Requests for Pathology Specimens: Medical and Legal Guidelines
When you receive requests for pathology specimens—original tissue slides, blocks, or cytology smears—remember that these are irreplaceable materials that may become evidence in a malpractice claim. Failure to follow the steps outlined in this article may result in the loss or destruction of critical information needed for claims involving the laboratory, practice, or individual physician and might also prompt subsequent claims for spoliation of evidence.
Pathology specimens are the property of the laboratory to which they are submitted. Pathologists are legally obliged to use such materials for patient benefit and have an added responsibility to maintain them in a safe and secure environment in accordance with federal and state privacy laws and standards of care.
It is necessary upon receipt of any inquiry to separate requests for specimens into medical and legal categories. Knowing how to respond will help safeguard these specimens and minimize your potential liability exposure. All requests require the written authorization of the patient, a valid subpoena, or other court order. You are strongly encouraged to consult with your personal or corporate counsel or The Doctors Company designated patient safety risk manager to ensure that the inquiry complies with legal requirements and to obtain guidance on preparing an appropriate response.
Medically Motivated Requests
Medical requests may be generated for continuity of care issues or be necessary for follow-up of medical conditions. Patients may relocate or choose a new doctor who may want (or need) to confirm a previous diagnosis or other medical history details. Specialty referrals to another medical center constitute yet another of the need-to-know scenarios.
However, even when a request appears to be purely medical, you must take steps to preserve original, irreplaceable materials—to the extent possible—in the event that providing the requested information might lead to a claim or a lawsuit against you or another clinician.
If only histopathology slides are requested, prepare recuts, and label them as such to avoid any confusion with the original slides in the event of litigation. Examine the slides for comparability. If they are comparable, send only the recuts and a copy of your report. Retain the original slides. Document the chart with the request and a written notation indicating how you responded to the inquiry.
If your review of the original slides or recuts reveals an error by you or a colleague, you should prepare an amended report. That report should be sent to the original treating physician and to the requesting doctor, along with a letter of explanation. Do not be defensive; merely state the facts objectively. A personal phone call to the original doctor and to the requester is recommended, and such calls should also be documented and dated—preferably in the amended report. Notify The Doctors Company immediately about the possibility of a potential claim when an amended report is issued.
When responding to medically motivated requests, always follow the procedures described below:
- Include a cover letter specifically indicating what has been sent. Your letter may include a generic checklist of the various materials that are apt to be requested. Leave a space at the bottom for special instructions or comments. See our sample forms for help in drafting a cover letter.
- State whether the requester may keep the recuts or if he or she should return them.
- Place a copy of your cover letter in a tickler file, and devise a follow-up system to ensure that any materials you want back are in fact returned. Maintaining such a procedure is well worth the effort in order to help guarantee the integrity of your records and demonstrate due diligence in the event that a claim subsequently arises.
- Request a copy of any reports issued by the reviewing pathologist. If there is a serious disagreement between you and the reviewing pathologist, inform The Doctors Company immediately, and consider sending the case to an expert consultant for another opinion in consultation with The Doctors Company.
If original slides must be sent because recuts are not comparable, or if irreplaceable items such as cytology smears are requested, you have no choice in purely medical situations but to comply. For original or irreplaceable items, follow these additional steps:
- Request the prompt return of all original or irreplaceable items.
- Discuss the process with the requesting party in advance. Document the discussion.
- Prepare a written agreement for the requesting party to sign. The agreement should acknowledge that the material is the property of the laboratory or medical practice and that it will be returned promptly once the external review is complete.
- Use a courier for transport whenever possible.
- Obtain a written receipt of the transferred materials from the individual or entity (such as FedEx or UPS) that transports the specimens.
Legally Motivated Requests
You will periodically receive legal requests from attorneys for slides, fixed tissue, or blocks. Requests for specimens for legal purposes may be a simple letter or a letter accompanied by a subpoena or other court order. All requests based only on an attorney-generated correspondence should be accompanied by the patient’s written authorization to release. Although not required when the request derives from a court order, it is recommended that the practice contact the patient to ascertain agreement with the inquiry. Documenting the patient’s response is an important step in safeguarding privacy rights.
It is reasonable to confer with the attorney to ascertain the purpose of the request and to determine which specimens are actually needed. If it is possible to do so, follow the guidelines outlined previously for medically motivated requests.
If the attorney insists on the original slides, we recommend that you notify The Doctors Company for further guidance. You can then inform the attorney that the requested materials cannot be recut or that only the original slides are on file. State that the specimens will be made available for examination by a designated expert on laboratory premises under your supervision only upon written request and on a previously agreed date, time, and location. For legal requests, original materials or irreplaceable specimens should be released only pursuant to a court order. When in doubt, call The Doctors Company.
Subpoena in Cases in Which a Formal Lawsuit or Claim Has Been Filed
Whether you or another clinician is named in a claim or lawsuit, do not send any materials without first obtaining the concurrence of The Doctors Company. We (or your assigned attorney, if you are a named party) will ascertain whether recuts of blocks will suffice. If that is the case—and if the plaintiff’s attorney agrees—recuts can be prepared and sent as outlined earlier.
If the plaintiff’s attorney insists on original slides or if only the original slides are available, your appointed attorney will file a motion in court to limit discovery and will argue for an examination of slides or other materials by the plaintiff’s expert on your premises and under your supervision to help maintain the integrity of the materials and avoid a claim of spoliation of evidence.
In this scenario, two possibilities arise: 1) You receive a favorable decision from the court, and you need not send materials; they will be examined on your premises; or 2) the court orders you to turn over the materials, and you must comply. In the latter instance, if original slides or other irreplaceable preparations are then broken or lost, you will operate under the court’s protection from charges of spoliation of evidence and in accordance with the legal advice of retained counsel.
Even when the court orders the examination to take place on your premises, the plaintiff’s expert may want deeper cuts, more tissue submitted, or special studies performed. In any of these instances, you may offer to prepare the additional materials and have them examined on your premises, but do so only in consultation with The Doctors Company and your attorney (if one has been assigned).
It is possible that the plaintiff’s lawyer may go back to court, demanding blocks of tissue so that the plaintiff’s expert can perform additional examinations. If that happens, your attorney will oppose the demand and keep you updated as to the status of the process. Your subsequent course of action will depend on the second decision of the court. Again, if you are forced to turn over the materials, you will have the court’s protection in the event of damage or loss.
If the plaintiff’s attorney demands original slides, blocks, or other irreplaceable material during the interval between that demand and your attorney’s resistance to the demand, you should—in all histopathology cases—prepare recuts if there is sufficient residual tissue in the blocks to produce comparable slides.
Our current legal culture requires you to be aware that an apparently innocent request always has the potential to become a claim or lawsuit against you, either directly or as a result of the handling and production of the pathology materials being requested. If you have questions regarding requests for pathology specimens, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.