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Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to: 1). implement and maintain an effective Quality Assessment and Performance Improvement (QAPI) program for drug diversion. (A0263); and 2). ensure the implementation of pharmaceutical policies and procedures that minimize the potential for medical errors and drug diversion (A0489).

Cross reference:
482.21 - Condition of Participation: Quality Assessment and Performance Improvement Program
482.25 - Condition of Participation: Pharmaceutical Services

Based on staff interview and review of facility documentation, it was determined that the facility failed to implement and maintain an effective Quality Assessment and Performance Improvement (QAPI) program for drug diversion (A0283).

Cross reference:
482.21(b)(ii): Quality Improvement Program Activities, Program Data

Based on staff interview and review of facility documents, it was determined that the facility failed to ensure action plans were developed and implemented when opportunities for improvement were identified.

Findings include:

Upon request, the facility's Drug Diversion Committee Meeting Minutes for the past 12 months were provided for review. The following issues were noted:

The October 20, 2022 meeting minutes stated, "Process - Waste Documentation Issue: Controlled Substances NOT Wasted - 8 Reports filed for August - Our Incident reporting system (EARS) is voluntary; this does not capture all unwasted controlled substances - [Name (Staff 5), the Drug Diversion Director] is meeting with AVPs [Associate Vice Presidents] to address concerns."

The January 19, 2023 meeting minutes stated, "Process - Waste Documentation Issue: Controlled NOT Wasted - 17 reports filed for November 2022 - [Staff (S) 5] is meeting with AVPs to address concerns."

The February 16, 2023 meeting minutes stated, "Process - Waste Documentation Issue: Controlled Substances NOT Wasted - No updates."

The April 20, 2023 meeting minutes stated, "Process - Waste Documentation Issue: Controlled NOT Wasted - December 2022: 8 events reported - January 2023: 12 events reported - February 2023: 11 events reported - March 2023: 8 events reported! There are many more CSs [Controlled Substances] not wasted that are not recorded in the EARS system ... Delays in waste: bedside procedures, emergent situations ... are all considered when assessing the why for a delayed waste."

The June 15, 2023 meeting minutes stated, "ALERT CONTROLLED SUBSTANCE WASTE - 11 Top Violations at [facility name] ... Delayed Waste ... No Waste ... Unresolved Discrepancy ... Process - Waste Documentation Issue: Controlled NOT Wasted - April 2023 -13 EARS Reports filed - Question: Is the reduction in numbers a decrease in reporting or events - Unknown: [S5] will research and share with the committee next month ... ."

The July 20, 2023 meeting minutes stated, "... EARS Reports Process - Waste Documentation Issue: CSs NOT wasted January - June 2023 EARS filed : 57 (missing June #s) EARS requested but not filed: 122 Total CSs NOT wasted: 179 (missing June EARS filed #s) ... ACTION/DECISION Educational Reference Document will be sent to leadership ... ."

On 9/28/23 at 12:56 PM, S5 stated that he/she follows the discrepancies of the controlled substances via an Omnicell report. S5 provided an outline to the Clinical Directors of patient care units of how to use the reports. S5 stated that the reports are reviewed everyday and if there is an unresolved discrepancy, an EARS report should be created and leadership is notified. S5 stated that the above issues were discussed with leadership, but he/she was not aware of any follow-up or an action plan in place to address the identified issues. S5 also confirmed he/she reports the drug diversion issues at the Quality and Patient Safety Committee meeting.

Upon request, the facility's Quality and Patient Safety Committee Meeting Minutes for the past 12 months were provided for review.

The January 24, 2023 meeting minutes stated, "... Pharmacy - Medication Safety ... Medication Safety Reports Override Data - 5 dept. [departments] over (unfavorably) to establish target - need f/u [follow-up] on causes and plan to reduce ..."

