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Based on observation, interview, and policy review, the provider failed to ensure medications had been properly monitored and secured to prevent unauthorized access to them in one of one operating room (OR). Findings include:

1. Observation on 9/17/19 at 9:30 a.m. with the OR supervisor revealed:*A large opaque Sharps container (approximately eighteen inches tall by twelve inches wide) was placed on the anesthesia cart.
*The container:
-Had not been secured to the cart.
-Was approximately one-third full of medication vials.
*Further observation of the multiple vials inside the container had included fentanyl, glycopyrrolate, and propofol.
-One observed vial of glycopyrrolate had been half full.

Interview at that time with the OR supervisor revealed:*The OR room was secured with a key code door lock.
*All nurses and housekeepers had access to the code.
*The anesthesia cart was secured.
*The Sharps container was not secured.
*The anesthetist's medications were checked out of the pharmacy prior to surgery.
*The provider now had black box containers for disposing empty medication vials.
-Any vials with remaining medications were to have been emptied by two licensed staff and disposed of in the black box container.
*The medication inside the vials were to have been documented when disposed of.
*The Sharps container located in the OR had been there for a "long time."
-She was not sure how long the container had been there.
*She confirmed the medication in the opaque Sharps container had not been secured or disposed of properly.

Interview on 9/17/19 at 3:15 p.m. with the pharmacist regarding security of the medication revealed:
*She had not monitored the OR area for drug security.
*The provider's policy was for all narcotic medications to be removed from vials and destroyed in RX Destroyer and then that destroyer returned to the pharmacy.
*Other medications were to have been destroyed in the RX Destroyer or placed in a black pharmaceutical hazardous waste container.
*She confirmed:
-Vials containing medication should not have been left in the Sharps container.
-Those medications were not secured.

Interview on 9/18/19 at 10:00 a.m. with the director of nursing confirmed the medication in the OR Sharps containers were not secured.

Review of the provider's July 2019 Hazardous Waste Disposal policy revealed:
*Pharmaceutical waste including partial, unused pharmaceuticals were to have been placed in a black hazardous waste container.
*RX Destroyer directions included:
-Medications up for destruction were to have been documented through Acudose or on the Controlled Substance Administration Record, and then placed into the RX Destroyer.
-Full RX Destroyer bottles were to have been placed in black pharmaceutical containers.

Review of the provider's September 2018 Sharps Disposal policy revealed:
*Sharps boxes were classified as regulated medical waste including needles, syringes containing blood or body fluid, scalpel blades, sharp instruments, discarded broken glass, and discarded vaccines.
*The policy had not included disposal of medication.
*Sharps boxes were to have been wall-mounted or secured to maintain boxes in an upright position.

Based on observation, interview, policy review, and professional standards, the provider failed to ensure three of three medication passes by two of two registered nurses (RN) (A and B) for one of one patient (18) and one of one outpatient (29) were completed following professional standards. Findings include:

1. Observation and interview on 9/17/19 at 9:00 a.m. with patient 18 and RN A revealed:
*The patient was scheduled to receive eight medications.
*RN A:
-Brought the scheduled medications to the patient's room.
-Identified the patient.
-Verified each medication to be administered in the Electronic Medical Record (EMR) in the patient's room.
-Scanned each package of medication to be given.
--As each package of the patient's medication was scanned RN A clicked "Accepted" on the computer screen.
--Once "Accepted" was clicked on the screen indicated "Given."
*RN A confirmed once she clicked on Accepted the EMR showed the medication had been given.
*Then RN A gave the medications to the patient.

Further interview at that time with RN A revealed if a patient refused a medication after she had charted the medication had been given, the system allowed her to go into the EMR and amend that documentation.



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2. Observation on 9/17/19 at 10:50 a.m. of RN A during a medication pass to patient 29 revealed:
*RN A:
-Brought the medication into the infusion room.
-Identified the patient.
-Verified the medication to be administered using the EMR located in the patient's room.
-Scanned the package of medication to be given.
-Answered any questions in the EMR that were presented by it.
-Clicked "Accepted" on the bottom of the screen after completing the documentation.
--Once the "Accepted" button was clicked the screen indicated "Given."
*RN A then gave the medication to the patient.

3. Observation on 9/17/19 at 11:30 a.m. of RN B during a medication pass to patient 18 revealed:
*RN B:
-Brought the medication into the patient's room.
-Identified the patient.
-Verified the medication to be administered using the EMR located in the patient's room.
-Scanned the package of medication to have been given.
-Dialed the correct dose of insulin.
-Answered any questions in the EMR that were presented by it.
-Clicked "Accepted" on the bottom of the screen after completing the documentation.
--Once the "Accepted" button was clicked the screen indicated "Given."
*RN B then gave the medication to the patient.

4. Interview on 9/17/19 at 11:35 a.m. with RN B and RN A regarding documenting the medication was given prior to administration revealed both RNs:
*Confirmed they routinely answered any questions on the EMR and then pressed the "Accepted" button prior to administering medication to the patients.
*Stated they needed to push the "Accepted" button, so they could move on to other areas in the EMR.
*Were aware the "Accepted" button was confirming the medication had been administered prior to actually administering that medication.
*Stated if for some reason the medication had not been given at that time they could push an amend button to remove the documentation, and then document why it was not given.

Interview on 9/18/19 at 12:45 p.m. with the director of nursing regarding the above observations confirmed:
*Pushing the "Accepted" button in EMR indicated the medication had been given.*The EMR system allowed the user to enter and exit the medication being reviewed without clicking the "Accepted" button.
-The nurse administering medications would have been able to review and document answers to the questions in each medication entry without pushing the "Accepted" button.
-After all medications were reviewed and administered the nurse would have been able to return to the EMR and push one "Accepted" button that would have documented all the medications reviewed had been given.
*The nurses should have always given the medication prior to documenting the medications had been administered.

Review of the provider's September 2019 Medication Administration Record (MAR) policy revealed:
*Medications were to have been administered and documented "in adherence with South Dakota Codified Laws, Statutes, Professions and Occupations facility policy and defined scopes of practice appropriate to the discipline."
*Documentation would occur after the medication was administered or as soon as possible thereafter.
*The actual time of administration was to have been documented on the MAR.