Bringing transparency to federal inspections
Tag No.: C0914
Based on observation, interview and record review, the facility failed to follow their established policies and procedures; and failed to perform timely preventive maintenance for two "Vapotherm high-flow respiratory support systems." Findings include:
During an observation and interview on 2/13/24 at 1:40 p.m., a Vapotherm, model, "Precision Flow Plus," serial number PFPC00048536-E, was noted to have a preventive maintenance sticker reflecting an inspection on 2/2021, and a next due inspection of 2/2022. Staff member P was unable to find a current inspection sticker and said he did not know if the machine had had a more recent preventative maintenance.
During an observation and interview on 2/13/24 at 1:44 p.m., a Vapotherm, model, "Precision Flow Plus," serial number PFPC00042152-E, was noted to not have a preventive maintenance sticker. Staff member P said he was unaware of when or if the machine had had any preventative maintenance.
During an interview on 2/15/24 at 9:25 a.m., staff member Q stated there were no current preventative maintenance records for the two Vapotherm machines.
During an interview on 2/15/24 at 9:55 a.m., staff member Q stated the machines were purchased in 2020 and stated, "I don't think there has been a pm since they were purchased." Staff member Q stated each department head makes sure the machine maintenance was done on their department's equipment. Staff member Q stated, "I don't think [staff member P] knows about the service contracts, he's new."
A review of a facility policy titled, "Plant/Maintenance," with a revised date of 5/6/20, showed:
-"Purpose:
-To ensure that all essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition.
-Policy: ...
-... Preventive maintenance: The preventive maintenance program is provided by the maintenance department either directly or through the use of a contract service or the equipment vendor. Schedules and records are maintained. ..."
Tag No.: C0922
Based on observation, interview, and record review, the facility failed to ensure the medication room, located in the oncology infusion center, was locked at all times. Findings include:
During an observation on 2/13/24 at 9:38 a.m., staff member I was seated next to an infusion patient, with her back to the entrance of the oncology infusion center entrance doors, which were open.
During an observation and interview on 2/13/24 at 9:38 a.m., staff member E opened the medication room door in the oncology infusion center, and entered the room. The medication room door was not locked to restrict unauthorized personnel. Staff member E stated the door to the medication room was not kept locked when nurses were present in the oncology infusion center.
During an observation on 2/13/24 at 9:45 a.m., the following medications were observed on an open shelf in the oncology infusion medication room:
-Five boxes of Palonosetron (a medication used to treat nausea and vomiting) 0.25 mg/5ml;
-Three boxes of Abraxane (a chemotherapy medication) 100 mg vial;
-One box of Docetaxel (a chemotherapy medication) 160 mg/8 ml; and
-One box of Gemcitabine (a chemotherapy medication) 20 mg vial.
During an observation on 2/13/24 at 9:45 a.m., the oncology infusion medication room refrigerator was inspected. Multiple boxes/containers of chemotherapy medications were observed being stored in the refrigerator.
During an interview on 2/13/24 at 9:55 a.m., staff member I stated the door to the pharmacy/medication room in the oncology infusion center was always unlocked during the day when the center was open, Monday - Friday, 7:00 a.m. - 3:30 p.m.
Review of the facility's policy titled, Antineoplastic Medications, last revised 4/19/23, showed:
- ... "12. When the OCP (Oncology Center Pharmacy) is not in use, access shall be restricted via locking the outer door with only pharmacy personnel and the infusion nurse having direct access. ..."