HospitalInspections.org

Based on interview and review of medical records, it was determined that the hospital failed to assure that Patient #1 received care in a safe setting. The hospital's failure to do so resulted in pain, fear and discomfort for Patient #1, and placed all patients who underwent injections in the Nuclear Medicine department at risk for the same, as well as for receiving inaccurate, incomplete and inconsistent care services.

Findings include:

Failure to Identify and Provide Interventions Regarding Patient Pain

The complainant stated that on April 12, 2012, Patient #1, who had been diagnosed with breast cancer, underwent injections into the right breast as part of the pre-surgery workup. The complainant stated that the patient was told by the Nuclear Medicine technologist that the hospital had a shortage of lidocaine, and the pharmacy had told the Nuclear Medicine staff that the lidocaine in the hospital was "not approved" for the procedure the patient was having.

The complainant stated that the technologist injected Patient #1 directly into her breast, which resulted in severe pain. The complainant stated that the patient was in so much pain, she kicked the pillows off of the table and told the technologist that it hurt so badly she did not know if she could tolerate the remaining 3 injections. The technologist reportedly acknowledged that the injections were painful, but told the patient to "lie still" and said if the patient did not have all 4 injections, her surgery would have to be canceled.

The complainant stated that the patient reported that the technologist did not offer to go get the radiologist, or other imaging personnel, to try and find a way to help the patient tolerate the procedure.

Review of the patient's medical record for the procedure confirmed that no lidocaine, or other medication which might alleviate pain, was used for any of the 4 injections around the patient's nipple.

On August 6, 2012, the Nuclear Medicine technologist who treated the patient was interviewed. The technologist stated that the radiologist was not involved in any portion of the patient's care on the day of the injection, nor was the Registered Nurse (RN) from interventional radiology. The technologist also recalled telling the patient that there was no lidocaine available due to a short supply of the drug.

The technologist stated that s/he remembered the patient and that the patient had been uncomfortable, but s/he did not think the discomfort was greater than any other patient experienced during that procedure. S/he did recall that the patient stated to her/him when the procedure was over that the patient would never go through that procedure again without lidocaine.

The technologist stated that s/he did not recall telling the patient to lie still, or telling the patient that her surgery would have to be canceled if she did not have all 4 injections, nor did s/he recall the patient kicking all of the pillows off of the table. S/he stated s/he did not recall the patient screaming, but s/he did recall that the patient had kicked her legs.

When asked why s/he had not asked for help, the technologist stated that s/he did not have specific guidelines on when and who to call for help, but for inpatients, s/he would call the patient's nurse. For outpatients (such as Patient #1), the technologist stated there were no specific guidelines.

The technologist stated that since the incident in question, the Nuclear Medicine staff had been informed that they could ask the RN in Interventional Radiology for assistance.

The Regional Director for Diagnostic Imaging was interviewed about the incident under investigation. The Director stated that s/he had met with the technologists to let them know what support was available to them, such as the RN in Interventional Radiology. The Director also stated that all policies and procedures for the Nuclear Medicine Services were under revision.

The Director stated that the pharmacy communicated directly with the technologists about the shortage of Lidocaine. Because the pharmacy did not communicate through leadership of the imaging department, imaging leadership was unaware of the situation with the shortage, did not know the medication was going to be restricted and did not subsequently have the opportunity to direct technologists on how to obtain the medication from other hospital department, such as Interventional Radiology.

The Director stated that the other 2 hospitals in the Franciscan network also did not routinely use lidocaine for the breast injection procedure that Patient #1 underwent.

The hospital's failure to assure that patients who were experiencing pain had their pain assessed by a practitioner qualified to assess pain and intervene on behalf of the patients, placed all patients at risk for unnecessary pain during procedures.

The hospital failed to assure the uniform performance of patient care processes. The hospital's failure to do so placed all patients of the Nuclear Medicine department at risk of incorrect, incomplete, or inconsistent care.

