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Based on interview, observation, medical record review and policy review, the facility failed to ensure the safety of patients receiving radiological services (A- 0535). The cumulative effect of this systemic practice resulted in the facility's inability to ensure patient safety during radiological tests. The average daily census of the facility is 162.

Based on interview, medical record review, observation, job description and policy review, the facility failed to ensure the safety of one patient (Patient #10) with a documented previous reaction to contrast dye, failed to ensure a GFR (Glomerular filtration rate) was calculated for one patient (Patient #8) with a history of kidney disease and failed to ensure the MRI screening form was filled out correctly for drug allergies for one (Patient #11) of 11 medical records reviewed. This had the potential to affect all of the facility's patients receiving radiologic procedures. The facility's average daily census is 162 patients.

Findings include:

1. The medical record review revealed Patient #10 was admitted to the facility on 12/07/14 with a diagnosis of Transient Ischemia Attack (TIA). The medical record contained an allergy summary form that listed Patient #10 as having an allergy to X-ray dye (contrast).

A history and physical dictated on 12/7/14 at 6:14 PM, revealed Patient #10 was allergic to multiple medications and instructed the reader to see the nurse's list.

A neurology consultation report dictated on 12/8/14 at 8:27 AM revealed Patient #10 had an allergy to X-ray Dye.

Staff D, a neurologist, ordered a MRI on 12/8/14 at 8:36 AM with and without contrast.

Review of a MRI Safety Screening Questionnaire revealed Patient #10 indicated he/she had a history of a MRI contrast allergy. The form stated pre-medication was required for patients with a history of a MRI contrast allergy.

The medical record lacked evidence Patient #10 received pre-medication prior to the MRI.

The MRI report revealed Patient #10 received 19 milliliters of Multihance (contrast) during the MRI. The report did not note how Patient #10 tolerated the procedure.

The record contained a Rapid Response Team Inpatient Record/Orders form that revealed a rapid response was called at 11:42 AM on 12/8/14 to the MRI location for Patient #10's complaint of chest pressure of 10 out of 10. The report stated the EKG revealed Patient #10 as having sinus rhythm. The form did not list the outcome of Patient #10 or indicate any medications were given. The form did not indicate a physician was present at the Rapid Response.

On 12/17/14 at 2:43 PM, Staff C, the physician who evaluated Patient #10 after the rapid response was interviewed via telephone. The physician reported Patient #10's neurological evaluation after the rapid response was normal. Patient #10 did not complain of chest pain and there was no hypoxemia. The physician reported there were no steroids indicated based on the assessment of Patient #10. The physician reported Patient #10 did not have an anaphylactic reaction to the MRI contrast.

On 12/16/14 at 1:34 PM, Staff E, the MRI Technical Chief, was interviewed. Staff E reported she/he normally reviews the MRI screening sheet prior to the MRI, but did not review Patient #10's form due to time restraints.

Staff E reported the nurse did not make him/her aware of the allergy at hand-off. Staff E reported Patient #10 never mentioned the allergy to him/her.

Staff E stated the only action taken since the incident was speaking to the nurse who handed off Patient #10. Staff E reported there has not been any re-education conducted with the MRI technicians yet and plans to discuss the incident at the MRI department meeting in two weeks. Staff E reported Patient #10 was fine after the injection and 23 minutes of scanning was completed. Staff E reported Patient #10 complained of feeling like a brick was sitting on his/her chest after the test and a rapid response was called.

The facility's Contrast Media Procurement, Storage, Control, Distribution, Administration and Monitoring policy (policy # 7340 - PP 201) was reviewed. The policy stated Radiology Services in coordination with the Pharmacy is responsible for the administration of all radiographic contrast media used within their respective areas. Technologists will review the patient's history as to any adverse reactions, previous history of allergy, lab results if required and/or previous resets performed. Patient exceptions, prior to administration, requiring direct supervision by the physician in charge include: if history indicates possibility of reaction, it will be reviewed with the physician in charge before the administration of the agent.

The job description for Staff E stated the principle duties and responsibilities include consistently following established hospital and departmental policies, procedures, and objectives as well as quality, safety and infection control standards.


2. Patient #11 was observed on 12/17/14 at 11:10 AM in a holding room following the completion of an MRI. Patient #11 had an allergy band on the left wrist. Staff E reported Patient #11 had an allergy to Penicillin. The MRI screening form was reviewed. The form revealed "NO" was marked indicating Patient #11 did not have a drug allergy. The findings were shared with Staff E on 12/17/14 at 11:14 AM and confirmed.


3. Review of Patient 8's MRI screening form on 12/3/14 at 9:05 AM revealed Patient #8 had a history of kidney disease. The form instructed the nurse to report the creatinine lab value, GFR (test to measure level of kidney function and determine stage of kidney disease) value and the date the values were acquired due to the history of kidney disease. The nurse did not document the creatinine lab value or the GFR value on the screening form.

Patient #8's lab values in the electronic medical system were reviewed. The creatinine value was listed, the GFR value was not. The MRI screening form for Patient #8 did not list the GFR value.

According to the facility's Attachment H2 for the Contrast Media Procurement, Storage, Control, Distribution, Administration and Monitoring policy (policy # 7340 - PP 201), a GFR must be calculated on all patients with a history of kidney disease.

On 12/17/14 at 9:00 AM, the findings were shared with Staff A and confirmed.