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1705 S TARBORO ST

WILSON, NC 27893

SAFETY POLICY AND PROCEDURES

Tag No.: A0535

Based on facility policy review, medical record review, incident report review, personnel file review, and staff interview, the radiology staff failed to maintain complete documentation of contrast consent in 3 of 4 sampled patients receiving CT (computerized tomography) scans (Patient #4, #5, #10); and failed to maintain documentation of CT technician competency in 1 of 2 radiology staff personnel files reviewed (CT Tech #2).

The findings included:

A. Review of the facility policy, Pre/Post Procedure CAT (computerized axial tomography) scan and MRI (magnetic resonance imaging), effective 02/2021, revealed, "... Pre Procedure... 5. Obtain signed consent for IV (intravenous) contrast if ordered for procedure from patient... Post Procedure... 2. make all proper documentation in accordance with the radiology IV contrast policy..."

Review of the facility policy, Administration of IV Contrast Material in Radiology, effective 12/2019, revealed, "...All IV contrast media are considered and handled as a medication... Once the patient has been cleared for contrast media, perform the venipuncture and administer the contrast. 1. Document on the patient's contrast form: a. What was administered, b. Amount administered c. Time it was administered d. Site where it was administered e. Name of technologist administering contrast..."

1. Closed medical record review of Patient #5 revealed a 69-year-old female who presented to the ED on 06/27/2022 at 1124 with a chief complaint of fall. Review of the ED Summary Report - Rapid Initial Screen dated 06/27/2022 at 1156 revealed, "... Patient presents to ER via EMS from home with a complaint of frequent falls. Patient reports a fall today while walking down her driveway to take the trashcan to the road. Patient is complaining of bilateral hip pain, buttock pain, and has noted brown and green bruising to forehead..." Medical record review revealed orders for CT without contrast of the abdomen/pelvis, head, cervical/spine at 1138 by MD #5. Medical record review revealed Patient #5 had a CTA (CT Angiography - uses contrast) - Aorta Bilateral Iliofemoral runoff performed at 1218 by CT Tech #2. Review of the orders revealed an order for the CTA - Aorta Bilateral Iliofemoral runoff was placed at 1345. Medical record review revealed Patient #5 had a CT without contrast of the head and cervical/spine performed at 1414 and a CT without contrast of the abdomen/pelvis performed at 1420 by Radiology. Medical record review revealed Patient #5 was subsequently admitted to the facility with a diagnosis of "Elevated troponin (protein found in the heart muscle), Multiple falls, COPD (chronic obstructive pulmonary disease), Emphysema (air sacs in the lungs are damaged and enlarged), Celiac disease (digestive immune disorder that damages the small intestine), Rheumatoid arthritis (autoimmune disease that impacts the joints)..." at 2322. Review revealed Patient #5 was discharged on 07/02/2022 to a Skilled Nursing Facility. Medical record review failed to reveal the Consent for Contrast Material.

Review on 08/24/2022 of incident reports revealed one entry entered on 06/27/2022 related to Patient #5. Review revealed involved staff were CT Tech #1 and CT Tech #2. Incident report review failed to reveal comments related to missing contrast consent forms.

Interview on 08/24/2022 at 1010 with the Radiology Director #3 revealed that there was a recent incident in radiology that involved the misidentification of a patient and their CT scan results. Interview revealed that their investigation did not include the analysis of the consent process or contrast form completion.

Follow-up interview on 08/25/2022 at 1015 with the Radiology Director #3 revealed that the Consent for Contrast Material should be completed in its entirety for any patient that was receiving contrast. Interview revealed Patient #5's consent was unable to be located.

Interview on 08/25/2022 at 2130 with CT Tech #2 revealed that she recalled the incident from 06/27/2022. Interview revealed CT Tech #2 was on orientation on 06/27/2022 and her preceptor was present during the scan. Interview revealed that CT Tech #2 was not in the CT scan room when the transporter arrived. Interview revealed CT Tech #2 did not observe the identification of Patient #5 or the consent for contrast. Interview revealed CT Tech #2 was unsure of what happened to the contrast consent for Patient #5's CTA. Interview revealed CT Tech #2 had received coaching on the correct workflow to follow, including proper verification of patient information, consent for contrast, and waiting to select patients in the computer. Interview revealed CT Tech #2 had learned from this experience and worked to ensure patient safety from that day forward, especially when obtaining patient consent and confirming patient identification.

Interview on 08/25/2022 at 1631 with the Director of Quality (DQ) #7 revealed that all incident reports were reviewed by leadership. Interview revealed the incident related to Patient #5 was reviewed and the facility felt the resolution by the Radiology leadership was adequate. Interview revealed no root cause analysis or learning from defect was performed to identify the missing consent forms.