The hospital also failed to provide care that was consistent with the Diagnostic Imaging Quality Plan's Mission, as stated in the scope of care statement:
"Mission: To provide, safe, high quality, personalized imaging studies by specially trained technologist, nursing and ancillary staff to assist physicians in the accomplishment and plan of treatment for each patient."

Failure to Develop and Implement Correct and Complete Policies Regarding the Reporting of Allegations of Abuse/Neglect/Harassment

Based on review of hospital policy, it was determined that the hospital failed to establish and implement policies and procedures to guide staff/employees in the correct reporting of abuse/neglect/harassment. The hospital's failure to do so placed all patients who were victims of abuse/neglect/harassment at risk of unrecognized and unreported abuse/neglect/harassment.

Review of the hospital's policy, "Assessment: Reporting Abuse/Neglect of Children Policy" referred reporters to Child Protective Services (CPS) a division of the Washington State Department of Social and Health Services. The policy also stated "Reports may also be made to any law enforcement agency", but did not give clear guidance as to when that should occur.

The Department of Health (DOH) was not mentioned in any part of the policy. Any abuse/neglect/harassment, or suspected or alleged abuse/neglect/harassment that occurred by a person certified, registered or licensed by the DOH, must be reported to the DOH. In addition, any suspected or alleged abuse/neglect/harassment that occurred in an entity licensed by the DOH such as hospitals, hospices, and childbirth centers, etc. must be reported to the DOH.

The hospital's policy and procedure "Reporting Alleged Harassment, Abuse or Neglect of Patients While in Our Care" was reviewed and found to contain the same omissions relative to the DOH as the previously referenced policy.

The hospital's failure to develop and implement correct and complete policies on the reporting of suspected abuse/neglect/harassment left hospital workers without guidelines on such reporting, and potentially placed all victims of abuse/neglect/harassment at risk for unidentified and unreported abuse.



Failure to Provide Written Policies and Procedures, Reviewed and Approved by the Medical Staff, for Patient Care Services in Nuclear Medicine Imaging.

On August 7, the investigator made an onsite visit to the hospital and provided a written list of requested documentation. Included on the list was a request for "...all policies and procedures that describe qualifications, training, functions and responsibilities of nuclear medicine personnel, policies and procedures that describe how the hospital assures that supplies are maintained for safe and efficient performance, policies and procedures that describe how the hospital assures that nuclear medicine interpretations, consultations and procedures are assigned and dated..."

In addition to the written requests, a verbal request was made for the hospital to provide all policies and procedures that pertained to patient care processes/procedures.

Three documents were provided:
-"Sentinel lymph node localization" [this is the procedure performed on Patient #1. Of note: the document notes that lidocaine buffered with 2% lidocaine is "optional", but does not state whose option that is]
-"Breast Lymphoscintigraphy"
-"Melanoma Lymphoscintigraphy"

None of the documents were on hospital letterhead, none were entitled "Policy and Procedures, none had signatures or evidence of review and approval and none were dated. The Director of Nuclear Medicine services stated that the documents were currently being used as guidelines for the procedures described in the documents.

At the conclusion of the onsite visit, no signed policies and procedures specific to Nuclear Medicine services had been received by the investigator.

Reference Federal tags 0145
Reference State tags 0190, 0260, 0315 and 0620

Based on interview and review of medical records, it was determined that the hospital failed to assure that Patient #1 was free from neglect. The hospital's failure to do so resulted in pain, fear and discomfort for Patient #1, and placed all patients who underwent injections in the Nuclear Medicine department at risk for the same.

Findings include:

The complainant stated that on April 12, 2012, Patient #1, who had been diagnosed with breast cancer, underwent injections into the right breast as part of the pre-surgery workup. The complainant stated that the patient was told by the Nuclear Medicine technologist that the hospital had a shortage of lidocaine, and the pharmacy had told the Nuclear Medicine staff that the lidocaine in the hospital was "not approved" for the procedure the patient was having.

