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Based on interview and record review, the facility failed to follow facility's policy and procedure for Universal Protocol to conduct a time out (the surgical team's short pause, just before a procedure, to confirm that they are about to perform the correct procedure on the correct body part of the correct patient) when there was no evidence documented of the time out done for three of 30 sampled patients (Patient 1, Patient 11, and Patient 12).

This deficient practice had resulted to Patient 1 having the wrong breast biopsied (left breast), and had the potential for Patient 11 and Patient 12 to have the breast biopsy on the wrong site The deficient practice had the potential to
result in infection and pain from a biopsy of the wrong site patient undergoing invasive procedures (a medical test commonly performed by a surgeon, interventional radiologist, or an interventional cardiologist).

Findings:


1. During an interview on 8/31/22, at 1:10 p.m., with Assistant Director, Diagnostic Imaging (ADDI), ADDI stated, the ultrasound technologist (MRT 2, specializes in the imaging of human anatomy for diagnosis and treatment) allowed Patient 1 to disrobe herself (Patient 1) for a stereotactic (X-ray/radiology-guided) right breast biopsy (sampling of tissue from the body for closer examination) and assisted her (Patient 1) to lie face down on the procedure table. The ADDI stated, the calcifications (calcium deposits within breast tissue that appear as white spots or flecks on a mammogram [examination of the human breast for diagnosis and screening]) in Patient 1's bilateral breasts mirror each other. The ADDI stated, both the radiologic images and actual, physical site on Patient 1's body should have been verified during time-out (healthcare team's short pause, immediately before the procedure, to confirm the correct procedure was to be performed on the correct body part of the correct patient). ADDI stated, there was no documentation that a time-out was performed in Patient 1's medical records. The ADDI stated, Patient 1's left breast was biopsied instead of the right breast, and the error was discovered during a mammogram after the procedure was completed.

During an interview on 9/1/22, at 3:07 p.m., with Lead Radiologic Technologist IV (LRT), LRT stated, marking the biopsy site on the anterior (front) side of the patient and performing a time-out are standard procedures in the facility's Diagnostic Breast Exam department.

During an interview on 9/2/22, 11:40 a.m., with Mammography, Radiologic Technologist II (MRT 1), MRT 1 stated, she (MRT 1) witnessed Patient 1 sign an informed consent (attestation that a patient received sufficient information before making their own free decisions about their medical care) for a right breast biopsy. MRT 1 stated, she (MRT 1) stayed behind Mammography, Radiologic Technologist I (MRT 2) during the procedure. MRT 1 stated, MRT 2 has been training in the stereotactic room for two weeks and it was her (MRT 2) first time taking the lead of a procedure. MRT 1 stated, MRT 2 allowed Patient 1 to disrobe her (Patient 1) left sleeve and position her left breast in the hole on the procedure table. MRT 1 stated, Patient 1's hospital gown was hanging, and she (MRT 1) assisted Patient 1 in tucking the left sleeve in her (Patient 1) pants. MRT 1 stated, the healthcare team used the radiologic images to verify the site and that it is unusual to have the same calcifications in both breasts. MRT 1 stated, staff did not mark the biopsy site prior to the incident and relied on radiologic images since patients lie face down on the procedure table.

During an interview on 9/2/22, at 1:40 p.m., with Director, Risk Management (DRM), DRM stated, MDs lead the diagnostic breast exam department.

During a review of Patient 1's "Mammogram Screening," dated 5/11/22, the "Mammogram Screening" indicated, "There are grouped calcifications in the right breast at 12 o'clock middle depth."

During a review of Patient 1's "Consent to Operation," dated 5/31/22, the "Consent to Operation" indicated, Patient 1 signed for a right breast image biopsy with tissue marker placement."

During a review of Patient 1's "MD Note," dated 5/31/22, the "MD Note" indicated, "Stereotactic guided biopsy left breast with marking device inserted and post (after) digital mammographic imaging and radiographic specimen (sample) imaging". The "MD Note" indicated, "This was not the original intended side for biopsy and was biopsied in error."

During a review of facility's policy and procedure (P&P) titled, "Universal Protocol," last revised on 2/7/22, the P&P indicated, "1.0 Policy Statement, 1.1 The Universal Protocol (UP) process will be used for all patients undergoing operative or invasive procedure. The Universal Protocol is a risk reduction strategy that is designed to ensure correct patient, correct procedure, correct site, and correct side for all operative or invasive procedures." The P&P also indicated, "5.3 Mark the Surgical/Procedure Site, 5.3.1 All procedure sites must be marked regardless of which setting the procedure is taking place." The P&P further indicated, "5.4 Time Out, 5.4.7 Conduct a Time Out that includes verbal agreement by the team of the following elements: 5.4.7.3 Correct site, 5.4.7.4 Correct side, 5.4.7.5 Site mark is visible after prep & drape (cover)."

2. During a concurrent interview and record review on 9/2/22, at 3:20 p.m., with Assistant Manager, Diagnostic Imaging (AMDI), Patient 11's "MD Note" dated 6/6/22 was reviewed. The "MD Note" indicated, "The skin was prepped in the usual manner. Local anesthetic (numbing medication) was administered to the access site. A biopsy needle was placed adjacent to the abnormality under ultrasound guidance." AMDI stated, there was no documentation that a time-out was performed.

During a review of Patient 11's "Mammogram Screening," dated 5/12/22, the "Mammogram Screening" indicated, "There is an asymmetry (uneven) in the left breast middle depth medial region seen on the craniocaudal view (projections) only."

3. During a concurrent interview and record review on 9/2/22, at 3:25 p.m., with AMDI, Patient 12's "MD Note" dated 6/7/22 was reviewed. The "MD Note" indicated, "The skin was prepped in the usual manner. Local anesthetic was administered to the access site. A biopsy needle was placed adjacent to the abnormality through an introducer device under ultrasound guidance." AMDI stated, there was no documentation that a time-out was performed.

During a review of Patient 12's "Mammogram Screening," dated 5/16/22, the "Mammogram Screening" indicated, "There are grouped punctuate calcifications in the right breast at 11 o'clock middle depth. There also is a cluster of grouped punctuate calcifications in the right breast at 12 o'clock middle depth."

During a review of facility's policy and procedure (P&P) titled, "Universal Protocol," last revised on 2/7/22, the P&P indicated, "1.0 Policy Statement, 1.1 The Universal Protocol (UP) process will be used for all patients undergoing operative or invasive procedure. The Universal Protocol is a risk-reduction strategy that is designed to ensure correct patient, correct procedure, correct site, and correct side for all operative or invasive procedures." The P&P also indicated, "5.3 Mark the Surgical/Procedure Site, 5.3.1 All procedure sites must be marked regardless of which setting the procedure is taking place." The P&P further indicated, "5.4 Time Out, 5.4.7 Conduct a Time Out that includes verbal agreement by the team of the following elements: 5.4.7.3 Correct site, 5.4.7.4 Correct side, 5.4.7.5 Site mark is visible after prep & drape (cover)."