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101 CITY DRIVE SOUTH

ORANGE, CA 92868

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on interview and record review, the hospital failed to ensure one of nine sampled patients (Patient 1) received care in the safe setting as evidenced by:

1. Patient 1's suspected ADR was not reported to the incident report system.

2. Patient 1's pain was not consistently managed as per the hospital's P&P.

These failures had the potential to result in the unsafe care and poor clinical outcomes to the patient.

Findings:

On 10/7/24, Patient 1's medical record was reviewed with Assistant Nurse Manager 2 in the presence of the Assistant Director, Regulatory Affairs and Assistant Manager, Regulatory Affairs.

Patient 1's medical record showed Patient 1 was admitted to the hospital on 9/10/24.

1. Review of the hospital's P&P titled Adverse Drug Reaction dated April 2024 showed to complete the Incident Report for each suspected ADR detected during the course of practice.

Review of the Progress Note dated 9/12/24 at 2032 hours, showed to vaccinate Patient 1 for encapsulated bacteria prior to starting the treatment.

Review of the physician's order dated 9/13/24 at 1559 hours, showed to administer haemophilus B (a vaccine can help to protect against heamophilus influenzae type b infection) and meningococcal A & B (a vaccine can help to protect against meningococcal disease which could lead to meningitis or other serious infection)

Review of the MAR showed the following vaccinations and medications were administered to the patient by RN 2:

* The vaccination for meningococcal A was administered on 9/13/24 at 2000 hours.
* The vaccination for meningococcal B was administered on 9/13/24 at 2003 hours.
* The vaccination for haemophilus influenzae type b was administered on 9/13/24 at 2028 hours.
* Benadryl (an antihistamine) 25 mg IV was administered on 9/13/24 at 2107 hours.
* Benadryl 25 mg PO was administered on 9/14/24 at 0314 hours.

Review of the Provider Notification showed the following:

* On 9/13/24 at 2107 hours, Patient 1 complained of blurred vision, flashes on right eyes, and vomiting episodes. The Provider Response was that the MD came to check the patient to order IV Benadryl.

* On 9/14/24 at 0252 hours, Patient 1 just woke up with more rashes, complaints of pain in throat, and itching everywhere. The Provider Response was that the MD came to check patient and ordered Benadryl PO.

* On 9/14/24 at 0642 hours, Patient 1 had rashes up to her neck now.

On 10/7/24 at 1225 hours, Assistant Nurse Manager 2 was interviewed. When asked, Assistant Nurse Manager 2 stated the nursing staff should inform the physician right away if there was any suspected ADR and report the event to the incident report system right away or at least within 24 hours.

On 10/8/24 at 0935 hours, RN 2 was interviewed. RN 2 stated she notified the physician Patient 1's symptoms after the vaccination and received Benadryl order. When asked, RN 2 stated she considered it as suspected ADR. When asked, RN 2 stated she did not file the event to the Incident Report system.

2. Review of the hospital's P&P titled Pain Adult & Pediatric dated December 2023 showed the following:

* A comprehensive pain assessment/reassessment is conducted as appropriate to the patient's condition; scope of care; treatment and services provided; and methods are appropriate to the patient's age and/or ability.

* Upon admission, assess patient's history of pain experience including understanding of pain management techniques, and cultural beliefs regarding pain, as indicated.

* Assess for location, intensity (pain scores), duration, character or quality (burning, cramping, etc.), and aggravating or alleviating factors.

* Reassessment should be completed in a timely manner, within approximately one hour, to determine if the intervention is working or if the patient is experiencing adverse effects.

* If using verbal scale (0-10: 0 is being no pain, 10 is being the worst pain) or FACES and patient is sleeping when pain assessment/reassessment is due, observe and document normal or abnormal sleeping.

- Normal sleeping is defined as lying quietly, normal position, no facial grimacing, no distress (derived from FLACC), and respiratory rate within normal range to assess for ADR.

* If patient meets normal sleeping criteria, no further assessment is needed and document patient as sleeping.

* If patient does not meet normal sleeping criteria as described above, wake the patient up and obtain pain score.

On 10/7/24 at 1225 hours, Patient 1's medical record was reviewed with Assistant Nurse Manager 2 and Assistant Director, Regulatory Affairs and Assistant Manager, Regulatory Affairs.

Review of the H&P examination dated 9/10/24 at 1820 hours, showed Patient 1 presented to the hospital with whole-body pain in upper and lower extremities, headache, and chest pain,

Review of the Pain Assessment showed the following:

* On 9/14/24 at 0652 hours, Patient 1 complained of pain but refused pain medication. However, further medical record review failed to show the patient was assessed for pain location, intensity (pain scores), duration, character or quality (burning, cramping, etc.), and aggravating or alleviating factors as per the hospital's P&P.

* On 9/14/24 at 0838 hours, Patient 1 complained of generalized pain and received pain medication.

* On 9/14/24 at 0938 hours, Patient 1 was sleeping, and respiratory assessment was done. However, further medical record review failed to show the documented respiratory assessment including respiratory rate.

* On 9/15/24 at 1732 hours, Patient 1 complained of pain level 6 out of 10. However, further medical record review failed to show the patient was assessed pain location, duration, character or quality (burning, cramping, etc.), and aggravating or alleviating factors as per the hospital's P&P.

On 10/9/24 at 0901 hours, the Assistant Director, Regulatory Affairs and Assistant Manager, Regulatory Affairs verified the above findings.