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8045 ROANE MEDICAL CENTER DRIVE

HARRIMAN, TN 37748

PATIENT SAFETY

Tag No.: A0286

Based on review of facilty policy, medical record review, and interviews, the facilty failed to ensure oversight related to a missed cervical spine fracture for 1 patient (#1) of 5 patients reviewed.

The findings included:

Review of the Quality, Patient Safety, and Performance Improvement Plan, dated 2022-2023 showed "...System Quality, Risk, Infection Prevention, and Regulatory Committees showed "...compromised of the local quality and safety leaders who have responsibility for quality, safety, risk...and accreditation at their respective organizations facilitated and staffed by system leaders. These committees offer support and internal expertise including but not limited to meeting the acute care accreditation standards for The Joint Commission and Center for Medicare and Medicaid [CMS], investigating quality of care concerns, tracking patient safety incident reports, responding to...other regulatory body complaints..."

Medical record review of ED Nursing Triage record dated 3/10/222 at 5:43 PM showed the patient stated she "...slipped in water and fell; c/o [complaints of] pain in left arm, and back of head; denies LOC [loss of consciousness] and blood thinners...states she cannot feel her fingers..." Her vital signs were as follows: blood pressure 183/97 [normal 120/80], Pulse 115 [normal 60-100], Respirations 17 [normal 16-20], and Oxygen Saturations 97% [normal 95-100] on room air. She was triaged with an Emergency Severity Index of a 3 indicating urgent but not emergent needs.

Medical record review of an ED Nurses Note dated 3/10/2022 at 6:29 PM showed "...patient states she cannot feel her fingers... she has bulging discs at C2 [cervical disk]..."

Medical record review of a Nurses Note dated 3/10/2022 at 6:44 PM showed "...pt. [patient] afraid she broke her neck. No point tenderness or step offs noted. States had pain with breathing. No issues when assessing breath sounds..." The patient was placed in a soft 'philly cervical collar' (immobilization device used for neck injuries).

Medical record review of the Electronic Physicians Orders dated 3/10/2022 at 6:49 PM showed an order for a Computed Tomography (CT) of the Cervical Spine without contrast was ordered by the ED Physician related to neck trauma, focal neuro deficits or paresthesia.

Medical record review of a radiology CT of the Spine without contrast report dated 3/10/2022 at 7:36 PM showed "...degenerative disc disease [damaged disk resulting in pain) at C5-6 is seen but otherwise vertebral bodies and intervertebral disc spaces are normal. Mild facet degenerative changes are present at several levels. No fractures are seen. No disc protrusion, spinal stenosis, neural foraminal encroachment [obstruction] or nerve root in the lung parenchyma [portion of lung tissue involved in gas exchange] and soft tissue structures in the neck included in the study are unremarkable. Impression: mild degenerative changes of the cervical spine. No acute process seen..."

Medical record review of an ED Physicians Record dated 3/10/2022 at 8:33 PM showed the patient presented after a fall in her kitchen around 5:00 AM [PM] this afternoon. She complained of neck pain and tingling in her fingertips of her left hand. She denied any bowel or urinary incontinence, headache, or LOC. The patient "...does have history of neck and back issues consisting of bulging disc for which she takes Gabapentin (medication used to treat nerve pain]..." Her physical examination showed she had 'paracervical tenderness of palpation' and decreasing sensation in her left fingertips with 'mild decreased strength in that hand'.

Medical record review of an ED Physicians Progress Note dated 3/10/2022 at 8:34 PM showed "...CT was remarkable. Clinically patient has a cervical strain with resultant radiculopathy [injury or damage to nerve roots in the area where they leave the spine]. Will treat patient with Medrol [steriod] dose pack and muscle relaxer pain relief. Patient follow-up with her primary care 1st of the week if symptoms are not markedly improved..." The patient's diagnosis included cervical radiculopathy due to trauma. She was discharged home in stable condition with prescriptions for a Medrol 4 milligram (mg) dose pack, Baclofen (muscle relaxer) 20 mg three times a day (TID), and Percocet (pain medication) 10/325 mg every 6 hours as needed for pain.

