Surgery: Foreign Object Retention
The retention of a foreign object within a patient’s body cavity or incision after an operation is a continuous source of avoidable litigation for surgeons and the facilities in which the operations are performed.
A typical example of these cases involved a 36-year-old female who underwent an abdominoplasty by her plastic surgeon. An indurated area was noted postoperatively, and serous drainage from the incision developed. Spontaneous resolution did not occur as expected; a retained sponge was subsequently discovered and removed. In such cases, there is no defense against allegations of negligence, delays in diagnosis and treatments, unsightly scars, and damages sought for patients’ additional pain and expenditures.
From 1985 to 1998, the incidence of objects being left within surgical patients has occurred at a steady rate of more than 40 per year. Specifically, 601 such cases have involved hospitals, surgical clinics, and physicians insured by The Doctors Company during that time period. The incidents have encompassed all medical specialties, and the variety of retained foreign bodies has included 4x4 and laparotomy sponges, needles, hemostats, broken or dislodged pieces of equipment—even a towel.
It is acknowledged by medical professionals that the operating surgeon should not be responsible for maintaining an account of objects that are admitted to or removed from the operative field. That responsibility belongs to the medical facility where the procedure is performed and to its employees, the circulating and scrub nurses.
Unfortunately, this acknowledgment has not afforded surgeons immunity from liability. Surgeons are invariably included in legal actions that follow the discovery of retained foreign bodies. To help protect themselves from liability, prudent surgeons should adopt four preventive measures:
- Exclusively perform procedures in facilities with established written protocols for counting sponges, sharps, and instruments that meet Association of Operating Room Nurses (AORN) standards and/or are accredited by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO).
- Make certain that counts are performed and reported to surgeons as correct at the conclusion of every surgical procedure.
- Include one phrase—without fail—in every operation report: The sponge and needle counts were reported to be correct.
- Maintain a healthy level of suspicion that complicated wound healing might be caused by a retained foreign body.
Operating Room Protocols
At a minimum, operating room protocols for counting should include the following:
Sponges and Sharps—An initial count of all items made before the surgical procedure serves as a baseline for subsequent counts. Additional counts are made:
- Whenever more sponges or sharps are added to the sterile field
- Upon relief of either the scrub or circulating nurse
- Before body cavity closure
- Before completion of the operation
In each situation, items should be counted audibly and concurrently as the scrub and circulating nurses view each item individually. In addition, all items should remain in the operating room until the conclusion of surgery. Sponges that are used for packing, drains, and similar devices should be documented in the intraoperative record, and all sponges should be x-ray detectable, with the exception of those used for dressings.
Instruments—Standardized instrument sets should be established with specified type and number of instruments contained therein. Initial, subsequent, and closing counts are conducted in the same manner used for sponges. All instruments remain in the operating room and should be accounted for prior to preparation of the room for the next patient. Disassembled or broken instruments should be accounted for in their entirety. A written approved policy may be established to allow for deleting subsequent counts of items that have no significant risk of being left within the operative site.
Documentation—An intraoperative record should be maintained by the circulating nurse that includes, but is not necessarily limited to:
- Types of sponges, sharps, and instruments
- The number and timing of counts
- Actions taken if any count discrepancies occur
- The rationale for any counts not performed or completed (determined to be in correct accordance with protocol requirements)
Surgeons should only perform surgeries in facilities that adhere to acceptable protocols. Such protocols must be written and readily available in the practice setting. Surgeons who perform surgeries in facilities that do not have mandatory safeguards for minimizing the chance of a foreign body being left within a patient should be prepared to accept sole responsibility and full liability for any untoward incidents.
The All-important Phrase
The established surgical practice is for circulating nurses to inform surgeons at or before the conclusion of operations whether all counts are correct.
If such information is not spontaneously volunteered by a nurse, it is the surgeon’s responsibility to ask, “Were the counts correct?” If the nurse’s answer is not an unequivocal “yes,” the surgeon must:
- Immediately halt completion of the procedure and have anesthesia maintained until a correct count is verified.
- Take an intraoperative x-ray if the procedure has been completed to ensure that any unaccounted foreign bodies have not been left within the patient.
In addition to receiving assurance from the nurse(s) that counts are correct, it is crucial for surgeons to include, “The sponge and needle counts were reported to be correct,” in their operation reports. Inserting this phrase, preferably near the end of the report, reinforces that the surgeon fully relied on attending scrub and/or circulating nurses to maintain an accurate account of sponges, sharps, and instruments—and to prevent any items from being left in the patient.
Undoubtedly, surgeons will continue to be included in lawsuits that follow the discovery of foreign objects within patients. To help avoid liability, surgeons must be certain that: 1) medical facilities where they perform surgeries are accredited by AORN, JCAHO, the Accreditation Association for Ambulatory HealthCare, Inc. (AAAHC), the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), or similar accrediting agencies; 2) preventive protocols are being carefully followed; and 3) all counts of sponges, sharps, and instruments are correct, as reported by attending nurses. Surgeons who fail to adopt any of these measures increase their responsibilities for untoward incidents and greatly relieve medical institutions and employees from the liability associated with retention of any foreign objects within patients.
Surgical facilities that are not hospital based may experience similar lapses in sponge, sharps, and instrument counts and are not exempt from adhering to the guidelines set forth. Although surgical procedures may be shorter at these facilities, they are at no less risk for having incorrect counts.
Including the phrase, “The sponge, sharps, and instrument counts were reported to be correct,” is often sufficient to: 1) place responsibility for a mishap squarely on a medical facility and its employees; 2) greatly mitigate the degree of responsibility the surgeon bears; and 3) absolve a surgeon from claims of negligence.