HospitalInspections.org

Based on document review and observations the Facility failed to maintain the minimum requirements for sterile compounding as outlined in the United States Pharmacopeia (USP) 797 authoritative guideline, at two sterile compounding sites of the Hospital.

Findings include:

On 01/17/19, the Surveyor observed at the compounding pharmacy located at 123 Summer St (within basement pharmacy department):

1) Sprinkler covers not flush to ceiling, crack of space observed between ceiling and hanging sprinkler covers.

2) Dirty floor indicated by the appearance of hair strands located to the left of the Compounding Aseptic Containment Isolator (CACI).

3) Paint chipping on lower edge of wall near CACI.

4) Daily Pressure Monitoring was not conducted (either by daily log or continuous recording device) between the garbing/ante area of the compounding room and the pharmacy department.

5) Review of the environmental monitoring report, dated 10/18/2018, did not indicate any documentation of minimum displacement airflow of 40 ft per minute or more from the buffer area across the line of demarcation into the ante-area (open architecture design requirement).

6) Failure to follow Waste Disposal Policy.

The document titled Waste Disposal, effective 06/26/18, states appropriate wasting of medications based on color coded bins. The document states that the blue bin is for used medications/partially used vials, sharps to be placed in purple or red bins, cytotoxic materials containing less than 3% total volume in yellow buckets and cytotoxic materials containing greater than 3% total volume in black buckets.

On 01/17/19, the Surveyor observed used vials inside the purple bin.

The Surveyor interviewed Pharmacy technician #2 on 01/17/19 regarding the improper wastage of used vials in the purple bin. Pharmacy technician #2 stated that there are newly hired employees who may be unaware of the right procedure.

On 01/18/19, the Surveyor observed the following at the St. Vincent Cancer and Wellness Center compounding pharmacy located at 1 Eaton Place, Worcester, MA 10608:

1) In the hazardous buffer room, ceiling light fixtures are not smooth, mounted flush or sealed.

2) Failure to supply powder-free sterile gloves for personnel use in both the hazardous and non-hazardous buffer rooms.

3) Observed pharmacy personnel taking hazardous medications with bare hands from the hazardous storage area to the pass through window located between the anteroom and hazardous buffer room without donning chemotherapy gloves first.

4) Failure to maintain at least 0.02 inches water gauge positive pressure from the anteroom to the unclassified pharmacy work space of the hazardous compounding section. The Surveyor observed a spot reading of 0.012 positive pressure from the anteroom to the unclassified pharmacy work space.

5) Failure to provide an alcohol-based surgical hand scrub in the anteroom to the non-hazardous compounding section.

6) Daily Pressure Monitoring was not conducted (either by daily log documentation or continuous recording device) for both the hazardous and non-hazardous compounding spaces.

The Surveyor observed upon opening the door between the non-hazardous buffer room and the anteroom, when the positive pressure fell below 0.02 inches water gauge, there was no indication of alarm to the wall console system. The Surveyor visibly observed a drop in pressure below 0.02 inches water gauge and there was no alert by the system.

Based on record review, the Hospital failed to document in the medical record medication errors that occurred to Patient #2 and Patient #3.

Findings include:

The medication incidents report, dated 01/17/19, indicated that Patient #2 received the incorrect concentration of the drug Levophed (a vasoconstricting drug used to treat low blood pressure and shock) on 11/21/18.

Review of the medical record for Patient #2 did not indicate documentation of the incorrect Levophed concentration event.

The Surveyor interviewed the Clinical Risk Manager and the Quality and Patient Safety Director on 01/18/19 at 10:45 A.M. The Clinical Risk Manager and Quality and Patient Safety Director said that Patient #3 received Solu-Medrol (a steroid drug) but was scheduled to receive Ocrevus (a biological drug for multiple sclerosis) in error.

Review of the medical record for Patient #3 did not indicate documentation that Patient #3 received Solu-Medrol instead of the intended drug, Ocrevus.