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41 HIGHLAND AVENUE

WINCHESTER, MA 01890

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observations, records reviewed and interviews the Hospital failed to consistently adhere to accepted standards of care for medication storage, checking of emergency equipment and use of biohazard bags.

According to the Hospital policy titled "Multiple Use of Products", revised July 2019, Insulin vials are dated with a 28 day expiration either when opened or when removed from refrigeration.

1.)The Surveyor reviewed the automated medication dispenser in the Post-Acute Care Unit (PACU) with PACU RN #1 at 8:40 A.M. on 9/14/2020. PACU RN #1 said that when a patient required an insulin dose in any of the peri-operative areas it would be retrieved from the automated medication dispenser located in the PACU. PACU RN #1 demonstrated how the multi-dose vial of insulin was stored. PACU RN #1 said that insulin no longer required refrigeration but was dated for 28 days when the vial was opened. The unopened vial had no date to indicate when it had been removed from refrigeration or its' expiration date.

2.)The Surveyor toured the Operating Room (OR) at 7:30 A.M. on 9/14/2020 with the Nurse Manager. The Surveyor toured the OR core area (a restricted space for sterile storage) and observed 8 biohazard bags with various clean unused laboratory tubes stored inside. Biohazard bags are used for transport of potentially infectious material. The Nurse Manages said that the laboratory tubes should be stored in a clear bag.

3.)The Surveyor toured the Day Surgery Holding are at 7:15 A.M. on 9/14/2020 with the ACNO of Surgical Services. The Surveyor observed two code carts (emergency equipment) one for adult and one for pediatric emergencies. The Code Cart Check List indicated that the carets were to be checked daily. The sign-off sheets for the Adult Code Cart indicated it had not been signed off on 9/11/2020 and the Pediatric Code Cart had not been signed off on 9/11, 8/11, 8/12, 8/17, 8/19, 8/26, 8/27, 8/28/2020.

INFORMED CONSENT

Tag No.: A0955

Based on records reviewed an interview the Hospital failed to perform comprehensive informed consent for 1 of 5 patients (Patient #2).

According to the Hospital's informed consent form titled "Request for Surgical or Medical Procedures" undated, Allied healthcare professionals may be present and assist the staff during operative procedures. Other authorized individuals may occasionally be present during surgery, such as students and surgical supply/manufacture representatives.

The Surveyor interviewed CRNA #1 at 11:00 A.M. on 9/14/2020. CRNA #1 said that the Medical Student was just finishing suturing Patient #2's vagina when Patient #2 began to restlessly awaken. A review of Patient #2's informed consent failed to indicate that the Medical Student would be participating in the care of Patient #2.