Alamance Regional Medical Center

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 50403 Based on policy reviews, observations, medical record reviews, patient and staff interviews the hospital staff failed to provide care in a safe setting by failing to provide a “soft touch” call bell (adaptive call bell) for a patient to access the nurse call system for 1 of 5 patients observed (Patient #20). The findings included: Observation of the Cardiac Progressive Unit (CPU) on 05/07/2024 at 1220 upon entry to Patient (Pt) #20’s room revealed there was no call bell within reach of Pt #20. Pt #20 did not move his arms during observation but did move the left index finger freely. Pt #20 spoke very softly and was difficult to hear. Observation of the CPU on 05/08/2024 at 1145 revealed Pt #20 was in bed with a call bell on the abdomen but out of reach of the patient’s left hand. Observation revealed the call bell at bedside was not a “soft touch” call bell. Request for a policy, on 05/08/2024, revealed no policy existed on the use of soft touch (adaptive) call bells. Open medical record review for Pt #20 on 05/07/2024 revealed the 45-year-old patient presented to the ED (Emergency Department) on 04/23/2024 at 0134 with a chief complaint of “fatique and significant weight loss.” Review revealed Pt #20 was admitted to the Intensive Care Unit (ICU) at 0535 with sepsis (a potentially life threatening infection). Review of the History and Physical (H & P), dated 04/23/2024 at 0431 revealed “....Past Medical History (PMH) of severe obesity.... unintended weight loss, disuse (no use) of upper extremities and poor p.o. (oral) intake times few days.” Further H & P review revealed a plan for a PT/OT (physical therapy/occpational therapy) evaluation for mobility. Review of a Physical Therapy Evaluation on 04/26/2024 at 0845 revealed Physical Therapist #28 notified “nursing” of a recommendation for a “soft touch call bell” to be given to patient. Review of the Occupational Therapy (OT) evaluation on 04/26/2024 at 1324 revealed that Occupational Therapist #29 notified “nursing” that the “call bell on bed unable to be utilized by patient due to arm weakness.” Pt #20 arrived to the CPU from ICU on 04/29/2024 at 0449. Medical record review did not reveal any documentation of a “soft touch call bell” prior to 05/09/2024. Request to interview PT #28 on 05/09/2024 revealed the Physical Therapist was not available for interview. Interview with Pt #20 on 05/07/2024 at 1248 revealed that “everyone treats me good but frustrating cause my arms are heavy and can’t use call bell”. Pt #20 reported “if I need anything I would just yell for help”. Follow up interview with Pt #20 on 05/08/2024 at 1130 revealed that Pt #20 had a regular call bell and stated “I can’t reach my call light but I can see the call light” and “(I) just yell when I need something or wait for staff to come in to check on me.” Interview on 05/07/2024 at 1220 with RN #26, Nursing Manager, stated “we have paddle call bells (soft touch call bell) for patients who can’t use regular call lights and (patients) basically tap it with their head and this would be helpful. Not sure why (Patient #20) patient doesn’t have it. (I) think the (soft touch call bells) are somewhere on the unit.” Interview with RN #27, a staff nurse taking care of Pt #20, on 05/07/2024 at 1245 revealed the RN was “Unaware of adaptive call light.” RN #27 stated “this would be most helpful for patients like (Pt #20).” Telephone interview with RN #25, Nursing Director, on 05/08/2024 at 1540 revealed “(Pt #20) is in procedure right now... we will get this device to the patient upon arrival back to unit. Once (the) soft call bell is in place then staff will be trained on how to help pt with this device.” Interview with OT #29 on 05/09/2024 at 1415 revealed “...I did a bed level observation” and “put a note in the chart for special equipment needed, specifically soft touch call light and told nursing staff.” Interview revealed that once a recommendation is made to nursing staff then the nursing staff was to follow up and if there were issues then OT #29 “would take this up the line to my supervisor.... Haven’t been in to see patient since the initial evaluation.””

