Products of Conception Guidance

Yes. The likelihood of significant missed pathology from a gross-only evaluation of first trimester POC specimen is minimal. The procedural clinician should examine the POC grossly in the procedure room to confirm pregnancy and to exclude possible abnormality. Any POC specimen that is grossly abnormal or lacking identifiable villi should be sent for examination by a pathologist. Any POC with a suspected genetic or fetal abnormality or from recurrent pregnancy loss should be examined by a pathologist. Institutional policies that specify exemptions for tissue examination by a pathologist are recommended to ensure clarity and consistent tissue/specimen handling.

No. If a first-trimester POC specimen is determined to require examination by a pathologist for the reasons stated above, a full gross and microscopic diagnosis is recommended.

Yes. If no congenital abnormalities are suspected and no gross congenital abnormalities are identified by the procedural clinician, these specimens can reasonably be exempted from pathologist examination. Fetuses with suspected genetic abnormalities or external signs of congenital abnormalities should be examined by a pathologist, as this examination may inform the management of a subsequent pregnancy; sampling of tissues for genetic/molecular testing may be warranted.

Yes, in some cases. The presence of an identifiable fetus makes a complete molar gestation extremely unlikely (except in the setting of an extremely rare twin gestation). However, the CAP recommends that pathologists examine any fetus with suspected congenital anomalies. The examination may include both a gross and microscopic diagnosis and may inform on the management of a subsequent pregnancy. However, the determination to perform a pathologic evaluation and the extent of evaluation should, to the extent consistent with applicable law, respect the wishes of the parents.

No, however, pathologists should be mindful of the changing legal and social climate.

Traditionally, specific consent (in excess of the usual consent for pathologic evaluation for all procedural tissues) has not been required for the pathologic evaluation of POC or fetuses of less than 20-weeks’ gestation. However, this decision must be considered in light of evolving social sensitivities and legal climate. The CAP is aware of some institutions voluntarily requiring specific parental consent forms for the pathologic examination of POC. These institutions offer a choice of no examination, gross evaluation only, or a gross and microscopic evaluation with or without restrictions. Institutions vary with respect to the gestational age for which specific parental consent is required and this ranges between >11 to >16 weeks’ gestation. As states consider fetal personhood laws, rules on specific consent may change. As such, it is crucial that pathologists consult with legal counsel, as needed, to ensure compliance with all applicable laws and guidance.

The required disposition varies by state. Discussion with legal counsel is important to ensure compliance with evolving law, regulations, and guidance. Traditionally, fetuses up to 20 weeks gestation and less than 350 grams have been dispositioned in a manner identical to other tissue specimens. However, some states have instituted burial or cremation requirements for POC and fetal tissues. Consultation with institutional counsel and a thorough understanding of these legal requirements are critical when creating institutional specimen-handling policies and procedures. Some institutions report voluntarily instituting parental consent requirements for disposal of POC tissues. Specific gestational ages may be established for this requirement and range between >11 to >16 weeks’ gestation. As funeral services impose an additional cost on laboratories, institutions with specific requirements may require parents to cover the cost for fetal burial, if not required by law and when parents refuse standard medical disposition procedures.

Such dispositioning may be legal in certain states. It is important to create institutional policies, with consultation from legal counsel to ensure appropriate dispositioning in accordance with state laws. Further, collaboration with clinicians and patient and family advisory councils may be valuable in creating policies that consider social sensitivities. As there have been isolated reports of parental distress from a change of heart after the 14-day window has elapsed, some institutions have created policies requiring retention of fetal tissues, especially second-trimester gestations, for an extended time period before disposition.

Partial molar gestations are often associated with fetal tissues and are no different from losses of pregnancy with aneuploid fetuses or with congenital abnormalities. Handling of these should comply with all legal requirements—which can vary significantly by state–for the handling of fetal tissues. However, complete molar gestations do not have a maternal complement (these are pure androgenetic diploids) and, therefore, cannot reasonably be considered fetal tissues. Thus, the CAP recommends that these tissues be dispositioned as routine surgical pathology specimens. However, complete molar pregnancy specimens are rare. As such, it can be advisable for laboratories to implement a single policy for the disposition of all POC, with no exceptions for rare types of specimens, especially considering the legal requirements for the disposition of fetal tissues.

The CAP recommends complete and accurate reporting for all examined tissue specimens. Ensuring accurate language is also important to avoid confusion and undue parental distress. The following are some considerations.

1. Consider using the term “embryonic/fetal tissues” for POC in the first trimester. Developmentally, a conceptus is an embryo at less than eight completed weeks of development (10 weeks gestational age by dates from the last menstrual period) and therefore the listing of embryonic tissues as “fetal tissue” has the potential to cause confusion. The CAP prefers the terminology of “embryonic/fetal tissue” for early gestations.
2. Gestational age should be estimated on embryonic/fetal tissues when possible. Estimation of gestational age is important to clinical decision-making. Foot length has been shown to be a sensitive and accurate measure of gestational age even in the setting of intrauterine growth restriction especially through the early second trimester. The CAP thus recommends documenting specific gross specimen measurements. The CAP recommends that laboratories evaluate internal policies to ensure process control for foot-length measurement. The CAP recommends using current data tables for gestational age such as those by Drey et al. and/or Hansen et al.^1,2 Older tables, such as those originally created by Dr. Streeter in the 1920s, may overestimate gestational age for as many as 30% of gestations. Pathologists may also find correlation with ultrasonographic assessments useful.
3. Pathologists should add an explanatory comment to endometrial curetting samples that contain benign bone tissues to avoid confusion. Osseous metaplasia in the endometrium, although rare, is reported and is not indicative of pregnancy in the absence of other gestational tissues.
4. Pathologists may want to add an explanatory comment when reporting on placental site plaques and nodules to avoid confusion. These are evidence of a remote rather than a recent pregnancy.
5. Pathologists should thoroughly familiarize themselves with state reporting requirements for pathologies considered “complications of abortion.” Different states have significantly different laws, regulations, and guidance on obligations to report complications of abortion. Coordination with institutional structures, including legal counsel, is important to ensure accurate reporting, as some of these pertain to subsequent pregnancies.

In any of these circumstances, consultation with institutional legal counsel is recommended.

Coding for POC is dependent on procedure. Elective termination of pregnancy (abortion, induced) is assigned a current procedural terminology (CPT) code of 88304 while spontaneous or missed pregnancy losses are assigned an 88305 code with attendant differences in remuneration. Accurate coding to the highest level of specificity is required by various regulatory authorities and the CAP supports complying with these requirements.

Pathologists, especially those in hospital settings, should work with their hospital administrations to ensure that patient-requested restrictions on the sharing of reproductive information with subsequent health providers apply to pathology reports. Pathology reports have the potential to reveal information against patient wishes. For example, the categorization of pathology reports as “laboratory test results” and not as “obstetric information” could result in the sharing of reproductive information that the patient did not want shared. In all events, pathologists should comply with all legal requirements—including but not limited to HIPAA—on the sharing of patient information.