with a subdural or epidural hematoma.”

The Board judged the radiologist’s conduct as having fallen below the standard of care given failure to observe and document all pertinent findings on diagnostic imaging studies, failure to discuss findings requiring urgent treatment with the referring physician, failure to diagnose the abnormality found on MRI, and failure to document his discussion with the referring physician regarding the abnormality on MRI.

A public reprimand was issued against the radiologist.

State: California

Date: June 2017

Specialty: Radiology, Emergency Medicine

Symptom: Extremity Pain, Numbness, Weakness/Fatigue

Diagnosis: Spinal Injury Or Disorder

Medical Error: False negative, Failure of communication with other providers, Lack of proper documentation

Significant Outcome: N/A

Case Rating: 3

Link to Original Case File: Download PDF

On 5/8/2014, a 74-year-old female presented to an internist for the purpose of establishing care.  The patient had multiple medical problems, including diabetes, end-stage renal disease, and recurrent C. difficile infections.

At all times pertinent to this complaint, the patient was undergoing chronic hemodialysis treatment.

On 6/10/2014, the patient presented to the internist for a follow-up visit.  The internist prescribed 600 mg tablets of gabapentin to the patient to treat her diabetic neuropathy.  The patient’s prescription directed her to take the 600 mg of gabapentin twice daily, totalling 1200 mg of gabapentin per day.

On 6/14/2014, after taking her prescribed dosage of gabapentin, the patient lost control of her leg muscles and fell, resulting in a fracture of the T12 vertebrae in her back.

The prevailing professional standard of care required the internist to prescribe the patient a dosage of gabapentin not to exceed 150 mg per day, due to her end-stage renal disease.  The internist prescribed the patient an inappropriate and/or excessive dosage of gabapentin.

According to the internist, he verbally instructed the patient and/or her family members to modify the gabapentin prescription.

The internist failed to document and/or accurately document the alleged verbal instruction to the patient and/or her family members to modify the patient’s gabapentin prescription.

The Board issued a letter of concern against the internist’s license.  The Board ordered that the internist pay a fine of $5,000 against his license and pay reimbursement costs for the case at a minimum of $30,433.57 and not to exceed $32,433.57.  The Board also ordered that the internist complete a medical records course and complete five hours of continuing medical education in clinical pharmacology and drug dosing.

State: Florida

Date: June 2017

Specialty: Internal Medicine, Nephrology

Symptom: Weakness/Fatigue

Diagnosis: Drug Overdose, Side Effects, or Withdrawal, Diabetes, Neurological Disease, Spinal Injury Or Disorder, Renal Disease, Fracture(s)

Medical Error: Improper medication management, Accidental Medication Error, Lack of proper documentation

Significant Outcome: N/A

Case Rating: 3

Link to Original Case File: Download PDF