A document titled, "Patient Safety Committee Follow-Up Item(s)" dated 1/24/23, stated, "...Agenda Item... Pharmacy - Medication Safety; Responsible Parties [Names (S47), the Clinical Pharmacist and (S48), the physician]; Follow-Up Override Data - 5 dept over to establish target - need f/u on causes and plan to reduce; Status Meeting Scheduled for 2/14/23 w/ [with] [Names (S47, S48, S49, the Vice President of Quality and Safety, and S34, the Associate Chief Nursing Officer)] a/o [account of] 2/21/23 - [Name (S47)] not in attendance for QPS [Quality Patient Safety] meeting ... Will provide update at the next meeting ..."

A review of S5's Drug Diversion Director job description included, "... This position is responsible for all aspects of the drug diversion program: oversights and direction for daily operations and all aspects of drug diversion education, prevention, monitoring, investigation, and reporting at [Facility Name]. This position has responsibility to create organizational policies and procedures for the development of this key program ... ."

On 9/29/23 at 10:57 AM, S5 confirmed that he/she has no team to assist him/her with investigating drug diversion issues, and should he/she not be available due to sickness or other engagements, there is no alternative staff member that assumes his/her role. If there was a drug diversion issue, it would have to wait for him/her to get back. S5, stated that due to a change in their reporting of incidents, there has been an increase in drug diversion reporting within the facility and to the State of New Jersey. S5 indicated that the increase in reporting has impacted his/her ability to complete investigations and write reports timely.

On 9/29/23 at 11:02 AM, the above information was shared with S34. S34 was asked if there was additional follow-up and an action plan in place regarding the issues with the overrides and controlled substance waste. S34 stated that he/she was not aware that any action plan was in place. S34 stated that in regards to the drug diversion program, "We have work to do. We have broken and undeveloped processes."

Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure: 1). a Registered Nurse suspected of Drug Diversion, was prohibited from accessing locked areas including the medication room and the Omnicell Automated Drug Dispensing Cabinet, in accordance with facility policy (A0500); 2). the implementation of policies and procedures that address the wasting of Controlled Medications (A0500); and 3). drugs were kept in a secure area to prevent unmonitored access by unauthorized individuals (A0502). This failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patients.

On 9/29/23 at 1:53 PM, an IJ was identified for the facility's failure to ensure an RN suspected of Drug Diversion, was prohibited from accessing locked areas including the medication room and the Omnicell Automated Drug Dispensing Cabinet, in accordance with facility policy (A0500). On 9/29/23 at 2:09 PM, the facility Administrator was informed of the IJ findings, and a copy of the IJ template was provided. An immediate removal plan was requested at that time. On 10/2/23 at 7:12 AM, an acceptable removal plan was received, and the facility implemented the following: Policy and Procedure review, and staff re-education. On 10/2/23, during an onsite visit, the surveyors were able to verify implementation of the removal plan through review of facility documents, staff interviews, and review of staff education documentation. The IJ was removed on 10/2/23 at 10:53 AM, and Condition level noncompliance remains.

Cross reference:
482.25(b): Delivery of Services
482.25(b)(2)(i): All drugs and biologicals must be kept in a secure area, and locked when appropriate

Based on observation, staff interviews, medical record review, video surveillance review, and review of facility documents, it was determined that the facility failed to ensure: 1). a Registered Nurse (RN) suspected of Drug Diversion, was prohibited from accessing locked areas including the medication room and the OmniCell Automated Drug Dispensing Cabinet; and 2). the implementation of facility policies and procedures that address the wasting of Controlled Medications.

Findings Include:

1. On 9/27/23 at 11:15 AM, an interview was conducted with Staff (S) 4, the Deputy General Counsel, and S5, the Director of Drug Diversion and Prevention. S5 stated that a drug diversion involving S31, a Registered Nurse (RN), occurred on the K10-North unit which is a Medical Surgical Intermediate Floor. The facility uses "OmniCell" as the Automated Drug Medication Distribution Cabinet and "FairWarning" as the software that reviews the OmniCell Controlled and Dangerous Substance (CDS) to identify potential CDS discrepancies. S5 indicated that he/she was made aware of a patient complaint on 9/14/23 regarding S31. According to the facility investigation S27, the K10 unit Clinical Director, indicated that the Patient (P) 1 reported to S26, the K10 unit Associate Clinical Director, that the patient believes that he/she was administered the wrong medication by S31 on two separate occasions.

