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Based on document review and interview, the facility failed to ensure that its policy/procedure for adverse patient event reporting was followed and implemented corrective actions and provided feedback and learning throughout the facility for 1 of 10 medical records (MR) reviewed (patient #1).

Findings include:

1. The policy/procedure Reporting of Adverse and Unanticipated Patient Safety Events (approved 5-13) indicated the following: "Purpose: To provide a record of any unusual, unanticipated, or adverse events... with the purpose to assist leaders in their efforts to continually improve the care provided to our patients...[and]...Facts of the event are to be documented in the patient's medical record."

2. Review of the adverse event documentation on 7-8-16 indicated patient #1 reported feeling "itchy" and having some problems breathing after the CT scan was completed. The emergency response system was activated and two Medcheck physicians arrived shortly afterwards. The patient requested to sit up due to feeling nauseated and was assisted to a sitting position after lowering the CT table down and received an emesis basin. The primary physician returned to the Medcheck center to get a nurse to administer some medications while the radiologic tech and the second physician were present in the room with the patient. The technologist turned away from the patient sitting on the side of the CT table to remove some medications ordered for the patient from a drug box on the wall when the radiologic tech AH14 heard a crash of metal from the Mayo stand (a portable procedure table located next to the patient) and turned around to observe the patient lying face down on the floor. The patient was rolled over and was observed to have a chipped tooth and some bleeding around the mouth. The patient regained consciousness about the time the primary physician returned with a nurse practitioner and another nurse and 911 was called. The nurse practitioner and nurse administered the ordered medications and the EMS (emergency medical services) providers responding to the call transported the patient to a community ED (emergency department).

3. Review of the outpatient medical imaging documentation on 7-8-16 by the radiologic technologist, staff AH14 indicated the following: "No to IV questions. Unable to get delay scan due to allergic reaction to contrast - Pt was sent to ER."

4. Review of the adverse event documentation on 7-20-16 by the medical imaging manager, staff A7 indicated the following: "Reviewed and marked completed..." and no other documentation indicated an identified need to document the facts of the event in the MR or a need to counsel or re-educate the radiologic technologist regarding multiple errors in documentation timing identified during the complaint investigation.

5. Review of the adverse event documentation on 7-21-16 by the quality and risk coordinator, staff A10 indicated the following: "Standard of care met, no further action required. Complete..."

6. Administrative documentation on 8-1-16 by the medical imaging manager, staff A7 indicated the following: "Other than the Midas (adverse patient safety event) report, I do not see any other information documented by the technologist."

7. Review of email documentation received on 1-17-17 from the director of quality and risk, staff A3 confirmed the Radiant module for radiology staff documentation in the EMR is limited to comments of less than 150 characters and no other process for documenting facts of the event in the MR by radiology staff is in use at the present time.

Based on document review and interview, the facility failed to follow policy/procedure and ensure all Medical Record (MR) entries were accurately written and promptly completed for 1 of 10 MR reviewed (patient #1).

Findings include:

1. The policy/procedure Documentation in the Medical Record (approved 4-16) indicated the following: "The medical record shall contain sufficient information to... document accurately the course of treatment and results."

2. Review of the MR for patient #1 indicated a copy of an imaging order was printed 7-8-16 at 0850 hours for a routine abdominal and pelvis CT (computerized tomography) with oral and IV (intravenous) contrast. The Imaging Center medication administration record (MAR) indicated at 0700 hours that patient #1 consumed 50 ml (milliliters) of oral contrast and indicated at 0907 hours that 130 ml of IV contrast was administered by IV route at the start of the CT imaging study. The entries by radiologic technologist AH14 that indicated the CT exam began at 1003 hours and ended at 1058 hours and the times were not consistent with the CT image acquisition times that indicated the CT exam began at 0907 hours and ended at 0915 hours. The MAR entry on 7-8-16 at 1020 hours by radiologic tech AH14 indicated that 0.3 mg (milligrams) of Epinephrine 1mg/ml (mgs/milliliter) was administered by IM (intra-muscular) route and 50 mg Diphenhydramine (Benadryl) 50 mg/ml was administered by IV route to patient #1. The radiologic tech AH14's entry under Comments indicated: "...unable to get delay scan due to allergic reaction to contrast - Pt (patient) was sent to ER (emergency room; ED)." No MR documentation by radiologic technologist AH14 indicated the symptoms observed and/or reported by patient #1 as an allergic reaction, indicated the patient lost consciousness and experienced a fall, or indicated the patient sustained injuries associated with the fall event.

3. Review of the related ED MR on 7-8-16 indicated patient #1 arrived to the ED at 0947 hours and was examined by the ED physician, staff MD15. The ED record indicated the patient reported having diffuse itching before experiencing a syncopal episode (loss of consciousness with rapid onset and short duration) and falling face forward onto the floor with injuries including a lip laceration and chipped 2 front teeth.

4. The Medcheck East outpatient services documentation entered on 8-12-16 at 1614 hours by the physician, staff MD12 for care on 7-8-16 involving patient #1 indicated the physician was requested to respond to a patient experiencing an allergic reaction to IV contrast. The Medcheck progress note entry indicated the patient was complaining of itching, nausea and shortness of breath and facial flushing was observed by the physician. The progress note indicated physician MD12 gave orders to administer Epinephrine 0.3 mg IV and Diphenhydramine 50 mg IM before leaving the Imaging Center to obtain the assistance of additional staff to administer the medications and indicated the patient experienced a fall during the physician's absence and was lying on the floor and bleeding from the mouth and chin upon the return of physician MD12. The progress note indicated 911 was called and the patient remained on the floor until the arrival of EMS for transport to the ED. The Medcheck MAR (medication administration record) entries on 8-12-16 by physician MD12 indicated orders on 7-8-16 at 1018 hours to administer Epinephrine 0.3 mg by IM route and Diphenhydramine 50 mg by IV route. The routes of administration documented by physician MD12 in the Medication Record were inconsistent with the routes of administration documented in the physician's progress note and the times associated with both entries were inconsistent with the patient's arrival to the ED at 0947 hours on 7-8-16.

5. The Medcheck East outpatient services documentation created on 8-9-16 at 1118 hours by the Licensed Practical Nurse (LPN), staff AH15 for care on 7-8-16 involving patient #1 indicated the nurse administered Epinephrine 0.3 mg by IM route and no time of administration was identified. No Medcheck East documentation indicated a staff member responding to a patient emergency at the Imaging Center administered Diphenhydramine 50 mg by IV or IM route to patient #1.

6. On 1-12-17 at 1240 hours and 1300 hours, the medical imaging manager, staff A6 confirmed the imaging center MR for patient #1 lacked documentation of vital signs, description of the allergic reaction to IV contrast, or a syncopal episode resulting in a fall with injuries. The manager A6 confirmed the imaging center and Medcheck MR entries failed to accurately document the timing for the CT study, fall event, medications administered, arrival of EMS, and patient departure from the outpatient facility and confirmed the MR entries by physician MD12 and nurse AH15 were entered more than 30 days after the 7-8-16 episode of care.

7. Review of email documentation received on 1-17-17 from the director of quality and risk, staff A3 confirmed the Radiant module for radiology staff documentation in the EMR is limited to comments of less than 150 characters and confirmed no other process for documenting facts of the event in the MR by radiology staff is in use at the present time. The director of quality and risk, staff A3 confirmed the facility lacked a process for monitoring the Medcheck staff documentation associated with a medical response to an IV contrast reaction or other adverse patient occurrence at the outpatient Imaging Center.