2. Closed medical record review of Patient #4 revealed a 41-year-old female who presented to the emergency department (ED) on 06/27/2022 at 0640 with a chief complaint of lower extremity injury/pain. Review of the ED Summary Report - Rapid Initial Screen dated 06/27/2022 at 0704 revealed, "... Pt (patient) reports to ED BIB (brought in by) EMS (emergency medical services)... with c/o (complaints of) having right thigh hematoma (collection of blood outside of the blood vessels). Pts hematoma expanding substantially since arriving to hospital. pulses intact, cap (capillary) refill >2 seconds (greater than 2 seconds). Pt had a central line placed and removed last week. Pt kidney transplant pt..." Review of the Emergency Provider Record dated 06/27/2022 at 1542 revealed, "... History of Present Illness: ... Awoke this morning with a hematoma to her right groin that has rapidly expanded over last 30-45 minutes. Patient is on Coumadin (blood thinning medication) due to history of PE (pulmonary embolism - blood clot in the lungs) back in the spring... Patient received dialysis 4 days a week... Past Medical History: ESRD (End Stage Renal Disease), HTN (hypertension - high blood pressure), PE, Pneumonia, Renal Disease, Seizures... Kidney transplant x 2 (2005, 2020)... PHYSICAL EXAM... Right groin: Patient has a large hematoma measuring roughly 15 x 20 cm (centimeters) to the right groin... ADDITIONAL COMMENTS: ... 08:25 am: ... Ultrasound results were reviewed. Case was again discussed with the surgeon. Agrees that a CTa needs to be ordered..." Medical record review revealed an order for a CTA - Aorta Bilateral Iliofemoral runoff ordered at 0953. Review of Physician Progress Note dated 06/27/2022 at 1045 by MD #4 revealed, "... recommended proceeding with a CTA with the plan to dialyze the contrast out. The ultrasound was not very helpful regarding bleeding process in the groin. I am not sure if this represents a pseudoaneurysm (when a blood vessel wall is injured and the leaking blood collects in the surrounding tissue) or if she just has a large hematoma. Certainly no procedure should be entertained until her coagulation (blood clotting) is corrected... Continue very close monitoring of the situation. Patient will likely have a poor prognosis (chance of recovery) given her need for anticoagulation (medicines that help prevent blood clots) and this delayed bleed from the right groin..." Medical record review revealed a second order for a CTA - Aorta Bilateral Iliofemoral runoff ordered at 1336 (3 hours, 43 minutes after the first CTA was ordered). Review of Physician Progress Note dated 06/27/2022 at 1426 by MD #4 revealed, "I reviewed the CTa that has now been done on the correct patient and it does show active extravasation in the right groin what appears to be from a small branch off the femoral artery just below the inguinal ligament... I have made arrangements for the operating room to be ready to receive this patient as soon as we have confirmation that her Coumadin has been reversed." Medical record review revealed Patient #4 received 1 unit of PRBC (packed red blood cells) before being transported to the OR at 1700. Patient #4 was subsequently admitted to the facility at 1737 and remained until her discharge on 07/04/2022 at 1712 to a Nursing Home. Review of the Consent for Contrast Material dated 06/27/2022 failed to reveal the site where the contrast was administered and the name of technologist administering contrast.

Interview on 08/24/2022 at 1010 with the Radiology Director #3 revealed that there was a recent incident in radiology that involved the misidentification of a patient and their CT scan results. Interview revealed that their investigation did not include the analysis of the consent process or contrast form completion .

Follow-up interview on 08/25/2022 at 1015 with the Radiology Director #3 revealed that the Consent for Contrast Material should be completed in its entirety for any patient that is receiving contrast.

Interview on 08/25/2022 at 1631 with the Director of Quality (DQ) #7 revealed that all incident reports were reviewed by leadership. Interview confirmed no incident report was entered on Patient #4 despite the delays in her care. Interview revealed the incident related to Patient #5 was reviewed and the facility felt the resolution by the Radiology leadership was adequate, therefore no root cause analysis or learning from defect was performed on either patient.

3. Closed medical record review of Patient #10 revealed a 53-year-old female who presented to the ED on 08/10/2022 at 1905 via EMS with chief complaints of Respiratory Distress. Review of the medical record revealed an order for CT PE Aorta with contrast dated 08/10/2022 at 1949. Review revealed Patient #10 was subsequently admitted to the Intensive Care Unit with a diagnosis of Acute CHF (congestive heart failure). Patient #10 was discharged home with home health services on 08/17/2022. Review of the Consent for Contrast Material dated 06/27/2022 failed to reveal the name of technologist administering contrast.

Interview on 08/25/2022 at 1015 with the Radiology Director #3 revealed that the Consent for Contrast Material should be completed in its entirety for any patient that is receiving contrast.

B. Review of the facility policy, Administration of IV Contrast Material in Radiology, effective 12/2019, revealed, "... 'Competency to Administer Contrast Media' forms will be maintained on individuals administering contrast to document training and proficiency..."

Review on 08/25/2022 of CT Tech #2 personnel file failed to reveal an orientation pathway confirming competency for the CT Tech role.

Interview on 08/25/2022 at 1617 with the Radiology Director #3 revealed that CT Tech #2 was off of orientation as of 8/5/2022 and was competent to function in her role. Interview revealed that orientation pathway was unavailable for review and currently unable to be located.

NC00191963