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Based on observations, records reviewed and interviews the Anesthesia Services failed to comply with the Hospital policies for the surgical time out (surgical time out represents the last step of the Universal Protocol when just prior to the start of the procedure the surgical team verifies the accuracy of the patient, the procedure and the site) and the preparation of medications according to sterile compounding United States Pharmacopeia (USP) standards of care.

Findings included:

1.) According to the Hospital policy titled "Universal Protocol: Time Out and Site Verification" dated 1/9/2020, during the time out other activities are suspended, to the extent possible without compromising patient safety, so that all relevant members of the team are focused on the active confirmation of the Patient identification, procedure, site and side.

The Surveyor observed the surgical time out in Operating Room #1 at the Waltham Surgical Center at 2:48 P.M. on 6/30/2020. The time out was announced by the Circulating Nurse. Anesthesiologist #1 was holding two medication syringes in his hand and continued to disinfect the entry point on the intravenous tubing during the time out pause instead of stopping all activity as the policy required. The Surveyor interviewed the Nurse Director at 2:50 P.M. on 6/30/2020. The Nurse Director said that she would expect Anesthesiologist #1 to stop all activity during the surgical time out.

2.) According to USP 797 Second Supplement to USP 42-NF 37 (United States Pharmacopeia establishes written for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency and USP is the Pharmaceutical Agency that sets the standards for sterile compounding)

The Surveyor observed an intravenous solution spiked and hung in the pre-surgical holding area at 2:50 P.M. on 6/30/2020. The Solution of Lactated Ringers was unlabeled but the tubing read 6/30/20 at 6:30 A.M. The Nurse Director said that the Anesthesia Department spiked the intravenous solutions in the morning and then used them over the course of the day. The Nursing Director said that a case had been canceled so there was one intravenous set up left over.

According to the current USP standards when an intravenous solution is spiked administration of the solution begins within 4 hours following the start of preparation. If administration has not begun within 4 hours following the start of preparation, it must be promptly, appropriately, and safely discarded.