Medical record review of the Patient Summary dated 3/10/2022 at 8:47 PM showed the patient was given discharge instructions for Cervical Sprain and Cervical Radiculopathy.

Medical record review of a [Facility B] Primary Care Physician report dated 3/14/2022 at 7:00 AM showed the patient presented with 'hurt neck and numbness in fingers'. The patient's previous history showed "...she was seen in [Facility A] 5 days ago after a fall in her kitchen. CT scan showed DDD [degenerative disk disease] at C5-6 and some mild arthropathy. She is still experiencing severe pain and numbness down the left arm into the first three fingers. Pain is very positional and if she moved in certain directions, she yelps in pain. She is on an Medrol Dose Pack, Oxycodone [pain medication] and Baclofen...I recommended Physical Therapy [PT] but she declines. She wonders about an Magnetic Resonance Imaging [MRI] but I don't think that is necessary at this point-told her we would reevaluate in 4-6 weeks or sooner if worsening..."

Medical record review of a (Facility B) Primary Care Physician report dated 3/25/2022 at 12:15 PM showed the patient presented for a follow-up appointment related to cervical radiculopathy. The patient "...had a fall weeks ago and has had worsening pain in the left neck and shoulder and down into the arm with worsening radicular symptoms. Have not sent for injections yet but she is interested in that now. Has had only mild improvement with the Medrol Dose Pack. Has been using some pain medications in that period of time as well...cervical spasms, decreased flexion, and tenderness on palpation and normal extension...has radiculopathy left elbow and ulnar distribution. Shot of Decadron [steroid], and Toradol [nonsteroidal anti-inflammatory drug] given today with acute inflammation. We will set up for neurosurgery to evaluate for injection therapies there..."

Medical record review of an MRI of the Cervical Spine without contrast (performed at the Facility B Primary Care office) dated 5/16/2022 at 3:59 PM showed "...finding of suspicious fracture through the left inferior articular facet of C6 [cervical spine] with surrounding marrow and new mild anterolisthesis of C6 on C7. Cervical spine CT is recommended for further evaluation of this finding. Moderate degree for left foraminal stenosis is C6-C7 which appears new from previous exam..."

Medical record review of a (Facility B) Primary Care Physician report dated 5/20/2022 at 10:00 AM showed "...she [the patient] noted she had an MRI of her cervical spine after her fall which revealed a possible fracture in her C6-7 and moderate degenerative changes. She is struggling with worsening weakness in her left arm...has radiculopathy to left elbow and ulnar nerve distribution. Will proceed with CT as scheduled...persistent right radiculopathy and sciatica...unspecified displaced fracture of the sixth cervical vertebra, initial encounter for closed fracture..."

Medical record review of a CT of the cervical spine without contrast (performed at Facility B) dated 5/25/2022 at 11:46 AM showed "...subacute fracture anterior aspect superior articular facet [links two vertebrae] at C7 on the left with displacement into the left C 6-7 foramen and moderately severe left foraminal stenosis [narrowing of the disk space] as above. Trace anterolisthesis C 6 on C7...report faxed to [named neurosurgeon at Facility C]..."

Medical record review showed an Admission History and Physical (H&P) from Facility C dated 6/24/2022 was performed during a neurosurgery office visit. There was "...evidence of left sided facet fracture seen on the CT scan in March following her fall as well as the updated CT last week. She does have left foraminal stenosis noted at C6-7 and somewhat at C5-6...we would recommend surgical intervention. We have offered Anterior Cervical Discectomy and Fusion [ACDF] in C5-C7..."

Medical record review of an Operative Note from Facility C dated 7/13/2022 at 11:43 AM showed the patient had the following diagnoses: left C7 superior facet fracture with nonhealing line, left C7 radiculopathy, and cervical spondylosis (degeneration of the bones and disks in the neck). The following operation/procedures were performed: C5-6, C6-7 anterior discectomies (surgical removal of part of a disk in the spine) and osteophytectomies (surgical procedure) for decompression of thecal sac and nerve roots, Anterior cervical arthrodesis (surgical immobilization of a joint by fusion of the adjacent bones) C5-6, C6-7, placement of structural interbody cage C5-6, C6-7, placement of anterior cervical plate C5, C6, C7, and local bone graft harvest. The patient tolerated the procedure well, she was extubated, and moved to the Post Anesthesia Care Unit (PACU). She was admitted overnight for observation.

