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Based on staff interview, review of facility documents, and review of medical records, it was determined the facility failed to ensure comprehensive pain assessments and reassessments are completed in seven of ten medical records (Patient (P)1, P2, P3, P4, P5, P6, and P8), in accordance with facility policy.

Findings include:

Reference facility policy titled, "Pain Management", undated, states, "Guidelines: 1. A comprehensive pain assessment, includes but is not limited to, pain intensity, pain location, and quality, precipitating factors, alleviating factors, responses to treatment. This assessment is documented by the RN [registered nurse]: Med/Surg [medical-surgical] ...: The RN completes the pain assessment on admission, every shift while hospitalized, after interventions, day of discharge or transfer to another level of care, and PRN [as needed]. ...3. After pain management interventions, reassessments of pain will include the intensity level documented in the EMAR [electronic medication administration record]. The pain level will be reassessed within one hour in the EMAR according to the onset of the prescribed medication. 4. A task will generate in the EMAR for pain reassessment as follows: Sublingual- 5 minutes; IV [intravenous] -15 minutes; SQ[subcutaneous] /IM [intramuscular] -30 minutes; PO [by mouth]- one hour ..."

On 4/11/24 at 11:50 AM, medical record review was conducted with S1, Director of Risk Prevention, and S11, Clinical Informatics.

P1 was admitted on 1/1/24 at 11:59 PM, with a reason for visit of Cellulitis. P1 had an order for Hydromorphone 0.5mg IV (Intravenous) every 4 hours, PRN (as needed), Severe Pain (Pain Score 7-10). Medical Record (MR)1 lacked a comprehensive pain assessment prior to administration of Hydromorphone 0.5mg IV on: 1/2/24 at 8:56 PM, 1/3/24 at 2:00 AM, 1/3/24 at 6:09 AM, and 1/3/24 at 10:33 AM.

P2 was admitted on 12/25/23 at 8:16 PM, with a reason for visit of Acute Asthma. P2 had an order for Tramadol 50mg, PO, every 6 hours, PRN, Moderate Pain (Pain Score 4-6). MR2 lacked a comprehensive pain assessment prior to administration of Tramadol 50mg PO on: 1/6/24 at 2:08 PM, and 1/7/24 at 9:30 AM. P2 had an order for Tylenol 650mg, PO, every 6 hours, PRN, Mild Pain (Pain Score 1-3). MR2 lacked a comprehensive pain assessment prior to administration of Tylenol 650mg PO on: 1/1/24 at 6:34 PM, 1/2/24 at 12:50 AM, 1/3/24 at 2:07 PM and 1/3/24 at 3:33 PM.

P4 was admitted on 12/4/23 at 8:36 PM, with a reason for visit of Pneumonia. P4 had an order for Oxycodone 10mg, PO, every 4 hours, PRN, Severe Pain (Pain Scale 7-10). MR4 lacked a comprehensive pain assessment prior to the administration of Oxycodone 10mg PO on: 12/7/23 at 2:35 PM and 12/7/23 at 6:20 PM. MR4 lacked a pain reassessment following the administration of Oxycodone 10mg PO on: 12/7/23 at 2:35 PM and 12/7/23 at 6:20 PM.

On 4/11/24 at 1:11 PM, S1 stated, "...A complete pain assessment should be completed when administering pain medications." S1 confirmed a pain reassessment should be documented with a pain intensity level following the administration of a pain medication. S1 and S11 confirmed the findings above on 4/11/24 as they were identified.

On 4/12/24 at 11:22 AM, medical record review was conducted with S1 and S13, Clinical educator.

P3 was admitted on 1/21/24 at 2:19 PM, with a reason for visit of Abdominal Pain. MR3 lacked documentation of a comprehensive pain assessment upon admission. P3 had an order for Oxycodone 15mg, PO, every 4 hours, PRN, Severe Pain (Pain Scale 7-10). MR3 lacked a comprehensive pain assessment prior to the administration of Oxycodone 15mg PO on: 1/30/24 at 7:05 AM, and 1/30/24 at 12:41 PM.