On 9/27/23 review of P1's medical record revealed that P1 presented to the Emergency Department (ED) on 8/22/23 at 12:02 AM with a chief complaint of Lower Left Extremity (LLE) pain and was diagnosed with Compartment Syndrome. P1 was admitted to the hospital on 8/22/23 at 4:53 AM

An email, dated 9/15/23 at 1:11 PM, sent by S27 to S5 contained the following information: P1 complained to S27 on 9/14/23 regarding S31. S27 conducted a follow up investigation for P1's complaint on 9/15/23. During an investigative interview by S27 with P1, P1 indicated that S31 had given him/her the wrong medication in place of the controlled substance for pain Oxycodone (pain medication) 30 mg (milligrams) IR (Immediate Release). P1 reported to S27, " ... (Sat 9/9) around shift change, I put the blue pill in my mouth and before I sipped I could taste it [the blue pill] almost dissolved in my mouth and I got no pain relief, meds overnight were fine and I didn't taste [the pill], the next morning it was the same nurse so now I was paying attention when [Name (S31)] brought my meds and I took a picture because of what happened the night before, I dumped the meds onto my table, looked at the blue pill and said this med is for irritable bowel and I don't have that, [S31's] response was that's funny it must of came out of bubble pack wrong and [S31] took the pill, after that everything was fine and I was paying attention, [S31] was spot on the rest of the day almost to let's keep [P1] happy."

On 9/14/23, S27 requested the OmniCell report for 9/10/23. The OmniCell report revealed that S31 pulled Oxycodone IR 30 mg at 7:08 AM for P1. The medication administration record (MAR) for P1 stated, "Not Given ...Reason Refused" documented by S31 at 8:13 AM. The OmniCell report indicated that the Oxycodone IR 30 mg was wasted on 9/10/23 at 8:15 AM with another nurse. The OmniCell report indicated that Dicyclomine 20 mg (antispasmodic) was removed at 7:57 AM for P2, and P2's MAR lacked evidence that it was given.

On 9/15/23, S27 requested the OmniCell report for 9/9/23. The OmniCell report revealed S31 removed Oxycodone IR 30 mg for P1 on 9/9/23 at 6:32 PM. The MAR for P1 indicated that Oxycodone 30 mg IR was given at 6:33 PM. Per the Omnicell report, Dicyclomine 20 mg was removed for P3 at 2:50 PM, who did not have an order for this medication on his/her MAR. P1's medical record revealed no relief of pain on 9/9/23 after receiving the medication administered by S31.

On 9/27/23, the "Transaction by User" report from the OmniCell Automated Dispensing Cabinet from "Date Range 9/9/2023 12:00:00.00 am- 9/10/2023 11:59:59.99 pm ... User Name: [S31] ..." and the MARs for P1, P2 and P3 were reviewed with S5 and revealed the following:

On 9/9/23, the OmniCell report for P1 revealed S31 removed an Oxycodone IR 30 mg tablet at 6:32 PM, and the MAR documented it as given at 6:33 PM.

On 9/9/23, the OmniCell report for P3 revealed S31 removed Dicyclomine 20 mg tablet at 2:50 PM. Review of the MAR for P3 revealed there was no order for Dicyclomine or that it was administered.

On 9/10/23, the OmniCell report for P1 revealed S31 removed an Oxycodone IR 30 mg tablet at 7:08 AM, and the MAR documented it as "Administration Not Given ...Refused."

On 9/10/23, the OmniCell report for P2 revealed S31 removed Dicyclomine 20 mg tablet at 7:57 AM, and the MAR revealed there was no administration of the medication on that day.