Medical record review of a Neurosurgery Progress Note from Facility C dated 7/14/2022 at 8:21 AM showed radiology diagnostic testing showed the hardware was in place and in good position. The patient was cleared for discharge and discharged home with follow-up appointments scheduled with neurosurgery.

During an interview on 8/23/2022 at 11:10 AM, the Risk Manager stated on 6/1/2022, the Risk Manager spoke with the patient on the telephone where the patient stated she was misdiagnosed during her admission to the ED on 3/10/2022. The patient had went to her Primary Care Provider multiple times and had an MRI which showed the cervical fracture where she was referred to a neurosurgery specialist. The patient stated she was unable to use her left arm, she was unable to work, and she may have to have surgery. She stated she wanted the x-ray relooked at by someone and they would see the fracture was missed. The Risk Manager stated the patient was told an investigation would be completed.

During a telephone interview on 8/23/2022 at 4:55 PM, Physician #1 stated the patient's case had been referred to the PEER review committee (evaluation of work by one or more similar competencies) related to the patient's complaint of a misdiagnosis.

During a telephone interview on 8/23/2022 at 6:30 PM, ED Physician #1 stated the patient presented to the ED after a fall at home and had radicular symptoms of numbness and tingling to her left hand and fingers. She had previous diagnosis of chronic degenerative disease. He stated "...given the presenting symptoms and her chronic degenerative history, I ordered a CT of the cervical spine related to the radicular symptoms and felt the CT would give the best results, and I wanted to make sure nothing was going on. She did complain of some neck pain with numbness and tingling to her hands and fingers. She was given pain medications, one dose of Prednisone while in the ED. Her CT results came back which showed the degenerative changes but did not show a fracture. A CT scan is diagnostic beneficial versus a plain film to get all the sections of the spine. I discussed the findings with her and based on the CT findings, I felt this was a sprain. I told her to follow-up with the primary care if the symptoms continued and gave her a Medrol dose pack, a muscle relaxer, and pain medications..." Physician #1 stated "...I was notified much later after the patient presented that she had stated she had a fracture based on an outpatient MRI..."

During an interview on 8/24/2022 at 9:45 AM, with the Quality Manager, the Quality Manager stated the patient's concerns had been forwarded to the Medical Director and PEER review. She stated "...once the PEER review process is implemented, the MEC takes control of it and that is protected information and we do not discuss the process to ensure the confidentiality of the PEER process. We did not complete any other quality improvements with the staff related to the complaint, as the case is in the PEER review..."

During a Video call on 8/24/2022 at 10:00 AM, the Vice President of Quality and Patient Safety, stated the patient's complaint and medical record had been placed under PEER review 6/6/2022 after the patient had notified the facility of the possible fracture. The facility was aware of the patient's allegation and a time-line had been completed. She stated "...on 5/16/2022 the patient had a MRI completed at a diagnostic center which showed a fracture at C6 and the patient was seen at the Primary Care Provider office on 5/20/2022. A CT of the cervical spine was completed on 5/26/2022 which showed a fracture at C6-7. On 7/13/2022 the patient had surgery at [Facility C]. The Radiology Medical Director did review the CT and this was taken to the PEER review..."

During a telephone interview on 8/24/2022 at 4:45 PM, Radiologist #1 stated he had read the CT on 3/10/2022. The patient had suffered a fall and had complaints of neck and shoulder pain. He confirmed the [medical director of radiology] presented the patient's complaint and further imaging to him later and he saw a subtle fracture at C6. He stated "...I did not see it at time, but retrospectively it was there, and I missed it. The medical record reflects no fracture and I seen it after the fact..."