P5 was admitted on 12/11/23 at 10:42 PM, with a reason for visit of Neck Fracture. MR5 lacked documentation of a comprehensive pain assessment upon admission. P5 had an order for Morphine 2mg IV, every 4 hours, PRN, Moderate Pain (Pain Scale 4-6). MR5 lacked a comprehensive pain assessment prior to the administration of Morphine 2mg IV on: 12/13/23 at 8:28 AM. MR5 lacked a pain reassessment following the administration of Morphine 2mg IV on: 12/13/23 at 8:28 AM.

P6 was admitted on 1/11/24 at 6:21 PM, with a reason for visit of Partial Intestinal Obstruction. P6 had an order for Hydromorphone 0.5mg IV, every 2 hours, PRN, Mild Pain (Pain Scale 1-3). MR6 lacked a comprehensive pain assessment prior to the administration of Hydromorphone 0.5mg IV on: 1/15/24 at 12:10 PM.

P8 was admitted on 12/21/23 at 7:19 AM, with a reason for visit of unilateral primary osteoarthritis of left knee. P8 had an order for Acetaminophen-Oxycodone 325mg-5mg 2 tablets, PO, every 4 hours, PRN, Severe Pain (Pain Scale 7-10). MR8 lacked a comprehensive pain assessment prior to the administration of Acetaminophen-Oxycodone 325mg-5mg PO on: 12/22/23 at 5:17 AM and 12/22/23 at 9:23 AM. MR8 lacked a pain reassessment following the administration of Acetaminophen-Oxycodone 325mg-5mg PO on: 12/22/23 at 5:17 AM.

On 4/12/24 the above findings were confirmed with S1 and S13 as they were identified.

Based on medical record review, facility document review, and staff interview, it was determined the facility failed to ensure that 1. policies and procedures that address the accountability of Controlled Dangerous Substances (CDS) are developed and implemented; and 2. prescription medication brought to the facility from the patient's home is returned to the patient upon discharge, in one of two medical records (MR), MR7, reviewed, in accordance with facility policy.

Findings include:

During the entrance conference on 4/11/24 at 10:00 AM with Staff #1 (S1), Director of Risk Prevention, S2, Chief Nursing Officer, and S3, Administrative Director of Quality and Regulatory, it was confirmed the facility identified an incidence of potential CDS diversion by S14, an agency Registered Nurse (RN). S14 was employed at the facility from 9/11/23 until 3/25/24. The facility's diversion investigation was reviewed, and indicated the facility's review of CDS usage was retrospective starting from 1/1/2024. On 4/11/24 at 10:20 AM, S5, the Informatics Pharmacist, stated the investigation did not include S14's CDS utilization from 9//11/23 through 12/31/23 due to a change in the facility's CDS monitoring process.

During an interview on 4/11/24 at 10:25 AM, S5, the Informatics Pharmacist, stated the facility currently uses a drug diversion monitoring software called "Blue Sight" to monitor staff administration and waste of CDS. S5 stated this program was fully implemented in March of 2024. This system sends CDS utilization data reports to the nurse managers for review, and has an embedded method to electronically track if the potential CDS discrepancy has been addressed. This software identified the CDS discrepancy that triggered the facility investigation into S14's CDS utilization on 3/25/24.

On 4/11/24 at 10:30 AM, S5 stated that prior to the use of "Blue Sight," CDS utilization and accountability was reviewed by manually reviewing CDS utilization reports and compiling the data on an Excel sheet. These data sheets were then shared with nurse managers for review. This system did not have a method in place to monitor if the nurse managers reviewed the CDS discrepancy data and completed the necessary follow up.

On 4/11/24 at 1:30 PM, the facility documentation that CDS utilization review was completed from 11/2023 through 12/2023, prior to the use of the "Blue Sight" software, was requested. The facility failed to provide documentation that CDS monitoring was completed prior to the institution of "Blue Sight." It could not be determined if the facility had a process in place to ensure the accountability of CDS prior to 1/1/ 2024.