On 9/27/23 at 11:15 AM, S5 stated that he/she was notified of the complaint from P1 on 9/14/23 by S27 and suspected S31 of drug diversion. S5 stated that S31 "did not return until 9/21/23 for [his/her] next shift and was pulled in for an interview with Human Resources, the Clinical Director, Associate Clinical director, and a union representative." S5 also stated that "I was on a flight and as soon as I landed, I came to the hospital so we could do the interview." S5 indicated that S31's shift began at 7:00 AM on 9/21/23 on the K10-North unit and S31 was assigned patients until the meeting, which occurred around 2:00 PM. S5 indicated during the interview that S31 denied stealing any medication and consented to a drug screening. S31 had a backpack in a locker on the K10-North unit that was brought into the interview area and was searched. Upon request to S5 of the contents in S31's backpack the following list was provided: "Controlled Medications: Pregabalin 75 mg [quantity] (2); Lomotil 2.5 mg 0.025 [quantity] (5); Loperamide 2 mg [quantity] (1); empty oxycodone 5 mg [quantity] (2); Clonidine 1 mg [quantity] (1); Lorazepam 4 mg [quantity](1-empty); Hydromorphone 2 mg [quantity] (2-empty); Hydromorphone 2 mg [quantity] (2-trace amount); Hydromorphone 0.5 mg [quantity] (2-trace amount); Morphine 4 mg (1- trace amount). Non Controlled Medications: Protonix 40 mg [quantity] (6); Dicyclomine 20 mg [quantity] (9); Tylenol 325 mg [quantity] (22); Ibuprofen 600 mg [quantity] (3); Melatonin 3 mg [quantity] (15); Pepcid 20 mg [quantity] (3); Naproxen 500 mg [quantity] (1); Zofran 4 mg tabs [quantity] (19); Senna [quantity] (1); Tylenol liquid 160/5 mls [quantity] (7) (6 full and 1 empty); Refresh tears; Unidentified white liquid with syringe (Precedex); Oblong orange tablet [quantity] (18) 1 round orange tablets (all in on [sic] bag); Lidocaine patches [quantity] (2); Zofran 4 mg sealed vial [quantity] (1); Toradol 30 mg [quantity] (1-1/2 empty); Haldol 5 mg [quantity] (1-trace); Benadryl 50 mg [quantity] (2-trace). Open syringes- 6 with needles on; Open needles- 6 blue and 1 yellow; Open syringes-1.4 ml [milliliter] filled with clear substance, 3 cc [cubic centimeter] syringe with pink substance, 5 cc syringe with pink substance; 5 white caps; 2 pharmacy empty clear bags; 1 clear bag with patient name; White container of gummies (marijuana)." S31 was arrested by the onsite Sheriff's Department. S31 was suspended pending the completion of the investigation and Urine Drug Screening results as of 9/29/23.

On 9/27/23 at 2:06 PM, S27 indicated that the first day S31 worked after being suspected of diversion was on 9/21/23 and that "around 1:30 [PM] called [S31] into the office to let [S31] know we were having a meeting about a patient complaint." S27, confirmed that S31 "had assigned patients and access to the Omnicell" on 9/21/23 from the start of S31's shift at 7:00 AM until approximately 1:30 PM. The Nursing Assignment sheet for 9/21/23 confirmed S31 had been assigned four patients for that day.

The "Transaction by User" report from the OmniCell Automated Dispensing Cabinet "Date Range 9/21/2023 12:00:00.00 am- 9/21/2023 11:59:59.99 pm ... User Name: [S31] ..." indicated that S31 had "33 Transactions" for that time period, 10 of those transactions involved Controlled Medications at the following times: 7:43 AM, 8:24 AM, 8:37 AM, 10:03 AM, 10:06 AM, 10:07 AM, 11:38 AM, 12:47 PM, 12:53 PM, 12:59 PM.

On 9/28/23 at 12:15 PM, an interview was conducted with S5. S5 stated that he/she "will get notification from the FairWarning Analyst if an employee is trending for two months or more of pulling more narcotics than peers." S5 indicated that S27 was notified over the summer that S31 was trending higher than peers on the K10 unit but S31 went on leave. S5 was made aware when S31 returned from leave and began to watch if S31 began trending again, S5 wanted "enough information" to see if the behaviors were continuing, to provide to Human Resources (HR). After P1 reported the complaint, S5 gave all information to HR and was approved to pull S31 in for an interview. S5 stated, "HR has to give the approval to interview and/or search an employee." S5 stated the reason S31 was allowed access to the unit and OmniCell once being suspected of diversion was "I am the only one that can interview, so as soon as I got off the plane I came here for the interview." S5 indicated being "unsure" who would act in his/her role if he/she is not available to interview staff suspected of drug diversion.

