HospitalInspections.org

Based on record review and interview, the hospital failed to follow hospital policy and procedures regarding the administration of radioactive isotopes. As a result patient # 1 (a female of child bearing years) received a dose of radioactive iodine (I-131) without first being evaluated for pregnancy.

New York State Department of Health survey staff received a complaint on behalf of patient #1. Patient #1, a 24 year old female, presented to the Nuclear Medicine Service of the hospital for treatment with radioactive iodine on 07/01/2015. The complaint alleged that hospital nuclear medicine staff did not verify whether or not patient #1 was pregnant prior to administering radioactive iodine to her.

Findings:

Staff A, a nuclear medicine technologist (NMT) was interviewed regarding verification of pregnancy status in females who present for administration of I-131. Staff A stated on interview on 08/25/2015 at approximately 10:30AM that nuclear medicine department staff document patient information for female patients undergoing this nuclear medicine procedure on five different forms and that the completed forms are to be retained in the patient's medical record.
The forms are:

1) Patient Pregnancy Questionnaire (no revision date)
2) Patient I-131 radiation Safety Instructions (no revision date)
3) Consent to Use Radioistopes Nuclear Medicine (no revision date)
4) I-131 Quality Assurance Form (no revision date)
5) An untitled form to record side effects and complications of I-131 therapy (no revision date)

Staff A, a NMT, was interviewed regarding the implementation of nuclear medicine department policy when treating females of child bearing age with I-131. Staff A stated that prior to undergoing a nuclear medicine procedure, females of child bearing years are asked if they are pregnant and if they deny pregnancy they are given a form to sign. If there is a question of pregnancy status the patient is counseled by the NMT and a radiologist about receiving radiation. The decision to receive the radioactive iodine is left up to the patient. The NMT does not obtain an order from the patient's physician for a pregnancy test.

When reviewed during the site visit of 08/25/2015, patient #1's medical record lacked three of the five required nuclear medicine forms (#1, 3, and 5). Additionally, one of the two forms which was retained in the patient record was incomplete (#4); it did not document any information about the pregnancy status of the pregnant, what the results of the pregnancy test (if any) was, why a pregnancy test was not completed, and that no written consent for admisinstration of I-131 was on file in the medical record. There was a line drawn across the entire Patient Interview section of Form #4, the I-131 Quality Assurance Form. Form #4, the I-131 Quality Assurance Form was signed by a Nuclear Medicine Technologist and co-signed by the Radiation Safety Officer, a Radiologist.

Staff A was then interviewed regarding the medical record findings in Patient #1's chart. Staff A explained on interview that he did not complete the Patient Interview section of the "I-131 Quality Assurance Form" because the patient had signed the "Patient Pregnancy Questionnaire" indicating she was not pregnant. It was verified by both Staff A and with the Director of Medical Imaging that the signed "Patient Pregnancy Questionnaire" was not in the patient's medical record, nor did the patient have a pregnancy test at the hospital prior to undergoing the I-131 therapy.

Review of the Nuclear Medicine Policy #NM3a (effective date 1/10) conducted during the site visit indicates the following: "Women age 13-55 need a pregnancy test that same day or 48 hours prior to therapy administration and must also sign a "pregnancy questionnaire".