On 4/11/24 the facility policy and procedure, that addresses the use of "Blue Sight" for monitoring of CDS accountability, was requested. On 4/11/24 at 10:45 AM, S5 stated he/she was not aware of a policy that addressed these processes. On 4/11/24, the facility failed to provide a policy and procedure that addressed the use of "Blue Sight" to ensure the accountability of CDS upon request. However, on 4/12/24 at 10:45 AM, the facility provided a document titled "Drug Diversion Prevention and Detection Policy" that was undated and stated "draft." The facility provided a new draft policy that addressed drug diversion processes in response to the surveyors' request on 4/11/24.

During an interview on 4/11/24 at 1:45 PM, S5 stated that patients are not profiled by the pharmacy department in the procedural areas of the facility, such as the operating rooms, the procedure rooms, and the cardiovascular institute (CVI) which includes the cardiac catheterization procedure room and the interventional radiology procedure room. S5 provided documentation that CDS accountability was monitored for anesthesia providers in the operating rooms and procedure rooms, however S5 stated the facility did not have a process in place to monitor CDS accountability in the CVI, as that area used an electronic medical record called IVIEW, that did not interface with Blue Sight, the drug diversion software. S5 confirmed the facility did not monitor CDS accountability in the CVI units. Medical record review conducted on 4/12/14 identified the following discrepancy:

On 4/12/24 at 1:47 PM, one of 10 Medical Records (MR), MR18, reviewed with S10, the Assistant Director of Pharmacy, and S15, a Registered Nurse (RN), revealed a discrepancy when compared with Omnicell medication CDS waste reports. Patient (P)18 was treated in the Cardiac Catheterization Unit on 3/14/24. MR 18 was documented in the electronic medical record called "IVIEW." The medication administration documentation dated 3/14/24 was compared with the report obtained by the facility's drug diversion software, BlueSight, and the Omnicell Waste Transaction Report. The Bluesight report revealed one 2 ml vial of Midazolam 1 mg (milligrams)/ml (milliliter) (a CDS) was removed from the Omnicell on 3/14/24 at 10:14 AM. MR18 lacks documentation that the Midazolam was administered to P18 on 3/14/24. The BlueSight Report and the Omnicell Transaction Report lack documentation that the Midazolam, removed for P18, was discarded as waste. The facility could not ensure the accountability of the Midazolam removed for P18. This finding was confirmed with S10 and S15 on 4/12/24 at 1:50 PM.

On 4/12/24 at 10:45 AM, the facility provided a document titled "CVI/Cardiac Cath [Catheterization] Controlled Med [Medication] Verification Process," undated. S12, the Director of Pharmacy, confirmed this document was a draft created on 4/12/24 at 11am, in response to the surveyors' requests made on 4/11/24. This document states, "...Nurse managers will do a random spot check (5 cases a day 2 days a week) that meds [medications] are correctly documented as given..." This monitoring process was not in place prior to 4/11/24.


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Policy titled "Medications Patient Brought From Home", undated, states, "Definitions: Patient's own medication- A prescription medication that a patient brings in from home during an inpatient or outpatient visit. ...19. At discharge nursing will return the patient's own supply of medication to the patient. ...".

On 4/12/24 at 11:22 AM, medical record review was conducted with S1, Director of Risk Prevention, and S13, Clinical Educator. MR7 contained a "Medication Order" dated 1/18/24 at 1:37 PM, for "Patient Own (Lomotil (Diphenox/atrop) 2.5/0.025 mg (id'd) POM [Patient Own Medication] ... Order comment: ** this is a narcotic ...stored in Omnicell as patient's own med ** patient initial count in RX vial = 30 tablets ...". S10 (Assistant Director of Pharmacy) provided P7's "Patient Profile" that stated, " ...Med Location ...For Patient Own Use In Hospital ...Medication Description Lomotil 2.5mg #30 tabs **sent to the floor for patient use.**" P7's MAR lacked documented administrations of this medication. MR7 lacked nursing documentation the medication was returned to the patient upon discharge. It could not be determined what happened to the medication P7 brought from home. The facility failed to ensure the accountability of a patient's own controlled medication from home. On 4/12/24 at 11:30AM. These findings were confirmed with S1.