On 9/28/23 at 1:11 PM, an interview was conducted with S43, Director of HR. S43 stated, "Clinical Directors can suspend employee access" if an employee's access to the units or OmniCell needs to be suspended.

The facility policy titled, "3.411- Prevention and Suspected Drug Diversion, Theft, Loss, and Reporting Policy," Reviewed 12/19/22, stated, "1. PURPOSE: A. The purpose of this policy is the following: ... 2. To establish the process for reporting, and investigation of suspected or confirmed events of loss, theft, or diversion of medications, including controlled substances .... III. DEFINITIONS: ...F. Diversion: the transfer of a prescription drug from a lawful to an unlawful channel of distribution or use. Any act of deviation that removes a prescription drug from its intended path; from the manufacturer to the patient. IV: POLICY: A. It is the policy of all staff of CUHC [Cooper University Hospital Camden] to maintain compliance with federal and state laws and regulations as well as policies of CUHC related to the prevention, detection, and reporting of loss, theft, or diversion of controlled substances and prescription blanks. ... F. All suspected incidents of drug diversion will be investigated. ...V. POLICY IMPLEMENTATION: ...C. The Drug Diversion Director, Unit or Department Manager, Human Resources, and Director(s) of Pharmacy or designee will collaboratively investigate and respond to reports of medication and/or controlled substance loss, theft, or diversion. D. Diversion of medications and or controlled substances for unauthorized use is prohibited and may lead to disciplinary actions up to and including termination. ...L. Human Resources: 1. Upon discovery of suspected Drug Diversion, Clinical Director/Manager will perform an initial safety assessment to determine whether any patient has been harmed or placed at risk of harm, and immediately determine appropriate action to treat the patient or remove the risk of harm and notify the patient's physician. 2. A team member who is suspected of diversion or being impaired shall be immediately removed from work. The team members access to all Automated Dispensing Machines, Epic, other electronic resources, and controlled substances stock shall be disabled pending investigation or after confirmed diversion or policy breach. Nursing leadership, Drug Diversion Director, and/or Pharmacy Director shall notify the IT [Information Technology] and Security departments to update badge access."

2. On 9/27/23 at 1:53 PM, a tour was conducted on the K10 Medical Surgical Unit with S25, the Assistant Vice President Nursing Operations, S26, the Associate Clinical Director, and S27, the Clinical Director of the K10 Unit. The K10 unit is a 70-bed unit divided into the North and South side. Each side has one medication room that each contains one OmniCell dispensing cabinet. S27 stated, "nurses can float in between sides, but will only be assigned one side per shift." S27 stated that nurses have access to both medication rooms regardless of what side they are assigned to.

On 9/27/23 at 2:00 PM, S44, a Registered Nurse, demonstrated with S27 the process of removing a controlled substance from the K10 North OmniCell cabinet. S44, demonstrated how the OmniCell system uses fingerprint recognition to login to obtain medications. Per S27 and S44, when retrieving a controlled medication, the contents in the individual drawer needs to be counted first and entered into the OmniCell system. S44 stated, "if the controlled medication is going to be wasted there needs to be a second nurse that witnesses the waste process."

On 9/29/23 at 11:55 AM, a tour was conducted on the K10-North unit with S26 and S27. Interviews were conducted with S29, an RN, and S30, an RN. S29 and S30 explained how a Controlled Medication is wasted. S29 stated, "When a controlled medication needs to be wasted, a second nurse is needed as a witness. The second nurse can provide their fingerprint or enter their username and password to sign that they witnessed. If it is a pill or liquid, the waste goes into the Controlled Substance Waste Dispenser. If you only need half of the medication from a syringe, you have to watch the nurse waste the other half into the waste dispenser. If it is a vial, you have to watch the nurse draw up the amount needed and waste the rest in the waste dispenser." S29 indicated that it does not matter "how busy it is" that a waste must be observed by a second nurse. S30 confirmed controlled medications must be witnessed and the process for wasting.