The complainant stated that the technologist injected Patient #1 directly into her breast, which resulted in severe pain. The complainant stated that the patient kicked the pillows off of the table and told the technologist that it hurt so badly she did not know if she could tolerate the remaining 3 injections. The technologist reportedly acknowledged that the injections were painful, but told the patient to "lie still" and said if the patient did not have all 4 injections, her surgery would have to be canceled.

The complainant stated that the patient reported that the technologist did not offer to go get the radiologist, or other imaging personnel, to try and find a way to help the patient.

Review of the patient's medical record for the procedure confirmed that no lidocaine, or other medication which might alleviate pain, was used for any of the 4 injections around the patient's nipple.

On August 6, 2012, the Nuclear Medicine technologist who treated the patient was interviewed. The technologist stated that the radiologist was not involved in any portion of the patient's care on the day of the injection. The technologist also recalled telling the patient that there was no lidocaine available due to a short supply of the drug.

The technologist stated that s/he remembered the patient and that the patient had been uncomfortable, but s/he did not think the discomfort was greater than any other patient experienced with that procedure. S/he did recall that the patient stated to her/him when the procedure was over that the patient would never go through that procedure again without lidocaine.

The technologist stated that s/he did not recall telling the patient to lie still, or telling her that her surgery would have to be canceled if she did not have all 4 injections, nor did s/he recall the patient kicking all of the pillows off of the table. S/he stated s/he did not recall the patient screaming, but s/he did recall that the patient had kicked her legs.

When asked why s/he had not asked for help, the technologist stated that s/he did not have specific guidelines on when and who to call for help, but for inpatients, s/he would call the patient's nurse. For outpatients (such as Patient #1), the technologist stated there were no specific guidelines.

The technologist stated that since the incident in question, the Nuclear Medicine staff had been informed that they could ask the Registered Nurse (RN) in Interventional Radiology for assistance.

The Regional Director for Diagnostic Imaging services was interviewed about the incident under investigation. The Director stated that s/he had met with the technologists to let them know what support was available to them, such as the RN in Interventional Radiology. The Director also stated that all policies and procedures for the Nuclear Medicine Services were under revision.

The Director stated that the pharmacy communicated directly with the technologists about the shortage of Lidocaine. Because the pharmacy did not communicate through leadership of the imaging department, imaging leadership was unaware of the situation with the shortage, did not know the medication was going to be restricted and did not subsequently have the opportunity to direct technologists on how to obtain the medication from other hospital departments.

The Director stated that the other 2 hospitals in the Franciscan network also did not routinely use lidocaine for the breast injection procedure that Patient #1 underwent.

Review of the hospital's policy and procedure, "Reporting Alleged Harassment, Abuse or Neglect of patients While In Our Care", the following definition of "neglect" was found:
"Willful failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness".

When asked if s/he believed that the experience of Patient #1 met the definition of abuse or neglect by causing the patient "mental anguish", the Director stated that she believed it did.

Based on interview, it was determined that the hospital failed to assure that the Medical Director for the Nuclear Medicine department was a physician who was qualified in nuclear medicine. The hospital's failure to do so placed all patients of the department at risk for incomplete, inaccurate or incorrect treatment and care due to lack of oversight by a Medical Director qualified in Nuclear Medicine.
Findings include:

On 8/7/2012, Risk Managers #1 and #2 were asked who the Medical Director for the Nuclear Medicine department was. They named a physician who they stated was the Medical Director for Radiology, not for Nuclear Medicine specifically. During the interview, the Risk Managers asked the Manager of Medical staffing if the Medical Director for Radiology was board-certified in Nuclear Medicine, and reported that the physician was not.

The Risk Managers were also asked to provide documentation of education, experience and specialized training for the Medical Director of Radiology, to confirm that he/she was qualified in nuclear medicine, appropriate to the scope and complexity of services offered.

The hospital did not provide such documentation, and on 8/21/2012, emailed documentation regarding current negotiations to obtain a qualified Medical Director for Nuclear Medicine.