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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services was out of compliance.

C-1016 [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. Based on observations, interviews, and document review, the facility failed to ensure medications were stored and secured according to facility policy. Specifically, the facility failed to ensure medications were stored securely to prevent unauthorized access in one of one Infusion Clinics observed. In addition, the facility failed to ensure medications were securely discarded. Specifically, the facility failed to ensure biohazardous (any biological or chemical substance dangerous to humans, animals, or the environment including body fluids, human tissue and blood) and medication waste was secured to prevent unauthorized access in three of three large sharps collectors with sliding tops observed.

Based on observations, interviews, and document review, the facility failed to ensure medications were stored and secured according to facility policy. Specifically, the facility failed to ensure medications were stored securely to prevent unauthorized access in one of one Infusion Clinics observed. In addition, the facility failed to ensure medications were securely discarded. Specifically, the facility failed to ensure biohazardous (any biological or chemical substance dangerous to humans, animals, or the environment including body fluids, human tissue and blood) and medication waste was secured to prevent unauthorized access in three of three large sharps collectors with sliding tops observed.

Findings include:

Facility policies:

The policy Medication Security read, all medications and biologicals stored in this hospital shall be kept in a secure area, locked when appropriate and accessible only to authorized staff. A secure area is defined as any area that prevents unauthorized individuals unmonitored access.

Authorized staff allowed access to the pharmacy include pharmacists, pharmacy technicians, pharmacist interns under the direct supervision of a pharmacist (PharmD), E.D. technicians, respiratory therapists, and approved registered nurses (RN). Others are admitted only when pharmacy staff is present. When unattended, the medication carts and medication rooms are to be locked.

The policy Handling of Sharps Safe Work Practice read, precautions: all sharps and broken glass must be disposed of in designated sharps containers.

Reference:

The BD Sharps Collector with Sliding Top IFU read slide door back to open for disposal. Slide door forward to cover opening and engage temporary closure.

1. The facility failed to ensure medications were stored securely and not available to unauthorized staff.

a. On 3/28/23 at 11:35 a.m., an observation of the medication room at the Infusion Clinic revealed an unlocked medication refrigerator stocked with medications. The refrigerator had a keyhole in the handle, indicating it could be locked. At 11:50 a.m., after being asked if the refrigerator was ever locked and demonstrating the keyhole, registered nurse (RN) #2 left the room and returned with a key which she used to lock the refrigerator.

b. On 3/29/23 at 2:47 p.m., an interview was conducted with environmental services staff (EVS) #5. He stated he had a key to the Infusion Clinic medication room and cleaned the room daily after 9:00 p.m. EVS #5 stated he was alone while cleaning the medication room.

c. On 3/29/23 at 2:39 p.m., an interview was conducted with the environmental services director (Director) #4. He verified housekeeping had a key to the medication room and cleaned the room each night.

d. On 3/28/23 at 11:51 a.m., an interview was conducted with nurse practitioner (NP) #1. She stated the medication room at the Infusion Clinic was locked overnight when staff was absent; however, housekeeping had a key to the medication room in order to clean when patients were not being seen. NP #1 stated the medication refrigerator in the medication room was never locked and she had not been aware there was a way to lock the refrigerator. NP #1 stated the types of medications stored in the refrigerator were used to treat autoimmune conditions, osteoporosis, anemia, and other diseases. She stated the risks of someone diverting (the illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber) the medication from the unlocked refrigerator included chills, fever, anaphylaxis (severe, potentially life-threatening allergic reaction), cardiac arrest (sudden loss of all heart activity due to an irregular heart rhythm), and death.

e. On 3/29/23, at 7:57 a.m., an interview was conducted with pharmacist (Pharmacist) #3. He stated he inspected the Infusion Clinic periodically to make sure stock was rotated. Pharmacist #3 stated the medication room was locked when staff were not present in the room but he was not aware the medication refrigerator was kept unlocked. He stated it was important to keep the medication refrigerator locked. He also stated the risks of taking the medications included nausea, vomiting, allergies, and death.

2. The facility failed to ensure medications were discarded securely and not available to unauthorized individuals.

a. Observations of the facility

i. On 3/27/23 at 11:35 a.m., an observation at the Infusion Clinic revealed a large red biohazardous container sitting unsecured on the floor with a wide open lid. A medication bottle and needles were visible through the opening. The opening was large enough to reach in with one or both hands and retrieve discarded items. Furthermore, the container was unsecured and could have been picked up and carried away.

ii. On 3/27/23 at 2:30 p.m., an observation in the emergency department (ED) trauma bay revealed a large red biohazardous container with a wide open lid. Medication bottles with tubing, syringes, and needles were visible through the opening. The opening was large enough to reach in with one or both hands and retrieve discarded items.

iii. On 3/28/23 at 12:04 p.m., an observation in operating room (OR) suite #2 revealed a large red biohazardous container sitting unsecured on the floor with a wide open lid. Syringes containing medication waste, bottles and tubing were visible through the opening. The opening was large enough to reach in with one or both hands and retrieve discarded items. Furthermore, the container was unsecured and could have been picked up and carried away.

b. Interviews

i. On 3/27/23 at 2:30 p.m., an interview was conducted with the assistant vice president of nursing (AVP) #6. She stated the large sharps container in the ED Trauma Bay was used to dispose of items that would not fit in the smaller sharps containers attached to the wall. AVP #6 used examples of Propofol (anesthetic medication that causes relaxation and sleepiness) bottles, and tubing as items discarded in the containers.

ii. On 3/28/23 at 1:09 p.m., an interview was conducted with environmental services director (Director) #4. He stated these types of large sharps containers were used only in secure areas under direct observation and did not believe there was an opportunity for diversion.

iii. On 3/29/23 at 1:05 p.m., an interview was conducted with the infection control coordinator (Coordinator) #7. She stated the large opening in the large sharps container could have been a risk for medication diversion and exposure to blood and body fluids.

iv. On 3/29/23 at 3:50 p.m., an interview was conducted with the ED director (Director) #8. She stated it would be possible for a partial bottle of medication to be discarded in the large sharps container in the trauma bay. She also stated it was possible for an individual to enter the trauma room unobserved by staff and there was potential for someone to obtain medication from the unsecured container. Furthermore, she stated the large sharps container in the trauma bay had a door that should have been slid shut to prevent unauthorized access.

Upon request, the facility was unable to provide a policy for securing the sharps containers and the contents, which included medical waste, from unauthorized persons.