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SOUTH COUNTY HOSPITAL INC 100 KENYON AVE WAKEFIELD, RI 02879 March 1, 2011
VIOLATION: SCOPE OF RADIOLOGIC SERVICES Tag No: A0529
Based on record review, staff interviews, review of the hospital policies entitled "Needle Localization" and "Surgical Counts", and review of the manufacturer's recommendations entitiled "Kopans Breast Lesion Localization Needles", it was determined that the hospital failed to provide services that meet the needs of the patient in accordance with accepted standards of practice, related to a needle localization procedure, for relevant sample patient ID #4.

Findings are as follows:

A review of the hospital mammography protocol entitled "Needle Localization", under Item #10 states:

"When proper position is verified by the Radiologist, the needle portion of the localization needle is removed by the Radiologist, leaving the hook wire portion in the breast".

Under item #12, it states:

"The technologist will then fasten the hookwire to the skin surface, first laying a sterile 4 x 4 to skin, taping it and placing the wire on top of that, then placing another 4 x 4 over the wire. Do not put any tape on the wire itself".

This is in conflict with the manufacturer's guidelines for the product entitled "Kopans Breast Lesion Localization Needles" which states under "Precautions":

"Following placement of the hookwire, the portion protruding outside of the breast should be bent and taped to the skin to prevent inadvertent movement".

Under "Instructions for Use", item #6 states:

"Bend the hookwire protruding from the breast and tape flat to the skin".

Further, a review of the "Archives for Surgery, Volume 123 Number 6, June 1988, Complications of Needle Localization of Foreign Bodies and Nonpalpable Breast Lesions" states:

"Recommendations to minimize the incidence of these complications and their sequelae include (1) bending the hookwire 90 degrees at the skin surface following localization..."

A review of another hospital policy entitled "Surgical Counts" under item #12 states:

"A diligent search of sterile fields, trash and floor is made for missing items(s). An X-ray is taken if items are not found".

A review of the clinical record for patient ID #2 revealed an elective hospital admission for a right breast lumpectomy with axillary node dissection on 9/7/10. The patient was sent to Diagnostic Imaging prior to the procedure for a right breast needle localization under mammography, as well as a sentinel node localization in Nuclear Medicine.

A review of the Diagnostic Imaging report for the mammography needle localization revealed that "wire localization of the biopsy site indicated by the presence of a biopsy clip in the upper outer quadrant of the right breast was performed. This had to be performed twice as following the initial wire localization, prior to surgery, after having left the department, the intial wire was dislodged".

During an interview on 3/1/11 at 9:00 AM with the Risk Manager, it was reported that after the initial needle localization had been completed, the Radiology Technician had applied a dressing over the wire in place, and secured the dressing with tape. The patient was then transported to Nuclear Medicine for the sentinel node localization. When this was completed, the patient was transported to the Ambulatory Care Unit holding area. The patient was brought into the Operating Room Suite by stretcher and transferred to the Operating Room table. When the Surgeon removed the dressing, there was no wire. A search of linens and the floor resulted in no wire found. "The presumption was that the wire had fallen out". Although the wire was not located, a chest X-ray was not done for the missing item per the hospital policy.

The surgery was delayed, and the patient returned to Diagnostic Imaging for a new wire placement under mammography. The surgery was then completed without complication. On 9/25/10, the patient presented to the Emergency Department with complaints of high back pain. Upon physician examination, "a biopsy marking wire approximately 6 inches long" was protruding from the patient's back, and was removed under local anesthetic. The patient tolerated the procedure well. It was determined that this wire had migrated from the 9/7/10 procedure.

During an interview on 3/2/11 at 10:40 AM with the Surgeon, it was reported that the Radiologist was made aware that the "wire had fallen out", but there was no communication that the wire had not been found. "An x-ray was not thought of as the repeat mammogram should have shown any wire migration".

During an interview on 3/1/11 at 11:30 AM with the Chief of Radiology, he reported that once the wire is advanced and is in place with the needle localization, and the Radiologist is satisfied with the position, moving the wire "puts the patient at risk". The protocol is to place a guaze under and over the wire, and coil the wire. The guaze is taped, but the wire is not taped. The manufacturer's recommendations are not followed, as this can "interrupt the outcome". There is also a question as to "where to bend the wire" per the manufacturer.

The Chief of Radiology did report that the wire was not seen in the visual field with the repeat mammogram. The Radiologist and the Techinician had reported that they were aware that the wire had fallen out, but were not aware that it had not been found. "They should have asked to see it. A chest X-ray should have been done if the wire had not been found".

During an interview on 3/1/11 at 10:00 AM with the Radiology Technician, it was reported that the hospital policy was followed when a guaze was placed under the wire, secured with tape, the wire was coiled, another guaze was placed over the wire, and this guaze was also secured with tape. No tape is used directly on the wire.

It was determined that although the hospital has a policy in place for needle localization, this policy does not follow the manufacturer's recommended guidelines. In addition, there was poor communication between the Surgeon and the Radiologist, resulting in the Radiologist not being aware that the dislodged wire had not been found. This resulted in a chest Xray not being done, per hospital policy.