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 50111 Based on review of facility policies and procedures, medical record reviews, internal document reviews, and staff interviews, the facility staff failed to report a patient medication event for two missed medication doses for 1 of 2 sampled patients with medication events (Pt#13). Findings include: “The [Hospital System] Incident Reporting System provides an effective method for reporting, investigation, follow-up, analysis, and trending of incidents involving patients and visitors ... An incident is an event that is inconsistent with a [Hospital System] policy or procedure, or that is not part of the routine care of a patient ... Reporting: 1. Patient and visitor incidents should be reported on the web-based, online occurrence reporting system (named system) by the person(s) who witnesses or discovers the incident immediately ...” Review of facility policy “Formulary,” effective 02/21/2023, revealed, “... Formulary medication: A medication approved by the Pharmacy and Therapeutics Committee for inclusion on the hospital formulary. Formulary medications are generally available for routine use. ...” Closed medical record review on 05/07/2024 for Patient #13 (Pt#13) revealed a seventy-one year old male that presented to the Emergency Department on 08/23/2023 at 0955 and was admitted on 08/23/2023 at 1730 with acute osteomyelitis (infection of the bone) of the left great toe. On 08/23/2023 at 1402, MD#1 placed an order for Caplyta (a psychiatric medication used to treat multiple psychiatric disorders) 42 mg (milligrams) to be given daily. Review of the History and Physical, completed on 08/23/2023 at 1422, revealed Pt#13 had a history of schizophrenia (a psychiatric disorder that affects a person’s ability to think, feel, and behave normally) and a list of “Prior to Admission medications” that included Caplyta 42 mg daily. On 08/23/2023 at 1402, MD#1 placed an order for Caplyta 42 mg to be given daily. Review of the Medication Administration Record (MAR) revealed Caplyta was “not given” on 08/24/2023 at 1035 by RN#1 and “not given” on 08/25/2023 at 1106 by RN#2 with reasons documented as “medication not available.” Review of the Progress Note, completed by RN#2 on 08/25/2023 at 1242, revealed “Attempted to contact legal guardian regarding bipolar medication (Caplyta) listed in MAR not on formulary to see if medication could be brought to the hospital for daily administration...” Review revealed Seroquel (a psychiatric medication used to treat multiple psychiatric disorders) 25 mg by mouth was ordered on 08/25/2023 at 1643 by DO#5 and the first dose was given at 1734 by RN#2. Review revealed the order for Caplyta was discontinued on 08/26/2023 at 0650 by Pharmacist#4. Review of the Progress Note, completed by DO#5 on 08/26/2023 at 1715, revealed Pt#13 “... was started on Seroquel yesterday due to severe agitation and aggression attributed to being off his psych [psychiatric] medication (Caplyta) which is nonformulary...” Review revealed Pt#13 did not receive Caplyta during the patient’s hospital stay and the added Seroquel was not started until 2 days after the patient was admitted. Pt#13 was discharged on 08/27/2023 at 1233 with instructions to continue Caplyta 42 mg daily. Review of the (Hospital System C) Pharmacy Formulary, last updated 06/2023, revealed “Lumateperone... BRAND(s): Caplyta” was an approved addition to the pharmacy formulary on 04/2022. Request on 05/08/2024 at 1630 for an incident report related to Pt#13 revealed no incident report existed. Interview on 05/08/2024 at 0935 with DO#5 revealed DO#5 recalled Pt#13 after a “brief review” of the medical record. Interview revealed DO#5 did not recall why Caplyta was unavailable. Interview revealed Seroquel was most likely ordered as a substitution for Caplyta. Interview on 05/09/2024 at 1120 with the Pharmacy Director (Director#6) confirmed Caplyta was an approved addition to the pharmacy formulary in April 2022. Interview revealed Caplyta was not stocked at Hospital A in 2023 due to infrequent usage but was stocked at Hospital B and was available to Hospital A in August 2023. Interview on 05/10/2024 at 1445 with Director#7 verified an incident report had not been completed related to Pt#13 not receiving Caplyta. Interview revealed an incident report should have been completed by nursing staff or the pharmacist.