Review of the "Transaction by User" report from the OmniCell Automated Dispensing Cabinet, for the K10 North Unit, from "Date Range 9/9/2023 12:00:00.00 am - 9/10/2023 11:59:59.99 pm ... User Name: (Name) [S31, RN] ..." indicated that S31 wasted Controlled Medications on the following dates and times: 9/9/23 at 7:56 AM; 1:37 PM; 4:54 PM; 6:54 PM; and 9/10/23 at 8:15 AM, 8:38 AM, 9:11 AM, 11:42 AM, 12:01 PM, 2:55 PM, 3:47 PM, 5:34 PM, and 6:03 PM.

A review of the video surveillance of the K10-North Medication Room was conducted with S22, Assistant Director of Security, on 9/28/23 at 2:55 PM and again on 9/29/23 at 9:39 AM and 2:30 PM.

The video surveillance revealed that on 9/9/23 at 7:56 AM; 1:37 PM; 4:54 PM; 6:54 PM; and 9/10/23 at 8:15 AM, 8:38 AM, 9:11 AM, 11:42 AM, 12:01 PM, 2:55 PM, 3:47 PM, 5:34 PM, and 6:03 PM, eight (8) out of eight (8) RN's that entered the K10-North Medication room as a witness for waste during these identified times did not physically watch S31 waste the controlled medication. Eight (8) out of eight (8) RNs used finger recognition as a witness for S31 but did not witness S31 waste the controlled medication into the Controlled Substance Waste Dispenser, either by exiting the medication room before witnessing the waste being performed or remaining in the medication room but not watching S31 dispose of the waste into the dispenser.

The facility policy titled, "3.145-OmniCell Pharmacy," dated reviewed 9/13/22, stated, "... I. PURPOSE A. To provide an accurate and efficient method for the distribution and regulation of controlled substances. ... II. POLICY: A. The OmniCell Pharmacy System is an automated dispensing cabinet that allows medication to be stored and dispensed near the point of care while controlling and tracking drug distribution. ... 4. To Login a. For initial login at the beginning of the shift, the user must enter their User ID [identification] and then scan their fingerprint on each Omnicell cabinet. This shall allow use of fingerprint for login for 12 hours. A user can always login by manually entering their User ID and typing in their password. Also the User ID can be typed in and then your fingerprint can be used when prompted to enter a password. b. If you are within the 12 hour window, the user may login by using just your fingerprint. Finger print login may be used to witness. ... IV. BASIC FUNCTIONS AND DAILY MAINTENANCE: ...D. Wasting Medications: 1. If all or part of a controlled substance dose originally taken from the OmniSupplier has been wasted, it must be documented at the OmniSupplier by using the WASTED ITEM option. This process requires two nurses, the User and a witness. ..."

The facility policy titled, "3.411- Prevention and Suspected Drug Diversion, Theft, Loss, and Reporting Policy," dated reviewed 12/19/22, stated, "1. PURPOSE: A. The purpose of this policy is the following: ... 2. To establish the process for reporting, and investigation of suspected or confirmed events of loss, theft, or diversion of medications, including controlled substances ... X. CONTROLLED SUBSTANCE WASTING: A. If the dispensed quantity or size of the controlled substance is more than the ordered amount, the clinician must waste the remaining portion upon dispensing from the Automated Dispensing Machine, prior to administering to the patient and documenting in the patient EMR [Electronic Medical Record]. 1. This requires a double signature: a. One by the clinician wasting the medication and b. One by a licensed staff (witness) present at the time of withdrawal from the Automated Dispensing Machine and wasting ... E. Controlled Substance Waste should be disposed of: 1. Liquids, injectable, tablets, partial tablets of transdermal patches shall be removed from their packaging and discarded into the CsRx [Controlled Substance Pharmaceuticals] Controlled Substance Waste Receptacle. ..."

According to the above facility policies, the process for the disposal of controlled medication requires a second nurse as a witness. Review of video surveillance identified multiple nurses on the K10-North unit not watching the waste of controlled medications.

On 9/29/23 at 12:13 PM, the information was shared with S25 and S27 that multiple nurses on the K10 unit were identified on video surveillance not observing the waste of controlled medications by S31. S25 and S27 confirmed that controlled medications that are not disposed of properly could result in loss, theft, or diversion which could result in patients not receiving the correct medication.

Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that drugs were kept in a secure area to prevent unmonitored access by unauthorized individuals.

Findings include:

A review of Patient (P) 4's medical record indicated the following information:

On 9/6/23, P4 presented to the facility Emergency Department (ED) at 6:33 AM, with complaints of dizziness, diarrhea for two days, sinus pressure, and increased blood pressure upon arrival. P4's facesheet identified P4 as a facility employee. P4 was roomed in the ED at 6:48 AM, seen by an ED provider at 7:21 AM, and was admitted for observation on 9/6/23 at 12:03 PM. At 11:30 PM, Staff (S) 45, an ED provider, was noted to be called to the bedside by the patient's registered nurse (RN) for "... Patient found with [his/her] head slumped, with [his/her] scrub top wet, and deep sonorous respirations. [He/She] had [his/her] IV [intravenous] site in place. with a partially pushed syringe of a medication that was milky white in color still attached ... the patient after about 2 minutes slowly regain consciousness, and appear [sic] to wake up. [He/She] then deflty [sic] while moving blankets disconnected and emptied the syringe ..."

On 9/7/23 at 7:30 AM, S46, an ED nurse, documented, "... Pt ... appears to be under the influence of unknown substance ... ." At 9:00 AM, S46 documented, "... syringe found on patients bed with unknown substance, flow nurse [S50, ED Flow Manager] notified and given syringe ..."

On 9/27/23 at 12:18 PM, S5, the Drug Diversion Director, confirmed that P4 was a surgical technician at the facility. Upon request to the facility, P4's badge access report was provided for review for the dates of 9/6/23 and 9/7/23. From the time P4 presented to the ED on 9/6/23 at 6:33 AM to the time P4 was discharged from the ED on 9/7/23 at 5:29 PM, the badge swipe access report showed that the patient left the ED to swipe into areas of the Operating Room (OR) suite on nine different occasions. Two out of those nine occasions, P4 attempted to swipe into an OR medication room, but P4's access was rejected. This information was shared with S5, who stated that he/she had not thought to pull and review the badge swipe access record for P4. S5 was not aware that P4 had left the ED to return to the OR on 9/6/23 and 9/7/23.

A tour of the OR suite was conducted on 9/28/23 at 12:08 PM. S17, Registered Nurse (RN), stated that medications in the OR are stored in the top four drawers of the OmniCell. Surgical technicians do have access to the OmniCell, but not to the top four drawers that contain medications. During the tour of an unoccupied OR, a black container was observed to be on the floor of the OR. The black container contained syringes, with needles still attached. Four syringes contained varying amounts (5 mL (milliliters), 20 mL, 7 mL, and 10 mL) of a milky white medication that was labeled propofol. The black container had a cover that had a circular opening on top. The circular opening had a door that slides to close but does not lock. S18, RN, stated that the black box opening is covered each night and is not emptied or moved to a secure room.

Medications, such as Propofol, are secured in the OmniCell with limited access prior to administration. After administration, the unused portion of the medication is discarded in the administration device the drug was in contact with (a syringe with needle attached) into the black hazardous pharmaceutical waste container. The black pharmaceutical waste container does not have a locking mechanism to prevent access to the discarded medication. The facility does not have a policy or procedure for the limiting of access and protection of the discarded medication; thus this medication is accessible to others that would not otherwise have access to this medication. Failure to continue to limit access to the unused discarded medication or secure the unused portion of the medication in the syringe would increase the likelihood that the medication could be removed from the black pharmaceutical waste container and used for a purpose not in adherence with a prescriber order by someone that who would not otherwise have access to the medication.