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 32003 Based on policy review, medical record review, screenshot review from the automated dispensing machine, and staff interviews, the facility staff failed to administer Haldol as ordered by the physician for 1 of 1 patient (Patient #18). Findings included. Review on May 7, 2024 of the facility’s policy, “Medication Administration and Barcode Scanning” approved September 27, 2023 revealed, “PURPOSE: To provide quality patient care through safe administration of medications. ...POLICY: All patients’ medications will be administered and documented accurately, appropriately, and in a timely manner, based on physician orders ...” Closed medical record review on May 7, 2024 revealed on December 19, 2023 at 9:54 AM, Patient #18, a 93-year-old, was transported to the emergency department, via ambulance, with a complaint of shortness of breath with abnormal breath sounds. While in the emergency department, the patient received interdisciplinary care and at 1:21 PM, the medical determination was to keep the patient in the hospital for monitoring. At 9:43 PM, the patient was transported from the emergency department to [nursing unit] and the plan of care included medication administration. On December 21, 2023 at 5:25 PM, the patient had an order for Haldol, 2.0 milligrams, intravenous, every six hours as needed for agitation. The medication was dispensed at 9:42 PM from the automated dispensing machine and administered to the patient at 10:01 PM by RN #22. On December 22, 2023 at 2:44 AM, 2.0 milligrams of Haldol was dispensed again from the automated dispensing machine and administered to the patient at 2:52 AM by RN #22, (4-hours and 51-minutes from the last administration). On December 25, 2023 at 12:28 midnight, a nurse dispensed 2.0 milligrams of Haldol from the automated dispensing machine and administered to the patient at 12:32 midnight. The medication was dispensed again on December 25, 2023 at 6:23 AM from the automated dispensing machine and administered to the patient at 6:28 AM by RN # 23, (5-hours and 56-minutes from the last administration). At 10:26 AM, Hospitalist #42 rounded on the patient and the assessment revealed, an oxygen level above 90% via 4-5 liters of oxygen by nasal cannula, audible coarse breath sounds, asleep but awaken with sternal rub. The plan of care was discussed with the Nurse and the patient’s next of kin and included limiting sedatives. On December 26, 2023 at 12:06 noon revealed, the patient had a low oxygen level that ranged between 70s-80s and a heart rate between 40s-200s. A rapid response was called and collateral information obtained from a nurse revealed, the patient received “quite a lot of medication last night to help with agitation.” Interventions were performed by the rapid response team and the plan of care included notification of the physician for review of orders. At 1:50 PM, Hospitalist #43 examined the patient and determined the patient was “somnolent and difficult to arouse”, which was thought to be related to overmedication due to acute delirium in the evening with minimal intake by mouth. The hospitalist contacted the patient’s next-of-kin and the plan of care was updated. At 3:29 PM, the patient had an order for Haldol, 1.0 milligram, intravenous, every six hours as needed for agitation. At 3:23 PM, a nurse dispensed 1.0 milligram of Haldol from the automated dispensing machine and administered to the patient at 3:27 PM. At 4:45 PM, Speech-Language Pathologists (SLP) #44 rounded on the patient, but canceled the bedside swallowing evaluation, because the patient was not following commands, somnolent, and was not appropriate for assessment of oral intake. On December 27, 2023 at 9:03 PM, 1.0 milligrams of Haldol was dispensed from the automated dispensing machine and administered to the patient at 9:10 PM by RN #24, (5-hours and 43-minutes from the last administration). Review revealed Haldol was not administered as ordered during the patient’s hospitalization. Review on May 10, 2024 of a screenshot from the [nursing unit] automated dispensing machine revealed, on December 22, 2023 at 2:52 AM, RN #22 received a dispensing advisory that Haldol, 2.0 milligrams was too close from the last administration. On December 25, 2023 at 6:28 AM, RN #23 received a dispensing advisory that Haldol 2.0 milligrams was too close from the last administration and on December 27, 2023 at 9:10 PM, RN #24 received a dispensing advisory that Haldol, 1.0 milligram was too close from the last administration. Review revealed three nurses received Haldol dispensing advisories for Patient #18. Telephone interview on May 9, 2024 at 2:26 PM with the Medication Safety Officer revealed, automated dispensing machine did have “hard-stops” for certain medications but did not have “hard-stops” for medications ordered as needed, as this was a system-wide functionality. The safety officer continued with that the automated dispensing machines gave “best practice advisory” warnings. Furthermore, there were no proactive measures to prevent as needed medications from being dispensed too soon. The interview revealed there should have been communication related to frequency of Haldol administration or if another medication would have been better suited for the patient. Telephone interview on May 10, 2024 at 9:18 AM with RN #22 revealed, the nurse recalled the patient as being confused. The patient was in the patient care assignment for another nurse. Oftentime and due to a low oxygen level, 30-minutes to 1.5-hours was used to keep the patient calm, because the patient’s safety was the overall concern. Interview revealed, the nurse did not recall the “best practice advisory” for Haldol on the [nursing unit] automated dispensing machine. Interview request on May 8, 2024 with RN #23 revealed the nurse was unavailable for interview.”